Biden admin finalizes rule that requires insurers to submit data on drug costs, rebates

The Biden administration has issued an interim final rule that requires private insurers to report prescription drug costs to the federal government.

The interim rule, which also includes a request for comment, is the latest in a series of regulations implementing provisions of the No Surprises Act and the Consolidated Appropriations Act of 2021. Insurers providing employer-sponsored coverage, other group plans or individual plans must submit key data on drug costs to the departments of Health and Human Services (HHS), Labor and Treasury.

The data will then be used by HHS' Assistant Secretary for Planning and Evaluation to publish a report on drug pricing trends and rebates along with their impact on insurance premiums and consumers' out-of-pocket costs, according to an announcement from the Centers for Medicare & Medicaid Services (CMS).

Data submission must start with information from the 2020 calendar year, but the agencies will defer enforcement until Dec. 27, 2022, to allow insurers to come into compliance.

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Data from 2020 and 2021 will be due on that date, CMS said, though insurers can submit them sooner. The agency said it expects to release its first report in June 2023 and then biennially.

“Life-saving prescription drugs should not cost anyone their life savings,” said HHS Secretary Xavier Becerra in a statement. “Today the Biden-Harris Administration is taking additional steps to make health care more accessible and affordable for patients."

"By collecting key data on the costs of prescription drugs, we are promoting competition and transparency in the health care industry as we continue to curb the rising costs of drugs and surprise medical bills," Becerra said.

A fact sheet on the rule lays out more specifics on the required data. Each year, insurers will be asked to provide information such as the 50 most frequently dispensed brand drugs, the 50 costliest drugs based on total spending and the 50 drugs with the largest increase in plan or coverage expenditures year over year.

Insurers will also be required to submit data on rebates, fees and other remuneration paid by drug companies to the plan in each therapeutic class, as well as the 25 products that yielded the highest amount of rebates. They must also include information on the impact rebates have on premiums and out-of-pocket costs, according to the fact sheet.

“With today’s rule, we’re taking more steps to make sure that the care people receive is affordable,” said CMS Administrator Chiquita Brooks-LaSure in a statement. “Expanding on our earlier efforts to implement the No Surprises Act, we will monitor pricing and premium trends to better identify barriers to the low-cost, comprehensive, and person-centered care we all deserve.”

Comments on the interim final rule are due Jan. 24, 2022.