Sualeh Kamal Ashraf, DAB CR6449 (2024)

DECISION

The Centers for Medicare & Medicaid Services (CMS) revoked the Medicare enrollment of Sualeh Kamal Ashraf, M.D. (Dr. Ashraf or Petitioner) and added Dr. Ashraf’s name to CMS’s Preclusion List because the Drug Enforcement Administration (DEA) revoked Dr. Ashraf’s Certificate of Registration (COR).  For the reasons stated below, I affirm CMS’s actions.

I.     Background and Procedural History

Petitioner is a physician who was enrolled in the Medicare program as a supplier.  On April 20, 2023, a CMS contractor issued an initial determination revoking Petitioner’s Medicare enrollment and billing privileges based on the following reason:

42 CFR §424.535(a)(13) - Prescribing Authority

On February 6, 2023, your Drug Enforcement Administration (DEA) Certificate of Registration was revoked.

Page 2

CMS Ex. 2 at 1.  The CMS contractor also set a five-year bar to reenrollment.  CMS Ex. 2 at 3.  Finally, the CMS contractor added Petitioner’s name to the CMS Preclusion List, which prohibited Petitioner from receiving reimbursement for services provided through a Medicare Part C Medicare Advantage Plan and prohibited Petitioner’s patients from receiving reimbursement through Medicare Part D for drugs prescribed by Petitioner.  CMS Ex. 2 at 1. 

On May 9, 2023, Petitioner requested reconsideration of the initial determination and filed a number of exhibits in support of that request.  CMS Ex. 3.  On November 7, 2023, a CMS hearing officer issued an unfavorable reconsidered determination.  Electronic Filing System (E-File) Doc. No. 1a.

On January 7, 2024, Petitioner filed a request for hearing, which included a lengthy “Memorandum in Support of the Appeal.”  On January 9, 2024, the Civil Remedies Division (CRD) acknowledged the hearing request and issued my Standing Order, which included the dates by which the parties were to submit their prehearing exchanges.  CMS timely filed its prehearing exchange, which included a brief (CMS Br.) and five proposed exhibits.  Petitioner was to file his prehearing exchange by March 19, 2024; however, Petitioner has not filed an exchange.

II.    Admission of Evidence

Petitioner did not object to CMS’s proposed exhibits.  See Standing Order ¶ 10.  Therefore, I admit CMS Exhibits 1 through 5 into the record.

III.  Decision on the Written Record

I directed the parties to submit written direct testimony from all witnesses that the parties wanted to present in this case and stated that the opposing party could request to cross-examine the witnesses.  Standing Order ¶¶ 11-12.  I also advised the following:

If the parties either do not file any written direct testimony or the parties do not request to cross-examine any of the witnesses from whom written direct testimony has been submitted, I will consider such actions by the parties to serve as a constructive request for a decision on the written record because there will be no reason to hold an in-person hearing.

Standing Order ¶ 7(g)(iii); see also Standing Order ¶ 13.  Therefore, “[u]nless a hearing is required for cross-examination of a witness or witnesses, the record will be closed and the case will be ready for a decision after all the submission deadlines have passed.”  Standing Order ¶ 14.

Page 3

In the present case, all deadlines for prehearing submissions have passed and neither party filed written direct testimony.  Therefore, I do not need to hold a hearing and may issue a decision based on the written record.  EI Medical, Inc., DAB No. 3117 at 15 (2023); Vandalia Park, DAB No. 1940 (2004).

Further, Petitioner’s failure to timely file a prehearing exchange does not preclude me from issuing a decision based on the written record.  Anil Hanuman, D.O., DAB No. 3080 at 12 (2022).  Petitioner’s hearing request includes a lengthy memorandum and Petitioner submitted several exhibits with the reconsideration request (CMS Exhibit 3); therefore, I address Petitioner’s arguments and evidence in this decision.

IV.   Issues

1. Whether CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment under 42 C.F.R. § 424.535(a)(13). 
2. Whether CMS had a legitimate basis to place Petitioner’s name on CMS’s Preclusion List under 42 C.F.R. §§ 422.2 and 423.100. 

V.   Jurisdiction

I have jurisdiction to hear and decide the issues presented in this case.  42 C.F.R. §§ 498.3(b)(17), (20), 498.5(l)(2), (n)(2).

VI.  Findings of Fact

1)     Petitioner has been a licensed physician in Florida since 2001.  CMS Ex. 4 at 2; CMS Ex. 5 at 5.

2)     In 2004, Petitioner enrolled as a supplier in the Medicare program.  See CMS Ex. 4 at 1. 

3)     At some time before 2021, Petitioner received a COR from the DEA as “a practitioner in Schedules II-V.”  CMS Ex. 3 at 145 ¶ 4. 

4)     On September 30, 2021, the DEA issued an Order to Show Cause why it should not revoke Petitioner’s COR based on certain alleged facts that made Petitioner’s registration inconsistent with the public interest.  CMS Ex. 1 at 1; CMS Ex. 3 at 146 ¶ 5. 

5)     The facts alleged in the Order to Show Cause included:  issuing more than 30 prescriptions for controlled substances to three individuals with whom Petitioner

Page 4

did not have a valid doctor-patient relationship; having numerous recordkeeping violations; failing to report dispersing information to Florida’s Prescription Drug Monitoring Program; failing to store controlled substances in a secure facility; and dispensing controlled substances without the required warning labels.  CMS Ex. 3 at 146 ¶ 6. 

6)     The DEA served Petitioner with the Order to Show Cause by email; however, Petitioner only submitted a corrective action plan and did not request a hearing to dispute the revocation of the COR.  CMS Ex. 1 at 1 n.1; CMS Ex. 3 at 146 ¶ 7. 

7)     On December 27, 2022, the DEA’s Administrator issued a Decision and Order revoking Petitioner’s COR, effective February 6, 2023.  CMS Ex. 1 at 4.  

8)     The Decision and Order provided the following findings of fact based on the uncontroverted evidence submitted in Petitioner’s COR revocation matter: 

1. Petitioner issued at least 33 prescriptions for controlled substances (i.e., oxycodone, Adderall, hydrocodone, and zolpidem) to three individuals (i.e., J.L., D.L., and J.L.2) between September 27, 2016, and May 24, 2018.  CMS Ex. 1 at 1; see also CMS Ex. 3 at 146 ¶ 8. 
2. Based on a transcript of an interview of Petitioner by the Polk County Sherriff’s Office,¹ Petitioner had no recollection of prescribing oxycodone to the identified individuals.  CMS Ex. 1 at 1. 
3. A DEA investigator made numerous attempts to obtain the patient records for J.L., D.L., and J.L.2, which included the issuance of administrative subpoenas to Petitioner; however, Petitioner was unable to provide those records.  CMS Ex. 1 at 1; see also CMS Ex. 3 at 140, 142, 146 ¶ 8. 
4. The DEA investigator interviewed Petitioner and stated that Petitioner admitted to dispensing controlled substances in March 2017 and admitted to dispensing phentermine directly to uninsured patients.  However, Petitioner failed to produce an initial inventory of controlled substances or any dispensing records of controlled substances, which violated federal regulations.  The investigator concluded that Petitioner could not account for 24,349 tablets of 37.5mg units of phentermine and 250 tablets of 8mg units of phentermine.  The DEA investigator also determined that Petitioner

Page 5

failed to comply with Florida law and report the dispensing of phentermine to the Florida Prescription Drug Monitoring Program.  Further, the DEA investigator determined that Petitioner failed to report the theft of 14 bottles of phentermine to the DEA within one business day in violation of federal regulations, although Petitioner reported it to local law enforcement.  The DEA investigator also determined that Petitioner dispensed phentermine in containers without warning labels conforming to federal regulations, and Petitioner failed to properly store phentermine in a “securely locked, substantially constructed cabinet” as required by federal regulations.  Petitioner admitted that J.L., the clinic owner who was not a DEA registrant, stored controlled substances at J.L.’s home when the clinic was closed.  CMS Ex. 1 at 1; see also CMS Ex. 3 at 148-150 ¶¶ 18-25.

5. The DEA accepted a report from an expert on the standard of care for prescribing controlled substances.  The expert generally concluded, and the DEA agreed in the Decision and Order, that:  Petitioner engaged in a pattern or practice of prescribing that demonstrated a lack of reasonable skill or safety to patients; Petitioner failed to document appropriate physician-patient relationships; and Petitioner’s prescribing of controlled substances was not within the usual scope of professional practice and could not be deemed as issued for legitimate medical purpose.  CMS Ex. 1 at 2; see also CMS Ex. 3 at 148 ¶ 17.  The expert’s more specific findings supporting this conclusion are as follows:
   1. The expert reviewed seven prescriptions for oxycodone issued by Petitioner to J.L. from March 17, 2017, through April 26, 2018, and found four of them were prescribed for “pain.”  Because there were no medical records to review, none of the requirements to prescribe for chronic, nonmalignant pain were met.  CMS Ex. 1 at 2.
   2. The expert reviewed prescriptions for Adderall that Petitioner gave to J.L., D.L., and J.L.2, and concluded that because there were no medical records to review, there was no evidence that Petitioner issued the prescriptions for medical purposes permitted under Florida law or for any legitimate medical purpose.  CMS Ex. 1 at 2.

9)     The Decision and Order summarized Petitioner’s statements in his corrective action plan.  Petitioner explained that he worked with J.L. at a weight loss clinic that J.L. owned.  Petitioner denied writing oxycodone prescriptions for J.L. and indicated that J.L. likely forged Petitioner’s signature on the prescriptions.  Petitioner claimed never to have met D.L. or J.L.2, J.L.’s husband and son.  Petitioner argued that he violated no law because he did not issue the

Page 6

prescriptions in question.  Petitioner stated he would, in the future, more carefully control his prescription pad and personally call prescriptions into pharmacies.  CMS Ex. 1 at 2. 

10)  The Decision and Order provided an analysis of the facts regarding two of the five regulatory factors used to determine the public interest in revoking Petitioner’s COR.  Factor Two is the experience of the individual in dispensing or conducting research with respect to controlled substances.  Factor Four is compliance with applicable state, federal, and local laws relating to controlled substances.  Based on the facts and the expert opinion, the DEA Administrator concluded that Petitioner had violated numerous federal and state laws related to dispensing of controlled substances, and that Factors Two and Four weighed in favor of the public interest in revocation of Petitioner’s COR.  CMS Ex. 1 at 3. 

11)  The Decision and Order also provided an analysis as to whether Petitioner showed that Petitioner should be entrusted with a COR.  The DEA Administrator found that Petitioner did not meet the burden of proof because Petitioner failed to accept responsibility for the prescriptions related to J.L.  Further, Petitioner did not address any of the numerous dispensing violations found by the DEA investigation and, therefore, did not accept responsibility for them as well.  In addition, the DEA Administrator found that Petitioner failed to provide adequate remedial measures for the various violations identified in the case or to identify how Petitioner would ensure future compliance with federal and state laws.  Finally, the DEA Administrator found that revocation of Petitioner’s COR would deter Petitioner and other individuals with a COR from improperly prescribing controlled substances and ignoring their obligations under federal and state law.  CMS Ex. 1 at 4. 

12)  Petitioner filed a Petition for Injunctive Relief and a Petition for Review of the Decision and Order in the United States Court of Appeals for the Eleventh Circuit.  CMS Ex. 3 at 10-70.

VII.  Conclusions of Law and Analysis

1. CMS had a legitimate basis to revoke Petitioner’s enrollment in the Medicare program because the DEA revoked his Certificate of Registration.

A physician who participates in the Medicare program is a “supplier.”  42 U.S.C. § 1395x(d), (r)(1).  The Social Security Act authorizes the Secretary of Health and Human Services (Secretary) to create regulations governing the enrollment of suppliers in the Medicare program.  42 U.S.C. § 1395cc(j).  

Page 7

Under the Secretary’s regulations, a supplier must enroll in the Medicare program to receive payment for covered Medicare items or services.  42 C.F.R. § 424.505.  Once enrolled, CMS may revoke a supplier’s Medicare enrollment and billing privileges for any of the reasons stated in 42 C.F.R. § 424.535(a).

In the present case, CMS revoked Petitioner’s enrollment based on 42 C.F.R. § 424.535(a)(13)(i), which provides that CMS may revoke a supplier if:

The physician or other eligible professional’s Drug Enforcement Administration (DEA) Certificate of Registration to dispense a controlled substance is currently suspended or revoked or is surrendered in response to an order to show cause.

There is no dispute that the DEA revoked Petitioner’s COR in 2023 and that it was still revoked at the time the CMS contractor issued the initial determination in this case.  Hearing Req. at 3.  Therefore, CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment.

Although Petitioner did not dispute the revocation of his COR, Petitioner made a number of arguments as to why I should reverse CMS’s determination to revoke.  Petitioner asserted that CMS does not have to revoke Petitioner’s enrollment based on the DEA’s revocation of the COR if it is not convinced of the DEA’s charges or if Medicare needs physicians to serve in the area where Petitioner is located.  Hearing Req. at 3.  While Petitioner is correct that CMS has discretion whether or not to revoke enrollment, I am without authority to review that act of discretion.  I may only determine whether the facts and law support CMS’s action.  John O. Dimowo, M.D., DAB No. 3101 at 8 (2023).

Petitioner also argued that it would be appropriate to stay the revocation of enrollment until the Eleventh Circuit rules on Petitioner’s appeal of the DEA’s Decision and Order.  Hearing Req. at 3.  However, once CMS issues the notice of initial determination revoking enrollment under 42 C.F.R. § 424.535(a)(13), the revocation becomes effective 30 days after the date of mailing.  42 C.F.R. § 424.535(g).  An ALJ has no authority to ignore that regulation and stay the revocation.  See Dimowo, DAB No. 3101 at 13.

Petitioner points out that the CMS hearing officer erred in the reconsidered determination by stating that the DEA accused Petitioner of improperly prescribing drugs to 33 individuals when in fact the allegation was 33 prescriptions to three individuals.  Hearing Req. at 4.  CMS has conceded this error (CMS Br. at 6) and my findings of fact above reflect the correct allegation from the DEA.  However, this discrepancy is minor and does not affect the efficacy of the revocation. 

Page 8

Petitioner also asserted that a Florida court exonerated Petitioner of criminal wrongdoing and that the Florida Medical Board dismissed misconduct charges against Petitioner in exchange for one-year of probation.  Hearing Req. at 4.  Although Petitioner may have avoided criminal liability and accepted probation to terminate a disciplinary case related to Petitioner’s medical license (CMS Ex. 5), neither of these events impact the fact that the DEA revoked Petitioner’s COR.

Petitioner further argued that the DEA investigator committed fraud in a declaration and made false and incorrect allegations.  Hearing Req. at 4-5.  However, this is not the forum to dispute the DEA investigation.  Petitioner had the opportunity to request a hearing to dispute the Order to Show Cause, which would have included the right to cross-examine witnesses.  See 21 U.S.C. § 824(c)(4) (DEA revocation hearings are conducting under the Administrative Procedure Act (APA)); 5 U.S.C. § 556(d) (APA provides parties to an adjudication the right “to conduct such cross-examination as may be required for a full and true disclosure of the facts.”).  However, Petitioner did not request a hearing.  Therefore, I must accept the conclusions in the Decision and Order, which includes the DEA Administrator’s reliance on the investigator’s declaration.

The Secretary made it clear when promulgating 42 C.F.R. § 424.535(a)(13) that the DEA’s decision to revoke a COR was a cause for concern.  The Secretary stated that “the loss of the ability to prescribe drugs via a suspension or revocation of a DEA Certificate or by state action is a clear indicator that a physician or eligible professional may be misusing or abusing his or her authority to prescribe such substances” and that “we are concerned that a physician or eligible professional’s improper prescribing practices may be duplicated in the Medicare program.”  79 Fed. Reg. 29,844, 29,896 (May 23, 2014). 

If the Eleventh Circuit reverses the DEA’s Decision and Order revoking Petitioner’s COR, then CMS’s revocation of enrollment will no longer have any legal basis.   However, unless and until that happens, CMS’s action is legitimate.

2. CMS had a legitimate basis to add Petitioner to the CMS Preclusion List.

CMS established a single list of individuals and entities for whom Medicare Advantage Plans cannot provide reimbursement for items and services they provide, and for prescribers to whom Medicare Part D plans cannot provide reimbursement for any prescriptions the individuals write.  42 C.F.R. §§ 422.222, 423.120(c)(6).  As relevant here, for CMS to include an individual, entity, or prescriber on its Preclusion List, the following three requirements must be met:

(i) The [individual, entity, or prescriber] is currently revoked from Medicare for a reason other than that stated in [42 C.F.R.] § 424.535(a)(3). . . .

Page 9

(ii) The [individual, entity, or prescriber] 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 . . . , CMS considers the following factors:

(A) The seriousness of the conduct underlying the . . . revocation.

(B) The degree to which the . . . conduct could affect the integrity of the [Medicare/Part D] program.

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

42 C.F.R. §§ 422.2, 423.100.

In the reconsidered determination, the CMS hearing officer upheld the addition of Petitioner’s name to the Preclusion List.  The CMS hearing officer found that Petitioner had been revoked, was under a reenrollment bar, and that the underlying conduct leading to the revocation is detrimental to the best interests of the Medicare program.  E‑File Doc. No. 1a at 5.  A review of the reconsidered determination shows a detailed consideration as to why Petitioner ought to be placed on the Preclusion List. 

Petitioner did not expressly challenge the addition of Petitioner’s name to the Preclusion List or any of the factors discussed by the CMS hearing officer.  Having confirmed that the CMS hearing officer satisfactorily considered all of the required regulatory elements for preclusion, I uphold CMS’s action.  See Dimowo, DAB No. 3101 at 14.

VIII.  Conclusion

I affirm CMS’s revocation of Petitioner’s Medicare enrollment and the inclusion of Petitioner’s name on CMS’s Preclusion List.

Endnotes

¹  Petitioner submitted documentation from the investigation conducted by the Polk County Sheriff’s Office.  CMS Ex. 3 at 74-138.