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.

​On December 8, 2003, the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) was signed into law by former President George W. Bush. Prior to the enactment of the MMA, Medicare prescription drug coverage was very limited, and was generally only available for physician-administered drugs, drugs necessary for the effective use of durable medical equipment such as inhalers, and a handful of drugs listed specifically in the statute. When Congress established the Medicare Part D prescription drug benefit, it recognized that certain drug classes were vital to the beneficiaries whose lives, in many cases, depended on those drugs, and that their prescribers needed access to the full range of treatment options. For example, Congress expressed significant concern regarding the needs of Medicare beneficiaries with mental illness, as illustrated in the Conference Report that accompanied the MMA. The MMA corrected a major gap in Medicare coverage, adding a new Part D to the program and provided coverage for FDA-approved drugs that had not previously been covered. Click "PLAW 108 Published 173' to view the law.