(Medicare Benefit Policy Manual)

1. Criteria -One:   The patient must either:   - Because of illness or injury, need the aid of supportive devices such as crutches, canes, wheelchairs, and walkers; the use of special transportation; or the assistance of another person in order to leave their place of residence   OR  - Have a condition such that leaving his or her home is medically contraindicated.   If the patient meets one of the Criteria -One conditions, then the patient must ALSO meet two additional requirements defined in Criteria -Two below.   2. Criteria -Two:   - There must exist a normal inability to leave home;  AND   - Leaving home must require a considerable and taxing effort.   If the patient does in fact leave the home, the patient may nevertheless be considered homebound if the absences from the home are infrequent or for periods of relatively short duration, or are attributable to the need to receive health care treatment.  Ab sences attributable to the need to receive health care treatment include, but are not limited to:    Attendance at adult day centers to receive medical care;    Ongoing receipt of outpatient kidney dialysis; or    The receipt of outpatient chemotherapy or radiation therapy.   Any absence of an individual from the home attributable to the need to receive health care treatment, including regular absences for the purpose of participating in therapeutic, psychosocial, or medical treatment in an adult day- care program that is licens ed or certified by a State, or accredited to furnish adult day- care services in a state, shall not disqualify an individual from being considered to be confined to his home.  Any other absence of an individual from the home shall not so disqualify an individual if the absence is of an infrequent or of relatively short duration.  For purposes of the preceding sentence, any absence for the purpose of attending a religious service shall be deemed to be an absence of infrequent or short duration.  It is expected that in most instances, absences from the home that occur will be for the purpose of receiving health care treatment.  However, occasional absences from the home for nonmedical purposes, e.g., an occasional trip to the barber, a walk around the block or a drive, attendance at a family reunion, funeral, graduation, or other infrequent or unique event would not necessitate a finding that the patient is not homebound if the absences are undertaken on an infrequent basis or are of relatively short duration and do not indicate that the patient has the capacity to obtain the health care provided outside rather than in the home. Some examples of homebound patients that illustrate the factors used to determine whether a homebound condition exists would be:    A patient paralyzed from a stroke who is confined to a wheelchair or requires the aid of crutches in order to walk;    A patient who is blind or senile and requires the assistance of another person in leaving his or her place of residence;    A patient who has lost the use of the upper extremities and, therefore, is unable to open doors, use handrails on stairways, etc., requires the assistance of another individual to leave his or her place of residence;    A patient in the late stages of ALS or neurodegenerative disabilities.  In determining whether the patient has the general inability to leave the home and leaves the home only infrequently or for periods of short duration, it is necessary to look at the pa tients condition over a period of time rather than for short periods within the home health stay.  For example, a patient may leave the home (under the conditions described above, e.g., with severe and taxing effort, with the assistance of others) more frequently during a short period when, for example, the presence of visiting relatives provides a unique opportunity for such absences, than is normally the case.  So long as the patients overall condition and experience is such that he or she meets these qualifications, he or she should be considered confined to the home.    A patient who has just returned from a hospital stay involving surgery who may be suffering from resultant weakness and pain and, therefore, his or her actions may be restricted by the physician to certain specified and limited activities such as getting o ut of bed only for a specified period of time, or walking stairs only once a day, etc.;    A patient with arteriosclerotic heart disease of such severity that the beneficiary must avoid all stress and physical activity; and   A patient with a psychiatric illness that is manifested in part by a refusal to leave home or is of such a nature that it would not be considered safe for the patient to leave home unattended, even if he or she had no physical limitations.   The aged person who does not often travel from home because of feebleness and insecurity brought on by advanced age would not be considered confined to the home for purposes of this reimbursement unless they meet one of the above conditions above.  70 - Sleep Disorder Clinics  (Rev. 1, 10- 01-03) B3-2055  Sleep disorder clinics are facilities in which certain conditions are diagnosed through the study of sleep.  Such clinics are for diagnosis, therapy, and research.  Sleep disorder clinics may provide some diagnostic or therapeutic services, which are cover ed under Medicare.  These clinics may be affiliated either with a hospital or a freestanding facility.  Whether a clinic is hospital -affiliated or freestanding, coverage for diagnostic services under some circumstances is covered under provisions of the la w different from those for coverage of therapeutic services.   A.  Criteria for Coverage of Diagnostic Tests   All reasonable and necessary diagnostic tests given for the medical conditions listed in subsection B are covered when the following criteria are met:    The clinic is either affiliated with a hospital or is under the direction and control of physicians. Diagnostic testing routinely performed in sleep disorder clinics may be covered even in the absence of direct supervision by a physician;   Patients are referred to the sleep disorder clinic by their attending physicians, and the clinic maintains a record of the attending physicians orders; and   The need for diagnostic testing is confirmed by medical evidence, e.g., physician examinations and laboratory tests.  Diagnostic testing that is duplicative of previous testing done by the attending physician to the extent the results are still pertinent is not covered because it is not reasonable and necessary under 1862(a)(1)(A) of the Act.   B.  Medical Conditions for Which Testing is Covered   Diagnostic testing is covered only if the patient has the symptoms or complaints of one of the conditions listed below.  Most of the patients who undergo the diagnostic testing are not considered inpatients, although they may come to the facility in the ev ening for testing and then leave after testing is over.  The overnight stay is considered an integral part of these tests.  1. Narcolepsy - This term refers to a syndrome that is characterized by abnormal sleep tendencies, e.g., excessive daytime sleepiness or disturbed nocturnal sleep.  Related diagnostic testing is covered if the patient has inappropriate sleep episodes or attacks (e.g., while driving, in the middle of a meal, in the middle of a conversation), amnesiac episodes, or continuous disabling drowsiness.  The sleep disorder clinic must submit documentation that this condition is severe enough to interfere with the patients well being and health before Medicare benefits may be provided for diagnostic testing.  Ordinarily, a diagnosis of narcolepsy can be confirmed by three sleep naps.  If more than three sleep naps are claimed, the A/B MAC (B) will require persuasive medical evidence justifying the medical necessity for the additional test(s).  It will use HCPCS procedure codes 95828 and 95805.  2. Sleep Apnea  - This is a potentially lethal condition where the patient stops breathing during sleep.  Three types of sleep apnea have been described (central, obstructive, and mixed).  The nature of the apnea episodes can be documented by appropriate diagnostic testing.  Ordinarily, a single polysomnogram and electroencephalogram (EEG) can diagnose sleep apnea.  If more than one such testing session is claimed, the A/B MAC (B) will require persuasive medical evidence justifying the medical necessity for the additional tests.  It will use HCPCS procedure codes 95807, 95810, and 95822.  3. Impotence - Diagnostic nocturnal penile tumescence testing may be covered, under limited circumstances, to determine whether erectile impotence in men is organic or psychogenic.  Although impotence is not a sleep disorder, the nature of the testing requires that it be performed during sleep.  The tests ordinarily are covered only where necessary to confirm the treatment to be given (surgical, medical, or psychotherapeutic).  Ordinarily, a diagnosis may be determined by two nights of diagnostic testing.  If more than two nights of testing are claimed, the A/B MAC (B) will require persuasive medical evidence justifying the medical necessity for the additional tests.  It will have its medical staff review questionable cases to ensure that the tests are reaso nable and necessary for the individual.  It will use HCPCS procedure code 54250. (See the Medicare National Coverage Determinations Manual, Chapter 1, for policy on coverage of diagnosis and treatment of impotence.)  4. Parasomnia - Parasomnias are a group of conditions that represent undesirable or unpleasant occurrences during sleep.  Behavior during these times can often lead to damage to the surroundings and injury to the patient or to others.  Parasomnia may include conditions such as sleepwalking, sleep terrors, and rapid eye movement (REM) sleep behavior disorders.  In many of these cases, the nature of these conditions may be established by careful clinical evaluation.  Suspected seizure disorders as possible ca use of the parasomnia are appropriately evaluated by standard or prolonged sleep EEG studies.  In cases where seizure disorders have been ruled out and in cases that present a history of repeated violent or injurious episodes during sleep, polysomnography may be useful in providing a diagnostic classification or prognosis.  The A/B MAC (B) must use HCPCS procedure codes 95807, 95810, and/or 95822.  C.  Polysomnography for Chronic Insomnia Is Not Covered.  Evidence at the present time is not convincing that polysomnography in a sleep disorder clinic for chronic insomnia provides definitive diagnostic data or that such information is useful in patient treatment or is associated with improved clinical outcome.   The use of polysomnography for diagnosis of patients with chronic insomnia is not covered under Medicare because it is not reasonable and necessary under 1862(a)(1)(A) of the Act.   D.  Coverage of Therapeutic Services.  Sleep disorder clinics may at times render therapeutic as well as diagnostic services.  Therapeutic services may be covered in a hospital outpatient setting or in a freestanding facility provided they meet the pertinent requirements for the particular type of services and are reasonable and necessary for the patient, and are performed under the direct supervision of a physician.  80 - Requirements for Diagnostic X- Ray, Diagnostic Laboratory, and Other Diagnostic Tests  (Rev.  11901; Issued: 03-16- 23; Effective: 01 -01-21; Implementation: 05-17-23)    This section describes the levels of physician supervision required for furnishing the technical component of diagnostic tests for a Medicare beneficiary who is not a hospital inpatient.  For hospital outpatient diagnostic services, the supervision levels assigned to each CPT or Level II HCPCS code in the Medicare Physician Fee Schedule Relative  Value File that is updated quarterly, apply as described below.  For more information, see Chapter 6 (Hospital Services Covered Under Part B), 20.4 (Outpatient Diagnostic Services).    Section 410.32(b) of the Code of Federal Regulations (CFR) requires that diagnostic tests covered under 1861(s)(3) of the Act and payable under the physician fee schedule, with certain exceptions listed in the regulation, have to be performed under the supervision of an individual meeting the definition of a physician (1861(r) of the Act) to be considered reasonable and necessary and, therefore, covered under Medicare.   However, effective January 1, 2021, the basic rule at 42 CFR 410.32(b)(1) requires that diagnostic tests covered under 1861(s)(3) of the Act and payable under the physician fee schedule must be furnished under the appropriate level of supervision by a physician as defined in 1861(r) of the Act or, to the extent that they are authorized to do so under their scope of practice and applicable State law, by a nurse practitioner, clinical nurse specialist, certified nurse -midwife, certified registered nurse anesthetist or physician assistant. Services furnished without the required level of supervision are not reasonable and necessary.      The regulation defines these levels of supervision for diagnostic tests as follows:    General Supervision - means the procedure is furnished under the physicians overall direction and control, but the physicians presence is not required during the performance of the procedure.  Under general supervision, the training of the nonphysician personnel who actually performs the diagnostic procedure and the maintenance of the necessary equipment and supplies are the continuing responsibility of the physician.    Direct Supervision - in the office setting means the physician (or other supervising practitioner) must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure.  It does not mean that the physician (or other supervising practitioner) must be present in the room when the procedure is performed.   Personal Supervision - means a physician must be in attendance in the room during the performance of the procedure.    One of the following numerical levels is assigned to each CPT or HCPCS code in the Medicare Physician Fee Schedule Database:    0 Procedure is not a diagnostic test or procedure is a diagnostic test which is not subject to the physician supervision policy.