Covered Outpatient Drug; Further Delay of Inclusion of Territories in Definitions of State and United States (CMS-2345-IFC3)

The Centers for Medicare & Medicaid Services (CMS) published the Covered Outpatient Drug Final Rule with Comment Period (CMS-2345-FC) in the Federal Register (81 FR 5170) on February 1, 2016. As part of that final rule with comment, we amended the regulatory definitions of “States” and “United States” to include the U.S. territories (American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands) beginning April 1, 2017. Inclusion of the territories in the definition of United States would allow them to participate in the Medicaid Drug Rebate Program (MDRP). Subsequently, we published an interim final rule in the November 15, 2016 Federal Register, that amended the regulatory definitions of “States” and “United States” to include the U.S. territories beginning April 1, 2020 rather than April 1, 2017 (interim final rule).

However, based on further discussions with the U.S. territories since the publication of the first interim final rule, we have learned that while the territories are making progress, only one territory would be prepared to implement the MDRP program by April 1, 2020.

Therefore, today, CMS issued another Interim Final Rule with comment period that further delays the inclusion of the U.S. territories (American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands) in the definitions of “States” and “United States” from April 1, 2020 until April 1, 2022. There is a 60-day comment period for this interim final rule that will end on January 24, 2020.

• Interim Final Rule: Covered Outpatient Drug; Further Delay of Inclusion of Territories in Definitions of State and United States (CMS-2345-IFC3)
• More information on Covered Outpatient Drugs Policy