Milad Ishak Shaker, M.D., DAB CR6595 (2025)

DECISION

I affirm the determination of the Inspector General (IG) of the United States Department of Health and Human Services to exclude Petitioner, Milad Ishak Shaker, M.D., from participation in all federal health care programs for seven years under 42 U.S.C. § 1320a‑7(a)(4).

I. Procedural History

In a December 30, 2022 notice, the IG excluded Petitioner from participation in all federal health care programs. The IG cited section 1128(a)(4) of the Social Security Act (42 U.S.C. § 1320a-7(a)(4)) as the basis for Petitioner’s exclusion. The IG stated that she was taking this action because Petitioner was convicted of a felony offense in the United States District Court for the Western District of Pennsylvania (District Court), related to the unlawful manufacture, distribution, prescription, or dispensing of a controlled substance. The IG increased the length of the exclusion from the mandatory minimum length of five years to seven years based on the following two alleged aggravating factors:

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• The District Court sentenced Petitioner to 41 months of incarceration.
• The Pennsylvania Board of Medicine suspended Petitioner’s license to practice as a medical doctor.

IG Ex. 1 at 1.

On August 14, 2024, the Civil Remedies Division (CRD) received Petitioner’s hearing request through the mail. The filing included a cover page dated August 9, 2024, which stated that Petitioner’s January 6, 2023 hearing request was enclosed. CRD acknowledged receipt of the August 14, 2024 filing, set the prehearing conference for September 24, 2024, emailed the parties that I would consider the timeliness of the hearing request at the conference, and issued my Standing Order. In response, Petitioner submitted various documents, one of which was a screen shot of a United States Postal Service tracking number search showing that an item was delivered on January 13, 2023, to the zip code where CRD is located. Electronic Filing System (E-File) Doc. No. 6.

On September 24, 2024, I held a prehearing conference, the substance of which is summarized in my September 26, 2024 Order Following Prehearing Conference and Setting Schedule for Prehearing Submissions (September 26 Order). At the conference, Petitioner described the circumstances surrounding his effort to request a hearing in January 2023. IG counsel did not object to the timeliness of Petitioner’s hearing request. Therefore, I accepted the hearing request as timely. September 26 Order at 2-3.

At the conference, I noted that Petitioner’s January 2023 hearing request disputed the exclusion and the aggravating factors primarily by: denying that Petitioner had been convicted of a felony; arguing he had been subjected to prosecutorial misconduct and ineffective assistance of counsel; explaining that he had new evidence concerning his criminal case that he wanted to submit in these proceedings; and asserting that the United States Supreme Court case, Ruan v. United States, was favorable to reversal of his conviction. Petitioner also stated he was innocent of the criminal charges against him.

Because Petitioner’s arguments appeared to collaterally challenge his criminal conviction, at the conference I informed Petitioner that I have no authority to decide whether the criminal case against him was properly conducted or whether the evidence in that case should have resulted in conviction or acquittal. 42 C.F.R. § 1001.2007(d); see Travers v. Shalala, 20 F.3d 993, 998 (9th Cir. 1994). I stated that Petitioner must seek resolution to his criminal matter in federal court, which Petitioner appeared to be in the process of doing, and, if Petitioner’s conviction is vacated on appeal, then the IG must reinstate Petitioner. 42 C.F.R. § 1001.3005(a)(1); September 26 Order at 3.

Finally, at the conference, the parties agreed to a prehearing submission schedule. September 26 Order at 5. I informed Petitioner that he needed to submit all of the

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documents he wanted me to consider as exhibits marked in the manner required under my Standing Order. September 26 Order at 4.

On October 29, 2024, the IG submitted a brief (IG Br.) and 12 proposed exhibits (CMS Exs. 1-12). On November 19, 2024, Petitioner filed a brief (P. Br.) and 44 exhibits (P. Exs. 1-44). On November 26, 2024, the IG filed a reply brief. On January 2, 2025, Petitioner submitted a Supplemental Motion for Consideration of New Evidence (P. Supp. Mot.) and two exhibits (P. Supp. Exs. 1-2).

II. Issues

1. Whether the IG has a basis for excluding Petitioner from participating in all federal health care programs under 42 U.S.C. § 1320a-7(a)(4).
2. If Petitioner is subject to exclusion, whether the seven-year length of the exclusion imposed on Petitioner is unreasonable. 42 C.F.R. § 1001.2007(a)(1)(ii).

III. Admission of Evidence and Decision on the Written Record

I admit all of the proposed exhibits into the record, without objection. See Standing Order ¶ 13; 42 C.F.R. § 1005.8(c).

Both the IG and Petitioner indicated that an in-person hearing was unnecessary and that neither had any witness testimony to offer. IG Br. at 12-13; P. Br. at 67. Therefore, I issue this decision based on the written record. Standing Order ¶¶ 12, 16; see also 42 C.F.R. § 1005.6(b)(5).

IV. Jurisdiction

I have jurisdiction to adjudicate this case. 42 U.S.C. § 1320a-7(f)(1); 42 C.F.R. §§ 1001.2007, 1005.2.

V. Findings of Fact

1. The Pennsylvania State Board of Medicine (Board of Medicine) licensed Petitioner to practice medicine in Pennsylvania on June 19, 2009. IG Ex. 12 at 7; P. Ex. 44 at 4.
2. Petitioner’s Pennsylvania license number is MD437512. IG Ex. 12 at 7; P. Ex. 44 at 4.

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Criminal Conviction

3. On October 2, 2018, a grand jury empaneled by the District Court returned an Indictment against Petitioner charging him with 52 counts of violating 21 U.S.C. § 841(a)(1), (b)(1)(C), and (b)(2) for intentionally and unlawfully dispensing and distributing Schedule II and IV controlled substances, and two counts of violating 18 U.S.C. §§ 2 and 1347 by participating in a scheme to defraud a health care benefit program. IG Ex. 2; see also Ex. 2 at 6.
4. On December 18, 2018, the grand jury returned a 56-count Superseding Indictment. IG Ex. 3; P. Ex. 2 at 9.
5. The Superseding Indictment specified that the only defendant was “MILAD SHAKER .. . a physician licensed in the Commonwealth of Pennsylvania and registered by the Drug Enforcement Administration to prescribe controlled substances.” IG Ex. 3 at 1. The Indictment further asserted that “MILAD SHAKER, operated a private family practice and an urgent care facility in Mount Pleasant and Donegal, Pennsylvania.” IG Ex. 3 at 1. The Indictment also stated that Petitioner issued prescriptions for controlled substances to individuals known as T.S. and B.S. in return for sexual favors. IG Ex. 3 at 1.
6. Counts 1 through 31 of the Superseding Indictment charged that “defendant MILAD SHAKER did knowingly, intentionally and unlawfully dispense and distribute, and cause to be dispensed and distributed, a quantity of hydrocodone in the form known as Norco / Vicodin, a Schedule II controlled substance, to an individual known to the grand jury as ‘T.S.’ outside the usual course of professional practice and not for a legitimate medical purpose .. . [i]n violation of Title 21, United States Code, Sections 841(a)(1) and 841(b)(1)(C).” IG Ex. 3 at 2‑3.
7. Counts 32 through 34 of the Superseding Indictment charged that “defendant MILAD SHAKER did knowingly, intentionally and unlawfully dispense and distribute, and cause to be dispensed and distributed, a quantity of oxycodone, in the form known as Percocet, a Schedule II controlled substance, to individuals known to the grand jury as ‘T.S.’ and ‘B.S.’ outside the usual course of professional practice and not for a legitimate medical purpose .. . [i]n violation of Title 21, United States Code, Sections 841(a)(1) and 841(b)(1)(C).” IG Ex. 3 at 4.
8. Counts 35 and 36 of the Superseding Indictment charged that “defendant MILAD SHAKER did knowingly, intentionally and unlawfully dispense and distribute, and cause to be dispensed and distributed, a quantity of hydrocodone bitartrate and homatropine methylbromide syrup, a Schedule II controlled substance, to an individual known to the grand jury as ‘B.S.’ outside the usual course of

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professional practice and not for a legitimate medical purpose .. . [i]n violation of Title 21, United States Code, Sections 841(a)(1) and 841(b)(1)(C).” IG Ex. 3 at 5.

9. Counts 37 through 52 of the Superseding Indictment charged that “defendant MILAD SHAKER did knowingly, intentionally and unlawfully dispense and distribute, and cause to be dispensed and distributed, a quantity of tramadol, commonly known as Ultram, a Schedule IV controlled substance, to an individual known to the grand jury as ‘T.S.’ outside the usual course of professional practice and not for a legitimate medical purpose .. . [i]n violation of Title 21, United States Code, Sections 841(a)(1) and 841(b)(2).” IG Ex. 3 at 6-7.
10. Counts 53 through 56 charged Petitioner with perpetrating a scheme to defraud a health care program, attempting to persuade “B.S.” to delete cell phone text messages relevant to the charges in the Indictment, and making false statements to federal officials. IG Ex. 3 at 8-13.
11. Petitioner pleaded not guilty to the charges in the Superseding Indictment. Ex. 2 at 9.
12. From October 7, 2019 through October 17, 2019, the District Court held a jury trial on the charges against Petitioner. Ex. 2 at 14-15.
13. On October 17, 2019, a jury empaneled by the District Court found Petitioner guilty of nine counts of “Unlawful Distribution of a Schedule II controlled substance” (i.e., Counts 1, 8, 10, 12-15, 28, 29) and five counts of “Unlawful Distribution of a Schedule IV controlled substance” (i.e., Counts 45-47, 51-52). IG Ex. 6; see also Ex. 2 at 15.
14. On December 5, 2019, Petitioner moved for an acquittal; however, on January 6, 2020, the District Court denied the motion. IG Ex. 10 at 8; P. Ex. 2 at 16, 19.
15. On February 7, 2020, the District Court held a hearing to sentence Petitioner. IG Ex. 10. At sentencing, Petitioner continually stated he was innocent of criminal wrongdoing. IG Ex. 10 at 3, 11, 13, 26, 30, 42-43, 49. The District Court stated that nothing Petitioner stated during the hearing undermined the jury’s verdict. IG Ex. 10 at 43. The District Court sentenced Petitioner to 41 months of incarceration. IG Ex. 10 at 50; see also IG Ex. 7; P. Ex. 2 at 20.
16. The District Court issued a Memorandum Order on February 7, 2020, following the sentencing hearing, in which the District Court again denied Petitioner’s motion for acquittal. The District Court stated the following in support of the jury’s guilty verdict: “Contrary to Defendant’s allegations, the Government provided ample evidence at trial that Defendant had an improper purpose in

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prescribing medications to Ms. Skovira—namely, a sexual purpose. The Government notes that Ms. Skovira’s orthopedist forwarded information to Defendant that she no longer needed pain medication, but Defendant continued prescribing her medication, nonetheless. Skovira testified that she saw her sexual relationship with Defendant as transactional and motivated by her desire to obtain these controlled substances. Ms. Skovira’s parents also testified that they had informed Defendant about her addiction and asked him to stop prescribing her these substances.” IG Ex. 9 at 3 (citation omitted); see also P. Ex. 2 at 21.

17. On February 7, 2020, the District Court entered a Judgment in a Criminal Case, which specified that Petitioner was found guilty on 14 counts (Counts 1s, 8s, 10s, 12s, 13s, 14s, 15s, 28s, 29s, 45s, 46s, 47s, 51s, 52s) of the Superseding Indictment for the “Unlawful distribution of Schedule II Controlled Substances” and “Unlawful distribution of Schedule IV Controlled Substances” in violation of 21 U.S.C. § 841(a)(1), (b)(1)(C), (2). IG Ex. 8 at 1-2; P. Ex. 2 at 20-21.
18. The Judgment in a Criminal Case specified that the District Court sentenced Petitioner to 41 months in prison. IG Ex. 8 at 3; P. Ex. 2 at 20-21.
19. On February 18, 2020, Petitioner appealed his criminal conviction. Ex. 2 at 21; P. Ex. 18 at 1, 4. However, on September 24, 2020, the United States Court of Appeals for the Third Circuit (Third Circuit) affirmed Petitioner’s conviction, and on December 8, 2020, the Third Circuit denied Petitioner’s request for a rehearing en banc. P. Ex. 18 at 5-6; P. Ex. 19.
20. On January 29, 2021, Petitioner filed an action in the District Court under 28 U.S.C. § 2255 challenging his sentence. Ex. 20. On February 18, 2021, the District Court stayed the case. P. Ex. 20 at 2. In a November 15, 2023, Memorandum Order, the District Court denied in part and dismissed in part Petitioner’s action brought under § 2255. P. Ex. 21.
21. On November 27, 2023, Petitioner appealed the District Court’s denial/dismissal of his § 2255 challenge to the Third Circuit. Ex. 22 at 3. The Third Circuit gave Petitioner an opportunity to apply for a certificate of appealability, and Petitioner filed such an application. P. Exs. 23-24. Petitioner also sought leave to file supplemental briefing concerning the application for a certificate of appealability. P. Ex. 25. On June 17, 2024, the Third Circuit granted Petitioner’s request to file the supplemental briefing but denied Petitioner’s request for a certificate of appealability. P. Ex. 22 at 3; P. Ex. 26. The Third Circuit also notified Petitioner that he could seek rehearing en banc by the Third Circuit. P. Ex. 27.

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22. On June 25, 2024, Petitioner requested that the Third Circuit clarify its order and petitioned for a rehearing en banc. Exs. 28-29. On July 9, 2024, the Third Circuit denied the petition for rehearing en banc. P. Ex. 22 at 4; P. Ex. 30.

Medical License Suspensions

23. Following the October 2, 2018, Indictment, on October 9, 2018, the Pennsylvania Bureau of Professional and Occupational Affairs petitioned the Board of Medicine to issue an Immediate Temporary Suspension of Petitioner’s medical license based on the Indictment. IG Ex. 11 at 7-11.
24. On October 9, 2018, the Board of Medicine temporarily suspended Petitioner’s medical license based on the charges in the Indictment and stated that a preliminary hearing would be held within 30 days before the Board of Medicine or a hearing examiner. IG Ex. 11 at 1-6; see also IG Ex. 10 at 32-33.
25. On December 12, 2018, the Board of Medicine accepted a consent agreement in which Petitioner’s suspension was stayed in favor of probation while Petitioner practiced with a monitor. IG Ex. 12 at 7.
26. On October 29, 2019, the Board of Medicine actively suspended Petitioner’s medical license after finding that Petitioner violated the terms of the probation. IG Ex. 12 at 7. Petitioner appealed this action, and, in a May 22, 2020 Adjudication and Order, a hearing examiner upheld the re-imposition of a suspension. Ex. 44. In doing so, the hearing examiner concluded that “[Petitioner] did not cooperate at all times with the Professional Health Monitoring Program (PHMP) with regard to the requirements of the [Consent Agreement and Order], thereby violating the [Consent Agreement and Order].” P. Ex. 44 at 9.
27. On March 4, 2020, the Pennsylvania Department of State petitioned the Board of Medicine to impose an automatic suspension on Petitioner. Ex. 42 at 9-17. On April 30, 2020, the Board of Medicine issued an Order of Automatic Suspension “based on [Petitioner’s] conviction in Federal court for unlawful distribution of a Schedule II controlled substance, an offense that if committed in [Pennsylvania] would be a felony under the Controlled Substance, Drug, Device and Cosmetic Act.” IG Ex. 12 at 5; P. Ex. 42 at 1-6.
28. Petitioner requested a hearing to dispute the automatic suspension. However, the hearing examiner did not hold a hearing because Petitioner did not respond to the motion from the government’s attorney that “[Petitioner’s] answer was no more than a collateral attack on his conviction.” IG Ex. 12 at 5-6; see also Ex. 43 at 3-5.

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29. On July 8, 2020, the hearing examiner issued an Adjudication and Order upholding the automatic suspension of Petitioner’s medical license. IG Ex. 12 at 4-21. The hearing examiner’s principal factual findings involved Petitioner’s conviction for the unlawful distribution of Scheduled II and Schedule IV controlled substances and the 41-month prison sentence. IG Ex. 12 at 7-8, 14-15. The hearing examiner’s principal conclusion of law was that: “[Petitioner’s] license to practice medicine and surgery is to be automatically suspended . . . because [Petitioner] was convicted in Federal court of unlawful distribution of Schedule II controlled substances, an offense that if committed in this Commonwealth would be a felony under the Drug Act.” IG Ex. 12 at 10, 14-16. The hearing examiner ordered Petitioner’s medical license retroactively suspended as of May 20, 2020. The hearing examiner stated that Petitioner’s license would remain suspended for at least ten years from the date of conviction (i.e., February 7, 2020). IG Ex. 12 at 18-19.
30. On December 1, 2020, the Board of Medicine issued a Final Order Making Hearing Examiner’s Adjudication and Order Final because Petitioner did not appeal the hearing examiner’s decision. IG Ex. 12 at 1-2.

VI. Conclusions of Law and Analysis

Exclusion

The Secretary of Health and Human Services (Secretary) must exclude an individual from participation in any federal health care program if that individual:

[H]as been convicted for an offense which occurred after August 21, 1996, under Federal or State law, of a criminal offense consisting of a felony relating to the unlawful manufacture, distribution, prescription, or dispensing of a controlled substance.

42 U.S.C. § 1320a-7(a)(4). This exclusion provision applies to, among others, health care practitioners. 42 C.F.R. § 1001.101(d)(1).

In the present case, the record supports the conclusion that all of the elements for a mandatory exclusion are met.

1. Petitioner was convicted of committing criminal offenses.

Under 42 U.S.C. § 1320a-7(i), an individual is “convicted” of a criminal offense when: (1) a judgment of conviction has been entered against him or her in a federal, state, or

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local court, regardless of whether an appeal is pending or the record of the conviction is expunged; (2) there is a finding of guilt by a court; (3) a plea of guilty or nolo contendere is accepted by a court; or (4) the individual has entered into a first offender program, deferred adjudication program, or other arrangement where a judgment of conviction is withheld.

In this case, as stated above in Findings of Fact 13 and 17, a jury found Petitioner guilty of 14 counts in the Superseding Indictment, and the District Court issued a judgment of conviction. Therefore, I conclude that Petitioner meets the statutory definition under 42 U.S.C. § 1320a-7(i)(1)-(2) of being “convicted” of a criminal offense for purposes of exclusion.

2. Petitioner was convicted of a felony.

Petitioner was convicted of violating 21 U.S.C. § 841(a)(1) and (b)(1)(C), (2). Section 841(b)(1)(C) specifies a sentence of not more than 20 years of imprisonment when the crime involves Schedule II controlled substances. Section 841(b)(2) specifies a sentence of not more than 10 years of imprisonment when the crime involves Schedule IV substances. Therefore, all of the offenses for which Petitioner was convicted are Class C felonies. 18 U.S.C. § 3559(a)(3).

3. Petitioner was convicted of a felony criminal offense relating to the unlawful manufacture, distribution, prescription, or dispensing of a controlled substance.

In order for a felony conviction to serve as a basis to exclude under 42 U.S.C. § 1320a‑7(a)(4), that conviction must have been for conduct relating to the unlawful manufacture, distribution, prescription, or dispensing of a controlled substance. For purposes of exclusion, the terms “related to” or “relating to” simply mean that there must be a nexus or common-sense connection. See Quayum v. U.S. Dep’t of Health & Human Servs., 34 F. Supp. 2d 141, 143 (E.D.N.Y. 1998); see also Friedman v. Sebelius, 686 F.3d 813, 820 (D.C. Cir. 2012) (describing the phrase “relating to” in another part of section 1320a-7 as “deliberately expansive words,” “the ordinary meaning of [which] is a broad one,” and one that is not subject to “crabbed and formalistic interpretation”) (internal quotation marks omitted).

Petitioner was convicted of 14 counts of violating 21 U.S.C. 841(a)(1), which makes it unlawful to knowingly or intentionally “manufacture, distribute, or dispense . . . a controlled substance.” Further, as indicated in Findings of Fact 5, 6, and 9, Petitioner’s criminal conduct involved prescribing hydrocodone (i.e., Norco / Vicodin), a Schedule II controlled substance, and tramadol (i.e. Ultram), a Schedule IV controlled substance in return for sexual favors. Therefore, I conclude that Petitioner’s criminal conduct directly relates to the prescription and dispensing of a controlled substance.

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4. The conduct for which Petitioner was convicted occurred after August 21, 1996.

The crimes that Petitioner was found guilty of committing occurred from 2014 to 2016. IG Ex. 3 at 2-3, 6-7. Therefore, Petitioner’s criminal conduct occurred after August 21, 1996.

5. Petitioner is or has been a health care practitioner.

Petitioner was licensed as a physician in Pennsylvania on June 19, 2009, and was licensed as a physician at the time of his criminal conduct. IG Ex. 12 at 7. Therefore, Petitioner is or has been a health care practitioner. See 42 C.F.R. § 1001.101(d)(1).

6. Petitioner must be excluded from participation in all federal health care programs for a minimum of five years.

As indicated above, the record conclusively shows that Petitioner was convicted, as that term is defined in 42 U.S.C. § 1320a-7(i), and that conviction meets all of the elements under 42 U.S.C. § 1320a-7(a)(4) for a mandatory exclusion. Therefore, Petitioner is subject to a mandatory five-year exclusion under 42 U.S.C. § 1320a-7(c)(3)(B).

Length of Exclusion

7. The IG has proven two aggravating factors that justify a length of exclusion beyond the minimum five-year requirement.

Although individuals excluded under 42 U.S.C. § 1320a‑7(a)(4) must be excluded for a minimum of five years, the statute does not preclude a longer term of exclusion. The applicable regulations provide a list of aggravating factors that may serve as the basis for extending an exclusion beyond five years. 42 C.F.R. § 1001.102(b). As explained below, the IG proved the existence of two aggravating factors listed in the regulations.

a. The District Court sentenced Petitioner to 41 months of incarceration.

The regulations provide the following as an aggravating factor: “The sentence imposed by the court included incarceration.” 42 C.F.R. § 1001.102(b)(5). As stated in Findings of Fact 15 and 18, Petitioner was sentenced to a term of imprisonment for 41 months. Therefore, I conclude that the IG proved this aggravating factor.

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b. The Board of Medicine suspended Petitioner’s medical license based on Petitioner’s criminal conviction.

The regulations provide the following as an aggravating factor:

The individual . . . has been the subject of any other adverse action by any Federal, State or local government agency or board if the adverse action is based on the same set of circumstances that serves as the basis for the imposition of the exclusion.

42 C.F.R. § 1001.102(b)(9).

As stated in Findings of Fact 24, 26, 29-30, the Board of Medicine imposed an Immediate Temporary Suspension of Petitioner’s medical license and later imposed an automatic suspension of Petitioner’s license for 10 years from the date of conviction. The Immediate Temporary Suspension was based solely on the Indictment, and the automatic suspension was based on the conviction that serves as the basis for the exclusion. Therefore, I conclude the IG proved this aggravating factor.

Petitioner filed supplemental documents showing that he recently requested reinstatement of his Pennsylvania medical license and that, after the Board of Medicine summarily denied the request, the Board of Medicine decided to consider the request more fully. P. Supp. Exs. 1-2. Petitioner asserts that the Board of Medicine’s actions are important because his “medical license suspension was a pivotal aggravating factor in the [IG’s] decision to exclude [Petitioner].” P. Supp. Mot. at 1-2. Petitioner argues that “this new information . . . directly impacts the [IG’s] rationale for exclusion.” P. Supp. Mot. at 2.

Petitioner’s supplemental submission does not undermine the exclusion in this case. The IG based its exclusion on Petitioner’s felony conviction (42 U.S.C. § 1320a-7(a)(4)) and not on the suspension of Petitioner’s medical license (42 U.S.C. § 1320a-7(b)(4)). IG Ex. 1.

The IG only considered the license suspension as an aggravating factor to extend the length of exclusion beyond five years. IG Ex. 1; 42 C.F.R. § 1001.102(b)(9). However, the supplemental exhibits do not impact this aggravating factor because the Board of Medicine is only deciding whether to reinstate Petitioner’s license. Even if the Board of Medicine were to void the original suspension, as explained below, the IG’s other aggravating factor in this case, i.e., Petitioner’s incarceration, is sufficient to justify the seven-year exclusion.

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8. Petitioner did not prove the existence of any mitigating factors that would justify a reduction in the length of exclusion imposed by the IG.

When there are aggravating factors supporting an exclusion for more than five years, an excluded individual may show that one or more mitigating factors listed in the regulations justify a reduction in the length of exclusion. 42 C.F.R. § 1001.102(c). Petitioner did not assert or prove that any of the mitigating factors listed in the regulations are present in this case. See P. Br. at 66-67.

9. The seven-year length of Petitioner’s exclusion is not unreasonable.

When considering the length of exclusion, “[t]he evaluation does not rest on the specific number of aggravating or mitigating factors or any rigid formula for weighing those factors, but rather on a case-specific determination of the weight to be accorded each factor based on a qualitative assessment of the circumstances surrounding the factors in that case.” Farzana Begum, M.D., DAB No. 2726 at 2 (2016). Further, the general purpose of an exclusion under 42 U.S.C. § 1320a-7 is “to protect federal health care programs and the programs’ beneficiaries and recipients from untrustworthy providers.” Susan Malady, R.N., DAB No. 1816 at 4 (2002). Ultimately, I must decide whether the seven-year length of exclusion is unreasonable (i.e., is it within a reasonable range for the length of exclusion based on the relevant factors). 42 C.F.R. § 1001.2007(a)(1)(ii); 57 Fed. Reg. 3298, 3321 (Jan. 29, 1992).

In this case, Petitioner was convicted of 14 counts of unlawfully prescribing controlled substances for an individual, over the course of approximately two years, in exchange for sexual favors. The Third Circuit summarized Petitioner’s criminal conduct as follows:

In June of 2014 TS went to Shaker Urgent Care because she was suffering from a migraine. She met with a physician’s assistant, who prescribed her “a relatively small quantity” of Fioricet, a potentially addictive medication. (App. at 533.) TS returned to Shaker Urgent Care about two weeks later, meeting with Shaker himself. During that visit, Shaker tripled her previous Fioricet prescription and also prescribed Percocet, a highly addictive opioid medication. TS returned to Shaker Urgent Care twice more over the next few months, during which visits Shaker prescribed ever-increasing amounts of addictive drugs.

TS’s visits to Shaker were so frequent that he ultimately became her primary care physician. Soon after, Shaker obtained TS’s contact information from her patient chart and started texting her. They quickly began a sexual relationship.

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The relationship continued for years, during which time Shaker continued to prescribe TS large quantities of pain medication. He continued the prescriptions even when contacted by another doctor, who had performed surgery on TS, informing him that TS was doing well, feeling little pain, and didn’t feel that she needed medication any longer. Drug addicted and with a broken marriage, TS eventually left home and ended up living in a crack house.

United States v. Shaker, 827 Fed. App’x 204, 206 (3d Cir. 2020).

The IG identified two aggravating factors that support a lengthened exclusion.

Petitioner’s incarceration for 41 months is particularly aggravating. A prison sentence of as little as nine months is considered substantial for exclusion purposes. Jason Hollady, M.D., DAB No. 1855 at 12 (2002). Petitioner’s sentence is more than four times longer than the nine months imprisonment. It is also significant that the 41-month sentence was “the highest end of the [sentencing] guidelines.” IG Ex. 10 at 7.

Because the District Court imposed a long period of incarceration, the reasons the court did so are particularly important. The court stated the following during the sentencing hearing:

Dr. Shaker, you have abused your position as a doctor, a trusted healer, by feeding the addiction of a vulnerable woman for your personal gratification. Your actions and your utter failure to appreciate your wrongdoing, particularly amid the opioid crisis in America, and, indeed, in Western Pennsylvania, are troubling. Your objections to the presentence report and your conduct here today demonstrates to me that you continue to refuse to accept responsibility for the very serious crimes of which you were convicted. I do hope that at some point you come to realize how devastating your actions were to another individual and the sentence imposed today reinforces the gravity of your actions.

IG Ex. 10 at 53. Therefore, Petitioner’s lengthy incarceration was premised, at least in part, on Petitioner’s abuse of his position as a physician, failure to appreciate wrongdoing that contributed to the opioid crisis, refusal to accept responsibility for his serious crimes, and a lack of realization of the grave harm he caused another person. This lengthy sentence, and the basis for the lengthy sentence, fully supports the increased length of exclusion by two years.

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In addition to the lengthy sentence of incarceration, Petitioner’s medical license suspension also supports an increased length of exclusion. As indicated in Findings of Fact 23-30, Petitioner’s crimes were sufficiently detrimental under Pennsylvania law that Petitioner’s mere Indictment for those crimes resulted in an Immediate Temporary Suspension of his license. Although the Board of Medicine allowed Petitioner to resume practice while his criminal case was being litigated, the Board of Medicine again imposed the temporary suspension based on Petitioner’s failure to comply with the terms of probation. Finally, following Petitioner’s conviction, a mandatory 10-year suspension of Petitioner’s medical license was imposed because Petitioner was convicted of crimes that are the equivalent of felonies under the Pennsylvania Drug Act. IG Ex. 12 at 16. The adverse actions (i.e., the suspensions) taken by the Board of Medicine show that Petitioner’s crimes were extremely serious necessitating a longer exclusion.

Further, because trustworthiness to participate in federal health care programs is a major consideration as to the length of exclusion, it is important to note that the District Court found Petitioner to be particularly untrustworthy based on his actions during the criminal proceeding. In responding to Petitioner’s motion for acquittal, the District Court found, by a preponderance of the evidence, that Petitioner committed perjury. IG Ex. 9 at 3 n.1. The District Court also stated: “Throughout the course of trial, and continuing through sentencing, Defendant has repeatedly denied wrongdoing, refused to accept responsibility for his actions and lied to the Court.” IG Ex. 9 at 3. Finally, during sentencing, the District Court stated: “The court agrees with the government that defendant willfully impeded the administration of justice by giving dishonest testimony at trial, as described above and in detail by the government in its sentencing memorandum.” IG Ex. 10 at 18.

The sole purpose of the exclusion is to protect federal health care programs from those who would commit fraud on those programs or other crimes against beneficiaries. Manocchio v. Kusserow, 961 F.2d 1539, 1541-42 (11th Cir. 1992) (exclusions are remedial and not punitive). Therefore, the length of exclusion is to ensure the well-being of federal health care programs and its beneficiaries. Adding two additional years to the minimum length of exclusion is fully supported by the record and serves the remedial purpose of protecting Medicare program beneficiaries.

Petitioner’s Collateral Attacks

10. Petitioner’s arguments are impermissible collateral attacks or otherwise lack merit.

In an extremely lengthy brief, Petitioner posits multiple reasons why he was not convicted of a criminal offense. However, as I discussed at the prehearing conference, these attacks are impermissible in this forum. 42 C.F.R. § 1001.2007(d); see Travers v. Shalala, 20 F.3d 993, 998 (9th Cir. 1994). Although Petitioner attempts to re-write

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various court orders to say things they do not say, all of Petitioner’s arguments ultimately attack the validity of his criminal conviction. I discuss them below.

Petitioner argues that “it is clear from the pre-trial proceedings of this [criminal] case is clear deviation from the standard of the fair trial as per U.S. constitution.” P. Br. at 4. Petitioner claims that the criminal case docket sheet proves this when it indicates the District Court denied all pre-trial motions as moot, showing that there should have been no additional proceedings when all matters are considered moot. P. Br. at 4-5; P. Ex. 2. As Petitioner argues:

The question here is, why the court and parties proceeded with a trial they knew the outcome isn’t going anywhere and not binding, and the only answer of this question is, the continuation is nothing but continue ongoing investigation based on the ongoing process and the later outcome of the appeals and much more which I will briefly address throughout this briefing, and here is some facts and law support that notion, continuing criminal proceedings after pre-trial motions are deemed moot can be considered equivalent to continuing investigations, rather than a legitimate trial.

P. Br. at 6. Based on this, Petitioner asserts that he is not collaterally attacking his criminal conviction but showing that a conviction does not exist based on the “mootness doctrine.” P. Br. at 8.

Petitioner misunderstands the actions of the District Court. The District Court did not dismiss the criminal charges against him as moot but rather held a jury trial to determine his innocence or guilty. Petitioner’s argument, that the conviction is void because the District Court had already dismissed the case for mootness, is an impermissible collateral attack on the validity of his conviction.

Petitioner also argues that a background check on September 14, 2022, by a company called Catapult Services Corporation, shows that a “Statewide Criminal Search – PA” produced “No Record Found Felony and Misdemeanor,” thus proving there is no conviction. P. Br. at 8-9; P. Ex. 3 at 2. The results of a background check made by a private company do not prove that Petitioner was not convicted of a crime. Further, it is not clear if this check is limited to state law convictions or includes federal ones.

Petitioner also asserts that criminal investigators used an incorrect social security number (SSN) when processing his arrest and that the District Court knew this and allowed his criminal case to proceed with an incorrect SSN. P. Br. at 9. In briefing, Petitioner provided his correct SSN and the erroneous one (which is off by one digit) used on

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documentation in his criminal case. P. Br. at 10. Petitioner also provided a chronology and documents concerning the use of the incorrect SSN in his criminal case. P. Br. at 9-15; P. Exs. 4-13. Petitioner believes that the District Court’s use of an incorrect SSN could void the criminal proceedings, undermine the District Court’s jurisdiction, and lead to dismissal or reversal of the criminal conviction. P. Br. at 15-18.

At its core, Petitioner’s argument concerning his SSN is a collateral attack on the validity of his criminal conviction because Petitioner believes that the District Court’s use of an incorrect SSN on court documents invalidates his entire criminal proceeding. Further, while his case was still pending before the District Court, Petitioner refused to cooperate and correct the typographical mistake that was made by government officials.

The District Court noted at the sentencing hearing that Petitioner had objected to the incorrect SSN on various documents, but that Petitioner had not provided written documentation to support a different SSN. IG Ex. 10 at 3, 5. The District Court asked Petitioner’s counsel if Petitioner intended to submit a Social Security card, to which counsel responded: “Dr. Shaker has declined to provide me with his Social Security card.” IG Ex. 10 at 11. Petitioner addressed the court on this issue as follows:

THE DEFENDANT: How can you convict someone with a wrong Social Security number?

THE COURT: Well, do you have another Social Security number?

THE DEFENDANT: The federal government doesn’t know my Social Security number when they came and arrest me?

THE COURT: I’m not here to argue with you today, Dr. Shaker.

THE DEFENDANT: My Social Security number on my arrest warrant, when they fingerprint me, this man sitting here (indicating), he arrested me, he didn’t even look at my Social Security number with the arrest.

THE COURT: Do you have another Social Security number that you care to share with us?

THE DEFENDANT: I have my Social Security number. I know it.

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THE COURT: Okay. If you would like to show that to the probation officer, we can have that corrected in the record.

THE DEFENDANT: Why do I have to correct it because I disagree with all the sentencing?

THE COURT: Well, okay. If you don’t wish to correct it, that will just be the Social Security number on the file for you.

THE DEFENDANT: That is not mine.

THE COURT: Stop. Dr. Shaker, we are not here to argue with you.

THE DEFENDANT: I want to point out one thing. To arrest me, to try me, to convict me, to sentence me with wrong Social Security number, this mean one thing. You got the wrong person. This is true. The one sitting here is the wrong person, the wrong person. Everyone in this room destroyed his life. Everyone in this room destroyed his life and this man sitting here (indicating).

THE COURT: Dr. Shaker, you will be allowed an opportunity to speak your mind in due time. This is not the time for that. Do you have any other issues with the presentence report?

THE DEFENDANT: I disagree with it. I only agree with one thing. I’m innocent. I must be acquitted.

THE COURT: Okay. Very good. Mr. Gurzo, you don’t have any information about the Social Security number, do you?

MR. GURZO: No, Your Honor.

IG Ex. 10 at 12-13. Later in the sentencing hearing, Petitioner raised his SSN issue again:

You know how many typo issues I have in my case. I cannot even count them, including my Social Security number. They are asking me to provide a copy of my Social Security right before they throw me in jail. They arrested me. They

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investigated me. You destroyed my life, and you still don’t know my right Social Security number

IG Ex. 10 at 46.

It is clear from the sentencing hearing that Petitioner was in fact the individual who was charged and convicted of the offenses in the Superseding Indictment. A typographical error in Petitioner’s SSN on the court’s paperwork does not prove that Petitioner was never convicted of a crime.

Petitioner also asserts that there is no victim related to his crime and that the District Court discussed a victim in contradiction to the criminal case record. P. Br. at 18-19; P. Ex. 14. Petitioner misunderstands the use of the term “victim” in the court documents he references. In any event, this argument yet again is an impermissible collateral attack on his conviction.

Petitioner also discussed a civil action he filed in the District Court under 28 U.S.C. § 2255 to challenge the sentence that the District Court imposed. P. Br. at 29. Findings of Fact 20 through 22 indicate that the District Court denied Petitioner’s action in part and dismissed it in part, and that the Third Circuit denied Petitioner’s appeal of the District Court’s actions and refused to rehear Petitioner’s appeal en banc. Despite the clear documentation showing that Petitioner lost his § 2255 action to challenge the sentence imposed on him, Petitioner instead argues that the Third Circuit transformed his criminal case into a civil case, thus showing that his criminal case was now moot. P. Br. at 38. This is not correct. Again, this is a collateral attack on the validity of Petitioner’s conviction. In addition, Petitioner’s documents actually show that the Third Circuit, for a second time, did not find a reason to reverse Petitioner’s conviction or sentence.

Next, Petitioner argues that his conviction was dismissed during a proceeding initiated by his probation officer. Following release from prison, Petitioner’s probation officer accused Petitioner before the District Court of failing to comply with the terms for supervised release; however, that matter was settled and dismissed. P. Br. at 44-49; P. Exs. 35-40. From this, Petitioner draws the conclusion that the dismissal “renders this entire vicious process null as the rest of the case.” P. Br. at 49.

As with other court orders, Petitioner misreads the District Court order, which merely grants the dismissal of the Probation Officer’s petition for an arrest warrant for Petitioner based on the following:

During a court hearing on October 23, 2024, the Probation Office agreed to withdraw the petition [to issue a warrant for Petitioner’s arrest], dated August 30, 2024, if the [Petitioner] agreed to abide by all conditions set forth in the Judgment of

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Commitment Order dated February 7, 2020. Under oath the [Petitioner] agreed to abide by all mandatory, standard, and special conditions set forth within this order.

P. Ex. 40 at 1; see also P. Ex. 37. This order has no effect on whether Petitioner was convicted of offenses that require exclusion. Again, Petitioner’s argument serves as a collateral attack on the validity of his conviction.

Finally, Petitioner argues that an ALJ with the Pennsylvania Department of Health and Human Services, who is adjudicating Petitioner’s preclusion from participating in the Pennsylvania Medicaid program, granted a stay in that proceeding because the ALJ “agreed that, the entire criminal proceedings against [Petitioner] are unlawful, corrupt and unconstitutional.” P. Br. at 21-22; see also P. Exs. 15, 17. According to documents that Petitioner submitted, on May 6, 2024, the Pennsylvania ALJ stayed the appeal of the preclusion from the Pennsylvania Medicaid program for 180 days while Petitioner’s appeal to the Third Circuit, concerning his § 2255 action, was being decided. P. Ex. 16. The ALJ stated nothing about the merits of Petitioner’s criminal conviction. Further, in a November 8, 2024 Order, the Pennsylvania ALJ set a dispositive motion filing schedule for the parties. P. Ex. 41. Therefore, the Pennsylvania ALJ has now continued to move Petitioner’s case forward.

Even if the Pennsylvania ALJ believes that Petitioner’s criminal conviction was incorrect and reverses the Pennsylvania Medicaid preclusion, such a decision would not have any direct bearing on the present case or undermine the legitimacy of Petitioner’s criminal conviction.

VII. Conclusion

I affirm the IG’s determination that Petitioner must be excluded from participation in all federal health care programs for five years under 42 U.S.C. § 1320a‑7(a)(4). I also uphold the IG’s decision to lengthen Petitioner’s exclusion by an additional two years to a seven-year exclusion.