2020 US Code
Title 42 - The Public Health and Welfare
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
Sec. 1395w-153 - Condition for coverage of drugs under this part

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Citation 42 U.S.C. § 1395w-153 (2020)
Section Name §1395w–153. Condition for coverage of drugs under this part
Section Text (a) In general

In 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 the Medicare coverage gap discount program under section 1395w–114a of this title;

(2) have entered into and have in effect an agreement described in subsection (b) of such section 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 such section.

(b) Effective date

Subsection (a) shall apply to covered part D drugs dispensed under this part on or after January 1, 2011.

(c) Authorizing coverage for drugs not covered under agreements

Subsection (a) shall not apply to the dispensing of a covered part D drug if—

(1) the Secretary has made a determination that the availability of the drug is essential to the health of beneficiaries under this part; or

(2) the Secretary determines that in the period beginning on January 1, 2011, and 1 December 31, 2011, there were extenuating circumstances.

(d) Definition of manufacturer

In this section, the term "manufacturer" has the meaning given such term in section 1395w–114a(g)(5) of this title.

Source Credit

(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.)

Editorial Notes AMENDMENTS

2010—Subsec. (b). Pub. L. 111–152, §1101(b)(1)(A), substituted "January 1, 2011" for "July 1, 2010".

Subsec. (c)(2). Pub. L. 111–152, §1101(b)(1)(B), substituted "January 1, 2011, and December 31, 2011," for "July 1, 2010, and ending on December 31, 2010,".

Footnotes

1 So in original. Probably should be followed by "ending on".

Publication Title United States Code, 2018 Edition, Supplement 2, Title 42 - THE PUBLIC HEALTH AND WELFARE
Category Bills and Statutes
Collection United States Code
SuDoc Class Number Y 1.2/5:
Contained Within Title 42 - THE PUBLIC HEALTH AND WELFARE
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
Sec. 1395w-153 - Condition for coverage of drugs under this part
Contains section 1395w-153
Date 2020
Laws In Effect As Of Date January 13, 2021
Positive Law No
Disposition standard
Statutes at Large References 124 Stat. 461, 1037
Public Law References Public Law 111-148, Public Law 111-152
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