RISE summarizes recent regulatory-related headlines.
CMS proposes Medicare drug model featuring $2 generic drugs
The Centers for Medicare & Medicaid Services (CMS) is seeking feedback on its proposed Medicare $2 Drug List Model and the sample list of drugs that will cost $2.
The model aims to test whether offering low-cost, clinically important generic drugs can improve medication adherence, lead to better health outcomes, and improve satisfaction with the Medicare prescription drug coverage (Part D) benefit.
Under the model, people enrolled in a participating Part D plan would have access to these drugs for a low, fixed copayment of no more than $2 for a month’s supply per drug. CMS said in the announcement that the model will provide enrollees with more certainty about the out-of-pocket costs for these generic covered Part D drugs that would target common conditions, such as high cholesterol and high blood pressure.
“The initial version of the $2 Drug List represents a starting point for the drug list that would be included in the model,” said Liz Fowler, CMS deputy administrator and director of the Center for Medicare and Medicaid Innovation Center. “CMS intends to include many drugs that are used to treat common conditions for people with Medicare, with periodic updates to the drug list once it is finalized.”
Comments on the proposal mut be submitted by December 9. For more information, click here.
HHS outlines steps to address health impacts of Hurricane Helene
In a letter to health care leaders on Tuesday, Department of Health and Human Services Secretary Xavier Becerra outlined the steps the department is taking to mitigate disruptions in the supply chain due to the storm and prevent further disruptions as a result of Hurricane Milton.
Becerra said that prior to Hurricane Helene, there was already a shortage of normal saline IV fluids, normal saline irrigation fluid, sterile water irrigation, and dextrose 5% IV fluids. The hurricane has led to disruptions at the Baxter facility in Marion, N.C. that provides a significant portion of IV solutions, irrigation fluids, and peritoneal solutions to the U.S. medical system.
However, he said compounding of drugs on the U.S. Food and Drug Administration (FDA) shortage list can be done in accordance with current requirements to help alleviate shortages. While the supply is constrained, Baxter has said that they resumed shipments to hospitals and dialysis providers and patients after the temporary hold last week. The inventory will be used to support current allocations in the short term, and several of their global plants are scaling and ramping production to help meet U.S. needs.
Becerra said HHS is coordinating a government-wide response to address the supply chain disruptions. It’s also working with public and private partners to support the supply chain while the Baxter facility is brought back to full operational capacity. The FDA is working with Baxter to identify potential products already in their system and alternative manufacturing sites, including for potential temporary imports. The FDA will also expedite consideration of any shelf-life extension requests manufacturers submit for short-dated product.
In addition, the Administration for Strategic Preparedness and Response (ASPR) is working to support infrastructure repairs and ensure the facility can resume operations as quickly as possible. As a result of these efforts, Baxter does intend to increase allocations to their customers in the coming week. ASPR is also providing technical assistance and support to increase manufacturing at other domestic sites where possible. As a result of this work with other domestic IV solutions manufacturers, ASPR has identified the possibility of Hurricane Milton further disrupting an already fragile market. Becerra said ASPR is currently pre-deploying assets to prepare broadly for the impacts of Hurricane Milton and working to move products away from the projected path of the storm.
“We understand these circumstances are hard for many providers and health care systems and we ask for your partnership at this critical time,” Becerra said. “HHS is encouraging manufacturers, wholesalers, and distributors to evaluate product allocation and health care providers to implement product conservation strategies to maintain safe, quality patient care and maximize available supply. HHS is encouraging all providers and health systems, regardless of whether they have experienced a disruption in their supply, to take measures to conserve these critical products.”
KFF survey: Annual premiums for employer coverage rises 7% in 2024
Family premiums for employer-sponsored health insurance rose seven percent this year to reach an average of $25,572 annually, according to KFF’s 2024 Benchmark Employer Health Survey, which polled 2,100 large and small employers. On average, workers contribute $6,296 annually to the cost of family coverage.
This marks the second year in a row that premiums are up seven percent, KFF said in the announcement. Over the past five years—a period of high inflation (23 percent) and wage growth (28 percent)—the cumulative increase in premiums has been similar (24 percent).
While employers are seeing total premiums for family coverage rise steadily, the amount that workers, on average, pay toward their annual premiums is little changed over the past five years—up less than $300 since 2019, or a total of five percent over five years. This may be due to a tight labor market, KFF said.
Among workers who face an annual deductible for single coverage, the average this year is $1,787, similar to last year’s $1,735 and up eight percent since 2019 when the average was $1,655.
On average, workers with a deductible at small firms (under 200 workers) face much larger deductibles than workers at larger firms ($2,575 vs. $1,538). Among all covered workers, a third (32 percent) of covered workers at smaller firms face an average single deductible of at least $3,000.
“Employers are shelling out the equivalent of buying an economy car for every worker every year to pay for family coverage,” KFF President and CEO Drew Altman said in the announcement. “In the tight labor market in recent years, they have not been able to continue offloading costs onto workers who are already struggling with health care bills.”
The survey finds that some of the nation’s largest employers (at least 5,000 workers) are taking steps to shield lower-wage workers from the full impact of rising health care costs. Of these jumbo firms, 29 percent say they have a program to reduce lower-wage workers’ premiums, and 19 percent say they offer a reduced-benefit plan with more affordable coverage.