42 USC 1395w-112 - Requirements for and contracts with prescription drug plan (PDP) sponsors

U.S Code last checked for updates: Feb 21, 2025

§ 1395w–112.

Requirements for and contracts with prescription drug plan (PDP) sponsors

(a)

General requirements

Each PDP sponsor of a prescription drug plan shall meet the following requirements:

(1)

Licensure

(2)

Assumption of financial risk for unsubsidized coverage

(A)

In general

(B)

Reinsurance permitted

(3)

Solvency for unlicensed sponsors

(b)

Contract requirements

(1)

In general

(2)

Limitation on entities offering fallback prescription drug plans

The Secretary shall not enter into a contract with a PDP sponsor for the offering of a prescription drug plan (other than a fallback prescription drug plan) in a PDP region for a year if the sponsor—

(A)

submitted a bid under section 1395w–111(g) of this title for such year (as the first year of a contract period under such section) to offer a fallback prescription drug plan in any PDP region;

(B)

offers a fallback prescription drug plan in any PDP region during the year; or

(C)

offered a fallback prescription drug plan in that PDP region during the previous year.

For purposes of this paragraph, an entity shall be treated as submitting a bid with respect to a prescription drug plan or offering a fallback 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.

(3)

Incorporation of certain medicare advantage contract requirements

Except as otherwise provided, the following provisions of section 1395w–27 of this title shall apply to contracts under this section in the same manner as they apply to contracts under section 1395w–27(a) of this title:

(A)

Minimum enrollment

Paragraphs (1) and (3) of section 1395w–27(b) of this title, except that—

(i)

the Secretary may increase the minimum number of enrollees required under such paragraph (1) as the Secretary determines appropriate; and

(ii)

the requirement of such paragraph (1) shall be waived during the first contract year with respect to an organization in a region.

(B)

Contract period and effectiveness

(C)

Protections against fraud and beneficiary protections

(D)

Additional contract terms

(i)

may be used for the purposes of carrying out this part, improving public health through research on the utilization, safety, effectiveness, quality, and efficiency of health care services (as the Secretary determines appropriate), or carrying out part E of subchapter XI; and

(ii)

shall be made available to Congressional 1

 So in original. Probably should not be capitalized.

support agencies (in accordance with their obligations to support Congress as set out in their authorizing statutes) for the purposes of conducting Congressional 1 oversight, monitoring, making recommendations, and analysis of the program under this subchapter.

(E)

Intermediate sanctions

(F)

Procedures for termination

(4)

Prompt payment of clean claims

(A)

Prompt payment

(i)

In general

(ii)

Clean claim defined

(iii)

Date of receipt of claim

In this paragraph, a claim is considered to have been received—

(I)

with respect to claims submitted electronically, on the date on which the claim is transferred; and

(II)

with respect to claims submitted otherwise, on the 5th day after the postmark date of the claim or the date specified in the time stamp of the transmission.

(B)

Applicable number of calendar days defined

In this paragraph, the term “applicable number of calendar days” means—

(i)

with respect to claims submitted electronically, 14 days; and

(ii)

with respect to claims submitted otherwise, 30 days.

(C)

Interest payment

(i)

In general

(ii)

Authority not to charge interest

(D)

Procedures involving claims

(i)

Claim deemed to be clean

A claim is deemed to be a clean claim if the PDP sponsor involved does not provide notice to the claimant of any deficiency in the claim—

(I)

with respect to claims submitted electronically, within 10 days after the date on which the claim is received; and

(II)

with respect to claims submitted otherwise, within 15 days after the date on which the claim is received.

(ii)

Claim determined to not be a clean claim

(I)

In general

(II)

Determination after submission of additional information

(iii)

Obligation to pay

(iv)

Date of payment of claim

Payment of a clean claim under such subparagraph is considered to have been made on the date on which—

(I)

with respect to claims paid electronically, the payment is transferred; and

(II)

with respect to claims paid otherwise, the payment is submitted to the United States Postal Service or common carrier for delivery.

(E)

Electronic transfer of funds

(F)

Protecting the rights of claimants

(i)

In general

(ii)

Anti-retaliation

(G)

Rule of construction

(5)

Submission of claims by pharmacies located in or contracting with long-term care facilities

(6)

Regular update of prescription drug pricing standard

(7)

Suspension of payments pending investigation of credible allegations of fraud by pharmacies

(A)

In general

(B)

Rule of construction

(8)

Provision of information related to maximum fair prices

(c)

Waiver of certain requirements to expand choice

(1)

Authorizing waiver

(A)

In general

(B)

Application of regional plan waiver rule

(2)

Grounds for approval

(A)

In general

The grounds for approval under this paragraph are—

(i)

subject to subparagraph (B), the grounds for approval described in subparagraphs (B), (C), and (D) of section 1395w–25(a)(2) of this title; and

(ii)

the application by a State of any grounds other than those required under Federal law.

(B)

Special rules

In applying subparagraph (A)(i)—

(i)

the ground of approval described in section 1395w–25(a)(2)(B) of this title is deemed to have been met if the State does not have a licensing process in effect with respect to the PDP sponsor; and

(ii)

for plan years beginning before January 1, 2008, if the State does have such a licensing process in effect, such ground for approval described in such section is deemed to have been met upon submission of an application described in such section.

(3)

Application of waiver procedures

(4)

References to certain provisions

In applying provisions of section 1395w–25(a)(2) of this title under paragraphs (2) and (3) of this subsection to prescription drug plans and PDP sponsors—

(A)

any reference to a waiver application under section 1395w–25 of this title shall be treated as a reference to a waiver application under paragraph (1)(A) of this subsection; and

(B)

any reference to solvency standards shall be treated as a reference to solvency standards established under subsection (d) of this section.

(d)

Solvency standards for non-licensed entities

(1)

Establishment and publication

(2)

Compliance with standards

(e)

Licensure does not substitute for or constitute certification

(f)

Periodic review and revision of standards

(1)

In general

(2)

Prohibition of midyear implementation of significant new regulatory requirements

(g)

Prohibition of State imposition of premium taxes; relation to State laws

(Aug. 14, 1935, ch. 531, title XVIII, § 1860D–12, as added Pub. L. 108–173, title I, § 101(a)(2), Dec. 8, 2003, 117 Stat. 2099; amended Pub. L. 110–275, title I, §§ 171(a), 172(a)(1), 173(a), 181, July 15, 2008, 122 Stat. 2578, 2580–2582; Pub. L. 115–271, title II, § 2008(a), Oct. 24, 2018, 132 Stat. 3931; Pub. L. 117–169, title I, § 11001(b)(1)(F)(i), (H)(i), Aug. 16, 2022, 136 Stat. 1852, 1853.)

cite as: 42 USC 1395w-112