Marshall and Kaine Lead Colleagues In Bipartisan Push To Lower Prescription Drug Costs

Washington, D.C. – U.S. Senators Roger Marshall, M.D. and Tim Kaine (D-VA), members of the Senate Health, Education, Labor, and Pensions (HELP) Committee, led a bipartisan letter urging the Department of Health and Human Services (HHS), the Department of Labor (DOL), and the Department of the Treasury to lower out-of-pocket costs for prescription drugs by enforcing a rule limiting the use of harmful “copay accumulators.” Copay accumulators prevent copay assistance from counting towards a patient’s deductible or out-of-pocket maximum, which makes it harder for patients to afford their medications. 

Regarding a recent court ruling limiting the use of copay accumulators, the members said, “This decision is an important step in the right direction for low-income and other eligible patients who rely on manufacturer and nonprofit copay assistance programs to alleviate affordability and access challenges for their medicines.”

The lawmakers wrote, “Instead of appealing the court’s ruling, we urge you to adopt policies from the 2020 NBPP [Notice of Benefit and Payment Parameters] that strike the right balance of preserving a plan’s ability to control costs while also putting the patient first.”

In the letter, the senators also push for their Help Ensure Lower Patient (HELP) Copays Act to permanently prohibit the use of copay accumulators and require health plans and Pharmacy Benefit Managers (PBMs) to count the value of copay assistance towards a patient’s deductible or out-of-pocket maximum.  

“More patients than ever are reaching out to us because they’ve been negatively impacted by these programs,” said Anna Hyde, Vice President of Advocacy and Access for the Arthritis Foundation. “They are being caught in a financial bind because they can’t pay the full cost of their medications. Biologic medicines are expensive and there are no generic alternatives, so copay assistance is often a vital life line for them.” 

“Far too many of the 1 million Americans living with multiple sclerosis are unable to afford life-changing medications to reduce the number of relapses, delay the progression of disability, and limit new disease activity. The National Multiple Sclerosis Society is disappointed with the Biden Administration’s decision to appeal the court’s September 29th ruling and continue the use of copay accumulators that will negatively impact access to care. We urge the withdrawal of their recently filed appeal,” said Bari Talente, EVP, Advocacy & Healthcare Access, National MS Society.

“Too many rare-disease patients struggle to afford the therapies they need. Copay accumulator programs hurt the most vulnerable rare disease patients who rely on manufacturer copay assistance to afford their medications by dramatically increasing their cost-sharing liability. NORD supports the District Court’s decision to vacate portions of the 2021 NBPP Final Rule that permitted the use of copay accumulator programs, and we are grateful for the strong bipartisan and bicameral support for the HELP Copays Act which would cement this decision legislatively. NORD is grateful to Senator Marshall and Senator Kaine for spearheading this letter to HHS on this important issue and for their continued leadership in protecting rare disease patients,” said Peter Saltonstall, President and COE, National Organization for Rare Disorders (NORD).

“The NPF Patient Navigation Center is constantly fielding calls from people who can’t afford the medicine they have been prescribed because of copay accumulator practices, so we are clearly disappointed in the Administration’s move to appeal the decision of the U.S. District Court for the District of Columbia that would limit their use,” said Leah M. Howard, J.D., President and CEO of the National Psoriasis Foundation. “We join Senators Doc Marshall (R-KS) and Tim Kaine (D-VA), in urging the Administration to renew policies ensuring copay assistance is counted towards deductibles and out of pocket maximums.”

“The Biden Administration has made it a priority to make healthcare more accessible and affordable for Americans. HHS can do just that – make necessary and lifesaving treatments more accessible and affordable for the most vulnerable Americans, those with rare and serious, chronic illnesses. Senators Marshall and Kaine, have led the way in Congress by centering patients in the discussion on healthcare access. We encourage HHS to follow suit, align with the Administration’s priorities, and enforce the 2020 NBPP. Now is the time to do right by patients!” said the AIDS Institute.

“While serving a million people impacted by cancer each year, we at the Cancer Support Community have witnessed the adverse effects of copay accumulator adjustment programs (AAPs) on patients’ ability to access life-saving medications. CSC strongly opposes the use of AAPs and supports the adoption of the 2020 NBPP policy, protecting affordability and access to care for under-resourced patients who rely on manufacturer copay assistance programs. We are grateful to have leaders that share our commitment to breaking down barriers and improving healthcare for all,” said the Cancer Support Community.

In addition to Marshall and Kaine, the letter is signed by Senators Joni Ernst (R-IA), Ed Markey (D-MA), Lisa Murkowski (R-AK), Elizabeth Warren (D-MA), Ted Budd (R-NC), Kirsten Gillibrand (D-NY), Shelley Moore Capito (R-WV), Cory Booker (D-NJ), Thom Tillis (R-NC), Chris Coons (D-DE), Mike Rounds (R-SD), Chris Van Hollen (D-MD), John Boozman (R-AR), Jeanne Shaheen (D-NH), Susan Collins (R-ME), Mazie Hirono (D-HI), and Kyrsten Sinema (I-AZ).

Full text of the letter is available here and below: 

Dear Secretary Becerra, Acting Secretary Su, and Secretary Yellen:

We are writing in support of the recent decision from the U.S. District Court for the District of Columbia that vacated the 2021 Notice of Benefit and Payment Parameters (NBPP) Final Rule provision that permitted the use of copay accumulator adjustment programs (AAPs) and remanded to the U.S. Department of Health and Human Services (HHS) to interpret the definition of “cost-sharing.” This decision is an important step in the right direction for low-income and other eligible patients who rely on manufacturer and nonprofit copay assistance programs to alleviate affordability and access challenges for their medicines. We are disappointed in HHS’s decision to file a notice of appeal of the decision and HHS’s articulated intention to not take any enforcement action against health insurance issuers or health plans that fail to count copay assistance toward the patient’s maximum annual limitation on cost-sharing. Instead of appealing the court’s ruling, we urge you to adopt policies from the 2020 NBPP that strike the right balance of preserving a plan’s ability to control costs while also putting the patient first.

Patient assistance programs (PAPs) help low-income and vulnerable patients with complex conditions access life-saving medicine. Historically, these copay assistance programs counted toward the annual limitation on cost-sharing, and the policy was reaffirmed under the Affordable Care Act. The patient protection on cost-sharing provided patients and families with greater predictability and certainty about their maximum out-of-pocket exposure on an annual basis. It also helped improve patient adherence to their medication and overall health outcomes. For example, one study showed that reduced cost-sharing for cardiovascular medicines increased adherence and had a greater impact on reducing the risk of vascular events and medical costs among non-white patients.

In recent years, health plans, pharmacy benefit managers, and third-party administrators have used AAPs to help to control costs. However, like cost utilization management, AAPs can be used as a profit-seeking tactic. When HHS published the 2021 NBPP final rule, it permitted group health plans and health insurance issuers to use AAPs without limitation. The Administration believed this “open door” would not necessarily lead to an increased uptake of AAPs by PBMs, but they were wrong. These programs proliferated in the intervening years. Nearly two-thirds of individual health plans available on the ACA marketplace included AAPs. It was also estimated that of all commercial markets in 2021, 43% of covered lives were in commercial health plans that had implemented AAPs.

As a result of this policy change, patients in our home states suffered, facing financial hardship and barriers to their once-accessible life-saving medicine. In many cases, patients or their family members found out about the AAP not counting their assistance at the pharmacy counter. They were left embarrassed, anxious, and without recourse. A recent survey showed that between 25- 36% of respondents discontinued therapy when they received an unexpected high charge of over $1,500 during the plan year as a result of AAPs. For many chronic disease patients, discontinuation of therapy can lead to irreversible and in some cases life-threatening health consequences. Further, six in 10 said they would have extreme difficulty affording their treatments without copay assistance programs being applied to their cost-sharing. Moreover, recent research has shown that non-white patients are 31% more likely to be exposed to an AAP than white patients. It was for these reasons, and more, that patient groups took action against the 2021 NBPP. Patients were not the only stakeholder to respond. State regulators have passed and are in the process of passing legislation. To date, 19 states, the District of Columbia, and Puerto Rico have banned or limited the use of AAPs.

As you consider next steps, we strongly encourage you to support patients by reconsidering your appeal of the court’s ruling and instead adopting the 2020 NBPP policy. It required plans to count manufacturer copay assistance toward the annual limitation on cost-sharing for drugs that do not have a medically appropriate generic equivalent available. In the 2020 rule, HHS reasoned that it would be less likely that the manufacturer’s assistance would disincentivize a lower cost alternative and thereby distort the market. HHS itself acknowledged situations when a patient has been subject to significant out-of-pocket costs because the patient has not progressed through the deductible phase of the health plan due to AAPs not applying the value of the manufacturer-sponsored assistance to the patient’s deductible. HHS further noted that “when this happens, the patient may be forced to stop taking the drug, switch to an alternative offered by the plan, or pay the full bill for the non-formulary drug, none of which are patient-friendly, especially for those patients with rare and life-threatening conditions.”

We also strongly believe that federal legislative action is also needed to restore this vital patient protection. In fact, Congress is currently working on a bipartisan, bicameral basis to advance legislation to ensure copay assistance counts toward the patient’s maximum annual limitation on cost-sharing.

Thank you for your consideration of this request. We look forward to your reply and your plan to ensure patients receive cost-sharing protections.

Sincerely,