§ 410.35 42 CFR Ch. IV (10–1–12 Edition)

the last screening mammography was (1) Colorectal cancer screening tests performed. means any of the following procedures furnished to an individual for the pur- [59 FR 49833, Sept. 30, 1994, as amended at 60 FR 14224, Mar. 16, 1995; 60 FR 63176, Dec. 8, pose of early detection of colorectal 1995; 62 FR 59100, Oct. 31, 1997; 63 FR 4596, cancer: Jan. 30, 1998] (i) Screening fecal-occult blood tests. (ii) Screening flexible § 410.35 X-ray therapy and other radi- sigmoidoscopies. ation therapy services: Scope. (iii) In the case of an individual at Medicare Part B pays for X-ray ther- high risk for colorectal cancer, screen- apy and other radiation therapy serv- ing colonoscopies. ices, including radium therapy and ra- (iv) Screening barium enemas. dioactive isotope therapy, and mate- (v) Other tests or procedures estab- rials and the services of technicians ad- lished by a national coverage deter- ministering the treatment. mination, and modifications to tests [51 FR 41339, Nov. 14, 1986. Redesignated at 55 under this paragraph, with such fre- FR 53522, Dec. 31, 1990] quency and payment limits as CMS de- termines appropriate, in consultation § 410.36 Medical supplies, appliances, with appropriate organizations and devices: Scope. (2) Screening fecal-occult blood test (a) Medicare Part B pays for the fol- means— lowing medical supplies, appliances (i) A guaiac-based test for peroxidase and devices: activity, testing two samples from (1) Surgical dressings, and splints, each of three consecutive stools, or, casts, and other devices used for reduc- (ii) Other tests as determined by the tion of fractures and dislocations. Secretary through a national coverage (2) Prosthetic devices, other than determination. dental, that replace all or part of an in- (3) An individual at high risk for ternal body organ, including colostomy colorectal cancer means an individual bags and supplies directly related to with— colostomy care, including— (i) A close relative (sibling, parent, (i) Replacement of prosthetic devices; or child) who has had colorectal cancer and or an adenomatous polyp; (ii) One pair of conventional eye- (ii) A family history of familial ade- glasses or conventional contact lenses nomatous polyposis; furnished after each cataract surgery (iii) A family history of hereditary during which an intraocular lens is in- nonpolyposis colorectal cancer; serted. (iv) A personal history of adenom- (3) Leg, arm, back, and neck braces atous polyps; or and artificial legs, arms, and eyes, in- (v) A personal history of colorectal cluding replacements if required be- cancer; or cause of a change in the individual’s (vi) Inflammatory bowel disease, in- physical condition. cluding Crohn’s Disease, and ulcerative (b) As a requirement for payment, colitis. CMS may determine through carrier (4) Screening barium enema means— instructions, or carriers may deter- (i) A screening double contrast bar- mine, that an item listed in paragraph ium enema of the entire colorectum (a) of this section requires a written (including a physician’s interpretation physician order before delivery of the of the results of the procedure); or item. (ii) In the case of an individual whose [51 FR 41339, Nov. 14, 1986, as amended at 57 attending physician decides that he or FR 36014, Aug. 12, 1992; 57 FR 57688, Dec. 7, she cannot tolerate a screening double 1992] contrast barium enema, a screening single contrast barium enema of the § 410.37 Colorectal cancer screening entire colorectum (including a physi- tests: Conditions for and limitations cian’s interpretation of the results of on coverage. the procedure). (a) Definitions. As used in this sec- (5) An attending physician for purposes tion, the following definitions apply: of this provision is a doctor of medicine

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or osteopathy (as defined in section sigmoidosocopy only after at least 119 1861(r)(1) of the Act) who is fully months have passed following the knowledgeable about the beneficiary’s month in which the last screening medical condition, and who would be colonoscopy was performed. responsible using the results of any ex- (f) Condition for coverage of screening amination performed in the overall colonoscopies. Medicare Part B pays for management of the beneficiary’s spe- a screening colonoscopy if it is per- cific medical problem. formed by a doctor of medicine or oste- (b) Condition for coverage of screening opathy (as defined in section 1861(r)(1) fecal-occult blood tests. Medicare Part B of the Act). pays for a screening fecal-occult blood (g) Limitations on coverage of screening test if it is ordered in writing by the colonoscopies. (1) Effective for services beneficiary’s attending physician. furnished on or after January 1, 1998 (c) Limitations on coverage of screening through June 30, 2001, payment may fecal-occult blood tests. (1) Payment may not be made for a screening not be made for a screening fecal-oc- colonoscopy for an individual who is cult blood test performed for an indi- not at high risk for colorectal cancer vidual under age 50. as described in paragraph (a)(3) of this (2) For an individual 50 years of age section. or over, payment may be made for a (2) Effective for services furnished on screening fecal-occult blood test per- or after July 1, 2001, except as de- formed after at least 11 months have scribed in paragraph (g)(4) of this sec- passed following the month in which tion, payment may be made for a the last screening fecal-occult blood screening colonoscopy performed for an test was performed. individual who is not at high risk for (d) Condition for coverage of flexible colorectal cancer as described in para- sigmoidoscopy screening. Medicare Part graph (a)(3) of this section, after at B pays for a flexible sigmoidoscopy least 119 months have passed following screening service if it is performed by a the month in which the last screening doctor of medicine or osteopathy (as colonoscopy was performed. defined in section 1861(r)(1) of the Act), (3) Payment may be made for a or by a physician assistant, nurse prac- screening colonoscopy performed for an titioner, or clinical nurse specialist (as individual who is at high risk for defined in section 1861(aa)(5) of the Act colorectal cancer as described in para- and §§ 410.74, 410.75, and 410.76) who is graph (a)(3) of this section, after at authorized under State law to perform least 23 months have passed following the examination. the month in which the last screening (e) Limitations on coverage of screening colonoscopy was performed, or, as pro- flexible sigmoidoscopies. (1) Payment vided in paragraphs (h) and (i) of this may not be made for a screening flexi- section, the last screening barium ble sigmoidoscopy performed for an in- enema was performed. dividual under age 50. (4) In the case of an individual who is (2) For an individual 50 years of age not at high risk for colorectal cancer or over, except as described in para- as described in paragraph (a)(3) of this graph (e)(3) of this section, payment section but who has had a screening may be made for screening flexible flexible sigmoidoscopy performed, pay- sigmoidoscopy after at least 47 months ment may be made for a screening have passed following the month in colonoscopy only after at least 47 which the last screening flexible months have passed following the sigmoidoscopy or, as provided in para- month in which the last screening graphs (h) and (i) of this section, the flexible sigmoidoscopy was performed. last screening barium enema was per- (h) Conditions for coverage of screening formed. barium enemas. Medicare Part B pays (3) In the case of an individual who is for a screening barium enema if it is not at high risk for colorectal cancer ordered in writing by the beneficiary’s as described in paragraph (a)(3) of this attending physician. section but who has had a screening (i) Limitations on coverage of screening colonoscopy performed, payment may barium enemas. (1) In the case of an in- be made for a screening flexible dividual age 50 or over who is not at

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high risk of colorectal cancer, payment tion of the specific type of PMD), the may be made for a screening barium length of need, and the physician or enema examination performed after at treating practitioner’s signature and least 47 months have passed following the date the prescription was written. the month in which the last screening Treating practitioner means a physi- barium enema or screening flexible cian assistant, nurse practitioner, or sigmoidoscopy was performed. clinical nurse specialist as those terms (2) In the case of an individual who is are defined in section 1861(aa)(5) of the at high risk for colorectal cancer, pay- Act, who has conducted a face-to-face ment may be made for a screening bar- examination of the beneficiary. ium enema examination performed Supplier means an entity with a valid after at least 23 months have passed Medicare supplier number, including following the month in which the last an entity that furnishes items through screening barium enema or the last the mail. screening colonoscopy was performed. (2) Conditions of payment. Medicare [62 FR 59100, Oct. 31, 1997, as amended at 66 Part B pays for a power mobility de- FR 55329, Nov. 1, 2001; 67 FR 80040, Dec. 31, vice if the physician or treating practi- 2002] tioner, as defined in paragraph (c)(1) of this section meets the following condi- § 410.38 Durable medical equipment: tions: Scope and conditions. (i) Conducts a face-to-face examina- (a) Medicare Part B pays for the rent- tion of the beneficiary for the purpose al or purchase of durable medical of evaluating and treating the bene- equipment, including iron lungs, oxy- ficiary for his or her medical condition gen tents, hospital beds, and wheel- and determining the medical necessity chairs, if the equipment is used in the for the PMD as part of an appropriate patient’s home or in an institution overall treatment plan. that is used as a home. (ii) Writes a prescription, as defined (b) An institution that is used as a in paragraph (c)(1) of this section that home may not be a hospital or a CAH is provided to the beneficiary or sup- or a SNF as defined in sections plier, and is received by the supplier 1861(e)(1), 1861(mm)(1) and 1819(a)(1) of within 45 days after the face-to-face ex- the Act, respectively. amination. (c) Power mobility devices (PMDs)—(1) (iii) Provides supporting documenta- Definitions. For the purposes of this tion, including pertinent parts of the paragraph, the following definitions beneficiary’s medical record (for exam- apply: ple, history, physical examination, di- Physician has the same meaning as in agnostic tests, summary of findings, di- section 1861(r)(1) of the Act. agnoses, treatment plans and/or other Power mobility device means a covered information as may be appropriate) item of durable medical equipment that supports the medical necessity for that is in a class of wheelchairs that the power mobility device, which is re- includes a power wheelchair (a four- ceived by the supplier within 45 days wheeled motorized vehicle whose steer- after the face-to-face examination. ing is operated by an electronic device (3) Exceptions. (i) Beneficiaries dis- or a joystick to control direction and charged from a hospital do not need to turning) or a power-operated vehicle (a receive a separate face-to-face exam- three or four-wheeled motorized scoot- ination as long as the physician or er that is operated by a tiller) that a treating practitioner who performed beneficiary uses in the home. the face-to-face examination of the Prescription means a written order beneficiary in the hospital issues a completed by the physician or treating PMD prescription and supporting docu- practitioner who performed the face- mentation that is received by the sup- to-face examination and that includes plier within 45 days after the date of the beneficiary’s name, the date of the discharge. face-to-face examination, the diagnoses (ii) Accessories for PMDs may be or- and conditions that the PMD is ex- dered by the physician or treating pected to modify, a description of the practitioner without conducting a face- item (for example, a narrative descrip- to-face examination of the beneficiary.

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