[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