H.R. 6166 — Lowering Drug Costs for American Families Act

This section expands the Medicare Drug Price Negotiation Program by increasing the number of selected drugs subject to price negotiation to 50 annually (from 20), as specified in SSA §1192(a)(4). The section further expands the definition of maximum fair price eligible individuals under SSA §1191(c)(2) to include participants, beneficiaries, or enrollees in group health plans or group or individual health insurance coverage (as defined in PHSA §2791) that have (or are treated as having) an agreement with the Secretary under new SSA §1197 with respect to a selected drug; applies administrative procedures under SSA §1196(a)(3) to such individuals; establishes SSA §1197 to automatically treat the Secretary as having such an agreement with those plans and coverage for covered selected drugs during a price applicability period unless the plan or issuer affirmatively opts out via a Secretary-specified process (with opt-outs published publicly); and applies program requirements (including maximum fair prices) to those plans and enrollees in the same manner as to Medicare prescription drug plans and Medicare Advantage prescription drug plans under new PHSA §2799A–11. (As background, the program—established by the Inflation Reduction Act in SSA Part E, title XI (42 U.S.C. 1320f et seq.)—requires manufacturers of high-cost, single-source Part D drugs to negotiate maximum fair prices with HHS, with prices applying beginning in 2026 for initial selected drugs. Thus, this expansion subjects commercial group and individual market coverage to negotiated prices unless opted out.)

This section requires the Secretary of Health and Human Services, in negotiations under the Medicare Drug Price Negotiation Program, to consider the average international market price (i.e., the net average price, if practicable, and volume-weighted, if practicable) per unit (i.e., the lowest identifiable quantity of the drug, such as a capsule, tablet, milligram, or gram) across different dosage forms and strengths for sales of a selected drug in applicable countries (Australia, Canada, France, Germany, Japan, and the United Kingdom) with available pricing data, as computed on the date of selection. (The Medicare Drug Price Negotiation Program authorizes HHS to negotiate maximum fair prices for high-cost, single-source Medicare Part D drugs and certain Part B drugs.) The requirement applies to initial price applicability years and renegotiations beginning on or after January 1, 2028.

This section repeals Section 71203 of Public Law 119-21, restoring the Medicare Drug Price Negotiation Program (i.e., the Inflation Reduction Act of 2022 program authorizing the Department of Health and Human Services to select and negotiate "maximum fair prices" for high-cost, single-source drugs covered under Medicare Part D and Part B) to its pre-Public Law 119-21 form.

This section revises the prescription drug inflation rebate programs under Medicare Part B (i.e., for certain physician-administered drugs) and Part D (i.e., for drugs covered under the Medicare prescription drug benefit) to include, in the calculation of total units, units of rebatable drugs furnished in the commercial market (excluding Medicare, Medicaid, and other specified units). (The rebate programs, enacted under the Inflation Reduction Act, require manufacturers to remit rebates to Medicare when a drug's price rises faster than inflation, with rebate amounts scaled to total units dispensed.) **(a) Part B drugs**—Amends section 1847A(i) of the Social Security Act (1) to replace references to "units" with "billing units" in specified provisions; (2) to base commercial market payment amounts on rates that would apply if the drugs were furnished to Medicare enrollees; and (3) to calculate total billing units by subtracting Medicaid units (as reported under section 1927(b)(2)(A)) from total units reported for each National Drug Code, converting the remainder to billing units using the program's methodology. The amendments apply to calendar quarters beginning after the date of enactment. **(b) Part D rebatable drugs**—Amends section 1860D–14B by (1) basing total units on those used to calculate average manufacturer price (as reported monthly under section 1927), excluding Medicaid units, Part B rebate units under section 1847A(i), and—beginning with plan year 2026—units discounted under the 340B drug pricing program; (2) revising processes for manufacturer revisions to average manufacturer price reports; and (3) directing use of section 1927 manufacturer and State data for implementation. The amendments apply to applicable periods (generally, 12-month spans beginning January 1) beginning after the date of enactment.

This section establishes, for plan years beginning in 2027 under the Public Health Service Act (PHSA), Employee Retirement Income Security Act (ERISA), and parallel requirements for group health plans and group or individual health insurance coverage, (1) requirements for issuers in the individual and small group markets to cover the essential health benefits package; (2) an annual out-of-pocket limit on all cost-sharing (including prescription drugs) equal to the amount under ACA §1302(c)(1) for 2014 ($6,350 self-only; $12,700 other than self-only), increased for 2027 by the premium adjustment percentage and subject to annual adjustments thereafter based on average per capita premium growth (rounded to the next lowest multiple of $50); and (3) a separate annual out-of-pocket limit on prescription drug cost-sharing of $2,000 self-only ($4,000 other than self-only), subject to annual adjustments thereafter based on premium growth (rounded to the next lowest multiple of $50). Issuers offering coverage in specified metal levels must also offer child-only plans for individuals under age 21; stand-alone dental plans are exempt. (Thus, enrollees face capped annual spending for essential health benefits and prescription drugs, where cost-sharing includes deductibles, coinsurance, copayments, and qualified medical expenses but excludes premiums, balance billing, and non-covered services.) This section sunsets the cost-sharing provisions added to PHSA §2707 by §101 for plan years beginning on or after January 1, 2027.

This section requires group health plans and health insurance issuers offering group or individual health insurance coverage to cover selected insulin products without any deductible and with cost-sharing not exceeding the lesser of $35 or 25% of the negotiated price net of all price concessions per 30-day supply, for plan years beginning on or after January 1, 2027. Selected insulin products means at least one of each dosage form (e.g., vial, pump, inhaler) and type (e.g., rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, premixed) of insulin licensed under PHSA §351, as selected by the plan or issuer; such cost-sharing counts toward deductibles and out-of-pocket maximums but does not apply to non-selected insulin products or require coverage by out-of-network providers (who may face higher cost-sharing).