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

374 42 CFR Ch. IV (10115 Edition)  410.33 (2) Documentation and recordkeeping requirements (i) Ordering the service. The physician or (qualified nonphysican practitioner, as defined in paragraph (a)(2) of this section), who orders the service must maintain docu-mentation of medical necessity in the beneficiarys medical record. (ii) Submitting the claim. The entity submitting the claim must maintain the following documentation: (A) The documentation that it re-ceives from the ordering physician or nonphysician practitioner. (B) The documentation that the in-formation that it submitted with the claim accurately reflects the informa-tion it received from the ordering phy-sician or nonphysician practitioner. (iii) Requesting additional information. The entity submitting the claim may request additional diagnostic and other medical information to document that the services it bills are reasonable and necessary. If the entity requests addi-tional documentation, it must request material relevant to the medical neces-sity of the specific test(s), taking into consideration current rules and regula-tions on patient confidentiality. (3) Claims review. (i) Documentation re-quirements. Upon request by CMS, the entity submitting the claim must pro-vide the following information: (A) Documentation of the order for the service billed (including informa-tion sufficient to enable CMS to iden-tify and contact the ordering physician or nonphysician practitioner). (B) Documentation showing accurate processing of the order and submission of the claim. (C) Diagnostic or other medical infor-mation supplied to the laboratory by the ordering physician or nonphysician practitioner, including any ICD9CM code or narrative description supplied. (ii) Services that are not reasonable and necessary. If the documentation pro-vided under paragraph (d)(3)(i) of this section does not demonstrate that the service is reasonable and necessary, CMS takes the following actions: (A) Provides the ordering physician or nonphysician practitioner informa-tion sufficient to identify the claim being reviewed. (B) Requests from the ordering physi-cian or nonphysician practitioner those parts of a beneficiarys medical record that are relevant to the specific claim(s) being reviewed. (C) If the ordering physician or non-physician practitioner does not supply the documentation requested, informs the entity submitting the claim(s) that the documentation has not been sup-plied and denies the claim. (iii) Medical necessity. The entity sub-mitting the claim may request addi-tional diagnostic and other medical in-formation from the ordering physician or nonphysician practitioner to docu-ment that the services it bills are rea-sonable and necessary. If the entity re-quests additional documentation, it must request material relevant to the medical necessity of the specific test(s), taking into consideration cur-rent rules and regulations on patient confidentiality. (4) Automatic denial and manual re-view. (i) General rule. Except as pro-vided in paragraph (d)(4)(ii) of this sec-tion, CMS does not deny a claim for services that exceed utilization param-eters without reviewing all relevant documentation that is submitted with the claim (for example, justifications prepared by providers, primary and sec-ondary diagnoses, and copies of med-ical records). (ii) Exceptions. CMS may automati-cally deny a claim without manual re-view if a national coverage decision or LMRP specifies the circumstances under which the service is denied, or the service is specifically excluded from Medicare coverage by law. (e) Diagnostic laboratory tests fur-nished in hospitals and CAHs. The provi-sions of paragraphs (a) and (d)(2) through (d)(4) of this section, inclusive, of this section apply to all diagnostic laboratory test furnished by hospitals and CAHs to outpatients. [62 FR 59098, Oct. 31, 1997, as amended at 63 FR 26308, May 12, 1998; 63 FR 53307, Oct. 5, 1998; 63 FR 58906, Nov. 2, 1998; 64 FR 59440, Nov. 2, 1999; 66 FR 58809, Nov. 23, 2001; 69 FR 66421, Nov. 15, 2004; 72 FR 66398, Nov. 27, 2007; 75 FR 73615, Nov. 29, 2010; 77 FR 69361, Nov. 16, 2012]  410.33 Independent diagnostic test-ing facility. (a) General rule. (1) Effective for diag-nostic procedures performed on or after VerDate Sep<11>2014 17:46 Oct 23, 2015 Jkt 235189 PO 00000 Frm 00384 Fmt 8010 Sfmt 8010 Q:\42\42V2.TXT 31lpowell on DSK54DXVN1OFR with $$_JOB375 Centers for Medicare & Medicaid Services, HHS  410.33 March 15, 1999, carriers will pay for di-agnostic procedures under the physi-cian fee schedule only when performed by a physician, a group practice of phy-sicians, an approved supplier of port-able x-ray services, a nurse practi-tioner, or a clinical nurse specialist when he or she performs a test he or she is authorized by the State to per-form, or an independent diagnostic testing facility (IDTF). An IDTF may be a fixed location, a mobile entity, or an individual nonphysician practi-tioner. It is independent of a physi-cians office or hospital; however, these rules apply when an IDTF furnishes di-agnostic procedures in a physicians of-fice. (2) Exceptions. The following diag-nostic tests that are payable under the physician fee schedule and furnished by a nonhospital testing entity are not re-quired to be furnished in accordance with the criteria set forth in para-graphs (b) through (e) and (g) and (h) of this section. (i) Diagnostic mammography proce-dures, which are regulated by the Food and Drug Administration. (ii) Diagnostic tests personally fur-nished by a qualified audiologist as de-fined in section 1861(ll)(3) of the Act. (iii) Diagnostic psychological testing services personally furnished by a clin-ical psychologist or a qualified inde-pendent psychologist as defined in pro-gram instructions. (iv) Diagnostic tests (as established through program instructions) person-ally performed by a physical therapist who is certified by the American Board of Physical Therapy Specialties as a qualified electrophysiologic clinical specialist and permitted to provide the service under State law. (b) Supervising physician. (1) Each su-pervising physician must be limited to providing general supervision to no more than three IDTF sites. This ap-plies to both fixed sites and mobile units where three concurrent oper-ations are capable of performing tests. (2) The supervising physician must evidence proficiency in the perform-ance and interpretation of each type of diagnostic procedure performed by the IDTF. The proficiency may be docu-mented by certification in specific medical specialties or subspecialties or by criteria established by the carrier for the service area in which the IDTF is located. In the case of a procedure requiring the direct or personal super-vision of a physician as set forth in 410.32(b)(3)(ii) or (b)(3)(iii), the IDTFs supervising physician must personally furnish this level of supervision wheth-er the procedure is performed in the IDTF or, in the case of mobile services, at the remote location. The IDTF must maintain documentation of sufficient physician resources during all hours of operations to assure that the required physician supervision is furnished. In the case of procedures requiring direct supervision, the supervising physician may oversee concurrent procedures. (c) Nonphysician personnel. Any non-physician personnel used by the IDTF to perform tests must demonstrate the basic qualifications to perform the tests in question and have training and proficiency as evidenced by licensure or certification by the appropriate State health or education department. In the absence of a State licensing board, the technician must be certified by an appropriate national credentialing body. The IDTF must maintain documentation available for review that these requirements are met. (d) Ordering of tests. All procedures performed by the IDTF must be specifi-cally ordered in writing by the physi-cian who is treating the beneficiary, that is, the 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).) The order must specify the diagnosis or other basis for the testing. The super-vising physician for the IDTF may not order tests to be performed by the IDTF, unless the IDTFs supervising physician is in fact the beneficiarys treating physician. That is, the physi-cian in question had a relationship with the beneficiary prior to the per-formance of the testing and is treating the beneficiary for a specific medical problem. The IDTF may not add any procedures based on internal protocols without a written order from the treat-ing physician. VerDate Sep<11>2014 17:46 Oct 23, 2015 Jkt 235189 PO 00000 Frm 00385 Fmt 8010 Sfmt 8010 Q:\42\42V2.TXT 31lpowell on DSK54DXVN1OFR with $$_JOB376 42 CFR Ch. IV (10115 Edition)  410.33 (e) Multi-State entities. (1) An IDTF that operates across State boundaries must (i) Maintain documentation that its supervising physicians and technicians are licensed and certified in each of the States in which it operates; and (ii) Operate in compliance with all applicable Federal, State, and local li-censure and regulatory requirements with regard to the health and safety of patients. (2) The point of the actual delivery of service means the place of service on the claim form. When the IDTF per-forms or administers an entire diag-nostic test at the beneficiarys loca-tion, the beneficiarys location is the place of service. When one or more as-pects of the diagnostic testing are per-formed at the IDTF, the IDTF is the place of service. (f) Applicability of State law. An IDTF must comply with the applicable laws of any State in which it operates. (g) Application certification standards. The IDTF must certify in its enroll-ment application that it meets the fol-lowing standards and related require-ments: (1) Operates its business in compli-ance with all applicable Federal and State licensure and regulatory require-ments for the health and safety of pa-tients. (2) Provides complete and accurate information on its enrollment applica-tion. Changes in ownership, changes of location, changes in general super-vision, and adverse legal actions must be reported to the Medicare fee-for- service contractor on the Medicare en-rollment application within 30 calendar days of the change. All other changes to the enrollment application must be reported within 90 days. (3) Maintain a physical facility on an appropriate site. For the purposes of this standard, a post office box, com-mercial mailbox, hotel, or motel is not considered an appropriate site. (i) The physical facility, including mobile units, must contain space for equipment appropriate to the services designated on the enrollment applica-tion, facilities for hand washing, ade-quate patient privacy accommoda-tions, and the storage of both business records and current medical records within the office setting of the IDTF, or IDTF home office, not within the ac-tual mobile unit. (ii) IDTF suppliers that provide serv-ices remotely and do not see bene-ficiaries at their practice location are exempt from providing hand washing and adequate patient privacy accom-modations. (4) Has all applicable diagnostic test-ing equipment available at the phys-ical site excluding portable diagnostic testing equipment. The IDTF must (i) Maintain a catalog of portable di-agnostic equipment, including diag-nostic testing equipment serial num-bers at the physical site; (ii) Make portable diagnostic testing equipment available for inspection within 2 business days of a CMS inspec-tion request. (iii) Maintain a current inventory of the diagnostic testing equipment, 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