Collapse to view only § 1395w-151. Definitions; treatment of references to provisions in part C
- § 1395w-151. Definitions; treatment of references to provisions in part C
- § 1395w-152. Miscellaneous provisions
- § 1395w-153. Condition for coverage of drugs under this part
- § 1395w-154. Improved Medicare prescription drug plan and MA–PD plan complaint system
§ 1395w–151. Definitions; treatment of references to provisions in part C
(a) Definitions
For purposes of this part:
(1) Basic prescription drug coverage
(2) Covered part D drug
(3) Creditable prescription drug coverage
(4) Part D eligible individual
(5) Fallback prescription drug plan
(6) Initial coverage limit
(7) Insurance risk
(8) MA plan
(9) MA–PD plan
(10) Medicare Prescription Drug Account
(11) PDP approved bid
(12) PDP region
(13) PDP sponsor
(14) Prescription drug plan
The term “prescription drug plan” means prescription drug coverage that is offered—
(A) under a policy, contract, or plan that has been approved under section 1395w–111(e) of this title; and
(B) by a PDP sponsor pursuant to, and in accordance with, a contract between the Secretary and the sponsor under section 1395w–112(b) of this title.
(15) Qualified prescription drug coverage
(16) Standard prescription drug coverage
(17) State Pharmaceutical Assistance Program
(18) Subsidy eligible individual
(b) Application of part C provisions under this part
For purposes of applying provisions of part C under this part with respect to a prescription drug plan and a PDP sponsor, unless otherwise provided in this part such provisions shall be applied as if—
(1) any reference to an MA plan included a reference to a prescription drug plan;
(2) any reference to an MA organization or a provider-sponsored organization included a reference to a PDP sponsor;
(3) any reference to a contract under section 1395w–27 of this title included a reference to a contract under section 1395w–112(b) of this title;
(4) any reference to part C included a reference to this part; and
(5) any reference to an election period under section 1395w–21 of this title were a reference to an enrollment period under section 1395w–101 of this title.
(Aug. 14, 1935, ch. 531, title XVIII, § 1860D–41, as added Pub. L. 108–173, title I, § 101(a)(2), Dec. 8, 2003, 117 Stat. 2148; amended Pub. L. 117–169, title I, § 11201(e)(6), Aug. 16, 2022, 136 Stat. 1892.)
§ 1395w–152. Miscellaneous provisions
(a) Access to coverage in territories
(b) Application of demonstration authority
(c) Coverage gap rebate for 2010
(1) In general
(2) Limitation
(d) Treatment of certain complaints for purposes of quality or performance assessment
(e) Essential retail pharmacies
(1) In generalWith respect to plan years beginning on or after January 1, 2028, the Secretary 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 offering prescription drug plans and MA organizations offering MA–PD plans under this part to essential retail pharmacies (as defined in paragraph (2)) with respect to the dispensing of covered part D drugs, including 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 offering prescription drug plans and MA organizations offering MA–PD plans under this part by essential retail pharmacies with respect to the dispensing of covered part D drugs, including 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 offered by PDP sponsors and MA–PD plans offered by MA organizations under this part, including 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 variation in such trends by geographic region or other factors;
(E) a comparison of cost-sharing for covered part D drugs dispensed by essential retail pharmacies that are network pharmacies for prescription drug plans offered by PDP sponsors and MA–PD plans offered by MA organizations under this part and cost-sharing for covered part D drugs 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 dispensed by essential retail pharmacies that are network pharmacies for prescription drug plans offered by PDP sponsors and MA–PD plans 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 information on any patterns or trends in such comparison specific to certain types of covered part D drugs, such as generic drugs or drugs specified as specialty drugs by a PDP sponsor under a prescription drug plan or an MA organization under an MA–PD plan; and
(G) a comparison of the information described in subparagraphs (A) through (F) between essential retail pharmacies that are network pharmacies for prescription drug plans offered by PDP sponsors under this part and essential retail pharmacies that are network pharmacies for MA–PD plans offered by MA organizations under this part.
(2) Definition of essential retail pharmacyIn 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); 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;
(ii) a suburban area in which there is no other retail pharmacy within 2 miles, as determined by the Secretary; or
(iii) an urban area in which there is no other retail pharmacy within 1 mile, as determined by the Secretary.
(3) List of essential retail pharmacies
(A) Publication of list of essential retail pharmacies
(B) Required submissions from PDP sponsors
(C) Reporting by PDP sponsors and MA organizations
(D) Implementation
(E) Nonapplication of Paperwork Reduction Act
(4) Definition of affiliate; pharmacy benefit manager
(f) Biennial report on enforcement and oversight of pharmacy access requirements
(1) In general
(2) LimitationA report under paragraph (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.
(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.)
§ 1395w–153. Condition for coverage of drugs under this part
(a) In generalIn order for coverage to be available under this part for covered part D drugs (as defined in section 1395w–102(e) of this title) of a manufacturer, the manufacturer must—
(1) participate in—
(A) for 2011 through 2024, the Medicare coverage gap discount program under section 1395w–114a of this title; and
(B) for 2025 and each subsequent year, the manufacturer discount program under section 1395w–114c of this title;
(2) have entered into and have in effect—
(A) for 2011 through 2024, an agreement described in subsection (b) of section 1395w–114a of this title with the Secretary; and
(B) for 2025 and each subsequent year, an agreement described in subsection (b) of section 1395w–114c of this title with the Secretary; and
(3) have entered into and have in effect, under terms and conditions specified by the Secretary, a contract with a third party that the Secretary has entered into a contract with under subsection (d)(3) of section 1395w–114a of this title.
(b) Effective date
(c) Authorizing coverage for drugs not covered under agreements
(1) In generalSubject to paragraph (2), subsection (a) shall not apply to the dispensing of a covered part D drug if—
(A) the Secretary has made a determination that the availability of the drug is essential to the health of beneficiaries under this part; or
(B) the Secretary determines that in the period beginning on January 1, 2011, and 1
1 So in original. Probably should be followed by “ending on”.
December 31, 2011, there were extenuating circumstances.(2) Exception
(d) Definition of manufacturer
(Aug. 14, 1935, ch. 531, title XVIII, § 1860D–43, as added Pub. L. 111–148, title III, § 3301(a), Mar. 23, 2010, 124 Stat. 461; amended Pub. L. 111–152, title I, § 1101(b)(1), Mar. 30, 2010, 124 Stat. 1037; Pub. L. 117–169, title I, §§ 11001(b)(1)(G)(i), 11201(e)(7), Aug. 16, 2022, 136 Stat. 1853, 1892.)
§ 1395w–154. Improved Medicare prescription drug plan and MA–PD plan complaint system
(a) In general
(b) Model electronic complaint form
(c) Annual reports by the Secretary
(d) Definitions
In this section:
(1) MA–PD plan
(2) Prescription drug plan
(3)
(4) System
(Pub. L. 111–148, title III, § 3311, Mar. 23, 2010, 124 Stat. 475.)