48164 Federal Register / Vol. 78, No. 152 / Wednesday, August 7, 2013 / Notices 

government. As required by the Federal 

Property Management Regulations, Title 

41, Code of Federal Regulation, Subpart 

101–20.301, all persons entering in or 

on Federal controlled property and their 

packages, briefcases, and other 

containers in their immediate 

possession are subject to being x-rayed 

and inspected. Federal law prohibits the 

knowing possession or the causing to be 

present of firearms, explosives and other 

dangerous weapons and illegal 

substances. The meeting room 

accommodates approximately 100 

people. 

PURPOSE: This committee is charged 

with providing advice and making 

recommendations to the Secretary, 

Department of Health and Human 

Services; the Director, CDC; and the 

Director, NCHS, regarding the scientific 

and technical program goals and 

objectives, strategies, and priorities of 

NCHS. 

MATTERS TO BE DISCUSSED: The agenda 

will include welcome remarks by the 

Acting Director, NCHS; Demo of the 

NHIS Online Analytic Real-time System 

(OARS); initiation of Office of Analysis 

and Epidemiology review. 

Requests to make oral presentations 

should be submitted in writing to the 

contact person listed below. All requests 

must contain the name, address, 

telephone number, and organizational 

affiliation of the presenter. 

Written comments should not exceed 

five single-spaced typed pages in length 

and must be received by September 4, 

2013. 

The agenda items are subject to 

change as priorities dictate. 

CONTACT PERSON FOR MORE INFORMATION: 

Virginia S. Cain, Ph.D., Director of 

Extramural Research, NCHS/CDC, 3311 

Toledo Road, Room 7208, Hyattsville, 

Maryland 20782, telephone (301) 458– 

4500, fax (301) 458–4020. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both Centers 

for Disease Control and Prevention and 

the Agency for Toxic Substances and 

Disease Registry. 

Elaine L. Baker, 

Management Analysis and Services Office, 

Centers for Disease Control and Prevention. 

[FR Doc. 2013–19099 Filed 8–6–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3284–N] 

Medicare Program; Revised Process 

for Making National Coverage 

Determinations 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice updates the 

process we use for opening, deciding or 

reconsidering national coverage 

determinations (NCDs) under the Social 

Security Act (the Act). It addresses 

external requests and internal reviews 

for new NCDs or for reconsideration of 

existing NCDs. The notice further 

outlines an expedited administrative 

process to remove certain NCDs, thereby 

enabling local Medicare contractors to 

determine coverage under the Act. This 

notice does not alter or amend our 

regulations that establish rules related to 

the administrative review of NCDs. 

DATES: This notice is effective on 

August 7, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Katherine Tillman, (410) 786–9252. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In a September 26, 2003, Federal 

Register notice (68 FR 55634), we 

announced our procedures for 

considering national coverage 

determination (NCD) requests and our 

procedure for issuing NCDs, including 

the role of external public requests to 

open an NCD and our procedures for 

internally-generated NCD reviews. As 

we strive to continually improve our 

processes and in recognition of the 

changes made by the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) (Pub. 

L. 108–173, enacted on December 8, 

2003), we are superseding the 2003 

Federal Register notice with this 

updated notice. 

II. Provisions of the Notice 

This notice establishes the procedures 

for requesting an NCD or 

reconsideration of an existing NCD. We 

also describe how the public may 

participate in the NCD process during 

the indicated comment period(s). The 

topics addressed in the notice include 

the following: 

• Informal contacts and inquiries 

prior to requesting a national coverage 

determination. 

• What constitutes a complete, formal 

request for an NCD or formal request for 

reconsideration of an existing NCD. 

• External requests for NCDs, 

including the following: 

++ Request by an external party for a 

new NCD. 

++ Request by an external party for 

reconsideration of an existing NCD. 

++ Request by an aggrieved party (as 

defined below) to issue an NCD when 

no NCD exists. 

• CMS internally-generated review of 

NCDs, including the following: 

++ CMS internal review for a new 

NCD. 

++ CMS internal review for 

reconsideration of an existing NCD. 

• An expedited process to remove 

NCDs under certain circumstances. 

Based on our experience since 2003 

with the current NCD process, we are 

establishing a new procedure to be used 

in circumstances in which we have 

previously issued an NCD, but have 

now determined that the NCD is no 

longer needed. Since we would not be 

establishing a new NCD, we would use 

an expedited process to remove these 

NCDs. After the effective date of the 

removal of the NCD, local Medicare 

contractors would determine coverage 

under section 1862(a)(1) of the Act for 

those specific items or services 

previously addressed through the NCD. 

We describe this process and the 

opportunity for public participation in 

this process in section IV.C of this 

notice. 

We are also restating our process for 

developing an NCD to provide clarity 

and transparency for the public 

pertaining to modifications made to the 

coverage process since the MMA. As in 

the 2003 Federal Register notice, we 

will inform the public by addressing the 

following in this notice: 

• The internal and external processes 

for requesting an NCD or an NCD 

reconsideration. 

• A tracking system that provides 

public notice of our acceptance of a 

complete, formal request and 

subsequent actions in a web-based 

format. 

• The process we use to afford notice 

and opportunity for public comment 

before issuing a decision memorandum. 

• How we use public comments to 

inform the NCD final decision. 

We continue to pursue our efforts to 

work with various sectors of the 

scientific and medical community to 

develop and publish on our Web site 

documents that describe our approach 

when analyzing scientific and clinical 

evidence to develop an NCD. The CMS 

coverage Web site can be accessed at 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 78, No. 152 / Wednesday, August 7, 2013 / Notices 48165 

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

Coverage/CoverageGenInfo/index.html. 

III. Medicare Coverage—General 

Principles 

A. Statutory Authority 

The Medicare program was 

established by Title XVIII of the Act. 

Part A is the hospital insurance program 

and Part B is the voluntary 

supplementary medical insurance 

program. The scope of benefits available 

to eligible beneficiaries under Part A 

and Part B is prescribed by law in 

sections 1812 and 1832 of the Act. Part 

C, known as the Medicare Advantage 

Program, includes at a minimum, all of 

the items and services available under 

Part A and Part B to individuals 

enrolled in the plan. On January 1, 

2006, Medicare began to cover 

prescription drugs through a new 

voluntary and privately-administered 

Part D program, established by the 

MMA. To obtain prescription drug 

coverage, Medicare beneficiaries must 

take the affirmative step of enrolling in 

a private Medicare Part D plan that is 

either a stand-alone prescription drug 

plan (PDP) or a Medicare Advantage 

prescription drug plan (MA–PD). 

In addition, with relatively few 

exceptions, the statute provides in 

section 1862(a)(1) of the Act that no 

payment may be made under Part A or 

Part B for any expenses incurred for 

items or services which ‘‘are not 

reasonable and necessary for the 

diagnosis or treatment of illness or 

injury or to improve the functioning of 

a malformed body member.’’ The 

Supreme Court has recognized that 

‘‘[t]he Secretary’s decision as to whether 

a particular medical service is 

‘reasonable and necessary’ and the 

means by which she implements her 

decision, whether by promulgating a 

generally applicable rule or by allowing 

individual adjudication, are clearly 

discretionary decisions.’’ Heckler v. 

Ringer, 466 U.S. 602, 617 (1984). 

This notice concerns our procedures 

for making NCDs for items and services 

under Part A or Part B. NCDs serve as 

generally applicable rules to ensure that 

similar claims for items or services are 

covered in the same manner. Often an 

NCD is written in terms of defined 

clinical characteristics that identify a 

population that may or may not receive 

Medicare coverage for a particular item 

or service. The term ‘‘national coverage 

determination’’ is defined by statute and 

means a determination by the Secretary 

of the Department of Health and Human 

Services (Secretary) with respect to 

whether or not a particular item or 

service is covered nationally under Title 

XVIII of the Act. NCDs are controlling 

authorities for Medicare contractors and 

adjudicators as described more fully in 

42 CFR 405.1060. 

In the absence of an NCD, Medicare 

contractors may establish a local 

coverage determination (LCD) (defined 

in section 1869(f)(2)(B) of the Act) or 

adjudicate claims on a case-by-case 

basis. The case-by-case adjudicatory 

model permits consideration of a 

beneficiary’s particular factual 

circumstances described in the medical 

record. The case-by-case model affords 

more flexibility to consider a particular 

individual’s medical condition than is 

possible when the agency establishes a 

generally applicable rule. 

B. Differences Between Food and Drug 

Administration (FDA) and CMS Review 

Parties interested in the coverage of a 

drug or device may contact us with an 

inquiry on Medicare coverage while the 

particular drug or device is proceeding 

through the Food and Drug 

Administration (FDA) review process. 

Since the FDA is charged with 

regulating whether devices or 

pharmaceuticals are safe and effective 

for their intended use by consumers, 

generally we will not accept a coverage 

request for a device or pharmaceutical 

that has not been approved or cleared 

for marketing by the FDA for at least one 

indication; one exception is Category B 

Investigational Device Exemption (IDE) 

devices. A Category B IDE device is a 

non-experimental/investigational device 

for which the incremental risk is the 

primary risk in question (that is, 

underlying questions of safety and 

effectiveness of that device type have 

been resolved), or it is known that the 

device type can be safe and effective 

because, for example, other 

manufacturers have obtained FDA 

approval or clearance for that device 

type. 

Both CMS and FDA review scientific 

evidence and will likely review some of 

the same evidence to meet each agency’s 

mission. Among other things, FDA 

reviews evidence to determine that a 

product is safe and effective, that is, it 

conducts a premarket review of 

products under a statutory standard and 

delegated authority (67 FR 66755) 

different from that of CMS. We also 

review clinical evidence to determine, 

among other things, whether the item or 

service is reasonable and necessary for 

the diagnosis or treatment of illness or 

injury or to improve the functioning of 

a malformed body member for the 

affected Medicare beneficiary 

population. An FDA-regulated product 

must receive FDA approval or clearance 

(unless exempt from the FDA premarket 

review process) for at least one 

indication to be eligible for 

consideration of Medicare coverage 

(except in specific circumstances). 

However, FDA approval or clearance 

alone does not entitle that technology to 

Medicare coverage. 

IV. CMS’ Process for Making a National 

Coverage Determination 

Section 1862(l) of the Act establishes, 

among other things, a timeframe for the 

NCD process and an opportunity for 

public comment on the agency’s 

proposed decisions. 

A. Informal Contacts and Inquiries 

Before Requesting an NCD 

We encourage, but do not require, 

potential requesters to communicate, via 

conference call or meeting, with our 

staff in the Coverage and Analysis 

Group (CAG) within the Center for 

Clinical Standards and Quality (CCSQ) 

before submission of a formal request. 

We have found that an initial 

submission of a ‘‘formal request’’ 

without any conversation with us 

generally requires additional 

clarification and discussion before we 

can definitively act on the request. A 

summary of the item or service and 

supporting documentation can be 

presented by the requester, and our staff 

can identify additional information that 

might be needed or helpful. Preliminary 

discussions are also the appropriate 

time for the requester to identify clinical 

trial protocols whose results will be 

later submitted to support an NCD 

request, if relevant. A positive response, 

however, to a clinical trial protocol is 

not an indication of forthcoming 

Medicare coverage. 

A significant proportion of potential 

requesters have either withdrawn or 

substantially amended their initial 

requests after informal discussion with 

us. These instances have generally 

included one or more of the following 

factors: 

• Existing coverage of the item or 

service is already available at the 

national or local level. 

• The substance of the request 

concerns the coding or payment amount 

for the item or service and is therefore 

outside the scope of an NCD. 

• The item or service falls outside the 

scope of the Medicare Part A and Part 

B benefits. 

• The requester learns that the item or 

service, even if covered, would not be 

separately paid under the Medicare 

program, for example, the item or 

service would be included in a bundled 

payment. 

mstockstill on DSK4VPTVN1PROD with NOTICES

48166 Federal Register / Vol. 78, No. 152 / Wednesday, August 7, 2013 / Notices 

• The requester recognizes the 

request would not be supported by a 

persuasive body of evidence. 

Informal communications between us 

and the requester allow both parties to 

clarify the NCD request and discuss 

potential issues that would affect our 

review and implementation of coverage 

of the item or service, such as the issues 

discussed above. These meetings and 

conversations expedite consideration 

and ensure that the requester 

understands that all relevant materials 

must be submitted in a timely manner 

and not delay the opening of the NCD 

review. 

B. What Constitutes a Complete, Formal 

Request for an NCD or a Complete, 

Formal Request for Reconsideration 

We can initiate an NCD request or one 

can be initiated by an individual, 

(including a beneficiary), or an entity 

(including a medical professional 

society or business interest). We require 

that any request for an NCD review be 

a written ‘‘complete, formal request.’’ 

Acceptance of a complete, formal 

request indicates that we have sufficient 

information to conduct the NCD review. 

A request is considered to be a 

complete, formal request once the 

following conditions are met: 

• The requester has provided a final 

letter of request that is not marked as a 

draft, and is clearly identified as ‘‘A 

Formal Request for a National Coverage 

Determination.’’ The requester must 

identify and submit the scientific 

evidence that he or she believes 

supports the request for coverage. Our 

review, however, is not limited to the 

materials submitted by the requester. 

• Supporting documentation must 

include a full and complete description 

of the item or service in the request and 

scientific evidence supporting the 

clinical indications for the item or 

service. This includes a specific detailed 

description of the proposed use of the 

item or service, including the target 

Medicare population and the medical 

indication(s) for which it can be used 

and whether the item or service is 

intended for use by health care 

providers or beneficiaries. 

• If the requester has submitted an 

application to the FDA for premarket 

approval or 510(k) clearance of the 

product for which coverage is sought, a 

copy of the ‘‘integrated summary of 

safety data’’ and ‘‘integrated summary of 

effectiveness data’’, or the combined 

‘‘summary of safety and effectiveness 

data’’ portions of the FDA application 

must be included. (Section 510(k) of the 

Food, Drug, and Cosmetic Act requires 

device manufacturers who must register, 

to notify FDA of their intent to market 

a medical device at least 90 days in 

advance.) 

• In the case of items or services that 

are eligible for a 510(k) clearance by the 

FDA, the request must include 

identification of the predicate devices to 

which the item or service is claimed to 

be substantially equivalent. 

• The request must include 

information regarding the use of an item 

or service (for example, drug or device) 

subject to FDA regulation as well as the 

status of current FDA regulatory review 

of the item or service involved. An FDA 

regulated item or service would include 

the labeling submitted to FDA or 

approved by the FDA for that article, 

together with an indication of whether 

the article for which review is being 

requested is covered under the labeled 

indication(s). We recognize that the 

labeling on FDA-approved products 

sometimes changes. For purposes of our 

review, we are interested in the labeled 

indications at the time a requester 

submits a formal request. If during our 

review, the labeled indication or status 

of pending FDA approval or clearance 

changes, the requester must notify us of 

those changes. 

• The request must state the Medicare 

Part A or Part B benefit category or 

categories in which the requester 

believes the item or service falls. 

Medicare does not develop NCDs to 

establish coverage of items or services 

that fall outside the scope of the Part A 

or Part B benefits. 

• Requests for NCDs may be 

submitted electronically via the 

Coverage Center Web site using the 

‘‘Contact Us’’ link at http:// 

www.cms.gov/Medicare/Coverage/ 

InfoExchange/contactus.html. 

Requests may also be submitted to the 

Centers for Medicare & Medicaid 

Services; Director, Coverage and 

Analysis Group; 7500 Security Blvd.; 

Baltimore, MD 21244. 

We will consider a request to be a 

complete, formal request if the 

following conditions are met: 

• The request is in writing. 

• The request clearly identifies the 

statutorily-defined benefit category to 

which the requester believes the item or 

service applies and contains enough 

information for us to make a benefit 

category determination. 

• The request is accompanied by 

sufficient, supporting evidentiary 

documentation. 

• The information provided addresses 

relevance, usefulness, or the medical 

benefits of the item or service to the 

Medicare population. 

• The information fully explains the 

design, purpose, and method of using 

the item or service for which the request 

is made. 

C. External Requests for National 

Coverage Determinations 

1. Request by an External Party for a 

New National Coverage Determination 

Typically, a requester is a Medicare 

beneficiary, a manufacturer, a physician 

or a physician professional association. 

A request may be to establish, limit, or 

entirely remove coverage. 

Upon acceptance of a complete, 

formal request, publication of a tracking 

sheet on the CMS Web site enables 

interested individuals to participate in 

and monitor the progress of our review. 

The tracking sheet contains a reference 

number, the name of the issue under 

consideration, requests for public 

comments, and summarizes the 

significant actions we have taken. The 

tracking sheet is a key element in 

making our NCD process efficient, open, 

and accessible to the public. 

A formal evidence review is then 

undertaken to determine whether or not 

an unbiased interpretation of the 

available evidence base supports or 

refutes the requested coverage in whole 

or in part. A proposed decision is 

normally issued for public comment 

within six months of opening the NCD 

review. Consistent with section 

1862(l)(3)(B) of the Act, we provide 30 

days for public comment on the 

proposal. Not later than 60 days after 

the close of the 30-day public comment 

period, we issue a final NCD. The final 

NCD decision memorandum includes a 

summary of the public comments on the 

proposed decision as well as responses 

to those comments. The proposed and 

final memoranda also include the 

scientific basis for our coverage 

determination, for example, an analysis 

and summary of the evidence 

considered (including medical, 

technical, and scientific evidence). The 

statutory timeframes, however, vary 

depending on whether or not we 

commission a technology assessment 

from an outside entity, or whether we 

decide to convene the Medicare 

Evidence Development and Coverage 

Advisory Committee (MEDCAC) to 

discuss the quality of the evidence, or 

whether a clinical trial is requested. 

2. Request by an External Party for 

Reconsideration of an Existing NCD 

When an NCD currently exists, any 

individual or entity may request that we 

reconsider any provision of that NCD by 

filing a complete formal request for 

reconsideration. Similar to a request for 

a new NCD, the request for 

reconsideration must be submitted in 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 78, No. 152 / Wednesday, August 7, 2013 / Notices 48167 

writing and be clearly identified. We 

consider accepting a request to revise an 

existing NCD at any time, but only if the 

requester presents documentation that 

meets one of the following criteria: 

• Additional scientific evidence that 

was not considered during the most 

recent review along with a sound 

premise by the requester that new 

evidence may change the NCD decision. 

• Plausible arguments that our 

conclusion materially misinterpreted 

the existing evidence at the time the 

NCD was decided. 

Similar to a request for a new NCD, 

we consider a reconsideration request to 

be a ‘‘complete, formal request’’ if the 

following conditions are met: 

• The requester provides a final letter 

of request (for example, not marked as 

a ‘‘draft’’), and clearly identifies the 

request as a ‘‘Formal Request for NCD 

Reconsideration.’’ 

• The requester identifies the 

scientific evidence that he or she 

believes supports the request for 

reconsideration (see above). Our review, 

however, is not limited to the materials 

submitted by the requester. 

• The written request includes and 

supports any additional Medicare Part A 

or Part B benefit categories in which the 

requester believes the item or service 

falls. 

• The request includes supporting 

documentation and is received 

electronically (unless there is good 

cause for only a hardcopy submission 

such as inability to scan necessary 

documents for electronic submission or 

lack of access to an electronic method 

of submission). Requests for NCDs may 

be submitted electronically via the 

Coverage Center Web site using the 

‘‘Contact Us’’ link. Requests may also be 

submitted to the Centers for Medicare & 

Medicaid Services; Director, Coverage 

and Analysis Group; 7500 Security 

Blvd.; Baltimore, MD 21244. 

We review materials presented in a 

complete, formal request by the 

requester. We also review other related 

clinical materials before accepting a 

request for reconsideration. In a change 

from the 2003 Federal Register notice 

and because of the time required for 

clinical research, reviews and analysis 

in a global health arena, we have 

determined that 60 days is usually a 

reasonable time period for us to make a 

decision to accept or reject decline an 

external NCD reconsideration request. If 

we accept the request, we post the letter 

requesting reconsideration together with 

a tracking sheet announcing that a 

reconsideration of the NCD has begun. 

If we decline the request, we will send 

a letter to the requester, rejecting the 

reconsideration request. 

3. Request by an Aggrieved Party To 

Issue a Coverage or Noncoverage NCD 

Section 1869(f)(4) of the Act permits 

certain aggrieved persons to make a 

request that the Secretary issue a 

national coverage or noncoverage 

determination with respect to a 

particular type or class of items or 

services, if the Secretary has not made 

a national coverage or noncoverage 

determination. These individuals are 

described in section 1869(f)(5) of the 

Act as ‘‘individuals entitled to benefits 

under Part A, or enrolled under Part B, 

or both, who are in need of the item or 

service that is the subject of the 

coverage determination.’’ Thus, this 

option can be invoked only for an initial 

request if we have not issued a coverage 

or noncoverage NCD. In these rare 

instances related to requests made by 

aggrieved parties, the statute establishes 

specific time deadlines for our 

consideration of such requests and we 

will notify the public through the 

posting of the NCD Tracking sheet when 

this occurs. 

D. Internally-Generated NCD Review 

1. Internally-Generated Review of an 

NCD 

We may internally initiate the NCD 

process. The following are examples of 

circumstances that may prompt us, 

when supported by our initial 

investigation of available evidence for 

review, to generate an internal NCD 

review on new or longstanding items or 

services: 

• Practitioners, patients, or other 

members of the public have raised 

significant questions about the health 

outcomes attributable to the use of the 

items or services for the Medicare 

beneficiary population. 

• New evidence or reasonable reinterpretation of previously available 

evidence indicates that a national 

coverage review may be warranted. 

• Local coverage policies on a 

particular item or service may vary in 

language or implementation. While this 

may be manifested by LCD variations 

among Medicare Administrative 

Contractors (MACs), we note that 

variability is not a de facto sign of 

inappropriate local policy and may be 

appropriate. 

• The health technology represents a 

substantial clinical advance and is 

likely to result in a significant 

improvement in patient health 

outcomes or positive impact on the 

Medicare program. 

• When rapid diffusion of an item or 

service is anticipated the evidence may 

inadequately address questions 

regarding impact on the Medicare 

population, target subgroup 

populations, practitioner or facility 

qualifications, etc., or on beneficiary 

health outcomes. Under these 

particularly complex circumstances, we 

may also require a comprehensive 

technology assessment, or convene a 

MEDCAC meeting to discern and 

evaluate those complexities and help 

inform our national decision. 

2. Internally-Generated NCD 

Reconsideration Review 

We may also internally open a 

reconsideration of any policy or of an 

entire NCD. Generally, we internally 

open an NCD reconsideration because 

we have become aware of new evidence 

that could support a material change in 

coverage and we seek public comment 

on relevant questions. 

E. Expedited Process To Remove an 

NCD Using Certain Criteria 

We recognize the need to periodically 

review our policies and processes to 

ensure that we remain effective and 

efficient as well as open and 

transparent. We are aware that clinical 

science and technology evolve and that 

items and services that were once 

considered state-of-the-art or cutting 

edge may be replaced by more beneficial 

technologies or clinical paradigms. 

Therefore, we are announcing an 

administrative procedure to periodically 

review the inventory of NCDs that are 

older than 10 years since their most 

recent review and evaluate the 

continued need for those policies to 

remain active on a national scale. We 

are administratively simplifying the 

Medicare program by removing NCDs in 

circumstances described below. This 

process of removal would not result in 

an NCD as that term is defined in 

sections 1869(f) and 1862(l) of the Act 

because there would be no uniform 

national decision about whether or not 

the particular item or service would be 

covered under Title XVIII of the Act. 

Rather, the initial coverage decision 

under section 1862(a)(1)(A) of the Act 

for the particular item or service would 

be made by local contractors. We 

believe that allowing local contractor 

discretion in these cases better serves 

the needs of the Medicare program and 

its beneficiaries since we believe the 

future utilization for items and services 

within these policies will be limited. 

This expedited procedure allows us to 

regularly identify and remove NCDs that 

no longer contain clinically pertinent 

and current information or that involve 

items or services that are used 

infrequently by beneficiaries. As the 

scientific community continues to 

pursue research in certain areas, the 

mstockstill on DSK4VPTVN1PROD with NOTICES

48168 Federal Register / Vol. 78, No. 152 / Wednesday, August 7, 2013 / Notices 

evidence base we previously reviewed 

may have evolved to support other 

policy conclusions. Alternatively, in 

some circumstances, removing an NCD 

has the effect of striking national 

noncoverage and may permit access to 

technologies that may be beneficial for 

some limited uses. 

Under this process, we will 

periodically publish on our Web site, a 

list of NCDs proposed for removal along 

with our rationale for their proposed 

removal. We will solicit public 

comment for 30 calendar days. This will 

invite the public to comment on 

whether any or all of these NCDs should 

be removed or retained. In addition, we 

will ask the commenters to include a 

rationale to support their comments. We 

use the public comments to help inform 

our decision to do one of the following: 

• Follow the proposal to remove the 

NCD. 

• Retain the policy as an NCD. 

• Formally reconsider the NCD and 

post a tracking sheet to that effect on the 

Coverage Web site. 

We consider all the public comments 

when developing a final NCD list for 

removal. When the final NCD list for 

removal is posted to our Coverage Web 

site, we summarize the comments and 

briefly explain our rationale as to why 

a specific NCD remained active, was 

removed from active national status, or 

qualified for reconsideration. The final 

list will be effective upon posting it to 

the Web site. 

Currently, an existing NCD must 

undergo a formal reconsideration 

process to be removed or amended and 

the process generally takes 9 to 12 

months. We expect this new 

administrative procedure to reduce that 

time significantly. We believe that this 

streamlined process is more efficient 

and helpful to the public because it 

instills confidence that national policies 

are being monitored to ensure health 

benefits for Medicare beneficiaries 

remain current. 

We may consider an older NCD for 

removal if, among other things, any of 

the following circumstances apply: 

• We believe that allowing local 

contractor discretion better serves the 

needs of the Medicare program and its 

beneficiaries. 

• The technology is generally 

acknowledged to be obsolete and is no 

longer marketed. 

• In the case of a noncoverage NCD 

based on the experimental status of an 

item or service, the item or service in 

the NCD is no longer considered 

experimental. 

• The NCD has been superseded by 

subsequent Medicare policy. 

• The national policy does not meet 

the definition of an ‘‘NCD’’ as defined 

in sections 1862(l) or 1869(f) of the Act. 

• The benefit category determination 

is no longer consistent with a category 

in the Act. 

V. CMS’ Evaluation of Requests for an 

NCD and Related Tasks 

When we receive a request for an 

NCD, we review the submitted material 

to determine if it is a complete, formal 

written request. If it is not a complete, 

formal request it does not trigger the 

NCD statutory timeline because we do 

not have a clear basis upon which to act 

on the inquiry. In these instances, we 

notify the requester and explain our 

rationale, so the requester has the 

opportunity to provide missing 

information. As we explain elsewhere in 

this notice, many of the incomplete or 

informal inquiries we have received in 

the past did not ultimately result in a 

formal request. 

Upon acceptance of a complete, 

formal, request, posting of the tracking 

sheet on our Web site facilitates the 

ability of interested individuals to 

participate in, and monitor, the progress 

of our review. This is a key element in 

making our NCD process more efficient, 

open, and accessible to the public. 

We then undertake a formal evidence 

review to determine whether or not an 

unbiased interpretation of the available 

evidence base supports or refutes the 

requested coverage in whole or in part. 

We may also consider the need to obtain 

additional input through technology 

assessments from an outside entity and/ 

or deliberation by the Medicare 

Evidence Development and Coverage 

Advisory Committee (MEDCAC). A 

formal review may result in an NCD, a 

noncoverage NCD, or an NCD with 

limitations. We also may determine that 

no NCD is required, permitting local 

Medicare contractors to make the initial 

determination under section 1862(a)(1) 

of the Act. 

VI. Public Comment 

We strive to conduct the NCD process 

in an open and transparent manner with 

thoughtful consideration of public 

comment. We have found that public 

commenters may cite published clinical 

evidence, contribute insight, and give us 

useful information. We are particularly 

interested in comments that include 

new evidence we have not reviewed for 

the proposed decision or in past 

considerations of the NCD. Comments 

should be timely and pertinent to the 

NCD. We respond in detail to the public 

comments on a proposed decision in the 

final decision memorandum. 

While the statute affords an 

opportunity for public comment on the 

proposed decisions, we may also solicit 

public comment upon the initial 

opening of an NCD review announced 

via the tracking sheet. We use the initial 

public comments to inform our 

proposed decision and respond in detail 

to the public comments on a proposed 

decision when issuing the final decision 

memorandum. 

Also, we may, at our discretion, open 

a proposed decision concurrently with 

the notice of opening an NCD. This 

occurs rarely when we determine it is 

efficient to reduce the time necessary to 

manage an unforeseen health related 

issue or program need that must be 

resolved quickly. We may also use our 

discretion, as we have publicly stated, 

in an attempt to expedite a final NCD for 

requests that are accepted in the FDA 

CMS parallel review project (see the 

notice published on October 11, 2011 

(76 FR 62808 through 62810)). 

Public comments providing 

information on unpublished evidence, 

such as the results obtained by 

individual practitioners or patients, are 

less rigorous and therefore less useful 

for making a coverage determination. 

Public comments that contain 

personally identifiable health 

information are either redacted or not 

made available to the public. Comments 

containing extensive personal health 

information may leave no substantive 

comment after redaction. 

We prefer to receive comments 

electronically; as these are more 

efficiently reviewed, catalogued, and 

redacted for personally identifiable 

health information. If a commenter 

chooses to submit comments through 

more than one channel, duplicate 

submissions are treated as a single 

comment. 

In general, we avoid opening and 

closing public comment periods on 

federal holidays or weekends. We may 

have limited ability to accommodate 

this goal, however, under tight statutory 

deadlines. 

VII. Prioritizing Requests 

In the event that we have a large 

volume of NCD requests for 

simultaneous review, we prioritize these 

requests based on the magnitude of the 

potential impact on the Medicare 

program and its beneficiaries and 

staffing resources. 

VIII. Time Frames 

We strive to complete NCD-related 

activities in a timely and efficient 

manner, often before statutory 

deadlines. We prepare an annual Report 

to Congress that tracks our performance 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 78, No. 152 / Wednesday, August 7, 2013 / Notices 48169 

with respect to certain key steps in the 

process which is also posted on our 

Web site. The following steps and time 

frames are used for new NCDs and for 

reconsiderations of existing NCDs: 

• Upon acceptance of a complete 

formal request or upon the opening of 

a CMS initiated review, we publish on 

our Web site a tracking sheet that 

provides public notice of the opening of 

the NCD process. We generally allow a 

30-day public comment period on the 

NCD review topic announced via the 

tracking sheet. We use the initial public 

comments to inform a proposed 

decision. As stated above, at our 

discretion, we may announce a 

proposed decision concurrent with the 

notice of opening. 

• A proposed decision is posted no 

later than 6 months after the posting of 

the tracking sheet, unless a technology 

assessment (TA) from an outside entity 

is commissioned, a clinical trial is 

requested, or a meeting of the MEDCAC 

is convened. 

• In the event that a TA is 

commissioned from an outside entity or 

a MEDCAC meeting is held and a 

clinical trial is not requested, the 

proposed decision is posted no later 

than 9 months following the posting of 

the tracking sheet. 

• Upon the posting of the proposed 

decision, there is a 30-day public 

comment period during which time the 

public is invited to comment on the 

substance of the proposed decision. 

• A final NCD is posted on our Web 

site no later than 60 days following the 

close of the public comment period on 

the proposed decision. 

• With publication of the final 

decision memorandum, the NCD is 

effective for claims with dates of service 

beginning with the effective date of the 

NCD. The memorandum contains, 

among other materials, the analysis and 

conclusions and also the NCD that 

becomes a part of the Medicare National 

Coverage Determination Manual (Pub. 

100–3) of the CMS Internet Only 

Manual. After enactment of section 

1862(l) of the Act, the effective date for 

the NCD is the same date as the 

publication date of the final decision 

memorandum. Therefore, we have 

found it expedient and practical to 

include the NCD that is included in the 

Medicare National Coverage 

Determination manual in the final 

decision memoranda and to use that 

date as the effective date for Medicare 

coverage and payment purposes. 

IX. Collection of Information 

Requirements 

This document does not impose any 

new reporting, recordkeeping or thirdparty disclosure requirements. This 

document, however, does make 

reference to information associated with 

an existing information collection 

request. The information listed in 

section IV.B ‘‘What Constitutes a 

Complete, Formal Request for a National 

Coverage Determination or a Complete, 

Formal Request for Reconsideration’’ of 

this notice, was previously approved 

under OMB control number 0938–0776. 

We are currently seeking reinstatement 

of the OMB control number and the 

information collection requirements. We 

published the required 60-day notice on 

February 12, 2013 (78 FR 9927). The 60- 

day comment period ended April 15, 

2013. We will announce the submission 

of the information collection request to 

OMB via the required 30-day notice. 

Authority: (Catalog of Federal Domestic 

Assistance Program No. 93.778, Medical 

Assistance Program; No. 93.773 Medicare— 

Hospital Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: May 17, 2013. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: May 17, 2013. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2013–19060 Filed 8–2–13; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Privacy Act of 1974; CMS Computer 

Match No. 2013–02; HHS Computer 

Match No. 1306; DoD–DMDC Match No. 

12 

AGENCY: Department of Health and 

Human Services (HHS), Centers for 

Medicare & Medicaid Services (CMS). 

ACTION: Notice of Computer Matching 

Program (CMP). 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

as amended, this notice establishes a 

CMP that CMS plans to conduct with 

the Department of Defense (DoD). 

DATES: Effective Dates: Comments are 

invited on all portions of this notice. 

Public comments are due 30 days after 

publication. The matching program will 

become effective no sooner than 40 days 

after the report of the matching program 

is sent to OMB and Congress, or 30 days 

after publication in the Federal 

Register, whichever is later. 

ADDRESSES: The public should send 

comments to: CMS Privacy Officer, 

Division of Privacy Policy, Privacy 

Policy and Compliance Group, Office of 

E-Health Standards & Services, Offices 

of Enterprise Management, CMS, Room 

S2–24–25, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

Comments received will be available for 

review at this location, by appointment, 

during regular business hours, Monday 

through Friday from 9:00 a.m.–3:00 

p.m., Eastern Time zone. 

FOR FURTHER INFORMATION CONTACT: 

Celeste Dade-Vinson, Division of 

Privacy Policy, Privacy Policy and 

Compliance Group, Office of E-Health 

Standards & Services, Offices of 

Enterprise Management, CMS, Mail stop 

S2–26–17, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850, Office 

Phone: 410–786–0854, Facsimile: 410– 

786–1347, Email: Celeste.DadeVinson@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Computer Matching and Privacy 

Protection Act of 1988 (Public Law 

(Pub. L.) 100–503), amended the Privacy 

Act (5 U.S.C. 552a) by describing the 

manner in which computer matching 

involving Federal agencies could be 

performed and adding certain 

protections for individuals applying for 

and receiving Federal benefits. 

Section 7201 of the Omnibus Budget 

Reconciliation Act of 1990 (Pub. L. 101– 

508) further amended the Privacy Act 

regarding protections for such 

individuals. The Privacy Act, as 

amended, regulates the use of computer 

matching by Federal agencies when 

records in a system of records are 

matched with other Federal, state, or 

local government records. It requires 

Federal agencies involved in computer 

matching programs to: 

1. Negotiate written agreements with 

the other agencies participating in the 

matching programs; 

2. Obtain the Data Integrity Board 

approval of the match agreements; 

3. Furnish detailed reports about 

matching programs to Congress and 

OMB; 

4. Notify applicants and beneficiaries 

that the records are subject to matching; 

and, 

5. Verify match findings before 

reducing, suspending, terminating, or 

denying an individual’s benefits or 

payments. 

This matching program meets the 

requirements of the Privacy Act of 1974, 

as amended. 

mstockstill on DSK4VPTVN1PROD with NOTICES