As of January 2013, CMS had not implemented guidance pursuant to this provision.
Note that the final FY 2014 Medicare Advantage (MA) rate notice, which was released on April 1, 2013, references this provision. Specifically, the MA notice indicates that, “despite the removal of the restrictions on barbiturates coverage, we do not believe that there are many more barbiturates that currently would meet the definition of a Part D drug. A preliminary review has identified only a few potential additional products likely to qualify as Part D drugs in 2014, the most notable being FDA-approved butalbital-containing products used for the treatment of headaches.”
On September 12, 2013, CMS issued Medicaid Drug Rebate Program Notice #88 to participating drug manufacturers regarding the change at section 2502 that requires, effective January 1, 2014, the removal of “barbiturates, benzodiazepines, and agents used to promote smoking cessation from the list of drugs a state Medicaid program may exclude from coverage or otherwise restrict.” The notice also indicates that “drugs used to promote smoking cessation including OTC drugs, are no longer excluded from coverage or otherwise restricted under the Medicaid program.” In addition, the notice discusses the implications relative to dual-eligible beneficiaries.
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 March 27, 2014, the CDC issued a report (press release) documenting “uneven progress in expanding state Medicaid coverage for smoking cessation,” and noting that “more smokers would quit if state Medicaid programs covered more cessation treatments and removed barriers to coverage.”
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. 2502. ELIMINATION OF EXCLUSION OF COVERAGE OF CERTAIN DRUGS. (a) IN GENERAL.—Section 1927(d) of the Social Security Act (42 U.S.C. 1397r–8(d)) is amended—(1) in paragraph (2)— (A) by striking subparagraphs (E), (I), and (J), respectively; and (B) by redesignating subparagraphs (F), (G), (H), and (K) as subparagraphs (E), (F), (G), and (H), respectively; and (2) by adding at the end the following new paragraph: ‘‘(7) NON-EXCLUDABLE DRUGS.—The following drugs or classes of drugs, or their medical uses, shall not be excluded from coverage: ‘‘(A) Agents when used to promote smoking cessation, including agents approved by the Food and Drug Administration under the over-the-counter monograph process for purposes of promoting, and when used to promote, tobacco cessation. ‘‘(B) Barbiturates. ‘‘(C) Benzodiazepines.’’. (b) EFFECTIVE DATE.—The amendments made by this section shall apply to services furnished on or after January 1, 2014.