[Federal Register Volume 60, Number 87 (Friday, May 5, 1995)]
[Rules and Regulations]
[Pages 22296-22297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10860]



=======================================================================
-----------------------------------------------------------------------

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. 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]
BILLING CODE 4120-20-M