Health care costs

Medically Tailored Home-Delivered Meals Program Pilot Act

This bill requires the Centers for Medicare & Medicaid Services (CMS) to establish a temporary program through which certain Medicare beneficiaries with diet-impacted diseases may receive medically tailored meals at home to reduce their rate of hospital readmissions.

Specifically, the CMS must select, upon application, at least 40 hospitals to participate in a six-year program to deliver medically tailored meals to qualifying individuals' homes. Participating hospitals must meet specified program integrity and quality of care metrics and certify that they are able to provide the required meals and associated medical nutrition therapy. Hospitals must have a physician, registered dietitian or nutrition professional, advanced practice nurse, or clinical social worker screen inpatients upon discharge from the hospital and every 12 weeks thereafter to determine whether these individuals qualify for the meal program.

In order to qualify for the program, individuals must have a diet-impacted disease (e.g., kidney disease), live at home, not be receiving extended care services or hospice care, be limited with respect to at least two activities of daily living, and meet any other criteria for high-risk readmissions (as determined by the CMS).

Seniors’ Access to Critical Medications Act of 2025

This bill temporarily expands flexibilities under the Stark law (i.e., the Physician Self-Referral Law) for certain physicians who dispense covered outpatient drugs under the Medicare prescription drug benefit at the physician's office location (e.g., through an integrated pharmacy). The Stark law generally prohibits physicians from referring patients to receive services that are payable under Medicare or Medicaid from entities in which the physician or an immediate family member has a financial relationship.

Specifically, the bill allows, from 2026-2030, physicians to dispense such drugs from the physician's office, including through in-person pickup by a caregiver or via mail, if (1) the physician prescribed the drug, (2) the beneficiary has an ongoing relationship with the physician, (3) the beneficiary had at least one face-to-face visit with the physician in the prior year, and (4) the physician bills for the drug. These requirements also apply to physicians within the same group practice.

The Government Accountability Office must report on pharmacies or pharmacy networks that dispense significantly more covered drugs under the Medicare prescription drug benefit after the bill's enactment, the extent to which such pharmacies and networks are owned by physicians or integrated into physician practices, and the common characteristics of these types of arrangements.

Aviation Medication Transparency Act of 2025

This bill directs the Federal Aviation Administration (FAA) to compile, publish, and annually update a list of medications that may be safely prescribed to pilots and air traffic controllers for the purposes of issuing a medical certification. The list must be publicly available on the FAA website and distributed to those seeking a license and medical certification.

Currently, the FAA does not have a list of approved medications. However, the FAA does have lists for Aviation Medical Examiners of Do Not Issue medications and Do Not Fly medications.

Apples to Apples Comparison Act of 2025

This bill requires additional reporting and disclosures regarding Medicare enrollment and expenditures.

Specifically, the bill requires the Centers for Medicare & Medicaid Services to annually report on and publish information on its website regarding expenditures for Medicare hospital services and medical services, the Medicare prescription drug benefit, and Medicare Advantage (MA), including for those who are enrolled in one program but not others or have supplemental insurance. This information must be broken down by county and metropolitan statistical area for each month over the prior 10-year period and for each month over the next 5-year period.

In addition, the Medicare Payment Advisory Commission must annually analyze and report on expenditures for Medicare beneficiaries who have an MA plan compared to those who do not have an MA plan. The Boards of Trustees for Medicare must annually report on expenditures for (1) Medicare beneficiaries who have either hospital services or medical services but not both, and (2) Medicare beneficiaries who have both hospital and medical services but do not have an MA plan.

Preventive Health Savings Act

This bill requires the Congressional Budget Office (CBO), upon receiving a request from Congress, to determine if proposed legislation would reduce spending outside of the 10-year budget window through the use of preventive health care.

Under the bill, the term preventive health care generally refers to an action that focuses on the health of the public, individuals, and defined populations in order to protect, promote, and maintain health and wellness and prevent disease, disability, and premature death.

If CBO determines that the proposed legislation would result in net reductions in budget outlays from the use of preventive health care, any CBO projection regarding the legislation must include (1) a description and estimate of the reductions in outlays, and (2) a description of the basis for these conclusions.

Any estimate provided by CBO pursuant to this bill must be used as a supplementary estimate and may not be used to determine compliance with the Congressional Budget Act of 1974 or any other budgetary enforcement controls.

Prescription Pricing for the People Act of 2025

This bill requires the Federal Trade Commission (FTC) to report about anticompetitive practices and other trends within the pharmaceutical supply chain that may impact the cost of prescription drugs.

The report must address whether pharmacy benefit managers (PBMs) (1) reimburse pharmacies owned by the PBM at a higher price than other pharmacies, and (2) implement formulary designs to increase the market share of higher-cost prescription drugs or depress the market share of lower-cost prescription drugs.

The FTC also must provide recommendations to increase transparency in the supply chain, prevent anticompetitive practices, and ensure that consumers benefit from cost savings or efficiencies that result from mergers and consolidations.

Additionally, the FTC must report the number and nature of complaints the FTC receives relating to an allegation of anticompetitive conduct by a manufacturer of a sole-source drug.

Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act or the CLEAR LABELS Act

This bill requires drugs and active pharmaceutical ingredients made available in the U.S. market to be labeled with the names and locations of their manufacturers.

Specifically, a finished, packaged drug product must be labeled with the name and place of business of (1) the original manufacturer (or manufacturers) of each active pharmaceutical ingredient; (2) the original manufacturer of the finished drug product; and (3) the packer or distributor, if any. This information must be printed on the product label or made available electronically. Active pharmaceutical ingredients (which are generally sold to manufacturers and researchers, not consumers) must also be labeled with the name and place of business of their original manufacturers.

Under the bill, the original manufacturer is the establishment that conducts the majority of the significant phases of manufacturing to produce the ingredient or product.

The Food and Drug Administration (FDA) has discretion to determine whether a violation of these requirements constitutes misbranding and to assess a civil fine. The FDA must consider certain factors in determining whether to assess a fine, including whether the violator was notified of their noncompliance and was provided an opportunity to correct the violation.

Finally, the FDA must coordinate with U.S. Customs and Border Protection to address any overlap between these requirements and existing requirements for imported drugs.

These provisions take effect five years after the bill is enacted.

Medicare Access to Rural Anesthesiology Act

This bill modifies the Medicare payment methodology for anesthesiologists in rural hospitals.

Specifically, the bill provides that payment must be made on a reasonable cost basis for anesthesiologists in rural hospitals and critical access hospitals that have no more than 800 surgical procedures requiring anesthesia services per year (or a higher number set by the Centers for Medicare & Medicaid Services).

Rural Patient Monitoring Access Act or the RPM Access Act

This bill conditions Medicare payment for remote patient monitoring services on certain requirements.

Specifically, the bill conditions payment on (1) the ability of certain health care practitioners to be available in real time to respond to any detected anomalies; (2) the use of a system that can transmit relevant data in a format that is compatible with electronic health records, as needed; and (3) the reporting of such data, as required by the Centers for Medicare & Medicaid Services (CMS), to evaluate any cost savings as a result of such services.

The bill also establishes a floor for certain payment calculations with respect to such services.

The CMS must report on cost savings realized and expenses incurred from the use of such services over a four-year period.

Preserve Access to Affordable Generics and Biosimilars Act

This bill prohibits parties from entering into any agreement that resolves or settles a patent claim related to the sale of a drug or biological product and that has anticompetitive effects. Such an agreement is presumed to have anticompetitive effects if the filer of a generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar.

An agreement is exempt if the only consideration granted to the generic manufacturer is (1) the right to market and secure final approval for its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a U.S. patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects.

The bill provides for enforcement by the Federal Trade Commission (FTC). Violators are subject to penalties including the forfeiture of the 180-day marketing exclusivity period for a generic drug.

Additionally, when a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC and the Department of Justice concerning the agreement contains the complete agreement and any related agreements, including descriptions of any oral agreements or representations.

Joe Fiandra Access to Home Infusion Act of 2025

This bill provides for Medicare coverage of certain home infusion drugs that are administered by health care professionals at a beneficiary’s home.

Specifically, the bill provides for coverage of external infusion pumps and associated home infusion drugs for which (1) the prescription requires that the drug be administered by or under the supervision of a health care professional, (2) a qualified home infusion therapy supplier administers or supervises the administration of the drug at the beneficiary's home, and (3) the prescription requires that the drug be infused at least 12 times per year in a manner that requires the use of an external infusion pump.

Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act or the Stop STALLING Act

This bill makes it an unfair method of competition to submit an objectively baseless petition to the Food and Drug Administration (FDA) in an attempt to interfere with a competitor's application for market approval of a drug.

The bill authorizes the Federal Trade Commission to sue an individual or entity that submits such a petition to the FDA. A party found liable in such a lawsuit is subject to civil penalties, such as a fine of up to $50,000 for each day that the FDA spent reviewing the baseless petition.

Biosimilar Red Tape Elimination Act

This bill deems all biosimilars licensed by the Food and Drug Administration (FDA) interchangeable with their reference products.

A biosimilar is a biological product (e.g., a drug or vaccine) that is very similar to a brand-name biological product (i.e., the reference product). Under current law, a biosimilar that meets additional requirements may be deemed interchangeable with the reference product; this designation allows pharmacists to substitute the interchangeable biosimilar when filling a prescription for the reference product, depending on state law. Further, the first biosimilar deemed interchangeable with a given reference product is awarded a period of marketing exclusivity.

The bill eliminates additional requirements for demonstrating interchangeability so that all licensed biosimilars are deemed interchangeable with their reference products. (Draft guidance released by the FDA in 2024 proposed to make some of these interchangeability requirements optional, including studies related to the safety of switching between use of the biosimilar and reference product. It has not been finalized.)

This change takes effect 60 days after the bill is enacted, and previously licensed biosimilars must be deemed interchangeable with their reference products on that date. However, the bill preserves the exclusivity period for first interchangeable biosimilars licensed before the bill’s enactment. For example, if a new biosimilar licensed after the bill takes effect relies on the same reference product as an existing biosimilar that is subject to an unexpired exclusivity period, the new biosimilar is not deemed interchangeable with the reference product until the exclusivity period has ended.

Drug Competition Enhancement Act

This bill prohibits product hopping by drug manufacturers and authorizes the Federal Trade Commission (FTC) to enforce this prohibition.

Generally, product hopping describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a follow-on product is a modified version of the reference drug that has an indication (what the drug is used for) that is identical or substantively similar to an indication of the reference drug.

The bill establishes a presumption that product hopping has occurred when a reference drug manufacturer, after receiving notice that the Food and Drug Administration has received an application to market a competing generic (or biosimilar) version, takes certain actions such as withdrawing the reference drug from the market and selling a follow-on product.

A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition.

The bill makes product hopping an unfair method of competition and provides for enforcement by the FTC. If the FTC has reason to believe a manufacturer has violated or is about to violate this prohibition on product hopping, the FTC may institute an administrative proceeding or bring suit in federal court to stop the manufacturer’s action and seek equitable remedies, including disgorgement of unjust profits or paying restitution to those harmed.

Improving Home Dialysis Act of 2026

This bill provides for Medicare coverage of staff-assisted home dialysis respite care and renal mental health services that are furnished at the home of a beneficiary with end-stage renal disease.

Medication Affordability and Patent Integrity Act

This bill requires applicants seeking approval of a drug or licensure of a biological product to submit certain information about relevant patents to both the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO).

Specifically, the bill requires applicants to make certifications and disclosures related to each applicable patent on a proposed drug or biological product. An applicable patent is a patent or patent application held or sought by the applicant for the drug or biological product (including a formulation or composition, method of use, or method of manufacturing).

For each applicable patent, an applicant must submit to the USPTO any information material to patentability that the applicant submitted to the FDA and any information provided by the FDA in response. The applicant must certify that this submission is complete and consistent with the information the applicant provided to the FDA.

Further, for each applicable patent, an applicant must certify that certain information submitted to the FDA is consistent with information the applicant provided to the USPTO. This is specific to statements or characterizations that are material to patentability and related to (1) an applicable patent (including a statement or characterization of relevant publicly known information), or (2) analytical data included in a new drug or biological product application.

The bill establishes a defense to a patent infringement action if the owner of an applicable patent negligently or intentionally failed to make the disclosures required by these provisions.

Medicare Advantage MLR Transparency Act

This bill requires Medicare Advantage (MA) organizations to publish certain information regarding revenue and expenses and to present information about benefits in a certain manner.

Specifically, MA organizations must submit to the Centers for Medicare & Medicaid Services and publish on their websites information about the revenue received under each offered plan and a breakdown of related expenses, including for items other than claims. MA organizations must also, to the extent practicable, present electronic information about plan benefits to beneficiaries in a manner that is similar to how such information is presented by private insurers.