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CPT codes,
descriptions and other data only are copyright 2007 American Medical
Association (or such other date of publication of CPT). All Rights
Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology,
(CDT) (including procedure codes, nomenclature, descriptors and other data
contained therein) is copyright by the American Dental Association. © 2002,
2004 American Dental Association. All rights reserved. Applicable
FARS/DFARS apply.
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Title XVIII of the
Social Security Act, Section 1862 (a)(1)(A). This
section excludes coverage of items or services that are not reasonable and
necessary for the diagnosis or treatment of illness or injury or to improve
the functioning of a malformed body member.
Title XVIII of the Social Security Act, Section 1862 (a)(7).
This section prohibits Medicare payment for any expenses on items and
services incurred for routine physical examinations.
Title XVIII of the Social Security Act, Section 1833 (e). This section
prohibits Medicare payment for any claim that lacks the necessary
information to process the claim.
CMS Pub 100-2, 15, §50, 17-§10, Drugs and biologicals.
CMS Pub 100-2, 1 §30
CMS Pub 100-2, 16 §20
Program Integrity Manual (PIM), Section 2.3.2.1. Evidence supporting LMRP.
Program Integrity Manual (PIM), Section 2.3.2.3. Section addressing
alternative services be tried first.
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The Least You Need to Know
Riverbend will cover any FDA approved drug for both its labeled and
off-label indications unless an off-label indication is specifically
precluded in another LMRP.Riverbend will not
cover Investigational New Drugs (IND). It will not cover investigational
uses of established drugs except for chemotherapeutic agents used in a
cancer center protocol for the treatment of a malignant disease.
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The Off-label use of a drug is the use of drugs for an indication, dosage
form, dose regimen, population or other use parameter not included as an
indication on the drug’s label as approved by the FDA.
Medicare recognizes off-label use of FDA approved drugs. Medicare
guidelines dictate that certain medical services, which are deemed
reasonable and necessary for the diagnosis or treatment of illness or
injury or to improve the functioning of a malformed body member, are
covered services [SSA section 1862(a)(1)]. Coverage of off-label FDA
approved drugs is determined taking into consideration the major drug
compendia, authoritative medical literature and /or generally accepted
medical practice in the community and as long as FDA has not specified such
use as non-approved (CMS Pub 100-2, 1 §30) (MCM 2049).
This policy defines what may be covered by Medicare, outlines the
requirements to consider off-label drug use and is not intended to restrict
what providers may provide nor what patients may receive. Physicians who chooses to use a product for an
indication not in the approved labeling have the responsibility to be well
informed about the product, to base its use on firm scientific rationale
and on sound medical evidence, and to maintain records of the product's use
and effects.
Investigational New Drugs (IND)
or Investigational Use of Marketed Drugs, Biologics and Medical Devices
The investigational use of approved, marketed products differs from”
Off-Label Drug Use”. "Investigational use" suggests the use of an
approved product in the context of a clinical study protocol [see 21 CFR
312.3(b)]or the use of a product for an indication
that is not supported by the current body of medical literature.
Investigational New Drugs (IND)
or investigational use of newly approved or established drugs is not
covered by Medicare (CMS Pub 100-2, 1 §30). However, Riverbend does not
generally consider the use of an established chemotherapeutic agent to be
investigational when it is used under an established cancer center research
protocol in the treatment of a malignancy for which it has not yet been
approved unless that use is specified listed as I&E in another LMRP.
FDA-approved drugs used for indications other than those specified on
the FDA-approved labeling drugs will be covered if:
- The use is listed as “off-label use” in
the USPDI.
FDA-approved drugs used for indications other than those specified on
the FDA-Approved labeling <Imay be
covered if:
- The use is supported (at a possibly
effective level or higher) in one or more citations in any of the
following drug compendia AND the use is not listed as ”not indicated”:
- American Hospital Formulary Service Drug Information
(AHFS)
- American Medical Association Drug
Evaluations
- A decision to support the use has been
made by one of the above compendia and is forthcoming, with findings
based upon reports in one of the following peer-reviewed medical
journals. (This applies only when an unlabeled use does not appear in
any of the compendia or is listed as insufficient or investigational):
- American Journal of Medicine
- Annals of Internal Medicine
- The Journal of the American Medical
Association
- The Journal of Clinical Oncology
- Blood
- Journal of the National Cancer Institute
- The New England
Journal of Medicine
- British Journal of Cancer
- British Journal of Hematology
- British Medical Journal
- Cancer
- Drugs
- European Journal of Cancer
- Lancet
- Leukemia
- It is determined by the contractor to be
medically accepted generally as safe and effective for the particular
use (MCM 2049).
Off-label uses of drugs used in an anti-cancer chemotherapeutic regimen are
covered for a medically accepted indication as defined in CMS Pub 100-2,
15, §50.4-50.4.4.1, 100-4, 18-§10.2
Indications not listed as labeled or off-labeled in the USPDI may require
hard copy documentation at the time of claim submission.
A drug is not covered if a use is identified as:
- Not indicated by CMS or the FDA;
- Not indicated in at least one of the two
major compendia mentioned;
- Not safe and effective, based on peer
reviewed medical literature;
- Not supported by any of above criteria
and/or requirements
Other Comments
1. Determinations as to whether medication is reasonable and necessary for
an individual patient should be made on the same basis as all other such
determinations. [CMS Pub 100-2, 1 §30 guidelines in which medications would
not be reasonable and necessary].
2. Peer reviewed medical literature does not include in-house publications
of pharmaceutical manufacturing companies or abstracts (including meeting
abstracts).
3. An ABN (Advance Beneficiary Notice) may be provided to the patient when
the provider deems the services is not medically necessary or exceeds
acceptable standard of medical practice as indicated in the label and
off-label drug compendia.
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