Who says Congress can’t agree on anything? On February 5, the entire roster of the Senate Finance Committee sent Centers for Medicare and Medicaid Services (CMS) Administrator Marilynn Tavenner a letter opposing a proposed rule that would reduce the number of “protected classes” under the Medicare prescription drug benefit (otherwise known as Part D). When a bipartisan group of two dozen Senators who have jurisdiction over your programs opposes something, it’s probably indicative of a major issue.
Part D was created in 2003 to ensure that patients have sufficient access to prescription drugs. For certain drugs – antidepressant, antipsychotic, anticonvulsant, immunosuppressant, antiretroviral, and antineoplastic drugs – current Part D plans may not impose utilization management tools such as step therapy or prior authorization requirements. The history leading up to this latest proposed rule from CMS removing some of these drugs from protected status is arduous. To implement the 2008 Medicare Improvements for Patients and Provides Act (MIPPA), CMS published an interim final rule in 2009 that examined the six classes listed above to see if modifications were warranted and whether an “exceptions” process to the protected class rule was necessary. For the following year (2010), the protected classes would remain intact and unchanged. Before this rule was finalized, Congress passed the Affordable Care Act (ACA) which codified into law the six protected classes of concern. The ACA also instructed CMS to establish criteria for identifying classes that should be protected. CMS chose not to finalize the 2009 rule because of the ACA language and, instead, published a new rule in January 2014.
The January 2014 proposed Part D rule substantially changed the way CMS thinks about protected classes. The proposed rule defined criteria to be considered a drug class of clinical concern. To be eligible, a typical beneficiary must administer the drug within 7 days to avoid hospitalizations, incapacity, disability, or death. And, other CMS formulary requirements are not sufficient to ensure patients’ access to an appropriate range of therapies. Based on these criteria, CMS concluded that antidepressants and immunosuppressants are no longer considered protected classes and will no longer by protected classes by 2015. Additionally, by 2016, antipsychotic drugs will also no longer be protected.
The reaction to this proposed rule has been dramatic: Patients, physicians, industry, lawmakers and other stakeholders have united together to oppose the change to the protected classes, questioning as well whether this would result in the cost savings CMS anticipates.
Perhaps the greatest benefit of the rule is that for the first time in what feels like decades, there appears to be consensus in Washington. Not only is the advocacy community aligned, but so is Congress. In addition to the Senate Finance Committee letter mentioned above, the House committees also plan to send bipartisan letters, and the House Energy & Commerce Committee recently held a hearing on this issue. It seems so rare to hear advocates and policy makers on both sides of the aisle come together on a common position. When it does happen, it makes you wonder if you’re dreaming.
Comments on the rule are due March 7, and it’s anticipated that hundreds of organizations will submit letters opposing the change to the protected classes. These advocates are hard at work educating policymakers and generating momentum among their partners to stop this rule from being finalized. It’s hard to imagine that CMS will ignore this level of consensus and finalize the rule. And even if the agency does, Congressional Committee leadership has indicated they will quickly introduce and pass legislation to undo this change. Finally, a breath of fresh air and a break from partisan politics. Let’s hope this is the first of many instances this year.