On June 29, 2010, CMS notified Congress that this obligation had been satisfied.
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. 3305. IMPROVED INFORMATION FOR SUBSIDY ELIGIBLE INDIVIDUALS REASSIGNED TO PRESCRIPTION DRUG PLANS AND MA–PD PLANS. Section 1860D–14 of the Social Security Act (42 U.S.C. 1395w– 114) is amended— (1) by redesignating subsection (d) as subsection (e); and (2) by inserting after subsection (c) the following new subsection: ‘‘(d) FACILITATION OF REASSIGNMENTS.—Beginning not later than January 1, 2011, the Secretary shall, in the case of a subsidy eligible individual who is enrolled in one prescription drug plan and is subsequently reassigned by the Secretary to a new prescription drug plan, provide the individual, within 30 days of such reassignment, with— ‘‘(1) information on formulary differences between the individual’s former plan and the plan to which the individual is reassigned with respect to the individual’s drug regimens; and ‘‘(2) a description of the individual’s right to request a coverage determination, exception, or reconsideration under section 1860D–4(g), bring an appeal under section 1860D–4(h), or resolve a grievance under section 1860D–4(f).’’.