Consent for Release of VA Medical Records, 2762-2765 [2018-00758]
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Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Proposed Rules
necessary under the provisions of the
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37 CFR Part 1
Administrative practice and
procedure, Courts, Freedom of
Information, Inventions and patents,
Reporting and recordkeeping
requirements, Small businesses.
PART 1—RULES OF PRACTICE IN
PATENT CASES
1. The authority citation for part 1
continues to read as follows:
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■
Authority: 35 U.S.C. 2(b)(2).
[Removed and reserved]
2. Section 1.79 is removed and
reserved.
■
[Removed and reserved]
3. Section 1.127 is removed and
reserved.
■
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PART 42—TRIAL PRACTICE BEFORE
THE PATENT TRIAL AND APPEAL
BOARD
5. The authority citation for part 42
continues to read as follows:
■
Authority: 35 U.S.C. 2(b)(2), 6, 21, 23, 41,
135, 311, 312, 316, 321–326 and Public Law
112–29, 125 Stat. 284; and Pub. L. 112–274,
126 Stat. 2456.
§ 42.102
[Amended]
6. Amend § 42.102 by removing and
reserving paragraph (b).
■
§ 42.202
[Amended]
7. Amend § 42.202 by removing and
reserving paragraph (b).
■
Dated: January 11, 2018.
Joseph Matal,
Associate Solicitor, performing the functions
and duties of the Under Secretary of
Commerce for Intellectual Property and
Director of the United States Patent and
Trademark Office.
[FR Doc. 2018–00769 Filed 1–18–18; 8:45 am]
BILLING CODE 3510–16–P
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 1
RIN 2900–AP90
Jkt 244001
Department of Veterans Affairs.
Proposed rule.
AGENCY:
ACTION:
The Department of Veterans
Affairs (VA) proposes to amend its
regulations to clarify that a valid
consent authorizing the Department to
release the patient’s confidential VA
medical records to a health information
exchange (HIE) community partner may
be established not only by VA’s physical
possession of the written consent form,
but also by the HIE community partner’s
written (electronic) attestation that the
patient has, in fact, provided such
consent. This proposed rule would be a
reinterpretation of an existing, longstanding regulation and is necessary to
facilitate modern requirements for the
sharing of patient records with
community health care providers,
health plans, governmental agencies,
and other entities participating in
electronic HIEs. This revision would
ensure that more community health care
providers and other HIE community
partners can deliver informed medical
SUMMARY:
37 CFR Part 42
Administrative practice and
procedure, Inventions and patents.
For the reasons stated in the
preamble, the Office proposes to amend
parts 1 and 42 of title 37 as follows:
§ 1.127
[Removed and reserved]
4. Section 1.351 is removed and
reserved.
■
Consent for Release of VA Medical
Records
List of Subjects
§ 1.79
§ 1.351
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care to patients by having access to the
patient’s VA medical records at the
point of care.
DATES: Comment Date: Comments must
be received on or before March 20, 2018.
ADDRESSES: Written comments may be
submitted through
www.Regulations.gov; by mail or handdelivery to Director, Regulation Policy
and Management (00REG), Department
of Veterans Affairs, 810 Vermont
Avenue NW, Room 1063B, Washington,
DC 20420; or by fax to (202) 273–9026.
Comments should indicate that they are
submitted in response to ‘‘RIN 2900–
AP90 Consent for Release of VA
Medical Records.’’ Copies of comments
received will be available for public
inspection in the Office of Regulation
Policy and Management, Room 1063B,
between the hours of 8:00 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 (FDMS) at
www.Regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Stephania Griffin, Director, Veterans
Health Administration Information
Access and Privacy Office, Department
of Veterans Affairs, 810 Vermont
Avenue NW, Washington, DC 20420;
Stephania.griffin@va.gov, (704) 245–
2492 (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: Under 38
U.S.C. 7332, VA must keep confidential
all records of identity, diagnosis,
prognosis, or treatment of a patient in
connection with any program or activity
carried out by VA related to drug abuse,
alcoholism or alcohol abuse, infection
with human immunodeficiency virus, or
sickle cell anemia, and must obtain
patients’ written consent before VA may
disclose the protected information
unless authorized by the statute. This
requirement applies to communications
between VA and community health care
providers for the purposes of treatment,
except in certain situations, for instance
in medical emergencies and when the
records are sent to a non-Department
entity that provides hospital care to
patients as authorized by the Secretary.
38 U.S.C. 7332(b)(2)(A) and (H); Public
Law 115–26 (April 19, 2017). Although
section 7332 does not explicitly require
that the written consent physically be in
VA’s possession at the time of the
disclosure, VA had interpreted the
statute to require such possession, and
therefore applied 38 CFR 1.475
consistent with that interpretation. VA
has reexamined that statutory
interpretation in light of contemporary
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Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Proposed Rules
healthcare industry standards and
proposes to revise § 1.475 to reflect this
updated reading of section 7332. This
proposed rule would revise 38 CFR
1.475 to permit VA to release section
7332-protected medical records to
eligible community partners, even if VA
does not physically have the patient’s
written consent, provided that specified
criteria are met.
The ability to quickly release section
7332-protected information has become
increasingly important as VA strives to
support veterans’ choice to seek care in
the community and create innovative
ways to provide effective and timely
care to veterans. In this regard, VA has
entered into an agreement to participate
in an HIE to help facilitate the transfer
of information between different
organizations. An HIE is the electronic
transfer of health information among
organizations according to nationally
recognized standards. The organizations
that participate (HIE community
partners) range from community health
care providers and health plans to
governmental agencies providing
benefits, such as the Social Security
Administration (SSA).
The interpretation that valid consent
may be established only by VA’s
physical possession of the written
consent has left many HIE community
partners unable to access veterans’ VA
medical records at the point of care.
While an estimated three out of four
veterans enrolled in VA’s health care
system also seek medical care in the
community, HIE community partners’
requests for their VA health records
must frequently be denied because VA
does not have a consent on file, and
many HIE community partners therefore
either must delay care to veterans or
provide treatment to veterans without
having the benefit of reviewing the
veteran’s full medical history.
The reason for the low rate of consent
is not because veterans object to
providing consent; veteran participation
is almost always favorable when asked
to provide consent. The primary
obstacle is that veterans will often seek
care in the community prior to having
the opportunity to provide the consent
form to VA and are then left without
any means of getting the consent into
VA’s physical possession promptly once
they are at the community health care
facility.
By allowing HIE community partners
to attest that they have, in fact, obtained
a valid consent, VA would be able to
collect consent in a broader array of
circumstances. Most importantly, this
would allow VA to release a veteran’s
medical records to an HIE community
partner, such as a community health
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care provider or SSA, once the partner
attests that they have collected valid
consent, without VA having to wait for
the document to be furnished. This
would allow for HIE community
partners to provide veterans with the
most informed care, would allow VA to
more expediently provide veterans’
records for the adjudication of their SSA
disability claims, and would also allow
for VA to continue innovating and
creating new ways for veterans to
receive timely and high quality health
care.
VA believes that this new
interpretation of section 7332—to
permit disclosure to an HIE community
partner pursuant to the partner’s
attestation regarding written consent,
would uphold veterans’ right to privacy.
As explained in greater detail below,
such disclosure would still require a
legally sufficient written consent. We
clarify that the only change would be
that a valid consent authorizing
disclosure may be established not only
by VA’s physical possession of the
written consent form but also by the HIE
community partner’s attestation that the
veteran has submitted legally sufficient
consent. Moreover, in the private sector
under the Health Insurance Portability
and Accountability Act (HIPAA) Privacy
Rule, health care providers are able to
release a patient’s confidential medical
records to another one of the patient’s
treating providers without written
consent. Therefore, VA’s privacy
protections would remain more robust
than those of the private sector generally
and greater than those required by the
HIPAA Privacy Rule.
This proposed rule would revise 38
CFR 1.460 to include definitions for
‘‘health information exchange’’ and
‘‘health information exchange
community partner’’ as described above.
Further, the rule would revise 1.475 as
follows. Current paragraph (d) would be
redesignated as paragraph (e) and would
be revised as explained below. New
paragraph (d) would provide the criteria
to establish written consent that would
authorize the disclosure of confidential
VA medical records. Specifically, it
would establish that, in addition to
physical possession of a patient’s
written consent, VA may release the
patient’s protected medical information
to an HIE community partner pursuant
to that partner’s attestation that valid
consent has been obtained. To clarify,
this paragraph would not require VA to
provide the records to HIE community
partners just because the partner
submitted an attestation; instead, VA
would have the discretion to send the
records.
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Proposed paragraph (d)(1) states that
written consent may be established by
VA’s physical possession of the
patient’s written consent that meets the
criteria in paragraph (a) of this section.
This is how VA traditionally collected
consent forms.
Paragraph (d)(2) would provide an
alternative for disclosure of section
7332-protected information. VA would
also be able to disclose the protected
information to an HIE community
partner as long as two criteria are met.
Initially, we note that this alternative for
disclosure would be limited to VA’s
partners in the HIE because the partners
have all signed an agreement to comply
with certain standards of practice.
Additionally, all partners would be
required to have the technological
capabilities to provide the requisite
attestation.
The first proposed criterion is that the
HIE community partner must provide
written attestation that the patient has
submitted legally sufficient consent to
them. This requirement is necessary
because 38 U.S.C. 7332 and 38 CFR
1.475 still require the veteran provide
legally sufficient written consent to
release section 7332-protected
information. Therefore, in order for VA
to release the records to the HIE
community partner, VA must have an
attestation or some documentation that
the patient provided legally sufficient
written consent.
To clarify, ‘‘written attestation’’
would not require a physical document
and a wet signature; electronic
attestations satisfy this requirement and
are the expected form of attestation from
the HIE community partner. VA would
not specifically require the attestation to
be electronic in order to provide for
flexibility if there are changes in
technology and best practices. However,
VA envisions the vast majority, if not
all, of the attestations would be
electronic through approved messaging
with the HIE community partners. This
proposed rule would allow for VA’s
community partners to electronically
attest, through the computer software,
that the veteran submitted legally
sufficient written consent. At that time,
VA would be able to release the
veteran’s medical records electronically
to the HIE community partner.
In addition to the written attestation,
paragraph (d)(2) would require that VA
have the ability to retrieve or obtain the
written consent. There are two ways in
which VA can obtain the records. First,
proposed paragraph (d)(2)(i) provides
that a .HIE community partner can make
the consent form available to VA within
10 business days of its attestation. This
can be accomplished either by storing
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Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Proposed Rules
the written consent form electronically
for access by VA or by sending the
written consent form to VA.
Second, paragraph (d)(2)(ii) would
provide that the HIE community partner
can maintain the patient’s written
consent form in accordance with a
memorandum of understanding (MOU)
that is drafted and signed by VA and the
HIE community partner. The MOU
would ensure that the patient’s records
are retained in accordance with VA
record retention requirements set forth
in VHA Records Control Schedule (RCS)
10–1. Even though VA would not
require the written consent to be
physically in VA’s possession since it is
a VA record, the HIE would have to
retain the consent form according to
VA’s record retention requirements.
Paragraph (d)(2)(ii) would also require
that the MOU outline how VA can
request the consent form from the HIE
community partner and how the HIE
community partner can make the
consent form available to VA. In this
regard, VA and the partner would
determine a mutually agreeable
timeframe to comply with a request by
VA for a copy of the consent form.
As explained above current paragraph
(d) would be redesignated as new
paragraph (e). This paragraph would be
revised to update the name of VA Form
10–5345. Specifically, current paragraph
(d) provides that it was not necessary to
use any particular form to establish a
consent referred to in paragraph (a) of
this section, however, VA Form 10–
5345, titled Request for and Consent to
Release of Medical Records Protected by
38 U.S.C. 7332, may be used for such
purpose. VA Form 10–5345 has been
updated and renamed Request for and
Authorization to Release Medical
Records or Health Information.
Accordingly, VA would revise the
paragraph to reflect the new name of VA
Form 10–5345.
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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).
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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). The
overall impact of the proposed rule on
small entities would be minimal as the
proposed rule would only require that
entities attest that they received the
veteran’s consent and make the written
consent available to VA. These
administrative burdens are similar to
current burdens related to medical
privacy and will not have a significant
economic impact on these entities. On
this basis, the Secretary certifies that the
adoption of 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.
Therefore, under 5 U.S.C. 605(b), this
rulemaking is exempt from the initial
and final regulatory flexibility analysis
requirements of sections 603 and 604.
Executive Orders 12866, 13563 and
13771
Executive Orders (E.O.s) 12866 and
13563 direct agencies to assess all costs
and benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). E.O. 13563 emphasizes the
importance of quantifying both costs
and benefits of reducing costs, of
harmonizing rules, and of promoting
flexibility. E.O. 12866, Regulatory
Planning and Review, defines
‘‘significant regulatory action’’ to mean
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.’’
VA has examined the economic,
interagency, budgetary, legal, and policy
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implications of this regulatory action,
and it has been determined not to be a
significant regulatory action under E.O.
12866. This proposed rule is not
expected to be an E.O. 13771 regulatory
action because this proposed rule is not
significant under E.O. 12866.
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
64.008—Veterans Domiciliary Care;
64.011—Veterans Dental Care; 64.012—
Veterans Prescription Service; 64.013—
Veterans Prosthetic Appliances;
64.014—Veterans State Domiciliary
Care; 64.015—Veterans State Nursing
Home Care; 64.024—VA Homeless
Providers Grant and Per Diem Program;
64.026—Veterans State Adult Day
Health Care; 64.029—Purchase Care
Program; 64.033—VA Supportive
Services for Veteran Families Program;
64.039—CHAMPVA; 64.040—VHA
Inpatient Medicine; 64.041—VHA
Outpatient Specialty Care; 64.042—
VHA Inpatient Surgery; 64.043—VHA
Mental Health Residential; 64.044—
VHA Home Care; 64.045—VHA
Outpatient Ancillary Services; 64.046—
VHA Inpatient Psychiatry; 64.047—
VHA Primary Care; 64.048—VHA
Mental Health clinics; 64.049—VHA
Community Living Center; 64.050—
VHA Diagnostic Care; 64.054—Research
and Development.
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 December 8,
2017, for publication.
List of Subjects in 38 CFR Part 1
Administrative practice and
procedure, Archives and records,
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Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Proposed Rules
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: January 12, 2018.
Janet 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
1. The authority citation for part 1
continues to read as follows:
■
Authority: 38 U.S.C. 501, and as noted in
specific sections.
2. Amend § 1.460 by adding, in
alphabetical order, definitions for
‘‘health information exchange’’ and
‘‘health information exchange
community partner.’’
■
§ 1.460
Definitions.
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*
*
*
*
*
Health information exchange. The
term ‘‘health information exchange’’
means the electronic transfer of health
information among health care
professionals, health plans,
governmental agencies providing
benefits, and other persons and entities
according to nationally recognized
standards that allow the participants to
appropriately access and securely share
patients’ vital medical information to
improve the quality, safety, and
efficiency of health care delivery.
Health information exchange
community partner. The term ‘‘health
information exchange community
partner’’ means a health care provider,
health plan, governmental agency
providing benefits, or other person or
entity with whom VA shares patients’
vital medical information according to
nationally recognized standards.
*
*
*
*
*
■ 3. Amend § 1.475 by redesignating
paragraph (d) as paragraph (e), adding a
new paragraph (d) and revising newly
redesignated paragraph (e) to read as
follows:
§ 1.475
Form of written consent.
*
*
*
*
*
(d) Establishing written consent. A
written consent authorizing the
disclosure may be demonstrated by:
(1) A written consent meeting the
criteria set forth in paragraph (a) of this
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section that is presented to VA in
physical form; or
(2) A written attestation by a health
information exchange community
partner that the patient submitted
legally sufficient consent meeting the
criteria set forth in paragraph (a),
provided that:
(i) Within 10 business days of the
health information exchange
community partner’s attestation, the
partner either makes the written consent
form available for electronic retrieval by
VA or produces the written consent
form to VA; or
(ii) The health information exchange
community partner complies with a
memorandum of understanding signed
by the partner and VA that outlines:
(A) How the written consent will be
retained in accordance with VHA
Records Control Schedule (RCS) 10–1;
(B) How VA can request the consent
form from the partner; and
(C) How the partner can send the
consent form to VA.
(e) Required Form. It is not necessary
to use any particular form to establish
a consent referred to in paragraph (a) of
this section, however, VA Form 10–
5345, titled Request for and
Authorization to Release Medical
Records or Health Information, complies
with all applicable legal requirements
and may be used for such purpose.
[FR Doc. 2018–00758 Filed 1–18–18; 8:45 am]
BILLING CODE 8320–01–P
DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety
Administration
49 CFR Part 395
[Docket No. FMCSA–2017–0360]
Hours of Service of Drivers of
Commercial Motor Vehicles; Proposed
Regulatory Guidance Concerning the
Transportation of Agricultural
Commodities; Extension of Comment
Period
Federal Motor Carrier Safety
Administration (FMCSA), DOT
ACTION: Proposed regulatory guidance;
extension of comment period.
AGENCY:
FMCSA extends the public
comment period for the Agency’s
December 20, 2017, notice announcing
the proposed regulatory guidance
concerning the transportation of
agricultural commodities. On December
22, 2017, the American Trucking
Associations, Inc. (ATA) requested a 30day extension of the comment period.
SUMMARY:
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2765
Additional requests for extension of the
comment period have been received.
The Agency extends the January 19,
2018, deadline for the submission of
public comments to February 20, 2018.
DATES: FMCSA extends the comment
period for the notice of proposed
regulatory guidance published on
December 20, 2017 at 82 FR 60360. You
must submit comments on or before
February 20, 2018.
ADDRESSES: You may insert comments
identified by Federal Docket
Management System Number FMCSA–
2017–0360 by any of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
• Mail: Docket Management Facility,
U.S. Department of Transportation, 1200
New Jersey Avenue SE, West Building,
Ground Floor, Room W12–140,
Washington, DC 20590–0001.
• Hand Delivery or Courier: West
Building, Ground Floor, Room W12–
140, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays.
• Fax: (202) 493–2251.
To avoid duplication, please use only
one of these four methods. See the
‘‘Public Participation and Request for
Comments’’ portion of the
SUPPLEMENTARY INFORMATION section for
instructions on submitting comments.
FOR FURTHER INFORMATION CONTACT: Mr.
Thomas Yager, Chief, Driver and Carrier
Operations Division, Federal Motor
Carrier Safety Administration, U.S.
Department of Transportation, 1200
New Jersey Avenue SE, Washington, DC
20590, phone (614) 942–6477, email
MCPSD@dot.gov.
SUPPLEMENTARY INFORMATION:
I. Public Participation and Request for
Comments
A. Submitting Comments
If you submit a comment, please
include the docket number listed above,
indicate the specific section of this
document to which your comment
applies, and provide a reason for each
suggestion or recommendation. You
may submit your comments and
material online or by fax, mail, or hand
delivery. FMCSA recommends that you
include your name and a mailing
address, an email address, or a phone
number in the body of your document
so that FMCSA can contact you if there
are questions regarding your
submission.
To submit your comment online, go to
https://www.regulations.gov, put the
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]]>Agencies
[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Proposed Rules]
[Pages 2762-2765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00758]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 1
RIN 2900-AP90
Consent for Release of VA Medical Records
AGENCY: Department of Veterans Affairs.
ACTION: Proposed rule.
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SUMMARY: The Department of Veterans Affairs (VA) proposes to amend its
regulations to clarify that a valid consent authorizing the Department
to release the patient's confidential VA medical records to a health
information exchange (HIE) community partner may be established not
only by VA's physical possession of the written consent form, but also
by the HIE community partner's written (electronic) attestation that
the patient has, in fact, provided such consent. This proposed rule
would be a reinterpretation of an existing, long-standing regulation
and is necessary to facilitate modern requirements for the sharing of
patient records with community health care providers, health plans,
governmental agencies, and other entities participating in electronic
HIEs. This revision would ensure that more community health care
providers and other HIE community partners can deliver informed medical
care to patients by having access to the patient's VA medical records
at the point of care.
DATES: Comment Date: Comments must be received on or before March 20,
2018.
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 1063B, Washington, DC 20420; or by fax to (202)
273-9026. Comments should indicate that they are submitted in response
to ``RIN 2900-AP90 Consent for Release of VA Medical Records.'' Copies
of comments received will be available for public inspection in the
Office of Regulation Policy and Management, Room 1063B, between the
hours of 8:00 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
(FDMS) at www.Regulations.gov.
FOR FURTHER INFORMATION CONTACT: Stephania Griffin, Director, Veterans
Health Administration Information Access and Privacy Office, Department
of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420;
[email protected], (704) 245-2492 (This is not a toll-free
number.)
SUPPLEMENTARY INFORMATION: Under 38 U.S.C. 7332, VA must keep
confidential all records of identity, diagnosis, prognosis, or
treatment of a patient in connection with any program or activity
carried out by VA related to drug abuse, alcoholism or alcohol abuse,
infection with human immunodeficiency virus, or sickle cell anemia, and
must obtain patients' written consent before VA may disclose the
protected information unless authorized by the statute. This
requirement applies to communications between VA and community health
care providers for the purposes of treatment, except in certain
situations, for instance in medical emergencies and when the records
are sent to a non-Department entity that provides hospital care to
patients as authorized by the Secretary. 38 U.S.C. 7332(b)(2)(A) and
(H); Public Law 115-26 (April 19, 2017). Although section 7332 does not
explicitly require that the written consent physically be in VA's
possession at the time of the disclosure, VA had interpreted the
statute to require such possession, and therefore applied 38 CFR 1.475
consistent with that interpretation. VA has reexamined that statutory
interpretation in light of contemporary
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healthcare industry standards and proposes to revise Sec. 1.475 to
reflect this updated reading of section 7332. This proposed rule would
revise 38 CFR 1.475 to permit VA to release section 7332-protected
medical records to eligible community partners, even if VA does not
physically have the patient's written consent, provided that specified
criteria are met.
The ability to quickly release section 7332-protected information
has become increasingly important as VA strives to support veterans'
choice to seek care in the community and create innovative ways to
provide effective and timely care to veterans. In this regard, VA has
entered into an agreement to participate in an HIE to help facilitate
the transfer of information between different organizations. An HIE is
the electronic transfer of health information among organizations
according to nationally recognized standards. The organizations that
participate (HIE community partners) range from community health care
providers and health plans to governmental agencies providing benefits,
such as the Social Security Administration (SSA).
The interpretation that valid consent may be established only by
VA's physical possession of the written consent has left many HIE
community partners unable to access veterans' VA medical records at the
point of care. While an estimated three out of four veterans enrolled
in VA's health care system also seek medical care in the community, HIE
community partners' requests for their VA health records must
frequently be denied because VA does not have a consent on file, and
many HIE community partners therefore either must delay care to
veterans or provide treatment to veterans without having the benefit of
reviewing the veteran's full medical history.
The reason for the low rate of consent is not because veterans
object to providing consent; veteran participation is almost always
favorable when asked to provide consent. The primary obstacle is that
veterans will often seek care in the community prior to having the
opportunity to provide the consent form to VA and are then left without
any means of getting the consent into VA's physical possession promptly
once they are at the community health care facility.
By allowing HIE community partners to attest that they have, in
fact, obtained a valid consent, VA would be able to collect consent in
a broader array of circumstances. Most importantly, this would allow VA
to release a veteran's medical records to an HIE community partner,
such as a community health care provider or SSA, once the partner
attests that they have collected valid consent, without VA having to
wait for the document to be furnished. This would allow for HIE
community partners to provide veterans with the most informed care,
would allow VA to more expediently provide veterans' records for the
adjudication of their SSA disability claims, and would also allow for
VA to continue innovating and creating new ways for veterans to receive
timely and high quality health care.
VA believes that this new interpretation of section 7332--to permit
disclosure to an HIE community partner pursuant to the partner's
attestation regarding written consent, would uphold veterans' right to
privacy. As explained in greater detail below, such disclosure would
still require a legally sufficient written consent. We clarify that the
only change would be that a valid consent authorizing disclosure may be
established not only by VA's physical possession of the written consent
form but also by the HIE community partner's attestation that the
veteran has submitted legally sufficient consent. Moreover, in the
private sector under the Health Insurance Portability and
Accountability Act (HIPAA) Privacy Rule, health care providers are able
to release a patient's confidential medical records to another one of
the patient's treating providers without written consent. Therefore,
VA's privacy protections would remain more robust than those of the
private sector generally and greater than those required by the HIPAA
Privacy Rule.
This proposed rule would revise 38 CFR 1.460 to include definitions
for ``health information exchange'' and ``health information exchange
community partner'' as described above. Further, the rule would revise
1.475 as follows. Current paragraph (d) would be redesignated as
paragraph (e) and would be revised as explained below. New paragraph
(d) would provide the criteria to establish written consent that would
authorize the disclosure of confidential VA medical records.
Specifically, it would establish that, in addition to physical
possession of a patient's written consent, VA may release the patient's
protected medical information to an HIE community partner pursuant to
that partner's attestation that valid consent has been obtained. To
clarify, this paragraph would not require VA to provide the records to
HIE community partners just because the partner submitted an
attestation; instead, VA would have the discretion to send the records.
Proposed paragraph (d)(1) states that written consent may be
established by VA's physical possession of the patient's written
consent that meets the criteria in paragraph (a) of this section. This
is how VA traditionally collected consent forms.
Paragraph (d)(2) would provide an alternative for disclosure of
section 7332-protected information. VA would also be able to disclose
the protected information to an HIE community partner as long as two
criteria are met. Initially, we note that this alternative for
disclosure would be limited to VA's partners in the HIE because the
partners have all signed an agreement to comply with certain standards
of practice. Additionally, all partners would be required to have the
technological capabilities to provide the requisite attestation.
The first proposed criterion is that the HIE community partner must
provide written attestation that the patient has submitted legally
sufficient consent to them. This requirement is necessary because 38
U.S.C. 7332 and 38 CFR 1.475 still require the veteran provide legally
sufficient written consent to release section 7332-protected
information. Therefore, in order for VA to release the records to the
HIE community partner, VA must have an attestation or some
documentation that the patient provided legally sufficient written
consent.
To clarify, ``written attestation'' would not require a physical
document and a wet signature; electronic attestations satisfy this
requirement and are the expected form of attestation from the HIE
community partner. VA would not specifically require the attestation to
be electronic in order to provide for flexibility if there are changes
in technology and best practices. However, VA envisions the vast
majority, if not all, of the attestations would be electronic through
approved messaging with the HIE community partners. This proposed rule
would allow for VA's community partners to electronically attest,
through the computer software, that the veteran submitted legally
sufficient written consent. At that time, VA would be able to release
the veteran's medical records electronically to the HIE community
partner.
In addition to the written attestation, paragraph (d)(2) would
require that VA have the ability to retrieve or obtain the written
consent. There are two ways in which VA can obtain the records. First,
proposed paragraph (d)(2)(i) provides that a .HIE community partner can
make the consent form available to VA within 10 business days of its
attestation. This can be accomplished either by storing
[[Page 2764]]
the written consent form electronically for access by VA or by sending
the written consent form to VA.
Second, paragraph (d)(2)(ii) would provide that the HIE community
partner can maintain the patient's written consent form in accordance
with a memorandum of understanding (MOU) that is drafted and signed by
VA and the HIE community partner. The MOU would ensure that the
patient's records are retained in accordance with VA record retention
requirements set forth in VHA Records Control Schedule (RCS) 10-1. Even
though VA would not require the written consent to be physically in
VA's possession since it is a VA record, the HIE would have to retain
the consent form according to VA's record retention requirements.
Paragraph (d)(2)(ii) would also require that the MOU outline how VA can
request the consent form from the HIE community partner and how the HIE
community partner can make the consent form available to VA. In this
regard, VA and the partner would determine a mutually agreeable
timeframe to comply with a request by VA for a copy of the consent
form.
As explained above current paragraph (d) would be redesignated as
new paragraph (e). This paragraph would be revised to update the name
of VA Form 10-5345. Specifically, current paragraph (d) provides that
it was not necessary to use any particular form to establish a consent
referred to in paragraph (a) of this section, however, VA Form 10-5345,
titled Request for and Consent to Release of Medical Records Protected
by 38 U.S.C. 7332, may be used for such purpose. VA Form 10-5345 has
been updated and renamed Request for and Authorization to Release
Medical Records or Health Information. Accordingly, VA would revise the
paragraph to reflect the new name of VA Form 10-5345.
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). The overall impact of the proposed rule on small
entities would be minimal as the proposed rule would only require that
entities attest that they received the veteran's consent and make the
written consent available to VA. These administrative burdens are
similar to current burdens related to medical privacy and will not have
a significant economic impact on these entities. On this basis, the
Secretary certifies that the adoption of 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. Therefore, under 5 U.S.C. 605(b), this rulemaking is
exempt from the initial and final regulatory flexibility analysis
requirements of sections 603 and 604.
Executive Orders 12866, 13563 and 13771
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess
all costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). E.O.
13563 emphasizes the importance of quantifying both costs and benefits
of reducing costs, of harmonizing rules, and of promoting flexibility.
E.O. 12866, Regulatory Planning and Review, defines ``significant
regulatory action'' to mean 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.''
VA has examined the economic, interagency, budgetary, legal, and
policy implications of this regulatory action, and it has been
determined not to be a significant regulatory action under E.O. 12866.
This proposed rule is not expected to be an E.O. 13771 regulatory
action because this proposed rule is not significant under E.O. 12866.
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 64.008--Veterans Domiciliary
Care; 64.011--Veterans Dental Care; 64.012--Veterans Prescription
Service; 64.013--Veterans Prosthetic Appliances; 64.014--Veterans State
Domiciliary Care; 64.015--Veterans State Nursing Home Care; 64.024--VA
Homeless Providers Grant and Per Diem Program; 64.026--Veterans State
Adult Day Health Care; 64.029--Purchase Care Program; 64.033--VA
Supportive Services for Veteran Families Program; 64.039--CHAMPVA;
64.040--VHA Inpatient Medicine; 64.041--VHA Outpatient Specialty Care;
64.042--VHA Inpatient Surgery; 64.043--VHA Mental Health Residential;
64.044--VHA Home Care; 64.045--VHA Outpatient Ancillary Services;
64.046--VHA Inpatient Psychiatry; 64.047--VHA Primary Care; 64.048--VHA
Mental Health clinics; 64.049--VHA Community Living Center; 64.050--VHA
Diagnostic Care; 64.054--Research and Development.
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 December 8, 2017, for publication.
List of Subjects in 38 CFR Part 1
Administrative practice and procedure, Archives and records,
[[Page 2765]]
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: January 12, 2018.
Janet 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, and as noted in specific sections.
0
2. Amend Sec. 1.460 by adding, in alphabetical order, definitions for
``health information exchange'' and ``health information exchange
community partner.''
Sec. 1.460 Definitions.
* * * * *
Health information exchange. The term ``health information
exchange'' means the electronic transfer of health information among
health care professionals, health plans, governmental agencies
providing benefits, and other persons and entities according to
nationally recognized standards that allow the participants to
appropriately access and securely share patients' vital medical
information to improve the quality, safety, and efficiency of health
care delivery.
Health information exchange community partner. The term ``health
information exchange community partner'' means a health care provider,
health plan, governmental agency providing benefits, or other person or
entity with whom VA shares patients' vital medical information
according to nationally recognized standards.
* * * * *
0
3. Amend Sec. 1.475 by redesignating paragraph (d) as paragraph (e),
adding a new paragraph (d) and revising newly redesignated paragraph
(e) to read as follows:
Sec. 1.475 Form of written consent.
* * * * *
(d) Establishing written consent. A written consent authorizing the
disclosure may be demonstrated by:
(1) A written consent meeting the criteria set forth in paragraph
(a) of this section that is presented to VA in physical form; or
(2) A written attestation by a health information exchange
community partner that the patient submitted legally sufficient consent
meeting the criteria set forth in paragraph (a), provided that:
(i) Within 10 business days of the health information exchange
community partner's attestation, the partner either makes the written
consent form available for electronic retrieval by VA or produces the
written consent form to VA; or
(ii) The health information exchange community partner complies
with a memorandum of understanding signed by the partner and VA that
outlines:
(A) How the written consent will be retained in accordance with VHA
Records Control Schedule (RCS) 10-1;
(B) How VA can request the consent form from the partner; and
(C) How the partner can send the consent form to VA.
(e) Required Form. It is not necessary to use any particular form
to establish a consent referred to in paragraph (a) of this section,
however, VA Form 10-5345, titled Request for and Authorization to
Release Medical Records or Health Information, complies with all
applicable legal requirements and may be used for such purpose.
[FR Doc. 2018-00758 Filed 1-18-18; 8:45 am]
BILLING CODE 8320-01-P
