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A. Part A Payment for L-Dopa and Associated Inpatient Hospital Services

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A hospital stay and related ancillary services for the administration of
L-Dopa are covered if medically required for this purpose. Whether a drug
represents an allowable inpatient hospital cost during such stay depends on
whether it meets the definition of a drug in 1861(t) of the Act; i.e., on its
inclusion in the compendia named in the Act or approval by the hospital's
pharmacy and drug therapeutics (P&DT) or equivalent committee. (Levodopa
(L-Dopa) has been favorably evaluated for the treatment of Parkinsonism by
A.M.A. Drug Evaluations, First Edition 1971, the replacement compendia for
"New Drugs.")

Inpatient hospital services are frequently not required in many cases when
L-Dopa therapy is initiated. Therefore, determine the medical need for
inpatient hospital services on the basis of medical facts in the individual
case. It is not necessary to hospitalize the typical, well-functioning,
ambulatory Parkinsonian patient who has no concurrent disease at the start of
L-Dopa treatment. It is reasonable to provide inpatient hospital services for
Parkinsonian patients with concurrent diseases, particularly of the
cardiovascular, gastrointestinal, and neuropsychiatric systems. Although many
patients require hospitalization for a period of under 2 weeks, a 4-week
period of inpatient care is not unreasonable.

Laboratory tests in connection with the administration of L-Dopa - The tests
medically warranted in connection with the achievement of optimal dosage and
the control of the side effects of L-Dopa include a complete blood count,
liver function tests such as SGOT, SGPT, and/or alkaline phosphatase, BUN or
creatinine and urinalysis, blood sugar, and electrocardiogram.

Whether or not the patient is hospitalized, laboratory tests in certain cases
are reasonable at weekly intervals although some physicians prefer to perform
the tests much less frequently.

Physical therapy furnished in connection with administration of L-Dopa -
Where, following administration of the drug, the patient experiences a
reduction of rigidity which permits the reestablishment of a restorative goal
for him/her, physical therapy services required to enable him/her to achieve
this goal are payable provided they require the skills of a qualified physical
therapist and are furnished by or under the supervision of such a therapist.
However, once the individual's restoration potential has been achieved, the
services required to maintain him/her at this level do not generally require
the skills of a qualified physical therapist. In such situations, the role of
the therapist is to evaluate the patient's needs in consultation with his/her
physician and design a program of exercise appropriate to the capacity and
tolerance of the patient and treatment objectives of the physician, leaving to
others the actual carrying out of the program. While the evaluative services
rendered by a qualified physical therapist are payable as physical therapy,
services furnished by others in connection with the carrying out of the
maintenance program established by the therapist are not.

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B. Part A Reimbursement for L-Dopa Therapy in Skilled Nursing Facilities
(SNFs)

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Initiation of L-Dopa therapy can be appropriately carried out in the SNF
setting, applying the same guidelines used for initiation of L-Dopa therapy in
the hospital, including the types of patients who should be covered for
inpatient services, the role of physical therapy, and the use of laboratory
tests. (See subsection A.)

Where inpatient care is required and L-Dopa therapy is initiated in the SNF,
limit the stay to a maximum of 4 weeks; but in many cases the need may be no
longer than 1 or 2 weeks, depending upon the patient's condition. However,
where L-Dopa therapy is begun in the hospital and the patient is transferred
to an SNF for continuation of the therapy, a combined length of stay in
hospital and SNF of no longer than 4 weeks is reasonable (i.e., 1 week
hospital stay followed by 3 weeks SNF stay; or 2 weeks hospital stay followed
by 2 weeks SNF stay; etc.). Medical need must be demonstrated in cases where
the combined length of stay in hospital and SNF is longer than 4 weeks. The
choice of hospital or SNF, and the decision regarding the relative length of
time spent in each, should be left to the medical judgment of the treating
physician.

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C. L-Dopa Coverage Under Part B

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Part B reimbursement may not be made for the drug L-Dopa since it is a self-
administrable drug. However, physician services rendered in connection with
its administration and control of its side effects are covered if determined
to be reasonable and necessary. Initiation of L-Dopa therapy on an outpatient
basis is possible in most cases. Visit frequency ranging from every week to
every 2 or 3 months is acceptable. However, after half a year of therapy,
visits more frequent than every month would usually not be reasonable.