\u00a7 411.15 Particular services excluded from coverage.<\/p>\n\n\n\n
Link to an amendment published at 88 FR 53345<\/a>, Aug. 7, 2023.<\/p>\n\n\n\n The following services are excluded from coverage:<\/p>\n\n\n\n (a)<\/strong> Routine physical checkups such as:<\/p>\n\n\n\n (1)<\/strong> Examinations performed for a purpose other than treatment or diagnosis of a specific illness, symptoms, complaint, or injury, except for screening mammography, colorectal cancer screening tests, screening pelvic exams, prostate cancer screening tests, glaucoma screening exams, ultrasound screening for abdominal aortic aneurysms (AAA), cardiovascular disease screening tests, diabetes screening tests, a screening electrocardiogram, initial preventive physical examinations that meet the criteria specified in paragraphs (k)(6) through (k)(15) of this section, additional preventive services that meet the criteria in \u00a7 410.64<\/a> of this chapter, or annual wellness visits providing personalized prevention plan services.<\/p>\n\n\n\n (2)<\/strong> Examinations required by insurance companies, business establishments, government agencies, or other third parties.<\/p>\n\n\n\n (b)<\/strong> Low vision aid exclusion<\/em><\/strong>\u2014(1) Scope.<\/em> The scope of the eyeglass exclusion encompasses all devices irrespective of their size, form, or technological features that use one or more lens to aid vision or provide magnification of images for impaired vision.<\/p>\n\n\n\n (2)<\/strong> Exceptions.<\/em><\/strong><\/p>\n\n\n\n (i)<\/strong> Post-surgical prosthetic lenses customarily used during convalescence for eye surgery in which the lens of the eye was removed (for example, cataract surgery).<\/p>\n\n\n\n (ii)<\/strong> Prosthetic intraocular lenses and one pair of conventional eyeglasses or contact lenses furnished subsequent to each cataract surgery with insertion of an intraocular lens.<\/p>\n\n\n\n (iii)<\/strong> Prosthetic lenses used by Medicare beneficiaries who are lacking the natural lens of the eye and who were not furnished with an intraocular lens.<\/p>\n\n\n\n (c)<\/strong> Eye examinations<\/em><\/strong> for the purpose of prescribing, fitting, or changing eyeglasses or contact lenses for refractive error only and procedures performed in the course of any eye examination to determine the refractive state<\/a> of the eyes, without regard to the reason for the performance of the refractive procedures. Refractive procedures are excluded even when performed in connection with otherwise covered diagnosis or treatment of illness or injury.<\/p>\n\n\n\n (d)<\/strong> Hearing aids<\/em><\/strong> or examinations for the purpose of prescribing, fitting, or changing hearing aids.<\/p>\n\n\n\n (1)<\/strong> Scope.<\/em><\/strong> The scope of the hearing aid exclusion encompasses all types of air conduction hearing aids that provide acoustic energy to the cochlea via stimulation of the tympanic membrane with amplified sound and bone conduction hearing aids that provide mechanical stimulation of the cochlea via stimulation of the scalp with amplified mechanical vibration or by direct contact with the tympanic membrane or middle ear ossicles.<\/p>\n\n\n\n (2)<\/strong> Devices not subject to the hearing aid exclusion.<\/em><\/strong> Paragraph (d)(1)<\/a> of this section shall not apply to the following devices that produce the perception of sound by replacing the function of the middle ear, cochlea, or auditory nerve:<\/p>\n\n\n\n (i)<\/strong> Osseointegrated implants in the skull bone that provide mechanical energy to the cochlea via a mechanical transducer, or<\/p>\n\n\n\n (ii)<\/strong> Cochlear implants and auditory brainstem implants that replace the function of cochlear structures or auditory nerve and provide electrical energy to auditory nerve fibers and other neural tissue via implanted electrode arrays.<\/p>\n\n\n\n (e)<\/strong> Immunizations, except for<\/em><\/strong>\u2014<\/p>\n\n\n\n (1)<\/strong> Vaccinations or inoculations directly related to the treatment of an injury or direct exposure such as antirabies treatment, tetanus antitoxin or booster vaccine, botulin antitoxin, antivenom sera, or immune globulin;<\/p>\n\n\n\n (2)<\/strong> Pneumococcal vaccinations that are reasonable and necessary for the prevention of illness;<\/p>\n\n\n\n (3)<\/strong> Hepatitis B vaccinations that are reasonable and necessary for the prevention of illness for those individuals, as defined in \u00a7 410.63(a)<\/a> of this chapter, who are at high or intermediate risk of contracting hepatitis B;<\/p>\n\n\n\n (4)<\/strong> Influenza vaccinations that are reasonable and necessary for the prevention of illness; and<\/p>\n\n\n\n (5)<\/strong> COVID\u201319 vaccinations that are reasonable and necessary for the prevention of illness.<\/p>\n\n\n\n (f)<\/strong> Orthopedic shoes<\/em><\/strong> or other supportive devices for the feet, except when<\/em> shoes are integral parts of leg braces.<\/p>\n\n\n\n (g)<\/strong> Custodial care, except as necessary<\/em><\/strong> for the palliation or management of terminal illness, as provided in part 418<\/a> of this chapter. (Custodial care is any care that does not meet the requirements for coverage as SNF<\/a> care as set forth in \u00a7\u00a7 409.31<\/a> through 409.35<\/a> of this chapter.)<\/p>\n\n\n\n (h)<\/strong> Cosmetic surgery and related services,<\/em><\/strong> except as required for the prompt repair of accidental injury or to improve the functioning of a malformed body member.<\/p>\n\n\n\n (i)<\/strong> Dental services<\/em><\/strong>\u2014(1) Basic rule. Dental services<\/em> in connection with the care, treatment, filling, removal, or replacement of teeth, or structures directly supporting the teeth.<\/p>\n\n\n\n (2)<\/strong> Exception. Except f<\/em><\/strong>or inpatient<\/a> hospital<\/a> services in connection with such dental procedures when hospitalization is required because of\u2014<\/p>\n\n\n\n (i)<\/strong> The individual’s underlying medical condition and clinical status; or<\/p>\n\n\n\n (ii)<\/strong> The severity of the dental procedures. 577<\/p>\n\n\n\n 577 Before July 1981, inpatient<\/a> hospital<\/a> care in connection with dental procedures was covered only when required by the patient<\/a>‘s underlying medical condition and clinical status.<\/p>\n\n\n\n (3)<\/strong> Inapplicability.<\/em><\/strong><\/p>\n\n\n\n (i)<\/strong> Dental services that are inextricably linked to, and substantially related and integral to the clinical success of, a certain covered medical service are not excluded; payment<\/a> may be made under Medicare Parts A and B for services furnished in the inpatient<\/a> or outpatient setting. Such services include, but are not limited to:<\/p>\n\n\n\n (A)<\/strong> Dental or oral examination performed as part of a comprehensive workup in either the inpatient<\/a> or outpatient setting prior to Medicare-covered organ transplant, cardiac valve replacement, or valvuloplasty procedures; and, medically necessary diagnostic and treatment services to eliminate an oral or dental infection prior to, or contemporaneously with, the organ transplant, cardiac valve replacement, or valvuloplasty procedure.<\/p>\n\n\n\n (B)<\/strong> The reconstruction of a dental ridge performed as a result of and at the same time as the surgical removal of a tumor.<\/p>\n\n\n\n (C)<\/strong> The stabilization or immobilization of teeth in connection with the reduction of a jaw fracture, and dental splints only when used in conjunction with covered treatment of a covered medical condition such as dislocated jaw joints.<\/p>\n\n\n\n (D)<\/strong> The extraction of teeth to prepare the jaw for radiation treatment of neoplastic disease.<\/p>\n\n\n\n (ii)<\/strong> Ancillary services and supplies furnished incident to covered dental services are not excluded, and Medicare payment<\/a> may be made under Part A or Part B, as applicable, whether the service is performed in the inpatient<\/a> or outpatient setting, including, but not limited to the administration of anesthesia, diagnostic x-rays, use of operating room, and other related procedures.<\/p>\n\n\n\n (j)<\/strong> Personal comfort services, except<\/em><\/strong> as necessary for the palliation or management of terminal illness as provided in part 418<\/a> of this chapter. The use of a television set or a telephone are examples of personal comfort<\/em> services.<\/p>\n\n\n\n (k)<\/strong> Any services that are not reasonable and necessary<\/em><\/strong> for one of the following purposes:<\/p>\n\n\n\n (1)<\/strong> For the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.<\/p>\n\n\n\n (2)<\/strong> In the case of hospice services, for the palliation or management of terminal illness, as provided in part 418<\/a> of this chapter.<\/p>\n\n\n\n (3)<\/strong> In the case of pneumococcal vaccine for the prevention of illness.<\/p>\n\n\n\n (4)<\/strong> In the case of the patient<\/a> outcome assessment program established under section 1875(c) of the Act<\/a>, for carrying out the purpose of that section.<\/p>\n\n\n\n (5)<\/strong> In the case of hepatitis B vaccine, for the prevention of illness for those individuals at high or intermediate risk of contracting hepatitis B. (Section 410.63(a)<\/a> of this chapter sets forth criteria for identifying those individuals.)<\/p>\n\n\n\n (6)<\/strong> In the case of screening mammography, for the purpose of early detection of breast cancer subject to the conditions and limitations specified in \u00a7 410.34<\/a> of this chapter.<\/p>\n\n\n\n (7)<\/strong> In the case of colorectal cancer screening tests, for the purpose of early detection of colorectal cancer subject to the conditions and limitations specified in \u00a7 410.37<\/a> of this chapter.<\/p>\n\n\n\n (8)<\/strong> In the case of screening pelvic examinations, for the purpose of early detection of cervical or vaginal cancer subject to the conditions and limitations specified in \u00a7 410.56<\/a> of this chapter.<\/p>\n\n\n\n (9)<\/strong> In the case of prostate cancer screening tests, for the purpose of early detection of prostate cancer, subject to the conditions and limitations specified in \u00a7 410.39<\/a> of this chapter.<\/p>\n\n\n\n (10)<\/strong> In the case of screening exams for glaucoma, for the purpose of early detection of glaucoma, subject to the conditions and limitations specified in \u00a7 410.23<\/a> of this chapter.<\/p>\n\n\n\n (11)<\/strong> In the case of initial preventive physical examinations, with the goal of health promotion and disease prevention, subject to the conditions and limitations specified in \u00a7 410.16<\/a> of this chapter.<\/p>\n\n\n\n (12)<\/strong> In the case of ultrasound screening for abdominal aortic aneurysms, with the goal of early detection of abdominal aortic aneurysms, subject to the conditions and limitation specified in \u00a7 410.19<\/a> of this chapter.<\/p>\n\n\n\n (13)<\/strong> In the case of cardiovascular disease screening tests for the early detection of cardiovascular disease or abnormalities associated with an elevated risk for that disease, subject to the conditions specified in \u00a7 410.17<\/a> of this chapter.<\/p>\n\n\n\n (14)<\/strong> In the case of diabetes screening tests furnished to an individual at risk for diabetes for the purpose of the early detection of that disease, subject to the conditions specified in \u00a7 410.18<\/a> of this chapter.<\/p>\n\n\n\n (15)<\/strong> In the case of additional preventive services not otherwise described in this title<\/a>, subject to the conditions and limitation specified in \u00a7 410.64<\/a> of this chapter.<\/p>\n\n\n\n (16)<\/strong> In the case of an annual wellness visit providing a personalized prevention plan, subject to the conditions and limitations specified in \u00a7 410.15<\/a> of this subpart.<\/p>\n\n\n\n (l)<\/strong> Foot care<\/em><\/strong>\u2014(1) Basic rule.<\/em> Except as provided in paragraph (l)(2)<\/a> of this section, any services furnished in connection with the following:<\/p>\n\n\n\n (i)<\/strong> Routine foot care,<\/em><\/strong> such as the cutting or removal of corns, or calluses, the trimming of nails, routine hygienic care (preventive maintenance care ordinarily within the realm of self care), and any service performed in the absence of localized illness, injury, or symptoms involving the feet.<\/p>\n\n\n\n (ii)<\/strong> The evaluation or treatment of subluxations of the feet<\/em><\/strong> regardless of underlying pathology. (Subluxations are structural misalignments of the joints, other than fractures or complete dislocations, that require treatment only by nonsurgical methods.<\/p>\n\n\n\n (iii)<\/strong> The evaluation or treatment of flattened arches<\/em><\/strong> (including the prescription of supportive devices) regardless of the underlying pathology.<\/p>\n\n\n\n (2)<\/strong> Exceptions.<\/em><\/strong><\/p>\n\n\n\n (i)<\/strong> Treatment of warts is not excluded.<\/p>\n\n\n\n (ii)<\/strong> Treatment of mycotic toenails may be covered if it is furnished no more often than every 60 days or the billing physician<\/a> documents the need for more frequent treatment.<\/p>\n\n\n\n (iii)<\/strong> The services listed in paragraph (l)(1) of this section are not excluded if they are furnished\u2014<\/p>\n\n\n\n (A)<\/strong> As an incident to, at the same time as, or as a necessary integral part of a primary covered procedure performed on the foot; or<\/p>\n\n\n\n (B)<\/strong> As initial diagnostic services (regardless of the resulting diagnosis) in connection with a specific symptom or complaint that might arise from a condition whose treatment would be covered.<\/p>\n\n\n\n (m)<\/strong> Services to hospital patients<\/em><\/strong>\u2014(1) Basic rule.<\/em> Except as provided in paragraph (m)(3)<\/a> of this section, any service furnished to an inpatient<\/a> of a hospital<\/a> or to a hospital<\/a> outpatient (as defined in \u00a7 410.2<\/a> of this chapter) during an encounter (as defined in \u00a7 410.2<\/a> of this chapter) by an entity<\/a> other than the hospital<\/a> unless the hospital<\/a> has an arrangement (as defined in \u00a7 409.3<\/a> of this chapter) with that entity<\/a> to furnish that particular service to the hospital<\/a>‘s patients. As used in this paragraph (m)(1), the term \u201chospital\u201d includes a CAH.<\/p>\n\n\n\n (2)<\/strong> Scope of exclusion.<\/em><\/strong> Services subject to exclusion from coverage under the provisions of this paragraph (m) include, but are not limited to, clinical laboratory services; pacemakers and other prostheses and prosthetic devices (other than dental) that replace all or part of an internal body organ (for example, intraocular lenses); artificial limbs, knees, and hips; equipment<\/a> and supplies covered under the prosthetic device benefits; and services incident to a physician<\/a> service.<\/p>\n\n\n\n (3)<\/strong> Exceptions.<\/em><\/strong> The following services are not excluded from coverage:<\/p>\n\n\n\n (i)<\/strong> Physicians’ services that meet the criteria of \u00a7 415.102(a)<\/a> of this chapter for payment<\/a> on a reasonable charge or fee schedule basis.<\/p>\n\n\n\n (ii)<\/strong> Physician assistant<\/a> services, as defined in section 1861(s)(2)(K)(i) of the Act<\/a>, that are furnished after December 31, 1990.<\/p>\n\n\n\n (iii)<\/strong> Nurse practitioner<\/a> and clinical nurse specialist services, as defined in section 1861(s)(2)(K)(ii) of the Act<\/a>.<\/p>\n\n\n\n (iv)<\/strong> Certified nurse-midwife services, as defined in section 1861(ff) of the Act<\/a>, that are furnished after December 31, 1990.<\/p>\n\n\n\n (v)<\/strong> Qualified psychologist services, as defined in section 1861(ii) of the Act<\/a>, that are furnished after December 31, 1990.<\/p>\n\n\n\n (vi)<\/strong> Services of an anesthetist, as defined in \u00a7 410.69<\/a> of this chapter.<\/p>\n\n\n\n (n)<\/strong> Certain services of an assistant-at-surgery.<\/em><\/strong><\/p>\n\n\n\n (1)<\/strong> Services of an assistant-at-surgery in a cataract operation (including subsequent insertion of an intraocular lens) unless, before the surgery is performed, the appropriate QIO<\/a> or a carrier has approved the use of such an assistant in the surgical procedure based on the existence of a complicating medical condition.<\/p>\n\n\n\n (2)<\/strong> Services on an assistant-at-surgery in a surgical procedure (or class of surgical procedures) for which assistants-at-surgery on average are used in fewer than 5 percent of such procedures nationally.<\/p>\n\n\n\n (o)<\/strong> Experimental or investigational devices, except for certain devices.<\/p>\n\n\n\n (1)<\/strong> Categorized by the FDA<\/a> as a Category B (Nonexperimental\/investigational) device as defined in \u00a7 405.201(b)<\/a> of the chapter; and<\/p>\n\n\n\n (2)<\/strong> Furnished in accordance with the coverage requirements in \u00a7 405.211(b)<\/a>.<\/p>\n\n\n\n (p)<\/strong> Services furnished to SNF residents<\/em><\/strong>\u2014(1) Basic rule.<\/em> Except as provided in