### 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,


### 39111 Federal Register / Vol. 76, No. 128 / Tuesday, July 5, 2011 / Notices

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