Table of Contents
A. Part A Payment for
L-Dopa and Associated Inpatient Hospital Services.--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
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.
See Intermediary Manual, §3101.3 and Carriers Manual, §2050.5.
B. Part A Reimbursement for
L-Dopa Therapy in SNFs.--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.
See Intermediary Manual, §3133.5
C. L-Dopa Coverage Under
Part B.--Part B reimbursement may not be made for the drug L- Dopa since it
is a self-administrable drug. (See Intermediary Manual, §3112.4B; Carriers
Manual, §2050.5B; and Hospital Manual, §230.4B.) 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
45-3 INSULIN SYRINGE
Medical supplies are covered under §1861(s)(2)(A) of the Act only when they
are furnished incident to a physician's professional services. To be covered
under this provision an insulin syringe must have been used by the physician or
under his/her direct personal supervision, and the insulin injection must have
been given in an emergency situation (e.g., diabetic coma).
The use of an insulin syringe by a diabetic would not meet the requirements
of §l861(s)(2)(A) of the Act.
See Intermediary Manual, §3112.4B and Carriers Manual, §2050.
45-4 VITAMIN B12 INJECTIONS TO
STRENGTHEN TENDONS, LIGAMENTS, ETC., OF THE FOOT--NOT COVERED
Vitamin B12 injections to strengthen tendons, ligaments, etc., of the foot are not covered under Medicare because (1) there is no evidence that vitamin B12 injections are effective for the purpose of strengthening weakened tendons and ligaments, and (2) this is nonsurgical treatment under the subluxation exclusion. Accordingly, vitamin B12 injections are not considered reasonable and necessary within the meaning of §1862(a)(1) of the Act.
See Intermediary Manual, §§3101.3 and 3158 and Carriers Manual, §§2050.5 and
45-7 HYDROPHILIC CONTACT LENS FOR
Some hydrophilic contact lenses are used as moist corneal
bandages for the treatment of acute or chronic corneal pathology, such as
bullous keratopathy, dry eyes, corneal ulcers and erosion, keratitis, corneal
edema, descemetocele, corneal ectasis, Mooren's ulcer, anterior corneal
dystrophy, neurotrophic keratoconjunctivitis, and for other therapeutic
Payment may be made under §1861(s)(2) of the Act for a
hydrophilic contact lens approved by the Food and Drug Administration (FDA) and
used as a supply incident to a physician's service. Payment for the lens is
included in the payment for the physician's service to which the lens is
incident. Contractors are authorized to accept an FDA letter of approval or
other FDA published material as evidence of FDA approval. (See §65-1 for
coverage of a hydrophilic contact lens as a prosthetic device.)
See Intermediary Manual, §3112.4 and Carriers Manual,
§§2050.1 and 15010.
45-10 LAETRILE AND RELATED
Laetrile (and the other drugs called by the various terms mentioned below)
have been used primarily in the treatment or control of cancer. Although the
terms "Laetrile," "laetrile," "amygdalin," "Sarcarcinase," "vitamin B-17," and
"nitriloside" have been used interchangeably, the chemical identity of the
substances to which these terms refer has varied.
The FDA has determined that neither Laetrile nor any other drug called by the
various terms mentioned above, nor any other product which might be
characterized as a "nitriloside" is generally recognized (by experts qualified
by scientific training and experience to evaluate the safety and effectiveness
of drugs) to be safe and effective for any therapeutic use. Therefore, use of
this drug cannot be considered to be reasonable and necessary within the meaning
of §1862(a)(1) of the Act and program payment may not be made for its use or any
services furnished in connection with its administration.
A hospital stay only for the purpose of having laetrile (or any other drug
called by the terms mentioned above) administered is not covered. Also, program
payment may not be made for laetrile (or other drug noted above) when it is used
during the course of an otherwise covered hospital stay, since the FDA has found
such drugs to not be safe and effective for any therapeutic purpose.
Autogenous epidural blood grafts are considered a safe and effective remedy
for severe headaches that may occur after performance of spinal anesthesia,
spinal taps or myelograms, and are covered. In the procedure blood is removed
from the patient's vein and injected into his epidural space, to seal the spinal
fluid leak and stop the pain.
45-12 PORCINE SKIN AND GRADIENT
Porcine (pig) skin dressings are covered, if reasonable and necessary for the
individual patient as an occlusive dressing for burns, donor sites of a
homograft, and decubiti and other ulcers.
Gradient pressure dressings are Jobst elasticized heavy duty dressings used
to reduce hypertrophic scarring and joint contractures following burn injury.
They are covered when used for that purpose.
Where a physician establishes an office within a nursing home or other
institution, coverage of services and supplies furnished in the office must be
determined in accordance with the "incident to a physician's professional
service" provision (see Intermediary Manual, §3112.4A or Carriers Manual,
§2050.1), as in any physician's office. A physician's office within an
institution must be confined to a separately identified part of the facility
which is used solely as the physician's office and cannot be construed to extend
throughout the entire institution. Thus, services performed outside the "office"
area would be subject to the coverage rules applicable to services furnished
outside the office setting.
In order to accurately apply the criteria in §3112.4 or §2050.l, give
consideration to the physical proximity of the institution and physician's
office. When his office is located within a facility, a physician may not be
reimbursed for services, supplies, and use of equipment which fall outside the
scope of services "commonly furnished" in physician's offices generally, even
though such services may be furnished in his institutional office. Additionally,
make a distinction between the physician's office practice and the institution,
especially when the physician is administrator or owner of the facility. Thus,
for their services to be covered under the criteria in §3112.4A or §2050.l, the
auxiliary medical personnel must be members of the office staff rather than of
the institution's staff, and the cost of supplies must represent an expense to
the physician's office practice. Finally, services performed by the employees of
the physician outside the "office" area must be directly supervised by
the physician; his presence in the facility as a whole would not suffice to meet
this requirement. (In any setting, of course, supervision of auxiliary
personnel in and of itself is not considered a "physician's professional
service" to which the services of the auxiliary personnel could be an incidental
part, i.e., in addition to supervision, the physician must perform or have
performed a personal professional service to the patient to which the services
of the auxiliary personnel could be considered an incidental part). Denials for
failure to meet any of these requirements would be based on §l861(s)(2)(A) of
Establishment of an office within an institution would not modify rules
otherwise applicable for determining coverage of the physician's personal
professional services within the institution. However, in view of the
opportunity afforded to a physician who maintains such an office for rendering
services to a sizable number of patients in a short period of time or for
performing frequent services for the same patient, claims for physicians'
services rendered under such circumstances would require careful evaluation by
the carrier to assure that payment is made only for services that are reasonable
Cross-refer: Intermediary Manual, §3112.4A; Carriers Manual, §2050.1
Under its Cancer Therapy Evaluation, the Division of Cancer Treatment of the
National Cancer Institute (NCI), in cooperation with the Food and Drug
Administration, approves and distributes certain drugs for use in treating
terminally ill cancer patients. One group of these drugs, designated as Group C
drugs, unlike other drugs distributed by the NCI, are not limited to use in
clinical trials for the purpose of testing their efficacy. Drugs are classified
as Group C drugs only if there is sufficient evidence demonstrating their
efficacy within a tumor type and that they can be safely administered.
A physician is eligible to receive Group C drugs from the Divison of Cancer
Treatment only if the following requirements are
o A physician must be registered with the NCI as an investigator by having completed an FD-Form 1573;
o A written request for the drug, indicating the disease to be treated, must be submitted to the NCI;
o The use of the drug must be limited to indications outlined in the NCI's guidelines; and
o All adverse reactions must be reported to the Investigational Drug Branch of the Division of Cancer Treatment.
In view of these NCI controls on distribution and use of Group C drugs,
intermediaries may assume, in the absence of evidence to the contrary, that a
Group C drug and the related hospital stay are covered if all other applicable
coverage requirements are satisfied.
If there is reason to question coverage in a particular case, the matter
should be resolved with the assistance of the local PSRO, or if there is none,
the assistance of your medical consultants.
Information regarding those drugs which are classified as Group C drugs may
be obtained from:
|Office of the Chief, Investigational Drug Branch|
|Division of Cancer Treatment, CTEP, Landow Building|
|Room 4C09, National Cancer Institute|
|Bethesda, Maryland 20205|
45-17 TRANSFER FACTOR FOR TREATMENT
OF MULTIPLE SCLEROSIS
Transfer factor is the dialysate of an extract from sensitized leukocytes
which increases cellular immune activity in the recipient. It is not covered as
a treatment for multiple sclerosis because its use for the purpose is still
Granulocyte transfusions to patients suffering from severe infection and granulocytopenia are a covered service under Medicare. Granulocytopenia is usually identified as fewer than 500 granulocytes/mm3 whole blood. Accepted indications for granulocyte transfusions include:
o Granulocytopenia with evidence of gram negative
o Granulocytopenia in febrile patients with local progressive infections unresponsive to appropriate antibiotic therapy, thought to be due to gram negative organisms.
45-19 TRANSCUTANEOUS ELECTRICAL
NERVE STIMULATION (TENS) FOR ACUTE POST-OPERATIVE PAIN
The use of transcutaneous electrical nerve stimulation (TENS) for the relief of acute post-operative pain is covered under Medicare. TENS may be covered whether used as an adjunct to the use of drugs, or as an alternative to drugs, in the treatment of acute pain resulting from surgery.
TENS devices, whether durable or disposable, may be used in furnishing this
service. When used for the purpose of treating acute post-operative pain, TENS
devices are considered supplies. As such they may be hospital supplies furnished
inpatients covered under Part A, or supplies incident to a physician's service
when furnished in connection with surgery done on an outpatient basis, and
covered under Part B.
It is expected that TENS, when used for acute post-operative pain, will be
necessary for relatively short periods of time, usually 30 days or less. In
cases when TENS is used for longer periods, contractors should attempt to
ascertain whether TENS is no longer being used for acute pain but rather for
chronic pain, in which case the TENS device may be covered
as durable medical equipment as described in §60-20.
Cross-refer: HCFA Pub. 13-3, §§65-8, 3101.4, 3112.4, 3113; HCFA Pub. 14-3, §§65-8, 2050.1, 2100; HCFA Pub. 10, §§65-8, 210.4, 230, 235.
(EDTA) CHELATION THERAPY FOR TREATMENT OF ATHEROSCLEROSIS
The use of EDTA as a chelating agent to treat atherosclerosis, arteriosclerosis, calcinosis, or similar generalized condition not listed by the FDA as an approved use is not covered. Any such use of EDTA is considered experimental.
See §35-64 for an explanation of this conclusion.
45-21 SCALP HYPOTHERMIA DURING
CHEMOTHERAPY, TO PREVENT HAIR LOSS
Keeping the scalp cool during chemotherapy has been noted to reduce the risk
of hair loss. The cooling may be done by packing the scalp with ice-filled bags
or bandages, or by specially-designed devices filled with cold-producing
chemicals activated during chemotherapy.
While ice-filled bags or bandages or other devices used for scalp hypothermia
during chemotherapy may be covered as supplies of the kind commonly furnished
without a separate charge, no separate charge for them would be
45-22 LYMPHOCYTE IMMUNE GLOBULIN,
ANTI-THYMOCYTE GLOBULIN (EQUINE)
The lymphocyte immune globulin preparations are biologic drugs not previously
approved or licensed for use in the management of renal allograft rejection. A
number of other lymphocyte immune globulin products of equine, lapine, and
murine origin are currently under investigation for their potential usefulness
in controlling allograft rejections in human transplantation. These biologic
drugs are viewed as adjunctive to traditional immunosuppressive products such as
steroids and anti- metabolic drugs. At present, lymphocyte immune globulin
preparations are not recommended to replace conventional immunosuppressive
drugs, but to supplement them and to be used as alternatives to elevated or
accelerated dosing with conventional immunosuppressive agents.
The FDA has approved one lymphocyte immune globulin preparation for
marketing, lymphocyte immune globulin, anti-thymocyte globulin (equine). This
drug is indicated for the management of allograft rejection episodes in renal
transplantation. It is covered under Medicare when used for this purpose. Other
forms of lymphocyte globulin preparation which the FDA approves for this
indication in the future may be covered under Medicare.
45-23 DIMETHYL SULFOXIDE
DMSO is an industrial solvent produced as a chemical byproduct of paper
production from wood pulp. The Food and Drug Administration has determined that
the only purpose for which DMSO is safe and effective for humans is in the
treatment of the bladder condition, interstitial cystitis. Therefore, the use of
DMSO for all other indications is not considered to be reasonable and necessary.
Payment may be made for its use only when reasonable and necessary for a patient
in the treatment of interstitial cystitis.
45-24 ANTI-INHIBITOR COAGULANT
Anti-inhibitor coagulant complex, AICC, is a drug used to treat hemophilia in
patients with factor VIII inhibitor antibodies. AICC has been shown to be safe
and effective and has Medicare coverage when furnished to patients with
hemophilia A and inhibitor antibodies to factor VIII who have major bleeding
episodes and who fail to respond to other, less expensive therapies.
45-25 SUPPLIES USED IN THE DELIVERY
OF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) AND NEUROMUSCULAR
ELECTRICAL STIMULATION (NMES)--(Effective for services rendered (i.e., items
rented or purchased) on or after July 14, 1988.)
Transcutaneous Electrical Nerve Stimulation (TENS) and/or Neuromuscular Electrical Stimulation (NMES) can ordinarily be delivered to patients through the use of conventional electrodes, adhesive tapes and lead wires. There may be times, however, where it might be medically necessary for certain patients receiving TENS or NMES treatment to use, as an alternative to conventional electrodes, adhesive tapes and lead wires, a form-fitting conductive garment (i.e., a garment with conductive fibers which are separated from the patients' skin by layers of fabric).
A form-fitting conductive garment (and medically necessary related supplies)
may be covered under the program only when:
1. It has received permission
or approval for marketing by the Food and Drug Administration;
2. It has been prescribed by a
physician for use in delivering covered TENS or NMES treatment; and
3. One of the medical
indications outlined below is met:
A conductive garment is not covered for use with a TENS device during
the trial period specified in §35-46 unless:
4. The patient has a
documented skin problem prior to the start of the trial period; and
5. The carrier's medical
consultants are satisfied that use of such an item is medically necessary for
(See conditions for coverage of the use of TENS in the diagnosis and
treatment of chronic intractable pain in §§35-46 and 60-20
and the use of NMES in the treatment of disuse atrophy in
45-26 PLATELET-DERIVED WOUND HEALING FORMULA--NOT
A platelet-derived formula containing growth factors intended to treat
nonhealing wounds (e.g., Procuren) is provided through hospital-based outpatient
facilities as part of comprehensive wound- care programs designed to treat
patients with chronic nonhealing wounds. It is usually applied at first in the
presence of a physician, with the patient continuing applications at home. There
is a lack of sufficient published data to determine the safety and efficacy of
the platelet-derived wound healing formula (based on a technology review by the
Public Health Service). Therefore, it is not covered under Medicare because it
is not considered reasonable and necessary within the meaning of §1862(a)(1) of
45-27 BLOOD TRANSFUSIONS
Blood transfusions are used to restore blood volume after
hemorrhage, to improve the oxygen carrying capacity of blood in severe anemia,
and to combat shock in acute hemolytic anemia.
Blood Transfusion.--Homologous blood transfusion is the infusion of blood or
blood components that have been collected from the general
Blood Transfusion.--An autologous blood transfusion is the precollection and
subsequent infusion of a patient's own blood.
Directed Blood Transfusion.--A donor directed blood transfusion is the
infusion of blood or blood components that have been precollected from a
specific individual(s) other than the patient and subsequently infused into the
specific patient for whom the blood is designated. For example, patient B's
brother predeposits his blood for use by patient B during upcoming
Blood Salvage.--Perioperative blood salvage is the collection and reinfusion
of blood lost during and immediately after surgery.
Governing Transfusions.--For Medicare coverage purposes, it is important to
distinguish between a transfusion itself and preoperative blood services; e.g.,
collection, processing, storage. Medically necessary transfusion of blood,
regardless of the type, may generally be a covered service under both Part A and
Part B of Medicare. Coverage does not make a distinction between the transfusion
of homologous, autologous, or donor-directed blood. With respect to the coverage
of the services associated with the preoperative collection, processing, and
storage of autologous and donor-directed blood, the following policies
Part A and B Coverage and Payment.--Under §1862(a)(14) of the Act,
non-physician services furnished to hospital patients are covered and paid for
as hospital services. The inclusion of services provided to hospital patients by
an outside supplier as part of hospital services is referred to as "bundling."
In a situation where a hospital obtains either autologous or donor-directed
blood from an independent supplier, the supplier collects, processes, and stores
the blood and, typically, delivers it to the hospital. The hospital is
responsible for paying the supplier.
Part A payment, as specified in §1814(b) of the Act, and
Part B payment, as specified in §1833(a) of the Act, relate to reasonable cost
as defined in §1861(v) of the Act. Under this system, when a hospital obtains
autologous or donor-directed blood from an independent blood bank, Medicare
recognizes only a processing fee charged to the hospital by the independent
blood bank because the blood has been replaced, albeit in advance. The
processing fee is recorded by the hospital in the blood storing, processing, and
transfusion cost center. This cost center also includes any costs the hospital
itself incurs to process and administer the blood after it has been procured.
This includes the cost of such activities as storing, type crossmatching, and
transfusing the blood, as well as the cost of spoiled or defective blood. The
hospital may generate a charge for these costs (except for spoiled or defective
blood) and, under cost reimbursement, Medicare picks up its share of the costs
through cost apportionment. As provided in §1886 of the Act, under the
prospective payment system (PPS), the diagnosis related group (DRG) payment to
the hospital includes all covered blood and blood processing expenses, whether
or not the blood is eventually used.
In a situation where the hospital operates its own blood
collection activities, rather than using an independent blood supplier, the
costs incurred to collect autologous or donor-directed blood are recorded in the
whole blood and packed red blood cells cost center. Because the blood has been
replaced, Medicare does not recognize a charge for the blood itself. Therefore,
under cost reimbursement, these costs are shared by all patients through cost
apportionment. The costs incurred by the hospital to store, process, and
transfuse the blood, as well as the cost of spoiled or defective blood, are
recorded in the blood storing, processing, and transfusion cost center. The
hospital may generate a charge for these costs (except for the cost of spoiled
or defective blood) and, under cost reimbursement, Medicare picks up its share
of these costs through cost apportionment. Under PPS, the DRG payment is
intended to pay for all covered blood and blood services, whether or not the
blood is eventually used.
Under its provider agreement, a hospital is required to
furnish or arrange for all covered services furnished to hospital patients.
Medicare payment is made to the hospital, under PPS or cost reimbursement, for
covered inpatient and outpatient services, and it is intended to reflect payment
for all costs of furnishing those services.
Part B Coverage.--Under Part B, to be eligible for separate coverage, a
service must fit the definition of one of the services authorized by §1832 of
the Act. These services are defined in 42 CFR 410.10 and do not include a
separate category for a supplier's services associated with blood donation
services, either autologous or donor-directed. That is, the collection,
processing, and storage of blood for later transfusion into the beneficiary is
not recognized as a separate service under Part B. Therefore, there is no avenue
through which a blood supplier can receive direct payment under Part B for blood
Blood Salvage.--When the perioperative blood salvage process is used in
surgery on a hospital patient, payment made to the hospital (under PPS or
through cost reimbursement) for the procedure in which that process is used is
intended to encompass payment for all costs relating to that process.
45-28 ANTIGENS PREPARED FOR SUBLINGUAL
For antigens provided to patients on or after November
17, 1996, Medicare does not cover such antigens if they are to be administered
sublingually, i.e., by placing drops under the patient's tongue. This kind of
allergy therapy has not been proven to be safe and effective. Antigens are
covered only if they are administered by injection.