Medicare Part D

In two recent proposals, CMS outlines numerous changes to technical aspects of the Medicare Part D program — many of which are related to provisions in the Inflation Reduction Act (IRA) that restructured the Part D benefit phases. Sources tell AIS Health, a division of MMIT, that the proposals could have both positive and negative effects on Part D plan sponsors and beneficiaries and will likely attract a bevy of industry feedback.

The documents in question are the 2025 Advance Notice of payment changes for Medicare Advantage and Part D plans and the Draft 2025 Part D Redesign Program Instructions. While the Advance Notice is unveiled around the same time every year, the draft Part D redesign instructions are being issued to help implement provisions of the IRA that make major changes to the structure of the Part D benefit.

After a significant decline in Star Ratings performance for 2024, Elevance Health, Inc. and its affiliates have filed a lawsuit challenging CMS’s implementation of the Tukey outlier deletion methodology. Intended to infuse more “predictability and stability” into the Star Ratings by removing outliers from the cut point calculations for certain measures, its introduction was “fraught with errors and ambiguities during rulemaking” and marks a violation of the Administrative Procedure Act (APA), contends Elevance. And according to a leading Star Ratings expert, Elevance may not be the only MA insurer to sue CMS over its controversial implementation of the methodology.

The suit was filed by Elevance and affiliated entities in 18 states on Dec. 29 in the U.S. District Court for the District of Columbia. In its complaint, Elevance contends that CMS’s actions were “unlawful, and arbitrary and capricious” when it applied Tukey to the 2024 Star Ratings while contradicting its own policy of establishing “guardrails” for determining Star measure cut points. It also alleges that CMS was arbitrary and capricious when calculating the cut points and determining the plaintiffs’ Star Rating on a single Part D measure — Call Center-Foreign Language Interpreter and TTY Availability.

As changes such as the application of the Tukey outlier deletion methodology and the introduction of the Health Equity Index stand to make the Medicare Advantage landscape more competitive, CMS in recent weeks issued three contract terminations based on poor performance over a three-year period. While the COVID-19 public health emergency afforded MA and Part D insurers certain flexibilities, experts say the recent enforcement actions signal a tougher CMS coming out of the PHE.

Modern Healthcare on Jan. 8 broke the news that consistently poor Star Ratings for Centene Corp.’s WellCare Health Insurance of Arizona and WellCare Health Insurance of North Carolina would force the exits of two Medicare Advantage Prescription Drug (MA-PD) contracts from the MA market. According to separate letters to the subsidiaries dated Dec. 27, CMS decided to impose intermediate sanctions after WellCare failed to achieve a Part C summary Star Rating of at least 3 Stars in three consecutive rating periods for the specific contracts. That means the contracts had to stop enrolling new Medicare beneficiaries and cease all marketing activities, effective Jan. 12.

Thanks to the Inflation Reduction Act (IRA) of 2022, sponsors of Medicare Advantage Prescription Drug (MA-PD) plans and Prescription Drug Plans (PDPs) are preparing for the biggest Part D changes in the program’s 18-year history. As plans consider how they’ll manage an increasing share of responsibility for catastrophic drug costs, sources say they await critical outstanding information, such as an updated Part D risk adjustment model and additional guidance on the Medicare Payment Prescription Plan.

“The Inflation Reduction Act of 2022 will be ushering in many benefit parameters that will need to be carefully included in planning for 2025,” observes Debra Devereaux, R.Ph., principal and chief pharmacy/clinical officer with Rebellis Group. For starters, the IRA eliminates the coverage gap (a.k.a. the “donut hole”) for seniors in 2025, and plans will be responsible for 60% of drug costs in the catastrophic phase of coverage, which is triggered when enrollees exceed a new $2,000 out-of-pocket cap. (Plans paid 15% of that share in 2023 and will pay 20% in 2024, while CMS will decrease its share from 80% to 20% in 2025, and manufacturer discounts will be introduced in the initial and catastrophic coverage phases.)

The approval of Eli Lilly and Co.’s Zepbound (tirzepatide) in November capped off a banner year for glucagon-like peptide 1 (GLP-1) agonists and their use in weight loss management. And the fuss over these much-hyped obesity drugs — originally approved to treat diabetes — is likely just beginning. While employer groups and commercial payers are agonizing over the potential cost of coverage, industry leaders and legislators are pushing for Medicare to cover GLP-1s as weight loss therapies. Medicaid programs, meanwhile, are also weighing their options.

GLP-1s are now “the No. 1 driver of non-specialty pharmacy trend,” Mercer’s lead pharmacy actuary Jon Lewis told AIS’s Health Plan Weekly in November. Zepbound joins fellow GLP-1s from Novo Nordisk A/S, Wegovy (semaglutide) and Saxenda (liraglutide), in the obesity market basket. (As diabetes therapies, Zepbound is marketed as Mounjaro, while Wegovy is known as Ozempic.) Despite crackdowns on off-label use of the drugs’ diabetes iterations and a seemingly endless wave of shortages, many in the industry are clamoring for increased consumer access to the drugs. The American Medical Association on Nov. 13 passed a resolution asking “health insurers to provide coverage of available FDA-approved weight-loss medications, including GLP-1 medications, to demonstrate a commitment to the health and well-being of our patients.”

If the recent activity of Humana Inc.’s private jet is any indication, The Cigna Group may have to compete with Walmart Inc. in its reported bid to combine with the Medicare Advantage-focused insurer.

That bit of corporate intrigue comes courtesy of Gordon Haskett Research Advisors, an investment brokerage that offers a service tracing the movements of major companies’ aircraft to “track possible signposts of M&A, strategic partnerships, activism, etc.”

Don Bilson, head of event-driven research at Gordon Haskett, wrote in a Dec. 1 post on X (formerly Twitter) that “Humana flew to Arkansas yesterday” — the same day the Wall Street Journal published a report, citing anonymous sources, that Cigna and Humana were discussing a deal to combine. “Could be harmless, but these two did talk in 2018,” Bilson said, referring to a WSJ report in March of that year indicating that Walmart was in “early-stage acquisition talks” with Humana. Walmart is based in Bentonville, Arkansas.

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.