In its October 11, 2011 Proposed rule (76 FR 63018), CMS reported that it was considering a provision requiring long-term care (LTC) consultant pharmacists to be independent of any affiliations with the facility’s pharmacies, pharmaceutical manufacturers and distributors, or any affiliates of these entities.
However, in its April 12, 2012 Final rule with comment period (77 FR 22072), CMS has decided that this proposed requirement will not provide the solution to over-prescribing of drugs and the use of chemical restraints in LTC settings it had hoped for. As a result, CMS is not finalizing this aspect of its Proposed rule but, instead, is asking for additional comments to help determine a more comprehensive approach to these issues.
What are the Regulatory Requirements for LTC Facilities?
Under the Social Security Act, LTC facilities must provide for pharmaceutical services to meet the needs of each resident. This requirement is codified at 42 C.F.R. §483.60, which requires LTC facilities to employ or obtain the services of a licensed pharmacist to provide consultation on all aspects of the provision of pharmacy services in the facility, including a drug regimen review at least once a month for each facility resident.
Do Common LTC Industry Practices Create Conflicts?
In its Proposed rule, CMS noted that nursing homes commonly contract with a single LTC pharmacy for prescription drugs for facility residents and very often the same LTC pharmacy also contracts with the facility to provide consultant pharmacists for required consultation on all aspects of the provision of pharmacy services in the facility, including the monthly resident drug regimen reviews. CMS also indicated that some LTC pharmacies provide the consultant pharmacists to nursing homes at rates that may be below the LTC pharmacy’s cost and below fair market value. Such arrangements have the obvious potential to directly or indirectly influence consultant pharmacist drug regimen recommendations, resulting in (1) over prescribing of medications, (2) the prescribing of drugs that may be inappropriate for LTC or geriatric residents, or (3) the use of unnecessary or inappropriate therapeutic substitutions.
What Was CMS Hoping to Achieve Through its Proposed Rule?
CMS hoped that severing the relationship between the consultant pharmacist and the LTC pharmacy, pharmaceutical manufacturers and distributors, and any affiliated entities would protect the safety of LTC residents because it would ensure that financial arrangements would not influence the consultant pharmacist’s clinical decisions.
As a result, CMS suggested requiring that LTC facilities employ or directly or indirectly contract the services of a licensed pharmacist who is independent. CMS also suggested 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.
CMS also noted its understanding that some LTC consultant pharmacists may perform approximately 60 drug regimen reviews in a day. CMS suspected that this rate might be too high, given its expectation that independent consultant pharmacists would conduct more thorough drug regimen reviews, monitoring for drug side effects and effectiveness.
After Further Consideration – What Does CMS Believe?
After considering the comments received from industry and the public on its Proposed rule, CMS now believes a more targeted and less disruptive approach is warranted, at least initially.
In it Final rule with comment period, CMS indicates that it agrees with the recommendation that LTC facilities pay a fair market rate for consultant pharmacist services; noting that the Office of Inspector General (OIG) has stated that provision of consultant pharmacists’ services by LTC pharmacies at below market rates “present[s] a heightened risk of fraud and abuse” (OIG Supplemental Guidance Program for Nursing Facilities, 73 FR 56832, 56838, note 53, September 30, 2008). CMS, however, does not believe it is within its statutory authority to require provision of such services at market rates.
CMS also indicates that it considered requiring that LTC facilities separately contract for consultant pharmacist services from other pharmacy services and that consultant pharmacists disclose to the LTC facility, the medical director, ombudsmen, and residents upon request any affiliations that would pose a potential conflict-of-interest risk. However, CMS believes that any such requirements cannot be finalized in its Final rule with comment period, since it did not propose them initially.
As a result, since it has determined that a requirement for independent consultant pharmacists will not solve the entire problem, but would be significantly disruptive for much of the LTC industry, CMS is not finalizing this provision at this time. Instead, CMS is soliciting additional comments to help it determine a more comprehensive approach to eliminate overprescribing and the use of chemical restraints in LTC.
In the Meantime – What Should the LTC Industry Do?
In the meantime, given CMS’ continuing conflict of interest concerns, it strongly encourages the LTC industry to voluntarily adopt the following changes to increase transparency: (1) separate contracting for LTC consulting services from dispensing and other pharmacy services; (2) payment by LTC facilities of a fair market rate for consultant pharmacist services; and (3) disclosure by the consultant pharmacists to the LTC facility of any affiliations that would pose a potential conflicts of interest or the execution by the consultant pharmacists of an integrity agreement.
What Will CMS Focus On Going Forward?
Until the next opportunity for it to propose a regulatory change, CMS plans to closely evaluate the number of deficiency citations for unnecessary drug use and will monitor the two new performance measures to track the use of antipsychotics in LTC facilities and expects to see significant improvement.
CMS will also continue to participate in a Department of Health and Human Services (DHHS) initiative focused on the use of antipsychotics for persons with Alzheimer’s disease. As part of this effort, CMS hopes to eliminate the inappropriate use of antipsychotic drugs in LTC facilities for residents with Alzheimer’s disease through updated guidance on the use of these medications and stricter enforcement of current requirements.
CMS further believes that effort focused on eliminating the use of inappropriate chemical restraints for LTC facility residents with Alzheimer’s disease may also serve to improve the quality of care for the LTC facility residents with the behavior symptoms associated with dementia.
General Comment Categories and Specific CMS Concerns
CMS is soliciting further comment to assist it in better defining the problem and framing a more comprehensive solution to address our concerns regarding medication management and quality in LTC. Generally, CMS is soliciting comments related to (1) enhancing medication management and effectiveness of medication review; (2) data collection and use; and (3) increasing transparency.
Some very specific concerns CMS is seeking comment on include the following:
What actions should be taken to strengthen attending physician medication management and prescribing practices to ensure the best quality of care for the nursing home resident?
- What actions could be undertaken to establish and ensure the independence and effectiveness of a consultant pharmacist in conducting their medication reviews on behalf of nursing home residents?
- What data are needed to enable and support the Medicare and Medicaid programs and others in monitoring the appropriateness and adequacy of medication management activities, including the use of antipsychotics drugs?
- What data are needed to create public performance metrics regarding the independence of consultant pharmacists and prescribers from pharmacies and drug manufacturers and distributors?
- What specific details regarding the financial arrangements between LTC facilities, consultant pharmacists, and LTC pharmacies providing consulting and dispensing services should be disclosed, and to whom should this information be available?
- What metrics could be used to assess the adequacy and appropriateness of prescriber response to consultant pharmacist recommendations?
Industry and public comments on the independence of LTC consultant pharmacists are due by June 11, 2012.