42 U.S.C. § 1395w-111
The service area for a prescription drug plan shall consist of an entire PDP region established under paragraph (2).
The Secretary shall establish, and may revise, PDP regions in a manner that is consistent with the requirements for the establishment and revision of MA regions under subparagraphs (B) and (C) of section 1395w-27a(a)(2) of this title.
To the extent practicable, PDP regions shall be the same as MA regions under section 1395w-27a(a)(2) of this title. The Secretary may establish PDP regions which are not the same as MA regions if the Secretary determines that the establishment of different regions under this part would improve access to benefits under this part.
The Secretary shall establish, and may revise, PDP regions for areas in States that are not within the 50 States or the District of Columbia.
Nothing in this subsection shall be construed as preventing a prescription drug plan from being offered in more than one PDP region (including all PDP regions).
A PDP sponsor shall submit to the Secretary information described in paragraph (2) with respect to each prescription drug plan it offers. Such information shall be submitted at the same time and in a similar manner to the manner in which information described in paragraph (6) of section 1395w-24(a) of this title is submitted by an MA organization under paragraph (1) of such section.
The information described in this paragraph is information on the following:
The prescription drug coverage provided under the plan, including the deductible and other cost-sharing.
The actuarial value of the qualified prescription drug coverage in the region for a part D eligible individual with a national average risk profile for the factors described in section 1395w-115(c)(1)(A) of this title (as specified by the Secretary).
Information on the bid, including an actuarial certification of-
The service area for the plan.
Whether the PDP sponsor requires a modification of risk level under clause (ii) and, if so, the extent of such modification. Any such modification shall apply with respect to all prescription drug plans offered by a PDP sponsor in a PDP region. This subparagraph shall not apply to an MA-PD plan.
A modification of risk level under this clause may consist of one or more of the following:
An equal percentage point increase in the percents applied under subparagraphs (B)(i), (B)(ii)(I), (C)(i), and (C)(ii)(I) of section 1395w-115(e)(2) of this title. In no case shall the application of previous sentence prevent the application of a higher percentage under section 1395w-115(e)(2)(B)(iii)1 of this title.
An equal percentage point increase in the percents applied under subparagraphs (B)(ii)(II) and (C)(ii)(II) of section 1395w-115(e)(2) of this title.
A decrease in the threshold risk percentages specified in section 1395w-115(e)(3)(C) of this title.
Such other information as the Secretary may require to carry out this part.
The Secretary shall establish requirements for information submission under this subsection in a manner that promotes the offering of such plans in more than one PDP region (including all regions) through the filing of consolidated information.
For purposes of this part, the Secretary shall establish processes and methods for determining the actuarial valuation of prescription drug coverage, including-
Such processes and methods for determining actuarial valuation shall take into account the effect that providing alternative prescription drug coverage (rather than standard prescription drug coverage) has on drug utilization.
PDP sponsors and MA organizations are responsible for the preparation and submission of actuarial valuations required under this part for prescription drug plans and MA-PD plans they offer.
Under the processes and methods established under paragraph (1), PDP sponsors offering prescription drug plans and MA organizations offering MA-PD plans may use actuarial opinions certified by independent, qualified actuaries to establish actuarial values.
The Secretary shall review the information filed under subsection (b) for the purpose of conducting negotiations under paragraph (2).
Subject to subsection (i), in exercising the authority under paragraph (1), the Secretary-
Paragraph (5)(C) of section 1395w-24(a) of this title shall apply with respect to bids submitted by a PDP sponsor under subsection (b) in the same manner as such paragraph applies to bids submitted by an MA organization under such section 1395w-24(a) of this title.
After review and negotiation under subsection (d), the Secretary shall approve or disapprove the prescription drug plan.
The Secretary may approve a prescription drug plan only if the following requirements are met:
The plan and the PDP sponsor offering the plan comply with the requirements under this part, including the provision of qualified prescription drug coverage.
The Secretary determines that the plan and PDP sponsor meet the requirements under this part relating to actuarial determinations, including such requirements under section 1395w-102(c) of this title.
The Secretary determines that the portion of the bid submitted under subsection (b) that is attributable to basic prescription drug coverage is supported by the actuarial bases provided under such subsection and reasonably and equitably reflects the revenue requirements (as used for purposes of section 300e-1(8)(C) of this title) for benefits provided under that plan, less the sum (determined on a monthly per capita basis) of the actuarial value of the reinsurance payments under section 1395w-115(b) of this title.
The Secretary determines that the portion of the bid submitted under subsection (b) that is attributable to supplemental prescription drug coverage pursuant to section 1395w-102(a)(2) of this title is supported by the actuarial bases provided under such subsection and reasonably and equitably reflects the revenue requirements (as used for purposes of section 300e-1(8)(C) of this title) for such coverage under the plan.
The Secretary does not find that the design of the plan and its benefits (including any formulary and tiered formulary structure) are likely to substantially discourage enrollment by certain part D eligible individuals under the plan.
The Secretary may not find that the design of categories and classes within a formulary violates clause (i) if such categories and classes are consistent with guidelines (if any) for such categories and classes established by the United States Pharmacopeia.
The Secretary may only approve a limited risk plan (as defined in paragraph (4)(A)) for a PDP region if the access requirements under section 1395w-103(a) of this title would not be met for the region but for the approval of such a plan (or a fallback prescription drug plan under subsection (g)).
The following rules shall apply with respect to the approval of a limited risk plan in a PDP region:
Only the minimum number of such plans may be approved in order to meet the access requirements under section 1395w-103(a) of this title.
The Secretary shall provide priority in approval for those plans bearing the highest level of risk (as computed by the Secretary), but the Secretary may take into account the level of the bids submitted by such plans.
In no case may the Secretary approve a limited risk plan under which the modification of risk level provides for no (or a de minimis) level of financial risk.
There shall be no limit on the number of full risk plans that are approved under subsection (e).
For purposes of this subsection:
The term "limited risk plan" means a prescription drug plan that provides basic prescription drug coverage and for which the PDP sponsor includes a modification of risk level described in subparagraph (E) of subsection (b)(2) in its bid submitted for the plan under such subsection. Such term does not include a fallback prescription drug plan.
The term "full risk plan" means a prescription drug plan that is not a limited risk plan or a fallback prescription drug plan.
Separate from the bidding process under subsection (b), the Secretary shall provide for a process for the solicitation of bids from eligible fallback entities (as defined in paragraph (2)) for the offering in all fallback service areas (as defined in paragraph (3)) in one or more PDP regions of a fallback prescription drug plan (as defined in paragraph (4)) during the contract period specified in paragraph (5).
Except as provided in this subparagraph, the provisions of subsection (e) shall apply with respect to the approval or disapproval of fallback prescription drug plans. The Secretary shall enter into contracts under this subsection with eligible fallback entities for the offering of fallback prescription drug plans so approved in fallback service areas.
With respect to all fallback service areas in any PDP region for a contract period, the Secretary shall approve the offering of only 1 fallback prescription drug plan.
Competitive procedures (as defined in section 132 of title 41) shall be used to enter into a contract under this subsection. The provisions of subsection (d) of section 1395kk-1 of this title shall apply to a contract under this section in the same manner as they apply to a contract under such section.
The Secretary shall approve a fallback prescription drug plan for a PDP region in a manner so that, if there are any fallback service areas in the region for a year, the fallback prescription drug plan is offered at the same time as prescription drug plans would otherwise be offered.
The Secretary shall not enter into a contract with a single fallback entity for the offering of fallback plans throughout the United States.
For purposes of this section, the term "eligible fallback entity" means, with respect to all fallback service areas in a PDP region for a contract period, an entity that-
For purposes of subparagraph (B), an entity shall be treated as submitting a bid with respect to a prescription drug plan if the entity is acting as a subcontractor of a PDP sponsor that is offering such a plan. The previous sentence shall not apply to entities that are subcontractors of an MA organization except insofar as such organization is acting as a PDP sponsor with respect to a prescription drug plan.
For purposes of this subsection, the term "fallback service area" means, for a PDP region with respect to a year, any area within such region for which the Secretary determines before the beginning of the year that the access requirements of the first sentence of section 1395w-103(a) of this title will not be met for part D eligible individuals residing in the area for the year.
For purposes of this part, the term "fallback prescription drug plan" means a prescription drug plan that-
A contract entered into under this subsection shall provide for-
The performance measures established by the Secretary pursuant to subparagraph (A)(ii) shall include at least measures for each of the following:
The entity contains costs to the Medicare Prescription Drug Account and to part D eligible individuals enrolled in a fallback prescription drug plan offered by the entity through mechanisms such as generic substitution and price discounts.
The entity provides such enrollees with quality programs that avoid adverse drug reactions and overutilization and reduce medical errors.
The entity provides timely and accurate delivery of services and pharmacy and beneficiary support services.
The entity provides efficient and effective benefit administration and claims adjudication.
Except as provided in section 1395w-113(b) of this title (relating to late enrollment penalty) and subject to section 1395w-114 of this title (relating to low-income assistance), the monthly beneficiary premium to be charged under a fallback prescription drug plan offered in all fallback service areas in a PDP region shall be uniform and shall be equal to 25.5 percent (or, for 2030 and each subsequent year, the percent specified under section 1395w-113(a)(9) of this title) of an amount equal to the Secretary's estimate of the average monthly per capita actuarial cost, including administrative expenses, under the fallback prescription drug plan of providing coverage in the region, as calculated by the Chief Actuary of the Centers for Medicare & Medicaid Services. In calculating such administrative expenses, the Chief Actuary shall use a factor that is based on similar expenses of prescription drug plans that are not fallback prescription drug plans.
Except as may be appropriate to carry out this section, the terms and conditions of contracts with eligible fallback entities offering fallback prescription drug plans under this subsection shall be the same as the terms and conditions of contracts under this part for prescription drug plans.
Subject to clause (ii), a contract approved for a fallback prescription drug plan for fallback service areas for a PDP region under this section shall be for a period of 3 years (except as may be renewed after a subsequent bidding process).
A fallback prescription drug plan may be offered under a contract in an area for a year only if that area is a fallback service area for that year.
An eligible fallback entity with a contract under this subsection may not engage in any marketing or branding of a fallback prescription drug plan.
The Secretary shall submit to Congress an annual report that describes instances in which limited risk plans and fallback prescription drug plans were offered under subsections (f) and (g). The Secretary shall include in such report such recommendations as may be appropriate to limit the need for the provision of such plans and to maximize the assumption of financial risk under section subsection3 (f).
In order to promote competition under this part and in carrying out this part, the Secretary-
A PDP sponsor offering a prescription drug plan shall permit State Pharmaceutical Assistance Programs and Rx plans under sections 1395w-133 and 1395w-134 of this title to coordinate benefits with the plan and, in connection with such coordination with such a Program, not to impose fees that are unrelated to the cost of coordination.
1See References in Text note below.
2So in original. Probably should be "(v)".
3So in original.
4So in original. Probably should be "(b)(3)(I)".
42 U.S.C. § 1395w-111
EDITORIAL NOTES
REFERENCES IN TEXTSection 1395w-115(e)(2)(B)(iii) of this title, referred to in subsec. (b)(2)(E)(ii)(I), was in the original "section 1869D-15(e)(2)(B)(iii)", and was translated as reading "section 1860D-15(e)(2)(B)(iii)", meaning 1860D-15(e)(2)(B)(iii) of the Social Security Act, to reflect the probable intent of Congress, because the Social Security Act does not contain a section 1869D-15 and section 1395w-115(e)(2)(B)(iii) of this title provides for an application of a higher percentage for years 2006 and 2007.
CODIFICATIONIn subsec. (g)(1)(B)(iii), "section 132 of title 41" substituted for "section 4(5) of the Office of Federal Procurement Policy Act (41 U.S.C. 403(5))" on authority of Pub. L. 111-350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.
AMENDMENTS2022-Subsec. (g)(6). Pub. L. 117-169, §11201(d)(3)(B), inserted "(or, for 2030 and each subsequent year, the percent specified under section 1395w-113(a)(9) of this title)" after "25.5 percent". Subsec. (i)(1). Pub. L. 117-169, §11001(b)(1)(C)(i), struck out "and" at end.Subsec. (i)(2). Pub. L. 117-169, §11001(b)(1)(C)(ii), substituted ",except as provided under section 1395w-104(b)(3)(l) of this title; and" for "or institute a price structure for the reimbursement of covered part D drugs."Subsec. (i)(3). Pub. L. 117-169, §11001(b)(1)(C)(iii), added par. (3). 2010-Subsec. (d)(3). Pub. L. 111-148 added par. (3).
STATUTORY NOTES AND RELATED SUBSIDIARIES
EFFECTIVE DATE OF 2010 AMENDMENT Amendment by Pub. L. 111-148 applicable to bids submitted for contract years beginning on or after Jan. 1, 2011, see section 3209(c) of Pub. L. 111-148 set out as a note under section 1395w-24 of this title.
STUDY REGARDING REGIONAL VARIATIONS IN PRESCRIPTION DRUG SPENDING Pub. L. 108-173, title I, §107(a), Dec. 8, 2003, 117 Stat. 2169, provided that: "(1) IN GENERAL.-The Secretary [of Health and Human Services] shall conduct a study that examines variations in per capita spending for covered part D drugs under part D of title XVIII of the Social Security Act [42 U.S.C. 1395w-101 et seq.] among PDP regions and, with respect to such spending, the amount of such variation that is attributable to-"(A) price variations (described in section 1860D-15(c)(2) of such Act [42 U.S.C. 1395w-115(c)(2)] ); and"(B) differences in per capita utilization that is not taken into account in the health status risk adjustment provided under section 1860D-15(c)(1) of such Act [42 U.S.C. 1395w-115(c)(1)] ."(2) REPORT AND RECOMMENDATIONS.-Not later than January 1, 2009, the Secretary shall submit to Congress a report on the study conducted under paragraph (1). Such report shall include- "(A) information regarding the extent of geographic variation described in paragraph (1)(B);"(B) an analysis of the impact on direct subsidies under section 1860D-15(a)(1) of the Social Security Act [42 U.S.C. 1395w-115(a)(1)] in different PDP regions if such subsidies were adjusted to take into account the variation described in subparagraph (A); and"(C) recommendations regarding the appropriateness of applying an additional geographic adjustment factor under section 1860D-15(c)(2) [42 U.S.C. 1395w-115(c)(2)] that reflects some or all of the variation described in subparagraph (A)."
- Secretary
- The term "Secretary" means the Secretary of Housing and Urban Development.1See References in Text note below.
- United States
- The term "United States" means (but only for purposes of subparagraphs (A) and (B) of this paragraph) the fifty States and the District of Columbia.