Disclosure of Information to Organ Procurement Organizations, 48239-48242 [E7-16648]

Agencies

• DEPARTMENT OF VETERANS AFFAIRS

[Federal Register Volume 72, Number 163 (Thursday, August 23, 2007)]
[Rules and Regulations]
[Pages 48239-48242]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16648]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 1

RIN 2900-AM65


Disclosure of Information to Organ Procurement Organizations

AGENCY: Department of Veterans Affairs.

ACTION: Interim final rule.

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SUMMARY: This document amends the Department of Veterans Affairs (VA) 
regulations to implement section 204 of the Veterans Benefits, Health 
Care, and Information Technology Act of 2006. This regulatory change 
will provide authority for VA to provide individually-identifiable VA 
medical records of veterans or dependents of veterans who are deceased 
or whose death is imminent to representatives of organ procurement 
organizations (OPOs) as defined in section 371(b) of the Public Health 
Service Act (PHS Act), eye banks, and tissue banks to determine whether 
the patients are suitable potential donors.

DATES: Effective Date: This interim final rule is effective August 23, 
2007. Comments must be received by VA on or before October 22, 2007.

ADDRESSES: Written comments may be submitted through https://
www.Regulations.gov; by mail or hand-delivery to the Director, 
Regulations Management (00REG), Department of Veterans Affairs, 810 
Vermont Ave., 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-AM65--``Disclosure of Information to Organ Procurement 
Organizations.'' 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 a.m. and 4:30 p.m., Monday through 
Friday (except holidays). Please call (202) 273-9515 for an 
appointment. In addition, during the comment period, comments may be 
viewed online through the Federal Docket Management System (FDMS) at 
https://www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Stephania Putt, Veterans Health 
Administration Privacy Officer, Office of Information (19F2), Veterans 
Health Administration, Department of Veterans Affairs, 810 Vermont 
Ave., NW., Washington DC 20420, (727) 320-1839.

SUPPLEMENTARY INFORMATION: Organ procurement organizations, eye banks, 
and tissue banks in the United States operate under specific statutory 
and regulatory authority. The statutory authority is contained in 
specific provisions of the Social Security Act (Act) and the PHS Act.
    As noted in the preface to the 1988 edition of the United States 
Code, because title 42, United States Code (USC), has not been enacted 
into positive law, the provisions in title 42, U.S.C., are prima facie 
evidence of the laws rather than legal evidence of the laws. 
Consequently, the Secretary of Health and Human Services (HHS) 
generally uses and refers to the provisions of the Act and the PHS Act 
rather than the provisions as codified in title 42, U.S.C., when 
implementing the provisions of those laws in regulations. e.g., 21 CFR 
1271.1, 1271.10. Congress enacted title 38, U.S.C., into positive law, 
(Pub. L. 85-857 (1958) and reorganized and renumbered in Pub. L. 102-40 
and 102-83 (1991)); as a result, the provisions of title 38 as 
published are legal evidence of the laws contained therein. People who 
deal with the VA are accustomed to using the section numbering in title 
38, U.S.C., as published.
    Because VA cites the code sections contained in title 38 and HHS 
cites the sections of the public laws underlying title 42, the VA will 
use the HHS citation form for laws under its responsibility, and title 
38 section numbers in the regulations. However, for the convenience of 
the persons who will interact with the VA in the course of the VA's 
implementation of these regulations, the VA includes the title 42, 
U.S.C., cross-reference for the provisions of the Act and PHS Act when 
first cited in the preamble and the rule.
    Section 1138(a) of the Act (42 U.S.C. 1320b-8(a)), requires all 
hospitals or critical access hospitals to establish written protocols 
for the identification of potential organ donors, and for referrals of 
potential donors to qualified OPOs that meet the criteria of section 
1138(b)(1)(A) of the Act. Section 1138(b) provides that a qualified 
OPO: (1) Is described in section 371(b) of the PHS Act (42 U.S.C. 
273(b)) that is operating under a grant made under section 371(a) of 
the PHS Act, or (2) has been certified or recertified by the Secretary 
of Health and Human Services (HHS Secretary) within the previous two 
years, or four years if the Secretary determines that the 
organization's past practices merits such treatment as meeting the HHS 
Secretary's standards to be a qualified OPO. The HHS Secretary shall 
designate only one OPO for each service area as provided in section 
371(b)(1)(E) of the PHS Act. The implementing regulations are at 42 CFR 
486.301-.348.
    Ocular tissue and other tissues are regulated by HHS under section 
361 of the PHS Act (42 U.S.C. 264). The implementing regulations are in 
21 CFR part 1271. These regulations establish the requirements for eye 
banks and tissue banks.
    Under these respective sets of regulations, OPOs on the one hand 
and eye banks and tissue banks on the other hand are provided access by 
medical facilities to the protected health information of patients who 
are deceased or whose death is imminent without the prior written 
authorization of the patients so that representatives of the OPOs and 
eye banks and tissue banks may determine whether the patients may be 
suitable potential donors.
    The rule promulgated by HHS under section 264 of the administrative 
simplification provisions of the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) (Pub. L. 104-191, 110 Stat. 1936, 
2033-34 (1996)) (commonly referred to as the HIPAA Privacy Rule) 
provides express authority at 45 CFR 164.512(h) for disclosures of 
protected health information by covered health care providers to 
``OPOs, or other entities engaged in the procurement, banking or 
transplantation of organs, eyes, or tissue for the purpose of 
facilitating organ, eye or tissue donation and transplantation'' 
conducted under the provisions of the PHS Act and its implementing 
regulations. Disclosures to eye banks and tissue banks are authorized 
under this language.
    The Veterans Health Administration (VHA) is a covered entity under 
the HIPAA Privacy Rule for purposes of

[[Page 48240]]

care provided under chapter 17 of title 38, U.S.C. However, VHA 
protected health information covered by the HIPAA Privacy Rule is also 
covered by sections 5701 and 7332 of title 38, U.S.C. Prior to 
enactment of section 204 of Public Law 109-461, section 5701(a) limited 
VA's authority to release the names and home addresses of veterans and 
their dependents, and section 7332 precluded VHA from releasing 
protected health information concerning treatment for sickle cell 
anemia, drug abuse and alcoholism and alcohol abuse, and testing and 
treatment for the human immunodeficiency virus infection for all but a 
very limited number of purposes. Neither section provided statutory 
authority for VHA to provide protected health information on deceased 
patients or patients whose death was imminent to OPOs, eye banks, and 
tissue banks for consideration as non-living donors in the national 
donation programs.
    Although not subject to the mandatory provisions of section 1138 of 
the Act and section 361 of the PHS Act, VHA tried to collaborate with 
OPOs, eye banks, and tissue banks in accordance with the statutes and 
regulations governing these entities to the extent possible within the 
restrictions on disclosure of individually-identified patient medical 
information imposed by sections 5701 and 7332. However, VHA discovered 
that the limitations of these statutes rendered VHA collaboration with 
these entities ineffective. Consequently, VA requested legislation to 
amend sections 5701 and 7332 to provide specific statutory authority 
for VHA to disclose protected health information covered by these 
statutes to OPOs, eye banks, and tissue banks without the prior written 
authorization of deceased patients or patients whose death is imminent 
for evaluation whether the patients may be suitable potential donors.
    Congress responded by enacting section 204 of Public Law 109-461, 
which amended sections 5701 and 7332 of title 38, U.S.C., to authorize 
VHA to release information about deceased or near-death veterans or 
their dependants to donor organizations, so that they may determine 
whether these individuals are, or after death, will be suitable organ, 
tissue or eye donors. The legislation directs the Secretary of Veterans 
Affairs to prescribe regulations implementing VA's new disclosure 
authority by June 20, 2007.
    New section 5701(k)(2) of title 38, U.S.C., specifically states 
that an OPO for purposes of disclosure authority under section 5701 
(and under section 7332 as that statute was amended) has the meaning 
given the term ``qualified organ procurement organization'' in section 
371(b) of the PHS Act. Section 5701(k)(1)(B)(i) provides that OPOs 
include eye and tissue banks. However, section 5701, as amended, does 
not define eye and tissue banks, and the definition of OPOs in section 
371(b) of the PHS Act does not include eye and tissue banks. In fact, 
OPOs are not tissue banks or eye banks, although some OPOs have eye 
banks or tissue banks that are administratively separate from the OPOs.
    The amendment to section 5701 also provides that OPOs include 
entities that the Secretary of Veterans Affairs has determined are 
``(I) substantially similar in function, professionalism, and 
reliability to an organ procurement organization [as defined in section 
371(b) of the PHS Act]; and (II) should be treated for purposes of this 
subsection in the same manner as an organ procurement organization.'' 
38 U.S.C. 5701(k)(1)(B)(ii). The VA construes this language to provide 
authority for VA to promulgate regulations to authorize disclosure of 
protected health information to eye and tissue banks regulated by HHS 
under the authority of section 361 of the PHS Act, and the implementing 
regulations in 21 CFR part 1271.
    As discussed above, there are long-established, dynamic, national 
organ, eye and tissue donation programs in the United States involving 
non-VHA medical facilities. HHS periodically certifies and recertifies 
OPOs and requires eye banks and tissue banks to register with the Food 
and Drug Administration in order to participate in these programs.
    VHA medical facilities also perform organ, eye and tissue 
transplants with organs, eyes and tissues received from hospitals 
subject to section 1138(a) of the Act and the regulation at 42 CFR 
482.45. The regulation requires every Medicare and Medicaid hospital to 
perform the following concerning organ, eye, and tissue procurement 
activities: Have an agreement with its designated OPO to report all 
deaths and imminent deaths to the OPO in a timely manner, collaborate 
with the OPO to inform families of potential donors of their donation 
options, and cooperate with the OPO to maintain potential donors while 
testing takes place. The regulation also requires hospitals to 
cooperate with tissue banks and eye banks to ensure that all usable 
tissues and eyes are obtained.
    The Secretary of Veterans Affairs, in the exercise of the 
Secretary's discretion in administering title 38, U.S.C., has 
determined that in light of all factors, it is unnecessary, 
counterproductive and confusing to the general public for VHA to 
establish a separate approval process for OPOs, eye banks, and tissue 
banks so that VHA's medical facilities can provide information about 
potential donors to these entities. Consequently, VHA will disclose 
protected health information to certified OPOs, and to eye banks and 
tissue banks that have registered with the FDA, and are procuring 
organs, corneas, and tissues from deceased donors for the purpose of 
transplantation in compliance with the applicable HHS regulations. VHA 
will not require these organizations to submit any information or meet 
any requirements beyond those required by HHS. These regulations 
provide that VHA medical facilities are to periodically confirm with 
HHS its approval or certification of each OPO, eye bank or tissue bank 
that seeks to obtain access to VHA protected health information in 
order to perform its duties under HHS statutes and regulations.
    Sections 5701 and 7332, as amended by section 204 of Public Law 
109-461, and as implemented by these regulations, are limited to 
disclosure of information about veterans and their dependents. 
Consequently, the regulations do not address disclosure of protected 
health information about other individuals who may be treated in VHA 
medical facilities to OPOs, eye banks, or tissue banks. For example, 
these regulations do not apply to disclosure of protected health 
information about members of the armed forces because disclosure of 
their protected health information for donation purposes is governed by 
10 U.S.C. 1109 and the implementing Department of Defense regulations.
    The regulations implementing the amendments to 38 U.S.C. 5701 and 
7332 are inserted in the VA regulations implementing those provisions. 
The regulations addressing section 7332 are at 38 CFR 1.460-.499, and 
the regulations concerning section 5701 are at 38 CFR 1.500-.527. As 
part of the interim final rule, VA is amending the definitions 
contained in 38 CFR 1.460 to include definitions for terms used in the 
new 1.485a implementing the organ donation amendments to section 7332.
    The amendments to sections 5701 and 7332 concerning living patients 
are intended to be limited to disclosures of information about 
individual patients whose death is imminent. VA has provided a 
definition of what the term ``near death'' means for donation purposes. 
This definition was drafted by the VA National Transplant Program in 
association with the Veterans Health Administration (VHA) National 
Center

[[Page 48241]]

for Ethics, which provides guidance to VHA health care practitioners on 
medical ethics issues in VHA. VHA understands the proposed definition 
of ``near death'' to be consistent with the standard historically 
applied in non-VHA health care facilities when determining whether to 
make a living patient's medical records available for representatives 
of OPOs, eye banks and tissue banks, specifically under 42 CFR 
482.45(a) Medicare and Medicaid hospitals will make available records 
on ``an individual whose death is imminent.'' However, VHA recognizes 
that this issue may be a sensitive subject. VA therefore specifically 
solicits comments on the definition of ``near death'' used in the 
regulations.

Administrative Procedure Act

    Pursuant to 5 U.S.C. 553(b)(3)(B), we find that there is good cause 
to dispense with advance public notice and opportunity to comment on 
this rule because any delay in promulgating the rule would be contrary 
to the public interest. In enacting section 204 of Public Law 109-461, 
Congress recognized the public's immediate need for VA's disclosure of 
organ donor information and specified that VA shall prescribe rules 
implementing the new law within 180 days. Also, as documented by 
information and data on www.organdonor.gov, the number of patients 
awaiting organ transplants far exceeds the number of available organs. 
Every day, 17 patients die waiting for an organ. VA's immediate 
collaboration with OPOs, eye banks, and tissue banks to facilitate 
organ, eye and tissue donation will result in individuals receiving 
life-saving or life-enhancing transplants that otherwise would be 
unavailable. Accordingly, it would be contrary to the intent of 
Congress to delay an initiative that seeks to address a compelling 
public need, while VA engages in advance notice and opportunity to 
comment. Pursuant to 5 U.S.C. 553(d), and for the reasons stated above, 
we also find that there is good cause to dispense with the requirement 
that a substantive rule be published no less than 30 days before its 
effective date.

Paperwork Reduction Act of 1995

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

Regulatory Flexibility Act

    The Secretary hereby certifies that this interim final rule will 
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 rule governs VA's disclosure of individuals' 
medical records to certain Organ Procurement Organizations, eye banks, 
and tissue banks, some of which may be small entities. However, it will 
not affect a substantial number of small entities and will not have a 
significant economic impact on any such entity. Therefore, under 5 
U.S.C. 605(b), this interim final rule is exempt from the initial and 
final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 
604.

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 ``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 the Executive 
Order.
    The economic, interagency, budgetary, legal, and policy 
implications of this interim final rule have been examined and it has 
been determined to be a significant regulatory action under Executive 
Order 12866 because it is likely to result in a rule that may raise 
novel legal or policy issues arising out of legal mandates, the 
President's priorities, or principles set forth in the Executive Order.

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 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 1 year. This rule will have no such effect on State, 
local, and tribal governments, or on the private sector.

Catalog of Federal Domestic Assistance Numbers and Titles

    The Catalog of Federal Domestic Assistance numbers and titles for 
the programs affected by this document are 64.009, Veterans Medical 
Care Benefits; 64.010, Veterans Nursing Home Care; and 64.011, Veterans 
Dental Care.

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.

    Approved: June 18, 2007.
Gordon H. Mansfield,
Deputy Secretary of Veterans Affairs.

0
For the reasons set out in the preamble, the Department of Veterans 
Affairs amends 38 CFR part 1 to read 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. In Sec.  1.460, add definitions for ``Agreement'', ``Deceased'', 
``Eye bank and tissue bank'', ``Individual'', ``Near death'', ``Organ 
Procurement Organization'', ``Procurement organization'', and ``VHA 
health care facility'' in alphabetical order to read as follows:


Sec.  1.460  Definitions.

* * * * *
    Agreement. The term ``agreement'' means a document that a VA health 
care facility develops in collaboration with an Organ Procurement 
Organization, eye bank or tissue bank with written, detailed 
responsibilities and obligations of the parties with regard to 
identifying potential donors and facilitating the donation process.
* * * * *
    Deceased. The term ``deceased'' means death established by either 
neurological criteria (brain death) or cardiopulmonary criteria 
(cardiac death). Brain death is the irreversible

[[Page 48242]]

cessation of all brain function. Cardiac death is the irreversible 
cessation of circulatory and respiratory function. In both cases, 
``irreversible'' means that function will not resume spontaneously and 
will not be restarted artificially.
* * * * *
    Eye bank and tissue bank. The term ``eye bank and tissue bank'' 
means an ``establishment'' as defined in 21 CFR 1271.3, pursuant to 
section 361 of the Public Health Service Act (42 U.S.C. 264) that has a 
valid, current registration with the Federal Food and Drug 
Administration (FDA) as required under 21 CFR part 1271.
    Individual. The term ``individual'' means a veteran, as defined in 
38 U.S.C. 101(2), or a dependent of a veteran, as defined in 38 U.S.C. 
101(3) and (4)(A).
* * * * *
    Near death. The term ``near death'' means that in the clinical 
judgment of the patient's health care provider, the patient's death is 
imminent.
    Organ Procurement Organization. The term ``Organ Procurement 
Organization'' (OPO) means an organization that performs or coordinates 
the procurement, preservation, and transportation of organs and 
maintains a system of locating prospective recipients for available 
organs.
    Procurement organization. The term ``procurement organization'' 
means an organ procurement organization, eye bank, and/or tissue banks 
as defined in this section.
* * * * *
    VHA health care facilty. The term ``VHA health care facility'' 
means a VA medical center, VA emergency room, VA nursing home or other 
facility as defined in 38 U.S.C. 1701(3).
* * * * *

0
3. Add new Sec.  1.485a, to read as follows:


Sec.  1.485a  Eye, organ and tissue donation.

    A VHA health care facility may disclose the individually-identified 
medical record information of an individual covered by Sec. Sec.  1.460 
through 1.499 of this part to an authorized representative of a 
procurement organization for the purpose of facilitating determination 
of whether the individual is a suitable potential organ, eye, or tissue 
donor if:
    (a) The individual is currently an inpatient in a VHA health care 
facility;
    (b) The individual is, in the clinical judgment of the individual's 
primary health care provider, near death or deceased;
    (c) The VHA health care facility has a signed agreement with the 
procurement organization in accordance with the applicable requirements 
of the United States Department of Health and Human Services (HHS); and
    (d) The VHA health care facility has confirmed with HHS that it has 
certified or recertified the organ procurement organization as provided 
in the applicable HHS regulations. VA medical centers must verify 
annually in January of each calendar year with the Food and Drug 
Administration (FDA) that an eye bank and tissue bank has complied with 
the FDA registration requirements of 21 CFR part 1271 before permitting 
an eye bank or tissue bank to receive protected health information.

(Authority: 38 U.S.C. 5701(k), 7332(b)(2)(E))


0
4. Add new Sec.  1.514b, to read as follows:


Sec.  1.514b  Disclosures to procurement organizations.

    A VHA health care facility may disclose the name and home address 
of an ``individual'' as defined in Sec.  1.460 to an authorized 
representative of a ``procurement organization'' as also defined in 
Sec.  1.460 for the purpose of facilitating a determination by the 
procurement organization of whether the individual is a suitable 
potential organ, eye, or tissue donor if:
    (a) The individual is currently an inpatient in a VHA health care 
facility;
    (b) The individual is, in the clinical judgment of the individual's 
primary health care provider, near death or is deceased as defined in 
Sec.  1.460;
    (c) The VHA health care facility has a signed agreement with the 
procurement organization in accordance with the applicable requirements 
of the United States Department of Health and Human Services (HHS); and
    (d) The VHA health care facility has confirmed with HHS that it has 
certified or recertified the organ procurement organization as provided 
in the applicable HHS regulations. VA medical centers must verify 
annually in January of each calendar year with FDA that an eye bank or 
tissue bank has complied with the FDA registration requirements of 21 
CFR Part 1271 before permitting an eye bank or tissue bank to receive 
protected health information.

(Authority: 38 U.S.C. 5701(k), 7332(b)(2)(E))

[FR Doc. E7-16648 Filed 8-22-07; 8:45 am]
BILLING CODE 8320-01-P