[Federal Register Volume 69, Number 135 (Thursday, July 15, 2004)]
[Notices]
[Pages 42445-42446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16037]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Notice Regarding Subsection 224(o) of the Public Health Service 
Act (Volunteer Services Provided by Health Professionals at Free 
Clinics)

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice whereby a person can determine when and the extent to 
which a volunteer health professional at a free clinic is deemed to be 
a Public Health Service employee.

-----------------------------------------------------------------------

SUMMARY: The Secretary of Health and Human Services (the ``Secretary'') 
provides the following notice regarding Section 224 of the Public 
Health Service Act (``the Act'') (42 U.S.C. 233), as amended by Public 
Law 104-191 (the Health Insurance Portability and Accountability Act of 
1996 (``HIPAA'')). Section 194 of HIPAA amended the Act by adding 
subsection 224(o), which provides for liability protection for certain 
free clinic health professionals. This notice sets forth information 
whereby a person can determine when and the extent to which a volunteer 
health professional at a free clinic is deemed to be a Public Health 
Service employee.

FOR FURTHER INFORMATION CONTACT: For further information, contact 
Program Director, Federal Tort Claims Act Medical Malpractice Program, 
Division of Clinical Quality, Bureau of Primary Health Care, Health 
Resources and Services Administration, 4530 East West Highway, 
Bethesda, MD 20857 (Phone: 301-594-0818 or E-mail: 
[email protected]).

SUPPLEMENTARY INFORMATION:

I. Introduction

    Section 224(a) of the Public Health Service (PHS) Act (42 U.S.C. 
233(a)) provides that the remedy against the United States 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 civil action or 
proceeding. Section 224(o) of the Act (added by Section 194 of the 
HIPPA) provides that under certain conditions, free clinic health care 
professionals shall be deemed to be employees of the PHS within the 
exclusive remedy provision of section 224(a). This notice is intended 
to provide information as to action that the Department of Health and 
Human Services (HHS) will take to implement the Act. Application 
instructions pertaining to the deeming process discussed below can be 
requested from the information contact listed above. Application 
instructions for free health clinic professionals to obtain PHS 
employment status for FTCA purposes (``FTCA deemed status'') are 
discussed below. Coverage under this program will be effective upon the 
receipt and approval of an application. Application forms and 
instructions may also be downloaded from HRSA's Bureau of Primary 
Health Care Web site at http://www.bphc.gov on or about September 1, 
2004. HRSA will process applications as received.

II. Definition of Free Clinics and Free Clinic Health Professionals

    Pursuant to the Act, HHS will provide free clinic health 
professionals with FTCA deemed status and FTCA coverage for medical 
malpractice claims only if it determines that the health care 
professional and the associated free clinic meet certain requirements.
    (A) Under the Act, a free clinic is a health care facility operated 
by a nonprofit private entity that:
    (1) In providing health care, does not accept reimbursement from 
any third-party payor (including reimbursement from any insurance 
policy, health plan, or Federal or State health benefits program);
    (2) In providing health care, does not impose charges on patients 
to whom service is provided OR imposes charges on patients according to 
their ability to pay*;
    (3) May accept patients' voluntary donations for health care 
service provision;
    (4) Is licensed or certified to provide health services in 
accordance with applicable law.
    (B) Under the Act, a free clinic health professional:
    (1) Provides services to patients at a free clinic or through 
offsite programs or events carried out by a free clinic;
    (2) Is sponsored by a free clinic (see section II(A) above);
    (3) Provides a qualifying health service (i.e., any health care 
service required or authorized to be provided under Title XIX of the 
Social Security Act (42 U.S.C 1396 et seq.) without regard to whether 
the service is included in the plan submitted by the State in which the 
health care practitioner provides the service;
    (4) Does not receive compensation for provided services from 
patients directly or from any third-party payor;

[[Page 42446]]

    (5) May receive repayment from a free clinic for reasonable 
expenses incurred in service provision to patients;
    (6) Is licensed or certified to provide health care services at the 
time of service provision in accordance with applicable law; and
    (7) Provides patients with written notification before service 
provision of the extent to which his/her legal liability is limited 
pursuant to the Act if his/her associated free clinic has not already 
provided such notification. In the case of an emergency, the written 
notice shall be provided as soon thereafter as is practicable. If the 
patient is a minor or is otherwise legally incompetent, the written 
notice shall be provided to a legal guardian or other person with legal 
responsibility for the care of the patient.

    *Free clinic entities may impose charges based on a patient's 
ability to pay, but in so doing negate the FTCA coverage of the 
volunteers for the specific services for which the clinic received 
payment.

III. FTCA Deeming Application

    A free clinic may sponsor a free clinic health professional for 
FTCA deemed status and FTCA coverage for medical malpractice claims by 
submitting an application meeting the requirements of subsection 
224(g)(1)(D) of the Act to the Secretary on behalf of the free clinic 
health professional. The application must be submitted in such form and 
manner as the Secretary shall prescribe. Moreover, the application must 
provide evidence that the free clinic:
    (A) Has implemented appropriate policies and procedures to reduce 
the risk of medical malpractice and lawsuits arising out of any health 
or health related functions performed by the free clinic;
    (B) Has reviewed and verified the credentials, references, claims 
history, fitness, professional review organization findings, and 
license status of its physicians and other licensed or certified health 
care practitioners, and, where necessary, has obtained its 
practitioners' permission to access this information;
    (C) Has no history of a patient filing a medical malpractice claim 
against the U.S. Government pursuant to Section 224 for services 
provided by its free clinic health professionals OR has fully 
cooperated with the Attorney General in his/her preparation of a 
defense against any such medical malpractice claim against the U. S. 
Government. If the free clinic has a history of such a claim, it also 
must demonstrate that it has taken or will take any necessary steps to 
prevent such medical malpractice claims in the future; and
    (D) Has pledged to fully cooperate with the Attorney General in 
providing information relating to an estimate of the number of expected 
medical malpractice claims for the following year as described in 
Section 224 of the Act.
    Pursuant to subsection 224(g)(1)(E) of the Act, the Secretary will 
determine if the free clinic health professional meets the requirements 
for FTCA deemed status of the free clinic health professional. The 
Secretary will provide the free clinic with a notice of the effective 
date of the free clinic health professional's FTCA deemed status. A 
free clinic health professional's deemed status shall apply only to 
acts or omissions within the scope of the professional's duties at the 
free clinic occurring on or after the effective date specified in the 
notice.
    This notice is not intended to constitute, and does not constitute, 
a comprehensive notice pertaining to any provision of the Act except to 
the extent that procedures pertaining to the implementation of the Act 
are described explicitly above.

    Dated: July 8, 2004.
Elizabeth M. Duke,
Administrator.
[FR Doc. 04-16037 Filed 7-14-04; 8:45 am]
BILLING CODE 4165-15-P