Local Coverage Determination (LCD): Vitamin B 12 Injections (L30145) Contractor Information

Local Coverage Determination (LCD): Vitamin B 12 Injections (L30145) Contractor Information Contractor Name Wisconsin Physicians Service Insurance Corporation Document Information LCD ID L30145 LCD Title Vitamin B 12 Injections Original Effective Date For services performed on or after 09/15/2009 AMA CPT/ADA CDT Copyright Statement CPT only copyright 2002-2012 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. Revision Effective Date For services performed on or after 10/01/2013 Revision Ending Date Retirement Date Notice Period Start Date 06/01/2012 Notice Period End Date CMS National Coverage Policy Jurisdiction "8" Notice: Jurisdiction "8" comprises the states of Indiana and Michigan. WPS is responsible for claims payment and Local Coverage Determination (LCD) development for this jurisdiction. This LCD was created as a part of the legacy transition (7/16/2012-8/20/2012); and, is a consolidation of the previous legacy contractors policies. Coverage of each LCD begins when the state/contract number combination officially is integrated into the

Jurisdiction. On the CMS MCD, this date is known as either the Original Effective Date or the Revision Effective Date. The following table details the official effective dates for each state/contract number combination. ST Legacy A Legacy B J "8" MAC A J "8" MAC B J "8" Contractor Contractor Contractor Contractor Effective & & & & Date Contract Number Contract Number Contract Number Contract Number IN NGS: 00630 WPS: 08102 08/20/12 MI WPS: 00953 WPS: 08202 07/16/12 IN NGS: 00130 WPS: 08101 07/23/12 MI NGS: 00452 WPS: 08201 07/23/12 Title XVIII of the Social Security Act section 1862 (a)(1)(a). This section allows coverage and payment of those services that are considered to be medically reasonable and necessary. Title XVIII of the Social Security Act section 1862 (a)(7). This section excludes routine physical examinations and services Title XVIII of the Social Security Act section 1833 (e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim. CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 6, Section 20.4.4 Coverage of Outpatient Diagnostic Services. CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 8, Section 50.5 Drugs and Biologicals. CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 13, Section 60.7 Coverage of Services and Supplies. CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50 Drugs and Biologicals 50.1Definition of Drug or Biological 50.2 Determining Self-Administration of Drug or Biological 50.3 Incident-to requirements, 50.4.1 Approved Use of Drug 50.4.3 Examples of Not reasonable and necessary CMS Publication 100-3, Medicare National Coverage Determinations(NCD) Manual, Chapter 1, Section 150.6 Vitamin B12 Injections to Strengthen Tendons, Ligaments, etc., of the Foot. CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 25, Section 75.5, Form Locators 44. CMS Publication 100-04 Medicare Claims Processing Manual, Chapter 18, Section 10.2 Billing Requirements. CMS Publication 100-08, Medicare Program Integrity manual, Transmittal 63, dated January 23, 2004, CR # 3010.

Coverage Guidance Coverage Indications, Limitations, and/or Medical Necessity LCD Description Vitamin B12 (cyanocobalamin, B12) is an essential vitamin necessary for cell maturation and neurologic function. B12 deficiency may be caused by several pathological and post-surgical conditions and its presence can be assessed by B12 serum assays. This deficiency can lead to profound hematological and neurological damage, and may be corrected by oral B12, intranasal B12 gel, or intramuscular or deep subcutaneous injection. Oral replacement of vitamin B12 is the treatment of choice in most cases of deficiency. Oral administration of vitamin B12 is as effective as parenteral administration in treating deficiency in most cases. This policy will cover only the intramuscular or deep subcutaneous injection of B12 since the other two modes of replacement are both self-administered and so are not Medicare benefits. However, if the B12 deficiency can be adequately treated by other than parenteral means it would not be considered appropriate to bill Medicare for injectable B12. This policy will briefly discuss certain tests used to determine the cause of the B12 deficiency, but the policy s focus will be on the injection of B12 to correct the deficiency from whatever cause. Indications and Limitations of Coverage and/or Medical Necessity 1. Generally, the indication for Vitamin B12 injection that justifies medical necessity is Vitamin B12 deficiency not corrected by oral dosing. While B12 deficiency has many causes, few of these causes will always lead to B12 deficiency. Accordingly, the physician should not give B12 just because the patient has one of the causes, but only after a deficiency has been documented by serum assay. Serum assay is a reliable initial screening test, although it does not reflect tissue status. B12 levels below 100pg/mL suggest deficiency, but discriminate poorly between 100-400pg/mL. Test results in this range may require further testing. Tests to consider include serum homocysteine, serum methylmalonic acid (MMA), and serum HoloTC-II (active vitamin B12) assays (Dharmarajan, et al.). Two causes that are exceptions to this statement are total gastrectomy and total ileal resection, both leading to B12 deficiency. 2. The normal range of serum B12 is 200 to 900 pg/ml (Harrison's). However, the Laboratory Test Handbook states that "The lower reference limit, which is critical to the diagnosis of B12 deficiency/pernicious anemia, is not clearly established. It is likely in the range of 100-250 pg/ml." Further, Harrison s states that "Serum methylmalonic acid and homocysteine levels are elevated in cobalamin deficiency These tests measure tissue vitamin stores and may demonstrate a deficiency even when the more traditional but less reliable folate and cobalamin levels are borderline or even normal. Patients (particularly older patients) without anemia and with normal serum cobalamin levels but elevated levels of serum methylmalonic acid may develop neuropsychiatric abnormalities. Treatment of patients with this "subtle" cobalamin deficiency will usually prevent further deterioration and may result in improvement." But note that neither serum methylmalonic acid (MMA) nor serum homocysteine tests are listed in the AMA's CPT manual, and neither is inexpensive. Accordingly, when a patient shows neuropsychiatric abnormalities, and the serum B12 is low normal, i.e., below 350 pg/ml, the physician may, in the absence of methylmalonic acid or homocysteine tests, presume a B12 deficiency and treat the patient with B12. Likewise if MMA and /or homocysteine level (s) are available it is also appropriate to justify treatment if these levels are abnormal. There are exceptions to the above. a. Since adequate absorption of dietary B12 requires a functioning stomach and ileum, complete surgical resection of either the stomach or ileum can be presumed to always lead to B12 deficiency, and that diagnosis may be presumed without a serum B12 assay and that parenteral B12 is required in these instances. b. Utilization of certain chemotherapy drugs (e.g. Pemetrexed Disodium [Alimta TM ]) can result in depletion of Vitamin B-12. Prophylactic use of parenteral Vitamin B12 is covered in this instance.

3. Medicare does not cover therapy to achieve supranormal B12 levels. Other Comments Limitation of liability and refund requirements apply when denials are likely, whether based on medical necessity or other coverage reasons. The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item, or procedure may not be covered by Medicare. The limitation and refund requirements do not apply when the test, item, or procedure is statutorily excluded, has no Medicare benefit category or is rendered for screening purposes. Notice to beneficiaries related to discharge and coverage notification, as described in CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 2 sections 80-80.2, applies. Hospitals have been instructed to provide Hospital-Issued Notices of Noncoverage (HINNs) to beneficiaries prior to admission, at admission, or at any time during an inpatient stay if the hospital determines that the care the beneficiary is receiving, or is about to receive, is not covered because if it not medically necessary, not delivered in the most appropriate setting, or is custodial in nature. 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. 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. Revenue codes only apply to providers who bill these services to the fiscal intermediary or MAC Part A. Revenue codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or MAC Part B. 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. 0250 Pharmacy - General Classification 0260 IV Therapy - General Classification 028X Oncology - General Classification 0636 Pharmacy - Drugs Requiring Detailed Coding CPT/HCPCS Codes Group 1 Paragraph: Group 1 Codes: J3420 INJECTION, VITAMIN B-12 CYANOCOBALAMIN, UP TO 1000 MCG

ICD-9 Codes that Support Medical Necessity Group 1 Paragraph: Note: ICD-9 codes must be coded to the highest level of specificity. The correct use of an ICD-9 code listed below does not assure coverage of this service. The service must be reasonable and necessary in the specific case and must meet the criteria specified in this determination. Group 1 Codes: 266.2 OTHER B-COMPLEX DEFICIENCIES 281.0 PERNICIOUS ANEMIA 281.1 OTHER VITAMIN B12 DEFICIENCY ANEMIA 281.3 OTHER SPECIFIED MEGALOBLASTIC ANEMIAS NOT ELSEWHERE CLASSIFIED 564.2 POSTGASTRIC SURGERY SYNDROMES 579.3 OTHER AND UNSPECIFIED POSTSURGICAL NONABSORPTION V07.39 NEED FOR OTHER PROPHYLACTIC CHEMOTHERAPY V45.3 POSTSURGICAL INTESTINAL BYPASS OR ANASTOMOSIS STATUS V45.75 ACQUIRED ABSENCE OF ORGAN STOMACH V58.49 OTHER SPECIFIED AFTERCARE FOLLOWING SURGERY V58.69 LONG-TERM (CURRENT) USE OF OTHER MEDICATIONS ICD-9 Codes that DO NOT Support Medical Necessity Associated Information Documentation Requirements 1. Documentation supporting the medical necessity of this item, such as ICD-9 codes, must be submitted with each claim. Claims submitted without such evidence will be denied as being not medically necessary. 2. The patient s medical record must contain documentation that fully supports the medical necessity for services included within this LCD (See Indications and Limitations of Coverage and/or Medical Necessity ). This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. This documentation, if requested, must be made available upon request to the Fiscal Intermediary, Carrier, or MAC Part A or B. 3. Documentation in the medical record should support the need for injectable B12. The medical record must be made available to Medicare upon request. Utilization Guidelines 1. Typical dosing is once monthly with the adult maintenance dose typically ranging from 100-1,000 micrograms. Initial injections may be more frequent until a steady level is reached. Higher frequency will require special medical circumstances that justify additional injections and may be subject to review. 2. Vitamin B12 injections to strengthen tendons, ligaments, etc., of the foot are not covered under Medicare because (1) there is no evidence that vitamin B12 injections are effective for the purpose of strengthening weakened tendons and ligaments, and (2) this is nonsurgical treatment under the subluxation exclusion.

Accordingly, vitamin B12 injections are not considered reasonable and necessary within the meaning of 1862(a)(1) of the Act and (CMS Publication 100-3, Medicare National Coverage Determinations Manual, Chapter 1, Section 150.6). Sources of Information and Basis for Decision AHFS Drug Information, 2001, p. 3511, American Hospital Formulary Service, Bethesda, MD, 2001 Andres Emmanuel, Loukili Noureddine H, Noel Esther, et al. (2004) Vitamin B12 (Cobalamine) deficiency in elderly patients. Canadian Medical Association Journal. 171(3): 251-259. BCHealthServices, (2003). Guidelines and Protocols Advisory Committee, retrieved on February 16, 2009 from http://www.hlth/gov.bc.ca/msp/protoguides/gps/index.html Braunwald, et al, eds. Harrison's Principles of Internal Medicine, New York: McGraw Hill, 2001, p. 680 Dharmarajan, TS, Adiga, GU, Norkus, E. (2003). Vitamin B12 deficiency; recognizing subtle symptoms in older adults, Geriatrics. (58) 3. Jacobs et al, eds, Laboratory Test Handbook, 4th Edition, Cleveland, LEXI-COMP INC, 1996. Other carriers' LCDs USP DI 2001, Vol 1, p. 3015, Micromedex, Englewood, Colorado, 2001 Carrier Advisory Committee (CAC) Meeting Dates Illinois 05/13/2009 Michigan 06/06/2009 Minnesota 05/21/2009 Wisconsin 05/15/2009 J5 MAC 06/04/2009 Jurisdictional Open Meeting 04/15/2009 Start Date of Comment Period 06/04/2009, End Date of Comment Period 07/20/2009 Revision History Information Please note: The Revision History information included in this LCD prior to 1/24/2013 will now display with a Revision History Number of "R1" at the bottom of this table. All new Revision History information entries completed on or after 1/24/2013 will display as a row in the Revision History section of the LCD and numbering will begin with "R2". Revision History Date Revision History Number Revision History Explanation Reason(s) for Change 10/01/2013 R3 10/01/2013 replaced documentation requirements, utilization Other guidelines and CAC information that were removed with format change. 09/07/2013 R2 The WPS Carrier Contract Numbers 00951(WI), 00952(IL), and 00954(MN) were removed from this LCD. Effective 09/07/2013, the Jurisdiction 6 Part B MAC contractor for Illinois, Wisconsin, and Minnesota is National Government Change in Assigned States or Affiliated Contract Numbers

Services (NGS). 10/22/2012 R1 01/16/2013 Annual review no change in coverage. Maintenance (annual review with now 10/22/2012: In accordance with Section 911 of the Medicare Modernization Act of 2003 and CMS Change Request 8059, changes, formatting, etc) contractor numbers in this LCD policy were updated due to the Change in Assigned transition from WPS Fiscal Intermediary Contract Number 52280 to WPS Part A MAC Contractor Number 05901. No States or Affiliated Contract Numbers other changes were made to this LCD policy. 08/20/2012: This LCD was revised to add the Jurisdiction 8 (J- 8) Indiana Part B MAC Contract Number 08102. The CMS Statement of Work for the J8 Medicare Administrative Contract (MAC) requires that the contractor retain the most clinically appropriate LCD within the jurisdiction. This WPS policy is being promulgated to the J8 MAC as the most clinically appropriate LCD within this jurisdiction. No coverage changes were made to this LCD for this revision. 07/23/2012: This LCD was revised to add the Jurisdiction 8 (J- 8) Indiana and Michigan Part A MAC Contract Numbers 08101 and 08201. The CMS Statement of Work for the J8 Medicare Administrative Contract (MAC) requires that the contractor retain the most clinically appropriate LCD within the jurisdiction. This WPS policy is being promulgated to the J8 MAC as the most clinically appropriate LCD within this jurisdiction. No coverage changes were made to this LCD for this revision. 07/16/2012: This LCD was revised to add the Jurisdiction 8 (J- 8) Michigan Part B MAC Contract Number 08202 and remove the legacy Michigan Part B Carrier Contract Number 00953. The CMS Statement of Work for the J8 Medicare Administrative Contract (MAC) requires that the contractor retain the most clinically appropriate LCD within the

jurisdiction. This WPS policy is being promulgated to the J8 MAC as the most clinically appropriate LCD within this jurisdiction. No coverage changes were made to this LCD for this revision. 12/01/2009: Revision to ICD-9 coding. Added codes V07.39 and V58.69 deleted V67.51. Revision based on correction of coding for prophylactic B-12 injection use for certain chemotherapy drugs that are B-12 deleting medications. Providers notified on the WPS website on 01/01/2010 and in the March 2010 Quarterly Communique. 10/22/2009: Revision to indications and limitations section of policy for increased clarity for B-12 utilization with chemotherapy drugs; revised to read (e.g. Pemetrexed Disodium (Alimta TM ). Revision history effective 12/01/2009, this change does not affect claims processing. Providers notified in the December 2009 Communique. Removed contractor number 05392 E MO. This number is being joined with W MO to include all of MO under one contractor number effective 8/01/2009. 08/01/2009: final comments document attached, finalized draft policy for notice period and updated contractor code listing and Advisory Committee dates table. 04/02/2009 Approved 04/02/2009 Added as new draft LCD. AB 04/19/2010 In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of American Somoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands were removed from this LCD because claims processing for those states are transitioning from FI

Contractor Wisconsin Physician Services (WPS - 52280) to MAC Part A Contractor Palmetto. 8/1/2010 - The description for Revenue code 0250 was changed 8/1/2010 - The description for Revenue code 0260 was changed 8/1/2010 - The description for Revenue code 0280 was changed 8/1/2010 - The description for Revenue code 0289 was changed 8/1/2010 - The description for Revenue code 0636 was changed 08/13/2010 removed typographical error, no change in coverage 10/18/2010 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Colorado, New Mexico, Oklahoma and Texas were removed from this LCD because claims processing for those states are transitioning from FI Wisconsin Physicians Service (52280) to MAC Part A Trailblazer (04901). 02/21/2011 In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Delaware, District of Columbia, Maryland, New Jersey and Pennsylvania were removed from this LCD because claims processing for these states are transitioning from FI Wisconsin Physician Service (WPS 52280) to MAC Part A contractor Highmark (12901). 08/01/2011 annual review no change in coverage. Associated Documents Attachments Related Local Coverage Documents

Related National Coverage Documents Public Version(s) Updated on 09/18/2013 with effective dates 10/01/2013 - Updated on 08/26/2013 with effective dates 09/07/2013-09/30/2013 Updated on 01/22/2013 with effective dates 10/22/2012-09/06/2013 Updated on 10/09/2012 with effective dates 10/22/2012 - Updated on 08/03/2012 with effective dates 08/20/2012-10/21/2012