[Code of Federal Regulations] [Title 42, Volume 2] [Revised as of October 1, 2007] From the U.S. Government Printing Office via GPO Access [CITE: 42CFR411.15] [Page 390-394] TITLE 42--PUBLIC HEALTH HUMAN SERVICES PART 411_EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT-- Table of Contents Subpart A_General Exclusions and Exclusion of Particular Services Sec. 411.15 Particular services excluded from coverage. The following services are excluded from coverage: (a) Routine physical checkups such as: (1) 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, initial preventive physical examinations, or ultrasound screening for abdominal aortic aneurysms that meet the criteria specified in paragraphs (k)(6) through (k)(12) of this section. (2) Examinations required by insurance companies, business establishments, government agencies, or other third parties. (b) Eyeglasses or contact lenses, except for: (1) Post-surgical prosthetic lenses customarily used during convalescence for eye surgery in which the lens of the eye was removed (e.g., cataract surgery); (2) Prosthetic lenses for patients who lack the lens of the eye because of congenital absence or surgical removal; and (3) One pair of conventional eyeglasses or conventional contact lenses furnished after each cataract surgery during which an intraocular lens is inserted. (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, 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. (d) Hearing aids or examination for the purpose of prescribing, fitting, or changing hearing aids. (e) Immunizations, except for-- (1) 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; (2) Pneumococcal vaccinations that are reasonable and necessary for the prevention of illness; [[Page 391]] (3) Hepatitis B vaccinations that are reasonable and necessary for the prevention of illness for those individuals, as defined in Sec. 410.63(a) of this chapter, who are at high or intermediate risk of contracting hepatitis B; and (4) Influenza vaccinations that are reasonable and necessary for the prevention of illness. (f) Orthopedic shoes or other supportive devices for the feet, except when shoes are integral parts of leg braces. (g) Custodial care, except as necessary for the palliation or management of terminal illness, as provided in part 418 of this chapter. (Custodial care is any care that does not meet the requirements for coverage as SNF care as set forth in Sec. Sec. 409.31 through 409.35 of this chapter.) (h) Cosmetic surgery and related services, except as required for the prompt repair of accidental injury or to improve 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 for inpatient hospital services in connection with such dental procedures when hospitalization is required because of-- (1) The individual's underlying medical condition and clinical status; or (2) The severity of the dental procedures. \1\ --------------------------------------------------------------------------- \1\ Before July 1981, inpatient hospital care in connection with dental procedures was covered only when required by the patient's underlying medical condition and clinical status. --------------------------------------------------------------------------- (j) Personal comfort services, except as necessary for the palliation or management of terminal illness as provided in part 418 of this chapter. The use of a television set or a telephone are examples of personal comfort services. (k) Any services that are not reasonable and necessary for one of the following purposes: (1) For the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. (2) In the case of hospice services, for the palliation or management of terminal illness, as provided in part 418 of this chapter. (3) In the case of pneumococcal vaccine for the prevention of illness. (4) In the case of the patient outcome assessment program established under section 1875(c) of the Act, for carrying out the purpose of that section. (5) 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) of this chapter sets forth criteria for identifying those individuals.) (6) In the case of screening mammography, for the purpose of early detection of breast cancer subject to the conditions and limitations specified in Sec. 410.34 of this chapter. (7) 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 Sec. 410.37 of this chapter. (8) 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 Sec. 410.56 of this chapter. (9) 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 Sec. 410.39 of this chapter. (10) In the case of screening exams for glaucoma, for the purpose of early detection of glaucoma, subject to the conditions and limitations specified in Sec. 410.23 of this chapter. (11) 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 Sec. 410.16 of this chapter. (12) 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 Sec. 410.19 of this chapter. (l) Foot care--(1) Basic rule. Except as provided in paragraph (l)(2) of this section, any services furnished in connection with the following: (i) Routine foot care, such as the cutting or removal of corns, or calluses, the trimming of nails, routine hygienic [[Page 392]] 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. (ii) The evaluation or treatment of subluxations of the feet regardless of underlying pathology. (Subluxations are structural misalignments of the joints, other than fractures or complete dislocations, that require treatment only by nonsurgical methods. (iii) The evaluation or treatment of flattened arches (including the prescription of supportive devices) regardless of the underlying pathology. (2) Exceptions. (i) Treatment of warts is not excluded. (ii) Treatment of mycotic toenails may be covered if it is furnished no more often than every 60 days or the billing physician documents the need for more frequent treatment. (iii) The services listed in paragraph (l)(1) of this section are not excluded if they are furnished-- (A) 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 (B) 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. (m) Services to hospital patients--(1) Basic rule. Except as provided in paragraph (m)(3) of this section, any service furnished to an inpatient of a hospital or to a hospital outpatient (as defined in Sec. 410.2 of this chapter) during an encounter (as defined in Sec. 410.2 of this chapter) by an entity other than the hospital unless the hospital has an arrangement (as defined in Sec. 409.3 of this chapter) with that entity to furnish that particular service to the hospital's patients. As used in this paragraph (m)(1), the term ``hospital'' includes a CAH. (2) Scope of exclusion. 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 and supplies covered under the prosthetic device benefits; and services incident to a physician service. (3) Exceptions. The following services are not excluded from coverage: (i) Physicians' services that meet the criteria of Sec. 415.102(a) of this chapter for payment on a reasonable charge or fee schedule basis. (ii) Physician assistant services, as defined in section 1861(s)(2)(K)(i) of the Act, that are furnished after December 31, 1990. (iii) Nurse practitioner and clinical nurse specialist services, as defined in section 1861(s)(2)(K)(ii) of the Act. (iv) Certified nurse-midwife services, as defined in section 1861(ff) of the Act, that are furnished after December 31, 1990. (v) Qualified psychologist services, as defined in section 1861(ii) of the Act, that are furnished after December 31, 1990. (vi) Services of an anesthetist, as defined in Sec. 410.69 of this chapter. (n) Certain services of an assistant-at-surgery. (1) 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 or a carrier has approved the use of such an assistant in the surgical procedure based on the existence of a complicating medical condition. (2) 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. (o) Experimental or investigational devices, except for certain devices. (1) Categorized by the FDA as a non-experimental/investigational (Category B) device defined in Sec. 405.201(b) of this chapter; and (2) Furnished in accordance with the FDA-approved protocols governing clinical trials. (p) Services furnished to SNF residents--(1) Basic rule. Except as provided in paragraph (p)(2) of this section, any service furnished to a resident of an SNF during a covered Part A stay by an entity other than the SNF, unless [[Page 393]] the SNF has an arrangement (as defined in Sec. 409.3 of this chapter) with that entity to furnish that particular service to the SNF's residents. Services subject to exclusion under this paragraph include, but are not limited to-- (i) Any physical, occupational, or speech-language therapy services, regardless of whether the services are furnished by (or under the supervision of) a physician or other health care professional, and regardless of whether the resident who receives the services is in a covered Part A stay; and (ii) Services furnished as an incident to the professional services of a physician or other health care professional specified in paragraph (p)(2) of this section. (2) Exceptions. The following services are not excluded from coverage, provided that the claim for payment includes the SNF's Medicare provider number in accordance with Sec. 424.32(a)(5) of this chapter: (i) Physicians' services that meet the criteria of Sec. 415.102(a) of this chapter for payment on a fee schedule basis. (ii) Services performed under a physician's supervision by a physician assistant who meets the applicable definition in section 1861(aa)(5) of the Act. (iii) Services performed by a nurse practitioner or clinical nurse specialist who meets the applicable definition in section 1861(aa)(5) of the Act and is working in collaboration (as defined in section 1861(aa)(6) of the Act) with a physician. (iv) Services performed by a certified nurse-midwife, as defined in section 1861(gg) of the Act. (v) Services performed by a qualified psychologist, as defined in section 1861(ii) of the Act. (vi) Services performed by a certified registered nurse anesthetist, as defined in section 1861(bb) of the Act. (vii) Dialysis services and supplies, as defined in section 1861(s)(2)(F) of the Act, and those ambulance services that are furnished in conjunction with them. (viii) Erythropoietin (EPO) for dialysis patients, as defined in section 1861(s)(2)(O) of the Act. (ix) Hospice care, as defined in section 1861(dd) of the Act. (x) An ambulance trip that initially conveys an individual to the SNF to be admitted as a resident, or that conveys an individual from the SNF in connection with one of the circumstances specified in paragraphs (p)(3)(i) through (p)(3)(iv) of this section as ending the individual's status as an SNF resident. (xi) The transportation costs of electrocardiogram equipment (HCPCS code R0076), but only with respect to those electrocardiogram test services furnished during 1998. (xii) Those chemotherapy items identified, as of July 1, 1999, by HCPCS codes J9000-J9020; J9040-J9151; J9170-J9185; J9200-J9201; J9206- J9208; J9211; J9230-J9245; and J9265-J9600; and, as of January 1, 2004, by HCPCS codes A9522, A9523, A9533, and A9534. (xiii) Those chemotherapy administration services identified, as of July 1, 1999, by HCPCS codes 36260-36262; 36489; 36530-36535; 36640; 36823; and 96405-96542. (xiv) Those radioisotope services identified, as of July 1, 1999, by HCPCS codes 79030-79440. (xv) Those customized prosthetic devices (including artificial limbs and their components) identified, as of July 1, 1999, by HCPCS codes L5050-L5340; L5500-L5611; L5613-L5986; L5988; L6050-L6370; L6400-6880; L6920-L7274; and L7362-L7366, which are delivered for a resident's use during a stay in the SNF and intended to be used by the resident after discharge from the SNF. (3) SNF resident defined. For purposes of this paragraph, a beneficiary who is admitted to a Medicare-participating SNF is considered to be a resident of the SNF for the duration of the beneficiary's covered Part A stay. In addition, for purposes of the services described in paragraph (p)(1)(i) of this section, a beneficiary who is admitted to a Medicare-participating SNF is considered to be a resident of the SNF regardless of whether the beneficiary is in a covered Part A stay. Whenever the beneficiary leaves the facility, the beneficiary's status as an SNF resident for purposes of this paragraph (along with the SNF's responsibility to furnish or make arrangements for the services described in paragraph (p)(1) of this section) ends when one of the following events occurs-- [[Page 394]] (i) The beneficiary is admitted as an inpatient to a Medicare- participating hospital or CAH, or as a resident to another SNF; (ii) The beneficiary receives services from a Medicare-participating home health agency under a plan of care; (iii) The beneficiary receives outpatient services from a Medicare- participating hospital or CAH (but only with respect to those services that are beyond the general scope of SNF comprehensive care plans, as required under Sec. 483.20 of this chapter); or (iv) The beneficiary is formally discharged (or otherwise departs) from the SNF, unless the beneficiary is readmitted (or returns) to that or another SNF by midnight of the day of departure. (q) Assisted suicide. Any health care service used for the purpose of causing, or assisting to cause, the death of any individual. This does not pertain to the withholding or withdrawing of medical treatment or care, nutrition or hydration or to the provision of a service for the purpose of alleviating pain or discomfort, even if the use may increase the risk of death, so long as the service is not furnished for the specific purpose of causing death. (r) A home health service (including medical supplies described in section 1861(m)(5) of the Act, but excluding durable medical equipment to the extent provided for in such section) as defined in section 1861(m) of the Act furnished to an individual who is under a plan of care of an HHA, unless that HHA has submitted a claim for payment for such services. (s) Unless Sec. 414.404(d) or Sec. 414.408(e)(2) of this subchapter applies, Medicare does not make payment if an item or service that is included in a competitive bidding program (as described in Part 414, Subpart F of this subchapter) is furnished by a supplier other than a contract supplier (as defined in Sec. 414.402 of this subchapter). [54 FR 41734, Oct. 11, 1989; 55 FR 1820, Jan. 19, 1990, as amended at 55 FR 22789, June 4, 1990; 55 FR 31185, Aug. 1, 1990; 57 FR 33897, July 31, 1992; 57 FR 36015, Aug. 12, 1992; 58 FR 30669, May 26, 1993; 59 FR 49834, Sept. 30, 1994; 60 FR 63188, Dec. 8, 1995; 62 FR 46037, Aug. 29, 1997; 62 FR 59101, Oct. 31, 1997; 63 FR 26308, May 12, 1998; 63 FR 35066, June 26, 1998; 64 FR 41682, July 30, 1999; 64 FR 59441, Nov. 2, 1999; 65 FR 18537, Apr. 7, 2000; 65 FR 41211, July 3, 2000; 65 FR 46796, July 31, 2000; 66 FR 32778, June 18, 2001; 66 FR 39600, July 31, 2001; 66 FR 48078, Sept. 17, 2001; 66 FR 55331, Nov. 1, 2001; 66 FR 58786, Nov. 23, 2001; 68 FR 46070, Aug. 4, 2003; 69 FR 66423, Nov. 15, 2004; 70 FR 45055, Aug. 4, 2005; 71 FR 69785, Dec. 1, 2006; 72 FR 18914, Apr. 16, 2007; 72 FR 18084, Apr. 10, 2007]