CMS's proposed regulation for long-term care consultant pharmacists is stirring up controversy.
CMS cites reasons such as low rates of consultant pharmacist services that would entice a facility to enter into a pharmacy dispensing services arrangement and the purchase of prescription drugs from the pharmacy for the regulation. These reasonings, CMS states, coupled with "financial arrangements that involve payments from pharmaceutical manufacturers directly or indirectly to [LTC] pharmacies and consultant pharmacists for encouraging physicians to prescribe manufacturer's drug(s) for residents" could lead to steering of residents to certain drugs.
CMS added that the steering could result in overprescribing, prescribing that is inappropriate, and/or potential therapeutic substitutions that are unnecessary.
While critics share CMS's dedication in ensuring appropriate use of pharmaceuticals for residents of LTC facilities, and agree that ethical professional consulting pharmacist services are an important component in optimizing patient care, there is disagreement with CMS's contention that the requirement it is considering "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."
The opposition has voiced particular concern with respect to CMS's proposed definition of "independence." The current definition being considered by CMS appears to be very broad, and critics have asked that this definition be revised to limit its current and allegedly unworkable boundaries.
Other areas of concern include providing alternative approaches to CMS's proposal. At least 1 trade association, the American Society of Consultant Pharmacists, has called for: (i) separate contracts and payment provisions for consultant pharmacist and pharmaceutical services, (ii) payment for consultant pharmacist services provided at market-based rates that are based upon the true costs incurred for providing services, and (iii) an LTC pharmacy affirmation statement to the facility that the consultant pharmacist has authority to make independent judgments concerning appropriateness of medication therapy.
CMS's proposal has also been characterized as unnecessary since federal and state laws already exist to address the behaviors that CMS is attempting to curb. Prosecutions by the U.S. Department of Justice under the anti-kickback statute and federal False Claims Act have been previously invoked to address this behavior, according to critics.
Proceed with caution
Rather than proceed to formal rulemaking, the opposition has urged CMS to pause and undertake independent and appropriate studies to research alternative remedies that are less disruptive to the existing LTC pharmacy and consultant pharmacist delivery of care paradigm.
As a result of this disruption in the current construct, inferior patient quality of care is alleged to be a possible outgrowth, as there may be a subsequent decline in a sufficient number of qualified LTC pharmacists serving these patient facilities.
This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with attorneys familiar with the relevant drug and pharmacy laws.
Ned Milenkovich is a member at McDonald Hopkins, LLC, and chairs its drug and pharmacy practice group. He is also Vice-Chairman of the Illinois State Board of Pharmacy. Contact Ned at 312-642-1480 or at firstname.lastname@example.org