Olga Wildfeuer, MD, DAB CR6648 (2025)

DECISION

The Medicare enrollment and billing privileges of Petitioner, Olga Wildfeuer, M.D., are revoked pursuant to 42 C.F.R. § 424.535(a)(13)(i),1 effective January 14, 2024.  There is a basis for listing Petitioner’s name on the Centers for Medicare & Medicaid Services (CMS) preclusion list during her one-year reenrollment bar. 

Page 2

I. Background

On December 15, 2023, National Government Services, a Medicare administrative contractor (MAC), notified Petitioner of its initial determination to revoke her Medicare enrollment and billing privileges effective January 14, 2024, to impose a one-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 by letter dated February 9, 2024.  CMS Ex. 1 at 16-21.  On July 5, 2024, a CMS hearing officer issued a reconsidered determination upholding revocation under 42 C.F.R. § 424.535(a)(13), Petitioner’s one-year reenrollment bar, and listing Petitioner’s name on CMS’s preclusion list.  CMS Ex. 1 at 1-9. 

On August 27, 2024, Petitioner timely filed a request for hearing before an administrative law judge (ALJ).  The case was assigned to me on August 28, 2024, and my Standing Order was issued. 

On September 27, 2024, CMS filed a combined prehearing brief and motion for summary judgment (CMS Br.) and CMS Exhibits 1 and 2.  No objections have been made to my consideration of CMS Exhibits 1 and 2, which are admitted and considered as evidence.  On October 17, 2024, Petitioner filed her brief (P. Br.) in opposition to the CMS motion for summary judgment with no exhibits.  On November 7, 2024, CMS waived the right to file a reply. 

II. Discussion

1. 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.2  Act §§ 1835(a) (42 U.S.C. § 1395n(a)), 1842(h)(1) (42 U.S.C. § 1395u(h)(1)).  

Page 3

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 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.”  42 C.F.R. § 424.535(a)(13)(i). 

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, 

Page 4

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
• (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 

Page 5

• 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 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, 

Page 6

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). 

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 is 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)). 

1. B. Issues

• Whether there is a basis for the revocation of Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(13); and
• Whether there is a basis to add Petitioner’s name to CMS’s preclusion list.

1. 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. 1. Summary judgment is appropriate.

CMS has requested summary judgment, and Petitioner opposes that motion. 

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 

Page 7

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 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. 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. 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 

Page 8

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 & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. 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 that there are no genuine disputes as to any material facts pertinent to revocation under 42 C.F.R. § 424.535(a)(13)(i) 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. 2. On August 14, 2023, the DEA published an order in the Federal Register in which the DEA Administrator revoked Petitioner’s DEA COR effective September 13, 2023. CMS Ex. 1 at 10-11; P. Br. at 6.
3. 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. 4. Petitioner does not dispute that her DEA COR was revoked.
5. 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. 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. 7. The effective date of revocation of Petitioner’s Medicare enrollment and billing privileges is January 14, 2024, 30 days after the date the 

Page 9

7. MAC’s initial determination was mailed to Petitioner. 42 C.F.R. § 424.535(g)(1).
8. 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 one-year bar to Petitioner’s reenrollment in Medicare.
9. 9. The one-year bar to reenrollment began on January 14, 2024, 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. 10. Petitioner does not dispute that CMS has discretion to place an individual’s name on the preclusion list.
11. 11. There is a 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 the conduct underlying Petitioner’s revocation was detrimental to the Medicare program.
    1. 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 non-movant, with all inferences drawn in Petitioner’s favor. 

There is no dispute that on August 14, 2023, the DEA published a decision and order in the Federal Register revoking Petitioner’s DEA COR effective September 13, 2023, and denying any pending applications, pursuant to authority of 21 U.S.C. §§ 824(a) and 823(g)(1).  CMS Ex. 1 at 10-11; P. Br. at 6.  The DEA Administrator accepted the entirety of an ALJ’s rulings, findings of fact, and conclusions of law on a motion for summary disposition by the government.  The DEA Administrator found Petitioner entered a consent agreement with the New York Board for Professional Medical Conduct (state board) that permanently limited Petitioner from ordering, prescribing administering, dispensing, or distributing controlled substances.  The DEA Administrator concluded that Petitioner was not authorized in New York, the state in which she was registered with the DEA, to order, prescribe, administer, dispense, or distribute controlled 

Page 10

substances.  The DEA Administrator did not cite facts underlying the consent agreement.  CMS Ex. 1 at 10-11. 

On December 15, 2023, the MAC issued its initial determination to revoke, to impose a one-year reenrollment bar, and to place Petitioner’s name on the CMS preclusion list.  The MAC cited 42 C.F.R. § 424.535(a)(13) as authority for the revocation based on the DEA Administrator’s revocation of Petitioner’s DEA COR.  The MAC did not cite to facts underlying Petitioner’s consent agreement.  CMS Ex. 1 at 12-14. 

On July 5, 2024, a CMS hearing officer issued the reconsidered determination upholding the MAC’s initial determination to revoke Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(13) effective January 14, 2024, the one-year reenrollment bar, and listing Petitioner’s name on the CMS preclusion list.  CMS Ex. 1 at 1-9.  The CMS hearing officer’s reconsidered determination shows that she considered Petitioner’s reconsideration request and multiple documents submitted by Petitioner with the request.  The reconsidered determination shows that the CMS hearing officer gleaned information regarding Petitioner’s consent agreement with the state board from documents submitted by Petitioner with her reconsideration request.  I draw this inference based on the language of the reconsidered determination (CMS Ex. 1 at 3-6), the fact the DEA Administrator’s order includes no such information about the facts underlying the consent agreement, and the MAC’s initial determination includes no information regarding Petitioner’s consent agreement with the state board or the basis for the agreement. 

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

• Petitioner has been continuously licensed to practice medicine in New York, with her only discipline related to the consent agreement with the state board.  P. Br. at 1.  
• Petitioner has devoted her life to serving and advocating for the medically needy, difficult to serve patients, with complex cases.  P. Br. at 1.  
• Petitioner agreed to the consent agreement with the state board to avoid the expense and uncertainty of a protracted administrative proceeding and to permit her to focus on caring for her patients.  P. Br. at 4.  
• Petitioner only admitted in the consent agreement to record keeping violations and she agreed not to prescribe controlled substances.  Her New York medical license was not suspended.  P. Br. at 4.  
• Petitioner’s participation in New York Medicaid was not affected by the consent agreement with the state board or, I infer, the underlying conduct.  P. Br. at 5.  

Page 11

1. 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. 

It is undisputed that Petitioner’s DEA COR was revoked effective September 13, 2023.  CMS Ex. 1 at 11; P. Br. at 6.  The revocation of Petitioner’s DEA COR 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, and CMS prevails as a matter of law.  

The gist of Petitioner’s arguments is that CMS erred in basing the decision to revoke Petitioner’s Medicare enrollment and billing privileges on the fact that Petitioner had entered the consent agreement with the state board.  P. Br. at 7 (CMS’ “determination was completely derivative of action taken by” the state board).  Indeed, Petitioner only refers in passing in her brief to the fact that her DEA COR was revoked by the DEA Administrator.  P. Br. at 6.  Petitioner errs in her focus because the revocation of her Medicare enrollment and billing privileges was based on the revocation of her DEA COR as authorized by 42 C.F.R. § 424.535(a)(13)(i) and not based on the existence of the consent agreement or Petitioner’s conduct that led to the consent agreement.  The MAC’s initial determination and the CMS hearing officer’s reconsidered determination clearly state that revocation was pursuant to 42 C.F.R. § 424.535(a)(13)(i) based on the DEA COR and no other reason.  In conducting her analysis, the CMS hearing officer did refer to conduct underlying the consent agreement that is not disputed by Petitioner.  I note that the evidence in the record regarding the conduct underlying the consent agreement and the reason for the agreement is evidence presented to the CMS hearing officer by Petitioner.  CMS Ex. 1 at 16-36.  I infer Petitioner admits the evidence she submitted is true and correct and undisputed based on its submission by her. 

Petitioner correctly notes CMS has discretion not to revoke under 42 C.F.R. § 424.535(a).  Petitioner argues that in deciding to revoke CMS: 

• Ignored that Petitioner has been permitted to continue to participate in the New York Medicaid program.  
• The state considered the need for Petitioner to continue to serve her patient population.  

Page 12

• Petitioner has maintained a clean professional license, and her acceptance of the consent agreement over a record-keeping violation does not change that fact.  
  The revocation of Petitioner’s Medicare enrollment and billing privileges defeats the state’s goal of allowing Petitioner to serve her patient population.  
• Petitioner harmed no patient or insurer.  
• CMS ignored that Petitioner had already successfully completed over two years of the three-year probation imposed by the state board.  

P. Br. at 8-9. Even if I accept all Petitioner’s assertions as true for purposes of summary judgment, I have no authority to review the exercise of discretion by CMS and the MAC 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; 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).  The revocation of Petitioner’s DEA COR is the basis for the revocation.  CMS and MAC considerations in proceeding to revoke when a basis for revocation exists are not subject to my review. 

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). 

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 December 15, 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 Petitioner’s Medicare enrollment and billing privileges is January 14, 2024, 30 days after the date on which the MAC’s initial determination was mailed to Petitioner.3 

Page 13

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 one-year reenrollment bar was appropriate.  CMS Ex. 1 at 5, 7, 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). 

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 

Page 14

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 may be added to the CMS preclusion list if 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 January 14, 2024, based on the revocation of her DEA COR.  The MAC imposed a one-year bar to reenrollment when it revoked Petitioner’s Medicare enrollment.  The MAC and CMS determined that Petitioner’s name would be added to the preclusion list based on the revocation and reenrollment bar.  CMS Ex. 1 at 1-9, 12-14.  Therefore, the first two criteria for adding Petitioner’s name to the preclusion list are satisfied.  The third criterion is also satisfied because CMS determined that the underlying conduct that led to her revocation is detrimental to the Medicare program’s best interests.  

Page 15

The CMS hearing officer described her consideration of the regulatory factors in the reconsidered determination.  The CMS hearing officer determined that the revocation of Petitioner’s DEA COR was serious.  The hearing officer considered that, as part of the consent agreement, Petitioner is permanently prohibited from ordering, prescribing, administering, distributing, and dispensing controlled substances and that was the basis for revocation of her DEA COR.  The hearing officer also considered that Petitioner admitted as part of her consent agreement that she failed to maintain accurate patient medical records for some patients.  The CMS hearing officer considered the failure to maintain accurate records was serious.  CMS Ex. 1 at 5-6.  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. 

Petitioner’s arguments about providing health care to her unique patient population 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 July 5, 2024.  Therefore, Petitioner’s name may be added to the CMS preclusion list on July 5, 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 one-year reenrollment bar, which began 30 days after mailing of the December 15, 2023 initial determination, expired January 14, 2025.  42 C.F.R. § 424.535(c)(1)(i). 

Page 16

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)(i) effective January 14, 2024.  Petitioner’s one-year reenrollment bar ran from January 14, 2024 through January 14, 2025.  There was a basis for listing Petitioner’s name on CMS’s preclusion list from July 5, 2024 through January 14, 2025.