JUDICIAL DISTRICT coumr BEAVERHEAD couurv MAR 0 5, 2018 . 5.. MONTANA FIFTH JUDICIAL DISTRICT COURT, BEAVERHEAD COUNTY TRINA HEALTH OF MONTANA LLC. HAROLD LARON BRIGGS, BARRY BRIGGS, and HAROLD L. GROGAN, Plaintiffs, Cause No. VS. HEALTH CARE SERVICE ORDER DENYING CORPORATION d/b/a BLUE CROSS PRELIMINARY INJUNCTION AND BLUE SHIELD OF MONTANA, Defendant. Plaintiffs, Trina Health of Montana, LLC, Harold Laron (Ron) Briggs, Barry Briggs, and Harold L. Grogan (?Trina?) petitioned for declaratory judgment and applied for a preliminary injunction and permanent injunctive relief to prevent Defendant Healthcare Service Corporation, d/b/a Blue Cross Blue Shield from denying coverage for Arti?cial Pancreas Treatment (APT). BACKGROUND The individual Plaintiffs, Ron Briggs, Barry Briggs, and Harold Grogan, received the APT treatments at the Trina facility owned by Ron and his Wife, Trina Health of Montana v. Healthcare Service Corp. Order Denying Preliminary Injunction - 1 Julie, in Dillon. Ron and Julie initially traveled frequently to Scottsdale, Arizona, to receive the treatments, which provide microburst insulin in?tsion (MII), at the Trina clinic in Scottsdale. To save money, in 2015 they negotiated with Trina Corporation in Sacramento, California, and became the exclusive Montana licensee to deliver at a clinic in Dillon. Thereafter, the Montana Trina facility began treating 10-15 patients, including Ron. The Dillon Trina facility treated patients between Fall of 2015 and April, 2017. Ron, Barry Briggs, and Harold Grogan were insured for healthcare by BCBS. Their policies, in relevant part, are the same. The BCBS policies exclude coverage for experimental and investigational treatments. Trina billed BCBS for the treatments by coding under multiple codes, breaking the treatments into coding parts for of?ce visits and medical supplies rather than identifying the speci?c procedure. BCBS paid the claims submitted for treatments of the individual Plaintiffs ?'om September 28, 2015, to April 12, 2017. In 2017, BCBS conducted a routine audit and discovered that the procedure was being billed this way. On April 12, 2017, BCBS issuedta ?cease and desist? letter directing Trina to code the procedure under code 69147, which is the code for ?outpatient intravenous insulin treatment (OIVIT). BCBS does not cover OIVIT because it considers it experimental and investigative. Trina Health of Montana v. Healthcare Service Corp. Order Denying Preliminary Injunction 2 BCBS bases its coverage on its own Health Care Services Corporation Medical Policy MED201.028, ?Chronic Intermittent Intravenous Insulin Therapy,? (also known as dated May 15, 2016. This policy was not adopted by BCBS until June 1, 2017, almost two months after its ?cease and desist letter? was sent to Trina. PROCEDURAL HISTORY Trina ?led its original petition on October 23, 2017. On October 24, 2017, Hon. Luke Berger granted a Temporary Restraining Order (TRO). On October 30, 2017, BCBS ?led a notice of removing the case to federal court. On November 6, 2017, Hon. Sam Haddon held a hearing in federal court on the re- ?led TRO petition. On December 19, 2017, Judge Haddonheard argument on federal jurisdiction and remanded the case to this Court. On December 20, 2017, Trina again ?led an emergency TRO petition and requested a show cause hearing. On December 21, 2017, BCBS moved to substitute Judge Berger. On January 18, 2017, following brie?ng on the timeliness of the substitution motion, the undersigned accepted the case. On January 23, 2018, Plaintiffs again asked for a TRO, which the Court granted on January 26, 2018, and set a show cause hearing for January 31, 2018. HEARING Trina Health of Montana v. Healthcare Service Corp. Order Denying Preliminary Injunction - 3 The Court heard evidence on Trina?s request for a preliminary injunction on January 31 and February 2, 2018. On January 31, 2018, Julie Briggs (Julie), Ron?s widow, appearing from Dillon with her lawyers via VisionNet, with the Court sitting in Cascade County because of prior scheduled matters earlier in the day, testi?ed at the preliminary injunction hearing. Although she said she was the ?administrator? of the Trina facility in Dillon, she seemed unfamiliar with its practices, billing decisions, or coding. Julie testi?ed that BCBS forced Trina in Dillon to shut its doors and close down through its ?cease and desist letter.? Julie testi?ed that, including her husband Ron, three of the 10-15 Dillon Trina patients were insured by BCBS. Those three patients are the named Plaintiffs. The other patients were insured by Medicare or other insurers. Julie admitted that Medicare was conducting an audit during the same period when the BCBS letter was issued, and that Medicare refused to pay for the procedures during the audit. She did not answer in a comprehensible way whether other insurers also refused to cover the treatments. She testi?ed in varying ways, sometimes contradictory, but seemed to insist it was letter that drove Trina out of business. The Court did not ?nd Julie?s testimony to be credible on the above points. Julie testi?ed that Trina has posted an injunction bond in the amount of $53,327.50 [Hearing Ex. 1) so that BCBS is not harmed by paying costs of Trina Health of Montana v. Healthcare Service Corp. Order Denying Preliminary Injunction 4 for the Plaintiffs until the Court decides the substantive issues in the event a preliminary injunction is granted. Barry Briggs1 and Harold Grogan also testi?ed via Vision Net. Both men are very sick with diabetes. They were treated at Trina for about a year and a half, after Julie and Ron Opened the Dillon clinic. Both received twice weekly (or more) treatments at the clinic until the BCBS letter was received. Both testi?ed that they were covered for these treatments under their BCBS policies until then. Both men sincerely testi?ed that they believed that the treatments made them feel better, and that since the treatments stopped, they felt worse. Both testi?ed that they believed that their usual doctors did not ?understand? diabetes, but that Trina did. Dr. John Elliott, an obstetrician and the Trina corporate Medical Director, testi?ed via the ?Remote Presence? app from Dallas, TX. He testi?ed that APTMI is different than the excluded treatments under the BCBS policies. He also pointed to an article that he wrote, in his capacity as the Trina Medical Director, about an ?observational study? of patientsusing the Trina treatment, showing improved He describes the study as a peer reviewed paper showing that the Trina treatments are not experimental or investigative, and that they should therefore be covered. Dr. Elliott testi?ed that Barry Briggs testi?ed that he is not related to Julie or Ron. Trina Health of Montana v. Healthcare Service Corp. Order Denying Preliminary Injunction - 5 the Trina treatments are different than the excluded OIVIT treatments because they are delivered through a different pump and ?burst? insulin at different intervals. On February 2, 2018, the hearing continued. Medical Director, Dr. Jean-Pierre Pujol, testi?ed that BCBS Medical Policy MEDZOLOZS is authored by the BCBS Medical Policy Committee following review of scienti?c information, literature, expert information and claims data. The Committee reviews literature and guidelines published by relevant Specialty societies and associations in order to establish policies. In this case, it reviewed published scienti?c literature of the American Diabetes Association. The Committee speci?cally seeks out evidence-based and peer-reviewed studies, as- well as industry standards of care, and reviews policies at least annually. As with any scienti?c evaluation, the Committee weighs less heavily anecdotal and observational studies, and considers them less reliable than randomized control and meta-analytical studies. The Committee also considers standards in the ?industry,? which in, this case means other providers of health bene?t plans. Dr. Pujol testi?ed that in the case of Trina?s APT, because the only study attesting to its effectiveness is an observational study, the results of which are authored by Dr. Elliott, a part owner of Trina, and there are no randomized control, meta-analysis type studies, the APT treatment is considered Trina Health of Montana v. Healthcare Service Corp. Order Denying Preliminary Injunction - 6 . experimental, investigational, and unproven. Moreover, other health care plan carriers likewise exclude coverage of OIVIT, and APT because they are still considered investigational. Dr. Pujol testi?ed that APT does not meet Medical Policy standards for scienti?c basis or industry standard acceptance. Accordingly, it is excluded. Dr. Pujol ?irther testi?ed that APT most closely meets the coding - de?nition of 69147, intravenous insulin therapy, which code is expressly excluded under MED201.028. In rebuttal deposition testimony, Dr. Elliott testi?ed that Dr. Pujol does not understand APT, and that APT is clearly distinguishable from PIVIT, OIVIT, and However, Dr. Elliottexpressly admitted in his rebuttal that APT ?is a We of PI VI (Rebuttal depo., p. 87). According to Dr. Elliott, APT is the current state of ?evolution? of Id. Marketing on the Trina website claims that and PIVIT are evidence that APT is effective. Despite these admissions, Plaintiffs assert that APT ?is not OIVIT or by de?nition.? Piaz'ntr'ffs Post- Hearz'ng Brief p. 14. For a year and a half, Trina submitted bills to BCBS coded in a way that APT was not identi?ed as the actual service, and instead multiple individual fragments of the treatment were coded separately. When a BCBS coder, Jamie Smith, noted the odd billing pattern, known as ?unbundling,? and an audit was Trina Health of Montana v. Healthcare Service Corp. Order Denying Preliminary Injunction - 7 conducted, BCBS directed the correct coding for the billing. In her rebuttal testimony, Trina billing witness Taylor Romine admitted that it is not permissible to ?just take a code, rip it apart, and put any codes you (Post-hearing depo., 37). Testimony at the hearing disclosed that federal regulators are now investigating Trina?s billing practices, and that Kansas BCBS has issued a fraud alert related to the same practices. ANALYSIS Section 27?19?201, MCA governs preliminary injunctions in Montana. It provides several disjunctive circumstances under which an injunction may be ordered: 1) 2) 3) 4) 5) When it appears the applicant is entitled to relief; When it appears the applicant would suffer great or irreparable injury if the relief is not granted; When the adverse party is doing or threatening to do something to the applicant if the relief is not granted; When the adverse party is threatening to remove or dispose of the adverse party?s property with intent to defraud the applicant; When it appears that the applicant has applied for an order under ?40-4-121, MCA or an order of protection under Title 40, Chapter 15. Trina Health of Montana v. Healthcare Service Corp- Order Denying Preliminary Injunction - 3 Trina is only required to prove one of the above criteria to be entitled to preliminary injunctive relief. Sweet Grass Farms, Ltd. 12. Bd. of Co. Comm ?rs of Sweet Grass C0., 2000, MT 147, 1i27, 300 Mont.66, 2 P.3d 825. Trina asserts that paragraphs 1) and (2) apply here. To show the likelihood of success on the merits and irreparable harm, the Court looks to recent Montana cases for guidance. See, for example, Doe v. Community Med. Ctr., 2009 MT 395, 1118, 353 Mont. 378, 221 P.3d 651, Cole v. St. James Healthcare, 2008 MT 453, 1115, 348 Mont.68, 199 P.3d 810. A preliminary injunction may be granted where the Plaintiffs show that they have ?a legitimate cause of action? and are ?likely to succeed on the merits.? Cole, 1[15. To show a ?likelihood. of irreparable harm? the Plaintiffs generally - must show that money damages are inadequate. Caldwell v. Saba, 2013 MT 240, 1129, 371 Mont. 328, 308 P.3d 81. A. Likelihood of Success on the Merits. The Plaintiffs assert that BCBS improperly applied its own exclusionary language to the bene?t plans at issue. The plain language of the individual Plaintiffs? health bene?t plans gives BCBS discretion to interpret and apply its ?Medical Policies? in order to make coverage determinations. Ex. 3, p. 282. BCBS de?nes its ?Medical Policy? to determine coverage as relying on criteria including ?nal approval from governmental regulatory agencies, scienti?c Trina Health of Montana v. Healthcare Service Corp. Order Denying Preliminary Injunction - 9 studies showing conclusive evidence of improved net health outcome, and established standards of good medical practice. Ex. 3, p. 321. The plans at issue in this case explicitly exclude from coverage ?Any services, supplies, drugs and devices which are: Ex. 2., pp. 182, 183. BCBS Medical Policy provides that ?Chronic intermittent intravenous insulin therapy is considered experimental, investigational, and/or unproven.? Ex. 5, p. 392. By the express language of the policy, under own interpretation of its policy, then, is excluded from coverage. The question then presented is whether the APT treatments offered by Plaintiff Trina are GMT, and excluded frorncoverage. .. . To show that they are likely to succeed on the merits, Plaintiffs must Show that BCBS likely violated a contractual or other duty. Doe v. Community Medical Center, Inc., 2009 MT 395, 1H9, 353 Mont. 378, 221 P.3d 361. The Preferred Provider Agreement (PPA) expressly excludes APT and its related treatments, and defers to its medical policies such as MED201.028. Trina is . bound by the PPA to follow BCBS policies. Ex. C, Art. II, ?lO. In the PPA, Trina agrees that BCBS is not required to pay for services it does not cover. Id., Art. IV, The agreement between the two corporations also requires resolution of disputes through, inter alia, arbitration. Trina Health of Montana v. Healthcare Service Corp. Order Denying Preliminary Injunction - 10 The testimony before the Court is that one of the Plaintiffs has died, and the remaining individual Plaintiffs are very sick with diabetes. No treating physicians have testi?ed about the actual state of the Plaintiffs? health, the cause of Ron Briggs?s death, the ef?cacy of the treatment at issue, or the relationship between the living Plaintiffs? current health and the fact that they have not been treated by since April, 2017. While the Plaintiffs, including the widow of Ron Briggs, have testi?ed that they believe that without the availability of care from the Dillon Trina Clinic, they will suffer irreparable harm, a showing to meet necessary legal standards has not been met. Several witnesses have testified to the availability of treatment in Scottsdale and other locations in the country. Moreover, the Plaintiffs? testimony re?ects that they are not being followed by endocrinologists, who are the specialists in diabetes. There is coverage for this type of care under the BCBS plan. It appears other alternatives are available, and some are not costly. The Court aclmowledges that Trina?s corporate Medical Director has offered very general, broad brush Opinions that the Plaintiffs would suffer irreparable harm. The Court is not satis?ed that Dr. Elliott?s testimony on this point is based on adequate foundation or satis?es any standard of proof. Dr. Elliott is an obstetrician, not an endocrinologist. He did not testify that he has Trina Health of Montana v. Healthcare Service Corp. Order Denying Preliminary Injunction - ll any relevant expertise in diabetes, other than his experience with prenatal diabetic patients and a father who had diabetes. The Court does not suggest that Dr. Elliott is not learned or thoughtful. However, to meet the relevant legal standards, he must have the expertise in the appropriate specialized scienti?c discipline. As to one of the primary issues, whether BCBS caused Trina in Dillon to close its doors, the Plaintiffs have not met their burden of proving a likelihood of success. Julie Briggs, who, for an administrator of a health care facility, has an astonishing dearth of knowledge about how her facility runs, the sources of revenue, and the coding required to bring in revenue, testi?ed that 10-15 patients, . total, were treated by Trina in Dillon when its doors were open. Two to three of those patients were insured by BCBS. Even assuming an improper application of policy exclusions, it is dif?cult to conceive that loss of income from those few BCBS covered patients is the cause of Trina?s decision to shut down. Ms. Briggs testi?ed that Medicare insured perhaps more patients, and stOpped coverage pending an audit. Other patients had private coverage according to Ms. Briggs, but inexplicably she did not remember whether those carriers covered the procedure. Moreover, assuming for the sake of argument that the loss of only the BCBS coverage shut down the Clinic, the Court is not persuaded that BCBS was Trina Health of Montana v. Healthcare Service Corp. Order Denying Preliminary Injunction 12 required to cover the procedure. The express terms of the policies exclude ?outpatient intravenous insulin treatmen which is known by the abbreviation, The plain language of this exclusion encompasses the treatment. It is outpatient. It is intravenous. It is insulin treatment. Whether experimental or not, APTIMII is excluded by the contract language. Accordingly, the Plaintiffs cannot meet the ?likelihood of success on the merits? prong necessary to obtain a preliminary or permanent injunction. Notwithstanding the above, the Court is not convinced that treatment is accepted within the medical community as a standard of care for diabetes. It is certainly showing hope?il signs. However, Dr. Elliott?s article, while well written, is not a peer reviewed article, and it suffers from the defect that it is simply not objective, in that it was written- and published by the company hoping to pro?t by its use. As such, it is viewed by the Court as more advanced marketing literature than a scienti?cally sound study. B. Irreparable Harm. To prevail on a preliminary injunction, the Plaintiffs ?must establish a prima facie case, or show that it is at least doubtful whether or not [they] will su?'er irreparable injury before [their] rights can be ?illy litigated.? Bene?s Healthcare v. Great Falls Clinic, LLP, 2006 MT 254, 1114, 334 Mont. 86, 146 P.3d 714. The individual Plaintiffs assert that they will suffer irreparable harm if Trina Health of Montana v. Healthcare Service Corp. Order Denying Preliminary Injunction - 13 the Court does not grant the preliminary injunction. They base this assertion on Plaintiff Trina?s claim that it cannot remain open if the injunction is not granted and it is allowed to continue billing ?unbundled? for the APT treatments. Undisputed testimony at the hearing is that, while more costly for the Plaintiffs if Trina's Dillon facility closes and they will have to travel, or because they may need to pay for the APT out-of-pooket if the Dillon facility does not close, they still can get APT treatment. So, assuming for argument?s sake that the APT treatment is effective, the individual Plaintiffs can avoid harm by paying out-of-pocket or by traveling to obtain services. Because this element of damages, if proven, can be compensated with money damages, Plaintiffs have not shown irreparable harm. Money damages are not irreparable harm. Caldwell v. Saba, 2013 MT 240, 1129, 371 Mont. 328, 308 P.3d 81. Plaintiff Trina argues that it will suffer irreparable harm without an injunction because if BCBS does not pay for APT it will have to ?close its doors.? The Court is not persuaded. At most, Trina had a total of 10 - 15 APT patients. Testimony at the hearing was that either 3 or 4 of those patients were insured by BCBS. Accordingly, it still has 7 - 11 patients who are paying for APT in other ways, either individually or through other carriers. The Court is not persuaded that enforcement of its exclusion forced Trina to close its doors. Assuming, arguendo, that BCBS forced Trina to close its doors, this harm Trina Health of Montana v. Healthcare Service Corp. Order Denying Preliminary Injunction - 14 can be remedied with money damages, and the ?irreparable harm? element has not been met. The cease?and-desist letters sent by BCBS to Trina did not require or force the door?closing. Not only did BCBS learn of the unbundling coding practice and direct it to stop, testimony at the hearing was that the U.S. Department of Health and Human Services, Center for Medicare and Medicaid Services (CMS), was investigating its practices and that the CMS investigation caused a halt in billing to CMS for APT for at least 180 days. BCBS showed that its audit and cease-and-desist letters were consistent with its own policies, the medical standard of care, and industry health insurance practices. Regardless of the reason that Trina Montana closed its doors, the evidence at the hearing was that the individual Plaintiffs can obtain APT treatment at other Trina clinics, and have done so. The treatment is not, however, covered under plans. C. Propriety of Iniunctive Relief The purpose of a preliminary injunction is to prevent ?irther injury or irreparable harm pending an adjudication on the merits. Flora v. Clearman, 2016 MT 290, 1111 13-23, 385 Mont. 341, 13-23, 384 P.3d 448, 1111 13-23; Yockey v. Kearns' Props, L.L.C., 2005 MT 27, 1] 18, 326 Mont. 28, 106 P.3d 1185. This Court is required to decide whether a suf?cient case was made to warrant the Trina Health of Montana v. Healthcare Service Corp. Order Denying Preliminary Injunction - preservation of the status quo until trial. Yockey, 1] 18. "Upon the requisite showing, a preliminary injunction is issued to maintain the status quo pending trial, which has been defined as ?the last actual, peaceable, noncontested condition which preceded the pending controversy!" Sandrock v. DeTz'enne, 2010 MT 237, 11 16, 358 Mont. 175, 243 P.3d 1123. (citations omitted). In Van Loan v. Van Loan, the Montana Supreme Court adopted the following test for determining whether an injunction is proper in a money damages context. The moving party has the burden of proving all elements: (1) the likelihood that the movant will succeed on the merits of the action; (2) the likelihood that the movant will suffer irreparable injury absent the issuance of a preliminary injunction; (3) the threatened injury to the movant outweighs whatever damage the proposed injunction may cause the opposing party (a balancing of the equities); and (4) the injunction, if issued, would not be adverse to the public interest. Van Loan v. Van Loan, 271 Mont. 176, 895 P.2d 614, 617-18 (1995). As discussed above, the question here is a monetary dispute. Plaintiffs ask the Court to declare that BCBS is required to cover APT and pay for it. BCBS disputes that it should be required to pay. The Court has discussed the evidence Trina Health of Montana v. Healthcare Service Corp. Order Denying Preliminary Injunction - I 6 adduced at the hearings and the post-hearing rebuttal depositions above. As to element (1), the Court concludes that the Plaintiffs are not likely to succeed on the merits. As discussed above, with respect to element (2), it is unlikely that Plaintiffs will suffer irreparable injury without an injunction. With respect to element (3), the threatened injuries to the Plaintiffs equal the damage an injunction may cause to BCBS. In other words, the cost of the APS treatment is the same. If the Plaintiffs pay it, they bear the burden. If BCBS pays, it bears the same burden. The Court acknowledges that the individual Plaintiffs will have to pay the costs of travel to obtain APS treatment elsewhere, however, and this tips the scale in their favor. As to element (4), the Plaintiffs have not shown that an injunction would not be adverse to the public interest. The Court recognizes that individual citizens are over a barrel in the health care climate currently. The Court further recognizes that the individual Plaintiffs are extremely sick, and need some form of effective treatment for relief ?'om their However, it has not been shown that requiring BCBS to cover a treatment which is clearly excluded is in the interests of the public. Section 27-19-201, MCA, provides, in part, that, ?[fjinal injunctive relief may only be granted if pecuniary compensation would not afford adequate Here, while ooncededly expensive, the Plaintiffs can (and some have) Trina Health of Montana v. Healthcare Service Corp. Order Denying Preliminary Injunction - 17 obtain APT in other Trina locations, even if Trina Montana remains closed. The only question presented is who will pay for the treatment. Pecuniary compensation would afford adequate relief. A preliminary injunction is not the appropriate remedy. Plaintiffs have an adequate remedy at law, if the facts and law support their claim. D. Propriegg of Declaratogy Judgment. The Court has not yet required either party to brief this issue. Although BCBS did brief it, to give the Plaintiffs a full opportunity, the Court below sets a brie?ng schedule. Both parties should brief the following: 1) Whether a breach of contract issue is proper to decide rights, status, and duties under a contract; 2) Whether, in light of the disputed fact issues in this case, declaratory judgment is proper. E. Arbitration. The Court has not yet called for brie?ng on pending Motion to Compel Arbitration and to Stay Remaining Claims. (Doc. 33). This Motion, as the Court understands it, focuses on Plaintiff Trina?s claims, and not those of the individual Plaintiffs. Below, the Court sets out the brie?ng schedule for this Motion, if necessary. Trina Health of Montana v. Healthcare Service Corp. Order Denying Preliminary Injunction 18 F. Other Issues. Although BCBS briefed the scope of the injunction and adequacy of bond, because the Court has declined to issue an injunction, these issues are meet and are not addressed. cause For the foregoing reasons, IT IS HEREBY ORDERED: l) Plaintiffs? request for a Preliminary Injunction is 2) The parties shall, within twenty-one (21) days of the date of this Order, ?le simultaneous briefs addressing: a. Propriety of Declaratory Judgment (and addressing the two issues identi?ed above); b. Arbitration. DATED THIS 1 day of March, 2018. Elizabeth A. Best District Court Judge cc: Erin F. MacLean/Laurie Zmrzel dej Kimberly A. Beatty/Daniel J. Auerbach 0 Kiwi?? Trina Health of Montana v. Healthcare Service Corp. Order Denying Preliminary Injunction - l9 atlpa?es listed beiow. by US. Mall. persmal delivery. e-mail or attorney?s mailbox within the Clerk of Courts 0mm this 51h day of March .13_ . . - . . . Is to certify manna wit-lie dominant was duly served on . ni H011 Elizabeth Best