[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 [email protected].

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

[[Page 74727]]

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