Independence of Consultant Pharmacists

Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2013

In October 2011, the Centers for Medicare and Medicaid Services (CMS) issued a proposed update to Medicare Parts C/D 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".

Within the discussion section, CMS highlights patient safety and quality of care concerns related to “contractual arrangements involving LTC facilities, LTC pharmacies, the LTC consultant pharmacists these pharmacies provide to LTC facilities, and pharmaceutical manufacturers and/or distributors.”

CMS proposes to require that consultant pharmacist services for LTC facilities be independent of any affiliation with LTC pharmacies, pharmaceutical manufacturers or distributors as a consideration of the Conditions of Participation for LTC facilities in the Medicare program. If implemented, consultant pharmacists could no longer be employed by LTC pharmacies, and instead would need to be employed by or contract with the LTC facilities.

Summary of CMS Concerns

In reviewing the drug regimen of LTC facility residents, consultant pharmacists make recommendations to prescribe, discontinue or change medications to promote optimal care and health outcomes, following a professional Code of Ethics, as highlighted by the American Society of Consultant Pharmacists (ASCP). Although it is ultimately the decision of the resident's physician to alter a medication regimen, CMS states that steering by consultant pharmacists could result in the overprescribing of medications, the prescribing of drugs that are inappropriate for LTC residents or the use of unnecessary or inappropriate therapeutic substitutions if financial arrangements influence the consultant pharmacist's clinical decision-making. CMS states that, "although they have no evidence directly linking these arrangements to adverse outcomes," separating the consulting pharmacists from the LTC pharmacies would be appropriate and prudent as it would ensure that financial arrangements did not influence the pharmacist's clinical decision making to the detriment of LTC facility residents.

CMS states that while LTC pharmacy relationships with consultant pharmacists are not directly connected to research findings showing an overuse of antipsychotics within the nursing home population, “it is reasonable to presume that the incentives present in the relationships among consultant pharmacist, LTC pharmacies and drug manufacturers can influence the prescribing practices reflected in these data.”

CMS Proposal

CMS is considering requiring that LTC consultant pharmacists be independent of any affiliations with LTC pharmacies, pharmaceutical manufacturers and distributors, or any affiliates of these entities.

CMS is considering requiring that LTC facilities employ or directly/indirectly contract for the services of a licensed pharmacist who is independent, defining "independent” to mean that the pharmacist must not be employed, under contract, or otherwise affiliated with the facility's pharmacy, a pharmaceutical manufacturer or distributor, or any affiliate of these entities. The changes would also prohibit nursing homes from contracting for the provision of consultant pharmacy services with entities (such as a subsidiary of an LTC pharmacy) that have been created for the purpose of providing reorganized consultant pharmacist services.

LTCPA Position

Industry Positions