Salman M. Akbar, MD, CR6485 (2024)

DECISION

Petitioner’s Medicare enrollment and billing privileges are revoked pursuant to 42 C.F.R. § 424.535(a)(13)¹ effective July 13, 2022.  There is a basis for listing Petitioner’s name on the Centers for Medicare & Medicaid Services (CMS) Preclusion List for the duration of his five-year reenrollment bar. 

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I. Background

On June 13, 2022, Palmetto GBA, a Medicare administrative contractor (MAC) notified Petitioner of its initial determination to revoke Petitioner’s Medicare enrollment and billing privileges effective July 13, 2022, to impose a five-year reenrollment bar, and to add Petitioner’s name to CMS’s Preclusion List.  The MAC cited 42 C.F.R. § 424.535(a)(13) as authority for the revocation.  CMS Exhibit (Ex.) 3. 

Petitioner requested reconsideration by letter dated August 16, 2022.  CMS Ex. 2.  A CMS hearing officer issued a reconsidered determination on October 18, 2022, upholding revocation under 42 C.F.R. § 424.535(a)(13), the five-year reenrollment bar, and adding Petitioner’s name to CMS’s Preclusion List.  CMS Ex. 1. 

On December 14, 2022, Petitioner timely requested a hearing (RFH) before an administrative law judge (ALJ).  The case was assigned to me for hearing and decision and my Standing Order was issued on December 15, 2022.  There has been no challenge to my jurisdiction. 

On January 17, 2023, CMS filed a combined prehearing brief and motion for summary judgment (CMS Br.) with CMS Exs. 1 through 9.  Petitioner failed to file a response to the CMS motion or cross-motion for summary judgment, his prehearing brief, proposed exhibits, and an exhibit and witness list.  I ordered on February 22, 2023, that Petitioner show cause why his case should not be dismissed for violation of my Standing Order or for abandonment.  Petitioner responded to the order to show cause on March 2, 2023 (P. Response).  Petitioner requested that this case be decided on the current record based on the arguments in his request for hearing and attachments, which I construe to be a waiver of oral hearing.  P. Response at 2.  Petitioner’s request for hearing is treated as setting forth his arguments in support of his position.  CMS filed a waiver of reply on March 17, 2023. 

Petitioner did not object to CMS Exs. 1 through 9, and they are admitted and considered as evidence.  Petitioner filed with his request for hearing documents designated exhibits A through L (RFH Ex. A through L), which, in the absence of objection by CMS, are admitted and considered as evidence.² 

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II. Discussion

1. 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.  Administration of the Part B program is through the MACs.  Act § 1842(a) (42 U.S.C. § 1395u(a)).  Payment under the program for services rendered to Medicare-eligible beneficiaries may only be made to eligible providers of services and suppliers.³ Act §§ 1835(a) (42 U.S.C. § 1395n(a)), 1842(h)(1) (42 U.S.C. § 1395u(h)(1)).  Petitioner, a physician, is a supplier under the Act.  Act § 1861(d), (q), (r) (42 U.S.C. § 1395x(d), (q), (r)); 42 C.F.R. § 424.502. 

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

The Secretary has delegated the authority to revoke enrollment and billing privileges to CMS.  42 C.F.R. § 424.535.  CMS or a MAC has discretion to 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.  Pursuant to 42 C.F.R. § 424.535(a)(13), CMS may revoke a supplier’s Medicare billing privileges if a physician’s Drug Enforcement Administration (DEA) Certificate of Registration (COR) to dispense a controlled substance is currently suspended or revoked or is surrendered in response to an order to show cause, or if the applicable licensing or administrative body for any state in which the physician practices suspends or revokes the physician’s ability to prescribe drugs.

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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.  However, when a revocation is based on a federal exclusion or debarment, felony conviction, state license suspension or revocation, the revocation is effective with the date of exclusion or debarment, felony conviction, license suspension or revocation.  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, except in limited circumstances that do not exist in this case.  42 C.F.R. § 424.535(c).

Effective June 15, 2018, CMS was required to establish a preclusion list as defined by 42 C.F.R. §§ 422.2 and 423.100.  There is only one preclusion list.  83 Fed. Reg. 16,440, 16,641-67 (Apr. 16, 2018).  The preclusion list is defined in both the Medicare Part C regulations and the Medicare Part D regulations. 

Preclusion list means a CMS compiled list of individuals and entities that—

(1) Meet all of the following requirements:

(i) The individual or entity is currently revoked from Medicare for a reason other than that stated in [42 C.F.R.] § 424.535(a)(3) of this chapter.

(ii) The individual or entity is currently under a reenrollment bar under [42 C.F.R.] § 424.535(c).  

(iii) CMS determines that the underlying conduct that led to the revocation is detrimental to the best interests of the Medicare program.  In making this determination under this paragraph (1)(iii), CMS considers the following factors:

(A) The seriousness of the conduct underlying the individual’s or entity’s revocation.  

(B) The degree to which the individual’s or entity’s conduct could affect the integrity of the Medicare program.  

(C) Any other evidence that CMS deems relevant to its determination; or

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(2) Meet both of the following requirements:

(i) The individual or entity has engaged in behavior, other than that described in [42 C.F.R] § 424.535(a)(3) of this chapter, for which CMS could have revoked the individual or entity to the extent applicable had they been enrolled in Medicare.

(A) The seriousness of the conduct involved.  

(B) The degree to which the individual’s or entity’s conduct could affect the integrity of the Medicare program; and

(C) Any other evidence that CMS deems relevant to its determination; or

(3) The individual or entity, regardless of whether they are or were enrolled in Medicare, has been convicted of a felony under Federal or State law within the previous 10 years that CMS deems detrimental to the best interests of the Medicare program.  Factors that CMS considers in making such a determination under this paragraph (3) are—

(i) The severity of the offense;

(ii) When the offense occurred; and

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

42 C.F.R. § 422.2 (italics in original).  The definition applicable to Medicare Part D at 42 C.F.R. § 423.100 is virtually identical except that the regulation refers to “prescriber” rather than “individual or entity.”  No payment under Medicare Parts C and D may be made to anyone on the preclusion list.  42 C.F.R. §§ 422.222-.224, 422.504(i)(2)(v), 423.120(c)(6).  CMS must notify a supplier in writing that the supplier is being added to

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the preclusion list, the basis for the action, and inform the supplier of the right to ALJ review and appeal pursuant to 42 C.F.R. pt. 498.  42 C.F.R. §§ 422.222(a)(2); 423.120(c)(6)(v). 

The regulations establish three independent grounds for placing an individual, entity, or prescriber on the CMS preclusion list.  Neither of the second two grounds listed in the regulations apply in this case because revocation of Petitioner’s Medicare enrollment and billing privileges was pursuant to 42 C.F.R. § 424.535(a)(13) based on the DEA’s revocation of Petitioner’s DEA COR and not based on his conduct.  Whether CMS had a basis to place Petitioner on the preclusion list under 42 C.F.R. §§ 422.2 and 423.100 must, therefore, be resolved on the first ground considering whether:  (1) Petitioner is currently revoked for Medicare for a reason other than that stated in 42 C.F.R. § 424.535(a)(3); (2) Petitioner is currently under a reenrollment bar under 42 C.F.R. § 424.535(c); and (3) CMS determined that the underlying conduct that led to his revocation is detrimental to the Medicare program’s best interests based on the seriousness of the conduct giving rise to Petitioner’s revocation, the degree to which Petitioner’s conduct could affect the integrity of the Medicare program, and any other information CMS deems relevant. 

A supplier whose enrollment and billing privileges have been revoked or who has been placed on the preclusion list may request reconsideration and review as provided by 42 C.F.R. pt. 498.  42 C.F.R. §§ 424.545(a); 422.222(a)(2); 423.120(c)(6)(v).  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 its reconsidered determination to the supplier, giving the reasons for its determination and specifying the conditions or requirements the supplier failed to meet, and the 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), (20), 498.5.  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).  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 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 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

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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). 

Revocation and preclusion list review is strictly limited to whether there is a basis for the revocation and for adding the supplier to the CMS preclusion list.  Douglas Bradley, M.D., DAB No. 2663 at 13 (2015); 83 Fed. Reg. at 16,642.  The Board has consistently held that ALJ review of the CMS revocation determination is limited to whether CMS had a legal basis for revocation.  Letantia Bussell, M.D., DAB No. 2196 at 10 (2008).  If CMS establishes the elements necessary for revocation, “revocation must be sustained, and neither the [ALJ] nor the Board may ‘substitute its discretion for that of CMS in determining whether revocation was appropriate under all the circumstances.’”  Douglas Bradley, M.D., DAB No. 2663 at 13 (quoting Abdul Razzaque Ahmed, M.D., DAB No. 2261 at 19 (2009), aff’d Ahmed v. Sebelius, 710 F. Supp. 2d 167 (D. Mass. 2010) (footnote omitted)). 

2. Issues

   Whether there was a basis for revocation of Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(13); and

   Whether there is a basis to list Petitioner on the CMS Preclusion List. 

3. 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.  The findings of fact are based on the exhibits admitted.  I have carefully considered all the evidence and the arguments of both parties, though not all may be specifically discussed in this decision.  I discuss in this decision the credible evidence

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given the greatest weight in my decision-making.⁴ I also discuss any evidence that I find is not credible or worthy of weight.  The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ.  There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so.  Charles H. Koch, Jr., Admin L. & Prac. § 5:64 (3d ed. 2013). 

1. Petitioner waived the right to an oral hearing and decision on the documentary evidence and briefs is appropriate.  

A Petitioner whose enrollment has been revoked and/or who has been placed on the preclusion list has a right to a hearing and judicial review, and a hearing on the record is required under the Act.  Act §§ 205(b) (42 U.S.C. § 405(b)), 1866(h)(1), (j) (42 U.S.C. §§ 1395cc(h)(1), (j)); 42 C.F.R. §§ 498.3(b)(17), 498.5; Crestview Parke Care Center v. Thompson, 373 F.3d 743, 748-51 (2004).  A party may waive appearance at an oral hearing but must do so affirmatively in writing.  42 C.F.R. § 498.66(a).  If a Petitioner waives the right to appear and present evidence, no hearing is required.  42 C.F.R. § 498.66(b).  In this case, Petitioner waived the right to oral hearing.  P. Response.  I conclude that the waiver is acceptable.  CMS did not object to the waiver.  Accordingly, no oral hearing is necessary and decision on the documentary evidence and briefs is appropriate. 

2. On September 20, 2021, the DEA Administrator published an order in the Federal Register in which she revoked Petitioner’s DEA COR, effective October 20, 2021.  
3. The Secretary has determined and provided by regulation that CMS may revoke the Medicare enrollment of a supplier whose DEA COR to dispense a controlled substance is currently suspended or revoked or is surrendered in response to an order to show cause.  42 C.F.R. § 424.535(a)(13); 79 Fed. Reg. 29,844, 29,895-96 (May 23, 2014).  
4. Petitioner does not dispute that his DEA COR was revoked.  

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5. There is a basis for revocation of Petitioner’s enrollment in Medicare pursuant to 42 C.F.R. § 424.535(a)(13) based upon revocation of Petitioner’s DEA COR.  
6. If there is a basis for revocation of Petitioner’s Medicare enrollment, my jurisdiction does not extend to review of whether CMS properly exercised its discretion to revoke Petitioner’s Medicare enrollment and billing privileges.  
7. The effective date of revocation of Petitioner’s Medicare enrollment and billing privileges is July 13, 2022, 30 days after the date the initial determination was mailed to Petitioner.  42 C.F.R. § 424.535(g)(1).  
8. Petitioner does not dispute that CMS has discretion to impose a reenrollment bar for up to 10 years, and I have no authority to review CMS’s determination to impose a five-year bar to Petitioner’s reenrollment in Medicare.  
9. The five-year bar to reenrollment began on July 13, 2022, 30 days after the date on which the MAC mailed the notice of revocation to Petitioner.  42 C.F.R. § 424.535(c)(1).  
10. Petitioner does not dispute that CMS has discretion to place an individual’s name on the Preclusion List.  
11. There is a legitimate basis to place Petitioner’s name on the CMS Preclusion List pursuant to 42 C.F.R. §§ 422.2, 423.100, based on revocation of Petitioner’s Medicare enrollment, the reenrollment bar, and the CMS determination that Petitioner’s conduct underlying his revocation was detrimental to the Medicare program.  
    1. Revocation of Petitioner’s DEA COR

On March 2, 2020, a former Acting Administrator of the DEA issued an order to show cause (OSC) and immediately suspended Petitioner’s DEA COR.  The OSC informed Respondent of the immediate suspension of his DEA COR and proposed its revocation, the denial of any pending applications for renewal or modification of such registration, and the denial of any pending applications for additional DEA registrations, finding that Petitioner’s “continued registration is inconsistent with the public interest.”  Petitioner requested a hearing concerning the revocation of his COR, which was held on July 21 and 22, 2020.  The DEA Chief ALJ issued recommended rulings, findings of fact, conclusions of law, and a recommended decision on August 20, 2020.  On September 20, 2021, the Administrator published a decision and order in the Federal Register.  

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The decision and order revoked Petitioner’s DEA COR, then further denied any pending applications to renew or modify his registration and any other pending applications for registration in Virginia effective October 20, 2021.  CMS Ex. 8 at 1; RFH at 1-2; RFH Ex. D at 28-29 (document page counter). 

2. Analysis

I conclude that CMS has made a prima facie showing of a basis for revocation of Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(13)(i) because Petitioner’s DEA COR was revoked.  I further conclude that Petitioner has failed to rebut the CMS prima facie case or establish any affirmative defense. 

CMS made a prima facie showing of a basis for revocation of Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(13)(i) based on the evidence and Petitioner’s admission (RFH at 4) that the DEA revoked his COR effective October 20, 2021.  Therefore, CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(13)(i). 

Although Petitioner does not dispute the revocation of his DEA COR, he argues revocation of his Medicare enrollment and billing privileges is inappropriate because the DEA hearing and appeals process took years to complete, and the MAC revoked Petitioner’s enrollment nearly two and one-half years after the original DEA Order to Show Cause and immediate suspension occurred.  Petitioner also argues that the DEA did not permanently revoke his DEA COR, and Petitioner has reapplied for a new DEA COR.  RFH at 4-5. 

Petitioner’s efforts to obtain a new DEA COR have no effect on CMS’s authority to revoke Petitioner’s Medicare enrollment.  When promulgating 42 C.F.R. § 424.535(a)(13), the Secretary made it clear that the DEA’s decision to revoke a DEA COR would impact a physician’s status in the Medicare program.  The Secretary stated that “the loss of the ability to prescribe drugs via a suspension or revocation of a DEA COR or by state action is a clear indicator that a physician or eligible professional may be misusing or abusing his or her authority to prescribe such substances” and that “we are concerned that a physician or eligible professional’s improper prescribing practices may be duplicated in the Medicare program.”  79 Fed. Reg. at 29,896.  Further, when answering whether a physician could reenroll in the Medicare program once the DEA lifted its revocation of a COR, the Secretary responded that the physician could seek enrollment again “upon the expiration of his or her reenrollment bar.”  79 Fed. Reg. at 29,897.  Therefore, Petitioner’s efforts to obtain a new DEA COR, are not relevant.  Only if Petitioner obtains a new DEA COR in the future may he reapply for enrollment in Medicare after his bar to reenrollment expires.  When the DEA Administrator’s order became effective on October 20, 2021, CMS had a basis for revocation of Petitioner’s

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Medicare enrollment and billing privileges.  If Petitioner is issued a DEA COR in the future, the Secretary has indicated that Petitioner may reapply for Medicare enrollment, but only after his bar to reenrollment expires, after about July 12, 2027. 

Under 42 C.F.R. § 424.535(a), CMS has discretion not to revoke.  However, I have no authority to review the exercise of discretion to revoke when I find there is a basis for revocation.  George M. Young, M.D., DAB No. 2750 at 11 (2016); Ahmed, DAB No. 2261 at 19.  To the extent Petitioner’s arguments constitute requests for equitable relief, I have no authority to substitute my judgment for that of CMS and void the revocation based on equitable considerations.  US Ultrasound, DAB No. 2302 at 8 (2010).  Furthermore, I am 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). 

Under 42 C.F.R. § 424.535(g)(1), the effective date of Petitioner’s revocation is 30 days after the date the MAC mailed Petitioner the initial determination to revoke.  The initial determination was dated July 13, 2022, and no issue has been raised about whether that was the date of mailing.  CMS Ex. 3 at 1.  Therefore, the effective date of revocation is July 13, 2022.⁵ 42 C.F.R. § 424.535(g)(1). 

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I have no authority to review the duration of five-year reenrollment bar imposed on Petitioner.  The duration of a bar to reenrollment imposed by CMS is not subject to review by an ALJ or the Board.  Heidy Woody, NP, DAB No. 3102 at 19-21 (2013).   When 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).  In this case, CMS determined that a five-year reenrollment bar was appropriate.  Petitioner argues that CMS abused its discretion in imposing a five-year reenrollment bar.  RFH at 5-6.  There is no statutory or regulatory language establishing a right to review of the duration of the reenrollment bar CMS imposes, or when it commences or ends.  Act § 1866(j)(8); 42 C.F.R. §§ 424.535(c), 424.545, 498.3(b), 498.5.  The Board has held that the duration of a revoked supplier’s reenrollment bar is not an appealable initial determination listed in 42 C.F.R. § 498.3(b) and is not subject to ALJ review.  Vijendra Dave, M.D., DAB No. 2672 at 11 (2016). 

Finally, because I have found that there is a basis for revocation, and Petitioner is subject to a reenrollment bar, CMS has a basis for adding Petitioner’s name to the CMS preclusion list for the duration of his reenrollment bar.  The CMS hearing officer on reconsideration addressed in detail the basis for placing Petitioner’s name on the CMS preclusion list and Petitioner’s challenges to that action.  CMS Ex. 1 at 4-6.⁶ I have no authority to review CMS’s exercise of discretion in determining that Petitioner’s underlying conduct was detrimental to Medicare and in adding Petitioner’s name to the preclusion list where, as here, I determine that there is a basis for such action.  42 C.F.R. §§ 422.2, 423.100 (definition of preclusion list); 83 Fed. Reg. at 16,641-67. 

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Petitioner argues revoking his Medicare enrollment and billing privileges will negatively impact his practice area, which has been designated a primary care Health Professional Shortage Area and a low income Medically Underserved Population.  RFH at 5.  Petitioner’s request for hearing urges CMS to consider the community impact of revoking Petitioner’s Medicare enrollment and billing privileges. 

To the extent Petitioner’s arguments about providing health care in a severely under-resourced are an effort to demonstrate “that exceptional circumstances exist regarding beneficiary access to items, services, or drugs” within the meaning of 42 C.F.R. § 422.222(a)(6), the determination of exceptional circumstances falls within CMS’s discretion, and I have no authority to overturn a lawful revocation based on weighing these interests: 

“[W]hen reviewing a Medicare enrollment revocation, the Board and its ALJs are limited to deciding whether the regulatory prerequisites for revocation have been satisfied.” Donohue, DAB No. 2888, at 10.  Because we conclude that the regulatory elements in section 424.535(a)(4) are met in this case, “we must sustain the revocation . . .  regardless of other factors” (such as the needs of the community served by Dr.  Garner) “that CMS might reasonably have weighed in exercising its discretion about whether or not to revoke.” Id. (internal quotation marks omitted); see alsoDaniel Wiltz, M.D., et al., DAB No. 2864, at 12 (2018) (“If, as here, CMS has a basis for revocation, the Board must uphold the determination to revoke without regard to, e.g., . . .  the potential impact of revocation on the supplier’s 
patients . . . .”); Dinesh Patel, M.D., DAB No. 2551, at 10 (2013) (holding that the Board had no authority to overturn a revocation based on Medicare beneficiaries’ need for the revoked physician’s services). 

William Garner, M.D., DAB No. 3026 at 16 (2020). 

I conclude that I have no authority to review whether CMS fulfilled its legal obligation to conduct the required analysis and determined that exceptional circumstances did not justify excepting Petitioner from placing of his name on CMS’s Preclusion List.  See, e.g., Brian K. Ellefsen, DAB No. 2626 at 7 (2015) (citing U.S. Postal Serv. v. Gregory, 534 U.S. 1, 10 (2001) (“a presumption of regularity attaches to the actions of Government agencies”); U.S. v. Chemical Found., Inc., 272 U.S. 1, 1415 (1926) (stating that the “presumption of regularity supports the official acts of public officers,” so “in the absence of clear evidence to the contrary, courts presume that they have properly discharged their official duties”)).  CMS’s exercise of its discretion in placing Petitioner’s

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name on the CMS Preclusion List, even if there are beneficiary access issues is not reviewable by me.

III. Conclusion

For the foregoing reasons, Petitioner’s Medicare enrollment and billing privileges are revoked pursuant to 42 C.F.R. § 424.535(a)(13), effective July 13, 2022.  There is a basis for listing Petitioner on the CMS preclusion list for the duration of his five-year bar to reenrollment. 

Endnotes

¹ Citations are to the 2021 revision of the Code of Federal Regulations (C.F.R.), which was in effect at the time of the initial determination, unless otherwise indicated.  An appellate panel of the Departmental Appeals Board (Board) concluded in Mark A.  Kabat, D.O., DAB No. 2875 at 9-11 (2018) that the applicable regulations are those in effect at the time of the initial determination.  The Board previously concluded that the only determination subject to my review in a provider and supplier enrollment case such as this is the reconsidered determination.  Neb Group of Ariz.  LLC, DAB No. 2573 at 7 (2014).  In this case, the applicable regulations did not change between the issuance of the initial and reconsidered determinations. 

² Some of Petitioner’s exhibits duplicate the exhibits filed by CMS.  Generally, I cite to the CMS exhibit rather than the duplicate filed by Petitioner. 

³ A “supplier” furnishes services under Medicare and includes 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) (42 U.S.C. § 1395f(g)) and 1835(e) (42 U.S.C. § 1395n(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.

⁴ “Credible evidence” is evidence that is worthy of belief.  Black’s Law Dictionary 596 (8th ed.  2004).  The “weight of evidence” is the persuasiveness of some evidence compared to other evidence.  Id. at 1625. 

⁵ It is arguable that a DEA COR is akin to a license and, therefore, the effective date of revocation should be October 21, 2021, the date the DEA COR was revoked.  The regulation in effect at the time of the initial determination provided: 

(g) Effective date of revocation. Revocation becomes effective 30 days after CMS or the CMS contractor mails notice of its determination to the provider or supplier, except if the revocation is based on Federal exclusion or debarment, felony conviction, license suspension or revocation, or the practice location is determined by CMS or its contractor not to be operational.  When a revocation is based on a Federal exclusion or debarment, felony conviction, license suspension or revocation, or the practice location is determined by CMS or its contractor not to be operational, the revocation is effective with the date of exclusion or debarment, felony conviction, license suspension or revocation or the date that CMS or its contractor determined that the provider or supplier was no longer operational.  42 C.F.R. § 424.535(g) (italics in original, bold added).  However, the DEA does not refer to the DEA COR as a license, and CMS elected not to treat the DEA COR as a license in this case.  21 C.F.R. § 1301.11-.13; CMS Ex. 1. Furthermore, the Board has not treated the DEA COR as a license for purposes of determining the effective date of revocation under 42 C.F.R. § 424.535(a)(13) and (g).  John O. Dimowo, MD, DAB No. 3101 (2023).  I also note that, depending on the number of claims submitted by or on behalf of Petitioner and paid by Medicare during the period October 21, 2021 through and July 13, 2022, the later effective date probably benefits Petitioner. 

⁶ The hearing officer appears to have reviewed the DEA Administrator’s imminent danger analysis discussed above in determining that Petitioner demonstrated a propensity for negligent, dangerous, and non-compliant behavior, as well as a complete disregard for state and federal government rules and regulations.  CMS Ex. 1 at 4-6.