HIV+Hep in the News

CMS & HHS withdraw appeal to recent copay accumulator federal district court decision: 2020 accumulator rule still in effect

On January 16, the Centers for Medicare & Medicaid Services (CMS) & the U.S. Department of Health and Human Services (HHS) withdrew an appeal to a recent copay accumulator court decision, HIV+Hepatitis Policy Institute et al. v. United States Department of Health and Human Services, in the U.S. District Court for the District of Columbia (Court). The appeal had originally been filed in the case brought by patient advocates against CMS and HHS seeking to set aside the Court’s order after the Court held that the 2021 HHS rule giving insurers discretion to operate accumulator adjustment programs (Accumulator Adjustment Programs) was arbitrary and capricious. With this turnabout by the Biden administration, the 2020 Accumulator Rule is still in effect, which permits insurance plans to exclude only the value of manufacturer assistance from annual out-of-pocket cost-sharing maximum calculations for brand prescription drugs with an available and medically appropriate generic equivalent.

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Deductible costs can’t be counted against patients. But will health plans comply?

“We are pleased that the government has withdrawn its appeal of our court victory for patients who struggle to afford their prescription drugs and rely on copay assistance,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. “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.”

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Biden administration concedes to court on copay accumulators

With little fanfare, the Biden administration dropped its appeal Jan. 16 of a recent court decision that vacated a 2021 U.S. Health and Human Services rule permitting health insurance issuers and group health plans to use so-called copay accumulator adjustment programs that prevent drug manufacturers’ copay assistance from counting toward a patient’s deductible or out-of-pocket maximum.

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Biden White House drops appeal in co-pay assistance case

“We are pleased that the government has withdrawn its appeal of our court victory for patients who struggle to afford their prescription drugs and rely on copay assistance,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, one of the plaintiffs in the lawsuit, in a press release. “Now, insurers must heed the court ruling by ending their cruel policy of collecting co-pay assistance and not applying it to patients’ cost-sharing obligations.”

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HHS drops appeal in drug coupon case

On January 16, 2023, the Department of Health and Human Services (“HHS”) dropped its appeal of the U.S. District Court for the District of Columbia’s September 29, 2023 decision that vacated a portion of the 2021 Notice of Benefit and Payment Parameters (“2021 NBPP”). The 2021 NBPP permitted (but did not require) plans and issuers to count direct support offered by drug manufacturers for prescription drugs (“Coupons”) toward the Affordable Care Act’s annual cost-sharing limit (“MOOP”). HIV and Hepatitis Policy Inst. et al. v. U.S. Dep’t of Health and Hum. Svcs., No. 22-2604, 2023 WL 6388932 (D.D.C. Sept. 29, 2023).

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