[Federal Register Volume 88, Number 144 (Friday, July 28, 2023)]
[Notices]
[Pages 48953-48955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15928]


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DEPARTMENT OF VETERANS AFFAIRS


Implementation of the Dr. Kate Hendricks Thomas Supporting 
Expanded Review for Veterans in Combat Environments (SERVICE) Act

AGENCY: Department of Veterans Affairs.

ACTION: Notice.

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SUMMARY: The Department of Veterans Affairs (VA) is publishing this 
notice to inform the public about how it is implementing the SERVICE 
Act.

DATES: This notice is effective on July 28, 2023.

FOR FURTHER INFORMATION CONTACT: Office of Women's Health, Acting Chief 
Officer, Dr. Sally Haskell, at 202-461-7671. This is not a toll-free 
telephone number.

SUPPLEMENTARY INFORMATION: The SERVICE Act was signed into law by the 
President on June 7, 2022 (Pub. L. 117-133, 136 stat. 1238). The 
SERVICE Act amended 38 U.S.C. 7322 to ensure that certain Veterans who 
were deployed in support of a contingency operation in certain 
locations and during certain time periods can receive a breast cancer 
risk assessment and clinically appropriate mammography screening. As 
added by the SERVICE Act, 38 U.S.C. 7322(c) requires this eligibility 
expansion to be included in the national mammography policy mandated by 
subsection (a). This notice provides information on how VA will 
implement the amendments made by the SERVICE Act and is not a 
solicitation for public comment or request for information regarding 
VA's implementation of the SERVICE Act as described in this notice. 
Therefore, responses to this notice may not be used to inform VA's 
implementation of the SERVICE Act.
    VA is announcing its program for breast cancer risk assessment and 
clinically appropriate mammography screening for any individual covered 
by the SERVICE Act. VA considers the amendments made by the SERVICE Act 
to be self-executing. We will therefore issue no regulations but 
instead provide this notice to announce operationally how VA will 
implement these new authorities. This notice includes sections on 
eligible Veterans, eligible services, eligible providers and other 
matters.

Eligible Veterans

General Discussion

    The SERVICE Act includes as Veterans eligible for a breast cancer 
risk assessment and clinically appropriate mammography screening those 
Veterans who have ``a record of service in a location and during a 
period specified in subsection (d)''. See 38 U.S.C. 7322(b)(2)(B). This 
authority allows Veterans under the age of 40 who were not otherwise 
previously eligible to be included in VA's National mammography 
screening policy but who may have an elevated risk due to in-service 
toxic exposures such as an open burn pit. As amended, section 
7322(b)(2) requires VA's National policy to include Veterans who are 
over the age of 39 and Veterans, without regard to age, who have 
clinical symptoms, risk factors, a family history of breast cancer, or 
a record of service in a location and during a period specified in 
subsection (d). A record is defined as a DD Form 214, Certificate of 
Release or Discharge from Active Duty, or original Certificate of 
Discharge, military orders, service records and/or records of awards 
received. All documentation will be reviewed to determine eligibility. 
If these documents are not present, VA will follow its standard process 
to attempt retrieval of relevant documents. This information will be 
provided to Veterans in the same manner through which they contacted VA 
to request SERVICE Act care, unless the Veteran has specified a 
preferred alternate means of contact. In these cases, the policy shall, 
pursuant to section 7322(b)(3), also provide for clinician discretion 
when developing the clinical screening recommendations for the Veteran-
cohorts covered by section 7322(b)(2). Breast cancer screening 
(screening mammogram) is generally applicable only to birth sex female 
Veterans and transgender women Veterans who have been on hormone 
therapy for 5 years or more. Birth sex male Veterans who are not 
symptomatic will not be screened, but those who develop breast symptoms 
such as breast lump, breast pain, or nipple discharge will be eligible 
for a risk assessment and diagnostic mammogram.

[[Page 48954]]

Locations and Periods of Active-Duty Service

    Section 7322(d), as added by the SERVICE Act, establishes the 
following qualifying locations and service periods:
    (A) Iraq during:
    (i) The period beginning on August 2, 1990, and ending on February 
28, 1991.
    (ii) The period beginning on March 19, 2003, and ending on such 
date as the Secretary determines burn pits are no longer used in Iraq.
    (B) The Southwest Asia theater of operations, other than Iraq, 
during the period beginning on August 2, 1990, and ending on such date 
as the Secretary determines burn pits are no longer used in such 
location, including the following locations:
    (i) Kuwait.
    (ii) Saudi Arabia.
    (iii) Oman.
    (iv) Qatar.
    (C) Afghanistan during the period beginning on September 11, 2001, 
and ending on such date as the Secretary determines burn pits are no 
longer used in Afghanistan.
    (D) Djibouti during the period beginning on September 11, 2001, and 
ending on such date as the Secretary determines burn pits are no longer 
used in Djibouti.
    (E) Syria during the period beginning on September 11, 2001, and 
ending on such date as the Secretary determines burn pits are no longer 
used in Syria.
    (F) Jordan during the period beginning on September 11, 2001, and 
ending on such date as the Secretary determines burn pits are no longer 
used in Jordan.
    (G) Egypt during the period beginning on September 11, 2001, and 
ending on such date as the Secretary determines burn pits are no longer 
used in Egypt.
    (H) Lebanon during the period beginning on September 11, 2001, and 
ending on such date as the Secretary determines burn pits are no longer 
used in Lebanon.
    (I) Yemen during the period beginning on September 11, 2001, and 
ending on such date as the Secretary determines burn pits are no longer 
used in Yemen.
    (J) Such other locations and corresponding periods as set forth by 
the Airborne Hazards and Open Burn Pit Registry established under 
section 201 of the Dignified Burial and Other Veterans' Benefits 
Improvement Act of 2012 (Pub. L. 112-260; 38 U.S.C. 527, note).
    Section 7322(d)(1)(K) authorizes VA, in collaboration with the 
Department of Defense, to include such other locations and 
corresponding periods as determined appropriate in a report to Congress 
pursuant to section 7322(d)(2). At this time, VA has identified no such 
locations and has not yet submitted a report to Congress; the first 
report to Congress is due no later than June 7, 2024. VA will announce 
any added locations and periods of service, which will only be 
effective at the time of such announcement. There will be no individual 
ad hoc decisions made by VA providers, making this content self-
executing.
    Section 7322(d)(3) provides that a location under this subsection 
does not include any body of water around or any airspace above such 
location. VA has no discretion in this regard.
    Section 7322(d)(4) defines the term ``burn pit'' to mean an area of 
land that--(A) is used for disposal of solid waste by burning in the 
outdoor air; and (B) does not contain a commercially manufactured 
incinerator or other equipment specifically designed and manufactured 
for the burning of solid waste. VA has no discretion in this regard.
    For any individual who seeks a mammography screening under section 
7332(c), VA will confirm an individual's qualifying service under 
section 7332(d).

Application

    This eligibility for mammography screening in section 7322(c) is 
akin to eligibility for a registry examination. For registry 
examinations, individuals must apply for such screening. Consistent 
with this practice, VA will require individuals to apply for a 
mammography screening pursuant to section 7322. Veterans can choose to 
either apply for enrollment in VA health care or to apply only for care 
under the SERVICE Act. If Veterans are seeking SERVICE Act care only, 
they will need to check the Registration box on the 10-10EZ (under 
``Type of Benefit(s) Applying for''), and VA will then ensure they are 
placed in the system as registered only.
    VA will provide applicants an eligibility determination in 
accordance with the requirements set forth in 38 U.S.C. 5104. Eligible 
Veterans will be provided a mammogram only when clinically appropriate, 
as determined by a VA clinician. A VA clinician's decision to deny an 
eligible Veteran's request for a mammogram may be appealed under VA's 
Clinical Appeals processes.

Eligible Services

    Veterans who served in certain locations during specific periods 
identified by law, regardless of their enrollment in VA health care, 
may receive clinically appropriate mammography screening, risk 
evaluation and counseling. We recognize that without these amendments, 
asymptomatic individuals less than 40 years of age with qualifying 
service in a covered location would not likely be able to receive 
mammography screening on that basis outside the VA health care system. 
Further, section 7322(c) ensures that Veterans who are not enrolled in 
VA health care or eligible to receive VA health care without enrolling 
may receive a breast cancer risk assessment and clinically appropriate 
mammography under this Act. The screening will be furnished to all 
eligible Veterans at no cost to the individual.
    While section 7322(c) refers to eligibility for ``a mammography 
screening by a health care provider of the Department,'' this must be 
clinically indicated in the first place, and if clinically indicated, 
would require the prior, voluntary informed consent of the individual 
in accordance with 38 U.S.C. 7331 and 38 CFR 17.32. Each eligible 
individual who seeks a mammogram under section 7322(c) will receive, in 
advance of such screening, a breast cancer risk assessment to determine 
if further evaluation is clinically needed. If so, the individual will 
receive all relevant clinical information about the nature of the 
screening, their individual risk assessment for breast cancer based on 
all relevant clinical factors and histories, reasonably foreseeable 
associated risks, complications or side effects of the screening, 
reasonable and available alternatives to undergoing the screening and 
anticipated results if no screening occurs. In other words, they will 
receive all the relevant information an individual would want to make a 
full, informed, consensual decision. The determination of clinical need 
and informed consent can occur at the same encounter, but the latter is 
dependent on the former.
    Veterans seeking care under this Act are understandably concerned 
about any long-term adverse health consequences associated with any in-
service toxic exposures they may have experienced while deployed on 
active duty to a covered location, even if they are not experiencing 
symptoms. We emphasize, though, the inherent risk in undergoing 
mammography; mammography screening is not currently recommended by the 
United States Preventive Services Task Force, the American Cancer 
Society, or other agencies for average-risk women younger than 40 years 
of age because interpretation is hindered by dense breast tissue in 
young women, leading to frequent false positive results.

[[Page 48955]]

False positive results can lead to unnecessary additional imaging or 
diagnostic testing through their personal treating providers, including 
biopsies and unnecessary surgeries, the costs of which may be borne by 
the subject individual. Veterans seeking a mammography screening under 
section 7322(c) will be assessed to ensure that further evaluation is 
clinically needed, and if so, Veterans will receive a risk assessment, 
along with clinically appropriate discussions before an ultimate 
decision is made on whether to furnish a mammography.
    There are several important limitations regarding the authority in 
section 7322(c) that should be made clear. First, the expanded 
eligibility authority in section 7322(c) does not create eligibility 
for Veterans to obtain mammography screening if it is not determined to 
be clinically appropriate. Clinical necessity is a threshold 
requirement for the delivery of all care. If care is clinically, 
indicated, a patient must also provide informed consent to receive such 
care. Second, section 7322(c) does not independently authorize the 
provision of any recommended or additional needed medical care through 
VA; Veterans who are enrolled in VA health care or eligible to receive 
VA health care without enrolling may receive any necessary follow up 
care from VA, but Veterans without such eligibility can only receive 
the breast cancer risk assessment and clinically appropriate 
mammography screening as authorized by section 7322(c). Section 7322(c) 
does not authorize the delivery of any care or services for the 
treatment of breast cancer or any other condition for Veterans who are 
not enrolled in VA health care. Asymptomatic Veterans less than 40 
years of age may return for the breast cancer risk assessment and 
mammogram screening as indicated every 5 years until age 40 when they 
would become eligible for standard breast cancer screening. This is 
consistent with current national guidelines and standards. Veterans who 
are eligible for care exclusively under the SERVICE Act will be 
eligible to present for a breast cancer risk assessment and mammogram 
screening as indicated more frequently than once every 5 years at any 
time in which they develop interim symptoms such as breast lump, breast 
pain or nipple discharge. This is also consistent with current national 
guidelines and standards. Third, section 7322(c) does not establish a 
claim for service-connection. Section 7322(c) only authorizes the 
provision of a breast cancer risk assessment and mammogram screening; 
it has no effect on establishing eligibility for any other benefits.
    The American College of Radiology has established a uniform way for 
radiologists to describe mammogram findings. See https://www.cancer.gov/types/breast/mammograms-fact-sheet#what-is-the-breast-imaging-reporting-and-database-system-bi-rads. The Breast Imaging 
Reporting and Data System (BI-RADS) categories included in mammography 
reports help inform radiologists and other providers whether any 
follow-up testing, or imaging is recommended or needed, including any 
MRI imaging, biopsy, or sonagram. Id. VA will ensure the mammography 
screening performed is of the quality required for the assigned 
radiologist to reliably list the appropriate BI-RADS category. BI-RADS 
are scored from 0-6. BI-RADS 0 represents an incomplete evaluation. In 
this case, VA must perform additional imaging as needed, such as 
ultrasound, to assign a final BI-RADS category. VA may perform 
additional imaging, such as ultrasound, for all SERVICE Act eligible 
Veterans to reach a ``complete'' exam designation (BIRADS 1-6). VA is 
not authorized under the SERVICE Act to provide further care to 
Veterans based on the results of the breast cancer risk assessment and/
or clinically appropriate mammogram. If the Veteran is enrolled in VA 
health care, VA may perform the additional imaging that is required 
because of an abnormal BI-RADS (3-6). However, if the Veteran is not 
enrolled in VA health care and additional imaging is needed beyond 
establishing the final BI-RADS (such as follow up for an abnormal BI-
RADS category (3, 4, 5 or 6), VA will not be able to provide that care 
and will advise such individuals to pursue follow-up care promptly with 
their health care provider.

Eligible Providers

    Section 7332(c) establishes a Veteran's eligibility for a 
mammography screening ``by a health care provider of the Department.'' 
This language allows for screenings to be conducted by VA-authorized 
community providers who have entered into an appropriate agreement with 
VA to furnish such care. As mentioned above, many Veterans who qualify 
under section 7322(c) would not be eligible for a mammography screening 
in the community (based on applicable screening standards to which the 
health care system outside of VA is bound). Based on the Veteran's 
eligibility under section 7322(c), however, VA can provide the 
mammography screening in-house or through a contractual arrangement. 
Any service VA is authorized to provide the mammography screening, it 
may also provide by contract or agreement, subject to other applicable 
law and regulations. Veterans who are covered under the Veterans 
Community Care Program (38 U.S.C. 1703 and Sec. Sec.  17.4000 through 
17.4040 of title 38, CFR) may elect to receive their screening in the 
community if they are eligible to make such an election under that 
Program. For Veterans who are not covered for purposes of 38 U.S.C. 
1703 and Sec. Sec.  17.4000 through 17.4040 of title 38, CFR, if VA is 
not able to furnish the mammography screening itself, a VA provider 
will order such a screening to be performed, and, per the terms of the 
authorization, receive a report of the imaging results. We do not view 
this as conflicting with the language of the SERVICE Act because it is 
the VA provider who still provides this preventive health care benefit, 
even if indirectly in some cases.

Signing Authority

    Denis McDonough, Secretary of Veterans Affairs, approved and signed 
this document on July 20, 2023, and authorized the undersigned to sign 
and submit the document to the Office of the Federal Register for 
publication electronically as an official document of the Department of 
Veterans Affairs.

Jeffrey M. Martin,
Assistant Director, Office of Regulation Policy & Management, Office of 
General Counsel, Department of Veterans Affairs.
[FR Doc. 2023-15928 Filed 7-27-23; 8:45 am]
BILLING CODE 8320-01-P