Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 68271 

1 42 CFR 410.40(d)(1). 

2Program Memorandum Intermediaries/Carriers, 

Transmittal AB–03–106. 

3Per 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. 

4Medicare Payment Advisory Commission, June 

2013, pages 167–193. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–6063–N] 

Medicare Program; Prior Authorization 

of Repetitive Scheduled Nonemergent 

Ambulance Transports 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces a 3- 

year Medicare Prior Authorization 

model for repetitive scheduled 

nonemergent ambulance transport in the 

states of New Jersey, Pennsylvania, and 

South Carolina where there have been 

high incidences of improper payments 

for these services. 

DATES: This model will begin on 

December 1, 2014 in South Carolina, 

New Jersey, and Pennsylvania. 

FOR FURTHER INFORMATION CONTACT: 

Angela Gaston, (410) 786–7409. 

Questions regarding the Medicare Prior 

Authorization Model for Repetitive 

Scheduled Nonemergent Ambulance 

Transport should be sent to 

AmbulancePA@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Medicare covers ambulance services, 

including air ambulance (fixed wing 

and rotary wing) services, when 

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. 

Nonemergent transportation by 

ambulance is appropriate if either—(1) 

the beneficiary is bed-confined and it is 

documented that the beneficiary’s 

condition is such that other methods of 

transportation are contraindicated; or (2) 

the 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 

nonemergent ambulance transportation; 

rather, it is one factor that is considered 

in medical necessity determinations.1

A repetitive ambulance service is 

defined as medically necessary 

ambulance transportation that is 

furnished in 3 round trips or more times 

during a 10-day period, or at least once 

per week for at least 3 weeks.2

Repetitive ambulance services are often 

needed by beneficiaries receiving 

dialysis, wound care, or cancer 

treatment. 

Medicare may cover repetitive, 

scheduled, nonemergent transportation 

by ambulance if—(1) the medical 

necessity requirements described 

previously are met; and (2) the 

ambulance provider/supplier, before 

furnishing the service to the beneficiary, 

obtains a written order from the 

beneficiary’s attending physician 

certifying that the medical necessity 

requirements are met (see 42 CFR 

410.40(d)(1) and (2)).3

In addition to the medical necessity 

requirements, the service must meet all 

other Medicare coverage and payment 

requirements, including requirements 

relating to the origin and destination of 

the transportation, vehicle and staff, and 

billing and reporting. Additional 

information about Medicare coverage of 

ambulance services can be found in 42 

CFR 410.40, 410.41, and in the Medicare 

Benefit Policy Manual, Chapter 10, at 

http://www.cms.gov/Regulations-andGuidance/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’’, the number of Basic Life 

Support (BLS) nonemergent 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’’, indicated a 20 percent 

nationwide improper payment rate for 

nonemergent ambulance transport. 

Likewise, in June 2013, the Medicare 

Payment Advisory Commission 

published a report 4 that included an 

analysis of nonemergent ambulance 

transports to dialysis facilities and 

found that, during the 5-year period 

between 2007 and 2011, the volume of 

transports to and from a dialysis facility 

increased 20 percent, more than twice 

the rate of all other ambulance 

transports combined. 

Section 1115A of the 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 physician 

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 

We plan to implement a 3-year 

Medicare Prior Authorization process 

for repetitive scheduled nonemergent 

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 will begin in on 

December 1, 2014, in South Carolina, 

New Jersey, and Pennsylvania. 

We plan to test whether prior 

authorization helps reduce 

expenditures, while maintaining or 

improving quality of care, using a model 

that would establish a prior 

authorization process for repetitive 

scheduled nonemergent ambulance 

transport to reduce utilization of 

services that do not comply with 

Medicare policy. 

We plan to use this prior 

authorization process to ensure that all 

relevant clinical or medical 

documentation requirements are met 

before services are rendered to 

beneficiaries and before claims are 

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68272 Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 

submitted for payment. This prior 

authorization process will further 

ensure that payment complies with 

Medicare documentation, coverage, 

payment, and coding rules. 

The use of prior authorization will not 

create new clinical documentation 

requirements. Instead, it will require the 

same information that is already 

required to support Medicare payment, 

just earlier in the process. Prior 

authorization allows providers and 

suppliers to address issues with claims 

prior to rendering services. 

The prior authorization process under 

this model will be available for the 

following codes for Medicare payment: 

• A0425 Ambulance service, basic 

life support (BLS)/advanced life support 

(ALS) ground mileage (per statute mile). 

• A0426 Ambulance service, 

advanced life support, nonemergency 

transport, Level 1 (ALS1). 

• A0428 Ambulance service, basic 

life support (BLS), nonemergency 

transport. 

Prior to the start of the model, we will 

conduct (and thereafter will continue to 

conduct) outreach and education to 

ambulance providers/suppliers, as well 

as beneficiaries, through such methods 

as open door forums, frequently asked 

questions (FAQs) on our Web site, other 

Web site postings, and educational 

materials issued by the Medicare 

Administrative Contractors (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 will be 

encouraged to submit to the MAC a 

request for prior authorization along 

with all relevant documentation to 

support Medicare coverage of a 

repetitive scheduled nonemergent 

ambulance transport. Submitting a prior 

authorization request will be voluntary. 

(However, if prior authorization has not 

been requested before 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 nonaffirmative 

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 Medicarerequired documentation. As this model 

is for nonemergent 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 

will 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 since 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 nonaffirmative 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 render the service, and 

submit a claim with a nonaffirmative 

prior authorization tracking number, at 

which point the MAC would deny the 

claim. The ambulance provider/supplier 

and/or 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 

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 to be 

not 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 

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Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 68273 

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 nonemergent ambulance 

transports for which no prior 

authorization request is recorded will be 

subject to 100 percent prepayment 

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 (44 U.S.C. 35). 

Authority: Section 1115A of the Social 

Security Act. 

Dated: October 8, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–26987 Filed 11–13–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0279] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Prescription Drug 

Marketing Act of 1987; Administrative 

Procedures, Policies, and 

Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection in the 

regulations on the Prescription Drug 

Marketing Act of 1987; Administrative 

Procedures, Policies, and Requirements. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 13, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA 305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Prescription Drug Marketing Act of 

1987; Administrative Procedures, 

Policies, and Requirements—21 CFR 

Part 203—(OMB Control Number 0910– 

0435)—Extension 

FDA is requesting OMB approval 

under the PRA (44 U.S.C. 3501–3520) 

for the reporting and recordkeeping 

requirements contained in the 

regulations implementing the 

Prescription Drug Marketing Act of 1987 

(PDMA). PDMA was intended to ensure 

that drug products purchased by 

consumers are safe and effective and to 

avoid an unacceptable risk that 

counterfeit, adulterated, misbranded, 

subpotent, or expired drugs are sold. 

PDMA was enacted by Congress 

because there were insufficient 

safeguards in the drug distribution 

system to prevent the introduction and 

retail sale of substandard, ineffective, or 

counterfeit drugs, and that a wholesale 

drug diversion submarket had 

developed that prevented effective 

control over the true sources of drugs. 

Congress found that large amounts of 

drugs had been reimported into the 

United States as U.S. goods returned 

causing a health and safety risk to U.S. 

consumers because the drugs may 

become subpotent or adulterated during 

foreign handling and shipping. Congress 

also found that a ready market for 

prescription drug reimports had been 

the catalyst for a continuing series of 

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