31620 Federal Register / Vol. 77, No. 103 / Tuesday, May 29, 2012 / Notices 

Dated: May 4, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–12633 Filed 5–25–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1441–N] 

Medicare Program; Public Meeting in 

Calendar Year 2012 for New Clinical 

Laboratory Tests Payment 

Determinations 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces a 

public meeting to receive comments and 

recommendations from the public on 

the appropriate basis for establishing 

payment amounts for new or 

substantially revised Healthcare 

Common Procedure Coding System 

(HCPCS) codes being considered for 

Medicare payment under the clinical 

laboratory fee schedule (CLFS) for 

calendar year (CY) 2013. 

DATES: Meeting Dates: The public 

meeting is scheduled for Monday, July 

16, 2012, from 9:00 a.m. to 5:00 p.m., 

and Tuesday, July 17, 2012, from 9:00 

a.m. to 12:00 p.m. All times are Eastern 

Daylight Savings Time. 

Deadline for Registration of 

Presenters: All presenters for the public 

meeting must register by July 6, 2012. 

Deadline for Written/Electronic 

Presentations: Written presentations 

must also be electronically submitted to 

on or before July 6, 2012. 

Deadline for Submitting Requests for 

Special Accommodations: Requests for 

special accommodations must be 

received no later than 5:00 p.m., on July 

6, 2012. 

Deadline for Submission of Written 

Comments: Interested parties may 

submit written comments on the 

proposed payment determinations by 

September 28, 2012, to the address 

specified in the ADDRESSES section of 

this notice. 

ADDRESSES: The public meeting will be 

held in the main auditorium of the 

central building of the Centers for 

Medicare & Medicaid Services (CMS), 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

FOR FURTHER INFORMATION CONTACT: 

Glenn McGuirk, (410) 786–5723. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 531(b) of the Medicare, 

Medicaid, and SCHIP Benefits 

Improvement and Protection Act of 

2000 (BIPA) (Pub. L. 106–554) requires 

the Secretary to establish procedures for 

coding and payment determinations for 

new clinical diagnostic laboratory tests 

under Part B of title XVIII of the Social 

Security Act (the Act) that permit public 

consultation in a manner consistent 

with the procedures established for 

implementing coding modifications for 

International Classification of Diseases 

(ICD–9–CM). The procedures and public 

meeting announced in this notice for 

new tests are in accordance with the 

procedures published in the Federal 

Register on November 23, 2001 (66 FR 

58743), to implement section 531(b) of 

BIPA. 

Section 942(b) of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) (Pub. 

L. 108–173) added section 1833(h)(8) of 

the Act. Section 1833(h)(8)(A) of the Act 

requires the Secretary to ‘‘establish by 

regulation procedures for determining 

the basis for, and amount of, payment 

for any clinical diagnostic laboratory 

test with respect to which a new or 

substantially revised HCPCS code is 

assigned on or after January 1, 2005’’ 

(hereinafter referred to as, ‘‘new test’’). 

A code is considered to be 

‘‘substantially revised’’ if ‘‘there is a 

substantive change to the definition of 

the test or procedure to which the code 

applies (such as a new analyte or a new 

methodology for measuring an existing 

analyte-specific test).’’ (See section 

1833(h)(8)(E)(ii) of the Act.) 

Section 1833(h)(8)(B) of the Act sets 

forth the process for determining the 

basis for, and the amount of, payment 

for new tests. Section 1833(h)(8)(B)(i) 

and (ii) of the Act requires the Secretary 

to—(1) ‘‘make available to the public 

(through an Internet Web site and other 

appropriate mechanisms)a list that 

includes any such test for which 

establishment of a payment amount is 

being considered for a year’’; and (2) 

‘‘on the same day such list is made 

available, causes to have published in 

the Federal Register notice of a meeting 

to receive comments and 

recommendations (and data on which 

recommendations are based) from the 

public on the appropriate basis * * * 

for establishing payment amounts for 

the tests on such list.’’ The list of codes 

for which the establishment of a 

payment amount under the CLFS is 

being considered for CY 2013 is posted 

on our Web site at http:// 

www.cms.hhs.gov/ClinicalLabFeeSched. 

Section 1833(h)(8)(B)(iii) of the Act 

requires that we convene a public 

meeting not less than 30 days after 

publication of the notice in the Federal 

Register. These requirements are 

codified at 42 CFR part 414, subpart G. 

Two methods are used to establish 

payment amounts for new tests. The 

first method called ‘‘crosswalking’’ is 

used when a new test is determined to 

be comparable to an existing test, 

multiple existing test codes, or a portion 

of an existing test code. The new test 

code is assigned to the local fee 

schedule amounts and the national 

limitation amount of the existing test. 

Payment for the new test is made at the 

lesser of the local fee schedule amount 

or the national limitation amount. (See 

§ 414.508(a).) 

The second method called 

‘‘gapfilling’’ is used when no 

comparable existing test is available. 

When using this method, instructions 

are provided to each Medicare carrier or 

Part A and Part B Medicare 

Administrative Contractor (MAC) to 

determine a payment amount for its 

carrier geographic area(s) for use in the 

first year. The carrier-specific amounts 

are established for the new test code 

using the following sources of 

information, if available: charges for the 

test and routine discounts to charges; 

resources required to perform the test; 

payment amounts determined by other 

payers; and charges, payment amounts, 

and resources required for other tests 

that may be comparable or otherwise 

relevant. In the second year, the test 

code is paid at the national limitation 

amount, which is the median of the 

carrier-specific amounts. (See 

§ 414.508(b).) 

II. Proposals in the CY 2013 Physician 

Fee Schedule Proposed Rule 

We are following our process to 

determine the appropriate basis and 

payment amount for new test codes 

under the CLFS for CY 2013. Some of 

these tests are molecular pathology 

tests. Stakeholders in the molecular 

pathology community continue to 

debate whether Medicare should pay for 

molecular pathology tests under the 

CLFS or the physician fee schedule 

(PFS). Medicare pays for clinical 

diagnostic laboratory tests through the 

CLFS and for services that ordinarily 

require physician work through the PFS. 

We believe that we would benefit from 

additional public comments on whether 

these tests are clinical diagnostic 

laboratory tests or whether they are 

services that should be paid under the 

PFS. Therefore, we intend to solicit 

public comments on this issue in the CY 

2013 PFS proposed rule as well as 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 103 / Tuesday, May 29, 2012 / Notices 31621 

public comment on pricing policies for 

these tests under the PFS. We will make 

final decisions with respect to 

molecular pathology codes in the CY 

2013 PFS final rule with comment 

period, and we will post on our Web 

site the final payment determinations 

for any codes paid under the CLFS in 

November. 

In addition, we intend to post our 

proposed determinations with respect to 

the appropriate basis for establishing a 

payment amount under the CLFS for 

each of these new test codes by 

September 28, 2012. If we later decide, 

based on comments received in 

response to the proposals set forth in the 

CY 2013 PFS proposed rule, that any of 

these codes are not clinical diagnostic 

laboratory test codes, we will post our 

final payment determinations only for 

the new test codes that we determine 

are clinical diagnostic laboratory test 

codes that will be paid under the CLFS. 

We intend to post these final payment 

determinations in November (at the 

same time as the CY 2013 PFS final rule 

with comment period is published). 

Comments and recommendations on 

whether these codes represent clinical 

diagnostic laboratory tests that should 

be paid under the CLFS or services that 

should be paid under the PFS should be 

provided in response to the proposals 

set forth in the CY 2013 PFS proposed 

rule. For purposes of this public 

meeting, comments and 

recommendations should be limited to 

the appropriate basis for establishing 

payment amounts for the new test codes 

under the CLFS for CY 2013. 

III. Format 

Meeting Overview 

This meeting to receive comments 

and recommendations (including 

accompanying data on which 

recommendations are based) on the 

appropriate payment basis for the new 

test codes contained on the preliminary 

list is open to the public. The meeting 

provides a forum for interested parties 

to make presentations and submit 

written comments on new test codes. 

The development of the codes for 

clinical laboratory tests is largely 

performed by the CPT Editorial Panel 

and will not be further discussed at the 

meeting. Comments submitted should 

pertain to the payment basis for 

establishing a payment amount for the 

new test codes posted on the CMS Web 

site. 

Meeting Agenda and Instructions for 

Presenters 

The on-site check-in for visitors will 

be held from 8:30 a.m., to 9:00 a.m., 

followed by opening remarks. 

Registered persons from the public may 

discuss and recommend payment 

determinations for specific new test 

codes for the CY 2013 CLFS. 

Because of time constraints, 

presentations must be brief, lasting no 

longer than 10 minutes, and must be 

accompanied by three written copies. In 

addition, CMS recommends that 

presenters make copies available for 

approximately 50 meeting participants, 

since additional copies will not be 

provided. Written presentations must 

also be electronically submitted to CMS 

on or before July 6, 2012. In the past, the 

meeting was held on a single day. This 

year’s meeting will be held for an 

additional half day, extending the 

meeting to allow enough time for 

everyone who is interested in presenting 

information in person to be 

accommodated. However, presentation 

slots will be assigned on a first-come, 

first-served basis. In the event that there 

is not enough time for presentations by 

everyone who is interested in 

presenting, we will gladly accept 

written presentations from those who 

were unable to present due to time 

constraints. Presentations should be 

sent via email to Glenn McGuirk, at 

Glenn.McGuirk@cms.hhs.gov. Presenters 

should address all of the following 

items: 

• New test code(s) and descriptor. 

• Test purpose and method. 

• Costs. 

• Charges. 

• A recommendation, with rationale, 

for one of the two methods (crosswalking or gap-filling) for determining 

payment for new tests. 

Additionally, the presenters should 

provide the data on which their 

recommendations are based. Written 

presentations from the public meeting 

will be available upon request, via 

email, to Glenn McGuirk at 

Glenn.McGuirk@cms.hhs.gov. 

Presentations that do not address the 

above five items may be considered 

incomplete and may not be considered 

by CMS when making a payment 

determination. We may request missing 

information following the meeting in 

order to prevent a recommendation from 

being considered incomplete. 

Taking into account the comments 

and recommendations (and 

accompanying data) received at the 

public meeting, we will post our 

proposed determinations with respect to 

the appropriate basis for establishing a 

payment amount for each such code, an 

explanation of the reasons for each 

determination, the data on which the 

determinations are based, and a request 

for public written comments on the 

proposed determinations on the CMS 

Web site by early September 2012. This 

Web site can be accessed at http:// 

www.cms.hhs.gov/ClinicalLabFeeSched. 

We also will include a summary of all 

comments received by August 6, 2012 

(15 business days after the meeting). 

Interested parties may submit written 

comments on the proposed payment 

determinations by September 28, 2012, 

to the address specified in the 

ADDRESSES section of this notice. Final 

payment determinations on new test 

codes to be included for payment on the 

CLFS for CY 2013 will be posted on the 

CMS Web site in November 2012 along 

with the rationale for each such 

determination, the data on which the 

determinations are based, and responses 

to comments and suggestions received 

from the public. 

After the final payment 

determinations have been posted on the 

CMS Web site, the public may request 

reconsideration of the basis for, and 

amount of payment for, a new test as set 

forth in § 414.509. (See the November 

27, 2007 final rule (72 FR 66275 through 

66280).) 

IV. Registration Instructions 

The Division of Ambulatory Services 

in CMS is coordinating the public 

meeting registration. Beginning June 18, 

2012, registration may be completed online at the following web address: 

http://www.cms.hhs.gov/ 

ClinicalLabFeeSched. All the following 

information must be submitted when 

registering: 

• Name. 

• Company name. 

• Address. 

• Telephone number(s). 

• Email address(es). 

When registering, individuals who 

want to make a presentation must also 

specify on which new test code(s) they 

will be presenting comments. A 

confirmation will be sent upon receipt 

of the registration. Individuals must 

register by the date specified in the 

DATES section of this notice. 

V. Special Accommodations 

Individuals attending the meeting 

who are hearing or visually impaired 

and have special requirements, or a 

condition that requires special 

assistance, should provide the 

information upon registering for the 

meeting. The deadline for such 

registrations is listed in the DATES

section of this notice. 

VI. Security, Building, and Parking 

Guidelines 

The meeting will be held in a Federal 

government building; therefore, Federal 


srobinson on DSK4SPTVN1PROD with NOTICES
31622 Federal Register / Vol. 77, No. 103 / Tuesday, May 29, 2012 / Notices 

security measures are applicable. In 

planning your arrival to the CMS 

facility, we recommend allowing 

additional time to clear security. 

Attendees should arrive between 8:15 

a.m. and 8:30 a.m., in order to be 

prompt for the 9:00 a.m. meeting. 

Individuals who are not registered in 

advance will not be permitted to enter 

the building and will be unable to 

attend the meeting. The public may not 

enter the building earlier than 8:15 a.m. 

(45 minutes before the convening of the 

meeting). 

Security measures include the 

following: 

• Presentation of government-issued 

photographic identification to the 

Federal Protective Service or Guard 

Service personnel. Persons without 

proper identification may be denied 

access to the building. 

• 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. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: May 22, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–12982 Filed 5–25–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0274] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Adverse Event 

Reporting and Recordkeeping for 

Dietary Supplements as Required by 

the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by June 28, 

2012. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0428. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400T, Rockville, MD 20850, 301–796– 

5733, domini.bean@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Adverse Event Reporting and 

Recordkeeping for Dietary Supplements 

as Required by the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act—21 U.S.C. 379aa–1(b)(1) 

(OMB Control Number 0910–0635)— 

Extension 

The Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act (DSNDCPA) (Pub. L. 

109–462, 120 Stat. 3469) amends the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) with respect to serious 

adverse event reporting and 

recordkeeping for dietary supplements 

and nonprescription drugs marketed 

without an approved application. 

Section 761(b)(1) of the FD&C Act (21 

U.S.C. 379aa–1(b)(1)) requires the 

manufacturer, packer, or distributor 

whose name (under section 403(e)(1) of 

the FD&C Act (21 U.S.C. 343(e)(1))) 

appears on the label of a dietary 

supplement marketed in the United 

States to submit to FDA all serious 

adverse event reports associated with 

the use of a dietary supplement, 

accompanied by a copy of the product 

label. The manufacturer, packer, or 

distributor of a dietary supplement is 

required by the DSNDCPA to use the 

MedWatch form (FDA 3500A) when 

submitting a serious adverse event 

report to FDA. In addition, under 

section 761(c)(2) of the FD&C Act, the 

submitter of the serious adverse event 

report (referred to in the statute as the 

‘‘responsible person’’) is required to 

submit to FDA a followup report of any 

related new medical information the 

responsible person receives within 1 

year of the initial report. 

Section 761(e)(1) of the FD&C Act (21 

U.S.C. 379aa–1(e)(1)) requires that 

responsible persons maintain records 

related to the dietary supplement 

adverse event reports they receive, 

whether or not the adverse event is 

serious. Under the statute, the records 

must be retained for a period of 6 years. 

As required by section 3(d)(3) of the 

DSNDCPA, FDA issued guidance to 

describe the minimum data elements for 

serious adverse event reports for dietary 

supplements. In the Federal Register of 

July 14, 2009 (74 FR 34024), FDA 

announced the availability of guidance 

entitled ‘‘Guidance for Industry: 

Questions and Answers Regarding 

Adverse Event Reporting and 

Recordkeeping for Dietary Supplements 

as Required by the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act.’’ The guidance discusses 

how, when, and where to submit serious 

adverse event reports for dietary 

supplements and followup reports. The 

guidance also provides FDA’s 

recommendation on records 

maintenance and access for serious and 

non-serious adverse event reports and 

related documents. 

The guidance recommends that the 

responsible person document the 

attempts to obtain the minimum data 

elements for a serious adverse event 

report. Along with these records, the 

guidance recommends that the 

responsible person keep the following 

other records: (1) Communications 

between the responsible person and the 

initial reporter of the adverse event and 


srobinson on DSK4SPTVN1PROD with NOTICES