National Coverage Determination. Vagus Nerve Stimulation (VNS)

Transcription

1 National Coverage Determination Vagus Nerve Stimulation (VNS) Number NEURO-004 Contractor Name Wisconsin Physicians Service Insurance Corporation AMA CPT Copyright Statement CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply CMS National Coverage Policy Vagus Nerve Stimulation CMS Effective Date Indications and Limitations of Coverage A. General VNS is a pulse generator, similar to a pacemaker, that is surgically implanted under the skin of the left chest and an electrical lead (wire) is connected from the generator to the left vagus nerve. Electrical signals are sent from the battery-powered generator to the vagus nerve via the lead. These signals are in turn sent to the brain. FDA approved VNS for treatment of refractory epilepsy in 1997 and for resistant depression in B. Nationally Covered Indications Effective for services performed on or after July 1, 1999, VNS is reasonable and necessary for patients with medically refractory partial onset seizures for whom surgery is not recommended or for whom surgery has failed. C. Nationally Non-Covered Indications Effective for services performed on or after July 1, 1999, VNS is not reasonable and necessary for all other types of seizure disorders which are medically refractory and for whom surgery is not recommended or for whom surgery has failed. Effective for services performed on or after May 4, 2007, is not reasonable and necessary for resistant depression D. Other Also see 160, "Electrical Nerve Stimulators." (This NCD last reviewed by CMS May 2007.) Source Rev. 70, Issued: ; Effective: ; Implementation:

2 See Vagus Nerve Stimulation NEURO-004: Billing and Coding Guidelines is a national coverage determination (NCD). NCDs are binding on all carriers, fiscal intermediaries, quality improvement organizations, qualified independent contractors, the Medicare Appeals Council, and administrative law judges (ALJs) (see 42 CFR section (a)(4) (2005)). An NCD that expands coverage is also binding on a Medicare advantage organization. In addition, an ALJ may not review an NCD. (See section 1869(f)(1)(A)(i) of the Social Security Act.) Italicized font represents CMS national NCD language/wording copied directly from CMS Manuals or CMS Transmittals. Carriers are prohibited from changing national NCD language/wording. Providers, through their associations/societies, should contact CMS to request changes to NCDs through the Medicare Coverage Policy Process at An asterisk (*) indicates a revision to that section of the NCD Start Date of Notice Period (Published) Existing regulations Revision History

3 Billing and Coding Guideline NCD NEURO-004 Vagus Nerve Stimulation AMA CPT/ADA CDT Copyright Statement CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply CMS National Coverage Policy Vagus Nerve Stimulation for Treatment of Seizures VNS is a pulse generator, similar to a pacemaker, that is surgically implanted under the skin of the left chest and an electrical lead (wire) is connected from the generator to the left vagus nerve. Electrical signals are sent from the battery-powered generator to the vagus nerve via the lead. These signals are in turn sent to the brain. FDA approved VNS for treatment of refractory epilepsy in 1997 and for resistant depression in Note that FDA approval of any device does not necessarily confer Medicare or commercial insurance reimbursement. Effective for services performed on or after July 1, 1999, VNS is reasonable and necessary for patients with medically refractory partial onset seizures for whom surgery is not recommended or for whom surgery has failed. There is no coverage for vagus nerve stimulation for patient with resistant depression. Coding Information Bill Type Codes: Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims. 011x Hospital Inpatient (Including Medicare Part A) 012x Hospital Inpatient (Medicare Part B only) 013x Hospital Outpatient 071x Clinic - Rural Health 073x Clinic - Freestanding 077x Clinic Federally Qualified Health Center (FQHC) 085x Critical Access Hospital Revenue Codes: Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the article services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

4 Revenue codes only apply to providers who bill these services to the fiscal intermediary or Part A MAC. Revenue codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC. Please note that not all revenue codes apply to every type of bill code. Providers are encouraged to refer to the FISS revenue code file for allowable bill types. Similarly, not all revenue codes apply to each CPT/HCPCS code. Providers are encouraged to refer to the FISS HCPCS file for allowable revenue codes. All revenue codes billed on the inpatient claim for the dates of service in question may be subject to review Medical/Surgical Supplies and Devices - Other Implant 036X Operating Room Services - General Classification 049X Ambulatory Surgical Care - General Classification 051X Clinic - General Classification 052X Free-Standing Clinic - General Classification 076X Specialty Services - General Classification 096X Professional Fees - General Classification 0975 Professional Fees - Operating Room 0982 Professional Fees - Outpatient Services CPT/HCPCS Codes for Vagus Nerve Stimulation (VNS) Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array Percutaneous implantation of neurostimulator electrodes; cranial nerve Incision for implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator Revision or replacement of cranial nerve(eg, vagus nerve) neurostimulator electrode array, including connection to pulse generator Removal of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple or complex brain, spinal cord, or peripheral (ie, cranial nerve, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming Electronic analysis of implanted neurostimulator pulse generator system (eg,rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex cranial nerve neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, with or without nerve interface testing, first hour Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and Patient compliance measurements); complex cranial nerve neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, each additional 30 minutes after first hour (list separately in addition to code for primary procedure) C1767 Generator, neurostimulator (implantable), non-rechargeable

5 C1778 Lead, neurostimulator (implantable) VNS is billed using both CPT codes and on the same claim. General practice is for the neurosurgeon alone to bill for the surgery. He/she makes the pocket (CPT 61885) as well as placing and evaluating the leads (CPT 64553). A separate procedure code for electronic analysis services (CPT or or 95975) may be appropriate if the neurologist/neurophysiology team adjusts and initiates initial stimulus levels in the operating room. Co-surgeons are not necessary. Standby services are not covered. Assistant-at-surgery is not payable for these procedures. ICD-9 codes that support medical necessity: One of the following diagnosis codes must be reported, as appropriate, when billing for Vagus Nerve Stimulation: Localization-related (focal) (partial) epilepsy and epileptic syndromes with complex partial seizures with intractable epilepsy Localization-related (focal) (partial) epilepsy and epileptic syndromes with simple partial seizures with intractable epilepsy There is no coverage for vagus nerve stimulation for patient with resistant depression. ICD-9 Codes that DO NOT Support Medical Necessity Major depressive disorder unspec Major depressive disorder mild Major depressive disorder mod Major depressive disorder severe Major depressive sever w/psych Major depressive partial remission Major depressive full remission Recurrent major depressive unsp Recurrent major depressive mild Recurrent major depressive mod Recurrent major depressive severe Recurrent major depressive psychotic Recurrent major depressive part remission Recurrent major depressive full remission Bipolar affective depressive unsp Bipolar affect depressive mild Bipolar affect depressive mod Bipolar affective depressive severe Bipolar depressive sever w/psych Bipolar affective depressive partial remission Bipolar affective depressive remission Manic depressive unspecified Atypical depressive disorder Manic depressive other Depressive type psychosis Dysthymic disorder Chronic depressive personality disorder Antidepress abuse unspec

6 Antidepress abuse contin Antidepress abuse episode Antidepress abuse remiss Adjustment disorder with depressed mood Prolong depressive react 311 Depressive disorder, NOS A. Coding Guidelines 1. List the appropriate ICD-9 code to indicate the reason for the service(s). 2. General practice is for the neurosurgeon alone to bill for the surgery. He/she makes the pocket as well as placing and evaluating the leads. A separate procedure code for electronic analysis services may be appropriate if the neurologist/neurophysiology team adjusts and initiates initial stimulus levels in the operating room. Co-surgeons are not necessary. Standby services are not covered. Assistant-at-surgery is not payable for these procedures. 3. An evaluation and management (E&M) visit may be separately paid with the same date of service as a neurostimulator analysis ( ) only if the visit constituted a significant and separately identifiable service. The physician needs to satisfy the elements of an E&M visit (e.g., history, exam, medical decision making), and the patient record must reflect the medical necessity of a separately identifiable E&M (e.g., patient has new or changed symptoms, analysis of neurostimulator reveals need for additional exam, etc.). If the physician merely analyses an implanted neurostimulator pulse generator system, no E&M may be paid. To indicate it is a separately identifiable service, use the -25 modifier. 4. When VNS is performed for indications other than intractable epilepsy the service should be billed with either a GA or a GZ modifier and the claim will be denied as not medically necessary. 5. Open incision for implantation of a neurostimulator electrode on the Vagus nerve (a cranial nerve) with connection of the electrode to an implanted programmable pulse generator in the infraclavicular area. Both services must be billed on the same claim. 6 Surgery under local anesthesia will be considered to be medically necessary to replace the battery every three years. 7. Frequency of monitoring the VNS is the responsibility of the physician based on many factors, i.e., the age of the system, product alert, battery failure (product or patient use dependent), intrinsic wire lead malfunction, pocket complications, the patient s medical condition, a change in programming, electrode failure, or signal generator malfunction. 8. Claims for CPT codes 61885, 64553, 64568, 64569, and are payable under Medicare Part B in the following places of service: office (11), inpatient hospital (21), outpatient hospital (22), ambulatory surgical center (24), and independent clinic (49).

7 For claims submitted to the Fiscal Intermediary or Part A MAC: Hospital Inpatient Claims: 1. The hospital should report the patient's principal diagnosis in Form Locator (FL) 67 of the UB-04. The principal diagnosis is the condition established after study to be chiefly responsible for this admission. 2. The hospital enters ICD-9-CM codes for up to eight additional conditions in FLs 67A- 67Q if they co-existed at the time of admission or developed subsequently, and which had an effect upon the treatment or the length of stay. It may not duplicate the principal diagnosis listed in FL For inpatient hospital claims, the admitting diagnosis is required and should be recorded in FL 69. (See CMS Publication , Medicare Claims Processing Manual, Chapter 25, Section 75 for additional instructions.): Hospital Outpatient Claims: 1. The hospital should report the full ICD-9-CM code for the diagnosis shown to be chiefly responsible for theoutpatient services in FL 67. If no definitive diagnosis is made during the outpatient evaluation, the patient's symptom is reported. If the patient arrives without a referring diagnosis, symptom or complaint, the provider should report an ICD-9-CM code for Persons Without Reported Diagnosis Encountered During Examination and Investigation of Individuals and Populations (V70-V82). 2. The hospital enters the full ICD-9-CM codes in FLs 67A-67Q for up to eight other diagnoses that co-existed in addition to the diagnosis reported in FL 67. For dates of service prior to April 1, 2010, FQHC services should be reported with bill type 73X. For dates of service on or after April 1, 2010, bill type 77X should be used to report FQHC services. B. Documentation Requirements Patient's clinical records are not necessary for claims submission. However, records must be available upon request and must contain documentation that is listed in the indications and limitations of coverage and/or medical necessity. The documentation must also indicate that: 1. Appropriate medications have been tried and failed to significantly control a person s seizures. This includes both conventional medications, i.e., Phenytoin, Carbamazepine or Valproate as well as newer anticonvulsant drugs (Ex: Lamotrigine, Vigabatrin or Topiramate or Tiagabine) given as add-on treatments. 2. There is reason to believe that Quality of Life (QOL) will be improved as a result of VNS. The treating physician must document this opinion clearly in the medical record before recommending VNS. 3. The seizures have been documented by EEG or video monitoring. Non-epileptic seizures and behavioral aberrations including self-injurious behavior are ruled out. 4. VNS is the preferred mode of therapy. C. Reasons for Denial 1. VNS performed for indications other than medically refractory partial onset seizures for whom surgery is not recommended or for whom surgery has failed. 2. Medical records that do not contain documentation of information contained in "Indications and Limitations of Coverage." 3. Implant performed without documentation that appropriate medications were tried and failed to significantly control a person s seizures.

8 4. Billing for readjust or reposition of implant within 15 days of the initial insertion are considered covered under the initial service and reimbursement. 5. VNS for primary generalized seizures as trials have not yet demonstrated efficacy of this procedure. 6. Medical records are not made available upon request. 7. There is no coverage for vagus nerve stimulation for patient with resistant depression. The following CPT codes may not be paid with a diagnosis of depression and/or related disorders PER Vagus Nerve Stimulation for Treatment of Seizures Vagus Nerve Stimulation is not covered for patients with other types of seizure disorders which are medically refectory and for whom surgery is not recommended or for whom surgery has failed. Note: * - An asterisk indicates a revision to that section of the policy. Italicized Font- represents CMS national policy language/wording copied directly from CMS Manuals or CMS Transmittals. Carriers are prohibited form changing national policy language/wording. Providers, through their associations/societies, should contact CMS to request changes to national policy through the Medicare Coverage Policy Process at CMS Effective Date Published/Website: 10/01/2012 Revision History: 10/01/2012 Annual review, reformatted, added codes 64568, 64569,(effective 01/01/2011)C1767, C1778, removed codes 95971, 95972, 95973, 95978, 95979, 64590, /01/2012, updated CPT definitions;