The purpose of this memorandum is to provide guidance for the recognition of pharmacists as primary care providers (PCPs), also known as Clinical Pharmacy Specialists (CPSs).  Pharmacists designated as CPSs have medication prescribing authority and deliver primary care to eligible beneficiaries.

Pursuant to Sections 401 and 402 (25 U.S.C. 1641 and 1642) of Title IV, Public Law 94-437, as amended, certain health professionals may be designated as PCPs.  Pharmacists designated as CPSs are those pharmacists with a Doctor of Pharmacy degree (Pharm.D.), pharmacists who have completed a pharmacy residency program, specialty board certified pharmacists, pharmacists with other specialty certifications, or pharmacists with at least two years of equivalent clinical experience.

The Indian Health Service (IHS) provides high quality health care through the proper utilization of a number of highly qualified health care providers.  These health care providers include physician extenders from several disciplines, including pharmacists.  Consistent with the Food, Drug and Cosmetic Act, applicable regulations, and informal Food and Drug Administration guidance, the IHS will exercise its authority in defining inpatient and outpatient medication prescribing authority by expanding the role of qualified pharmacists to prescribe medications.  Controlled substance prescribing by pharmacists is authorized in the Indian Health Manual (IHM), Chapter Seven, Pharmacy, Section 3-7.3D(2a)(vi), and is limited to pharmacists licensed or registered in states that permit pharmacists to do so.

CPSs will be included in the IHS definition of a primary care provider for the purposes of workload reporting, program planning, and reimbursement from all third party payers.  An appropriate primary provider code will be assigned to CPSs.

The medical staff of each IHS facility will determine the scope of practice for CPS which will identify the individual's prescriptive authority as well as the routine and non-routine professional duties that will be performed.  State governments Area and Associate Directors may not regulate the activities of the Federal Government, or its employees, when acting within the scope of their Federal employment, except by congressional consent.  State laws and regulations relating to medication orders and prescriptions do not affect scope of practice statements under this policy.

Prescriptive authority will be granted to duly authorized pharmacist CPSs consistent with their approved scope of practice and will not require a physician cosignatory.  The scope of practice, including medication prescribing authority, for CPSs will be approved in writing by the facility clinical director.  Clinical privileges for CPS may be authorized via standing orders or the facility credentialing/privileging process.  All inpatient medication orders and outpatient prescriptions written by CPSs not specifically identified in their individual standing orders or credentials, must be cosigned by a physician prior to its being filled.

Each facility will implement a mechanism to recognize that the CPS and their prescriptive authority as providers of primary care.  Appropriate mechanisms to assure the implementation of and evaluation of the CPS will be developed by the local facility.