Donna Dixon, DAB CR6792 (2025)

DECISION

I affirm the determination of the Centers for Medicare & Medicaid Services (CMS) to deny enrollment of Petitioner, Donna Dixon, in the Medicare program and to add Petitioner’s name to the CMS Preclusion List.

I. Background and Procedural History

On January 31, 2024, CMS received an application from Petitioner to enroll in the Medicare program as a non-physician mental health counselor.  CMS Ex. 3 at 1.  In a February 26, 2024 notice of initial determination, a CMS Medicare contractor denied Petitioner’s application because, on November 19, 2020, the Inspector General (IG) for the Department of Health and Human Services excluded Petitioner from participation in all federal health care programs and, in the preceding ten years, Petitioner was convicted of a felony for “Violations Involving Health Care Payment.”  CMS Ex. 1 at 1. 

On March 2, 2024, Petitioner requested reconsideration of CMS’s actions; however, in an August 14, 2025 reconsidered determination, a CMS hearing officer upheld the initial determination.  Electronic Filing System (E-File) Doc. No. 1a.  

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On August 18, 2025, Petitioner requested a hearing before an administrative law judge (ALJ) to dispute the reconsidered determination.  On August 19, 2025, the Civil Remedies Division acknowledged receipt of the hearing request, provided the parties with the dates for prehearing submissions, and issued my Standing Order. 

On September 23, 2025, CMS filed a prehearing brief (CMS Br.), which included a motion for summary judgment, and four proposed exhibits (CMS Exs. 1-4).  On October 1, 2025, the Civil Remedies Division Director, at my request, issued a notice that I suspended the remaining submission due dates because CMS counsel was furloughed when annual funding for the United States Government expired.  However, on October 2, 2025, I directed Petitioner to submit her prehearing exchange by October 28, 2025, because:  1) CMS had submitted its prehearing exchange already; 2) Petitioner was not affected by the government shutdown; and 3) I must issue a decision in this case within 180 days from the date the appeal was filed (42 C.F.R. § 498.79).  Petitioner did not submit a prehearing exchange. 

II. Admission of Evidence

I admit all of CMS’s proposed exhibits into the record, without objection.  See Standing Order ¶ 10. 

III. Decision on the Written Record

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

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

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

In the present case, all deadlines for prehearing submissions have passed and neither party filed written direct testimony.  Therefore, I issue a decision based on the written

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record.  Anil Hanuman, D.O., DAB No. 3080 at 11-12 (2022); EI Med., Inc., DAB No. 3117 at 15 (2023); Vandalia Park, DAB No. 1940 (2004).

IV. Issues

1. Whether CMS had a legitimate basis to deny Petitioner’s enrollment in the Medicare program under 42 C.F.R. § 424.530(a)(2) and/or (3).
2. Whether CMS had a legitimate basis to include Petitioner on the CMS Preclusion List under 42 C.F.R. §§ 422.2, 422.222, 423.100, and 423.120(c)(6). 

V. Jurisdiction

I have jurisdiction to decide the issues in this case.  42 C.F.R. §§ 498.3(b)(17)(i), (20), 498.5(l)(2), (n)(2); see also 42 U.S.C. § 1395cc(j)(8); 42 C.F.R. §§ 424.545(a), 498.1(g).  

VI. Legal Framework

The Social Security Act (Act) authorizes the Secretary of Health and Human Services (Secretary) to establish regulations governing the enrollment of providers and suppliers in the Medicare program.  42 U.S.C. § 1395cc(j).  Individual healthcare providers seeking enrollment are called “suppliers.”  42 U.S.C. § 1395x(d) (defining “supplier” as a physician, practitioner, facility, or other entity that is not a “provider of services”); see also 42 U.S.C. § 1395x(u) (defining a “provider of services” as a hospital, critical access hospital, rural emergency hospital, skilled nursing facility, comprehensive outpatient rehabilitation facility, home health agency, or hospice program).  

To receive payment for covered Medicare items or services provided to beneficiaries under Medicare Part B, a supplier must enroll in the Medicare program.  42 U.S.C. §§ 1395n(a), 1395u(h)(1); 42 C.F.R. § 424.505.  To enroll, a supplier must meet all enrollment requirements and file an enrollment application.  42 C.F.R. §§ 424.510, 424.530.  If CMS determines that an applicant does not meet the requirements for enrollment, CMS has the authority to deny enrollment.  42 C.F.R. § 424.530. 

CMS may add an individual or entity to the CMS Preclusion List for any of the reasons stated in the regulatory definition of the term “Preclusion list” applicable to Medicare Parts C and D.  42 C.F.R. §§ 422.2, 423.100.  A Medicare Advantage Organization under Medicare Part C may not make payment for a health care item, service, or drug provided by an individual or entity on the Preclusion List.  42 C.F.R. § 422.222(a)(1)(i).  Further, a Medicare Part D sponsor must deny a request for reimbursement from a Medicare beneficiary for a drug prescribed by an individual who is on the Preclusion List.  42 C.F.R. § 423.120(c)(6)(vii)(C).  

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VII. Findings of Fact

1. On June 20, 2019, the Prosecuting Attorney for Jackson County, Missouri, filed an Information in the Circuit Court for Jackson County, Missouri (Circuit Court) charging Petitioner with multiple offenses including Violations Involving Health Care Payments.  CMS Ex. 2 at 3-9.
2. On October 1, 2019, the Prosecuting Attorney filed an Amended Information with the Circuit Court.  CMS Ex. 2 at 2, 10.  Count I charged Petitioner with “Violations Involving Health Care Payments” and alleged as follows:  “[D]efendant, in violation of Section 191.905.1, [Revised Statutes of Missouri], committed the Class C Felony of Making or Causing to be Made a False Statement to Receive a Health Care Payment . . . in that on or about September 21, 2016, . . . defendant was a health care provider and knowingly caused to be made a false representation to the Missouri Department of Social Services, a health care payer, for the purposes of receiving a health care payment, to wit:  that defendant provided individual behavioral health services to A.A., a qualified Medicaid participant, on or about September 13, 2016, which was a false representation of material fact and known by the defendant to be false when made.”  CMS Ex. 2 at 10.
3. On October 3, 2019, Petitioner pleaded guilty to Count I of the Amended Information.  CMS Ex. 2 at 1-2.
4. In an October 3, 2019 Judgment, the Circuit Court “Found [Petitioner] Guilty upon a plea of guilty” of the Class C Felony of violating Section 191.905 of the Revised Statutes of Missouri.  CMS Ex. 2 at 16.
5. The Circuit Court suspended execution of a sentence against Petitioner but placed her on probation for five years, ordered her to pay $3,231.19 in restitution to Missouri Health Net, and ordered her to pay a civil penalty of $5,000.  CMS Ex. 2 at 1, 17-20.
6. On October 30, 2020, the IG excluded Petitioner from participation in all federal health care programs under section 1128(a)(1) of the Act (42 U.S.C. § 1320a-7(a)(1)), for five years based on her conviction in the Circuit Court for a criminal offense related to the delivery of an item or service under the Medicare or a state health care program.  CMS Ex. 4 at 1. 

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VIII. Conclusions of Law and Analysis

1. CMS had a legitimate basis to deny Petitioner’s enrollment as a supplier in the Medicare program because Petitioner was convicted of a felony offense and that offense is per se detrimental to the best interests of the Medicare program and its beneficiaries.  

The Act authorizes the Secretary to “refuse to enter into [a Medicare] agreement with a physician or supplier . . . in the event that such physician or supplier has been convicted of a felony under Federal or State law for an offense which the Secretary determines is detrimental to the best interests of the program or program beneficiaries.”  42 U.S.C. § 1395u(h)(8).  To implement this provision, the Secretary promulgated regulations providing CMS with the authority to deny or revoke the Medicare enrollment of a supplier who was convicted of a felony, in the last ten years, that is detrimental to the best interests of the Medicare program and its beneficiaries.  42 C.F.R. §§ 424.530(a)(3), 424.535(a)(3).1   The Secretary also included a non-exhaustive list of felony offense categories and examples that the Secretary determined were detrimental to the best interests of the Medicare program and its beneficiaries.  42 C.F.R. §§ 424.530(a)(3)(i), 424.535(a)(3)(ii).  Finally, the Secretary cross-referenced the definition of the term “convicted” from the regulations implementing the Secretary’s authority to exclude individuals from federal health care programs (i.e., 42 C.F.R. § 1001.2).  42 C.F.R. §§ 424.530(a)(3), 424.535(a)(3)(i); see also 42 U.S.C. § 1320a-7(i). 

The record shows that Petitioner was convicted of a felony offense within the last ten years and that the offense meets one of the listed categories of offenses that are per se detrimental to the best interests of the Medicare program and its beneficiaries.  As a result, I must uphold the denial of Petitioner’s enrollment in the Medicare program. 

1. Petitioner was convicted of a felony offense within the last ten years. 

The most basic requirement to deny enrollment under 42 C.F.R. § 424.530(a)(3) is that the applicant for enrollment was convicted of a felony offense within the preceding ten years.  Relevant to this case, the word “convicted” means that a “Federal, State or local court has accepted a plea of guilty or nolo contendere by an individual or entity.”  42 C.F.R. § 1001.2; see also 42 U.S.C. § 1320a-7(i)(3).  

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As stated in Finding of Fact 3, Petitioner pleaded guilty to Count I in the Amended Information on October 3, 2019, and, as stated in Findings of Fact 2 and 4, both the Amended Information and the Circuit Court’s Judgment designated the offense in Count I as a felony.  Petitioner concedes that her criminal offense was “legally classified as a felony.”  Hr’g Req. at 2.  Findings of Fact 4 and 5 state that the Circuit Court found Petitioner guilty based on the guilty plea.  Therefore, I conclude that Petitioner was convicted of a felony offense within the preceding ten years. 

b) Petitioner’s felony conviction is per se detrimental to the best interests of the Medicare program and its beneficiaries. 

The Secretary established a non-exhaustive list of the types of felony offenses that CMS treats as per se detrimental to the best interests of the Medicare program and its beneficiaries.  42 C.F.R. § 424.530(a)(3)(i); 71 Fed. Reg. 20,754, 20,768 (Apr. 21, 2006); Letantia Bussell, M.D., DAB No. 2196 at 9 (2008).  The list includes, “[a]ny felonies that would result in mandatory exclusion under section 1128(a) of the Act.”  42 C.F.R. § 424.530(a)(3)(i)(D). 

Under section 1128(a)(1) of the Act, the Secretary must exclude an individual from participation in all federal health care programs if that individual was 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, such as Medicaid.2   42 U.S.C. § 1320a‑7(a)(1).  

In this case, as stated in Findings of Fact 2 and 3, Petitioner pleaded guilty to falsely claiming that she provided services to a Medicaid beneficiary in order to obtain payment from the Missouri Medicaid program.  There is no doubt that such an offense subjects Petitioner to an exclusion under section 1128(a)(1) of the Act.  See Travers v. Shalala, 20 F.3d 993, 998 (9th Cir. 1994) (conviction for filing false claims with the Medicaid program is “a program‑related offense” and “such financial misconduct is exactly what Congress sought to discourage” through imposing exclusions.); Kahn v. Inspector Gen. of the U.S. Dep’t of Health & Hum. Servs., 848 F. Supp. 432, 434, 436 (S.D.N.Y. 1994) (concluding that a podiatrist’s conviction for attempted grand larceny was program-related for purposes of an exclusion because it was related to the filing of false Medicaid claims); Greene v. Sullivan, 731 F. Supp. 835, 838 (E.D. Tenn. 1990) (“There is no question that Mr. Greene’s crime [of filing false claims] resulted in a Medicaid overpayment and was a program-related crime triggering the mandatory exclusion under

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Section 1320a‑7(a).”).  Therefore, I conclude that Petitioner’s felony offense is per se detrimental to the best interests of the Medicare program and its beneficiaries. 

Petitioner disputes CMS’s conclusion that her felony is detrimental to the best interests of the Medicare program and its beneficiaries because her felony “was administrative in nature, non-violent, and arose from incomplete documentation issues rather than fraud against patients or intentional abuse of program funds. . . .  Appellant has since demonstrated substantial rehabilitation, maintained a record of ethical practice, and provided services benefiting vulnerable populations, including victims of domestic violence and individuals in recovery.”  Hr’g Req. at 2. 

Petitioner’s argument does not address the fact that her felony is per se detrimental to the Medicare program.  It is long established that “[t]he categories of offenses set forth under section 424.535(a)(3)(ii) are those that CMS has determined, by rulemaking, to be detrimental to the Medicare program and its beneficiaries as a matter of law.”  Blair Allen Nelson, M.D., DAB No. 3024 at 7 (2020).  Further, “[t]hose categories of per se detrimental offenses include, among other offenses, ‘[a]ny felonies that would result in mandatory exclusion under section 1128(a) of the Act.’”  Nelson, DAB No. 3024 at 8 (quoting 42 C.F.R. § 424.535(a)(3)(ii)(D)).  When CMS concludes that a felony conviction is per se detrimental to the Medicare program and its beneficiaries, CMS may rely on that finding to deny enrollment. 

The regulation provides clear guidance for certain instances where a supplier’s application should be denied.  For example, section 424.530(a)(3) permits CMS to deny enrollment to a supplier if that supplier has been convicted of a felony that is detrimental to the Medicare program.  Under 42 C.F.R. § 424.530(a)(3)(i)(D), a felony which results in mandatory exclusion from the Medicare program under section [1]128 of the Act—such as felony health care fraud—is detrimental to the program.  CMS interpreted the regulation as written and reached a decision entirely consistent with that regulation.  Thus, it was permissible for CMS to deny Plaintiff’s enrollment application based on his health care fraud conviction based only on the language of 42 C.F.R. § 424.530(a)(3).

Tomlinson v. Azar, No. 5:19-CV-05114, 2020 WL 376657 *3 (W.D. Ark. Jan. 23, 2020) (emphasis added). 

My review of this matter is limited to determining if CMS had a legal basis for denying enrollment to Petitioner.  Bussell, DAB No. 2196 at 13 (“[T]he right to review of CMS’s

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determination by an ALJ serves to determine whether CMS had the authority to [deny or] revoke [the supplier’s] Medicare billing privileges, not to substitute the ALJ’s discretion about whether to [deny or] revoke.”).  The CMS hearing officer acknowledged that Petitioner asserted a lack of training and guidance as to the administrative aspects of being a health care provider; however, the CMS hearing officer also stated that “it is of supreme importance to CMS to protect Medicare beneficiaries and the Medicare program from fraud, waste, and abuse” and that Petitioner “has demonstrated a propensity to be untrustworthy and exercise poor judgment in her dealings with a health care program.”  E-File Doc. 1a at 4.  Therefore, CMS exercised independent judgment to determine that Petitioner’s felony conviction was per se detrimental to the best interests of the Medicare program and its beneficiaries and considered Petitioner’s argument for CMS to use its discretion not to deny the enrollment application.  However, once CMS identified that Petitioner’s felony conviction was per se detrimental to the best interests of Medicare and its beneficiaries, CMS was free to deny the enrollment application.  Piano, DAB No. 3096 at 13.  

Petitioner argues that “there was no evidence of harm to patients or financial harm to the Medicare program” from Petitioner’s crime, and that the ALJ’s contrary finding “was plain error.”  Even were we to accept for the moment the bare assertions that Petitioner is no longer “a detriment to patient care and not a financial detriment to the Medicare program” and does not pose a risk of harm to patients or the program, Petitioner could not prevail.  Petitioner’s offense was detrimental per se to Medicare, and therefore facially warranted a denial of Petitioner’s enrollment application, because Petitioner (1) was convicted of a felony offense within 10 years preceding the denial of enrollment; and (2) that conviction was the basis for the I.G.’s exclusion under section 1128(a) of the Act.  Accordingly, the ALJ did not err in concluding that CMS, in its exercise of discretion, lawfully denied enrollment under section 424.530(a)(3). 

Piano, DAB No. 3096 at 13-14. 

Having determined that CMS had a legal basis to conclude that Petitioner’s felony offense is detrimental to the best interests of the Medicare program and its beneficiaries, and that CMS exercised its discretion to deny enrollment, I have no authority to overturn CMS’s decision.  Therefore, I affirm CMS’s denial of enrollment. 

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2. CMS had a legitimate basis to deny Petitioner’s enrollment as a supplier in the Medicare program because the IG excluded Petitioner from participation in all federal health care programs. 

The regulations allow CMS to deny enrollment in the Medicare program if a supplier is “[e]xcluded from the Medicare, Medicaid, and any other Federal health care program . . . in accordance with section 1128 . . . of the Act.”  42 C.F.R. § 424.530(a)(2)(i)(A). 

As stated in Finding of Fact 6, the IG issued a notice on October 30, 2020, informing Petitioner that she was being excluded, under section 1128(a)(1) of the Act, “from participation in any capacity in the Medicare, Medicaid, and all Federal health care programs . . . .”3   IG Ex. 4 at 1 (emphasis omitted).  Although Petitioner acknowledged the exclusion, “she contends that CMS’s automatic reliance on the exclusion as grounds for denial fails to account for mitigating factors, including Appellant’s ongoing compliance with program integrity standards, active rehabilitation efforts, and professional contributions to behavioral health and community recovery services.”  Hr’g Req. at 2. 

I must reject Petitioner’s argument.  As stated above, I only have the authority to determine whether CMS acted legitimately when it denied Petitioner’s enrollment.  CMS was not only acting within its authority to deny enrollment to an excluded individual, but was unable, due to the exclusion, to enroll Petitioner and allow her to participate in the Medicare program.  See Fiaz Afzal, M.D., DAB No. 3097 at 5 (2023); 42 C.F.R. § 424.530; E-File Doc. No. 1a at 3. 

3. CMS had a legitimate basis to include Petitioner on the Preclusion List. 

Based on Petitioner’s felony conviction and exclusion, CMS also placed Petitioner’s name on the CMS Preclusion List. 

CMS may add an individual to the Preclusion List when the individual has been convicted of a felony under federal or state law within the previous ten years and CMS determines that the felony is detrimental to the best interests of the Medicare program.  To determine whether to add an individual’s name to the Preclusion List, CMS must consider the following factors:  i) the severity of the offense; ii) when the offense occurred; and iii) any other information that CMS deems relevant to its determination. 

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42 C.F.R. §§ 422.2 (paragraph (3) of definition of “Preclusion list”), 423.100 (paragraph (3) of definition of “Preclusion list”).  

In the reconsidered determination, the CMS hearing officer provided the following analysis of the relevant factors: 

Regarding factor (i), [Petitioner’s] offense is very severe.  As stated above, [Petitioner] was convicted of Violations Involving Health Care Payment in violation of Revised Statutes of Missouri § 191.905.  [Petitioner] knowingly made a false representation, on September 21, 2016, for the purposes of receiving a health care payment for providing individual behavioral health services to A.A. on or about September 13, 20[]16.  [Petitioner] knew she did not provide services to A.A. on that day and time.  CMS finds that Ms. Dixon’s offense was extremely severe, and the severity of the offense is further demonstrated by the Court sentencing her to five years’ probation and ordering her to pay $3,231.19 in restitution and a Civil penalty of $5,000.  The severity of the offense is also demonstrated by the fact that it resulted in her mandatory exclusion by the OIG.  

Regarding factor (ii), [Petitioner’s] felony occurred on September 21, 2016.  [Petitioner] was convicted on October 3, 2019.  This conduct occurred several years ago, but this factor alone is not dispositive.  

Regarding factor (iii), CMS finds relevant that a determination of detriment to the best interests of the Medicare program is inherent in our implementation of the denial of [Petitioner’s] Medicare enrollment under § 424.530(a)(3), which was upheld after reconsideration above. [Petitioner’s] offense is detrimental to the best interests of the Medicare program because she lacks integrity and has made poor judgments.  CMS is committed to maintaining quality service to beneficiaries enrolled in the Medicare program. Medicare is a program for the public and public confidence in the program is vital to its success.  [Petitioner’s] behavior jeopardizes confidence in Medicare partners is necessarily detrimental to the best interests of the Medicare program. Therefore, with consideration to the factors discussed above, CMS finds that [Petitioner’s] felony

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offense is detrimental to the best interests of the Medicare program and forms an appropriate basis to include her on the CMS Preclusion List. As a result, CMS upholds [Petitioner’s] placement on the CMS Preclusion List, effective the date of this decision. 

E-File Doc. No. 1a at 6 (internal citations omitted). 

CMS may also add an individual to the Preclusion List when the individual has engaged in behavior (other than under 42 C.F.R. § 424.535(a)(3)) for which CMS could have revoked the individual’s enrollment in the Medicare program and CMS determines that the underlying conduct that could have been the basis for revocation is detrimental to the best interests of the Medicare program.  To determine whether to add an individual’s name to the Preclusion List, CMS must consider the following factors:  A) the seriousness of the conduct involved; B) the degree to which the individual’s conduct could affect the integrity of the Medicare program; and C) any other information that CMS deems relevant to its determination.  42 C.F.R. §§ 422.2 (paragraph (2) of definition of “Preclusion list”), 423.100 (paragraph (2) of definition of “Preclusion list”).  

In the reconsidered determination, the CMS hearing officer provided the following analysis of the relevant factors: 

Regarding factor (A), the conduct that led to the denial of [Petitioner’s] Medicare enrollment under § 424.530(a)(2) is her OIG exclusion.  The conduct that led to the OIG exclusion was her conviction of Violations Involving Health Care Payment.  Based on the information, [Petitioner] did knowingly cause to be made a false representation to the Missouri Department of Social Services for the purposes of receiving a health care payment.  [Petitioner’s] actions displayed a disregard for the law, and her actions call into question her judgment and trustworthiness.  CMS finds this conduct to be extremely serious.  

Regarding factor (B), [Petitioner’s] active OIG exclusion poses a severe and immediate risk to the Medicare program as she is currently ineligible to participate in the program.  [Petitioner’s] OIG exclusion, cause of her OIG exclusion, and felony conviction presented a significant program integrity risk.  The integrity of the Medicare program is dependent upon the integrity and reliability of our partners.  As a result,

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CMS finds that [Petitioner’s] conduct negatively affected the integrity of the Medicare program.  

Regarding factor (C), CMS finds relevant that the conduct that ultimately led to [Petitioner’s] OIG exclusion reflects poorly on the medical profession as a whole and jeopardizes public confidence in Medicare providers and suppliers.  CMS is committed to maintaining quality service to beneficiaries enrolled in the Medicare program, and that includes the quality of care provided by its partners.  Medicare is a program for the public and public confidence is vital to its success.  [Petitioner’s] improper and unprofessional conduct in her medical practice could significantly impact the public’s confidence in the Medicare program and its partners.  Any threat to public confidence in the Medicare program is necessarily detrimental to the best interests of the program. After reviewing the regulatory factors, CMS finds that the conduct that would have led to the revocation [of] [Petitioner’s] Medicare enrollment had she been enrolled is detrimental to the best interests of the Medicare program[.] 

E-File Doc. No. 1a at 5 (internal citations omitted). 

Petitioner disputes the addition of her name to the Preclusion List, arguing that CMS failed to adequately weigh Petitioner’s professional rehabilitation, low risk of re-offense, and ongoing service to the community.  Hr’g Req. at 2. 

My review of the record indicates that the CMS hearing officer articulated satisfactory concerns relevant to the factors that needed to be considered.  Further, Petitioner’s argument is vague and not supported by evidence in the record.  Finally, Petitioner’s exclusion prohibits CMS from allowing Petitioner to participate in Medicare Parts C and D.  Therefore, I uphold CMS’s determination that Petitioner’s felony offense and exclusion from participation in federal health care programs is detrimental to the Medicare program and, consequently, uphold the addition of Petitioner’s name to the Preclusion List.  See Omair Chaudry, M.D., DAB No. 3145 at 18 (2024) (“Moreover, having determined that Petitioner’s felony offense is detrimental to the Medicare program for purposes of revocation, we can discern no legal basis that would compel CMS to find the offense not detrimental to the Medicare program for purposes of the preclusion list.”). 

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IX. Conclusion

I affirm CMS’s denial of Petitioner’s application to enroll in the Medicare program and uphold CMS’s determination to place Petitioner’s name on the CMS Preclusion List.