On Monday, CMS issued a notice that, in effect, gives drug manufacturers a three-year reprieve to updating their systems to include sales in US territories in the AMP and Best Price. The government’s release about the changes that were published to Medicaid.gov can be found here.
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 Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands) beginning April 1, 2017. However, based on discussions with the U.S. territories, it has become evident that interested U.S. territories could not be ready to implement the program by this date.
Therefore, today, CMS issued an Interim Final Rule with comment period that delays the inclusion of the U.S. territories (American Samoa, 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, 2017 until April 1, 2020 which is effective on November 15, 2016. There is a 60-day comment period that will end on January 17, 2017.