Frank B. Lee, M.D., DAB No. 3170 (2025)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

The Centers for Medicare & Medicaid Services (CMS) appeals the October 22, 2021 decision of an Administrative Law Judge (ALJ) in Frank B. Lee, M.D., DAB CR5967 (2021) (ALJ Decision). This case arose from CMS’s determination to (1) revoke Frank B. Lee, M.D.’s¹ Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(10)(i) for failure to meet the requirement in 42 C.F.R. § 424.516(f)(2) to maintain and provide access to documentation of the durable medical equipment, prosthetics, orthotics, and/or supplies (DMEPOS)² that CMS determined Dr. Lee ordered for 20 Medicare beneficiaries; and (2) impose a re-enrollment bar of 10 years under 42 C.F.R. § 424.535(c)(1)(i). The ALJ upheld the revocation. However, the ALJ concluded that CMS established, as part of its prima facie case, that Dr. Lee ordered DMEPOS for only three of the 20 beneficiaries whose DMEPOS records CMS’s program integrity contractor sought. Accordingly, the ALJ determined that CMS established three acts of noncompliance for which CMS could impose a maximum three-year re-enrollment bar (one year per act of noncompliance).

CMS asserts the ALJ erred in determining that CMS established that Dr. Lee was the ordering physician only as to three beneficiaries. CMS also asserts that its imposition of a 10-year re-enrollment bar was not subject to ALJ review; nevertheless, CMS urges the Board to review and reinstate the 10-year re-enrollment bar or, alternatively, conclude that CMS may impose a six-year re-enrollment bar, for two acts of noncompliance (failure to maintain documents; failure to provide access to them) with respect to each of

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the three beneficiaries. In opposition, Dr. Lee asserts, with little elaboration, that no “suspension” of his billing privileges is warranted. Dr. Lee also reprises his earlier argument that CMS must first carry its burden to prove that he ordered the subject DMEPOS for all 20 beneficiaries, but also appears to indicate that, should the Board find CMS’s arguments persuasive, he would accept a Board decision affirming the ALJ Decision, thus limiting the re-enrollment bar to three years.

We affirm the ALJ’s conclusion that CMS lawfully revoked Dr. Lee’s enrollment and billing privileges under section 424.535(a)(10)(i) for failure to comply with section 424.516(f)(2) as legally and factually sound but modify the ALJ’s rationale for that conclusion. We also conclude that Dr. Lee had no right to review of, and the ALJ had no authority to reach, CMS’s decision to impose a 10-year re-enrollment bar, as authorized by section 424.535(c)(1)(i). We therefore vacate that part of the ALJ Decision in which the ALJ reviewed and effectively reduced the 10-year re-enrollment bar, thus keeping in place the 10-year re-enrollment bar CMS imposed.

Legal Background

The Act authorizes CMS to administer the Medicare program, in part through contracts with private contractors who perform certain program functions, including the enrollment of providers and suppliers, on CMS’s behalf. Act §§ 1816, 1842, 1874A; 42 C.F.R. §§ 421.5(b), 421.404(c). A “supplier” of Medicare services – a term that includes physicians³ – must be enrolled in Medicare and maintain active enrollment status to receive payment for items and services covered by Medicare. 42 C.F.R. §§ 424.500, 424.505.⁴ “Enrollment” is the process CMS 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 1842(h)(9) of the Act provides:

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The Secretary [of Health and Human Services] 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). The implementing regulations in 42 C.F.R. § 424.535(a)(10) state:

(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.

42 C.F.R. § 424.535(a)(10)(i)-(ii).

The regulations in 42 C.F.R. § 424.516, in turn, set out certain requirements for enrolling in and maintaining active enrollment status in Medicare. As applicable here, section 424.516(f)(2) requires physicians who order, certify, or prescribe Medicare Part B items (such as DMEPOS) to maintain and provide access to documentation. Section 424.516(f)(2) provides:

(f) Maintaining and providing access to documentation.

* * * *

(2)(i) A physician or, when permitted, an eligible professional 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).

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Id. § 424.516(f)(2)(i).⁵

The “documentation” to which section 424.516(f)(2)(i) refers includes:

written and electronic documents (including the NPI⁶ 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).

The revocation of enrollment and billing privileges terminates the existing supplier agreement effective the date of revocation and bars the supplier from participating in Medicare from the effective date of revocation until the end of the re-enrollment bar. Id. § 424.535(b), (c)(1). Relevant here, CMS may bar the re-enrollment of a supplier whose enrollment and billing privileges are revoked for a minimum one year to a maximum 10 years. Id. § 424.535(c)(1)(i).⁷

The revocation of a supplier’s billing privileges is an “initial determination” from which the supplier may request a “reconsidered determination” by CMS or its contractor. Id. §§ 498.3(b)(17), 424.545(a), 498.5(l)(1), 498.22(a). A reconsidered 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). “Either of the parties” (CMS or the supplier) “has a right to request Departmental Appeals Board review of the ALJ’s decision.” Id. § 498.80.

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Case Background

Dr. Lee was enrolled in Medicare as a supplier until the revocation from which this appeal arose. ALJ Decision at 1; CMS Ex. 7.

By letter dated January 27, 2020, Qlarant Integrity Solutions, LLC (Qlarant), a CMS unified program integrity contractor (UPIC),⁸ asked Dr. Lee to produce, within 45 days, records concerning 20 Medicare beneficiaries for whom he had ordered DMEPOS items on various dates of service for the period from January 3, 2018 to February 16, 2018. CMS Ex. 4, at 1-2, 4 (chart listing, inter alia, beneficiaries’ names and dates of service). The letter stated:

The provider agreement to participate in the Medicare program requires you to submit all information necessary to support the durable medical equipment claims where you are listed as the ordering physician. In this respect, if certain records supporting the services rendered are at another facility, as the ordering provider you are responsible for obtaining those records for our review.

Id. at 2. Qlarant’s letter was delivered on January 27, 2020, to Dr. Lee’s correspondence address. Id. at 5; CMS Ex. 7, at 2.

Having received no response to its January 27, 2020 letter, Qlarant sent Dr. Lee a follow-up letter (dated July 15, 2020) asking him to submit the requested records. CMS Ex. 5, at 1-2, 4 (beneficiary chart identical to that in CMS exhibit 4, page 4). Qlarant reminded Dr. Lee that he, as “the ordering provider,” is “responsible for obtaining” the records “supporting the services rendered . . . at another facility.” Id. at 2. Qlarant warned Dr. Lee that if he did not submit the records within 15 days, “administrative action, including revocation, may be taken.” Id. at 2 (citing 42 C.F.R. §§ 424.516(f)(2), 424.535(a)(10)). The letter was delivered to Dr. Lee on July 15, 2020. Id. at 5.

By letter dated July 30, 2020, attorney D.T. (acting for Dr. Lee) notified Qlarant that:

Dr. Lee contracts with several telemedicine companies to provide telemedicine services for their patients. The patient encounters represented by the requested records were all via telemedicine, arranged by the telemedicine companies. After careful review, Dr. Lee has determined that he does not have possession or control of any records responsive to [Qlarant’s] request. He has, however, made efforts to obtain them. He has contacted the four telemedicine companies with which he does business.

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Two have said they do not have the requested records, and he has not yet heard back from the other two.

CMS Ex. 6, at 1. Attorney D.T. also stated that Dr. Lee “will continue his attempts to obtain the requested records” and, “[i]f and when he is able to obtain the records, he will provide them.” Id.

By initial determination dated August 18, 2020, Novitas Solutions, a CMS Medicare Administrative Contractor,⁹ notified Dr. Lee that his Medicare billing privileges would be revoked under 42 C.F.R. § 424.535(a)(10)(i), effective September 17, 2020, because he did not submit any of the requested records and thus failed to comply with 42 C.F.R. § 424.516(f). CMS Ex. 2, at 1. Novitas informed Petitioner that Petitioner would be barred from re-enrollment for 10 years, beginning 30 days after the postmark date of Novitas’s letter. Id. at 3 (citing 42 C.F.R. § 424.535(c)); 42 C.F.R. § 424.535(g)(1) (stating that, with exceptions inapplicable here, “a revocation becomes effective 30 days after CMS or the CMS contractor mails notice of its determination to the . . . supplier”).

Dr. Lee sought reconsideration, acknowledging receipt of Qlarant’s letters but disputing that he failed to respond to them. CMS Ex. 3, at 1. Dr. Lee stated that, on July 30, 2020, he (by D.T.) notified Qlarant that he had no records of any of the 20 beneficiaries, but explained that he attempted to obtain the records “from any entity with which he previously ha[d] done business” and which he “suspected may have the requested records, if they exist, in their possession,” but received no response from those entities. Id. at 1-2. Dr. Lee also argued that “unless CMS . . . first establish[ed] that the patients in question [were] actually [his] patients,” CMS could not revoke his billing privileges. Id. at 3 (underlining in original removed). Dr. Lee wrote:

There is [in] fact no evidence that these patients were Dr. Lee’s. The claim forms were not submitted by Dr. Lee. Dr. Lee was not reimbursed by CMS for seeing these patients. All we have is a list of patients who were allegedly provided DME ordered by Dr. Lee. In the typical case, these orders are not done by “wet ink” signature, but by electronic signature. There is no proof Dr. Lee ordered the DME as is required for revocation under 42 CFR [§ 424.]516(f).

Id. at 2 (Dr. Lee’s emphasis omitted). Citing section 424.516(f), Dr. Lee also asserted that CMS may lawfully impose a re-enrollment bar of only one year for each act of noncompliance. Id. at 3.

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By reconsidered determination dated October 9, 2020, CMS upheld the revocation pursuant to section 424.535(a)(10)(i) for failure to comply with section 424.516(f)(2), effective September 17, 2020. CMS Ex. 1, at 1, 3-4. CMS understood D.T.’s statements in his July 30, 2020 letter as Dr. Lee’s “admi[ssion] that he treated the relevant patients through his contracts with several telemedicine companies.” Id. at 3. CMS also stated that the fact that Medicare did not directly reimburse Dr. Lee had no bearing on the issue of whether he was the physician ordering or certifying the need for DMEPOS. Id. According to CMS, because Dr. Lee “admitted that he does not have possession or control of any of the requested medical records,” he failed to maintain the documents as required by section 424.516(f)(2)(i)(A). Id.; see also id. at 4. Moreover, CMS stated, since Dr. Lee did not produce the records, he also failed to provide access to them as required by section 424.516(f)(2)(i)(B). Id. at 3, 4.

On Dr. Lee’s argument that CMS may impose a re-enrollment bar of only one year per act of noncompliance, CMS wrote:

CMS considers each beneficiary for whom Dr. Lee failed to maintain and/or provide medical records constitutes an individual act of non-compliance. That is, in failing to provide the documentation requested by Qlarant, Dr. Lee committed 20 unique acts of non-compliance. As such, CMS imposed the maximum 10-year re-enrollment bar, pursuant to § 424.535(c)(1)(i).

Id. at 3 (CMS’s emphasis).

ALJ Proceedings and Decision

Dr. Lee¹⁰ timely requested a hearing. ALJ Decision at 4. CMS filed a combined pre-hearing brief and motion for summary judgment in its favor, urging the ALJ to uphold the revocation under section 424.535(a)(10)(i), along with eight exhibits. Id.; CMS Motion at 1; CMS Exs. 1-8. Dr. Lee filed a response brief and cross-motion for summary judgment in his favor, with two exhibits. ALJ Decision at 4; P. Br.; P. Exs. 1-2.

CMS requested to cross-examine (if a hearing was held) attorney D.T. and Dr. Lee whose declarations Dr. Lee submitted as Petitioner’s exhibit 1 (D.T.’s declaration) and Petitioner’s exhibit 2 (Dr. Lee’s declaration). ALJ Decision at 4. Dr. Lee elected not to cross-examine W.N., Lead Investigator, Qlarant, whose declaration (CMS Ex. 8) CMS submitted as W.N.’s written direct testimony. ALJ Decision at 4.

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CMS declined to file a brief in reply to Dr. Lee’s response brief but filed a response to Dr. Lee’s cross-motion for summary judgment and four additional exhibits (CMS Exs. 9-12), one of which was the declaration of L.O., Medical Review manager, Qlarant (CMS Ex. 12). ALJ Decision at 4. In submitting additional exhibits, CMS stated that Qlarant recently provided CMS the new evidence (CMS Exs. 9-11), which, CMS asserted, “further show[ed] that Dr. Lee was the ordering physician for the claims in question.” CMS Response Brief to ALJ at 5. Dr. Lee did not reply to CMS’s response to his cross-motion, object to CMS exhibits 9-12, or seek to cross-examine L.O. ALJ Decision at 4.

Finding material facts in dispute, the ALJ denied the summary judgment motions and set the case for hearing on May 25, 2021. ALJ Decision at 4; Notice of Hearing at 1.

Dr. Lee raised two evidentiary objections (one general; one specific to CMS exhibit 6), challenging CMS’s exhibits to the extent CMS offered them as proof that he ordered the DMEPOS in question. First, Dr. Lee objected to “incompetent, hearsay and conclusory statements of CMS employees, contractors and records to the extent that such supposed summary judgment evidence merely suggests that some third party wrote Dr. Lee’s name as the prescriber.” P. Br. at 3. The ALJ overruled the objection for failure to “specify any exhibits” and stated that he would consider in his written decision the weight to accord to hearsay in CMS’s evidence.¹¹ Notice of Hearing at 2. Second, Dr. Lee objected to attorney D.T.’s July 30, 2020 letter to Qlarant (CMS Ex. 6), maintaining that, by that letter, he did not admit to having ordered DMEPOS and submitted the letter only to facilitate negotiation with Qlarant. P. Br. at 3. In any event, Dr. Lee asserted that D.T. had no first-hand knowledge of the matters discussed in the letter. Id. The ALJ overruled the objection to CMS exhibit 6, stating that “this case was not initiated until a CMS contractor revoked Petitioner’s Medicare enrollment and billing privileges in an August 18, 2020 initial determination” (CMS Ex. 2) and, thus, D.T.’s “letter was written in response to a request for documentation supporting claims that had been submitted to the Medicare program” before revocation and that D.T.’s response “is material to the basis for revocation in this case.” Notice of Hearing at 2. The ALJ admitted CMS’s exhibits 1-12, and “provisionally admit[ted]” Petitioner’s exhibits 1 and 2 (D.T.’s and Dr. Lee’s declarations). Id.

CMS later withdrew its earlier request to cross-examine Dr. Lee. ALJ Decision at 4; CMS’s May 6, 2021 notice. At the hearing convened to permit CMS to cross-examine

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D.T., the ALJ stated that D.T.’s declaration (P. Ex. 1) and Dr. Lee’s declaration (P. Ex. 2) were “fully admitted into the record.” Hearing Transcript (Tr.) at 3. The parties submitted post-hearing briefs; CMS filed a post-hearing reply brief. ALJ Decision at 4.

On October 22, 2021, the ALJ issued a decision upholding the revocation under 42 C.F.R. § 424.535(a)(10)(i) for failure to comply with 42 C.F.R. § 424.516(f)(2). Id. at 2, 15-16. However, the ALJ effectively reduced the re-enrollment bar to three years. Id. at 2 (stating that, “as a matter of law, the reenrollment bar in this case cannot exceed three years”), 16 (stating that “the maximum length of the reenrollment bar is limited to three years”).

The ALJ made the following six numbered findings and conclusions:

1. In January 2018, Petitioner electronically signed written orders for back and wrist braces for three Medicare beneficiaries. The written orders have Petitioner’s name and [NPI] on them. The written orders also include an electronic signature that could only be applied with a unique login password.
2. Petitioner received a letter dated January 27, 2020, from an investigator with a UPIC requesting medical documentation from Petitioner’s records related to 20 Medicare beneficiaries listed on an attachment to the letter. Petitioner did not respond to that request.
3. Petitioner received a letter dated July 15, 2020, from another UPIC investigator, again requesting medical documentation from Petitioner’s records related to the 20 Medicare beneficiaries listed on an attachment to the letter. This letter advised Petitioner that CMS could revoke Petitioner’s enrollment in the Medicare program if the UPIC did not receive the requested documents within 15 days. Petitioner’s attorney responded that Petitioner did not have the requested documents. Petitioner also informed the UPIC that he had contracts with four telehealth companies and that Petitioner was attempting to determine which companies had the beneficiaries’ records.
4. CMS made a prima facie showing that Petitioner ordered DMEPOS for three Medicare beneficiaries and that Petitioner did not maintain records for those beneficiaries and did not provide those records to the UPIC upon request. Petitioner failed to overcome CMS’s prima facie showing with sufficient evidence.
5. CMS was authorized to revoke Petitioner’s Medicare enrollment and billing privileges under 42 U.S.C. § 1395u(h)(9) [section 1842(h)(9) of

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the Act] and 42 C.F.R. § 424.535(a)(10) because Petitioner failed to maintain copies of medical records for three beneficiaries for whom Petitioner ordered DMEPOS and failed to provide documentation related to those orders as requested by the UPIC.

6. Petitioner’s reenrollment bar cannot exceed three years because the record only supports three acts of noncompliance based on the three beneficiaries for which Petitioner signed the Written Orders.

Id. at 5, 6, 7, 8, 13, 15 (ALJ’s bolding and italics removed).

In sum, the ALJ concluded that CMS established that Dr. Lee was the ordering or prescribing physician for DMEPOS furnished to only three of the 20 beneficiaries whose records Qlarant requested; that Dr. Lee did not maintain and provide access to the records pertaining to the three beneficiaries; and CMS therefore lawfully revoked his enrollment and billing privileges. However, the ALJ concluded that CMS could only bar Dr. Lee from re-enrollment for three years, that is, one year per proven act of noncompliance.

The Parties’ Arguments Before the Board

CMS appeals the ALJ Decision. 42 C.F.R. § 498.80 (“Either of the parties has a right to request [Board] review of the ALJ’s decision. . . .”). CMS urges us to uphold the ALJ’s conclusion that CMS lawfully revoked Dr. Lee’s enrollment under 42 C.F.R. § 424.535(a)(10)(i). However, CMS asserts that the ALJ “misapplied” the burden of proof, holding CMS to a “heightened burden” “in determining that CMS did not present sufficient evidence that [Dr. Lee] was the ordering physician for 17 of the 20 beneficiaries to make its prima facie case of noncompliance,” and erroneously weighed the evidence. CMS’s Request for Review (CMS Br. to Board) at 1, 9-10. CMS also asserts that Dr. Lee had no right to ALJ review of the 10-year re-enrollment bar and, thus, the ALJ erred in reaching the issue and reducing the bar. Id. at 19-22. Nevertheless, CMS asks us to determine, alternatively, that the ALJ erroneously found that Dr. Lee “committed only three acts of noncompliance, instead of six, and ruled that [his] reenrollment bar cannot exceed three years.” Id. at 1; id. at 22-25 (asserting that Dr. Lee committed two acts of noncompliance for each of the three beneficiaries, thus supporting a six-year re-enrollment bar). CMS asks us to either reverse the ALJ’s findings and conclusions unfavorable to CMS as to the records of 17 beneficiaries and then reinstate the 10-year re-enrollment bar, or, alternatively, determine that CMS may impose a six-year re-enrollment bar. Id. at 1-2, 24-25.

In response, Dr. Lee maintains that “[t]here should be no suspension,” which we understand as meaning that his billing privileges should not have been revoked. Petitioner’s Response to CMS Request for Review and Brief in Support of Appeal (P. Br. to Board) at 1. However, Dr. Lee also maintains that “if there is any evidence at all in the

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record, there is only 3 records and not 20.” Id. Dr. Lee thus maintains even if the Board is inclined to disturb the ALJ Decision, the Board should leave undisturbed the ALJ’s determination that CMS met its burden of proof only as to the records concerning three beneficiaries.

According to Dr. Lee, “just because electronic government records show a person to be a patient of a particular doctor, does not make it true.” Id. at 2 (emphasis omitted). Dr. Lee posits that the “government electronic record could be wrong” for numerous reasons (e.g., “[m]aybe someone at the billing company just made a mistake and entered the wrong information”). Id. at 3; id. at 5 (asserting that electronic records could be “incorrect and unreliable”). The issue, according to Dr. Lee, is not whether CMS’s records show that the 20 beneficiaries received DMEPOS based on “orders containing [Dr. Lee’s] credentials” because “[n]o one disputes” that; the issue is “whether or not [those beneficiaries] were actually [his] patients.” Id. at 3 (underlining in original removed). Dr. Lee thus continues to dispute what he views as CMS’s wrongly assuming that he was the ordering physician, arguing that “the burden of proof should not be upon [him] to ‘prove a negative’” when CMS “did not even produce the records for 17 out of the 20” beneficiaries. Id. at 3-5. Lastly, Dr. Lee suggests that CMS failed to make its case in part because CMS did not call a single beneficiary or other witness with first-hand knowledge to testify that Dr. Lee ordered the DMEPOS. Id. at 5-6.

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. SeeGuidelines – Appellate Review of Decisions of Administrative Law Judges Affecting a Provider’s or Supplier’s Enrollment in the Medicare Program (Guidelines), “Completion of the Review Process,” ¶ (c).¹²

Analysis

We agree with the ALJ that, as a threshold matter, CMS must prove as part of its prima facie case that Dr. Lee ordered DMEPOS, the records of which Qlarant sought. We also agree with the ALJ’s ultimate conclusion that CMS proved that Dr. Lee ordered DMEPOS and that he failed to comply with 42 C.F.R. § 424.516(f)(2)’s document maintenance and access requirements and, thus, lawfully revoked Dr. Lee’s enrollment

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and billing privileges under 42 C.F.R. § 424.535(a)(10)(i). However, we modify the ALJ’s assessment of the evidence and rationale underpinning that correct conclusion.¹³

As we explain in section I below, by determining that CMS made its prima facie case on the predicate factual issue of whether Dr. Lee ordered the DMEPOS for only three beneficiaries, the ALJ appears to have conflated an issue relevant to whether the basis for revocation under section 424.535(a)(10)(i) exists (which could be established based on at least one act of noncompliance), with the separate, albeit related, issue of the number of acts of noncompliance with section 424.516(f)(2), which is needed to set the length of the re-enrollment bar to be imposed once the basis for revocation is met. To be clear, to establish its prima facie case for revocation under section 424.535(a)(10)(i), CMS had to show, at minimum, that Dr. Lee was in fact the ordering physician in at least one instance with respect to the DMEPOS that were the subject of Qlarant’s document requests. The number of beneficiaries for whom, or the number of instances in which, Dr. Lee was the ordering physician is germane to determining the number of acts of noncompliance, because once CMS decides to exercise its discretion to revoke billing privileges under section 424.535(a)(10)(i), it must impose a re-enrollment bar of one year per act of noncompliance.

In section II, we address the ALJ’s assessment of the evidence concerning whether Dr. Lee was the ordering physician, which is the main subject of the parties’ dispute. We determine that CMS needed to establish, as part of its prima facie case, that Dr. Lee ordered DMEPOS for at least one beneficiary Qlarant identified. Nevertheless, we also determine that CMS showed that Dr. Lee ordered DMEPOS for all 20 beneficiaries. Dr. Lee must bear the ultimate burden to prove, by a preponderance of the evidence, that he in fact complied with the applicable requirements to defeat revocation but has not met that burden. Accordingly, CMS lawfully revoked his billing privileges under section 424.535(a)(10)(i).

In section III, we discuss the 10-year re-enrollment bar CMS imposed in accordance with section 424.535(c)(1)(i), as we must, because CMS alleges that the ALJ erred in reaching the issue of the re-enrollment bar and asks us to remedy that error. The Federal Register preamble language associated with the 2019 regulatory revisions that were in effect on August 18, 2020, the date of revocation of Dr. Lee’s enrollment, makes clear that a supplier has no right to review under 42 C.F.R. Part 498 of the duration of a re-enrollment bar imposed under section 424.535(c)(1)(i) (as here) and which (as here)

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could range between one and 10 years.¹⁴ We thus conclude that the ALJ erred in reaching the issue of the length of the re-enrollment bar and vacate the ALJ’s conclusion that CMS may impose on Dr. Lee a maximum three-year re-enrollment bar. Our vacating the ALJ’s conclusion on the re-enrollment bar leaves intact CMS’s imposition of the 10-year re-enrollment bar.¹⁵

If the ALJ had no authority to review the re-enrollment bar, neither does the Board. In rendering void the ALJ’s reduction of the re-enrollment bar, we are simply addressing the error and making clear that CMS’s lawful imposition of a re-enrollment bar in accordance with section 424.535(c)(1)(i) is not reviewable. Our discussion of the re-enrollment bar here therefore does not depart from the Board’s earlier decisions, including those arising from revocation under section 424.535(a)(10), in which the Board consistently stated that the re-enrollment bar is not reviewable.

I. The issue of whether a basis for revocation under 42 C.F.R. § 424.535(a)(10)(i) exists does not turn on the number of beneficiaries whose DMEPOS records CMS or its contractor requested, but on whether the supplier failed to comply with section 424.516(f)(2) in at least one instance.

A physician-supplier who ordered DMEPOS billed to Medicare must do two things:

• “Maintain,” for a period of seven years from the date of service, certain “documentation” as described in section 424.516(f)(2)(ii), which includes written or electronic records related to written orders for DMEPOS.
• Provide CMS or its contractor “access” to that documentation “[u]pon request.”

42 C.F.R. § 424.516(f)(2)(i)(A), (B); George M. Young, M.D., DAB No. 2750, at 8 (2016). If the physician-supplier “did not comply with the documentation or CMS access requirements specified in [section] 424.516(f),” then CMS may revoke enrollment and billing privileges. 42 C.F.R. § 424.535(a)(10)(i).

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We note that, in this case and others that came before the Board during the last several years arising from revocation under section 424.535(a)(10), CMS (through its contractors) appears to have been consistent, generally speaking, in requesting records for DMEPOS items purportedly ordered for 20 beneficiaries.¹⁶See Heidi Woody, NP, DAB No. 3102, at 4 (2023); Chintapalli, DAB No. 3122, at 4, n.7;¹⁷Stephen Daniel Sasser, M.D., DAB CR 6190, at 2 (2022).¹⁸

However, to be clear, the fact that CMS or its contractor requested records concerning 20 beneficiaries itself is not directly germane to the initial question of whether the basis for revocation under section 424.535(a)(10)(i) exists. By its terms, section 424.516(f)(2) does not prescribe any specific number of records or of beneficiaries whose records the ordering physician must maintain and produce. It does not include the word “act” or the term “act of noncompliance.” Moreover, section 424.535(a)(10)(i) does not condition CMS’s authority to revoke under that regulation depending on a physician’s failure to maintain and provide access to DMEPOS records associated with any specific number of beneficiaries, or the number of records, or on any specific number of acts of failure to comply with section 424.516(f)(2). It is conceivable (though, as a practical matter, unlikely) that an enrolled physician could have ordered DMEPOS for which Medicare payment was claimed and made for a single beneficiary for a single date (or multiple dates) of service that fell within the seven-year period. If that physician failed to maintain, for seven years, the records of the ordered DMEPOS, and did not provide access to any records on request, then under the plain language of section 424.535(a)(10)(i), CMS could proceed to revocation.

In short, a determination of whether the basis for revocation under section 424.535(a)(10)(i) exists itself does not turn on the number of beneficiaries whose DMEPOS records CMS or its contractor requested. The question is, essentially, whether the supplier failed to comply with section 424.516(f)(2) in at least one instance.

Once noncompliance with section 424.516(f)(2) is shown, thereby establishing a basis for revocation under section 424.535(a)(10)(i), and if CMS makes the discretionary decision to revoke (as CMS “may” revoke, see section 424.535(a)), the specific number of acts of

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noncompliance with section 424.516(f)(2) must be determined to set a re-enrollment bar period. 42 C.F.R. § 424.535(a)(10)(ii) (“A . . . supplier that meets the revocation criteria specified in paragraph (a)(10)(i) . . . is subject to revocation for a period of not more than 1 year for each act of noncompliance”); see also Act § 1842(h)(9) (mandating the barring of a supplier who failed to comply with document maintenance and access requirements from re-enrolling in Medicare for no more than one year per act of noncompliance).

CMS’s language in its reconsidered determination bears repeating. CMS stated:

CMS considers each beneficiary for whom Dr. Lee failed to maintain and/or provide medical records constitutes an individual act of non-compliance. That is, in failing to provide the documentation requested by Qlarant, Dr. Lee committed 20 unique acts of non-compliance. As such, CMS imposed the maximum 10-year re-enrollment bar, pursuant to § 424.535(c)(1)(i).

CMS Ex. 1, at 3 (CMS’s emphasis).¹⁹ Notably, CMS conveyed that the number of acts of noncompliance is pertinent to determining the number of years a supplier could be barred from re-enrolling once CMS decides to proceed with revocation. The ALJ appears to have agreed with CMS position on this issue, as the ALJ stated:

I agree with CMS’s reading of the statute and regulation. The UPIC requested documents from Petitioner for 20 separate beneficiaries based on 20 separate claims that Medicare had received. Petitioner’s failure to maintain and produce records for the UPIC was a separate act of noncompliance for each beneficiary.

ALJ Decision at 16 (first citing Act § 1842(h)(9); and then citing 42 C.F.R. § 424.535(a)(10)).

II. The ALJ’s determination that CMS established that Dr. Lee did not comply with 42 C.F.R. § 424.516(f)(2)’s document maintenance and access requirements, and thus that CMS lawfully revoked Dr. Lee’s enrollment and billing privileges under 42 C.F.R. § 424.535(a)(10)(i), is supported by substantial evidence.

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A. CMS must first come forward with evidence sufficient to establish its prima facie case for revocation; once CMS does so, as it did here, then the supplier must bear the ultimate burden to show compliance with the governing authorities.

Cases arising from the revocation of enrollment (such as this one) are governed by the burden of proof framework that applies to other cases reviewed in accordance with the regulations in 42 C.F.R. Part 498, such as cases arising from skilled nursing facility appeals of CMS’s imposition of civil money penalties and other sanctions for noncompliance with Medicare participation requirements. See Adora Healthcare Servs., Inc., DAB No. 2714, at 4-5 (2016) (first citing Promptcare New England Respiratory LLC, DAB No. 2673, at 7-8 (2016) (cited in ALJ Decision at 9-10); and then citing Ronald J. Grason, M.D., DAB No. 2592, at 5 (2014), aff’d, No. 2:14-CV-02267 (C.D. Ill. Feb. 23, 2016), aff’d, 659 F. App’x 899 (7th Cir. 2016)), recon. denied, DAB Ruling 2017-4 (May 18, 2017); MediSource Corp., DAB No. 2011, at 3 (2006) (cited in ALJ Decision at 10); Grason, DAB No. 2592, at 5; Evergreene Nursing Care Ctr., DAB No. 2069, at 7 (2007) (setting out the burden of proof framework in a case arising from appeal by a skilled nursing facility), appeal dismissed per consent motion to dismiss with prejudice, No. 3:07-CV-00024 (W.D. Va. June 16, 2008); Mercy Home Care, Sioux City, DAB No. 3044, at 16-17 (2021) (setting out the same, in a case arising from appeal by a home health agency). Applying that framework to this case, before an ALJ, “CMS has the burden of coming forward with evidence that establishes a prima facie case that the cited basis for the revocation exists. If CMS meets this burden, [the supplier] then has the burden to prove [his] case, that is, to rebut the basis for the revocation, by a preponderance of the evidence.” Adora at 5. “Preponderance of the evidence” means that “it is more likely than not that [the supplier] was in substantial compliance” with applicable requirements. Claiborne-Hughes Health Ctr., DAB No. 2223, at 4 (2008), aff’d, 609 F.3d 839 (6th Cir. 2010), rehearing denied (Aug. 20, 2010).

“A party establishes a prima facie case by introducing enough probative evidence to establish a proposition in the absence of contrary evidence.” Hearthside Care Ctr., DAB No. 1741, at 4 (2000). “CMS makes a prima facie showing of noncompliance if the evidence CMS relies on is sufficient to support a decision in its favor absent an effective rebuttal.” Evergreene, DAB No. 2069, at 7 (citing Hillman Rehabilitation Ctr., DAB No. 1663, at 8 (1998), aff’d, No. 98-3789 (GEB) (D.N.J. May 13, 1999)). The opposing party “can overcome CMS’s prima facie case either by rebutting the evidence upon which that case rests, or by proving facts that affirmatively show substantial compliance.” Id. (citing Tri-County Extended Care Ctr., DAB No. 1936 (2004), aff’d, 157 F. App’x 885 (6th Cir. 2005)). Importantly, “[a] prima facie case does not amount to an irrebuttable presumption, but rather to evidence sufficient to support a decision in a party’s favor, absent contrary evidence.” Hillman, DAB No. 1663, at 7. “If the opposing party presents contrary evidence,” then the ALJ must consider all the evidence to render a decision. Id.

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To make its prima facie case for noncompliance with section 424.516(f)(2) to establish a basis for revocation under section 424.535(a)(10)(i), CMS had to show before the ALJ that Dr. Lee (1) ordered DMEPOS (in at least one instance); and (2) failed to maintain for seven years, and provide access to, the records concerning the DMEPOS of the type described in section 424.516(f)(2)(ii).

Before the ALJ, Dr. Lee asserted that CMS first must show, but did not show, that he was in fact the physician who ordered the DMEPOS in question before the ALJ considers whether he failed to comply with section 424.516(f)(2). P. Post-Hr’g Br. at 2 (“[T]here is not one scintilla of evidence to support CMS’s claim that Dr. Lee ‘ordered’ the services for the patients in question, nor that these patients were in fact, patients of Dr. Lee.”) (emphasis omitted). The ALJ agreed that CMS must make such a showing as part of its prima facie case. ALJ Decision at 10 (“Petitioner disputes that he treated the beneficiaries in question and ordered DMEPOS for them. Therefore, it is on that issue I must determine if CMS submitted prima facie evidence.”).

The ALJ did not err in first considering whether Dr. Lee ordered any DMEPOS as Qlarant asserted he did by its document requests because, if Dr. Lee was not in fact the ordering physician with respect to any DMEPOS associated with the beneficiaries identified in Qlarant’s list, then CMS would not have a basis to charge Dr. Lee for failure to maintain and provide access to the records of the DMEPOS and, thus, would not have a basis to revoke his enrollment under section 424.535(a)(10)(i). However, to be clear, the operative regulations do not require that, to be found noncompliant with section 424.516(f)(2), the ordering physician must have failed to maintain and provide access to the records for any specific number of beneficiaries; there only must be evidence of at least one act of noncompliance with section 424.516(f)(2) requirements.²⁰

B. CMS proved that Dr. Lee ordered DMEPOS.

i. The ALJ’s analysis of the evidence concerning whether Dr. Lee ordered DMEPOS

The ALJ first considered Qlarant’s list of 20 beneficiaries, accompanied by Qlarant investigator W.N.’s January 13, 2021 declaration (CMS Ex. 8) attesting that she had access to durable medical equipment claims data provided by CMS; that Dr. Lee was the “referring/ordering provider” for four entities (including, specifically, Nationwide Medical, LLC and Heart Homecare, LLC); and that the four entities submitted, in January

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and February 2018, claims for Medicare payment for 20 beneficiaries for whom Dr. Lee ordered DMEPOS and who were identified in Qlarant’s beneficiary list. ALJ Decision at 10 (discussing W.N. declaration); CMS Ex. 8 ¶¶ 4-6. However, the ALJ found W.N.’s testimony unreliable, as the ALJ stated:

Inexplicably, CMS did not provide a copy of the electronic records on which the list and the testimony were based. This failure to submit documentary support for testimony that was based on a review of records is insufficient to be deemed as prima facie evidence that Petitioner issued the orders for DMEPOS for the 20 beneficiaries in question.

ALJ Decision at 10.

The ALJ also considered attorney D.T.’s July 30, 2020 letter in response to Qlarant’s follow-up request (CMS Ex. 6), January 25, 2021 declaration (P. Ex. 1), and hearing testimony. The ALJ found the differences between the contents of the letter and D.T.’s declaration concerning because, in denying reconsideration, “[t]he CMS hearing officer relied almost exclusively” on the letter to conclude that Dr. Lee admitted that “he treated the relevant patients through his contracts with several telemedicine companies.” ALJ Decision at 10-11 (quoting CMS Ex. 1, at 3). Ultimately, the ALJ found it “clear” from the letter “that neither [D.T.] nor [Dr. Lee] knew whether the telemedicine companies had the records sought by the UPIC,” and D.T. “was conveying to the UPIC that [Dr. Lee] was still inquiring with the telemedicine companies to find out if they had the records.” Id. at 11 (citing CMS Ex. 6). However, the ALJ concluded that D.T.’s declaration and testimony denied any intention “to admit that [Dr. Lee] had treated the 20 beneficiaries in question” and explained that in preparing the letter D.T. had relied on CMS’s statement that the patients were legitimate. Id. The ALJ found D.T.’s and Dr. Lee’s hearing testimony consistent in denying that Dr. Lee ever had told D.T. that records existed for the beneficiaries on the UPIC list or that Dr. Lee had provided services to those beneficiaries. Id. (citing Tr. at 14). The ALJ also acknowledged D.T.’s further hearing testimony that he never saw medical records associated with those beneficiaries. Id. (citing Tr. at 14).

Considering D.T.’s letter to Qlarant, and D.T.’s and Dr. Lee’s testimony, the ALJ determined that Dr. Lee did not admit that he ordered DMEPOS for the 20 beneficiaries identified in Qlarant’s list, and that D.T.’s letter did not “suffice[ ] for CMS to meet its burden to make a prima facie showing that Petitioner ordered DMEPOS for the 20 beneficiaries at issue.” Id.

The ALJ also considered CMS’s evidence of claim records, which included three January 2018 written orders for back (lumbar-sacral) and wrist braces for three beneficiaries, each bearing Dr. Lee’s name, NPI, and electronic signature, together with the March 19, 2021 declaration of L.O., a Qlarant Medical Review manager. ALJ Decision at 5-6 (citing and

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discussing CMS Exs. 9-11); see CMS Ex. 9, at 4-5; CMS Ex. 10, at 4-5; CMS Ex. 11, at 7-8; CMS Ex. 12 (L.O. declaration). L.O. attested that the claim records in CMS exhibits 9-11, which Nationwide Medical, LLC and Heart Homecare, LLC provided to Qlarant, supported Medicare claims for DMEPOS provided to three of the beneficiaries identified in Qlarant’s list sent to Dr. Lee. CMS Ex. 12, at ¶¶ 5-8. L.O. also stated that CMS exhibits 9-11 show Dr. Lee’s electronic signature accompanied by his “attestation” and “entry of [his] unique login account password.” Id. ¶¶ 9-10.

The ALJ found the documents in CMS exhibits 9-11 particularly “reliable” and “sufficient for CMS to meet its prima facie evidence burden as it related to three beneficiaries and three Written Orders” because they were accompanied by L.O.’s testimony. ALJ Decision at 11-12; id. at 8 (finding and conclusion 4, stating, in part, “CMS made a prima facie showing that Petitioner ordered DMEPOS for three Medicare beneficiaries”) (ALJ’s emphases omitted). The ALJ noted, in particular, that the DMEPOS orders in CMS exhibits 9-11 “are true and accurate copies of documents [Qlarant] received from Medicare suppliers Nationwide Medical, LLC and Heart Homecare, LLC.” Id. at 11 (citing CMS Ex. 12 ¶¶ 5, 7). The ALJ also noted that CMS exhibits 9-11 included Qlarant’s letters to both entities acknowledging the submission of Medicare claims. Id. (stating that “[t]he Written Orders are part of each claim submission”). The ALJ further found that the electronic signatures on the orders “could only be applied with a unique login password.” Id. at 5 (ALJ’s emphases omitted); see CMS Ex. 9, at 6; CMS Ex. 10, at 6; CMS Ex. 11, at 9. Moreover, the ALJ found that, in electronically signing the orders, Dr. Lee certified that he determined that the items he ordered for the three beneficiaries were medically reasonable and necessary. ALJ Decision at 6; see CMS Ex. 9, at 5; CMS Ex. 10, at 5; CMS Ex. 11, at 8.

The ALJ determined that the DMEPOS “orders are the only evidence in the record sufficient to meet [CMS’s] burden,” but also stated that his determination “should not be construed as implying that CMS can only meet its burden in similar cases by providing the orders issued by a physician.” ALJ Decision at 12, n.2. The ALJ stated, “[H]ad CMS filed documentation from its records, that may have been sufficient to meet [its] burden . . . .” Id.

ii. Our assessment of the evidence and the ALJ’s analysis

“The Part 498 regulations contemplate two levels of review of agency action – de novo review and decision . . . by an ALJ, and then appellate review of the ALJ decision . . . by the Board.” Life Care Ctr. of Kirkland, DAB Ruling No. 2020-3, at 5, n.3 (June 29, 2020). The ALJ, as the factfinder, first assesses the evidence de novo; on appeal, the Board reviews the ALJ’s assessment of the evidence to determine “whether the ALJ decision is supported by substantial evidence in the record as a whole.” See Guidelines, “Completion of the Review Process,” ¶ (c). “Substantial evidence” means “such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.”

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Richardson v. Perales, 402 U.S. 389, 401 (1971) (quoting Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938)).

“The ‘substantial evidence’ standard is deferential.” Glenoaks Nursing Ctr., DAB No. 2522, at 6 (2013). “Under the substantial evidence standard, the Board does not re-weigh the evidence or overturn an ALJ’s choice between two fairly conflicting views of the evidence; instead, the Board determines whether the contested finding could have been made by a reasonable fact-finder tak[ing] into account whatever in the record fairly detracts from [the] weight of the evidence that the ALJ relied upon.” Douglas Bradley, M.D., DAB No. 2663, at 5 (2015) (internal quotation marks omitted) (first quoting Universal Camera Corp. v. NLRB, 340 U.S. 474, 488 (1951); and then citing Golden Living Ctr. - Frankfort, DAB No. 2296, at 9-10 (2009), aff’d, 656 F.3d 421 (6th Cir. 2011)), appeal dismissed per stipulation, No. 2:15-CV-08835 (D. N.J. June 2, 2017). Consistent with that standard, the Board defers to the ALJ’s credibility of witnesses and weighing of evidence absent compelling reasons for not doing so. See Ridgecrest Healthcare, DAB No. 2598, at 10 (2014) (citing Van Duyn Home & Hosp., DAB No. 2368, at 10-11 (2011), citing Koester Pavilion, DAB No. 1750, at 16, 21 (2000)); Atty’s Parti Expo, Inc., DAB No. 2925, at 7 (2019).

Here, however, there are several compelling reasons we are not inclined to defer fully to the ALJ’s assessment of the evidence.

First, although it was not error for the ALJ to weigh the adequacy of CMS’s evidence of each alleged instance of noncompliance, it also was not necessary. The ALJ could have determined that CMS made its prima facie case for revocation on the bare fact that CMS showed Dr. Lee ordered DMEPOS for at least one beneficiary included in Qlarant’s list and in the absence of any evidence that Dr. Lee maintained and provided access to the relevant records concerning that beneficiary.

Second, we question the underlying assumption in the ALJ’s analysis and Dr. Lee’s arguments that the only way CMS could make its prima facie case was to produce claim records, namely, the DMEPOS orders like those in CMS exhibits 9-11. Neither Dr. Lee nor the ALJ provided satisfactory explanations or cited legal authority for their expectation that CMS must establish a prima facie case for every beneficiary where, as here, its contractor asked for the records for multiple beneficiaries, and that CMS could only do so by producing claim records, such as DMEPOS orders, for every beneficiary.

Third, the ALJ’s rejection of W.N.’s testimony (CMS Ex. 8) raises concerns of improper burden shifting. The ALJ rejected W.N.’s testimony only because, unlike L.O.’s testimony, W.N.’s was not accompanied by “electronic records on which [Qlarant’s beneficiary] list and the testimony were based” (possibly meaning claim records like those in CMS exhibits 9-11 that would establish a direct link between Dr. Lee as the

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ordering physician and the DMEPOS Medicare paid for).²¹See ALJ Decision at 10. In rejecting W.N.’s testimony as altogether insufficient and unreliable in the absence of claim records, the ALJ effectively held CMS to producing the very documents that section 424.516(f)(2) requires the supplier to maintain and produce. There is good reason for the regulation to impose that burden on the supplier: to enable CMS or its contractor to verify whether the claim was proper, and that the supplier was qualified to order, refer, or prescribe the items and services Medicare paid for. See Proposed Rule, 81 Fed. Reg. 10,720, 10,732 (March 1, 2016).²² Dr. Lee, not CMS, was obligated to produce the relevant records described in section 424.516(f)(2)(ii).

Fourth, the ALJ’s rejection of W.N.’s testimony is insupportable to the extent the rejection was based on concerns of uncorroborated hearsay testimony “based on a review of records” that were not in evidence. See ALJ Decision at 10. “The Board has long held that hearsay is admissible in administrative proceedings generally and can be probative on the issue of the truth of the matter asserted, where sufficient indicia of reliability are present.” Summit S. Shah, M.D., DAB No. 2836, at 5-6 (2017) (citing Britthaven, Inc., d/b/a Britthaven of Smithfield, DAB No. 2018, at 3 (2006) (and cases cited therein)); see Florence Park, DAB No. 1931, at 10 (first citing Pacific Regency Arvin, DAB No. 1823, at 14, n.6 (2002); and then citing Richardson v. Perales, 402 U.S. 389, 402 (1971)); Omni Manor, DAB No. 1920, at 16-18; 42 C.F.R. § 498.61. Moreover, the Board has made clear that “[h]earsay statements may constitute substantial evidence of noncompliance if they have sufficient indicia of reliability.” Florence Park at 10 (first citing Pacific Regency, DAB No. 1823, at 14, n.6; and then citing Richardson, 402 U.S. at 402). The ALJ did not assess and explain whether W.N.’s testimony, even if it contained or relied on hearsay, nevertheless presented indicia of reliability. In response to Dr. Lee’s blanket objection to “incompetent, hearsay and conclusory statements of CMS employees, contractors and records,” the ALJ previously had stated that he intended to address the

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reliability of hearsay evidence in the written decision. P. Br. at 3; Notice of Hearing at 2. The ALJ Decision did not address the issue, however, particularly concerning W.N.’s testimony.

W.N.’s testimony was not properly subject to exclusion, or rejection as unreliable, as containing hearsay or as based upon hearsay. The factors that may be considered to evaluate the reliability of hearsay statements include whether: (1) the hearsay declarant is biased and has an interest in the result of the case; (2) the opposing party has the means to obtain the information contained in the statement and to verify its accuracy; (3) the opposing party can subpoena the declarant; (4) the statement is corroborated or contradicted by other evidence; (5) the statement is consistent with other statements made by the declarant; (6) the statement is signed or sworn to; and (7) the declarant is available to testify. Florence Park at 10 (first citing Richardson, 402 U.S. at 402-06; and then citing Pacific Regency, DAB No. 1823).

In our view, W.N.’s testimony²³ bore indicia of reliability and we disagree with the ALJ’s rejection of it wholesale in the absence of claim records like those in CMS exhibits 9-11 for 17 of the 20 beneficiaries. Of note, W.N. attested that she, as Lead Investigator in Qlarant’s Program Integrity Unit, had access to CMS’s durable medical equipment claims data that include information on the claims submitted for Medicare payment, the billing entities, and patients and ordering physicians; that W.N. herself saw the data showing Dr. Lee as “the referring/ordering provider” for four entities, including Nationwide Medical, LLC and Heart Homecare, LLC; and that the four billing entities claimed, in January and February 2018, reimbursement for DMEPOS Dr. Lee ordered for the 20 beneficiaries. CMS Ex. 8, ¶¶ 4-6. W.N. thus personally reviewed claims information that CMS keeps in the ordinary course of business and had personal knowledge of the matters about which she testified, which clearly were germane to the question of whether Qlarant (and by extension CMS) correctly identified Dr. Lee as the ordering physician. There is no assertion or evidence that W.N. is biased or has a personal interest in the outcome of the case.

Furthermore, W.N.’s testimony does not stand alone; CMS came forward with additional evidence that lends reliability to W.N.’s testimony. W.N. testified that CMS claim records identified Dr. Lee as the ordering physician for four entities who submitted, in early 2018, reimbursement claims for the DMEPOS for the 20 beneficiaries identified in Qlarant’s beneficiary list. CMS Ex. 8, ¶¶ 5, 6. L.O.’s testimony linking the three sets of claim records (CMS Exs. 9-11) to three of the beneficiaries identified in Qlarant’s list is

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consistent with, and does not detract from, W.N.’s earlier testimony that Dr. Lee was the ordering physician for the beneficiaries Qlarant identified (CMS Ex. 12, at ¶¶ 5-10), thus tending to corroborate W.N.’s testimony. Put differently, CMS’s production of claim records concerning three of the 20 beneficiaries does not, in our view, weaken or diminish the probative value of W.N.’s testimony. On the contrary, the claim records, together with L.O.’s testimony, reinforce CMS’s earlier position that Dr. Lee was the ordering physician with respect to all 20 beneficiaries. In addition, D.T.’s July 30, 2020 letter to Qlarant on Dr. Lee’s behalf, too, is consistent with both testimony and claim records CMS produced. In his letter, D.T. (writing for Dr. Lee) notified Qlarant that Dr. Lee provided services to four telemedicine companies (CMS Ex. 6, at 1), which Dr. Lee did not later disavow. Later, W.N. testified that CMS’s data showed that Dr. Lee was “the referring/ordering provider” for four entities, including, specifically, Nationwide Medical, LLC and Heart Homecare, LLC. CMS Ex. 8, at ¶ 5. The claim documents CMS later produced (CMS Exs. 9-11) were received from Qlarant, which received them from Nationwide Medical, LLC and Heart Homecare, LLC – two of the four entities W.N. identified by name earlier. In short, CMS put forth evidence that, taken together and properly viewed as a whole, consistently pointed to Dr. Lee as the ordering physician.

In accordance with the burden of proof framework outlined earlier, Dr. Lee bore the ultimate burden to show that he was not in fact the ordering physician, but never disproved or rebutted CMS’s showing that he was the ordering physician. Notably, Dr. Lee never unequivocally testified that he did not in fact treat or consult with, or order anything for, any of the beneficiaries identified on Qlarant’s list. At no time did he ever even attempt to rebut CMS’s evidence with a showing that he was not or could not have been the ordering physician with respect to any of the beneficiaries.

Rather than rebutting CMS’s prima facie case showing that he was the ordering physician, Dr. Lee chose instead to stand firm in his denial that neither he, nor anyone acting for him, ever admitted that he ordered DMEPOS for any identified beneficiary. The sum and substance of his and D.T.’s written testimony, D.T.’s hearing testimony, and D.T.’s July 30, 2020 letter to Qlarant on the factual dispute as to whether Dr. Lee was the ordering physician are that Dr. Lee never affirmatively acknowledged or admitted that the beneficiaries identified in Qlarant’s list were his patients for whom he ordered any DMEPOS later claimed for Medicare payment. There is a subtle but important distinction between such equivocal statements and, by contrast, unequivocal testimony (which Dr. Lee did not present) such as, “Mr. X was not my patient” or “I never ordered DMEPOS for my patient Mr. X.” The statements of Dr. Lee and D.T., essentially, amount to a general and somewhat evasive blanket denial, not evidence that effectively rebuts CMS’s showing that Dr. Lee ordered DMEPOS. The non-federal party cannot meet its preponderance-of-the-evidence burden by mere denials; if the evidence on which the non-federal party relies is irrelevant, unreliable, or outweighed by contrary evidence, that party has not met its burden. See Mercy Home Care, DAB No. 3044, at 18 (citing

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Oxford Manor, DAB No. 2167, at 2-3 (2008)). Thus, for example, the Board has determined that CMS made its prima facie case of deficiency concerning wound care provided to a patient where the home health agency did not dispute in its brief CMS’s allegations of noncompliance or cite any record evidence that contradicted, was inconsistent with, or detracted from the record evidence on which the ALJ relied in upholding the deficiency. See id. Accordingly, we agree with the ALJ to the extent the ALJ found Dr. Lee’s testimony itself “inadequate” for rebuttal purposes. ALJ Decision at 2 (stating that Dr. Lee “failed to rebut CMS’s prima facie case” because he “only provided his testimony to meet his burden of proof,” which was “inadequate”).

Furthermore, even were we to disregard or discount the weight of W.N.’s testimony due to the absence in the record of claim records (like those in CMS Exs. 9-11) concerning 17 beneficiaries as the ALJ did, Dr. Lee’s own testimony tends to support, rather than disprove or detract from, CMS’s successful case, for several reasons.

Dr. Lee attested that he is “the custodian of records for [his] practice” and that he looked through his records but found no records responsive to Qlarant’s request. P. Ex. 2, page 1 (not paginated). Dr. Lee wrote:

CMS would have received a claim for charges from the ancillary service provider. Not me. I do not physically sign the claim forms.

To the contrary, claim forms for ancillary service providers should be electronically submitted and billed by the ancillary service provider. I did not submit any bill for the patient encounter to CMS and I did not send the claim form. I have never seen any of the alleged claim forms. Hence, I never told CMS that these are my patients. CMS got that idea from someone else.

Because the claim forms are electronically [submitted], and presuming good faith, it is, in my professional opinion, likely that human error would easily explain this problem. Perhaps the NPI number of the referring physician was simply an error.

Id.; see also CMS Ex. 6 (D.T.’s letter to Qlarant), at 1 (explaining that Dr. Lee saw patients in the telemedicine context).

As an initial matter, Dr. Lee’s surmising that “[p]erhaps the NPI number of the referring physician was simply an error” (P. Ex. 2, page 1) is not only unfounded conjecture, it is all but an admission that Qlarant correctly referred to his NPI. Dr. Lee would have no reason to say as much were the NPI to which Qlarant referred not his NPI. (We note that Dr. Lee’s NPI, as shown in Qlarant’s beneficiary list, matches Dr. Lee’s NPI referred to in the claim records. Compare, e.g., CMS Ex. 4, at 4, with CMS Ex. 9, at 4.).

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Additionally, Dr. Lee’s positing that CMS/Qlarant’s records linking him as the ordering physician to the identified beneficiaries was “likely” the result of “human error” likewise amounts to unfounded speculation, not credible and persuasive rebuttal evidence. All the documentary and testimonial evidence CMS presented pointed to Dr. Lee as the ordering physician and, with respect to the written orders and claim-related information CMS itself produced (CMS Exs. 9-11), confirmed that Dr. Lee was in fact the ordering physician as to three beneficiaries. Notably, CMS exhibits 9, 10, and 11 include evidence of DMEPOS orders bearing Dr. Lee’s electronic signature, the entry of which required Dr. Lee’s “attestation” and the use of a unique system password. See, e.g., CMS Ex. 11, at 7. There is no record evidence showing or suggesting that Dr. Lee was not in fact the ordering physician. In short, positing as a general matter that electronic records could be less than accurate owing to “human error” does nothing to rebut CMS’s showing that Dr. Lee was the ordering physician; it merely raises the possibility that electronic records might not be 100-percent accurate every single time.

Furthermore, accepting that Dr. Lee, as the custodian of records, looked for but found no records responsive to Qlarant’s request, that does not aid Dr. Lee in his attempt to disclaim any connection to the beneficiaries identified in Qlarant’s list. The fact that Dr. Lee’s search turned up no responsive records does not rebut CMS’s successful case, as it still leaves open the possibility that he ordered DMEPOS for the beneficiaries but did not maintain relevant records. To the extent Dr. Lee’s testimony that he found no responsive records could be viewed as implying that, had Dr. Lee provided services to any of the 20 beneficiaries and ordered DMEPOS for them, he would have records concerning those services and orders, we could not simply infer that an unproductive search meant that Dr. Lee did not consult with, or order DMEPOS for, the beneficiaries. That is so because Dr. Lee himself testified that his practice would not have generated claim records responsive to the request since he saw patients in a telemedicine context. If anything, Dr. Lee’s own testimony that “ancillary service provider[s,]” not he, would have “electronically submitted and billed” for the claims (P. Ex. 2, page 1) is consistent with CMS’s evidence, including W.N.’s testimony, that Dr. Lee ordered DMEPOS for beneficiaries through several entities, to include Nationwide Medical, LLC and Heart Homecare, LLC. Likewise, Dr. Lee’s testimony that he did not “physically sign the claim forms” (id.) is consistent with CMS’s evidence that includes orders bearing Dr. Lee’s electronic signature.

Because, as explained, CMS made its prima facie case based on the evidence it proffered to the ALJ, including the claim records in CMS exhibits 9-11, and Dr. Lee did not then carry his burden, we need not entertain Dr. Lee’s suggestion that CMS could have called, but failed to call, any beneficiary to testify that Dr. Lee ordered DMEPOS for the beneficiary. If, by that suggestion, Dr. Lee is implying that the ALJ erred in not requiring CMS to produce beneficiary testimony that Dr. Lee ordered DMEPOS for the beneficiary, Dr. Lee cites no authority for that implication and fails to explain why he

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believes the ALJ erred. In any case, the argument disregards that requiring CMS to present testimony from any individuals who allegedly were Dr. Lee’s patients but who are not parties to this dispute would impose an obvious and unjustified burden on them and raises concerns about the protection of their medical privacy.

In summary, CMS has made its prima facie case on the factual issue of whether Dr. Lee ordered DMEPOS. This case does not present a situation in which the federal party (CMS), which has the burden of coming forward with evidence sufficient to establish a prima facie case, does not in fact make such a case, such that the federal party “would lose even if the [non-federal party] presents no evidence.” Hillman Rehab. Ctr., DAB No. 1611, at 23 (1997), aff’d, No. 98-3789 (GEB) (D. N.J. May 13, 1999). It is Dr. Lee who failed to carry his burden on this issue.

C. Lee did not comply with the document maintenance and access requirements in 42 C.F.R. § 424.516(f)(2).

Before the ALJ, Dr. Lee presented no evidence that he himself maintained the records concerning any of the 20 beneficiaries. ALJ Decision at 10 (“[I]t is undisputed that Petitioner did not maintain records for the 20 beneficiaries. . . .”), 15. The ALJ moreover noted that “the record is clear that Petitioner did not provide any records to [Qlarant] in response to the requests.” Id. at 10; id. at 7 (“Petitioner did not respond to [Qlarant’s] January 27, 2020 letter.”), 8 (“Petitioner did not possess the requested documents”; “Petitioner did not maintain records for those beneficiaries and did not provide those records to the UPIC upon request.”) (ALJ’s bolding and italics removed). The ALJ also stated:

Although Petitioner did not directly argue that the documentation the UPIC requested was maintained by the telehealth companies with which Petitioner contracted, Petitioner attempted to obtain the documents from those companies. CMS Ex. 6. I note that, had the telehealth companies provided the documentation to Petitioner for the three relevant beneficiaries in this case, Petitioner would still have failed to maintain the documentation himself in violation of the regulations. George M. Young, M.D., DAB No. 2750 at 10-11 (2016).

Id. at 15; see Woody, DAB No. 3102, at 15 (stating that practitioners, to include a nurse practitioner like petitioner who saw patients through a telemedicine platform, must “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”); Chintapalli, DAB No. 3122, at 13 (quoting Woody at 15) (upholding the revocation of a physician who saw patients through two telemedicine companies).

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Dr. Lee does not dispute the above statements by the ALJ. He states, without elaboration, that he “disagrees with CMS’ position that any suspension is warranted” (P. Br. to Board at 1) but does not otherwise dispute CMS’s position before the Board that Dr. Lee did not comply with section 424.516(f)(2)’s document maintenance and access requirements. CMS Br. to Board at 24. We therefore summarily affirm the ALJ’s finding that Dr. Lee did not maintain or provide access to relevant documents in compliance with section 424.516(f)(2), thus establishing a basis for revocation under section 424.535(a)(10)(i). Cf. Centro Radiologico Rolon, Inc., DAB No. 2579, at 7 (2014) (summarily affirming an unchallenged ALJ conclusion that the regulatory elements for revocation were met), appeal dismissed with prejudice, No. 3:14-cv-01611 (PG) (D.P.R. Mar. 31, 2017).

The issue we (and the ALJ) must decide is whether CMS lawfully revoked Dr. Lee’s billing privileges. If, as here, CMS determines that there is a basis to revoke billing privileges and then proceeds to revoke them, on appeal of that action, we (and the ALJ) must uphold that action if it is grounded in law and fact, as it is here. See, e.g., Cornelius M. Donohue, DPM, DAB No. 2888, at 10 (2018); Acute Care Homenursing Servs., Inc., DAB No. 2837, at 9 (2017); Lilia Gorovits, M.D., P.C., DAB No. 2985, at 10 (2020) (citing Donohue at 4), aff’d, No. 2:20-cv-01850, 2021 WL 1962903 (E.D. Pa. May 17, 2021); Young at 11.

III. Dr. Lee had no right to review of, and the ALJ erred in reaching the issue of, the 10-year re-enrollment bar; we reinstate the 10-year re-enrollment bar CMS lawfully imposed.

We restore CMS’s originally imposed 10-year re-enrollment bar, as we must, because the length of the re-enrollment bar was not properly before the ALJ. We first review the regulatory history, then discuss applicable Board precedent, to explain our determination.

In 2019, CMS revised section 424.535(c) to expand the maximum three-year re-enrollment bar then in effect to a maximum of 10 years in most cases and up to 20 years in certain cases. Section 424.535(c), as revised and in effect in 2020 when CMS revoked Dr. Lee’s billing privileges, reads as follows:

(c) Reapplying after revocation.

(1) After a provider or supplier has had their enrollment revoked, they are barred from participating in the Medicare program from the effective date of the revocation until the end of the reenrollment bar. The reenrollment bar—

(i) Begins 30 days after CMS or its contractor mails notice of the revocation and lasts a minimum of 1 year, but not greater than 10 years (except for

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the situations described in paragraphs (c)(2) and (3) of this section), depending on the severity of the basis for revocation.

(ii) Does not apply in the event a revocation of Medicare enrollment is imposed under paragraph (a)(1) of this section based upon a provider’s or supplier’s failure to respond timely to a revalidation request or other request for information.

(2)

(i) CMS may add up to 3 more years to the provider’s or supplier’s reenrollment bar (even if such period exceeds the 10-year period identified in paragraph (c)(1) of this section) if it determines that the provider or supplier is attempting to circumvent its existing reenrollment bar by enrolling in Medicare under a different name, numerical identifier or business identity.

(ii) A provider’s or supplier’s appeal rights regarding paragraph (c)(2)(i) of this section—

(A) Are governed by part 498 of this chapter; and

(B) Do not extend to the imposition of the original reenrollment bar under paragraph (c)(1) of this section; and

(C) Are limited to any additional years imposed under paragraph (c)(2)(i) of this section.

(3) CMS may impose a reenrollment bar of up to 20 years on a provider or supplier if the provider or supplier is being revoked from Medicare for the second time. In determining the length of the reenrollment bar under this paragraph (c)(3), CMS considers the following factors:

(i) The reasons for the revocations.

(ii) The length of time between the revocations.

(iii) Whether the provider or supplier has any history of final adverse actions (other than Medicare revocations) or Medicare or Medicaid payment suspensions.

(iv) Any other information that CMS deems relevant to its determination.

(4) A reenrollment bar applies to a provider or supplier under any of its current, former or future names, numerical identifiers or business identities.

42 C.F.R. § 424.535(c) (emphasis added); Final Rule, 84 Fed. Reg. 47,794, 47,854-56 (Sept. 10, 2019) (effective Nov. 4, 2019).

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In the same 2019 rulemaking, CMS made conforming changes to 42 C.F.R. § 498.3(b)(17) to state that the following are reviewable “initial determinations”:

(i) Whether to deny or revoke a provider’s or supplier’s Medicare enrollment in accordance with § 424.530 or § 424.535 of this chapter;

(ii) Whether, under § 424.535(c)(2)(i) of this chapter, to add years to a provider’s or supplier’s existing reenrollment bar; or

(iii) Whether, under § 424.535(c)(3) of this chapter, an individual or entity other than the provider or supplier that is the subject of the second revocation was the actual subject of the first revocation.

42 C.F.R. § 498.3(b)(17) (emphasis added); Final Rule, 84 Fed. Reg. at 47,857.²⁴

Under the above regulations, where a re-enrollment bar must be imposed, in general, the bar lasts from one year to 10 years, depending on the severity of the revocation basis, and that bar is not reviewable. The only exceptions are inapplicable to this case. The duration of the re-enrollment bar may be appealed if CMS added, under section 424.535(c)(2)(i), three or more years to the re-enrollment bar imposed under section 424.535(c)(1)(i) because CMS determined the provider or supplier attempted to circumvent an existing re-enrollment bar by enrolling under a different name, numerical identifier, or business identity. In that circumstance, only the duration of the “additional years” of the re-enrollment bar imposed under section 424.535(c)(2)(i) is reviewable; the

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“original” re-enrollment bar imposed under section 424.535(c)(1)(i) (which could be 10 years, as here) is not reviewable.²⁵

The ALJ wrote:

[The CMS contractor] imposed a ten-year reenrollment bar on Petitioner. CMS Ex. 2 at 3. Petitioner argues that the maximum ten-year reenrollment bar is not warranted because Petitioner only failed in one act and not multiple acts. P. Br. at 1. Presumably, Petitioner’s argument is meant to convey that the law would only permit a one-year reenrollment bar.

CMS’s position is that Petitioner failed to provide documents related to requests for 20 Medicare beneficiaries; therefore, there were 20 acts of non-compliance. Given that each act can result in a one-year reenrollment bar, CMS urges that it was justified in imposing a ten-year reenrollment bar. CMS Br. at 14-15.

The regulations provide that CMS may impose a reenrollment bar that is between one and ten years in length. 42 C.F.R. § 424.535(c)(1)(i). CMS’s discretionary decision as to the length of the reenrollment bar is not subject to review. Vijendra Dave, M.D., DAB No. 2672 at 11 (2016). However, a revocation under 42 C.F.R. § 424.535(a)(10) contains a limitation as to the length of the reenrollment bar . . . .

I agree with CMS’s reading of the statute and regulation. The UPIC requested documents from Petitioner for 20 separate beneficiaries based on 20 separate claims that Medicare had received. Petitioner’s failure to maintain and produce records for the UPIC was a separate act of noncompliance for each beneficiary. In this case I find that Petitioner only failed to maintain and produce documents related to three Written Orders associated with three beneficiaries. Because that is only three acts of

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noncompliance, CMS may, as a matter of law, bar Petitioner from reenrollment for a maximum term of three years from September 17, 2020. See CMS Ex. 2 at 3.

ALJ Decision at 15-16.

The ALJ thus correctly considered section 424.535(c)(1)(i) in effect on the date of revocation, which authorized CMS to impose a 10-year re-enrollment bar. And, citing a 2016 Board decision (Dave) issued before the 2019 regulatory changes, the ALJ also correctly noted that the Board has determined CMS’s discretionary decision as to the length of the re-enrollment bar is not subject to review. Nevertheless, the ALJ concluded that CMS may impose at most a three-year re-enrollment bar in this case, per section 424.535(a)(10)(ii), because the evidence (DMEPOS orders for three of the 20 beneficiaries) supported only three acts of noncompliance with section 424.516(f)(2). See ALJ Decision at 2, 15, 16.

The ALJ’s analysis of the re-enrollment bar is erroneous because, foremost, Dr. Lee had no right to appeal under Part 498 the 10-year re-enrollment bar. There is no assertion, or evidence, that the August 18, 2020 revocation Dr. Lee appealed was a second revocation, or that in 2020 CMS imposed an augmented re-enrollment bar based on a determination that Dr. Lee improperly sought to circumvent an existing re-enrollment bar or to bill Medicare using a different name, identifier, or identity. In short, there is nothing in the record that causes us to question whether the 2020 revocation (and the imposition of a 10-year bar) was based on a regulation other than section 424.535(c)(1)(i) that took effect in late 2019. Accordingly, no appeal rights attached to the 10-year re-enrollment bar, and the ALJ had no authority to review that issue. This conclusion effectively renders null the ALJ’s conclusion that CMS could lawfully impose only a three-year re-enrollment bar.

In Vijendra Dave, M.D., DAB No. 2672 (2016), the Board first took a definitive position on the question of whether the re-enrollment bar in accordance with the regulations then in effect (providing for a maximum three-year bar) was subject to review under Part 498 regulations. The Board concluded that its review authority under Part 498 did “not extend to reviewing the length of the reenrollment bar imposed by CMS.” Dave at 9. There, the Board noted that among the “initial determinations” subject to Part 498 review and as listed in 42 C.F.R. § 498.3(b) is “[w]hether to . . . revoke a . . . provider’s or supplier’s Medicare enrollment in accordance with . . . [42 C.F.R.] § 424.535.” Id. at 10 (emphasis in original) (quoting 42 C.F.R. § 498.3(b)(17)). “Hence, a determination to revoke a supplier’s enrollment under section 424.535(a) may be appealed by a supplier in accordance with Part 498’s procedures”; however, the Board noted, nowhere in section 498.3(b)’s list of appealable initial determinations was there a determination on the “duration of a post-revocation re-enrollment bar.” Id.

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Since 2016, the Board has consistently reiterated that the length of the re-enrollment bar is not reviewable under Part 498. See, e.g., Blossomwood Medical, P.C., et al., DAB No. 2914, at 11 (2018), aff’d, No. 5:19-CV-00232, 2020 WL 5632970 (N.D. Ala. Sept. 21, 2020); Sheetal Kumar, M.D., P.A., DAB No. 2965, at 11-12 (2019); Linda Silva, P.A., DAB No. 2966, at 11 (2019); Gorovits, DAB No. 2985, at 15-16; Blair Allen Nelson, M.D., DAB No. 3024, at 13 (2020); John O. Dimowo, M.D., DAB No. 3101, at 12-13 (2023); Woody, DAB No. 3102, at 19-21; Syed M. Aziz, M.D., DAB No. 3124, at 11 (2023). We reaffirm here, consistent with Dave, that the re-enrollment bar is not reviewable and, considering the 2019 regulatory changes, determine that ALJs and the Board have no authority to review CMS’s imposition of a re-enrollment bar of up to 10 years under section 424.535(c)(1)(i).

The text of 42 C.F.R. § 424.535(a)(10)(ii) does not alter the non-reviewability of the length of the re-enrollment bar, as explained in Woody, DAB No. 3102. In Woody, the revoked petitioner argued that there was only one “act of noncompliance” for purposes of section 424.535(a)(10)(ii), so the re-enrollment bar could not exceed one year and the ALJ erred by upholding a 10-year bar. Woody at 19-20. The Board rejected that argument, explaining:

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. 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. Board decisions fully support this conclusion.

Id. at 20 (citations omitted).

The ALJ’s error in reaching the re-enrollment bar aside, as noted earlier, the ALJ conflated a factual issue relevant to determining, initially, whether the supplier complied with section 424.516(f)(2) in the first place and the duration of the re-enrollment bar period. As the Board stated in Dave, “[a]lthough the re-enrollment bar is a direct and legally mandated consequence of an appealable revocation determination,” a re-enrollment bar’s duration is “factually distinct” from revocation itself and is “governed by different legal requirements,” that is, section 424.535(c). Dave at 10 (citing North

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Ridge Care Ctr., DAB No. 1857, at 8 (2002)) (stating that “[g]iven section 498.3(b)’s precise and exclusive enumeration of appealable determinations, we cannot find a CMS action to be appealable under Part 498 unless section 498.3(b) describes the subject matter of that action”); see also id. at 11 (stating that “[t]he determinations specified in section 498.3(b) do not, under any reasonable interpretation of that regulation’s text, include CMS decisions” concerning the duration of the re-enrollment bar); Final Rule, 73 Fed. Reg. 36,448, 36,454 (June 27, 2008) (“[W]hile we believe that providers and suppliers can appeal the revocation determination, we do not believe that providers and suppliers can appeal the duration of the re-enrollment bar for Medicare billing privilege.”) (preamble discussed in Dave at 11). The Board’s rationale in 2016 in Dave remains as valid now, if not more so, in light of the 2019 revisions to section 424.535(c) and the preamble language associated with those revisions.

CMS urges the Board to consider, in the alternative, that noncompliance with section 424.516(f)(2) could establish two separate acts – first, failure to maintain documents for seven years; and second, failure to provide access to those documents on request. According to CMS, Dr. Lee could be found to have committed six separate acts of noncompliance, that is, two acts of noncompliance for each of the three beneficiaries for whom the ALJ determined Dr. Lee had ordered DMEPOS. See CMS Br. to Board at 1-2, 22, 24-25.

CMS’s argument is not properly before us, for several reasons. As an initial matter, this argument appears to be different from CMS’s position on reconsideration, which was that the failure to maintain documents and the failure to provide access to documents (for each beneficiary), together, constitute one act of noncompliance. In any event, as discussed above, the Board, like the ALJ, has no authority to review the 10-year re-enrollment bar lawfully imposed on Dr. Lee in accordance with section 424.535(c)(1)(i), so we could not adjust the re-enrollment bar to a duration between the three years and 10 years even if we found CMS’s argument persuasive. Furthermore, even if we had authority to address CMS’s argument for a six-year re-enrollment bar, we need not do so here given our resolution on the regulatory basis for revocation.

Additionally, assuming that CMS’s argument for a six-year re-enrollment bar were properly before us (which it is not), we would not necessarily accept CMS’s reasoning. CMS appears to rely on the following language in Young:

By its plain language, section 424.516(f)(2) requires a physician, like [Dr. Young], who orders DMEPOS items billed to Medicare, to do two things. First, he or she must maintain documents, written and electronic, related to written orders or certifications or requests for payments for DMEPOS items for a period of seven years. Second, he or she must provide CMS or its contractor access to those documents upon request.

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See CMS Br. to Board at 23 (quoting Young, DAB No. 2750, at 8). However, the Board did not determine in Young that the failure to maintain and provide access to records could constitute two separate acts of noncompliance for purposes of establishing a re-enrollment bar under 424.535(a)(10)(ii). Instead, the Board merely restated in simple terms the two interrelated actions that section 424.516(f)(2) requires. Notably, Young presented no argument about, and thus no need to consider, what constitutes an act of noncompliance because CMS imposed on Dr. Young only the minimum one-year re-enrollment bar (of the maximum three years authorized under the regulations then in effect) once it determined to revoke his enrollment. See Young at 2, 4.

Finally, we repeat that, to date, the Board has not reached the specific issue of what constitutes an act of noncompliance for purposes of section 1842(h)(9) of the Act or section 424.516(f)(2), for purposes of revocation under section 424.535(a)(10)(i), where neither the statute nor the governing regulations define the meaning of the term “act of noncompliance” for such purposes. We need not reach the issue to resolve this case and express no opinion here on the ALJ’s apparent acceptance of CMS’s position that the failure to provide access to documents concerning 20 beneficiaries could constitute 20 acts of noncompliance. See ALJ Decision at 15-16 (discussing CMS’s position and stating that the ALJ “agree[d] with CMS’s reading of the statute and regulation”). Were we presented with a case in which we would need to reach the issue, we would anticipate needing both parties to address the issue in their briefs, which neither CMS nor Dr. Lee has done in this case.

Conclusion

We affirm the ALJ’s conclusion that CMS lawfully revoked Dr. Lee’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(10)(i). We vacate and void that part of the ALJ Decision in which the ALJ reviewed the 10-year re-enrollment bar and determined that CMS may impose at most a three-year re-enrollment bar, thereby leaving in place CMS’s imposition of a 10-year re-enrollment bar.

Endnotes

¹ Frank B. Lee, M.D. was “Petitioner” who appealed the revocation to the ALJ. We will refer to Frank B. Lee, M.D. as either “Dr. Lee” or “Petitioner,” as appropriate.

² DMEPOS subject to Medicare Part B coverage include prosthetics that replace all or part of an internal body organ, as well as orthotic items like leg and back braces. See Social Security Act (Act) § 1861(n), (s)(6), (s)(8), (s)(9); Medicare Claim Processing Manual (MCPM), CMS Pub. 100-04, Ch. 20, §§ 10.1.1-10.1.3. (The MCPM is available at: https://www.cms.gov/regulations-and-guidance/guidance/manuals/internet-only-manuals-ioms-items/cms018912). For Medicare to cover and pay for such items, the items must, among other requirements, be “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” Act § 1862(a)(1)(A).

³ The term “supplier” means, “unless the context otherwise requires, a physician or other practitioner, a facility, or other entity (other than a ‘provider of services’ [as defined in Act § 1861(u)]) that furnishes items or services” under the Medicare program. Act § 1861(d); see also 42 C.F.R. § 400.202 (defining “supplier” similarly). “Providers,” for purposes of Medicare, include hospitals, skilled nursing facilities, and home health agencies. 42 C.F.R. § 400.202.

⁴ We apply the enrollment regulations in effect on the date of the initial determination to revoke billing privileges. See John P. McDonough III, Ph.D., DAB No. 2728, at 2, n.1 (2016). In the “Legal Background” section, we quote the operative regulations, notably 42 C.F.R. §§ 424.535(a)(10), 424.516(f)(2), and 424.535(c)(1), that were in effect on August 18, 2020, the date of the initial determination to revoke Dr. Lee’s enrollment and billing privileges.

⁵ Providers and suppliers that “furnish[ ] covered ordered, certified, referred, or prescribed Part A or B services, items or drugs” likewise must maintain for seven years and provide access to such documents. See 42 C.F.R. § 424.516(f)(1). “Thus, a DMEPOS supplier entity [that furnished DMEPOS], too, could be subject to the records maintenance and access requirements.” Uma Chintapalli, MD, DAB No. 3122, at 13 n.18 (2023); see also Final Rule, 77 Fed. Reg. 25,284, 25,310 (April 27, 2012) (stating that section 424.516(f) “places the responsibility for the maintenance of records on both the ordering and certifying physician and the provider and supplier,” and that “[t]he physician or other eligible professional who signed the order or certification is responsible for maintaining and disclosing the documentation”).

⁶ The National Provider Identifier, or “NPI,” is “the standard unique health identifier for health care providers (including Medicare suppliers).” Medicare Program Integrity Manual (MPIM), CMS Pub. 100-08, Ch. 10, § 10.1.1. The MPIM is available at: https://www.cms.gov/regulations-and-guidance/guidance/manuals/internet-only-manuals-ioms-items/cms019033.

⁷ The regulations in 42 C.F.R. § 424.535(c) in effect from February 3, 2015 through November 3, 2019 authorized CMS to impose a re-enrollment bar of one year to three years. See 79 Fed. Reg. 72,500, 72,532 (Dec. 5, 2014). Effective November 4, 2019, the regulations were revised to authorize CMS to impose a re-enrollment bar up to 10 years in most cases, but up to 20 years under certain circumstances not shown to be applicable to Dr. Lee’s case. See 84 Fed. Reg. 47,794, 47,854-56 (Sept. 10, 2019). We will discuss the re-enrollment bar regulations that govern this case in more detail in our analysis.

⁸ UPICs are CMS contractors “responsible for preventing, detecting, and deterring fraud, waste, and abuse in both the Medicare program and the Medicaid program.” MPIM, Ch. 4, § 4.2.2.1.

⁹ A Medicare Administrative Contractor performs various functions related to the enrollment of providers and suppliers in Medicare, as well as certain functions related to maintaining integrity in the program. See MPIM, Ch. 1, §§ 1.1, 1.3, 1.3.1 and Ch. 10, § 10.1.

¹⁰ As noted earlier, on July 30, 2020, attorney D.T. wrote a letter to Qlarant on behalf of Dr. Lee. CMS Ex. 6. However, a different attorney represented Dr. Lee on appeal before the ALJ and continues to represent him before the Board.

¹¹ Hearsay may be admitted into evidence in hearings conducted pursuant to the regulations in 42 C.F.R. Part 498, subpart D. See 42 C.F.R. § 498.61 (“Evidence may be received at the hearing even though inadmissible under the rules of evidence applicable to court procedure. The ALJ rules on the admissibility of evidence.”); Florence Park Care Ctr., DAB No. 1931, at 10 (2004) (stating that hearsay is admissible in Part 498 proceedings even if it would be inadmissible under the rules of evidence applicable to court proceedings, if they are supported by sufficient indica of reliability); Community Northview Care Ctr., DAB No. 2295, at 28 (2009) (quoting Omni Manor Nursing Home, DAB No. 1920, at 17 (2004), aff’d, 151 F. App’x 427 (6th Cir. 2005)) (stating that an ALJ may admit hearsay evidence subject to relevance and fundamental fairness, but should assess the weight to be accorded to hearsay, considering the degree of its reliability and whether it is corroborated by other evidence).

¹² The Board’s Guidelines are available at: https://www.hhs.gov/about/agencies/dab/different-appeals-at-dab/appeals-to-board/guidelines/enrollment/index.html?language=en.

¹³ The Board has authority to “modify” an ALJ’s decision in cases, such as this one, governed by the regulations in 42 C.F.R. Part 498. See 42 C.F.R. § 498.88(f)(1)(iii) (stating that “[i]f the Board does not remand the case to an ALJ,” the Board “[m]ay modify, affirm, or reverse the ALJ’s decision”); Spring Meadows Health Care Ctr., DAB No. 1966, at 15, n.6 (2005) (stating that the Board may “modify an ALJ decision, in whole or in part”).

¹⁴ “Preamble language does not have the force and effect of law as a regulation does, though we may look to preamble language as appropriate . . . to understand the meaning of a regulation and the drafters’ intent behind and rationale for promulgating a regulation.” Thomas Falls, M.D., DAB No. 3056, at 12 (2022).

¹⁵ The Board may vacate an ALJ’s decision in part for error in reaching and deciding an issue not properly before the ALJ. SeeBorgess Med. Ctr., DAB No. 3106, at 1-2 (2023) (vacating for error that part of the ALJ’s decision discussing issues of when and whether the provider met certain regulatory requirements that were not before the ALJ); Farzana Naqvi, M.D. and Syed Naqvi, M.D., DAB No. 3016, at 1, 7-8 (2020) (vacating that part of the ALJ’s decision granting physician-suppliers a 30-day retrospective billing period where that issue was not properly before the ALJ).

¹⁶ In an older case, however, CMS asked for the records of 14 beneficiaries. SeeYoung, DAB No. 2750, at 3. We do not know why there CMS did not request the records of a round number of beneficiaries, such as 20. One possible reason is that CMS’s or its contractor’s records revealed that Dr. Young’s name was associated with only the 14 beneficiaries and the dates of service associated with those beneficiaries fell within the prescribed document maintenance period.

¹⁷ The contractor apparently intended to ask Dr. Chintapalli for the records concerning 20 beneficiaries but inadvertently included one beneficiary, for the same date of service, twice in its beneficiary list, thus requesting the records concerning 19 beneficiaries. See Chintapalli, DAB No. 3122, at 4, n.7.

¹⁸ Dr. Sasser appealed the ALJ’s decision, DAB CR6190, to the Board (Appellate Division docket number A-23-24), but the Board did not reach a decision on appeal because Dr. Sasser and CMS resolved their dispute during the pendency of Dr. Sasser’s appeal to the Board.

¹⁹ Neither the Act nor the regulations in 42 C.F.R. Part 424, subpart P, which govern enrollment, define the meaning of the term “act of noncompliance” in section 1842(h)(9) of the Act and in section 424.535(a)(10)(ii). CMS acknowledges that the Act does not define what “act of noncompliance” means for purposes of section 1842(h)(9). CMS Br. to Board at 22-23. In Woody, the Board construed CMS’s reference to the phrase “individual act of noncompliance” as a reference to section 424.535(a)(10)(ii)’s language (“is subject to revocation for a period of not more than 1 year for each act of noncompliance”). See Woody, DAB No. 3102, at 6, n.11. To date, the Board has not determined whether CMS’s interpretation of the meaning of the term “act of noncompliance” is consistent with the law and regulations. We need not reach that issue to resolve this case, particularly since Dr. Lee does not raise any argument about that issue.

²⁰ In the few cases that the Board has decided that arose from supplier revocation under 42 C.F.R. § 424.535(a)(10)(i) for failure to comply with 42 C.F.R. § 424.516(f)(2), none presented a factual dispute about whether the revoked supplier ordered or provided referrals for the DMEPOS. SeeYoung, DAB No. 2750, at 8 (“[Dr. Young] does not dispute . . . that the beneficiaries whose names appear on CMS’s request were . . . patients for whom he . . . ordered DMEPOS. . . .”); Woody, DAB No. 3102, at 10 (noting that petitioner did not dispute she provided DMEPOS referrals for the 20 beneficiaries whose names appeared on the contractor’s record requests); Chintapalli, DAB No. 3122, at 11 (noting petitioner did not dispute that she was the ordering physician).

²¹ CMS first submitted W.N.’s declaration as CMS exhibit 8. Later, CMS produced claims records related to three of the beneficiaries on Qlarant’s list as CMS exhibits 9-11, along with L.O.’s declaration (CMS Ex. 12), with its response opposing Dr. Lee’s cross-motion for summary judgment in his favor, to reinforce CMS’s position that Dr. Lee was in fact the ordering physician.

²² In the 2016 preamble to the Proposed Rule revising section 424.516(f), CMS stated:

We believe it is important that our expansion of § 424.516(f) include all Part A and B services, items, and drugs be consistent with our proposed revisions to § 424.507 [concerning conditions for payment of claims for ordered, certified, referred, or prescribed covered Part A or B services, items or drugs]. Both provisions are intended to help make certain that payments for Part A and B services, items, and drugs are made correctly. To require all persons who order, certify, refer, and prescribe Part A and B services, items or drugs to enroll in Medicare without requiring them (or the billing provider) to retain supporting documentation would undercut the effectiveness of § 424.507. Without being able to review this documentation, we may lack the ability to confirm that the order, certification, referral or prescription was proper and that the ordering, certifying, referring or prescribing individual was qualified.

See 81 Fed. Reg. at 10,737. The final rule was published on September 10, 2019, at 84 Fed. Reg. 47,794.

²³ Witnesses must testify “under oath or affirmation.” 42 C.F.R. § 498.62; see also ALJ’s Standing Order ¶ 11 (citing 28 U.S.C. § 1746) (stating that “[w]itness testimony must be submitted in the form of an affidavit made under oath or as a written declaration that the witness signs under penalty of perjury for false testimony”); Civil Remedies Division Procedures ¶ 19.b. W.N. stated, “I declare under penalty of perjury that the foregoing is true and correct to the best of my knowledge.” CMS Ex. 8, at 2. Dr. Lee never questioned the form of W.N.’s oath or W.N.’s ability to testify truthfully.

²⁴ In the preamble to the Proposed Rule, CMS wrote:

[An] affected provider or supplier could appeal CMS’ imposition of additional years to the provider’s or supplier’s existing reenrollment bar under § 424.535(c)(2). These appeals rights would be governed by 42 CFR part 498. However, they would not extend to the imposition of the original enrollment bar under § 424.535(c)(1); they would be limited to the additional years imposed under § 424.535(c)(2). . . . [W]e proposed in new § 424.535 paragraph (c)(3) that CMS may impose a reenrollment bar of up to 20 years if the provider or supplier is being revoked from Medicare for the second time. Multiple revocations indicate that the provider or supplier cannot be considered a reliable partner of the Medicare program. The reenrollment bar under paragraph (c)(3) would be in lieu of the reenrollment bar described in paragraph (c)(1). We would determine the bar’s length by considering the following factors . . . . We could apply paragraph (c)(3) even if the two revocations occurred under different names, numerical identifiers or business identities so long as we can determine that the two actions effectively involved the same provider or supplier.

81 Fed. Reg. at 10,732. Similarly, in the preamble to the Final Rule, CMS stated:

We noted [in the Proposed Rule] that the affected provider or supplier could appeal CMS’ imposition of additional years to the provider’s or supplier’s existing reenrollment bar under § 424.535(c)(2). These appeal rights would be governed by 42 CFR part 498. However, they would not extend to the imposition of the original reenrollment bar under § 424.535(c)(1); they would be limited to the additional years imposed under § 424.535(c)(2).

84 Fed. Reg. at 47,826.

²⁵ In the preamble to the Final Rule, CMS also discussed the reviewability of the re-enrollment bar in “mistaken identity” situations where the revoked provider or supplier asserts and could prove that the provider or supplier was not in fact the subject of the first or original revocation. CMS wrote:

With respect to the maximum 20-year bar for individuals or entities that have been revoked a second time, CMS believes that the standard appeals process at Part 498 should allow for the resolution of ‘‘mistaken identity’’ cases regarding the first revocation. In other words, if a provider or supplier to which CMS applies § 424.535(c)(3) correctly claims on appeal that a different individual or entity was, in fact, the subject of the first revocation, CMS will be able modify the reenrollment bar length such that it only applies to the second revocation, pursuant to § 424.535(c)(1). As explained below, we are modifying § 498.3(b)(17) to afford appeal rights in this scenario.

84 Fed. Reg. at 47,827.