The Consolidated Appropriations Act (CAA), passed by Congress in 2021, requires insurance companies (issuers) and employer-sponsored health plans to annually submit certain 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 (collectively, the Departments).
What is the Purpose of the Reporting?
Presidential Executive Order 14036 (EO 14036) directed the federal government to “enforce the antitrust laws to combat the excessive concentration of industry, the abuses of market power, and the harmful effects of monopoly and monopsony.” The prescription drug cost data collection (RxDC) will provide information about competition and market concentration in the pharmaceutical and health care industries and assist policymakers in supporting of the goals of EO 14036, including identifying excessive pricing of prescription drugs, promoting the use of lower-cost generic drugs, and addressing the impact of pharmaceutical manufacturer rebates, fees, and other remuneration on prescription drug prices.
Reporting for 2020 and 2021 cost data is due by December 27th, 2022. Thereafter, annual reporting will be due for each calendar year by June 1st of the following year. 2022 cost data will need to be submitted by June 1st, 2023.
Reporting for employer-sponsored plans consists of 1 plan file, 8 separate data files, and accompanying narratives that need to be submitted electronically to a Centers for Medicare and Medicaid Service (CMS) website called HIOS. The required plan file and data files are as follows:
- P2. Group health plan list
- D1. Premium and Life-Years
- D2. Medical 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
Who Is Responsible to Submit Data to CMS?
Employers who sponsor only fully-insured health plans will generally be able to rely on their carrier to submit the required reporting.
However, employers who sponsor self-funded (or level-funded) plans may have to submit some of the data themselves. This will depend on their particular plan administrative arrangements, and the approach their vendors are taking to the reporting requirements. For example, a number of large self-funded plan vendors (UHC, Blue Cross of IL, and others) have taken the position that the vendor will submit all files except the D1 file, which the employer must file on their own. The D1 file includes data such as employer/employee contributions, membership data, ASO fees, and stop-loss costs.
Any organization submitting data to CMS is referred to as a “reporting entity.” There may be multiple
reporting entities involved in compiling and submitting data for any particular employer plan. The required files and narratives do not all have to be submitted simultaneously. It is acceptable for different reporting entities to submit files separately. However, anytime a reporting entity submits any data files , a plan list file (P2 – Group health plan list) must accompany the data file(s).
Where Does a Reporting Entity Submit the Data?
All files must be uploaded through the CMS HIOS system. If an employer is required to submit any data themselves, they must first set up their organization with a HIOS account.
CMS has set up a RxDC website that contains reporting instructions, templates for the data files and more at https://www.cms.gov/CCIIO/Programs-and-Initiatives/Other-Insurance-Protections/Prescription-Drug-Data-Collection.
To assist with establishing a HIOS account, CMS has issued a HIOS user manual and a HIOS Quick Reference Guide. The user manual, guide and other reporting instructions and templates can also be found on the CMS RxDC website.
CMS also set up a help desk to assist with this process, which can be reached at 1-855-267-1515 or CMS_FEPS@cms.hhs.gov.
What do Employers Need to Do Now?
In most instances, your Carrier, Third Party Administrator (TPA) or Pharmacy Benefit Manager (PBM) will be submitting some, if not all, the required reporting. If you have not been notified by your vendor(s), please contact your Horton Service Team.
Material posted on this website is for informational purposes only and does not constitute a legal opinion or medical advice. Contact your legal representative or medical professional for information specific to your legal or medical needs.