People living with chronic and serious medical conditions face high medical bills. Many rely on co-pay assistance programs from drug manufacturers to help them afford their meds, even if they are taking generic versions. A proposed rule by the Centers for Medicare & Medicaid Services (CMS) would limit the use of those programs as they apply to out-of-pocket costs for generics. In objection, 87 organizations from the I Am Essential patient advocacy coalition sent a letter to the CMS administrator in which they laid out their concerns regarding the changes. The groups that signed the letter advocate for those with a vast array of medical conditions, including cancer, HIV/AIDS, autism, hepatitis C, epilepsy, hemophilia and lupus.

According to a press release from I Am Essential, under the proposed changes, insurance companies would be allowed to:

  • Prohibit the use of co-pay assistance for the purchase of brand-name drugs when a generic is available

  • Not count patient spending on brand-name drugs when a generic drug is available

  • Remove brand-name drugs from formulary midyear when a generic becomes available.

These proposals are problematic, the coalition writes, because generic drugs are not always a low-cost option and because many insurance plans include high deductibles.

“People with complex, expensive acute and chronic health conditions depend on manufacturer assistance to help pay for high out-of-pocket costs, which can reach as high as $7,900 for an individual or $15,800 for a family,” Carl Schmid of The AIDS Institute, one of the cosigners of the letter, said in the press release. “Due to proliferation of high-deductible plans, just because a generic is available doesn’t mean that it’s affordable.”

Laura Weidner of the Epilepsy Foundation explained why I Am Essential opposes allowing midyear formulary changes and the discontinuation of coverage if a generic is approved. “People sign up for a plan based on the drugs on its formulary,” she said. Many conditions are highly individualized, and people respond to different drugs differently. Discontinuing coverage of a drug that a patient is stable on can lead to serious, life-altering or, in some cases, life-ending consequences.”

CMS is part of the federal Department of Health and Human Services Department. You can read the proposal on the website of Federal Register here. The I Am Essential press release is here, and you can read the group’s detailed 11-page letter to CMS here.