[Federal Register Volume 76, Number 26 (Tuesday, February 8, 2011)]
[Rules and Regulations]
[Pages 6694-6696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-2750]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 1
RIN 2900-AN88
Disclosure of Medical Information to the Surrogate of a Patient
Who Lacks Decision-Making Capacity
AGENCY: Department of Veterans Affairs.
ACTION: Final rule.
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SUMMARY: This document amends Department of Veterans Affairs (VA)
regulations to reflect changes made by section 504 of the Caregivers
and Veterans Omnibus Health Services Act of 2010. Section 504
authorizes a VA practitioner, when the practitioner deems it necessary
to ensure an informed medical decision, to share certain, otherwise
protected medical information with the representative of a patient who
lacks decision-making capacity. This rulemaking amends VA regulations
consistent with this new authority.
DATES: Effective Date: February 8, 2011.
FOR FURTHER INFORMATION CONTACT: Stephania Griffin, Veterans Health
Administration Privacy Officer, Office of Information (19F2), Veterans
Health Administration, Department of Veterans Affairs, 810 Vermont
Ave., NW., Washington, DC 20420, (704) 245-2492 (this is not a toll-
free number).
SUPPLEMENTARY INFORMATION: This document amends VA's regulations
consistent with section 504 of the Caregivers and Veterans Omnibus
[[Page 6695]]
Health Service Act of 2010, Public Law 111-163. The revisions in this
rulemaking restate the new statutory authority so that our regulations
accurately state that practitioners can disclose certain protected
information to a patient's representative under the specified
circumstances. Because the revisions merely restate or interpret
statutory provisions, we have not provided the public with the
opportunity to comment on these changes.
Section 504 of Public Law 111-163 amended 38 U.S.C. 7332(b)(2),
which governs the confidentiality of certain medical records.
Generally, section 7332 bars VA from disclosing the content of any
record of the identity, diagnosis, prognosis, or treatment of patient
that is maintained in connection with any VA program or activity
relating to drug abuse, alcoholism or alcohol abuse, infection with the
human immunodeficiency virus, or sickle cell anemia, without first
obtaining the written consent of the patient. 38 U.S.C. 7332(a)(1),
(b)(1). However, under section 7332(b)(2), VA may disclose such records
``[w]hether or not [the] patient * * * gives written consent'' under
circumstances specified in subparagraphs following subsection (b)(2).
In section 504, Congress added a new subparagraph (b)(2)(F) to 38
U.S.C. 7332, which states that the records may be disclosed without
consent as follows: ``To a representative of a patient who lacks
decision-making capacity, when a practitioner deems the content of the
given record necessary for that representative to make an informed
decision regarding the patient's treatment.''
This rulemaking adds a new regulation, which incorporates the
statutory amendment regarding disclosures to patients' representatives
(38 CFR 1.484), and amends an existing VA regulation to clarify the
meaning of terms used in the new section (38 CFR 1.460).
First, we are amending Sec. 1.460, the regulation that contains
definitions applicable to 38 CFR 1.460 through 1.499, which concern the
confidentiality of information relating to drug abuse, alcoholism or
alcohol abuse, infection with the human immunodeficiency virus, or
sickle cell anemia in VA records and are applicable in combination with
other regulations pertaining to the release of information from VA
records. We are adding definitions of ``decision-making capacity,''
``practitioner,'' and ``surrogate'' to 38 CFR 1.460. These terms appear
only in 38 CFR 1.484, the new section implementing the new statutory
provision; however, we are including them in the general definitions
regulation because we believe that, at some point in the future, the
definitions may be applicable to other disclosure of information
regulations. We want to make sure that the terms will be used
consistently throughout this body of regulations. We are adding these
definitions for purposes of clarification and interpretation only and
intend no substantive change regarding the additional authority granted
by Congress in the amendment to section 7332.
In amended 38 CFR 1.460, ``decision-making capacity'' and
``practitioner'' are defined as ``ha[ving] the same meaning set forth
in 38 CFR 17.32(a).'' This is consistent with the plain language and
intent of 38 U.S.C. 7332(b)(2)(F). The purpose of Sec. 17.32(a) is to
provide definitions in the context of providing informed consent. The
amendment to fnl;38 U.S.C. 7332 likewise is intended to assist a
patient's representative in making ``an informed decision regarding the
patient's treatment.'' Moreover, Sec. 17.32(a) specifically is
authorized by 38 U.S.C. 7331-7334.
Under 38 U.S.C. 7332(b)(2)(F)(i), VA is authorized to release the
identified medical information to a ``representative,'' which is
defined in 38 U.S.C. 7332 (b)(2)(F)(ii) as ``an individual,
organization, or other body authorized under [38 U.S.C. 7331] and its
implementing regulations to give informed consent on behalf of a
patient who lacks decision-making capacity.'' As noted above, 38 CFR
17.32(a) is one such ``implementing regulation[ ].'' Therein, we define
a ``surrogate'' as ``an individual, organization, or other body
authorized under [38 CFR 17.32] to give informed consent on behalf of a
patient who lacks decision-making capacity.'' Because the existing
definition of ``surrogate'' is substantively identical to the statutory
definition of ``representative,'' we interpret ``representative'' as
used by Congress in section 7332(b)(2)(F)(ii) to mean ``surrogate.''
This will promote clarity, cohesiveness, and consistency in our
regulations.
We are adding 38 CFR 1.484 to state, in a regulation, the new
authority provided by 38 U.S.C. 7332(b)(2)(F). The language of the
regulation is derived directly, almost verbatim, from section 7332.
This language is clear on its face and easy for practitioners to apply.
We note that we are not revising 38 CFR 1.465(a), because a ``court
appointed legal guardian'' meets the statutory definition of
``surrogate'' under 38 CFR 1.460 and 17.32(a). We also find it
unnecessary to revise 38 CFR 1.487 through 1.496 because these
regulations authorize disclosure based on authority independent of 38
U.S.C. 7332(b)(2)(F).
Administrative Procedure Act
VA finds, in accordance with 5 U.S.C. 553(b)(A) of the
Administrative Procedure Act (APA), that this final rule merely
incorporates statutory provisions or interprets those provisions.
Therefore, the provisions of the APA regarding notice of proposed
rulemaking and opportunities for public participation are not
applicable. Further, pursuant to section 553(d)(2), this final rule is
exempt from the APA's 30-day delayed effective date requirement.
Unfunded Mandates
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C.
1532, that agencies prepare an assessment of anticipated costs and
benefits before issuing any rule that may result in an expenditure by
state, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million or more (adjusted annually for
inflation) in any given year. This final rule will have no such effect
on state, local, and tribal governments, or on the private sector.
Paperwork Reduction Act
This final rule does not contain any collections of information
under the Paperwork Reduction Act (44 U.S.C. 3501-3520).
Executive Order 12866
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety,
and other advantages; distributive impacts; and equity). The Executive
Order classifies a regulatory action as a ``significant regulatory
action,'' requiring review by the Office of Management and Budget (OMB)
unless OMB waives such review, if it is a regulatory action that is
likely to result in a rule that may: (1) Have an annual effect on the
economy of $100 million or more or adversely affect in a material way
the economy, a sector of the economy, productivity, competition, jobs,
the environment, public health or safety, or state, local, or tribal
governments or communities; (2) create a serious inconsistency or
otherwise interfere with an action taken or planned by another agency;
(3) materially alter the budgetary impact of entitlements, grants, user
fees, or loan programs or the rights and obligations of
[[Page 6696]]
recipients thereof; or (4) raise novel legal or policy issues arising
out of legal mandates, the President's priorities, or the principles
set forth in the Executive Order.
The economic, interagency, budgetary, legal, and policy
implications of this final rule have been examined and it has been
determined not to be a significant regulatory action under Executive
Order 12866.
Regulatory Flexibility Act
The Secretary hereby certifies that this final rule would not have
a significant economic impact on a substantial number of small entities
as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-
612. This final rule affects only VA beneficiaries and their VA
clinicians. Therefore, pursuant to 5 U.S.C. 605(b), this final rule is
exempt from the initial and final regulatory flexibility analysis
requirements of 5 U.S.C. 603 and 604. This final rule is also exempt
from the regulatory flexibility analysis requirements of sections 603
and 604 because it was not preceded by a notice of proposed rulemaking.
Signing Authority
The Secretary of Veterans Affairs, or designee, approved this
document and authorized the undersigned to sign and submit the document
to the Office of the Federal Register for publication electronically as
an official document of the Department of Veterans Affairs. John R.
Gingrich, Chief of Staff, Department of Veterans Affairs, approved this
document on February 2, 2011, for publication.
List of Subjects in 38 CFR Part 1
Administrative practice and procedure, Archives and records,
Cemeteries, Claims, Courts, Crime, Flags, Freedom of Information,
Government contracts, Government employees, Government property,
Infants and children, Inventions and patents, Parking, Penalties,
Privacy, Reporting and recordkeeping requirements, Seals and Insignia,
Security measures, Wages.
Dated: February 3, 2011.
Robert C. McFetridge,
Director, Regulations Policy and Management, Department of Veterans
Affairs.
For the reasons set forth in the preamble, VA amends 38 CFR part 1
as follows:
PART 1--GENERAL PROVISIONS
0
1. The authority citation for part 1 continues to read as follows:
Authority: 38 U.S.C. 501(a), and as noted in specific sections.
0
2. Amend Sec. 1.460 by adding, in alphabetical order, the definitions
of ``decision-making capacity,'' ``practitioner,'' and ``surrogate,''
and by revising the authority citation at the end of the section to
read as follows:
Sec. 1.460 Definitions.
* * * * *
Decision-making capacity. The term ``decision-making capacity'' has
the same meaning set forth in 38 CFR 17.32(a).
* * * * *
Practitioner. The term ``practitioner'' has the same meaning set
forth in 38 CFR 17.32(a).
* * * * *
Surrogate. The term ``surrogate'' has the same meaning set forth in
38 CFR 17.32(a).
* * * * *
(Authority: 38 U.S.C. 7332, 7334)
0
3. Add Sec. 1.484 after the undesignated center heading ``Disclosures
Without Patient Consent'' preceding Sec. 1.485, to read as follows:
Sec. 1.484 Disclosure of medical information to the surrogate of a
patient who lacks decision-making capacity.
A VA medical practitioner may disclose the content of any record of
the identity, diagnosis, prognosis, or treatment of a patient that is
maintained in connection with the performance of any VA program or
activity relating to drug abuse, alcoholism or alcohol abuse, infection
with the human immunodeficiency virus, or sickle cell anemia to a
surrogate of the patient who is the subject of such record if:
(a) The patient lacks decision-making capacity; and
(b) The practitioner deems the content of the given record
necessary for the surrogate to make an informed decision regarding the
patient's treatment.
(Authority: 38 U.S.C. 7331, 7332)
[FR Doc. 2011-2750 Filed 2-7-11; 8:45 am]
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