Lack of definitions, both for the businesses and the medical professionals within specialty pharmacy, creates an opportunity
The next phase in the ongoing evolution of specialty pharmacy seems about to commence—but who will be driving it is up for grabs. Last fall, the National Assn. of Specialty Pharmacy (NASP; Odessa, FL) came into being. Then, this winter, the Specialty Pharmacy Assn. of America (SPAARx), organized by Armada Health (Florham Park, NJ), a private company that provides purchasing and support services to specialty organizations (including pharmacies), started up. It will be unveiled at the company’s annual Armada Summit (Las Vegas, May 7-10).
Just as NASP was coming together, its executive director, Gary Cohen, RPh, was also organizing a Specialty Pharmacy Certification Board, which now has participation from such specialty organizations as CVS Caremark, Walgreens, US Bioservices (part of AmerisourceBergen Specialty Group) and Diplomat Pharmacy. The purpose of SPCB is to develop certifications for specialty pharmacist, nurses and other health professionals. The effort has some muscle behind it: It has joined the Institute for Credentialing Excellence, and that organization, in turn, is affiliated with the American National Standards Institute. ANSI is well recognized by many federal agencies. (Note, however, that NASP has yet to be granted an ICEE-approved certification process.)
Missing from this effort is the American Pharmacists Assn. (APhA; Washington, DC), which has a subsidiary organization, the Board of Pharmacy Specialties. BPS has been around since 1976, and has developed standards and tests for eight specialties so far, such as nuclear pharmacist, oncology pharmacist and pediatric pharmacist. But when asked whether BPS will credential “specialty pharmacist,” William Ellis, executive director, stated flatly, “BPS will not be pursuing certification in the specialty pharmacy arena at this time.”
In a word, a “specialty pharmacist” is not a “pharmacy specialist.” Generally speaking, pharmacists are licensed and credentialed by the state they work in; each state has its own Board of Pharmacy that regulates the profession. The specialist credential, at least in the APhA context, is something in addition to basic licensure.
What is a specialty pharmacy?
The professional credentialing, which is important in its own right, is also a steppingstone to what defines a specialty pharmacy—presumably, specialty pharmacies are places where specialty pharmacists work. Both NASP and SPAARx have efforts under way to define “specialty pharmacy,” which, although increasingly important to dispensing medicines, has little or no regulatory structure undergirding it. (The same is true, more or less, for “specialty pharmaceutical,” which is only characterized by CMS as costing more than $600 per month.)
All this fuzziness needs to be resolved. There have already been a few instances where industry or professional groups have petitioned CMS to define “specialty pharmacy,” in part because, for instance, reimbursements to them for some types of patient support services may or may not be part of how Average Manufacturer Price (AMP) is defined. “Class of trade” definitions, mostly important in commercial contracts but also having some regulatory impact, are also in play. “In my opinion, a pharmacist credential should come from an existing professional organization, and I’ll leave it at that,” says one industry insider. “The pharmacy profession is staring at a future where they will mostly be dispensing $4-per-month generics, while branded products will mostly be in the specialty space.”