[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]
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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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