Samirkumar Shah, M.D., CR6291 (2023)

DECISION

Petitioner, Samirkumar Shah, M.D., is excluded from participating in Medicare, Medicaid, and all federal health care programs pursuant to section 1128(a)(1) and (3) of the Social Security Act (Act) (42 U.S.C. § 1320a-7(a)(1), (3)), effective July 20, 2022.  Petitioner’s exclusion for the minimum period of five years is required by section 1128(c)(3)(B) of the Act (42 U.S.C. § 1320a-7(c)(3)(B)).  Exclusion for an additional 22 years, for a total minimum exclusion of 27 years,¹  is not unreasonable based on the presence of three aggravating factors and the absence of any mitigating factors. 

Page 2

   I. Background

The Inspector General of the United States Department of Health and Human Services (IG) notified Petitioner by letter dated June 30, 2022, that he²  was excluded from participation in Medicare, Medicaid, and all federal health care programs for 27 years.  The IG cited section 1128(a)(1) and (3) of the Act as the authority for Petitioner’s exclusion based on his conviction in the United States District Court for the Western District of Pennsylvania (district court).  The IG notified Petitioner that his district court conviction was a basis for exclusion pursuant to section 1128(a)(1) of the Act because the criminal offense of which he was convicted was related to the delivery of an item or service under Medicare or a state health care program.  The IG also notified Petitioner that his district court conviction was a basis for exclusion pursuant to section 1128(a)(3) of the Act.  Section 1128(a)(3) of the Act requires exclusion if one is convicted under federal or state law of a felony criminal offense that was committed after August 21, 1996, and was related to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct in connection with the delivery of a health care item or service or with respect to any act or omission in a health care program other than Medicare or Medicaid operated or funded by the federal, a state, or a local government agency.  IG Exhibit (IG Ex.) 1. 

Petitioner timely filed a request for hearing (RFH) on August 22, 2022.  On August 31, 2022, the case was assigned to me to hear and decide.  I convened a telephone prehearing conference on November 29, 2022, the substance of which is memorialized in my Prehearing Conference Order and Schedule for Filing Briefs and Documentary Evidence issued on November 30, 2022 (Prehearing Order). 

On January 30, 2023, the IG filed a motion for summary judgment with supporting brief, and IG Exs. 1 through 7.  On March 28, 2023, Petitioner filed a memorandum in opposition to the IG’s motion for summary judgment (P. Br.) and Petitioner’s exhibits (P. Exs.) 1 through 3.  The IG waived a reply on April 6, 2023. 

Neither party objected to the opposing party’s exhibits.  Accordingly, IG Ex. 1 through 7 and P. Ex. 1 through 3 are admitted.  

Page 3

   II. Discussion

A.  Applicable Law

Section 1128(f) of the Act (42 U.S.C. § 1320a-7(f)) establishes Petitioner’s right to a hearing by an administrative law judge (ALJ) and judicial review of the final action of the Secretary of Health and Human Services (the Secretary). 

Pursuant to section 1128(a)(1) of the Act, the Secretary must exclude from participation in any federal health care program any individual convicted under federal or state law of, among other things, a criminal offense related to the delivery of an item or service under Medicare or a state health care program.  Act § 1128(a)(1).  The Secretary has promulgated regulations implementing this provision of the Act.  42 C.F.R. § 1001.101(a). 

Pursuant to section 1128(a)(3) of the Act, the Secretary must exclude from participation in any federal health care program: 

Any individual or entity that has been convicted for an offense which occurred after [August 21, 1996], under Federal or State law, in connection with the delivery of a health care item or service or with respect to any act or omission in a health care program (other than those specifically described in [section 1128(a)(1)]) operated by or financed in whole or in part by any Federal, State, or local government agency, of a criminal offense consisting of a felony relating to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct. 

Act § 1128(a)(3); 42 C.F.R. § 1001.101(c).  

Pursuant to section 1128(i) of the Act (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 them in a federal, state, or local court 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 no contest is accepted by a court; or (4) the individual has entered into any arrangement or program where judgment of conviction is withheld. 

Section 1128(c)(3)(B) of the Act provides that an exclusion imposed under section 1128(a) of the Act will be for a period of not less than five years.  42 C.F.R. § 1001.102(a).  The Secretary has published regulations that establish aggravating factors that the IG may consider in extending the period of exclusion beyond the minimum five-

Page 4

year period, as well as mitigating factors that may be considered only if the minimum five year period is extended. 42 C.F.R. § 1001.102(b), (c).

In this proceeding, the standard of proof is a preponderance of the evidence.  42 C.F.R. § 1001.2007(c).  Petitioner bears the burden of proof and the burden of persuasion on any affirmative defenses or mitigating factors, and the IG bears the burden on all other issues.  42 C.F.R. § 1005.15(b), (c); Prehearing Order ¶ 4.  There may be no collateral attack of the conviction that is the basis for the exclusion.  42 C.F.R. § 1001.2007(d). 

B.  Issues

The Secretary has by regulation limited my scope of review to two issues:  

Whether the IG has a basis for excluding an individual or entity from participating in Medicare, Medicaid, and all other federal health care programs; and

Whether the length of the exclusion is unreasonable. 

42 C.F.R. § 1001.2007(a)(1). 

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

My conclusions of law are set forth in bold text followed by my findings of fact and analysis. 

1.  Petitioner timely filed his hearing request and I have jurisdiction. 

There is no dispute that Petitioner timely requested a hearing and that I have jurisdiction pursuant to section 1128(f) of the Act and 42 C.F.R. pt. 1005. 

2.  Summary judgment is appropriate in this case. 

Pursuant to section 1128(f) of the Act, a person subject to exclusion has a right to reasonable notice and an opportunity for a hearing.  The Secretary has provided by regulation that a sanctioned party has the right to a hearing before an ALJ, and both the sanctioned party and the IG have a right to participate in the hearing.  42 C.F.R. § 1005.2‑.3.  Either or both parties may choose to waive appearance at an oral hearing and to submit only documentary evidence and written argument for my consideration.  42 C.F.R. § 1005.6(b)(5).  An ALJ may also resolve a case, in whole or in part, by summary judgment.  42 C.F.R. § 1005.4(b)(12). 

Page 5

Summary judgment is appropriate in an exclusion case when there are no disputed issues of material fact and when the undisputed facts, clear and not subject to conflicting interpretation, demonstrate that one party is entitled to judgment as a matter of law.  Tanya A. Chuoke, R.N., DAB No. 1721 (2000); David A. Barrett, DAB No. 1461 (1994); Robert C. Greenwood, DAB No. 1423 (1993); Thelma Walley, DAB No. 1367 (1992); Catherine L. Dodd, R.N., DAB No. 1345 (1992); John W. Foderick, M.D., DAB No. 1125 (1990).  When the undisputed material facts of a case support summary judgment, there is no need for a full evidentiary hearing, and neither party has the right to one.  Surabhan Ratanasen, M.D., DAB No. 1138 (1990); Foderick, DAB No. 1125.  In opposing a properly supported motion for summary judgment, the nonmovant must allege facts that show there is a genuine dispute of material fact that affects the proponent’s prima facie case or that might establish a defense.  The nonmovant may not rely upon mere allegations or denials to defeat a properly supported motion for summary judgment.  To defeat a properly supported motion for summary judgment and proceed to a trial, the nonmovant must show there is a genuine dispute as to a material fact that requires determination by the fact finder.  On summary judgment, the judge does not weigh the evidence or attempt to determine the truth.  Rather, the judge accepts the nonmovant’s evidence as true and draws all permissible inferences in the nonmovant’s favor.  Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-57 (1986). 

There is no genuine dispute of material fact in this case.  Petitioner does not dispute that the IG properly excluded him under section 1128(a)(1) and (3) of the Act based on his conviction in the district court.  P. Br. at 4.  Petitioner also does not dispute that the IG properly found three aggravating factors.  Petitioner does not argue that there are any mitigating factors that the IG failed to consider.  P. Br. at 4-5.  Petitioner argues the IG did not properly weigh the aggravating factors and that there are equitable considerations that require that the period of Petitioner’s exclusion be reduced.  P. Br. at 5-7.  Petitioner’s arguments must be resolved against him as matters of law.  I conclude that summary judgment in favor of CMS is appropriate and that the 27-year exclusion is reasonable as a matter of law. 

3.  Section 1128(a)(1) and (3) of the Act require Petitioner’s exclusion from participation in Medicare, Medicaid, and all other federal health care programs. 

Petitioner concedes that the IG properly excluded him under section 1128(a)(1) and (3) due to his conviction in the district court.  P. Br. at 4. 

a.  Facts

On May 17, 2016, a federal grand jury indictment of Petitioner was filed in the district court.  Petitioner was charged with two counts of health care fraud in violation of 18 U.S.C. § 1347.  IG Ex. 2.  The indictment alleged that, between January 2008 and

Page 6

December 2014, Petitioner, a cardiologist, engaged in a scheme to defraud health care benefit programs, including Medicare, Medicaid, Highmark Blue Cross Blue Shield, UPMC Health Plan, and Gateway Insurance Company, for medically unnecessary treatments known as external counterpulsation (ECP).  ECP involves the use of a specialized bed equipped with pressure cuffs that exert pressure to patients’ lower extremities to increase blood flow to the heart.  Insurers will only reimburse practitioners for ECP treatments provided to patients that suffer from disabling angina and only if a physician supervises the treatment.  IG Ex. 2 at 4-5 ¶¶ 10-12.  

On June 14, 2019, a jury found Petitioner guilty of both counts of knowingly and willfully executing and attempting to execute a scheme to defraud health care benefit programs, in violation of 18 U.S.C. § 1347, from about January 2008 through December 2014.  IG Ex. 3.  On August 5, 2021, the district court entered judgment that Petitioner was guilty of both felony counts.  The district court sentenced Petitioner to 78 months incarceration for each count to run concurrently.  IG Ex. 4 at 1-2; IG Ex. 6.  The district court ordered supervised release upon completion of Petitioner’s imprisonment for a term of three years for each count to run concurrently.  IG Ex. 4 at 3; IG Ex. 6.  The district court further ordered Petitioner to pay restitution of $1,234,983.60 to Medicare, Gateway Medicaid, Highmark Blue Cross Blue Shield, and UPMC’s Fraud, Waste, and Abuse Unit.  IG Ex. 4 at 6-7; IG Ex. 6. 

b.  Analysis

The IG cites section 1128(a)(1) and (3) of the Act as the basis for Petitioner’s mandatory exclusion.  Petitioner concedes that the IG had a basis to exclude him from Medicare, Medicaid, and all federal healthcare programs based on his conviction pursuant to section 1128(a)(1) and (3) of the Act.  P. Br. at 4 (“Petitioner concedes that the IG properly excluded him under section 1128(a)(1) and 1128(a)(3) of the Act.”). 

I conclude that all elements necessary to trigger mandatory exclusion pursuant to section 1128(a)(1) and (3) of the Act are satisfied in this case.  Accordingly, the IG had a basis to exclude Petitioner.  

4.  Section 1128(c)(3)(B) of the Act requires a minimum period of exclusion of five years for an exclusion under Section 1128(a) of the Act. 

I have concluded that a basis exists to exclude Petitioner pursuant to section 1128(a)(1) and (3) of the Act.  Therefore, the IG must exclude Petitioner for the minimum period of five years required by Congress in section 1128(c)(3)(B) of the Act.  Petitioner acknowledges that there is no review of the reasonableness of the five-year period of exclusion or any discretion to impose a lesser period.  42 C.F.R. §§ 1001.102(a), 1001.2007(a)(2); P. Br. at 4. 

Page 7

5.  Three aggravating factors established by 42 C.F.R. § 1001.102(b) exist in this case that may be relied upon by the IG to extend the period of exclusion beyond five years and no mitigating factors established by 42 C.F.R. § 1001.102(c) exist. 

The IG cited three aggravating factors described as follows in extending Petitioner’s period of exclusion from the mandatory minimum five-year exclusion to 27 years.  The IG considered no mitigating factors.  IG Ex. 1 at 1-2.  Petitioner does not dispute that the IG properly found that there were three aggravating factors and no mitigating factors.  P. Br. at 4 (“Petitioner also recognizes that pursuant to 42 C.F.R. §§ 1001.102(b), three aggravating factors exist.”); P. Br. at 5 (“Petitioner is unable to avail himself of any mitigating factors.”).  Accordingly, there is no dispute that the IG considered all applicable aggravating factors and properly found that there were no mitigating factors. 

a.  Petitioner concedes that, as found by the IG, his criminal offenses resulted in a loss to one or more entities of $50,000 or more.  42 C.F.R. § 1001.102(b)(1). 

The IG may consider as an aggravating factor justifying a period of exclusion over five years that the acts for which one was convicted caused, or were intended to cause, a loss to the government agency or program of $50,000 or more.  42 C.F.R. § 1001.102(b)(1).  Petitioner was ordered by the district court to pay restitution to Medicare, Gateway Medicaid, Highmark Blue Cross Blue Shield, and UPMC’s Fraud, Waste, and Abuse Unit, in the amount of $1,234,983.60.  IG Ex. 4 at 6-7; IG Ex. 6.  The Board has previously accepted that an amount ordered as restitution constitutes proof of the amount of financial loss.  Jeremy Robinson, DAB No. 1905 at 11 (2004); Craig Richard Wilder, DAB No. 2416 at 9 (2011); Juan de Leon, Jr., DAB No. 2533 at 5 (2013); Laura Leyva, DAB No. 2704 at 9 (2016). 

Petitioner does not dispute the existence of this aggravating factor or the amount of loss his offenses caused or were intended to cause.  I conclude this aggravating factor exists and that the IG could consider this factor to determine the period of exclusion. 

b.  Petitioner concedes that, as found by the IG, the criminal acts for which he was convicted were committed over a period of one year or more.  42 C.F.R. § 1001.102(b)(2). 

The fact that acts that resulted in the conviction that occur over a year or more may be considered by the IG to extend a petitioner’s period of exclusion beyond the five-year minimum.  42 C.F.R. § 1001.102(b)(2).  In the present case, it is undisputed that the jury found that Petitioner committed his fraudulent scheme from about January 2008 through

Page 8

December 2014.  IG Ex. 3 at 5.  This aggravating factor is undisputed and could be considered by the IG to extend the period of exclusion. 

c.  Petitioner concedes that, as found by the IG, he was sentenced to be incarcerated.  42 C.F.R. § 1001.102(b)(5). 

Under 42 C.F.R. § 1001.102(b)(5), the IG may extend the period of exclusion beyond the mandatory minimum five year period when the sentence imposed by the court includes incarceration.  On August 5, 2021, the district court sentenced Petitioner to 78 months in prison for each of the two counts for which he was found guilty, to be served concurrently.  IG Ex. 4 at 2.  Petitioner does not dispute the existence of this aggravating factor and I conclude that this aggravating factor could be considered by the IG. 

6.  Exclusion for 27 years is not unreasonable in this case.  

Petitioner does not dispute the existence of the three aggravating factors or that he cannot establish a mitigating factor not considered by the IG.  However, Petitioner argues that the IG improperly weighed the three aggravating factors when determining to impose a 27-year exclusion.  P. Br. at 5-8. 

According to the Secretary’s regulations an ALJ is supposed to determine whether the length of exclusion imposed is “unreasonable.”  42 C.F.R. § 1001.2007(a)(1)(ii).  The Board, however, has made clear that the role of the ALJ in exclusion cases is to conduct a de novo review of the facts related to the basis for the exclusion and the existence of aggravating and mitigating factors identified at 42 C.F.R. § 1001.102 and to determine whether the period of exclusion imposed by the IG falls within a reasonable range.  Juan de Leon, Jr., DAB No. 2533 at 3; Craig Richard Wilder, DAB No. 2416 at 8; Joann Fletcher Cash, DAB No. 1725 at 17 n.6 (2000).  The Board explained that, in determining whether a period of exclusion is “unreasonable,” the ALJ is to consider whether such period falls “within a reasonable range.”  Cash, DAB No. 1725 at 17 n.6.  Pursuant to 42 C.F.R. § 1005.20(b), an ALJ is authorized to affirm, increase, or reduce the period of exclusion imposed by the IG.  However, the Board cautions that whether the ALJ thinks the period of exclusion is too long or too short is not the issue.  The ALJ may not substitute his or her judgment for that of the IG and may only change the period of exclusion in limited circumstances.  The Board has tightly restricted my authority under the applicable regulation to judge the reasonableness of the period of exclusion as shown by two Board decisions. 

In John (Juan) Urquijo, DAB No. 1735 (2000), the Board made clear that, if the IG considers an aggravating factor to extend the period of exclusion and that factor is not later shown to exist on appeal, or if the IG fails to consider a mitigating factor that is shown to exist, then the ALJ may make a decision as to the appropriate extension of the period of exclusion beyond the minimum.  In Gary Alan Katz, R.Ph., DAB No. 1842

Page 9

(2002), the Board suggested that when it is found that an aggravating factor considered by the IG is not proved before the ALJ, then some downward adjustment of the period of exclusion should be expected absent some circumstances that indicate no such adjustment is appropriate.  

Based on my de novo review, I conclude that exclusion pursuant to section 1128(a)(1) and (3) of the Act is required.  The undisputed evidence establishes the three aggravating factors that the IG relied on to impose the 27-year exclusion.  Petitioner has shown no genuine dispute of material fact or presented evidence that triggers an inference in his favor that the IG considered an aggravating factor that did not exist or that the IG failed to consider any mitigating factor authorized by 42 C.F.R. § 1001.102(c).  Accordingly, summary judgment is appropriate as I have no authority to reassess the period of exclusion imposed in this case.  Furthermore, a period of exclusion of 27 years is in a reasonable range and not unreasonable considering the existence of three aggravating factors and no mitigating factor.  Accordingly, I conclude that no change in the period of exclusion is permissible or appropriate.  

Petitioner argues that the IG did not properly weigh the aggravating factors when imposing the 27-year exclusion upon Petitioner.  Specifically, Petitioner argues that the aggravating factors do not support an exclusion that is “more than five times as long as the mandatory minimum.” P. Br. at 6.  I disagree.  In my opinion, each of the aggravating factors justifies a significant increase in the period of exclusion from the five-year minimum required by the Act.  The district court ordered restitution that is 24 times the amount of loss or intended loss that the IG may consider an aggravating factor.  The magnitude of the restitution reflects the financial impact of Petitioner’s criminal offenses recognized by the district court.  Petitioner’s acts occurred over a period seven times longer than the period that may be considered as aggravating.  Finally, Petitioner was sentenced to 78 months in prison for each of the two counts for which he was found guilty; a substantial amount of time that reflects his criminality in the eyes of the district court and justifies a significant increase from the minimum exclusion of five years.  The evidence shows the IG considered and weighed the undisputed aggravating factors when imposing a 27-year exclusion.  Substituting my discretion for that of the IG is not permitted based on prior Board decisions. 

Petitioner argues that the IG’s 27-year exclusion is tantamount to a permanent exclusion given Petitioner’s current age of 60.  P. Br. at 6.  Petitioner cites no authority to support a position that the IG does not have discretion under section 1128(c)(3) of the Act and 42 C.F.R. § 1001.102 to impose a permanent exclusion.  However, the fact is that the IG

Page 10

did not impose a permanent exclusion but, rather, a 27-year exclusion clearly reflecting that the IG knew the difference and exercised discretion.³ 

Petitioner argues that the 27-year exclusion prevents him from paying his court-ordered restitution.  P. Br. at 6.  Put another way, Petitioner is arguing that he needs to be able to bill Medicare and Medicaid so that he can afford to reimburse Medicare and Medicaid for his years-long, multimillion-dollar fraud.  Whether Petitioner pays the restitution ordered by the district court is a matter between Petitioner and the district court.  Consideration of Petitioner’s ability to pay restitution is not a basis upon which I am permitted to overturn the IG’s discretion. 

Petitioner argues that exclusion for 27 years is punitive rather than remedial.  P. Br. at 5-7.  Exclusions imposed by the IG are civil sanctions, remedial in nature and not punitive and criminal.  Because exclusions are remedial sanctions, they do not violate the double jeopardy clause or the prohibition against cruel and unusual punishment.  Manocchio v. Kusserow, 961 F.2d 1539 (11th Cir. 1992); Greene v. Sullivan, 731 F. Supp. 838 (E.D. Tenn. 1990); Cash, DAB No. 1725; Douglas Schram, R.Ph., DAB No. 1372 (1992); and Janet Wallace, L.P.N., DAB No. 1326 (1992).⁴  Arguments that the exclusion provisions are anything but remedial have been found to be without merit.  Manocchio, 961 F.2d at 1541-42; Greene, 731 F. Supp. at 839-40.  Many federal courts have also rejected claims that the Secretary’s exclusion procedures amount to a deprivation of due process, finding no constitutionally protected property or liberty interests.  Rodabaugh v. Sullivan, 943 F.2d 855 (8th Cir. 1991); Lavapies v. Bowen, 883 F.2d 465 (6th Cir. 1989); Hillman Rehab. Ctr. v. U.S. Dep’t. of Health & Human Servs., No. 98-3789 (GEB), slip op. at 16, 1999 WL 34813783, at 16 (D.N.J. May 13, 1999); Travers v. Sullivan, 801 F. Supp. 394, 404 05 (E.D. Wash. 1992), aff’d, Travers v. Shalala, 20 F.3d 993 (9th Cir. 1994).

Page 11

Accordingly, I conclude that Petitioner’s argument that his 27-year exclusion should be shortened because it is punitive rather than remedial is without merit. 

Petitioner’s arguments, particularly those related to his age and that exclusion for 27 years is effectively a permanent exclusion, the fact his offenses occurred more than ten years ago, and that his medical license has been reinstated (P. Br. at 6-7; P. Exs. 1-3) may be construed as pleas for equitable relief.  However, I have no authority to grant such relief.  Matthew J. Girardy, DMD, DAB No. 2987 at 7 (2020).  Congress required Petitioner’s exclusion pursuant to section 1128(a)(1) and (3) of the Act and those requirements are binding upon the Secretary and me.  I am bound to follow the Act and the Secretary’s regulations.  42 C.F.R. § 1005.4(c)(1). 

Based on my de novo review, I conclude that a basis for exclusion exists and that the undisputed evidence establishes three aggravating factors and no mitigating factors.  The IG did not consider aggravating factors that have been shown not to exist.  The IG did not fail to consider mitigating factors that have been shown to exist.  I conclude that a period of exclusion of 27 years is reasonable, and no basis exists for me to reassess the period of exclusion. 

Petitioner’s exclusion is effective 20 days from the date of the IG’s notice of exclusion to Petitioner.  42 C.F.R. § 1001.2002(b). 

   III. Conclusion

For the foregoing reasons, Petitioner is excluded from participation in Medicare, Medicaid, and all other federal health care programs for 27 years, effective July 20, 2022. 

---

Endnotes

¹  Pursuant to 42 C.F.R. § 1001.3001(a), Petitioner may apply for reinstatement only after the period of exclusion expires.  Reinstatement is not automatic upon completion of the period of exclusion.

²  The pronouns he, him, and his are used as Petitioner expressed no preference. 

³  If I could substitute my discretion for that of the IG, I would be inclined to impose a permanent exclusion based on Petitioner’s egregious criminal conduct as reflected by the aggravating factors.  

⁴  The exclusion remedy serves twin congressional purposes:  the protection of federal funds and program beneficiaries from untrustworthy individuals and the deterrence of health care fraud.  S. Rep. No. 100-109, at 1-2 (1987), reprinted in 1987 U.S.C.C.A.N. 682, 686 (“clear and strong deterrent”); Cash, DAB No. 1725 at 18 (discussing trustworthiness and deterrence).  When Congress added section 1128(a)(3) in 1996, it again focused upon the desired deterrent effect: “greater deterrence was needed to protect the Medicare program from providers who have been convicted of health care, fraud felonies . . . .” H.R. Rep. 104-496(I), at 86 (1996), reprinted in 1996 U.S.C.C.A.N. 1865, 1886.