ALERT: CMS Issues Proposed Rule With Several LTC Implications

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November 2012

Please note: This sample Conflicts of Interest Disclosure Form is intended as a model to assist pharmacists in the development of conflict of interest disclosure forms. All Disclosure Forms should be personalized as Applicable And Reviewed by a legal advisor to ensure compliance with local and state law.

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CMS Publishes Response to Independence Proposal
The final rule for the Medicare Program Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2013 and Other Changes (PDF) was published in the April 12 Federal Register. This notice contains the Centers for Medicare & Medicaid Services’ (CMS) response to public comments received regarding their proposal to require consultant pharmacists to be independent from long-term care pharmacies, pharmaceutical manufacturers, and wholesalers. The section pertaining to consultant pharmacist independence begins on page 29 of the PDF, or page 22100 of the Federal Register Notice, "5.Independence of LTC Consultant Pharmacists (Sec.483.60)". (PDF)

Read ASCP President Penny Shelton's response to CMS proposal comments.

Summary of CMS decision on consultant pharmacist independence
CMS has decided not to finalize a requirement for consultant pharmacists to be independent from LTC pharmacies, pharmaceutical manufacturers, distributors or their affiliates at this time. However CMS remains convinced that problems associated with conflicts of interest persist throughout the LTC setting, and that broader changes beyond consultant pharmacist independence are necessary in order to ensure patient safety and quality of care. CMS expects the full LTC industry to immediately take steps to improve transparency and reduce the prevalence of unnecessary drugs and drug overutilization in nursing facilities, particularly with respect to off-label use of atypical antipsychotics. CMS plans to implement requirements for nursing facilities to prevent problems associated with conflicts of interest in a future notice and comment rulemaking. In the interim, CMS solicits additional feedback from the public through a series of questions. Public comments are due 60 days from the date of publication in the Federal Register.

Proposed Rule

The Centers for Medicare and Medicaid Services (CMS) issued a proposed rule (link to excerpt) in early October 2011 entitled "Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2013 and Other Proposed Changes; Considering Changes to the Conditions of Participation for Long Term Care Facilities." The deadline for comments was 5 pm EST, December 12, 2011.

ASCP submitted comments to CMS (Summary (PDF) | Full text (PDF) ) on December 12, and will continue to update this page with information as it becomes available. Please send any additional feedback you may have to

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