[Federal Register Volume 85, Number 226 (Monday, November 23, 2020)]
[Notices]
[Pages 74725-74729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25728]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
[CMS-6063-N6]
Medicare Program; National Expansion of the Prior Authorization
Model for Repetitive, Scheduled Non-Emergent Ambulance Transports
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces the national expansion of the Prior
Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance
Transports to all states, but we are delaying the implementation of the
expansion to all additional states due to
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the COVID-19 Public Health Emergency. The model will continue to
operate in the states currently participating in the model under
section 1115A of the Social Security Act (the Act), which includes
Delaware, the District of Columbia, Maryland, New Jersey, North
Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia.
CMS will continue to monitor the Public Health Emergency and will
provide public notice before implementing the model in additional
states.
DATES: This national expansion begins on December 2, 2020 in Delaware,
the District of Columbia, Maryland, New Jersey, North Carolina,
Pennsylvania, South Carolina, Virginia, and West Virginia.
FOR FURTHER INFORMATION CONTACT: Angela Gaston, (410) 786-7409.
Questions regarding the national expansion of the Prior
Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance
Transports should be sent to AmbulancePA@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. Overview
Section 1115A of the Act authorizes the Secretary to test
innovative payment and service delivery models expected to reduce
program expenditures, while preserving or enhancing the quality of care
furnished to Medicare, Medicaid, and Children's Health Insurance
Program beneficiaries. In the November 14, 2014 Federal Register (79 FR
68271), we published a notice entitled ``Medicare Program; Prior
Authorization of Repetitive, Scheduled Nonemergent Ambulance
Transports,'' which announced the implementation of a 3-year Medicare
prior authorization model under the authority of section 1115A of the
Act that established a process for requesting prior authorization for
repetitive, scheduled non-emergent ambulance transport rendered by
ambulance 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.
We chose to test this model on repetitive, scheduled non-emergent
ambulance transports because these services have been historically
vulnerable to improper payments. According to a study published by the
Government Accountability Office in October 2012, entitled ``Ambulance
Providers: Costs and Medicare Margins Varied Widely; Transports of
Beneficiaries Have Increased,'' \1\ 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 (OIG) in a 2006 study, entitled ``Medicare
Payments for Ambulance Transports,'' \2\ 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 \3\ 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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\1\ Government Accountability Office ``Ambulance Providers: Cost
and Medicare Margins Varied Widely; Transports of Beneficiaries Have
Increased'' (GAO-13-6) (October 2012).
\2\ Office of Inspector General ``Medicare Payment for Ambulance
Transport'' (January 2006).
\3\ Medicare Payment Advisory Commission, June 2013, pages 167-
193.
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In the October 23, 2015 Federal Register (80 FR 64418), we
published a notice titled ``Medicare Program; Expansion of Prior
Authorization for 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 Prior Authorization Model for
Repetitive, Scheduled Non-Emergent Ambulance Transports 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.
We extended the model for 3 additional years through December 1,
2020, as announced in the December 12, 2017 Federal Register (82 FR
58400), the December 4, 2018 Federal Register (83 FR 62577), and the
September 16, 2019 Federal Register (84 FR 48620).
B. Expansion Criteria
Section 515(b) of MACRA (Pub. L. 114-10) added paragraph (16) to
section 1834(l) of the Act, which requires that, beginning January 1,
2017, the Secretary expand the Prior Authorization Model for
Repetitive, Scheduled Non-Emergent Ambulance Transports nationally to
all states if an expansion to all states meets certain statutory
requirements for expansion of models tested under section 1115A of the
Act. These requirements are described in paragraphs (1) through (3) of
section 1115A(c) of the Act, and include the following:
The Secretary determines that such expansion is expected
to--
++ Reduce spending under applicable title without reducing the
quality of care; or
++ Improve the quality of patient care without increasing spending.
The Chief Actuary of CMS certifies that such expansion
would reduce (or would not result in any increase in) net program
spending under applicable titles.
The Secretary determines that such expansion would not
deny or limit the coverage or provision of benefits under the
applicable title for applicable individuals.
To date, we have released two interim evaluation reports conducted
by CMS contractor, Mathematica Policy Research. Most recently, the
Second Interim Evaluation Report \4\ found that the model was
successful in reducing repetitive, scheduled non-emergent ambulance
transport spending and total Medicare spending while maintaining
overall quality of and access to care. These findings were similar to
the First Interim Evaluation Report.\5\ In comparison to groups of
similar states, the model has reduced both repetitive, scheduled non-
emergent ambulance transport use and expenditures, by 63 percent and 72
percent, respectively, in the model states, resulting in a reduction of
approximately $550 million in expenditures over 4 years for the
population examined: Beneficiaries with end-stage renal disease, severe
pressure ulcers, or both. The evaluation reports found that the prior
authorization model overall had no impact on quality measures or
adverse events.
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\4\ https://innovation.cms.gov/data-and-reports/2020/rsnat-secondintevalrpt.
\5\ https://innovation.cms.gov/files/reports/rsnat-firstintevalrpt.pdf.
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On March 28, 2018, the Chief Actuary of CMS certified that
expansion of the model would reduce program spending under the Medicare
program, thereby satisfying the requirements of section 1115A(c)(2) of
the Act, stating that even under the most conservative assumptions, the
projected savings from expansion would significantly outweigh
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the cost of administering the prior authorization policy.\6\
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\6\ https://www.cms.gov/files/document/certification-medicare-prior-authorization-model-repetitive-scheduled-non-emergent-ambulance.pdf.
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On May 29, 2019, the Secretary of the Department of Health and
Human Services (the Secretary) determined that the model met the
statutory criteria for expansion under sections 1115A(c)(1) and (c)(3)
of the Act. CMS is therefore required under section 1834(l)(16) of the
Act, as added by section 515(b) of MACRA (Pub. L. 114-10), to expand
the model nationwide.
C. Medicare Ambulance Benefit
Medicare may cover ambulance services, including ground (land and
water) and air ambulance (fixed-wing and rotary-wing) transport
services, only if the ambulance transport service is furnished to a
beneficiary whose medical condition is such that other means of
transportation are contraindicated, to the nearest appropriate
facility. 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.\7\
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\7\ 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.\8\ Repetitive ambulance services are often needed by
beneficiaries receiving dialysis or cancer treatment.
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\8\ 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(e)(1) and
(2)).\9\
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\9\ Per 42 CFR 410.40(e)(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 http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c10.pdf.
II. Provisions of the Notice
This notice announces the national expansion of the Prior
Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance
Transports to all states under section 1834(l)(16) of the Act, as added
by section 515(b) of MACRA (Pub. L. 114-10). Due to the COVID-19 Public
Health Emergency, we are delaying the implementation of the expansion
to all additional states. The Prior Authorization Model for Repetitive,
Scheduled Non-Emergent Ambulance Transports currently operating under
section 1115A of the Act will transition to the national model on
December 2, 2020. This transition will include independent ambulance
suppliers garaged in Delaware, the District of Columbia, Maryland, New
Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and
West Virginia. CMS will continue to monitor the Public Health Emergency
and will provide public notice before implementing the model in
additional states.
We will continue to test whether prior authorization helps reduce
expenditures, while maintaining or improving quality of care, using the
prior authorization process described in this notice to reduce
utilization of services that do not comply with Medicare policy. Prior
authorization helps ensure that all relevant clinical or medical
documentation requirements are met before services are furnished to
beneficiaries and before claims are submitted for payment. It further
helps to ensure that payment complies with Medicare documentation,
coverage, payment, and coding rules.
The national expansion of the model will follow a similar design as
the Prior Authorization Model for Repetitive, Scheduled Non-Emergent
Ambulance Transports that operated under section 1115A of the Act. 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 also allows ambulance suppliers to address coverage
issues prior to furnishing services. Hospital-based ambulance providers
that are owned or operated by a hospital or both, critical access
hospital, skilled nursing facility, comprehensive outpatient
rehabilitation facility, home health agency, or hospice program have
not been included in the current model, and are not included in the
national model and should not request prior authorization.
For the national expansion of the model, the prior authorization
process will apply in all states and the District of Columbia to the
following Healthcare Common Procedure Coding System (HCPCS) 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.
Submitting a prior authorization request is voluntary. However, an
ambulance supplier or beneficiary is encouraged to submit to the
Medicare Administrative Contractor (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 MAC will
make every effort to conduct a review and postmark the notification of
their decision on the prior authorization request within 10 business
days. Notification will be provided to the ambulance supplier and to
the beneficiary. If a prior authorization
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request is non-affirmed, the request can be resubmitted with additional
documentation. Unlimited resubmissions are allowed.
An ambulance 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 MAC may consider an extended affirmation period for
beneficiaries with a chronic condition that is deemed not likely to
improve over time. The prior authorization decision, justified by the
beneficiary's chronic condition, may affirm up to 120 round trips
(which equates to 240 one-way trips) per prior authorization request in
a 180-day period. The medical records must clearly indicate that the
condition is chronic, and the MAC must have established through two
previous prior authorization requests that the beneficiary's medical
condition has not changed or has deteriorated from previous requests
before allowing an extended affirmation period.
The following describes examples of various prior authorization
scenarios:
Scenario 1: When an ambulance 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
supplier and the beneficiary. When the subsequent claim is submitted to
the MAC by the ambulance 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. A claim could be denied for technical reasons,
however, such as a duplicate claim or a date of service after a
deceased beneficiary's date of death. CMS contractors may conduct
targeted prepayment and post payment reviews to ensure that claims are
accompanied by documentation not required or available during the prior
authorization process. In addition, it is possible that the
Comprehensive Error Rate Testing (CERT) contractor may select a claim
linked to an affirmed prior authorization decision for review as the
CERT contractor must review a random sample of claims for purposes of
estimating the Medicare improper payment rate.
Scenario 2: When an ambulance 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 supplier and to the
beneficiary advising them that Medicare will not pay for the service.
The supplier or beneficiary may then resubmit the request with
additional documentation showing that Medicare requirements have been
met. Alternatively, an ambulance 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
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 supplier or beneficiary
submits a prior authorization request with incomplete documentation, a
detailed decision letter will be sent to the ambulance supplier and to
the beneficiary, with an explanation of what information is missing.
The ambulance supplier or beneficiary can rectify the error(s) and
resubmit the prior authorization request with appropriate
documentation.
Scenario 4: If an ambulance 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 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
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 suppliers are providing
transports to the beneficiary during the same or overlapping time
period, the prior authorization decision will only cover the ambulance
supplier indicated in the provisionally affirmed prior authorization
request. Any ambulance 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.
We will expand outreach and education efforts to all states and the
District of Columbia on this prior authorization model to ambulance
suppliers, as well as beneficiaries, through such methods as an
operational guide, frequently asked questions (FAQs) on our website, a
physician letter explaining the ambulance suppliers' need for the
proper documentation, and educational events and materials issued by
the MACs.
We will work to limit any adverse impact on beneficiaries and to
educate beneficiaries about the model process. If an ambulance supplier
submits a claim associated with a non-affirmed prior authorization
decision, it will be denied and beneficiaries will continue to have all
applicable administrative appeal rights.
Additional information is available on the CMS website at http://go.cms.gov/PAAmbulance.
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III. Collection of Information Requirements
As required by chapter 35 of title 44, United States Code (the
Paperwork Reduction Act of 1995), the information collection burden
associated with this national model is currently approved under OMB
control number 0938-1380 which expires on August 31, 2023.
IV. Regulatory Impact Statement
This document announces an expansion of the 3-year Medicare Prior
Authorization Model for Repetitive Scheduled Non-emergent Ambulance
Transport. Therefore, there are no regulatory impact implications
associated with this notice.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Seema Verma, having reviewed and approved this document,
authorizes Lynette Wilson, who is the Federal Register Liaison, to
electronically sign this document for purposes of publication in the
Federal Register.
Authority: Section 1834(l)(16) of the Social Security Act (the
Act), as added by section 515(b) of MACRA (Pub. L. 114-10).
Dated: November 17, 2020.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2020-25728 Filed 11-20-20; 8:45 am]
BILLING CODE 4120-01-P