81 FR 51836 - Release of VA Records Relating to HIV

DEPARTMENT OF VETERANS AFFAIRS

Federal Register Volume 81, Issue 151 (August 5, 2016)

Page Range		51836-51838
FR Document		2016-18660
The Department of Veterans Affairs (VA) proposes to amend its medical regulations governing the release of VA medical records. Specifically, VA proposes to eliminate the restriction on protecting a negative test result for the human immunodeficiency virus (HIV). HIV testing is a common practice today in healthcare and the stigma of testing that may have been seen in the 1980s when HIV was first discovered is no longer prevalent. Continuing to protect negative HIV tests causes delays and an unnecessary burden to veterans when VA tries to share electronic medical information with the veterans' outside providers for their treatment through health information exchange efforts. For this same reason, VA would also eliminate negative test results of sickle cell anemia as protected medical information. This proposed rule would eliminate the current barriers to electronic medical information exchange.
Federal Register, Volume 81 Issue 151 (Friday, August 5, 2016)
[Federal Register Volume 81, Number 151 (Friday, August 5, 2016)]
[Proposed Rules]
[Pages 51836-51838]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18660]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AP73


Release of VA Records Relating to HIV

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Department of Veterans Affairs (VA) proposes to amend its 
medical regulations governing the release of VA medical records. 
Specifically, VA proposes to eliminate the restriction on protecting a 
negative test result for the human immunodeficiency virus (HIV). HIV 
testing is a common practice today in healthcare and the stigma of 
testing that may have been seen in the 1980s when HIV was first 
discovered is no longer prevalent. Continuing to protect negative HIV 
tests causes delays and an unnecessary burden to veterans when VA tries 
to share electronic medical information with the veterans' outside 
providers for their treatment through health information exchange 
efforts. For this same reason, VA would also eliminate negative test 
results of sickle cell anemia as protected medical information. This 
proposed rule would eliminate the current barriers to electronic 
medical information exchange.

DATES: Comments must be received on or before October 4, 2016.

ADDRESSES: Written comments may be submitted through 
www.Regulations.gov; by mail or hand-delivery to Director, Regulation 
Policy and Management (00REG), Department of Veterans Affairs, 810 
Vermont Avenue NW., Room 1068, Washington, DC 20420; or by fax to (202) 
273-9026. Comments should indicate that they are submitted in response 
to ``RIN 2900-AP73--Release of VA Records Relating to HIV.'' Copies of 
comments received will be available for public inspection in the Office 
of Regulation Policy and Management, Room 1068, between the hours of 8 
a.m. and 4:30 p.m., Monday through Friday (except holidays). Please 
call (202) 461-4902 for an appointment. (This is not a toll-free 
number.) In addition, during the comment period, comments may be viewed 
online through the Federal Docket Management System at 
www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Stephania H. Griffin, Director, 
Information Access and Privacy Office (10P2C), Department of Veterans 
Affairs, 810 Vermont Avenue NW., Washington, DC 20420; (704) 245-2492. 
(This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: The Veterans Omnibus Health Care Act of 
1976, Public Law 94-581, codified at 38 U.S.C. 7332, ensured 
confidentiality of medical records relating to drug abuse, alcoholism, 
and sickle cell anemia by establishing sanctions for unauthorized 
disclosure of information while meeting the legitimate needs for 
disclosure under certain conditions. In 1988, Public Law 100-322 added 
to this list the confidentiality of medical records relating to 
infection with the human immunodeficiency virus (HIV). Section 7332 
states that records of the identity, diagnosis, prognosis, or treatment 
of any patient or subject which are maintained in connection with the 
performance of any program or activity (including education, training, 
treatment, rehabilitation, or research) of any patient or subject 
relating to drug abuse, alcoholism or alcohol abuse, infection with the 
human immunodeficiency virus (HIV), or sickle cell anemia shall only be 
disclosed under certain circumstances. The intent of section 7332 is to 
protect the medical records of those veterans who are undergoing 
treatment or have a positive diagnosis for the conditions stated in 
this section. Due to the stigma associated with HIV and HIV testing at 
the time, VA determined that the results of HIV testing should be 
protected regardless of the outcome of the test. However, HIV testing 
is common practice today. In the past, VA required health care 
providers to counsel patients as part of the informed consent process 
prior to ordering HIV testing. Currently, HIV testing is considered 
part of routine health care under VA policy, similar to other types of 
diagnostic laboratory testing, and while oral informed consent is still 
required no pre-testing counseling is required.
    The continued protection of negative HIV tests has posed 
significant obstacles to the sharing of medical information between VA 
and non-VA medical providers, and also places an undue burden on 
veterans. If VA conducts an HIV test on a veteran, VA is prevented from 
electronically disclosing the veteran's medical information to the 
veteran's non-VA medical provider, even if the test result is negative, 
unless VA first obtains a specific written authorization that meets 
title 38 regulatory requirements from the veteran to share the medical 
information. Medical information sharing is crucial to treating a 
veteran who has outside medical providers and is significant in making 
certain that a veteran is not prescribed a medication that may 
negatively interact with other medications. Under section 7332, sickle 
cell anemia is also considered protected medical information. As with 
negative HIV test results, the prohibition on sharing negative test 
results for sickle cell anemia has posed challenges for the timely 
provision of medical care. This rulemaking would eliminate the current 
restrictions on sharing negative test results of veterans for HIV and 
sickle cell anemia and would be in line with the intent of the statute. 
As for positive HIV or sickle cell anemia test results, VA would 
continue to require a qualifying written authorization from the veteran 
prior to disclosure of such information.

Section 1.460 Definitions

    Section 1.460 defines terms that apply to Sec. Sec.  1.460 through 
1.499, which cover the release of information from VA records relating 
to drug abuse, alcoholism or alcohol abuse, infection with HIV, or 
sickle cell anemia. The term ``HIV'' is defined as the presence of 
laboratory evidence for human immunodeficiency virus infection. The 
definition for ``HIV'' also states that ``[f]or the purposes of 
Sec. Sec.  1.460 through 1.499 of this part, the term includes the 
testing of an individual for the presence of the virus or antibodies to 
the virus and information related to such testing (including tests with 
negative results).'' We propose to modify this definition because VA 
would only restrict the release of health information for positive 
results. The proposed definition would define ``HIV'' to mean ``the 
presence of laboratory evidence for human immunodeficiency virus 
infection. The term does not include negative results from the testing 
of an individual for the presence of the virus or antibodies to the 
virus, or such testing of an individual where the results are 
negative.'' As previously stated in this rulemaking, negative results 
are not protected under this provision.
    The term ``patient'' is defined in part in Sec.  1.460 to state 
that it includes an individual or subject who is tested for infection 
with HIV or sickle cell anemia. We propose to amend this definition to 
state that the term `patient' for purpose of infection with the human 
immune

[[Page 51837]]

deficiency virus or sickle cell anemia, includes one tested positive 
for the disease even if no treatment is provided. The term does not 
include a patient who has tested negative for the disease. We would 
make this amendment to clarify that VA would only protect the medical 
information of a patient who tested positive for HIV or sickle cell 
anemia and not all individuals who were tested for these diseases. 
Although section 7332 considers sickle cell anemia as protected health 
information, it is silent on the protection of a negative test for 
sickle cell anemia. We would treat an individual who tested negative 
for sickle cell anemia in the same manner as an individual who tested 
negative for HIV. For this same reason, we propose to modify the last 
sentence in the definition of the term ``treatment'' to state the term 
does not include testing for the human immunodeficiency virus or sickle 
cell anemia where the results of such tests are negative. We would also 
amend the definition of ``treatment'' by stating that ``treatment'' 
means the diagnosis, management and care of a patient for infection 
with the human immunodeficiency virus or sickle cell anemia. This 
proposed addition would clarify what VA considers 7332-protected 
medical information.

Section 1.461 Applicability

    Paragraph (a)(1)(i) of 38 CFR 1.461 states the restrictions on 
disclosure of medical information, specifically information that would 
identify a patient as an alcohol or drug abuser, an individual tested 
for or infected with the human immunodeficiency virus (HIV), hereafter 
referred to as HIV, or an individual with sickle cell anemia, either 
directly, by reference to other publicly available information, or 
through verification of such an identification by another person. As 
previously stated in this rulemaking, we would no longer consider 7332-
protected medical information to include a negative test for HIV or 
sickle cell anemia. Therefore, we propose to amend Sec.  1.461(a)(1)(i) 
by removing the restriction on disclosure of medical information for an 
individual who has tested negative for HIV or sickle cell anemia. 
Paragraph (a)(1)(i) would only protect medical information for 
individuals who have tested positive for or are infected with HIV, or 
have tested positive for or have sickle cell anemia.

Effect of Rulemaking

    The Code of Federal Regulations, as proposed to be revised by this 
proposed rulemaking, would represent the exclusive legal authority on 
this subject. No contrary rules or procedures would be authorized. All 
VA guidance would be read to conform with this proposed rulemaking if 
possible or, if not possible, such guidance would be superseded by this 
rulemaking.

Paperwork Reduction Act

    This proposed rule contains no provisions constituting a collection 
of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3521).

Regulatory Flexibility Act

    The Secretary hereby certifies that this proposed 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 proposed rule would directly affect only 
individuals and would not directly affect small entities. Therefore, 
pursuant to 5 U.S.C. 605(b), this rulemaking would be exempt from the 
initial and final regulatory flexibility analysis requirements of 5 
U.S.C. 603 and 604.

Executive Order 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess the 
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 effects, and other advantages; distributive impacts; 
and equity). Executive Order 13563 (Improving Regulation and Regulatory 
Review) emphasizes the importance of quantifying both costs and 
benefits, reducing costs, harmonizing rules, and promoting flexibility. 
Executive Order 12866 (Regulatory Planning and Review) defines a 
``significant regulatory action,'' requiring review by the Office of 
Management and Budget (OMB), unless OMB waives such review, as ``any 
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 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 this Executive Order.''
    The economic, interagency, budgetary, legal, and policy 
implications of this regulatory action have been examined, and it has 
been determined not to be a significant regulatory action under 
Executive Order 12866. VA's impact analysis can be found as a 
supporting document at http://www.regulations.gov, usually within 48 
hours after the rulemaking document is published. Additionally, a copy 
of the rulemaking and its impact analysis are available on VA's Web 
site at http://www.va.gov/orpm/, by following the link for ``VA 
Regulations Published From FY 2004 Through Fiscal Year to Date.''

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 the 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 one year. This proposed rule would have no such 
effect on State, local, and tribal governments, or on the private 
sector.

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for 
the programs affected by this document are 64.007, Blind Rehabilitation 
Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical 
Care Benefits; 64.010, Veterans Nursing Home Care; 64.011, Veterans 
Dental Care; 64.012, Veterans Prescription Service; 64.014, Veterans 
State Domiciliary Care; 64.015, Veterans State Nursing Home Care; 
64.018, Sharing Specialized Medical Resources; 64.019, Veterans 
Rehabilitation Alcohol and Drug Dependence; 64.022, Veterans Home Based 
Primary Care; and 64.024, VA Homeless Providers Grant and Per Diem 
Program.

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. Gina S. 
Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, 
approved this document on August 1, 2016, for publication.

[[Page 51838]]

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, 
Postal Service, Privacy, Reporting and recordkeeping requirements, 
Seals and insignia, Security measures, Wages.

    Dated: August 2, 2016.
Janet J. Coleman,
Chief, Office of Regulation Policy & Management, Office of the 
Secretary, Department of Veterans Affairs.

    For the reasons set out in the preamble, Department of Veterans 
Affairs proposes to amend 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:
0
a. Revising the last sentence of the definition of ``Infection with the 
human immunodeficiency virus (HIV).''
0
b. Revising the definition of ``Patient.''
0
c. Revising the definition of ``Treatment.''
    The revisions read as follows:


Sec.  1.460  Definitions.

* * * * *
    Infection with the human immunodeficiency virus (HIV). * * * The 
term does not include negative results from the testing of an 
individual for the presence of the virus or antibodies to the virus, or 
such testing of an individual where the results are negative.
* * * * *
    Patient. The term ``patient'' means any individual or subject who 
has been given a diagnosis or treatment for drug abuse, alcoholism or 
alcohol abuse, infection with the human immunodeficiency virus, or 
sickle cell anemia and includes any individual who, after arrest on a 
criminal charge, is interviewed and/or tested in connection with drug 
abuse, alcoholism or alcohol abuse, infection with the human 
immunodeficiency virus, or sickle cell anemia in order to determine 
that individual's eligibility to participate in a treatment or 
rehabilitation program if the result of such testing is positive. The 
term ``patient'' includes an individual who has been diagnosed or 
treated for alcoholism, drug abuse, HIV infection, or sickle cell 
anemia for purposes of participation in a VA program or activity 
relating to those four conditions, including a program or activity 
consisting of treatment, rehabilitation, education, training, 
evaluation, or research. For the purpose of infection with the human 
immunodeficiency virus or sickle cell anemia, the term ``patient'' 
includes one tested positive for the disease even if no treatment is 
provided, offered, or requested. The term does not include a patient 
who has tested negative for the disease.
* * * * *
    Treatment. The term ``treatment'' means the management and care of 
a patient for drug abuse, alcoholism or alcohol abuse, or the 
diagnosis, management and care of a patient for infection with the 
human immunodeficiency virus, or sickle cell anemia, or a condition 
which is identified as having been caused by one or more of these 
conditions, in order to reduce or eliminate the adverse effects upon 
the patient. The term does not include negative test results for the 
human immunodeficiency virus, antibodies to the virus, or sickle cell 
anemia, or such testing of an individual where the results are 
negative.''
* * * * *
0
3. Revising Sec.  1.461(a)(1)(i) to read as follows.


Sec.  1.461  Applicability.

    (a) * * *
    (1) * * *
    (i) Would identify a patient as an alcohol or drug abuser, an 
individual who tested positive for or is infected with the human 
immunodeficiency virus (HIV), hereafter referred to as HIV, or an 
individual who tested positive for or has sickle cell anemia, either 
directly, by reference to other publicly available information, or 
through verification of such an identification by another person; and
* * * * *
[FR Doc. 2016-18660 Filed 8-4-16; 8:45 am]
BILLING CODE 8320-01-P
Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Proposed Rules 51837

deficiency virus or sickle cell anemia, No contrary rules or procedures would the principles set forth in this Executive
includes one tested positive for the be authorized. All VA guidance would Order.’’
disease even if no treatment is provided. be read to conform with this proposed The economic, interagency,
The term does not include a patient who rulemaking if possible or, if not budgetary, legal, and policy
has tested negative for the disease. We possible, such guidance would be implications of this regulatory action
would make this amendment to clarify superseded by this rulemaking. have been examined, and it has been
that VA would only protect the medical determined not to be a significant
Paperwork Reduction Act
information of a patient who tested regulatory action under Executive Order
positive for HIV or sickle cell anemia This proposed rule contains no
provisions constituting a collection of 12866. VA’s impact analysis can be
and not all individuals who were tested found as a supporting document at
for these diseases. Although section information under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501– http://www.regulations.gov, usually
7332 considers sickle cell anemia as within 48 hours after the rulemaking
protected health information, it is silent 3521).
document is published. Additionally, a
on the protection of a negative test for Regulatory Flexibility Act copy of the rulemaking and its impact
sickle cell anemia. We would treat an
The Secretary hereby certifies that analysis are available on VA’s Web site
individual who tested negative for
this proposed rule would not have a at http://www.va.gov/orpm/, by
sickle cell anemia in the same manner
significant economic impact on a following the link for ‘‘VA Regulations
as an individual who tested negative for
substantial number of small entities as Published From FY 2004 Through Fiscal
HIV. For this same reason, we propose
they are defined in the Regulatory Year to Date.’’
to modify the last sentence in the
definition of the term ‘‘treatment’’ to Flexibility Act, 5 U.S.C. 601–612. This Unfunded Mandates
state the term does not include testing proposed rule would directly affect only
for the human immunodeficiency virus individuals and would not directly The Unfunded Mandates Reform Act
or sickle cell anemia where the results affect small entities. Therefore, pursuant of 1995 requires, at 2 U.S.C. 1532, that
of such tests are negative. We would to 5 U.S.C. 605(b), this rulemaking agencies prepare an assessment of
also amend the definition of would be exempt from the initial and anticipated costs and benefits before
‘‘treatment’’ by stating that ‘‘treatment’’ final regulatory flexibility analysis issuing any rule that may result in the
means the diagnosis, management and requirements of 5 U.S.C. 603 and 604. expenditure by State, local, and tribal
care of a patient for infection with the Executive Order 12866 and 13563 governments, in the aggregate, or by the
human immunodeficiency virus or private sector, of $100 million or more
Executive Orders 12866 and 13563 (adjusted annually for inflation) in any
sickle cell anemia. This proposed
direct agencies to assess the costs and one year. This proposed rule would
addition would clarify what VA
benefits of available regulatory have no such effect on State, local, and
considers 7332-protected medical
alternatives and, when regulation is tribal governments, or on the private
information.
necessary, to select regulatory sector.
Section 1.461 Applicability approaches that maximize net benefits
Paragraph (a)(1)(i) of 38 CFR 1.461 (including potential economic, Catalog of Federal Domestic Assistance
states the restrictions on disclosure of environmental, public health and safety
effects, and other advantages; The Catalog of Federal Domestic
medical information, specifically Assistance numbers and titles for the
information that would identify a distributive impacts; and equity).
Executive Order 13563 (Improving programs affected by this document are
patient as an alcohol or drug abuser, an
Regulation and Regulatory Review) 64.007, Blind Rehabilitation Centers;
individual tested for or infected with
emphasizes the importance of 64.008, Veterans Domiciliary Care;
the human immunodeficiency virus
quantifying both costs and benefits, 64.009, Veterans Medical Care Benefits;
(HIV), hereafter referred to as HIV, or an
reducing costs, harmonizing rules, and 64.010, Veterans Nursing Home Care;
individual with sickle cell anemia,
promoting flexibility. Executive Order 64.011, Veterans Dental Care; 64.012,
either directly, by reference to other
12866 (Regulatory Planning and Veterans Prescription Service; 64.014,
publicly available information, or
Review) defines a ‘‘significant Veterans State Domiciliary Care; 64.015,
through verification of such an
regulatory action,’’ requiring review by Veterans State Nursing Home Care;
identification by another person. As
the Office of Management and Budget 64.018, Sharing Specialized Medical
previously stated in this rulemaking, we
(OMB), unless OMB waives such Resources; 64.019, Veterans
would no longer consider 7332-
review, as ‘‘any regulatory action that is Rehabilitation Alcohol and Drug
protected medical information to
likely to result in a rule that may: (1) Dependence; 64.022, Veterans Home
include a negative test for HIV or sickle
Have an annual effect on the economy Based Primary Care; and 64.024, VA
cell anemia. Therefore, we propose to
of $100 million or more or adversely Homeless Providers Grant and Per Diem
amend § 1.461(a)(1)(i) by removing the
affect in a material way the economy, a Program.
restriction on disclosure of medical
information for an individual who has sector of the economy, productivity, Signing Authority
tested negative for HIV or sickle cell competition, jobs, the environment,
anemia. Paragraph (a)(1)(i) would only public health or safety, or State, local, The Secretary of Veterans Affairs, or
protect medical information for or tribal governments or communities; designee, approved this document and
individuals who have tested positive for (2) Create a serious inconsistency or authorized the undersigned to sign and
mstockstill on DSK3G9T082PROD with PROPOSALS

or are infected with HIV, or have tested otherwise interfere with an action taken submit the document to the Office of the
positive for or have sickle cell anemia. or planned by another agency; (3) Federal Register for publication
Materially alter the budgetary impact of electronically as an official document of
Effect of Rulemaking entitlements, grants, user fees, or loan the Department of Veterans Affairs. Gina
The Code of Federal Regulations, as programs or the rights and obligations of S. Farrisee, Deputy Chief of Staff,
proposed to be revised by this proposed recipients thereof; or (4) Raise novel Department of Veterans Affairs,
rulemaking, would represent the legal or policy issues arising out of legal approved this document on August 1,
exclusive legal authority on this subject. mandates, the President’s priorities, or 2016, for publication.

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Document Created: 2016-08-05 06:43:32
Document Modified: 2016-08-05 06:43:32
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Proposed rule.
Dates		Comments must be received on or before October 4, 2016.
Contact		Stephania H. Griffin, Director, Information Access and Privacy Office (10P2C), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420; (704) 245-2492. (This is not a toll-free number.)
FR Citation		81 FR 51836
RIN Number		2900-AP73