S. 891 — Bipartisan Health Care Act

This section requires state Medicaid and Children's Health Insurance Program (CHIP) plans to adopt a streamlined enrollment process for eligible out-of-state providers to furnish items and services to, or order, prescribe, refer, or certify eligibility for such items and services for, qualifying individuals (i.e., enrollees under 21 years of age), limiting state screening and enrollment requirements to minimum necessary information such as provider name and National Provider Identifier and providing 5-year enrollment periods unless the provider is terminated or excluded. Eligible out-of-state providers are those located in another state (excluding territories), determined to have limited risk of fraud, waste, and abuse and enrolled as such in Medicare or their home state's Medicaid or CHIP program, and without specified exclusions or terminations from federal health care programs or state plans. The section includes conforming amendments to existing Medicaid and CHIP provider screening requirements and takes effect 3 years after enactment.

This section increases transparency requirements for home and community-based services (HCBS) under Medicaid section 1915(c) waivers by requiring states to report to the Secretary, not less frequently than annually, specified information on waiver waitlists (including screening practices, waitlist size, and average wait times for new enrollees) and, for homemaker services, home health aide services, personal care services, and habilitation services furnished under such waivers (or under sections 1915(i), (j), or (k)), average time from approval to service delivery and percentage of authorized hours provided for new recipients and overall (using statistically valid sampling where applicable), with such information for the specified services required on or after July 9, 2027; requires the Secretary to make all such information publicly available on the Centers for Medicare & Medicaid Services website on or after enactment; and makes conforming reporting amendments to sections 1915(i), (j), and (k). (HCBS waivers enable states to provide long-term care services in community settings, rather than institutions, to elderly and disabled individuals who qualify for institutional-level care, often amid substantial waitlists.) This section further establishes a demonstration program under section 1915(c) under which, not later than 24 months after planning grants are awarded, the Secretary may approve standalone waivers for up to five states (selected for geographic diversity, with preferences for states with higher rural populations and greater progress rebalancing long-term services and supports toward HCBS) to include, as state plan medical assistance for a three-year period, payment for part or all of the non-room-and-board costs of Secretary-approved HCBS provided via a written plan of care to eligible individuals.

This section removes the upper age limit of less than 65 years from Medicaid's optional eligibility group for working individuals with disabilities under section 1902(a)(10)(A)(ii)(XV) of the Social Security Act (i.e., the Medicaid buy-in program, which enables states to provide coverage to employed disabled adults who exceed standard Medicaid income limits by paying a premium or cost-sharing). (As background, the program—currently available to those ages 16 through 64—promotes employment among working-age disabled adults by preserving Medicaid coverage.) It makes a conforming change to the definition of such working individuals in section 1905(v)(1)(A). States already offering buy-in coverage to individuals in this group as of enactment have until January 1, 2027, to conform to the amended requirements.

This section requires state Medicaid plans, beginning January 1, 2028, to treat active duty relocated individuals (i.e., certain active duty service members, recent retirees within 12 months, or their dependents who relocate to a new state due to military service and were enrolled in Medicaid or on a home and community-based services (HCBS) waiting list) as residents of the new military service relocation state for eligibility purposes unless they elect otherwise; maintain their prior HCBS waiting list status (i.e., for states with enrollment caps under Medicaid demonstration waivers or HCBS waivers) until an eligibility decision and fair hearing opportunity or voluntary removal; and cover medical assistance furnished in the new state per Secretary guidance. (Thus, the changes promote continuity of Medicaid coverage and HCBS access for military families.) This section also appropriates $1 million annually for FY2025 through FY2029 to the Secretary of Health and Human Services for implementation.

This section requires state Medicaid plans, beginning January 1, 2026, to establish a process to regularly obtain address information for enrollees from reliable data sources (as described in 42 C.F.R. § 435.919(f)(1)(iii) or successor regulation) and to act on any identified changes (applies only to the 50 states and District of Columbia). It applies the same requirement to state CHIP (Children's Health Insurance Program) plans. The section further requires Medicaid managed care contracts, beginning January 1, 2026, to mandate that entities transmit to the state any enrollee address information provided directly by or verified directly with the enrollee.

This section requires state Medicaid plans, beginning January 1, 2027, to screen enrolled providers and suppliers against the Death Master File (i.e., the Social Security Administration database of deceased persons, as defined in sec. 203(d) of the Bipartisan Budget Act of 2013) upon enrollment, reenrollment, or revalidation and not less frequently than quarterly thereafter to determine whether such providers or suppliers are deceased. (Thus, states must deactivate deceased providers' enrollments to prevent improper payments.)

This section requires state Medicaid plans to provide for compliance with specified eligibility verification requirements using the Death Master File, applicable only to the 50 states and the District of Columbia. Beginning January 1, 2026, states must (1) screen the Death Master File quarterly to identify deceased enrollees under the state plan (or waiver); (2) disenroll such individuals, treat Death Master File data as factual confirmation of death, and discontinue payments for medical assistance on their behalf (except for items or services furnished prior to death); and (3) immediately reenroll, retroactive to the disenrollment date, any individual erroneously identified as deceased. Nothing in these requirements precludes states from using other electronic data sources to identify deceased beneficiaries, provided they also comply with these provisions.

This section delays, to January 1, 2026, state compliance with Medicaid and CHIP requirements to arrange health screenings, referrals, follow-up care, and case management services for eligible juveniles (i.e., those under the jurisdiction of a state juvenile justice system who were Medicaid- or CHIP-enrolled at any time in the prior 120 days) incarcerated in public institutions and transitioning to the community. (Previously, compliance was required by January 1, 2025.) It further (1) excludes individuals in federal custody (including federal prison inmates) from those requirements under Medicaid and CHIP, with the exclusion effective retroactively as if enacted on December 29, 2022; and (2) requires each state to submit to the Secretary of Health and Human Services, by June 30, 2025, an interim work plan describing progress toward compliance, consistent with Centers for Medicare & Medicaid Services guidance issued July 23, 2024.

This section directs each state (as defined in section 1101(a)(1) of the Social Security Act for titles XIX and XXI, i.e., Medicaid and CHIP) to conduct a study not later than 24 months after enactment and every five years thereafter on the costs of providing maternity, labor, and delivery services in applicable hospitals, and to submit the results to the Secretary of Health and Human Services (HHS). Applicable hospitals are those that either (1) provide labor and delivery services with more than 50% of births (in the most recent year for which data are available) financed by Medicaid or CHIP or (2) are rural (as defined by the Federal Office of Rural Health Policy), provide such services, and averaged fewer than 300 births per year over the most recent two years for which data are available. State studies must include (to the extent practicable) cost estimates for current and recently closed services, analyses of geographic, demographic, and economic factors affecting costs, payment amounts under Medicare, Medicaid, CHIP, and private insurance (including managed care), comparative payment rate analyses, and evaluations of anticipated expenditure or reimbursement changes over the next three years. HHS must issue a public report on each state's study within 12 months of submission and, not later than three years after enactment, submit to Congress and publicly release a report analyzing the initial round of state studies with recommendations for improving data collection. This section appropriates $10 million for FY2025 to HHS for grants and technical assistance to hospitals described in (2) above to compile study data ($10 million available until expended) and an additional $3 million for FY2025 for implementation (available until expended).

This section modifies Medicaid disproportionate share hospital (DSH) allotments, which provide federal funding to states for payments to hospitals serving high shares of low-income patients. Specifically, it (1) extends Tennessee's DSH allotment to FY2026 (from FY2025) and the first quarter of FY2027 at $13,275,000; and (2) delays the start of statutory DSH allotment reductions under SSA section 1923(f)(7) to the period beginning January 1, 2027, and ending September 30, 2027, and FY2028 (from April 1, 2025, through FY2027), and extends the related provision in paragraph (8) to FY2028 (from FY2027). (Thus, states retain higher DSH allotments during the delayed period.)

This section revises limitations on Medicaid disproportionate share hospital (DSH) payment adjustments under SSA section 1923(g) attributable to uncompensated care costs (UCC). (As background, DSH payments provide federal matching funds to eligible hospitals serving high volumes of Medicaid and uninsured patients to offset uncompensated care; the UCC limit caps such payments at the amount by which a hospital's costs for specified services exceed related payments received.) Specifically, the amendments to subsection (g)(1) (1) eliminate the prior exclusion of certain hospitals from the UCC limit; (2) expand qualifying payments subtracted from costs to include Medicare (title XVIII) payments and payments by applicable plans (as defined in SSA section 1862(b)(8)(F), i.e., certain employer-sponsored plans where Medicare is secondary payer); (3) add as qualifying individuals for UCC calculation those eligible for Medicaid (or a waiver) for whom the state plan/waiver is payor of services after Medicare or applicable plan benefits, provided the hospital's aggregate costs for such individuals exceed aggregate payments under Medicaid, Medicare, or the applicable plan for the year; (4) strike paragraph (2), which provided a temporary exception to the UCC limit (in effect as of October 1, 2021); and (5) redesignate paragraph (3) as paragraph (2) and conform references to eliminate the prior "notwithstanding" clause. (Thus, the revised UCC limit applies to all DSH-eligible hospitals, with a narrower net UCC due to additional payments subtracted but an expanded patient population potentially increasing gross costs.) The amendments apply to Medicaid state plan rate years beginning on or after the date of enactment. For rate years beginning after October 1, 2021, and before enactment, states may elect to apply unspent DSH allotments to increase prior payment adjustments consistent with the revised subsection (g), up to the state's DSH allotment under subsection (f); such states may not recoup prior payments compliant with prior law, may seek Secretary approval for retroactive state plan modifications (due before the independent certified audit deadline under subsection (j)(2)), and must report increases in their next annual report under subsection (j)(1).

This section revises Medicaid requirements for the Secretary's survey of pharmacy drug acquisition costs to determine national average drug acquisition cost benchmarks for covered outpatient drugs (i.e., the NADAC survey used by states to set pharmacy reimbursement rates). Specifically, it (1) expands the survey to require monthly vendor-conducted determinations of average acquisition costs—net of discounts, rebates, and price concessions—for both retail community pharmacies and applicable non-retail pharmacies (with separate surveys and, at the Secretary's discretion, by non-retail pharmacy type); (2) requires vendors to provide monthly updates and to differentiate data by pharmacy type (including affiliates and non-retail subtypes per specified guidance); (3) directs states to require all pharmacies receiving Medicaid-related payments, reimbursements, or concessions (directly or via pharmacy benefit managers) to respond to surveys; (4) mandates public release of survey information, including monthly response rates, non-compliant pharmacy lists, sampling details, and available price concession data; and (5) authorizes civil money penalties up to $100,000 per violation (and per non-compliant pharmacy, including chains) for refusals to respond, false information, or other non-compliance.

This section amends the Medicaid drug rebate statute to require states' contracts with pharmacy benefit managers (PBMs) or managed care and other specified entities to use transparent prescription drug pass-through pricing for covered outpatient drugs, under which (1) payments are limited to ingredient cost plus a professional dispensing fee (not less than the fee the state would pay directly under its plan), passed through entirely to dispensing pharmacies (except for waste, fraud, or abuse reductions) and consistent with specified federal regulations (with limited exceptions for 340B drugs requiring annual excess payment reporting); (2) PBM or entity administrative fees are limited to fair market value; (3) all related costs and payments (e.g., ingredient costs, dispensing fees, post-sale fees, discounts, direct and indirect remuneration) are disclosed to the state and Secretary upon request, broken down by drug; and (4) spread pricing (i.e., amounts charged exceeding amounts paid to pharmacies after administrative fees) is unallowable for federal matching payments. (Thus, this prevents PBMs from retaining differences between what they charge states or plans and what they pay pharmacies.) It also requires the Secretary to publish annual data on reported 340B excess payments by state and covered entity category (e.g., children's hospitals, federal grantees) without identifying specific entities and defines "pharmacy benefit manager."

This section extends the temporary increased payment adjustment for low-volume hospitals under Medicare's inpatient prospective payment system (IPPS) by revising specified periods in SSA section 1886(d)(12) as follows: (1) in subparagraph (B), from fiscal year 2025 (April 1-September 30) and fiscal year 2026 to fiscal year 2026 (January 1-September 30) and fiscal year 2027; (2) in subparagraph (C)(i), from fiscal years through 2024 and fiscal year 2025 (October 1-March 31) to fiscal years through 2025 and fiscal year 2026 (October 1-December 31); and (3) in subparagraph (D), from fiscal years through 2024 and fiscal year 2025 (October 1-March 31) to fiscal years through 2025 and fiscal year 2026 (October 1-December 31). (As background, the adjustment provides eligible rural hospitals with Medicare discharges of 800 or fewer annually and low volume—generally under 5,000 total discharges—a payment increase of up to 25% to offset fixed costs.) It also authorizes the Secretary to implement these changes via program instruction.

This section extends the Medicare-dependent hospital (MDH) program—under which small rural hospitals with high Medicare utilization receive enhanced inpatient prospective payments equal to the higher of a hospital-specific rate or the national standardized amount, plus a potential 5% add-on—to January 1, 2026 (from April 1, 2025). It makes conforming changes to (1) the schedule of applicable percentage increases to the standardized payment amount through FY2025 and the portion of FY2026 ending December 31, 2025 (from through FY2024 and the portion of FY2025 ending March 31, 2025); and (2) the period during which MDHs may elect to decline Medicare geographic reclassification through FY2025 and the portion of FY2026 ending December 31, 2025 (from through FY2024 and the portion of FY2025 ending March 31, 2025).

This section extends add-on payments under the Medicare ambulance fee schedule—(1) by 22.6% of the base rate for ground ambulance services furnished in rural areas; and (2) by 44.6% of the base rate for such services furnished in super rural areas—through January 1, 2027 (from April 1, 2025).

This section extends Medicare Part B incentive payments to qualifying participants in eligible alternative payment models—clinicians meeting participation thresholds in advanced alternative payment models (i.e., those bearing more than nominal financial risk or meeting other criteria under the Quality Payment Program)—by (1) extending such payments through the payment year ending with 2027 (from 2026); (2) applying a 3.53 percent rate for 2027 (in addition to the prior 1.88 percent rate); (3) shifting dates for specified payment amounts or thresholds under the statutory schedule to 2027 and 2028 (from 2026 and 2027); and (4) making conforming amendments to MIPS eligibility provisions to extend relevant dates to 2027 and 2028 (from 2026 and 2027).

This section provides a temporary 3.5375 percent increase in payments under the Medicare physician fee schedule for services furnished on or after March 15, 2025, and before January 1, 2026. It also makes a conforming amendment to include 2025 (in addition to 2024) among the years excluded from a specified update adjustment factor calculation.

This section increases specified funding for the consensus-based entity contract for health care quality measure endorsement, input, and selection to $14 million (from $11,030,000) and extends the funding period through December 31, 2025 (from March 31, 2025). (The entity, such as the National Quality Forum, synthesizes evidence, convenes stakeholders on measurement priorities, and endorses standardized performance measures used in Medicare payment and quality programs.)

This section extends funding for Medicare outreach and assistance programs for low-income beneficiaries under section 119 of the Medicare Improvements for Patients and Providers Act of 2008 (i.e., State Health Insurance Assistance Programs (SHIP), area agencies on aging, aging and disability resource centers, and coordination activities to inform older Americans about federal and state benefits) by providing the following appropriations for the period beginning April 1, 2025, and ending December 31, 2026: (1) $26.25 million for SHIP; (2) $26.25 million for area agencies on aging; (3) $7.75 million for aging and disability resource centers; and (4) $26.25 million for coordination activities. (As background, these programs provide counseling, education, and assistance to Medicare beneficiaries on plan options, low-income subsidies, and related benefits.)

This section extends multiple Medicare telehealth flexibilities through specified dates (from dates in 2025) and makes related changes to payment rules and requirements. Specifically, it (1) extends waivers of geographic restrictions and expanded originating sites for telehealth services through December 31, 2026 (from March 31, 2025); (2) extends eligibility of additional practitioners (e.g., physical therapists, occupational therapists) to furnish telehealth services through December 31, 2026 (from March 31, 2025); (3) for federally qualified health centers (FQHCs) and rural health clinics (RHCs), extends authority to serve as distant sites through December 31, 2026 (from March 31, 2025), specifies prior payment rules apply before April 1, 2025, and establishes new payment as FQHC/RHC services (with allowable costs) from April 1, 2025, through December 31, 2026 (requiring modifiers by July 1, 2025); (4) delays in-person requirements for mental health telehealth services, including those at RHCs and FQHCs, through January 1, 2027 (from April 1, 2025); (5) extends coverage of audio-only telehealth services through December 31, 2026 (from March 31, 2025); (6) extends use of telehealth for hospice eligibility recertification face-to-face encounters through December 31, 2026 (from March 31, 2025), except for specified cases (e.g., moratorium areas, enhanced oversight providers) on or after April 1, 2025; and (7) requires modifiers on claims for certain telehealth services (e.g., via virtual platforms with payment arrangements, incident-to services) beginning January 1, 2026. The Secretary of Health and Human Services may implement these changes via program instruction.

This section requires that, for face-to-face encounters conducted via telehealth on or after January 1, 2026, prior to recertification of Medicare hospice care eligibility (i.e., required before the ninth and subsequent 60-day benefit periods), any associated hospice claim include one or more modifiers or codes (aspecified by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by by

This section extends waiver flexibilities under the Acute Hospital Care at Home initiative—allowing participating hospitals to furnish acute-level hospital services in Medicare beneficiaries' homes and bill at inpatient rates—through December 31, 2029 (from March 31, 2025); renames the initiative in the section heading and text to include congressional sponsors; and authorizes the Secretary to require data submissions through hospital cost reports, surveys, medical records, or other means. The section redesignates the existing study as the "initial study," references a new subsequent study in its requirements, and requires the Secretary to conduct that study by September 30, 2028, analyzing patient selection criteria, quality metrics (e.g., readmissions, mortality, length of stay, infection rates), costs, service intensity, demographics, and outcomes between the initiative and traditional inpatient care (controlling for selection bias); post a report on the CMS website by that date; and appropriates $6 million for FY2026 to the CMS Program Management Account for these purposes.

This section establishes program integrity requirements for durable medical equipment (DME) under Medicare Part B by adding a new paragraph to Section 1834(a) of the Social Security Act. (1) Beginning January 1, 2028, DME items for which a substantial number of claims are ordered by a physician or practitioner without prior furnishing of any Medicare-covered item or service to the beneficiary during at least the prior 24 months are treated as having aberrant billing patterns for inclusion on the CMS Master List (42 CFR 414.234(b)); (2) for such listed items furnished on or after January 1, 2028, and not subject to advance coverage determinations, the Secretary may conduct prepayment claim reviews. This section applies the new requirements to prosthetic devices, orthotics, and prosthetics in the same manner. Separately, this section requires the HHS Inspector General to submit to Congress by January 1, 2026, a report assessing fraud risks for clinical diagnostic laboratory tests under Medicare Part B, including identification of high-risk tests, payment amounts and utilization data, ordering patterns from unfamiliar providers, use of certain billing modifiers, and recommended mitigation strategies such as improved detection, provider monitoring, and education.

This section directs the Secretary of Health and Human Services, not later than one year after enactment and in consultation with entities such as health information technology providers, health care providers, health insurers, language service companies, interpreter associations, certification organizations, and patient advocates, to issue guidance on best practices for telehealth services (under Medicare telehealth provisions at 42 U.S.C. 1395m(m)) for individuals with limited English proficiency. The guidance covers (1) facilitating interpreter use during telemedicine appointments, (2) accessible instructions for telecommunications systems, (3) digital patient portal access, (4) multi-person video platforms for interpretation, and (5) multilingual patient materials, communications, and instructions.

This section modifies Medicare coverage requirements for cardiac rehabilitation programs and pulmonary rehabilitation programs (i.e., supervised exercise, education, and counseling for beneficiaries with qualifying heart or lung conditions) to permit, for items and services furnished on or after April 1, 2025, and before January 1, 2027— (1) delivery on an outpatient basis in the home of a hospital outpatient using audio and video real-time communications technology (excluding audio-only); and (2) virtual presence (using audio and video real-time communications technology) of the required physician, physician assistant, nurse practitioner, or clinical nurse specialist. The section further authorizes the Secretary of Health and Human Services to implement these amendments by program instruction or otherwise.

This section directs the Secretary of Health and Human Services to revise CMS regulations by January 1, 2026, to permit, for calendar years 2026 through 2030, virtual-only participation in the Medicare Diabetes Prevention Program (MDPP) expanded model under the Center for Medicare and Medicaid Innovation (i.e., furnishes lifestyle coaching services to Medicare beneficiaries at high risk for type 2 diabetes to prevent or delay onset). Specifically, the revisions (1) allow entities meeting MDPP supplier enrollment conditions to participate by offering only online MDPP services via synchronous or asynchronous technology or telecommunications; (2) designate such entities' administrative location as their address under the Diabetes Prevention Recognition Program and authorize claims for payment regardless of the beneficiary's state of residence; and (3) eliminate limits on the number of times an individual may enroll in MDPP.

This section directs the Secretary of Health and Human Services, not later than January 1, 2026, to provide education and outreach—using existing communications mechanisms—to physicians and non-physician practitioners participating in Medicare (title XVIII of the Social Security Act) on periodic screening for medication-induced movement disorders associated with mental health disorder treatments in at-risk patients, including clinical guidelines and best practices for telehealth screening and evaluation and management code billing. The Secretary must seek input from relevant stakeholders to inform the outreach, which may also address other relevant telehealth screening services.

This section directs the Comptroller General of the United States to conduct a technology assessment of, and submit to Congress a report on, the capabilities and limitations of wearable medical devices used to support clinical decision-making, not later than 18 months after enactment of this Act. The report must describe (1) the potential of such devices to accurately prescribe treatments, (2) the benefits and challenges of artificial intelligence to augment such capabilities, and (3) policy options to enhance benefits and mitigate challenges of developing or using such devices.

This section extends the adjustment to the calculation of the Medicare hospice aggregate cap amount through 2034 (from 2033) by amending two clauses of section 1814(i)(2)(B) of the Social Security Act. (The cap limits annual Part A payments to each hospice program for services furnished to Medicare beneficiaries in the program to a specified per-beneficiary amount.)

This section authorizes the Medicare Payment Advisory Commission (MedPAC) and the Medicaid and CHIP Payment and Access Commission (MACPAC)—independent advisory commissions to Congress on Medicare and Medicaid/CHIP payment policies, respectively—to use available funds to enter into contracts for severable services spanning two fiscal years and multiyear contracts for property and services to the same extent as executive agencies under 41 U.S.C. §§ 3902 and 3903.

This section requires the Medicare Payment Advisory Commission (MedPAC) and the Medicaid and CHIP Payment and Access Commission (MACPAC)—independent advisory bodies that analyze and recommend Medicare and Medicaid payment policies, respectively—to include specified Federal Acquisition Regulation (FAR) clauses in all contracts for goods and services entered into in FY2025 and thereafter. The clauses are FAR 52.232-39 (Unenforceability of Unauthorized Obligations) and FAR 52.233-4 (Applicable Law for Breach of Contract Claim) (or successors).

This section revises maximum copayments for full-benefit low-income subsidy enrollees (i.e., those eligible for premium and cost-sharing assistance) in Medicare Part D prescription drug plans. (1) It establishes tiered copayment limits under SSA §1860D–14(a)(1)(D)(ii) of $1 (or the lower plan copayment) for generic drugs or preferred multiple-source drugs (as defined in SSA §1927(k)(7)(A)(i)) and $3 (or lower plan copayment) for other drugs for plan years before 2027; and, for 2027 and subsequent years, $0 for generics, with CPI-U-indexed amounts (all items, U.S. city average, as of September of the prior year) for preferred multiple-source drugs from a $1 base and for other drugs from a $3 base (rounded to the nearest 5 cents or 10 cents, respectively, or the lower plan copayment). (2) It limits an adjustment mechanism in §1860D–14(a)(4)(A)(ii) to years before 2027 (from applying to all subsequent years).

This section requires Medicare Advantage (MA) organizations offering specified MA plans (i.e., network-based plans or qualifying Medicare Advantage private fee-for-service plans) to maintain accurate, publicly available online provider directories starting plan year 2027, including provider name, specialty, contact information, address, new patient status, disability accommodations, cultural/linguistic capabilities, and telehealth options. Such organizations must verify directory information at least every 90 days (or annually for hospitals/facilities as specified by the Secretary), indicate unverified information, and remove non-participating providers within 5 business days. The section further establishes enrollee cost-sharing protections starting plan year 2027, limiting enrollee liability to the lesser of in-network cost-sharing or otherwise applicable amounts for covered services furnished by a non-network provider listed in the directory on the appointment date. (Thus, enrollees relying on inaccurate directories are protected from higher out-of-network costs.) MA organizations must notify enrollees of these protections annually before the coordinated election period, in directories, and via explanations of benefits. Additionally, the section requires annual provider directory accuracy analyses using random samples (prioritizing high-inaccuracy specialties, as determined by the Secretary) for specified MA plans starting plan year 2027, with related contract provisions and reporting.

This section establishes Medicare Part B coverage for multi-cancer early detection screening tests (as defined in new section 1861(nnn) of the Social Security Act)—i.e., FDA-cleared or approved genomic sequencing blood tests (or comparable tests) for concurrent detection of multiple cancers, determined reasonable and necessary by the Secretary through the national coverage determination process—furnished on or after January 1, 2029. It sets payment under new section 1834(aa) equal to the payment rate for the multi-target stool DNA colorectal cancer screening test before January 1, 2031, and thereafter the lesser of that rate or the clinical laboratory fee schedule amount under section 1834A. It limits coverage to individuals ages 50 through 64 in 2029 (with the upper age limit increasing by one year annually thereafter) who have not received such a test in the prior 11 months, except for tests later assigned an A or B recommendation by the U.S. Preventive Services Task Force (USPSTF). It makes conforming amendments to sections 1833(a) and (h) and 1862(a)(1)(A) to incorporate payment under section 1834(aa) and exclude these tests from non-coverage requirements; it further clarifies that coverage of these tests does not affect Medicare coverage of other cancer screenings (e.g., breast, cervical, colorectal, lung, prostate).

This section amends the Medicare definition of durable medical equipment (DME) in 42 U.S.C. 1395x(n) to deem certain external infusion pumps, associated home infusion drugs (as defined in subsection (iii)(3)(C)), and other supplies as meeting the "appropriate for use in the home" requirement (per 42 C.F.R. 414.202) if (1) the drug's FDA-approved prescribing information requires administration by or under the supervision of a health care professional; (2) a qualified home infusion therapy supplier (as defined in subsection (iii)(3)(D)) administers or supervises the drug in the patient's home; and (3) the prescribing information requires at least 12 annual infusions intravenously, subcutaneously, or at rates necessitating an external pump. The change applies beginning with the first calendar quarter on or after one year after enactment. (Thus, Medicare covers these items under the DME benefit for patients needing professionally supervised home infusion therapy.) This section also directs the Secretary of Health and Human Services to notify patients of Medicare cost sharing for home infusion therapy compared to other care settings.

This section requires prescription drug plan (PDP) sponsors to permit participation by any willing pharmacy meeting standard contract terms as a network pharmacy and, for plan years beginning on or after January 1, 2028, establishes standards for reasonable and relevant contract terms and conditions, to be set by the Secretary by the first Monday in April 2027 following a request for information issued by April 1, 2026. It also requires the Secretary, for plan years beginning on or after January 1, 2028, to publish reports at least every two years until 2034, and periodically thereafter, on trends in payments to, participation by, and dispensing volumes of essential retail pharmacies (i.e., non-affiliate retail pharmacies in medically underserved areas or locations lacking nearby alternatives—rural within 10 miles, suburban within 2 miles, or urban within 1 mile), including comparisons to non-essential pharmacies and between PDPs and Medicare Advantage prescription drug (MA-PD) plans.

This section establishes requirements for pharmacy benefit managers (PBMs) under Medicare Part D prescription drug plans (PDPs), applicable to PDP sponsor contracts for plan years beginning on or after January 1, 2028. Such contracts must require PBMs and affiliates to (1) derive remuneration only from bona fide service fees for services related to covered Part D drugs (with exceptions for certain incentive payments and manufacturer rebates or discounts fully passed through to the PDP sponsor, subject to Secretary review of arrangements for fair market value consistency and disgorgement of improper payments); (2) apply pricing guarantees and cost performance measures transparently by consistently defining terms such as generic drug, brand name drug, specialty drug, rebate, and discount (per specified regulations where applicable), identifying exclusions, and providing wholesale acquisition cost-based equivalents when using other benchmarks; and (3) submit annual reports to the PDP sponsor and Secretary by July 1, beginning in 2028.

This section establishes payment conditions under the Medicare hospital Outpatient Prospective Payment System (OPPS) for items and services furnished on or after January 1, 2026, by an off-campus outpatient department of a provider (i.e., a hospital department not located on the hospital campus or within the specified distance from a remote hospital location, per 42 CFR 413.65). (As background, OPPS pays hospital outpatient departments at rates generally higher than the physician fee schedule applicable to physician offices; provider-based status under 42 CFR 413.65 allows off-campus departments to qualify for OPPS payments if they meet criteria including integrated operations and clinical supervision.) No such payment may be made unless (1) the department bills using a separate unique provider identifier from the provider, (2) the provider submits an initial attestation of compliance with 42 CFR 413.65 during the two-year period ending on the service date, and (3) the provider submits subsequent attestations within the Secretary of Health and Human Services' specified timeframe. The Secretary must establish, through notice-and-comment rulemaking within one year of enactment, a process for attestation submission and review (including site visits, remote audits, or other means). This section further requires the HHS Inspector General to analyze that process and submit recommendations to Congress by January 1, 2030.

This section revises subparagraph (D) of section 251A(6) of the Balanced Budget and Emergency Deficit Control Act of 1985 (2 U.S.C. 901a(6)) to provide for a 2.0 percent reduction in payments for Medicare programs specified in section 256(d) (i.e., Medicare Parts B and D, Medicare Advantage benchmark amounts, qualified resident training pass-through payments, and payments for hospice care). The section also adds subparagraph (F) requiring the President, upon submitting the FY2033 budget, to order sequestration for those Medicare programs effective immediately, with reductions of 2.0 percent for the first two months and 0 percent for the last 10 months of the fiscal year (notwithstanding the general 2 percent limit).

This section extends allotments under the Sexual Risk Avoidance Education program through December 31, 2025 (from March 31, 2025). (The program provides formula allotments to states—or competitive grants to other entities if a state does not apply—for education exclusively on sexual risk avoidance, i.e., emphasizing abstinence from sexual activity outside marriage.) Specifically, it adds allotments for the periods April 1–September 30, 2025, and October 1–December 31, 2025, with pro rata appropriations for those periods equal to portions of FY2024 and FY2025 appropriations, respectively, and updates references to fiscal years 2024, 2025, or 2026.

This section extends allotments to states under the Personal Responsibility Education Program (PREP)—which provides formula grants to states for youth education programs on avoiding out-of-wedlock pregnancy and sexually transmitted infections (including abstinence and contraceptives)—to two additional periods: April 1 through September 30, 2025, and October 1 through December 31, 2025 (from through March 31, 2025). It (1) applies the existing exception to the $250,000 minimum state allotment to these new periods; (2) revises a hold-harmless provision to cover fiscal years 2024, 2025, or 2026 (from fiscal years 2024 or 2025); and (3) provides pro rata appropriations for the new periods based on fiscal year 2024 (for April–September 2025) or 2025 (for October–December 2025) amounts.

This section increases funding for family-to-family health information centers to $7.5 million (from $3 million) and extends the covered period to October 1, 2024, through December 31, 2025 (from the portion of FY2025 before April 1, 2025). (Family-to-family health information centers, funded under the Maternal and Child Health Services Block Grant, provide information, training, and peer-to-peer support to families of children and youth with special health care needs to improve care coordination and navigation of health services.)

This section increases and reauthorizes annual funding for grants to states to address dental workforce shortages in designated dental health professional shortage areas (i.e., the program under Section 340G of the Public Health Service Act) to $15 million for FY2025 through 2029 (from $13,903,000 for FY2019 through 2023), with funds to remain available until expended. (As background, grants support state activities such as dentist loan repayment and forgiveness for serving shortage areas or as public health dentists, recruitment and retention, low-interest loans to expand Medicaid-participating practices, dental residency programs, and new or expanded oral health facilities including mobile clinics and dental homes for special needs populations.)

This section (1) reauthorizes research and activities relating to preterm labor and delivery and the care, treatment, and outcomes of preterm and low birthweight infants through FY2029 (from FY2023); (2) makes a technical correction to the PREEMIE Reauthorization Act of 2018 (Public Law 115-328) to update a section reference; (3) requires the Secretary of Health and Human Services, not later than 18 months after enactment of the Bipartisan Health Care Act, to establish an interagency working group on prematurity research and programs (previously optional "may establish"); and (4) requires the Secretary to arrange with the National Academies of Sciences, Engineering, and Medicine for a consensus study and report on preterm births—convened within 30 days of enactment and transmitted within 24 months—assessing financial costs to society (e.g., neonatal intensive care unit stays, long-term family costs, post-discharge health care); factors impacting preterm birth rates; opportunities for earlier risk detection and public health support; targeted research strategies and interventions; state best practices for reducing rates; and precision medicine and preventive care approaches. (As background, the Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act, or PREEMIE Act, authorizes CDC and other HHS offices to support grants, contracts, data collection, and public education to reduce preterm births and improve outcomes for affected infants and families.)

This section amends provisions of the maternal mortality surveillance and prevention program (42 U.S.C. 247b-12), which authorizes CDC grants to states to establish maternal mortality review committees (MMRCs) that analyze maternal deaths and develop prevention recommendations, as follows: (1) requires MMRCs to include obstetricians and gynecologists among experts in clinical specialties; revises a data access requirement from "as applicable" to "if available"; and expands MMRC duties to include coordinating with death certifiers to improve death record reports and quality, including amending cause-of-death information on death certificates as appropriate; (2) requires the CDC Director, in consultation with the HRSA Administrator, to disseminate best practices for preventing maternal mortality and morbidity—at least once per fiscal year—to hospitals, state professional society groups, and perinatal quality collaboratives, drawing from other federal maternal health programs; and (3) increases authorized funding to $100 million for each of FY2025 through 2029 (from $58 million for FY2019 through 2023).

This section revises the sickle cell disease prevention and treatment program by (1) expanding the authorized purposes in multiple provisions to include the prevention and treatment of complications of sickle cell disease, (2) authorizing the Department of Health and Human Services to make grants or enter into cooperative agreements, in addition to contracts, and (3) increasing authorized funding to $8,205,000 for each of FY2025 through 2029 (from $4,455,000 for each of FY2019 through 2023). The program supports comprehensive sickle cell disease centers, public and nonprofit sickle cell anemia organizations, and related research, screening, and education activities. The section also expresses the sense of Congress that further research should be undertaken to expand understanding of the causes of, and to find cures for, heritable blood disorders, including sickle cell disease.

This section revises the Public Health Service Act to enhance traumatic brain injury (TBI) prevention, surveillance, and state grant programs. Specifically, it (1) amends the TBI prevention section (42 U.S.C. 280b–1c) to require a comprehensive plan covering incidence and prevalence through 2030 (from 2020), with expanded focus on higher-risk populations (including those with occupational or circumstantial factors), causes, risk factors, associated injuries/fatalities, and related mental health conditions; (2) renames and expands the national TBI surveillance and registries program (42 U.S.C. 280b–1d) as the Bill Pascrell, Jr., national program to prioritize higher-risk populations, causes/risk factors (including occupation), short- and long-term outcomes, and evidence-based concussion practices, strikes prior grant authority, and requires public availability of aggregated data (including tailored prevention strategies) on the CDC website; (3) reauthorizes appropriations for TBI programs through FY2029 (from FY2024); and (4) revises state TBI grants (42 U.S.C. 300d–52) to prioritize higher-risk populations and include Tribal entities and American Indian consortia, adds a maintenance-of-effort requirement for nonfederal spending with a waiver of up to 50% of matching funds upon request, and updates the TBI definition to explicitly cover anoxic brain injuries and certain other non-congenital sources while allowing future revisions after consultation. (As background, these programs support CDC-led data collection on TBI—an acquired brain injury from external mechanical force—and fund state efforts to improve post-injury systems coordination, protection, and rehabilitation.)

This section (1) revises the definition of family caregiver under the Lifespan Respite Care Program to mean an unpaid family member, foster parent, or another unpaid individual (from unpaid adult) who provides in-home monitoring, management, supervision, or treatment of a child or adult with a special need; and (2) extends the authorization of appropriations through FY2029 (from FY2024). (The Lifespan Respite Care Program provides formula grants to eligible state agencies to enhance respite care services—short-term relief for family caregivers—and caregiver training across all ages and disabilities.)

This section revises and extends provisions of the Dr. Lorna Breen Health Care Provider Protection Act (Public Law 117-105), which supports mental health and resiliency programs for health care professionals (e.g., suicide prevention, peer support, and training). Specifically, the section (1) extends dissemination of best practices from 2 years to 5 years; (2) for the education and awareness initiative encouraging use of mental health and substance use disorder services, requires implementation not later than 2 years after enactment and annually thereafter (previously, only by that date), and extends the period to 2025 through 2029 (from 2022 through 2024); and (3) for grant programs to promote mental health among health care professionals (42 U.S.C. 294t, redesignated as 42 U.S.C. 294t note [sec. 764A]), (a) expands award priority to eligible entities that are in health professional shortage areas or rural areas or have a focus on reducing administrative burden on health care workers (previously, priority only to those in such areas), (b) revises grant terms to not less than 3 years (from 3 years), and (c) extends authorization to 2025 through 2029 (from 2022 through 2024).

This section revises the National Breast and Cervical Cancer Early Detection Program (NBCCEDP)—which provides grants to states and territories for breast and cervical cancer screening, diagnostics, and related services to low-income, uninsured, or underinsured women aged 21-64—as follows: (1) in section 1501(a) (42 U.S.C. 300k(a)), expands authorized grant purposes to expressly include cancer prevention activities; adds new purposes to enhance support services (e.g., patient navigation, evidence-based screening strategies), reduce disparities in incidence and mortality, and improve access while addressing barriers; changes "monitor" to "ensure" for certain activities; and strikes subsection (d); (2) in section 1503(a) (42 U.S.C. 300m(a)), replaces prior requirements—including a 60% minimum grant expenditure on core screening services (paras. (1)-(2) of 1501(a)), specified screening procedures (e.g., mammography, Pap smears), a 40% cap on other services (paras. (3)-(6) of 1501(a)), and full services by end of second grant year—with simplified assurances to provide screening and diagnostic services consistent with evidence-based recommendations and all 1501(a) services by end of second grant year; strikes prior paras. (2) and (4) and subsection (d) (demonstration waivers for up to five states); (3) in section 1508(b) (42 U.S.C. 300n–4(b)), revises HHS reporting to Congress to every five years beginning two years after enactment (from annually beginning one year after 2007 reauthorization), covering preceding two fiscal years for first report and preceding five fiscal years thereafter (from preceding fiscal year), and updates Senate committee reference to Health, Education, Labor, and Pensions; (4) in section 1510(a) (42 U.S.C. 300n–5(a)), authorizes $235.5 million annually for FY2025 through FY2029 (in addition to prior authorizations through FY2011 and other years); and (5) requires a GAO study, due by September 30, 2027, estimating NBCCEDP-eligible population, summarizing service trends, and assessing barriers to screenings.

This section establishes the DeOndra Dixon INCLUDE Project (i.e., INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE Project) within the National Institutes of Health (NIH) to conduct research, training, and investigation related to Down syndrome (i.e., trisomy 21). The program requires (1) high-risk, high-reward research on trisomy 21 effects on human development and health; (2) lifespan research including cohort studies on co-occurring conditions and interventions; (3) expanded clinical trials inclusive of or targeted to individuals with Down syndrome; (4) research on biological mechanisms of anomalies, dysfunction, and stunted growth; (5) research to improve diagnosis and treatment of co-occurring conditions including biomarkers; (6) research on causes and treatment of co-occurring conditions such as Alzheimer’s disease, related dementias, and autoimmunity; and (7) research to improve quality of life for individuals with Down syndrome and their families. This section further directs NIH to coordinate Down syndrome research across its institutes and centers (prioritizing nonduplicative activities); consult stakeholders including patient advocates; and submit biennial reports to specified congressional committees cataloging funded research, involved institutes or centers, and any resulting real-world evidence for clinical and medical applications.

This section establishes the Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone Initiative (IMPROVE Initiative) under the National Institutes of Health (NIH) to advance research on (1) reducing preventable causes of maternal mortality and severe maternal morbidity; (2) reducing related health disparities, including for medically underserved populations; and (3) improving health for pregnant and postpartum women before, during, and after pregnancy. The Initiative requires an integrated approach to study biological, behavioral, and other factors affecting maternal mortality and morbidity—building an evidence base for improved regional outcomes—along with implementation and evaluation of community-based interventions and identification of risk factors and biological mechanisms for leading causes, with authority expiring on September 30, 2029.

This section modifies requirements for the Organ Procurement and Transplantation Network (OPTN), which operates the national organ waiting list and computer-based matching system to allocate donated organs equitably among transplant candidates. Specifically, in subsection (b)(2), it (1) updates the required communications service to a 24-hour telephone or information technology service (from telephone service); (2) adds a requirement to encourage integration of electronic health records systems via application programming interfaces (or successors) among hospitals, organ procurement organizations, and transplant centers—including automated referrals and remote electronic access to potential donor records, in compliance with HIPAA privacy regulations; and (3) adds a requirement to consider establishing a public dashboard displaying transplant numbers and types, organs entering the OPTN that were not transplanted, and related statistics updated more frequently than annually. The section also adds subsection (d) authorizing the Secretary to collect registration fees from OPTN members for each transplant candidate placed on the national list, with fees available until expended to support OPTN operations (directly collected or via awards); credited as discretionary offsetting collections per appropriations Acts; posted quarterly on the OPTN website by member and supported activities; subject to a GAO review and report to specified congressional committees within two years of enactment (to the extent data are available); and sunsetting three years after enactment.

This section revises the grant program under the Public Health Service Act (42 U.S.C. 274f) for reimbursing living organ donors' travel, subsistence, and incidental nonmedical expenses (with preference for donors otherwise unable to pay) as follows: (1) prohibits grant recipients from considering the income of the organ recipient when reimbursing the donor; (2) eliminates the restriction against using grant funds to the extent payment for the donor's expenses can reasonably be expected from the organ recipient (thus, permitting reimbursement regardless of the recipient's ability to pay); and (3) requires the Secretary to submit to Congress and publicly release an annual report, not later than December 31 each year beginning in FY2026, on whether prior-year grants fully reimbursed all participating donors, including estimates of unreimbursed donors and additional funding needed for full reimbursement.

This section authorizes $25,000,000 for each of fiscal years 2025 through 2027 to carry out the program for pediatric studies of drugs. (As background, the program requires the NIH Director to develop and update a priority list of needs in pediatric therapeutics—focusing on gaps such as developmental pharmacology and pediatric clinical trials—and to award grants or contracts for related pediatric research.)

This section establishes oversight requirements for pharmacy benefit management (PBM) services under group health plans and group health insurance coverage for plan years beginning on or after 30 months after enactment (the effective date). Specifically, it prohibits such plans, issuers offering group coverage, or PBMs acting on their behalf from entering into, extending, or renewing contracts on or after the effective date with an applicable entity unless the entity agrees (1) not to limit or delay information disclosure to the plan in a manner that prevents PBM reporting and (2) to provide information necessary for such reports. It further requires PBMs, for contracts entered, extended, or renewed on or after the effective date, to submit reports to the plan semiannually (or quarterly upon plan request, under the same terms and at the same cost) in plain language and machine-readable format containing, with respect to covered drugs during the reporting period, specified information including (for large employer self-insured plans or those electing): contracted compensation to PBMs and pharmacies (with differences), drug names and National Drug Codes, dispensing channels, brand/generic status with wholesale acquisition costs or average wholesale prices, claim volumes and participant counts, dosage units and days supply, net prices per course of treatment, participant out-of-pocket spending, total net spending, and rebates or other remuneration.

This section revises exemptions from ERISA prohibited transaction rules for reasonable service contracts (29 U.S.C. 1108(b)(2)) as follows: (1) exempts a responsible plan fiduciary from ERISA §§406(a)(1)(C) and (D)—prohibiting failure to transmit participant contributions timely—despite a covered service provider's failure to remit required amounts under §406(a)(1)(C)(i), if the fiduciary lacked knowledge and reasonably believed remittances occurred, promptly requests remission in writing, and notifies the Secretary if unresolved within 90 days; and (2) provides that, for plan years beginning on or after 30 months after enactment, a contract or arrangement for pharmacy benefit management (PBM) services (including through a group health issuer or third-party administrator) is not reasonable unless the PBM remits 100% of drug-related rebates, fees, discounts, and other remuneration to the plan or issuer quarterly within 90 days (or sooner for underpayments), fully discloses such amounts, makes records available for annual audit, and ensures rebate aggregators remit to the PBM within 45 days quarterly, with audit access to rebate contracts.

This section amends section 505(j)(3) of the Federal Food, Drug, and Cosmetic Act to require the FDA, upon request by a prospective or actual abbreviated new drug application (ANDA) sponsor (i.e., generic drug applicant) or on its own initiative, to disclose whether the sponsor's drug is qualitatively and quantitatively the same as the listed drug (i.e., reference listed drug) with respect to specified inactive ingredients; if not the same, to identify differing ingredients and quantitative deviations; and to refrain from rescinding a sameness determination after ANDA submission absent a listed drug formulation change for safety or effectiveness reasons or a documented error (with notice to the sponsor). (As background, ANDA sponsors must demonstrate bioequivalence to the listed drug, and inactive ingredient information is generally protected as trade secrets under laws including 18 U.S.C. 1905.) It authorizes these disclosures as permitted by law, including for purposes of 18 U.S.C. 1905 (prohibiting unauthorized disclosure of confidential business information by federal personnel), without otherwise affecting trade secret protections; directs FDA to issue draft guidance within one year of enactment on sameness determinations (including for pH adjusters), with at least 60 days for public comment and final guidance within one year thereafter; and makes the disclosure requirement applicable upon enactment irrespective of guidance finalization.

This section amends the patent infringement safe harbor provisions under 35 U.S.C. 271(e) applicable to the abbreviated biologics approval pathway (i.e., biosimilars under section 351(k) of the Public Health Service Act (PHSA), 42 U.S.C. 262(k)). Specifically, it (1) expands the scope of infringement for certain pre-approval submissions to encompass any patent claiming the biological product, a method of using the product, or a method or product used to manufacture the product; and (2) limits a reference product sponsor to asserting not more than 20 qualifying patents in an infringement action against a PHSA §351(k) applicant, not more than 10 of which may have issued after the date specified in PHSA §351(l)(7)(A). Qualifying patents must (i) claim the biosimilar product (or a use thereof) or a manufacturing method or product; (ii) be included on the list under PHSA §351(l)(3)(A); and (iii) either have an actual filing date more than four years after reference product approval or claim a manufacturing process not used by the sponsor. Courts may increase the 20-patent limit without undue delay if required in the interest of justice or for good cause (e.g., applicant's failure to provide required information under PHSA §351(k)(2)(A), material changes to the applicant's product or process, or specified patent issuance delays); the limit applies only if the applicant completes required actions under specified PHSA §351(l) provisions and does not apply to patents claiming methods of using the product for therapy, diagnosis, or prophylaxis. The amendments apply to PHSA §351(k) applications submitted on or after enactment.

This section extends the safe harbor permitting high-deductible health plans (HDHPs)—required for health savings account (HSA) eligibility—to waive deductibles for telehealth and other remote care services. It applies the safe harbor to months beginning after March 31, 2025, and before January 1, 2026 (in addition to prior periods ending before January 1, 2023), and to plan years beginning after December 31, 2024, and before January 1, 2027 (in addition to prior periods ending before January 1, 2025). (Thus, HDHP enrollees may access such services without satisfying the deductible during these periods while retaining HSA eligibility.)