DECISION & ORDER On August 16, 2021, the plaintiff, Louis J. Pawlowski, DNP, filed this action. Docket Item1. He alleged that the defendants, United States Department of Health and Human Services (“HHS”) Secretary Xavier Becerra and National Government Services, Inc. (“NGS”) (collectively, “the government”), violated his due process rights when they notified him that his Medicare enrollment would be revoked on August 22, 2021. Id. That same day, Dr. Pawlowski also moved for a temporary restraining order and a preliminary injunction.1 Docket Item 3. Soon after, the parties stipulated that any revocation of Dr. Pawlowski’s Medicare enrollment and billing privileges and any resulting inclusion on the Centers for Medicare and Medicaid Services (“CMS”) preclusion list would not become effective until twenty-one days after CMS decided Dr. Pawlowski’s request for reconsideration of that decision. Docket Item 15. The government then moved to dismiss on September 16, 2021. Docket Item 23. After Dr. Pawlowski filed an amended complaint, Docket Item 27, the government renewed its motion to dismiss on October 21, 2021, Docket Item 31. Dr. Pawlowski responded on November 8, 2021, Docket Item 37, and the government replied on November 15, 2021, Docket Item 38. This Court held oral argument on the government’s motion on November 19, 2021, Docket Item 39, and the parties then submitted additional briefing, see Docket Items 41, 43. In the meantime, on October 15, 2021, Dr. Pawlowski asked CMS to reconsider the revocation and preclusion decisions. See Docket Item 38-2. On January 28, 2022, CMS notified Dr. Pawlowski that it upheld the initial determination to revoke his Medicare enrollment, bar him from re-enrollment for ten years, and place him on the CMS preclusion list. Docket Item 44. After an additional extension of time, the effective date of the revocation of Dr. Pawlowski’s enrollment and his placement on the preclusion list was extended until March 4, 2022. Docket Item 46. For the following reasons, the government’s motion to dismiss is granted, and Dr. Pawlowski’s motion for a preliminary injunction therefore is denied as moot. FACTUAL BACKGROUND Dr. Pawlowski is a “nurse practitioner who holds a Doctorate in Nursing Practice” and “specializes in pain management.” Docket Item 27 at 11. He “has a private practice with a principal place of business in Orchard Park, New York.” Id. “Since 2004[,] he has been enrolled with CMS to be reimbursed for services provided to Medicare beneficiaries.” Id. Medicare reimbursement makes up about half the revenue of Dr. Pawlowski’s practice. Id. at 20. On October 2, 2020, Qlarant, an “Investigations Medicare Drug Integrity Contractor” that contracts with CMS to “conduct program-integrity functions,” sent Dr. Pawlowski a letter “infor[ming] [him] that Qlarant[]…[would] be conducting a review of medical and/or prescription records for [his] patients.” Docket Item 31-4 at 2. Qlarant requested medical records associated with certain beneficiaries, including information related to opioid prescriptions. Id. at 2-3. Although any response from Dr. Pawlowski was “voluntary,” Qlarant informed him that it was “required to notify CMS” if he failed to supply the requested records. Id. at 3. Dr. Pawlowski responded with the requested records on October 29, 2020. See Docket Item 31-5. Nearly nine months passed before Dr. Pawlowski received a letter from NGS, the Medicare Administrative Contractor that covers New York, notifying him that his Medicare enrollment and “privileges [would be] revoked effective August 22, 2021.” Docket Item 27-1 at 2; Docket Item 27 at
13, 26. That letter informed Dr. Pawlowski that CMS had “determined that [he] ha[d] engaged in a pattern or practice of prescribing Part D drugs that represents a threat to the health and safety of Medicare beneficiaries” in violation of 42 C.F.R. §424.535(a)(14)(i). See Docket Item 27-1 at 2; Docket Item 27 at 26. That regulation provides that a supplier’s Medicare enrollment may be revoked if “CMS determines that the physician or eligible professional has a pattern or practice of prescribing Part B or D drugs that…is abusive or represents a threat to the health and safety of Medicare beneficiaries or both.” 42 C.F.R. §424.535(a)(14)(i). “In making [that] determination,” CMS considers, among other factors, “[w]hether the physician or eligible professional has prescribed controlled substances in excessive dosages that are linked to patient overdoses,” id. §424.535(a)(14)(i)(C), as well as “[a]ny other relevant information provided to CMS,” id. §424.535(a)(14)(i)(H). The July 23 letter invoked those factors as bases for the revocation. First, the letter noted that Dr. Pawlowski had “prescribed excessive dosages of opioids that [were] linked to three [] patient overdoses[]” for two “ unique beneficiaries,” in “violation of [42 C.F.R. §] 424.535(a)(14)(i)(C).” Docket Item 27-1 at 2. The letter also noted “inappropriate prescribing behavior” and “high-opioid dosages [that] were not supported by the records and documentation,” both in violation of 42 C.F.R. §424.535(a)(14)(i)(H). Id. The letter informed Dr. Pawlowski that as a result of the revocation of his Medicare enrollment, he also would be placed on the CMS preclusion list and would be barred from submitting an application to re-enroll for ten years. Id. at 3, 5. The letter notified Dr. Pawlowski that he had the “right to submit [a] reconsideration request,” which would result in “an independent review conducted by a person not involved in the initial determination.” Id. at 3 (capitalization removed). But because the revocation was set to go into effect on August 22, 2021, any decision on Dr. Pawlowski’s reconsideration request would almost certainly come after his privileges had been revoked. Id. at 2. So Dr. Pawlowski sought immediate relief in this Court to stay the effective date of the revocation, see Docket Item 3, after which the government stipulated that the effective date of any revocation and inclusion on the preclusion list would be stayed until twenty-one days after a decision on Dr. Pawlowski’s reconsideration request, see Docket Item 15. On September 7, 2021, Dr. Pawlowski requested additional documents related to the July 23 letter, including medical records associated with the initial revocation decision. See Docket Item 31-2 at 9; Docket Item 31-6. On October 15, 2021, he submitted his request for reconsideration. See Docket Item 31-2 at 14; Docket Item 38-2. That request ran over 300 pages and attached fifteen exhibits, which included “supplemental medical records” for nine patients as well as affidavits from three physicians and a medical billing expert. See Docket Item 38-1 at 4; Docket Item 38-2. CMS denied Dr. Pawlowski’s request for reconsideration on January 28, 2022. Docket Item 44. More specifically, CMS concluded that “Dr. Pawlowski engaged in a pattern or practice of prescribing drugs [that] is abusive and/or represents a threat to the health and safety of Medicare beneficiaries” and consequently “uph[eld] the revocation of Dr. Pawlowski’s Medicare enrollment pursuant to [42 C.F.R.] §424.535(a)(14).” Id. at 19. Likewise, CMS upheld the decision to include Dr. Pawlowski on the CMS preclusion list and to impose a ten-year re-enrollment bar beginning on the date that Dr. Pawlowski’s enrollment was revoked. Id. at 19-21. Dr. Pawlowski challenges that entire process. See Docket Item 27. More specifically, he alleges that the defendants “fail[ed] to afford him any opportunity to be heard prior to the revocation determination” and did “not provid[e] him an opportunity to rebut findings that influenced the revocation determination.” Id. at 11-12 (capitalization removed). Dr. Pawlowski also challenges the defendants’ application and interpretation of 42 C.F.R. §424.535(a)(14)(i), certain statements in an introductory section of CMS’s program manual, and the decision to impose a ten-year re-enrollment bar. See id. at
