Walden of Oregon Part B Amendment No. 1

Elijah E. Cummings Lower Drug Costs Now Act This bill establishes several programs and requirements relating to the prices of prescription drugs, health care coverage and costs, and public health. TITLE I--LOWERING PRICES THROUGH FAIR DRUG PRICE NEGOTIATION The bill requires the Department of Health and Human Services (HHS) to negotiate prices for certain drugs. (Under current law, HHS may not negotiate the prices of covered drugs under the Medicare prescription drug benefit.) Specifically, HHS must negotiate maximum prices for (1) insulin products; (2) with respect to 2023, at least 25 single-source, brand-name drugs that do not have generic competition and that are among either the 125 drugs that account for the greatest national spending or the 125 drugs that account for the greatest spending under the Medicare prescription drug benefit and Medicare Advantage (MA); (3) beginning in 2024, at least 50 such single-source, brand-name drugs; and (4) newly approved single-source, brand-name drugs that meet or exceed a specified price threshold and that HHS determines are likely to meet the spending criteria. The negotiated prices must be offered under Medicare and MA and may also be offered under private health insurance unless the insurer opts out. The negotiated maximum price may not exceed (1) 120% of the average price in Australia, Canada, France, Germany, Japan, and the United Kingdom; or (2) if such information is not available, 85% of the U.S. average manufacturer price. Drug manufacturers that fail to comply with the bill's negotiation requirements are subject to civil and tax penalties. TITLE II--MEDICARE PARTS B AND D PRESCRIPTION DRUG INFLATION REBATES The bill also requires drug manufacturers, subject to civil penalties, to issue rebates to the Centers for Medicare & Medicaid Services (CMS) for covered drugs under Medicare that cost $100 or more and for which the average manufacturer price increases faster than inflation. TITLE III--PART D IMPROVEMENTS AND MAXIMUM OUT-OF-POCKET CAP FOR MEDICARE BENEFICIARIES The bill reduces the annual out-of-pocket spending threshold, and eliminates beneficiary cost-sharing above this threshold, under the Medicare prescription drug benefit. Additionally, prescription drug plan sponsors must allow certain beneficiaries to make coinsurance payments in periodic installments, in accordance with CMS requirements. TITLE IV--DRUG PRICE TRANSPARENCY Drug manufacturers must report, subject to civil penalties, specified information for certain drugs that cost $100 or more and that are covered under Medicare or Medicaid, based on the rate of price or spending increases. Among other things, manufacturers must report a qualifying price increase at least 30 days before the effective date of the increase; HHS must publish the information on its website the day the increase takes effect. TITLE V--PROGRAM IMPROVEMENTS FOR MEDICARE LOW-INCOME BENEFICIARIES The bill expands eligibility for certain premium and cost-sharing subsidies for low-income beneficiaries under the Medicare prescription drug benefit. For example, the bill (1) raises the maximum allowable income for beneficiaries to qualify, and (2) allows certain residents of U.S. territories to automatically qualify. TITLE VI--PROVIDING FOR DENTAL, VISION, AND HEARING COVERAGE UNDER THE MEDICARE PROGRAM The bill also expands Medicare coverage to include (1) dentures and dental and oral health services, including basic and major treatments (as determined by the CMS) as well as specified preventive and screening services; (2) hearing aids and hearing rehabilitation and treatment services; and (3) eyeglasses, contact lenses, and vision services, including routine eye examinations and contact lens fittings. TITLE VII--NIH, FDA, AND OPIOIDS FUNDING The bill provides additional funds for several public health programs. Among other things, the bill (1) provides specified funds for innovation projects at the National Institutes of Healt…