2.0 POLICY
The Assistant Secretary of
Defense (Health Affairs) (ASD(HA)) issued an Interim Final Rule
(IFR) with comment in the Federal Register on May 12,
2020, temporarily amending the TRICARE regulation to encourage social
distancing and prevent the spread of COVID-19 by incentivizing the
use of telemedicine services.
The ASD(HA) issued a second
IFR with comment in the Federal Register on September
3, 2020, temporarily amending the TRICARE regulation to expand the
COVID-19 therapies available to TRICARE beneficiaries while doing
so in settings that ensure informed consent of the beneficiary,
and that the benefits of treatment outweigh the potential risks.
This IFR also expands TRICARE coverage of acute care facilities
during the COVID-19 pandemic.
The ASD(HA) issued a third
IFR with comment in the
Federal Register on October
30, 2020, temporarily amending the TRICARE regulation to cover National
Institute of Allergy and Infectious Disease-sponsored clinical trials
when for the treatment or prevention of COVID-19. See
Chapter 7, Section 24.2.
The ASD(HA) issued
a Final Rule in the Federal Register on
June 1, 2022, finalizing certain temporary provisions of the IFRs
published in 2020 in response to the COVID-19 pandemic. The Final Rule
finalized without change the temporary relaxation of state professional
licensing requirements (see paragraph 2.2).
The Final Rule finalized coverage of temporary hospitals, with modifications
(see paragraph 2.4). The Final Rule
made permanent coverage of audio-only telephone services (renamed telephonic
office visits) (see Chapter 7, Section 22.1).
2.1 Temporary
Coverage of Audio-Only Telephone Services
Existing regulations exclude
TRICARE coverage of telephone services (audio-only) except for biotelemetry.
Given the CDC guidelines for social distancing and some states governors’
orders for residents to stay at home, the ASD(HA)
is permitting an exception to the regulatory exclusion. TRICARE-authorized
providers are allowed to render medically necessary care and treatment
to beneficiaries over the telephone, when face-to-face, hands-on
treatment is not medically necessary.
2.1.1 Telephone
services (audio-only) are not excluded when otherwise covered TRICARE services
are provided to a beneficiary through this modality, if the services
are medically or psychologically necessary and appropriate.
2.1.2 Telephone
services involving evaluation and management visits shall be reported
utilizing Current Procedural Terminology (CPT) code 99441-3; 98966-8;
Healthcare Common Procedure Coding System (HCPCS) code G2012.
2.1.3 Other
authorized telephone services (e.g., psychotherapy services) shall
be reported with the appropriate CPT or HCPCS code and with the
appropriate modifier or place of service code (e.g., 02) to report
that the care was delivered via telephone. Place of Service Code
02 is not required for telehealth claims if a more appropriate Place
of Service Code is necessary for correct billing.
2.1.4 Audio-only
care is inappropriate where a visual connection would be required
to ensure appropriate medical care; e.g., evaluation of a skin lesion
by a dermatologist or intensive outpatient programs.
2.2 Temporary Relaxation of State
Professional Licensing Requirements
2.2.1 In
the United States, if applicable federal or state law permits providers
to operate within a jurisdiction without obtaining a license in
that state, the contractor may cost-share services
provided to beneficiaries by an otherwise authorized TRICARE provider if
that provider holds an equivalent license from any state in the
United States, complies with provisions for interstate practice
in the state where the beneficiary is receiving care, and is not
affirmatively barred or restricted from practicing in any state in
the United States. This temporary change does not supplant state
authority to regulate licensure, but assures that if licensure requirements
are relaxed by any state or the federal government during the period
of the COVID-19 pandemic, that providers caring for TRICARE beneficiaries
in compliance with applicable state or federal law will be eligible
for reimbursement under TRICARE.
2.2.2 For overseas
locations, if the host-nation permits providers to operate within
that nation without obtaining a license in that nation, the
TRICARE Overseas Program (TOP) contractor may cost-share services
provided to beneficiaries by a TRICARE-authorized provider if
the provider holds an equivalent license in the nation in which
they normally practice and meets all requirements for practice under
the host nation.
2.2.3 Providers listed on the Department
of Health and Human Services (HHS) sanction list remain ineligible
to provide care under TRICARE.
2.3 Coverage of Treatment Use of
Investigational Drugs Under Expanded Access
2.3.1 The
contractor shall cost-share treatment use of investigational
drugs under expanded access
under the
medical program under the following circumstances:
2.3.1.1 The investigational drug is
for the treatment of a serious or life-threatening case of COVID-19
or its associated sequelae.
2.3.1.2 The United States Food and
Drug Administration (FDA) has approved the investigational drug
for treatment use under expanded access.
2.3.1.3 The investigational drug is
administered in a setting approved by the FDA (i.e., individual patient
access, emergency individual patient access, intermediate access,
and widespread access).
2.3.2 For
care provided overseas,
the TOP contractor shall cost-share drugs
without formal marketing approval in a nation
when
the following conditions
in that nation are
met:
2.3.2.1 Use of the investigational
drug is permitted in that nation.
2.3.2.2 The investigational drug is
intended to treat a serious or life-threatening case of COVID-19 or
its associated sequelae.
2.3.2.3 There is no satisfactory or
comparable alternative available.
2.3.2.4 The potential patient benefit
justifies the potential risks of treatment use.
2.3.2.5 Providing
the investigational drug will not compromise the potential development
or interfere with clinical investigations that could support marketing
approval of the investigational drug for the use.
2.3.3 The
contractor shall not cost-share investigational drugs when
provided as part of a clinical trial.
2.3.4 Coverage of investigational
drugs in this section supersedes the exclusion of treatment investigational
new drugs under
Chapter 8, Section 9.1.
2.3.5 Coverage of investigational
drugs in this section does not apply to drugs administered under
the TRICARE Pharmacy program.
2.4 Temporary Hospital Expansion
Sites
2.4.1 Temporary
hospitals
, freestanding Ambulatory
Surgical Centers (ASCs)
, and other entities that
enroll with Medicare as hospitals for the duration of Medicare’s
“Hospitals without Walls” initiative are exempt from
certain institutional
requirements for acute care hospitals listed in
32 CFR 199.6(b)(4)(i). The contractor shall
temporarily change the status of these providers to a hospital status when
the provisions of this
paragraph 2.4, are met.
2.4.2 The
contractor shall ensure temporary hospitals, including
temporary hospital expansion locations such as the patient’s home,
meet
the following requirements:
2.4.2.1 Centers for Medicare
and Medicaid Services (CMS) has approved the
location or site to receive payment for Medicare services.
2.4.2.2 The location or site meets all
criteria required by CMS for Medicare coverage of inpatient or outpatient
hospital services.
2.4.3 The
contractor shall ensure freestanding ASCs
meet
the following requirements:
2.4.3.1 Enrollment with and approval
by CMS as a hospital. The contractor shall obtain a copy of the
facility’s approval letter before reimbursing services and supplies.
2.4.3.2 If
a freestanding ASC temporarily enrolls
as a hospital, but later changes or loses its enrollment
status with Medicare, then the
contractor shall no longer reimburse that
ASC as a hospital, effective on the
date of the enrollment status change under Medicare.
2.4.4 Other
entities (not including temporary hospitals and freestanding ASCs)
shall meet the following requirements:2.4.4.1 Enrollment
with and approval by CMS as a hospital. The contractor shall obtain
a copy of the facility’s approval letter before reimbursing services
and supplies.
2.4.4.2 If an entity
other than a temporary hospital or freestanding ASC temporarily
enrolls as a hospital, but later changes or loses its hospital enrollment
status with Medicare, then the contractor shall no longer reimburse
that entity as a hospital, effective on the date of the enrollment
status change under Medicare.
2.4.5 The
contractor shall ensure that services and supplies provided in these
facilities are otherwise covered under the TRICARE program.
2.4.6 The
contractor shall reimburse otherwise covered services and supplies
(provided in facilities that meet the requirements in
paragraph 2.4)
using the existing applicable TRICARE reimbursement methodologies
for hospitals.
2.5 Temporary
Waiver of Certain Critical Access Hospital (CAH) Participation Requirements
Under
32 CFR 199.6(b)(4)(xvi), CAHs must meet all
conditions of participation under 42 CFR 485.601 through 485.645
in relation to TRICARE beneficiaries in order to receive payment
under the TRICARE program. If Medicare temporarily waives a condition
of participation for CAHs, TRICARE has the legal authority to continue
to authorize the CAH as a TRICARE provider as long as Medicare does not
revoke the CAH’s status as a Medicare provider. TRICARE has exercised
this legal authority to recognize Medicare’s emergency waiver issued
under Section 1135(b) of the Social Security Act (42 United States
Code (USC) § 1320b-5), for the following requirements for CAH participation:
• The requirement that CAHs make
available 24-hour emergency care services and provide not more than
25 beds for acute (hospital-level) inpatient care or swing beds used
for Skilled Nursing Facility-Level care.
• The requirement that CAHs maintain
a length-of-stay, as determined on an annual average basis, of no
longer than 96 hours.
2.6 Temporary Waiver of Certain
Hospice Participation Requirements
Under
32 CFR 199.6(b)(4)(xiii), Hospice programs
must be Medicare approved and meet all Medicare conditions of participation
(42 CFR part 418) in relation to TRICARE patients in order to receive
payment under the TRICARE program. A hospice program may be found
to be out of compliance with a particular Medicare condition of
participation and still participate in the TRICARE program as long
as the hospice is allowed continued participation in Medicare. TRICARE
has exercised this legal authority to recognize Medicare’s emergency
waiver issued under Section 1135(b) of the Social Security Act (42
USC § 1320b-5), for the following requirements for Hospice participation:
• The requirement to provide
non-core services such as Physical Therapy (PT), Occupational Therapy
(OT), and Speech-Language Pathology (SLP).
• The requirement to conduct
on-site nurse visits every two weeks.
2.7 Temporary Waiver of the Referral
Requirement for TRICARE Prime Enrollees, Not Including Active Duty
Service Members (ADSMs), So They May Receive COVID-19 Vaccines From
Any TRICARE Authorized Non-Network Provider Without Incurring Point-of-Service
(POS) Charges Where Applicable
2.7.1 Due to
the widespread need for COVID-19 vaccines and the possibility that
one day these vaccines may not be free-of-charge, on February 23,
2021, a notice was published in the Federal Register (86 FR 10942)
advising TRICARE Prime enrollees, not including ADSMs, of a waiver
to the referral requirement so they may receive COVID-19 vaccines,
a clinical preventive service, from any TRICARE Basic (medical)
program authorized non-network provider without incurring POS charges where
applicable.
2.7.2 Although
there is no separate copayment/cost-share for clinical preventive
services, there may be a copayment/cost-share or POS charge if the
vaccine is administered as part of a primary or specialty care visit
for a reason other than preventive care or for other services received
during the office visit.
2.7.4 This waiver
does not apply to ADSMs as they are governed by the requirements
of the Supplemental Health Care Program (SHCP) which allows for
payment of claims for civilian services rendered pursuant to a referral
by a provider in a Market/Military Treatment Facility (MTF) as well
as for civilian health care. For information on the SHCP, see the
TRICARE Operations Manual (TOM),
Chapter 17.
3.0 EFFECTIVE
DATES
3.1 May 12, 2020, for
temporary exception to the prohibition on telephone services in
the United States.
3.2 May 12, 2020, for
the provision relaxing professional licensing requirements to allow
interstate and international licensing.
3.3 September
3, 2020, for treatment use of investigational drugs under expanded
access.
3.4 September
3, 2020, for temporary hospitals and freestanding ASCs enrolled
with Medicare as Hospitals.
3.5 June
1, 2022, for other entities (not including temporary hospitals and
freestanding ASCs) enrolled with Medicare as hospitals.
3.6 For overseas, the effective
date is March 10, 2020, for the provisions
identified above.
3.7 March 1, 2020, for the temporary
waiver of the CAH participation requirements.
3.8 March 1, 2020, for the temporary
waiver of the Hospice participation requirements.
3.9 December 13, 2020, for the
temporary waiver of the TRICARE Prime
referral requirement for COVID-19 vaccines.
4.0 EXPIRATION
4.1 Unless
otherwise specified in this section, for services provided in the
United States, these provisions expire upon expiration of the President’s
national emergency for the COVID-19 outbreak.
4.2 Unless
otherwise specified in this section, for services provided outside
the 50 United States, District of Columbia, and U.S. Territories
including the Commonwealth of Puerto Rico, the Virgin Islands, Guam,
American Samoa, and the Commonwealth of the Northern Mariana Islands,
these provisions expire upon conclusion of the COVID-19 pandemic,
as determined by the ASD(HA).
4.3 Coverage
of temporary hospitals, freestanding
ASCs, and other entities enrolled with
Medicare as hospitals expires upon expiration of Medicare’s “Hospitals
without Walls” initiative.
4.4 Under
section 319 of the Public Health Service (PHS) Act, a Public Health
Emergency (PHE) declaration lasts until the Secretary of HHS declares
the PHE no longer exists, or upon the expiration of the 90-day period
beginning on the date the Secretary declared a PHE exists, whichever
occurs first. The Secretary may extend the PHE declaration for subsequent
90-day periods for as long as the PHE continues to exist, and may
terminate the declaration whenever he determines the PHE has ceased
to exist. The manual provisions related to the waiver of the CAH
and hospice participation requirements terminate upon expiration
of the COVID-19 PHE declared by the Secretary of HHS.