or the absence of helper) may be performed in a freestanding facility, back-up for significant medical problems is performed by a back-up hospital which must be capable of providing the necessary nephrological, medical and surgical expertise, and the appropriate equipment and personnel to care for the patient in the event of his hospitalization. 5. Acute dialysis. Dialysis given to patients on an intensive care, inpatient basis. Acute dialysis may be given to patients with ESRD during periods of acute illness (acute, backup dialysis); it may be given to patients without ESRD who require dialysis for certain conditions, such as, acute renal failure and certain drug ingestions. 6. Self-dialysis. Regular maintenance dialysis performed by a trained patient at home or within an outpatient facility. In the case of home dialysis, the patient performs dialysis at home with the assistance of a trained partner. In the case of "selfcare" dialysis in an outpatient facility, the patient performs dialysis in a facility removed from the home with the assistance of a trained partner or a health professional. In both cases, professional supervision and performance of the dialysis is limited. 7. Limited care dialysis. Regular maintenance dialysis on an outpatient basis in a facility where the actual dialysis procedure is performed by health professionals. 8. Self-dialysis training. The education or training of a patient to permit the patient to perform dialysis on himself (herself). 9. Self-dialysis training program. A program which assesses a patient's ability to learn to perform dialysis. Such a program includes an assessment of the patient's home and family conditions to determine if the patient can perform self-dialysis in the home. If a patient is judged educable in selfdialysis, such a program would also train the patient to perform self-dialysis. 10. Organ procurement. The identification of a prospective donor and the surgical removal of a donor kidney. 11. Organ preservation. The maintenance of a kidney after it has been removed from the donor and until it has been transplanted into a recipient. Organ preservation is an integral part of kidney transplantation and may be accomplished by special solutions and cooling of the kidney, or by perfusion of the kidney using special equipment. 12. Tissue typing and immunology testing. Laboratory procedures used to determine the degree of compatibility between a donor organ and a potential recipient of a kidney transplant. They include: (1) Identification of tissue "types" (HLA); (2) performance of a cross match for cytotoxic antibodies; and (3) certain specialized tests of immunologic reactions such as mixed lymphocyte cultures and cell mediated lympholysis. 13. Living related donor transplantation. A transplant where the organ is donated and removed from a living, blood relative of the patient and transplanted into the patient. Nonrelated living donor transplantation is currently not practiced in this country. 14. Cadaver donor transplantation. Transplantation where the donated organ is taken from an individual who has been pronounced dead according to medical criteria. The organ is removed from the donor and transplanted into the recipient. 15. Cannula. A surgically prepared, exposed connection between an artery and a vein. The exposed connection between artery and vein is made with a special type of plastic tubing. 16. Fistula. A surgically prepared unexposed connection made directly between an artery and vein to permit repeated and ready access to the blood stream. Dialysis access to the blood stream is obtained with large hollow needles; creation of a fistula is an alternative to surgical insertion of a cannula. 17. "Directly provides" or "provides directly". This term means that the hospital (or facility) provides the service through its own staff and employees, or through individuals who are under contract with the facility to provide such services. 18. "Under arrangement". This term means that the hospital (or facility) arranges for another facility to provide the services but assumes responsibility for such services and bills the Medicare program for the services. Pursuant to section 1861(w) of the Act (42 U.S.C. 1395x(w)) receipt of payment for such covered services on behalf of an entitled individual discharges the liability of such individual or any other person to pay for such services. 19. "By an agreement" or "has an agreement". This term means that the hospital (or facility) has an agreement whereby another facility undertakes to provide services to patients who become the patients of the other facility (for those services provided), and the other facility bills the Medicare program for their services furnished. 20. "Provides on the premises". This term means that the hospital provides the service on its own premises or on premises that are contiguous with or immediately in proximity to its own. 21. Home dialysis support services. The services of professional care, consultation, provision of supplies, back-up, and equipment repair that home dialysis patients require. 22. Recipient registry. A prospective listing of patients (including certain medical data on these patients) who are awaiting a cadaver donor transplant. [40 FR 17747, Apr. 22, 1975. Redesignated at 42 FR 52826, Sept. 30, 1977] Subpart C-Exclusions, Recovery of Overpayment, Liability of a Certifying Officer and Suspension of Payment AUTHORITY: Secs. 1102, 1842, 1862, 1870, 1871, 49 Stat. 647, as amended, 79 Stat. 309, 79 Stat. 325, 79 Stat. 331; 42 U.S.C. 1302, 1395 et seq. SOURCE: 31 FR 13534, Oct. 20, 1966, unless otherwise noted. Redesignated at 42 FR 52826, Sept. 30, 1977. § 405.301 Scope of subpart. Sections 405.310 to 405.320 describe certain exclusions from coverage applicable to hospital insurance benefits (Part A of title XVIII) and supplementary medical insurance benefits (Part B of title XVIII). The exclusions in this subpart are applicable in addition to any other conditions and limitations in this Part 405 and in title XVIII of the Act. Sections 405.330 to 405.332 relate to payments for expenses for certain items or services otherwise excluded from coverage. Sections 405.350 to 405.359 relate to the adjustment or recovery of an incorrect payment, or a payment made under section 1814(e) of Part A of title XVIII of the Act. Sections 405.370 to 95.373 relate to the suspension of payment to a provider of services or other supplier of services where there is evidence that such provider or supplier has been or may have been overpaid. [40 FR 1023, Jan. 6, 1975. Redesignated at 42 FR 52826, Sept. 30, 1977] § 405.310 Types of expenses not covered. Notwithstanding any other provisions of this Part 405, no payment may be made for any expenses incurred for the following items or services: (a) Routine physical checkups-such as examinations performed not for the purpose of treatment or diagnosis of a specific illness, symptom, complaint, or injury, or examinations required by third parties, such as insurance companies; (b) Eyeglasses or contact lenseshowever, payment may be made for post-surgical lenses customarily used during convalescence from eye surgery in which the lens of the eye was removed, or prosthetic lenses for patients who do not have the organic lens of the eye; e.g., due to cataract surgery or a congenital absence of the lens; (c) Eye examinations 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 of the eyes, whether performed by an ophthalmologist or other physician, or by an optometrist, and without regard to the reason for the performance of the refractive procedure (including all refractive procedures performed in connection with the diagnosis or treatment of an eye disease or injury, and prescribing or providing prosthetic lenses): Except that, during the period July 1, 1966, through January 1, 1968, refractive procedures performed by a physician as part of an eye examination performed in connection with the diagnosis or treatment of an eye disease (such as glaucoma or cataracts) or injury, and refractive procedures performed by any individual in connection with prescribing or providing prosthetic lenses, are covered; (d) Hearing aids or examinations for the purpose of prescribing, fitting, or changing hearing aids; (e) Immunizations-no payment is made for vaccinations or innoculations unless 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; (f) Orthopedic shoes or other supportive devices for the feet-except when shoes are integral parts of leg braces; (g) Custodial care (in the case of extended care services, any care which does not meet the definition of extended care in §§ 405.126-405.128); (h) Cosmetic surgery, or in connection therewith, except as required for the prompt repair of accidental injury or for the improvement of the functioning of a malformed body member; (i) Dental services in connection with the care, treatment, filling, removal, or replacement of teeth, or structures directly supporting the teeth, except that payment may be made under Part A of title XVIII for inpatient hospital services in connection with such dental procedures when the individual's underlying medical condition and clinical status require hospitalization; (j) Personal comfort items and services (for example a television set, or telephone service, etc.); (k) Which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member (thus, payment could not be made for the rental of a special hospital bed to be used by an individual in his home if it was not a reasonable and necessary part of the individual's treatment); (1)(1) Any services, regardless of the individual performing them, furnished in connection with: (i) Routine foot care, including the cutting or removal of corns, warts, or calluses, the trimming of nails, routine hygienic care (preventive maintenance care of the type ordinarily within the realm of self-care), and any services performed in the absence of localized illness, injury, or symptoms involving the feet; (ii) The treatment, including evaluations, of subluxations of the feet (structural misalignments, other than fractures or complete dislocations, of the joints of the feet which require treatment only by nonsurgical methods, regardless of underlying pathology); (iii) The treatment (including evaluations and the prescription of supportive devices) of the local condition of flattened arches regardless of the underlying pathology: (2) Except that any such services which are furnished as an incident to, at the same time as, and as a necessary integral part of a primary covered procedure performed on the foot; or as initial diagnostic services in connection with a specific symptom or complaint which might arise from a condition whose treatment would be cov ered, regardless of the resulting diagnosis, are covered. (m) Post-hospital extended care services furnished before 1967; or (n) Post-hospital extended care services furnished after 1966, or post-hospital home health services furnished at any time, if the hospital discharge necessary to qualify such services for payment under Part A of title XVIII occurred (1) In the case of an individual entitled to hospital insurance benefits under § 405.102, before July 1, 1966, or if later, before the first month in which he attained age 65; and (2) In the case of an individual entitled to hospital insurance benefits under §§ 405.104 or 405.105, when the individual was not entitled to such benefits. [31 FR 13534, Oct. 20, 1966, as amended at 32 FR 1172, Feb. 2, 1967; 33 FR 9767, July 6, 1968; 36 FR 10850, June 4, 1971; 39 FR 28625, Aug. 9, 1974; 40 FR 1023, Jan. 6, 1975; 40 FR 24360, June 6, 1975. Redesignated at 42 FR 52826, Sept. 30, 1977] § 405.311 Nonreimbursable expenses; individual has no legal obligation to pay for items or services. Payment may not be made under title XVIII of the Act for expenses incurred for items or services for which the individual who is furnished such items or services has no legal obligation to pay, and which no other person (by reason of the individual's mernbership in a prepayment plan or otherwise) has a legal obligation to provide or pay for. For example, no payment may be made for items or services, such as a chest X-ray, that are rendered free of charge by health organizations without regard for the individual's ability to pay. This exclusion does not prevent payment for items or services furnished by a group health prepayment plan to a member of the plan. Neither does it apply to items or services paid for by a governmentai entity (with respect to such items or services, see § 405.312). § 405.312 Nonreimbursable expenses; items or services paid for by governmental entity. Payment may not be made under title XVIII of the Act for expenses in curred for items or services that are paid for directly or indirectly by a governmental entity, except: (a) Payment may be made for items or services furnished under a health insurance plan established for employees of the governmental entity. (b) Payment may be made for items or services furnished an individual under a program based on one of the titles of the Social Security Act. (c) Payment may be made for items and services furnished an individual in or by a participating hospital operated by a State or local governmental entity, where such hospital is a general or special hospital serving the general community, including a mental or tuberculosis hospital or a hospital for treatment of infectious disease. (d) Payment may be made for items and services paid for by a State or local governmental entity and furnished an individual as a means of controlling infectious diseases or because of the individual's medical indigency, whether or not such services are furnished in a hospital. (e) Payment may be made to a participating Federal hospital for items and services which it furnishes to the general public as a community institution or agency, but not for any items 'r services which it is required to furnish at public expense under a law of, or contract with, the United States. (f) Payment may be made for items and services furnished by a public or private health facility which receives United States Government funds under a Federal program which provides support to facilities which furnish health care services (other than a Federal provider of services): Provided, The facility receiving such Federal support customarily seeks reimbursement for items and services not covered under title XVIII of the Social Security Act, from all resources available for the health care of its patients, e.g., private insurance, patients' cash resources, etc. Payments that are made for such items and services covered under supplementary medical insurance shall be subject to the individual's deductible and shall not exceed 80 percent of charges related to rea charges imposed by immediate relatives or members of beneficiaries' household. Payment on a reasonable charge basis may not be made under Part B of title XVIII of the Act (see Subpart B of this part) for expenses incurred by an individual, if such expenses constitute charges (including the professional component of services of hospitalbased physicians—see § 405.480 et seq.) imposed by physicians or other persons who are immediate relatives of such individual or members of his household, to the extent that such charges exceed the actual costs incurred by such physicians or other persons in procuring items furnished such individual. (a) Any person who has any of the following degrees of relationship to any other person is an "immediate relative": (1) Husband and wife; (2) natural parent, child, and sibling; (3) adopted child and adoptive parent; (4) stepparent, stepchild, stepbrother, and stepsister; (5) father-in-law, mother-inlaw, son-in-law, daughter-in-law, brother-in-law, and sister-in-law; (6) grandparent and grandchild. (b) The term "members of his household" means those persons sharing a common abode as part of a single family unit, including those related by blood, marriage, or adoption as well as domestic employees and others who live together as part of this family unit, but not including a mere roomer or boarder. (c) The exclusion refers to the person imposing the charges, who might not be the person rendering the services. For example, where the charges are imposed by a: (1) Physician or other practitioner, the exclusion would apply to charges imposed for personal services, if the physician or other practitioner has the excluded relationship to the beneficiary. (2) Partnership, the exclusion would apply only if all of the partners have the excluded relationship to the beneficiary. (3) Corporation, the exclusion would not apply, regardless of the beneficiary's relationship to the directors, offi Items or services furnished by excluded provider or other person. (a) Definitions. As used in this section and in § 405.614: (1) The term "provider of services" or "provider" means a hospital, skilled nursing facility, home health agency, or provider of outpatient physical therapy services (see Subparts J, K, L, and Q of this part), and (2) The term "person" means a physician or other supplier of services, other than a provider of services. (b) General. Payment may not be made under title XVIII of the Act for expenses incurred for iteras or services which are furnished by a provider or other person where the Health Care Financing Administration determines under this section that such provider or other person: (1) Has knowingly and willfully made, or caused to be made, any false statement or representation of a material fact for use in an application or request for payment under title XVIII or for use in determining the right to a payment under title XVIII; or (2) Has submitted or caused to be submitted (except in the case of a provider of services), bills or requests for payment under title XVIII containing charges (or in applicable cases, requests for payment of costs to such person) for items or services rendered which the Health Care Financing Administration finds, with the concurrence of the appropriate program review team appointed pursuant to § 405.315b, to be substantially in excess of such person's customary charges (or in applicable cases, substantially in excess of such person's costs) for such items or services, unless the Health Care Financing Administration finds there is good cause for such bills or requests containing such charges (or in |