evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: Single Chamber and Dual Chamber Permanent Cardiac Pacemakers – Coding and Billing (A54931)
In addition, use of modifier - KX may be used in patients without symptoms in Groups I and II in the following situations:Awake, symptomfree patients in sinus rhythm, with documented periods of asystole greater than or equal to 3.0 seconds or any escape rate less than 40 beats per minute (bpm), or with an escape rhythm that is below the AV nodeAwake, symptom-free patients with atrial fibrillation and bradycardia with one or more pauses of at least 5 seconds or longerCatheter ablation of the AV junctionPostoperative AV block that is not expected to resolve after cardiac surgeryPatients with neuromuscular diseases, e.g., myotonic muscular dystrophy, Kearns-Sayre syndrome, Erb dystrophy, and peroneal muscular atrophy, with third-degree and advanced second-degree AV block at any anatomic levelAsymptomatic persistent third-degree AV block at any anatomic site with average awake ventricular rates of 40 bpm or faster if cardiomegaly or LV dysfunction is present or if the site of block is below the AV nodeSecond or third-degree AV block during exercise in the absence of myocardial ischemiaPersistent third-degree AV block with an escape rate greater than 40 bpm in asymptomatic adult patients without cardiomegalyAsymptomatic second-degree AV block at intra-or infra-His levels found at electrophysiological studyFirst- or second-degree AV block with symptoms similar to those of pacemaker syndrome or hemodynamic compromiseAsymptomatic type II second-degree AV block with a narrow QRS. Second-degree AV block with a wide QRS including isolated right bundle-branch blockFor medically necessary pacemaker insertion in conditions not addressed by the NCD or this article,Group III, use modifier - SC (Medically necessary service or supply).Modifiers  GA and  GZ:
Article - Billing and Coding: Single Chamber and Dual Chamber Permanent Cardiac Pacemakers – Coding and Billing (A54931)
For medically necessary pacemaker insertion in conditions not addressed by the NCD or this article,Group III, use modifier - SC (Medically necessary service or supply).Modifiers  GA and  GZ:Modifier  GA (Waiver of liability statement issued as required by payer policy, individual case) should be used when the provider wants to indicate that he/she anticipates that Medicare will deny a specific service as not reasonable and necessary, an Advanced Beneficiary Notice (ABN) Form CMS-R-131 has been signed by the beneficiary and is on file. Modifier  GA may also be used on assigned claims when a patient refuses to sign the ABN and the latter is properly witnessed. For claims submitted to the Part A MAC, occurrence code 32 and the date of the ABN are required.Modifier  GZ should be used when the provider wants to indicate that it is expected that Medicare will deny the specific services as not reasonable and necessary and the beneficiary was not asked to sign an ABN.Claims for pacemaker claims that do not meet the criteria for modifier  KX or  SC should have modifier  GA or  GZ appended depending on the ABN status and will be denied.
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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
CFR-2015-title42-vol2-sec410-33.pdf
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
CFR-2015-title42-vol2-sec410-33.pdf
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
CFR-2015-title42-vol2-sec410-33.pdf
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
CFR-2015-title42-vol2-sec410-33.pdf
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
CFR-2015-title42-vol2-sec410-33.pdf
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
CFR-2015-title42-vol2-sec410-33.pdf
(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 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
CFR-2015-title42-vol2-sec410-33.pdf
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,
CFR-2015-title42-vol2-sec410-33.pdf
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
CFR-2015-title42-vol2-sec410-33.pdf
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