63926 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations

concurrence of the EPA with respect to

those provisions of the proposed

program amendment that relate to air or

water quality standards promulgated

under the authority of the Clean Water

Act (33 U.S.C. 1251 et seq.) or the Clean

Air Act (42 U.S.C. 7401 et seq,).

However, none of the revisions that

Texas proposed to make in this

amendment pertain to air or water

quality standards. Therefore, OSM did

not request EPA’s concurrence.

Pursuant to 732.17(h)(11)(i), OSM

solicited comment on the proposed

amendment from EPA (Administrative

Record No. TX–593.01). EPA did not

respond to OSM’s request.

State Historical Preservation Officer

(SHPO) and the Advisory Council on

Historic Preservation (ACHP)

Pursuant to 30 CFR 732.17(h)(4), OSM

is required to solicit comments on

proposed amendments which may have

an effect on historic properties from the

SHPO and ACHP. OSM solicited

comments on the proposed amendment

from the SHPO and ACHP

(Administrative Record No. TX–593.01).

Neither SHPO nor ACHP responded to

OSM’s request.

V. Director’s Decision

Based on the above findings, the

Director approves the proposed

amendment as submitted by Texas on

August 11, 1995, and as revised on

September 25, 1995, concerning selfbonding alternative financial

requirements for a business and

governmental entities.

The Director approves the rules as

proposed by Texas with the provision

that they be fully promulgated in

identical form to the rules submitted to

and reviewed by OSM and the public.

The Federal regulations at 30 CFR

943, codifying decisions concerning the

Texas program, are being amended to

implement this decision. This final rule

is being made effective immediately to

expedite the State program amendment

process and to encourage States to bring

their programs into conformity with the

Federal standards without undue delay.

Consistency of State and Federal

standards is required by SMCRA.

VI. Procedural Determinations

Executive Order 12866

This rule is exempted from review by

the Office of Management and Budget

(OMB) under Executive Order 12866

(Regulatory Planning and Review).

Executive Order 12778

The Department of the Interior has

conducted the reviews required by

section 2 of Executive Order 12778

(Civil Justice Reform) and has

determined that, to the extent allowed

by law, this rule meets the applicable

standards of subsections (a) and (b) of

that section. However, these standards

are not applicable to the actual language

of State regulatory programs and

program amendments since each such

program is drafted and promulgated by

a specific State, not by OSM. Under

sections 503 and 505 of SMCRA (30

U.S.C. 1253 and 1255) and the Federal

regulations at 30 CFR 730.11, 732.15,

and 732.17(h)(10), decisions on

proposed State regulatory programs and

program amendments submitted by the

States must be based solely on a

determination of whether the submittal

is consistent with SMCRA and its

implementing Federal regulations and

whether the other requirements of 30

CFR Parts 730, 731, and 732 have been

met.

National Environmental Policy Act

No environmental impact statement is

required for this rule since section

702(d) of SMCRA (30 U.S.C. 1292(d))

provides that agency decisions on

proposed State regulatory program

provisions do not constitute major

Federal actions within the meaning of

section 102(2)(C) of the National

Environmental Policy Act (42 U.S.C.

4332(2)(C)).

Paperwork Reduction Act

This rule does not contain

information collection requirements that

require approval by OMB under the

Paperwork Reduction Act (44 U.S.C.

3507 et seq.).

Regulatory Flexibility Act

The Department of the Interior has

determined that this rule will not have

a significant economic impact on a

substantial number of small entities

under the Regulatory Flexibility Act (5

U.S.C. 601 et seq.). The State submittal

which is the subject of this rule is based

upon corresponding Federal regulations

for which an economic analysis was

prepared and certification made that

such regulations would not have a

significant economic effect upon a

substantial number of small entities.

Accordingly, this rule will ensure that

existing requirements previously

promulgated by OSM will be

implemented by the State. In making the

determination as to whether this rule

would have a significant economic

impact, the Department relied upon the

data and assumptions for the

corresponding Federal regulations.

List of Subjects in 30 CFR Part 943

Intergovernmental relations, Surface

mining, Underground mining.

Dated: February 1, 1995.

Brent Wahlquist,

Regional Director, Mid-Continent Regional

Coordinating Center.

For the reasons set out in the

preamble, Title 30, Chapter VII,

Subchapter T of the Code of Federal

Regulations is amended as set forth

below:

PART 943—TEXAS

1. The authority citation for Part 943

continues to read as follows:

Authority: 30 U.S.C. 1201 et seq.

2. Section 943.15 is amended by

adding paragraph (1) to read as follows:

§ 943.15 Approval of regulatory program

amendments.

* * * * *

(1) The revisions to the following

regulations at 16 Texas Administrative

Code 11.221, the Coal Mining

Regulations of the Railroad Commission

of Texas, as submitted to OSM on

August 11, 1995, and as revised on

September 25, 1995, are approved

effective December 13, 1995.

TCMR 806.309(j)(2)(C)(iv)

(I)(A), (B), and (C).

Self-bonding:

financial requirements

for a business and

governmental

entities, Alternative Financial Eligibility Criteria

Test I.

TCMR 806.309(j)(2)(C)(iv)

(II)(A), (B), and (C).

Self-bonding:

financial requirements

for a business and

governmental

entities, Alternative Financial Eligibility Criteria

Test II.

[FR Doc. 95–30330 Filed 12–12–95; 8:45 am]

BILLING CODE 4310–05–M

DEPARTMENT OF VETERANS

AFFAIRS

38 CFR Part 1

RIN 2900–AE28

Confidentiality of Certain Medical

Records

AGENCY: Department of Veterans Affairs.
Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations 63927

ACTION: Final rule.

SUMMARY: This document establishes

Department of Veterans Affairs (VA)

regulations to implement specific

provisions of the Veterans Omnibus

Health Care Act of 1976 and the

Veterans’ Benefits and Services Act of

1988 concerning the confidentiality of

certain medical records. These

regulations protect the confidentiality of

VA records pertaining to drug abuse,

alcoholism or alcohol abuse, infection

with the human immunodeficiency

virus (HIV), and sickle cell anemia.

EFFECTIVE DATE: January 12, 1996.

FOR FURTHER INFORMATION CONTACT:

Celia Winter, Program Specialist,

Veterans Health Administration (161F),

Department of Veterans Affairs, 810

Vermont Avenue, NW, Washington, DC

20420, (202) 273–6274.

SUPPLEMENTARY INFORMATION: On July

26, 1993, at 58 FR 39703, VA published

a notice of proposed rulemaking

(NPRM) concerning the confidentiality

of VA records pertaining to drug abuse,

alcoholism or alcohol abuse, infection

with the human immunodeficiency

virus (HIV) and sickle cell anemia

treatment, rehabilitation, education,

training, evaluation and research

information. Interested parties were

invited to submit written comments on

or before August 25, 1993. Two

comments were received.

Background

VA was mandated by the Veterans

Omnibus Health Care Act of 1976 and

the Veterans’ Benefits and Services Act

of 1988 to publish its own regulations

relative to the confidentiality of medical

records relating to drug abuse,

alcoholism or alcohol abuse, infection

with the HIV, and sickle cell anemia.

VA, generally, has been following the

Department of Health and Human

Services’ regulations on drug and

alcohol abuse which were published in

the Federal Register, July 1, 1975. The

Department of Health and Human

Services (HHS) regulations (42 CFR

§§ 2.1–2.67) were promulgated with the

enactment of legislation specific to

alcohol and drug abuse programs and

confidentiality of records. The

regulations take into consideration the

existing HHS regulations in

implementing the confidentiality

section of the Veterans Omnibus Health

Care Act of 1976. Editorial and

substantive changes were made to the

HHS regulations which were published

in the Federal Register, June 9, 1987.

The historical development of the

regulations begins with Pub. L. 93–282,

‘‘Comprehensive Alcohol Abuse and

Alcoholism Prevention, Treatment, and

Rehabilitation Act Amendments of

1974,’’ which provided that the then

Administrator of Veterans Affairs,

through the then Chief Medical Director,

consistent with responsibilities under

Title 38, United States Code, prescribe

regulations applicable to the

confidentiality of medical records

maintained in connection with the

provision of hospital care, nursing home

care, domiciliary care and medical

services under Title 38 to patients

suffering from alcohol abuse,

alcoholism, and drug abuse. In

prescribing and implementing these

regulations, the Secretary of Veterans

Affairs was required to consult with the

Secretary of HHS in order to achieve the

maximum possible coordination of the

regulations.

Congress, recognizing that the

particular problems of confidentiality of

records in the VA health care system

would best be handled by placing

applicable provisions in Title 38, United

States Code, added a new § 4132, now

§ 7332, to Title 38, United States Code,

with the enactment of Pub. L. 94–581,

Veterans Omnibus Health Care Act of

1976. The intent of this legislation was

to ensure confidentiality of certain

medical records by establishing

sanctions for unauthorized disclosure of

information, while at the same time,

meeting the legitimate needs for

disclosure under certain conditions. As

part of this legislation, Congress

imposed upon VA requirements similar

to those of Pub. L. 93–282 noted above

(38 U.S.C. § 7334, formerly § 4134).

Section 111 of Pub. L. 94–581

replaced, for VA purposes, the

provisions of Sections 122(a) and 303 of

Pub. L. 93–282 (21 U.S.C.§ 1175, for

drug records; 42 U.S.C. § 4582, for

alcohol records) as the statutory base for

confidentiality of drug and alcohol

abuse records for those patients treated

by VA medical facilities. Additionally,

it replaced Section 109 of Pub. L. 93–

82 (38 U.S.C. § 1753(b), formerly

§ 653(b)) which provided for

confidentiality of sickle cell anemia

records and required VA to promulgate

regulations. Pub. L. 94–581, Veterans

Omnibus Health Care Act of 1976,

addressed all three subjects—drug

abuse, alcoholism and sickle cell

anemia records—in its confidentiality

mandate. Section 121 of Pub. L. 100–

322 provided for the confidentiality of

records relating to infection with the

HIV. Accordingly, drug and alcohol

abuse, infection with the HIV, and

sickle cell anemia records are included

in these regulations.

VA has followed regulations on the

confidentiality of patients’ records

related to drug and alcohol abuse as

prescribed in 1975 by the Secretary of

HHS. Certain provisions of the HHS

regulations are inconsistent with VA

requirements and these new VA

regulations address those

inconsistencies. Staff at HHS reviewed a

draft of the regulations prior to

publication and changes were made

based on the comments where there was

statutory authority for the change.

The HHS regulations as revised in

1987 and further amended on May 5,

1995, cover only alcohol and drug abuse

information that is obtained by a

specialized program or specific provider

whose primary function is the provision

of alcohol or drug abuse diagnosis,

treatment, or referral for treatment. The

1987 regulations do not cover alcohol

and drug abuse information obtained by

health care facilities which provide

alcohol and drug abuse care only as an

incident to the provision of general

medical care. The VA regulations

include all records which are

maintained in connection with the

performance of any VA program or

activity (including education, training,

evaluation, treatment, rehabilitation or

research) relating to drug abuse,

alcoholism, infection with the HIV, or

sickle cell anemia in order to provide

greater confidentiality for patients who

are provided care for these conditions.

On May 5, 1995, HHS published a final

rule in 60 FR 22296, amending its

confidentiality regulations with regard

to the definition of ‘‘program.’’ HHS’s

final rule was in direct response to the

holding made by the Ninth Circuit in a

case involving the VA, United States v.

Eide, 875 F.2d 1429, 1438 (9th Cir.

1989). There the court held the VAMC’s

(VA medical center) general emergency

room to be a ‘‘program’’ as defined by

the HHS regulations, upon which VA’s

policy is based. In its final rule, HHS

limited the definition of ‘‘program’’ to:

(1) an individual or entity, or an

identified unit within a medical care

facility, who holds itself out as

providing, and provides, alcohol or drug

abuse diagnosis, treatment or referral for

treatment, or (2) medical personnel or

other staff in a general medical care

facility, whose primary function is the

provision of alcohol or drug abuse

diagnosis, treatment or referral for

treatment and who are identified as

such providers. VA’s final regulations

DO NOT reflect the same regulatory

language concerning the definition of a

‘‘program’’ as the HHS regulations due

to the VA’s treatment of the

encompassed conditions as an integral

part of the VA medical health care

system and not a separate program
63928 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations

isolated from other Department

functions. VA believes, as does HHS,

that clarification of this point is

necessary to help prevent other courts

from ruling as the Ninth Circuit did in

Eide, even as to the VA version of these

regulations. Therefore, a specific

example has been added to § 1.460(k)(2)

to reflect that one-time emergency room

care, where neither treatment or referral

for treatment of the underlying drug or

alcohol abuse condition is offered or

sought, does not fall within the purview

of these regulations. It was determined

that a specific example was necessary to

distinguish between those instances

where an individual is brought into an

emergency room for a potential drug

overdose, receives one-time treatment

and is released, from those instances

where an individual enters an

emergency room with, or acquires while

there, the purpose of seeking treatment

for his or her drug addiction, or VA

offers treatment for such condition.

Discussion of Comments

A total of two comments were

received—one from a national medical

specialty society and the other from a

not-for-profit public interest law firm

that specializes in legal and policy

issues related to substance abuse and

HIV/AIDS. One of the commenters

suggested that the regulations be revised

to include a requirement that patients be

given written notice and summary of the

confidentiality protections of the subject

records by §§ 1.460 through 1.499. This

provision is included in the HHS

regulations at 42 CFR 2.22. The HHS

regulations provide confidentiality

protections for drug or alcohol abuse

information that is obtained by a

specialized program or specific provider

whose primary function is the provision

of alcohol or drug abuse diagnosis,

treatment, or referral for treatment.

Consequently, the patients are easily

identified at the initiation of treatment

and can be provided the written notice

and summary. The VA regulations,

however, provide for the confidentiality

of all records which are maintained in

connection with the performance of any

VA program or activity. Consequently,

medical care may be given for drug or

alcohol abuse, sickle cell anemia, or

infection with the HIV in conjunction

with, and after the initiation of medical

care for other conditions. These patients

are not as readily recognized as an

individual who should be provided

with the written notice and summary of

the confidentiality protections. While

VA will take efforts to notify patients of

these provisions through notices in

patient information handouts,

handbooks, etc., it would not be

possible to positively assure every

patient will receive the notification as

would be required if provided for in the

regulations. Thus, we have not adopted

this suggestion.

The same commenter suggested the

addition of a provision that would

provide for limitations on court-ordered

disclosure of confidential

communications. They suggested that

disclosure of confidential

communications that a patient provides

to a treatment service be limited to those

situations where a serious crime is

reported or threatened, or where the

patient has already testified about

confidential communications in a

formal proceeding, such as is provided

for by HHS at 42 CFR 2.63. The final

regulations have been revised to include

the suggested provision. This is

consistent with 38 U.S.C. 7334 which

requires that the VA regulations follow

the HHS regulations as far as possible.

Accordingly, it has been added at

§ 1.491. The provisions previously

published at § 1.491 and following have

been renumbered following the newly

inserted provision.

Another commenter addressed

§ 1.489(c) which provides for the release

of identifiable patient records to

‘‘congressional committees or

subcommittees for program oversight

and evaluation if such records pertain to

any matter within the jurisdiction of

such committee or subcommittee.’’ The

commenter did not understand the

necessity for a broad based

authorization for the release of

individually identifiable patient records

for program oversight and evaluation

and assumed that Congressional

committees would not have a need for

individual records, but rather a

compilation of information without

patient identifiers. It was further stated

that the standards of disclosure to

Congress of individually identifiable

patient records for these diagnoses

should be the same as for other Federal

and State entities. We do not agree with

this suggestion. As part of their

oversight responsibilities, Congressional

committees do review individual

patient treatment issues as well as

overall program issues. In order to carry

out this function, they need access to

treatment information concerning

directly affected individuals. These

responsibilities are not shared nor are

they the responsibility of other Federal

and State entities. For these reasons, the

provision was not revised.

The same commenter recommended a

revision of section 1.487 which provides

for the notification of information

related to infection with the human

immunodeficiency virus to the spouse

or sexual partner of a patient. Disclosure

may be made only after the patient’s

physician or counselor, after making

reasonable efforts to counsel and

encourage the patient to provide the

information to the spouse or sexual

partner, reasonably believes that the

patient will not provide the information

and that the disclosure is necessary to

protect the health of the spouse or

sexual partner. The commenter

recommended that the provision be

refined to include a focus on risk

behavior modification. No changes were

made based on the comment. The

regulation addresses the issue of

confidentiality and the disclosure,

under certain conditions, of the

information to individuals who are at

risk. The issue of risk behavior

modification is best addressed in

treatment and therapeutic publications,

policies, guidelines, etc.

These regulations are not intended to

direct the manner in which substantive

functions, such as research, treatment,

and evaluation should be carried out,

but rather to define the minimum

requirements for the protection of

confidentiality of patient records which

must be satisfied in connection with the

conduct of those functions in order to

carry out the purposes of the

authorizing legislation.

An additional, clarifying change to

the regulations has been made

concerning internal non-patient

investigations and healthcare

inspections conducted by the Office of

Inspector General (OIG). During the

internal review process, a question was

raised by the VA’s OIG as to whether

OIG would be prohibited access to

records protected by the regulations in

cases involving healthcare inspections

or criminal investigations of nonpatients. Because the statute prohibits

access to such records only where the

patient is the subject of an investigation,

and because the OIG would have a need

for the information in connection with

their duties, we have included language

in § 1.461(c) that explicitly extends the

exception of coverage of the regulations

to healthcare inspections and nonpatient investigations conducted by

OIG. We have also added language

clarifying that confidential information

obtained by VA components, including

OIG, who have a need for the

information in connection with their

duties, may not be redisclosed except in

accordance with the regulations. These

clarifications from the proposed rule

merely reflect our interpretation of

statutory authority.

Other nonsubstantive changes have

been added for purposes of clarity.
Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations 63929

Executive Order 12866

This regulatory action has been

reviewed by the Office of Management

and Budget under Executive Order

12866.

Regulatory Flexibility Act

The Secretary hereby certifies that

this final rule will not have a significant

economic impact on a substantial

number of small entities as they are

defined in the Regulatory Flexibility

Act, 5 U.S.C. 600–612. This rule will

affect VA beneficiaries and will not

affect small businesses. Therefore,

pursuant to 5 U.S.C. 605(b), this final

rule is exempt from the initial and final

regulatory flexibility analyses

requirements of §§ 603 and 604.

The Paperwork Reduction Act

Section 1.475 of this regulation

contains an information collection

requirement that has been approved by

the Office of Management and Budget

(OMB) in accordance with the

requirements of the Paperwork

Reduction Act and has been assigned

OMB Control No. 2900–0544 (expiration

date is October 31, 1996). The

Department of Veterans Affairs

estimates that it will take an average of

five minutes per respondent to provide

the required information for the consent

form and there will be approximately

20,640 such requests made per year.

List of Subjects in 38 CFR Part 1

Administrative procedures, Privacy

Act, Recordkeeping.

Approved: August 24, 1995.

Jesse Brown,

Secretary of Veterans Affairs.

In consideration of the foregoing, the

Department of Veterans Affairs amends

38 CFR part 1, General Provisions, as

follows:

PART 1—GENERAL

1. The authority citation for part 1 is

revised to read as follows:

Authority: 38 U.S.C. 501(a), unless

otherwise noted.

2. Sections 1.460 through 1.499, an

undesignated center heading, note, and

authority citation preceding § 1.460, and

undesignated center headings preceding

§§ 1,475, 1,475 and 1,485 and 1,490 are

added to read as follows:

Release of Information from

Department of Veterans Affairs (VA)

Records Relating to Drug Abuse,

Alcoholism or Alcohol Abuse, Infection

with the Human Immunodeficiency

Virus (HIV), or Sickle Cell Anemia

Sec.

1.460 Definitions.

1.461 Applicability.

1.462 Confidentiality restrictions.

1.463 Criminal penalty for violations.

1.464 Minor patients.

1.465 Incompetent and deceased patients.

1.466 Security for records.

1.467 Restrictions on the use of

identification cards and public signs.

1.468 Relationship to Federal statutes

protecting research subjects against

compulsory disclosure of their identity.

1.469 Patient access and restrictions on use.

1.470–1.474 [Reserved]

Disclosures With Patient’s Consent

1.475 Form of written consent.

1.476 Prohibition on redisclosure.

1.477 Disclosures permitted with written

consent.

1.478 Disclosures to prevent multiple

enrollments in detoxification and

maintenance treatment programs; not

applicable to records relating to sickle

cell anemia or infection with the human

immunodeficiency virus.

1.479 Disclosures to elements of the

criminal justice system which have

referred patients.

1.480–1.484 [Reserved]

Disclosures Without Patient Consent

1.485 Medical emergencies.

1.486 Disclosure of information related to

infection with the human

immunodeficiency virus to public health

authorities.

1.487 Disclosure of information related to

infection with the human

immunodeficiency virus to the spouse or

sexual partner of the patient.

1.488 Research activities.

1.489 Audit and evaluation activities.

Court Orders Authorizing Disclosures and

Use

1.490 Legal effect of order.

1.491 Confidential communications.

1.492 Order not applicable to records

disclosed without consent to researchers,

auditors and evaluators.

1.493 Procedures and criteria for orders

authorizing disclosures for noncriminal

purposes.

1.494 Procedures and criteria for orders

authorizing disclosure and use of records

to criminally investigate or prosecute

patients.

1.495 Procedures and criteria for orders

authorizing disclosure and use of records

to investigate or prosecute VA or

employees of VA.

1.496 Orders authorizing the use of

undercover agents and informants to

criminally investigate employees or

agents of VA.

1.497–1.499 [Reserved]

Release of Information From

Department of Veterans Affairs Records

Relating to Drug Abuse, Alcoholism or

Alcohol Abuse, Infection With the

Human Immunodeficiency Virus (HIV),

or Sickle Cell Anemia

Note: Sections 1.460 through 1.499 of this

part concern the confidentiality of

information relating to drug abuse,

alcoholism or alcohol abuse, infection with

the human immunodeficiency virus, or sickle

cell anemia in VA records and are applicable

in combination with other regulations

pertaining to the release of information from

VA records. Sections 1.500 through 1.527,

Title 38, Code of Federal Regulations,

implement the provisions of 38 U.S.C.

§§ 5701 and 5702. Sections 1.550 through

1.559 implement the provisions of 5 U.S.C.

§ 552 (The Freedom of Information Act).

Sections 1.575 through 1.584 implement the

provisions of 5 U.S.C. § 552a (The Privacy

Act of 1974).

The provisions of §§ 1.460 through 1.499 of

this part pertain to any program or activity,

including education, treatment, rehabilitation

or research, which relates to drug abuse,

alcoholism or alcohol abuse, infection with

the human immunodeficiency virus, or sickle

cell anemia. The statutory authority for the

drug abuse provisions and alcoholism or

alcohol abuse provisions of §§ 1.460 through

1.499 is Sec. 111 of Pub. L. 94–581, the

Veterans Omnibus Health Care Act of 1976

(38 U.S.C. §§ 7331 through 7334), the

authority for the human immunodeficiency

virus provisions is Sec. 121 of Pub. L. 100–

322, the Veterans’ Benefits and Services Act

of 1988 (38 U.S.C. § 7332); the authority for

the sickle cell anemia provisions is Sec. 109

of Pub. L. 93–82, the Veterans Health Care

Expansion Act of 1973 (38 U.S.C. §§ 1751–

1754).

Authority: 38 USC 1751–1754 and 7331–

7334.

§ 1.460 Definitions.

For purposes of §§ 1.460 through

1.499 of this part, the following

definitions apply:

Alcohol abuse. The term ‘‘alcohol

abuse’’ means the use of an alcoholic

beverage which impairs the physical,

mental, emotional, or social well-being

of the user.

Contractor. The term ‘‘contractor’’

means a person who provides services

to VA such as data processing, dosage

preparation, laboratory analyses or

medical or other professional services.

Each contractor shall be required to

enter into a written agreement

subjecting such contractor to the

provisions of §§ 1.460 through 1.499 of

this part; 38 U.S.C. 5701 and 7332; and

5 U.S.C. 552a and 38 CFR 1.576(g).

Diagnosis. The term ‘‘diagnosis’’

means any reference to an individual’s

alcohol or drug abuse or to a condition

which is identified as having been

caused by that abuse or any reference to

sickle cell anemia or infection with the

human immunodeficiency virus which

is made for the purpose of treatment or
63930 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations

referral for treatment. A diagnosis

prepared for the purpose of treatment or

referral for treatment but which is not so

used is covered by §§ 1.460 through

1.499 of this part. These regulations do

not apply to a diagnosis of drug

overdose or alcohol intoxication which

clearly shows that the individual

involved is not an alcohol or drug

abuser (e.g., involuntary ingestion of

alcohol or drugs or reaction to a

prescribed dosage of one or more drugs).

Disclose or disclosure. The term

‘‘disclose’’ or ‘‘disclosure’’ means a

communication of patient identifying

information, the affirmative verification

of another person’s communication of

patient identifying information, or the

communication of any information from

the record of a patient who has been

identified.

Drug abuse. The term ‘‘drug abuse’’

means the use of a psychoactive

substance for other than medicinal

purposes which impairs the physical,

mental, emotional, or social well-being

of the user.

Infection with the human

immunodeficiency virus (HIV). The term

‘‘infection with the human

immunodeficiency virus (HIV)’’ means

the presence of laboratory evidence for

human immunodeficiency virus

infection. For the purposes of §§ 1.460

through 1.499 of this part, the term

includes the testing of an individual for

the presence of the virus or antibodies

to the virus and information related to

such testing (including tests with

negative results).

Informant. The term ‘‘informant’’

means an individual who is a patient or

employee or who becomes a patient or

employee at the request of a law

enforcement agency or official and who

at the request of a law enforcement

agency or official observes one or more

patients or employees for the purpose of

reporting the information obtained to

the law enforcement agency or official.

Patient. The term ‘‘patient’’ means

any individual or subject who has

applied for or been given a diagnosis or

treatment for drug abuse, alcoholism or

alcohol abuse, infection with the human

immunodeficiency virus, or sickle cell

anemia and includes any individual

who, after arrest on a criminal charge,

is interviewed and/or tested in

connection with drug abuse, alcoholism

or alcohol abuse, infection with the

human immunodeficiency virus, or

sickle cell anemia in order to determine

that individual’s eligibility to

participate in a treatment or

rehabilitation program. The term patient

includes an individual who has been

diagnosed or treated for alcoholism,

drug abuse, HIV infection, or sickle cell

anemia for purposes of participation in

a VA program or activity relating to

those four conditions, including a

program or activity consisting of

treatment, rehabilitation, education,

training, evaluation, or research. The

term ‘‘patient’’ for the purpose of

infection with the human

immunodeficiency virus or sickle cell

anemia, includes one tested for the

disease.

Patient identifying information. The

term ‘‘patient identifying information’’

means the name, address, social security

number, fingerprints, photograph, or

similar information by which the

identity of a patient can be determined

with reasonable accuracy and speed

either directly or by reference to other

publicly available information. The term

does not include a number assigned to

a patient by a treatment program, if that

number does not consist of, or contain

numbers (such as social security, or

driver’s license number) which could be

used to identify a patient with

reasonable accuracy and speed from

sources external to the treatment

program.

Person. The term ‘‘person’’ means an

individual, partnership, corporation,

Federal, State or local government

agency, or any other legal entity.

Records. The term ‘‘records’’ means

any information received, obtained or

maintained, whether recorded or not, by

an employee or contractor of VA, for the

purpose of seeking or performing VA

program or activity functions relating to

drug abuse, alcoholism, tests for or

infection with the human

immunodeficiency virus, or sickle cell

anemia regarding an identifiable patient.

A program or activity function relating

to drug abuse, alcoholism, infection

with the human immunodeficiency

virus, or sickle cell anemia includes

evaluation, treatment, education,

training, rehabilitation, research, or

referral for one of these conditions.

Sections 1.460 through 1.499 of this part

apply to a primary or other diagnosis, or

other information which identifies, or

could reasonably be expected to

identify, a patient as having a drug or

alcohol abuse condition, infection with

the human immunodeficiency virus, or

sickle cell anemia (e.g., alcoholic

psychosis, drug dependence), but only if

such diagnosis or information is

received, obtained or maintained for the

purpose of seeking or performing one of

the above program or activity functions.

Sections 1.460 through 1.499 of this part

do not apply if such diagnosis or other

information is not received, obtained or

maintained for the purpose of seeking or

performing a function or activity

relating to drug abuse, alcoholism,

infection with the human

immunodeficiency virus, or sickle cell

anemia for the patient in question.

Whenever such diagnosis or other

information, not originally received or

obtained for the purpose of obtaining or

providing one of the above program or

activity functions, is subsequently used

in connection with such program or

activity functions, those original entries

become a ‘‘record’’ and §§ 1.460 through

1.499 of this part thereafter apply to

those entries. Segregability: these

regulations do not apply to records or

information contained therein, the

disclosure of which (the circumstances

surrounding the disclosure having been

considered) could not reasonably be

expected to disclose the fact that a

patient has been connected with a VA

program or activity function relating to

drug abuse, alcoholism, infection with

the human immunodeficiency virus, or

sickle cell anemia.

(1) The following are examples of

instances whereby records or

information related to alcoholism or

drug abuse are covered by the

provisions of §§ 1.460 through 1.499 of

this part:

(i) A patient with alcoholic delirium

tremens is admitted for detoxification.

The patient is offered treatment in a VA

alcohol rehabilitation program which he

declines.

(ii) A patient who is diagnosed as a

drug abuser applies for and is provided

VA drug rehabilitation treatment.

(iii) While undergoing treatment for

an unrelated medical condition, a

patient discusses with the physician his

use and abuse of alcohol. The physician

offers VA alcohol rehabilitation

treatment which is declined by the

patient.

(2) The following are examples of

instances whereby records or

information related to alcoholism or

drug abuse are not covered by the

provisions of §§ 1.460 through 1.499 of

this part:

(i) A patient with alcoholic delirium

tremens is admitted for detoxification,

treated and released with no counseling

or treatment for the underlying

condition of alcoholism.

(ii) While undergoing treatment for an

unrelated medical condition, a patient

informs the physician of a history of

drug abuse fifteen years earlier with no

ingestion of drugs since. The history

and diagnosis of drug abuse is

documented in the hospital summary

and no treatment is sought by the

patient or offered or provided by VA

during the current period of treatment.

(iii) While undergoing treatment for

injuries sustained in an accident, a

patient’s medical record is documented
Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations 63931

to support the judgment of the

physician to prescribe certain alternate

medications in order to avoid possible

drug interactions in view of the patient’s

enrollment and treatment in a non-VA

methadone maintenance program. The

patient states that continued treatment

and follow-up will be obtained from

private physicians and VA treatment for

the drug abuse is not sought by the

patient nor provided or offered by the

staff.

(iv) A patient is admitted to the

emergency room suffering from a

possible drug overdose. The patient is

treated and released; a history and

diagnosis of drug abuse may be

documented in the hospital summary.

The patient is not offered treatment for

the underlying conditions of drug abuse,

nor is treatment sought by the patient

for that condition.

Third party payer. The term ‘‘third

party payer’’ means a person who pays,

or agrees to pay, for diagnosis or

treatment furnished to a patient on the

basis of a contractual relationship with

the patient or a member of his or her

family or on the basis of the patient’s

eligibility for Federal, State, or local

governmental benefits.

Treatment. The term ‘‘treatment’’

means the management and care of a

patient for drug abuse, alcoholism or

alcohol abuse, infection with the human

immunodeficiency virus, or sickle cell

anemia, or a condition which is

identified as having been caused by one

or more of these conditions, in order to

reduce or eliminate the adverse effects

upon the patient. The term includes

testing for the human

immunodeficiency virus or sickle cell

anemia.

Undercover agent. The term

‘‘undercover agent’’ means an officer of

any Federal, State, or local law

enforcement agency who becomes a

patient or employee for the purpose of

investigating a suspected violation of

law or who pursues that purpose after

becoming a patient or becoming

employed for other purposes.

(Authority: 38 U.S.C. 7334)

§ 1.461 Applicability.

(a) General.

(1) Restrictions on disclosure. The

restrictions on disclosure in these

regulations apply to any information

whether or not recorded, which:

(i) Would identify a patient as an

alcohol or drug abuser, an individual

tested for or infected with the human

immunodeficiency virus (HIV), hereafter

referred to as HIV, or an individual with

sickle cell anemia, either directly, by

reference to other publicly available

information, or through verification of

such an identification by another

person; and

(ii) Is provided or obtained for the

purpose of treating alcohol or drug

abuse, infection with the HIV, or sickle

cell anemia, making a diagnosis for that

treatment, or making a referral for that

treatment as well as for education,

training, evaluation, rehabilitation and

research program or activity purposes.

(2) Restriction on use. The restriction

on use of information to initiate or

substantiate any criminal charges

against a patient or to conduct any

criminal investigation of a patient

applies to any information, whether or

not recorded, which is maintained for

the purpose of treating drug abuse,

alcoholism or alcohol abuse, infection

with the HIV, or sickle cell anemia,

making a diagnosis for that treatment, or

making a referral for that treatment as

well as for education, training,

evaluation, rehabilitation, and research

program or activity purposes.

(b) Period covered as affecting

applicability. The provisions of §§ 1.460

through 1.499 of this part apply to

records of identity, diagnosis, prognosis,

or treatment pertaining to any given

individual maintained over any period

of time which, irrespective of when it

begins, does not end before March 21,

1972, in the case of diagnosis or

treatment for drug abuse; or before May

14, 1974, in the case of diagnosis or

treatment for alcoholism or alcohol

abuse; or before September 1, 1973, in

the case of testing, diagnosis or

treatment of sickle cell anemia; or before

May 20, 1988, in the case of testing,

diagnosis or treatment for an infection

with the HIV.

(c) Exceptions.

(1) Department of Veterans Affairs

and Armed Forces. The restrictions on

disclosure in §§ 1.460 through 1.499 of

this part do not apply to

communications of information between

or among those components of VA who

have a need for the information in

connection with their duties in the

provision of health care, adjudication of

benefits, or in carrying out

administrative responsibilities related to

those functions, including personnel of

the Office of the Inspector General who

are conducting audits, evaluations,

healthcare inspections, or non-patient

investigations, or between such

components and the Armed Forces, of

information pertaining to a person

relating to a period when such person

is or was subject to the Uniform Code

of Military Justice. Information obtained

by VA components under these

circumstances may be disclosed outside

of VA to prosecute or investigate a nonpatient only in accordance with § 1.495

of this part. Similarly, the restrictions

on disclosure in §§ 1.460 through 1.499

of this part do not apply to

communications of information to the

Department of Justice or U.S. Attorneys

who are providing support in civil

litigation or possible litigation involving

VA.

(2) Contractor. The restrictions on

disclosure in §§ 1.460 through 1.499 of

this part do not apply to

communications between VA and a

contractor of information needed by the

contractor to provide his or her services.

(3) Crimes on VA premises or against

VA personnel. The restrictions on

disclosure and use in §§ 1.460 through

1.499 of this part do not apply to

communications from VA personnel to

law enforcement officers which:

(i) Are directly related to a patient’s

commission of a crime on the premises

of the facility or against personnel of VA

or to a threat to commit such a crime;

and

(ii) Are limited to the circumstances

of the incident, including the patient

status of the individual committing or

threatening to commit the crime, that

individual’s name and address to the

extent authorized by 38 U.S.C.

5701(f)(2), and that individual’s last

known whereabouts.

(4) Undercover agents and

informants.

(i) Except as specifically authorized

by a court order granted under § 1.495

of this part, VA may not knowingly

employ, or admit as a patient, any

undercover agent or informant in any

VA drug abuse, alcoholism or alcohol

abuse, HIV infection, or sickle cell

anemia treatment program.

(ii) No information obtained by an

undercover agent or informant, whether

or not that undercover agent or

informant is placed in a VA drug abuse,

alcoholism or alcohol abuse, HIV

infection, or sickle cell anemia

treatment program pursuant to an

authorizing court order, may be used to

criminally investigate or prosecute any

patient unless authorized pursuant to

the provisions of § 1.494 of this part.

(iii) The enrollment of an undercover

agent or informant in a treatment unit

shall not be deemed a violation of this

section if the enrollment is solely for the

purpose of enabling the individual to

obtain treatment for drug or alcohol

abuse, HIV infection, or sickle cell

anemia.

(d) Applicability to recipients of

information.

(1) Restriction on use of information.

In the absence of a proper § 1.494 court

order, the restriction on the use of any

information subject to §§ 1.460 through

1.499 of this part to initiate or
63932 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations

substantiate any criminal charges

against a patient or to conduct any

criminal investigation of a patient

applies to any person who obtains that

information from VA, regardless of the

status of the person obtaining the

information or of whether the

information was obtained in accordance

with §§ 1.460 through 1.499 of this part.

This restriction on use bars, among

other things, the introduction of that

information as evidence in a criminal

proceeding and any other use of the

information to investigate or prosecute a

patient with respect to a suspected

crime. Information obtained by

undercover agents or informants (see

paragraph (c) of this section) or through

patient access (see § 1.469 of this part)

is subject to the restriction on use.

(2) Restrictions on disclosures—thirdparty payers and others. The restrictions

on disclosure in §§ 1.460 through 1.499

of this part apply to third-party payers

and persons who, pursuant to a consent,

receive patient records directly from VA

and who are notified of the restrictions

on redisclosure of the records in

accordance with § 1.476 of this part.

(Authority: 38 U.S.C. 7332(e) and 7334)

§ 1.462 Confidentiality restrictions.

(a) General. The patient records to

which §§ 1.460 through 1.499 of this

part apply may be disclosed or used

only as permitted by these regulations

and may not otherwise be disclosed or

used in any civil, criminal,

administrative, or legislative

proceedings conducted by any Federal,

State, or local authority. Any disclosure

made under these regulations must be

limited to that information which is

necessary to carry out the purpose of the

disclosure.

(b) Unconditional compliance

required. The restrictions on disclosure

and use in §§ 1.460 through 1.499 of this

part apply whether the person seeking

the information already has it, has other

means of obtaining it, is a law

enforcement or other official, has

obtained a subpoena, or asserts any

other justification for a disclosure or use

which is not permitted by §§ 1.460

through 1.499 of this part. These

provisions do not prohibit VA from

acting accordingly when there is no

disclosure of information.

(c) Acknowledging the presence of

patients: responding to requests.

(1) The presence of an identified

patient in a VA facility for the treatment

or other VA program activity relating to

drug abuse, alcoholism or alcohol abuse,

infection with the HIV, or sickle cell

anemia may be acknowledged only if

the patient’s written consent is obtained

in accordance with § 1.475 of this part

or if an authorizing court order is

entered in accordance with §§ 1.490

through 1.499 of this part.

Acknowledgment of the presence of an

identified patient in a facility is

permitted if the acknowledgment does

not reveal that the patient is being

treated for or is otherwise involved in a

VA program or activity concerning drug

abuse, alcoholism or alcohol abuse,

infection with the HIV, or sickle cell

anemia.

(2) Any answer to a request for a

disclosure of patient records which is

not permissible under §§ 1.460 through

1.499 of this part must be made in a way

that will not affirmatively reveal that an

identified individual has been, or is

being diagnosed or treated for drug

abuse, alcoholism or alcohol abuse,

infection with the HIV, or sickle cell

anemia. These regulations do not

restrict a disclosure that an identified

individual is not and never has been a

patient.

(Authority: 38 U.S.C. 7334)

§ 1.463 Criminal penalty for violations.

Under 38 U.S.C. 7332(g), any person

who violates any provision of this

statute or §§ 1.460 through 1.499 of this

part shall be fined not more than $5,000

in the case of a first offense, and not

more than $20,000 for a subsequent

offense.

(Authority: 38 U.S.C. 7332(g))

§ 1.464 Minor patients.

(a) Definition of minor. As used in

§§ 1.460 through 1.499 of this part the

term ‘‘minor’’ means a person who has

not attained the age of majority

specified in the applicable State law, or

if no age of majority is specified in the

applicable State law, the age of eighteen

years.

(b) State law not requiring parental

consent to treatment. If a minor patient

acting alone has the legal capacity under

the applicable State law to apply for and

obtain treatment for drug abuse,

alcoholism or alcohol abuse, infection

with the HIV, or sickle cell anemia, any

written consent for disclosure

authorized under § 1.475 of this part

may be given only by the minor patient.

This restriction includes, but is not

limited to, any disclosure of patient

identifying information to the parent or

guardian of a minor patient for the

purpose of obtaining financial

reimbursement. Sections 1.460 through

1.499 of this part do not prohibit a VA

facility from refusing to provide

nonemergent treatment to an otherwise

ineligible minor patient until the minor

patient consents to the disclosure

necessary to obtain reimbursement for

services from a third party payer.

(c) State law requiring parental

consent to treatment.

(1) Where State law requires consent

of a parent, guardian, or other person for

a minor to obtain treatment for drug

abuse, alcoholism or alcohol abuse,

infection with the HIV, or sickle cell

anemia, any written consent for

disclosure authorized under § 1.475 of

this part must be given by both the

minor and his or her parent, guardian,

or other person authorized under State

law to act in the minor’s behalf.

(2) Where State law requires parental

consent to treatment, the fact of a

minor’s application for treatment may

be communicated to the minor’s parent,

guardian, or other person authorized

under State law to act in the minor’s

behalf only if:

(i) The minor has given written

consent to the disclosure in accordance

with § 1.475 of this part; or

(ii) The minor lacks the capacity to

make a rational choice regarding such

consent as judged by the appropriate VA

facility director under paragraph (d) of

this section.

(d) Minor applicant for service lacks

capacity for rational choice. Facts

relevant to reducing a threat to the life

or physical well being of the applicant

or any other individual may be

disclosed to the parent, guardian, or

other person authorized under State law

to act in the minor’s behalf if the

appropriate VA facility director judges

that:

(1) A minor applicant for services

lacks capacity because of extreme youth

or mental or physical condition to make

a rational decision on whether to

consent to a disclosure under § 1.475 of

this part to his or her parent, guardian,

or other person authorized under State

law to act in the minor’s behalf, and

(2) The applicant’s situation poses a

substantial threat to the life or physical

well-being of the applicant or any other

individual which may be reduced by

communicating relevant facts to the

minor’s parent, guardian, or other

person authorized under State law to act

in the minor’s behalf.

(Authority: 38 U.S.C. 7334)

§ 1.465 Incompetent and deceased

patients.

(a) Incompetent patients other than

minors. In the case of a patient who has

been adjudicated as lacking the

capacity, for any reason other than

insufficient age, to manage his or her

own affairs, any consent which is

required under §§ 1.460 through 1.499

of this part may be given by a court

appointed legal guardian.
Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations 63933

(b) Deceased patients.

(1) Vital statistics. Sec. 1.460 through

1.499 of this part do not restrict the

disclosure of patient identifying

information relating to the cause of

death of a patient under laws requiring

the collection of death or other vital

statistics or permitting inquiry into the

cause of death.

(2) Consent by personal

representative. Any other disclosure of

information identifying a deceased

patient as being treated for drug abuse,

alcoholism or alcohol abuse, infection

with the HIV, or sickle cell anemia is

subject to §§ 1.460 through 1.499 of this

part. If a written consent to the

disclosure is required, the Under

Secretary for Health or designee may,

upon the prior written request of the

next of kin, executor/executrix,

administrator/administratrix, or other

personal representative of such

deceased patient, disclose the contents

of such records, only if the Under

Secretary for Health or designee

determines such disclosure is necessary

to obtain survivorship benefits for the

deceased patient’s survivor. This would

include not only VA benefits, but also

payments by the Social Security

Administration, Worker’s Compensation

Boards or Commissions, or other

Federal, State, or local government

agencies, or nongovernment entities,

such as life insurance companies.

(3) Information related to sickle cell

anemia. Information related to sickle

cell anemia may be released to a blood

relative of a deceased veteran for

medical follow-up or family planning

purposes.

(Authority: 38 U.S.C. 7332(b)(3))

§ 1.466 Security for records.

(a) Written records which are subject

to §§ 1.460 through 1.499 of this part

must be maintained in a secure room,

locked file cabinet, safe or other similar

container when not in use. Access to

information stored in computers will be

limited to authorized VA employees

who have a need for the information in

performing their duties. These security

precautions shall be consistent with the

Privacy Act of 1974 (5 U.S.C. 552a).

(b) Each VA facility shall adopt in

writing procedures related to the access

to and use of records which are subject

to §§ 1.460 through 1.499 of this part.

(Authority: 38 U.S.C. 7334)

§ 1.467 Restrictions on the use of

identification cards and public signs.

(a) No facility may require any patient

to carry on their person while away

from the facility premises any card or

other object which would identify the

patient as a participant in any VA drug

abuse, alcoholism or alcohol abuse, HIV

infection, or sickle cell anemia

treatment program. A facility may

require patients to use or carry cards or

other identification objects on the

premises of a facility. Patients may not

be required to wear clothing or colored

identification bracelets or display

objects openly to all facility staff or

others which would identify them as

being treated for drug or alcohol abuse,

HIV infection, or sickle cell anemia.

(b) Treatment locations should not be

identified by signs that would identify

individuals entering or exiting these

locations as patients enrolled in a drug

or alcohol abuse, HIV infection, or

sickle cell anemia program or activity.

(Authority: 38 U.S.C. 7334)

§ 1.468 Relationship to Federal statutes

protecting research subjects against

compulsory disclosure of their identity.

(a) Research privilege description.

There may be concurrent coverage of

patient identifying information by the

provisions of §§ 1.460 through 1.499 of

this part and by administrative action

taken under Sec. 303(a) of the Public

Health Service Act (42 U.S.C. 241(d)

and the implementing regulations at 42

CFR Part 2a); or Sec. 502(c) of the

Controlled Substances Act (21 U.S.C.

872(c) and the implementing regulations

at 21 CFR 1316.21). These ‘‘research

privilege’’ statutes confer on the

Secretary of Health and Human Services

and on the Attorney General,

respectively, the power to authorize

researchers conducting certain types of

research to withhold from all persons

not connected with the research the

names and other identifying information

concerning individuals who are the

subjects of the research.

(b) Effect of concurrent coverage.

Sections 1.460 through 1.499 of this part

restrict the disclosure and use of

information about patients, while

administrative action taken under the

research privilege statutes and

implementing regulations protects a

person engaged in applicable research

from being compelled to disclose any

identifying characteristics of the

individuals who are the subjects of that

research. The issuance under §§ 1.490

through 1.499 of this part of a court

order authorizing a disclosure of

information about a patient does not

affect an exercise of authority under

these research privilege statutes.

However, the research privilege granted

under 21 CFR 291.505(g) to treatment

programs using methadone for

maintenance treatment does not protect

from compulsory disclosure any

information which is permitted to be

disclosed under those regulations. Thus,

if a court order entered in accordance

with §§ 1.490 through 1.499 of this part

authorizes a VA facility to disclose

certain information about its patients,

the facility may not invoke the research

privilege under 21 CFR 291.505(g) as a

defense to a subpoena for that

information.

(Authority: 38 U.S.C. 7334)

§ 1.469 Patient access and restrictions on

use.

(a) Patient access not prohibited.

Sections 1.460 through 1.499 of this part

do not prohibit a facility from giving a

patient access to his or her own records,

including the opportunity to inspect

and copy any records that VA maintains

about the patient, subject to the

provisions of the Privacy Act (5 U.S.C.

552a(d)(1)) and 38 CFR 1.577. If the

patient is accompanied, giving access to

the patient and the accompanying

person will require a written consent by

the patient which is provided in

accordance with § 1.475 of this part.

(b) Restrictions on use of information.

Information obtained by patient access

to patient record is subject to the

restriction on use of this information to

initiate or substantiate any criminal

charges against the patient or to conduct

any criminal investigation of the patient

as provided for under § 1.461(d)(1) of

this part.

(Authority: 38 U.S.C. 7334)

§§ 1.470–1.474 [Reserved]

Disclosures With Patient’s Consent

§ 1.475 Form of written consent.

(a) Required elements. A written

consent to a disclosure under §§ 1.460

through 1.499 of this part must include:

(1) The name of the facility permitted

to make the disclosure (such a

designation does not preclude the

release of records from other VA health

care facilities unless a restriction is

stated on the consent).

(2) The name or title of the individual

or the name of the organization to which

disclosure is to be made.

(3) The name of the patient.

(4) The purpose of the disclosure.

(5) How much and what kind of

information is to be disclosed.

(6) The signature of the patient and,

when required for a patient who is a

minor, the signature of a person

authorized to give consent under § 1.464

of this part; or, when required for a

patient who is incompetent or deceased,

the signature of a person authorized to

sign under § 1.465 of this part in lieu of

the patient.

(7) The date on which the consent is

signed.
63934 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations

(8) A statement that the consent is

subject to revocation at any time except

to the extent that the facility which is

to make the disclosure has already acted

in reliance on it. Acting in reliance

includes the provision of treatment

services in reliance on a valid consent

to disclose information to a third party

payer.

(9) The date, event, or condition upon

which the consent will expire if not

revoked before. This date, event, or

condition must ensure that the consent

will last no longer than reasonably

necessary to serve the purpose for

which it is given.

(b) Expired, deficient, or false

consent. A disclosure may not be made

on the basis of a consent which:

(1) Has expired;

(2) On its face substantially fails to

conform to any of the requirements set

forth in paragraph (a) of this section;

(3) Is known to have been revoked; or

(4) Is known, or through a reasonable

effort could be known, by responsible

personnel of VA to be materially false.

(c) Notification of deficient consent.

Other than the patient, no person or

entity may be advised that a special

consent is required in order to disclose

information relating to an individual

participating in a drug abuse,

alcoholism or alcohol abuse, HIV, or

sickle cell anemia program or activity.

Where a person or entity presents VA

with an insufficient written consent for

information protected by 38 U.S.C.

7332, VA must, in the process of

obtaining a legally sufficient consent,

correspond only with the patient whose

records are involved, or the legal

guardian of an incompetent patient or

next of kin of a deceased patient, and

not with any other person.

(d) It is not necessary to use any

particular form to establish a consent

referred to in paragraph (a) of this

section, however, VA Form 10–5345,

titled Request for and Consent to

Release of Medical Records Protected by

38 U.S.C. 7332, may be used for such

purpose.

(Authority: 38 U.S.C. 7332(a)(2) and (b)(1))

§ 1.476 Prohibition on redisclosure.

Each disclosure under §§ 1.460

through 1.499 of this part made with the

patient’s written consent must be

accompanied by a written statement

similar to the following:

This information has been disclosed to you

from records protected by Federal

confidentiality rules (38 CFR Part 1). The

Federal rules prohibit you from making any

further disclosure of this information unless

further disclosure is expressly permitted by

the written consent of the person to whom it

pertains or as otherwise permitted by 38 CFR

Part 1. A general authorization for the release

of medical or other information is NOT

sufficient for this purpose. The Federal rules

restrict any use of the information to

criminally investigate or prosecute any

alcohol or drug abuse patient or patient with

sickle cell anemia or HIV infection.

(Authority: 38 U.S.C. 7334)

§ 1.477 Disclosures permitted with written

consent.

If a patient consents to a disclosure of

his or her records under § 1.475 of this

part, a facility may disclose those

records in accordance with that consent

to any individual or organization named

in the consent, except that disclosures

to central registries and in connection

with criminal justice referrals must meet

the requirements of §§ 1.478 and 1.479

of this part, respectively.

(Authority: 38 U.S.C. 7332(b)(1))

§ 1.478 Disclosures to prevent multiple

enrollments in detoxification and

maintenance treatment programs; not

applicable to records relating to sickle cell

anemia or infection with the HIV.

(a) Definitions.

For purposes of this section:

(1) Central registry means an

organization which obtains from two or

more member programs patient

identifying information about

individuals applying for maintenance

treatment or detoxification treatment for

the purpose of avoiding an individual’s

concurrent enrollment in more than one

program.

(2) Detoxification treatment means the

dispensing of a narcotic drug in

decreasing doses to an individual in

order to reduce or eliminate adverse

physiological or psychological effects

incident to withdrawal from the

sustained use of a narcotic drug.

(3) Maintenance treatment means the

dispensing of a narcotic drug in the

treatment of an individual for

dependence upon heroin or other

morphine-like drugs.

(4) Member program means a non-VA

detoxification treatment or maintenance

treatment program which reports patient

identifying information to a central

registry and which is in the same State

as that central registry or is not more

than 125 miles from any border of the

State in which the central registry is

located.

(b) Restrictions on disclosure. VA may

disclose patient records to a central

registry which is located in the same

State or is not more than 125 miles from

any border of the State or to any nonVA detoxification or maintenance

treatment program not more than 200

miles away for the purpose of

preventing the multiple enrollment of a

patient only if:

(1) The disclosure is made when:

(i) The patient is accepted for

treatment;

(ii) The type or dosage of the drug is

changed; or

(iii) The treatment is interrupted,

resumed or terminated.

(2) The disclosure is limited to:

(i) Patient identifying information;

(ii) Type and dosage of the drug; and

(iii) Relevant dates.

(3) The disclosure is made with the

patient’s written consent meeting the

requirements of § 1.475 of this part,

except that:

(i) The consent must list the name and

address of each central registry and each

known non-VA detoxification or

maintenance treatment program to

which a disclosure will be made; and

(ii) The consent may authorize a

disclosure to any non-VA detoxification

or maintenance treatment program

established within 200 miles after the

consent is given without naming any

such program.

(c) Use of information limited to

prevention of multiple enrollments. A

central registry and any non-VA

detoxification or maintenance treatment

program to which information is

disclosed to prevent multiple

enrollments may not redisclose or use

patient identifying information for any

purpose other than the prevention of

multiple enrollments unless authorized

by a court order under §§ 1.490 through

1.499 of this part.

(Authority: 38 U.S.C. 7334)

§ 1.479 Disclosures to elements of the

criminal justice system which have referred

patients.

(a) VA may disclose information

about a patient from records covered by

§§ 1.460 through 1.499 of this part to

those persons within the criminal

justice system which have made

participation in a VA treatment program

a condition of the disposition of any

criminal proceedings against the patient

or of the patient’s parole or other release

from custody if:

(1) The disclosure is made only to

those individuals within the criminal

justice system who have a need for the

information in connection with their

duty to monitor the patient’s progress

(e.g., a prosecuting attorney who is

withholding charges against the patient,

a court granting pretrial or posttrial

release, probation or parole officers

responsible for supervision of the

patient); and

(2) The patient has signed a written

consent as a condition of admission to

the treatment program meeting the

requirements of § 1.475 of this part

(except paragraph (a)(8) which is
Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations 63935

inconsistent with the revocation

provisions of paragraph (c) of this

section) and the requirements of

paragraphs (b) and (c) of this section.

(b) Duration of consent. The written

consent must state the period during

which it remains in effect. This period

must be reasonable, taking into account:

(1) The anticipated length of the

treatment recognizing that revocation of

consent may not generally be effected

while treatment is ongoing;

(2) The type of criminal proceeding

involved, the need for the information

in connection with the final disposition

of that proceeding, and when the final

disposition will occur; and

(3) Such other factors as the facility,

the patient, and the person(s) who will

receive the disclosure consider

pertinent.

(c) Revocation of consent. The written

consent must state that it is revocable

upon the passage of a specified amount

of time or the occurrence of a specified,

ascertainable event. The time or

occurrence upon which consent

becomes revocable may be no earlier

than the individual’s completion of the

treatment program and no later than the

final disposition of the conditional

release or other action in connection

with which consent was given.

(d) Restrictions on redisclosure and

use. A person who receives patient

information under this section may

redisclose and use it only to carry out

that person’s official duties with regard

to the patient’s conditional release or

other action in connection with which

the consent was given, including parole.

(Authority: 38 U.S.C. 7334)

§§ 1.480–1.484 [Reserved]

Disclosures Without Patient Consent

§ 1.485 Medical emergencies.

(a) General rule. Under the procedures

required by paragraph (c) of this section,

patient identifying information from

records covered by §§ 1.460 through

1.499 of this part may be disclosed to

medical personnel who have a need for

information about a patient for the

purpose of treating a condition which

poses an immediate threat to the health

of any individual and which requires

immediate medical intervention.

(b) Special rule. Patient identifying

information may be disclosed to

medical personnel of the Food and Drug

Administration (FDA) who assert a

reason to believe that the health of any

individual may be threatened by an

error in the manufacture, labeling, or

sale of a product under FDA

jurisdiction, and that the information

will be used for the exclusive purpose

of notifying patients or their physicians

of potential dangers.

(c) Procedures. Immediately following

disclosure, any VA employee making an

oral disclosure under authority of this

section shall make an accounting of the

disclosure in accordance with the

Privacy Act (5 U.S.C. 552a(c) and 38

CFR 1.576(c)) and document the

disclosure in the patient’s records

setting forth in writing:

(1) The name and address of the

medical personnel to whom disclosure

was made and their affiliation with any

health care facility;

(2) The name of the individual

making the disclosure;

(3) The date and time of the

disclosure;

(4) The nature of the emergency (or

error, if the report was to FDA);

(5) The information disclosed; and

(6) The authority for making the

disclosure (§ 1.485 of this part).

(Authority: 38 U.S.C. 7332(b)(2)(A))

§ 1.486 Disclosure of information related

to infection with the human

immunodeficiency virus to public health

authorities.

(a) In the case of any record which is

maintained in connection with the

performance of any program or activity

relating to infection with the HIV,

information may be disclosed to a

Federal, State, or local public health

authority, charged under Federal or

State law with the protection of the

public health, and to which Federal or

State law requires disclosure of such

record, if a qualified representative of

such authority has made a written

request that such record be provided as

required pursuant to such law for a

purpose authorized by such law. In the

case of a State law, such law must, in

order for VA to be able to release patient

name and address information in

accordance with 38 U.S.C. 5701(f)(2),

provide for a penalty or fine or other

sanction to be assessed against those

individuals who are subject to the

jurisdiction of the public health

authority but fail to comply with the

reporting requirements.

(b) A person to whom a record is

disclosed under this section may not

redisclose or use such record for a

purpose other than that for which the

disclosure was made.

(Authority: 38 U.S.C. 7332(b)(2)(C))

§ 1.487 Disclosure of information related

to infection with the human

immunodeficiency virus to the spouse or

sexual partner of the patient.

(a) Subject to paragraph (b) of this

section, a physician or a professional

counselor may disclose information or

records indicating that a patient is

infected with the HIV if the disclosure

is made to the spouse of the patient, or

to an individual whom the patient has,

during the process of professional

counseling or of testing to determine

whether the patient is infected with

such virus, identified as being a sexual

partner of such patient.

(b) A disclosure under this section

may be made only if the physician or

counselor, after making reasonable

efforts to counsel and encourage the

patient to provide the information to the

spouse or sexual partner, reasonably

believes that the patient will not

provide the information to the spouse or

sexual partner and that the disclosure is

necessary to protect the health of the

spouse or sexual partner.

(c) A disclosure under this section

may be made by a physician or

counselor other than the physician or

counselor referred to in paragraph (b) of

this section if such physician or

counselor is unavailable by reason of

extended absence or termination of

employment to make the disclosure.

(Authority: 38 U.S.C. 7332(b))

§ 1.488 Research activities.

Subject to the provisions of 38 U.S.C.

5701, 38 CFR 1.500–1.527, the Privacy

Act (5 U.S.C. 552a), 38 CFR 1.575–1.584

and the following paragraphs, patient

medical record information covered by

§§ 1.460 through 1.499 of this part may

be disclosed for the purpose of

conducting scientific research.

(a) Information in individually

identifiable form may be disclosed from

records covered by §§ 1.460 through

1.499 of this part for the purpose of

conducting scientific research if the

Under Secretary for Health or designee

makes a determination that the recipient

of the patient identifying information:

(1) Is qualified to conduct the

research.

(2) Has a research protocol under

which the information:

(i) Will be maintained in accordance

with the security requirements of

§ 1.466 of this part (or more stringent

requirements); and

(ii) Will not be redisclosed except as

permitted under paragraph (b) of this

section.

(3) Has furnished a written statement

that the research protocol has been

reviewed by an independent group of

three or more individuals who found

that the rights of patients would be

adequately protected and that the

potential benefits of the research

outweigh any potential risks to patient

confidentiality posed by the disclosure

of records.
63936 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations

(b) A person conducting research may

disclose information obtained under

paragraph (a) of this section only back

to VA and may not identify any

individual patient in any report of that

research or otherwise disclose patient

identities.

(Authority: 38 U.S.C. 7332(b)(2)(B))

§ 1.489 Audit and evaluation activities.

Subject to the provisions of 38 U.S.C.

5701, 38 CFR 1.500–1.527, the Privacy

Act (5 U.S.C. 552a), 38 CFR 1.575–

1.584, and the following paragraphs,

patient medical records covered by

§§ 1.460 through 1.499 of this part may

be disclosed outside VA for the

purposes of conducting audit and

evaluation activities.

(a) Records not copies. If patient

records covered by §§ 1.460 through

1.499 of this part are not copied, patient

identifying information may be

disclosed in the course of a review of

records on VA facility premises to any

person who agrees in writing to comply

with the limitations on redisclosure and

use in paragraph (d) of this section and:

(1) Where audit or evaluation

functions are performed by a State or

Federal governmental agency on behalf

of VA; or

(2) Who is determined by the VA

facility director to be qualified to

conduct the audit or evaluation

activities.

(b) Copying of records. Records

containing patient identifying

information may be copied by any

person who:

(1) Agrees in writing to:

(i) Maintain the patient identifying

information in accordance with the

security requirements provided in

§ 1.466 of this part (or more stringent

requirements);

(ii) Destroy all the patient identifying

information upon completion of the

audit or evaluation; and

(iii) Comply with the limitations on

disclosure and use in paragraph (d) of

this section.

(2) The VA medical facility director

determines to be qualified to conduct

the audit or evaluation activities.

(c) Congressional oversight. Records

subject to §§ 1.460 through 1.499 of this

part upon written request may be

released to congressional committees or

subcommittees for program oversight

and evaluation if such records pertain to

any matter within the jurisdiction of

such committee or subcommittee.

(d) Limitation on disclosure and use.

Records containing patient identifying

information disclosed under this section

may be disclosed only back to VA and

used only to carry out an audit or

evaluation purpose, or, to investigate or

prosecute criminal or other activities as

authorized by a court order entered

under § 1.494 of this part.

(Authority: 38 U.S.C. 7332(b)(2)(B))

Court Orders Authorizing Disclosures

and Use

§ 1.490 Legal effect of order.

The records to which §§ 1.460

through 1.499 of this part apply may be

disclosed if authorized by an

appropriate order of a court of

competent jurisdiction granted after

application showing good cause

therefore. In assessing good cause the

court is statutorily required to weigh the

public interest and the need for

disclosure against the injury to the

patient or subject, to the physicianpatient relationship, and to the

treatment services. Upon the granting of

such order, the court, in determining the

extent to which any disclosure of all or

any part of any record is necessary, is

required by statute to impose

appropriate safeguards against

unauthorized disclosure. An order of a

court of competent jurisdiction to

produce records subject to §§ 1.460

through 1.499 of this part will not be

sufficient unless the order reflects that

the court has complied with the

requirements of 38 U.S.C. 7332(b)(2)(D).

Such an order from a Federal court

compels disclosure. However, such an

order from a State court only acts to

authorize the Secretary to exercise

discretion pursuant to 38 U.S.C.

5701(b)(5) and 38 CFR 1.511 to disclose

such records. It does not compel

disclosure.

(Authority: 38 U.S.C. 7332(b)(2)(D))

§ 1.491 Confidential communications.

(a) A court order under §§ 1.490

through 1.499 of this part may authorize

disclosure of confidential

communications made by a patient to a

treatment program in the course of

diagnosis, treatment, or referral for

treatment only if:

(1) The disclosure is necessary to

protect against an existing threat to life

or of serious bodily injury, including

circumstances which constitute

suspected child abuse and neglect and

verbal threats against third parties;

(2) The disclosure is necessary in

connection with investigation or

prosecution of an extremely serious

crime, such as one which directly

threatens loss of life or serious bodily

injury, including homicide, rape,

kidnapping, armed robbery, assault with

a deadly weapon, or child abuse and

neglect; or

(3) The disclosure is in connection

with litigation or an administrative

proceeding in which the patient offers

testimony or other evidence pertaining

to the content of the confidential

communications.

(Authority: 38 U.S.C. 7334)

§ 1.492 Order not applicable to records

disclosed without consent to researchers,

auditors and evaluators.

A court order under §§ 1.460 through

1.499 of this part may not authorize

qualified personnel, who have received

patient identifying information from VA

without consent for the purpose of

conducting research, audit or

evaluation, to disclose that information

or use it to conduct any criminal

investigation or prosecution of a patient.

However, a court order under § 1.495 of

this part may authorize disclosure and

use of records to investigate or

prosecute VA personnel.

(Authority: 38 U.S.C. 7334)

§ 1.493 Procedures and criteria for orders

authorizing disclosures for noncriminal

purposes.

(a) Application. An order authorizing

the disclosure of patient records covered

by §§ 1.460 through 1.499 of this part for

purposes other than criminal

investigation or prosecution may be

applied for by any person having a

legally recognized interest in the

disclosure which is sought. The

application may be filed separately or as

part of a pending civil action in which

it appears that the patient records are

needed to provide evidence. An

application must use a fictitious name,

such as John Doe, to refer to any patient

and may not contain or otherwise

disclose any patient identifying

information unless the patient is the

applicant or has given a written consent

(meeting the requirements of § 1.475 of

this part) to disclosure or the court has

ordered the record of the proceeding

sealed from public scrutiny.

(b) Notice. The patient and VA facility

from whom disclosure is sought must be

given:

(1) Adequate notice in a manner

which will not disclose patient

identifying information to other

persons; and

(2) An opportunity to file a written

response to the application, or to appear

in person, for the limited purpose of

providing evidence on whether the

statutory and regulatory criteria for the

issuance of the court order are met.

(c) Review of evidence: Conduct of

hearing. Any oral argument, review of

evidence, or hearing on the application

must be held in the judge’s chambers or

in some manner which ensures that

patient identifying information is not

disclosed to anyone other than a party
Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations 63937

to the proceeding, the patient, or VA,

unless the patient requests an open

hearing in a manner which meets the

written consent requirements of § 1.475

of this part. The proceeding may

include an examination by the judge of

the patient records referred to in the

application.

(d) Criteria for entry of order. An

order under this section may be entered

only if the court determines that good

cause exists. To make this

determination the court must find that:

(1) Other ways of obtaining the

information are not available or would

not be effective; and

(2) The public interest and need for

the disclosure outweigh the potential

injury to the patient, the physicianpatient relationship and the treatment

services.

(e) Content of order. An order

authorizing a disclosure must:

(1) Limit disclosure to those parts of

the patient’s record which are essential

to fulfill the objective of the order;

(2) Limit disclosure to those persons

whose need for information is the basis

for the order; and

(3) Include such other measures as are

necessary to limit disclosure for the

protection of the patient, the physicianpatient relationship and the treatment

services; for example, sealing from

public scrutiny the record of any

proceeding for which disclosure of a

patient’s record has been ordered.

(Authority: 38 U.S.C. 7334)

§ 1.494 Procedures and criteria for orders

authorizing disclosure and use of records

to criminally investigate or prosecute

patients.

(a) Application. An order authorizing

the disclosure or use of patient records

covered by §§ 1.460 through 1.499 of

this part to criminally investigate or

prosecute a patient may be applied for

by VA or by any person conducting

investigative or prosecutorial activities

with respect to the enforcement of

criminal laws. The application may be

filed separately, as part of an

application for a subpoena or other

compulsory process, or in a pending

criminal action. An application must

use a fictitious name such as John Doe,

to refer to any patient and may not

contain or otherwise disclose patient

identifying information unless the court

has ordered the record of the proceeding

sealed from public scrutiny.

(b) Notice and hearing. Unless an

order under § 1.495 of this part is sought

with an order under this section, VA

must be given:

(1) Adequate notice (in a manner

which will not disclose patient

identifying information to third parties)

of an application by a person

performing a law enforcement function;

(2) An opportunity to appear and be

heard for the limited purpose of

providing evidence on the statutory and

regulatory criteria for the issuance of the

court order; and

(3) An opportunity to be represented

by counsel.

(c) Review of evidence: Conduct of

hearings. Any oral argument, review of

evidence, or hearing on the application

shall be held in the judge’s chambers or

in some other manner which ensures

that patient identifying information is

not disclosed to anyone other than a

party to the proceedings, the patient, or

VA. The proceeding may include an

examination by the judge of the patient

records referred to in the application.

(d) Criteria. A court may authorize the

disclosure and use of patient records for

the purpose of conducting a criminal

investigation or prosecution of a patient

only if the court finds that all of the

following criteria are met:

(1) The crime involved is extremely

serious, such as one which causes or

directly threatens loss of life or serious

bodily injury including, but not limited

to, homicide, rape, kidnapping, armed

robbery, assault with a deadly weapon,

and child abuse and neglect.

(2) There is a reasonable likelihood

that the records will disclose

information of substantial value in the

investigation or prosecution.

(3) Other ways of obtaining the

information are not available or would

not be effective.

(4) The potential injury to the patient,

to the physician-patient relationship

and to the ability of VA to provide

services to other patients is outweighed

by the public interest and the need for

the disclosure.

(5) If the applicant is a person

performing a law enforcement function,

VA has been represented by counsel

independent of the applicant.

(e) Content of order. Any order

authorizing a disclosure or use of

patient records under this section must:

(1) Limit disclosure and use to those

parts of the patient’s record which are

essential to fulfill the objective of the

order;

(2) Limit disclosure to those law

enforcement and prosecutorial officials

who are responsible for, or are

conducting, the investigation or

prosecution, and limit their use of the

records to investigation and prosecution

of extremely serious crime or suspected

crime specified in the applications; and

(3) Include such other measures as are

necessary to limit disclosure and use to

the fulfillment on only that public

interest and need found by the court.

(Authority: 38 U.S.C. 7332(c))

§ 1.495 Procedures and criteria for orders

authorizing disclosure and use of records

to investigate or prosecute VA or

employees of VA.

(a) Application.

(1) An order authorizing the

disclosure or use of patient records

covered by §§ 1.460 through 1.499 of

this part to criminally or

administratively investigate or

prosecute VA (or employees or agents of

VA) may be applied for by an

administrative, regulatory, supervisory,

investigative, law enforcement, or

prosecutorial agency having jurisdiction

over VA activities.

(2) The application may be filed

separately or as part of a pending civil

or criminal action against VA (or agents

or employees of VA) in which it appears

that the patient records are needed to

provide material evidence. The

application must use a fictitious name,

such as John Doe, to refer to any patient

and may not contain or otherwise

disclose any patient identifying

information unless the court has

ordered the record of the proceeding

sealed from public scrutiny or the

patient has given a written consent

(meeting the requirements of § 1.475 of

this part) to that disclosure.

(b) Notice not required. An

application under this section may, in

the discretion of the court, be granted

without notice. Although no express

notice is required to VA or to any

patient whose records are to be

disclosed, upon implementation of an

order so granted VA or the patient must

be afforded an opportunity to seek

revocation or amendment of that order,

limited to the presentation of evidence

on the statutory and regulatory criteria

for the issuance of the court order.

(c) Requirements for order. An order

under this section must be entered in

accordance with, and comply with the

requirements of, § 1.493(d) and (e) of

this part.

(d) Limitations on disclosure and use

of patient identifying information.

(1) An order entered under this

section must require the deletion of

patient identifying information from any

documents made available to the public.

(2) No information obtained under

this section may be used to conduct any

investigation or prosecution of a patient,

or be used as the basis for an application

for an order under § 1.494 of this part.

(Authority: 38 U.S.C. 7334)
63938 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations

§ 1.496 Orders authorizing the use of

undercover agents and informants to

criminally investigate employees or agents

of VA.

(a) Application. A court order

authorizing the placement of an

undercover agent or informant in a VA

drug or alcohol abuse, HIV infection, or

sickle cell anemia treatment program as

an employee or patient may be applied

for by any law enforcement or

prosecutorial agency which has reason

to believe that employees or agents of

the VA treatment program are engaged

in criminal misconduct.

(b) Notice. The VA facility director

must be given adequate notice of the

application and an opportunity to

appear and be heard (for the limited

purpose of providing evidence on the

statutory and regulatory criteria for the

issuance of the court order), unless the

application asserts a belief that:

(1) The VA facility director is

involved in the criminal activities to be

investigated by the undercover agent or

informant; or

(2) The VA facility director will

intentionally or unintentionally disclose

the proposed placement of an

undercover agent or informant to the

employees or agents who are suspected

of criminal activities.

(c) Criteria. An order under this

section may be entered only if the court

determines that good cause exists. To

make this determination the court must

find:

(1) There is reason to believe that an

employee or agent of a VA treatment

program is engaged in criminal activity;

(2) Other ways of obtaining evidence

of this criminal activity are not available

or would not be effective; and

(3) The public interest and need for

the placement of an undercover agent or

informant in the VA treatment program

outweigh the potential injury to patients

of the program, physician-patient

relationships and the treatment services.

(d) Content of order. An order

authorizing the placement of an

undercover agent or informant in a VA

treatment program must:

(1) Specifically authorize the

placement of an undercover agent or an

informant;

(2) Limit the total period of the

placement to six months;

(3) Prohibit the undercover agent or

informant from disclosing any patient

identifying information obtained from

the placement except as necessary to

criminally investigate or prosecute

employees or agents of the VA treatment

program; and

(4) Include any other measures which

are appropriate to limit any potential

disruption of the program by the

placement and any potential for a real

or apparent breach of patient

confidentiality; for example, sealing

from public scrutiny the record of any

proceeding for which disclosure of a

patient’s record has been ordered.

(e) Limitation on use of information.

No information obtained by an

undercover agent or informant placed

under this section may be used to

criminally investigate or prosecute any

patient or as the basis for an application

for an order under § 1.494 of this part.

(Authority: 38 U.S.C. 7334)

§ 1.497–1.499 [Reserved]

§ 1.513 [Amended]

3. In § 1.513(b)(2) remove the words

‘‘Post Office Department’’ and add in

their place, ‘‘U.S. Postal Service’’.

§ 1.513a [Removed]

4. Section § 1.513a is removed.

[FR Doc. 95–30138 Filed 12–12–95; 8:45 am]

BILLING CODE 8320–01–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[PA 081–4012a; FRL–5326–5]

Approval and Promulgation of Air

Quality Implementation Plans;

Pennsylvania; Approval of Stage II

Vapor Recovery Requirements

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: EPA is approving a State

Implementation Plan (SIP) revision

submitted by the Commonwealth of

Pennsylvania. This revision

supplements the approved Pennsylvania

Stage II regulation by establishing and

requiring appropriate testing and

certification of Stage II vapor recovery

equipment for affected sources in

Pennsylvania. The intended effect of

this action is to approve these

requirements as a supplement to the

Pennsylvania Stage II vapor recovery

regulation, Chapter 129.82. Final

approval of these supplemental

provisions to the Stage II regulation will

stop the sanctions clock that was started

on June 13, 1994.

DATES: This action will become effective

January 22, 1996 unless notice is

received on or before January 12, 1996

that adverse or critical comments will

be submitted. If the effective date is

delayed, timely notice will be published

in the Federal Register.

ADDRESSES: Comments may be mailed to

Marcia L. Spink, Associate Director, Air

Programs, Mailcode 3AT00, U.S.

Environmental Protection Agency,

Region III, 841 Chestnut Building,

Philadelphia, Pennsylvania 19107.

Copies of the documents relevant to this

action are available for public

inspection during normal business

hours at the Air, Radiation, and Toxics

Division, U.S. Environmental Protection

Agency, Region III, 841 Chestnut

Building, Philadelphia, Pennsylvania

19107; the Air and Radiation Docket

and Information Center, U.S.

Environmental Protection Agency, 401

M Street, SW, Washington, DC 20460;

Pennsylvania Department of

Environmental Protection, Bureau of Air

Quality, P.O. Box 8468, 400 Market

Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT:

Cynthia H. Stahl, (215) 597–9337, at the

EPA Region III address above.

SUPPLEMENTARY INFORMATION: On

October 26, 1995, the Commonwealth of

Pennsylvania submitted a formal

revision to its State Implementation

Plan (SIP). The SIP revision consists of

sections 6.7(b), (c), (h) and section 17(2)

of the Pennsylvania Air Pollution

Control Act, as amended on June 29,

1992 and effective on July 9, 1992.

These provisions are meant to

supplement the existing Pennsylvania

Stage II vapor recovery regulation,

Chapter 129.82. EPA approved the Stage

II regulations in a final limited

approval/disapproval rulemaking notice

on June 13, 1994 (59 FR 30302). These

supplemental provisions correct the

deficiencies identified in that

rulemaking notice and the proposal,

which was published on November 29,

1993 (58 FR 62560). The June 13, 1994

final limited approval/disapproval

rulemaking started a sanctions clock

that allowed Pennsylvania 18 months to

submit material that would correct the

deficiencies in the Stage II regulation.

This 18 month period ends on January

14, 1996. Final approval of the Stage II

regulations will stop this sanctions

clock. The submittal of the

supplemental provisions that correct the

existing deficiency in the Pennsylvania

Stage II regulation allows EPA to

convert the limited approval/

disapproval of the Pennsylvania Stage II

regulation to a full approval; thereby

halting the sanctions clock.

Summary of SIP Revision

Section 17(2) establishes the effective

date of the Pennsylvania Stage II vapor

recovery regulations as November 12,

1992. This effective date is consistent

with the requirements of section 182 of