Below you will find some excerpts of critical sections of the rule that impact consultant pharmacists. Return to the LTC Rule home page.
Independence of LTC Consultant Pharmacists - Preamble Section II.B.5 (Sec. 483.60) (Begins on Page 63038)
We are greatly concerned with financial arrangements that involve payments from pharmaceutical manufacturers directly or indirectly to LTC pharmacies and LTC consultant pharmacists for encouraging physicians to prescribe the manufacturer's drug(s) for residents. The impact of these financial incentives is heightened when, as permitted under State law or by the State Pharmacy Board, LTC facilities sign agreements with LTC pharmacies permitting the consultant pharmacists to make medication switches. These types of arrangements may result in incentives for the LTC consultant pharmacist to make recommendations that conflict with the best interests of nursing home residents, as well as with Part D sponsors' formularies and/or drug utilization management (DUM) programs. Any such arrangements have the potential to directly or indirectly influence consultant pharmacist drug regimen recommendations. As a result, the arrangements bring into question the ability of the LTC consultant pharmacists to provide impartial reviews of the residents' drug regimens, which in turn raises concerns regarding the quality of those reviews and potential impact on resident health and safety.
We believe severing the relationship between the consultant pharmacist and the LTC pharmacy, pharmaceutical manufacturers and distributors, and any affiliated entities would further protect the safety of LTC residents because it will ensure that financial arrangements do not influence the consultant pharmacist's clinical decision making to the detriment of LTC residents.
Therefore, we are considering requiring that LTC consultant pharmacists be independent of any affiliations with the LTC facilities' LTC pharmacies, pharmaceutical manufacturers and distributors, or any affiliates of these entities. For the reasons described in this section, we believe such a requirement is necessary to ensure that consultant pharmacist decisions are objective and unbiased. That is, LTC facilities must use a qualified professional pharmacist to conduct drug regimen reviews and make medication recommendations based solely on what is in the best interests of the resident.
We believe this can be achieved only if the consultant pharmacist is working without the influence of conflicting financial interests that might otherwise encourage overprescribing and overutilization, which creates health and safety risks for residents.
REQUEST FOR COMMENT
We are considering requiring that long term care facilities employ or directly or indirectly contract the services of a licensed pharmacist who is independent.
We also are considering including a definition of the term "independence” to mean that the licensed 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. Our 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.
We do not intend, however, for any of the changes under consideration to prohibit any relationships that would be inherently free of conflict of interest. Thus, we solicit comment on the specific relationships that should be permitted.
[W]e are thinking of including an exception for Tribal owned LTC facilities and pharmacies. We also solicit comment from the public on our interpretation that in these unique situations independence is not an issue because the risk of conflicts of interest is sufficiently limited.
[W]e are soliciting comment on whether to provide for a later effective date for rural facilities as opposed to other LTC facilities or to make other accommodations for the unique circumstances in which rural facilities operate.
[W] are also soliciting comments on whether it would make sense to waive the independence requirement to permit alternative approaches. In describing these other approaches, comments should address the protections that would be implemented to reduce the risk of conflict of interest due to the lack of independence of the consultant pharmacists.
[A]lthough we are not proposing in this rule to codify changes to the drug regimen review requirements, we are soliciting public comment on best practices related to the conduct of drug regimen reviews. We will use these comments to inform possible future rulemaking regarding the drug regimen review requirements.
In verbal conversations with industry representatives, we have been informed that LTC pharmacies typically provide the consultant pharmacists to nursing homes at rates that are well below the LTC pharmacy's cost and below fair market value.
Although we have no evidence directly linking these arrangements to adverse outcomes, we believe a requirement under consideration that LTC consulting pharmacists be independent would be appropriate and prudent because it would ensure that financial arrangements did not influence the consultant pharmacist's clinical decision making to the detriment of LTC residents. Our concerns are not merely theoretical. We are aware of claims brought by qui tam relators under the False Claims Act alleging that, for instance, an LTC pharmacy received quarterly payments styled as rebates from the pharmaceutical manufacturer to engage in an active intervention program to convince physicians to prescribe a manufacturer's antipsychotic agent to the physicians' nursing home patients and to authorize all competitive products only after the failure of the manufacturer's product. In 2005, the Food and Drug Administration (FDA) issued warnings of the increasing death rate associated with the use of antipsychotic agents for behavioral symptoms for older persons with dementia. In reporting the results of 17 clinical trials, FDA noted an approximately 1.6 to 1.7 fold increase in mortality, compared to placebo-treated patients, in these studies.1 Thus, any financial arrangements that encourage consultant pharmacists to prescribe these drugs to older LTC residents with dementia contrary to FDA warnings may detrimentally affect those residents' health and safety.
In addition to research findings, nursing home survey and certification data reported in the CMS online survey and certification reporting system indicate unnecessary drug use in nursing homes continues to be a problem. In 2006, we issued updated guidance for LTC survey and certification reviews of the use of potentially unnecessary medications. The guidance, providing specific information on medications that are problematic to the nursing home population, was implemented in December 2006. In the 7 years prior to the implementation, the percent of surveys with a citation for unnecessary drug use ranged from 12.6 to 14.0 percent. Since implementation, however, the percent of surveys with these citations has increased yearly from 18.2 percent in 2007 to 19.4 percent in 2009.
The research and our survey and certification data indicate that the use of unnecessary medications, particularly antipsychotics, is problematic in LTC facilities. Although our findings do not directly connect LTC pharmacy relationships with consultant pharmacists to these research findings and survey results, we believe 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.