Jeffrey K. McIlroy, MD, Inc., DAB No. 3143 (2024)

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

Jeffrey K. McIlroy, MD, Inc. (McIlroy Inc. or Petitioner) appeals the decision of an Administrative Law Judge (ALJ) upholding the effective date of reactivation of Petitioner’s Medicare billing privileges as determined by a contractor for the Centers for Medicare & Medicaid Services (CMS).  Jeffrey K. McIlroy, MD, Inc., DAB CR5795 (2021) (ALJ Decision).  The ALJ upheld the decision to reactivate Petitioner’s billing privileges with an effective date of April 3, 2018, pursuant to 42 C.F.R. § 424.520(d), based on the date Petitioner filed its enrollment application that was subsequently approved by the CMS contractor. 

For the reasons set forth 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.^1,2 See Act §§ 1816, 1842, 1866(j)(1)(A), 1874A; 42 C.F.R. §§ 405.818, 421.5(b), 421.404(c).

To receive payment from Medicare for services furnished to Medicare beneficiaries,

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suppliers must be approved by CMS for “enrollment” in the Medicare program.  See 42 C.F.R. §§ 424.500, 424.505, 424.510.  “Enrollment” is the process that CMS and its contractors use to identify the supplier, validate the supplier’s eligibility to provide services to Medicare beneficiaries, confirm the supplier’s practice location and owners, and grant the supplier Medicare “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.  When applying, the supplier must report its National Provider Identifier (NPI) on the enrollment application.³ Id. § 424.506(b).  Once enrolled, the NPI serves as the supplier’s Medicare billing number and must be included on any claim submitted to Medicare.  See id. §§ 424.505 (noting that the NPI is “use[d] as the Medicare billing number”), 424.506(c).  The supplier is also issued a Provider Transaction Access Number (PTAN), which is a Medicare-only number linked to the supplier’s NPI and is used to authenticate the supplier.⁴  See Richard Weinberger, M.D., and Barbara Vizy, M.D., DAB No. 2823, at 3 (2017).

When a supplier is eligible to receive reimbursement for Medicare services depends on the “effective date” of the billing privileges as provided in 42 C.F.R. § 424.520.  The effective date for billing privileges for a physician or non-physician practitioner organization (like Petitioner) “is the later of – (1) The date of filing of a Medicare enrollment application that was subsequently approved by a Medicare contractor; or (2) The date that the supplier first began furnishing services at a new practice location.”42 C.F.R. § 424.520(d)(1)-(2).  The “date of filing” means the date that the Medicare contractor received the signed enrollment application that satisfies the applicable requirements.  See 73 Fed. Reg. 69,726, 69,766-67 (Nov. 19, 2008); Alexander C. Gatzimos, MD, JD, LLC, DAB No. 2730, at 15-17 (2016).  Additionally, a physician or non-physician organization whose enrollment application has been approved “may retrospectively bill for services” that were provided for up to 30 days before the organization’s “effective date” if “circumstances precluded enrollment in advance of

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providing services to Medicare beneficiaries.”⁵  42 C.F.R. § 424.521(a)(1). 

A supplier may have their billing privileges “deactivated” for various reasons.  “Deactivate” means that the “supplier’s billing privileges were stopped, but can be restored upon the submission of updated information.”  Id. § 424.502 (defining “Deactivate”).  When a supplier’s billing privileges have been deactivated, “[n]o payment may be made for otherwise Medicare covered items or services furnished to a Medicare beneficiary.”  Id. § 424.555(b).  If a supplier furnishes a Medicare-covered item or service while deactivated, any incurred expenses are the responsibility of the supplier.  See id. § 424.555(c).

CMS may “deactivate” the Medicare billing privileges of a supplier for many reasons, including for failure to report “a change in practice location, a change of any managing employee, and a change in billing services,” as well as for not reporting within 30 days    “[a] change in ownership or control.”  42 C.F.R. § 424.540(a)(2). 

Additionally, under 45 C.F.R. § 162.408, CMS, as the administrator of the National Plan and Provider Enumeration System (NPPES),⁶ can “deactivate an NPI upon receipt of appropriate information concerning the dissolution of the health care provider that is an organization, the death of the health care provider who is an individual, or other circumstances justifying deactivation.”  45 C.F.R. § 162.408(c).  See also 69 Fed. Reg. at 3,436, 3,453, 3,469 (publishing NPI final rule and providing that “an NPI is inactivated upon death or dissolution of the health care provider”); 68 Fed. Reg. 60,694, 60,694-95 (Oct. 23, 2003) (providing that the Secretary has delegated to CMS the authority for enforcing the HIPAA provisions related to unique identifiers and operating rules implemented in 45 C.F.R. Part 162); 42 C.F.R. § 424.505 (referring to 45 C.F.R. Part 162 “for information on the [NPI] and its use as the Medicare billing number”). 

To reactivate billing privileges, the supplier must complete and submit a new enrollment application or, when deemed appropriate by CMS, recertify that the enrollment information currently on file with Medicare is correct.  42 C.F.R. § 424.540(b)(1). 

CMS’s determination as to the effective date of a supplier’s billing privileges is an “initial determination” that the supplier may appeal under 42 C.F.R. Part 498.  See 42 C.F.R. § 498.3(a)(1), (b)(15).  A dissatisfied supplier may ask CMS to reconsider the

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effective date and if dissatisfied with the reconsidered determination, may request a hearing before an ALJ.  See 42 C.F.R. § 498.5(f), (l).  Any party dissatisfied with the ALJ decision may request review by the Appellate Division of the Departmental Appeals Board (Board).  See 42 C.F.R. §§ 498.5(l), 498.80.

The deactivation of a supplier’s Medicare billing privileges is not an “initial determination” under 42 C.F.R. § 498.3(b) and therefore not subject to review by an ALJ or the Board.  A supplier whose billing privileges are deactivated may instead file a rebuttal in accordance with 42 C.F.R. §§ 424.545(b) and 405.374(a), by filing a written statement with the CMS contractor.  However, CMS’s ruling on the rebuttal “is not an initial determination and is not appealable.”  42 C.F.R. § 405.375(c).

Factual and Procedural Background⁷

A. The Deactivation of Petitioner’s Medicare Billing Privileges due to the Death of Dr. McIlroy

McIlroy Inc. initially enrolled in the Medicare program in 1998.  CMS Ex. 1, at 2-3, 29.  The evidence in the administrative record indicates McIlroy Inc. provides inpatient and outpatient services to Medicare beneficiaries throughout Oklahoma at five rural hospitals and 18 mental health agencies and employs 24 individual practitioners.  P. Ex. 1 ¶¶ 4‑5; CMS Ex. 5, at 5. 

McIlroy Inc.’s founder, Jeffrey K. McIlroy, M.D. (Dr. McIlroy), died suddenly on January 4, 2018.  P. Ex. 1 ¶ 6; CMS Ex. 5, at 5.  Dr. McIlroy was the sole owner of McIlroy Inc. from its formation until his death.  P. Ex. 1 ¶ 12.  McIlroy Inc. continued providing medical services to Medicare beneficiaries after Dr. McIlroy’s death.  Id. ¶¶ 9‑10, 13.

By letter dated January 26, 2018, CMS’s NPI Enumerator⁸ notified McIlroy Inc. that it had “received information from the Social Security Administration (SSA) indicating that [Dr. McIlroy] is deceased” and that it was requesting “verification of the death of [Dr. McIlroy].”  P. Ex. 2, at 1.  The NPI Enumerator advised McIlroy Inc. that “[t]he NPI Final Rule requires that NPIs be deactivated in the NPPES in the event the health care provider is deceased.”  Id.  The NPI Enumerator instructed McIlroy, Inc. to verify, within

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“30 days from the date of this letter,” that Dr. McIlroy was deceased and if so, to either call the NPI Enumerator or complete and mail the appropriate CMS form (available online) to deactivate the NPI.  Id. On February 5, 2018, Novitas Solutions, Inc. (Novitas), a Medicare contractor, notified McIlroy Inc. that its Medicare enrollment had been deactivated as of January 5, 2018.  CMS Ex. 2, at 1.  Novitas indicated that because Dr. McIlroy, “who was the Sole Owner of the practice, is deceased,” the “Medicare billing privileges of the organization are no longer valid,” and “[a]ny services furnished on behalf of the organization after the date of death of the owning physician/practitioner are not eligible for Medicare reimbursement.”  Id.  Novitas instructed McIlroy Inc. that if the “individual practitioners wish to provide services at the former organization’s practice location,” they must submit a “CMS-855I Application” (Medicare enrollment application) to add the location as a new practice location of the individual practitioners.  Id.  There is nothing in the record indicating that McIlroy Inc. filed a rebuttal in response to the deactivation determination.

B. Petitioner’s New Medicare Enrollment Application and Novitas’s Initial and Reconsidered Determinations

McIlroy Inc.’s Chief Operating Officer (COO) testified that after Dr. McIlroy’s death, Dr. Maria S. Arquisola purchased McIlroy Inc., effective February 22, 2018.  P. Ex. 1 ¶¶ 11‑12.  McIlroy Inc.’s new owner, Dr. Arquisola, completed and signed the CMS-855I Application that same date, but did not mail it to Novitas until April 2, 2018, and Novitas received the application on April 3, 2018.⁹  CMS Ex. 3, at 1, 31, 73, 77.

On May 16, 2018, Novitas notified Dr. Arquisola that it approved the reactivation application, retaining the previous group NPI, issuing a new PTAN for McIlroy Inc., and indicating the effective date for billing privileges was March 4, 2018.¹⁰ See Request for ALJ Hearing (RFH) at 47‑48.¹¹  Novitas also advised that if McIlroy Inc. disagreed with the effective date, it could request reconsideration.  See RFH at 51-52. 

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Dissatisfied with the effective date, Petitioner filed a request for reconsideration requesting that Novitas change the effective date of its billing privileges to January 5, 2018.  CMS Ex. 5, at 5.  Petitioner explained that despite Dr. McIlroy’s death, “we felt and continue to feel an ethical and moral responsibility in providing continuity of care to our Medicare patients.”  Id.

On September 27, 2018, Novitas issued its reconsidered determination denying Petitioner’s request for an earlier effective date.  CMS Ex. 6, at 2, 4.  Novitas concluded that “[b]ased on the CMS-855I enrollment application being received on April 3, 2018, [] the effective date of Medicare billing privileges is April 3, 2018,” with “a retrospective effective date of billing of March 4, 2018,” in accordance with 42 C.F.R. § 424.521(a).  Id. at 4.

C. The ALJ Proceedings and Decision

Petitioner timely requested an ALJ hearing to appeal the reconsidered determination.  ALJ Decision at 2; see RFH.  Consistent with the ALJ’s prehearing order, the parties exchanged pre-hearing briefs; CMS moved for summary judgment, which Petitioner opposed.  ALJ Decision at 2.  Additionally, Petitioner filed discovery requests in the form of interrogatories and requests for the production of documents as well as a request for the issuance of a subpoena, all of which CMS opposed.  Id.  Petitioner also filed a Request for Status Conference and Renewed Combined Motion for Hearing and Request for Order Requiring Discovery From CMS, which the ALJ denied by Order dated September 30, 2019.  See ALJ Denial of Req. for Status Conf./Renewed Request for Discovery.  The ALJ admitted all of CMS’s six proposed exhibits into the record without objection.  ALJ Decision at 2.  The ALJ also admitted into the record Petitioner’s three proposed exhibits.  Id.  Although CMS moved for summary judgment, the ALJ decided the case on the written record and not under the summary judgment standard.  Id.

Preliminarily, the ALJ denied Petitioner’s discovery requests.  Id. at 2-3.  The ALJ determined “[t]he regulations governing these proceedings do not provide for the sort of freewheeling discovery mechanisms available in some court proceedings,” and the only available discovery tool “is the subpoena, but only if the party shows that its issuance is reasonably necessary for the full presentation of a case.”  Id. (citations and internal quotation marks omitted).  The ALJ first determined that Petitioner was “not entitled to responses to interrogatories or the production of documents.”  Id. at 3.  The ALJ further denied “Petitioner’s subpoena request because it does not meet any of the regulatory criteria” in 42 C.F.R. § 498.58, and “seeks information regarding the contractor’s deliberations here, which are irrelevant and likely protected by the deliberative process privilege.”  Id. at 3.  The ALJ further determined that a hearing was unnecessary because CMS did not request to cross‑examine Petitioner’s listed witness.  Id.

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Before the ALJ, Petitioner argued that CMS improperly deactivated its Medicare billing privileges and erroneously determined the effective date of its reactivation to be April 3, 2018.  RFH at 6-8; Petitioner’s Combined Pre-Hearing Brief and Response in Opposition to CMS’ Motion for Summary Judgment and Rule 56(d) Motion (P. ALJ Br.) at 7-13.  Petitioner argued that there was no statutory or regulatory basis for deactivating its billing privileges, that CMS failed to follow the Medicare Program Integrity Manual (MPIM) provision that provides instructions for terminating or revoking Medicare enrollment (for deceased sole owners based on the practice automatically being dissolved for purposes of Medicare enrollment),¹² which is a different process from deactivation, and that Dr. McIlroy’s death did not dissolve or impact Petitioner’s legal entity status in any way.  See P. ALJ Br. at 8-13.  Petitioner also argued that “the appropriate effective date would be January 5, 2018 (for the Practice) and February 22, 2018 (for Dr. Arquisola) based upon the date each respectively first began furnishing services at a new practice location under section 424.520(d)(2).”  RFH at 6-7 (internal quotation marks omitted); see also P. ALJ Br. at 13.  Alternatively, Petitioner argued the effective date for both the Practice and Dr. Arquisola should be February 22, 2018, based on the date of the application, not its April 3, 2018 receipt, which Petitioner asserts was delayed by the contractor’s processing procedures.  RFH at 7.

The ALJ acknowledged Petitioner’s deactivation argument but concluded, “I have no authority to review a deactivation” and proceeded to the effective date issue.  ALJ Decision at 4.  Regarding the effective date, the ALJ concluded that “[b]ecause Petitioner filed its subsequently-approved enrollment application on April 3, 2018, CMS properly granted its Medicare enrollment effective that date [and] CMS was also authorized to allow the practice to bill retrospectively” under section 424.521(a)(1).  Id. at 5.  The ALJ further determined that “I may not grant Petitioner an earlier effective date based on any equitable or policy arguments.”  Id.

D. Arguments Before the Board

Petitioner timely appealed to the Board.  

At the heart of Petitioner’s appeal is its claim that CMS “wrongly withheld approximately $157,000 of reimbursable charges” for services Petitioner “provided to Medicare patients between January 5, 2018, and March 4, 2018”—the period that Petitioner’s billing privileges were deactivated.  Request for Review (RR) at 1;¹³ see also

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id. at 2, 6-8, 17-18, 20-21; Petitioner’s Reply to CMS’s Response to Request for Review of the ALJ’s Decision (P. Reply Br.) at 1.  To that end, Petitioner makes six primary arguments as to how the ALJ erred and why the ALJ Decision should be overturned:

• the ALJ erred by improperly narrowing the scope of review and not considering the legitimacy of the deactivation determination. See RR at 2, 8-16.
• the ALJ erred in refusing to consider allegedly “improper and confusing direction” from CMS “that unnecessarily delayed McIlroy [Inc.’s] effective date” and thereby affirming CMS’ determination of the effective enrollment date. See RR at 17; P. Reply Br. at 2-3.
• the ALJ erred in denying Petitioner’s subpoena and discovery requests. See RR at 2, 17-18.
• the ALJ erred in denying its request for a hearing and deciding the case on the written record. See RR at 18.
• the ALJ’s approval of CMS’ unauthorized conduct based upon CMS’ own interpretation of the clear and unambiguous regulations is unconstitutional. See RR at 2, 19-20.
• the ALJ erred by refusing to consider the Petitioner’s equitable arguments regarding the impact of CMS’ actions. Id.

In response, CMS asserts the ALJ’s decision was based on substantial evidence in the record and correct conclusions of law.  See CMS’ Response to Petitioner’s Request for Review of the ALJ’s Decision (CMS Resp. Br.) at 5.  CMS contends “the Medicare contractor properly established Petitioner’[s] effective enrollment date as March 4, 2018, allowing Petitioner to bill for Medicare services dating 30 days prior to the receipt of its application on April 3, 2018, per 42 C.F.R. § 424.521(a).”  Id. at 5.  CMS also asserts the ALJ correctly determined that “neither an ALJ nor the Board have the authority to review CMS’s decision regarding deactivation.”  Id. at 6-7.  CMS further argues the ALJ correctly denied Petitioner’s discovery requests and properly decided the case based on the written record, and Petitioner’s constitutional and equitable arguments are unavailing.  Id. at 7-10.

Standard of Review

The Board’s standard of review on a disputed factual issue is whether the ALJ decision is supported by substantial evidence; the standard of review on a disputed issue of law is whether the ALJ’s decision is erroneous.  Guidelines – Appellate Review of Decisions of Administrative Law Judges Affecting a Provider’s or Supplier’s Enrollment in the Medicare Program (Guidelines), accessible at https://www.hhs.gov/about/agencies/dab/different-appeals-at-dab/appeals-to-board/guidelines/enrollment/index.html?language=en.   

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Analysis

Upon consideration of the record and the arguments of the parties, we agree with the ALJ that the deactivation is not an initial determination and therefore not reviewable on appeal.  Additionally, the ALJ’s decision that the effective date of reactivation of Petitioner’s billing privileges is April 3, 2018, is supported by substantial evidence and free of legal error.  We also find that neither the ALJ’s denial of Petitioner’s subpoena and discovery requests nor the ALJ’s decision of the case on the written record without a hearing was erroneous or an abuse of discretion.  We further conclude that neither an ALJ nor the Board has the authority to consider Petitioner’s constitutional and equitable claims.  We therefore affirm the ALJ Decision.

A. The ALJ’s decision that the deactivation of Petitioner’s Medicare billing privileges was not reviewable is free of legal error.

Petitioner argues that CMS unlawfully deactivated Petitioner’s billing privileges, and the ALJ erred by not reviewing the legitimacy of the deactivation.  See RR at 2, 8-16.  Petitioner argues the regulations do not authorize CMS to retroactively deactivate a supplier’s enrollment upon the death of its sole owner, but instead require that a supplier report updated information to CMS within 30 days of a change of ownership or 90 days of a change of control, which Petitioner argues was done in this case.  Id. at 9-10.  Similarly, Petitioner argues that there was no regulatory basis for the deactivation because Dr. McIlroy’s death “did not dissolve or otherwise negatively impact the [] legal status” of McIlroy Inc. under Oklahoma statute, and the change of ownership did not occur until Dr. Arquisola’s February 22 purchase of McIlroy Inc.  Id. at 11-13, 16 (emphasis omitted).  Petitioner further argues that CMS failed to follow the MPIM, which instructs CMS to initiate revocation procedures—a different process from deactivation—upon the death of a sole owner, and regardless, CMS did not satisfy the conditions for revocation.  Id. at 13-16.

In its brief, CMS asserts:

[T]he propriety of the deactivation is not at issue and it is undisputed that CMS did not receive a reactivation enrollment application from Petitioner until April 3, 2018. Following all applicable regulations and procedures, CMS then properly determined Petitioner’ effective reenrollment date based on the date it received its application and granted a 30-day retrospective billing window.  Therefore, CMS’s effective date determination, and the ALJ’s decision affirming it, should be upheld.

CMS Resp. Br. at 1-2.

As an initial matter, we reject Petitioner’s assertions that this case involves a revocation,

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and that Petitioner’s “Medicare enrollment” was “terminated,” RR at 5, because Petitioner’s deactivation was not a revocation or termination.  Petitioner repeatedly incorrectly refers to the deactivation as a “termination” and asserts its “Medicare enrollment” was wrongly terminated.  See, e.g., RR at 16 (“The ALJ Erred in Failing to Consider CMS’s Improper Retroactive Termination of [Petitioner’s] Medicare Enrollment as of January 5, 2018.” (emphasis omitted)).  A “termination of [Petitioner’s] Medicare enrollment” did not occur because this case does not involve a revocation.  “Revocation of billing privileges is distinguishable from deactivation of billing privileges.”  Anthony Del Piano, M.D., DAB No. 3096, at 21 (2023).  A revocation “means that the . . . supplier’s billing privileges are terminated.”  42 C.F.R. § 424.502 (emphasis added) (defining “Revoke/Revocation”).  Deactivation means that a supplier's billing privileges “can be restored upon” (not before) the supplier’s submission of updated information.  Michael B. Zafrani, M.D., DAB No. 3075, at 10 (2022) (emphasis in original) (quoting 42 C.F.R. § 424.502).

Petitioner’s challenge also is without merit because neither an ALJ nor this Board has the authority to review a deactivation.  In Willie Goffney, Jr., M.D., DAB No. 2763 (2017), 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), the Board held that a “[d]eactivation is not appealable and is not reviewable.”  Goffney, DAB No. 2763, at 3-5 (italics removed).  In Goffney, the supplier-physician sought to challenge his deactivation by arguing that the deactivation letter was issued in error.  Id. at 5.  The Board determined that 42 C.F.R. § 498.3(b) provides for appeal rights to an ALJ and then Board review for only certain specified “initial determinations” by CMS, and only after unfavorable reconsiderations are issued for those initial determinations.  Id. at 5.  The Board found that the deactivation of billing privileges is not listed as an “initial determination” under section 498.3(b).  Id. at 5.  The Board concluded that because a deactivation is not an initial determination, there is no appealable right to a reconsideration, and without the reconsideration, neither the ALJ nor the Board has jurisdiction to consider the deactivation.  See id. at 4-5.  The Board explained that this conclusion was reinforced by 42 C.F.R. § 424.545(b), which does not provide a right to appeal but states only that a “supplier whose billing privileges are deactivated may file a rebuttal,” which the Board held “is not itself an appeal” under the regulations.  Id. at 5.  The Board added that “neither section 424.545(b) nor any other regulation provides appeal rights from the contractor’s deactivation determination or any rebuttal determination.”  Id. 

The Board has applied the reasoning of Goffney to reject attempted challenges to deactivations on numerous occasions.  See, e.g., Gregory J. Frazer, Au.D., Ph.D., DAB No. 3038, at 10-11 (2021) (rejecting the supplier’s argument that their deactivation is appealable under section 498.3(b)(17) and explaining “a deactivated supplier has only the right to file a rebuttal at the contractor level, not an appeal or request for ALJ review”); Urology Group of NJ, LLC, DAB No. 2860, at 6 (2018) (“The regulations do not grant

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suppliers the right to appeal deactivations.”); Decatur Health Imaging, LLC, DAB No. 2805, at 10 (2017) (“ALJs (and the Board) only have jurisdiction to review the Secretary’s initial determinations, and CMS’s decision to deactivate billing privileges is not an initial determination.” (internal quotations marks omitted)).

Urology Group is notably analogous to the present case.  In Urology Group, the contractor deactivated the billing privileges of the supplier (a medical group) after one of the supplier’s owners died, and the supplier failed to timely update its enrollment record by removing the deceased owner as instructed.  Urology Group, DAB No. 2860, at 2-3.  The supplier sought to challenge the circumstances surrounding the deactivation by arguing that the deactivation regulations do not authorize a “gap period” for the reimbursement of covered services and that deactivation was not valid because the supplier did not receive the contractor’s previous letter notifying the supplier of its intent to deactivate if the enrollment record was not timely updated.  See id. at 6-7.  Citing Goffney, the Board rejected the supplier’s arguments, explaining that “[t]he regulations do not grant suppliers the right to appeal deactivations,” so whether the supplier was notified of the deactivation was “outside the Board’s authority to review.”  Id.  The Board further determined that the supplier’s arguments that the deactivation created an unlawful “gap period” for the reimbursement of services rendered between the deactivation and reactivation were essentially claims for Medicare payment, which “are not cognizable in this forum and may be appealed only after submitting a claim and only through the process set out in 42 C.F.R. Part 405.”  Id. at 7 (emphasis in original) (internal quotation marks omitted) (quoting Goffney, DAB No. 2763, at 6).

Decatur Health also has instructive similarities to the present case.  In Decatur Health, the contractor deactivated the billing privileges of an independent diagnostic testing facility (IDTF) after a part owner (a physician who held a small ownership stake in the IDTF) died, and the IDTF failed to timely report its change in ownership as instructed by the contractor.  Decatur Health, DAB No. 2805, at 3.¹⁴  Before the Board, the IDTF made several arguments including that the deactivation was not legitimate because the IDTF relied on incorrect information from CMS on how to report a change in ownership following the death of one of its owners, which delayed its reporting of the change to CMS.  See id. at 9-10.  Citing Goffney, the Board concluded that “[t]he ALJ did not err in declining to review the circumstances that [the IDTF] claims led to the deactivation of its billing privileges” because deactivations are not appealable initial determinations.  Id. at 10.  The Board explained that “the circumstances that led to the deactivation of [the IDTF’s] billing privileges are not relevant to the narrow issue before us,” which is only whether the effective date of the IDTF’s reactivated billing privileges is correct.  Id.

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Here, Petitioner does not even discuss these Board decisions, much less proffer reasons to question the Board’s reasoning in them.  Petitioner is challenging the validity of its deactivation, which under Goffney and its progeny is not appealable and is not reviewable.  See, e.g., Goffney, DAB No. 2763, at 4-5.  Like the supplier in Urology Group and the IDTF in Decatur Health, Petitioner’s challenge to its deactivation that resulted from its owner’s death is in vain.  See Urology Group, DAB No. 2860, at 2-3, 6‑7; Decatur Health, DAB No. 2805, at 3, 9‑10.  We do not have the authority to review a deactivation because a deactivation is not an appealable initial determination under 42 C.F.R. § 498.3(b).  See, e.g., Goffney, DAB No. 2763, at 4-5.  Additionally, as explained above, a deactivated supplier has only the right to file a rebuttal at the contractor level, which is a right Petitioner does not acknowledge or indicate it tried to exercise, and regardless, “[a] rebuttal is not itself an appeal.”  Goffney, DAB No. 2763, at 5; see 42 C.F.R. §§ 424.545(b), 405.374(a), 405.375(c).

Unable to cite any authority permitting review of a deactivation decision by an ALJ or the Board (because there is none), Petitioner attempts to recharacterize the deactivation as a termination or revocation (discussed above), and makes general policy arguments that we “should not turn a blind eye to CMS’s abuse and exploitation of” McIlroy Inc., and “insulat[ing] CMS’ deactivation procedures and determinations from review defies all notions of fairness and renders the applicable federal regulations meaningless.”  RR at 9.  To the contrary, “to consider arguments that a contractor improperly” deactivated a supplier’s billing privileges “would make a nullity of the prohibition of appeals relating to” deactivations and “would amount to the Board or the ALJ reviewing the validity of the deactivation without any regulatory or other source of such authority.”  Frazer, DAB No. 3038, at 11 (internal quotation marks and citations omitted) (quoting Chaplin Liu, M.D., DAB No. 2976, at 8 (2019)). 

Importantly, suppliers do have the right to appeal and ultimately to seek ALJ and Board review for initial determinations regarding the effective date of Medicare billing privileges.  See 42 C.F.R. §§ 498.3(b)(15), 498.5(l); see also Goffney, DAB No. 2763, at 5; Urology Group, DAB No. 2860, at 6.  Thus, the only determination the ALJ had authority to review was the April 3, 2018 effective date of reactivation of Petitioner’s billing privileges established in the reconsidered determination, which Petitioner could then appeal to the Board.  See 42 C.F.R. §§ 498.3(b)(15), 498.5(l); see also Goffney, DAB No. 2763, at 5; Urology Group, DAB No. 2860, at 6. 

Petitioner’s assertion that CMS “wrongly withheld approximately $157,000 of reimbursable charges” also provides no basis for relief.  See RR at 1.  Petitioner has not provided any evidence of any service provided to any Medicare beneficiary or any claim submitted to Medicare for reimbursement other than a blanket statement from its COO that it “provided approximately $157,000 worth of reimbursable medical services to Medicare patients.”  P. Ex. 1 ¶ 13.  Even if that is true, Petitioner ignores the regulations that state “[n]o payment may be made for otherwise Medicare covered items or services

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furnished to a Medicare beneficiary” if the supplier’s billing privileges are deactivated and that any expenses incurred during the deactivation are the supplier’s responsibility.  See 42 C.F.R. § 424.555(b)–(c).  Additionally, like the supplier in Urology Group that was dissatisfied with the “gap period” in reimbursements as a result of the deactivation, Petitioner’s claimed entitlement to “$157,000 of reimbursable charges,” is a dispute about “Medicare claim reimbursement [that is] not cognizable in this forum and may be appealed only after submitting a claim and only through the process set out in 42 C.F.R. Part 405.”¹⁵ See Urology Group, DAB No. 2860, at 6-7 (emphasis in original) (internal quotation marks omitted) (quoting Goffney, DAB No. 2763, at 6); accord Howard M. Sokoloff, DPM, MS, Inc., DAB No. 2972, at 6 (2019). 

Accordingly, we affirm the ALJ’s determination that the deactivation of Petitioner’s Medicare billing privileges was not reviewable.

B. The reactivation effective date established in the reconsidered determination and affirmed by the ALJ is supported by substantial evidence and free of legal error.

Having determined that Petitioner has no right to appeal the deactivation, we consider the only issue that is properly before us:  whether the April 3, 2018 effective date of reactivation of Petitioner’s billing privileges established in the reconsidered determination and affirmed by the ALJ is correct.  We conclude that it was, and Petitioner’s arguments do not persuade us otherwise. 

1. The effective date of reactivation is the date that the Medicare contractor receives a signed enrollment application that the Medicare contractor is able to process to approval.

The Board has long held that a reactivation application is treated as an initial enrollment application, and we are to apply 42 C.F.R. § 424.520(d) to determine the effective date for the reactivation of a supplier’s Medicare billing privileges.  See, e.g., Sokoloff, DAB No. 2972, at 6-7; Urology Group, DAB No. 2860, at 7-13; Goffney, DAB No. 2763, at 7; Frazer, DAB No. 3038, at 9-10. 

Section 424.520(d) provides that the effective date for billing privileges for physicians and physician organizations “is the later of – (1) The date of filing of a Medicare enrollment application that was subsequently approved by a Medicare contractor; or (2) The date that the supplier first began furnishing services at a new practice location.”  42 C.F.R. § 424.520(d)(1)–(2).  In the preamble to the rulemaking that adopted section 424.520, CMS explained that “date of filing” means “the date that the Medicare . . .

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contractor receives a signed Medicare enrollment application that the Medicare . . . contractor is able to process to approval.”  73 Fed. Reg. 69,726, 69,766-67 (Nov. 19, 2008).  The Board applies that interpretation when determining the effective date of a supplier’s billing privileges under section 424.520(d).  See e.g., Gatzimos, DAB No. 2730, at 5-17 (undergoing an extensive review of the rulemaking history, interpretative guidance, and context of section 424.520(d) to conclude that “date of filing” continues to mean the date an application is received by the contractor).  Additionally, suppliers who have “met all program requirements” may “retrospectively bill” Medicare for services for up to 30 days before the supplier’s “effective date if circumstances precluded enrollment in advance of providing services to Medicare beneficiaries.”  42 C.F.R. § 424.521(a)(1).

Petitioner asserts that on March 15, 2018, McIlroy Inc. “follow[ed] CMS’ direction and recommendation” and submitted a form CMS-855I application online using the Provider Enrollment, Chain and Ownership System (PECOS).  RR at 5 (citing P. Ex. 3).  There is no evidence in the record of an online application being filed.  The initial letter from CMS, dated January 26, 2018, provided explicit direction as to how to deactivate the deceased provider’s NPI, by either calling the NPI Enumerator, or mailing a hard copy NPI Application/Update Form to the address listed in the letter.  See P. Ex. 2, at 1.  Petitioner did neither.  The letter from Novitas, dated February 5, 2018, which the COO alludes to, did provide directions to the individual practitioners, not the organization itself, to use the online form or the paper form to add the former organization’s practice location as a new practice location for their existing practice should they desire to provide services at the former organization’s practice location.  See P. Ex. 3 ¶ 3; CMS. Ex. 2, at 1.  The record contains no other communications from CMS until the reactivation letter, dated May 16, 2018.  While Petitioner may have misunderstood the language in the letter from Novitas, the ALJ’s reliance on the only application in the record that was processed to approval to affirm the effective date was not erroneous.  See Sandeep Gupta, M.D., DAB No. 3088, at 9 (2023) (citing Decatur Health, DAB No. 2805, at 7 (“The Board has held that ‘the plain language’ of the effective date regulation []at section 424.520(d) . . . requires that the effective date be based on an application that was ‘processed to approval’ by the Medicare contractor.” (quoting Karthik Ramaswamy, M.D., DAB No. 2563, at 6 (2014) (“[U]nder the plain language of the regulation, neither an ALJ nor the Board may change an effective date to the date of receipt of an earlier application that . . . was not processed to approval.” (emphasis omitted), aff’d, Ramaswamy v. Burwell, 83 F. Supp. 3d 846 (E.D. Mo. 2015)))). 

Based on the governing regulations, the Board’s prior holdings, and our review of the record in this case, we conclude that the ALJ’s decision upholding CMS’s determination of the April 3, 2018 effective date of reactivation of Petitioner’s billing privileges is supported by substantial evidence and free from legal error.  The record establishes that Petitioner’s new owner completed a reactivation application and mailed it to Novitas, which received the application on April 3, 2018, and subsequently approved it.  CMS Ex. 3, at 1, 73, 77; CMS Ex. 4, at 1.  Properly applying section 424.520(d) to the facts

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established by the evidence, the ALJ did not err in determining that April 3, 2018, is the effective date for reactivation of Petitioner’s billing privileges. 

2. We do not consider Petitioner’s new assertions that the proper effective date for Petitioner’s reactivated billing privileges is January 5, 2018, or in the alternative, February 13, 2018.

Petitioner additionally contends that the ALJ erred by affirming CMS’s effective date determination because the proper effective date of Petitioner’s enrollment under 42 C.F.R. § 424.540(c) is January 5, 2018, or in the alternative, February 13, 2018, 30 days before the Petitioner purportedly submitted the online enrollment application.  See RR at 17; P. Reply Br. at 2-3.  Petitioner’s arguments in support of these two effective dates are without merit.

Before the ALJ, Petitioner argued that similar dates should be the effective date, relying on 42 C.F.R. § 424.520(d)(2)—which sets the effective date to the date the supplier “first began furnishing services at a new practice location”—because after the death of Dr. McIlroy, “the individual providers began providing services at [a] new location on January 5, 2018,” or in the alternative, “Dr. Arquisola began providing services at [a] new location on February 22, 2018.”  P. ALJ Br. at 14; see also RFH at 6-7 (arguing that the proper effective date should be based upon the date each “respectively ‘first began furnishing services at a new practice location’ under section 424.520(d)(2)”).  

Before the Board, Petitioner again asserts that the “correct” effective date should be January 5, 2018, but Petitioner now asserts a “new” rationale, that “[t]he deactivated provider or supplier is not applying for new enrollment and, therefore, the ALJ’s reliance on section 424.520 is in error” and cites Jean-Claude Henry, M.D., DAB CR4627 (2016), in support of its position.  P. Reply Br. at 2-3 (emphasis omitted).  Petitioner also asserts a “new” alternative effective date of February 13, 2018, 30 days prior to an online application purportedly submitted.  RR at 17, 18.  

Here, Petitioner again conflates the effective date of billing privileges (reactivation) and the separate determination of the retrospective billing period, which are distinct determinations.  Petitioner also continues to conflate “deactivation” and “revocation” for the purpose of challenging the effective date when Petitioner’s deactivation resulted in a temporary suspension of Medicare billing privileges but did not terminate Petitioner’s Medicare enrollment status as a supplier of services to Medicare beneficiaries under section 424.540(c).  See P. Reply Br. at 2-3.  Additionally, Petitioner’s reliance on the ALJ decision in Henry is erroneous as that decision was not appealed to the Board, and decisions by ALJs are not precedential, do not bind the Board, and are relevant “only to the extent [their] reasoning is on point and persuasive.”  See Frederick Brodeur, M.D., DAB No. 2857, at 13 (2018) (citations omitted).  Indeed, in Brodeur, the Board specifically stated that it did “not find the reasoning applied by the ALJ in . . . Henry

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persuasive.”  Brodeur, DAB No. 2857, at 13.  As stated, the ALJ determined, and we have affirmed, the reactivation application is treated as an initial enrollment application, and we apply 42 C.F.R. § 424.520(d) to determine the effective date for the reactivation of a supplier’s Medicare enrollment.  See, e.g., Sokoloff, DAB No. 2972, at 6-7; Urology Group, DAB No. 2860, at 7-13; Goffney, DAB No. 2763, at 7; Frazer, DAB No. 3038, at 9-10.  Petitioner does not discuss these Board decisions, or proffer reasons to question the Board’s reasoning in them.      

More pertinently, Petitioner did not raise these new arguments before the ALJ.  See Guidelines at “Completion of the Review Process” ¶ (a) (“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.”); accord Goffney, DAB No. 2763, at 7; Richard Weinberger, M.D., and Barbara Vizy, M.D., DAB No. 2823, at 22 (2017).

C. The ALJ’s denial of Petitioner’s subpoena and discovery requests was not erroneous or an abuse of discretion.

Petitioner argues the ALJ erred by denying Petitioner’s requests for discovery in the form of interrogatories and requests for the production of documents and the issuance of a subpoena to address questions regarding CMS’s deactivation of Petitioner’s Medicare enrollment and effective date determination.  See RR at 2, 17-18.  Petitioner asserts “[t]he Regulations do not prohibit discovery, but limit it to ‘clearly relevant material’” and “do not provide that a subpoena is the only authorized method of pre-hearing discovery.”  Id. at 17 (emphasis omitted).

We disagree.  The ALJ correctly cited to Michael Turano, M.D., DAB No. 2922, at 14 (2019), which clarified that a subpoena is the only discovery tool available to parties in proceedings arising under 42 C.F.R. Part 498.  ALJ Decision at 3.

The regulations in 42 C.F.R. Part 498 that govern this appeal do not provide for pre-hearing discovery as it is available in federal courts through the application of the Federal Rules of Civil Procedures.  “The part 498 regulations give the ALJ one and only one tool – namely the subpoena – for compelling the production of relevant evidence that the parties have not voluntarily produced.”  Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375, at 32 n.16 (2011); see also Ridgeview Hospital, Ruling No. 2015-1 (Jan. 12, 2015) denying reconsideration of DAB No. 2593 (stating that Part 498 regulations “do not provide for the sort of freewheeling discovery mechanisms available in some court proceedings” and “merely permit an ALJ to issue subpoenas” under section 498.58); S.A. Brooks, DPM, DAB No. 2615, at 17, n.9 (2015) (although “traditional discovery procedures are not available in a Part 498 proceeding, a party in such a proceeding may request a subpoena identifying documents to be produced” under section 498.58). 

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Turano, DAB No. 2922, at 14.  Part 498 gives ALJs only one means—the issuance of a subpoena—to compel the production of relevant evidence that the parties themselves have not produced for admission into the record.  Therefore, under the regulations governing this appeal, Petitioner was not allowed discovery in the form of interrogatories and requests for the production of documents.  Accordingly, the ALJ did not err in denying Petitioner’s request for this type of discovery.

We next consider the ALJ’s denial of Petitioner’s request for a subpoena.  The governing regulation, 42 C.F.R. § 498.58, states that an ALJ “may issue subpoenas if they are reasonably necessary for the full presentation of a case.”  42 C.F.R. § 498.58(a).  The regulation requires the party requesting the subpoena to identify the witness to be produced; describe “with sufficient particularity” the witness’s address or location; specify the pertinent facts the party expects to establish through the witness testimony; and indicate why those facts could not be established without use of a subpoena.  42 C.F.R. § 498.58(c). 

In its motion for a subpoena, Petitioner attempted to satisfy the regulatory requirements by simply stating the requirements “are provided in Petitioner’s First Set of Discovery Requests.”  Petitioner’s Response to CMS’ Objections to Discovery Requests and Motion to Issue Subpoena, at 6.  Before the Board, Petitioner only asserts that “CMS has not identified the specific persons” and “has not identified the locations of these persons,” so Petitioner cannot satisfy the regulatory requirements.  RR at 18.  However, the burden is on the party requesting the subpoena under section 498.58 to provide the information necessary for the issuance of a subpoena.  See Turano, DAB No. 2922, at 14-16.  We agree with the ALJ that Petitioner’s subpoena request “does not meet any of the regulatory criteria, [and] does not even identify a witness, much less describe with particularity an address or location.”  ALJ Decision at 3.

We also agree that Petitioner has not shown that issuing a subpoena is reasonably necessary for the full presentation of its case under section 498.58(a).  “To determine whether the evidence sought is ‘reasonably necessary for the full presentation of a case,’ we would need to ask what issue(s) was (were) properly before the ALJ for her resolution.”  Turano, DAB No. 2922, at 15.  The only issue before the ALJ was whether the April 3, 2018 effective date of reactivation of Petitioner’s billing privileges established in the reconsidered determination was correct.  ALJ Decision at 3‑5.  As the ALJ concluded, pursuant to 42 C.F.R. §§ 424.520(d) and 424.521(a)(1), “Petitioner filed its subsequently-approved enrollment application on April 3, 2018, and its Medicare reactivation enrollment can be no earlier than that date, although it may retrospectively bill for services provided up to thirty days prior to its enrollment if certain criteria are met.”  Id. at 3 (bold and italics omitted).¹⁶  Petitioner seeks to use the subpoena to

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determine “whether CMS followed proper procedures and was authorized to retroactively terminate [Petitioner’s] Medicare enrollment,” which was not an issue properly before the ALJ.  RR at 18. 

Finally, the ALJ also found that Petitioner’s “request seeks information regarding the contractor’s deliberations here, which are irrelevant and likely protected by the deliberative process privilege. . . . [T]he non-deliberative information Petitioner seeks has either been provided or is irrelevant.”  ALJ Decision at 3.  Petitioner has not provided any legal authority to show the ALJ’s evidentiary ruling was incorrect.  Petitioner’s only argument is that CMS has not “identified which documents are privileged from discovery,” and “[t]he bare assertion the deliberative process privilege might apply is insufficient.”  RR at 18.  As we have explained, “[t]he ALJ has broad discretionary authority over evidentiary matters[, and] [w]e defer to the ALJ’s evidentiary rulings in the absence of a compelling reason not to do so.”  Thomas Falls, M.D., DAB No. 3056, at 18 (2022) (citing HeartFlow, Inc., DAB No. 2781, at 19 (2017)).  Accordingly, the ALJ did not err or commit an abuse of discretion in denying Petitioner’s subpoena and discovery requests.

D. The ALJ did not err by deciding this case on the written record without a hearing.

Next, Petitioner argues the ALJ erred in denying Petitioner’s request for a hearing and deciding the case on the written record.  See RR at 2, 19.  Petitioner asserts that “CMS had failed to satisfy its burden at summary judgment” and that “[t]here are multiple open fact and legal questions.”  Id. at 19.  Petitioner also asserts that “CMS’ refusal to identify any witnesses . . . is an improper basis” for the ALJ to conclude “there are no relevant witnesses,” and the ALJ “incorrectly concluded that [Petitioner] only listed one witness” because Petitioner “designated CMS’ representatives, to be identified through discovery, to testify” as witnesses.  Id.

We find no merit to Petitioner’s argument, which misconstrues the ALJ proceedings and decision.  The ALJ did not decide this case on summary judgment or conclude that there were no disputed issues of material fact.  Although CMS moved for summary judgment, the ALJ decided the case on the written record and not under the summary judgment standard.  ALJ Decision at 2.  The ALJ also determined that an in-person hearing was unnecessary because Petitioner only identified a single witness, its COO, and CMS did not request to cross‑examine the witness.  Id.  In making that determination, the ALJ considered the parties’ respective arguments, considered the evidence presented by both parties, and ultimately resolved the case in favor of CMS.  See id. at 3-5.

“Although disputed issues of material fact preclude summary judgment, they do not preclude a decision on the written record.”  Five Star Healthcare, LLC, DAB No. 3089, at 8 (2023).  In the ALJ’s Acknowledgment and Pre-Hearing Order, the ALJ instructed

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the parties to list any proposed witnesses and to submit their written direct testimony.  Acknowledgment and Prehearing Order at 3, 5 (¶¶ 4, 8).  The ALJ also informed the parties that an in-person hearing, as opposed to a review based on the written record, would be necessary only if a party filed written direct testimony of a witness and the opposing party requested cross-examination.  Id. at 6 (¶ 10).  Thus, the sole purpose of convening an in-person hearing would be for cross-examination.  Id.  “Deciding [a] case based on the written record, including any written direct testimony, is consistent with due process so long as in-person cross-examination is available.”  George Yaplee Med. Ctr., DAB No. 3003, at 5 (2020) (collecting cases); see also Igor Mitreski, M.D., DAB No. 2665, at 7 (2015) (concluding that not holding an in-person hearing does not generally pose a due process concern where neither party seeks to cross-examine any witness for whom the opposing party has submitted written direct testimony).  Where no witness testimony is proffered, or all witness testimony is submitted in writing and no cross-examination is sought, there is no need to convene an in-person hearing.  George Yaplee, DAB No. 3003, at 5.

Here, CMS did not proffer the written direct testimony of any witness.  Petitioner asserts that “CMS’ refusal to identify any witnesses . . . is an improper basis” for the ALJ to conclude “there are no relevant witnesses,” but Petitioner does not provide any authority to support this assertion.  RR at 19 (emphasis omitted).  The ALJ did not conclude “there are no relevant witnesses” but rather, after properly denying a subpoena for Petitioner’s unidentified CMS Representative(s) and acknowledging that CMS did not request to cross-examine Petitioner’s sole witness, there was no need for a hearing.  ALJ Decision at 2.  Petitioner refers to its “designated CMS’ representative(s), to be identified through discovery, to testify,” RR at 19, but only rehashes its discovery arguments and fails to show how written direct testimony would come from these hypothetical witnesses that CMS would potentially want to cross-examine.  Importantly, Petitioner does not (and cannot) complain that it was deprived of the right to cross-examine any witness because CMS did not propose any witnesses and did not need to in order to make its case.  See George Yaplee, DAB No. 3003, at 5.  Accordingly, we find no error in the ALJ’s determination that an in-person hearing was unnecessary.

E. Neither an ALJ nor this Board has the authority to consider Petitioner’s constitutional and equitable claims.

Petitioner argues “[t]he ALJ’s approval of CMS’ unauthorized conduct based upon CMS’ own interpretation of the clear and unambiguous Regulations is unconstitutional.”  RR at 20.  Petitioner asserts that by not considering the deactivation decision, “the ALJ Decision work[s] to insulate CMS from any scrutiny and promotes CMS’ unconstitutional expansion of its powers.”  Id. at 8-9.  Petitioner also argues that “only Congress can rewrite [a] statute,” and “[c]ontrary to the ALJ Decision, CMS is not authorized to rewrite or add to its governing and authorizing regulations,” which Petitioner asserts CMS did by deactivating its billing privileges without any basis.  Id. at

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19 (first alteration in original) (emphasis omitted) (citing La. Pub. Serv. Comm'n v. FCC, 476 U.S. 355, 357 (1986)).

Petitioner’s constitutional argument is unavailing.  The Board has long held that ALJs and the Board are bound by the regulations and may not declare them unconstitutional or decline to follow them on that basis.  See, e.g., 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) (internal quotation marks and citations omitted)); 1866ICPayday.com, L.L.C., DAB No. 2289, at 14 (2009) (“An ALJ is bound by applicable laws and regulations and may not invalidate either a law or regulation on any ground, even a constitutional one.”); Fady Fayad, M.D., DAB No. 2266, at 14 (2009) (stating that ALJs and the Board are bound by the regulations and may not declare them unconstitutional or decline to follow them on that basis), aff’d, Fayad v. Sebelius, 803 F. Supp. 2d 699 (E.D. Mich. 2011); Fla. Health Scis. Ctr., Inc., DAB No. 2263, at 6 (2009) (“[I]t is well established that administrative forums, such as this Board and the Department’s ALJs, do not have the authority to ignore unambiguous statutes or regulations on the basis that they are unconstitutional.” (internal quotation marks and citations omitted)).

In Urology Group, the Board addressed a supplier’s attempt to challenge CMS’s deactivation determination on constitutional grounds.  Urology Group, DAB No. 2860, at 14-16.  The Board recognized it could not declare statutes or regulations unconstitutional and decline to follow them.  Id. at 14.  The Board found that the loss of billing privileges during deactivation resulted from the plain language of the regulations that bound the Board.  Id.  The Board explained that the supplier should have been aware of the application of the regulations when applying to participate in Medicare.  Id. at 14-15.  The Board stated that the supplier was not challenging loss of participation in Medicare but, rather, inability to receive reimbursement for services the supplier “chose to provide” to Medicare-eligible beneficiaries during the gap period after the supplier had been advised its billing privileges were deactivated.  Id. at 15.

Here, Petitioner essentially argues that the administrative appeal process created by Part 498 is constitutionally inadequate because it does not allow Petitioner to challenge the deactivation.  See RR at 19 (“The ALJ Erred by Encouraging CMS’ Exercise of the Unconstitutional Authority to Rewrite the Governing Regulations.” (emphasis omitted)).  As discussed above, the regulations provide for no right to ALJ or Board review of a deactivation determination.  We cannot consider Petitioner’s argument because it seeks to overturn the deactivation on constitutional grounds, which we cannot do for the reasons already noted.  See, e.g., 1866ICPayday.com, DAB No. 2289 at 14; Urology Group, DAB No. 2860, at 14-16.

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F. The ALJ did not err in refusing to consider Petitioner’s equitable arguments regarding the impact of CMS’ actions.

Petitioner’s equitable arguments include that “[t]he ALJ erred by refusing to consider the fundamental unfairness and inequity of CMS’ actions and subsequent determination,” RR at 2, and that the ALJ Decision “sends a message to all providers in such circumstances to immediately cease all services to Medicare patients, leaving them unserved and at risk,” RR at 21.   

The ALJ correctly concluded that Petitioner could not be granted relief “based on any equitable or policy arguments.”  ALJ Decision at 5 (citing Sokoloff, DAB No. 2972, at 9).  “The applicable regulations . . . do not provide for consideration of such equitable arguments in ALJ or Board appeals of CMS enrollment determinations.”  Amber Mullins, N.P., DAB No. 2729, at 5 (2016).  “Neither the ALJ nor the Board is authorized to provide equitable relief by reimbursing or enrolling a supplier who,” like Petitioner in this case during its deactivation period, “does not meet statutory or regulatory requirements.”  US Ultrasound, DAB No. 2302, at 8 (2010).  “[T]he Board has repeatedly held that it, and ALJs, are bound by the applicable regulations and cannot alter an effective date based on principles of equity.”  Tosan Fregene, M.D. and Oncology Clinics, Inc., DAB No. 3018, at 6 (2020).  “[I]nsofar as [the supplier] argues that the reactivation date should be set retroactively to the date that CMS deactivated [the supplier’s] billing privileges because the gap in Medicare reimbursement for services furnished to Medicare-covered patients during the deactivation period is unfair, the Board has no authority to provide any equitable relief.”  Sokoloff, DAB No. 2972, at 9 (citing Mullins, DAB No. 2729, at 6).

For these reasons, we reject Petitioner’s equitable arguments and uphold the ALJ’s decision declining to grant Petitioner an earlier effective date based on equitable grounds. ALJ Decision at 5 (citing Sokoloff, DAB No. 2972, at 9).

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Conclusion

We affirm the ALJ’s decision upholding April 3, 2018, as the effective date for reactivation of Petitioner’s billing privileges.

Endnotes

¹  The Act distinguishes between a “provider of services,” which includes hospitals and other types of facilities, and “suppliers,” which the Act defines broadly as “a physician or other practitioner, a facility, or other entity (other than a provider of services) that furnishes items or services” under the Medicare program.  See Act § 1861(d), (u).  This case involves the incorporated organization McIlroy Inc., and we will refer to the organization as a supplier.

²  We cite to and apply the regulations in effect on May 16, 2018, the date CMS’s contractor issued the initial determination regarding the effective date of Petitioner’s reactivated billing privileges.  See Gregory J. Frazer, Au.D., Ph.D., DAB No. 3038, at 1 n.1 (2021); George Yaplee Med. Ctr., DAB No. 3003, at 3 n.3 (2020). 

³  The NPI is the standard unique health identifier for all health care providers under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and must be used in all administrative and financial transactions covered by HIPAA.  See 69 Fed. Reg. 3,434, 3,434-36 (Jan. 23, 2004) (publishing final rule that adopted the NPI as the standard identifier for health care providers in the health care system, including the Medicare program, and providing that HIPAA covered entities must use NPIs to identify health care providers in electronic transactions for which the Secretary has adopted the standard); see also CMS, Examining the Difference between a National Provider Identifier (NPI) and a Provider Transaction Access Number (PTAN), MLN Matters Number: SE1216, 2 (Sept. 5, 2014), (last visited June 5, 2024), https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/SE1216.pdf [hereinafter MLN Matters SE1216] (providing that Medicare requires the NPI be used in all HIPAA standard transactions).

⁴  Together, the NPI and PTAN (also referred to as a Medicare ID number) identify the supplier in the Medicare program.  A supplier must have one NPI and will have one, or more, PTAN(s) related to it in the Medicare system representing the supplier’s enrollment.  See MLN Matters SE1216, supra note 2, at 2-3.

⁵  A 90-day retrospective billing period is authorized in the event of certain Presidentially declared disasters, which does not apply to this appeal.  See 42 C.F.R. § 424.521(a)(2).

⁶  Formerly known as the National Provider System, the NPPES assigns NPIs, collects unique data elements on health care providers, and maintains a record for each health care provider to whom it assigns an NPI as required under HIPAA.  See 89 Fed. Reg. 15,581, 15,581 (Mar. 4, 2024) (providing that CMS is the administrator of NPPES); see generally NPPES, (last visited June 24, 2024), https://nppes.cms.hhs.gov/#/.

⁷  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.

⁸  The NPI Enumerator is responsible for, among other things, managing the NPPES, assisting health care providers in applying for their NPIs, updating their information in the NPPES, and “[p]rocessing NPI applications/updates/deactivations.”  See CMS, Clarification on the National Provider Identifier (NPI) Enumerator’s Responsibilities, MLN Matters Number: SE0751, at 1, (Dec. 10, 2007), (last visited July 1, 2024),  https://www.cms.gov/medicare/medicare-contracting/contractorlearningresources/downloads/ja0751.pdf.

⁹  On the CMS-855I Application, Dr. Arquisola listed the NPI of McIlroy Inc. along with her own practitioner NPI and PTAN but listed the PTAN/Medical ID number for McIlroy Inc. as “pending.”  CMS Ex. 3, at 9, 31, 33, 35, 37; see CMS Ex. 1, at 2; CMS. Ex. 2, at 1.

¹⁰  Novitas allowed a period of retrospective billing beginning 30 days before the effective date of Petitioner’s billing privileges.  Because Petitioner’s billing privileges were deactivated effective January 5, 2018, and reactivated effective April 3, 2018 (with retrospective billing beginning March 4, 2018, 30 days prior to receiving the application on April 3, 2018), a gap exists from January 5, 2018 through March 3, 2018, during which Petitioner did not have Medicare billing privileges.

¹¹  CMS proffered CMS Ex. 4, Novitas’s May 16, 2018 reactivation letter, but the exhibit is incomplete, missing pages 2–8 of the letter.  Petitioner filed its request for hearing (RFH) and supporting attachments as a single 62‑page PDF, in which pages 47–54 of the PDF contain Novitas’s complete May 16, 2018 letter, so we cite the RFH when referring to the reactivation letter to fully explain the procedural background of this case.

¹²  Petitioner refers to the Medicare Program Integrity Manual (MPIM), based on CMS’s reference to the MPIM, CMS Pub. 100-08, Ch. 10, § 4.20 (Rev. 291, Effective Jan. 1, 2008), in their Pre-Hearing Br./ Request for Summary Judgment (CMS ALJ Brief, at 7). 

¹³  With its request for review, Petitioner also filed various forms and documents that are used in proceedings before the Medicare Appeals Council that do not pertain to proceedings before the Board, to include copies of the exhibits filed with the ALJ.  Thus, when citing Petitioner’s request for review, we are referring to Petitioner’s “Addendum A” only.

¹⁴  As the Board noted in Decatur Health, the deactivation regulations in 42 C.F.R. § 424.540 also apply to IDTFs, and the regulation for determining the effective date of billing privileges in “section 424.520(d) is substantively identical to, and was intended to be consistent with, section 410.33(i),” which is the regulation that applies to IDTFs.  See Decatur Health, DAB No. 2805, at 2, 6 n.4.  Thus, we find the analysis in Decatur Health applicable to this case.

¹⁵  The Medicare claim reimbursement process for items and services provided under Medicare Parts A and B begins with a single claim submitted to the contractor, followed by an initial determination from the contractor as to whether the item or service is covered by Medicare.  42 C.F.R. § 405.920.  Here, even if this was the correct forum (which it is not), Petitioner has not provided any evidence of any claim submitted to Medicare. 

¹⁶  Novitas approved retrospective billing as of March 4, 2018, in accordance with 42 C.F.R. § 424.521(a) – 30 days prior to the date the approved enrollment application was received.  Accordingly, there is no issue before the Board as to the approved retrospective billing date.