Medicare Part D

The HHS Office of Inspector General will evaluate the extent and quality of Medicare Part D plan coverage for biosimilars to AbbVie Inc.’s Humira (adalimumab) and expects to issue a report on the study in 2025, according to a recent update to the OIG’s work plan.

The study could provide fodder for reforms to pharmacy benefit manager rebating practices and for changes in Part D coverage policy that could help boost the uptake of biosimilars. Stakeholders and policy makers have viewed adalimumab biosimilars as a test case for the viability of the biosimilar model.

The CDC announced on Nov. 16 that it had made available more than 77,000 additional doses of Beyfortus (nirsevimab-alip), a monoclonal antibody intended to protect infants from severe respiratory syncytial virus (RSV) disease. Since the FDA approved Beyfortus in July, there have been supply issues and insurance coverage limitations for RSV medications. Sanofi, which manufactures Beyfortus alongside AstraZeneca, noted last month that it had seen “an unprecedented” level of demand for the medication and that it was working with the CDC to distribute more doses through the agency’s Vaccines for Children program.

CMS has delayed its plan to cover Medicare patients’ full cost of preexposure prophylaxis (PrEP) using FDA-approved antiretroviral drugs to prevent HIV infection in high-risk patients, according to KFF. CMS had announced the proposal in July and expected to make it official on Oct. 10, but KFF said the delay has occurred while CMS “is still working out details on how to transition coverage for patients already taking the drugs.” The drugs can cost more than $20,000 per year in the U.S.

As of 2023, about 50.5 million Medicare beneficiaries are enrolled in a plan with Part D prescription drug coverage, with 44% in stand-alone Prescription Drug Plans (PDPs) and 56% in Medicare Advantage Prescription Drug Plans (MA-PDs), according to a KFF analysis.

The three largest Part D insurers by market share — UnitedHealth Group, CVS Health Corp. and Humana Inc. — account for 57% of enrollment in 2023. More than half of UnitedHealth’s and Humana’s Part D enrollees chose MA-PDs, while the majority of CVS Health, Centene Corp. and The Cigna Group Part D enrollees are in PDPs.

Deep within two new proposed health insurance regulations are provisions that would alter how Medicare Advantage and Affordable Care Act exchanges cover prescription drugs — and some of them are garnering praise from patient advocates.

For example, the HIV+Hepatitis Policy Institute welcomed two of the proposals in the 2025 Notice of Benefit and Payment Parameters (NBPP), the annual regulation governing the ACA marketplaces, which CMS released on Nov. 15.

One of those provisions would codify existing policies surrounding how health plans treat prescription drugs that aren’t part of a given state’s essential health benefits (EHB) benchmark plan. Under the ACA, individual market plans must cover items and services in 10 core benefit categories, including prescription drugs, and each state is responsible for defining which drugs make the must-cover list.

In a Nov. 15 rule proposing policy and technical changes for the 2025 Medicare Advantage and Part D plan year, CMS made numerous changes aimed at protecting beneficiaries from “predatory marketing” and ensuring they enroll in the MA plans that best meet their needs. And depending on how plans execute these new provisions, some have the potential to impact Star Ratings, industry experts observe. At the same time, the rule proposed several methodological enhancements, clarifications and operational updates to the 2025 Star Ratings.

For example, CMS provided an update on its plans to include the Universal Foundation of quality measures that would align across all CMS programs and to provide a “building block to which programs will add additional aligned or program-specific measures.” As part of this plan, CMS said it has submitted the Initiation and Engagement of Substance Use Disorder Treatment (IET) Part C measure to the Measures Application Partnership (MAP) for review as a measure under consideration. Additionally, CMS indicated that it will submit three other Universal Foundation measures — Adult Immunization Status, Depression Screening and Follow-Up, and Social Need Screening and Intervention, which are now reported as display measures — to MAP prior to proposing the use of those measures in future rulemaking.

The Senate Finance Committee on Nov. 8 unanimously approved legislation to block pharmacy benefit manager practices that result in higher cost-sharing for beneficiaries.

The bill does not include provisions that were included in an earlier draft that would ensure “high discount” biosimilars get favorable formulary tiering. But those policies may be added back before the bill reaches the Senate floor for a vote.

The committee is planning to combine the bill with other PBM reform legislation it approved in July which includes a policy that would de-link PBM compensation from the list price of drugs.

While a lot of the attention around the Inflation Reduction Act (IRA) has focused on its implications for pharma manufacturers and Medicare Part D plans, much of its focus is on patients and making sure they can access the prescription medications they need at a price they can afford. While aspects such as the out-of-pocket cap for Medicare beneficiaries and the limit on premium increases for plans are welcome developments, some uncertainties still exist around the actual implementation of the law and how patients may be affected. On Oct. 19, life sciences consulting firm Innopiphany, LLC brought together three speakers from patient-advocacy groups to discuss their hopes, concerns and what they have experienced so far.

Only 2% of Medicare beneficiaries who enrolled in a stand-alone Prescription Drug Plan (PDP) in 2024 will be in contracts with 4 or more stars, compared to 42% in the 2022 plan year and 9% in 2023, according to CMS’s recently released estimates. The average Star Rating for PDPs dropped to 3.11 in 2024 from 3.70 in 2022, with two contracts receiving 1.5 stars.

The distribution change is largely fueled by methodology changes in how many of the Star Ratings are calculated. Known as Tukey outlier deletion, the changes center on removing outlier contract scores when determining the cut points for all non-Consumer Assessment of Healthcare Providers and Systems measures.

Only 2% of Medicare beneficiaries who enrolled in a stand-alone Prescription Drug Plan (PDP) in 2024 will be in contracts with 4 or more stars, compared to 42% in the 2022 plan year and 9% in 2023, according to CMS’s recently released estimates. The average Star Rating for PDPs dropped to 3.11 in 2024 from 3.70 in 2022, with two contracts receiving 1.5 stars.

The distribution change is largely fueled by methodology changes in how many of the Star Ratings are calculated. Known as Tukey outlier deletion, the changes center on removing outlier contract scores when determining the cut points for all non-Consumer Assessment of Healthcare Providers and Systems measures.

During the 2024 Medicare Annual Election Period that starts on Oct. 15, a total of 708 stand-alone Prescription Drug Plans will be available for beneficiaries in 2024 nationwide, a 12% drop from 2023. Only 126 PDPs will be offered without a premium to enrollees receiving the Low-Income Subsidy (LIS) in 2024, compared with 191 PDPs in 2023.