John Xiao-Jiang Qian, MD, DAB CR6494 (2024)

DECISION

Petitioner’s Medicare enrollment and billing privileges are revoked pursuant to 42 C.F.R. § 424.535(a)(13),¹ effective July 22, 2022.  There is a basis for listing Petitioner’s name

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on the Centers for Medicare & Medicaid Services (CMS) Preclusion List for the duration of his² five-year reenrollment bar. 

I.     Background

On June 22, 2022, Noridian Healthcare Solutions (Noridian), a Medicare administrative contractor (MAC) notified Petitioner of its initial determination to revoke Petitioner’s Medicare enrollment and billing privileges effective July 22, 2022, to impose a five-year reenrollment bar, and to list Petitioner’s name on CMS’s Preclusion List.  The MAC cited 42 C.F.R. § 424.535(a)(13) as authority for the revocation.  CMS Exhibit (Ex.) 1 at 10. 

Petitioner requested reconsideration.  CMS Ex. 1 at 13-17.  A CMS hearing officer issued a reconsidered determination on October 13, 2022, upholding revocation under 42 C.F.R. § 424.535(a)(13), Petitioner’s reenrollment bar, and listing Petitioner’s name on CMS’s Preclusion List.  CMS Ex. 1 at 1-9. 

On December 7, 2022, Petitioner timely requested a hearing before an administrative law judge (ALJ).  The case was assigned to me on December 8, 2022, and my Standing Order was issued. 

On January 6, 2023, CMS filed a combined prehearing brief and motion for summary judgment (CMS Br.), exhibit and witness lists, and CMS Ex. 1.  On February 6, 2023, Petitioner filed a prehearing brief and opposition to CMS’s motion for summary judgment (P. Br.), exhibit and witness lists, but no exhibits.³  On February 21, 2023, CMS filed a reply (CMS Reply). 

No objections have been made to my consideration of CMS Ex. 1, which is admitted and considered as evidence.⁴ 

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II.     Discussion

A. 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. ⁵  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

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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. 

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.  

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(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

(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.  

(ii) CMS determines that the underlying conduct that would have led to the revocation is detrimental to the best interests of the Medicare program.  In making this determination under this paragraph (2)(ii), CMS considers the following factors:  

(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.  

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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 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 CMS’s 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)(i) 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’s name 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’s enrollment in Medicare is currently revoked 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).  

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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 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’s name to CMS’s 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)). 

B.  Issues

Whether there is 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 add Petitioner’s name to CMS’s Preclusion List. 

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

My conclusions of law are set forth in bold followed by the undisputed facts and analysis. 

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1.  Summary judgment is appropriate.

A supplier 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, 373 F.3d at 748-51.  A party may waive appearance at an oral hearing but must do so affirmatively in writing.  42 C.F.R. § 498.66(a).  In this case, CMS filed a motion for summary judgment, and Petitioner filed a brief in opposition.  However, Petitioner has not waived the right to oral hearing or otherwise consented to a decision based only upon the documentary evidence or pleadings.  Accordingly, disposition on the written record alone is not permissible, unless the motion for summary judgment has merit. 

Summary judgment is not automatic upon request but is limited to certain specific conditions.  The Secretary’s regulations that establish the procedure to be followed in adjudicating Petitioner’s case are at 42 C.F.R. pt. 498.  42 C.F.R. §§ 405.800; 405.803(a); 424.545(a); 498.3(b)(17), (20).  The regulations do not establish a summary judgment procedure or recognize such a procedure.  However, the Board has long accepted that summary judgment is an acceptable procedural device in cases adjudicated pursuant to 42 C.F.R. pt. 498.  See, e.g., Ill. Knights Templar Home, DAB No. 2274 at 3-4 (2009); Garden City Med. Clinic, DAB No. 1763 (2001); Everett Rehab. & Med. Ctr., DAB No. 1628 at 3 (1997).  The Board also has recognized that the Federal Rules of Civil Procedure (Fed. R. Civ. P.) do not apply in administrative adjudications such as this.  However, the Board has accepted that Fed. R. Civ. P. Rule 56 and related cases provide useful guidance for determining whether summary judgment is appropriate.  Furthermore, a summary judgment procedure was adopted as a matter of judicial economy within my authority to regulate the course of proceedings and made available to the parties in the litigation of this case by my Standing Order.  The parties were given notice by the Standing Order that summary judgment is an available procedural device and that the law as it has developed related to Fed. R. Civ. P. Rule 56 will be applied.  Standing Order ¶¶ D, G. 

Summary judgment is appropriate when there is no genuine dispute as to any issue of material fact for adjudication and/or the moving party is entitled to judgment as a matter of law.  The party requesting summary judgment bears the burden of showing that there are no genuine issues of material fact for trial and/or that it is entitled to judgment as a matter of law.  In determining whether there are genuine issues of material fact for trial, the reviewer must view the evidence in the light most favorable to the non-moving party, drawing all reasonable inferences in that party’s favor.  Generally, the non-movant may not defeat an adequately supported summary judgment motion by relying upon the denials in its pleadings or briefs but must furnish evidence of a dispute concerning a material fact, i.e., a fact that, if proven, would affect the outcome of the case. Mission 

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Hosp. Reg’l Med. Ctr., DAB No. 2459 at 4 (2012) (and cases cited therein); Experts Are Us, Inc., DAB No. 2452 at 4 (2012) (and cases cited therein); Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 3 (2010) (and cases cited therein); see also Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).  

The standard for deciding a case on summary judgment and an ALJ’s decision-making in deciding a summary judgment motion differs from that used in resolving a case on the merits after a hearing or when hearing is waived.  On summary judgment, the ALJ does not make credibility determinations, weigh the evidence, or decide which inferences to draw from the evidence, as would be done when finding facts after a hearing on the record.  Rather, on summary judgment, the ALJ construes the evidence in a light most favorable to the non-movant and avoids deciding which version of the facts is more likely true.  Holy Cross Vill. at Notre Dame, Inc., DAB No. 2291 at 5 (2009).  The Board also has recognized that on summary judgment it is appropriate for the ALJ to consider whether a rational trier of fact could find that the party’s evidence would be sufficient to meet that party’s evidentiary burden.  Dumas Nursing & Rehab., L.P., DAB No. 2347 at 5 (2010).  The Secretary has not provided in 42 C.F.R. pt. 498 for the allocation of the burden of persuasion or the quantum of evidence required to satisfy the burden.  However, the Board has provided some persuasive analysis regarding the allocation of the burden of persuasion in cases subject to 42 C.F.R. pt. 498.  Batavia Nursing & Conv. Ctr., DAB No. 1904 (2004), aff’d, 129 Fed. App’x 181 (6th Cir. 2005). 

Viewing the evidence before me in a light most favorable to Petitioner and drawing all inferences in Petitioner’s favor, I conclude as discussed in the following analysis that there are no genuine disputes as to any material facts pertinent to revocation under 42 C.F.R. § 424.535(a)(13) or adding Petitioner’s name to CMS’s Preclusion List that require a hearing in this case.  CMS is entitled to judgment as a matter of law.  Accordingly, summary judgment is appropriate. 

2.  On February 11, 2022, the DEA Administrator published an order in the Federal Register in which she revoked Petitioner’s DEA COR effective March 14, 2022. 

3.  The Secretary has determined and provided by regulation that CMS may revoke the Medicare enrollment of a supplier if their 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)(i); 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 the revocation of Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(13)(i). 

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 22, 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 22, 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. 

a.  Undisputed Facts:  Revocation of Petitioner’s DEA COR

The parties were advised in the Standing Order ¶ G that, for purposes of ruling on a motion for summary judgment, a fact alleged and not specifically denied would be accepted as true and offered evidence would be considered admissible and true absent a specific objection.  The following findings of fact are based upon the undisputed or conceded facts.  I do not make credibility determinations, weigh the evidence, or decide which inferences to draw from the evidence in deciding a summary judgment motion.  The evidence is viewed in the light most favorable to Petitioner, the nonmovant, with all inferences drawn in Petitioner’s favor. 

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There is no dispute that on February 11, 2022, the DEA Administrator published a decision and order in the Federal Register revoking Petitioner’s DEA CORs effective March 14, 2022, and denying any pending applications, pursuant to authority of 21 U.S.C. §§ 824(a) and 823(f).  CMS Ex. 1 at 134; P. Br. at 1-3.  The Administrator took the action, in part, because Petitioner’s registration was inconsistent with the public interest due to findings of multiple failures related to prescribing controlled substances that were violations of state and federal law and outside the course of professional practice that posed imminent danger.  CMS Ex. 1 at 115, 130-33. 

For purposes of summary judgment, I accept as true Petitioner’s assertions that: 

Petitioner has filed an appeal of his DEA COR revocation with the U.S. Court of Appeals for the Ninth Circuit; and

Petitioner has filed an application for a new DEA COR.  

P. Br. at 2, 7-8.  However, as explained in my analysis, neither fact is material to this decision. 

b.  Analysis

The Secretary has determined and provided by regulation that CMS may revoke the Medicare enrollment of a supplier whose DEA COR to dispense controlled substances “is currently suspended or revoked or is surrendered in response to an order to show cause.”  42 C.F.R. § 424.535(a)(13)(i); 79 Fed. Reg. 29,844, 29,895-96. 

I conclude that the undisputed fact that Petitioner’s DEA COR was revoked effective March 14, 2022 (CMS Ex. 1 at 134; P. Br. at 1-3), is a sufficient basis for revocation of Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(13)(i).  I further conclude that Petitioner has failed to aver facts that show there is a genuine dispute as to any fact material to revocation or sufficient to rebut the CMS prima facie case and CMS prevails as a matter of law.  

Petitioner advances several arguments all of which are unavailing. 

Petitioner argues that he should not have been revoked from Medicare because an appeal of his DEA COR revocation is pending before the U.S. Court of Appeals for the Ninth Circuit.  P. Br. at 1, 7-8, RFH.  Petitioner’s reasoning that his appeal of his DEA COR is not final because he has a pending appeal in the Ninth Circuit is faulty.  The plain language of 42 C.F.R. § 424.535(a)(13)(i) provides that it is the suspension or revocation of the DEA COR that is the basis for revocation of Medicare enrollment and billing privileges.  The regulation does not limit CMS’s discretion to revoke Medicare

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enrollment and billing privileges only after all appeals of the DEA COR revocation are exhausted and Petitioner points to no law establishing such a requirement. 

Petitioner argues that his DEA COR revocation was based on prescribing guidelines that are no longer in effect.  P. Br. at 8, RFH at 2.  Petitioner asserts that he has filed a new application for a DEA COR registration and expects to be issued a new certificate “in the near future.”  P. Br. at 7-8; RFH.  Petitioner does not allege that his conduct that was the basis for his DEA COR revocation would have been acceptable under current prescribing guidelines.  However, Petitioner asserts in his request for hearing that he would not have faced such a harsh penalty if the new guidelines were in effect at the time of the DEA action.  RFH at 3.  The reality is that the new guidelines were not in effect, the DEA Administrator acted when the old guidelines were in effect, and Petitioner’s argument is completely speculative. 

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 five-year bar to reenrollment expires.  When the DEA Administrator’s order became effective on March 14, 2022, CMS had a basis for revocation of Petitioner’s Medicare enrollment and billing privileges.  If Petitioner is issued a new DEA COR in the future, the Secretary has indicated that Petitioner may reapply for Medicare enrollment, but only after his reenrollment bar expires, which in this case is after about June 21, 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.  Additionally, to the extent Petitioner’s arguments seek 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

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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 June 22, 2022, and no issue has been raised about whether that was the date of mailing.  CMS Ex. 1 at 10.  The effective date of revocation of Petitioner’s Medicare enrollment and billing privileges is July 22, 2022, 30 days after the date on which the MAC’s initial determination was mailed to Petitioner.⁶ 

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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.  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 subject to review by an ALJ or the Board.  Heidy Woody, NP, DAB No. 3102 at 19-21 (2013); 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 CMS’s Preclusion List for the duration of his reenrollment bar, if the underlying conduct is determined to be detrimental to the best interest of Medicare.  Petitioner argues that I must determine whether CMS followed the regulatory criteria when it determined to add Petitioner’s name to the Preclusion List.  Petitioner concedes that the first two elements for adding Petitioner’s name to the Preclusion List under 42 C.F.R. §§ 422.2, Preclusion List (1)(i) and (ii) and 423.100 Preclusion List (1)(i) and (ii), are satisfied because his Medicare enrollment has been revoked and he is under a reenrollment bar.  P. Br. at 8.  However, Petitioner argues that CMS did not properly determine that the conduct underlying revocation of Petitioner’s DEA COR was detrimental to the best interests of the Medicare program based on the three factors established by the definitions of Preclusion List.  42 C.F.R. §§ 422.2, Preclusion List (1)(iii) and 423.100 Preclusion List (1)(iii).  P. Br. at 8-13.  Petitioner argues that CMS provided no explanation for how it weighed any mitigating factors.  P. Br. at 2-3; RFH at 2.  Petitioner’s approach is in error because he has not shown that CMS failed to consider a required factor from the definitions of Preclusion List.  Rather, he disputes how CMS considered or weighed the evidence related to the individual factors.  The CMS hearing officer described her consideration of the regulatory factors in detail in the reconsidered determination.  All the required factors are discussed.  CMS Ex. 1 at 6-7.  Petitioner disagrees with the CMS hearing officer’s analysis of the factors.  However, I have no authority to conduct review of 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; 83 Fed. Reg. 16,440, 16,641-67. 

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III.     Conclusion

For the foregoing reasons, the Medicare enrollment and billing privileges of Petitioner are revoked pursuant to 42 C.F.R. § 424.535(a)(13), effective July 22, 2022.  There is a basis for listing Petitioner’s name on CMS’s 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  The pronouns he, his, and him are used in this decision as Petitioner expressed no other preference.

³  Petitioner’s exhibit list includes only the October 13, 2022 CMS reconsidered determination described as being 341 pages.  In accordance with the Standing Order ¶ D.2, Petitioner correctly did not file a copy of the reconsidered determination, which would have duplicated CMS Ex. 1.

⁴  CMS filed an objection to my hearing the testimony of four witnesses listed on Petitioner’s witness list.  I note that CMS placed in evidence the written declarations of each of the four witnesses (CMS Ex. 1 at 23-29, 110-112), which are considered as evidence and accepted as true for purposes of summary judgment.  Standing Order ¶ G (fact alleged and not specifically denied may be accepted as true on summary judgment).  Because I conclude that summary judgment is appropriate in this case, no oral hearing will be convened at which the testimony of Petitioner’s proposed witnesses may be heard.

⁵  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.

⁶  It is arguable that a DEA COR is akin to a license and, therefore, the effective date of revocation should be March 14, 2022, 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 March 14, 2022, through and July 22, 2022, the later effective date probably benefits Petitioner.