1 1 MONTANA FIFTH JUDICIAL DISTRICT COURT BEAVERHEAD COUNTY 2 3 TRINA HEALTH OF MONTANA, LLC, HAROLD LARON BRIGGS, BARRY BRIGGS, and HAROLD L. GROGAN, 4 Plaintiffs, 5 vs. 6 7 HEALTH CARE SERVICE CORPORATION d/b/a/ BLUE CROSS AND BLUE SHIELD OF MONTANA, 8 Defendant. 9 ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Case No. DV 14044 10 TRANSCRIPT OF HEARINGS CASCADE COUNTY COURTHOUSE 415 SECOND AVENUE NORTH GREAT FALLS, MT 59401 January 31, 2018 and February 2, 2018 11 12 13 HONORABLE ELIZABETH BEST, PRESIDING JUDGE 14 APPEARANCES 15 For Trina Health: Erin MacLean, Attorney at Law Freeman & MacLean 44 W. 6th Avenue, Suite 210 Helena, MT 59624 January 31, 2018 only Laurie Zmrzel, Attorney at Law 5112 Bailey Loop McClellan, CA 95652 For Blue Cross and Shield: Kimberly Beatty, Attorney Dan Auerbach, Attorney at Browning, Kaleczyc, Berry 800 N. Last Chance Gulch, Helena, MT 59601 16 17 18 19 20 21 22 23 24 25 JOSLYN CUMMINGS OFFICIAL COURT REPORTER 228 Broadway Helena, MT 59601 (406)447-8267 jocummings@mt.gov at Law Blue Law & Hoven, PC No. 1 2 1 I N D E X 2 WITNESS 3 Julie Briggs DX by Ms. MacLean........... CX by Mr. Auerbach.......... RDX by Ms. MacLean.......... RCX by Mr. Auerbach......... 4 5 6 7 P. P. P. P. 33 60 86 88 Barry Briggs DX by Ms. MacLean........... P. 90 CX by Mr. Auerbach.......... P. 106 RDX by Ms. MacLean.......... P. 110 8 9 10 11 12 13 14 Harold Grogan DX by Ms. MacLean........... P. 112 Dr. John Palmer Elliott DX by Ms. MacLean........... CX by Mr. Auerbach.......... RDX by Ms. MacLean.......... RCX by Mr. Auerbach......... P. P. P. P. 123 162 198 208 Taylor Romine DX by Ms. MacLean........... P. 216 CX by Mr. Auerbach.......... P. 242 RDX by Ms. MacLean.......... P. 248 15 16 17 18 19 Dr. Jean-Pierre Pujol DX by Ms. Beatty............ P. 252 CX by Ms. MacLean........... P. 281 RDX by Ms. Beatty........... P. 300 Jamie Smith DX by Ms. Beatty............ P. 302 CX by Ms. MacLean........... P. 313 20 EXHIBITS ADMITTED INTO EVIDENCE 21 22 23 Hearing Hearing Hearing Hearing Exhibit Exhibit Exhibit Exhibit No. 1.......... No. 2.......... Nos. 3 & 4..... No. 5.......... P. 58 P. 99 P. 103 P. 124 24 Petitioner Exhibit Nos. 1 - 10 25 P. 131 3 1 (The following proceedings were held in open 2 court on January 31, 2018:) 3 4 THE COURT: So this is Cause No. DV-17-14044 in 5 the Montana Fifth Judicial District Court in Beaverhead 6 County. 7 not all and I am just going to identify the parties that I 8 believe are present or the counsel who are present so that we 9 can make sure -- Hold on one moment. My name is Judge Best. I have met some of you but My court reporter is 10 just turning on the courtroom recording system. It's her 11 backup for redundancy and it's probably a good idea. 12 So this is Trina Health of Montana, LLC, 13 Harold Laron Briggs, Barry Briggs, and Harold L. Grogan. 14 They are represented by Erin MacLean, who is present in 15 Dillon, and she is from Freeman & MacLean out of Helena and 16 also I hope I pronounce this correctly, Laurie Zmrzel; is 17 that right? 18 MS. ZMRZEL: 19 THE COURT: 20 MS. ZMRZEL: 21 THE COURT: Perfect, yes, your Honor. You are from, I believe, California? Southern California. Thank you. I see that you have been 22 admitted pro hac vice in the previous proceeding. Also 23 present on behalf of the defendant Healthcare Service 24 Corporation doing business as Blue Cross/Blue Shield of 25 Montana. 4 1 The defendants are represented by Kimberly Beatty 2 and Daniel Auerbach, who are from Missoula and as I 3 understand it, Christy McCann is also counsel of record and 4 she is not here today. 5 6 MS. BEATTY: She is not here today. For the record, your Honor, I am actually in our Helena office. 7 THE COURT: And I may ask you, this may feel a 8 little bit awkward, and Jane do you have that microphone that 9 goes with that stand? It should be sitting down there 10 somewhere. We are just managing sound here so that everyone 11 can hear each other so my clerk is handing Ms. Beatty the 12 microphone. 13 (Off the record.) 14 MS. BEATTY: 15 Your Honor, if it's okay with you, I'll just move around so I can find a microphone. 16 THE COURT: 17 MS. BEATTY: Feel free. Christy McCann is one of our 18 attorneys in our Missoula office with Mr. Auerbach. 19 not here today. 20 Helena office. 21 out of Missoula, I am in Helena. She is And my office, technically I am in our Even though the pleadings have been issued 22 THE COURT: Understood. Thank you. 23 And Mr. Auerbach is also in Missoula? 24 MR. AUERBACH: 25 THE COURT: Yes, your Honor. All right. Thank you. Not that it 5 1 matters, I guess, but just to make sure I know who is in the 2 courtroom. 3 So where we are procedurally, and also just so 4 everyone can see the other person who is on the screen, that 5 person is John Elliott, who is in Dallas, Texas. 6 Can you hear me okay, Mr. Elliott or Dr. Elliott? 7 DR. ELLIOTT: 8 THE COURT: 9 10 All right. muted right now; is that right? Thank you. And you are I think Ms. MacLean asked you to mute yourself? 11 12 Yes, your Honor, I can. DR. ELLIOTT: I think I am not muted but I will be very quiet. 13 THE COURT: Okay. And the only reason I think she 14 would ask that is not only for the noise but sometimes we get 15 feedback. 16 okay. 17 18 So far, we haven't gotten any so we should be DR. ELLIOTT: If there is, your Honor, I will try to figure out how to do that. 19 THE COURT: All right. Thank you. All right. 20 Procedurally, I won't have the precise dates but 21 back in October, I believe, the plaintiffs filed a petition 22 for a TRO and a preliminary injunction, as well as for 23 declaratory judgment. 24 Berger and then this matter was removed to federal court. 25 was thereafter remanded and then a substitution of judge The TRO was initially granted by Judge It 6 1 occurred and we are here now on a renewed request for 2 preliminary injunction. 3 grant the TRO again in advance of this hearing and I do 4 understand because of the nature of injunctions in general 5 and restraining orders in general, this is difficult for 6 everyone to make but I think in terms of the legislative 7 policy, moving promptly on this is the appropriate thing to 8 do. 9 And I did grant the continuation or And I will warn parties in advance that as we go 10 forward, it's going to be difficult or a challenge; let's 11 think of herding cats getting another date on the calendar so 12 you may find me just arbitrarily setting something but I will 13 try to work with people's schedules as well. 14 So Ms. MacLean, this is your petition. 15 look like you are all over this but I just want to make sure, 16 I may stop you periodically, I have a have a court reporter 17 here who I don't think you can see but she is taking down the 18 record so if I stop you, it's probably going to be because of 19 sound so I will just ask everyone to take turns and if you 20 have an objection, let me know, understanding that there is 21 no jury here so there will be some latitude granted and I 22 will allow you to proceed. 23 So you I don't know if you want to make argument first. 24 I have read the briefs. I won't tell you I have every 25 document in the file memorized but I am generally familiar, I 7 1 think, with what you are doing here. 2 MS. MacLEAN: Thank you, your Honor. A short 3 opening statement. May it please the Court and counsel, the 4 plaintiffs filed a petition for declaratory judgment along 5 with a request for injunctive relief on October 23, as the 6 Court indicated originally. 7 Health Montana, LLC or we will refer to that entity as Trina 8 or Trina of Montana, your Honor, a small clinic located in 9 Dillon, Montana that's licensed to provide what's called The current plaintiffs are Trina 10 Artificial Pancreas Treatment using the Microburst Infusion 11 Insulin Therapy. 12 13 THE COURT REPORTER: I'm having a hard time hearing. 14 THE COURT: 15 Did you say too fast? 16 THE COURT REPORTER: 17 18 Hang on. Ms. MacLean, one moment. Too fast and I don't know; If she could speak up. THE COURT: You probably can't tell that mic is 19 super fuzzy and so if you will just slow down, but are there 20 any other mics in the room? 21 MS. MacLEAN: 22 THE COURT: 23 24 25 Is this mic better. That's a little bit better and I don't mind if you sit down. MS. MacLEAN: Okay. If you don't mind if I sit down, I will sit down, your Honor. 8 1 THE COURT: That's fine. 2 MS. MacLEAN: So I will go back to say that the 3 Dillon clinic's license to provide Artificial Pancreas 4 Treatment with the Microburst Infusion Insulin Therapy 5 technology and we short that as A as in apple, P as in pear, 6 T as in Tom, forward slash, M as in Mary, I as in insulin, I 7 as in insulin. 8 9 10 So when I say APT/MII, that's what I mean. The other two plaintiffs here other than Trina are patients of Trina in Dillon who are diabetics covered by Blue Cross/Blue Shield Montana Insurance Plan. 11 THE COURT: I am going to stop you one more time. 12 I apologize but Dr. Elliott, can you turn your I-Pad all the 13 way down? 14 the I-Pad. I think what we are getting is a lot of sound from 15 16 MR. ELLIOTT: Let me try to do that, your Honor. 17 18 Okay. THE COURT: And we may, Ms. Ms. MacLean, this is your witness, Dr. Elliott? 19 MS. MacLEAN: Yes, ma'am. 20 DR. ELLIOTT: I'm just going to turn it off, your 21 Honor. 22 turn it back on. 23 You will have to signal me somehow that I need to THE COURT: All right. And I can even allow 24 Ms. MacLean time to call you but that helps a lot, at least 25 on this end. I think we may have to ask him to just, unless 9 1 you need him to listen to this, to just turn it off. 2 3 MS. MacLEAN: the testimony, your Honor. 4 5 THE COURT: on this end. 6 7 It's just a lot of noise here It's hard to hear you. Dr. Elliott, can you find Eric to turn it down? DR. ELLIOTT: I can turn it down. You just want it down? 10 11 Okay. MS. MacLEAN: 8 9 And I was hoping he would listen to THE COURT: end. I want all of your noise off on your That's better. 12 MR. ELLIOTT: 13 THE COURT: 14 DR. ELLIOTT: 15 THE COURT: 16 DR. ELLIOTT: Speak, Erin. 17 MS. MacLEAN: Can you hear me? 18 DR. ELLIOTT: Yes, I can hear both of you. 19 Is that better? Yeah, that's way better. I can't hear you now so -- All right. have to pay close attention. 20 THE COURT: Okay. 21 MS. MacLEAN: Can you hear Erin? I just So if that works, I am good. Thank you. The other two plaintiffs are 22 Barry Briggs and Harold Grogan and they are the two of the 23 Blue Cross/Blue Shield Montana insurance plans who are also 24 patients of Trina in Dillon. 25 The plaintiffs' claims arise from a coverage 10 1 determination made by Blue Cross/Blue Shield Montana, The 2 Montana-based division of Healthcare Services Corporation and 3 referred to in pleadings as BCBSMT and at times by me today 4 as defendant or Blue Cross, your Honor. 5 determination made by Blue Cross was that a treatment had 6 been provided to patient plaintiffs, namely the APT/MII 7 treatment, along with another, who I will refer to as the 8 patient plaintiffs, so Harold Grogan and Barry Briggs are the 9 patient plaintiffs along with another former plaintiff, That coverage 10 Harold Briggs. 11 through April -- Or sorry, from 2015, in the fall of 2015 12 through April of 2017. 13 Blue Cross/Blue Shield Montana. 14 And that treatment was provided from 2017 Through that time, it was covered by It was in April of 2017 that Blue Cross/ 15 Blue Shield of Montana decided that it was no longer covered 16 as a treatment and so Trina Health of Montana LLC, is the 17 entity that the notice was sent to that it was not covered as 18 the only licensed provider of the treatment. 19 plaintiffs were notified of the coverage determination 20 through a cease and desist letter provided to Trina Health of 21 Montana, LLC. 22 providers. 23 Blue Cross/Blue Shield of Montana that will show our 24 inappropriate directives related to coverage today. 25 All the That same one was also sent to employee It contained directive from Included in the directives to Trina Health of 11 1 Montana LLC from Blue Cross/Blue Shield of Montana was the 2 statement that we request that you notify all, notify 3 Blue Cross/Blue Shield members in advance that APT is not 4 covered and they will be fully responsible for the cost of 5 such treatment and that's in Petition Exhibit 4, your Honor, 6 that we will refer to later. 7 cease and desist letter sent to Trina that the coverage 8 determination was made by Blue Cross/Blue Shield of Montana 9 and communicated to all the patient plaintiffs. 10 As such, it is through the The plaintiffs disagree with the coverage 11 determination made in cease and desist letters and the 12 directives contained in cease and desist letters and have 13 caused plaintiff Trina to have to shut its doors because it 14 could not comply with the directive contained in the cease 15 and desist letters and the patients could not afford to pay 16 for the coverage of the treatment. 17 This treatment is the only treatment that is 18 provided by Trina. As described in the petition, plaintiffs 19 provided the information to Blue Cross/Blue Shield of Montana 20 showing that the coverage determination detailed in the cease 21 and desist letters was incorrect. 22 response was to stand by the letters and the coverage 23 determination and deny plaintiffs request to reverse that 24 determination. 25 through 10. Blue Cross/Blue Shield's That dialogue is in Petition Exhibits 7 12 1 As a result, the plaintiffs filed this action 2 seeking the declaratory judgment stated in the petition; 3 namely, that Blue Cross/Blue Shield Montana's determination 4 was incorrect and that the APT treatment is a covered 5 treatment under the plaintiff patient's Blue Cross policies. 6 The plaintiffs are also seeking, your Honor, as 7 you know from this hearing being held today, the injunctive 8 relief that we have requested. 9 Montana's responses to plaintiffs as to why the coverage is Blue Cross/Blue Shield 10 being denied under Blue Cross/Blue Shield of Montana 11 policies, as detailed in the petition and those Exhibits 7 12 through 10 show that the underlying dispute is a coverage 13 dispute over whether or not APT/MII is a medically 14 necessarily treatment or whether it's experimental, 15 investigational or unproven as defined by the terms of the 16 plaintiff patient's plans. 17 There is also a dispute over whether 18 Blue Cross/Blue Shield Montana should be demanding that Trina 19 bill the APT/MII treatment as a different treatment, 20 Outpatient Intravenous Insulin Treatment, your Honor. 21 refer to that as OIVIT and just to cite a little bit of 22 background so you understand what we are referring to, OIVIT 23 treatment is one that Blue Cross found to be experimental, 24 investigational or unproven and they demanded that the 25 APT/MII treatment be billed as OIVIT, even though the I'll 13 1 2 treatment is not substantially similar or the same as OIVIT. So Blue Cross/Blue Shield of Montana, as far as 3 the plaintiffs were concerned, inappropriately related the 4 APT/MII to other treatments not covered by 5 Blue Cross/Blue Shield of Montana in order to make their 6 coverage determination and Blue Cross/Blue Shield of Montana 7 refused to change its coverage determination after being 8 provided with the information detailing that the coverage 9 determination was incorrect. 10 That is when this lawsuit was filed and 11 Blue Cross/Blue Shield of Montana has continued to deny 12 coverage in the answers submitted by Blue Cross/ 13 Blue Shield of Montana in this matter. 14 here today because the preliminary injunction and a temporary 15 restraining order was also something being prayed for in the 16 complaint or the petition as part of the claims, specifically 17 Claim 6 and 7 in the petition. 18 preliminary injunction, that is where we are today. 19 plaintiffs request that this Court enter a preliminary 20 injunction consistent with the temporary restraining order 21 in this matter that does the following: restrains 22 Blue Cross/Blue Shield of Montana from denying coverage for 23 APT/MII treatment provided to patients of Trina Health of 24 Montana who are Blue Cross/Blue Shield Montana insureds and 25 temporarily restrains Blue Cross/Blue Shield Montana from Of course, we are As to the application for The 14 1 demanding that APT be billed as OIVIT under the HCPCS code 2 G9147 and also this Court ordering Blue Cross/Blue Shield 3 of Montana to continue to cover the APT/MII claims submitted 4 by Trina for Blue Cross/Blue Shield Montana patients in the 5 same manner that it covered the treatment prior to 6 determining that APT/MII was excluded from the Blue 7 Cross/Blue Shield of Montana plan as detailed in the cease 8 and desist letters. 9 As the plaintiffs set forth in paragraph 78 of 10 their petition, preliminary injunctive relief may be granted 11 under Section 27.19.201 MCA and section 27.19.314 MCA because 12 the first and fifth claims stated in the petition appear to 13 show that plaintiffs were entitled to the relief granted. 14 The plaintiffs will also provide testimony supporting those 15 claims today, your Honor. 16 claims request the Court to restrain Blue Cross/Blue Shield 17 of Montana in the manner that I just discussed, both for the 18 duration of the rest of this matter until this Court enters a 19 judgment on the petition and to the extent this court 20 determines that the coverage exists beyond that date. 21 The relief in plaintiff's 6 and 7 As further detailed in paragraph 78 of the 22 petition, if Blue Cross/Blue Shield of Montana is allowed to 23 continue to exclude coverage under the patients' plan for 24 APT/MII, Blue Cross/Blue Shield of Montana doing so would 25 produce great and irreparable injury to the plaintiff 15 1 patients and to Trina. 2 And the plaintiff patients and Trina will provide 3 testimony to that today. 4 have a legitimate cause of action and that they are likely to 5 succeed on the merits, along with showing that irreparable 6 injury likely will result to the plaintiffs if the 7 preliminary injunction is not entered by this Court as is 8 required by Montana law. 9 return the status of the plaintiff patients coverage to the 10 last actual peaceable noncontested condition which preceded 11 the pending controversy, that being when they were receiving 12 their covered treatments from Trina for APT/MII paid for by 13 Blue Cross/Blue Shield of Montana on the billings submitted 14 by Trina of Montana and in the manner that Trina believes is 15 accurate for the billing of APT/MII, namely prior to 16 April 12, 2017 and prior to the cease and desist letters sent 17 to Trina of Montana. 18 The plaintiffs will show that they Plaintiffs ask that the Court There is no other adequate remedy in the law in 19 patient plaintiffs' request if the plaintiff's request for 20 injunctive relief is denied and the injunctive relief prayed 21 for will stop the likely irreparable injury from occurring, 22 your Honor. 23 Thank you. 24 THE COURT: 25 Thank you. I am going to ask Ms. Beatty or Mr. Auerbach for an opening if they wish to 16 1 make one but I have one question about what you said at some 2 point during your opening. 3 I understand that you are asking for injunctive relief that 4 would require coverage of people who are not plaintiffs? 5 MS. MacLEAN: This is not a class action so did Yes, your Honor. The reason that 6 the plaintiffs asked me to ask for that is not because that 7 they know of any others that do exist, but these individuals 8 and Trina do not want anybody else to suffer if they are 9 covered by Blue Cross/Blue Shield plans prior to this Court 10 deciding whether or not there is coverage because those 11 Blue Cross/Blue Shield of Montana plans are the same that are 12 issued in Montana. 13 THE COURT: All right. I understand that and I 14 may come back to you on that. I would like to hear what 15 authority there is though for expanding the relief that you 16 are asking for injunctively to people who are not parties so 17 I will let you think about that. 18 MS. MacLEAN: Thank you. 19 THE COURT: 20 MS. BEATTY: 21 If I might, your Honor, I would like to maybe Ms. Beatty. Thank you, your Honor. 22 address that last point first before I get into the remarks I 23 had prepared for today. 24 THE COURT: Hold on one moment. I apologize. 25 Joslyn, if I give you moment, would you be able to 17 1 turn the camera so that Ms. MacLean can see Ms. Beatty? 2 (Off the record.) 3 MS. BEATTY: So taking that last point first and 4 kind of out of order of what I had otherwise prepared to say, 5 your Honor. 6 as such. 7 requesting, the injunctive relief they are requesting 8 attempts to apply to people other than the patient plaintiffs 9 here today, we think that's inappropriate. This is not a class action; it's not been pled To the extent that the relief that they are We don't believe 10 that there is any law or authority that allows such a broad 11 sweeping preliminary injunction or temporary restraining 12 order and that's one of the reasons we have opposed it as 13 long as we have. 14 Also, I don't believe that a class action is going 15 to be appropriate in any event because the relief here is 16 monetary damages. 17 and so I don't think that ultimately at the end of the day, 18 class action is going to be a viable avenue. 19 certainly request the ability to brief that issue should the 20 Court like additional information on that. 21 And so I think, and it's all individual THE COURT: I would And if we get there, I will certainly 22 allow both parties to do that but I just want to make sure I 23 understood what the relief requested was and what the 24 basis was. 25 MS. BEATTY: Absolutely. Thank you. 18 1 I also take issue with several of the facts that 2 Ms. MacLean described in her opening statement. I think the 3 documents in front of the Court with the pleadings will speak 4 for themselves and so I won't go into those details today 5 since this is not a trial on the merits today. 6 here for is the plaintiff's request for a preliminary 7 injunction following the Court's granting of the TRO. 8 just briefly, as this Court has noted already, the plaintiffs 9 have filed three previous motions for temporary restraining What we are And so 10 order, one initially when they initiated the case back in 11 October, the second one was the federal court, the third one 12 when the case was remanded and now this is their fourth one, 13 your Honor. 14 formerly to the briefs to this fourth motion, although I 15 think you can see some of our arguments in our pleadings 16 to date. 17 We have not had an opportunity to respond With this motion, the plaintiffs attempted to fix 18 some of the gaps that we had pointed out in prior responses 19 but we don't believe that they have fixed them all. 20 we believe that the plaintiffs still cannot establish a 21 likelihood of successes on the merits of their claim, nor 22 have they shown that Blue Cross/Blue Shield of Montana's 23 actions were the approximate cause of any alleged injury or 24 that any alleged injury is not otherwise compensable with 25 monetary damages such that an injunctive relief would be In fact, 19 1 appropriate. 2 However, should this Court disagree ultimately, 3 and should the Court enter a preliminary injunction, 4 Blue Cross/Blue Shield of Montana would ask the Court to 5 adhere to the statutory requirements that would require the 6 plaintiffs to post a bond and adequate surety for this case 7 going forward to the extent we have to pay for treatment 8 pending the ultimate resolution of the case and that the 9 Court appropriately limit the injunctive relief to the 10 parties in this case and not issue the broad, overly-broad 11 injunctive relief that the plaintiffs have requested. 12 The plaintiffs' request for preliminary injunction 13 seeks, in our opinion, seeks this Court to predetermine the 14 matters to the case and reverse in course not only for 15 Blue Cross/Blue Shield but for several other insurers around 16 the country, as well as Medicare. 17 treatment, using Trina Health's trademarked method of insulin 18 infusion known as APT, APT is Artificial Pancreas Treatment, 19 and that phraseology has been trademarked by Trina Health. In refusing to cover 20 To be clear the bar for preliminary injunction, 21 however, the plaintiff must first demonstrate that they are 22 likely to succeed on the merits of their claim. 23 simply lack any credible evidence to establish or meet their 24 burden. 25 caused by Blue Cross/Blue Shield Montana but instead they are Here they Secondly, the plaintiffs' alleged injuries were not 20 1 caused either by Trina's own decisions to close its doors 2 rather than charge patients for its services or bill using 3 appropriate codes. 4 treatment options available to them by either seeking APT 5 treatment from other providers other than Trina or by seeking 6 standard diabetes treatment other than APT. 7 And the plaintiffs still had other Third, this is not an appropriate case for 8 declaratory relief or preliminary injunction because of the 9 extensive factual inquiry that's necessary to ultimately 10 decide the issues and because the plaintiffs' alleged 11 injuries can be adequately remedied with monetary damages. 12 Trina claims, Trina's claims for payment submitted to 13 Blue Cross/Blue Shield of Montana for APT were determined to 14 be experimental, investigational or unproven as APT treatment 15 is substantially similar to other insulin infusion treatments 16 expressly excluded from coverage under Blue Cross/Blue Shield 17 of Montana's medical policies. 18 infusion treatments have been developed and modified as far 19 back as the 1970's. 20 universally been dismissed as generally-accepted standard of 21 treatment for diabetes because scientific evidence has not 22 yet supported their application. 23 different. 24 similar to the other treatments that have been found to be 25 not clinically necessary or not yet moved into the category For many years, insulin However, these treatments have Trina's APT process is no It is yet another form of insuline infusions 21 1 of proven rather than unproven treatments. 2 THE COURT: And I apologize for interrupting you 3 but it appears that there were one or two articles attached 4 to some of the pleadings filed by the plaintiffs. 5 saying that those are not peer-reviewed or that the contents 6 of those articles, which I have looked at but I have not 7 memorized, suggest that the treatments are not generally 8 accepted? 9 MS. BEATTY: Yes, your Honor, both. Are you And we have 10 Dr. Pujol here today who can speak to those articles and 11 speak to generally the process of getting a treatment, a 12 medical procedure to be moved out of the category of 13 experimental or unproven and into the category of standard of 14 care, medically necessary, scientifically-proven. 15 opinion that Dr. Pujol's testimony will show that the 16 materials provided by Trina to this Court with its petition 17 are either Trina's own marketing materials created by Trina's 18 own providers and staff members or they are observational 19 studies that don't rise to the same level of a scientifically 20 randomized study with control groups that one would typically 21 rely upon to move the treatment into that proven category 22 instead of the experimental and unproven category. 23 THE COURT: 24 MS. BEATTY: 25 Its our Thank you. In fact, as recently as 2015, Trina's own doctors or own providers described APT as another 22 1 infusion treatment similar to PIVIT, which Ms. MacLean talked 2 about before, which is Pulsatile Intravenous Insulin Infusion 3 Therapy and CIIIT, which is Continuous Insulin Infusion 4 Therapy. 5 treatments by their acronyms rather than the mouthful that 6 they are. For today, I am going to continue to refer to those 7 At most though, Trina's claims of, Trina claims 8 that APT is an attempted improvement on existing infusion 9 therapies. Neither APT, PIVIT nor CIIIT are accepted as 10 standard of care. In fact, even CMS, which administers the 11 Medicare program expressly found in 2009 that infusion lacked 12 sufficient scientific evidence to allow for coverage. 13 position has not changed, to the best of our knowledge. 14 Those documents are also attached to the letters that Ms. 15 MacLean referenced that are attached to her petition so those 16 documents are already before the Court in the record. 17 thrust of the plaintiff's claims then are that 18 Blue Cross/Blue Shield Montana erred when it sent the cease 19 and desist letters to Trina and its employed providers 20 directing them to bill for the provisions of APT services 21 using the CIIIT or the PIVIT codes, which would place APT in 22 the category of experimental-unproven-investigational. 23 issue of the use of the proper coding procedures by Trina 24 falls squarely within the participating provider agreement 25 between Trina, it's employee providers and Blue Cross/ CMS's The The 23 1 Blue Shield Montana. 2 that agreement controls the ultimate resolution of that issue 3 and any dispute between Blue Cross/Blue Shield Montana and 4 Trina on that matter. 5 arbitration pursuant to the language of that agreement. 6 As such, the arbitration provision in THE COURT: Those claims must be submitted to What about the plaintiff's point that 7 the plaintiffs, the individual plaintiffs are not party to 8 that agreement? 9 MS. BEATTY: So they are not party to that 10 agreement, your Honor, but the coding and the processing and 11 the determination of what is a covered service and not a 12 covered service, those are all squarely within that 13 agreement, and there is an obligation on Trina as the 14 provider to bill appropriately pursuant to medical policies 15 and procedures established by Blue Cross/Blue Shield Montana, 16 including that it cannot bill for noncovered services. 17 the concept of determination of whether that service is 18 covered or not covered is it does fall within the 19 participating provider agreement and we believe is subject to 20 the arbitration proceedings. 21 THE COURT: 22 MS. BEATTY: So All right. We did file the Motion to Compel 23 Arbitration, your Honor, and those issues are briefed in 24 those pleadings. 25 THE COURT: I saw that. 24 1 MS. BEATTY: So it's our, it's our position that 2 this Court today shouldn't and cannot resolve those issues. 3 Those issues should be taken up by an arbitrator in an 4 arbitration proceeding. 5 THE COURT: 6 MS. BEATTY: 7 procedural process that Trina uses. 8 THE COURT: 9 MS. BEATTY: "Those" meaning coverage? Yes, coverage and coding and the All right. However, even if this Court considers 10 the question of whether APT is a covered service or whether 11 it's excluded as experimental or unproven, the plaintiffs, we 12 believe, are unlikely to succeed on the merits. 13 here today and can testify to the process that Blue Cross/ 14 Blue Shield Montana uses to develop its medical policies. 15 The process it uses to determine what services are covered 16 and what are not medically necessary for treatment, the 17 rigorous review that any medical treatment must be subjected 18 to before it can be classified as medically necessary or 19 meeting the standard of care whether APT is listed in 20 Blue Cross/Blue Shield of Montana's medical policies, whether 21 it's substantially similar to other treatments specifically 22 listed in those policies. 23 THE COURT: Dr. Pujol is Is he going to also be addressing the 24 2015 to April 2017 coverage that occurred before the cease 25 and desist letter? 25 1 MS. BEATTY: Your Honor, that's a good question. 2 At a break at some point, I will ask him whether he is 3 competent to testify to that or if he is not. 4 5 THE COURT: Okay. And I see that he is nodding when I asked that question. 6 MS. BEATTY: Okay. I have our other witness here 7 today. 8 Smith may also be able to answer those questions. 9 10 I wasn't sure if she was needed or not but Jamie I will say though, your Honor, I would direct you back to the cease and desist letters themselves -- 11 THE COURT: 12 MS. BEATTY: Which I have read. -- from April and they reference that 13 Blue Cross/Blue Shield conducted a routine ordinary audit and 14 determined that these things were not being coded correctly 15 and that's what started this process. 16 THE COURT: All right. Dr. Pujol will also 17 testify about whether APT treatment or the treatment that's 18 substantially similar to is properly classified as 19 experimental or unproven or whether they should be classified 20 as meeting the standard of care, which we suggest they are 21 not. 22 hearing on the merits and does not preclude future discovery, 23 fact or expert testimony or at trial, the plaintiffs do have 24 the burden of showing that they have a likelihood of success 25 on the merits, which we don't believe that they can do While a preliminary injunction hearing is not a full 26 1 2 here today. The second point, your Honor, is that the 3 plaintiffs alleged injuries. We don't believe that they were 4 caused by Blue Cross/Blue Shield of Montana. 5 presented affidavit testimony describing their health 6 conditions and proposed future medical treatment plans, and 7 they have suggested that their medical conditions may be 8 deteriorating. 9 Blue Cross/Blue Shield Montana has taken any steps to prevent While they have They have presented no evidence that 10 them from seeking the treatment that they want or need and 11 that they and their providers have decided that they want or 12 need or should have, including APT treatment from either 13 Trina or from any other provider of APT treatment; nor have 14 they presented any evidence that Blue Cross/Blue Shield took 15 any steps to prevent Trina or any other provider from 16 rendering treatments to the plaintiff patients; nor have they 17 presented any evidence that Blue Cross/Blue Shield precluded 18 them from seeking any other diabetes treatment that does meet 19 the standard of care or is considered a covered service. 20 As Dr. Pujol will testify, the only action 21 Blue Cross/Blue Cross Montana took was to direct Trina Health 22 and its employed providers to use the proper billing codes 23 when submitting claims for services. 24 that its providers are required by their agreements to bill 25 bundled services under appropriate bundled code and not to Dr. Pujol will testify 27 1 unbundle the services into various component parts and that 2 the billing codes themselves are defined and created by 3 separate interdependent agencies and not by 4 Blue Cross/Blue Shield of Montana. 5 letters did not direct Trina to close its doors or to cease 6 its practice. 7 nor do those letters or any other action by 8 Blue Cross/Blue Shield of Montana direct the plaintiffs to 9 stop or to not get any other diabetes treatment. The cease and desist It didn't direct them to cease providing APT 10 Blue Cross/Blue Shield has not revoked any coverage of any 11 benefits that were previously covered under the patient 12 benefit plans. 13 services to its members and Blue Cross/Blue Shield Montana 14 recognizes that any treatment decisions take place between 15 the member and his or her physician. 16 They have never denied provision of APT Blue Cross does, however, administer benefits 17 according to the members' plans and its medical policies and 18 Blue Cross's policy that treatment or care that is needed 19 should not be delayed or refused based upon a coverage 20 determination. 21 Cross/Blue Shield is required to pay for services that are 22 not otherwise covered under its plans. 23 That does not mean, however, that Blue THE COURT: 24 not ERISA plans? 25 ERISA plans? There is no question that these are That was too many negatives but are they 28 1 MS. BEATTY: To my knowledge at this point in the 2 litigation, your Honor, I don't believe that the remaining 3 plaintiffs are ERISA plans. 4 plan, but his claims were dismissed voluntarily in the 5 federal court proceedings. 6 7 THE COURT: And if I could just Ms. MacLean, you do agree that these are not ERISA plans? 10 11 Thank you. interrupt for one moment. 8 9 Ron Briggs did have an ERISA MS. MacLEAN: Yes, we agree, your Honor, that they are not ERISA plans. 12 THE COURT: 13 MS. BEATTY: All right. Thank you. Further, even a denial of medical 14 benefits is not necessarily irreparable harm. 15 have indeed found that the loss of certain medical benefits 16 where other benefits are still available does not constitute 17 irreparable harm. 18 you or I can brief that for you should you want those cites, 19 your Honor. 20 21 22 Other courts I have some case cites that I can provide THE COURT: Do you have those cites in front of you? MS. BEATTY: I do. So the Fifth Circuit is one 23 case in Nichols versus Alcatel, A-L-C-A-T-E-L, USA and that's 24 at 532 F3d 364; Cooper versus TWA Airlines, which is an 25 Eastern District of New York decision, 274, F.Supp. 2d 231; 29 1 and then International Longshore & Warehouse Union Local 142 2 versus C. Brewer and Company and that's a, looks like a 3 Hawaii decision, your Honor, found at 2006 Westlaw 1994, 535 4 and that was in 2006. 5 So even if APT was not a covered service, your 6 Honor, the patient plaintiffs were able to seek treatment for 7 diabetes with conventional recognized standard of care 8 services and so they have benefits available to them that 9 would have been covered. 10 Third, an injunctive relief is not appropriate 11 because of the essential factual inquiry necessary here, your 12 Honor. 13 a substitute for other regular actions. 14 decision from the Montana Supreme Court. A declaratory judgment was never intended to provide 15 THE COURT: At least that's a But I think, for instance, I think in 16 Jacobson, the Court granted a preliminary injunction; as 17 I recall. 18 MS. BEATTY: Yes and there have also been other 19 cases. 20 have been cases where injunctions are not granted when the 21 plaintiffs have other services available to them so I think 22 it's a, the point I am trying to make is it's a fact-by-fact 23 pretty intensive factual determination. 24 25 I'd have to dig it out of my notes, your Honor, there THE COURT: I had thought the point you were making was a dec action that injunctive relief was never 30 1 appropriate. 2 MS. BEATTY: Um, yes, that is, I guess that is one 3 of the points I am trying to make, your Honor, is that when 4 you have a fact-intensive inquiry, you know, pause should be 5 given to dec actions and injunctive relief. 6 THE COURT: 7 MS. BEATTY: Okay, understood. Okay. The last -- I'll move forward, 8 your Honor. The last point I'd like to make is the 9 plaintiffs alleged injuries, if they have injuries that are 10 compensable here, they can be adequately remedied with money 11 damages and that makes injunctive relief inappropriate, as 12 well. 13 any actions to prevent them from seeking treatment, including 14 APT. 15 services. 16 pending the resolution of this case. 17 determined that Blue Cross/Blue Shield of Montana must cover 18 them, we can pay for them because, because they have the 19 ability to go get those services. 20 for it out-of-pocket, they can be reimbursed for any damages 21 as a result of that at the end with a payment. 22 As noted, Blue Cross/Blue Shield Montana did not take So they could and can still, I suppose, secure those They would have to pay out-of-pocket for them THE COURT: If it's ultimately Even if they have to pay And I know this will likely be 23 addressed during the hearing but I don't know anything about 24 the cost really about any of these services or about the 25 assets of these plaintiffs have so if, while academically 31 1 that may be true, what if they simply can't, don't have the 2 money in their pockets to pay out of? 3 MS. BEATTY: Yeah, that's a fair question, your 4 Honor. And I don't have a great answer to that because I 5 don't have information about their personal financial 6 information and I am not sure whether that's going to be 7 presented here today or not. 8 assets they own that they can pledge as collateral for loans. 9 I don't know what other resources they have. I don't know what kind of I don't know 10 what kind of family member support they might have. 11 know what kind of financial support Trina itself at the 12 national level or the local level might be able to provide. 13 But I don't think that that's the relevant portion of 14 inquiry. 15 damages and I think that it can. 16 I don't The inquiry is can it be compensated with money THE COURT: All right. I understand what you are 17 saying and I am trying -- I am going to be challenging both 18 of you because frankly, I am trying to think through this and 19 understand what the brackets are, so thank you. 20 MS. BEATTY: 21 THE COURT: Thank you. So Ms. MacLean, and I will tell you 22 both this, everyone has acknowledged this is a preliminary 23 injunction hearing. 24 am just asking everyone to recognize that if we go further, 25 there will be more facts to be discerned so I am asking you I have blocked out the afternoon but I 32 1 to focus on the inquiry that is necessary for me to make this 2 decision today and narrow your inquiry with your witnesses to 3 fit that please. 4 5 All right. And so you may begin. me okay? 6 MS. MacLEAN: 7 THE COURT: 8 MS. MacLEAN: 9 Are you hearing Yes. Thank you, your Honor. Okay. The plaintiffs call Julie Briggs to the stand. 10 THE COURT: All right. Ms. Briggs, I think is 11 your clerk, Ms. Anderson, or a clerk there with you in Dillon 12 or should we swear you in? 13 MS. MacLEAN: 14 THE COURT: 15 16 right hand. There is. All right. So if you will raise your Thank you. I will just remind everybody. I know Ms. MacLean 17 knows this but Ms. Briggs, please take turns so that we can 18 hear you and if you hear me start talking, I am probably 19 stopping you so because someone can't hear you. 20 THE WITNESS: 21 THE COURT: Okay? Yes, ma'am. Thanks. 22 23 JULIE BRIGGS, 24 called as a witness, and having been first duly sworn, was 25 examined and testified as follows: 33 1 DIRECT EXAMINATION 2 BY MS. MacLEAN: 3 Q. Please state your name for the record. 4 A. My name is Julie Briggs. 5 Q. And where do you reside? 6 A. I reside in Dillon, Montana. 7 Q. And how are you related to Trina of Montana in 8 this case? 9 A. I am the administrator. 10 Q. Are you also related to Trina in another manner? 11 A. My late husband owns the clinic and I am operating 12 13 14 it under his estate. Q. So you are the person operating the clinic under his estate? 15 A. Yes. 16 Q. What was his name? 17 A. Harold Laron Briggs. 18 Q. So were you part of the clinic when it opened 19 initially? 20 A. Yes, I was. 21 Q. Will you please explain what brought about the 22 23 opening of the clinic? A. My husband had diabetes for probably about 24 53 years, and at the point in time when he was starting to 25 have some major problems with his diabetes, and I went to the 34 1 doctor with him every time he went to the doctor and the 2 conventional treatments were not working, or the treatments 3 that the doctor wanted to provide for him. 4 he went to the doctor, she told him that she wanted to put him 5 on pain pills and anti-depressants. 6 funeral directors in town and I know what pain pills and 7 anti-depressants mean and I wasn't ready to lose my husband. 8 9 10 11 12 13 Q. you are a diabetic? A. It means they are trying to put you on comfort care because they don't know what else to do for you. Q. What do they think is going to happen next to you? THE COURT REPORTER: 15 THE COURT: 16 THE COURT REPORTER: 18 And we are the local What do pain pills and anti-depressants mean when 14 17 And the last time I need that question again. Hold on, hold on. I'm having a hard time hearing them. THE COURT: We are having a hard time hearing so 19 I know it's the mic system, but Ms. MacLean, when you ask 20 your questions, take your time, make sure you are right by 21 the mic please. 22 23 MR. AUERBACH: Your Honor, I'm going to interject an objection in terms of foundation and hearsay. 24 THE COURT: Hold tight. 25 MR. AUERBACH: I just wanted to interject an 35 1 objection on the grounds of hearsay, as well as foundation in 2 terms of medical testimony. 3 THE COURT: Sustained. 4 Ms. MacLean, I am going to ask you to ask the 5 witness for personal knowledge. If you are asking what 6 doctors said, we will have to get that in another way. 7 8 BY MS. MacLEAN: 9 Q. Before you went to Trina for the first time or 10 before your husband Ron went to Trina for the first time, 11 what did you believe was going to happen if he didn't receive 12 a different treatment than what doctors were providing him? 13 14 A. I went to the doctor with my husband and the doctor told me -- 15 16 I believed that he was going to die. THE COURT: Hang on, hold on, hold on. That's hearsay. 17 THE WITNESS: Okay. I just believed that he was 18 going to die because they wanted to give him pain pills and 19 anti-depressants. 20 21 BY MS. MacLEAN: 22 Q. 23 24 25 And so what, in your experience as a funeral director, how does that bring about your understanding? A. Because they don't have anything else to do for you and so you are at end of life. And my husband was turning 36 1 gray, he was getting very, very weak and very tired, he 2 couldn't function, he could not work. 3 at the funeral home and I was doing all the work. I was carrying the load 4 Q. And what year was this? 5 A. This was 2014. 6 Q. So what did you do? 7 A. So I decided that I was going to find something 8 that would help him because there was evidently nothing that 9 anybody could do medically that could help him so -- 10 Q. Are you talking about here in Dillon? 11 A. Yes. And so I decided that I was going to look 12 for artificial pancreases because I heard that they were 13 doing that in Germany and other countries. 14 to take him to get artificial pancreas. 15 online and I saw Artificial Pancreas Therapy and I -- in the 16 United States and so I called the number -- 17 18 Q. And so I wanted And so I looked up Did you locate a Trina -- Is that what you located was a Trina? 19 A. Yes. 20 Q. Is that Trina Health, LLC in California? 21 A. Yes, that's the number I called. 22 Q. Okay. 23 A. They gave me some information on what the 24 treatment was and it sounded logical to my nonmedical mind and 25 so I made my husband promise that he would at least try it for 37 1 two months. And when he first start -- 2 Q. Tell us what you did next. Where did you go? 3 A. I set up an appointment for Arizona because -- 4 Q. What clinic? 5 A. With Trina Health of Scottsdale, Scottsdale, 6 Arizona and my husband was not capable of going down for 7 treatments himself. 8 of figuring out where he needed to go to get, for his 9 treatments. He was not physically or mentally capable And so I hired someone for three weeks and I went 10 with my husband down to Scottsdale, Arizona because we had 11 formerly been from Arizona and I figured that I could help him 12 figure out the logistics and so I took him down to Arizona 13 the first time and he had two treatments in a row. And he 14 thought he felt better but he didn't really know. And then 15 the second week, we went down, he thought he felt a little 16 better and the third week, he ran across the street and he 17 hadn't run in probably a year and we both looked at each other 18 and we started laughing. 19 Arizona by himself and he called me up and he said, "I don't 20 know what we are going to do but I need to have this treatment 21 the rest of our, my life". 22 figure it out". 23 home and move to Arizona and start a business down there but 24 that didn't work and so I started on a venture to try to get a 25 Trina Health here in Dillon, Montana. And the fourth week, he went down to And I said, "Well, honey, we will And so we thought we would sell the funeral And I knew of other 38 1 people that were ill that had diabetes that I felt the 2 treatment would help. 3 4 Q. Were two of those people the witnesses and the plaintiff patients sitting in the courtroom today? 5 A. Yes, they are; Barry Briggs and Harold Grogan. 6 And I was very concerned about one of them and the other one, 7 I am very concerned about now as well since I got to know him 8 better. 9 husband's life at that time. But I do believe that the treatment saved my And he had gastroparesis and 10 that was something that was resolved with treatment. 11 he was able to mentally function. 12 the treatment. 13 Q. 14 help him? 15 A. He had, His mind was clearer with Had any other treatment done anything else to No. And he also had three major surgeries while 16 he was seeking the treatment. 17 reconstruction that was a six-and-a-half hour surgery and 18 normally, diabetics don't heal that well. 19 treatment, the doctors said that he healed remarkably well and 20 that, that surgery he had about, it was in March of not last 21 year but the year before, and he was totally healed from that 22 and he had two shoulder surgeries the year before. 23 Q. He had a total hip But with the Let's go back to when you were in Arizona and you 24 were thinking about opening this up. 25 wanted to open it up here in Dillon? So did Ron tell you he 39 1 A. Yes, he did. 2 Q. Did you work towards doing that? 3 A. Yes. 4 Q. And when you were traveling to Arizona, who, what 5 payor was covering Ron's treatments? 6 A. Blue Cross and Blue Shield of Montana. 7 Q. Was it your understanding at the time that 8 Blue Cross/Blue Shield of Montana covered that treatment? 9 A. Yes, it was. 10 Q. And did they ever deny those treatments when you 11 went to Arizona? 12 A. No. 13 Q. And so you came here and you opened up this 14 clinic. When did you open this clinic as administrator 15 helping your husband as the owner? 16 A. It was October of 2015. 17 Q. And is that when you started treating the two 18 plaintiff patients? 19 A. Yes. 20 Q. And what was their coverage at the time for 21 22 health insurance? A. Blue Cross/Blue Shield of Montana. In fact, one 23 of them changed to Blue Cross/Blue Shield of Montana because 24 he had a different insurance and Blue Cross/Blue Shield paid 25 several treatments. 40 1 Q. They covered the treatment? 2 A. Yes. 3 Q. Do you remember executing two affidavits for the 4 Court in support of the temporary restraining orders filed in 5 this matter? 6 A. 7 8 Yes, I do. MS. MacLEAN: Your Honor, I am going to put those in front of her, if that's okay with you. 9 THE COURT: Sure. 10 11 BY MS. MacLEAN: 12 Q. Do you recognize these affidavits? 13 A. Yes, I do. 14 THE COURT: And just for the record, I believe you 15 have, this is a document from the court docket, 16 Document No. 5 -- I am having a little trouble reading these 17 and I am assuming perhaps Document 6 -- I am just, I just 18 want to make a record of which ones you are showing her. 19 MS. MacLEAN: 20 of the documents. 21 the titles. 22 Your Honor, I don't have the numbers Those were not provided to me. THE COURT: All right. I will use Thank you. 23 24 BY MS. MacLEAN: 25 Q. The title of the first one that was filed 41 1 October 23, 2017 is the affidavit of Julie Briggs on behalf 2 of plaintiff Trina Health of Montana, LLC. 3 affidavit filed January 23, 2018 and it's called the 4 supplemental affidavit of Julie Briggs on behalf of plaintiff 5 Trina Health Montana, LLC. 6 THE COURT: The second is the Thank you. 7 8 BY MS. MacLEAN: 9 Q. 10 Let's take a look at the affidavit of Julie Briggs filed on October 23 first. Do you see that? 11 A. Yes. 12 Q. You can take a look at that. 13 Is everything in this affidavit still true? 14 A. Yes, it is. 15 Q. And so let's take a look at the part where it 16 talks about you receiving the cease and desist letters. But 17 before that, I want to ask you; at any point between when you 18 opened the clinic in 2015 to the point where you received the 19 cease and desist letters in 2017, was there any indication 20 that Blue Cross/Blue Shield of Montana thought this was an 21 experimental, investigation or unproven treatment? 22 A. No. 23 Q. And so what happened in April of 2017 that made 24 25 you understand that this had changed? A. I have had a cease and desist letter. 42 1 Q. And is that cease and desist letter the same 2 cease and desist letter sent to Harold Laron Briggs on 3 April 12, 2017? 4 Ms. MacLEAN: That were attached to Petition 5 Exhibit 4, your Honor so it's attached to the Petition 6 Exhibit 4, starting at Page No. 368 of the Bates numbering. 7 THE COURT: Thank you. I have that here. 8 9 10 BY MS. MacLEAN: Q. There are a number of cease and desist letters 11 there and this is the one that's sent to Harold Laron Briggs. 12 Did you receive this as the administrator? 13 hand that to you. I am going to 14 A. Yes, I did. 15 Q. What was your reaction when you received this 16 17 letter? A. Well, I contacted the billing department at the 18 corporate office because they are the ones that handle the 19 billing. 20 Q. What was the corporate office? 21 A. Trina Health in Sacramento. 22 Q. Trina Health, LLC in Sacramento, California? 23 A. Yes. 24 Q. They handle the billing for 25 Trina Health Montana, LLC? 43 1 A. Yes, that's correct. 2 Q. And you contacted the billing department there 3 4 and what did they say to you? A. Um, that we couldn't bill because we had a cease 5 and desist letter and so basically, I couldn't treat the 6 patients and I couldn't keep the doors open because if I 7 couldn't bill for the treatment, then I couldn't provide the 8 treatment to the patients. 9 Q. And so with this understanding, that is -- 10 A. I was confused because I felt that the treatment 11 had been covered before and they wanted me to bill under 12 something that the treatment isn't. 13 Q. So they were trying to -- and just to look on 14 Page 2, are you saying that they were trying to cause you to 15 bill under the HCPCS code 09147, that is OIVIT? 16 A. Right. 17 Q. And you are saying that is not the treatment? 18 A. Right. 19 Q. And so you didn't feel you could do what it is 20 21 Blue Cross/Blue Shield told you to do in this letter? A. That's correct. I was told that if I billed under 22 OIVIT, then that would be fraud because it's not the same 23 treatment. 24 25 Q. So you were basically put in a position by this demand letter from Blue Cross/Blue Shield Montana where it 44 1 paralyzed your ability to move forward? 2 A. Correct. 3 Q. Blue Cross/Blue Shield Montana is claiming they 4 had no part in your closing. 5 statement said. 6 A. That's what the opening Do you disagree with that? I totally disagree with that. I believe that if 7 they had been, if they would pay the claims, then I could 8 provide the treatments for the patients. 9 10 Q. And those claims had to do with coverage, not anything to do with the provider agreement, correct? 11 A. Correct. 12 Q. It has to do with the patient's policies? 13 A. Correct. I know my husband's policy covered -- 14 MR. AUERBACH: 15 THE COURT: 16 Objection, your Honor. One moment. Hold tight. I know we have a little delay but there is an objection. 17 MR. AUERBACH: Sorry, your Honor. I was just 18 going to object on the basis of foundation as well as 19 mischaracterization of documents that have not been presented 20 as evidence. 21 THE COURT: Sustained. I think you are reaching a 22 little bit on the evidentiary basis so I am going to sustain 23 that. 24 25 45 1 BY MS. MacLEAN: 2 Q. Will you take a look at where it starts on the 3 second page, the 2017 HCPCS Level II Manual. Do you see that 4 paragraph? 5 see that? 6 A. Oh, yes. 7 Q. Did you read it? 8 A. Yes. 9 Q. Is there any place in this paragraph that refers It's the second paragraph after the box; do you I'm sorry. 10 to the artificial pancreas treatment that you were providing 11 at the time? 12 A. 13 No. It refers to OIVIT. THE COURT: I'm sorry. I didn't hear that. 14 15 BY MS. MacLEAN: 16 Q. It refers to OIVIT; is that what you are saying? 17 A. Correct. 18 Q. Can you take a look at the next paragraph. It 19 refers you to the same medical policy that is attached to 20 this letter. Do you remember that medical policy? 21 THE COURT REPORTER: 22 THE COURT: 23 I think she did, ma'am? 24 MS. MacLEAN: 25 policy in front of her. Did she say "no"? Did you say, "no"? She doesn't, she doesn't have the 46 1 THE WITNESS: 2 THE COURT: 3 5 I just, we are just trying to get an accurate transcription. 4 In front of me. Did you say, "no" initially. THE WITNESS: Yes, I said, "No, I don't have the policy in front of me". 6 THE COURT: All right. 7 8 BY MS. MacLEAN: 9 Q. 10 Do you now have the policy in front of you that were attached to that letter? 11 A. Yes. 12 Q. And the policy is titled -- What is the policy? 13 A. Chronic Intermittent Intravenous Insulin Therapy. 14 THE COURT: I'm sorry. Hang on. I did not 15 understand that and I am sure the court reporter didn't. 16 you read it clearly and slowly. 17 18 THE WITNESS: Can Chronic Intermittent Intravenous Insulin Therapy. 19 THE COURT: Thank you. 20 21 BY MS. MacLEAN: 22 Q. 23 Medical policy 201.208, is that correct? Is that what you see is the medical policy number? 24 A. Yes. 25 Q. Is there any -- Would you read this policy. 47 1 Was there anything in this policy that referred to the 2 APT/MII Treatment that you were providing at Trina? 3 A. No. 4 Q. So you said in Paragraph 6 of your affidavit, can 5 you see that? "The cease and desist letter did not make 6 sense to me in light of the fact that I was trying to force 7 Trina to bill for APT/MII under a code that was not 8 applicable to APT/MII? 9 A. Correct, yes. 10 Q. And what code is that that they were trying to 11 make you bill under? 12 A. I'm sorry. 13 Q. What code were you talking about in -- 14 A. OIVIT code. 15 Q. And what number is that code? 16 A. It's G9147. 17 Q. And so what did you do after you spoke to 18 Trina Health, LLC, and learned that this put you in a place 19 where you couldn't bill for this treatment? 20 A. I had to close the doors. 21 Q. Why is that? 22 A. Because Blue Cross wanted me to bill for something 23 that we weren't doing and it wasn't allowing me to bill for 24 something that we were doing. 25 because it's my understanding if a patient has insurance, then And I was at a conundrum 48 1 you have to accept the insurance and you can't make them pay 2 out of pocket if they have insurance and so that's why we are 3 here. 4 5 Q. And if the patients couldn't pay out of pocket even if you could bill them, could you stay open? 6 7 MR. AUERBACH: Objection. Calls for speculation, your Honor. 8 THE COURT: Sustained. 9 10 BY MS. MacLEAN: 11 Q. 12 Were there any circumstances under which under you could stay open at this time? 13 A. No. 14 Q. This was a result of receiving this letter from 15 Blue Cross? 16 THE COURT: Ms. MacLean, I didn't hear your 17 sentence. It was just a little fast and I am trying to 18 protect the court reporter who is trying to get this down so 19 could you repeat that? 20 21 BY MS. MacLEAN: 22 Q. 23 24 25 And this was a result of you receiving this letter from Blue Cross? A. That's correct. THE COURT: Thanks. 49 1 BY MS. MacLEAN: 2 3 Q. So what happened after you had to close the clinic with Ron's health? 4 A. Ron's health declined. He was getting very weak 5 (crying) and he had told me that with this treatment, he was 6 going to live to be 75. 7 Q. How old was he this year? 8 A. Sixty-one. And he really wasn't doing very well 9 and we thought that it was because he was slowing down because 10 of his diabetes and when he was on the treatment, he was doing 11 great. 12 13 Q. And did this decline happen after you had to discontinue treatment and close the doors of the clinic? 14 A. Yes. And so he was starting to feel really weak 15 and tired and I thought that he had the flu or something 16 because the flu was going around. 17 Q. Was this in December? 18 A. This was in December. 19 Q. Of 2017? 20 A. Of 2017. And he just was really, really tired and 21 I kept thinking well, maybe we are going to get the clinic 22 opened and he will be able to start getting those treatments 23 and things will get better because we really couldn't afford 24 for him to be traveling or he wasn't feeling well enough to 25 travel. And so right before Christmas, he said, "I don't 50 1 think I am going to make it through the night," and so I said, 2 "Well, we better go to the hospital then." 3 the hospital and they transported him to Butte because the 4 flights were down and he, they wanted to do a heart 5 catheterization and they said that his creatinine was a little 6 bit high and they wanted to bring that down because of his 7 diabetes, it was a little bit high. 8 9 Q. So I took him to Let's go, let's talk a little bit about is it your understanding that the diabetes created the 10 complications that he was having that was causing him to go 11 downhill? 12 A. Yes. 13 Q. And did that continue on for the rest of the 15 A. Yes. 16 Q. And how many days after he went to Butte did he 14 17 week? spend in the hospital? 18 A. 19 what, five days. 20 Q. 21 He was, um, Saturday, Sunday, Monday, Tuesday, This was from the 22nd of December until the 27th of December? 22 A. Yes. 23 Q. And did he eventually go into a coma? 24 A. Yes. 25 He had a heart attack in Butte on Christmas Eve morning and he was life-flighted to Billings 51 1 and then they were supposed to do open heart surgery. 2 think he would have made it through the surgery with the, with 3 the treatment. 4 know he has made it through many different things and he was 5 a fighter but it was Christmas and I don't exactly know what 6 all was going on there but I don't know if his diabetes was 7 too bad but he, his kidneys shut down and he had a blood clot 8 and -- 9 10 Q. And I I think he probably -- Well, I don't think. I So I want to talk about your affidavit that you did back in October of 2017 on the 23rd, paragraph 11 says -- 11 A. I'm sorry. Where is that? 12 Q. In your Affidavit, paragraph 11 on Page 3, do you 13 see where it says, "I am afraid Ron is going to die prior to 14 the resolution of this dispute"? 15 A. Yes, I do. 16 Q. Is this the irreparable injury that you were 17 afraid of when you first filed the temporary restraining 18 order in this court? 19 20 MR. AUERBACH: Objection, your Honor. legal conclusion. 21 THE WITNESS: 22 THE COURT: 23 THE COURT REPORTER: 24 25 This is a (Inaudible.) Overruled. Hold on. I didn't get any of that answer. THE COURT: Hold tight, hold tight. We didn't get 52 1 the answer and I know there's a little bit of a delay but 2 there is an objection. 3 What was the objection? 4 MR. AUERBACH: 5 THE COURT: It was a legal conclusion. Calling for a legal conclusion. I 6 overruled that but in the meantime, I did not hear the answer 7 so if you could get that repeated. I'm sorry. 8 9 10 11 12 BY MS. MacLEAN: Q. Is this what you were afraid of as far as irreparable injury that you were concerned about? A. Yes because the treatments helped Ron before and I 13 could see that he was going downhill and I was worried about 14 not only Ron but I was worried about our other patients here 15 because they have health issues as well. 16 Q. Can money damages ever bring Ron back? 17 A. No. 18 Q. Blue Cross/Blue Shield of Montana claimed that 19 irreparable injury could be fixed by monetary damages. 20 you agree with that? Do 21 A. No (crying). 22 Q. Can you open, if were you to reopen Trina, unless 23 you have a court order ordering Blue Cross/Blue Shield to pay 24 for the treatment of these patients would you be able to 25 reopen for? 53 1 A. No, I can't. 2 Q. If you have a court order in place, would you be 3 willing to open up in order to treat these patients? 4 A. Yes, I do believe I would. 5 Q. Do you know of any other Blue Cross/Blue Shield 6 of Montana patients other than those patients that are also 7 plaintiffs in this matter who want to treat at your clinic? 8 9 10 A. Yes, I do. I have a couple that has called expressing interest in being treated and one that would travel from the other side of the state to be treated. 11 Q. At this time though, were they treating prior to 13 A. No. 14 Q. And by, "a couple", how many is that? 15 A. Two. 16 Q. So did you understand last Friday that a TRO, a 12 April? 17 temporary restraining order was issued by this Court that 18 would allow, would cause Blue Cross/Blue Shield to pay for 19 the treatment of these patients essentially pending the 20 outcome of this hearing today? 21 A. Yes. 22 Q. Did you, in fact, open to treat the patients? 23 A. Yes. 24 25 We treated Harold and Larry yesterday but they should have another treatment very soon. Q. Protocol requires another treatment this week? 54 1 A. Yes. 2 Q. If the Court doesn't issue the preliminary 3 injunction that we are requesting in this hearing, will you 4 be able to keep Trina open to provide those treatments? 5 A. No. 6 Q. So if the Court denies our motion, you will close 7 the clinic? 8 A. Yes. 9 Q. Blue Cross/Blue Shield of Montana is stating that 10 they shouldn't have to pay for these treatments. 11 come up with a plan to put up security in case the Court 12 decides against the plaintiffs in this matter? 13 A. 14 Have you Yes. MS. MacLEAN: Your Honor, I have in front of me 15 what's called an injunction bond. 16 it. It's an original copy of I am going to show it to the witness. 17 18 BY MS. MacLEAN: 19 Q. Julie, do you recognize that? 20 A. Yes, I do. 21 Q. What is it? 22 A. It's an injunction bond for $53,327.50. 23 Q. Has that bond already been issued? 24 A. Yes. 25 Q. Is it for the purposes in order to cover any 55 1 treatments that are or cover treatments that may happen under 2 this Court's order? 3 A. That's correct. 4 Q. So if in the end the plaintiffs don't prevail, 5 there is already security that's been issued in order to 6 ensure that your clinic can open up? 7 A. That is correct. 8 MS. MacLEAN: 9 THE COURT: Um, your Honor -- If you would hold one moment, I have 10 to give my court reporter a break so I am going to take 11 10 minutes. We are at 2:20 and can you give me a ballpark 12 time frame? I know that the defendants have witnesses. 13 know you have a few witnesses, as well. 14 thinking in terms of putting on your case? 15 MS. MacLEAN: I What is your Your Honor, I think that Dr. Elliott 16 will take an hour and I think the other remaining witnesses 17 will take the remainder of this hour. 18 THE COURT: All right. Let me just think that 19 through. 20 until 3, Dr. Elliott will take until 4? 21 22 23 So you are saying the remaining witnesses will take MS. MacLEAN: Yes, and then there is one final witness after Dr. Elliott. THE COURT: So we are going to have to figure out 24 a plan because the defendants have how many witnesses here? 25 She is just moving to a microphone. 56 1 MS. BEATTY: 2 sure. 3 witness. Certainly. We just have one for I am not yet sure if we will need to call our second 4 THE COURT: All right. Thank you. 5 So Ms. MacLean, I am going to tell you that I am 6 going to need Dr. -- This is not the final hearing in this. 7 Assuming that an injunction is granted, which is not to 8 telegraph that I have any intent whatsoever either way. 9 Dr. Elliott's testimony is going to have to be significantly 10 tightened; the same with the other witnesses so that we 11 aren't cumulative. 12 minute period, compress what you have to focus on the narrow 13 issues that I have to decide. 14 15 So I am asking you to, during this 10- MS. MacLEAN: Okay. I will do my best. Thank you, your Honor. 16 THE COURT: Thank you. So we are going to take a 17 break and I'm going to put it on mute during the break so you 18 have some ability to talk to your folks. 19 (Brief break.) 20 THE COURT: All right. Everybody is back in the 21 saddle. Everybody is back, everybody is unmuted except for 22 Dr. Elliott so please keep your sound down. 23 DR. ELLIOTT: 24 THE COURT: 25 All right? Yes, ma'am. Ms. MacLean, you can go forward. I am just going to ask you, I know that it's not easy and I am not 57 1 trying to make it sound like it is. But I am getting the 2 point. 3 statutory factors so that we can make sure we get this in. 4 can't keep this staff here after 5. 5 MS. MacLEAN: 6 THE COURT: 7 MS. MacLEAN: Lets try to keep it to the high notes as to the I I understand, your Honor. Thank you. Your Honor, before we took a break, 8 I was attempting to enter an exhibit that would be Exhibit 1 9 for the hearing today, the injunction bond. 10 And I move for entrance of that exhibit. 11 THE COURT: All right. 12 MR. AUERBACH: Is this Mr. Auerbach? Sure, your Honor. We haven't seen 13 it but pending a review of it and the opportunity to lodge 14 appropriate objections later, we don't have an objection. 15 THE COURT: I'll allow you an opportunity to make 16 a record, based on objection, if there is something you 17 haven't seen. 18 So I will admit, you said that was Exhibit 1? 19 MS. MacLEAN: Exhibit 1, yes, your Honor. It's 20 actually filed with the federal court so the opposing counsel 21 has seen it. 22 23 It's the exact same bond that was issued. THE COURT: Mr. Auerbach is nodding. can't all see each other. I know you All right. 24 You may proceed. 25 MS. MacLEAN: And your Honor, the original is here 58 1 to the extent that you order it filed with the clerk here 2 today. 3 THE COURT: 4 MS. MacLEAN: 5 THE COURT: 6 Understood. For your understanding. So it has been admitted so it should be made part of the file. 7 8 (Hearing Exhibit No. 1 was admitted into 9 evidence.) 10 11 BY MS. MacLEAN: 12 Q. Julie, one final set of questions and that is 13 related to Blue Cross/Blue Shield today argued that the 14 regular diabetic protocol should be good enough as far as the 15 non-Trina protocol that's provided in Dillon for the patient 16 plaintiffs who are still alive. 17 18 MR. AUERBACH: Objection, your Honor. This is argumentative and she also lacks foundation to testify. 19 20 Do you agree with that? THE COURT: Sustained. I sustained that objection on foundation and qualification. 21 22 BY MS. MacLEAN: 23 Q. Julie, based upon your experience, did the 24 protocol work for your husband that they used here in Dillon 25 for your diabetic treatment? 59 1 A. No. 2 Q. Here in Montana? 3 A. No. 4 Q. So the diabetic treatment that Blue Cross/ 5 Blue Shield said is covered outside of this APT/MII 6 Treatment, would that have kept your husband alive and did it 7 keep your husband alive? 8 9 10 MR. AUERBACH: Objection. Foundation and speculation. THE COURT: Hold tight. I know we have a little 11 delay but we have an objection based on foundation and 12 speculation. 13 witness has the qualifications to testify to that. 14 I am going to sustain that. MS. MacLEAN: Okay, your Honor. I don't think this I am not going to 15 ask any further questions; just try to push it. 16 further questions for Julie at the time. 17 18 19 20 21 22 23 THE COURT: All right. Thank you. I have no You may call your next witness. MR. AUERBACH: Your Honor, can I have the opportunity to ask Ms. Briggs questions? THE COURT: I apologize, I apologize. I tried to push this faster than it even needs to go. Ms. Briggs, hold tight. Please wave your hand or 24 something if you can't hear Mr. Auerbach and I'm going to ask 25 my staff to turn the camera so that Ms. Briggs can see 60 1 Mr. Auerbach and know who is asking the questions. 2 All right. 3 MR. AUERBACH: 4 Thank you. Your Honor, do you mind if I stand at counsel table? 5 THE COURT: 6 Can you hear him okay, Ms. Briggs? 7 THE WITNESS: 8 THE COURT: 9 10 Well, I just am asking, I know you may Mr. Auerbach because we are dealing with electronics here? THE WITNESS: Yeah. He is very faint but I will do my best. 13 14 I do have a little trouble hearing. have a hearing problem but I am asking can you hear 11 12 No, that's fine. THE COURT: This podium may have a little better mic for people to hear on. 15 You may proceed. 16 17 CROSS-EXAMINATION 18 BY MR. AUERBACH: 19 Q. Ms. Briggs, my name is Dan Auerbach. I was 20 introduced previously. 21 representing Blue Cross/Blue Shield of Montana in this case. 22 Thank you for your testimony today. 23 questions for you. 24 25 I am one of the attorneys I had a few follow-up First, taking you back to 2015, you spoke earlier about the creation of Trina Health of Montana as a clinic 61 1 down in Dillon. 2 spoke to two other individuals about receiving APT Treatment; 3 is that correct? 4 A. 5 You indicated that your husband and you Yes. MS. MacLEAN: Objection. It misstates the 6 characterization, the statement mischaracterized the 7 testimony. There was no other two individuals. 8 THE COURT: 9 THE WITNESS: 10 She already answered. I guess I don't understand the question. 11 THE COURT: Hold tight, hold tight. Everyone 12 needs to take turns and when an objection is made, I need an 13 opportunity to rule. So the witness has already answered the 14 question; overruled. The record will speak for itself. 15 16 BY MR. AUERBACH: 17 Q. And Ms. Briggs, in the fall of 2015, you spoke to 18 Barry Briggs and Harold Grogan about receiving APT Treatment 19 in Montana, correct? 20 A. Actually they spoke to me. 21 Q. Do you know how Mr. Grogan and Barry Briggs knew 22 23 of APT prior to you speaking with them? A. Because Dillon is a small town and everyone in 24 Dillon knew that my husband was traveling once a week down to 25 Arizona to get treatments and so they were well aware of what 62 1 2 3 the treatment was doing for Ron. Q. So you and your husband were approached by Barry Briggs and Mr. Grogan; is that correct? 4 A. Yes. 5 Q. Did you and your husband seek out any other 6 patients for APT Treatment in Montana prior to opening the 7 clinic in Dillon? 8 9 A. We talked to people about the treatment but I don't believe we sought out patients. We had an open house 10 and people came to the open house and learned about what the 11 treatment was and we had a sign and people called. 12 Q. Did you do any advertising relating to the 13 treatment that the Trina Health Clinic in Dillon would offer 14 once it opened? 15 A. The only thing that I really advertised was when 16 we first, when Ron was going down to Arizona, I put a notice 17 in the Dillonite Daily and I said, "Please help. 18 knows my husband knows that he has had diabetes for over 19 50 years and he has been traveling down to Arizona for --" I 20 don't know how long it was -- "but we with like to get a 21 Trina Health Clinic up here in Montana. 22 would want to support my husband and anyone that would want to 23 have a Trina Health Artificial Pancreas Therapy Clinic here in 24 Montana, call down to Sacramento and please let them know that 25 we need a treatment up here and they need to put a clinic -- Anyone that And so anyone that 63 1 or we need a clinic up here and we need to put, they need to 2 put a clinic up here," because we didn't understand how any of 3 that worked. 4 And so there were, they jammed the phone lines in 5 California and so Ford Gilbert called and talked to my husband 6 and he said, "If you would like to put a Trina Health Clinic 7 up in Montana, then you would go ahead and make arrangements 8 to do that". 9 only advertising that we did, I believe. 10 And so that's what we did and that's really the As far as the open house and all of that, we 11 advertised for that, but there was, we haven't really 12 advertised -- 13 Q. All right. Ms. Briggs, there was a lot to that. 14 A. Just word of mouth. 15 Q. I didn't mean to cut you off. I'm sorry. 16 your answer. 17 your husband got the idea to start a Trina Clinic in Dillon, 18 that came from his visits to the Arizona treatment health 19 clinic; is that right? 20 21 22 23 24 25 A. I didn't track all of that. There was a lot to So when you and Yes because we couldn't afford to continue to have him travel once a week down to Arizona. Q. So when you got back from Arizona, you contacted Trina Health USA in California; is that correct? A. No, we didn't. We put an advertisement in the local paper, the little rag sheet and I asked for help from 64 1 the community because we needed a clinic up here to help my 2 husband and also to help other people in the community. 3 we had no intention of putting a Trina Health Clinic in 4 Dillon, Montana. 5 the treatment was covered by Blue Cross, we didn't know how 6 any of that worked. 7 the corporate office because there was an outcry from the 8 people in Dillon calling to get a clinic here in Dillon, and 9 they jammed the phone lines in California and Ford Gilbert 10 We were trying to get my husband treated, And when we talked to Ford Gilbert from told us that -- 11 THE COURT: 12 THE WITNESS: 13 THE COURT: 14 And Ms. Briggs, Ms. Briggs? Yes. I need you to listen carefully to the question and just answer the question. 15 THE WITNESS: 16 THE COURT: Okay. And I am not trying to limit you but 17 every time you get a question, you go off onto paragraphs of 18 a narrative and we don't have -- 19 THE WITNESS: 20 THE COURT: I'm sorry. -- time for that and it's really 21 hard to listen to as well. 22 question? 23 24 25 THE WITNESS: So will you just focus on the Okay. I guess the advertising question was no, we didn't really advertise a whole lot. THE COURT: Thank you. 65 1 BY MR. AUERBACH: 2 Q. Thank you, Ms. Briggs. So you spoke to Ford 3 Gilbert from the Trina Clinic in Arizona, correct -- Excuse 4 me, of California? 5 A. Yes. 6 Q. And Mr. Gilbert explained to you and your husband 7 how to open a Trina Clinic in Montana; is that right? 8 A. Yes. 9 Q. And you said you didn't know what you would need 10 to do to open a clinic before you spoke to him; is that 11 right? 12 A. That's correct. 13 Q. You and your husband became the owners of the 14 Trina Clinic in Dillon, correct? 15 16 MS. MacLEAN: Objection. Misstates the facts in testimony. 17 MR. AUERBACH: 18 THE COURT: I'll rephrase or withdraw. Hang on. Overruled. 19 20 BY MR. AUERBACH: 21 Q. 22 Ms. Briggs, did you and your husband own the Trina Clinic in Dillon? 23 A. My husband owned the clinic in Dillon. 24 Q. Okay. 25 So would you agree with me that your husband had a financial interest in having more patients 66 1 2 3 4 attend the Trina Health Clinic in Dillon? A. Financial interest, I -- Yes, that would be true but we didn't really, we had the patients that were here. Q. But at the end of the day, if your husband owns 5 the clinic, he can get his treatment locally; if he has more 6 patients come in, he gets to make money, stay home and get 7 his treatment. 8 A. 9 help my husband. Is that fair to say? Sir, this was not to do with money. This was to We were planning to move to Arizona so that 10 he could get his treatment. 11 other people in our community with a treatment that was very 12 beneficial to my husband and I knew would be very beneficial 13 to other people in the community. 14 understand how something that can be so beneficial to people 15 that can help -- I would say every single patient in our 16 clinic had neuropathy reversed and so I -- 17 THE COURT: We also were planning to help And I honestly don't Ms. Briggs, Ms. Briggs? I understand, 18 I do understand how you feel. 19 you have to say but some of the information you are giving in 20 these answers is information you have already given so I want 21 you to just answer the question that he is asking you. 22 THE WITNESS: I am listening hard to what I'm sorry. 23 24 BY MR. AUERBACH: 25 Q. Ms. Briggs, we can move on to a related topic, I 67 1 guess. Did you ever speak to any patients, prospective 2 patients of the Trina Clinic in Dillon that had insurance 3 other than Blue Cross/Blue Shield of Montana? 4 A. Yes, we had other patients with other insurance. 5 Q. And did you ever treat those patients with other 6 insurance at Trina Health in Dillon? 7 A. Yes. 8 Q. Do you know what the result of your request for 9 payment from those insurance was for the APT Treatment? 10 A. Yes. 11 Q. And what was that result? 12 A. Was that Blue Cross was paid and Medicare was 13 paid. 14 some other insurances that were approved. 15 off the top of my head which insurances those are. 16 We had Pacific Source that was approved and there were Q. I can't tell you And how many patients did you have at 17 Trina Health since the clinic was created that were insured 18 by a carrier other than Blue Cross/Blue Shield of Montana? 19 A. I don't really know. 20 Q. But as you sit here today, the only two patients 21 of Trina Health of Montana are Barry Briggs and 22 Harold Grogan; is that correct? 23 A. That is correct. 24 Q. Do you know when the last time Trina Health of 25 Dillon saw a patient that wasn't one of those two individuals 68 1 or your husband? 2 A. It was before the clinic closed. 3 Q. Do you know why the other patients that were 4 insured by other carriers were no longer patients of 5 Trina Health as of the time it closed? 6 A. I'm sorry. 7 Q. Sure. Can you repeat that? Do you know why the patients that were 8 insured by other insurers other than Blue Cross/Blue Shield 9 of Montana are no longer patients of Trina Health in Dillon? 10 A. We had an audit with the Medicare and it was, they 11 were not going to pay for six months and so at the very same 12 time and while they were doing their internal audit. 13 THE COURT: I am not sure I understand that 14 answer. I think the question was as I understand it -- and I 15 don't mean to interfere with your cross-examination -- but as 16 I understand it, what Mr. Auerbach is asking you is at the 17 time that Blue Cross/Blue Shield issued its cease and desist 18 letter, were other patients being treated who were being 19 insured by other companies? 20 asking? 21 THE WITNESS: 22 THE COURT: 23 THE WITNESS: 24 THE COURT: 25 Do you understand what I am Yes. So were there? Yes. And so did the patient, did the clinic continue treating those patients that were insured by other 69 1 carriers? 2 THE WITNESS: 3 THE COURT: 4 THE WITNESS: No. And why is that? At the same time there was, Medicare 5 sent us a notice that they were doing a standard audit that 6 would take six months and we were not going to get paid or 7 reimbursed for services until after the audit was completed. 8 9 THE COURT: So are you saying that those patients were Medicare patients? 10 THE WITNESS: 11 THE COURT: I'm sorry. I couldn't hear you. Are you saying those patients that 12 were not insured by Blue Cross/Blue Shield were Medicare 13 patients then? 14 THE WITNESS: 15 THE COURT: Yes, some of them. I just don't understand your answer 16 then. I don't understand why you didn't continue to treat 17 them because of a Medicare audit. 18 THE WITNESS: 19 THE COURT: 20 THE WITNESS: 21 THE COURT: 22 23 We were not reimbursed. By whom? When they were doing the audit. So are you saying Medicare would not reimburse or the other carriers would not reimburse? THE WITNESS: No. We -- The other insurances were 24 paying but we can't, we couldn't keep the doors open with -- 25 We had 10 patients, 10 to 15 patients. 70 1 2 THE COURT: All right. Thank you. I apologize for interrupting. 3 MR. AUERBACH: 4 THE COURT: 5 MR. AUERBACH: Thank you, your Honor. I am not sure I understand the answer. No problem. 6 7 BY MR. AUERBACH: 8 Q. 9 Ms. Briggs, so when you said you had 10 to 15 patients, was that as of April of 2017, the time you 10 received the Blue Cross/Blue Shield's cease and desist 11 letter? 12 A. Yes. 13 Q. And three of those -- 14 A. But we couldn't. 15 Q. Sorry. 16 A. We couldn't bill under, we can't bill under the 17 OIVIT and that's the problem. 18 THE COURT: Okay. Hold tight now. 19 Mr. Auerbach ask you the question. Let 20 21 BY MR. AUERBACH: 22 Q. Ms. Briggs, I promise I will get you to where I 23 am trying to get an answer to. Of those 10 to 15 patients, 24 three of them, I believe the record establishes, were the 25 three individuals who originally filed the Petition in this 71 1 case: your husband, Barry Briggs, and Harold Grogan. 2 correct? Is that 3 A. Yes. 4 Q. And of the remaining patients, I am now saying 5 6 that's 7 to 12, some were Medicare patients; is that right? A. Some and there were some Blue Cross and some 7 Pacific Source and I believe, United. 8 You would have to talk to the billing people about all that. 9 10 11 12 13 14 15 16 Q. I am not really sure. And would the billing people in your office be Taylor Romine? A. She is from the corporate office and yes, she would, she would know. Q. Is there anybody else who you were referring to when you said the billing office? A. Our clinic is closed. I had to let go all of my employees and so the people -- 17 THE COURT: Ma'am, ma'am, he understands that. He 18 is just asking the question who are the people in the billing 19 office that you are referring to. 20 THE WITNESS: That would be Taylor. 21 22 BY MR. AUERBACH: 23 Q. Okay. Thank you. So what happened to the 24 patients that you, that Trina Health in Dillon was treating 25 in April of 2017, when Trina closed its doors? 72 1 A. We had to call them and let them know that we 2 couldn't bill under what was being said that we had to bill on 3 under, the OIVIT so we told -- 4 5 THE COURT: Ma'am, ma'am, did you hear what the question was? 6 THE WITNESS: Yes. We closed the clinic. 7 8 BY MR. AUERBACH: 9 Q. And so those patients no longer received 10 treatment at your clinic in Dillon after April 12 or 11 thereabouts, the date of the cease and desist letter? 12 A. Yes, thereabouts. I don't know the exact time. 13 Q. Why wouldn't Trina, why did you not keep the 14 doors open in Dillon for Trina's clinic in 2017 when you had 15 other patients that were not insured by Blue Cross/ 16 Blue Shield? 17 A. Because I can't bill under OIVIT. 18 Q. Is it your testimony that Blue Cross's letter in 19 April 2017 applied to all insurance companies as well as 20 Medicare? 21 A. I am going to have to refer you to the billing 22 people because I was advised that we needed to close the doors 23 because I couldn't bill under the OIVIT and so they are the 24 ones that would have more information about all of that. 25 Q. Okay. Are you aware of any other insurance 73 1 companies that told your clinic in Dillon that it could not 2 bill for the APT Treatment it was providing in 2017? 3 THE COURT: He is asking you if any other 4 insurance companies gave you a cease and desist letter like 5 the one from Blue Cross/Blue Shield. 6 THE WITNESS: 7 and desist order from -- I, no, no. I don't believe I received a cease 8 9 10 11 BY MR. AUERBACH: Q. Do you have an understanding of why Medicare decided that you could not bill for services for six months? 12 THE COURT: Did you hear that? 13 THE WITNESS: There, there may be one and I don't 14 really know. I will have to refer you to the billing people 15 because I, I don't really understand all of that. 16 17 BY MR. AUERBACH: 18 Q. Do you know whether the Medicare communications 19 to the clinic came prior to Blue Cross/Blue Shield's letter 20 in April of 2017? 21 A. I don't recall. 22 Q. But the Medicare audit or their review of your 23 claims, that contributed to the closure of Trina's Dillon 24 Clinic, correct? 25 A. No. 74 1 Q. So the only reason you closed the clinic was 2 because of Blue Cross, despite the fact that you also could 3 not bill any other health insurer or Medicare for APT 4 services; is that right? 5 MS. MacLEAN: Objection. 6 misstates the facts in the record. 7 THE COURT: 8 THE WITNESS: Overruled. Misstates the facts and You can answer. Can you repeat it? I'm sorry. 9 10 BY MR. AUERBACH: 11 Q. Sure. Ms. Briggs, with all due respect, I am 12 trying to understand why Trina Health closed its doors in 13 April of 2017 solely due to Blue Cross's letter when there 14 were other insurance companies and Medicare who also would 15 not pay for APT, according to your testimony. 16 A. We, we had a very limited number of patients and 17 when, just -- This was, we never made any money on this. 18 fact, it cost us a lot of money to do this because we felt so 19 strongly about it. 20 really don't remember which came first, the audit request or 21 the Blue Cross thing. 22 was advised that we should, we would need to -- I wasn't able 23 to, without being reimbursed, I was not able to keep the doors 24 open. And Taylor and -- Taylor can speak to when we received 25 what. I don't really know. I don't recall. In It must have been -- I I really don't know. All I know is I 75 1 2 Q. Ms. Briggs, do you know why the, why Medicare audited the Trina Clinic in Dillon in 2017? 3 MS. MacLEAN: Objection, your Honor. This line of 4 questioning has nothing to do with the case that we are 5 presenting today. 6 THE COURT: Well, I think, I think it is relevant 7 because the question of why this business was shut down is in 8 issue here and it is an issue for the Court to decide as to 9 causation and who caused the irreparable injuries. So I am 10 going to ask all counsel be cognizant of the time but I am 11 going to overrule the objection for that reason. 12 THE WITNESS: Well, it was my understanding that 13 this was a standard thing that they do, this, do audits on -- 14 and from my understanding, if they do an audit in a hospital, 15 it's no big deal because hospitals can just keep running. 16 And so from what I understood, it was just standard 17 procedure. 18 19 BY MR. AUERBACH: 20 Q. And I am getting to the end of this subject but 21 Ms. Briggs, is it your testimony that Trina Health in Dillon 22 could not stay open with the payments from other patients 23 outside of Blue Cross and Medicare? 24 25 A. We didn't have any private pay. And if you have 15 patients, if you lose one patient, it's -- Medical people 76 1 are expensive. 2 Q. Okay. I understand your testimony, I believe. 3 You just said medical people are expensive, and I recognize 4 that. 5 would agree. 6 yesterday; is that right? I think we have doctors all around this case that You said that Harold Grogan got his treatment 7 A. I didn't -- Harold what? 8 Q. Grogan received APT Treatment yesterday? 9 A. Yes. 10 Q. How did you have a doctor handy when the order 11 just came down on Friday approving the temporary restraining 12 order? 13 A. We have a nurse practitioner that works for the 14 clinic and I have a doctor that oversees the clinic. 15 nurse practitioner is partially retired and she was available. 16 And we, we had visited with her and asked her if she could 17 come back. 18 treatments. 19 20 Q. The This is the woman that has been doing the Okay. And do you pay this woman to do the treatments that Trina in Dillon -- 21 A. Yes, she has been paid to do the treatments at 22 Trina in Dillon. 23 open. She was our nurse practitioner when we were 24 Q. And she was an employee until April of 2017? 25 A. I guess I don't -- She is a contract -- I don't 77 1 know if -- I don't want to get caught up in all these words 2 and I am kind of -- But she works as a contract laborer where 3 she does her own taxes so I don't -- 4 Q. And Ms. Briggs, I am not worried about her 5 classification. 6 you laid everybody off when the clinic closed in April of 7 last year. 8 off in whatever capacity she worked in? I was just trying to understand. You said Was she one of those individuals that was laid 9 A. Yes. 10 Q. And she is still in Dillon so you called her up 11 or someone called her up after Friday's order was issued and 12 asked if she could come and do treatment for Barry Briggs and 13 Harold Grogan; is that right? 14 A. Yes. 15 Q. Did you call any of the other former patients of 16 Trina Health in Dillon to let them know they could come in 17 for treatment? 18 19 20 A. No because we, we can only treat the ones that were on the document, whatever these documents are called. Q. What I am not understanding though is you said 21 that as a result of the Blue Cross letter, you couldn't bill 22 any insurance company after April of 2017 for APT Treatment. 23 So if -- 24 25 MS. MacLEAN: testimony of the witness. Objection. That misstates the 78 1 THE COURT: Sustained. 2 3 BY MR. AUERBACH: 4 Q. Ms. Briggs, was it your understanding that 5 because of Blue Cross's letter to the clinic in April 6 of 2017 that you couldn't bill any insurance company for 7 APT Treatment? 8 A. No. 9 Q. And so why did you not continue to treat the 10 I cannot, I couldn't bill Blue Cross. patients that didn't have Blue Cross? 11 THE COURT: Did you hear that? 12 THE WITNESS: 13 that were not Blue Cross? 14 MR. AUERBACH: 15 THE WITNESS: 16 Why did I not treat the patients Correct. I think we already discussed that because I didn't have enough patients to treat. 17 18 BY MR. AUERBACH: 19 Q. Okay. So there was 10 to 15 patients in April of 20 2017, you testified earlier. 21 and your testimony is the remaining patients would not be 22 sufficient to keep the doors open for the clinic. 23 characterize your testimony correctly? 24 25 A. Three of them were Blue Cross Did I Are you talking about yesterday when I called Harold and Barry in? 79 1 Q. Now, Ms. Briggs, I will rephrase that for you. 2 In April of 2017, there were three Blue Cross patients, we 3 have established that, at Trina Health. 4 testimony that the other patients that were not insured by 5 Trina Health were not sufficient for the clinic to stay open 6 as of April 2017? 7 A. 8 9 10 I don't understand your answer. THE WITNESS: I didn't have enough patients to keep the clinic open. THE COURT: How many patients did you have when you made the decision to close the clinic? 15 16 Does that mean you agree with the question that was just asked or you disagree? 13 14 Not at that time. THE COURT: 11 12 And is it your THE WITNESS: I can't tell you for sure at this point in time. 17 THE COURT: Do you have any approximate idea? 18 THE WITNESS: I would say maybe 10 but, 8 to 10. 19 It would fluctuate because we had some people that would come 20 from -- 21 THE COURT: And ma'am, I am not trying interrupt 22 you but I just, I was just interested in the answer to the 23 question. 24 for that but we are now past 3 so I just want to keep this 25 tight. So I understand that you have a thinking process 80 1 2 MR. AUERBACH: I'll try and get through this, your Honor. 3 4 BY MR. AUERBACH: 5 Q. Ms. Briggs, Blue Cross/Blue Shield of Montana 6 never told Trina Health in Dillon that you could not provide 7 APT services, correct? 8 9 A. patients had insurance coverage. 10 11 I received the cease and desist letter and the THE COURT: My husband -- Ma'am, ma'am, ma'am. I'm sorry but I just want you to listen to the question and answer it. 12 THE WITNESS: Okay. Okay? Okay. 13 14 BY MR. AUERBACH: 15 Q. Would you agree with me that Blue Cross/ 16 Blue Shield of Montana never advised Trina that it could not 17 provide APT services? 18 19 THE COURT: Did Blue Cross ever tell Trina that it was prohibited from providing those services? 20 THE WITNESS: No. 21 22 BY MR. AUERBACH: 23 Q. 24 25 And similarly, did Blue Cross/Blue Shield ever tell Trina of Montana to close its doors? A. Not directly. 81 1 Q. I'm sorry. I am going to have to ask you to 2 explain. 3 When you say, "not directly", how did Blue Cross/Blue Shield 4 advise Trina to close its doors? 5 I mean it's either a yes or no question, I believe. A. Well, when I received information that says that I 6 can't bill, then I believe that's telling me that I can't stay 7 open. 8 9 Q. And Ms. Briggs, the letter speaks for itself and the judge has certainly read that so I won't go into that, 10 but you do understand the letter advised Trina Health in 11 Dillon of the proper coding to use, correct, for APT 12 Treatment? 13 MS. MacLEAN: 14 THE COURT: 15 MS. MacLEAN: 16 THE COURT: Objection, your Honor. What is the objection? Calls for a legal conclusion. Overruled. 17 18 BY MR. AUERBACH: 19 Q. Ms. Briggs? 20 A. I would need to -- If you are asking me about 21 coding, I would need for -- I have never had anything to do 22 with coding. 23 is the person that talks to our nurse practitioner about 24 coding. 25 could not bill under OIVIT. I would need for you to visit with Taylor. I don't know. She All I know is I was advised that we 82 1 Q. And I respect your deference to Taylor on those 2 issues but Ms. Briggs, you testified earlier about coding and 3 you testified about the use of the G9147 code that Blue Cross 4 advised Trina Clinic to utilize if billing for APT services. 5 That's why I am asking you about that. 6 A. Okay. 7 Q. Right. 8 That's in the cease and desist letter here. And you responded that that would be fraud if you used that code. Do you recall that testimony? 9 A. That's what I was advised. 10 Q. But do you have any independent understanding of 11 whether that's fraudulent to use the G code that's referenced 12 in the cease and desist letter? 13 14 15 16 A. I need to depend on the people that have the knowledge to explain to me what is right and what is wrong. THE COURT: So what you are saying -- Ma'am, ma'am, I just want you to -- 17 THE WITNESS: 18 THE COURT: Yes. I want you to focus on the question. 19 I think he was asking whether you have knowledge as to why 20 using that code was fraudulent. 21 that question? 22 THE WITNESS: 23 THE COURT: 24 25 And what is your answer to Because I was told it was. All right. Thank you. 83 1 BY MR. AUERBACH: 2 Q. Ms. Briggs, other than your counsel, I don't want 3 to know what was discussed between Ms. MacLean and other 4 legal counsel and you but you said you were advised. 5 told you that it would be fraud to use the G code for APT 6 services? 7 A. I don't directly remember. 8 Q. Do you recall whether it was someone at 9 Who Trina Health in California? 10 A. It may have been my attorney. 11 Q. Okay. 12 A. I don't, I honestly don't remember. 13 Q. Would Taylor Romine be the individual who 14 selected the coding to bill for the APT services that your 15 clinic provided? 16 A. 17 18 THE COURT: Ma'am, ma'am? He is asking, he is asking you who decided what code to use. 19 20 I don't know about the billing so -- THE WITNESS: Was it Taylor? It was the billing department at Trina corporate. 21 22 BY MR. AUERBACH: 23 Q. Okay. Just a couple more questions for you, 24 Ms. Briggs. After April of 2017, did your husband receive 25 any other diabetes treatment? 84 1 A. No. Well, he went to the doctor and they provided 2 him with what he, what they do basically. 3 the doctor, they just check your A1c to make sure your A1c is 4 okay. 5 pain from neuropathy, I think, and they put him on more and 6 more blood pressure medication because his blood pressure was 7 going up because he wasn't getting his treatments. 8 9 10 11 12 13 14 15 16 17 Um, when you go to And they put him on pain pills because he was having Q. Okay. And does -- Ms. Briggs, I appreciate that. I just was wondering whether he received any other diabetes treatment specific to his diabetes condition. A. He needed more insulin because the treatment helps you to keep your, you don't need as much insulin. Q. Did he get an insulin treatment after April of 2017? A. He was, he was a Type 1 diabetic. He always had insulin. THE COURT: Well, ma'am, what he is trying to ask 18 you about is whether or not your husband got medical 19 treatment and if so, what, after the clinic closed. 20 what he is asking. 21 THE WITNESS: Yes. That's He visited the doctor probably 22 every three months or so and they kept increasing his 23 medications because he needed more medications. 24 25 85 1 BY MR. AUERBACH: 2 Q. Okay. Did you your husband speak with the Trina 3 providers there in Dillon about providing the APT Treatment 4 to your husband regardless of whether there was insurance 5 coverage? 6 A. I can't pay somebody to -- If I was going to pay 7 them to do treatment for my husband, I guess -- They charge 60 8 bucks an hour and the treatment takes about 5 hours and that's 9 not the supplies. 10 Q. 11 husband spoke -- 12 A. 13 No, I didn't talk, no, I didn't talk to them about providing treatment. 14 15 And my question was just whether you and your Q. Did you or your husband speak to any other Trina providers about providing APT Treatment after April 2017? 16 A. No. 17 MR. AUERBACH: 18 (Off the record.) 19 MS. MacLEAN: 20 THE COURT: 21 MR. AUERBACH: 22 One moment, your Honor. Your Honor, may I have redirect? One moment. I have no further questions at this time. 23 THE COURT: Yes, you may redirect keeping in mind 24 the time. I am trying to communicate with my staff to find 25 out if we have, we won't have any time on Thursday but we may 86 1 have some on Friday. 2 I don't know. All right Ms. MacLean. 3 4 REDIRECT EXAMINATION 5 BY MS. MacLEAN: 6 Q. 7 to close. 8 A. 9 10 11 Julie, what was the thing that caused your clinic I received the cease and desist letter. That's when we closed the clinic. Q. It was the cease and desist from Blue Cross/ Blue Shield that caused you to close the clinic? 12 A. Yes. 13 Q. Before that, you had no plans to close the 14 clinic? 15 A. No. 16 Q. Can you speak into the microphone? 17 A. No, I didn't plan on closing the clinic. 18 Q. Although your husband, Harold, was able to seek 19 outside treatment to treat basically the symptoms of the 20 diabetes, did that keep him alive? 21 A. No. 22 Q. What treatment kept him alive? 23 A. His Artificial Pancreas Treatment kept him alive. 24 Q. So whether or not he was able to seek other 25 treatment that's keeping him alive, is that relevant to you 87 1 or him right now? 2 A. Whether the doctors could provide something? 3 Because they hadn't provided anything. 4 mean. 5 Q. I don't know what you What I am saying is there was insinuation that 6 you could have had other treatment to treat his diabetes 7 other than APT that would have done the same thing as APT. 8 9 A. No, he tried for years. My husband tried to eat healthy, like the doctors wanted him to do. No, there was 10 nothing that anybody was doing or could do other than the 11 treatment that would help him. 12 13 14 15 16 17 Q. And what is the only reason that you have agreed to open the clinic back up at this time one day a week? A. (Crying) Because I know that these guys need help and I think my husband would want that. Q. So do you know if they had any -THE COURT: Hold on, hold on. 18 little trouble hearing. 19 need to understand what you are saying. 20 THE WITNESS: We are having a I understand this is emotional but we The reason that I wanted the clinic 21 open for Harold and Barry is because I know that Harold and 22 Barry have had some problems since the clinic has closed, 23 medical problems. 24 before they started the treatment and after they started the 25 treatment, I know that they were doing great. And I know that they were not doing well And since the 88 1 clinic has closed, I can see that they are suffering the 2 effects just like my husband, and I would like to help them. 3 4 5 6 7 8 BY MS. MacLEAN: Q. You don't want them to have the same thing to happen as your husband? A. No, I don't. And Joan told me that Harold is not doing well and she is afraid -- 9 THE COURT: All right. Ms. MacLean, this is 10 hearsay and I think I understand the point and I think we are 11 sort of circling around with the same testimony. 12 13 And I don't mean any disrespect, Ms. Briggs, but I just want to get to the next witnesses. 14 MS. MacLEAN: Yes, your Honor. 15 No further questions for Ms. Briggs. 16 THE COURT: 17 Any redirect? 18 MR. AUERBACH: All right. I understand. Thank you. Your Honor, the only redirect is to 19 ask the same question that I asked her earlier that she gave 20 a different answer as to why the clinic closed. 21 one pointed question on that. I have just 22 23 RECROSS-EXAMINATION 24 BY MR. AUERBACH: 25 Q. Ms. Briggs, the fact that there was a federal 89 1 investigation of Trina Health in Dillon did not change, did 2 not affect your decision to close the clinic in April of 2017 3 and then reopen it in January of 2018? 4 A. No. 5 MR. AUERBACH: 6 THE COURT: 7 (Witness excused.) 8 THE COURT: 9 10 11 12 Nothing further, your Honor. Thank you. Ms. MacLean, you can call your next witness. MS. MacLEAN: Your Honor, the plaintiffs call Barry Briggs. THE COURT: Ms. MacLean, I don't want to tell you 13 how to do your case but to the extent that I have heard the 14 testimony from Ms. Briggs, if you can focus on the new 15 evidence that you have for Mr. Briggs, I would appreciate it. 16 MS. MacLEAN: 17 THE COURT: 18 THE WITNESS: Yes, your Honor. Good afternoon, Mr. Briggs. Good afternoon, Judge. 19 20 BARRY BRIGGS, 21 called as a witness, and having been first duly sworn, was 22 examined and testified as follows: 23 24 25 90 1 DIRECT EXAMINATION 2 BY MS. MacLEAN: 3 Q. Please state your name for the record. 4 A. Barry Briggs. 5 Q. And Mr. Briggs, where do you reside? 6 A. I reside in Dillon, Montana. 7 Q. And what do you do in Dillon? 8 A. I am a general contractor. 9 Q. And explain what you do for your work. 10 A. We do a lot of construction additions to houses, a 11 lot roofing and I have been doing this for 35 years. 12 13 THE COURT: your mouth please. 14 15 Could you hold that mic right up to THE WITNESS: I have diabetes and it started to take hold of things so things are changing without treatment. 16 17 18 19 BY MS. MacLEAN: Q. Mr. Briggs, did you at some point become a patient of Trina Health of Montana? 20 A. Yes, I did. 21 Q. At the time, was that in 2015? 22 A. Yes, I was. 23 Q. And did you have a Blue Cross/Blue Shield of 24 Montana policy? 25 A. Yes, I did. 91 1 2 Q. And did you have one in 2017 also when the clinic closed? 3 A. Yes, I did. 4 Q. And I am handing you what was Exhibit 3 to the 5 Petition. 6 A. Yes, I do. 7 Q. Please look at the second page. 8 Do you see that? Is that your policy? 9 MS. MacLEAN: 10 I had the wrong exhibit. I'm sorry, your Honor. Apparently, 11 12 BY MS. MacLEAN: 13 Q. 14 This is Petition Exhibit 2. Do you see that second page. 15 A. Yes, that's my policy. 16 Q. When you started treatment in 2015 with Trina, 17 did you understand that your APT/MII treatments were covered? 18 A. Yes, I did. 19 Q. By Blue Cross/Blue Shield of Montana? 20 A. Yes. 21 Q. And do you continue to have a Blue Cross/ 22 Blue Shield of Montana policy? 23 A. Yes, I do. 24 Q. As far as you know, has the plan language 25 changed? 92 1 A. As far as I know, nothing has changed. 2 Q. Did Blue Cross/Blue Shield of Montana ever tell 3 you before April 2017 that your APT/MII treatments were not 4 going to be covered? 5 A. No, I was not aware of it. 6 Q. What was the status of your health prior to your 7 treatment at Trina of Montana? 8 A. 9 diabetes. It was pretty much on the downward spiral with I was constantly to the doctors because I had 10 infections on my feet, I had lost toes and just a lot of 11 things were going on with my body and I just needed some help 12 and through this treatment, um, I battled a lot of health -- 13 THE COURT: Hold on one minute, Ms. MacLean. 14 are having some trouble hearing Mr. Briggs. 15 you can move your mic closer to him. 16 of you seems to be producing a little better sound. 17 THE WITNESS: 18 THE COURT: 19 21 THE COURT: 24 25 The one that's in front Just not a good sound system. THE WITNESS: 23 I don't know if Is that better? Slightly. 20 22 Okay. Is that better, your Honor? It's better the closer you are to the mic. THE WITNESS: Okay. We 93 1 BY MS. MacLEAN: 2 Q. I'm putting in front of you two affidavits, one 3 that you had originally executed on October 23, 2017. 4 remember that affidavit? Do you 5 A. Yes, I do. 6 Q. And are the statements that you made in that 7 affidavit, do they remain true? 8 A. Yes, they are very true. 9 Q. Then you have signed an executed supplemental 10 affidavit that was filed January 23, 2018. 11 in front of you? 12 A. Yes. 13 Q. Are the statements that you made in the affidavit 15 A. Yes, they are. 16 Q. And can you tell me whether anybody in Montana or 14 Do you have that true? 17 in Dillon or anywhere in Montana was able to help your 18 diabetes from declining significantly prior to the treatment 19 that you received from Trina? 20 A. Um, very little help. Um, they just don't know 21 a lot of about diabetes, I think, and I don't know. 22 getting well enough with treatment so I sought treatment 23 elsewhere. 24 25 THE COURT: I wasn't Hold tight, hold tight one minute. Will you repeat your sentence please because we didn't catch 94 1 that. Speak right into the microphone. 2 didn't hear, we couldn't understand your answer. 3 4 THE WITNESS: microphone. 5 Okay. I will stay with the What was the question? THE COURT: Mr. Briggs, we I'm sorry. Well, I didn't ask the question, 6 Ms. MacLean did so I think that she asked you what the, what 7 your health situation was before you began getting treatment 8 at Trina. 9 Is that accurate, Ms. MacLean? 10 11 MS. MacLEAN: Honor. Yes. That's accurate enough, your Thank you. 12 THE COURT: 13 clearly right into the microphone. 14 Can you describe it? THE WITNESS: Okay. Speak slowly and I had a lot of feet problems, 15 I had amputations on my feet, I had several blisters on my 16 feet. I had (indiscernible) -- 17 18 19 20 THE COURT: "blisters"? You had what? I didn't understand that. THE WITNESS: I had blisters and I had several amputations. 21 THE COURT: 22 THE WITNESS: 23 several (indiscernible). 24 treatment from Trina Health. 25 What did you say after THE COURT: Amputations. From several (indiscernible), from And this was before I had any Understood, thank you. Thank you. I 95 1 will let Ms. MacLean ask the next question. 2 3 BY MS. MacLEAN: 4 Q. During your, did you have to go to the emergency 5 room and to physicians often before you had this treatment 6 from Trina. 7 A. Yeah. 8 Q. Was that as a result of your diabetes-related 9 10 illness? A. 11 12 I was quite regular there. (Indiscernible.) THE COURT: Hang on, hang on. that sentence. 13 THE WITNESS: 14 THE COURT: 15 I didn't understand Multiple problems with diabetes. You said, "multiple problems with the diabetes"? 16 THE WITNESS: 17 THE COURT: 18 THE WITNESS: Yes. Okay. Thank you. Yes. 19 20 BY MS. MacLEAN: 21 Q. That put you in the hospital several times? 22 A. Yes. 23 I was in the hospital several times related to diabetes. 24 Q. Including amputations? 25 A. I have had four amputations. 96 1 Q. 2 treat at Trina? 3 A. 4 When you started treating, how did you come to Well, Ron and Julie have been friends of ours. Our name is the same but we are not related. 5 THE COURT: I couldn't understand that. I know 6 that you may be having trouble or maybe you are nervous but 7 you really need to speak clearly and loudly. 8 9 THE WITNESS: friends of ours. Okay. Ron and Julie were good We are not related at all. I spoke with 10 Ron and Julie several times about that situation that Ron had 11 been going down to Arizona for treatment and I just mentioned 12 several times I wish we had one here and through their hard 13 work, they made that happen. 14 15 BY MS. MacLEAN: 16 Q. Then you started treating after they opened? 17 A. I started treating, I was probably their first 18 patient. 19 facility. 20 Q. 21 22 I probably had over 150 treatments from that During the time that you were being treated, describe what happened with your health. A. My skin color became a lot clearer, according to 23 my wife now. I didn't have my fuzzy memory but it was going 24 very good. 25 two or three times during that year and a half of treatments I don't think that I was to the doctor or hospital 97 1 that I had. 2 multiple problems. 3 4 5 6 7 8 Q. And previously to and after this, there is And so the doctors office visits, was it just normal yearly visits that you went to? A. No, they were specialty visits regarding my toes and infections in my feet and amputations everywhere else. Q. These were when you weren't treating with Trina, correct? 9 A. That's correct. 10 Q. When you were treating with Trina, did you have 11 12 to go to any of those visits? A. I went to very few. I would say maybe five or six 13 over a year and a half and some of those were just my yearly 14 check-up and they wanted to know my (indiscernible) and find 15 out why I was doing so good. 16 increased -- or decreased every time and my blood sugar was 17 under control. 18 didn't have any problems with my memory. 19 20 21 22 23 24 25 Q. My A1c was a lot better. It I didn't have any problems with my feet. I And were you informed at some point that you could no longer receive treatment at Trina for APT/MII? A. Yes. I was notified around sometime in April that I could not receive treatment any more. Q. What were you told why you couldn't receive the treatment? A. I was told that Blue Cross/Blue Shield after years 98 1 of covering my policy, covering my -- 2 THE COURT: Hold on. Again it's becoming 3 difficult to understand you so I know that this may be hard 4 but you need to speak up and speak clearly so can you begin 5 again on that answer? 6 THE WITNESS: Okay. Could you repeat that please? 7 8 BY MS. MacLEAN: 9 Q. 10 11 12 13 14 15 no longer able to receive treatment? A. I was told that Blue Cross and Blue Shield quit covering this treatment. Q. Did you know Blue Cross had told Trina to tell you they were no longer going to cover it? A. 16 17 What were you told about why the clinic, you were Yes. MR. AUERBACH: I am going to object, your Honor. Hearsay and mischaracterizes the evidence. 18 THE COURT: Sustained. 19 20 BY MS. MacLEAN: 21 Q. Mr. Briggs. 22 A. Yes. 23 Q. Will you please read from petition Exhibit 4-345, 24 what I just put in front of you and sentence that says "we" 25 in the middle of the page. 99 1 THE COURT: Ms. MacLean, I am going to ask you if 2 you would like to refer to that, I will, I don't know if that 3 is an admitted exhibit but if you wanted to offer it, I think 4 the document speaks for itself and I think it's going to be 5 very difficult for the reporter to take this down having the 6 witness read out of the exhibit. 7 exhibits, if you want to lay the foundation and offer it if 8 it's not in; or maybe there is, is there an objection to this 9 particular exhibit? 10 MR. AUERBACH: 11 THE COURT: 12 4. 13 will admit it. 15 Not to the exhibit, no, your Honor. All right. Do you want to offer it? 14 So I am conscious of the MS. MacLEAN: There is no objection to it. petition. THE COURT: 17 note of Exhibit 4 to the petition. 19 I Well, it's Exhibit 4 to the 16 18 So I think this is Exhibit All right. MS. MacLEAN: So I am going to make a Are you offering it? Sure, yes, your Honor, I will offer Exhibit 4 to the petition as Exhibit 2 to this hearing. 20 21 (Hearing Exhibit No. 2 was admitted into 22 evidence.) 23 24 25 THE COURT: All right. And there is no objection so I will admit it and you can refer in argument or briefing 100 1 to that page if you wish, Ms. MacLean. 2 MS. MacLEAN: 3 THE COURT: 4 Okay, your Honor. It's not necessary to have the witness read it to me because I have it right in front of me. 5 MS. MacLEAN: I understand, your Honor. The 6 reason I am bringing this in is because of the directive that 7 is there. And so I guess I didn't -- 8 9 THE COURT: already in. But that's proper for argument. It's It's part of the record so I don't need to have 10 this witness who has been difficult to hear already read it 11 to me. 12 MS. MacLEAN: Okay. 13 14 BY MS. MacLEAN: 15 Q. So do you understand that this letter told Trina 16 Health of Montana that they needed to tell you that you did 17 not have coverage for APT/MII. 18 A. That's correct. 19 Q. After that happened, tell us what happened with 20 your health when you were no longer able to receive regular 21 APT/MII treatments? 22 23 A. About in June, my health started to deteriorate. My memory became bad -- 24 THE COURT: Did you say, "about June"? 25 THE WITNESS: Yeah, it was couple months after the 101 1 treatment. 2 THE COURT: Okay. 3 THE WITNESS: My memory became bad. I began to 4 see -- I got CAT scans and MRIs on my brain to see if there 5 was something and that part is, half of my brain had shrunk 6 from the diabetes. 7 with the possibility of losing one of my toes again. 8 just my overall health, my A1c has gone up a little bit. 9 started to control my blood sugar. I currently have two ulcers on my feet And I I am on a pump and I 10 believe that's my life, is the pump and insulin and I am 11 afraid that if this treatment doesn't get okayed by you, that 12 I am going to end up not lasting very much longer. 13 how much I think about the treatment, you know, to extend my 14 life and I just don't want to believe that. 15 treatments for a year and a half and those were some of the 16 best years that I have had. 17 spiraling downhill. 18 19 THE COURT: Since then, things have been What was the last thing you said? THE WITNESS: I Um, lately my health has been spiraling downhill. 22 THE COURT: 23 THE WITNESS: 24 THE COURT: 25 I had the didn't understand that. 20 21 That's you said. Right, right. From the diabetic things. I just didn't hear the last few words 102 1 2 MS. MacLEAN: I think he said, "spiraling downhill". 3 THE COURT: Okay. 4 THE WITNESS: 5 THE COURT: Thank you. Okay. That's good there. Yes, that's good. 6 7 BY MS. MacLEAN: 8 Q. 9 At this point, are you afraid of losing more toes to amputation? 10 A. Yes, I am. 11 Q. I am going to hand you two photos. 12 Can you tell me what those photos are of? 13 A. These photos are of the wounds that I currently 15 Q. The wounds on your feet currently? 16 A. Yes. 17 Q. Did you ever have any wounds on your feet when 14 18 have. you were treating with Trina? 19 20 21 22 23 24 25 A. I did not have any problems with my feet during Q. Are these the same type of wounds that caused you Trina. to have amputations the last time you had amputations? A. Yes, they are all very similar. MS. MacLEAN: Your Honor, I would like to offer these pictures as Exhibits 3 and 4 to this hearing. 103 1 THE COURT: Are there any objections? 2 MR. AUERBACH: Your Honor, I haven't seen the 3 photos but pending review, other than relevance, I don't have 4 an objection. 5 THE COURT: All right. Thank you. 6 So Exhibits 3 and 4 to the hearing are admitted 7 without objection with the understanding that the defendant 8 has an opportunity to object upon review. 9 10 (Hearing Exhibit Nos. 3 and 4 were admitted into 11 evidence.) 12 13 MS. MacLEAN: Thank you, your Honor. I am just 14 making sure they get to the clerk so they can get to you 15 today. 16 17 BY MS. MacLEAN: 18 Q. 19 So do you, you are a party in this matter, do you understand that, Mr. Briggs. 20 A. Yes, I do. 21 Q. Why are you suing Blue Cross and Blue Shield 22 23 of Montana? A. I am suing Blue Cross/Blue Shield of Montana 24 because for a year and a half, they covered me 100 percent and 25 starting in April, I was notified that I would no longer be 104 1 covered. 2 contractor -- they gave me my policy and it said that these 3 things were covered and how can Blue Cross/Blue Shield come in 4 the middle of a policy and say we are not covering you no 5 more? 6 that and that's not right. 7 And the way I understand contracts -- because I am a And I guess I just don't understand how they can do Q. And Mr. Briggs, do you understand they are saying 8 it's excluded under the policy being investigational, 9 experimental and unproven? 10 A. Yes, I believe that. 11 Q. Do you believe that to be true based upon your 12 13 experience? A. Oh, absolutely not. 14 MR. AUERBACH: 15 THE COURT: Hold tight, hold tight. Sustained. The objection was foundation. 16 objection. Objection, your Honor. Foundation. We have an 17 18 BY MS. MacLEAN: 19 Q. For you, Mr. Briggs, do you believe this 20 treatment is medically necessary for you to not have 21 significant decline? 22 A. This treatment is absolutely necessary to me. 23 I have found out what it was like without it. I found out 24 what it was like using it and for a year and a half, this 25 treatment helped me and helped my diabetes in several, several 105 1 2 different ways. Q. Are there any other treatments that you have been 3 able to obtain in Dillon or even in Montana that kept you 4 from declining with your diabetes? 5 No. I believe Trina is what helps me the most for 6 all that stuff. Of course, I do what the doctors say and keep 7 stuff, you know, bandages and stuff but if I was on treatment, 8 first of all, I don't think I would have this situation and 9 second of all, I feel a lot better when I am on Trina too. 10 A. Q. I notice that you are wearing a boot. Are you 11 talking about the situation, the situation that you have 12 ulcers on your foot that are getting worse? 13 14 15 16 17 18 A. Yes, the ones on my feet, yeah, that are in the, your exhibit. Q. And is Trina the only treatment that's helped make sure that you don't get those ulcers anymore? A. I feel that is my best route and my only route right now. 19 THE WITNESS: And Judge, I am asking you, Judge, 20 please let this continue so many of us people here in Dillon 21 can get some help. 22 23 24 25 BY MS. MacLEAN: Q. I understand that you traveled a couple times to Las Vegas to get treatment between when the clinic closed in 106 1 April and now. 2 A. How many times did you travel to Las Vegas? I traveled to Las Vegas for four treatments. I 3 just can't -- You have to have a number of treatments and but 4 probably I won't be going any more down there because first of 5 all, I can't afford it and second of all, I can't have the 6 treatments right after the other. 7 week. 8 9 10 Q. You have a treatment every So what you are saying is you can't actually maintain a regular schedule of treatment by going out of state? 11 A. No, absolutely not. 12 Q. Is that because you can't afford to do it? 13 A. Um, yeah, that's partial. 14 to have something local here that I can rely on. 15 16 I mean, I'd just like MS. MacLEAN: Your Honor, no further questions at this time. 17 THE COURT: Thank you. 18 Mr. Auerbach. 19 So hang, on hang on, Mr. Briggs. Mr. Auerbach is 20 going ask you questions and I'm going to ask my staff to move 21 the camera so that you can see him. Thank you. 22 23 CROSS-EXAMINATION 24 BY MR. AUERBACH: 25 Q. Good afternoon, Mr. Briggs. I just have a few 107 1 questions for you. I am not sure if I didn't hear you 2 correctly because of the microphone issues, but did you say 3 you received 150 treatments at Trina in Dillon? 4 A. Um, yeah. 5 Q. And that's over the period of October 2015 to 6 7 8 9 10 11 April of 2017; is that right? A. It might be closer to 100. I'm sorry. Probably not 150. Q. How often do you recall going in for a treatment at Trina in Dillon during that 18-month period? A. Um, I would go in twice a day several times -- 12 twice a week several times and then after that, every week, 13 sometimes twice a week if I had a need to. 14 15 16 17 Q. Who decided how often you would go in for treatment during that 18 months? A. Um, I pretty much did because I (indiscernible) all the time. 18 THE COURT REPORTER: 19 THE COURT: 20 didn't hear that. 21 clearly, okay? 22 last question. 23 24 25 I did not hear that answer. Wait, wait, wait, wait, wait. We It's really important to speak slowly and So would you repeat your answer to that THE WITNESS: What was the question again sir? 108 1 BY MR. AUERBACH: 2 Q. 3 The question was who decided how often you would come in to Trina Health in Dillon for treatment? 4 A. It was mostly my call. 5 Q. Did you receive advice from a doctor or nurse 6 practitioner on how often you should come in for treatment? 7 A. Um, yes. 8 Q. But ultimately you were the one that decided? 9 A. Pardon? 10 Q. Ultimately you -- 11 A. I was the one that decided, yes. 12 Q. Was there any limitation on the number of times 13 you could come in for treatment, according to the Trina 14 Clinic providers? 15 16 17 18 19 20 21 A. I don't know. I think I only did it once or twice Q. Since April of 2017, have you had any other a week. treatments specific to your diabetes and your insulin? A. Nothing different. I use a lot of medication but never one type (indiscernible) for multiple years. Q. So the treatments you have been getting for 22 you're your diabetes since April of 2017 is the same as what 23 you got prior to October of 2015? 24 A. The same treatment from Trina? 25 Q. Do you see an endocrinologist? 109 1 2 THE COURT: question. 3 4 I don't think he answered the He asked a question. MR. AUERBACH: Oh, sorry. I thought you said, "yes". 5 THE COURT: He is asking you if you are getting 6 right now the same treatment that you got before you started 7 with Trina in 2015. Is that right? 8 MR. AUERBACH: 9 THE WITNESS: 10 THE COURT: Yes. Yes, I am doing the same treatment. Okay. Thank you. 11 12 BY MR. AUERBACH: 13 Q. 14 And Mr. Briggs, did you see an endocrinologist to consult with about your diabetes? 15 A. No, I do not. 16 Q. Do you see any other medical specialist for your 17 diabetes? 18 A. 19 20 21 wounds. I see an orthopedic surgeon. Other than that, no. MR. AUERBACH: THE COURT: 23 MS. MacLEAN: 25 Thank you, Mr. Briggs. other questions at this time. 22 24 He takes care of my Thank you. Ms. MacLean? Redirect, your Honor. I have no 110 1 REDIRECT EXAMINATION 2 BY MS. MacLEAN: 3 Q. 4 Mr. Briggs, did you have to see a nurse practitioner every time you went in to Trina? 5 A. Yes, there was always on staff. 6 Q. And they did limit the amount of times you could 7 come in, would it be correct, to no more than two? 8 A. That's correct. 9 Q. And most times, you only went in once a week, 10 correct? 11 A. That is correct. 12 Q. And that was on the advice of the nurse 13 practitioner there? 14 A. That's correct. 15 Q. But you decided whether or not you actually 16 wanted to go during that treatment schedule set for you, 17 correct? 18 A. That's correct. 19 Q. And you were asked whether or not there were 20 other specialists that you saw here in Dillon. 21 specialists that you can see here regarding your diabetes 22 here in Dillon? 23 A. 24 25 Are there any Just my family doctor that's treated my diabetes for the last 15 years. Q. Has that diabetes treatment kept you from getting 111 1 sores on your feet and kept you from getting amputations? 2 A. No, it has not. 3 Q. Has your primary care physician sent you to any 4 5 other specialists? A. No, they have not. 6 MS. MacLEAN: 7 THE COURT: 8 Any cross? 9 MR. AUERBACH: 10 11 THE COURT: No more questions, your Honor. Thank you. Nothing further. Thank you. witness. 12 (Witness excused.) 13 MS. MacLEAN: 14 THE COURT: 16 MS. MacLEAN: 18 Your Honor, I call Harold Grogan to the stand. 15 17 You may call your next Harold Grogan. The plaintiffs, the plaintiffs call Harold Grogan to the stand. THE COURT: And I was just trying to repeat it 19 because that was not very easy to understand and I am trying 20 to make sure our court reporter can get it. You may proceed. 21 22 HAROLD GROGAN, 23 called as a witness, and having been first duly sworn, was 24 examined and testified as follows: 25 112 1 DIRECT EXAMINATION 2 BY MS. MacLEAN: 3 Q. Please state your name. 4 A. Harold Grogan. 5 Q. Where do you reside, Mr. Grogan? 6 A. Dillon, Montana. 7 Q. Please speak into the microphone. 8 A. Dillon, Montana. 9 Q. And what do you do for a living? 10 A. Self-employed. 11 I've been doing that for signs and engraving. 12 13 I do custom work. THE COURT: I'm sorry. I didn't understand that. I didn't understand. I'm sorry, For signs? 14 MS. MacLEAN: Speak up. 15 THE WITNESS: Signs and engraving. 16 THE COURT: If you can, sir, I know that you are 17 probably nervous but if you can speak up loudly, as loudly as 18 you can and speak slowly, that would be very helpful to us. 19 20 BY MS. MacLEAN: 21 Q. 22 Were you covered by a policy that was a Blue Cross/Blue Shield Montana policy as of 2015? 23 A. Yes. 24 Q. And who owned that policy? 25 A. Joan Grogan. 113 1 Q. Is that your wife? 2 A. Yes. 3 4 THE COURT: "Joan" or "John"? Did you say -- Excuse me. Did you say I didn't, I couldn't hear that word. 5 THE WITNESS: 6 THE COURT: Joan. Okay. Thank you. 7 8 BY MS. MacLEAN: 9 Q. 10 And the two of you are covered under the same policy? 11 A. Yes. 12 Q. Is that the same policy you were covered under in 13 2017 from Blue Cross/Blue Shield of Montana? 14 A. Yes. 15 Q. Do you have the same coverage now? 16 A. I believe so. 17 Q. Do you have diabetes? 18 A. Yes. 19 Q. How long have you had diabetes? 20 A. Since 2009. 21 22 THE COURT: Hang on one minute. that right? 23 MS. MacLEAN: 24 THE COURT: 25 He said 2009; is Yes. Okay. Thank you. difficult for the court reporter to hear. It's just real 114 1 BY MS. MacLEAN: 2 Q. 3 Do you remember signing affidavits that were filed with this court? 4 A. I do. 5 Q. Do you remember the affidavit that you filed on 6 October 30th, 2017? 7 A. I do. 8 Q. And do you remember a supplemental affidavit that 9 you filed on January 23, 2018? 10 A. I do. 11 Q. What was the purpose of you doing those 12 13 affidavits? A. 14 Trying to get Trina to continue their treatments. THE COURT: I couldn't understand. Ms. MacLean, I 15 couldn't understand that. 16 understand your question but we couldn't hear the answer. 17 18 THE WITNESS: Could you try it again? I could To get Trina to start paying the treatments again. 19 THE COURT: To start -- 20 21 BY MS. MacLEAN: 22 Q. 23 24 25 (Indiscernible) the restraining order? THE COURT: Hang on. 'To get Trina to start treating us again', is that what you said, sir? THE WITNESS: Yes. 115 1 THE COURT: Okay. Thank you. 2 3 BY MS. MacLEAN: 4 Q. 5 Let's take a look at your affidavit that you did on October 23rd, 2017. What type diabetes do you have? 6 A. Type 2 diabetes. 7 Q. And how old are you? 8 A. Sixty. 9 Q. And tell me the issues that you faced prior to 10 11 treating with Trina that resulted from your diabetes. A. Neuropathy, I could hardly walk at times. I had 12 several gastrointestinal attacks that sent me to the hospital 13 to ICU and life-flighted to Missoula. 14 several issues relating to diabetes. 15 16 17 Q. And balance issues, How did you come to find out about the APT/MII treatment that Trina was providing here? A. I knew Ron and saw how Trina was working for him, 18 knew how bad he looked before he went down to Scottsdale and 19 had treatments and saw that he was getting the clinic started 20 here in Dillon. 21 22 Q. And did you then seek out the treatment when the clinic opened? 23 A. Yes. 24 Q. What was your experience with the clinic? 25 A. It improved my health in multiple ways. I had no 116 1 gastrointestinal issues during the treatments. 2 balance was better like going down the stairs without having 3 to hang onto the handrail. 4 retreat to where I didn't have the extreme pain so I could 5 walk on my feet all the times skin and skin color come back 6 from whitish to a more pink color. 7 Q. I had, my My neuropathy is in, was in Did any of the treatments that you had received 8 in Dillon or anywhere else in Montana provide you the same 9 relief from this pain and this gastrointestinal neuropathy 10 that took you into the ICU? 11 A. No. 12 Q. Did you have any significant issues with your 13 14 health when you were treating with Trina APT/MII treatment? A. 15 16 I received mighty improvements. THE COURT: I didn't understand that. Would you repeat that? 17 18 None. THE WITNESS: I received, I had improvements in my health during treatments. 19 THE COURT: Thank you. 20 21 BY MS. MacLEAN: 22 Q. Did you have any need to seek out additional 23 specialists or physicians or anything during the time that 24 you were treating? 25 A. None. 117 1 Q. And did you start treating from, in 2015? 2 A. Yes, I did. 3 Q. And did that go until the Trina Clinic closed in 4 April of 2017? 5 A. Yes. 6 Q. How did you find out that the clinic closed? 7 A. (Indiscernible) Trina. 8 9 THE COURT: I'm sorry. THE WITNESS: 11 THE COURT: 12 THE WITNESS: The people at Trina called me. Okay. And what did they tell you? They said Blue Cross/Blue Shield was no longer covering. 14 THE COURT: 15 THE WITNESS: 16 Blue Cross/Blue Shield was not what? Would not cover the treatment no more. 17 THE COURT: Okay. Thank you. 18 19 BY MS. MacLEAN: 20 Q. 21 Did you understand that's what Blue Cross/ Blue Shield had told them at that time? 22 MR. AUERBACH: 23 THE COURT: 24 THE WITNESS: 25 I didn't understand that, Ms. MacLean. 10 13 I didn't hear that. Objection. Hearsay. Sustained. To me, it said that they had a change of heart that they weren't going to cover our 118 1 treatments anymore. 2 3 BY MS. MacLEAN: 4 Q. 5 Do you understand that you're a plaintiff in this matter? 6 A. Yes. 7 Q. And that you understand that you are suing 8 Blue Cross/Blue Shield? 9 A. Yes. 10 Q. And why you suing Blue Cross/Blue Shield 11 12 of Montana? A. Blue Cross/Blue Shield so we could continue having 13 our treatments that they said we could have when we first 14 started. 15 16 Q. And those are the treatments that you believe were covered under your patient policy? 17 A. Yes. 18 Q. Or I should say under your Blue Cross/Blue Shield 19 of Montana policy? 20 A. Yes. 21 Q. Okay. 22 23 24 25 Why are you here today seeking for Trina to be allowed to be reopened to treat you? A. So I can, so that my health can start returning to a better productive self. Q. So at this time, what issues have you seen that 119 1 make you concerned that you are not going to be, that you are 2 going to suffer irreparable harm? 3 A. My gastrointestinal problems are coming back and 4 are getting worse. 5 they have been close and I do know my balance problems are 6 coming back. 7 it's a downhill spiral I am going on right now. 8 9 Excuse me. Did you say your bowels problem is coming back? THE WITNESS: My gastrointestinal problems are coming back. 12 13 My neuropathy pain is coming back so it's just THE COURT: 10 11 They have not sent me to the ER yet but THE COURT: Okay. You didn't say, "bowels"? I didn't hear the other word. 14 MS. MacLEAN: He said, "balance". 15 THE WITNESS: Balance. 16 THE COURT: Balance. Thank you. 17 18 19 20 BY MS. MacLEAN: Q. When you, the last time you saw these issues at the point they are now, what happened next. 21 A. What do you mean by that? 22 Q. What happened after the last time you were this 23 24 25 bad with your gastrointestinal issues and your neuropathy? A. Well, the neuropathy gets to where I cannot walk on my feet at times. And the gastrointestinal problems, they 120 1 sent me to the ER highly dehydrated and stuff. 2 they determine it's bad enough, they will ship me out of here 3 back to Missoula again and I will be in ICU for a while, come 4 back into the hospital for a few days. 5 6 Q. And if it's, Did any physician indicate to you what could result from these gastrointestinal issues? 7 A. The gastrointestinal issues could take my life. 8 Q. Are you afraid that you are going to die if you 9 do not get this treatment? 10 A. I believe I could, will. 11 Q. Would you repeat that? 12 A. I believe I will without the treatment. 13 14 THE COURT: said. 15 16 THE WITNESS: I believe that without this treatment, I could die (indiscernible). 17 THE COURT: 18 Could you try it again? 19 loudly. 20 21 I didn't hear the last part of what he Sorry. I am just not getting it. You need to really speak clearly and THE WITNESS: I believe I could die without this treatment. 22 THE COURT: Thank you. 23 24 BY MS. MacLEAN: 25 Q. Is that why you are here seeking this preliminary 121 1 injunction? 2 A. Yes. 3 Q. Do you believe that you will suffer irreparable 4 harm if it does not, if it's not put in place? 5 A. Yes. 6 Q. Will you confirm that your policy that you are 7 covered under is Exhibit 3 to the petition that you filed, 8 the Blue Cross policy? 9 10 A. Yes, that's my policy. MS. MacLEAN: Your Honor, I don't have any further 11 questions on the record right now. 12 THE COURT: 13 Mr. Auerbach? 14 MR. AUERBACH: 15 Thank you. Your Honor, we have no questions for Mr. Grogan. 16 THE COURT: Thank you. 17 Thank you for your testimony, sir. 18 (Witness excused.) 19 THE COURT: 20 (Off the record.) 21 MS. MacLEAN: Mr. Grogan is excused. Are you going to now call Dr. Elliott? Your Honor, we were going to call 22 Joan Grogan but I think that her testimony would probably 23 just cover exactly what Mr. Grogan's testimony covered so 24 yes, your Honor, we can go to Dr. Elliott's testimony. 25 THE COURT: All right. Thank you. And what I am 122 1 going to ask you to do, Ms. MacLean, is focus, I know there 2 is probably A days' worth of testimony in Dr. Elliott on 3 substance. Are you hearing me okay? 4 MS. MacLEAN: 5 THE COURT: Yes, your Honor. So I want to you focus him on the 6 things that I need to decide today, which is that the 7 applicants are entitled to the relief demanded, that it 8 appears that the commission or continuance of some act would 9 produce greater irreparable injury, and I am summarizing, 10 that there is some violation that the Blue Cross/Blue Shield 11 is doing or threatening to do which violates the applicant's 12 rights or that the adverse party Blue Cross/Blue Shield 13 during the pendency of this action threatens to do or is 14 about to remove or dispose of the adverse parties' property 15 with intent to defraud and any other factors that relate to 16 the issue that we are here about today. 17 that that's a tough order but I want you to focus on that for 18 this hearing. 19 20 21 MS. MacLEAN: And I understand Your Honor, I do understand that and I am trying to do that but -THE COURT: I know you are; I know you are. And 22 I understand you have got a challenge and I just want to ask 23 you as best you can to narrow the testimony today from 24 Dr. Elliott to that. 25 MS. MacLEAN: Yes, your Honor. 123 1 2 Dr. Elliott, will you please state your -- Oh, do you want to swear him in? 3 THE COURT: Yes. Thank you. 4 5 JOHN PALMER ELLIOTT, 6 called as a witness, and having been first duly sworn, was 7 examined and testified as follows: 8 9 THE COURT: 10 11 Thank you. MS. MacLEAN: Your Honor, I am going to resituate so that I can sit where I was sitting before. 12 THE COURT: Okay. And to the extent that you want 13 to have him endorse what he has already said in his 14 affidavit, it is not necessary to then go through the 15 affidavit. I can take note of that and that is adequate. 16 17 DIRECT EXAMINATION 18 BY MS. MacLEAN: 19 Q. 20 your affidavit? 21 A. Yes, ma'am. 22 Q. Do you have that in front of you? 23 A. I do. 24 25 Dr. Elliott, do you remember what you stated in MS. MacLEAN: And your Honor, if you will take note of everything that was in Dr. Elliott's affidavit as of 124 1 January 23, 2018. 2 THE COURT: Yes, I will do that. 3 MS. MacLEAN: 4 THE COURT: 5 That is Docket No. 39. I am looking for the docket number. That's the supplemental affidavit. 6 MS. MacLEAN: 7 THE COURT: 8 I offer that up. He only had one affidavit. In the docket it's called supplemental so I apologize. 9 MS. MacLEAN: I understand. 10 11 (Hearing Exhibit No. 5 was admitted into 12 evidence.) 13 14 BY MS. MacLEAN: 15 Q. Please state your name, Dr. Elliott? 16 A. John Palmer Elliott. 17 Q. And what do you do for a living? 18 A. I am a physician. 19 Q. Could you state your educational background for 20 21 me please? A. Sure. I went to college at Wesleyan University in 22 Middletown, Connecticut. I went to medical school and 23 received my M.D. or Medical Doctor degree from the 24 University of Colorado in Denver, Colorado. 25 school, I entered -- Actually, during medical school, I Following medical 125 1 entered the Armed Services of the United States and joined the 2 United States Army. 3 Army Medical Center in Honolulu, Hawaii that consisted of four 4 months of internal medicine, four months of surgery, two 5 months of pediatrics and two months of OB-GYN. 6 I did a rotating internship in Tripler During that time, I made a decision to enter 7 OB-GYN as my life career. I took a residency in the United 8 States Army in obstetrics and gynecology at Fitzsimons Army 9 Medical Center in Denver, Colorado. Two years after finishing 10 my residency, I took a fellowship, which is kind of an 11 advanced degree of training in what is called maternal fetal 12 medicine or high-risk obstetrics. 13 14 Q. And have you testified as a medical expert before? 15 A. Yes, ma'am. 16 Q. How many times? 17 A. I have reviewed probably over 600 cases for both 18 plaintiff and defense involving obstetrical issues. 19 testified by deposition about 250 times. 20 trial close to 100 times. 21 22 Q. 25 I have testified at And do you know what giving an opinion to a degree of reasonable medical certainty means? 23 24 I have A. Yes, I do that every time I do medical legal work, Q. And for any reason you are not doing so today, yes. 126 1 will you let me know? 2 A. Yes, I will. 3 Q. Otherwise, we can agree that everything you are 4 saying is to a reasonable medical certainty? 5 A. Yes. 6 Q. Are there other areas of medical practice in 7 which you work now? 8 A. Yes, there are. 9 Q. What are those? 10 A. I am the Medical Director of Trina Health AZ, 11 Trina Health Arizona. 12 four years. 13 14 15 Q. I have held that position for the last How did it come about that you held that medical directorship? A. I -- That it's a great question. My nurse, who 16 was my diabetes educator for our pregnant patients, we have -- 17 Probably about 20 percent of our practice consists of diabetic 18 patients who happen to be pregnant. 19 practitioner; well, she is a nurse practitioner. 20 nurse practitioner at a Trina Clinic a number of years before 21 she moved to Arizona and she would tell me about the patients 22 that she helped to treat in this clinic. 23 fascinating to me that it didn't make any sense medically that 24 this treatment would, would reverse the end organ damage of 25 diabetes. My nurse had been a nurse She was a And it was, I guess, But I am a scientist and I just happen to be an 127 1 OB-GYN and a maternal fetal medicine specialist and my -- 2 Frankly, my dad was a diabetic, suffered many of the 3 complications that were spoken to by the other people this 4 afternoon -- 5 THE COURT: Ms. MacLean, I apologize, Doctor, but 6 this is a narrative response and I am really going to ask you 7 to focus this down. 8 9 THE WITNESS: I think, let me do that. Based on a visit to a Trina Clinic in California, the stories that we 10 elicited from the patients were just like the ones that you 11 heard today. 12 seen by these patients when they started the Trina treatment. 13 It was not seen by all the treatment that they had prior and 14 as a benefit to mankind, we felt that we should, since I had 15 the expertise of my nurse practitioner, that we should come 16 back to Arizona and open a clinic and offer this therapy to 17 diabetic patients. This was unbelievable, the benefit that was 18 19 BY MS. MacLEAN: 20 Q. And this was over four years ago? 21 A. Yes. 22 Q. So I am going to ask you to tell me less about We opened our doors January 1st of 2013. 23 your experience and more about the science a little bit for 24 the Court so you can talk about some of the questions I am 25 going to ask you in a minute. Can you tell us what the 128 1 Artificial Pancreas Treatment, the Microburst Insulin 2 Infusion, APT/MII, does? 3 A. Yes. We have, basically what happens, in a normal 4 patient, the pancreas in response to a meal, glucose is 5 ingested in carbohydrates in various forms. 6 the pancreas to release insulin. 7 microbursts basically every six minutes. 8 insulin that is released by the pancreas. 9 into the portal vein and that travels directly to the liver so That stimulates That insulin is released in There is a burst of That goes directly 10 insulin and glucose are provided to the liver, which is the 11 fuel to allow the liver to produce enzymes. 12 34 different enzymes that the liver produces, all of them are 13 regulating metabolic processes in the body and so the liver 14 releases its enzymes and it then allows every cell in the body 15 to basically take insulin and glucose and make energy. 16 is called APT and that's what the cell uses to do its 17 function, whether it's a kidney cell, a brain cell, a skin 18 cell or any cell. 19 normal pancreas. That is how APT works. There are Energy It mimics the 20 So what happens with APT is that, that glucose is 21 administered in a dose that is calculated based on the weight 22 of the patient and that dose is equal to about two meals so 23 the calories in the glucose that are administered would 24 represent two meals for the patient so based on -- 25 THE COURT: Excuse me, excuse me, Doctor. Excuse 129 1 me, Doctor. I apologize for interrupting but Ms. MacLean, I 2 am not going to be able to absorb all of this science. 3 think what I need to do is get to the extent that Dr. Elliott 4 on this particular issue has some science to offer me. 5 I am interested in is whether or not this is peer-reviewed 6 and whether or not it's accepted in the scientific and 7 medical community. 8 obviously, there is going to be more time expended on this 9 but I want to focus on that piece right now because I think, I What Assuming we get to another hearing, 10 to the extent it's relevant to this issue today, the question 11 is whether or not it's experimental or investigative and I am 12 not even sure that I will get there today but that's the only 13 thing that I am interested in at this point at least. 14 MS. MacLEAN: Your Honor, what Dr. Elliott is 15 going to also is whether or not it's substantially similar or 16 substantially different than the OIVIT Treatment process and 17 that's why I am -- What he is describing is what's different 18 from that process. 19 THE COURT: Well, right now he is just describing 20 the way the body ordinarily handles glucose and I understand 21 that, and the insulin. 22 of it. I need him to just get to the crux 23 24 BY MS. MacLEAN: 25 Q. Okay. Dr. Elliott, have you written any 130 1 publications that are peer-reviewed publications that cover 2 the fact that this is not an experimental, investigational or 3 unproven treatment. 4 A. Yes, I have. 5 Q. And was that, was that provided, was that 6 provided for, from your knowledge, to Blue Cross/Blue Shield 7 of Montana? 8 9 10 11 A. I believe, yes, that you provided it in one of your letters in exchanges with Blue Cross attorneys. Q. Did you have a chance to review the Petition in this matter and all of the exhibits to that petition? 12 A. Yes, I did. 13 Q. And what you are talking about, I believe, is do 14 you have in front of you Exhibit 7? 15 THE COURT: Do you see Exhibit 7? And Ms. MacLean, so you know, I have 16 read Exhibit 7. 17 objection or not from Blue Cross/Blue Shield. 18 19 20 If you are going to offer it, we can get an MS. MacLEAN: Your Honor, I offer all of the exhibits to the petition. THE COURT: All right. 21 to respond to that offer? 22 MR. AUERBACH: Mr. Auerbach, do you want I don't have an objection to them 23 so long as there is some foundation laid for the testimony 24 about the exhibits. 25 THE COURT: All right. What I am trying to 131 1 do is -- 2 MR. AUERBACH: 3 THE COURT: No objection, your Honor. All right. So we are talking about 4 Exhibit 7. I understand you are offering all of the 5 exhibits, which is Exhibits 1 through 10? 6 MS. MacLEAN: 7 THE COURT: Yes, your Honor. So what I am trying to do, as I 8 understand it, Mr. Auerbach is not objecting to Exhibits 1 9 through 10 of the petition so they are in. 10 11 So again, I have read it and I don't want you to have the witness read it to me. 12 MS. MacLEAN: All right? Yes, your Honor. 13 14 (Petition Exhibit Nos. 1 - 10 were admitted into 15 evidence.) 16 17 BY MS. MacLEAN: 18 Q. Do you see, Dr. Elliott, that attached to that 19 letter is this article that you wrote as Petition Exhibit 20 Bates No. 7-436. 21 A. 22 Yes. THE COURT: I have read that article. 23 24 BY MS. MacLEAN: 25 Q. What brought about your writing of this article, 132 1 Dr. Elliott? 2 3 THE COURT: didn't hear that question. 4 5 Ms. MacLean, sorry. MS. MacLEAN: Ms. MacLean, we Sorry. I want Dr. Elliott to explain why this article was written, this peer-reviewed article. 6 THE COURT: Okay. 7 THE WITNESS: Thanks. Since we started doing the Trina 8 treatment in Arizona, I have been looking for data and the 9 ability to publish our results there. They are so 10 startlingly good that again, I am a scientist and I want to 11 share that with the scientific community. 12 opportunity to collect these data and so I was the first to 13 author. We had the 14 15 BY MS. MacLEAN: 16 Q. 17 18 And how many other peers have reviewed this article? A. Well, I don't know. The journal selects the peers 19 to review the article. 20 reviewers, usually three reviewers who judge the scientific 21 merit and if it, if it meets scientific merit, it gets 22 selected for publication. 23 24 25 Q. We submitted and the journal has If it does not, it gets rejected. Were there other physicians who participated in helping you write this article? A. Yes. There were other physicians that are listed 133 1 in the list of authors. 2 nurse practitioners. 3 Q. Some were physicians and some were And those were the names that are listed on the 4 right-hand corner under Volume 4, Issue 4, 2017 on the front 5 page of this article? 6 7 8 9 A. Yes. They are not all physicians or nurse practitioners but most of them are. Q. And so if you could please take a look at the policy that was -- Do you remember the cease and desist 10 letter that was attached to the letter that I sent on 11 July 28, 2017 as Exhibit Bates No. 7-418? 12 A. I have got that, yes. 13 Q. And you have reviewed this letter -- 14 A. Yes. 15 Q. -- that was from Blue Cross/Blue Shield of 16 Montana to Trina? 17 A. Yes. 18 Q. And actually I think, the name on this particular 19 letter is Kimberly Leighton, correct? 20 A. It is. 21 Q. Have you reviewed all of the cease and desist 22 letters that were sent to Blue Cross/Blue Shield of Montana 23 that were sent to Trina by Blue Cross/Blue Shield of Montana 24 on that same day? 25 A. Yes. They are all the same. 134 1 Q. They are all the same with the same content? 2 A. Yes. 3 Q. And do you see the conclusions on Page 2 that are 4 reached in the very first paragraph under the box there that 5 refers to medical policy 201.028? 6 A. Yes. 7 Q. And that medical policy is also attached to the 8 cease and desist letter. Do you see that? 9 A. Yes. 10 Q. Do you see that in this letter, 11 Blue Cross/Blue Shield of Montana is trying to say that 12 APT/MII is the same as CIIIT as defined in this policy? 13 A. Yes, they are. 14 Q. And is that correct? 15 A. It is not correct. 16 Q. Why, why not? 17 A. They are totally different therapies. CIIIT was 18 an early therapy that used entirely different methodology in 19 which insulin was given in ever-increasing doses and then 20 glucose was given basically as the patient felt like she 21 needed or he needed to cover their low blood sugar when they 22 started to get symptoms. 23 MII Therapy is totally different. 24 the pumps are not the same. 25 CIIIT could not do MII. First of all, The pump that was used in the So the older therapy could not be 135 1 done with the pump that is used for Artificial Pancreas 2 Therapy MII so it's a totally different pump. 3 at the pump for Artificial Pancreas Therapy, it delivers 4 insulin in response to a glucose load and it is, it is a 5 physiologic treatment as opposed to the unphysiologic 6 treatment of CIIIT so the results of CIIIT proved that it was 7 unphysiologic and the results of MII proved that it is 8 physiologic so they are not the same therapy. 9 any unbiased scientist would say they are not the same 10 11 And if you look Very clearly, therapy. Q. And so the therapy that is described in this 12 medical policy that was sent is not APT/MII Treatment, 13 correct? 14 A. It is absolutely not. 15 Q. And it is not substantially similar to APT/MII 16 17 18 19 Treatment, correct? A. The only similarity is that insulin is used. Otherwise, they are not similar in any respect. Q. You had an analogy for that. You told me that 20 was regarding the way that chemotherapies could be related to 21 one another that would be similar to the way they are 22 substantially different? 23 A. Yeah. When I looked at this, I felt that the same 24 kind of thing would be if you took a class of drugs like 25 chemotherapy and then just basically said they were all 136 1 similar. 2 similar so different therapies have different characteristics. 3 And in this case, that's exactly true, that MII is not similar 4 in how it acts and how the results are to CIIIT. 5 Q. Well, they all do treat cancer but they are not Do you see, if you go to the medical policy at 6 Petition Exhibit 7-421, it says that CIIIT is considered 7 experimental, investigational and or unproven. 8 that? 9 A. Yes, ma'am. 10 Q. Do you understand that that's where Do you see 11 Blue Cross/Blue Shield is saying APT/MII is experimental, 12 investigationally or unproven because it's CIIIT? 13 A. Yes, that's what they are trying to say. 14 Q. Is that correct? 15 A. No, it is not correct at all. Certainly, I agree 16 that CIIIT or OIVIT, was experimental. 17 investigated with an IRB and with consent from the patients. 18 That is not true for the MII Artificial Pancreas Treatment. 19 Q. It was, it was And do you see the rationale on, it's actually 20 Page 3 of this policy but you can see it at 21 Petition Exhibit 7-423? 22 bold? It says "rationale" in big font, 23 A. Yes. 24 Q. Do you see where it says, "no study --" and this 25 is at the bottom of the reverse paragraph under, "rationale", 137 1 "no studies were identified that investigate the proposed 2 mechanism of action of CIIIT in humans". Do you see that? 3 A. Yes. 4 Q. Is this true as to APT/MII? 5 A. No, it is not. 6 Q. Are there studies that have investigated the 7 8 proposed mechanism of action of APT/MII in humans? A. Yes. The study that I was the first author on 9 investigated that and clearly demonstrated that there was a 10 switch in these patients that were receiving MII Therapy, a 11 switch from lipid metabolism, which is very harmful to the 12 body and which results in the morbilities that happen with 13 diabetes. 14 significant switch to carbohydrate metabolism, which is what 15 the normal body does. 16 elucidated in the first part of the study that was published 17 in 2017. 18 Q. There was a very clear and statistically So the mechanism of action was So the rationale and description of the treatment 19 that are contained in this medical policy that the cease and 20 desist letter was based upon are completely inappropriate for 21 APT/MII? 22 A. Totally inappropriate. 23 Q. And is anything in this medical policy that makes 24 25 APT/MII substantially similar to CIIIT? MR. AUERBACH: Your Honor, I have been trying to 138 1 bite my tongue but -- 2 3 THE COURT: Hold tight, hold tight. objection. 4 MR. AUERBACH: Ms. MacLean has been testifying all 5 day when it comes to offering expert testimony. 6 the witness should -- 7 8 THE COURT: Yes, sustained. MS. MacLEAN: You have been leading I'm sorry, your Honor. I have been trying to speed it along so I'm so sorry. 11 THE COURT: 12 MS. MacLEAN: 13 I believe so I am hoping you are getting closer. 9 10 We have an Understood. I will try not to but I am just trying to speed it along as you have asked. 14 THE COURT: I appreciate, I appreciate that and I 15 do want to ask, as long as we have this short moment, what 16 are you looking at in terms of time? 17 MS. MacLEAN: 18 We are making some good progress, your Honor. 19 THE COURT: Well -- 20 MS. MacLEAN: 21 THE COURT: I am not sure. I am looking at 4:25 and like I said, 22 we are going to stop this at 5 so what is your thinking now 23 that I have said that? 24 25 MS. MacLEAN: I think I will be done with this witness in 20 minutes, your Honor. 139 1 2 THE COURT: All right. I think we are going to have to stop for a minute and talk about logistics then. 3 Because you have witnesses; is that right? 4 MR. AUERBACH: 5 THE COURT: Yeah. All right. So here is what I have, 6 here is what I have. I have a completely full day tomorrow 7 with youth in need of care, which is a statutory priority. 8 have a sentencing on a homicide on Friday morning that will 9 take the entire morning. I I can block out -- and I have to be 10 done -- I can block out Friday afternoon. I know everyone is 11 inconvenienced but this is sort of the nature of this beast. 12 So let me start with you, Ms. MacLean, I will let 13 you keep going to 5 but I just want to solve these logistical 14 issue now. 15 starting at 1? 16 So what are your thoughts about Friday afternoon MS. MacLEAN: Your Honor, my husband is out of 17 town for a military assignment and my kids are off of school 18 on Friday so I will have to find somebody to watch them. 19 It's going to be difficult for me to do. 20 THE COURT: I understand. And I know that it's 21 inconvenient but I can't make people go past 5 and it's clear 22 that we are going past 5 today and this is an injunction that 23 has, also has statutory priorities so that's my option. 24 start again next week with the same kind of crammed calendar. 25 MS. MacLEAN: I Your Honor, I will make it work. 140 1 2 THE COURT: inconveniencing you. 3 4 Okay. And I apologize for I am not trying to. And as for the defendant, what is your thought? MR. AUERBACH: 6 (Off the record.) 7 MS. MacLEAN: Do you mind if we just look? Dr. Elliott, if we need you, are you available on Friday afternoon? 9 THE WITNESS: 10 THE COURT: I will make myself available, yes. Thank you. And they are just 11 consulting with their witnesses, Ms. MacLean. 12 just a moment. 13 14 MS. BEATTY: THE COURT: have to drive back. 17 18 I think Friday afternoon would work All right. Thank you and I know you Thank you, Ms. Beatty. MR. AUERBACH: It is Ground Hog Day on Friday, by the way, your Honor, just so you know. 19 20 It should be for us. 15 16 I know you are looking at -- 5 8 Thank you. THE COURT: All right. It is Ground Hog Day on Friday, I am told, so we are hoping for -- 21 MS. MacLEAN: And your Honor, may I make a motion 22 to allow Taylor Romine to be permitted to testify at the 23 hearing by VisionNet like Dr. Elliott is now? 24 the courtroom right now but she has to go back to where she 25 came from. She is here in 141 1 THE COURT: Where did she come from? 2 MS. MacLEAN: She came from Salt Lake. 3 DR. ELLIOTT: Your Honor, would it help if I just 4 testify on Friday and other witnesses could testify today, 5 that are present? 6 THE COURT: What are your thoughts? 7 MR. AUERBACH: I have no problem with her 8 testifying. 9 telephonically on Friday if the Court is okay with it. 10 11 We have no issue with her testifying It seems -THE COURT: I will tell you what my view is about 12 all this technology. It's a nightmare. So I am not sure we 13 could get both Dr. Elliott on the screen and Taylor, I can't 14 recall her last name but I can't get them both on the screen 15 at the same time. 16 with Dr. Elliott on Friday and Ms. Amine, I believe. So the question is, I guess, finishing up 17 MS. MacLEAN: 18 THE COURT: 19 MS. MacLEAN: Romine. Romine, excuse me. Your Honor, I could come to 20 Great Falls. 21 come to Great Falls on Friday and she could testify by phone 22 in your courtroom so we don't have three locations going, if 23 that works for you. 24 25 I am in Helena; that's where I live. THE COURT: That would be fine. I could And then what I would have her do rather than by phone is do it using either 142 1 VisionNet, which would be preferred. 2 or where does she live? 3 MS. MacLEAN: 4 THE COURT: No. Is she in Dillon then She lives in Salt Lake. In Salt Lake so it would have to be 5 over the Real Presence app, which sometimes works and 6 sometimes doesn't. 7 possibly do it with her so that's going to be the trick. 8 9 So that would be the only way we would MS. MacLEAN: And co-counsel Laurie Zmrzel has to fly back also to California. She wants to know if it's okay 10 if she is excused for the remainder of this hearing on 11 Friday. 12 13 THE COURT: does not object so that's fine. 14 15 That's fine with me and the defendant MS. MacLEAN: You are excused. Is it okay if I finish up with Dr. Elliott? 16 THE COURT: Yes, that's fine. Thank you. 17 18 BY MS. MacLEAN: 19 Q. Thank you. So I am back at the medical policy, 20 Dr. Elliott, and the medical policy on page, on Petition 21 Exhibit 7-426. 22 beyond where we are looking at? Do you see that, which is a couple pages 23 A. Yes. 24 Q. Do you see where it talks about the coding of the 25 HCPCS code G9147 under "coding"? 143 1 A. Yes. 2 Q. Do you recognize that code? 3 A. Do I recognize it? 4 Q. Are you familiar with OIVIT, Outpatient 5 No, I don't. Intravenous Insulin Treatment? 6 A. Yes, I am. 7 Q. And if you take a look at the cease and desist 8 letter and you go to the second page of that cease and desist 9 letter, do you see -- 10 A. What exhibit please? 11 Q. The second page of the cease and desist letter 12 where it says the 2017 HCPCS Level II Manual lists HCPCS 13 G9147 as Outpatient Intravenous Insulin Treatment. 14 A. You are going to have to point me to the page 16 Q. So Petition Exhibit 7-419. 17 A. Okay. 18 Q. Do you see on the second paragraph down, the part 15 19 here. Let me get back there. Okay, got that. that I just read about the HCPCS code and the G9147? 20 A. I do, yes. 21 Q. Do you see where it says that it is Outpatient 22 Intravenous Insulin Treatment? 23 A. Yes, I do. 24 Q. Are you familiar with that treatment? 25 A. No, I am not. I have never, no, I am not familiar 144 1 with it. 2 never been done in our clinic. 3 I mean I have read about it. Q. I have never -- It's So what I understand this letter is saying is 4 that Outpatient Intravenous Insulin Treatment is the same 5 as APT/MII. 6 MR. AUERBACH: 7 testifying once again. 8 THE COURT: 9 Your Honor, Ms. MacLean is Sustained. And this is little bit difficult because I have asked her to try to tighten it up. 10 So to the extent you can, use open-ended questions 11 but I understand you are also trying to comply with my 12 request. 13 you try to ask open-ended questions. So I am going to sustain that but also just request 14 15 BY MS. MacLEAN: 16 Q. Dr. Elliott, to your knowledge, is Outpatient 17 Intravenous Insulin Treatment the same or substantially 18 similar to APT/MII? 19 A. No, it is not. 20 Q. Why not? 21 A. I think we have gone through that. The pump is 22 different, the medical treatment is different. OIVIT is 23 backwards; it's not physiologic. 24 therapy and MII is physiologic and utilizes a different pump 25 and does not utilize the measurements that are linked to OIVIT It is a whole different 145 1 in the policy. 2 Q. 3 as OIVIT? 4 A. 5 done, no. 6 Q. 7 that to be done? 8 A. Yes. 9 Q. Do you think that that's appropriate? 10 A. No. 11 Q. Does your clinic bill for APT/MII? 12 A. We bill components of it what we do, the therapy 13 14 15 So in your opinion, should APT be billed No, it would be not be appropriate for that to be And do you see here that this letter is directing that we give, so we bill components. Q. Do you bill the components of the treatment process? 16 A. Yes. 17 Q. And is that how you have always billed it? 18 A. Yes. 19 Q. Is that how you billed it when Ron Briggs was 20 being treated there? 21 A. Yes. 22 Q. At that time, did you bill it to 23 Blue Cross/Blue Shield of Montana? 24 A. We did. 25 Q. And did they pay you? 146 1 A. Yes, they did. 2 Q. Dr. Elliott, I would like you to go to Exhibit 8, 3 which has been entered into the record. 4 Exhibit 8-443. And that is Petition 5 A. Yes. 6 Q. Have you had a chance to review this letter? 7 A. Yes. 8 Q. And are you familiar with the articles that are 9 10 referred to in this letter by Blue Cross/Blue Shield of Montana through Mr. Herriges? 11 A. Yes. 12 Q. And do you see below "I", the second or the last 13 sentence in that first paragraph? 14 A. Yes. 15 Q. Does that read or does that paragraph state a 16 conclusion regarding what APT is? 17 A. According to their opinion, yes. 18 Q. What is that conclusion? 19 A. They are basically saying it is, at its basis, a 20 pulsatile insulin therapy and thus no difference, no different 21 than CIIIT or any of the other names by which pulsatile 22 insulin therapy is known. 23 Q. Is that an accurate statement? 24 A. No; it's totally erroneous. 25 Q. And is that for the same reasons we have 147 1 discussed before? 2 A. Yes, ma'am. 3 Q. Do any of the articles referenced here in this 4 letter change that fact? 5 A. No, they do not. 6 Q. If you will go to Page 3 of the Petition 7 Exhibit 8-445. 8 A. Yes. 9 Q. And see under, if you can see under "II", or 10 actually if you could please take a look at the top of that 11 page, it starts off actually on Page 2 and goes to Page 3. 12 Do you see where it refers to OIVIT on Page 2 and then goes 13 to Page 3? 14 A. Yes. 15 Q. And it refers to code G9147 on the top of Page 3? 16 A. Yes. 17 Q. Do you see where it says the directive noted that 18 speaking of the CMS directive, and then there is a quoted 19 paragraph there? 20 A. Yes. 21 Q. Any of these treatments that are noted here, are 22 23 any of them the same as or substantially similar to APT/MII? A. No, none of them are. They all refer to the exact 24 same thing, which is also known as the Harvard protocol. And 25 no, they are, they are not substantially similar at all to 148 1 2 APT/MII. Q. And if you take a look at the, below "II", the 3 first paragraph, do you see the sentence, that second from 4 the last that starts out, "even more telling". 5 A. Yes, I do. 6 Q. And do you see that they are talking about the 7 medical policy 201.028, and it's referenced to the 8 American Diabetes Association standards of medical care of 9 diabetes in 2017? 10 A. Yes. 11 Q. Are you familiar with that article? 12 A. I have not read it, no. 13 Q. Are you familiar with the standards of medical 14 care in diabetes that comes out from the American Diabetes 15 Association? 16 A. I know they do publish that, yes. 17 Q. Is it by any means a peer-reviewed article? 18 A. No, it is not. 19 Q. What is it? 20 A. It is a compilation of data that they are issuing 21 for physicians, patients, health care providers, to be able to 22 just look at and consider. 23 Q. And it's done by whom? 24 A. The members of the American Diabetes Association. 25 I don't know the exact people. 149 1 Q. 2 practice? 3 A. No, absolutely it's not. 4 Q. So could you go down to the next paragraph 5 Is it in any way detailing a standard of It's just information. please. 6 A. Yes. 7 Q. It quotes your article here. 8 Do you see where it's quoting and underlining your article? 9 A. Yes. 10 Q. And do you see where it's saying that because of 11 your article that you refer to "further studies will continue 12 to investigate this treatment," that it's calling it 13 experimental, investigational or unproven? 14 A. That's what they are trying to say, yes. 15 Q. Can you explain why that's not correct? 16 A. It's absolutely not correct. The article stated 17 on its own, there is statistically significant information 18 provided. 19 the end. 20 information that is true and factual as we had it and as we 21 analyzed it and as we published it. 22 anticipate that there will be more information that will be 23 discovered in the future and so it is always something that we 24 put in scientific articles that basically says, you know, 25 there will be more coming and we are hopeful that that will As with any scientific article, it's not, it's not It's a step along the way and we are presenting It's always that we 150 1 further add to the knowledge about the subject so it does not 2 in any way suggest that this is experimental just because we 3 have, we are saying that more information is, would certainly 4 be helpful at some point in time. 5 Q. And does the statement in this letter change at 6 all the fact that APT/MII is not these other treatments and 7 that they are trying to relate them to make it experimental, 8 investigational or unproven? 9 A. No, it is not. 10 Q. Is there any documentation attached to this 11 letter coming from Blue Cross/Blue Shield of Montana that 12 establishes that APT/MII is OIVIT or CIIIT as described by 13 Blue Cross? 14 15 16 17 18 A. No, they never offered any kind of argument at all that would say that it is the same or similar. Q. And if they did offer that argument through and expert, what would you say about that? A. I would question the motivation. As I mentioned 19 before, an independent, completely independent scientist 20 looking at this would never come to the conclusion that these 21 therapies are the same or similar. 22 Q. So did you see that on September 2017, I sent 23 another letter to Blue Cross/Blue Shield of Montana addressed 24 to Mr. Herriges and that is Petition Exhibit 9-471? 25 A. Yes. 151 1 Q. Have you reviewed this letter? 2 A. Yes, I have. 3 Q. And are you familiar with the letters that I 4 attached to that letter? 5 A. Yes, I am. 6 Q. And do these letters accurately describe why APT 7 8 9 10 11 12 is not OIVIT or substantially similar to it? A. Yes. I believe that it can be followed fairly easily and the conclusion would be that it is totally separate and distinct and not the same or similar to OIVIT or CIIIT. Q. And so did you see the next exhibit, Exhibit 10, starting at Petition Exhibit 10-510? 13 A. Yes. 14 Q. That's a letter from Blue Cross/Blue Shield again 15 of Montana and -- 16 A. Yes, it is. 17 Q. And that it was again signed for 18 Blue Cross/Blue Shield of Montana for Mr. Herriges? 19 A. Yes. 20 Q. And you reviewed Mr. Herriges' response in this 21 letter? 22 A. Yes. 23 Q. And do you see in the first paragraph, has 24 Mr. Herriges changed his mind or had Blue Cross/Blue Shield 25 of Montana changed its mind about whether or not APT is CIIIT 152 1 based upon this information? 2 3 4 A. No. They have just reiterated what they said Q. And did you note in my previous letter that I before. 5 asked them to conduct an independent investigation of APT 6 outside of those other treatments? 7 A. Yes, you did. 8 Q. And did they do so prior to responding in this 9 letter? 10 A. No, apparently not. 11 Q. And why do you say, "apparently not"? 12 A. There was nothing in this letter that would say 13 14 15 16 that there was any kind of an independent evaluation. Q. And if there was going to be an independent evaluation, what would you suggest that consist of? A. Well, I would send it out to three scientists who 17 are familiar with diabetes and the treatment, the OIVIT and 18 CIIIT and the Artificial Pancreas Treatment/MII and have them 19 render an opinion and it would be need to be totally separate 20 from Blue Cross or Trina. 21 22 Q. And you did that when submitting your peer- reviewed article, correct? 23 A. We did, yes. 24 Q. Do you note that there are additional references 25 made in this letter from Blue Cross/Blue Shield of Montana 153 1 from October 6th that reference various websites and other 2 information including those from Trina of Arizona? 3 A. Yes. 4 Q. And can you tell me whether or not that changes 5 your analysis of whether APT/MII is substantially similar to 6 or the same as OIVIT or CIIIT? 7 A. No, it is doesn't at all. They are taking it out 8 of context. And the concentration of carbon dioxide that is 9 measured by colorimetry is not used to guide the treatment; it 10 is used to guide the interval between treatments. 11 verbiage would be a little bit ambiguous but clearly the 12 intent is to guide the interval between treatments. 13 words, can the patient hold the carbohydrate charge that is 14 given by the MII treatment for longer than one week? 15 case, we would extend them out to two-week treatments and not 16 have to treat them every week. 17 dioxide measurement just tells you how long between treatments 18 you can go. 19 Q. The In other In which So the use of the carbon And in previous, in other treatments that they 20 are trying to relate to that, that is used for an entirely 21 different purpose, correct? 22 A. Right. The RQ or respiratory quotient was 23 apparently used by people doing OIVIT and CIIIT treatments to 24 guide therapy, which is not what is done with MII. 25 Q. And so is there anything in the information 154 1 provided in this last letter of October 6 that makes APT 2 similar to or substantially similar to or the same as any of 3 these other treatments? 4 A. No, there is nothing in there that would, that 5 would lend any kind of scientific assessment that would say if 6 it was the same or similar to. 7 Q. And have you reviewed the case histories of the 8 plaintiff patients in this matter, including previous medical 9 histories and their affidavits? 10 A. I have done that, yes. 11 Q. And did I ask you to evaluate whether or not you 12 believe there will be irreparable harm if they don't continue 13 to get treatment after yesterday? 14 A. Yes. 15 Q. And if we could, please if you could bring that 16 information that you reviewed regarding Barry Briggs in front 17 of you. 18 A. Yes. 19 Q. Are you familiar with the medical history of 20 Barry Briggs? 21 A. Yes, I am. 22 Q. And what can you tell us about Mr. Briggs' 23 medical history? 24 25 THE COURT: And Ms. MacLean, again we can't go all the way down into the weeds. If he wants to tell me 155 1 about irreparable harm, he can but we have 9 minutes to go 2 before 5. 3 4 BY MS. MacLEAN: 5 Q. 6 7 Okay. So what are the major issues that you see with Mr. Briggs's medical history? A. These two patients illustrate a scientific 8 principal called Koch's postulates, in which you, you initiate 9 a therapy, you see what the result is, you stop the therapy 10 and see if the result changes. 11 back and reinitiate the therapy and see if you get the same 12 result as you did the first time. 13 scientific way to establish efficacy of a treatment. 14 these patients demonstrate Koch's postulates absolutely 15 clearly in which they had deteriorating health prior to 16 starting the MII treatments. 17 recovered most of their health, if not all of it and then when 18 the treatments were stopped by the action of Blue Cross, their 19 health deteriorated again. 20 Briggs has. 22 nonhealing diabetic ulcers. 23 Chiropractic -- 25 It is a very solid Both of Both of them testified that they I am very concerned about the ulcers that Barry 21 24 And if it does, then you go Trina has been demonstrated to be able to heal THE COURT: We published a paper at the Ms. MacLean, we can't just have these narrative responses like this. 156 1 THE WITNESS: 2 THE COURT: 3 Okay. I will stop, your Honor. And I think he has answered on the irreparable injury on the two patients. 4 THE WITNESS: Is that right? Your Honor, there is no doubt there 5 would be irreparable injury to both of these patients if they 6 do not receive the Trina treatment essentially immediately. 7 8 BY MS. MacLEAN: 9 Q. 10 11 And since they started the treatment yesterday, when is the next time they would need the treatment? A. Generally, you start with two treatments in the 12 first week and they are usually, they are usually two or three 13 days from the first one so starting yesterday, they should be 14 treated tomorrow or the next day. 15 16 17 Q. And then the next treatment they would need to receive, what is that? A. Generally, would be once a week. With Mr. Briggs 18 and his ulcers, he needs more aggressive treatment in order to 19 heal those ulcers. 20 those ulcers and saw the pictures. 21 treatment, which may be one to two times a week. 22 Q. Okay. I was unaware that he had, that he had He needs more aggressive And so moving forward, you are saying that 23 they need to be treated immediately and continue that 24 treatment for the course that you laid out in your affidavit? 25 A. Yes. I did lay that out in my affidavit, 157 1 yes ma'am. 2 3 MS. MacLEAN: Your Honor, no more direct at this time for Dr. Elliott. 4 THE COURT: All right. Thank you. I think we 5 only have five minutes left so what I am going to do is talk 6 to everybody about where we go from here. 7 understand it, and I believe the clerk is still in the room 8 there in Dillon, we will not be in Dillon. 9 Dillon on Friday, is that right? 10 No one will be in We will have two people possibly by Real Presence. 11 MS. MacLEAN: 12 THE COURT: 13 So everyone, as I Yes, your Honor. Everyone will be here, other than that, in Great Falls? 14 MS. MacLEAN: Yes, your Honor. And I would expect 15 to have Dr. Elliott be able to watch the testimony of their 16 expert, if possible, just like their expert has done so here. 17 THE COURT: 18 MS. BEATTY: 19 THE COURT: Do you have any objection of that? No objection. That's fine. I am going to tell you 20 we have to be done by 5 or well before on Friday. 21 will be back here starting again at 1 on Friday. 22 And so we So I apologize to people who had to wait. We are 23 getting some substantive testimony in and perhaps I will be 24 able to make a decision so see you on Friday and drive safely 25 everybody. Thank you. 158 1 MR. AUERBACH: 2 MS. MacLEAN: Thank you, your Honor. Thank you, your Honor. 3 4 (Proceedings were adjourned at 4:56 p.m.) 5 6 (The following proceedings were held in open court 7 on February 2, 2018:) 8 9 THE COURT: This is Cause No. DV-17-14044 Trina 10 Health of Montana, LLC, Harold Laron Briggs, Barry Briggs and 11 Harold Grogan versus Health Care Service Corporation d/b/a 12 Blue Cross and Blue Shield of Montana. 13 courtroom are Kimberly Beatty and Daniel Auerbach for 14 Blue Cross/Blue Shield and Erin MacLean is here for the 15 plaintiffs. 16 apologize. And present in the And I can't remember your paralegal's name. 17 MS. MacLEAN: Tanya Robo. 18 THE COURT: 19 MS. MacLEAN: 20 THE COURT: 21 And we need to do a little bit of housekeeping Say again? Tanya Robo, T-A-N-Y-A, R-O-B-O. Thank you. 22 before we start. 23 Cynthia, are you there in the courtroom or is one of the 24 clerks there? 25 So the clerk from Beaverhead County, THE CLERK: Yes, I am here. I 159 1 2 THE COURT: Okay, hi. Thank you for doing this. I appreciate it. 3 I just wanted to make one note for the record. 4 The sound was not stellar so I am sure that that's part of 5 the reason that we don't have all of the exhibits on the 6 minute entry but I wanted to clarify with you what exhibits 7 are in right now and give the lawyers a chance to tell me 8 that I am wrong. 9 So Exhibit 1 is in. That is the injunction bond. 10 That was admitted without objection. 11 little complicated. 12 Excuse me. 13 petition have been admitted. This is where it gets a Exhibit 2 to the petition through -- Exhibit 1 to the petition through 10 to the 14 Do counsel agree with me on that? 15 MS. BEATTY: 16 MS. MacLEAN: 17 THE COURT: Yes, your Honor. Yes. All right. So I'm going to back up a 18 minute, Cynthia, so that you know some of these are hearing 19 exhibits. 20 I don't believe there was a 2 to the hearing. 21 note of a 2 to the hearing, a 2 exhibit to the hearing. 22 have Exhibit 2 to the Petition 1 through 10, but I think 23 that's where we got things a little bit confused. 24 25 Exhibits 1, 3 and 4 to the hearing were admitted. MS. MacLEAN: order. I don't have a We But not to the temporary restraining 160 1 THE COURT: Well, here is what I am going to do. 2 I just want to repeat this one more time and I will give you, 3 Ms. MacLean, a chance to correct this after you get a chance 4 to absorb it and make sure I am right. 5 was a hearing exhibit, is admitted. 6 the petition have been admitted. 7 exhibits which are photos were admitted, and Cynthia, I am 8 going to take possession of the color original photos and 9 give them to my JA, Cheryl, and have her get those down to 10 you. 11 your file. But Exhibit 1, which Exhibits 1 through 10 to Exhibits 3 and 4, hearing I don't see any other workable way to get those in 12 THE CLERK: We appreciate that. 13 THE COURT: Did what I just say make sense to you? 14 THE CLERK: It did. And I can afterwards, I mean 15 not to take up time right now, I can certainly -- or sorry. 16 I just wanted to make sure, I will double check my minute 17 entry and make sure that it is accurate. 18 THE COURT: Okay. And one other thing that we 19 could do is I could have counsel just stipulate. I think we 20 can agree, maybe not to the objections but that an objection 21 was made, just stipulate to what exhibits are in and what 22 aren't and send it to Cynthia in writing so that everyone is 23 on the same sheet of music. 24 dispute but just because of this numbering thing. 25 confusing and there are probably going to be more exhibits I don't think there is any It may be 161 1 admitted or offered today; just fair warning. 2 THE CLERK: Thank you. 3 THE COURT: So I now have exhibits to the hearing 4 3 and 4 which were admitted on Wednesday. 5 All right. So we are going to proceed with the 6 hearing. My court reporter is here. I am hoping the sound 7 will be better today. 8 on the outside of the courthouse in Great Falls so if anyone 9 gets yelled at to slow down or speak up, it's just because I To celebrate, we have people pounding 10 want to make sure the record is clear and Joslyn, my court 11 reporter, can hear it. 12 13 So Dr. Elliott was on the stand. don't think you were done with your examination or were you? 14 15 Ms. MacLean, I MS. MacLEAN: Your Honor, I was done pending redirect. 16 THE COURT: Okay. 17 Mr. Auerbach. 18 (Off the record.) 19 MR. AUERBACH: 20 THE COURT: Thank you. Judge, can you hear me okay? I can hear you and Joslyn, I am going 21 to stop for a minute. 22 going to move the camera so that Dr. Elliott can see you. 23 24 25 All right. She is doing double duty here. We are ready. Thank you. She is 162 1 CROSS-EXAMINATION 2 BY MR. AUERBACH: 3 Q. Good afternoon, Dr. Elliott. Thank you for 4 coming back to offer some more testimony this afternoon. 5 Most of the questions I have for you, sir, are going to be 6 about your testimony that you offered on Wednesday. 7 recall your testimony from a couple days ago? 8 9 A. Do you Well, I don't recall it verbatim and I do have a copy of my deposition in front of me so if you want to point 10 things out to me, I would be happy to look at them and 11 respond. 12 Q. 13 Fair enough. We will go from that. Dr. Elliott, you indicated that you are the 14 medical director and owner of Trina Health of Arizona. 15 that right? 16 17 18 19 20 21 A. I am the Medical Director. Is I am part owner. I am not a complete owner. Q. And do you know own Trina of Arizona with your NP that you testified about? A. No. I own Trina Health of Arizona with my business partner, Berkeley Geddes. 22 Q. And you have had that clinic for four years? 23 A. Four years, yes, sir. 24 Q. Would you agree with me that all Trina clinics 25 across the country are somewhat interrelated? 163 1 A. They, they apply the same therapy. They are not 2 related as far as a business entity but they do apply the same 3 therapy, yes. 4 5 6 7 8 9 10 11 12 13 14 15 Q. So do you receive assistance at your clinic from the mother ship, Trina Health in California? A. I don't know what you mean by assistance. Could you define that for me? Q. Sure. Do you -- Any type of assistance. I guess let's start with do you receive any coding or billing assistance from Trina of California? A. We do our own billing so we have had Trina do some of our billing. Q. We now do our own billing. Do you work with Taylor Romine from Trina in California? A. Per se, we do not at this point in time. Like I 16 say, initially when we opened our clinic, we had our billing 17 done through Trina of California, the mother ship -- as you 18 refer to it -- and we no longer do that. 19 over ourselves. 20 Q. We have taken that But to the best of your knowledge, all Trina 21 clinics in this country offer the exact same service and that 22 would be APT treatment? 23 A. I believe that is true, yes. 24 Q. So an outcome in a lawsuit that precludes a 25 clinic from billing for APT could affect your clinic; is that 164 1 right? 2 3 MS. MacLEAN: Calls for speculation, your Honor. 4 5 Objection. THE COURT: I am going to sustain that and ask you to narrow it. 6 MR. AUERBACH: Sure. 7 8 BY MR. AUERBACH: 9 Q. Dr. Elliott, do you believe that Trina Health of 10 Arizona has had a financial interest in the outcome of this 11 case? 12 A. I am not sure that we do. Blue Cross/Blue Shield 13 of Arizona reimburses us so I don't think I do have a 14 financial, you know, I don't have a financial outcome in this 15 case. 16 17 Q. Does Blue Cross/Blue Shield of Arizona reimburse your clinic for APT services billed as APT? 18 A. It reimburses us for the components that make up 19 the APT service. 20 metabolic therapy because that's what it is. We don't bill it as APT. We bill it as 21 Q. 22 covered service? 23 A. Yes, it is. 24 Q. And you are also aware that if you were to bill 25 And you are aware that metabolic therapy is a this as a G code, that G1947 to be specific, it would not be 165 1 covered. 2 3 Correct? A. Well, that code is not appropriate so we would not bill under that code. 4 Q. That would not be appropriate at all. And I understand that's your opinion. My 5 question is you are aware that that G9147 code would not 6 allow you to receive payment from health insurance companies? 7 Is that right? 8 MS. MacLEAN: Objection, your Honor. 9 THE WITNESS: It makes no difference -- 10 11 THE COURT: hold tight. Hold on, Dr. Elliott. Dr. Elliott, There is an objection. 12 What was the objection? 13 MS. MacLEAN: Dr. Elliott stated previously he 14 doesn't do the billing. 15 asking him these questions is in an area he has not 16 testified to. 17 18 THE COURT: That's not part of what he does so All right. I am going to overrule that. 19 Do you want to repeat the question please? 20 MR. AUERBACH: Sure. 21 22 BY MR. AUERBACH: 23 Q. Dr. Elliott, I was just wondering whether you 24 know that the G9147 code is not a covered service where you 25 would receive reimbursement if you used that for APT. 166 1 A. Do I know that I wouldn't receive reimbursement? 2 Yes, I wouldn't bill it because it's not appropriate to the 3 therapy we provide. 4 Q. Dr. Elliott, you testified on Wednesday at some 5 length about a June 16, 2017 article that you authored. 6 you recall that testimony in general? 7 A. Yes, I do. 8 Q. And for the record, this is the article that 9 10 starts, "Microburst Insulin Infusion", and it's Bates labeled, if you will, Pet's Exhibit 7-436. 11 12 Do THE COURT: So it's part of Exhibit 7 to the petition. 13 MR. AUERBACH: 14 THE COURT: 15 MR. AUERBACH: 16 THE COURT: Correct, your Honor. Will you say the Bates number again? You bet. All right. PET Exhibit 7-436. Thanks. 17 18 BY MR. AUERBACH: 19 Q. Dr. Elliott, you indicated on Wednesday that that 20 study supports your beliefs about the effectiveness of APT; 21 is that fair to say? 22 MS. MacLEAN: 23 misstates the testimony. 24 25 THE COURT: cross-examination. Objection, your Honor. Overruled. That And I am going to allow 167 1 THE WITNESS: Yes, it supports that. 2 3 BY MR. AUERBACH: 4 Q. 5 Dr. Elliott, you are aware of the terminal observational studies, are you not? 6 A. Yes. 7 Q. What are observational studies? 8 A. Observational studies are reports of outcomes of 9 specific, I will say interventions, whether it be an 10 antibiotic or a chemotherapeutic agent or whatever and it's 11 reporting a number of patients that have received those 12 interventions and the outcomes. 13 Q. An observational study is a hindsight study; it's 14 looking back over something that's already occurred. 15 right? 16 A. Depends. Is that If you are collecting the data 17 prospectively, you are reporting it retrospectively but you 18 are collecting the data prospectively. 19 kind of study so it depends on how you, how you intended to 20 report the data. 21 Q. That is a different And this study that you used as the basis for 22 your article or the series of studies were all retrospect; 23 looking back, correct? 24 25 A. Well, it was prospectively-collected data that the various clinic owners knew were going to need to be looked at. 168 1 So it was, it was prospectively collected but when we wrote 2 the paper, we looked back on a couple of years of data, yes. 3 4 Q. they are Trina clinics, right? 5 6 And these clinic owners you are talking about, A. Yes, sir. These are the only ones that are doing the therapy. 7 Q. So it's a group of Trina clinic owners that 8 provided information after it was collected at their own 9 clinics and then you compiled that to make observations about 10 what that data says. Is that fair to say? 11 A. That's absolutely correct, yes. 12 Q. But there is no means of control or randomization 13 for this type of study, is there? 14 A. You know, we have looked at the possibility of 15 randomization but you cannot do a randomized, at least a 16 placebo-controlled trial because the giving the patient 17 glucose and then not giving insulin would end up in patients 18 going into ketoacidosis. 19 we would love to do a prospective randomized placebo 20 controlled trial, it would harm the patients to try to do 21 that. 22 So as much as it would be nice and Now, with respect to whether there is any control 23 group, there certainly is. And that is these patients are all 24 patients that had long-standing diabetic therapy that was 25 being given according to the "standard of care" and they all 169 1 had morbilities that brought them to the Trina Clinic and so 2 comparing patients with -- 3 THE COURT: Dr. Elliott, Dr. Elliott? 4 THE WITNESS: 5 THE COURT: Yes. I am going to ask you to try to listen 6 to the question and answer the question. 7 only have limited time. 8 available but I can't have long narrative answers. 9 THE WITNESS: 10 Again today, we I am trying to make as much time Okay, your Honor. Thank you. The question -- the answer is that there is a 11 control group and that's the patient before going on the 12 Trina therapy. 13 14 BY MR. AUERBACH: 15 Q. But that's not a scientific control group, is it? 16 It's not a control group of a population that is not part of 17 the treatment that's been tested; correct? 18 A. No, it's a scientifically-controlled group in that 19 you are comparing the patient to himself or herself so there 20 are other ways you could compare to other diabetics that 21 didn't receive the treatment. 22 design. 23 24 25 Q. But that's a different study And that different study design is the general model, is it not, for clinical trials? A. No, not, not necessarily. It's a different 170 1 2 study design. Q. The study design you describe is essentially a 3 bunch of Trina people telling anecdotes about their patients; 4 is that right? 5 MS. MacLEAN: 6 THE COURT: 7 MR. AUERBACH: Objection. Argumentative. Sustained. I will withdraw. 8 9 10 BY MR. AUERBACH: Q. Dr. Elliott, there was no control group for this 11 study except for the patients' prior treatment and therefore, 12 the patients are their own control; is that right? 13 A. Yes. 14 Q. There was no independent review of this study for 15 the veracity of the science, was there? 16 MS. MacLEAN: Objection (indiscernible). 17 THE WITNESS: Absolutely. 18 THE COURT: 19 objection. 20 You may answer. 21 How on, hold on, hold on. I have to rule on that. THE WITNESS: Overruled. I have an All right. This was published in a 22 peer-reviewed journal and so there was independent validation 23 of the veracity of the data. 24 25 171 1 BY MR. AUERBACH: 2 Q. 3 Dr. Elliott, this was peer-reviewed from your understanding by editors of this journal, right? 4 A. To be honest, I submitted it to the journal and it 5 came back approved. 6 honest with you. 7 Q. I don't know their, their process, to be Peer review is peer review. So independent investigations that include, for 8 example, an IRB, an institutional review board, would that be 9 more accurate for the scientific results? 10 A. Not necessarily. You need an IRB if you are doing 11 it in an investigation in which the results have not been 12 proven. 13 submit this to, to clinicaltrials.gov, which is the federal 14 registry for trials and they rejected it. 15 not need to have an IRB approval. 16 we did not get it submitted to the clinicaltrials.gov. 17 18 19 In this case, the results were proven. Q. We tried to They said you do This is a proven therapy so Did you receive some kind of written confirmation that APT was a proven therapy as you just testified to? A. We received written confirmation that there was, 20 that they rejected our attempt to register it with the 21 clinicaltrials.gov; yes, we did. 22 Q. You received confirmation that they rejected it 23 but you didn't receive confirmation that APT was a proven 24 treatment, did you? 25 A. That's not their job. They have to just 172 1 decide if -- 2 THE COURT: Dr. Elliott, Dr. Elliott, I just don't 3 have time for witnesses that aren't just going to answer the 4 question. 5 question is so that I can make an intelligent decision here. 6 7 I just need to hear what the answer to the THE WITNESS: They were not ruling on the efficacy of the treatment. 8 9 10 BY MR. AUERBACH: Q. That's what I wanted to clarify because earlier, 11 it sounded contrary. So has there been any independent 12 organization, entity, body that has confirmed that APT is a 13 proven treatment for diabetes? 14 A. I don't know what you mean by, "proven treatment". 15 Q. Is there any entity outside of Trina and its 16 clinics and its providers that has confirmed that APT is a 17 proven therapy? 18 A. Again what's proven therapy? 19 Q. I am going on the language that you have been 20 using, doctor. 21 opposed to unproven. 22 23 24 25 A. I don't understand. You said that APT is a proven therapy as No, it's not investigational. I am not -- It's not investigational. Q. Okay. Are you aware of any entity or individual outside of Trina's clinics and their providers that has 173 1 confirmed that APT is not investigational? 2 A. Well, clinicaltrials.gov told us it wasn't. 3 Q. It was not investigational? 4 A. They did not require a, an IRB approval. 5 6 THE COURT: Will you please answer the question. 7 8 Dr. Elliott, Dr. Elliott? THE WITNESS: I thought I was, your Honor. They -- 9 THE COURT: Well, what I, What the question -- 10 Stop, stop for a moment. 11 looking at it, I am watching the transcript as it's coming 12 out -- the question was it was not investigational. 13 question was whether clinicaltrials.gov told you that it was 14 not investigational. 15 not but I want an answer to that question. THE WITNESS: 17 THE COURT: 18 THE WITNESS: Yes, it is (indiscernible). Pardon me? Yes, they told us it was not investigational. 20 21 The I do understand your position that it's 16 19 The question was -- and I am THE COURT: So you are saying that there is some document saying that? 22 THE WITNESS: Yes. 23 24 BY MR. AUERBACH: 25 Q. We have about six inches of paper in this case 174 1 and it's not a document that I have seen so I apologize. 2 It's -- I asked you that question because I was not aware 3 that any outside entity had indicated APT was not 4 investigational. 5 A. That's not true, no. 6 Q. Outside of clinical trials -- And you are telling me that's not true. 7 THE COURT: 8 THE COURT REPORTER: 9 10 Excuse me. women have theirs muted? I apologize. Could we see if the two I wonder if theirs -- Try that first. 11 THE COURT: Cynthia -- And I have already lost 12 your name, Ms. Romine -- would you make sure that your 13 computers are muted. 14 we are trying to figure out where that's coming from. 15 you. We are just getting some feedback and I think it's gotten quieter. Thank you. Thank Sorry. 16 17 BY MR. AUERBACH: 18 Q. Dr. Elliott, setting this study aside, you 19 indicate in your affidavit, and this is in paragraph 10 for 20 the record of the affidavit of John Elliott? 21 aware of outcomes relating to APT treatment for the last 22 10 years. 23 A. Yes, yes. 24 Q. And in that 10 years, are you aware of any other 25 That you are Do you recall that? study of any kind about the effectiveness of APT? 175 1 2 A. It doesn't refer to studies. 3 4 That paragraph refers to clinical outcomes. THE COURT: Just for the record, that's Document 39 in the docket. 5 MR. AUERBACH: Thank you, Judge. 6 7 BY MR. AUERBACH: 8 Q. 9 the lone study from 2017 that we just spoke about? 10 11 So no other clinical studies for APT other than MS. MacLEAN: Objection. Misstates the answer that the witness just gave. 12 THE COURT: Overruled. 13 14 BY MR. AUERBACH: 15 Q. 16 17 Doctor, were there any other studies other than the June 2017 article that you wrote? A. That specifically deal with APT and how it works 18 and everything, I don't -- There are other studies that deal 19 with the normal function of the pancreas but not specifically 20 with APT. 21 Q. Okay. Dr. Elliott, on Wednesday you testified 22 that you believed Blue Cross/Blue Shield of Montana should 23 have performed an independent investigation of APT before 24 determining that it was either experimental, investigative or 25 unproved. Is that correct? 176 1 A. Yes, yes. 2 Q. I believe you testified that an appropriate 3 independent investigation would include three experts that 4 were independent from Blue Cross or Trina looking at APT to 5 determine whether it was experimental, investigative or 6 unproven. 7 A. I think that that would be a fair evaluation, yes. 8 Q. So if Blue Cross/Blue Shield should, in your 9 Is that correct? mind, have three independent experts evaluated, do you 10 believe the same is true for Trina and having an evaluation 11 done by three independent experts on APT? 12 A. Absolutely. 13 Q. Had that been done? 14 A. Yes, sir, in the peer review, it was done. 15 Q. But you testified, doctor, that you don't know 16 what the peer reviewers did when they reviewed your article? 17 A. They obviously accepted it. 18 Q. And to you, that's sufficient independent expert 19 investigation? 20 A. Yes, it is, absolutely. 21 Q. Okay. And Doctor, I don't want to 22 mischaracterize your testimony, but I believe you testified 23 that an independent reviewer would not conclude that APT is 24 unproven. 25 A. That's what you believed, right? I, I, I -- Show me the page and I can verify it 177 1 or not. 2 Q. I will just ask the question then. Do you 3 believe that an independent reviewer would find APT is 4 proven? 5 A. Based on the article published, yes. 6 Q. Why has Trina not had any other studies done 7 concerning the efficacy and the safety of APT, to the best of 8 your knowledge? 9 A. Well, first of all, there is no, there is no drug 10 company or device company that would sponsor that kind of 11 research. 12 going to be -- Actually it is being sent to an IRB at the 13 University of California-Irvine this month to independently 14 look at the Trina treatment so it is certainly being 15 investigated. 16 Q. There are ongoing independent researchers that are Okay. So a couple of questions on that. 17 said there is no pharmaceutical company or device 18 manufacturer. 19 20 A. 21 Isn't Trina the device manufacturer? Sure. Bionica does. You They make -- Trina doesn't make the devise. It's a separate company. Q. Right. 23 A. They use Bionica pumps, yes. 24 Q. And they tout themselves as the only company that 22 25 But Trina takes credit for Bionica pumps, right? uses Bionica pumps? 178 1 A. That is correct, yes? 2 Q. Okay. But your testimony is there is nobody 3 outside of Trina to pay for the clinical trials to prove that 4 it's safe and effective? 5 A. Correct. 6 Q. Dr. Elliott, are you aware of an Aetna medical 7 policy that specifically excludes, from coverage under its 8 plans, APT treatment? 9 A. You know, I have not read it completely. I am 10 aware that it, that it has done that and based on the same 11 thing that the Blue Cross has done. 12 13 Q. And when you say, "Blue Cross", are you referring to Blue Cross/Blue Shield of Montana? 14 A. Yes. 15 Q. Are you also aware of a Blue Cross/Blue Shield of 16 Alabama medical policy that considers APT synonymous with 17 CIIIT and is therefore experimental, investigative or 18 unproven? 19 A. I am aware of the policy and that they are all the 20 same. 21 same fallacy and logic and not understanding the science. 22 They are all wrong and, you know, they are based on the Q. And the science is, in terms of scientific 23 literature, is based solely on one observational study paper 24 published last year; is that right? 25 A. Well, if you, if any of these entities came and 179 1 sat down and looked at the science, they would understand it. 2 It is also based on the paper from last year, yes. 3 4 5 Q. exhibits in front of you. A. 6 7 Dr. Elliott, I am not sure if you have the Do you have those handy? I believe I do, sir, yes. MR. AUERBACH: Sorry, your Honor. Do you mind if I just take a moment? 8 THE COURT: That's fine. 9 (Off the record.) 10 11 BY MR. AUERBACH: 12 Q. 13 Dr. Elliott, I would ask you to turn to Petitioner Exhibit 10-536. 14 A. I have got that, sir. 15 Q. Okay. 16 17 18 Go ahead. You are familiar with this article, are you not? A. You are going to have to point out what you wanted to ask me. 19 Q. Have you seen this article before? 20 A. I mean I have read through it. 21 Q. And are you aware of the author of this article? 22 MS. MacLEAN: 23 MR. AUERBACH: 24 25 What's the article again. 536. 180 1 BY MR. AUERBACH: 2 Q. You are not aware of the author? 3 A. No. 4 Q. Dr. Elliott, I am going to represent to you that 5 that article is written by G. Ford Gilbert, Ph.D., J.D. 6 MR. AUERBACH: And Your Honor, I would like to, I 7 know the doctor can't get this from where he is at but I 8 would like to offer State's Exhibit -- I'm not sure where we 9 are at. 10 11 THE COURT: Well, hold tight for one minute because Exhibit 10 is in, as I understand it. 12 MR. AUERBACH: Okay. Exhibit 10 is in. 13 14 BY MR. AUERBACH: 15 Q. So Dr. Elliott, I have an article in front of me 16 and it has the exact same text and the same title as I am 17 going to represent to you as Petitioner Exhibit 10-535. 18 you have any reason to believe that this article was not 19 written by Mr. Ford Gilbert? Do 20 A. No, I do not. 21 Q. But you don't know one way or the other whether 22 it was? 23 A. I don't have exact knowledge of that, no. 24 Q. Do you know Ford Gilbert? 25 A. Yes, I do know him. 181 1 Q. He was the founder of Trina Health, is that not 3 A. Well, yes, he was, is. 4 Q. So in this article that you have in front of you, 2 true? 5 I would like you to turn over to Page No. 537. 6 middle of that page, there is a paragraph that starts, "the 7 Trina history". 8 A. 9 And in the Do you see that? Yes. MR. AUERBACH: And, your Honor, if you will bear 10 with me, I would just like the doctor to read one sentence of 11 this into the record. 12 THE COURT: Sure. 13 14 BY MR. AUERBACH: 15 Q. 16 17 Doctor, would you read for the record the first sentence following the "treatment history"? A. "Artificial Pancreas System® and Artificial 18 Pancreas Treatment® are based on many clinical trials and 19 human treatments using several names, including PIVIT 20 Metabolic Treatment, CIIIT," et cetera. 21 Q. Thank you, Doctor. 22 A. Then it goes on to explain it. 23 Q. Okay. 24 25 And the following sentence, in fact, starts, "they are all part of the evolution of APT", right? A. "They are all part of the evolution of APT and all 182 1 were developed using the Bionica infusion devise, a US FDA and 2 CE cleared medical infusion device pump with special abilities 3 and software". 4 saying there. 5 Q. So it's an evolution and that's what it is Okay. So as I understand this, PIVIT, metabolic 6 treatment, CIIIT, C-I-I-I-T, all were developed using the 7 Bionica infusion devise. Is that right? 8 A. Not, not this Bionica infusion devise, no. 9 Q. So a different Bionica infusion device? 10 A. I don't think, I don't those, those other 11 therapies were developed using a Bionica devise at all 12 actually. 13 Q. 14 that they were? 15 A. So do you disagree with Mr. Gilbert's conclusion I believe that it was a different pump that, that 16 Dr. Aoki was using but I don't know. 17 can't tell you. 18 Q. I wasn't there so I And the sentence you just read indicates that APT 19 is based on many clinical trials using several names 20 including PIVIT, and CIIIT. 21 A. As part of the evolution, yes. 22 Q. But I believe your testimony was the 2017 23 24 25 observational studies was the only trial affiliated with APT. A. different. With APT, correct. The other therapies are 183 1 2 3 Q. And those other therapies, do you agree that they are part of the evolution of APT? A. Yes, of course. Those therapies were tried and 4 found to be marginally beneficial. 5 some didn't. 6 effective therapy that sees results in every single patient. 7 8 9 Q. Some patients benefitted, And then there was an evolution to a much more So is it fair to say that APT is an attempt to improve on existing infusion therapies? A. It takes existing information and takes it in a 10 different direction and finds that it is clinically effective 11 in 100 percent of patients. 12 Q. And that clinical effectiveness percentage that 13 you just gave is based on the personal observations of 14 Trina Health Clinics, correct? 15 A. My own personal observations and the personal 16 observations in approximately 10,000 patients of these 17 Trina Health Clinics, yes, sir. 18 Q. But no one outside the walls of Trina Health has 19 an opinion as to the effectiveness of APT that you are 20 aware of? 21 22 MS. MacLEAN: Argumentative. 23 THE COURT: 24 THE WITNESS: 25 Objection, your Honor. Overruled. I mean the only people that are doing it are Trina Clinics so no one else would, you know, be 184 1 in a position to evaluate the patients except for their 2 providers, who are really very astounded at what is happening 3 in the change in their patients. 4 5 BY MR. AUERBACH: 6 Q. Dr. Elliott, if you will go to the next page of 7 that exhibit, which is 10-538. The top paragraph of that 8 page indicates developed in university settings. 9 that? Do you see 10 A. Yes. 11 Q. And it indicates that APT was developed and then 12 tested in a number of university and centers of excellence 13 including Harvard, University of California-Davis and several 14 others. Did I read that first part correctly? 15 A. Yes, you did. 16 Q. To the best of your knowledge, was APT ever 17 18 19 20 21 22 tested at Harvard University? A. The predecessor to APT was tested at Harvard University. Q. APT itself was not. So if APT's predecessor's research was used to create APT, then how are they not substantially similar? A. Because it's an advancement in the device. Take 23 a car, a self-driving car is an advancement potentially on a 24 regular car so it's an advancement. 25 different technology. It's a different, a 185 1 2 Q. But it is still a car. It still gets you from A to B, right? 3 A. You are still using insulin. 4 Q. All right. Dr. Elliott, I would like to ask you 5 a couple of questions about your opinions with respect to the 6 patient plaintiffs in this case, Harold Grogan and 7 Barry Briggs, who we heard testimony from on Wednesday. 8 I will take you back to your affidavit. 9 handy, sir? And Do you have that 10 A. I do. Let me get it for you. Yes, I do. 11 Q. So Dr. Elliott, as part of your role in this 12 case, were you asked to look at Mr. Grogan and Mr. Briggs, 13 Barry Briggs, and consider what future treatment they may 14 need? 15 A. Yes, I was. 16 Q. And what did you review in terms of documents or 17 information to be able to come to a conclusion about what 18 future treatment those individuals would need? 19 A. Yes. I reviewed the affidavits of both 20 Harold Briggs and -- Excuse me, Barry Briggs and Harold Grogan 21 and their supplemental affidavits. 22 for review. 23 24 25 Q. And the, that was my basis Did you review their medical histories in terms of their medical records? A. I did not look at their medical records 186 1 2 directly, no. Q. Dr. Elliott, you have a summary of what you 3 believe would be the appropriate treatment for each of those 4 individuals over the next 12 months. 5 recommended treatment that are in paragraphs 23 with respect 6 to Mr. Grogan and 31 with respect to Barry Briggs. 7 just confirm that that's correct? And those summarize the 8 A. Yes. 9 Q. And it appears from my review that the Can you 10 recommended treatment is identical in terms of frequency for 11 each of these individuals. 12 A. It would be. Is that right? That's the, that's the way that you 13 get the treatment going and observe for the response, then you 14 tailor the therapy through the frequency of need to do the 15 therapy again. 16 patient where they have, have, can store the metabolic charge 17 in the liver and then you can start to space out the 18 treatments from weekly frequently to every two weeks and then 19 after a period of time, even every three weeks. 20 the same for both patients. 21 Q. So it takes about three months to get the Thank you, Dr. Elliott. It would be Would it surprise you to 22 learn that Mr. Grogan received nearly 70 treatments in 2016, 23 for example, using APT? 24 A. Would it surprise me? No, no, it wouldn't. 25 Q. And yet for the next 12 months, you have 187 1 estimated approximately 44 treatments for Mr. Grogan; is 2 that right? 3 A. Again it's an estimate but yes, sir. 4 Q. And if it was, say, Mr. Auerbach who was getting 5 6 treatment, it would still be 44, would it not? A. It would be -- That would be what you would start 7 on, sir, if you needed treatment and it would be based on your 8 response to how many treatments you would need, but yes, you 9 would start that way. 10 Q. Is there some kind of standard of practice in 11 terms of why you start patients with the protocols that you 12 recommended for Mr. Grogan and Mr. Briggs? 13 A. It's a, it's a way to, it's their standard. It's 14 an -- I don't know that I would call it a standard. 15 say that it fits most patients. 16 with his ulcers which I was unaware of would need more 17 intensive treatment in order to heal those ulcers. 18 depending on the morbilities that they have, that would be a 19 good starting point, then you would tailor the frequency of 20 treatment to their response. 21 actually need more treatments than I prescribed. 22 Q. I would I will say that Mr. Grogan So And with Mr. Grogan, he would And I believe you testified on Wednesday that the 23 patients should not receive APT more than two times in a 24 week; is that right? 25 A. No. Actually, that, that, would be a fairly 188 1 vigorous treatment. 2 significant wounds that have actually treated on a daily basis 3 in order to try to heal those wounds. 4 complication that just needs a very intensive treatment and we 5 have been very successful at healing wounds that have not been 6 healing by conventional treatment. 7 8 9 Q. We have had patients with very That's a, you know, a Dr. Elliott, is this just your theory on the correct course to start new APT patients on? A. I don't think it's just my theory. It's what we 10 have experienced in our clinic. 11 recommendation by Trina of here is a schedule that can fit to 12 most of your patients depending on their morbidities. 13 14 15 Q. It's also a general So Trina has some kind of written recommendations for the treatment of, using APT? A. Well, they are just, they are just suggestions. 16 The individual medical directors and the, and practitioners 17 are free to individualize the care. 18 Q. Dr. Elliott, do you consult with an 19 endocrinologist to determine what would be best for a 20 diabetes patient? 21 A. 22 practice. 23 Q. 24 25 Do I? No. Do you consult with any other specialists in the way you administer APT? A. I treat diabetes all the time in my No. 189 1 Q. So Dr. Elliott, there is some testimony in the 2 affidavits that the course of treatment you recommended for 3 Mr. Briggs and Mr. Grogan is the worst case scenario. 4 you now disagree with that knowing more of the conditions of 5 Mr. Grogan? 6 A. Would I would disagree with it and I would, I would say 7 that Mr. Grogan would need more intensive treatment because of 8 these, these two ulcers that he has developed in order to 9 prevent amputation so yes, I would disagree with myself. 10 MS. MacLEAN: Objection, your Honor. I believe 11 that the ulcers that are admitted in those photos, they are 12 Barry Briggs', not Harold Grogan's, to be clear, to clear 13 it up. 14 15 THE COURT: talking about the -- 16 17 THE WITNESS: THE COURT: 19 hang on. 20 this. 21 were referring to? 23 24 25 I did, your Honor, and I apologize -- 18 22 Dr. Elliott, did you hear your lawyer Excuse me. Just let me -- Hang on, Let me finish so that the court reporter can get Do you want to correct that as to which patient you THE WITNESS: Yes. I do apologize, your Honor. am referring to Mr. Briggs who has the ulcers. THE COURT: All right. Thank you. I 190 1 BY MR. AUERBACH: 2 Q. And Dr. Elliott for the record, I was not trying 3 to confusing you between the two. 4 apologize for that. It was my confusion so I 5 A. I didn't think you were, sir. 6 Q. Thank you. 7 Dr. Elliott, I just want to ask a follow-up on that clinicaltrials. -- was it .gov or .org? 8 A. .gov. 9 Q. Has Trina ever made that available to the public 10 that you are aware of? 11 A. 12 tell you. 13 You know, I don't know about that. THE COURT: I can't When you say that -- 14 15 BY MR. AUERBACH: 16 Q. 17 Meaning that letter that you received from clinicaltrials.gov, has that ever been made public by Trina? 18 A. My answer is I don't know. 19 Q. Do you know whether the clinicaltrials.gov letter 20 21 came out prior to your June 2017 article? A. Yes, it did because we were not required to submit 22 an application to them telling them what we were going to do 23 and find out if they would accept it and give recommendations 24 so absolutely, it came before that. 25 Q. If it was such a significant finding, then why 191 1 wasn't it included in your article in June of 2017? 2 A. It didn't need to be. I mean it's a significant 3 finding in that we didn't need to do it. 4 be part of the article, no. 5 Q. Okay. It doesn't need to Dr. Elliott, I am just about done but I 6 have a couple of questions about your organization 7 specifically as it pertains to this case. 8 Arizona has a website, does it not? Trina Health of 9 A. Yes. 10 Q. And I would like you to turn in that exhibit 11 binder you have in front of you to Petitioner Exhibit 10, 12 Page 524 and if you could just let me know when you are 13 there. 14 A. I have got it, sir. 15 Q. Okay. 16 Does that appear to be the first page of a references sheet from Trina Health AZ website? 17 A. Yes. 18 Q. And you are listed there on that, aren't you? 19 A. Yes. 20 Q. And that paragraph under "references" states 21 that, "below are links to articles in cases that provide the 22 proof that APT or" -- Excuse me, "that artificial pancreas 23 treatment works --" 24 MS. MacLEAN: 25 THE COURT: Objection, your Honor. Overruled. Hearsay. It's a statement of a 192 1 party opponent. 2 3 BY MR. AUERBACH: 4 Q. 5 what I just read? 6 7 A. What was the statement you wanted me to comment on? 8 9 Dr. Elliott, does it state that on your website Q. The first sentence under "references" on your website. 10 A. Yes, okay. 11 Q. Can you tell me what that means? 12 A. It means that there are articles out there that 13 medical professionals can look at to make a judgment about the 14 efficacy of the treatment. 15 Q. And what it says though is that below are the 16 links to articles in cases that provide the proof that 17 artificial pancreas treatment works. It says that, right? 18 A. Yes. 19 Q. And if you turn over to the following 20 Page 10-525, it starts with No. 1 and it goes on for several 21 pages. 22 Petitioner's Exhibit 10-533. There are 43 citations in all going back to Do you see that? 23 A. Yes, I do. 24 Q. From my review, it appears that a bunch of these 25 relate to OIVIT, and PIVIT and CIIIT. By way of example, 193 1 would you look at No. 3. It appears to be an article -- 2 A. Yes. 3 Q. It appears to be an article addressing PIVIT. 4 5 6 7 8 9 you agree? A. I don't believe that it does. I think it's just talking about how the pancreas secretes insulin. Q. How about if we go down to No. 4 then. What's the title of that article? A. "Pulsatile intermittent intravenous insulin 10 therapy for attenuation for retinopathy and neuropathy in 11 Type 1 diabetes mellitis." 12 13 14 Q. And Pulsatile Intermittent Intravenous Insulin Therapy is PIVIT, right? A. It is, yes. We put all articles in there that 15 relate to insulin therapy. 16 to look at it to have all the articles. 17 Do Q. We want the physicians that want And I am not going to go through all of these, 18 but just so there is more than one example, if you will turn 19 over to Page 527, No. 11 appears to be an article by Aoki. 20 A. Yes. 21 Q. Can you tell me what the title of that 22 23 24 25 article was? A. Sure. "Chronic Intermittent Intravenous Therapy, a new frontier in diabetes therapy." Q. And Chronic Intermittent Intravenous Therapy is 194 1 C-I-I-I-T, or CIIIT as we all it, correct? 2 A. Sure. 3 Q. So why on your website are there articles, 4 several of them that address the efficacy of PIVIT and CIIIT 5 to support your conclusion that APT works? 6 A. They are not supporting the conclusion that it 7 works. It's really a transparency to provide all articles for 8 a clinician to review. 9 articles and it doesn't in any way say that that's what APT is You know, that doesn't interpret the 10 but it gives the article so that the physicians or other 11 clinical personnel can go and look up the article and make 12 their own judgments. 13 14 15 Q. So would you disagree then that the articles in here are not intended to prove that APT works? A. They are intended to provide information about the 16 Pulsatile Insulin Therapy. 17 the top of that page, is referring to an article that we 18 published so the rest of them are just to provide background 19 information for clinicians. 20 Q. Okay. The main article, if you look at So then that first sentence that links to 21 articles in cases that provide the proof that APT works, 22 that's not right? 23 A. Well, it does not refer to every article in there. 24 And certainly the first article that's on the top that's not 25 numbered is the proof. 195 1 2 Q. Because it appears otherwise, but that's my misunderstanding. 3 So Dr. Elliott then, you stand by the position 4 that APT is different from CIIIT and PIVIT, despite the fact 5 that it has emerged from those technologies. 6 A. Oh, absolutely. Is that right? It's an evolution and that's what 7 happens in medicine and it's totally different from that 8 technology. 9 different way. It started out one way and information led to a They both use insulin and that's the, that's 10 the common link. 11 Q. 12 They are not the same at all. Except for Mr. Gilbert's article from 2015 that says they all use the same pump? 13 MS. MacLEAN: Objection, your Honor. 14 THE WITNESS: You can ask Mr. Gilbert about that. 15 MR. AUERBACH: 16 17 18 19 20 Dr. Elliott, thank you for your time. THE COURT: What was the objection? He has already given the answer but I didn't hear. MS. MacLEAN: It misstated the testimony that was on the record. 21 THE COURT: 22 will speak for itself. All right. Overruled. The record 23 MR. AUERBACH: Thank you, Doctor. 24 THE COURT: 25 Ms. MacLean, you have redirect, I suspect. Thank you. 196 1 2 MS. MacLEAN: Good afternoon, Mr. Elliott, your Honor. 3 THE COURT: Good afternoon. 4 5 REDIRECT EXAMINATION 6 BY MS. MacLEAN: 7 Q. There are a couple of things that I would like to 8 speak further with you about, Dr. Elliott, in relation to the 9 questions that were asked of you. Could you please tell me 10 more about why it would be inappropriate to bill under the 11 code G9147, OIVIT for APT/MII, which is what we are focusing 12 on here? 13 MR. AUERBACH: Your Honor, I am going to object in 14 terms of foundation. 15 that Ms. MacLean asked about when I asked about coding. 16 17 THE COURT: This is the exact line of questioning If she goes down this road, I am going to allow you to pursue it. 18 MR. AUERBACH: 19 THE COURT: 20 THE WITNESS: 21 22 23 24 25 Thank you. Dr. Elliott, did you have a response? What? I was waiting to see if she was going to ask the question or not. THE COURT: let her ask it again. She did ask the question but I will 197 1 BY MS. MacLEAN: 2 Q. Medically speaking, comparing the type of 3 treatments that are G9147, as you stated, you understood when 4 you were asked previously by Mr. Auerbach what that was. 5 APT/MII treatment, what exactly is the difference that makes 6 them substantially different? 7 A. That code is specifically for OIVIT. 8 what MII is. 9 treatment is. 10 11 That is not That's not what the artificial pancreas In my mind, it would be fraudulently billing and I would not do that. Q. And your testimony is that your clinic bills 12 Blue Cross/Blue Shield and does not bill the G9147 code; 13 correct? 14 15 And A. No. We bill under metabolic therapy. We do not use that code nor have we ever used that code. 16 Q. And you would not use that code, correct? 17 A. No, I would not. 18 Q. Even if you were told to do so? 19 A. No, I would not. 20 Q. I'm sorry. I need to look up one of the articles 21 that I was hoping to put in front of you, sir. Could you 22 please take a look at Exhibit 9, Dr. Elliott; specifically 23 Petition Exhibit 9, specifically Page 9-507. 24 A. Yes. 25 Q. Are you familiar with the table that is included 198 1 in this letter? 2 A. I am. 3 Q. Can you tell me what it is please? 4 A. It's a, it's a chart to make clear the differences 5 between MII or Artificial Pancreas Therapy and Outpatient 6 Intravenous Insulin Treatment, OIVIT. 7 Q. And can you succinctly state why these two things 8 are different in a manner that is understandable in relation 9 to this chart so the Court can understand it, sir? 10 A. 11 Sure. OIVIT -- THE COURT: But and just if I could interrupt, 12 please don't read me the chart because I have been reading 13 and I have been keeping up so if you can just point to the 14 differences, that would be helpful. 15 THE WITNESS: Sure. As I stated before, OIVIT or 16 CIIIT, gives an ever-increasing amount of insulin and that 17 gives glucose to keep the patient from becoming hypoglycemic. 18 It is based on a number of measurements and the amount of 19 insulin is dose-based on measurements that are contained in 20 the table. 21 pancreas therapy and the pumps are different. That is totally not true of MII artificial 22 23 BY MS. MacLEAN: 24 Q. 25 And under that code that is directed in the cease and desist letters to be billed by Blue Cross/Blue Shield of 199 1 Montana, these treatments that you say are not being given in 2 APT that are being done in the OIVIT treatment are billed 3 for, correct? 4 A. They are billed for, correct. 5 Q. So they are bundled into that OIVIT treatment, 6 correct? 7 A. That is my understanding, yes. 8 Q. And because you are not using those treatments, 9 10 they should not be bundled into a code that you are billing, correct? 11 12 A. shouldn't be billing for them. 13 14 Q. A. 19 20 21 Well, yeah. I mean, yes, it just shows that it's not what we are doing. 17 18 And is that the reason that you should not be billing for OIVIT for APT/MII? 15 16 If I am not using those treatments, I certainly Q. And it also includes treatment that you are not A. It would include treatments that we are not doing, doing? correct. Q. I am going to talk to you about questioning that 22 indicated that this is not a proven therapy as 23 Blue Cross/Blue Shield of Montana is arguing. 24 succinctly for us how this is a proven therapy, based upon 25 your medical experience and based upon the research that you Please state 200 1 2 have conducted and that you have reviewed. A. Sure. I have been observing these patients 3 undergoing these treatments for four years so a first-hand 4 knowledge of the consistency of results of this therapy. 5 have, I have knowledge that this is not the old therapy of 6 CIIIT or OIVIT, and then based on the results of the studies, 7 the three studies that we conducted, it establishes the 8 mechanism of action of the MII therapy in converting lipid 9 metabolism to carbohydrate metabolism. I It establishes the 10 clinical efficacy of ameliorating the painful diabetic 11 neuropathy in 90-plus percent of patients and it establishes 12 the cost effectiveness of the treatment in preventing 13 emergency department visits and hospitalizations. 14 15 Q. By establishes, is there any question that you these things that you say it establishes is not established? 16 A. 17 are established. 18 Q. 19 These things From your knowledge, what is an investigational, experimental or unproven treatment? 20 21 No, there is no question about it. MR. AUERBACH: your Honor. 22 I am going to object on foundation, He can answer if he can, I guess. THE COURT: Well, hang on a minute. I am going to 23 sustain that and ask you to narrow and lay a little 24 foundation. 25 201 1 BY MS. MacLEAN: 2 Q. Dr. Elliott, through your experience as a medical 3 professional, have you been able to determine what you 4 understand is an experimental, investigational or unproven 5 therapy? 6 A. Yes. 7 Q. How? 8 A. Basically experimental therapy is one in which you 9 don't know the outcome and you are therefore asking a question 10 and trying to find an answer and that would be investigational 11 or experimental. 12 therapy. 13 investigational or experimental in any way. We know the outcome in this, with this It has been established and therefore, it is not 14 Q. And it's also not unproven, correct? 15 A. Absolutely. 16 Q. There were some questions related to safety and It is proven. 17 effectiveness. 18 safety and effectiveness in relation to APT/MII? 19 A. Have there ever been any questions about No, there have not. There have been over 200,000 20 treatments given without a single adverse effect. 21 been no medical legal lawsuits over any of the patients that 22 have been treated as far as safety or effectiveness of the 23 treatment so there is no question about the safety or 24 effectiveness. 25 Q. There have And with regard to further study, have there been 202 1 rationalized reasons that additional clinical studies have 2 not been done on patients other than those studies that were 3 done as described in your article? 4 A. It's a -- Again there is no funding for those 5 studies. 6 undertook to gather data to be able to publish, did so in a 7 peer-reviewed journal and had, had our findings refereed by 8 the peer review people. 9 fashion in the knowledge that we would be wanting to look at 10 11 And the, this is a situation where, where we that data. Q. And so that was done in a calculated And that's what was done. And Dr. Elliott, I am actually specifically 12 speaking to your decision to do that type of study versus 13 doing a clinical trial and how the clinical trial might harm 14 a patient, like you testified to before? 15 A. Yes. A clinical trial, I would love to do a 16 prospective randomized placebo-controlled trial. It would be 17 unethical because it would hurt the patient so we can't get 18 that data. 19 Obviously, in a peer-reviewed journal, they were accepted and 20 felt to be valid. 21 establishing the scientific proof of that data. The trials that we did are very acceptable. It is a different way of looking at data in 22 Q. Is it a lesser way? 23 A. If, if a treatment, if you can design a 24 prospective, which means going forward, randomized, which 25 means the patient gets a treatment or a placebo, double-blind 203 1 where you don't know what the patient is getting, that would 2 be what's considered the gold standard. 3 still very good scientific research. 4 know, instead of an A+, you are getting an A. 5 6 7 8 9 10 Q. Anything else is It just doesn't, you And would you try to get an A+ in a manner that potentially could harm patients? A. Unfortunately, as much as I would like an A+, I could never do something that would harm a patient, so no. Q. And is that what happened in this particular case as far as the research and study that you did? 11 A. Yes. 12 Q. There was a discussion about some 13 Blue Cross/Blue Shield companies who have tried to force 14 providers to bill the G9147 code for APT/MII. 15 of other companies, such as Blue Cross/Blue Shield in Arizona 16 and other insurance companies, that allow the billing that 17 you do at your clinic to be done? 18 MR. AUERBACH: Are you aware Your Honor, I would like to object. 19 It's very argumentative and she is asserting facts that are 20 not in evidence in terms of other Blue Cross/ 21 Blue Shield companies forcing clinics. 22 THE COURT: And I understand that it is 23 argumentative. I don't think it's necessary. 24 your point. 25 nonargumentative way please. I understand If you want to ask the question in a 204 1 MS. MacLEAN: Thank you, your Honor. 2 3 BY MS. MacLEAN: 4 Q. Are you aware of other companies who accept the 5 billing practices that Trina believes is appropriate for 6 APT/MII? 7 A. Yes. 8 Q. And are you billing a number of those insurance 9 companies from your clinic in Arizona? 10 A. Yes. 11 Q. Including Blue Cross of Arizona? 12 A. Yes. 13 Q. Is there anything about the other insurance 14 companies making a decision that if they did so, that APT is 15 a G9147 code, is there anything that makes that accurate? 16 A. No. 17 Q. Have you and other Trina clinics offered to speak 18 with any insurance company representatives to clarify any 19 such misunderstanding? 20 A. Yes. 21 Q. And does the information provided in the exhibits 22 that you have looked at, especially this exhibit attached to 23 Petition Exhibit 9 that we were looking at, specifically show 24 that that's not correct? 25 A. I am sorry. I didn't follow your questioning. 205 1 2 Q. It was a long one. I'm sorry, your Honor, and I'm sorry, Dr. Elliott. 3 If you take a look at Petition Exhibit 9 that we 4 were looking at, that letter that showed why OIVIT and APT 5 are different, has it been established that that is, that 6 these treatments are not substantially the same or the same? 7 A. Yes, it has absolutely been established, yes. 8 Q. And is that to a reasonable degree of medical 9 certainty as far as you are concerned? 10 A. It is to a degree of absolute certainty. 11 Q. With regard to individuals having the expertise 12 to speak about APT/MII, who are those individuals who have 13 the best ability to speak to this treatment and its 14 effectiveness? 15 A. The only people that could speak to it would be 16 someone that has used the treatment and seen the results so it 17 would be the Trina clinics that are medical directors and 18 their nurse practitioners or physicians assistants who are 19 helping to administer the treatments. 20 Q. And are those all licensed health care providers? 21 A. Yes, ma'am. 22 Q. Please take a look at Exhibit 10 that we looked 23 at, specifically the articles in Page 524 to 533. 24 A. Yes. 25 Q. Those articles, was it a medical professional who 206 1 posted those articles on the Trina of Arizona website? 2 A. It was, it was the managing business partner. 3 Q. And did the managing business partner in any way 4 state that these articles made APT/MII substantially similar 5 to OIVIT? 6 7 THE COURT: Well, I mean. Excuse me. I can read these and I am getting concerned about the clock again. 8 MS. MacLEAN: Okay. 9 10 BY MS. MacLEAN: 11 Q. Please take a look at the medical policy 201.208 12 that's attached to the cease and desist letter in 13 Exhibit 4? 14 THE COURT: It's 4 -- 15 MS. MacLEAN: 16 THE COURT: 17 THE WITNESS: There is one at 4-347, your Honor. Thank you. Okay. Got it. 18 19 BY MS. MacLEAN: 20 Q. And Dr. Elliott, does the fact that there has 21 been reference by any Trina clinic to other types of insulin 22 treatments cause APT/MII to be included by reference in this 23 medical policy that you are looking at? 24 A. No, it shouldn't. 25 Q. Is there anything in this medical policy that 207 1 references either the treatment process or the specific 2 treatment of APT/MII? 3 A. No. 4 Q. And with regard to APT/MII, the rationale on 5 Page 3, if you take a look at the first paragraph, the bottom 6 of the first paragraph, where it says "no studies were 7 identified that investigate the proposed mechanism of action 8 of CIIIT in humans", is that accurate whatsoever to APT? 9 A. I'm sorry. 10 Q. Page 4-349 under rationale. 11 A. Okay. 12 Q. First paragraph. 13 A. Okay. 14 Q. At the bottom of the first paragraph, do you see 15 I am not following you. What page? that sentence I just read? 16 A. Yes. 17 Q. Is that entirely inaccurate as to APT/MII? 18 A. Yes. 19 Q. And that's the rationale for this policy used by 20 21 Blue Cross/Blue Shield of Montana to deny this treatment? A. Yes. 22 MS. MacLEAN: Thank you, your Honor. 23 THE COURT: 24 Mr. Auerbach, keeping in mind the clock. 25 MR. AUERBACH: Thank you. Your Honor, I will be brief. 208 1 RECROSS-EXAMINATION 2 BY MR. AUERBACH: 3 Q. 4 Dr. Elliott, I think it has been established you have never treated with OIVIT, PIVIT or CIIIT, correct? 5 A. No, I have never used those treatments, no, sir. 6 Q. And you just told Ms. MacLean that if you have 7 never used APT, you couldn't have an opinion as to its 8 efficacy or its safety, right? 9 A. If I have never used it? 10 Q. Correct. 11 A. I could have an opinion but I would certainly be 12 13 more accurate if I have used it but I could have an opinion. Q. So is it your opinion that APT is so different 14 from OIVIT, PIVIT and CIIIT because you don't really know 15 OIVIT, PIVIT and CIIIT like someone who has used it? 16 A. Well, am I -- Somebody that would have perfect 17 knowledge would have used both and that, there are some people 18 that have that background. 19 the, at the mechanism and delivery of CIIIT and discern that 20 they are totally different. 21 Q. I have used APT and I can look at Dr. Elliott, you were asked about a letter with 22 the Bates No. 9-507, Petition 9-507. 23 Ford Gilbert, correct? 24 25 A. It was a letter from Let me get there. THE COURT: Would you repeat that? 209 1 MR. AUERBACH: 2 THE COURT: 3 THE WITNESS: Sure; 9-507? Thanks. Yes. Okay. 4 5 BY MR. AUERBACH: 6 Q. If you turn over to the last page of that 7 article, it indicates it was written by, that letter was 8 written by Ford Gilbert? 9 A. Yes, I see that. 10 Q. Mr. Gilbert is not a doctor, right? 11 A. No. 12 Q. And his comparison of OIVIT and APT on the chart 13 He is not an M.D. or D.O. that you testified about earlier, that's his opinions, right? 14 15 He is a Ph.D. A. He is the one that invented the therapy so I think he knows more about it than anyone else. 16 Q. So he invented APT but he didn't invent OIVIT, 18 A. Well, he was a coinventor of OIVIT, if you will. 19 Q. Maybe you can explain that because my 17 right? 20 understanding is that you have taken the position that APT is 21 leaps and bounds different than OIVIT but now you are telling 22 me that Mr. Gilbert invented partially OIVIT as well as APT. 23 Can you reconcile that for me? 24 25 A. There is nothing strange about, there is nothing strange about that. Mr. Gilbert and Dr. Aoki were the two 210 1 people that really came up with this initial therapy of OIVIT 2 or PIVIT, et cetera. 3 different direction and became a totally different therapy. 4 So he knows more about both of them than anybody. 5 was not involved in MII so he doesn't even know the total 6 picture so Mr. Gilbert is in a very good position to make that 7 comparison. 8 9 Q. Dr. Aoki Despite the lack of being a doctor; you don't think that discredits his opinions? 10 11 And then it was refined and it went in a A. the facts. 12 Q. I don't think you need to be a doctor to look at You are looking at them. So in the same right, a nondoctor could make a 13 determination that APT and OIVIT are substantially similar, 14 right? 15 A. If they did, they would be wrong but they could. 16 Q. Dr. Elliott, you indicated that there is no 17 18 19 20 21 22 23 24 25 funding for studies of APT, right? A. There is no external funding for studies of APT, correct. Q. Do you believe that Trina has its own source of funding by the charges it receives for using APT? A. I don't believe so. MS. MacLEAN: You'd have to ask -- Objection, your Honor. Calls for speculation. THE COURT: Hold up. Hold up for just a second. 211 1 We have an objection. 2 You are saying calls for speculation? 3 MS. MacLEAN: 4 THE COURT: Yes, your Honor. All right. 5 6 BY MR. AUERBACH: 7 Q. 8 And you said you don't? THE COURT: I am just looking at the testimony. 9 am going to sustain that. 10 MR. AUERBACH: I Okay. 11 12 BY MR. AUERBACH: 13 Q. Dr. Elliott, move on from that. But you did 14 indicate that there is a, there was a request for an IRB for 15 APT for a new investigation; is that right? 16 A. There is a request in at the 17 University of California-Irvine for an expanded investigation 18 into areas that have not been covered before so an IRB would 19 be very appropriate. 20 21 Q. And when you say other areas that have not been covered before, what does that mean? 22 A. The study is looking at a lot of how do I put it? 23 A lot of mechanisms of action of APT as opposed to necessarily 24 efficacy and so it is appropriate to put it in front of 25 an IRB. 212 1 Q. So would it be fair to say there is more 2 investigation to determine how APT actually works with the 3 human body? 4 MS. MacLEAN: Objection, your Honor. 5 THE WITNESS: I would say -- 6 THE COURT: 7 MS. MacLEAN: 8 THE COURT: 9 THE WITNESS: Hold tight. Objection. It mischaracterizes the testimony. Overruled. I would say that it refines what we 10 know, further adding hopefully knowledge about the overall 11 actions of this therapy. 12 works and we just always look forward to other advances that 13 help to give us more information about it. And it, we already know that it 14 15 BY MR. AUERBACH: 16 Q. And is that study, to the best of your knowledge, 17 a prospective study with appropriate safeguards and controls 18 in place? 19 A. That is true, sir, yes. 20 Q. So it would be a very different study than the 21 studies that form the basis for your letter, your article 22 last year? 23 24 25 MS. MacLEAN: Objection, your Honor. Mischaracterizes the testimony. THE COURT: Overruled. 213 1 2 THE WITNESS: design, yes. It would be a different study It would negate what we did. 3 4 BY MR. AUERBACH: 5 Q. If APT is not experimental, not investigational 6 and not unproven, then why would Trina go through what would 7 be a process to get an IRB to oversee an investigation of 8 further uses of APT? 9 A. Well, you are looking for further uses. 10 Q. Okay, or a better understanding of APT. Why 11 would they, why would Trina want to do a study to get a 12 better understanding of something if they already claim it's 13 perfectly proven and not experimental? 14 15 THE COURT: Mr. Auerbach, I am going to let you ask one more time and then I am going to ask you to move on. 16 MR. AUERBACH: Okay. I will move on, your Honor. 17 18 BY MR. AUERBACH: 19 Q. Dr. Elliott, you indicated that you can't do a 20 placebo study to compare that with APT because it could be 21 harmful to the participant. 22 you concluded? Is that a rough summary of what 23 A. Yes. 24 Q. Couldn't you do a control group with someone who 25 receives conventional diabetes treatment? 214 1 A. These patients are, have already gotten that. 2 They are their own control group so that would not add 3 anything. 4 Q. How would it not add -- Would a control group 5 using conventional therapy not offer a baseline to compare 6 against therapies where APT is used? 7 A. It's a different way of doing an investigation. 8 You can use the patient as their own control because they have 9 been on the conventional therapies and they have not worked. 10 So it's just the same, you can do it one way or use other 11 patients. 12 because they are the same as opposed to trying to say this 13 other patient is the same as, you know, one patient that is, 14 say Mr. Briggs, can we -- 15 It's better to use the patient as their own control THE COURT: Dr. Elliott, Dr. Elliott, I just can't 16 have you giving these four-paragraph-long answers or we are 17 going to be here till the cows come home. 18 THE WITNESS: Okay. 19 20 BY MR. AUERBACH: 21 Q. 22 you. Dr. Elliott, I just have one last question for Have you actually read the HCPCS code G9147? 23 A. The exact language in it? 24 Q. Yes. 25 A. I probably did way back when we decided not to, 215 1 that it was not appropriate to bill. 2 read it recently. 3 Q. I don't know that I have Would it surprise you if the actual language of 4 that code did not require that all of the different pieces of 5 OIVIT are included to be considered G9147? 6 7 A. It doesn't matter to me. It's not an appropriate code. 8 9 Would it surprise me? Q. Well, you said it's not appropriate earlier because it includes services that APT doesn't utilize. 10 A. No. If it, if that, if we were doing that therapy, 11 we would be doing those extra services and they would be, they 12 would be billed for. 13 would not apply and so we would not bill it, whether the 14 services were bundled or not. 15 16 They might not get paid but the code MR. AUERBACH: I think we can get back to that later. 17 Thank you, your Honor. 18 THE COURT: I think we have all take our whacks. 19 Is Dr. Elliott finished? 20 MS. MacLEAN: 21 THE COURT: 22 23 24 25 Nothing further. Yes, your Honor. Do you want him to be excused or remain on watching the hearing? MS. MacLEAN: Your Honor, I would like for him to remain as rebuttal please. THE COURT: Thank you. So keeping in mind that we may not 216 1 have time for rebuttal. 2 But Dr. Elliott, what I would like you to do is 3 just turn your machine way down and I will ask Ms. MacLean to 4 call her next witness please. 5 6 MS. MacLEAN: Your Honor, I'd like to call Taylor Romine. 7 THE COURT: 8 So Ms. Romine, if you would please raise your 9 Thank you. right hand and I will actually, I will ask the clerk to swear 10 you in so you folks can turn your machines up for a moment 11 and then we will just leave Ms. Romine's up. Thank you. 12 13 TAYLOR ROMINE, 14 called as a witness, and having been first duly sworn, was 15 examined and testified as follows: 16 17 DIRECT EXAMINATION 18 BY MS. MacLEAN: 19 Q. Please state your full name. 20 A. Taylor Romine. 21 Q. How do you spell your last name? 22 A. R-O-M-I-N-E. 23 Q. Ms. Romine, did you execute the affidavit of 24 Taylor Romine that was filed on January 23rd in this matter 25 as, in support of the temporary restraining order motion? 217 1 A. Yes. 2 Q. And do you have that in front of you? 3 A. I do. 4 THE COURT: For the record, that's Docket 40. 5 6 BY MS. MacLEAN: 7 Q. Docket 40. And would you please take a look at 8 that again and tell me if everything in that affidavit 9 remains accurate. 10 A. 11 I believe so. MS. MacLEAN: Your Honor, I have verified every 12 single affidavit that has been filed with this Court both on 13 October 23 and on January 23. 14 those affidavits as an exhibit. 15 THE COURT: I would like to offer all of All right. What I would like to do, 16 if we are doing that now so I can get a position from the 17 defendants, and I am assuming you are offering them as 18 exhibits in place of testimony? 19 20 MS. MacLEAN: 23 24 25 Well, you asked me not to repeat the testimony, your Honor, so that's what I am doing. 21 22 Yes. THE COURT: that clear. Right. And I am just trying to make All right. So that is Docket Documents No. 5, 6, 7, 8 -- Dr. Elliott? Dr. Elliott? Dr. Elliott? I think we lost him. All right. To continue, 218 1 Documents 36, 37, 38, 39. 2 Would your paralegal be able to text him? 3 MS. MacLEAN: 4 THE COURT: Yes. 39, 40, and I think that's all of the 5 affidavits. 6 record as testimony? 7 defendants for their position on that. 8 9 10 For clarification, your Honor, are affidavits that have been submitted in the case to date? THE COURT: They were all that I was able to find in the document list. MS. BEATTY: All the affidavits, whether they are hers or somebody else's? 15 THE COURT: 16 Dr. Elliott? 17 And let me ask the those all of Ms. Romine's affidavits or are they all 13 14 All right. MS. BEATTY: 11 12 You are asking to have those included in the Correct. I am going to have to figure out a way to cut him off. 18 MS. MacLEAN: 19 THE COURT: I think he muted us and not himself. 20 All right. Thank you. 21 24 25 Thank you. You may proceed. 22 23 She is going to call. I didn't get a response from the defendant. apologize. I I got distracted. MR. AUERBACH: Your Honor, we certainly respect the Court's desire to expedite the process and not go through 219 1 each line of the affidavits; however, to the extent that the 2 testimony that was offered that's different and contradictory 3 to the affidavits, we preserve the right to make a hearsay 4 objection that this is the best evidence of their testimony 5 rather than the hearsay that is their affidavit. 6 THE COURT: Yes, I understand that. Here is what 7 I am going to do is we have had testimony from, I think, and 8 we will have the testimony of Ms. Romine so we will have had 9 the testimony of all of the people who have submitted 10 affidavits and I think that they have been so far vigorously 11 cross-examined. 12 frankly, what these people are testifying to in person is 13 what's of concern to me. 14 trying to do. 15 preliminary injunction hearing that I'm trying to find as 16 much time as possible. 17 up your rights under the Montana Rules of Evidence so I am 18 going to admit them as testimony with the understanding that 19 they are being cross-examined, the witnesses whose affidavits 20 are being admitted are being cross-examined and I am going to 21 take into consideration all of the cross-examination, as well 22 as the contents of the affidavit and I am not treating the 23 affidavit contents as gold. I understand what you are saying and I do appreciate what Ms. MacLean is We have got a little tension here in a 24 All right. 25 MS. MacLEAN: I am also not trying to make you give Thank you, your Honor. 220 1 BY MS. MacLEAN: 2 Q. Mr. Romine, do you work as a biller and coder? 3 A. I do. 4 Q. Where do you work? 5 A. I work at Trina Health, LLC in Sacramento, 6 7 8 California. Q. And has that been referred to here as the Trina corporate office too? Is that the same place? 9 A. Yes, it is. Sorry. Yes, it is. 10 Q. And what do you do for that office? 11 A. I am the lead biller and I audit insurance 12 payments, patient payments, adjustments, claims submissions 13 for Trina Health Clinics around the United States. 14 Q. Do you oversee that process? 15 A. I do. 16 Q. Are you certified as a biller? 17 A. I am. 18 Q. Who certified you? 19 A. The American Medical Billing Association, AMBA. 20 Q. And where did you attend school? 21 A. I went to school at MTI College in Sacramento. 22 Q. What is that school? 23 A. It's a vocational school. 24 Q. Do they certify or do they train billers and 25 coders at that school? 221 1 A. They do. 2 Q. What was your diploma in? 3 A. Medical billing and coding. 4 Q. How is it that you know about Trina Health of 5 6 I received a diploma. Montana, LLC billing? A. It was one of the clinics that was underneath me 7 that I audited their claims submission and their insurance 8 payments. 9 Q. And what does this auditing entail? 10 A. I would audit insurance payments as they came in. 11 I would audit to make sure that the adjustments were entered 12 properly into our electronic software. 13 submissions, patient payments, anything that had to do with 14 payments into the clinic. 15 Q. Thank you. I also audited claims Let's go back to your affidavit that 16 we were talking about earlier and let's take a look at 17 paragraph 2. 18 knowledge to address essentially the billing and coding that 19 has been discussed in this matter in this hearing. 20 watched the entire hearing to understand what that means? This indicates that you have the personal Have you 21 A. I have. 22 Q. And would you have gone back and audited all of 23 the bills submitted and paid by Blue Cross/Blue Shield of 24 Montana in relation to the treatment of Barry Briggs and 25 Harold Grogan? 222 1 A. I have. 2 Q. And in that audit, did you, were you able to 3 accurately state that you have a correct understanding of 4 what has been received to Trina Health of Montana from 5 Blue Cross/Blue Shield of Montana? 6 A. Yes. Yes, I believe so. 7 Q. And are you familiar with Dr. Elliott's 8 recommendations moving forward for the treatment of these two 9 individuals? 10 11 12 A. Yeah, I understand his, his program as far as when they should treat and how many times, yes. Q. And what is your understanding and I guess I can 13 just say is your understanding of those recommendations 14 accurately stated in your affidavit? 15 A. They are, yes. 16 Q. And as a worse case scenario, do you usually see 17 courses of treatment when you are billing them start out 18 similarly and then change a bit along the way? 19 A. Oh, sure. 20 Q. And by worst case -- 21 A. They would start at -- 22 THE COURT: Sure. Ms. Romine, if you would wait until 23 Ms. MacLean finishes, that will make the headache for the 24 court reporter much lighter. 25 THE WITNESS: I'm sorry. 223 1 THE COURT: Thanks. 2 3 BY MS. MacLEAN: 4 Q. By worse case scenario, do you mean or do you 5 believe this to mean that this is the most at this time that 6 we should expect over this timeframe? 7 A. Yes. 8 Q. Do you understand that if the treatment goes 9 better than expected, that it may be less? 10 A. Oh, absolutely. 11 Q. And if the treatment goes worse than expected, 12 13 14 then it potentially would go more but we don't expect that? MR. AUERBACH: Your Honor, I have to lodge an objection -- 15 THE WITNESS: 16 MR. AUERBACH: Sure. -- on foundation and also I have no 17 problem with leading questions at this point, but she is 18 really just testifying rather than asking a leading question. 19 THE COURT: All right. And I will, I know you are 20 trying to walk a line here but I will ask you to ask 21 open-ended questions and I think we are sort of verging into 22 medical testimony rather than billing testimony and I think 23 we got that from Dr. Elliott. 24 25 224 1 BY MS. MacLEAN: 2 Q. 3 4 What is it your job to determine based upon these sorts of recommendations? A. Based on doctors' progress notes and treatment 5 reports, I make sure the CPT codes are correct and I double 6 check the diagnosis codes so that they are at the highest 7 clarity, and that's what I do. 8 9 Q. So it's your job to determine whether or not treatment is billed correctly? 10 A. Yes. 11 Q. And how do you do that? 12 A. By reading treatment reports, progress notes and 13 making sure, checking the manuals, the CPT book manuals that 14 we have chosen the proper codes. 15 Q. And have you done that in relation to this case? 16 A. Yes. 17 Q. Have you done that in relation to OIVIT? 18 A. Um, I -- We don't bill OIVIT. 19 I understand it but we don't bill that. 20 Q. And have you recently read the OIVIT code? 21 A. Oh, yes, yes. 22 Q. Yes, the G9147. 23 says now? 24 A. Yes. 25 Q. Based upon your coding and billing expertise, is Um, the G -So you are up-to-date on what it 225 1 it the correct code for the APT/MII treatment? 2 A. No. 3 Q. Could you please take a look at your affidavit on 4 Page 3, Paragraph No. 8? 5 A. Yes. 6 Q. Is it through your reference to the billing codes 7 and guidelines that you were able to develop what you believe 8 Blue Cross/Blue Shield of Montana will pay for under their 9 policies? 10 A. Yes. 11 Q. Is that to the extent that you are not forced to 12 bill OIVIT under G9147? 13 A. Yes. 14 Q. Could you please take a look at the cease and 15 desist letter in paragraph -- Or sorry, in 16 Petition Exhibit 4. 17 18 THE COURT: Would you just identify for the record the page number? 19 MS. MacLEAN: 20 THE COURT: Yes, ma'am. Thanks. 21 22 BY MS. MacLEAN: 23 Q. 24 Pet Exhibit 344. 25 A. The initial page number is 4-344, Have you seen this document -- I have it in front of me. 226 1 2 Q. So you have to wait until I ask the question and then answer or the court reporter can't take it down. 3 A. Okay. 4 Q. I know we are trying to speed this along but just 5 give me a chance, okay? 6 7 If you could please take a look at the letter and tell me whether or not you have seen this before. 8 A. Yes, I have seen it. 9 Q. When did you first see this letter? 10 A. Sometime in April. 11 It's dated April 12th and we saw it shortly thereafter. 12 Q. And that was in 2017? 13 A. Yes, 2017. 14 Q. Who did you receive it from? 15 A. Trina Health of Montana, LLC. 16 Q. Did you review it for Trina Health 17 of Montana, LLC? 18 A. Yes. 19 Q. What were your conclusions when you reviewed the 20 21 letter? A. That they were requesting us to bill G9147, and if 22 we did not bill that particular code then we were not to 23 submit claims. 24 25 Q. letter? That's your understanding of the content of the 227 1 2 3 4 A. Yes. The science of everything in there, no; but I understand the coding. Q. And is it your job also to look at medical policies in relation to billing? 5 A. Yes. 6 Q. And did you look at the medical policy that was 7 attached to that letter? And that's medical policy 021.028. 8 THE COURT: 9 MS. MacLEAN: Yes, your Honor. 10 THE WITNESS: Would you read the title? 11 And that's at 4-347. I don't know that I have that number. 12 THE COURT: It's called HCSC medical policies. 13 the very top, it says, "Chronic Intermittent Intravenous 14 Insulin Therapy," CV -- excuse me, CIIIT. At 15 16 BY MS. MacLEAN: 17 Q. You said you don't have that number? 18 A. When you were reading the page number but I do 19 20 21 22 23 24 25 have that article. Q. What number are you looking at so we are looking at the same thing? A. That's what I was saying; I don't have a number. I have Page 1 of 9, HCSC medical policies. Q. bottom? There is not a petition exhibit number at the 228 1 A. 2 3 There is not. THE COURT: But I see on the top right of this document, it says, "1 of 9". 4 MS. MacLEAN: 5 THE COURT: 6 That's why. We'll refer to it as 1 of 9. I think she's looking at the same document. 7 8 BY MS. MacLEAN: 9 Q. And did you look at this in April? 10 A. I did. 11 Q. Did you review it? 12 A. I have reviewed it. 13 Q. And did you determine that this covered APT/MII? 14 A. This is a different treatment. 15 Q. So is the answer no? 16 A. No. 17 Q. And after your review, what was your 18 determination about what to do in response to this cease and 19 desist letter? 20 21 22 23 A. We can't bill G9147 so we couldn't submit any Q. And did you have a discussion with Trina Health claims. of Montana regarding that? 24 A. Yes. 25 Q. And what was your recommendation after reviewing 229 1 the patient medical records? 2 3 A. or anybody. 4 5 Q. 8 9 10 11 12 13 14 And where did that put Trina Health of Montana, LLC financially speaking? 6 7 That we can't bill G9147 to Blue Cross/Blue Shield A. In a difficult position because we can't bill Q. And when asked whether or not, based upon your that. evaluation, they should keep their doors open, what was the determination made? A. That if we couldn't bill, there was going to be a hardship keeping the doors open. Q. And so was it decided that the doors must close until this matter is resolved? 15 A. Yes. 16 Q. What percentage of the patients had a 17 Blue Cross/Blue Shield of Montana policy that would have been 18 affected by this at the time? 19 A. At least 40 percent. 20 Q. And of how many patients? 21 A. Ten. 22 Q. And how many of those had primary care coverage 23 for Blue Cross/Blue Shield of Montana? 24 A. Of the 40 percent of them, there was -- I am 25 trying to think. There was three or four that had primary 230 1 care coverage. 2 Q. I'm sorry. Primary courage, I should refer to, 3 meaning their main policy was the Blue Cross/Blue Shield 4 Montana policy? 5 A. Yes. 6 Q. Those three individuals ended up being plaintiffs 7 There were three. in this matter, correct? 8 A. Yes. 9 Q. And the two remaining alive patients are here as 10 plaintiffs? 11 A. Yes. 12 Q. So what did this letter effectively do to 13 Trina Health of Montana, LLC? 14 A. They cannot bill insurance Blue Cross/Blue Shield 15 for payment for services rendered for the patients that they 16 see. 17 Q. What did that result in? 18 A. Closure. 19 20 21 BY MS. MacLEAN: Q. Could you please take a look at Page 2 of 22 Exhibit 4, which essentially, your Honor, I will refer you to 23 4-345 and that is Page 2 of this cease and desist letter. 24 25 THE COURT: Thank you. 231 1 BY MS. MacLEAN: 2 Q. 3 4 Ms. Romine, do you see at the bottom middle of the page where it says, "we request that you notify". A. Yes. 5 6 MS. MacLEAN: Your Honor, do you want to take note of that or can I have her read that small sentence. 7 THE COURT: If it's in, I can read it. 8 9 BY MS. MacLEAN: 10 Q. 11 coverage. 12 A. Yes. 13 Q. Were you surprised to see this requirement in 14 Okay. And it refers to notifying patients of Do you see that? this letter? 15 A. Yes. 16 Q. Why is that? 17 A. They are asking us or they were asking the clinic 18 to personally contact the patients saying that the APT 19 treatment was no longer covered underneath their plans for 20 Blue Cross/Blue Shield. 21 Q. Have you ever seen anything like this before? 22 A. No. 23 Q. Do you do coverage checks for patients when they 24 25 come into the Trina Clinics? A. Sure. We verify insurance coverage before the 232 1 patient even sees the doctor or the medical provider in their 2 clinic. 3 Q. And tell me how you go about doing that. 4 A. We call the insurance company and we have a list 5 of 20 questions, I think it's 20 questions, including codes 6 that we would be billing and we ask if these codes are covered 7 under the plan that the patient has at that time. 8 9 Q. So it's the provider that looks at these, the treatment and determines the code, correct? 10 A. Yes. 11 Q. And that's the appropriate way to determine the 12 coverage? 13 A. Yes. 14 Q. And in this way, Blue Cross/Blue Shield was 15 trying to cause to you do the opposite, correct? 16 A. Yes. They were telling us to bill under the 17 one code. 18 Q. And you said that that's not an appropriate code? 19 A. It is not an appropriate code. 20 Q. And with regard to the fact that 21 Blue Cross/Blue Shield has said that the participating 22 provider agreement applies to that process, do you agree or 23 disagree with that? 24 25 MR. AUERBACH: I'm going to object on foundation. This is getting into a legal issue. 233 1 THE COURT: Sustained. 2 3 BY MS. MacLEAN: 4 Q. 5 Do you agree with participating agreements regularly in your -- 6 THE COURT: Well, let me just stop you. 7 my baliwick so I don't need her to tell me what the 8 interpretation of it is. 9 need her to tell me. 10 I will hear argument but I don't So sustained. MS. MacLEAN: I can't ask her at all about 11 participating provider agreements. 12 THE COURT: 13 MS. MacLEAN: THE COURT: MS. MacLEAN: Well, I am asking her what, how she deals with them and what she does with them. 20 21 Well, you are asking her what the agreement means, right? 18 19 And I am not asking her to agree, your Honor. 16 17 Well, I don't need her interpreting the law. 14 15 THE COURT: If you focus on only her activity, that's fine. 22 23 BY MS. MacLEAN: 24 Q. 25 This is Could you tell me your activity with participating provider agreements on behalf of these 234 1 2 providers? A. Yes. When we call in and verify insurance, we are 3 in network or out of network. 4 and coverage is not determined by those. 5 in-network benefits and out-of-network benefits that they pay 6 to a provider. 7 8 9 Q. That's what participating means Most insurance have And so is the billing determined by these participating provider agreements either? A. No. It's the, what the provider, what the service 10 was rendered is what codes we use to give to the insurance 11 companies, to bill the insurance company. 12 13 Q. And is that the same for both participating providers and nonparticipating providers? 14 A. Yes. 15 Q. So it's not different for one or the other? 16 A. No, no. A participating agreement does not decide 17 what codes we will bill. The provider rendering the service 18 is where we extrapolate our codes that we will bill. 19 Q. And that could be a nonparticipating provider? 20 A. Absolutely. 21 Q. But you still bill the same codes for either? 22 A. Yes. 23 Q. Or both? 24 A. Yes. 25 Q. Is there a particular state where you have 235 1 participating providers and nonparticipating providers that 2 is exemplary of this? 3 4 5 A. I am not sure of your question. But no, participating and nonparticipating, we bill the same way. Q. I am asking if there is a state in the 6 United States where you have both, that bill the same way in 7 that same state dealing with the same insurance company. 8 A. Oh, yes; Texas. 9 Q. And do you oversee the billing in Texas also? 10 A. I do. 11 12 MR. AUERBACH: relevance. 13 Your Honor, I am going to object on This is kind of going nowhere here. THE COURT: I am going to sustain that and I am 14 going to ask, we are going to take a breather. 15 made Joslyn go longer than I should have so we will come back 16 in 10 minutes. 17 18 I will ask you to -- MS. MacLEAN: I just have three more questions, your Honor. 19 20 I know I have THE COURT: come back. All right. We will do those when we Thanks. 21 (Brief break.) 22 THE COURT: Keeping in mind the clock because I 23 want to get this done today, I would really like to have the 24 opportunity to ask the lawyers a couple questions. 25 MS. MacLEAN: Thank you, your Honor. And I wasn't 236 1 trying to go onto a tangent with Texas. 2 relation to this case and HCSC, the defendant, to Texas. 3 THE COURT: There is a specific I will give you a narrow opportunity 4 keeping in mind that what we were doing here, a preliminary 5 injunction hearing. 6 7 MS. MacLEAN: I understand, your Honor. don't want to fall short on the merits. 8 THE COURT: All right. I just Thank you. Thank you. 9 10 BY MS. MacLEAN: 11 Q. Ms. Romine, do you deal with 12 Blue Cross/Blue Shield of Texas in your billing processes for 13 these clinics in Texas? 14 A. Yes. 15 Q. And do those clinics bill in the same way that 16 Trina Health of Montana billed prior to the cease and desist 17 letter in April of 2017? 18 A. Yes. 19 Q. And they currently bill that way? 20 A. Yes. 21 Q. And those payments or those bills are being paid 22 23 24 25 by Blue Cross/Blue Shield of Texas, correct? A. Yes. THE COURT: Before you go further, Ms. Romine, are you in -- This is a question from the clerk. Are you in 237 1 Sacramento or Salt Lake or none of the above? 2 THE WITNESS: 3 THE COURT: I am in Salt Lake City. Thank you. 4 5 BY MS. MacLEAN: 6 Q. Ms. Romine, please take a look at 7 Petition Exhibit 8. 8 a letter from August 28, 2017 from 9 Blue Cross/Blue Shield of Montana. 10 A. Do you have that in front of you? I don't think I have that in front of me. 11 THE COURT: 12 MS. MacLEAN: 13 And that is admitted. Okay. I have only have one area of questioning related to that for you. 14 And, your Honor, I think I can make it short if I 15 read to her what I am looking at. 16 THE COURT: 17 It's As long as it's not a long recitation. 18 MS. MacLEAN: I understand, your Honor. 19 20 BY MS. MacLEAN: 21 Q. This letter is stating on Page 4 under "III" by 22 Mr. Herriges on behalf of Blue Cross/Blue Shield of Montana, 23 it says, "In closing, I did want to take the opportunity to 24 clarify one matter from our April 2017 cease and desist 25 letters. In our letters, we provided a table of procedure 238 1 codes that your client has been billing in place of G9147. 2 Our letters were not meant and should not be interpreted to 3 mean procedure codes featured therein cannot be --" 4 THE COURT: Slow down. 5 MS. MacLEAN: Thanks. 6 7 BY MS. MacLEAN: 8 Q. " -- in addition to G9147. In fact, medical 9 policy medical 201.208 indicates that a variety of procedure 10 codes may be utilized in addition to G9147, which applies to 11 the outpatient insulin component of CIIIT for subsidiary 12 services or supplies provided in connection with CIIIT/APT 13 including but not limited to 94681, 96365 and 96366". 14 then it goes on to say, "To the extent our April letters are 15 interpreted as a prohibition in that regard, consider them 16 modified as per this paragraph". 17 this? And Do you remember reading 18 A. Yes. 19 Q. Does it change anything about your analysis on 20 the cease and desist letters? 21 A. No because I wouldn't put G9147 on a claim. 22 Q. Why not? 23 A. Well, it, it -- 24 THE COURT: Well, I think she answered that. 25 MR. AUERBACH: She has. 239 1 THE COURT: I think I understand why she wouldn't. 2 3 BY MS. MacLEAN: 4 Q. 5 codes, correct. 6 A. No. 7 Q. Why wouldn't you do that in addition to these 8 9 And you wouldn't do that in addition to other other codes? A. Well, we don't do that treatment so I wouldn't put 10 it on a claim. 11 hard time understanding why Blue Cross/Blue Shield would say 12 that because obviously, they think those codes are included. 13 But in addition to other codes, I am having a THE COURT: Well, hang on. I don't need, I 14 don't need to have the witness telling me what 15 Blue Cross/Blue Shield thinks. 16 day if we are telling me what everyone else thinks. We are going to be here all 17 18 BY MS. MacLEAN: 19 Q. 20 I would like to you speak specifically to double billing. 21 A. That's where I was headed. 22 Q. Okay. 23 A. So if G9147 includes 96365 and then I bill 96365, 24 I have billed it a one-hour treatment twice so it looks like I 25 billed the first hour of therapy twice. You can't bill a 240 1 first hour twice. 2 Q. 3 You can't bill the same procedure twice accurately, correct? 4 A. That is correct. 5 Q. And what happens if you do that? 6 A. Well, it would appear I would be committing fraud 7 8 9 or an entire treatment would be denied. Q. So did this letter change anything about the way that you could bill based upon the cease and desist letters? 10 A. 11 can't bill G9147. 12 Q. 13 14 Well, it changed that we couldn't bill because we Let's take a look at Petition Exhibit 10. Do you have that in front of you? A. I don't. 15 THE COURT: 16 replowing the same ground, right? 17 I just want to make sure we aren't MS. MacLEAN: We are not, your Honor. 18 19 BY MS. MacLEAN: 20 Q. In this letter, Petition Exhibit 10 on Page 4. 21 If you look under "III" on Page 4, again it's a letter from 22 Blue Cross/Blue Shield of Montana dated October 6, 2017, 23 written about, "I, Christopher Herriges, on behalf of Blue 24 Cross," it goes into saying that his letter that we just 25 discussed was not intended to be a billing trap. In your 241 1 opinion, is that inaccurate? 2 A. Yes. It makes me nervous. 3 Q. Why is that? 4 A. Because it is asking me to bill for a treatment 5 that does not fit us and then as the codes that do fit us 6 and are correct for us, approved codes that describe what 7 was rendered in Trina Health Montana, LLC plus a code that 8 does not describe the service rendered at Trina Health 9 Montana, LLC. 10 Q. And so the way that you would like to bill it is 11 just for the codes that do apply, correct, and that's the way 12 you have been billing it? 13 14 15 16 17 18 A. Yes. We are using approved codes that explain what was rendered on a particular day a patient came in. Q. And are those codes covered by the Blue Cross/ Blue Shield of Montana policy, as far as you can tell? A. Yes, when we called, they were covered. MS. MacLEAN: 19 this time, your Honor. 20 THE COURT: 21 Mr. Auerbach. 22 MR. AUERBACH: 23 24 25 Thank you. Thank you. No further questions at All right. I will be brief, your Honor. 242 1 CROSS-EXAMINATION 2 BY MR. AUERBACH: 3 Q. 4 Good afternoon, Ms. Romine. You heard Julie Briggs' testimony on Wednesday, did you not? 5 A. I did. 6 Q. And she deferred to you on a couple of points so 7 I am going to ask you about those since they were raised by 8 Ms. MacLean. 9 Montana, 40 percent of their patients were Blue Cross 10 You said that 40 percent of Trina Health in insureds; is that right? 11 A. 12 April 12th, 2017. 13 Q. 14 Yes. Okay. At the time we received the letter of So that would leave 60 percent that were not insured by Blue Cross/Blue Shield of Montana, right? 15 A. Correct. 16 Q. Did you advise Trina of Montana that they could 17 not bill those non-Blue Cross beneficiaries? 18 A. I did not. 19 Q. Is there a reason why, in your opinion, that 20 Trina Health of Montana could not have billed for APT 21 services provided to non-Blue Cross beneficiaries? 22 23 24 25 A. I can't give you any specifics, no. I spoke to the Blue Cross/Blue Shield patients. Q. In your testimony earlier, I just want to make sure this is clear, you said that Trina Health of Montana 243 1 could not bill the G9147 to anybody. Is that correct? 2 A. I agree. Yes, not any insurance company, yes. 3 Q. But there was nothing stopping Trina in Montana 4 for billing other insurance companies for APT treatment, 5 was there? 6 A. No. 7 Q. Then why would Trina Health of Montana have to 8 shut down, in your opinion, if it could not bill Blue Cross 9 insureds but it could bill for APT services provided to other 10 patients? 11 A. Well, I don't know the financials in Dillon, 12 Montana. 13 bills if you are rendering services and that aren't going to 14 be paid. 15 chairs and supplies comes from being able to be reimbursed by 16 the insurance companies for services rendered. 17 Q. But I do know it's a hardship if you can't pay your Part of the payment for keeping the building and the I understand. And as you are sitting here today, 18 you don't know whether Trina Health of Montana could have 19 stayed open relying on patients from non -- Excuse me, 20 payments from non-BCBS-insured patients? 21 A. I cannot state for a fact, no. 22 Q. So did you advise Trina Health of Montana to 23 24 25 close their doors in April of 2017? A. No. I advised them not to bill G9147 to Blue Cross/Blue Shield. 244 1 Q. So to the best of your knowledge, the decision to 2 close the doors was up to Julie Briggs and someone else at 3 Trina Health in Montana? 4 A. I am not sure who made that decision. 5 Q. But you didn't tell them to do that, to close? 6 A. Me personally, no, I did not tell them to do that. 7 Q. Are you aware of anybody else at Trina corporate 8 that advised Trina Health of Montana to close their doors in 9 April of 2017? 10 A. No. 11 Q. Did you ever advise the Trina Health of Montana 12 people billers that they could not provide APT treatment to 13 any patients? 14 A. No. 15 THE COURT: I didn't hear your answer, ma'am. 16 THE WITNESS: Oh, sorry. No. 17 18 BY MR. AUERBACH: 19 Q. 20 Do you know who insured the non-Blue Cross insureds amongst the -- 21 A. Most of the -- 22 Q -- Trina Health patients? 23 24 25 THE COURT: Wait, wait, wait, wait. have to wait until he finishes please. Ma'am, you 245 1 BY MR. AUERBACH: 2 Q. Poor question. Do you know what insurance 3 companies provided coverage for Trina Health Montana's 4 patients other than Blue Cross? 5 A. There was, um, a mixture. I couldn't tell you the 6 exact mixture of the other six but there is a mixture of 7 insurance companies. 8 Montana, there is not a lot of options to coverage for 9 patients. 10 Q. I know that there is, looking in Dillon, Are you aware of whether any of those other six 11 patients' insurers indicated that they would not pay for the 12 APT treatment as of April 2017? 13 A. No. 14 Q. I just want to make sure I understood this 15 testimony. 16 are not supposed to tell their patients whether they have 17 coverage or not for a given service? 18 A. Is it your testimony that clinics and providers No. When we called Blue Cross/Blue Shield, we 19 have an entire form where we ask the questions that specify 20 the codes that we are going to bill when we call. 21 insurance company tells us that it is covered and that the 22 patient is eligible, we go ahead and then we have them see the 23 providers and we set up the treatment. 24 told that Blue Cross/Blue Shield would not cover those 25 services after we had already called and asked for that And when an And then we were not 246 1 coverage and -- till that letter showed up. That's why I say 2 -- So for specific, one of the plaintiffs, we called, we asked 3 Blue Cross/Blue Shield, "are these codes covered"? 4 Blue Cross/Blue Shield said yes. 5 and Blue Cross/Blue Shield said, "We have to bill this 6 particular code G9147, and that we have to then tell our 7 patients that Blue Cross/Blue Shield doesn't cover the 8 treatment". Then we received a letter So that's where I was confused. 9 Q. 10 question. 11 Blue Cross insured that the Blue Cross letter indicated that 12 the clinic should advise its patients that APT was not a 13 covered service, that that was incorrect or improper? 14 A. And I guess I didn't get an answer to my Is it your testimony that in your example, if the Yes because that code, after we informed our 15 patients that G9147, a code that doesn't fit us, is not 16 covered. 17 Q. So -- 18 A. And we are not going to bill that code. 19 Q. I apologize. I didn't mean to interrupt. I 20 understand you disagree with the coding. 21 would it still be proper for the clinic to be the subterfuge 22 to convey the information that Blue Cross is telling the 23 clinic onto the patients? 24 25 A. meaning. My question is I guess I am not understanding what you are 247 1 Q. Okay. I will make it really simple. If an 2 insurance company tells you as a biller, "We don't cover 3 that," whatever it is, okay, you understand that? 4 A. Yes. 5 Q. Do you feel it would be appropriate for you then 6 to tell the patient, "the insurance company says they won't 7 cover that"? 8 9 A. Yes, this treatment is not covered; is that what you are asking me? 10 Q. Yes. That's what I am asking. 11 A. Yes, yes. 12 Q. Ms. Romine, have you been involved in responding 13 to any federal investigations relating to Trina Health of 14 Montana? 15 A. I have responded with affidavits for 16 Blue Cross/Blue Shield and I have responded to an audit done 17 by Medicare. 18 19 Q. 22 Yes. Do you know when that CMS or Medicare audit was? 20 21 I am not -- Is that what you are asking me? A. 2017. Um, I want to say it was in the early part of I don't know that I can give you an exact date. Q. And do you know whether, as a result of that 23 audit, Trina Health of Montana was no longer able to bill 24 Medicare for services? 25 A. I know that they are still, there was a response 248 1 to a rebuttal and they have 180 days so we are still, we don't 2 have results. 3 of that audit, if that's what you are asking me. 4 Q. CMS has not given us results to their findings I am just asking whether Trina Health of Montana 5 has been able to bill for APT since that audit started in 6 early 2017. 7 A. No. 8 MR. AUERBACH: 9 THE COURT: 10 Thank you, Ms. Romine. Thank you. Ms. MacLean. 11 12 REDIRECT EXAMINATION 13 BY MS. MacLEAN: 14 Q. Ms. Romine, I just wanted to bring you back to 15 the fact that you were participating in a discussion in April 16 of 2017 where it was decided, based upon the cease and desist 17 letter received from Blue Cross/Blue Shield, that Trina of 18 Montana, LLC had to shut its doors, correct? 19 A. Yeah, I participated but I didn't make the 20 decision. Is that -- I -- 21 Q. We understand. We understand that eventually the 22 owner has to make the decision. But you did participate in 23 that and that advice was used that you were giving that no 24 billing could be done in order to make that decision, 25 correct? 249 1 A. Yes. Yes, we can't bill; that's correct. 2 Q. And the discussion in that was that once this 3 letter was received, the cost of treatment and treatment 4 providers and supplies simply couldn't be covered, correct? 5 Do you remember that? 6 MR. AUERBACH: 7 THE WITNESS: 8 MR. AUERBACH: 9 THE COURT: I'm going to object, your Honor. Correct. This is hearsay. Sustained. 10 11 BY MS. MacLEAN: 12 Q. 13 supplies? 14 A. What was discussed regarding treatment and That the payments help pay for those treatments 15 supplies, rent, coverage of the chairs, lights, what it takes 16 to keep a clinic open and operational. 17 Q. And prior to receiving this cease and desist 18 letter, there were no discussions of Trina Health of Montana 19 having to shut down, correct? 20 A. No. 21 Q. And as you noted, there are no other findings 22 from any other insurance companies that sent a cease and 23 desist letter telling Trina of Montana that they had to bill 24 G9147, correct? 25 A. No findings. 250 1 MS. MacLEAN: 2 THE COURT: 3 MR. AUERBACH: 4 THE COURT: 5 May this witness be excused? 6 MS. MacLEAN: 7 (Witness excused.) 8 THE COURT: 9 MS. MacLEAN: 10 THE COURT: Thank you. Mr. Auerbach? Nothing further, your Honor. All right. Thank you. Yes, your Honor. Thank you. Do you want her to remain on the line? Yes, please, your Honor. So Ms. Romine, if you would just 11 please turn your sound off again and I think everyone has 12 theirs turned off on the video. 13 14 15 16 Do we have any other witnesses from the plaintiffs? MS. MacLEAN: further witnesses at this time. 17 THE COURT: 18 Defendants. 19 MS. BEATTY: 20 21 22 23 24 25 Your Honor, the plaintiffs have no Thank you. Thank you. Yes. We would like to call Dr. Pujol please. THE COURT: will swear you in. Doctor, if you would come forward, I Right there is fine. 251 1 JEAN-PIERRE PUJOL, 2 called as a witness and having been first duly sworn, was 3 examination and testified as follows: 4 5 6 THE COURT: You may have a seat and please speak into the microphone. 7 MS. MacLEAN: Your Honor, before Dr. Pujol 8 testifies, I'd like to object to them having an expert 9 witness on this treatment. I don't believe that we have 10 received any information and it's my understanding that the 11 other side, Blue Cross/Blue Shield of Montana, intends to 12 offer him as an expert witness. 13 anything that shows that he is an expert on the matters for 14 them in this case. 15 THE COURT: We don't have a CV or have I will take your, I will take note of 16 your objection but I am going to overrule it. 17 point, what I am going to do is expect a foundation to be 18 laid under Rule 702. 19 MS. BEATTY: And at this Your Honor, as one other preliminary 20 comment, I am cognizant of the clock, I am cognizant of your 21 prior statement that you don't want us to go through 22 contracts and policies that are in the record that you can 23 read. 24 along those lines. 25 briefing on those issues and not have to go through them So I had some testimony for each of our two witnesses If you would permit me instead to do 252 1 here, I think I can speed up the process. 2 THE COURT: I will allow both sides to do that. 3 It's going to be prompt briefing so that I can issue a prompt 4 order. 5 little time at the end of hearing but I would appreciate 6 that. But we can talk about that as soon as we have a Thank you. 7 MS. BEATTY: Thank you. 8 9 10 DIRECT EXAMINATION BY MS. BEATTY: 11 12 Q. address and title. 13 14 Dr. Pujol, could you please state your name, A. Sure. Jean-Pierre Pujol, medical director, Blue Cross/Blue Shield, Helena Montana. 15 THE COURT: Would you pull that microphone towards 16 you a little bit and speak up and please spell your last 17 name. 18 19 20 21 THE WITNESS: P-U-J-O-L. Jean, J-E-A-N, Pierre, P-I-E-R-R-E. THE COURT: Thank you. And you are fairly soft-spoken and you've probably been told that before. 22 THE WITNESS: 23 THE COURT: Um, sometimes. So Joslyn keeps a stack of bricks 24 right beside her and so she is going to wing them at me or 25 you if you don't speak up. 253 1 2 THE WITNESS: As a physician in a courtroom, it's always a little bit nerve-wracking. 3 4 I'll try to. THE COURT: Understood. I will try not to be too hard on you. 5 THE WITNESS: Thank you. 6 7 8 9 10 BY MS. BEATTY: Q. Dr. Pujol, would you just very briefly provide the Court with a synopsis of your educational background. A. Went to Xavier University in Cincinnati Ohio, 11 University of Kentucky in Lexington, Kentucky; then my 12 residency in pediatrics in LaCrosse, Wisconsin, 13 Gundersen Clinic. 14 Q. 15 16 Can you also give a very brief practice background, what have you done in your career? A. Somewhat varied by primarily general practice, 17 pediatrics and primarily urgent care. 18 largest amount of my time spent doing urgent care. 19 20 Q. That was probably my How many years have you been practicing approximately? 21 A. Since 1982. 22 Q. What's your current position? 23 A. Medical director, Blue Cross/Blue Shield. 24 Q. Blue Cross/Blue Shield of Montana? 25 A. Montana, yes, ma'am. 254 1 2 3 Q. And what are your, briefly what are your responsibilities as medical director? A. Primarily predeterminations, preauthorizations. 4 In other words, people asking permission for hospitalizations, 5 certain treatment programs. 6 appeal process where people who have been denied coverage ask 7 for a second look. 8 I sit on a few committees that are not really relevant, I 9 don't feel, to here. Then I am also involved in the I also look on the claims end as well, and 10 Q. Okay. 11 A. Three years, a little over three years. 12 Q. Are you familiar with this case with the 13 And how long have you held this position? complaint that was, the petition that was filed? 14 A. Yes, ma'am. 15 Q. Have you been in the courtroom for the two days 16 of testimony we have had? 17 A. Yes. 18 Q. So Dr. Pujol, I know this is difficult. 19 Let me finish my question and then I will let you answer -- 20 A. Oh, sorry -- 21 Q -- and that will help the court reporter get an 22 accurate record. Okay. So you were in the courtroom for the 23 last two days of the plaintiff's witnesses' testimony? 24 A. Yes, ma'am. 25 Q. Does Blue Cross/Blue Shield have a medical policy 255 1 committee? 2 A. Yes. 3 Q. Are you familiar with that committee? 4 A. Yes. 5 Q. Are you familiar with what that committee does? 6 A. Yes. 7 Q. And you are familiar with how that committee 8 operates? 9 A. Yes. 10 Q. Can you please tell me what the function of that 11 12 committee is? A. To, to provide review of -- Well, to, to ensure 13 that all the health plans in HCSC try to utilize the same 14 policies. 15 recommendation and comes out with a policy. The committee reviews information and then makes a 16 Q. Okay. 17 A. They meet at least once a week and often, more 18 How often does that committee meet? often than that and quarterly in person. 19 Q. Okay. And who sits on that committee? 20 A. A medical director, one medical director from each 21 of the five plans that are part of HCSC and then one other 22 medical director from what's called the enterprise or HCSC; so 23 six doctors. 24 25 Q. Is that medical policy committee, is it responsible for preparing medical policies that 256 1 Blue Cross/Blue Shield Montana uses to administer its plans? 2 A. Yes. 3 Q. And so is it fair to say that the policies that 4 this committee prepares are used to determine, in part, 5 covered services and noncovered services for its plans? 6 A. Yes. 7 Q. What does the policy committee review or consider 8 9 when it's trying to adopt or amend a medical policy? A. They use a variety of sources. Some are 10 scientific articles that they review. 11 independent organizations such as Hayes Technology, 12 Cochrane Reviews. 13 THE COURT: 14 THE WITNESS: 15 What was the last word you used? Cochrane reviews. That's actually -- 16 17 They also review THE COURT: I'm just trying to make sure it's clear for the court reporter. 18 THE WITNESS: Oh, sorry. They also utilize the 19 Blue Cross/Blue Shield Association Technology Evaluation 20 Center. 21 physicians as well as doctoral level scientists who come from 22 an academic or research-based affiliations and they do timely 23 rigorous, scientific rigorous evaluations of procedures 24 techniques. 25 standards, what's going on in the community. They are commonly known as TEC. This is a group of In addition to that, we look at community We also look at 257 1 other health plans, what their policies might be. 2 utilize appeals. 3 overturned. 4 rationale and sometimes have to make judgments. 5 utilize heavily specialized societies, hitting what's 6 pertinent to this case, the American Association of Clinical 7 Endocrinologists, but general guidelines put out from these 8 societies. 9 Q. We also When we have an appeal, sometimes we are And when we are overturned, we look at their We also Do you also, does this committee also consult 10 with expert physicians in the particular field of policies 11 being reviewed? 12 A. 13 will. 14 Sorry. Yes, we do when necessary. We will, we I am saying "we", but the committee does. Q. Thank you. And how does the committee then take 15 all of this various information and distill it into something 16 that's useable for the committee? 17 A. The actual process, I am not certain. They take 18 that information, they have discussions on it and then come to 19 a consensus and put it into policy. 20 language but essentially the doctors are making the decision. 21 22 Q. They have helped with the And once those policies are then drafted, then put into place, are they ever reviewed or updated? 23 A. 24 reviewed. 25 out. They are every year, they, every one of them gets They also are reviewed as new information comes For example, as I mentioned, if we have overturns on 258 1 appeals, then we might look at that or if one of the other 2 medical directors, for example, myself, reads something new, 3 see some articles, we will present it to the policy committee. 4 I do that often in collaboration with the gentleman, the other 5 medical director who sits on our policy team and do that 6 routinely. 7 information that I have found and he has gone over, we have 8 actually implemented some policies, probably three or four 9 changes in a relatively short time. 10 11 And in the three years I have been there, based on That were done on the off years. Q. Okay. Why does the medical policy committee use 12 such a rigorous review process to evaluate its medical 13 procedures and its policies? 14 A. Well, we feel, Blue Cross has an obligation to 15 their members, the patients, to provide evidence-based best 16 practice treatments, procedures so that the, yeah, they can 17 get the best care they can. 18 19 Q. Does Blue Cross/Blue Shield of Montana, under its policies, does it cover all services? 20 A. No. 21 Q. How does it determine what services are covered 22 23 and what services are noncovered services? A. We first always look toward contract. If there 24 are certain exclusions in contracts, then they cannot be 25 covered. Then if there is not a specific policy, we look at 259 1 the literature, we investigate, try to determine whether it is 2 standard practice, if it's community practice, and make our 3 determinations. 4 Q. Okay. Does Blue Cross/Blue Shield Montana cover 5 experimental, investigational or unproven medical 6 technologies or services? 7 A. No. It's a contract language. 8 Q. So that's an exclusion that's in every plan? 9 A. Yes. 10 Q. And how do you determine whether or not a service 11 falls within that category of experimental, investigational 12 or unproven? 13 A. By the method we discussed or I discussed 14 initially regarding how the policies are made. 15 if there is not a specific policy, we do literature research 16 ourself and spend time on those same sites. 17 other programs up-to-date. 18 Review, a number of sites that we go to that we look at the 19 information that is presented. 20 Q. Okay. And if again, Also we have You know, Med Publishing, Med And if a treatment is still in an 21 experimental, investigational or unproven stage, is it 22 considered to be evidence of a best practice? 23 A. No. 24 Q. And why not? 25 A. Because it hasn't been rigorously tested. 260 1 Q. Okay. If a service is not a covered service 2 under your plans, does that mean the Blue Cross/Blue Shield 3 Montana has denied treatment to its members? 4 A. No. 5 Q. And why not? 6 A. Patient members are always able to obtain the 7 services that they or their physician deems necessary. 8 Blue Cross/Blue Shield of Montana, using our policies, we are 9 just determining what we will cover and what we will not. 10 11 in no way do we say you cannot have this treatment. Q. So your determination is what services 12 Blue Cross/Blue Shield will pay for because of the covered 13 benefit under the plan versus what you will not pay for 14 because it is a noncovered service. Would that be accurate? 15 A. Correct. 16 Q. So you are not determining, you are just 17 determining payment status? 18 A. Correct. 19 Q. If a treatment is classified as experimental, 20 investigational or unproven, how does that, how does that 21 treatment evolve? 22 make it a covered benefit, to make it standard practice. 23 But A. How do you change that treatment status to As more and more data is available, more studies, 24 more physicians adopt the treatments, you see it more on the 25 national level rather than just certain clinics; then it 261 1 starts falling into the realm of more of a standard practice. 2 Q. Is there a hierarchy of review or studies or 3 medical literature that needs to be published that helps you 4 make those decisions? 5 A. Yes. 6 Q. Can you describe that for me please? 7 A. Yes, I can. The bottom here is anecdotal 8 opinions, then the next you start looking at observational 9 studies. 10 11 12 13 I don't know if you can indulge me for a second, Judge. THE COURT: I am following you so far. I understand what those two terms mean. THE WITNESS: I think for me, I am an example 14 person so that's the only reason I was going to give you an 15 example of other types of observational studies. 16 17 THE COURT: I think I understand what an observational study is. Thanks. 18 THE WITNESS: Okay. Sure, I'm sorry. 19 And then there is randomized control trials, there 20 is -- then if after there has been a number of those type of 21 trials, there is what's called meta-analysis, where they are 22 actually taking all the data from a variety of these studies 23 involving with particular treatment and doing statistical 24 analysis of those. 25 again they are taking as many articles that they can find out Also there is systematic reviews where 262 1 in the literature and then making critiques of those. And 2 those latter two are really the top level, so to speak, 3 studies. Those are the top level studies. 4 5 6 BY MS. BEATTY: Q. So what kind of combination of studies in this 7 list that you just described is necessary for a treatment to 8 move from the unproven to proven or standard of practice 9 category? 10 A. 11 12 13 14 We are going to at least look for randomized control trials. Q. And can you please, for our benefit, could you please describe what a randomized control trial is? A. Well, it was somewhat alluded to by Dr. Elliott, 15 but essentially, you are taking patients, a group of patients 16 with a particular symptom or problem, you randomize, some will 17 receive the treatment, some will not. 18 meaning the people who are doing the study don't know who is 19 getting the treatment versus who is not getting the treatment 20 and then compare the results. 21 Q. Okay. It's usually blinded, And along these lines, what's an 22 observational study briefly? 23 heard some of this already but in your opinion, what's an 24 observational study? 25 A. Because I know the Court has There is really not a lot of controls. It's just 263 1 looking at something. Like I said, if I quickly say, for 2 example, you could have the hypothesis that smokers have more 3 cancer than nonsmokers, that's your hypothesis. 4 observational, study you would go out get a bunch of smokers 5 and nonsmokers. 6 that. 7 lung cancer. 8 have more so your observation is that your hypothesis 9 initially was true. An You may not control any other variables, just There are going to be some nonsmokers who also have Hopefully -- Well, you will find that smokers But it doesn't, there is so many other 10 variables that you have to go further so that's kind of the 11 initial step and then you want to go to the next step and 12 start getting more detail and having more controls and also 13 controlling for the variables. 14 Q. Okay. Are observational studies alone sufficient 15 to change the status of the medical treatment from the 16 unproven category to the proven or standard of practice 17 category? 18 A. No. 19 Q. Why not? 20 A. They are just not rigorous enough testing. 21 are just that. 22 unless they are controlling variables, you can't make 23 statements. 24 25 Q. They are not controlling the variables. They And So why is it important to follow that process of, you know, as a pyramid of procedures you just described, why 264 1 is it important to follow that process when you are 2 evaluating new technologies? 3 A. To protect the patients. 4 Q. How does that review protect the patients? 5 A. Well, one, you will know if the treatment works. 6 Also then you will often have, whether or not there are side 7 effects, untoward problems with it, and often when you have, 8 say, a randomized control trial, if it's some new medication 9 for example, this often happens, you will have a new 10 medication, they maybe only have a pull of, say, 3,000 people 11 and overall, that's not a lot. 12 step back sometimes and you actually look at the observation 13 study because people start observing and say, "hey, well, this 14 patient has this," and then you gather another, more 15 information in that hones in on that randomized controlled 16 trial and you just obtain more and more data to make sure the 17 science is good and valid. 18 of this is to diminish harm. 19 down the harm. 20 Q. Then as it goes actually a And like I said, the whole point You know, you really want to cut If your medical policy committee reviews a new 21 treatment and decides over a period of time that enough is 22 out there to move it from the unproven category to the proven 23 category, does your committee amend its policies to allow 24 that new treatment to be deemed a covered benefit? 25 A. Yes, as soon as we find out. Sometimes we even 265 1 have what's called best processes, which is the information is 2 there, but because the policy team hasn't put it in proper 3 legal terms or whatever, it hasn't been written. 4 will go ahead and start allowing that procedure, even until we 5 get the official policy, we will start doing that. 6 Q. Well, we Did you review or investigate whether the APT 7 treatment we have been discussing for a couple days have been 8 subjected to any of this kind of rigorous scientific review? 9 A. Yes. 10 Q. What did you, what did you conclude from your 11 research? 12 A. That there is not enough information out there. 13 We, I found, I did a literature search, looked on the sites I 14 mentioned before and I found basically one article, one that 15 Dr. Elliott was one of the authors of. 16 studies. 17 There is not a lot of objectivity in the data and there is 18 also a little bit of bias. 19 manufacturer of a drug is the only person who has done the 20 study, you kind of question that and this particular article 21 that is out there, the authors appear to be all related to 22 Trina Health in some fashion. 23 validity -- or well, at least my accepting of that as far as 24 being an acceptable treatment. 25 Q. They are observational There is not -- a lot of the results are subjective. We look for bias. If the So that also diminishes the Were you able to locate any independent 266 1 scientific studies about APT other than this one study that 2 Dr. Elliott discussed? 3 A. No, ma'am. 4 Q. Were you able to find any other scholarly 5 journals or medical publication articles on APT besides the 6 one we were discussing? 7 A. No, ma'am. We also looked or I also looked at the 8 various specialty societies and went even a step further, not 9 just even the American ones, but I looked at Europe, Japan -- 10 Well, when I say "Europe", Britain, Netherlands, and looked 11 for this particular treatment, you know. 12 expect to find necessarily so I also looked under Microburst 13 Insulin Infusion because often that's, rather than using the 14 name, we use, you know, the trade name we will use actually. 15 16 Q. Okay. The APT, I didn't Were you able to find in any evidence that there was some independent clinical trials conducted on APT? 17 A. No. 18 Q. Were you able to find any studies with any kind 19 of control group component or independent observers for APT? 20 A. No. 21 Q. Were you able to find any evidence of prospective 22 trials or prospective studies for APT? 23 A. No. 24 Q. Were you able to find anything other than 25 Trina Health's marketing materials? 267 1 A. Other than the one study, no, just Trina's. 2 THE COURT: What was the last sentence? 3 THE WITNESS: No, other than the one article that 4 Dr. Elliott, we have been discussing and then everything else 5 was Trina Health marketing material. 6 THE COURT: Thank you. 7 8 BY MS. BEATTY: 9 Q. Did you conduct a search or contact your 10 colleagues at other insurance companies to determine whether 11 APT was a covered service under any of those other policies? 12 A. Only the medical directors, as far as a personal 13 reaching out. I reached out to the other medical directors of 14 the plan of HCSC and there was none. 15 pull, one part of the thing we look at is what other companies 16 are doing. 17 probably the easiest ever to find -- and Blue Cross -- and 18 look to see specifically if the use of APT was mentioned. But then also we do So we do pull -- United and Aetna's policies are 19 Q. What did you find when you searched those? 20 A. Just the two, Blue Cross of Alabama and then 22 Q. Anthem or Aetna? 23 A. I mean Aetna. 24 Q. And what did their policies say? 25 A. I actually brought the policies with me. 21 Anthem. Sorry. So but 268 1 anyway, they basically put in APT with all the others, CIIIT, 2 PIVIT, OIVIT, they were all equally. 3 4 Q. And was that a covered, was APT a covered benefit under those plans that you found? 5 A. No, ma'am. 6 Q. Is APT a covered benefit under any of the other 7 five plans within the HCSC family? 8 A. No, ma'am. 9 Q. What states are covered under the HCSC umbrella? 10 A. Illinois, Oklahoma, Texas, New Mexico and Montana. 11 Q. Did you do any research into what, I'll use the 12 We all use the same policy. acronyms CIIIT, PIVIT or OIVIT? 13 A. Yes. 14 Q. And are any of those procedures a covered benefit 15 under Blue Cross/Blue Shield Montana's plan? 16 A. No. 17 Q. Do you have a medical policy on those specific 19 A. Yes. 20 Q. And is that the same medical policy we have 18 21 plans? discussed the last couple of days? 22 A. Yes. 23 Q. Why does Blue Cross/Blue Shield Montana exclude 24 25 or find that those are noncovered services? A. Because again the literature is not there. There 269 1 is no, the articles that are out there do not show an even -- 2 Sorry. 3 nonequivalent. 4 PIVIT, et cetera, isn't, it's not any different than the 5 current treatment and there is just not enough literature out 6 there supporting that it's beneficial. 7 8 Struggling with my words -- a nonsuperiority or a Q. In other words, the treatments that the CIIIT, Do you have a baseline understanding of what CIIIT, PIVIT and OIVIT are? 9 A. Baseline, yes. 10 Q. What do they do? 11 A. Well -- 12 MS. MacLEAN: Objection, your Honor. He's now 13 giving expert testimony in and area that's not been built up 14 for him to be an expert under Rule 702. 15 THE COURT: Thank you. I am going to overrule. 16 THE WITNESS: 17 just put it in simple terms for me. 18 to reset the metabolism or glucose through the liver by 19 giving insulin. 20 unclear. 21 been studies, so to speak, talking about the mechanism of 22 action in humans. 23 microbiology, so that's my basic understanding though is that 24 you are trying to, the simplest way I look at it is reset the 25 liver to metabolize. My basic understanding, I am going It's that you are trying When you read their articles, it's kind of Just like our policy says, there has not really It's through animal studies, through 270 1 BY MS. BEATTY: 2 3 Q. And are all these types of treatments, are they all insulin infusion treatments of one kind or another? 4 A. Yes. 5 Q. Do you have a basic understanding of what APT is? 6 A. Yes. 7 Q. What is your understanding of what it does? 8 A. To me, it's basically trying to end up at the same 9 place. There is different methods. Again if I may use a 10 couple of analogies: one, a car. 11 transmissions; you have manual transmissions. 12 different in the mechanisms but essentially, they are trying 13 to do the same thing, which is get you down the road. 14 example from the medical field that I think of is 15 hypertension. 16 blood pressure. 17 give them a variety of oral medications, but each of the oral 18 medications may have a different mechanism of action. 19 other words, one might work on the kidney, one might work in 20 the heart. 21 that place, which is control of your blood pressure. 22 And from what I see with APT and OIVIT is there may be some 23 minor differences but essentially, they are all trying to get 24 to the same place. 25 Q. You have automatic They are Another There are multiple ways of treating somebody's You can give them IV medications, you can In But essentially, they all are trying to get you to Is APT another form of insulin infusion 271 1 treatment? 2 A. Yes. 3 Q. Did you or the committee reach any decisions or 4 make any determinations about whether or not APT should fall 5 within the billing code that is allocated to OIVIT, CIIIT and 6 PIVIT? 7 A. I can't speak for the committee honestly but I 8 personally have reviewed it and looking at the specifics of 9 the code, when you look at the definition of the code, yes, it 10 does. It fits in the code definition. 11 Q. Okay. Do you have the code G9147 memorized? 12 A. No, ma'am. 13 Q. And I don't believe that the actual code has been 14 placed in the record so with the Court's indulgence, I'd like 15 to read it to you so that you have an understanding of what 16 it is. 17 THE COURT: 18 MS. BEATTY: Do you have -I do. The only copy I have has some 19 handwritten, handwriting on it. 20 the record with the handwriting, if that's okay with you. 21 22 23 THE WITNESS: I am happy to put that into I apologize, your Honor, I wrote something. THE COURT: That's all right. We could probably 24 substitute it too. Has Ms. MacLean seen it? I would rather 25 just read the language than have it read because I am not 272 1 going to absorb it. 2 MS. MacLEAN: Your Honor, I don't know this has 3 been verified by a coding expert and I don't know that this 4 is the correct language for it. 5 THE COURT: All right. Well, what I am going to 6 ask each of you to, in your briefing, just attach the correct 7 code so that I can read it. 8 point about what the codes said, that's fine but reading it 9 into the record is not going to help me any. 10 11 MS. BEATTY: And if you want to make your That's fine, your Honor. I do have a coding expert who can discuss this as well. 12 THE COURT: All right. 13 14 15 BY MS. BEATTY: Q. Dr. Pujol, based upon your understanding of what's 16 in that code, that G09147 code, is APT appropriately coded in 17 that code section? 18 A. Yes. 19 Q. And why is that? 20 A. Because if you look at the code, it basically 21 talks about an insulin infusion, whether pulsatile or 22 continuous and then uses certain measurements to, along with 23 that and they give you a variety of ones you use, but it 24 includes all that. 25 pulsatile or continuous infusion of insulin, and that's, to In APT, just like I said, etc., all are a 273 1 2 me, the simple part of it. Q. Okay. Do you know, are you the best person for 3 me to ask questions to about how Trina billed their services 4 to Blue Cross/Blue Shield or billed APT services? 5 A. Not, no. 6 Q. Would a more appropriate person be Jamie Smith? 7 A. Yes. 8 Q. Did you reach any conclusions about APT and 9 10 11 I am not aware of how they bill. whether it fell within Blue Cross/Blue Shield's experimental, investigational and unproven conclusions? A. Yes. My conclusion was that it would, based on 12 the fact that there is again only one article out there and if 13 you look, for example, one of the conclusions about peripheral 14 neuropathy where there are methods in medicine where you can 15 actually test someone's -- And, in fact, it's a standard of 16 practice to test someone with diabetic, their sensation, for 17 example, on their bottom of the foot. 18 simple, it's a monofilament, comes in different sizes and as 19 you lose your ability to feel, you have to use a larger size 20 and that's very easy to do, very simple. And there is, it's very 21 And in this particular study, the results actually 22 involved just a subject, someone saying it's better, you know, 23 that they are better. 24 observation study, even below that is anecdotal or just 25 people's opinion and when you are asking someone how does it And just as I mentioned before with 274 1 feel, that's not really objective. And so I would not 2 consider this one article to be sufficient evidence to say 3 that it's -- I don't like to keep saying experimental, EIU, 4 unproven. 5 Q. When did it come to your attention that Trina may 6 have been using an improper code for billing of its services 7 for APT? 8 A. Well, that actually was brought to me by Jamie. 9 Q. By Jamie? 10 A. And my colleague, the other medical director. 11 Q. Okay. Did you review -- And your Honor, I will 12 put her up next so she can discuss the process -- but after 13 you, did you talk to her about her findings and the results 14 of her investigation? 15 A. Um, yes. 16 Q. And after talking with her, what did you conclude 17 18 or what actions did Blue Cross/Blue Shield Montana take? A. Well, their letter that was sent and that was 19 trying to, like I say, this is the code you need to be 20 billed, it seemed to be a practice that -- I don't think it's 21 always -- Well, sometimes people will unbundle things and we 22 won't pick up the, that this procedure is necessarily 23 experimental when you use all those codes that are normally 24 covered. 25 that, and they will say since it was determined this was going But if it would be billed properly, you will notice 275 1 2 on, then the letter was sent out. Q. So is it fair -- I just want to try and 3 understand your testimony -- is it fair to say that because 4 Trina was billing APT services using multiple different 5 smaller codes, if you will, or codes for unbundled services, 6 you weren't aware for quite some time that they were actually 7 billing an APT service? 8 A. Correct. 9 Q. Okay. And when they billed under those unbundled 10 codes, were those codes processed and paid under 11 Blue Cross/Blue Shield's system? 12 A. Yes. 13 Q. And would they have been paid had they been 14 billed in the G9147 code? 15 A. No. 16 Q. What directives did you issue to Trina in the 17 18 April 2017 letters? A. 19 Well, actually I did not personally. THE COURT: And I have read the letters. 20 21 22 BY MS. BEATTY: Q. Okay. So let me cut to a slightly different 23 question then. 24 providers to stop providing APT service to its patients? 25 A. Did you direct Trina or any of its employee No, would not, we would not do that. 276 1 2 Q. A. No. We never tell people not to use their judgment on treatment. 5 6 Did you prohibit the patients from getting APT services from Trina? 3 4 Okay. Q. Did you ever tell patients to not get APT services from any providers? 7 A. No. 8 Q. Did you ever prevent the plaintiffs from 9 10 receiving diabetes treatment that did meet the standard of practice and would otherwise fall within a covered service? 11 A. No. 12 Q. Did you direct Trina to close its doors? 13 A. No. 14 Q. Did you direct Trina to stop providing APT 15 services? 16 A. No. 17 Q. Did you prohibit Trina from billing 18 Blue Cross/Blue Shield Montana for APT services? 19 A. No. 20 Q. Dr. Pujol, do you know who creates the CPT 21 codes that are used? 22 23 American Medical Association creates the CPT Q. And does the CMS also have a version of it's codes. 24 25 A. codes? 277 1 2 A. G code you are talking about. 3 4 Well, they produce the HCPCS code, which is the Q. And so who determines what set of services should be bundled together into a code? 5 A. My understanding, it's CMS. The AMA, on some of 6 their coding, also will say that you cannot bill these two 7 services together. 8 Q. 9 decision? 10 A. Never. 11 Q. Does Blue Cross/Blue Shield Montana create its 12 So that's not a Blue Cross/Blue Shield Montana own codes? 13 A. No. 14 Q. If Trina or anybody else thought that APT should 15 be coded separately from an OIVIT, CIIIT, PIVIT, can it ask 16 Blue Cross/Blue Shield to create a new code for it? 17 18 19 20 A. They could, they could ask but we would not do Q. Who should they ask if they wanted a separate that. code for that service? 21 A. CMS or the AMA. 22 Q. To your knowledge, did Trina do so? 23 A. No. 24 25 MS. MacLEAN: Objection, your Honor. I'm going to speak that in that, he has no qualifications to say what 278 1 Trina has or has not done. 2 THE COURT: Well, I think your hearsay objection 3 is a little late. I think that's what you are objecting to 4 so I am going to overrule. 5 6 7 8 BY MS. BEATTY: Q. Did you consider the materials that Trina submitted to Blue Cross/Blue Shield Montana with its letters? 9 A. Yes. 10 Q. Did you reach any conclusions about whether or 11 not the materials they submitted would change your mind? 12 A. They did not change my mind. 13 Q. And why was that? 14 A. They were, as I alluded to before, that they are 15 just not sufficient. 16 being an observational study with not a lot of objective data 17 is not sufficient and then the others are more marketing 18 materials. 19 Q. Okay. There is only the one article, which it Were you present, I believe you testified 20 you were present for Dr. Elliott's testimony and his cross- 21 examination? 22 A. Yes. 23 Q. All right. So you heard his testimony concerning 24 his article that was published, one article that was 25 published? 279 1 A. Yes. 2 Q. What's the significance of a peer-reviewed study? 3 A. Well, you have other people looking at the 4 information that you are presenting. 5 review, it's a little higher standard than if you just publish 6 it in a journal that does not have that. 7 increases the validity but by having a peer-reviewed article, 8 it doesn't mean that it's necessarily totally valid. 9 often allow it for -- as a starting point, for example, to 10 consider further treatment -- Or excuse me, further study. 11 Q. And when you have peer It does not, it They Do you recall Dr. Elliott's testimony that the 12 American Diabetes Association guidelines for treatment of 13 diabetes should not be considered a publication of a standard 14 of practice for diabetes treatment and is merely information? 15 A. Yes. 16 Q. Do you degree with him? 17 A. No. 18 Q. Why not? 19 A. The guidelines are placed there for physicians to 20 use as -- It's a term but as a guideline to follow practices. 21 It's the, what you would be expected to generally do. 22 they are called guidelines because every person is an 23 individual and they have, there may be multiple factors, 24 comorbidities, things that may make you deviate from those 25 guidelines. Now, But essentially, those guidelines are what you 280 1 2 are expected to at least walk that path. Q. Do physicians rely upon guidelines published by 3 that society and other similar societies to set practice 4 standards? 5 A. Yes. 6 Q. If physicians were not able to rely upon those 7 kinds of guidelines and recommendations, what would they 8 consider to set practice guidelines -- or excuse me, to set 9 practice standards? 10 A. Part of the reason the guidelines -- and I am 11 answering your question indirectly -- part of the reason the 12 guidelines are there is because a general, a practicing 13 physician doesn't have time to read all the articles. 14 practiced outside the insurance industry for 30-some years 15 and I did not have time to review every article so these 16 guidelines are the experts in the field who have done the 17 literature research, who have looked at the research articles 18 and come up with what would be considered, you know, best 19 practice, evidence-based best practice, which is where we all 20 are trying to, what we all are trying to do these days as 21 physicians. 22 Q. I Does your medical policy committee also consider 23 such guidelines when determining whether treatments are 24 experimental, investigational or unproven? 25 A. Always. If you look at our policies -- and I 281 1 won't say 100 percent -- but almost all of them have some 2 reference to a specialty society. 3 4 MS. BEATTY: All right. Thank you, Dr. Pujol. I am going to leave you there to cross-examine. 5 THE COURT: Thank you. 6 Ms. MacLean. 7 MS. MacLEAN: Yes, your Honor. 8 9 CROSS-EXAMINATION 10 BY MS. MacLEAN: 11 Q. Good afternoon, Dr. Pujol. I am going to grab 12 another document but I will throw down some questions and 13 when we can get it, we will get it. 14 15 16 17 You said that you don't -- You are a general practitioner correct? A. Well, actually, I am board-certified in pediatrics -- 18 Q. In pediatrics. 19 A. But I practice a variety -- 20 Q. You are not an endocrinologist? 21 A. I am not. 22 Q. And you have never treated a person with the 23 Harvard Protocol or the treatment known as OIVIT, correct? 24 A. No, ma'am? 25 Q. You have never seen the treatment performed? 282 1 A. No, ma'am. 2 Q. I am going to put a stack of documents in front 3 of you to make it easier for me just to go through them, if 4 that works for you. 5 6 MS. BEATTY: Your Honor, I would like to see those documents before. 7 (Off the record.) 8 THE COURT: 9 10 admitted documents, and you can tell Ms. Beatty that that's -- 11 12 Just to be clear as long as they are MS. BEATTY: As long as you tell me what they are, yep. 13 THE COURT: All right. So the record, just to be 14 clear the record should reflect Ms. MacLean has shown them to 15 Ms. Beatty. 16 You may put them in front of the witness. THE WITNESS: Thank you. 17 18 BY MS. MacLEAN: 19 Q. So let's first take a look at Exhibits 8 20 and 10. 21 those, sir? 22 23 24 25 These are Petition Exhibits 8 and 10. THE COURT: of him. Can you see Yes, he says he has them in front 283 1 BY MS. MacLEAN: 2 Q. 3 You testified, correct, that you provided the basis for these letters; is that correct? 4 A. I am not sure I follow. 5 Q. Did you provide the basis of the determinations 6 7 that were in these letters? A. No, that's not what I testified. I helped -- The 8 team determined whether or not the treatment, the APT, would 9 be considered similar enough to CIIIT. 10 part of the legal team. 11 networks that sent this out. But I don't, I am not I am not part of the provider 12 Q. I'm sorry? 13 A. Just it's not mine. 14 Q. What you are telling me is you came up with a 15 decision that APT/MII was substantially similar to the other 16 treatments in your CIIIT policy, correct? 17 18 MS. BEATTY: That mischaracterizes his prior testimony. 19 20 Objection. THE COURT: I think he already answered so overruled. 21 22 BY MS. MacLEAN: 23 Q. What was your answer to that? 24 A. I -- yes. 25 THE COURT: I didn't hear it. And also, as I have in the past, I 284 1 will rely on the record and I think I know what the record 2 says. 3 4 BY MS. MacLEAN: 5 Q. 6 And you have never seen or performed the APT/MII treatment, have you? 7 A. No. 8 Q. You never went to the Trina Health of Montana 9 Clinic to see what the treatment looked like or what was 10 being performed? 11 A. No. 12 Q. And you have no first-hand knowledge of the 13 treatments that are being addressed, both in this CIIIT 14 policy and APT/MII, correct? 15 A. No, that is not correct. 16 Q. You don't have first -- you do have first-hand 17 18 knowledge? A. I have first-hand knowledge in the sense that I 19 can read articles and I can read literature, research, and 20 that is my job. 21 have never performed neurosurgery. 22 cardiac surgery but I can read literature and that's what my 23 job is to do is to review literature and review our policies, 24 which I can do. 25 Q. I do not -- I review all kind of cases. I I have never performed It doesn't make you an expert on these 285 1 2 treatments, does it? A. I am not trying to say I am an expert. My job is 3 not to be an expert but to interpret our policies and to look 4 at research. 5 6 Q. And as an employee of Blue Cross/Blue Shield of Montana? 7 A. Yes. 8 Q. And your employer has a financial interest in 9 this matter, doesn't it? 10 A. Yes. 11 Q. And your employer directs you to make 12 determinations for the financial interest of the 13 organization, correct? 14 A. No. That's actually -- That's against the law. We 15 do not take into consideration costs for our decisions. 16 take into consideration what is best, in the best interest of 17 the patient. 18 surprised -- 19 20 Q. We I can provide examples where doctors have been I don't need examples, but thank you. I don't think the Judge would appreciate that today. 21 A. Okay. 22 Q. So let me get this straight, you decided that 23 APT/MII was experimental, investigational and unproven based 24 upon its relation to other treatments identified in medical 25 policy, Med 201.028, correct? 286 1 A. Not exactly. 2 Q. Well, that's what it says in the letter, correct, 3 4 in the letters? A. I, I did not write this letter, okay. When I 5 review, I reviewed and said yes, I think this treatment 6 similar but at the same time, I said that even independently, 7 if you want to think of APT as its own stand-alone entity, 8 different than CIIIT, it would still be considered 9 experimental, investigational so -- 10 Q. 11 12 MS. BEATTY: Ms. MacLean, I would like you to let him finish his answer before you move to the next question. 13 14 So would you show me where that is? THE COURT: Yes. I would like everyone to let everyone finish talking before the other person talks again. 15 THE WITNESS: I -- 16 17 BY MS. MacLEAN: 18 Q. 19 Would you just answer my question? THE COURT: But hang on. 20 you just interrupted me. 21 MS. MacLEAN: 22 THE COURT: 23 THE WITNESS: He was just talking and I understand. Finish your answer please. Well, my -- When we look at 24 information, when something is put in front of me, I make a 25 determination. Yes this, I believe this is similar enough 287 1 but there are times, since it doesn't directly say in our 2 policy "APT", I go to other sources including other health 3 plans, I go to literature and I look and review it so even 4 though I believe it is -- and as, you know, I believe it's 5 similar enough that it matters but if you even put that aside 6 and say the policy does not apply, I would still consider APT 7 EIU based on the what I researched, which would then be a 8 contract also, a contract exclusion. 9 Q. So where exactly is, in the plan that's in front 10 of you, which is Exhibit 2 to the petition, it doesn't state 11 that APT/MII -- 12 A. No. I'd have to look through for here for the 13 EIU language because every, every benefit book has an 14 exclusion for experimental, investigational and unproven. 15 Q. 16 experimental -- 17 A. 18 I understand but it doesn't say APT/MII is We -- There are so many -THE COURT: Hang on, hang on, hang on. We have 19 got to take our time. 20 think, is where you want to at least start with. 21 least, defines experimental, investigational, unproven. 22 And I will tell you Page 2-200, I THE WITNESS: That, at Yes. 23 24 BY MS. MacLEAN: 25 Q. And in that page, it does not state that APT/MII 288 1 is not there, is it? 2 A. No. 3 Q. Okay. 4 Let's take a look at the medical policy, med policy 201.208. I think that's attached to -- 5 A. I am familiar with the policy. 6 Q. Petition Exhibit No. 7. 7 A. Okay. 8 THE COURT: 9 THE WITNESS: Here it is. So you see Exhibit No. 7, Doctor? Yes, that's what I am looking 10 through and I found what I believe is the middle part. 11 it is, yes. There 12 13 BY MS. MacLEAN: 14 Q. Do you see where that is? 15 A. 421? 16 Q. Yes. 18 A. Yes. 19 Q. APT/MII is not referenced in this policy, is it? 20 A. No. 21 Q. Where in this policy does it say that 17 Petition Exhibit 7-421, do you see that sir? 22 substantially similar or substantially different treatments 23 do or do not apply to this policy? 24 25 A. That's a medical determination. specifically in this policy. It's not 289 1 2 Q. A medical determination that would be made by an expert in the area of these treatments, correct? 3 A. No. 4 Q. Just random people? 5 A. No. Any physician, as I think Dr. Elliott pointed 6 out, any physician has the capability of evaluating literature 7 and looking. 8 capable of looking. 9 Q. You may not provide the service but we are That's part of our training. So let's take a look at the basis for this 10 medical policy, the rationale. And we talked about that 11 before and I think you have heard, read in on the third page 12 of Page 9 of this medical policy. You see that, right, sir? 13 A. I am not -- Which, which number are you talking -- 14 Q. It's 7-423, I think, in the one you have. 15 A. Yes. 16 Q. And where it says on the bottom of the paragraph 17 of rationale, the first paragraph, "no studies were 18 identified that investigated the proposed mechanism of action 19 of CIIIT". 20 THE COURT: Slowly please. 21 MS. MacLEAN: Sorry. 22 23 BY MS. MacLEAN: 24 Q. Do you see that? 25 A. Yes. 290 1 Q. That's not true of the study or I should say, the 2 study that Dr. Elliott did does show the proposed mechanism 3 of action of APT/MII treatments, doesn't it? 4 A. No, it does not. 5 Q. How can you say that, sir? 6 A. Because it's not in there. 7 There is no mechanism of action in his study whatsoever and it's just not there. 8 Q. So explain that, sir. 9 A. Well, you are asking me to explain what's not 10 there. 11 action of how this works. 12 what it's doing but there is no proposed mechanism of action 13 in his study either. 14 show you. 15 Q. 16 17 In other words, you are looking for the mechanism of If I had a study, I would be happy to If he disagrees with you, he is the expert in this, correct? A. Well, I would -- 18 MS. BEATTY: 19 THE COURT: 20 MS. MacLEAN: 21 In his article, there is methods on Objection. Argumentative. Sustained. Your Honor, I am trying to eliminate questions to the extent we don't need them. 22 THE COURT: Thank you. 23 24 BY MS. MacLEAN: 25 Q. Do you have a policy that says what the 291 1 definition of substantially similar is in relation to 2 treatments covered by policies? 3 A. We would not have a policy on that, no. 4 Q. So you don't have a definition of the term 5 6 'substantially similar'? A. No. We never (indiscernible). 7 THE COURT REPORTER: 8 MS. MacLEAN: Related to coverage. 9 THE WITNESS: I started to say, "but"; I just left 10 No what? it at the "but". 11 I was answering the court reporter. 12 THE COURT: All right. Sorry. I understand you were and 13 I am trying to protect the court reporter and thereby, both 14 party's records. 15 down, take your foot off the gas and wait for each other 16 to talk. So if we could just get everyone to slow 17 18 BY MS. MacLEAN: 19 Q. And you can't show me anywhere other than in this 20 opinion you brought in today from you that there is a plan or 21 policy that specifically excludes APT/MII, correct? 22 MS. BEATTY: 23 THE COURT: 24 25 Objection. Sustained. Asked and answered. 292 1 BY MS. MacLEAN: 2 Q. 3 If you take a look at the policy, the medical policy that we were just looking at, sir. 4 MS. BEATTY: Is that Exhibit 7? 5 MS. MacLEAN: 6 THE COURT: It is under Exhibit 7. 7-421. 7 8 BY MS. MacLEAN: 9 Q. Do you notice that this is not a -- And this is 10 the policy that was sent with the cease and desist letter so 11 do you recognize that? 12 A. Yes. 13 Q. This is not a Blue Cross/Blue Shield of Montana 14 policy, is it? 15 A. Yes. 16 Q. At the time that it was sent it wasn't, was it? 17 A. Um, the Blue Cross/Blue Shield of Montana uses 18 HCSC policies. Those are our policies. 19 Q. So they are one and the same? 20 A. Yes. 21 Q. Then why is there a different policy adopted in 22 July of 2017 that says "Blue Cross Blue Shield of Montana" 23 specifically on it? 24 25 A. They sometimes will -- They have been trying to be consistent and that's more just an enterprise -- I guess I 293 1 don't want to say bookkeeping but trying to have it so that 2 it says that so there is no confusion to people who may not 3 be familiar that Blue Cross/Blue Shield of Montana is part 4 of HCSC. 5 Q. So this policy committee that you were talking 6 about, it's a group of people from different states that's 7 not based in Montana? 8 MS. BEATTY: 9 THE COURT: Objection. Asked and answered. Sustained. 10 11 BY MS. MacLEAN: 12 Q. 13 One of the individuals on that policy board is from Texas? 14 A. Yes. 15 Q. And are you aware that Texas pays for APT/MII 16 under the code submitted by Trina Health of Montana, LLC 17 prior to this cease and desist letter being sent? 18 19 20 21 A. I have no personal knowledge what Blue Cross/Blue Shield Texas does other than what was said in court. Q. You said today that everybody pays and reviews these claims consistently, correct? 22 A. We try. 23 Q. And that would be inconsistent, wouldn't it? 24 A. Well, it's only inconsistent in that if, in Texas, 25 Trina Health is also billing the same way they did in Montana 294 1 and it's not recognized, then yes, they would go through just 2 like it did here in Montana. 3 code, then things fall through. 4 If you are not using the proper There is, as you are probably aware, 10,000-plus 5 codes. 6 day -- and I would have to defer to some other people in my 7 organization -- claims go through Blue Cross of Montana or, 8 well, HCSC so we cannot look at every individual claim nor can 9 we review every medical record. 10 We cannot -- and a million literally, I think, in a Q. And you understand there is a dispute as to 11 whether or not you have decided there is a proper code of the 12 G9147 in relation to APT/MII, correct? 13 A. Correct. 14 Q. And you acknowledge that Dr. Elliott has the 15 expertise as to APT/MII to opine on whether or not it's 16 experimental, investigational or unproven, correct? 17 A. No. 18 Q. Why not? 19 A. Because this is a treatment he has given, he has 20 written the article and it is his opinion that it is not EIU. 21 But in general medical circles, the literature just doesn't 22 support it. 23 treatment, but I would object also, his background, for 24 example, is OB-GYN -- 25 Q. And so anyone can say they are an expert in some I'm sorry. I'm going to interrupt but you are not 295 1 answering my question directly. 2 MS. BEATTY: Judge, I think he is trying to answer 3 the question and if Ms. MacLean doesn't like his answer, I 4 can't help that. 5 6 THE COURT: but sustained. 7 MS. BEATTY: 8 THE COURT: 9 I am not sure what that objection was Argumentative. Sustained as argumentative. he answered the question. 10 MS. MacLEAN: 11 THE COURT: 12 I think Okay. Can I ask another question. You can ask another question but I am, it's not going to help me for you to argue with him. 13 MS. MacLEAN: I understand, your Honor. 14 15 BY MS. MacLEAN: 16 Q. So what you are suggesting is that the only way 17 you would agree with Dr. Elliott is if they, there was a 18 clinical trial that potentially harmed people as Dr. Elliott 19 said could happen? 20 A. No. 21 Q. Because there is a peer-review article that shows 22 you exactly what you need to know as far as the efficacy of 23 this treatment, isn't there? 24 25 A. It's not what I testified to and what I will say again is it's not adequate to support continuation of this 296 1 treatment at a level that Blue Cross/Blue Shield would feel 2 comfortable reimbursing for because again our, part of my job 3 is to make sure that it's evidence-based best practice and 4 that has not been shown with this particular treatment. 5 until it is, no. 6 Q. 7 10 Where is it shown that it's not evidence-based best practice? 8 9 And A. It's, actually the burden is upon the person who is putting that proposal out. is not. It's not on us to show that it It's, the burden is on them. 11 Q. And what would make it not an evidence-based best 12 practice? 13 A. I'm sorry. 14 Q. What would make it not an evidence-based best 15 practice? 16 A. If I am understanding the question correctly, the 17 fact that there is not literature support, there is not 18 society support of this particular treatment, then it's not 19 evidence-based best practice. 20 Q. 21 Is that what your question was? There is literature to support it though. MS. BEATTY: Objection, your Honor. She's 22 badgering and argumentative and I think we've plowed this 23 ground. 24 25 THE COURT: Sustained. 297 1 BY MS. MacLEAN: 2 Q. 3 And so let's talk about you said your job really is to protect the patients? 4 A. Yes. 5 Q. And in this case, what would, how would not, how 6 would denying this treatment protect the patients? 7 A. Maybe I misstated the, what my job is. My job is 8 also to, we want to pay or cover treatments, medications which 9 are proven effective, proven not to cause harm, and that's 10 what we are trying to do. 11 Q. And -- In what way is, does this research article that 12 you have seen not show you that it's not proven to cause 13 harm? 14 MS. BEATTY: 15 THE COURT: 16 Objection. Sustained. outhouse several times on this. 17 MS. MacLEAN: Asked and answered. We have gone around the I understand your point. Okay. 18 19 BY MS. MacLEAN: 20 Q. 21 You have not identified any side effects that might cause an issue with this treatment, correct? 22 MS. BEATTY: 23 endocrinologist expert. 24 testimony. 25 THE COURT: Objection. He is not here as an That's beyond his scope of Sustained. I think we have covered 298 1 this. What he is here, as I understand it, is as a medical 2 director who is making decisions on coverage. 3 4 BY MS. MacLEAN: 5 Q. So what you are telling me, and I think what you 6 said before is you don't determine whether a treatment is 7 medically necessary? 8 9 10 11 12 MS. BEATTY: Objection. Mischaracterizes his prior testimony. THE COURT: Sustained. And the record speaks for itself and he has testified about that. MS. MacLEAN: If you are -- I guess I am not sure 13 where to go with this, your Honor. 14 THE COURT: I am not sure either but I think we 15 have hit just about every point multiple times. 16 him, 'so what you are telling me', and I think what you said 17 before is you don't determine whether a treatment is 18 medically necessary to which there was an objection, and I 19 think he has already testified that he and the committee make 20 that determination and make the coverage determinations. 21 MS. MacLEAN: You asked Your Honor, I was talking about 22 specific -- I think he actually testified to the opposite of 23 that when he was testifying on direct. 24 25 THE COURT: All right. I am going to let you ask that question once and then we are at 4:25, and I still have 299 1 questions to ask of lawyers and I think there is one more 2 witness to go. 3 4 BY MS. MacLEAN: 5 Q. When we are talking about treating specific 6 patients, who determines whether or not a treatment is 7 medically necessary? 8 A. That's part of my job, yes. 9 Q. Is it the job of the treatment, treating provider 10 11 to make that determination? A. My job is to determine whether it's medically 12 necessary according to our policies, according to contract 13 language, whether or not we will cover that service. 14 because a physician or provider says they think it's medically 15 necessary doesn't necessarily mean the insurance company will 16 have that same determination. Just And there is -- 17 Q. And you've said -- 18 A. I would just like to finish. That's why we say 19 you can always have whatever treatment your doctor and you 20 think is medically necessary. 21 22 23 Q. Whether or not it's covered is based upon the language of the plans, correct? A. 24 25 We just might not cover it. Yes. MS. MacLEAN: your Honor. Thank you. No further questions, 300 1 THE COURT: Thank you. 2 Ms. Beatty? 3 4 5 6 REDIRECT EXAMINATION BY MS. BEATTY: Q. Dr. Pujol, do you know the last time the medical 7 policy that we have been discussing, I think it's 7, on 8 Exhibit 7, do you know when the last time that policy was 9 renewed or updated? 10 A. 11 12 THE COURT: MS. BEATTY: I Yeah, I think it's in Exhibit 7. It's in Exhibit 7. 15 16 I am not sure it's in Exhibit 7. think it's Exhibit 4. 13 14 I'd actually have to look honestly. THE COURT: Oh, you are talking about the medical policy? 17 MS. BEATTY: Yeah, the medical policy, your Honor. 18 19 20 BY MS. BEATTY: Q. So it's Exhibit 7-412 is where it starts. And I 21 am just getting to the point of why was it issued under an 22 HCSC heading versus a Blue Cross/Blue Shield of Montana 23 heading. 24 interim? 25 A. Could it be that the policy was updated in the Yes, indeed it was because then they updated it 301 1 last year in June and it will be up -- And the way it works, 2 they are usually two or three months ahead so that they can 3 update it by the time June comes around so they are probably 4 looking at the policy again at the moment. 5 Q. And so was the updated policy that came out in 6 June 2017 was printed on a Blue Cross/Blue Shield Montana 7 letterhead rather than HCSC letterhead? 8 A. 9 MS. BEATTY: 10 11 Correct. THE COURT: That's all I have, your Honor. Thank you. Any follow-up within the scope of that? 12 MS. MacLEAN: 13 THE COURT: 14 May this witness step down? 15 MS. BEATTY: 16 THE COURT: 17 (Witness excused.) 18 THE COURT: You have one more witness, I believe? 19 MS. BEATTY: I do and I hope she will be brief. 20 THE COURT: 21 MS. BEATTY: 23 THE COURT: 25 Thank you. Thank you. All right. Yes. Thank you for your testimony, Doctor. All right. Thank you. I think we are all there. 22 24 No, your Honor. We'd like to call Jamie Smith. Ms. Smith, if you would just come forward, I will swear you in. 302 1 JAMIE SMITH, 2 called as a witness, and having been first duly sworn, was 3 examined and testified as follows: 4 5 6 THE COURT: Have a seat up here and if you will just pull that microphone close to you. Thanks. 7 8 9 10 11 12 13 14 DIRECT EXAMINATION BY MS. BEATTY: Q. Ms. Smith, could you please state your name and title for the record? A. My name is Jamie Smith. investigator. Q. Okay. I am going to hand you a copy of your 15 resume qualifying you. 16 THE COURT: 17 And you have given a copy to Ms. MacLean? 18 MS. BEATTY: 19 THE COURT: 20 I am a senior fraud Yes, yes. And you have already marked this as Exhibit 100. 21 MS. BEATTY: I did, yes. 22 23 24 25 BY MS. BEATTY: Q. Ms. Smith, could you please briefly tell me your educational background. 303 1 2 A. Are you referring to college or my work experience? 3 Q. Let start with college. 4 A. I attended the University of Montana for two Q. Okay. 5 6 7 8 9 years. What kind of professional certifications or additional training have you had since you left college? A. I received the HCAFA designation, which is the Health Care Anti-fraud Associates, which is by America's 10 Health Insurance Plans. 11 A-H-F-I, which is Accredited Healthcare Fraud Investigator, 12 and that is from the National Healthcare Antifraud 13 Association, as well as a Certified Professional Coder P. 14 "P" stands for payor, and that's from the American Academy of 15 Professional Coders. 16 17 THE COURT: This case has more abbreviations than anything. 18 19 I am considered an AHFI, which is MS. BEATTY: It's almost like an environmental law case, your Honor. 20 THE COURT: That's right. 21 22 BY MS. BEATTY: 23 Q. Are those all the certifications that you have? 24 A. Yes. 25 Q. Can you give me a brief description of your 304 1 employment background? 2 A. I started with Blue Cross/Blue Shield 15 years 3 ago. 4 service providing benefit information and claims information 5 to providers and members. 6 trained customer service representatives for a few years. 7 worked in our appeals department. 8 business analyst, meaning that I was a subject matter expert 9 on the claims processing system. 10 I started in customer service. I worked in customer I then moved into training and I I I was then a claims And then 5 1/2 years ago, I became a fraud investigator. 11 Q. And is that the position you hold now? 12 A. Yes. 13 Q. Are you familiar with Trina's billing practices? 14 A. Yes, I am. 15 Q. How did you become familiar with their practices? 16 A. I received several referrals. My department is 17 called the Special Investigations Department. 18 internal referral from our medical review department 19 indicating that Trina was billing for service that didn't 20 appear correct. 21 professional coders and she thought that Trina was doing 22 artificial pancreas treatment and billing it as covered 23 services, covered CPT codes. 24 25 I received an It came from one of our coders, our I received a second referral from the Blue Cross/Blue Shield Association through the Kansas plan. 305 1 It was a fraud alert stating that Trina was billing APT 2 services incorrectly and billing services as covered payable 3 infusion codes rather than G9147. 4 referral, a federal inquiry asking if we had any billing. 5 6 Q. Okay. And I received a third And when those referrals were made to you for investigations, what did you do? 7 A. I opened a preliminary investigation, which meant 8 that we start looking at billing, we requested records from 9 Trina and we start reviewing those. We received the records. 10 After we receive the records and compare those, we have our 11 medical director and coders review those as well to determine 12 if the billing is appropriate for the, to meet, to match the 13 medical records that were submitted. 14 15 Q. And following your gathering of information, what did your investigation conclude? 16 A. That Trina was billing APT services under covered 17 infusion services incorrectly and that they should have been 18 billed under G9147. 19 20 21 Q. What was Trina doing instead of billing under A. They -- I don't have the code in front of me but G9147? 22 they were billing office visits, prolonged physician 23 services, infusion services, pump refill, insulin, even the 24 cost of the insulin. 25 O2 monitoring, excuse me, glucose monitoring. There was some blood monitoring, some 306 1 Q. Ms. Smith, is it fair to characterize their 2 billing practices is they were billing component services 3 where they were unbundling a service and billing each item 4 individually rather than billing a general code that covers 5 all the service? 6 A. That is correct. 7 Q. Okay. And are the codes that Trina actually 8 billed, are those actual codes in the Blue Cross/Blue Shield 9 system that would be in process? 10 A. Yes. The codes that were billed were codes that 11 would not hit any flags in our system and they were just 12 processed through and paid. 13 14 Q. Okay. And so they were, for a period of time, they were processed and paid; were they not? 15 A. Yes. 16 Q. And had your investigators not been alerted to 17 this practice, would they still be being paid today under 18 those individuals codes? 19 A. Yes. 20 Q. Is it appropriate to bill for services in its 21 component parts if there is a general treatment code that 22 otherwise applies? 23 A. No. 24 Q. And why not? 25 A. It is appropriate -- Best practices state that you 307 1 bill the code that is most appropriate to the service 2 provided. 3 circumvent the system is what I do. 4 in Fraud, Waste and Abuse. 5 Q. And unbundling or billing the components to I look for those things Is it consistent with the industry standards 6 to bill components in pieces rather than the general 7 overall code? 8 A. No. 9 Q. And does Blue Cross/Blue Shield require its 10 participating providers to comply with industry standards 11 when coding and billing? 12 A. Yes. 13 Q. Do you know what it was about Trina's billing or 14 the codes it was using that ultimately hit your investigative 15 system or flagged it for you to further investigate? 16 A. There was one code that was billed more 17 frequently than typically it should have been and that's how 18 our medical review team caught it. 19 was being billed too many times and that's the flag that 20 finally came up. 21 Q. 22 23 The system saw that it After your investigation concluded that there was not proper billing on Trina's part, what did you guys do? A. We sent Trina a cease and desist letter letting 24 them know that they could not bill those component parts as 25 APT services. 308 1 Q. There was some -- Were you in the courtroom for 2 the testimony of the plaintiff's witnesses in the last couple 3 of days? 4 A. Yes, I was. 5 Q. Do you recall the testimony that Ron Briggs 6 first sought treatment in 2014 or 2015 for APT and received 7 APT services? 8 A. Yes. 9 Q. And do you recall the testimony that there was, 10 those claims were submitted and paid by Blue Cross/ 11 Blue Shield Montana? 12 A. Yes. 13 Q. Can you explain why those claims were paid? 14 A. Yes. Those claims were also billed incorrectly by 15 Trina. 16 hit a system and they would just process through the system 17 and a pay according to the member's benefits thus 18 circumventing the exclusion that Blue Cross/Blue Shield would 19 consider APT experimental investigational. 20 Those were also billed under CPT codes that would not Q. If Trina had been billing that way for this 21 extended period of time, why did it take your team, why did 22 it take so long for that practice to be flagged by your team 23 as needing further investigation? 24 25 A. Because those codes that were billed were all payable component codes and it was just eventually, the system 309 1 saw that one of the CPT codes that was billed was being billed 2 too frequently. 3 the claim came up, she saw, oh, it was the same code she saw 4 yesterday for the same patient and it shouldn't have been 5 billed that many times so that's when it became a red flag 6 to her. 7 Q. The nurse saw, a nurse that works the claim, Were you also present for Mrs. Briggs' testimony 8 on Wednesday that she believed if a patient has insurance 9 that the provider must bill the insurance carrier and cannot 10 bill a patient directly? 11 A. Yes. 12 Q. Do you agree with her assessment? 13 A. No, I do not. 14 Q. Why not? 15 A. Because members can have any service that they 16 want. 17 doesn't mean that it's a covered benefit under your medical 18 plan. 19 services or services that aren't considered covered under the 20 plan. 21 provider can still bill them. 22 member know ahead that that's not covered under their health 23 plan. 24 25 You can have any medical procedure that you want. It happens all the time. People choose elective They are financially responsible for them. Q. That The They just have to let the When you say "not covered under their health plan", what does that mean from a payment standpoint? 310 1 A. That means that there would be no payment because 2 the service is either not a benefit of the contract or it's 3 considered experimental or investigational. 4 5 Q. service, then how does the provider get reimbursed? 6 7 A. 10 The member would be financially responsible for those services. 8 9 If the insurance carrier is not paying for the Q. Ms. Smith, did you present affidavits in this A. Yes, I did. case? 11 MS. BEATTY: Okay. Your Honor, I believe that her 12 affidavits are part of the grouping that we have previously 13 admitted. 14 THE COURT: I think they are. And I don't recall 15 seeing her name specifically, but I just want to make a 16 record that, let me see if I can find the docket number 17 really quickly. 18 It may be attached to your order. Ms. MacLean, I am assuming that you do not have 19 any objection to admitting Ms. Smith's affidavit under the 20 same understanding as the admission of the other witnesses, 21 who are available? 22 MS. MacLEAN: Your Honor, I don't think that 23 the -- We believe that the affidavit is incorrect and for the 24 vast majority of it so I mean, yes, we do object to it 25 because it's not, the affidavit she made did not go for the 311 1 purposes of this hearing. 2 our motion for remand in federal court so the purpose of her, 3 her -- and if you can look at the -- 4 THE COURT: She made them for the purposes of I understand that you object. You 5 object to the content just in the same way Ms. Beatty 6 objected to some of the content of your affidavit. 7 going to admit it for the purposes of, same purposes I did 8 the affidavits of the plaintiffs. 9 evidence is the witness present and I understand that you are 10 I am And obviously, the best going to be cross-examining. 11 MS. BEATTY: Thank your, Honor. Just to be clear, 12 there were two affidavits that Ms. Smith presented. 13 early on in October, early November. 14 December, and they were both in response to Ms. Romine's 15 affidavits. 16 come into the record, then Ms. Smith's should come in as 17 well. 18 One was The second one was in And so I think if her affidavits are going to THE COURT: And I have already ordered that all 19 affidavits -- because I think all of the witnesses have been 20 available for testimony -- are going to be admitted and 21 considered. 22 Ms. Smith and I did find also Docket No. 40 for Ms. Romine 23 that I don't think I listed. 24 25 I just haven't found the exact docket number for MS. BEATTY: Okay. Anyway, that is in. Thank you, your Honor. 312 1 2 BY MS. BEATTY: Q. Ms. Smith, did you prepare each of those 3 affidavits to respond to the affidavit testimony of 4 Ms. Romine? 5 A. Yes, I did. 6 Q. And is the information in each of those two 7 affidavits still true and correct to the best of your 8 knowledge? 9 A. Yes, it is. 10 Q. And Ms. Smith, have you had a chance to review 11 12 13 14 15 16 17 18 19 Ms. Romine's third affidavit? A. I have had a chance to review it. I have not had a chance to prepare a response. Q. Okay. Did you review it with sufficient details such that you have an opinion about its contents? A. I reviewed it, I reviewed it. I have not reserved it but I do have an opinion. Q. Okay. So do you take issue with any of the contents of Ms. Romine's third affidavit? 20 A. Yes, I do. 21 Q. And generally, what is your concern with her 22 23 affidavit? A. My concern is the dollar figure that she reports. 24 I don't remember the exact dollar figure but it was 25 400-and-some-dollars that she thought would be paid by Blue 313 1 Cross/ Blue Shield. 2 submitted by Trina, they were much higher than $444. 3 Blue Cross paid multiple claims significantly more than that. 4 5 But looking back at the claims that were MS. BEATTY: THE COURT: 7 MS. BEATTY: THE COURT: 10 I think, your Honor, that that is all Thank you. Ms. MacLean, keeping in mind that it's a quarter to 5 -- 12 13 Okay. the questions I have of this witness at this time. 9 11 One moment, your Honor. I'm just making sure I am done with her. 6 8 Thank you. And MS. MacLEAN: I significantly trimmed in my questions, your Honor. 14 15 CROSS-EXAMINATION 16 17 BY MS. MacLEAN: 18 Q. Good afternoon, Ms. Smith. You stated that the 19 coder needs to use the code most appropriate to the treatment 20 provided, correct? 21 A. That's correct. 22 Q. And you don't have personal experience with the 23 treatment process for APT/ MII, do you? 24 A. No, I have not received the treatment. 25 Q. And when you referred to APT, you are actually 314 1 2 3 4 referring to CIIIT when you stated APT, correct? A. No. I am referring to artificial pancreas treatments provided by Trina. Q. Okay. So we needed to clarify that because you 5 were referring to the treatments that were contained in the 6 policy as APT and there is nothing in the medical policy 7 201.208 that says "APT", does it? 8 A. You are correct. 9 Q. Wouldn't you agree with me that the person who 10 understands the treatment process is the person who can most 11 accurately bill for that treatment process? 12 13 14 A. Would I agree with that? I think that there is financial gain to be had by billing incorrectly. Q. And there is also financial gain for you to go in 15 and take back money from providers who have already been paid 16 money to provide treatments, correct? 17 18 MS. BEATTY: Objection. Assumed facts not evidence. 19 THE COURT: Sustained. 20 21 BY MS. MacLEAN: 22 Q. So what you are saying today regarding your 23 testimony on Taylor Romine's affidavit is looking into the 24 past regarding what's been submitted in the past, and you are 25 not looking at what has been prepared to be submitted to 315 1 Blue Cross/Blue Shield in the future, correct? 2 MS. BEATTY: Objection. 3 understand the question actually. 4 THE COURT: 5 either. I don't know -- I don't I don't understand the question Sustained. 6 7 MS. MacLEAN: So let me try to -- I am trying to 8 put too many questions together, your Honor, in order to get 9 to this too fast so I am going to pull it apart. 10 11 BY MS. MacLEAN: 12 Q. Your testimony is that your affidavit was based 13 upon past claims received, correct. 14 MS. BEATTY: 15 itself. Objection. The record will speak for It mischaracterizes her testimony. 16 THE COURT: Overruled. 17 THE WITNESS: That is correct. 18 19 BY MS. MacLEAN: 20 Q. 21 And you reviewed Taylor Romine's affidavit, correct? 22 A. Yes. 23 Q. And her affidavit is based upon a treatment 24 25 scheduled detailed by Dr. Elliott, isn't it? A. The treatment -- 316 1 Q. Yes or no. 2 A. Yes. 3 4 MS. BEATTY: I think she should be entitled to the answer the question. 5 6 Objection. THE COURT: Sustained; sustained. Please allow her to answer the question. 7 THE WITNESS: The treatment that Dr. Elliott 8 planned does not include multiple codes that were billed over 9 the course from October of '15 through April of '17 that were 10 consistently billed throughout the treatment plan. So the 11 question is were those services not necessary or are the 12 services, are they only going to bill the services -- For 13 example, are they going to bill office visits, are they going 14 to bill prolonged physicians services, which were not 15 included? 16 17 BY MS. MacLEAN: 18 Q. 19 20 Taylor Romine, isn't it? A. 21 22 I think that's the question that we need to ask Yes. MS. MacLEAN: Thank you. No further questions, your Honor. 23 THE COURT: 24 MS. BEATTY: 25 THE COURT: Thank you. No redirect. All right. May this witness be 317 1 excused? 2 MS. BEATTY: 3 THE COURT: 4 Yes, she may. Thank you for your testimony. excused. 5 (Witness excused.) 6 THE COURT: 7 MS. BEATTY: 8 THE COURT: 9 10 You are 10 minutes. Do you have any other witnesses? We do not. All right. So thank you for giving me I wanted to discuss with all of you briefly with Joslyn with us. 11 MS. MacLEAN: Your Honor, we have witnesses 12 waiting to potentially be rebuttal witnesses. 13 going to allow rebuttal witnesses. 14 THE COURT: Are you not Well, I want you to think about that. 15 I can't go past 5. 16 really need a rebuttal witness? 17 both of your points. I think that the issues have been 18 thoroughly examined. If you believe there is actually new 19 testimony, I will certainly allow you to give that testimony 20 until 5 but I have to cut this off at some point and I want 21 to discuss with the lawyers kind of where we go from here, 22 as well. 23 I need to talk about bookkeeping. MS. MacLEAN: Do you I mean I think I understand I guess where I am coming from, 24 your Honor, is the two individuals that we have to rebut the 25 testimony had not previously been able to understand what 318 1 Blue Cross/Blue Shield was going to provide in testimony. 2 the other hand, we provided the vast majority of our 3 testimony ahead of time. 4 THE COURT: Let me just address it this way. On I 5 think we have two issues here. We have a declaratory 6 judgment matter and more importantly or more imperatively, at 7 this point we have a preliminary injunction that has to be 8 decided by me and I am expected to decide that promptly. 9 I think that the way that I would solve the rebuttal issue if So 10 you really believe that there is rebuttal information that's 11 necessary for the preliminary injunction is I would like you 12 to take that testimony in a deposition. 13 this format and submit it to me in transcript form and in a 14 video so that I can see it, keeping in mind time 15 considerations and provide that and I will not make any 16 decisions until I have seen that rebuttal testimony to be 17 completely fair to all of the plaintiffs, Trina and the 18 individual plaintiffs. 19 on the fast track and I am going to ask you to do that 20 outside of the courtroom. 21 suggest that you handle that. 22 about the procedure that I am going to be using on the 23 declaratory judgment action but I do want to ask you a few 24 questions about housekeeping and hope that your answers are 25 relatively brief. You can do it in But we are going to need to do that So that is how I am going to And that's a predictor for you 319 1 Ms. MacLean, you are, I think, ultimately going to 2 be asking the Court to order coverage of APT for these, at 3 least these plaintiffs. Is my understanding correct? 4 MS. MacLEAN: 5 THE COURT: Yes, your Honor. Okay. And here is what I am going to 6 be asking people to include in their briefing on the 7 declaratory judgment action. 8 about this later, but I think that I need to hear from you as 9 to whether and why not a contract issue should not be a And I will be more thorough 10 question of whether the language of the contract as it is 11 written covers the procedure in question. 12 why is this not just a contract coverage issue or is it? 13 Maybe that's what you are saying it is. 14 saying? 15 MS. MacLEAN: 16 THE COURT: In other words, Is that what you are Yes, your Honor. So you are not asking me -- because 17 that was going to be my next question for briefing is what 18 authority is there for me to alter the contract? 19 20 MS. MacLEAN: It's on the face of the contract (indiscernible). 21 22 There is none, your Honor. THE COURT REPORTER: what? On the face of the contract I'm sorry. 23 MS. MacLEAN: On the face of the petition. 24 THE COURT: 25 And then I just want to make sure I am clear. Okay. Thank you. 320 1 Isn't it 30 percent of the Trina patients, 3 out of 10, as I 2 understood Ms. Romine, were Blue Cross/Blue Shield's insureds 3 at the time in April? 4 5 MS. MacLEAN: in some way Blue Cross/Blue Shield of Montana insureds. 6 7 THE COURT: 10 I heard 40 percent but then I heard Ms. Romine say 3 out of 10 so I didn't understand. 8 9 The record will say 40 percent were MS. MacLEAN: It's the difference between primary policies and secondary policies, your Honor, and whether or not those policies could be billed. 11 THE COURT: 12 addressed in briefing. 13 All right. That may have to be This is another thing for briefing but I want to 14 know what the legal basis is, if you are asking, Ms. MacLean, 15 for the Court to alter the Blue Cross/Blue Shield 16 interpretation of its medical policy. 17 part of what you are asking for? 18 MS. MacLEAN: Is that going to be Your Honor, what we are asking for 19 is for the Court to look at the policy and plans on their 20 face and to determine whether or not APT/MII was 21 appropriately addressed on its face in relation to those 22 policies. 23 square peg was trying to be fit into a round hole in order to 24 make this determination essentially. 25 Hopefully, the testimony showed that something, a THE COURT: Okay. All right. Thank you. I 321 1 understand that. 2 All right. So what I would like to do is I am 3 going to set a short track for this. 4 everyone's schedule is but I am thinking in terms of 7 days 5 to get whatever deposition testimony you need to get 6 accomplished. 7 a transcript turned around. 8 to speedily respond to this as you are wanting me to do, Ms. 9 MacLean. 10 11 I don't know what That may be pushing the court reporter to get I welcome input but I am trying So what do you think is reasonable, and what I am talking about right now is just rebuttal testimony. MS. MacLEAN: Your Honor, I do need to confer with 12 the individuals who were here testifying, see what it is they 13 believe needs to be corrected. 14 THE COURT: All right. And so I guess I am 15 thinking more logistically in terms of court reporters, 16 getting your body in front of a TV or whatever and getting 17 the defendant's counsel's body in front of a TV so you can 18 accomplish that testimony. 19 MS. MacLEAN: Your Honor, what we are most 20 concerned about is the patients starting treatment this week. 21 They had their two treatments this week. 22 treatment was this morning. 23 THE COURT: 24 MS. MacLEAN: 25 The second I understand. That treatment process has to start with two treatments and then go to one each week. What I am 322 1 most concerned about is they are able to continue to get 2 their treatment while we get whatever it is we need to get on 3 the record and while you consider what is on the record 4 already. 5 THE COURT: Well, let me hear from the defendants 6 because my concern is my job is to respond to this speedily. 7 I am trying my best to respond speedily within the available 8 time that we all have. 9 Mr. Auerbach? 10 MS. BEATTY: So is this Ms. Beatty or So your Honor, that's kind of why we 11 filed our motion requesting a delay of the preliminary 12 injunction and why we agreed that the temporary restraining 13 order could remain in place until we had a proper process for 14 the PI hearing. 15 or extending the TRO beyond the date that it would naturally 16 expire provided we move forward fairly quickly with the rest 17 of this. 18 going to have rebuttal witnesses by deposition and the Court 19 won't be there to address objections that might be raised. 20 understand your concerns and I am okay with it. 21 you to know we're worried about that. I guess I don't have any problem with that I am concerned about this process where we are 22 THE COURT: I I just want If you -- Both parties are concerned 23 about that. I am, I am only try trying to respond to 24 statutory requirements so if you would like me to set another 25 hearing, it won't be next week. It will probably -- I have 323 1 so many trials coming up through March that it's just insane 2 so it may not be for 45, 60 days and so if the parties can 3 live with that, I would propose we get on a conference call, 4 perhaps even next week and try to come up with a schedule and 5 perhaps by the time we have that conference call, you folks 6 could confer and just -- you don't have to agree on anything 7 other than calendars. 8 MS. BEATTY: Right. I guess I am -- I want to be 9 cognizant of your trial schedule too and I don't want this to 10 go on indefinitely and so maybe I will confer with co-counsel 11 and we will, just maybe we can both confer about how we do 12 this process and if we can reach an agreement that a 13 deposition is appropriate then maybe that's the best way 14 to go. 15 THE COURT: I mean I can probably do it sooner 16 depending on how much time we need but finding days are 17 difficult. 18 MS. BEATTY: 19 THE COURT: I understand. And Fridays and Wednesdays sometimes 20 will work for me. Those are usually the best days. I want 21 everyone to get due process. 22 the issues as I am required to do by statute so I am willing 23 to work with you. 24 fulfill my obligations here to everyone concerned so I just 25 want to make sure I know what our plan is. I also want to speedily resolve I just am trying to get, I am trying to 324 1 2 MS. BEATTY: Perhaps Ms. MacLean and I can confer and provide you with a status report on Monday. 3 THE COURT: Okay. If you want to do it live, I 4 am simply trying to make it possible. 5 live, we can probably do it in the next 30 days at some 6 point. 7 MS. BEATTY: 8 THE COURT: 9 MS. MacLEAN: If you want to do it Thank you. You are welcome. Thank you all. So your Honor, to clarify, the 10 temporary restraining order will remain in place and Trina of 11 Montana can submit its bills to Blue Cross/Blue Shield of 12 Montana. 13 THE COURT: 14 MS. MacLEAN: 15 THE COURT: 16 I think we have got -- 17 MS. BEATTY: Until further notice. Until further notice. Or order of the Court. One minute. Yeah, I guess I just want to make 18 that that temporary restraining order applies only to the two 19 plaintiff patients. 20 THE COURT: 21 MS. BEATTY: 22 23 Yes. It doesn't apply to the some broader yet-to-be-signed-up patients. THE COURT: I am not going to expand this beyond 24 the two named individual plaintiffs so there should be no 25 misunderstanding on the part of Trina that this is carte 325 1 blanch to go out and collect people to come in. 2 keep this a narrow issue for me to resolve and we will move 3 from there. 4 I want to All right. MS. BEATTY: And your Honor, what are you thinking 5 about for a briefing schedule once we do either submit you 6 with a deposition testimony or we have the rebuttal live? 7 THE COURT: Well, I am willing to, I am willing to 8 work with you. It's a question of -- I mean if you agree, I 9 will work with whatever schedule you want. If you don't 10 agree, then I will probably impose, I don't know, probably a 11 21-day simultaneous briefing schedule following the close of 12 putting in the evidence. 13 promise you is I will work as fast as I can to come up with 14 an order. 15 16 MS. MacLEAN: And I will, the only thing I can So that wouldn't be an opposition brief filed and then a reply brief, in that order. 17 THE COURT: No. I would like -- I mean everyone 18 has filed briefs. 19 have simultaneous post-hearing briefs. 20 I mean you have done that. MS. MacLEAN: I just want to So, your Honor, are you recognizing 21 the opposition brief that was filed to the other temporary 22 restraining order? 23 right now. 24 25 Is that what you are trying to recognize THE COURT: I have read every brief in the file and there have been several of them that looked fairly 326 1 similar to each other. 2 number you are referring to. 3 I am not, I am not sure which docket MS. MacLEAN: And so the reason I am trying to 4 clarify is what happened was Trina and the plaintiff patients 5 filed a TRO and then that was denied and then Blue Cross/ 6 Blue Shield filed their opposition and we filed a reply 7 saying we don't think they were supposed to do that because 8 it had been denied. 9 We then refiled the -- THE COURT: 10 I understand. MS. MacLEAN: And so right now, we are standing 11 with our motion for a temporary restraining order sitting 12 without any opposition to it. 13 THE COURT: Well, I think where we are is that we 14 have got plenty of opposition on both sides and I understand 15 what it is. 16 hearing briefs simultaneously 21 days after, after we have 17 agreed that all the evidence is in. 18 will hear from all of you sometime early next week. So what I would like to do is just get post- 19 MS. BEATTY: 20 THE COURT: 21 them to the clerk. All right. And so I Okay. Thank you, your Honor. I have these two exhibits. I will get Thank you all. 22 MS. MacLEAN: 23 MR. AUERBACH: Thank you, your Honor. Thank you, your Honor. 24 25 (Proceedings were adjourned at 4:58 p.m.) 327 1 CERTIFICATE OF REPORTER 2 3 I, JOSLYN CUMMINGS, Official Court Reporter, 4 Do hereby certify that I reported in machine shorthand 5 the foregoing proceedings at the times, places and with the 6 appearances of counsel hereinbefore noted. 7 I further certify that the transcript transcribed from my 8 original shorthand notes by means of computer-assisted 9 transcription, is a full, true, and correct transcript of the 10 11 oral testimony adduced therein, to the best of my ability. I further certify that I am not of counsel for, nor in 12 any way related to, any of the parties in this matter, nor am I 13 in any way interested in the outcome thereof. 14 15 IN WITNESS WHEREOF, I have hereunto set my hand this 15th day of February, 2018. 16 17 18 19 20 21 22 23 24 25 /s/ Joslyn Cummings JOSLYN CUMMINGS Official Court Reporter