Table of Contents
35 MEDICAL PROCEDURES
35-1 COLONIC IRRIGATION--NOT
Colonic irrigation is a procedure to wash out or lavage material on the walls
of the bowel to an unlimited distance without inducing defecation. This
procedure is distinguished from all types of enemas which are primarily used to
There are no conditions for which colonic irrigation is medically indicated
and no evidence of therapeutic value. Accordingly, colonic irrigation cannot be
considered reasonable and necessary within the meaning of section 1862(a)(1) of
A. Manipulation of the Rib
Cage.--Manual manipulation of the rib cage contributes to the treatment of
respiratory conditions such as bronchitis, emphysema, and asthma as part of a
regimen which includes other elements of therapy, and is covered only under such
B. Manipulation of the Head.--Manipulation of the occipitocervical or temporomandibular regions of the head when indicated for conditions affecting those portions of the head and neck is a covered service.
35-3 HEAT TREATMENT, INCLUDING THE USE OF DIATHERMY AND ULTRA- SOUND FOR PULMONARY CONDITIONS--NOT COVERED
There is no physiological rationale or valid scientific documentation of effectiveness of diathermy or ultrasound heat treatments for asthma, bronchitis, or any other pulmonary condition and for such purpose this treatment cannot be considered reasonable and necessary within the meaning of section 1862(a)(1) of the law.
35-4 ULTRASONIC SURGERY
Reimbursement may be made for ultrasonic surgery when required in the
treatment of patients with severe and recurrent episodes of vertigo due to
This procedure utilizes a machine which produces ultrasonic waves of high intensity and frequency that selectively irradiate certain portions of the inner ear thereby destroying the tissue. The procedure is usually done under local anesthesia, and requires the services of a surgeon and another individual who is responsible for calibrating the electrical equipment, and who assists in observing certain physical changes (e.g., movement of the eyes, "nystagmus") indicative of inner ear reaction to the ultrasonic destruction. Except in rare instances the desired result is achieved with one treatment. At present, there are two different approaches being used to apply the ultrasound to the inner ear: one through the lateral semicircular canal and, more recently, a simpler approach from a technical viewpoint, through the round window.
35-5 CELLULAR THERAPY--NOT COVERED
Cellular therapy involves the practice of injecting humans with foreign
proteins like the placenta or lungs of unborn lambs. Cellular therapy is without
scientific or statistical evidence to document its therapeutic efficacy and, in
fact, is considered a potentially dangerous practice. Accordingly, cellular
therapy is not considered reasonable and necessary within the meaning of section
1862 (a) (1) of the law.
35-6 THERMOGENIC THERAPY--NOT
Thermogenic therapy which is the production of artificial fever has been in
use since 1919 in the treatment of certain types of resistant infectious
diseases, rheumatoid arthritis and Sydenham's chorea. Regardless of the medium
by which the fever is induced, this modality is not scientifically accepted for
the treatment of any specific disease. Since the advent of potent antibiotics,
the procedure has for all practical purposes been replaced as a mode of
treatment. Therefore, thermogenic therapy is not considered reasonable and
necessary for the treatment of an illness or injury as required by section
1862(a)(1) of the law. (Of course, where other covered services are
needed and it would be reasonable and necessary that they be furnished on an
inpatient hospital basis, payment would not be excluded for the inpatient stay,
notwithstanding the fact that reimbursement may not be made for thermogenic
therapy furnished during the hospital stay.)
35-7 CAROTID BODY RESECTION/CAROTID BODY
Carotid body resection is occasionally used to relieve pulmonary symptoms,
including asthma, but has been shown to lack general acceptance of the
professional medical community. In addition, controlled clinical studies
establishing the safety and effectiveness of this procedure are needed.
Therefore, all carotid body resections to relieve pulmonary symptoms must be
considered investigational and cannot be considered reasonable and necessary
within the meaning of section 1862(a)(l) of the law. No program reimbursement
may be made in such cases.
There is, however, one instance where carotid body resection has been
accepted by the medical community as effective. That instance is when evidence
of a mass in the carotid body, with or without symptoms, indicates the
need for surgery to remove the carotid body tumor.
Denervation of a carotid sinus to treat hypersensitive carotid sinus reflex
is another procedure performed in the area of the carotid body. In the case of
hypersensitive carotid sinus, light pressure on the upper part of the neck (such
as might be experienced when turning or raising one's head) results in symptoms
such as dizziness or syncope due to hypotension and slowed heart rate. Failure
of medical therapy and continued deterioration in the condition of the patient
in such cases may indicate need for surgery. Denervation of the carotid sinus is
rarely performed, but when elected as the therapy of choice with the above
indications, this procedure may be considered reasonable and necessary.
35-8 ACUPUNCTURE--NOT COVERED
Although acupuncture has been used for thousands of years in China and for
decades in parts of Europe, it is a new agent of unknown use and efficacy in the
United States. Even
in those areas of the world where it has been widely used, its mechanism is
not known. Three units of the National Institutes of Health, the National
Institute of General Medical Sciences, National Institute of Neurological
Diseases and Stroke, and Fogarty International Center have been designed to
assess and identify specific opportunities and needs for research attending the
use of acupuncture for surgical anesthesia and relief of chronic pain. Until the
pending scientific assessment of the technique has been completed and its
efficacy has been established, Medicare reimbursement for acupuncture, as an
anesthetic or as an analgesic or for other therapeutic purposes, may not be
made. Accordingly, acupuncture is not considered reasonable and necessary within
the meaning of §1862 (a) (1) of the Act.
35-9 PHACO-EMULSIFICATION PROCEDURE - CATARACT EXTRACTION
In view of recommendations of authoritative sources in the field of
ophthalmology, the subject technique is viewed as an accepted procedure for
removal of cataracts. Accordingly, program reimbursement may be made for
necessary services furnished in connection with cataract extraction utilizing
the phaco-emulsification procedure.
35-10 HYPERBARIC OXYGEN THERAPY
For purposes of coverage under Medicare, hyperbaric oxygen (HBO) therapy is a
modality in which the entire body is exposed to oxygen under increased
A. Covered Conditions.--Program
reimbursement for HBO therapy will be limited to that which is administered in a
chamber (including the one man unit) and is limited to the following
l. Acute carbon monoxide intoxication, (ICD-9-CM diagnosis 986).
2. Decompression illness, (ICD-9-CM diagnosis 993.2, 993.3).
3. Gas embolism, (ICD-9-CM diagnosis 958.0, 999.1).
4. Gas gangrene, (ICD-9-CM diagnosis 0400).
5. Acute traumatic peripheral ischemia. HBO therapy is a valuable adjunctive treatment to be used in combination with accepted standard therapeutic measures when loss of function, limb, or life is threatened. (ICD-9-CM diagnosis 902.53, 903.01, 903.1, 904.0, 904.41.)
6. Crush injuries and suturing of severed limbs. As in the previous conditions, HBO therapy would be an adjunctive treatment when loss of function, limb, or life is threatened. (ICD-9-CM diagnosis 927.00-927.03, 927.09-927.11, 927.20-927.21, 927.8-927.9, 928.00-928.01, 928.10-928.11, 928.20-928.21, 928.3, 928.8-928.9, 929.0, 929.9, 996.90-996.99.)
7. Progressive necrotizing infections (necrotizing fasciitis), (ICD-9-CM diagnosis 728.86).
8. Acute peripheral arterial insufficiency (ICD-9-CM diagnosis 444.21, 444.22, 444.81).
9. Treatment of compromised skin grafts, (ICD-9-CM diagnosis 996.52; excludes artificial skin graft).
10. Chronic refractory osteomyelitis, unresponsive to conventional medical and surgical management, (ICD-9-CM diagnosis 730.10-730.19).
11. Osteoradionecrosis as an adjunct to
conventional treatment, (ICD-9-CM diagnosis
12. Soft tissue radionecrosis as an adjunct to conventional treatment, (ICD-9-CM diagnosis 990).
13. Cyanide poisoning,(ICD-9-CM diagnosis 987.7, 989.0).
14. Actinomycosis, only as an adjunct to conventional therapy when the disease process is refractory to antibiotics and surgical treatment, (ICD-9-CM diagnosis 039.0-039.4, 039.8, 039.9).
B. Noncovered Conditions.--All
other indications not specified under §35-10 (A) are not covered under the
Medicare program. No program payment may be made for any conditions other than
those listed in §35-10 (A).
C. Reasonable Utilization
Parameters.--Make payment where HBO therapy is clinically practical. HBO
therapy should not be a replacement for other standard successful therapeutic
measures. Depending on the response of the individual patient and the severity
of the original problem, treatment may range from less than 1 week to several
months duration, the average being 2 to 4 weeks. Review and document the medical
necessity for use of hyperbaric oxygen for more than 2 months, regardless of the
condition of the patient, before further reimbursement is made.
D. Topical Application of
Oxygen.--This method of administering oxygen does not meet the definition of
HBO therapy as stated above. Also, its clinical efficacy has not been
established. Therefore, no Medicare reimbursement may be made for the topical
application of oxygen. (Cross refer: §35-31.)
Supervision Requirement--For HBO therapy to be covered under the Medicare
program, the physician must be in constant attendance during the entire
treatment. This is a professional activity that cannot be delegated in that it
requires independent medical judgement by the physician. The physician must be
present, carefully monitoring the patient during the hyperbaric oxygen therapy
session and be immediately available should a complication occur. This
requirement applies in all settings: no payment will be made under Part A or
Part B, unless the physician is in constant attendance during the HBO therapy
F. Credentials--A physician qualified in HBO therapy treatment is defined by Medicare for this purpose to be credentialed by the hospital in which HBO therapy is being performed specifically in hyperbaric medicine and the management of acute cardiopulmonary emergencies, including placement of chest tube. Credentialing includes, at a minimun, the following:
experience and privileges within the institution to manage acute cardiopulmonary
emergencies, including advanced cardiac life support, and emergency
o Completion of
a recognized hyperbaric medicine training program as established by either the
American College of Hyperbaric Medicine or the Undersea and Hyperbaric Medical
Society (UHMS) with a minimum of 60 hours of training and documented by a
certificate of completion or an equivalent program; and
medical education in hyperbaric medicine of a minimum of 16 hours every 2 years
after initial credentialing.
An additional requirement that must be met for Medicare's payment for
hyperbaric medical therapy is that cardiopulmonary resuscitation team coverage
must be immediately available during the hours of the hyperbaric chamber
A. Covered Conditions.--
o Payment may be
made only where sterilization is a necessary part of the treatment of an illness
or injury, e.g., removal of a uterus because of a tumor, removal of diseased
ovaries (bilateral oophorectomy), or bilateral orchidectomy in a case of cancer
of the prostate. Deny claims when the pathological evidence of the necessity to
perform any such procedures to treat an illness or injury is absent; and
of a mentally retarded beneficiary is covered if it is a necessary part of the
treatment of an illness or injury.
Monitor such surgeries closely and obtain the information needed to determine
whether in fact the surgery was performed as a means of treating an illness or
injury or only to achieve sterilization.
hysterectomy, tubal ligation, and vasectomy, if the stated reason for these
procedures is sterilization;
sterilization that is performed because a physician believes another pregnancy
would endanger the overall general health of the woman is not considered to be
reasonable and necessary for the diagnosis or treatment of illness or injury
within the meaning of § 1862(a)(1) of the law. The same conclusion would apply
where the sterilization is performed only as a measure to prevent the possible
development of, or effect on, a mental condition should the individual become
of a mentally retarded person where the purpose is to prevent conception, rather
than the treatment of an illness or injury.
35-12 PLASTIC SURGERY TO CORRECT "MOON
The cosmetic surgery exclusion precludes payment for any surgical procedure
directed at improving appearance. The condition giving rise to the patient's
preoperative appearance is generally not a consideration. The only exception to
the exclusion is surgery for the prompt repair of an accidental injury or for
the improvement of a malformed body member which coincidentally serves some
cosmetic purpose. Since surgery to correct a condition of "moon face" which
developed as a side effect of cortisone therapy does not meet the exception to
the exclusion, it is not covered under Medicare (§1862(a)(10) of the
Cross refer: Intermediary Manual, §3160; Carriers Manual, §2329; Hospital
35-13 PROLOTHERAPY, JOINT SCLEROTHERAPY,
AND LIGAMENTOUS INJECTIONS WITH SCLEROSING AGENTS--NOT COVERED
The medical effectiveness of the above therapies has not been verified by
scientifically controlled studies. Accordingly, reimbursement for these
modalities should be denied on the ground that they are not reasonable and
necessary as required by §1862(a)(1) of the law.
35-14 CONSULTATIONS WITH A BENEFICIARY'S
FAMILY AND ASSOCIATES
In certain types of medical conditions, including when a patient is withdrawn
and uncommunicative due to a mental disorder or comatose, the physician may
contact relatives and close associates to secure background information to
assist in diagnosis and treatment planning. When a physician contacts his
patient's relatives or associates for this purpose, expenses of such interviews
are properly chargeable as physician's services to the patient on whose behalf
the information was secured. If the beneficiary is not an inpatient of a
hospital, Part B reimbursement for such an interview is subject to the special
limitation on payments for physicians' services in connection with mental,
psychoneurotic, and personality disorders.
A physician may also have contacts with a patient's family and associates for
purposes other than securing background information. In some cases, the
physician will provide counseling to members of the household. Family counseling
services are covered only where the primary purpose of such counseling is the
treatment of the patient's condition. For example, two situations where family
counseling services would be appropriate are as follows: (1) where there is a
need to observe the patient's interaction with family members; and/or (2) where
there is a need to assess the capability of and assist the family members in
aiding in the management of the patient. Counseling principally concerned with
the effects of the patient's condition on the individual being interviewed would
not be reimbursable as part of the physician's personal services to the patient.
While to a limited degree, the counseling described in the second situation may
be used to modify the behavior of the family members, such services nevertheless
are covered because they relate primarily to the management of the patient's
problems and not to the treatment of the family member's problems.
See Medicare Intermediary Manual, §3212; Medicare Carriers Manual, §§2020 and
2470-2476.2; and Hospital Manual, §160.1.
35-15 POSTURAL DRAINAGE PROCEDURES AND
In most cases, postural drainage procedures and pulmonary exercises can be carried out safely and effectively by nursing personnel. However, in some cases patients may have acute or severe pulmonary conditions involving complex situations in which these procedures or exercises require the knowledge and skills of a physical therapist or a respiratory therapist. Therefore, if the attending physician determines as part of his/her plan of treatment that for the safe and effective administration of such services the procedures or exercises in question need to be performed by a physical therapist, the services of such a therapist constitute covered physical therapy when provided as an inpatient hospital service, extended care service, home health service, or outpatient physical therapy service.
NOTE: Physical therapy furnished in the outpatient
department of a hospital is covered under the outpatient physical therapy
If the attending physician determines that the services should be performed by a respiratory therapist, the services of such a therapist constitute covered respiratory therapy when provided as an inpatient hospital service, outpatient hospital service, or extended care service, assuming that such services are furnished to the skilled nursing facility by a hospital with which the facility has a transfer agreement. Since the services of a respiratory therapist are not covered under the home health benefit, payment may not be made under the home health benefit for visits by a respiratory therapist to a patient's home to provide such services. Postural drainage procedures and pulmonary exercises are also covered when furnished by a physical therapist or a respiratory therapist as incident to a physician's professional service.
See Medicare Intermediary Manual, §§3112, 3116, and 3133.90 and Medicare
Carriers Manual, §2050.2.
Vitrectomy may be considered reasonable and necessary for the following conditions: vitreous loss incident to cataract surgery, vitreous opacities due to vitreous hemorrhage or other causes, retinal detachments secondary to vitreous strands, proliferative retinopathy, and vitreous retraction. See chapter 15 of the Medicare Carriers Manual for how to determine payment for physician vitrectomy services and §5243 of the Medicare Carriers Manual for how to determine payment for ASC facility vitrectomy services. Also, see §4630 of the Medicare Carriers Manual to identify when, for Medicare payment purposes, certain vitrectomy codes are included in other codes or when codes for other services include vitrectomy codes. The CPT codes for vitrectomy services are 67005, 67010, 67036, 67038, 67039, and 67040.
35-17 INDUCED LESIONS OF NERVE
Surgically induced lesions of nerve tracts, which involve destruction of nerve tissue, are primarily indicated for controlling the chronic or acute pain arising from conditions such as terminal cancer or lumbar degenerative arthritis. Induced lesions of nerve tracts may be produced by surgical cutting of the nerve (rhizolysis), chemical destruction of the nerve, or by creation of a radio-frequency lesion (electrocautery). Accordingly, program payment may be made for these denervation procedures when used in selected cases (concurred in by contractor's medical staff) to treat chronic pain.
Note that these procedures differ from those employing implanted electrodes
and associated equipment to control pain in that the nerve fibers are ablated
rather than stimulated and no electronic equipment is required by the patient
after the operation.
35-19 INTRAVENOUS HISTAMINE
The only accepted and scientifically valid medical use of histamine is diagnostic, including tests to assess:
However, there is no scientifically valid clinical evidence that histamine
therapy is effective for any condition regardless of the method of
administration, nor is it accepted or widely used by the medical profession.
Therefore, histamine therapy cannot be considered reasonable and
necessary, and program payment for such therapy is not made.
35-20 TREATMENT OF MOTOR FUNCTION
DISORDERS WITH ELECTRIC NERVE STIMULATION-NOT COVERED
While electric nerve stimulation has been employed to control chronic intractable pain for some time, its use in the treatment of motor function disorders, such as multiple sclerosis, is a recent innovation, and the medical effectiveness of such therapy has not been verified by scientifically controlled studies. Therefore, where electric nerve stimulation is employed to treat motor function disorders, no reimbursement may be made for the stimulator or for the services related to its implantation since this treatment cannot be considered reasonable and necessary.
See §§35-27 and 65-8.
NOTE: Medicare coverage of deep brain
stimulation by implantation of a stimulator device is not prohibited. Therefore,
coverage of deep brain stimulation provided by an implanted deep brain
stimulator is at the carrier's discretion.
35-21 INPATIENT HOSPITAL PAIN REHABILITATION PROGRAMS
Pain rehabilitation programs are a relatively new and innovative approach to the treatment of intractable pain. The goal of such programs is to give a patient the tools to manage and control his/her pain and thereby improve his/her ability to function independently.
A hospital level pain rehabilitation program is one that employs a
coordinated multidisciplinary team to deliver, in a controlled environment, a
concentrated program which is designed to modify pain behavior through the
treatment of the physiological, psychological, and social aspects of pain. Such
programs generally include diagnostic testing, skilled nursing, psychotherapy,
structured progressive withdrawal from pain medications, physical therapy and
occupational therapy to restore physical fitness (mobility and endurance) to
maximal level within the constraints of a patient's physical disability, and
the use of mechanical devices and/or activities to relieve pain or modify a
patient's reaction to it (e.g., nerve stimulator, hydrotherapy, massage, ice,
systemic muscle relaxation training, and diversional activities). The nurse's
responsibility in such pain rehabilitation programs is to observe and assess, on
a continuing basis, a patient's condition and response to the program as
reflected by his actions while in the nursing unit, and to assure that the
atmosphere within the unit is not supportive of pain behavior. The day-to- day
activities involved in carrying out the program are under the general
supervision and, as needed, direct supervision of a physician.
Since pain rehabilitation programs of a lesser scope than that described
above would raise a question as to whether the program could be provided in a
less intensive setting than on an inpatient hospital basis, carefully evaluate
such programs to determine whether the program does, in fact, necessitate a
hospital level of care. Some pain rehabilitation programs may utilize services
and devices which are excluded from coverage, e.g., acupuncture (see §35-8),
biofeedback (see §35-27), dorsal column stimulator (see §65-8), and family
counseling services (see §35-l4). In determining whether the scope of a pain
program does necessitate inpatient hospital care, evaluate only those services
and devices which are covered. Although diagnostic tests may be an appropriate
part of pain rehabilitation programs, such tests would be covered in an
individual case only where they can be reasonably related to a patient's
illness, complaint, symptom, or injury and where they do not represent an
unnecessary duplication of tests previously performed.
An inpatient program of 4 weeks' duration is generally required to modify
pain behavior. After this period it would be expected that any additional
rehabilitation services which might be required could be effectively provided on
an outpatient basis under an outpatient pain rehabilitation program (see
§35-21.1sf2) or other outpatient program. The first 7-l0 days of such an
inpatient program constitute, in effect, an evaluation period. If a patient is
unable to adjust to the program within this period, it is generally concluded
that it is unlikely that the program will be effective and the patient is
discharged from the program. On occasions a program longer than 4 weeks may be
required in a particular case. In such a case there should be documentation to
substantiate that inpatient care beyond a 4-week period was reasonable and
necessary. Similarly, where it appears that a patient participating in a program
is being granted frequent outside passes, a question would exist as to whether
an inpatient program is reasonable and necessary for the treatment of the
An inpatient hospital stay for the purpose of participating in a pain
rehabilitation program would be covered as reasonable and necessary to the
treatment of a patient's condition where the pain is attributable to a physical
cause, the usual methods of treatment have not been successful in alleviating
it, and a significant loss of ability to function independently has resulted
from the pain. Chronic pain patients often have psychological problems which
accompany or stem from the physical pain and it is appropriate to include
psychological treatment in the multidisciplinary approach. However, patients
whose pain symptoms result from a mental condition, rather than from any
physical cause, generally cannot be succesfully treated in a pain rehabilitation
35-21.1 OUTPATIENT HOSPITAL PAIN
Some hospitals also provide pain rehabilitation programs for outpatients. In
such programs, services frequently are provided in group settings even though
they are being furnished pursuant to each patient's individualized plan of
Coverage of services furnished under outpatient hospital pain rehabilitation programs, including services furnished in group settings under individualized plans of treatment, is available if the patient's pain is attributable to a physical cause, the usual methods of treatment have not been successful in alleviating it, and a significant loss of ability by the patient to function independently has resulted from the pain. If a patient meets these conditions and the program provides services of the types discussed in §35-21 the services provided under the program may be covered. Noncovered services (e.g., vocational counseling, meals for outpatients, or acupuncture) continue to be excluded from coverage, and intermediaries would not be precluded from finding, in the case of particular patients, that the pain rehabilitation program is not reasonable and necessary under §1862(a)(1) of the law for the treatment of their conditions.
35-22 INPATIENT HOSPITAL STAYS FOR THE
TREATMENT OF ALCOHOLISM
A. Inpatient Hospital Stay for Alcohol
Detoxification.--Many hospitals provide detoxification services during the
more acute stages of alcoholism or alcohol withdrawal. When the high probability
or occurrence of medical complications (e.g., delirium, confusion, trauma, or
unconsciousness) during detoxification for acute alcoholism or alcohol
withdrawal necessitates the constant availability of physicians and/or complex
medical equipment found only in the hospital setting, inpatient hospital care
during this period is considered reasonable and necessary and is therefore
covered under the program. Generally, detoxification can be accomplished within
2-3 days with an occasional need for up to 5 days where the patient's condition
dictates. This limit (5 days) may be extended in an individual case where there
is a need for a longer period for detoxification for a particular patient. In
such cases, however, there should be documentation by a physician which
substantiates that a longer period of detoxification was reasonable and
necessary. When the detoxification needs of an individual no longer require an
inpatient hospital setting, coverage should be denied on the basis that
inpatient hospital care is not reasonable and necessary as required by section
l862(a)(l) of the law. Following detoxification a patient may be transferred to
an inpatient rehabilitation unit or discharged to a residential treatment
program or outpatient treatment setting.
B. Inpatient Hospital Stay for Alcohol
Rehabilitation.--Hospitals may also provide structured inpatient alcohol
rehabilitation programs to the chronic alcoholic. These programs are composed
primarily of coordinated educational and psychotherapeutic services provided on
a group basis. Depending on the subject matter, a series of lectures,
discussions, films, and group therapy sessions are led by either physicians,
psychologists, or alcoholism counselors from the hospital or various outside
organizations. In addition, individual psychotherapy and family counseling (see
§ 35-14) may be provided in selected cases. These programs are conducted under
the supervision and direction of a physician. Patients may directly enter an
inpatient hospital rehabilitation program after having undergone detoxification
in the same hospital or in another hospital or may enter an inpatient hospital
rehabilitation program without prior hospitalization for
Alcohol rehabilitation can be provided in a variety of settings other than
the hospital setting. In order for an inpatient hospital stay for alcohol
rehabilitation to be covered under Medicare it must be medically necessary for
the care to be provided in the inpatient hospital setting rather than in a less
costly facility or on an outpatient basis. Inpatient hospital care for receipt
of an alcohol rehabilitation program would generally be medically necessary
where either (l) there is documentation by the physician that recent alcohol
rehabilitation services in a less intensive setting or on an outpatient basis
have proven unsuccessful and, as a consequence, the patient requires the
supervision and intensity of services which can only be found in the controlled
environment of the hospital, or (2) only the hospital environment can
assure the medical management or control of the patient's concomitant conditions
during the course of alcohol rehabilitation. (However, a patient's concomitant
condition may make the use of certain alcohol treatment modalities medically
inappropriate.) In addition, the "active treatment" criteria (see HCFA-Pub.
13-3, § 3l02.l or HCFA-Pub. 10, § 2l2.1) should be applied to psychiatric care
in the general hospital as well as to psychiatric care in a psychiatric
hospital. Since alcoholism is classifiable as a psychiatric condition the
"active treatment" criteria must also be met in order for alcohol rehabilitation
services to be covered under Medicare. (Thus, it is the combined need for
"active treatment" and for covered care which can only be provided in the
inpatient hospital setting, rather than the fact that rehabilitation
immediately follows a period of detoxification, which provides the basis for
coverage of inpatient hospital alcohol rehabilitation programs.)
Generally l6-l9 days of rehabilitation services are sufficient to bring a
patient to a point where care could be continued in other than an inpatient
hospital setting. An inpatient hospital stay for alcohol rehabilitation may be
extended beyond this limit in an individual case where a longer period of
alcohol rehabilitation is medically necessary. In such cases, however, there
should be documentation by a physician which substantiates the need for such
care. Where the rehabilitation needs of an individual no longer require an
inpatient hospital setting, coverage should be denied on the basis that
inpatient hospital care is not reasonable and necessary as required by section
l862 (a)(l) of the law.
Subsequent admissions to the inpatient hospital setting for alcohol
rehabilitation followup, reinforcement, or "recap" treatments are considered to
be readmissions (rather than an extension of the original stay) and must meet
the requirements of this section for coverage under Medicare. Prior admissions
to the inpatient hospital setting--either in the same hospital or in a different
hospital--may be an indication that the "active treatment" requirements are not
met (i.e., there is no reasonable expectation of improvement) and the stay
should not be covered. Accordingly, there should be documentation to establish
that "readmission" to the hospital setting for alcohol rehabilitation services
can reasonably be expected to result in improvement of the patient's condition.
For example, the documentation should indicate what changes in the patient's
medical condition, social or emotional status, or treatment plan make
improvement likely, or why the patient's initial hospital treatment was not
C. Combined Alcohol
Detoxification/Rehabilitation Programs.--Fiscal intermediaries should apply
the guidelines in A. and B. above to both phases of a combined inpatient
hospital alcohol detoxification/rehabilitation program. Not all patients who
require the inpatient hospital setting for detoxification also need the
inpatient hospital setting for rehabilitation. (See § 35-22.l for coverage of
outpatient hospital alcohol rehabilitation services.) Where the inpatient
hospital setting is medically necessary for both alcohol detoxification and
rehabilitation, generally a 3-week period is reasonable and necessary to bring
the patient to the point where care can be continued in other than an inpatient
Decisions regarding reasonableness and necessity of treatment, the need for
an inpatient hospital level of care, and length of treatment should be made by
intermediaries based on accepted medical practice with the advice of their
medical consultant. (In hospitals under PSRO review, PSRO determinations of
medical necessity of services and appropriateness of the level of care at which
services are provided are binding on the title XVIII fiscal intermediaries for
purposes of adjudicating claims for payment.)
35-22.l OUTPATIENT HOSPITAL SERVICES FOR
TREATMENT OF ALCOHOLISM
Some hospitals also provide services on an outpatient basis, either
individually or as part of a day hospitalization program, for treatment of
alcoholism. These services may include, for example, drug therapy,
psychotherapy, and patient education and may be furnished by physicians,
psychologists, nurses, and alcoholism counselors to individuals who have been
discharged from an inpatient hospital stay for treatment of alcoholism and
require continued treatment or to individuals from the community who require
treatment but do not require the inpatient hospital setting.
Coverage is available for both diagnostic and therapeutic services furnished
for the treatment of alcoholism by the hospital to outpatients subject to the
same rules applicable to outpatient hospital services in general (see HCFA-Pub.
13-3, §§3ll2 ff.; HCFA-Pub. 10, §§230 ff.). While there is no coverage for day
hospitalization programs, per se, individual services which meet the
requirements in HCFA-Pub. 13-3, §§3ll2 ff. or HCFA-Pub. 10, §§230 ff. may be
covered. (Meals, transportation and recreational and social activities do not
fall within the scope of covered outpatient hospital services under
All services must be reasonable and necessary for diagnosis or treatment of
the patient's condition (see HCFA-Pub. 13-3, §3l5l; HCFA-Pub. 10, §260.1). Thus,
educational services and family counseling would only be covered where they are
directly related to treatment of the patient's condition. (See also §35-14.) The
frequency of treatment and period of time over which it occurs must also be
reasonable and necessary.
35-22.2 TREATMENT OF DRUG ABUSE (CHEMICAL
We recognize that there are similarities between the approach to treatment of
drug abuse and alcohol detoxification and rehabilitation. However, the intensity
and duration of treatment for drug abuse may vary (depending on the particular
substance(s) of abuse, duration of use, and the patient's medical and emotional
condition) from the duration of treatment or intensity needed to treat
alcoholism. Accordingly, when it is medically necessary for a patient to receive
detoxification and/or rehabilitation for drug substance abuse as a hospital
inpatient, coverage for care in that setting is available. Coverage is also
available for treatment services that are provided in the outpatient department
of a hospital to patients who, for example, have been discharged from an
inpatient stay for the treatment of drug substance abuse or who require
treatment but do not require the availability and intensity of services found
only in the inpatient hospital setting. The coverage available for these
services is subject to the same rules generally applicable to the
coverage of outpatient hospital services. (See HCFA-Pub. 13-3, §§ 3ll2 ff.;
HCFA-Pub. 10, §§ 230 ff.). The services must also be reasonable and necessary
for treatment of the individual's condition. (See HCFA-Pub. 13-3, § 3l5l;
HIM-10, § 260.1.) Decisions regarding reasonableness and necessity of treatment,
the need for an inpatient hospital level of care, and length of treatment should
be made by intermediaries based on accepted medical practice with the advice of
their medical consultant. (In hospitals under PSRO review, PSRO determinations
of medical necessity of services and appropriateness of the level of care at
which services are provided are binding on the title XVIII fiscal intermediaries
for purposes of adjudicating claims for payment.)
35-22.3 TREATMENT OF ALCOHOLISM AND DRUG
ABUSE IN A FREESTANDING CLINIC
Coverage is available for alcoholism or drug abuse treatment services (such as drug therapy, psychotherapy, and patient education) that are provided incident to a physician's professional service in a freestanding clinic to patients who, for example, have been discharged from an inpatient hospital stay for the treatment of alcoholism or drug abuse or to individuals who are not in the acute stages of alcoholism or drug abuse but require treatment. The coverage available for these services is subject to the same rules generally applicable to the coverage of clinic services. (See HCFA-Pub. 14- 3, §§ 2020 ff., and §§ 2050 ff.) Of course, the services also must be reasonable and necessary for the diagnosis or treatment of the individual's alcoholism or drug abuse. The Part B psychiatric limitation (see HCFA-Pub. 14-3, § 2470) would apply to alcoholism or drug abuse treatment services furnished by physicians to individuals who are not hospital inpatients.
35-23 CHEMICAL AVERSION THERAPY FOR
TREATMENT OF ALCOHOLISM
Chemical aversion therapy is a behavior modification technique that is used
in the treatment of alcoholism. Chemical aversion therapy facilitates alcohol
abstinence through the development of conditioned aversions to the taste, smell,
and sight of alcohol beverages. This is accomplished by repeatedly pairing
alcohol with unpleasant symptoms (e.g., nausea) which have been induced by one
of several chemical agents. While a number of drugs have been employed in
chemical aversion therapy, the three most commonly used are emetine,
apomorphine, and lithium. None of the drugs being used, however, have yet been
approved by the Food and Drug Administration specifically for use in chemical
aversion therapy for alcoholism. Accordingly, when these drugs are being
employed in conjunction with this therapy, patients undergoing this treatment
need to be kept under medical observation.
Available evidence indicates that chemical aversion therapy may be an
effective component of certain alcoholism treatment programs, particularly as
part of multimodality treatment programs which include other behavioral
techniques and therapies, such as psychotherapy. Based on this evidence, HCFA's
medical consultants have recommended that chemical aversion therapy be covered under Medicare. However, since chemical aversion therapy
is a demanding therapy which may not be appropriate for all Medicare
beneficiaries needing treatment for alcoholism, a physician should certify to
appropriateness of chemical aversion therapy in the individual case.Therefore, if chemical aversion therapy for treatment of alcoholism is determined to be reasonable and necessary for an individual patient, it is covered under Medicare.
When it is medically necessary for a patient to receive chemical aversion
therapy as a hospital inpatient, coverage for care in that setting is available.
(See §35-22 regarding coverage of multimodality treatment programs.) Followup treatments for chemical aversion therapy can
generally be provided on an outpatient basis. Thus, where a patient is admitted
as an inpatient for receipt of chemical aversion therapy, there must be
documentation by the physician of the need in the individual case for the
inpatient hospital admission.
Decisions regarding reasonableness and necessity of treatment and the need
for an inpatient hospital level of care should be made by intermediaries based
on accepted medical practice with the advice of their medical consultant. (In
hospitals under PSRO review, PSRO determinations of medical necessity of
services and appropriateness of the level of care at which services are provided
are binding on the title XVIII fiscal intermediaries for purposes of
adjudicating claims for payment.)
35-23.l ELECTRICAL AVERSION THERAPY FOR
TREATMENT OF ALCOHOLISM (ELECTROVERSION THERAPY, ELECTRO-SHOCK THERAPY, NOXIOUS
Electrical aversion therapy is a behavior modification technique to foster abstinence from ingestion of alcoholic beverages by developing in a patient conditioned aversions to their taste, smell and sight through electric stimulation. Electrical aversion therapy has not been shown to be safe and effective and therefore is excluded from coverage. (See also §§ 35-22, 35-23, and 35-27).
35-24 DIAGNOSIS AND TREATMENT OF
Program payment may be made for diagnosis and treatment of sexual impotence.
Impotence is a failure of a body part for which the diagnosis, and frequently
35-25 CARDIAC REHABILITATION
A. General.--Exercise programs for
cardiac patients, commonly referred to as cardiac rehabilitation programs, are
increasingly being conducted in specialized, free-standing, cardiac
rehabilitation clinics as well as in outpatient hospital departments. Exercise
programs include specific types of exercise, individually prescribed for each
Medicare coverage of cardiac rehabilitation programs are considered
reasonable and necessary only for patients with a clear medical need, who are
referred by their attending physician and (1) have a documented diagnosis of
acute myocardial infarction within the preceding 12 months; or (2) have had
coronary bypass surgery; and/or (3) have stable angina pectoris.
Cardiac rehabilitation programs may be provided either by the outpatient
department of a hospital or in a physician-directed clinic. Coverage for either
program is subject to the following conditions:
o The facility meets the definition of a hospital outpatient department or a physician- directed clinic, i.e., a physician is on the premises available to perform medical duties at all times the facility is open, and each patient is under the care of a hospital or clinic physician;
o The facility
has available for immediate use all the necessary cardio-pulmonary emergency
diagnostic and therapeutic life saving equipment accepted by the medical
community as medically necessary, e.g., oxygen, cardiopulmonary resuscitation
equipment, or defibrillator;
o The program is
conducted in an area set aside for the exclusive use of the program while it is
o The program is
staffed by personnel necessary to conduct the program safely and effectively,
who are trained in both basic and advanced life support techniques and in
exercise therapy for coronary disease. Services of nonphysician personnel must
be furnished under the direct supervision of a physician. Direct supervision
means that a physician must be in the exercise program area
and immediately available and accessible for an emergency at all times the
exercise program is conducted. It does not require that a physician be
physically present in the exercise room itself, provided the contractor does not
determine that the physician is too remote from the patients' exercise area to
be considered immediately available and accessible. The examples below are for
illustration purposes only. They are not meant to limit the discretion of the
contractor to make determinations in this regard.
- The case in which a contractor determines that
the presence of a physician in an office across the hall from the exercise room
who is available at all times for an emergency meets the requirement that the
physician is immediately available and accessible;
- The case in which a contractor determines that the presence of a physician in a building other than that containing the exercise room does not meet the requirement that the physician is immediately available and accessible; and
o The nonphysician personnel are employees of either the physician, hospital, or clinic conducting the program and their services are "incident-to a physician's professional services."
Contractors need not undertake elaborate or costly monitoring activities to
determine whether these requirements are met, but need only satisfy themselves
to the extent that they ordinarily do in connection with, for example, the
requirements for coverage of services in physician-directed clinics. (See
Carriers Manual, §2050.4; Intermediary Manual, §3112.4A; Hospital Manual,
In addition to the conditions listed above, coverage for cardiac
rehabilitation programs furnished by hospitals to outpatients are also subject
to the rules described in the Intermediary Manual, §3ll2.4 and the Hospital
Manual, §230.4. Reasonable charge reimbursement for these services which are
performed in "freestanding" clinics are subject to the limitations set forth in
the Carriers Manual, §5241.
B. Diagnostic Testing - Stress
Testing.--A prospective candidate for a cardiac rehabilitation program must
be evaluated for his suitability to participate. A valuable diagnostic test for
this purpose is the stress test. The program need not necessarily include a
stress test, but may accept one performed by the patient's attending physician.
Stress testing performed in the outpatient department of a hospital or in a
physician-directed clinic may be covered when reasonable and necessary for one
or more of the following:
o Evaluation of chest pain, especially atypical chest pain;
o Development of exercise prescriptions for patients with known cardiac disease; and/or
o Pre and postoperative evaluation of patients undergoing coronary artery by-pass procedures.
Refer to subsection E, Utilization Screens, for the acceptable frequency of
stress testing performed during an individual's exercise program.
ECG Rhythm Strips. ECG rhythm strips (and other ECG monitoring)
constitute an important and necessary procedure which should be done
periodically while a cardiac patient is engaged in a physician-controlled
exercise program. See subsection E, Utilization Screens, for allowable
C. Other Diagnostic and Therapeutic
Services.--A freestanding or hospital based cardiac rehabilitation clinic
may also provide diagnostic and therapeutic services other than stress testing
and ECG monitoring. Any such other services must meet the usual coverage
requirements for the specific service, e.g., the incident-to, and reasonable and
1. Psychotherapy and Psychological Testing.--It would
not normally be considered reasonable and necessary to provide psychotherapy to
all cardiac rehabilitation patients, or even to test all such patients to
determine whether they may have a mental, psychoneurotic, or personality
disorder. However, where a patient has a diagnosed mental, psychoneurotic, or
personality disorder, psychotherapy furnished by a psychiatrist--or by a
psychologist rendering such services incident to a physician's professional
service--may be covered. Similarly, diagnostic testing of a cardiac
rehabilitation patient for a mental problem may be covered where the patient
shows appropriate symptoms, e.g., excessive anxiety or fear associated with the
and Occupational Therapy.--Physical therapy and occupational therapy would
not be covered when furnished in connection with cardiac rehabilitation exercise
program services covered under this section unless there also is a diagnosed
noncardiac condition requiring such therapy, e.g., where a patient who is just
recuperating from an acute phase of heart disease may have had a stroke which
would require physical and/or occupational therapy. (While the cardiac
rehabilitation exercise program may by some be considered a form of physical
therapy, it is a specialized program conducted and/or supervised by specially
trained personnel whose services are performed under the direct supervision of a
physician.) Restrictions on coverage of physical therapy and occupational
therapy under this section do not affect rules regarding coverage or noncoverage
of such services when furnished in a hospital inpatient or outpatient
(See Intermediary Manual, §3101.9 and Hospital Manual, §210.9.)
Education Services.--Many cardiac rehabilitation programs provide health
education in the form of lectures or counseling in which patients and/or family
members are given information, e.g., on diet, nutrition, and sexual activity to
assist them in adjusting their living habits because of the cardiac condition.
However, the same kind of information would have been furnished to a patient
and/or family members by the attending physician following the patient's acute
cardiac episode. Therefore, formal lectures and counseling on these subjects are
not considered reasonable and necessary as a separately identifiable service
when provided as a part of a cardiac rehabilitation exercise program. In
addition, where a free-standing cardiac rehabilitation clinic provides board and
room for the patient (and in some cases family members), these services are not
covered under Medicare.
D. Duration of the
Program.--Services provided in connection with a cardiac rehabilitation
exercise program may be considered reasonable and necessary for up to 36
sessions, usually 3 sessions a week in a single 12 week period. Coverage for
continued participation in cardiac exercise programs beyond 12 weeks would be
allowed only on a case-by-case basis with exit criteria taken into
Although firm exit criteria for terminating the therapeutic outpatient
exercise treatment and rehabilitation program have not been established, the
following guidelines have been identified as acceptable:
o The patient
has achieved a stable level of exercise tolerance without ischemia or
o Symptoms of angina or dyspnea are stable at the patient's maximum exercise level;
o Patient's resting blood pressure and heart rate are within normal limits; or
o The stress
test is not positive during exercise. (A positive test in this
context implies an ECG with a junctional depression of 2mm or more associated
with slowly rising, horizontal, or down sloping ST segment.)
Accordingly, claims for coverage of cardiac rehabilitation exercise programs
beyond 12 weeks are reviewed by the contractors' medical consultants. When
claims are accompanied by acceptable documentation that the patient has not
reached an exit level, coverage may be extended, but should not exceed a maximum
of 24 weeks.
E. Utilization Screens.--Patients
who participate in cardiac rehabilitation programs will require certain services
more frequently than other patients being treated on an outpatient basis.
Therefore, in order to provide coverage in a uniform manner, the following
utilization screens should be implemented in addition to existing screens for
any cardiac rehabilitation services not listed:
1. Group 1
o Continuous ECG telemetric monitoring during
o ECG rhythm strip with interpretation and physician's revision of exercise prescription; and
o Limited examination for physician followup to adjust medication or other treatment changes.
A visit including one or more of this range of routine services is considered
as one routine cardiac rehabilitation visit. In order for the visit to be
reimbursable, at least one of the Group 1 services must be performed. The same
rate of reimbursement would be allowed for each visit, but not all the services
need be performed at each visit.
Allow a maximum of three visits per week.
2. Group 2
o New patient comprehensive evaluation, including history,
physical, and preparation of initial exercise prescription.
Allow one at the beginning of the program if not already performed by the
patient's attending physician, or if that performed by the patient's attending
physician is not acceptable to the program's director.
o ECG stress test (treadmill or bicycle ergometer) with
physician monitoring and report.
Allow one at the beginning of the program and one after 3 months (usually the completion of the program).
o Other physician services, as needed.
35-26 TREATMENT OF OBESITY
Obesity itself cannot be considered an illness. The immediate cause is a
caloric intake which is persistently higher than caloric output. Program payment
may not be made for treatment of obesity alone since this treatment is not
reasonable and necessary for the diagnosis or treatment of an illness or injury.
However, although obesity is not in itself an illness, it may be caused by
illnesses such as hypothyroidism, Cushing's disease, and hypothalamic lesions.
In addition, obesity can aggravate a number of cardiac and respiratory diseases
as well as diabetes and hypertension. Therefore, services in connection with the
treatment of obesity are covered services when such services are an integral and
necessary part of a course of treatment for one of these illnesses.
Cross refer: CIM 35-33 and 35-40
35-26.1 SUPPLEMENTED FASTING
Supplemented fasting is a type of very low calorie weight reduction regimen
used to achieve rapid weight loss. The reduced calorie intake is supplemented by
a mixture of protein, carbohydrates, vitamins and minerals. Serious questions
exist about the safety of prolonged adherence for 2 months or more to a very low
calorie weight reduction regimen as a general treatment for obesity, because of
instances of cardiopathology and sudden death, as well as possible loss of body
protein. Therefore, supplemented fasting is not covered as a general treatment
In cases where weight loss is necessary before surgery in order to ameliorate
the complications posed by obesity when it coexists with pathological conditions
such as cardiac and respiratory diseases, diabetes or hypertension (and other
more conservative techniques to achieve this end are not regarded as
appropriate), supplemented fasting with adequate monitoring of the patient are
covered under Medicare on a case-by-case basis, as determined by your medical
consultant. The risks associated with the achievement of rapid weight loss must
be carefully balanced against the risk posed by the condition requiring surgical
35-27 BIOFEEDBACK THERAPY
Biofeedback therapy provides visual, auditory or other evidence of the status
of certain body functions so that a person can exert voluntary control over the
functions, and thereby alleviate an abnormal bodily condition. Biofeedback
therapy often uses electrical devices to transform bodily signals indicative of
such functions as heart rate, blood pressure, skin temperature, salivation,
peripheral vasomotor activity, and gross muscle tone into a tone or light, the
loudness or brightness of which shows the extent of activity in the function
Biofeedback therapy differs from electromyography, which is a diagnostic
procedure used to record and study the electrical properties of skeletal muscle.
An electromyography device may be used to provide feedback with certain types of
Biofeedback therapy is covered under Medicare only when it is reasonable and
necessary for the individual patient for muscle re-education of specific muscle
groups or for treating pathological muscle abnormalities of spasticity,
incapacitating muscle spasm, or weakness, and more conventional treatments
(heat, cold, massage, exercise, support) have not been successful. This therapy
is not covered for treatment of ordinary muscle tension states or for
psychosomatic conditions. (See HCFA-Pub. 14-3, §§2200ff, 2215, and 4161;
HCFA-Pub. 13-3, §§3133.3, 3148, and 3149; HCFA- Pub. 10, §§242 and 242.5 for
special physical therapy requirements. See also §35-20 and 65-8.)
35-29 OXYGEN TREATMENT OF INNER
EAR/CARBON THERAPY (Effective for services performed on and after August 1,
Oxygen (95 percent) and carbon dioxide (5 percent) inhalation therapy for inner ear disease, such as endolymphatic hydrops and fluctuant hearing loss, is not reasonable and necessary. The therapeutic benefit deriving from this procedure is highly questionable.
35-30 BLOOD PLATELET
Effective for services performed on or after August 1, 1978, blood platelet transplants are safe and effective for the correction of thrombocytopenia and other blood defects. It is covered under Medicare when treatment is reasonable and necessary for the individual patient.
35-30.1 STEM CELL
Stem cell transplantation is a process in which stem
cells are harvested from either a patient's or donor's bone marrow or peripheral
blood for intravenous infusion. The transplant can be used to effect
hematopoietic reconstitution following severely myelotoxic doses of chemotherapy
(HDCT) and/or radiotherapy used to treat various malignancies. Allogeneic stem
cell transplant may also be used to restore function in recipients having an
inherited or acquired deficiency or defect.
Stem Cell Transplantation.--Allogeneic stem cell transplantation (ICD-9-CM
codes 41.02 and 41.03) is a procedure in which a portion of a healthy donor's
stem cell or bone marrow is obtained and prepared for intravenous infusion.
Conditions.--The following uses of allogeneic bone marrow transplantation
are covered under
o Effective for services performed on or after August 1, 1978, for the treatment of leukemia, leukemia in remission (ICD-9-CM codes 204.00 through 208.91), or aplastic anemia (ICD-9-CM codes 284.0 through 284.9) when it is reasonable and necessary; and
o Effective for services performed on or after June 3,
1985, for the treatment of severe combined immunodeficiency disease
(SCID) (ICD-9-CM code 279.2), and for the treatment of Wiskott - Aldrich
syndrome (ICD-9-CM 279.12).
Noncovered Conditions.--Effective May 24, 1996,
allogeneic stem cell transplantation is not covered as treatment for multiple
myeloma (ICD-9-CM codes 203.0 and 238.6).
Stem Cell Transplantation (Effective for Services Performed on or After
04/28/89).--Autologous stem cell transplantation (ICD-9-CM procedure code
41.01 or 41.04) is a technique for restoring stem cells using the patient's own
previously stored cells.
1. Covered Conditions.--Autologous stem cell
transplantation (ICD-9-CM code 41.01, CPT-4 code 38241) is considered reasonable
and necessary under §l862(a)(1)(A) of the Act for the following
conditions and is covered under Medicare for patients with:
o Acute leukemia in remission (ICD-9-CM codes 204.01,
lymphoid; 205.01, myeloid; 206.01, monocytic; 207.01, acute erythremia and
erythroleukemia; and 208.01 unspecified cell type) who have a high probability
of relapse and who have no human leucocyte antigens (HLA)- matched;
o Resistant non-Hodgkin's lymphomas (ICD-9-CM codes
200.00-200.08, 200.10- 200.18, 200.20-200.28, 200.80-200.88, 202.00-202.08,
202.80-202.88, and 202.90-202.98) or those presenting with poor prognostic
features following an initial response;
o Recurrent or refractory neuroblastoma (see ICD-9-CM Neoplasm
by site, malignant); or
o Advanced Hodgkin's disease (ICD-9-CM codes 201.00-201.98)
who have failed conventional therapy and have no HLA-matched donor.
2. Noncovered Conditions.--Insufficient data exist to
establish definite conclusions regarding the efficacy of autologous stem cell
transplantation for the following conditions:
o Acute leukemia not in remission (ICD-9-CM codes 204.00,
205.00, 206.00, 207.00 and 208.00);
o Chronic granulocytic leukemia (ICD-9-CM codes 205.10 and
o Solid tumors (other than neuroblastoma) (ICD-9-CM codes
o Effective May 24, 1996, multiple myeloma
(ICD-9-CM code 203.0 and 238.6).
In these cases, autologous stem cell transplantation is
not considered reasonable and necessary within the meaning of §l862(a)(1)(A) of
the Act and is not covered under Medicare.
35-31 TREATMENT OF DECUBITUS ULCERS
An accepted procedure for healing decubitus ulcers is to remove dead tissue
from the lesions and to keep them clean to promote the growth of new tissue.
This may be accomplished by hydrotherapy (whirlpool) treatments. Hydrotherapy
(whirlpool) treatment for decubitus ulcers is a covered service under Medicare
for patients when treatment is reasonable and necessary. Some other methods of
treating decubitus ulcers, the safety and effectiveness of which have not been
established, are not covered under the Medicare program. Some examples of these
types of treatments are: ultraviolet light, low intensity direct current,
topical application of oxygen, and topical dressings with Balsam of Peru in
35-32 VERTEBRAL ARTERY SURGERY
Obstructions which block the flow of blood through the vertebral artery can
cause vertigo, visual or speech defects, ataxia, mental confusion, or stroke.
These symptoms in patients result from reduction in blood flow to the brain and
range from symptoms of transient basilar ischemia to mental deterioration or
Five types of surgical procedures are performed to relieve obstructions to
vertebral artery blood flow. They are:
These procedures can be medically reasonable and necessary, but only if each
of the following conditions is met:
Angiograms documenting a valid obstruction should show not only the aortic
arch with the vessels off the arch, but also show the vessels in the neck and
head (providing biplane views of the carotid and vertebral vascular system). In
addition, serial views are needed to diagnose "subclavian steal," the condition
in which subclavian artery obstruction causes the symptoms of vertebral artery
obstruction. Because the symptoms are not specific for vertebral artery
obstruction, other causes must be considered. In addition to vertebral artery
obstruction, the differential diagnosis should include various degenerative
disorders of the brain, orthostatic hypotension, acoustic neuroma,
labyrinthitis, diabetes mellitus and hypoglycemia related disorders.
Obstructions which can cause symptoms of blocked vertebral artery blood flow
and which can be documented by an angiogram include:
o Intravascular obstructions - arteriosclerotic lesions within
the vertebral artery or in other
o Extravascular obstructions -
o Bony tissue or osteophytes, located laterally in the
C6(C7)-C2 cervical vertebral area course of the vertebral artery, most commonly
at C5 -
o Anatomical variations - Anomalous location of the origin of the vertebral artery, a congenital aberration, and tortuosity and kinks of the vertebral artery.
o Fibrous tissue - Tissue changed as a result of manipulation of the neck for neck pain or injury associated with hematoma; external bands, tendinous slings, and fibrous bands.
The most controversial obstructions include vertebral artery tortuosity and
kinks and connective tissue along the course of the vertebral artery, and
variously called external bands, tendinous slings and fibrous bands. In the
absence of symptoms of vertebral artery obstruction, vascular surgeons feel such
abnormalities are insignificant. Vascular surgery experts, however, agree that
these abnormalities in very rare cases do cause symptoms of vertebral artery
obstruction and do necessitate surgical correction.
Vertebral artery construction and vertebral artery surgery are phrases which
most physicians interpret to include only surgical cleaning (endarterectomy) and
bypass (resection) procedures. However, some physicians who use these terms mean
all operative manipulations which remove vertebral artery blood flow
obstructions. Also, some physicians use general terms of vascular surgery, such
as endarterectomy when vertebral artery related surgery is performed. Use of the
above terminology specifies neither the surgical procedure performed nor its
relationship to the vertebral artery. Therefore, in developing claims for this
type of procedure, require specific identification of the obstruction in
question and the surgical procedure performed. Also, in view of the specific
coverage criteria given, develop all claims for vertebral artery surgery on a
Make payment for a surgical procedure listed above if: (1) it is reasonable
and necessary for the individual patient to have the surgery performed to remove
or relieve an obstruction to vertebral artery flow, and (2) the four conditions
noted are met.
In all other cases, these procedures cannot be considered reasonable and
necessary within the meaning of §1862(a)(1) of the Act and are not reimbursable
under the program.
35-33 INTESTINAL BY-PASS SURGERY--NOT
The safety of intestinal bypass surgery for treatment of obesity has not been
demonstrated. Severe adverse reactions such as steatorrhea, electrolyte
depletion, liver failure, arthralgia, hypoplasia of bone marrow, and
avitaminosis have sometimes occurred as a result of this procedure. It does not
meet the reasonable and necessary provisions of §1862(a)(1) of the Act and is
not a covered Medicare procedure.
Cross-refer: §§ 35-26, 35-40
35-34 FABRIC WRAPPING OF ABDOMINAL
Fabric wrapping of abdominal aneurysms is not a covered Medicare procedure.
This is a treatment for abdominal aneurysms which involves wrapping aneurysms
with cellophane or fascia lata. This procedure has not been shown to prevent
eventual rupture. In extremely rare instances, external wall reinforcement may
be indicated when the current accepted treatment (excision of the aneurysm and
reconstruction with synthetic materials) is not a viable alternative, but
external wall reinforcement is not fabric wrapping. Accordingly, fabric wrapping
of abdominal aneurysms is not considered reasonable and necessary within the
meaning of §1862(a)(1) of the Act.
35-35 THERAPEUTIC EMBOLIZATION (Effective
for services performed on or after April 15, 1982.)
Therapeutic embolization is covered when done for hemorrhage, and for other
conditions amenable to treatment by the procedure, when reasonable and necessary
for the individual patient. Renal embolization for the treatment of renal
adenocarcinoma continues to be covered, effective December 15, 1978, as one type
of therapeutic embolization, to:
o Reduce tumor
o Reduce tumor bulk in inoperable cases; or
o Palliate specific symptoms.
EXTRACRANIAL-INTRACRANIAL (EC-IC) ARTERIAL BYPASS SURGERY
(Effective for services performed on or after March 27, 1991)
Extracranial-Intracranial (EC-IC) arterial bypass surgery
is not a covered procedure when it is performed as a treatment for ischemic
cerebrovascular disease of the carotid or middle cerebral arteries, which
includes the treatment or prevention of strokes. The premise that this procedure
which bypasses narrowed arterial segments improves the blood supply to the brain
and reduces the risk of having a stroke has not been demonstrated to be any more
effective than no surgical intervention. Accordingly, EC-IC arterial bypass
surgery is not considered reasonable and necessary within the meaning of
§1862(a)(1) of the Act when it is performed as a treatment for ischemic
cerebrovascular disease of the carotid or middle cerebral
35-38 ULTRAFILTRATION, HEMOPERFUSION AND
A. Ultrafiltration.--This is a
process for removing excess fluid from the blood through the dialysis membrane
by means of pressure. It is not a substitute for dialysis. Ultrafiltration is
utilized in cases where excess fluid cannot be removed easily during the regular
course of hemodialysis. When it is performed, it is commonly done during the
first hour or two of each hemodialysis on patients who, e.g., have refractory
edema. Ultrafiltration is a covered procedure under the Medicare program
(effective for services performed on and after 9/1/79).
Predialysis Ultrafiltration.--While this procedure requires additional
staff care, the facility dialysis rate is intended to cover the full range of
complicated and uncomplicated nonacute dialysis treatments. Therefore, no
additional facility charge is recognized for predialysis ultrafiltration. The
physician's role in ultrafiltration varies with the stability of the patient's
condition. In unstable patients, the physician may need to be present at the
initiation of dialysis, and available either in- house or in close proximity to
monitor the patient carefully. In patients who are relatively stable, but who
seem to accumulate excessive weight gain, the procedure requires only a modest
increase in physician involvement over routine outpatient hemodialysis.
Occasionally, medical complications may occur which require that
ultrafiltration be performed separate from the dialysis treatment, and in these
cases an additional charge can be recognized. However, the claim must be
documented as to why the ultrafiltration could not have been performed at the
same time as the dialysis.
B. Hemoperfusion.--This is a
process which removes substances from the blood using a charcoal or resin
artificial kidney. When used in the treatment of life threatening drug
overdose, hemoperfusion is a covered service for patients with or without
renal failure (effective for services performed on and after 9/1/79).
Hemoperfusion generally requires a physician to be present to initiate treatment
and to be present in the hospital or an adjacent medical office during the
entire procedure, as changes may be sudden. Special staff training and equipment
Develop charges for hemoperfusion in the same manner as for any new or
unusual service. One or two treatments are usually all that is necessary to
toxic compound; document additional treatments. Hemoperfusion may be performed concurrently with dialysis, and in those cases payment for the hemoperfusion reflects only the additional care rendered over and above the care given with dialysis.
The effects of using hemoperfusion to improve the results of
chronic hemodialysis are not known. Therefore, hemoperfusion is not a
covered service when used to improve the results of hemodialysis. In addition,
it has not been demonstrated that the use of hemoperfusion in conjunction with
deferoxamine (DFO), in treating symptomatic patients with iron overload, is
efficacious. There is also a paucity of data regarding its efficacy in treating
asymptomatic patients with iron overload. Therefore, hemoperfusion used in
conjunction with DFO in treating patients with iron overload is not a covered
service; i.e., it is not considered reasonable and necessary within the meaning
of §1862(a)(1) of the Act.
However, the use of hemoperfusion in conjunction with DFO for the treatment
of patients with aluminum toxicity has been demonstrated to be clinically
efficacious and is therefore regarded as a covered service.
C. Hemofiltration.--This is a
process which removes fluid, electrolytes and other low molecular weight toxic
substances from the blood by filtration through hollow artificial membranes and
may be routinely performed in 3 weekly sessions. Hemofiltration (which is also
known as diafiltration) is a covered procedure under Medicare and is a safe and
effective technique for the treatment of ESRD patients and an alternative to
peritoneal dialysis and hemodialysis (effective for services performed on and
after August 20, 1987). In contrast to both hemodialysis and peritoneal dialysis
treatments, which eliminate dissolved substances via diffusion across
semipermeable membranes, hemofiltration mimics the filtration process of the
normal kidney. The technique requires an arteriovenous access. Hemofiltration
may be performed either in facility or at home.
The procedure is most advantageous when applied to high-risk unstable
patients, such as older patients with cardiovascular diseases or diabetes,
because there are fewer side effects such as hypotension, hypertension or volume
35-39 INTRAOCULAR PHOTOGRAPHY (Effective
for Services Furnished on or After September 1, 1979)
Intraocular photography is covered when used for the diagnosis of such
conditions as macular degeneration, retinal neoplasms, choroid disturbances and
diabetic retinopathy, or to identify glaucoma, multiple sclerosis and other
central nervous system abnormalities. Make Medicare payment for the use of this
procedure by an opthalmologist in these situations when it is reasonable and
necessary for the individual patient to receive these services.
35-40 GASTRIC BYPASS SURGERY FOR OBESITY
(Effective for Services Performed on and After October 1, 1979)
Gastric bypass surgery, which is a variation of the gastrojejunostomy, is performed for patients with extreme obesity. Gastric bypass surgery for extreme obesity is
covered under the program if (1) it is medically appropriate for the
individual to have such surgery; and (2) the surgery is to correct an illness
which caused the obesity or was aggravated by the obesity.
Cross-refer: §§ 35-26, 35-33
35-4l DIATHERMY TREATMENT
High energy pulsed wave diathermy machines have been found to produce some
degree of therapeutic benefit for essentially the same conditions and to the
same extent as standard diathermy. Accordingly, where the contractor's medical
staff has determined that the pulsed wave diathermy apparatus used is one which
is considered therapeutically effective, the treatments are considered a covered
service, but only for those conditions for which standard diathermy is medically
indicated and only when rendered by a physician or incident to a physician's
professional services. Further, when the charge for covered pulsed wave
diathermy treatment is substantially in excess of that which is reasonable for
standard diathermy, payment is based on the reasonable charge for standard
diathermy (CPT-4 code 97024, ICD-9-CM code 93.34).
35-42 WITHDRAWAL TREATMENTS FOR NARCOTIC
Withdrawal is an accepted treatment for narcotic addiction, and Part B
payment can be made for these services if they are provided by the physician
directly or under his personal supervision and if they are reasonable and
necessary. In reviewing claims, reasonableness and necessity are determined with
the aid of the contractor's medical staff.
Drugs that the physician provides in connection with this treatment are also
covered if they cannot be self-administered and meet all other statutory
Cross-refer: Intermediary Manual, §3112.4B; Carriers Manual, §2050.5.
35-44 USE OF VISUAL
TESTS PRIOR TO AND GENERAL ANESTHESIA DURING CATARACT
A. Pre-Surgery Evaluations (Effective for Services Performed On or After 09-l4-88).-- Cataract surgery with an intraocular lens (IOL) implant is a high volume Medicare procedure. Along with the surgery, a substantial number of preoperative tests are available to the surgeon. In most cases, a comprehensive eye examination (ocular history and ocular examination) and a single scan to determine the appropriate pseudophakic power of the IOL are sufficient. In most cases involving a simple cataract, a diagnostic ultrasound A-scan is used. For patients with a dense cataract, an ultrasound B-scan may be used.
Accordingly, where the only diagnosis is cataract(s), Medicare does not
routinely cover testing other than one comprehensive eye examination (or a
combination of a brief/intermediate examination not to exceed the charge of a
comprehensive examination) and an A-scan or, if medically justified, a B-scan.
Claims for additional tests are denied as not reasonable and necessary unless
there is an additional diagnosis and the medical need for the additional
tests is fully documented.
Because cataract surgery is an elective procedure, the patient may decide not to have the surgery until later, or to have the surgery performed by a physician other than the diagnosing physician. In these situations, it may be medically appropriate for the operating physician to conduct another examination. To the extent the additional tests are considered reasonable and necessary by the carrier's medical staff, they are covered.
B. General Anesthesia.--The use
of general anesthesia in cataract surgery may be considered reasonable and
necessary if, for particular medical indications, it is the accepted procedure
among ophthalmologists in the local community to use general anesthesia. In the
claims review process, do not "front-end" reject any claims for the use of
general anesthesia in cataract surgery. Obtain advice from your medical
consultants before deciding whether to deny a claim involving use of general
anesthesia in cataract surgery. Where regular postpayment review discloses a
questionable utilization pattern, obtain case documentation.
35-45 CARDIAC CATHETERIZATION PERFORMED
IN OTHER THAN A HOSPITAL SETTING (Effective for services performed on or after
Cardiac catheterization performed in a hospital setting for either inpatients or outpatients is a covered service. The procedure may also be covered when performed in a freestanding clinic when the carrier, in consultation with the appropriate Peer Review Organization (PRO), determines that the procedure can be performed safely in all respects in the particular facility. Prior to approving Medicare payment for cardiac catheterizations performed in freestanding clinics, carriers must request PRO review of the clinic.
35-46 ASSESSING PATIENT'S SUITABILITY FOR
ELECTRICAL NERVE STIMULATION THERAPY
Electrical nerve stimulation is an accepted modality for assessing a patient's suitability for ongoing treatment with a transcutaneous or an implanted nerve stimulator. Accordingly, program payment may be made for the following techniques when used to determine the potential therapeutic usefulness of an electrical nerve stimulator:
A. Transcutaneous Electrical Nerve
Stimulation (TENS).--This technique involves attachment of a transcutaneous
nerve stimulator to the surface of the skin over the peripheral nerve to be
stimulated. It is used by the patient on a trial basis and its effectiveness in
modulating pain is monitored by the physician, or physical therapist. Generally,
the physician or physical therapist is able to determine whether the patient is
likely to derive a significant therapeutic benefit from continuous use of a
transcutaneous stimulator within a trial period of 1 month; in a few cases this
determination may take longer to make. Document the medical necessity for such
services which are furnished beyond the first month. (See §45-25 for an
explanation of coverage of medically necessary supplies for the effective use of
|NOTE:||Electrical nerve stimulators do not prevent pain but only alleviate pain as it occurs. A patient can be taught how to employ the stimulator, and once this is done, can use it safely and effectively without direct physician supervision. Consequently, it is inappropriate for a patient to visit his/her physician, physical therapist, or an outpatient clinic on a continuing basis for treatment of pain with electrical nerve stimulation. Once it is determined that electrical nerve stimulation should be continued as therapy and the patient has been trained to use the stimulator, it is expected that a stimulator will be implanted or the patient will employ the TENS on a continual basis in his/her home. Electrical nerve stimulation treatments furnished by a physician in his/her office, by a physical therapist or outpatient clinic are excluded from coverage by §1862(a)(1) of the Act. (See §65-8 for an explanation of coverage of the therapeutic use of implanted peripheral nerve stimulators under the prosthetic devices benefit. See §60-20 for an explanation of coverage of the therapeutic use of TENS under the durable medical equipment benefit.)|
o The hospital
is able to provide the specialized facilities, services, and personnel that are
required by pediatric liver transplant patients.
35-54 REFRACTIVE KERATOPLASTY- NOT COVERED
Refractive keratoplasty is surgery to reshape the cornea of the eye to
correct vision problems such as myopia (nearsightedness) and hyperopia
(farsightedness). Refractive keratoplasty procedures include keratomileusis, in
which the front of the cornea is removed, frozen, reshaped, and stitched back on
the eye to correct either near or farsightedness; keratophakia, in which a
reshaped donor cornea is inserted in the eye to correct farsightedness; and
radial keratotomy, in which spoke-like slits are cut in the cornea to weaken and
flatten the normally curved central portion to correct nearsightedness.
The correction of common refractive errors by eyeglasses,
contact lenses or other prosthetic devices is specifically excluded from
coverage. The use of radial keratotomy and/or keratoplasty for the purpose of
refractive error compensation is considered a substitute or alternative to eye
glasses or contact lenses, which are specifically excluded by §1862 (a)(7) of
the Act (except in certain cases in connection with cataract surgery). In
addition, many in the medical community consider such procedures cosmetic
surgery, which is excluded by section §1862 (a)(10) of the Act. Therefore,
radial keratotomy and keratoplasty to treat refractive defects are not
Keratoplasty that treats specific lesions of the cornea,
such as phototherapeutic keratectomy that removes scar tissue from the visual
field, deals with an abnormality of the eye and is not cosmetic surgery. Such
cases may be covered under §1862(a)(1)(A) of the Act.
The use of lasers to treat ophthalmic disease constitutes
opthalmalogic surgery. Coverage is restricted to practitioners who have
completed an approved training program in ophthalmologic
35-55 TRANSVENOUS (CATHETER) PULMONARY EMBOLECTOMY - NOT COVERED
Transvenous (catheter) pulmonary embolectomy is a procedure for removing
pulmonary emboli by passing a catheter through the femoral vein. It is not
covered under Medicare because it is still experimental.
35-56 FLUIDIZED THERAPY DRY HEAT FOR
CERTAIN MUSCULOSKELETAL DISORDERS
Fluidized therapy is a high intensity heat modality consisting of a dry whirlpool of finely divided solid particles suspended in a heated air stream, the mixture having the properties of a liquid. Use of fluidized therapy dry heat is covered as an acceptable alternative to other heat therapy modalities in the treatment of acute or subacute traumatic or nontraumatic musculoskeletal disorders of the extremities.
35-57 ELECTROENCEPHALOGRAPHIC MONITORING
DURING SURGICAL PROCEDURES INVOLVING THE CEREBRAL
Electroencephalographic (EEG) monitoring is a safe and reliable technique for the assessment of gross cerebral blood flow during general anesthesia and is covered under Medicare. Very characteristic changes in the EEG occur when cerebral perfusion is inadequate for cerebral function. EEG monitoring as an indirect measure of cerebral perfusion requires the expertise of an electroencephalographer, a neurologist trained in EEG, or an advanced EEG technician for its proper interpretation.
35-57.1 ELECTROENCEPHALOGRAPHIC (EEG)
MONITORING DURING OPEN-HEART SURGERY - NOT COVERED
The value of EEG monitoring during open heart surgery and in the immediate post-operative period is debatable because there are little published data based on well designed studies regarding its clinical effectiveness. The procedure is not frequently used and does not enjoy widespread acceptance of benefit.
Accordingly, Medicare does not cover EEG monitoring during open heart surgery
and during the immediate post-operative period.
35-58 THORACIC DUCT DRAINAGE (TDD) IN
Thoracic duct drainage (TDD) is an immunosuppressive technique used in renal
transplantation. This procedure, which removes lymph from kidney transplant
recipients as a means of achieving suppression of the immune mechanism, is
currently being used both pre-transplant and post- transplant in conjunction
with more conventional immunotherapy. TDD is performed on an inpatient basis,
and the inpatient stay is covered for patients admitted for treatment in advance
of a kidney transplant as well as for those receiving it
TDD is a covered technique when furnished to a kidney transplant recipient or
an individual approved to receive kidney transplantation in a hospital approved
to perform kidney transplantation.
Endoscopy is a technique in which a long flexible tube-like instrument is
inserted into the body orally or rectally, permitting visual inspection of the
gastrointestinal tract. Although primarily a diagnostic tool, endoscopy includes
certain therapeutic procedures such as removal of polyps, and endoscopic
papillotomy, by which stones are removed from the bile duct.
Endoscopic procedures are covered when reasonable and necessary for the
35-60 APHERSIS (THERAPEUTIC
A. General.--Apheresis (also
known as pheresis or therapeutic pheresis) is a medical procedure utilizing
specialized equipment to remove selected blood constituents (plasma, leukocytes,
platelets, or cells) from whole blood. The remainder is retransfused into the
person from whom the blood was taken.
For purposes of Medicare coverage, apheresis is defined as an autologous
procedure, i.e., blood is taken from the patient, processed, and returned to the
patient as part of a continuous procedure (as distinguished from the procedure
in which a patient donates blood preoperatively and is transfused with the
donated blood at a later date).
B. Indications.--Apheresis is
covered for the following indications:
Settings.--Apheresis is covered only when performed in the following
- A physician (or a number of physicians) is present to
perform medical services and to respond to medical emergencies at all
times during patient care
- Each patient is under the care of a physician; and
- All nonphysician services are furnished under the direct, personal supervision of a physician.
35-61 TRANSSEXUAL SURGERY
Transsexual surgery, also known as sex reassignment surgery or intersex
surgery, is the culmination of a series of procedures designed to change the
anatomy of transsexuals to conform to their gender identity. Transsexuals are
persons with an overwhelming desire to change anatomic sex because of their
fixed conviction that they are members of the opposite sex. For the
male-to-female, transsexual surgery entails castration, penectomy and
vulva-vaginal construction. Surgery for the female-to-male transsexual consists
of bilateral mammectomy, hysterectomy and salpingo- oophorectomy, which may be
followed by phalloplasty and the insertion of testicular prostheses.
Transsexual surgery for sex reassignment of transsexuals is controversial.
Because of the lack of well controlled, long term studies of the safety and
effectiveness of the surgical procedures and attendant therapies for
transsexualism, the treatment is considered experimental. Moreover, there is a
high rate of serious complications for these surgical procedures. For these
reasons, transsexual surgery is not covered.
35-62 INVASIVE INTRACRANIAL PRESSURE
Invasive intracranial pressure monitoring is a safe and effective therapeutic
tool used to monitor intracranial pressure. It is usually used for patients
suffering from head injuries, subarachnoid hemorrhage, intracerebral hemorrhage,
Reye's syndrome, or posthypoxic, metabolic, and viral encephalopathies. It is
usually performed in specialized intensive care units for neurosurgical and
neurologic patients. It is a covered procedure when reasonable and necessary for
the individual patient.
35-63 TINNITUS MASKING
A tinnitus masker is a device designed to be worn like a behind-the-ear
hearing aid by persons seeking relief from tinnitus. Tinnitus is the perception
of noise in the ear and/or head area. The masker produces external sounds to
distract the person from the tinnitus.
By producing an external sound a few decibels above the person's audible
threshhold, tinnitus masking is thought to provide sufficient distraction from
subjective idiopathic tinnitus to alleviate the discomfort and debilitation
associated with endogenous sounds within the ear and/or head area.
Tinnitus masking is considered an experimental therapy at this time because
of the lack of controlled clinical trials demonstrating effectiveness and the
unstudied possibility of serious toxicity in the form of noise induced hearing
loss. Therefore, it is not covered.
35-64 CHELATION THERAPY FOR TREATMENT OF
Chelation therapy is the application of chelation techniques for the
therapeutic or preventive effects of removing unwanted metal ions from the body.
The application of chelation therapy using ethylenediamine-tetra-acetic acid
(EDTA) for the treatment and prevention of atherosclerosis is controversial.
There is no widely accepted rationale to explain the beneficial effects
attributed to this therapy. Its safety is questioned and its clinical
effectiveness has never been established by well designed, controlled clinical
trials. It is not widely accepted and practiced by American physicians. EDTA
chelation therapy for atherosclerosis is considered experimental. For these
reasons, EDTA chelation therapy for the treatment or prevention of
atherosclerosis is not covered.
Some practitioners refer to this therapy as chemoendarterectomy and may also
show a diagnosis other than atherosclerosis, such as arteriosclerosis or
calcinosis. Claims employing such variant terms should also be denied under this
35-65 GASTRIC FREEZING
Gastric freezing for chronic peptic ulcer disease is a non-surgical treatment
which was popular about 20 years ago but now is seldom done. It has been
abandoned due to a high complication rate, only temporary improvement
experienced by patients, and lack of effectiveness when tested by double- blind,
controlled clinical trials. Since the procedure is now considered obsolete, it
is not covered.
35-66 TREATMENT OF PSORIASIS
Psoriasis is a chronic skin disease, for which several conventional methods
of treatment have been recognized as covered. These include topical application
of steroids or other drugs; ultraviolet light (actinotherapy); and coal tar
alone or in combination with ultraviolet B light (Goeckerman treatment).
A newer treatment for psoriasis uses a psoralen derivative drug in combination with ultraviolet A light, known as PUVA. PUVA therapy is covered for treatment of intractable, disabling psoriasis, but only after the psoriasis has not responded to more conventional treatment. The contractor should document this before paying for PUVA therapy.
In addition, reimbursement for PUVA therapy should be limited to amounts paid
for other types of photochemotherapy; ordinarily, payment should not be allowed
for more than 30 days of treatment, unless improvement is documented.
Melodic intonation therapy is a technique used in language rehabilitation.
Its purpose is to teach aphasic patients to produce useful phrases by intoning
them in a melodic pattern with strong rhythmic support. Limited studies by a few
institutions show some benefit for a small number of nonfluent aphasic patients
otherwise unresponsive to conventional therapy.
Melodic intonation therapy is a covered service only for nonfluent aphasic
patients unresponsive to conventional therapy, and only when the conditions for
coverage of speech pathology services are met. Please refer to HCFA-Pub. 14-3,
§§2200-2206.4, and 2216, HCFA-Pub. 13-3, §§3101.10A, and 3147-3148.4; or
HCFA-Pub. 10 §§241-242.5 for these conditions of coverage.
35-86 GASTRIC BALLOON FOR TREATMENT OF
The gastric balloon is a medical device developed for use as a temporary
adjunct to diet and behavior modification to reduce the weight of patients who
fail to lose weight with those measures alone. It is inserted into the stomach
to reduce the capacity of the stomach and to affect early satiety.
The use of the gastric balloon is not covered under Medicare, since the long
term safety and efficacy of the device in the treatment of obesity has not been
35-87 HEART TRANSPLANTS--(Effective for
services rendered on or after October 17, 1986.)
A. General.--Cardiac transplantation is covered under Medicare when performed in a facility which is approved by Medicare as meeting institutional coverage criteria. (See HCFA Ruling 87-1.)
B. Exceptions.--In certain
limited cases, exceptions to the criteria may be warranted if there is
justification and if the facility ensures our objectives of safety and efficacy.
Under no circumstances will exceptions be made for facilities whose transplant
programs have been in existence for less than two years, and applications from
consortia will not be approved.
Although consortium arrangements will not be approved for payment of Medicare
heart transplants, consideration will be given to applications from heart
transplant facilities that consist of more than one hospital where all of
the following conditions exist:
o The hospitals
are under the common control or have a formal affiliation arrangement with each
other under the auspices of an organization such as a university or a
legally-constituted medical research institute; and
o The hospitals
share resources by routinely using the same personnel or services in their
transplant programs. The sharing of resources must be supported by the
submission of operative notes or other information that documents the routine
use of the same personnel and services in all of the individual hospitals. At a
minimum, shared resources means:
- The individual members of the transplant team, consisting of
the cardiac transplant surgeons, cardiologists and pathologists, must practice
in all the hospitals and it can be documented that they otherwise function as
members of the transplant team; and
- The same organ procurement organization, immunology, and
tissue-typing services must be used by all the hospitals; and
o The hospitals
submit, in the manner required (Kaplan-Meier method) their individual and pooled
experience and survival data; and
o The hospitals
otherwise meet the remaining Medicare criteria for heart transplant facilities;
that is, the criteria regarding patient selection, patient management, program
C. Pediatric Hospitals.--Cardiac
transplantation is covered for Medicare beneficiaries when performed in a
pediatric hospital that performs pediatric heart transplants if the hospital
submits an application which HCFA approves as documenting that:
o The hospital's
pediatric heart transplant program is operated jointly by the hospital and
another facility that has been found by HCFA to meet the institutional coverage
criteria in HCFA Ruling 87-1;
o The unified
program shares the same transplant surgeons and quality assurance program
(including oversight committee, patient protocol, and patient selection
o The hospital
is able to provide the specialized facilities, services, and personnel that are
required by pediatric heart transplant patients.
D. Follow-up Care.--Follow-up
care required as a result of a covered heart transplant is covered, provided
such services are otherwise reasonable and necessary. Follow-up care is also
covered for patients who have been discharged from a hospital after receiving a
noncovered heart transplant. Coverage for follow-up care would be for items and
services that are reasonable and necessary, as determined by Medicare
guidelines. (See Intermediary Manual §3101.l4 and Carriers Manual
E. Immunosuppressive Drugs.--(See
Intermediary Manual §3660.8 and Carriers Manual §§2050.5, 4471 and
F. Artificial Hearts.--Medicare
does not cover the use of artificial hearts or ventricular assist devices,
either as a permanent replacement for a human heart or as a temporary
life-support system until a human heart becomes available for transplant (often
referred to as a "bridge to transplant"). (See §65-15.)
35-88 EXTRACORPOREAL PHOTOPHERESIS
(Effective for services performed on or after April 8, 1988.)
Extracorporeal photopheresis is a treatment for cutaneous T-cell lymphoma (CTCL), a condition that is generally resistant to chemotherapy and radiotherapy. The treatment begins with the oral administration of the drug methoxsalen. The patient's blood is then passed through a device that permits exposure of the blood, while it is outside the body (extracorporeal), to ultraviolet A light. The blood is then returned to the patient.
Extracorporeal photopheresis is covered by Medicare only when used in the
palliative treatment of the skin manifestations of CTCL that has not responded
to other therapy.
35-89 SPEECH PATHOLOGY SERVICES FOR THE
TREATMENT OF DYSPHAGIA
(Effective for services performed on and after 08/28/89)
Dysphagia is a swallowing disorder that may be due to various neurological, structural, and cognitive deficits. Dysphagia may be the result of head trauma, cerebrovascular accident, neuromuscular degenerative diseases, head and neck cancer, and encephalopathies. While dysphagia can afflict any age group, it most often appears among the elderly. Speech pathology services are covered under Medicare for the treatment of dysphagia, regardlessof
the presence of a communication disability.
Patients who are motivated, moderately alert, and have some degree of
deglutition and swallowing functions are appropriate candidates for dysphagia
therapy. Elements of the therapy program can include thermal stimulation to
heighten the sensitivity of the swallowing reflex, exercises to improve
oral-motor control, training in laryngeal adduction and compensatory swallowing
techniques, and positioning and dietary modifications. Design all programs to
ensure swallowing safety of the patient during oral feedings and maintain
Cross-refer: Intermediary Manual, §3101.l0A; Carriers Manual, §2216; Hospital
Manual, §210.11; Home Health Agency Manual, §205.2C.; Skilled Nursing Facility
Manual, §230.3B.; Outpatient Physical Therapy and Comprehensive Outpatient
Rehabilitation Facility Manual, §205.6.
35-90 EXTRACORPOREAL IMMUNOADSORPTION
(ECI) USING PROTEIN A COLUMNS FOR THE TREATMENT OF PATIENTS WITH IDIOPATHIC
THROMBOCYTOPENIA PURPURA (ITP) FAILING OTHER TREATMENTS (Effective for services
performed on and after 5/6/91)
Extracorporeal immunoadsorption (ECI), using Protein A columns, has been developed for the purpose of selectively removing circulating immune complexes (CIC) and immunoglobulins (IgG) from patients in whom these substances are associated with their diseases. The technique involves pumping the patient's anticoagulated venous blood through a cell separator from which 1-3 liters of plasma are collected and perfused over adsorbent columns, after which the plasma rejoins the separated, unprocessed cells and is retransfused to the patient.
The use of protein A columns is covered by Medicare only for the treatment of
ITP failing other treatments. Other uses of these columns are currently
considered to be investigational and, therefore, not reasonable and necessary
under the Medicare law. (See §1862(a)(1)(A) of the Act.)
Until a national code is issued, use the following Q code (temporary
plasmapheresis; immunoadsorption with staphylococcal protein A
This code will facilitate data keeping in order to help evaluate this new technology.
35-91 LAPAROSCOPIC CHOLECYSTECTOMY
(Effective for services performed on and after November 18,
Laparoscopic cholecystectomy is a covered surgical procedure in which a diseased gall bladder is removed through the use of instruments introduced via cannulae, with vision of the operative field maintained by use of a high-resolution television camera-monitor system (video laparoscope). For inpatient claims, use ICD-9-CM code 51.23, Laparoscopic cholecystectomy. For all other claims, use CPT codes 49310 for laparoscopy, surgical; cholecystectomy (any method), and 49311 for laparoscopy, surgical: cholecystectomy with cholangiography.
35-92 TRANSCENDENTAL MEDITATION -
Transcendental meditation (TM) is a skill that is claimed to produce a state
of rest and relaxation when practiced effectively. Typically, patients are
taught TM techniques over the course of several sessions by persons trained in
TM. The patient then uses the TM technique on his or her own to induce the
relaxed state. Proponents of TM have urged that Medicare cover the training of
patients to practice TM when it is medically prescribed as treatment for mild
hypertension, as adjunctive therapy in the treatment of essential hypertension,
or as the sole or adjunctive treatment of anxiety and other psychological
After review of this issue, HCFA has concluded that the evidence concerning
the medical efficacy of TM is incomplete at best and does not demonstrate
effectiveness and that a professional level of skill is not required for the
training of patients to engage in TM.
Although many articles have been written about application of TM for patients
with certain forms of hypertension and anxiety, there are no rigorous scientific
studies that demonstrate the effectiveness of TM for use as an adjunct medical
therapy for such conditions. Accordingly, neither TM nor the training of
patients for its use are covered under the Medicare program.
35-93 LUNG VOLUME
REDUCTION SURGERY (REDUCTION PNEUMOPLASTY, ALSO CALLED LUNG SHAVING OR LUNG
CONTOURING) UNILATERAL OR BILATERAL BY OPEN OR THORACOSCOPIC APPROACH FOR
TREATMENT OF EMPHYSEMA OR CHRONIC OBSTRUCTIVE PULMONARY DISEASE - NOT GENERALLY
Lung volume reduction surgery (LVRS) or reduction pneumoplasty, also referred to as lung shaving or lung contouring, is performed on patients with emphysema and chronic obstructive pulmonary disease (COPD) in order to allow the underlying compressed lung to expand, and thus, establish improved respiratory function. The goal of this procedure is to offer a better quality of life for patients with emphysema and COPD. In addition, LVRS may be offered as a "bridge to transplant" for patients who otherwise may not have been considered candidates for lung transplantation.
Unilateral or bilateral LVRS by open or thoracoscopic
approach is not generally covered, because there is insufficient medical
evidence available to base a determination that this procedure is generally safe
and effective. Therefore, LVRS generally cannot be considered reasonable and
necessary under §1862(a)(1)(A) of the Act in most cases.
When this policy was first established in December 1995,
HCFA committed Medicare to reviewing the scientific literature as it was
published in order to modify coverage policy as clinical data were developed.
HCFA has reviewed data that suggest the need for a randomized clinical trial
regarding the safety and effectiveness of LVRS. On April 24, 1996, the Health
Care Financing Administration (HCFA) and the National Heart, Lung and Blood
Institute (NHLBI) of the National Institutes of Health announced their intention
to collaborate on a multi-center, randomized clinical study evaluating the
effectiveness of LVRS. On December 20, 1996, HCFA and NHLBI announced the
clinical centers and the data coordinating center that will be participating in
the study. HCFA has determined that LVRS is reasonable and necessary when it is
provided under the conditions detailed by the protocol of the HCFA/NHLBI
clinical study. Therefore, Medicare will cover LVRS in those limited
circumstances when it is provided to a Medicare beneficiary under the protocols
established for the study. Coverage will be provided where the care is furnished
in facilities that are approved as meeting the criteria established by HCFA and
NHLBI for this study.
This study will consist of a registry of all patients referred to the
participating clinical centers for LVRS. In addition, a subset of patients from
the registry who meet specific inclusion criteria will be invited to participate
in the randomized trial. All randomized patients will receive intensive medical
therapy and pulmonary rehabilitation. Half will be selected randomly to undergo
LVRS, which will be performed via median sternotomy or video-assisted
Medicare will provide coverage to those beneficiaries who may participate in
the randomized trial for all services integral to the study and for which the
Medicare statute does not prohibit. This includes tests performed to determine
whether a beneficiary qualifies for randomization, LVRS, and follow-up tests
that are necessary during participation in the randomized study. However,
Medicare will not provide coverage for those services that are prohibited by the
Act. For example, Medicare will provide coverage for pulmonary rehabilitation
and pulmonary function testing, but will not provide coverage for
oral steroids provided as part of a physician's service under §1862(s)(2) of the
Act because they are self-administrable and thus statutorily excluded from
Payment for these services will be provided under the usual payment systems.
For example, Part A services will be paid for according to the DRG system, and
Part B physician services will be paid for according to the physician fee
The data from the randomized phase of the study will be analyzed and
monitored continuously in order to determine any appropriate changes in Medicare
coverage. These determinations will include if and how coverage will be
continued. Transmyocardial revascularization (TMR) is a surgical technique which uses a
laser to bore holes through the myocardium of the heart in an attempt to restore
perfusion to areas of the heart not being reached by diseased or clogged
arteries. This technique is used as a late or last resort for relief of symptoms
of severe angina in patients with ischemic heart disease not amenable to direct
coronary revascularization interventions, such as angioplasty, stenting or open
coronary bypass. The precise workings of this technique are not certain. The original theory
upon which the technique was based, that the open channels would result in
increased perfusion of the myocardium, does not appear to be the major or only
action at work. Several theories have been proposed, including partial
denervation of the myocardium, or the triggering of the cascade of biological
reactions which encourage increased development of blood vessels. However, research at several facilities indicates that, despite this
uncertainty, the technique does offer relief of angina symptoms for a period of
time in patients for whom no other medical treatment offering relief is
available. Studies indicate that both reduction in pain and reduction in
hospitalizations are significant for most patients treated. Consequently, we
have concluded that, for patients with severe angina (Class III or IV, Canadian
Cardiovascular Society, or similar classification system) for whom all other
medical therapies have been tried or evaluated and found insufficient, such
therapy offers sufficient evidence of its medical effectiveness to treat the
symptomatology. It is important to note that this technique does not provide for
increased life expectancy, nor is it proven to affect the underlying cause of
the angina. However, it appears effective in treating the symptoms of angina,
and reducing hospitalizations and allowing patients to resume some of their
normal activities of daily living.
35-94 TRANSMYOCARDIAL REVASCULARIZATION (TMR) FOR TREATMENT OF SEVERE ANGINA--COVERED (Effective for services performed on or after July 1, 1999)
Transmyocardial revascularization (TMR) is a surgical technique which uses a laser to bore holes through the myocardium of the heart in an attempt to restore perfusion to areas of the heart not being reached by diseased or clogged arteries. This technique is used as a late or last resort for relief of symptoms of severe angina in patients with ischemic heart disease not amenable to direct coronary revascularization interventions, such as angioplasty, stenting or open coronary bypass.
The precise workings of this technique are not certain. The original theory upon which the technique was based, that the open channels would result in increased perfusion of the myocardium, does not appear to be the major or only action at work. Several theories have been proposed, including partial denervation of the myocardium, or the triggering of the cascade of biological reactions which encourage increased development of blood vessels.
However, research at several facilities indicates that, despite this uncertainty, the technique does offer relief of angina symptoms for a period of time in patients for whom no other medical treatment offering relief is available. Studies indicate that both reduction in pain and reduction in hospitalizations are significant for most patients treated. Consequently, we have concluded that, for patients with severe angina (Class III or IV, Canadian Cardiovascular Society, or similar classification system) for whom all other medical therapies have been tried or evaluated and found insufficient, such therapy offers sufficient evidence of its medical effectiveness to treat the symptomatology. It is important to note that this technique does not provide for increased life expectancy, nor is it proven to affect the underlying cause of the angina. However, it appears effective in treating the symptoms of angina, and reducing hospitalizations and allowing patients to resume some of their normal activities of daily living.
We therefore cover TMR as a late or last resort for patients with severe (Canadian Cardiovascular Society classification Classes III or IV) angina (stable or unstable), which has been found refractory to standard medical therapy, including drug therapy at the maximum tolerated or maximum safe dosages. In addition, the angina symptoms must be caused by areas of the heart not amenable to surgical therapies such as percutaneous transluminal coronary angioplasty, stenting, coronary atherectomy or coronary bypass. Coverage is further limited to those uses of the laser used in performing the procedure which have been approved by the Food and Drug Administration for the purpose for which they are being used.
Patients would have to meet the following additional selection guidelines:
1. An ejection fraction of 25% or greater;
2. Have areas of viable ischemic myocardium (as demonstrated by diagnostic study) which are not capable of being revascularized by direct coronary intervention; and,
3. Have been stabilized, or have had maximal efforts to stabilize acute conditions such as severe ventricular arrhythmias, decompensated congestive heart failure or acute myocardial infarction.
Coverage is limited to physicians who have been properly trained in the procedure. Providers of this service is performed must also document that all ancillary personnel, including physicians, nurses, operating room personnel and technicians, are trained in the procedure and the proper use of the equipment involved. Coverage is further limited to providers which have dedicated cardiac care units, including the diagnostic and support services necessary for care of patients undergoing this therapy. In addition, these providers must conform to the standards for laser safety set by the American National Standards Institute, ANSIZ1363.35-95 PARTIAL VENTRICULECTOMY (ALSO KNOWN AS VENTRICULAR REDUCTION, VENTRICULAR REMODELING, OR HEART VOLUME REDUCTION SURGERY) - NOT COVERED
Since the mortality rate is high and there are no published scientific
articles or clinical studies regarding partial ventriculectomy, this procedure
cannot be considered reasonable and necessary within the meaning of §1862(a)(1)
of the Act. Therefore, partial ventriculectomy is not covered by Medicare.
35-96 CRYOSURGERY OF PROSTATE Effective for services performed on or after July 1, 1999)
Cryosurgery of the prostate gland, also known as cryosurgical ablation of the prostate (CSAP), destroys prostate tissue by applying extremely cold temperatures in order to reduce the size of the prostate gland. It is safe and effective, as well as medically necessary and appropriate, as primary treatment for patients with clinically localized prostate cancer, Stages T1-T3.
35-97 VERTEBRAL AXIAL DECOMPRESSION
(VAX-D) - NOT COVERED
Vertebral axial decompression is performed for symptomatic relief of pain associated with lumbar disk problems. The treatment combines pelvic and/or cervical traction connected to a special table that permits the traction application. There is insufficient scientific data to support the benefits of this technique. Therefore, VAX-D is not covered by Medicare.
35-98 ELECTROSTIMULATION IN THE
TREATMENT OF WOUNDS - NOT COVERED
Electrical stimulation (ES) has been used or studied for many different applications, one of which is accelerating wound healing. The types of ES used for healing chronic venous and arterial wound and pressure ulcers are direct current (DC), alternating current (AC), pulsed current (PC), pulsed electromagnetic induction (PEMI), and spinal cord stimulation (SCS). An example of AC is transcutaneous electrical stimulation (TENS). The PEMI includes Pulsed Electromagnetic Field (PEMF) and Pulsed Electromagnetic Energy (PEE) using pulsed radio frequency energy, both of which are nonthermal i.e., they do not produce heat. Some ES use generators to create energy in the radio frequency band, delivered in megahertz (MHz). They typically deliver energy by contacting means such as coils, rather than by leads or surface electrodes.
There is insufficient evidence to determine any clinically significant
differences in healing rates. Therefore, ES cannot be covered by Medicare
because its effectiveness has not been adequately demonstrated.
Abortions are not covered Medicare procedures except
1. if the pregnancy is the result of an act of rape or incest; or
2. in the case where a woman suffers from a physical disorder, physical injury, or physical illness, including a life-endangering physical condition caused by or arising from the pregnancy itself, that would, as certified by a physician, place the woman in danger of death unless an abortion is performed.
This restricted coverage applies to CPT codes 59840, 59841, 59850, 59851, 59852, 59855, 59856, 59857, and 59866.