42 CFR § 410.32 - Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions. | Electronic Code of Federal Regulations (e-CFR) | US Law | LII / Legal Information Institute

 410.32   Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.(a)Ordering diagnostic tests.Except as otherwise provided in this section, all diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests must be ordered by thephysicianwho is treating thebeneficiary, that is, thephysicianwho furnishes a consultation or treats abeneficiaryfor a specific medical problem and who uses the results in the management of thebeneficiary's specific medical problem. Tests not ordered by thephysicianwho is treating thebeneficiaryare not reasonable and necessary (see 411.15(k)(1)of this chapter).(1)Mammography exception.Aphysicianwho meets the qualificationrequirementsfor an interpretingphysicianunder section 354 of thePublic Health Service Actas provided in 410.34(a)(7)may order a diagnostic mammogram based on the findings of a screening mammogram even though thephysiciandoes not treat thebeneficiary.(2)Application to nonphysician practitioners.Nonphysician practitioners(that is, clinical nurse specialists, clinical psychologists, clinical social workers, marriage and family therapists, mental health counselors, nurse-midwives, nurse practitioners, andphysicianassistants) who furnishservicesthat would bephysicianservicesif furnished by aphysician, and who are operating within the scope of their authority under State law and within the scope of theirMedicarestatutory benefit, may be treated the same asphysicianstreating beneficiaries for the purpose of this paragraph.(3)Public Health Emergency exceptions.During thePublic Health Emergencyfor COVID19, as defined in 400.200of this chapter, the order of aphysicianor other applicablepractitioneris not required for one otherwise covered diagnostic laboratory test for COVID19 and for one otherwise covered diagnostic laboratory test each for influenza virus or similar respiratory condition needed to obtain a final COVID19 diagnosis when performed in conjunction with COVID19 diagnostic laboratory test in order to rule-out influenza virus or related diagnosis. Subsequent otherwise covered COVID19 and related tests described in the previous sentence are reasonable and necessary when ordered by aphysicianornonphysician practitionerin accordance with this paragraph (a), or when ordered by a pharmacist or other healthcare professional who is authorized under applicable state law to order diagnostic laboratory tests.FDA-authorized COVID19 serology tests are included as covered tests subject to the same orderrequirementsduring thePublic Health Emergencyfor COVID19, as defined in 400.20of this chapter, as they are reasonable and necessary under section 1862(a)(1)(A) of theActfor beneficiaries with known current or known prior COVID19 infection or suspected current or suspected prior COVID19 infection.(4)Application to audiologists.Except as otherwise provided in this paragraph, audiologists may personally furnish diagnostic audiology tests for apatientonce perpatientper 12-month period without an order from thephysicianornonphysician practitionertreating thepatient. Such diagnostic audiology tests can be for non-acute hearing conditions, but may not include audiologyservicesthat are related to disequilibrium, or hearing aids, or examinations for the purpose of prescribing, fitting, or changing hearing aids that are outlined at 411.15(d). Audiologyservicesfurnished without an order from the treatingphysicianorpractitionerare billed using a modifierCMSdesignates for this purpose.(b)Diagnostic x-ray and other diagnostic tests (1)Basic rule.Except as indicated inparagraph (b)(2)of this section, all diagnostic x-ray and other diagnostic tests covered under section 1861(s)(3) of theActand payable under thephysicianfee schedule must be furnished under the appropriate level of supervision by aphysicianas defined in section 1861(r) of theActor, to the extent that they are authorized to do so under their scope of practice and applicable State law, by a nursepractitioner, clinical nurse specialist,physicianassistant,certified registered nurse anesthetist, or a certified nurse-midwife.Servicesfurnished without the required level of supervision are not reasonable and necessary (see 411.15(k)(1)of this chapter).(2)Exceptions.The following diagnostic tests payable under thephysicianfee schedule are excluded from thebasic ruleset forth in paragraph (b)(1) of this section:(i)Diagnostic mammography procedures, which are regulated by theFood and Drug Administration.(ii)Diagnostic tests personally furnished by a qualified audiologist as defined in section 1861(ll)(3) of theAct.(iii)Diagnostic psychological and neuropsychological testingserviceswhen(A)Personally furnished by a clinical psychologist or an independently practicing psychologist as defined in program instructions; or(B)Furnished under the general supervision of aphysicianor clinical psychologist; or under the general supervision of a nursepractitioner, clinical nurse specialist,physicianassistant,certified registered nurse anesthetistor certified nurse-midwife, to the extent they are authorized to perform the tests under their scope of practice and applicable State laws.(iv)Diagnostic tests (as established through program instructions) personally performed by a physical therapist who is certified by the American Board of Physical Therapy Specialties as a qualified electrophysiologic clinical specialist and permitted to provide theserviceunder State law.(v)Diagnostic tests performed by a nursepractitioneror clinical nurse specialist authorized to perform the tests under applicable State laws.(vi)Pathology and laboratory procedures listed in the 80000 series of the Current Procedural Terminology published by the American Medical Association.(vii)Diagnostic tests performed by a certified nurse-midwife authorized to perform the tests under applicable State laws.(viii)During the COVID19Public Health Emergencyas defined in 400.200of this chapter, diagnostic tests performed by aphysicianassistant authorized to perform the tests under applicable State law.(ix)Diagnostic tests performed by aphysicianassistant authorized to perform the tests under their scope of practice and applicable State laws.(3)Levels of supervision.Except where otherwise indicated, all diagnostic x-ray and other diagnostic tests subject to this provision and payable under thephysicianfee schedule must be furnished under at least a general level of supervision as defined inparagraph (b)(3)(i)of this section. In addition, some of these tests also require either direct or personal supervision as defined in paragraph (b)(3)(ii) or (iii) of this section, respectively. When direct or personal supervision is required, supervision at the specified level is required throughout the performance of the test.(i)General supervisionmeans the procedure is furnished under thephysician's overall direction and control, but thephysician's presence is not required during the performance of the procedure. Under general supervision, the training of the nonphysician personnel who actually perform the diagnostic procedure and the maintenance of the necessary equipment and supplies are the continuing responsibility of thephysician.(ii)Direct supervisionin the office setting means thephysician(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 thephysician(or other supervising practitioner) must be present in the room when the procedure is performed. Through December 31, 2024, the presence of thephysician(or other practitioner) includes virtual presence through audio/video real-time communications technology (excluding audio-only).(iii)Personal supervisionmeans aphysicianmust be in attendance in the room during the performance of the procedure.(4)Supervision requirement for RRA or RPA.Diagnostic tests that are performed by a registered radiologist assistant (RRA) who is certified and registered by the American Registry of Radiologic Technologists or a radiologypractitionerassistant (RPA) who is certified by the Certification Board for RadiologyPractitionerAssistants, and that would otherwise require a personal level of supervision as specified inparagraph (b)(3)of this section, may be furnished under a direct level ofphysiciansupervision to the extent permitted by state law and state scope of practice regulations.(c)Portable x-ray services.Portable x-rayservicesfurnished in a place of residence used as thepatient's home are covered if the following conditions are met:(1)Theseservicesare furnished under the general supervision of aphysician, as defined inparagraph (b)(3)(i)of this section.(2)Theseservicesare ordered by aphysicianas provided in paragraph (a) or by anonphysician practitioneras provided inparagraph (a)(2)of this section.(3)The supplier of theseservicesmeets therequirementsset forth in part 486,subpart Cof this chapter, concerning conditions for coverage for portable x-ray services.(4)The procedures are limited to(i)Skeletal films involving the extremities, pelvis, vertebral column, or skull;(ii)Chest or abdominal films that do not involve the use of contrast media; and(iii)Diagnostic mammograms if the approved portable x-ray supplier, as defined in subpart C ofpart 486of this chapter, meets the certificationrequirementsof section 354 of thePublic Health Service Act, as implemented by21 CFR part 900, subpart B.(d)Diagnostic laboratory tests(1)Who may furnish services.MedicarePart B pays for covered diagnostic laboratory tests that are furnished by any of the following:(i)Aparticipating hospitalorparticipatingRPCH.(ii)A nonparticipatinghospitalthat meets therequirementsforemergencyoutpatientservicesspecified in subpart G ofpart 424of this chapter and the laboratoryrequirementsspecified inpart 493of this chapter.(iii)The office of thepatient's attending or consultingphysicianif thatphysicianis a doctor of medicine, osteopathy, podiatric medicine, dental surgery, or dental medicine.(iv)AnRHC.(v)A laboratory, if it meets the applicablerequirementsfor laboratories ofpart 493of this chapter, including the laboratory of a nonparticipatinghospitalthat does not meet therequirementsforemergencyoutpatientservicesin subpart G ofpart 424of this chapter.(vi)AnFQHC.(vii)AnSNFto its resident under 411.15(p)of this chapter, either directly (in accordance with 483.75(k)(1)(i)of this chapter) or under an arrangement (as defined in 409.3of this chapter) with another entity described in this paragraph.(2)Documentation and recordkeeping requirements(i)Ordering the service.Except for tests described inparagraph (a)(3)of this section, thephysician(or qualifiednonphysician practitioner, as defined inparagraph (a)(2)of this section), who orders theservicemust maintain documentation of medical necessity in thebeneficiary's medical record.(ii)Submitting the claim.Except for tests described inparagraph (a)(3)of this section, the entity submitting the claim must maintain the following documentation:(A)The documentation that it receives from the orderingphysicianornonphysician practitioner.(B)The documentation that the information that it submitted with the claim accurately reflects the information it received from the orderingphysicianornonphysician practitioner.(iii)Requesting additional information.The entity submitting the claim may request additional diagnostic and other medical information to document that theservicesit bills are reasonable and necessary. If the entity requests additional documentation, it must request material relevant to the medical necessity of the specific test(s), taking into consideration current rules and regulations onpatientconfidentiality.(3)Claims review.(i)Documentation requirements.Except for tests described in paragraph (a)(3) introductory text, upon request byCMS, the entity submitting the claim must provide the following information:(A)Documentation of the order for theservicebilled (including information sufficient to enableCMSto identify and contact the orderingphysicianor nonphysician practitioner).(B)Documentation showing accurate processing of the order and submission of the claim.(C)Diagnostic or other medical information supplied to the laboratory by the orderingphysicianornonphysician practitioner, including any ICD9CM code or narrative description supplied.(ii)Services that are not reasonable and necessary.If the documentation provided underparagraph (d)(3)(i)of this section does not demonstrate that theserviceis reasonable and necessary,CMStakes the following actions:(A)Provides the orderingphysicianornonphysician practitionerinformation sufficient to identify the claim being reviewed.(B)Requests from the orderingphysicianornonphysician practitionerthose parts of abeneficiary's medical record that are relevant to the specific claim(s) being reviewed.