Substance Abuse and Mental Health Services Administration; Confidentiality of Alcohol and Drug Abuse Patient Records

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.

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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. Sec. 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. [[Page 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 Sec. 2.11, the definition of Program is revised to read as

follows:

Sec. 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 Sec. 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:

Sec. 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]

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