Administrative Closure Alleged Inappropriate Prescribing of Controlled Substances and Alleged Abuse of Authority Tornah VA Medical Center Tonal), WI MCM 201 1-04211-81-0267 Background The VA Of?ce of inspector General Office of Healthcare lmpeetions (Olil) 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 DEV). 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, 20ll and a September. 2011 report from the Chief Medical Of?cer (CMO) on remedial actions taken). - Anonymous complaints made in August. 2011. via a letter sent to the OK: and Congressman Ron Kind of the US. House of Representatives. 0 A physician at the facility in March. 2012. while the inspection was actively ongoing. By several anonymous reSpondents to an EAR survey in May. 2012, that was conducted prior to a regularly scheduled CAP inspection. A tatal of 32 speci?c allegations were made by these sources. several of Which came to light at various points while the inspection was underway. The scepe of our review included the assessment of the practice patterns and controlled substance prescribing habits of Dr. and?j Y. as well as the administrative interactions of Dr. 2 with subordinates and his approach to clinical leadership. speci?cally as these related to issues around the prescribing of controlled subsrances. We also looked for any concerns by Fedora! and municipal law enforcement authorities or other signals of drug diversion relazed to the practices of Dr. mam Y. Because of the potential seriousness of ?ch allegations and their origination from multiple sourc- we performed at: WW Clean - MCI 8 201 1-0?2 124110267. Tm VMI Tami WI exits! review of the individual practitioners named. Because of the allegations of criminal a ti wit}. our efforts throughout this inspection were closely coordinated with the 5 Criminal Investigation Division We tea-zestee' documents from VA and non-VA sources as follows: Statement of Charges, Settlement Agreement and Fina! Order from a state Medical Ix? Board concerning charges brought against Dr. shortly after his date of appointment to the VA. Letters fret: :12: Veterans Integrated Service Network (VISN) 12 Director and the 12 CMO. . Five peer reviews, and correspondence from Dr. to the Peer Review Oversight Committee and the VISN [2 regarding allegations made in March, 20?, and subsequent actions by VA Wt. Scope ofpraCtice documents and routine peer reviews (Y. Mas: Case incex records of [9 cases at Tomah VAMC since 2009 Ten peer rev?eus 77' 7's prezriee ?re?ned in 90?, tier; minutes of a tree?s! senior the Peer Ravi-3v. Ctr-trainee, related est. 2 mt! :he Committee. Tcmah VAMC police reports of overdosesfsuspectcd overdoses for a three-yea.- period. Reports on adverse drug reactions in patients treated by Dr. and compiled by the Tomah VAMC pharmacy. Documents related to the suicide of Tomeh 'v'AMt.? professional immediately following termination of employment (mentor-ands. e-ntail "usages. Sheri?s Department reports. union representation records and related internal union correspondence). 10. Documents related to the appeal of a terminated Tomah VAM to the II. l2. Clinical Practice Guideline Merit Syaems Protection Board (MSPB) (appellant?s brief for MSPB jurisdiction, narrative oexperiences, supporting materials for decisions). Relevant Medical Center Memorandn on pain management. chronic opioid use. and adverse drug event surveillance. on Management of Opioid Therapy for Chronic Pain (May. 2010). VA Ollie-e cf inspector General I Page 2 Administrative Closme - MCI I 20114042t2Ml-0287. Toman VMC, Tainan. Wl We also requested Tomah VAMC police reports on sales of prescribed or illegal drugs on the Tomah VAMC campus in the preceding three years but were told there have been no Uniform Offense Reports of such activities. We conducted general chart reviews as follows: Patients who were speci?cally identified in complainants' allegations. Patients who were included in June, 20! peer reviews of Dr. Z's practice. A patient pm Who was identi?ed by an informant to Tornah municipal poficc as being involved in drug 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 md compiled the results using a SharePointQ-based data entry tool and Microsoft Exceldb spreadsheet as follows: 1. All patients in the care of Dr. 7. random who were among the loo patients at TOmal't 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; l5 were patients of Dr. and/om. We collected an e-mail dataset for review consisting of 227.532 unique e-mail messages and 859 associated ?les originating from l7 individuals. This review was perfonned using Clearwell software. We searched terms that could signal pctential drug seeking behavior. such as those related to early re?lls and urine this screens. in order to assess what was being communicated about these topics. as well as what advice or were being given. We also reviewed messages pertaining to specific individuals in cases where administrative/supervisory con?icts were reported to exist. We reviewed several extensive Microsoft Excel?~based datasets derived from pharmacy records with assistance hunt the VISN 12 Pharmacy Executive as follows: 1. Early re?lls of controlled substances and mtidepressants (for camparison) at Tomah VAMC over the period of January 1. 201 to September 12, 20l2. 2. Total morphine equivalent amounts of epioids dispensed during FY 2012 in all VISN 12 facilities by site. provider. and patient. VA Of?ce General Page 3 WW Gowre- MCI 2011-04212-Hl-0287, Tallulah VAMC. Tartan. We conducted telephone interviews prior to a site visit. including: 1. The complainant in the case where he/she was not anonymous. 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 identi?ed by complainants as having key information, including 8K: 3 physician. and four 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 staffs roles in facilitating patient safety and appropriately dispensing controlled substances. We provided the consultants with access to recordings of the inten'iews with the four pharmacists who had previ0usly left Tomah VAMC. We conducted a site visit at the facility on from August 22-23. 20l2 -l2. 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. aD Specialist. Dr. 7. mm v. During the site visit. we toured the outpatient pharmacy to assess security issues that had been raised in interviews. We also met with the Acting Chief Information Of?cer to dscuss obtaining e-mail ?les that we were unable to retrieve 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 traf?cking at the Tomah VAMC. However. the Tomah police department reported suspicions that certain Tomah VAMC patients were VA O?ice of inspector General Page 4 Will-Sm Closure - MCI 2011-04212-Hl-0287. VAMC. Tcmalt WI 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 phannacists whom we interviewed expressed concerns regarding the facility's (and ultimately Dr. Z's) expectations for dispersing opioids and other controlled substances. One pharmacist. a new employee, was not retained by the facility at the canclusion of his/her initial employment period. This individual reported that on three occasions he/she had refused to ?ll 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. they had to fill 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 patiean, Dr. 2 would become angry and would insist that this pharmacist discipline the other pharmacists under his supervision. We did nor substantiate the allegation that Dr. 2 was mismanaglng a patient with complex regional pain by attempting to arrange an inappropriate above the knee amputation. In the context of having obtained multiple contradictory facts and statements during 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 n0t substantiate the allegations of abuse of authority. intimidation and retaliation when staff question controlled substance prescription practices. we did find that these are widely held beliefs and concerns among most pharmacy staff and among some other staff. Additionally. during the course of their investigations of a few deceased veterans they had noted large quantities of prescribed controlled substances in their (the veterans') residences. However. no law enforcement seams were being taken. Early in lhis inspection we became aware that the DEA was actively investigating complaints or inappropriate prescribing and drug diversion at the Tornah VAMC. VA Office of Inspector General Page 5 Administrative Closure - MCI 3 201 l-O42i2-Hl-O287. Toman VAMC. Tornah, Wt We found that the Chief of Pharmacy reports to Dr. by virtue of his (Dr. Z's) administrative leadership position. We found that some patients at Tomah VAMC had a pattern of early re?ll requests, which can be a potential risk behavior fer substance abuse. Pharmacists expressed a reluCtance to question such early re?lls. Review of a VISN l2 pharmacy leadership data analysis indicated that Dr. 1m. and other clinicians at the Tornah 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 re?ll? 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 treatment was initiated with the patient. For example, we found in a general chart review of a selected case treated that multiple negative UDS UDS that did not show 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 Arril, 2012. The remaining four patients had no UDS performed during this time interval spanning more than three years, although all were treated chronically with opioids (hiring 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 con?rm that they were actually taking their prescribed medication. We did not substantiate the allegation 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. Of the patients lacking opioid contracts, Dr. 2 was a primary prescriber of opioids for none, ant?CJY was a primary prescriber of Opioids for two. Several allegations dealt with general over prescription of narcotics at the hcillty. and speci?cally alleged over prescription by Dr. deY. 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's history. currem . . VA O?ice of Inspector General Pawn Admnistrative Closure - MCI is 2011-04212-Hi-0267. Tornah VAMC. Tomah. WI 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 subatantiate the allegations that opioids were prescribed inappropriately to speci?c individuals or in inappropriate doses. However. based on the analysis depicted in Tables and 2 below. we determined that the amomts of Opioids prescribed by Dr. in aggregate and to individual patients were at considerable variance cornpared with most opioid prescribers in 12. Table below shows prescription drug data prepared by 12. Table 1. Morphine Equivalents Prescribed by each VISN 12 VAMC Station in FY 12. Unique Total Morphine Average Daily Morphine Total Patients with Equivalents/Unique Equivalents Dispensed Morphine Opioid Patients with Opioid {Total Morphine Station Equivalents Prescriptions Prescriptions Eguhvalents/SGS dagL 575' 36,845,093 3171 11,619 100,945 585 28,976,019 3570 8.116 79.381 578 66,811,245 91? 7.307 183.053 607 42,341,117 5893 7.185 116.1153 556 21,668,793 3390 6.392 59.367 695 51.9%.879 9888 5,258 142,440 537 02,127,193 8662 4.863 115,417 As shown in Column 1 for FY l2. the range among l2 facilities for total morphine equivalents was 2l,668,793 to 66,814,245. Tomah was ranked 5th (highest to lowest) of the seven facilities in VISN l2. Column 2 indicates that the facility has the smallest number of patients treated with Opioids, which in part may reflect the smaller size of the overall patient population at the facility relative to larger facilities in VISN l2. Column 3 indicates the total morphine equivalents per unique patients treated with opioich. Tomah VAMC ranks highest in this category.? 12 provided similar data on a provider level for providers throughout VISN l2. For total morphine equivalents prescribed in FY law was highest in the VISN Tomah VAMC 'lt is possible that the: numbers may not be directly COMIC since h'ger heilities with more extensive surgical acutely frames with mller opioid doses. However. data presented suggest this may not he the entire explanatim. it can be 2222:! Earn 5: 23-1: :91: tats: amount ofopioids prescribed in aggregate at the Tomah VAMC is .ucs. Page 7 Administrative Clown - MCI 3 201 1-04212-1?11-0287. Tomah VAMC. Tornah. WI among 3206 providers who wrote prescriptions for opioids. Dr. 2 was the seventh highest Opioid preseriber in VISN 12. and am Iat Tomah VAMC was the highest prescriber. These three providers accounted for 33.3% of all morphine equivalents prescribed at Tomah VAMC in 12. Table 2. Ten highest individual VISN 12 clinician prescribers (by morphine equivalents270 Data for the ten highest individual prescrihers in the are shown in Table 2. Considering these ten highest prescribers. three were from Tomah VAMC, while two other facilities had two providers each. and the remainder had one or none. Among these ten highest prescribers in the the total morphine equivalents prescribed for the one year period ranged from 2,427,161 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 amounts prescribed; the total morphine equivalents prescribed was more than double that prescribed by the tenth higiest prescribcr in the and morphine equivalents per unique patient was more than threefold higher. On a per patient basisw prescribed 29.264 morphine equivalents per patient (second highest among 12 clinicians) during FY 12; for Dr. Z. the number was comparable (25,142; fourth highest among 12 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 ?'om patient to patient. Nevertheless, it seems clear that the total amount of Opioid and opioid per patient prescribed tum and .n cr?inspertor General 938? 3 mm Cloatrre - . Tartan VAMC. Tm Dr. are at considerable variance compared with most opioid prescribers in VISN 12. and the data support that notal opioid prescribing for one additional individual prescriber at the facility is likeWise unusually high. We did not substantiate the allegation that ?Opioids are contraindicated for PTSD. but this is part of (Dr. Z's] treatment plan." in review of patient medical records. emails, and timing the course of our interviews we did not find 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 ofopioids for treatment of pain. At the time of our site visit. Tomah VAMC leadership reported that a Pain Management Committee met on a basis. 'lhe Committee was covchaired byY and a primary care physician with a background in pain management. Other members inclutkd another physician with a background in pain management. Dr. as an adjunct member, a On: co-chair told us that the Committee addresses mainly administrative issues but that individual clinical cases were addr? by a group of clinicians. This smaller grOup consisted arm! the and possibly a member of nursing staff not affiliated 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 Directm of Pharmacy. Summary and Conclusions We did not substantiate the majority of allegations made in the various complaints that (NO 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 find any conclusive evidence af?rming 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 further review. in particular, we noted that the amOunts of opioid equivalents prescribed by Dr. andE?Y. both in aggregate and per individual patient, were at censidcrabie variance compared with most Opioid prescribers in the VISN. and that a Tomah was 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. 23' inspector General Page 9 MW Closuro- MCI 32011-04212-Hl-0267. Tornah VAMC. Tm. WI it would seem more clinically appropriate for such complex patients to be treated by a specialist or subspeclalist in their particular condition, rather than 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 cmcems about potential safety issues or aberrant patient behaviors. From a 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, such collaboration provides a system of checks and balances that reduces medication errors and enhances general patient safety. and is especially irnportant in this 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 re?lls) because they feared reprisal, even though most of them could not give a first-hand account 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 about 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 Dr. misuses his authority to compel acquiescence with his clinical decisions. For patients with complex oncology problems, hospitals o?en have committees known as tumor boards. comprised of clinicians from multiple disciplines (oncology. surgery, radiation Oncology. nursing, nutrition among others) mat 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 of the facility Director and VISN management, as follows: 0 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. VA Of?ce of Inspector General Page 10 Clown - MCI 2011-04232-Hl-0287. Tomah VAMC. Tainan, Wl The facility Director should review the reporting structure in the context of safeguarding bi-directional clinical discourse from actual 0r perceived administrative constraint. 0 The facility Director should ensure 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. 0 The facility Director should consider some variant of the tumor board model as one potential avenue by which to foster collaborative interdisciplinary management when presented with very complex clinical pain cases. 0 The VISN should conduct further evaluation and monitoring of relative and case-speci?c opioid prescribing at Tomah VAMC on both a facility and individual clinician level. I concur with the recommendation for administrative closure of this inspection. The material in this repon will be briefed to VISN l2 Senior Staff including the VISN l2 Director and CMO, and to Tomah VAMC's Director. A report of contact from that brie?ng will be appended to this administrative closure. Based on our review. am administratively closing this case. .l HN D. DAlGli. JR, MD. Assistant Inspector General for Healthcare lnSpections VA Of?ce of Inspector General Page