80_FR_64623 80 FR 64418 - Medicare Program; Expansion of Prior Authorization for Repetitive Scheduled Non-Emergent Ambulance Transports

80 FR 64418 - Medicare Program; Expansion of Prior Authorization for Repetitive Scheduled Non-Emergent Ambulance Transports

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 80, Issue 205 (October 23, 2015)

Page Range64418-64421
FR Document2015-27030

This notice announces an expansion of the 3-year Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport in accordance with section 515(a) of the Medicare Access and CHIP Reauthorization Act of 2015. The model is being expanded to the states of Maryland, Delaware, the District of Columbia, North Carolina, West Virginia, and Virginia.

Federal Register, Volume 80 Issue 205 (Friday, October 23, 2015)
[Federal Register Volume 80, Number 205 (Friday, October 23, 2015)]
[Notices]
[Pages 64418-64421]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27030]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-6063-N2]


Medicare Program; Expansion of Prior Authorization 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 an expansion of the 3-year Medicare 
Prior Authorization Model for Repetitive Scheduled Non-Emergent 
Ambulance Transport in accordance with section 515(a) of the Medicare 
Access and CHIP Reauthorization Act of 2015. The model is being 
expanded to the states of Maryland, Delaware, the District of Columbia, 
North Carolina, West Virginia, and Virginia.

DATES: This expansion will begin on January 1, 2016 in Maryland, 
Delaware,

[[Page 64419]]

the District of Columbia, North Carolina, Virginia, and West Virginia.

FOR FURTHER INFORMATION CONTACT: Angela Gaston, (410) 786-7409.
    Questions regarding the Medicare Prior Authorization Model 
Expansion for Repetitive Scheduled Non-Emergent Ambulance Transport 
should be sent to AmbulancePA@cms.hhs.gov.

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 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 http://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.
---------------------------------------------------------------------------

    \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 and of sections 1902(a)(1), 
1902(a)(13), and 1903(m)(2)(A)(iii) 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. For 
these models, consistent with this standard, we will waive such 
provisions of sections 1834(a)(15) and 1869(h) of the Act that limit 
our ability to conduct prior authorization. While these provisions are 
specific to durable medical equipment and physicians' services, we will 
waive any portion of these sections as well as any portion of 42 CFR 
410.20(d), which implements section 1869(h) of the Act, that could be 
construed to limit our ability to conduct prior authorization. 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.

II. Provisions of the Notice

    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 seeking prior authorizations for 
repetitive scheduled non-emergent ambulance transport rendered by 
ambulance providers/suppliers garaged in 3 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 will end in all 3 states on December 1, 2017. Prior 
authorization will not apply to or be given for services furnished 
after that date.
    Section 515(a) of the Medicare Access and CHIP Reauthorization Act 
of 2015 (MACRA) (Pub. L. 114-10), requires expansion of the previously 
referenced prior authorization model to cover, effective not later than 
January 1, 2016, states located in Medicare Administrative Contractor 
(MAC) regions L and 11 (consisting of Delaware, the District of 
Columbia, Maryland, New Jersey, Pennsylvania, North Carolina, South 
Carolina, West Virginia, and Virginia). As such, in accordance with 
section 515(a) of MACRA, our initial expansion of the prior 
authorization model for repetitive scheduled non-emergent ambulance 
transport will include six additional states: Delaware, the District of 
Columbia, Maryland, North Carolina, Virginia, and West Virginia. This 
expansion will begin on January 1, 2016. The model will end in all 
states on December 1, 2017. Prior authorization will not apply to or be 
given for services furnished after that date.
    We will continue to test whether prior authorization helps reduce

[[Page 64420]]

expenditures, while maintaining or 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 apply in the 
additional six 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 in the additional six states 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.
    Prior to the start of the expansion, we will conduct (and 
thereafter will continue to conduct) outreach and education to 
ambulance providers/suppliers, as well as beneficiaries, through such 
methods as the issuance of an operational guide, frequently asked 
questions (FAQs) on our Web site, a beneficiary mailing, a physician 
letter explaining the ambulance providers/suppliers' need for the 
proper documentation, and educational events and materials issued by 
the MACs. Additional information about the implementation of the prior 
authorization model is available on the CMS Web site at http://go.cms.gov/PAAmbulance.
    Under this model, 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. Submitting a 
prior authorization request is voluntary. However, if prior 
authorization has not been requested by the fourth round trip in a 30-
day period, the claims will be stopped for pre-payment review.
    In order to be provisionally affirmed, the request for prior 
authorization must meet all applicable rules and policies, and 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 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 prior authorization 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 to the beneficiary. When the claim is 
submitted to the MAC by the ambulance provider/supplier, it is linked 
to the prior authorization via the claims processing system and the 
claim will be paid so long as all Medicare coding, billing, and 
coverage requirements are met. However, after submission, 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 
reviewed on a prior authorization request.
     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 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 situation and resubmit the prior authorization request 
with appropriate documentation.
     Scenario 4: When an ambulance provider or supplier renders 
a service to

[[Page 64421]]

a beneficiary that is subject to the prior authorization process, and 
the claim is submitted to the MAC for payment without requesting a 
prior authorization, the claim will be stopped for prepayment review 
and documentation will be requested.
    ++ If the claim is determined not to be medically necessary or to 
be insufficiently documented, 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.
    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 not affirmed, and the claim is still 
submitted by the provider/supplier, the claim will be denied in full, 
but beneficiaries will continue to have all applicable administrative 
appeal rights.
    Only one prior authorization request per beneficiary per designated 
time period can be provisionally affirmed. If the initial 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 provider/
supplier indicated in the provisionally affirmed prior authorization 
request. Any provider/supplier submitting claims for repetitive 
scheduled non-emergent ambulance transports for which no prior 
authorization request is recorded will be subject to 100 percent pre-
payment medical review of those claims.
    Additional information is available on the CMS Web site at http://go.cms.gov/PAAmbulance.

III. Collection of Information Requirements

    Section 1115A(d)(3) of the Act, as added by section 3021 of the 
Affordable Care 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 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.

    Authority: Section 1115A of the Social Security Act.

    Dated: October 2, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-27030 Filed 10-22-15; 8:45 am]
BILLING CODE P



                                                  64418                         Federal Register / Vol. 80, No. 205 / Friday, October 23, 2015 / Notices

                                                  contract, or the issuance or retention of               POLICIES AND PRACTICES FOR STORING,                   SYSTEM MANAGER AND ADDRESS:
                                                  a license, grant, or other benefit, to the              RETRIEVING, ACCESSING, RETAINING AND                    Director, HSPD–12 Managed Service
                                                  extent that the information is relevant                 DISPOSING OF RECORDS IN THE SYSTEM:
                                                                                                                                                                Office, Federal Acquisition Service
                                                  and necessary to the requesting agency’s                STORAGE:                                              (FAS), General Services Administration,
                                                  decision.                                                                                                     1800 F Street NW., 4th Floor,
                                                                                                            Records are stored in electronic media              Washington, DC 20405.
                                                     h. To the Office of Management and
                                                                                                          and in paper files.
                                                  Budget (OMB) when necessary to the
                                                                                                                                                                NOTIFICATION PROCEDURE:
                                                  review of private relief legislation                    RETRIEVABILITY:
                                                  pursuant to OMB Circular No. A–19.                                                                              A request for access to records in this
                                                                                                            Records may be retrieved by name of                 system may be made by writing to the
                                                     i. To a Federal, State, or local agency,                                                                   System Manager. When requesting
                                                                                                          the individual, Cardholder Unique
                                                  or other appropriate entities or                                                                              notification of or access to records
                                                                                                          Identification Number, Applicant ID,
                                                  individuals, or through established                                                                           covered by this Notice, an individual
                                                                                                          Social Security Number, and/or by any
                                                  liaison channels to selected foreign                                                                          should provide his/her full name, date
                                                                                                          other unique individual identifier.
                                                  governments, in order to enable an                                                                            of birth, agency name, and work
                                                  intelligence agency to carry out its                    SAFEGUARDS:                                           location. An individual requesting
                                                  responsibilities under the National                                                                           notification of records must provide
                                                  Security Act of 1947, as amended; the                      Consistent with the requirements of
                                                                                                          the Federal Information Security                      identity documents sufficient to satisfy
                                                  CIA Act of 1949, as amended; Executive                                                                        the custodian of the records that the
                                                  Order 12333 or any successor order; and                 Management Act (Pub. L. 107–296), and
                                                                                                          associated OMB policies, standards and                requester is entitled to access, such as
                                                  applicable national security directives,                                                                      a government-issued photo ID.
                                                  or classified implementing procedures                   guidance from the National Institute of
                                                  approved by the Attorney General and                    Standards and Technology, and the                     RECORD ACCESS PROCEDURES:
                                                  promulgated pursuant to such statutes,                  General Services Administration, the
                                                                                                          GSA HSPD–12 managed service office                       Same as Notification Procedure above.
                                                  orders, or Directives.
                                                                                                          protects all records from unauthorized                CONTESTING RECORD PROCEDURES:
                                                     j. To designated agency personnel for                access through appropriate
                                                  controlled access to specific records for                                                                       Same as Notification Procedure above.
                                                                                                          administrative, physical, and technical               State clearly and concisely the
                                                  the purposes of performing authorized                   safeguards. Access is restricted on a
                                                  audit or authorized oversight and                                                                             information being contested, the reasons
                                                                                                          ‘‘need to know’’ basis, utilization of PIV            for contesting it, and the proposed
                                                  administrative functions. All access is                 Card access, secure VPN for Web access,
                                                  controlled systematically through                                                                             amendment to the information sought.
                                                                                                          and locks on doors and approved
                                                  authentication using PIV credentials                    storage containers. Buildings have                    RECORD SOURCE CATEGORIES:
                                                  based on access and authorization rules                 security guards and secured doors. All                  Employee, contractor, or applicant;
                                                  for specific audit and administrative                   entrances are monitored through                       sponsoring agency; former sponsoring
                                                  functions.                                              electronic surveillance equipment. The                agency; other Federal agencies; contract
                                                     k. To the Office of Personnel                        hosting facility is supported by 24/7                 employer; former employer.
                                                  Management (OPM), the Office of                         onsite hosting and network monitoring                 [FR Doc. 2015–26940 Filed 10–22–15; 8:45 am]
                                                  Management and Budget (OMB), the                        by trained technical staff. Physical                  BILLING CODE 6820–38–P
                                                  Government Accountability Office                        security controls include: Indoor and
                                                  (GAO), or other Federal agency in                       outdoor security monitoring and
                                                  accordance with the agency’s                            surveillance; badge and picture ID
                                                  responsibility for evaluation of Federal                                                                      DEPARTMENT OF HEALTH AND
                                                                                                          access screening; biometric access
                                                  personnel management.                                                                                         HUMAN SERVICES
                                                                                                          screening. Personally identifiable
                                                     l. To the Federal Bureau of                          information is safeguarded and                        Centers for Medicare & Medicaid
                                                  Investigation for the FBI National                      protected in conformance with all                     Services
                                                  Criminal History check.                                 Federal statutory and OMB guidance
                                                                                                          requirements. All access has role-based               [CMS–6063–N2]
                                                     m. To appropriate agencies, entities,
                                                  and persons when (1) the Agency                         restrictions, and individuals with access
                                                                                                                                                                Medicare Program; Expansion of Prior
                                                  suspects or has confirmed that the                      privileges have undergone vetting and
                                                                                                                                                                Authorization for Repetitive Scheduled
                                                  security or confidentiality of                          suitability screening. All data is
                                                                                                                                                                Non-Emergent Ambulance Transports
                                                  information in the system of records has                encrypted in transit. While it is not
                                                  been compromised; (2) the Agency has                    contemplated, any system records                      AGENCY: Centers for Medicare &
                                                  determined that as a result of the                      stored on mobile computers or mobile                  Medicaid Services (CMS), HHS.
                                                  suspected or confirmed compromise                       devices will be encrypted. GSA                        ACTION: Notice.
                                                  there is a risk of harm to economic or                  maintains an audit trail and performs
                                                  property interests, identity theft or                   random periodic reviews to identify                   SUMMARY:   This notice announces an
                                                  fraud, or harm to the security or                       unauthorized access. Persons given                    expansion of the 3-year Medicare Prior
                                                  integrity of this system or other systems               roles in the PIV process must be                      Authorization Model for Repetitive
                                                  or programs (whether maintained by                      approved by the Government and                        Scheduled Non-Emergent Ambulance
                                                  GSA or another agency or entity) that                   complete training specific to their roles             Transport in accordance with section
                                                                                                          to ensure they are knowledgeable about                515(a) of the Medicare Access and CHIP
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  rely upon the compromised
                                                  information; and (3) the disclosure                     how to protect personally identifiable                Reauthorization Act of 2015. The model
                                                  made to such agencies, entities, and                    information.                                          is being expanded to the states of
                                                  persons is reasonably necessary to assist                                                                     Maryland, Delaware, the District of
                                                                                                          RETENTION AND DISPOSAL:                               Columbia, North Carolina, West
                                                  in connection with GSA’s efforts to
                                                  respond to the suspected or confirmed                     Disposition of records will be                      Virginia, and Virginia.
                                                  compromise and prevent, minimize, or                    according to NARA disposition                         DATES: This expansion will begin on
                                                  remedy such harm.                                       authority N1–269–06–1 (pending).                      January 1, 2016 in Maryland, Delaware,


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                                                                                Federal Register / Vol. 80, No. 205 / Friday, October 23, 2015 / Notices                                         64419

                                                  the District of Columbia, North Carolina,               requirements, including requirements                  medical equipment and physicians’
                                                  Virginia, and West Virginia.                            relating to the origin and destination of             services, we will waive any portion of
                                                  FOR FURTHER INFORMATION CONTACT:                        the transportation, vehicle and staff, and            these sections as well as any portion of
                                                  Angela Gaston, (410) 786–7409.                          billing and reporting. Additional                     42 CFR 410.20(d), which implements
                                                    Questions regarding the Medicare                      information about Medicare coverage of                section 1869(h) of the Act, that could be
                                                  Prior Authorization Model Expansion                     ambulance services can be found in 42                 construed to limit our ability to conduct
                                                  for Repetitive Scheduled Non-Emergent                   CFR 410.40, 410.41, and in the Medicare               prior authorization. We have
                                                  Ambulance Transport should be sent to                   Benefit Policy Manual (Pub. 100–02),                  determined that the implementation of
                                                  AmbulancePA@cms.hhs.gov.                                Chapter 10, at http://www.cms.gov/                    this model does not require the waiver
                                                  SUPPLEMENTARY INFORMATION:
                                                                                                          Regulations-and-Guidance/Guidance/                    of any fraud and abuse law, including
                                                                                                          Manuals/downloads/bp102c10.pdf .                      sections 1128A, 1128B, and 1877 of the
                                                  I. Background                                              According to a study published by the              Act. Thus providers and suppliers
                                                     Medicare may cover ambulance                         Government Accountability Office in                   affected by this model must comply
                                                  services, including air ambulance                       October 2012, entitled ‘‘Costs and                    with all applicable fraud and abuse
                                                  (fixed-wing and rotary-wing) services, if               Medicare Margins Varied Widely;                       laws.
                                                  the ambulance service is furnished to a                 Transports of Beneficiaries Have
                                                                                                          Increased,’’ 4 the number of basic life               II. Provisions of the Notice
                                                  beneficiary whose medical condition is
                                                                                                          support (BLS) non-emergent transports                    In the November 14, 2014 Federal
                                                  such that other means of transportation
                                                                                                          for Medicare fee-for-service                          Register (79 FR 68271), we published a
                                                  are contraindicated. The beneficiary’s
                                                                                                          beneficiaries increased by 59 percent                 notice entitled ‘‘Medicare Program;
                                                  condition must require both the
                                                                                                          from 2004 to 2010. A similar finding                  Prior Authorization of Repetitive
                                                  ambulance transportation itself and the                                                                       Scheduled Non-emergent Ambulance
                                                  level of service provided in order for the              published by the Department of Health
                                                                                                          and Human Services’ Office of Inspector               Transports,’’ which announced the
                                                  billed service to be considered                                                                               implementation of a 3-year Medicare
                                                                                                          General in a 2006 study, entitled
                                                  medically necessary.                                                                                          Prior Authorization model that
                                                     Non-emergent transportation by                       ‘‘Medicare Payments for Ambulance
                                                                                                          Transports,’’ 5 indicated a 20-percent                established a process for seeking prior
                                                  ambulance is appropriate if either the—                                                                       authorizations for repetitive scheduled
                                                                                                          nationwide improper payment rate for
                                                  (1) beneficiary is bed-confined and it is                                                                     non-emergent ambulance transport
                                                                                                          non-emergent ambulance transport.
                                                  documented that the beneficiary’s                                                                             rendered by ambulance providers/
                                                                                                          Likewise, in June 2013, the Medicare
                                                  condition is such that other methods of                                                                       suppliers garaged in 3 states (New
                                                                                                          Payment Advisory Commission
                                                  transportation are contraindicated; or (2)                                                                    Jersey, Pennsylvania, and South
                                                                                                          published a report 6 that included an
                                                  beneficiary’s medical condition,                                                                              Carolina). These states were selected as
                                                                                                          analysis of non-emergent ambulance
                                                  regardless of bed confinement, is such                                                                        the initial states for the model because
                                                                                                          transports to dialysis facilities and
                                                  that transportation by ambulance is                                                                           of their high utilization and improper
                                                                                                          found that, during the 5-year period
                                                  medically required. Thus, bed                                                                                 payment rates for these services. The
                                                                                                          between 2007 and 2011, the volume of
                                                  confinement is not the sole criterion in                transports to and from a dialysis facility            model began on December 1, 2014, and
                                                  determining the medical necessity of                    increased 20 percent, more than twice                 will end in all 3 states on December 1,
                                                  non-emergent ambulance transportation;                  the rate of all other ambulance                       2017. Prior authorization will not apply
                                                  rather, it is one factor that is considered             transports combined.                                  to or be given for services furnished
                                                  in medical necessity determinations.1                      Section 1115A of the Social Security               after that date.
                                                     A repetitive ambulance service is                    Act (the Act) authorizes the Secretary to                Section 515(a) of the Medicare Access
                                                  defined as medically necessary                          test innovative payment and service                   and CHIP Reauthorization Act of 2015
                                                  ambulance transportation that is                        delivery models to reduce program                     (MACRA) (Pub. L. 114–10), requires
                                                  furnished in 3 or more round trips                      expenditures, while preserving or                     expansion of the previously referenced
                                                  during a 10-day period, or at least 1                   enhancing the quality of care furnished               prior authorization model to cover,
                                                  round trip per week for at least 3                      to Medicare, Medicaid, and Children’s                 effective not later than January 1, 2016,
                                                  weeks.2 Repetitive ambulance services                   Health Insurance Program beneficiaries.               states located in Medicare
                                                  are often needed by beneficiaries                          Section 1115A(d)(1) of the Act                     Administrative Contractor (MAC)
                                                  receiving dialysis or cancer treatment.                 authorizes the Secretary to waive such                regions L and 11 (consisting of
                                                     Medicare may cover repetitive,                       requirements of Titles XI and XVIII and               Delaware, the District of Columbia,
                                                  scheduled, non-emergent transportation                  of sections 1902(a)(1), 1902(a)(13), and              Maryland, New Jersey, Pennsylvania,
                                                  by ambulance if the—(1) medical                         1903(m)(2)(A)(iii) of the Act as may be               North Carolina, South Carolina, West
                                                  necessity requirements described                        necessary solely for purposes of carrying             Virginia, and Virginia). As such, in
                                                  previously are met; and (2) ambulance                   out section 1115A of the Act with                     accordance with section 515(a) of
                                                  provider/supplier, before furnishing the                respect to testing models described in                MACRA, our initial expansion of the
                                                  service to the beneficiary, obtains a                   section 1115A(b) of the Act. For these                prior authorization model for repetitive
                                                  written order from the beneficiary’s                    models, consistent with this standard,                scheduled non-emergent ambulance
                                                  attending physician certifying that the                 we will waive such provisions of                      transport will include six additional
                                                  medical necessity requirements are met                  sections 1834(a)(15) and 1869(h) of the               states: Delaware, the District of
                                                  (see 42 CFR 410.40(d)(1) and (2)).3                     Act that limit our ability to conduct                 Columbia, Maryland, North Carolina,
                                                     In addition to the medical necessity                 prior authorization. While these                      Virginia, and West Virginia. This
                                                  requirements, the service must meet all
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                                                                                                          provisions are specific to durable                    expansion will begin on January 1,
                                                  other Medicare coverage and payment                                                                           2016. The model will end in all states
                                                                                                            4 Government Accountability Office Cost and
                                                                                                                                                                on December 1, 2017. Prior
                                                    1 42 CFR 410.40(d)(1).                                Medicare Margins Varied Widely; Transports of         authorization will not apply to or be
                                                    2 Program Memorandum Intermediaries/Carriers,         Beneficiaries Have Increased (October 2012).
                                                  Transmittal AB–03–106.                                    5 Office of Inspector General Medicare Payment
                                                                                                                                                                given for services furnished after that
                                                    3 Per 42 CFR 410.40(d)(2), the physician’s order      for Ambulance Transport (January 2006).               date.
                                                  must be dated no earlier than 60 days before the          6 Medicare Payment Advisory Commission, June           We will continue to test whether prior
                                                  date the service is furnished.                          2013, pages 167–193.                                  authorization helps reduce


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                                                  64420                         Federal Register / Vol. 80, No. 205 / Friday, October 23, 2015 / Notices

                                                  expenditures, while maintaining or                      However, if prior authorization has not                 The following describes examples of
                                                  improving quality of care, using the                    been requested by the fourth round trip               various prior authorization scenarios:
                                                  established prior authorization process                 in a 30-day period, the claims will be                  • Scenario 1: When an ambulance
                                                  for repetitive scheduled non-emergent                   stopped for pre-payment review.                       provider/supplier or beneficiary submits
                                                  ambulance transport to reduce                              In order to be provisionally affirmed,             a prior authorization request to the MAC
                                                  utilization of services that do not                     the request for prior authorization must              with appropriate documentation and all
                                                  comply with Medicare policy.                            meet all applicable rules and policies,               relevant Medicare coverage and
                                                     We will continue to use this prior                   and any local coverage determination                  documentation requirements are met for
                                                  authorization process to help ensure                    (LCD) requirements for ambulance                      the ambulance transport, the MAC will
                                                  that all relevant clinical or medical                   transport claims. A provisional                       send a provisional affirmative prior
                                                  documentation requirements are met                      affirmation is a preliminary finding that             authorization decision to the ambulance
                                                  before services are furnished to                        a future claim submitted to Medicare for              provider/supplier and to the
                                                  beneficiaries and before claims are                     the service likely meets Medicare’s                   beneficiary. When the claim is
                                                  submitted for payment. This prior                       coverage, coding, and payment                         submitted to the MAC by the ambulance
                                                  authorization process further helps to                  requirements. After receipt of all                    provider/supplier, it is linked to the
                                                  ensure that payment complies with                       relevant documentation, the MACs will                 prior authorization via the claims
                                                  Medicare documentation, coverage,                       make every effort to conduct a review                 processing system and the claim will be
                                                  payment, and coding rules.                              and postmark the notification of their                paid so long as all Medicare coding,
                                                     The use of prior authorization does                  decision on a prior authorization                     billing, and coverage requirements are
                                                  not create new clinical documentation                   request within 10 business days for an                met. However, after submission, the
                                                  requirements. Instead, it requires the                  initial submission. Notification will be              claim could be denied for technical
                                                  same information that is already                        provided to the ambulance provider/                   reasons, such as the claim was a
                                                  required to support Medicare payment,                   supplier and to the beneficiary. If a                 duplicate claim or the claim was for a
                                                  just earlier in the process. Prior                      subsequent prior authorization request                deceased beneficiary. In addition, a
                                                  authorization allows providers and                      is submitted after a non-affirmative                  claim denial could occur because
                                                  suppliers to address coverage issues                    decision on an initial prior                          certain documentation, such as the trip
                                                  prior to furnishing services.                           authorization request, the MACs will                  record, needed in support of the claim
                                                     The prior authorization process under                                                                      cannot be reviewed on a prior
                                                                                                          make every effort to conduct a review
                                                  this model will apply in the additional                                                                       authorization request.
                                                                                                          and postmark the notification of their
                                                  six states listed previously for the                                                                            • Scenario 2: When an ambulance
                                                                                                          decision on the request within 20
                                                  following codes for Medicare payment:                                                                         provider/supplier or beneficiary submits
                                                                                                          business days.
                                                     • A0426 Ambulance service,                                                                                 a prior authorization request, but all
                                                  advanced life support, non-emergency                       An ambulance provider/supplier or                  relevant Medicare coverage
                                                  transport, Level 1 (ALS1).                              beneficiary may request an expedited                  requirements are not met, the MAC will
                                                     • A0428 Ambulance service, BLS,                      review when the standard timeframe for                send a non-affirmative prior
                                                  non-emergency transport.                                making a prior authorization decision                 authorization decision to the ambulance
                                                     While prior authorization in the                     could jeopardize the life or health of the            provider/supplier and to the
                                                  additional six states is not needed for                 beneficiary. If the MAC agrees that the               beneficiary, advising them that
                                                  the mileage code, A0425, a prior                        standard review timeframe would put                   Medicare will not pay for the service.
                                                  authorization decision for an A0426 or                  the beneficiary at risk, the MAC will                 The provider/supplier or beneficiary
                                                  A0428 code will automatically include                   make reasonable efforts to communicate                may then resubmit the request with
                                                  the associated mileage code.                            a decision within 2 business days of                  documentation showing that Medicare
                                                     Prior to the start of the expansion, we              receipt of all applicable Medicare-                   requirements have been met.
                                                  will conduct (and thereafter will                       required documentation. As this model                 Alternatively, an ambulance provider/
                                                  continue to conduct) outreach and                       is for non-emergent services only, we                 supplier could furnish the service, and
                                                  education to ambulance providers/                       expect requests for expedited reviews to              submit a claim with a non-affirmative
                                                  suppliers, as well as beneficiaries,                    be extremely rare.                                    prior authorization tracking number, at
                                                  through such methods as the issuance of                    A provisional affirmative prior                    which point the MAC would deny the
                                                  an operational guide, frequently asked                  authorization decision may affirm a                   claim. The ambulance provider/supplier
                                                  questions (FAQs) on our Web site, a                     specified number of trips within a                    and the beneficiary would then have the
                                                  beneficiary mailing, a physician letter                 specific amount of time. The prior                    Medicare denial for secondary
                                                  explaining the ambulance providers/                     authorization decision, justified by the              insurance purposes and would have the
                                                  suppliers’ need for the proper                          beneficiary’s condition, may affirm up                opportunity to submit an appeal of the
                                                  documentation, and educational events                   to 40 round trips (which equates to 80                claim denial if they believe Medicare
                                                  and materials issued by the MACs.                       one-way trips) per prior authorization                coverage was denied inappropriately.
                                                  Additional information about the                        request in a 60-day period.                             • Scenario 3: When an ambulance
                                                  implementation of the prior                             Alternatively, a provisional affirmative              provider/supplier or beneficiary submits
                                                  authorization model is available on the                 prior authorization decision may affirm               a prior authorization request with
                                                  CMS Web site at http://go.cms.gov/                      less than 40 round trips in a 60-day                  incomplete documentation, a detailed
                                                  PAAmbulance.                                            period, or may affirm a request that                  decision letter will be sent to the
                                                     Under this model, an ambulance                       seeks to provide a specified number of                ambulance provider/supplier and to the
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                                                  provider/supplier or beneficiary is                     transports (40 round trips or less) in less           beneficiary, with an explanation of what
                                                  encouraged to submit to the MAC a                       than a 60-day period. A provisional                   information is missing. The ambulance
                                                  request for prior authorization along                   affirmative decision can be for all or                provider/supplier or beneficiary can
                                                  with all relevant documentation to                      part of the requested number of trips.                rectify the situation and resubmit the
                                                  support Medicare coverage of a                          Transports exceeding 40 round trips (or               prior authorization request with
                                                  repetitive scheduled non-emergent                       80 one-way trips) in a 60-day period                  appropriate documentation.
                                                  ambulance transport. Submitting a prior                 require an additional prior authorization               • Scenario 4: When an ambulance
                                                  authorization request is voluntary.                     request.                                              provider or supplier renders a service to


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                                                                                Federal Register / Vol. 80, No. 205 / Friday, October 23, 2015 / Notices                                               64421

                                                  a beneficiary that is subject to the prior              need not be reviewed by the Office of                 OMB control number 0910–0291. The
                                                  authorization process, and the claim is                 Management and Budget under the                       approval expires on September 30,
                                                  submitted to the MAC for payment                        authority of the Paperwork Reduction                  2018. A copy of the supporting
                                                  without requesting a prior                              Act of 1995.                                          statement for this information collection
                                                  authorization, the claim will be stopped                                                                      is available on the Internet at http://
                                                                                                          IV. Regulatory Impact Statement
                                                  for prepayment review and                                                                                     www.reginfo.gov/public/do/PRAMain.
                                                  documentation will be requested.                          This document announces an
                                                                                                                                                                  Dated: October 15, 2015.
                                                     ++ If the claim is determined not to                 expansion of the 3-year Medicare Prior
                                                  be medically necessary or to be                         Authorization Model for Repetitive                    Leslie Kux,
                                                  insufficiently documented, the claim                    Scheduled Non-Emergent Ambulance                      Associate Commissioner for Policy.
                                                  will be denied, and all current policies                Transport. Therefore, there are no                    [FR Doc. 2015–26923 Filed 10–22–15; 8:45 am]
                                                  and procedures regarding liability for                  regulatory impact implications                        BILLING CODE 4164–01–P
                                                  payment will apply. The ambulance                       associated with this notice.
                                                  provider/supplier or the beneficiary or                   Authority: Section 1115A of the Social
                                                  both can appeal the claim denial if they                Security Act.                                         DEPARTMENT OF HEALTH AND
                                                  believe the denial was inappropriate.                                                                         HUMAN SERVICES
                                                     ++ If the claim is determined to be                    Dated: October 2, 2015.
                                                  payable, it will be paid.                               Andrew M. Slavitt,                                    Food and Drug Administration
                                                     Under the model, we will work to                     Acting Administrator, Centers for Medicare
                                                  limit any adverse impact on                             & Medicaid Services.                                  [Docket No. FDA–2014–N–1048]
                                                  beneficiaries and to educate                            [FR Doc. 2015–27030 Filed 10–22–15; 8:45 am]
                                                  beneficiaries about the process. If a prior             BILLING CODE P                                        Agency Information Collection
                                                  authorization request is not affirmed,                                                                        Activities; Announcement of Office of
                                                  and the claim is still submitted by the                                                                       Management and Budget Approval;
                                                  provider/supplier, the claim will be                    DEPARTMENT OF HEALTH AND                              Medical Device Labeling Regulations
                                                  denied in full, but beneficiaries will                  HUMAN SERVICES
                                                  continue to have all applicable                                                                               AGENCY:    Food and Drug Administration,
                                                  administrative appeal rights.                           Food and Drug Administration                          HHS.
                                                     Only one prior authorization request                 [Docket No. FDA–2014–N–1960]
                                                  per beneficiary per designated time                                                                           ACTION:   Notice.
                                                  period can be provisionally affirmed. If                Agency Information Collection
                                                  the initial provider/supplier cannot                    Activities; Announcement of Office of                 SUMMARY:   The Food and Drug
                                                  complete the total number of prior                      Management and Budget Approval;                       Administration (FDA) is announcing
                                                  authorized transports (for example, the                 MedWatch: The Food and Drug                           that a collection of information entitled
                                                  initial ambulance company closes or no                  Administration Medical Products                       ‘‘Medical Device Labeling Regulations’’
                                                  longer services that area), the initial                 Reporting Program                                     has been approved by the Office of
                                                  request is cancelled. In this situation, a                                                                    Management and Budget (OMB) under
                                                                                                          AGENCY:    Food and Drug Administration,              the Paperwork Reduction Act of 1995.
                                                  subsequent prior authorization request
                                                                                                          HHS.
                                                  may be submitted for the same                                                                                 FOR FURTHER INFORMATION CONTACT:    FDA
                                                  beneficiary and must include the                        ACTION:   Notice.
                                                                                                                                                                PRA Staff, Office of Operations, Food
                                                  required documentation in the                           SUMMARY:    The Food and Drug                         and Drug Administration, 8455
                                                  submission. If multiple ambulance                       Administration (FDA) is announcing                    Colesville Rd., COLE–14526, Silver
                                                  providers/suppliers are providing                       that a collection of information entitled             Spring, MD 20993–0002, PRAStaff@
                                                  transports to the beneficiary during the                ‘‘MedWatch: The Food and Drug                         fda.hhs.gov.
                                                  same or overlapping time period, the                    Administration Medical Products
                                                  prior authorization decision will only                  Reporting Program’’ has been approved                 SUPPLEMENTARY INFORMATION:      On
                                                  cover the provider/supplier indicated in                by the Office of Management and                       January 30, 2015, the Agency submitted
                                                  the provisionally affirmed prior                        Budget (OMB) under the Paperwork                      a proposed collection of information
                                                  authorization request. Any provider/                    Reduction Act of 1995.                                entitled ‘‘Medical Device Labeling
                                                  supplier submitting claims for repetitive                                                                     Regulations’’ to OMB for review and
                                                                                                          FOR FURTHER INFORMATION CONTACT: FDA
                                                  scheduled non-emergent ambulance                                                                              clearance under 44 U.S.C. 3507. An
                                                                                                          PRA Staff, Office of Operations, Food
                                                  transports for which no prior                                                                                 Agency may not conduct or sponsor,
                                                                                                          and Drug Administration, 8455
                                                  authorization request is recorded will be                                                                     and a person is not required to respond
                                                                                                          Colesville Rd., COLE–14526, Silver
                                                  subject to 100 percent pre-payment                                                                            to, a collection of information unless it
                                                                                                          Spring, MD 20993–0002, PRAStaff@
                                                  medical review of those claims.                                                                               displays a currently valid OMB control
                                                                                                          fda.hhs.gov.
                                                     Additional information is available on                                                                     number. OMB has now approved the
                                                  the CMS Web site at http://go.cms.gov/                  SUPPLEMENTARY INFORMATION: On June                    information collection and has assigned
                                                  PAAmbulance.                                            11, 2015, the Agency submitted a                      OMB control number 0910–0485. The
                                                                                                          proposed collection of information                    approval expires on September 30,
                                                  III. Collection of Information                          entitled ‘‘MedWatch: The Food and                     2018. A copy of the supporting
                                                  Requirements                                            Drug Administration Medical Products                  statement for this information collection
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                                                     Section 1115A(d)(3) of the Act, as                   Reporting Program’’ to OMB for review                 is available on the Internet at http://
                                                  added by section 3021 of the Affordable                 and clearance under 44 U.S.C. 3507. An                www.reginfo.gov/public/do/PRAMain.
                                                  Care Act, states that chapter 35 of title               Agency may not conduct or sponsor,
                                                                                                                                                                  Dated: October 16, 2015.
                                                  44, United States Code (the Paperwork                   and a person is not required to respond
                                                  Reduction Act of 1995), shall not apply                 to, a collection of information unless it             Leslie Kux,
                                                  to the testing and evaluation of models                 displays a currently valid OMB control                Associate Commissioner for Policy.
                                                  or expansion of such models under this                  number. OMB has now approved the                      [FR Doc. 2015–26986 Filed 10–22–15; 8:45 am]
                                                  section. Consequently, this document                    information collection and has assigned               BILLING CODE 4164–01–P




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Document Created: 2015-12-14 15:32:49
Document Modified: 2015-12-14 15:32:49
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThis expansion will begin on January 1, 2016 in Maryland, Delaware, the District of Columbia, North Carolina, Virginia, and West Virginia.
ContactAngela Gaston, (410) 786-7409.
FR Citation80 FR 64418 

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