Chaim Charles Steg, DAB No. 3115 (2023)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Chaim Charles Steg (Petitioner) appeals a decision of an Administrative Law Judge (ALJ) upholding the determination of the Inspector General (I.G.) to exclude Petitioner from participating in all federal health care programs for a minimum period of 15 years under section 1128(a)(2) of the Social Security Act (Act).¹  Chaim Charles Steg, DAB CR6295 (2023) (ALJ Decision).  The ALJ found Petitioner was convicted of a criminal offense relating to neglect or abuse of patients in connection with the delivery of a health care item or service.  Specifically, the ALJ found Petitioner, the regional director of a nursing facility, pleaded nolo contendere to three counts of reckless endangerment in connection with the serious bodily injury and death of three facility residents.  The ALJ further found that the length of the exclusion imposed by the I.G. was not unreasonable based on the application of two aggravating factors and no mitigating factors.  We affirm the ALJ Decision because it is supported by substantial evidence and free of legal error.

Legal Background

Section 1128(a)(2) of the Act requires that the Secretary of the Department of Health and Human Services (Secretary) exclude from participation in all federal health care programs any individual that “has been convicted, under Federal or State law, of a criminal offense relating to neglect or abuse of patients in connection with the delivery of a health care item or service.”  Act § 1128(a)(2); see also 42 C.F.R. § 1001.101(b).² 

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An individual is considered “convicted” within the meaning of section 1128(a) when, among other things, “a judgment of conviction has been entered against the individual . . . by a Federal, State, or local court” or “when a plea of guilty or nolo contendere by the individual . . . has been accepted by a Federal, State, or local court.”  Act § 1128(i)(1), (3); see also 42 C.F.R. § 1001.2 (defining “Convicted”).  “It is the fact of the conviction which causes the exclusion.”  Peter J. Edmonson, DAB No. 1330, at 4 (1992) (underlining replaced by italics).  The general purpose of section 1128 is to provide “protection for federally funded programs and their beneficiaries and recipients” by excluding “potentially untrustworthy individuals or entities based on criminal convictions.”  Id. 

An exclusion imposed under section 1128(a)(2) must be for a minimum period of five years.  Act § 1128(c)(3)(B); see also 42 C.F.R. § 1001.102(a).  The I.G. may extend the exclusion period beyond the statutory minimum if certain aggravating factors, as described in the regulations, are present.  42 C.F.R. § 1001.102(b).  Two of those factors are relevant here:

• The acts that resulted in the conviction, or similar acts, had a significant adverse physical, mental or financial impact on one or more program beneficiaries or other individuals;
• The sentence imposed by the court included incarceration.

Id. § 1001.102(b)(3), (5).  If one or more aggravating factors justify an exclusion longer than the statutory minimum, then certain mitigating factors as specified in the regulation may be considered as a basis for reducing the exclusion period to no less than five years.  Id. § 1001.102(c).

An excluded individual may request a hearing before an ALJ, but only on the issues of (i) whether the “basis for” exclusion exists, and (ii) whether “[t]he length of exclusion is unreasonable.”  42 C.F.R. §§ 1001.2007(a), 1005.2(a).  The underlying conviction is not reviewable or subject to collateral attack on substantive or procedural grounds.  Id. § 1001.2007(d).  An ALJ is authorized to schedule a hearing; examine witnesses; and receive, rule on, and exclude or limit evidence.  Id. § 1005.4(b).  The ALJ issues an initial decision based on the record developed before the ALJ.  Id. § 1005.20(a).

A party dissatisfied with the ALJ’s initial decision may appeal that decision to the Board.  Id. § 1005.21(a).  Board review of an ALJ decision is, in general, based on the record developed before the ALJ.  See id. § 1005.21(f); Gracia L. Mayard, M.D., DAB No. 2767, at 6-8 (2017).    

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Case Background³

In March 2021, a criminal complaint was filed in Delaware County, Pennsylvania, charging Petitioner with three counts of recklessly endangering another person.  I.G. Ex. 5, at 1‑2 (citing 18 Pa. Const. Stat. § 2705).  The complaint alleged that “[Petitioner] did recklessly engage in conduct which placed B.W., O.D., and L.C. in danger of death or serious bodily injury.”  Id. at 2.  The complaint was supported by an Affidavit of Probable Cause (Affidavit) submitted by a special agent with the Pennsylvania Office of Attorney General, Bureau of Criminal Investigations, Medicaid Fraud Control Section, Care Dependent Neglect Team.  ALJ Decision at 2; I.G. Ex. 5, at 4-6.

The Affidavit explained that, for more than three years, the Pennsylvania Office of Attorney General investigated allegations of “widespread neglect and abuse” at Saint Francis Center for Rehabilitation and Healthcare (St. Francis), a nursing facility.  I.G. Ex. 5, at 4 (¶ 2).  The Affidavit alleged that Petitioner was the regional director of operations at St. Francis and that his reckless and unjustified decision-making caused serious bodily injury to three St. Francis residents, eventually resulting in their deaths.  ALJ Decision at 3; I.G. Ex. 5, at 4 (¶ 2).  The Affidavit stated that Petitioner “acted as the highest decision-making authority for St. Francis and was responsible for the reckless decisions resulting in the residents’ serious injuries primarily because of a lack of appropriate staffing in the facility.”  I.G. Ex. 5, at 4 (¶ 2).

The Affidavit identified the three deceased residents by their initials: B.W., O.D., and L.C.  ALJ Decision at 3; I.G. Ex. 5, at 4-5 (¶¶ 4-6).  B.W. died from an infection caused by a massive obstruction in her colon and dehydration that staff at St. Francis failed to properly identify and treat.  ALJ Decision at 3; I.G. Ex. 5, at 4 (¶ 4).  O.D. died from septic shock and severe dehydration while suffering from improperly treated Stage IV pressure ulcers that exposed his tendon and bone.  ALJ Decision at 3; I.G. Ex. 5, at 4-5 (¶ 5).  L.C. died from a bacterial infection in the blood after suffering from a sacral wound that was not discovered by staff until it penetrated to the deeper structures of her body due to a lack of appropriate care.  ALJ Decision at 3; I.G. Ex. 5, at 5 (¶ 6).

The Affidavit alleged that all three residents suffered from conditions that should have been identified and routinely treated by St. Francis staff.  ALJ Decision at 3; I.G. Ex. 5, at 5 (¶ 7).  According to the Affidavit, all three residents were neglected and eventually died from their untreated conditions.  ALJ Decision at 3; I.G. Ex. 5, at 4-5 (¶¶ 4-8).  The Affidavit further alleged that the residents’ deaths were not isolated incidents but were the consequence of systemic failures at the facility to provide appropriate care.  ALJ Decision at 3; I.G. Ex. 5, at 5 (¶ 7).

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The Affidavit connected Petitioner’s decision-making to the deaths of the three residents:

Despite making multi-million dollar annual profits, . . . [Petitioner], as Regional Director of Operations at St. Francis, recklessly chose not to adequately invest in adequate staffing and did not adjust other operational factors within his control to mitigate the ongoing staffing crisis.  St. Francis was understaffed on a daily basis for months at a time and much of the staff that they did have was inexperienced and not sufficiently trained.  The facility suffered from incredibly high turnover amongst the nursing staff and relied heavily on outside agency caretakers who were unfamiliar with St. Francis residents and procedures.

ALJ Decision at 3-4 (quoting I.G. Ex. 5, at 5 (¶ 8)).  The Affidavit further alleged that Petitioner was well-aware of the staffing problems at St. Francis and, despite repeated complaints by lower-level managers and staff, never properly addressed them due to financial concerns.  ALJ Decision at 4; I.G. Ex. 5, at 5-6 (¶¶ 9-11).

In response to the charges, Petitioner waived the right to a preliminary hearing and agreed to plead nolo contendere (no contest) to three counts of reckless endangerment in the Court of Common Pleas.  I.G. Ex. 3 (Waiver); I.G. Ex. 4 (Supplement to Waiver).  The plea agreement noted:  “The Commonwealth acknowledges that acceptance of the defendant’s nolo contendere plea by the Court of Common Pleas is not intended to exclude the defendant . . . from participation in the Medicare or state health care program under 42 C.F.R. § 1001.101 et. seq.  The Commonwealth takes no position on any action by any other government agency.”  I.G. Ex. 4, at 2 (¶ 4).  The Information filed in the Court of Common Pleas charged Petitioner with three counts of recklessly endangering another person, specifically St. Francis residents B.W., O.D., and L.C.  I.G. Ex. 2 (Information).

On June 2, 2021, Petitioner pleaded nolo contendere to all three counts charged in the Information.  ALJ Decision at 2; I.G. Ex. 6.  In doing so, Petitioner acknowledged that his plea of nolo contendere “will have the same effect in criminal law as if [he] had a trial and was convicted of the crimes.”  I.G. Ex. 6, at 4 (¶ 21).  Petitioner further acknowledged that, by pleading nolo contendere to each of the three counts, he does “not contest that [he] committed each element of these crimes” and agrees “that the Commonwealth can prove that [he] committed each element of these crimes beyond a reasonable doubt.”  Id. at 4-5.  During the plea hearing, Petitioner acknowledged, through counsel, that the allegations stated in the Affidavit, if proven, would establish the crimes to which he entered his plea of nolo contendere.  ALJ Decision at 2; I.G. Ex. 7, at 14 (“There is a factual basis [for the plea], we will stipulate to the Affidavit of Probable Cause, insofar as the allegations support the predicate offenses.”).  The Court of Common Pleas accepted Petitioner’s plea and scheduled a date for sentencing.  I.G. Ex. 7, at 15-18.

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On December 2, 2021, the court sentenced Petitioner to six to 23 months of home arrest with electronic monitoring and three years of probation, and further ordered Petitioner to pay a fine as well as restitution to the families of each victim.  I.G. Ex. 8.  As a condition of his probation, Petitioner was prohibited from (i) serving as the licensed administrator of a skilled nursing facility, or in any other capacity that requires such licensure; (ii) having any control over the nursing, clinical, or medical services or staffing at a skilled nursing facility; and (iii) owning a majority equity interest in any operator of a skilled nursing facility, or in any skilled nursing facility.  Id.

By letter dated November 30, 2022, the I.G. notified Petitioner that he was being excluded from participation in all federal health care programs for a minimum period of 15 years.  I.G. Ex. 1 (Exclusion Notice), at 1.  The I.G. explained that Petitioner was being excluded under the mandatory exclusion provision in section 1128(a)(2) of the Act due to his conviction in the Court of Common Pleas “of a criminal offense related to the neglect or abuse of a patient, in connection with the delivery of a health care item or service.”  Id.  The I.G. further explained that Petitioner’s exclusion period was extended beyond the minimum five years based on two aggravating factors:  (i) the acts that resulted in the conviction had a significant adverse physical, mental, or financial impact on one or more individuals (i.e., by failing to address operational deficiencies at St. Francis, Petitioner recklessly endangered residents by placing them in danger of death or serious bodily injury); and (ii) the sentence imposed by the court included six to 23 months of incarceration in the form of home confinement with electronic monitoring.  Id.

ALJ Proceedings and Decision

Petitioner requested an ALJ hearing challenging both the basis for and the length of the exclusion.  ALJ Decision at 1.  The I.G. filed a brief, a reply brief, and eight exhibits (I.G. Exs. 1-8).  Petitioner filed a brief, subsequently amended, and 10 exhibits (P. Exs. 1-10).  Petitioner offered written testimony in the form of an affidavit (P. Ex. 2), which the ALJ excluded as an impermissible collateral attack on Petitioner’s conviction.  ALJ Decision at 2, 5.  The ALJ received into evidence all other exhibits proffered by the parties.  Id. at 2.  The ALJ determined an in-person hearing was unnecessary and issued a decision based on the written record.  Id. at 2, 5.⁴

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The ALJ determined that the I.G. had a basis to exclude Petitioner under section 1128(a)(2) of the Act because Petitioner was convicted of a criminal offense relating to neglect or abuse of patients in connection with the delivery of a health care item or service.  ALJ Decision at 2, 3-6.  The ALJ further determined that the two aggravating factors cited by the I.G. under 42 C.F.R. § 1001.102(b)(3) and (b)(5) supported extending Petitioner’s exclusion period and that Petitioner had presented no evidence of any cognizable mitigating factor under 42 C.F.R. § 1001.102(c).  Id. at 6-9.  The ALJ determined that the 15-year exclusion falls within a reasonable range based on the application of the two aggravating factors and no mitigating factors.  Id. at 7-9.  This appeal followed.

Standard of Review

The Board reviews a disputed issue of fact as to whether the ALJ “decision is supported by substantial evidence on the whole record.”  42 C.F.R. § 1005.21(h).  The Board reviews a disputed issue of law as to whether the ALJ decision “is erroneous.”  Id.  The term “substantial evidence” means “such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.”  Ellen L. Morand, DAB No. 2436, at 3 (2012) (quoting Richardson v. Perales, 402 U.S. 389, 401 (1971) (quoting Consolidated Edison Co. v. NLRB, 305 U.S. 197, 229 (1938))).

Analysis

Before the Board, Petitioner again challenges the legal basis for his exclusion and the length of his exclusion.  First, Petitioner argues that there is no basis for the exclusion because “his misdemeanor conviction did not relate to patient abuse or neglect.”  Brief of Appellant in Support of Appeal (P. Br.) at 4.  Second, Petitioner asserts that “the length of the exclusion, 15 years, is unreasonable and should be reduced.”  Id.  As further explained below, we reject Petitioner’s arguments and conclude that the ALJ Decision is supported by substantial evidence and free of legal error.  In Section I, we address whether the I.G. had a valid basis to exclude Petitioner under section 1128(a)(2) of the Act.  In Section II, we address Petitioner’s arguments regarding the length of the exclusion.

I. The ALJ’s conclusion that there is a basis for Petitioner’s mandatory exclusion under section 1128(a)(2) of the Act is supported by substantial evidence and free of legal error.

Section 1128(a)(2) requires the I.G. to exclude any individual that has been convicted of a criminal offense relating to neglect or abuse of patients in connection with the delivery of a health care item or service.  Act § 1128(a)(2); see also 42 C.F.R. § 1001.101(b).  Petitioner does not dispute that he was “convicted” of a criminal offense within the meaning of the Act § 1128(i) when he entered a plea of nolo contendere.  P. Br. at 5. 

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Petitioner argues, however, that his exclusion is not mandated because his offense “did not contemplate his exclusion from government healthcare programs, nor did it relate to patient abuse or neglect.”  Id.  According to Petitioner, his plea agreement “specifically stated that he would not be excluded from the Medicare Program.”  Id.  Petitioner further argues that the ALJ misapprehended the nature of his nolo contendere plea because he “did not admit to committing an illegal act or stipulate to the accuracy of the facts” in the Affidavit.  Id. at 7.  Petitioner further asserts that the criminal statute under which he was convicted, 18 Pa. Const. Stat. § 2705, does not require patient abuse or neglect and, unlike other individuals excluded under section 1128(a)(2), he did not have “direct patient contact.”  Id. at 8-9.  Petitioner further complains that the ALJ should not have excluded his affidavit (P. Ex. 2) and should have considered Petitioner’s “actual role at the facility.”  Id. at 8.  We reject each of Petitioner’s arguments and find that substantial evidence in the record supports the ALJ’s conclusion that Petitioner’s offense (i.e., recklessly endangering three residents of St. Francis) related to the neglect of patients in connection with the delivery of a health care item or service.

1. A. Petitioner’s criminal offense related to the neglect of patients in connection with the delivery of a health care item or service.

When, as here, a conviction has been established, “the basic question in a section 1128(a)(2) exclusion case is simply whether there is a common sense nexus between the underlying offense and potential or actual harm to the health and well-being of a patient in the course of health care delivery.”  Robert C. Hartnett, DAB No. 2740, at 7 (2016).  “[T]he conviction is not required to be for patient neglect or abuse, but rather the circumstances that surrounded the actual offense need only show a relation to the neglect or abuse of a patient.”  Narendra M. Patel, DAB No. 1736, at 10 (2000), aff’d, Patel v. Thompson, 319 F.3d 1317 (11th Cir. 2003), cert. denied, 539 U.S. 959 (2003).  In determining whether the requisite nexus exists, ALJs are “not limited to considering the bare elements or labels of the criminal statutes under which the individual was convicted.”  Funmilola Mary Taiwo, DAB No. 2995, at 8 (2020) (citing Summit S. Shah, DAB No. 2836, at 7 (2017) (“The Board has long held . . . that an ALJ is free to look beyond the narrow constructs of a state’s criminal statutes.”); Patel, DAB No. 1736, at 10 (Congress did not intend to limit the I.G.’s exclusion authority through “dependence on the vagaries of state criminal law definitions or record development”).  Rather, ALJs “may look at ‘evidence as to the nature of an offense’ such as ‘facts upon which the conviction was predicated.’”  Taiwo at 8 (quoting Shah at 7); see also Michael S. Rudman, M.D., DAB No. 2171, at 9 (2008) (“[E]vidence regarding the nature of the offense, rather than the state’s labeling of the offense” is considered to determine whether the offense “involved conduct warranting exclusion.”), aff’d, 578 F. Supp. 2d 812 (D. Md. 2008).

“Moreover, in evaluating the nature of the offense and predicate for the underlying conviction, ALJs are not limited to considering only those facts established in the

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underlying criminal proceedings.”  Shelia Ann Reed, DAB No. 3059, at 15 (2022).  “ALJs may, among other things, look to ‘the factual allegations underpinning the offense with which a petitioner was charged and which form the basis for the requisite conviction.’”  Id. (quoting Hartnett, DAB No. 2740, at 7).  In this regard, ALJs may consider the allegations in documentary evidence, such as an arrest warrant affidavit, prosecution memorandum, or criminal complaint to determine whether the conduct underlying the offense met the elements of the exclusion law.  See, e.g., Reed at 16-18 (affirming ALJ’s conclusion that petitioner’s conviction for disorderly conduct related to the neglect of a patient based, in part, on allegations in state investigator’s arrest warrant affidavit); Nancy L. Clark, DAB No. 2989, at 8-10 (2020) (affirming ALJ’s reliance on prosecution memorandum and declaration summarizing investigative findings of an assistant attorney general in finding the requisite nexus between petitioner’s offense and patient neglect or abuse); Hartnett at 7-9 (affirming ALJ’s finding that petitioner’s conviction related to neglect of a patient based on allegations in criminal complaint).

In examining the facts and circumstances underlying Petitioner’s conviction, we find substantial evidence in the record supports the ALJ’s conclusion that Petitioner’s offense related to the neglect of patients in connection with the delivery of a healthcare item or service.  ALJ Decision at 2-5.  Petitioner was charged with recklessly engaging in conduct which placed three residents of St. Francis, identified as L.C., O.D., and B.W., in danger of death or serious bodily injury.  I.G. Ex. 2.  Petitioner did not contest these charges and entered a plea of nolo contendere.  I.G. Ex. 2; I.G. Ex. 6, at 4-5 (¶ 23).  At the plea hearing, Petitioner acknowledged, through counsel, that the allegations in the Affidavit provided the factual basis for his plea.  ALJ Decision at 2; I.G. Ex. 7, at 14 (“There is a factual basis [for the plea], we will stipulate to the Affidavit of Probable Cause, insofar as the allegations support the predicate offenses.”). 

As the ALJ found, the Affidavit “provides an unassailable fact basis for finding that Petitioner’s conviction was of patient neglect or abuse within the meaning of section 1128(a)(2) of the Act.”  ALJ Decision at 3.  Focusing on the uncontested allegations in the Affidavit, the ALJ explained:

The allegations that are the basis for Petitioner’s nolo contendere plea thus draw a straightforward connection between Petitioner’s actions and the deaths of three residents at St. Francis.  Petitioner’s convictions relate to patient neglect or abuse within the meaning of section 1128(a)(2) because his decisions as Regional Director of St. Francis had a direct impact on the neglect suffered by the residents.  Those decisions were also directly related to the delivery, or in this case, the non-delivery, of health care services to the residents.  Stated succinctly, the allegations to which Petitioner entered his plea are that these residents suffered needlessly and likely died due to Petitioner’s decisions that deprived them of necessary and appropriate care.

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Id. at 4.  The Affidavit, as the ALJ found, “makes it clear that the neglect suffered by the three residents was the direct consequence of Petitioner’s decisions.”  Id. at 5.  “Patient neglect is thus an integral part of the crimes to which [Petitioner] entered his plea and of which he was convicted.”  Id.  Moreover, Petitioner made no showing that the three counts of recklessly endangering the three St. Francis residents, specifically identified as L.C., O.D., and B.W. (I.G. Ex. 2), emanated from facts or allegations different from those set forth in the Affidavit.⁵  Accordingly, we find no error in the ALJ’s assessment of the record evidence and conclude that substantial evidence supports the ALJ’s finding that Petitioner’s criminal offense related to patient neglect in connection with the delivery of a health care item or service.

We reject Petitioner’s assertions that the ALJ “misapprehend[ed] the nature” of Petitioner’s nolo contendere plea and believed that Petitioner “must have admitted to the veracity of the facts” in the Affidavit.  P. Br. at 6-7.  Contrary to Petitioner’s assertion, the ALJ acknowledged that Petitioner’s plea was “not an explicit admission of guilt”; however, the ALJ correctly determined that Petitioner did not “contest the allegations of criminal conduct” to which he entered his plea.  ALJ Decision at 4; see also I.G. Ex. 6, at 1 (“By pleading nolo contendere, you are stating that you do not contest the fact that you committed the crimes.”).  Moreover, the lack of an express admission by Petitioner did not preclude the ALJ from finding a common-sense nexus between Petitioner’s offense and potential or actual harm to the health and well-being of patients in the course of health care delivery based on the totality of the evidence.  See Hartnett at 9-10 (rejecting argument that the elements of a section 1128(a)(2) exclusion cannot be satisfied absent an express admission of specific wrongdoing in petitioner’s plea agreement or plea colloquy).  Thus, we reject Petitioner’s suggestion that there can be no legal basis for his exclusion under section 1128(a)(2) absent evidence that he stipulated to the veracity of the allegations in the Affidavit.  Id.  As the Board previously explained:

We . . . see nothing in section 1128(a)(2) that requires that the necessary elements of the criminal offense must mirror the elements of the exclusion authority, nor that all statutory elements required for an exclusion must be contained in the findings or record of the state criminal court.  . . . On the

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contrary, the statutory language says nothing about what evidence of the nature of and circumstances surrounding the offense itself may be considered to determine if the individual’s criminal conduct included the elements necessary for a mandatory exclusion.

Id. (quoting Patel at 10).  As explained above, substantial evidence in the record plainly connects Petitioner’s offense to patient neglect.

We further reject Petitioner’s contention that his offense did not require exclusion because the criminal statute under which he was convicted, 18 Pa. Const. Stat. § 2705, does not require a finding of patient neglect or abuse and a different Pennsylvania statute, 18 Pa. Const. Stat. § 2713, addresses neglect of a care-dependent person.  P. Br. at 8-9.  Petitioner’s narrow focus on the statutory elements of the offense rather than the facts and circumstances underlying his conviction contradicts Board precedent.  See Shaun Thaxter, DAB No. 3053, at 22 (2021) (“The Board has repeatedly held that the basis for an exclusion stems from the nature and circumstances of the underlying conviction, not the label or even the elements of the crime.”); see also Taiwo at 8 (collecting cases).  Here, the ALJ was not limited to looking only at the criminal statute under which Petitioner was convicted, but appropriately considered evidence of the facts and allegations upon which Petitioner’s conviction was based.  See Taiwo at 8.  Thus, we find no error in the ALJ’s conclusion that the statutory elements of a criminal offense do not control whether an offense is “related to” patient neglect or abuse.  ALJ Decision at 5 (“I need not draw inferences from statutory language to identify the elements of Petitioner’s crime.”). 

Petitioner’s further contention that his exclusion is unwarranted because he did not have “direct patient contact” has no basis in the language of section 1128(a)(2).  P. Br. at 9.  Nothing in the language of section 1128(a)(2) requires that the convicted individual have had some type of direct participation in the delivery of a health care item or service.  “[T]he Board has long held that it will not ‘read into the exclusion provisions requirements that are not contained in the literal language of the law.’”  Thaxter at 15 (citation omitted).  Moreover, we are unaware of any legal authority that would preclude the I.G. from excluding an individual under section 1128(a)(2) merely because the individual was not directly involved in patient care.  Cf. Carolyn Westin, DAB No. 1381, at 1-2, 22 (1993) (affirming exclusion under section 1128(a)(2) of a nursing home administrator, who was not directly involved in patient care, based on a conviction arising from the failure to report the injury and death of a resident), aff’d, 845 F. Supp. 1446 (D. Kan. 1994).  Thus, we reject Petitioner’s attempt to read into section 1128(a)(2)

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a requirement that Petitioner’s offense must include an element of direct patient contact.⁶   As the Board noted in Hartnett, the question is “whether there is a common sense nexus between the underlying offense and potential or actual harm to the health and well-being of a patient in the course of health care delivery.”  Hartnett at 7.  Here, the ALJ concluded that the Affidavit “makes it clear that the neglect suffered by the three residents was the direct consequence of Petitioner’s decisions,” which “were part of the chain of delivery of health care items or services to the three residents whose care underlies the charges filed against Petitioner.”  ALJ Decision at 5.  We find no error in the ALJ’s conclusion. 

2. B. Petitioner’s plea agreement did not preclude his mandatory exclusion.

Petitioner asserts that there is no basis for his exclusion because his plea agreement “specifically indicates” that his conviction is not one that requires mandatory exclusion.  P. Br. at 6.  Petitioner points to one sentence in the plea agreement, stating that: “The Commonwealth acknowledges that acceptance of the defendant’s nolo contendere plea by the Court of Common Pleas is not intended to exclude the defendant or any skilled nursing facility in which he retains a non-majority ownership interest from participation in the Medicare or state health care program under 42 C.F.R. § 1001.101 et seq.”  Id. at 5 (quoting I.G. Ex. 4, at 2).  Petitioner’s brief omitted the next sentence:  “The Commonwealth takes no position on any action by any other government agency.”  I.G. Ex. 4, at 2 (¶ 4).  The plea agreement, therefore, expressly acknowledged that whatever the Commonwealth’s prosecuting officials may have “intended” in terms of the collateral consequences of Petitioner’s nolo contendere plea, those intentions have no bearing on what other government actors who are not parties to the agreement (such as the I.G.) may impose or may be required to impose.  As the ALJ correctly determined, state officials have no authority to restrain the I.G. from excluding Petitioner under the mandatory exclusion provisions in the Act.  ALJ Decision at 6 (“There is nothing in law that allows a state official to make decisions that limit the mandatory exclusion authority vested by Congress in the Secretary . . . .”).

Section 1128 of the Act is a federal statute which Congress enacted to provide civil remedies independent from punishments which might be applied to individuals or entities

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under state criminal laws.  Nothing in section 1128 suggests that Congress intended that the duty to impose exclusions, which was vested in the Secretary and delegated to the I.G., be subject to limitations imposed by state prosecutors.  Indeed, the Board has long held that state prosecutors have no authority to restrain the Secretary (nor the I.G.) from exercising the duty to impose an exclusion required by federal law.  See Anthony Accaputo, Jr., DAB No. 1416, at 3-4 (1993) (holding that state officials have no authority to preclude the I.G. from exercising its duty to impose a mandatory exclusion through a plea agreement); Louis Mathews, DAB No. 1574, at 4 n.4 (1996) (“[T]he circumstances of Petitioner’s conviction and any agreement he had with the state prosecuting officers were not relevant to this exclusion proceeding.”).  As explained above, substantial evidence in the record supports the ALJ’s finding that Petitioner’s criminal offense related to patient neglect in connection with the delivery of a health care item or service.  Nothing in the plea agreement changes that assessment.    

3. C. The ALJ did not err by excluding Petitioner’s affidavit.

Petitioner challenges the ALJ’s exclusion of his affidavit (P. Ex. 2), noting that it should have been considered because it shows he was not an employee or regional director of St. Francis but only a consultant with no “onsite patient interaction.”  P. Br. at 2, 8 n.2.  Petitioner asserts that, at a minimum, this matter should be remanded to the ALJ for further fact-finding regarding Petitioner’s “actual role at the facility.”  Id. at 8.  In other words, Petitioner is attempting to argue, despite his conviction, that he has no criminal responsibility.   

“The governing regulations grant ALJs broad authority to ‘determine the admissibility of evidence.’”  Clark at 8 (quoting 42 C.F.R. § 1005.17(a)).  ALJs “must exclude irrelevant or immaterial evidence.”  42 C.F.R. § 1005.17 (c); see also CRD Procedures § 20.  The Board defers to the evidentiary rulings of ALJs unless there is a compelling reason not to do so.  Clark at 8-9 (citing HeartFlow, Inc., DAB No. 2781, at 19 (2017)).  Here, Petitioner’s conviction for recklessly endangering three residents of St. Francis was the basis for his exclusion.  Act § 1128(a)(2); see also I.G. Ex. 1.  Having been convicted, Petitioner is precluded from re-litigating the criminal charges in administrative proceedings before the ALJ or the Board.  See 42 C.F.R. § 1001.2007(d) (“When the exclusion is based on the existence of a criminal conviction . . . the basis for the underlying conviction . . . is not reviewable and the individual or entity may not collaterally attack it either on substantive or procedural grounds . . . .”); see also Adel A. Kallini, M.D., DAB No. 2944, at 6 n.3 (2019) (“[I]n challenging an exclusion or sanction based on, or derivative of, a prior criminal conviction, the respondent is precluded from collaterally attacking the factual or procedural elements of the underlying offense.”).  

The question before the ALJ was not whether Petitioner was, in fact, the regional director of St. Francis, but whether the offense Petitioner was convicted of related to the neglect or abuse of a patient in connection with the delivery of a health care item or service.  

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Recognizing that Petitioner was not permitted to collaterally attack the basis for his conviction, the ALJ appropriately determined that Petitioner’s affidavit amounted to an impermissible collateral attack on the facts underlying his conviction.  ALJ Decision at 5.  Petitioner has provided no compelling reason to depart from the Board’s long-standing practice of deferring to ALJs as to evidentiary matters, and we find no error in the ALJ’s decision to exclude Petitioner’s affidavit (I.G. Ex. 2) because the proffered testimony was not relevant to any issue before the ALJ. 

II. The ALJ’s determination that a 15-year exclusion is reasonable is supported by substantial evidence and free of legal error.

In analyzing the duration of an exclusion period longer than the five-year statutory minimum, the ALJ’s role is to “‘review[] the length of an exclusion de novo to determine whether it falls within a reasonable range, given the aggravating and mitigating factors and the circumstances underlying them.’”  Rosa Velia Serrano, DAB No. 2923, at 8 (2019) (quoting Sushil Aniruddh Sheth, M.D., DAB No. 2491, at 5 (2012)).  “Such an 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.’”  Kimberly Jones, DAB No. 3033, at 7 (2021) (quoting Sheth at 5).  “An ALJ may not substitute [their] judgment for that of the I.G. or determine a ‘better’ exclusion period.”  Id. at 8 (quoting Sheth at 5).  “Instead, the ALJ’s role is limited to considering whether the period of exclusion imposed by the I.G. was within a reasonable range, based on demonstrated criteria.”  Craig Richard Wilder, M.D., DAB No. 2416, at 8 (2011); see also 57 Fed. Reg. 3298, 3321 (Jan. 29, 1992) (deference to I.G.’s “broad discretion” in setting the length of an exclusion “is appropriate, given the [I.G.’s] vast experience in implementing exclusions”).

Our review of the ALJ Decision is likewise governed by the same regulatory standards.  We do not review the I.G.’s decision-making process in setting the length of an exclusion.  See Edwin L. Fuentes, DAB No. 2988, at 11 (2020), aff’d, No. 4:20-cv-26, 2021 WL 4341115 (W.D. Va. Sept. 23, 2021).  Rather, “[w]e review whether the outcome of that process (the exclusion period set by the I.G. and affirmed by the ALJ) is unreasonable in light of the facts relating to the factors that the regulation specifies.”  Id. 

In accordance with governing regulations and Board precedent, the ALJ evaluated the reasonableness of Petitioner’s 15-year exclusion by reviewing the record to determine what the evidence established with regard to the aggravating factors identified by the I.G. and any mitigating factors.  ALJ Decision at 6-9.  To reiterate, those aggravating factors are:  (i) the acts resulting in Petitioner’s conviction had a significant adverse physical, mental, or financial impact on one or more program beneficiaries or other individuals; and (ii) Petitioner’s sentence included incarceration (specifically home confinement).  See I.G. Ex. 1, at 1; 42 C.F.R. § 1001.102(b)(3), (5).  The ALJ found the record evidence

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established the two aggravating factors and further determined that Petitioner established no mitigating factor under 42 C.F.R. § 1001.102(c).  ALJ Decision at 7-9.  The ALJ also rejected Petitioner’s comparative analysis based on exclusions imposed in other cases involving financial crimes.  Id. at 8-9 (“His crimes may have been financially motivated in the sense that he was attempting to maximize his facility’s profits, but their impact was directly on the health and safety of residents.  The exclusion period is easily justified by considering that impact in light of Petitioner’s motivation.”).  Thus, based on a qualitative assessment of the circumstances surrounding the aggravating factors (and no mitigating factors), the ALJ concluded that the length of the exclusion – 15 years – falls within a reasonable range.  Id. at 7-9.

Petitioner does not dispute the existence of the two aggravating factors but complains that a 15-year exclusion is unreasonable for someone who “never had any direct patient contact and who has not committed healthcare fraud.”  P. Br. at 10.  According to Petitioner, he cannot be deemed untrustworthy to provide care because he “is not, and has never been a healthcare provider.”  Id.  Petitioner further alleges that in “recent years,” the I.G. has imposed 15-year exclusions “only in extreme cases” involving healthcare fraud.  Id. at 11.  We reject each of Petitioner’s arguments and affirm the ALJ’s conclusion that the 15-year exclusion falls within a reasonable range because it is supported by substantial evidence and free of legal error.

1. A. The aggravating factor regarding a significant adverse impact on individuals was established by substantial evidence and weighs heavily in favor of extending the mandatory period of exclusion.

Regarding the aggravating factor in section 1001.102(b)(3), the ALJ found that the acts that resulted in Petitioner’s conviction “had a significant adverse physical, mental, or financial impact on one or more program beneficiaries or other individuals.”  ALJ Decision at 7.  The ALJ noted that the Affidavit “makes it plain that the three St. Francis residents whose deaths are the predicate for the charges of reckless endangerment suffered as the proximate result of Petitioner’s decisions.”  Id. (citing I.G. Ex. 5, at 4-5). 

Petitioner does not directly address this aggravating factor, or the ALJ’s assessment of this factor.  To the extent Petitioner contends the ALJ should have given this aggravating factor less weight because Petitioner did not have “direct patient contact,” we reject that contention.  P. Br. at 10.  The question before the ALJ was whether the acts that led to Petitioner’s conviction for recklessly endangering three residents of St. Francis had a significant adverse physical, mental, or financial impact on them.  The ALJ found:

At the time of his conviction Petitioner offered no defense to allegations that his decisions as regional director of operations at St. Francis resulted in a systemic failure by that facility to provide care that met professional

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standards.  Nor did he contest allegations that those decisions led to residents suffering grievous harm and injuries that resulted in their deaths.

*      *      *      *

Suffice it to say that the allegations supporting the charges against Petitioner – allegations that Petitioner did not contest – assert explicitly that Petitioner’s decisions led to systemic failures at St. Francis that ultimately caused residents to die.  That is more than sufficient to sustain the IG’s exclusion determination as falling within a reasonable range.

ALJ Decision at 7.  Having determined that Petitioner’s conduct led to the grievous injuries and eventual death of three residents, the ALJ found this factor alone justified the length of the exclusion imposed by the I.G.  Cf. Michael J. Vogini, D.O., DAB No. 2584, at 9-10 (2014) (sustaining 25-year exclusion of physician who was convicted of prescribing controlled substances to a patient who subsequently died of an overdose based, in part, on ALJ’s finding of an adverse physical impact under section 1001.102(b)(3) established by the patient’s death).  We find no error in the ALJ’s qualitative evaluation of this aggravating factor or in assigning significant weight to it.⁷

2. B. Petitioner’s sentence, which included incarceration, also weighs in favor of extending the mandatory period of exclusion.

With respect to the aggravating factor in section 1001.102(b)(5) – that Petitioner’s sentence included incarceration – the ALJ found Petitioner’s sentence included six to 23 months of home arrest, which is “incarceration” as defined under 42 C.F.R. § 1001.2.  ALJ Decision at 7.⁸  The ALJ appropriately considered the length of incarceration ordered by the criminal court in finding that this factor weighs in favor of extending the exclusion period.  Id. (“The seriousness of Petitioner’s crimes and his lack of trustworthiness to provide care may be measured by the fact that he was ordered to be incarcerated for a substantial period of time – up to nearly two years of home confinement.”).⁹  Petitioner acknowledges that home arrest is a form of “incarceration”

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within the meaning of section 1001.102(b)(5) but argues that it is “not the type of incarceration” that would warrant a 15-year exclusion.  P. Br. at 11.  Petitioner notes that his conviction “involved no jail time and no pecuniary harm.”  Id.  We reject Petitioner’s arguments and find no error in the ALJ’s qualitative evaluation of the incarceration factor. 

To begin with, Petitioner’s 15-year exclusion was not based on the single aggravating factor of incarceration; rather, the ALJ found the presence of two aggravating factors and no mitigating factors justified extending the exclusion period to 15 years.  ALJ Decision at 6-9.  The ALJ’s assessment comports with the requirement that all established aggravating factors (and any mitigating factors) be evaluated together, to determine whether the length of an exclusion is reasonable.  See Sheth at 5 (holding that a proper evaluation of the reasonableness of the total length of exclusion “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”).  While some Board decisions have supported placing less weight on this factor if the sentence involved a type of confinement other than imprisonment, see Roji Esha, DAB No. 3076, at 30 (2022) (citing cases), the ALJ recognized that Petitioner was sentenced to home arrest (not imprisonment).  Petitioner has not shown that the ALJ gave this aggravating factor undue weight, particularly in light of the ALJ’s finding that the aggravating factor under section 1001.102(b)(3) supported the length of the exclusion. 

Moreover, “the focus of this aggravating factor . . . is the fact that the sentence included incarceration.”  See Gerald A. Snider, M.D., DAB No. 1637, at 8 (1997); see also Kimberly Jones at 8 (“Section 1001.102(b)(5) does not require proof of facts or circumstance other than that the sentence imposed by the court for a covered offense ‘included incarceration.’”).  This principle is reflected in Board decisions that have affirmed the lengthening of exclusion periods based in part on sentences that included incarceration of only a period of months.  See, e.g., Stacy Ann Battle, D.D.S., DAB No. 1843, at 7 (2002) (finding four months in a halfway house, followed by four months of home confinement, justified lengthening the exclusion period); Farzana Begum, M.D., DAB No. 2726, at 16 (2016) (noting that Petitioner’s sentence of incarceration, “even reduced to nine and a half months . . .  was relatively substantial”) (citation omitted), aff’d, No. 16-cv-9624, 2017 WL 5624388 (N.D. Ill. Nov. 21, 2017).  Thus, regardless of the type of incarceration, the ALJ did not err in relying on section 1001.102(b)(5) as a basis for upholding the I.G.’s extension of the exclusion period based on the undisputed fact that Petitioner’s sentence included “incarceration.”

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3. C. The ALJ properly rejected Petitioner’s contention that the length of his exclusion is excessive compared with exclusions imposed in other matters.

We next consider Petitioner’s contention that the ALJ wrongly rejected the argument that a 15-year exclusion is unreasonable based on exclusions imposed on other individuals in other matters.  P. Br. at 10-11.  Relying on a chart summarizing “cases” resulting in 15-year exclusions, Petitioner maintains that the I.G. has imposed such exclusions “only in extreme cases” typically involving fraud on federal health care programs.  Id. at 11 (citing P. Ex. 6).  Petitioner contends that his offense was unlike the “major federal convictions” summarized in the chart where the defendants caused “direct pecuniary harm” to federal programs and “received significant jail time.”  Id. at 11.

The Board has long rejected the kind of case comparison argument Petitioner is making here.  “[T]he assessment of aggravating and mitigating factors is qualitative, focusing on the circumstances of the case at hand, rather than quantitative or a matter of mathematical formulas . . . .”  Sheth at 8.  In reviewing whether the length of an exclusion exceeding the statutory minimum is unreasonable, “[c]omparisons with other cases are not controlling and of limited utility” because aggravating and mitigating factors do not have specific values and “must be evaluated based on the circumstances of a particular case . . . which can vary widely.”  Robert Hadley Gross, DAB No. 2807, at 6 (2017) (internal quotation marks omitted); see also Fuentes at 15 (“The Board has repeatedly explained that comparing exclusion periods is not generally helpful in assessing reasonableness, due in part to the varying mix of factors and wide range of relevant circumstances that may need to be considered in individual cases.”).  While case comparisons can “inform whether an exclusion falls within a reasonable range,” they are unhelpful to the Board’s decision-making unless supported by analysis that accounts for the unique circumstances of each case and the relative seriousness of any applicable aggravating and mitigating factors.  See Sheth at 6.

Here, the ALJ determined that “the reasonableness of an exclusion period does not depend on comparative analysis” and, in any event, the examples cited by Petitioner were not comparable to Petitioner’s case, which involved an exclusion under section 1128(a)(2) and evidence of two aggravating factors that “more than amply supports the exclusion period imposed by the I.G.”  ALJ Decision at 8.  None of the exclusion determinations in Petitioner’s chart were adjudicated by an ALJ or the Board and, in fact, many of the exclusions were imposed as part of a settlement agreement between the excluded individuals and the I.G.  P. Ex. 6.  Having never been adjudicated by the Board, the cited examples have no precedential value.  See Thaxter at 22 (“I.G. exclusion determinations are not ‘precedent’; even individual ALJ decisions reviewing I.G. exclusions do not create any binding legal precedent.”). 

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Still further, Petitioner presented no evidence that any of the cited examples involved acts having a significant adverse physical impact on one or more individuals as the ALJ found in this case.  ALJ Decision at 7 (noting the uncontested allegations that Petitioner’s decisions led to systemic failures that “ultimately caused residents to die”).  Although Petitioner points out that each of the cited examples involved a 15-year exclusion, Petitioner omits any discussion regarding the applicable aggravating factors and fails to account for the differences in Petitioner’s case.  Indeed, Petitioner does not even identify what aggravating factors were relied on by the I.G. in the cited examples.  Further, at no point in the administrative appeal process has Petitioner presented a meaningful comparative analysis to support the proposition that a 15-year exclusion is unreasonable given the seriousness of the existing aggravating factors in his case, particularly the aggravating factor under section 1001.102(b)(3).  Nor has Petitioner identified any Board decision involving the same aggravating circumstances present in this case (i.e., where the acts that resulted in the conviction led to grievous injuries and the deaths of three nursing home residents and a criminal sentence imposing up to nearly two years of home confinement) that required a period of exclusion shorter than the 15-year exclusion imposed here.  We find no error in the ALJ’s rejection of Petitioner’s argument that his 15-year exclusion is unreasonable in comparison to exclusions imposed in other matters under other circumstances.

As for Petitioner’s argument that his conviction involved no pecuniary harm to any federal program this fact, even if true, has no bearing on this case.  While financial loss to a government agency or program above a certain threshold is an aggravating factor, see 42 C.F.R. § 1001.102(b)(1), the I.G. did not rely on that factor here.  Moreover, the Board has long held that “the absence of an aggravating factor is not itself a mitigating factor.”  Eugene Goldman, M.D., DAB No. 2635, at 10 (2015).  As the ALJ found, Petitioner has identified no cognizable mitigating factors under section 1001.102(c) that would merit a reduction in the length of the exclusion.¹⁰

Based on the existence of two aggravating factors, both of which warrant significant weight, and the absence of any mitigating factor permitted by regulation, we find that the ALJ’s decision to sustain the 15-year exclusion imposed by the I.G. is supported by substantial evidence and comports with applicable law.

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Conclusion

For the reasons stated above, we affirm the ALJ Decision.

Endnotes

¹  Section 1128 of the Act is codified at 42 U.S.C. § 1320a–7.  The current version of the Act can be found at https://www.ssa.gov/OP_Home/ssact/ssact-toc.htm.  Each section of the Act on that website contains a reference to the corresponding United States Code chapter and section.  Cross-reference tables for the Act and the United States Code can be found at https://www.ssa.gov/OP_Home/comp2/G-APP-H.html.

²  As permitted by the Act, the Secretary has delegated to the I.G. the authority to enforce section 1128’s exclusion provisions.  Act § 1128A(j)(2); 48 Fed. Reg. 21,523, 21,662 (May 13, 1983); 53 Fed. Reg. 12,909, 12,993 (Apr. 20, 1988).  The I.G. has issued regulations, codified in 42 C.F.R. Parts 1001 and 1005, implementing the delegated exclusion authority.  See, e.g., 42 C.F.R. §§ 1001.101, 1005.1.

³  Background information is drawn from the ALJ Decision and the record before the ALJ and is not intended to substitute for the ALJ’s findings. 

⁴  The ALJ’s pre-hearing order noted that witness testimony must be submitted in the form of an affidavit or sworn declaration and will only be accepted if relevant to the issues before the ALJ.  Pre-Hearing Order at 3 (¶ 5).  Having determined that Petitioner offered no relevant testimony, the ALJ determined that an in-person hearing was not necessary.  ALJ Decision at 5; see also CRD Procedures at 18-19 (¶¶ 19.b, 19.d) (explaining that when an ALJ orders the parties to submit written direct testimony with their pre-hearing exchange an oral hearing will only be convened for purposes of cross-examination and re-direct).  We find no error in the ALJ’s determination to proceed to a decision without an in-person hearing.  Cf. Nancy L. Clark, DAB No. 2989, at 5-7 (2020).   

⁵  Petitioner argues that the Affidavit was filed in support of the “original felony charges” brought against him that were later “dismissed” pursuant to his plea agreement.  P. Br. at 6 (citing I.G. Ex. 5).  The record, however, contains no evidence that Petitioner was originally charged with a felony, nor does Petitioner’s plea agreement state that any such felony charges were dismissed.  I.G. Exs. 4, 7.  Although the first page of the criminal complaint included a box for “NCIC Extradition Code Type,” in which the code for “Felony Surrounding States” was selected, the only offense charged in the complaint was a violation of 18 Pa. Const. Stat. § 2705, a misdemeanor under Pennsylvania law.  I.G. Ex. 5, at 1-2; see also 18 Pa. Const. Stat. § 2705 (“A person commits a misdemeanor of the second degree if he recklessly engages in conduct which places or may place another person in danger of death or serious bodily injury.”).  Moreover, even if the Affidavit had initially been filed in support of different felony charges, Petitioner acknowledged that the allegations in the Affidavit provided the factual basis for his plea of no contest to the three counts of recklessly endangering another person.  I.G. Ex. 7, at 14.

⁶  Petitioner’s interpretation of section 1128(a)(2) also conflicts “with Congress’s intent that the mandatory exclusion authority be used broadly to protect the integrity of covered programs . . . and our decisions addressing whether an offense is ‘related to’ or occurred ‘in connection with’ the delivery of an item or service.”  Kenneth M. Behr, DAB No. 1997, at 7 (2005).  In the context of section 1128(a)(3) exclusions, the Board has made clear that the phrase “in connection with” requires only a “common sense connection (or nexus) between the offense of which a petitioner was convicted and the delivery of a health care item or service.”  Charice D. Curtis, DAB No. 2430, at 5 (2011) (internal quotations omitted) (rejecting argument that section 1128(a)(3) limits exclusions to offenses involving the actual delivery of healthcare); see also Behr at 8-9 (holding that “an individual’s participation in the chain of delivery of health care items or services” is sufficient to establish the requisite nexus even if the individual’s offense did not involve their “personally delivering an item or service as an element of the offense”).

⁷  We further reject Petitioner’s suggestion that he bore no personal responsibility for the staffing shortages at St. Francis or the resulting consequences.  P. Br. at 11-12 (arguing that “staffing shortages were the norm around the country, through no one’s individual fault” and state surveyors “made no mention of any malfeasance” by Petitioner).  As discussed above, Petitioner is precluded in this proceeding from collaterally attacking the factual basis for his conviction.  See 42 C.F.R. § 1001.2007(d); see also Kallini at 6 n.3.

⁸  “Incarceration means imprisonment or any type of confinement with or without supervised release, including, but not limited to, community confinement, house arrest and home detention.”  42 C.F.R. § 1001.2.

⁹  As the Board has recognized, it is the length of incarceration imposed by the sentence, and not the length of the sentence eventually served, that is relevant to assessing the weight of this aggravating factor.  See Roji Esha, DAB No. 3076, at 30 n.13 (2022). 

¹⁰  Effective February 13, 2017, the mitigating factor under section 1001.102(c)(1) was amended to clarify that it applies only to exclusions imposed under 42 C.F.R. § 1001.101(a) for program-related offenses (i.e., Act § 1128(a)(1)).  See 79 Fed. Reg. 26,810, 26,813 (May 9, 2014) (“First, we propose to clarify that this factor applies only to section 1128(a)(1) of the Act.  This factor does not apply to section 1128(a)(2) of the Act because section 1128(a)(2) pertains to patient abuse and neglect, and financial loss is irrelevant.”).  Petitioner’s exclusion was imposed for offenses related to patient neglect or abuse (i.e., Act § 1128(a)(2); 42 C.F.R. § 1001.101(b)).