Samson Assefa, M.D., DAB CR6474 (2024)

DECISION

The Medicare enrollment and billing privileges of Petitioner, Samson Assefa, M.D., were revoked effective September 18, 2020, pursuant to 42 C.F.R. § 424.535(a)(10)(i)¹ for noncompliance with 42 C.F.R. § 424.516(f)(2)(i).

Note Regarding Limited Review

The duration of a bar to reenrollment imposed by the Centers for Medicare & Medicaid Services (CMS) is not subject to review by an administrative law judge (ALJ) or the Departmental Appeals Board (the Board).  Heidy Woody, NP, DAB No. 3102 at 19-21 (2013).  However, when CMS determined to uphold a reenrollment bar of 10 years, that determination was based on a finding that Petitioner committed more than 10 violations of the record keeping and record access requirements of 42 C.F.R. § 424.516(f)(2)(i).  In this decision, I find and conclude Petitioner violated the requirements of 42 C.F.R. § 424.516(f)(2)(i) in the cases of seven Medicare beneficiaries.  Pursuant to 42 C.F.R.

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§ 424.535(a)(10)(ii), Petitioner is subject to revocation for no more than one year for each act of noncompliance, which I construe to be for each regulatory violation.  Therefore, CMS may wish to consider whether there were seven instances of noncompliance in this case based on seven regulatory violations or whether there were 14 instances of noncompliance because Petitioner both failed to maintain records for seven beneficiaries and then failed to grant CMS access to the records that were not maintained.  If CMS determines there were only seven instances of noncompliance, the period of revocation calculated under 42 C.F.R. § 424.535(a)(10)(ii) would be only seven years, and if the period of revocation controls the duration of the reenrollment bar imposed by CMS under 42 C.F.R. § 424.535(c), CMS may choose to reduce the reenrollment bar to comport with the limitation on the period of revocation applicable in this case.  If CMS determines there were 14 instances of noncompliance, no adjustment of the duration of the bar to reenrollment need be considered.

I.  Procedural History and Jurisdiction

Novitas Solutions, a Medicare administrative contractor (MAC), notified Petitioner by letter dated August 19, 2020, that Petitioner's Medicare enrollment and billing privileges were being revoked, effective September 18, 2020.  The MAC cited 42 C.F.R. § 424.535(a)(10) as the authority for revocation based on Petitioner's failure to maintain and provide access to documents requested by CMS or CMS contractors.  The MAC imposed a reenrollment bar of 10 years.  CMS Exhibit (Ex.) 1 at 38-40.

Petitioner requested reconsideration by letters dated December 12, 2020 and January 5, 2021.  CMS Ex. 1 at 7-10.  CMS notified Petitioner by letter incorrectly dated January 29, 2020,² that the revocation of his enrollment and billing privileges and the imposition of a 10-year reenrollment bar were upheld on reconsideration.  CMS Ex. 1 at 1-6.

Petitioner requested a hearing before an administrative law judge (ALJ) on March 19, 2021.  On March 22, 2021, the case was assigned to me for hearing and decision and my Standing Order was issued at my direction.  Petitioner's request for hearing was timely, the parties have not challenged my authority to decide this case, and I have jurisdiction.

On April 21, 2021, CMS filed a prehearing brief and motion for summary judgment with CMS Ex. 1.  On May 21, 2021, Petitioner filed a prehearing brief and a cross-motion for summary judgment with Petitioner's Exhibit (P. Ex.) 1.

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On October 21, 2021, I denied the motions for summary judgment.  I issued an order setting a hearing date for the case.  On November 8, 2021, Petitioner filed a letter offering to waive his³ right to appear and present evidence at an oral hearing.  On November 9, 2021, I denied the waiver of oral hearing and advised Petitioner that his testimony was required during the oral hearing.  On January 11, 2022, CMS filed three declarations marked as CMS Exs. 2 through 4.  The three declarations were from CMS's witnesses:  Minisha C. Hicks (CMS Ex. 2), Gina Blyther (CMS Ex. 3), and Lisa Small (CMS Ex. 4).  On January 12, 2022, I accepted the declarations subject to the witnesses being present at hearing to testify.

A hearing was convened by video teleconference on January 25, 2022.  A transcript (Tr.) of the proceedings was prepared and provided to the parties.  CMS offered CMS Exs. 1 through 4.  Petitioner did not object to my consideration of CMS Exs. 1 through 4, and all were admitted as evidence.  Tr. 16.  Petitioner offered P. Ex. 1.  CMS did not object to my consideration of P. Ex. 1, and I admitted P. Ex. 1 as evidence.  Tr. 16-17.  CMS called the three witnesses:  Gina Blyther, Team Lead, Division of Provider Investigations; Minisha Hicks, Esq., Director of the Division of Provider Enrollment Appeals (CMS Hearing Officer); and Lisa Small, an investigator for Safeguard Services, LLC (SGS), the CMS Northeastern Unified Program Integrity Contractor.  Petitioner also testified.

On March 18, 2022, CMS filed its post-hearing brief (CMS Br.) and Petitioner filed his post-hearing brief (P. Br.).  CMS filed a post-hearing reply brief on April 8, 2022 (CMS Reply).  Petitioner filed a post-hearing reply brief on May 2, 2022 (P. Reply).  On November 19, 2022, CMS filed CMS Exs. 5 and 6 in response to my order for CMS to produce additional evidence.  CMS Exs. 5 and 6 are admitted and considered as evidence.  On July 27, 2023, CMS filed a supplemental brief discussing a new decision issued by the Departmental Appeals Board.  Petitioner filed a supplemental brief in reply on August 1, 2023.  The supplemental briefs are accepted.

II.  Discussion

A.  Issue

Whether there is a basis for the revocation of Petitioner's Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10).

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B.  Applicable Law

Section 1831 of the Social Security Act (the Act) (42 U.S.C. § 1395j) establishes the supplementary medical insurance benefits program for the aged and disabled known as Medicare Part B.  Payment under the program for services rendered to Medicare-eligible beneficiaries may only be made to eligible providers of services and suppliers.⁴  Act §§ 1835(a) (42 U.S.C. § 1395n(a)), 1842(h)(1) (42 U.S.C. § 1395(u)(h)(1)).  Petitioner, a physician, is a supplier.  Administration of the Part B program is through the MACs.  Act § 1842(a) (42 U.S.C. § 1395u(a)).

The Act requires the Secretary of Health and Human Services (Secretary) to issue regulations that establish a process for the enrollment of providers and suppliers, including the right to a hearing and judicial review of certain enrollment determinations.  Act § 1866(j) (42 U.S.C. § 1395cc(j)).  Pursuant to 42 C.F.R. § 424.505, a provider or supplier must be enrolled in the Medicare program and be issued a billing number to have billing privileges and to be eligible to receive payment for services rendered to a Medicare-eligible beneficiary.

The Secretary delegated the authority to revoke enrollment and billing privileges to CMS and the MACs.  CMS and the MACs may revoke an enrolled supplier's Medicare enrollment and billing privileges and supplier agreement for any of the reasons listed in 42 C.F.R. § 424.535.  In this case, the MAC and CMS cited 42 C.F.R. § 424.535(a)(10) as the basis for revocation.  The regulation states:

(a) Reasons for revocation.  CMS may revoke a currently enrolled provider or supplier's Medicare enrollment and any corresponding provider agreement or supplier agreement for the following reasons:

* * * *

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(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).  Revocation under 42 C.F.R. § 424.535(a)(10)(i) is based in this case on the alleged violation of the physician document retention and access requirements established by 42 C.F.R. § 424.516(f):

(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).

(ii) The documentation includes written and electronic documents (including the NPI 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.

42 C.F.R. § 424.516(f)(2).  The regulation reflects by its reference to "Part A or B" that its application and requirements are limited to situations where the patient is a Medicare

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beneficiary.  Act tit. XVIII (42 U.S.C. §§ 1395-1395 lll).  Pursuant to 42 C.F.R. § 424.516(f)(2)(i)(A), records must be retained for seven years after the date of service.  Pursuant to 42 C.F.R. § 424.516(f)(2)(i)(B), the ordering, certifying, referring, or prescribing physician must give CMS or the Medicare contractor access to documentation required to be maintained under the regulation, including orders, certifications, and requests for payment, regardless of whether the records are physical documents or in electronic form.

Generally, when CMS revokes a supplier's Medicare billing privileges for not complying with enrollment requirements, the revocation is effective 30 days after CMS or its contractor mails notice of its determination to the supplier.  42 C.F.R. § 424.535(g).  After a supplier's Medicare enrollment and billing privileges are revoked, the supplier is barred from reenrolling in the Medicare program for one to 10 years.  42 C.F.R. § 424.535(c).  When revocation is pursuant to 42 C.F.R. § 424.535(a)(10)(i), as in this case, the regulation specifies that revocation is for not more than one year for each act of noncompliance.  42 C.F.R. § 424.535(a)(10)(ii).  It is not clear from the regulations that the period of revocation controls the duration of the reenrollment bar or that the 10-year limit on the reenrollment bar applies to the period of revocation.

A supplier whose enrollment and billing privileges are revoked may request reconsideration and review as provided by 42 C.F.R. pt. 498.  A supplier submits a written request for reconsideration to CMS or its contractor.  42 C.F.R. § 498.22(a).  CMS or its contractor must give notice of the reconsidered determination to the supplier, giving the reasons for its determination, specifying the conditions or requirements the supplier failed to meet, and advising the supplier of its right to an ALJ hearing.  42 C.F.R. § 498.25.  If the decision on reconsideration is unfavorable to the supplier, the supplier has the right to request a hearing by an ALJ and further review by the Board.  Act § 1866(j)(8) (42 U.S.C. § 1395cc(j)(8)); 42 C.F.R. §§ 424.545, 498.3(b)(17), 498.5(l)(2).  CMS is also granted the right to request ALJ review of a reconsidered determination with which it is dissatisfied.  42 C.F.R. § 498.5(l)(2).  The Departmental Appeals Board (Board) has previously concluded that in provider and supplier enrollment cases, including revocations of enrollment such as this case, ALJ review is limited to the basis for the contractor or CMS action cited in the reconsidered determination.  Neb Group of Ariz. LLC, DAB No. 2573 at 7 (2014); 42 C.F.R. § 498.5(l)(2).  A hearing on the record, also known as an oral hearing, is required under the Act unless waived.  Crestview Parke Care Ctr. v. Thompson, 373 F.3d 743, 748-51 (6th Cir. 2004).  The supplier bears the burden to demonstrate that it meets enrollment requirements with documents and records.  42 C.F.R. § 424.545(c).

The Secretary's regulations do not address the allocation of the burden of proof or the standard of proof.  However, the Board has addressed the allocation of the burden of proof under 42 C.F.R. pt. 498 in many decisions.  The standard of proof is a preponderance of the evidence.  CMS has the burden of coming forward with the

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evidence and making a prima facie showing of a basis, in this case, for revocation of Petitioner's enrollment.  "Prima facie" means generally that the evidence is "[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted."  Black's Law Dictionary (8th ed. 2004).  CMS has the initial burden of coming forward with sufficient evidence to show that its decision to revoke Petitioner's Medicare participation and billing privileges is legally sufficient under the Act and regulations.  CMS makes a prima facie showing of a basis for revocation if the credible evidence CMS relies on is sufficient to support a decision in its favor absent an effective rebuttal by Petitioner.  Petitioner bears the burden of persuasion to rebut the CMS prima facie showing by a preponderance of the evidence or to establish any affirmative defense.  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); Cross Creek Health Care Ctr., DAB No. 1665 (1998); Hillman Rehab. Ctr., DAB No. 1611 (1997) (remand), DAB No. 1663 (1998) (aft. remand), aff'd, Hillman Rehab. Ctr. v. United States, No. CIV-A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999).

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

My conclusions of law are set forth in bold followed by the pertinent findings of fact and analysis.

1.  Petitioner violated 42 C.F.R. § 424.516(f)(2)(i)(A) by failing to maintain required documents for seven years from the date he certified seven Medicare beneficiaries eligible for orthotics.

2.  Petitioner violated 42 C.F.R. § 424.516(f)(2)(i)(B) by failing to grant CMS or its contractors access to documents he was required to maintain for seven years from the date he certified seven Medicare beneficiaries eligible for orthotics.

3.  There is a basis for revocation of Petitioner's Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10)(i) for noncompliance with the requirements of 42 C.F.R. § 424.516(f)(2)(i) to maintain and give access to required documentation.

4.  I have no authority to review the CMS determination to impose a reenrollment bar when I conclude that there is a basis for the revocation of Medicare enrollment and billing privileges.

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a.  Facts

CMS's witness, Health Insurance Specialist (HIS) Gina Blyther, testified regarding background facts that explain why Petitioner was requested to produce patient records.  According to HIS Blyther, sometime before April 2019, there was a large federal investigation of the alleged payment of illegal kickbacks and bribes by DMEPOS⁵ suppliers in exchange for referrals for DMEPOS, specifically back, shoulder, wrist, and knee braces that were medically unnecessary, from medical professionals.  CMS Ex. 3 at 2 ¶¶ 5-7.  As a result of the investigation, in addition to criminal prosecutions, CMS suspended payments to 130 DMEPOS suppliers.  CMS Ex. 3 at 2 ¶¶ 6, 8.  CMS also undertook to investigate 707 physicians and/or others who ordered DMEPOS from the 130 suspended DMEPOS suppliers.  CMS Ex. 3 at 2 ¶¶ 9-10.  Petitioner was part of phase 2 of the investigation.  SGS was tasked by CMS with investigating Petitioner.  The investigative approach was to request that Petitioner produce the records for 20 Medicare beneficiaries for whom CMS records showed Petitioner ordered DMEPOS that was paid for by Medicare.  If Petitioner produced the records, they were to be examined to determine if Petitioner complied with Medicare requirements.  If Petitioner did not produce the records, he was subject to revocation of his Medicare enrollment and billing privileges.  CMS Ex. 3 at 3 ¶¶ 12, 14; CMS Ex. 4 at 2; Tr. 81-83, 89-90.

On January 23, 2020, SGS sent a request to Petitioner for the records of 20 Medicare beneficiaries with dates of service from January 1, 2016 through May 21, 2019.  The request was sent to Petitioner at his WRNMMC correspondence address.  CMS Ex. 1 at 12; CMS Ex. 4 at 2; Tr. 132.  The request enclosed a list but the copy of the list in evidence is so redacted that it has no evidentiary value.  CMS Ex. 1 at 15.  The records request was returned as undeliverable to SGS.  CMS Ex. 1 at 20; CMS Ex. 4 at 2 ¶¶ 5-6.

On July 15, 2020, SGS sent Petitioner a duplicate request for records.  CMS Ex. 1 at 22-26, 30-37; CMS Ex. 4 at 3 ¶ 7.  The copy of the list attached to the letter in evidence is also so heavily redacted as to have no evidentiary value.  CMS Ex. 1 at 25-26, 37.  The letter was sent to Petitioner's WRNMMC correspondence address.  CMS Ex. 1 at 23.  The MAC's initial determination dated August 19, 2020, indicates that both the requests for records sent to Petitioner by SGS were returned as undeliverable.  CMS Ex. 1 at 38; CMS Ex. 4 at 2-3 ¶¶ 5-8.

The MAC notified Petitioner on August 19, 2020, that his Medicare enrollment and billing privileges were revoked, effective September 18, 2020.  CMS Ex. 1 at 38-41.  The

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MAC explained that because the two records requests were returned as undeliverable, Petitioner failed to give CMS access to documentation in violation of 42 C.F.R. § 424.516(f).  CMS Ex. 1 at 38.  The MAC also advised Petitioner that he was subject to a 10-year bar to reenrolling in Medicare.  CMS Ex. 1 at 40.  Attached to the MAC's initial determination was a table with the names of the 20 Medicare beneficiaries, their dates of birth, and their Medicare beneficiary numbers.  Unlike the table previously sent by SGS, this list also included Petitioner's NPI and dates of service for each beneficiary.  The dates of service ranged from July 2018 to April 2019 (CMS Ex. 1 at 41), a much narrower range of dates of service than the first SGS request for documents (CMS Ex. 1 at 12).  Tr. 132.  The copy of the table sent with the initial determination in evidence as CMS Ex. 1 at 41, is only partially redacted and it retains evidentiary value.

Petitioner learned on October 8, 2020, that he could no longer order DMEPOS from DMEPOS suppliers.  On December 12, 2020, he learned from the MAC that his Medicare enrollment and billing privileges were revoked.  On December 18, 2020, he received a copy of the MAC's August 19, 2020 initial determination and the list of the 20 Medicare beneficiaries for whom records were requested.  CMS Ex. 1 at 7, 9; Tr. 139-40.

Petitioner requested reconsideration of the MAC's August 19, 2020 initial determination by letters dated December 12, 2020 and January 5, 2021.  CMS Ex. 1 at 7-10.  In his December 12, 2020 letter, Petitioner explained that he had not received the initial determination until December 12, 2020.  Petitioner asked CMS to re-send the records request and he would submit necessary medical records immediately.  CMS Ex. 1 at 8.

On December 28, 2020, CMS provided Petitioner copies of the medical records requests.  CMS also informed Petitioner that he had 30 days to respond to the records requests.  CMS Ex. 1 at 2.⁶

In his second reconsideration request of January 5, 2021, Petitioner stated that he provided telemedicine services to the 20 Medicare beneficiaries listed in the records requests.  Petitioner further stated that the medical records requested were unavailable because Peak Performance (Peak) was closed and could not be contacted, and the Peak website was down.  CMS Ex. 1 at 9.

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On January 29, 2021, CMS Hearing Officer Hicks issued a reconsidered determination upholding the revocation of Petitioner's Medicare enrollment and billing privileges and the imposition of a 10-year reenrollment bar.  The hearing officer cited 42 C.F.R. § 424.535(a)(10) as the basis for revocation, noting that Petitioner did not maintain documents required by 42 C.F.R. § 424.516(f)(2)(i) and (ii), and failed to give access to the documents when requested by CMS as required by 42 C.F.R. § 424.516(f)(2)(i).  CMS Ex. 1. At 1-4; CMS Ex. 2; Tr. 49-52. ⁷

Petitioner, a Maryland physician, was enrolled in Medicare.  His Medicare enrollment record showed he was employed by the Department of Defense Tricare program.  His correspondence address was listed as WRNMMC [Walter Reed National Military Medical Center], 8901 Wisconsin Avenue Bethesda MD, and both a telephone number and official "mail.mil" email address were listed.  CMS Ex. 1 at 42-44.

Petitioner testified at the January 25, 2022 hearing.  He testified that he had been enrolled in Medicare for seven and a half years.  Tr. 136.  Petitioner testified regarding his work history that he began working for the Department of Defense (DOD), primarily at the Fort Belvoir Community Hospital (Fort Belvoir) but also at WRAMMC, in July 2017.  Petitioner testified that he worked at Fort Belvoir as the director of the sleep medicine clinic since July 2017.  He also had hospital privileges at WRNMMC.  Tr. 135.  Petitioner explained that when he enrolled in Medicare, he gave CMS or the MAC WRNMMC as his correspondence address because he anticipated being at WRNMMC more than Fort Belvoir, though that did not happen.  Tr. 194-95.  He testified that prior to working for DOD, he worked at the University of Maryland for three years.

Petitioner testified that he worked for Mint Physicians for three months from June 21 to September 19, 2018.  Tr. 135, 137.  He described Mint Physicians as a staffing agency that has been around for about 25 years and assigns physicians to temporary positions throughout the United States.  He decided to work with Mint in 2018 as he needed extra

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money.  He only had one assignment through Mint with Peak.  He was tasked with evaluating whether patients were appropriate for orthotics.  He found that 50 to 60 percent were appropriate for orthotics.  Tr. 136-38, 146.  Petitioner testified that when he saw a patient through Peak, he reviewed patient records, interviewed the patient by telephone or video conference, prepared a detailed history, he recommended that the patient receive orthotics (knee, ankle or hip) or not, and he signed the patient's chart electronically.  He prepared no separate order but just checked the corresponding box for "approved" or "disapproved" and signed electronically.  Tr. 149-50.  Petitioner testified that he did not keep any records related to the patients he saw during his brief time with Mint.  He testified that he assumed that all the records would be saved in electronic format on the platform he used while working with Peak.  Tr. 151-52.  Petitioner testified he did not know how Peak ordered orthotics when he approved them for a patient, but he knew he did not prepare a separate order and simply checked a box.  Tr. 152-53.

Petitioner testified that on October 8, 2020, he learned from a DMEPOS company that he was not certified to order DMEPOS.  On December 12, 2020, he learned that his Medicare enrollment and billing privileges had been revoked.  On December 28, 2020, he received an unredacted copy of the list of Medicare beneficiaries that he believes are in evidence as CMS Ex. 1 at 25 and 26, hesitating in his identification due to the heavy redaction of the evidence.  On receiving the list, he checked DOD and University of Maryland records and determined he saw none of the Medicare beneficiaries on the list while working for either.  He then inferred that the Medicare beneficiaries were seen while he worked for Peak.  He admitted that in his reconsideration requests he stated that he saw the listed Medicare beneficiaries while providing them telemedicine services.  He assumed that the list provided to him by CMS or the MAC correctly listed Medicare beneficiaries that he saw.  However, at the time, the list he was provided did not list dates of service.  Based on the more detailed list placed in evidence as CMS Ex. 1 at 41, he determined that some of the dates of service were outside the narrow period he provided services through Peak.  He testified that he did not see any of the patients through Peak if their dates of service were outside the period June 21 to September 19, 2018.  Tr. at 140-46.  Petitioner testified that he saw roughly 366 patients through his assignment to Peak.  Tr. 148.  He testified that he had no recollection of any of the Medicare beneficiaries on any of the lists sent to him by CMS.  Tr. 155.

I have no reason to doubt the credibility of Petitioner's testimony.  Based on my review of CMS Ex. 1 at 41, only seven of the Medicare beneficiaries on the list had dates of service during the period June 21 to September 19, 2018, when Petitioner worked for Peak.  Tr. 146-47.  Petitioner does not deny that he possibly saw the seven Medicare beneficiaries while providing telemedicine services through Peak.  Tr. 147.  Petitioner does not deny that he personally kept no records related to services rendered to the seven beneficiaries.  Tr. 151.  He does not deny that he produced no records for the seven when requested by or on behalf of CMS.  He admitted on cross-examination that he knew Medicare rules required that he maintain records for his patients for seven years and that

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he had to produce the records upon CMS request.  Tr. 160.  The remaining 13 beneficiaries had dates of service in 2019, when Petitioner was not working for Peak.

The evidence shows it is more likely than not that the individuals listed on CMS Ex. 1 at 41, were Medicare beneficiaries.  CMS Ex. 4 at 2 ¶¶ 4, 7; CMS Exs. 5-6; Tr. 67-68, 120-22.

b.  Analysis

My review in this case is limited to whether CMS had a basis for revocation of Petitioner's Medicare enrollment and billing privileges.  If I conclude that there was a basis for revocation, then I must uphold the CMS reconsidered determination to revoke.   Heidy Woody, NP, DAB No. 3102 at 10, 16-17.

I conclude that there was a basis to revoke Petitioner's Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10)(i) for failure to meet the documentation requirements of 42 C.F.R. § 424.516(f).  Therefore, pursuant to 42 C.F.R. § 424.535(a)(10)(ii), Petitioner is subject to a period of revocation "for a period of not more than 1 year for each act of noncompliance."

The effective date of revocation is controlled by 42 C.F.R. § 424.535(g)(1), which provides that revocation is effective 30 days after CMS or the MAC mailed Petitioner the notice of the revocation determination.  The initial determination in this case is dated August 19, 2020.  CMS Ex. 1 at 38.  September 18, 2020, is the thirtieth day after August 19, 2020 and the effective date of revocation of Petitioner's Medicare enrollment and billing privileges.  The regulation leaves no room to argue that the effective date occurred after Petitioner received notice of the revocation.

Notice

The issue of notice requires a brief discussion.  P. Br. at 13.  Pursuant to 42 C.F.R. § 424.545(a), a provider or supplier denied enrollment in Medicare or whose Medicare enrollment is revoked may request review as provided by 42 C.F.R. pt. 498.  CMS or the MAC is required to mail notice of an initial determination to the party affected by the determination.  The notice must set forth "the basis or reasons for the determination, the effect of the determination, and the party's right to reconsideration, if applicable, or to a hearing."  42 C.F.R. § 498.20(a)(1).

In this case, there is no question that Petitioner did not receive the requests from SGS to produce records.  There has been some discussion between the parties about whether Petitioner was responsible for ensuring that CMS had his correct mailing address.  There is no question that under the regulations, Petitioner was obliged to ensure CMS had his correct mailing address.  42 C.F.R. §§ 424.510(d), 424.516(d).  However, Petitioner's

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failure in this regard was not cited a basis for revocation in the reconsidered determination and it is not considered further.

More concerning for Petitioner is the fact that the MAC proceeded with the revocation action despite the fact SGS, and by implication, the MAC, knew Petitioner never received any request for records from CMS through SGS.  The MAC made the initial determination to revoke Petitioner's Medicare enrollment and billing privileges and mailed the notice required by 42 C.F.R. § 498.20(a)(1) to Petitioner at the same address to which the SGS records requests were sent and retuned.  CMS Ex. 1 at 11-12, 17-23, 26-31, 33-34, 38.  Arguably, the MAC should have recognized that the initial determination addressed as it was, was unlikely to be received by Petitioner.  However, even if one concluded that Petitioner was deprived of the procedural due process provided for by regulation, I conclude the error was cured by CMS.  When Petitioner advised CMS that he had received no notices, CMS remedied any error by granting Petitioner 30 days to produce the requested records; by extending the time for him to request reconsideration; and by conducting reconsideration.  CMS Ex. 1 at 1-2.

Requirements:  To Maintain Records and Give Access to CMS

A physician such a Petitioner who "orders, certifies, refers, or prescribes," items, services, or drugs under Medicare Parts A or B must do two things:

1.  The physician must maintain documents specified by the regulation for 7 years from the date of service, i.e., the date of the order, certification, referral, or prescription for Medicare covered items; and

2.  The physician must provide CMS or the MAC access to the documentation when requested.

42 C.F.R. § 424.516(f)(2)(i).  The documentation includes written and electronic documents related to the orders, certification, referral, prescription, or requests for payment for Medicare covered services, items, or drugs.  42 C.F.R. § 424.516(f)(2)(ii).  These obligations are triggered when the patient involved is a Medicare beneficiary and Medicare coverage is under Part A or Part B of the Act.

The evidence shows that:

Petitioner worked for Mint providing telemedicine services through Peak, evaluating patients for the need for orthotics from June 21 through September 19, 2018.  Tr. 135, 137, 140-46.

Petitioner saw approximately 366 patients, and he approved an orthotic for 50 to 60 percent of the patients he saw from June 21 through September 19, 2018.  Tr.

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148.  The evidence does not show how many of the 366 were Medicare beneficiaries.

Petitioner completed all documentation through the Peak website, and he retained no copy of the records he created for his Peak patients.  Tr. 151.

CMS has placed in evidence a document produced based on CMS records that lists 20 Medicare beneficiaries by name and Medicare number, to show that orders were made to various DMEPOS suppliers using Petitioner's NPI⁸ and name.  CMS Ex. 1 at 41; CMS Exs. 5-6.

The preponderance of the evidence shows that Petitioner violated the requirement of 42 C.F.R. § 424.516(f)(2)(i)(A) to maintain documentation for any Medicare beneficiaries he may have seen through Peak during the period June 19 through September 21, 2018, for seven years.  The preponderance of the evidence also shows that Petitioner failed to grant CMS access to documentation for any Medicare beneficiaries he may have seen through Peak in violation of 42 C.F.R. § 516(f)(2)(i)(B).  A violation of either 42 C.F.R. § 424.516(f)(2)(i)(A) or (B) is a basis for revocation.  Heidy Woody, NP, DAB No. 3102 at 10.  Petitioner does not deny that he saw through Peak seven of the Medicare beneficiaries listed on CMS Ex. 1 at 41 with dates of service of July 3, 2018, and August 3, 7 and 8, 2018; that he maintained no records for the seven Medicare beneficiaries; and that he failed to give CMS access to records for the seven.  Accordingly, based on Petitioner's violations of 42 C.F.R. § 424.516(f)(2)(i), I conclude as a matter of law that there were bases for revocation of Petitioner's Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10)(i).

Period of Revocation and/or Duration of Bar to Reenrollment

CMS imposed a revocation of 10 years pursuant to 42 C.F.R. § 424.535(a)(10)(ii), which authorizes revocation for a period of no more than one year "for each act of noncompliance."  42 C.F.R. § 424.535(a)(10)(ii).  CMS imposed a reenrollment bar for the maximum period of 10 years as authorized by 42 C.F.R. § 424.535(c)(1)(i).  The CMS decision to impose a reenrollment bar and the period of the bar, and arguably the period of revocation, are not subject to ALJ or Board review.  Heidy Woody, NP, DAB No. 3102 at 19-21.

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If required to review the duration of the revocation or bar to reenrollment, I would conclude that 10 years is appropriate and reasonable.

Petitioner has shown by his credible testimony that he only saw patients through Peak from June 19 through September 21, 2018.  Based on my review of CMS Ex. 1 at 41, only seven of the listed Medicare beneficiaries had a date of service during the period from June 19 through September 21, 2018.  Petitioner concedes that he saw roughly 366 patients through Peak during that period, but the evidence does not show how many of those beyond the seven were Medicare beneficiaries.  Therefore, based on his admission he maintained no records for any of his Peak patients other than on the Peak website, the evidence shows Petitioner failed to maintain records for seven Medicare beneficiaries, i.e., he committed seven violations of 42 C.F.R. § 424.516(f)(2)(i)(A).  Petitioner is also found to have committed seven violations of 42 C.F.R. § 424.516(f)(2)(i)(B) because the CMS and the MAC requested records for only seven Medicare beneficiaries who the evidence shows Petitioner saw through Peak.

Pursuant to 42 C.F.R. § 424.535(a)(10)(ii), if revocation is based on violation of the requirement to maintain or grant access to documents, CMS has the discretion to revoke a provider's or supplier's Medicare enrollment and billing privileges for no more than one year for each violation.  The term "violation" is not defined by the regulation and there is no explanation about how to count violations.  For example, is there one violation or are there two violations if a provider or supplier fails to maintain a record for a Medicare beneficiary and fails to grant CMS access to that record if requested?  Pursuant to 42 C.F.R. § 424.535(c)(1), a provider or supplier whose Medicare enrollment and billing privileges are revoked is barred from participating in Medicare from the date of revocation until the reenrollment bar ends.  Except in circumstances not present in this case, CMS is authorized to impose a reenrollment bar of no more than 10 years.  42 C.F.R. § 424.535(c)(1)(i).  The regulations refer to a period of revocation and address the duration of a reenrollment bar.  The regulations do not explain if they are the same or not.  The regulations also do not explain whether the limit on the duration of the reenrollment bar CMS may impose also limits the period of revocation CMS may impose.  In this case, I would conclude that each failure to maintain a record for each Medicare beneficiary is a violation of the record keeping requirement of 42 C.F.R. § 424.516(f)(2)(i)(A).  Each failure to grant access to documentation that should be maintained, is a separate violation of 42 C.F.R. § 424.516(f)(2)(i)(B).  My interpretation is consistent with the plain language of the regulation which sets forth the requirements in separate subsection separated by the conjunction "and" indicating two duties are imposed or equal significance.

I also conclude that it is appropriate to treat the period of revocation and the duration of the reenrollment bar as meaning the same thing.  The drafters' choice to use such different language would normally indicate the drafters intended something different.

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However, treating the two as being the same and applying the upper limit of the reenrollment bar to Petitioner's case is to his benefit and less prejudicial.

Petitioner's Arguments

Petitioner makes four primary arguments:

1.  There is no evidence CMS or the MAC requested records for Petitioner's patients that he failed to produce;

2.  The CMS hearing officer erred by finding 20 acts of noncompliance;

3.  The evidence does not show Petitioner ordered any items that were billed to Medicare (which he asserts is necessary for revocation under 42 C.F.R. § 424.535(a)(10)); and

4.  The CMS hearing officer's finding Petitioner ordered medically unnecessary services from Medicare was erroneous.

P. Br. at 2-3; P. Reply at 2-6.  I conclude Petitioner's arguments are without merit.

Petitioner argues that CMS has failed to "meet its burden to make a prima facie case because there is not a shred of evidence in this case which documents that Dr. Assefa ordered any DMEPOS for Medicare beneficiaries."  P. Reply at 5; P. Br. at 6-11.  Petitioner asserts that CMS has failed to produce any evidence that any of the patients he saw through Peak were Medicare beneficiaries.  P. Reply at 5 n.3.  Petitioner's arguments are wrong.  The evidence shows Petitioner saw roughly 366 patients through Peak and he admits he maintained no records for those patients.  Furthermore, the preponderance of the evidence shows CMS through the MAC and SGS demanded records for at least seven Medicare beneficiaries the evidence shows Petitioner saw during the period he worked for Peak and for whom orthotics were ordered and paid for by Medicare.  The preponderance of the evidence shows Petitioner saw at least seven Medicare beneficiaries listed on CMS Ex. 1 at 41 while he worked with Peak; he certified them for orthotics; he maintained no records for any of the seven; and he gave CMS access to no records when requested.

Petitioner argues that he may be the victim of identity theft.  Petitioner posits that the claims listed on CMS Ex. 1 at 41 were likely fraudulent claims by DMEPOS suppliers that "likely [used] Dr. Assefa's NPI without his authorization to defraud Medicare."  P. Reply at 2-3; P. Br. at 6-11.  He further argues that CMS failed to consider the fact that the DMEPOS claims submitted by the DMEPOS suppliers cannot be considered credible because they were filed by DMEPOS suppliers that CMS believed were fraudulently billing Medicare.  P. Reply at 2-3; P. Br. at 13.  Petitioner consistently reiterates that the

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evidence shows that it is more likely than not that the claims filed by the DMEPOS suppliers, which were required to be accompanied by a physician's NPI to establish that there was a doctor's order supporting them, were likely to be fraudulent.  P. Reply at 7; Tr. 86.  To support his assertions, Petitioner indicates that CMS only has DMEPOS claims supported by Petitioner's NPI, which is publicly available, and has no records with Petitioner's signature.  P. Br. at 9; Tr. 88.  However, Petitioner relies on speculation and not evidence of actual identity theft.

Regarding the duration of the reenrollment bar, Petitioner argues that the CMS hearing officer erred by concluding Petitioner committed 20 records violations.  P. Br. at 14.  I have explained that I have no authority to review the duration of the bar to reenrollment or revocation and, if I did, I would uphold 10 years because Petitioner admitted he maintained no records for any of the patients he saw through Peak.  The evidence shows it is more likely than not Petitioner saw seven Medicare beneficiaries listed on CMS Ex. 1 at 41 but failed to maintain records for them or give CMS access to those records, amounting to 14 violations.

5.  I have no authority to grant equitable relief.

To the extent that Petitioner's arguments may be construed to be a request for equitable relief, I have no authority to grant equitable relief.  US Ultrasound, DAB No. 2302 at 8 (2010).  I am also required to follow the Act and regulations and have no authority to declare statutes or regulations invalid.  1866ICPayday.com, L.L.C., DAB No. 2289 at 14 (2009).

III.  Conclusion

For the foregoing reasons, I conclude that there were bases to revoke Petitioner's Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10)(i) for failure to comply with the documentation requirements of 42 C.F.R. § 424.516(f)(2)(i).

Endnotes

¹  Citations are to the 2019 revision of the Code of Federal Regulations (C.F.R.), unless otherwise stated.  I cite to the regulations in effect on August 19, 2020, the date of the initial revocation determination.

²  I infer that the date is a scrivener's error, and the date of the letter should have been January 29, 2021, after the dates of Petitioner's requests for reconsideration.

³  The pronouns he, his, and him are used as Petitioner has stated no other preference.

⁴  A "supplier" furnishes services under Medicare.  The term applies to physicians or other practitioners and facilities that are not included within the definition of the phrase "provider of services."  Act § 1861(d) (42 U.S.C. § 1395x(d)).  A "provider of services," commonly shortened to "provider," includes hospitals, critical access hospitals, skilled nursing facilities, comprehensive outpatient rehabilitation facilities, home health agencies, hospice programs, and a fund as described in sections 1814(g) and 1835(e) of the Act.  Act § 1861(u) (42 U.S.C. § 1395x(u)).  The distinction between providers and suppliers is important because they are treated differently under the Act for some purposes.

⁵  Durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS).  DMEPOS items are covered items under Part B of Title XIII of the Act.  Act § 1834.

⁶  Petitioner testified that he did not receive the list in evidence as CMS Ex. 1 at 41 on December 28, 2020, and he first saw the list when offered as an exhibit by CMS.  Rather, on December 28, 2020, he received an unredacted copy of the list sent by SGS with its demand letters which is in evidence as CMS Ex. 1 at 25-26.  Tr. 139-42.

⁷  The CMS or MAC determination to impose a bar to reenrollment and the duration of the bar are not subject to my review.  I note for the benefit of CMS, however, that Hearing Officer Hicks testified that she concluded that Petitioner failed to maintain documents for 20 Medicare beneficiaries and failed to provide CMS access to those documents.  She also testified that the maximum bar to reenrollment that could be imposed was 10 years, so it was not possible to bar Petitioner for 20 years.  Tr. 30.  I infer, based on her testimony, that Hearing Officer Hicks found there were 20 instances of noncompliance, i.e. regulatory violations.  One instance per Medicare beneficiary rather than 40 instances based on 20 violations of the requirement to maintain documents and 20 violations due to failure to give CMS access to the documents.

⁸  The National Provider Identifier (NPI) is a unique 10- digit identifier obtained by providers and suppliers to identify themselves in the Medicare system.  42 C.F.R. § 424.502; 45 C.F.R. §§ 162.404-.414; 69 Fed. Reg. 3434 (Jan. 23, 2004).