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                              Heidi Woody, NP, formerly known as Heidi Richards, NP, DAB No. 3102 (2023)
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Heidi Woody, NP, formerly known as Heidi Richards, NP, DAB No. 3102 (2023)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Appellate Division





Heidi Woody, NP, formerly known as Heidi Richards, NP
Docket No. A-22-40Decision No. 3102July 26, 2023

        
              
    

      FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Heidi Woody, NP (Petitioner) appeals the December 21, 2021 decision of an Administrative Law Judge (ALJ) in *Heidi Woody, NP, formerly known as Heidi Richards, NP*, DAB CR6006 (2021) (ALJ Decision).1  The ALJ upheld the determination of the Centers for Medicare & Medicaid Services (CMS) to revoke Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10).  The ALJ concluded that CMS had a legal basis for the revocation on the ground that Petitioner, a nurse practitioner, failed to maintain and provide CMS access to documentation related to referrals Petitioner had made for items of durable medical equipment, prosthetics, orthotics, and/or supplies (DMEPOS) for Medicare beneficiaries.  The ALJ also concluded that the 10-year re-enrollment bar imposed by CMS was not subject to review.

We affirm the ALJ’s decision to sustain the revocation of Petitioner’s enrollment and billing privileges because it is supported by substantial evidence and free of legal error.  We also affirm the ALJ’s conclusion that the length of a re-enrollment bar is not an appealable agency determination.

Legal Background

The Social Security Act (Act) authorizes CMS to administer the Medicare program, in part through contracts with private contractors who perform certain program functions on CMS’s behalf, including the enrollment of providers and suppliers.  Act §§ 1816, 1842, 1874A; 42 C.F.R. §§ 421.5(b), 421.404(c).  A “supplier” of Medicare services – a term that includes non-physician practitioners – must be enrolled in Medicare and maintain active enrollment status to receive payment for items and services covered by Medicare.  42 C.F.R. §§ 400.202 (defining “*Supplier*”), 424.505.2  “Enrollment” is the process CMS

**Page 2**

uses to:  (1) identify a prospective supplier; (2) validate the supplier’s eligibility to provide items or services to Medicare beneficiaries; (3) identify and confirm a supplier’s owner(s) and practice location(s); and (4) grant the supplier Medicare billing privileges.  *Id.* § 424.502 (defining “*Enroll/Enrollment*”); *see also id.* §§ 424.505, 424.510.

Section 424.535(a) permits CMS to revoke a supplier’s Medicare enrollment and billing privileges, and any corresponding supplier agreement, for any of the reasons enumerated in section 424.535(a).  Section 424.535(a)(10), applicable here, provides:

(10)  *Failure to document or provide CMS access to documentation.*(i)   The provider or supplier did not comply with the documentation or CMS access requirements specified in § 424.516(f) of this subpart.(ii)  A provider or supplier that meets the revocation criteria specified in paragraph (a)(10)(i) of this section, is subject to revocation for a period of not more than 1 year for each act of noncompliance.

*Id*. § 424.535(a)(10)(i)-(ii).  Section 424.516, in turn, provides requirements for enrolling in and maintaining active enrollment status in Medicare.  The “documentation” and “access” requirements from section 424.535(a)(10) are explained in section 424.516(f)(2), which sets forth two requirements for physicians and certain other professionals, as follows:

(f)  *Maintaining and providing access to documentation.*

*    *    *    *

(2)(i)   A physician or, when permitted, an eligible professional[3] who orders, certifies, refers, or prescribes Part A or B services, items or drugs is required to —(A)  ***Maintain documentation*** (as described in paragraph (f)(2)(ii) of this section) for 7 years from the date of the service; and(B)   Upon request of CMS or a Medicare contractor, to ***provide access to that documentation*** (as described in paragraph (f)(2)(ii) of this section).

*Id*. § 424.516(f)(2)(i) (bolded italics added).

**Page 3**

The above-referenced “documentation” includes:

written and electronic documents (including the NPI[4] of the physician or, when permitted, other eligible professional who ordered, certified, referred, or prescribed the Part A or B service, item, or drug) relating to written orders, certifications, referrals, prescriptions, or requests for payments for Part A or B services, items, or drugs.

*Id.* § 424.516(f)(2)(ii).

This basis for revocation under section 424.535(a)(10) was implemented under the authority of a provision of the Act, as amended by the Patient Protection and Affordable Care Act, P.L. 111-148, which had authorized revocation of Medicare billing privileges if a supplier failed to comply with the dual requirements to “maintain” and “provide access to” documentation:

The Secretary may revoke enrollment, for a period of not more than one year for each act, for a physician or supplier . . . if such physician or supplier fails to maintain and, upon request of the Secretary, provide access to documentation relating to written orders or requests for payment for durable medical equipment, . . . as specified by the Secretary.

Act § 1842(h)(9).

Revocation of Medicare billing privileges terminates any existing provider enrollment agreement and bars a provider or supplier from participating in Medicare from the effective date of the revocation until the end of the re-enrollment bar.  42 C.F.R. § 424.535(b), (c)(1).  With exceptions not applicable here, the re-enrollment bar “lasts a minimum of 1 year, but not greater than 10 years . . . , depending on the severity of the basis for revocation.”  *Id.*§ 424.535(c)(1)(i).5  Revocation of a supplier’s Medicare billing privileges is one of a limited number of enumerated “initial determinations” from which the supplier may request a “reconsidered determination” from CMS or its contractor.  *Id.* §§ 498.3(b)(17), 424.545(a), 498.5(l)(1), 498.22(a).  A reconsidered

**Page 4**

determination “affirm[s] or modif[ies] the initial determination and the findings on which it was based.”  *Id.* § 498.24(c).  A supplier “dissatisfied with a reconsidered determination . . . is entitled to a hearing before an ALJ.”  *Id.*§ 498.5(l)(2).  A party dissatisfied with an ALJ’s decision may then seek Departmental Appeals Board (Board) review.  *Id.*§ 498.80.

Case Background6

Petitioner was a nurse practitioner who was enrolled in Medicare as a supplier.  ALJ Decision at 1; CMS Ex. 1, at 1.  Petitioner’s “PECOS”7 Enrollment Record Summary listed Covenant Medical Center (Covenant), 1447 N. Harrison Street, Saginaw, Michigan, as her sole “Correspondence Address” starting in August 2017.  CMS Ex. 1, at 2-3.  That address was also listed as Petitioner’s “secondary practice location.”  *Id*. at 5.  Petitioner began working for Covenant in 2007, and reassigned billing privileges to Covenant in August 2017.  Affidavit of Heidi Woody (CMS Ex. 7) at 4 (¶ 3); CMS Ex. 1, at 5.  Petitioner also began employment with St. Mary’s Hospital of Michigan (referenced elsewhere in the record as Ascension St. Mary’s Hospital) in 2007.  CMS Ex. 1, at 5.  Petitioner reassigned billing privileges to St. Mary’s in May 2014, and stopped employment there at some point in 2017.  *See id.*; CMS Ex. 7, at 4 (¶ 4).  For a period of months starting in 2017, and after leaving St. Mary’s, Petitioner worked for a telemedicine company called Advantage Choice Care, LLC (ACC).  ALJ Decision at 2 (citing Req. for Reconsideration (CMS Ex. 7) at 2).  Petitioner “had an agreement with [ACC] . . . to treat patients through their telemedicine platform and the resulting records were maintained as electronic health records in that same platform.”  *Id*. at 4.

By letter dated January 24, 2020, CoventBridge Group (CoventBridge), a CMS unified program integrity contractor (UPIC),8 sent to Petitioner a “formal request for medical documentation” related to 47 DMEPOS referrals for 20 Medicare beneficiaries.  CMS Ex. 2, at 1.  CoventBridge stated that Petitioner’s name and NPI had been listed on DMEPOS suppliers’ Medicare claims as those of the “referring physician.”  *Id.*  Attached was a “Beneficiary List” that identified the 20 beneficiaries, the corresponding codes for the DMEPOS items, and for each listed beneficiary a range of dates of service from 1/1/2016 to 5/21/2019.  *Id.* at 5.  CoventBridge also provided a list of categories of

**Page 5**

documentation that “supports services billed for the following beneficiaries and timeframes,” including:  physician orders and/or prescriptions for services, supplies, and equipment; records providing beneficiaries’ full contact information; and “any and all documentation to support services billed.”  *Id*. at 1-2.  CoventBridge quoted sections 424.535(a)(10) and 424.516(f), and stated that if Petitioner failed to submit the requested records her Medicare billing privileges may be revoked.  *Id*. at 2-3.  CoventBridge sent the letter to Petitioner’s “Correspondence Address” (Covenant) by certified mail, and received a signed delivery receipt on January 29, 2020.  *Id.* at 1; *see also*CMS Ex. 3.

By letter dated July 15, 2020, CoventBridge issued a second notice to Petitioner, stating that it had not received a response to its initial notice and reiterating that if the requested medical records were not received within 15 days, “administrative action, including revocation, may be taken.”  CMS Ex. 4, at 1.  CoventBridge received a signed delivery receipt of the second notice on July 24, 2020.  CMS Ex. 5.  As before, CoventBridge did not receive a response to the second notice.

By letter dated August 18, 2020, Wisconsin Physicians Service (WPS), an administrative contractor acting on CMS’s behalf, sent to Petitioner an initial determination advising that it had revoked Petitioner’s Medicare enrollment and billing privileges, effective September 17, 2020.  CMS Ex. 6, at 1.  WPS stated that the basis of the revocation was section 424.535(a)(10), due to Petitioner’s failure to comply with 42 C.F.R. § 424.516(f).  *Id*.9  WPS informed Petitioner that it had imposed a 10-year bar to re-enrollment in the Medicare program, pursuant to section 424.535(c).  *Id.*at 2.

On May 19, 2021, Petitioner submitted a letter to WPS titled “Heidi Richards Revocation Appeal,” which CMS construed as a request for reconsideration.  CMS Ex. 7, at 1-3; CMS Exs. 8, 10.  Petitioner requested re-enrollment in Medicare and asserted that “good cause has been shown to support waiver of the timely appeal filing requirement.”  CMS Ex. 7, at 3.  In the letter and an attached affidavit, Petitioner stated that she had not received the revocation notice or the two record requests, and first learned of them in April 2021. *Id*. at 1, 4­-6.  Petitioner said she was not at fault for the “alleged ‘failure to respond,’” which “was clearly out of my control” as the notices had not been “served upon on me personally” or “at my home address.”  *Id*. at 3, 6.  Regarding documentation, Petitioner stated in the letter that she worked “for a short time in 2017 for a telemedicine company, [ACC,]” and that while she did “not know concretely at present,” it was “possible” that the 20 identified beneficiaries were patients of ACC.  *Id.* at 2-3.  Petitioner stated that she did “not believe Covenant has any affiliation with [ACC] and the charts I reviewed for [ACC] were independent of my work with Covenant.”  *Id*. at 2.

**Page 6**

In emails to Petitioner dated June 7-8, 2021, CMS acknowledged receipt of Petitioner’s request for reconsideration, provided copies of the revocation notice and medical records requests, and offered Petitioner another opportunity to submit the requested records, by no later than June 22, 2021.  CMS Ex. 8.  CMS provided a hyperlink for Petitioner to use to upload the records.  *Id*. at 1.  In an email response dated June 9, 2021, Petitioner’s then-counsel conceded:  “The short answer to your request for records is that [Petitioner] has no records for these patients.  She was working remotely for a telemedical company, who maintained the records for the treatments.”  *Id*.  Petitioner’s counsel also submitted a letter and “Acknowledgment of Completion” from Covenant’s Professional Billing Manager, who stated that an internal search confirmed that Covenant possessed no records related to the 20 beneficiaries.  CMS Ex. 9, at 1, 5.

By letter dated June 23, 2021, CMS issued a reconsidered determination.  CMS Ex. 10.  CMS found that Petitioner’s request for reconsideration was untimely, yet, without explanation, granted a “good cause waiver.”  *Id.* at 1.10  CMS upheld the revocation determination pursuant to section 424.535(a)(10), explaining that because Petitioner is an “eligible professional” who “provided Medicare Part B services, including ordering and certifying DMEPOS,” the document maintenance and access requirements from section 424.516(f)(2) applied to Petitioner personally.  *Id.* at 3.CMS stated that Petitioner admitted to not possessing the requested records, and thus failed to “maintain” the records under section 424.516(f)(2)(i)(A).  *Id.* at 4.  CMS added that despite being sent two notices at the address provided on her PECOS enrollment record, and then being sent an upload link months after the date of the revocation notice, Petitioner still did not produce the records, thus failing to “provide access” to them under section 424.516(f)(2)(i)(B).  *Id.*CMS clarified that whether or not Covenant had the requested records “has no bearing on [Petitioner’s] responsibility to maintain documentation for the Medicare beneficiaries she treats . . . and provide the records upon request.”  *Id*.

CMS also upheld the 10-year bar to Medicare re-enrollment that WPS had imposed, explaining that Petitioner “failed to provide access to medical documentation pertaining to 20 beneficiaries,” and therefore “[e]ach failure constitutes an individual act of noncompliance for each beneficiary.”  CMS Ex. 10, at 4.11

**Page 7**

The ALJ Decision

Petitioner then sought ALJ review, and on December 21, 2021, the ALJ issued a decision based on the written record.  ALJ Decision at 4.  The ALJ sustained the revocation of Petitioner’s billing privileges pursuant to 42 C.F.R. § 424.535(a)(10), for failure to comply with section 424.516(f)(2).  *Id.*at 6.  The ALJ explained that both the UPIC and CMS had “requested that Petitioner provide copies of medical records for 20 Medicare beneficiaries for whom she had ordered DMEPOS items[,]” and noted that Petitioner conceded to not maintaining the requested records and also failed to produce them for the UPIC despite being given many opportunities to do so.  *Id*.  Therefore, as it was undisputed that Petitioner failed to “maintain” or “provide access to” the requested records, the ALJ concluded that “CMS had a legitimate basis to revoke her Medicare enrollment and billing privileges” under section 424.535(a)(10).  *Id*.

Petitioner argued she should be excused from these obligations because her agreement with ACC required that patient records be maintained on ACC’s digital platform, and because Petitioner no longer had access to that platform as she had “not been affiliated with [ACC] for a number of years[.]”  P. Br. at 4, 9.  Petitioner added that while attempting to contact ACC, she “learned for the first time that the owners of [ACC] had been indicted and that the company was no longer operating, and its records had been seized.”  P. Br. at 4; *see also* CMS Ex. 11 (January 31, 2020 indictment in *USA v. Wilson, et al.*, Civ. No. 2:20-CR-00111-KM (D.N.J. 2020), charging ACC’s owners with conspiring to commit health care and wire fraud against the United States, conspiring to commit money laundering, and soliciting and receiving kickbacks).  The ALJ was not persuaded, stating:  “Regardless of whether another entity purports to maintain copies of beneficiary records, Petitioner, as the ordering practitioner and a supplier in the Medicare program, was required, pursuant to [section] 424.516(f), to maintain and retain for at least seven years documentation supporting her DMEPOS orders for Medicare beneficiaries.”  ALJ Decision at 6.

The ALJ added that this individual obligation derived from the regulatory history of sections 424.535(a)(10) and 424.516, stating:

[T]he rulemaking adding the instant basis for revocation and revising [section] 424.516 specifically explained that both a practitioner and another entity may simultaneously be required to maintain, *inter alia*, records supporting DMEPOS orders, stating that “[t]his final rule places the responsibility for the maintenance of records on *both*the ordering and certifying physician and the provider and supplier.”  The rulemaking unambiguously clarified that “[t]he physician or other eligible professional who signed the order or certification is responsible for maintaining and disclosing the documentation.”

**Page 8**

ALJ Decision at 7 (quoting 77 Fed. Reg. 25,284, 25,310 (Apr. 27, 2012)) (emphasis added by ALJ).

Relatedly, the ALJ stated that any private agreement Petitioner may have made with ACC regarding the custody and retention of patient records “cannot exempt her from Medicare participation requirements.”  *Id*. at 7.  The ALJ explained:

Notwithstanding the terms of her agreement with [ACC] to use its electronic records platform, Petitioner, as a Medicare participant, was independently required to maintain and retain, for a period of seven years, documentation supporting her written orders and prescriptions for Part A and B items and services.  Specifically, as relevant here, Petitioner was required to maintain documentation relating to her orders for DMEPOS items.  Petitioner’s failure to maintain, retain, and provide access to records supporting the DMEPOS orders that were requested by the UPIC subjects her to revocation of her enrollment pursuant to 42 C.F.R. §§ 424.535(a)(10) and 424.516(f).

*Id.* at 6-7 (citing 42 C.F.R. § 424.516(f)(2)) (footnote omitted).

In response to Petitioner’s claim that efforts to obtain the requested patient records from ACC were prevented by the ongoing criminal action against ACC’s owners, the ALJ noted that the basis for revocation set forth in section 424.535(a)(10) and the documentation and access requirements set forth in section 424.516(f)(2) “both originate from anti-fraud provisions of the Patient Protection and Affordable Care Act, P.L. 111-148,” [as amended],” and emphasized that Petitioner’s inability to obtain the allegedly seized records after her employment relationship with ACC had ended “demonstrate[s] the value of requiring practitioners to maintain and retain their own documentation of DMEPOS orders to Medicare beneficiaries.”  ALJ Decision at 7 n.4 (citing 77 Fed. Reg. at 25,309-25,312).

The ALJ also dismissed Petitioner’s argument that the revocation was “an unnecessary sanction” that would harm the community Petitioner served, as this amounted to an impermissible challenge to CMS’s exercise of discretion to revoke Medicare enrollment.  ALJ Decision at 8 (“The [Board] has explained that ‘it is not for the ALJ and the [Board] to look behind that exercise of discretion to ask whether he or she, or the Board, standing in CMS’s shoes, would reach the same decision to revoke.’” (quoting *George M. Young, M.D.*, DAB No. 2750, at 11 (2016)).

Lastly, the ALJ rejected Petitioner’s challenge to the length (10 years) of the re-enrollment bar, noting that the Board has “unambiguously” held that challenges to the length of a re-enrollment bar are “beyond the scope of an ALJ’s review,” and quoting the following from a 2019 Board decision:

**Page 9**

A decision by CMS or its contractor about how long to bar a revoked supplier from re-enrolling in Medicare, unlike the determination to revoke the supplier’s billing privileges, is not an appealable “initial determination” under 42 C.F.R. Part 498.  *Blossomwood Medical, P.C., et al.*, DAB No. 2914, at 11 (2018); *Vijendra Dave, M.D.*[DAB No. 2672,] at 8-11 [(2016)] (stating that the authority of an ALJ or the Board in a revocation appeal “does not extend to reviewing the length of the re-enrollment bar imposed by CMS”).  We therefore cannot consider or act upon Petitioner’s contention that the three-year re-enrollment bar was excessive in her circumstances.

ALJ Decision at 8 (quoting *Linda Silva, P.A.*, DAB No. 2966, at 11 (2019)).

Nevertheless, the ALJ went on to examine section 424.535(a)(10), the legal basis for Petitioner’s revocation, to determine whether there was any “legal error” in the re-enrollment bar CMS imposed.  The ALJ stated that section 424.535(a)(10)(ii) provides that a supplier “is ‘subject to revocation for a period of not more than 1 year for each act of noncompliance,’” and that, in accordance with section 424.535(c)(1)(i), “CMS may impose a re-enrollment bar for a minimum of one year and a maximum of ten [y]ears.”  ALJ Decision at 8.  The ALJ concluded that because Petitioner had failed to provide CMS with records related to 20 Medicare beneficiaries, Petitioner “was noncompliant with 20 requests for records” and “CMS was therefore authorized to impose a re-enrollment bar of up to one year per violation, capped at a maximum of 10 years.”  *Id.* at 9 (citing 42 C.F.R. § 424.535(a)(10)(ii), (c)(1)(i)).  The ALJ stated that Petitioner had “not identified any legal error in CMS’s imposition of the re-enrollment bar[,]” then concluded by reiterating that an ALJ “may not otherwise review the duration of the re-enrollment bar.”  *Id.* (citing *Vijendra Dave, M.D.* at 11 (“CMS’s determination regarding the duration of the re-enrollment bar is not reviewable.”)).

Standard of Review

The standard of review on a disputed factual issue is whether the ALJ’s decision is supported by substantial evidence in the record as a whole.  The standard of review on a disputed issue of law is whether the ALJ’s 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*”), available at https://www.hhs.gov/about/agencies/dab/different-appeals-at-dab/appeals-to-board/guidelines/enrollment/index.html?language=en.

**Page 10**

Analysis

On review of a determination to revoke a supplier’s Medicare billing privileges, an ALJ and the Board “decide only whether CMS has established a lawful basis for the revocation.”  *Cornelius M. Donohue, DPM*, DAB No. 2888, at 4 (2018).  If CMS establishes that basis, the ALJ must uphold it.  *Lilia Gorovits, M.D., P.C.*, DAB No. 2985, at 10 (2020), *aff’d*, *Gorovits v. Becerra*, No. 2:20-cv-01850 (E.D. Pa. May 17, 2021); *accord Stanley Beekman, D.P.M.*, DAB No. 2650, at 10 (2015) (ALJ and the Board must uphold a revocation “[i]f the record establishes that the regulatory elements” are met).  Although the regulation affords CMS discretion to revoke or not revoke in a particular case, the role of the ALJ and the Board “is limited to determining whether CMS’s action is legally authorized and does not extend to second-guessing whether CMS properly exercised its discretion.”  *Acute Care Homenursing Servs., Inc.*, DAB No. 2837, at 9 (2017).

Below, we first affirm the ALJ’s decision to uphold CMS’s revocation of Petitioner’s Medicare billing privileges under section 424.535(a)(10), for failure to comply with the documentation maintenance and access requirements of section 424.516(f)(2), as the decision is supported by substantial evidence and free of legal error.  We next uphold the ALJ’s conclusion that CMS’s determination to impose a 10-year re-enrollment bar is not a determination that an ALJ, under Part 498 regulations, may review.

***The ALJ correctly concluded that CMS lawfully revoked Petitioner’s Medicare billing privileges under 42 C.F.R. § 424.535(a)(10), because Petitioner failed to “maintain” and to “provide access” to the requested documentation.***The plain language of section 424.516(f)(2) requires physicians and other eligible professionals, such as nurse practitioners, who order or provide referrals for the supply of DMEPOS billed to Medicare to do two things.  First, they must “maintain,” for a period of seven years, certain documentation (written or electronic) related to written orders, certifications, or requests for payments for DMEPOS.  Second, they must provide CMS or its contractor “access” to that documentation “upon request.”  42 C.F.R. § 424.516(f)(2)(i)(A)-(B).  Failure to satisfy either requirement provides a valid basis for revocation of billing privileges.  *Id*. § 424.535(a)(10).

Petitioner does not dispute the ALJ’s finding that the documents the CMS contractor requested were generated while Petitioner was under contract with ACC.  Petitioner also does not dispute the finding that the 20 Medicare beneficiaries whose names appear on the contractor’s records requests were ACC patients for whom Petitioner, as an “eligible professional” under section 424.516(f)(2), provided referrals for the supply of DMEPOS.  The regulation’s language therefore plainly required Petitioner to personally maintain copies of documentation related to written orders or referrals for DMEPOS for those

**Page 11**

beneficiaries, for a period of seven years, and also to produce them (or otherwise to “provide access”) for the contractor when it requested them.

Petitioner continually has conceded she did not maintain the requested documentation, stating to CMS in an email exchange after receiving the revocation determination that Petitioner “*has no records for these patients*.  She was working remotely for a telemedical company, who maintained*the records* for *the treatments*.”  CMS Ex. 8, at 1 (emphasis added); *see also*P. Br. at 4 (stating to ALJ that, “[a]s is common for mid-level providers, her patient records were maintained by the [ACC] practice”).  Before the Board, Petitioner again admits to not maintaining her own documentation, stating that as a condition of her contract with ACC, those “records were maintained as electronic health records in [the telemedicine] platform[;]” that ACC “was the custodian of the records at issue[;]” and that after learning of the CMS records requests, Petitioner “attempted to contact [ACC] to produce the requested records that were in their custody.”  RR at 4-5.

Petitioner also does not dispute the ALJ’s finding that she did not provide CMS access to the requested records when the requests were made.  *See*42 C.F.R. § 424.516(f)(2)(i)(B) (requiring the physician or practitioner to “provide access” to the requested documentation “[u]pon request of CMS or a Medicare contractor”).  The facts in the record establish that Petitioner failed to produce the records, or otherwise make them available for examination, in response to the requests sent to the address listed on Petitioner’s current PECOS enrollment record – and again failed to produce the records when, 10 months after the initial revocation determination, CMS gave Petitioner another two weeks to produce the requested documents and provided an upload hyperlink for Petitioner’s convenience.  *See*ALJ Decision at 3 (citing CMS Ex. 10).  Thus, based on these undisputed facts, the ALJ did not err in concluding that “Petitioner’s failure to maintain, retain, and provide access to records supporting the DMEPOS orders that were requested by the UPIC subjects her to revocation of her enrollment pursuant to [sections] 424.535(a)(10) and 424.516(f).”  *Id.* at 7 (citation omitted).

Faced with these facts, Petitioner mischaracterizes the ALJ’s decision, asserting that it was based on an “incorrect finding” that the records at issue are not “accessible” and “available for review.”  RR at 2, 20.  Petitioner again states that her contract with ACC required patient records to stay in ACC’s custody, but that normally in such arrangements “providers and patients also have a right to the information and are able to access the records on request as necessary.”  *Id.* at 7; *see also id*. at 4 (“[A]lthough the records stay with the custodian-employer, providers are nevertheless always able to access them upon request.”).  Building from this refashioned concept of “accessibility,” Petitioner appears to argue she complied with section 424.516(f)(2) because she used to have *access* to records on ACC’s digital platform, asserting that “there are overlapping claims on who controls medical information and who is to have custodianship[,]” and “[j]ust because a provider does not keep a physical copy of the records or own the computer it is stored in does not mean that they have failed this condition of participation.”  *Id*. at 7.  Petitioner

**Page 12**

also reiterates her claim that the records CMS requested are among the ACC records seized by the FBI, and that federal prosecutors have refused to release them.  *Id.* at 5-6.  Petitioner states that Covenant’s failure to timely forward to her the records requests or revocation notice was relevant, and speculates that had she been notified of the first records request when it was received, she could have obtained access to the records from ACC, because, “upon information and belief,” the first request “predates the subsequent seizure of these records by the United States Government.”  *Id*. at 3.  Petitioner argues that, given this prior “access” to ACC’s records, it is “unfair” to revoke her billing privileges “for allegedly failing to provide such access when another department of the Government has seized such records” and prevented her from obtaining them.  *Id*. at 7.  Petitioner also argues that if she were able to obtain these records now, she could still satisfy the requirements of section 424.516(f)(2).  *Id*. at 7-8.

Despite Petitioner’s contentions, the ALJ made no finding about the current location of the requested records, or about whether they are currently “accessible” or “available for review.”  Those questions were irrelevant to the ALJ’s findings that:  CMS requested certain documentation from Petitioner; Petitioner did not, upon request, “produce the requested documentation because she *did not maintain* *her own copies of these records*;” and, therefore, CMS had a lawful basis to revoke Petitioner’s billing privileges pursuant to section 424.535(a)(10).  ALJ Decision at 6 (emphasis added).  The ALJ correctly found that regardless of ACC’s record retention practices or any agreements between ACC and Petitioner, under the plain meaning of the regulation Petitioner “was required to independently maintain documentation of her orders for, *inter alia*, DMEPOS items for Medicare beneficiaries.”  *Id*. at 6-7 (quoting 42 C.F.R. § 424.516(f)(2)).  Whether or not Petitioner previously was able to access *ACC’s* patient records has no bearing on the correctness of the ALJ’s conclusion.

The ALJ’s decision is also supported by the preamble to the rulemaking that revised the revocation basis under section 424.535(a)(10) and added section 424.516(f)(2).  *See* 77 Fed. Reg. at 25,310.  In response to a comment stating “that a referral to home health care or for DMEPOS at a hospital or nursing home discharge would typically be retained in that hospital’s or nursing home’s records, not by the physician in his/her records[,]” CMS stated:  “The physician or other eligible professional who signed the order or certification is responsible for maintaining and disclosing the documentation.”  *Id.*To remove any ambiguity, CMS then clarified:  “This final rule places the responsibility for the maintenance of records on *both*the ordering and certifying physician *and* the provider and supplier.”  *Id.* (emphasis added).  It is therefore clear from both the regulation’s language and its history that CMS imposed *individual*requirements on professionals like Petitioner to maintain and disclose their own “documentation.”

In *George M. Young, M.D.*, DAB No. 2750 (2016), the Board rejected arguments similar to those Petitioner makes here, holding that under section 424.516(f)(2), an ordering physician or other eligible professional “maintains” the required “documentation” only

**Page 13**

by keeping and retaining their own records, and may not be excused from this obligation because their employer or any other entity customarily maintained those records.  *Id.*at 8-11.  Dr. Young was briefly a physician who examined patients referred to his employer, Sleep Medical Center (SMC), to assess for symptoms of sleep apnea.  *Id.* at 3.  Dr. Young also signed prescriptions for DMEPOS items for patients if SMC, based on sleep studies, made that recommendation.  *Id.* When CMS later requested DMEPOS documentation from Dr. Young pursuant to section 424.516(f), he admitted he did not possess the records and could not locate them, as SMC had gone out of business and its owner (“H.Z.”) had disappeared and “absconded with the records.”  *Id*. at 5.

The ALJ affirmed CMS’s revocation of Dr. Young’s billing privileges, and the Board upheld the ALJ’s decision.  *Id.* at 1.  The Board rejected Dr. Young’s argument that he should be excused from personally maintaining the requested patient records, “because he himself was not in a position to maintain the documents personally or exercise direct control over them since he was not an owner of SMC but merely was a staff physician employed by SMC.”  *Id.* at 9.  The Board quoted the preamble language noted above, from which it concluded that the regulation’s language and its history required individual physicians such as Dr. Young to maintain and disclose their own DMEPOS-related records, regardless of whether it was their custom to do so:  “CMS contemplated that even physicians who may not have immediate, ready access to and direct control over medical documents (as, for example, a doctor who owns his or her own practice and keeps the medical documents within his or her medical office might) would be expected to adhere to the record retention and disclosure requirements. . . .”  *Id*. at 10.

The Board also rejected Dr. Young’s argument that he should be exempted from the “access” requirement of section 424.516(f)(2)(i)(B) because circumstances “beyond his control” – the owner’s closing of SMC and “absconding” with the records – prevented him from producing the records for CMS.  *Id*. at 10-11.  The Board stated that such alleged facts “do not specifically go to the requirement that the ordering physician, Petitioner, maintain the documents as they are created and retain them for a period of seven years for purposes of providing CMS access to them should CMS or its contractor request to see them sometime during that period.”  *Id*. at 10.  The Board continued:

Regardless of H.Z.’s alleged actions, which Petitioner himself said took place after he left his position at SMC, Petitioner, as ordering physician, was required to maintain the records as they were developed in the course of his examining patients for possible need for DMEPOS items, i.e., during the period he was a physician at SMC . . . .  [M]uch of what Petitioner complains of, H.Z. closing SMC and absconding with the records, concerns the hurdles Petitioner encountered in trying to obtain the records to respond to CMS in 2015; it does not, however, excuse Petitioner’s failure to maintain records from the time they came into existence through a period of seven years as required under the regulation.

**Page 14**

*Id*. at 10-11.  The Board also dismissed as immaterial Dr. Young’s argument that he fulfilled his obligations when, months after the deadline CMS had established, he produced various patient records as an attachment to his request for reconsideration.  *Id*. at 9.  The Board stated that it need not resolve the parties’ dispute about whether the belatedly-produced records “comply with section 424.516(f)(2)(ii) in every way,” because, regardless, Dr. Young had still “failed to maintain the documents as he [wa]s required to do under section 424.516(f)(2).”  *Id*. at 9-10.

Just as in *Young*, we are not persuaded by Petitioner’s attempts to evade the clear requirements of sections 424.535(a)(10) and 424.516(f).  Despite Petitioner’s contention that “[j]ust because a provider does not keep a physical copy of the records or own the computer it is stored in does not mean that they have failed this condition of participation,” that is not the situation presented in this case.  RR at 9.  Section 424.516(f)(2) required Petitioner to *individually* maintain her own “documentation,” not to rely on others to do so.  The regulation does not permit an “eligible professional” such as Petitioner to satisfy this requirement merely by being granted access, either at the time of the request for records or at some time in the past, to the records of an employer or other entity that *did* maintain those records.  The ALJ thus correctly rejected Petitioner’s arguments regarding ACC’s record retention practices, or any related agreements with Petitioner, and correctly concluded that Petitioner failed to personally “maintain” documentation pursuant to section 424.516(f)(2)(i).

Accordingly, we reject as irrelevant Petitioner’s speculative theory that had Covenant forwarded the initial records request when it received it in January 2020, then Petitioner *would have* been able to satisfy the demands in the request because Petitioner *would have had* access to ACC’s telemedicine platform just before the FBI allegedly served a warrant on ACC’s owners and seized its records.  *See* RR at 3.12  Initially, Petitioner is required to ensure that the correspondence address for the practice location in her PECOS enrollment record is current, and to timely report to her “Medicare contractor” any change in practice location that may occur.  *See*42 C.F.R. § 424.516(d).  Thus, Petitioner bears the consequences for failing to receive any notices sent by that contractor to the listed correspondence address, and Petitioner’s allegation that Covenant was in some way at fault for not timely forwarding records requests that were sent to Petitioner at that listed address is not a viable premise on which to build a theory of compliance.

More important, Petitioner’s argument that she still had access to ACC’s patient records immediately prior to the alleged FBI seizure, and thus would have been able to comply with section 424.516(f)(2) in late January 2020, is refuted by her own statements before

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the ALJ and the Board.  Petitioner admitted that her access to the records on ACC’s platform ceased *as soon as she stopped working for ACC in 2018*, almost two years before the first records request was sent.  *See*P. Br. at 4 (asserting that in April 2021, “[b]ecause [Petitioner] had not been affiliated with [ACC] for a number of years, she no longer had access to their platform and the records at issue in their custody”); RR at 5 (“Because [Petitioner] had not been affiliated with [ACC] for a number of years, she no longer had access to their telemedicine platform and electronic health records.”).  Therefore, any “access” to ACC’s patient records that Petitioner may have enjoyed ended long before the date when she believes the FBI seized ACC’s records; and the FBI seizure, if it did happen after Covenant received the January 2020 records request, could not have caused Petitioner to lose this “access” that she believes would have allowed her to fulfill her obligations under section 424.516(f)(2).  Finally, as we have made clear, even if Petitioner still had “access” to ACC’s digital platform when Covenant received the first records request, and even if it is true that at that time the FBI had not yet seized ACC’s records, such facts would not conflict with the ALJ’s determination that Petitioner admitted to not maintaining her own *individual*patient records from the time they were created, as required by regulation.  *See* ALJ Decision at 6-7.  That finding alone serves as a valid basis, under sections 424.516(f)(2) and 424.535(a)(10), for CMS to revoke Petitioner’s Medicare billing privileges.

Similarly irrelevant is the *current*location of the requested patient records, including whether federal agents have them or might release them.  Even if Petitioner, during the proceedings before the ALJ, successfully obtained these records from federal agents or from any other source, that would not have cured her failure to contemporaneously maintain personal copies of the requested records, or to provide CMS access to the records *when they were requested*.  *See Young* at 9-10.  Likewise, to the extent Petitioner argues it is unfair to hold her accountable because the alleged FBI seizure of ACC’s records was beyond her control, the Board’s decision in *Young* forecloses such an argument and makes clear that, regardless of any external “hurdles” a practitioner might face in trying to obtain records from a former employer that had possessed those records, that “does not . . . excuse Petitioner’s failure to maintain records from the time they came into existence through a period of seven years as required under the regulation.”  *Id.*at 11.  Just as it was within Dr. Young’s control to maintain the required documentation as it was created, and to provide access to it when it was requested, it was within Petitioner’s control to do the same.  Far from excusing her failure to comply, Petitioner’s challenges in obtaining patient records years after she stopped working for ACC underscore the importance for practitioners such as Petitioner to maintain their own records as they are made – both to ensure compliance with the regulation and to preempt the need to depend on the record retention practices of other sources after failing to do so.

**Page 16**

***The ALJ correctly refused to remand the appeal to CMS to consider alleged “mitigating circumstances” and “beneficiary access to care.”***We also reject Petitioner’s contention that the ALJ erred by refusing to remand the case to CMS so that it could “properly consider mitigating factors.”  RR at 11.  Petitioner argues that CMS, in deciding whether to issue this revocation determination, was “***required*** to consider mitigating circumstances, program and beneficiary risk if enrollment is to continue, beneficiary access to care, and any other pertinent factors,” but failed to do so.  *Id.* (citing 71 Fed. Reg. 20,754, 20,761 (Apr. 21, 2006)).13  Petitioner accepts the ALJ’s conclusion that an ALJ has no authority “to look behind [the] exercise of discretion to ask whether he or she, or the Board, standing in CMS’s shoes, would reach the same decision to revoke.”  *Id*.  Yet Petitioner contends it was “within the scope of the ALJ’s review to determine if CMS did, in fact, m[e]et their requirement to sufficiently consider” any such circumstances in this case, and asserts that the ALJ “erred in finding that these arguments amount only to a challenge to how CMS exercised its discretion.”  *Id.* at 11-12.  Repeating assertions made before the ALJ, Petitioner provides an exhaustive account of her alleged good works as a nurse practitioner, including for underserved members of the local community who, Petitioner says, will suffer unduly as a result of CMS’s revocation decision.  *Id*. at 11-19.

We agree there was no basis for the ALJ to set aside CMS’s revocation or remand the appeal to CMS based on Petitioner’s claim that CMS failed to consider “mitigating circumstances” or “beneficiary access to care.”  We initially observe that Petitioner did not include this argument or this narrative regarding “mitigating circumstances” and the patients she serves as part of her request for reconsideration, and raised it for the first time before the ALJ.  *Compare*P. Br. *with* CMS Ex. 7.  Therefore, Petitioner can only guess what information CMS knew and considered before deciding to revoke Petitioner’s enrollment.  Further, no law or regulation requires CMS to articulate the factors it weighed, or how it weighed them, before issuing a valid revocation, and, as we explained above, the ALJ’s and Board’s review of a revocation decision is limited to determining only whether CMS had a legal basis for its action, which we have concluded it did.

Despite Petitioner’s attempt to redefine an ALJ’s review of the factors entering into CMS’s revocation decisions as something other than a review of the use of discretion, that is precisely what it is.  While CMS “may have discretion to consider unique or mitigating circumstances in deciding whether, or how, to exercise its revocation authority,” *Care Pro Home Health, Inc.*, DAB No. 2723, at 9 n.8 (2016), ALJs and the Board may not “substitute [their] discretion for that of CMS in determining whether

**Page 17**

revocation is appropriate under all the circumstances.”  *Abdul Razzaque Ahmed, M.D.*, DAB No. 2261, at 19 (2009), *aff’d, Ahmed v. Sebelius*, 710 F. Supp. 2d 167 (D. Mass. 2010).  This principle applies just as equally to contentions that CMS failed to adequately consider a petitioner’s purported good deeds or reputation, or the effect the revocation might have on patient communities.  *See, e.g., Pennsylvania Physicians, P.C.*, DAB No. 2980, at 13 (2019) (“[W]e must sustain a revocation that is lawful under the applicable regulations regardless of other factors, such as the financial impact of the revocation on the supplier, that CMS might reasonably have weighed in exercising its discretion about whether or not to revoke.”) (internal quotation marks omitted); *Dinesh Patel, M.D*., DAB No. 2551, at 10 (2013) (holding that Board had no authority to overturn revocation based on Medicare beneficiaries’ need for revoked physician’s services); *Norpro Orthotics & Prosthetics, Inc.*, DAB No. 2577, at 7 (2014) (sustaining revocation despite supplier’s claim that it would cause business to downsize and release employees).14  Therefore, the ALJ correctly refused to review CMS’s decision to determine whether or how it exercised its discretion to revoke Petitioner’s billing privileges.

***The Board denies Petitioner’s request that the Board remand the appeal to the ALJ with instructions to issue a subpoena to produce documents, or that the Board issue its own subpoena to produce documents.***Petitioner requests that the Board remand the appeal with instructions to the ALJ to issue a subpoena to “the Government” (Petitioner does not specify which part) to produce the patient records CMS had requested.  RR at 8.15  As noted above, Petitioner admits she has failed to maintain or obtain these records, which she believes are among the records allegedly seized by the FBI.  *Id.* at 5-8.  Petitioner appears to believe that obtaining the records at this late stage might result in some relief from the revocation CMS imposed.

We deny Petitioner’s request.  We first note that Petitioner has forfeited the right to seek the issuance of a subpoena from the ALJ, having failed to make the same request to the ALJ when that opportunity was available.  Petitioner correctly notes that 42 C.F.R. § 498.58(a) permits an ALJ, “upon his or her own motion or at the request of a party, [to] issue subpoenas if they are reasonably necessary for the full presentation of a case.”  RR at 8.  However, in the event of a party-requested subpoena, the party must file a written request “with the ALJ at least 5 days before the date set for the hearing.”  42 C.F.R. § 498.58(b).  Before the ALJ, *see*P. Br. at 4-5, Petitioner detailed the attempts to obtain

**Page 18**

the requested patient records from Department of Justice employees, yet Petitioner failed to make any subpoena request to the ALJ, pursuant to section 498.58(a), for the records which she believed existed and would have provided her relief – within the time constraint provided by section 498.58(b) or at any other time before the ALJ issued the decision.  Having failed to make this request for a subpoena at the one time when that option was available, Petitioner may not now raise the issue for the first time before the Board.  The Board *Guidelines*, which were provided to Petitioner with the ALJ Decision, state that 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*.”  *Guidelines*(“Completion Of The Review Process”), ¶ (a) (emphasis added); *accord Complete Home Care, Inc.*, DAB No. 2525, at 5 (2013) (Board “will not consider issues which could have been presented to the ALJ but were not”); *ACT for Health, Inc*., DAB No. 1972, at 5 (2005) (stating that *Guidelines*’ prohibition on raising issues not presented to ALJ “mirrors the rule applied in federal appellate courts, which generally refuse to consider issues or arguments raised for the first time on appeal”).  Before the ALJ, Petitioner possessed the same information that now serves as the basis for her request for a subpoena, yet she failed to file a request for subpoena so that the ALJ could rule upon it.  Petitioner may not now ask the Board to provide a remedy for her failure to act.

Moreover, we need not remand Petitioner’s appeal to the ALJ because the documents produced in response to a subpoena to a federal government agency would be immaterial to the ultimate issue before the ALJ.  *See* 42 C.F.R. § 498.58(a) (permitting an ALJ to “issue subpoenas if they are reasonably necessary for the full presentation of a case”).  As we made clear above, even if federal prosecutors possess completely responsive patient records, as Petitioner contends, and even if Petitioner were now able to obtain those records, those facts would not negate the ALJ’s conclusion that “Petitioner could not produce the requested documentation because she did not maintain her own copies of the records,” as required by section 424.516(f)(2).  ALJ Decision at 6.  A subpoena to federal prosecutors therefore would not be relevant, let alone “reasonably necessary,” for the “full presentation” of Petitioner’s case on appeal in accordance with section 498.58(a).

In a similar vein, we decline Petitioner’s request that the Board itself issue a subpoena to “the Government” requiring the production of documents.  *See*RR at 7-8.  The regulations in 42 C.F.R. Part 498, subpart E, which govern Board review of ALJ decisions, do not expressly give the Board authority to issue subpoenas as section 498.58(a) authorizes ALJs to do.  The Board, moreover, has no authority to review new evidence in appeals such as this one.  By regulation, the Board may decide appeals of ALJ decisions on CMS enrollment determinations (including enrollment revocations) based only on the evidentiary record on which the ALJ decided the case.  *See*42 C.F.R. § 498.86(a) (“*Except for provider or supplier enrollment appeals*, the Board may admit evidence into the record in addition to the evidence introduced at the ALJ hearing (or the documents considered by the ALJ if the hearing was waived) if the Board considers that the additional evidence is relevant and material to an issue before it.”  (emphasis added));

**Page 19**

*see also* *MedStar Health, Inc.*, DAB No. 2684, at 6 (2016) (stating that section 498.86(a) “expressly except[s] provider and supplier enrollment appeals from the general rule authorizing the Board to admit additional evidence that the Board finds is relevant and material”); *Chaplin Liu, M.D.*, DAB No. 2976, at 8 n.4 (2019) (Board refusing newly submitted evidence, as regulations prohibit Board from reviewing new evidence in revocation appeals); *Guidelines*, “Development Of The Record On Appeal,” ¶ (f) (“The Board may not admit evidence into the record in addition to the evidence introduced at the ALJ hearing or in addition to the documents considered by the ALJ if the hearing was waived.”  (citing 42 C.F.R. § 498.86(a)).  Accordingly, Petitioner’s reliance on 42 C.F.R. § 498.86(b) (“If it appears to the Board that additional relevant evidence is available, the Board will require that it be produced.”), *see* RR at 8 and P. Reply Br. to Board at 8, is misplaced.  In this case, the Board may not consider any new evidence that might exist that was not made a part of the record before the ALJ.

***The 10-year duration of Petitioner’s re-enrollment bar is not subject to ALJ (or Board) review.***As discussed above, the ALJ ultimately concluded that Petitioner’s challenge to the duration of the re-enrollment bar was outside the ALJ’s authority to review.  ALJ Decision at 8 (“The DAB has unambiguously explained that such a matter is beyond the scope of an ALJ’s review . . . .”); *see also id.* at 9 (“I may not otherwise review the duration of the re-enrollment bar.”).  The ALJ correctly quoted from the Board’s decision in *Linda Silva, P.A.*, DAB No. 2966 (2020), which made clear that CMS’s determination of the duration of a re-enrollment bar is not one of the enumerated “initial determinations” that an ALJ or the Board is empowered to review for error:

A decision by CMS or its contractor about how long to bar a revoked supplier from re-enrolling in Medicare, unlike the determination to revoke the supplier’s billing privileges, is not an appealable “initial determination” under 42 C.F.R. Part 498.  We therefore cannot consider or act upon Petitioner’s contention that the three-year re-enrollment bar was excessive in her circumstances.

*Id.* at 8 (quoting *Linda Silva*at 11 (internal citations omitted)).

On appeal, Petitioner appears to accept the ALJ’s conclusion.  RR at 9 (citing ALJ Decision at 9).  Nevertheless, Petitioner states that “the ALJ’s decision should be . . . overturned as it failed to determine that, as a matter of law, CMS’s decision to impose a 10-year re-enrollment bar in the present matter violated relevant Medicare rules and regulations.”  *Id.* (further asserting ALJ “failed to adequately address Petitioner’s argument . . . that it was clear legal error to impose the maximum re-enrollment bar for a revocation based solely on [section] 424.535(a)(10)(i)”).  Petitioner again argues that CMS’s re-enrollment bar decision, as governed by section 424.535(c)(1)(i), violates

**Page 20**

section 424.535(a)(10)(ii), which sets a revocation limit of “not more than 1 year for each act of noncompliance” by a “provider or supplier that meets the revocation criteria” from section 424.535(a)(10)(i).  Petitioner argues that an “act of noncompliance,” according to her interpretation of subregulatory guidance, applies to each records request letter, including those that include requests related to multiple Medicare beneficiaries and dates of service.  *Id.* at 10-11.  Following from this, Petitioner argues that the failure to respond to the request is just one “act of noncompliance,” for which “not more than 1 year” of revocation is allowed.  *Id*.

Petitioner therefore appears to challenge not the ALJ’s conclusion that decisions regarding the duration of a re-enrollment bar are unreviewable, but rather the ALJ’s conclusion that CMS did not commit legal error in interpreting and applying the phrase “act of noncompliance.”  *See* RR at 9 (arguing that the ALJ “incorrectly held that ‘[b]ecause Petitioner failed [to] provide any of the requested records, she was noncompliant with 20 requests for records [and] CMS was therefore authorized to impose a re-enrollment bar of up to one year per violation, capped at a maximum of 10 years’”) (quoting ALJ Decision at 8 (citations omitted)).  For its part, CMS argues, first, that this challenge is not reviewable for the reasons stated by the ALJ, and second, that “act of noncompliance” applies to a supplier’s failure to maintain or provide access to requested documents with respect to *each* identified beneficiary.  CMS Response at 11-12.  CMS argues that, to the extent that this challenge is reviewable, the re-enrollment bar of 10 years was based on a legally correct interpretation of section 424.535(a)(10)(ii), as applied to the re-enrollment bar provision at section 424.535(c)(1)(i).  *Id*. at 12-13.

Petitioner’s challenge on this issue is understandable, given that the ALJ, despite concluding that CMS’s decisions regarding the length of a re-enrollment bar are not subject to review, analyzed section 424.535(a)(10)(ii), provided an interpretation of “act of noncompliance,” and concluded there was no “legal error” in CMS’s re-enrollment bar determination.  ALJ Decision at 8-9.  Regardless of the ALJ’s conclusion, Part 498 regulations do not permit this type of inquiry by an ALJ, to the extent that such an inquiry alters or otherwise requires the review of the duration of the re-enrollment bar CMS has imposed.  Suppliers have the right to appeal only “initial determinations” by CMS “with respect to the matters specified in paragraph (b)” of section 498.3.  42 C.F.R. § 498.3(a)(1).  The ALJ correctly concluded that a CMS decision regarding the duration of a re-enrollment bar is not included on that list.  ALJ Decision at 8.  Board decisions fully support this conclusion.  *See, e.g.,* *Blair Allen Nelson, M.D.*, DAB No. 3024, at 13 (2020) (affirming ALJ’s refusal to review petitioner’s challenge to re-enrollment bar duration based on CMS’s alleged failure to consider “all relevant factors,” as “the duration of a re-enrollment bar is not an initial determination subject to review by the ALJ or the Board”); *Vijendra Dave, M.D.*at 8-11 (refusing to consider argument that length of re-enrollment bar was “excessive and contrary to regulations,” 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

**Page 21**

duration of a revoked supplier’s re-enrollment bar”); *accord*73 Fed. Reg. 36,448, 36,454 (June 27, 2008) (CMS stating in preamble to regulation that established the re-enrollment bar, “[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.”). Here, although Petitioner styles her challenge as an argument that the ALJ committed “legal error” in interpreting section 424.535(a)(10), Petitioner challenges the length of the re-enrollment bar CMS imposed, and asks the Board to reverse the ALJ Decision for failure to recognize this asserted legal error.  *See*RR at 9.  However, as the Part 498 regulations and longstanding Board precedent make clear, the ALJ (and the Board) lack the authority to review that agency determination for legal error, or to disturb that determination.

The ALJ’s conclusion with respect to the meaning of the phrase “act of noncompliance” in section 424.535(a)(10)(ii), and whether CMS committed any “legal error” in imposing a re-enrollment bar length of 10 years, is harmless error, however, as the ALJ ultimately, and correctly, concluded that Petitioner’s challenge to the duration of the re-enrollment bar was not an initial determination subject to ALJ review under Part 498 regulations.  For the same reason, we decline to review this agency determination, and we expressly do not reach the merits of the parties’ legal arguments in support of their positions.

Conclusion

We affirm the ALJ’s conclusion that CMS legally revoked Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10).  We also affirm the ALJ’s conclusion that Petitioner’s 10-year re-enrollment bar is not a determination subject to review under Part 498 regulations.

Endnotes

1  The record before the ALJ reflects that Petitioner used the former surname of Richards at the time that she enrolled in the Medicare program.  *See* CMS Ex. 10 (“Reconsidered Determination”), at 1 n.1.

2  We apply the Part 424 regulations that were in effect on August 18, 2020, when CMS’s contractor issued its initial revocation determination.  *See**John P. McDonough III, Ph.D., et al.*, DAB No. 2728, at 2 n.1 (2016).

3  “Eligible professional” means “any of the professionals specified in section 1848(k)(3)(B) of the Act.”  42 C.F.R. § 424.506(a).  Section 1848(k)(3)(B) of the Act defines “eligible professional” to include a physician and “a practitioner described in section 1842(b)(18)(C)” of the Act, which, in turn, defines “practitioners” to include, among others, nurse practitioners like Petitioner.  *Id.*

4  “NPI” (National Provider Identifier) is “the standard unique health identifier for health care providers (including Medicare suppliers).”  Medicare Program Integrity Manual (MPIM), Pub. 100-08, Ch. 10, § 10.1.1,  publicly available at https://www.cms.gov/regulations-and-guidance/guidance/manuals/internet-only-manuals-ioms-items/cms019033.

5  Effective November 4, 2019, CMS amended and restructured section 424.535(c) and created a new subsection (c)(1)(i), which extended the maximum re-enrollment bar length from three years to 10 years, and up to 20 years in certain circumstances.  *See*84 Fed. Reg. 47,794, 47,826, 47,854-56 (Sept. 10, 2019) (explaining the need to raise the maximum re-enrollment bar duration so that CMS could impose longer re-enrollment bars to address and deter more serious violations).  This rule took effect nine months before the date of Petitioner’s initial revocation determination.  Neither party disputes that the new re-enrollment bar regulation governs this appeal.

6  The factual information in this section is drawn from the ALJ Decision and the record before the ALJ and is not intended to add to or modify the ALJ’s findings.

7  The Provider Enrollment, Chain, and Ownership System, or “PECOS,” is a web-based Medicare enrollment management system by which providers and suppliers can apply to enroll in Medicare, revalidate and renew their enrollment, report changes to their enrollment records, and withdraw from or opt out of Medicare.  *See* 42 C.F.R. § 424.502 (defining “*PECOS*”); https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/Manage-Your-Enrollment.

8  UPICs, using a variety of methods, are “responsible for preventing, detecting, and deterring fraud, waste, and abuse in both the Medicare program and the Medicaid program.”  MPIM, Pub. 100-08, Ch. 4, § 4.2.2.1.

9  Appended to the revocation notice was another chart, titled “Enclosure A,” that is similar to the one CoventBridge had provided to Petitioner with the two records requests but which provided additional information.  *See* CMS Ex. 6, at 4.  This chart listed identifying information (name and NPI) of both Petitioner and the “billing providers” that supplied DMEPOS items, and the chart included specific dates of service (22 total) for the aforementioned 20 Medicare beneficiaries, with dates ranging from June 26, 2017, to March 20, 2018.  *Id*.

10  Contrary to Petitioner’s contention (*see*Request for Review (RR) at 5-6), the reconsidered determination does not state that CMS granted the “good cause waiver” based on Petitioner’s claim that she “never received timely notice.”  CMS issued the good cause waiver without explanation.  CMS Ex. 10, at 1.  Indeed, it is clear from the reconsidered determination that CMS was not persuaded by Petitioner’s argument that she never received adequate notice and therefore should be excused from her obligations under section 424.516(f)(2).  *See id.*at 3-4 (CMS rejected this argument noting that the Saginaw, Michigan address was listed on Petitioner’s PECOS enrollment record at the time the records requests and revocation notice were sent).

11  We construe CMS’s use of the phrase “individual act of noncompliance” as a reference to section 424.535(a)(10)(ii), which, as quoted above and discussed further below, states that any provider, supplier, physician, or other eligible professional who has not complied with the requirements of section 424.516(f), and thus is subject to revocation under section 424.535(a)(10)(i), “is subject to revocation for a period of not more than 1 year for each act of noncompliance.”  42 C.F.R. § 424.535(a)(10)(ii).

12  Petitioner does not state when exactly she believes the FBI seized ACC’s patient records, though she asserts that, “upon information and belief, the first request [dated and postmarked January 24, 2020] predates the subsequent seizure of these records by the United States Government.”  RR at 3.  The indictment at issue was filed in federal district court on January 31, 2020.  *See* CMS Ex. 11.

13  This Final Rule first established bases for revocation under 42 C.F.R. § 424.535.  The preamble language that Petitioner appears to cite in the brief states, in pertinent part:  “In considering whether to revoke enrollment and billing privileges in the Medicare program, we would consider the severity of the offenses, mitigating circumstances, program and beneficiary risk if enrollment was to continue, possibility of corrective action plans, beneficiary access to care, and any other pertinent factors.”  71 Fed. Reg. at 20,761.

14  To the extent that Petitioner’s assertions about her exemplary service and the hardship the revocation will have on the community of patients may be construed as a broader request for equitable relief, the Board has long held that ALJs and the Board have no authority to restore a supplier’s billing privileges on equitable grounds.  *See Daniel Wiltz, M.D. and Family Healthcare Clinic, APMC*, DAB No. 2864, at 13 (2018).

15  Specifically, Petitioner asserts an intent to “follow-up on this appeal with a Motion to Remand for Specific Discovery respectfully requesting that the [Board] remand the . . . matter to the ALJ and direct the ALJ to issue a subpoena for production of the medical records.”  RR at 8.  Although Petitioner has filed no such follow-up motion, we nevertheless review the request, as expressed in the Brief, and reject it for the reasons stated herein.
  
          /s/
        Christopher S. Randolph

                      Board Member
          /s/
        Susan S. Yim

                      Board Member
          /s/
        Karen E. Mayberry

                      Presiding Board Member Back to top
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