Brian O'Connor, DAB No. 3140 (2024)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Brian O’Connor (Petitioner) appeals the October 27, 2023 decision of an Administrative Law Judge (ALJ), Brian O’Connor, DAB CR6380 (2023) (ALJ Decision).  The ALJ affirmed the decision of the Centers for Medicare & Medicaid Services (CMS) to revoke Petitioner’s Medicare enrollment under 42 C.F.R. § 424.535(a)(9) for failure to report the suspension of his North Carolina physician assistant license, and under 42 C.F.R. § 424.535(a)(12) based on the termination of his participation in the North Carolina Medicaid program.  The ALJ left undisturbed CMS’s imposition of a five-year re‑enrollment bar and upheld CMS’s placement of Petitioner on CMS’s preclusion list.

For the reasons explained below, we affirm the ALJ Decision.

Legal Background

Under the Social Security Act (Act), the Secretary of Health and Human Services (Secretary) administers the Medicare program but has delegated most administrative responsibilities to CMS.  See Act § 1874; 46 Fed. Reg. 56,910, 56,911-03 (Nov. 19, 1981).  CMS, in turn, contracts with private entities known as Medicare Administrative Contractors (contractors) to perform certain program functions, including the enrollment of providers and suppliers in the Medicare program on CMS’s behalf.  See Act §§ 1816, 1842, 1866(j)(1)(A), 1874A; 42 C.F.R. §§ 405.818, 421.5(b), 421.404(c).  For purposes of the Medicare program, a physician assistant is a “supplier.”  See Act § 1861(d), (s)(2)(K)(i), (aa)(5)(A); see also 42 C.F.R. §§ 400.202 (defining “supplier”), 410.74 (providing conditions for Medicare payment for physician assistants’ services), 498.2 (defining “supplier” to include a “practitioner such as physician assistant”).

CMS regulations require physician assistants and other suppliers of health care services to enroll and maintain active enrollment status in the Medicare program to be paid for

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items and services covered by Medicare.  See 42 C.F.R. §§ 424.500, 424.505.¹  Enrollment confers “billing privileges,” i.e., the right to claim and receive Medicare payment for health care services provided to Medicare beneficiaries.  See id. §§ 424.502 (defining “Enroll/Enrollment”), 424.505.

CMS may revoke a supplier’s Medicare enrollment (and thus billing privileges) for any of the reasons stated in 42 C.F.R. § 424.535(a).  Relevant here, section 424.535(a)(9) authorizes CMS to revoke a supplier’s enrollment if the “supplier did not comply with the reporting requirements specified in § 424.516(d).”  As also relevant here, section 424.516(d)(1)(ii) requires that a supplier report “[a]ny adverse legal action” to their CMS contractor within 30 days.  Additionally, section 424.535(a)(12) provides in relevant part that CMS may revoke a supplier’s Medicare enrollment if the “supplier is terminated, revoked or otherwise barred from participation in a State Medicaid program.”  Id. § 424.535(a)(12)(i).  However, CMS may not revoke under section 424.535(a)(12) “unless and until a . . . supplier has exhausted all applicable appeal rights.”  Id. § 424.535(a)(12)(ii).

When CMS or its contractor revokes a supplier’s 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” that CMS imposes.  Id. § 424.535(c).  The effective date of a revocation based on section 424.535(a)(9) or (a)(12) is 30 days after CMS or its contractor mails the notice of revocation.  Id. § 424.535(g).  CMS sets the re‑enrollment bar for a period between one year and 10 years, depending on the severity of the basis for revocation.  Id. § 424.535(c)(1).

Additionally, when an individual is currently revoked and under a re-enrollment bar, and “CMS determines that the underlying conduct that led to the revocation is detrimental to the best interests of the Medicare program,” CMS may place that individual on its preclusion list.  42 C.F.R. §§ 422.2, 423.100.  An individual on the preclusion list is prohibited from receiving reimbursement for health care items, services, or drugs provided under Medicare Part C (Medicare Advantage) and from receiving reimbursement for drugs prescribed under Medicare Part D (Voluntary Prescription Drug Benefit).  See id. §§ 422.222(a); 422.224(a), (b); 423.120(c)(6).  CMS considers several factors in determining whether conduct is detrimental to the Medicare program, including the seriousness of the individual’s conduct, the degree to which the conduct could affect the integrity of the Medicare program, and any other evidence that CMS deems relevant.  Id. §§ 422.2, 423.100.

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A supplier may appeal their revocation and placement on the preclusion list in accordance with 42 C.F.R. Part 498.  See id. §§ 405.803; 422.222(a)(2), (3); 423.120(c)(6)(v)(A); 424.545(a).  A supplier must first request “reconsideration” of the CMS contractor’s initial determination.  Id. §§ 498.3(b)(17), (20); 498.5(l), (n); 498.22.  If dissatisfied with the reconsidered determination, the supplier may request a hearing before an ALJ, and if dissatisfied with the ALJ’s decision, may request review by the Departmental Appeals Board, Appellate Division (Board).  Id. §§ 498.40, 498.80, 498.82.

Factual and Procedural Background²

A.     Petitioner’s License Suspension and State Medicaid Program Termination

Petitioner was enrolled in the Medicare program as a physician assistant.  CMS Ex. 1, at 1-2.  Petitioner was first issued a license to practice as a physician assistant by the North Carolina Medical Board (North Carolina Board) on August 11, 2003.  CMS Ex. 3, at 1.  On August 28, 2020, the North Carolina Board issued Petitioner a public letter of concern after finding in an investigation that Petitioner was illegally prescribing Plaquenil to himself and his family members.  CMS Ex. 2, at 1; see also CMS Ex. 3, at 1-2.  The North Carolina Board determined that Petitioner was “stockpiling Plaquenil[] in the event [he] or one of [his] family members was diagnosed with COVID‑19.”  CMS Ex. 2, at 1; see also CMS Ex. 3, at 1‑2.

On March 16, 2021, Petitioner entered into a Consent Order, in which the North Carolina Board suspended Petitioner’s physician assistant license indefinitely, effective April 1, 2021.  CMS Ex. 3, at 4-5.  The North Carolina Board found that in addition to prescribing Plaquenil for himself and family members, Petitioner had prescribed multiple controlled substances to “Person A” with whom Petitioner had a significant personal relationship but no supplier/patient relationship.  Id. at 2.  The North Carolina Board further found that Petitioner “fraudulently utilized the credentials of several colleagues to obtain multiple controlled substances for himself and Person A.”  Id.  The North Carolina Board concluded that Petitioner had “violated rule 21 NCAC 32S .0212(8),” which prohibits prescribing controlled substances for the physician assistant’s use or to family members, persons living in the same residence, or anyone having a sexual relationship with the physician assistant.  Id. at 2-3.  Petitioner did not report his licensure suspension to CMS.  ALJ Decision at 6.

Afterward, in an April 17, 2021 notice, the State Medicaid agency informed Petitioner that he was terminated from the North Carolina Medicaid program (NC Medicaid), effective April 1, 2021, because of Petitioner’s “revoked credentials.”  CMS Ex. 5, at 2.

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The notice informed Petitioner of his appeal rights and the time for filing an appeal.  Id.  There is no evidence that Petitioner appealed his termination from NC Medicaid and as a result, his appeal rights were exhausted on June 16, 2021, or 60 days after the date of the notification letter.  See id. at 2-3.

B.     CMS’s Initial Determination and Reconsidered Determination

On July 30, 2021, Palmetto GBA, a CMS contractor, notified Petitioner that his Medicare enrollment was being revoked, effective August 29, 2021, on two grounds:  (1) pursuant to 42 C.F.R. § 424.535(a)(9) for failure to report the suspension of his North Carolina physician assistant license to CMS; and (2) pursuant to 42 C.F.R. § 424.535(a)(12), because he had been terminated from NC Medicaid, and his appeal rights concerning the termination had been exhausted.  See Request for Hearing (RFH) at 20-21.³  CMS also established a five‑year re-enrollment bar (until August 28, 2026) and added Petitioner’s name to the CMS preclusion list.  Id.; see also CMS Ex. 1, at 5.

Petitioner requested reconsideration from CMS.  ALJ Decision at 3; RFH at 13-18 (RFH letter).  Petitioner argued that the revocation should be reversed because the North Carolina Board reinstated Petitioner’s physician assistant license, he was no longer on the NC Medicaid exclusion list and was eligible to apply for reinstatement, he was licensed to practice as a physician assistant in four states despite his prescribing error, and because a five-year re‑enrollment bar is severe.  ALJ Decision at 3; RFH at 15-17, 25, 28-30.

On April 14, 2023, CMS issued an unfavorable reconsidered determination upholding the revocation of Petitioner’s Medicare enrollment under 42 C.F.R. § 424.535(a)(9) and (a)(12).  RFH at 61-70.  Additionally, based on Petitioner’s non‑compliance with Medicare requirements and the actions that led to the suspension of his license and termination from NC Medicaid, CMS upheld the five-year re-enrollment bar.  Id. at 66‑67.  Furthermore, CMS found that Petitioner’s conduct was “detrimental to the best interests of the Medicare program” and, therefore, upheld Petitioner’s placement on the preclusion list.  Id. at 67.

C.     ALJ Proceedings and Decision

On May 3, 2023, Petitioner timely requested an ALJ hearing to appeal CMS’s reconsidered determination.  ALJ Decision at 4; RFH.  Consistent with the ALJ’s Standing Prehearing Order, the parties exchanged pre-hearing briefs.  ALJ Decision at 4.

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The ALJ admitted all of CMS’s proposed exhibits into the record without objection.  Id.  The ALJ also admitted into the record Petitioner’s 13 exhibits submitted with the reconsideration request that were part of the record but had not been marked as exhibits before the ALJ.  Id.  Neither party submitted written direct testimony, so the ALJ determined that a hearing was unnecessary and decided the case on the written record.  Id.

Before the ALJ, Petitioner initially raised the same arguments raised in the request for reconsideration, namely that the underlying reasons for his revocation had been remedied and that he deserved to have it reversed.  See RFH at 2-6, 15-18; see also ALJ Decision at 7.  In Petitioner’s prehearing brief, however, Petitioner conceded that “he cannot challenge the initial reasons for revoking his termination from the Medicare program.  He was, in fact, terminated from [NC Medicaid] and he did not report the suspension of his physician assistant’s license to Medicare within 30 days.”  Petitioner’s Pre-Hearing Exchange (P. ALJ Br.) at 1; see ALJ Decision at 7.  Instead, Petitioner presented two new arguments:  (1) Palmetto GBA, as a CMS contractor, lacked the statutory authority to revoke Petitioner’s Medicare enrollment; and (2) Petitioner’s five-year re-enrollment bar was subject to ALJ review and should be reduced.  See ALJ Decision at 7; P. ALJ Br. at 1-2, 3-8.

The ALJ concluded that CMS was authorized to revoke Petitioner’s Medicare enrollment under 42 C.F.R. § 424.535(a)(9) and (a)(12), to impose a five-year re-enrollment bar, and to place Petitioner on the preclusion list.  ALJ Decision at 6-9.  Because Petitioner did not challenge the initial reasons for revoking his Medicare enrollment and “did not dispute the factual or legal bases to place Petitioner’s name on the CMS [p]reclusion [l]ist,” the ALJ upheld Petitioner’s revocation and placement on the preclusion list “without further discussion.”  Id. at 7.

The ALJ rejected Petitioner’s argument that CMS’s contractor lacked authority to revoke Petitioner’s Medicare enrollment.  Id. at 7-9.  The ALJ found that “CMS contractors can revoke a supplier’s enrollment, even when the regulation designates CMS as the revoking authority.”  Id. at 8.  The ALJ also found that CMS’s procedure of requiring contractors to obtain CMS’s consent before issuing a revocation was “sufficient to ensure CMS oversight” of contractor revocations.  Id. at 8 (citing CMS Ex. 6, at 3-4).  The ALJ further reasoned that any question as to the ­CMS contractor’s authority to revoke Petitioner’s enrollment is resolved by the fact that “a CMS hearing officer rendered the reconsidered determination,” the decision that constituted “CMS’s final determination and provides the basis for [ALJ] review.”  See id. at 8-9.

The ALJ also rejected Petitioner’s argument that the ALJ had jurisdiction to review and reduce the length of the re-enrollment bar imposed by CMS.  Id. at 9.  The ALJ determined that “prior administrative appellate decisions have interpreted the regulations as indicating the re-enrollment bar is not subject to [ALJ] review.”  Id. at 9.  Therefore,

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the ALJ concluded that he could not review “whether a five-year re-enrollment bar is appropriate in this case.”  Id. at 9.

Petitioner appealed to the Board.

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 legal issues 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.

Analysis

Before the Board, Petitioner does not challenge the ALJ’s holding that CMS appropriately revoked Petitioner’s Medicare enrollment under 42 C.F.R. § 424.535(a)(9) and (a)(12).  See Request for Review (RR) at 2‑3.⁴  Instead, Petitioner essentially repeats the two arguments raised earlier:  (1) that Palmetto GBA, the CMS contractor, did not have authority to revoke Petitioner’s Medicare enrollment, and (2) that the length of the re-enrollment bar is unwarranted and should have been reviewed by the ALJ.  See RR at 3-7; Petitioner’s Reply to CMS’ Response to Petitioner’s Request for Review (P. Reply Br.) at 1-4.  Petitioner also raises a constitutional due process claim relating to the re-enrollment bar.  RR at 11-12.

As explained below, we agree with the ALJ that CMS was authorized to revoke Petitioner’s Medicare enrollment under 42 C.F.R. § 424.535(a)(9) and (a)(12), to impose a five-year re-enrollment bar, and to place Petitioner on the preclusion list.  We also agree that Palmetto GBA, a CMS contractor, was authorized to issue the initial determination revoking Petitioner’s Medicare enrollment.  We further find that the ALJ correctly determined that he did not have authority to review the length of Petitioner’s re‑enrollment bar.  Finally, we explain that neither an ALJ nor this Board has the authority to consider Petitioner’s constitutional due process claim.  We therefore affirm the ALJ Decision.

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A.     Petitioner does not dispute that CMS had a legal basis to revoke his Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(9) and (a)(12).

The ALJ first determined that CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment, finding that “Petitioner did not timely report the indefinite suspension of Petitioner’s [physician assistant] license in North Carolina to a CMS contractor.  Therefore, CMS legitimately revoked Petitioner’s Medicare enrollment under 42 C.F.R. § 424.535(a)(9).”  ALJ Decision at 6.  The ALJ further concluded that “[NC Medicaid] terminated Petitioner’s participation in that program effective April 1, 2021.  There is no evidence that an appeal of the termination is pending.  Therefore, CMS legitimately revoked Petitioner’s Medicare enrollment under 42 C.F.R. § 424.535(a)(12).”  Id. at 6-7.

Petitioner does not challenge these conclusions and concedes that “he cannot challenge the initial reasons for revoking his Medicare billing privileges under the Medicare program.”  RR at 2-3.  We therefore summarily affirm this part of the ALJ Decision without further discussion.  See Amber Mullins, N.P., DAB No. 2729, at 5 (2016) (“Failure to articulate at least some disagreement with the bases for the ALJ decision permits the Board to summarily affirm the ALJ’s findings of fact and conclusions of law.” (citing Wisteria Care Ctr., DAB No. 1892 (2003))); see also Vijendra Dave, M.D., DAB No. 2672, at 6 (2016) (summarily affirming ALJ’s holding that CMS properly revoked the supplier’s Medicare enrollment where the supplier did not challenge the holding).

B.     The ALJ correctly concluded that Palmetto GBA, a CMS contractor, was authorized to revoke Petitioner’s Medicare enrollment.

Petitioner argues extensively that the revocation regulation at 42 C.F.R. § 424.535(a) forbade Palmetto GBA, the CMS contractor, from revoking Petitioner’s Medicare enrollment and that Petitioner’s revocation should thus be overturned “as a matter of law.”  See RR at 3-7; P. Reply Br. at 1-2.  Petitioner relies on the introductory language in the opening paragraph of section 424.535(a), which states “CMS may revoke” before listing the various grounds for revocation in paragraphs (a)(1)-(22) but does not reference contractors.  See, e.g., RR at 4 (“42 C.F.R. [§ 424.]535(a) states that “CMS may revoke a currently enrolled provider or supplier’s Medicare enrollment for the following reasons” (Petitioner’s emphasis)).  Petitioner further argues that most of the grounds for revocation refer to CMS “as the entity that is making the revocation determination or considering the factors involved with the revocation determination,” including section 424.535(a)(9) and (a)(12), the two bases for Petitioner’s revocation.  RR at 5.  Finally, as discussed more fully below, Petitioner argues that section 424.535(a)(11), which permits “CMS or its designated Medicare contractor” to revoke the Medicare billing privileges of a home health agency (HHA) “that cannot furnish supporting documentation verifying that the HHA meets the initial reserve operating funds requirement found in 42 CFR 489.28(a),”

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further supports his reading of the “CMS may revoke” language as forbidding contractors from issuing revocations for the other grounds in paragraph (a), including those that are the bases for the revocation here, (a)(9) and (a)(12).  Petitioner thus argues that “Medicare contractors are only able to issue revocations involving the initial reserve of operating funds for a HHA” and that “[i]t is clear from the plain language of the statute that CMS is the only entity with authority to issue a revocation decision based on the reasons at issue here.”  RR at 5.  None of these arguments warrants reversing the revocation, for the reasons explained below.

1. CMS’s contractor had the legal authority to issue the initial revocation determination.

The Board has rejected the argument that the “CMS may revoke” wording of the opening paragraph of section 424.535(a) forbids CMS contractors from issuing revocations, and the ALJ did not err in rejecting Petitioner’s argument here.  In Saeed A. Bajwa, M.D., DAB No. 2799, at 13-14 (2017), appeal dismissed per stipulation, Bajwa v. Price, No. 3:17-cv-00792 (N.D.N.Y. Dec. 28, 2017), where the physician supplier argued that “the plain language of the regulation reserved only to CMS the authority to make the revocation determination,” the Board noted that it “has concluded that although 42 C.F.R. § 424.535(a) states, ‘CMS may revoke,’ the contractor’s duly delegated administrative authority is such that a revocation notice issued by a contractor represents and conveys a decision by CMS.”  Bajwa at 13-14.  The Board also noted that CMS guidance, in its Medicare Program Integrity Manual (MPIM), directs contractors “to obtain prior approval of revocations and revocation letters from CMS’s Provider Enrollment & Oversight Group (PEOG),” and found that “while a contractor may determine that there is a basis for a revocation action and recommend an action to CMS, a notice of revocation ultimately issued by a contractor represents a revocation decision by CMS.”  Id. at 13 (footnote omitted) (citing MPIM, CMS Pub. 100‑08, Ch. 15, § 15.27.2.B).⁵

Similarly, the version of the MPIM applicable here provides specific detailed responsibilities for contractors to follow before issuing a revocation, including “[p]reparing a draft revocation letter;” “[e]-mailing the letter to PEOG . . . with additional pertinent information regarding the basis for revocation;” “[r]eceiving PEOG’s determinations and abiding by PEOG’s instructions regarding the case;” and only after “PEOG authorizes the revocation” can the contractor issue the revocation letter.  See CMS Ex. 6, at 4 (MPIM, Ch. 10, § 10.4.M.1.a (Rev. 10228, Effective July 27, 2020)).  Petitioner presented no evidence that the contractor failed to follow these processes or

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acted without CMS’s authorization.  Thus, as the Board held in Bajwa, while a contractor may determine that there is a legal basis for revocation, the notice of revocation issued by the contractor represents a revocation decision by CMS.  See Bajwa, DAB No. 2799, at 13; see also CMS Resp. Br. at 7-8 (“Contractors like Palmetto revoke suppliers with CMS’s authorization. . . .  Thus, even though Palmetto issued the notice, CMS revoked Petitioner by acting through Palmetto.”).

In holding that CMS contractors may issue revocations, the Board in Bajwa relied principally on Fady Fayad, M.D., DAB No. 2266 (2009), aff’d, Fayad v. Sebelius, 803 F. Supp. 2d 699 (E.D. Mich. 2011).  The Board there recognized that the relevant question is “whether Congress authorized CMS to subdelegate its revocation authority” to contractors, and held that sections 1842 and 1874A of the Act authorized CMS (as the Secretary’s delegatee) to subdelegate the authority to make revocation determinations to contractors because the Act authorizes CMS to retain contractors to perform certain necessary program functions and “revoking the billing privileges of a Medicare supplier is a program function that is ‘necessary to carry out the purposes’ of the Medicare program.”  Fayad at 17-19 (analyzing Act §§ 1842, 1874A(a)(4)).  The Board further noted that even if it were to conclude that revocations are not necessary to carry out the purposes of the Medicare program, the Board would still find the subdelegation of authority to contractors lawful “because [the Secretary] has, in effect, retained final authority over contractor-issued revocation determinations by subjecting them to review, when challenged, by departmental ALJs and the Board.”⁶  Id. at 19 (citing 42 C.F.R. § 424.545(a); Nat’l Park & Conservation Ass’n. v. Stanton, 54 F. Supp. 2d 7, 19 (D.D.C. 1999)).

The Board in Bajwa also cited Douglas Bradley, M.D., DAB No. 2663, at 14-15 (2015), appeal dismissed per stipulation, Bradley v. Burwell, No. 2:15-cv-08835 (D.N.J. June 2, 2017), which similarly relied on Fayad in rejecting essentially the same argument Petitioner makes here, “that section 424.535(a) authorizes ‘CMS’ to revoke Medicare billing privileges without expressly extending that discretionary authority to Medicare

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program contractors.”⁷  Bradley at 14-15 (citing Fayad, the Board explained that “even absent evidence of specific direction by CMS, the revocation would be lawful”); see also Brian K. Ellefsen, DO, DAB No. 2626, at 5-6 (2015) (applying the Fayad reasoning to reject the supplier’s contention that only CMS, and not its contractor, could deny a Medicare enrollment application under 42 C.F.R. § 424.530(a) which, in parallel with section 424.535(a), states that “CMS may” deny a provider’s or supplier’s Medicare enrollment for stated reasons); Wendell Foo, M.D., DAB No. 2904, at 24-25 (2018) (applying the Fayad reasoning to reject the supplier’s argument that “neither Congress nor the Secretary could constitutionally delegate discretionary authority” to private contractors to revoke Medicare enrollment), aff’d, Foo v. Azar, 420 F. Supp. 3d 1100, 1109 (D. Haw. 2019).

The Board has also applied Fayad to reject a supplier’s analogous argument that the “very language” of section 498.30 of the appeals regulations, “Limitation on reopening,” forbids Medicare contractors from reopening revocations because it states, “CMS or the OIG [Office of the Inspector General], as appropriate” issues the notice of reopening.  Lilia Gorovits, M.D., P.C., DAB No. 2985, at 8-9 (2020), aff’d, Lilia Gorovits, M.D., P.C. v. Becerra, No. CV 20-1850, 2021 WL 1962903 (E.D. Pa. May 17, 2021).  The Board summarized Fayad’s reasoning that the Act provides for administration of Medicare through contracts, including for actions “necessary to carry out the purposes” of the program, and that such actions include issuing revocations.  Id. (citing Fayad, DAB No. 2266, at 18-19).  The Board also noted, as did the ALJ here, that “under Part 498, CMS retains the authority to review on reconsideration a contractor’s revised initial determination to revoke a supplier’s billing privileges, as it did in this case.”  ALJ Decision at 9 (quoting Gorovits at 9).

2. Petitioner has not shown any intent by Congress or CMS to forbid CMS from using Medicare contractors to revoke Medicare enrollment.

Petitioner does not address the Board decisions discussed above (the ALJ cited Fayad and Gorovits).  Nor does Petitioner address the ALJ’s discussion of Fayad and its

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analysis of how the Act permits CMS to delegate Medicare program functions to contractors.  Petitioner further fails to address the MPIM provision cited in the ALJ Decision (and Bajwa) that allows contractors to issue revocation determinations with CMS oversight.  Instead, Petitioner relies solely on the argument that “[i]t is clear from the plain language of the statute”—by which Petitioner means 42 C.F.R. § 424.535(a)—“that CMS is the only entity with authority to issue a revocation decision based on the reasons at issue here.”  RR at 5.  Petitioner cites Sebelius v. Cloer, 569 U.S. 369 (2013), where the Court applied its prior holding that “[o]ur inquiry ceases [in a statutory construction case] if the statutory language is unambiguous and the statutory scheme is coherent and consistent”; Petitioner argues, “[i]f the language of a statute is plain and unambiguous, then it must be applied according to its terms.”  569 U.S. at 380 (second alteration in original; citation and internal quotation marks omitted); P. Reply Br. at 2.

Petitioner also makes what appears to be an argument (noted above) of first impression before the Board:  that paragraph (a)(11) stating that CMS “or its designated Medicare contractor” may revoke the billing privileges of an HHA related to initial reserve operating funds shows that “Congress clearly did not intend for revocation of a provider’s billing privileges to be one of those delegated functions [by CMS] except in a very limited situation.”  P. Reply Br. at 2.  Petitioner thus maintains that the district court decision affirming Fayad, which the ALJ cited, (and presumably the Board’s Fayad decision) “ignores” both “the plain meaning of” 42 C.F.R. § 424.535(a) and “established rules of statutory construction” in not adopting Petitioner’s restrictive reading of the regulation.⁸  P. Reply Br. at 1-2 (unnumbered, capitalization and emphasis omitted).  In this vein, Petitioner cites the Cloer statement that “where Congress includes particular language in one section of a statute, but omits it in another section of the same Act, it is generally presumed that Congress acts intentionally and purposely in the disparate inclusion or exclusion,” as support for Petitioner’s argument that “[t]he revocation statute clearly provides that Medicare contractors are only able to issue revocations involving the initial reserve of operating funds for a HHA.”  Id. at 2 (quoting Cloer, 569 U.S. at 378; citing 42 C.F.R. § 424.535(a)(11)).

1. Petitioner has not shown that Congress intended to forbid CMS from using Medicare contractors to revoke Medicare enrollment.

Petitioner’s position that section 424.535(a) shows intent to bar the contractor from issuing the initial revocation here has no merit, and the ALJ did not err in rejecting that argument and upholding the revocation.  As an initial matter, Petitioner in error repeatedly refers to the CMS regulation at 42 C.F.R. § 424.535(a) as a statute and its

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wording as indicia of congressional intent.  See, e.g., P. Reply Br. at 1 (“§ 42 CFR 424.535, the federal statute that gives CMS the authority to revoke a provider’s Medicare billing privileges”); RR at 5-6 (arguing, after citing section 424.535(a), that “[t]he revocation statute makes clear that when Congress wanted to give a Medicare contractor authority to issue a revocation or perform other acts under the revocation statute, it did so.”).  As CMS issued the regulation, however, its utility for determining Congress’s intent is necessarily limited.  See 71 Fed. Reg 20,754, 20,776 (Apr. 21, 2006) (CMS notice of final rule at subpart P of 42 C.F.R. Part 424); Neb. Health & Hum. Servs. Sys., DAB No. 1882, at 15 (2003) (explaining that the preamble to a draft notice of proposed rulemaking “is hardly an authoritative statement of congressional intent” because, among other reasons, it “was drafted by a federal agency”), rev’d on other grounds, Neb., Dep’t of Health & Hum. Servs. v. U.S. Dep’t of Health & Hum. Servs., 340 F. Supp. 2d 1, 13 (D.D.C. 2004) (“[T]he DAB correctly gave little weight to Nebraska’s attempt to rely on the draft notice because it is not an authoritative statement of what Congress intended.” (emphasis in original)), rev’d & remanded, 435 F.3d 326 (D.C. Cir. 2006).

As to Congress’s intent, Petitioner cites no statutory language, and no legislative history, suggesting that Congress, in authorizing CMS to delegate Medicare program functions to its contractors, intended to provide an exception for revocations or denials of Medicare enrollment or otherwise forbid those contractors from taking such actions, or to create a category of Medicare program functions that CMS could not administer through contractors.  See, e.g., Ark. Dep’t of Hum. Servs., DAB No. 1073, at 8 (1989) (explaining that legislative history “provides an important indication of congressional intent”).

2. Petitioner has not shown any intent by CMS to bar contractors from issuing initial enrollment revocation determinations.

As to CMS’s intent in issuing section 424.535(a), the more relevant inquiry, Petitioner similarly cites nothing, apart from Petitioner’s own interpretation of section 424.535(a), that might show that CMS ever intended the regulation to bar CMS contractors from issuing initial enrollment revocations, among their other responsibilities in administering Medicare program functions.  That CMS might have had such an intent in issuing the regulation is not persuasive or credible, for several reasons.

For one, CMS has made clear, through the MPIM language discussed above, its intent that contractors may take initial revocation actions, consistent with congressional understanding that contractors perform Medicare program functions as recognized by the Board and the district court in Fayad.  See CMS Resp. Br. at 7-8 (citing the MPIM and explaining that “[c]ontractors like Palmetto revoke suppliers with CMS’s authorization”).  In Med-Care Diabetic & Medical Supplies, Inc., DAB No. 2764, at 10-12 (2017), appeal dismissed per stipulation, Med-Care Diabetic and Medical Supplies, Inc. v. Price, No. 9:17-cv-80578 (S.D. Fla. Nov. 7, 2017), the Board recognized the MPIM as reflecting CMS’s intent in rejecting the argument of a supplier of mail-order diabetic supplies that

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CMS intended section 424.535(a)(8), “Abuse of billing privileges,” to apply only to claims for in-person services such as physician visits and not to claims for mail-order medical equipment.  The Board noted that the MPIM requires equipment suppliers to contact beneficiaries to verify necessity before sending supplies and held that “[i]t would be unreasonable to conclude that CMS intended to create an exception under subsection (a)(8) of the regulation for mail-order suppliers, and then issue interpretive guidance on compliance with the regulation that does not specifically exempt mail-order suppliers from the regulation’s reach.”  Med‑Care at 12.  It would be similarly unreasonable here to conclude that CMS intended the regulation to bar contractors from taking revocation actions where it issued guidance permitting them to do so.

CMS’s intent is also clear from its longstanding practice.  In this regard, we note that CMS has for many years used contractors to issue initial revocations of supplier and provider enrollments, as well as other administrative functions under Part 424 subject to ALJ and Board review, including denials of enrollment and setting enrollment effective dates.  See, e.g., 1866ICPayday.com, L.L.C., DAB No. 2289 (2009) (revocation of supplier billing number under 42 C.F.R. § 424.57(d), which states “CMS will revoke” a supplier’s billing privileges for noncompliance with requirements for durable medical equipment suppliers); US Ultrasound, DAB No. 2302 (2010) (denial of supplier enrollment); CompRehab Wellness Grp., Inc., DAB No. 2406 (2011) (revocation of provider enrollment), aff’d, CompRehab Wellness Grp., Inc. v. Sebelius, No. 11‑23377‑CIV, 2013 WL 1827675 (S.D. Fla. Apr. 30, 2013); see also all other Board enrollment decisions cited herein.

Additionally, Petitioner has cited no regulatory history of the enrollment regulations, such as CMS’s statements in the Federal Register preambles to the regulations when proposed and published and later revised, to show any intent to bar contractors from taking initial revocation actions.  See, e.g., A to Z DME, LLC, DAB No. 2303, at 6-7 (2010) (explaining that “preamble language demonstrates the intent of the regulations” governing provider or supplier enrollment); Med-Care, DAB No. 2764, at 12 (noting that the revocation of a supplier of medical supplies under section 424.535(a)(8) “is consistent with CMS’s prior statements in the preamble to the final rule about the intent of the regulation”).  Instead, CMS’s preamble statements in the proposed and final rules establishing subpart P of Part 424 do not show that CMS intended the introductory language of section 424.535(a) as permitting only CMS, and not its contractors, to issue revocations and, more generally, do not show any recognition of that topic as an issue to be addressed.  See 68 Fed. Reg. 22,064, 22,071-72, 22,084 (Apr. 25, 2003); 71 Fed. Reg 20,754, 20,761, 20,779 (Apr. 21, 2006).  Moreover, statements in subsequent, related rulemakings are not consistent with CMS having intended to prevent contractors from issuing revocations:

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• When CMS in February 2011 revised section 424.535(a) to permit revocation when “Medicaid billing privileges are terminated or revoked by a State Medicaid Agency,” it did not revise the overarching “CMS may revoke” language that begins paragraph (a).  76 Fed. Reg. 5,862, 5,964-65 (Feb. 2, 2011).  Yet, CMS in the preamble to the final rule described the revision as “allowing CMS, directly or through its contractor, to revoke Medicare billing privileges when a State Medicaid agency terminates, revokes, or suspends a provider or supplier’s Medicaid enrollment or billing privileges.”  76 Fed. Reg. at 5,946 (emphasis added); see 42 C.F.R. § 424.535(a)(12) (2011).⁹
• In proposing the February 2011 revision, CMS similarly stated, “we propose allowing CMS or its designated Medicare contractor to revoke Medicare billing privileges when a State Medicaid agency terminates, revokes, or suspends a provider or supplier’s Medicaid enrollment or billing privileges,” notwithstanding that then, as now, paragraph (a) of section 424.535 began with the “CMS may revoke” language that Petitioner relies on.  75 Fed. Reg. 58,204, 58,229 (Sept. 23, 2010) (emphasis added); see 42 C.F.R. § 424.535(a) (2009).
• Preambles to revisions of section 424.535(a) in 2008 show CMS reserving the authority to make the revocation determination for one ground for revocation— section 424.535(a)(8), authorizing revocation when the “provider or supplier submits a claim or claims for services that could not have been furnished to a specific individual on the date of service”—and even then, CMS indicated that the contractor would take the revocation action.  73 Fed. Reg. 36,448, 36,457, 36,461 (June 27, 2008).  In response to a comment that “there was not enough guidance given to the contractors to filter these claims which could cause overburdened contractors to implement this policy too widely,” CMS stated, “CMS, not a Medicare contractor, will make the determination for revocation under the authority at § 424.535(a)(8).  We will direct contractors to use this basis of revocation after identifying providers or suppliers that have these billing issues.”  Id. at 36,455 (emphasis added).  CMS also stated, “this final rule allows Medicare FFS contractors to revoke Medicare billing privileges when a provider or supplier submits a claim or claims for services that could not have been furnished to a beneficiary,” and “allows Medicare FFS contractors to revoke Medicare billing privileges when instructed to do so by CMS when a provider or supplier submits a claim or claims for services that could not have been furnished to a beneficiary.”  Id. at 36,448, 36,457 (emphasis added).

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• Notably, the final rulemaking that added subsection (a)(8), among other amendments to Parts 405, 424, and 498 of Title 42 of the Code of Federal Regulations, is titled “Medicare Program; Appeals of CMS or CMS Contractor Determinations When a Provider or Supplier Fails to Meet the Requirements for Medicare Billing Privileges.”  Id. at 36,448 (emphasis added).
• Regarding section 424.535(a)(11), which contains the text Petitioner cites stating that “CMS or its designated Medicare contractor may revoke,” the preambles to the proposed and final rules adding section 424.535(a)(11) effective January 1, 2011, contains no analysis of this wording indicating it reflected a CMS policy to limit contractor revocation actions to that revocation ground only.  As with the preambles to subpart P as initially published, there is no indication that CMS considered segregating certain functions from contractors.  The preamble therefore attributes no significance to the phrase “or its designated Medicare contractor” as used in section 424.535(a)(11).  Instead, the preamble discussion focuses on the issue of HHA financing and the ability of HHAs to secure sufficient reserve operating funds to alleviate concerns regarding the ability to provide adequate services to Medicare beneficiaries.  See, e.g., 75 Fed. Reg. 43,236, 43,264-67 (July 23, 2010).

Petitioner’s reading of section 424.535(a) as barring contractors from issuing initial revocation determinations also creates an apparent conflict with 42 C.F.R. § 405.800(b), which provides the notice requirements “[i]f CMS or a CMS contractor revokes a provider’s or supplier’s Medicare billing privileges,” and also provides the applicable effective dates “after CMS or the CMS contractor mails notice of its determination to the provider or supplier.”  42 C.F.R. § 405.800(b)(1), (2) (emphasis added).  The effective date provision identifies grounds for revocation also listed in section 424.535(a), making clear that both provisions concern the same actions.  Compare § 405.800(b)(2) (providing effective date of revocations “based on a 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”), with § 424.535(a)(2), (3), (5)(i).  Petitioner’s exclusionary interpretation thus violates another “well settled principle of statutory construction . . . that, if possible, the provisions should be given the most harmonious reading possible, so they do not conflict.”  V.I. Dep’t of Just., DAB No. 1061, at 9 (1989); see also Wash. State Dep’t of Soc. & Health Servs., DAB No. 1029, at 5-6 (1989) (“A general rule of statutory construction is that the provisions introduced by an amendment should be read together with the provisions of the original act that were reenacted or left unchanged, as if they had been originally enacted as one act, with effect given to each part and to be interpreted so that they do not conflict.”).

Petitioner has thus shown no intent by Congress or CMS to bar the contractor from issuing the initial revocation determination here.  For all of the reasons discussed, we conclude that Petitioner’s interpretation of section 424.535(a) as precluding Medicare

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contractors from issuing initial revocation determinations (except in the case of certain HHAs) is unreasonable.

3. CMS’s reconsidered determination, not the contractor’s initial determination, provided the basis for ALJ review.

We also agree with the ALJ that “it is significant that a CMS hearing officer rendered the reconsidered determination” in this case.  ALJ Decision at 8; see RFH at 61-70.  As Part 498 provides, CMS, through its hearing officer, issued the reconsidered determination affirming the revocation of Petitioner’s Medicare enrollment.  See RFH at 20‑21, 61-70; 42 C.F.R. §§ 498.3(b)(17); 498.5(l)(1); 498.22–.24; see also Gorovits, DAB No. 2985, at 9 (“Moreover, under Part 498, CMS retains the authority to review on reconsideration a contractor’s revised initial determination to revoke a supplier’s [enrollment], as it did in this case.”).  As the ALJ correctly stated, the reconsidered determination supersedes the initial determination, and “[i]t is the reconsidered determination that establishes CMS’s final determination and provides the basis for [ALJ] review.”  ALJ Decision at 8 (citing 42 C.F.R. §§ 498.5(l), (n), 498.20(b)(1), 498.24–.25, 498.40(a)); see also Willie Goffney, Jr., M.D., DAB No. 2763, at 4-5 (2017) (explaining that it is the reconsidered determination, not the contractor’s initial determination, that forms the basis for ALJ or Board review), aff’d, Goffney v. Azar, No. CV 17-8032 MRW, 2019 WL 13067036 (C.D. Cal. Sept. 25, 2019), aff’d sub nom. Goffney v. Becerra, 995 F.3d 737 (9th Cir. 2021); Vijendra Dave, M.D., DAB No. 2672, at 8 n.10 (2016) (holding, in an appeal challenging a Medicare enrollment revocation, that the ALJ and the Board are “limited to reviewing the basis for revocation articulated in the unfavorable reconsidered determination”); Precision Prosthetic, Inc., DAB No. 2597, at 11 (2014) (explaining that 42 C.F.R. § 498.5(l) “limits ALJs to considering the basis or bases for denial or revocation of enrollment and billing privileges set forth in the . . . reconsidered determination”).

Finally, as before the ALJ, CMS clarified and provided evidence, in the form of the MPIM provisions discussed above, that contractors like Palmetto GBA require CMS’s authorization before revoking a supplier’s Medicare enrollment, as the ALJ found.  See ALJ Decision at 8; CMS Resp. Br. at 6-7 (citing CMS Ex. 6 (MPIM, Ch. 10, § 10.4.M.1.a)); see also Bajwa, DAB No. 2799, at 13.  Petitioner does not dispute the MPIM’s instructions to contractors, that contractors can only revoke a supplier’s enrollment if CMS authorizes the revocation, nor did Petitioner present any evidence that the contractor here acted without CMS authorization.  We further agree with the ALJ that “[s]uch a procedure would be sufficient to ensure CMS oversight of revocations issued by cont[r]actors.”  ALJ Decision at 8; see also Gorovits, DAB No. 2985, at 8-9; Bajwa, DAB No. 2799, at 13; Bradley, DAB No. 2663, at 14.

Petitioner disputes the ALJ’s conclusion on the grounds that “the statutory authority cited by the ALJ does not state that premise” and that the regulation outlining the scope of the review process (section 498.3(a)(1), RR at 6 n.18) “applies to initial determinations

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issued by CMS regarding provider enrollment,” which here “was issued by a CMS contractor, not CMS.”  RR at 6-7 (emphasis omitted).  To the extent Petitioner argues that the initial revocation here is not an “initial determination” under 42 C.F.R. § 498.3(b)(17) because it was issued by Palmetto GBA, that argument fails for the same reasons we discuss above in rejecting Petitioner’s argument concerning the similar wording of 42 C.F.R. § 424.535(a).  Petitioner’s cramped focus on the presence or absence of specific words in the regulation does not address or show error in the reasoning of Fayad and its progeny, the district court’s decision affirming Fayad, or the ALJ Decision.  Petitioner’s reading of the regulations would also eliminate or render meaningless the reconsideration process CMS created in Part 498 (and utilized here by Petitioner), which, like Petitioner’s argument about the wording of section 424.535(a), would be contrary to other principles of statutory interpretation, to the extent they apply to CMS’s regulations at issue here.  Consistent with Part 498, Petitioner requested reconsideration of the contractor’s initial determination in accordance with 42 C.F.R. §§ 498.5(l)(1) and 498.22(a); CMS issued the reconsidered determination in accordance with 42 C.F.R. § 498.24; Petitioner then requested an ALJ hearing on the reconsidered determination in accordance with 42 C.F.R. § 498.5(l)(2); and Petitioner has now obtained Board review of the ALJ Decision under 42 C.F.R. § 498.5(l)(3).  Thus, the ALJ reviewed a final action from CMS (i.e., the reconsidered determination) and, through the ALJ and now Board review, the Secretary “retained final authority” over the contractor-issued revocation determination.  See Fayad, DAB No. 2266, at 19.

For all of these reasons, we find no error in the ALJ’s conclusion that Palmetto GBA was authorized to issue the initial determination revoking Petitioner’s Medicare enrollment.

C.     The ALJ correctly determined that he did not have the authority to review the length of the re-enrollment bar.

Petitioner argues that the ALJ erred in finding no authority to review the re-enrollment bar because “an ALJ is required to evaluate the appropriateness of the length of a re‑enrollment bar.”  RR at 3-4.  Petitioner contends that the Administrative Procedure Act (APA) provides for “judicial review” of the length of the re-enrollment bar, and the ALJ violated the APA by concluding the re‑enrollment bar was not reviewable.  See id. at 7-8 (citing Citizens to Pres. Overton Park, Inc. v. Volpe, 401 U.S. 402, 410 (1971); 5 U.S.C. § 701(a)(1)-(2)).  Additionally, Petitioner asserts that “there is no language granting CMS complete discretion and in fact, the statute gives a standard to be applied to determine the length of the re‑enrollment bar,” which requires a “fact-specific analysis of the severity” of the basis for the revocation.  Id. at 7-8 (citations omitted).  Petitioner further argues that the Fifth Circuit case in Shah v. Azar, 920 F.3d 987 (5th Cir. 2019), which the ALJ relied on, supports the Petitioner’s assertion that the ALJ can review the severity of the

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facts involved and overturn the re-enrollment bar “if it is ‘unwarranted by law or without justification in fact.’”  P. Reply Br. at 3 (quoting Shah, 920 F.3d at 998).¹⁰

As an initial matter, Petitioner’s reference to the APA’s “judicial review” provisions and related case law is misplaced in these administrative proceedings.  See Blair Allen Nelson, M.D., DAB No. 3024, at 11 (2020); Gorovits, DAB No. 2985, at 17.  “Judicial review” is the ability to seek federal court review of final agency actions, and Petitioner may seek judicial review of our decision here.  See 42 C.F.R. §§ 498.5(f)(2), (n)(3), 498.90(b).  The ALJ’s review authority in this case is “governed by the regulatory process established under 42 C.F.R. Part 498”—not the APA.  Nelson at 11 (citing Gorovits, DAB No. 2985, at 17).

Contrary to Petitioner’s assertion, the ALJ correctly determined that he did not have the authority to review the length of Petitioner’s re-enrollment bar.  42 C.F.R. § 498.3(b) lists certain “initial determinations” by CMS that are subject to administrative review, including a determination “to . . . revoke a . . . supplier’s Medicare enrollment in accordance with . . . [42 C.F.R.] § 424.535.”  42 C.F.R. § 498.3(b)(17)(i).  That list “does not include CMS’s decision on the duration of a post‑revocation re-enrollment bar.”  Gorovits, DAB No. 2985, at 15 (citing Dave, DAB No. 2672, at 10).  Thus, the Board has long held that when CMS lawfully revokes a supplier’s Medicare enrollment—as it did in this case—the ALJ and the Board “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; see also Nelson, DAB No. 3024, at 13 (affirming ALJ’s refusal to review the supplier’s challenge to the re‑enrollment bar duration because “the duration of a re-enrollment bar is not an initial determination subject to review by the ALJ or the Board”); Dave, DAB No. 2672, at 8-11 (refusing to consider the argument that length of re-enrollment bar was “excessive and contrary to regulation,” as the initial determinations “specified in section 498.3(b) do not, under any reasonable interpretation . . . include CMS decisions regarding the severity of the basis for revocation or the duration of a revoked supplier’s re‑enrollment bar”); accord 73 Fed. Reg. 36,448, 36,454 (June 27, 2008) (“[W]hile we believe that providers and suppliers can appeal the revocation determination, we do not believe that providers and suppliers can appeal the duration of the re-enrollment bar for Medicare billing privilege.”).

Petitioner’s reliance on Shah v. Azar is equally misguided.  The court in Shah reviewed CMS’s decision by applying the APA’s arbitrary and capricious standard for judicial review and did not address the scope of review in administrative appeals such as this or

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discuss the role of an ALJ.  See Shah, 920 F.3d at 991, 998.  Additionally, the court stated that “CMS’s decision to impose a [re-enrollment] bar fell within its express regulatory authority.  The regulation gives CMS the discretion to impose a ban . . . ‘depending on the severity of the basis for revocation.’”  Shah, 920 F.3d at 998 (emphasis added) (quoting 42 C.F.R. § 424.535(c)) (deferring to CMS’s assessment of the appropriate sanction).  Thus, the court confirmed that the authority to impose the re-enrollment bar falls within CMS’s discretion which, as noted above, the Board and the ALJ lack authority to review.  See Dave, DAB No. 2672, at 10.

Moreover, contrary to Petitioner’s assertion that CMS provided “no explanation” and no “analysis of the facts” as to why a five-year re-enrollment bar was imposed, RR at 10, P. Reply Br. at 3, CMS explained in its reconsidered determination that the five-year re‑enrollment bar was based on Petitioner’s “non-compliance with Medicare requirements coupled with his actions that led to the suspension of his physician assistant’s license and suspension from the NC Medicaid program,” all of which were detailed in CMS’s reconsidered determination.  RFH at 66 (emphasis added).

Petitioner also cites a Board and two ALJ decisions where, according to Petitioner, “the underlying facts were much more egregious,” but CMS only “imposed a 2-year re‑enrollment bar.”  RR at 10 (citing Thomas Falls, M.D., DAB No. 3056 (2022); Paul D. Orange, M.D., DAB CR5610 (2020); Dr. Eric Thomas, DAB CR5868 (2021)).  As CMS correctly points out, these three cases are of limited consequence because, before November 4, 2019, the maximum re-enrollment bar that CMS could impose was only three years.  See CMS Resp. Br. at 9; Falls, DAB No. 3056, at 1 n.1, 2, 3 (initial revocation determination issued on May 28, 2019); Orange, DAB CR5610, at 2, 5 n.4 (initial revocation determination issued April 23, 2018); Thomas, DAB CR5868, at 2, 4 n.2 (initial revocation determination issued on July 23, 2018).  Section 424.535 was amended, effective November 4, 2019, to establish a re-enrollment bar ranging from one to 10 years for a first-time revocation.  See 84 Fed. Reg. 47,794, 47,826, 47,855 (Sept. 10, 2019).  In this case, the initial revocation determination was issued on July 30, 2021, after the amendment to the regulation.

The ALJ did not err in concluding that an ALJ has no authority to review the length of a re-enrollment bar on appeal.

D.     Neither an ALJ nor this Board has the authority to consider Petitioner’s constitutional due process claim.

Petitioner argues that CMS violated Petitioner’s constitutional right to due process by imposing a five-year re-enrollment bar without explanation.  See RR at 9-11.  Petitioner asserts that “the function of an ALJ is not to ‘rubber stamp’ agency decisions, but rather ensure that agency decisions are within statutory bounds and fair and impartial,” which Petitioner argues the ALJ failed to do.  Id. at 12.

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Petitioner’s due process argument is unavailing.  The Board has repeatedly held that ALJs and the Board are bound by the Medicare enrollment regulations and “lack the authority to overturn, on constitutional grounds, a revocation that was imposed in accordance with the applicable law and regulations.”  Cornelius M. Donohue, DPM, DAB No. 2888, at 8-9 (2018).  Where “the regulatory prerequisites for revocation (both procedural and substantive) are satisfied, as they were here, we must apply the regulations and sustain the revocation.”  Id. (citing Zahid Imran, M.D., DAB No. 2680, at 9 (2016) (stating that the Board may not “[f]ind invalid or refuse to follow Federal statutes and regulations on constitutional grounds” (alteration in original; citation and internal quotation marks omitted))); see also Horace Bledsoe, M.D. & Bledsoe Fam. Med., DAB No. 2753, at 10-11 (2016) (declining to rule on equitable estoppel claim as well as abuse-of-discretion and constitutional claims in upholding revocation under section 424.535(a)(3)), appeal dismissed per stipulation, Bledsoe v. Price, No. 3:17‑cv‑00442 (D.S.C. May 4, 2017).

In Gorovits, the Board applied this principle in declining to review the length of the re‑enrollment bar, rejecting the supplier’s argument that the re-enrollment bar violated the supplier’s due process rights and could be reviewed on constitutional grounds.  See Gorovits, DAB No. 2985, at 5, 6, 18-19.  The Board noted that it may not reverse a lawfully imposed re‑enrollment bar on a claim of constitutional invalidity.  See id. at 18‑19.  Similarly, in this case, Petitioner essentially argues that the administrative appeal process created by Part 498 is constitutionally inadequate because it does not allow Petitioner to challenge the re-enrollment bar.  See RR at 11 (“Due process does not allow an administrative agency to act as the accuser and final decision-maker in an agency adjudication.”).  We cannot consider Petitioner’s argument because it seeks to overturn the re-enrollment bar on constitutional grounds, which we cannot do for the reasons already noted.  See, e.g., Gorovits, DAB No. 2985, at 18-19.  Accordingly, we conclude that we have no basis for reversing or modifying the revocation of Petitioner’s Medicare enrollment on constitutional due process grounds.

E.     The ALJ did not err in concluding that CMS lawfully included Petitioner on its preclusion list.

Petitioner challenges his placement on the CMS preclusion list but only to the extent that he contends his Medicare enrollment should not have been revoked.  See RR at 12 (requesting that Petitioner’s “revocation and placement on the CMS preclusion list be overturned”).  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)(9) and (a)(12), we further affirm the ALJ’s conclusion that CMS lawfully added Petitioner to the preclusion list under 42 C.F.R. §§ 422.2 and 423.100.

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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 re-enrollment 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 7.  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.

Conclusion

We affirm the ALJ’s conclusions that CMS lawfully revoked Petitioner’s Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(9) and (a)(12) and that the length of Petitioner’s re-enrollment bar is not subject to ALJ review.  We further affirm the ALJ’s conclusion that CMS lawfully placed Petitioner on the preclusion list.

ENDNOTES

¹  We cite and apply the regulations in 42 C.F.R. Part 424 that were in effect on July 30, 2021, the date of the initial determination to revoke in this case.  See, e.g., Duke Ahn, M.D., DAB No. 3093, at 1 n.1 (2023) (applying regulations in effect on the date of initial determination to revoke supplier enrollment).

²  The factual information in this section is drawn from the ALJ Decision and the record and is not intended to replace, modify, or supplement the ALJ’s findings of fact.

³  Petitioner’s RFH was filed as a single PDF document with a total of 104 pages and included several exhibits, many of which were part of the record on reconsideration but had not been submitted as marked exhibits.  The ALJ admitted the RFH into the record in its entirety and cited the RFH’s exhibits using the PDF page numbers of the RFH.  See ALJ Decision at 2-3 n.1, 4.  For consistency, we also cite the PDF page numbers when citing the RFH and its exhibits.

⁴  In addition to Petitioner’s RR, Petitioner filed 11 separate exhibits, which are duplicate copies of materials that are in the record of the ALJ proceedings.  It was not necessary to resubmit these materials to the Board, but they are retained as a part of the administrative record of this case.

⁵  In Bajwa, the version of MPIM § 15.27.2.B in effect was Revision 609, effective November 2, 2015.  See MPIM, CMS Pub. 100-08, Ch. 15, § 15.27.2.B (Rev. 609, Effective Nov. 2, 2015), (last visited May 17, 2024), https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R609PI.pdf (“[T]he contractor shall obtain approval of both the revocation and the revocation letter from [CMS] . . . prior to sending the revocation letter.”).

⁶  The district court that affirmed Fayad agreed that the plain language of the Act permits CMS contractors to make an initial determination to revoke Medicare enrollment, and that the supplier’s “assertions that [the contractor] lacked authority to make the initial determination is contrary to provisions of the [] Act.”  Fayad, 803 F. Supp. 2d at 704‑06.  The court noted that section 1842(a) of the Act, which “states that ‘[t]he administration shall be conducted through contracts with medicare administrative contractors under section 1874A,’” permits the Secretary (through CMS) to contract for the “performance of any or all of the functions described” therein, including “other functions as are necessary to carry out the purposes of this title” which, the court held, includes “revoking the [enrollment] of a Medicare supplier.”  Id. at 705 (first alteration in original; internal ellipses, emphasis, and citations omitted).  Revocation, the court thus agreed, “is a program function that is ‘necessary to carry out the purposes’ of the Medicare program and thus may be lawfully delegated to a Medicare contractor pursuant to section 1874(A).”  Id. at 705.

⁷  Prior to November 2019, section 424.535(a) began, “CMS may revoke a currently enrolled provider or supplier’s Medicare billing privileges” and any provider agreement for the listed grounds.  42 C.F.R. § 424.535(a) (2019).  Effective November 4, 2019, “Section 424.535 [was] amended . . . In paragraph (a) introductory text, by removing the term ‘billing privileges’ and adding in its place the word ‘enrollment.’”  84 Fed. Reg. 47,794, 47,854 (Sept. 10, 2019); see id. at 47,840 (“We also proposed to change the term ‘billing privileges’ in the opening paragraph of § 424.535(a) to ‘enrollment.’”).  CMS explained that this change “was to clarify that the revocation reasons in § 424.535(a) apply to all enrolled parties, including suppliers who are enrolled solely to order, certify, refer, or prescribe Medicare-covered Part A or B services, items, or drugs, or to prescribe Part D drugs;” and that “the reasons [for revocation] are not limited to providers and suppliers that have Medicare billing privileges. Thus, for instance, a Part D prescriber’s Medicare enrollment may be revoked if one of the revocation reasons in § 424.535(a) applies.”  Id. at 47,840.  We consequently use the terms enrollment and billing privileges interchangeably, as does CMS, and assign no significance to which is used.

⁸  The Board decisions in Fayad, Bradley, Gorovits, and Bajwa establish the relevant controlling legal precedents here.  While the district court decision in Fayad expressly affirmed the Board’s reasoning, the district court decision itself is not controlling.  See William Garner, M.D., DAB No. 3026, at 11 (2020).

⁹  Paragraph (a)(12) currently authorizes revocation when the provider or supplier “is terminated, revoked or otherwise barred from participation in a State Medicaid program or any other federal health care program,” and the provider or supplier “has exhausted all applicable appeal rights.”  42 C.F.R. § 424.535(a)(12)(i)-(ii).

¹⁰  In Shah v. Azar, the United States Court of Appeals for the Fifth Circuit affirmed the district court, which affirmed our decisions in Mohammad Nawaz, M.D., and Mohammad Zaim, M.D., PA, DAB No. 2687 (2016) and Zille Shah, M.D., and Zille Huma Zaim, M.D., PA, DAB No. 2688 (2016).  See Shah v. Azar, 920 F.3d 987 (5th Cir. 2019), aff’g, Mohammad Nawaz, M.D.  & Mohammad Zaim, M.D., P.A. v. Price; Zille Shah, M.D. & Zille Huma Zaim, M.D., P.A. v. Price, Nos. 4:16cv386 and 4:16cv387, 2017 WL 2798230 (E.D. Tex. June 28, 2017).