Notably, CMS proposes to significantly revise the agency’s policy related to the protected classes. Since the start of the Part D benefit, CMS has required Part D plans to cover “substantially all” drugs within six drug classes: immunosuppressants, antineoplastics, anticonvulsants, antidepressants, antipsychotics and antiretrovirals. The agency implemented the policy to ensure that patients had access to the full range of treatments in these “classes of clinical concern.” In the rule, CMS proposes to eliminate the requirements for plans to cover all products in the antidepressants and immunosuppressants classes for CY 2015. CMS also is considering removing the requirement for the antipsychotic class for CY 2016.

The proposed rule’s impact across different healthcare sectors:

CMS is accepting comments through March 7, 2014.

Life Sciences: The changes to the protected classes could significantly diminish formulary access for products in the antidepressants and immunosuppressant classes beginning in 2015, and will create heightened competition in the classes for favorable placement. Manufacturers of antipsychotics will need to build a case to maintain some of the patient protections for these products as CMS considers its 2016 policy for this class. Expansions to the Medication Therapy Management Programs MTMP could increase medication adherence for high risk patients, though explicit requirements for service offerings are limited.
Health Plans: Proposed revisions to the meaningful differences policy will restrict the market’s top sponsors from offering more than two plan options in a given Part D region, leading to significant consolidation in CY 2016 among the top sponsors. Additionally, the proposed rule will limit the ability of several sponsors to offer low-cost enhanced PDPs that attract cost-conscious enrollees. However, the proposed protected classes policy change will allow Part D plans greater management over which products from the antidepressants and immunosuppressant classes are included on formulary and may reduce costs through improved negotiating power with manufacturers of these drugs.
Pharmacies: The proposed rule could have significant impacts on plans’ preferred pharmacy arrangements. First, requiring plans to include “any willing pharmacy” in their preferred pharmacy network will open up preferred networks to a larger number of pharmacies, unless a smaller network is able to offer deeper discounts that other pharmacies are unwilling or unable to match. Secondly, explicitly requiring prices at preferred pharmacies to consistently fall below prices at non-preferred pharmacies may require some sponsors and their preferred pharmacies to reduce prices, particularly for mail-order claims, which CMS found to be a significant source of excess costs in some preferred networks.

Read CMS’ proposed rule here.