Garland V. Greene, M.D., DAB CR6072 (2022)

DECISION

I affirm the determination of the Centers for Medicare & Medicaid Services (CMS) to revoke the Medicare enrollment and billing privileges of Garland V. Greene, M.D., (Dr. Greene or Petitioner) under 42 C.F.R. § 424.535(a)(14)(i) because he engaged in a pattern or practice of prescribing drugs under Medicare Part D in a manner that was abusive or represented a threat to the health and safety of Medicare beneficiaries, or both.

I.  Background and Procedural History

Dr. Greene, a physician, was enrolled in the Medicare program as a supplier.  CMS Ex. 39.  The National Benefit Integrity Medicare Drug Integrity Contractor (MEDIC) identified Petitioner as prescribing excessive doses of controlled substances for seven beneficiaries.  The seven beneficiaries were associated with Prescription Drug Event (PDE) records “with excessive doses opioids and/or potentially inappropriate combinations of controlled substances.”  CMS Ex. 7 at 1.

MEDIC inquired into the matter, obtaining medical records for the beneficiaries, which the MEDIC Medical Director and a MEDIC pharmacist reviewed.  In a July 18, 2018 Medical Review Summary, the clinical review of the medical records showed that “[a]ll

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seven beneficiaries received excessive doses of opioid analgesic controlled substances.”  CMS Ex. 7 at 1.  In addition, the clinical review indicated that the medical records lacked the following:  detailed plans of care, specific functional goals, or functional responses to the treatment; consistent responses when five of the beneficiaries had inappropriate findings on their drug screens; and documented sustained improvement in either pain scores or functionality.  CMS Ex. 7 at 2.  The clinical review concluded that, despite the lack of improvement in pain and functional ability, Petitioner continued opioid therapy and the record did not support a conclusion that Petitioner was adhering to pain management guidelines in effect at that time.  CMS Ex. 7 at 2.

On September 14, 2018, MEDIC also conducted an overdose analysis regarding three of Petitioner’s patients.  CMS Ex. 7 at 4-6.  The analysis established that “three beneficiaries received excessive doses of opioid analgesics from only [Petitioner] within 30 days prior to an overdose as identified in Medicare Parts A, B, or C claims data.”  CMS Ex. 7 at 4.

In a third document, MEDIC concluded the following as to the specific concerns related to quantities of opioids that Petitioner prescribed to his patients:

The [Centers for Disease Control and Prevention (CDC)] review found that although there is not a single dosage threshold below which overdose risk is eliminated, holding [morphine equivalent dose (MED)] less than 50mg/day would likely reduce risk among a large proportion of patients who would experience fatal overdose at higher prescribed dosages.  The CDC found that, in general, increasing MEDs to greater than or equal to 50mg/day increases overdose risk without necessarily adding benefits for pain control or function and that clinicians should carefully reassess evidence of individual benefits and risks when considering increasing opioid MEDs greater than or equal to 50mg/day.  Most experts also agree that opioid dosages should not be increased to MED greater than or equal to 90mg/day without careful justification based on diagnosis and on individualized assessment of benefits and risks.  In the studies reviewed, experts noted that daily MEDs close to or greater than 100mg/day are associated with significant risks.

The pharmacist review and medical record review conducted by the NBI MEDIC established a pattern of [Petitioner] authorizing excessive doses of opioid analgesics.  The medical record review showed all seven of the beneficiaries reviewed received a MED greater than 120mg/day without

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sufficient justification as to why these excessive doses were necessary.  Further, all seven beneficiaries had MEDs greater than 200mg/day, five had a MED greater than 500mg/day, and one had a MED greater than 1,000mg/day.  In addition, five of the seven beneficiaries received benzodiazepines in conjunction with opioids.

In March of 2016, the CDC’s opioid treatment guidelines noted concurrent prescribing of opioid analgesics and benzodiazepines as a high-risk practice that increases the risk of fatal overdoses.  This increased risk prompted the Food and Drug Administration (FDA) to require “black box warning” with this information on all prescription opioid analgesics, opioid-containing cough products, and benzodiazepines.

CMS Ex. 7 at 7-8.

Relevant to this case, the MEDIC investigation included the following nine patients, identified by their initials for privacy purposes:  P.H., L.R., T.G., W.F., T.M., S.R., R.N., B.S., and L.P.  June 30, 2020 Joint Stipulation ¶ 5.

In a December 14, 2018 initial determination, a CMS contractor revoked Dr. Greene’s Medicare enrollment and billing privileges, effective January 13, 2019, based on improper prescribing practices under 42 C.F.R. § 424.535(a)(14)(i).  CMS Ex. 2.  The initial determination stated:

42 CFR §424.535(a)(14) - Improper Prescribing Authority

* * * * *

[Petitioner] prescribed excessive dosages of opioids that are linked to patients’ overdoses, in violation of 42 CFR 424.535(a)(14)(i)(C).  Beneficiary P.H. had an overdose event on August 12, 2016.  According to medical records review, one day prior to the overdose, [Petitioner] prescribed beneficiary P.H. a 30 day supply of oxycodone and hydromorphone at a Morphine Equivalent Dosage (MED) of 154 mg/day.  Beneficiary P.H. filled these prescriptions on August 11, 2016.  According to pharmacist review conducted on September 14, 2018, this instance of overdose can be linked to [Petitioner’s] excessive prescribing.

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Beneficiary L.R. had an overdose event on May 23, 2017.  According to medical records review, between five and eight days prior to the overdose, [Petitioner] prescribed beneficiary L.R. a 30 day supply of morphine sulphate ER and hydromorphone at a Morphine Equivalent Dosage (MED) of 372 mg/day.  Beneficiary L.R. filled these prescriptions on May 15, 2017 and May 18, 2017.  According to pharmacist review conducted on September 14, 2018, this instance of overdose can be linked to [Petitioner’s] excessive prescribing.

Additionally, pharmacist review conducted on September 14, 2018, revealed [Petitioner] was prescribing drugs at a MED greater than 120mg/day without sufficient justification as to why these excessive doses were necessary.  Seven (7) beneficiaries were reviewed with MEDs greater than 120mg/day, with the highest MED during the review period being 1,080mg/day.  This prescribing pattern placed beneficiaries at a high risk for overdosing in violation of 42 CFR 424.535(a)(14)(i)(H).

CMS Ex. 2 at 1.  The CMS contractor barred Dr. Greene from re‑enrollment in the Medicare program for three years.  CMS Ex. 2 at 1-2; 42 C.F.R. § 424.535(c).

In a February 4, 2019 request for reconsideration, Dr. Greene argued that he treats each patient individually and that there is no single MED amount that can be considered excessive or inappropriate.  CMS Ex. 1.  Dr. Greene also provided specific information related to beneficiaries P.H. and L.R., as well as the seven beneficiaries discussed in the initial determination.  CMS Ex. 1 at 4-5.  Dr. Greene concluded with:

From what I have written here and from the summaries that I have provided, I believe that you will find that we do not prescribe opioid medication irresponsibly, excessively or abusively.  In fact, I believe you will find, if the records are reviewed, that we take care and go to great lengths to see that our patients are adequately cared for and monitored well to prevent misuse, abuse, diversion and unintentional adverse outcomes.

CMS Ex. 1 at 6.  CMS Exhibits 9 through 15 are medical records for beneficiaries T.G., W.F., T.M., S.R., R.N., B.S., and L.P., and “are the complete responses that Dr. Greene provided [to CMS] to support his prescriptions for the listed Medicare beneficiaries . . . .”  June 30, 2020 Joint Stipulation ¶ 9.

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In a May 16, 2019 reconsidered determination, a CMS hearing officer upheld the revocation under 42 C.F.R. § 424.535(a)(14)(i).  The hearing officer concluded that the record supported four of the eight factors listed under 42 C.F.R. § 424.535(a)(14)(i) and, therefore, CMS properly revoked Petitioner under that regulation.  CMS Ex. 20.

The first factor the hearing officer considered was whether Petitioner prescribed controlled substances in excessive dosages that are linked to patient overdoses.  42 C.F.R. § 424.535(a)(14)(i)(C).  The hearing officer found that Petitioner prescribed excessive doses of controlled substances to two beneficiaries who experienced overdose events.  CMS Ex. 20 at 5-6.

The hearing officer then considered the number, type, and reasons for disciplinary actions taken against Petitioner by the licensing body or medical board for the state or states in which Petitioner practices.  42 C.F.R. § 424.535(a)(14)(i)(D).  The hearing officer also considered whether Petitioner had any history of final adverse actions as defined in the regulations to include license suspensions or revocations, or suspension by an accreditation organization, or exclusion or debarment from participating in a federal or state health care program.  42 C.F.R. § 424.535(a)(14)(i)(E).

The hearing officer found that Petitioner had a history of disciplinary actions taken against him, along with a history of final adverse actions as defined under 42 C.F.R. § 424.502.  Specifically:

• In 2004 the Virginia Board of Medicine suspended Petitioner’s license for improper monitoring and prescribing of opioids. As part of the suspension, Petitioner agreed to surrender his Drug Enforcement Administration (DEA) certificate and DEA 22 Schedule II order forms.  In 2009, the Virginia Board of Medicine denied Petitioner’s request to reinstate his medical license.  In 2012, the Virginia Board of Medicine reinstated Petitioner’s license with restrictions.  It was not until January 16, 2014, that the Virginia Board of Medicine terminated the restrictions placed on Petitioner’s medical license.
• In 2005 the North Carolina Medical Board suspended Petitioner’s license based on the Virginia Board of Medicine’s suspension. Petitioner’s North Carolina license has not been reinstated.
• Beginning January 19, 2005, and lasting through August 24, 2014, Petitioner was excluded from participating in Medicare, Medicaid, or any federal health care programs by the U.S. Department of Health and Human Services, Office of Inspector General.

CMS Ex. 20 at 6-7.

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Finally, the CMS hearing officer considered any other relevant information provided to CMS.  See 42 C.F.R. § 424.535(a)(14)(i)(H).  Specifically, Petitioner’s prescribing practice was higher than that of his peers for opioids, Schedule II (CS II) controlled substances, and Schedule III-V (CS III-V) controlled substances.  A peer comparison analysis for January 1, 2015 through May 31, 2018, ranked Petitioner 19th (out of 5,232 prescribers included in the comparison) for prescribing opioids, 16th for prescribing CS II drugs, and 101st for prescribing CS III-V drugs.  CMS Ex. 20 at 7.  The hearing officer also noted that the MEDIC review “identifies beneficiaries with MEDs ranging from 210 mg/day to 1,080 mg/day[,]” when CMS utilizes an MED of 120mg per day.  CMS Ex. 20 at 7.  Petitioner consistently used non-specific pain-related diagnoses, excessive opioid doses and/or potentially inappropriate combinations of controlled substances.  “There was no documented sustained improvement in either pain scores or level of function for any of the beneficiaries; however, despite the lack of improvement in pain and functional ability, chronic opiate therapy was continued by [Petitioner].”  CMS Ex. 20 at 8.

On July 17, 2019, Petitioner electronically filed a request for hearing before an administrative law judge (ALJ).  In his request for hearing, Petitioner indicated his intent to address and contest several findings set forth in the reconsidered determination.

On July 18, 2019, the Civil Remedies Division acknowledged the hearing request and issued my Standing Prehearing Order (Order) that established a prehearing submission schedule.  After receiving extensions, on November 15, 2019, CMS filed its prehearing brief along with 66 proposed exhibits.  Included with those proposed exhibits were written direct testimony from the following three witnesses:  Calvin H. Hirsch, M.D., F.A.C.P. (CMS Ex. 51), Edward L. Humpert, M.D., M.S. (CMS Ex. 52), and Johanna L. Sullivan, Pharm.D. (CMS Ex. 54).

After receiving four extensions, on April 6, 2020, Petitioner filed his brief and one exhibit (P. Ex. 1).  Petitioner objected to a number of CMS’s proposed exhibits.  Petitioner had no witnesses but requested to cross-examine CMS’s three witnesses.

On April 21, 2020, CMS filed a reply brief in response to Petitioner’s objections, along with four supporting exhibits, CMS Exs. A-D.  CMS did not object to Petitioner’s proposed exhibit.

On April 28, 2020, I held a pre-hearing conference to discuss, among other things, the evidence submitted and evidentiary objections.  In a May 14, 2020 Order Following Prehearing Conference and Notice of Hearing, I notified the parties that I would hold a hearing on August 13, 2020, and summarized the results of the prehearing conference.  I also stated that, during the prehearing conference, I admitted Petitioner Exhibit 1, CMS Exhibits 1 through 66, and CMS Exhibit A into the record, although I only provisionally admitted the written direct testimony from CMS’s witnesses (CMS Exs. 51, 52, 54, and A) until the witnesses appeared for cross-examination at the hearing.  In the order, I also

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provided explanations why I overruled Petitioner’s objections to CMS Exhibits 2, 7, 8, 16, 17, 18, and 21, noting in several instances that CMS would provide Petitioner with documentation that Petitioner thought was missing from some of the exhibits and that two of CMS’s witnesses could be cross-examined as to these documents.  Finally, I ordered the parties to confer as to whether they could stipulate to facts in this case.

On August 13, 2020, I held a hearing in this case at which Petitioner cross-examined Dr. Sullivan and Dr. Humpert.  I held a supplemental hearing on September 30, 2020, at which Petitioner cross-examined Dr. Hirsch.  At the conclusion of the hearing, I directed counsel to provide in their post-hearing briefs all arguments that they wanted me to address in my decision.  November 5, 2020 Notice of Receipt of Transcript and Post-Hearing Briefing Schedule at 1.

After a transcript of the hearing (Tr.) was produced, CMS and Petitioner filed post-hearing briefs (CMS Br., P. Br.) and CMS filed a reply brief (CMS Reply).

II.  Issue

Whether CMS had a legitimate basis for revoking Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(14)(i).

III.  Jurisdiction

I have jurisdiction to decide this case.  42 C.F.R. §§ 498.1(g), 498.3(b)(17), 498.5(l)(2); see also 42 U.S.C. § 1395cc(j)(8).

IV.  Expert Witnesses

As stated above, CMS presented three expert witnesses in this case.  At the hearing, Petitioner objected to the qualification of Dr. Humpert and Dr. Hirsch as expert witnesses.  Tr. 133, 218.  Specifically, Petitioner objected to the fact that both witnesses were not pain-management physicians and never worked in a pain management clinic.  Tr. 135, 137.  I overruled Petitioner’s objection, noting that Drs. Humpert and Hirsch had the education, background, and experience to qualified them as expert witnesses.  Tr. 137, 218-220.

In post-hearing briefing, Petitioner argues that I should “give very little to no weight to all or part of [Drs. Humpert’s and Hisch’s] testimony under the facts of this case.”  P. Br. at 5-9.

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Petitioner argues that Dr. Humpert’s testimony should be given no weight because he has limited experience with opioids, that experience was while he actively practiced surgery from 1972 to 1994, and Dr. Humpert has not seen patients in the last 24 years.  P. Br. at 7.  Petitioner also said Dr. Humpert was argumentative when he testified.  P. Br. at 8.

Dr. Humpert has a Doctor of Medicine and a Master of Science in respiratory physiology,  is a licensed physician, is Board-certified by the American Board of Surgery, served for years in the 1960’s and 1970’s as a surgeon and a chief of surgery at a hospital, served as a Chief of Surgical Services in the United States Air Force Medical Corps in the 1980’s, and served in the U.S. Air Force Medical Corps Reserve and the U.S. Army Medical Corps Reserve from 1987 through 1997, while again in private practice.  CMS Ex. 52 ¶¶ 1, 6-8; CMS Ex. 53.  From the mid-1990’s until present, Dr. Humpert has worked at a variety of medical director positions, a number of them with Medicare Administrative Contractors.  CMS Ex. 53 at 1.  The position he has held since 2018 and while testifying in this case was as a medical director with Qlarant Integrity Solutions, LLC (Qlarant) /MEDIC, which was assigned a contract as the MEDIC that investigated Petitioner.  CMS Ex. 52 ¶ 3; CMS Ex. 53 at 1.

Dr. Humpert testified that he had a high-level of knowledge about opioids and opioid abuse despite not being a pain management specialist.  Dr. Humpert testified that, since March 2018, he self-studied pain management and opioids because two of Qlarant’s large contracts deal with those subjects.  Tr. at 131-132.  He also testified that from 1972 to 1994, he engaged in surgery and would treat patients following surgery with small, medium, and large amounts of MME.  Tr. at 138-139.  He stated:  “I have decades of experience as a general surgery practitioner, and I am very familiar with the use and prescriptions of opioids, analgesics, and other medications and procedures to relieve pain, especially when treating post-operative pain after surgery.”  CMS Ex. 52 ¶ 1.  Dr. Humpert may not be a pain management specialist, but his years of training and experience as a physician, along with his own study, certainly provide a basis for me to consider his opinion about Petitioner’s prescribing practices.

As to Petitioner’s claim that I should disregard Dr. Humpert based on his interactions with Petitioner’s counsel on cross-examination, it is important to note that Petitioner’s counsel was also aggressive toward him at times.  An example is when Dr. Humpert answered a question and referenced his master’s degree in respiratory physiology because he had just testified about a drug combination that could cause an individual to stop breathing.  Petitioner’s counsel sarcastically retorted:  “I know, back in 1960-something.  I recall.”  Tr. 167.  It is an unfortunate aspect of the adversarial system that counsel and witnesses agitate each other; however, the circumstances during the hearing in this case provide no basis to disregard Dr. Humpert’s testimony.

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Regarding Dr. Hirsch, Petitioner argues that Dr. Hirsch’s specialty in geriatrics is not relevant to this case because the patients involved in this matter were not elderly and Dr. Hirsch did not testify definitively about various matters.  P. Br. at 5-6.

Dr. Hirsch holds a Doctor of Medicine, has been employed with the University of California at Davis since 1989 and currently is full professor at the School of Medicine, and is Board Certified in Geriatrics and Internal Medicine.  CMS Ex. 50 at 1; CMS Ex. 51 at 1; Tr. 211.  Dr. Hirsch published an article/book chapters in 2019 and 2020 on pain management.  Tr. 212-213; CMS Exs. 57-58.  When asked when he developed a specialty in issues of opioids and pain management, Dr. Hirsch testified:  “I'm an academic geriatrician . . . and as such, because pain has a prevalence of at least 50 percent of people over the age of 65, it’s important for me to understand pain to teach pain management to our house staff in Internal Medicine.”  Tr. 214.  Dr. Hirsch testified that his knowledge of geriatric pain management applies to younger people because a lot of the same principles apply to both groups.  Tr. 215.  Dr. Hirsch stated that a difference would be that as people age, the speed at which they metabolize drugs and their potential level of action may change; however, Dr. Hirsch noted that none of the patients reviewed for this case were young either.  Tr. 216.  Dr. Hirsch was paid as a private consultant to testify in this case.  Tr. 216-217.  Based on Dr. Hirsch’s education and experience, I see no reason to disregard his testimony.

Regarding Dr. Sullivan, Petitioner argues that Dr. Sullivan is “a doctor of pharmacy (not a medical doctor),” “[h]er entire salary was paid through CMS dollars,” and she lacked the “education, training and experience to render opinions” on how any physician should practice medicine.  P. Br. at 8-9; see Tr. 11-12; CMS Ex. 55.

While Dr. Sullivan is not qualified to testify how a physician should provide medical care, she is qualified to render an opinion on health and safety concerns related to the prescription of controlled substances.  Dr. Sullivan has a Doctor of Pharmacy, is licensed as a pharmacist in two states, and has 24 years of varied experience as a pharmacist.  CMS Ex. 54 ¶¶ 1-9; CMS Ex. 55.  Although, as the chief pharmacist for MEDIC she is employed by MEDIC, she testified that she receives a set salary and did not receive additional compensation for testifying in this case.  Tr. at 11-12.  Dr. Sullivan has significant experience, having served as a hospital pharmacy director and as a pharmacist at long-term care facilities and a hospice, as well as a pharmacy manager involved with opioid management programs for the state of Florida.  Tr. at 15.  I will not disregard her testimony in this case.

In general, my review of the record shows that the expert witnesses testified consistently with the record and, to a great extent, with each other.  Petitioner’s cross-examination of the witnesses did not provide a basis for me to question their knowledge or the usefulness of their testimony.  While this does not mean I rely on all of their testimony, I do

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generally credit their testimony.  Below, I cite and quote from the testimony for each of these witnesses, and this is the testimony to which I afford the most weight.

It is significant that Petitioner neither provided any expert witness testimony or, as a pain management specialist, testimony of his own.  In the absence of such contrary testimony to call into question the testimony of CMS’s experts, I must consider that testimony when deciding this case because I am to render my decision based on the evidence in the record.

V.  Findings of Fact, Conclusions of Law, and Analysis

The Social Security Act (Act) authorizes the Secretary of Health and Human Services (Secretary) to establish regulations for enrolling providers and suppliers in the Medicare program.  42 U.S.C. § 1395cc(j)(1)(A).  Providers and suppliers must enroll in the Medicare program and receive a billing number to obtain payment for services rendered to Medicare beneficiaries.  42 C.F.R. § 424.505.  For Medicare purposes, a physician is considered a supplier.  42 U.S.C. § 1395x(d).

The Secretary delegated to CMS the authority to revoke the enrollment and billing privileges of providers and suppliers.  42 C.F.R. § 424.535.  CMS or a CMS contractor may revoke a provider or supplier’s Medicare enrollment and billing privileges for any of the reasons listed in 42 C.F.R. § 424.535(a).  42 C.F.R. §§ 405.800(b)(1), 424.535(a).  If CMS revokes a provider or supplier’s Medicare enrollment and billing privileges, the revocation becomes effective 30 days after CMS or one of its contractors mails the revocation notice to the supplier, subject to exceptions not applicable in this case.  42 C.F.R. §§ 405.800(b)(2), 424.535(g).  For purposes of the present case, after CMS revokes a provider or supplier’s enrollment and billing privileges, CMS bars the supplier from reenrolling in the Medicare program for a minimum of one year, but not more than three years.  42 C.F.R. § 424.535(c).

Several CMS regulatory enforcement actions, including the revocation of Medicare enrollment, are adjudicated under the procedural regulations in 42 C.F.R. pt. 498 (Part 498 regulations).  See 42 C.F.R. §§ 498.3, 498.5.  More than 20 years ago, the Departmental Appeals Board (DAB) interpreted the Part 498 regulations to include evidentiary burden shifting.  Specifically, if a Medicare provider challenges the existence of a regulatory deficiency, CMS must make a prima facie case that the provider failed to substantially comply with federal requirements, and, if this occurs, the provider must then prove substantial compliance by a preponderance of the evidence.  Hillman Rehab. Ctr., DAB No. 1611 (1997); see Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001).  The DAB considers this prima facie case requirement/burden shifting to apply to all cases adjudicated under the Part 498 regulations, including cases involving

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the revocation of enrollment in the Medicare program.  Adora Healthcare Services, Inc., DAB No. 2714 at 3-4 (2016); Medisource Corp., DAB No. 2011 at 2-3 (2006).

CMS revoked Petitioner’s Medicare enrollment and billing privileges based on 42 C.F.R. § 424.535(a)(14)(i).  That provision allows CMS to revoke a physician who has a pattern or practice of prescribing Medicare Part D drugs that is abusive or represents a threat to the health and safety of Medicare beneficiaries, or both.  In making the determination as to whether a physician should be revoked under this regulation, CMS may consider eight factors:  1) whether there are diagnoses to support the indications for which the drugs were prescribed; 2) whether the necessary evaluation of the patient for whom the drugs were prescribed could not have occurred; 3) whether the physician has prescribed controlled substances in excess dosages that are linked to patient overdoses; 4) the number and type of disciplinary actions taken against the physician by state licensing boards and the reasons for the action(s); 5) whether the physician has a history of final adverse actions as that term is defined in 42 C.F.R. § 424.502; 6) the number and types of malpractice suits filed against the physician related to prescribing; 7) whether any state Medicaid program, or any other public or private health insurance program has restricted, suspended, revoked, or terminated the physician’s ability to prescribe medications; and 8) any other relevant evidence provided to CMS.  42 C.F.R. § 424.535(a)(14)(i)(A)‑(H).

In its initial determination, reconsidered determination, and brief in this case, CMS does not assert that all eight of the factors above apply to this case.  I conclude that the record directly implicates three of the specific factors and the final general factor enumerated in § 424.535(a)(14)(i).  These factors are:

• Whether the physician has prescribed controlled substances in excess dosages that are linked to patient overdoses.
• The number and type of disciplinary actions taken against the physician by state licensing boards and the reasons for the action(s).
• Whether the physician has a history of final adverse actions as that term is defined in 42 C.F.R. § 424.502.
• Any other relevant evidence provided to CMS.

Below, I first make findings and conclusions concerning these factors and then consider whether those factors factually and legally support revocation under 42 C.F.R. § 424.535(a)(14)(i).  For efficiency and clarity, I first make general findings applicable to the case and then consider Petitioner’s state licensing disciplinary history and final adverse action history together due to overlapping facts for those factors.  Next, I will consider the prescribing practices related to seven beneficiaries under the “other relevant

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evidence” factor and, finally, the factor concerning two beneficiaries who had overdose events.

General Findings

1. Opioid analgesic are controlled substances that are commonly prescribed to treat pain. These drugs include morphine, oxycodone (i.e.: OxyContin), hydrocodone/acetaminophen (i.e.: Vicodin, Norco), and hydromorphone (i.e.: Exalgo Dilaudid).  Opioid pain medication use presents serious risks, including overdose and opioid use disorder.  Healthcare professionals measure the potency of different opioid drugs during a 24-hour period by calculating and converting each into a standard measurement called a morphine milligram equivalent (MME), also known as morphine equivalent dose (MED).1   By converting all medications prescribed for an individual into MME the chance for an accidental overdose is reduced.  Relevant to this case, in 2013, CMS policy indicated that 120mg MME per day was a factor it considered when determining if a Medicare beneficiary may be receiving too many opioids.  In March 2016, the CDC found that prescribing 90mg MME per day should be avoided or carefully justified due to the risk of death from overdosing.  In March 2017, the Virginia Board of Medicine promulgated a regulation that required a physician prescribing over 120mg MME per day to document the reasons for doing so.  In 2018, CMS conformed its policy concerning opioid overutilization by beneficiaries to the CDC’s 90mg MME per day amount.

“Opioids are a class of powerful narcotic medicines that are used to treat pain severe enough to warrant use of an opioid when other pain medicines cannot be taken or are not able to provide enough pain relief.  They also have serious risks including misuse and abuse, addiction, overdose, and death.”  CMS Ex. 35 at 1.  According to the CDC, opioids are commonly prescribed for the reduction of pain and that 20% of patients complaining of non-cancer pain symptoms received opioid prescriptions.  CMS Ex. 22 at 3.  The CDC acknowledged that a significant portion of the American population suffers from chronic pain, which the CDC defined as lasting for more than three months.  CMS Ex. 22 at 3.  For chronic pain, the CDC raised concerns over the efficacy of prescribing opioids.

Clinicians should consider the full range of therapeutic options for the treatment of chronic pain.  However, it is hard to estimate the number of persons who could potentially

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benefit from opioid pain medication long term.  Evidence supports short-term efficacy of opioids for reducing pain and improving function in noncancer nociceptive and neuropathic pain in randomized clinical trials lasting primarily ≤12 weeks, and patients receiving opioid therapy for chronic pain report some pain relief when surveyed.  However, few studies have been conducted to rigorously assess the long-term benefits of opioids for chronic pain (pain lasting >3 months) with outcomes examined at least 1 year later.

CMS Ex. 22 at 4; see P. Ex. 1 at 1.

In July 2013, CMS issued a policy concerning the overutilization of opioids by Medicare beneficiaries.  CMS Ex. 19.  CMS provided several factors for detecting overutilization of opioids of which one was whether a beneficiary was receiving greater than 120mg MME per day for at least 90 days.  CMS Ex. 19 at 3.

In March 2016, the CDC warned that opioid medications present a serious risk to patients, including overdose and opioid use disorder, noting that from 1999 to 2014, more than 165,000 people died in the United States from overdoses of opioid pain medications and that death rates in the decade preceding 2016 showed a continued rise in death from opioid medications.  CMS Ex. 22 at 4; see CMS Ex. 35 at 4 (“Opioids also carry serious risks, including misuse and abuse, addiction, overdose, and death.”); P. Ex. 1 at 1.

Because of the dangers of opioid use, the CDC recommended to practitioners that they discuss with patients the safety concerns such as increased risk for respiratory depression and overdose.  CMS Ex. 22 at 32.  This is because opioids depress the central nervous system (CNS), causing sedation and respiratory depression.  As opioid dosages increase, so does the risk of overdose.  Opioid overdose slows or stops the breathing process, which in turn decreases the amount of oxygen sent to the brain, and can lead to coma, brain damage, or death.  CMS Ex. 54 ¶ 15.

To provide health care professionals with a standard measurement by which they can calculate the potency of one or more different opioids taken by a patient, the MME was created.  CMS Ex. 52 ¶ 19; CMS Ex. 54 ¶ 16.  To calculate the MME, “[a] conversion factor based on the strength of each medication is applied to the different opioids a patient is prescribed, and a single number is generated that shows how much morphine the patient would be receiving if all of the various opioids taken were converted to morphine.”  CMS Ex. 52 ¶ 19; see CMS Ex. 54 ¶ 16.

Studies cited by the CDC found that opioid-related overdose risk is dose dependent, with higher opioid dosages associated with increased overdose risk.  Compared with opioids prescribed at less than 20mg MMEs per day, the odds of an overdose were between 1.3

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and 1.9 for dosages of 20mg to 50mg MMEs per day, between 1.9 and 4.6 for dosages of 50mg to 100mg MMEs per day, and between 2.0 and 8.9 for dosages of 100mg MMEs or more per day.  CMS Ex. 22 at 13.  One study stated the following:

A recent study of Veterans Health Administration patients with chronic pain found that patients who died of overdoses related to opioids were prescribed higher opioid dosages (mean: 98 MME/day; median: 60 MME/day) than controls (mean: 48 MME/day, median: 25 MME/day).

CMS Ex. 22 at 15.

As a result, the CDC stated that practitioners should:  use caution when prescribing opioids at any dosage; prescribe the lowest effective dosage; carefully reassess evidence of individual benefits and risks when increasing dosages to 50mg MME or more per day; and avoid or carefully justify titrating dosages to 90mg MME or more per day.  CMS Ex. 22 at 18; P. Ex. 1 at 2; Tr. 16-17; Tr. 140.  It may be appropriate to prescribe more than 90mg MME if properly justified.  Tr. at 23.  However, a clinical study found that an MME of greater than 200mg per day “was associated with a particularly high risk of opioid-related deaths (a nearly three-fold increase in the risk of opioid-related mortality when compared to patients with a MED of 20mg/day).”  CMS Ex. 52 ¶ 21, citing CMS Ex. 28 at 1, 3, 5.

In March 2017, the following regulations promulgated by the Virginia Board of Medicine became effective, which are similar to the CDC’s guidance:

In initiating treatment with an opioid, the practitioner shall:

1. Carefully consider and document in the medical record the reasons to exceed 50mg MME/day;
2. Prior to exceeding 120mg MMME/day, the practitioner shall document in the medical record the reasonable justification for such doses or refer to or consult with a pain management specialist.

CMS Ex. 24 at 6; June 30, 2020 Joint Stipulation ¶ 10.

In February 2017, CMS proposed to change its opioid overutilization criteria by accepting the CDC’s 90mg MME per day threshold to determine whether an individual is overutilizing opioids.  P. Ex. 1 at 10.  In April 2018, CMS lowered its threshold from 120mg MME per day to 90mg MME per day as a factor in determining whether Medicare beneficiaries may be overutilizing opioids.  CMS Ex. 27 at 5.

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In the present case, Petitioner argues that there is no specific amount of MME per day above which a physician is prohibited from prescribing.  P. Br. at 10-14.  CMS asserts that it had set a limit for determining opioid overutilization in 2013, which was above 120 mg MME per day, and updated that amount in 2018 to 90mg MME per day based on CDC guidance in March 2016 setting 90mg MME per day as the highest safe MME per day amount.  CMS Br. at 6-7.

Petitioner’s patients who are discussed in this case sometimes saw Petitioner before the March 2016 CDC guidance was issued, sometimes after, and sometimes both before and after.  Further, some of these patients were seen after the Virginia Board of Medicine’s March 2017 regulation set 120mg MME per day as the amount at which a practitioner must document the reasons for prescribing such an amount.  Therefore, there is a changing standard throughout the time-period relevant to this case.

For purposes of this case, whether it is 90mg MME per day or 120mg MME per day is not particularly important because Petitioner prescribed amounts well in excess of those amounts.  Generally, Petitioner was prescribing opioids at a high enough dosage that, even in 2015, a practitioner would have known that there were risks to the health of the patients.  As indicated in the Virginia regulation and perhaps implied in the CMS guidance, the determination as to whether an MME dosage is risky depends on the justification for that dosage.  As explained below, a review of Petitioner’s medical records reveals that Petitioner rarely provided a sufficient justification for the high dosages for the opioids he prescribed.  The expert witnesses were particularly concerned at the lack of clear documentation.  Therefore, I will reference the 90mg MME per day and 120mg MME per day levels as basic amounts where safety becomes an issue; however, it is generally not in dispute that none of the patients received opioids near that level of dosage or, if they did for a time, those prescriptions are not an issue of concern.

2. The CDC determined that taking opioids in combination with benzodiazepines increases the risk for a fatal opioid overdose, and the FDA decided to use its strongest warning on drug labels against that combination of drugs.

“Benzodiazepines are a class of medications used for multiple indications including sedation, treatment of insomnia, treatment of seizures and muscle spasms, and treatment of psychiatric disorders such as anxiety.  They are also CNS depressants, like opioids.”  CMS Ex. 54 ¶ 17; see CMS Ex. 35 at 4.  According to the CDC’s analysis in its March 2016 guidance document, when opioids are paired with other CNS depressants, such as benzodiazepines, muscle relaxants, or hypnotics, the risk of a fatal opioid overdose and patient harm are compounded.  CMS Ex. 22 at 32, 34; see CMS Ex. 22 at 31 (indicating that opioids combined with benzodiazepines is an example of a “dangerous combination”).  The CDC went so far as to warn that “[c]linicians should avoid

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prescribing opioids and benzodiazepines concurrently whenever possible.”  CMS Ex. 22 at 32.

The FDA agreed with the CDC and determined in August 2016 that the evidence of risk when combining opioids and benzodiazepines was so great that it added its strongest warning (i.e., “Boxed Warnings”) to drug labelling.  CMS Ex. 35 at 1-2.  A significant problem is that “[b]oth opioids and benzodiazepines depress the central nervous system (CNS).”  CMS Ex. 35 at 4.  The FDA made its decision to provide its strongest drug label warning based on the results of four studies concerning the concomitant use of opioids and benzodiazepines.  CMS Ex. 35 at 6-9.  The FDA stated the following in its 2016 Safety Announcement:

Health care professionals should limit prescribing opioid pain medicines with benzodiazepines or other CNS depressants only to patients for whom alternative treatment options are inadequate.  If these medicines are prescribed together, limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect. Warn patients and caregivers about the risks of slowed or difficult breathing and/or sedation, and the associated signs and symptoms.  Avoid prescribing prescription opioid cough medicines for patients taking benzodiazepines or other CNS depressants, including alcohol.

CMS Ex. 35 at 1; see Tr. 44 (“The combination of opioids and benzodiazepines is considered high risk.”); Tr. 167-168 (explaining why prescribing opioids and benzodiazepines at the same time are a “tremendous risk” and that it is difficult to minimize that risk.).

In March 2017, the following regulations promulgated by the Virginia Board of Medicine became effective, which are similar to the CDC’s guidance:

Due to the higher risk of fatal overdose when opioids, including buprenorphine are given with other opioids, benzodiazepines, sedative hypnotics, carisoprodol, and tramadol, the prescriber shall only co-prescribe these substances when there are extenuating circumstances and shall document in the medical record a tapering plan to achieve the lowest possible effective doses of these medications if prescribed. 

CMS Ex. 24 at 6; June 30, 2020 Joint Stipulation ¶ 10.

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State License Disciplinary History and History of Final Adverse Actions

3. Petitioner was licensed to practice medicine in Virginia in 1991. In June 2004, Petitioner agreed to resolve charges of professional misconduct made against him by authorizing the Virginia Board of Medicine to issue a Consent Order suspending Petitioner’s medical license until Petitioner could prove he should be reinstated.  The Consent Order detailed Petitioner’s misconduct, which spanned most of the time he was licensed to practice medicine, and included numerous instances of improper monitoring and prescribing of opioids and other controlled substances.

The Virginia Board of Medicine licensed Petitioner to practice medicine on August 30, 1991.  After holding an informal conference with Petitioner on April 14, 2004, to inquire into allegations that Petitioner violated the laws governing the practice of medicine in Virginia, a Virginia Board of Medicine committee referred Petitioner for a formal administrative hearing to consider whether to suspend or revoke his medical license.  In lieu of a formal hearing, in June 2004, Petitioner agreed to resolve his misconduct through a Consent Order.  CMS Ex. 3 at 1; June 30, 2020 Joint Stipulation ¶¶ 1-2.

In the Consent Order, the Virginia Board of Medicine made the following findings of fact and conclusions of law:

• In violation of Virginia law, Petitioner provided substandard patient care from November 1993 to November 2002.

• Petitioner failed to perform thorough or comprehensive evaluations of the chronic pain complaints for five patients.
• Petitioner failed to refer the same five patients for appropriate consultations by other physicians.
• Petitioner failed to have six patients enter into chronic pain management contracts that show each patient’s agreement to abide by standards for chronic pain management involving opioids.
• Petitioner failed, at the initiation of treatment for nine patients, to obtain or document information regarding the history of substance abuse from the patients.
• Petitioner failed, for patients with known histories of abuse or addiction to opioids, to perform adequate examinations, testing, or review related to the course of treatment, etiology of the pain, or patient’s compliance with

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• medication usage, including urine/serum screening and monitoring the number and frequency of all prescriptions.
• Petitioner failed to comply with his own treatment plan to cease further prescriptions for opioids for four patients without documenting the reason for doing so.
• Petitioner failed to follow his treatment plan to detoxify three patients in heroin withdrawal without documenting the reason for doing so.
• Petitioner often failed to cease prescribing opioid medications for patients after becoming aware of their excess use and/or arrests for attempting to obtain medications by illegal means.
• Petitioner failed to pay attention to the patterns of abuse for eight patients and often provided refills for their opioid medications earlier than expected.
• Petitioner met patients outside his office (e.g., restaurants, parking lots) to give them prescriptions without examination, billing for services, and, at times, without documenting the event.

• In violation of Virginia law, Petitioner provided substandard patient care from October 1996 to October 2002, by providing unauthorized detoxification services.

• Petitioner failed to have his practice certified or registered with the DEA to provide detoxification services but provided five patients with opioids in the outpatient setting to detoxify them.
• Petitioner failed to closely monitor the prescriptions for five patients or order rehabilitation to complete the detoxification process.

• In violation of Virginia law, Petitioner had inappropriate physical and sexual contact with two female patients concurrent with his treatment of the patients and by virtue of the practitioner-patient relationship.

• In 1997 and 1998, Petitioner engaged in sexual intercourse with two of Petitioner’s patients at his residence, which also served as the location for his private practice.
• One of the patients with whom Petitioner engaged in intercourse credibly stated that she felt Petitioner would cease to treat her with opioids for her recurrent episodes of pain if she failed to engage in sexual activity with him.

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• Petitioner often met the other patient with whom he had intercourse at public establishments and parking lots to provide her with prescriptions.

• In violation of Virginia law, Petitioner prescribed an anorectic drug, Phentermine hydrochloride (C-IV), to a patient for weight reduction or control without proper monitoring.

• Petitioner failed to weigh the patient at least once a month, record her vital signs, and to perform other appropriate tests for monitoring adverse effects of her drug therapy.
• Petitioner continued to prescribe Phentermine beyond a 90-day period contrary to anorectic regulations.

• Petitioner’s “medical record-keeping was grossly inadequate.”
• Petitioner “displayed insufficient knowledge of the standards of practice for chronic pain management, opioid abuse and bariatric medicine.”

CMS Ex. 3 at 1-5.

With the express consent of Petitioner, the Consent Order ordered the following:

• Petitioner’s Virginia medical license was suspended.
• If Petitioner sought reinstatement of his medical license, Petitioner had the burden of proving his competency and fitness to practice medicine in Virginia in a safe manner.
• Petitioner had to surrender his DEA certificate and DEA 22 Schedule II order forms to the DEA.

CMS Ex. 3 at 6-7.

4. Petitioner requested reinstatement of his medical license in Virginia; however, in 2009, the Virginia Board of Medicine denied his request.  The Virginia Board of Medicine found that the North Carolina Medical Board had revoked Petitioner’s medical license in 2005 and that Petitioner had failed to show he had completed a clinical competency program and courses in medical record keeping and professional boundaries.  In 2012, the Virginia Board of Medicine reinstated Petitioner’s medical license with conditions and, in 2014, removed all

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1. conditions from his license. There is no evidence that North Carolina Medical Board has reinstated Petitioner’s medical license.

Petitioner sought reinstatement of his Virginia medical license in 2008.  The Virginia Board of Medicine held an informal conference and, in a January 8, 2009 Order, denied Petitioner’s reinstatement request.  CMS Ex. 4.

The Order included the following findings of fact and conclusions of law:

• Petitioner’s license to practice medicine in North Carolina was revoked on or about December 8, 2005, based on the Consent Order issued in 2004 by the Virginia Board of Medicine.
• Petitioner obtained Continuing Medical Education in various areas including a mini-residency in proper prescribing.
• Petitioner claimed that he had no plans to return to the practice of chronic pain management and that he would focus on primary care.
• Petitioner failed to provide objective evidence of his current clinical competency or in-depth courses on professional boundaries or medical recordkeeping.

CMS Ex. 4 at 1-3.

In the Order, the Virginia Board of Medicine ordered the following:

• Petitioner’s reinstatement request was denied and that his medical license remained on indefinite suspension.
• Petitioner was authorized to seek reinstatement again after he completed a comprehensive clinical competency assessment and additional Continuing Medical Education in recordkeeping and professional boundaries.

CMS Ex. 4 at 3-4.

Petitioner again sought reinstatement of his medical license.  In an Order signed on January 19, 2012, the Virginia Board of Medicine granted reinstatement with several conditions.  CMS Ex. 5.  In a January 16, 2014 letter, the Virginia Board of Medicine terminated the conditions placed on Petitioner’s medical license.  CMS Ex. 6; June 30, 2020 Joint Stipulation ¶ 3.  The record does not indicate that Petitioner’s North Carolina medical license was reinstated.

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5. Petitioner’s disciplinary history concerning his medical license and the reason for the discipline provides significant support under 42 C.F.R. § 424.535(a)(14)(i)(D) and (E) to revoke Petitioner’s Medicare enrollment. Petitioner’s exclusion from participation in all federal health programs provides additional support for the revocation under 42 C.F.R. § 424.535(a)(14)(i)(E).

Two factors to consider when determining whether a provider or supplier has engaged in a pattern or practice of prescribing Medicare Part D drugs that is abusive or represents a threat to the health and safety of Medicare beneficiaries are:

• (D) The number and type(s) of disciplinary actions taken against the physician or eligible professional by the licensing body or medical board for the State or States in which he or she practices, and the reason(s) for the action(s).
• (E) Whether the physician or eligible professional has any history of “final adverse actions” (as that term is defined in § 424.502).

42 C.F.R. § 424.535(a)(14)(i)(D), (E).

The term “final adverse action” is defined as including the following:

• Suspension or revocation of a license to provide health care by any State licensing authority.
• An exclusion or debarment from participation in a Federal or State health care program.

42 C.F.R. § 424.502.

Most significant to this case is that, in June 2004, the Virginia Board of Medicine indefinitely suspended Petitioner’s medical license.  As part of that Consent Order, Petitioner agreed to surrender his DEA certificate and Schedule II order forms.  CMS Ex. 3 at 7.  As stated above, the Virginia Board of Medicine took this action due to Petitioner’s misconduct that directly/indirectly related to prescribing controlled substances, maintaining documentation concerning those prescriptions, and sexual misconduct with patients who were seeking controlled substances.  Specifically:

• Dr. Greene failed to perform thorough or comprehensive evaluations of the chronic pain complaints of his patients, and failed to refer the patients for appropriate consultations by other physicians.

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• Dr. Greene failed to obtain and/or document information regarding a history of substance abuse in his patients, and where there was a history of ongoing abuse and opioid addiction. Dr. Greene failed to perform an adequate examination, and monitor the patient’s compliance, screenings, and frequency of all prescriptions.
• Dr. Greene often continued prescribing opioids even after becoming aware of a patient’s excessive use, or attempts to illegally obtain medications.
• Dr. Greene provided patients with early opioid refills.
• Dr. Greene engaged in inappropriate sexual misconduct with patients.

CMS Ex. 3 at 2-5.  Additionally, the Virginia Board of Medicine determined that Dr. Greene’s medical record keeping “was grossly inadequate” and he “displayed insufficient knowledge of the standards of practice for chronic pain management [and] opioid abuse . . . .”  CMS Ex. 3 at 5.

Based on Virginia’s license suspension, the North Carolina Medical Board revoked Petitioner’s medical license in that state.  CMS Ex. 4 at 2.

Therefore, the record shows, and Petitioner does not dispute, that disciplinary action was taken by two states against medical licenses he had in those states.  The type of sanction imposed is significant because Virginia’s suspension was indefinite, signaling that Petitioner may never resume practice unless he met specific requirements.  It is no less important that North Carolina fully revoked Petitioner’s license and Petitioner has never obtained a North Carolina medical license again.

The reasons for these states to impose such a high-level of discipline are most pertinent to the present case.  It involves improper prescribing of controlled substances and a failure to adequately document the medical records of his patients related to prescriptions.  The connection between Petitioner’s past misconduct and CMS’s current allegations of misconduct are very similar.  Therefore, this factor weighs heavily in favor of revocation in this case.

It does so in part because years after his Virginia license was suspended, Petitioner sought reinstatement and could not prevail because he failed to provide evidence of his clinical competency or evidence of completing in-depth courses on professional boundaries and medical recordkeeping.  CMS Ex. 4 at 2-3.  It then took years longer for Petitioner to secure reinstatement of his license, with restrictions, in January 2012.  CMS Ex. 5 at 3-5.  It was not until January 16, 2014, nearly ten years after the license was first suspended, that Petitioner’s medical license was reinstated in Virginia without any restrictions.  CMS Ex. 6.  But, only a little more than a year later, as CMS alleges, prescribing misconduct by Petitioner began again.

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Regarding the history of final adverse actions imposed on Petitioner, in addition to the state disciplinary history discussed above, the Inspector General for the U.S. Department of Health and Human Services also excluded Petitioner from participating in Medicare, Medicaid, or any federal health care programs beginning January 19, 2005, and lasting through August 24, 2014.  CMS Ex. 20 at 7.  While the record is limited as to why this exclusion was imposed, it is likely that the Inspector General exercised discretion to impose a “permissive” exclusion based on Petitioner’s medical license suspension in Virginia.  42 C.F.R. § 1001.501.  Therefore, the Inspector General deemed the basis for the license suspension sufficiently disconcerting to independently impose the exclusion.

The factors discussed here are particularly strong in the present case because Petitioner’s state disciplinary history shows that Dr. Greene was already educated about the importance of proper opioid prescription, prescription management, and recordkeeping in order to be reinstated to practice.  As discussed below, CMS has shown that Petitioner continues to practice with those same problems.

Other Relevant Evidence – Petitioner’s Prescribing Practices with Seven Medicare Beneficiaries

CMS considered Petitioner’s prescribing history with seven Medicare beneficiaries.  I discuss the facts related to each below.

6. Greene prescribed at least two opioid analgesic controlled substances each month for T.G. from approximately June 2017 through April 2018. Petitioner generally prescribed over 200mg MME per day for T.G., amounts in excess of the 90mg/120mg MME per day level at which there is an elevated risk for an overdose.  In addition, T.G. tested positive for alprazolam (Xanax), a benzodiazepine, while receiving opioids from Petitioner; however, Petitioner did not follow-up on this positive test result despite the risk that taking opioids and a benzodiazepine pose.  Further, Petitioner prescribed carisoprodol (Soma) for T.G. while T.G. was taking opioids, which posed additional risks.  Petitioner provided insufficient justification in the medical record for these actions/inactions.

T.G. presented to Dr. Greene’s clinic on June 20, 2017, with complaints of a 20-year history of chronic lower back, right leg, and shoulder pain.  CMS Ex. 9 at 1-2, 88; see also 104-109.  T.G.’s medical history was significant for chronic obstructive pulmonary disease (COPD), emphysema, migraines, and a past history of a brain aneurysm.  CMS Ex. 9 at 2.

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At the initial visit, Petitioner prescribed 150 pills of hydrocodone/acetaminophen (Norco) 325mg/10mg, and 150 pills of oxycodone (OxyContin) 30mg.  CMS Ex. 9 at 89, 98, 110, 112.

Examination notes from T.G.’s follow-up visit with Dr. Greene on July 18, 2017, indicate that T.G. has been taking oxycodone (OxyContin) 30mg for “many years,” as well as hydrocodone/acetaminophen (Norco), and “states that her pain is stable,” but also notes that “her pain level today and through out [sic] the month has been a 9/10.”  CMS Ex. 9 at 85; see also CMS Ex. 9 at 14 (indicating the worst pain last week was a 10 and the least pain was a 7).  T.G. stated that her usual pain had not improved since her last visit.  CMS Ex. 9 at 14.  Petitioner determined that he would “continue meds as they are.”  CMS Ex. 9 at 85.  Petitioner prescribed oxycodone (OxyContin) 30mg and hydrocodone/acetaminophen (Norco) 325mg/10mg.  CMS Ex. 9 at 86, 100, 113-114.

During an August 15, 2017 follow-up visit, T.G. had pain varying from 7 to 10 and her usual pain had not improved from the previous visit.  CMS Ex. 9 at 15, 82.  Petitioner prescribed oxycodone (OxyContin) 30mg and hydrocodone/acetaminophen (Norco) 325mg/10mg for T.G.  CMS Ex. 9 at 82, 101, 115-116.

Examination notes from a September 12, 2017 follow-up visit, indicate an MME of 178mg, and state that T.G.’s “pain level is 8/10 with the medication and the high last week was 9.”  CMS Ex. 9 at 17, 79.  T.G.’s usual pain had not improved since the previous visit.  CMS Ex. 9 at 17.  The medication list reflects a change from oxycodone (OxyContin) to hydromorphone HCl (Exalgo).  CMS Ex. 9 at 79, 102, 117; CMS Ex. 21 at 1.  The notes indicate that the OxyContin “[d]id not help with the pain.”  CMS Ex. 9 at 80.  Petitioner also prescribed hydrocodone/acetaminophen (Norco) 325mg/10mg.  CMS Ex. 9 at 118.  Petitioner indicated that T.G.’s current MME was 178.  CMS Ex. 9 at 79.

The medical record notes dated two days later, on September 14, 2017, state:

[S]poke with [T.G.] today and she stated that the new medication exalgo is making her sick and she is throwing up[.]  She told me that she wanted to go back to her oxycodone and that she had seven days left.  I told her to stop taking the new medication and go back to the old and come in on Monday to pick up an RX of her old medication.

CMS Ex. 9 at 78.  The record indicates that T.G. initially filled a 30-day supply of hydromorphone HCl (Exalgo) and hydrocodone/acetaminophen (Norco), and then filled an additional supply of oxycodone (OxyContin).  CMS Ex. 21 at 1.  There is no evidence that Dr. Greene required T.G. to return or dispose of the unused hydromorphone HCl (Exalgo).  See CMS Ex. 9 at 78.  In a September 18, 2017 prescription, Petitioner increased the dose of oxycodone (OxyContin) to 60mg.  CMS Ex. 9 at 102-103, 119.

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During an October 10, 2017 follow-up visit, T.G. indicated that her pain during the previous week was between 5 and 7, and her pain had improved since the previous visit.  CMS Ex. 9 at 19.  Petitioner prescribed oxycodone (OxyContin) at 60mg, hydrocodone/acetaminophen (Norco) at 325mg/10mg.  T.G.’s Prescription Drug Monitoring Program chart (PDMP) also indicates that on October 9, 2017, another provider prescribed alprazolam (Xanax) at 2mg.2   CMS Ex. 9 at 75, 102-103, 120-121.  Petitioner noted that the MME was 230mg.  CMS Ex. 9 at 75.

During a November 7, 2017 follow-up visit, T.G. indicated that her pain during the previous week was between 7 and 8, and indicated that her pain had not improved since the previous visit.  CMS Ex. 9 at 21.  Petitioner prescribed oxycodone (OxyContin) 40mg, and hydrocodone/acetaminophen (Norco) 325mg/10mg.  CMS Ex. 9 at 72-73, 103, 122-123.  Petitioner noted that the MME was 230mg.  CMS Ex. 9 at 72.

During a December 5, 2017 follow-up visit, T.G. indicated that her pain during the previous week was between 6 and 9.  CMS Ex. 9 at 23.  Beginning December 5, 2017, Dr. Greene prescribed T.G. carisoprodol (Soma), a muscle relaxant, in combination with hydrocodone/acetaminophen (Norco) 325mg/10mg, and oxycodone (OxyContin) at a dose of 40mg.  CMS Ex. 9 at 69, 125-127; CMS Ex. 21 at 1.  Petitioner noted that the MME was 230mg.  CMS Ex. 9 at 69.

T.G. had follow-up visits with Petitioner on January 3, January 31, and March 5, 2018, at which T.G. stated that her pain was not optimally controlled with pain medication.  Petitioner continued prescribing hydrocodone/acetaminophen (Norco) 325mg/10mg and oxycodone (OxyContin) at a dose of 40mg and estimated the MME was 230mg.  CMS Ex. 9 at 30-32, 34-35, 38-39.

Dr. Greene routinely refilled T.G.’s prescriptions before the prescriptions were scheduled to run out.  Notably, from April 2, 2018, through April 30, 2018, Dr. Greene prescribed T.G. a total of 300 pills of hydrocodone/acetaminophen 325mg/10mg; 180 pills of oxycodone (OxyContin) 40mg; 60 pills of zolpidem tartrate (Ambien) 12.5mg; 60 pills of mirtazapine (Remeron) 15mg; and 60 pills of venlafaxine HCl Cap ER (Effexor XR) 75mg.  CMS Ex. 21 at 1.  Additionally, T.G. had also been receiving alprazolam (Xanax) from another provider.  CMS Ex. 9 at 128-146; see CMS Ex. 21 at 1.

Dr. Sullivan testified that during Petitioner’s care of T.G., T.G. was prescribed “opioid doses well over 120 MME.”  She calculated the MME for T.G. after the first visit with Petitioner in June 2017 as 275mg MME per day and the last visit for the period considered by MEDIC as 256.7mg MME per day, which Dr. Sullivan believed put T.G.

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at elevated risk for opioid overdose.  CMS Ex. 54 ¶ 35; see Tr. at 64-70 (clarifying that the initial MME amount is based on the June 2017 initial visit with Petitioner).  She also testified to the following:

In one beneficiary, T.G., Dr. Greene had [urine drug screen] results that noted alprazolam (a benzodiazepine) which was not prescribed by Dr. Greene.  In addition to not addressing this inconsistent laboratory result with the beneficiary, Dr. Greene subsequently added carisoprodol [commonly called Soma], a commonly abused muscle relaxant which is also a controlled substance, in addition to the high opioid dosages prescribed.  Opioids, benzodiazepines, and carisoprodol in combination is known as the “trio” or “trinity” and is commonly sought by drug seeking beneficiaries.  Dr. Greene’s failure to address the undocumented alprazolam and his prescribing of carisoprodol in addition to the high dose opioids (with alprazolam noted) documents a failure to address a high risk behavior putting Beneficiary T.G. at risk for [opioid use disorder] and subsequent harm.

CMS Ex. 54 ¶ 41.

Dr. Sullivan acknowledged that, according to a PDMP for June 2016 to June 2017, T.G. had been receiving opioids for some time at elevated MME levels before being treated by Petitioner.3   Tr. at 72-74.  Dr. Sullivan also indicated that for T.G., the MME at the beginning of treatment by Petitioner was a little higher than at the end, and acknowledged that it would be feasible to maintain patients on more than 90 or 120 MME if they had previously been on higher amounts.  See Tr. at 74-75.

Dr. Humpert raised similar concerns as Dr. Sullivan in his written testimony.  He also indicated that Petitioner prescribed opioids (hydrocodone and oxycodone) in combination with carisoprodol (Soma), which:

[C]reates a potent, euphoric high known as the “Soma coma.”  Any healthcare professional is aware of Soma’s effect and the risks of abuse, and any conscientious professional would avoid prescribing a patient Soma in combination with opioids, if possible. . . .  Thus both the quantity and the combination of

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drugs prescribed by [Petitioner] was dangerous and without legitimate medical purpose.

CMS Ex. 52 ¶ 40.  Based on Dr. Humpert’s review of the medical records, Petitioner prescribed carisoprodol (Soma) for 30 days for chronic pain “without justification,” which “greatly increased the risk of harms to T.G., including drug misuse, respiratory depression, overdose, and death.”  CMS Ex. 52 ¶ 42.

Dr. Humpert also testified that T.G. had been receiving alprazolam (Xanax) from another prescriber and that had Petitioner been checking the state drug prescription database (i.e., the PDMP) each time T.G. visited, Petitioner would have known that T.G. had been receiving benzodiazepines (alprazolam) from another prescriber.  CMS Ex. 52 ¶¶ 34, 41.  He went onto testify:

Had Dr. Greene been checking the PDMP at each visit, he would have seen that T.G. had been receiving benzodiazepines, thus completing the trio of drugs (opioid, benzodiazepine, carisoprodol).  While Dr. Greene included copies of the PDMP report with T.G.’s medical record, he made no effort to document potential risks or adverse interactions with medication that patients were receiving from other prescribers.  It is the standard of care for physicians to obtain at every office visit a current list of all medications, both prescription and non-prescription, taken by their patients, in order to minimize potentially harmful interactions.  Dr. Greene’s failure to comply with this standard put T.G. at increased risk of misuse, overdose, and death.

CMS Ex. 52 ¶ 41.

Dr. Humpert also testified that Petitioner prescribed two short-acting opioids (oxycodone (OxyContin) 30mg and hydrocodone/acetaminophen (Norco) 10/235mg) for the first three months that he saw T.G. at the highest available strengths but did not document a rationale for this.  CMS Ex. 52 ¶ 28.  Dr. Humpert stated that “[t]his is very troubling, as the use of two short-acting opioids at the maximum strengths increased the risk of overdose and dependency on opioids.”  CMS Ex. 52 ¶ 28.

It is possible that Dr. Humpert is incorrect regarding his statement that Dr. Greene was unaware that T.G. was receiving alprazolam (Xanax) from another provider.  It is clear from the toxicology tests administered to T.G. that Dr. Greene had knowledge that another provider was prescribing a benzodiazepine, completing the potentially deadly trifecta of an opioid, benzodiazepine, and a muscle relaxant, the combination of which greatly increases the risk of respiratory depression, overdose, and death.

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In his brief, Petitioner provides a history of his treatment of T.G., indicating an effort to try different drugs, but having some difficulty because T.G. would occasionally have adverse reactions.  Petitioner asserts that it was appropriate to prescribe two short acting opioids together and then a short and a long acting opioid together.  Petitioner also notes that “[i]t is interesting” that T.G.’s prior physician also prescribed both opioids and benzodiazepines.  P. Br. at 21.  In addition, Petitioner also asserts that the prescription for carisoprodol (Soma) was not for long-term use.  P. Br. at 25.

I find that Petitioner’s prescribing practices related to T.G. were a threat to T.G.’s health and safety.  Petitioner maintained T.G. at an MME level significantly higher than the generally safer 90mg or 120mg MME per day amount.  Added to this, Petitioner either was ignorant of or allowed, without question, T.G. to take a benzodiazepine from another provider.  Worse, he added a muscle relaxant.  Each and all of these factors represented an ever-increasing risk to T.G.  Without proper justification in the records or testimony from Petitioner, I cannot conclude that Petitioner engaged in appropriate prescribing for T.G.

7. Dr. Greene prescribed opioid analgesic controlled substances (hydromorphone HCl and morphine sulfate or methadone HCl) each month for W.F. from approximately August 2015 through October 2017. In August 2015 Petitioner prescribed 264mg MME per day and increased that through 2017 up to 645mg MME per day.  These were amounts well in excess of the 90mg/120mg MME per day level at which there is an elevated risk of an overdose.  In addition, Dr. Greene also prescribed diazepam (Valium) 2mg, a benzodiazepine, for W.F. as well as a muscle relaxant, which both posed additional risks to W.F.  Dr. Greene provided insufficient justification in the medical record for these actions.

Dr. Greene prescribed opioids and a benzodiazepine (diazepam) to W.F. for nearly two years based on diagnoses of degenerative disc disease, degenerative lumbar dextroscoliosis, and lower back pain.  CMS Ex. 10 at 89; CMS Ex. 21 at 2-4.  Visit notes authored by Petitioner and dated November 17, 2015, note that W.F.’s urine test came back positive for methadone, which Petitioner did not prescribe for W.F.  CMS Ex. 10 at 85.  W.F. stated that he accidentally took a few the previous month, because he had some left from a previous prescription.  CMS Ex. 10 at 85.  Dr. Greene explained to W.F. that this was a violation of the contract he signed regarding his care, but instead of discharging him immediately, Dr. Greene prescribed W.F. one week’s worth of his normal medication, conduct a new urine test, and if the urine test came back positive for methadone, W.F. would be discharged as a patient.  CMS Ex. 10 at 85.

Notes from a follow-up visit dated November 24, 2015, states that W.F.’s urine test came back negative for methadone, and “he is fine and he is able to get [a] month of his regular medication.”  CMS Ex. 10 at 82.  Dr. Greene then proceeded to prescribe an entire

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30‑day supply of opioids, even though he had already prescribed a week’s worth.  CMS Ex. 21 at 2.

In 2016, W.F. began filling prescriptions for diazepam (Valium), while simultaneously filling prescriptions for alprazolam (Xanax) prescribed by another provider.  CMS Ex. 10 at 159-179.  If Dr. Greene did notice the co-prescribed benzodiazepines in W.F.’s PDMP, he never questioned it, noted it, or explained why two concurrent benzodiazepines were appropriate.  CMS Ex. 8 at 7; CMS Ex. 10 at 166-176.

In addition to opioids combined with benzodiazepines, Dr. Greene also prescribed cyclobenzaprine, a muscle relaxant for W.F.  CMS Ex. 10 at 74, 82, 85, 87.

Beginning in February 2016, Dr. Greene began prescribing methadone to W.F.  CMS Ex. 21 at 2.  The record, however, lacks any documentation surrounding that decision or change.  In August 2015, W.F.’s daily MME was 264mg; by October 2017, W.F.’s daily MEE was 645mg.  See CMS Ex. 21 at 2, 4.

Dr. Sullivan testified that her review for the period of August 1, 2015 through December 31, 2017, indicated that W.F. started with 264mg MME and ended the period at 645mg MME.  CMS Ex. 54 ¶ 35; see Tr. 21-22 (indicating that high dose opioid prescribing was part of her risk analysis).  She testified that Petitioner’s commonly used diagnosis of “low back pain” for his patients is a “non-specific indication which does not correlate to the use of such high dose opioid regimens.”  CMS Ex. 54 ¶ 19.  In addition to the unwarranted high MME, Dr. Sullivan testified that Petitioner’s prescribing of methadone for W.F. increased the risk for overdose because methadone has a long half-life and is, therefore, “not considered a first line agent for pain management.”  CMS Ex. 54 ¶ 19.  Finally, Dr. Sullivan indicated that Petitioner’s prescribing of a benzodiazepine made the situation even worse.

Beneficiary W.F. was prescribed methadone and diazepam (a benzodiazepine) concurrently.  Methadone is not considered a first-line agent for pain control due to the high risk of opioid overdose due to its long half-life.  The addition of diazepam to high dose methadone further increased the already elevated risk of opioid overdose in this beneficiary.

CMS Ex. 54 ¶ 42.

Dr. Humpert’s review of W.F.’s record is consistent with Dr. Sullivan’s.  Dr. Humpert testified that Petitioner prescribed benzodiazepines to W.F. along with opioids.  CMS Ex. 52 ¶ 33.  He further testified that Petitioner did not document that W.F. was receiving prescriptions from another provider and prescribed diazepam (Valium) in addition to alprazolam (Xanax) (both benzodiazepines) from another provider, which heightened the

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risk for harm, including drug misuse, respiratory depression, and overdose.  CMS Ex. 52 ¶¶ 34, 36.

Dr. Humpert also believed that Petitioner’s prescription for a muscle relaxant to W.F. increased the risk of harm to W.F. without sufficient justification:

Dr. Greene prescribed to W.F. cyclobenzaprine (brand name Flexeril), a muscle relaxant, with two opioids, Dilaudid and morphine.  CMS Ex. 10 at 82-89.  Both classes of drugs are CNS depressants, and the effects of the drugs can compound when they are taken together.  Given the sedative and respiratory effects of both opioids and muscle relaxants, Dr. Greene increased the risk of harm without justification in the record.

CMS Ex. 52 ¶ 38.

Dr. Hirsch’s testimony also agreed with the other experts that Petitioner’s prescriptions to W.F. were unwarranted and dangerous.  He testified that in November 2015, W.F. received the muscle relaxant cyclobenzaprine and hydromorphone, and indicated the following concern:

The addition of a centrally acting muscle relaxant significantly increased the risk of central nervous system depression.  There was no justification for the selection and dosages of either the muscle relaxant or the opioids.  Cyclobenzaprine interacts with the hydromorphone and MS Contin to increase the risk of CNS and respiratory depression, psychomotor impairment, anticholinergic side-effects like constipation, and serotonin syndrome.  The patient was placed at risk for harm without adequate justification.

CMS Ex. 51 ¶ 3.2.3.  Dr. Hirsch also testified that, in October 2017, the “opioids and diazepam (a high dose) [prescribed to W.F.] placed the patient at significant increased risk of CNS and respiratory depression, psychomotor impairment, and death.”  CMS Ex. 51 ¶ 3.2.1.

Petitioner neither testified nor offered the testimony of any experts to contradict the opinions of these witnesses.  Instead, Petitioner argues in briefing that literature CMS submitted for the record shows that methadone is indicated for pain management severe enough to require around-the-clock, long-term opioid treatment when other alternatives are not adequate.  Further, Petitioner urges that “[c]oadministration of opioids and alprazolam (Xanax) is not noted as being contraindicated in the prescribing literature for

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either drug,” but admits that “[t]he risks of coadministration are profound sedation, respiratory depression, coma and death.”  P. Br. at 27.  Petitioner indicates that coadministration simply means that the patient needs to be monitored for signs of respiratory depression, sedation, and hypotension, and that “[t]he vitals for . . . W.F . . . were checked during [W.F.’s] visits which were normally once a month.”  P. Br. at 24, 27.

Petitioner’s response I his brief is insufficient to rebut the expert testimony that explained why Petitioner’s prescribing history for W.F. was unjustified and risky.  Petitioner escalated the MME per day for W.F. from 264mg to 645mg, without sufficient justification, placing W.F. at risk for overdose from the opioid prescriptions.  Again, he added to that risk by prescribing a benzodiazepine.  W.F. also received a benzodiazepine from another prescriber concurrently, but Petitioner did nothing regarding that prescription.  All of these actions/inactions increased the risk to W.F.  Simply because a practitioner may prescribe a certain combination of drugs while engaging in some monitoring does not mean it was appropriate, safe, and necessary, or that the monitoring was sufficient.  I find that the records involving W.F. show that Petitioner’s prescriptions represented a threat to the health and safety of W.F.

8. Dr. Greene prescribed an opioid analgesic controlled substance (methadone) each month for T.M. from approximately August 2015 through March 2016. In August 2015 Petitioner prescribed 600mg MME per day and increased that amount through March 2017, up to 1,080mg MME per day.  These were amounts in extreme excess of the 90mg/120mg MME per day level at which there is an elevated risk of an overdose.  Additionally, beginning December 2015, Dr. Greene also prescribed diazepam (Valium) or alprazolam (Xanax) for T.M., which increased the risks to T.M.  While under Dr. Greene’s care, T.M. died of blunt force trauma to his head when he fell down the stairs.  The cause of death finding noted that T.M. had acute methadone and alprazolam intoxication when he died.  Dr. Greene provided insufficient justification in the medical record for his prescriptions.

It is unclear when Dr. Greene initially began seeing T.M. as a patient, but on August 26, 2015, Petitioner prescribed for T.M. 180 pills of methadone HCl 10mg, with an MME of 600mg.  CMS Ex. 21 at 5.  The first documented patient visit is dated September 23, 2015, and notes that T.M. “presents for follow-up evaluation of back pain” and is “improving on treatment.”  CMS Ex. 11 at 22.  By October 6, 2015, Dr. Greene increased T.M.’s prescription to 200 pills of methadone HCl 10mg for 24 days, with an MME of 1000, nearly double T.M.’s initial MME.  CMS Ex. 21 at 5.  Patient notes from T.M.’s October 6, 2015 visit state:

Two weeks ago we add two pill of methadone in between because he was on 3 tab every 12 hour now he is taken 3 tabs

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[every] 12 hours plus two at noon time every day and he [says] that his pain is better but does not control his pain at all we will add one more and he will take 3 tablet every 8 hours.

CMS Ex. 11 at 20.

It appears that T.M. was initially on 6 tablets each day, then Dr. Greene changed the dosage to 8 tablets each day, where T.M.’s pain was both “better” and not controlled at all.  Dr. Greene did not explain this contradiction.

In November 2015, the record indicates that Petitioner increased the methadone to 1,080mg MME per day.  CMS Ex. 21 at 5.

On December 17, 2015, T.M. filled two prescriptions written by Dr. Greene.  The first was for diazepam (Valium), and the second for 252 pills of methadone HCl 10mg for 28 days, with an MME of 1,080mg.  CMS Ex. 21 at 5.  There is no mention of diazepam (Valium) in the patient notes for that visit, and no rationale for why Dr. Greene prescribed it to T.M.  CMS Ex. 11 at 15.  In addition, the notes from the previous November 19, 2015 visit state that T.M.’s visit was delayed because he had been sick with pneumonia and bronchitis.  CMS Ex. 11 at 18.  In January 2016, Dr. Greene added alprazolam (Xanax), and discontinued the diazepam (Valium), noting that T.M. was still not sleeping well, and he did not feel well in the morning on Valium.  CMS Ex. 11 at 12; CMS Ex. 21 at 5.

Dr. Greene started T.M.’s methadone dose at an MME of 600mg daily, five times higher than the opioid overutilization threshold (120mg daily) in place at the time.  See CMS Ex. 21 at 5; P. Br. at 25.  The MME increased to 1,080mg per day in just three months, nine times higher than CMS’s opioid overutilization threshold.  Dr. Greene’s patient notes for T.M. lacked any justification for a starting MME of five times the overutilization threshold.  Further, Dr. Greene’s notes lacked any information for the rapid increase to nine times higher than the overutilization threshold.  CMS Ex. 11 at 4-22.  Additionally, Dr. Greene’s notes contained no discussion about the prescribing of benzodiazepines, particularly in light of T.M.’s extremely high methadone dose.

On March 10, 2016, T.M. filled prescriptions for alprazolam (Xanax), and 270 pills of methadone HCl 10mg.  CMS Ex. 21 at 5.  By March 27, 2016, T.M. was dead, with the cause listed as blunt force head injuries and “Other Significant Conditions” noted as “Acute methadone and alprazolam intoxication.”  CMS Ex. 11 at 44.  The medical examiner’s report indicated that the circumstances of the death were:  “Found at bottom of stairs; self administered methadone and alprazolam.”  CMS Ex. 11 at 44.

Dr. Sullivan testified that the medical records showed that Petitioner initially prescribed T.M. 600mg MME per day in August 2015 and by March 2016 prescribed 1,080mg

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MME per day, a nearly 80 percent increase within that time.  CMS Ex. 54 ¶ 35; Tr. at 94.  Dr. Humpert testified that during the period when Petitioner was significantly increasing the MME per day for T.M., T.M. noted that his pain was under control and improved to 4-5/10.  CMS Ex. 52 ¶ 50; CMS Ex. 11 at 4.  “Nothing in the record explained why the increase in medication was necessary” and “[t]here was no discussion in the record about tapering T.M.’s medication.”  CMS Ex. 52 ¶ 50.

Both Dr. Sullivan and Dr. Humpert testified that their reviews of T.M.’s medical records showed that Petitioner prescribed alprazolam (Xanax) concurrently with a heavy dose of methadone, thus prescribing opioids and benzodiazepines at the same time.  CMS Ex. 52 ¶ 32; CMS Ex. 54 ¶ 38.  Dr. Humpert indicated that this was problematic without a clear justification due to heightened risk of drug misuse, respiratory depression, and overdose.  CMS Ex. 52 ¶ 36.  Dr. Hirsch’s testimony agrees with Dr. Humpert’s testimony:  “There is no justification given for the selection of alprazolam as a sleeping aid, and the combination with high-dose methadone is potentially inappropriate.”  CMS Ex. 51 ¶ 3.3.1.

Both Dr. Sullivan and Dr. Humpert testified that, based on the toxicology report at the time of T.M.’s death, T.M. had such a high level of methadone as measured in his blood that these high methadone amounts, in conjunction with the prescribed alprazolam (Xanax), contributed to T.M.’s death. CMS Ex. 52 ¶ 32; CMS Ex. 54 ¶¶ 39-40.  Dr. Sullivan clarified that the direct cause of the blunt force trauma was not caused by specific medications in his system.  Tr. 160

In briefing, Petitioner asserts that T.M.’s MME was 600mg in August 2015 when he first went to Petitioner and Petitioner prescribed methadone for him.  However, following a spinal fusion in September 2015, Petitioner increased his prescription to 960mg MME per day.  In October 2015, Petitioner says T.M.’s pain was still not controlled and Petitioner again increased the dosage to 1,080mg MME, an amount he remained on until his death in March 2016.  P. Br. at 25.

Petitioner asserts that T.M. had difficulty sleeping and that diazepam (Valium) was prescribed, but T.M. did not feel well in the morning.  Therefore, Petitioner added alprazolam (Xanax) at bedtime.  P. Br. at 25-26.  Petitioner states that by February 2016, T.M.’s pain was under control, he was cognitively intact, was sleeping better, and his vital signs were monitored.  P. Br. at 26.

Petitioner argues that co-administration of opioids and benzodiazepines is not contraindicated, although Petitioner admits it does present the risk of profound sedation, respiratory depression, coma, and death.  P. Br. at 27.  Further, Petitioner argues that he “slowly” increased the methadone dosage over a three-month period.  P. Br. at 28.  Petitioner also denies that T.M.’s death had anything to do with the medication prescribed for him, pointing out that the toxicology report was consistent with the

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prescribed medications T.M. was taking and that T.M.’s death was due to blunt force trauma.  P. Br. at 28.

I do not need to find that Petitioner’s prescribing practices related to T.M. contributed to his death to find that those practices were a threat to T.M.’s health and safety.  Although, it must be stated that, circumstantially, it appears T.M. fell down his stairs and hit his head hard enough to kill him.  At the time, he was intoxicated by Petitioner’s combination of medications.  It is not unreasonable for the expert witnesses to conclude that the drugs prescribed to T.M. played a role in his death, even if the drugs themselves could not have directly caused the injury to his head.

I do find that T.M. had been in a state of acute methadone and alprazolam (Xanax) intoxication for months based on the prescription records.  Petitioner quickly, not slowly as his brief says, raised the MME per day for T.M. to a level that was extraordinarily high by any measure.  Petitioner had almost doubled a high initial dosage within a few months to get to that level.  But that was not the only risk that Petitioner took – he also added a benzodiazepine.  Although Petitioner’s brief indicates it was all to control pain and allow T.M. to sleep, I accept the expert witness testimony that there is insufficient justification for these prescriptions in the medical notes.  Without proper justification in the records or testimony from Petitioner, I cannot conclude that Petitioner engaged in appropriate prescribing for T.M.

9. Dr. Greene prescribed multiple opioid analgesic controlled substances each month for S.R. from approximately August 2015 through May 2018. Additionally, beginning December 2015, Dr. Greene also prescribed tizanidine HCl, a muscle relaxer for S.R.  In 2016, Petitioner provided prescriptions for two fast-acting opioids as a replacement for the previous long-acting opioid.  In November 2016, Dr. Greene added alprazolam (Xanax).  By 2017, Petitioner was prescribing over 200mg of MME per day, which is in excess of the 90mg/120mg MME per day level at which there is an elevated risk of overdose.  Further, prescribing benzodiazepines and muscle relaxants at the same time as opioids provided further risks to S.R.  Dr. Greene provided insufficient justification in the medical record for these actions.

S.R. initially presented to Dr. Greene’s office in August 2015 with diagnoses including chronic pain syndrome, lumbar radiculopathy, and lumbago.  CMS Ex. 12 at 106.  At the outset, Dr. Greene prescribed S.R. hydromorphone HCl (Dilaudid) 4mg and hydromorphone HCl ER (Exalgo) 8mg, even though medical notes from past providers clearly state:  “narcotics should not be used in this patient with an unclear diagnosis and pain consistent with muscular problems only.”  CMS Ex. 12 at 106, 207.  Over time, Dr. Greene prescribed S.R. high-dose opioids, hydromorphone and hydrocodone; along with a benzodiazepine, alprazolam (Xanax); and a muscle relaxant.  CMS Ex. 21 at 6-9.

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Treatment notes in December 2015, state that S.R.’s pain “is better with the medication,” but also discuss adding an additional pill of hydromorphone (Dilaudid) because S.R.’s pain “is not under control.”  CMS Ex. 12 at 96.  Notes dated August 7, 2017, indicate that a pharmacist called Petitioner’s office about S.R.’s prescriptions, and noted that S.R.’s MME is 210mg, and her benzodiazepines conflict with her opioids.  CMS Ex. 12 at 40.

Notes dated March 14, 2018, reflect a large fluctuation in S.R.’s pain levels, noting her “pain level is 3-4/10 and the high was 10 last week.”  CMS Ex. 12 at 9.  Additionally, Dr. Greene states that S.R.’s “PCP and other Kaiser MDs are continuing to try and find some alternative/adjunctive therapies to reduce her pain so we can wean her medication” but have been unable to find anything yet.  CMS Ex. 12 at 9.

By May 2018, S.R. was prescribed 140 pills of hydrocodone/acetaminophen (Norco) 325mg/10mg; 140 pills of hydromorphone HCl (Dilaudid) 8mg; 56 pills of alprazolam (Xanax) 1mg; and 30 pills tizanidine HCl 4mg, for a total daily MME of 220.9mg.  CMS Ex. 21 at 8-9.  Even at that level of pain management, S.R. still indicated her pain was usually at a 7/10, and nearly every set of medical notes is either copied from the previous visit or contains a request by S.R. for more painkillers.

Dr. Sullivan testified that Petitioner first prescribed S.R. 128mg MME per day and over the course of 2017 increased that to 210mg MME per day.  CMS Ex. 54 ¶ 35; Tr. 92.

Dr. Humpert testified that, in addition to the MME per day of Petitioner’s prescriptions, he had other concerns.  Petitioner prescribed two short-acting opioids (hydromorphone (Dilaudid) 8mg and hydrocodone/acetaminophen (Norco) 10/235mg) to S.R. for almost 18 consecutive months with no indication why those medications needed to be prescribed together.  CMS Ex. 52 ¶ 30.  Dr. Humpert testified that combining two short-acting opioids is not typically utilized because it can increase the risk of abuse, overdose, and drug diversion (i.e., the illegal sale of prescription drugs for non-medical purposes).  CMS Ex. 52 ¶ 29.  Dr. Humpert further testified that Petitioner prescribed S.R. opioids and benzodiazepines at the same time, which heightened the risk for harm, including drug misuse, respiratory depression, and overdose.  CMS Ex. 52 ¶¶ 33, 36.  Dr. Sullivan’s testimony is consistent with Dr. Humpert’s and underscores the dangerous situation that Petitioner created.  CMS Ex. 54 ¶¶ 41-45.

Dr. Humpert also testified that he could not find a justification in S.R.’s medical record for the prescription of tizanidine.  Dr. Humpert further testified that “[c]ombining a muscle relaxant like tizanidine, with a benzodiazepine and an opioid, forms an extremely dangerous combination.  Since all three drugs work to relax muscle tissues and inhibit neurons within the brain . . . users [of these three types of drugs] often stop breathing in their sleep and die from lack of oxygen to the brain.”  CMS Ex. 52 ¶ 39; Tr. 171.  Dr. Humpert suggested that Petitioner “could have used one, rather than two central nervous sedatives.  And he could have used them in smaller amounts in [S.R.].”  Tr. 171.

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Dr. Hirsch’s testimony agrees with Dr. Humpert’s testimony:

There was no documented justification for the tizanidine or alprazolam.  The need for two opioids also was not clearly justified in the notes.  The patient was placed at increased risk of harm from CNS and respiratory depression, psychomotor impairment, hypotension, constipation, and ileus.

CMS Ex. 51 ¶ 3.4.2.

Finally, Dr. Humpert noted that several documented drug screening results showed S.R. was positive for cannabis/marijuana, ecstasy, amphetamines, and oxymorphone.  CMS Ex. 52 ¶¶ 63-64.  Dr. Humpert’s conclusion based on his review of S.R.’s records was that Petitioner’s failure to accurately record information from S.R.’s drug screening results, as well as failing to follow up on the results “threatened patient safety because the patient may have been ingesting multiple non-monitored amounts of different short acting opioids, which can lead to overdose and death.”  CMS Ex. 52 ¶ 64.  Dr. Hirsch’s testimony agreed with Dr. Humpert’s testimony:  “The use of unauthorized opioids placed the patient at risk of harm from overdose and reflected inadequate patient oversight and policy enforcement despite drug screens.”  CMS Ex. 51 ¶ 3.4.2.

In Petitioner’s brief, Petitioner asserts that original efforts to control S.R.’s pain failed with long-acting opioids.  In June 2016, Petitioner changed S.R.’s prescription to two short-acting opioids, which brought relief and which S.R. stayed on for nearly two years.  P. Br. at 22.  Regarding Petitioner’s prescription of a benzodiazepine in conjunction with opioids, Petitioner recognizes the risk that there may be profound sedation, respiratory depression, coma, and death; however, Petitioner argues that the vital signs for S.R. were checked each month and were normal.  P. Br. at 24.

I accept the assessments of the expert witnesses and find that Petitioner’s prescribing practices related to S.R. were a threat to S.R.’s health and safety.  Petitioner escalated S.R. to an MME level significantly higher than the generally safer 90mg/120mg MME per day amount.  In this case, the opioids prescribed were more dangerous because they were two fast-acting opioids.  Add to this, prescriptions for a benzodiazepine and a muscle relaxant, and the risks to S.R. increased further.  Without proper justification in the records or testimony from Petitioner as to these actions, I cannot conclude that Petitioner engaged in appropriate prescribing for S.R.

10. Dr. Greene prescribed multiple opioid analgesic controlled substances each month for R.N. from approximately August 2015 through May 2018.  Petitioner was prescribing 512mg MME per day by the end of 2017, which is an MME level significantly higher than the generally safer 90mg/120mg MME per day amount.  In addition, Petitioner prescribed for R.N. two short-acting opioids at

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1. the same time. Petitioner also prescribed a benzodiazepine (triazolam), while Petitioner was receiving opioids, which increased risks to R.N.  Finally, Petitioner ignored or took no action on positive drug screening results, which is particularly troubling because of R.N.’s history of potential drug abuse.   Greene provided insufficient justification in the medical record for these actions/inactions.

R.N.’s medical record contained a series of medical documents from another pain management center.  CMS Ex. 13 at 158-168.  Part of those records, dated May 21, 2015, state that the pain management physician did not recommend opioids as pain management for R.N.  CMS Ex. 13 at 168.  Additionally, records dated June 20, 2013, indicate that R.N. had previously been to a detox center to “come off of her medications.”  CMS Ex. 13 at 162.  The notes further detail that the practice indicated that it would no longer provide R.N. with short-acting medications for her chronic pain.  CMS Ex. 13 at 163.  On May 29, 2015, R.N. again returned to the pain management clinic.  CMS Ex. 13 at 158.  Notes from that visit clearly state, “it was very apparent that [R.N.’s] primary objective was to obtain Oxycodone prescriptions . . . .”  CMS Ex. 13 at 160.

In August 2015, Dr. Greene first prescribed R.N. opioids.  CMS Ex. 21 at 10.  However, the first notes in the record are dated September 22, 2015, and note that R.N. was “4 days early” for her appointment, but that “she brought her medicine bottle and she is fine.” CMS Ex. 13 at 86.  On December 10, 2015, R.N. had an appointment with Dr. Greene, where she noted that her pain increased since she fell and hit her chest two weeks ago.  CMS Ex. 13 at 78.  The notes state that R.N. went to an urgent care where an X-ray revealed a fractured rib.  CMS Ex. 13 at 78.  Also, on December 10, 2015, R.N. filled a prescription for a 28-day supply of 140 tablets of oxymorphone HCl 10mg.  CMS Ex. 21 at 10.

On December 11, 2015, one day after having filled an entire month’s supply of oxymorphone, R.N. went to another urgent care clinic (with an unrelated provider) complaining of rib pain and requesting pain medication.  CMS Ex. 13 at 169.  Visit notes state:

[R.N.] states she has been having rib pain and the [sic] 11/27/15 was seen in New [J]ersey and states she had xray and has rib fractures.  [R.N.] states she is still having a lot [sic] of pain and does not have any pain rx.

CMS Ex. 13 at 169.

Additionally, R.N. told the urgent care clinic that she had filled a prescription for 90 tablets of hydromorphone (Dilaudid) on November 17, 2015, and another prescription for 75 tablets of oxymorphone on November 23, 2015, but she finished the medication and

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needed more.  CMS Ex. 13 at 169.  R.N. was given enough morphine for 4 days and told to seek pain management.  CMS Ex. 13 at 171.

Medical record notes dated January 4, 2016, and authored by Dr. Greene state that R.N.’s urine test came back positive for “oxymorphone and dilaudid and fentanyl” but noted that it was “ok because she went to the urgent care because her ribs.”  CMS Ex. 13 at 75.  Additionally, Dr. Greene noted that R.N.’s PDMP showed that:

[R.N.] went to another place one day after she came here on DECEMBER 10[,] 2015 and she got 4 days of morphine sulfate but [R.N.] said that is impossible she did not go to other place.  In fact she states that she was on her way to NJ for a wedding.  So we will contact the pharmacy and urgent care where the prescription allegedly originated and attempt to confirm that she was seen and that she was indeed the one who received the prescription.  However, she cites no change in the quality or character or location of her pain.  Therefore, we will not change her meds at time.

CMS Ex. 13 at 75.

Notes from R.N.’s visit with Dr. Greene in February contain no mention of following up on the inconsistent PDMP results from December.  In fact, the notes indicate that R.N.’s PDMP and urine test were reviewed, appropriate, and R.N. “is compliant.”  Dr. Greene then adjusted R.N.’s medication, nearly doubling her daily MME from 310mg to 616mg.  CMS Ex. 13 at 72; CMS Ex. 21 at 10.

Although Dr. Greene continued prescribing opioids for R.N. from March through September 2016, the record lacks medical records or notes for those visits.

On October 31, 2016, R.N. presented two weeks early for her medical appointment, claiming that she was having some issues getting her oxymorphone filled, and was going to be out of town for a week or two.  CMS Ex. 13 at 51.  Notes also indicate that R.N.’s urine test was positive for hydromorphone (Dilaudid), oxymorphone, and tramadol.  CMS Ex. 13 at 51.  Dr. Greene does not mention that R.N. also tested positive for alprazolam (Xanax), a benzodiazepine.  See CMS Ex. 13 at 279-288.  Furthermore, the last time Dr. Greene had prescribed oxymorphone to R.N. was on August 16, 2016.  CMS Ex. 21 at 10.

On January 4, 2017, R.N. again presented a week early for her appointment with Dr. Greene, stating she was headed out of town for two weeks.  CMS Ex. 13 at 45.  Notes indicate that her urine test was “normal” for hydromorphone (Dilaudid), oxycodone (OxyContin), Tapentadol (Nucynta), and morphine, but noted that it was ok because R.N.

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had been “taking this medication before we started on methadone last month.”  CMS Ex. 13 at 45.  The record also indicates that the last time Dr. Greene had prescribed oxycodone (OxyContin) to R.N. was in September 2016.  CMS Ex. 21 at 10.

Notes in March of 2017 repeat the same troubling pattern; R.N.’s preliminary urine test yielded a positive result for methadone as expected, in addition to oxymorphone and oxycodone (OxyContin).  Dr. Greene indicated that he would discuss this with R.N. at the next visit but continued prescribing her medication in the interim.  CMS Ex. 13 at 40, 305-308.  In May, July, and August 2017, Dr. Greene again noted that R.N.’s urine test was positive for non-prescribed opioids.  CMS Ex. 13 at 23, 26, 34.  The record does not reflect that R.N. received any disciplinary action or warnings.

On May 22, 2018, R.N. was prescribed 168 pills of methadone HCl 10mg, and 168 pills of hydromorphone HCl 8mg for a total daily MME of 792mg.  CMS Ex. 21 at 11.

Dr. Sullivan testified that Petitioner first prescribed R.N. 141mg MME per day in 2015 and by the end of 2017, Petitioner’s prescriptions increased to 512mg MME per day.  CMS Ex. 54 ¶ 35.

Based on his review of R.N.’s medical record, Dr. Humpert was concerned by Petitioner’s actions.  He noted that another physician documented that R.N. was “focused on obtaining Oxycodone prescriptions” instead of other treatments.  CMS Ex. 52 ¶ 55.  Dr. Humpert assessed Petitioner’s indifference to this situation as follows:

The report was included as part of the medical records from Dr. Greene’s office, but there is no indication that he discussed it with R.N., nor did Dr. Greene mention that R.N. had been through a detox program in the past, or that she had a history of seeking oxycodone.  All of that would have been important information to determine the potential for abuse and misuse of opioid medication.  Upon seeing that note, any doctor would have obtained a full history on R.N.’s background and records from prior treating physicians.  Instead, just two months after Dr. Kim’s report, Dr. Greene prescribed oxycodone to R.N., which continued for three months.  This was contrary to the standard of care expected from a physician because it heightened the risk that R.N. would misuse her medication.

CMS Ex. 52 ¶ 55 (citations omitted).  Dr. Hirsch’s testimony agrees with Dr. Humpert’s testimony above.  He stated:  “Dr. Greene was acting below the standard of care by ignoring important chart information that should have alerted him to the patient’s potential for opioid abuse and therefore prompted reconsideration of his progressive

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increase in prescribed MME.”  CMS Ex. 51 ¶ 1.1.3.1; see also CMS Ex. 51 ¶ 3.5.3.

Dr. Humpert also noted that in a urinary drug screening, R.N. tested positive for fentanyl, a Schedule II controlled substance that can lead to death if misused.  Petitioner did not have documentation as to why R.N. ought to have this medication; however, despite the fact that this would indicate potential misuse, Petitioner did not address it with R.N. or take further action.  CMS Ex. 52 ¶ 58.  Dr. Humpert noted that Petitioner also failed to act on positive drug screens for tramadol at times when Petitioner had not yet prescribed it to her, and for oxycodone (OxyContin) when Petitioner had not prescribed it to R.N. for months.  CMS Ex. 52 ¶¶ 59-61.  Dr. Sullivan’s testimony was in agreement with Dr. Humpert’s testimony.  CMS Ex. 54 ¶¶ 47-49.

Dr. Humpert testified that Petitioner prescribed two short-acting opioids, hydromorphone (Dilaudid) 8mg and oxymorphone 10mg, for seven consecutive months with no indication why those medications needed to be prescribed together.  CMS Ex. 52 ¶ 30.  Dr. Humpert testified that combining two short-acting opioids is not typically utilized because it can increase the risk of abuse, overdose, and drug diversion (i.e., the illegal sale of prescription drugs for non-medical purposes).  CMS Ex. 52 ¶ 29.

Dr. Humpert further testified that:

Dr. Greene prescribed a benzodiazepine, triazolam, to R.N. “in addition to the Xanax she is taking.”  CMS Ex. 13 at 13.  Prescribing two benzodiazepines at the same time for one patient, especially while she is taking opioid medication, unnecessarily increases risk to the patient and amplifies the depressant effects of the drugs, increasing the risk of respiratory depression, overdose, and death.

CMS Ex. 52 ¶ 35.  Dr. Sullivan’s testimony was consistent with this, commenting that Petitioner prescribed “two very potent opioids” as well as a benzodiazepine and that “[t]hese medications prescribed concurrently substantially increases the risk of patient harm from opioid overdose.”  CMS Ex. 54 ¶ 46.  Dr. Hirsch showed a similar concern:  “There was no justification for two separate benzodiazepines, and their use in addition to high-dose opioids placed the patient at significantly increased risk of CNS depression and was counter to the CDC’s recommendations.”  CMS Ex. 51 ¶ 3.5.4.

In briefing, Petitioner asserts that he acted properly in prescribing two short-acting opioids to control R.N.’s pain, with a prescription change later to a long-acting opioid, and later still to methadone and a short-acting opioid.  Petitioner considered this effort to control R.N.’s pain as simply appropriate prescribing.  P. Br. at 22-23.  Regarding Petitioner’s prescription of a benzodiazepine in conjunction with opioids, Petitioner recognizes the risk that there may be profound sedation, respiratory depression, coma,

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and death; however, Petitioner argues that the vital signs for R.N. were checked each month and were normal.  P. Br. at 24.

Petitioner’s prescriptions to R.N. are more complicated than Petitioner lets on.  I find that Petitioner’s prescribing practices related to R.N. were a threat to R.N.’s health and safety.  Petitioner escalated R.N. to 512mg MME per day by the end of 2017, which is an MME level significantly higher than the generally safer 90mg/120mg MME per day amount.  Further, Petitioner used two short-acting opioids for many months, which increased the risk further.  Petitioner seemed to ignore R.N.’s documented potential for substance abuse and failed to act when R.N. had positive results for drug screenings.  Finally, Petitioner prescribed a benzodiazepine while prescribing opioids, creating additional risk for R.N.  However, Petitioner did not document the reasons for all of these actions/inactions.  Without proper justification in the records or testimony from Petitioner as to these actions, I cannot conclude that Petitioner engaged in appropriate prescribing for R.N., and I accept the assessments of the expert witnesses.

11. Dr. Greene prescribed multiple opioid analgesic controlled substances each month for B.S. from approximately November 2015 through November 2016. Petitioner escalated his dosage of opioid prescriptions and, by the end of 2016, Petitioner’s prescriptions increased to 760mg MME per day, which is an MME level significantly higher than the generally safer 90mg/120mg MME per day amount.  In addition, Petitioner did not take sufficient action on positive drug screening results, which, among other things, indicated alcohol use.  Due to the drugs B.S. was taking and his history of alcoholism, B.S. was in danger when drinking alcohol.  Dr. Greene provided insufficient justification in the medical record for these actions/inactions.

Medical notes from another provider, beginning in 2013, indicate that B.S. had several serious diagnoses, including hypertensive disorder, cardiomyopathy, shoulder impingement syndrome, and a history of cocaine and polysubstance abuse.  CMS Ex. 14 at 128.  Additionally, the records note that B.S. was recently hospitalized with an overdose of Advil and Benadryl.  CMS Ex. 14 at 128.

B.S.’s initial medical records from Dr. Greene indicate a history of alcoholism, but fail to note B.S.’s history of cocaine abuse.  CMS Ex. 14 at 66-67.  Additionally, the notes indicate B.S.’s “preliminary urine test is positive to oxycodone.”  CMS Ex. 14 at 66.  However, the notes neither indicate that the oxycodone (OxyContin) was prescribed by a previous doctor, nor express any concern about prescribing hydromorphone (Dilaudid) along with the already-prescribed oxycodone (OxyContin). 

On December 7, 2015, B.S.’s urine test came back positive for both hydromorphone (Dilaudid) and oxycodone/acetaminophen (Percocet).  CMS Ex. 14 at 60.  B.S. claimed to have not taken oxycodone/acetaminophen (Percocet), so Dr. Greene had him take

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another urine test and follow-up in two weeks.  CMS Ex. 14 at 60.  Two weeks later, B.S. tested negative for Percocet.  CMS Ex. 14 at 57. 

Despite the fact the notes only reflect a prescription for hydromorphone (Dilaudid), medical records dated January 18, 2016, state that B.S.’s “urine test[ed] normal to methadone and Dilaudid.”  CMS Ex. 14 at 54; but see CMS Ex. 21 at 12 (showing methadone prescribed as of December 21, 2015).  In fact, Dr. Greene only entered B.S.’s methadone into his chart on January 18, 2016.  CMS Ex. 14 at 52.

Notes from an April 2016 visit state that B.S. reported “some decreased mental capacity in the form of confusion and some possible hallucinations.”  CMS Ex. 14 at 32.  Dr. Greene advised B.S. to continue the medication, but take the prescriptions at separate times.  CMS Ex. 14 at 32.  Notes from the following visit state that B.S. fell several times.  CMS Ex. 14 at 29.  The record is missing notes from June 2016, but notes from July 2016 state that B.S. fell again and fractured his L1 and L2 vertebrae.  CMS Ex. 14 at 26.  In September 2016, notes indicate that B.S. is suffering from “significant proximal weakness and needs a full workup.”  CMS Ex. 14 at 14.  Additionally, B.S.’s toxicology report from September 2016 is positive for ethyl, an alcohol derivative, and cyclobenzaprine, a muscle relaxant.  CMS Ex. 14 at 197.

Despite the fact that combining alcohol with opioids and benzodiazepines could be potentially fatal or indicate substance misuse, Dr. Greene simply circled the ethanol result on the lab report without even mentioning it in the patient notes.  CMS Ex. 14 at 10-13, 196-197.  Additionally, Dr. Greene merely checked off the cyclobenzaprine result, even though it had not been prescribed to B.S. in about a year.

B.S.’s pill count chart showed one time where he could not produce his prescribed medication, and another instance where the pill count was far below expected.  CMS Ex. 14 at 148-149.  B.S.’s patient notes do not mention either event.  CMS Ex. 14 at 18-19, 32-34.

On December 21, 2015, B.S. was prescribed 56 pills of methadone HCl 10mg, and 112 pills of hydromorphone HCl 8mg, for a daily MME of 208mg.  CMS Ex. 21 at 12.  By November 30, 2016, B.S.’s prescription was 180 pills of methadone HCl 10mg, and 150 pills of hydromorphone HCl 8mg, for a daily MME of 760mg.  CMS Ex. 21 at 12.

Dr. Sullivan testified that Petitioner first prescribed B.S. 64mg MME per day in November 2015 and by December 2016, Petitioner’s prescriptions increased to 760mg MME per day.  CMS Ex. 54 ¶ 35.

Dr. Sullivan and Dr. Humpert testified that Petitioner prescribed opioids and benzodiazepines to B.S. at the same time.  CMS Ex. 52 ¶ 33; CMS Ex. 54 ¶ 50.  Dr. Humpert further testified that Petitioner did not have a clear justification for doing so

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and, both he and Dr. Sullivan thought Petitioner’s actions created a heightened risk of harm, including drug misuse, respiratory depression, and overdose.  CMS Ex. 52 ¶ 35; CMS Ex. 54 ¶¶ 50-51, 54.  Dr. Hirsch’s testimony agreed:  “Besides being on two high-dose opioids for unclear reasons, he was prescribed a nightly benzodiazepine, putting him at increased risk for CNS and respiratory depression and psychomotor impairment, as well as constipation or ileus.”  CMS Ex. 51 ¶ 3.6.1.

Dr. Humpert testified that he was concerned that Petitioner only noted B.S.’s history of alcoholism and occasional alcohol use, “[b]ut went on to prescribe Dilaudid to B.S. without inquiring about his history of substance abuse or discussing the risk of taking alcohol with opioids.”  CMS Ex. 52 ¶ 54; Tr. at 182-183.  The medical records that Petitioner had received about B.S. showed cocaine, alcohol, and polysubstance abuse, including a hospitalization in 2013 for an overdose of two medications.  CMS Ex. 52 ¶ 54.

Further, Dr. Humpert noted that drug screening results during the period that B.S. was under the care of Petitioner showed positive results for oxycodone (OxyContin), even though Petitioner did not prescribe oxycodone (OxyContin) to B.S., and, on another occasion, ethanol, which is indicative of alcohol consumption.  Although Petitioner indicated he would discuss the oxycodone (OxyContin) results with B.S. at the next office visit, there is no record that he did.  Further, there is no documentation that Petitioner discussed “the grave risks of using alcohol and opioids together.”  CMS Ex. 52 ¶¶ 65-66.

Dr. Sullivan agreed with Dr. Humpert that the positive test showing alcohol was significant due to B.S.’s history of alcoholism and “the potential for synergistic effects between opioids and alcohol.”  Further, she agreed that Petitioner failed to adequately follow-up on the drug screening results, which included a positive result for

Other than mentioning that Petitioner checked B.S.’s vital signs each month and that they were normal, Petitioner’s briefing does not appear to discuss B.S.  P. Br. at 24.

I find that Petitioner’s prescribing practices related to B.S. were a threat to B.S.’s health and safety.  Petitioner escalated B.S. to 760mg MME per day by the end of 2016, which is an MME level significantly higher than the generally safer 90mg/120mg MME per day amount.  Further, Petitioner did not take action when B.S. had positive drug screening results, including a positive result to alcohol.  B.S., a patient with a history of alcoholism, was at significant risk of danger if he drank alcohol and took opioids.  Without proper justification in the records or testimony from Petitioner as to these actions/inactions, I cannot conclude that Petitioner engaged in appropriate prescribing for B.S.

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12. Dr. Greene prescribed multiple opioid analgesic controlled substances each month for L.P. from approximately September 2015 through November 2017. Petitioner prescribed 248mg MME per day in September 2015.  In April 2017, Petitioner prescribed 1,080mg MME per day.  By the end of 2017, Petitioner’s prescriptions were at 675mg MME per day.  Each of these levels of MME were significantly higher than the generally safer 90mg/120mg MME per day amount.  On November 7, 2017, L.P. was prescribed 168 pills of methadone HCl 10mg, and 140 pills of oxycodone/acetaminophen (Percocet) 325mg/10mg.  Additionally, on March 31, 2018, Dr. Greene prescribed mirtazapine (Remeron) for L.P.  L.P.’s drug screening produced positive results that Petitioner did not always respond to, and Petitioner permitted L.P. to take benzodiazepines prescribed by another provider even though that increased the risk to L.P.

L.P. presented to Petitioner’s clinic in September 2015, with complaints of shoulder pain, type II diabetes mellitus, and diabetic peripheral neuropathy.  CMS Ex. 15 at 92.  Notes from that visit state “condition poorly-controlled on treatment.”  CMS Ex. 15 at 91.

Medical notes from L.P.’s November 2, 2015 visit state that Dr. Greene reviewed the patient contract with L.P. and cautioned him that “self-escalation of his medication” could be grounds for discharge from the practice.  CMS Ex. 15 at 87.  Additionally, despite notes indicating that L.P.’s condition was “still not controlled optimally,” L.P. had a daily MME of 276.  CMS Ex. 15 at 87; see CMS Ex. 21 at 13.  Notes for L.P.’s November 16, 2015 visit state that L.P. requested an additional pill of hydromorphone (Dilaudid), because he “[t]akes 4 instead of three.”  CMS Ex. 15 at 85.  The notes again indicate that Dr. Greene cautioned L.P. that “self-escalation of his medication” could be grounds for discharge from the practice.  CMS Ex. 15 at 85.

On December 3, 2015, L.P. came in for an appointment two weeks early.  The notes indicate L.P.:

[Had a] fall from the second floor and he was rolling down and he bumped his head, right shoulder, back, right hip and right ankle, his pain has been increase since that time and he has been taken more medication than directed, he only has two pill less from his regular medication and he has to come in next December 14, I explain him that if he has to take more medicine we have to know why and we have to tell him if is ok or not but he did by himself and this is a violation of the contract because he took medicine for one month in two week. . . .  I told him I go to give him one opportunity but he has to come back every week for several week and if he is ran out of the medicine one more time he will be discharge from

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this office, and the patient understood.  I go to prescribe him norco 10/325 every 6 hour and we will see him in one week.

CMS Ex. 15 at 83.

In July 2016, L.P.’s medical records state that he presented to Dr. Greene’s office with complaints of increased pain, because he had been hospitalized without his medication for 3-4 days.  CMS Ex. 15 at 58.  The notes indicate that the physician from the hospital called Dr. Greene and informed him that L.P. was in withdrawal and that he would not receive narcotics at the hospital.  CMS Ex. 15 at 58.

Notes for August 2016 indicate that Dr. Greene authorized increased doses of opioids for L.P., while at the same time, L.P. had serious complaints of inability to eat, anorexia, and increased nausea with the pain.  CMS Ex. 15 at 52.  Dr. Greene added Marinol, an anti-nausea/appetite stimulant to L.P.’s medication regimen.

In October 2016, L.P. reported his pain at a level 10/10, despite a daily MME of 282mg.  CMS Ex. 15 at 42.  Additionally, the notes document that L.P. “has been taking more medication” and coming up short on his medication counts.  CMS Ex. 15 at 42.  Dr. Greene noted that as a result, he discontinued L.P.’s hydromorphone (Dilaudid) and replaced it “with an equivalent amount of methadone + 30% increase to attempt to give him some relief from the severe pain that he has been experiencing.”  CMS Ex. 15 at 42 (emphasis added).  The record lacked any explanation for the jump from a daily MME of 282mg to 1,050mg.  CMS Ex. 21 at 14.

Treatment notes for January 3, 2017, indicate that L.P.’s urine test was missing oxycodone/acetaminophen (Percocet), so L.P. was required to repeat the test.  CMS Ex. 15 at 37.  On January 30, 2017, Dr. Greene noted:

I am not comfortable increasing his percocet as I do not want to increase his acetaminophen intake.  Will d/c the Percocet.  Begin Oxycodone 20 mg qid.  Therefore his oxycodone med is increased 33%.  His other meds remain unaltered.

CMS Ex. 15 at 34.

Notes in April 2017, while L.P. had a daily MME of 1,080mg, state that L.P. would be given a naloxone (Narcan) prescription the following month.  CMS Ex. 15 at 27; CMS Ex. 21 at 14.  L.P. did not present to Dr. Greene’s clinic between April and July of 2017.  Medical records dated July 19, 2017, indicate that L.P.’s urine test was positive to oxycodone and opioids, and his PDMP shows that on July 6, 2017, L.P. received a 7‑day supply of oxycodone/acetaminophen (Percocet) from another provider.  CMS Ex. 15 at 23.  In August 2017, L.P.’s PDMP again showed methadone prescribed by another

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doctor.  CMS Ex. 15 at 20.  Dr. Greene reminded L.P. that he is not allowed to receive medication from another provider again.  CMS Ex. 15 at 20.  In addition, L.P.’s urine test was positive for methadone only, but negative for the prescribed oxycodone/acetaminophen (Percocet).  CMS Ex. 15 at 20; CMS Ex. 21 at 15.

A PDMP report dated September 17, 2017, flagged L.P. as a “suspected prescriber/pharmacy shopper,” and noted that, over the past 3 months, L.P. received controlled substance prescriptions written by 7 different prescribers, and filled at 4 different pharmacies.  CMS Ex. 15 at 156.  In fact, L.P.’s entire PDMP record is filled with duplicative prescriptions.  See CMS Ex. 15 at 141-159.  On July 6, 2017, L.P. filled two prescriptions provided by an unrelated physician; one for a 30-day supply of 60 tablets of Lorazepam 0.5mg, and one for a 7-day supply of 28 tablets of oxycodone/acetaminophen (Percocet) 5mg/325mg.  CMS Ex. 15 at 153.  On July 19, 2017, L.P. filled several prescriptions written by Dr. Greene, including one for a 30-day supply of 90 tablets of Lorazepam 1mg, and one for a 25-day supply of 150 tablets of oxycodone/acetaminophen (Percocet) 10mg/325mg.  CMS Ex. 21 at 14-15.

On January 30, 2017, Petitioner issued a Formal Letter of Counseling to L.P. because L.P. ran out of prescribed medications early and then took more than was prescribed.  CMS Ex. 15 at 100.  Notes dated November 16, 2017, state that L.P. called Dr. Greene’s office and was told that if he did not come in for his appointment, “it may be grounds for discharge.”  CMS Ex. 15 at 9.  In a November 21, 2017 letter, Petitioner discharged L.P. as his patient based on a failure to comply with a required pill count.  CMS Ex. 15 at 97.

Dr. Sullivan testified that Petitioner first prescribed L.P. 248mg MME per day in September 2015 and by the end of 2017, Petitioner’s prescriptions increased to 675mg MME per day.  CMS Ex. 54 ¶ 35.  Dr. Sullivan testified that Petitioner prescribed methadone for L.P. in November 2017.  Tr. 80.  Dr. Sullivan testified that terminating a patient is consistent with the patient care agreement and appropriate patient management.  Tr. 97.

Dr. Humpert was concerned that Petitioner did not adequately document the reasons supporting the prescribing choices he made for L.P.  He stated:

For example, in response to L.P.’s reports of severe pain, Dr. Greene discontinued Dilaudid and replaced it “with an equivalent amount of methadone – 30% increase” for pain relief.  CMS Ex. 15 at 46.  Dr. Greene did not convert the opioids based on their reference to morphine, as is standard practice when changing opioids.  Instead, he replaced 180 tablets of hydromorphone 8mg with 240 tablets of methadone 10mg.  Id. at 182, 185.  This increased L.P.’s MED overnight from 282mg/day to 1,050mg/day.  This large increase put

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L.P. at risk of abuse, and overdose.  Even after a five-fold increase in pain medication for months, L.P. did not experience documented improvement in pain levels.  Id. at 40; CMS Ex. 21 at 14.  See also, e.g., CMS Ex. 15 at 120-140.

CMS Ex. 52 ¶ 49.

Dr. Humpert also testified that Petitioner prescribed opioids and benzodiazepines at the same time.  CMS Ex. 52 ¶ 33.  In addition, Dr. Humpert’s review of L.P.’s medical record showed that another physician prescribed benzodiazepines for L.P. while Petitioner was prescribing opioids; however, Petitioner failed to document this in L.P.’s medication list.  CMS Ex. 52 ¶ 34.  Dr. Humpert testified that Petitioner did not have a clear justification for prescribing this combination of drugs; therefore, his actions created a heightened risk of harm, including drug misuse, respiratory depression, and overdose.  CMS Ex. 52 ¶ 35.

Dr. Humpert also testified in detail that Petitioner had not taken appropriate action when L.P.’s drug screenings showed positive results for drugs that Petitioner had not prescribed for L.P.  CMS Ex. 52 ¶¶ 67-71.

Other than mentioning that Petitioner checked L.P.’s vital signs each month and that they were normal, Petitioner’s briefing does not appear to discuss L.P.  P. Br. at 24.

Based on the evidence of record, I find that Dr. Greene threatened L.P.’s health and safety by prescribing L.P. with extremely high-dose opioids, with the knowledge that L.P. was already prescribed benzodiazepines by another prescriber.  Further, Petitioner did not take appropriate action when drug screening returned positive results.  Although Petitioner eventually terminated L.P. as a patient, this was after inaction on Petitioner’s part.  While I find that Dr. Greene occasionally noted that L.P. was receiving opioids from other sources, he did not properly monitor or discipline L.P.

13. Other relevant information provided to CMS strongly supports revocation of Petitioner’s Medicare enrollment for improper prescribing practices under the factor at 42 C.F.R. § 424.535(a)(14)(i)(H) because the evidence shows that Petitioner placed beneficiaries at risk for addiction and death based on prescribing high doses of opioids, prescribing benzodiazepines and/or muscle relaxants concurrently with opioids, prescribing two fast-acting opioids at the same time, and failing to maintain medical records with sufficient justification for such prescriptions.

I have discussed in detail each of the seven Medicare beneficiaries that MEDIC identified as examples of Petitioner’s troubling prescribing practices.  Based on the record evidence

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and expert testimony related to each of the beneficiaries, I found that Petitioner’s actions were a threat to those beneficiaries’ health and safety.  There is no doubt that CMS has easily met its burden to show prima facie evidence that Petitioner’s actions were such a threat.  It is important to note that Petitioner provided the medical records for the beneficiaries.  However, CMS has provided expert testimony to explain why those records show Petitioner’s prescribing practices are problematic and risky.  Petitioner did not put forward expert testimony or his own testimony to refute CMS’s expert witnesses.

In determining that this general factor (i.e., other relevant evidence under 42 C.F.R. § 424.535(a)(14)(i)(H)) is relevant to a revocation for prescribing practices that are improper, I consider the overall assessments of the expert witnesses.

Dr. Sullivan completed her written testimony as follows:

60. Dr. Greene routinely prescribed high dosages of opioids which are linked to substantially higher risks of patient harm. This occurred in all seven of the medical record review beneficiaries above. The amounts prescribed at the end of the medical record review period were up to nine times higher than the threshold amount that CMS uses to identify over-utilizers of opioids (120 MME/day prior to 2018), and twelve times higher than the CDC’s threshold (90 MME/day) for a markedly increased opioid overdose risk.  Dr. Greene often prescribed the highest possible opioid dosage strength for drugs prescribed and substantially escalated the overall dosages in six of the seven beneficiaries reviewed in medical records over the time period reviewed.  In several beneficiaries reviewed, the daily MME was doubled or tripled over the time period reviewed.  In one beneficiary, B.S., the opioid daily dose was increased almost 12-fold by Dr. Greene in the 13-month review time period for medical records. CMS Ex. 21 at 12.

61. A pattern of practice was noted in the PDE record review and medical record review for Dr. Greene of co-prescribing opioids with other CNS depressant drugs which increase the risk of opioid overdose. Of note, 29.1% of all the beneficiaries with medications authorized by Dr. Greene were prescribed both opioids and benzodiazepines, a high-risk practice noted by the CDC opioid treatment guidelines to increase the risk of patient overdoses. CMS Ex. 16 at 7.

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62. An additional pattern of practice evident in both the PDE record review and medical record review was the prescribing by Dr. Greene of duplicative opioid analgesics. While it is common to prescribe both a long-acting and short-acting opioid concurrently, Dr. Greene was noted to prescribe multiple short-acting opioids concurrently and frequently. This practice is duplicative, and can be harmful to patients, as short-acting opioids typically have less abuse deterrent properties than long-acting opioid agonists. In addition, the prescribing of duplicative opioids can be an attempt by either the prescriber and/or beneficiary to avoid quantity limit edits on specific opioid drugs meant to decrease opioid overutilization by Medicare plans.

63. In the medical record review, Dr. Greene was noted in multiple beneficiaries to have inconsistent [urinary drug screening] reports where no action was taken and/or results were not further clarified. Failing to ensure appropriate use of high dose opioids in beneficiaries is not consistent with prudent pain management practices and does not show that Dr. Greene is monitoring these patients in a manner commensurate with the risks of therapies he is prescribing.

CMS Ex. 54 ¶¶ 60-63 (emphasis added).  The other experts agree with Dr. Sullivan’s concerns.  Dr. Humpert was particularly concerned at the high dosages of opioids that Petitioner provided to his patients without documenting the medical necessity.  He testified:

18. In reviewing the medical records for seven beneficiaries, it is clear that Dr. Greene prescribed all seven of the beneficiaries excessive doses of opioid controlled substances with limited or no documentation of medical necessity. Dr. Greene eventually prescribed all seven of the beneficiaries a morphine equivalent dose (“MED”) greater than 200 mg/day, well above a threshold that should cause concern.

* * * * *

24. It is unusual for a physician to prescribe MEDs of opioids at the levels Dr. Greene prescribed where the patients involved were not terminally ill or had a cancer diagnosis.

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Each beneficiary reported having pain and diagnoses for which some level of opioid analgesics may have been appropriate.  However, the supporting medical documentation failed to establish medical need for the high doses of controlled substances.  Dr. Greene argued in his reconsideration request that, with appropriate dosage titration, there is no maximum dose of opioids.  CMS Ex. 1 at 3-4.  There is no indication that Dr. Greene appropriately titrated doses during his course of treatment.  Further, Dr. Greene’s manner of prescribing ignored the risk of harm from the potential for misuse, respiratory depression, overdose, and death that comes from unjustified prescription of high-dosage opioids and other drugs.

CMS Ex. 52 ¶¶ 18, 24.

Dr. Humpert also was concerned by other risky prescribing practices such as prescribing more than one short-acting opioid at a time, prescribing opioids concurrently with benzodiazepines, and prescribing opioids with muscle relaxants.  CMS Ex. 52 ¶¶ 27, 31, 37.  Dr. Humpert further explained that Petitioner’s medical records lacked adequate medical documentation because they failed to have detailed plans of care for each beneficiary and relied too heavily on each patient’s subject pain score.  CMS Ex. 52 ¶¶ 47, 48.  Finally, Dr. Humpert concluded that Petitioner had failed to address evidence that his patients may be engaged in substance abuse or opioid misuse.  CMS Ex. 52 ¶ 47.

Dr. Hirsch’s testimony was generally in agreement with Dr. Humpert’s testimony.  Dr. Hirsch added that absent from Petitioner’s records were “plans to taper opioids or reduce dependence on opioids by adding other non-opioid medications or modalities.”  CMS Ex. 51 ¶ 1.1.2.  Dr. Hirsch also noted that Petitioner’s medical records largely omit treatment goals other than providing better pain relief, and functional/cognitive status generally remained unchanged throughout the record of the patients.  CMS Ex. 51 ¶¶ 1.2, 1.3.  Finally, Dr. Hirsch gave the following assessment as to whether Petitioner’s medical records provide adequate justification for the prescriptions and dosages provided to the patients:

There was no documentation of attempts to understand the physiological or psychological basis for the patients’ symptoms and to address those issues prior to adjusting the opioid therapy.  The rationale for the dosages used are not discussed except in the context of lack of effectiveness.  There is no documentation for choice of opioid beyond ineffectiveness of the current one.

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CMS Ex. 51 ¶ 2.1.

At the hearing, Dr. Hirsch testified as to his concerns about Petitioner’s prescription practices.  He stated that the seven patients reviewed had chronic pain, which makes them extremely complex patients requiring a person with great expertise.  Tr. 223.  Dr. Hirsch testified that opioids are part of pain management for chronic pain and that there is no set maximum MME for chronic pain; however, he explained that the longer one takes opioids the more one is sensitive to pain, which he called opioid induced hypersensitivity.  Tr. at 224-225.  As a result, individuals may need more opioids to counteract the pain, but “[y]ou also want to make sure that you’re not subjecting that individual to increased risk as you go up and up and up on the morphine equivalents of that medication.  So a general goal is you want to find a dose that is the lowest possible dose.  Sometimes you actually have to reduce the dose of opioid in order to get it working again. . . .  Yes, sometimes you have to go up, but at some point you’ve got to bite the bullet, help - - and slowly taper the medication, slowly taper the pain medication so that you’re - - you’re trying to counteract that opioid induced hypersensitivity.”  Tr. 226-227; see Tr. 285, 295.

Dr. Hirsch further testified that:  “So in none of Dr. Greene’s patients did the morphine equivalent dosages go down over the course of - - of his treatment of them.  Nor was there any discussion of how do we get this dose down?  That’s an integral part of pain management.”  Tr. 227.  Dr. Hirsch also noted that Dr. Greene’s documentation indicated that his patients’ functional status remained the same throughout the time he treated them.  Tr. 228.  Dr. Hirsch testified that if Petitioner’s documentation provided a more adequate explanation for what he was doing, the MME levels for the patients may have been appropriate; however, Dr. Hirsch stated that “documenting . . . is everything” and it is the only tool for understanding how the pain is being managed in a person.  Tr. 229.

Dr. Hirsch acknowledged that most of Petitioner’s patients already had fairly high levels of MME when they started with him, and that these were complicated patients.  Tr. 231.  However, he said that just dispensing medications to them is insufficient.  Tr. 231.  Dr. Hirsch thought that Petitioner’s prescriptions were inappropriate because the patients were already beginning to reach the ceiling for the MME where the medications were no longer safe, and one cannot just continue to indefinitely increase doses.  Tr. 278.  Further, because the patients were complex, Dr. Hirsch would have expected to see comprehensive assessments by Petitioner.  Tr. 271.  Dr. Hirsch explained that if Petitioner did not acknowledge in his notes that he considered various information, such as from the PDMP, then there is no way to know that he did.  Tr. 232-233.  And Dr. Hirsch noted that there were instances where Petitioner prescribed higher dose opioids even when the patients were in violation of their contract with Petitioner (i.e., taking medications from other sources), which means Dr. Greene was giving the patient a break, or overlooked the PDMP or a drug screening result.  Tr. 233.  Dr. Hirsch indicated that it is important to specifically consider whether the patients are engaging in inappropriate drug-seeking behavior.  Tr. 235.

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The experts’ testimony, based on the review of the medical records for the seven beneficiaries, provides a myriad of problems with Petitioner’s prescribing practices that are relevant to the determination as to whether Petitioner should be revoked under 42 C.F.R. § 424.535(a)(14)(i).  These concerns and problems significantly supported the revocation.

Prescription of Excess Dosages Linked to Patient Overdoses

14. Dr. Greene prescribed two high-dose opioids and a benzodiazepine to his patient, P.H. P.H. filled those prescriptions on August 11, 2016.  On August 12, 2016, P.H. suffered an overdose.  Under Dr. Greene’s care, P.H. was prescribed medications in excess of the maximum MME of 90mg per day that the CDC identified as being at an elevated risk level for an overdose.

According to Medicare program records, Petitioner prescribed the following to beneficiary P.H.:  a 30-day supply (120 tablets) of hydromorphone HCl, an opioid with a 64mg MME per day; a 30-day supply (60 tablets) of oxycodone (OxyContin), an opioid with a 90mg MME per day; and a 30-day supply (60 tablets) of diazepam (Valium), a benzodiazepine.  CMS Ex. 18 at 1.  P.H. had these prescriptions filled on August 11, 2016.  CMS Ex. 18 at 1.

Also, according to Medicare program records, on August 12, 2016, P.H. went to a hospital emergency room.  The principal diagnosis was “poisoning by other opioids, accidental (unintentional).”  CMS Ex. 18 at 2.

Dr. Sullivan reviewed the Medicare records and testified as follows about the drugs that Petitioner had prescribed for P.H. and the MME level concerning those drugs:

In the period prior to P.H.’s overdose, Dr. Greene authorized prescriptions for oxycodone [Extended Release] (brand name: Oxycontin) and hydromorphone.  Hydromorphone, while dispensed as a generic, is commonly known by its respective brand name, Dilaudid.  Beneficiary P.H. received the brand name drug Oxycontin.  Oxycodone, like hydromorphone, is a Schedule II controlled substance.  Oxycodone is also an opioid analgesic used to relieve pain . . . .  Besides relieving pain, both oxycodone and hydromorphone depress the respiratory system.  The dose dependent effect of opioids on the respiratory system is significantly linked to the risk of opioid overdoses as discussed previously.  In Beneficiary P.H., the opioid dosage at the time of her overdose was 154 MME/day, well above both the amount the CDC identified as being an elevated risk for overdose (90 MME) and the 120

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MME/day threshold that CMS used in 2016 to evaluate potential opioid overutilization in beneficiaries.

CMS Ex. 54 ¶ 32.  Dr. Sullivan also testified P.H. had only received opioids based on Petitioner’s prescriptions.

A review of PDE records indicated that P.H. had not received any other opioids from Medicare prescribers other than Dr. Greene in the time period encompassing her opioid overdose.  Therefore, Dr. Greene was the only known source of opioids for P.H.

CMS Ex. 54 ¶ 33; see CMS Ex. 7 at 5.

In this proceeding, Dr. Sullivan testified that taking opioids and benzodiazepines “increase risk of overdose significantly.”  Tr. 87; CMS Ex. 54 ¶ 61.

15. From April 28, 2017 to May 18, 2017, Dr. Greene prescribed two high-dose opioids, benzodiazepines, a muscle relaxant, and an antidepressant to L.R. On May 23, 2017, L.R. suffered an overdose.  Under Dr. Greene’s care, L.R. was prescribed medications in excess of the maximum MME of 90mg per day that the CDC has identified as being at an elevated risk level for an overdose.

According to Medicare program records, Petitioner prescribed the following to beneficiary L.R.:  a 30-day supply (90 tablets) of hydromorphone HCl, an opioid with a 192mg MME per day; a 30-day supply (90 tablets) of Morphine Sulfate, an opioid with a 180mg MME per day; a 30-day supply (60 tablets) of diazepam (Valium), a benzodiazepine; a 30-day supply (90 tablets) of Gabapentin; and a 30-day supply (30 tablets) of Sertraline HCl .  CMS Ex. 18 at 3.  L.R. had these prescriptions filled Between April 28, 2017, and May 18, 2017.  CMS Ex. 18 at 3.

Also, according to Medicare program records, on May 23, 2017, L.R. went to a hospital emergency room.  The principal diagnoses were Sepsis, “Poisoning by other opioids, undetermined, initial encounter,” “Poisoning by antiallergic and antiemetic drugs, undetermined, initial encounter.”  CMS Ex. 18 at 4-10.

Dr. Sullivan reviewed the Medicare records and testified as follows about the drugs that Petitioner had prescribed for L.R. and the MME level concerning those drugs:

In the 30 days prior to L.R.’s overdose, Dr. Greene had prescribed for her two Schedule II opioids, hydromorphone 8 mg and morphine sulfate Extended Release (ER) 60 mg.  CMS Ex. 18 at 3; CMS Ex. 21 at 19. . . .  L.R.’s opioid

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dosage at the time of her overdose was 372 MME/day, over four times the amount the CDC identified as being an elevated risk for opioid overdose, and three times above CMS’ overutilization MME threshold in 2017.

Dr. Greene also prescribed diazepam 10 mg, gabapentin 800 mg, and sertraline 25 mg to L.R, which were dispensed prior to the opioid overdose and encompassed the overdose timeframe.  CMS Ex. 18 at 3. . . .  Diazepam is a benzodiazepine.  Opioids concurrently prescribed with a benzodiazepine increase the risk of respiratory depression and opioid overdoses. . . .

Gabapentin is also a CNS depressant and can increase the risk of overdose in patients prescribed concurrent opioids.  Sertraline is a type of antidepressant known as a selective serotonin reuptake inhibitor (“SSRI”).  Although sertraline does not cause CNS depression, it can, in combination with opioids, increase the risk of serotonin syndrome, which is a potentially life-threatening condition. . . .  High dosages of either opioids or the SSRI could potentially increase the already known risk of serotonin syndrome in a patient who receives both concurrently.  It is noteworthy that Beneficiary L.R. had an opioid overdose code unrelated to opioids in addition to their opioid overdose, which indicates that [] other drugs such as gabapentin or sertraline were potentially related to the overdose events.

The Medicare Part B records indicate that L.R. was treated in the emergency room, then admitted to the hospital with multiple diagnoses, including poisoning by other opioids.  CMS Ex. 18 at 4-10.  PDE records indicate that L.R. had not received any other opioids from any other prescribers in the Medicare Part D drug data prior to her opioid overdose.  Therefore, the only known source

CMS Ex. 54 ¶¶ 26-29.

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16. The record contains evidence that Dr. Greene prescribed opioids and benzodiazepines in excessive dosages to P.H. and L.R. and those excessive dosages were linked to P.H. and L.R.’s overdose events. Therefore, the factor at 42 C.F.R. § 424.535(a)(14)(i)(C) provides support for CMS’s determination to revoke Petitioner’s Medicare enrollment for improper prescribing practices.

The third factor listed in § 424.535(a)(14)(i)(C) is whether the physician prescribed controlled substances in excessive dosages that are linked to patient overdoses.

Petitioner asserts that he did not prescribe controlled substances in excessive dosages that were linked to patient overdoses.  P. Br. at 10.  In arguing that, Petitioner contests the meaning of the term “excessive”, arguing that “[t]here was no indication that CMS deemed a MED greater than 120 mg/day to be ‘excessive’.”  P. Br. at 10.  However, as already found above, at the time of both overdose incidents, the CDC had already concluded that that risk for overdose increased over an MME of 90mg per day.

Petitioner argues that the overdose analysis for P.H. is flawed and unreliable because the documentation relied on initially contained two different Health Insurance Claim Numbers (HICNs) for P.H.  Petitioner notes:

While CMS had Dr. Sullivan file a supplemental declaration in an attempt to explain how P.H. had two HICNs, it is respectfully submitted that it did not resolve the issue.  Doubt still exists as whether the P.H. whose Part B information was provided was, in fact, the same patient whose information was provided under Part D.

P. Br. at 14.

Petitioner notes that L.R. was admitted to the hospital with an altered mental status, a principal diagnosis of “sepsis, unspecified organism,” a secondary diagnosis of “poisoning by other opioids, undetermined, initial encounter” and a third diagnosis of “poisoning by antiallergic and antiemetic drugs, undetermined, initial encounter.”  P. Br. at 16; see CMS Ex. 18 at 4, 6-7.  Petitioner argues that “L.R. was clearly an unhealthy person,” and that Petitioner had previously increased L.R.’s pain medication to combat pain due to a worsening prosthesis infection.  Petitioner contends that:

Patient L.R. may have been so ill from the sepsis and other health conditions that she was disoriented and took her medication incorrectly.  Such an occurrence is distinctly possible given the fact that she was listed as having a diagnosis code for “altered mental status, unspecified.”  If

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that occurred, L.R.’s “overdose” would not be linked to Petitioner Greene excessively prescribing opioids to L.R.  It would be the result of the patient incorrectly taking her medication and was not related to the level of MMEs of her prescriptions.

P. Br. at 17.

Petitioner further argues that the only indicator of an overdose in P.H. and L.R.’s files are diagnoses noting “[p]oisoning by other opioids, accidental (unintentional), initial encounter.”  P. Br. at 15-16; see CMS Ex. 18 at 2, 4.  Petitioner states that without the medical records from the facilities “one can make a finding that [P.H. and L.R.] “overdosed” in connection with Petitioner Greene’s prescriptions only by leaping to that conclusion.”  P. Br. at 15, 17.  Petitioner argues that there is no indication as to what medication P.H. and L.R. overdosed on, since the descriptor for both simply states, “other opioid.”  Petitioner opines that it may not have been one of the drugs prescribed by Petitioner, and P.H. or L.R. may have “obtained an opioid-based drug from another source (e.g., a friend, a family member, a drug dealer).”  P. Br. at 16.  Finally, Petitioner notes that the records for both P.H. and L.R. were “barebones” and lacked toxicology or lab reports verifying an overdose event.  P. Br. at 15.

CMS argues that under the regulation, it must show that Petitioner’s prescriptions for excessive dosages of controlled substances are “linked” to overdoses, but that CMS is not required to definitively prove that the prescriptions “caused the overdoses.”  CMS Br. at 7.

Regarding the documentation relied on by CMS, Dr. Sullivan provided a supplemental declaration as to the creation of CMS Exhibits 8, 18, and 21.  CMS Ex. A ¶¶ 3-8.  Further, Dr. Sullivan explained in the supplemental declaration how MEDIC searched for records to be used in relation to P.H. to ensure that P.H.’s use of multiple HICNs did not affect the accuracy of the information obtained from Medicare databases.  CMS Ex. A ¶ 9.  Petitioner had the opportunity to cross-examine Dr. Sullivan as to her supplemental declaration but did not do so.

I conclude that, based on Dr. Sullivan’s testimony, the data provided by MEDIC is sufficiently reliable and that, consequently, it is appropriate to have considered it when deciding this case.

I also conclude that CMS has provided prima facie evidence, as summarized above, that Petitioner’s prescribed controlled substances for P.H. and L.R. were in excessive dosages and linked to patient overdose.  42 C.F.R. § 424.535(a)(14)(i)(C).  Petitioner did not sufficiently rebut CMS’s case.

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Pattern or Practice of Prescribing that is Abusive or Represents a Threat to Health and Safety

17. CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(14)(i).

The ultimate question is whether CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment because he has a pattern or practice of prescribing Medicare Part D drugs that is abusive or represents a threat to the health and safety of Medicare beneficiaries, or both.  42 C.F.R. § 424.535(a)(14)(i).  Based on four of the eight factors to consider in the regulations, CMS had a basis to conclude such a pattern or practice exists.  The situations with all 9 beneficiaries discussed above makes it clear that Petitioner’s prescribing patterns are a threat to the health and safety of beneficiaries.  Petitioner represented that same threat before his license in Virginia was suspended.  Shortly after resuming his practice in Virginia, Petitioner returned to his previous conduct.  Based on the record, Petitioner has spent much of his career as a physician prescribing opioids in a risky manner.  Revocation in this case is necessary.

VI.  Conclusion

I affirm CMS’s revocation of Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(14)(i).

1. Although I will use MME in this decision, quotations from the record may use MED instead.  MME and MED are essentially synonymous.  CMS Ex. 54 at 4 n.1; see CMS Ex. 52 ¶ 19.  Therefore, the mixed use of those terms in this decision is not intended to convey any distinction between those terms.
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2. “A PDMP . . . refers to a state’s electronic prescription drug monitoring program, which is used to support healthcare providers and their patients in the safe and effective use of prescription drugs.”  CMS Ex. 52 at 6 n.3.
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3. The PDMP often reflects gaps in months between the time that prescriptions were written and T.G. filled those prescriptions.  CMS Ex. 9 at 94-96.  Therefore, without additional records, it is unclear what the true MME for T.G. was before being treated by Petitioner.
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