CMS Releases the Final Rule of Covered Outpatient Drug

CMS published a notice on the day of Monday that, in effect, provides drug manufacturers a 3-year reprieve to updating their systems to involve sales in United States territories in the AMP and Best Price. The release of government about the modifications that were released to Medicaid.gov can be discovered here.

The Covered Outpatient Drug Final Rule with Comment Period (CMS-2345-FC) was released by the CMS (Center for Medicare & Medicaid Services) in the Federal Register (81 FR 5170) on the day of February 1, 2016. They amended and modified the regulatory definitions of “States” and “United States” to involve the U.S. territories (American Samoa, Guam, the Northern Mariana Islands, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands) starting on the day of April 1, 2017 as part of that final rule with comment.. Although, based on negotiations with the United States territories, it has become obvious that interested U.S. territories couldn’t be ready to enforce and implement the program by this date.

CMS today, hence, published an Interim Final Rule with comment period that delays the inclusion of the U.S. territories (The Northern Mariana Islands, American Samoa, Guam, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands) in the definitions of “States” and “United States” from the day of April 1, 2017 until April 1, 2020 which is effective on the day of November 15, 2016. There is a sixty-day comment period that will end on the day of January 17, 2017.

For further and in-depth information, please visit the Covered Outpatient Drugs Policy page on Medicaid.gov.