---
kind: "section"
citation: "42 U.S.C. § 1395w–152"
title: "42"
title_heading: "The Public Health and Welfare"
number: "1395w–152"
heading: "Miscellaneous provisions"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/1395w-152"
units:
  - "Chapter 7 — Social Security"
  - "Subchapter XVIII — Health Insurance for Aged and Disabled"
  - "Part D — Voluntary Prescription Drug Benefit Program"
  - "Subpart 5 — definitions and miscellaneous provisions"
---

# §1395w–152. Miscellaneous provisions

- (a) **Access to coverage in territories—** The [Secretary](/usc/42/1301.md?p=a-6) may waive such requirements of this part, [including](/usc/42/1301.md?p=b) [section 1395w–103(a)(1) of this title](/usc/42/1395w–103.md?p=a-1), insofar as the [Secretary](/usc/42/1301.md?p=a-6) determines it is necessary to secure access to [qualified prescription drug coverage](/usc/42/1395w–151.md?p=a-15) for [part D eligible individuals](/usc/42/1395w–151.md?p=a-4) residing in a [State](/usc/42/619.md?p=5) (other than the 50 [States](/usc/42/619.md?p=5) and the District of Columbia).
- (b) **Application of demonstration authority—** The provisions of [section 402](/usc/42/402.md) of the [Social](/usc/42/1397j.md?p=20) Security Amendments of 1967 (Public Law 90–248) shall apply with respect to this part and part C in the same manner it applies with respect to parts A and B, except that any reference with respect to a Trust Fund in relation to an experiment or demonstration [project](/usc/42/13641.md?p=2) relating to prescription [drug](/usc/42/11851.md?p=4) coverage under this part shall be deemed a reference to the [Medicare Prescription Drug Account](/usc/42/1395w–151.md?p=a-10) within the Federal Supplementary Medical Insurance Trust Fund.
- (c) **Coverage gap rebate for 2010—**
  - (1) **In general—** In the case of an individual described in subparagraphs (A) through (D) of [section 1395w–114a(g)(1) of this title](/usc/42/1395w–114a.md?p=g-1) who as of the last day of a calendar quarter in 2010 has incurred costs for [covered part D drugs](/usc/42/1395w–151.md?p=a-2) so that the individual has exceeded the [initial coverage limit](/usc/42/1395w–151.md?p=a-6) under [section 1395w–102(b)(3) of this title](/usc/42/1395w–102.md?p=b-3) for 2010, the [Secretary](/usc/42/1301.md?p=a-6) shall provide for payment from the [Medicare Prescription Drug Account](/usc/42/1395w–151.md?p=a-10) of $250 to the individual by not later than the 15th day of the third month following the end of such quarter.
  - (2) **Limitation—** The [Secretary](/usc/42/1301.md?p=a-6) shall provide only 1 payment under this subsection with respect to any individual.
- (d) **Treatment of certain complaints for purposes of quality or performance assessment—** In conducting a quality or performance assessment of a [PDP sponsor](/usc/42/1395w–151.md?p=a-13), the [Secretary](/usc/42/1301.md?p=a-6) shall develop or utilize existing screening methods for reviewing and considering complaints that are received from enrollees in a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) offered by such [PDP sponsor](/usc/42/1395w–151.md?p=a-13) and that are complaints regarding the lack of access by the individual to prescription [drugs](/usc/42/11851.md?p=4) due to a [drug](/usc/42/11851.md?p=4) management program for at-risk beneficiaries.
- (e) **Essential retail pharmacies—**
  - (1) **In general—** With respect to plan years beginning on or after January 1, 2028, the [Secretary](/usc/42/1301.md?p=a-6) shall publish reports, at least once every 2 years until 2034, and periodically thereafter, that provide information, to the extent feasible, on—
    - (A) trends in ingredient cost reimbursement, dispensing fees, incentive payments and other fees paid by [PDP sponsors](/usc/42/1395w–151.md?p=a-13) offering [prescription drug plans](/usc/42/1395w–151.md?p=a-14) and MA organizations offering [MA–PD plans](/usc/42/1395w–151.md?p=a-9) under this part to essential retail pharmacies (as defined in [paragraph (2)](#e-2)) with respect to the dispensing of [covered part D drugs](/usc/42/1395w–151.md?p=a-2), [including](/usc/42/1301.md?p=b) a comparison of such trends between essential retail pharmacies and pharmacies that are not essential retail pharmacies;
    - (B) trends in amounts paid to [PDP sponsors](/usc/42/1395w–151.md?p=a-13) offering [prescription drug plans](/usc/42/1395w–151.md?p=a-14) and MA organizations offering [MA–PD plans](/usc/42/1395w–151.md?p=a-9) under this part by essential retail pharmacies with respect to the dispensing of [covered part D drugs](/usc/42/1395w–151.md?p=a-2), [including](/usc/42/1301.md?p=b) a comparison of such trends between essential retail pharmacies and pharmacies that are not essential retail pharmacies;
    - (C) trends in essential retail pharmacy participation in pharmacy networks and preferred pharmacy networks for [prescription drug plans](/usc/42/1395w–151.md?p=a-14) offered by [PDP sponsors](/usc/42/1395w–151.md?p=a-13) and [MA–PD plans](/usc/42/1395w–151.md?p=a-9) offered by MA organizations under this part, [including](/usc/42/1301.md?p=b) a comparison of such trends between essential retail pharmacies and pharmacies that are not essential retail pharmacies;
    - (D) trends in the number of essential retail pharmacies, [including](/usc/42/1301.md?p=b) variation in such trends by geographic region or other factors;
    - (E) a comparison of cost-sharing for [covered part D drugs](/usc/42/1395w–151.md?p=a-2) dispensed by essential retail pharmacies that are network pharmacies for [prescription drug plans](/usc/42/1395w–151.md?p=a-14) offered by [PDP sponsors](/usc/42/1395w–151.md?p=a-13) and [MA–PD plans](/usc/42/1395w–151.md?p=a-9) offered by MA organizations under this part and cost-sharing for [covered part D drugs](/usc/42/1395w–151.md?p=a-2) dispensed by other network pharmacies for such plans located in similar geographic areas that are not essential retail pharmacies;
    - (F) a comparison of the volume of [covered part D drugs](/usc/42/1395w–151.md?p=a-2) dispensed by essential retail pharmacies that are network pharmacies for [prescription drug plans](/usc/42/1395w–151.md?p=a-14) offered by [PDP sponsors](/usc/42/1395w–151.md?p=a-13) and [MA–PD plans](/usc/42/1395w–151.md?p=a-9) offered by MA organizations under this part and such volume of dispensing by network pharmacies for such plans located in similar geographic areas that are not essential retail pharmacies, [including](/usc/42/1301.md?p=b) information on any patterns or trends in such comparison specific to certain types of [covered part D drugs](/usc/42/1395w–151.md?p=a-2), such as generic [drugs](/usc/42/11851.md?p=4) or [drugs](/usc/42/11851.md?p=4) specified as specialty [drugs](/usc/42/11851.md?p=4) by a [PDP sponsor](/usc/42/1395w–151.md?p=a-13) under a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) or an MA organization under an [MA–PD plan](/usc/42/1395w–151.md?p=a-9); and
    - (G) a comparison of the information described in subparagraphs [(A)](#e-1-A) through [(F)](#e-1-F) between essential retail pharmacies that are network pharmacies for [prescription drug plans](/usc/42/1395w–151.md?p=a-14) offered by [PDP sponsors](/usc/42/1395w–151.md?p=a-13) under this part and essential retail pharmacies that are network pharmacies for [MA–PD plans](/usc/42/1395w–151.md?p=a-9) offered by MA organizations under this part.
  - (2) **Definition of essential retail pharmacy—** In this subsection, the term “essential retail pharmacy” means, with respect to a plan year, a retail pharmacy that—
    - (A) is not a pharmacy that is an affiliate as defined in [paragraph (4)](#e-4); and
    - (B) is located in—
      - (i) a rural area in which there is no other retail pharmacy within 10 miles, as determined by the [Secretary](/usc/42/1301.md?p=a-6);
      - (ii) a suburban area in which there is no other retail pharmacy within 2 miles, as determined by the [Secretary](/usc/42/1301.md?p=a-6); or
      - (iii) an urban area in which there is no other retail pharmacy within 1 mile, as determined by the [Secretary](/usc/42/1301.md?p=a-6).
  - (3) **List of essential retail pharmacies—**
    - (A) **Publication of list of essential retail pharmacies—** For each plan year (beginning with plan year 2028), the [Secretary](/usc/42/1301.md?p=a-6) shall publish, on a publicly available internet website of the Centers for Medicare & Medicaid Services, a list of retail pharmacies that meet the criteria described in subparagraphs [(A)](#e-2-A) and [(B)](#e-2-B) of paragraph (2) to be considered an essential retail pharmacy.
    - (B) **Required submissions from PDP sponsors—** For each plan year (beginning with plan year 2028), each [PDP sponsor](/usc/42/1395w–151.md?p=a-13) offering a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) and each MA organization offering an [MA–PD plan](/usc/42/1395w–151.md?p=a-9) shall submit to the [Secretary](/usc/42/1301.md?p=a-6), for the purposes of determining retail pharmacies that meet the criterion specified in [subparagraph (A)](#e-2-A) of paragraph (2), a list of retail pharmacies that are affiliates of such sponsor or organization, or are affiliates of a pharmacy benefit manager acting on behalf of such sponsor or organization, at a time, and in a form and manner, specified by the [Secretary](/usc/42/1301.md?p=a-6).
    - (C) **Reporting by PDP sponsors and MA organizations—** For each plan year beginning with plan year 2027, each [PDP sponsor](/usc/42/1395w–151.md?p=a-13) offering a [prescription drug plan](/usc/42/1395w–151.md?p=a-14) and each MA organization offering an [MA–PD plan](/usc/42/1395w–151.md?p=a-9) under this part shall submit to the [Secretary](/usc/42/1301.md?p=a-6) information on incentive payments and other fees paid by such sponsor or organization to pharmacies, insofar as any such payments or fees are not otherwise reported, at a time, and in a form and manner, specified by the [Secretary](/usc/42/1301.md?p=a-6).
    - (D) **Implementation—** Notwithstanding any other provision of law, the [Secretary](/usc/42/1301.md?p=a-6) may implement this paragraph by program instruction or otherwise.
    - (E) **Nonapplication of Paperwork Reduction Act—** [Chapter 35](/usc/44/chch35.md) of title 44 shall not apply to the implementation of this paragraph.
  - (4) **Definition of affiliate; pharmacy benefit manager—** In this subsection, the terms “affiliate” and “pharmacy benefit manager” have the meaning given those terms in [section 1395w–112(h)(7) of this title](/usc/42/1395w–112.md?p=h-7).
- (f) **Biennial report on enforcement and oversight of pharmacy access requirements—**
  - (1) **In general—** Not later than 2 years after February 3, 2026, and at least once every 2 years thereafter, the [Secretary](/usc/42/1301.md?p=a-6) shall publish a report on enforcement and oversight actions and activities undertaken by the [Secretary](/usc/42/1301.md?p=a-6) with respect to the requirements under [section 1395w–104(b)(1) of this title](/usc/42/1395w–104.md?p=b-1).
  - (2) **Limitation—** A report under [paragraph (1)](#f-1) shall not disclose—
    - (A) identifiable information about individuals or entities unless such information is otherwise publicly available; or
    - (B) trade secrets with respect to any entities.

## Source credit

(Aug. 14, 1935, ch. 531, title XVIII, § 1860D–42, as added Pub. L. 108–173, title I, § 101(a)(2), Dec. 8, 2003, 117 Stat. 2149; amended Pub. L. 111–152, title I, § 1101(a)(1), Mar. 30, 2010, 124 Stat. 1036; Pub. L. 114–198, title VII, § 704(d), July 22, 2016, 130 Stat. 750; Pub. L. 119–75, div. J, title II, § 6223(b), (e), Feb. 3, 2026, 140 Stat. 665, 669.)

## Notes

### Editorial Notes

### References in Text

Section 402 of the Social Security Amendments of 1967, referred to in subsec. (b), is section 402 of Pub. L. 90–248, title IV, Jan. 2, 1968, 81 Stat. 930, which enacted section 1395b–1 of this title and amended section 1395ll of this title.

### Amendments

2026—Subsec. (e). Pub. L. 119–75, § 6223(b), added subsec. (e).

Subsec. (f). Pub. L. 119–75, § 6223(e), added subsec. (f).

2016—Subsec. (d). Pub. L. 114–198 added subsec. (d).

2010—Subsec. (c). Pub. L. 111–152 added subsec. (c).

### Statutory Notes and Related Subsidiaries

### Effective Date of 2016 Amendment

Amendment by Pub. L. 114–198 applicable to prescription drug plans (and MA–PD plans) for plan years beginning on or after Jan. 1, 2019, see section 704(g)(1) of Pub. L. 114–198, set out as a note under section 1395w–101 of this title.