39110 Federal Register / Vol. 76, No. 128 / Tuesday, July 5, 2011 / Notices 

meetings. Please visit our Web site at 

http://healthit.hhs.gov for procedures 

on public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act 

(Pub. L. No. 92–463, 5 U.S.C., App. 2). 

Dated: June 24, 2011. 

Judith Sparrow, 

Office of Programs and Coordination, Office 

of the National Coordinator for Health 

Information Technology. 

[FR Doc. 2011–16747 Filed 7–1–11; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–5058–N] 

Medicare Program; Section 3113: The 

Treatment of Certain Complex 

Diagnostic Laboratory Tests 

Demonstration 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice informs interested 

parties of an opportunity to participate 

in the Treatment of Certain Complex 

Diagnostic Laboratory Tests 

Demonstration. The Demonstration is 

mandated by section 3113 of the 

Affordable Care Act. This notice also 

serves to notify interested parties that 

they must obtain a temporary code from 

CMS for tests currently billed using a 

‘‘not otherwise classified (NOC)’’ code 

but that would otherwise meet the 

criteria set forth in section 3113 for 

being a complex diagnostic laboratory 

test under the Demonstration. The 

statute requires a Report to Congress 

that includes an assessment of the 

impact of the Demonstration on access 

to care, quality of care, health outcomes, 

and expenditures. 

DATES: Supporting information to 

request a temporary code under the 

Demonstration is due to CMS on or 

before August 1, 2011. Payment under 

the Demonstration begins January 1, 

2012. The Demonstration will be 

conducted for two years subject to a 

$100 million payment limit. Thereafter, 

payment for these tests will be made 

under the existing non-demonstration 

process. 

ADDRESSES: Supporting information 

should be mailed to the following 

address: Centers for Medicare & 

Medicaid Services, Attention: Linda R. 

Lebovic, 7500 Security Boulevard, Mail 

Stop: C4–14–15, Baltimore, Maryland 

21244–1850. 

FOR FURTHER INFORMATION CONTACT: 

Linda R. Lebovic at (410) 786–3402 or 

by e-mail at 

ACA3113labdemo@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

General Information 

Please refer to file code [CMS–5058– 

N] on all supporting information for a 

temporary G-code under the 

Demonstration. Because of staffing and 

resource limitations, we cannot accept 

supporting information by facsimile 

(FAX) transmission. Hard copies and 

electronic copies must be identical. 

Eligible Organizations 

Under the Demonstration, an eligible 

organization is a laboratory that 

performs a complex diagnostic 

laboratory test with respect to a 

specimen collected from an individual 

during a period in which the individual 

is a patient of a hospital or critical 

access hospital (CAH) if the test is 

performed after such period of 

hospitalization and if Medicare would 

not otherwise have made separate 

payment to the laboratory for that test. 

This Demonstration will allow a 

separate payment to such laboratories 

performing tests billed with a date of 

service that would, under standard 

Medicare rules (at 42 CFR 

414.510(b)(2)(i)(A)), be bundled into the 

payment to the hospital or CAH. 

I. Background 

Section 3113(a)(2) defines the term 

‘‘complex diagnostic laboratory test’’ to 

mean a diagnostic laboratory test— (A) 

that is an analysis of gene protein 

expression, topographic genotyping, or a 

cancer chemotherapy sensitivity assay; 

(B) that is determined by the Secretary 

to be a laboratory test for which there 

is not an alternative test having 

equivalent performance characteristics; 

(C) which is billed using a Healthcare 

Common Procedure Coding System 

(HCPCS) code other than a not 

otherwise classified (NOC) code under 

such Coding System; (D) which is 

approved or cleared by the Food and 

Drug Administration or is covered 

under title XVIII of the Social Security 

Act; and (E) is described in section 

1861(s)(3) of the Social Security Act (42 

U.S.C. 1395x(s)(3)). Section 3113(a)(3) 

defines separate payment as ‘‘direct 

payment to a laboratory (including a 

hospital-based or independent 

laboratory) that performs a complex 

diagnostic laboratory test with respect to 

a specimen collected from an individual 

during a period in which the individual 

is a patient of a hospital if the test is 

performed after such period of 

hospitalization and if separate payment 

would not otherwise be made under 

title XVIII of the Social Security Act 

[(the Act)] by reason of sections 

1862(a)(14) and 1866(a)(1)(H)(i)’’ of the 

Act. In general terms, sections 

1862(a)(14) and 1866(a)(1)(H) of the Act 

state that no Medicare payment will be 

made for non-physician services, such 

as diagnostic laboratory tests, furnished 

to a hospital or CAH patient unless the 

tests are furnished by the hospital or 

CAH, either directly or under 

arrangement. The date of service rule at 

42 CFR 414.510(b)(2)(i)(A) defines the 

date of service of a clinical laboratory 

test as the date the test was performed 

only if a test is ordered by the patient’s 

physician at least 14 days following the 

date of the patient’s discharge from the 

hospital. When a test is ordered by the 

patient’s physician less than 14 days 

following the date of the patient’s 

discharge from the hospital, the hospital 

or CAH must bill Medicare for a clinical 

laboratory test provided by a laboratory 

and the hospital or CAH would in turn 

pay the laboratory if the test was 

furnished under arrangement. Under the 

Demonstration, a laboratory may bill 

Medicare directly for a complex clinical 

laboratory test which is ordered by the 

patient’s physician less than 14 days 

following the date of the patient’s 

discharge from the hospital or CAH. 

Laboratories choosing to directly bill 

Medicare under the Demonstration must 

submit a claim with a Project Identifier 

56. For purposes of the Demonstration, 

in addition to the tests that already meet 

the requirements at section 3113(a)(2) 

(see ‘‘Demonstration Test List’’ at 

http://www.cms.gov/ 

DemoProjectsEvalRpts/MD/ 

itemdetail.asp?itemID=CMS1240611), 

we will assign temporary codes based 

on the supporting information provided 

to CMS for diagnostic laboratory tests 

defined in section 3113(a)(2) but 

currently billed using NOC codes. 

Entities that bill Medicare using NOC 

codes would be permitted to bill for 

complex laboratory tests under the 

Demonstration only if they obtain a 

temporary G-code with the condition 

that information about the clinical 

laboratory service is provided to us. 

Specifically, information about 

utilization (that is, clinical use, other 

tests used in combination with or 

follow-up to this test, frequency with 

which the test could be ordered), the 

Clinical Laboratory Improvement 

Amendment certificate number of the 

laboratory performing the test, current 

billing practices (that is, codes used, 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 128 / Tuesday, July 5, 2011 / Notices 39111 

accompanying technical and/or 

professional codes, combination of 

codes billed), and costs must be 

submitted to us. 

II. Provisions of This Notice 

This notice informs interested parties 

of an opportunity to participate in the 

section 3113 Treatment of Certain 

Complex Diagnostic Laboratory Tests 

Demonstration. The authorizing 

legislation requires us to conduct a 

Demonstration for a period of 2 years 

subject to a $100 million ($100,000,000) 

limit. The Demonstration will allow a 

direct payment to a laboratory for 

certain complex diagnostic laboratory 

tests in situations where, under the date 

of service rule (see 42 CFR 

414.510(b)(2)(i)(A)), Medicare pays the 

hospital or CAH and the hospital or 

CAH, in turn, pays the laboratory 

(‘‘under arrangement’’) for laboratory 

tests. 

This notice also serves to notify 

interested parties that they must obtain 

a temporary G code from CMS for tests 

currently billed using NOC codes that 

would otherwise meet the criteria set 

forth in section 3113(a)(2). Information 

about these tests is due to CMS no later 

than August 1, 2011. The purpose of the 

August deadline is to allow time for 

CMS to determine whether the test 

meets the criteria for a complex clinical 

laboratory test and to determine 

appropriate payment amounts for tests 

paid under the Demonstration. Payment 

under the Demonstration will begin on 

January 1, 2012. 

For specific details regarding the 

section 3113 Demonstration, please refer 

to the CMS Web site at: http:// 

www.cms.gov/DemoProjectsEvalRpts/ 

MD/ 

itemdetail.asp?itemID=CMS1240611. 

III. Collection of Information 

Requirements 

The burden discussed in this notice 

pertains to the time and effort necessary 

for interested parties to obtain a 

temporary G-code from CMS for tests 

currently billed using NOC codes that 

would otherwise meet the criteria set 

forth in section 3113(a)(2) for being a 

complex diagnostic laboratory test 

under the Demonstration. However, we 

believe that no more than nine entities 

will be eligible to meet those criteria, 

and therefore, while the aforementioned 

requirement is subject to the Paperwork 

Reduction Act (PRA) of 1995, the 

associated burden is exempt under 5 

CFR 1320.3(c)(4). This will affect less 

than 10 entities in a 12-month period. 

Consequently, notice need not be 

reviewed by the Office of Management 

and Budget under the authority of the 

PRA. 

Dated: May 4, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–16721 Filed 7–1–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0376] 

Draft Guidance for Industry; Dietary 

Supplements: New Dietary Ingredient 

Notifications and Related Issues; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Dietary Supplements: 

New Dietary Ingredient Notifications 

and Related Issues.’’ The draft guidance, 

when finalized, will assist industry in 

deciding when a premarket safety 

notification for a dietary supplement 

containing a new dietary ingredient 

(NDI) is necessary and in preparing 

premarket safety notifications (also 

referred to as ‘‘NDI notifications’’). 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on the draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by October 3, 

2011. 

ADDRESSES: Submit written requests for 

single copies of this draft guidance to 

the Office of Nutrition, Labeling, and 

Dietary Supplements, Center for Food 

Safety and Applied Nutrition (HFS– 

850), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740. Send one self-addressed 

adhesive label to assist that office in 

processing your requests. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Corey Hilmas, Center for Food Safety 

and Applied Nutrition (HFS–850), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

240–402–2375. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Dietary Supplements: New Dietary 

Ingredient Notifications and Related 

Issues.’’ This draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115(g)(2)). 

This draft guidance is intended to 

assist industry in deciding when a 

premarket safety notification for a 

dietary supplement containing an NDI is 

necessary and in preparing NDI 

notifications. The draft guidance 

discusses in question and answer format 

FDA’s views on what qualifies as an 

NDI, when an NDI notification is 

required, the procedures for submitting 

an NDI notification, the types of data 

and information that manufacturers and 

distributors should consider when they 

evaluate the safety of a dietary 

supplement containing an NDI, and 

what should be included in an NDI 

notification. In addition, the draft 

guidance contains questions and 

answers about parts of the dietary 

supplement definition that can affect 

whether a particular substance may be 

marketed as a dietary ingredient in a 

dietary supplement. 

On October 25, 1994, the Dietary 

Supplement Health and Education Act 

of 1994 (DSHEA) (Pub. L. 103–417) was 

signed into law. DSHEA amended the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) by adding, among other 

provisions, (1) Section 201(ff) (21 U.S.C. 

321(ff)), which defines the term ‘‘dietary 

supplement’’ and (2) section 413 (21 

U.S.C. 350b), which defines the term 

‘‘new dietary ingredient’’ and requires 

the manufacturer or distributor of an 

NDI, or of the dietary supplement that 

contains the NDI, to submit a premarket 

notification to FDA at least 75 days 

before introducing the supplement into 

interstate commerce or delivering it for 

introduction into interstate commerce, 

unless the NDI and any other dietary 

ingredients in the dietary supplement 

‘‘have been present in the food supply 

as an article used for food in a form in 

which the food has not been chemically 

altered’’ (section 413(a)(1)). The 

notification must contain the 

information, including any citation to 

published articles, which is the basis on 

which the manufacturer or distributor of 

the NDI or dietary supplement has 

concluded that the dietary supplement 

containing the NDI will reasonably be 


srobinson on DSK4SPTVN1PROD with NOTICES