Patients struggling with the high cost of health insurance can expect even higher out-of-pocket costs in 2021, under an insurance regulation proposed by the Centers for Medicare & Medicaid Services.

Last month, the obscure federal agency under the Department of Health and Human Services released the “Notice of Benefit and Payment Parameters Rule for 2021,” an annual set of proposed regulations governing health insurance plans. Under the proposed CMS regulations, insurance companies could completely ignore copay assistance programs when calculating out-of-pocket costs of deductibles, coinsurances, and copays.

copay accumulator program“We propose to interpret the definition of cost-sharing not to include expenditures covered by drug manufacturer coupons,” the notice states.

Patient advocates say that regulatory language is a devastating change to how insurance companies calculate a patient’s out-of-pocket costs and give a green light to what’s become known within the healthcare sector as copay accumulator programs.

“This loophole will allow insurance companies to dramatically increase patients’ out-of-pocket in 2021,” explains Terry Wilcox, executive director of Patients Rising, a national patient advocacy non-profit organization that helps patients overcome insurance barriers to access.

Co-Pay Assistance Programs Reduce Patient Out-of-Pocket Costs

Co-pay assistance programs, commonly known as a copay card, copay coupon, or copay savings program, provide a vital lifeline to patients struggling with high out-of-pocket insurance costs. With co-pay assistance programs, a church, charity, or even pharmaceutical manufacturer cover a portion of a patient’s co-pay.

Every year, co-pay assistance programs provide billions of dollars of critical financial support to patients in need. In 2015, patient assistance programs provided $5.7 billion in charitable support to help patients access life-saving medical care – more than the charitable giving of the Bill & Melinda Gates Foundation over the same period.

Patient Assistance Programs

Source: LA Times

“Patient assistance programs are absolutely critical,” says Wilcox of Patients Rising,

Approximately one in five prescriptions in the United States were filled using copay coupons in 2016. More than half of rheumatoid arthritis access their treatments with the help of copay coupons, according to Stanford University research.

The insurance rule change proposed by CMS would be especially harmful to patients living with chronic conditions, rare diseases or other conditions for which there are no generic treatments available.

“Not only will it increase patients’ costs, but it will translate in insurance companies collecting even more money off prescription drugs,” says Carl Schmid, the former deputy executive director of the AIDS Institute, who now works with the HIV + Hepatitis Policy Institute. “We urge HHS not to finalize such an anti-patient proposal.”

CMS Contradicts Trump Directive to Lower Patient Costs

The proposal by administrators at the Centers for Medicare & Medicaid Services contradicts President Trump’s directive for federal agencies to find ways to reduce the financial burdens of health care facing millions of middle-class American families.

“This will make it significantly more difficult for patients to meet their annual deductibles,” warns Dr. Michael C. Schweitz, MD. “As more and more patients move into high-deductible health plans, this concern is exacerbated.”

The anti-patient regulatory change was absent from the federal agency’s press release and instead was buried in the 245-page Proposed 2021 Payment Notice.

Federal regulatory guidelines require CMS to accept public comments on the proposed insurance rules until March 2, 2020.

Patient Action Alert: Save Copay Assistance Programs

Patients Rising NOW is mobilizing a patient advocacy campaign to urge CMS to protect copay assistance programs. Take action here and urge CMS to protect patients!

I support copay assistance programs, which reduce patients’ out-of-pocket health care costs.


The Centers for Medicare & Medicaid Services should adopt insurance regulations that support patients. All types of copays should count towards a patient’s annual limitation on cost-sharing, including drug manufacturer coupons.


I urge CMS to remove the insurance copay accumulator loophole in “Notice of Benefit and Payment Parameters Rule for 2021, § 156.130 Cost-sharing requirements.”