GHP:

Prescription Drug Data Collection and Reporting

The Consolidated Appropriations Act, 2021 (CAA), Title II, Division BB, includes an annual reporting requirement for group health plans and health insurers to submit data regarding drug costs to the Department of Treasury, Department of Labor (DOL), and Department of Health and Human Services (HHS).

Background

The CAA, 2021, included the No Surprises Act, which was intended to increase transparency in healthcare costs (reduce “surprise” bills from services or out-of-network providers). Included in the act are annual reporting requirements related to prescription drug and healthcare spending data, referred to as RxDC requirements. The first reporting was due January 31, 2023, for 2020 and 2021 calendar years. Subsequent reporting is due annually on June 1. Good faith efforts or extensions do not apply beginning with the 2024 report.

Note: The law refers to the “plan year” for RxDC reporting. However, the law also changed the definition in the final rules to the same meaning as “reference year,” which means calendar year.

Plan Types

The reporting requirements apply to most employer-sponsored health plans and all health insurance carriers. The following plans are required to report to HHS:

• Fully insured group health plans
• Self-funded group health plans
• Non-federal government health plans
• Church plans subject to Internal Revenue Code regulations
• Federal Employee Health Benefits (FEHB) plans

The following plans are not required to report to HHS:

• Account-based plans such as health reimbursement arrangements (HRAs), health savings accounts (HSAs), and health flexible spending accounts (HFSAs)
• Plans that are excepted benefit plans such as short-term plans, fixed indemnity plans, and specific disease plans
• Medicare Advantage and Part D prescription drug plans
• Children’s Health Insurance Program (CHIP) plans
• Medicaid Basic Health Program (BHP) plans

Fully insured group health plans should confirm the carrier is completing the reporting. Self-funded group health plans may contract with their third-party administrator (TPA), pharmacy benefits manager (PBM), or other reporting entity to complete the annual reporting to HHS. The TPA or PBM will generally require the plan to provide some plan- specific information to assist with the reporting. The Centers for Medicare & Medicaid Services (CMS) does not currently notify plans when a reporting entity submits data. Plans must reach out to the reporting entity to confirm the submission has been completed.

Required Files

Applicable plans must submit one or more plan lists (P1–P3), eight data files (D1–D8), and a narrative response. Employer-sponsored group health plans will use plan list P2. Plan list P1 is used for individual plans, and plan list P3 is used for FEHB plans. The eight data files are to report premium and spending on an aggregated level as follows:

• D1 Premium and Life-Years
• D2 Spending by Category
• D3 Top 50 Most Frequent Brand Drugs
• D4 Top 50 Most Costly Drugs
• D5 Top 50 Drugs by Spending Increase
• D6 Rx Totals
• D7 Rx Rebates by Therapeutic Class
• D8 Rx Rebates for the Top 25 Drugs

Note: Data files D1 and D3–D8 cannot be aggregated at a higher level than used in file D2. All current and past submissions requiring a D6 file must use the January 15, 2025, template.

The narrative response should be in a text or PDF format and describe the following:

• Employer size for self-funded plans
• Net payments from federal or state reinsurance or cost-sharing reduction programs
• Drugs missing from the CMS crosswalk
• Medical benefit drugs
• Prescription drug rebate descriptions
• Allocation methods for prescription drug rebates
• The impact of prescription drug rebates

Submission

The data report is submitted through the Health Insurance Oversight System (HIOS) under the RxDC module located on the CMS Enterprise Portal. Submissions are due each year by June 1 for the prior calendar year. For example, 2024 calendar year data are due on June 1, 2025. Multiple entities, or vendors, may need to submit different data for the same employer-sponsored plan. For example, a self-funded group health plan may submit the D1 file, use its TPA to submit the D2 file, and use its PBM to submit the D4 file. A reporting submission is considered complete if all required files are submitted, regardless of how many reporting entities are involved. The RxDC reporting instructions and FAQs Part 56 contain detailed information and examples. Employers that are not submitting their own data do not need to create a CMS Enterprise Portal or HIOS account. Additional FAQs and instructional materials are available from CMS. Employers may get help with HIOS questions, password resets, account issues, and error messages from the CMS Marketplace Service Desk by email at CMS_FEPS@cms.hhs.gov and by phone at 855-267-1515.

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