Witold M. Zajewski, MD, DAB CR6168 (2022)

DECISION

The Centers for Medicare & Medicaid Services (CMS), through its Medicare administrative contractor, National Government Services (NGS), revoked the enrollment and billing privileges of Witold M. Zajewski, MD (Petitioner) pursuant to 42 C.F.R. § 424.535(a)(13) because Petitioner’s Drug Enforcement Authority (DEA) Certificate of Registration had been revoked.  CMS also placed Petitioner on its preclusion list.  42 C.F.R. §§ 422.2, 423.100.  Medicare Advantage (Part C) organizations and Part D prescription drug plan sponsors may not make any payment for health care items, services, or drugs that are furnished, ordered, or prescribed by an individual or entity included on the preclusion list.  42 C.F.R. §§ 422.222, 423.120(c)(6).

Petitioner appealed the revocation of his enrollment and billing privileges and his placement on CMS’s preclusion list.  As explained below, I conclude that CMS had a legal basis to revoke Petitioner’s Medicare enrollment and billing privileges and to place Petitioner on its preclusion list.

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I.    Case Background and Procedural History

Petitioner is a physician licensed in Illinois who participated in the Medicare program as a “supplier” of services.¹  CMS Exhibit (Ex.) 4 at 1.  By letter dated July 16, 2020, NGS informed Petitioner that, effective August 15, 2020, his Medicare enrollment and billing privileges were revoked and that he would be barred from reenrolling in Medicare for five years.  CMS Ex. 2 at 1, 3.  NGS further explained that the revocation was authorized under 42 C.F.R. § 424.535(a)(13) (Prescribing Authority) because Petitioner’s DEA Certificate of Registration had been revoked.  Id. at 1.  Finally, the letter informed Petitioner that he would be added to CMS’s preclusion list as well.  Id.

Petitioner requested reconsideration.  CMS Ex. 3.  By letter dated September 8, 2020, CMS’s Provider Enrollment & Oversight Group issued a reconsidered determination upholding NGS’s decisions to revoke Petitioner’s enrollment and billing privileges and to place Petitioner on the preclusion list.  CMS Ex. 1.

On November 2, 2020, Petitioner, through counsel, requested administrative law judge review of CMS’s reconsidered determination, and the case was assigned to me.  On November 4, 2020, my office acknowledged receipt of Petitioner’s hearing request and provided a copy of my Standing Prehearing Order (Prehearing Order).

In response to the Prehearing Order, CMS filed a prehearing brief, which incorporated a motion for summary judgment (CMS Br.), and 7 proposed exhibits (CMS Exs. 1‑7).  Petitioner filed a prehearing brief and opposition to CMS’s motion for summary judgment (P. Br.), as well as one proposed exhibit (P. Ex. 1).  Neither party has objected to the other party’s proposed exhibits.  Therefore, in the absence of objection, I admit CMS Exs. 1-7 into the record.  I decline to admit P. Ex. 1 because it duplicates parts of CMS Ex. 3.  Prehearing Order ¶ 4(c)(iii).

Neither side proposed any witnesses.  Accordingly, a hearing is not necessary, and I decide this case on the written record without considering whether the standard for summary judgment is met.  Prehearing Order ¶ 10.  I deny CMS’s motion for summary judgment as moot.

II.  Issues

The issues in this case are:

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Whether CMS had a legal basis to revoke Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(13); and

Whether CMS had a legal basis to place Petitioner on its preclusion list, as defined at 42 C.F.R. §§ 422.2 and 423.100.

III.  Jurisdiction

I have jurisdiction to hear and decide this case.  42 C.F.R. §§ 498.3(b)(17)(i) and (20), 498.5(l)(2) and (n)(2);² Social Security Act (Act) § 1866(j)(8) (codified at 42 U.S.C. § 1395cc(j)(8)).

IV.   Discussion

A.  Statutory and Regulatory Framework

As noted, Petitioner, a physician, participated in the Medicare program as a “supplier.”  Act § 1861(d) (codified at 42 U.S.C. § 1395x(d)); 42 C.F.R. §§ 400.202 (definition of supplier), 410.20 (definition of physician services).  To participate in the Medicare program as a supplier, an individual or entity must meet certain criteria to enroll and receive billing privileges.  42 C.F.R. §§ 424.505, 424.510.

CMS may revoke the enrollment and billing privileges of a supplier for any reason stated in 42 C.F.R. § 424.535(a).  After a supplier’s Medicare enrollment is revoked, the supplier is “barred from participating in the Medicare program from the effective date of the revocation until the end of the reenrollment bar.”  42 C.F.R. § 424.535(c)(1).  At the time of the initial determination in this case, the length of the reenrollment bar ranged from one to ten years.  42 C.F.R. § 424.535(c)(1).

Individuals and entities whose enrollment has been revoked and who are under a reenrollment bar may also, in certain circumstances, be placed on CMS’s preclusion list.  Medicare Advantage organizations and Medicare Part D plan sponsors may not provide reimbursement for any items or services furnished by an individual or entity on CMS’s preclusion list or for prescriptions that individuals write.  42 C.F.R.§§ 422.2, 422.222, 422.224, 423.100, 423.120(c)(6).

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

1. CMS had a legal basis to revoke Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(13) because Petitioner’s DEA Certificate of Registration was revoked.³

Under 42 C.F.R. § 424.535(a)(13), CMS may revoke a Medicare supplier’s enrollment and billing privileges if:  

(i) The physician or other eligible professional’s Drug Enforcement Administration (DEA) Certificate of Registration is suspended or revoked; or

(ii) The applicable licensing or administrative body for any state in which the physician or eligible professional practices suspends or revokes the physician or eligible professional’s ability to prescribe drugs.

Petitioner acknowledges that the Illinois Department of Financial and Professional Regulation (IDFPR) suspended his license to prescribe controlled substances, effective June 29, 2017.  CMS Ex. 6 at 3; P. Br. at 2-3.  IDFPR acted based on Petitioner’s “unprofessional conduct, nontherapeutic prescribing of controlled substances and violation of state and federal controlled substance regulations.”⁴  CMS Ex 6at 3.  IDFPR also announced that Petitioner’s license to prescribe controlled substances was suspended indefinitely (minimum 12 months), retroactive to the initial suspension date.  Id. at 2.

Similarly, Petitioner admits the DEA revoked his Certificate of Registration on April 4, 2018.  CMS Ex. 7 at 3; P. Br. at 2.  The DEA found that Petitioner was no longer authorized to dispense controlled substances in the state where he practices.  CMS Ex. 7 at 2.

Because Petitioner’s DEA registration was revoked, CMS had the authority to revoke Petitioner’s Medicare enrollment under 42 C.F.R. § 424.535(a)(13).

Petitioner represents that he satisfied the requirements IDFPR set when it suspended his Illinois controlled substances license.  P. Br. at 3.  On that basis, Petitioner filed a petition to restore his Illinois controlled substances license on August 30, 2018.  Id.  But, according to Petitioner, due to the COVID-19 pandemic and other “persistent delays,” Petitioner had still not received a decision on reinstatement as of the date of his brief.  Id.

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Had he been afforded a timely appeal, Petitioner maintains, he would have had an opportunity to restore his DEA registration.  Id.

I accept that, in attempting to restore his Illinois controlled substances license, Petitioner faced delays that were outside of his control.  But the fact remains that, at the time his Medicare enrollment was revoked, Petitioner’s Illinois controlled substances license was still suspended and his DEA registration remained revoked.  As such, it is speculative to contend that Petitioner would have regained his DEA registration if IDFPR had granted his petition for reinstatement.  Furthermore, it is not clear to me that the restoration of Petitioner’s DEA registration would invalidate CMS’s decision to revoke Petitioner’s Medicare enrollment in any event.

Appellate decisions of the Departmental Appeals Board (DAB) have upheld revocations based on subsection 424.535(a)(1) where a supplier’s professional license is suspended for any length of time, even if the license has been reinstated at the time CMS revokes the supplier’s Medicare enrollment.  See, e.g., Angela R. Styles, M.D., DAB No. 2882 at 8 (2018); Meindert Niemeyer, M.D., DAB No. 2865 at 8-10 (2018); Akram A. Ismail, M.D., DAB No. 2429 at 8 (2011).  If I interpret subsection 424.535(a)(13) in parallel fashion, CMS would remain authorized to revoke Petitioner’s Medicare enrollment even if Petitioner’s Illinois controlled substances license and DEA registration were reinstated before CMS issued the initial determination in this case.  I need not resolve this issue in the present case, however, because it is undisputed that Petitioner had not regained either his Illinois controlled substances license or his DEA registration when CMS revoked his Medicare enrollment.

Moreover, even if Petitioner’s DEA registration were restored at some point after his Medicare enrollment was revoked, Petitioner remains under a reenrollment bar for five years, effective August 15, 2020.  CMS Ex. 2 at 3.  In comments to the final rule promulgating subsection 424.535(a)(13), CMS addressed whether a physician could reenroll in the Medicare program “after the suspension or revocation of [the physician’s] DEA registration is lifted.”  79 Fed. Reg. 29,844, 29,897 (May 23, 2014).  According to CMS, in that situation, the physician could seek enrollment “upon the expiration of his or her reenrollment bar.”  Id.  The comment suggests that a physician whose DEA registration is restored may later reenroll in the Medicare program, but only after the reenrollment bar ends.  As such, the comment does not support interpreting the regulation to mean that the physician’s Medicare enrollment would be reinstated automatically once the DEA registration is restored.

Finally, to the extent Petitioner is seeking equitable relief due to the delays in reinstating his Illinois controlled substances license, I cannot grant such relief.  Arriva Med. LLC, DAB No. 2934 at 16 (2019) (citing Cent. Kan. Cancer Inst., DAB No. 2749 at 10 (2016)).

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In a similar appeal to equity, Petitioner urges me to “consider the significant impact” of the Medicare revocation on his patients, approximately 40% of whom have insurance through Medicare only and “[r]oughly 90%” of that subset are Polish speaking, an “underserved and underrepresented population.”  P. Br. at 3.  Even accepting these facts as true, none of them is a basis to set aside the revocation of Petitioner’s Medicare enrollment and billing privileges.  As an administrative law judge, I am “authorized to review only whether CMS had a legal basis to revoke [a supplier’s] Medicare billing privileges, not CMS’s exercise of discretion to do so.”  Lorrie Laurel, PT, DAB No. 2524 at 7 (2013) (citing Letantia Bussell, M.D., DAB No 2196 at 12-13 (2008)).  Thus, once CMS establishes a legal basis on which to proceed with a revocation, as it has done here, then the CMS determination to revoke becomes a permissible exercise of discretion which I am not permitted to review.  Bussell, DAB No. 2196 at 10; Abdul Razzaque Ahmed, M.D., DAB No. 2261 at 19 (2009), aff’d, Ahmed v. Sebelius, 710 F. Supp. 2nd 167 (D. Mass. 2010) (If CMS establishes the regulatory elements necessary for revocation, administrative law judges may not substitute their “discretion for that of CMS in determining whether revocation is appropriate under all the circumstances.”).

In summary, because Petitioner’s DEA registration was revoked, CMS had a basis to revoke Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(13).  I am not authorized to overturn CMS’s exercise of discretion based on Petitioner’s arguments, which are essentially equitable.  In the following section of this decision, I consider whether CMS properly placed Petitioner on the preclusion list.

2. CMS had a legal basis to add Petitioner to the preclusion list effective September 8, 2020.

The relevant regulations establish three requirements that must be met for CMS to include an individual or entity on its preclusion list: 

(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, 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.

42 C.F.R. §§ 422.2, 423.100 (definitions of preclusion list).

Here, the regulatory requirements to include Petitioner on CMS’s preclusion list have been met.  At the time CMS made its preclusion list determination on July 16, 2020, Petitioner was “revoked from Medicare” under 42 C.F.R. § 424.535(a)(13) and was under a reenrollment bar pursuant to 42 C.F.R. § 424.535(c).  CMS Ex. 2 at 1, 3.  Additionally, CMS determined that the underlying conduct was detrimental to the best interests of the Medicare program.  CMS Ex. 1 at 3-4.  In its reconsidered determination, CMS explained:

CMS considers the loss of a DEA Registration for prescribing, ordering, and/or delegating the prescribing or ordering of, any substances listed in Schedules I-V, to be serious in nature.  CMS is concerned that the improper prescribing practice may be duplicated in the Medicare program.  Furthermore, the suspension or revocation of a DEA Registration is a clear indicator that the physician or eligible professional may be misusing or abusing his or her authority to prescribe such substances.

With regard to the second factor, CMS considers the degree to which the individual’s conduct could affect the integrity of the Medicare program.  [Petitioner’s] controlled substance license was suspended because he engaged in the non-therapeutic prescribing of controlled substances and violated state and federal controlled substance regulations . . . .  [Petitioner’s] inappropriate prescribing of controlled substances represents a serious threat to the health and safety of Medicare beneficiaries.  CMS finds that [Petitioner’s] actions show dangerous and noncompliant behavior and a complete disregard for federal government rules and regulations.  Further, [Petitioner’s] conduct also calls into question his ability to be a trustworthy Medicare partner.  CMS is responsible for protecting Medicare beneficiaries and the Medicare Trust Funds, and the integrity of the Medicare program is dependent on the reliability, integrity, and good judgement [sic] of its partners.  [Petitioner’s] participation in the Medicare program would significantly and negatively affect the integrity of the program

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With regard to the third factor, CMS considers any other evidence relevant to its determination.  It is very relevant that [Petitioner’s] medical license . . . . was also suspended for his improper prescribing of controlled substances . . . .  Due to the loss of his medical license, [Petitioner] is not in compliance with the applicable licensure and certification requirements.  For all of the reasons stated above, CMS determines . . . the conduct underlying [Petitioner’s] revocation to be considerably detrimental to the best interests of the Medicare program and as having an adverse effect on the integrity of the program.

CMS Ex. 1 at 3-4 (footnote omitted).  As this discussion demonstrates, CMS considered the seriousness of Petitioner’s conduct, the degree to which Petitioner’s conduct could negatively impact the integrity of the Medicare program, and other relevant evidence.

Petitioner does not dispute that his Medicare billing privileges have been revoked or that he is under a reenrollment bar.  Petitioner argues instead that CMS “has not demonstrated” that his conduct is detrimental to the best interests of the Medicare program.  P. Br. at 4.

Initially, it is not clear to me that, in reviewing CMS’s decision to place a provider or supplier on the preclusion list, I am authorized to evaluate how CMS applied the factors enumerated in 42 C.F.R. §§ 422.2 and 423.100.  In other contexts, appellate decisions of the DAB have emphasized that, where the regulations grant CMS discretion to determine that a provider or supplier’s underlying conduct is detrimental to Medicare, I may not substitute my own determination for that of CMS.  Brian K. Ellefsen, DO, DAB No. 2626 at 7 (2015); Pa. Physicians, P.C., DAB No. 2980 at 13 (2019). Moreover, I may presume that CMS properly discharged its duty under the regulations absent “clear evidence to the contrary.”  Douglas Bradley, M.D., DAB No. 2663 at 14 (2015) (quoting United States v. Chem. Found., Inc., 272 U.S. 1, 14-15 (1926)).

I need not decide the scope of CMS’s discretion in preclusion cases to resolve this case, however, because, even if I were authorized to review CMS’s determination that Petitioner’s underlying conduct is detrimental to the best interests of the Medicare program, I would not find any error by CMS.  Petitioner’s arguments to the contrary do not persuade me otherwise.

First, Petitioner argues that the underlying conduct that led to the revocation occurred over four years ago and that, since then, he has completed “a significant number of continuing medical education courses to correct the alleged underlying actions and to improve his practice.”  P. Br. at 4.  Petitioner further points out that his medical license has been restored to probation and that he has been practicing medicine full time.  Id.  According to Petitioner, he has referred and will continue to refer patients that require chronic pain management to other specialized providers so “[t]here is no danger” that he

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will treat those types of patients.  Id. at 4-5.  Petitioner adds that it is “illogical” for CMS to be concerned that Petitioner’s improper prescribing practices could be duplicated in the Medicare program because, with his DEA registration revoked and Illinois controlled substances license suspended, it is not possible for him to duplicate those practices.  Id. at 5.

I accept Petitioner’s representations that he has completed continuing education related to his past conduct, and I recognize that conduct occurred several years ago.  I also acknowledge Petitioner’s point that he is not authorized to prescribe controlled substances while his controlled substances license is currently suspended.  But Petitioner argued elsewhere that he has been seeking to restore his license.  P. Br. at 3.  CMS could reasonably determine that placing Petitioner on the preclusion list is warranted based on the risk he will again write improper prescriptions, once his license is restored.  As noted, CMS considered the loss of Petitioner’s DEA registration, which was related to the misuse or abuse of his prescribing authority, to be “serious in nature.”  CMS Ex. 1 at 4.

As for the “the integrity of the Medicare program,” Petitioner reiterates his argument that his many Polish-speaking patients would be “unfairly impacted” by CMS’s determination to place him on the preclusion list.⁵  P. Br. at 5.  Petitioner adds that “none of the allegations leading to the disciplinary action on his license concerned Medicare recipients.”  Id.

Petitioner misunderstands the relevant regulatory factor that CMS must consider, which is “the degree to which [Petitioner’s] conduct could affect the integrity of the Medicare program.”  42 C.F.R. §§ 422.2; 423.100 (emphasis added).  As CMS explained in its reconsidered determination, the integrity of the Medicare program is dependent on the

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reliability, integrity, and good judgment of its partners.  CMS Ex. 1 at 4.  CMS expressed reasonable doubts that Petitioner could be a trustworthy Medicare partner based on his past inappropriate prescribing of controlled substances, which CMS found to be “a serious threat to the health and safety of Medicare beneficiaries” and “dangerous.”  Id.  Whether Petitioner’s past conduct involved Medicare patients is irrelevant because prescribing controlled substances improperly to anyone still undermines his trustworthiness.

As for “any other evidence relevant” to the preclusion list determination, Petitioner argues that CMS should not have considered the suspension of his medical license because it was based on the same underlying allegations that resulted in the revocation of his DEA registration, not “new or additional allegations.”  P. Br. at 5-6.  Petitioner cites no authority for his argument; further, his reasoning is unpersuasive.  The suspension of Petitioner’s medical license is “very relevant” to the preclusion list determination precisely because it is based on the same underlying allegation that resulted in the revocations of Petitioner’s DEA registration and Medicare enrollment.  CMS Ex. 1 at 4.  The additional adverse action further underscores the seriousness of Petitioner’s past conduct.  Furthermore, as CMS noted, the license suspension also put Petitioner out of compliance with Medicare enrollment requirements.  CMS Ex. 1 at 4; 42 C.F.R. §§ 424.535(a)(1), 424.516(a)(2).

In sum, Petitioner’s arguments do not persuade me to set aside CMS’s determination to place Petitioner on its preclusion list.  CMS had a legal basis to revoke Petitioner’s Medicare enrollment and billing privileges and to place him on the preclusion list pursuant to the above cited authority.

V.    Conclusion

For the reasons explained above, I affirm CMS’s revocation of Petitioner’s Medicare enrollment and billing privileges and the placement of Petitioner on CMS’s preclusion list.

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Endnotes

¹  A “supplier” is “a physician or other practitioner, or an entity other than a provider, that furnishes health care services under Medicare.”  42 C.F.R. § 400.202.

²  CMS amended 42 C.F.R. part 498 to add sections 498.3(b)(20) and 498.5(n), authorizing providers and suppliers to appeal their inclusion on the preclusion list, effective June 15, 2018.  83 Fed. Reg. 16,440, 16,757 (Apr. 16, 2018).

³  My numbered findings of fact/conclusions of law appear in bold italic type.

⁴  At or about the same time, IDFPR temporarily suspended Petitioner’s license to practice medicine for similar reasons.  IG Ex. 5 at 2.  IDFPR later placed Petitioner’s medical license on probation.  Id.

⁵  To the extent Petitioner is arguing that “exceptional circumstances” exist to remove him from the preclusion list based on the potential impact to his Polish-speaking patients, I note that CMS is likely best positioned to assess the need for physician services in the geographic area where Petitioner practices.  See 42 C.F.R. § 422.222(a)(6); 84 Fed. Reg. 15,680, 15,832 (Apr. 16, 2019) (effective January 1, 2020, CMS is authorized to remove an individual from the preclusion list if it determines that exceptional circumstances exist regarding beneficiary access to Medicare Advantage items, services, or drugs).  I also presume that CMS conducted the required analysis and determined that “exceptional circumstances” did not justify excepting Petitioner from placement on the preclusion list.  See Brian K. Ellefsen, DAB No. 2626 at 7 (citing U.S. Postal Serv. v. Gregory, 534 U.S. 1, 10 (2001) (“[A] presumption of regularity attaches to the actions of Government agencies . . . .”)); United States v. Chem. Found., Inc., 272 U.S. 1, 14-15 (1926) (“The presumption of regularity supports the official acts of public officers,” so “in the absence of clear evidence to the contrary, courts presume that they have properly discharged their official duties.”).