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.
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