CMS is redefining how it determines which drug classes qualify for protected status under Medicare Part D and, as a result, plans to remove two of the current six protected classes – antidepressants and immunosuppressants – from the list.

The changes are contained in a proposed rule addressing Medicare Part D and Medicare Advantage plans, released Jan. 6 and scheduled for Jan. 10 publication in the Federal Register.

Since the start of the Part D prescription drug benefit, CMS has had six drug categories and classes of “clinical concern,” commonly known as protected classes: antineoplastics, anticonvulsants, antiretrovirals, antipsychotics, antidepressants and immunosuppressants to prevent organ transplant rejection. These were originally established through CMS sub-regulatory guidance for Part D plan formularies. In 2008, Congress directed the agency to develop and make public criteria for identifying protected classes and the agency worked on a regulation. The Affordable Care Act later said the agency should not alter the list of protected classes until a rule is issued and CMS said it wanted to review the ACA’s various Medicare provisions before doing so Also see "Medicare Part D Protected Classes Retained For 2011, With Exceptions Process, In Final CMS Rule" - Pink Sheet, 7 April, 2010..

Drug plans must cover “all or substantially all” products in a protected class, thus plans could limit the antidepressant or immunosuppressant products they cover if the agency’s new proposal becomes final. Conversely, the proposed rule could provide an opportunity for new classes to be added to the protected list.

In the proposed rule, CMS outlines two criteria that the agency will use to define protected classes. A class must meet both criteria to become protected.

The first criterion is if “in the case of a typical beneficiary who has a disease or condition treated by drugs in the following category or class, hospitalization, persistent or significant incapacity or disability, or death likely will result if initial administration (including self-administration) of a drug in the category or class does not occur within seven days of the date the prescription for the drug was presented to the pharmacy to be filled.”

The second criterion is “if CMS cannot establish that a formulary that includes fewer than all Part D drugs from within that category or class would include sufficient drugs needed to treat the diseases or conditions generally treated by such drugs. In other words, CMS cannot reasonably establish more specific CMS formulary requirements because there are too many potential drug-and-disease-specific scenarios that require specific drugs from within a category or class, even within sub-classes. This would be the case when the different drugs within a category or class are uniquely associated with specific clinical applications because of the unique effects of such drugs or the variable nature of the disease or condition treated by such drugs.”

The rule says CMS convened a panel of CMS pharmacists and the Chief Medical Officer for the Center for Medicare to identify which classes met the proposed criteria.

The panel concluded that of the six current protected classes, anticonvulsants, antineoplastics, and antiretrovirals meet both criteria, while antidepressants, antipsychotics, immunosuppressants do not. It also found that “while other [additional] drug categories and classes met one of the criteria, no other drug categories or classes met both criteria.”

However, while it is proposing to drop antipsychotics and immunosuppressants from protected status, CMS plans to keep antipsychotics protected through 2015 while it continues to gather more information on the class.

“We wish to make certain we have not overlooked a need for any transitional considerations,” the rule says. “This is because the risks associated with untreated psychotic illness, as differentiated from the broad category of mental illness, have the potential to be so severe.”

CMS Proposes Part D Protected Drug Criteria, Drops Antidepressants And Immunosuppressants

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