Frank B. Lee, M.D., DAB CR5967 (2021)

DECISION

A Centers of Medicare & and Medicaid Services’ (CMS) Unified Program Integrity Contractor (UPIC) investigated claims for durable medical equipment, orthotics and supplies (DMEPOS) that electronic Medicare program records allegedly show Frank B. Lee, M.D. (Petitioner) ordered for 20 Medicare beneficiaries.  The UPIC requested that Petitioner provide copies of medical records for the 20 beneficiaries in question.  Petitioner did not respond to the request.  The UPIC sent another request and warned that CMS may revoke Petitioner’s Medicare enrollment if Petitioner did not provide the requested records.  Petitioner, through counsel, responded that he needed more time to locate the records because Petitioner did not have the records for the 20 beneficiaries in question because he worked with four telehealth medicine companies and was inquiring with them to obtain the records.  At the time of this response, two of the telehealth companies had responded in the negative and the other two had yet to respond.  Based on Petitioner’s failure to maintain and provide beneficiary medical records, a Medicare Administrative Contractor (MAC) revoked Petitioner’s enrollment under 42 C.F.R. § 424.535(a)(10) and barred Petitioner from reenrollment for 10 years.  CMS upheld that determination.

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In this proceeding, Petitioner primarily argues that CMS failed to prove that the 20 beneficiaries identified by the UPIC were his patients.  Petitioner bases his defense on his testimony that the beneficiaries were not his patients.  To show that Petitioner issued physician orders for DMEPOS for the 20 beneficiaries identified by the UPIC, CMS presented testimony from a UPIC investigator and submitted signed orders from Petitioner for three of the 20 beneficiaries.  

As explained below, I find that CMS met its burden to make a prima facie showing that Petitioner ordered DMEPOS for the three beneficiaries for which CMS submitted physician orders.  Further, I find that CMS did not meet this burden regarding the remaining 17 beneficiaries because CMS merely presented testimony about its records without producing any actual records.  Finally, I find that Petitioner failed to rebut CMS’s prima facie case regarding the three beneficiaries for which CMS submitted copies of physician orders for DMEPOS.  Petitioner only provided his testimony to meet his burden of proof and, as explained below, that testimony is inadequate.  Therefore, I uphold the revocation of Petitioner’s enrollment in the Medicare program because Petitioner neither maintained records for those beneficiaries nor produced those records at CMS’s request in violation of 42 U.S.C. § 1395u(h)(9) and 42 C.F.R. § 424.535(a)(10). 

While the Departmental Appeals Board (DAB) has concluded that I generally do not have jurisdiction to review and modify the length of the reenrollment bar CMS imposes on a supplier, I conclude that, as a matter of law, the reenrollment bar in this case cannot exceed three years.  The statute governing the basis for revocation in this matter limits the reenrollment bar to a maximum of one year for each instance where a supplier failed to maintain records and provide those records to CMS on request. 42 U.S.C. § 1395u(h)(9). 

I. Background and Procedural History

Petitioner is a physician who was initially enrolled in the Medicare program from possibly as early as 1998 but no later than 2014.  CMS Ex. 7.  As a physician, Petitioner was considered a “supplier” for Medicare program purposes.  42 U.S.C. § 1395x(d).  

In an August 18, 2020 initial determination, a MAC revoked Petitioner’s Medicare enrollment effective September 17, 2020.  CMS Ex. 2 at 1.  The MAC also imposed a 10-year bar to reenrollment in the Medicare program.  CMS Ex. 2 at 3.  The basis for the revocation was as follows:

42 CFR § 424.535(a)(10) – Failure to Document or Provide CMS Access to Documentation 

On January 27, 2020, [a CMS UPIC] requested medical records for 20 beneficiaries for whom [Petitioner] had ordered items of DMEPOS.  A second medical records 

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request was sent on July 15, 2020.  The requests for records were sent to [Petitioner’s] correspondence address . . . and FedEx delivery confirmations were received.  To date, [the UPIC] has not received any of the records requested.  This failure to provide CMS access to documentation is in violation of 42 [C.F.R.] § 424.516(f).

CMS Ex. 2 at 1 (emphasis omitted).  

Petitioner requested reconsideration of the revocation.  CMS Ex. 3.  In that request, Petitioner admitted receiving the January and July 2020 requests for documentation.  CMS Ex. 3 at 1-2.  However, Petitioner also asserted that he had no documents to produce because there is no evidence that the beneficiaries listed in the January and July letters were Petitioner’s patients and Petitioner did not submit the Medicare claims forms for those beneficiaries.  CMS Ex. 2 at 2-3.  Petitioner also said he had not received reimbursement for seeing the listed beneficiaries.  CMS Ex. 3 at 2.  Petitioner asserted that:  “In the typical case, these orders are not done by “wet ink” signatures, but by electronic signature.  There is no proof [Petitioner] ordered the DME[POS] as is required for revocation under 42 CFR [424.]516(f).” CMS Ex. 3 at 2 (emphasis omitted).  

In an October 9, 2020 reconsidered determination, a CMS hearing officer upheld Petitioner’s revocation.  CMS Ex. 1.  The hearing officer found that Petitioner’s July 30, 2020 response to the second request for documents contained an admission that Petitioner treated the beneficiaries for whom the medical records were sought. CMS Ex. 1 at 3.  The hearing officer concluded that:

The fact that Medicare did not reimburse [Petitioner] directly for the services has no bearing on whether he was the physician who ordered or certified the need for DMEPOS.  In his July 30, 2020 letter, [Petitioner] admitted that he does not have possession or control of any of the requested medical records.  Such admission is sufficient to establish that [Petitioner] failed to comply with the documentation requirement at § 424.516(f)(2)(i)(A).  Furthermore, [Petitioner] did not provide the requested documentation when [the UPIC] requested it.  Because he did not provide the records when requested, [Petitioner] also failed to comply with the access requirement at § 424.516(f)(2)(i)(B).  As a result of [Petitioner’s] non-compliance with the documentation and access requirements at §§ 424.516(f)(2)(i)(A)-(B), CMS finds that the revocation of his Medicare enrollment pursuant to § 424.535(a)(10) is proper.

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CMS Ex. 1 at 3.  

Petitioner timely requested a hearing to challenge the revocation.  The Civil Remedies Division acknowledged receipt of the hearing request and issued my Standing Prehearing Order (SPO).  In response to the SPO, CMS submitted its prehearing exchange composed of a motion for summary judgment/prehearing brief and eight exhibits (CMS Exs. 1-8).  One of those exhibits was the written direct testimony for Wendy Naquin (CMS Ex. 8), a Lead Investigator with the UPIC.  Petitioner submitted his prehearing exchange composed of a cross-motion for summary judgment/prehearing brief and two exhibits (P. Exs. 1-2), both of which are written direct testimony for the following witnesses:  Daniel L. Tatum, Esq. (P. Ex. 1); and Petitioner (P. Ex. 2).  CMS waived its right to file a reply brief but filed a request to cross-examine Petitioner’s witnesses.  Petitioner did not request to cross-examine CMS’s witness.  

CMS also filed a response to Petitioner’s cross-motion for summary judgement and submitted four additional exhibits (CMS Exs. 9-12), which included a declaration from Leslie O’Neal (CMS Ex. 12), a manager from the UPIC.  CMS stated in its amended witness and exhibit list that the new evidence had only been provided to CMS recently by [the UPIC] and that the evidence was also submitted to show there were material facts in dispute. See SPO ¶ 7(e)(ii). 

Petitioner did not respond to CMS’s filing or object to the additional proposed exhibits.  SPO ¶ 6; Civil Remedies Division Procedures §§ 8(b), 13(d).  Further, Petitioner did not request to cross-examine Ms. O’ Neal.  

In an April 8, 2021 Notice of Hearing, I denied the parties’ motions for summary judgment and set this case for hearing on May 25, 2021.  For the reasons stated in the Notice of Hearing, I overruled Petitioner’s evidentiary objections and admitted CMS Exhibits 1 through 12 and Petitioner Exhibits 1 and 2 into the record.  Although CMS originally sought to cross-examine Petitioner, CMS withdrew that request.  Therefore, on May 25, 2021, I held a hearing at which CMS only cross-examined Mr. Tatum.  

Following the hearing, a hearing transcript (Tr.) was produced, the parties filed post hearing briefs (CMS Br. and P. Br.), and CMS filed a reply brief (CMS Reply).  

II. Issue

Whether CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment and billing privileges under 42 U.S.C. § 1395u and 42 C.F.R. § 424.535(a)(10).

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III. Jurisdiction

I have jurisdiction to hear and decide this case.  See 42 C.F.R. §§ 498.3(b)(17), 498.5(l)(2); see 42 U.S.C. § 1395cc(j)(8); 42 C.F.R. §§ 405.803(a); 424.545(a); 498.1(g).  

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

My findings of fact and conclusions of law are set forth in italics and bold font.

The Social Security Act (Act) authorizes the Secretary of Health and Human Services (Secretary) to establish regulations governing the enrolling of providers and suppliers in the Medicare program.  42 U.S.C. § 1395cc(j)(1)(A).  The Secretary promulgated enrollment regulations in 42 C.F.R. part 424, subpart P.  See 42 C.F.R. §§ 424.500-.570.  The regulations provide CMS with the authority to revoke the billing privileges of an enrolled provider or supplier if CMS determines that a provider or supplier violated a provision in 42 C.F.R. § 424.535(a).

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 National Provider Identifier (NPI) on them.  The written orders also include an electronic signature that could only be applied with a unique login password.

The record contains three documents entitled Detailed Written Order for Orthosis (Written Order).  CMS Exs. 9-11.

The first Written Order is for Medicare beneficiary J.L. for a lumbar-sacral orthosis (HCPCS Code L0650).  This Written Order provides the primary diagnoses as “Low Back Pain” and “Disorder of Lumbar” and the therapeutic objectives as “Reduce Pain,” “Reduce pain by restricting mobility to the trunk,” and “Support spine muscles and/or deformed spine.”  This Written Order is dated January 9, 2018. CMS Ex. 9 at 4-5.

The second Written Order is for Medicare beneficiary T.W. for a lumbar-sacral orthosis (HCPCS Code L0650). This Written Order provides the primary diagnoses as “Low Back Pain” and the therapeutic objectives as “Reduce Pain,” “Reduce pain by restricting mobility to the trunk,” and “Support spine muscles and/or deformed spine.”  This Written Order is dated January 17, 2018. CMS Ex. 10 at 4-5.

The third Written Order is for Medicare beneficiary C.C. for a wrist lumbar-sacral orthosis (HCPCS Code L3916). This Written Order provides the primary diagnoses as unspecified injuries, sprains, and strains of right and left wrists and the therapeutic objectives as “Reduce pain by immobilizing right wrist,” “Reduce pain by immobilizing

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left wrist,” and “Reduce Pain.”  This Written Order is dated January 10, 2018.  CMS Ex. 11 at 7.  

On the first two pages for each of the Written Orders, Petitioner’s name appears next to the words “Provider’s Signature.”  Petitioner’s name and NPI also appear below the signature line with the following statement:  

I, Dr. Frank B. Lee, MD, verify and confirm this order for the above named patient, and certify that I have personally performed the assessment of the patient for the prescribed treatment and device and verify that it is reasonably and medically necessary, according to accepted standards of medical practice within the community, for this patient’s medical conditions.  

CMS Ex. 9 at 4-5; CMS Ex. 10 at 4-5; CMS Ex. 11 at 7-8.  Each of the Written Orders include a sheet entitled E-Signature Protocol, which provides Petitioner’s name, NPI, the beneficiaries’ names and birth dates along with the following statement:

The e-signatures applied to the documents require attestation by the clinician and entry of the clinician’s unique login account password.  If the attestation is acknowledged and the account login password entered, then the created PDF documents are password protected with a unique document password, encrypted in a data store, and documents statistics are entered in a separate audit log.  

CMS Ex. 9 at 6; CMS Ex. 10 at 6; CMS Ex. 11 at 9.

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.

An investigator with a UPIC sent Petitioner a January 27, 2020 letter requesting documents from Petitioner as part of its review of DMEPOS claims. CMS Ex. 4.  The UPIC performs medical reviews for Medicare program integrity purposes and employs investigators who investigate Medicare claims for potential fraud, waste, or abuse. CMS Ex. 8 ¶¶ 2-3.  The UPIC sent the letter to Petitioner’s correspondence address as appearing in CMS records and FedEx confirmed receipt by Petitioner. CMS Ex. 4 at 1, 5; CMS Ex. 7 at 2; see CMS Ex. 3 at 1.

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The January 27, 2020 letter advised Petitioner that the UPIC was authorized by law and CMS to request documents from Petitioner and that “[t]he provider agreement to participate in the Medicare program requires [Petitioner] to submit all information necessary to support the [DMEPOS] claims where [Petitioner is] listed as the ordering physician.” CMS Ex. 4 at 2.  Attached to the letter was a list of 20 Medicare beneficiaries and the relevant dates of service that would correspond to the requested documents. CMS Ex. 4 at 2, 4.  The letter informed Petitioner that the UPIC wanted “any and all documentation to support the medical necessity of the [DMEPOS] billed for the specified dates of service” and provided a list of the types of documents Petitioner should provide. CMS Ex. 4 at 2.  The letter gave Petitioner 45 days to submit the requested documents and stated that a failure to do so would result in a determination that an overpayment has been made to the DMEPOS supplier. CMS Ex. 4 at 2.  

Petitioner did not respond to the January 27, 2020 letter.  CMS Ex. 5 at 1; see CMS Ex. 3 at 1; P. Ex. 2 at 1. 

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. 

UPIC investigator Wendy Naquin sent a second letter to Petitioner, dated July 15, 2020, that was nearly identical to the January 27, 2020 letter.  The letter included the following new information about Petitioner’s obligation to provide the requested documents and the potential ramifications for falling to do so:

If the requested medical records documentation is not received within fifteen (15) days from the date of this letter, July 30, 2020, administrative action, including revocation, may be taken.  As per 42 CFR § 424.516(f)(2)(i)(A) and (B), a physician or, when permitted, other eligible professional who orders items of DMEPOS is required to maintain documentation for seven (7) years from the date of the service; upon request of CMS or Medicare contractor, to provide access to that documentation.  Any provider that does not comply with these requirements is subject to a revocation under 42 CFR § 424.535 (a)(10)[.]

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CMS Ex. 5 at 2.  Petitioner received this letter.  CMS Ex. 3 at 1; CMS Ex. 5 at 5.

By letter dated July 30, 2020, Petitioner’s attorney, Daniel L. Tatum, Esq., responded to Ms. Naquin. Mr. Tatum documented that he had requested additional time to locate and provide the requested records, but the UPIC denied that request. Mr. Tatum indicated that he wrote the letter to give Ms. Naquin an update of Petitioner’s efforts and to assure her that Petitioner was continuing to try to obtain the requested documents.  In doing so, he explained that Petitioner did not possess the requested documents because he contracts his services to telemedicine companies. Mr. Tatum stated:

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 your request. He has, however, made efforts to obtain them. He has contacted the four telemedicine companies with which he does business.  Two have said they do not have the requested records, and he has not yet heard back from the other two.

CMS Ex. 6.

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.

Several CMS regulatory enforcement actions, including the revocation of Medicare enrollment, are adjudicated under the procedural regulations in 42 C.F.R. pt. 498 (Part 498 regulations).  See 42 C.F.R. §§ 498.3, 498.5. More than 20 years ago, the DAB interpreted the Part 498 regulations to include evidentiary burden shifting. Specifically, if a Medicare provider challenges the existence of a regulatory deficiency, CMS must make a prima facie case that the provider failed to substantially comply with federal requirements, and, if this occurs, the provider must then prove substantial compliance by a preponderance of the evidence.  Hillman Rehab. Ctr., DAB No. 1611 (1997); see Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001).

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In Hillman, the DAB explained that, when a provider disputes a CMS determination of noncompliance, CMS has to provide evidence of the basis for its determination.  If CMS fails to do this, Petitioner will prevail.  The DAB stated it this way:  

HCFA1 did not dispute that it has the burden of coming forward with evidence establishing a prima facie case that Hillman substantially failed to comply with program requirements.  This is appropriate because HCFA’s determination to terminate a provider agreement must be legally sufficient under the statute and regulations.  We agree with the ALJ that HCFA must identify the legal criteria to which it seeks to hold a provider.  Moreover, to the extent that a provider challenges HCFA's findings, HCFA must come forward with evidence of the basis for its determination, including the factual findings on which HCFA is relying and, if HCFA has determined that a condition of participation was not met, HCFA's evaluation that the deficiencies found meet the regulatory standard for a condition-level deficiency.

* * * * *

The burden remains on the provider to show that it continues to qualify under the Act and regulations.

* * * * *

Similarly, we find no basis for concluding that HCFA would somehow lack the incentive to make a prima facie case simply because HCFA does not have the ultimate burden of persuasion.  If HCFA has the burden of coming forward with evidence sufficient to establish a prima facie case and does not do so, then HCFA would lose even if the provider presents no evidence.  

Hillman, DAB No. 1611.  The DAB considers this prima facie case requirement/burden shifting to apply to all cases adjudicated under the Part 498 regulations, including cases involving the revocation of enrollment in the Medicare program. Adora Healthcare

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Services, Inc., DAB No. 2714 at 3-4 (2016); Medisource Corp., DAB No. 2011 at 2-3 (2006).

In the present case, it is undisputed that Petitioner did not maintain records for the 20 beneficiaries that the UPIC identified in its requests to Petitioner.  Further, the record is clear that Petitioner did not provide any records to the UPIC in response to the requests.  However, 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.

CMS provides three types of evidence to support its case.  The first is the UPIC’s list of 20 beneficiaries that the UPIC sent to Petitioner along with testimony from a UPIC investigator declaring that a review of CMS’s electronic records shows the list is accurate.  The investigator testified as follows: 

Medicare’s records show that the billing providers listed in paragraph 5 submitted claims for payment to Medicare for 20 Medicare beneficiaries in January and February of 2018 where Dr. Frank Lee was listed as the ordering physician for durable medical equipment.  [The UPIC] also provided this list to Dr. Lee in our requests in our January 27, 2020 and July 15, 2020 requests for medical records.  CMS Ex. 4 at 4; CMS Ex. 5 at 4. The same list was also included in Dr. Lee’s August 18, 2020 revocation notice letter.  CMS Ex. 2 at 4[.]

CMS Ex. 8 ¶ 6.  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.  

The second evidentiary basis to CMS’s case is Mr. Tatum’s letter to the UPIC on Petitioner’s behalf in response to the second request from the UPIC.  The CMS hearing officer relied almost exclusively on this evidence in her reconsidered determination.

In his request for reconsideration, Dr. Lee claims that CMS has not provided any evidence that the claims in question were for beneficiaries treated by Dr. Lee, or for DMEPOS that he ordered or certified.  However, in his July 30, 2020 response to [the UPIC’s] July 15, 2020 letter, Dr. Lee admitted that he treated the relevant patients through his contracts with several telemedicine companies.

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CMS Ex. 1 at 3 (citation omitted).

There is no doubt that Mr. Tatum’s July 30, 2020 letter indicates that “[t]he patient encounters represented by the requested records were all via telemedicine, arranged by the telemedicine companies [with which Petitioner has contracts].” CMS Ex. 6.  However, it is equally clear that neither Mr. Tatum nor Petitioner knew whether the telemedicine companies had the records sought by the UPIC.  Rather, Mr. Tatum was conveying to the UPIC that Petitioner was still inquiring with the telemedicine companies to find out if they had the records. CMS Ex. 6.  

In this proceeding, Mr. Tatum denies that he intended to admit that Petitioner had treated the 20 beneficiaries in question.  Rather, he testified that “I was relying upon the statement by CMS on this subject, that the patients were legitimate.  I speculated as to why the records could not be found and asked for more time to investigate.” P. Ex. 1. He further testified that Petitioner had not said to him that Petitioner had provided services to the beneficiaries on the UPIC’s list.  Tr. at 14.  Mr. Tatum also stated that he never saw medical records related to the listed beneficiaries. Tr. at 14.

Petitioner testified consistently with Mr. Tatum that Petitioner never told Mr. Tatum that records existed for the beneficiaries on the UPIC list or that Petitioner authorized Mr. Tatum to tell CMS that “the patients do exist.”  P. Ex. 2.

Based on the context of Mr. Tatum’s July 30, 2020 letter, which indicated that Petitioner was still investigating whether one of the telehealth medicine companies had documents related to the 20 beneficiaries identified on the UPIC’s list, and the testimony from Mr. Tatum and Petitioner, I find that the July 30, 2020 letter does not constitute an admission by Petitioner that he had ordered DMEPOS for the 20 beneficiaries identified by the UPIC.  Therefore, I do not find that the letter suffices for CMS to meet its burden to make a prima facie showing that Petitioner ordered DMEPOS for the 20 beneficiaries at issue.

Finally, CMS submitted three Written Orders electronically signed by Petitioner for three of the 20 beneficiaries. CMS Exs. 9-11. As discussed above, these Written Orders have Petitioner’s NPI and are electronically signed by Petitioner.

I consider these documents reliable because a UPIC manager testified that the Written Orders, as well as the other documents in CMS Exhibits 9 through 11, are true and accurate copies of documents the UPIC received from Medicare suppliers Nationwide Medical, LLC and Heart Homecare, LLC.  CMS Ex. 12 ¶¶ 5, 7.  CMS Exhibits 9 through 11 also include the letters to Nationwide Medical, LLC and Heart Homecare, LLC acknowledging Medicare claims had been filed as well as the documents received from those companies in response to that letter in support of the claims.  The Written Orders are part of each claim submission. Therefore, I conclude that these documents are

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sufficient for CMS to meet its prima facie evidence burden as it related to three beneficiaries and three Written Orders.2

Petitioner did not specifically object to CMS Exhibits 9 through 12 and did not request to cross-examine the UPIC manager who provided written testimony about those exhibits.  However, in briefing, Petitioner raises many evidentiary objections generally to CMS’s exhibits based on the Federal Rules of Evidence.  Petitioner also argues that “there 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.”  P. Br. at 2 (emphasis omitted). Petitioner further argues that “CMS has produced not one single medical record (billing or otherwise) showing what CMS claims.  To-wit, that any services, whatsoever, have been ordered for any or the 20 alleged patients . . . .”  P. Br. at 2-3.

In addition, Petitioner primarily relies on his testimony to meet his evidentiary burden. Petitioner testified that he produced no records concerning the 20 beneficiaries because there is no evidence that any of them were Petitioner’s patients. Petitioner also testified that he is the custodian of records for his practice and that “I offer this lack of records as proof that:  A) the evidence be admitted to prove that the patient encounter did not occur or exist; (B) a record would have regularly been kept for a matter of that kind; and (C) CMS does not show that the possible source of the information nor other circumstances indicate a lack of trustworthiness.”  P. Ex. 2 at 1. Petitioner also stated that he does not physically sign claims forms and that “the ancillary service provider” would bill Medicare.  P. Ex. 2 at 1.

As an initial matter, I have already admitted evidence into the record and will not entertain additional objections at this stage.  However, I note that the Federal Rules of Evidence do not apply in these proceedings. 42 C.F.R. § 498.61; see 42 U.S.C. § 405(b)(1).  Having admitted CMS Exhibits 9 through 12 into the record, these documents provide evidence that Petitioner ordered DMEPOS for three beneficiaries on the UPIC’s list. Finally, I do not conclude that Petitioner’s testimony meets his burden to show that the three Written Orders submitted by CMS are insufficient proof that he ordered DMEPOS for three of the beneficiaries in question. I find that Petitioner’s efforts to obtain medical documents from the telehealth companies that he worked for, after determining that Petitioner did not have possession or control of the requested documents, suggests that Petitioner believed his system of documentation was not perfect. See CMS Ex. 6.  If Petitioner were certain of his record keeping, he would have

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simply responded to the UPIC that none of the 20 beneficiaries were his patients.  Instead, he needed to inquire with the telehealth companies. CMS Ex. 6; Tr. at 15 (testimony that Petitioner had contacted the telehealth companies).  Because Petitioner’s actions indicate a lack of confidence in his record keeping, I cannot accept his testimony as definitive that he did not order DMEPOS for the 20 beneficiaries.  

Further, I note that Petitioner did not respond to the UPIC’s first request for documentation.  That failure evidences a possible effort by Petitioner to evade the request.  

5. CMS was authorized to revoke Petitioner’s Medicare enrollment and billing privileges under 42 U.S.C. § 1395u(h)(9) 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.

The Medicare program will make no payment for items and services unless they are “reasonable and necessary.” 42 U.S.C. § 1395y(a)(1)(A).  For Medicare program purposes, “leg, arm, back, and neck braces” are considered to be “medical and other health services.”  42 U.S.C. § 1395x(s)(9).  The Secretary’s regulations include leg, arm, back, and neck braces under the category of medical supplies, appliances and devices. 42 C.F.R. § 410.36(a)(3).

To receive payment for furnishing these braces, a Medicare supplier must comply with the conditions of payment for DMEPOS.  42 C.F.R. § 410.36(b).  Among those conditions is the following:  “All DMEPOS items require a written order/prescription for Medicare payment.”  42 C.F.R. § 410.38(d)(1).  The regulations define a “Written Order/Prescription” as “a written communication from a treating practitioner that documents the need for a beneficiary to be provided an item of DMEPOS.”  42 C.F.R. § 410.38(c)(4).  The elements of a written order/prescription include the treating practitioner’s name, signature, and NPI.  42 C.F.R. § 410.38(d)(1)(i)(E)-(F).

A DMEPOS supplier “must maintain the written order/prescription and the supporting documentation provided by the treating practitioner and make them available to CMS and its agents upon request.”  42 C.F.R. § 410.38(d)(3). In addition, the physician ordering DMEPOS must also maintain the supporting documentation for the order for seven years and provide access to that documentation to CMS or a CMS contractor upon request.  The relevant regulation states:  

(i) A physician who orders/certifies home health services and the physician or, when permitted, other eligible professional who orders items of DMEPOS or clinical laboratory or imaging services is required to -

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(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).

(ii) The documentation includes written and electronic documents (including the NPI of the physician who ordered/certified the home health services and the NPI of the physician or, when permitted, other eligible professional who ordered the items of DMEPOS or the clinical laboratory or imaging services) relating to written orders or certifications or requests for payments for items of DMEPOS and clinical laboratory, imaging, and home health services.

42 C.F.R. § 424.516(f)(2) (emphasis added).3

Congress established the following as a basis for revoking a supplier’s Medicare enrollment: 

The Secretary may revoke enrollment, for a period of not more than one year for each act, for a physician or supplier under section 1395cc(j) of this title 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, certifications for home health services, or referrals for other items or services written or ordered by such physician or supplier under this subchapter, as specified by the Secretary.

42 U.S.C. § 1395u(h)(9). The regulations implementing this statute state that CMS may revoke if:

(i) The provider or supplier did not comply with the documentation or CMS access requirements specified in § 424.516(f) of this subpart.

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42 C.F.R. § 424.535(a)(10).  

In the present case, there is no dispute that Petitioner did not maintain medical records, as required by 42 C.F.R. § 424.516(f)(2), for the three beneficiaries identified in the Written Orders that are part of the record. Further, Petitioner admits that he provided no documents related to those orders to the UPIC or CMS in response to either of the written requests. P Ex. 2 at 2.  Therefore, I uphold CMS’s determination to revoke Petitioner’s Medicare enrollment.  

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).

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.

In the initial determination, the MAC 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 as follows: 

(ii) A provider or supplier that meets the revocation criteria specified in paragraph (a)(10)(i) of this section, is

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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). This limitation is based on statute. 42 U.S.C. § 1395u(h)(9).

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 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. 

V. Conclusion

For the reasons explained above, I affirm CMS’s determination to revoke Petitioner’s Medicare enrollment. However, the maximum length of the reenrollment bar is limited to three years.

1. CMS was “formerly the Health Care Finance Administration (HCFA).” 42 C.F.R. § 400.200 (definition of CMS).
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2. This finding should not be construed as implying that CMS can only meet its burden in similar cases by providing the orders issued by a physician. In the present case, those orders are the only evidence in the record sufficient to meet the burden. However, had CMS filed documentation from its records, that may have been sufficient to meet the burden as well.
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3. The quotation reflects the regulation in effect when Petitioner signed the three Written Orders in this case. However, CMS subsequently broadened the scope of the requirement for physicians to maintain documentation. 84 Fed. Reg. 47794, 47835 (Sep. 10, 2019). The outcome of this case would not be altered if the amended version of the regulations were applied instead of the original version.
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