On a related note, in a September 20, 2013 informational bulletin reiterating the annual process by which certain Low Income Subsidy (LIS) eligible individuals are reassigned, CMS indicated that it intends to mail a second blue “Affordable Care Act Formulary Notice” (in addition to the “Choosers Notice”) in December 2013 to all LIS beneficiaries who will be reassigned to a new PDP.
On January 6, 2014, CMS issued a proposed rule delineating Contract Year 2015 MA and Part D policy and technical changes. The rule proposes, among other things, to limit and redefine, based on new criteria, Part D’s protected drug classes to initially include anticonvulsants, antiretrovirals and antineoplastics — but not antidepressants and immunosuppressants – as “drug categories and classes of clinical concern” for the 2015 coverage year. The rule addresses each of these provisions of the ACA in some manner. A CMS fact sheet is available. Comments are due by March 7.
On March 10, 2014, the Administration informed top Congressional leaders that it will not finalize some of the key changes to Part D that it had proposed in a draft regulation issued January 10. The elements of the Proposed Rule that the Administration will not finalize include: (1) Changes to the Six Protected Classes, which would have excluded mental health and immunosuppressive drugs from these protections (such as a requirement that plans cover all drugs in these classes), among other revisions; (2) Reductions in the number of plans a Part D sponsor may offer; (3) Limitations on the use of preferred pharmacies; and (4) New interpretation of the non-interference provisions. The Administration notes it will gather additional input and effectively reserves the right to advance changes in these areas in future years. But no changes will be made for the CY15 plan year. It will move forward with other elements of the Rule, as discussed in the Administration’s letter to Congressional members. A copy of the letter is available externally here.
On May 19, CMS issued a final rule on MA and Part D contract year 2015 technical changes. While the final rule codifies a number of fraud and abuse-related proposals, as signaled in an earlier letter to Congress the final rule does not adopt controversial proposed modifications to Part D protected drug classes or limitations on offering more than two Part D plans in a given region. The rule addresses each of these provisions of the ACA in some manner. A fact sheet is available here.
SEC. 3307. IMPROVING FORMULARY REQUIREMENTS FOR PRESCRIPTION DRUG PLANS AND MA–PD PLANS WITH RESPECT TO CERTAIN CATEGORIES OR CLASSES OF DRUGS. (a) IMPROVING FORMULARY REQUIREMENTS.—Section 1860D– 4(b)(3)(G) of the Social Security Act is amended to read as follows: ‘‘(G) REQUIRED INCLUSION OF DRUGS IN CERTAIN CAT- EGORIES AND CLASSES.— ‘‘(i) FORMULARY REQUIREMENTS.— ‘‘(I) IN GENERAL.—Subject to subclause (II), a PDP sponsor offering a prescription drug plan shall be required to include all covered part D drugs in the categories and classes identified by the Secretary under clause (ii)(I). ‘‘(II) EXCEPTIONS.—The Secretary may establish exceptions that permit a PDP sponsor offering a prescription drug plan to exclude from its formulary a particular covered part D drug in a category or class that is otherwise required to be included in the formulary under subclause (I) (or to otherwise limit access to such a drug, including through prior authorization or utilization management). ‘‘(ii) IDENTIFICATION OF DRUGS IN CERTAIN CATEGORIES AND CLASSES.— ‘‘(I) IN GENERAL.—Subject to clause (iv), the Secretary shall identify, as appropriate, categories and classes of drugs for which the Secretary determines are of clinical concern. ‘‘(II) CRITERIA.—The Secretary shall use criteria established by the Secretary in making any determination under subclause (I). ‘‘(iii) IMPLEMENTATION.—The Secretary shall establish the criteria under clause (ii)(II) and any exceptions under clause (i)(II) through the promulgation of a regulation which includes a public notice and comment period. ‘‘(iv) REQUIREMENT FOR CERTAIN CATEGORIES AND CLASSES UNTIL CRITERIA ESTABLISHED.—Until such time as the Secretary establishes the criteria under clause (ii)(II) the following categories and classes of drugs shall be identified under clause (ii)(I): ‘‘(I) Anticonvulsants. ‘‘(II) Antidepressants. ‘‘(III) Antineoplastics. ‘‘(IV) Antipsychotics. ‘‘(V) Antiretrovirals. ‘‘(VI) Immunosuppressants for the treatment of transplant rejection.’’. (b) EFFECTIVE DATE.—The amendments made by this section shall apply to plan year 2011 and subsequent plan years.