Department of Veterans Of?ce of Inspector General Washington, DC 20420 -- August as, 2014 Mike Helbick Of?ce of US. Senator Tammy Baldwin 633 W. Wisconsin Avenue Suite 1920 Milwaukee, WI 53203 Dear Mr. This is in response to your Freedom of Information Act (F OIA) request dated August 11, 2014 in which you asked for a copy of OIG reports dealing with prescription practices at the Tomah VAMC on behalf of United States Senator Tammy Baldwin. Your request was received in this of?ce on August 11, 2014. We have assigned FOIA Tracking Number 14-00966-FOIA to your request. Please refer to it whenever communicating with VA about your request. We have enclosed a copy of the requested records. However, we are all information which, if disclosed, would constitute a clearly unwarranted invasion of an individual's personal privacy under FOIA Exemption 6, 5 U.S.C. 552 Specifically, names, job titles and other information which could reveal the identity of individuals mentioned in the records have been withheld. We do not ?nd any public interest that outweighs the privacy interests of the Individuals. You may. appeal this decision within 60 calendar days of the date of this determination by submitting a signed, written statement by mail, fax, or email. You may submit your appeal by using either of the following addresses or fax number: US. Department of Veterans Affairs Of?ce of Inspector General Of?ce of the Counselor (SOC) 810 Vermont Avenue, NW. Washington, DC 20420 (Fax) 202.495.5859 The appeal should include: - 1. The name of the FOIA Qf?cer 2. The date of the determination, if any 3. The precise subject matter of the appeal If you choose to appeal only a portion of the determination, you must specify which part of the determination you are appealing. The appeal should include a copy of the request and response, if any. The appeal should be marked "Freedom of Information Act Appeal". Sincerely, ?3 Chief, Information Release Of?ce Enclosures Closure Alleged Inappropriate Prescribing oi? Controlled Substances'and Alleged Abuse ofAuthority Tomah VA Medical Center 4' Tomah, Win Background The VA Of?ce of Inspector General (01G) Of?ce of Healthcare Inspections conducted a review to assess the validity of multiple allegations made by a series of complainants. Common elements among the concerns included alleged misprescribing and diversion of opioid drugs by a high ranking physician at the facility (Dr. Z) and by a .Y). as well as abuse of administrative and clinical authority by Dr. Z. The various allegations were compiled from: A complaint made. in March, 20? by a facility (with a corresponding response in June, 20]] and a September. 2011 report from the Chief Medical Of?cer (CMO) on remedial actions taken). 0 Anonymous complaints made in August, 2011, via a letter sent to the and Congressman Ron Kind of the US. House of Representatives. 0 A physician at the facility in March, 20l2, while the inspection was actively ongoing. By several anonymous respondents to an EAR survey in May, 20l2, that was conducted prior to a regularly scheduled CAP inSpection. A total of 32 speci?c allegations were made by these sources, several of which came to light at various points while the impection was underway. The scope of our review included the assessment of the practice patterns and controlled substance prescribing habits of Dr. and. Y, as well as the administrative interactions of Dr. with subordinates and his approach to clinical leadership, speci?cally as these related to issues around the prescribing of controlled substances. We also looked for any concerns by Federal and municipal law enforcement authorities or other signals of drug diversion related to the practices of Dr. and. Y. Because of the potential seriousness of the allegations and their origination from multiple sources, we performed an AOf?ce ofinspector General - u? W- I. - Pagle? Administrative Closure rt 2011?04212-Hl-0267 Tomah . . criminal activity, our efforts throughout this inspection were closely coordinated with the; Criminal Investigation Division -- - We reviewed documents from VA and non-VA sources as follows: 1. Statement of Charges, Settlement Agreement and Final Order from a state Medical Board concerning charges brought against Dr. shortly after his date of appointment to the VA. 2. Letters from the Veterans Integrated Service Network (VISN) 12 Director and the VISN 12 CMO. 3. Five peer reviews, and correspondence from Dr. to the Peer Review Oversight Committee and the VISN l2 regarding allegations made in March, 2011, and subsequent actions by VA management 4. Scope of practice documents and routine peer reviews fom?t'. S. 016 Master Case Index records of 9 cases at Tomah VAMC since 2009. 6. Ten peer reviews of Dr. Z?s practice performed in November, 2009, along with minutes of a subSequent special session of the Peer Review Committee, and related behvecn Dr. and the Committee. Tomah VAMC police reports of overdoses/suspected overdoses for a three-year period 8. Reports on adverse drug reactions in patients treated by Dr and-Y compiled by the Tornah VAMC pharmacy-Z 9. Beaumonts related to the suicide of a Tornah professional . if. . immediately following lamination of employment (memoranda; e-mail messages, Sheriff?s Department reports, union representation records and related internal union correspondence). 10 Documents related to the appeal of a terminated Tornah to the Merit Systems Protection Board (MSPB) (appellant?s brief for MSPB jurisdiction, narrative of? experiences, supporting materials for decisions). ll. Relevant Medical Center Mcmoranda on pain management, chronic opioid use, I and adverse drug event surveillance -- l2. Clinical Practice Guideline on Management of Opioid Therapy for Chronic Pain (May, 2010). V?omceonnspector g?n?r?i . .. Page: Administrative Closure omah .- We also requested Tomah VAMC'pblicc reports on sales of'pr'e'scribed or" illegal drugs on the Tornah VAMC campus in the preceding three years but were told there have been no Urn ferm Offense Reports of such activities. We conducted general chart reviews as follows: 1. Patients who were speci?cally identi?ed in complainants? allegations. 2. Patients who were included 111 June 2011 peer retrieves of Dr. Z's practice. 3. A patient ol-Y who was identi?ed by an informant to Tomah municipal police . as being involved 111 drag diversion. 4. Selected individuals from a list of the 100 patients at Tomah VAMC receiving the highest doses of Opioids We also performed structured chart reviews and compiled the results using a SharePoint?~based data entry tool and Microsoft Excel? spreadsheet as follow: .All patients in the care of Dr andlor-Y who were among the 100 patients at Tornah having the highest doses of opioids (32 cases) 2. Patients on a list provided by the Tomah municipal police department of individuals suspected of drug crimes, who were receiving prescriptions for controlled substances from any provider at Tomah (24 cases; 15 were patients of Dr. and/or-Y] J. We collected an e?mail dataset fer review consisting of 227,532 unique e? ?mail messages and 859 associated ?les originating 17 individuals. Thisreview wasperforrned -. using Clearwell software. We searched terms that could . behavior, such as those related to early re?lls and urine drug screens, .in order to assess -- -- what was being communicated about these topics, as well as what advice or instructions were being given. We also reviewed messages pertaining to speci?c individuals in cases where administrativefsupervisory con?icts were reported to exist. We reviewed several extensive Microsoft Excel?gbaseddatasets derived from pharmacy records with assistance from the VISN 12 Pharmacy Executive as follows: 1. Early re?lls of controlled substances and- antidepressants (for comparison) at Tomah VAMC over the period of January l, 201 1 to September 12, 2012. 2. Total morphine equivalent amounts of opioids diSpensed doring FY 2012 in all VISN 12 facilities by site, provider, and patient. VAomce onnspemrcenem . . . We conducted telephone interviews prior to a site visit, including: 1. The complainant in the case ?(here he/sh'e'iv'cis scientiriy?iaas.? 2. Tomah and Milwaukee municipal police of?cials; a Diversion investigator From the Drug Enforcement Administration (DEA), United States Department of Justice. 3. Current and former Tomah VAMC staff who were identified by complainants as having key information including a pharmacists 4. The newly appointed Director of Tomah VAMC. We also engaged the assistance of three pharmacist consultants to assist us in evaluating the clinical and administrative aspects of Dr. Z?s interactions with pharmacy staff and the staff?s roles in facilitating patient safety and appropriately dispensing controlled substances. We provided the consultants with access to recordings of the interviews with the four pharmacists who had previously le? Tomah VAMC. We conducted a site visit at the facility on from August 22-23, 20 2 -12. We interviewed the Associate Director (the Director was on sick leave), the Chief of Staff, the Mental Health Associate Chief of Staff, the Chair of the Pharmacy and Therapeutics Committee, the Director of the facility?s Opioid Workgroup, the facility?s Police Chief, the Pharmacy Director, the Outpatient Pharmacy Supervisor, two clinical pharmacists, six outpatient staff pharmacists, one contract diSpensing pharmacist, three two primary - care physicians, a physician?s assistant, a? specialist, Dr. Z, and? During the site visit, we toured the outpatient pharmacy to assess security issLJes that had' been raised in interviews. We also met with the Acting Chief Information Of?cer to discuss obtaining e-mail files that we were unable to'retrich remotely; Following the site visit, we conducted several additional interviews by telephone as follows: the Medical Center Director, the Director of Human Resources, and the VISN Pharmacy Executive -- Findings We did not substantiate allegations that the Tomah municipal and Milwaukee police departments made complaints about drug trafficking at the 'l?omah VAMC. However, the Tomah police department reported suspicions that certain Tomah VAMC patients were VAOf?ce .. . .. . ..an84 Administrative Closure til-0257? omah VAMC omath -- - a physician, and four misusing their prescribed controlled substances in various ways including drug?~- diversion.? We substantiated the allegation that at least ?ve outpatient pharmacy staff left the facility in recent years. Pharmacists reported various reasOns for leaving." The four pharmacists whom we interviewed expressed concerns regarding the facility's (and ultimately Dr. Z's) expectations for dispensing opioids and other controlled substances. One pharmacist, a new employee, was not retained by the facility at the conclusion of his/her initial employment period. This individual reported that on three occasions hefshe had refused to fill prescriptions for controlled substances due to concerns about patient safety and/or drug diversion. A second clinical pharmacist who left the Tomah VAMC reported feeling inappropriately blamed by Dr. for the suicide of a patient. A dispensing pharmacist, relatively new to the facility, reported that he believed there were 40-50 patients who were regularly presenting to the outpatient pharmacy for early re?lls of opioids, and that pharmacists were told by Dr. 2 they had to ?ll the prescriptions. He feared this would place his license at risk. A clinical pharmacist who had been hired in a supervisory capacity reported that when some of the pharmacists expressed discomfort with dispensing high doses of opioids to patients, Dr. 2 would become angry and would insist that this pharmacist discipline the other pharmacists under his supervision. We did not substantiate the allegation that Dr. 2 was mismanaging a patient with complex regional pain byatternpting to arrange aninappropziate above knee amputation. in the context of having obtained multiple the_. course of this inspection, often based on second or third hand accounts, we did not .. substantiate allegations of abuse of authority, intimidation and retaliation when Staff question controlled substance prescription practices. While we did not substantiate the allegations of abuse of. authority, intimidation and retaliationwhen staff question controlled substance prescription practices, we did ?nd that these are widely held beliefs and concerns among most pharmacy staff and among some other staff. Additionally, during the course ofthcir investigations of a few deceased veterans they had noted large quantities of prescribed controlled substances in their (the veterans?) residences. However, no law enforcement actions Were being taken. Early in this inspection we became aware that the DEA was actively investigating complaints or inappropriate prescribing and drug diversion at the Tomb VAMC. VA Of?ce of Inspector General I I Page We found that the Chief of Pharmacy reports to? Dr?" by virtue of his-(Dr. - administrative leadership position. We found that some patients at Tornah VAMC had a pattern of early refill requests, which] can be a potential risk behavior for- substance abuse. Pharmacists expressed a reluctance to question such early re?lls. Review of a VISN 12 pharmacy leadership data analysis indicated that Dr. Z, and other Clinicians at the Tomah VAMC prOVided more than 7 days early controlled substance re?lls. A pre April 2012, local facility policy did not allow exceptions to the ?no early refill" rule. A newer policy does not prohibit exceptions but does not provide practical guidance, parameters, or processes by which to approach early re?lls or navigate the clinical complexity of such exceptions. We substantiated the allegation that negative urine drUg screens (UDS) are not acted on and that controlled substances are still prescribed in the face of a negative UDS. In the course of our review of selected case histories and from the structured medical record review, we found that for some patients, when a UDS was performed and showed absence of prescribed medication, documentation in progress notes did not always acknowledge this or indicate what. if any, clinical intervention or change in treatmetit'_? was initiated with the patient. For example, we found in a general chart review of a selected case treated by-Y that multiple negative UDS UDS that did not 'Siibw' presence of prescribed medications) were not acted on. In our structured medical record review, 52 of 56 patients had UDS performed at least one time between_..January, 2009, and April, 20l2. The remaining fouT'p'atients had no UDS performed during this time interval spanning more than three years, although all were treated chronically with opioids during this period. Of the 52 patients who had UDS performed at least one time between January, 2009, and April, 20l2, there were ?ve patients who were being prescribed opioids at the time of the negative test the test failed to confirm that they" were actually taking their prescribed medication. - We did not substantiate the allegatioo that opioid contracts are not being ?encouraged" by Dr. Z. We found that 48 of 56 patients in the structured mediCal record review had an opioid contract. 0f the patients lacking opioid contracts Dr. was a primary prescriber of Opioids for none, and-Y was a primary prescriber of opioids for two. Several allegations dealt with general over prescription of narcotics at the facility, and speci?cally alleged over prescription by Dr. Z. and The appropriateness of prescribing opioids to a particular patient or the appropriateness of a particular dose utilized is a complex matter that must take into account the patient' 5 history, current VA Office General .. Page 6 medical and status, social situation, and other factors; The clinical decision making Underlying this process is based on the practitioner?s clinical judgment and other factors that vary from patient to patient. in this context, we did not substantiate the allegations that opioids were prescribed inappropriately to speci?c individuals'or in" inappropriate doses. .. However, based on the analysis depicted in Tables I and 2 below, we determined that the amounts of opioids prescribed by Dr. and-Y in aggregate and to individual patients were at considerable variance compared with most opioid prescribcrs in 12. Table 1 below shows prescription drug data prepared by VISN 12. Table 1. Morphine Equivalents Prescribed by each VISN 12 VAMC Station in FY 12. Unique Total Morphine Average Daily Morphine Total Patients with EquivalentSIUnique Equivalents Dispensed Morphine Opioid Patients with Opioid (Total Morphine Station Equivalents Prescriptions Prescriptions - - Equivalents/365 daysL 6%2 36,345,093 3171 11,619 100,945 585 28,974,019 3570 8,115 79,381 578 66,814,245 Bled 7,307 183,053 607 42,341,211? 5893 7,185 116,003 556 21,668,793 3390 6,392 59,367 695 51,990,679 9888 5,258 142,440 53? 42,127,193 8662 4,863 "115,417 As shown in Column 1 for FY 12, the range among VISN 12 facilities for total morphine equivalents was 21,6 68,793 to ranked'Sth [high?est't'olowesl) the seven facilities in VISN 12. Column 2 indicates that the facility hasthe smallest number of patients treated with opioids, which" in part may re?ect the smaller size of the overall patient population at the facility relative to larger facilities in VISN Column 3 indicates the total morphine equivalents per unique patients treated with opioids Tomah VAMC ranks highest in this category._ VISN 12 provided similar data one provider level for providers?throughout 12; For total morphine equivalents prescribed in FY l2,-Y was highest in the VISN ?Tornah VAMC ?lt IS possible that these numbers may not be directly comparable since larger facilities with more extensive surgical and emergency treatment services likely have more patients that are treated acutely for short time frames with smaller opioid doses. However, data presented suggest this may not be the entire explanation. It can be conclusively stated from ?lable is that the total amount of opioids prescribed an aggregate at the Tomah IS in the middle ran -e com - and vvith other \tlSN 12 facilities. VA Office ofinspector General . .. Page 7 among 3206 providers who wrote-prescriptions for Dr. was the seventh highest Opioid prescriber in VISN 12, and alum?) -- - 3 lat Tomah VAMC was I the fifth highest prescriber These three providers accounted for 33 3% of all morphine equivalents prescribed at Tomah 1n FY 12. Table 2. Ten highest individual VISN 12 clinician prescribers (by morphine equivalents) in FY 12 Equivalence Determined Total Quantity Dispensed In FY12 Station TotatMorphEguiv UniquePats TotalMorphineEqulv AveDaityMegDigpansed Total Morph Eq?Jnique Rx P16 Tatai M01131 Dave 676 .11 5,326,011 132 29,264 14,592 585 4,213,039 366 11,511 11,543 573 4,162,634 271 15,360 11,405 537 3,310,090 311 12,251 10,439 676 3,734,272 332 11,243 . 10,231 565 3,439,265 340 10,263 9,560 676 (Dr. . 3,213,133 123 25,142 3,317 573 3,159,204 50 63,134 3,655 556 2,721,641 107 25,436 7,457 695 2,427,161 270 3,939 6,650 Data for the ten highest individual preseribers in the VISN are shown in Table 2. Considering these ten highest prescribers, three were from Tomah while two other facilities had two providers each, and the remainder had one whom. ?Among these ten highest prescribers 1n the VISN, the total morphine equivalents prescribed for the one year period ranged from 2, 427, I61. to 5,326,011 morphine equivalents, and morphine__ equivalents per unique patient ranged from 8,989 to 29,264. Thus, even among these ten highest individual prescribers, there was considerable variation ..in.am0unts..prescribed; the total morphine equivalents prescribed HWY was more than double that prescribed by the tenth highest prescriber 1n the VISN, and morphine equivalents per unique patient was more than threefold higher On a per patient basism prescribed 29,264 morphine equivalents per. patient (second, highest among VISN 12 clinicians) during FY 12; for Dr. Z, the number was comparable (25,142; fourth highest among VISN l2 clinicians). Patient populations can vary from facility to facility, complexity of patient case mix can vary from provider to provider, and individual patient characteristics and needs vary from patient to patient. Nevertheless, it seems clear that the total amount of Opioid and opioid per patient prescribed by-Y and VA Of?ce 61 Inspector General Page 3 Closure #2011-04212?Hl?0267 Tomah VAMC Tomah Dr are at considerable variance compared with most opioid prescribers 1E1 VISN 12, and the data support that total Opioid prescribing for one additional individuai prescn ber at the facility 15 likewise unusually high. We did not substantiate the allegation that ?Opioids are contraindicated for PTSD, but this is part of [Dr 2?s] treatment plan In review of patient medical records emails, and during the course of our interviews we did 1101 ?nd documentation that opioids Were being used to treat PTSD. In each case, medical record review indicated a history of a pain related condition and use of opioids for treatment of pain At the time of our site visit, Tomah VAMC leadership reported that a Pain Management Committee met on a basis. The Committee was co- chaired bme and a primary care physician with a background in pain management. Other members included another physician with a background in pain manageman Dr as an adjunct member, 11 One co-chair told us that the Committee addresses mainly administrative Issues but that individual clinical cases were addressed by a smaller groUp of clinicians. This smaller group consisted of?Y, the We) and possibly? a' member of nursing staff not af?liated with the committee. An opioid work group was in the process of being formed. The focus of the work group was to establish surveillance of clinician prescribing patterns. The planned work group included the members of the Pain Management Committee with the addition of the Director of Pharmacy. Summary and Conclusions We did not substantiate the majority of allegations made in the various complaints that received. Although the allegations dealing with general overuse of narcotics at the facility may have had some merit they do not constitute proof of wrongdoing We did not ?nd any conclusive evidence af?nning criminal activity, gross clinical incompetence or negligence, or administrative practices that were illegal or violated personnel policies. Nevertheless, our inSpection raised potentially serious concerns that should be brought to the attention of VISN 12 management for furiher renew. In particular, we noted that the amounts of opioid equivalents prescribed by Dr. andm?t?, _both in aggregate and per individual patient, were at considerable variance compared with most opioid prescribers in the and that a Tomah Iwas likewise prescribing an unusually high total Opioid amount. Additionally, while it is true that certain clinicians may be treating patients with unusual conditions that require unconventional treatments, inspector eral i i I .. Page 9 it would seem more clinically appropriate for such complex patients-to be treated by a specialiSt or subspecialist in their particular condition, rather "than z. Also of concern was the dysfunction of multidisciplinary collaboration in patient care that we observed, particularly between the pharmacy staff and Dr. Z. Perceptions of abuse of authority. intimidation and retaliation are problematic in themselves because they diminish or even preclude the willingness to communicate concerns about potential safety issues or aberrant patient behaviors. From systems perspective, facility leadership, staff, and ultimately patients and their safety, bene?t when there is an environment of communication, collaborative care, approachability, and functional checks and balances. When effective, stich collaboration provides a system of checks and balances that reduces medication errors and enhances general patient safety, and is capecially important inthis setting given the quantities and dosage of opioids that are being utilized in seriously ill patients. The facility appeared to be at a functional impasse with respect to such collaboration. The pharmacy staff uniformly indicated that they were reluctant to question any prescription ordered by Dr. or any aberrant behavior by his patients (for example, frequent requests for early refills) became they feared reprise], even though most of them could not give a ?rst-hand acmunt of negative actions toward them by Dr. 2. For his part, Dr. complained that pharmacists (except for one) were unwilling to approach him with problems or concerns and were uninterested in learning more abom his treatment approach and rationale The Chief of PharmaCy reporting'to Dr. by virtue of Dr. Z?s administrative leadership position may complicate the perception that --misuses--his authority to compel acquiescence with his clinical decisions. - For patients with complex oncology-problems, hospitals often have committees known as tumor boards, comprised of clinicians from multiple disciplines (oncology, surgery, radiation oncology, nursing, nutrition among others) that convene periodically to discuss and recommend an integrated plan for patients with complex cases of cancer. There are several suggestions that?should be brOUght to. the attention ofmthemfacility' Director and VISN management, as follows: a The facility Director should implement a vehicle by which clinicians and staff can openly and constructively communicate concerns and rationale when disagreements arise concerning dispensing of opioid prescriptions. A Office of inspector General Page 10 (bile) . 1r. Closure 21 1-04212-Hio267. irony-nwr- . - The facility Director should review the reporting structure in the centext of safegnarding .. -. . hiwdirectional clinical discourse from actual "or perceived administrative constraint. The facility Director shotild amine?development of guidance, parameters, processes, or a specialty clinic based mechanism to assist clinicians and staff with managing complex patients requesting early opioid re?lls. The facility Director should consider some variant of the tumor board model as one patential avenue by which to foster collaborative interdisciplinary management when presented with very complex clinical pain cases. a The VISN should conduct further evaluation and monitoring of relative and case-speci?c opioid prescribing at Tornah VAMC on both a facility and individual clinician level. i concurf with the recommendation for administrative closure of this inepection. The material in this report will be briefed to VISN [2 Senior Staff including the VISN l2 Director and CMO, and to Tomah Director. A report of contact from that brie?ng will be appended to this administrative closure. I Based on our review. I am administratively closing this case. i HN o. DAIGH, JR, MD. Assistant InspectorGeneral for Healthcare . an era) Page I 1 VA Of?ce aimlnpeot