Rule2022-10545
TRICARE Coverage and Reimbursement of Certain Services Resulting From Temporary Program Changes in Response to the COVID-19 Pandemic
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 1, 2022
Effective
July 1, 2022
Issuing agencies
Defense Department
Abstract
The Assistant Secretary of Defense for Health Affairs (ASD(HA)) issues this final rule related to certain provisions of three TRICARE interim final rules (IFRs) with request for comments issued in 2020 in response to the novel coronavirus disease 2019 (COVID-19) public health emergency (PHE). Temporary coverage of telephonic office visits is made permanent in this final rule, with its adoption expanded beyond the pandemic; the temporary telehealth cost-share waiver is terminated; and the temporary waiver of certain acute care hospital requirements and permanent adoption of Medicare New Technology Add-on Payments for new medical items and services are modified, as further discussed in the SUPPLEMENTARY INFORMATION section of this rule
Full Text
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<title>Federal Register, Volume 87 Issue 105 (Wednesday, June 1, 2022)</title>
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[Federal Register Volume 87, Number 105 (Wednesday, June 1, 2022)]
[Rules and Regulations]
[Pages 33001-33015]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-10545]
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DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[Docket ID: DoD-2020-HA-0040; and DoD-2020-HA-0050]
RIN 0720-AB81; 0720-AB82; and 0720-AB83
TRICARE Coverage and Reimbursement of Certain Services Resulting
From Temporary Program Changes in Response to the COVID-19 Pandemic
AGENCY: Office of the Assistant Secretary of Defense for Health
Affairs, Department of Defense (DoD).
ACTION: Final rule.
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SUMMARY: The Assistant Secretary of Defense for Health Affairs
(ASD(HA)) issues this final rule related to certain provisions of three
TRICARE interim final rules (IFRs) with request for comments issued in
2020 in response to the novel coronavirus disease 2019 (COVID-19)
public health emergency (PHE). Temporary coverage of telephonic office
visits is made permanent in this final rule, with its adoption expanded
beyond the pandemic; the temporary telehealth cost-share waiver is
terminated; and the temporary waiver of certain acute care hospital
requirements and permanent adoption of Medicare New Technology Add-on
Payments for new medical items and services are modified, as further
discussed in the SUPPLEMENTARY INFORMATION section of this rule
DATES: This rule is effective July 1, 2022, except for instruction 4
(the provision modifying temporary hospitals) which is effective on
June 1, 2022. Effective July 1, 2022 the interim final rules amending
32 CFR part 199, which were published at 85 FR 27921, May 12, 2020, and
85 FR 54914, September 3, 2020, are adopted as final with changes,
except for the note to paragraph 199.4(g)(15)(i)(A), published at 85 FR
54923, September 3, 2020, which remains interim.
FOR FURTHER INFORMATION CONTACT: Erica Ferron, Defense Health Agency,
Medical Benefits and Reimbursement Section, 303-676-3626 or
<a href="/cdn-cgi/l/email-protection#294c5b404a48074a074f4c5b5b4647074a405f694448404507444045"><span class="__cf_email__" data-cfemail="acc9dec5cfcd82cf82cac9dedec3c282cfc5daecc1cdc5c082c1c5c0">[email protected]</span></a>. Sharon Seelmeyer, Defense Health Agency,
Medical Benefits and Reimbursement Section, 303-676-3690 or
<a href="/cdn-cgi/l/email-protection#97c4fff6e5f8f9b9fbb9e4f2f2fbfaf2eef2e5b9f4fee1d7faf6fefbb9fafefb"><span class="__cf_email__" data-cfemail="a0f3c8c1d2cfce8ecc8ed3c5c5cccdc5d9c5d28ec3c9d6e0cdc1c9cc8ecdc9cc">[email protected]</span></a>, Diagnosis Related Groups, Hospital
Value Based Purchasing, Long Term Care Hospitals, and New Technology
Add-On Payments.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Purpose of the Rule
In response to the novel coronavirus (SARS-CoV-2), which causes
COVID-19, and the President's declared national emergency for the
resulting pandemic (Proclamation 9994, 85 FR 15337 (March 18, 2020)),
the ASD(HA) issued three IFRs in 2020 to make temporary modifications
to TRICARE regulations in order to better respond to the pandemic. The
first IFR, published in the FR on May 12, 2020 (85 FR 27921),
temporarily: (1) Modified the TRICARE regulations to allow for coverage
of medically necessary telephonic (audio-only) office visits; (2)
permitted interstate and international practice by TRICARE providers
when such practice was permitted by state, federal, or host-nation law;
and (3) waived cost-shares and copayments for covered telehealth
services for the duration of the COVID-19 pandemic.
The second IFR, published in the FR on September 3, 2020 (85 FR
54914) temporarily: (1) Waived the three-day prior hospital qualifying
stay requirement for skilled nursing facilities (SNFs); (2) added
coverage for the treatment use of investigational drugs under expanded
access authorized by the U.S. Food and Drug Administration (FDA) when
indicated for the treatment of COVID-19; (3) waived certain provisions
for acute care hospitals in order to permit TRICARE authorization of
temporary hospital facilities and freestanding ambulatory surgical
centers (ASCs) providing inpatient and outpatient services to be
reimbursed; (4) revised the diagnosis related group reimbursement (DRG)
at a 20 percent higher rate for COVID-19 patients; and (5) waived
certain requirements for long term care hospitals (LTCHs). The second
IFR also included two permanent provisions adopting Medicare's NTAPs
adjustment to DRGs for new medical services and technologies and
adopting Medicare's Hospital Value Based Purchasing (HVBP) Program.
The third IFR, published in the FR on October 30, 2020 (85 FR
68753) added coverage of National Institute of Allergy and Infectious
Disease (NIAID)-sponsored clinical trials when for the prevention or
treatment of COVID-19 or its associated sequelae.
After publication of each IFR, DoD evaluated the appropriateness of
each temporary measure for continued use throughout the national
emergency for COVID-19, as well as to determine if it would be
appropriate to make any of the provisions permanent within the
[[Page 33002]]
TRICARE program. After analysis of the risks, benefits, and costs of
each provision, as well as a review of comments, the ASD(HA) issues
this final rule to make the following changes:
a. 32 CFR 199.4(g)(52) Telephone Services: The IFR temporarily
modified this regulation provision which excluded telephone services
(audio-only) except for biotelemetry. This final rule revises this
regulatory exclusion and permanently modifies 32 CFR 199.4(c)(1)(iii)
Telehealth Services to add coverage for medically necessary telephonic
office visits, in all geographic areas where TRICARE beneficiaries
reside. A telephonic office visit is a reimbursable telephone call
between a beneficiary, who is an established patient, and a TRICARE-
authorized provider. This is considered a type of telehealth modality
under the TRICARE program. Specifically, this change will allow
providers to be reimbursed for medically necessary care and treatment
provided to beneficiaries over the telephone, when a face-to-face,
hands-on visit is not required, and a two-way audio and video
telehealth visit is not possible. The telephonic office visit should be
a valid medical visit in that there is an examination of the patient's
history and chief complaint along with clinical decision making
performed by a provider. Telephonic provider-to-provider consults which
are audio-only, but otherwise meet the definition of a covered
consultation service are also covered under this final rule. Telephone
calls of an administrative nature (e.g., appointment scheduling),
routine answering of questions, prescription refills, or obtaining test
results are not medical services and are not reimbursable.
DoD implemented temporary coverage of telephonic office visits
effective May 12, 2020, in order to provide beneficiaries the option to
obtain some medical services safely from home, reducing their exposure
to COVID-19 and to minimize potential spread of the illness. In order
to determine if telephonic office visits should be converted to a
permanent telehealth benefit, DoD analyzed claims data from TRICARE
private sector care and reviewed published industry information from:
Medicare; health insurance plans; and physicians' professional
organizations regarding telephonic office visits. The TRICARE claims
data between mid-March and mid-September 2020 indicates beneficiary
utilization of telephonic office visits is a small portion of all
telehealth claims. Medicare and health insurance plans reported data
indicating substantial utilization of telephonic office visits.
Physicians' professional organizations including the American College
of Physicians (ACP) and the American Medical Association (AMA) issued
statements reporting physicians' favorable experiences with telephonic
office visits. Furthermore, the DoD received positive public comments
regarding telephonic office visits including multiple requests for the
agency to consider it as a permanent benefit. After thoughtful
consideration of these facts, and through this final rule revising the
regulatory exclusion prohibiting reimbursement of telephonic (audio-
only) office visits, the DoD will revise the exclusion of audio-only
telephonic services and add medically necessary telephonic office
visits as a covered telehealth service under the TRICARE Basic Benefit.
In addition, 32 CFR 199.2 Definitions will be amended by this final
rule to include definitions of ``Biotelemetry,'' ``Telephonic
consultations,'' and ``Telephonic office visits'' as related to the
modified telehealth service regulation provision.
b. 32 CFR 199.6(b)(4)(i)(I): The temporary waiver of certain acute
care hospital requirements for temporary hospitals and freestanding
ambulatory surgery centers during the COVID-19 pandemic from the second
COVID IFR remains in effect, with modifications. The modification
temporarily allows any entity that enrolled with Medicare as a hospital
through Medicare's Hospitals Without Walls initiative to become a
TRICARE-authorized hospital that may be considered to meet the
requirements for an acute care hospital listed under paragraph
199.6(b)(4)(i). These entities may provide any inpatient or outpatient
hospital services, when consistent with the State's emergency
preparedness or COVID-19 pandemic plan and when they meet the Medicare
hospital Conditions of Participation (CoP), to the extent not waived.
Under Medicare's Hospitals Without Walls initiative, Centers for
Medicaid and Medicare Services (CMS) relaxed certain requirements to
allow ASCs and other interested entities, such as licensed independent
emergency departments, to temporarily enroll as Medicare-certified
hospitals and receive reimbursement for hospital inpatient and
outpatient services. Although CMS ceased accepting new enrollments into
the Hospitals Without Walls initiative, effective December 1, 2021,
those entities that were previously enrolled under the initiative
continue to be enrolled and receive reimbursement for hospital
inpatient and outpatient services. The CMS memorandum eliminating
future enrollments into the Hospitals Without Walls initiative, does
not impact any of the changes from the initial IFR or in this final
rule, as both require a provider to first be enrolled with CMS as a
hospital under the initiative to register with TRICARE as a hospital
and receive reimbursement as a hospital.
The ASD(HA) also recognizes the need for increased access to
inpatient and outpatient care during the COVID-19 pandemic. In the IFR,
we temporarily permitted temporary hospitals and freestanding ASCs that
registered with Medicare as hospitals to be reimbursed as acute care
hospitals (85 FR 54914). We are modifying this expanded coverage of
inpatient and outpatient care by allowing any entity enrolled with
Medicare as a hospital on a temporary basis to also be considered a
TRICARE-authorized hospital and receive reimbursement for inpatient and
outpatient institutional charges under the TRICARE DRG payment system,
Outpatient Prospective Payment System (OPPS), or other applicable
hospital payment system allowed under Medicare's Hospitals Without
Walls initiative, to the extent practicable. In order to reduce burden
on these providers during the pandemic, we are not developing any
regulatory requirements for participation in TRICARE and will instead
permit any entity that registers with Medicare as a hospital under
their Hospitals Without Walls initiative to be considered a TRICARE-
authorized hospital. To further reduce the burden on providers and the
TRICARE program, this final rule will allow the Defense Health Agency
(DHA) to adopt any requirement related to Medicare's Hospital without
Walls initiative through administrative policy, when determined
practicable, without going through the lengthy regulatory process. This
provision will be effective the date published in the FR through the
expiration of Medicare's Hospitals Without Walls initiative. Upon
conclusion of Medicare's initiative or when a facility loses its
hospital status with Medicare, whichever occurs earlier, the entity
will no longer be considered an authorized hospital under TRICARE and
will not be reimbursed for institutional charges unless it otherwise
qualifies as an authorized institutional provider under paragraph
199.6(b)(4). While vaccination has slowed the spread of COVID-19 in
many areas of the U.S., the virus remains a deadly threat for those
patients who do contract it and require acute care treatment.
Additionally,
[[Page 33003]]
access to acute care treatment for other injury and illnesses in areas
where there is a COVID-19 resurgence remains essential. The ASD(HA)
finds it necessary to make this provision of the final rule effective
upon publication of the final rule.
c. 32 CFR 199.14(a)(1)(iv): Special Programs and Incentive
Payments. This final rule creates new paragraph 199.14(a)(1)(iv) to
more appropriately categorize the NTAP and HVBP payments. It moves the
NTAP provisions from paragraph 199.14(a)(1)(iii)(E)(5) to
199.14(a)(1)(iv)(A), and moves the HVBP provision from paragraph
199.14(a)(iii)(E)(6) to 199.14(a)(1)(iv)(B). For the NTAP provisions,
TRICARE: (1) Shall apply Medicare NTAP adjustments to TRICARE covered
services and supplies, except for pediatric (defined for NTAPs as
pertaining to patients under the age of 18, or who are treated in a
children's hospital or in a pediatric ward) services and supplies; (2)
shall modify NTAP reimbursement adjustment rates for NTAPs at 100
percent of the average cost of the technology or 100 percent of the
costs in excess of the Medicare Severity-Diagnosis Related Group (MS-
DRG) payment for the case for pediatric beneficiaries; and (3) may
create a reimbursement adjustment for TRICARE NTAPs, specific to the
TRICARE beneficiary population under age 65 in the absence of a
Medicare NTAP adjustment, using criteria similar to Medicare criteria
for eligible new technologies outlined in 42 CFR 412.87 and the
Medicare reimbursement criteria outlined in 42 CFR 412.88. Under the
statutory authority to pay like Medicare for like services and items
when practicable in 10 U.S.C. 1079(i)(2), the ASD(HA) has determined
that, generally, the NTAP reimbursement methodology is practicable for
TRICARE to adopt for any otherwise covered services and supplies with a
Medicare NTAP, under the same conditions as approved by Medicare.
However, the ASD(HA) finds it impracticable to use Medicare's NTAPs for
TRICARE's pediatric patients due to the lack of a significant pediatric
population within Medicare. To address the unique TRICARE beneficiary
population of pediatric patients, this rule establishes reimbursement
of pediatric NTAPs at 100 percent of the costs in excess of the MS-DRG
payment. Lastly, when TRICARE covers new technologies that are not
covered by Medicare or do not have a Medicare NTAP due to differing
populations (e.g., biologics used solely by pediatric patients), the
ASD(HA) finds it practicable to establish a TRICARE NTAP category and
methodology whenever necessary. In these instances, the Director, DHA,
may issue implementation instructions listing the specific TRICARE
NTAPs on the website: <a href="http://www.health.mil/ntap">www.health.mil/ntap</a>.
d. 32 CFR 199.17(l)(3): The cost-share and copayment waiver for
telehealth services during the COVID-19 pandemic was implemented in
TRICARE's first COVID-19 IFR in response to efforts by federal, state,
and local governments to encourage individuals to stay at home, avoid
exposure, and to reduce possible transmission of the virus. When the
rule was published, there was a high degree of uncertainty surrounding
the potential availability of a vaccine. With the approval or emergency
use authorization of several vaccines by the U.S. Food and Drug
Administration, the widespread availability of such vaccines throughout
the United States, and the elimination of stay-at-home orders by most
States and localities, this provision is no longer necessary. As such,
the ASD(HA) is terminating the waiver of cost-shares and copayments for
telehealth services on the effective date of this final rule, or upon
expiration of the President's national emergency for COVID-19,
whichever occurs earlier.
e. The DoD continues to evaluate potential permanent adoption of
the treatment use of investigational drugs under expanded access and
NIAID-sponsored clinical trials and will publish a final rule at a
future date; until such publication, the two benefits remain in effect
without modification as temporarily implemented in the second and third
IFRs. These two benefits remain in effect through the end of the
President's national emergency for COVID-19, unless modified by future
rulemaking. Comments received on those two provisions during the IFR
comment periods will be addressed in that final rule.
f. All temporary regulation changes made by the three COVID-19-
related IFRs not otherwise addressed in this final rule remain in
effect as stated in the IFR under which they were implemented until
such time as the conditions for their expiration are met.
g. The HVBP Program is permanently adopted and is moved from 32 CFR
199.14(a)(1)(iii)(E)(6) to 32 CFR 199.14(a)(1)(iv)(B); there are
otherwise no modifications from the second IFR.
B. Summary of Major Provisions
a. Changes to the TRICARE Benefit
Telephonic Office Visits
A telephonic office visit is an easy-to-use telehealth modality
that has many benefits. A telephonic office visit consists of a
beneficiary, who is an established patient, calling his/her provider to
discuss an illness (including mental illness), injury, or medical
condition. During the conversation the provider will ask questions
regarding the symptoms and determine if they can proceed with the
telephonic office visit or if based on the information he/she reported,
a face-to-face, hands-on visit is in fact medically necessary. If they
proceed with the telephonic office visit, typically the provider will
have the beneficiary's medical record open for review during the call,
offer medical advice, and may place an order for a prescription or lab
tests. During the COVID-19 pandemic, telephonic office visits have been
instrumental in keeping beneficiaries safer at home with less risk of
exposure to COVID-19 for conditions which a face-to-face and hands-on
visit is not medically necessary. Telephonic office visits are also
highly desirable for beneficiaries who reside in rural areas and/or
areas where health care services are scarce. Likewise, beneficiaries
without access to the internet and/or computers, smartphones, or
tablets to conduct two-way audio-video telehealth visits also greatly
benefit from coverage of telephonic office visits. DoD will continue to
offer coverage of telephonic office visits through the end of the
pandemic and with this final rule DoD will revise the telephone
services (audio-only) regulatory exclusion in order to make this a
permanent telehealth benefit available to beneficiaries in all
geographic locations, when such care is medically necessary and
appropriate.
To understand the use of telephonic office visits during the COVID-
19 pandemic, the DoD analyzed claims data from TRICARE private sector
care and reviewed published industry information from: Medicare; health
insurance plans; and physicians' professional organizations regarding
telephonic office visits. TRICARE private sector claims data from mid-
March 2020 through mid-September 2020 indicates there were a total of
80,541 telephonic office visits conducted. Telephonic office visits
were an average 2.1 percent of all telehealth services provided.
Telehealth services were 5.7 percent of all outpatient professional
visits. In August 2020, a Medicare Advantage Issue Brief
[[Page 33004]]
reported, ``Three million telehealth visits with Medicare beneficiaries
between mid-March and mid-June were conducted via telephone indicating
the preference for [telephonic office visits].'' \1\ Health insurance
plans including Security Health Plan and Kaiser Permanente reported 75
percent and 85 percent respectively of their telehealth visits as
telephonic office visits.\2\ The AMA stated, ``Doctors have reported
that they have been able to conduct successful [telephonic office
visits] with patients, in lieu of in-person or telehealth visits,
obtaining about 90 percent of the information they would collect using
audio and video capable equipment.'' \3\ In March 2020, the ACP began
writing letters to CMS requesting pay parity for telephonic office
visits. On April 30, 2020, CMS responded to the ACP's requests
announcing that it was increasing payments for telephonic office visits
to match payments of similar office and outpatient visits.\4\ TRICARE
routinely updates its reimbursement rates in accordance with CMS
updates, consistent with existing statutory requirements, when
practicable. Note that CMS intends to only temporarily offer coverage
for telephonic office visits for certain services during the public
health emergency. However, although TRICARE is required to reimburse
like Medicare to the extent practicable under the statute, TRICARE is
not required to provide the exact same benefits as Medicare given the
differences in populations served. Prior to the pandemic, DoD had a
telehealth benefit that was more generous than what was offered under
Medicare. Considering all of the data and industry information
discussed, the DoD is finalizing its approach to permanently revise the
telephone services (audio-only) regulatory exclusion and allow coverage
of medically necessary and appropriate telephonic office visits for
beneficiaries in all geographic locations.
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\1\ ``Issue Brief: Audio-only Telehealth Visits Essential for
Use in Medicare Advantage Risk Adjustment'', Better Medicare
Alliance. August 2020. Web. Accessed 15 Dec. 2020.
\2\ Ibid.
\3\ ``Amid pandemic, CMS should level field for phone E/M
visits'', Kevin B. O'Reilly, AMA Digital, April 20, 2020. Web.
Accessed 15 Dec. 2020
\4\ ``CMS Announcement of Pay Parity for Telephone Calls Answers
a TOP ACP Priority'' American College of Physicians. Statement
attributable to Jacqueline Fincher, President, American College of
Physicians. April 30, 2020. Web. Accessed 15 Dec. 2020.
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In converting medically necessary telephonic office visits to a
permanent benefit, the DoD will issue policy guidance describing
coverage of medically necessary and appropriate telephonic office
visits to ensure best practices and protect against fraud.
Entities Temporarily Enrolling as Hospitals
This final rule modifies the temporary waiver of certain acute care
hospital requirements for TRICARE authorized hospitals in the IFR to
allow any entity that has temporarily enrolled with Medicare as a
hospital through their Hospitals Without Walls initiative (or enrolls
in the future, should Medicare resume such enrollments) to temporarily
become a TRICARE-authorized hospital under paragraph 199.6(b)(4)(i).
These entities may provide any inpatient or outpatient hospital
services, when consistent with the State's emergency preparedness or
COVID-19 pandemic plan and when they meet the Medicare hospital CoP, to
the extent not waived. While there are no direct corollaries in TRICARE
regulation to the CoP being waived under Medicare, there do exist in
TRICARE regulation certain requirements that would prevent allowing
some facilities to be considered as acute care hospitals for the
purposes of payment. Title 32 CFR 199.6(b)(3) and (4) list the
requirements for providers to be considered TRICARE-authorized
hospitals. It may not be possible for some entities to meet all of
these requirements, such as providing primarily inpatient care or
having Joint Commission (previously known as the Joint Commission on
Accreditation of Hospitals) accreditation status or surveying of new
facilities.
We continue to assert, as we did in the IFR, that these
institutional requirements are necessary for TRICARE-authorized acute
care hospitals. We also note there is no requirement to have a TRICARE
benefit that matches Medicare's benefit, or for TRICARE to authorize
all providers that are providers under Medicare. Both TRICARE's
statutory authority and population differ from Medicare's, so it is
appropriate for TRICARE to continue to manage its authorized provider
program separately from Medicare's. During the COVID-19 pandemic,
however, it is important for TRICARE to ensure swift access to
inpatient and outpatient care, to include leveraging Medicare's
flexibilities for acute care facilities. Under Medicare's Hospitals
Without Walls initiative, CMS relaxed certain requirements to allow
ASCs and other interested entities, such as licensed independent
freestanding emergency departments, to temporarily enroll as Medicare-
certified hospitals and to receive reimbursement for hospital inpatient
and outpatient services. In the previously-published IFR, we extended
coverage of acute care hospitals to include temporary hospitals and
freestanding ASCs that registered with Medicare as hospitals to be
reimbursed as hospitals under TRICARE. This final rule expands the
original temporary hospital waiver by temporarily permitting any entity
to qualify as an acute care hospital under TRICARE so long as it had
enrolled with Medicare as a hospital under the Hospitals Without Walls
initiative prior to the December 1, 2021 memorandum by which CMS
terminated further enrollments (or enrolls in the future, should CMS
resume enrollments).
In the IFR, it was not our intent to maintain a regulatory list of
qualifying providers in Sec. 199.6 that are eligible to enroll with
Medicare under their Hospitals Without Walls initiative or to adopt
such changes through the regulatory process, which imposes an
unnecessary administrative burden on the DHA and delays coverage for
providers and patients, as paragraph 199.6(b)(4)(i) may need to be
continually updated to keep current with Medicare changes during the
pandemic. Therefore, this final rule modifies the temporary regulation
change from the IFR at paragraph 199.6(b)(4)(i) to allow any entity
enrolled with Medicare as a hospital to temporarily become a TRICARE-
authorized acute care hospital, and receive reimbursement for inpatient
and outpatient institutional charges under the TRICARE DRG payment
system, OPPS, or other applicable hospital payment system allowed under
Medicare's Hospitals Without Walls initiative (when determined
practicable). The ASD(HA) will implement Medicare's requirements for
such entities through administrative guidance (e.g., the TRICARE
manuals) to ensure TRICARE requirements for such facilities are
consistent with the most current Medicare requirements under the
Hospitals Without Walls initiative.
Under this provision, facilities that convert into hospitals and
are Medicare-certified hospitals through an emergency waiver authority
under Section 1135 of the Social Security Act and are operating in a
manner consistent with their State's emergency plan in effect during
the COVID-19 pandemic will be eligible for reimbursement by TRICARE for
covered inpatient and outpatient services under the applicable hospital
payment system. Once an entity ends, terminates, or loses its hospital
status under Medicare, the facility will no longer be considered a
TRICARE-authorized acute care hospital effective the date when Medicare
[[Page 33005]]
deactivated the entity's hospital billing privileges. While we are
temporarily amending the institutional provider requirements under
paragraph 199.6(b)(4)(i), we are still requiring that these facilities
meet Medicare's CoP (to the extent not waived) established for this
Presidential national emergency. This change will improve beneficiary
access to medically necessary care and may mitigate hospitals' lack of
capacity and shortages of resources during the pandemic. This change is
temporary for the duration of Medicare's ``Hospitals Without Walls''
initiative.
b. Reimbursement Modifications Consistent With Medicare Requirements
NTAPs
NTAP Reimbursement
As stated in the second IFR (85 FR 54914), for care rendered in an
inpatient setting, TRICARE shall reimburse services and supplies with
Medicare NTAPs using Medicare's NTAP payment adjustments for only those
services and supplies that are an approved benefit under the TRICARE
Program. Title 10 U.S.C. 1079(i)(2) requires TRICARE to reimburse
covered services and supplies using the same reimbursement rules as
Medicare, when practicable. However, this provision is not self-
executing, so this FR permanently adopts the Medicare NTAP methodology.
TRICARE shall also adopt future NTAP modifications published by CMS,
including modifications to the NTAP methodology and the list of new
technologies to which NTAPs are applied.
Pediatric Reimbursement
Per the authority provided in 10 U.S.C. 1079(i)(2), the ASD(HA) may
determine that the Medicare NTAP methodology is not practicable for
certain populations. One such population is TRICARE's pediatric
population, which, as used in relation to the NTAP provisions in this
final rule, is defined as individuals under the age of 18, or who are
being treated in a children's hospital or in a pediatric ward. Since
Medicare does not have a pediatric population to consider when
establishing alternative reimbursements for new high-dollar
technologies, the ASD(HA) has therefore determined it is not
practicable to use Medicare's NTAPs for pediatric patients; instead,
the NTAP adjustment should be modified to address the unique TRICARE
beneficiary population of pediatric patients. Under this modification,
TRICARE shall reimburse pediatric NTAP claims at 100 percent of the
costs in excess of the MS-DRG. Paying these claims at 100 percent of
the costs in excess of the MS-DRG increases the likelihood that all
pediatric beneficiaries will receive medically necessary and
appropriate treatment, especially pediatric beneficiaries with serious,
life-threatening, and costly diseases.
High-Cost Treatments Without an NTAP
Some new, high-cost treatments are not identified as requiring an
NTAP by CMS. This primarily occurs when a treatment for a rare, fatal
disease may be appropriate for a beneficiary in TRICARE's population
but is not appropriate for Medicare's population, which is typically
age 65 and above. For example, Spinraza is a treatment for Spinal
Muscular Atrophy, a rare genetic neuromuscular disease that primarily
impacts infants and young children. Spinraza has a high-cost per
treatment, but is reimbursed at substantially lower cost when
administered in a hospital because it is included in the DRG
reimbursement. CMS does not include Spinraza in its list of new
technologies receiving an NTAP.
The ASD(HA) therefore finds it impracticable to reimburse such
technologies using existing reimbursement methodologies, which do not
allow sufficient rates for new, high-cost technologies during the first
two or three years following FDA approval, after which, they are
absorbed into the core DRG through the annual DRG update and
calibration process. The ASD(HA) finds it practicable to establish a
category of TRICARE NTAPs. This category may include services and
supplies that are otherwise covered by TRICARE and that meet certain
CMS eligibility criteria under 42 CFR 412.87. These eligibility
criteria will ensure that DHA consistently and comprehensively
evaluates new treatments when selecting which treatments may be
approved for a TRICARE NTAP. Likewise, the reimbursement methodology
for these TRICARE NTAPs shall follow the CMS reimbursement
methodologies for Medicare NTAPs outlined in 42 CFR 412.88.
For these high-cost, new, life-saving treatments that do not
qualify or otherwise have an NTAP designation from CMS but for which
the existing Medicare reimbursement is not practicable for the TRICARE
population, the Director, DHA, shall establish internal guidelines and
policy for approving TRICARE NTAPs and adopting such adjustments
together with any variations deemed necessary to address unique issues
involving the beneficiary population or program administration. These
include, but are not limited to the exact reimbursement methodology,
the eligibility criteria, and the method for approving or denying a
TRICARE specific NTAP. The approved TRICARE NTAPs shall be published at
least annually on the website: <a href="http://www.health.mil/ntap">www.health.mil/ntap</a>.
c. Beneficiary Cost-Shares and Copayments
Termination of Cost-Share and Copayment Waivers for Telehealth During
the COVID-19 Pandemic
The first IFR implemented a waiver of cost-shares and copayments
(including deductibles) for all in-network authorized telehealth
services for the duration of the COVID-19 pandemic (ending when the
President's national emergency for COVID-19 is suspended or terminated,
in accordance with applicable law and regulation). The purpose was to
incentivize TRICARE beneficiaries to use telehealth services and avoid
unnecessary in-person TRICARE-authorized provider visits, which could
potentially bring them into contact with or aid the spread of COVID-19.
The implementation of this provision was highly successful, with a
significant number of beneficiaries shifting to the use of telehealth
visits. Since this provision was enacted, however, several vaccines
have been approved or granted emergency use authorization by the FDA
and are now widely available throughout the United States. While
concerns remain surrounding variants of the SARS-CoV-2 virus and herd
immunity may not yet have been reached, states and localities are no
longer enacting strict stay-at-home orders.
TRICARE spent approximately $20.6M on waived telehealth cost-shares
and copayments in FY20 and another $71.4M through the end of September
2021. Due in part to flexibilities introduced in the IFRs discussed in
this rule, and other program changes implemented via policy, the
Defense Health Plan faces significant budget shortfalls. Termination of
this provision will save the DoD $4.8M for every month it expires prior
to the end of the national emergency, allowing DoD to focus resources
on testing, vaccination efforts, and treatment for COVID-19-positive
patients. We do not expect termination of this provision to have any
impact on access to care, as beneficiaries will continue to have access
to telehealth services and will be able to choose to continue using
such services, or to visit their provider in-person, with the same
cost-share applied to the service regardless of the
[[Page 33006]]
modality through which it was delivered.
Given the availability of vaccines, the reduction of stay-at-home
orders, and the cost of waiving telehealth cost-sharing, the ASD(HA)
finds it appropriate to expire the waiver on the effective date of this
rule or the date of expiration of the President's national emergency
for COVID-19, whichever is earlier. Telehealth services remain a
covered benefit for TRICARE beneficiaries after the expiration of the
cost-share/copayment waiver.
C. Legal Authority for This Program
This rule is issued under 10 U.S.C. 1073(a)(2) giving authority and
responsibility to the Secretary of Defense to administer the TRICARE
program. The text of 10 U.S.C. chapter 55 can be found at <a href="https://manuals.health.mil/">https://manuals.health.mil/</a>.
II. Regulatory History
Each of the sections under which TRICARE is administered are
revised every few years to ensure requirements continue to align with
the evolving health care field. Title 32 CFR 199.4 was most recently
updated on November 17, 2020 (85 FR 73193) by a final rule that added
coverage of physical therapy and occupational services prescribed by a
podiatrist.
The telephone services paragraph being modified by this final rule,
paragraph 199.4(g)(52), was last temporarily modified with publication
of the COVID-19-related IFR published on May 12, 2020 (85 FR 27921-
27927), which temporarily permitted coverage of telephonic office
visits for the duration of the President's national emergency for the
COVID-19 pandemic. The telephone services regulatory exclusion was
first published in the FR on April 4, 1977, with the comprehensive
regulations implementing the ``Civilian Health and Medical Program of
the Uniformed Services'' (42 FR 17972). Then, in 1984, the final rule,
``Civilian Health and Medical Program of the Uniformed Services
(CHAMPUS); Cardiac Pacemaker Telephonic Monitoring'' (49 FR 35934)
revised the exclusion to allow coverage of transtelephonic monitoring
(a type of biotelemetry) of cardiac pacemakers. No other permanent
revisions have been made to the telephone services paragraph.
Title 32 CFR 199.6 was last modified November 17, 2020 (85 FR
73196). This change updated terminology from doctors of podiatry or
surgical chiropody to doctors of podiatric medicine or podiatrists and
added podiatrists to the list of providers authorized to prescribe and
refer beneficiaries to physical therapists and occupational therapists.
Title 32 CFR 199.14 was last permanently revised on September 3,
2020 (85 FR 54914-54924) with the addition of NTAPs and the HVBP
Program under paragraph 199.14(a)(1)(iii)(E), which are being modified
by this final rule.
Title 32 CFR 199.17 was last temporarily modified on May 12, 2020
(85 FR 27921-27927), with publication of the telehealth cost-share and
copayment waiver being terminated by this final rule. This section was
last permanently modified on February 15, 2019 (84 FR 4333), as part of
the final rule implementing the TRICARE Select benefit plan. The
revisions to Sec. 199.17 included adding high-value services as a
benefit under the TRICARE program, as well as copayment requirements
for Group B beneficiaries. The 32 CFR 199.17(l) paragraph being
modified by this IFR was created as part of the IFR that established
the TRICARE Select benefit (82 FR 45438) during which a comprehensive
revision of Sec. 199.17 occurred. This paragraph did not exist prior
to that revision and has only been modified once, with the addition of
temporary telehealth cost-shares and copayment waivers.
III. Discussion of Comments & Changes
DoD sincerely appreciates all comments received on the IFRs
published in response to the COVID-19 pandemic. We respond to comments
for two of the IFRs below, separated by rule and impacted provision,
except for comments on the treatment use of investigational new drugs,
which will be discussed in a future final rule. We will also respond to
comments related to TRICARE's third IFR published in 2020 in a future
final rule. Except where otherwise modified in this final rule, we
reaffirm the policies and procedures incorporated in the IFRs and
incorporate the rationale presented in the preambles of the IFRs into
this final rule.
A. IFR--TRICARE Coverage and Payment for Certain Services in Response
to the COVID-19 Pandemic
This IFR was published in the FR (85 FR 27921) on May 12, 2020.
Comments were accepted for 30 days until June 11, 2020. A total of 16
comments were received. Below is a summary of the comments and the
Department's responses. Some commenters provided detailed feedback
concerning the overall telehealth program, including its applicability
to autism services, partial hospitalization programs, and behavioral
health services, or regarding benefits outside of the scope of this
rule, such as care provided in patients' homes. We thank the commenters
for their feedback however, because these comments did not relate to
telephonic office visits, provider licensing, or telehealth copays, we
are unable to respond in detail to these comments. One commenter
expressed concern about the use of nine months in the cost estimate and
that provisions would expire after nine months. We note that the
timeframe used for the cost estimates was based on early estimates for
the pandemic and that each provision of the IFR only expires when the
President's national emergency expires, except where modified by this
final rule. There was no automatic expiration at nine months.
a. Telephonic Office Visits
1. Provisions of the IFR
The IFR allowed TRICARE beneficiaries to obtain telephonic office
visits with providers for otherwise-covered, medically necessary care
and treatment and allowed reimbursement to those providers during the
COVID-19 pandemic. It provided a temporary exception to the regulatory
exclusion prohibiting telephone services.
2. Analysis of Public Comments
The public comments regarding the temporary exception to the
regulatory exclusion prohibiting telephone services were minimal.
Commenters requested that DoD continue coverage of telephonic office
visits after the COVID-19 pandemic and commenters requested telephonic
office visits be expanded to a range of providers. This final rule
includes regulatory text revising the prohibition on telephone services
thereby allowing coverage of telephonic office visits permanently. This
will include mental health and addiction treatment services when
medically necessary and appropriate. Regarding the request to expand
the range of providers who can provide telephonic office visits, there
is nothing in TRICARE regulation or policy excluding specific provider
types such as physical therapists, occupational therapists, registered
dieticians, or diabetes counselors (note: Diabetes counselors must be
registered dieticians to be TRICARE-authorized providers) from
providing their services via telehealth, including telephonic office
visits, so long as they otherwise meet program requirements, including
that all care be medically necessary and appropriate.
Two commenters requested DoD make implementation of the telephonic
office
[[Page 33007]]
visits retroactive, to either January 1, 2020, or March 1, 2020. The
commenters noted that CMS adopted their allowance of telephonic office
visits with a retroactive date. While DoD acknowledges that some
providers may have provided telephonic office visits prior to the
effective date of the IFR, DoD lacks the statutory authority to make
the implementation retroactive. One commenter suggested DoD evaluate
provider and patient satisfaction and health outcomes in determining
whether to permanently adopt telephonic office visits. We agree that
this information would be valuable but ultimately determined there was
sufficient information from other sources to make a decision without
it.
3. Provisions of Final Rule
No changes were made in response to public comments; however, this
provision has been revised for the final rule (see next section for
details).
b. Interstate and International Licensing of TRICARE-Authorized
Providers
1. Provisions of the IFR
The IFR allowed providers to be reimbursed for interstate practice,
both in person and via telehealth, during the global pandemic so long
as the provider met the requirements for practicing in that State or
under Federal law. It removed the requirement that the provider must be
licensed in the state where practicing, even if that license is
optional. For providers overseas, this allowed providers, both in
person and via telehealth, to practice outside of the nation where
licensed when permitted by the host nation.
2. Analysis of Public Comments
Comments received on the relaxation of licensing requirements for
providers during the pandemic were generally supportive, with no
comments received opposed. Several commenters suggested implementing
the relaxed licensing requirement permanently for telehealth. DoD notes
that licensing remains the purview of the States and that States
generally require licensure in each State where practicing. DoD will
continue to evaluate trends in licensing requirements for telehealth
following the COVID-19 pandemic but will not be permanently adopting
this provision at this time. We note that we continue to recognize (and
recognized prior to the COVID-19 pandemic) interstate licensing
agreements and reciprocal license agreements between states where a
state considers a provider to be licensed at the full clinical practice
level based on such an agreement.
3. Provisions of Final Rule
The final rule is consistent with the IFR.
c. Waiver of Copayments and Cost-Sharing for Telehealth Services
1. Provisions of the IFR
The IFR waived cost-shares and copayments for telehealth services
for TRICARE Prime and Select beneficiaries utilizing telehealth
services with an in-network, TRICARE-authorized provider during the
President's declared national emergency for COVID-19.
2. Analysis of Public Comments
We received four comments regarding the waiving of telehealth cost-
shares and copays, all of them supportive of the waiver, with one
commenter also noting the negative effect of loss copay revenue for the
DoD. Of the comments we received, three of them encouraged the DoD to
continue to evaluate cost-sharing policies, and one comment also
encouraged the DoD to make the telehealth copay and cost-share waiver
permanent. One commenter recommended we apply the waiver of telehealth
copays to copays associated with remote physiologic monitoring (RPM).
RPM services of physiologic parameters including, but not limited to,
monitoring of weight, blood pressure, pulse oximetry and respiratory
flow rate shall be covered. RPM is considered an ancillary service and
therefore ancillary copays and cost-shares shall apply.
We thank all the commenters for their support and feedback.
TRICARE's temporary waiving of cost-shares and copays for all
telehealth services was in line with initiatives by commercial insurers
to incentivize telehealth care to help prevent the spread of COVID-19
and to reduce financial burdens on patients. TRICARE's cost-shares and
copayments are set by law and require copayments and cost-sharing for
telehealth services to be the same as if the service was provided in
person. Section 718(d) of the National Defense Authorization Act of
2017 authorized the Secretary of Defense to reduce or eliminate
copayments or cost-shares when deemed appropriate for covered
beneficiaries in connection with the receipt of telehealth services
under TRICARE. Given the national emergency caused by the COVID-19
pandemic, it was deemed appropriate to remove cost-shares and
copayments for telehealth services during the pandemic, until there was
no longer an urgent need to incentivize telehealth visits.
3. Provisions of Final Rule
The final rule is consistent with the IFR, except that this
provision may terminate early. This provision of the final rule is
being terminated early due to both the cost of waiving cost-shares and
because there remain few, if any, stay-at-home orders for this
provision to support. Defense Health Program dollars are better spent
on testing, vaccination, and treatment for COVID-19, including a waiver
of cost-shares for medically necessary COVID-19 testing, which remains
in effect as a result of the CARES Act.
B. IFR--TRICARE Coverage of Certain Medical Benefits in Response to the
COVID-19 Pandemic
This IFR was published in the FR on September 3, 2020 (85 FR
54914). Comments were accepted for 60 days until November 2, 2020. A
total of four comments were received. Two were generally supportive of
the provisions implemented in the IFR; we are grateful to the public
for their support. Please see a summary of the comments and the DoD's
responses below. Comments related to the treatment use of
investigational drugs under expanded access will be discussed in a
future final rule.
a. SNF 3-Day Prior Stay Waiver
1. Provisions of the IFR
The IFR temporarily waived the regulatory requirement that an
individual be an inpatient of a hospital for not less than three
consecutive calendar days before discharge from the hospital (three-day
prior hospital stay) for coverage of a SNF admission for the duration
of the COVID-19 public health emergency, consistent with a similar
waiver under Medicare and TRICARE's statutory requirement to have a SNF
benefit like Medicare's. The waiver will terminate when the Health and
Human Services (HHS) PHE terminates.
2. Analysis of Public Comments
We received one comment on this provision of the IFR that was
supportive of the waiver, but requested the DoD adopt another Medicare
waiver; that is, the waiver of a 60-day wellness period.
We thank the commenter for their support and feedback. TRICARE is
primary payer for Medicare/TRICARE dual eligible beneficiaries that
have exhausted the Medicare 100-day SNF benefit (meeting TRICARE
coverage requirements without any other forms of other health insurance
(OHI)), and TRICARE is also primary payer for non-Medicare TRICARE
beneficiaries who have no OHI and who meet the
[[Page 33008]]
TRICARE SNF coverage requirements. Because TRICARE covers patients
immediately after benefits are exhausted, there is no current
requirement for a 60-day wellness period under TRICARE.
3. Provisions of Final Rule
The final rule is consistent with the IFR.
b. Waiving of Acute Care Hospital Requirements for Temporary Hospital
Facilities and Freestanding ASCs
1. Provisions of the IFR
The IFR temporarily exempted temporary hospital facilities and
freestanding ASCs that enrolled as hospitals with Medicare from the
institutional provider requirements for acute care hospitals described
in paragraph 199.6(b)(4)(i). This allowed these facilities to provide
inpatient and outpatient hospital services to improve the access of
beneficiaries to medically necessary care. This change was consistent
with 10 U.S.C. 1079(i)(2) to reimburse hospitals and other
institutional providers in accordance with the same reimbursement
methodology as Medicare, when practicable. This waiver remains in
effect through the end of Medicare's ``Hospitals Without Walls''
initiative.
2. Analysis of Public Comments
No public comments were received on this provision.
3. Provisions of Final Rule
No changes were made in response to public comments; however, this
provision has been modified for the final rule (see next section for
details).
c. 20 Percent Increase in DRG Rates for COVID-19 Patients
1. Provisions of the IFR
The IFR temporarily adopted the Medicare Hospital Inpatient
Prospective Payment Add-On Payment for COVID-19 patients during the
COVID-19 PHE period. The add-on payment for COVID-19 patients increased
the weighting factor that would otherwise apply to the DRG to which the
discharge is assigned by 20 percent.
2. Analysis of Public Comments
We received one comment regarding this provision of the IFR. The
commenter noted that sole community hospitals (SCHs) are not subject to
reimbursement under the DRG system and, as such, would not be eligible
for the 20 percent increased reimbursement rate in the IFR. The
commenter requested TRICARE modify reimbursement for SCHs to make them
eligible for the 20 percent increased payment.
We appreciate the feedback from the commenter regarding a 20
percent increase for acute inpatient reimbursement for SCHs treating
COVID-19 patients. We would note that while SCHs are not eligible for
the 20 percent increased DRG reimbursement, we do an aggregate
comparison of SCH claims paid with what we would have paid under the
DRG methodology (which would include the 20 percent DRG increase) and
if the SCH payments are lower than what would have been paid under the
DRG methodology, we then pay the SCH the difference. So, while we are
not adding 20 percent to the SCH calculation, it is added to the DRG
and then used in the annual adjustment payment calculation.
3. Provisions of Final Rule
The final rule is consistent with the IFR.
d. LTCH Reimbursement at the Federal Rate
1. Provisions of the IFR
The IFR adopted the Medicare waiver of site neutral payment
provisions for LTCHs during the COVID-19 PHE period, waiving the site
neutral payment provisions and reimbursing all LTCH cases at the LTCH
PPS standard Federal rate for claims within the COVID-19 PHE period.
2. Analysis of Public Comments
No public comments were received on this provision.
3. Provisions of Final Rule
The final rule is consistent with the IFR.
e. Adoption of Medicare's NTAPs for New Medical Services
1. Provisions of the IFR
The IFR permanently added coverage of Medicare's NTAP payments for
new medical services, adding an additional payment to the DRG payment
for new and emerging technologies approved by Medicare.
2. Analysis of Public Comments
No public comments were received on this provision.
3. Provisions of Final Rule
No changes were made in response to public comments; however, this
provision has been revised in the final rule (see next section for
details).
f. Adoption of Medicare's HVBP Program
1. Provisions of the IFR
The IFR permanently added coverage of Medicare's HVBP Program. The
HVBP Program provides incentives to hospitals that show improvement in
areas of health care delivery, process improvement, and increased
patient satisfaction.
2. Analysis of Public Comments
No comments were received on this provision.
3. Provisions of Final Rule
The final rule content is consistent with the IFR content; however
the HVBP provision has been moved from 199.14(a)(1)(iii)(E)(6) to
199.14(a)(1)(iv)(B) to account for the changes to the NTAP provisions.
IV. Summary of Changes From IFRs
A. Telephonic Office Visits
Telephonic office visits temporarily adopted in the IFR are
permanently adopted in this final rule. The Director, DHA shall issue
subsequent policy guidance of medically necessary and appropriate
telephonic office visits to ensure best practices and protect against
fraud.
B. Temporary Hospitals
The final rule modifies the waiver of acute care hospital
requirements at paragraph 199.6(b)(4)(i) by expanding the waiver to
include any facility registered with Medicare under its Hospitals
Without Walls initiative, not just temporary hospitals and freestanding
ASCs as were authorized by the IFR.
C. NTAPs
This final rule permanently adopts the Medicare NTAP methodology
and future NTAP modifications published by CMS, for those otherwise
approved benefits under the TRICARE Program. This rule also creates a
pediatric NTAP reimbursement methodology based on 100 percent of the
costs in excess of the MS-DRG. Finally, this rule provides a mechanism
to establish a TRICARE-specific NTAP for those high-cost treatments
that do not have an NTAP designation because the population affected
and treated by these new technologies are outside of Medicare's
beneficiary population.
D. Adoption of Medicare's HVBP Program
This final rule moves the HVBP provision from 32 CFR
199.14(a)(1)(iii)(E)(6) to 32 CFR
[[Page 33009]]
199.14(a)(1)(iv)(B) to account for the changes to the NTAP provisions;
there are no changes to the content of the HVBP provision.
E. Telehealth Cost-Share/Copayment Waiver
This final rule finalizes the cost-share/copayment waiver provision
as written in the IFR, except that it now terminates on the effective
date of this rule, or the date of termination of the President's
national emergency for COVID-19, whichever is earlier.
V. Regulatory Analysis
A. Regulatory Planning and Review
a. Executive Orders
Executive Order 12866, ``Regulatory Planning and Review'' and Executive
Order 13563, ``Improving Regulation and Regulatory Review''
Executive Orders 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, distribute impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. Accordingly, the rule has been reviewed by the Office of
Management and Budget (OMB) under the requirements of these Executive
Orders. This rule has been designated a significant regulatory action,
although, not determined to be economically significant, under section
3(f) of Executive Order 12866.
b. Summary
The modifications to paragraph 199.4(g)(52) in this FR will revise
the regulatory exclusion prohibiting coverage of telephone services and
thereby allow permanent coverage of medical necessary and appropriate
telephonic office visits for all TRICARE beneficiaries in all
geographic locations.
The modification to paragraph 199.6(b)(4)(i) in this FR will allow
any entity that temporarily enrolled with Medicare as a hospital
through the Hospitals Without Walls initiative to be deemed to meet the
requirements for acute care hospitals established under TRICARE for the
duration of the COVID-19 pandemic. This will allow more entities to
provide inpatient and outpatient hospital services, increasing access
to medically necessary care for beneficiaries.
The modifications to paragraph 199.14(a)(1)(iv)(A) (previously
199.14(a)(1)(iii)(E)(5) in the IFR and re-designated in this final
rule) will: (1) Adopt the Medicare NTAP methodology and future NTAP
modifications published by CMS, (2) create a pediatric NTAP
reimbursement methodology based on 100 percent of the costs in excess
of the MS-DRG, and (3) provide a mechanism to reimburse high-cost
treatments that do not have a Medicare NTAP designation (due to
beneficiary population differences).
The modifications to paragraph 199.17(l)(3) in this rule will
provide for an earlier termination of the temporary waiver of cost-
sharing and copayments for telehealth.
c. Affected Population
The modifications in this rule impact all TRICARE beneficiaries,
TRICARE-authorized providers, the TRICARE program staff and
contractors. Beneficiaries will be impacted by the permanent addition
of telephonic office visits, the elimination of the telehealth cost-
share/copayment waivers, increased access to new technologies afforded
by the pediatric NTAPs reimbursement methodology, and increased access
to acute care in temporary hospitals. TRICARE-authorized providers will
be minimally impacted in that telephonic office visit will give them a
new means to provide care and treatment to beneficiaries and generate
revenue. TRICARE-authorized providers who administer Medicare approved
NTAPs to pediatric patients will be reimbursed at a higher rate. Acute
care facilities that qualify under Medicare's Hospitals Without Walls
initiative will benefit by automatically qualifying as a TRICARE-
authorized provider for the duration of the pandemic. TRICARE program
staff and contractors who administer the TRICARE benefit will be
minimally impacted as this change will require them to update their
systems to accommodate the change.
d. Costs <SUP>5</SUP>
---------------------------------------------------------------------------
\5\ Most costs associated with this final rule are technically
considered to be transfers, i.e., an income transfer between
taxpayers and program beneficiaries. The only true ``costs'' of this
rule are administrative costs, and all other costs should be
considered to be transfer payments.
---------------------------------------------------------------------------
The new incremental costs associated with this final rule are
$20.88M through FY24, not including savings resulting from early
termination of the telehealth cost-share/copayment waiver
(approximately $4.8M savings per month). For context, this section also
provides updated cost estimates for temporary benefit and reimbursement
changes implemented in prior IFRs that are finalized in this FR
($278.0M through September 30, 2022), including the telehealth cost-
share/copayment waiver being terminated by the FR (estimated cost
$149.7M through September 30, 2022), and updated cost estimates
associated with permanent reimbursement changes implemented in prior
IFRs that are finalized in this FR ($13.0M through FY24).
Administrative costs to implement all provisions are $0.67M in one-time
costs for both previously implemented provisions and modifications in
this final rule.
This estimate assumes the President's national emergency for COVID-
19 would expire by September 2022. The number and severity of COVID-19
cases for TRICARE patients, along with the length of the President's
declared national emergency for COVID-19 and the associated HHS PHE
would impact the estimates provided in this section.
1. New Incremental Costs
The incremental health care impact of new permanent benefit and
reimbursement changes implemented in the final rule is $20.88M through
FY24, and includes coverage of telephonic office visits, expanded
coverage of temporary hospitals, the reimbursement methodology for
pediatric NTAP cases, and the addition of TRICARE NTAPs. These amounts
are the only new costs associated with the FR (i.e., costs for benefits
and reimbursement changes that have not already been implemented).
Table 1--New Costs Due to Modifications in the Final Rule
------------------------------------------------------------------------
Provision Through FY2024
------------------------------------------------------------------------
Paragraph 199.4(g)(52)--Permanent Coverage of $19.6M
Telephonic Office Visits.............................
Paragraph 199.6(b)(4)(i)--Expanded Coverage for 0M
Temporary Hospitals..................................
Paragraph 199.14(a)(1)(iv)(A)(2)--Methodology for 0.04M
Pediatric NTAPs Cases................................
[[Page 33010]]
Paragraph 199.14(a)(1)(iv)(A)(3)--Addition of TRICARE 1.2M
NTAPs................................................
-----------------
Total............................................. 20.88M
------------------------------------------------------------------------
Telephonic Office Visits. Government expenditures for TRICARE
first-pay and second pay claims for identifiable telephonic office
visits amounted to approximately $7.6 million in Fiscal Year (FY) 2020
and $15.4 million in FY21. Also, the average government cost per
service for telephonic office visits was $56, which is 19 percent less
than the overall telehealth average of $81. This estimate assumes
telephonic office visits will decrease after the pandemic, as
beneficiaries become more comfortable or even prefer in-person visits.
Additionally, the elimination of the telehealth cost-share/copayment
waiver may shift some visits that could have been performed virtually
to in-person as there will no longer be a financial incentive to obtain
services virtually. After the drop in visits following the pandemic, we
assume a modest (5 percent) increase in cost for telephonic office
visits each subsequent FY. Lastly, as this provision was originally set
to expire upon the expiration of the national emergency, and this
estimate assumes that the national emergency declaration will terminate
September 30, 2022, the incremental costs of this provision include
only the costs in FY23 and FY24.
Expanded Coverage of Temporary Hospitals. This estimate assumes
that care received at facilities that register with Medicare as
hospitals would have been provided in other TRICARE-authorized
hospitals but for the regulation change. We do not anticipate any
induced demand for hospital care due to the authorization of new
facilities. As such, there are no incremental costs associated with
expanding coverage of temporary hospitals.
NTAP Pediatric Reimbursement Methodology. An analysis of claims
data for FY20 and FY21 found 23 pediatric cases which would have
qualified under this methodology. This estimate is based on an average
of what would have been paid for those cases, along with calculations
for increases in health care costs each year. This estimate includes
only the difference between the standard NTAP rate (65 percent of the
cost of treatment) and the NTAP Pediatric reimbursement rate (100
percent). This estimate is highly uncertain as the number of pediatric
patients receiving an NTAP each year will vary (we assumed 15 cases or
fewer per year), the costs of those NTAPs are unknown, and because the
number of NTAPs approved by Medicare increases each year.
TRICARE NTAP Approval Process and Reimbursement Methodology. The
costs of this provision were estimated by identifying one drug without
a Medicare NTAP due to their use by the 64 and younger population,
calculating the treatment costs for that drug, applying the TRICARE
NTAP adjustment methodology, and identifying how many TRICARE
beneficiaries were treated with that drug each year. This estimate is
highly uncertain and is dependent on the number of TRICARE NTAPs
approved each year by the Director, DHA, the cost of each of those
technologies, and the number of TRICARE beneficiaries receiving each
technology.
2. Costs Associated With Previously-Implemented Temporary Regulatory
Provisions
Provisions under this portion of the estimate have already been
implemented; cost estimates provided here are updates from estimates
published in the associated IFR under which they were implemented.
These amounts are estimated through the end of September 2022, when we
assume the President's national emergency and the HHS PHE will end. An
earlier or later termination of the national emergency or HHS PHE will
impact the estimates for this portion of the final rule.
Table 2--Costs Due to Temporary Provisions Implemented in Prior IFRs
----------------------------------------------------------------------------------------------------------------
Through
September 30,
Provision 2022 Implementation date Planned expiration
(million)
----------------------------------------------------------------------------------------------------------------
Paragraph 199.4(b)(3)(xiv)--SNF $1.9 March 1, 2020...................... Termination of
Three-Day Prior Stay Waiver. President's national
emergency for COVID-
19.
Paragraph 199.4(g)(52)--Temporary 32.1 May 12, 2020....................... Termination of
Waiver of the Exclusion on Audio- President's national
only Telehealth. emergency for COVID-
19.
Paragraph 199.6(b)(4)(i)--Temporary 0 September 3, 2020.................. Expiration of
Hospitals and Freestanding ASCs Medicare's Hospitals
Registering as Hospitals (as Without Walls
implemented in the IFR). Initiative.
Paragraph 199.6(c)(2) Waiver of 0 May 12, 2020....................... Termination of
provider licensing requirements President's national
for interstate and international emergency for COVID-
practice. 19.
Paragraph 199.14(a)(1)(iii)(E)(2)-- 76.5 January 27, 2020................... Termination HHS PHE.
20 Percent DRG Increase for COVID-
19 Patients.
Paragraph 199.14(a)(9)--LTCH Site 17.8 January 27, 2020................... Termination HHS PHE.
Neutral Payments.
Paragraph 199.17(l)(3) Temporary 149.7 May 12, 2020....................... Effective date of this
Telehealth Cost-Share/Copayment final rule or
Waiver. termination of
President's national
emergency for COVID-
19, whichever is
earlier.
----------------------------------------------------------------------------
Total.......................... 278.0 ................................... ......................
----------------------------------------------------------------------------------------------------------------
[[Page 33011]]
SNF Three-Day Prior Stay Waiver. The nominal cost associated with
this provision is due to an assumption that, as a result of the waiver,
SNF admissions will increase by three percent. This estimate is
consistent with the estimate in the IFR.
Temporary Waiver of the Exclusion of Audio-only Telehealth Visits.
This estimate accounts for amounts related to the temporary waiver of
the exclusion of audio-only telehealth visits from the first IFR, and
is consistent with the factors discussed above for telephonic office
visits. Included are amounts for FY20 through the end of FY22. These
amounts reflect the costs had the ASD(HA) not made telephonic office
visits permanent, but continued to let them expire at the end of the
national emergency. If the President's national emergency expires prior
to the end of September 2022, these amounts will shift to the above
permanent coverage of telephonic office visits.
Temporary Hospitals and Freestanding ASCs. This zero cost estimate
assumes that inpatient care provided in these alternate sites is care
that would have been reimbursed under TRICARE but for a lack of acute
care hospital facility space (i.e., we do not estimate that there would
be any induced demand because of an increase in facilities).
Additionally, it assumes that while reimbursement for outpatient
procedures in freestanding ASCs would be higher than had those
procedures been reimbursed under the traditional reimbursement rates
for freestanding ASCs, the number of facilities choosing to register as
hospitals is likely to be small enough to have a negligible impact on
the budget. This estimate is consistent with the estimate in the IFR.
Waiver of Interstate and International Licensing for Providers. The
zero cost estimate assumes patients who are seeing providers under
relaxed licensing requirements would have either seen a different
provider or the same provider in a different setting (i.e., in-person
as opposed to via telehealth) were it not for the waiver. This estimate
is consistent with the estimate in the IFR.
20 Percent DRG Increase. In the second IFR, we estimated that in an
eighteen-month period, we would spend $37.1M to 51.4M on the 20 percent
DRG increase. Actual spending through the end of FY21 was $41.5M,
consistent with and on the low end of that estimate. This is primarily
due to a lower average hospitalization cost for COVID-19 patients. This
estimate extends actual costs through the end of September 30, 2022.
Additional costs would be incurred beyond that date if the HHS PHE
continues to be in effect. This estimate is consistent with the lower
end of the estimate in the IFR.
LTCH Site Neutral Payments. TRICARE is in the process of phasing in
Medicare's site-neutral payment rates. The phase-in has been halted as
a result of the IFR; this estimate assumes TRICARE LTCH claims will be
paid at the full LTCH PPS rate through the end of the HHS PHE. This
estimate is consistent with the estimate in the IFR.
Temporary Waiver of Cost-Shares and Copayments for Telehealth
Services. The largest cost-driver for provisions in the previously
published IFRs is the temporary waiver of cost-shares and copayments
for telehealth, which is expected to cost $149.7M from implementation
on May 12, 2020, through September 30, 2022. These costs are associated
with the benefit as implemented in the previous IFR; because we are
terminating the benefit early in the final rule, we expect to realize a
cost savings of approximately $4.8M per month prior to the end of the
President's national emergency for COVID-19. The IFR only estimated a
9-month cost ($66M). The estimate in this IFR is largely consistent
with the original estimate (approximately $7.3M per month), with an
expected decrease in per-month spend further from the initial days of
the pandemic and the stay-at-home orders that prompted this provision.
3. Costs Associated With Previously-Implemented Permanent Regulatory
Provisions
The second COVID-19 IFR implemented two permanent provisions, NTAPs
and HVBP. Both are finalized in this FR. The costs associated with the
changes to NTAPs implemented in this FR are provided in the first
section of the cost estimate. This section provides costs associated
with NTAPs as implemented in the IFR, as well as costs associated with
the HVBP Program.
Table 3--Costs Due to Permanent Reimbursement Changes Implemented in the
Second IFR
------------------------------------------------------------------------
Provision Through FY2024
------------------------------------------------------------------------
Paragraph 199.14(a)(1)(iv)(A)--NTAPs (not including $9.1M
the new pediatric reimbursement methodology provided
in table 1)..........................................
Paragraph 199.14(a)(1)(iv)(B)--HVBP Program........... 3.9M
-----------------
Total............................................. 13.0M
------------------------------------------------------------------------
NTAPs. The IFR included the cost estimate through September 30,
2021 (a range of $5.7M to $11.6M), while this estimate provides an
updated five-year costing using actual TRICARE claims data for
utilization and reimbursement of NTAPS. In creating this estimate, we
identified TRICARE claims containing a treatment with a Medicare NTAP
in either FY2020 or FY2021 and identified the total estimated add-on
payment amounts and the total estimated Medicare cases each year, as
published in the Federal Register. In FY2020, there were 18 treatments
with NTAPs and 78 TRICARE claims containing one of these treatments; in
FY2021, there were 23 NTAP treatments and 145 TRICARE claims with
NTAPs, although the average NTAP maximum add-on amount decreased
dramatically from FY2020 to FY2021 due to the average costs of the
respective treatments.
For FY2022, there are a total of 38 Medicare treatments with NTAPs,
15 of which are new and represent a new traditional technology,
Qualified Infectious Disease Products, or breakthrough technology.
Consistent with the IFR, this estimate assumes TRICARE NTAPs would
continue to be a similar percentage of inpatient spending to Medicare's
NTAP usage and that TRICARE would adopt all of Medicare's NTAPs. This
amount will vary depending on the number of new NTAPs adopted by
Medicare each year, the extent to which Medicare-identified emerging
technologies are covered under TRICARE's statutory and regulatory
requirements, and the extent to which TRICARE's population utilizes
these technologies. The costs for this provision may overestimate the
incremental costs of this regulatory change, because many of these
claims were being approved on a case-by-case basis by the Director,
DHA, under waiver authority. In those cases, adopting NTAPs was likely
to reflect a cost savings compared to the estimated costs, as waivers
are typically paid at billed charges.
[[Page 33012]]
HVBP Program. The HVBP Program was implemented retroactive to
January 1, 2020; we anticipated that those hospitals qualifying for a
positive adjustment for prior claims would do so, while those with
negative adjustments or adjustments close to zero dollars would not.
This would result in a cost in the first year, with claims in following
years assumed to be budget neutral. This cost estimate is higher than
the cost estimate published in the IFR ($2.5M), as there was more real-
world data available to us on hospitals eligible for a positive
adjustment for the initial implementation year.
e. Benefits
The addition of telephonic office visits as a permanent benefit
will positively impact beneficiaries, particularly beneficiaries with
limited access to broadband and other technology required for video
telehealth visits, as this change will provide them better access to
the existing telehealth benefit. This will result in avoided travel
time and time spent in the provider's waiting room (a benefit of
approximately one hour per beneficiary per visit, at a monetized value
to the beneficiary of $20.00 per hour). Providers will benefit from
telephonic office visits by being able to better treat their patients,
particularly patients who might not come into the office for regular
office visits. The implementation of a distinct pediatric reimbursement
methodology for pediatric NTAPs will positively impact beneficiaries
and providers, as providers will be able to offer beneficiaries access
to new treatments knowing full reimbursement will be provided.
Expansion of coverage of temporary hospitals will benefit
beneficiaries, who will have access to more acute care facilities
during the pandemic.
f. Alternatives
DoD considered several alternatives to this rulemaking. The first
option considered not publishing a final rule or publishing a final
rule finalizing the IFR provisions listed without any changes. The
temporary changes would have expired as planned without modification.
Under this option: Telephonic office visits would not have become a
permanent benefit, the coverage of hospitals under Medicare's Hospitals
Without Walls initiative benefit would have remained as published in
the IFR (meaning facilities other than temporary hospitals and
freestanding ambulatory surgical centers, such as freestanding
emergency rooms, would have continued to be ineligible for temporary
status as an acute care facility), a new pediatric reimbursement
methodology for NTAPs would not have been implemented, and the
temporary waiver of telehealth cost-shares and copayments would not
have been potentially terminated early (at a potential cost of around
$4.8M per month). Each of the modifications in this final rule
addresses a concern or further develops the benefit based on
information we have gathered since the IFRs were published. This option
was determined to be insufficient to meet the needs of the TRICARE
Program.
DoD also considered publishing this final rule as is, but
restricting telephonic office visits to only those TRICARE
beneficiaries without access to conventional two-way audio-video
equipment. We determined such a restriction would be impractical,
unnecessary, and difficult and costly to administer. This option would
have been inconsistent with modern practices in the health care field
and would have placed an unnecessary burden on providers and
beneficiaries. This option was not selected because its benefits did
not outweigh the administrative burden on DHA, providers, and the
potential cost of reduced access on beneficiaries.
Public Law 96-354, ``Regulatory Flexibility Act'' (5 U.S.C. 601)
The Assistant Secretary of Defense for Health Affairs certifies
that this final rule is not subject to the Regulatory Flexibility Act
(5 U.S.C. 601) because it would not, if promulgated, have a significant
economic impact on a substantial number of small entities. Therefore,
the Regulatory Flexibility Act, as amended, does not require us to
prepare a regulatory flexibility analysis.
DoD anticipates that permanent coverage of telephonic office visits
will impact approximately 133,000 individual professional providers.
The provisions impacting inpatient facilities (the 20 percent DRG
increase for COVID-19 patients, NTAPs, and the HVBP Program) will
impact between 3,400 and 3,800 hospitals. The number of LTCHs impacted
by site neutral payments will be between 200 and 300. 1,300 SNFs will
be impacted by the three-day prior hospital stay waiver. We are unable
to estimate the number of providers impacted by the interstate and
international licensing waiver, but expect it will be fairly small as a
percentage of total TRICARE providers. We are similarly unable to
estimate how many facilities will be eligible as TRICARE-authorized
acute care facilities by registering with Medicare's Hospitals Without
Walls initiative who would not have been otherwise eligible under
TRICARE, but expect this to be a small number as well.
The provisions of this IFR that are most likely to have an economic
impact on hospitals and other health care providers are the
reimbursement provisions adopted to meet the statutory requirement that
TRICARE reimburse like Medicare. As its measure of significant economic
impact on a substantial number of small entities, HHS uses an adverse
change in revenue of more than 3 to 5 percent. While TRICARE is not
required to follow this guidance in the issuance of our rules, we
provide this metric for context, given that these temporary and
permanent changes align with similar changes made by Medicare.
Given that the temporary reimbursement provisions of this IFR
increase reimbursement for hospitals and LTCHs, we find that these
provisions would not have an adverse impact on revenue for hospitals
and, therefore, would not have a significant impact on these hospitals
and other providers meeting the definition of small businesses. We also
find that NTAPs, given that they increase revenue under the DRG system,
would not have an adverse impact on hospitals and providers. The HVBP
program would not reduce revenue for a hospital being penalized under
the system beyond the HHS threshold. Lastly, coverage of telephonic
office visits and temporary hospitals are not expected to result in any
adverse economic impact on hospitals or other health care providers.
C. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated this rule
as not a major rule, as defined by 5 U.S.C. 804(2).
D. Sec. 202, Public Law 104-4, ``Unfunded Mandates Reform Act''
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2
U.S.C. 1532) requires agencies to assess anticipated costs and benefits
before issuing any rule whose mandates require spending in any 1 year
of $100 million in 1995 dollars, updated annually for inflation. This
final rule will not mandate any requirements for State, local, or
tribal governments, nor will it affect private sector costs.
E. Public Law 96-511, ``Paperwork Reduction Act'' (44 U.S.C. Chapter
35)
It has been determined that 32 CFR part 199 does not impose
reporting or recordkeeping requirements under the Paperwork Reduction
Act of 1995.
[[Page 33013]]
F. Executive Order 13132, ``Federalism''
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. This final rule will not have a substantial effect on
State and local governments.
G. Executive Order 13175, ``Consultation and Coordination With Indian
Tribal Governments''
It has been determined that this rule does not have a substantial
effect on Indian tribal governments. This rule does not impose
substantial direct compliance costs on one or more Indian tribes,
preempt tribal law, or effect the distribution of power and
responsibilities between the federal government and Indian tribes.
List of Subjects in 32 CFR Part 199
Administrative practice and procedure, Claims, Dental, Fraud,
Health care, Health insurance, Individuals with disabilities, Mental
health programs, and Military personnel.
For the reasons stated in the preamble, the interim final rules
amending 32 CFR part 199, which were published at 85 FR 27921-27927,
May 12, 2020, and 85 FR 54914-54924, September 3, 2020, are adopted as
final with changes, except for the note to paragraph
199.4(g)(15)(i)(A), published at 85 FR 54923, September 3, 2020, which
remains interim, and DoD further amends 32 CFR part 199 as follows:
PART 199--CIVILIAN HEALTH AND MEDICAL PROGRAM OF THE UNIFORMED
SERVICES (CHAMPUS)
0
1. The authority citation for part 199 continues to read as follows:
Authority: 5 U.S.C. 301; 10 U.S.C. chapter 55.
0
2. Amend Sec. 199.2 by adding definitions for ``Biotelemetry,''
``Telephonic consultations'' and ``Telephonic office visits'' in
alphabetical order to read as follows:
Sec. 199.2 Definitions.
* * * * *
Biotelemetry. A diagnostic or monitoring procedure for the
detection or measurement of human physiologic functions from a distance
using a biotelemetry device to remotely monitor various vital signs of
ambulatory patients. Biotelemetry may also be referred to as remote
physiologic monitoring of physiologic parameters. See Sec. 199.4.
* * * * *
Telephonic consultations: A covered consultation service conducted
via telephone call between TRICARE-authorized providers, including a
verbal and written report to the patient's treating/requesting
physician or other TRICARE-authorized provider.
Telephonic office visits. A covered service provided via a
telephone call between a beneficiary who is an established patient and
a TRICARE-authorized provider. See Sec. 199.4.
* * * * *
0
3. Amend Sec. 199.4 by revising paragraphs (c)(1)(iii), (g)(52)
introductory text and (g)(52)(i) to read as follows:
Sec. 199.4 Basic program benefits.
* * * * *
(c) * * *
(1) * * *
(iii) Telehealth services. Health care services covered by TRICARE
and provided through the use of telehealth modalities including
telephone services for: telephonic office visits; telephonic
consultations; electronic transmission of data or biotelemetry or
remote physiologic monitoring services and supplies, are covered
services to the same extent as if provided in person at the location of
the patient if those services are medically necessary and appropriate
for such modalities. The Director will establish special procedures for
payment for such services. Additionally, where appropriate, in order to
incentive the use of telehealth services, the Director may modify the
otherwise applicable beneficiary cost-sharing requirements in paragraph
(f) of this section which otherwise apply.
* * * * *
(g)(52) Telephone services. Services or advice rendered by
telephone are excluded. Exceptions:
(i) Medically necessary and appropriate Telephonic office visits
are covered as authorized in paragraph (c)(1)(iii) of this section.
* * * * *
0
4. Effective June 1, 2022 amend Sec. 199.6 by revising the note to
paragraph (b)(4)(i)(I) to read as follows:
Sec. 199.6 TRICARE-authorized providers.
* * * * *
(b) * * *
(4) * * *
(i) * * *
(I) * * *
Note to paragraph (b)(4)(i)(I): For the duration of Medicare's
``Hospitals Without Walls'' initiative for the coronavirus disease
2019 (COVID-19) outbreak, any entity that temporarily enrolls with
Medicare as a hospital may be temporarily exempt from certain
institutional requirements for acute care hospitals under TRICARE.
To the extent practicable, the Director, Defense Health Agency
(DHA), will adopt by administrative policy any process requirement
related to Medicare's Hospitals Without Walls initiative.
* * * * *
0
5. Amend Sec. 199.14 by:
0
a. Adding a sentence at the end of paragraph (a)(1)(iii)(E)
introductory text;
0
b. Adding paragraph (a)(1)(iv);
0
c. Redesignating paragraph (a)(1)(iii)(E)(5) as paragraph (a)(1)(iv)(A)
and revising newly redesignated paragraph (a)(1)(iv)(A);
0
d. Redesignating paragraph (a)(1)(iii)(E)(6) as paragraph
(a)(1)(iv)(B).
The revision and addition read as follows:
Sec. 199.14 Provider reimbursement methods.
(a) * * *
(1) * * *
(iii) * * *
(E) *** Additional adjustments to DRG amounts are included in
paragraph (a)(1)(iv) of this section.
* * * * *
(iv) Special Programs and Incentive Payments. (A) Additional
payment for new medical services and technologies. TRICARE will make
New Technology Add On Payments (NTAPs) adjustments to DRGs as provided
in paragraphs (a)(1)(iv)(A)(1) through (a)(1)(iv)(A)(11) of this
section. The Director, Defense Health Agency (DHA), shall provide
notice of the issuance of policies and guidelines adopting such
adjustments together with any variations deemed necessary to address
unique issues involving the beneficiary population or program
administration.
(1) Adoption of Medicare NTAPs. For TRICARE covered services and
supplies, TRICARE will adopt Medicare NTAPs as implemented under 42 CFR
412.87 under the same conditions as published by the Centers for
Medicare & Medicaid Services, except for pediatric cases.
(2) Pediatric cases. For pediatric NTAP DRGs, the TRICARE NTAP
adjustment shall be modified to be set at 100 percent of the costs in
excess of the Medicare Severity-Diagnosis Related Group (MS-DRG)
payment. As used in this paragraph, pediatric is defined as services
and supplies provided to individuals under the age of 18, or who are
being treated in a children's hospital or in a pediatric ward.
[[Page 33014]]
(3) TRICARE designated NTAP adjustments. For categories of TRICARE
covered services and supplies for which Medicare has not established an
NTAP adjustment for DRGs, the Director, DHA may designate a TRICARE
NTAP adjustment through a process using criteria to identify and select
such new technology services/supplies similar to that utilized by
Medicare under 42 CFR 412.87. The Director, DHA may then designate a
TRICARE NTAP reimbursement adjustment through a process using a
methodology similar to the Medicare methodology outlined in 42 CFR
412.88. This discretionary authority to designate TRICARE NTAP
adjustments shall apply to services and supplies typically provided to
TRICARE beneficiaries age 64 or younger when Medicare has not
established an NTAP adjustment for such services/supplies. As with
other discretionary authority under this part, a decision to designate
a TRICARE category of services/supplies for an NTAP adjustment to DRGs
and the amount of such an adjustment are not subject to the appeal and
hearing procedures of Sec. 199.10. The Director, DHA, shall select
which new technologies may be designated as TRICARE NTAPs and will
publish this list based on the eligibility criteria and reimbursement
methodology provided in paragraphs (a)(1)(iv)(A)(4) through
(a)(1)(iv)(A)(11) of this section.
(4) Eligibility requirements and reimbursement methodology for
TRICARE designated NTAP adjustments. A new medical service or
technology represents an advance that substantially improves, relative
to technologies previously available, the diagnosis or treatment of
TRICARE beneficiaries. The totality of the circumstances is considered
when making a determination that a new medical service or technology
represents an advance that substantially improves, relative to services
or technologies previously available, the diagnosis or treatment of
TRICARE beneficiaries.
(5) Criteria for improvement. A determination that a new medical
service or technology represents an advance that substantially
improves, relative to services or technologies previously available,
the diagnosis or treatment of TRICARE beneficiaries means one or more
of the following:
(i) The new medical service or technology offers a treatment option
for a patient population unresponsive to, or ineligible for, currently
available treatments.
(ii) The new medical service or technology offers the ability to
diagnose a medical condition in a patient population where that medical
condition is currently undetectable, or offers the ability to diagnose
a medical condition earlier in a patient population than allowed by
currently available methods and there must also be evidence that use of
the new medical service or technology to make a diagnosis affects the
management of the patient.
(iii) The use of the new medical service or technology
significantly improves clinical outcomes relative to services or
technologies previously available as demonstrated by one or more of the
following seven outcomes: A reduction in at least one clinically
significant adverse event, including a reduction in mortality or a
clinically significant complication; A decreased rate of at least one
subsequent diagnostic or therapeutic intervention; A decreased number
of future hospitalizations or physician visits; A more rapid beneficial
resolution of the disease process treatment including, but not limited
to, a reduced length of stay or recovery time; An improvement in one or
more activities of daily living; An improved quality of life; or A
demonstrated greater medication adherence or compliance.
(iv) The totality of the information otherwise demonstrates that
the new medical service or technology substantially improves, relative
to technologies previously available, the diagnosis or treatment of
TRICARE beneficiaries.
(6) Evidence. Evidence from scientific literature may be sufficient
to establish that a new medical service or technology represents an
advance that substantially improves, relative to services or
technologies previously available, the diagnosis or treatment of
TRICARE beneficiaries.
(7) Prevalence. The medical condition diagnosed or treated by the
new medical service or technology may have a low prevalence among
TRICARE beneficiaries.
(8) Subpopulation. The new medical service or technology may
represent an advance that substantially improves, relative to services
or technologies previously available, the diagnosis or treatment of a
subpopulation of patients with the medical condition diagnosed or
treated by the new medical service or technology.
(9) Newness criteria. A medical service or technology may be
considered new within 2 or 3 years after the point at which data begin
to become available reflecting the inpatient hospital code assigned to
the new service or technology (depending on when a new code is assigned
and data on the new service or technology becomes available for DRG
recalibration). After TRICARE has recalibrated the DRGs, based on
available data, to reflect the costs of an otherwise new medical
service or technology, the medical service or technology will no longer
be considered ``new'' under the criterion of this section.
(10) Payment methodology. For discharges involving new medical
services or technologies that meet the criteria specified in paragraphs
(a)(1)(iv)(A)(4) through (a)(1)(iv)(A)(9) and that are approved as
TRICARE NTAPs per paragraph (a)(1)(iv)(A)(11) of this section, TRICARE
payment will be the lesser of:
(i) The CMS designated percentage of the estimated costs of the new
technology or medical service, as published in 42 CFR 412.88; or
(ii) The CMS designated percentage of the difference between the
full DRG payment and the hospital's estimated cost for the case, as
published in 42 CFR 412.88.
(11) Publication and timing. TRICARE may consider whether a new
medical service or technology meets the eligibility criteria specified
in paragraphs (a)(1)(iv)(A)(4) through (a)(1)(iv)(A)(9) of this section
and announce the results on the NTAP website. In doing so, TRICARE only
considers, for add-on payments for a particular fiscal year, an
application for which the new medical device or product has received
FDA marketing authorization by July 1 prior to the particular fiscal
year; or the application is submitted under an alternative pathway to
the FDA for which conditional NTAP approval for FDA marketing
authorization is granted before July 1 of the fiscal year for which the
applicant applied for new technology add-on payments.
* * * * *
0
6. Amend Sec. 199.17 by adding a second sentence at the end of
paragraph (l)(3)(iii) to read as follows:
Sec. 199.17 TRICARE program.
* * * * *
(l) * * *
(3) * * *
(iii) * * * This temporary waiver provision terminates July 1, 2022
or the date of termination of the President's declared national
emergency for COVID-19, whichever is earlier.
* * * * *
[[Page 33015]]
Dated: May 12, 2022.
Aaron T. Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2022-10545 Filed 5-31-22; 8:45 am]
BILLING CODE 5001-06-P
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