[Federal Register Volume 59, Number 159 (Thursday, August 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20226]


[[Page Unknown]]

[Federal Register: August 18, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

42 CFR Part 2

RIN 0905-AD97

 

Alcohol and Drug Abuse Patient Records

AGENCY: Substance Abuse and Mental Health Services Administration, PHS, 
HHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Department is proposing a clarification to the regulations 
which govern the confidentiality of alcohol and drug abuse records. 
Specifically, the Department is proposing to clarify that, as to 
general medical care facilities, these regulations 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.

DATES: Written comments must be received on or before October 17, 1994.

ADDRESSES: Written comments on these proposed rules may be sent to Sue 
Martone, SAMHSA, Room 12C15, 5600 Fishers Lane, Rockville, Maryland 
20857.

FOR FURTHER INFORMATION: Sue Martone, Telephone (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, Public Law 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).

    The purpose of this notice is 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 Sec. 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.
    The Department believes this interpretation too broadly defines the 
term ``program.'' It is the Department's position that ``program'' 
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 (3) 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.
    This was the intent of the revisions made to the regulations in 
1987. See 52 FR 21796, 21797 (June 9, 1987). 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.
    Accordingly, as to general medical facilities, it is the 
Department's position that the regulations apply only to discrete, 
identifiable units providing alcohol or drug abuse treatment, diagnosis 
or referral for treatment or specialized personnel who are identified 
as providing such services as a primary function. By way of example, 
these regulations do not apply to alcohol or drug abuse prevention 
programs, whether based in general care facilities or otherwise, which 
do not hold themselves out to the community as providing alcohol or 
drug abuse diagnosis, treatment or referral for treatment, even though 
such programs may occasionally refer individuals to treatment for 
substance abuse as an incidental function of the prevention program. 
Nor do they apply to emergency room personnel who may treat substance 
abusers who need medical attention, unless the provision of alcohol and 
drug abuse diagnosis, treatment or referral for treatment is the 
primary function of such staff and they have been identified as 
providing such services, or the emergency room as a whole has promoted 
itself to the community as providing such services. Finally, these 
regulations do not apply to physicians or other medical personnel in a 
general medical facility who are not identified as providing such 
services even though they may occasionally provide drug abuse services, 
such as referral.
    These regulations do, however, apply to federally assisted 
specialized drug and alcohol treatment units in general medical 
facilities and to identified personnel whose primary function is the 
provision of such services. For example, although the regulations would 
not ordinarily apply to a staff physician of an emergency room or an 
intensive care unit who refers an overdose patient to a drug abuse 
treatment practitioner, they would apply to a drug abuse treatment 
practitioner whose primary function is to provide such services.
    This notice would also update the authority citation to reflect 
that 42 U.S.C. 290dd-3 and 290ee-3 were amended by section 131 of the 
ADAMHA Reorganization Act, Public Law 102-321 (July 10, 1992), 42 
U.S.C. 290dd-2.

Executive Order 12866

    Executive Order 12866 requires that all regulatory actions reflect 
consideration of the costs and benefits they generate, and that they 
meet certain standards, such as avoiding the imposition of unnecessary 
burdens on the affected public. If a regulatory action is deemed to 
fall within the scope of the definition of the term ``significant 
regulatory action'' contained in section 3(f) of the Order, pre-
publication review by the Office of Management and Budget's Office of 
Information and Regulatory Affairs (OIRA) is necessary. OIRA has thus 
reviewed this NPRM under the Order.

Regulatory Flexibility Act

    The Regulatory Flexibility Act of 1980 requires that we analyze 
regulatory proposals to determine whether they create a significant 
impact on a substantial number of small entities. The Secretary 
certifies that any final rule resulting from this proposal will not 
have any such impact.

Paperwork Reduction Act

    There are no paperwork requirements in this proposal subject to 
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: March 16, 1994.
Philip R. Lee,
Assistant Secretary for Health.

    Approved: June 27, 1994.
Donna E. Shalala,
Secretary.

    For the reasons set out in the preamble, the Department proposes to 
amend part 2 of title 42, Code of Federal Regulations, 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-1).


Sec. 2.11  [Amended]

    2. In Section 2.11, the definition of Program is revised to read as 
follows:
* * * * *
    Program means:
    (1) 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
    (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
    (3) 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 example).
* * * * *


Sec. 2.12  [Amended]

    3. Section 2.12(e)(1) is amended by adding the following sentence 
at the end to read as follows:
* * * * *
    (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. 94-20226 Filed 8-17-94; 8:45 am]
BILLING CODE 4160-20-M