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Mar 27 -- The Centers for Medicare & Medicaid Services (CMS), Health and Human Services (HHS) invites comments by May 26, 2023 regarding the extension of the Prescription Drug and Health Care Spending data collection.

On December 27, 2020, the Consolidated Appropriations Act, 2021 (CAA) was signed into law. Section 204 of Title II of Division BB of the CAA added parallel provisions at section 9825 of the Internal Revenue Code (the Code), section 725 of the Employee Retirement Income Security Act (ERISA), and section 2799A-10 of the Public Health Service Act (PHS Act) that require group health plans and health insurance issuers offering group or individual health insurance coverage to annually report to the Department of the Treasury, the Department of Labor (DOL), and the Department of Health and Human Services (HHS) (collectively, “the Departments”) certain information about prescription drug and health care spending, premiums, and enrollment under the plan or coverage. This information will support the development of public reports that will be published by the Departments on prescription drug reimbursements for plans and coverage, prescription drug pricing trends, and the role of prescription drug costs in contributing to premium increases or decreases under the plans or coverage.  
 
The 2021 interim final rules, “Prescription Drug and Health Care Spending” (2021 interim final rules), issued by the Departments and the Office of Personnel Management (OPM) implement the provisions of section 9825 of the Code, section 725 of ERISA, and section 2799A-10 of the PHS Act, as enacted by section 204 of Title II of Division BB of the CAA. OPM joined the Departments in issuing the 2021 interim final rules, requiring Federal Employees Health Benefits (FEHB) carriers to report information about prescription drug and health care spending, premiums, and plan enrollment in the same manner as a group health plan or health insurance issuer offering group or individual health insurance coverage.
 
Section 9825 of the Code, section 725 of ERISA, and section 2799A-10 of the PHS Act require group health plans and health insurance issuers to submit certain information to the Departments about their plan or coverage, including 50 most frequently dispensed brand prescription drugs, the 50 most costly prescription drugs by total annual spending, and the 50 prescription drugs with the greatest increase in plan or coverage expenditures from the preceding plan year.

Section 9825 of the Code, section 725 of ERISA, and section 2799A-10 of the PHS Act also require plans and issuers to report total spending on health care services by the plan or coverage broken down by the type of costs (including hospital costs; health care provider and clinical service costs, for primary care and specialty care separately; costs for prescription drugs; and other medical costs, including costs for wellness services); spending on prescription drugs by the plan or coverage as well as by participants, beneficiaries, and enrollees, as applicable; and the average monthly premiums paid by participants, beneficiaries, and enrollees and paid by employers on behalf of participants, beneficiaries, and enrollees, as applicable.

Plans and issuers must report rebates, fees, and any other remuneration paid by drug manufacturers to the plan or coverage or its administrators or service providers, including the amount paid with respect to each therapeutic class of drugs and for each of the 25 drugs that yielded the highest amount of rebates and other remuneration under the plan or coverage.

Section 9825 of the Code, section 725 of ERISA, and section 2799A-10 of the PHS Act further require plans and issuers to report any reduction in premiums and out-of-pocket costs associated with prescription drug rebates, fees, or other remuneration. Under section 9825 of the Code, section 725 of ERISA, and section 2799A-10 of the PHS Act, plans and issuers must report data by June 1 of each year. Pursuant to 5 U.S.C. 8910 and OPM instruction found in FEHB Carrier Letter 2022-12, FEHB carriers must also report data by June 1 of each year.

Section 9825 of the Code, section 725 of ERISA, and section 2799A-10 of the PHS Act additionally require the Departments to publish on the internet a report (Section 204 public report) on prescription drug reimbursements for plans and coverage, prescription drug pricing trends, and the role of prescription drug costs in contributing to premium increases or decreases under the plans or coverage, with information that is aggregated so that no drug or plan specific information is made public. This Section 204 public report must be published no later than 18 months after the date on which plans and issuers are required to first submit the information and biannually thereafter.

Prescription Drug Data Collection (RxDC): https://www.cms.gov/cciio/programs-and-initiatives/other-insurance-protections/prescription-drug-data-collection
Draft data submission guide and supporting statement: https://www.cms.gov/https/wwwcmsgov/regulations-and-guidance/legislation/paperworkreductionactof1995/pra-listing/cms-10788
FRN: https://www.federalregister.gov/d/2023-06226

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