FUTURE DRAFT Local Coverage Determination for Chemodenervation (DL31701)

Transcription

1 FUTURE DRAFT Local Coverage Determination for Chemodenervation (DL31701) Page 1 of 14 Search Home Medicare Medicaid CHIP About CMS Regulations & Guidance Research, Statistics, Data & Systems Outreach & Education People with Medicare & Medicaid Questions Careers Newsroom Contact CMS Acronyms Help Print Back to Local Coverage Determinations (LCDs) for Palmetto GBA (11502, MAC - Part B) FUTURE DRAFT Local Coverage Determination (LCD) for Chemodenervation (DL31701) Select the Print Record, Add to Basket or Record buttons to print the record, to add it to your basket or to the record. Section Navigation Select Section Go Please note: This is a Draft policy. Draft LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Draft LCDs are not necessarily a reflection of the current policies or practices of the contractor. Please note: This is a Future Draft LCD. Contractor Information Contractor Name Palmetto GBA Contractor Number Contractor Type MAC - Part B Back to Top LCD Information Document Information

2 FUTURE DRAFT Local Coverage Determination for Chemodenervation (DL31701) Page 2 of 14 LCD ID Number DL31701 LCD Title Chemodenervation Contractor's Determination Number L21803 AMA CPT/ADA CDT Copyright Statement CPT only copyright American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association. Primary Geographic Jurisdiction North Carolina Oversight Region Region IV Original Determination Effective Date For services performed on or after 01/17/2013 Original Determination Ending Date Revision Effective Date Revision Ending Date CMS National Coverage Policy Title XVIII of the Social Security Act, 1862 (a)(1)(a) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Title XVIII of the Social Security Act, 1862 (a)(1)(d) No payment can be made for services that are for research or experimentation. Title XVIII of the Social Security Act 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim. CMS Internet-Only Manual, Pub , Medicare Benefit Policy Manual, Chapter 15, CMS Internet-Only Manual, Pub , Medicare National Coverage Determinations Manual, Chapter 1, Part 2, Indications and Limitations of Coverage and/or Medical Necessity Chemodenervation refers to the use of chemical agents to produce neuromuscular blockade for the purpose of selective weakening of specific muscles, or muscle groups.

3 FUTURE DRAFT Local Coverage Determination for Chemodenervation (DL31701) Page 3 of 14 This policy applies to the use of neurotoxins as well as other chemical agents used for this purpose. Chemodenervation techniques are indicated for: 1. Chemodenervation of muscle innervated by the facial nerve in the management of blepharospasm or hemifacial spasm. 2. Chemodenervation of cervical spinal muscles in the management of spasmodic torticollis. 3. Chemodenervation of extremity muscles in the management of dystonias, cerebral palsy and multiple sclerosis. 4. Chemodenervation of extraocular muscles in the management of strabismus. 5. Chemodenervation of the lower esophageal sphincter in the management of achalasia. 6. Chemodenervation of laryngeal muscles in the treatment of adductor spasmodic dysphonia. 7. Chemodenervation of bilateral frontalis, trapezius, temporalis, sternocleidomastoid, and splenium capitis muscles for treatment of chronic tension headache, chronic migraine, and intractable daily headache. 8. Chemodenervation of axillary sweat glands for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents. Severe is defined for this purpose as level 3 (underarm sweating barely tolerable/frequently interferes with daily activities) or level 4 (underarm sweating intolerable/always interferes with daily activities) on the Hyperhidrosis Disease Severity Scale (HDSS). 9. Chemodenervation of the internal anal sphincter for the treatment of chronic anal fissure. 10. Chemodenervation of the detrusor urinae muscle for the treatment of overactivity associated with a neurologic condition in adults with an inadequate response to anticholinergic treatment. 11. Chemodenervation of the parotid and submandibular salivary glands, bilaterally Limitations Chemodenervation for the treatment of headaches is limited to patients who experience headaches that may result in permanent cerebral dysfunction, or who are intractable because they cannot tolerate or do not benefit from standard therapies. Candidates for this treatment are patients with: 1. Intractable migraine (with or without aura). 2. Intractable chronic tension-type headache with moderate to severe pain. 3. Chronic daily headaches defined as patients experiencing more than 15 days of headache per month either migraine or tension-type features. Intractable headache is defined as a patient meeting one of the following criteria for treatment: 1. Failed trails of at least three preventive pharmacologic migraine therapies (e.g. beta-

4 FUTURE DRAFT Local Coverage Determination for Chemodenervation (DL31701) Page 4 of 14 blockers, calcium channel blockers, anticonvulsants, antidepressants) with or without concomitant behavioral and physical therapies, after titration to maximal tolerated doses or have medical contraindications to common therapies or who cannot tolerate common preventative therapies; or 2. Experience chronic daily headaches or recurrent headaches at least twice per month causing disability lasting three or more days per month; or 3. Standard abortive medication is required more than twice per week, or is contraindicated, ineffective or not tolerated. Back to Top 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 policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims. 999x Not Applicable 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 policy 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 policy should be assumed to apply equally to all Revenue Codes Not Applicable CPT/HCPCS Codes CPT Codes Esoph scope w/submucous inj Chemodenervation anal musc Chemodenerv saliv glands Destroy nerve face muscle

5 FUTURE DRAFT Local Coverage Determination for Chemodenervation (DL31701) Page 5 of Destroy nerve neck muscle Destroy nerve extrem musc Chemodenerv eccrine glands Destroy nerve of eye muscle Guide nerv destr elec stim Guide nerv destr needle emg Use CPT code and in addition to code for primary procedure (CPT codes J0585 J0586 J0587 J0588 Injection,onabotulinumtoxinA AbobotulinumtoxinA Inj, rimabotulinumtoxinb Incobotulinumtoxin a ICD-9 Codes that Support Medical Necessity Use of these codes does not guarantee reimbursement. The patient's medical record must document that the coverage criteria in this policy have been met. CPT code 43201; HCPCS codes J0585, J0586, J0587, J ACHALASIA AND CARDIOSPASM CPT codes 46505; HCPCS codes J0585, J0586, J0587, J ANAL FISSURE CPT code 64611; HCPCS code J DISTURBANCE OF SALIVARY SECRETION CPT code 64612; HCPCS codes J0585, J0586, J0587, J TENSION HEADACHE BLEPHAROSPASM OROFACIAL DYSKINESIA CHRONIC CLUSTER HEADACHE CHRONIC TENSION TYPE HEADACHE

6 FUTURE DRAFT Local Coverage Determination for Chemodenervation (DL31701) Page 6 of MIGRAINE WITH AURA, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS MIGRAINE WITH AURA, WITHOUT MENTION OF INTRACTABLE MIGRAINE WITH STATUS MIGRAINOSUS MIGRAINE WITH AURA, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS MIGRAINE WITHOUT AURA, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS MIGRAINE WITHOUT AURA, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS VARIANTS OF MIGRAINE, NOT ELSEWHERE CLASSIFIED, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS VARIANTS OF MIGRAINE, NOT ELSEWHERE CLASSIFIED, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS HEMIPLEGIC MIGRAINE, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS HEMIPLEGIC MIGRAINE, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS MENSTRUAL MIGRAINE, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS MENSTRUAL MIGRAINE, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS PERSISTENT MIGRAINE AURA WITHOUT CEREBRAL INFARCTION, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS PERSISTENT MIGRAINE AURA WITHOUT CEREBRAL INFARCTION, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS PERSISTENT MIGRAINE AURA WITH CEREBRAL INFARCTION, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS PERSISTENT MIGRAINE AURA WITH CEREBRAL INFARCTION, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS OTHER FORMS OF MIGRAINE, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS OTHER FORMS OF MIGRAINE, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS

7 FUTURE DRAFT Local Coverage Determination for Chemodenervation (DL31701) Page 7 of MIGRAINE, UNSPECIFIED, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS MIGRAINE, UNSPECIFIED, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS TRIGEMINAL NERVE DISORDER UNSPECIFIED OTHER FACIAL NERVE DISORDERS - FACIAL NERVE DISORDER UNSPECIFIED SPASTIC ENTROPION CPT code 64613; HCPCS codes J0585, J0586, J0587, J TENSION HEADACHE SPASMODIC TORTICOLLIS CHRONIC CLUSTER HEADACHE CHRONIC TENSION TYPE HEADACHE MIGRAINE WITH AURA, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS MIGRAINE WITH AURA, WITHOUT MENTION OF INTRACTABLE MIGRAINE WITH STATUS MIGRAINOSUS MIGRAINE WITH AURA, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS MIGRAINE WITHOUT AURA, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS MIGRAINE WITHOUT AURA, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS VARIANTS OF MIGRAINE, NOT ELSEWHERE CLASSIFIED, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS VARIANTS OF MIGRAINE, NOT ELSEWHERE CLASSIFIED, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS HEMIPLEGIC MIGRAINE, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS HEMIPLEGIC MIGRAINE, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS MENSTRUAL MIGRAINE, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS

8 FUTURE DRAFT Local Coverage Determination for Chemodenervation (DL31701) Page 8 of MENSTRUAL MIGRAINE, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS PERSISTENT MIGRAINE AURA WITHOUT CEREBRAL INFARCTION, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS PERSISTENT MIGRAINE AURA WITHOUT CEREBRAL INFARCTION, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS PERSISTENT MIGRAINE AURA WITH CEREBRAL INFARCTION, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS PERSISTENT MIGRAINE AURA WITH CEREBRAL INFARCTION, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS OTHER FORMS OF MIGRAINE, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS OTHER FORMS OF MIGRAINE, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS MIGRAINE, UNSPECIFIED, WITH INTRACTABLE MIGRAINE, SO STATED, WITHOUT MENTION OF STATUS MIGRAINOSUS MIGRAINE, UNSPECIFIED, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS MONOPLEGIA OF UPPER LIMB AFFECTING DOMINANT SIDE - MONOPLEGIA OF LOWER LIMB AFFECTING NONDOMINANT SIDE PARTIAL UNILATERAL PARALYSIS OF VOCAL CORDS PARTIAL BILATERAL PARALYSIS OF VOCAL CORDS LARYNGEAL SPASM TORTICOLLIS UNSPECIFIED DYSPHONIA CPT code 64614; HCPCS codes J0585, J0586, J0587, J GENETIC TORSION DYSTONIA ATHETOID CEREBRAL PALSY ACUTE DYSTONIA DUE TO DRUGS OTHER ACQUIRED TORSION DYSTONIA ORGANIC WRITERS' CRAMP

9 FUTURE DRAFT Local Coverage Determination for Chemodenervation (DL31701) Page 9 of OTHER FRAGMENTS OF TORSION DYSTONIA HEREDITARY SPASTIC PARAPLEGIA 340 MULTIPLE SCLEROSIS NEUROMYELITIS OPTICA - DEMYELINATING DISEASE OF CENTRAL NERVOUS SYSTEM UNSPECIFIED SPASTIC HEMIPLEGIA AND HEMIPARESIS AFFECTING UNSPECIFIED SIDE - SPASTIC HEMIPLEGIA AND HEMIPARESIS AFFECTING NONDOMINANT SIDE CONGENITAL DIPLEGIA - INFANTILE CEREBRAL PALSY UNSPECIFIED QUADRIPLEGIA UNSPECIFIED - UNSPECIFIED MONOPLEGIA MONOPLEGIA OF UPPER LIMB AFFECTING DOMINANT SIDE - MONOPLEGIA OF LOWER LIMB AFFECTING NONDOMINANT SIDE SPASM OF MUSCLE CRAMP OF LIMB CPT code 64650; HCPCS codes J0585, J0586, J0587, J PRIMARY FOCAL HYPERHIDROSIS CPT code 67345; HCPCS codes J0585, J0586, J0587, J ESOTROPIA UNSPECIFIED - UNSPECIFIED DISORDER OF EYE MOVEMENTS CPT codes ; HCPCS codes J CHRONIC MIGRAINE WITHOUT AURA, WITHOUT MENTION OF INTRACTABLE MIGRAINE WITHOUT MENTION OF STATUS MIGRAINOSUS - CHRONIC MIGRAINE WITHOUT AURA, WITH INTRACTABLE MIGRAINE, SO STATED, WITH STATUS MIGRAINOSUS Diagnoses that Support Medical Necessity ICD-9 Codes that DO NOT Support Medical Necessity All other ICD-9 codes not listed under "ICD-9 Codes that Support Medical Necessity" will be denied a medically necessary. ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation Diagnoses that DO NOT Support Medical Necessity Back to Top

10 FUTURE DRAFT Local Coverage Determination for Chemodenervation (DL31701) Page 10 of 14 General Information Documentations Requirements Documentation supporting the medical necessity should be legible, maintained in the patient's medical record, and must be made available to the A/B MAC upon request. Documentation to support medical necessity must be present for each date of service billed on the claim. Appendices Utilization Guidelines Chemodenervation treatment has a variable lasting beneficial effect from twelve to sixteen weeks, following which the procedure may need to be repeated. It is appropriate to inject the lowest clinically effective dose at the greatest feasible interval that results in the desired clinical result. Services performed for excessive frequency are not medically necessary. Frequency is considered excessive when services are performed more frequently than generally accepted by peers and the reason for additional services is not justified by documentation. See attached article for billing of OnabotulinumtoxinA for Detrusor Muscle Treatment Billing/Coding Guidelines. Sources of Information and Basis for Decision The development and coverage guidelines in this policy were based on a review of pertinent medical literature, policies from other Medicare contractors, and discussions with appropriate specialists. Assessment: The Clinical Usefulness Of Botulinum Toxin-A in Treating Neurological Disorders. Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 1990;40: Bielamowicz S et al. Effects of Botulinum Toxin on Pathophysiology in Spasmodic Dysphonia. Ann Otol Rhinol Laryngol 2000;109(2): Binder W et al. Botulinum Toxin Type A (BOTOX) for Treatment of Migraine Headaches: An Open Label Study. Otolaryngol Head Neck Surg 2000;123: Brashear A et al. Safety and Efficacy of Neurobloc (Botulinum Toxin Type B) in Type A Responsive Cervical Dystonia. Neurology 1999;22: Brin MF et al. Safety and Efficacy of Neurobloc (Botulinum Toxin Type B) in Type A Resistant Cervical Dystonia. Neurology 1999;53(7): Ceballos-Baumann AO. Evidenced Based Medicine in Botulinum Toxin Therapy for Cervical Dystonia. J Neurology 2001;248(Suppl 1): Cohen LG et al. Treatment of Focal Dystonias of the Hand with Botulinum Toxin Injections. J Neurology, Neurosurgery & Psychiatry 1989;52(3):

11 FUTURE DRAFT Local Coverage Determination for Chemodenervation (DL31701) Page 11 of 14 Comella C et al. Use of Botulinum Toxin Type A in the Treatment of Cervical Dystonia. Neurology 2000;55(12 Suppl 5):S Cullis PA et al. Botulinum Toxin Type B: An Open-Label Dose Escalation, Safety and Preliminary Efficacy Study in Cervical Dystonia Patients. Adv Neurology 1998;78: Heckman M et al. Botulinum Toxin A for Axillary Hyperhidrosis (Excessive Sweating). N Engl J Med 2001;344(7): Jankovic J et al. Therapeutic Uses of Botulinum Toxin. N Engl J Med 1991;324(17): Lew M et al. Botulinum Toxin Type B: A Double-Blind, Placebo-Controlled, Safety and Efficacy Study in Cervical Dystonia. Neurology 1997;49(3): Lew M et al. The Safety and Efficacy of Botulinum Toxin Type B in the Treatment of Patients with Cervical Dystonia: Summary of Three Controlled Clinical Trials. Neurology 2000;55(12 Suppl 5):S Maria G et al. A Comparison of Botulinum Toxin and Saline for the Treatment of Chronic Anal Fissure. N Engl J Med 1998;338: Naumann M et al. Botulinum Toxin Type a is a Safe and Effective Treatment for Axillary Hyperhidrosis Over 16 Months: A Prospective Study. Arch Dermatol 2003;139(6): Pasricha P et al. Intrasphincteric Botulinum Toxin for the Treatment of Achalasia. N Engl J Med 1995;322: Silberstein S et al. Botulinum Toxin Type A as a Migraine Preventive Treatment. For the BOTOX Migraine Clinical Research Group. Headache 2000;40: Tsui J et al. Botulinum Toxin Type B in the Treatment of Cervical Dystonia: A Pilot Study. Neurology 1995;45(11): Yoshimura D et al. Botulinum Toxin Therapy for Limb Dystonias. Neurology 1992;42: Advisory Committee Meeting Notes This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which include representatives from the affected provider community. Contractor Advisory Committee meeting dates: South Carolina -10/02/2012 North Carolina -10/02/0012 Virginia -10/02/2012 West Virginia 10/02/2012 Start Date of Comment Period 10/02/2012 End Date of Comment Period 11/16/2012 Start Date of Notice Period

12 FUTURE DRAFT Local Coverage Determination for Chemodenervation (DL31701) Page 12 of 14 Revision History Number Revision #11 Revision History Explanation Revision #11, 01/17/2013 Under CMS National Coverage Policy the following citations were added: Title XVIII of the Social Security Act, 1862 (a)(1)(a) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, Title XVIII of the Social Security Act, 1862 (a)(1)(d) No payment can be made for services that are to research or experimental and Title XVIII of the Social Security Act 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim. Under Indications and Limitations of Coverage and/or Medical Necessity added #11 for Chemodenervation of the parotid and submandibular salivary glands, bilaterally. Under CPT/HCPCS Codes added CPT code Under ICD-9 Codes That Support Medical Necessity section added ICD-9 code to be used with CPT code and HCPCS code J0587 for Chemodenervation of the parotid and submandibular salivary glands, bilateral. Under Documentation Requirements the verbiage was re-written. Utilization Guidelines added verbiage to direct providers to the attached article for billing/coding of OnabotulinumtoxinA for Detrusor Muscle. Annual review completed. Due to the addition of the CPT code, this LCD is going out for comment starting 10/02/ /16/2012. This revision becomes effective on 01/17/ /01/2012 Revision Effective Date for approved reconsideration request: Services performed on or after 06/01/2012 Indications and Limitations of Coverage Section Added the following text: 10. Chemodenervation of the detrusor urinae muscle for the treatment of overactivity associated with a neurologic condition in adults with an inadequate response to anticholinergic treatment 9 01/01/2012 Revision Effective Date: Services performed on or after 01/01/2012 Per approved reconsideration request to separate and specify J0585 FDA approved indications Grp 8 created and I-9 codes removed from Grps 3-4. Added: CPT codes ; HCPCS codes J0585 (Grp 8) Added I-9 codes: CPT code 64612; HCPCS codes J0585, J0586, J0587, J0588 (Grp 3) Removed codes: CPT code 64613; HCPCS codes J0585, J0586, J0587, J0588 (Grp 4) Removed codes: /01/2012 Revision Effective Date: Services performed on or after 01/01/ CPT code update Replaced temporary code Q2040 with permanent code J0588 7

13 FUTURE DRAFT Local Coverage Determination for Chemodenervation (DL31701) Page 13 of 14 10/01/2011 Revision Effective Date: Services performed on or after 10/01/ /2011 ICD-9-CM code update applied. CPT code 64612; HCPCS codes J0585, J0586, J0587, Q2040(Grp 3) and CPT code 64613; HCPCS codes J0585, J0586, J0587, Q2040(Grp 4) Revised descriptions: /01/2011 Revision Effective Date: Services performed on or after 10/01/2011 CPT code 64612; HCPCS codes J0585, J0586, J0587, Q2040 (Grp 3) and CPT code 64613; HCPCS codes J0585, J0586, J0587, Q2040(Grp 4) Add: , CPT code 64614; HCPCS codes J0585, J0586, J0587, Q2040(Grp 5) Add: CPT code 64614; HCPCS codes J0585, J0586, J0587, Q2040(Grp 5) Add , /01/2011 Revision Effective Date: Services performed on or after 07/01/2011 July 2011 HCPCS update added Q Injection, Incobotulinumtoxin A, 1 Unit to CPT/HCPCS list-database update complete. 4 07/01/2011 Revision Effective Date: Services performed on or after 07/01/2011 July 2011 HCPCS update added Q Injection, Incobotulinumtoxin A, 1 Unit. Replaced NOC J3590 for Injection, Incobotulinumtoxin A. Since MCDB updates will not be completed until 01/01/2012, information added to Paragraph Grp 2 text. removed J3590 from Grp 1-7 and replaced with Q2040 Q Injection, Incobotulinumtoxin A, 1 Unit 3 06/18/2011 Revision Effective Date: Services performed on or after 06/18/2011 Per scheduled J11 implementation, LCD added to South Carolina #11202 and West Virginia # /28/2011 Revision Effective Date: Services performed on or after 05/28/2011 Per scheduled J11 implementation, LCD added to North Carolina MAC# /19/2011 Effective Date: 3/19/2011 In accordance with the Medicare Modernization Act of 2003, LCD# L21803 from Carrier# has been selected for the J11 implementation.

14 FUTURE DRAFT Local Coverage Determination for Chemodenervation (DL31701) Page 14 of 14 11/21/ The following CPT/HCPCS codes were deleted: Q2040 was deleted from Group 2 Reason for Change Coverage Change (actual change in medical parameters) HCPCS Addition/Deletion Maintenance (annual review with new changes, formatting, etc.) Other Related Documents Article(s) A LCD Chemodenervation Article: OnabotulinumtoxinA for Detrusor Muscle Treatment Billing/Coding Guidelines LCD Attachments There are no attachments for this LCD. Draft Contact Fatimah Jah-Ndiaye, MD PO Box Columbia, AL Fatimah.Jah-Ndiaye@PalmettoGBA.com Back to Top All Versions Updated on 09/07/2012 with effective dates 01/17/ N/A Read the LCD Disclaimer Back to Top Department of Health & Human Services Medicare.gov USA.gov Web Policies & Important Links Privacy Policy Freedom of Information Act No Fear Act Centers for Medicare & Medicaid Services, 7500 Security Boulevard Baltimore, MD

15 FUTURE DRAFT Local Coverage Determination for HbA1c (DL32939) Page 1 of 8 Home Medicare Medicaid CHIP About CMS Regulations & Guidance Research, Statistics, Data & Systems Outreach & E People with Medicare & Medicaid Questions Careers Newsroom Contact CMS Acronyms Help Back to Local Coverage Determinations (LCDs) for Palmetto GBA (11502, MAC - Part B) FUTURE DRAFT Local Coverage Determination (LCD) for HbA1c (DL32939) Select the Print Record, Add to Basket or Record buttons to print the record, to add it to your basket or to the record. Section Navigation Select Section Go Please note: This is a Draft policy. Draft LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Draft LCDs are not necessarily a reflection of the current policies or practices of the contractor. Please note: This is a Future Draft LCD. Contractor Information Contractor Name Palmetto GBA Contractor Number Contractor Type MAC - Part B Back to Top

16 FUTURE DRAFT Local Coverage Determination for HbA1c (DL32939) Page 2 of 8 LCD Information Document Information LCD ID Number DL32939 LCD Title HbA1c Contractor's Determination Number J11B L AMA CPT/ADA CDT Copyright Statement CPT only copyright American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association. Primary Geographic Jurisdiction North Carolina Oversight Region Region IV Original Determination Effective Date For services performed on or after 01/17/2013 Original Determination Ending Date Revision Effective Date Revision Ending Date CMS National Coverage Policy Title XVIII of the Social Security Act (SSA), 1862(a)(1)(A), states that no Medicare payment shall be made for items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Title XVIII of the Social Security Act, 1833(e), prohibits Medicare payment for any claim lacking the necessary documentation to process the claim.

17 FUTURE DRAFT Local Coverage Determination for HbA1c (DL32939) Page 3 of 8 42 Code of Federal Regulations (CFR) indicates that diagnostic tests are payable only when ordered by the physician who is treating the beneficiary for a specific medical problem and who uses the results in such treatment. CMS Manual System, Publication , National Coverage Determinations Manual, Chapter 1, Part 3, Glycated Hemoglobin/Glycated Protein CMS Manual System, Publication , Medicare Program Integrity Manual, Chapter 3, , Diagnosis Code Requirement Indications and Limitations of Coverage and/or Medical Necessity Hemoglobin A1c (HbA1c) refers to the major component of hemoglobin A1, usually determined by ion-exchange affinity chromatography, immunoassay or agar gel electrophoresis. HbA1c assesses glycemic control over a period of 4-8 weeks and appears to be the more appropriate test for monitoring a diabetic patient who is capable of maintaining long term, stable control. Measurement may be medically necessary every 3 months to determine whether a patient's metabolic control has been. on average, within the target range. More frequent assessments, every 1-2 months, may be appropriate in the patient whose diabetes regimen has been altered to improve control or in whom evidence is present that intercurrent events may have altered a previously satisfactory level of control (for example, post-major surgery, severe hypoglycemia or ketoacidosis, or as a result of glucocorticoid or other therapy). HbA1c is widely accepted as medically necessary for the management and control of patients with diabetes. It is also valuable to assess hyperglycemia, a history of hyperglycemia or dangerous hypoglycemia. It is not considered reasonable and necessary to perform HbA1c tests more often than once every three months on a controlled diabetic patient to determine whether the patient's metabolic control has been, on average, within the target range. It is not considered reasonable and necessary for these tests to be performed more frequently than once a month for diabetic pregnant women. Testing for uncontrolled type one or type two diabetes mellitus (or other causes of severe hyper or hypoglycemia) may require testing more than four times a year. We will allow one additional HbA1c test every three months for a total of 8 tests per year in patients with uncontrolled blood glucose levels. Additional tests beyond that frequency may be reimbursed on appeal with appropriate documentation of medical necessity. HbA1c may be inaccurate in certain situations including anemia, transfusions, hemoglobinopathies and conditions of rapid red cell turnover. Other tests to assess diabetes, including glucose, glycated protein, or fructosamine levels, may be used and are described in the Lab National Coverage Decision (NCD for Glycated Hemoglobin / Glycated Protein). This NCD lists the ICD-9 codes for HbA1c for frequencies up to once every three months. The ICD-9-CM codes for test frequencies exceeding one every 90 days are listed below. Back to Top

18 FUTURE DRAFT Local Coverage Determination for HbA1c (DL32939) Page 4 of 8 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 policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims. 999x Not Applicable 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 policy 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 policy should be assumed to apply equally to all Revenue Codes. CPT/HCPCS Codes HEMOGLOBIN; GLYCOSYLATED (A1C) ICD-9 Codes that Support Medical Necessity ICD-9-CM codes for performing tests at frequencies more than every 90 days SECONDARY DIABETES MELLITUS WITHOUT MENTION OF COMPLICATION, SECONDARY DIABETES MELLITUS WITH KETOACIDOSIS, SECONDARY DIABETES MELLITUS WITH HYPEROSMOLARITY, SECONDARY DIABETES MELLITUS WITH OTHER COMA, SECONDARY DIABETES MELLITUS WITH RENAL MANIFESTATIONS,

19 FUTURE DRAFT Local Coverage Determination for HbA1c (DL32939) Page 5 of SECONDARY DIABETES MELLITUS WITH OPHTHALMIC MANIFESTATIONS, SECONDARY DIABETES MELLITUS WITH NEUROLOGICAL MANIFESTATIONS, SECONDARY DIABETES MELLITUS WITH PERIPHERAL CIRCULATORY DISORDERS, SECONDARY DIABETES MELLITUS WITH OTHER SPECIFIED MANIFESTATIONS, DIABETES MELLITUS WITHOUT MENTION OF COMPLICATION, TYPE II OR UNSPECIFIED TYPE, DIABETES MELLITUS WITHOUT MENTION OF COMPLICATION, TYPE I [JUVENILE TYPE], DIABETES WITH KETOACIDOSIS, TYPE II OR UNSPECIFIED TYPE, DIABETES WITH KETOACIDOSIS, TYPE I [JUVENILE TYPE], DIABETES WITH HYPEROSMOLARITY, TYPE II OR UNSPECIFIED TYPE, DIABETES WITH HYPEROSMOLARITY, TYPE I [JUVENILE TYPE], DIABETES WITH OTHER COMA, TYPE II OR UNSPECIFIED TYPE, DIABETES WITH OTHER COMA, TYPE I [JUVENILE TYPE], DIABETES WITH RENAL MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, DIABETES WITH RENAL MANIFESTATIONS, TYPE I [JUVENILE TYPE], DIABETES WITH OPHTHALMIC MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, DIABETES WITH OPHTHALMIC MANIFESTATIONS, TYPE I [JUVENILE TYPE], DIABETES WITH NEUROLOGICAL MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, DIABETES WITH NEUROLOGICAL MANIFESTATIONS, TYPE I [JUVENILE TYPE],

20 FUTURE DRAFT Local Coverage Determination for HbA1c (DL32939) Page 6 of DIABETES WITH PERIPHERAL CIRCULATORY DISORDERS, TYPE II OR UNSPECIFIED TYPE, DIABETES WITH PERIPHERAL CIRCULATORY DISORDERS, TYPE I [JUVENILE TYPE], DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE I [JUVENILE TYPE], DIABETES WITH UNSPECIFIED COMPLICATION, TYPE II OR UNSPECIFIED TYPE, DIABETES WITH UNSPECIFIED COMPLICATION, TYPE I [JUVENILE TYPE], HYPOGLYCEMIC COMA OTHER SPECIFIED HYPOGLYCEMIA POSTSURGICAL HYPOINSULINEMIA ICD-9-CM related to pregnancy and can be covered no more frequently than once per month DIABETES MELLITUS OF MOTHER COMPLICATING PREGNANCY CHILDBIRTH OR THE PUERPERIUM UNSPECIFIED AS TO EPISODE OF CARE - ABNORMAL GLUCOSE TOLERANCE OF MOTHER POSTPARTUM Diagnoses that Support Medical Necessity ICD-9 Codes that DO NOT Support Medical Necessity All ICD-9-CM codes not listed in this policy under ICD-9-CM Codes That Support Medical Ne ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation Diagnoses that DO NOT Support Medical Necessity All ICD-9-CM codes not listed in this policy under ICD-9-CM Codes That Support Medical Necessity above. Back to Top General Information

21 FUTURE DRAFT Local Coverage Determination for HbA1c (DL32939) Page 7 of 8 Documentations Requirements Documentation supporting medical necessity should be legible, maintained in the patient's medical record, and must be made available to the A/B MAC upon request. When the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary. The HCPCS/CPT code(s) may be subject to Correct Coding Initiative (CCI) edits. This policy does not take precedence over CCI edits. Please refer to the CCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare. When requesting a written redetermination (formerly appeal), providers must include all relevant documentation with the request. Appendices N/A Utilization Guidelines A. One additional test for Diabetes Mellitus out of control (Group 2). B. Up to one monthly test for pregnant Type I diabetic patients (Group 3). Sources of Information and Basis for Decision National Academy of Clinical Biochemistry (NACB). Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Washington (DC): National Academy of Clinical Biochemistry (NACB, 2011; 104 p. National Coverage Determination for Glycated Hemoglobin/Glycated Protein (190.21) CR2130, Transmittal 17 National Guideline Clearinghouse Standards for medical care in diabetes V. Diabetes Care. Diabetes Care, Jan 2011;34(Suppl1):S16-28 Wisconsin diabetes mellitus essential care guidelines. Wisconsin Diabetes Prevention and Control Program, Madison, WI: 2011;various pages. Tests of Glycemia in Diabetes. Diabetes Care. Jan 2002;25, S1:S97-S99. Advisory Committee Meeting Notes This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which include representatives from the affected provider community. Contractor Advisory Committee meeting dates: North Carolina - 10/02/2012 South Carolina - 10/02/2012

22 FUTURE DRAFT Local Coverage Determination for HbA1c (DL32939) Page 8 of 8 Virginia - 10/02/2012 West Virginia - 10/02/2012 Start Date of Comment Period 10/02/2012 End Date of Comment Period 11/16/2012 Start Date of Notice Period Revision History Number Revision History Explanation Reason for Change Other Related Documents This LCD has no Related Documents. LCD Attachments There are no attachments for this LCD. Draft Contact Fatimah Jah-Ndiaye, MD PO Box Columbia, AL Fatimah.Jah-Ndiaye@PalmettoGBA.com Back to Top All Versions Updated on 09/06/2012 with effective dates 01/17/ N/A Read the LCD Disclaimer Back to Top Department of Health & Human Services Medicare.gov USA.gov Web Policies & Important Links Privacy Policy Freedom of Information Act No Fear Act Centers for Medicare & Medicaid Services, 7500 Security Boulevard Baltimore, MD

23 FUTURE DRAFT Local Coverage Determination for Ophthalmology: Posterior Segment... Page 1 of 34 Home Medicare Medicaid CHIP About CMS Regulations & Guidance Research, Statistics, Data & Systems Outreach & E People with Medicare & Medicaid Questions Careers Newsroom Contact CMS Acronyms Help Back to Local Coverage Determinations (LCDs) for Palmetto GBA (11502, MAC - Part B) FUTURE DRAFT Local Coverage Determination (LCD) for Ophthalmology: Posterior Segment Imaging (Extended Ophthalmoscopy and Fundus Photography) (DL32953) Select the Print Record, Add to Basket or Record buttons to print the record, to add it to your basket or to the record. Section Navigation Select Section Go Please note: This is a Draft policy. Draft LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Draft LCDs are not necessarily a reflection of the current policies or practices of the contractor. Please note: This is a Future Draft LCD. Contractor Information Contractor Name Palmetto GBA Contractor Number Contractor Type MAC - Part B Back to Top

24 FUTURE DRAFT Local Coverage Determination for Ophthalmology: Posterior Segment... Page 2 of 34 LCD Information Document Information LCD ID Number DL32953 LCD Title Ophthalmology: Posterior Segment Imaging (Extended Ophthalmoscopy and Fundus Photography) Contractor's Determination Number J11B L AMA CPT/ADA CDT Copyright Statement CPT only copyright American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association. Primary Geographic Jurisdiction North Carolina Oversight Region Region IV Original Determination Effective Date For services performed on or after 01/17/2013 Original Determination Ending Date Revision Effective Date Revision Ending Date CMS National Coverage Policy Language quoted from the Centers for Medicare and Medicaid Services (CMS) National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR [b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See 1869(f)(1)(A)(i) of the

25 FUTURE DRAFT Local Coverage Determination for Ophthalmology: Posterior Segment... Page 3 of 34 Social Security Act. Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: Title XVIII of the Social Security Act, 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Title XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim. Title XVIII of the Social Security Act, 1862(a)(7) excludes routine physical examinations. 42 CFR indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements). CMS Manual System, Pub , Medicare Benefit Policy Manual, Chapter 15, Glaucoma Screening CMS Manual System, Pub , Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 1, 80.6 Intraocular Photography CMS Manual System, Pub , Medicare Claims Processing Manual, Chapter 12, 40.1.A Components of a Global Surgical Package CMS Manual System, Pub , Medicare Claims Processing Manual, Chapter 18, Glaucoma Screening Services Indications and Limitations of Coverage and/or Medical Necessity 1. Abstract: Fundus photography Fundus photography Fundus photography involves the use of a retinal camera to photograph the regions of the vitreous, retina, choroid and optic nerve. Extended ophthalmoscopy Extended ophthalmoscopy is the detailed examination of the retina with drawing. It is most frequently performed utilizing an indirect lens, although it may be performed using contact lens biomicroscopy. It may use scleral depression. It is performed by the physician, when a more detailed examination (including that of the periphery) is needed following routine ophthalmoscopy. It is usually performed with the pupil dilated and always includes a true drawing of the retina (macula, fundus and periphery) with interpretation and report. The examination must be used for medical decision making. 2. Indications:

26 FUTURE DRAFT Local Coverage Determination for Ophthalmology: Posterior Segment... Page 4 of 34 Fundus photography Fundus photography may be indicated to document abnormalities of disease processes affecting the eye, or to follow the progress of such disease. In order to document a disease process or follow the progress of a disease, photographs and an interpretation and report of the test may be necessary. Photographs and an interpretation and report of the test may also be necessary to plan treatment for a disease process. Fundus photography may be used for the diagnosis of conditions such as macular degeneration, retinal neoplasms, choroid disturbances and diabetic retinopathy, glaucoma, multiple sclerosis or other central nervous system anomalies. Extended ophthalmoscopy Extended ophthalmoscopy is indicated when the level of examination requires a complete view of the posterior segment of the eye and documentation is greater than that required for general ophthalmoscopy. An extended ophthalmoscopy may be considered medically reasonable and necessary for the following conditions: a. Malignant neoplasm of the retina or choroid. b. Retained (old) intraocular foreign body, either magnetic or-signs and symptoms may include a statement by the patient that something has hit his/her eye (foreign body sensation), normal or blurred vision, pain or no discomfort, and tearing. c. Retinal hemorrhage, edema, ischemia, exudates and deposits, hereditary retinal dystrophies or peripheral retinal degeneration. d. Retinal detachment with or without retinal defect-the patient may complain of light flashes, dark floating specks, and blurred vision that becomes progressively worse. This may be described by the patient as "a curtain came down over my eyes." e. Symptoms suggestive of retinal defect (ex: flashes and/or floaters) f. Retinal defects without retinal detachment g. Diabetic retinopathy (i.e., background retinopathy or proliferative retinopathy), retinal vascular occlusion, or separation of the retinal layers-this may be evidenced by microaneurysms, cotton wool spots, exudates, hemorrhages, or fibrous proliferation. h. Experienced sudden visual loss or transient visual loss i. Chorioretinitis, chorioretinal scars or choroidal degeneration, dystrophies, hemorrhage and rupture, or detachment j.sustained penetrating wound to the orbit resulting in the retention of a foreign body in the eye

27 FUTURE DRAFT Local Coverage Determination for Ophthalmology: Posterior Segment... Page 5 of 34 k.sustained a blunt injury to the eye or adnexa l. Disorders of the vitreous body (i.e., vitreous hemorrhage or posterior vitreous detachment)- spots before the eyes (floaters) and flashing lights (photopsia) can be signs/symptoms of these disorders m. Posterior scleritis-signs and symptoms may include severe pain and inflammation, proptosis, limited ocular movements, and a loss of a portion of the visual field n. Vogt-Koyanagi-Harady syndrome-a condition characterized by bilateral uveitis, dysacousia, meningeal irritation, whitening of patches of hair (poliosis), vitiligo, and retinal detachment. The disease can be initiated by a severe headache, deep orbital pain, vertigo, and nausea o.degenerative disorders of the globe p. Retinoschisis and retinal cysts. Patients may complain of light flashes and floaters q.signs and symptoms of endophthalmitis, which may include severe pain, redness, photophobia, and profound loss of vision r.glaucoma or is a glaucoma suspect-this may be evidenced by increased intraocular pressure or progressive cupping of the optic nerve s.systemic disorders which may be associated with retinal pathology t.high axial length myopia u.retinal edema v.metamorphopsia w.high-risk medication for retinopathy or optic neuropathy x.choroidal nevus being evaluated for malignant transformation y.macular degeneration Fundus photography and Extended ophthalmoscopy CPT code (remote imaging for detection of retinal disease, e.g. retinopathy in a patient with diabetes, with analysis and report under physician supervision, unilateral or bilateral) is not for routine screening, but is covered for evaluation of asymptomatic patients at risk with known disease (e.g. diabetes mellitus) that is likely to cause retinal disease. CPT code (remote imaging for monitoring and management of active retinal disease, e.g. diabetic retinopathy, with physician review, interpretation and report, unilateral or bilateral) is a covered service.