Medicare Program; Extension of Prior Authorization for Repetitive Scheduled Non-Emergent Ambulance Transports, 62577-62580 [2018-26334]
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Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
specified time period
Æ Quantity of use over specified time
period
Æ Substance-related problems/
symptom count scales
➢ Functional Outcomes
Exclusions
Æ School performance and
educational attainment
D Attendance
D Grades/academic performance
D Graduation rates
D Entering higher education
(including trade schools)
Æ Social relationships
D Family functioning
D Peer relationships
Æ Case-control studies
Æ Cross-sectional studies
Æ Single-arm studies of behavioral
interventions
Æ Conference abstracts letters, and
other non-peer reviewed reports
Timing
➢ Harmful Consequences Associated
With SUD
Æ
D
Æ
•
D
D
D
D
•
D
D
D
Æ
•
•
•
Mental health outcomes
Suicidal ideation and behavior
Physical health outcomes
Mortality
All-cause
Drug-related, including fatal
overdose
Morbidity
Injuries (non-fatal)
Infections
HIV
Hepatitis C
Other sexually transmitted
infections
Legal outcomes
Arrests
Drunk or impaired driving
Contact with juvenile justice system
➢ Adverse Effects of Intervention(s)
Francis D. Chesley, Jr.,
Acting Deputy Director.
[FR Doc. 2018–26304 Filed 12–3–18; 8:45 am]
BILLING CODE 4160–90–P
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Notice of availability.
AGENCY:
NIOSH announces the
availability of the final National
Occupational Research Agenda for Oil
and Gas Extraction
DATES: The final document was
published on November 27, 2018 on the
CDC website.
ADDRESSES: The document may be
obtained at the following link: https://
www.cdc.gov/nora/councils/oilgas/
agenda.html
SUMMARY:
Frm 00018
Emily Novicki, M.A., M.P.H,
(NORACoordinator@cdc.gov), National
Institute for Occupational Safety and
Health, Centers for Disease Control and
Prevention, Mailstop E–20, 1600 Clifton
Road NE, Atlanta, GA 30329, phone
(404) 498–2581 (not a toll free number).
SUPPLEMENTARY INFORMATION: On July
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public review in the Federal Register
[83 FR 35485] of the draft version of the
National Occupational Research
Agenda for Oil and Gas Extraction. The
single comment received expressed
support.
Dated: November 29, 2018.
Frank J. Hearl,
Chief of Staff, National Institute for
Occupational Safety and Health, Centers for
Disease Control and Prevention.
Fmt 4703
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–6063–N4]
Medicare Program; Extension of Prior
Authorization for Repetitive Scheduled
Non-Emergent Ambulance Transports
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
Final National Occupational Research
Agenda for Oil and Gas Extraction
PO 00000
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2018–26315 Filed 12–3–18; 8:45 am]
• Any setting, including (but not
limited to) primary care, school,
outpatient, emergency department,
in-patient, intensive outpatient,
partial hospitalization, intensive
inpatient/residential, juvenile
justice
Exclude: laboratory-based
assessments.
[CDC–2018–0065; Docket Number NIOSH–
317]
• Published, peer reviewed articles and
data from clinicaltrials.gov
Æ Randomized controlled trials
(including cross-over trials)
D N ≥ 10 participants per study group
Æ Large nonrandomized comparative
studies with longitudinal follow-up
D N ≥ 100 participants per study
group
D Must report multiple regression,
other adjustment, matching,
propensity scoring, or other method
to account for confounding.
Æ Single arm pharmacologic studies
with at least 200 participants and
longitudinal follow-up (to identify
side-effects of medications)
Æ We will summarize information
from existing systematic reviews
Jkt 247001
Setting
Centers for Disease Control and
Prevention
Study Designs and Information Sources
17:36 Dec 03, 2018
• Any duration of treatment
• Duration of follow-up of at least a
month (but must be longitudinal
with separation in time between
intervention and outcomes)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Æ Side effects of pharmacologic
interventions
Æ Loss of privacy/confidentiality
Æ Stigmatization/discrimination
Æ Iatrogenic effects of group therapy
due to peer deviance
Æ Other reported adverse effects
ascribed to interventions
VerDate Sep<11>2014
specific to treatment of alcohol SUD
on college campuses
D SR eligible if inclusion criteria for
individual studies consistent with
our PICOTS criteria for individual
studies.
62577
Sfmt 4703
This notice announces a 1year extension of the Medicare Prior
Authorization Model for Repetitive
Scheduled Non-Emergent Ambulance
Transport. The extension of this model
is applicable to the following states and
the District of Columbia: Delaware,
Maryland, New Jersey, North Carolina,
Pennsylvania, South Carolina, Virginia,
and West Virginia.
DATES: This extension begins on
December 2, 2018 and ends on
December 1, 2019.
FOR FURTHER INFORMATION CONTACT:
Angela Gaston, (410) 786–7409.
Questions regarding the Medicare Prior
Authorization Model Extension for
Repetitive Scheduled Non-Emergent
Ambulance Transport should be sent to
AmbulancePA@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Medicare may cover ambulance
services, including air ambulance
(fixed-wing and rotary-wing) services, if
the ambulance service is furnished to a
beneficiary whose medical condition is
E:\FR\FM\04DEN1.SGM
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Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
such that other means of transportation
are contraindicated. The beneficiary’s
condition must require both the
ambulance transportation itself and the
level of service provided in order for the
billed service to be considered
medically necessary.
Non-emergent transportation by
ambulance is appropriate if either the—
(1) beneficiary is bed-confined and it is
documented that the beneficiary’s
condition is such that other methods of
transportation are contraindicated; or (2)
beneficiary’s medical condition,
regardless of bed confinement, is such
that transportation by ambulance is
medically required. Thus, bed
confinement is not the sole criterion in
determining the medical necessity of
non-emergent ambulance transportation;
rather, it is one factor that is considered
in medical necessity determinations.1
A repetitive ambulance service is
defined as medically necessary
ambulance transportation that is
furnished in 3 or more round trips
during a 10-day period, or at least 1
round trip per week for at least 3
weeks.2 Repetitive ambulance services
are often needed by beneficiaries
receiving dialysis or cancer treatment.
Medicare may cover repetitive,
scheduled non-emergent transportation
by ambulance if the—(1) medical
necessity requirements described
previously are met; and (2) ambulance
provider/supplier, before furnishing the
service to the beneficiary, obtains a
written order from the beneficiary’s
attending physician certifying that the
medical necessity requirements are met
(see 42 CFR 410.40(d)(1) and (2)).3
In addition to the medical necessity
requirements, the service must meet all
other Medicare coverage and payment
requirements, including requirements
relating to the origin and destination of
the transportation, vehicle and staff, and
billing and reporting. Additional
information about Medicare coverage of
ambulance services can be found in 42
CFR 410.40, 410.41, and in the Medicare
Benefit Policy Manual (Pub. 100–02),
Chapter 10, at https://www.cms.gov/
Regulations-and-Guidance/Guidance/
Manuals/downloads/bp102c10.pdf.
According to a study published by the
Government Accountability Office in
October 2012, entitled ‘‘Costs and
Medicare Margins Varied Widely;
Transports of Beneficiaries Have
1 42
CFR 410.40(d)(1).
2 Program Memorandum Intermediaries/Carriers,
Transmittal AB–03–106.
3 Per 42 CFR 410.40(d)(2), the physician’s order
must be dated no earlier than 60 days before the
date the service is furnished.
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17:36 Dec 03, 2018
Jkt 247001
Increased,’’ 4 the number of basic life
support (BLS) non-emergent transports
for Medicare Fee-For-Service
beneficiaries increased by 59 percent
from 2004 to 2010. A similar finding
published by the Department of Health
and Human Services’ Office of Inspector
General in a 2006 study, entitled
‘‘Medicare Payments for Ambulance
Transports,’’ 5 indicated a 20 percent
nationwide improper payment rate for
non-emergent ambulance transport.
Likewise, in June 2013, the Medicare
Payment Advisory Commission
published a report 6 that included an
analysis of non-emergent ambulance
transports to dialysis facilities and
found that, during the 5-year period
between 2007 and 2011, the volume of
transports to and from a dialysis facility
increased 20 percent, more than twice
the rate of all other ambulance
transports combined.
Section 1115A of the Social Security
Act (the Act) authorizes the Secretary to
test innovative payment and service
delivery models to reduce program
expenditures, while preserving or
enhancing the quality of care furnished
to Medicare, Medicaid, and Children’s
Health Insurance Program beneficiaries.
Section 1115A(d)(1) of the Act
authorizes the Secretary to waive such
requirements of Titles XI and XVIII, as
well as sections 1902(a)(1), 1902(a)(13),
1903(m)(2)(A)(iii), and 1934 (other than
subsections (b)(1)(A) and (c)(5)) of the
Act as may be necessary solely for
purposes of carrying out section 1115A
of the Act with respect to testing models
described in section 1115A(b) of the
Act. Consistent with this standard, we
will continue to waive the same
provisions for the extension of this
model as have been waived for the prior
4 years of the model. Additionally, we
have determined that the
implementation of this model does not
require the waiver of any fraud and
abuse law, including sections 1128A,
1128B, and 1877 of the Act. Thus
providers and suppliers affected by this
model must comply with all applicable
fraud and abuse laws.
In the November 14, 2014 Federal
Register (79 FR 68271), we published a
notice entitled ‘‘Medicare Program;
Prior Authorization of Repetitive
Scheduled Non-emergent Ambulance
Transports,’’ which announced the
implementation of a 3-year Medicare
Prior Authorization model that
4 Government Accountability Office Cost and
Medicare Margins Varied Widely; Transports of
Beneficiaries Have Increased (October 2012).
5 Office of Inspector General Medicare Payment
for Ambulance Transport (January 2006).
6 Medicare Payment Advisory Commission, June
2013, pages 167–193.
PO 00000
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Sfmt 4703
established a process for requesting
prior authorization for repetitive,
scheduled non-emergent ambulance
transport rendered by ambulance
providers/suppliers garaged in three
states (New Jersey, Pennsylvania, and
South Carolina). These states were
selected as the initial states for the
model because of their high utilization
and improper payment rates for these
services. The model began on December
1, 2014, and was originally scheduled to
end in all three states on December 1,
2017.
In the October 23, 2015 Federal
Register (80 FR 64418), we published a
notice titled ‘‘Medicare Program;
Expansion of Prior Authorization of
Repetitive Scheduled Non-emergent
Ambulance Transports,’’ which
announced the inclusion of six
additional states (Delaware, the District
of Columbia, Maryland, North Carolina,
West Virginia, and Virginia) in the
Repetitive Scheduled Non-Emergent
Ambulance Transport Prior
Authorization model in accordance with
section 515(a) of the Medicare Access
and CHIP Reauthorization Act of 2015
(MACRA) (Pub. L. 114–10). These six
states began participation on January 1,
2016, and the model was originally
scheduled to end in all nine model
states on December 1, 2017.
In the December 12, 2017 Federal
Register (82 FR 58400), we published a
notice titled ‘‘Medicare Program;
Extension of Prior Authorization for
Repetitive Scheduled Non-Emergent
Ambulance Transports,’’ which
announced a 1-year extension of the
prior authorization model in all states
through December 1, 2018.
II. Provisions of the Notice
This notice announces that the
Medicare Prior Authorization Model for
Repetitive Scheduled Non-Emergent
Ambulance Transport is again being
extended in the current model states of
Delaware, the District of Columbia,
Maryland, New Jersey, North Carolina,
Pennsylvania, South Carolina, Virginia,
and West Virginia for an additional year
while we continue to evaluate the
model and determine if the model meets
the statutory requirements for
nationwide expansion under section
1834(l)(16) of the the Act, as added by
section 515(b) of MACRA (Pub. L. 114–
10). The model is currently scheduled to
end in all states on December 1, 2019.
Prior authorization will not be available
for repetitive scheduled non-emergent
ambulance transportation services
furnished after that date.
We will continue to test whether prior
authorization helps reduce
expenditures, while maintaining or
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Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
improving quality of care, using the
established prior authorization process
for repetitive, scheduled non-emergent
ambulance transport to reduce
utilization of services that do not
comply with Medicare policy.
We will continue to use this prior
authorization process to help ensure
that all relevant clinical or medical
documentation requirements are met
before services are furnished to
beneficiaries and before claims are
submitted for payment. This prior
authorization process further helps to
ensure that payment complies with
Medicare documentation, coverage,
payment, and coding rules.
The use of prior authorization does
not create new clinical documentation
requirements. Instead, it requires the
same information that is already
required to support Medicare payment,
just earlier in the process. Prior
authorization allows providers and
suppliers to address coverage issues
prior to furnishing services.
The prior authorization process under
this model will continue to apply in the
nine states listed previously for the
following codes for Medicare payment:
• A0426 Ambulance service,
advanced life support, non-emergency
transport, Level 1 (ALS1).
• A0428 Ambulance service, BLS,
non-emergency transport.
While prior authorization is not
needed for the mileage code, A0425, a
prior authorization decision for an
A0426 or A0428 code will automatically
include the associated mileage code.
We have conducted and will continue
to conduct outreach and education to
ambulance providers/suppliers, as well
as beneficiaries, through such methods
as updating the operational guide,
frequently asked questions (FAQs) on
our website, a physician letter
explaining the ambulance providers/
suppliers’ need for the proper
documentation, and educational events
and materials issued by the Medicare
Administrative Contractors (MACs). We
will also continue our recent initiative
to help find alternative resources for
beneficiaries who do not meet the
requirements of the Medicare repetitive
scheduled non-emergent ambulance
transport benefit. Additional
information about the implementation
of the prior authorization model is
available on the CMS website at https://
go.cms.gov/PAAmbulance.
Under this model, submitting a prior
authorization request is voluntary.
However, an ambulance provider/
supplier or beneficiary is encouraged to
submit to the MAC a request for prior
authorization along with all relevant
documentation to support Medicare
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17:36 Dec 03, 2018
Jkt 247001
coverage of a repetitive, scheduled nonemergent ambulance transport. If prior
authorization has not been requested by
the fourth round trip in a 30-day period,
the subsequent claims will be stopped
for prepayment review.
In order for a prior authorization
request to be provisionally affirmed, the
request for prior authorization must
meet all applicable rules and policies,
including any local coverage
determination (LCD) requirements for
ambulance transport claims. A
provisional affirmation is a preliminary
finding that a future claim submitted to
Medicare for the service likely meets
Medicare’s coverage, coding, and
payment requirements. After receipt of
all relevant documentation, the MACs
will make every effort to conduct a
review and postmark the notification of
their decision on a prior authorization
request within 10 business days for an
initial submission. Notification will be
provided to the ambulance provider/
supplier and to the beneficiary. If a
subsequent prior authorization request
is submitted after a non-affirmative
decision on an initial prior
authorization request, the MACs will
make every effort to conduct a review
and postmark the notification of their
decision on the resubmitted request
within 20 business days.
An ambulance provider/supplier or
beneficiary may request an expedited
review when the standard timeframe for
making a prior authorization decision
could jeopardize the life or health of the
beneficiary. If the MAC agrees that the
standard review timeframe would put
the beneficiary at risk, the MAC will
make reasonable efforts to communicate
a decision within 2 business days of
receipt of all applicable Medicarerequired documentation. As this model
is for non-emergent services only, we
expect requests for expedited reviews to
be extremely rare.
A provisional affirmative prior
authorization decision may affirm a
specified number of trips within a
specific amount of time. The prior
authorization decision, justified by the
beneficiary’s condition, may affirm up
to 40 round trips (which equates to 80
one-way trips) per prior authorization
request in a 60-day period.
Alternatively, a provisional affirmative
decision may affirm less than 40 round
trips in a 60-day period, or may affirm
a request that seeks to provide a
specified number of transports (40
round trips or less) in less than a 60-day
period. A provisional affirmative
decision can be for all or part of the
requested number of trips. Transports
exceeding 40 round trips (or 80 one-way
PO 00000
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Sfmt 4703
62579
trips) in a 60-day period require an
additional prior authorization request.
The following describes examples of
various prior authorization scenarios:
• Scenario 1: When an ambulance
provider/supplier or beneficiary submits
a prior authorization request to the MAC
with appropriate documentation and all
relevant Medicare coverage and
documentation requirements are met for
the ambulance transport, the MAC will
send a provisional affirmative prior
authorization decision to the ambulance
provider/supplier and the beneficiary.
When the subsequent claim is submitted
to the MAC by the ambulance provider/
supplier, it is linked to the prior
authorization decision via the claims
processing system, and the claim will be
paid so long as all Medicare coding,
billing, and coverage requirements are
met. However, the claim could be
denied for technical reasons, such as the
claim was a duplicate claim or the claim
was for a deceased beneficiary. In
addition, a claim denial could occur
because certain documentation, such as
the trip record, needed in support of the
claim cannot be submitted with a prior
authorization request because it is not
available until after the service is
provided.
• Scenario 2: When an ambulance
provider/supplier or beneficiary submits
a prior authorization request, but all
relevant Medicare coverage
requirements are not met, the MAC will
send a non-affirmative prior
authorization decision to the ambulance
provider/supplier and to the beneficiary
advising them that Medicare will not
pay for the service. The provider/
supplier or beneficiary may then
resubmit the request with additional
documentation showing that Medicare
requirements have been met.
Alternatively, an ambulance provider/
supplier could furnish the service and
submit a claim with a non-affirmative
prior authorization tracking number, at
which point the MAC would deny the
claim. The ambulance provider/supplier
and the beneficiary would then have the
Medicare denial for secondary
insurance purposes and would have the
opportunity to submit an appeal of the
claim denial if they believe Medicare
coverage was denied inappropriately.
• Scenario 3: When an ambulance
provider/supplier or beneficiary submits
a prior authorization request with
incomplete documentation, a detailed
decision letter will be sent to the
ambulance provider/supplier and to the
beneficiary, with an explanation of what
information is missing. The ambulance
provider/supplier or beneficiary can
rectify the error(s) and resubmit the
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Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
prior authorization request with
appropriate documentation.
• Scenario 4: If an ambulance
provider or supplier renders a service to
a beneficiary and does not request prior
authorization by the fourth round trip in
a 30-day period, and the claim is
submitted to the MAC for payment, then
the claim will be stopped for
prepayment review and documentation
will be requested.
++ If the claim is determined to be for
services that were not medically
necessary or for which there was
insufficient documentation, the claim
will be denied, and all current policies
and procedures regarding liability for
payment will apply. The ambulance
provider/supplier or the beneficiary, or
both, can appeal the claim denial if they
believe the denial was inappropriate.
++ If the claim is determined to be
payable, it will be paid.
Only one prior authorization request
per beneficiary per designated time
period can be provisionally affirmed. If
the initial ambulance provider/supplier
cannot complete the total number of
prior authorized transports (for
example, the initial ambulance
company closes or no longer services
that area), the initial request is
cancelled. In this situation, a
subsequent prior authorization request
may be submitted for the same
beneficiary and must include the
required documentation in the
submission. If multiple ambulance
providers/suppliers are providing
transports to the beneficiary during the
same or overlapping time period, the
prior authorization decision will only
cover the ambulance provider/supplier
indicated in the provisionally affirmed
prior authorization request. Any
ambulance provider/supplier submitting
claims for repetitive, scheduled nonemergent ambulance transports for
which no prior authorization request is
submitted by the fourth round trip in a
30-day period will be subject to 100
percent prepayment medical review of
those claims.
Under the model, we will work to
limit any adverse impact on
beneficiaries and to educate
beneficiaries about the process. If a prior
authorization request is non-affirmed,
and the claim is still submitted by the
ambulance provider/supplier, the claim
will be denied, but beneficiaries will
continue to have all applicable
administrative appeal rights. We have
also recently implemented a process to
help find alternative resources for
beneficiaries who do not meet the
requirements of the Medicare repetitive
scheduled non-emergent ambulance
transport benefit.
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17:36 Dec 03, 2018
Jkt 247001
Additional information is available on
the CMS website at https://go.cms.gov/
PAAmbulance.
III. Collection of Information
Requirements
Section 1115A(d)(3) of the Act states
that chapter 35 of title 44, United States
Code (the Paperwork Reduction Act of
1995), shall not apply to the testing and
evaluation of models or expansion of
such models under this section.
Consequently, this document need not
be reviewed by the Office of
Management and Budget under the
authority of the Paperwork Reduction
Act of 1995.
IV. Regulatory Impact Statement
This document announces a 1-year
extension of the Medicare Prior
Authorization Model for Repetitive
Scheduled Non-Emergent Ambulance
Transport. Therefore, there are no
regulatory impact implications
associated with this notice.
Authority: Section 1115A of the Act.
Dated: November 27, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2018–26334 Filed 11–30–18; 11:15 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–E–2801]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ASPIRE ASSIST
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for ASPIRE ASSIST and is publishing
this notice of that determination as
required by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that medical
device.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by February 4, 2019.
DATES:
PO 00000
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Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
June 3, 2019. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before February 4,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 3, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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the docket unchanged. Because your
comment will be made public, you are
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as a manufacturing process. Please note
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information, or other information that
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comments, that information will be
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• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
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Submit written/paper submissions as
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• For written/paper comments
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Agencies
[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Notices]
[Pages 62577-62580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26334]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-6063-N4]
Medicare Program; Extension of Prior Authorization for Repetitive
Scheduled Non-Emergent Ambulance Transports
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces a 1-year extension of the Medicare Prior
Authorization Model for Repetitive Scheduled Non-Emergent Ambulance
Transport. The extension of this model is applicable to the following
states and the District of Columbia: Delaware, Maryland, New Jersey,
North Carolina, Pennsylvania, South Carolina, Virginia, and West
Virginia.
DATES: This extension begins on December 2, 2018 and ends on December
1, 2019.
FOR FURTHER INFORMATION CONTACT: Angela Gaston, (410) 786-7409.
Questions regarding the Medicare Prior Authorization Model Extension
for Repetitive Scheduled Non-Emergent Ambulance Transport should be
sent to [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Medicare may cover ambulance services, including air ambulance
(fixed-wing and rotary-wing) services, if the ambulance service is
furnished to a beneficiary whose medical condition is
[[Page 62578]]
such that other means of transportation are contraindicated. The
beneficiary's condition must require both the ambulance transportation
itself and the level of service provided in order for the billed
service to be considered medically necessary.
Non-emergent transportation by ambulance is appropriate if either
the-- (1) beneficiary is bed-confined and it is documented that the
beneficiary's condition is such that other methods of transportation
are contraindicated; or (2) beneficiary's medical condition, regardless
of bed confinement, is such that transportation by ambulance is
medically required. Thus, bed confinement is not the sole criterion in
determining the medical necessity of non-emergent ambulance
transportation; rather, it is one factor that is considered in medical
necessity determinations.\1\
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\1\ 42 CFR 410.40(d)(1).
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A repetitive ambulance service is defined as medically necessary
ambulance transportation that is furnished in 3 or more round trips
during a 10-day period, or at least 1 round trip per week for at least
3 weeks.\2\ Repetitive ambulance services are often needed by
beneficiaries receiving dialysis or cancer treatment.
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\2\ Program Memorandum Intermediaries/Carriers, Transmittal AB-
03-106.
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Medicare may cover repetitive, scheduled non-emergent
transportation by ambulance if the--(1) medical necessity requirements
described previously are met; and (2) ambulance provider/supplier,
before furnishing the service to the beneficiary, obtains a written
order from the beneficiary's attending physician certifying that the
medical necessity requirements are met (see 42 CFR 410.40(d)(1) and
(2)).\3\
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\3\ Per 42 CFR 410.40(d)(2), the physician's order must be dated
no earlier than 60 days before the date the service is furnished.
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In addition to the medical necessity requirements, the service must
meet all other Medicare coverage and payment requirements, including
requirements relating to the origin and destination of the
transportation, vehicle and staff, and billing and reporting.
Additional information about Medicare coverage of ambulance services
can be found in 42 CFR 410.40, 410.41, and in the Medicare Benefit
Policy Manual (Pub. 100-02), Chapter 10, at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c10.pdf.
According to a study published by the Government Accountability
Office in October 2012, entitled ``Costs and Medicare Margins Varied
Widely; Transports of Beneficiaries Have Increased,'' \4\ the number of
basic life support (BLS) non-emergent transports for Medicare Fee-For-
Service beneficiaries increased by 59 percent from 2004 to 2010. A
similar finding published by the Department of Health and Human
Services' Office of Inspector General in a 2006 study, entitled
``Medicare Payments for Ambulance Transports,'' \5\ indicated a 20
percent nationwide improper payment rate for non-emergent ambulance
transport. Likewise, in June 2013, the Medicare Payment Advisory
Commission published a report \6\ that included an analysis of non-
emergent ambulance transports to dialysis facilities and found that,
during the 5-year period between 2007 and 2011, the volume of
transports to and from a dialysis facility increased 20 percent, more
than twice the rate of all other ambulance transports combined.
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\4\ Government Accountability Office Cost and Medicare Margins
Varied Widely; Transports of Beneficiaries Have Increased (October
2012).
\5\ Office of Inspector General Medicare Payment for Ambulance
Transport (January 2006).
\6\ Medicare Payment Advisory Commission, June 2013, pages 167-
193.
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Section 1115A of the Social Security Act (the Act) authorizes the
Secretary to test innovative payment and service delivery models to
reduce program expenditures, while preserving or enhancing the quality
of care furnished to Medicare, Medicaid, and Children's Health
Insurance Program beneficiaries. Section 1115A(d)(1) of the Act
authorizes the Secretary to waive such requirements of Titles XI and
XVIII, as well as sections 1902(a)(1), 1902(a)(13), 1903(m)(2)(A)(iii),
and 1934 (other than subsections (b)(1)(A) and (c)(5)) of the Act as
may be necessary solely for purposes of carrying out section 1115A of
the Act with respect to testing models described in section 1115A(b) of
the Act. Consistent with this standard, we will continue to waive the
same provisions for the extension of this model as have been waived for
the prior 4 years of the model. Additionally, we have determined that
the implementation of this model does not require the waiver of any
fraud and abuse law, including sections 1128A, 1128B, and 1877 of the
Act. Thus providers and suppliers affected by this model must comply
with all applicable fraud and abuse laws.
In the November 14, 2014 Federal Register (79 FR 68271), we
published a notice entitled ``Medicare Program; Prior Authorization of
Repetitive Scheduled Non-emergent Ambulance Transports,'' which
announced the implementation of a 3-year Medicare Prior Authorization
model that established a process for requesting prior authorization for
repetitive, scheduled non-emergent ambulance transport rendered by
ambulance providers/suppliers garaged in three states (New Jersey,
Pennsylvania, and South Carolina). These states were selected as the
initial states for the model because of their high utilization and
improper payment rates for these services. The model began on December
1, 2014, and was originally scheduled to end in all three states on
December 1, 2017.
In the October 23, 2015 Federal Register (80 FR 64418), we
published a notice titled ``Medicare Program; Expansion of Prior
Authorization of Repetitive Scheduled Non-emergent Ambulance
Transports,'' which announced the inclusion of six additional states
(Delaware, the District of Columbia, Maryland, North Carolina, West
Virginia, and Virginia) in the Repetitive Scheduled Non-Emergent
Ambulance Transport Prior Authorization model in accordance with
section 515(a) of the Medicare Access and CHIP Reauthorization Act of
2015 (MACRA) (Pub. L. 114-10). These six states began participation on
January 1, 2016, and the model was originally scheduled to end in all
nine model states on December 1, 2017.
In the December 12, 2017 Federal Register (82 FR 58400), we
published a notice titled ``Medicare Program; Extension of Prior
Authorization for Repetitive Scheduled Non-Emergent Ambulance
Transports,'' which announced a 1-year extension of the prior
authorization model in all states through December 1, 2018.
II. Provisions of the Notice
This notice announces that the Medicare Prior Authorization Model
for Repetitive Scheduled Non-Emergent Ambulance Transport is again
being extended in the current model states of Delaware, the District of
Columbia, Maryland, New Jersey, North Carolina, Pennsylvania, South
Carolina, Virginia, and West Virginia for an additional year while we
continue to evaluate the model and determine if the model meets the
statutory requirements for nationwide expansion under section
1834(l)(16) of the the Act, as added by section 515(b) of MACRA (Pub.
L. 114-10). The model is currently scheduled to end in all states on
December 1, 2019. Prior authorization will not be available for
repetitive scheduled non-emergent ambulance transportation services
furnished after that date.
We will continue to test whether prior authorization helps reduce
expenditures, while maintaining or
[[Page 62579]]
improving quality of care, using the established prior authorization
process for repetitive, scheduled non-emergent ambulance transport to
reduce utilization of services that do not comply with Medicare policy.
We will continue to use this prior authorization process to help
ensure that all relevant clinical or medical documentation requirements
are met before services are furnished to beneficiaries and before
claims are submitted for payment. This prior authorization process
further helps to ensure that payment complies with Medicare
documentation, coverage, payment, and coding rules.
The use of prior authorization does not create new clinical
documentation requirements. Instead, it requires the same information
that is already required to support Medicare payment, just earlier in
the process. Prior authorization allows providers and suppliers to
address coverage issues prior to furnishing services.
The prior authorization process under this model will continue to
apply in the nine states listed previously for the following codes for
Medicare payment:
A0426 Ambulance service, advanced life support, non-
emergency transport, Level 1 (ALS1).
A0428 Ambulance service, BLS, non-emergency transport.
While prior authorization is not needed for the mileage code,
A0425, a prior authorization decision for an A0426 or A0428 code will
automatically include the associated mileage code.
We have conducted and will continue to conduct outreach and
education to ambulance providers/suppliers, as well as beneficiaries,
through such methods as updating the operational guide, frequently
asked questions (FAQs) on our website, a physician letter explaining
the ambulance providers/suppliers' need for the proper documentation,
and educational events and materials issued by the Medicare
Administrative Contractors (MACs). We will also continue our recent
initiative to help find alternative resources for beneficiaries who do
not meet the requirements of the Medicare repetitive scheduled non-
emergent ambulance transport benefit. Additional information about the
implementation of the prior authorization model is available on the CMS
website at https://go.cms.gov/PAAmbulance.
Under this model, submitting a prior authorization request is
voluntary. However, an ambulance provider/supplier or beneficiary is
encouraged to submit to the MAC a request for prior authorization along
with all relevant documentation to support Medicare coverage of a
repetitive, scheduled non-emergent ambulance transport. If prior
authorization has not been requested by the fourth round trip in a 30-
day period, the subsequent claims will be stopped for prepayment
review.
In order for a prior authorization request to be provisionally
affirmed, the request for prior authorization must meet all applicable
rules and policies, including any local coverage determination (LCD)
requirements for ambulance transport claims. A provisional affirmation
is a preliminary finding that a future claim submitted to Medicare for
the service likely meets Medicare's coverage, coding, and payment
requirements. After receipt of all relevant documentation, the MACs
will make every effort to conduct a review and postmark the
notification of their decision on a prior authorization request within
10 business days for an initial submission. Notification will be
provided to the ambulance provider/supplier and to the beneficiary. If
a subsequent prior authorization request is submitted after a non-
affirmative decision on an initial prior authorization request, the
MACs will make every effort to conduct a review and postmark the
notification of their decision on the resubmitted request within 20
business days.
An ambulance provider/supplier or beneficiary may request an
expedited review when the standard timeframe for making a prior
authorization decision could jeopardize the life or health of the
beneficiary. If the MAC agrees that the standard review timeframe would
put the beneficiary at risk, the MAC will make reasonable efforts to
communicate a decision within 2 business days of receipt of all
applicable Medicare-required documentation. As this model is for non-
emergent services only, we expect requests for expedited reviews to be
extremely rare.
A provisional affirmative prior authorization decision may affirm a
specified number of trips within a specific amount of time. The prior
authorization decision, justified by the beneficiary's condition, may
affirm up to 40 round trips (which equates to 80 one-way trips) per
prior authorization request in a 60-day period. Alternatively, a
provisional affirmative decision may affirm less than 40 round trips in
a 60-day period, or may affirm a request that seeks to provide a
specified number of transports (40 round trips or less) in less than a
60-day period. A provisional affirmative decision can be for all or
part of the requested number of trips. Transports exceeding 40 round
trips (or 80 one-way trips) in a 60-day period require an additional
prior authorization request.
The following describes examples of various prior authorization
scenarios:
Scenario 1: When an ambulance provider/supplier or
beneficiary submits a prior authorization request to the MAC with
appropriate documentation and all relevant Medicare coverage and
documentation requirements are met for the ambulance transport, the MAC
will send a provisional affirmative prior authorization decision to the
ambulance provider/supplier and the beneficiary. When the subsequent
claim is submitted to the MAC by the ambulance provider/supplier, it is
linked to the prior authorization decision via the claims processing
system, and the claim will be paid so long as all Medicare coding,
billing, and coverage requirements are met. However, the claim could be
denied for technical reasons, such as the claim was a duplicate claim
or the claim was for a deceased beneficiary. In addition, a claim
denial could occur because certain documentation, such as the trip
record, needed in support of the claim cannot be submitted with a prior
authorization request because it is not available until after the
service is provided.
Scenario 2: When an ambulance provider/supplier or
beneficiary submits a prior authorization request, but all relevant
Medicare coverage requirements are not met, the MAC will send a non-
affirmative prior authorization decision to the ambulance provider/
supplier and to the beneficiary advising them that Medicare will not
pay for the service. The provider/supplier or beneficiary may then
resubmit the request with additional documentation showing that
Medicare requirements have been met. Alternatively, an ambulance
provider/supplier could furnish the service and submit a claim with a
non-affirmative prior authorization tracking number, at which point the
MAC would deny the claim. The ambulance provider/supplier and the
beneficiary would then have the Medicare denial for secondary insurance
purposes and would have the opportunity to submit an appeal of the
claim denial if they believe Medicare coverage was denied
inappropriately.
Scenario 3: When an ambulance provider/supplier or
beneficiary submits a prior authorization request with incomplete
documentation, a detailed decision letter will be sent to the ambulance
provider/supplier and to the beneficiary, with an explanation of what
information is missing. The ambulance provider/supplier or beneficiary
can rectify the error(s) and resubmit the
[[Page 62580]]
prior authorization request with appropriate documentation.
Scenario 4: If an ambulance provider or supplier renders a
service to a beneficiary and does not request prior authorization by
the fourth round trip in a 30-day period, and the claim is submitted to
the MAC for payment, then the claim will be stopped for prepayment
review and documentation will be requested.
++ If the claim is determined to be for services that were not
medically necessary or for which there was insufficient documentation,
the claim will be denied, and all current policies and procedures
regarding liability for payment will apply. The ambulance provider/
supplier or the beneficiary, or both, can appeal the claim denial if
they believe the denial was inappropriate.
++ If the claim is determined to be payable, it will be paid.
Only one prior authorization request per beneficiary per designated
time period can be provisionally affirmed. If the initial ambulance
provider/supplier cannot complete the total number of prior authorized
transports (for example, the initial ambulance company closes or no
longer services that area), the initial request is cancelled. In this
situation, a subsequent prior authorization request may be submitted
for the same beneficiary and must include the required documentation in
the submission. If multiple ambulance providers/suppliers are providing
transports to the beneficiary during the same or overlapping time
period, the prior authorization decision will only cover the ambulance
provider/supplier indicated in the provisionally affirmed prior
authorization request. Any ambulance provider/supplier submitting
claims for repetitive, scheduled non-emergent ambulance transports for
which no prior authorization request is submitted by the fourth round
trip in a 30-day period will be subject to 100 percent prepayment
medical review of those claims.
Under the model, we will work to limit any adverse impact on
beneficiaries and to educate beneficiaries about the process. If a
prior authorization request is non-affirmed, and the claim is still
submitted by the ambulance provider/supplier, the claim will be denied,
but beneficiaries will continue to have all applicable administrative
appeal rights. We have also recently implemented a process to help find
alternative resources for beneficiaries who do not meet the
requirements of the Medicare repetitive scheduled non-emergent
ambulance transport benefit.
Additional information is available on the CMS website at https://go.cms.gov/PAAmbulance.
III. Collection of Information Requirements
Section 1115A(d)(3) of the Act states that chapter 35 of title 44,
United States Code (the Paperwork Reduction Act of 1995), shall not
apply to the testing and evaluation of models or expansion of such
models under this section. Consequently, this document need not be
reviewed by the Office of Management and Budget under the authority of
the Paperwork Reduction Act of 1995.
IV. Regulatory Impact Statement
This document announces a 1-year extension of the Medicare Prior
Authorization Model for Repetitive Scheduled Non-Emergent Ambulance
Transport. Therefore, there are no regulatory impact implications
associated with this notice.
Authority: Section 1115A of the Act.
Dated: November 27, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-26334 Filed 11-30-18; 11:15 am]
BILLING CODE 4120-01-P