In 2008, under Section 176 of the Medicare Improvements for Patients and Providers Act (MIPPA), Congress strengthened the so-called protected classes policy by codifying it in the Part D statute. In a strong congressional affirmation of the ongoing importance of these protections, MIPPA required Medicare Part D drug plans to include in their formularies access to all or substantially all drugs in the six identified categories of priority. MIPPA also specified two statutory criteria that CMS had to use in identifying additional classes of clinical concern: (1) restricted access to the drugs in the class would have major or life-threatening clinical consequences for individuals with a disease or disorder treated by drugs in such class; and (2) there is a significant need for such individuals to have access to multiple drugs within a class due to unique chemical actions and pharmacological effects of the drugs within a class. Click ‘Read More’ to view the law.
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