42 U.S.C. § 1395w–152 — Miscellaneous provisions

(a) Access to coverage in territories. The Secretary may waive Part D requirements, including section 1395w–103(a)(1), as far as the Secretary decides is necessary to secure qualified prescription-drug coverage for Part D eligible people living in a State other than the 50 States and the District of Columbia. (b) Demonstration authority. Section 402 of the Social Security Amendments of 1967 (Public Law 90–248) applies to this part and Part C in the same way it applies to Parts A and B. A reference to a Trust Fund for an experiment or demonstration involving prescription-drug coverage under this part is treated as a reference to the Medicare Prescription Drug Account within the Federal Supplementary Medical Insurance Trust Fund. (c) Coverage-gap rebate for 2010. (1) For a person described in section 1395w–114a(g)(1)(A) through (D) who, on the last day of a 2010 calendar quarter, incurred enough covered Part D drug costs to exceed the 2010 initial coverage limit under section 1395w–102(b)(3), the Secretary must arrange for a $250 payment from the Medicare Prescription Drug Account no later than the 15th day of the third month after that quarter ends. (2) The person may receive only one payment under this subsection. (d) Certain complaints in quality or performance assessments. When assessing a PDP sponsor’s quality or performance, the Secretary must develop or use screening methods for reviewing and considering complaints from the sponsor’s prescription-drug-plan enrollees about lack of access to prescription drugs caused by a drug-management program for at-risk beneficiaries. (e) Essential retail pharmacies. (1) Beginning with plan years on or after January 1, 2028, the Secretary must publish reports at least every 2 years through 2034, and periodically afterward, to the extent feasible. The reports must cover: (A) trends in ingredient-cost reimbursement, dispensing fees, incentive payments, and other fees paid by PDP sponsors and MA organizations to essential retail pharmacies for dispensing covered Part D drugs, comparing them with other pharmacies; (B) trends in amounts essential retail pharmacies pay PDP sponsors and MA organizations for such dispensing, with the same comparison; (C) trends in essential pharmacies’ participation in pharmacy and preferred-pharmacy networks, with the same comparison; (D) trends in the number of essential pharmacies, including geographic or other variation; (E) a comparison of enrollee cost-sharing for covered drugs dispensed by essential network pharmacies with cost-sharing at other network pharmacies in similar areas that are not essential; (F) a comparison of the volume of covered drugs dispensed by essential network pharmacies with volume at other network pharmacies in similar areas, including patterns for generic or specialty drugs; and (G) a comparison of the information in (A) through (F) between essential pharmacies in PDP networks and essential pharmacies in MA–PD networks. (2) Definition. For a plan year, an “essential retail pharmacy” is a retail pharmacy that (A) is not an affiliate as defined in paragraph (4), and (B) is in (i) a rural area with no other retail pharmacy within 10 miles, (ii) a suburban area with no other retail pharmacy within 2 miles, or (iii) an urban area with no other retail pharmacy within 1 mile, as determined by the Secretary. (3) Lists and submissions. (A) For every plan year beginning in 2028, the Secretary must publish on a publicly available CMS website a list of pharmacies meeting paragraph (2)(A) and (B). (B) For every such plan year, each PDP sponsor offering a prescription-drug plan and each MA organization offering an MA–PD plan must submit, in the required time, form, and manner, a list of its affiliates and of affiliates of a pharmacy benefit manager acting for it, so the Secretary can apply paragraph (2)(A). (C) Beginning with plan year 2027, each such sponsor and organization must submit information about incentive payments and other fees it pays pharmacies, to the extent not otherwise reported. (D) The Secretary may implement this paragraph by program instruction or otherwise, despite other law. (E) Chapter 35 of title 44, the Paperwork Reduction Act, does not apply to implementing this paragraph. (4) “Affiliate” and “pharmacy benefit manager” have the meanings given in section 1395w–112(h)(7); this section does not define them. (f) Biennial enforcement and oversight report. (1) No later than 2 years after February 3, 2026, and at least every 2 years afterward, the Secretary must publish a report about enforcement and oversight actions concerning section 1395w–104(b)(1). (2) The report may not disclose (A) identifiable information about people or entities unless otherwise publicly available, or (B) entities’ trade secrets.