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CMS Manual System Department of Health & Human Services (DHHS)
Pub. 100-04 Medicare Claims Processing
Centers for Medicare & Medicaid Services (CMS)
Transmittal 487
I. SUMMARY OF CHANGES: No change. This is a manualization of instructions in
the MCM and previously issued PMs.
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MANUALIZATION/CLARIFICATION - EFFECTIVE/IMPLEMENTATION
DATES: Not Applicable.
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Disclaimer for manual changes only: The revision date and transmittal number
apply to the red italicized material only. Any other material was previously
published and remains unchanged. However, if this revision contains a table of
contents, you will receive the new/revised information only, and not the entire
table of contents.
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II. CHANGES IN MANUAL INSTRUCTIONS: (N/A if manual not updated.) (R = REVISED,
N = NEW, D = DELETED) - (Only One Per Row.)
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R/N/D CHAPTER/SECTION/SUBSECTION/TITLE
N Chapter 32, Section 69.0 - Qualifying Clinical Trials
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III. FUNDING: Medicare contractors shall implement these instructions within
their current operating budgets.
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IV. ATTACHMENTS:
X Business Requirements
X Manual Instruction
- Confidential Requirements
- One-Time Notification
- Recurring Update Notification
.. *Unless otherwise specified, the effective date is the date of service.
CMS has issued a National Coverage Determination (NCD) which allows Medicare
coverage for the routine cost of qualifying clinical trial services as well as
reasonable and necessary items and services used to diagnose and treat
complications arising from participation in all clinical trials.
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B. Policy:
This is a manualization of instructions in MCM and previously issued PMs.
There are no changes.
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C. Provider Education: None.
Contractors shall implement these previously
issued requirements as outlined in previously
issued CR 1424 & 1637, and Transmittal #
1770, dated September 18, 2002.
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Responsibility ("X" indicates the columns that apply)
FI............................X
RHHI
Carrier.......................X
.. DMERC
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Shared System Maintainers
FISS
MCS
VMS
CWF
Other
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III. SUPPORTING INFORMATION AND POSSIBLE DESIGN CONSIDERATIONS
X-Ref Requirement # Instructions N/A
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B. Design Considerations:
X-Ref Requirement # Recommendation for Medicare System Requirements N/A
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C. Interfaces: N/A
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D. Contractor Financial Reporting /Workload Impact: N/A
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E. Dependencies: N/A
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F. Testing Considerations: N/A
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IV. SCHEDULE, CONTACTS, AND FUNDING
Chapter 32 - Billing Requirements for Special Services
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Table of Contents
(Rev. 487, 03-04-05)
69.0 - Qualifying Clinical Trails
69.1 - General
69.2 - Payment for Qualifying Clinical Trial Services
69.3 - Medical Records Documentation Requirements
69.4 - Local Medical Review Policy
69.5 - Billing Requirements - General
69.6 - Billing Requirements for Dates of Service on or after January 1, 2002
69.7 - Billing Requirements for Services Furnished to Healthy Control Group
Volunteers Participating in Diagnostic Trials
69.8 - Handling Erroneous Denials of Qualifying Clinical Trial Services
69.9 - Processing Fee for Service Claims for Covered Clinical Trial Services
Furnished to Managed Care Enrollees
69.10 - CWF Editing Of Clinical Trial Claims For Managed Care Enrollees
69.11 - Resolution of CWF UR 5232 Rejects
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69.0 - Qualifying Clinical Trials
(Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A)
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69.1 - General
(Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A)
CMS has issued a National Coverage Determination (NCD) which allows Medicare
coverage for the routine costs of qualifying clinical trial services as well as
reasonable and necessary items and services used to diagnose and treat
complications arising from participation in all clinical trials. The coverage
requirements for routine costs of qualifying clinical trial services are
contained in section 310.1 of the National Coverage Determinations Manual.
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69.2 - Payment for Qualifying Clinical Trial Services
(Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A)
For dates of service on or after September 19, 2000, pay for covered services
furnished to beneficiaries participating in qualifying clinical trials.
Payment is based on the payment methodology applicable for the service that was
furnished (e.g., physician fee schedule, lab fee schedule, DME fee schedule,
reasonable charge, etc.). With the exception of managed care enrollees,
applicable deductibles and coinsurance rules apply to clinical trial items and
services. The Part A and Part B deductibles are assumed to be met for covered
clinical trial services billed on a fee service basis for managed care
enrollees.
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69 .3 - Medical Records Documentation Requirements
(Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A)
The billing provider must include in the beneficiary's medical record the
following information: trial name, sponsor, and sponsor-assigned protocol
number. This information does not need to be submitted with the claim but must
be provided if requested for medical review.
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69.4 - Local Medical Review Policy
(Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A)
Do not develop new or revised LMRPs for clinical trial services. Clinical trial
services that meet the requirements of the NCD are considered reasonable and
necessary.
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69.5 - Billing Requirements - General
(Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A)
Instruct physicians, suppliers and hospitals to enter clinical trial and
non-clinical trial services on separate line items when billing both types of
services on the same claim. For services that require a Certificate of Medical
Necessity (CMN), continue to require CMNs. Items and services provided free of
charge by research sponsors may not be billed to Medicare.
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69.6 - Billing Requirements for Dates of Service on or after January 1, 2002
(Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A)
For services furnished on or after January 1, 2002, providers are required to
submit the following information depending on the type of service and
contractor (fiscal intermediary or carrier) to which they are billing:
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Fiscal intermediary
Condition code 30
(for all types of service)
ICD-9 diagnosis code V70.7
(as secondary diagnosis for all
types of service)
.. QV modifier
(outpatient types of services
only)
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Carrier
QV modifier
NOTE: Reporting of ICD-9
diagnosis code V70.7 is not
required unless section 69.7
applies.
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69.7 - Billing Requirements for Services Furnished to Healthy Control
Group Volunteers Participating in Diagnostic Trials
(Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A)
Routine costs submitted to carriers for services furnished to Medicare
beneficiaries, who are healthy, control group volunteers participating in
qualifying diagnostic clinical trials, are to be coded/billed in the following
manner:
The "QV" procedure code modifier is reported at the line item level.
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Diagnosis code V70.7 (Examination of participant in clinical
trial) is reported as the primary diagnosis
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If the QV modifier is billed and diagnosis code V70.7 is submitted to carriers
as a secondary rather than the primary diagnosis, do not consider the service
as having been furnished to a healthy, control group, diagnostic trial
volunteer. Instead, process the service as a therapeutic clinical trial
service. Routine costs submitted to FIs for services furnished to Medicare
beneficiaries, who are healthy, control group volunteers participating in
qualifying diagnostic clinical trials, are to be coded/billed on the in the
following manner:
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69.8 - Handling Erroneous Denials of Qualifying Clinical Trial Services
(Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A)
If a service Medicare covers was billed with the appropriate clinical trial
coding but was inadvertently denied (e.g., for medical necessity or
utilization) and is subsequently brought to your attention, adjust the denied
claim. If the denied services weren't properly coded as clinical trial
services, instruct the provider to resubmit the service on a new claim with
appropriate clinical trial coding.
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69.9 - Processing Fee for Service Claims for Covered Clinical Trial Services
Furnished to Managed Care Enrollees
(Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A)
For dates of service on or after September 19, 2000, and until notified
otherwise by CMS, Medicare contractors will pay for covered clinical trial
services furnished to beneficiaries enrolled in managed care plans. Providers
who furnish covered clinical trial services to managed care beneficiaries must
be enrolled with Medicare in order to bill on a fee-for-service basis.
Providers that wish to bill fee for service but have not enrolled with Medicare
must contact their local carrier, intermediary, regional home health
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intermediary or National Supplier Clearinghouse, as appropriate, to obtain an
enrollment application.
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Determine payment for covered clinical trial services furnished to
beneficiaries enrolled in managed care plans in accordance with applicable fee
for service rules, except that beneficiaries are not responsible for the Part A
or Part B deductibles (i.e., assume the Part A or Part B deductible has been
met). Managed care enrollees are liable for the coinsurance amounts applicable
to services paid under Medicare fee for service rules.
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The clinical trial coding requirements for managed care enrollee claims are the
same as those for regular Medicare fee for service claims.
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69.10 - CWF Editing Of Clinical Trial Claims For Managed Care Enrollees
(Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A)
Submit clinical trial services for managed care enrollees to CWF for payment
approval. CWF will not reject clinical trial claims for managed care enrollees
when all services on the claim transaction record are coded as clinical trial
services and the date(s) of service is (are) on or after September 19, 2000.
In addition, CWF will not apply Part B deductible to clinical trial claims for
managed care enrollees (i.e., CWF will process clinical trial services for
managed care enrollees as if the Part B deductible has already been met).
.. 69.11 - Resolution of CWF UR 5232 Rejects
(Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A)
If you send a claim transaction to CWF that includes both clinical and
non-clinical trial services for a managed care enrollee, the entire claim will
be rejected with the UR 5232 error code. When you receive a UR 5232 error code
split the claim and resubmit the clinical trial portion to CWF. Process the
non-clinical trial portion of the rejected claims in the same manner that other
non-clinical trial fee for service claims for managed care enrollees are
handled.