                              ATTORNEY GENERAL OF TEXAS
                                           GREG       ABBOTT




                                            November     17,2004



The Honorable Wayne Smith                            Opinion No. GA-0271
Chair, Committee on County Affairs
Texas House of Representatives                       Re: Whether health care providers administering
Post Oftice Box 2910                                 vaccinations in hospitals under the federal Medicare
Austin, Texas 78768-2910                             program are immune from liability for injuries
                                                     caused by the vaccine (RQ-0227-GA)

Dear Representative     Smith:

        You ask whether health care providers administering vaccinations in hospitals under the
federal Medicare program are immune from liability for injuries caused by the vaccine.’

        You indicate that the Centers for Medicare and Medicaid Services (“CMS”), a federal
agency, formulates guidelines known as “Conditions of Participation” (“Cops”) that health care
providers must meet in order to participate in the federal Medicare program. See Request Letter,
supra note 1, at 1. “Recently, CMS removed from its COPS the requirement that in a hospital setting,
a physician must write an individual order for each inff uenza and pneumonia vaccination given to
his or her patients     .” Id. Vaccines may now be “administered based on a physician-approved
hospital protocol for a standing order after an assessment of contraindications.” Id. at 2.

         Although preventative vaccines are a covered benefit under Medicare, and “CMS studies
have shown that the use of standing orders is the most effective way” to increase the vaccination rate
among elderly patients, the administration of these vaccines “is not a common procedure in
hospitals.” Id. Many hospital physicians are hesitant to prescribe immunizations “because of the
looming threat of unknown liability for injuries that may come from the procedure.” Id. Section
161.001(a) of the Health and Safety Code attempts to limit this liability under particular
circumstances.   You ask whether immunizations for the elderly in a hospital setting under CMS
guidelines are within the exemption from liability authorized by section 161.001(a).

Section 161.001 of the Health and Safety Code provides:

                 (a) A person who administers or authorizes the administration of a
                 vaccine or immunizing agent is not liable for an injury caused by the



          ‘See Letter from Honorable     Wayne Smith, Chair, Committee on County Affairs, Texas House of
Representatives, to Honorable Greg Abbott, Texas Attorney General (May 17,2004) (on tile with Opinion Committee,
also available at www.oag.state.tx.us) [hereinafter Request Letter].
The Honorable Wayne Smith - Page 2             (GA-0271)




               vaccine or immunizing agent if the immunization      is required by the
               board or is otherwise required by law or rule.

TEX. HEALTH&SAFETY CODE ANN. $161.001(a) (Vernon 2001). “Board” is defined for purposes
of title 2 of the Health and Safety Code, of which chapter 161 is a part, as the “Texas Board of
Health.” Id. 5 11.001. For this immunity to apply, we have to determine whether it is required by
the Board or otherwise required by law or rule.

        You do not indicate that the Board itself requires immunizations for Medicare participants
in a hospital setting. You suggest, however, that the COPS implicitly require such immunizations.
Section 482,23(c)(2) of title 42 of the Code of Federal Regulations provides, in relevant part:

               (2) All orders for drugs and biologicals must be in writing and signed
               by the practitioner or practitioners responsible for the care of the
               patient as specified under § 482.12(c) with the exception of influenza
               and pneumococcal polysaccharide vaccines, which may be
               administered per physician-approved hospital policy after an
               assessment for contraindications.

42 C.F.R. 5 482.23(c)(2) (2003) (emphasis added). Neither this provision nor any other federal
statute or regulation that we have found specifically requires that influenza and pneumococcal
polysaccharide vaccinations be administered. Nor do we believe that such a requirement may be
inferred from the language of section 482,23(c)(2).

        Neither does any Texas statute require immunizations of elderly persons in a hospital setting.
By contrast, section 161.0051 of the Health and Safety Code states that “[tlhe board by rule shall
require nursing homes to offer, in accordance with an immunization schedule adopted by the board:
(1) pneumococcal vaccine to elderly residents; and (2) influenza vaccine to elderly residents and to
staffwho are in contact with elderly residents.” TEX. HEALTH& SAFETYCODE ANN. 5 161.0051(c)
(Vernon 2001). Moreover, other statutes direct that “[hlospitals shall be responsible for
administering needed vaccinations” to children or “referring the child for immunization.”           Id.
5 161.004(b)(3) (Vernon Supp. 2004-05). These provisions indicate that when it wishes to require
immunizations for specific categories ofpersons, the legislature knows how to do so. It has not done
so with regard to Medicare patients in a hospital setting.

         As we have noted, section 161.001 of the Health and Safety Code limits liability for persons
who administer vaccines or immunizing agents only where “the immunization is required by the
board or is otherwise required by law or rule.” Id. § 161.001(a) (Vernon 2001). This office, like
the courts, is obliged to give effect to legislative intent. See City of San Antonio v. City ofBoerne,
111 S.W.3d 22,25 (Tex. 2003). To ascertain such intent, we first look to the plain and common
meaning of each word of the statute. See id. “If a statute’s meaning is unambiguous, we generally
interpret the statute according to its plain meaning.” Id. “When the purpose of a legislative
enactment is obvious from the language of the law itself, there is nothing left” to construe.
Fitzgerald v. Advanced Spine Fixation Sys., Inc., 996 S.W.2d 864, 866 (Tex. 1999).

        We conclude that section 161.001(a) of the Health and Safety Code does not provide
immunity from liability for persons who administer vaccines or immunizing agents in a hospital
setting to individuals covered by the federal Medicare program.
The Honorable Wayne Smith - Page 3           (GA-0271)




                                      SUMMARY

                       Section 161.001(a) of the Health and Safety Code does not
               provide immunity from liability for persons who administer vaccines
               or immunizing agents in a hospital setting to individuals covered by
               the federal Medicare program.

                                             Very truly yours,


                                          /&&J&fi~
                                             Attorney General of Texas



BARRY R. MCBEE
First Assistant Attorney General

DON R. WILLETT
Deputy Attorney General for Legal Counsel

NANCY S. FULLER
Chair, Opinion Committee

Rick Gilpin
Assistant Attorney General, Opinion Committee
