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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)(7)
This section excludes routine physical examinations.
• Title XVIII of the Social Security Act, Section 1862 (a)(1)(A)
This section allows coverage and payment for only those services considered
medically reasonable and necessary.
• 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.
• Title XVIII of the Social Security Act, Section 1861(s)(2)(A)
This section allows coverage and payment for services and supplies
(including drugs and biologicals which are not usually self-administered by
the patient) furnished as an incident to a physician's professional
service, of kinds which are commonly furnished in physicians' offices and
are commonly either rendered without charge or included in the physicians'
bills.
• CMS Manual System, Pub 100-2, Medicare Benefit Policy, Chapter 15,
Section 17. (http://www.cms.hhs.gov/manuals/)
This section addresses Medicare coverage of drugs and biologicals.
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THE LEAST YOU NEED TO
KNOW
Alefacept is covered only for IV administration for moderate to severe
chronic plaque psoriasis requiring systemic therapy, for courses of
treatment of 12 weeks duration occuring at no less than 7 month intervals.
OVERVIEW
Psoriasis is a chronic immune-mediated disease of the skin affecting an
estimated 2% of the population. It has been treated with topical, photo and
systemic therapies. The topical therapies include corticosteroids,
anthralin and tars, calcipotriene, tazarotene and salicylic acid. Phototherapies have generally involved UVA or UVB, but now also
includes laser therapy for localized lesions. Systemic therapies
include use of drugs such as methotrexate, cyclosporine, retinoids and now
alefacept. Some of the therapies are used in combination so as to minimize
toxicities while maximizing response, or as rotational therapy.
Alefacept is a human fusion protein directed at T-cells expressing the CD2
antigen, preventing lymphocyte activation. These lymphocytes are involved
in the inflammatory process in psoriatic lesions. The drug is administered
intramuscularly or intravenously weekly for 12 weeks. Because alefacept may
reduce circulating CD4+ and CD8+ T-lymphocytes, weekly CD4+ tests are
required for monitoring while administering the drug. Alefacept has been
approved by the FDA for treatment of adult patients with moderate to severe
chronic plaque psoriasis who are candidates for systemic therapy or
phototherapy.
Alefacept is administered as an intramuscular injection of 15mg, or as an
intravenous bolus injection of 7.5mg over five (5) seconds.
Psoriasis severity is categorized by body surface area (National Psoriasis
Foundation) as:
*Mild: covers less than 2% of the body
*Moderate: covers 2-10% of the body
*Severe: covers more than 10% of the body
Psoriasis of the palms can be severe even though the percentage of the body
surface area covered may be small.
INDICATIONS
1. Alefacept is indicated for the treatment of moderate to severe chronic
plaque psoriasis in patients who have:
-- received or are candidates for phototherapy or systemic therapy AND
-- failed to respond to topical therapy, have a medical contraindication to
such therapy, or a basis for a reasonable medical expectation exists that
this therapy would not be effective.
2. In case of a relapse, the treatment may be repeated if:
--the initial course of therapy resulted in remission, AND
--a minimum of 12 weeks has elapsed since the completion of the previous
treatment.
3. Other systemic treatments must have been considered by the physician and
discussed with the patient, but are not required to have been tried.
LIMITATIONS
1. Alefacept is not indicated for treatment in patients who have forms of
psoriasis other than chronic plaque psoriasis.
2. Alefacept will be considered not reasonable or necessary in patients:
a. Who have not previously received topical therapy, or for whom there is
no medical reason why this therapy is not expected to be of value in
controlling the beneficiary’s psoriasis.
b. Who are receiving it in combination with other systemic therapies, as
these uses are considered investigational.
However, combination therapy would be acceptable during the initial period
in which alefacept would not be expected to have demonstrable clinical
effects. This is to allow for control of potential flare of the inherent
psoriasis disease process.
c. Who receive it as a second course of treatment, after failure of an
initial course of therapy (failure will be defined as less than 50%
improvement as assessed and documented by the physician).
d. In whom the CD4+ count is below 250cells/cubic millimeter at the time of
administration, nor for subsequent doses in any patient in whom the CD4+
count is less than 250cells/cubic millimeter for a month.
e. In whom the administration is contraindicated because of clinically
significant infection, malignancy, and history of systemic malignancy or
concurrent treatment with other immunosuppressive therapies (including
phototherapy).
3. CD4+ lymphocyte counts must be drawn with results available to the
treating physician prior to the administration of each treatment.
4. Other uses of alefacept (e.g. for other medical conditions) are
considered investigational and are not covered.
LEAST COSTLY ALTERNATIVE
Medicare will reimburse alefacept 7.5mg administered intravenously based
upon its AWP and the Single Drug Pricer schedule. If administered
intramuscularly (15mg), it will be reimbursed under the Least Costly
Alternative at the price of the 7.5mg dose, unless it was medically
necessary to administer the drug intramuscularly (i.e., intravenous access
was NOT possible in ANY peripheral veins following multiple attempts).
Patient or physician preference for route of administration is not
considered a medical necessity. Documentation of the medical necessity for
intramuscular administration will be needed to adjudicate the claim.
Payments will be denied for the additional expense of the more costly dose
as not medically reasonable and necessary. As with any submitted charge
that is considered not medically reasonable and necessary, the beneficiary
can be held liable for the denied charge if an Advanced Beneficiary Notice
(ABN) is signed before each injection. The beneficiary’s liability,
however, must not exceed the difference in Medicare allowance between the
two doses.
Any time the production of intravenous formulation of the alefacept is
suspended, and therefore it is not available, the Least Costly Alternative
(LCA) policy would not be applied. Medication would be reimbursed according
to CMS instructions based upon the intramuscular formulation only. The
Least Costly Alternative re-activates as soon as intravenous alefacept
becomes available. Failure of a facility to stock the IV formulation does
NOT constitute non-availablity and does NOT suspend the LCA clause.
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