CMS will not require independent LTC pharmacists

by Ruta Kadonoff, Vice President, Quality & Regulatory Affairs, American Health Care Association

In a welcome response to comments submitted by AHCA and other stakeholder groups, The Centers for Medicare and Medicaid Services (CMS) reported on April 2 that they will not move forward in the immediate term with a proposal to require LTC facilities to hire independent consultant pharmacists, while reserving the possibility of doing so in the future if reductions in “inappropriate prescribing,” including the off-label use of antipsychotic drugs, are not observed. This decision was reflected in a final rule with comment period for the Medicare Advantage and prescription drug benefits programs for Calendar Year 2013.

In an October, 2011 Federal Register Notice, CMS discussed a potential new requirement for LTC consultant pharmacists to be independent of any affiliations with the facility's pharmacies, pharmaceutical manufacturers and distributors, or any affiliates of these entities. CMS reasoned that such a requirement was necessary to ensure that consultant pharmacist decisions were objective, unbiased, and in the best interest of nursing home residents. CMS now indicates that, “From comments received on this issue, we now believe a more targeted and less disruptive approach is warranted.”

In December 2011, AHCA submitted comments to CMS on this proposal, which the AHCA Pharmacy Workgroup was instrumental in shaping. In those comments, AHCA agreed that it is important to minimize the potential for a conflict of interest on the part of the consultant pharmacist and argued that current regulations and Guidance to Surveyors provides adequate support for CMS to deal with potential conflicts. AHCA also provided 6 alternative suggestions to minimize potential conflict of interest, provided data from the one state that requires an independent pharmacist that suggests “independence” does not necessarily result in reduction of use of antipsychotics and listed (with supporting information) advantages to having the consultant pharmacist associated with the dispensing pharmacy.

CMS is now soliciting additional comments to help determine a more comprehensive approach to eliminate overprescribing and reduce the use of antipsychotic drugs in LTC. CMS also strongly encourages the LTC industry to voluntarily adopt the following changes to increase transparency:

• Separate LTC consultant contracting for dispensing and other pharmacy services;

• Pay fair market rates for consultant pharmacist services; and

• Disclose to LTC facilities any affiliations of consultant pharmacists that pose potential conflicts of interest (this may include the execution of consultant pharmacist integrity agreements.)

CMS adds that if the expected improvements in prescribing behavior and antipsychotic drug use do not occur through voluntary practice changes, they will use a future notice and comment rulemaking to propose requirements to comprehensively address these concerns.