(Medicare Benefit Policy Manual)

80.4.1 - Diagnostic X- Ray Tests  (Rev. 1, 10-01-03) B3-2070.4.A  Diagnostic x-ray services furnished by a portable x-ray supplier are covered under Part B when furnished in a place or residence used as the patients home and in nonparticipating institutions.  These services must be performed under the general supervision of a physician, the supplier must meet FDA certification requirements, and certain conditions relating to health and safety (as prescribed by the Secretary) must be met.  Diagnostic portable x-ray services are also covered under Part B when provided in participating SNFs and hospitals, under circumstances in which they cannot be covered under hospital insurance, i.e., the services are not furnished by the participating institution either directly or under arrangements that provide for the institution to bill for the services.  (See 250 for Part B services furnished to inpatients of participating and nonparticipating institutions.)  80.4.2 - Applicability of Health and Safety Standards  (Rev. 1, 10-01-03) B3-2070.4.B  The health and safety standards apply to all suppliers of portable x-ray services, except physicians who provide immediate personal supervision during the administration of diagnostic x -ray services.  Payment is made only for services of approved suppliers who have been found to meet the standards.  Notice of the coverage dates for services of approved suppliers are given to A/B MACs (B) by the RO.  When the services of a supplier of portable x-ray services no longer meet the conditions of coverage, physicians having an interest in the suppliers certification status must be notified.  The notification action regarding suppliers of portable x-ray equipment is the same as required for decertification of independent laboratories, and the procedures explained in 80.1.3 are followed.   80.4.3 - Scope of Portable X- Ray Benefit  (Rev. 71, Issued: 05-25-07, Effective: N/A; Implementation: July 2, 2007)  In order to avoid payment for services, which are inadequate or hazardous to the patient, the scope of the covered portable x -ray benefit is defined as:    Skeletal films involving the extremities, pelvis, vertebral column, or skull;   Chest films which do not involve the use of contrast media (except routine screening procedures and tests in connection with routine physical examinations);   Abdominal films which do not involve the use of contrast media; and   Diagnostic mammograms if the approved portable x-ray supplier, as defined in 42 CFR part 486, subpart C, meets the certification requirements of section 354 of the Public Health Services Act, as implemented by 21 CFR part 900, subpart B.  80.4.4 - Exclusions From Coverage as Portable X-Ray Services (Rev. 1, 10-01-03) B3-2070.4.D  Procedures and examinations which are not covered under the portable x-ray provision include the following:   Procedures involving fluoroscopy;   Procedures involving the use of contrast media;   Procedures requiring the administration of a substance to the patient or injection of a substance into the patient and/or special manipulation of the patient;   Procedures which require special medical skill or knowledge possessed by a doctor of medicine or doctor of osteopathy or which require that medical judgment be exercised;   Procedures requiring special technical competency and/or special equipment or materials;   Routine screening procedures; and   Procedures which are not of a diagnostic nature.  80.4.5 - Electrocardiograms  (Rev. 1, 10-01-03) B3-2070.4.F  The taking of an electrocardiogram tracing by an approved supplier of portable x- ray services may be covered as an other diagnostic test.  The health and safety standards referred to in 80.4.2 are applicable to such diagnostic EKG services, e.g., the technician must meet the personnel qualification requirements in the conditions for coverage of portable x- ray services.   80.5 - Bone Mass Measurements (BMMs)  (Rev.70, Issued: 05-11- 07, Effective: 01 -01-07, Implementation: 07-02-07)   80.5.1 - Background  (Rev. 70, Issued: 05-11- 07, Effective: 01 -01-07, Implementation: 07-02-07)   On June 24, 1998, CMS published an Interim Final Rule with Comment Period (IFC) in the Federal Register entitled "Medicare Coverage of and Payment for Bone Mass Measurements."  This IFC implemented section 4106 of the Balanced Budget Act of 1997 by establishing conditions for coverage and frequency standards thereby providing uniform coverage under Medicare Part B.  It was effective July1, 1998.  On December 1, 2006, CMS published the CY 2007 Physician Fee Schedule final rule.  This rule implemented several changes effective January 1, 2007, which are reflected below.   80.5.2 - Authority  (Rev. 70, Issued: 05-11- 07, Effective: 01 -01-07, Implementation: 07-02-07)   Definitions can be found in sections 1861(s)(15) and (rr)(1) of the Social Security Act (the Act).  Conditions for coverage and frequency standards can be found in 42 CFR 410.31.  Denials as not reasonable and necessary can be found at 1862(a)(1)(A) of the Act, 42 CFR 410.31(e), and 42 CFR 411.15(k).  80.5.3 - Definition  (Rev. 70, Issued: 05-11- 07, Effective: 01 -01-07, Implementation: 07-02-07)   BMM means a radiologic, radioisotopic, or other procedure that meets all of the following conditions:   Is performed to identify bone mass, detect bone loss, or determine bone quality.   Is performed with either a bone densitometer (other than single-photon or dual-photon absorptiometry) or a bone sonometer system that has been cleared for marketing for BMM by the Food and Drug Administration (FDA) under 21 CFR part 807, or approved for marketing under 21 CFR part 814.   Includes a physicians interpretation of the results.  80.5.4 - Conditions for Coverage  (Rev. 70, Issued: 05-11- 07, Effective: 01 -01-07, Implementation: 07-02-07)   Medicare covers BMM under the following conditions:  1. Is ordered by the physician or qualified nonphysician practitioner who is treating the beneficiary following an evaluation of the need for a BMM and determination of the appropriate BMM to be used.  A physician or qualified nonphysician practitioner treating the beneficiary for purposes of this provision is one who furnishes a consultation or treats a beneficiary for a specific medical problem, and who uses the results in the management of the patient.  For the purposes of the BMM benefit, qualified nonphysician practitioners include physician assistants, nurse practitioners, clinical nurse specialists, and certified nurse midwives.   2. Is performed under the appropriate level of physician supervision as defined in 42 CFR 410.32(b).  3. Is reasonable and necessary for diagnosing and treating the condition of a beneficiary who meets the conditions described in 80.5.6.  4. In the case of an individual being monitored to assess the response to or efficacy of an FDA-approved osteoporosis drug therapy, is performed with a dual-energy x-ray absorptiometry system (axial skeleton).  5. In the case of any individual who meets the conditions of 80.5.6 and who has a confirmatory BMM, is performed by a dual-energy x- ray absorptiometry system (axial skeleton) if the initial BMM was not performed by a dual-energy x-ray absorptiometry system (axial skeleton).  A confirmatory baseline BMM is not covered if the initial BMM was performed by a dual- energy x -ray absorptiometry system (axial skeleton).   80.5.5 - Frequency Standards  (Rev. 70, Issued: 05-11- 07, Effective: 01 -01-07, Implementation: 07-02-07)   Medicare pays for a screening BMM once every 2 years (at least 23 months have passed since the month the last covered BMM was performed).   When medically necessary, Medicare may pay for more frequent BMMs.  Examples include, but are not limited to, the following medical circumstances:    Monitoring beneficiaries on long-term glucocorticoid (steroid) therapy of more than 3 months.   Confirming baseline BMMs to permit monitoring of beneficiaries in the future.   80.5.6 - Beneficiaries Who May be Covered  (Rev. 70, Issued: 05- 11-07, Effective: 01 -01-07, Implementation: 07- 02-07)  To be covered, a beneficiary must meet at least one of the five conditions listed below:   1. A woman who has been determined by the physician or qualified nonphysician practitioner treating her to be estrogen- deficient and at clinical risk for osteoporosis, based on her medical history and other findings.  NOTE:  Since not every woman who has been prescribed estrogen replacement therapy (ERT) may be receiving an adequate dose of the therapy, the fact that a woman is receiving ERT should not preclude her treating physician or other qualified treating nonphysician practitioner from ordering a bone mass measurement for her.  If a BMM is ordered for a woman following a careful evaluation of her medical need, however, it is expected that the ordering treating physician (or other qualified treating nonphysician pr actitioner) will document in her medical record why he or she believes that the woman is estrogen -deficient and at clinical risk for osteoporosis.  2. An individual with vertebral abnormalities as demonstrated by an x- ray to be indicative of osteoporosis, osteopenia, or vertebral fracture.   3. An individual receiving (or expecting to receive) glucocorticoid (steroid) therapy equivalent to an average of 5.0 mg of prednisone, or greater, per day, for more than 3 months.  4. An individual with primary hyperparathyroidism.  5. An individual being monitored to assess the response to or efficacy of an FDA -approved osteoporosis drug therapy.   80.5.7 - Noncovered BMMs (Rev. 70, Issued: 05- 11-07, Effective: 01 -01-07, Implementation: 07- 02-07)  The following BMMs are noncovered under Medicare because they are not considered reasonable and necessary under section 1862(a)(1)(A) of the Act.   Single photon absorptiometry (effective January 1, 2007).  Dual photon absorptiometry (established in 1983).   80.5.8 - Claims Processing  (Rev. 70, Issued: 05- 11-07, Effective: 01 -01-07, Implementation: 07- 02-07)  For instructions concerning payment methodology, HCPCS coding, and Medicare summary notice and remittance advice messages, see chapter 13, section 140 of Pub. 100- 04, Medicare Claims Processing Manual.   80.5.9 - National Coverage Determinations (NCDs)  (Rev. 70, Issued: 05- 11-07, Effective: 01 -01-07, Implementation: 07- 02-07)  In addition to these conditions for coverage, CMS may determine through the NCD process that additional BMM systems are reasonable and necessary under section 1862(a)(1) of the Act for monitoring and confirming baseline BMMs.  80.6 - Requirements for Ordering and Following Orders for Diagnostic Tests  (Rev. 80; Issued:  01- 11-08; Effective:  01 -01-03; Implementation:  11 -19-07)  The following sections provide instructions about ordering diagnostic tests and for complying with such orders for Medicare payment.   NOTE:  Unless specified, these sections are not applicable in a hospital setting.  80.6.1 - Definitions  (Rev. 94, Issued: 08- 29-08, Effective: 01- 01-03, Implementation: 09- 30-08)  Diagnostic Test   A diagnostic test includes all diagnostic x -ray tests, all diagnostic laboratory tests, and other diagnostic tests furnished to a beneficiary.   Treating Physician   A treating physician is a physician, as defined in 1861(r) of the Social Security Act (the Act), who furnishes a consultation or treats a beneficiary for a specific medical problem, and who uses the results of a diagnostic test in the management of the beneficiarys specific medical problem.   A radiologist performing a therapeutic interventional procedure is considered a treating physician.  A radiologist performing a diagnostic interventional or diagnostic procedure is not considered a treating physician.  Treating Practitioner