Salman M. Akbar, M.D., DAB No. 3227 (2026)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Salman M. Akbar, M.D. (Petitioner) appeals the administrative law judge decision in Salman M. Akbar, MD, DAB CR6485 (ALJ Decision).  The ALJ upheld a determination by the Centers for Medicare & Medicaid Services (CMS) to revoke Petitioner’s Medicare enrollment under 42 C.F.R. § 424.535(a)(13)(i) based on the revocation of Petitioner’s Certificate of Registration by the Drug Enforcement Administration (DEA).  The ALJ also declined to review the length of Petitioner’s five-year reenrollment bar and upheld CMS’s determination to place Petitioner on the preclusion list.  We affirm the ALJ Decision for the reasons explained below.

Legal Background

To participate in Medicare, health care providers and suppliers must be enrolled in the program.  42 C.F.R. § 424.500.  A physician, such as Petitioner, is considered a “supplier.”  Id. § 400.202 (defining “Supplier”).  Enrollment confers “billing privileges,” that is, the right to claim and receive payment for health care services provided to Medicare beneficiaries.  Id. §§ 424.502, 424.505.  CMS regulations in 42 C.F.R. Part 424, Subpart P establish requirements for enrolling in Medicare and for securing and maintaining enrollment in the program.

CMS may revoke a supplier’s Medicare enrollment for any of the reasons listed in 42 C.F.R. § 424.535(a).1  Under section 424.535(a)(13), CMS may revoke a physician’s Medicare enrollment if their “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.”  Id. § 424.535(a)(13)(i).

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If CMS revokes a supplier’s Medicare enrollment, the supplier is “barred from participating in the Medicare program from the effective date of the revocation until the end of the reenrollment bar.”  Id. § 424.535(c)(1).  Revocations, with some exceptions not applicable here, become effective 30 days after CMS or the CMS contractor mails notice of the revocation to the supplier.  Id. § 424.535(g).  At the time of the revocation in this case, CMS regulations set the reenrollment bar for a period between one and ten years, depending on the severity of the basis for the revocation.  Id. § 424.535(c)(1)(i).

Effective January 1, 2019, CMS implemented a “preclusion list” applicable to the Medicare Advantage (MA) program (Part C) and Voluntary Medicare Prescription Drug Benefit program (Part D) as part of its effort to “prevent fraud, waste, and abuse, and to protect Medicare enrollees.”  See 82 Fed. Reg. 56,336, 56,448 (Nov. 28, 2017); 83 Fed. Reg. 16,440, 16,643 (Apr. 16, 2018).  In describing the need for the preclusion list, CMS referenced the “nationwide opioid crisis” and noted that “the inclusion of problematic prescribers on the preclusion list 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. at 56,444.  An individual on the preclusion list is prohibited from receiving reimbursement for health care items, services, or drugs provided under Medicare Part C (42 C.F.R. § 422.222) and from receiving reimbursement for drugs prescribed under Medicare Part D (42 C.F.R. § 423.120(c)(6)).  

CMS may place an individual2  on the preclusion list when that individual is currently revoked from Medicare for reasons other than that stated in 42 C.F.R. § 424.535(a)(3) (i.e., certain felony convictions), the individual is under a reenrollment bar, and CMS determines that the conduct that led to the revocation is detrimental to the best interests of the Medicare program.  42 C.F.R. §§ 422.2 (Part C), 423.100 (Part D).3   In determining whether conduct is detrimental, CMS considers the seriousness of the conduct underlying the revocation, the degree to which that conduct could affect the integrity of the Medicare program, and any other evidence that CMS deems relevant.  Id.  CMS has discretion not to include a particular individual on (or if warranted, remove the individual from) the preclusion list if CMS determines that “exceptional circumstances” exist regarding beneficiary access to Part C (MA) items, services, or drugs, or Part D prescriptions.  Id. §§ 422.222(a)(6), 423.120(c)(6)(vi). 

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supplier may appeal a revocation determination and placement on the preclusion list in accordance with the administrative appeal procedures in 42 C.F.R. Part 498.  42 C.F.R. §§ 422.222(a)(2)(i), 423.120(c)(6)(v)(A), 424.545(a).  CMS’s decision to revoke a supplier’s Medicare enrollment and place the supplier on the preclusion list is an “initial determination” under Part 498.  Id. §§ 498.3(b)(17), (20).  The supplier must first request “reconsideration” of the initial determination and, if dissatisfied with the reconsidered determination, may request a hearing before an ALJ.  Id. §§ 498.5(1), 498.5(n), 498.22, 498.40.  A party dissatisfied with an ALJ’s decision may request Board review of the ALJ decision.  Id. §§ 498.5(1)(3), 498.5(n)(3), 498.80.

Case Background

A.        Petitioner’s DEA Certificate of Registration was revoked following an investigation and hearing concerning his opioid prescription practices.

Petitioner is a physician licensed to practice medicine in Virginia.  On March 2, 2020, following an undercover operation, the DEA issued an order to show cause suspending Petitioner’s Certificate of Registration (DEA Certificate) based on evidence that Petitioner had improperly prescribed controlled substances, including opioids, to an undercover officer.  CMS Ex. 8, at 1, 4-6.4  The order informed Petitioner of the immediate suspension of his DEA Certificate and proposed that it be revoked on grounds that Petitioner’s “continued registration is inconsistent with the public interest.”  Id. at 1.  Petitioner requested a hearing on the proposed revocation of his DEA Certificate.  Id.  

On August 20, 2020, following a hearing, a DEA administrative law judge issued recommended findings of fact, conclusions of law, and a decision, recommending that Petitioner’s DEA Certificate be revoked and any pending renewal application be denied.  Id. at 1, 16.  The DEA’s Administrator adopted the recommended decision (with minor modifications), noting that Petitioner “did not unequivocally accept responsibility for his misconduct, and that his registration is inconsistent with the public interest.”  Id. at 1-3.  On September 20, 2021, the DEA issued a final decision revoking Petitioner’s DEA Certificate effective October 20, 2021.  Id. at 1. 

The decision revoking Petitioner’s DEA Certificate reveals that an undercover DEA officer went to Petitioner’s practice, representing himself as a construction worker in need of a new doctor to fill prescription pain medications.  Id. at 4-5.  On four occasions, and without conducting a physical examination or obtaining medical records, Petitioner provided the undercover officer with prescriptions for tramadol, an opioid, to treat back pain.  Id. at 5-6.  Petitioner prescribed the drugs even after the “patient” admitted to

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acquiring diverted drugs, taking oxycodone for a couple years, and being unable to “just stop.”  Id. at 5.  On three occasions, Petitioner also prescribed Ativan, a controlled benzodiazepine medication, based on the undercover officer’s comment that it helps him feel better and relax in the evening.  Id. at 5-6.  During the third visit, Petitioner increased the tramadol prescription despite the “patient” reporting that he felt “pretty good” and not having requested an increase.  Id. at 6.  An expert witness testified, among other things, that none of the prescriptions detailed in the government’s case “were issued for a legitimate medical purpose in the normal course of a professional practice.”  Id. at 8. 

The DEA Administrator found that Petitioner failed to demonstrate “an unequivocal acceptance of responsibility” and “a demonstrable plan of action to avoid similar conduct in the future.”  Id. at 14-15.  Despite being confronted with “progress notes written in his own hand detailing the results of examinations that he never administered,” Petitioner’s testimony reflected his continued belief “that he has never issued a controlled substance prescription that was not legitimate and not within the usual course of a professional practice.”  Id. at 15.  The DEA decision summarized the egregiousness of Petitioner’s conduct as follows:

[Petitioner] did virtually nothing to satisfy (or even further) his responsibilities as a DEA registrant on four occasions.  He had no basis for a valid diagnosis, he had no prior medical records, called no prior treating physician, had no imaging, conducted no examination to speak of, doctored up phony examination results, ignored evidence that the prescriptions were not being filled by his purported patient, disregarded the gaps where the patient would have been without the medicine he was prescribing (even if it had been dispensed and taken as directed), and actually increased the dosage for no articulated reason beyond the fuzzy concept that he had an increased level of ‘comfort[]’ (based apparently on little more than the [officer’s] decision to keep coming back for more drugs).  Even disregarding the very real likelihood that these four [undercover] Visits presented a vivid snapshot of the [Petitioner’s] practice in general, the blithe manner in which he doled out controlled medicine to this undercover officer was nothing short of astonishing.

Id. at 16 (citation omitted).

On September 29, 2021, Petitioner and the Virginia Board of Medicine entered into a consent order that prohibited him from prescribing Schedule II – V controlled substances.  CMS Ex. 5, at 5.  On August 15, 2022, the Virginia Board of Medicine reinstated Petitioner to the unrestricted practice of medicine in Virginia.  CMS Ex. 4.5 

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B.        CMS revoked Petitioner’s Medicare enrollment and placed him on the preclusion list.

By letter dated June 13, 2022, CMS revoked Petitioner’s Medicare enrollment and billing privileges effective July 13, 2022.  CMS Ex. 3, at 1.  The letter specified that Petitioner’s Medicare privileges were being revoked under 42 C.F.R. § 424.535(a)(13) due to the revocation of Petitioner’s DEA Certificate.  Id.  CMS imposed a five-year reenrollment bar pursuant to 42 C.F.R. § 424.535(c).  Id. at 3.  CMS also added Petitioner to the preclusion list based on the revocation of his Medicare enrollment.  Id. at 1.

On August 16, 2022, Petitioner requested that CMS reconsider its revocation and preclusion list determinations, arguing, among other things, that he changed his prescription practices, he is applying to reinstate his DEA Certificate, and there is a shortage of primary care physicians in his community.  CMS Ex. 2, at 1-2.  Two days later, Petitioner applied for a new certificate of registration with the DEA.  CMS Ex. 6.  On September 21, 2022, Petitioner agreed to pay the United States government $50,000 to settle civil penalty claims arising from the unlawful prescribing practices discovered during the DEA’s undercover investigation.  CMS Ex. 7, at 2.  The DEA settlement did not release Petitioner from any criminal or administrative liability.  Id. at 3. 

On October 18, 2022, CMS issued an unfavorable reconsidered determination, upholding Petitioner’s revocation, five-year reenrollment bar, and placement on the preclusion list.  CMS Ex. 1, at 1, 6.  CMS noted that none of Petitioner’s various contentions, including his intent to obtain a new DEA Certificate, “negate the fact” that his DEA Certificate was revoked and remains revoked.  Id. at 3.  CMS recounted “the facts underlying the revocation” of Petitioner’s DEA Certificate and found that those facts “fully support the revocation of his Medicare enrollment” and five-year reenrollment bar.  Id. at 3-4 (summarizing the DEA’s findings and concluding that Petitioner’s “revocation is an appropriate utilization of [CMS’s] discretionary authority”).  

CMS further determined that each of the elements for including Petitioner on the preclusion list are satisfied.  Id. at 4-6.  CMS found the conduct that led to Petitioner’s revocation is detrimental to the best interests of the Medicare program, considering the seriousness of the conduct underlying the revocation, the degree to which that conduct could affect the integrity of the Medicare program, and other evidence that CMS deemed relevant.  Id. at 5-6 (analyzing the regulatory factors and noting that Petitioner “not only issued illegitimate controlled substance prescriptions . . . but he also ignored clear warning signs of opioid dependency or addiction”).  In upholding the preclusion list determination, CMS pointed out that Petitioner’s “inadequate medical visits” and “dangerous prescribing” are “precisely the type of conduct that the CMS Preclusion List was intended to deter within the Medicare program.”  Id. at 6.

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C.        The ALJ upheld Petitioner’s revocation and placement on the preclusion list.

Petitioner requested an ALJ hearing, challenging CMS’s reconsidered determination.  ALJ Decision at 2; Request for Hearing (RFH).  Petitioner did not dispute that his DEA Certificate was revoked, but argued that revocation of his Medicare enrollment was inappropriate because:  he applied for a new DEA Certificate; CMS revoked his billing privileges nearly a year after his DEA Certificate was revoked; and the revocation of his billing privileges “may exacerbate” access to care issues for Medicare beneficiaries in his community due to a shortage of health care providers.  RFH at 5.  Petitioner acknowledged that CMS had the authority to impose a reenrollment bar of up to ten years but argued that CMS abused its discretion by imposing a five-year bar.  Id. at 5-6.  Petitioner further challenged his placement on the preclusion list.  Id. at 2-4. 

The ALJ upheld CMS’s determination to revoke Petitioner’s Medicare enrollment (effective July 13, 2022) under 42 C.F.R. § 424.535(a)(13)(i) “based on the evidence and Petitioner’s admission (RFH at 4) that the DEA revoked” his DEA Certificate.  ALJ Decision at 10-11.  The ALJ rejected Petitioner’s various arguments for overturning his revocation and declined to review the length of the reenrollment bar.  Id. at 10-13.  The ALJ further concluded that CMS had a lawful basis to include Petitioner on the preclusion list because (i) Petitioner’s Medicare enrollment was revoked, (ii) he is under a reenrollment bar, and (iii) CMS determined that the conduct that led to the revocation is detrimental to the best interests of the Medicare program.  Id. at 12. 

Standard of Review

In appeals under 42 C.F.R. Part 498, the Board reviews disputed factual issues to determine whether the ALJ’s decision is supported by substantial evidence in the record as a whole, and reviews disputed issues of law to determine whether the ALJ decision is erroneous.  See Guidelines – Appellate Review of Decisions of Administrative Law Judges Affecting a Provider’s or Supplier’s Enrollment in the Medicare Program (Guidelines), “Completion of the Review Process,” ¶ (c), available at https://www.hhs.gov/about/agencies/dab/different-appeals-at-dab/appeals-to-board/guidelines/enrollment/index.html?language=en.

Analysis

Petitioner filed a request for review (RR) arguing that the ALJ erred:  (i) by sustaining the revocation of his Medicare enrollment based on the revocation of his DEA Certificate because he applied to “regain” his DEA Certificate and, once approved, the basis for his Medicare revocation will be “moot” (RR at 7-9); (ii) by not reviewing whether CMS properly exercised its discretion to revoke given the “health care needs of the people in his service area” (RR at 9-10); (iii) by not reviewing the length of Petitioner’s five-year

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reenrollment bar (RR at 11-14); and (iv) by sustaining CMS’s determination to include Petitioner on the preclusion list (RR at 14-15). 

CMS filed a response brief, arguing that the ALJ Decision should be affirmed because it is supported by substantial evidence and not legally erroneous.  Petitioner then filed a reply brief, reporting that the DEA denied his application for a new DEA Certificate.  Reply at 1.  Undeterred, Petitioner now asserts that “the DEA revocation was only a technicality, and so [Petitioner] should have been reconsidered as though he still had his DEA Certificate.”  Id. at 2-3.  We reject Petitioner’s arguments because they are legally erroneous and unsupported by the record.6 

I.         The ALJ’s conclusion that CMS had a lawful basis to revoke Petitioner’s Medicare enrollment under 42 C.F.R. § 424.535(a)(13)(i) is supported by substantial evidence and free of legal error.

On review of a determination to revoke a supplier’s Medicare enrollment and billing privileges, an ALJ and the Board “decide only whether CMS has established a lawful basis for the revocation” under 42 C.F.R. § 424.535(a).  Cornelius M. Donohue, DPM, DAB No. 2888, at 4 (2018).  Although the regulation affords CMS discretion to revoke in a particular case, the role of the ALJ and the Board “is limited to determining whether CMS’s action is legally authorized and does not extend to second-guessing whether CMS properly exercised its discretion . . . .”  Acute Care Homenursing Servs., Inc., DAB No. 2837, at 9 (2017).  Thus, if the regulatory elements for revocation are satisfied, “then the revocation must be sustained.”  Douglas Bradley, M.D., DAB No. 2663, at 13 (2015).

CMS may revoke a physician’s Medicare enrollment and billing privileges if the physician’s DEA “Certificate of Registration to dispense a controlled substance is currently suspended or revoked . . . .”  42 C.F.R. § 424.535(a)(13)(i).  Here, there is no dispute that, effective October 20, 2021, the DEA revoked Petitioner’s DEA Certificate to dispense controlled substances.  CMS Ex. 8.  Petitioner’s DEA Certificate remained revoked at the time of CMS’s revocation decision in June 2022.  CMS Ex. 3; RR at 3-4.  CMS had a lawful basis to revoke Petitioner’s Medicare enrollment in June 2022 because Petitioner’s DEA Certificate was currently revoked.  42 C.F.R. § 424.535(a)(13)(i).

Petitioner argues that “[t]he ALJ erroneously relied on CMS’s reasoning that Dr. Akbar’s lack of a current DEA Certificate is sufficient to result in the revocation of his Medicare billing privileges.”  RR at 9.  Petitioner is incorrect.  The revocation of Petitioner’s DEA Certificate plainly establishes a lawful basis for CMS to revoke his Medicare enrollment.

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See John O. Dimowo, M.D., DAB No. 3101, at 6-7 (2023).  Moreover, the timing of CMS’s decision to revoke (less than a year after the revocation of Petitioner’s DEA Certificate) provides no basis to set aside CMS’s revocation decision.  Dimowo at 7-8 (“CMS may revoke a physician’s Medicare enrollment at any time based on the DEA’s revocation if the regulatory elements in section 424.535(a)(13)(i) are met.”).

It also makes no difference that Petitioner applied for a new DEA Certificate following the revocation of his Medicare billing privileges.  See Dimowo at 10-11 (affirming ALJ’s conclusion that physician’s efforts to obtain a new DEA certificate do not affect CMS’s authority to revoke the physician’s Medicare enrollment).  There is no record evidence indicating that Petitioner’s DEA Certificate was reinstated or otherwise renewed after October 20, 2021.  In fact, Petitioner concedes that the DEA denied his application for a new DEA Certificate on October 4, 2024.  Reply at 1.  Even if Petitioner were to obtain a new DEA Certificate in the future, such a development would not negate the legal basis for CMS’s revocation decision.  See Dimowo at 11 (“No statute or regulation requires or permits an ALJ or the Board to overturn an enrollment revocation lawfully imposed under section 424.535(a)(13)(i) merely because the physician subsequently obtains a new Certificate of Registration.”).  Accordingly, Petitioner’s efforts to obtain a new DEA Certificate have no bearing on this matter.  Id. at 10-11.  

Petitioner also argues that although “42 C.F.R. § 424.535(a)(13)(ii) allows for revocation if a state licensing board revokes a physician’s prescribing authority,” his “prescribing rights were restored upon appeal by Virginia’s Board of Medicine.”  RR at 8; see also Reply at 2-3.  Petitioner’s argument is irrelevant and immaterial because his Medicare enrollment was not revoked under section 424.535(a)(13)(ii) due to any decision of Virginia’s Board of Medicine. 

Petitioner’s further contention that the revocation of his DEA Certificate is “only a technicality” that the Board should somehow disregard (Reply at 2-3) has no merit.  The DEA revoked Petitioner’s registration to dispense controlled substances having found that he “did not unequivocally accept responsibility for his misconduct,” and that his registration to dispense controlled substances “is inconsistent with the public interest.”  CMS Ex. 8, at 2-3.  Such a determination is not a mere “technicality” but has significant legal consequences, including the revocation of Petitioner’s Medicare enrollment.

We affirm the ALJ’s conclusion upholding the revocation of Petitioner’s Medicare enrollment under section 424.535(a)(13)(i) because it is supported by substantial evidence and free of legal error.

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II.        Neither the ALJ nor the Board is authorized to set aside CMS’s revocation decision based on access to care concerns.

Petitioner asserts that the ALJ erred by failing to consider the effect his Medicare revocation may have on “the health care needs of the people in his service area.”  RR at 9.  Petitioner argues that he is a primary care physician in a “Health Professional Shortage Area” and that revoking his Medicare privileges will increase access to care problems for medically underserved patients, “during a time when COVID-19 and influenza are still relevant.”  Id. at 10.  CMS considered and rejected this argument on reconsideration.  CMS. Ex. 1, at 4 (finding that Petitioner “provided no specific information to corroborate this contention”).  The ALJ appropriately declined to address this issue, noting that ALJs are not authorized to review CMS’s exercise of discretion to revoke when there is a legal basis for revocation.  ALJ Decision at 11.  

The Board has long held that “when reviewing a Medicare enrollment revocation, the Board and its ALJs are limited to deciding whether the regulatory prerequisites for revocation have been satisfied.”  Donohue at 10.  “[I]f CMS establishes that the regulatory elements necessary for revocation are satisfied, as they are here, then the revocation must be sustained, and neither the administrative law judge nor the Board may substitute its discretion for that of CMS in determining whether revocation is appropriate under all the circumstances.”  Bradley at 13 (internal quotation marks omitted).  “Because we conclude that the regulatory elements in section 424.535(a)(13)(i) are met in this case, we must sustain the revocation regardless of other factors,” such as the impact Petitioner’s revocation may have on patients in the community.  See Dimowo at 8 (rejecting similar argument raising access to care concerns due to the COVID-19 pandemic); see also Blair Allen Nelson, DAB No. 3024, at 11 (2020) (rejecting supplier’s contention that revocation should be set aside due to the alleged hardship it will impose by depriving the community of an experienced physician); Daniel Wiltz, M.D., et al., DAB No. 2864, at 12 (2018) (upholding CMS’s determination to revoke without regard to “the potential impact of revocation on the supplier’s patients” where there is a valid legal basis for the revocation). 

III.      The length of Petitioner’s reenrollment bar is not reviewable by the ALJ or the Board.

Petitioner argues that the ALJ erred by upholding CMS’s imposition of a five-year reenrollment bar.  RR at 11-14.7  The ALJ, however, made no determination about the length of the reenrollment bar.  ALJ Decision at 12.  Rather, the ALJ declined to “review the duration of [the] five-year reenrollment bar,” recognizing that CMS’s determination of the reenrollment bar is not one of the “initial determinations” that an ALJ or the Board

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is empowered to review under 42 C.F.R. Part 498.  Id. (citing Vijendra Dave, M.D., DAB No. 2672, at 9-10 (2016)).  Indeed, “[t]he Board has repeatedly held that the duration of a reenrollment bar is not an initial determination subject to review by the ALJ or the Board.”  Dimowo at 12-13 (collecting cases).  “Where, as here, CMS had a valid basis to revoke a supplier’s Medicare billing privileges, the ALJ and the Board must sustain the revocation and may not disturb the length of the re-enrollment bar set by CMS or the date that the re-enrollment bar began.”  Lilia Gorovits, M.D., P.C., DAB No. 2985, at 16 (2020).    

IV.       The ALJ did not err in concluding that CMS had a lawful basis to include Petitioner on the preclusion list.  

CMS may place an individual on the preclusion list when (i) the individual is currently revoked from Medicare for reasons other than that stated in 42 C.F.R. § 424.535(a)(3) (i.e., certain felony convictions), (ii) the individual is under a reenrollment bar, and (iii) CMS determines that the conduct that led to the revocation is detrimental to the best interests of the Medicare program.  42 C.F.R. §§ 422.2 (Part C), 423.100 (Part D).  As the ALJ found, all three requirements for including Petitioner on the preclusion list are satisfied.  ALJ Decision at 12.

Petitioner challenges his placement on the preclusion list, arguing that his Medicare enrollment should not have been revoked and the duration of the reenrollment bar is unreasonable.  RR at 15 (“Dr. Akbar’s objection is that if his revocation should not have been imposed because of the pending nature of his DEA application and the re-enrollment bar exceeded what was reasonable based on prior CMS decisions, then his name should not have been added to the Preclusion List.”).  We reject these arguments having determined that CMS had a legal basis to revoke Petitioner’s Medicare enrollment (for a reason other than that stated in section 424.535(a)(3)) and because there is no dispute Petitioner is under a five-year reenrollment bar (the duration of which is not reviewable by the Board).  See supra at pp. 7-10.

We also reject Petitioner’s assertion that CMS “failed” to determine that the conduct underlying Petitioner’s revocation is detrimental to the best interests of the Medicare program.  RR at 15.  The record plainly shows that CMS appropriately considered each of the relevant regulatory factors in determining that Petitioner’s conduct is detrimental to the best interests of the Medicare program, including (i) the seriousness of the conduct underlying the revocation, (ii) the degree to which that conduct could affect the integrity

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of the Medicare program, and (iii) other evidence that CMS deems relevant.  CMS Ex. 1, at 4-6 (analyzing regulatory factors under 42 C.F.R. §§ 422.2, 423.100).8 

Regarding the first factor (seriousness of the conduct), CMS explained that it considers revocation or suspension of a DEA certificate of registration for improperly prescribing controlled substances to be “very serious in nature” and a “clear indicator” that the physician misused or abused their prescribing authority.  CMS Ex. 1, at 5.  CMS found that Petitioner’s “inappropriate prescribing of controlled substances to be a very serious threat to the health, well-being, and safety of Medicare beneficiaries.”  Id.    

Regarding the second factor (integrity of the Medicare program), CMS made the following findings:

Dr. Akbar’s DEA [Certificate] was revoked because over the course of four visits from the same individual, he issued seven illegitimate controlled substance prescriptions (see Exhibit 8).  Also, Dr. Akbar did not obtain needed medical information and failed to address clear warning signs for a patient’s potential dependency on oxycodone.  CMS finds that Dr. Akbar’s actions demonstrate a propensity for negligent, dangerous and non-compliant behavior, as well as a complete disregard for state and federal government rules and regulations.  Furthermore, Dr. Akbar’s actions 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, Dr. Akbar’s participation in the Medicare program would negatively affect the integrity of the Medicare program.

Id. at 5 (citing CMS Ex. 8). 

Regarding the third factor (other evidence that CMS deems relevant), CMS noted that the preclusion list was established to comply with a Congressional mandate intended to prevent prescription drug abuse by Medicare beneficiaries under Medicare Parts C and D.  Id. at 5-6.  In creating the preclusion list, CMS noted that “the inclusion of problematic

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prescribers on the preclusion list 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.”  Id. at 6 (quoting 82 Fed. Reg. 56,336, 56,444 (Nov. 28, 2017)).  CMS, therefore, found it “relevant that Dr. Akbar not only issued illegitimate controlled substance prescriptions to the [undercover officer], but he also ignored clear warning signs of opioid dependency or addiction.”  Id. at 5.  In addition, CMS found that “[t]he inadequate medical visits and dangerous prescribing by Dr. Akbar that led to the revocation of his DEA [Certificate] is precisely the type of conduct that the CMS Preclusion List was intended to deter within the Medicare program.”  Id. at 6.

Petitioner identified no factual or legal flaw in any part of CMS’s decision to add him to the preclusion list, including CMS’s conclusion that the conduct that led to Petitioner’s revocation under section 424.535(a)(13)(i) is detrimental to the best interests of the Medicare program.  Accordingly, we find the requirements for placing Petitioner on the preclusion list were met and, therefore, affirm the ALJ’s conclusion that CMS had a lawful basis to place Petitioner on the preclusion list.

V.        Petitioner made no showing of “exceptional circumstances” that would compel CMS to remove him from the preclusion list.

Petitioner further argues that he should be removed from the preclusion list based on access to care concerns.  RR at 15.  Petitioner asserts that the “benefit” of him providing primary care services to his underserved community “outweighs CMS’ interest in keeping him on the Preclusion List.”  Id. (arguing that his services would be “advantageous to the Medicare program”).

Under the applicable regulations, CMS has discretion not to include a particular individual on (or if warranted, remove the individual from) the preclusion list if CMS determines that “exceptional circumstances” exist regarding beneficiary access to Part C Medicare Advantage (MA) items, services, or drugs, or Part D prescriptions.  42 C.F.R. §§ 422.222(a)(6), 423.120(c)(6)(vi).  In determining whether such “exceptional circumstances” exist, CMS considers:  (i) the degree to which beneficiary access would be impaired by the individual’s placement on the preclusion list, and (ii) any other evidence CMS deems relevant to its determination.  Id.  Importantly, “only CMS has the discretion not to place a provider on the preclusion list due to access to care concerns.”  84 Fed. Reg. 15,680, 15,794 (Apr. 16, 2019).  However, MA plans “can notify CMS if they believe there will be access to care issues by removing a particular provider from their network, and CMS will notify the plan of its determination regarding the preclusion.”  Id.  

Although Petitioner is a primary care physician who may provide services to non-Medicare beneficiaries in his community, Petitioner provided no evidence that beneficiary access to Part C (MA) items, services, and drugs, or Part D prescriptions have

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been impaired due to his placement on the preclusion list.  Moreover, Petitioner made no showing that any MA plan requested that CMS not include or remove Petitioner from the preclusion list based on access to care concerns.  Petitioner made no showing of “exceptional circumstances” that would compel CMS to remove him from the preclusion list.9   Absent evidence of “exceptional circumstances” regarding beneficiary access to Part C items, services, or drugs, or Part D prescriptions, CMS had no basis to remove Petitioner from the preclusion list.  See 42 C.F.R. §§ 422.222(a)(6), 423.120(c)(6)(vi). 

Conclusion

We affirm the ALJ’s conclusion that CMS lawfully revoked Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(13)(i) with an effective date of July 13, 2022.  We further affirm the ALJ’s conclusion that CMS lawfully placed Petitioner on the preclusion list.