The deadline for responding to the RFI is July 23, 2021 at 5 pm (ET). At this point, the effective date for the first set of reporting remains December 27, 2021. For subsequent years, the deadline is June 1.

The reporting requirement

Group health plans are required to report the following information to the secretaries of the DOL and HHS about their prescription drug benefits for the previous plan year:

• The plan year dates
• The number of participants and beneficiaries
• Each state in which the plan coverage is offered
• The 50 brand prescription drugs most frequently dispensed by pharmacies for claims paid by the plan and the total number of paid claims for each drug
• The 50 most costly prescription drugs with respect to the plan by total annual spending and the annual amounts spent for each drug
• The 50 prescription drugs with the greatest increase in plan expenditures over the plan year and for each, the change in amounts expended by the plan in each plan year
• Total spending on health care services by the plan broken down by: type of costs (hospital, provider, Rx, other) and spending on prescription drugs broken down by health plan spending and enrollee spending
• Average monthly premium paid by employers and participants
• Any impact on premiums by rebates, fees and other remuneration paid by drug manufacturers, including the amounts for each therapeutic class and the amounts paid for each of the 25 drugs that yielded the highest amount of rebates or other remuneration
• Any reduction in premiums and out-of-pocket costs associated with rebates, fees or other remuneration.

Departments will publish information

Using the information reported by plans, the Departments will analyze trends in overall spending and publish analyses intended to enable plans to negotiate fairer rates and lower prescription drug costs. 

The Departments will post the first report no later than 18 months after is required. Thereafter, they will post the report every two years.

The RFI questions

Questions in the RFI, which was published in the June 23, 2021 Federal Register, fall into several categories:

• General implementation concerns
• Definitions
• Entities that must report
• Information required to be reported
• Coordination with other reporting requirements
• Public report and privacy protections
• Regulatory impact analysis

Key issues of interest to plan sponsors, who may wish to comment on the RFI, include questions concerning implementation challenges and operational concerns, such as reporting methods. In addition, the Departments ask what data is readily available to plan sponsors, and whether there are unique considerations for different types of plans (e.g., self-insured plans, multiemployer plans and plans that use a third-party administrator). The Departments also ask whether there are methods of aggregating data reports that they should consider.

Action item for plan sponsors

The RFI is an opportunity to weigh in on the new prescription drug reporting requirements. Plan sponsors subject to the requirements should review these issues with their professional advisors to determine what challenges appear for reporting and how best to resolve them.

For additional information about the Consolidated Appropriations Act requirements, see Segal’s compliance plan.