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                              Marci Bradford, DAB CR5679 (2020)
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Marci Bradford, DAB CR5679 (2020)








  
  
    

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





Marci Bradford
	(NPI: 1306070297 / PTANS: K400326793, K400382799, K400424989, K400301841),
	Petitioner,
v.
Center for Medicare & Medicaid Services.
Docket No. C-20-276Decision No. CR5679August 6, 2020

        
              
    

      DECISION
In an initial determination, the Centers for Medicare & Medicaid Services (CMS), through a CMS contractor, revoked the Medicare enrollment and billing privileges of Marci Bradford (Petitioner) based on Ms. Bradford’s felony conviction for injury by intoxicated use of a vehicle, failure to disclose the felony conviction, and failure to report the felony conviction to CMS within 30 days of its occurrence.  The CMS contractor also barred Ms. Bradford from re-enrolling in the Medicare program for three years, effective 30 days from the date of the initial determination, and added her to the CMS preclusion list, effective March 1, 2020.  Petitioner requested reconsideration, but a CMS hearing officer upheld the initial determination.  Petitioner sought further review and requested a hearing before an administrative law judge (ALJ).  For the reasons stated below, I affirm CMS’s determination.
I.  Background and Procedural History
Ms. Bradford is a nurse practitioner in Wisconsin who was enrolled as a supplier in the Medicare program.  CMS Ex. 5 at 4, 7; CMS Ex. 6 at 6, 9.  In a September 16, 2019 initial determination, a CMS contractor revoked Ms. Bradford’s Medicare enrollment and billing privileges, effective June 17, 2014, for the following reasons:
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**42 CFR § 424.535(a)(3) – Felonies**
[CMS] has been made aware of your June 17, 2014, felony conviction, as defined in 42 C.F.R. § 1001.2, for Injury by Intoxicated Use of a Vehicle, in violation of Wisconsin Statutes § 940.25(1)(a) in the State of Wisconsin, Circuit Court Branch 1, Winnebago County.
**42 CFR § 424.535(a)(4) - False or Misleading Information**
On your [CMS] 855I enrollment applications, signed on September 10, 2016, May 24, 2017, and October 10, 2017, you answered “no” in section three of the application, indicating that you did not have any adverse legal history.  However, you were convicted of Injury by Intoxicated Use of a Vehicle, in violation of Wisconsin Statutes § 940.25(1)(a) in the State of Wisconsin, Circuit Court Branch 1, Winnebago County on June 17, 2014.  A felony conviction is listed as an adverse legal action that requires reporting on the 855I application.
**42 CFR § 424.535(a)(9) - Failure to Report**
[CMS] has been made aware of your June 17, 2014, felony conviction, as defined in 42 C.F.R. § 1001.2, for Injury by Intoxicated Use of a Vehicle, in violation of Wisconsin Statutes § 940.25(1)(a) in the State of Wisconsin, Circuit Court Branch 1, Winnebago County.  You did not notify CMS of this adverse legal action as required under 42 CFR § 424.516.
CMS Ex. 3 at 1-2 (emphasis in original).  The CMS contractor also barred Ms. Bradford from re-enrolling in the Medicare program for three years, effective 30 days from the date of the initial determination.  CMS Ex. 3 at 3.  Finally, the CMS contractor said it would add Petitioner to CMS’s preclusion list effective March 1, 2020.  CMS Ex. 3 at 2.
On October 1, 2019, Ms. Bradford timely requested reconsideration.  CMS Ex. 2.  Ms. Bradford did not dispute her 2014 felony conviction for injury by intoxicated use of a vehicle.  However, Petitioner argued there was no basis for revocation under 42 C.F.R. § 424.535(a)(4) and (9), because her “felony conviction had no effect on [her] ability to care for patients, nor was [her] license suspended or revoked at any point in time.”  CMS Ex. 2 at 2.  Additionally, Petitioner noted that the crime for which she was convicted was not among the crimes that CMS determined to be detrimental to the best interests of the
Page 3
Medicare program and its beneficiaries.  CMS Ex. 2 at 2.  Petitioner further indicated that, while the older CMS-855I applications were ambiguous as to the meaning of a felony conviction, “[t]he newly revised application does not leave ambiguity as to whether or not a specific felony conviction would need or need not be reported.”  CMS Ex. 2 at 3.  Petitioner did not expressly dispute her inclusion on the preclusion list.
A CMS hearing officer issued a December 5, 2019 reconsidered determination upholding the revocation.  CMS Ex. 1.  The hearing officer found that:
[Petitioner’s] felony conviction for injury by intoxicated use of a vehicle in violation of Wisconsin Statute § 940.25(1)(a) to be detrimental to the best interests of the Medicare program and its beneficiaries.  Additionally, Ms. Bradford failed to disclose the felony conviction on three separate Medicare applications.  She also failed to timely report her felony conviction to CMS within 30 days of its occurrence.  Therefore, CMS upholds the revocation of Ms. Bradford’s Medicare billing privileges under 42 C.F.R. § 424.535(a)(3), (4), and (9).
CMS Ex. 1 at 6.  Additionally, the CMS hearing officer upheld Petitioner’s “inclusion on the CMS Preclusion List because her Medicare billing privileges are revoked, her Medicare enrollment is currently under a reenrollment bar, and CMS finds that the conduct underlying the revocation of [Petitioner’s] Medicare billing privileges pursuant to § 424.535(a)(3), (4), and (9) is detrimental to the best interests of the Medicare program.”  CMS Ex. 1 at 6-7.
On February 2, 2020, Petitioner timely requested a hearing.  On February 5, 2020, the Civil Remedies Division (CRD) issued an acknowledgment of Petitioner’s hearing request and my Standing Prehearing Order.  On March 11, 2020, CMS filed its prehearing exchange that included one proposed exhibit.  Because CMS’s proposed exhibit was comprised of numerous documents, I rejected CMS’s proposed exhibit, and gave CMS an opportunity to resubmit its proposed exhibits in conformance with the Standing Prehearing Order.  On March 24, 2020, CMS filed a revised prehearing exchange, which included ten proposed exhibits (CMS Exs. 1-10).  Petitioner submitted a response (P. Br.) without exhibits.  CMS waived its right to reply.
II.  Decision on the Record
Petitioner did not object to any of CMS’s proposed exhibits; therefore, I admit CMS Exs. 1-10 into the record.  *See* Standing Prehearing Order ¶ 10; CRD Procedures § 14(e).  My Standing Prehearing Order advised the parties that an in-person hearing would only be necessary if a party submitted the written direct testimony of a proposed witness and
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the opposing party requested an opportunity to cross-examine a witness.  Standing Prehearing Order ¶¶ 11-13; CRD Procedures §§ 16(b), 19(b); *see* *Vandalia Park*, DAB No. 1940 (2004); *Pac. Regency Arvin*, DAB No. 1823 at 8 (2002) (holding that the use of written direct testimony for witnesses is permissible so long as the opposing party has the opportunity to cross-examine those witnesses).  Neither party offered written direct testimony.  Therefore, there is no need for an in-person hearing, and I decide this case based on the written record.  Standing Prehearing Order ¶ 14; CRD Procedures § 19(d).
III.  Issues
Whether CMS had a legitimate basis for revoking Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(3), (4), and (9).1
	Whether CMS had a legitimate basis for placing Petitioner on the preclusion list.  42 C.F.R. §§ 422.2, 422.222, and 423.100.IV.  Jurisdiction
I have jurisdiction to decide this case.  42 C.F.R. §§ 498.1(g), 498.3(b)(17), 498.5(*l*)(2);*see also* 42 U.S.C. § 1395cc(j)(8).
V.  Findings of Fact, Conclusions of Law, and Analysis
My findings of fact and conclusions of law are set forth in italics and bold font.
The Social Security Act (Act) authorizes the Secretary of Health and Human Services (Secretary) to establish regulations governing the enrollment of suppliers in the Medicare program.  42 U.S.C. § 1395cc(j).  Petitioner is a nurse practitioner and, therefore, a “practitioner” and a “supplier” for Medicare program purposes.  *See* 42 U.S.C. §§ 1395u(b)(18)(C)(i), 1395x(d), (s)(2)(H)(i), (s)(2)(K)(ii), (aa)(5)(A).
The Secretary delegated to CMS the authority to revoke a supplier’s Medicare enrollment and billing privileges.  42 C.F.R. § 424.535(a).  When CMS imposes revocation, CMS establishes a re-enrollment bar that lasts from one to three years.  42 C.F.R. § 424.535(c).  Generally, a revocation becomes effective 30 days after CMS mails the initial determination revoking Medicare billing privileges.  42 C.F.R. § 424.535(g).
Page 5
***1. On June 17, 2014, Petitioner pleaded no contest to one count of******Injury by Intoxicated Use of a Vehicle, a Class F Felony under Wisconsin******state law, and, on that same date, was convicted of that crime by the Circuit Court for Winnebago County, Wisconsin (Circuit Court).***
On October 1, 2013, charges involving six felony counts were filed against Petitioner in the Circuit Court.  CMS Ex. 4 at 3, 7.  On June 17, 2014, Petitioner pleaded no contest to one count of injury by intoxicated use of a vehicle, a Class F Felony, in violation of Wis. Stat. Ann. § 940.25(1)(a).  CMS Ex. 4 at 3-4, 10.  On that same date, the Circuit Court dismissed the five other felony counts, but found Petitioner guilty of the felony count for which she pleaded no contest.  CMS Ex. 4 at 3-4, 14.
***2. Although Petitioner informed the Nursing Board of the Wisconsin Department of Safety and Professional Services (Nursing Board) and a prospective employer that she had been convicted of a felony involving the injury of others, Petitioner never informed CMS or a CMS contractor of the conviction.***
On June 24, 2014, Petitioner self-reported her conviction for injury by intoxicated use of a vehicle to the Nursing Board.  By letter dated December 3, 2014, the Nursing Board stated “[t]he information provided was screened and opened for investigation” and after reviewing the case, the Nursing Board voted to close the case and determined there was no violation.  CMS Ex. 8 at 1.
In June 2016, Ministry Health Care received an employment application from Petitioner.  CMS Ex. 9.  The Disciplinary Actions/Investigations section asked “[h]ave you ever been convicted of a felony, including a Medicare-or Medicaid related crime, or are criminal charges currently pending against you?”  CMS Ex. 9 at 3.  Petitioner checked the box indicating “Yes,” and provided an explanation.  CMS Ex. 9 at 3-4.
On September 20, 2017, Petitioner signed a State of Wisconsin Background Information Disclosure form.  CMS Ex. 10 at 3.  Section A, entitled Acts, Crimes, and Offenses, asked “[d]o you have *any*criminal charges pending against you or were you ever convicted of any crime anywhere, including in federal, state, local, military, and tribal courts?”  CMS Ex. 10 at 1.  Petitioner checked the box indicating “Yes,” and noted, “9/2013 Felony-intoxicated use of a motor vehicle causing great bodily injury . . . .”  CMS Ex. 10 at 1.
Subsequent to the conviction, Petitioner filed CMS-855I enrollment applications for the purpose of updating information and revalidating enrollment.  CMS Ex. 5 at 1-2; CMS Ex. 6 at 4.  On September 10, 2016, May 24, 2017, and October 10, 2017, Petitioner signed CMS Form-855I enrollment application certification statements.  CMS Ex. 5 at 25; CMS Ex. 6 at 27; CMS Ex. 7 at 4.  Section 3 of the CMS-855I, entitled Final Adverse
Page 6
Legal Action History, asked, “[h]ave you, under any current or former name or business identity, ever had a final adverse legal action listed on page 12 of this application imposed against you?”  CMS Ex. 5 at 12; CMS Ex. 6 at 14; CMS Ex. 7 at 2.  Page 12 of the form discussed Final Adverse Legal Actions and specified these included convictions of felony crimes against persons.  CMS Ex. 5 at 11; CMS Ex. 6 at 12; CMS Ex. 7 at 1.  On all three Form-855I enrollment applications, the box for “No” was checked off.  CMS Ex. 5 at 12; CMS Ex. 6 at 14; CMS Ex. 7 at 2.  Petitioner does not dispute that she did not inform CMS or a CMS contractor of her felony conviction involving the injury to others.  P. Br. at 1.
***3. CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment and billing privileges based on Petitioner’s felony conviction, within ten years of the revocation, for injury by intoxicated use of a vehicle, which is a felony that is detrimental per se to the best interests of the Medicare program and its beneficiaries under 42 C.F.R. § 424.535(a)(3) because it is a crime against persons.***
The Act authorizes the Secretary to discontinue the enrollment of a physician or other supplier who “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 [Medicare] program or program beneficiaries.”  42 U.S.C. § 1395u(h)(8).  The Secretary used this authority to promulgate a regulation permitting CMS to revoke a supplier’s Medicare enrollment and billing privileges if the “supplier was, within the preceding 10 years, convicted (as that term is defined in 42 [C.F.R. §] 1001.2) of a Federal or State felony offense that CMS determines is detrimental to the best interests of the Medicare program and its beneficiaries.”2
  42 C.F.R. § 424.535(a)(3)(i).  Further, the Secretary provided in the regulations a non-exhaustive list of the types of felony offenses that CMS will treat as per se detrimental to the best interests of the program and its beneficiaries.  42 C.F.R. § 424.535(a)(3)(ii); 71 Fed. Reg. 20,754, 20,768 (Apr. 21, 2006); *Letantia Bussell, M.D.*,DAB No. 2196 at 9 (2008).  That list includes “[f]elony crimes against persons, such as murder, rape, assault, and other similar crimes for which the individual was convicted, including guilty pleas and adjudicated pretrial diversions.”  42 C.F.R. § 424.535(a)(3)(ii)(A).
The record establishes that, for revocation purposes, Petitioner was convicted of a felony on June 17, 2014, when she pleaded no-contest to one count of injury by intoxicated use of a vehicle, a Class F Felony in violation of Wis. Stat. Ann. § 940.25(1)(a), and that, based on the plea, the Circuit Court found her guilty/convicted her of that crime.  CMS Ex. 4 at 3-4, 14; 42 C.F.R. §§ 424.535(a)(3)(i), 1001.2 (defining “convicted”); *Norman*
Page 7
*Johnson, M.D*., DAB No. 2779 at 20 (applying the definition of “convicted” in 42 C.F.R. § 1001.2 to a revocation based on a 2008 no-contest plea).
The regulation at 42 C.F.R. § 424.535(a)(3)(ii)(A) expressly deems a felony conviction for crimes against persons as per se detrimental to the best interests of the Medicare program and its beneficiaries.  *See Bussell*,DAB No. 2196 at 9.  The Wisconsin statute that Petitioner violated defines injury by intoxicated use of a vehicle as “[c]ausing great bodily harm to another human being by the operation of a vehicle while under the influence of an intoxicant.”  Wis. Stat. Ann. § 940.25(1)(a).  Therefore, Petitioner’s conviction fits the per se category of a crime against a person.
Further, Petitioner provided details of her crime that show it involved a crime against persons.  In a June 2016 job application, Petitioner responded to the question, “[h]ave you ever been convicted of a felony[,]” by describing the incident which led to her felony conviction.  CMS Ex. 9 at 3-4.  Specifically, Petitioner noted that her intoxicated use of a motor vehicle resulted in injury to others, including a neck fracture and head trauma.  Petitioner further admitted that a “broken bone” “constitutes ‘great bodily Injury [sic]’” and resulted in her felony conviction.  CMS Ex. 9 at 4; *See*P. Br. at 1.
Petitioner argues in opposition that, “the definition surrounding felony convictions was quite unclear and left room for misinterpretation.”  P. Br. at 1.  Petitioner indicated that she believed the felony crimes referenced in CMS Form-855I were felonies “that placed the Medicare program or its beneficiaries at immediate risk . . . .”  P. Br. at 1.
The regulation provides a list of felony offenses against persons (i.e., murder, rape, assault) so that there can be some additional clarity as to the offenses that are covered.  That list, however, does not narrow the category of crimes against persons because that category includes “other similar crimes.”  42 C.F.R. § 424.535(a)(3)(ii)(A).  The phrase “other similar crimes” is not to be interpreted narrowly.  *Ahmed v. Sebelius*, 710 F. Supp. 2d. 167, 174 (D. Mass. 2010).  Felony disorderly conduct involving the reckless handling, displaying, or discharging of a deadly weapon was considered sufficiently similar to assault to qualify as a per se detrimental crime against a person.  *Sunsites Pearce Fire District*, DAB No. 2926 at 11-12 (2018) *rev’d on other grounds, Sunsites-Pearce Fire District* *v. Azar*, No. CV-19-00203 (D. Ariz. July 13, 2020).  Therefore, Petitioner’s felony that included great bodily injury to another is also sufficiently analogous to assault.
Accordingly, I conclude that CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(3).
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***4. There is a legitimate basis for CMS to revoke Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(9), because Petitioner’s felony conviction in the Circuit Court constituted an adverse legal action, and Petitioner did not report that adverse legal action to CMS within 30 days as required by 42 C.F.R. § 424.516(d)(1).***
The regulation at 42 C.F.R. § 424.535(a)(9) provides that CMS may revoke a supplier’s Medicare billing privileges for failure to comply with the reporting requirements specified in 42 C.F.R. § 424.516(d)(1).  That regulation requires physicians, nonphysician practitioners, and physician and nonphysician practitioner organizations to report, within 30 days, any adverse legal action to their Medicare contractor.  42 C.F.R. § 424.516(d)(1).  Failure to timely report is a basis to revoke a supplier’s Medicare enrollment and billing privileges.  42 C.F.R. § 424.535(a)(9).
The regulations define a “final adverse action” to include “[a] conviction of a Federal or State felony offense (as defined in § 424.535(a)(3)(i)) within the last 10 years preceding enrollment, revalidation, or re-enrollment.”  42 C.F.R. § 424.502.  As explained above, Petitioner’s felony conviction on June 17, 2014, satisfies this definition and, as a result, was a reportable adverse legal action.  Thus, Petitioner was required to report her felony conviction to the CMS contractor by July 17, 2014, which was 30 days from her June 17, 2014 conviction.
In response, Petitioner states, “I do not dispute that I have been convicted of a felony within the last 10 years.  That is undeniable.”  P. Br. at 1.  Additionally, Petitioner does not assert that she reported her felony conviction to CMS within 30 days of the conviction, as required by 42 C.F.R. § 424.516(d)(1).  Instead, Petitioner argues that she was unaware of the requirement to self-report her felony conviction to CMS, and relied on the “expertise of Credentialing Department Specialists to provide accurate and complete information when forwarding credentialing applications, insurance forms and other documents that required my signature.”  Hearing Req. at 1; P. Br. at 2.  Petitioner further asserts that she was never advised “by an employer, nor by an employer’s Credentialing Department that I was required to report the felony conviction directly and separately to CMS.”  Hearing Req. at 1; P. Br. at 2.  Petitioner notes that she did self-report her felony conviction to the Nursing Board, and on all prospective employment applications, and never “intentionally withheld this information from any employer, on any background check or from the State Licensing Board and all in the appropriate time and manner.”  P. Br. at 2; CMS Exs. 8-10.
Petitioner’s argument is unavailing.  When Petitioner originally enrolled in the Medicare program, Petitioner had to sign a CMS Form-855I document and certify that “I agree to notify the Medicare contractor of a change in ownership, practice location and/or Final Adverse Action within 30 days of the reportable event.”  *See* CMS Ex. 5 at 24.  Further, the regulations plainly define a final adverse action and, as explained above, her felony
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offense that involved “great bodily harm” to another is obviously a felony crime against persons under that definition.  42 C.F.R §§ 424.502, 424.535.  Furthermore, each of the three CMS Form-855I enrollment applications point to “final adverse legal action[s] listed on page 12 . . . .”  CMS Ex. 5 at 12.  Page 12 also indicates convictions are final adverse actions and notes, “[f]elony crimes against persons and other similar crimes for which the individual was convicted, including guilty pleas and adjudicated pre-trial diversions . . . .”  CMS Ex. 5 at 11.  As to Petitioner’s argument that the failure to timely report the felony conviction to the CMS contractor is the fault of employees in the Credentialing Department of her former employer, I note that the Departmental Appeals Board generally does not accept such an excuse as sufficient to reverse a revocation.  *See generally Mark Koch*, *D.O.*, DAB No. 2610 at 4-5 (2014) (false statement on an enrollment application); *Louis J. Gaefke, D.P.M.*, DAB No. 2554 at 6 (2013) (inaccurate information on Medicare billing).
Therefore, I reject Petitioner’s arguments and conclude that Petitioner’s felony conviction for injury by intoxicated use of a vehicle was a reportable adverse legal action under 42 C.F.R. § 424.516(d)(1).  Therefore, CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(9).
***5. CMS properly set the effective date for revocation as******June 17, 2014******, because Petitioner was convicted on that date.***
The regulation at 42 C.F.R. § 424.535(g) states that when a revocation is based on a felony conviction, the revocation of the supplier’s billing privileges is effective as of the date of the felony conviction, which occurred on June 17, 2014.  CMS Ex. 4 at 3-4, 14.  The purpose of imposing a retroactive effective date was to give suppliers an incentive to report their felony convictions in a timely manner.  73 Fed. Reg. 69,725, 69,777 (Nov. 19, 2008).  In this case, Petitioner did not report her felony conviction.  Therefore, CMS properly set the effective date for revocation as June 17, 2014.
***6. I do not have the authority to review the length of the re-enrollment bar.***
Whenever CMS has properly imposed revocation on a supplier, CMS must also determine how long the supplier will be barred from seeking re-enrollment as a supplier.  The regulations at 42 C.F.R. § 424.535(c)(1) provide that the re-enrollment bar “[b]egins 30 days after CMS or its contractor mails notice of the revocation and lasts a minimum of 1 year, but not greater than 3 years . . . depending on the severity of the basis for revocation.”
In this case, the CMS contractor imposed a three-year re-enrollment bar on Petitioner, beginning October 16, 2019.  CMS Ex. 1 at 5.  Petitioner has not asserted that the three-year re-enrollment bar is excessive.  In any event, the length of the re-enrollment bar CMS imposes is not a determination subject to review by an ALJ.  *Vijendra Dave, M.D.*,
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DAB No. 2672 at 9 (2016) (“our authority in a revocation case does not extend to reviewing the length of the reenrollment bar imposed by CMS.”).
Finally, to the extent that any of Petitioner’s arguments may be construed as a request for equitable relief, I have no authority to provide her with any form of equitable relief.  *See* *US Ultrasound*, DAB No. 2302 at 8 (2010).  I am also required to follow the Act and regulations and have no authority to declare statutes or regulations invalid.  *1866ICPayday.com, L.L.C.*, DAB No. 2289 at 14 (2009).
***7. CMS had a legitimate basis to add Petitioner to the CMS preclusion list, effective March 1, 2020.***
On July 22, 2016, the Comprehensive Addiction and Recovery Act of 2016 (CARA) was enacted, and its stated purpose was to “authorize the Attorney General and Secretary of Health and Human Services to award grants to address the prescription opioid abuse and heroin use crisis, and for other purposes.”  Pub. L. No. 114-198, 130 Stat. 695 (2016).  Section 704 of the CARA called on the Secretary to establish a program to prevent prescription drug abuse under Medicare Parts C and D.  130 Stat. 695 at 742-52.  Among other things, Section 704 amended the Act (42 U.S.C. § 1395w-10(c)) to require the Secretary to implement a drug management program to limit access to controlled substances for at-risk Medicare beneficiaries.  130 Stat. 695 at 742-48.  Section 704(g) of the CARA directed the Secretary to promulgate regulations implementing the provisions of that section of the act.  130 Stat. 695 at 751-52.  Section 704(g)(1) directed that “amendments made by this section shall apply to prescription drug plans . . . for plan years beginning on or after January 1, 2019.”  130 Stat. 695 at 751.  Additionally, Section 704(b)(2) of the CARA specifically amended the Act, at 42 U.S.C. § 1395w-104(c), to add a provision for a “utilization management tool to prevent drug abuse,” and required that the Secretary conduct a “[r]etrospective utilization review to identify . . . providers of services or suppliers that may facilitate the abuse or diversion of frequently abused drugs by beneficiaries.”  130 Stat. 695 at 748.
The Secretary issued a notice of proposed rulemaking to implement the CARA on November 28, 2017.  82 Fed. Reg. 56,336 (Nov. 28, 2017).  As relevant here, the Secretary proposed that a Medicare Advantage (MA) organization may not make payment for an item or service that is furnished by an individual or entity on a newly established preclusion list, and likewise, that a Part D plan sponsor must reject pharmacy claims for Part D drugs if the prescriber is on the same preclusion list.  82 Fed. Reg. at 56,340.  The Secretary explained that individuals, entities, and prescribers would be placed on the preclusion list if certain requirements were all met, to include having engaged in conduct that is detrimental to the best interests of the Medicare program and its beneficiaries.  82 Fed. Reg. at 56,340.  The Secretary “note[d] also that [his] proposal is of particular importance when considering the current nationwide opioid crisis” and that “the inclusion of problematic prescribers on the preclusion list could reduce the
Page 11
amount of opioids that are improperly or unnecessarily prescribed by persons who pose a heightened risk to the Part D program and Medicare beneficiaries.”  82 Fed. Reg. at 56,444.  With respect to the Part C program, the Secretary remarked that “we believe that an appropriate balance can be achieved between this program integrity objective and the desire to reduce the burden on the provider and supplier communities” and “propose[d] to utilize the same ‘preclusion list’ concept in MA that we are proposing for Part D.”  82 Fed. Reg. at56,448.  The Secretary further remarked that “[w]e believe this approach would allow us to concentrate our efforts on preventing MA payment for items and services furnished by providers and suppliers that could pose an elevated risk to Medicare beneficiaries and the Trust Funds, an approach, as previously mentioned, similar to the risk-based process in § 424.518.”  82 Fed. Reg. at56,448.  In his final rule, the Secretary established a January 1, 2019 effective date for the preclusion list, which is consistent with the CARA’s mandate.  83 Fed. Reg. 16,440 (Apr. 16, 2018).
The regulation established a single list of individuals and entities for whom MA plans cannot provide reimbursement for items and services they provide, and for prescribers to whom Medicare Part D plans cannot provide reimbursement for any prescriptions the individuals write.  42 C.F.R. §§ 422.222, 423.120(c)(6).
As applicable to this case, in order for CMS to include an individual, entity, or prescriber on its preclusion list, all of the following three requirements must be met:
(i)   The [individual, entity, or prescriber] is currently revoked from Medicare under [42 C.F.R.] § 424.535.
(ii)   The [individual, entity, or prescriber] is currently under a reenrollment bar under [42 C.F.R] § 424.535(c).
(iii)   CMS determines that the underlying conduct that led to the revocation is detrimental to the best interests of the Medicare program.  In making this determination under this paragraph . . . , CMS considers the following factors:
A.  The seriousness of the conduct underlying the . . . revocation.
B.  The degree to which the . . . conduct could affect the integrity of the Medicare [Part D] program.
Page 12
C.  Any other evidence that CMS deems relevant to its determination.
42 C.F.R. §§ 422.2, 423.100.
CMS added Petitioner to its preclusion list because Petitioner’s Medicare billing privileges were revoked, she was under a three year re‐enrollment bar, and CMS determined that the underlying conduct that led to her revocation was detrimental to the best interests of the Medicare program.  CMS Ex. 1 at 5.
In its reconsidered determination, the CMS hearing officer reasoned that Petitioner’s underlying conduct that led to the revocation was serious in nature, “involved a willful disregard for public safety” by irresponsibly causing bodily injury to another, and demonstrated poor judgment by operating a vehicle while under the influence.  CMS Ex. 1 at 6.
Petitioner does not expressly dispute her inclusion on the preclusion list in either her hearing request or her brief.  Hearing Req.; P. Br.
Petitioner’s felony conviction is per se detrimental to the best interests of the Medicare program and its beneficiaries; therefore, the underlying conduct that resulted in her revocation was detrimental to the best interests of the Medicare program.  Petitioner’s Medicare billing privileges were revoked effective June 17, 2014, and she is currently under a re-enrollment bar.  I have upheld that revocation in this decision.  Therefore, I uphold CMS’s decision to include Petitioner on the preclusion list effective March 1, 2020.
VI.  Conclusion
I affirm CMS’s determination to revoke Petitioner’s Medicare enrollment and billing privileges, effective June 17, 2014.  I also affirm CMS’s determination to include Petitioner on the preclusion list, effective March 1, 2020.


          /s/
        Scott Anderson

                      Administrative Law Judge
      1. Because, as discussed below, I uphold 42 C.F.R. § 424.535(a)(3) and (9) as legitimate bases for revocation, it is unnecessary for me to discuss whether 42 C.F.R. § 424.535(a)(4) also could serve as a basis for revocation. back to note 1
                      2. The Departmental Appeals Board applies the regulations in effect at the time of the revocation.  John P. McDonough III, Ph. D., et al., DAB No. 2728 at 2 n.1 (2016). back to note 2 Back to top
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