The Centers for Medicare & Medicaid Services on Wednesday gave drugmakers six more months to comply with the Trump-era regulation requiring them to calculate the “best price” for drugs under Medicaid’s drug rebate program using discounts they offer patients.
The new final rule will officially delay best prices reporting from Jan. 1, 2022, to July 1, 2022.
CMS also when U.S. territories including American Samoa, Northern Mariana Islands, Guam, Puerto Rico, and the Virgin Islands can join the Medicaid Drug Rebate Program until Jan. 1, 2023 at the earliest and April 1, 2024 at the latest.
CMS proposed these delays in May in response to complaints that more time was needed to implement the best price program while still devoting resources to the public health emergency.
In its latest ruling, the agency stated “demands on researching, producing, and distributing COVID-19 drug treatments and vaccines have likely diverted some manufacturer financial and human resources from developing and implementing system changes that would be required to enter multiple best price offers.”
After considering public comments, stakeholder needs, and various territories and manufacturers, CMS decided to extend the reporting deadline, in order to ensure that complex system changes could be made and guarantee access and quality of care for Medicaid patients.
The final inclusion date of April 1, 2024 is meant to give territories time to decide whether they want to participate in or waive out of the Medicaid program, as well as the ability to accommodate their resource needs during the pandemic.
“We are allowing the territories additional time to develop needed systems and policy changes, to avoid unintended increases in drug costs and access concerns,” CMS said in its final rule. “The needed systems must be capable of collecting, reporting, validating, and tracking drug utilization on an ongoing basis. In addition, they require extensive advance planning and budgeting.”