Ifeanyi Udezulu, M.D. and Lily Internal Medicine & Associates, LLC, DAB CR5986 (2021)

DECISION

The Centers for Medicare & Medicaid Services (CMS), through its Medicare administrative contractor, Novitas Solutions, Inc. (Novitas), revoked the enrollment and billing privileges of Ifeanyi Udezulu, M.D. (Dr. Udezulu), and his internal medicine practice, Lily Internal Medicine & Associates, LLC (together, Petitioners) pursuant to 42 C.F.R. §§ 424.535(a)(1) (noncompliance), 424.535(a)(8)(ii) (abuse of billing privileges), and 424.535(a)(9) (failure to report).  CMS determined that Petitioners had submitted claims to Medicare for services during a period in which Dr. Udezulu’s medical license was suspended and failed to report the license suspension, as required.

Subsequently, CMS placed Dr. Udezulu 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

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furnished, ordered, or prescribed by an individual or entity included on the preclusion list.  42 C.F.R. §§ 422.222, 423.120(c)(6).  Petitioners appealed the revocation of their enrollment and billing privileges and Dr. Udezulu appealed his placement on CMS’s preclusion list.  As explained below, I conclude that CMS had legal bases to revoke Petitioners’ Medicare enrollment and billing privileges and to place Dr. Udezulu on its preclusion list.

I.   Case Background and Procedural History

Dr. Udezulu and his practice, Lily Internal Medicine and Associates, LLC, participated in the Medicare program as “suppliers” of services.1  In separate notice letters, each dated January 9, 2019, Novitas informed Dr. Udezulu and his practice that, effective November 20, 2018, and February 8, 2019, respectively, their enrollment and billing privileges would be revoked for abuse of billing privileges under 42 C.F.R. § 424.535(a)(8)(ii), noncompliance under 42 C.F.R. § 424.535(a)(1) (Dr. Udezulu only), and failure to report Dr. Udezulu’s license suspension under 42 C.F.R. § 424.535(a)(9) and that both would be barred from reenrolling in Medicare for three years pursuant to 42 C.F.R. § 424.535(c).  CMS Exhibit (Ex.) 2.2   In relevant part, the notice letter to Dr. Udezulu stated:

42 CFR § 424.535(a)(8)(ii) – Abuse of Billing Privileges

As a basic Medicare enrollment requirement, a provider or supplier must maintain [a]s a basic Medicare enrollment requirement [appropriate] state licensure based on the type of services the provider or supplier type will furnish and bill Medicare.  See 42 C.F.R. § 424.516(a)(2).  Your medical license was suspended on November 20, 2018.

Data analysis was conducted on claims billed by Lily Internal Medicine and Associates, LLC, on which you were listed as the rendering provider, during a period of time that you[r] medical license was suspended.  This analysis reveals three (3) claim submissions for three (3) unique beneficiaries, with a date of service of November 21, 2018.  See Enclosure A.

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Accordingly, you purportedly provided medical services after your medical license was suspended.  The billing for claims submitted on your behalf while your medical license was suspended was abusive and improper.

42 CFR § 424.535(a)(1) – Noncompliance

Your Delaware medical license was suspended on November 20, 2018.  You do not currently have a valid medical license in the state of Delaware.

42 CFR § 424.535(a)(9) – Failure to Report

Your Delaware medical license was suspended on November 20, 2018.  You did not notify the Centers for Medicare & Medicaid Services of this adverse legal action as required under 42 CFR § 424.516. 

Id. at 5-6.  Other than omitting 42 C.F.R. § 424.535(a)(1) as a basis for revocation, the revocation letter to Dr. Udezulu’s practice does not differ in any material respect from the revocation letter to Dr. Udezulu.  Compare id. with id. at 1-2.  The revocation letter to the practice refers to Dr. Udezulu as “an owner of Lily Internal Medicine and Associates, LLC” and as “the rendering provider.”  Id. at 1. 

Petitioners requested reconsideration in filings on practice letterhead, both signed by Dr. Udezulu.  CMS Exs. 3, 9.3   In separate reconsidered determinations, each dated June 14, 2019, and addressed to attorney David C. Kane (Mr. Kane), CMS’s Provider Enrollment & Oversight Group upheld Novitas’ determinations to revoke Petitioners’ enrollment and billing privileges and to bar Petitioners from reenrolling in Medicare for three years.  CMS Ex. 19.  In relevant part, CMS found that Dr. Udezulu and his practice had abused their billing privileges by submitting three claims to Medicare for services to three different Medicare beneficiaries “while his medical license was suspended” and that neither Dr. Udezulu nor the practice timely reported the license suspension to CMS.  Id. at 7, 16.  The reconsidered determination for Dr. Udezulu also stated that Dr. “Udezulu was not in compliance with Medicare requirements when his medical license was suspended by the Delaware Board of Medical Licensure and Discipline.”  Id. at 16.

Petitioners timely requested administrative law judge hearings to challenge CMS’s revocations of Petitioners’ billing privileges.  The hearing requests were filed on practice

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letterhead and were signed by Dr. Udezulu, with “cc” to Mr. Kane.4   The hearing requests were accompanied by multiple enclosures.  Dr. Udezulu’s hearing request was docketed as Docket No. C‑19‑940; his practice’s hearing request was docketed as Docket No. C‑19‑941, and each case was assigned to me.  On July 26, 2019, CMS filed an unopposed motion to consolidate the two cases.  DAB E-File Docket Entry 6 (Docket No. C-19-941).  On August 5, 2019, I issued a Consolidation Order consolidating both appeals under Docket No. C‑19‑941.  DAB E-File Docket Entry 7 (Docket No. C-19-941). 

By letter dated July 31, 2019, CMS notified Dr. Udezulu that he would be added to CMS’s preclusion list, effective January 1, 2020, based on the revocation of his billing privileges, his current status under a reenrollment bar, and CMS’s determination that his conduct leading to the enrollment revocation was “detrimental to the best interests of the Medicare program.”5   CMS Ex. 20 at 1.6   Dr. Udezulu requested reconsideration and, in a

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reconsidered determination dated November 25, 2019, CMS upheld its determination to place Dr. Udezulu on the preclusion list.  CMS Exs. 21, 26.

On December 23, 2019, Dr. Udezulu filed a hearing request, with multiple and voluminous enclosures, for the November 25, 2019 reconsidered determination placing him on the preclusion list.  Dr. Udezulu filed the hearing request on practice letterhead, signed by Dr. Udezulu, with “cc” to Mr. Kane.  DAB E-File Docket Entries 1-1a, 2-2c, 3‑3e, 4-4h (Docket No. C-20-207).  This hearing request was docketed as Docket No. C‑20‑207 and the case was assigned to me.  On December 31, 2019, I issued an Acknowledgment, Consolidation, and Pre‑hearing Order (Pre-hearing Order) consolidating Docket No. C‑19‑941 (including the previously consolidated Docket No. C-19-940) under Docket No. C‑20‑207.  Under the Pre-hearing Order, CMS’s pre‑hearing exchange was due February 4, 2020, and Dr. Udezulu’s pre-hearing exchange was due March 10, 2020.  Pre-hearing Order ¶ 5.

In response to the Pre-hearing Order, on February 4, 2020, CMS filed a motion for summary judgment or, in the alternative, its pre-hearing brief, seven proposed exhibits (CMS Exs. 20-26), and an updated list of proposed exhibits (CMS Exs. 1-26).  In addition to the enclosures filed with his hearing request on December 23, 2019, Dr. Udezulu filed additional submissions on January 19, 2020, January 20, 2020, February 5, 2020, February 15, 2020, February 16, 2020, March 8, 2020, and March 10, 2020 (also Dr. Udezulu’s pre‑hearing exchange date).7   On March 24, 2020, CMS filed objections to Dr. Udezulu’s proposed exhibits and its reply to Dr. Udezulu’s opposition to the motion for summary judgment.  On March 29, 2020, Dr. Udezulu filed itemized lists of exhibits for Docket Nos. C‑20-207 and C-19-941.  On April 3, 2020, I issued an order closing the administrative record in this case.8   Later on April 3, 2020, Dr. Udezulu filed two more submissions as P. Exs. 30 and 31.

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No parties have proposed witnesses in any of the consolidated cases.  Thus, a hearing is not necessary, and I decide this case on the written record without considering whether the standard for summary judgment is met.  Pre-hearing Order ¶¶ 10, 11.  I deny CMS’s motion for summary judgment as moot. 

The parties filed briefs under prior Docket No. C-19-941 (Docket Entries 8 and 9), and under Docket No. C-20-207 (Docket Entries 11 and 36).  I have reviewed those briefs and considered the arguments therein.  However, the briefs in each case are substantially similar, except that the CMS brief in Docket No. C-20-207 primarily addresses Dr. Udezulu’s inclusion on CMS’s preclusion list.  Therefore, for simplicity, I cite to the parties’ briefs in Docket No. C‑19‑941 when addressing the parties’ contentions, except in my discussion of CMS’s placement of Dr. Udezulu on the preclusion list.

In Docket No. C-19-941, CMS filed a reply brief and objected to duplicative and new evidence, including P. Exs. 1-3, submitted by Petitioner without good cause.  CMS Reply Br. at 3-4 (citing42 C.F.R. § 498.56(e)) (DAB E-File Docket Entry 10 (Docket No. C‑19‑941)).  In Docket No. C-20-207, CMS filed a reply brief, stating that Dr. Udezulu submitted approximately 54 total exhibits and objecting to P. Exs. 4-23A, 24-25, and 27 as duplicative, new evidence without good cause, or irrelevant character references.  CMS Reply Br. at 1, 3 (DAB E-File Docket Entry 38 (Docket No. C-20-207).  Petitioners did not file objections to CMS exhibits in Docket No. C-19-941, and Dr. Udezulu filed a rebuttal in Docket No. C-20-207, in which he also does not object to CMS exhibits, but argues for inclusion of all Petitioner exhibits in the record.  P. Reply at 2 (DAB E-File Docket Entry 42 (Docket No. C‑20‑207)).  As previously noted, Petitioners are in fact proceeding pro se, as their purported counsel has not requested case access in Docket Nos. C‑19‑941 or C‑20‑207.  Because Petitioners appear pro se, and in the interest of making a complete administrative record, I find good cause for admission of all Petitioner exhibits and submissions into the record.  42 C.F.R. §§ 498.56(e),422.222(a)(2)(i), 423.120(c)(6)(v)(A), 498.60(b)(1).  I admit into the record CMS Exs. 1-26, P. Exs. 1-6 (Docket No. C-19-941) and P. Exs. 1‑31 (Docket No. C‑20‑207).  Pre-hearing Order ¶ 7.

II.   Issues

The issues in this case are:

Whether CMS had a legal basis to revoke Dr. Udezulu’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(1);

Whether CMS had a legal basis to revoke Petitioners’ Medicare enrollment and billing privileges under 42 C.F.R. §§ 424.535(a)(8)(ii) and 424.535(a)(9); and

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

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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);9 Social Security Act (Act)§ 1866(j)(8) (42 U.S.C. § 1395cc(j)(8)).

IV.   Discussion

A.  Statutory and Regulatory Framework

Petitioners participated as “suppliers” in the Medicare program, as Dr. Udezulu is a doctor of medicine and his practice is an entity that furnishes health care services.  Act § 1861(d) (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).  Revocation is effective 30 days after CMS mails the initial determination revoking Medicare billing privileges, except in certain circumstances that include “license suspension or revocation . . . .”  42 C.F.R. § 424.535(g).  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 revocation determinations, the length of the reenrollment bar ranged from one to three years.  42 C.F.R. § 424.535(c)(1) (2019). 

Individuals and entities whose enrollment have 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).

In the case of preclusion from ordering Medicare Advantage items or services, CMS has the discretion not to include a particular individual or entity on (or if warranted, remove the individual or entity from) the preclusion list should CMS determine that exceptional circumstances exist regarding beneficiary access to items, services, or drugs.  In making such a determination, CMS considers: 

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(i) The degree to which beneficiary access to Medicare Advantage items, services, or drugs would be impaired; and

(ii) Any other evidence that CMS deems relevant to its determination. 

42 C.F.R. § 422.222(a)(6).10

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

1.  CMS had a legal basis to revoke Dr. Udezulu’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(1) because the Delaware Board of Medical Licensure and Discipline suspended Dr. Udezulu’s license to practice medicine effective November 20, 2018.11  

Under 42 C.F.R. § 424.535(a)(1), CMS may revoke a Medicare supplier’s enrollment and billing privileges if the supplier no longer meets the enrollment requirements for a supplier of its type and the supplier has not submitted a corrective action plan (CAP).  Supplier enrollment requirements include complying with federal and state licensure provisions.  42 C.F.R. § 424.516(a)(2).  As a physician, Dr. Udezulu must be licensed by the state in which he practices medicine.  42 C.F.R. § 410.20(b).  Petitioners concede that the Delaware Board of Medical Licensure and Discipline (Delaware Board) suspended Dr. Udezulu’s license to practice medicine.  P. Br. at 4.

By order issued November 20, 2018, the Delaware Board granted an “Emergency Temporary Suspension” of Dr. Udezulu’s license.  CMS Ex. 18.  In this order, the Delaware Board noted that the Delaware Department of Justice had filed “a written Complaint and Motion for Temporary Suspension,” alleging, in part, that Dr. Udezulu had not complied with requirements for prescribing controlled substances to four patients.  Id. at 1-2.  The Delaware Board determined that Dr. Udezulu’s “continued practice presents a clear and immediate danger to the public health.”  Id. at 3.  On or about January 19, 2019, the Delaware Board entered into a Consent Agreement with Dr. Udezulu to resolve the pending disciplinary action against his medical license.  CMS Ex. 9 at 10‑26; see also CMS Ex. 12.  As part of the Consent Agreement, Dr. Udezulu admitted, among other things, that:  1) he failed to comply with the Board’s regulations governing the use of controlled substances for the treatment of pain; 2) he failed to adequately maintain and properly document patient records; 3) he engaged in misconduct, incompetence, gross negligence, or a pattern of negligence in the practice of medicine; and 4) his violations were likely to harm or injure the public or an individual. 

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Id. at 21-22 (¶¶ 78‑81).  Pursuant to the Consent Agreement, the Delaware Board placed Dr. Udezulu’s medical license on probation for five years.  Id. at 22 (¶ 82).  During the period of his probation, Dr. Udezulu was subject to the following restrictions:  1) he was prohibited from providing chronic pain management treatment; 2) he was required to complete continuing education in documentation, ethics, and safe prescribing practices; 3) he was required to engage an independent auditing company to review his practice and to make quarterly reports to the Board; 4) he was required to pay a fine of $2,000.  Id.

Dr. Udezulu states that he did not receive notification of the license suspension by U.S. Mail until November 26, 2018.  P. Br. at 4.  However, even accepting that Dr. Udezulu did not receive the mailed copy of the suspension notice until November 26, this does not alter the fact that Dr. Udezulu’s license was suspended effective November 20, 2018, and remained so until at least January 19, 2019.  See CMS Ex. 12.  As an appellate decision of the DAB explained, “[b]ecause Petitioner could not practice medicine . . . while his medical license was suspended, he was not compliant with state licensure requirements established by the applicable Medicare enrollment regulations and thus was subject to revocation under 42 C.F.R. § 424.535(a)(1).”  Glenn Alden Harrison, M.D., DAB No. 3023 at 6 (2020).  Moreover, the Harrison decision held that the temporary nature of the license suspension was “immaterial,” finding instead that “[i]t is the fact of the suspension that triggers CMS’s authority to revoke . . . .”  Id. at 7 (citing Akram A. Ismail, M.D., DAB No. 2429 at 8 (2011)).  As the decision further explained:  “Once the suspension took effect, CMS had authority to revoke Petitioner’s enrollment and billing privileges . . . .”  Id. at 9.

Similarly, in the present case, once Dr. Udezulu’s license was suspended, CMS was authorized to revoke his Medicare enrollment, regardless of the date on which Dr. Udezulu received notification of the suspension.  Dr. Udezulu was not authorized to practice medicine in Delaware during the time his license was suspended (November 20, 2018, through January 19, 2019); he therefore was noncompliant with state licensure requirements.  For these reasons, CMS has established a basis for revocation of Dr. Udezulu’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(1), based on the suspension of his state medical license. 

2.  CMS had a legal basis to revoke Petitioners’ Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(9) because they failed to report to CMS or its contractor Dr. Udezulu’s license suspension within 30 days.

“CMS may revoke a currently enrolled [supplier’s] Medicare billing privileges and any corresponding [supplier] agreement” where the “supplier did not comply with the reporting requirements specified in § 424.516(d)(1)(ii) and (iii) of this subpart.”  42 C.F.R. § 424.535(a)(9).  These reporting requirements mandate that a supplier report to the appropriate CMS contractor “[a]ny adverse legal action” within 30 days.  42 C.F.R.

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§ 424.516(d)(1)(ii).  A “final adverse action” includes, as relevant here, a “[s]uspension or revocation of a license to provide health care by any State licensing authority.”  42 C.F.R. § 424.502.

Dr. Udezulu does not contend that he reported the suspension of his medical license to CMS or its contractor within 30 days of the suspension (November 20, 2018).  P. Br. at 3-4 (DAB E-File Docket Entry 9 (Docket No. C-19-941)).12   Dr. Udezulu asserts that his “failure to report to CMS was in part due to” his erroneous belief that contacting the state licensing agency satisfied his duty to report his license suspension to CMS, the federal agency.  Id. at 3.  Dr. Udezulu further contends that the short duration of his license suspension, between receipt of notice and resolution with the State of Delaware, “further clouded his understanding of his personal reporting requirement . . . .”  Id.  He explains that he contacted CMS on February 18, 2019, regarding corrective actions concerning his practice.  Id.  However, a party’s misunderstanding or ignorance of the reporting requirement is not a defense.  See Emmanuel Brown, M.D. & Simeon K. Obeng, M.D., DAB CR2145 at 6 (2010).  Further, “[t]here are no exceptions to the requirement to report.”  Phyllis Barson, M.D., DAB CR2510 at 7 (2012). 

The regulation places the burden upon the participating supplier to report any adverse legal action.  42 C.F.R. § 424.516(d)(1)(ii).  Dr. Udezulu was personally obligated under the regulation to report his license suspension within 30 days.  Additionally, he was obligated to do so on behalf of his practice.  The applicable regulation provides:  “[p]hysicians, nonphysician practitioners and physician and nonphysician practitioner organizations must report the following reportable events to their Medicare contractor . . . .”  42 C.F.R. § 424.516(d)(1)(ii) (emphasis added); see also Gulf South Med.& Surgical Inst., & Kenner Dermatology Clinic, Inc., DAB No. 2400 at 6-9 (2011) (corporate entities as well as their physician owner had a duty to report).  Because the regulation requires both physicians and physician organizations to report adverse legal actions, both Dr. Udezulu and his practice were required to report Dr. Udezulu’s license suspension.  It is undisputed that neither did so.

Rather, Dr. Udezulu contacted CMS on February 18, 2019, 90 days after the suspension, not to report the suspension, but to discuss his corrective actions.  P. Br. at 5.  Therefore, he violated 42 C.F.R. § 424.535(a)(9) and CMS was legally authorized to revoke his Medicare enrollment and that of his practice on that basis.  Dr. Udezulu’s license was suspended effective November 20, 2018, and CMS revoked his billing privileges by letter

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dated January 9, 2019, after more than 30 days had elapsed.13   In summary, I conclude that CMS had a legal basis to revoke Petitioners’ enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(9) because neither Dr. Udezulu nor his practice reported Dr. Udezulu’s medical license suspension within 30 days, as required by 42 C.F.R. § 424.516(d)(1)(ii).

3.  I need not decide whether CMS had a legal basis to revoke Petitioners’ Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(8)(ii).

Having concluded that CMS had a legal basis to revoke Dr. Udezulu’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(1), and to revoke Petitioners’ enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(9), I need not decide whether CMS also had a basis to revoke Petitioners’ enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(8)(ii).  It is unnecessary for me to do so because the revocation bases under 42 C.F.R. § 424.535(a)(1) and (a)(9) are supported by the record.  See, e.g., Daniel Wiltz & Family Healthcare Clinic, APMC, DAB No. 2864 at 12 (2018) (if one basis for sanction is established, CMS’s action would be sustained “regardless of the existence of any additional bases for revocation.”).  Accordingly, I do not decide whether CMS had a legal basis to revoke Petitioners’ Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(8)(ii).14

4.  CMS had a legal basis to add Dr. Udezulu to the preclusion list effective January 1, 2020.

As applicable to this case, each of the following three requirements 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 under [42 C.F.R.] § 424.535.

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(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.

(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 for Dr. Udezulu’s inclusion on CMS’s preclusion list have been met.15   At the time CMS made its preclusion list determination on July 31, 2019, Dr. Udezulu was “revoked from Medicare” under 42 C.F.R. § 424.535(a)(1), (8)(ii), and (9) and was under a reenrollment bar pursuant to 42 C.F.R. § 424.535(c).  CMS Ex. 20; CMS Ex. 2 at 5-8; CMS Ex. 16 at 1.  Additionally, CMS determined that the underlying conduct was detrimental to the best interests of the Medicare program.  CMS Ex. 26 at 3-4.

Dr. Udezulu does not dispute that his Medicare billing privileges have been revoked or that he is under a reenrollment bar.  P. Br. at 2-3, 7 (DAB E-File Docket Entry 36 (Docket No. C‑20‑207)).  Dr. Udezulu repeats arguments concerning the timing of his license suspension, the negotiated Consent Agreement with the State of Delaware, the subsequent restoration of his license (with restrictions), and the effect that the revocation has on patient access to medical care.  P. Br., passim.

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In the prior sections of this decision, I have considered and rejected Dr. Udezulu’s arguments that CMS improperly revoked Petitioners’ Medicare enrollment and billing privileges.  Further, the preamble to the preclusion regulation makes clear that a preclusion list appeal does not provide the supplier with another opportunity to challenge the underlying revocation of enrollment and billing privileges:

We note, however, that the appeals process is intended to permit a [supplier] to challenge CMS’ placement of the [supplier] on the list and not to challenge the underlying reason for the revocation . . . that led to the preclusion list inclusion.  Indeed, the preclusion appeals process would neither include nor affect appeals of payment denials or enrollment revocations, for there are separate appeals processes for these actions.  Any appeal under this . . . provision will be limited strictly to the individual's inclusion on the preclusion list.

83 Fed. Reg. at 16,663 (emphasis added). 

Here, Dr. Udezulu has offered no evidence or argument that CMS failed to consider the factors relevant to preclusion or that it did so improperly.  P. Br., passim (DAB E-File Docket Entry 36 (Docket No. C‑20‑207)).  To the contrary, in its reconsidered determinations, CMS explicitly considered the factors outlined in 42 C.F.R. §§ 422.2 and 423.100.  For example, the reconsidered determination pertaining to Dr. Udezulu states, in pertinent part: 

[T]he revocation of Dr. Udezulu’s Medicare billing privileges was based on his failure to timely report the suspension of his medical license.  His license was suspended because he failed to follow proper protocol in prescribing controlled substances despite having received a call that his patients were selling their controlled substance prescriptions . . . .  Further, Dr. Udezulu did not keep appropriate medical records, monitor the medications prescribed, periodically review patient treatment and patient physicals, and perform assessments of progress.  Dr. Udezulu’s actions present a potential danger to the health, safety, and welfare of Medicare beneficiaries.  Dr. Udezulu’s careless conduct demonstrates that he [is] unwilling or unable to be a reliable partner in the Medicare program.  Further, CMS relies on providers and suppliers to timely disclose reportable adverse actions to appropriately screen them for continued enrollment in the program. As a result, CMS deems the conduct underlying the

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revocation of Dr. Udezulu’s Medicare billing privileges to be detrimental to the best interests of the Medicare program and having a negative impact on the integrity of the Medicare program.

CMS Ex. 26 at 4.  As this discussion demonstrates, CMS considered the seriousness of Dr. Udezulu’s conduct and the degree to which his conduct could impact the integrity of the Medicare program.16  42 C.F.R. §§ 422.2, 423.100.

Dr. Udezulu argues in his hearing request that “it seems premature to include [him] on the CMS’ Preclusion List” while his appeal concerning the revocation of enrollment and billing privileges is pending.  Hearing Request at 1, (DAB E-File Docket Entry 1 (Docket No. C‑20‑207)).  This argument is unavailing for several reasons.

First, I have above upheld CMS’s determinations to revoke Petitioners’ Medicare enrollment and billing privileges.  Second, as previously discussed, a supplier’s revocation appeal is separate from the supplier’s preclusion list appeal and the latter may not serve as a basis for challenging or changing the former.  Third, CMS issued a reconsidered determination upholding Dr. Udezulu’s placement on the preclusion list.  CMS Ex. 26.  The reconsidered determination is binding unless revised by CMS or unless I find a basis for changing the outcome on appeal.  42 C.F.R. § 498.25(b).  CMS has not revised its reconsidered determination, and I find no basis for changing CMS’s determination to place Dr. Udezulu on the CMS preclusion list.  Finally, the regulation governing the timing of placement on CMS’s preclusion list provides: 

[A]n individual or entity will only be included on the preclusion list after the expiration of either of the following:

(A) If the individual or entity does not file a reconsideration request under [42 C.F.R.] § 498.5(n)(1) . . . , the individual or entity will be added to the preclusion list upon the expiration

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of the 60-day period in which the individual or entity may request a reconsideration; or

(B) If the individual or entity files a reconsideration request under [42 C.F.R.] § 498.5(n)(1) . . . , the individual or entity will be added to the preclusion list effective on the date on which CMS, if applicable, denies the individual's or entity’s reconsideration.

42 C.F.R. § 422.222(a)(3)(i); 42 C.F.R. § 423.120(c)(6)(v)(C) (containing substantially identical language with respect to prescribers under Part D).17

Here, CMS upheld its determination to place Dr. Udezulu on the preclusion list (i.e., CMS denied Dr. Udezulu’s reconsideration request) in a reconsidered determination dated November 25, 2019.  CMS Ex. 26.  CMS did not include Dr. Udezulu on the preclusion list until January 1, 2020.  Id. at 4 (“CMS upholds the determination to include Dr. Udezulu on the CMS Preclusion List, effective January 1, 2020.”).  Accordingly, CMS did not place Dr. Udezulu on the preclusion list until after Dr. Udezulu had exhausted his first-level appeal, i.e., he received an unfavorable reconsidered determination.  Therefore, I uphold CMS’s decision to include Dr. Udezulu on CMS’s preclusion list effective January 1, 2020.

5.  Petitioners’ arguments in equity are not bases to reverse the revocation of Petitioners’ Medicare enrollment and billing privileges or the inclusion of Dr. Udezulu on CMS’s Preclusion List.

Petitioners argue in multiple places that revocation of their Medicare enrollment and billing privileges is inequitable under the circumstances.  Petitioners represent, for example, that Dr. Udezulu believed that the Delaware state licensing authority contacted numerous agencies and third parties concerning his license suspension and that he erroneously believed they would contact CMS on his behalf.  P. Br. at 10 (DAB E-File Docket Entry 9 (Docket No. C‑19-941)); P. Br. at 7 (DAB E-File Docket Entry 36 (Docket No. C-20-207)).  Dr. Udezulu also argues that his practice area and its surroundings are “very underserved,” his patients have difficulty finding another

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physician or medical clinic, and the revocation has caused profound difficulties and anxieties for his patients.  P. Br. at 7 (DAB E-File Docket Entry 36 (Docket No. C‑20‑207)).  Dr. Udezulu submits multiple letters of support, character references, and other documents from patients, fellow practitioners, and agencies.  Id.; see, e.g., DAB E‑File Docket Entries 4a-4h, 8, 9, 12 (Docket No. C‑20-207).

While I acknowledge these arguments, none of them is a basis to set aside CMS’s actions.  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, an administrative law judge may not substitute his or her “discretion for that of CMS in determining whether revocation is appropriate under all the circumstances.”).  Dr. Udezulu presents no argument or authority supporting a different result in preclusion list appeals, and I am not aware of any such authority.

With regard to CMS’s decision to place Petitioner on the preclusion list, Petitioner’s argument that his practice area is “very underserved” may be intended to demonstrate “that exceptional circumstances exist regarding beneficiary access to items, services, or drugs” within the meaning of 42 C.F.R. § 422.222(a)(6).  The regulation provides that CMS has discretion to remove an individual from the preclusion list if such circumstances exist.  If Petitioner did intend to argue that CMS failed to apply 42 C.F.R. § 422.222(a)(6) in this case, I do not find the argument supports reversal of the decision to include Petitioner on the preclusion list.

First, I note that CMS is likely best positioned to assess the need for physician services in the geographic area where Dr. Udezulu practices.  Next, I may presume that CMS conducted the required analysis and determined that “exceptional circumstances” did not justify excepting Dr. Udezulu 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 . . . .”));  U.S. v. Chemical 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.”).  Finally, nothing in the regulations suggests that CMS’s exercise of its discretion to waive, or not to waive, placement on the preclusion list based on beneficiary access issues is reviewable by an administrative law judge.  In another context, an appellate decision of the DAB concluded:  “Even assuming CMS had discretion to refrain from [taking an

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official action] in these circumstances, it chose not to do so, and we have no authority to review that choice.”  City of Sugar Land, DAB No. 2719 at 8 (2016).

Accordingly, because I have determined that CMS had a legal basis to revoke Petitioners’ Medicare enrollment and billing privileges and to place Dr. Udezulu on its preclusion list pursuant to the above cited authority, the regulations do not authorize me to second-guess CMS’s determinations.

6.  Petitioners’ Reenrollment Bars Are Not Reviewable.

Petitioners argue that the circumstances surrounding Dr. Udezulu’s license suspension and subsequent negotiated Consent Agreement call for reducing the three-year reenrollment bar to one year.  P. Br. at 3 (DAB E-File Docket Entry 9 (Docket No. C‑19‑941)).  Petitioners are not entitled to administrative review of CMS’s decision concerning the length of a post-revocation reenrollment bar because that decision is not an “initial determination” described in 42 C.F.R. § 498.3(b).  Vijendra Dave, M.D., DAB No. 2672 at 10-11 (2016). I therefore have no authority to review the length of Petitioners’ reenrollment bar.  Id.

V.   Conclusion

For the reasons explained above, I affirm CMS’s revocation of Petitioners’ Medicare enrollment and billing privileges and the inclusion of Dr. Udezulu on CMS’s preclusion list.

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.
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2. CMS Exs. 1-19 and P. Exs. 1-6 are located in the Departmental Appeals Board (DAB) Electronic Filing System (E-File) for Docket No. C‑19‑941, Docket Entries 8b-8t and 9b‑9g.
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3. Dr. Udezulu submitted multiple supplemental enclosures to the reconsideration requests.  See, e.g., CMS Exs. 6-8, 10, 15 at 2-3.
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4. On September 23, 2019, and January 22, 2020, the Civil Remedies Division (CRD) attorney advisors then assisting me sent emails to Mr. Kane notifying him that Dr. Udezulu had electronically filed notices of appearance for Mr. Kane as counsel in Docket Nos. C‑19‑941 and C-20-207.  The CRD attorneys advised Mr. Kane to request case access and register for DAB E-File.  See, e.g., Docket Entry 46 (Docket No. C‑20‑207); see also Case Tracking entry date July 26, 2019 (Notice of Appearance) (Docket No. C‑19-941).  Mr. Kane did not respond to either of these emails.  Mr. Kane did, apparently, prepare Petitioners’ response to CMS’s motion for summary judgment in Docket No. C-19-941, which Dr. Udezulu uploaded to DAB E-File.  DAB E-File Docket Entry 9 (Docket No. C-19-941).  Nevertheless, because Petitioners’ purported counsel has never registered for DAB E-File or acknowledged communications from my office, I treat Petitioners as pro se parties, with Dr. Udezulu serving as their non‑attorney representative.
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5. In Docket No. C-20-207, Dr. Udezulu submitted as an exhibit an initial determination placiing the practice on the preclusion list, as well as a reconsideration request concerning the same.  DAB E-File Docket Entries 13 and 14 (Docket No. C‑20‑207).  Dr. Udezulu filed each of these documents on February 15, 2020, almost two months after filing the hearing request on December 23, 2019.  No party submitted a reconsidered determination for the practice’s placement on the preclusion list.  I therefore have no jurisdiction to consider this issue.  42 C.F.R. § 498.5(n)(2).
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6. CMS Exs. 20-26 and multiple, nonsequential filings by Dr. Udezulu, including submissions electronically filed as P. Exs. 2-31, are located in DAB E-File under Docket No. C‑20-207.  On March 29, 2020, Dr. Udezulu filed “itemized list[s] of exhibits and documents” for Docket Nos. C-20-207 and C-19-941.  DAB E-File Docket Entries 39 and 40 (Docket No. C-20-207).  The exhibit list for Docket No. C‑20-207 reflects P. Exs. 1-27 and 36, with multiple subexhibits, and the exhibit list for Docket No. C-19-941 lists P. Exs. 1‑6, also with multiple subexhibits.  Id.  It appears that many of these submissions duplicate prior submissions.  None of Petitioners’ exhibits are marked as required by pre‑hearing orders in the consolidated cases.  See, e.g., Acknowledgment, Consolidation, and Pre‑Hearing Order ¶¶ 5-6 (DAB E-File Docket Entry 5 (Docket No. C‑20‑207)).
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7. Dr. Udezulu, acting as his own representative, repeats prior arguments in the Memorandum in Support of Petitioners’ Opposition to Motion for Summary Judgment and Preclusion List Decision filed on March 10, 2020.  DAB E-File Docket Entry #20 (Docket No. C‑20-207).  References to Petitioners’ Brief (P. Br.) shall be to the brief filed in Docket No. C‑19-941 by his previous counsel, unless otherwise noted.
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8. On August 25, 2021, Dr. Udezulu requested permission to make additional submissions to the case record.  I denied his request.  DAB E-File Docket Entries 44 and 45 (Docket No. C‑20‑207).
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9. 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).
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10. CMS added the exception for beneficiary access issues by final rule promulgated April 16, 2019, and effective January 1, 2020.  84 Fed. Reg. 15,680, 15,832 (April 16, 2019).
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11. My numbered findings of fact/conclusions of law appear in bold italic type.
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12. Dr. Udezulu repeats these statements and arguments in his Memorandum in Support of Petitioners’ Opposition to Motion for Summary Judgment and Preclusion List Decision filed on March 10, 2020 in Docket No. C‑20-207, which does not differ in any material respect from his initial brief.  P. Br. at 2-3 (DAB E-File Docket Entry 36 (Docket No. C‑20-207)).
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13. I take administrative notice that January 9, 2019 is 50 days after November 20, 2018.
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14. CMS determined that Petitioners abused their billing privileges within the meaning of 42 C.F.R. § 424.535(a)(8)(ii) because they submitted “three (3) claim submissions for three (3) unique beneficiaries, with a date of service of November 21, 2018[,] . . . after your medical license was suspended.  The billing for claims submitted on your behalf while your medical license was suspended was abusive and improper.”  CMS Ex. 2 at 5‑6.  However, the reconsidered determination articulates an incorrect legal standard.  Three instances of improperly billed claims do not automatically show a pattern or practice of abusive billing under § 424.535(a)(8)(ii).  DRS Health Grp. LLC, DAB CR5444 at 9-10 (2019); see also Michelle Alexandre, DAB CR5422 at 4 (2019).
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15. As previously noted, Dr. Udezulu filed a hearing request in Docket No. C-20-207 solely for his listing on the preclusion list.  DAB E-File Docket Entries 1 and 1a (Docket No. C‑20‑207).  While Dr. Udezulu later filed an initial determination indicating that CMS also placed the practice on the preclusion list, as well as a reconsideration request, that determination is not before me.  DAB E-File Docket Entries 13 and 14 (Docket No. C‑20‑207); see also supra n.5.
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16. It is not clear to me, in reviewing CMS’s decision to place a provider or supplier on the preclusion list, that 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. Chemical Foundation, Inc., 272 U.S. 1, 14-15 (1926)).
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17. The current provisions of 42 C.F.R. §§ 422.222(a)(3)(i) and 423.120(c)(6)(v)(C) were effective January 1, 2020.  84 Fed. Reg. at 15,680, 15,831, 15,840.  However, the preamble to the final rule adopting the 2018 regulations similarly explained that it was CMS’s policy to place suppliers on the preclusion list following an unsuccessful first‑level appeal.  83 Fed. Reg. at 16,656 (“[N]o provider will be added to the preclusion list until they have exhausted their first level of CMS appeal or if they fail to appeal their addition to the list.”).  I therefore do not regard the current version of the regulations as reflecting any change in policy.
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