BEFORE THE MEDICAL BOARD OF CALIFORNIA DEPARTMENT OF CONSUMER AFFAIRS STATE OF CALIFORNIA In the Matter ofthe First Amended) Accusation Against: FRANK D. LI, M.D. Case No. 800-2016-024505 . . Physician's and Surgeon's OAH No. 2018041058 Certi?cate No. A69092 Respondent DECISION The'attached Proposed Decision is hereby adopted as the Decision and Order of the Medical Board of California, Department of Consumer Affairs, State of California. This Decision shall become effective at 5:00 p.m. on November 1, 2018. IT IS so ORDERED October 2, 2018. MEDICAL BOARD OF CALIFORNIA 467% Ronald Panel A BEFORE THE MEDICAL BOARD OF CALIFORNIA DEPARTMENT OF CONSUMER AFFAIRS STATE OF CALIFORNIA In the Matter of the First Amended Accusation Against: Case No. 8002016024505 4 FRANK D. LI, M.D., I OAH No. 2018041058 Physician?s and Surgeon?s Certificate No. A69092, Respondent. PROPOSED DECISION Administrative Law Judge Diane Schneider, State of California, Of?ce of Administrative Hearings, heard this matter on August 2, 2018, in Oakland, California. Supervising Deputy Attorney General Jane Zack Simon represented complainant Kimberly Kirchmeyer, the Executive Director of the Medical Board of California, Department of Consumer Affairs. Michael J. Khouri, Attorney at Law, Khouri Law Firm, APC, represented respondent Frank D. Li, M. D., who was present. The record closed and the matter was submitted on August 2, 2018. FACTUAL FINDINGS 1. On July 1, 1999, the Medical Board of California (California Board) issued Physician?s and Surgeon?s Certi?cate No. A69092 (Certi?cate) to respondent Frank D. Li, MD. The Certi?cate was in full force and effect during the events set forth below. Respondent?s Certi?cate expired on January 31, 2017, and is delinquent. Additionally, respondent?s Certi?cate is also suspended, effective August 5, 2016, pursuant to Business and Professions Code section 2310, subdivision based upon the suSpension of respondent?s medical license in Washington. I 2. On April 17, 2018, complainant Kimberly acting in her of?cial capacity as Executive Director of the Board, issued a First Amended Accusation against respondent. The Accusation alleges that respondent?s California Certi?cate is subject to discipline because of actions taken by the Washington Medical Quality Assurance Commission against respondent?s license to practice medicine in the State of Washington. Respondent requested a hearing, and this hearing followed. Action by the Washington Medical Quality Assurance Commission 3. 011 January 31, 2008, the State of Washington issued to respondent a license to practice as a physician and surgeon. On July 14, 2016,1 respondent?s license was summarily suspended by the washington Medical Quality Assurance Commission (Washington. Commission), due to public safety concerns stemming from respondent?s ownership and operation of multiple pain management clinics. 4. On March 28, 2018, the Washington Commission issued a Stipulated Findings of Fact, Conclusions of Law, and Agreed Order (Agreed Order). The Agreed Order resolved, the pending statement of charges against respondent.2 At the time that respondent entered into the Agreed Order, his Washington license had been suspended for over 21 months. 5. The Agreed Order contains over nine pages of factual ?ndings chronicling respondent?s provision of dangerously substandard care to patients who suffered from chronic pain. Factual Findings 6 through 8 below summarize the findings contained 1n the Agreed Order. 6. Respondent is Board-certi?ed in anesthesiology and pain medicine. Respondent was the Medical Director and sole shareholder of the Seattle Pain Center (SPC), which operated eight clinics in the State of Washington. As the owner of the SPC, - respondent established office practices, treatment and training. SPC represented itself as a treatment center that employed highly trained practitioners who used best practices to find treatment alternatives to narcotic pain medication. Respondent, however, hired newly - licensed mid- level practitioners, such as advanced registered nurse practitioners and phys1cian assistants, to treat patients. Patient records revealed that the clinical practices of respondent and SPC providers repeatedly fell below the standard of care in chronic pain management and the practice of medicine 7. - The Washington Commission investigated respondent?s treatment of 18 patients, identi?ed as Patients A through R. The death certi?cates for 16 of these patients listed acute drug intoxication as a cause or likely contributing cause of death. Respondent 1 On the same day, a statement of charges was also filed against respondent. 2 The Agreed Order also resolved other pending complaints against respondent as well as any future complaints received by the Washington Commission for the same conduct and within the same time period set forth in the Agreed Order. 2 failed to evaluate the nume1ous patient deaths and did not have a policy 1n place for reviewing patient deaths. 8. The medical records for Patients A through established multiple violations. of the standards of care, including: a. Respondent and SIPC providers failed to perform adequate medical examinations and review patients? medical histories and imaging studies to determine if an immediate need existed for. Opioid therapy. b. Respondent failed to conduct risk assessments to mitigate patient harm, drug abuse, diversion and addiction; he. failed to consider other co-morbidities, including mental health problems, substance abuse and other conditions that contraindicated the use of opioids; and, in prescribing large quantities of Opioids, he failed to consider the potential for drug diversion and the risk to public safety. These omissions exposed his patients to multiple risks including overdose, addiction and death. - c. Respondent failed to adequately de?ne a treatment plan in which alternative therapies were considered for pain management and referrals were made to other specialists. d. -In spite of repeated evidence of drug abuse or diversion, as re?ected by failed urine drug screen tests, requests for early medication re?lls, inconsistent pill counts, obtaining opioid prescriptions from other providers, and admitted drug misuse, respondent consistently failed to enforce treatment compliance. e. ReSpondent failed to hire, train and manage experienced pain management p1oviders, and review patient 1eco1ds for standard of care concerns attributable to his staff and medical providers. 9. The following aggravating factors were noted: The gravity and repeated . patte1n of unprofessional conduct, which re?ected a disregard of patient health and safety for patients A through R, who were highly vulnerable to overdose and death, due to a variety of medical and mental health conditions, the potential for Injury, stemming from respondent?s practice of hiring inexperienced health care providers, and then failing to train and supervise them; and, his failure to address aberrant behaviors such as drug abuse, diversion and overuse of medications. Respondent lacked regard for patients? safety by failing to evaluate SPC practices to help reduce the number of patient deaths. 10. Pursuant to the Agreed Order, respondent?s license was suspended for 12 months. (This suspension was in addition to the suspension that respondent had served since July 14, 2016. In July 2019, and upon his completion of ethics courses, respondent may petition for reinstatement. If respondent? 8 license 13 reinstated, his license to practice will be placed on p1obation for 10 years from the effective date of the Agreed O1de1. If respondent is placed on probation, he must treat his patients within the standard of care and abide by other conditions, including: He is prohibited from practicing as a pain management 3 physician; respondent may not be involved in pain management centers. Respondent may only practice in the'areas of anesthesia and interventional pain management; in so doing, he may only perform procedures thatlare medically necessary and preauthorized, and he must make a written arrangement with another physician for patients who may require hospital admission after any procedure. Additionally, respondent may not prescribe opioids except for acute pain and for a maximum of seven days with no re?lls Respondent must also undergo a competency assessment. Respondent must also submit to practice reviews and report adverse events. Respondent must also register with the Washington Prescription Monitoring Program, successfully complete a prescribing course, and present a paper in which he explains how he intends to apply what he learned about addiction and alternatives to long-term opioid therapy in his medical practice. Respondent may petition to modify (but not terminate) the Agreed Order after ?ve years of full compliance, following the effective date of the Agreed Order. The Washington Commission has the sole discretion to grant or deny respondent?s petition for modi?cation. Respondent evidence 11. Respondent received his medical degree from the University of North Carolina in 1997. Respondent completed a one-year internship in internal medicine, in 1998, at Pitt County Memorial Hospital. He completed a residency in anesthesiology, in 2001, at the University of California, at Irvine, and a fellOwship in pain management in 2002, at the University of California, at Los Angeles. Respondent owned and operated the SPC from 2008 until his license was suspended by the Washington Commission. Respondent also worked in California as a pain management consultant for a medical corporation owned by Lawrence Miller, MD. According to respondent, Dr. Miller had a contract to provide pain management services to Steven Brourman, M.D., who operated the California Orthopedic and Hand Specialists, in Beverly Hills. Respondent provided consulting services until August 2016, when his Certi?cate to practice medicine in California was suspended. 12. Respondent explained that in practicing pain management he wanted to treat underserved populations of patients, particularly those who came to him as ?high dose? opioid patients, in order to increase their functionality and mitigate the risks involved in taking opioids. Respondent prides himself on being a caring and competent doctor. He' regards taking care of patients as a privilege. He agrees with the Washington Commission?s goal of reducing the risks involved in- Opioid treatment. Respondent stated that, through his practice, he was able to reduce large numbers of deaths from opioid abuse and enable many patients to 310p using opioids completely. 13. With respect to the Agreed Order, reSpondent made it clear that he? respects? the decision of the Washington Commission and? ?intends to follow it.? Respondent, however, appears to have two views about his misconduct: On one hand, he stated that he ?disagrees? with the Washington Commission?s opinion, and settled this disciplinary matter in order to avoid the cost and stress of defending himself; on the other hand, he acknowledges that ?hindsight is 20/20? and that he could have ?improved his care of patients.? Respondent views his suspension period as an ?opportunity to re?ect on his 4. practice.? He plans to focus on educating himself in order to become more effective in his ?eld. I 14. The entire disciplinary process in Washington, from the suspension to losing his pain management clinics, has tremendously impacted respondent. He explained that he experienced denial, depression, and ?nally, acceptance. Although he did not seek medical treatment for what he describes as he was able to regain stability from the support of his church and family, and by getting a dog. 15. Respondent would like to return to California and practice general medicine, without writing any prescriptions for opioids. He believes that he is competent to treat patients in internal medicine, due to the ?overlaps? between pain management and internal medicine. Additionally, he wants to practice in California in order to be closer to his family. 16. In 2017, an investigator with California Board contacted respondent in order to obtain a patient?s records from Dr. Miller?s of?ce in Beverly Hills. Respondent, who had rendered treatment to the patient, referred the California Board to Dr. Miller?s of?ce manager, Jenny Martinez. The investigator contacted respondent several times due to dif?culties obtaining the medical records from Dr. Miller?s of?ce. Respondent maintained that he ?cc?d? Martinez with the investigator?s request and called Dr. Miller?s of?ce, only to learn that he had moved. Respondent did not follow up by calling Dr. Miller?s new of?ce location. Respondent explained that in his View, it was the responsibility of the custodian of records, and not his, to provide the patient?s medicalreco1ds to the California Board. Respondent also expressed surprise that the California Board had not received the medical records from Dr. Miller?s of?ce. . 17. As of June 28, 2018, respondent?s address of record with the California Board was in Beverly Hills. In April 2018, counsel for complainant informed reSpondent that his address of record was not correct. She told him that he needed to update his address of record to re?ect his correct address in Seattle, but he did not do so. 18. Masami Hattori, M. D. ,is a friend and colleague of respondent and testi?ed at hearing regarding his 1mpressions of respondent? 3 character and abilities as a physician. Dr. Hattori 18 Board- certi?ed in pain management and practices in the Bay Area. Dr. Hattori met respondent when they were residents at the University of California, at Irvine. In the years following, they became friends and also consulted with each other regarding their pain management patients. He describes respondent as a ?dedicated, caring physician who has done a lot for his patients.? Dr. Hattori expressed the utmost con?dence in respondent?s ability to safely practice as a pain management physician. Although Dr. Hattori was aware that respondent?s license to practice medicine had been disciplined by the Washington Commission, he had not reviewed the Agreed Order, and he was not sure of'the basis for the discipline. 19. Respondent also submitted letters of support from physicians who are familiar with his work as a pain management physician in 'Washington. The authors of these letters 5 describe respondent as a well-trained, hard-working, competent and caring physician. It _is noted that a number of the physicians who Wrote letters in support ?of respondent expressed the View that respondent was unfairly targeted by the Washington Commission for political reasons, in order to satisfy the public that of?cials were taking action to curb opioid abuse, and not because his care was truly substandard. 20. This is respondent?s ?rst disciplinary matter before the California Board. LEGAL CONCLUSIONS The standard of proof applied in making the factual ?ndings set forth above is clear and convincing evidence to a reasonable certainty. 2. Business and Professions Code3 section 141, subdivision applies generally to licenses issued by agencies that are part of the Department of Consumer Affairs, such as the Board. It provides, in relevant part, as follows: For any licensee holding a license issued by a board under the jurisdiction of the department, a disciplinary action by another state . .-. for any act substantially related to the practice regulated by the California license, may be a ground for disciplinary action by the respective state licensing board. The disciplinary action of the Washington Commission was based on acts substantially related to the practice of medicine. (Factual Findings 5 through 9.) Accordingly, cause eXists under section 141 to take disciplinary action against respondent?s Certi?cate. 3. Section 23 05, which applies Speci?cally to licenses issued by the Board, provides in relevant part as follows: The revocation, suspension, or other discipline, restriction, or.- limitation imposed by another state upon a license or certi?cate to practice medicine issued by that state . . . that would have been grounds for discipline in California of a licensee under this chapter, shall constitute grounds for disciplinary action for unprofessional conduct against the licensee in this state. The ?ndings contained in the Agreed Order, set forth in Factual Findings 5 through 9, constitute cause for disciplinary action in California for unprofessional conduct 22344), 3 All references are to the Business and Professions Code unless otherwise indicated. 6 and for prescribing without appropriate examination 2242, subdivisiOn Accordingly, cause exists under section 2305 to take disciplinary action against respondent?s Certi?cate. Disciplinary considerations 4. As cause'for discipline has been established, the appropriate level of discipline must be determined. The Board?s Manual of Model Disciplinary Orders and Disciplinary Guidelines (Guidelines) (12th ed., 2016), recommends, at a minimum, stayed revocation and ?ve years? probation, subject to appropriate terms and conditions, for respondent?s unprofessional conduct under sections 2234 and 2242, subdivision The maximum discipline is revocation. In determining whether or not a licensee is suf?ciently rehabilitated to justify continued licensure, it must be kept in mind that, in exercising its licensing functions, protection of the public is the highest priority of the California Board. The California Board seeks to ensure that licensees will, among other things, be completely candid and worthy of the responsibilities they bear by reason of their licensure. . The outcome of this case, therefore, turns on whether respondentis rehabilitated to the extent that he can be trusted to practice medicine in a manner consistent. with public safety. At the outset of this analysis, it is noted that respondent has not been previously disciplined by the California Board, and he presented letters from physicians and the testimony from Dr. Hattori, who think highly of him. Respondent?s misconduct in the instant case, however, is particularly egregious: He engaged in a pattern of providing substandard patient care as the treating physician and as the Medical Directorand owner of eight pain management clinics. Respondent?s misconduct evidenced a disregard for patient health and safety, thereby placing many patients at risk of overdose or death. Patients A though were vulnerable patients when they sought treatment at respondent clinics; and out of the 18 patients identi?ed 1n the Agreed Or,der the death certi?cates for 16 of the patients listed acute drug intoxication as a cause or likelycontributing cause of death. Respondent remains suspended by the Washington Commission until July 2019, at which time he may apply for reinstatement on probation. In the event the Washington Commission reinstates him, he will be placed on a period of probation, during which'time he will be prohibited from, among other things, practicing as a pain management physician. Given the nature and extent of respondent?s misconduct,?in order to remain licensed, respondent must makean extremely strong showing of rehabilitation for the California Board to conclude that he can be trusted to practice safely. It is found that he has failed to meet this heavy burden. Respondent acknowledges the propriety of the action taken by the Washington Commission. He sincerely wishes to resume practicing medicine, a profession he respects, 4 Section 2234 authorizes the California Board to take disciplinary action against a licensee for unprofessional conduct 5 Section 2242, subdivision provides that prescribing dangerous drugs ?without an appropriate prior examination and a medication indication, constitutes, unprofessional conduct.? - enjoys, and views as a privilege; At thesame time, however, it appears that respondent has__ net fully come to terms with his misconduct. And, as complainant observes, respondent did not present evidence that he has engaged in rehabilitation efforts such as participating in a competency assessment or training, shadowing reputable colleagues, or taking prescribing courses. While respondent asserts that he will cooperate with any terms of probation imposed by the California Board, 'complaintant correctly observes that respondent?s failure to facilitate the production of a patient?s medical records, when requested to do so by the California - Board, raises fresh concerns regarding his ability or willingness to comply with terms of probation imposed by the California Board. Under these circumstances, protection of the public requires revocation of respondent?s Certi?cate. Respondent may apply for reinstatement of his Certi?cate three years from the effective date of the Order of revocation imposed in this matter.6 - ORDER Physician?s and Surgeon?s Certificate No. A69092, issued to reSpondent Frank D. Li, M.D., is revoked. August 31, 2018 ?lojfigned by: for DIANE SCHNEIDER Administrative Law Judge Office of Administrative Hearings 6 See section 2307, subdivision .FRANKD. LI, M.D. XAVIER BECERRA Attorney General of California ZACK SIMON FILED Supervising Deputy Attorney General STATE OF CALIFORNIA State Bar No. 116564 was DICAL BOARD OF CALIFORNIA 455 Golden Gate Avenue, Suite 11000 . . San Francisco, 94102- 7004 :?fc??iim@ Telephone: (415) 510- 3521 Facsimile:- (415) 703- 5480 E-mail: Janezack. simon@doi ca. gov Attorneys for Complainant BEFORE THE - . MEDICAL BOARD OF CALIFORNIA DEPARTMENT OF CONSUMER AFFAIRS STATE OF CALIFORNIA In the Matter of the First Amended Accusation Case No. 800?201 6?0245 05 Against. FIRST AMENDED ACCUSATION 8641 Wilshire Blvd, Suite 200 Beverly Hills, CA 90211 Physician?s and Surgeon?s Certi?cate No. A69092, - ?ReSpondent. The Complainant allegesPARTIES . - . 1. I Kimberly Kirchmeyer (Complainant) is the Executive Director of the Medical Board? . of California, Department of Consumer Affairs, and brings this First Amended Accusation solely in her of?cial capacity. i 2. On July 1, 1999, Physician? and Surgeon 3 Certi?cate No. A69092 was issued by the Medical Board of California to Frank D. Li, M. D. (Respondent). The certificate is delinquent, having expired on January 31, 2017, and Is SUSPENDED by virtue of an Order issued on August 5, 2016 pursuant to Business and Professions Code section 2310(a). 1 (FRANKD. LI, MD.) First Amended Accus'ation Ni). 800-2016-024505 15This First Amended Accusation is brought before the Medical Board of California (Board) under the authority of the follovving sections of the California Business and Professions Code (Code) and/or other relevant statutory enactment: A. Section 2227 of the Code provides in part that the Board may revoke, suspend for a period not to exceed one year, or place pn probation, the license of any licensee who has been found guilty under the Medical Practice Act, and may recover the costs of probation monitoring. B. Section 2305 of the Code provides, in part, that the revocation, suspension, ?(5r other discipline, restriction or limitation'imposed by another state upon a license to practice medicine issued by that state, or the revocation, suspension, or restriction of the authority to practice medicine by any agency of the federal government, that would have been grounds for discipline in CalifOrnia under the Medical Practice Act, constitutes grounds for discipline for unprofessional conduct. C. Section 141 of the Code provides: . For any licensee? holding a license issued by a board under the jurisdiction of a department, a disciplinary action taken by another state, by any agency of the federal government, or by another country for any act substantially related to the practice regulated by the California license, may be a ground for disciplinary action by the respective state licensing board. A certified cOpy of the record of the disciplinary action taken against the licensee by another state, an agency of the . federal government, or by another country shall be conclusive evidence of the events related therein. . Nothing in this section shall preclude a board from applying a speci?c statutory provision in the licensing act administered by the board that provides for discipline based upon a disciplinary action taken against the licensee by another state, an agency of the federal government, or another country.? FIRST CAUSE FOR DISCIPLINE (Discipline, Restriction, or Limitation Imposed by Another State)_ . 4. On July 14, 2016, the Washington Medical Quality Assurance Commission (Washington Commission) issued an Ex Parte Order of Summary Suspension regarding 2 (FRANK D. Ll, MD.) First Amended Accusation No. 800-2016-024505 Umom?1:. Respondent?s license to practice medicine in the State of Washington. The Ex Parte Order of Summary Suspension was based on concerns relating to Respondent?s ownership and operation of multiple Seattle Pain Center (SPC) clinics where Respondent and mid- level providers employed by him provided ?_?dangerously substandard care to vuhierable patients suffering from chronic pain conditions?. Multiple-SPC patients died between 2010?2015, some as a result of acute drug intoxication. The Washington Commission determined that summary- suspension of Respondent' Washington license was necessary to address the danger to the public health, safety Or welfare. A Statement of Charges was ?led. I 5. On March 28, 2018, the Washington Commission issued a Stipulated Findings of Fact, Conclusions of Law, and Agreed Order (Agreed Order) to resolve the pending Statement of Charges. A copy of the Agreed Order' 13 attached as Exhibit A. 6. The Agreed Order contains numerous factual findings demonStrating that Respondent I failed to prescribe opioids 1n a safe and responsible manner. Among those factual ?ndings are: Respondent who 1s board certi?ed 1n anesthesiology and pain medicine, acted as mediCal director and sole shareholder of SPC, which had eight clinic locations 1n Washington State. Respondent and the SPC providers he hired repeatedly maintained clinical practices thatwere below the standard Of care in chronic pain management and the practice of medicine. Respondent hired newlylicensed mid-level practitioners who lacked training or expertise in pain management, and failed to properly train or oversee those providers. He failed to evaluate and investigate numerous patient deaths, or to conduct records reviews for standard of care concerns attributable to his employed staff and providers. A review of 19 patient charts revealed multiple violations of the standard of care. For example, patients were prescribed opioid therapy in the absenceof adequate medical examination or objective medical diagnosis. Respondent failed to conduct adequate risk assessments to mitigate patient harm and drug abuse, diversion and addiction, failed to suf?ciently consider co- morbidities or risk factors, or to consider the potential for drug diversion and risl< to public safety when prescribing high doses or large quantities of opioid medication. Respondent failed to formulate adequate treatment plans, reviewaltemative therapies, or refer to other specialists. He failed to consistently enforce treatment compliance 3 . (FRANK D. LI, MD.) First Amended Accusation No. 800-20'16-024505 deSpite repeated signs of drug abuse or diversion, and continued to prescribe even when noti?ed -by other providers of likely drug abuse and potential for patient harm, and in the face of known misuse of medications. A number bf patient deaths were attributed, at least in part, to acute drug intoxication as a cause or likely contributing cause of death. . 7. At the time of the issuance of the Agreed Order, Respondent?s Washington license had been suspended for-21 months. Under the terms'of the Agreed Order, Respondent?s license was suspended for an additional 12 mOnths. He will be permitted to petition for reinstatement in July 2019, after completing ethics courses. In the event Respondent?s Washington license is reinstated, he will be placed On probation for at least 10 years. During probation, Respondent will be prohibited from practicing as a pain management physician, except for interventional pain . management or anesthesia. He will not be allowed to be involved in any pain management centers and will be prohibited from supervising, employing or directing any other medical providers. He must undergo a thorough competency assessment, and will only be permitted to prescribe controlled substances for acute pain in a7 day supply. He will only be permitted to perform interventional pain or anesthetic procedures which are medically necessary and preauthorized, and must make arrangements for any necessary hospital admissions. Respondent will be required to report adverse events and undergo periodic practice reviews. He must utilize the Washington Prescription Monitoring Program, complete a prescribing practices course, and prepare and present a paper emphasizingthe principles of addiction and alternatives- to long term oral opioid therapy. A 8. The Washington Commission noted as aggravating factors the gravity and number of Respondent?s acts of unprofessional conduct which demonstrated repeated patterns of substandard care and disregard for patient health and safety, and failure to adequately supervise staff. Respondent?s patients were noted to be particularly vulnerable to overdose and death due to medical and mental health conditions. Respondent?s practice of hiring newly licensed health care practitioners, inexperienced in pain management, placed his patients at risk for overdose and; death, as did. his failure to address aberrant behaviors such as medication overuse, signs of drug and alcohol abuse, and signs. of drug diversion. - 4 (FRANK D. LI, MD.) First Amended Accusation No. 800-2016-024505 Now Respondent?s conduct and the. action of the Washington Medical Quality Assurance Commission as set forth above, constitute cause for discipline pursuant to sections 2305 and/or 141 of the Code. i i PRAYER WHEREFORE, Complainant requests that a hearing be held on the matters herein I alleged, and that following the hearing, the Board issue a decision: A l. Revoking or suspending Physician?s and Surgeon? 5 Certi?cate Number A69092 issued to respondent Frank D. Li, M. i . 2. Revoking, su3pending'0r denying approval of Respondent?s authority to supervise physician assistants and advanced practice nurses; 3. Ordering Respondent, if placed on probation, to pay the costs of probation monitoring; and I 4. Taking such other and further action as the Board deems necessary and proper. DATED: April 17, '2018 W- KIMBERLY Executive Dire tor Medical Board of California Department of Consumer Affairs State of California Complainant SF2016201386 5 . (FRANK D. LI, MD.) First Amended Accusation No. 800?2016-024505 EXHIBIT . STATEOFWASHINGTON . MEDICAL QUALITY ASSURANCE COMMISSION - In the Matter of the License to Practice - asa Physician and Surgeon of: No. M2016-705 . FRANK D. Ll, STIPULATED FINDINGS OF FACT, License No. CONCLUSIONS OF LAW, AND AGREED ORDER Respondent. 3 The Medical Quality Assurance Commission (Commission), through RICK GLEIN Commission StaffAttorrIey, and Respondent represented by counsel THOMAS H. FAI stipulate and agree to the following. This Agreed Order resolves all cases speci?cally alleged In the statement of charges (2015-4699 and 2015-4708), all complaints received by the Commission before the entry date (the day of Commission acceptance) of this Agreed Order (2016-803? 2016? 8361, 2016-8366. 2016- 8369. 2016-8381. 2016-9182, 2017-8957, 2017-10526 and 2018-2378) and any complaints received by the Commission after the entry date which are detennined to be of the same conduct within the same period of time set forth' in the Findings of Fact and Conclusions of Law. 1. PROCEDURAL STIPULATIONS . 1.1 On July 14- 2016 the Commission issued a Statement of Charges against Respondentthe Statement of Charges, the Commission alleges that Respondent violated (4), (7) (13) (22) and WAC 246-919- 853 -855 -857 and -860. . . - 1.3 The Commission' IS prepared to proceed to a hearing on the allegations' In the Statement of Charges. . 1.4 Respondent has the tight to defend against the allegations' In the Statement of Charges by presenting evidence at a hearing. - 1.5 The Commission has the authority to? Impose sanctions pursuant to RCW I 18,130,160 if the allegations are proven at a hearing. STIPULATED FINDINGS OF FACT - PAGE 1 0s 23 - CONCLUSIONS OF LAW AND AGREED ORDER - NO. - 1.8 The parties agree to resolve this matter by means of this Stipulated Findings . I of Fact Conclusions of Law, and Agreed Order (Agreed Order). . . 1 Respondent waives the opportunity for a hearing on the Statement of Charges if the Commission accepts this Agreed Order.. I 1.8 The factual allegations regarding Urine Drug Screening and the alleged I violation of fraud are not being adjudicated' In this Agreed order and are being deferred to I the attomey general Medicaid Fraud Control Unit. If there Is a subsequent conviction, the . Commission may take further disciplinary action against Respondent. I 1.9 This Agreed Order Is not binding unless it 18 accepted and signed by the Commission. . - 1.10 if the Commission accepts this Agreed Order. it will be reported to the National Practitioner Data' Bank (45 CFR Part 60) the Federation of State Medical Boards? Physician Data Center and elsewhere as required by law. 1.11 This Agreed Order 13 a public document. It will be placed on the Department of Health' 3 website disseminated via the Commission? 5 electronic mailing list and disseminated according to the Uniform Disciplinary Act (Chapter 18. 130 ROW). It may be disclosed to the public upon request pursuant to the Public Records Act (Chapter '42. 56 - RCW). It will remain part of Respondent's ?le according to the state' 3 records retention - law and cannot be expunged. I 2. FINDINGS OF FACT This should be as an Alford Plea. wherein Respondent does not admit to the Statement of Charges but acknowledges that at a hearing before the Commission the State of Washington would present sufficient evidence to prevail on the charges set forth :in the Stipulated Findings of Fact Conclusions of Law and Agreed Order. However the stipulations below shall not be construed as an admission for purposes of any proceeding other than this proceeding. Respondent and the Commission acknovIIledge that the evidence' Is suf?cient to justify the following findings and the Commission makes the following findings of fact: 2.1 On January 31 2008 the state of Washington issued Respondent a license to practice as a physician and surgeon. Respondent" Is board ceItIf' ed In anesthesiology. Respondent' 3 license Is currently suspended. STIPULATED FINDINGS OF FACT. - PAGE 2 or 23 CONCLUSIONS OF LAW AND AGREED ORDER - NO. M2016-705 I I . I - tam-2s; 2.2 Respondent is board certified in anesthesiology and pain medicine and was the Medical Director and Sole shareholder of the Seattle Pain Center (SPC) which had eight (8) clinic locations in Washington Statez'Seattle; Renton: Everett; Tacoma; I Olympia; Spokane; Poulsbor and Vancouver. represented itself as a pain management treatment center focuSed on ?finding treatment alternatives to narcotic pain medications? by incorporating" emerging best practicesf? SPC promoted itself as employing ?ve fellowship-trained physicians and mid?level practitioners with Advanced Registered Nurse Practitioner (ARNP) and Physician Assistant (PA) licenses. SPC - patient records revealed that Respondent and SPC providers repeatedly maintained I clinical practices that were below the standard of care in chronic pain management and I the practice of medicine 2.3 Although SPC was able to hire some mid-level practitioners with experience In pain management, SPC also hired newly licensed mid-level prestitioners without training or expertise in pain management. Respondentallowed those newly hired practitioners to treat patients before establishing insurance accreditation. 2.4" As theowner of SP0 and employer for all the clinic providers, Respondent established oft'ICe practices. treatment protocols, and training; The Commission investigated"Respondent?s treatment of eighteen (18) SPC patients (Patients A through 2.5 The death certi?cates of Patients and lis'ted acute drug intoxication as a cause or likely contributing cause of death. Patient died from a vehicle accident and Patient died from a stroke; however Patients and had multiple serious health Conditions that SPC failed to adequately consider during opiate therapy. Patients A through R?s medical records reveal a pattern of substandard medical care by Respondent' In his individual management of the patient Care and as a Medical Director. An unanticipated patient death" Is a singular, sentinel event requiring immediate critical review for medical and institutional contributions. Respondent did not have a policy in place for morbiditylmortality review. . Inadegu uate Care of Patients A through 2. 6 SPC patient records reveal multiple violations of the standard of care in the following ways: STIPULATED FINDINGS OF FACT. - PAGE 3 OF 23 - CONCLUSIONS OF LAW AND AGREED ORDER - NO. - - Ito?Revere -l 2.6.1 Patients A through R, medicaid enrollees, were referred to SP0 for opioid management and had been on opioids prior to the referral, yet Respondent and SP0 prOviders failed to perform adequate independent. thorough medical examinations whereby an clbjectiire medical diagnosis was made in determining whether the immediate need for'opioid therapy The providers defaulted to Opioid- centric treatment plans at the initial patient visit. SPC providers relied on the patients' subjective complaints and failed to adequately review prior medical histories, imaging studies and specialty consultations. 2. 6. 2 Respondent failed to conduct adequate risk assessments utilizing the tools speci?ed by the lnteragency Guidelines' In order to mitigate patient harm . and drug abuse, diversion, and addiction. Respondent failed to suf?ciently consider co? -morbidities such as mental health problems, prior and current substance abuse and other physical conditions'that contraindicated the use of - opioid medication. Failure to adequately consider and address risk factors prior to opioid therapy place patients at serious risks for respiratory depression Otterdose, continued addiction, and death. Furthermore, Respondent failed to adequately consider the potential for drug diversion and risk to public safety when prescribing high doses Or large quantities of opioid medication. 2. 6. 3 Respondent failed to adequately de?ne a treatment plan for patients where review of alternatiire therapies Was reconsidered for pain - management and referrals were made to otherspeciaiists. . 2.6.4 "Respondent failed to consistently enforce treatment compliance despite repeated evidence cf: failed urine drug Screen (UDS) tests; requests for early medication re?lls; inconsistent pili counts; obtaining opioids from jOther providers; and admitted drug misuse. Under Respondent's oversight as the Medical Director, SPC providers issued ?aberrancy? ?ndings of n_on- compliance. yet there was no consistent enforcement whereby medications were withheld or A the patient discharged from the practice. Compliance was monitored with multiple UDS tests, and results were infrequently retriewed with the patients. FINDINGS OF FACT. I PAGE 23 CONCLUSIONS OF LAW AND AGREED ORDER . . NO. . Ammo; 2.7 7 Patients A l, and were treated by SPC providers under Respondent's management as a Medical Director. As a Medical Director, Respondent was responsible for establishing protocols to ensure safe effective patient care and to ensure that SPO providers Complied with the established protocols. He also had the duty to perionn quality assurance reviews and develop policies and proceddres including: training of clinic staff, evaluating and monitoring the quality of patient care. and identifying and correcting de?ciencies As SPC Medical Director, Respondent failed to hire and experienced pain management provider's. He also failed to - I evaluate and investigate patient deaths, and he failed to conduct records reviews for - standard of care cencerns attributable to his employed staff and providers. . - Patient I - I - I I 2.8 Patient B. Ia 35-year?old woman and homemaker who had a history of cocaine overdose and mental health Issues died on January 25 2010. The death certi?cate listed the cause of death as acute methadone intoxication. Just three days prior Respondent prescribed Patient methadone and Norce. Patient . - . . 2.9 Patient 0, a 50?year-old man, diedIon January 15. 2012, from a heart - attack. However a toxicology report revealed diazepam methadone, and tetrahydrocannabinol (THC) In? Patient C?s blood. Patient obtained treatment at SPC seven times from March 2011 through January. 2012. Respondent saw the patient In - May 2011. Subsequent SPC providers prescribed Increasing? methadone doses of 30 mg to 40 mg daily even after Patient admitted to taking more pills than prescribed had a history of overdose and continued to smoke medical marijuana. Respondent evaluated the patient and failed to adequately act on aberrancies' If! the record, such as inconsistent UDS. Patient E- 2.10 Patient E. a 60-year-old man living' In a residential care facility. was last treated by Respondent In August 2010, and last treated by a PA that Respondent . supervised In April 2011. Patient Edied on August 4, 2011. The death certi?cate listed the cause of death as acute methadone-intoxication. medical records dated April . STIPULATED FINDINGS OF FACT, . PAGE 5 OF 23 CONCLUSIONS OF LAW, AND AGREED ORDER . - I NO. [152016-705 . . 18, 2011, document that Patient had an of?ce- visit for a ?medication re?ll? and received a letter of discharge for violating his opioid agreement. 2.11 SPC medical records document Patient E?s prior drug overdoses and hospitalizations, drug diversion, and illegal buying of prescription'drugs, although Patient did have a valid pain condition due to multiple medical conditions. A PA, - supervised by Respondent, regularly prescribed to Patient oxycodone, Ambien, 'clonazepam, and Fenianyl patches. Two months prior to his last of?be visit, Patient 3 primary care provider informed SPC that oxycodone and Fentanyl patch doses caused -- I breathing dif?culties for Patient The provider also referenced a written . recommendation from the hospitalist to decrease Patient opioid dose because of a recent hespitalization' for drug overdose. . 2.12 Patient F, a 42-year-01d woman, was treated by Respondent" In December 2010. Patient died on December 28 2011. The death certi?cate listed the cause of death as acute combined morphine, and citaloprarn intoxication. Not all of these medications were prescribed by Respondent or SPC providers. Patient had eight total SPC visits between November 2010 and December -,2011 and medical records document a history of depression and requests for increased opiate doses, early re?lls, and use of illegal substances. On December 20 2011, SPO issued a letter of discharge, as well as prescription re?lls for Klonopin and MS Co'ntiIn (morphine) even though her UDS was negative for morphine. Patient I I I . 2.13 Patient G, a 46?year-oldwoman, was last seen by a PA supervised by} Respondent on February 5, 2013. PatientG died on February 20, 2013. The death certi?cate lists the cause of death as acute Idrug intoxication due to the combined effects of methadone, hyIdrOmorphone, nortriptyline, and Citalopram. SPC provider's prescribed. I methadone and hydromorphone. The medical examiner also noted a probable contributory factor of Cardiovascular disease. 2 14- Patient was last seen by Respondent In November of 2012 for an epidural steroid injection, was under the care of Respondent and a PA supervised by Respondent, and for over th0 years the PAprescribed multiple opioids without evidence . . STIPULATED FINDINGS OF FACT, - - . PAGE 6 OF 23 CONCLUSIONS OF LAW, AND AGREED ORDER . - NO.IM2016-705 Ito?mm - .of'reduced- pain or functional improvement. Patient had vague complaints of back - and. leg pain. experienced failed treatment by?her. primary careprdvider and the . University of Washington pain "clinic. and showed little improvement after a series-of six spinal injections. Patient had multiple high risk factors for opiate abuse: repeated complaints of insufficient pain treatment requiring escalating Opioid doses; inconsistent self-treatment with alcohol and medical marijuana; history of-major depression, anxiety, alcohol'abuse and dependency; history of insarceration; and . . disorders requiring hospitalization. She also suffered from multiple physical health co- morbidities whiCh contraindicated the on-going use of chronic opiates: hepatitis cirrhosis (secondary to alcohol abuse). asthma obesity, and seizures. I 2.15 Despite Patient G's risk factors and known medication misuse, the PA prescribed methadone. Norco Dilaudid. and morphine. often at more than 400 morphine equivalent dose (MED) The PA and Respondent failed to exercise more 7 stringent monitoring of Patient G?s medicatiOn compliance. There is no documented attempt to establish an opioid exit strategy despite Patie?ntG?s repeated drug-seeking behaviors and indicators of severe oVer?sedation. There" Is no documentation revealing Respondent?s concerns about the prescribing and management of Patient G. Patient 2.16 Patient a 55-year-old paraplegic woman was seen by Respondent In A December 2010 and subsequently by a PA supervised by Respondent. Patient died 'on May 15 2011. The death certi?cate lists the cause of death as acute drug intoxication due to the combined effects of morphine oxycodon'e. diazepam. trazodone. and gabapentin. SPC providers prescribed MS Contin and oxycodone. Patient suffered from multiple conditions including chronic obStructive pulmonary disorder . (COPD). opioid dependence, and chronic pain. She also had a history of hospitalizations for respiratory failure. Patient had four SPC office visits where . Respondent and a PA he supervised prescribed" Increasing doses of MS Contin and oxycodone at each visit while being aware of Patient H?s high risk factors for opioid misuse. At Patient 3 last of?ce visit on May 13. 2011 the UDS showed benzodiazepines not prescribed by SPC. However. the results of the UDS were not available until May 19. 2011. The PA prescribed MS Contin 30 mg (three times a STIPULATED FINDINGS OF FACT. - PAGE 7 OF 23 CONCLUSIONS OF LAW. AND AGREED ORDER NO. . - Ito-mm? day) and oxycodo?ne 30 mg (225MED). This increase was thoughtIto be reasonable according to Respondent because "the long-acting component was raised-to 90 MED and we knew that she was able tolerate MED of 105 from 3-17-11 to 5-13-1 1. The strategy was to increase her short-acting component so that'she could have more . control over how much she needed above the baseline amount, and refrain from taking them if? not needed or tolerated. Because most of the. increase was in the short acting. as?needed. component, it was thought to be tolerable." E.atn_e_m_4 2.17 Patient a 58-year-old woman was found dead on April 7 2013: The death certi?cate lists the cause of death as acLIte drug intoxication due to the combined effeCts of methadone hydromorphone. tramadol and trazodone. Between September 2012 and January 2013 Patient had four SPC of?ce visits where she obtained opioid therapy. Patient was treated by a PA supervised by Respondent. Patient . 2.18 Patient K, a 54-year-old woman, died at?home on March 11, 2013. The death certi?cate lists the cause 'of death as acute drug intoxication (alprazolam) and additive drug effects (carisprodIol, hydrocodone, and meprobamate). Patient K- had mental health risk factors and prior hospitalizations for overdose. She redeivett pain infusion at SPC. Respondent failed to recognize the documentation' In the record that- indicated Patient K's DAST (Drug Abuse Screening Test) score was consistently elevated. indicating a moderate level of problems related to drug abuse that required further investigation which was not adequately performed. Patient i 2.19 Patient a 62-year-old man, died at home on January 30 2015. The death certi?cate lists the cause of death as bronchopneUmdnia with pulmonary abscesses and Acute opiate intoxication was listed as a contributing condition. Patient died 15 days after ?lling his last prescription for methadone oxycodone, and morphine at more than 1 500 MED. Respondent states that Patient began a ?2 year wean of one pill per day reduction per month" at In April 2014. I 4 Respondent further states that Patient L?s death was [sic] the direct result? of the opioid medications because-SPO had decreased the doses Consistently and gradually. STIPULATED FINDINGS OF FACT, PAGE 8 OF 23 CONCLUSIONS OF LAW. AND AGREED ORDER . - . . NO. I - AO-REV.2-07I Patient . 2. 20 Patient a 36-year-old man died at the hospital on July 26 2011. The death certi?cate lists the cause of death as acute intoxication of the combined effects of methadone. 'citalopram, trazodone and valproic acid. SPC providers prescribed . methadone and morphine. Other conditions ?contributing to death were listed as chronic pain schizoa?ective disorder, and fatty liver disease. Patient began opioid . therapy at SPC in February-2011 when he-obtained morphine prescriptions. Patient had schizoaffective disorder, a history Of physical and emotional abuse, hyperlipidemia,? and chronic pain. Respondent failed to adequately control high risk factors for opioid abuse and misuse and In less than six months Patient was switched from morphine to an escalated dose of prescribed methadone Patient also had a documented failed UDS and documentation of misusing medications prior to receiving methadone prescriptions. I Patient - 2.21 - Patient a 51-year-old man, Was last treated by Respondent in. May 2011. Patient died on July 1, 2012, from acute combined hydrocodone', and methadone intoxication, four days after 1' ?mg his last prescriptions for these medications. Patient had multiple high risk factors for medication abuse and misuse: priorsubstance abuse; bipolardisorder; attention de?cit hyperactivity disorder; taking non-prescribed opibids; and history of abuse. SPC providers documented multiple aberrant behaviors of drug-seeking, but deemed the conduct as not egregious and maintained Patient on escalating opioid doses. Patient 0 2. 22 Patient 0, a 28-year-old woman, died on January 12-, 2011. The death certificate lists the cause of death as acute combined hydrocodone, hydromor'phone, - 'and methadone intoxication. Patient 0 ?lled her ?nal methadone prescription from SIPC just five days prior to her death. . 2. 23 Patient 0 had complaints of knee pain and Respondent initiated a dose of morphine at 75 MED daily. Patient 0 had 11 SP0 of?ce visits over a one-year period and she also Obtained prescriptions for oxycodone. Norco, and methadomne Patient 0 Was morbidly obese, ambulated with crutches and continued to rate her pain level as FINDINGS OF FACT, PAGE 9 OF 23 CONCLUSIONS OF LAW AND AGREED ORIDER . . NO. 002015-705 110-an207 high even while using opioids._ She had a history of signi?cant mental health risk factors -- - - (depression and of abuse), thus she was prone to suffer from chronic pain as a somatic manifestation of emotional sUffering. Respondent did not attribute her pain to chronic pain that can occur in patients with signi?cant histories of- childhood abuse. Patient 0? multiple UDSs were also positive for THC and once for cocaine, and negative for prescribed opioids. Respondent?s continued opioid prescriblng' In light of Patient 0' 'comorbidities and illicit drug use posed serious risks of medication abuse. 2 .24 Respondent documented Patient 0' 5 request for early medication re?lls as "evidence of inadequate pain control.? and does not provide an? early re?ll of requested . oxycodone: instead Respondent prescribed additional opioids methadone and Dilaudid. Treating museuioskeletal knee pain with methadone may be considered I below the standard of care especially whenIhigh risk factors are indicated. I 2.25 I Patient 0?s multiple aberrancies were also indicative of drug-misuse and potential diversion, yet Respondent failed to cease opiate therapy'ortake greater control over the patient?s access to pain mediation by preocribinIg fewer dosage units in a single prescription or similar action. Patient I . . . 2 2.6 Patient Pwas'seen by;Restondent on one occasion in December 2012. Patient was a 58-year-old man who died on May 3, 2013 from' Injuries sustained . when his vehicle veered over a highway median and collided head- -on With a logging truck. A scene investigation revealed a malt liquor can Wedged between Patient 5 leg and the gearshift. State toxicology report indicates the presence of ethanol. oxycodone and tricyclic antidepressants In Patient blood. Patient P's death occurred 19 days after llIng his ?nal prescription from SP0 for oxycodone. 2.27 Respondent, a PA he Supervised, and other SPC providerstreated Patient P?schronic pain by prescribing oxyoodone at 180 MED Ifor?greater than two years without sufficient evidence of improvement. Patient P's referring provider requested a detailed independent medical evaluation of Patient 3 severe post traumatrc headaches, but SPC failed to adequately perform this. Patient was maintained on an oxycodoIne regimen at his request and there was no documented objective diagnosis or STIPULATED FINDINGS OF FACT. 1 PAGE 10 OF 23 CONCLUSIONS OF LAW. AND AGREED ORDER 7 I NO. Ao-Rsvz-cr assessments Patient had depression; hypertensiom and history of stroke. He took more medication than prescribed and requested early re?lis. Respondent did not enforce the need to avoid alcohol during opiate therapy. The two UDSs performed were positive for the presence of alcohol. Respondent and SP0 providers failed to implement an opioid exit strategy knowing that concurrent alcohol use potentiates opioid: side effects. Patient . 2. 28 Patient Q. a 54-year-old man, died on May 24 2014 from hemorrhagic cerebral infarct (stroke). Between March 2012 and May 2014 Respondent, a PA supervisedby Respondent, and SPC providers prescribed escalating doses of oxyoodone and OxyContin. Patient displayed repeated aberrant behaviors; such as inconsistent UDS results and taking more medication than prescribed, yet SPC providers maintained an oxy?codone therapy regimen without adequately addressing - Patient 5 two years of non-compliant medication use. SPC providers. failed to adjust Patient 0? opiate therapy given his serious health conditions including the need for open heart surgery just six months prior to death. Seattle Pain Center Clinical and Business Practices - 2 .29 Respondent on occasion hired ARNPs and PAs with little to no experience or training' In treating chronic nuncancer pain. In fact, these mid- level providers joined SPC by relying on Respondents agreement to provide training In chronic pain treatment. SPC also on occasion hired mid- level providers recently graduated from clinical sChooI and allowed these providers to treat patients and bill for services before obtaining an established National Provider Identi?er number or insurance credential. - 2.30 In 2013, Respondent hired an experienced pain management PA forthe Spokane clinic. Respondent allov?ved the PA to treat patients and bill for services for. several months prior to submission of a delegation agreement to the Commission. Once noti?ed of this requirement, the PA ceased treating patients until the delegation agreement was in place.? A 2. 31 in 2013, the Washington State Department of Labor and Industries I denied ReSpondent' 3 application to renew his provider contract. _s decision was STIPULATED FINDINGS OF FACT - . PAGE 11 0F 23 CONCLUSIONS OF LAW, AND AGREED ORDER . NO. M2015-705 AO-REV.2-DT ..:based oncomplaints-of noncompliant-Aopioid prescribing practices?and :PAis alleged substandard care of an injured worker Ivho eventually .died from drug overdose. Respondent withdrew his application. . 3. CONCLUSIONS OF LAW The Commission and Respondent agree to the entry of the following Conclusions of Law. . 3.1 The Commission has jurisdiction over Respondent and over the subject matter of this proceeding. . I 3 .2 Respondent has committed unprofessional conduct' In violation of IRCW 18.130.180(1) (4), (7) (14), (22) and WAC 246-919- 853 -855I, -857, and -880. 3. 3 The above violations provide grounds for' Imposing sanctions under RCW18.1..30160 . 4 AGREED ORDER Based on the Findings of Fact and Conclusions of Law Respondent agrees to . entry of the following Agreed Order. I 4.1 Suspension of Respondent?s License. Reapondent?s license has been suspended for a period of twenty-one (21) months, beginning July 14. 2016. Respondent?s license' Is SUSPENDED fer an additional twelve (12) months following entry of the Agreed Order. - . 4.2 Petim fer Reinstatement Respondent may petition for reinstatement in July 2019, and after ful?lling the following requirements: 4.2.1 Ethics Courses. Respondent shall enroll' In and successfully complete both the 2. 5-day ProfessionallProblem Based Ethics course and the in-depth follow-up six-month course, the Plus Program. offered by the Center for Personalized Education for Physicians (CPEP). To provision, Respondent must obtaIn an ?unsonditional pass" at the Conclusion of each course.- Respondent will permit CPEP to communicate with the Commission regarding his participation" In the courses and will provide the Commission a copy of the essays the Respondent writes as part of the courses. A failure by the Respondent to obtain an ?unconditional pass? upon completion of STIPULATED OF FACT, PAGE 12 OF 23 CONCLUSIONS OF. LAW AND AGREED ORDER NO. AO- REV. 2-07 --either cou rseworlti may result?in-the Commission requiring Respondent to re?take - the course. Respondent will submit proof of the succesSful completion 'of each course to the Commission within thirty (30) days to the Compliance Of?cer at addresses listed below 1 Medical complianceCdDdohwagov 2. Compliance Of?cer Medical Quality Assurance Commission P. 0. Box 47866 Olympia WA 98504-7866 4.3 Probation Following Reinstatement. Following the CommisSIon? granting of reinstatement of Respondent?s license, the Commission will place . Respondent? 5 license on PROBATION. Respondent? 5 license to practice as a physician and surgeon in the state of Washington is subject to this Agreed Order for a period of at least ten (10) years from the effective date of this Agreed Order. Respondent must fully comply with all of the terms and conditions set forth' In this Agreed Order and Respondent 5 treatment of his patients must meet the standard of care. 4 4 Practice Conditions. Subsequent to the Commission?s granting of reinstatement of. Respondent' 3 license Respondent must comply with the following . conditionsRestriction'on Clinical Patient Care. Respondent is RESTRICTED from practicing as a pain management conSuIting physician perWAC 246-919-860. Respondent' Is restricted from providing any pain management consultations outside of interventional pain management or anesthesia for the duration of this Agreed Order. 4 ..4 2 Restricted from Actinq as a Medical Director. Respondent is RESTRICTED from performing In any way as an owner, operator, medical director . manager andlor supervisor of any pain management center(s). Respondent. further restricted from having a majority interest In any type of diagnostic or biological specimen testing laboratory center and may not- refer his patients. for lab lvvork to a lab? In which he has a ?nancial interest for the duration of this Agreed Order. STIPULATED FINDINGS OF FACT. . - .. I ., PAGE 13 OF 23 CONCLUSIONS oF LAW AND AGREED ORDER - No. macro-705 - Imam 4 3 Restricted from Sugewising? Medical Providers. ?Respondent-' Is RESTRICTED from employing,? overseeing, or directing any other medical providers, physician's, phySician assistants or nurse practitioners for the duration of this Agreed Order. 4 .4. 4 Practice Restriction. Respondent's license' I's RESTRICTED and he . may 2M practice In the areas of anesthesia and interventional pain management under the requirements set forth below. 4.4.5 Competency Aeses$ment Within thirty (30) days of reinstatement of Respondent's license, Respondent will enroll' In a thorough competency assessment which must be presapproyed by the Commission? 3 Medical Consultant. Completion of the evaluation must be accomplished within sixty (60) days of reinstatement of Respondent?s license. The Physician Assessment and Clinicai Education (PACE) program at the University of California San Diego School of Medicine' Is pre-approved. . 4.4.5.1 Respondent must contract with PACE to conduct a complete and thorough competency assessment. The assessment must include screening examinations, including at a minimum history and physical cognitive, and screening. The assessment must also include reviews of Respondents. 5- . actions which resulted In this case; - responses to his patients? negatiue outcomes; - reasoning and decision making; knowledge and understanding of controlled substances especially methadone and other narcotics, including his knowledge of the appropriate use of controlled substances, their risks alone and In combination, and how to document decision making when prescribing controlled substances; . .7 ability to create meaningful and appropriate medical records and evaluate the medical records of his patients? other health care providers; and . - ability to identify his knowledge gaps and implement appropriate responses to any such areas of de?ciency. . STIPULATED FINDINGS OF FACT - - . PAGE. 14 CF23 CONCLUSIONS OF LAW AND AGREED ORDER - NO. . no- - - - information that is requested and must unconditionally cooperate with PACE during the evaluation. Respondent must sign a waiver of - con?dentiality and a release to permit PAGE and the Commission to share- information. The Commission will provide PACE with records from the Commission?s ?les that the Commission deems appropriate. 4. 4. 5. 3 Respondent must authorize PACE to provide a . comprehensive written report, including any third-party evaluation reports. to the Commission. Respondent must ensure that PACE provides its report to the Commission. . 4 ..4 5. 4 Reapondent must follow all recommendations? In 3 evaluation report, including recommendations for educational and other remediation, medical or other treatment, the use of a preceptor, additional? . evaluations indicated by the assessment?s screening examinations, and re?assessment after completion of remediation. Respondent agrees that the recommendations will be incorporated into a modi?ed Commission OrderProof of enrollment, evaluation, and completion of the program shall be sent to the Compliance Unit at the addresses listed In paragraph 4. 2.Limitation on Prescribing Controlled Substances. Respondent may prescribe oral pain medication for acute pain management and provide up to a 7-day supply of such oral pain medication with no re?lls. (See CDC and AMDG guidelines.) Respondent shall not prescribe opioids except for acute pain as described above. Respondent shall not hire or direct anyone else to prescribe. . opioids for his patients.? . 4 ..4 7 Commission Approval of Practice Site. Prior to resuming practice after Respondent's reinstatement In paragraph 4. 2 above, Respondent's worksite must be pre-approved by the Commission or its designate. 4. 4 8 Restrictions to Interventional Pain Practice. Respondent" Is restricted trom performing any interventional pain or anesthetic procedures vvhich '51 FINDINGS OF FACT, ., PAGE 15 OF 23 CONCLUSIONS OF LAW AND AGREED ORDER . . NO. M2016-705 - -- are- telephonic preauthorization for any proposed interventional pain or anesthetic procedures from a Physician Reviewer pre-approved by the Commission or Commission? designee. The Physician Reviewer must be a physician who has an active unrestricted license and Who" Is Board certi?ed by the American Board of Anesthesiology, The American Board of and The American Board of NeIIrology, or the American Board of Physical Medicine and Rehabilitation. The Physician Reviewer -- shall be paid for by Respondent. The case presentation to the Physician Reviewer shall include. . . . - A thoroUthy documented reason the interventicIn is rquIested. - . Documentation of a thorough and complete medical enamination. . - '1 A docUmented discussion-with the patient. of alternative treatments. Documented informed consent to the procedure. lnforrned consent shall include providing a copy of this Agreed Order to the patient or describing the facts and conditions of the Agreed Order In an informed consent form to be pre-approved by the Commission. Post-procedure documentation shall include but not be limited to a description of the patient? improved function or improvementfworsening of conditions after the A procedure. The Commission retains the ability to obtain Respondent?s patient billing records for analysis by the. Physician Reviewer. The charts of the patients for I - whom interventions were, perionhed will be reviewed quarterly by the Physician Reviewer who will submit quarterly reports to the Compliance Of?cer at the addresses listed" In paragraph 4.2.1. The ultimate decision as to whether a procedUre was medically nec?ssary is reserved for the Commission. At its sole . discretion the Commission may modify the preauthor'ization requirement" In. paragraph 4.4.8 at any time upon the Commission? 3 satisfaction that reviewed procedures have been medically necessary and appropriate and preauthon?zation' Is no lenger necessary in view of continuing quarterly revievis. 4 .4. 9 Hospital Admissions. Respondent shall make arrangements with a' physician who has hespital admitting privileges" In the city where any interventional pain procedure" Is to assist with admitting any patientwho requires STIPULATED FINDINGS. OF FACT, I PAGE 16 OF 23 CONCLUSIONS OF LAW, AND AGREED ORDER NO. . - Inc?never)? the admitting physician shall be reduced to writing, and Respondent shall provide - the agreement to the Compliance Of?cer at the addresses listed In paragraph 4.2.1. 4.4.10 Reporting of Adverse Events. Respondent _must report to the Commission and Physician Reviewer any adverse events including, bat not limited to, death, infection or unanticipated hospitalization of any patient. 4.4.11 Notice to Egglover. Respondent must provide a copy of this Agreed Order to his health care employer and ensure that the employer understands the Commission decision' In this case. Within seven (7) days of the start of employment, Respondent will cause his employer to inform the Commission, in writing, of the ?employer?s knowledge of this Agreed Order 4. 5 Practice Reviews. in order to monitor compliance with this Agreed Order, Respondent will submit to periodic practice reviews performed by an entity pre-approved by the Commission or its designee. The Physician Enhancement Program (PEP), through the PACE program referenced' In paragraph 4.4.5, Is ore-approved. Resp'ondent' Is costs aesociated with the practice monitoring program The program will include, but is not limited to, the following components: . - The representative will review the PMP for Respondent to ensure he is in compliance with the prescribing limitation invparagra'ph 4.4.6. - The representative will conduct an on-site visit, including but not limited? to site assessment, longitudinal chart review, interview, patient visit I. observation, and a site visit?every'six months for the duration of the program. - .The representative and Respondent will jointly, create a Personal and Practice Development Plan (PPDP) to educate Respondent on the process I - cf self?managed continuous quality. Improvement and objectively measure 1 - the results. I - The representative will conduct a chart audit, and Respondent will engage in a phone call to discuss progress on documentation, quality of care, and the PPDP. - -- '1 . - The representative will provide the Of?cer listed In paragraph- 4.2.1 with brief summary reports on a basis and a detailed report' 1 hospital- Wadmissi-on during or after any procedure. Respondent's arrangement with STIPULATED FINDINGS OF - PAGE 23 CONCLUSIONS OF LAW, AND AGREED ORDER . N0. M2016-705 7 {Io-Raven - summarizing progress in the program .and further recommendations on a? .I?sm - quarterly basis - - Respondent will participate in a Physicians Universal Leadership Skills Education (PULSE) survey after initial enrollment and after approximately six months to measure improvement. Respondent will maintain waivers of con?dentiality authorizing fu'll exchange of information between the evaluatdr, the practice review entity, and the Commission. The Commission may take additional action, in a Separate case, if the practice review reveals . . ongoing concerns regarding Respondent?s practice. 4. 6 Compliance Orientation. Respondent shall complete a compliance orientation In person or by telephone within sixty (60) days of the effective date of this Agreed Order. Respondent must contact the Compliance Unit at the Commission by calling (360) 236-2763, or by sending an email to: Medical.comgliance@doh.wa.gov within ten (10) days of the effective date of this Agreed Order. Respondent must provide?a .cOntact phone number where Respondent can be reached for scheduling purpOSesPrescription Monitoring Program (PMP) Within thirty (30) days of reinstatement, Respondent will registerwith the Washington Prescription Monitoring Program (PMP), if he has not already done so. Respondent will query the PMP regularly for all patients that he prescribes controlled substances for under the terms of paragraph 4 ..4 6. Respondent will document the PMP 'query in the patients medical record and will . note any evidence of aberrant behavior. 4. _8 Prescribing Course. Within twelve (12) months of the effective date of this Agreed Order, Respondent shall take and successfully complete one of the folloIving courses: A. The ?intensive Course' In Controlled Substance Prescribing," at Case Western Reserve University In Cleveland, Ohio (216) 983-1239. [lease substance). B. "Prescribing Controlled Drugs,? at Vanderbilt University Medical Center, Center for Professional Health, Nashville. Tennessee, (615) 936-0678. l/wwz. mo. vanderbilt. edu/cph/36620). STIPULATED FINDINGS OF FACT, PAGE 18 OF 23 . CONCLUSIONS OF LAW, AND AGREED ORDER NO. M2016-705 . - foams Physician Prescribing Course -?at the- University of? California.- San - - - Diego School of Medicine. (619) 543- 6770. (http: paceprograrn. ucsd .ed aspx). Respondent shall submit proof of the completidn of the CME hours within thirteen (13) months of the effeCtive date of this Agreed Order to the Compliance Off cer listed in A paragraph 4. 2.1. The course shall not 'count towards the credits required to maintain licensure. - . . 4.9 Law: Following completion of the course required in paragraph 4.8, _Respondent.must prepare and submits typewritten paper to the Commission. The paper I I must be a minimum of two thousand (2,000) words. cbntain a bibliography, refer to the course completed in paragraph 4.8. and state how Respondent intends to apply what he teamed in his practice, with a speci?c emphasis on pn?nciples of addiction and alternatives to long-term oral opioid therapy. The paper must be submitted Within three (3) months after completing the related course pUrsuant to paragraph 4 .8 Respondent should be prepared to discuss the subject matter of the written paper with the Commission at his next personal appearance The paper must be submitted to the Commission in both etecuonic and printed format to the Compliance Of?cer listed' In paragraph 4.2.1. - 4. 10 Peer GrougPresentation. Respondent shall organize and present his paper to a peer group with interest' In pain management. Proof of completion attendance; and materials must be submitted to the Compliance Of?cer listed In paragraph 4.2.1. 4.11 Personal Aggarances. Respondent must personally appear at a date and location determined by the Commission' In approximately six (6) months atter reinstatement, or as soon thereafter as the Commission' 5 schedule permits. Thereafter, Respondent must make personal appearances annually or as frequently as the Commission reqLIires unless the Commission waives the need for an appearance. Respondent must participate' In a brief telephone call with the Commission' Compliance Unit prior to the appearance. The purpose of appearances is to provide meaningful . oversight over Respondent?s compliance with the requirements of this Agreed Order. The Commission will provide reasonable notice of all scheduled appearances. 4.12 Pain Management Rules. Respondent will folly comply with the pain management rules fot'Ind at WAC 246- 919- 850 through 863. FINDINGS OF FACT, I . PAGE 19 OF 23 CONCLUSIONS OF LAW AND AGREED ORDER . Iowa; The Commission. has waived. a directfine- . . Respondent given his contemplated large ?nancial settlement with other persons and entities impacted by_ his conduct described in the Findings of Fact.- . 4.14 Mddi?cation. Respondent may petition in writing for modi?cation of this Agreed Order after ?ve (5) years of full compliance following the effective date of this Agreed Order. The Commission will have sole discretion to grant or deny Respondent?s petition. Respondent may petition for modIf' cation but not for termination. 4 15 Obey all laws. Respondent shall obey all federal. state and local laws and all administrative rules governing the practice of the profession' In Washington. 4.16 Compliance Costs. Respondent Is responsible for all costs of complying With this Agreed Order.- 4.17 Violation of Order. If Respondent violates any provision of this Agreed Order In any respect. the Commission may initiate further action against Respondents license up to and including revocation of his license. 4.18 Chan of Address .__i3__e.spondent shall inform the Commission and the . Adjudicative Clerk Of?ce. in writing, of changes" In Respondent?s residential and/or - business address within thirty (30) days of the change. 4.19 Effective Date of Order. effective date _of this Agreed _Order' Is the date the Adjudicative Clerk Of?ce places the signed Agreed Order into the U. 8. mail. if required Respondent shall not submit any fees or compliance do?uments until after the effective date of this Agreed Order. . . 4. 20 Terminatibn. Respondent may not petition to terminate the terms and conditions of. this Agreed Order until at least ten (10) years afterthe effective date of this Agreed Order. When Respondent les such a petition, a date and time will be arranged 4 for Respondent's appearance before the Commission, unless the Commission waives the need for Respondent?s personal appearance. The Commission will have sole discretion to grant or deny Respondent? petition. 5. COMPLIANCE WITH SANCTION RULES 5.1 The Commission applies WAC 246-16-800, et seq to determine appropriate sanctions. Tier of the "Practice Below Standard of Care" schedule, WAC 246- 16-810, applies to cases where substandard practices caused severe harm er death STIPULATED FINDINGS OF FACT . PAGE 20 0F 23 CONCLUSIONS OF LAW AND AGREED ORDER N0. . Ao-Rsvz-Irr m?toa of fthestandardrof care was severe because Patients A through were in vulnerable states when they sought treatrrient from Respondent's clinics. It Is clear that the substandard care provided by Respondent both in his individual capacity and In his failure to oversee the clinic operations as a Medical Director caused severe harm to Patients A through R. (Respondent's failure to adequately supervise his multiple Cciinic sites. failure to'consider'and address risk factors prior to placing Patients A through on opioid therapy, and failure to?properly respond to red ?ags . in continuing opioid therapy far Patients A through fell below the standard of care. in addition to Patients A through there were other patients identi?ed In the cases listed' In the introductory paragraph who were not speci?cally included' In the Findings of Fact section. . 5.2 Tier requires the imposition of sanctions ranging from three years to permanent oversight. Under WAC 246-16- -800(3)(d) the starting point for the duration of the sanctions' the middle of the range. however there Is no middle range for Tier C. WAC directs the Commission to identify aggravating or mitigating factors to detemIine appropriate sanctions. . MITIGATING FACTORS: '9 Respondent has not been the subject of- prior discipline with the Commission. AGGRAVATING FACTORS: The gravity and number of Respondents acts of unprofessional conduct. Med icai records obtained for Patients A through shew repeated patterns of substandard care and disregard for patient health and safety, and failIIre to adequately supervise his staff. The vulnerability of Patients A through R. Patients A through were highly vulnerable to overdose and death due to the various medical conditions and mental health conditions documented' In the medical records. 3 Potential for? Injury to be caused by the unprofessional conduct. Respondent's practice of hiring newly licensed health care practitioners inexperienced In pain management placed his patients at risk for overdose and death. The risk continued with Respondent?s failure to address aberrant behaviors, such as: A FINDINGS OF FACT. . . PAGE 21 OF 23 CONCLUSIONS OF LAW. AND AGREED ORDER - NO. M2016-705 - Ito-seven? - A?m- - and signs of drug diversion through aberrant UDSs. I . insuf?cient regard for patient safety. Respondent displayed insuf?cient regard for patient health and safety despite the number of patient deaths suffered' In his patient popIIlation. Respondent has not produced documentation to indicate that he initiated an evaluation or investigation of SPC practices to help reduce the number of SPC patient fatalities. . 6 Respondent had ultimate responsibility in hiscapac'rty as Medical Director for the patient care provided by the SPC clinics. Respondent held out his clinics to other providers as specialty care for pain management patients and acted as . the Medical Director for eight clinics across the state. However. he failed to properly supervise and train the mid? level staff who performed the majority of patient assessments and management. 5. 3 The gravity of the aggravating factors over the one mitigating factor supports . the imposition of a ten-year oversight period. The sanctions' In this case include a three (3) year suspension. probation for. ten (10) years with license restriction. two ethics courses, a clinical competency assessment and clinical education program, and practice conditions for a five-year period with the ability to modify the Agreed Order after 1' vs (5) years at the Commission?s discretion. Sanctions also include. qLIarterly practice reviews annual compliance appearances before the Commissidn a course on opioids and addiction. training, a paper. and a presentation. These sanctions are appropriate within the range given the facts of the case and the extreme volume and Weight of the aggravating factors. over the mitigating factor. FAILURE TO COMPLY A Protection of the public requires practice under the terms and cenditions imposed In this order. Failure to comply with the terms and conditions of this order may result' In suspension of the license after a show cause hearing. If Respondent fails to comply with the icons and conditions of this order the Commission may hold a hearing to require Respondent to show cause why the license should not be suspended Alternatively, the 5 Commission may bring additional charges of unprofessional conduct under STIPULATED FINDINGS OF FACT, - PAGE 22 OF 23 CONCLUSIONS OF LAW. AND AGREED ORDER NO.M2016-705 . 7 Ito?Raven? .- ROW In either ease, Respondent will be afforded notice and an opportunity for a hearing on the Issue of non compliance. 7 ACCEPTANCE l, FRANK D. Ll, Resoonden?: have read understand and agree to this Agreed Order 'I'h'is Agr?ed Order may be presented to the Commission without my appearance. I undeTst met I reset '0 a 'signed Copy if the Commission accepts this Agreed Order . 33/38" LI MD I DATE RESPONDENT - If? as I THOMAS H. FAIN. - DATE ATTORNDTI RESPONDENT a ORDER The Commission essepts and enters this Stip'utated Findings? of Fact Conclusions of Law and Agreed Order. DATED: . March 28 . (2018, I STATE DFWASHINIGTDN . MEDICAL QUALITY ASSURANCE COMMISSION PANEL CHAIR PRESENTED BY: wseA #23692 COMMISSION STAFF STIPIILAITED FINDINGS OF EADT . PAGE-23 OF 23 CONCLUSIONS or: LAW AND AGREED ORDER NO. M201 6-705 Ao - eat. it?"