[Federal Register Volume 84, Number 245 (Friday, December 20, 2019)]
[Proposed Rules]
[Pages 70139-70145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27532]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 121
RIN 0906-AB23
Removing Financial Disincentives to Living Organ Donation
AGENCY: Health Resources and Services Administration (HRSA).
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Department of Health and Human Services (HHS) proposes to
amend the regulations implementing the National Organ Transplant Act of
1984, as amended (NOTA), to remove financial barriers to organ donation
by expanding the scope of reimbursable expenses incurred by living
organ donors to include lost wages and child-care and elder-care
expenses incurred by a primary care giver. HHS is committed to reducing
the number of individuals on the organ transplant waiting list by
increasing the number of organs available for transplant. This proposed
rule implements Section 8 of the Executive Order (E.O.) on Advancing
American Kidney Health, issued on July 10, 2019, which directs HHS to
propose a regulation allowing living organ donors to be reimbursed for
related lost wages, child-care expenses, and elder-care expenses
through the Reimbursement of Travel and Subsistence Expenses Incurred
toward Living Organ Donation program.
DATES: Written comments and related material to this proposed rule must
be received to the online docket via www.regulations.gov, or to the
mail address listed in the ADDRESSES section below, on or before
February 18, 2020.
ADDRESSES: You may submit comments on this proposed rule identified by
HHS Docket No. HRSA-2019-0001, by any one of the following methods:
[ssquf] Federal eRulemaking Portal (preferred):
www.regulations.gov. Follow the website instructions for submitting
comments.
[ssquf] Mail: Alford Danzy, Regulations Officer, Executive
Secretariat, Health Resources and Services Administration, 5600 Fishers
Lane, Rockville, Room 13N82, MD 20857. To ensure proper handling,
please reference HHS Docket No. HRSA-2019-0001 in your correspondence.
Mail must be postmarked by the comment submission deadline.
FOR FURTHER INFORMATION CONTACT: Frank Holloman, Director, Division of
Transplantation, Healthcare Systems Bureau, HRSA, 5600 Fishers Lane,
Room 08W63, Rockville, MD 20857; by
[[Page 70140]]
email at [email protected]; or by telephone (301) 443-7577.
SUPPLEMENTARY INFORMATION:
I. Public Participation
All interested parties are invited to participate in this
rulemaking by submitting written views, comments and arguments on all
aspects of this proposed rule, as well as additional data that should
be considered. HHS also invites comments that relate to the economic,
legal, environmental, or federalism effects that might result from this
proposed rule. Comments that will provide the most assistance to HRSA
in implementing these changes will reference a specific portion of the
proposed rule, explain the reason for any recommended change, and
include data, information, or authority that supports such recommended
change.
Instructions: If you submit a comment, you must include the agency
name and the HHS Docket No. HRSA-2019-0001 for this rulemaking.
Regardless of the method used for submitting comments or material, all
submissions will be posted, without change, to the Federal eRulemaking
Portal at http://www.regulations.gov, and will include any personal
information you provide. Therefore, submitting this information makes
it public. You may wish to consider limiting the amount of personal
information that you provide in any voluntary public comment submission
you make to HHS. HHS may withhold information provided in comments from
public viewing that it determines may impact the privacy of an
individual or is offensive. For additional information, please read the
Privacy Act notice that is available via the link in the footer of
http://www.regulations.gov.
Docket: For access to the docket and to read background documents
or comments received, go to http://regulations.gov, referencing HHS
Docket No. HRSA-2019-0001. You may also sign up for email alerts on the
online docket to be notified when comments are posted or a final rule
is published.
II. Background and Purpose
As of January 2019, more than 113,000 men, women, and children were
on the national organ transplant waiting list. Every 10 minutes another
person is added to the waiting list, and approximately 20 people die
every day while waiting for a transplant.\1\ The current approach to
acquiring organs for transplantation relies on the altruism of deceased
donors and families and the voluntarism and altruism of living organ
donors. Living organ donation is an important option for thousands of
men, women, and children on the national transplant waiting list.
Transplants using organs from living donors accounted for 19 percent
(6,849) of the total (36,528) transplants performed in 2018.\2\
Transplants involving organs from deceased donors, who can provide
multiple organs, comprised the other 81 percent (29,680) of the 2018
total.\3\
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\1\ Information from https://www.organdonor.gov/statistics-stories/statistics.html#glance and accessed on August 26, 2019.
\2\ Data from optn.transplant.hrsa.gov and OPTN/SRTR Annual
Report.
\3\ Data from optn.transplant.hrsa.gov and OPTN/SRTR Annual
Report.
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Living organ donation offers a viable transplant option, primarily
for kidney and liver transplant candidates, and helps to reduce the
overall number of individuals on the deceased donor organ waiting list,
improving the transplantation system. The President's Executive Order
on Advancing American Kidney Health emphasized that supporting living
organ donors can help address the current demand for kidney
transplants. That Executive Order directed the HHS Secretary to propose
a regulation that would expand the definition of allowable costs that
can be reimbursed under HRSA's current Reimbursement of Travel and
Subsistence Expenses Incurred toward Living Organ Donation program.
This NPRM aligns with the aforementioned Executive Order, which also
included language to specifically allow for the reimbursement of lost
wages along with child-care and elder-care expenses.
Living organ donation also delivers a number of other benefits for
the recipient. The living organ donor transplant recipient can often
receive a better quality organ in a shorter time period, which often
results in lower rates of graft failure and improved survival rates for
organ recipients.\4\ In general, recipients of kidney transplants from
living organ donors have better clinical outcomes than those who
continue on dialysis or receive a deceased donor kidney transplant.\5\
Living organ donation also provides significant cost savings over the
course of a recipient's lifetime. In the first five years alone
following their transplants, projected return on investment (ROI) for
living donor financial assistance, relative to dialysis versus
transplant costs, has been shown to provide 5.1-fold ROI in year 1
rising up to 28.2-fold ROI in year 5, and produces $256.4 million in
savings against patients having remained on dialysis.\6\ Living organ
donations also deliver intangible benefits, such as the positive
feelings that can come with saving or improving the life of another
individual. All such benefits must be weighed against the donor risks,
which include surgical and anesthesia-related complications and
infections as well as the uncertainty of the long-term health effects
on donors following living organ donation, which are currently being
studied.
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\4\ Data from https://srtr.transplant.hrsa.gov/annual_reports/2017/Kidney.aspx.
\5\ Data from https://srtr.transplant.hrsa.gov/annual_reports/2017/Kidney.aspx.
\6\ Mathur AK et al. Return on investment for financial
assistance for living kidney donors in the United States. Clinical
Transplant. 2018;32:e13277. https://doi.org/10.1111/ctr.13277.
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According to the 2017 U.S. Scientific Registry of Transplant
Recipients (SRTR) Annual Data Report, between 4,400 and 5,000 adults
awaiting kidneys are removed from the national transplant waiting list
every year because they have died, and an additional 4,000 to 4,500 are
removed because they have become too sick to receive a transplant.\7\
As of 2016, there were over 500,000 individuals receiving dialysis
treatment, and over 200,000 lived with a kidney transplant.\8\ To date,
approximately 96,000 of these individuals are on the national waiting
list awaiting an available kidney.\9\ As such, the agency believes
regulatory changes designed to increase living organ donation, by
removing financial disincentives for living organ donors, such as those
proposed in this rule, could mitigate some of these tragic outcomes.
The agency further believes that this regulatory language, if finalized
as proposed, will encourage and allow for more potential living organ
donors to proceed to donation.
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\7\ Data obtained from https://srtr.transplant.hrsa.gov/annual_reports/2017/Kidney.aspx#KI_5_activity_adult_waiting.
\8\ Data obtained from https://www.kidney.org/news/newsroom/factsheets/KidneyDiseaseBasics.
\9\ Data obtained from https://optn.transplant.hrsa.gov/data/
and accessed on September 23, 2019.
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A. HRSA's Reimbursement of Travel and Subsistence Expenses Incurred
Toward Living Organ Donation Program
Congress provided specific authority under section 377 of the
Public Health Service (PHS) Act, as amended, 42 U.S.C. 274f,\10\ to the
Secretary of Health and Human Services (the Secretary) for
reimbursement of travel and subsistence expenses, which encompasses
costs for travel to medical and clinical appointments, lodging, and
meals, incurred by eligible individuals making living donations of
their organs, and
[[Page 70141]]
other individuals accompanying the living organ donors.
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\10\ Information obtained from https://www.govinfo.gov/content/pkg/PLAW-108publ216/pdf/PLAW-108publ216.pdf.
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Within the same section of the PHS Act, Congress also authorized
the Secretary to reimburse ``incidental non-medical expenses'' incurred
by living organ donors under 42 U.S.C. 274f(a)(2), if the Secretary
determines by regulation that reimbursements for such expenses is
appropriate.
The National Living Donor Assistance Center (NLDAC) is the living
donor reimbursement program (https://www.livingdonorassistance.org/home/default.aspx) funded by HRSA's Reimbursement of Travel and
Subsistence Expenses Incurred toward Living Organ Donation grant's
program. Pursuant to the authority provided under section 377 of the
PHS Act, as amended, in 2006 HRSA initially awarded a cooperative
agreement to the Regents of the University of Michigan, which partnered
with the American Society of Transplant Surgeons to establish the NLDAC
in order to operate a program to provide this type of reimbursement. In
May 2016, the cooperative agreement transferred to the University of
Arizona and in 2019, a new award was granted to the University of
Arizona. The program's purpose is to help remove financial
disincentives for living organ donations. In adherence to the authority
outlined in the PHS Act, the Program Guidelines for NLDAC provide that
``qualifying expenses'' include those incurred by the donor and/or his/
her accompanying person(s) as part of: (1) Donor evaluation and/or (2)
hospitalization for the living donor surgical procedure, and/or (3)
medical or surgical follow-up, clinic visits, or hospitalization within
2 calendar years following the living donation procedure.\11\ It is
important to note that not all applicants or recipients of
reimbursements will go on to donate an organ. Many factors may prevent
an intended and willing donor from proceeding with the donation. Such
circumstances include present health status of the intended donor or
recipient that would prevent the transplant or donation from
proceeding, perceived long-term risks to the intended donor, or
unforeseen events outside the intended donor's control.
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\11\ NLDAC program guidelines are available at https://www.govinfo.gov/content/pkg/FR-2009-06-19/pdf/E9-14425.pdf.
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The criteria for reimbursement are based on the incomes of both the
recipient and potential living organ donor and include only the
aforementioned qualifying expenses. As such, NLDAC currently does not
reimburse other expenses incurred by the donor, such as lost wages or
child-care and elder-care expenses. Under federal law, the NLDAC cannot
reimburse any living organ donor for travel and other qualifying
expenses if the donor can be reimbursed for these expenses from any of
the following sources: (1) Any state compensation program, an insurance
policy, or any federal or state health benefits program; (2) an entity
that provides health services on a prepaid basis; or (3) the recipient
of the organ. HRSA notes that some living organ donors may receive
assistance from other sources, such as private insurers' programs;
however, HRSA's reimbursement program specifically aims to assist
lower-income donors who lack other forms of financial support. The
Program was designed to be the payer of last resort and does not
provide funds as a gift or reward to individuals for being a donor.
As intended by HRSA and in compliance with the authorizing
legislation, NLDAC prioritizes lower-income donors who are highly
unlikely to secure funds for non-medical donation-related expenses from
any other sources, and excluded donors when the recipients could
reasonably be expected to pay for such expenses. From September 1,
2014, to January 31, 2019, NLDAC received and processed over 3,300
applications, approving nearly 2,900 (87.5 percent). Over that 5-year
period, the median household income of NLDAC donors and recipients was
$35,229 and $27,519, respectively. The average NLDAC reimbursement in
fiscal year 2018 was $1,934 per donor among 1,055 donor applications.
Currently, the median household incomes of NLDAC donors and
recipients both fall below the 40th percentile of American
households.\12\ The strongest evidence that NLDAC is meeting the needs
of donors facing financial barriers to donation is demonstrated by data
supplied by the current grantee showing that the median household
income among NLDAC donors in fiscal year 2018 was $35,463, which is
significantly lower than that for other U.S. donors $46,870.
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\12\ According to the 2013-2017 U.S. Census Bureau American
Community Survey 5-Year Estimates, the median household income is
$57,652. Data is available at https://www.census.gov/programs-surveys/acs/.
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If these changes are finalized as proposed, based on preliminary
information provided by the grantee, the agency projects a four to six-
fold increase in the number of applicants to the NLDAC. The agency also
projects that there would be a subsequent increase in the number of
transplants facilitated by NLDAC, commensurate with appropriated
funding levels and recipient eligibility guidelines.
The Secretary has not previously determined by regulation that
reimbursement for any categories of ``incidental non-medical expenses''
incurred by living organ donors toward their living organ donations may
appropriately be provided. If these regulatory changes become final,
the agency would amend the Program's Guidelines to reflect inclusion of
the specified additional expenses determined to be appropriate for
reimbursement.
B. Executive Order 13879: Advancing American Kidney Health
In the E.O on Advancing American Kidney Health, issued on July 10,
2019, the President directed HHS to propose a regulation to allow
living donors to be reimbursed for related lost wages, child-care
expenses, and elder-care expenses through the Reimbursement of Travel
and Subsistence Expenses Incurred toward Living Organ Donation program
authorized by 42 U.S.C. 274f. This proposed rule fulfills the
President's mandate.
The E.O. further directed HHS to propose a raise to the limit on
the income of living donors eligible for reimbursement under the
program. The limit on donor income is set through the reimbursement
program's Eligibility Guidelines. HRSA is proposing a revision to the
Eligibility Guidelines and is considering increasing the upper
threshold for living organ donor and organ recipient household income.
HRSA will seek public comment on this planned revision to the
Eligibility Guidelines through a separately published Federal Register
notice. Therefore, this proposed rule does not address that aspect of
the Executive Order. HRSA will further revise the Eligibility
Guidelines to reflect any changes to the reimbursement program made
through this rulemaking process.
C. Advisory Committee on Organ Transplantation Recommendations
Section 121.12 of the OPTN Final Rule established the Advisory
Committee on Organ Transplantation (ACOT). ACOT advises and provides
recommendations to the Secretary through HRSA on:
All aspects of organ donation, procurement, allocation,
and transplantation, and on such other matters that the Secretary
determines;
federal efforts to maximize the number of deceased donor
organs made available for transplantation and to support the safety of
living organ donation;
[[Page 70142]]
the latest advances in the science of transplantation;
and,
at the request of the Secretary, significant proposed OPTN
policies submitted for the Secretary's approval to recommend whether
they should be made enforceable.
In May 2019, ACOT voted to provide recommendations to the Secretary
which, if adopted, would increase access to organs from living organ
donors by providing living donors with additional support and resources
and by removing disincentives that may have prevented potential donors
from donating. Two of these recommendations are:
Encourage a permanent mechanism for lost wages
reimbursement for non-directed living donors in conjunction with the
travel and subsistence costs.
Amend current guidelines to improve reimbursement so that
it includes reimbursement for living donors' child-care and elder-care
expenses in addition to travel and subsistence costs.
D. Section 301 of NOTA
Reimbursement payments received via NLDAC must not violate section
301 of NOTA, which makes it ``unlawful for any person to knowingly
acquire, receive, or otherwise transfer any human organ for valuable
consideration for use in human transplantation if the transfer affects
interstate commerce,'' as described in 42 U.S.C. 274e(a). Thus, section
301 of NOTA outlaws the purchase and sale of organs. Certain expenses
are specifically excluded from the scope of valuable consideration,
including ``expenses of travel, housing, and lost wages incurred by the
donor of a human organ in connection with the donation of the organ.''
42 U.S.C. 274e(c)(2). Section 301 of NOTA does not expressly say
whether child-care or elder-care expenses incurred by a donor in
connection with the donation constitute prohibited ``valuable
consideration.'' HHS has determined, and the U.S. Department of
Justice, Office of Legal Counsel, concurred, that the reimbursement of
child-care and elder-care expenses as described here are not valuable
consideration under section 301 of NOTA. Therefore, this prohibition
does not pose a barrier to the Secretary determining by regulation that
the reimbursement of such expenses is appropriate under the authority
provided by 42 U.S.C. 274f(a)(2).
III. Discussion of Proposed Rule
Abstract research data showed that, when asked, 75.6 percent of
living donors who received NLDAC funds stated that they would not have
been able to donate a kidney without the financial assistance provided
by the program.\13\ In line with this finding, the Agency believes that
there are many potential living organ donors who would like to donate
an organ to a family member or friend, but cannot afford the loss of
income incurred during the required weeks out of work needed for the
transplant surgery and recovery time. The extended recovery time can
also adversely impact potential donors who are the primary caregivers
for children and/or elderly family members. Potential donors can face
challenges paying for indirect expenses related to transplantation not
covered by insurance. Overall, the costs of the process can be a burden
for donors and recipients; for some, these costs make living organ
donation unlikely or even impossible.
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\13\ Merion RM et al. Analysis of dialysis cost and median
waiting time on return on investment (ROI) of the US National Living
Donor Assistance Center (NLDAC) program [abstract]. Transplantation.
2016;100:S310.
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HRSA's reimbursement program, which is operated through NLDAC, does
not currently reimburse lost wages or child-care or elder-care
expenses. As previously discussed, section 301 of NOTA is not a barrier
to the Secretary determining, by regulation, that such expenses may be
reimbursed. Accordingly, HRSA is proposing to remove barriers and
disincentives to living organ donation by amending the OPTN Final Rule
to formally add lost wages child-care and elder-care expenses incurred
by primary caregivers as reimbursable expenses for living organ donors.
This rule, if finalized as proposed, will constitute the Secretary's
determination by regulation that reimbursement may be appropriately
provided for lost wages, and child-care and elder-care expenses
incurred by primary caregivers who make living donations of their
organs, as authorized by section 377(a)(2) of the PHS Act. HRSA
proposes adding a new regulatory section at Sec. 121.14 to list the
categories of ``incidental non-medical expenses'' that the Secretary
has determined are appropriate for reimbursement.
The other criteria of HRSA's reimbursement program, as provided in
the program's Eligibility Guidelines, remain applicable and will still
need to be met for reimbursement to be provided to living donors and
other individuals evaluated for living organ donation for lost wages
and child-care and elder-care expenses incurred by primary caregivers
while making donations of their organs. Once the final rule is
published, HRSA will revise the Eligibility Guidelines to specifically
address reimbursement criteria for these reimbursable expenses.
A. Lost Wages
Many potential living organ donors may be willing and available to
donate an organ to a family member, friend, or an unknown recipient,
but would be unable to afford the loss in income while out of work
during the transplant process, which includes the pre-transplant
evaluation, surgery, subsequent recovery time, and follow-up
appointments. This proposed rule would remove this potential barrier to
living organ donations. In amending the OPTN Final Rule, HRSA proposes
determining lost wages as an appropriate reimbursable expense for
living organ donors, and adding lost wages as a category of
reimbursable incidental non-medical expenses at Sec. 121.14(a)(1).
B. Child-Care Expenses and Elder-Care Expenses
Included among the many costs associated with living organ donation
are, for many individuals, the costs of child-care and elder-care. Such
costs can be incurred throughout the organ donation process, from the
transplant pre-evaluation through the hospital stay, during the
recovery period, and while the living donor attends necessary follow-up
medical appointments. This proposed rule would remove financial
barriers to living organ donation by expanding allowable reimbursements
to include child-care and elder-care expenses. Through this proposed
rule, HRSA proposes determining that child-care and elder-care expenses
incurred by primary caregivers are appropriate reimbursable expenses
for living organ donors, and adding child-care expenses at Sec.
121.14(a)(3) and elder-care expenses at Sec. 121.14(a)(4) as
categories of reimbursable incidental non-medical expenses.
Additional Financial Barriers to Organ Donation
Similar to the consideration of the wages lost by a potential
living organ donor, HRSA is concerned about other financial barriers to
organ donation, including but not limited to challenges related to
employer-provided medical insurance benefits while out of work during
the transplant process, including pre-transplant donor evaluation,
donor surgery, and post-surgery recovery. These challenges could
include ``foregone medical insurance benefits,'' defined as the loss of
a wage supplement for medical insurance premiums provided by an
employer.
[[Page 70143]]
HRSA specifically seeks public comment on this descriptor and any
literature or evidence on additional financial barriers to organ
donation, including whether foregone medical insurance benefits pose a
significant barrier to organ donation. While HRSA is not proposing that
foregone medical insurance benefits are an appropriate reimbursable
expense for living organ donors in this rulemaking, we are interested
in public comment as to whether, in a future rulemaking, we should
consider any additional benefits as categories of reimbursable
incidental non-medical expenses.
IV. Statutory and Regulatory Requirements
A. Executive Orders 12866, 13563, and 13771: Regulatory Planning and
Review
HHS has examined the effects of this proposed rule as required by
E.O. 12866 on Regulatory Planning and Review (September 30, 1993), E.O.
13563 on Improving Regulation and Regulatory Review (January 8, 2011),
the Regulatory Flexibility Act (September 19, 1980, Pub. L. 96-354),
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), E.O. 13132 on
Federalism (August 4, 1999), and E.O. 13771 on Reducing Regulation and
Controlling Regulatory Costs (January 30, 2017).
E.O. 12866 and E.O. 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 supplements and
reaffirms the principles, structures, and definitions governing
regulatory review as established in E.O. 12866, which emphasizes the
importance of quantifying both costs and benefits, of reducing costs,
of harmonizing rules, and of promoting flexibility.
Section 3(f) of E.O. 12866 defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1) Having an
annual effect on the economy of $100 million or more in any one year,
or adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local, or tribal governments or communities (also
referred to as ``economically significant''); (2) creating a serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order. A regulatory impact
analysis must be prepared for major rules with economically significant
effects ($100 million or more in any 1 year), and a ``significant''
regulatory action is subject to review by the Office of Management and
Budget (OMB). This proposed rule has been determined to be a
significant regulatory action. Accordingly, the proposed rule has been
reviewed by OMB.
E.O. 13771 (January 30, 2017) requires that the costs associated
with significant new regulations ``to the extent permitted by law, be
offset by the elimination of existing costs associated with at least
two prior regulations.'' The designation of this rule, if finalized,
will be informed by public comments received; however, if finalized as
proposed, this rule would be neither regulatory nor deregulatory for
purposes of E.O. 13771. There are no additional costs; the proposed
rule, if finalized, will only change how HRSA expends the appropriated
funds.
Summary of Impacts
Research into similar legislative changes and changes to financial
incentives have demonstrated increases in organ donations; thus, the
agency estimates that these proposed regulatory changes will increase
the number of living organ transplants. The agency expects this
increase for two primary reasons. Studies have shown that reimbursement
measures have increased organ donations anywhere from 14 percent to 65
percent, depending on the particular circumstances of the study, and
secondly, donor income also appears to play a role in living organ
donor transplant rates.
While specific details vary, the country of Israel's move toward
reimbursing lost wages and providing other benefits yielded a 65
percent increase in kidney transplants from living donors.\14\ In the
United States, paying donation-related travel costs through NLDAC
increased the number of living donor kidney transplants by
approximately 14 percent,\15\ with a separate survey of NLDAC donors
revealing that 75 percent of donors would not have donated without
reimbursement.\16\ In addition, tax incentive legislation in New York
increased living kidney donations to non-family members by 52
percent.\17\ Finally, a study looking at longitudinal trends found that
income was strongly associated with donation, with higher rates of
donation observed in higher income populations and donation rates
declining among the lowest earners after the last recession.\18\
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\14\ Lavee, J., Ashkenazi, T., Stoler, A., Cohen, J., & Beyar,
R. (2012). Preliminary Marked Increase in the National Organ
Donation Rate in Israel Following Implementation of a New Organ
Transplantation Law. American Journal of Transplantation,13 (3),
780-785, 2012. doi:10.1111/ajt.12001.
\15\ Schnier, K.E., Merion, R.M., Turgeon, N., & Howard, D.
(2018). Subsidizing altruism in living organ donation. Economic
Inquiry, 56(1), 398-423.
\16\ Merion RM et al. Analysis of dialysis cost and median
waiting time on return on investment (ROI) of the US National Living
Donor Assistance Center (NLDAC) program [abstract]. Transplantation.
2016;100:S310.
\17\ Bilgel, F., & Galle, B. (2015). Financial incentives for
kidney donation: A comparative case study using synthetic controls.
Journal of Health Economics. 43, 103-117.
\18\ Gill, J., Dong, J., Rose, C., Johnston, O., Landsberg, D.,
& Gill, J. (2013). The effect of race and income on living kidney
donation in the United States. Journal of the American Society of
Nephrology. 24(11), 1872-1879.
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Currently, the United States averages approximately 6,500 living
organ donations per year. Determining how many of these, or any
additional, living organ donors will be eligible for the proposed
financial incentives involves the interplay of a number of factors, as
does calculating the cost of these incentives.
First, not all living donors will be eligible for these
reimbursements. As previously stated, the E.O. on Advancing American
Kidney Health also directed HHS to propose raising the limit on the
income of living donors eligible to be reimbursed under the program.
The income eligibility threshold is the first criterion in determining
whether a potential donor is eligible to receive reimbursement of
expenses incurred. Additionally, as previously outlined, NLDAC is to be
used as the payer of last resort and cannot reimburse qualifying
expenses if the living organ donor can be reimbursed for these expenses
through other means.
Second, not all program-eligible living organ donors will incur
expenses relating to each one of the new categories of reimbursements
(lost wages, child-care, elder-care) offered through the regulatory
change. Each donor's circumstances differ; some might request
reimbursement for all three types of added reimbursable expenses, some
for one or two, and some for none at all.
Third, donors' specific circumstances will determine the
reimbursable amounts. Individual wages differ, as do the type, level,
and amount of child-care and/or elder-care required to
[[Page 70144]]
compensate those donors who are caregivers.
Fourth, while living organ donors typically face a 4-6 week post-
surgical recovery time, individual recovery times will vary. Surgical
complications or personal health issues might slow that process, and
the physical demands of the donor's work (i.e., strenuous versus
sedentary) might dictate how quickly she or he can return to work.
Given these individual differences, HRSA is using median weekly
figures for each expense to estimate the expected costs per individual
of these regulatory changes. Please note that the lost wages category
correlates to a typical 40-hour work week, while child-care and elder-
care are extrapolated out to a full 7-day week, on the presumption that
caregivers will require assistance caring for children and the elderly
on the weekends as well.
Wages: $28 per hour \19\ for 40 hours per week is a weekly
average wage of $1,120 per week or $4,480-$6,720 over 4-6 weeks.
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\19\ Information from the U.S. Bureau of Labor Statistics and
available at https://www.bls.gov/news.release/empsit.nr0.htm.
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Child-care: At $420 per full week \20\ child-care will
cost $1,680-$2,520 over 4-6 weeks.
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\20\ National Center for Education Statistics and available at
https://nces.ed.gov/programs/digest/d18/tables/dt18_202.30c.asp.
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Elder-care: At $504 per full week \21\ elder-care will
cost $2,016-$3,024 over 4-6 weeks.
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\21\ Paying for senior care, https://www.payingforseniorcare.com/longtermcare/costs.html#Non-Medical-Home-Care.
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Funding for this program is a fixed amount that is determined
through annual federal discretionary appropriations. These regulatory
changes will result in expanded coverage and a potential increase in
user demand of the living organ donor reimbursement program. Expanding
the list of eligible expenses could increase the average reimbursement.
The number of individuals receiving reimbursement and/or the amount of
reimbursements per individual in any given fiscal year will be
dependent upon annual appropriations. Therefore, increases in the
average reimbursement without increases in appropriations could result
in fewer individuals being served by the program. Based on the
uncertainty of annual appropriation levels for the program, HRSA is
considering a range of methods to ensure the ongoing viability of this
program, such as a reimbursement cap.
In relation to caps on reimbursements, under current program
guidelines, NLDAC limits donors to a maximum of $6,000 for
reimbursement of solely travel and subsistence; a correlating
demonstration project, on lost wages, limits reimbursement of solely
lost wages to a maximum of $5,000; donors receiving reimbursements from
both programs are capped at receiving a combined maximum of $8,000. In
fiscal year 2018, the average NLDAC reimbursement was $1,934 per donor,
which is lower than the current cap level. HRSA may adjust the cap to
account for lost wages, child-care, and elder-care. HRSA acknowledges
that this cap may not cover the entirety of reimbursable expenses
incurred by some donors; however, this assistance does align with one
of the major goals of the reimbursement program: To reduce financial
disincentives and disparities, not to necessarily make donors whole
financially.
While expanding the list of expenses eligible for reimbursement for
living organ donors will increase the average amount of reimbursement,
the federal government can expect to save overall due to an increase in
additional organ transplants performed and the aversion of dialysis.
The costs/savings incurred by kidney transplantation vary by donor
type. One study using Medicare claims data \22\ estimated End-Stage
Renal Disease (ESRD) expenditures to be $292,117 over 10 years per
beneficiary on dialysis. Living donor kidney transplants (LDKT) was
cost-saving at 10 years, reducing expected medical expenditures for
ESRD treatment by 13 percent ($259,119) compared to maintenance
dialysis.
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\22\ Axelrod DA, Schnitzler MA, Xiao H, et al. An economic
assessment of contemporary kidney transplant practice. Am J
Transplant. 2018;18:1168-1176. https://doi.org/10.1111/ajt.14702.
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The approximately $33,000 in Medicare savings per beneficiary over
10 years for LDKT compared to maintenance dialysis is likely a lower
bound, since living donation would help reduce the number of
beneficiaries under the age of 65 who would be eligible for Medicare
enrollment. The lower bound conditional savings can be adjusted to
account for additional savings through reduced Medicare enrollment by
considering the share of potential new live donations across three main
scenarios.
The LDKT expected cost of $259,119 over 10 years per beneficiary
projected by Axelrod et al. (2018) assumes Medicare primary payer
status. For roughly 25 percent of LDKTs, Medicare is assumed as the
primary payer regardless of transplant success; therefore, the
projected spending need not be adjusted. For the next 25 percent of
LDKTs, the assumption was that the beneficiary is on dialysis and
Medicare is the primary payer, but they would eventually no longer need
dialysis and/or leave Medicare enrollment if they had a transplant, and
are not otherwise eligible for Medicare due to age or disability.
Therefore, the expected Medicare spending for these cases was adjusted
downward by 33 percent. This projected a savings of approximately
$119,000 over 10 years relative to the baseline spending projection of
$292,117 over 10 years for beneficiaries on dialysis. For the remaining
50 percent of LDKTs--it was assumed that Medicare is not the primary
payer when the transplant occurs. In this case, it was assumed that
Medicare spending is nominal relative to baseline spending of $292,117
over 10 years for beneficiaries on dialysis, and amounts were adjusted
downward by 33 percent (that is, for these beneficiaries, Medicare
would have become the primary payer 30 months to become a Medicare
primary payer enrollee absent the transplant), which projected a
savings of approximately $195,000 over 10 years. The projected weighted
average federal budgetary savings to the Medicare program for LDKT is
$136,000 over 10 years per beneficiary.
Therefore, a hypothetical 20 percent increase in the rate of LDKT
in model markets in a single year, representing about 500 new kidney
transplants mainly from relatives of recipients, would produce
approximately $68 million in federal budgetary savings to the Medicare
program over 10 years (and multiples thereof for each successive year
if the living donor kidney transplant rate was thusly elevated).
Overall, having more end stage renal disease (ESRD) individuals
receiving transplants will ultimately decrease Medicare
expenditures.\23\
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\23\ Obtained from proposed rule CMS-5527-P Specialty Care
Models to Improve Quality of Care and Reduce Expenditures posted on
July 18, 2019, and information available at https://www.federalregister.gov/documents/2019/07/18/2019-14902/medicare-program-specialty-care-models-to-improve-quality-of-care-and-reduce-expenditures.
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A. Initial Regulatory Flexibility Analysis
The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) and the
Small Business Regulatory Enforcement and Fairness Act of 1996, which
amended the RFA, require HHS to analyze options for regulatory relief
of small businesses. If a rule has a significant economic effect on a
substantial number of small entities, the Secretary must specifically
consider the economic effect of the rule on small entities and
[[Page 70145]]
analyze regulatory options that could lessen the impact of the rule.
HHS will use an RFA threshold of at least a 3 percent impact on at
least 5 percent of small entities. HHS has determined, and the
Secretary certifies, that this proposed rule will not have a
significant impact on the operations of a substantial number of small
manufacturers; therefore, we are not preparing an analysis of impact
for the purposes of the RFA.
B. Unfunded Mandates Reform Act
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any federal mandate 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.'' In 2019, that threshold is $154 million.
HHS does not expect this proposed rule to exceed the threshold.
C. Executive Order 13132--Federalism
HHS has reviewed this proposed rule in accordance with E.O. 13132
regarding federalism and has determined that it does not have
``federalism implications.'' This proposed rule would not ``have
substantial direct effects on the States, or on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.''
D. Collection of Information
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) (PRA)
requires that OMB approve all collections of information by a federal
agency from the public before they can be implemented. This proposed
rule is projected to have no impact on current reporting and
recordkeeping burden, as the amendments proposed in this rule will not
impose any data collection requirements under the PRA.
List of Subjects in 42 CFR Part 121
Health care, Hospitals, Transplant Centers, Organ Transplantation
Reporting and recordkeeping requirements.
Accordingly, by the authority vested in me as the Secretary of
Health and Human Services, and for the reasons set forth in the
preamble, 42 Code of Federal Regulations Part 121 is proposed to be
amended as follows:
PART 121--ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK
0
1. The authority citation for part 121 is amended to read as follows:
Authority: Sections 215, 371-77, and 377E of the PHS Act (42
U.S.C. 216, 273-274d, 274f-5); sections 1102, 1106, 1138 and 1871 of
the Social Security Act (42 U.S.C. 1302, 1306, 1320b-8, and 1395hh);
section 301 of the National Organ Transplant Act, as amended (42
U.S.C. 274e); and E.O. 13879, 84 FR 33817.
0
2. Revise Sec. 121.1 to read as follows:
Sec. 121.1 Applicability.
(a) The provisions of this part, with the exception of Sec. Sec.
121.13 and 121.14, apply to the operation of the Organ Procurement and
Transplantation Network (OPTN) and to the Scientific Registry.
(b) The provisions of Sec. 121.13 apply to the prohibition set
forth in section 301 of the National Organ Transplant Act, as amended.
(c) The provisions of Sec. 121.14 apply to the reimbursement of
specified incidental non-medical expenses incurred toward living organ
donation under section 377 of the Public Health Service Act, as
amended.
(d) In accordance with section 1138 of the Social Security Act,
hospitals in which organ transplants are performed and which
participate in the programs under titles XVIII or XIX of the Social
Security Act, and organ procurement organizations designated under
section 1138(b) of the Social Security Act, are subject to the
requirements of this part.
0
3. Add Sec. 121.14 to read as follows:
Sec. 121.14 Reimbursement for Living Organ Donors: Incidental Non-
Medical Expenses.
(a) The following incidental non-medical expenses incurred by
donating individuals toward making living donations of their organs may
be reimbursed:
(1) Lost wages;
(2) Child-care expenses; and
(3) Elder-care expenses.
(b) [Reserved]
Dated: December 16, 2019.
Thomas J. Engels,
Administrator, Health Resources and Services Administration.
Approved: December 16, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-27532 Filed 12-17-19; 4:15 pm]
BILLING CODE 4165-15-P