[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
