Abstract

CMS hopes to require Medicare Part D plans to expand the pool of patients eligible for Part D medication therapy management (MTM), according to the new proposed rule published Friday in the Federal Register. The proposed new criteria for Part D MTM eligibility would include patients having two or more chronic conditions, with at least one being a core chronic disease; taking any two or more covered Part D drugs; and having a minimum annual drug spend of $620. “CMS clearly indicated that they believe MTM is a quality service, that pharmacists’ services are very beneficial and cost effective, and that they fully intend for MTM utilization to expand significantly. It’s possible that something like 50% of Medicare beneficiaries will now be eligible for MTM, and it may well be more than that,” said Jillanne Schulte, JD, APhA Director of Regulatory Affairs. The agency’s loosening of the eligibility criteria for Part D MTM is a “great opportunity for pharmacists to show what they can do.” “One of the really great things about [the proposed rule] is it’s a floor. So if a plan wants to go above and beyond what’s in the rule, it can,” Schulte added. “It can extend MTM to any number of people, in theory.” APhA’s detailed analysis of CMS’s proposed rule on “Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs” is under way. The Association plans to comment by the deadline of March 7, 2014. “A lot of the rule is applicable more to Part D sponsors,” in terms of both fraud and abuse, and general organizational and contracting requirements, explained Schulte. But “a lot of these big changes are going to trickle down to pharmacists.” CMS also proposed changes related to the six protected drug categories or classes of clinical concern. When Part D started, CMS implemented a policy that all Part D plans must include on their formularies “all or substantially all” Part D drugs in six drug classes: antineoplastics, anticonvulsants, anti- retrovirals, antipsychotics, antidepres- sants, and immunosuppressants; the Affordable Care Act later made this policy the law, but allowed CMS to specify criteria for identifying protected classes through rulemaking, according to the agency’s January 6 fact sheet on the proposed rule. MORE ONLINE■An expanded version of this article is available at www.pharmacist.com/under-cms-proposed-rule-mtm-coverage-would-expand-greatly.■The CEO Blog perspective is available at www.pharmacist.com/CEOBlog/cms-proposes-rule-expanding-access-part-d-mtm. ■An expanded version of this article is available at www.pharmacist.com/under-cms-proposed-rule-mtm-coverage-would-expand-greatly.■The CEO Blog perspective is available at www.pharmacist.com/CEOBlog/cms-proposes-rule-expanding-access-part-d-mtm. Under two criteria proposed by CMS, the antineoplastic, anticonvulsant, and antiretroviral drug classes would remain protected classes of drugs, but as of 2015, Part D formularies would no longer be required to include all anti- depressants and immunosuppressants. “Antipsychotics will remain protected at least through 2015 while CMS evaluates additional considerations and the need for any other formulary exceptions,” according to the CMS fact sheet. CMS has “basically said that this is a cost issue,” said Schulte. The proposed rule also contains two big changes related to mail service that may result in more Part D beneficiaries walking into their local pharmacy. First, CMS would require mail-service pharmacies to fill prescriptions within 3 or 5 days and would not permit mail-service pharmacies to waive cost sharing for a Part D plan unless cost sharing is waived for all plan enrollees. “I don’t think the response from most Part D plans is going to be to waive more copayments. I think they’re going to cut the co- payment waivers off,” Schulte said. Second, CMS stated that new prescriptions and 30-day prescriptions should not be available through mail service. “If Part D plans comply, it’s going to be better for patients because when they do get a new prescription, they will have to see their pharmacist,” Schulte said. In addition to more patient counseling options, pharmacies may also see more foot traffic in stores.

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