[Federal Register Volume 76, Number 128 (Tuesday, July 5, 2011)]
[Notices]
[Pages 39110-39111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-16721]
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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 [email protected].
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