BG C.S.H.B. 1284 75(R)BILL ANALYSIS PUBLIC HEALTH C.S.H.B. 1284 By: Van de Putte 4-10-97 Committee Report (Substituted) BACKGROUND Texas is ranked as one of the states with the highest number of children who have not been immunized. Some states have conducted pilot studies on the effect of children's immunization rates when pharmacists were allowed to administer vaccines. The results of these studies showed a dramatic increase in the number of children who were immunized. Currently in Texas, a few pharmacists administer flu vaccines and other immunizations in their pharmacies, under the provisions of Section 17(a)(5) of the Texas Pharmacy Act. This provision allows a pharmacist to administer medications when this action is delegated to a pharmacist by a physician. Because this is not a defined action of the practice of pharmacy, the administration of vaccines is not covered by a pharmacist's liability insurance. PURPOSE CSHB 1284 would allow pharmacists to administer immunizations as a part of the practice of pharmacy when ordered by a physician. RULEMAKING AUTHORITY It is the committee's opinion that this bill grants rulemaking authority in SECTION 2 to the State Board of Pharmacy (Section 17(y), Texas Pharmacy Act) and to the Texas State Board of Medical Examiners (Section 17(aa), Texas Pharmacy Act). Rulemaking authority is also granted to the Commissioner of Insurance in SECTION 3 (Article 21.53K, Sec. 2, Insurance Code). SECTION BY SECTION ANALYSIS SECTION 1. Amends Section 5(38), Texas Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes) by adding subsection (G) "administration of immunizations and vaccinations under a physician's written protocol," to the list of meanings under "practice of pharmacy." SECTION 2. Amends Section 17, Texas Pharmacy Act (Article 4542a-1, Vernon's Texas Civil Statutes) by amending Subsection (a) and adding Subsections (y), (z), and (aa) as follows: Subsection (a) adds language to include immunizations and vaccinations as types of medications which a pharmacist is allowed to administer using the specifications of conditions as specified. Adds language regarding a pharmacist possessing not only necessary skill and education, but also "certification as specified by the board" to administer medication. Adds that the pharmacist administers immunizations or vaccinations under a physician's written protocol and meets board established standards. Makes conforming changes to reletter some of the specifications. Subsection (y) requires the board, by rule, to require pharmacists to notify a physician who prescribes an immunization or vaccination within 24 hours of administering it. Requires the board to establish minimum education standards as specified. Subsection (z) establishes that physician supervision is adequate if a delegating physician is responsible for physicians orders as specified or protocols as specified; has referred a patient under 14 years of age with whom there is an established physician-patient relationship; is geographically indicated as specified; receives status reports as specified; and is directly available for communication as specified. Subsection (aa) requires the Texas State Board of Medical Examiners, by rule, to establish the minimum content of a written order or protocol. Establishes that the order or protocol may not permit delegation of medical diagnosis. SECTION 3. Amends Subchapter E, Chapter 21, Insurance Code, by adding Article 21.53K as follows: Art.21.53K. PROVISION OF SERVICES RELATED TO IMMUNIZATIONS AND VACCINATIONS UNDER MANAGED CARE PLANS Sec. 1. Prohibits a managed care entity from requiring a participating physician to issue an immunization or vaccination protocol as specified. Establishes that a managed care entity is prohibited from limiting enrollee immunization benefits as specified; from providing physicians financial incentives as specified; or from imposing penalties as specified. Sec. 2. Allows the commissioner to adopt rules to implement this article. SECTION 4. Establishes that this Act takes effect September 1, 1997. SECTION 5. Establishes that Article 21.53K, Insurance Code, as added by this Act, applies only to a managed care plan that is delivered, issued for delivery or renewed on or after January 1, 1998. A plan before that date is governed by existing law, which is continued in effect for that purpose. SECTION 6. Emergency Clause. COMPARISON OF ORIGINAL TO SUBSTITUTE The original bill in a single section, amended Section 17(a) of the Texas Pharmacy Act to state that the administering of immunizations by pharmacists was not prohibited. The substitute bill expands on that intention; it adds to the meaning of the "practice of pharmacy" under Section 5 of the Texas Pharmacy Act to enable pharmacists to administer immunizations and vaccinations. By including the capacity to administer immunizations within regulations regarding the "administration of medication" under jurisdiction of the State Board of Pharmacy, SECTION 2 of CSHB 1284 puts specific limitations and regulations on a pharmacist's ability and authority to administer immunizations. It also allows for promulgation of rules and establishment of minimum education standards and provides for written protocols through the Board of Medical Examiners. Additionally, the substitute bill adds SECTION 3 to prohibit a managed care organization from compelling any physician from establishing a written protocol for the purpose of directing pharmacists to perform immunizations and vaccinations. SECTION 5 has been added to explain the applicability and effective dates of this amendment of the Insurance Code on managed care plans.