ANSWER TO STATEMENT OF CHARGES For Master Case # M2017-463 A. INTRODUCTION WAC 246-919-850 dictates the intent of pain management. It was enacted in January of 2012. It states “The Washington state medical quality assurance commission recognizes that principles of quality medical practice dictate that the people of Washington have access to appropriate and effective pain relief. The appropriate application of up to date knowledge and treatment modalities can serve to improve the quality of life for those patients who suffer from pain as well as reduce the morbidity and costs associated with untreated or inappropriately treated pain.” It further states “The commission recognizes that controlled substances including opioid analgesics may be essential. . .” and “Physicians should recognize that tolerance and physical dependence are normal consequences of sustained use of opioid analgesics and are not the same as addiction.” “Physicians should not fear disciplinary action from the commission for ordering, prescribing, dispensing or administering controlled substances, including opioid analgesics, for a legitimate medical purpose and in the course of professional practice.” Most importantly, “The ultimate judgment regarding the propriety of any specific procedure or course of action must be made by the practitioner based on all the circumstances presented.” Exhibit C: I have dedicated my entire life's work to helping others. My medical and surgical specialty is interventional spine and surgical pain management. I do not have an opioid prescribing practice. I am one of the few independent pain specialists in the country and the only pain specialist in my region that does not have an opioid prescribing practice. There are two other pain clinics in my region that specialize in opioid prescribing among other things. I have also worked with the Department of Health directly to advocate an opioid free practice and develop flow sheets to eliminate opioid use for chronic benign pain. Exhibit D & E: I am recognized as a national leader in the field of surgical interventional spine and pain management. Exhibit D is a compilation of third party testimony confirming that I am nationally recognized as an educator and thought leader in my specialty and that I contribute to shaping the best practices and guidelines for my specialty. I run a program where I educate and train other pain specialists how to transition their practice to an opioid free practice as I have successfully done myself. I operate a national model practice representing how to successfully eliminate opioid prescribing. Exhibit E includes documents confirming this including a schedule of visiting physicians who have recently attended my program on how to eliminate opioid prescribing through the responsible application of other medical technologies that have been proven to work better than oral opioids for pain management. Physicians I have trained in this way range from private practice physicians all the way up to the directors of pain fellowship training programs at major universities across the country. I also lecture throughout the state and nationally to other physicians and physicians in fellowship training on the importance of avoidance and elimination of opioid prescribing for chronic benign pain. I have developed these lectures as a deliberate effort to combat the opioid epidemic. There are few if any practicing physicians who have made the same concerted and significant effort to voluntarily combat the opioid epidemic through education and training. I sit on a national advisory board dedicated to the elimination of opioid prescribing through the use of evidence based medical technology. I was selected to sit on this national board for the very reason that I have successfully eliminated opioid prescribing from my practice and I am an advocate for combating the opioid epidemic. Also included in these exhibits are documents I have created for use by other physicians free of charge so that they too may make progress transitioning their own practices to become opioid free. I run a program where physicians who are not able to visit my practice can schedule a phone call free of charge to review key concepts in the elimination of opioid prescribing in their own practices. I am in a large multispecialty group including many primary care physicians. I spearhead a program that empowers the primary care physicians in my group to deescalate and eliminate opioid prescribing for chronic benign pain. This has been facilitated through shared information with the department of health’s own physician public health director in my region using shared goals and resources. Exhibit A & B: Exhibit A and B is a compilation of letters from patients that were collected on short notice detailing how I have gotten them off of and drastically reduced oral opioid use in the recent past with better outcomes. Specifically, I have included letters from three of the patients listed on the confidential schedule, patients D, E and G. This direct patient testimony refutes the charges being made against me and supports the safe, competent and effective practices that I employ. It is extremely regrettable that many of these charges have simply been copied and pasted out of other cases not related to me and then applied to me without cause and without any meaningful review of the records. This was done simply because I once worked at Seattle Pain Centers long before it was closed down. One need not look very far into my current group of approximately 70 providers or my current hospital system to find the truth and the overwhelming volume of patients I treat without the use of opioids. It is a statement of fact that I have never had an adverse outcome related to any prescription I have ever written and there has never been any risk to the community related to any professional or private action that I have taken. I would also encourage the DOH to contact its own physician agent and public health director in my county. She is familiar with who the opioid prescribers are in my community and she knows that I am not one of them. Below is a summary of the true and correct evidence contained in the actual medical record that directly disproves each of the charges made against me. I have concern that the DOH filed these charges without even the most basic evaluation of the medical record because the content of the medical records directly disputes each allegation. Having to respond to what I believe to be meritless allegations has caused damage to my reputation, career, family, income, and health. B. ANSWER TO SPECIFIC CHARGES 1.1 This paragraph addresses licensure. I admit that on August 26, 2010, the State of Washington issued me a license to practice as an osteopathic physician and surgeon, and that my license is currently active. I also admit that I graduated from medical school in 2005, passed three sets of rigorous board exams on the first try, and completed an Internship in Internal Medicine to obtain this license. 1.2 This paragraph addresses specialized training and marketing. I admit that I specialize in Interventional Spine and Surgical Pain Management. This means I completed a residency in Physical Medicine and Rehabilitation and passed an extensive written and oral board to be Board Certified in this field. I also completed an ACGME accredited fellowship in Pain Medicine and passed a specialized board exam in this specialty to become double board certified. There is no higher level of training available in my specialty and there is no higher level of certification in my specialty. There is no one more qualified in this field. Despite the allegations, there was no adverse outcome related to my treatment in any of the patients listed here. I also admit that I worked at the Seattle Pain Center as an employee for a period of two years, while I was waiting to be hired at The Doctors Clinic. I deny that I had any control over Seattle Pain Center advertising. 1.3 This paragraph addresses the allegation that I practiced in a manner described as an extreme departure from the standard of care. As a physician having completed the highest level of training in the specialty of pain medicine and as a physician holding the highest level of board certification in pain medicine, I have access to the deepest and broadest modalities available to treat pain. All of which have been used in the patients listed and in the safest and most effective way possible and in a way that exceeds the standard of care. In 2012, the CDC estimates that over 259,000,000 opioid prescriptions were written. Nearly all of these prescriptions were written by primary care physicians without any monitoring whatsoever and without the offer of alternate therapies. The level of compliance monitoring and functional monitoring for any patient that I ever prescribed opioids to is of the highest caliber evidenced by medical records and is - by definition exceeding the standard or care. Additionally, the vast procedural pain management options that I am trained to deliver (and applied to the patients detailed below) exceeds simply prescribing pain medications and again exceeds the standard of care. This paragraph alleges that I treated patients in a way that was an extreme departure from the standard of care. At the time of the care at issue, the applicable guidelines were derived from the Agency Medical Director’s Group “AMDG 2010”, not the current version “AMDG 2015.” My standard of care exceeded all criteria in the AMDG 2010 to create a positive, safe and effective plan for each patient. I will remind all interested parties that there has been NO adverse outcome with any of my prescriptions. There has been NO patient complaint from any of the patients mentioned in these charges. In fact, three of the patients (D, E, and G) have written letters in support of my treatment. There has NEVER been a risk to the community based on any action I have ever taken. The evidence for this accusation simply does not exist. Therefore, the allegations in paragraph 1.3 are denied. 1.4 This paragraph alleges that risk assessments were not done. Every patient included in this inquiry had rigorous risk assessments on the initial visit. These are present in the medical record. This included the DAST-10 assessment for drug use and abuse potential, Brief Pain Inventory, possible side effects of medications, mental health checklists, Point of Care urine screens, and urine drug screens sent out for lab evaluation. Patients also filled out a complete pain history including pain onset, injury, scale, level of disability, alleviating and aggravating factors, and all alternative treatments tried including surgery, physical therapy, chiropractic care, acupuncture, TENS unit, massage, hot/cold packs, back brace, psychological therapy, meditation, and non-opiate medications and opiate medications. I also review any interventional treatments including Epidural Steroid Injections, Joint Injections, Medial branch blocks, MILD procedure, Nerve blocks, Radiofrequency nerve ablation, trigger point injections, Kyphoplasty, and Spinal Cord Stimulator. I gathered all previous imaging including X-Ray, MRI, CT, EMG nerve studies. I asked the patients about all other clinicians they have previously seen for pain including primary care, Internal medicine, Orthopedic Surgery, Neurosurgery, Physical Therapy, Neurology, Rheumatology, Psychiatry, Chiropractic care, and Acupuncture and requested records from the applicable providers. I obtained a complete list of all current and past medications and allergies. I obtained a complete medical history, surgical history, family history, and social history and documented in the chart. I documented a complete review of current symptoms and systems. I also obtained a Washington Prescription Monitoring Program report (only available back to 2011), and any other available information from pharmacies. I then reviewed and asked EVERY patient to sign a comprehensive Pain Contract for controlled substances that included pharmacy name and location, agreement to only take prescribed doses, not to share medication, agreement not to use illicit drugs or alcohol while on pain medication, required follow up appointments no longer than every 2-3 months, consent to random urine drug screens, pill counts, no early refills, agreement to only obtain pain medications from one clinic, agreement to safeguard medications in a lock box, and report to police any stolen prescriptions. Patients signed that they were aware that opiate medications may be discontinued if there is no improvement in function and pain, if there are adverse effects, concurrent use of illicit drugs, failure to pass drug screen, recurring emergency department visits for chronic pain management, stealing or borrowing opioids/drugs, aggressive demand for opioids, un-sanctioned dose escalation, or repeatedly losing prescriptions. The pain contract also included CONSENT To Opiate Treatment, including possible unwanted side effects, uncommon but serious side effects, and instruction that side effects may worsen if mixed with other drugs including alcohol. Patients also signed that they were aware opioid medications may cause physical dependency, psychological dependence, tolerance, and addiction. Furthermore, on each follow up visit, patients filled out a DAST-10 screen for medication abuse/diversion, submitted to a Urine Drug Screen, PMP checked, Mental Health screen, and documented benefits of treatment. Patients also reviewed the medication contract, risks of opiates, and consent on each encounter. Therefore, the allegations in paragraph 1.4 are denied. 1.5 This paragraph alleges that I initiated patients on opioids and increased opioid dosing improperly. The allegation that I initiated patients on opioids is entirely false. Every patient, designated as A – I, was initiated on opioids long before I treated them. A very basic review of the records or PMP website confirms this. The charge that I initiated opioids is denied and this can be confirmed with a very cursory review of the medical records or the PMP. This paragraph also alleges that I did not review alternate therapies or make referrals to other specialists. In every patient, designated as A - I, it is clearly documented which non-opioid therapies had been tried, which non-opioid therapies could further be considered, and this was done in every case requiring a referral to another specialist. I performed a review of an exhaustive list of non-opioid therapies at each visit. This evidence is easily confirmed in the medical record. It should also be noted that all patients A - I were required to have a primary care specialist. Examples of alternate therapies offered and delivered to patients A - I and previous treatments that failed patients A - I are easily located in the medical records. Some examples of these are listed here: • Patient A was given cervical epidural steroid injections, physical therapy, a spinal cord stimulator, mindfulness, an opioid taper, Lidoderm, non-opioid medications, lumbar medial branch nerve blocks, radio frequency lesioning, home exercises, spine stabilization exercises, an inversion table, multiple imaging studies, lumbar epidural steroid injection, and referrals to Psychology and Neurosurgery. • Patient B was given non opioid medications, an overall decrease in opioids under my care, intrathecal medications, pain pump reprogramming and decrease, consults for spine surgery, topical non-opioid analgesics, orthotics information and recommendations, a referral to a podiatrist, and a trochanteric bursa injection. • Patient C was given mindfulness, physical therapy, joint injections, consideration of EMG and Hand Surgery referrals, a cervical spine MRI, cervical epidural steroid injections, ice, compression, rest, temporary work restrictors, tendon sheath injections and a topical anti-inflammatory as well as recommendations for anxiety management and autoimmune disease treatment. • Patient D was given a greater than 90% reduction in opioid exposure, thoracic spine imaging, non-opioid medications, non-opioid pump mediations Prialt and bupivacaine, multiple Neurosurgery referrals, removal of dangerous intrathecal medications, cessation of long acting opioids, a sleep study, a Pulmonology/Sleep Medicine referral, a lumbosacral orthosis brace, trigger point injections, mindfulness, an opioid taper, physical therapy, a psychological referral and evaluation, lumbar epidural steroid injection, a spinal cord stimulator trial and implant, a neuroendocrine hormone evaluation and associated resources, spinal cord stimulator reprogramming, pain pump reprogramming and adjustment, and follow up care with his primary care provider. • Patient E was given a Neurosurgical referral immediately resulting in subsequent referrals to Cardiology and the ordering of a Dexa scan, a recommendation to taper opioids, an opioid taper after a massive spine surgery, a referral to a different physician to evaluate the need for lorazepam, a topical analgesic, a referral to primary care for anemia, mindfulness, consideration of indicated non-opioid medications that were not tolerated, consideration of epidural steroid injections and corticosteroids that were not tolerated in the past, and a spinal cord stimulator trial and implant. • Patient F was never seen by me at Seattle Pain Center. Subsequently, at other clinics, while under my care, this patient has been given all indicated forms of injections and non-opioid medications as well as a rheumatology referral. • Patient G received interlaminar lumbar epidural steroid injections, mind body and mindfulness techniques, physical therapy, home exercises, offers for surgical referrals, offer for a spinal cord stimulator, care coordination with other specialists, dietary and nutritional counseling, and laboratory monitoring as it related to interventional pain care. • Patient H was given a spine surgery referral, home exercises, physical therapy, epidural steroid injections, lumbar medial branch block, radio frequency lesioning, a discogram, trigger point injection, discontinuation of sedating long acting opioids prescribed elsewhere, a spinal cord stimulator, an offer for a paddle stimulator lead, an offer for intrathecal medications, depression screening and treatment, non-opioid medications including Cymbalta, Zomig and Zoloft (not at the same time), mind body and mindfulness techniques, Botox, destruction of prescriptions from other clinics, a Neurology referral, a Neurosurgery referral, PTSD screening and the offer of a Psychiatry referral, recommendations on safe doses of Tylenol and NSAIDs, and a topical nonopioid analgesic. • Patient I was given - all on the single visit that I saw her - a safer pain medication, recommendations and instructions for biofeedback, recommendations and instructions for visualization, mindfulness/mind body techniques, and information and recommendations for nerve blocks and neuromodulation. Looking back on this extensive list, taken directly from the medical record, it is inconceivable how any reviewer could miss all of these examples of how I reviewed, offered and delivered alternate therapies and referrals. This paragraph also alleges that I prescribed increasing doses of opioids to patients A-I. Pursuant to the medical records for patients A-I, this is false. • Patient A had been on MED doses as high as 1,176 oral and 11,828 intrathecal concomitantly in the past. MED with me ranged from 195 down to 91 and the dose was appropriately chosen and adjusted based on the responses to other non-opioid pain management procedures. The dosing considerations acknowledged her requirement to function, return to work, and maintain employment. • Patient B in the past had been on MED doses as high as 1,536 oral and also had a pain pump. Her MED oral dose for the duration of the time I saw her was 120, with functional gain and no side effect. This dose did not change and I actually decreased her overall opioid exposure during this same time by decreasing the dose of intrathecal opioid, which was 300 times more potent than oral opioids. • Patient C’s MED was 40. This never changed for the duration that I saw him. Outside my care his maximum MED dose was 120 as calculated by the DOH. • Patient D did require higher than normal MED to function based on his levels of tolerance. I decreased his total opioid exposure by over 90% as detailed elsewhere. I also stopped his long acting opioids. The PMP web site calculates his maximum oral MED outside of my care to have been over 500. The highest oral MED dose I prescribed to him was 270 and this was stable without escalation and allowed him to be able to walk after a spinal cord injury as detailed elsewhere. • Patient E’s medical record clearly documents that I recommended tapering opioids before I assumed her care. She went on to have a massive spine surgery and required humane and reasonable and safe post-operative pain control and increased MED doses. I then tapered opioids in this patient and she continues this taper today facilitated by a spinal cord stimulator that I recently implanted in her spine to decrease pain. The DOH and PMP calculates her maximum MED dose outside of my care to have been 540. When I briefly assumed her care during the absence of her primary physician, the MED was already 280. She then had a massive surgery reasonably and safely requiring the MED to go up to 328 and then I actually began to decrease and taper her doses, a process that continues today. • Patient F had an MED of 90 with functional gains with no side effects and this was after failing a myriad of other pain management options. Her dosing did not change. This patient has a PMP calculated dose, while under the care of other providers, of 960 MED. • Patient G under my care had an MED of 105 and this did not change until I changed my practice to become a non-opioid practice. She has a lifetime history of compliance and functional gain noted after having tried all indicated conservative and interventional options and she had a maximum MED dose while under the care of other providers as high as 245. • Patient H had functional gains and a lifetime history of medical compliance on MED of 90 and this did not change under my care. Her maximum PMP calculated MED while not under my care has been as high as 440. She also tried a myriad of all indicated forms of conservative, non-opioid and interventional and surgical options. • Patient I was seen once and thus she never received increasing or continuing opioid doses from me. I did prescribe MED of 60 and her maximum MED is noted to be 277 according to the PMP website while under the care of other providers. In every instance, patient A - I, I decreased the overall opioid exposure at the appropriate time, did not change it, made safe, responsible and justified adjustments to medications, or did not continue to see the patient. Additionally the DOH itself calculates the maximum MED dose to be significantly higher than I was prescribing in all patients A - I. The accusation that I increased doses in patients A - I is denied, as are all of the allegations in this paragraph. 1.6 This paragraph alleges I failed to perform independent medical exams. The allegations that I did not perform independent medical exams on patients, specifically on Patients E and I, is specifically refuted by the medical records. The initial independent physical exam for Patient E is noted in her initial visit on 7/3/13 and shows objective physical exam evidence for nerve damage from the spine with relevant verbiage stating that straight leg raise is positive bilaterally, lower extremity motor strength is decreased at 4/5, and lower extremity sensory exam is diminished in the left S1 using a Whartenberg pinwheel. Waddell signs are absent, and no overt drug seeking behavior is noted. The interested reader can find the entire exam in her note. This is all consistent with a spinal etiology for pain and nerve damage. This paragraph also alleges that I relied on subjective complaints instead of objectively establishing a diagnosis. This is completely false. Further objective evidence for Patient E’s painful condition exists where I have noted “complaints of radicular pain are supported by chronic findings on recent EMG” (a purely objective test). I go on to reference an MRI (again, a purely objective test) showing post-surgical changes and severe spinal stenosis consistent with neurogenic claudication. Patient E’s diagnoses are based ONLY on large volumes of objective evidence and this is clearly documented for any interested reader and yet again it appears that the reviewer did not review the records. The allegation that I did not evaluate objective evidence is denied. The initial independent physical exam for Patient I on 3/26/13 is clear and present in her initial visit and shows objective physical exam evidence for a painful non-healing surgical wound and painfully tender abdomen consistent with her presentation and complaints of pain. My full physical examination is noted in her record. The accusation that I failed to perform independent medical exams is denied. Also regarding the accusation that I relied solely on subjective complaints, despite the presence of clearly documented physical examinations supporting painful conditions in these cases, it should be noted that the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has published that “Pain is always subjective. Therefore, the patient’s self-report is the single most reliable indicator of pain. A clinician needs to accept and respect this self-report, absent clear reasons for doubt.” It is inappropriate to redefine the standard of care as it pertains to trusting patient reports of pain by attempting to create a standard where patient reports of pain are distrusted and presumed to be false until proven otherwise. Regarding the accusation of prescribing dangerous levels of medications, Patient E had been on significantly high opioid doses not initiated by me and without any side effects or adverse reactions or sedation. Her opioid tolerant state in fact made these doses perfectly safe and necessary in her case after her major spine surgery and in order to prevent life threatening complications of immobility such as DVT/PE or sacral ulcers. There were no side effects and no adverse outcomes and no patient complaints related to any prescribing in this or any other patient Further accusations are made that I defaulted to opioid centric treatment plans referencing Patient E and I. As is clearly documented in the medical record, I recommended surgery and made appropriate referrals for patient E’s pain. Surgery is not an opioid centric treatment. I go on to recommend tapering opioids stating that “the lower the opioid doses are at the time of surgery, the more effective postoperative analgesia efforts will be”. Recommending tapering opioids is not an opioid centric treatment it is quite the opposite. Also, I did not prescribe opioids on the first visit. Not prescribing opioids is not opioid centric treatment. I also implanted a spinal cord stimulator in this patient. Implanting a spinal cord stimulator as I did is not opioid centric treatment. For Patient I, on the one visit I had with her, I recommended injections and neuromodulation/spinal cord stimulator. Both of these are not opioid centric treatments and could not be carried out until her non healing infected surgical wound healed. I also identify that all non-opioid pain medications have failed before considering opioids. This is not opioid centric. She was consented for opioid therapy, a therapy that she was already undergoing, and we also discussed biofeedback and visualization as ways to minimize opioid use. This is also not opioid centric. The accusation that I provided opioid centric treatment is denied and specifically refuted by the medical records. All of the allegations in this paragraph are denied. 1.7 This paragraph alleges that I failed to enforce treatment compliance. I absolutely “enforced treatment compliance” as it pertains to failed urine drug screens, requests for early refills, inconsistent pill counts, and admitted drug misuse or abuse. The specific allegation references patient I and a urine drug screen result that did not yet exist at the time that I saw her. Not included in these allegations are all the patient encounters where I did appropriately “enforced treatment compliance,” as noted below. Urine drug screens were always reviewed and appropriate action was always taken. No patients were ever issued opioid prescriptions after admitting misuse or abuse; this allegation is directly refuted by the medical record. Strict compliance was consistently enforced resulting in termination of opioid therapy and referral to an addiction specialist when appropriate. Every instance of an inconsistent urine drug screen was reviewed with the patient and appropriate action was taken. Early refill requests were not granted. There is no evidence that inconsistent pill counts did not result in appropriate action being taken. Regarding Patient I, this claim states that Patient I had alcohol in her urine drug screen despite stating that she did not drink. It further states that she was not held accountable at the time of the visit and medications were not withheld. It appears that the reviewer is unfamiliar with the difference between the point of care (POC) immunoassay urine drug screen and the confirmatory send out liquid chromatography/mass spectroscopy (LC/MS) urine drug screen that has to be performed at a later date using specialized equipment not available in doctors’ offices. This patient’s POC urine drug screen, the screen available at the time of the visit, was completely consistent with the prescription history and the PMP report and showed oxycodone as prescribed by other physicians. It did not show alcohol. At the time of the visit, the POC UDS in fact did NOT show alcohol. The allegation that “Patient I was not held accountable for the inconsistent UDS at the time of the visit” is denied because this is a false statement. The UDS available at the time of the visit was consistent. The LC/MS result has to be sent to a lab and the result is not available for days to weeks after the visit is over. This is the screen that showed alcohol metabolites and again was not available at the time of my visit. All compliance markers were consistent at the time of the visit. I only saw Patient I one time. She continued care with a different independently licensed provider employed by Seattle Pain Centers and not supervised by me. Since I only saw her once, and all compliance markers were consistent, it is denied that there was any evidence available to me of a failed urine drug screen. It is also alleged that medications were not withheld. Oxycodone was withheld and this is clearly outlined in the note. A safer medication with less addiction potential and similar analgesic properties was prescribed instead as a safety measure despite all compliance markers being consistent at the time of the visit. Regarding Patients A – H, while under my care, the medical records demonstrate that NONE of these patients had failed urine drug screens, NONE had inappropriate requests for early refills based on overuse, NONE had inconsistent pill counts, and NONE had admitted misuse or abuse. Although the term “repeatedly” is used in this paragraph, there is not a single instance of any of these occurrences involving patients A - I while under my care and thus no cause to “enforce treatment compliance.” The remainder of this paragraph is adamantly denied. 1.8 This paragraph alleges that I failed to complete periodic reviews. This paragraph refers to periodic reviews of chronic non-cancer patients and gives 2 examples where opioids were prescribed for prolonged intervals without review. Specifically, it is alleged that Patient F was discharged and that I prescribed her morphine. She was never discharged from a clinic and she was never prescribed morphine by me. A cursory review of the records or the PMP report confirms this. In terms of a periodic review for chronic non-cancer patients, this was done in depth with a full panel of compliance marker testing, PMP review, functional assessment and monitoring for adverse reactions. This was done every 2 - 3 months depending on the period and this interval is far more frequent than the recommendations made in the Washington Administrative Code and thus exceeds the standard of care. The dates listed below reference office visits for Patients F and C during the time period where it is alleged that I did not see them for periodic review. Each patient’s records shows a 100% history of medical compliance and their functional gains are clearly outlined at each visit. Allegation 1.8 is clearly refuted by the medical record. Patient F was seen on by me on 5/27/15, 6/23/15, 9/11/15, 10/1/15, 12/15/15, and 1/12/16 and then again on 4/1/16, 5/2/16, 7/22/16, and 8/19/16 by another provider. Thereafter, she was referred out to another pain clinic as I converted my practice to a non-opioid prescribing pain management practice. Patient C was seen by me on 2/10/15, 5/12/15, 6/25/15, 7/7/15, 8/4/15, 10/29/15, 1/2116, 4/12/16, 6/30/16, 8/24/16, 10/28/16, 12/4/16 and 2/1/16. He was then referred out to another pain clinic specializing in medication management as I transitioned my practice to become opioid free. The allegations in 1.8 are denied. The DOH has made these charges without review of these records and without even requesting the current records to confirm the accuracy of the allegations. 1.9 & 1.10 These paragraphs allege that I failed to execute an “opiate exit strategy” and that I was involved in Patient D’s interventional pain management but continued to prescribe him oxycodone without improvement. Regarding an “exit strategy,” I was unable to find any reference to this term in the guidelines provided in WAC 246 853 663, 664, 665 and 667 so it is unclear where this reference comes from and why this term is included in these charges. In other resources, an opioid exit strategy is employed if the patient is not sufficiently responsive to opioids or if there is diversion addiction or abuse identified. It is clearly documented in the charts for Patients A-H that they were adequately responding to opioids and none of them exhibited any diversion, addiction or abuse under my care. As outlined earlier, Patient I was not under my care beyond one visit and at that time she was responding to opioids after failing other more conservative options and there was no evidence at the visit of diversion, addiction or abuse. Patient D has a diagnosed spinal cord injury pain. This is one of the worst pain syndromes known to man and requires unusually comprehensive pain management techniques. He also had severe post-surgical spine pain from upwards of 11 surgeries, many of which failed and required even more extensive surgeries just to stabilize the spine. Patient D has been on opioids since being injured in 2002. He had also tried all other indicated forms of pain management. One of his spine surgeons stated that, due to the nature and severity of his injuries, “I do not think he will ever be completely rid of his narcotic medication”. Patient D’s condition is also described in the same paragraph as “permanently irreversible.” He was unquestionably responding to opioid therapy even at drastically decreased doses while in my care as evidenced by the fact that he was ambulating independently with a single Lofstrand crutch. Once the therapy lost efficacy, he required a wheel chair. Walking versus using a wheel chair is one of the most obvious measures of functional response to a medication. When I first saw Patient D in 2013, he was on 240 oral MED and 21,468 MED through a pain pump. Intrathecal opioids are 300 times more potent than oral opioids. I identified this as being ineffective and immediately tapered him off of the opioids through the pain pump. This represents greater than a 90% decrease in total opioid exposure. He was also on dangerous levels of clonidine through the pump and this was stopped as well for safety. I also took him off long acting systemic oral opioids. Multiple other non-opioid intrathecal medications were then tried including Prialt and bupivacaine. Additionally, further injections and a spinal cord stimulator were applied. Throughout the process of trying every safe and appropriate therapy for this young man, he remained on systemic opioid medications just as he had been on for many years. These were managed with extremely close monitoring and he never exhibited any measure of diversion, addiction or abuse. In fact, I sent him for a psychological evaluation and the testing revealed “no problems regarding alcohol”, and “no problems with other drugs”. It was also well documented repeatedly in the hand typed portion of my notes that the medications were providing functional benefit that was allowing him the greatest quality of life possible. During this process of trialing everything that might be of benefit and after already decreasing the total opioid exposure by greater than 90%, I state a follows in his medical record: “As always, the goal is to be able to make functional gains and decrease systemic medications as able” (5/23/14), “the overall goal remains to achieve meaningful analgesia with Prialt and taper opioids. If Prialt fails, we will pursue other non-opioid intrathecal options” (2/14/14), “continue medical therapy for now. Ideally, we can find a solution with the pump or possibly Spine surgery to decrease the opioids. If this is not possible we will have to taper opioids for a holiday”. (3/4/14), “Prialt has failed at the maximum dose. He continues to have meaningful functional analgesia with his systemic medications…The next step is to titrate intrathecal bupivacaine to efficacy or intolerance without an opioid and within the guidelines. …PMP consistent…UDS consistent…Continue medical therapy for now as we pursue an intrathecal solution and plan to taper systemic opioids” (3/28/14), “No analgesia or side effect with IT therapy. Medical therapy is stable and promotes function at doses > 120 MED…Continue medical therapy with consent. PMP and UDS consistent. We have failed to make progress with extensive manipulation of the pump. We have discussed SCS trial in the past and he is ready to proceed” (4/25/14), The pump and SCS are both functioning to treat axial and neuropathic pain. In combination with systemic medications he maintains functional analgesia and quality of life…He has no side effects from the pump or systemic medications and wishes to continue both…All compliance markers consistent” (11/26/14), in reference to if systemic opioids ever lose efficacy, “As always, the offer to taper all systemic opioid stands and he will let me know when he is ready to purse this” (11/26/14). This marked the last visit I had with Patient D. Sometime after I voluntarily left Seattle Pain Centers, Patient D experienced a very drastic functional decline. When under my care, this young man was ambulating independently with the use of a single Lofstrand crutch and was exercising and functioning optimally. By 3/3/15, almost 6 months after I last treated him, he had deteriorated to the point where he needed a wheel chair evidenced by the prescription for a wheel chair in the medical records. At that point, an exit strategy would have been appropriate. However, Patient D was not under my care during this time. Also, during the course of this patient’s care with me, I diagnosed him with sleep apnea. At the time of this diagnosis, I stated “To review, since I have been seeing him, we have drastically reduced the total opioid load by taking it out of the pump” (2/14/14).” I went on to diagnose him with a neuroendocrine imbalance related to “his history of division 1 football” (chronic traumatic encephalopathy), and “history of a pituitary lesion and history of very low testosterone.” I further state as follows: “All these factors predispose him to hormone imbalances and he is symptomatic in terms of depression and poor sleep despite adequate CPAP use. No SI. I asked him to seek comprehensive evaluation of the hormones and he agrees.” Extensive local and national resources were provided for the treatment of neuroendocrine dysfunction at the time. It is also alleged that Patient D did not experience improvement with medications. I quote below excerpts from his medical record with dates describing the improvements associated with his medical therapy. Pay particular attention to the ability to walk in this patient with a spinal cord injury: “….. Improves his walking ability 10/21/13, improves his walking ability 10/14/13, He achieves functional gains with the stable combination of IT and PO opioids 9/9/13, improves his walking ability 9/9/13, Improves his ability to function adequately overall 6/12/13.” The pump and SCS are both functioning to treat axial and neuropathic pain. In combination with systemic medications he maintains functional analgesia and quality of life. He has no side effects from the pump or systemic medications and wishes to continue both 11/26/14. In the interval, he had a successful SCS implant. He continues to have functional analgesia with his IT and systemic medical regiment without side effect and wishes to continue this therapy. Functional gains noted 9/9/14, Continue systemic medical therapy as functional gains are noted 7/22/14, improves his walking ability 7/11/14, improves his walking ability, improves his ability to work or perform household chores 6/20/14, Improves his ability to function adequately overall, improve his mood, improves his walking ability, improves his ability to work or perform household chores improves his ability to interact socially with other people, improves his ability to sleep, improves his enjoyment of life 6/12/14, He also continues demonstrable and documented functional gains with systemic doses of opioids 5/23/14, Improves his ability to function adequately overall, improves his walking ability, improves his enjoyment of life 5/1/14, (Patient D) rates his functional activity level 8/10 WITH his medications, Without his medications he rates his activity level 4/10 on the same scale 3/31/14, improves his walking ability, improves his ability to work or perform household chores, improves his ability to interact socially with other people 3/28/14, He continues to have meaningful functional analgesia with his systemic medications 3/28/14, Improves his ability to function adequately overall 1/28/14.” At no time did Patient D have an adverse outcome related to my care, and there has been no patient complaint from Patient D related to my care. In fact, Patient D has written a letter of appreciation for the treatment I provided, which is included in Exhibit A. There wasn't even a mild side effect related to medications prescribed in Patient D, he had extremely close monitoring, there was no evidence of diversion or addiction or abuse, and there was no risk to the community related to my care of Patient D. An exit strategy need not apply while there is such a clear, adequate and functional response to opioids without any evidence for diversion, addiction, or abuse. Regarding an “exit strategy” for the remainder of the patients named, find below the evidence that they in fact were responding adequately and positively with clear functional gains to opioids and that there was no evidence of diversion, addiction or abuse and therefore no need for an exit strategy: Patient A had severe spine and nerve pain after many surgeries and intolerable spasm related to nerve damage. High dose intrathecal opioids were added to high dose oral opioids by physicians at UW in the late 2000’s. She had been on MED doses as high as 1,176 oral and 11,828 intrathecal concomitantly in the past. Her MED lowered from 195 down to 91. Medical technologies, including spinal cord stimulation and radio frequency lesioning, were employed and the patient went from being disabled to back to work with the combination of appropriately applied medical technology and careful use of medical analgesics. At no time did Patient A have an adverse outcome related to my care. There has been no complaint from Patient A related to my care. There wasn't even a mild side effect related to medications prescribed in Patient A, with extremely close monitoring and no evidence of diversion or addiction or abuse. There was no risk to the community related to my care of Patient A. Patient B suffered from severe organic kidney pain due to a genetic metabolic disorder that causes kidney stones to be formed at an accelerated rate. She also had a diagnosis of severe scoliosis with a 76 degree curve in her spine and thoracic myelopathy, a form of painful spinal cord damage that also causes painful muscle spasticity. In the past she had been on MED doses as high as 1,536 oral and also has a pain pump. Her MED oral dose for the duration of the time I saw her was 120 with functional gain and no side effect, which did not change. When I first saw her, I decreased her total opioid exposure and risk significantly by decreasing the pump dose by 10% and later also removing a dangerous medication from the pump again for safety reasons. While also under my care, we did a hip injection and a surgical referral. There was no escalation of her systemic medication. At no time did Patient B have an adverse outcome related to my care. There has been no patient complaint from Patient B related to my care. There wasn't even a mild side effect related to medications prescribed in Patient B, with extremely close monitoring. In addition, there was no evidence of diversion or addiction or abuse and there was no risk to the community related to my care of Patient B. According to the PMP, she since has been titrated up in dose and is currently at twice the doses I had her on. Patient C had severe autoimmune mediated abdominal pain and his MED is 40. He had been stable on this dose with demonstrable functional gains and is able to maintain full time employment with this very conservative dose of medication after failing all other indicated nonopioid treatments. Other care I have provided him includes cervical epidural steroid injections that resolved cervical radiculopathy, a peripheral injection that resolved painful tendonitis, topical analgesics and other conservative care. At no time did Patient C have an adverse outcome related to my care. There has been no patient complaint from Patient C related to my care. There wasn't even a mild side effect related to medications prescribed in Patient C, with extremely close monitoring and no evidence of diversion or addiction or abuse. Finally, there was no risk to the community related to my care of Patient C. In February of 2017, I referred him to a center specializing in medication management as I eliminated opioid prescribing form my practice. Patient E was described in detail earlier. I recommended treating her pain with surgery. I recommended tapering opioids which she has successfully done. I recently implanted a spinal cord stimulator in her spine to facilitate further tapering of opioids and functional pain relief. Her current medical management is not under my care. At no time did Patient E have an adverse outcome related to my care. There has been no patient complaint from Patient E related to my care. There wasn't even a mild side effect related to medications prescribed in Patient E, with extremely close monitoring and no evidence of diversion or addiction or abuse. Finally, there was no risk to the community related to my care of Patient E. I did not see Patient F while I worked at Seattle Pain Centers. I assumed her care at the request of her PCP after I left Seattle Pain Centers. She has lumbar spinal stenosis, lumbar radiculopathy/radiculitis, lumbar discogenic pain, and lumbar spondylitic pain. She has tried “every form of conservative, non-opioid medical and interventional treatment available to her without success.” The highest dose I ever prescribed to her was MED 90. She had very significant documented functional gains and no side effects. At no time did Patient F have an adverse outcome related to my care. There has been no patient complaint from Patient F related to my care. There wasn't even a mild side effect related to medications prescribed in Patient F, with extremely close monitoring, and no evidence of diversion or addiction or abuse. Finally, there was no risk to the community related to my care of Patient F. Patient G is a woman with chronic abdominal pain related to multiple surgeries, pain from a retroperitoneal tumor that required a massive combined surgery with Gynecology and Urology that became life threatening for the patient, and discogenic radicular spine pain. Her MED has never been above 105. Despite having a lifetime history of medical compliance and clear functional gains with medical therapy, I began to taper opioids in this patient in November of 2016 as I changed my practice. Her opioid taper continues today. She has failed all indicated forms of non-opioid medical and conservative and injection therapy. At no time did Patient G have an adverse outcome related to my care. There has been no patient complaint from Patient G related to my care. There wasn't even a mild side effect related to medications prescribed in Patient G, with extremely close monitoring, and no evidence of diversion or addiction or abuse. Finally, there was no risk to the community related to my care of Patient G. Patient H had severe spine discogenic pain and had tried physical therapy and other conservative measures, epidural steroid injection, facet joint injection, radio frequency lesioning, a spinal cord stimulator trial and implant with subsequent explant as well as all indicated classes of non-opioid medications. After failing medical therapy for migraine, I treated her successfully with Botox injections. She too has a lifetime history of medical compliance. Despite being stable for many years with demonstrable functional gains on MED of 90 after I took her off of sedating long acting opioids started by a different provider, I referred her out of my practice to a center specializing in medication management as my practice became opioid free. At no time did Patient H have an adverse outcome related to my care. There has been no patient complaint from Patient H related to my care. There wasn't even a mild side effect related to medications prescribed in Patient H, with extremely close monitoring, and no evidence of diversion or addiction or abuse. Finally, there was no risk to the community related to my care of Patient H. I only saw Patient I once. At that time, compliance markers were consistent and opioids were indicated. At no time did Patient I have an adverse outcome related to my care. There has been no patient complaint from Patient I related to my care. There wasn't even a mild side effect related to medications prescribed in Patient. At the time of my one visit with her, there was no evidence of diversion or addiction or abuse, and there was no risk to the community related to my care. Any “exit strategy" would have been up to the provider caring for her during subsequent visits and again would involve an insufficient response to opioids or a compliance issue. Therefore, allegations 1.9 and 1.10 are denied. C. CONCLUSION: Given all of the above information, my leadership both locally and nationally to combat against the opioid epidemic, the fact that I am the only pain specialist in my region not participating in chronic opioid prescribing, and direct evidence disproving all of the negative claims submitted against me in the medical records for Patients A-I, I absolutely deny all negative claims made against me. I did nothing wrong. There was no patient complaint, there was no adverse outcome, there wasn't even so much as a harmless side effect, and there was certainly no risk to the community. I am and will continue making a concerted effort to transition the opioid epidemic into other forms of effective and safe modalities for treating patients who unfortunately require pain management services. I am prepared to refute all of the allegations being made against me in this matter. The one and only action that makes sense at this point is for the department to drop these charges against me and continue to partner with me and others like me in the charge to eliminate the opioid epidemic from our state.