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Carlos Norberto Hornedo, III, DAB CR6804 (2025)


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division

Carlos Norberto Hornedo, III
(OIG File No. 6-17-40342-9)
Petitioner,

v.

The Inspector General,
U.S. Department of Health and Human Services,
Respondent.

Docket No. C-25-774
Decision No. CR6804
December 22, 2025

DECISION

Petitioner, Carlos Norberto Hornedo, III, is excluded from participation in Medicare, Medicaid, and all federal health care programs pursuant to section 1128(a)(1) of the Social Security Act (Act) (42 U.S.C. § 1320a-7(a)(1)), effective May 20, 2025.  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 15 years for a total minimum exclusion of 20 years1 is not unreasonable based on the existence of four aggravating factors and no mitigating factor.

Page 2

I.  Background

The Inspector General (IG) notified Petitioner by letter dated April 30, 2025, that he was excluded from participating in Medicare, Medicaid, and all federal health care programs for a minimum of 20 years.  The IG cited section 1128(a)(1) of the Act as the authority for Petitioner's exclusion based on his felony conviction in the United States District Court, Northern District of Texas (district court) of a criminal offense related to the delivery of an item or service under Medicare or a state health care program.  The IG extended the five-year minimum period of exclusion to 20 years citing the existence of four aggravating factors and no mitigating factor.  IG Exhibit (Ex.) 1 at 1.

Petitioner requested a hearing pursuant to 42 C.F.R. § 1005.2 on July 2, 2025.  I convened a prehearing conference by telephone on July 30, 2025, the substance of which is memorialized in my Prehearing Conference Order and Schedule for Filing Briefs and Documentary Evidence dated July 31, 2025 (Prehearing Order).

On September 12, 2025, the IG filed a motion for summary judgment (IG Br.) with IG Exs. 1 through 8.  On October 29, 2025, Petitioner filed a response in opposition to the IG motion for summary judgment with Petitioner's Exhibits (P. Exs.) 1 through 7.  On November 3, 2025, Petitioner filed a motion for leave to file an amended response in opposition to the IG motion for summary judgment (P. Br.), which is granted.  Petitioner also filed P. Ex. 8.  The IG filed a reply (IG Reply) on November 14, 2025.  On December 1, 2025, Petitioner filed a sur-reply (P. Reply).2

Petitioner did not object to my consideration of IG Exs. 1 through 8, and they are admitted as evidence.  The IG did not object to my consideration of P. Exs. 1 through 8, and they are admitted as evidence.

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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 a criminal offense related to the delivery of an item or service under Medicare or a state health care program.  A state health care program includes a state Medicaid program.  Act § 1128(h) (42 U.S.C. § 1320a-7(h)).  The plain language of section 1128(a)(1) shows that Congress required that the Secretary exclude an individual or entity convicted of any criminal offense related to the delivery of an item or service under Medicare or a state health care program.

Congress granted the Secretary discretion, referred to as permissive authority to exclude, even if there was no criminal conviction, in certain instances.  Pursuant to section 1128(b)(7):

(b) Permissive Exclusion.—The Secretary may exclude the following individuals and entities from participation in any Federal health care program (as defined in section 1128B(f)):

* * * *

(7) Fraud, kickbacks, and other prohibited activities.—Any individual or entity that the Secretary determines has committed an act which is described in section 1128A, 1128B, or 1129.

Act § 1128(b)(7) (42 U.S.C. § 1320a-7(b)(7)) (emphasis added).

Section 1128B(b)(1) and (2) of the Act, criminalizes soliciting or receiving kickbacks and making kickbacks, respectively.

(b)(1) Whoever knowingly and willfully solicits or receives any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind—

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(A) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program, or

(B) in return for purchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under Federal health care program,

shall be guilty of a felony and upon conviction thereof, shall be fined not more than $100,000 or imprisoned for not more than 10 years, or both.

(2) Whoever knowingly and willfully offers or pays any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind to any person to induce such person—

(A) to refer an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program, or

(B) to purchase, lease, order, or arrange for or recommend purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program,

shall be guilty of a felony and upon conviction thereof, shall be fined not more than $100,000 or imprisoned for not more than 10 years, or both.

Act § 1128B(b)(1)-(2) (42 U.S.C. § 130a-7b(b)(1)-(2)) (footnotes omitted).

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 him or her 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

Page 5

program where judgment of conviction is withheld.  The Secretary has promulgated regulations implementing these provisions of the Act.  42 C.F.R. § 1001.101(a), (c).

Exclusion for a minimum period of five years is mandatory for any individual or entity convicted of a criminal offense for which exclusion is required by section 1128(a) of the Act.  Act § 1128(c)(3)(B) (42 U.S.C. § 1320a-7(c)(3)(B)).  Pursuant to 42 C.F.R. § 1001.102(b), an individual's period of exclusion may be extended based on the presence of specified aggravating factors.  Only if the aggravating factors justify an exclusion of longer than five years, however, are mitigating factors considered as a basis for reducing the period of exclusion to no fewer than five years.  42 C.F.R. § 1001.102(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 Petitioner from participation in Medicare, Medicaid, and all federal health care programs; and

Whether the length of the proposed period of 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 followed by the pertinent findings of undisputed fact and analysis.

1.  Petitioner's request for hearing was timely, 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.

Page 6

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).

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).

The IG moved for summary judgment.  Petitioner opposes summary judgment.  Petitioner's arguments will be discussed in greater detail in subsequent sections of this decision.  But, for purpose of discussing whether summary judgment is appropriate or not, I view Petitioner's arguments under two broad issues: (1) whether, if exclusion is appropriate, the Secretary or the IG should have exercised permissive authority to exclude Petitioner under section 1128(b)(7) of the Act rather than section 1128(a)(1) of the Act; and (2) whether Petitioner's period of exclusion should be reassessed and the period be reduced because the IG improperly considered aggravating and mitigating factors.  There are no genuine disputes of material fact related to the first issue; that issue must be resolved against Petitioner as a matter of law; and summary judgment is appropriate as to that issue.  The second issue must also be resolved against Petitioner, for even if I do not weigh the evidence and draw all reasonable inferences in Petitioner's favor, I cannot infer based on the evidence presented by Petitioner that there was a

Page 7

mitigating factor the IG failed to consider.  As a result, I have no discretion to reassess the period of exclusion.  There are no genuine disputes of material facts in this case.  All issues must be resolved as matters of law.  Accordingly, I conclude that summary judgment for the IG is appropriate.

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

4.  The Secretary and the IG have no discretion to exclude Petitioner pursuant to section 1128(b)(7) of the Act, because Congress requires exclusion under section 1128(a)(1) of the Act if exclusion is based on a conviction and the other elements of the section are satisfied.

a.  Undisputed Facts

The parties were advised by my Prehearing Order ¶ 8 that on summary judgment a fact alleged and not specifically denied may be accepted as true and all evidence will be considered admissible and true absent specific objection to admissibility or accuracy.  The following material facts are undisputed.  All factual inferences are drawn in Petitioner's favor on summary judgment.

On December 1, 2023, an Information was filed in the district court charging Petitioner with one count of conspiracy to pay and receive health care kickbacks in violation of 18 U.S.C. § 371.  IG Ex. 2 at 1.  The charge alleged:

Beginning in or around 2015 and continuing through in or around 2019 in the Fort Worth Division of the Northern District of Texas and elsewhere, the defendant Carlos Hornedo did knowingly and willfully conspire and agree with other persons both known and unknown to the United States Attorney, to commit and abet certain offenses against the United States, including: to violate the Anti-Kickback statute by knowingly and willfully soliciting or receiving any remuneration, including any kickback, directly or indirectly, overtly or covertly, in cash or in kind, in return for referring any individual for the furnishing or arranging for the furnishing of any item or service or in return for ordering or recommending the ordering of any item or service for which payment may be made in whole or in part under a Federal health care program, in violation of 42 U.S.C. §§ 1320a-7b(b)(1)(A) and 1320a-7b(b)(1)(B).

Page 8

IG Ex. 2 at 1.  In short, Petitioner's alleged crime was engaging in a conspiracy to commit the crime of violating the anti-kick provisions of section 1128B(b)(1)(A) and (B) of the Act (42 U.S.C. § 1320a-7b(b)(1)(A) and (B)).  Knowingly and willfully soliciting or receiving or offering a kickback, bribe, or rebate is a felony criminal offense under section 1128B(b)(1)(A) and (B) of the Act.

On January 5, 2024, Petitioner signed a guilty plea agreement.  Petitioner agreed to plead guilty to the only count of the information and admitted facts related to his offense in a factual resume executed on or about the same time.  IG Ex. 3 at 1-2.  The government agreed not to pursue any other changes against Petitioner based on the conduct underlying the information and guilty plea.  The government agreed that under specified circumstances, it would move for a one-level reduction in sentence because Petitioner timely notified the government of his intent to plead guilty, avoiding the need for the government to expend resources preparing for trial.  Petitioner acknowledged that, due to his guilty plea, he would be excluded from Medicare and all federal health care programs.  He agreed to complete and execute all documents necessary to effectuate his exclusion within 60 days of receiving documents.  IG Ex. 3 at 5-6.  Petitioner did not waive the right to request administrative review of his exclusion or the duration of the exclusion.

On January 5, 2024, Petitioner admitted the following facts, among others, as part of the factual resume he executed as part of his plea agreement:

Petitioner was a doctor in Lardo, Texas.

Petitioner ordered toxicology tests for patients he saw from two laboratories, ULS and SDL.

Petitioner became aware of ULS and SDL through a marketer (JR) he knew who was subsequently charged as a codefendant.

Petitioner and JR agreed Petitioner would submit a substantial number of toxicology orders to ULS and SDL in exchange for illegal kickbacks.

Petitioner issued orders that resulted in billings by ULS and SDL to federal healthcare programs that exceeded $4.1 million.

Petitioner received approximately $412,000 in kickbacks paid in various ways.

IG Ex. 4 at 2-3.

Page 9

On January 10, 2024, Petitioner pleaded guilty to the one count of conspiracy to pay and receive kickbacks as alleged in the information.  On January 25, 2024, Petitioner was adjudged guilty by the district court based on his guilty plea.  On May 14, 2024, Petitioner was sentenced to 12 months and one day in prison, followed by two years of supervised release, and to pay a fine of $50,000.  Petitioner was also ordered to pay restitution of $412,000 for disbursement to the Centers for Medicare & Medicaid Services (CMS), which administers Medicare for the Secretary.  IG Exs. 5, 6, 7; P. Ex. 1 at 17 (document page counter) ¶ 70; P. Ex. 5.

On November 4, 2024, the Texas Medical Board revoked Petitioner's physician's license based on his conviction of conspiracy to solicit or receive kickbacks.  IG Ex. 8.

b.  Analysis

The IG cites section 1128(a)(1) of the Act as the basis for Petitioner's mandatory exclusion.  The statute provides in relevant part:

(a)  MANDATORY EXCLUSION. – The Secretary shall exclude the following individuals and entities from participation in any Federal health care program (as defined in section 1128B(f)):

(1)  CONVICTION OF PROGRAM-RELATED CRIMES. – Any individual or entity that has been convicted of a criminal offense related to the delivery of an item or service under title XVIII or under any State health care program.

Act § 1128(a)(1).

Congress has, by the plain language of section 1128(a)(1) of the Act, required the Secretary to exclude from participation in Medicare, Medicaid, and all federal health care programs any individual or entity:  (1) convicted of a criminal offense, whether a misdemeanor or felony; (2) where the offense is related to the delivery of an item or service; and (3) the delivery of the item or service was under Medicare or a state health care program.  The elements that trigger an exclusion under section 1128(a)(1) of the Act are triggered in this case.

Petitioner concedes he was convicted of conspiracy to violate the antikick back statute.  P. Br. at 8.  His concession is supported by the undisputed facts.  Specifically, he entered a plea of guilty in the district court, the guilty plea was accepted, and judgment was entered by the district court that he was guilty of conspiracy to violate the antikick back

Page 10

statute.  IG Exs. 3, 5, 6, 7; P. Ex. 5.  Accordingly, I conclude that Petitioner was convicted within the meaning of 1128(i) of the Act.  Act § 1128(i)(1) (judgment of conviction was entered), (2) (finding of guilt by a court); and (3) (Petitioner's guilty plea accepted by a court).

The second and third elements for mandatory exclusion under section 1128(a)(1) of the Act require me to consider the circumstances underlying the offense and determine whether the offense of which Petitioner was convicted was committed in connection with the delivery of a health care item or service and whether the delivery of the health care item or service was under Medicare or a state health care program.

The Departmental Appeals Board (Board) has long held that the statutory terms describing an offense do not control whether that offense is "related to" the delivery of a health care item or service under Medicare or a state health care program for purposes of exclusion pursuant to section 1128(a) of the Act.  E.g., Dewayne Franzen, DAB No. 1165 (1990) (inquiry is whether conviction is related to Medicaid fraud, not whether the petitioner was convicted of Medicaid fraud).  Rather, an ALJ must examine whether there is a "common sense connection or nexus between the offense and the delivery of an item or service under the program."  Scott D. Augustine, DAB No. 2043 at 5-6 (2006) (citations omitted); Dr. Timothy Baxter, DAB No. 3074 at 15 (2022); Summit S. Shah, MD, DAB No. 2836 at 6 (2017).  The terms "related to" and "relating to" in 42 U.S.C. § 1320a-7 simply mean that there must be a nexus or common-sense connection.  Friedman v. Sebelius, 686 F.3d 813, 820 (D.C. Cir. 2012) (describing the phrase "relating to" 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 quotes omitted); Quayum v. U.S. Dep't of Health & Human Servs., 34 F.Supp.2d 141, 143 (E.D.N.Y. 1998).

To determine whether there is a nexus or common-sense connection, "evidence as to the nature of an offense may be considered," such as the "facts upon which the conviction was predicated."  Robert C. Hartnett, DAB No. 2740 at 7 (2016) (quoting Berton Siegel, D.O., DAB No. 1467 at 6-7 (1994)).  The bar to a petitioner collaterally attacking the conviction underlying an exclusion does not preclude review of the facts and circumstances on which the conviction was based.  An ALJ may consider extrinsic evidence to determine the events which formed the basis for the offense.  Narendra M. Patel, M.D., DAB No. 1736 (2000).

The undisputed facts establish the required connection, rational link, or nexus between Petitioner's criminal offense and the delivery of a health care item or service under Medicare or a state health care program.  My decision is guided by the Board decision in W. Scott Harkonen, M.D., DAB No. 2485 (2012), aff'd, Harkonen v. Sebelius No. C13-0071 PJH, 2013 WL 5734918 (N.D. Cal. Oct. 22, 2013).

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In Harkonen, an appellate panel of the Board discussed in detail the elements of section 1128(a)(3) of the Act, which also requires that the offense of which one is convicted have been committed in connection with the delivery of a health care item or service.  The Board discussed that in prior cases, it had interpreted the language "in connection with" to require a common-sense connection or nexus, also characterized as a "rational link," between the criminal offense and the delivery of a health care item or service.  Harkonen, DAB No. 2485 at 7.  The Board noted that in Erik D. DeSimone, R.Ph., DAB No. 1932 (2004), it found the required nexus in a case where a pharmacist, in the guise of performing his professional duties, took controlled substances for his own use.  Harkonen, DAB No. 2485 at 7.  In Kenneth M. Behr, DAB No. 1997 (2005), the Board found the nexus where a pharmacist who had access to drugs due to his position attempted to embezzle those drugs, rejecting the argument that the underlying criminal offense must involve actual delivery of a health care item or service.  Harkonen, DAB No. 2485 at 7-8.  In Ellen L. Morand, DAB No. 2436 (2012), the Board concluded that the Petitioner's theft from the evening deposit of the pharmacy that employed her had the requisite nexus considering that the evening deposit included revenue from the sale of health care items and that the Petitioner diverted those funds to her use.  Harkonen, DAB No. 2485 at 8.  The Board summarized its prior holdings to be that "frauds or thefts that are linked in a rational way to the delivery of a health care item or service do fall within the ambit" of section 1128(a)(3).  Harkonen, DAB No. 2485 at 8.  The Board further noted that its interpretation is consistent with the interpretation of similar language found in section 1128(a)(1) of the Act (42 U.S.C. § 1320a-7(a)(1)).  Harkonen, DAB No. 2485 at 9.  The Board pointed out that its interpretations of the language of section 1128(a) "effectuates the twin purposes of section 1128(a): (1) to protect federal health care programs and their beneficiaries from individuals who have been shown to be untrustworthy; and (2) to deter health care fraud."  Harkonen, DAB No. 2485 at 9 (citations omitted).  In Harkonen, the Board stated that section 1128(a)(3) does not require proof of an actual impact or effect upon the delivery of a health care item or service, rather the ALJ must consider all the evidence of circumstances underlying the criminal offense, including evidence extrinsic to the criminal proceedings if reliable and credible, to find the rational link between the criminal offense and the delivery of a health care item or service.  Harkonen, DAB No. 2485 at 10.

The rational link or nexus between Petitioner's conviction of conspiracy to receive kickbacks and the delivery of a health care item or service is more obvious in this case than the nexus found in Harkonen and the cases discussed in that decision by the Board.  Kickbacks are prohibited by section 1128B(b)(1) and (2) of the Act, which provide for criminal penalties for soliciting or receiving kickbacks in connection with federal health care programs.  In Petitioner's case kickbacks were offered and paid for Petitioner ordering toxicology testing by ULS and SDL.  IG Ex. 4 at 2.  There is no dispute by Petitioner that toxicology tests are healthcare services.  Petitioner admitted as part of his

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plea agreement that he issued orders that resulted in billings by ULS and SDL to federal healthcare programs that exceeded $4.1 million and that he received approximately $412,000 in kickbacks.  IG Ex. 4 at 2-3.  The fact the district court ordered that restitution of $412,00 be paid to CMS, which administers Medicare, is further evidence of the nexus.  IG Ex. 6 at 3.

I conclude that the second and third elements necessary to trigger mandatory exclusion under section 1128(a)(1) of the Act are satisfied, i.e., Petitioner's offense was related to the delivery of a health care item or service, specifically the toxicology tests, and the toxicology tests were billed to Medicare.

Petitioner argues that mandatory exclusion under section 1128(a)(1) of the Act does not apply in his case because the IG has permissive authority to exclude for kickbacks under section 1128(b)(7) of the Act with a shorter period of exclusion.  Petitioner's theory is that section 1128(b)(7) applies because it specifically mentions kickbacks and section 1128(a)(1) of the Act does not.  Petitioner urges me to conclude that interpretation of the provisions of sections 1128(a)(1) and 1128(b)(7) of the Act is necessary to apply those provisions of the Act.  P. Br. at 8-10; P. Reply at 2.

I conclude that the language of sections 1128(a)(1) and 1128(b)(7) is clear and no interpretation is necessary.  Section 1128(a)(1) of the Act provides:

(a)  MANDATORY EXCLUSION. – The Secretary shall exclude the following individuals and entities from participation in any Federal health care program (as defined in section 1128B(f)):

(1)  CONVICTION OF PROGRAM-RELATED CRIMES. – Any individual or entity that has been convicted of a criminal offense related to the delivery of an item or service under title XVIII or under any State health care program.

Act § 1128(a)(1) (emphasis added).

Section 1128(b)(7) of the Act provides:

(b) Permissive Exclusion.—The Secretary may exclude the following individuals and entities from participation in any Federal health care program (as defined in section 1128B(f)):

* * * *

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(7) FRAUD, KICKBACKS, AND OTHER PROHBITED ACTIVITIES.—Any individual or entity that the Secretary determines has committed an act which is described in section 1128A, 1128B, or 1129.

Act § 1128(b)(7)(emphasis added).  Reviewing the plain language of the two sections it is readily apparent that:

Section 1128(a)(1) applies only if there is a conviction; and

Section 1128(b)(7) does not require a conviction but grants the Secretary authority to determine whether fraud, a kickback, or another prohibited act has occurred.

It is also readily apparent from the plain language of the subsections that:

In section 1128(a)(1) Congress mandates that the Secretary exclude when there is a conviction of an offense related to the delivery of an item or service under Medicare or a state healthcare program; and

In section 1128(b)(7) Congress permits the Secretary to decide whether to exclude if the Secretary determines that fraud, a kickback, or other prohibited activity occurred.

In this case, I have concluded that Petitioner was convicted and that there is the required nexus or logical connection between the conduct for which he was convicted and the delivery of an item or service under Medicare or a state health care program.  Therefore, Petitioner's exclusion is mandatory under section 1128(a)(1).  The Secretary has no discretion not to exclude3 and I am bound by the law to uphold the exclusion.  I also conclude that there is no ambiguity or lack of clarity that requires statutory interpretation and Petitioner's legal argument must be resolved against him as a matter of law.

The Board has noted, the federal "courts have repeatedly held that the I.G. is . . . required to impose a mandatory exclusion even if an individual's conduct also falls within the scope of a permissive exclusion provision."  Gregory J. Salko, M.D., DAB No. 2437 at 4

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(2012), citing Timothy Wayne Hensley, DAB No. 2044 at 15 (2006) (and cases cited therein); Craig Richard Wilder, DAB No. 2416 at 7 (2011); Lorna Fay Gardner, DAB No. 1733 (2000).

In Anderson v. Thompson, 311 F.Supp.2d 1121, 1124-25 (D. Kan. 2004), the judge looked to the plain language of sections 1128(a)(1) and (b)(7) of the Act and rejected an argument very similar to Petitioner's before me, i.e., that the rules of statutory construction require the application of section 1128(b)(7) which specifically lists kickbacks, rather than the general category of convicted persons.  The judge in Anderson concluded that the intent of Congress was clear and unambiguous, and no statutory interpretation was necessary.  Id. 1125.  Nevertheless, the judge went on to examine the legislative history, though unnecessary, and found the history consistent with the plain language, specifically that section 1128(a)(1) required mandatory exclusion based on a conviction while section 1128(b)(7) authorized permissive exclusion based on an administrative determination of the Secretary that there was fraud, a kickback, or other prohibited conduct.  Id. at 1125-26.

In Baxter v. Becerra, 2024 WL 627262 at 7-12 (E.D. Va. 2024), the court concluded that the major questions doctrine was not involved where there was no vast economic or political significance to the Secretary's interpretation of section 1128(a)(1) of the Act, and the nongovernmental party was accorded the process due under the Act and regulations.  The judge in Baxter also concluded that there are two steps involved in the exclusion process.  First, the Secretary determines whether a mandatory exclusion is required by Congress under section 1128(a) of the Act, if so, permissive exclusion is moot.  Second, if mandatory exclusion is not required, the Secretary may then consider permissive exclusion under section 1128(b) of the Act.  Id. at 14-16.  Other federal courts have concluded that when mandatory exclusion is required by section 1128(a), permissive exclusion is not possible under section 1128(b) of the Act.  See e.g., Figueroa v. Secretary HHS, 2025 WL 2337297 (M.D. Fl. 2025); Parrino v. Price, 869 F.3d 392 (6th Cir. 2017); 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).

Petitioner's argument that he should be subject to exclusion under section 1128(b) of the Act rather than section 1128(a), is without merit and must be resolved against him as a matter of law.

Accordingly, I conclude that the elements necessary to trigger an exclusion pursuant to § 1128(a)(1) of the Act are satisfied by the undisputed facts, and Petitioner's exclusion is required by section 1128(a)(1) of the Act.

5.  Section 1128(c)(3)(B) of the Act requires a minimum exclusion of five years for any exclusion pursuant to section 1128(a) of the Act.

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I have concluded that a basis exists to exclude Petitioner pursuant to section 1128(a)(1) of the Act.  Therefore, the IG must exclude Petitioner for a minimum period of five years pursuant to section 1128(c)(3)(B) of the Act.  There is no discretion to impose a lesser period.  The remaining issue is whether it is unreasonable to extend Petitioner's exclusion by an additional 15 years for a total exclusion period of 20 years.

6.  Four aggravating factors established by 42 C.F.R. § 1001.102(b) exist in this case that were considered by the IG as a basis to extend the period of exclusion beyond five years.

7.  Drawing all reasonable favorable inferences for Petitioner without weighing the evidence, Petitioner has not shown there is a genuine dispute that a mitigating factor established by 42 C.F.R. § 1001.102(c) exists that the IG failed to consider in determining the period of exclusion.

The IG cited four aggravating factors and no mitigating factor in extending Petitioner's period of exclusion from the mandatory minimum five-year exclusion to 20 years.  The aggravating factors cited by the IG are:

a.  The acts for which Petitioner was convicted caused or were intended to cause financial loss of $50,000 or more;

b.  The acts for which Petitioner was convicted occurred over a period of one year or more;

c.  The sentence imposed on Petitioner included incarceration; and

d.  Petitioner was subject to an adverse action by a federal, state, or local government based on the same set of circumstances that were the basis for his exclusion, in this case, the conviction.

IG Ex. 1 at 1.  Petitioner argues that exclusion for 20 years is unreasonable.  Petitioner does not challenge the aggravating factors cited by the IG.  Rather, Petitioner argues that the IG failed to consider a mitigating factor recognized by 42 C.F.R. § 1001.102(c)(2).  P. Br. at 10-15; P. Reply at 3-4.

a.  Petitioner's offense resulted in a loss to one or more entities of $50,000 or more.  42 C.F.R. § 1001.102(b)(1).

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The IG may consider as an aggravating factor that the acts of which one was convicted caused, or were intended to cause, a financial loss of $50,000 or more to a government agency or program, or to one or more other entities.  42 C.F.R. § 1001.102(b)(1).

Petitioner admitted under his plea agreement that he ordered toxicology tests that resulted in billing by ULS and SDL to federal health care programs of more than $4.1 million and in exchange he received kickbacks of $412,000.  IG Ex. 4 at 2 ¶ 5.  Petitioner does not dispute that the district court ordered that he pay restitution of $412,000 to CMS.  IG Ex. 6 at 2-3.  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).

I conclude that it is not disputed that the aggravating factor established by 42 C.F.R. § 1001.102(b)(1) exists in this case.

b.  The acts that resulted in Petitioner's conviction were committed over a period of one year or more.  42 C.F.R. § 1001.102(b)(2). 

Acts that resulted in the conviction or similar acts that occur over a year or more may be considered by the IG to extend a period of exclusion beyond the five-year minimum.  42 C.F.R. § 1001.102(b)(2).

The criminal information charged Petitioner with conspiring to solicit or receive kickbacks from 2015 through 2019, a period of more than one year.  IG Ex. 2 at 1.  Petitioner admitted that his criminal conduct occurred from around 2015 through 2019 by pleading guilty to that charge.  Petitioner stipulated as part of his plea agreement that between 2016 and 2018, he received kickbacks through a laboratory in which he owned shares.  IG Ex. 4 at 3 ¶ 8.  Petitioner does not deny that the course of conduct underlying his conviction lasted for more than a year.  Accordingly, I conclude that the aggravating factor established by 42 C.F.R. § 1001.102(b)(2) exists in this case.

c.  Petitioner was sentenced to be incarcerated.  42 C.F.R. § 1001.102(b)(5).

An aggravating factor that may be considered under 42 C.F.R. § 1001.102(b)(5), is that the sentence imposed by the court included incarceration.

It is undisputed that on May 14, 2024, the district court sentenced Petitioner to incarceration of 12 months and one day.  IG Ex. 6 at 2.

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Accordingly, I conclude that the aggravating factor established by 42 C.F.R. § 1001.102(b)(5) exists in this case.

d.  Petitioner was subject to an adverse action by a federal, state, or local government based on the same set of circumstances that were the basis for his exclusion, in this case, the conviction.  42 C.F.R. § 1001.102(b)(9).

The IG may consider as a basis for lengthening a period of exclusion that an individual subject to exclusion was subject of an adverse action by a federal, state, or local agency or board based on the same set of circumstance that are the basis for the exclusion.  42 C.F.R. § 1001.102(b)(9).

There is no dispute that on November 4, 2024, the Texas Medical Board revoked Petitioner's physician's license based on his conviction of conspiracy to solicit or receive kickbacks.  IG Ex. 8.

Accordingly, I conclude that the aggravating factor established by 42 C.F.R. § 1001.102(b)(9) exists in this case.

e.  Petitioner has not shown a genuine dispute of fact exists regarding the existence of a mitigating factor under 42 C.F.R. § 1001.102(c) that the IG failed to consider.

If any of the aggravating factors authorized by 42 C.F.R. § 1001.102(b) are cited by the IG to justify an exclusion of longer than five years, as in this case, then mitigating factors may be considered as a basis for reducing the period of exclusion to no fewer than five years.  42 C.F.R. § 1001.102(c).  The IG did not list in the notice of exclusion, and therefore did not consider, any mitigating factors in deciding to extend Petitioner's exclusion to 20 years.  IG Ex. 1.

The only authorized mitigating factors that the IG or I may consider are listed in 42 C.F.R. § 1001.102(c):

(1)  In the case of an exclusion under § 1001.101(a), whether the individual or entity was convicted of three or fewer misdemeanor offenses and the entire amount of financial loss (both actual loss and intended loss) to Medicare or any other Federal, State, or local governmental health care program due to the acts that resulted in the conviction, and similar acts, is less than $5,000;

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(2)  The record in the criminal proceedings, including sentencing documents, demonstrates that the court determined that the individual had a mental, emotional or physical condition before or during the commission of the offense that reduced the individual's culpability; or

(3)  The individual's or entity's cooperation with Federal or State officials resulted in –

(i)  Others being convicted or excluded from Medicare, Medicaid and all other Federal health care programs,

(ii)  Additional cases being investigated or reports being issued by the appropriate law enforcement agency identifying program vulnerabilities or weaknesses, or

(iii)  The imposition against anyone of a civil money penalty or assessment under part 1003 of this chapter.

Petitioner has the burden to prove by a preponderance of the evidence that there is a mitigating factor for me to consider.  42 C.F.R. § 1005.15(b), (c); Prehearing Order ¶ 4; Stacey R. Gale, DAB No. 1941 at 9 (2004); Arthur C. Haspel, D.P.M., DAB No. 1929 at 5 (2004).  On summary judgment, Petitioner must show at least a genuine dispute of material fact regarding the existence of a mitigating factor and mere allegations are insufficient.

I conclude that the evidence viewed in a light most favorable to Petitioner, does not show genuine disputes of material fact that would make it more likely than not that the district court judge found that Petitioner had a mental condition that reduced his culpability.  42 C.F.R. §§ 1001.102(c)(2).

Petitioner argues that:

The record in the criminal proceeding demonstrates that at the time [Petitioner] entered into the criminal conspiracy to receive kickbacks, he was suffering from severe emotional and mental distress.

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P. Br. at 11.  Petitioner argues in his reply brief that the evidence shows he was "suffering from emotional and mental distress at the time he received kickbacks."  P. Reply at 3.

For purposes of summary judgment, I accept as true Petitioner's assertions that he was suffering severe emotional and mental distress when he agreed to the conspiracy to receive kickbacks and when he was receiving kickbacks.  The specific cause of Petitioner's emotional and mental distress is not relevant to my analysis.

The fact that Petitioner was under emotional and mental distress when he entered the conspiracy and when he received kickbacks does not show that the district court determined that Petitioner was less culpable for his criminal conduct due to his mental or emotional condition before or during commission of the offense of which Petitioner was convicted.  Petitioner attempts to show that there is a genuine dispute of material fact that it is more likely than not the district court found Petitioner had reduced culpability by pointing to various pieces of evidence.  But even though I accept the evidence as true for purposes of summary judgment, I cannot reasonably infer that the judge found that Petitioner had reduced culpability for his crime.

Petitioner placed in evidence the presentence investigation report (PSR) prepared in Petitioner's case.  P. Ex. 1.  Petitioner provided the probation officer who interviewed him a written statement.  Petitioner stated he was influenced to commit the offense because he was emotionally vulnerable because someone close to him was experiencing a challenging period.  Petitioner stated that his emotional vulnerability caused him to be more trusting than he should have been and he lacked the "diligence to resist working with the laboratory" involved in the kickback scheme.  P. Ex. 1 at 17 (document page counter).  In her offense level computation, the probation officer reduced the offense level because Petitioner accepted responsibility for his offense and he cooperated with the government by timely notifying them he intended to plead guilty.  P. Ex. 1 at 22 (document page counter).   The probation officer summarized Petitioner's mental and emotional health as involving a history of a mental health condition that was stable under treatment.  P. Ex. 1 at 25 (document page counter) ¶ 106.  The probation officer made no findings that a mental or emotional health problem affected Petitioner's culpability for his offense.  The probation officer listed the maximum period of imprisonment as five years for Petitioner felony offense, and based on her calculations, she determined the sentencing guidelines imprisonment range was 24 to 30 months.  P. Ex. 1 at 31 (document page counter) ¶ 118-119.  The probation officer specifically stated that she identified no factors that would warrant departure from the sentencing guideline range.  P. Ex. 1 at 33 (document page counter) ¶ 130.  Petitioner also placed in evidence an addendum to the presentence report in Petitioner's case, which does not refer to any mental or emotional issues.  P. Ex. 6.

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P. Ex. 7 is a June 13, 2025 letter from the district court judge who sentenced Petitioner.  He explains in his letter that he sentenced Petitioner to 12 months and one day of incarceration so Petitioner could receive good-time sentence credits so that he was only in prison for 10 and a half months.  The judge also notes he imposed a $50,000 fine and ordered restitution of $412,000.  The judge opined that Petitioner had fulfilled his sentence and should be allowed to resume his medical career.  The judge noted Petitioner's crime was financial and, aside from the fact the testing Petitioner ordered as part of the kickback scheme was unnecessary, he was unaware of any other harm suffered by Petitioner's patients.  He stated he received 50 letters prior to sentencing urgently requesting leniency based on Petitioner's service to the community so that he could return to practice and his patients as soon as possible.  The judge indicates that the letters persuaded him to impose imprisonment of 12 months and one day rather than 24 to 30 months.  P. Ex. 7.  The judge does not state that he considered Petitioner to be of reduced culpability when he decided on the appropriate sentence.

Petitioner placed in evidence the sentencing memorandum and motion for downward variance in sentence filed in Petitioner's case.  P. Ex. 8.  In his motion, Petitioner requested that the district court impose 12 months of home confinement followed by 12 months of supervised release and 500 hours of community service rather than the range of imprisonment calculated by the probation officer in her presentence report.  P. Ex. 8 at 3 (document page counter).  Petitioner cited four grounds for the downward departure from the sentencing guideline range of imprisonment calculated by the probation officer.

1.  Petitioner's professional and personal history and limited involvement in the kickback conspiracy show there is little danger of recurrence.

2.  Petitioner had no prior criminal record, he was committed to his community, he had a history of providing quality care consistently to an underserved population, he was not danger to the community but an asset to the public, and prolonged incarceration would be inconsistent with the goals of sentencing.

3.  Petitioner's offense involved no violence or harm to patients and Petitioner made full restitution before sentencing.

4.  The goal of rehabilitation cannot be achieved if Petitioner could not continue to be a productive and necessary member of the community through his work.

P. Ex. 8 at 5-12 (document page counter).  In discussing his risk for recidivism, Petitioner shared what he told the probation officer during the presentence investigation related to his emotion vulnerability due to someone close to him going through a challenging period and his failure to resist working with the laboratory involved in the kickback scheme.  P. Ex. 8 at 6 (document page counter).  Petitioner also asserted in his motion

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that he was in a "vulnerable mental state" being worried about the situation with the person close to him, when he was approached about the conspiracy.  P. Ex. 8 at 7 (document page counter).  He stated that he "neglected the ordinary checks and diligence he was accustomed to making in business ventures, and relied on the advice and affirmations presented to him."  P. Ex. 8 at 7 (document page counter).  Petitioner stated he did not seek to excuse his conduct but wanted the district court to understand why his lapse in judgment occurred, including that he was suffering serious emotion distress.  P. Ex. 8 at 7-8 (document page counter).

The transcript of Petitioner's sentencing proceedings is in evidence as IG Ex. 7 and P. Ex. 5.4  The district court judge stated during sentencing that he accepted and adopted as his own the findings of fact from the presentence report and its addendum because there were no unaccepted objections to those findings.  IG Ex. 7 at 5.  The judge also stated he did not accept Petitioner's motion for downward variance in sentencing that would result in Petitioner serving no incarceration because he wanted to avoid sentencing disparity among similarly situated defendants.  IG Ex. 7 at 5.  The judge recognized that the probation officer calculated that guideline range for imprisonment of 24 to 30 months.  But the judge imposed a sentence to incarceration of 12 months and one day based, at least in part, on the 58 letters he had received attesting to Petitioner's good character, scant chance for reoffending, and the service he provided to his family, military, and community.  IG Ex. 7 at 6, 10, 12.  The district court judge made no statement during the sentencing proceeding about Petitioner's mental and/or emotional condition before or during the commission of the offense that reduced Petitioner's culpability for the offense.  The judge also made no statements that support a reasonable inference that he even considered Petitioner's mental and/or emotional condition in deciding upon the appropriate sentence for Petitioner.  In fact, the judge specifically stated in the sentencing transcript that the 58 letters he received attesting to Petitioner's good character, scant chance for reoffending, and the service he provided to his family, military, and community played an important role in his downward departure from the guidelines sentence calculated by the probation officer.  IG Ex. 7 at 6.  The district court judge's statements on the record at sentencing are consistent with the letter he sent to the Texas Medical Board.  P. Ex. 7.  The fact that the judge sentenced Petitioner to a period of incarceration that was below the range suggested by the federal sentencing guidelines does not permit an inference that he found reduced culpability due to Petitioner's mental condition as required by 42 C.F.R. § 1001.102(c)(2), particularly in this case because the judge stated at sentencing and again in his letter to the Texas medical board that it was the letters he received that affected the sentence and he made no mention of reduced culpability based on any mental or emotional condition.

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I conclude that the evidence does not permit a reasonable inference for Petitioner that the district court determined Petitioner had a mental and/or emotional condition before or during the commission of his offense that reduced Petitioner's culpability, and such a diminution is required to trigger the mitigating factor established by 42 C.F.R. § 1001.102(c)(2).  Accordingly, I conclude that Petitioner has not established the mitigating factor under 42 C.F.R. § 1001.102(c)(2).

Petitioner states in his brief that he offered and agreed to cooperate with government authorities.  He notes that cooperation with state or federal officials can be a mitigating factor.  42 C.F.R. § 1001.102(c)(3).  But Petitioner concedes that his offer to cooperate did not result in the conviction of others, additional cases being investigated, or a civil money penalty being imposed.   He points out he did pay the full amount ordered as restitution before sentencing.  P. Br. at 11 n. 10.  The presentence investigation report notes:

The defendant has clearly demonstrated acceptance of responsibility for his offense within the meaning of USSG §3E1.1(a); therefore, 2 levels will be subtracted. Furthermore, on January 11, 2024, Assistant U.S. Attorney P.J. Meitl filed a notice that the defendant assisted the government in the investigation or prosecution of his own misconduct by timely notifying authorities of his intention to enter a plea of guilty, thereby permitting the government to avoid preparing for trial. The timeliness of his notification to enter a plea of guilty permitted the government and the Court to allocate their resources efficiently.

P. Ex. 1 at 20 (document page counter) ¶ 75.  The evidence shows that Petitioner did cooperate by paying the restitution before sentencing and by notifying the government of his intent to plead guilty.  However, Petitioner cooperation is not the type of cooperation that triggers the mitigating factor established by 42 C.F.R. § 1001.102(c)(3) which requires:

(3)  The individual's or entity's cooperation with Federal or State officials resulted in –

(i)  Others being convicted or excluded from Medicare, Medicaid and all other Federal health care programs,

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(ii)  Additional cases being investigated or reports being issued by the appropriate law enforcement agency identifying program vulnerabilities or weaknesses, or

(iii)  The imposition against anyone of a civil money penalty or assessment under part 1003 of this chapter.

Petitioner's concession that he did not render assistance to the government that resulted in others being convicted, additional cases being investigated, or a civil money penalty being imposed is a concession that the mitigating factor under 42 C.F.R. § 1001.102(c)(3) is not triggered in this case.

I conclude that Petitioner has failed to establish any mitigating factor that may be considered under 42 C.F.R. § 1001.102(c).  Accordingly, this case presents no mitigating factors the I.G. failed to consider that may have justified reducing the period of Petitioner's exclusion.

8.  Exclusion for 20 years is not unreasonable in this case.

The Secretary requires by regulation that the ALJ determine whether the period of the exclusion imposed is "unreasonable," if a period greater than the minimum period is imposed by the IG.  42 C.F.R. § 1001.2007(a)(1)-(2).  The Board has interpreted the regulations as significantly limiting the scope of ALJ review.  The regulation states that the ALJ must determine whether the length of exclusion imposed is "unreasonable," without definition of what is unreasonable or direction for how to determine whether a period of exclusion is unreasonable.  42 C.F.R. § 1001.2007(a)(1)(ii).  The drafters of the regulation explained that the intent of the regulation is to ensure that if the IG's proposed period of exclusion is "within a reasonable range based on demonstrated criteria, the ALJ has no authority" to change the period of exclusion.  57 Fed. Reg. 3298, 3321 (Jan. 29, 1992).  The drafters provided no explanation of what are "demonstrated criteria."

The Board has determined 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 determine whether the period of exclusion imposed by the IG falls within a "reasonable range."  Edwin L. Fuentes, DAB No. 2988 at 7-10 (2020); Juan de Leon, Jr., DAB No. 2533 at 4-5; 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.  The Board cautions that whether the ALJ thinks

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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.  In John (Juan) Urquijo, DAB No. 1735 (2000), the Board concluded 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 decide the appropriate extension of the period of exclusion beyond the minimum.  In Gary Alan Katz, R.Ph., DAB No. 1842 (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.  The Board reasoned that when aggravating factors are considered by the IG as a reason to extend a period of exclusion, some part of the extended period of exclusion should be attributable to each aggravating factor considered.  Because in Katz, the ALJ found one aggravating factor considered by the IG was not proved before the ALJ, the Board concluded that the period of exclusion imposed by the IG was no longer in the reasonable range and reassessed the period of exclusion.  The Board had the opportunity to define the term "reasonable range" and describe how to weigh aggravating and mitigating factors but did not do so.  The Board engaged in weighing the remaining aggravating factors in Katz but did not explain the weighing process in any detail or cite any authority for the process it employed.  Id. at 4-8.  The Board, relying upon a prior Board decision and the preamble to the regulations, stated in a footnote that:

[A] "reasonable range" refers to a range of exclusion periods that is more limited than the full range authorized by the statute [five years to permanent exclusion under section 1128(a) of the Act] and that is tied to the circumstances of the individual case.  If the ALJ determines that the length of the exclusion imposed by the I.G. is within this range under the circumstance as found by the ALJ, he may not change it even if he believes that another exclusion period is more reasonable.

Id. at 5 n.4.  The Board's decision in Katz reflects its determination that it is the aggravating and mitigating factors that the Board and an ALJ consider in determining whether a period of exclusion is unreasonable.  The Board's decision also indicates that the facts and circumstances related to the aggravating factors are what are weighed when determining how each aggravating and mitigating factor affects whether a period of exclusion is unreasonable, i.e., outside the reasonable range.  Clearly, determining a reasonable range is not a simple process of counting the aggravating and mitigating factors, and considerable discretion remains for the Board and the ALJ to engage in the weighing process to decide what is unreasonable, although that weighing is significantly

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limited by the language of 42 C.F.R. § 1001.2007(a)(1)(ii) and the Board's prior decisions on how the regulation is to be implemented.  The IG determination of the weight given aggravating and mitigating factors is clearly entitled to receive some deference due to the regulatory standard for review adopted by notice and comment rulemaking; by regulation, the issue is whether the period of exclusion is unreasonable.  42 C.F.R. § 1001.2007(a)(1)(ii).  No further deference is required by the Act or regulations or recognized by the Board.  In this case, however, it has not been shown that the IG considered an aggravating factor that did not exist or failed to consider a mitigating factor that did exist.  Therefore, I have no discretion to reassess the period of exclusion under current Board decisions.

Based on my de novo review, I conclude that a basis for exclusion exists and that the undisputed evidence establishes four aggravating factors and no mitigating factor.  The IG in selecting a 20-year exclusion, did not consider an aggravating factor that did not exist or fail to consider a mitigating factor that did exist based on the undisputed evidence.  IG Ex. 1.  Petitioner argues that the IG did not properly weigh the aggravating and mitigating factors in this case in determining to extend the period of exclusion by 15 years.  P. Br. at 15-19; P. Reply at 3-4.  However, no basis exists for me to reassess the period of exclusion in this case.  I conclude that a period of exclusion of 20 years is within a reasonable range and not unreasonable considering the existence of the four aggravating factors and no mitigating factor.

Petitioner argues that his 20-year exclusion is punitive and that I should reweigh the aggravating factors to determine a reasonable period.  P. Br. at 15-19; P. Reply at 4.  I have already explained I have no discretion to reweigh the aggravating factors in this case.5  Petitioner's argument may also be construed to be that his exclusion is a cruel and unusual punishment that violates the Constitutional prohibition of such punishment.  U.S. Const. amend. VIII.  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.

Page 26

Sullivan, 731 F. Supp. 838 (E.D. Tenn. 1990); Joann Fletcher Cash, DAB No. 1725 (2000); Douglas Schram, R.Ph., DAB No. 1372 (1992); and Janet Wallace, L.P.N., DAB No. 1326 (1992).6  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, though not all, federal courts have rejected claims that the Secretary's exclusion procedures amount to a deprivation of due process, finding no constitutionally protected property or liberty interests.  Shah v. Azar, 920 F.3rd 987, 998 (5th Cir. 2019); 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).  Accordingly, I conclude that Petitioner's possible constitutional arguments are without merit.

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 federal health care programs for 20 years effective May 20, 2025.

/s/

Keith W. Sickendick Administrative Law Judge

  • 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.  Regulatory citations are to the 2024 revision of the Code of Federal Regulations which was in effect when the IG excluded Petitioner.

  • 2

    Petitioner filed with his sur-reply a document marked “Exhibit 1.”  The document filed with the sur-reply is a copy of the document previously filed as P. Ex. 8.  P. Reply at 3 n.1.  Filing another copy of P. Ex. 8 with the sur-reply is confusing, particularly because the document has a different exhibit number that duplicates the number placed by Petitioner on a different document previously filed.  Therefore, the document filed with the sur-reply is not considered further.  But the copy of the same document marked P. Ex. 8 is considered.

  • 3

    The Secretary is granted limited authority to waive exclusion under section 1128(a).  Act § 1128(c)(3)(B).  But there is no evidence before me that permits an inference that the limited circumstances under which the Secretary may consider a waiver are present in this case.  Moreover, a decision of the Secretary not to grant a waiver is not subject to review.

  • 4

    Citations are to IG Ex. 7 rather than P. Ex. 5 because the pages of P. Ex. 5 are not numbered as part of the exhibit marking.

  • 5

    If I could reweigh the aggravating factors and substitute my judgment for that of the IG, I would uphold exclusion for 20 years based largely upon the facts that Petitioner engaged in the conspiracy for a long period and his enrichment was significant.  Petitioner asserts he was suffering mental and emotional distress, nevertheless there is no dispute that he continued to see patients and ordered tests despite being unable to discern good from bad indicating that he may not be trustworthy to continue participating in Medicare or Medicaid now or in the future.  But to be clear, I make no findings in this regard and do not attempt to substitute my judgement for that of the IG.

  • 6

    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.

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