Are Texas hospitals protected from lawsuits if a Medicare patient is hurt by a flu or pneumonia vaccine given under a standing hospital order?

TX AG Opinion GA-0271: Hospital Vaccine Liability

Plain-English summary

A state legislator asked whether hospital staff who give Medicare patients flu or pneumonia shots under a federal "standing order," rather than an individual physician order for each patient, are shielded from liability if the vaccine injures someone. The federal Centers for Medicare and Medicaid Services had recently dropped the requirement that a doctor write an individual order for each flu and pneumococcal vaccination, letting hospitals instead vaccinate under a physician-approved standing protocol after checking for contraindications. Hospital doctors were reportedly reluctant to prescribe these vaccinations because of the liability exposure that change created.

The opinion concluded there was no state-law shield. Texas Health and Safety Code section 161.001(a) only protects someone who administers a vaccine when that immunization "is required by the board or is otherwise required by law or rule." Neither the federal Medicare Conditions of Participation regulation nor any Texas statute actually requires flu or pneumococcal vaccination of Medicare patients in a hospital setting; the federal rule only describes how such vaccines may be administered once a hospital chooses to offer them. Because nothing required the vaccination itself, the statutory condition for immunity was never met.

Currency note

This opinion was issued in 2004. Subsequent statutory amendments, court decisions, or later AG opinions may have changed the analysis. Treat this page as historical context, not current legal advice. Verify current law before relying on any specific rule, deadline, or remedy mentioned here.

Who this opinion affected (as of 2004)

Hospitals and the physicians who ordered vaccines under standing protocols: The opinion concluded that giving Medicare-covered flu or pneumococcal vaccines under a CMS-authorized standing order did not, by itself, trigger the liability immunity in section 161.001(a), because nothing required the vaccination to be given.

The Texas Board of Health: The opinion noted the Board had not required immunizations for Medicare participants in a hospital setting, and pointed out that where the legislature wanted immunizations required for a specific group, such as pneumococcal and influenza vaccines for nursing home residents and staff under section 161.0051(c), it said so expressly.

Legislators considering whether to close the gap: The opinion's holding turned entirely on the absence of a requirement in the CMS regulation or in Texas law; it identified that gap without recommending how or whether to fill it.

Common questions

Does a hospital get legal immunity just because it followed CMS's Medicare rules when giving a vaccine?
No. This 2004 opinion found that the federal Conditions of Participation regulation in effect at the time only described how a hospital could administer flu and pneumococcal vaccines under a standing order, it did not require the vaccination, and Texas Health and Safety Code section 161.001(a) only grants immunity when the immunization itself is required by the Board of Health or by law or rule.

Are there any Texas patients whose vaccinations are legally required, giving the provider immunity?
The opinion pointed to nursing home residents and staff under section 161.0051(c), where the Board of Health was directed by statute to require pneumococcal and influenza vaccine offers, and to certain child immunizations under section 161.004(b)(3), as examples of the legislature expressly requiring immunizations when it intended to.

Background and statutory framework

The Committee on County Affairs chair asked about a change CMS had made to its Medicare "Conditions of Participation," the federal standards hospitals must meet to participate in Medicare. CMS had removed the requirement that a physician write an individual order for each influenza and pneumococcal polysaccharide vaccination given in a hospital, allowing vaccines to instead be given under a physician-approved standing order after screening for contraindications, a change CMS believed would raise vaccination rates among elderly patients. The request explained that hospital physicians were hesitant to use standing orders because of uncertain liability exposure.

Texas Health and Safety Code section 161.001(a) exempts a person who administers or authorizes a vaccine from liability for an injury it causes, but only "if the immunization is required by the board or is otherwise required by law or rule." "Board" refers to the Texas Board of Health under title 2 of the Health and Safety Code. The opinion examined the CMS regulation, 42 C.F.R. section 482.23(c)(2), and found it did not require influenza or pneumococcal vaccination, it merely set the paperwork and protocol conditions under which those two vaccines could be given without an individual physician order. Applying ordinary rules of statutory construction, the opinion looked to the plain meaning of section 161.001(a) and concluded that because no Texas statute, board rule, or federal regulation actually required the vaccination of Medicare patients in a hospital setting, the statute's condition for immunity, that the immunization be "required," was not satisfied. The opinion contrasted this with section 161.0051(c), where the legislature expressly directed the Board to require nursing homes to offer pneumococcal and influenza vaccines to elderly residents and staff, and with section 161.004(b)(3), covering hospitals' duty regarding child immunizations, as instances where the legislature knew how to impose a requirement when it wanted to.

Citations

Statutes:

• Tex. Health & Safety Code Ann. § 161.001(a) (Vernon 2001)
• Tex. Health & Safety Code Ann. § 11.001
• 42 C.F.R. § 482.23(c)(2) (2003)
• Tex. Health & Safety Code Ann. § 161.0051(c) (Vernon 2001)
• Tex. Health & Safety Code Ann. § 161.004(b)(3) (Vernon Supp. 2004-05)

Cases:

• City of San Antonio v. City of Boerne, 111 S.W.3d 22, 25 (Tex. 2003)
• Fitzgerald v. Advanced Spine Fixation Sys., Inc., 996 S.W.2d 864, 866 (Tex. 1999)

Source

• Landing page: https://www.texasattorneygeneral.gov/opinions/greg-abbott/ga-0271
• Original PDF: https://www.texasattorneygeneral.gov/sites/default/files/opinion-files/opinion/2004/ga0271.pdf

Original opinion text

Best-effort transcription from a scanned PDF. Minor errors may remain, the linked PDF is authoritative.

ATTORNEY GENERAL OF TEXAS

GREG ABBOTT

November 17, 2004

The Honorable Wayne Smith
Chair, Committee on County Affairs
Texas House of Representatives
Post Office Box 2910
Austin, Texas 78768-2910

Opinion No. GA-0271

Re: Whether health care providers administering vaccinations in hospitals under the federal Medicare 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.[1]

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 influenza 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 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. § 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. § 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 "[t]he 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 staff who are in contact with elderly residents." TEX. HEALTH & SAFETY CODE ANN. § 161.0051(c) (Vernon 2001). Moreover, other statutes direct that "[h]ospitals shall be responsible for administering needed vaccinations" to children or "referring the child for immunization." Id. § 161.004(b)(3) (Vernon Supp. 2004-05). These provisions indicate that when it wishes to require immunizations for specific categories of persons, 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 of Boerne, 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.

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,

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

Footnotes

[1] 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 file with Opinion Committee, also available at www.oag.state.tx.us) [hereinafter Request Letter].