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                              John O. Dimowo, M.D., DAB No. 3101 (2023)
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John O. Dimowo, M.D., DAB No. 3101 (2023)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Appellate Division





John O. Dimowo, M.D.
Docket No. A-22-33Decision No. 3101June 29, 2023

        
              
    

      FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

John O. Dimowo, M.D. (Petitioner) appeals the decision of an administrative law judge (ALJ) in *John O. Dimowo, MD*, DAB CR5994 (ALJ Decision).  The ALJ upheld the determination of the Centers for Medicare & Medicaid Services (CMS) to revoke Petitioner’s Medicare enrollment under 42 C.F.R. § 424.535(a)(13) because Petitioner’s Drug Enforcement Administration (DEA) Certificate of Registration was revoked.  The ALJ further upheld CMS’s determination to add Petitioner’s name to the preclusion list related to Medicare Parts C and D.  We affirm the ALJ Decision because it is supported by substantial evidence and free of legal error.

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 currently enrolled supplier’s Medicare enrollment and any corresponding supplier agreement for any of the reasons listed under 42 C.F.R. § 424.535(a).  Under section 424.535(a)(13), CMS may revoke a physician’s Medicare enrollment if the physician’s “Drug Enforcement Administration (DEA) Certificate of Registration is suspended or revoked.”  *Id*. § 424.535(a)(13)(i).1

**Page 2**

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.”  42 C.F.R.§ 424.535(c)(1).  “Revocation becomes effective 30 days after CMS or the CMS contractor mails notice of its determination to the provider or supplier, except if the revocation is based on Federal exclusion or debarment, felony conviction, license suspension or revocation, or the practice location is determined by CMS or its contractor not to be operational.”  *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 Medicare Part C (Medicare Advantage) and Medicare Part D (Voluntary Medicare Prescription Drug Benefit) as part of its effort to “prevent fraud, waste, and abuse, and to protect Medicare enrollees.”  *See*82 Fed. Reg. at 56336, 56448 (Nov. 28, 2017); 83 Fed. Reg. 16440, 16646 (Apr. 16, 2018).  An individual placed on the preclusion list is, after proper notice, 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 individual on the preclusion list when (i) the individual is revoked from Medicare (for reasons other than that stated in 42 C.F.R. § 424.535(a)(3)), (ii) the individual is currently under a reenrollment bar, and (iii) CMS has determined that the conduct underlying the revocation is detrimental to the best interests of the Medicare program.  42 C.F.R. §§ 422.2, 423.100.2  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*.

A 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).  A determination by CMS to revoke a supplier’s Medicare enrollment and place that individual 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.  *Id*. §§ 498.5(*1*)(1), 498.5(n)(1), 498.22.  If dissatisfied with the reconsidered determination, the supplier may request an ALJ hearing.  *Id*. §§ 498.5(*1*)(2), 498.5(n)(2), 498.40.  A party dissatisfied with an ALJ’s decision may seek review by the Board.  *Id*. §§ 498.5(*1*)(3), 498.5(n)(3), 498.80.

**Page 3**

Case Background

Petitioner is an anesthesiologist licensed to practice medicine in California and Texas.  ALJ Decision at 4, 5, 6; CMS Ex. 7, at 8; CMS Ex. 8, at 17; Request for Hearing (RFH) (Attachment G) at 48.  In 2012, based on multiple complaints that Petitioner was overprescribing controlled substances, including opioids and other dangerous drugs, the Medical Board of California and Los Angeles County Sheriff’s Department conducted an operation in which Petitioner was found to have prescribed controlled substances to undercover investigators without conducting a physical examination.  ALJ Decision at 4; CMS Ex. 8, at 22-23; CMS Ex. 7, at 4, 7.  Petitioner was arrested and charged with violating California Health and Safety Code § 11153(a).3  ALJ Decision at 4; CMS Ex. 8, at 23.

On May 14, 2015, in the Superior Court of California, County of Los Angeles, a jury found Petitioner guilty of seven felony counts of unlawful issuance of prescriptions for controlled substances under Health and Safety Code § 11153(a).  ALJ Decision at 4; CMS Ex. 7, at 2; CMS Ex. 8, at 23.  On March 28, 2016, the court reduced the felony convictions to misdemeanors, sentenced Petitioner to “time served,” and placed Petitioner on probation.  ALJ Decision at 4-5; CMS Ex. 7, at 7; CMS Ex. 8, at 23‐24.

On June 10, 2016, the Medical Board of California suspended, on an interim basis, Petitioner’s medical license.  ALJ Decision at 5; CMS Ex. 8, at 17-18.  On January 19, 2017, the Medical Board of California revoked, stayed, and placed on probation Petitioner’s medical license for seven years for his overprescribing practices, and restricted Petitioner’s medical license by not allowing him to prescribe certain controlled substances.  ALJ Decision at 5; CMS Ex. 8, at 1, 5; CMS Ex. 9, at 1.4

By letter dated June 30, 2017, the Office of Inspector General (I.G.) excluded Petitioner from participation in Medicare, Medicaid, and all federal health care programs for three years under section 1128(b)(3) of the Social Security Act (Act).  ALJ Decision at 7; CMS Ex. 5, at 2.  The exclusion notice stated in pertinent part:  “This exclusion is due to your misdemeanor conviction as defined in section 1128(i) . . . in the Superior Court of California . . . of a criminal offense related to the unlawful manufacture, distribution, prescription or dispensing of a controlled substance as defined under Federal or State

**Page 4**

law.”  CMS Ex. 5, at 2.  The exclusion became effective on July 20, 2017, twenty days from the date of the letter.  *Id*.5

By letter dated August 9, 2017, Novitas Solutions, Inc. (Novitas), a Medicare contractor, revoked Petitioner’s Medicare billing privileges effective July 20, 2017.  CMS Ex. 10, at 1.  The revocation was based on 42 C.F.R. § 424.535(a)(2) due to Petitioner’s exclusion from all federal health care programs.  *Id*.  Consistent with 42 C.F.R. § 424.535(c), Novitas imposed a three-year reenrollment bar beginning thirty days after the postmark date of the letter.  *Id*. at 2.6

On August 28, 2017, following a hearing, an administrative law judge for the DEA issued a recommended decision, recommending that Petitioner’s Certificate of Registration be revoked and that any pending application for renewal or modification be denied.  CMS Ex. 7, at 1, 15.7  The DEA may revoke a registrant’s Certificate of Registration if the registrant acted in a manner that renders continued registration “inconsistent with the public interest.”  *Id*. at 8 (quoting 21 U.S.C. § 824(a)(4)).  The DEA administrative law judge found that Petitioner had “[u]nlawfully prescribed controlled substances to three undercover agents on five separate occasions; was convicted in [California] state court of seven misdemeanors for issuing unlawful prescriptions for controlled substances; and [after that conviction] wrote three prescriptions in Texas without a valid DEA [Certificate of Registration] for a Texas location.”  *Id*. at 14.  The judge found that based on Petitioner’s hearing testimony, Petitioner had not fully accepted responsibility for his misconduct, and that Petitioner’s “limited acceptance of responsibility is outweighed by his prescribing transgressions.”  *Id*. at 14-15.  The judge found Petitioner’s transgressions particularly egregious because, among other things, “after being caught, convicted and sentenced for writing illegal prescriptions; after having had his medical license suspended by the [Medical Board of California] for writing illegal prescriptions; after taking courses

**Page 5**

on writing prescriptions . . . ; and then less than three months after he had his [California] medical license reinstated; he wrote illegal prescriptions in Texas.”  *Id*. at 15.  The judge found Petitioner’s misconduct, considering this timeline, “engenders absolutely no confidence that [Petitioner] can be entrusted with a DEA certificate of registration.”  *Id*.

On March 2, 2020, the DEA’s Acting Administrator adopted the recommended decision of the administrative law judge (with minor modifications) noting that Petitioner had not convinced the Administrator “that he could be entrusted with a DEA registration.”  CMS Ex. 7, at 1.  On March 19, 2020, the DEA published the decision and order revoking Petitioner’s Certificate of Registration effective April 20, 2020.  ALJ Decision at 2, 7; CMS Ex. 4, at 2; CMS Ex. 7, at 1.

By letter dated March 15, 2021, Noridian Healthcare Solutions (Noridian), a Medicare contractor, revoked Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(13) based on the DEA’s revocation of Petitioner’s Certificate of Registration.  CMS Ex. 2, at 1.  Noridian advised Petitioner that the revocation was effective April 14, 2021, thirty days after the date of the revocation letter.  *Id*.  Noridian imposed a five-year reenrollment bar and further noted that Petitioner would be added to the CMS preclusion list pursuant to 42 C.F.R. §§ 422.2, 422.222, 423.100, and 423.120(c)(6).  *Id*. at 1, 3.  Noridian advised Petitioner of the right to request reconsideration.  *Id*. at 2.

On or about April 4, 2021, Petitioner filed an application with the DEA seeking a new registration to prescribe controlled substances.  ALJ Decision at 7 (citing RFH Attachments F, G).

On April 9, 2021, Petitioner requested reconsideration of the decisions to revoke Petitioner’s Medicare enrollment and place Petitioner on the preclusion list.  CMS Ex. 3, at 1.  Petitioner acknowledged that the DEA revoked his Certificate of Registration but asked that CMS exercise its discretion not to revoke his Medicare enrollment.  *Id*. at 1, 2 (“It is my hope that CMS will use the discretional provision of 42 CFR § 424.535(a)(13) to my favor and allow me to retain my participation in Medicare, Medicaid and other Federal programs.”).

On May 27, 2021, CMS rendered an unfavorable reconsidered determination and upheld Petitioner’s revocation, the resulting five-year reenrollment bar, and Petitioner’s inclusion on the preclusion list.  CMS Ex. 1, at 1, 6.  The reconsidered determination included a finding by CMS that Petitioner’s conduct leading to the revocation was detrimental to the best interests of Medicare.  *Id*. at 6.

Petitioner timely requested an ALJ hearing to challenge the reconsidered determination.  ALJ Decision at 2.  Although Petitioner did not dispute that his Certificate of Registration had been revoked, Petitioner argued that revocation of his Medicare enrollment on that

**Page 6**

basis was inappropriate because the DEA hearing and appeals process took years to complete, Petitioner had already been excluded for three years while the DEA proceedings were pending, and Petitioner had recently applied for a new Certificate of Registration.  *Id*. at 8;Petitioner’s Brief (P. Br.) at 5-6.  Petitioner further acknowledged that CMS had the authority to impose a maximum reenrollment bar of ten years but argued that CMS abused its discretion by imposing a five-year reenrollment bar.  P. Br. at 6-7.  In addition, Petitioner challenged his placement on the preclusion list.  *Id*. at 4.

The ALJ found CMS had a legal basis for the revocation under section 424.535(a)(13) because there was “no dispute that the DEA revoked Petitioner’s Certificate of Registration in 2020.”  ALJ Decision at 8.  The ALJ further found that Petitioner’s various arguments for overturning the revocation were “unavailing,” and that the ALJ had no authority to review the length of the reenrollment bar.  *Id*. at 8-9.  Finally, the ALJ determined that CMS had a legitimate basis to add Petitioner to the preclusion list.  *Id*. at 10-13.

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

***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 or not 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).

**Page 7**

CMS may revoke a physician’s Medicare enrollment and billing privileges if the physician’s DEA “Certificate of Registration is suspended or revoked.”  42 C.F.R. § 424.535(a)(13)(i).  Here, there is no dispute that, effective April 20, 2020, Petitioner’s DEA Certificate of Registration was revoked.  ALJ Decision at 5-7, 8-9; CMS Ex. 4, at 2; CMS Ex. 7, at 1.  Petitioner concedes that the DEA’s action provided a basis to revoke Petitioner’s Medicare enrollment but complains that CMS’s revocation decision was untimely.  Request for Review (RR) at 2 (“While CMS may have legitimate basis to revoke my enrollment and billing privileges in the Medicare program because the DEA revoked my [Certificate of Registration], it was untimely done.”).  Petitioner further contends that CMS’s revocation decision should be overturned for various other reasons; however, none of Petitioner’s arguments challenge the legal basis for Petitioner’s revocation.  *Id*. at 1-5.  For the reasons explained below, we reject each of Petitioner’s arguments and find the ALJ’s conclusion that CMS had a lawful basis to revoke Petitioner’s Medicare enrollment based on the revocation of Petitioner’s DEA Certificate of Registration is supported by substantial evidence and free of legal error.

***Neither the ALJ nor the Board is authorized to set aside CMS’s revocation decision based on the timing of that decision.***Petitioner argues that the ALJ erred by failing to “consider the timing of the CMS decision to revoke [Petitioner’s] privileges on April 14, 2021.”  RR at 1-2.  Petitioner posits that CMS could have imposed the revocation “years ago at the time the convictions occurred as the decision is said to be based on the commitment of the misdemeanors, the suspended license, the license on probation[,] and the DEA revocation.”  *Id*. at 5.  Petitioner asserts that imposing a revocation “six years following a misdemeanor conviction” is not just or fair.  *Id.* at 3.

Petitioner misapprehends CMS’s revocation decision, which was based on section 424.535(a)(13)(i).  CMS may impose a revocation under section 424.535(a)(13)(i) when the DEA has acted to revoke or suspend the physician’s Certificate of Registration.  In this case, Petitioner’s DEA Certificate of Registration was revoked effective April 20, 2020.  CMS Ex. 7, at 1; CMS Ex. 1, at 4.  Consequently, CMS could not have revoked Petitioner’s Medicare enrollment under section 424.535(a)(13)(i) before April 20, 2020.

Petitioner further argues that “[w]aiting one year before taking an action after the DEA’s revocation . . . is not timely, is not justice[,] and is not fair.”  RR at 3.  The Board in *Donohue*rejected a similar contention that CMS waited too long to revoke a supplier’s billing privileges under section 424.535(a)(3) after learning of the supplier’s conviction at least five years earlier.  *See* *Donohue* at 3, 9.  The Board explained that “the Medicare statute and regulations do not require CMS to take action within a specified time frame after discovering information about a Medicare enrollee’s conviction,” and that “CMS may revoke at any time based on a conviction if the regulatory elements in section 424.535(a)(3) are satisfied.”  *Id*. at 9 (citing *Horace Bledsoe, M.D., et al*., DAB No. 2753,

**Page 8**

at 9 (2016)).  Still further, as the Board explained in *Bledsoe*, the Medicare statute and enrollment regulations do not limit “CMS’s authority to issue a revocation based on prior action *or inaction* by the Medicare program with respect to the supplier’s enrollment status.”  *Bledsoe* at 9 (emphasis added).

Petitioner presented no evidence as to when CMS learned of the DEA’s revocation decision, but even if Petitioner had done so, no Medicare statute or regulation required CMS to act on the DEA’s revocation decision sooner than it did.  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.  *Cf*.*Donohue* at 9; *Bledsoe*at 9.  Section 424.535(a)(13)(i) authorizes CMS to revoke the Medicare enrollment of a physician or other eligible professional if that professional’s DEA certificate of registration “is suspended or revoked.”  42 C.F.R. § 424.435(a)(13)(1).  As discussed above, those requirements were met here because Petitioner’s DEA Certificate of Registration was revoked effective April 20, 2020.

***Petitioner’s various arguments as to why CMS should have exercised its discretion not to revoke, and that revocation was unfair, provide no basis to reverse the revocation.***Petitioner asserts that CMS should have exercised its discretion “**not** to impose a sanction” (*i.e.*, revocation) when Petitioner “has already been punished by the [I.G.] with Medicare exclusion for 3 years” based on his prior misdemeanor conviction.  RR at 3 (emphasis in original).  Petitioner further contends that CMS abused its discretion and should have declined to revoke given the pandemic-era physician shortage in California.  *Id.* (“A new imposition of a discretionary sanction of Medicare enrollment revocation at this time attributed to DEA revocation of Certificate of Registration . . . is an afterthought by CMS, it is untimely, senseless in a pandemic with the shortage of physicians, unfair, and unjust.”).

As an initial matter, we do not review CMS’s revocation determination for “abuse of discretion.”  *See Blair Allen Nelson*, DAB No. 3024,at 10 n.10 (2020).  “[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).  Thus, “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.  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 had on the community during the COVID-19 pandemic.  *See Nelson* at 11 (rejecting supplier’s contention that revocation should be set aside due to the alleged hardship it will impose

**Page 9**

by depriving the community of an experienced physician); *see also* *Daniel Wiltz, M.D., et al.**,* DAB No. 2864, at 12 (2018) (“If, as here, CMS has a basis for revocation, the Board must uphold the determination to revoke without regard to, *e.g**.**,* . . . the potential impact of revocation on the supplier’s patients . . . .”).

Petitioner’s further contention that revocation is unwarranted because the exclusion imposed by the I.G. is sufficient punishment has no merit as a matter of law.  RR at 3.  I.G.-imposed exclusions and CMS revocations “are distinct remedial tools, each with its own set of prerequisites and consequences for the provider or supplier.”  *Dr. Robert Kanowitz*, DAB No. 2942, at 6 (2019) (internal quotation marks omitted).  The I.G.’s exclusion of Petitioner from all federal health care programs under section 1128(b)(3) of the Act based on Petitioner’s criminal conviction (CMS Ex. 5) does not negate CMS’s legal basis for revoking Petitioner’s Medicare enrollment under 42 C.F.R. § 424.535(a)(13)(i) due to the revocation of Petitioner’s DEA Certificate of Registration.  *See *Dinesh Patel, M.D.**, DAB No. 2551, at 9 (2013) (explaining that revocation and exclusion are two separate and distinct types of administrative enforcement actions carried out by two different HHS components acting under different legal authorities).  Nothing in 42 C.F.R. § 424.535 limits CMS’s authority to revoke a supplier or provider’s Medicare enrollment on the ground that the I.G. previously excluded the same supplier or provider.

Petitioner’s contention that revocation is redundant, given his prior exclusion, also overlooks the differing factual bases for those two measures.  The I.G. based Petitioner’s exclusion on Petitioner’s criminal conviction.  CMS Ex. 5.  CMS, however, based its revocation determination on the revocation of Petitioner’s DEA Certificate of Registration.  ALJ Decision at 9; CMS Ex. 7.  The DEA considered and weighed a multitude of circumstances and factors beyond Petitioner’s criminal conviction in reaching its decision, including the “egregiousness” of past misconduct, the illegal prescriptions Petitioner issued in Texas, and Petitioner’s limited acceptance of responsibility.  CMS Ex. 7, at 15.  The DEA relied on Petitioner’s additional misconduct – even after Petitioner was criminally prosecuted, subjected to professional discipline, and completed “remedial measures” – as demonstrating that Petitioner continued to pose an unacceptable risk to public health and safety and could not be “entrusted” with a Certificate of Registration.  *Id*.

Petitioner further asserts that revocation serves no purpose because Petitioner has “practiced medicine for twenty-five years in this country” and has “never abused the Medicare billing privileges.”  RR at 3.  These assertions are irrelevant because they fail to show that CMS lacked a lawful basis for revocation under section 424.535(a)(13)(i).  *Cf.* *Pepper Hill Nursing & Rehab. Ctr.*, DAB No. 2395, at 7 (2011) (rejecting contention that the supplier’s revocation did not serve a regulatory purpose because the issue on appeal was “simply whether CMS was authorized under the regulations to revoke [the supplier]’s [Medicare] billing privileges”).  Furthermore, Petitioner’s implication that

**Page 10**

revocation serves no purpose other than to protect Medicare from abusive or fraudulent billing practices is unfounded.  Besides safeguarding the program’s “fiscal integrity,” CMS’s revocation authority protects Medicare beneficiaries from unqualified healthcare practitioners and other persons or entities whose prior misconduct (such as improper prescribing of controlled substances) demonstrates a potential threat to beneficiaries’ health and well-being.  *See Bradley*at 17 n.17; *Fady Fayad*, DAB No. 2266, at 19 (2009) (“Revocation helps ensure access to high quality medical care by removing from the program practitioners and entities that pose a risk to its fiscal integrity and the well-being of program beneficiaries.”); *see also Sunsites Pearce Fire Dist.*, DAB No. 2926, at 8 (2019) (noting that the purpose of revocation is to promote health care program integrity “by removing providers whose prior conduct represents a threat to those programs and their beneficiaries”).

Petitioner further complains that revocation has caused economic harm because “almost all of [Petitioner’s] potential employers are Medicare contractors” and, as an anesthesiologist, “it is difficult to find work outside hospital and surgery center facilities.”  RR at 4.  The Board, however, has long held that “neither the ALJ nor the Board are authorized to set aside CMS’s revocation decision based on the financial impact it may have on Petitioner.”  *Nelson* at 12; *see also Donohue* at 10 (“[W]e must sustain a revocation that is lawful under the applicable regulations ‘regardless of other factors,’ such as the financial impact of the revocation on the supplier . . . .”) (citing *Fayad*at 16));*Bledsoe*at 11 (holding that the Board may not reverse a revocation “based on alleged harsh economic consequences to the entity whose enrollment and billing privileges are revoked”).  “[T]he Board has no authority to modify, rescind, or direct CMS to reconsider a revocation based on mitigating circumstances or claims that the revocation has caused financial or other hardship.”  *Vital Care Med. Transp., LLC*, DAB No. 2930, at 8 (2019) (citing *Patrick Brueggeman, D.P.M.*, DAB No. 2725, at 15 (2016)).

Petitioner further argues that the ALJ erred by failing to consider that Petitioner had an application pending for a new DEA Certificate of Registration “before Noridian (CMS) imposed its sanction.”  RR at 4-5.  The ALJ, however, did address this issue.  ALJ Decision at 9.  The ALJ found Petitioner had filed an application for a new DEA Certificate of Registration on or about April 4, 2021 (after the revocation notice, but before the effective date of revocation), and properly determined that “Petitioner’s efforts to obtain a new Certificate of Registration do not affect CMS’s authority to revoke Petitioner’s Medicare enrollment.”  *Id*. at 7, 9.  As the ALJ noted (*id.*at 9), during the rulemaking process resulting in the promulgation of 42 C.F.R. § 424.535(a)(13), a member of the public asked whether a physician could reenroll in the Medicare program when the DEA lifted its revocation of a Certificate of Registration, to which CMS responded that the physician could seek enrollment again “upon the expiration of his or her reenrollment bar.”  79 Fed. Reg. 29,844, 29,897 (May 23, 2014).  Accordingly, Petitioner’s efforts to obtain a new Certificate of Registration do not invalidate CMS’s

**Page 11**

revocation determination but merely affects Petitioner’s ability to reenroll once he becomes eligible to apply for reenrollment.  *See*ALJ Decision at 9.

Petitioner further asserts that the DEA issued a new Certificate of Registration “before the conclusion of the hearing,” and so “the reason for revocation has been cured.”  RR at 4-5.  This is a new argument that was not raised before the ALJ.  “A party appearing before the Board is not permitted to raise on appeal issues that could have been raised before the ALJ but were not.”  *Russell L. Reitz, M.D.*, DAB No. 2748, at 8 (2016); *see also Guidelines*, “Completion of the Review Process,” ¶ (a) (“The Board will not consider issues . . . which could have been presented to the ALJ but were not.”).  Because Petitioner did not raise this argument before the ALJ, and has not shown he could not have done so, the argument is not properly before us.  *See Reitz* at 8.

Even if the issue were properly before the Board, there is no evidence in the record that the DEA issued a new Certificate of Registration to Petitioner.  “The Board decides appeals of ALJ decisions on CMS enrollment determinations (which includes revocation of enrollment) based on the evidentiary record developed below during the ALJ proceedings.”  *Michael Turano, M.D.*, DAB No. 2922, at 16 (2019) (explaining that the Board is barred from admitting new evidence in provider/supplier enrollment appeals) (citing 42 C.F.R. § 498.86(a)).  Moreover, even if Petitioner had obtained a new Certificate of Registration after CMS’s revocation determination, and timely submitted evidence of that fact before the ALJ, it would not negate the legal basis for the revocation.  CMS had authority to revoke Petitioner’s Medicare enrollment in March 2021 because Petitioner’s DEA Certificate of Registration was revoked.  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.  The question is not whether Petitioner “cured” the basis for the revocation, but “whether there was a legal basis for the revocation when that determination was made.”  *Duke Ahn, M.D.*, DAB No. 3093, at 10 (2023).  Petitioner presented no evidence that CMS erred when it revoked Petitioner’s Medicare enrollment in March 2021 based on the DEA’s revocation of Petitioner’s Certificate of Registration.

Finally, to the extent that alleged unfairness is a common thread in many of these arguments by Petitioner, *see*, *e.g.*, RR at 3-4, “the Board has consistently held that it has no authority to provide equitable relief.”  *Mohammad Nawaz, M.D., and Mohammad Zaim, M.D., PA*, DAB No. 2687, at 16 (2016), *aff’d, Nawaz v. Price*, No. 4:16cv386, 2017 WL 2798230 (E.D. Tex. June 28, 2017), *aff’d, Nawaz v. Azar*, 920 F.3d 987 (5th Cir. 2019).  We repeatedly have applied that principle in cases involving revocation of suppliers’ Medicare billing privileges.  *See, e.g.*, *Turano* at 12 (“Neither the ALJ nor the Board may order reinstatement of billing privileges based on equity principles.”); *Neb Grp. of Arizona LLC*, DAB No. 2573, at 6 (2014) (“The Board has consistently held that

**Page 12**

it (and the ALJs) lack the authority to restore a supplier’s billing privileges on equitable grounds.”).  We apply and follow that principle in this appeal as well.

***The Board has no authority to reverse Petitioner’s revocation on constitutional grounds.***Petitioner argues that CMS’s determination to revoke his Medicare enrollment in 2021 when it “could have done [so] six years ago following [his] conviction,” and after he had “gone through six years of sanctions by various bodies,” amounts to a violation of the Eighth Amendment’s prohibitions on cruel and unusual punishment and excessive fines.  RR at 3-4.  The Board has repeatedly held that ALJs and the Board cannot overturn, on constitutional grounds, a revocation imposed in accordance with applicable statutes and regulations.  *See* *Nelson*at 9; *Michael Scott Edwards, OD, and M. Scott Edwards, OD, PA*, DAB No. 2975, at 17 (2019) (“The Board and the ALJ must follow the applicable enrollment law and regulations and have no authority to refuse to apply those authorities based on constitutional challenges.”), *appeal dismissed*, No. 2:29-cv-00048 (E.D.N.C. Feb. 26, 2020);*Donohue*at 8-9 (rejecting argument that revocation of billing privileges violates Eighth Amendment prohibition against “excessive fines”).  Moreover, revocation is not a “punishment”; rather, it is “a remedial measure whose purpose is not to punish the program participant for past misconduct but to protect the program and its beneficiaries from fraud, abuse, and other harm that might arise in the future.”  *Donohue*at 9 (quoting *Robert F. Tzeng, M.D.,*DAB No. 2169, at 14 (2008)).  The remedial purpose of revocation undermines Petitioner’s contention that it violates any Eighth Amendment prohibition.  *See id*. at 9 n.5.  As explained above, CMS had a permissible legal basis to revoke Petitioner’s Medicare enrollment under section 424.535(a)(13)(i).  Neither the ALJ nor the Board may overturn Petitioner’s revocation based on an Eighth Amendment challenge.

***The length of Petitioner’s reenrollment bar is not reviewable by the ALJ or the Board.***Petitioner argues that the ALJ erred in upholding CMS’s imposition of a five-year reenrollment bar.  *See*RR at 3 (“To now impose a 5-year bar on my privilege is abuse of power and discretion.”), 4 (“CMS revocation of my billing privileges and imposition of 5-year bar at this time, is excessive . . . .”).8  The ALJ did not err in declining to “review the length of the reenrollment bar imposed on Petitioner.”  ALJ Decision at 9.  The 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.  *See Lilia Gorovits, M.D., P.C.*, DAB

**Page 13**

No. 2985, at 15-16 (2020), *aff’d sub nom., Gorovits v. Becerra*, No. 20-1850, 2021 WL 1962903 (E.D. Pa. May 17, 2021); *Blossomwood Med., P.C., et al.*, DAB No. 2914, at 11 (2018), *aff’d*, No. 5:19-CV-00232, 2020 WL 5632970 (N.D. Ala. Sept. 21, 2020).  “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.”  *Gorovits*, DAB No. 2985, at 16.

***Petitioner’s revocation was effective on April 14, 2021.***Petitioner argues that the ALJ erred in upholding the April 14, 2021 effective date of revocation.  RR at 1-2.  According to Petitioner, the effective date of revocation should be May 14, 2015, the date of Petitioner’s criminal conviction.  *Id*. at 2 (“My billing privileges revocation and bar should be effective retrospectively on May 14, 2015.”).  Petitioner further argues, alternatively, that the effective date of revocation should have been based on the date of Petitioner’s California medical license suspension or license probation in 2016 and 2017.  *Id*.  We reject Petitioner’s contentions because Petitioner’s revocation under section 424.535(a)(13)(i) was not based on Petitioner’s criminal conviction or Petitioner’s medical license suspension or probation.

“The effective date of a supplier or provider’s revocation is controlled by operation of 42 C.F.R. § 424.535(g) and neither ALJs nor the Board may depart from, or ignore, that regulation’s plain text.”  *Five Star Healthcare, LLC*, DAB No. 3089, at 14 (2023) (internal quotation marks omitted).  Section 424.535(g) provides that a “[r]evocation becomes effective 30 days after CMS or the CMS contractor mails notice of its determination to the provider or supplier, *except if* the revocation is based on Federal exclusion or debarment, felony conviction, license suspension or revocation, or the practice location is determined by CMS or its contractor not to be operational.”  42 C.F.R. § 424.535(g) (emphasis added).  When a revocation is based on those limited exceptions, section 424.535(g) provides that “the revocation is effective with the date of exclusion or debarment, felony conviction, license suspension or revocation or the date that CMS or its contractor determined that the provider or supplier was no longer operational.”  *Id*.

Here, Noridian determined, in accordance with section 424.535(g), that Petitioner’s Medicare enrollment was revoked effective April 14, 2021 – thirty days after the March 15, 2021 notice of revocation.  CMS Ex. 2, at 1.  Petitioner has not identified any legal error in that determination or shown that any exception under section 424.535(g) applies.  Although Petitioner argues that the effective date of revocation should be the date of his conviction or the date his medical license was suspended, Petitioner’s revocation was not based on either of those things.  CMS Ex. 1, at 1, 4; CMS Ex. 2, at 1.  Petitioner also does not argue (and did not argue before the ALJ) that any of the exceptions under section 424.535(g) require a different effective date of revocation based

**Page 14**

on the date the DEA revoked Petitioner’s Certificate of Registration.  As previously stated, the Board will not consider issues not raised in the request for review, nor issues which could have been presented to the ALJ but were not.  *See* *Reitz* at 8; *Guidelines*, “Completion of the Review Process,” ¶ (a).

Petitioner’s reliance on two ALJ decisions, *Leonor Ordonez, M.D.*, DAB CR5556 (2020) and *Meindert Niemeyer, M.D.*, DAB CR4846 (2017), *aff’d in part*, DAB No. 2865 (2018), in support of his argument for an earlier effective date is misplaced.  *See*RR at 2.  ALJ decisions are not precedential and do not bind other ALJs or the Board.  *See* *Donohue* at 7.  In any event, the revocations in those cases were based on a felony conviction and medical license suspension, respectively, and were made effective on the dates of those events in accordance with section 424.535(g).  *See Ordonez*at 4 (felony conviction); *Niemeyer*, DAB CR4846, at 1, 5 (medical license suspension).  Neither case supports an earlier effective date here because Petitioner’s revocation was not based on either a felony conviction or a medical license suspension that would require a different effective date under section 424.535(g).

***The ALJ did not err in concluding that CMS had a legitimate basis to include Petitioner on the preclusion list.***Petitioner challenges his placement on the preclusion list, but only to the extent that he contends his Medicare enrollment should not have been revoked.  *See* RR at 5 (“I was in the process of being approved for a new DEA [Certificate of Correction], and therefore, CMS has no grounds for the revocation of my privileges and to put me on the preclusion list.”).  Petitioner raises no argument that CMS erred in interpreting or applying the regulatory requirements in 42 C.F.R. §§ 422.2 and 423.100 that govern placement on the preclusion list.  Therefore, having determined that CMS had a legal basis for revoking Petitioner’s Medicare enrollment under section 424.535(a)(13)(i), we further affirm the ALJ’s conclusion that CMS lawfully added Petitioner to the preclusion list under 42 C.F.R. §§ 422.2 (Medicare Part C) and 423.100 (Medicare Part D).

As the ALJ found, all three requirements for including Petitioner on the preclusion list are satisfied:  (i) Petitioner is revoked from Medicare (for a reason other than that stated in section 424.535(a)(3)); (ii) Petitioner is currently under a reenrollment bar; and (iii) CMS determined that the underlying conduct that led to Petitioner’s revocation is detrimental to the best interests of the Medicare program.  ALJ Decision at 10-12.  Petitioner points us to no factual or legal flaw in any part of that determination.  We find the ALJ’s conclusion that CMS lawfully added Petitioner to the preclusion list is supported by substantial evidence and free of legal error.

**Page 15**

Conclusion

We affirm the ALJ’s conclusion that CMS lawfully revoked Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(13)(i) with an effective date of April 14, 2021.  We further affirm the ALJ’s conclusion that CMS lawfully placed Petitioner on the preclusion list.

Endnotes

1  Section 424.535(a)(13)(i) was amended effective January 1, 2022; however, we cite to and apply the regulations in effect on March 15, 2021, the date of the revocation determination (CMS Ex. 2) at issue.  *See Meadowmere Emergency Physicians, PLLC*, DAB No. 2881, at 2 n.2 (2018).  Even if the amended provision were applicable here, the amendment would have no material effect on this decision.

2  An individual whose Medicare enrollment has been revoked under section 424.535(a)(3) or who was not enrolled in Medicare may be added to the preclusion list under other subsections of 42 C.F.R. §§ 422.2 and 423.100.

3   California Health and Safety Code § 11153(a) provides in pertinent part:  “A prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice.”

4  The Texas Medical Board also took action against Petitioner’s medical license.  In Petitioner’s DEA application dated April 4, 2021, Petitioner admitted that his “Texas license [was] placed on probation by Texas Medical Board because of the California misdemeanor conviction of March 28, 2016.”  RFH (Attachment G) at 48; ALJ Decision at 5.

5  On July 27, 2020, following Petitioner’s three-year exclusion period, the I.G. reinstated Petitioner’s eligibility to participate as a provider in Medicare and all federal health care programs.  CMS Ex. 6, at 2.  Revocation and exclusion are separate and distinct administrative actions carried out by two different HHS components pursuant to different regulatory authorities.  *See Dinesh Patel, M.D.*, DAB No. 2551, at 9 (2013).  A decision by the I.G. to reinstate Petitioner does not negate CMS’s decision to revoke Petitioner’s enrollment in Medicare.  *Cf. Dr. Robert Kanowit*z, DAB No. 2942, at 6-7 (2019) (holding that I.G.’s reinstatement determination has “no bearing” on supplier’s appeal of CMS’s decision to deny enrollment).

6  The record evidence does not indicate whether Petitioner appealed this revocation determination.  In any event, the legal basis for this revocation determination is not under review here.

7   Unless exempted under the law, “[e]very person who manufactures, distributes, dispenses, imports, or exports any controlled substance . . . shall obtain a [DEA] registration . . . .”  21 C.F.R. § 1301.11(a); *see also* 21 U.S.C. § 822(a).  “A separate registration is required for each . . . location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person.”  21 C.F.R. § 1301.12(a); *see also* 21 U.S.C. § 822(e).

8  The reenrollment bar imposed here is within the range authorized by 42 C.F.R. § 424.535(c)(1)(i).
  
          /s/
        Constance B. Tobias

                      Board Member
          /s/
        Kathleen E. Wherthey

                      Board Member
          /s/
        Michael Cunningham

                      Presiding Board Member Back to top
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