CFR-2015-title42-vol2-sec410-33.pdf

in-cluding serial and registration numbers and provide this information to the designated fee-for-service contractor upon request, and notify the contractor of any changes in equipment within 90 days. (5) Maintain a primary business phone under the name of the des-ignated business. The IDTF must have its (i) Primary business phone located at the designated site of the business or within the home office of the mobile IDTF units. (ii) Telephone or toll free telephone numbers available in a local directory and through directory assistance. (6) Have a comprehensive liability in-surance policy of at least $300,000 per location that covers both the place of business and all customers and employ-ees of the IDTF. The policy must be carried by a nonrelative-owned com-pany. Failure to maintain required in-surance at all times will result in rev-ocation of the IDTFs billing privileges retroactive to the date the insurance lapsed. IDTF suppliers are responsible for providing the contact information for the issuing insurance agent and the underwriter. In addition, the IDTF must (i) Ensure that the insurance policy must remain in force at all times and provide coverage of at least $300,000 per incident; and VerDate Sep<11>2014 17:46 Oct 23, 2015 Jkt 235189 PO 00000 Frm 00386 Fmt 8010 Sfmt 8010 Q:\42\42V2.TXT 31lpowell on DSK54DXVN1OFR with $$_JOB377 Centers for Medicare & Medicaid Services, HHS  410.33 (ii) Notify the CMS designated con-tractor in writing of any policy changes or cancellations. (7) Agree not to directly solicit pa-tients, which include, but is not lim-ited to, a prohibition on telephone, computer, or in-person contacts. The IDTF must accept only those patients referred for diagnostic testing by an at-tending physician, who is furnishing a consultation or treating a beneficiary for a specific medical problem and who uses the results in the management of the beneficiarys specific medical prob-lem. Nonphysician practitioners may order tests as set forth in 410.32(a)(3). (8) Answer, document, and maintain documentation of a beneficiarys writ-ten clinical complaint at the physical site of the IDTF (For mobile IDTFs, this documentation would be stored at their home office.) This includes, but is not limited to, the following: (i) The name, address, telephone number, and health insurance claim number of the beneficiary. (ii) The date the complaint was re-ceived; the name of the person receiv-ing the complaint; and a summary of actions taken to resolve the complaint. (iii) If an investigation was not con-ducted, the name of the person making the decision and the reason for the de-cision. (9) Openly post these standards for review by patients and the public. (10) Disclose to the government any person having ownership, financial, or control interest or any other legal in-terest in the supplier at the time of en-rollment or within 30 days of a change. (11) Have its testing equipment cali-brated and maintained per equipment instructions and in compliance with applicable manufacturers suggested maintenance and calibration stand-ards. (12) Have technical staff on duty with the appropriate credentials to perform tests. The IDTF must be able to produce the applicable Federal or State licenses or certifications of the individ-uals performing these services. (13) Have proper medical record stor-age and be able to retrieve medical records upon request from CMS or its fee-for-service contractor within 2 business days. (14) Permit CMS, including its agents, or its designated fee-for-service contractors, to conduct unannounced, on-site inspections to confirm the IDTFs compliance with these stand-ards. The IDTF must (i) Be accessible during regular busi-ness hours to CMS and beneficiaries; and (ii) Maintain a visible sign posting its normal business hours. (15) With the exception of hospital- based and mobile IDTFs, a fixed-base IDTF is prohibited from the following: (i) Sharing a practice location with another Medicare-enrolled individual or organization; (ii) Leasing or subleasing its oper-ations or its practice location to an-other Medicare-enrolled individual or organization; or (iii) Sharing diagnostic testing equip-ment used in the initial diagnostic test with another Medicare-enrolled indi-vidual or organization. (16) Enrolls for any diagnostic testing services that it furnishes to a Medicare beneficiary, regardless of whether the service is furnished in a mobile or fixed base location. (17) Bills for all mobile diagnostic services that are furnished to a Medi-care beneficiary, unless the mobile di-agnostic service is part of a service provided under arrangement as de-scribed in section 1861(w)(1) of the Act. (h) Failure to meet standards. If an IDTF fails to meet one or more of the standards in paragraph (g) of this sec-tion at the time of enrollment, its en-rollment will be denied. CMS will re-voke a suppliers billing privileges if and IDTF is found not to meet the standards in paragraph (g) or (b)(1) of this section. (i) Effective date of billing privileges. The filing date of the Medicare enroll-ment application is the date that the Medicare contractor receives a signed provider enrollment application that it is able to process to approval. The ef-fective date of billing privileges for a newly enrolled IDTF is the later of the following: (1) The filing date of the Medicare en-rollment application that was subse-quently approved by a Medicare fee- for-service contractor; or VerDate Sep<11>2014 17:46 Oct 23, 2015 Jkt 235189 PO 00000 Frm 00387 Fmt 8010 Sfmt 8010 Q:\42\42V2.TXT 31lpowell on DSK54DXVN1OFR with $$_JOB378 42 CFR Ch. IV (10115 Edition)  410.34 (2) The date the IDTF first started furnishing services at its new practice location. [62 FR 59099, Oct. 31, 1997, as amended at 64 FR 59440, Nov. 2, 1999; 71 FR 69784, Dec. 1, 2006; 72 FR 18914, Apr. 16, 2007; 72 FR 66398, Nov. 27, 2007; 73 FR 2432, Jan. 15, 2008; 73 FR 69933, Nov. 19, 2008; 73 FR 80304, Dec. 31, 2008]  410.34 Mammography services: Con-ditions for and limitations on cov-erage. (a) Definitions. As used in this sec-tion, the following definitions apply: (1) Diagnostic mammography means a radiologic procedure furnished to a man or woman with signs or symptoms of breast disease, or a personal history of breast cancer, or a personal history of biopsy-proven benign breast disease, and includes a physicians interpreta-tion of the results of the procedure. (2) Screening mammography means a radiologic procedure furnished to a woman without signs or symptoms of breast disease, for the purpose of early detection of breast cancer, and includes a physicians interpretation of the re-sults of the procedure. (3) Supplier of diagnostic mammography means a facility that is certified and responsible for ensuring that all diag-nostic mammography services fur-nished to Medicare beneficiaries meet the conditions for coverage of diag-nostic mammography services as speci-fied in paragraph (b) of this section. (4) Supplier of screening mammography means a facility that is certified and responsible for ensuring that all screening mammography services fur-nished to Medicare beneficiaries meet the conditions and limitations for cov-erage of screening mammography serv-ices as specified in paragraphs (c) and (d) of this section. (5) Certificate means the certificate described in 21 CFR 900.2(b) that may be issued to, or renewed for, a facility that meets the requirements for con-ducting an examination or procedure involving mammography. (6) Provisional certificate means the provisional certificate described in 21 CFR 900.2(m) that may be issued to a facility to enable the facility to qualify to meet the requirements for con-ducting an examination or procedure involving mammography. (7) The term meets the certification re-quirements of section 354 of the Public Health Service (PHS) Act means that in order to qualify for coverage of its services under the Medicare program, a supplier of diagnostic or screening mammography services must meet the following requirements: (i) Must have a valid provisional cer-tificate, or a valid certificate, that has been issued by FDA indicating that the supplier meets the certification re-quirements of section 354 of the PHS Act, as implemented by 21 CFR part 900, subpart B. (ii) Has not been issued a written no-tification by FDA that states that the supplier must cease conducting mam-mography examinations because the supplier is not in compliance with cer-tain critical certification requirements of section 354 of the PHS Act, imple-mented by 21 CFR part 900, subpart B. (iii) Must not employ for provision of the professional component of mam-mography services a physician or phy-sicians for whom the facility has re-ceived written notification by FDA that the physician (or physicians) is (or are) in violation of the certification re-quirements set forth in section 354 of the PHS Act, as implemented by 21 CFR 900.12(a)(1)(i). (b) Conditions for coverage of diag-nostic mammography services. Medicare Part B pays for diagnostic mammog-raphy services if they meet the fol-lowing conditions: (1) They are ordered by a doctor of medicine or osteopathy (as defined in section 1861(r)(1) of the Act). (2) They are furnished by a supplier of diagnostic mammography services that meets the certification require-ments of section 354 of the PHS Act, as implemented by 21 CFR part 900, sub-part B. (c) Conditions for coverage of screening mammography services. Medicare Part B pays for screening mammography serv-ices if they are furnished by a supplier of screening mammography services that meets the certification require-ments of section 354 of the PHS Act, as implemented by 21 CFR part 900, sub-part B. (d) Limitations on coverage of screening mammography services. The following limitations apply to coverage of VerDate Sep<11>2014 17:46 Oct 23, 2015 Jkt 235189 PO 00000 Frm 00388 Fmt 8010 Sfmt 8010 Q:\42\42V2.TXT 31lpowell on DSK54DXVN1OFR with $$_JOB