Patients Deserve Better:

CMS Proposal Would Reduce Copay Assistance Programs and
Risk Patients’ Life-Line to Prescription Drug Access

On June 19, 2020, the Centers for Medicare & Medicaid Services (CMS) released a notice of proposed rulemaking that changes how pharmaceutical companies approach Medicaid Best Price and Average Manufacturer Price (AMP) reporting requirements.

This harmful policy shift puts at risk the life-line to drug affordability that patients need, especially those suffering from serious illness, chronic conditions, and disabilities — including the estimated 50 million Americans with an autoimmune disease. This comes at a time when COVID-19 is eroding jobs, personal finances and overall health for millions of families.

 

About the Proposed Rule

The rule as proposed would require companies to include the value of cost-sharing assistance when meeting Medicaid Best Price and AMP reporting requirements unless they can prove that 100 percent of patient assistance benefits the patient.

  • This is an impossible task since Pharmacy Benefit Managers (PBMs) and other insurance middlemen are not transparent and frequently pocket portions of rebates rather than passing them on to patients.
  • Ultimately, this rule could inadvertently reduce patient assistance programs and overall access to critical therapies for people who rely on them.

The burden of the change is further compounded by the recently finalized 2021 Notice of Benefits and Payment Parameters, which permits insurers and PBMs to exclude the value of cost-sharing assistance when calculating a patient’s out-of-pocket maximum.

  • In early March, AARDA led the effort to oppose the proposed rule and joined with 43 other organizations in sending a letter to the Administration and congressional leaders about the harmful impact of the proposed rule.
  • Despite considerable opposition, the U.S. Department of Health and Human Services decided to move forward with the rule. Its impact will be felt by millions of Americans who rely on various forms of financial assistance.
    • Policies that exclude certain types of assistance from counting towards patients’ annual limitation on cost sharing effectively increase patients’ out-of-pocket costs.
    • As a result, patients experience significant barriers to access and may lose their ability to adhere to prescribed treatment regimens. Patients’ inability to cover out-of-pocket costs can result in the foregoing of — or inability to access — reliable treatments, causing exacerbated conditions, irreparable damage, unnecessary suffering, and additional costs.
    • The rule is particularly harmful to patients with autoimmune and other chronic conditions who need highly personalized care from physicians who understand their unique health situations.

 

What happens next?

Both HHS rules present a troubling trend that further puts patients’ health and wellbeing at risk. As we continue to navigate the worldwide COVID-19 pandemic, patients should not be forced to shoulder the burden of increased costs and barriers to better care.

If the newly-proposed rule is implemented as it currently stands, the results will be devastating for patients at already high risk by:

  • Reducing the availability of cost-sharing assistance for individuals with commercial market insurance (i.e. employer-sponsored insurance, ACA marketplace plans, etc.), increasing costs for patients at the pharmacy.
  • Decreasing the adherence to prescription drug treatment, leading to deteriorating health outcomes during a global pandemic.

AARDA and its partners will not stand by as copay programs are upended and patients are once again forced to forego the assistance they would otherwise be entitled to. We will continue to lead the effort to raise awareness of this harmful, unnecessary policy shift and we invite you to join us in urging CMS to reverse course before it’s too late.

 

Your voice matters!

CMS has been accepting comments on the proposal through July 20, 2020. Please click here to be directed to the CMS comment portal. Thank you for sharing your story regarding how this rule would affect you or your loved ones, and why CMS needs to reconsider the provision in order to prevent damaging patient health.

It’s time to put patients first and preserve

critical access to medicines.