The Office of General Counsel issued the following opinion on June 22, 2004, representing the position of the New York State Insurance Department.

Re: Utilization Review, Pharmacist as Clinical Peer Reviewer

Question Presented:

Will the Department modify its February 27, 2004 opinion that a pharmacist may not serve as a clinical peer reviewer for prescription drug claims, as that term is defined in New York Insurance Law Article 49 (McKinney 2000)?

Conclusion:

The Department will not change its position that New York Insurance Law Article 49 does not permit a pharmacist to serve as a clinical peer reviewer for prescription drug claims.

Facts:

By letter, the Department indicated that a pharmacist could not serve as a clinical peer reviewer, as that term is defined in New York Insurance Law Article 49. It was questioned whether the Department would reconsider its February 27, 2004 opinion.

Analysis:

New York Insurance Law § 4900(b) (McKinney 2000) provides:

"Clinical peer reviewer" means:

(1) for purposes of title one of this article:
...
(B) a health care professional other than a licensed physician who:

(i) where applicable, possesses a current and valid non-restricted license, certificate or registration or, where no provision for a license, certificate or registration exists, is credentialed by the national accrediting body appropriate to the profession; and

(ii) is in the same profession and same or similar specialty as the health care provider who typically manages the medical condition or disease or provides the health care service or treatment under review; . . .

New York Insurance Law § 4900(f) (McKinney 2000) provides:

"Health care professional" means an appropriately licensed, registered or certified health care professional pursuant to title eight of the education law or a health care professional comparably licensed, registered or certified by another state.

Licensure pursuant to New York Education Law Title VIII (McKinney 2001 and 2004 Supplement) is one requirement to consider under New York Insurance Law § 4900(b)(1)(B) in ascertaining whether a health care professional can qualify as a clinical peer reviewer. Pursuant to New York Insurance Law § 4900(b)(1)(B)(ii), in order to be a clinical peer reviewer, the pharmacist would also have to be "in the same profession and same or similar specialty as the health care provider who typically manages the medical condition or disease or provides the health care service or treatment under review."

There are numerous distinctions between a physician and a pharmacist. The practice of pharmacy is defined in New York Education Law § 6801 (McKinney 2001):

The practice of the profession of pharmacy is defined as the preparing, compounding, preserving, or the dispensing of drugs, medicines and therapeutic devices on the basis of prescriptions or other legal authority.

This is contrasted with the definition of the practice of medicine, New York Education Law § 6521 (McKinney 2001):

The practice of the profession of medicine is defined as diagnosing, treating, operating or prescribing for any human disease, pain, injury, deformity or physical condition.

The issue presented is the medical necessity of the prescribed drug. While a pharmacist may have "independent and specialized knowledge, skill and professional judgment," as to whether a particular drug has efficacy for a condition, such a professional does not have the ability to examine a particular person and prescribe a drug given his or her unique medical circumstances. Simply put, authority to make such a medical necessity determination is not conferred upon a pharmacist. Thus, pharmacists should not be reviewing decisions that they cannot, nor are qualified to, make in the first instance.

Accordingly, a pharmacist is not in the "same profession and same or similar specialty as the health care provider who typically manages the medical condition or disease or provides the health care service or treatment under review," in this case, the physician who has prescribed a particular drug for a particular patient.

The fact that pharmacists work under the direction of a Ph.D. in Pharmacology does not change the Department’s conclusion. Pharmacology is defined, American Heritage Dictionary of the English Language, 4th Edition (2000):

(1) The science of drugs, including their composition, uses and effects. (2) The characteristics or properties of a drug, especially those that make it medically effective.

While the pharmacologist may be more qualified than an ordinary pharmacist to opine on drug interactions, pharmacologists also do not have the authority to examine patients nor prescribe drugs and thus, are also not in the "in the same profession and same or similar specialty as the health care provider who typically manages the medical condition or disease or provides the health care service or treatment under review."

It was argued that the Department's opinion is in opposition to Lutz v. Houck, 263 N.Y. 116 (1933), and Anonymous v. CVS Corporation, 188 Misc 2d 616, 728 N.Y.S. 2d 333 (Sup. Ct. New York Cnty. 2001), affd. 293 App. Div. 2d 285, 739 N.Y.S. 2d 565 (1st Dept 2002). Neither decision is relevant to the issue at hand. Indeed in CVS, while acknowledging that pharmacists have access to patients’ confidential medical information, the court stated that the role of a pharmacist is distinct from that of a physician treating a patient. 728 N.Y.S. at 623.

Further, while under N.Y. Codes Rules & Regs. tit. 8, 63.6(b)(8)(ii)(d) a pharmacist may, in rare circumstances, refuse to fill a prescription if it would endanger a patient’s health, this regulation does not elevate the role of a pharmacist to the role of a physician who, under all circumstances, can make a medical necessity determination as to what drugs can best treat a patient given his or her unique medical situation.

Based upon the above, this Department's February 27, 2004 conclusion that a pharmacist may not serve as a clinical peer reviewer for prescription drug claims, as that term is defined in New York Insurance Law § 4900(b), remains unchanged.

For further information Deputy Superintendent and General Counsel Audrey Samers may be contacted at the New York City Office.