22296 Federal Register / Vol. 60, No. 87 / Friday, May 5, 1995 / Rules and Regulations

[FR Doc. 95–10972 Filed 5–4–95; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

42 CFR Part 2

Substance Abuse and Mental Health

Services Administration;

Confidentiality of Alcohol and Drug

Abuse Patient Records

RIN: 0905–AD97

AGENCY: Substance Abuse and Mental

Health Services Administration, PHS,

HHS.

ACTION: Final rule.

SUMMARY: The Department published a

notice of proposed rulemaking in the

Federal Register at 59 FR 42561 (August

18, 1994) with corresponding

corrections at 59 FR 45063 (August 31,

1994), which proposed a clarification to

the ‘‘Confidentiality of Alcohol and

Drug Abuse Patient Records’’

regulations codified at 42 CFR part 2.

Specifically, the Department proposed

to clarify that, as to general medical care

facilities, these regulations cover only

specialized individuals or units in such

facilities that hold themselves out as

providing and provide alcohol or drug

abuse diagnosis, treatment or referral for

treatment and which are federally

assisted, directly or indirectly. The

Secretary has considered the comments

received during the comment period,

and is amending the regulations.

EFFECTIVE DATE: June 5, 1995.

FOR FURTHER INFORMATION CONTACT:

Sue Martone, SAMHSA, Room 12C15,

5600 Fishers Lane, Rockville, Maryland

20857, tel. (301) 443–4640.

SUPPLEMENTARY INFORMATION: The

‘‘Confidentiality of Alcohol and Drug

Abuse Patient Records’’ regulations, 42

CFR part 2, implement section 543 of

the Public Health Service Act, 42 U.S.C.

§ 290dd–2, as amended by section 131

of the ADAMHA Reorganization Act,

Pub. L. 102–321 (July 10, 1992). The

regulations were promulgated as a final

rule on July 1, 1975 (40 FR 27802) and

amended on June 9,1987 (52 FR 21798).

After considering the comments, the

Department is revising the regulations to

clarify the definition of ‘‘program.’’

Background of the Interim Final Rule

and Summary of and Responses to

Public Comments

A. Notice of Proposed Rulemaking

The notice of proposed rulemaking

published at 59 FR 42561 (August 18,

19940 proposed to revise 42 CFR part 2

to clarify the ambiguity in the

regulations regarding the definition of

‘‘program.’’ This ambiguity was

identified in the case United States v.

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

1989), where the court held that the

Veterans Administration Medical

Center’s (VAMC) general emergency

room is a ‘‘program’’ as defined by the

regulations. In reaching this conclusion,

the court relied on the clause that

‘‘[p]rogram means a person which in

whole or in part holds itself out as

providing, and provides, alcohol or drug

abuse diagnosis, treatment, or referral

for treatment.’’ Id. The court ruled that

the VAMC was a ‘‘person’’ which is

defined at section 2.12 to mean ‘‘an

individual, * * * Federal, State or local

government or any other legal entity,’’

and concluded that ‘‘[a] hospital

emergency room, while obviously also

performing functions unrelated to drug

abuse, serves as a vital first link in drug

abuse diagnosis, treatment and referral.’’

Id.

As indicated in the NPRM, the

Department believed this interpretation

too broadly defined the term ‘‘program’’

in the regulations. See 59 FR 42561,

42562. Accordingly, the Department

proposed to clarify the definition of

‘‘program’’ in the regulations to ensure

that it encompasses only (1) an

individual or entity (other than a

general medical facility) who holds

itself out as providing, and provides,

alcohol or drug abuse diagnosis,

treatment or referral for treatment; or (2)

an identified unit within a general

medical facility which holds itself out

as providing, and provides, alcohol or

drug abuse diagnosis, treatment or

referral for treatment; or 93) 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.

B. Public Comments

Two commenters believed that the

revised definition of ‘‘program’’ was too

narrow. One of these commenters

believed that the definition of

‘‘program’’ should include all

physicians and other hospital and

emergency room personnel who treat

substance abusers. The other commenter

believed that emergency room personnel

should be covered by the regulations

because they serve as an important

source of referrals for substance abuse

treatment. Both commenters believed

that relief from the confidentiality rules

could discourage persons who abuse

substances from seeking services for

other medical problems.

It should be noted that the

clarification which was proposed was

the intent of the revisions made to the

regulations in 1987. See 52 FR 21796,

21797 (June 9, 1987). As indicated in

the NPRM, prior to the 1987

amendments, the regulations applied to

any record relating to substance abuse

whether the information was obtained

from an emergency room, a general

medical unit or a general practitioner so

long as there was a Federal nexus. In

1987, however, it was the intent of the

Department to limit the applicability of

the regulations to specialized programs

and personnel so as to simplify

administration of the regulations. It was

the Department’s position that this

limitation would not significantly affect

the incentive to seek treatment provided

by the confidentiality protection. See 52

FR at 21797. Furthermore, the

Department questioned whether

applicability of the regulations to

general medical care facilities addressed

the intent of Congress to enhance

treatment incentives for alcohol and

drug abuse, since many substance abuse

patients are treated in a general medical

care facility not because they have made

a decision to seek substance abuse

treatment, but because they have

suffered a trauma or have an acute

condition with a primary diagnosis of

something other than substance abuse.

Id.

The Department is not aware of any

evidence that the narrowing of the

applicability of the regulations in 1987

(at least for jurisdictions other than the

Ninth Circuit) has adversely affected

substance abusers from seeking

treatment whether for substance abuse

or other medical problems. The

Department is also not persuaded that

encompassing all health care facilities

and providers who provide alcohol and

drug abuse treatment only as an

incident to the provision of general

medical care is warranted in light of the

economic impact such a regulation

would have on a substantial number of

facilities which do not specialize in

substance abuse treatment, referral or

diagnosis.

One Federal agency believed that the

proposed definition of ‘‘program’’ does

not provide sufficient guidance to law

enforcement, particularly the phrase

‘‘holds itself out as * * *.’’ That agency

believed that the definition presents an

opportunity for a practitioner who does

not engage in substance treatment or

referral for treatment, to designate

himself or herself as a ‘‘program,’’

thereby avoiding regulatory or

investigative scrutiny.
Federal Register / Vol. 60, No. 87 / Friday, May 5, 1995 / Rules and Regulations 22297

It should be noted that, in the

definition of a ‘‘program,’’ a private

sector practitioner must not only hold

himself or herself out as providing such

treatment, referral or diagnosis, but also

must provide such treatment, referral or

diagnosis. Therefore, even though a

person may hold himself or herself out

as providing substance abuse treatment,

diagnosis or referral, that person would

not constitute a program if he or she

does not provide such treatment,

diagnosis or referral.

It should also be noted that, even if

the regulations do apply, the regulations

do not bar investigative or regulatory

scrutiny of such programs. Law

enforcement agents may obtain a court

order to place an undercover agent in a

program, 42 CFR 2.67, or a court order

directing a program to disclose patient

identifying information for use of

records to investigate or prosecute a

program, 42 CFR 2.66.

This Federal agency also requested

that the Department provide more

guidance to law enforcement on the

phrase ‘‘holds itself out as’’ so as to

enable them to determine whether an

investigation of a particular practitioner

via patient records or undercover

operations would require a court order.

This agency suggested that the

Department require private practitioners

who provide such treatment, diagnosis

or referral to indicate this through, for

example, state licensing procedures,

advertising or the posting of notice in

their offices.

The Department believes that private

practitioners may hold themselves out

as providing substance abuse treatment,

diagnosis or referral by the means

described above. However, the primary

purpose of the statute is to protect the

confidentiality of alcohol and drug

abuse patient records. The Department

does not believe that requiring all

programs to, for example, post notice in

some conspicuous place (stating that

they were subject to these regulations) is

meaningful, since it does not necessarily

mean that the regulations would not be

applicable if such signs were not posted.

Given their questionable value, such

requirements would place an

unnecessary burden on programs.

Furthermore, federally assisted

programs are to inform law enforcement

officials who are seeking records that

they are covered by the regulations and

cannot provide patient records without

a court order, thus placing such officials

on notice.

Finally, although the law and the

implementing regulations require that

law enforcement officials take

additional measures to obtain certain

information (i.e., court orders to obtain

patient records or to place an

undercover agent in a program), the

Department believes that the narrowing

of these regulations to specialized

programs and practitioners should make

it easier for such officials to identify

‘‘programs’’ to who these regulations are

applicable and, thus, to obtain the

relevant court orders.

Economic Impact

This rule does not have cost

implications for the economy of $100

million or otherwise meet the criteria

for a major rule under Executive Order

12291, and therefore do not require a

regulation impact analysis. Further,

these regulations will not have a

significant impact on a substantial

number of small entities, and therefore

do not require a regulatory flexibility

analysis under the Regulatory

Flexibility Act of 1980.

Federal Supremacy

These regulations are not intended to

preempt the field of law which they

cover to the exclusion of all State laws

in that field. However, consistent with

established principles of constitutional

law, the Federal regulations will

supersede State law to the extent that

there is a conflict. See 42 CFR 2.20 for

further discussion of the relationship

between these regulations and State

laws.

Paperwork Reduction Act

There are no new paperwork

requirements subject to the Office of

Management and Budget approval

under the Paperwork Reduction Act of

1980.

List of Subjects in 42 CFR Part 2

Alcohol abuse, alcoholism,

Confidentiality, Drug abuse, Health

records, Privacy.

Dated: February 14, 1995.

Philip R. Lee,

Assistant Secretary for Health.

Approved: March 22, 1995.

Donna E. Shalala,

Secretary.

For the reasons set out in the

preamble, part 2 of title 42, Code of

Federal Regulations, is amended as

follows:

PART 2—[AMENDED]

1. The authority citation for part 2 is

revised to read as follows:

Authority: Sec. 408 of Pub. L. 92–255, 86

Stat. 79, as amended by sec. 303 (a), (b) of

Pub L. 93–282, 83 Stat. 137, 138; sec.

4(c)(5)(A) of Pub. L. 94–237, 90 Stat. 244; sec.

111(c)(3) of Pub. L. 94–581, 90 Stat. 2852;

sec. 509 of Pub. L. 96–88, 93 Stat. 695; sec.

973(d) of Pub. L. 97–35, 95 Stat. 598; and

transferred to sec. 527 of the Public Health

Service Act by sec. 2(b)(16)(B) of Pub. L. 98–

24, 97 Stat. 182 and as amended by sec. 106

of Pub. L. 99–401, 100 Stat. 907 (42 U.S.C.

290ee–3) and sec. 333 of Pub. L. 91–616, 84

Stat. 1853, as amended by sec. 122(a) of Pub.

L. 93–282, 88 Stat. 131; and sec. 111(c)(4) of

Pub. L. 94–581, 90 Stat. 2852 and transferred

to sec. 523 of the Public Health Service Act

by sec. 2(b)(13) of Pub. L. 98–24, 97 Stat. 181

and as amended by sec. 106 of Pub. L. 99–

401, 100 Stat. 907 (42 U.S.C. 290dd–3), as

amended by sec. 131 of Pub. L. 102–321, 106

Stat. 368, (42 U.S.C. 290dd–2).

2. In § 2.11, the definition of Program

is revised to read as follows:

§ 2.11 Definitions.

* * * * *

Program means:

(a) An individual or entity (other than

a general medical care facility) who

holds itself out as providing, and

provides, alcohol or drug abuse

diagnosis, treatment or referral for

treatment; or

(b) An identified unit within a general

medical facility which holds itself out

as providing, and provides, alcohol or

drug abuse diagnosis, treatment or

referral for treatment; or

(c) 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.

(See § 2.12(e)(1) for examples.)

* * * * *

3. Section 2.12(e)(1) is amended by

adding the following sentence at the end

to read as follows:

§ 2.12 Applicability.

* * * * *

(e) * * * (1) * * * However, these

regulations would not apply, for

example, to emergency room personnel

who refer a patient to the intensive care

unit for an apparent overdose, unless

the primary function of such personnel

is the provision of alcohol or drug abuse

diagnosis, treatment or referral and they

are identified as providing such services

or the emergency room has promoted

itself to the community as a provider of

such services.

* * * * *

[FR Doc. 95–10860 Filed 5–4–95; 8:45 am]

BILLING CODE 4120–20–M