Fares J. Rabadi, MD, DAB CR6247 (2023)

DECISION

The Centers for Medicare & Medicaid Services (CMS) upheld a determination by Noridian Healthcare Solutions (Noridian), a Medicare administrative contractor, revoking the Medicare enrollment and billing privileges of Petitioner, Fares J. Rabadi, MD, pursuant to 42 C.F.R. § 424.535(a)(13) based on the Drug Enforcement Administration’s (DEA’s) issuance of an order revoking Petitioner’s Certificate of Registration.¹  CMS also upheld the imposition of a five-year bar to reenrollment and the inclusion of Petitioner on its Preclusion List.  Because CMS had a legal basis for its determinations, I affirm CMS’s determinations.

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I.   Background and Procedural History

Petitioner, a physician, was enrolled in the Medicare program in California.  CMS Ex. 9 at 1.  On March 2, 2020, the then-Acting DEA Administrator issued an “Order to Show Cause and Immediate Suspension of the Registration” of Petitioner.  CMS Ex. 1.  The order “immediately suspended [Petitioner’s] DEA Certificate of Registration Number . . . ‘because [his] continued registration constitutes an “imminent danger to the public health or safety.”’”  CMS Ex. 1 at 1.  The order “also proposed revocation of [Petitioner’s] registration, the denial of any pending applications for renewal or modification of such registration, and the denial of any pending applications for additional DEA registrations pursuant to 21 U.S.C. [§§] 824(a)(4) and 823(f), because [Petitioner’s] ‘continued registration is inconsistent with the public interest.’”  CMS Ex. 1 at 1.  

Following a DEA administrative law judge (ALJ) hearing in September 2020, a DEA ALJ issued a recommended decision, to include recommended rulings, findings of fact, and conclusions of law, on December 22, 2020.  CMS Ex. 1 at 1.  The recommended decision summarized the allegations raised against Petitioner in the Order to Show Cause and Immediate Suspension of Registration, explaining:

The Government alleges [Petitioner] regularly prescribed highly addictive and intoxicating combinations of controlled substances to his patients, and that he consistently failed to:  (1) Perform adequate physical evaluations and obtain appropriate patient histories; (2) make appropriate diagnoses based on sufficient clinical evidence and document these diagnoses in his medical records; (3) document a legitimate medical purpose for the controlled substances that he prescribed; (4) monitor his patients’ medication compliance; and (5) respond to red flags of drug abuse and diversion.  These failures constitute extreme departures from the standard of care in California, and that his actions were dangerous and reckless.  Because of these failures, he regularly put his patients at significant risk for harm, including overdose or death.  He also continued to prescribe controlled substances to these patients despite the fact that he knew they were suffering from opioid dependencies.  [The OSC went on to provide specific examples of [Petitioner’s] alleged failures related to seven individuals: S.B., M.B., B.C.,

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J.C., D.D., J.M., and K.S. ALJX 1, at 14.][²]  For each of the seven patients, he continued to prescribe opioids to them, even while noting that each patient suffered from an opioid dependency.  

CMS Ex. 1 at 1.  After reviewing the evidence and testimony, the ALJ determined the Government met its burden of proof and had established its prima facie case, stating: 

Based upon my review of each of the allegations brought by the Government, it is necessary to determine if it has met its prima facie burden of proving the requirements for a sanction pursuant to 21 U.S.C. [§] 824(a)(4).  At the outset, I find that the Government has demonstrated and met its burden of proof in support of its allegations relating to the prescribing of controlled substances to patients S.B., M.B., B.C., J.C., D.D., J.M., and K.S.

CMS Ex. 1 at 42.

The Administrator published an order in the May 19, 2022 edition of the Federal Register that revoked Petitioner’s Certificate of Registration, effective June 21, 2022.  CMS Ex. 1; see also Fares Jeries Rabadi, M.D.: Decision and Order,87 Fed. Reg. 30564 (May 19, 2022).  I highlight an excerpt below from the 45-page Federal Register notice that addresses “Egregiousness and Deterrence”:

[The Agency also looks to the egregiousness and extent of the misconduct, which are significant factors in determining the appropriate sanction. Garrett Howard Smith, M.D., 83 FR at 18910 (collecting cases).]  I find that the proven misconduct is egregious and that deterrence considerations weigh in favor of revocation.  In addition to the myriad of prescribing events falling below the California standard of care, the proven misconduct involved being directly aware of two patients’ apparent abuse or diversion of controlled substances, and being an apparent party to one of those patient’s abuse or diversion.  [Petitioner] treated opioid abuse with hydrocodone which is not a legitimate medical purpose for prescribing

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hydrocodone and is outside the usual course of professional practice, therefore it was an illegal action under state regulations.  Beyond that, his actions unnecessarily exposed his patients to dangerous levels of medication and to dangerous combinations of those medications . . . .

[In sanction determinations, the Agency has historically considered its interest in deterring similar acts, both with respect to the respondent in a particular case and the community of registrants . . . . I find that considerations of both specific and general deterrence weigh in favor of revocation in this case.]  Allowing the [Petitioner] to retain his [Certificate of Registration] despite the proven misconduct would send the wrong message to the regulated community.  Imposing a sanction less than revocation would create the impression that registrants can maintain DEA registration despite ongoing treatment below the California standard of care, knowledge and acquiescence of the abuse or diversion demonstrated herein, the repeated prescribing of dangerous combinations of medications, and the wholesale failure to maintain complete and accurate medical charts. Revoking the [Petitioner’s] [Certificate of Registration] communicates to registrants that DEA takes all failings under the CSA seriously and that severe violations will result in severe sanctions.

[There is simply no evidence that [Petitioner’s] behavior is not likely to recur in the future such that I can entrust him with a CSA registration; in other words, the factors weigh in favor of revocation as a sanction.] 

CMS Ex. 1 at 45. 

On September 29, 2020, the Medical Board of California (Medical Board) issued an “Accusation” charging three causes for discipline involving Petitioner’s care of two patients.  CMS Ex. 6 at 13-19.  The first cause of discipline, “Gross Negligence,” was based on Petitioner’s continued prescribing to patients with opioid dependence, failure to document elements of treatment, and long-term prescribing of narcotics and benzodiazepines that was “an extreme departure from the standard of care.”  CMS Ex. 6 at 16-18.  The second cause of action, “Repeated Negligent Acts,” involved Petitioner’s “care and treatment” of two patients.  CMS Ex. 6 at 18.  The third cause of action,  “Inadequate Records,” was based on Petitioner’s failure “to maintain adequate records of the medical services that he provided” to two patients.  CMS Ex. 6 at 18.

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The Medical Board issued a Stipulated Settlement and Disciplinary Order on August 31, 2021.  CMS Ex. 6.  Petitioner “agree[d] that, at a hearing, [the Medical Board] could establish a factual basis for the charges in the Accusation, and [Petitioner] . . . g[ave] up his right to contest those charges.”  CMS Ex. 6 at 4.  Petitioner further agreed “that his Physician’s and Surgeon’s certificate is subject to discipline and he agree[d] to be bound by the Board’s probationary terms as set forth in the Disciplinary Order.”  CMS Ex. 6 at 4.  The Medical Board revoked Petitioner’s Physician’s and Surgeon’s Certificate, but stayed the revocation and placed him on probation for two years.  CMS Ex. 6 at 5.  The terms of probation included, among other requirements, that Petitioner take courses in prescribing practices and medical record keeping.  CMS Ex. 6 at 5-6.

On June 15, 2022, several weeks after the DEA Administrator published her order in the Federal Register, Noridian informed Petitioner that it was revoking his Medicare privileges, effective July 15, 2022, pursuant to 42 C.F.R. § 424.535(a)(13).  CMS Ex. 2 at 1.  Noridian also informed Petitioner that it had imposed a five-year bar to reenrollment, and that Petitioner would be included on CMS’s Preclusion List pursuant to 42 C.F.R. §§ 422.2, 422.222, 423.100, and 423.120(c)(6).  CMS Ex. 2 at 1, 3.

Petitioner submitted a request for reconsideration dated July 14, 2022.  CMS Ex. 3 at 2.  Petitioner reported that he had appealed the revocation of his DEA Certificate of Registration, was not planning to prescribe controlled medications again, and would be  unable to practice medicine because Medicare patients comprise 60-to-70 percent of his practice.  CMS Ex. 3 at 2. 

CMS, through its Provider Enrollment and Oversight Group, issued a reconsidered determination on September 20, 2022, in which it upheld the revocation of Petitioner’s Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(13), the imposition of a five-year bar to reenrollment, and his placement on the Preclusion List.  CMS Ex. 8.  In upholding Petitioner’s revocation, CMS explained, in pertinent part:

[T]he facts underlying the revocation of [Petitioner’s] DEA [Certificate of Registration] fully support the revocation of his Medicare enrollment.  In the DEA’s March 2, 2020 initial Order to Show Cause and Immediate Suspension of Revocation, there was a preliminary finding that there was an imminent danger to the public health or safety that justified suspending [Petitioner’s] [Certificate of Registration] during the pendency of the revocation proceedings.  The DEA alleged that [Petitioner] regularly prescribed highly addictive and intoxicating combinations of controlled substances to seven of his patients as recently as December 31, 2019.  Specifically, the DEA alleged that [Petitioner] consistently failed to:  (1) perform adequate physical evaluations and

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obtain appropriate patient histories; (2) make appropriate diagnosis based on sufficient clinical evidence and document these diagnoses in his medical records; (3) document a legitimate purpose for the controlled substance he prescribed; (4) monitor his patients’ medication compliance; and (5) respond to red flags of drug abuse and diversion.  Because of these failures, [Petitioner] put his patients at significant risk for harm, including overdose or death.  For each of the seven patients at issue, [Petitioner] continued to prescribe opioids to them even though he was aware that each patient suffered from an opioid dependency.  Following a hearing, and after reviewing the arguments from [Petitioner] and the DEA, an Administrative Law Judge found that [Petitioner] engaged in improper prescribing of controlled substances and that his continued registration to prescribe controlled substances was inconsistent with the public interest.  As a result, on May 19, 2022, [Petitioner’s] [Certificate of Registration] was revoked . . . .  

CMS Ex. 8 at 3.  Addressing Petitioner’s arguments in his reconsideration request, CMS responded that “[Petitioner’s] claims do not negate the fact that the DEA revoked [Petitioner’s] [Certificate of Revocation].”  CMS Ex. 8 at 3. 

CMS also determined that, pursuant to the factors outlined at 42 C.F.R. §§ 422.2 and 423.100, Petitioner should be placed on the Preclusion List.  CMS Ex. 8 at 3-5.  CMS explained that the first two factors set forth in 42 C.F.R. §§ 422.2 and 423.100 were met, as Petitioner’s enrollment had been revoked and a five-year reenrollment bar had been imposed.  CMS Ex. 8 at 4.  CMS also determined that the third factor was met because the underlying conduct that led to Petitioner’s revocation was detrimental to the best interests of the Medicare program.  CMS Ex. 8 at 4-5; see also 42 C.F.R. §§ 422.2 and 423.100.  In its discussion, CMS considered the relevant subfactors, to include addressing the seriousness of the conduct underlying the conviction, the degree Petitioner’s conduct could affect the integrity of the Medicare program, and other evidence that it deemed relevant.  CMS Ex. 8 at 4-5.  In that discussion, CMS noted that the Medical Board determined Petitioner “excessively prescribed, furnished, dispensed, and administered controlled substances” and that the particular drugs that constituted 95 percent of the controlled substances prescriptions prescribed by Petitioner were a “highly dangerous and diverted cocktail commonly known among drug seekers as the ‘Holy Trinity.’”  CMS Ex. 8 at 4-5.  Finally, CMS noted that the Preclusion List had been implemented pursuant to a congressional mandate to “establish a program to prevent prescription drug abuse by Medicare beneficiaries under Medicare Parts C and D.”  CMS Ex. 8 at 5.

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Petitioner filed a request for hearing on October 6, 2022.³  CMS filed a combined brief and motion for summary judgment (CMS Br.), along with 10 proposed exhibits (CMS Exs. 1-10).  Petitioner, through counsel, submitted a pre-hearing brief in opposition to the motion for summary judgment (P. Br.) and two proposed exhibits (P. Exs. 1-2).  In the absence of any pending objections,⁴ I admit CMS Exs. 1-10 and P. Exs. 1-2 into the evidentiary record.

Petitioner submitted his own written direct testimony (P. Ex. 2).  Although CMS appears to request cross-examination of Petitioner,⁵ cross-examination of this witness would serve no useful purpose and CMS is not prejudiced by not having an opportunity to cross-examine Petitioner.⁶  Nor is Petitioner prejudiced by not having its witness subjected to

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cross-examination.  See Five Star Healthcare, LLC, DAB No. 3089 at 8 (2023)(When an ALJ “ruled it unnecessary for CMS to cross-examine Petitioner’s witness and upheld CMS’s revocation determination based on the written record . . . Petitioner suffered no prejudice by the ALJ not permitting cross-examination of its own witness by CMS.”).  The only disputed question that I may review is whether CMS had a legitimate basis, when it exercised its discretion pursuant to 42 C.F.R. §§ 422.2 and 423.100, to uphold Petitioner’s placement on the Preclusion List.  Because CMS considered all relevant regulatory factors, it had a legitimate basis for its determination.  Inasmuch as 42 C.F.R. § 422.2 and 423.100 require CMS to consider the underlying conduct that was the basis for Petitioner’s revocation (i.e., the conduct cited by the DEA Administrator as the basis for revoking Petitioner’s Certificate of Registration), the underlying conduct is a factual matter established by the order.  For purposes of 42 C.F.R. §§ 422.2 and 423.100, the DEA Administrator’s order establishes the underlying conduct that was the basis for the revocation of his enrollment and Petitioner cannot simply refute it solely through testimony.  

A hearing is therefore unnecessary for the purpose of cross-examination of any witnesses.  Pre-Hearing Order §§ 12-14.  I issue this decision on the merits.⁷ 

II.   Issues

Whether CMS had a legitimate basis to uphold the revocation of Petitioner’s Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(13) and impose a five-year bar to reenrollment.

Whether CMS had a legitimate basis to uphold Petitioner’s placement on its Preclusion List.

III.   Jurisdiction

I have jurisdiction to decide these issues.  42 C.F.R. §§ 498.1(g), 498.3(b)(17)(i) and (20), 498.5(l)(2); see also 42 U.S.C. § 1395cc(j)(8).

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IV.   Findings of Fact, Conclusions of Law, and Analysis⁸

As a physician, Petitioner is a supplier of health care services for purposes of the Medicare program.  42 U.S.C. § 1395x(d); 42 C.F.R. §§ 400.202 (supplier), 410.20(b)(1).  In order to participate in the Medicare program as a supplier, an individual must meet certain criteria to enroll and receive billing privileges.  42 C.F.R. §§ 424.505, 424.510.  CMS may revoke a supplier’s enrollment for any reason stated in, inter alia, 42 C.F.R. § 424.535(a).  A supplier’s Medicare enrollment can be revoked as set forth in 42 C.F.R. § 424.535(a)(13): 

(13)  Prescribing authority.

(i) A physician or other eligible professional’s Drug Enforcement Administration (DEA) Certificate of Registration to dispense a controlled substance is currently suspended or revoked or is surrendered in response to an order to show cause.

(ii) The applicable licensing or administrative body for any state in which the physician or eligible professional practices suspends or revokes the physician or eligible professional’s ability to prescribe drugs. 

CMS is authorized to impose a bar to reenrollment for a minimum of one year, but no more than ten years.  42 C.F.R. § 424.535(c)(1)(i). 

Additionally, CMS has established a single list of providers and prescribers who are precluded from being reimbursed for Medicare Advantage items or services or Part D drugs they furnish or prescribe to Medicare beneficiaries.  42 C.F.R. §§ 422.222, 423.120(c)(6).  As relevant here, CMS may place an individual, entity, or prescriber on its Preclusion List under the following circumstances:  

(i)  The [individual, entity, or prescriber] is currently revoked from Medicare for a reason other than that stated in § 424.535(a)(3) of this chapter.
(ii)  The individual or entity is currently under a reenrollment bar under § 424.535(c).
(iii)  CMS determines that the underlying conduct that led to the revocation is detrimental to the best interests of

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the Medicare program.  In making this determination under this paragraph 1(iii), CMS considers the following factors:  

(A) The seriousness of the conduct underlying the individual’s or entity’s revocation.
(B) The degree to which the individual’s or entity’s conduct could affect the integrity of the Medicare program.
(C) Any other evidence that CMS deems relevant to its determination. 

42 C.F.R. §§ 422.2 (Preclusion List), 423.100 (Preclusion List). 

1. On December 22, 2020, a DEA ALJ issued a recommended decision to revoke Petitioner’s DEA Certificate of Registration.
2. On May 19, 2022, the DEA Administrator published an order in the Federal Register in which she revoked Petitioner’s Certificate of Registration.
3. On August 31, 2021, the Medical Board of California issued a stipulated settlement and disciplinary order that revoked Petitioner’s Physician’s and Surgeon’s Certificate, but stayed the revocation and placed him on probation for two years.
4. Petitioner does not dispute that CMS was authorized to revoke his Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(13).
5. Petitioner does not dispute that CMS was authorized to impose a five-year bar to reenrollment pursuant to 42 C.F.R. § 424.535(c), and I may not review CMS’s exercise of its discretion with respect to the length of a reenrollment bar.
6. CMS had a legitimate basis to uphold the revocation of Petitioner’s enrollment application pursuant to 42 C.F.R. § 424.535(a)(13) because the DEA had revoked his Certificate of Registration.
7. Petitioner’s sole dispute raised in his briefing is whether his conduct is detrimental to the Medicare program such that he should not be included on the Preclusion List. 

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8. CMS had a legitimate basis to uphold Petitioner’s placement on its Preclusion List pursuant to 42 C.F.R. §§ 422.2, 423.100, based on its determinations that Petitioner’s Medicare enrollment had been revoked, he was under an active reenrollment bar, and the conduct underlying his revocation was detrimental to the Medicare program.

Petitioner does not dispute that CMS was authorized to revoke his Medicare enrollment; CMS had a legitimate basis to uphold the revocation of Petitioner’s Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(13).  

Petitioner concedes that the DEA revoked his Certificate of Registration.  P. Br. at 2.  Petitioner does not offer any argument that CMS was not authorized to revoke his Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(13).  P. Br.  

The Departmental Appeals Board (DAB) has explained that “[t]he ALJ’s . . . role in an appeal of CMS’s . . . revocation of enrollment in the Medicare program is to determine whether CMS had a legal basis for its action,” and “[i]f it did, then [the ALJ is] bound to affirm the . . . revocation.”  Dr. Robert Kanowitz, DAB No. 2942 at 4 (2019).  The DAB has further explained that “the right to review of CMS’s determination by an ALJ serves to determine whether CMS had the authority to revoke [the petitioner’s] Medicare billing privileges, not to substitute the ALJ’s discretion about whether to revoke.”  Letantia Bussell, M.D., DAB No. 2196 at 13 (2008) (emphasis omitted).  As such, the scope of my review is whether CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment. 

Pursuant to 42 C.F.R. § 424.535(a)(13), CMS may revoke the enrollment of a supplier whose DEA Certificate of Registration has been revoked.  Because the Administrator revoked Petitioner’s DEA Certificate of Registration, CMS was authorized to revoke his Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(13).  See CMS Ex. 1.  To the extent Petitioner disagrees with the Administrator’s order and has filed an appeal (P. Ex. 1), the evidence demonstrates that CMS had a legitimate basis to revoke Petitioner’s enrollment.  Regardless of Petitioner’s disagreements, the Administrator’s order became effective on June 21, 2022. 

Petitioner does not dispute that CMS was authorized to impose a five-year bar to reenrollment; CMS had a legitimate basis to impose a five-year bar to reenrollment, and I am not authorized to review CMS’s exercise of its discretion with respect to the length of a reenrollment bar. 

Pursuant to 42 C.F.R. § 424.535(c), CMS is authorized to impose a bar to reenrollment of up to ten years when it has revoked a supplier’s enrollment.  In its reconsidered determination, CMS upheld the five-year bar to reenrollment.  CMS Ex. 8 at 5.  The DAB

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has unambiguously explained that such a matter is beyond the scope of an ALJ’s review, stating:  

A decision by CMS or its contractor about how long to bar a revoked supplier from re-enrolling in Medicare, unlike the determination to revoke the supplier’s billing privileges, is not an appealable “initial determination” under 42 C.F.R. Part 498.  Blossomwood Medical, P.C., et al., DAB No. 2914 at 11 (2018); Vijendra Dave, M.D. [DAB No. 2672] at 8-11 (stating that the authority of an ALJ or the Board in a revocation appeal “does not extend to reviewing the length of the reenrollment bar imposed by CMS”).  We therefore cannot consider or act upon Petitioner’s contention that the three-year re-enrollment bar was excessive in her circumstances.  

Linda Silva, P.A., DAB No. 2966 at 11 (2019).  Petitioner has not identified any legal error in CMS’s imposition of the reenrollment bar, and I may not otherwise review the duration of the reenrollment bar.  See Vijendra Dave, M.D., DAB No. 2672at 11 (2016) (“CMS’s determination regarding the duration of the re-enrollment bar is not reviewable.”). 

CMS had a legitimate basis to uphold Petitioner’s inclusion on its Preclusion List. 

Petitioner disputes his inclusion on CMS’s Preclusion List.  P. Br. at 6 (Conclusion section, arguing that “[t]he record does not support the CMS’s findings that the conduct undertaken by [Petitioner] that led to the revocation was detrimental to the best interests of the Medicare program.”). 

Based on its consideration of the regulatory factors set forth in 42 C.F.R. §§ 422.2 and 423.100, CMS had a legitimate basis to uphold Petitioner’s placement on the Preclusion List.  In assessing a placement on the Preclusion List pursuant to 42 C.F.R. §§ 422.2 and 423.100, CMS is required to consider, in the case of a revoked supplier who is under a reenrollment bar, whether the underlying conduct that led to the revocation is detrimental to the best interests of the Medicare program, based on its consideration of enumerated subfactors.  It did.  CMS’s reconsidered determination demonstrates that it considered all required factors at 42 C.F.R. §§ 422.2 and 423.100, and I do not question CMS’s exercise of its discretion.  See, e.g., Abdul Razzaque Ahmed, M.D., DAB No. 2261 at 19 (2009), aff’d, Ahmed v. Sebelius, 710 F. Supp. 2nd 167 (D. Mass. 2010) (addressing the role of an ALJ in the context of reviewing CMS’s exercise of its discretion and not substituting his or her discretion when CMS had established the necessary regulatory elements).  Even if I could exercise discretion in place of CMS, which I cannot, the evidence amply supports Petitioner’s “egregious” prescription of dangerous levels of medications and combinations of medications to patients.  Petitioner’s behavior is precisely what Congress

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sought to thwart when it enacted the legislation that led to CMS’s implementation of the Preclusion List.⁹  CMS Ex. 1 at 45; CMS Ex. 6 at 4, 16-18 (addressing Petitioner’s conceded gross negligence in the prescribing of controlled substances that was “an extreme departure from the standard of care.”). 

In its reconsidered determination, CMS provided extensive support for its determination that Petitioner would be placed on its Preclusion List, stating:

Regarding the first and second factors, [Petitioner] is currently revoked from the Medicare program effective July 15, 2022, pursuant to [section] 424.535(a)(13).  [Petitioner] is also subject to a re-enrollment bar under [section] 424.535(c), for five years, effective 30 days from the date of the June 15, 2022 letter.  Both the revocation and re-enrollment bar are upheld by this decision.

Regarding the third factor, CMS must determine whether the conduct that led to the revocation is detrimental to the best interests of the Medicare program.  In making this determination, CMS considers the following:

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(A) The seriousness of the conduct underlying the individual’s or entity’s revocation;
(B) The degree to which the individual’s or entity’s conduct could affect the integrity of the Medicare program; and
(C) Any other evidence that CMS deems relevant to its determination.

Regarding factor (A), the revocation of [Petitioner’s] DEA [Certificate of Registration] led to the revocation of his Medicare enrollment pursuant to § 424.535(a)(13).  CMS considers the loss of a DEA [Certificate of Registration] for prescribing, ordering, and/or delegating the prescribing or ordering of, any substances listed in Schedules I-V, to be very serious in nature.  Furthermore, the revocation of a DEA [Certificate of Registration] is a clear indicator to CMS that the physician or eligible professional may be misusing or abusing their authority to prescribe such substances.  Therefore, CMS finds [Petitioner’s] inappropriate prescribing of controlled substances to be a very serious threat to the health, well-being, and safety of Medicare beneficiaries.

Regarding factor (B), [Petitioner’s] DEA [Certificate of Registration] was revoked because he issued numerous prescriptions for Schedule II through IV controlled substances outside the usual course of professional practice and not for a legitimate purpose to seven individuals as recently as December 31, 2019 . . . CMS finds that [Petitioner’s] actions demonstrate a propensity for dangerous and non-compliant behavior, as well as a complete disregard for state and federal government rules and regulations.  Furthermore, [Petitioner’s] actions also call into question his ability to be a trustworthy Medicare partner.  CMS is responsible for protecting Medicare beneficiaries and the Medicare Trust Funds, and the integrity of the Medicare program is dependent on the reliability, integrity, and good judgment of its partners.  Therefore, [Petitioner’s] participation in the Medicare program would negatively affect the integrity of the Medicare program.

Regarding factor (C), CMS finds it relevant that Medical Board of California revoked [Petitioner’s] medical license effective September 30, 2021 . . . . Although the revocation of

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his medical license was stayed, [Petitioner] was still placed on probation for two years.  The Medical Board of California found that [Petitioner] excessively prescribed, furnished, dispensed, and administered controlled substances.  Three drugs (hydrocodone acetaminophen, alprazolam, and carisoprodol) constituted 95% of the controlled substance prescriptions that [Petitioner] issued between November 20, 2015 and November 21, 2018 . . . . In combination, these three drugs make up a highly dangerous and diverted cocktail commonly known among drug seekers as the “Holy Trinity[.]”  The CMS Preclusion List was established to conform with a Congressional mandate.  This mandate intended to establish a program to prevent prescription drug abuse by Medicare beneficiaries under Medicare Parts C and D.  While [Petitioner] is a Medicare provider and not a Medicare beneficiary, the dangerous prescribing by [Petitioner] that led to the revocation of his DEA [Certificate of Registration] is precisely the type of conduct that the CMS Preclusion List was intended to deter within the Medicare program.  In creating the CMS Preclusion List, CMS noted that, “the inclusion of problematic prescribers on the [P]reclusion [L]ist could reduce the amount of opioids that are improperly or unnecessarily prescribed by persons who pose a heightened risk to the Part D program and Medicare beneficiaries.”  82 Fed. Reg. 56,336, 56,444 (November 28, 2017).  The Medicare program is at serious risk if we allow suppliers like [Petitioner] to engage in improper prescribing practices while seeking to prevent and prohibit prescription drug abuse by its beneficiaries.

[Petitioner] makes various arguments as to why he should not be placed on the CMS Preclusion List, including that a majority of his practice includes Medicare beneficiaries and that he will refrain from prescribing controlled substances.  However, these arguments do not negate the fact that CMS finds [Petitioner’s] conduct that led to the revocation of his Medicare enrollment is detrimental to the best interest of the Medicare program and forms an appropriate basis to include him on the CMS Preclusion List.  Therefore, CMS upholds the determination to include [Petitioner] on the CMS Preclusion List, effective the date of this decision.

CMS Ex. 8 at 4-5.

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Petitioner had not argued that CMS failed to consider any regulatory factor when it exercised its discretion and upheld his placement on the Preclusion List.  P. Br.  Rather, Petitioner’s arguments distill to a claim that he did not commit the misconduct outlined in the DEA Administrator’s order revoking his Certificate of Registration.¹⁰  P. Br. at 4-6.  However, Petitioner points to no authority that requires CMS to adjudicate, in the first instance, whether the DEA Administrator’s order was erroneous.  Rather, pursuant to 42 C.F.R. §§ 422.2 and 423.100, CMS evaluates “the conduct underlying the revocation,” which was the prescribing practices that led to the revocation of his Certificate of Registration.  CMS considered this conduct, which was detailed in a lengthy order by the DEA Administrator, and acted within its discretion to uphold Petitioner’s inclusion on its Preclusion List.  See CMS Ex. 1.

V.   Conclusion

I affirm the revocation of Petitioner’s Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(13) and inclusion on CMS’s Preclusion List.

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Endnotes

¹ “Every person who manufactures, distributes, dispenses, imports, or exports any controlled substance or who proposes to engage in the manufacture, distribution, dispensing, importation, or exportation of any controlled substances shall obtain a registration unless exempted by law . . . .” 21 C.F.R. § 1301.11(a).

² In her May 19, 2022 order, the DEA Administrator explained that she added additional language that is included within brackets.  See CMS Ex. 1 at 1 (Administrator’s footnoted discussion of her substantive revisions and “minor, nonsubstantive, and grammatical changes . . . .”).

³ On November 2, 2022, Petitioner requested a “temporary stay” of his enrollment revocation pending the outcome of his appeal of the DEA Administrator’s order.  I am unaware of any authority authorizing me to “stay” a CMS determination.  In an order dated November 3, 2022, I denied Petitioner’s request for a stay but informed the parties that I would expedite the issuance of a decision.  Although I explained that I intended to issue this decision within “several weeks” of the closing of the record, unforeseen circumstances unfortunately delayed the issuance of this decision by several weeks.  While I regret such a delay, I nonetheless note that Petitioner’s request for hearing was adjudicated fewer than five months after the filing of the request for hearing.

⁴ CMS objected to Petitioner’s noncompliant submission of evidentiary exhibits.  Thereafter, Petitioner re-filed its pre-hearing exchange.

⁵ CMS did not submit a compliant request for cross-examination as required by section 13 my standing pre-hearing order.  Rather, CMS stated in its objections that, “[i]n the event [Petitioner] is allowed to testify and CMS’s Motion for Summary Judgment is not granted, CMS requests to cross-examine [Petitioner].”

⁶ In his testimony, Petitioner conceded that the DEA Administrator had revoked his Certificate of Registration.  P. Ex. 2 at 2.  Petitioner also argued that “the DEA overlooked and failed to consider . . . that [he] was able to, and did, monitor the patients for both the efficacy of the prescribed medications and their safe use on a regular and frequent basis over the course of several years.”  P. Ex. 2 at 3.  Petitioner argued that he had “not engaged in conduct that is detrimental to the best interests of the Medicare program, and revocation of [his] DEA [Certificate of Registration] was not warranted. P. Ex. 2 at 4.  Thus, Petitioner’s testimony is merely a denial of the DEA Administrator’s findings.  Compare P. Ex. 2 with CMS Ex. 1.  It is noteworthy that Petitioner failed to acknowledge his stipulation that the Medical Board of California “could establish a factual basis for the charges in the Accusation” that included “Gross Negligence” in his prescribing of controlled substances that “was an extreme departure from the standard of care,” “Repeated Negligent Acts” in the care and treatment of patients, and maintaining “Inadequate Records.”  CMS Ex. 6 at 4, 16-18.

⁷ Because an in-person hearing is unnecessary, I need not rule on CMS’s motion for summary judgment.

⁸ My findings of fact and conclusions of law are in bold and italics.

⁹ On July 22, 2016, the Comprehensive Addiction and Recovery Act of 2016 (CARA) was enacted, and its stated purpose was to “authorize the Attorney General and Secretary of Health and Human Services to award grants to address the prescription opioid abuse and heroin use crisis, and for other purposes.”  Pub. L. No. 114-198, 130 Stat. 695 (2016).  Section 704 of the CARA called on the Secretary of the Department of Health and Human Services (Secretary) to establish a program to prevent prescription drug abuse under Medicare Parts C and D.  Id. at 742-52.  Among other things, Section 704 amended the Social Security Act (42 U.S.C. § 1395w-10(c)) to require the Secretary to implement a drug management program to limit access to controlled substances for at-risk Medicare beneficiaries.  Id. at 742-48.  Section 704(g) of the CARA directed the Secretary to promulgate regulations implementing the provisions of that section of the act.  Id. at 751-52.  Section 704(g)(1) directed that “amendments made by this section shall apply to prescription drug plans . . . for plan years beginning on or after July 1, 2019.”  Id. at 751.  Additionally, Section 704(b)(2) of the CARA specifically amended the Social Security Act, at 42 U.S.C. § 1395w-104(c), to add a provision for a “utilization management tool to prevent drug abuse,” and required that the Secretary conduct a “[r]etrospective utilization review to identify . . . providers of services or suppliers that may facilitate the abuse or diversion of frequently abused drugs by beneficiaries.”  Id. at 748.  CMS proposed rulemaking to implement the CARA on November 28, 2017.  82 Fed. Reg. 56,336.  Consistent with the CARA’s mandate, the final rule established a Preclusion list, effective January 1, 2019.  83 Fed. Reg. 16,440 (Apr. 16, 2018).

¹⁰ I note that Petitioner did not dispute the misconduct that was the subject of the Medical Board’s order and was cited by CMS in its discussion of why Petitioner’s conduct was detrimental to the Medicare program.  CMS Ex. 8 at 4-5.