Medicare Program; Section 3113: The Treatment of Certain Complex Diagnostic Laboratory Tests Demonstration, 39110-39111 [2011-16721]
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39110
Federal Register / Vol. 76, No. 128 / Tuesday, July 5, 2011 / Notices
meetings. Please visit our Web site at
https://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
[CMS–5058–N]
Medicare Program; Section 3113: The
Treatment of Certain Complex
Diagnostic Laboratory Tests
Demonstration
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
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.
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
Supporting information
should be mailed to the following
address: Centers for Medicare &
Medicaid Services, Attention: Linda R.
Lebovic, 7500 Security Boulevard, Mail
VerDate Mar<15>2010
17:58 Jul 01, 2011
Jkt 223001
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
Centers for Medicare & Medicaid
Services
ADDRESSES:
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.
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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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
https://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,
E:\FR\FM\05JYN1.SGM
05JYN1
Federal Register / Vol. 76, No. 128 / Tuesday, July 5, 2011 / Notices
and Budget under the authority of the
PRA.
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: https://
www.cms.gov/DemoProjectsEvalRpts/
MD/
itemdetail.asp?itemID=CMS1240611.
srobinson on DSK4SPTVN1PROD with NOTICES
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
VerDate Mar<15>2010
17:58 Jul 01, 2011
Jkt 223001
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.
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 https://
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
SUMMARY:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
39111
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
E:\FR\FM\05JYN1.SGM
05JYN1
]]>Agencies
[Federal Register Volume 76, Number 128 (Tuesday, July 5, 2011)]
[Notices]
[Pages 39110-39111]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16721]
-----------------------------------------------------------------------
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 https://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: https://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
