Jaqueline Howard, MD, DAB CR5847 (2021)

DECISION

Novitas Solutions (Novitas) and Noridian Healthcare Solutions (Noridian), administrative contractors acting on behalf of the Centers for Medicare & Medicaid Services (CMS), separately revoked the Medicare enrollment and billing privileges of Petitioner, Jacqueline Howard, MD, because she failed to provide Qlarant Integrity Solutions, LLC (Qlarant), a unified program integrity contractor (UPIC), with requested documentation  for 20 Medicare beneficiaries for whom she had ordered durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS).  Thereafter, CMS upheld Petitioner's revocation.  For the reasons stated herein, I affirm the revocation of Petitioner's Medicare enrollment and billing privileges.

I.  Background

Petitioner is a physician.  See, e.g, P. Ex. J at 1.  On December 12, 2019 and July 15, 2020, Qlarant informed Petitioner that it was conducting a review of DMEPOS claims and requested that she submit records for 20 beneficiaries for whom she was the ordering physician for DMEPOS items.  CMS Exs. 4 at 1-2, 4-5; 5 at 1-2; see CMS Exs. 4 at 7; 5 at 7 (spreadsheet listing 20 Medicare beneficiaries and the dates of service).  On July 15, 2020, Qlarant cautioned that "administrative action, including revocation, may be taken" if it did not receive the requested records within 15 days.  CMS Ex. 5 at 5.

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After Petitioner did not submit the requested records within 15 days, Novitas and Noridian issued separate notices, dated August 19, 2020, informing Petitioner that her Medicare enrollment would be revoked pursuant to 42 C.F.R. § 424.535(a)(10), effective September 18, 2020, due her failure to comply with 42 C.F.R. § 424.516(f).1   CMS Exs. 2, 3.  Novitas and Noridian also informed Petitioner that a 10-year bar to re-enrollment had been imposed.  CMS Exs. 2 at 3; 3 at 2.

Petitioner submitted, via an email message sent to CMS's Provider Enrollment & Oversight Group on August 25, 2020, a request for reconsideration in which she  provided the following explanation:

I have never billed [CMS] directly for any service I have provided.  As for the patients listed, I do not know them.  And they are not my personal patients from my medical office, which is cash based.  I do not have and, I never had any medical records or any other information on them.  I worked for a telemedicine company which furnished [DMEPOS items] in 2018.  The only information I got was from the portal and what the patient revealed to me when I called them.  I keep no records on any of those patients.

CMS Ex. 1 at 1; see P. Ex. F at 3 ("Dr. Howard filed a request for reconsideration, via email . . . on or about August 26, 2020.").

On October 19, 2020, CMS issued a reconsidered determination in which it upheld Petitioner's revocation pursuant to 42 C.F.R. § 424.535(a)(10).2   P. Ex. A.  CMS explained, in pertinent part:

The documentation the supplier is required to maintain for seven years includes written and electronic documents (including the NPI of the supplier who ordered and certified DMEPOS items).  The documentation relates to written orders, certifications, referrals, prescriptions, or requests for payments for Part A or B services, items, or drugs.  Since [Petitioner] is a supplier who provides Medicare Part B services, including ordering and certifying DMEPOS items, this regulation applies to her.  [Petitioner] admits that while she worked with the telemedicine company she did not keep records on any of those patients.  This is sufficient to establish that [Petitioner] failed to comply with the documentation requirement at

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§ 424.516(f)(2)(i)(A).  According to § 424.516(f), the responsibility to maintain documentation ultimately lies with the supplier who orders, certifies, refers, or prescribes Part A or B services, items, or drugs.  The fact that [Petitioner] used the telemedicine portal, or that she did not directly bill Medicare for reimbursement does not absolve her of the obligation to maintain proper documentation as required by [§ 424.516(f)(2)(i)(A)].

P. Ex. A at 3-4.  CMS further explained that Qlarant had requested medical records for 20 beneficiaries for whom Petitioner had ordered DMEPOS items, and that Petitioner "admitted that she did not maintain the medical records . . . and did not provide any of the requested documentation within the requested timeframe."  P. Ex. A at 4.  CMS determined Petitioner "failed to comply with the requirements of [42 C.F.R.] § 424.516(f)(2)(i)(B)," which requires a physician who orders, certifies, refers, or prescribes, inter alia, DMEPOS items to provide CMS and its contractors access to such documentation.  P. Ex. A at 4.

Petitioner, through counsel, submitted a timely request for an administrative law judge (ALJ) hearing that was received on November 19, 2020.3   On November 23, 2020, the Civil Remedies Division issued my standing pre-hearing order (Pre-Hearing Order), which directed the parties to file their respective pre-hearing exchanges.  CMS filed a pre‑hearing brief and motion for summary judgment, along with five proposed exhibits (CMS Exs. 1-5).  Petitioner filed a response (P. Br.) and twelve proposed exhibits (P. Exs. A-L).4   In the absence of any objections, I admit all submitted exhibits into the evidentiary record.

Neither party has submitted the written direct testimony of any witnesses, and a hearing is therefore unnecessary for the purpose of cross-examination of any witnesses.  See Pre‑Hearing Order §§ 12-14.  I consider the record in this case to be closed, and the matter is ready for a decision on the merits.5

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II.  Issue

Whether CMS had a legitimate basis to revoke Petitioner's Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10).

III.  Jurisdiction

I have jurisdiction to decide this issue.  42 C.F.R. §§ 498.3(b)(17), 498.5(1)(2); see also 42 U.S.C. § 1395cc(j)(8).

IV.  Findings of Fact, Conclusions of Law, and Analysis6

Pursuant to 42 U.S.C. § 1395cc(j)(1)(A), CMS has promulgated enrollment regulations.  See 42 C.F.R. § 424.500 et seq.  These regulations give CMS the authority to revoke the billing privileges of an enrolled supplier under specified circumstances.  See 42 C.F.R. § 424.535(a).  Relevant to this case, CMS may revoke a supplier's billing privileges when it determines that the supplier has failed to document or provide access to certain documentation.  42 C.F.R. § 424.535(a)(10); see 42 U.S.C. § 1395u(h)(9).  The relevant revocation authority, 42 C.F.R. § 424.535(a)(10), states the following:

(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.

Section 424.516 provides additional provider and supplier requirements for enrolling and maintaining active enrollment status in the Medicare program.  Specifically, the regulation at section 424.516(f) provides:

(f) Maintaining and providing access to documentation.

* * *

(2)(i) A physician . . . 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

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(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).

The regulation further directs that documentation that must be maintained includes "written and electronic documents . . . relating to written orders, certifications, referrals, prescriptions or requests for payments for Part A or B services, items, or drugs."  42 C.F.R. § 424.516(f)(2)(ii).

At the time of the initial determination, if CMS revoked a provider's or supplier's enrollment, it could impose a bar on re‑enrollment for a minimum of one year, but no more than ten years.7   42 C.F.R. § 424.535(c)(1)(i).

1.  The UPIC asked Petitioner to provide documentation for 20 specific beneficiaries for whom she ordered DMEPOS items.

2.  Petitioner informed the UPIC that she could not produce the requested documentation because she did not maintain her own copy of those records.

3.  Because Petitioner could not comply with a request that she provide documentation relating to DMEPOS orders for Medicare beneficiaries, as required by 42 C.F.R. § 424.516(f), CMS was authorized to revoke her enrollment pursuant to 42 C.F.R. § 424.535(a)(10).

The UPIC requested that Petitioner provide copies of medical records for 20 Medicare beneficiaries for whom she had ordered DMEPOS items.  CMS Exs. 2 at 4; 3 at 4; 4 at 7; 5 at 7.  Petitioner concedes that she did not maintain and retain the requested documentation, and argues that she was not required to do so because she was not the "custodian" of these records.  P. Br. at 2; see CMS Ex. 1 at 1.  Regardless of whether another entity purports to maintain copies of beneficiary records, Petitioner, as the ordering physician and a supplier in the Medicare program, is required, pursuant to 42 C.F.R. § 424.516(f), to maintain and retain for at least seven years documentation supporting her DMEPOS orders for Medicare beneficiaries.  Because Petitioner was unable to produce the requested documentation for 20 Medicare beneficiaries upon the request of the UPIC, as required by 42 C.F.R. § 424.516(f), CMS had a legitimate basis

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to revoke her Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10).

Petitioner argues that she did not maintain and retain records because she had entered into a contractual agreement with REMN Management, LLC ("REMN") through Barton Associates that required her to access medical records through REMN's electronic platform.  P. Br. at 2.  Notwithstanding the terms of her contractual agreement with REMN, Petitioner, as a Medicare participant, was independently required to maintain and retain, for a period of seven years, documentation supporting her written orders and prescriptions for Part A and B items and services; specifically, as relevant here, Petitioner was required to maintain documentation relating to her orders for DMEPOS items.8  42 C.F.R. § 424.516(f)(2).  Petitioner's failure to maintain, retain, and provide access to records supporting the DMEPOS orders that were requested by the UPIC subjects her to revocation of her enrollment pursuant to 42 C.F.R. §§ 424.535(a)(10) and 424.516(f).  See 42 U.S.C. § 1395u(h)(9) ("The Secretary may revoke enrollment, for a period of not more than one year for each act, . . . if such physician . . . fails to maintain and . . . provide access to . . . written orders or requests for payment for durable medical equipment . . . .").  Contrary to Petitioner's understanding of Medicare participation requirements, a physician must independently maintain documentation of his or her orders for, inter alia,  DMEPOS items for Medicare beneficiaries, even when another entity separately maintains those records.  42 C.F.R. § 424.516(f)(2)  ("A physician . . . who orders . . . items . . . is required to . . . [m]aintain documentation . . . for 7 years from the date of the service; and . . . provide access to that documentation . . . .").

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To the extent Petitioner entered into a contractual agreement that specified that REMN, and not Petitioner, would maintain and retain documentation supporting her DMEPOS orders to Medicare beneficiaries, such an agreement cannot exempt Petitioner from Medicare participation requirements.  In fact, the rulemaking adding the instant basis for revocation and revising 42 C.F.R. § 424.516 specifically explained that both a physician and another entity may simultaneously be required to maintain, inter alia, records supporting DMEPOS orders, explaining that "[t]his final rule places the responsibility for the maintenance of records on both the ordering and certifying physician and the provider and supplier."  77 Fed. Reg. at 25,310 (emphasis added).9  The rulemaking unambiguously clarified that "[t]he physician or other eligible professional who signed the order or certification is responsible for maintaining and disclosing the documentation."  Id.

Petitioner highlights an excerpt from the aforementioned rulemaking that states "from time to time situations arise that are outside the control of these custodians" and that CMS will "conduct an analysis based on the specific facts and circumstances."  P. Br. at 3 (emphasis omitted), citing 77 Fed. Reg. at 25,309-10.  Notably, Petitioner omitted the context of this passage, which is a response to a comment inquiring whether "a home health agency would be considered to have forged documentation if the documentation to be required could not be produced by the physician but could be found in the home health agency's documentation."10   Id.  Unlike the circumstance here, the commenter was addressing a circumstance that would be beyond its control; Petitioner had full control over her circumstances, in that she agreed to use REMN's records platform and did not maintain her own copies of documentation.

Likewise, Petitioner block-quotes another out-of-context passage in which CMS contemplated that certain circumstances may warrant it to exercise discretion to not revoke enrollment.  P. Br. at 4, citing 77 Fed. Reg. at 25,310.  However, the comment response addressed an inquiry about a circumstance where a provider had made "good faith efforts" to maintain and retain records but the records had been lost or destroyed "due to circumstances beyond the provider's control" such as a "systems malfunction" or

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"natural disaster."11  Id.  Such a circumstance is not present here.  Petitioner knowingly chose not to maintain or retain records, despite the requirement set forth in section 424.516(f).  To the extent Petitioner challenges that CMS did not exercise discretion in her favor, the DAB has explained that "it is not for the ALJ and the [DAB] to look behind that exercise of discretion to ask whether he or she, or the Board, standing in CMS's shoes, would reach the same decision to revoke."  George M. Young, M.D., DAB No. 2750 at 11 (2016); see also Letantia Bussell, M.D., DAB No. 2196 at 13 (2008) (holding that an ALJ could not substitute her discretion for that of CMS in a Medicare enrollment determination); Decatur Health Imaging, LLC, DAB No. 2805 at 8-9 (2017) (DAB does not review CMS's exercise of discretion to take other actions that the regulations authorize relating to the enrollment of suppliers and providers).

V.  Conclusion

For the reasons explained above, I affirm the revocation of Petitioner's Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10).

1. Novitas and Noridian issued separate determinations because Petitioner had been enrolled in more than one jurisdiction.  See CMS Exs. 2, 3.
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2. I cite to the copy of the reconsidered determination submitted by Petitioner because CMS did not submit this document as a proposed exhibit.
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3. Petitioner factually reported in the pre-hearing brief accompanying her request for hearing that CMS issued the reconsidered determination "four (4) days before the [65] day reconsideration period expired," yet did not allege any basis for error related to the timing of CMS's issuance of the reconsidered determination.
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4. Petitioner's submissions do not comply with the Pre-Hearing Order, which requires that proposed exhibits be "[d]esignated with separate, unique, and whole identifying numbers beginning with "1" for each party."  Pre-Hearing Order § 9(c) (emphasis in original).  Nonetheless, I admit these exhibits.
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5. Because an in-person hearing for the purpose of cross-examination is unnecessary, I need not issue a ruling on CMS's motion for summary judgment.
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6. My findings of fact and conclusions of law are set forth in italics and bold font.
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7. Although Petitioner does not address the duration of the re-enrollment bar, I nonetheless note that the Departmental Appeals Board (DAB) has determined that a re-enrollment bar is not an appealable initial determination specified in 42 C.F.R. § 498.3(b).  Vijendra Dave, M.D., DAB No. 2672 at 11 (2016).
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8. Petitioner submitted a copy of a federal indictment charging that an owner of REMN engaged in a conspiracy to commit health care fraud.  P. Ex. L.  In detailing the manner and means of the conspiracy, the indictment reported that the "conspirators would and did offer and pay illegal bribes to medical practitioners to sign and to prescribe the orders for DME braces . . . regardless of medical necessity."  P. Ex. L at 18.  The indictment further explained that "often, the medical practitioners associated with telemedicine companies would and did sign the DME brace . . . orders without ever contacting the Medicare beneficiaries, rather than using the required interactive audio- and video-telecommunications system for a compliant telehealth consultation."  P. Ex. L at 19.  The basis for revocation set forth in 42 C.F.R. §§ 424.535(a)(10) and the documentation requirements outlined in 42 C.F.R § 424.516(f) for, inter alia, DMEPOS both originate from anti-fraud provisions of the Patient Protection and Affordable Care Act, P.L. 111-148, as amended by the Health Care and Education Reconciliation Act of 2010, P.L. 111-152, and the indictment exemplifies the utility of requiring physicians to maintain and retain documentation of DMEPOS orders to Medicare beneficiaries.  See 77 Fed. Reg. 25,284, 25,309-12 (Apr. 27, 2012).
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9. CMS subsequently broadened the scope of the requirement for physicians to maintain documentation.  84 Fed. Reg. 47,794, 47,835 (Sep. 10, 2019).
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10. Curiously, even though Petitioner block-quoted the response to the comment, she omitted the opening sentence of the response, which states the following:  "This final rule places the responsibility for the maintenance of records on both the ordering and certifying physician and both the provider and supplier."  77 Fed. Reg. at 25,310.
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11. The comments also stated that "such providers or suppliers should not be penalized in the same manner as a provider or supplier who intentionally or carelessly disregards the documentation requirements."  77 Fed. Reg. at 25,310.
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