Mark R. LaFlamme, MD, CR6411 (2023)

DECISION

The Centers for Medicare & Medicaid Services (CMS) upheld a determination by First Coast Services Options (First Coast), a Medicare administrative contractor, revoking the Medicare enrollment and billing privileges of Petitioner, Mark R. LaFlamme, MD, pursuant to 42 C.F.R. § 424.535(a)(13) based on the Drug Enforcement Administration’s (DEA’s) issuance of an order revoking Petitioner’s Certificate of Registration (COR).¹  CMS also upheld the imposition of a five-year bar to reenrollment and the inclusion of Petitioner on its Preclusion List.  Because CMS had a legal basis for its determinations, I affirm CMS’s determinations.

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I.  Background and Procedural History

Petitioner, a physician, is licensed to practice medicine in Florida.  CMS Ex. 7 at 1.  On December 15, 2021, the DEA Administrator issued an “Order to Show Cause and Immediate Suspension of the Registration” (Order) to Petitioner.  CMS Ex. 2.  The Order stated that Petitioner “issued numerous prescriptions for controlled substances . . . outside of the usual course of professional practice and not for a legitimate medical purpose, including as recently as November 3, 2021.”  CMS Ex. 2 at 3.  In support, the Order explained that Petitioner “repeatedly prescribed methadone in combination with oxycodone, another Schedule II opioid, on a long-term basis without justification.”  CMS Ex. 2 at 3 (footnote omitted).  The Order reported that Petitioner had prescribed a total of 371 prescriptions to four patients over the span of several years and that his “ongoing prescribing of dangerous opioids outside the usual course of professional practice poses an ‘imminent danger’ within the meaning of 21 U.S.C. § 824(d).”  CMS Ex. 2 at 3-5. 

The Order suspended Petitioner’s DEA COR effective immediately because his “continued registration during the pendency of these proceedings would constitute ‘an imminent danger to the public health or safety’ because of the substantial likelihood of an imminent threat that death, serious bodily harm, or abuse of controlled substances will occur in the absence of this suspension.”  CMS Ex. 2 at 5.  The Order also directed Petitioner to show cause “as to why DEA should not revoke [his] registration pursuant to 21 U.S.C. § 824(a)(4), and deny any pending applications for renewal or modification of such registration, or for additional DEA registrations, because [his] continued registration is inconsistent with the public interest, as that term is defined in 21 U.S.C. § 823(f).”  CMS Ex. 2 at 1.  

The following month, on January 18, 2022, First Coast informed Petitioner that it was revoking his Medicare privileges, effective February 17, 2022, pursuant to 42 C.F.R. § 424.535(a)(13).  CMS Ex. 3 at 1.  First Coast also informed Petitioner that it had imposed a five-year bar to reenrollment, and that Petitioner would be included on CMS’s Preclusion List pursuant to 42 C.F.R. §§ 422.2, 422.222, 423.100, and 423.120(c)(6).  CMS Ex. 3 at 1, 3. 

On May 6, 2022, Petitioner entered into a memorandum of agreement with the DEA in which he “accept[ed] responsibility for the misconduct alleged in the Order to Show Cause” and agreed to “surrender” his DEA COR and withdraw his hearing request.  CMS Ex. 5 at 2.  Petitioner agreed that he would not reapply for a COR for schedule III, IV, and V drugs until December 15, 2023, and that he would not file an application for schedule II, IIN, or IIIN authority until December 16, 2024.  CMS Ex. 5 at 2.  Petitioner also “agree[d] that he [would] undertake the continuing education and compliance monitoring that he proposed in paragraphs 3 and 4 of his May 3, 2022 settlement proposal.”  CMS Ex. 5 at 2; see CMS Ex. 4 at 2 (Petitioner’s discussion that the settlement included continuing medical education regarding pharmacotherapy and

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controlled substances and concurrent review of documentation of prescribing habits for 12 months).

Petitioner submitted an undated request for reconsideration in which he reported that his DEA COR had been “temporarily suspended” and that he had agreed to a settlement in May 2022.²  CMS Ex. 4 at 1.  Petitioner also acknowledged that “Medicare has the ability to revoke [his] enrollment in Medicare because of [his] DEA suspension,” but denied that the DEA investigation proved improper prescribing practices.  CMS Ex. 4 at 2. 

CMS, through its Provider Enrollment and Oversight Group, issued a reconsidered determination on May 10, 2023, in which it upheld the revocation of Petitioner’s Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(13), the imposition of a five-year bar to reenrollment, and his placement on the Preclusion List.  CMS Ex. 1.  In upholding Petitioner’s revocation, CMS explained that it “must only establish that a physician’s . . . DEA COR has been suspended or revoked.”  CMS Ex. 1 at 3. 

CMS also determined that, pursuant to the factors outlined at 42 C.F.R. §§ 422.2 and 423.100, Petitioner should be placed on the Preclusion List.  CMS Ex. 1 at 4-6.  CMS explained that the first two factors set forth in 42 C.F.R. §§ 422.2 and 423.100 were met, as Petitioner’s enrollment had been revoked and a five-year reenrollment bar had been imposed.  CMS Ex. 1 at 4.  The third and final factor was also met because the underlying conduct that led to Petitioner’s revocation was detrimental to the best interests of the Medicare program.  CMS Ex. 1 at 5-6; see also 42 C.F.R. §§ 422.2 and 423.100.  In its discussion, CMS considered the relevant subfactors, which include: the seriousness of the conduct underlying the conviction, the degree Petitioner’s conduct could affect the integrity of the Medicare program, and other evidence that it deemed relevant.  CMS Ex. 1 at 5-6.  The discussion also highlighted the DEA’s statement that Petitioner’s continued registration “would constitute ‘an imminent danger to the public health or safety’ because of the substantial likelihood of an imminent threat that death, serious bodily harm, or abuse of controlled substances will occur in the absence of this suspension.”  CMS Ex. 1 at 5.  Finally, CMS noted that the Preclusion List had been implemented pursuant to a congressional mandate to “establish a program to prevent prescription drug abuse by Medicare beneficiaries under Medicare Parts C and D.”  CMS Ex. 1 at 5.  

Petitioner filed a request for hearing on July 9, 2023.  CMS filed a combined brief and motion for summary judgment (CMS Br.), along with seven proposed exhibits (CMS Exs. 1-7).  Petitioner submitted a pre-hearing brief in opposition to the motion for

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summary judgment (P. Br.).³  CMS filed a reply.  In the absence of any pending objections, I admit CMS Exs. 1-7 into the evidentiary record. 

Neither party has submitted the written direct testimony of any witnesses, and a hearing is therefore unnecessary for the purpose of cross-examination of any witnesses.  Pre-Hearing Order §§ 12-14.  I issue this decision on the merits.⁴ 

II.  Issues 

Whether CMS had a legitimate basis to uphold the revocation of Petitioner’s Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(13). 

Whether CMS had a legitimate basis to uphold Petitioner’s placement on its Preclusion List.  

III.  Jurisdiction

I have jurisdiction to decide these issues.  42 C.F.R. §§ 498.1(g), 498.3(b)(17)(i) and (20), 498.5(l)(2); see also 42 U.S.C. § 1395cc(j)(8). 

IV.  Findings of Fact, Conclusions of Law, and Analysis⁵

As a physician, Petitioner is a supplier of health care services for purposes of the Medicare program.  42 U.S.C. § 1395x(d); 42 C.F.R. §§ 400.202 (supplier), 410.20(b)(1).  In order to participate in the Medicare program as a supplier, an individual must meet certain criteria to enroll and receive billing privileges.  42 C.F.R. §§ 424.505, 424.510.  CMS may revoke a supplier’s enrollment for any reason stated in, inter alia, 42 C.F.R. § 424.535(a).  A supplier’s Medicare enrollment can be revoked as set forth in 42 C.F.R. § 424.535(a)(13): 

(13)  Prescribing authority.

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(i) A physician or other eligible professional’s Drug Enforcement Administration (DEA) Certificate of Registration to dispense a controlled substance is currently suspended or revoked or is surrendered in response to an order to show cause.

(ii) The applicable licensing or administrative body for any state in which the physician or eligible professional practices suspends or revokes the physician or eligible professional’s ability to prescribe drugs. 

CMS is authorized to impose a bar to reenrollment for a minimum of one year, but no more than ten years.  42 C.F.R. § 424.535(c)(1)(i). 

Additionally, CMS has established a single list of providers and prescribers who are precluded from being reimbursed for Medicare Advantage items or services or Part D drugs they furnish or prescribe to Medicare beneficiaries.  42 C.F.R. §§ 422.222, 423.120(c)(6).  As relevant here, CMS may place an individual, entity, or prescriber on its Preclusion List under the following circumstances:  

(i)     The [individual, entity, or prescriber] is currently revoked from Medicare for a reason other than that stated in § 424.535(a)(3) of this chapter.
(ii)     The individual or entity is currently under a reenrollment bar under § 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 1(iii), CMS considers the following factors:  

(A) The seriousness of the conduct underlying the individual’s or entity’s revocation.  
(B) The degree to which the individual’s or entity’s conduct could affect the integrity of the Medicare program.  
(C) Any other evidence that CMS deems relevant to its determination. 

42 C.F.R. §§ 422.2 (Preclusion List), 423.100 (Preclusion List). 

1. On December 15, 2021, the DEA Administrator issued an order to show cause that suspended Petitioner’s DEA COR. 

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2. On January 18, 2022, a Medicare administrative contractor revoked Petitioner’s enrollment pursuant to 42 C.F.R. § 424.535(a)(13), which authorizes the revocation of the enrollment of a supplier whose DEA COR has been suspended.  
3. Petitioner does not dispute that his DEA COR had been suspended at the time of the initial determination revoking his Medicare enrollment. 
4. Petitioner, in a May 2022 settlement agreement with the DEA in which he agreed to surrender his DEA COR, accepted responsibility for the misconduct outlined in the DEA’s Order. 
5. Petitioner does not dispute that CMS was authorized to revoke his Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(13) because the DEA had suspended his DEA COR.  
6. Petitioner does not dispute that CMS was authorized to impose a five-year bar to reenrollment pursuant to 42 C.F.R. § 424.535(c), and I may not review CMS’s exercise of its discretion with respect to the length of a reenrollment bar.  
7. CMS had a legitimate basis to uphold the revocation of Petitioner’s enrollment application pursuant to 42 C.F.R. § 424.535(a)(13) because the DEA had suspended his COR. 
8. CMS had a legitimate basis to uphold Petitioner’s placement on its Preclusion List pursuant to 42 C.F.R. §§ 422.2, 423.100, based on its determinations that Petitioner’s Medicare enrollment had been revoked, he was under an active reenrollment bar, and the conduct underlying his revocation was detrimental to the Medicare program.  

Petitioner does not dispute that CMS was authorized to revoke his Medicare enrollment; CMS had a legitimate basis to uphold the revocation of Petitioner’s Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(13).  

The DEA suspended Petitioner’s DEA COR on December 15, 2021, which is not disputed by Petitioner.  CMS Ex. 2; see CMS Ex. 4.  Although Petitioner disagrees with the revocation of his enrollment, he does not argue that CMS lacked the authority to revoke his Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(13).  P. Br.  

The Departmental Appeals Board (DAB) has explained that “[t]he ALJ’s . . . role in an appeal of CMS’s . . . revocation of enrollment in the Medicare program is to determine

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whether CMS had a legal basis for its action,” and “[i]f it did, then [the ALJ is] bound to affirm the . . . revocation.”  Dr. Robert Kanowitz, DAB No. 2942 at 4 (2019).  The DAB has further explained that “the right to review of CMS’s determination by an ALJ serves to determine whether CMS had the authority to revoke [the petitioner’s] Medicare billing privileges, not to substitute the ALJ’s discretion about whether to revoke.”  Letantia Bussell, M.D., DAB No. 2196 at 13 (2008) (emphasis omitted).  As such, the scope of my review is whether CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment. 

Pursuant to 42 C.F.R. § 424.535(a)(13), CMS may revoke the enrollment of a supplier whose DEA COR has been revoked or suspended, or was surrendered in response to a show cause order.  Because the Administrator suspended Petitioner’s DEA COR, CMS was authorized to revoke his Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(13).  See CMS Exs. 1, 2, 4.  The evidence demonstrates that CMS had a legitimate basis to revoke Petitioner’s enrollment.  

Petitioner argues that CMS counsel misstated the number of patients that were cited in the DEA’s Order, correctly arguing that that Order addressed four specific patients.  P. Br.  Petitioner also argues that he has “never been a defendant in any legal proceedings relative to patients under [his] care” and “there have been no citations nor any deficits when it comes to inspections from the Florida Board of Medicine, the Florida Department of Health, or the Agency of Healthcare Administration” and his “medical license has never been encumbered.”  P. Br.  Petitioner also argues that the Inspector General declined to impose an exclusion from federal healthcare programs.   P. Br. 

As I previously explained, the nature of my review is whether CMS was authorized to revoke Petitioner’s enrollment pursuant to 42 C.F.R. § 424.535(a)(13); see Dr. Robert Kanowitz, DAB No. 2942 at 4.  Though I have no reason to question the veracity of the aforementioned claims by Petitioner, the sole matter before me is whether CMS was authorized to revoke Petitioner’s Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(13) based on the DEA’s suspension of his COR, and not whether I would have taken the same action.  Because the DEA suspended Petitioner’s DEA COR and CMS is authorized, pursuant to 42 C.F.R. § 424.535(a)(13), to revoke enrollment when a DEA COR has been revoked or suspended or surrendered in response to a show cause order, CMS had a legitimate basis to revoke Petitioner’s enrollment.  

Petitioner is subject to a five-year bar to re-enrollment. 

Pursuant to 42 C.F.R. § 424.535(c), CMS is authorized to impose a bar to reenrollment of up to ten years when it has revoked a supplier’s enrollment.  In its reconsidered determination, CMS upheld the five-year bar to reenrollment.  CMS Ex. 1 at 4.  The DAB has unambiguously explained that such a matter is beyond the scope of an ALJ’s review, stating:

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A decision by CMS or its contractor about how long to bar a revoked supplier from re-enrolling in Medicare, unlike the determination to revoke the supplier’s billing privileges, is not an appealable “initial determination” under 42 C.F.R. Part 498.  Blossomwood Medical, P.C., et al., DAB No. 2914 at 11 (2018); Vijendra Dave, M.D. [DAB No. 2672] at 8-11 [(2016)] (stating that the authority of an ALJ or the Board in a revocation appeal “does not extend to reviewing the length of the reenrollment bar imposed by CMS”).  We therefore cannot consider or act upon Petitioner’s contention that the three-year re-enrollment bar was excessive in her circumstances.  

Linda Silva, P.A., DAB No. 2966 at 11 (2019).  Petitioner has not identified any legal error in CMS’s imposition of the reenrollment bar, and I may not otherwise review the duration of the reenrollment bar.  See Dave, DAB No. 2672 at 11 (“CMS’s determination regarding the duration of the re-enrollment bar is not reviewable.”). 

CMS had a legitimate basis to uphold Petitioner’s inclusion on its Preclusion List. 

Petitioner argues that CMS relied on the DEA’s Order without interviewing the patients or reviewing the charts for the patients.  P. Br.  Petitioner also argues that the IG declined to impose an exclusion and that the Order addressed his prescriptions to four (and not five) specific patients.  P. Br.  Petitioner further states that he intends to apply for “partial DEA certification” in December 2023.  P. Br. 

Based on its consideration of the regulatory factors set forth in 42 C.F.R. §§ 422.2 and 423.100, CMS had a legitimate basis to uphold Petitioner’s placement on the Preclusion List.  In assessing a placement on the Preclusion List pursuant to 42 C.F.R. §§ 422.2 and 423.100, CMS is required to consider, in the case of a revoked supplier who is under a reenrollment bar, whether the underlying conduct that led to the revocation is detrimental to the best interests of the Medicare program based on its consideration of enumerated subfactors, which it did.  CMS’s reconsidered determination demonstrates that it considered all required factors at 42 C.F.R. §§ 422.2 and 423.100, and I do not question CMS’s exercise of its discretion.  See, e.g., Abdul Razzaque Ahmed, M.D., DAB No. 2261 at 19 (2009), aff’d, Ahmed v. Sebelius, 710 F. Supp. 2nd 167 (D. Mass. 2010) (addressing the role of an ALJ in the context of reviewing CMS’s exercise of its discretion and not substituting his or her discretion when CMS had established the necessary regulatory elements).  Even if I could exercise discretion in place of CMS, which I cannot, the evidence amply supports that Petitioner admitted to the misconduct outlined in the Order that included “prescribing dangerous opioids” such that it posed “‘imminent danger’ within the meaning of 21 U.S.C. § 824(d).”  CMS Ex. 2 at 5.

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Petitioner’s behavior is precisely what Congress sought to thwart when it enacted the legislation that led to CMS’s implementation of the Preclusion List.⁶  CMS Ex. 2; CMS Ex. 5 at 2 (Petitioner’s acceptance of responsibility for the misconduct outlined in the Order).  

In its reconsidered determination, CMS provided extensive support for its determination that Petitioner would be placed on its Preclusion List, stating: 

Regarding the first factor, [Petitioner] is currently revoked from the Medicare program effective February 17, 2022, pursuant to [section] 424.535(a)(13).  Regarding the second factor, [Petitioner] is also subject to a re-enrollment bar under [section] 424.535(c), for five years, effective 30 days from the date of the January 18, 2022 letter.  Both the revocation and re-enrollment bar are upheld by this decision. 

Regarding the third factor, CMS must determine whether the conduct that led to the revocation is detrimental to the best interests of the Medicare program.  In making this determination, CMS considers the following:

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(A) The seriousness of the conduct underlying the individual’s or entity’s revocation;
(B) The degree to which the individual’s or entity’s conduct could affect the integrity of the Medicare program; and
(C) Any other evidence that CMS deems relevant to its determination. 

Regarding factor (A), the suspension of [Petitioner’s] DEA COR led to the revocation of his Medicare enrollment pursuant to § 424.535(a)(13).  CMS considers the suspension of a DEA COR for prescribing, ordering, and/or delegating the prescribing or ordering of, any substances listed in Schedules I-V, to be very serious in nature.  Furthermore, the suspension of a DEA COR is a clear indicator to CMS that the physician or eligible professional may be misusing or abusing their authority to prescribe such substances.  Therefore, CMS finds that the conduct which led to the revocation of [Petitioner’s] Medicare enrollment to be very serious. 

Regarding factor (B), [Petitioner’s] DEA COR was suspended because, from August 2017 through November 2021, [Petitioner] prescribed methadone, a Schedule II opioid, in combination with oxycodone, another Schedule II opioid, on a long-term basis without justification.  Additionally, [Petitioner]⁷ made no attempts to make significant reductions nor find alternative treatments for these five patients who were all prescribed this combination for medication for at least two years.  CMS finds that [Petitioner’s] inappropriate prescribing of controlled substances is very alarming and represents a serious threat to the Medicare program and the health and safety of its beneficiaries.  CMS also finds that [Petitioner’s] actions demonstrate a propensity for dangerous and non-compliance [sic] behavior, as well as a complete disregard for federal government rules and regulations.  Furthermore, [Petitioner’s] actions also call into question his ability to be a trustworthy Medicare partner.  CMS is responsible for protecting Medicare beneficiaries and the Medicare Trust Funds, and that integrity of the Medicare program is dependent on the reliability, integrity, and good judgment of its partners.  Therefore, [Petitioner’s] participation in the Medicare program would negatively affect the integrity of the Medicare program. 

Regarding factor (C), CMS also finds it relevant that, in addition to prescribing these medications to multiple patients, [Petitioner] prescribed this combination of methadone and oxycodone for almost four years to two

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patients that live in the same home, and did not properly address why one of the patients tested negative for use of these prescribed drugs.  The DEA notes that [Petitioner’s] continued registration would constitute “an imminent danger to the public health or safety” because of the substantial likelihood of an imminent threat that death, serious bodily harm or abuse of controlled substances will occur in the absence of this suspension. . . . 

In addition, the DEA COR suspension notice states that [Petitioner’s] unlawful prescribing practices of dangerous opioids outside the usual [course] of professional practice poses an imminent danger to his patients. . . .  The CMS Preclusion List was established to prevent prescription drug abuse by Medicare beneficiaries under Medicare Parts C and D.  Although [Petitioner] is a Medicare provider and not a Medicare beneficiary, the dangerous prescribing by [Petitioner] that led to the suspension of his DEA COR in Florida is precisely the type of conduct that the CMS Preclusion List was intended to deter within the Medicare program.  In creating the CMS Preclusion List, CMS noted that, “the inclusion of problematic prescribers on the [P]reclusion [L]ist could reduce the 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. 56,336, 56,444.  The Medicare program is at serious risk if we allow our Medicare providers and suppliers, like [Petitioner], to engage in improper prescribing practices while seeking to prevent and prohibit prescription drug abuse by its beneficiaries.  

CMS Ex. 1 at 4-6. 

Petitioner has not argued that CMS failed to consider any regulatory factor when it exercised its discretion and upheld Petitioner’s placement on the Preclusion List.  P. Br.  Rather, Petitioner denies that he engaged in the misconduct outlined in the DEA Administrator’s Order revoking his COR, inasmuch as he claims that CMS should not have relied on the DEA’s investigation without performing its own investigation.  P. Br.; see CMS Ex. 5 at 2.  Petitioner points to no authority that requires CMS to adjudicate, in the first instance, whether the DEA Administrator’s Order was erroneous, particularly when Petitioner accepted responsibility for the misconduct that was revealed by the DEA’s investigation.  See CMS Ex. 5 at 2.  Rather, pursuant to 42 C.F.R. §§ 422.2 and 423.100, CMS evaluates “the conduct underlying the revocation,” which was the prescribing practices that led to the suspension of his DEA COR.  CMS considered this conduct, which was detailed in the Order and conceded by Petitioner, and acted within its discretion to uphold Petitioner’s inclusion on its Preclusion List.  See CMS Exs. 1 at 4-6; 2 at 3-5; 5 at 2. 

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V.  Conclusion

I affirm the revocation of Petitioner’s Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(13) and inclusion on CMS’s Preclusion List.

Endnotes

¹  “Every person who manufactures, distributes, dispenses, imports, or exports any controlled substance or who proposes to engage in the manufacture, distribution, dispensing, importation, or exportation of any controlled substances shall obtain a registration unless exempted by law. . . .”  21 C.F.R. § 1301.11(a).

²  The reconsidered determination reports that CMS received the request on March 10, 2023.  CMS Ex. 1 at 2.  CMS reported that the reconsideration request was not timely but that “a good cause waiver has been granted.”  CMS Ex. 1 at 1.

³  Petitioner’s brief, submitted as a Word document, is not paginated.  Therefore, I do not provide pinpoint citations to Petitioner’s brief.

⁴  Because an in-person hearing is unnecessary, I need not rule on CMS’s motion for summary judgment. 

⁵  My findings of fact and conclusions of law are in bold and italics.

⁶  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 of the Department of Health and Human Services (Secretary) to establish a program to prevent prescription drug abuse under Medicare Parts C and D.  Id. at 742-52.  Among other things, Section 704 amended the Social Security 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.  Id. at 742-48.  Section 704(g) of the CARA directed the Secretary to promulgate regulations implementing the provisions of that section of the act.  Id. 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.”  Id. at 751.  Additionally, Section 704(b)(2) of the CARA specifically amended the Social Security 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.”  Id. at 748.  CMS proposed rulemaking to implement the CARA on November 28, 2017.  82 Fed. Reg. 56,336.  Consistent with the CARA’s mandate, the final rule established a Preclusion list, effective January 1, 2019.  83 Fed. Reg. 16,440 (Apr. 16, 2018).

⁷  This specific reference misstates Petitioner’s name.