Mandating Exclusive Review of Individual Treatments (MERIT) Act This bill specifies that coverage determinations for drugs and biologics under Medicare must be made with respect to each drug or biologic, rather than with respect to a class of drugs or biologics.
Impact
If enacted, HB133 could significantly impact how Medicare evaluates treatment options, with the potential to improve access to necessary medications for beneficiaries. By shifting the focus to individual treatments, the bill seeks to ensure that Medicare beneficiaries are not denied coverage based on class-wide determinations that might overlook the unique needs of individual patients. This change could pave the way for more personalized healthcare approaches, although it may also raise questions regarding how this individualized assessment will be practically implemented and the implications for overall healthcare costs.
Summary
House Bill 133, known as the Mandating Exclusive Review of Individual Treatments Act (MERIT Act), aims to amend the national coverage determination process under the Medicare program. The primary focus of this bill is to clarify that when evaluating the necessity and reasonableness of drugs or biologicals, each treatment must be assessed individually rather than as part of a broader class. This change is intended to ensure that specific patient needs are considered in coverage decisions, potentially allowing for more tailored healthcare solutions within the Medicare system. The bill was initially introduced on January 9, 2023, and has undergone various committee reviews and amendments since then.
Sentiment
The sentiment surrounding HB133 is generally positive among its proponents, including various healthcare advocates who argue that the bill promotes a patient-centered approach to Medicare. Supporters contend that allowing for individualized reviews will enhance treatment access and improve health outcomes for beneficiaries. Conversely, there could be concerns from budget-conscious lawmakers about the financial implications of potentially higher coverage rates for newly approved treatments. As such, the sentiment reflects a mix of optimism for patient welfare and caution regarding the economic consequences.
Contention
Notable points of contention regarding HB133 include concerns about the adequacy of resources for implementing a system that assesses individual treatments effectively and efficiently. Some legislators may worry that the proposed changes could lead to increased costs for the Medicare program and affect its sustainability. Furthermore, the clarity of what constitutes a reasonable and necessary treatment will be crucial for Medicare's operational success, and disagreements may arise regarding how these decisions should be made and by whom.
A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products.
Lower Drug Costs for Families Act This bill applies certain Medicare prescription drug rebate requirements to prescription drugs that are available under private health insurance. Current law requires drug manufacturers to issue rebates to the Centers for Medicare & Medicaid Services for brand-name drugs without generic equivalents under Medicare that (1) cost $100 or more per year per individual, and (2) for which prices increase faster than inflation. Manufacturers that fail to comply are subject to civil penalties. The bill applies these requirements to prescription drugs that are available in the commercial market under private health insurance. It also indexes rebate calculations to drug prices in 2016 (as opposed to 2021).
Lower Drug Costs for Families Act This bill applies certain Medicare prescription drug rebate requirements to prescription drugs that are available under private health insurance. Current law requires drug manufacturers to issue rebates to the Centers for Medicare & Medicaid Services for brand-name drugs without generic equivalents under Medicare that (1) cost $100 or more per year per individual, and (2) for which prices increase faster than inflation. Manufacturers that fail to comply are subject to civil penalties. The bill applies these requirements to prescription drugs that are available in the commercial market under private health insurance. It also indexes rebate calculations to drug prices in 2016 (as opposed to 2021).
A bill to amend title XI of the Social Security Act to alter when biosimilar biological products are eligible for price negotiations under the Medicare program.
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.