To Research, Evaluate, Assess, and Treat (TREAT) Astronauts, 15352-15359 [2020-04784]

Agencies

• National Aeronautics and Space Administration

[Federal Register Volume 85, Number 53 (Wednesday, March 18, 2020)]
[Rules and Regulations]
[Pages 15352-15359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04784]


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NATIONAL AERONAUTICS AND SPACE ADMINISTRATION

14 CFR Part 1241

[Document Number NASA-20-028: Docket Number--NASA-2020-0001]
RIN 2700-AE51


To Research, Evaluate, Assess, and Treat (TREAT) Astronauts

AGENCY: National Aeronautics and Space Administration (NASA).

ACTION: Interim final rule; request for comments.

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SUMMARY: With this interim final rule, the National Aeronautics and 
Space Administration (NASA) is amending its regulations to add a new 
part that will implement the provisions of the TREAT Astronauts Act. 
The new regulations will provide for the medical monitoring and 
diagnosis of conditions that are potentially spaceflight-associated and 
treatment of conditions that are spaceflight-associated for former U.S. 
Government astronauts and payload specialists.

DATES: 
    Effective: March 18, 2020.
    Comments due: Send comments on or before May 18, 2020.

ADDRESSES: You may send comments, identified by docket number NASA-
2019-0004 and/or RIN number 2700-AE51, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for sending comments.
     Email: [email protected]. Include docket 
number NASA-2019-0004 and/or RIN number 2700-AE51 in the subject line 
of the message.
     Mail: NASA Headquarters, Mail Code 2M21, ATTN: Gwyn E. 
Smith, 300 E St. SW, Washington, DC 20546-0001.
    Instructions: All submissions received must include the agency name 
and docket number or Regulatory Information Number (RIN) for this 
rulemaking. All comments received will be posted without change to 
https://www.regulations.gov, including any personal information 
provided.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Gwyn E. Smith, Policy Manager, Office 
of the Chief Health and Medical Officer, 1-833-996-1685, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    NASA currently has a voluntary medical monitoring program, Lifetime 
Surveillance of Astronaut Health (LSAH) program, for all U.S. 
Government astronauts and payload specialists at the NASA Johnson Space 
Center (JSC). Once they leave the astronaut corps, former U.S. 
Government astronauts and payload specialists rely on workers' 
compensation and other U.S. Government programs to provide diagnosis 
and treatment for spaceflight-associated conditions. There is no formal 
mechanism for NASA to receive diagnosis and treatment data on such 
conditions.
    As of November 2019, there are approximately 250 living former U.S. 
Government astronauts and payload specialists. The Agency currently 
affords occupationally related medical monitoring services through the 
LSAH program to former U.S. Government astronauts and payload 
specialists at the JSC with a 60-70 percent participation rate.
    On March 21, 2017, the President signed into law the National 
Aeronautics and Space Administration Transition Authorization Act of 
2017, Public Law 115-10 (2017). Title IV, Subtitle D, the ``To 
Research, Evaluate, Assess, and Treat Astronauts Act'' (hereafter 
``TREAT Astronauts Act'' or ``Act'') is codified at Section 20149 of 
Title 51 of the U.S. Code.
    The TREAT Astronauts Act provides NASA the authority to expand the 
voluntary monitoring program by developing a more comprehensive 
occupational surveillance program that will enable earlier detection 
and diagnosis of medical conditions ``potentially associated'' with 
spaceflight and treatment of medical conditions associated with 
spaceflight. NASA currently uses data from the LSAH program to tailor 
clinical care for individual astronauts, as well as to inform the human 
systems risks, current spaceflight operations, and future vehicle 
standards. The comprehensive occupational surveillance program will 
provide NASA with more comprehensive data that will ultimately 
contribute to an improved understanding of the long-term impact of 
spaceflight. This enhanced program is expected to increase the former 
U.S. Government astronaut and payload specialist participation rate in 
the occupational surveillance program to over 80 percent.
    Human spaceflight poses significant challenges and is full of 
substantial risk. NASA and its astronauts acknowledge and accept the 
risks of spaceflight are beyond those of ordinary daily living. 
Participation in long duration missions or multiple shorter duration 
missions, increases health risks such as, vision impairment, bone 
demineralization, and behavioral health issues. In addition, exposure 
to high levels of radiation and microgravity can result in acute and 
long-term health consequences that can increase the risk of cancer and 
tissue degeneration and have potential effects on the musculoskeletal 
system, central nervous system, cardiovascular system, immune function, 
and vision.
    NASA has also seen an increase in health issues former U.S. 
Government astronauts and payload specialists face, many years after 
their NASA service. One of the vital tools NASA needs to prepare for 
future long-duration and exploration missions is more data on the 
health effects humans face in

[[Page 15353]]

spaceflight. Data collected under the TREAT Astronauts Act will allow 
NASA to examine health trends in astronauts over the course of their 
lifetime to understand better the physical, behavioral, 
microbiological, and molecular reaction of the human body. These data 
will also contribute to the overall knowledge of the Agency and serve 
to identify spaceflight risks to human health and develop mitigation 
strategies as NASA moves ahead to long-duration and exploration 
missions. Given the fact that there are so few astronauts and such 
limited data, increased participation to get more data is critical. 
NASA is learning daily of the untoward effects of human spaceflight on 
the human body. In order to prepare for the Moon in 2024, NASA needs to 
understand these effects so appropriate mitigation measures can be 
taken now.
    This program will inform future generations by providing health 
data showing the effects of spaceflight activities on active and former 
U.S. Government astronauts and payload specialists and thereby ensuring 
that their legacy and NASA's mission continues. This data will become 
increasingly valuable to improving our understanding of many diseases 
humans face on Earth.

II. Section-by-Section Analysis

Section 1241.10 Covered Medical Care

    This section establishes key tenets of the program as defined in 
the TREAT Astronauts Act unless specifically stated otherwise. NASA 
will provide monitoring and diagnosis for conditions potentially 
associated with spaceflight and treatment for conditions associated 
with spaceflight. For clarity and ease of reading, we are using 
``spaceflight-associated condition'' as defined in 14 CFR 1241.15 
versus ``condition associated with spaceflight'' as used in the TREAT 
Astronauts Act. Monitoring, diagnosis, and treatment will be provided 
by a local health care provider if it is unadvisable for the former 
U.S. Government astronaut or payload specialist to travel to the JSC. A 
provision has been added to also allow for monitoring, diagnosis, and 
treatment at a local health care provider if it is advantageous to the 
Government. For example, if additional tests are needed after the 
individual has returned home from JSC, they could be done locally if it 
is more cost effective. NASA will provide medical monitoring, 
diagnosis, and treatment without a cost sharing obligation imposed on 
the former U.S. Government astronaut or payload specialist. This means 
NASA will pay, as a secondary payer, for any medical costs associated 
with the monitoring and diagnosis of a condition that is potentially 
associated with spaceflight and will pay, as the secondary payer, for 
any medical costs associated with the treatment of a condition that is 
associated with spaceflight. This includes deductibles, coinsurance, 
copayments, and similar charges, but excludes insurance premiums. 
Lastly, the law limits NASA's authority to pay for medical treatment to 
the role of secondary payer. The type of primary coverage available to 
former U.S. Government astronauts and payload specialists will depend 
on their status at the time of their active astronaut career and any 
current health plan, Federal benefits program, or other workers' 
compensation coverage that may apply. For former U.S. Government 
astronauts and payload specialists who believe they have a condition 
related to their spaceflight, they must first seek treatment from the 
Department of Defense Military Health System, the Department of Labor 
Office of Workers' Compensation Programs Division of Federal Employees' 
Compensation, or through their private health insurance, where 
applicable. The JSC Flight Medicine Clinic will assist the former U.S. 
Government astronauts and payload specialists with these processes as 
well as filing a claim with NASA.

Section 1241.15 Definitions

    This section defines terms used in the TREAT Astronauts Act and 
this rule. We define:

--``Conditional payments'' as described in the TREAT Astronauts Act. 
This helps ensure the U.S. Government astronauts and payload 
specialists get prompt monitoring, diagnosis, and treatment for 
potential spaceflight-associated conditions, prior to primary payer 
formal claim submission and adjudication, as appropriate.
--``Cost sharing'' as described in the TREAT Astronauts Act prescribes 
that former U.S. Government astronauts and payload specialists 
participating in the program will receive monitoring, diagnosis, and 
treatment without cost sharing obligation. This means that medical 
monitoring, diagnosis, or treatment authorized under this Act shall be 
provided without any deductible, copayment, or other cost sharing 
obligation.
--``Monitoring, diagnosis, and treatment'' as consistent with current 
use in the medical community. Diagnosis and treatment are provided, 
consistent with the accepted standard of care. However, due to the 
unique nature of spaceflight, monitoring is based on a NASA astronaut 
spaceflight exposure clinical assessment. For example, as part of 
routine monitoring, NASA provides bone density scanning for young 
healthy males. This testing is beyond the accepted standard of care.
--``Eligible individual'' to include both former U.S. Government 
astronauts and former payload specialists who have flown in space, 
while specifically excluding others who are not included in these 
groups. U.S. Government astronaut is defined in the TREAT Astronauts 
Act as the meaning given the term ``Government astronaut'' in 51 U.S.C. 
50902, except it does not include an individual who is an international 
partner astronaut. The term ``Government astronaut'' is defined in 51 
U.S.C. 50902.

    For clarification, the following are specifically excluded:
    (1) Astronauts of other United States Government agencies--only 
astronauts who participate in NASA programs are eligible under the 
TREAT Astronauts Act, so if Department of Defense or Department of 
Labor, for example, had astronauts, they would not be covered under the 
TREAT Astronauts Act;
    (2) Employees of commercial spaceflight companies who were never 
employed by NASA nor a member of the Uniformed Services assigned to 
NASA--commercial spaceflight astronauts, i.e., astronauts who flew for 
commercial spaceflight companies, even if they participated in a 
mission to a NASA vehicle, say the International Space Station, are not 
eligible under the TREAT Astronauts Act;
    (3) International partner astronauts--a term used specifically for 
NASA's partners in the International Space Station, excluding Russia, 
are specifically excluded in the TREAT Astronauts Act;
    (4) Employees of foreign governments--astronauts who have flown to 
space with NASA but are not U.S. Government astronauts are not 
eligible; and
    (5) Private individuals or tourists who have flown in space--
private individuals and tourists who have flown to space with NASA, but 
are not U.S. Government astronauts are not eligible; and
    (6) Former astronauts, including members of the Uniformed Services, 
and former payload specialists who have not flown in space--The 
definition of U.S. Government astronauts includes only those 
individuals who have flown into space, and therefore, those who have 
not flown to space are not eligible under the TREAT Astronauts Act.

[[Page 15354]]

    We use the term ``eligible individual'' in this rule instead of the 
compound term ``former U.S. Government astronaut and former payload 
specialists'' as used in the TREAT Astronauts Act to clarify 
specifically who may participate in this program.

--``Program'' to mean the medical monitoring, diagnosis, and treatment 
authorized by the TREAT Astronauts Act to enhance the readability of 
the rule.
--``Primary Payer'' as it is commonly used within the medical 
community. Primary payer means the entity that pays first, up to the 
limits of its coverage.
--``Secondary Payer'' to mean the entity that pays after all primary 
payers have paid, up to the limits of their coverage. This means NASA 
will pay, in toto, as the secondary payer for any monitoring and 
diagnosis for potentially spaceflight-associated conditions and for any 
treatment for spaceflight-associated conditions. This includes any out-
of-pocket cost-sharing expenses not covered by the primary payers.
--``Spaceflight-Associated Condition'' to mean the same as the TREAT 
Astronauts Act ``condition associated with spaceflight.'' This change 
in terminology enhances readability of the rule.
--``TREAT Astronauts Act Board (TAAB)'' as the internal NASA board that 
makes recommendations to the NASA Administrator or designee. The 
internal NASA charter for this board will detail the functions, 
membership, and operations. The decision-making process is detailed in 
14 CFR 1241.6.

Section 1241.20 Eligibility

    This section addresses eligibility of the former U.S. Government 
astronauts and payload specialists. There are currently approximately 
250 former U.S. Government astronauts and payload specialists who may 
participate in this program. Eligible individuals must also meet other 
requirements defined herein to receive monitoring, diagnosis, and 
treatment under this program. Participation is strictly voluntary, that 
is, NASA cannot require former U.S. Government astronaut and payload 
specialists to participate.

Section 1241.25 Basic Program

    This section describes the basic components of the program offered 
to former U.S. Government astronauts and payload specialists. In 
addition to providing monitoring, diagnosis, and treatment, NASA, as 
part of the no cost sharing obligation, will also cover travel expenses 
incurred. NASA currently covers travel expenses for its occupational 
surveillance program and will extend this no cost sharing across the 
program. Monitoring of potentially spaceflight-associated conditions is 
nominally provided at the JSC Flight Medicine Clinic. When necessary, 
due to the health of the former U.S. Government astronaut or payload 
specialist, monitoring may be provided locally, so as not to burden the 
eligible individual with travel. In addition, NASA may also opt to use 
a provider local to the eligible individual, if it is otherwise 
advantageous to the Government. This allows NASA to reduce costs as 
much as possible. Diagnosis and treatment is handled on a case-by-case 
basis, with the location of the provider dependent on the medical 
appropriateness of the facility, patient, preferences, cost 
effectiveness, and other pertinent factors. Each case is different and 
this allows NASA to provide the best possible care for each eligible 
individual. Eligible individuals who agree to participate in this 
program must agree that NASA is entitled to copies of any medical 
records associated with the monitoring, diagnosis, and treatment. They 
must further agree to submit all paperwork necessary for NASA to obtain 
copies of these records. And finally, they must agree that NASA may use 
and disclose this data within the limits of the law.
    NASA will provide monitoring and diagnosis of eligible individuals 
for conditions potentially associated with spaceflight and treatment 
for spaceflight-associated conditions. NASA provides a lifetime 
occupation surveillance program, which includes a standard set of 
monitoring offered yearly to former U.S. Government astronauts and 
payload specialists. In addition to this yearly offering, additional 
monitoring is provided, as necessary, based on each eligible 
individual's medical needs. A provision has been added specifically for 
NASA to also request autopsies, as part of monitoring, be performed as 
they may contribute substantially to the knowledge of spaceflight 
physiology or pathology.
    As mentioned previously, NASA is not authorized to provide 
monitoring and diagnosis for conditions not potentially associated with 
spaceflight or treatment for conditions not spaceflight-associated. 
Should a condition be diagnosed that is not related to spaceflight, the 
individual will be referred to their primary care physician.

Section 1241.30 Program Participation and Claims Submission

    This section details the steps an eligible individual must take, 
with assistance from the JSC Flight Medicine Clinic, to participate in 
this program. Former U.S. Government astronauts and payload specialists 
already receive an annual invitation from NASA to participate in NASA's 
occupational surveillance program. No claim is required to participate 
in NASA's occupational surveillance program. This current program has a 
60-70 percent participation rate. Eligible individuals must first seek 
primary coverage before submitting a claim to NASA, as NASA is a 
secondary payer. The type of primary coverage available to former U.S. 
Government astronauts and payload specialists will depend on their 
status at the time of their active astronaut career and any current 
health plan, Federal benefits program, or other workers' compensation 
coverage that may apply. For former U.S. Government astronauts and 
payload specialists who believe they have a condition related to their 
spaceflight, they must first seek treatment from the Department of 
Defense Military Health System, the Department of Labor Office of 
Workers' Compensation Programs Division of Federal Employees' 
Compensation, or through their private health insurance, where 
applicable. If the eligible individual is enrolled, or eligible to be 
enrolled in the U.S. Department of Veterans Affairs (VA) health care 
system and chooses to obtain care and services through VA, the 
individual will receive health care benefits in accordance with chapter 
17 of title 38, United States Code, as implemented by the Secretary of 
Veterans Affairs. Moreover, as to the costs of VA care and services, 
there will be no ``coordination of benefits,'' as this term is 
generally understood in the health care industry, between VA and NASA. 
That is, VA would pay the full cost of the care. Under the TREAT 
Astronauts program, the eligible individual may seek reimbursement from 
NASA for any out-of-pocket copayment(s) he or she paid to VA for care 
of a condition that NASA determines is associated with spaceflight; and 
finally, VA has no special treatment authority (or copayment exemption) 
for former U.S. Government astronauts and payload specialists seeking 
treatment for conditions associated with spaceflight. As to 
compensation for disability related to service in the Armed Forces, an 
eligible individual who has Veteran status is free to file a claim for 
disability compensation with the Veterans

[[Page 15355]]

Benefits Administration, pursuant to 38 CFR part 3. The JSC Flight 
Medicine Clinic will assist the former U.S. Government astronauts and 
payload specialists with these processes as well as filing a claim with 
NASA.
    This section also details the specific information required to 
submit a claim to NASA and identifies a website where additional 
information is available. The NASA Flight Medical Clinic will assist 
eligible individuals with claims submission, but is not authorized to 
prepare the claim on behalf of the eligible individual.

Section 1241.35 Claims Review and Decision

    This section explains the review and decision-making process for 
claims submitted to NASA by eligible individuals. The TREAT Astronauts 
Act Board (TAAB) is an internal NASA board of physicians who will 
review claims submitted to NASA. The TAAB will consider all 
information, including information about other exposures, provided for 
a case and consult with other experts and specialists as appropriate. 
The TAAB will provide a recommendation to the Administrator or designee 
who will make the final decision on approval or denial of the claim. 
The eligible individual will be notified of the decision promptly and, 
should the claim be denied, be afforded the opportunity to submit 
additional information for reconsideration of the claim. There is no 
limit to the number of times an eligible individual can submit new 
information through a reconsideration request.

Section 1241.40 Payment of Approved Claims

    This section details the payment process for approved claims. NASA 
payments are applied secondarily to other U.S. Government entities or 
primary payers and may include the remaining out-of-pocket costs from 
primary payer coverage. Travel expenses are paid consistent with the 
Federal Travel Regulations and may include expenses for an assistant 
should the eligible individual need travel assistance. Conditional 
payments are also allowed to ensure the eligible individual gets the 
care needed promptly. NASA may attempt to recover these costs from the 
primary payer or the eligible individual if the claim is subsequently 
denied.

Section 1241.45 Collaboration With Other Agencies

    This section simply states that NASA will collaborate with other 
agencies as necessary to acquire medical records as allowable by law. 
As a condition of participating in the program, eligible individuals 
will have consented to allowing NASA to collect this information.

Section 1241.50 Records, Confidentially, Privacy and Data Use

    This section states that NASA will adhere to all required privacy 
regulations and policies and will enter into data sharing agreements 
with other agencies as necessary to obtain required data.

III. Effect of Rulemaking

    Title 14 of the Code of Federal Regulations, as revised by this 
interim final rulemaking, represents NASA's implementation of its legal 
authority on this subject. Other than future amendments to this 
regulation or governing statutes, no contrary guidance or procedures 
are authorized. All existing or subsequent NASA guidance must be read 
to conform with this rulemaking, if possible, or if not possible, such 
guidance is superseded by this rulemaking.

IV. Regulatory Analysis Section

Administrative Procedure Act (APA)

    The Administrative Procedure Act requires notice of any proposed 
rule to be published in the Federal Register ``unless persons subject 
thereto are named and either personally served or otherwise have actual 
notice thereof in accordance with the law,'' 5 U.S.C. 553(b). NASA has 
determined that through its extensive outreach efforts that actual 
notice has been provided to all interested parties--250 former 
astronauts and payload specialists, including several current Federal 
employees, and that this rule has no effect on the public beyond the 
250 former astronauts. In drafting these regulations, NASA officials 
met with former U.S. Government astronauts and payload specialists, 
communicating and soliciting input from as many individuals as 
possible, through a variety of venues, including communications from 
the former NASA Administrator, professional meetings, the Potomac 
Institute for Policy Studies, the annual astronaut reunion, 
newsletters, online via the Life Sciences Data Archive and NASA TREAT 
Astronauts Act websites, as well as personal communications with former 
astronauts on how best to implement the program. These mechanisms have 
allowed us to notify the small group of interested individuals and 
enabled them opportunities to provide NASA with input regarding the 
development of this program. While an internet posting and a single 
meeting has been found insufficient to replace publication in the 
Federal Register, see Utility Solid Waste Activities Grp. v. EPA, 236 
F.3d 749, 754 (D.C. Cir. 2001), NASA's efforts to provide actual notice 
was much more expansive and successful. See Common Carrier Conference-
Irregular Route v. United States, 534 F.2d 981, 982 (D.C. Cir. 1976) 
(finding notice adequate because the affected parties were ``generally 
on notice'' through conduct of agency). Based on the forgoing, the 
agency has concluded that the individuals affected by this regulation 
have received actual notice and that publication in the Federal 
Register is not necessary. Nevertheless, for the avoidance of potential 
controversy and because of potential public interest, NASA has decided 
to publish these regulations as an interim final rule in the Federal 
Register.
    In accordance with 5 U.S.C. 553, the Administrator of NASA has also 
concluded that there is good cause to publish this rule without prior 
opportunity for public comment. Good cause may be shown when the Agency 
finds that ``notice and public procedure thereon are impracticable, 
unnecessary, or contrary to the public interest.'' See 5 U.S.C. 
553(b)(B). Furthermore, in accordance with 5 U.S.C. 553, the 
Administrator of NASA has concluded there is good cause to publish this 
rule with an immediate effective date. An agency may dispense with the 
required 30 day effective date if ``as otherwise provided by the agency 
for good cause found and published with the rule.'' See 5 U.S.C. 
553(d)(3).
    As explained above, on March 21, 2017, the President signed into 
law the NASA Transition Act of 2017. The TREAT Astronauts Act, which is 
part of the NASA Transition Act of 2017, gives NASA the authority to 
provide former U.S. Government astronauts and payload specialists 
medical monitoring and diagnosis for conditions that are potentially 
spaceflight associated and treatment for conditions that are 
spaceflight associated.
    As directed by Congress in section 443 of Public Law 115-10, NASA 
first entered into an arrangement with an independent external 
organization to undertake an independent estimate of the cost to the 
Administration and the Federal Government to implement and administer 
activities under the TREAT Astronauts Act. This cost estimate was 
submitted to both the House Science, Space and Technology Committee and 
the Senate Commerce, Science and Transportation Committee on March 14, 
2018. NASA also, as directed by

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Congress, carried out a study on any potential privacy or legal issues 
related to the possible sharing beyond the Federal Government of data 
acquired under the TREAT Astronauts Act. This was submitted to both the 
House Science, Space and Technology Committee and the Senate Commerce, 
Science and Transportation Committee on January 2, 2018. With the 
completion of these reports, NASA then began drafting these 
regulations.
    In drafting these regulations, NASA officials met with former U.S. 
Government astronauts and payload specialists, as discussed more fully 
above. NASA also met with officials from the Department of Labor, 
Department of Veterans' Affairs, and the Defense Health Agency, 
critical partner agencies, who have an important stake in the outcome, 
on how best to collaborate and how to implement any required data 
sharing agreements.
    Good Cause. To establish a good cause exception to the APA 
requirement to publish a proposed rule, an Agency must show that notice 
would be either impracticable, unnecessary, or contrary to the public 
interest. See 5 U.S.C. 553(b)(B). An agency is further required to 
establish good cause for publishing a substantive rule less than 30 
days before its effective date. See 5 U.S.C. 553(d)(3). NASA believes 
that publication of a proposed rule is unnecessary and that there is 
good cause for the effective date of this rule to be less than 30 days 
after the date of publication.
    Human space exploration poses significant challenges and is full of 
risk. With more recent long-duration space flight missions, NASA has 
seen the increased health risks that current U.S. Government astronauts 
face, such as vision impairment, bone demineralization, and exposure to 
radiation. NASA has also seen the increased health risks that former 
U.S. Government astronauts and payload specialists face, many years 
after their NASA service. Consequently, it is critical that NASA move 
forward with this rule without delay to ensure claims that are 
associated with human spaceflight are fully covered.
    One of the vital tools NASA needs to prepare for future long-
duration and exploration missions is data on the health effects human 
face in spaceflight. NASA needs these data to better understand the 
physical, behavioral, microbiological, and reaction on the molecular 
level of the human body to an extended period of time in space. Former 
U.S. Government astronauts and payload specialists who voluntarily 
participate in this program will be consenting to providing their 
medical data to NASA. Given the fact that there are so few astronauts 
and such limited data, increased participation to get more data is 
critical. NASA is learning daily of the untoward effects of human 
spaceflight on the human body. In order to prepare for the Moon in 
2024, NASA needs to understand these effects so that we can take 
appropriate mitigation measures now.
    As discussed more fully above, it is critical for NASA to start 
treating former U.S. Government astronauts and payload specialists for 
medical conditions that we are now beginning to understand many years 
later may be the results of their prior space flight exposure. We have 
also learned more recently of the urgency of early diagnosis and 
treatment and that former astronauts may present symptoms differently 
than the general population. Due to the small population of astronauts, 
it is imperative that we increase our collection of data immediately so 
that we can utilize it to mitigate the risks of spaceflight to future 
and current astronauts and take care of those former astronauts with 
conditions associated with spaceflight. Since Astronaut Scott Kelly's 
2015-2016 record year in space, nineteen astronauts have participated 
in longer space duration flights of up to one year, and NASA's goal is 
to return to the Moon by 2024. By increasing the population of former 
astronauts who are being monitored, NASA will be able to better 
understand the effects of space flight and institute ameliorative 
measures.
    The unnecessary prong of the good cause inquiry is ``confined to 
those situations in which the administrative rule is a routine 
determination, insignificant in nature and impact, and inconsequential 
to the industry and the public. See Mack Trucks, Inc., v. EPA, 682 F.3d 
87, 94 (D.C. Cir. 2012). This new rule applies only to a very limited 
and easily discernable group of beneficiaries--approximately 250 former 
U.S. Government astronauts and payload specialists. It does not affect 
any other member of the public in any significant way and, therefore, 
advanced notice is unnecessary.\1\
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    \1\ As discussed above, the Agency believes that actual notice 
has been provided to former astronauts rendering the publication 
requirement of the APA unnecessary.
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    The Agency has also established good cause for dispensing with the 
30-day delay in the effective date in accordance with 5 U.S.C. 
553(d)(3). Unlike the notice and comment requirements, which are 
designed to ensure public participation in rulemaking, the 30-day 
waiting period is intended to give affected parties time to adjust 
their behavior before the final rule takes effect. Given the limited 
number of parties affected by the new rule, the facts that 
participation is voluntary and those impacted would like to be treated 
immediately, the urgency of the matter, and the discussion above, good 
cause has been shown.
    For these reasons, the Agency will publish this rule without prior 
opportunity for public comment and with an immediate effective date. 
Thus, the Administrator issues this rule as an interim final rule with 
request for comments.

Executive Order 12866--Regulatory Planning and Review and Executive 
Order 13563--Improving Regulation and Regulatory Review

    Executive Orders (E.O.) 12866 and 13563 direct agencies to assess 
all costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). E.O. 
13563 emphasizes the importance of quantifying both costs and benefits, 
reducing costs, harmonizing rules, and promoting flexibility. This rule 
is a significant regulatory action and has been reviewed by the Office 
of Management and Budget in accordance with E.O. 12866.

Executive Order 13771--Reducing Regulations and Controlling Regulatory 
Costs

    This rule is not expected to be an E.O. 13771 regulatory action 
because this rule is expected to be related to agency organization, 
management, or personnel.

Regulatory Flexibility Act

    It has been certified that this rule is not subject to the 
Regulatory Flexibility Act (5 U.S.C. 601) because it would not have a 
significant economic impact on a substantial number of small entities.

Paperwork Reduction Act

    This rule contains information collection requirement subject to 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These 
requirements are found under Office of Management and Budget control 
number 2700-0171, NASA TREAT Astronauts Act.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by state, local, and 
tribal governments, in the aggregate, or by the

[[Page 15357]]

private sector, of $100,000,000 or more in any one year, and it will 
not significantly or uniquely affect small governments.

List of Subjects in 14 CFR Part 1241

    Health, Medical, Astronaut.


0
For reasons set forth in the preamble, NASA adds part 1241 to 14 CFR 
chapter V to read as follows:

PART 1241--TO RESEARCH, EVALUATE, ASSESS, AND TREAT (TREAT) 
ASTRONAUTS

Sec.
1241.05 Purpose and scope
1241.10 Covered medical care
1241.15 Definitions
1241.20 Eligibility
1241.25 Basic program
1241.30 Program participation and claims submission
1241.35 Claims review and decisions
1241.40 Payment of approved claims
1241.45 Collaboration with other agencies
1241.50 Records, confidentially, privacy, and data use

    Authority: 51 U.S.C. 20149.


Sec.  1241.05  Purpose and scope.

    (a) This part establishes a program and sets out the eligibility 
requirements and procedures to effectuate section 443 of the ``To 
Research, Evaluate, Assess, and Treat Astronauts Act of 2017.''
    (b) The purpose of this program is to provide medical monitoring 
and diagnosis of former U.S. Government astronauts and payload 
specialists for conditions the Administrator considers potentially 
associated with spaceflight and to provide treatment of former U.S. 
Government astronauts and payload specialists for conditions the 
Administrator considers associated with spaceflight.


Sec.  1241.10  Covered medical care.

    (a) Subject to the limitations in paragraph (b) of this section, an 
eligible individual, as defined in Sec.  1241.15, is eligible for:
    (1) Monitoring and diagnosis for potentially spaceflight-associated 
conditions; and
    (2) Treatment for spaceflight-associated conditions.
    (b) Medical monitoring, diagnosis, and treatment authorized and 
described in paragraph (a) of this section will not be provided for any 
condition that is found by the NASA Administrator or designee to have 
resulted from a cause other than the eligible individual's 
participation in spaceflight-related activities. Should a condition be 
diagnosed that is not related to spaceflight, the individual will be 
referred to their primary care physician.
    (c) Medical monitoring, diagnosis, and treatment authorized and 
described in paragraph (a) of this section may be provided by a local 
health care provider if the NASA Administrator or designee determines 
it is unadvisable for the eligible individual to travel to the NASA 
Johnson Space Center (JSC) due to the individual's condition or if it 
is otherwise advantageous to the Government.
    (d) Medical monitoring, diagnosis, and treatment authorized and 
described in paragraph (a) of this section will be provided without a 
cost sharing obligation imposed on the eligible individual.
    (e) NASA is a secondary payer.


Sec.  1241.15  Definitions.

    Conditional Payment means a NASA payment to a medical provider or 
eligible individual to pay for the cost of medical monitoring, 
diagnosis, and treatment. Such conditional payments may be made prior 
to a formal determination that a psychological or medical condition is 
spaceflight-associated if payment has not been made or cannot 
reasonably be expected to be made promptly by the primary payer.
    Cost Sharing means a multiparty arrangement under which costs of a 
program are shared by the involved parties, according to an agreed upon 
formula. For this program, there is no cost sharing obligation by the 
eligible individual. The eligible individual is responsible for 
insurance premiums.
    Diagnosis means the identification of a medical or psychological 
condition consistent with the exercise of professional clinical 
judgment and accepted standard of care by licensed health 
professionals.
    Eligible Individual means a former United States Government 
astronaut, including a member of the Uniformed Services, or a former 
payload specialist who has flown in space, as defined in the TREAT 
Astronauts Act. The following individuals are specifically excluded 
from eligible individuals:
    (1) Astronauts of other United States Government agencies;
    (2) Employees of commercial spaceflight companies who were never 
employed by NASA nor a member of the Uniformed Services assigned to 
NASA;
    (3) International partner astronauts;
    (4) Employees of foreign governments;
    (5) Private individuals or tourists who have flown in space; and
    (6) Former astronauts, including members of the Uniformed Services, 
and former payload specialists who have not flown in space.
    JSC means Johnson Space Center.
    Monitoring means the NASA astronaut spaceflight exposure clinical 
assessment of medical and psychological health status by licensed 
health professionals.
    Payload Specialist means an individual other than a NASA astronaut 
(commander, pilot, and mission specialist) whose presence was required 
onboard the space shuttle vehicle to perform specialized functions with 
respect to operation of one or more payloads or other essential mission 
activities.
    Primary Payer means the entity, U.S. Government agency or private 
health insurer, which is responsible to make payment to the eligible 
individual first, up to the limits of its coverage or authority.
    Program means the medical monitoring, diagnosis, and treatment 
authorized by the TREAT Astronauts Act.
    Secondary Payer means the entity that pays after all primary payers 
have paid, up to the limits of their coverage. Secondary payments, as 
described in the TREAT Astronauts Act, are payments or reimbursement 
for the medical monitoring, diagnosis, or treatment secondary to any 
obligation of the U.S. Government or any third party under any other 
provision of law or contractual agreement to pay for or provide such 
medical monitoring, diagnosis, or treatment.
    Spaceflight-Associated Condition means a medical or psychological 
condition that the NASA Administrator or designee designated by the 
NASA Administrator determines is at least as likely as not to have 
resulted from participation in spaceflight-related activities.
    Treatment means the accepted standard of clinical care for a 
medical or psychological condition by licensed health professionals.
    TREAT Astronauts Act means section 443 of the ``To Research, 
Evaluate, Assess, and Treat Astronauts Act of 2017.''
    TREAT Astronauts Act Board or TAAB means the internal NASA review 
board that provides recommendations to the NASA Administrator or 
designee as to whether or not a medical claim initiated by an eligible 
individual meets the standards for spaceflight association for medical 
monitoring, diagnosis, and treatment under the TREAT Astronauts Act.
    U.S. Government Agency means ``agency'' as defined in 5 U.S.C. 551.


Sec.  1241.20  Eligibility.

    (a) This section sets forth those persons who, by the provisions of 
the

[[Page 15358]]

TREAT Astronauts Act, are eligible to participate in this program. A 
determination by the Administrator or designee that a person is 
eligible does not automatically entitle such a person to medical 
monitoring, diagnosis, and treatment under the TREAT Astronauts Act.
    (b) Only eligible individuals defined in Sec.  1241.15 are entitled 
to medical monitoring, diagnosis, and treatment under this part.
    (c) Participation in this program is strictly voluntary. NASA may 
not require an eligible individual to participate in this program.


Sec.  1241.25  Basic program.

    (a) General--(1) Scope. Subject to all applicable definitions, 
conditions, limitations, or exclusions specified in this part, NASA 
will provide medical monitoring and diagnosis of potentially 
spaceflight-associated conditions and treatment of a spaceflight-
associated conditions, as well as any associated travel expenses for 
the eligible individual's lifetime.
    (2) Location of medical monitoring, diagnosis, and treatment. (i) 
Medical monitoring will be provided for eligible individuals at the 
JSC.
    (ii) When travel is inadvisable due to the health of the eligible 
individual or when otherwise advantageous to the Government, monitoring 
may be provided at a location other than the JSC.
    (iii) Diagnosis and treatment will be provided for eligible 
individuals at locations determined by the medical appropriateness of 
the facility, patient preferences, cost effectiveness, and other 
pertinent factors.
    (3) Right to information. As a condition precedent to participation 
in this program, NASA is entitled to receive copies of medical records 
from any physician, hospital or other person, health insurance company, 
institution, or entity (including a local, state, or U.S. Government 
agency) providing medical monitoring, diagnosis, and treatment to the 
eligible individual for which claims or requests for approval for 
medical monitoring, diagnosis, and treatment are submitted to NASA. As 
part of this condition precedent, NASA may require eligible individuals 
to complete such medical releases needed to facilitate obtaining such 
information as legally required by state and Federal law.
    (b) Monitoring and Diagnosis. NASA will provide monitoring and 
diagnosis for eligible individuals for conditions potentially 
associated with spaceflight.
    (1) Standardized monitoring will be offered routinely at the JSC.
    (2) Individualized monitoring will be provided, as necessary.
    (3) NASA may pay for and obtain autopsies of eligible individuals, 
who previously consented in writing or with consent of the next of kin, 
when such autopsy would contribute substantially to the knowledge of 
spaceflight physiology or pathology. NASA will coordinate with the 
Armed Forces Medical Examiner System for such autopsies.
    (c) Treatment. NASA will provide or arrange for the treatment of 
spaceflight-associated conditions.
    (1) Treatment will be secondary to any services provided by primary 
payers.
    (2) Should urgency dictate, NASA may provide for conditional 
payments for treatment.
    (d) Exclusions and limitations. In addition to any definitions, 
requirements, conditions, or limitations enumerated and described in 
other sections of this part, the following are specifically excluded:
    (1) Medical monitoring or diagnosis of an eligible individual for 
any medical or psychological condition that is not potentially 
associated with human spaceflight; and
    (2) Treatment of an eligible individual for any medical or 
psychological condition that is not associated with human spaceflight.


Sec.  1241.30  Program participation and claims submission.

    (a) General program participation. An eligible individual, or their 
authorized representative, who seek to participate in this program must 
provide the information set forth in paragraph (e)(2) of this section 
to NASA. The JSC Flight Medicine Clinic will assist eligible 
individuals through these processes.
    (b) NASA's occupationally related medical monitoring services. (1) 
Eligible individuals will receive an annual invitation from NASA to 
participate in NASA's occupational surveillance program;
    (2) [Reserved]
    (c) Primary payer coverage of diagnosis and treatment services. (1) 
Former Civil Servants. Eligible individuals who were civil servant 
employees during their active astronaut or payload specialist career 
who believe they have sustained a spaceflight-associated condition and 
are seeking coverage for medical treatment under this part must submit 
a notice of injury and claim for compensation through their agency to 
the Department of Labor, Office of the Workers' Compensation Programs 
Division of Federal Employees' Compensation (DFEC) consistent with 5 
U.S.C. Chapter 81 and 20 CFR part 10 before making a claim under the 
TREAT Astronauts Act.
    (2) Members of the Uniformed Services. Eligible individuals who 
were members of the Uniformed Services during their active astronaut or 
payload specialist career, or who are otherwise determined to be 
eligible by their Uniformed Service and who believe they have sustained 
a spaceflight-associated condition must contact their Service to 
determine eligibility for health and dental care and/or coverage 
through the Military Health System of the Department of Defense, 
consistent with 10 U.S.C. Chapter 55 and 32 CFR part 199 before making 
a claim under the TREAT Astronauts Act.
    (3) Former Civil Servants who were also Members of the Uniformed 
Services. Eligible individuals whose active astronaut career spanned 
both military and civil service will first submit a notice to the 
Department of Labor who will work with the Department of Defense.
    (4) Eligible individuals with claims denied or partially covered. 
If the eligible individual's claim under paragraphs (c)(1), (2), or (3) 
of this section is either denied or covered only in part by the primary 
payer, the eligible individual can apply for medical monitoring, 
diagnosis, and treatment under this program.
    (d) Diagnosis and Treatment or Other Benefits-Veterans. An eligible 
individual who is enrolled, or eligible to be enrolled, in the U.S. 
Department of Veterans Affairs (VA) health care system may opt instead 
to seek his or her care and services through the VA. Under the TREAT 
Astronauts program, the eligible individual may seek reimbursement from 
NASA for any out-of-pocket copayment(s) he or she paid to VA for care 
of a condition that NASA determines is associated with spaceflight. The 
individual may also apply for disability compensation with the 
Department of Veterans Affairs, Veterans Benefits Administration, 
pursuant to 38 CFR part 3.
    (e) Submitting claims for medical monitoring, diagnosis, and 
treatment under this program--(1) Claim required. (i) No medical 
diagnosis and treatment may be extended under the TREAT Astronauts Act 
without submission of a complete claim form to the JSC Flight Medicine 
Clinic.
    (ii) NASA will provide specific forms appropriate for making a 
claim for medical monitoring, diagnosis, and treatment. Claim forms may 
be obtained from the JSC Flight Medicine Clinic. Contact information 
can be found at: https://www.nasa.gov/hhp/treat-act.

[[Page 15359]]

    (2) Information required. Each claim for medical monitoring, 
diagnosis, and treatment under this program will be in writing and 
include, at a minimum:
    (i) Statement of eligibility describing the employment and 
spaceflight history that justifies medical monitoring, diagnosis, and 
treatment under this program;
    (ii) History and diagnosis of medical or psychological condition;
    (iii) Medical documentation in support of the claim. Healthcare 
providers must be licensed and permitted to practice under state law 
and not be on the Centers for Medicare & Medicaid Services (CMS) List 
of Excluded Individuals and Entities, found at: https://healthdata.gov/dataset/list-excluded-individuals-and-entities;
    (iv) Documentation of the decisions and/or payments made by the 
primary payer (i.e., other U.S. Government agencies and/or private 
health insurer) regarding the claim;
    (v) Justification for determination that the psychological or 
medical condition is associated with spaceflight;
    (vi) Expenses for which they are seeking reimbursement, to include 
documentation of all out-of-pocket costs; and
    (vii) The signature of the eligible individual or their authorized 
representative.
    (3) Responsibility for perfecting claim. It is the responsibility 
of the eligible individual, authorized representative, or the 
authorized provider acting on behalf of the eligible individual to 
perfect a claim for submission. NASA will assist eligible individuals 
with claims submission, but is not authorized to prepare a claim on 
behalf of the eligible individual.


Sec.  1241.35  Claims review and decisions.

    (a) NASA will establish the TREAT Astronauts Act Board (TAAB) to 
review claims for medical monitoring, diagnosis, and treatment under 
this program. This review is independent of any review conducted by 
primary payers.
    (b) The TAAB will review each claim submitted by the eligible 
individual, in consultation with specialists, as appropriate. A typical 
case will be reviewed within 30 calendar days, but cases that are more 
complex may take additional time.
    (c) The TAAB will make a recommendation to the Administrator or 
designee for each claim stating whether the condition is determined to 
be spaceflight associated.
    (d) For those eligible individuals who have had other exposures in 
addition to those experienced during their career as active U.S. 
Government astronauts or payload specialists, the TAAB will consider 
that history when making its recommendation.
    (e) The NASA Administrator or designee will review each claim and 
associated TAAB recommendation to determine whether the claim should be 
approved or denied. A typical case can be reviewed within 30 calendar 
days, but cases that are more complex may take additional time.
    (f) The decision will be provided to the eligible individual within 
seven calendar days of the final decision by the NASA Administrator or 
designee. Decisions not in favor of the eligible individual will 
include information on how to request reconsideration.
    (g) An eligible individual or their authorized representative may 
request reconsideration of the decision at any time if new information 
is obtained that enhances the claim. Reconsideration requests can be 
made to the JSC Flight Medicine Clinic.
    (h) Requests for reconsideration are reviewed by the TAAB and 
decisions made by the Administrator or designee, following the same 
process described in paragraphs (b) through (f) of this section.


Sec.  1241.40  Payment of approved claims.

    (a) The NASA Administrator or designee is responsible for ensuring 
that medical monitoring, diagnosis, and treatment to eligible 
individuals under this program is paid only to the extent described in 
this part.
    (b) Payment for medical monitoring, diagnosis, and treatment is 
applied secondarily to primary payers and may include the remaining 
out-of-pocket costs from primary payer coverage.
    (c) NASA will pay necessary travel expenses related to this program 
consistent with the Federal Travel Regulations.
    (d) NASA may provide conditional payments for medical monitoring, 
diagnosis, and treatment that is obligated to be paid by the U.S. 
Government or other primary payers prior to a final decision by NASA in 
accordance with Sec.  1241.35. Such requests for conditional payments 
can be made to JSC Flight Medicine Clinic. Such payments are permitted 
when payment for such medical monitoring, diagnosis, and treatment has 
either not been made or will not be made promptly.
    (1) NASA may seek to recover costs associated with conditional 
payments from the U.S. Government, private health insurance company, or 
other primary payer as allowable by law.
    (2) If the claim is denied in accordance with Sec.  1241.35, NASA 
may seek to recover such conditional payments from the eligible 
individual in accordance with 31 U.S.C. Chapter 37.


Sec.  1241.45  Collaboration with other agencies.

    Copies of records generated from medical monitoring, diagnosis, and 
treatment collected by primary payer facilities and/or relevant health 
care providers will be acquired by NASA. NASA will collaborate with the 
Department of Defense Military Health System, Department of Veterans 
Affairs, and Department of Labor Office of Workers' Compensation and 
other entities for acquisition of copies of these medical records as 
allowed by law.


Sec.  1241.50  Records, confidentiality, privacy, and data use.

    (a) Records on individuals created or obtained pursuant to this 
regulation that are subject to the Privacy Act of 1974, as amended, 5 
U.S.C. 552a, will be maintained in accordance with the NASA's Privacy 
Act System of Records.
    (b) NASA will, as necessary, enter into data sharing agreements 
with other agencies and/or entities to receive such data and/or seek 
signed medical releases from the eligible individuals, or their 
authorized representatives, in accordance with law.
    (c) NASA's collection, use, and disclosure of this data will be in 
accordance with the Privacy Act of 1974, NASA's implementing 
regulations at 14 CFR part 1212, and NASA's privacy policies, where 
applicable.

Nanette Smith,
Team Lead, NASA Directives and Regulations.
[FR Doc. 2020-04784 Filed 3-17-20; 8:45 am]
 BILLING CODE 7510-13-P