The rule requires health plans, and other group health plans to submit key data to the federal government that will be used for a report on prescription drug pricing trends and rebates, as well as their impact on premiums and drug spending for patients, compared to their employers and/or group health plans/health insurance issuers.
The interim final rule, which was released Wednesday and is scheduled to be published on Nov. 23 in the Federal Register, is the fourth rule in a series that the Departments of Health and Human Services (HHS), Labor, the Treasury, and the Office of Personnel Management are issuing to implement the No Surprises Act and transparency requirements of the Consolidated Appropriations Act (CAA), 2021.
It requires health plans, health insurance issuers offering group or individual health insurance coverage, and health benefits plans offered to federal employees to submit key data to HHS, Labor, and the Treasury, which will work through the HHS Assistant Secretary for Planning and Evaluation to publish a report on prescription drug pricing trends and rebates, as well as their impact on premiums and consumers’ out-of-pocket costs. The data submission requirements include information on average monthly premiums and drug spending for patients compared to their employers and/or group health plans/health insurance issuers.
Since prescription drugs account for a significant portion of health care spending, the interim final rule also implements unique requirements to identify specific cost drivers. Plans and issuers must now provide HHS, Labor, and the Treasury, with an annual overview of their top 50 drugs across key areas of concern, including:
- the most frequently dispensed brand prescription drugs
- the costliest prescription drugs
- the prescription drugs that had the greatest increase in total annual plan spending over the previous year
Additional information on prescription drug rebates, fees, and other remunerations paid by drug manufacturers to plans, issuers, and pharmacy benefit managers—including the top 25 drugs generating the highest rebate amounts—will help HHS, Labor, and the Treasury understand and report on prescription drug costs and how they fluctuate over time.
“Life-saving prescription drugs should not cost anyone their life savings,” HHS Secretary Xavier Becerra said in an announcement about the interim final rule. “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.”
CMS Administrator Chiquita Brooks-LaSure said the rule will allow the agency to take more steps to ensure that the care people receive is affordable. “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,” she said.
A CMS fact sheet contains additional details about data submission requirements—including how data will be collected and analyzed. The new data submission requirements will apply starting with data from the 2020 calendar year. However, enforcement of the new requirements won’t begin until December 27, 2022 to give regulated entities time to come into compliance. This means the required information for 2020 and 2021 is due by December 27, 2022, although it may be submitted sooner. HHS, Labor, and the Treasury anticipate releasing their first report in June 2023 and biennially thereafter.
Comments on the interim final rule will be accepted through 5 p.m. January 24, 2022.