It was recently reported that Christina Ritter, an official from the Center for Medicare and Medicaid Innovation (CMMI) will temporarily lead the implementation of the Inflation Reduction Act. The memorandum, dated June 2, 2023, was sent to drug manufacturers interested in submitting a small biotech exception request for initial price applicability year 2026 of the Medicare Drug Price Negotiation Program, and came from “Christina Ritter, Acting Director, Medicare Drug Rebate and Negotiations Group, Center for Medicare.”
The memorandum noted that the Centers for Medicare and Medicaid Services (CMS) released the Small Biotech Exception functionality in the Health Plan Management System (HPMS) for initial price applicability year 2026 of the Medicare Drug Price Negotiation Program. Under the Inflation Reduction Act, “negotiation eligible drug” excludes a qualifying single source drug that meets the requirements for the exception for small biotech drugs for initial price applicability years of 2026, 2027, and 2028.
However, to accurately identify whether a single source drug qualifies for the Small Biotech Exception for initial price applicability year 2026, CMS needed certain information. That information must have been submitted only through HPMS, not e-mail or any other format. The information also needed to be certified by one of the following: the CEO of the company, the CFO of the company, an individual (other than the CEO or CFO) who has authority equivalent to the CEO or CFO, or an individual with the directly delegated authority to perform the certification on behalf of one of those three individuals.
The deadline for submitting the Small Biotech Exception requests was July 3, 2023. Additionally, because of the tight deadlines for the first year of the Negotiation Program, CMS cannot accept any incomplete or late requests for the Small Biotech Exception for initial price applicability year 2026.
CMS will notify each manufacturer that submitted a Small Biotech Exception request whether their drug received the exception for initial price applicability year 2026 in September 2023. The notice will be sent via email to the individual who submitted the form data entry through HPMS. CMS will also publish the number of drugs that applied for – and received – the Exception for initial price applicability year 2026 when the agency publishes the selected drug list on September 1, 2023.
The agency has told Congress it intends to hire nearly 100 full-time staff to implement the legislation and has continued to slowly staff up before the first deadline of September 1, 2023, when CMS will announce the drugs selected for the drug price negotiation program.