Us Congress 2023-2024 Regular Session

Us Congress House Bill HB5461

Introduced
9/14/23  
Refer
9/14/23  

Caption

Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023

Impact

The bill specifically addresses the formulary requirements imposed on PDP sponsors, stipulating that for plan years commencing on or after January 1, 2024, each formulary must include preferred generic drugs and at least two biosimilar products that are cheaper than their reference counterparts. Additionally, the bill aims to prohibit PDP sponsors from imposing restrictive access limits such as prior authorization on these required medications, thereby facilitating easier access for seniors to needed drugs without unnecessary barriers.

Summary

House Bill 5461, known as the 'Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023', aims to enhance the availability of prescription drugs for seniors under the Medicare Part D program by mandating that sponsors of prescription drug plans (PDPs) include certain generic drugs and biosimilar biological products on their formularies. This requirement is intended to ensure that these lower-cost alternatives are accessible to beneficiaries, thereby potentially reducing their out-of-pocket expenses for medications.

Contention

Despite its potential benefits, HB 5461 may face contention regarding the implementation of these requirements among PDP sponsors. Some industry stakeholders may express concerns about the operational challenges and financial implications of including additional drugs on formularies. Additionally, there could be debates regarding the efficacy and safety of generic drugs and biosimilars compared to their brand-name counterparts, which some may argue could impact the overall quality of care if not addressed properly.

Companion Bills

No companion bills found.

Previously Filed As

US SB2129

Ensuring Access to Lower-Cost Medicines for Seniors Act

US HB5372

Expanding Seniors' Access to Lower Cost Medicines Act of 2023

US HB950

Saving Seniors Money on Prescriptions ActThis bill establishes reporting requirements for pharmacy benefit managers (PBMs) under the Medicare prescription drug benefit and Medicare Advantage, particularly relating to the prices of prescription drugs.Specifically, PBMs must (1) disclose certain information underlying cost performance measurements (e.g., exclusions and terms), and (2) report to prescription drug plan (PDP) sponsors (and to the Centers for Medicare & Medicaid Services upon request) an itemized list of prescription drugs that were dispensed during the previous year and related data about costs, claims, affiliated pharmacies, and other specified information. PDP sponsors may audit PBMs to ensure compliance with this bill's requirements and must annually certify their compliance; PBMs are responsible for any associated civil penalties for violations.In addition, the Government Accountability Office must study federal and state reporting requirements for health plans and PBMs with respect to prescription drug price transparency and recommend ways to streamline these requirements.

US HB3227

Ensuring Seniors’ Access to Quality Care Act

US HB3561

PATIENT Act of 2023 Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023

US SB2973

Modernizing and Ensuring PBM Accountability Act

US HB8261

Preserving Telehealth, Hospital, and Ambulance Access Act

US HB8725

Increasing Medication Access for Seniors Act of 2024

US HB6465

PLASMA Act Preserving Life-saving Access to Specialty Medicines in America Act

US HB5385

Medicare PBM Accountability Act

Similar Bills

CA SB1452

Biological products.

TX SB190

Relating to the prescription and pharmaceutical substitution of biological products.

TX HB542

Relating to the prescription and pharmaceutical substitution of biological products.

AR SB140

To Mandate The Use Of Biosimilar Medicines Under Health Benefit Plans; To Require A Healthcare Provider To Prescribe Biosimilar Medicines; And To Improve Access To Biosimilar Medicines.

ME LD2114

Resolve, Directing the Superintendent of Insurance to Collect Data from Health Insurers Related to Prescription Drug Coverage of Generic Drugs and Biosimilars

US SB1096

Preserve Access to Affordable Generics and Biosimilars Act

TN SB0436

AN ACT to amend Tennessee Code Annotated, Title 4; Title 53; Title 56; Title 68 and Title 71, relative to biosimilar medicine.

TN HB1198

AN ACT to amend Tennessee Code Annotated, Title 4; Title 53; Title 56; Title 68 and Title 71, relative to biosimilar medicine.