evekhm/cms_iom_500 huggingface dataset:
(Medicare Benefit Policy Manual)
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).
(Medicare Benefit Policy Manual)
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)
(Medicare Benefit Policy Manual)
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:
(Medicare Benefit Policy Manual)
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.    1 Procedure must be performed under the general supervision of a physician.    2 Procedure must be performed under the direct supervision of a physician.    3 Procedure must be performed under the personal supervision of a physician.  (For services rendered on or after 01/01/2019 diagnostic imaging procedures performed by a Registered Radiologist Assistant (RRA) who is certified and registered by the American Re gistry of Radiologic Technologists (ARRT) or a Radiology Practitioner Assistant (RPA) who is certified by the Certification Board for Radiology Practitioner Assistants (CBRPA), and is authorized to furnish the procedure under state law, may be performed un der direct supervision).    4 Physician supervision policy does not apply when procedure is furnished by a qualified, independent psychologist or a clinical psychologist or furnished under the general supervision of a clinical psychologist; otherwise must be performed under the general  supervision of a physician.    5 Physician supervision policy does not apply when procedure is furnished by a qualified audiologist; otherwise must be performed under the general supervision of a  physician.    6 Procedure must be performed by a physician or by a physical therapist (PT) who is certified by the American Board of Physical Therapy Specialties (ABPTS) as a qualified electrophysiologic clinical specialist and is permitted to provide the procedure under State law.
(Medicare Benefit Policy Manual)
6a Supervision standards for level 66 apply; in addition, the PT with ABPTS certification may supervise another PT but only the PT with ABPTS certification may bill.   7a Supervision standards for level 77 apply; in addition, the PT with ABPTS certification may supervise another PT but only the PT with ABPTS certification may bill.    9  Concept does not apply.    21 Procedure must be performed by a technician with certification under general supervision of a physician; otherwise must be performed under direct supervision of a physician.    22 Procedure may be performed by a technician with on- line real -time contact with physician.    66 Procedure must be performed by a physician or by a PT with ABPTS certification and certification in this specific procedure.    77 Procedure must be performed by a PT with ABPTS certification or by a PT without certification under direct supervision of a physician, or by a technician with certification under general supervision of a physician.    When nurse practitioners, clinical nurse specialists, and physician assistants personally perform diagnostic tests as provided under 1861(s)(2)(K) of the Act, the supervision requirements under 1861(s)(3) of the Act and under 42 CFR 410.32 do not apply. Rather, these practitioners are authorized to personally perform diagnostic tests under the supervision requirements applicable to their practitioner benefit category pursuant to State scope of practice laws and under the applicable State requirements.    Because the diagnostic tests benefit category set forth in 1861(s)(3) of the Act is separately enumerated and distinct from the incident to benefit category set forth in 1861(s)(2)(A) of the Act, diagnostic tests cannot be billed to the Medicare program as incident to services. Accordingly, the supervision requirements under the incident to benefit category are not applicable to the diagnostic tests benefit category.   80.1 - Clinical Laboratory Services  (Rev. 79; Issued:  10-19- 07; Effective:  01 -01-03; Implementation:  11 -19-07)
(Medicare Benefit Policy Manual)
80.1 - Clinical Laboratory Services  (Rev. 79; Issued:  10-19- 07; Effective:  01 -01-03; Implementation:  11 -19-07)  Section 1833 and 1861  of the Act provides for payment of clinical laboratory services under Medicare Part B. Clinical laboratory services involve the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.  Laboratory services must meet all applicable requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), as set forth at 42 CFR part 493.  Section 1862(a)(1)(A)  of the Act provides that Medicare payment may not be made for services that are not reasonable and necessary.  Clinical laboratory services must be ordered and used promptly by the physician who is treating the beneficiary as described in 42 CFR 410.32(a) , or by a qualified nonphysician practitioner, as described in 42 CFR 410.32(a)(3).  See section 80.6 of this manual for related physician ordering instructions.  See the Medicare Claims Processing Manual Chapter 16 for related claims processing instructions.  80.1.1 - Certification Changes  (Rev. 1, 10-01-03) B3-2070.1.E  Each page of the lists of approved specialties also includes a column Certification Changed in which the following codes are used:  C indicates a change in the laboratorys approved certification since the preceding listing.  A discloses an accretion.   TERM - Laboratory not approved for payment after the indicated date which follows the code. The reason for termination also is given in the following codes:  1. Involuntary termination - no longer meets requirements 2. Voluntary withdrawal 3. Laboratory closed, merged with other interests, or organizational change 4. Ownership change with new ownership participating under different name 5. Ownership change with new owner not participating 6. Change in ownership - new provider number assigned 7. Involuntary termination - failure to abide by agreement 8. Former emergency hospital now fully participating  80.1.2 - A/B MAC (B)  Contacts With Independent Clinical Laboratories  (Rev. 1, 10-01-03) B3-2070.1.F
(Medicare Benefit Policy Manual)
80.1.2 - A/B MAC (B)  Contacts With Independent Clinical Laboratories  (Rev. 1, 10-01-03) B3-2070.1.F  An important role of the A/B MAC (B) is as a communicant of necessary information to independent clinical laboratories.  Experience has shown that the failure to inform laboratories of Medicare regulations and claims processing procedures may have an adverse effect on prosecution of laboratories suspected of fraudulent activities with respect to tests performed by, or billed on behalf of, independent laboratories.  United States Attorneys often have to prosecute under a handicap or may simply refuse to pros ecute cases where there is no evidence that a laboratory has been specifically informed of Medicare regulations and claims processing procedures.  A/B MACs (B) must follow the Provider Education and Training (PET) guidelines to assure that laboratories are aware of Medicare regulations and the A/B MAC (Bs)  policy when any changes are made in coverage policy or claims processing procedures.  The PET guidelines require A/B MACs (B) to use various methods of communication (such as print, Internet, face- to-face instruction).  Newsletters/bulletins that contain program and billing information must be produced at least quarterly and posted on the A/B MAC ( B) Web site where duplicate copies may be obtained.   Some items which should be communicated to laboratories and responsibilities that laboratories are required to perform are:    The requirements to have the same fee schedule for Medicare and private patients;    To specify whether the tests are manual or automated;    To document fully the medical necessity for pickup of specimens from a skilled nursing facility or a beneficiarys home, and    In cases when a laboratory service is referred from one independent laboratory to another independent laboratory, to identify the laboratory actually performing the test.
(Medicare Benefit Policy Manual)
 In cases when a laboratory service is referred from one independent laboratory to another independent laboratory, to identify the laboratory actually performing the test.  Additionally, when A/B MAC (B) professional relations representatives make personal contacts with particular laboratories, the representative should prepare and retain reports of contact indicating dates, persons present, and issues discussed.  Finally, A/B MACs (B) should inform independent laboratories that the Medicare National Coverage Determinations Manual as well as other guidelines contained in the manual for determining medical necessity are on the Web site.  A/B MACs (B) should also publish local guidelines on its Web site; the A/B MAC (B) should not duplicate national instructions here.  Timely paper or electronic communications concerning the Internet publications to independent laboratories new to the A/B MAC (B)s service area are essential.   80.1.3 - Independent Laboratory Service to a Patient in the Patients Home or an Institution  (Rev. 1, 10-01-03) B3-2070.1.G  Where it is medically necessary for an independent laboratory to visit a patient to obtain a specimen, the service would be covered in the following circumstances:  1.  Patient Confined to Home  If a patient is confined to the home or other place of residence used as his or her home (see 60.4.1 for the definition of a homebound patient), medical necessity would exist (e.g., where a laboratory technician draws a blood specimen).  However, where the specimen is a type which would require only the services of a messenger and would not require the skills of a laboratory technician, e.g., urine or sputum, a specimen pickup service would not be considered medically necessary.  2.  Place of Residence is an Institution   Medical necessity could also exist where the patients place of residence is an institution, including a skilled nursing facility that does not perform venipunctures.  This would apply even though the institution meets the basic definition of a skilled nursing facility and would not ordinarily be considered a beneficiarys home.  (This policy is intended for independent laboratories only and does not expand the range of coverage of services to homebound patients under the incident to provision.)  A trip by an independent laboratory technician to a facility (other than a hospital) for the purpose of performing a venipuncture is considered medically necessary only if:
(Medicare Benefit Policy Manual)
a.  The patient was confined to the facility; and   b.  The facility did not have on duty personnel qualified to perform this service.  When facility personnel actually obtained and prepared the specimens for the independent laboratory to pick them up, the laboratory provides this pickup service as a service to the facility in the same manner as it does for physicians.  80.2 - Psychological Tests and Neuropsychological Tests  (Rev. 85, Issued: 02-29- 08, Effective: 01 -01-06, Implementation: 12-28-06)
(Medicare Benefit Policy Manual)
Medicare Part B coverage of psychological tests and neuropsychological tests is authorized under section 1861(s)(3) of the Social Security Act.  Payment for psychological and neuropsychological tests is authorized under section 1842(b)(2)(A) of the Social Security Act.  The payment amounts for the new psychological and neuropsychological tests (CPT codes 96102, 96103, 96119 and 96120) that are effective January 1, 2006, and are billed for tests administered by a technician or a computer reflect a site of se rvice payment differential for the facility and non-facility settings.  Additionally, there is no authorization for payment for diagnostic tests when performed on an incident to basis.  Under the diagnostic tests provision, all diagnostic tests are assigned a certain level of supervision.  Generally, regulations governing the diagnostic tests provision require that only physicians can provide the assigned level of supervision for diagnostic tests.  However, there is a regulatory exception to the supervision requirement for diagnostic psychological and neuropsychological tests in terms of who can provide the supervision.  That is, regulations allow a clinical psychologist (CP) or a physician to perform the general supervision assigned to diagnostic psychological and neuropsychological tests.  In addition, nonphysician practitioners such as nurse practitioners (NPs), clinical nurse specialists (CNSs) and physician assistants (PAs) who personally perform diagnostic psychological and neuropsychological tests are excluded from having to perform these tests under the general supervision of a physician or a CP.  Rather, NPs and CNSs must perform such tests under the requirements of their respective benefit instead of the requirements for diagnostic psychological and neuropsychological tests.  Accordingly, NPs and CNSs must perform tests in collaboration (as defined under Medicare law at section 1861(aa)(6) of the Act) with a physician.  PAs perform tests under the general supervision of a physician as required for services furnished under the PA benefi t.
(Medicare Benefit Policy Manual)
Furthermore, physical therapists (PTs), occupational therapists (OTs) and speech language pathologists (SLPs) are authorized to bill three test codes as sometimes therapy codes.  Specifically, CPT codes 96105, 96110 and 96111 may be performed by these therapists.  However, when PTs, OTs and SLPs perform these three tests, they must be performed under the general supervision of a physician or a CP.  Who May Bill for Diagnostic Psychological and Neuropsychological Tests  CPs - see qualifications under chapter 15, section 160 of the Benefit Policy Manual, Pub. 100-02.   NPs -to the extent authorized under State scope of practice.  See qualifications under chapter 15, section 200 of the Benefit Policy Manual, Pub. 100-02.   CNSs - to the extent authorized under State scope of practice.  See qualifications under chapter 15, section 210 of the Benefit Policy Manual, Pub. 100- 02.   PAs -  to the extent authorized under State scope of practice.  See qualifications under chapter 15, section 190 of the Benefit Policy Manual, Pub. 100- 02.   Independently Practicing Psychologists (IPPs)    PTs, OTs and SLPs -  see qualifications under chapter 15, sections 220- 230.6 of the Benefit Policy Manual, Pub. 100- 02.  Psychological and neuropsychological tests performed by a psychologist (who is not a CP) practicing independently of an institution, agency, or physicians office are covered when a physician orders such tests.  An IPP is any psychologist who is licensed or certified to practice psychology in the State or jurisdiction where furnishing services or, if the jurisdiction does not issue licenses, if provided by any practicing psychologist.  (It is CMS understanding that all States, the District of Columbia, and Puerto Rico license psychologists, but that some trust territories do not.  Examples of psychologists, other than CPs, whose psychological and neuropsychological tests are covered under the diagnostic tests provision include, but are not limited to, educa tional psychologists and counseling psychologists.)