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    CMS Releases Draft 2016 Call Letter for Medicare Part D and Medicare Advantage

     The Centers for Medicare and Medicaid Services (CMS) has released the highly anticipated draft 2016 Medicare Part D and MA call letter (attached). Given activity over the last year with CMS proposing significant changes to the program, this release was anxiously awaited. However, a brief review of the draft suggests that CMS has largely dismissed the significant changes it proposed last year. Specifically for preferred pharmacy networks (preferred cost sharing), the draft call letter makes no changes to the existing system. CMS also did not make any substantial policy changes to the medication therapy management provisions but will release a separate memorandum at a later date. A few other policy issues of note are considered below.

    Comments on the draft call letter are due on March 6, 2015. If you would like to submit comments to AMCP, please email by Friday, February 27, 2015. AMCP will host a webinar on the draft call letter provisions on Thursday March 12, 2015 from 2-3 pm EST. This webinar will be free to AMCP members. Registration information will be provided next week. CMS will release the final 2016 call letter on April 6, 2015.

    In regard to preferred pharmacy networks, a CMS study released last year found that the vast majority of beneficiaries have appropriate access to preferred pharmacy networks, but that a small number of urban beneficiaries may experience access issues. Given these findings, CMS indicated in the draft call letter that it will not make changes to pharmacy access requirements, but will monitor the outliers. (CMS’ discussion on this issue begins on page 148 of the draft call letter.) This position is consistent with AMCP’s perspective that preferred pharmacy networks promote market competition by serving as a tool to encourage affordable access to medications through negotiations between Part D plans and pharmacies.

    Other provisions of note:

    Changes to Medicare Star Ratings program begins on page 82. AMCP is reviewing this section and will release further information.

    Value-Based Contracting to Reduce Costs and Improve Outcomes (page 113)
    CMS will request data and information from Medicare Advantage (MA) organizations regarding the use of incentive payments and value-based contracting. The draft call letter does not mention the use of stand-alone Medicare Part D plans for these purposes but has requested input and information in the past.

    Utilization Review Controls in Medicare Part D and Opioid Overutilization Monitoring System (OMS) (page 142)
    CMS has found that since implementation of the OMS in 2013, inappropriate use of acetaminophen (APAP) and opioids have decreased. Table 1 on page 144 shows trends of the effect of use of soft edits in this area. Given the improvements in APAP utilization, CMS suggests that plans continue to use soft edits for overutilization except in circumstances associated with egregious cases of overutilization where hard edits are necessary. For opioids, CMS expects plans to implement through pharmacy and therapeutics committees specifications for a soft edit for morphine equivalent dose (MED) at the point of sale (POS) and account for known exceptions for high utilization of opioids, such as a cancer diagnosis or hospice care. CMS recommends that the soft edit be triggered at a 200 mg MED with 2 or more prescribers. Table 3 on page 146 provides information on the impact of these soft edits with differing levels of MEDs and numbers of prescribers. CMS seeks comments on the feasibility of its proposed approach. CMS has further indicated that before implementing the soft edits, formularies submitted to CMS must reflect the edits as described on page 146.

    CMS is also considering requiring OMS to provide sponsors with contract-level rates and contract average rate to compare use of APAP and opioids across plans. CMS is also considering the following measures based on unsafe opioid utilization: 

    • High-dose opioids in opioid naïve patients 
    • More than 90mg cumulative MED daily of short-acting opioids for greater than 90 consecutive days 
    • Concurrent buprenorphine and opioid use for more than 90 consecutive days 
    • Concurrent opioid and other CNS depressant use from multiple prescribers 

    CMS seeks comments on these suggestions. 

    CMS Considers Extension of OMS on Other Classes of Medications (page 147)
    Given the success of OMS for reducing inappropriate utilization of opioids and APAP, CMS is considering expanding it to benzodiazepines, skeletal muscle relaxants, amphetamine derivatives, and clinical treatment concerns such as concurrent use of central nervous system depressants and inappropriate concurrent use of HIV drugs. CMS seeks comments on which drugs or classes of drugs would be appropriate or inappropriate for OMS, insight on targeting methodologies, such as maximum dose, duplicative therapy or other principles of drug use review, to identify potential cases of overutilization or misuse of any drugs or classes of drugs identified. CMS also notes that sponsors may currently apply the Part D overutilization policy to non-opioids medications with appropriate document and written notice to beneficiaries when POS edits are made. This provision also seems to suggest that CMS is seeking ways to allow plans to better manage some medications in the 6 protected classes after efforts to relax requirements that plans cover all or substantially all medications in the protected classes were thwarted last year.

    Specialty Tiers and Deductibles (page 154)
    The specialty tier threshold remains at $600 in monthly spending. CMS does not make any other policy changes on this topic.

    Maximum Allowable Cost (MAC) Pricing (page 156)
    Effective on January 1, 2016, Medicare Part D plans must report MAC pricing to network pharmacies in advance. CMS does not set a time limit for advanced notice and also does not specify the manner in which the information must be communicated. CMS is concerned that Medicare Part D sponsors may send updates to network pharmacies with no particularly organization other than time order of pricing updates. In the draft call letter, CMS cautions Part D plans that MAC prices must be disclosed in a manner usable by pharmacies to allow validation of prices.

    Mail Order and Changes to Auto-Ship Policy (page 156)
    Beginning in 2016, CMS will allow Part D sponsors may offer automatic deliveries of new prescriptions without requesting an exception to the auto-ship policy by CMS. CMS indicates that plans must ensure that automatic shipments meet the requirements established in several memoranda issued on October 28, 2013, December 12, 2013, and March 21, 2014. This information is also outlined beginning on page 157 of the draft call letter.

    To read the call letter, visit here.

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