Does Medicare cover Carnitor® Injection for hemodialysis patients?
Yes. On November 8, 2002, CMS issued a Program Memorandum to
Intermediaries and Carriers on "Levocarnitine for use in the
treatment of Carnitine Deficiency in ESRD Patients," which contains
the payment instructions for intravenous levocarnitine for ESRD
Patients. The program memorandum applies to all fiscal intermediaries
and is effective as of January 1, 2003.
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Where can a copy of the CMS Program Memorandum be
obtained?
A copy of the CMS program memorandum "Levocarnitine for use in
the treatment of Carnitine Deficiency in ESRD Patients"
(Transmittal AB-03-130) can be obtained from your Sigma-Tau sales
representative, by contacting the Carnitor® Injection Reimbursement Hotline at 1-800-490-3262 or
sigmataureimbursement@unitedbiosource.com. It is also available at
the CMS web page: http://www.cms.hhs.gov/Transmittals/downloads/AB03130.pdf
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Are all dialysis patients covered under the CMS
program memorandum?
No. Intravenous levocarnitine will only be covered for those ESRD
patients who have been on dialysis for a minimum of three months, have a
documented plasma free carnitine level of < 40 micrcomol/L
(determined by a professionally accepted method as recognized in current
literature), along with signs and symptoms of:
- Erythropoietin-resistant anemia (persistent hematocrit < 30
percent with treatment) that has not responded to standard
erythropoietin dosage (that which is considered clinically appropriate
to treat the particular patient) with iron replacement, and for which
other causes have been investigated and adequately treated OR;
- Hypotension on hemodialysis that interferes with delivery of the
intended dialysis despite application of usual measures deemed
appropriate (e.g., fluid management). Such episodes of hypotension must
have occurred during at least 2 dialysis treatments in a 30-day
period.
Continued use of levocarnitine will not be covered if improvement has
not been demonstrated within 6 months of initiation of treatment.
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What documentation is needed for coverage and
reimbursement of Carnitor® Injection?
At a minimum, there are four essential items that must documented.
These include:
- Plasma free carnitine level < 40 micromol/L and date
- MD order for medication and date
- Progress note with rationale when starting therapy
- Progress note with rationale within six months of initiation of
treatment
Note: In the event of an audit, the payer will
request documentation for a specific timeframe; however, additional
documentation that supports the NCD must also be submitted. This may
include, but is not limited to, previous progress notes, orders, labs,
flow sheets, care plans, etc.
For sample progress notes, please click the following link:
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How often does the plasma free carnitine level need
to be drawn?
The plasma free carnitine level should be drawn pre-dialysis and
prior to the initiation of Carnitor® Injection therapy.
The plasma free carnitine level needs to be drawn ONLY prior to the
first administration of Carnitor® Injection to satisfy
CMS reimbursement requirements.
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What are the billing codes for
Carnitor® Injection?
The J-code for Carnitor® Injection, 1 gm/5 ml is
"J1955" and the revenue code is "0636."
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What are the ICD-9-CM diagnosis codes for Medicare
covered conditions?
| DCD and Erythropoietin-resistant Anemia:
|
|
| End Stage Renal Disease |
585.6 |
| Iatrogenic Carnitine Deficiency
|
277.83 |
| Anemia in Chronic Kidney Disease
|
285.21 |
| DCD and Intradialytic Hypotension:
|
|
| End Stage Renal Disease |
585.6 |
| Iatrogenic Carnitine Deficiency
|
277.83 |
| Hypotension of Hemodialysis |
458.21 |
The
physician is responsible for assuring the accuracy in the selection of
the appropriate code that reflects the patient's condition.
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What are the billing codes for a plasma free
carnitine test?
The HCPCS code for the plasma free carnitine test is
"82379" and the revenue code is "0304."
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What is an ADR and what information does my Medicare Fiscal Intermediary (FI) need in response to an ADR?
The purpose of the Additional Development Request (ADR) is to obtain additional information from the provider
while the claim is still active. This request for information is usually in conjunction with the prepayment review process.
The ADR informs providers that they have 30 days to submit documentation to support that services were rendered and medically
necessary. A copy of the ADR letter must be attached to the front of the medical record sent in by the provider. If the
information is not received within the 30-day period, the claim will be denied as not medically necessary due to insufficient
documentation. Providers may have to utilize the appeals process if the claim is denied. The ADR includes the claim date(s) of
service, specific documentation required for the date(s) of service, and where to return the documentation. Please note that in
addition to submitting the specific documentation for the date(s) of service requested, additional documentation supporting the
medical necessity for the initiation of levocarnitine injection should be submitted.
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