Medicare Part B

Eisai Co., Ltd. and Biogen Inc.’s Leqembi (lecanemab) could raise Medicare Part B spending by $8.9 billion or more annually if it receives full approval from the FDA KFF found. And a report by researchers from the RAND Corp. found that Leqembi could increase spending by $2 billion to $5 billion. KFF’s projection was based on an annual list price of $26,500 and uptake among 5% of Alzheimer’s patients. The RAND report included estimates of ancillary costs, such as MRI scans. The FDA granted accelerated approval to the anti-amyloid monoclonal antibody treatment in January, and its decision on full approval is expected soon.

CVS Health Corp is shutting down its clinical trials division, which launched in 2021, and will conclude operations in 2024. The division has worked with more than 30 drugmakers on 50 Phase I, II and IV studies involving 33,000 participants, according to Modern Healthcare.

As CMS continues to tighten oversight of misleading marketing activities, the agency will soon require Medicare Advantage organizations to file all materials that mention any type of benefit. In a May 10 memo from the Medicare Drug & Health Plan Contract Administration Group, CMS explained that while it previously interpreted the mentioning of widely available benefits (e.g., vision, dental, premium reductions) as “general descriptions” that were not “made with sufficient intent to draw attention to a particular plan or subset of plans” and lead to an enrollment decision “without information on the associated costs for enrollees,” complaints received through various channels have indicated otherwise. Therefore, CMS is expanding its interpretation of “marketing” to “include content that mentions any type of benefit covered by the plan and is intended to draw a beneficiary’s attention to plan or plans, influence a beneficiary’s decision-making process when selecting a plan, or influence a beneficiary’s decision to stay enrolled in a plan (that is, retention-based marketing) and thus subject to review.” As such, the agency will require any material or activity that is distributed by any means and mentions any benefit to be submitted into the Health Plan Management System effective July 10.

A Senate Finance Committee “secret shopper” investigation of Medicare Advantage plan provider directories turned up inaccurate, nonworking phone numbers or unreturned calls in 33% of 120 provider listings. Staff reviewed directories of 12 different plans in a total of six states and called 10 systematically selected providers from each plan for a total of 120 calls, according to the May 3 report. Furthermore, more than 80% of the supposedly in-network mental health providers that were contacted by reviewers were unreachable, not accepting new patients or out of network. In remarks given at a May 3 hearing to discuss the issue, Committee Chairman Ron Wyden (D-Ore.) called these so-called ghost networks a “breach of contract” by health insurers and vowed to “use all resources” at his disposal to “get some real accountability.” When insurers host such ghost networks, “they are selling health coverage under false pretenses, because the mental health providers advertised in their plan directories aren’t picking up the phone or taking new patients,” he stated. “In any other business, if a product or service doesn’t meet expectations, consumers can ask for a refund.” He also pointed out that CMS performs regular audits of MA plans to ensure that they meet minimum standards but does not routinely audit MA provider directories. "[T]he results speak for themselves. It’s time for that to change," he added.

UnitedHealth Group on April 14 said revenue for the first quarter of 2023 rose 15% from the prior year to $92 billion, reflecting double-digit growth at both Optum and UnitedHealthcare. The insurance segment, which served about 1.2 million more people in the first three months of the year with broad-based growth across its commercial, Medicare and Medicaid lines of business, saw revenues climb 13% to $70.5 billion, according to the company’s earnings press release. And the insurer said it expects to “exceed the upper end” of its Medicare Advantage membership growth expectations for the year. The company stated in November that it anticipated adding between 800,000 and 900,000 new MA members in 2023. As of March 31, the company served more than 7.54 million MA enrollees, compared with 6.89 million a year ago. UnitedHealth recorded first-quarter adjusted earnings per share of $6.26, an increase of 14% from first quarter 2022, and raised its full-year adjusted EPS outlook to between $24.50 and $25.00. During an April 14 conference call to discuss first quarter earnings, CEO Andrew Witty commended CMS for deciding to phase in changes to the MA risk adjustment system. “The phase-in will allow for more time to minimize impacts on beneficiaries as we lean on the multiple levers available to us, including our ability to manage costs and our relentless focus on member and patient needs,” he stated, according to a transcript of the call from The Motley Fool.

CMS on March 15 revealed the first drugs that will be sanctioned for having their prices increase faster than the rate of inflation, as part of the Inflation Reduction Act. The 27 medications are all covered under Medicare Part B, and many of them are treatments for cancer, chronic kidney disease and the aftereffects of organ transplants. Beneficiaries who normally pay 20% coinsurance under Part B will see their share decline based on an inflation-adjusted price for these drugs.

The federal government will invoice the manufacturers for 2023 and 2024 Part B inflation rebates no later than fall 2025, and those funds will be deposited into the Medicare Trust Fund. A Kaiser Family Foundation analysis found that, from 2019 to 2020, half of all drugs covered by Medicare had price increases above the rate of inflation over that period.

Medicare Advantage enrollment over the last year grew by 7.4%, reflecting slower growth than previous years and falling slightly below CMS’s expectations. According to the latest update to AIS’s Directory of Health Plans (DHP), the MA program enrolled nearly 31 million beneficiaries as of February. That data reflects the full outcome of the 2023 Medicare Annual Election Period (AEP), which ran from Oct. 15 through Dec. 7. Despite the slowdown in enrollment, insurers’ increased investments in Special Needs Plans (SNPs) appear to be paying off, while MA plans say their attempts to maintain affordability while enriching benefits contributed to their AEP successes.

“We are basically at the very tail end of the Baby Boomers aging into Medicare as of 2023,” remarks Rebellis Group CEO Betsy Seals, referring to the generational group whose births peaked in 1958. “Looking at the overall numbers, I think that we have a lot yet to discover about this next generation and how they’re going to shop and switch and enroll. So that’s going to be interesting.”

The Biden administration on Feb. 9 released the first round of guidance regarding the Medicare prescription drug inflation rebate program that’s included in the Inflation Reduction Act (IRA), which requires drugmakers to pay rebates to Medicare if they raise the price of drugs faster than the rate of inflation. One expert tells AIS Health, a division of MMIT, that the rebates should have minimal effects, if any, on premiums for Medicare Advantage (MA) plans with prescription drug coverage and stand-alone Prescription Drug Plans (PDPs), given the information that is currently available — although she observes that drugmakers may try to recoup their losses through more aggressive commercial plan rebate strategies.

The rebate program has already begun to phase in: Medicare prescription drug transactions starting in October 2022 are subject to rebates for both Part B and Part D drugs. However, CMS has yet to produce the regulations that will govern the rebate process.

In response to an executive order issued last fall, HHS recently unveiled three new prescription drug pricing models that it wants the CMS Innovation Center to test. The models — which target low-cost generics, cell and gene therapies and drugs that received accelerated approval — are likely to diverge considerably when it comes to industry reception and likelihood of speedy implementation, experts say.

“One of the things I really like about the three models that have been proposed is that they touch on really different aspects of affordability and access, and different programs that CMS oversees,” says Stacie Dusetzina, Ph.D., a health policy professor at the Vanderbilt University School of Medicine. “So it was encouraging to me to see, for example, a model that was focused on gene and cell therapies and Medicaid programs, in addition to two very different groups within the Medicare programs: one being high-cost drugs approved through accelerated approval, and the other being drugs that we typically think of as being low-cost, but that maybe we could be...making more affordable to seniors — including high-value generic drugs offered on Part D.”

On Sept. 1, CMS will publish its list of 10 Medicare Part D drugs that it has chosen for negotiations for 2026, the first year that negotiated prices will be in effect via the Inflation Reduction Act (IRA). But a lot of unknowns exist around the law, including how CMS will determine the drugs up for negotiation. During an Evercore ISI webinar held Jan. 30, analysts broke down this aspect of the IRA and shared the drugs and manufacturers they expect to be impacted.

“We are looking at an escalating number of drugs subject to negotiation starting in 2026,” noted Tobin Marcus, policy analyst at Evercore ISI. “There’s been some misunderstanding about the fact that these numbers are cumulative.” So while 2026 will have 10 drugs up for negotiation, 2027 will have an additional 15 Part D drugs for a total of 25 for the year. The following year will see an additional 15 Part D and Part B drugs, and then starting in 2029 and later years, 20 more Part D and Part B agents will be up for negotiation.

The Inflation Reduction Act (IRA) will allow Medicare to negotiate prescription drug prices, starting with a limited set of therapies in 2026. But while some aspects of the law are clear, some uncertainties around others exist. Biopharma companies need to start preparing as much as they can for some of the challenging situations that may arise, recommends one industry expert.

Josh Schimmer, an analyst at Evercore ISI, pointed out during a Nov. 17 webinar hosted by his company that the IRA has “many, many moving parts, some of which are…really quirky, some of which seem a little unsustainable in terms of the dynamic that they might have. It’s going to impact so many companies in this industry sooner or later; some might be spared. But those are probably going to be smaller companies. So the bigger you are, the more likely you are at some point to have to face the IRA.”