Rule2022-10764
Transplant Procedures With Live Donors and Related Care and Services
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 1, 2022
Effective
July 1, 2022
Issuing agencies
Veterans Affairs Department
Abstract
The Department of Veterans Affairs (VA) adopts as final, with changes, a proposed rule amending its medical regulations to implement legislation providing it stand-alone authority to provide procedures to remove a solid organ or bone marrow from a live donor for transplantation into a veteran and to furnish the live donor care or services before and after the procedure required in connection with the veteran's transplantation procedure. This rulemaking implements the mandates of section 153 of the VA MISSION Act of 2018.
Full Text
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<title>Federal Register, Volume 87 Issue 105 (Wednesday, June 1, 2022)</title>
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[Federal Register Volume 87, Number 105 (Wednesday, June 1, 2022)]
[Rules and Regulations]
[Pages 33021-33025]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-10764]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AQ65
Transplant Procedures With Live Donors and Related Care and
Services
AGENCY: Department of Veterans Affairs.
ACTION: Final rule.
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SUMMARY: The Department of Veterans Affairs (VA) adopts as final, with
changes, a proposed rule amending its medical regulations to implement
legislation providing it stand-alone authority to provide procedures to
remove a solid organ or bone marrow from a live donor for
transplantation into a veteran and to furnish the live donor care or
services before and after the procedure required in connection with the
veteran's transplantation procedure. This rulemaking implements the
mandates of section 153 of the VA MISSION Act of 2018.
DATES: This rule is effective July 1, 2022.
FOR FURTHER INFORMATION CONTACT: Mani Murugavel, DNP, NE-BC, CSSGB, RN,
National Director, Clinical Services, National Surgery Office (11SURG),
Veterans Health Administration, 810 Vermont Avenue NW, Washington, DC
20420, (202) 461-7130. (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: In a document published in the Federal
Register (FR) on March 24, 2021, (86 FR 15628), VA proposed to amend
its medical regulations to implement its authority to provide
procedures to remove a solid organ or bone marrow from a live donor for
transplantation into a veteran and to furnish the live donor care or
services before and after the procedure. VA provided a 60-day comment
period, which ended on May 24, 2021. Six comments were received.
Comments
The six comments were generally supportive of the proposed rule,
and we thank the commenters for their comments. Of those six comments,
four included substantive feedback, which is discussed below.
One commenter opined that live donors should be further
compensated. This commenter suggested VA cover additional expenses that
are deemed necessary and for which live donors submit documentation, as
there are ``other factors such as emotional effects that donors
sometime[s] experience'' due to the transplant procedure. However, this
commenter did not specify the types of additional expenses VA should
cover.
As explained in the proposed rule, VA will cover for the live donor
hospital care and medical services prior to the surgical removal of the
solid organ, part of a solid organ, or bone marrow; the surgical
procedure to remove a solid organ, part of a solid organ, or bone
marrow, and related care; and follow-up care which varies based on the
type of donation. Additionally, VA will cover travel costs, including
temporary lodging as VA determines to be needed. While VA acknowledges
that live donors may incur additional expenses, VA believes the
services and expenses covered under this rulemaking are reasonable
under section 1788 of title 38, United States (U.S.C.), are consistent
with how VA has administered the transplant program to date, and
recognize the sacrifices that live donors make. While VA understands
the commenter's support and rationale for expanding upon the additional
expenses covered by VA, VA is not making any changes based on this
comment.
To the extent that this commenter further suggested that live
donors should be compensated for their donation, by law, VA may not
knowingly acquire, receive, or otherwise transfer any human organ for
valuable consideration for use in human transplantation if the transfer
affects interstate commerce. 42 U.S.C. 274e(a). For purposes of this
statute, the term ``valuable consideration'' ``does not include the
reasonable payments associated with the removal, transportation,
implantation, processing, preservation, quality control, and storage of
a human organ or the expenses of travel, housing, and lost wages
incurred by the donor of a human organ in connection with the donation
of the organ.'' Section 274e(c)(2). Although this prohibition does not
apply to a ``human organ paired donation,'' (see last sentence of
section 274e(a)), that is not to say that compensation is available in
these cases, because the term ``human organ paired donation,'' as
defined in section 274e(c)(4), clearly bars valuable consideration from
being provided for the organ in subparagraph (c)(4)(F). Thus,
furnishing compensation for a human organ is legally barred. In
addition, a host of ethical questions are raised by such a proposal.
Transplant programs participating in the Organ Procurement
Transplantation Network (OPTN) are authorized, however, to provide
reimbursement for incidental non-medical expenses of donors. See 42
U.S.C. 274f, as implemented by Sec. 121.14 of title 42, Code of
Federal Regulations (CFR). This authority is discretionary, and while
VA voluntarily participates and complies with OPTN requirements and is
an OPTN-designated transplant program, VA will cover only the non-
medical costs we have identified, as these types of non-medical costs
are directly integral to the donor's transplant episode. In addition,
this aligns with how very limited non-medical care benefits, or
financial incentives, exist for other VA beneficiaries. Nonetheless, VA
will undertake additional review and analysis to determine whether non-
medical expenses other than those already covered under this rulemaking
should be covered to encourage greater
[[Page 33022]]
donor participation. If VA determines additional non-medical expenses
such as incidental non-medical costs described in 42 CFR 121.14 should
also be covered, it will propose to do so in a separate future
rulemaking.
VA therefore makes no changes based on this comment.
Another commenter stated that it was unclear whether the definition
of kidney paired donation, in 38 CFR 17.395(b), included living donor
chains, and suggested VA modify this definition to explicitly cover
living donor chains. As explained in OPTN policies, a living (or live)
donor chain is an approach in which a live donor without an intended
recipient donates an organ, which is matched with a recipient. See
OPTN, Policy 1: Administrations Rules and Definitions, and Policy 13:
Kidney Paired Donation. U.S. Department of Health and Human Services,
Health Resources and Services Administration. Retrieved from: <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/optn_policies.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/optn_policies.pdf</a> (Accessed: 25 October 2021). That recipient's
prospective live donor then donates an organ that can be matched with
another recipient. Id. A chain of donations then occurs that allows for
the donation and receipt of compatible organs. Id. Currently, live
donor chains are widely used for the donation and receipt of kidneys.
The definition of kidney paired donation in Sec. 17.395(b) is
consistent with OPTN's definition of kidney paired donation. However,
it does not specifically address live donor chains nor does it prohibit
live donor chains. For the purposes of this rulemaking, VA clarifies
that live donor chains are permitted, and interpreted to be included,
under VA's definition of kidney paired donation. Based on this comment,
VA is adding a note to the definition of kidney paired donation to
state that for purposes of this section, kidney paired donation
includes live donor chains. VA is also adding a definition for live
donor chain to mean a set of kidney paired donation matches that begins
with a donation of a kidney from a live donor without an intended
recipient. Such live donor donates a kidney for transplantation into
the intended recipient of a prospective live donor. The prospective
live donor then donates a kidney for transplantation into a recipient
other than the intended recipient. A chain continues to allow donation
and receipt of compatible kidneys. VA makes no further changes based on
this comment.
One commenter suggested that VA revise its rule to specify that VA
bone marrow programs follow standards of care and patient safety issued
by the nation's bone marrow registry, as they opined that it is
critical VA and non-VA bone marrow programs align. This commenter noted
that National Marrow Donor Program (NMDP) network members are held to
standards of care and safety for bone marrow transplant similar to OPTN
members.
As an initial matter, NMDP manages a bone marrow registry in which
donors unrelated to the transplant recipient can voluntarily register
to donate their bone marrow (including stem cells). These donations are
then stored and managed by NMDP. While medical hospitals and facilities
can become NMDP-contracted bone marrow donor centers, which are subject
to NMDP Donor Center participation standards, VA does not have any such
bone marrow donor centers as part of its bone marrow transplantation
program. Instead, VA contracts with NMDP to obtain bone marrow for
transplantation when a bone marrow match is identified (through NMDP's
registry) for a veteran recipient. VA also may obtain bone marrow
directly from live donors who are identified by VA as a match for the
veteran recipient.
To the extent that this commenter is suggesting VA revise the rule
to specify that VA's bone marrow program follows standards of care and
patient safety issued by NMDP for live donors of bone marrow, NMDP
maintains standards for bone marrow donor centers, specifically related
to the bone marrow donor. Because VA does not operate NMDP-contracted
bone marrow donor centers, related NMDP standards do not apply to VA.
When VA procures bone marrow including stem cells from NMDP for
transplantation into a veteran recipient, VA does not directly interact
with the bone marrow donor and thus any standards about donor care
would be inapplicable, particularly as VA would not know the identity
of the live donor. Therefore, NDMP donor center participation standards
do not apply to VA's bone marrow transplantation program because VA
does not operate such donor centers. As noted earlier, VA may obtain
bone marrow directly from live donors (for example, family members of
the veteran) who are identified by VA as a match for the veteran
recipient; however, such donations do not fall under NMDP standards for
donor centers. VA believes the current language in the regulation
regarding care for bone marrow donors is sufficient, particularly as it
is consistent with VA current policy and practices. VA does not make
any changes to the regulation based on this comment.
NMDP also maintains standards, including data reporting, relating
to the unrelated allogeneic bone marrow transplant procedure. VA
voluntarily complies with such standards. To the extent that this
commenter is suggesting VA revise the rule to specify that VA's bone
marrow program follows standards of care and patient safety issued by
NMDP for transplant recipients, VA considers this outside the scope of
the rulemaking as this relates to transplant recipients, not live
donors. VA makes no changes to the regulation based on this comment.
That same commenter also suggested the rule be revised to specify
that data reporting requirements for bone marrow transplant be
submitted to the Stem Cell Therapeutic Outcomes Database (SCTOD), as
that ``database allows analysis of program use, center-specific
outcomes, size of donor registry and cord blood inventory, and patient
access to hematopoietic cell transplantations, and per the Stem Cell
Therapeutic and Research Act of 2005, VA would share outcomes data with
the SCTOD.''
VA voluntarily complies with the Foundation for the Accreditation
of Cellular Therapy (FACT) standards for direct allogeneic live donor
care and data reporting requirements. These include submission of
direct allogeneic stem cell transplant data to the SCTOD. However, VA
considers this part of the comment beyond the scope of the rulemaking
as these reporting requirements for bone marrow transplant mainly
concern the engraftment and recipient, and not the live donor, and this
comment does not pertain to the care and services available to live
donors under VA's transplant program. VA believes that this is more
appropriate for internal VA policy than regulation since it concerns
internal VA requirements. To the extent that this commenter is
suggesting non-VA providers performing bone marrow transplants under
VA's transplant program comply with these same data reporting
requirements, this is beyond the scope of this rulemaking and would be
more appropriate for inclusion in agreements VA enters into with these
non-VA providers. VA is making no changes based on this comment.
One commenter stated that OPTN requires that transplant programs
only use living donor organs recovered from OPTN approved living donor
recovery hospitals and noted that when VA enters into agreements with
non-VA facilities for organ transplants, it should ensure that these
non-VA facilities are approved for recovery of organs from living
donors if the recovery will occur in such facilities. This commenter
[[Page 33023]]
suggested VA consider clarifying in the final rule the minimum
requirements for these non-VA facilities that recover organs from
living donors. Relatedly, this commenter recommended the rule be
``explicit about requirements for outcomes reporting, compliance
monitoring, and other considerations between bone marrow and solid
organ transplant, given their distinct contractual relationships with
the federal government.''
With regards to the comment that VA should ensure that non-VA
facilities with which VA enters into agreements for bone marrow or
solid organ transplants are approved by OPTN, VA considers this part of
the comment beyond the scope of the rulemaking since it does not
pertain to the care and services available to live donors under VA's
transplant program. The qualifications that VA requires non-VA
facilities providing such services to possess is a separate matter that
will be addressed by VA in the context of its acquisitions.
In the agreements VA would enter into with non-VA facilities for
organ transplants, VA would ensure that the appropriate requirements,
such as those requirements for outcomes reporting, compliance
monitoring, and other requirements or considerations, are included in
such agreements. This information is commonly set forth in agreements
rather than regulations, especially to permit flexibility, as
requirements are subject to change. Additionally, the purpose of this
rulemaking is to regulate the care and services available to living
donors before and after the procedure required in connection with a
veteran's transplantation procedure; not to regulate the requirements
for reporting, monitoring, or other similar requirements with which
non-VA providers must comply.
VA is making no changes based on this comment.
Technical Changes Not Based on Comments
VA makes two technical changes not based on comments. Both
technical changes are made to 38 CFR 17.395(g), which states the
limitations on VA obligations in kidney paired donations. The first
change is to replace the term, care, with the term, hospital care, in
the introductory paragraph of Sec. 17.395(g). The second change is to
replace the term, services, with the term, medical services, in the
introductory paragraph of Sec. 17.395(g). These technical changes
clarify the specific type of care and services referenced in Sec.
17.395(g) and are consistent with how these terms are used in paragraph
(c) of Sec. 17.395. These technical changes will also avoid potential
confusion with the terms, non-hospital care and non-medical services,
which appear in paragraph (d) of Sec. 17.395.
Based on the rationale set forth in the proposed rule and in this
final rule, VA is adopting the proposed rule with changes as noted.
Executive Orders 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.
The Office of Information and Regulatory Affairs has determined that
this rule is not a significant regulatory action under Executive Order
12866. The Regulatory Impact Analysis associated with this rulemaking
can be found as a supporting document at <a href="http://www.regulations.gov">www.regulations.gov</a>.
Regulatory Flexibility Act
The Secretary hereby certifies that this 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). VA has determined that this rule will not have a significant
impact on a substantial number of small entities because the final rule
does not directly regulate or impose costs on small entities and any
effects would be indirect. Therefore, pursuant to 5 U.S.C. 605(b), the
initial and final regulatory flexibility analysis requirements of 5
U.S.C. 603 and 604 do not apply.
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 final rule will have no such effect on
State, local, and tribal governments, or on the private sector.
Paperwork Reduction Act
This final rule contains no provisions constituting a collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521).
Assistance Listing
The Assistance Listing numbers and titles for the programs affected
by this document are 64.009, Veterans Medical Care Benefits; 64.029,
Purchased Care Program; 64.047, VHA Primary Care; 64.042, 64. 045, VHA
Ancillary Outpatient Services; 64.042, VHA Inpatient Surgery; 64.040,
VHA Inpatient Medicine; 64.041,VHA Outpatient Specialty Care; 64.035,
Veterans Transportation Program.
Congressional Review Act
Pursuant to Subtitle E of the Small Business Regulatory Enforcement
Fairness Act of 1996 (known as the Congressional Review Act) (5 U.S.C.
801 et seq.), the Office of Information and Regulatory Affairs
designated this rule as not a major rule, as defined by 5 U.S.C.
804(2).
List of Subjects in 38 CFR Part 17
Administrative practice and procedure, Alcohol abuse, Alcoholism,
Claims, Day care, Dental health, Drug abuse, Foreign relations,
Government contracts, Grant programs-health, Grant programs-veterans,
Health care, Health facilities, Health professions, Health records,
Homeless, Medical and dental schools, Medical devices, Medical
research, Mental health programs, Nursing homes, Philippines, Reporting
and recordkeeping requirements, Scholarships and fellowships, Travel
and transportation expenses, Veterans.
Signing Authority
Denis McDonough, Secretary of Veterans Affairs, approved this
document on March 7, 2022, 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.
Consuela Benjamin,
Regulation Development Coordinator, Office of Regulation Policy &
Management, Office of General Counsel, Department of Veterans Affairs.
For the reasons stated in the preamble, the Department of Veterans
Affairs amends 38 CFR part 17 as set forth below:
PART 17--MEDICAL
0
1. The general authority citation for part 17 continues and an
authority
[[Page 33024]]
citation for Sec. 17.395 is added in numerical order to read as
follows:
Authority: 38 U.S.C. 501 and as noted in specific sections.
* * * * *
Section 17.395 is also issued under 38 U.S.C. 1788.
0
2. Add an undesignated center heading and Sec. 17.395 to read as
follows:
Hospital Care, Medical Services, and Other Services for Live Donors
Sec. 17.395 Transplant procedures with live donors, and related
services.
(a) Scope. This section provides for medical and non-medical care
and services of persons who volunteer to donate a solid organ, part of
a solid organ, or bone marrow for transplantation into an eligible
veteran transplant candidate, irrespective of a donor's eligibility to
receive VA health care for any reason other than to donate a solid
organ, part of a solid organ, or bone marrow. It prescribes the type,
timing, and duration of hospital care and medical services VA provides,
including medical care or services purchased by agreement from a non-VA
facility. It also provides for non-medical care and services essential
to the prospective live donor's or live donor's participation and for
VA reimbursement for that care and services. The section does not
provide for eligible veteran transplant candidates' VA medical
benefits.
(b) Definitions. For purposes of this section:
Initial prospective live donor means an intended recipient's
prospective live donor who volunteers to donate a kidney to a recipient
other than the intended recipient through kidney paired donation.
Intended recipient means the transplant candidate who VA identifies
to receive a live donor's solid organ, part of a solid organ, or bone
marrow.
Kidney paired donation means one prospective live donor's voluntary
donation of a kidney for transplantation into a recipient other than an
intended recipient, paired with the transplantation into the intended
recipient of a compatible kidney from a different live donor. Note: For
purposes of this section, kidney paired donation includes live donor
chains.
Live donor means an individual who is:
(i) Medically suitable for donation;
(ii) Is a compatible match to an identified veteran transplant
candidate; and
(iii) Has provided informed consent to undergo elective removal of
one solid organ, part of a solid organ, or of bone marrow.
Live donor chain means a set of kidney paired donation matches that
begins with a donation of a kidney from a live donor without an
intended recipient. Such live donor donates a kidney for
transplantation into the intended recipient of a prospective live
donor. The prospective live donor then donates a kidney for
transplantation into a recipient other than the intended recipient. A
chain continues to allow donation and receipt of compatible kidneys.
Live Donor Follow-Up Means
(i) For live donors of a solid organ or part of a solid organ, the
collection of clinically relevant post-donation live donor data and the
provision of recommended clinical laboratory tests and evaluations
consistent with Organ Procurement and Transplantation Network policy,
and the provision of direct medical care required to address reasonably
foreseeable donor health complications resulting directly from the
donation procedure.
(ii) For live donors of bone marrow, the provision of direct
medical care required to address reasonably foreseeable donor health
complications resulting directly from the donation procedure.
Prospective live donor means a person who has volunteered to donate
a solid organ, part of a solid organ, or bone marrow to an intended
recipient, and who has agreed to participate in any activity VA deems
necessary to carry out the intended recipient's transplant procedure.
Transplant candidate means an enrolled veteran or a veteran
otherwise eligible for VA's medical benefits package who VA determines
has a medical need for a solid organ, part of a solid organ, or bone
marrow transplant.
Transplant recipient means a transplant candidate who has undergone
transplantation and received a solid organ, part of a solid organ, or
bone marrow from a live donor.
(c) Hospital care and medical services. To obtain a solid organ,
part of a solid organ, or bone marrow for a VA transplant candidate, VA
may provide the following hospital care and medical services to a
prospective live donor or live donor:
(1) Before removal of a solid organ, part of a solid organ, or bone
marrow, VA will provide examinations, tests, and studies necessary to
qualify a prospective live donor to donate a solid organ, part of a
solid organ, or bone marrow.
(2) During removal of a solid organ, part of a solid organ, or bone
marrow, VA will provide the surgical procedure to remove a solid organ,
part of a solid organ, or bone marrow from the living donor whose solid
organ, part of a solid organ, or bone marrow will be transplanted into
an intended recipient.
(3) After removal of a solid organ or part of a solid organ, VA
will provide all hospital care, medical services, and other services
which are necessary and appropriate to live donor follow-up as defined
in paragraph (b) of this section for a period not less than that which
the Organ Procurement and Transplantation Network prescribes or
recommends or for a period of 2 years, whichever is greater.
(4) After bone marrow removal, VA will provide direct medical care
required to address reasonably foreseeable live donor health
complications resulting directly from the bone marrow donation
procedure for a period not greater than 2 years.
(5) A prospective live donor who is also a veteran enrolled in VA's
health care system may receive care and services authorized in
paragraphs (c)(1) and (2) only under this section. A live donor who is
also a veteran enrolled in VA's health care system may opt to receive
the care and services authorized under paragraph (c)(3) or (4) under
either the medical benefits package codified at Sec. 17.38 or under
this section, but not both at the same time.
(d) Non-hospital care and non-medical services. If VA determines
the prospective live donor's or the live donor's presence or proximity
is necessary, VA will reimburse the travel costs of the prospective
live donor or live donor, including one needed attendant or support
person, at the rates provided in Sec. 70.30 of this chapter, without
the deductibles required by Sec. 70.31 of this chapter, for:
(1) Travel between the prospective live donor's or live donor's
residence and the site of hospital care or medical services authorized
in paragraph (c) of this section; and
(2) Temporary lodging:
(i) While the live donor is hospitalized for the organ removal
procedure; or
(ii) While the prospective live donor's or live donor's
participation in the live donor program requires the prospective live
donor's or live donor's presence away from home at least overnight and
the prospective live donor's or live donor's presence or proximity is
determined necessary by VA.
(e) Use of non-VA facilities and non-VA service providers. (1) If
and only if VA and a non-VA facility or non-VA
[[Page 33025]]
service provider have an agreement governed by 38 U.S.C. 8153 or any
other applicable authority in title 38, United States Code, a non-VA
facility may provide--
(i) A surgical procedure and care and services described in
paragraph (c) of this section; or
(ii) Non-hospital care or non-medical services described and
otherwise reimbursable under paragraph (d) of this section.
(2) The prospective live donor or live donor is eligible for
hospital care and medical services, or travel services, at a non-VA
facility solely for the procedure, care, and services described in
paragraphs (c) and (d) of this section as governed by an agreement
described in paragraph (e)(1) of this section.
(f) Participation terminated without completion of the intended
recipient's transplantation procedure. (1) VA will provide the
prospective live donor or live donor the care and services described in
this section for any VA-authorized participation in the intended
recipient's organ or bone marrow transplantation process even if the
transplantation procedure for which the prospective live donor or live
donor volunteered to donate a solid organ, part of a solid organ, or
bone marrow is not completed.
(2) A prospective live donor or a live donor may withdraw his or
her informed consent at any time and for any reason. In the case of
revocation of consent, VA will pay all the costs authorized under this
section for the prospective live donor or live donor up until when the
donor revokes consent and ends his or her participation.
(g) Limitation on VA obligation in kidney paired donations. In
kidney paired donations, VA's obligation to provide any procedure,
hospital care, or medical services under this section extends:
(1) To the initial prospective live donor who elects to participate
in a kidney paired donation matching program, but only for the
examinations, tests, and studies described in paragraph (c)(1) of this
section for a prospective live donor before kidney removal.
(2) To the live donor whose kidney the intended recipient will
receive or has received but only for the services described in
paragraphs (c)(2) and (3) of this section.
[FR Doc. 2022-10764 Filed 5-31-22; 8:45 am]
BILLING CODE 8320-01-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.