2011-3439. Federal Tort Claims Act (FTCA) Medical Malpractice Program Regulations: Clarification of FTCA Coverage for Services Provided to Non-Health Center Patients

AGENCY:

Health Resources and Services Administration, HHS.

ACTION:

Notice of proposed rulemaking.

SUMMARY:

The Federally Supported Health Centers Assistance Act of 1992, as amended in 1995 (FSHCAA), provides for liability protection for certain grantees of the Public Health Service and for certain individuals associated with these grantees. The Health Resources and Services Administration (HRSA) is the operating division within the Department responsible for administering certain aspects of FSHCAA. HRSA proposes replacing the current regulations with the key text and examples of activities that have been determined, consistent with provisions of the existing regulation, to be covered by the FTCA, as previously published in the Sept. 25, 1995 Federal Register. In addition, HRSA proposes adding an example of services covered under the FTCA involving individual emergency care provided to a non-health center patient and updating the September 1995 Notice immunization example to include events to immunize individuals against infectious illnesses. When finalized, the amended regulation will supersede the September 1995 Notice.

DATES:

Written comments must be received on or before April 29, 2011. Subject to consideration of the comments submitted, the Department intends to publish final regulations.

ADDRESSES:

You may submit comments, identified by the Regulatory Information Number (RIN) 0906-AA77, by any of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
• E-mail: [e-mail]. Include “RIN 0906-AA77” in the subject line of the message.
• Mail: Correspondence should be marked “Health Center FTCA Program Regulation Comments” and mailed to: Office of Quality and Data, Bureau of Primary Health Care, Health Resources and Services Administration, U.S. Department of Health and Human Services, 5600 Fishers Lane, Room 15C-26, Rockville, Maryland 20857.

Instructions: All submissions received must include the agency name and RIN for this rulemaking. All comments received will be available for public inspection and copying without charge at Parklawn Building, 5600 Fishers Lane, Room 15C-26, Rockville, Maryland 20857, weekdays (Federal holidays excepted) between the hours of 8:30 a.m. and 5 p.m.

FOR FURTHER INFORMATION CONTACT:

Suma Nair, Director, Office of Quality and Data, Bureau of Primary Health Care, Health Resources and Services Administration, U.S. Department of Health and Human Services, 5600 Fishers Lane, Room 15C-26, Rockville, Maryland 20857, Phone: [phone].

SUPPLEMENTARY INFORMATION:

Section 224(a) of the Public Health Service (PHS) Act (42 U.S.C. 233(a)) provides that the remedy against the United States provided under the Federal Tort Claims Act (FTCA) resulting from the performance of medical, surgical, dental or related functions by any commissioned officer or employee of the PHS while acting within the scope of his office or employment shall be exclusive of any other related civil action or proceeding. The Federally Supported Health Centers Assistance Act of 1992 (Pub. L. 102-501), as amended in 1995 (FSHCAA), provides that, subject to its provisions, certain entities receiving funds under section 330 of the PHS Act, as well as any officers, governing board members, and employees, and certain contractors of these entities, shall be deemed for the purposes of medical malpractice liability to be employees of the PHS within the exclusive remedy provision of section 224(a) of the PHS Act.

A final rule implementing Public Law 102-501 was published in the Federal Register (60 FR 22530) on May 8, 1995, and added a new part 6 to 42 CFR chapter 1, subchapter A. This rule describes the eligible entities and the covered individuals who are or may be determined by the Secretary to be within the scope of the FTCA protection afforded by the Act.

Section 6.6, also published in the May 8, 1995 rule, describes acts and omissions that are covered by FSHCAA (covered activities or covered services). Subsection 6.6(d) restates the statutory criteria that may support a determination of coverage for services provided to individuals who are not patients of the covered entity.

Subsection 6.6(e) provides examples of situations within the scope of subsection 6.6(d). Questions were raised, however, about the specific situations encompassed by 6.6(d) and 6.6(e) and about the process for the Secretary to make the determinations provided by those subsections.

HRSA decided that it would be impractical and burdensome to require a separate application and determination of coverage for certain situations described in the examples set forth in 6.6(e), as further discussed in the September 1995 Notice (60 FR 49417). For those situations, the Department has set forth its determination that coverage is provided under 42 CFR 6.6(d) without the need for a separate application, so long as other requirements for coverage are met, such as a determination that the entity is a covered entity, a determination that the individual is a covered individual, and that the acts or omissions by those individuals occur within the scope of employment.

HRSA proposes including the key text and examples of the September 1995 Notice in 42 CFR 6.6(e), replacing the current regulatory text at 42 CFR 6.6(e). HRSA also proposes updating the “Immunization Campaign” example to clarify that this covered situation includes events to immunize individuals against infectious illnesses and does not limit coverage to only childhood vaccinations. In addition, HRSA proposes adding the following additional new example as subsection 6.6(e)(4) to set forth its determination of FTCA coverage for services to non-health center patients in certain individual emergency situations. This addition is expected to provide assurance of FTCA coverage in these situations and encourage reciprocal assistance by non-health center clinicians for health center patients in similar emergencies.

We will consider comments on this proposed rule that are received within 60 days of publication of this notice in the Federal Register. After the comment period closes, we will publish a final rule in the Federal Register. The document will include a discussion of any comments we receive and any changes.

Federalism

HRSA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. HRSA has determined that the proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, HRSA has concluded that the proposed rule does not contain policies that have Federalism implications as defined in the Executive Order and, consequently, a Federalism summary impact statement is not required.

Other Impacts

HRSA has examined the impacts of the proposed rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). HRSA believes that this proposed rule is not a significant regulatory action under the Executive Order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this proposed rule simply updates an existing regulation to add further details to the description of certain situations that are covered by the FTCA, and because such coverage is provided for under Federal law, HRSA certifies that the rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” HRSA does not expect this proposed rule to result in any one-year expenditure that would meet or exceed this amount.

Paperwork Reduction Act

This rule does not contain any new information collection or recordkeeping requirements that fall under the purview of the Paperwork Reduction Act of 1995. The recordkeeping requirements contained in this rule are part of normal business practice and do not require the collection of new information or impose additional requirements beyond current routine practice.

List of Subjects in 42 CFR Part 6

• Emergency medical services
• Health care
• Health facilities
• Tort claims

Dated: May 27, 2010.

Mary Wakefield,

Administrator, Health Resources and Services Administration.

Approved: January 24, 2011.

Kathleen Sebelius,

Secretary.

For the reasons stated in the preamble, we are proposing to amend 42 CFR part 6 as follows:

PART 6—FEDERAL TORT CLAIMS ACT COVERAGE OF CERTAIN GRANTEES AND INDIVIDUALS

1. The authority citation for part 6 continues to read as follows:

Authority: Sections 215 and 224 of the Public Health Service Act, 42 U.S.C. 216 and 233.

2. In § 6.6, revise paragraph (e) to read as follows:

§ 6.6

Covered acts and omissions.

* * * * *

(e) For the specific activities described in this paragraph, when carried out by an entity that has been covered under paragraph (c) of this section, the Department has determined that coverage is provided under paragraph (d) of this section, without the need for specific application for a coverage determination under paragraph (d) of this section, if the activity or arrangement in question fits squarely within the examples of activities listed below; otherwise, the health center should seek a particularized determination of coverage under paragraph (d) of this section.

(1) Community-Wide Interventions. (i) School-Based Clinics. Health center staff provide primary and preventive health care services at a facility located in a school or on school grounds. The health center has a written affiliation agreement with the school.

(ii) School-Linked Clinics. Health center staff provide primary and preventive health care services, at a site not located on school grounds, to students of one or more schools. The health center has a written affiliation agreement with each school.

(iii) Health Fairs. Health center staff conduct an event to attract community members for purposes of performing health assessments. Such events may be held in the health center, outside on its grounds, or elsewhere in the community.

(iv) Immunization Campaigns. Health center staff conduct an event to immunize individuals against infectious illnesses. The event may be held at the health center, schools, or elsewhere in the community.

(v) Migrant Camp Outreach. Health center staff travel to a migrant farmworker residence camp to conduct intake screening to determine those in need of clinic services (which may mean health care is provided at the time of such intake activity or during subsequent clinic staff visits to the camp).

(vi) Homeless Outreach. Health center staff travel to a shelter for homeless persons, or a street location where homeless persons congregate, to conduct intake screening to determine those in need of clinic services (which may mean health care is provided at the time of such intake activity or during subsequent clinic staff visits to that location).

(2) Hospital-Related Activities. Periodic hospital call or hospital emergency room coverage is required by the hospital as a condition for obtaining hospital admitting privileges. There must also be documentation for the particular health care provider that this coverage is a condition of employment at the health center.

(3) Coverage-Related Activities. As part of a health center's arrangement with local community providers for after-hours coverage of its patients, the health center's providers are required by their employment contract to provide periodic or occasional cross-coverage for patients of these providers.

(4) Coverage in Certain Individual Emergencies. A health center provider is providing or undertaking to provide covered services to a health center patient within the approved scope of project of the center, or to an individual who is not a patient of the health center under the conditions set forth in this rule, when the provider is then asked, called upon, or undertakes, at or near that location and as the result of a non-health center patient's emergency situation, to temporarily treat or assist in treating that non-health center patient. In addition to any other documentation required for the original services, the health center must have documentation (such as employee manual provisions, health center bylaws, or an employee contract) that the provision of individual emergency treatment, when the practitioner is already providing or undertaking to provide covered services, is a condition of employment at the health center.