HIV+Hep in the News

The Biden administration has withdrawn its appeal of a district court ruling that provisions in the 2021 Notice of Benefit and Payment Parameters (NBPP) pertaining to copay accumulator programs are invalid. Judge John Bates in September had ruled in favor of patient advocates from the HIV +Hepatitis Policy Institute, Diabetes Patient Advocacy Coalition, Diabetes Leadership Council and other groups. In late December, Bates clarified that his ruling means the 2020 NBPP is now in effect and copay accumulator programs can only be used for drugs that have generic or biosimilar alternatives. Still, until its latest filing, HHS was still challenging Bates’ ruling in court. “We are pleased that the government has withdrawn its appeal of our court victory for patients who struggle to afford their prescription drugs and rely on copay assistance,” Carl Schmid, executive director of the HIV +Hepatitis Policy Institute, said in a statement. “Now, insurers must heed the court ruling by ending their cruel policy of collecting copay assistance and not applying it to patients’ cost-sharing obligations.”

Clarification of the September ruling and next steps by the U.S. Department of Health and Human Services are needed, said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, a plaintiff in the case, along with Diabetes Leadership Council and the Diabetes Patient Advocacy Coalition. “We really want an enforcement and clarification guidance,” he said in an interview. “We need to know whether the government is going to enforce the 2020 rule. The judge in the lower court in 2021 didn’t rule on the regulatory definition of cost sharing. What he ruled is that insurers can’t have two different definitions. He ruled that the insurers applied the accumulators in a way that was ‘arbitrary and capricious.’”

Insurers will have to count drug copay coupons toward deductibles and patient spending caps in most cases, after a Biden move in federal court on Tuesday. Drug companies use copay coupons to help patients cover the cost of their drugs.

The Biden administration and advocacy groups agreed to end a government appeal of a D.C. federal judge’s decision to vacate a 2021 rule that allowed insurers to not count coupons or discounts provided by pharmaceutical companies to patients toward patients’ deductibles and out-of-pocket maximums.

The government has agreed to drop its appeal of a D.C. federal district court decision permitting the use of copay accumulator adjustment programs to help patients pay for their medicines. The Justice Department on Tuesday moved to withdraw its appeal of a recent decision by the US District Court for the District of Columbia in a case brought by the HIV & Hepatitis Policy Institute, overturning a Trump administration rule that allowed health insurers to avoid counting drug manufacturer copay assistance towards beneficiaries’ annual limits on deductible and out-of-pocket costs.