legislation & regulation

Drugs in the Medicare price negotiation process will be at a disadvantage in Part D plans because their lack of manufacturer rebates and discounts will mean lower profits for plans and more pressure on premiums relative to competitors.

The realization is more dreary news for products that end up in the crosshairs of the Inflation Reduction Act (IRA) pricing process, even though the law requires Part D plans to cover negotiated drugs. There is no requirement that plans put those products on a preferred formulary tier, nor are there limits on utilization management tools like prior authorization or step therapy that plans can impose.

When then-President Barack Obama signed the Affordable Care Act (ACA) into law on March 23, 2010, he established the 351(k) biosimilar pathway via the Biologics Price Competition and Innovation Act (BPCIA), which amended the Public Health Service (PHS) Act. Since then, the FDA has approved almost 50 biosimilars, with about one-fifth of those gaining interchangeable status. That distinction, however, has been increasingly under fire, most recently in President Biden’s fiscal year (FY) 2025 budget, which proposes eliminating the interchangeability designation entirely. That could help boost uptake of biosimilars, resulting in prescription drug savings, say some industry experts.

In contrast to the EU, whose European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) clarified in September 2022 that all biosimilars approved in the EU are interchangeable, the FDA has created two levels of biosimilars: biosimilars and interchangeable biosimilars.

After pushing for new limits on broker compensation and other changes to ensure seniors are guided to Medicare Advantage and Part D plans that best meet their needs, the Alliance of Community Health Plans (ACHP) on April 4 celebrated a victory with the release of CMS’s final rule making policy and technical changes for the 2025 plan year. ACHP, which represents provider-aligned, not-for-profit health plans, had spelled out its hopes for these policies in its broader “MA for Tomorrow” framework and provided Senate testimony on the impact of excessive “add-on” broker fees paid by larger plans. After CMS issued its final rule containing new marketing-related policies, AIS Health, a division of MMIT, spoke with ACHP’s executive vice president of public policy, Dan Jones, to learn more about the group’s position.

Medicaid managed care organizations’ compliance with mental health parity laws and regulations varies widely by state, according to an HHS Office of Inspector General (OIG) report and industry experts. The wide range and, in some cases, widespread noncompliance with parity laws will be the subject of possible new regulations in Medicaid managed care.

The OIG report is an early sign that the Biden administration intends to train its sights on state Medicaid agencies and their MCOs’ mental health parity compliance, which would follow several years of heightened scrutiny on commercial plans’ compliance with mental health and substance use disorder (SUD) parity rules. MCOs and states may squirm when they start their time in the hot seat: OIG found that in eight studied states, “states and their MCOs did not conduct required parity analyses…and all eight states may not have ensured that all services were delivered to MCO enrollees in compliance with [mental health]/SUD parity requirements.” OIG also pointed a finger at CMS, blaming the agency for not scrutinizing states’ enforcement of parity rules.

Amylyx Pharmaceuticals, Inc. said on April 4 that it was voluntarily discontinuing the marketing authorization for Relyvrio (sodium phenylbutyrate and taurursodiol) in the U.S. and in Canada, where it is known as Albrioza. As part of a restructuring, the company also is laying off about 70% of its workforce. The FDA approved the agent for the treatment of amyotrophic lateral sclerosis (ALS) on Sept. 29, 2022, based on data from a Phase II trial involving 137 people. But on March 8, the company revealed that its Phase III PHOENIX trial did not meet the prespecified primary or secondary endpoints. Prior to the drug’s approval, the FDA’s Peripheral and Central Nervous System Drugs Advisory committee found that the study did not provide substantial evidence that the therapy was effective, but during a second meeting in September reversed course in favor of approval. At the time of Relyvrio’s approval, Amylyx co-founder and co-CEO Justin Klee declared that “if the PHOENIX trial is not successful, we will do what's right for patients, which includes taking the drug voluntarily off the market.” The company will not allow any new prescriptions for the drug, but it will transition current patients who wish to remain on treatment with Relyvrio to a free drug program. Amylyx will present topline data from the PHOENIX trial at the American Academy of Neurology Annual Meeting in Denver on April 16.

The Big Three PBMs — UnitedHealth Group’s Optum Rx, CVS Health Corp.’s Caremark, and The Cigna Group’s Express Scripts — have opted to cover Perrigo Co.’s over-the-counter birth control pill, Opill (norgestrel), at no cost to members in most non-grandfathered commercial plans, according to one expert. That suggests they are taking proactive steps to comply with potential rulemaking that could require most health plans to cover Opill and other types of over-the-counter birth control without cost sharing.

“There has been pretty broad, in the industry, adoption of Opill to the ACA preventive list,” Cody Midlam, Pharm.D., tells AIS Health, a division of MMIT. Midlam is a director at the benefits consulting firm WTW. “If a drug is on that list, that is generally available at $0 cost share at the point of sale for members.”

While CMS has thus far declined to take action on companies using copayment accumulators, the agency is moving forward to prohibit the use of a similar type of program, it revealed in the final 2025 Notice of Benefit and Payment Parameters (NBPP). Still, the rule — at least at this point — applies only to certain plan sponsors, and it is unclear how manufacturer patient assistance ultimately will be treated.

Several years ago, health plans and PBMs began implementing copay accumulators to counter manufacturer copay assistance programs. A next-generation version of these tools known as copay maximizers soon followed.

Before these tools, manufacturer assistance would count toward beneficiaries’ annual out-of-pocket expenses. When those out-of-pocket maximums were reached, health plans would cover the remainder of members’ costs for the year.

Although a newly finalized health insurance regulation clocks in at 748 pages, it is missing something patient advocates have been eagerly hoping to see: language stating CMS will enforce a court ruling regarding the use of copay accumulator programs. Due to that omission, a patient advocacy group says it is once again exploring its legal options to curtail the practice in which payers prevent drug manufacturer coupons from applying toward patients’ out-of-pocket cost obligations.

Patients and advocacy groups for years have filed official comments on the annual Notice of Benefit and Payment Parameters (NBPP), urging federal officials to curtail the use of copay accumulator programs, according to Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. “And every year, they’ve completely ignored those comments,” he tells AIS Health, a division of MMIT.

A 2022 New Mexico law eliminating in-network mental health and substance use disorder (SUD) treatment copayments, coinsurances and deductibles in plans regulated by the state led to a significant decline in out-of-pocket spending for prescriptions treating those conditions, according to a recent JAMA Health Forum study. However, early results showed that the number of prescriptions dispensed did not change in the six months after New Mexico’s No Behavioral Cost-Sharing (NCS) rule went into effect.

Samantha J. Harris, Ph.D., one of the study’s authors, tells AIS Health that the NCS is “really groundbreaking” in that it’s the first state law to eliminate cost-sharing for mental health and SUD treatments. She adds that “as people are looking at the next frontier of mental health or health care financing, this is an exciting policy option,” although she notes that “it remains to be seen whether it’s going to impact utilization of services [and] whether this is going to improve overall health and well-being.”

When then-President Barack Obama signed the Affordable Care Act (ACA) into law on March 23, 2010, he established the 351(k) biosimilar pathway via the Biologics Price Competition and Innovation Act (BPCIA), which amended the Public Health Service (PHS) Act. Since then, the FDA has approved almost 50 biosimilars, with nearly one fifth of those gaining interchangeable status. That distinction, however, has been increasingly under fire, most recently in President Biden’s fiscal year (FY) 2025 budget, which proposes eliminating the interchangeability designation entirely. That could help boost uptake of biosimilars, resulting in prescription drug savings, say some industry experts.

In contrast to the EU, whose European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) clarified in September 2022 that all biosimilars approved in the EU are interchangeable, the FDA has created two levels of biosimilars: biosimilars and interchangeable biosimilars.