Medlearn
Matters…Information for Medicare
Providers
(Issued by the Centers for
Medicare & Medicaid
Services)
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MMA - Coverage
of Routine Costs of Clinical Trials Involving
Investigational Device Exemption (IDE) Category A
Devices
Provider Types Affected
Physicians and providers
Provider Action Needed
Impact to You
Effective for routine costs incurred on or after January
1, 2005, Medicare will cover the routine costs of
clinical trials involving Investigational Device
Exemption (IDE) Category A devices (used in the
diagnosis, monitoring, or treatment of an immediately
life-threatening disease or condition).
What You Need to Know
This
extension of coverage refers to the routine services
performed for such clinical trials. The Category
A device itself remains noncovered.
Background
Prior to the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA), the Centers for Medicare
& Medicaid Services (CMS) limited coverage of
clinical trials to:
- IDE Category B trials (21 CFR 405.201); and
- Routine costs for qualifying clinical trials
(National Coverage Determinations (NCD) Manual
310.1).
The MMA (Section 731(b)) expands the ability of CMS to
cover costs in clinical trials by authorizing coverage of
routine costs in certain clinical trials involving IDE
Category A devices effective for routine costs incurred
on or after January 1, 2005.
This extension of coverage refers to the
routine services performed for such a trial, and the
Category A device itself remains noncovered.
Category A (experimental/investigational) devices are
innovative medical devices about which the Food and Drug
Administration (FDA) has major questions regarding safety
and effectiveness. For a trial to qualify for payment of
routine costs, it must meet certain criteria established
by the Secretary of the Department of Health and Human
Services to ensure that the trial conforms to appropriate
scientific and ethical standards.
In addition, the MMA established additional criteria
for trials initiated before January 1, 2010, to ensure
that the devices involved in these trials be intended for
use in the:
1) Diagnosis;
2) Monitoring; or
3) Treatment of an immediately life-threatening
disease or condition (“a stage of a disease in
which there is a reasonable likelihood that death will
occur within a matter of months or in which premature
death is likely without early treatment).
Providers participating in the clinical trial are
responsible for furnishing all information the Medicare
contractor (carrier or fiscal intermediary) deems
necessary for coverage determination and claims
processing regarding:
- The device;
- The clinical trial; and
- The participating Medicare beneficiaries.
Also, the provider must contact their local Medicare
carrier or intermediary before billing for this
service.
Billing Instructions
For
routine services performed in a clinical trial where a
Category A device is used for a patient with a
life-threatening condition:
- Physicians billing with the CMS Form
1500 must place the IDE number of the Category
A device in Item 23;
- Physicians billing electronically
must place the IDE number on the 2300 Investigational
Device Exemption Number REF segment, data element REF02
(REF01=LX) of the 837p; and
- Hospitals must place the Category
A IDE number on the 837i electronic claim format in
2300 Investigational Device Exemption Number REF
Segment, data element REF02 (REF01=LX). If billing on
the CMS-1450 paper form, the IDE number must be in Form
Locator 43.
- All providers should place the QV
modifier on the claim to reflect routine costs in a
clinical trial associated with an IDE Category A
device. Note, however, that CMS is working to obtain
another modifier that will be required in addition to
the QV modifier. Further news will be provided on that
modifier once CMS receives it.
- All providers should also note
that Medicare will continue to deny claims submitted
for the IDE Category A device itself.
Implementation
The
implementation date for this instruction is January 3,
2005.
Additional Information
For
complete details, please see the official instruction
issued to your carrier/intermediary regarding this
change. That instruction may be viewed by going to:
http://www.cms.hhs.gov/Transmittals/downloads/R131OTN.pdf
.
If you have any questions, please contact your
carrier/intermediary at their toll-free number, which may
be found at: http://www.cms.hhs.gov/MedlearnProducts/downloads/CallCenterTollNumDirectory.pdf
.
Disclaimer
Medlearn Matters articles are
prepared as a service to the public and are not intended
to grant rights or impose obligations. Medlearn Matters
articles may contain references or links to statutes,
regulations, or other policy materials. The information
provided is only intended to be a general summary. It is
not intended to take the place of either the written law
or regulations. We encourage readers to review the
specific statutes, regulations, and other interpretive
materials for a full and accurate statement of their
contents.
For more information, visit the Medlearn Matters Web
page at: http://www.cms.hhs.gov/MedlearnMattersArticles/.
Pub. 100-20, Transmittal # 131, CR # CR 3548
Medlearn Matters Number: MM 3548
Effective Date: January 1, 2005
Implementation Date: January 3, 2005
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