Frank Pallone

“ MANUFACTURER.—The term ‘manufacturer’ means the person— “ (A) that holds the application for a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of the Public Health Service Act; or “ (B) who is responsible for setting the wholesale acquisition cost for the drug. ”

“ WORK PLAN.— (A) IN GENERAL.—Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce, the Committee on Appropriations, and the Committee on Education and Labor of the House of Representatives, a work plan including the proposed allocation of funds made available pursuant to subsection (b) for each of fiscal years 2022 through 2026 and the contents described in subparagraph (B) . ”

“ Regulations.— “ (1) IN GENERAL.—The Secretary shall, pursuant to rulemaking, specify, in accordance with paragraph (2) , the information that must be submitted under subsection (a) (4) . “ (2) INFORMATION SPECIFIED.—Information described in paragraph (1) , with respect to a selected drug, shall include information on sales of the drug (by the manufacturer of the drug or by another entity under license or other agreement with the manufacturer, with respect to the sales of such drug, regardless of the name under which the drug is sold) in any foreign country that is part of the AIM price. ”

“ DETERMINATION OF INFLATION-ADJUSTED PAYMENT AMOUNT.—The inflation-adjusted payment amount determined under this subparagraph for a part B rebatable drug for a calendar quarter is— “ (i) the payment amount for the billing and payment code for such drug in the payment amount benchmark quarter (as defined in subparagraph (D) ) ; increased by “ (ii) the percentage by which the rebate period CPI–U (as defined in subparagraph (F) ) for the calendar quarter exceeds the benchmark period CPI–U (as defined in subparagraph (E) ) . ”

“ NOTIFICATION.—If a third party with a contract under subsection (d) (3) determines that the manufacturer is not in compliance with such agreement, the third party shall notify the Secretary of such noncompliance for appropriate enforcement under subsection (e) . “ (3) COLLECTION OF DATA FROM PRESCRIPTION DRUG PLANS AND MA–PD PLANS.—The Secretary may collect appropriate data from prescription drug plans and MA–PD plans in a timeframe that allows for discounted prices to be provided for applicable drugs under this section. ”

“ In considering information described in subparagraph (C) , the Secretary shall not use evidence or findings from comparative clinical effectiveness research in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill. Nothing in the previous sentence shall affect the application or consideration of an AIM price for a selected drug. ”

“ HEALTH RESOURCES AND SERVICES ADMINISTRATION. The entirety of the funds made available pursuant to section 521 (c) (5) shall be for the Administrator of the Health Resources and Services Administration, pursuant to applicable authorities in titles III, VII, and VIII of the Public Health Service Act (42 U.S.C. 241 et seq.) , to carry out activities that increase the availability and capacity of the behavioral health workforce. Such activities shall include providing loan repayment assistance for substance use disorder treatment providers. ”

“ FORMAT.—In developing the format in which reports will be publicly posted under paragraph (1) , the Secretary shall consult with stakeholders, including beneficiary groups, and shall seek feedback from consumer advocates and readability experts on the format and presentation of the content of such reports to ensure that such reports are— “ (A) user-friendly to the public; and “ (B) written in plain language that consumers can readily understand. ”

“ Eligible Entity.—In this section, the term ‘eligible entity’ means an entity receiving funding under— “ (1) the Small Business Innovation Research program of the National Institutes of Health; or “ (2) the Small Business Technology Transfer program of the National Institutes of Health. “ (c) Use Of Funds.—An eligible entity shall use the funds received through such grant or contract to support— “ (1) the Commercialization Readiness Pilot program of the National Institutes of Health; “ (2) the Innovation Corps program of the National Institutes of Health ”

“ The many involved in Hrant Dink's
killing, from members of the gendarmerie to extremist nationalists,
have been charged or imprisoned for their actions, but it has become
apparent that Istanbul and Trabzon's security departments had
information that Hrant Dink would be killed, but failed in their duty
to protect him. ”

“ False Information.—Any manufacturer that submits a report for a drug as required by this section that knowingly provides false information in such report is subject to a civil monetary penalty in an amount not to exceed $100,000 for each item of false information. “ (g) Public Posting.— “ (1) IN GENERAL.—Subject to paragraph (4) , the Secretary shall post each report submitted under subsection (b) on the public website of the Department of Health and Human Services the day the price increase of a qualifying drug is scheduled to go into effect. ”

“ IN GENERAL.—The Secretary shall develop and use a consistent methodology for negotiations under subsection (a) that, in accordance with paragraph (2) and subject to paragraph (3) , achieves the lowest maximum fair price for each selected drug while appropriately rewarding innovation. ”

“ At a minimum, the contract with a third party under the preceding sentence shall require that the third party— “ (A) receive and transmit information between the Secretary, manufacturers, and other individuals or entities the Secretary determines appropriate; “ (B) receive, distribute, or facilitate the distribution of funds of manufacturers to appropriate individuals or entities in order to meet the obligations of manufacturers under agreements under this section ”

“ Such funds shall be in addition to any funds which are otherwise available to carry out such programs and activities. (b) Opioid Epidemic Response Fund.— (1) ESTABLISHMENT OF ACCOUNT.—There is established in the Treasury an account, to be known as the Opioid Epidemic Response Fund (referred to in this section as the “Fund”) , for purposes of funding the programs and activities described in subsection (c) . ”

“ APPLICATION TO RETIREE AND CERTAIN SMALL GROUP HEALTH PLANS.—Section 9831 (a) (2) of the Internal Revenue Code of 1986 is amended by inserting “other than with respect to section 9826,” before “any group health plan”. ”