David Betat, MD, DAB CR6613 (2025)

DECISION

Petitioner’s Medicare enrollment and billing privileges are revoked pursuant to 42 C.F.R. § 424.535(a)(13),1 effective December 2, 2023.  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.

Page 2

I. Background

On November 2, 2023, Noridian Healthcare Solutions (Noridian), a Medicare administrative contractor (MAC), notified Petitioner of its initial determination to revoke his Medicare enrollment and billing privileges effective December 2, 2023, 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 12.

Petitioner requested reconsideration on November 14, 2023.  CMS Ex. 1 at 9-10.  On March 4, 2024, a CMS hearing officer issued a reconsidered determination upholding revocation under 42 C.F.R. § 424.535(a)(13), Petitioner’s five-year reenrollment bar, and listing Petitioner’s name on CMS’s preclusion list.  CMS Ex. 1 at 1-8.

On March 13, 2024, Petitioner timely filed a request for hearing (RFH) before an administrative law judge (ALJ).  The case was assigned to me on March 13, 2024, and my Standing Order was issued.

On April 11, 2024, CMS filed a combined prehearing brief and motion for summary judgment (CMS Br.), exhibit and witness lists, and CMS Exs. 1 and 2.  No objections have been made to my consideration of CMS Exs. 1 and 2, which are admitted and considered as evidence.

On May 28, 2024, Petitioner filed his brief (P. Br.) and a six-page document that I treat as Petitioner’s exhibit (P. Ex.) 1.2

Petitioner also submitted documents with his request for hearing.3  Citing 42 C.F.R. § 498.56(e), CMS objects to my consideration of the documents Petitioner filed with his request for hearing.  CMS argues that the documents were not submitted at reconsideration and Petitioner has not stated good cause for failure to file the documents before the CMS hearing officer.  CMS Br. at 11-12; Standing Order ¶¶ D.2., E.  Petitioner was advised that a showing of good cause must be made to present evidence not previously considered in the reconsidered determination.  Standing Order ¶¶ D.2., E.  The supporting documents were not presented during the reconsideration process.  CMS Ex. 1 at 2.  And Petitioner has failed to show good cause why the documents are being presented for the first time before me.  DAB E-File ## 1a, 2, 2a-f are the pages of the

Page 3

March 4, 2024 reconsidered determination that is already in evidence as CMS Ex. 1 at 1 through 7 and there is no need to admit cumulative evidence.  DAB E-File ## 1b-d, 3, and 3a-b are documents that are related to prescribing opioids.  No issue related to prescribing opioids is before me for decision and the documents are irrelevant and must also be excluded for that reason.  Pursuant to 42 C.F.R. § 498.60(b)(1), I am to receive as evidence any evidence that is relevant and material to the issues before me.  Relevant evidence is any evidence that has a tendency to make a fact of consequence to the issue I may decide more or less probable than without the evidence.  Fed. R. Evid. 401.  Therefore, the supporting documents filed with the request for hearing are not admitted as evidence.

On June 3, 2024, CMS waived filing a reply to Petitioner’s brief.  Therefore, CMS did not object to my consideration of P. Ex. 1.  However, I must exclude any new documentary evidence offered by Petitioner, if I determine that Petitioner does not have good cause for failing to previously present such evidence.  42 C.F.R. § 498.56(e); Standing Order ¶¶ D.2, E.  P. Ex. 1 is a six-page document that includes:  (1) a January 3, 2024 email from a monitoring company; (2) a January 29, 2024 email from Tang Consulting; (3) a January 8, 2024 letter from the Medical Board of California notifying Petitioner of the successful completion of his medical license probation; 4) a May 15, 2019 letter from Petitioner to Livanta discussing  the cases of several patients for whom Petitioner prescribed opioids; and (5) an unsigned letter from Petitioner’s attorney dated September 4, 2019.  These documents are new evidence within the meaning of 42 C.F.R. § 498.56(e)(1) because they existed at the time of the reconsidered determination but were not presented to the CMS hearing officer to consider. 4  CMS Ex. 1 at 2.  Petitioner has not stated good cause for the submission of this new evidence to me for the first time.  CMS Ex. 1 at 2.  Therefore, I must exclude P. Ex. 1 from evidence.  The documents included in P. Ex. 1 must also be excluded because they are not relevant to the issues I must decide, i.e., whether CMS had a basis to revoke Petitioner’s Medicare enrollment and place his name on the CMS preclusion list.  The actions of the MAC and CMS are based on Petitioner’s loss of his Drug Enforcement Administration (DEA) Certificate of Registration [COR], and nothing in P. Ex. 1 rebuts or otherwise creates a dispute about whether Petitioner lost his DEA COR.  Furthermore, I accept as true for purposes of summary judgment that the Medical Board of California restored Petitioner’s license, though this fact is not relevant to my decision.

Page 4

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 the reasons listed in 42 C.F.R. § 424.535.  Pursuant to 42 C.F.R. § 424.535(a)(13), CMS may revoke a physician’s Medicare enrollment and billing privileges if the physician’s [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).

Page 5

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

Page 6

(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.

42 C.F.R. § 422.2.  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,” and “(3)” does not appear in the text.  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

Page 7

the right to ALJ review and appeal pursuant to 42 C.F.R. Part 498.  42 C.F.R. §§ 422.222(a)(2); 423.120(c)(6)(v).

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. Part 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. Part 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 and adding Petitioner’s name to the preclusion list.  “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 decisions to revoke Petitioner’s Medicare participation and billing privileges and to add Petitioner’s name to the preclusion list is legally sufficient under the Act and regulations.  CMS makes a prima facie showing of a basis for its action 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).

Page 8

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.

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. Part 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. Part 498.  See, e.g., Ill. Knights Templar Home, DAB No. 2274 at

Page 9

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 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 a 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. Part 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. Part 498.  Batavia Nursing & Conv. Ctr., DAB No. 1904.

Page 10

Viewing the evidence before me in a light most favorable to Petitioner and drawing all inferences in Petitioner’s favor, I conclude 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 April 11, 2022, the DEA Administrator published an order in the Federal Register in which she revoked Petitioner’s DEA COR effective May 11, 2022.  CMS Ex. 1 at 15, 21; P. Br. at 2.

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.

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 December 2, 2023, 30 days after the date the MAC’s 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 December 2, 2023, 30 days after the date on which the MAC mailed the notice of revocation to Petitioner.  42 C.F.R. § 424.535(c)(1).

Page 11

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 and 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

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.

There is no dispute that on April 11, 2022, the DEA Administrator published a decision and order in the Federal Register revoking Petitioner’s DEA COR effective May 11, 2022, and denying any pending applications, pursuant to authority of 21 U.S.C. §§ 824(a) and 823(f).  CMS Ex. 1 at 15, 21; P. Br. at 2.

The Administrator found that Petitioner:

[R]epeatedly issued controlled substance prescriptions without a legitimate medical purpose, outside the usual course of professional practice in the State of California, and “in violation of the minimum standard of care that governs California physicians with respect to the use of controlled substances in pain management.”

CMS Ex. 1 at 16.  The Administrator explained she 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 beneath the standards of care in violation of state and federal law and outside the course of professional practice that posed imminent danger.  CMS Ex. 1 at 20-21.

The MAC issued its initial determination to revoke, to impose a five-year reenrollment bar, and to place Petitioner’s name on the preclusion list on November 2, 2023.  CMS Ex. 1 at 12-14.

Page 12

CMS issued the reconsidered determination upholding the MAC’s initial determination on March 4, 2024.  CMS Ex. 1 at 1-8.

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

Petitioner practiced in underserved communities providing care to complex patients who were chronic opiate users.

In August 2019, Petitioner’s attorney representing him before the DEA failed to address a DEA Order to Show Cause.

Petitioner chose not to file an appeal of his DEA COR revocation because of financial considerations and his belief that he could practice outpatient medicine without a DEA certificate.

Petitioner successfully completed a three-year period of probation imposed by the Medical Board of California that resulted in the full restoration of his medical license.

P. Br. at 2-3.  But these facts are not material to this decision.

b. Analysis

BASIS FOR REVOCATION

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 May 11, 2022 (CMS Ex. 1 at 21; P. Br. at 2), 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’S ARGUMENTS

Petitioner advances several arguments all of which must be resolved against him as matters of law.

Page 13

Petitioner argues that the DEA COR matter was mishandled by his attorney at the time who failed to timely respond to a DEA order to show cause, and that he did not appeal the revocation due to financial considerations, and his belief that he would be able to practice outpatient medicine without a DEA COR.  P. Br. at 2; RFH at 2.  Petitioner’s counsel’s failings are a matter between him and his counsel and have no effect on CMS’s authority to revoke Petitioner’s Medicare enrollment.  Petitioner’s choice not to pursue his DEA COR revocation further, also has no impact on the CMS authority to revoke his Medicare enrollment and billing privileges.

Petitioner argues that revoking his Medicare enrollment and billing privileges will adversely impact his practice area, which has been designated a primary care Health Professional Shortage Area and a low income Medically Underserved Area.  Petitioner disagrees with the CMS exercise of discretion to revoke in his case.  He points out that after he regained his California license, he has effectively delivered care even though he has no DEA COR, by simply referring patients who need prescriptions to other physicians.  RFH at 1-2.  Petitioner is correct that CMS had discretion under 42 C.F.R. § 424.535(a) not to revoke his Medicare enrollment and billing privileges.  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.  While the Secretary and CMS may have authority not to revoke Petitioner’s Medicare enrollment and billing privileges due to a continuing need for his services even though he has no DEA COR, that decision is not subject to my review.  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).

Petitioner’s arguments may also be construed to seek equitable relief.  But when I determine as I have here that CMS had a basis for revocation, I have no authority to substitute my judgment for that of CMS and void the revocation based on equitable considerations or provide any other equitable relief.  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).

EFFECTIVE DATE OF REVOCATION

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 November 2, 2023, and no issue has been raised about whether that was the date of mailing.  CMS Ex. 1 at 12.  The effective date of revocation of

Page 14

Petitioner’s Medicare enrollment and billing privileges is December 2, 2023, 30 days after the date on which the MAC’s initial determination was mailed to Petitioner.6  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.  CMS Ex. 1 at 5-6, 12.  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 repeatedly held that the duration of a revoked supplier’s reenrollment bar is not subject to review by an ALJ or the Board.  Frank B. Lee, M.D., DAB No. 3170 at 2, 32-33 (2025).

Page 15

PRECLUSION LIST

The regulations defining preclusion list establish three independent grounds for placing an individual, entity, or prescriber on CMS’s preclusion list.  The second ground pertains to individuals not enrolled in Medicare and not subject to revocation of Medicare enrollment and billing privileges.  42 C.F.R. § 422.2 (preclusion list (2)).  The third ground applies to any individual, entity or prescriber convicted of a felony that is detrimental to Medicare.  42 C.F.R. § 422.2 (preclusion list (3)).  The second and third grounds do not apply in this case.  The first ground is applicable in Petitioner’s case.  The name of an individual, entity, or prescriber on the preclusion list person when they:

(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.

42 C.F.R. §§ 422.2; 423.100

The MAC revoked Petitioner’s enrollment in Medicare pursuant to 42 C.F.R. § 424.535(a)(13) effective December 2, 2022, based on the revocation of his DEA COR.  The MAC imposed a five-year bar to reenrollment when it revoked Petitioner’s Medicare enrollment.  The MAC and CMS determined that Petitioner’s name would be added to

Page 16

the preclusion list based on the revocation and reenrollment bar.  CMS Ex. 1 at 1-8, 12-14.  Therefore, the first two criteria for adding Petitioner’s name to the preclusion list are satisfied.  The third criteria is also satisfied because CMS determined that the underlying conduct that led to his revocation is detrimental to the Medicare program’s best interests.  
The CMS hearing officer described her consideration of the regulatory factors in detail in the reconsidered determination.  The CMS hearing officer determined Petitioner’s underlying conduct to be detrimental to the best interests of Medicare based on the seriousness of Petitioner’s conduct that resulted in the DEA COR revocation and the threat to the integrity of the Medicare program posed by Petitioner’s inappropriate prescribing.  The hearing officer noted that CMS established the preclusion list to reduce “the amount of opioids that are improperly or unnecessarily prescribed by persons who pose a heightened risk to the Part D program and Medicare beneficiaries.”  CMS Ex. 1 at 4-5 (citing 82 Fed. Reg. 56,336, 56,444 (Nov. 28, 2017)).  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.  83 Fed. Reg. 16,440, 16,641-67.  If I could reweigh the factors and substitute my discretion for that of CMS, I would not arrive at a different result.  The bases cited by the DEA Administrator for revoking Petitioner’s DEA COR show the seriousness of Petitioner’s conduct, the adverse impact his conduct had upon the integrity of the Medicare program, and that his conduct was the kind of conduct for which the preclusion listed was created to protect the Medicare program and its beneficiaries.

Petitioner’s arguments about providing health care in a severely under-resourced area may be viewed as an attempt to demonstrate “that exceptional circumstances exist regarding beneficiary access to items, services, or drugs.”  42 C.F.R. § 422.222(a)(6).  However, the regulation is very specific that “CMS has the discretion not to include a particular individual” on the preclusion list if it determines that there are exceptional circumstances.  42 C.F.R. § 422.222(a)(6).  There is no regulatory provision for ALJ or Board review of the CMS determination not to include a name on the preclusion list due to exceptional circumstances.

An individual’s, entity’s, or prescriber’s name is added to the preclusion list after the 60‑day period for requesting reconsideration of the initial determination has expired or the date of a reconsidered determination if reconsideration is requested.  42 C.F.R. §§ 422.222(a)(3)(ii), 423.120(c)(6)(v)(C).  Petitioner requested reconsideration.  The reconsidered determination was issued on March 4, 2024.  Therefore, Petitioner’s name may be added to the CMS preclusion list on March 4, 2024.

Generally, an individual’s or entity’s name is included on the preclusion list for the same period as the individual or entity is subject to a reenrollment bar.  42 C.F.R. §§ 422.222(a)(5)(i), 423.120(c)(6)(vii)(A).  Petitioner’s five-year reenrollment bar, which

Page 17

began 30 days after mailing of the November 2, 2023 initial determination, expires December 2, 2028.  42 C.F.R. § 424.535(c)(1)(i).

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 December 2, 2023.  Petitioner’s five-year reenrollment bar runs from December 2, 2023 through December 2, 2028.  There is a basis for listing Petitioner’s name on CMS’s preclusion list from March 4, 2024 through December 2, 2028.