69490 Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 

authorization request (and, upon 

request, to the beneficiary if he or she 

was not the original submitter). 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. 

A facility 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 a 

non-emergent service only, we expect 

requests for expedited reviews to be 

extremely rare. 

The following describes examples of 

various prior authorization scenarios: 

• Scenario 1: When a facility 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 HBO therapy, the MAC will send a 

provisional affirmative prior 

authorization decision to the submitter 

(and, upon request, to the beneficiary if 

he or she was not the original 

submitter). When the claim is submitted 

to the MAC, it is linked to the prior 

authorization via the claims processing 

system and the claim is 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 being a duplicate 

claim or being for a date of service after 

a beneficiary’s death. 

• Scenario 2: When a facility 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 submitter (and, upon request, to 

the beneficiary if he or she was not the 

original submitter), advising them that 

Medicare will not pay for the service. 

The facility or beneficiary may then 

resubmit the request with 

documentation showing that Medicare 

requirements have been met. 

Alternatively, a facility 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 facility 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 a facility or 

beneficiary submits a prior 

authorization request with incomplete 

documentation, a detailed decision 

letter will be sent to the submitter (and, 

upon request, to the beneficiary if he or 

she was not the original submitter) with 

an explanation of what information is 

missing. The facility or beneficiary can 

rectify the situation and resubmit the 

prior authorization request with 

appropriate documentation. 

• Scenario 4: When a facility renders 

a service that is subject to the prior 

authorization process to a beneficiary, 

and submits the claim 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 facility and/or 

beneficiary 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 

facility, 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 facility cannot complete the 

total number of HBO treatments (for 

example, the initial facility closes or the 

beneficiary moves out of the 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 facilities are 

providing HBO treatments to the 

beneficiary during the same or 

overlapping time period, the prior 

authorization decision will only cover 

the facility indicated in the 

provisionally affirmed prior 

authorization request. Any facility 

submitting claims 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/ 

PAHBO. 

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. 2014–27578 Filed 11–20–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1464–N] 

Medicare Program; Town Hall Meeting 

on FY 2016 Applications for New 

Medical Services and Technology AddOn Payments 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces a 

Town Hall meeting in accordance with 

section 1886(d)(5)(K)(viii) of the Social 

Security Act (the Act) to discuss fiscal 

year (FY) 2016 applications for add-on 

payments for new medical services and 

technologies under the hospital 

inpatient prospective payment systems 

(IPPS). Interested parties are invited to 

this meeting to present their comments, 

recommendations, and data regarding 

whether the FY 2016 new medical 

services and technologies applications 

meet the substantial clinical 

improvement criterion. 

DATES: Meeting Date: The Town Hall 

Meeting announced in this notice will 

be held on Tuesday, February 3, 2015. 

The Town Hall Meeting will begin at 

9:00 a.m. Eastern Standard Time (e.s.t.) 

and check-in will begin at 8:30 a.m. 

e.s.t. 

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Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 69491 

Deadline for Registration for 

Participants (not Presenting) at the 

Town Hall Meeting and Submitting 

Requests for Special Accommodations: 

Registration to attend the Town Hall 

Meeting and requests for special 

accommodations must be received no 

later than 5:00 p.m. Tuesday, January 

20, 2015. 

Deadline for Registration of Presenters 

at the Town Hall Meeting: Registration 

to present at the Town Hall Meeting 

must be received no later than 5:00 p.m. 

e.s.t. on Monday, January 19, 2015. 

Deadline for Submission of Agenda 

Item(s) or Written Comments for the 

Town Hall Meeting: Written comments 

and agenda items for discussion at the 

Town Hall Meeting, including agenda 

items by presenters, must be received no 

later than 5:00 p.m. e.s.t. Monday, 

January 19, 2015. In addition to 

materials submitted for discussion at the 

Town Hall Meeting, individuals may 

submit other written comments after the 

Town Hall Meeting, as specified in the 

ADDRESSES section of this notice, on 

whether the service or technology 

represents a substantial clinical 

improvement. These comments must be 

received no later than 5:00 p.m. e.s.t on 

Tuesday, February 24, 2015, for 

consideration in the FY 2016 IPPS 

proposed rule. 

ADDRESSES: Meeting Location: The 

Town Hall Meeting will be held in the 

main Auditorium in the central building 

of the Centers for Medicare and 

Medicaid Services located at 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

In addition, we are providing two 

alternatives to attending the meeting in 

person—(1) there will be an open tollfree phone line to call into the Town 

Hall Meeting; or (2) participants may 

view and participate in the Town Hall 

Meeting via live stream technology and/ 

or webinar. Information on these 

options is provided in section II.B. of 

this notice. 

Registration and Special 

Accommodations: Individuals wishing 

to participate in the meeting must 

register by following the on-line 

registration instructions located in 

section III. of this notice or by 

contacting staff listed in the FOR

FURTHER INFORMATION CONTACT section of 

this notice. Individuals who need 

special accommodations should contact 

staff listed in the FOR FURTHER

INFORMATION CONTACT section of this 

notice. 

Submission of Agenda Item(s) or 

Written Comments for the Town Hall 

Meeting: Each presenter must submit an 

agenda item(s) regarding whether a FY 

2016 application meets the substantial 

clinical improvement criterion. Agenda 

items, written comments, questions or 

other statements must not exceed three 

single-spaced typed pages and may be 

sent via email to newtech@cms.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Michael Treitel, (410) 786–4552, 

michael.treitel@cms.hhs.gov, or Celeste 

Beauregard, (410) 786–8102, 

celeste.beauregard@cms.hhs.gov. 

Alternatively, you may forward your 

requests via email to newtech@

cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background on the Add-On Payments 

for New Medical Services and 

Technologies Under the IPPS 

Sections 1886(d)(5)(K) and (L) of the 

Social Security Act (the Act) require the 

Secretary to establish a process of 

identifying and ensuring adequate 

payments to acute care hospitals for 

new medical services and technologies 

under Medicare. Effective for discharges 

beginning on or after October 1, 2001, 

section 1886(d)(5)(K)(i) of the Act 

requires the Secretary to establish (after 

notice and opportunity for public 

comment) a mechanism to recognize the 

costs of new services and technologies 

under the hospital inpatient prospective 

payment system (IPPS). In addition, 

section 1886(d)(5)(K)(vi) of the Act 

specifies that a medical service or 

technology will be considered ‘‘new’’ if 

it meets criteria established by the 

Secretary (after notice and opportunity 

for public comment). (See the FY 2002 

IPPS proposed rule (66 FR 22693, May 

4, 2001) and final rule (66 FR 46912, 

September 7, 2001) for a more detailed 

discussion.) 

In the September 7, 2001 final rule (66 

FR 46914), we noted that we evaluated 

a request for special payment for a new 

medical service or technology against 

the following criteria in order to 

determine if the new technology meets 

the substantial clinical improvement 

requirement: 

• The device offers a treatment option 

for a patient population unresponsive 

to, or ineligible for, currently available 

treatments. 

• The device offers the ability to 

diagnose a medical condition in a 

patient population where that medical 

condition is currently undetectable or 

offers the ability to diagnose a medical 

condition earlier in a patient population 

than allowed by currently available 

methods. There must also be evidence 

that use of the device to make a 

diagnosis affects the management of the 

patient. 

• Use of the device significantly 

improves clinical outcomes for a patient 

population as compared to currently 

available treatments. Some examples of 

outcomes that are frequently evaluated 

in studies of medical devices are the 

following: 

++ Reduced mortality rate with use of 

the device. 

++ Reduced rate of device-related 

complications. 

++ Decreased rate of subsequent 

diagnostic or therapeutic interventions 

(for example, due to reduced rate of 

recurrence of the disease process). 

++ Decreased number of future 

hospitalizations or physician visits. 

++ More rapid beneficial resolution 

of the disease process treatment because 

of the use of the device. 

++ Decreased pain, bleeding or other 

quantifiable symptoms. 

++ Reduced recovery time. 

In addition, we indicated that the 

requester is required to submit evidence 

that the technology meets one or more 

of these criteria. 

Section 503 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) 

amended section 1886(d)(5)(K)(viii) of 

the Act to revise the process for 

evaluating new medical services and 

technology applications by requiring the 

Secretary to do the following: 

• Provide for public input regarding 

whether a new service or technology 

represents an advance in medical 

technology that substantially improves 

the diagnosis or treatment of Medicare 

beneficiaries before publication of a 

proposed rule. 

• Make public and periodically 

update a list of all the services and 

technologies for which an application is 

pending. 

• Accept comments, 

recommendations, and data from the 

public regarding whether the service or 

technology represents a substantial 

improvement. 

• Provide for a meeting at which 

organizations representing hospitals, 

physicians, manufacturers and any 

other interested party may present 

comments, recommendations, and data 

to the clinical staff of CMS as to whether 

the service or technology represents a 

substantial improvement before 

publication of a proposed rule. 

The opinions and recommendations 

provided during this meeting will assist 

us as we evaluate the new medical 

services and technology applications for 

fiscal year (FY) 2016. In addition, they 

will help us to evaluate our policy on 

the IPPS new technology add-on 

payment process before the publication 

of the FY 2016 IPPS proposed rule. 

mstockstill on DSK4VPTVN1PROD with NOTICES

69492 Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 

II. Town Hall Meeting and Conference 

Calling/Live Streaming Information 

A. Format of the Town Hall Meeting 

As noted in section I. of this notice, 

we are required to provide for a meeting 

at which organizations representing 

hospitals, physicians, manufacturers 

and any other interested party may 

present comments, recommendations, 

and data to the clinical staff of CMS 

concerning whether the service or 

technology represents a substantial 

clinical improvement. This meeting will 

allow for a discussion of the substantial 

clinical improvement criteria for each of 

the FY 2016 new medical services and 

technology add-on payment 

applications. Information regarding the 

applications can be found on our Web 

site at http://www.cms.gov/Medicare/

Medicare-Fee-for-Service-Payment/

AcuteInpatientPPS/newtech.html. 

The majority of the meeting will be 

reserved for presentations of comments, 

recommendations, and data from 

registered presenters. The time for each 

presenter’s comments will be 

approximately 10 to 15 minutes and 

will be based on the number of 

registered presenters. Presenters will be 

scheduled to speak in the order in 

which they register and grouped by new 

technology applicant. Therefore, 

individuals who would like to present 

must register and submit their agenda 

item(s) via email to newtech@

cms.hhs.gov by the date specified in the 

DATES section of this notice. 

In addition, written comments will 

also be accepted and presented at the 

meeting if they are received via email to 

newtech@cms.hhs.gov by the date 

specified in the DATES section of this 

notice. Written comments may also be 

submitted after the meeting for our 

consideration. If the comments are to be 

considered before the publication of the 

proposed rule, the comments must be 

received via email to newtech@

cms.hhs.gov by the date specified in the 

DATES section of this notice. 

B. Conference Call, Live Streaming, and 

Webinar Information 

For participants who cannot attend 

the Town Hall Meeting in person, an 

open toll-free phone line, (877) 267– 

1577, has been made available. The 

Meeting Place meeting ID is 993 601 

192. 

Also, there will be an option to view 

and participate in the Town Hall 

Meeting via live streaming technology 

and/or a webinar. Information on the 

option to participate via live streaming 

technology and/or a webinar will be 

provided through an upcoming listserv 

notice and posted on the New 

Technology Web site at http://

www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/

AcuteInpatientPPS/newtech.html. 

Continue to check the Web site for 

updates. 

Disclaimer: We cannot guarantee the 

reliability of live streaming technology 

and/or a webinar. 

III. Registration Instructions 

The Division of Acute Care in CMS is 

coordinating the meeting registration for 

the Town Hall Meeting for the FY 2016 

Applications for New Medical Services 

and Technology Add-On Payments on 

substantial clinical improvement. While 

there is no registration fee, individuals 

planning to attend the Town Hall 

Meeting in person must register to 

attend. 

Registration may be completed online at the following web address: 

http://www.cms.gov/Medicare/

Medicare-Fee-for-Service-Payment/

AcuteInpatientPPS/newtech.html. 

Select the link at the bottom of the page 

‘‘Register to Attend the New Technology 

Town Hall Meeting’’. After completing 

the registration, on-line registrants 

should print the confirmation page(s) 

and bring it with them to the meeting(s). 

If you are unable to register on-line, 

you may register by sending an email to 

newtech@cms.hhs.gov. Please include 

your name, address, telephone number, 

email address, and fax number. If 

seating capacity has been reached, you 

will be notified that the meeting has 

reached capacity. 

IV. Security, Building, and Parking 

Guidelines 

Because this meeting will be located 

on Federal property, for security 

reasons, any persons wishing to attend 

this meeting must register by the date 

specified in the DATES section of this 

notice. Please allow sufficient time to go 

through the security checkpoints. It is 

suggested that you arrive at 7500 

Security Boulevard no later than 8:30 

a.m. e.s.t. 

Security measures include the 

following: 

• Presentation of government-issued 

photographic identification to the 

Federal Protective Service or Guard 

Service personnel. 

• Interior and exterior inspection of 

vehicles (this includes engine and trunk 

inspection) at the entrance to the 

grounds. Parking permits and 

instructions will be issued after the 

vehicle inspection. 

• Passing through a metal detector 

and inspection of items brought into the 

building. We note that all items brought 

to CMS, whether personal or for the 

purpose of demonstration or to support 

a demonstration, are subject to 

inspection. We cannot assume 

responsibility for coordinating the 

receipt, transfer, transport, storage, setup, safety, or timely arrival of any 

personal belongings or items used for 

demonstration or to support a 

demonstration. 

Note: Individuals who are not registered in 

advance will not be permitted to enter the 

building and will be unable to attend the 

meeting in person. The public may not enter 

the building earlier than 45 minutes prior to 

the convening of the meeting(s). 

All visitors must be escorted in areas 

other than the lower and first floor 

levels in the Central Building. Seating 

capacity is limited to the first 250 

registrants. 

Authority: Section 503 of Pub. L. 108–173. 

Dated: October 28, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–27579 Filed 11–20–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Generic Clearance for the 

Collection of Qualitative Feedback on 

Agency Service Delivery. 

OMB No.: 0970–0401. 

Description: Executive Order 12862 

directs Federal agencies to provide 

service to the public that matches or 

exceeds the best service available in the 

private sector. In order to work 

continuously to ensure that the 

Administration for Children and 

Families’ programs are effective and 

meet our customers’ needs we use a 

generic clearance process to collect 

qualitative feedback on our service 

delivery. This collection of information 

is necessary to enable ACF to garner 

customer and stakeholder feedback in 

an efficient timely manner, in accord 

with our commitment to improving 

service delivery. The information 

collected from our customers and 

stakeholders will help ensure that users 

have an effective, efficient and 

satisfying experience with the programs. 

This feedback will provide insights into 

customer or stakeholder perceptions, 

experiences and expectations, provide 

an early warning of issues with service, 

mstockstill on DSK4VPTVN1PROD with NOTICES