In early October, CMS released a set of proposed new rules governing Medicare Part D-related issues, including relationships among pharmacies, pharmacists and other entities.  There is a 60-day period for open comments and concerns to be submitted before a final rule is promulgated.   You can read and comment on the full text of the proposed rule here.

Probably most relevant to LTC is the controversial change that would require skilled nursing facilities to hire their own "independent" consultant pharmacists to perform monthly (and as-needed) medication regimen reviews, instead of the current common practice where a facility's contracted dispensing pharmacy provides the services of a consultant pharmacist as part of the services they render.  CMS is "very concerned" that the current system has the potential to create a conflict of interest.  
 
The American Society of Consultant Pharmacists has announced their opposition to the proposed change in consultant pharmacist status, and AMDA and AHCA are considering what position to take.  Clearly, none of our organizations want to perpetuate a situation where conflict of interest is suspected.  However, in my discussions with many physicians, pharmacists and other LTC professionals nationwide, I have never heard anyone identify a specific case where a consultant pharmacist has acted with apparent conflict of interest—although certainly they do make us aware of alternatives to medications when there are a variety of differences, be they safety, cost, formulary issues, or other factors.  Interestingly, the seeming origin of this recommendation from CMS is somebody's misguided notion that consultant pharmacists have encouraged physicians to use more antipsychotics, and that is why they are "so over-utilized" in LTC.   Somebody's conspiracy theory about back-room deals among  pharmacy benefit managers, big pharma, government cronies, and the monopolistic major players in LTC pharmacy resulting in us physicians being brainwashed to prescribe chemical restraints to everyone is what basically got this rolling.  I think any of us who work in this setting can confidently state that with respect to antipsychotics, the only message we have ever gotten from consultant pharmacists is, "Please do a gradual dose reduction" or "Can this drug be discontinued?" 

What the bureaucrats behind this latest initiative fail to see is that by making an individual facility (or chain) hire its own consultant pharmacist, it is going to create a still greater conflict of interest!  On a micro-level at the specific building budget line-item level, does anyone really think the facility is going to reward a pharmacy consultant who recommends more expensive drugs for their Part A residents (like, for example, Pradaxa in place of Coumadin)?   Many similar examples can easily be invoked by anyone even remotely involved in LTC and medications. 

Virtually all of the physicians I have spoken to have been satisfied or downright pleased with the professionalism and diligence of the consultant pharmacists under our current system.  They do their best to keep our facilities in compliance with the regulations, and they try to identify medications and interactions that place our residents at risk.  If they are also keeping fiscal concerns in mind, that is certainly understandable—and certainly something that will also be, if anything, more carefully scrutinized by the new "independent" pharmacy consultants envisioned under CMS' proposal.   This is another example of a proposed fix that won't fix anything.  So far I have seen no evidence of anything harmful befalling any patient as the result of the "potential" conflict of interest with pharmacy consultants who work for the big pharmacy providers.  Plus, with all of the budget cuts and the increasing difficulty making ends meet as an LTC operator, I don't know who is going to be expected to pay the going rate for a pharmacist to carefully review each and every chart.  But I do know these pharmacists who come to our buildings, and so do you.  They are doing fine.  My opinion is:  It's not broken, so let's not fix it. 

Comment from Tom Clark

Note that the American Society of Consultant Pharmacists has NOT announced opposition to the proposed change. ASCP is still receiving input from members on this controversial issue and this will be a topic of discussion at our Annual Meeting in Phoenix later this month. Thanks.

Thomas R. Clark, RPh, MHS, CGP
ASCP Director of Clinical Affairs

Comment from Pam Schuster

Dear Dr. Steinberg, I totally agree with everything you said above. I have been a consultant pharmacist for 15+ years. I have always felt in my heart that the protection of the resident was my mission. Having said that I also have felt that the harder I work the less it benefits the pharmacy because I ask to reduce doses and take residents off medications way more often then to request a medication be added. So while the current system may not be broken it is less that perfect.

Comment from Dan Osterweil, MD, FACP, CMD

I read with interest the commentary of Dr. Steinberg. Interesting and thought provoking as it is, the proposed idea to require independent pharmacists as consultants is not new. Other States such as New Jersey have mandated similar relations for a long time. The issue is a bit controversial from the pharmacist perspective. Reviewing the question of potential conflict interest and the status of pharmacy consultants as independent practitioners is the core of the issue debated. As it stands today in California the nursing home pays a fee for consultants' services. Those fees are negotiated per charts. The enumeration the contracting pharmacy pays the consultants is an hourly rate prevailing in the community. The dispensing pharmacy views the service as added value and is not necessarily counting on it as a cost center. They may be recouping some of the differential through some of the consultant's activities. Consultants through the course of their reviews may identify utilization patterns and may imbed in their drug regiment comments recommendations for conversion of brands to generics or vice versa. They may list certain medications as recommended in certain conditions many resulting in additional revenue to the dispensing arm of the business. The real concern of the pharmacy consultants should be that their hourly rates may be adversely affected by contracting directly with nursing homes. Nursing homes with already shrinking margins may exercise more scrutiny on their performance and time efficiency that may result in more work for less pay. Nursing homes would not be able to subsidize the consultants. So in my opinion, this proposed requirement may indeed break a potential link to what is perceived to be a potential conflict of interest. In doing so it may put at risk the pharmacy consultants income. However in the spirit of free enterprise it may create opportunity for business development and innovations. Whether it will improve care is entirely dependent on constructive collaboration between the prescribers and Nursing Home teams.

Comment from Karl Steinberg MD CMD

Thank you for the comments and the correction. The information I received about ASCP's position must have been premature. I apologize for not doing a more thorough fact-checking. We will see what is ultimately decided, and whether any of our input makes any difference.