Nov 17 -- The Department of Health and Human Services (HHS), together with the Department of Labor (DOL) and the Department of the Treasury (collectively, the Departments), as well as the Office of Personnel Management (OPM), released an interim final rule with request for comments (IFC), entitled “Prescription Drug and Health Care Spending.” This IFC is required under section 204 of Title II (Transparency) of Division BB of the Consolidated Appropriations Act, 2021 (CAA), and implements new requirements for health plans and health insurance issuers in the group and individual markets to submit to the Departments certain information about prescription drug and health care spending. The same information will be submitted by Federal Employees Health Benefits (FEHB) Program carriers in coordination with OPM. The Departments will issue biennial public reports on prescription drug pricing trends and the impact of prescription drug costs on premiums and out-of-pocket costs starting in 2023. These reports are expected to enhance transparency and shed light on how prescription drugs contribute to the growth of health care spending and the cost of health coverage.
This IFC requires plans and issuers in the group and individual markets to submit certain information on prescription drug and other health care spending to the Departments annually, including:
General information regarding the plan or coverage;
Enrollment and premium information, including average monthly premiums paid by employees versus employers;
Total health care spending, broken down by type of cost (hospital care; primary care; specialty care; prescription drugs; and other medical costs, including wellness services), including prescription drug spending by enrollees versus employers and issuers;
The 50 most frequently dispensed brand prescription drugs;
The 50 costliest prescription drugs by total annual spending;
The 50 prescription drugs with the greatest increase in plan or coverage expenditures from the previous year;
Prescription drug rebates, fees, and other remuneration paid by drug manufacturers to the plan or issuer in each therapeutic class of drugs, as well as for each of the 25 drugs that yielded the highest amount of rebates; and
The impact of prescription drug rebates, fees, and other remuneration on premiums and out-of-pocket costs.
The IFC provides that plan sponsors, issuers, and FEHB carriers generally will be required to submit this information aggregated at the state/market level, rather than separately for each plan. To ensure that the Departments and OPM are able to conduct meaningful data analysis and identify prescription drug trends, the IFC further provides uniform standards and definitions, including for identifying prescription drugs regardless of the dosage strength, package size, or mode of delivery.
CMS fact sheet: https://www.cms.gov/newsroom/fact-sheets/prescription-drug-and-health-care-spending-interim-final-rule-request-comments
CMS news release: https://www.cms.gov/newsroom/press-releases/biden-harris-administration-improves-transparency-and-oversight-prescription-drug-and-medical-costs
DOL EBSA news release: https://www.dol.gov/newsroom/releases/ebsa/ebsa20211117
HHS/EBSA/OPM/IRS FR notice of IFC (11/23): https://www.federalregister.gov/documents/2021/11/23/2021-25183/prescription-drug-and-health-care-spending
IRS NPRM (11/23): https://www.federalregister.gov/documents/2021/11/23/2021-25202/prescription-drug-and-health-care-spending
Elsewhere in this issue of the Federal Register , the IRS is issuing temporary regulations that increase transparency by requiring group health plans and health insurance issuers in the group and individual markets to report information about prescription drugs and health care spending to the Department of Health and Human Services (HHS), the Department of Labor (DOL), and the Department of the Treasury (the Departments). The IRS is issuing the temporary regulations at the same time that the Office of Personnel Management (OPM), the Employee Benefits Security Administration of DOL, and the Office of Consumer Information and Insurance Oversight of HHS are issuing substantially similar interim final rules with a request for comments. The text of those temporary regulations also serves as the text of these proposed regulations.