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[Federal Register: July 5, 2011 (Volume 76, Number 128)]
[Notices]               
[Page 39110-39111]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05jy11-80]                         

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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.

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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,

[[Page 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
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