01-080 Vitamin B12 with Modifier 25 Notification of Medical Review

Noridian Healthcare Solutions, LLC (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the Centers for Medicare & Medicaid Services (CMS), is conducting post-payment review of claims for Medicare Part B Vitamin B12 injections in addition to Evaluation and Management (E/M) visits with Modifier 25 billed on dates of service from January 1, 2020, through December 31, 2020. This notification includes the reasons for the review, documentation that will be requested in the Additional Documentation Request (ADR) letter, and resources providers/suppliers may wish to consult when submitting claims.


A potential vulnerability exists within Medicare if a provider bills for Vitamin B12 (HCPCS J3420), along with an injection service code (CPT 96372) for certain diagnoses. In addition, there is a potential vulnerability if the provider bills an E/M visit code (99212-99215) on the same date of service as a B12 injection when a not medically necessary, separately identifiable service is performed. Modifier 25 is used to report separately identifiable E/M services were provided in addition to a therapeutic drug administration service on the same day.

Reason for Review

CMS tasked Noridian, as the SMRC, to perform data analysis and conduct medical record review for Vitamin B12 (HCPCS J3420) with Modifier 25, along with an injection service code (CPT 96372) for certain diagnoses as well as E/M services on the same date of service. The SMRC will perform medical record review on supporting documentation, to determine if services were medically necessary. The SMRC will perform medical record review on Part B claims with dates of service (DOS) January 1, 2020, through December 31, 2020. The SMRC will conduct medical record reviews in accordance with applicable waivers/flexibilities/statutory, regulatory, and sub-regulatory guidance.

Claim Sample Detail

POS and Description CPT / HCPCS Code and Description
  • 11 – office
  • 20 – urgent care facility
  • J3420 – Vitamin B12
  • 96372 – Injection service code
  • 99212-99215 – E/M office visit for established patient

Access related project details below.

Documentation Requirements

Below is a list of specific documentation requirements that will be included in each ADR to obtain the necessary documentation to perform the review. Documentation requested has been made specific to assist the provider in collecting and submitting pertinent information to decrease provider burden.

Providers or suppliers are requested to submit each of the Documentation Requirements outlined below, if and as applicable to the claim on review.

  1. Physician/Non-Physician Practitioner (NPP) order or evidence of intent to order
  2. History and Physical reports (include medical history and current list of medications)
  3. Documentation supporting the diagnosis code(s) required for Vitamin B12 injection
  4. Progress notes and laboratory tests results indicating present or past values of serum B12 in addition to supporting the treatment for the identified diagnosis(es)
  5. Medical documentation for the injection, detailing prior course of treatment, frequency, duration, and effectiveness, including documentation that parenteral B12 is required because oral supplementation cannot be used or is insufficient
  6. The clinical indication/medical necessity for the injection including the number and location of injections as well as dosages and medications used
  7. Documentation to support the office visit/ E/M justification on the same DOS as injection code 96372 and HCPCS J3420
  8. Documentation to support the code(s) and modifier(s) billed
  9. Beneficiary’s medical records (which may include practitioner medical records, hospital records, nursing home records, home care nursing notes, physical/occupational therapy notes) that support the item(s) provided is/are reasonable and necessary
  10. Any addendum to record
  11. Documentation to support National Coverage Determination (NCD), Local Coverage Determination (LCD) and/or Policy Article requirements have been met, as applicable
  12. List of all non-standard abbreviations or acronyms used, including definitions
  13. Signature log or signature attestation for any missing or illegible signatures within the medical record (all personnel providing services)
  14. Advance Beneficiary Notice of Non-Coverage (ABN)/Notice of Medicare Non-Coverage (NOMNC)
  15. Any other supporting documentation
  16. If medical record documentation is submitted via esMD: Beneficiary identification, date of service, and provider of the service should be clearly identified on each page of the submitted documentation
  17. PLEASE NOTE: It is the responsibility of the provider to obtain all documentation from the ordering/referring provider to ensure medical necessity criteria have been met


Title XVII of the Social Security Act (SSA)

  • §1815(a) Payment to Providers of Services
  • §1833(e) Payment of Benefits
  • §1842(p)(4) Provisions Relating to The Administration of Part B
  • §§1861(e), (s)(2)(B)(K) Miscellaneous Provisions
  • §§1861(s)(2) (FF) and 1861 (hhh) Medical and other Health Services
  • §1862(a)(1)(A) Exclusions from Coverage and Medicare as Secondary Payer
  • §§1869(f)(1)(B), (f)(2)(B) Determinations; Appeals
  • §1879(a)(1) Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed
  • §1862(a)(7) Routine Physical Examinations
  • §1861(ddd) Preventative Services

Title 42 of the Code of Federal Regulations (CFR)

  • §410.3 Scope of benefits
  • §410.20 Physician Services
  • §410.74 Physician Assistants’ Services
  • §410.75 Nurse Practitioners’ Services
  • §410.134 Provider Qualifications
  • §410.15 Annual Wellness visits providing Personalized Prevention Plan Services: Conditions for and limitations on coverage
  • §410.16 Initial Preventive Physical Examination: Conditions for and limitations on coverage
  • §410.32 Diagnostic X-Ray Tests, Diagnostic Laboratory Tests, and Other Diagnostic Tests: Conditions
  • §411 Exclusions from Medicare and Limitations on Medicare Payment
  • §411.15(a)(1) and 411.15(k)(1) Particular services excluded from coverage
  • §424.5(a)(6) Basic Conditions

Internet Only Manual (IOM), Medicare National Coverage Determinations Manual (NCD), Pub. 100-03

  • Ch. 1, Part 2 §150.6 Vitamin B12 Injections to Strengthen Tendons, Ligaments, etc., of the Foot

IOM, Medicare Claims Processing Manual (MCPM), Pub. 100-04

  • Ch. 1, General Billing Requirements
  • Ch. 4, §20 Outpatient Hospital Services
  • Ch. 12, §30.6 Evaluation and Management Service Codes – General (Codes 99201 – 99499)
  • Ch. 12, §20.3 Bundled Services/Supplies
  • Ch 12, §30.6.7(D) Drug Administration Services and E/M Visits Billed on Same Day of Service
  • Ch. 14, §10 General
  • Ch. 17, Drugs and Biologicals
  • Ch. 17, §20.5.7 Injection Services
  • Ch. 23, Fee Schedule Administration and Coding Requirements
  • Ch. 23, §20.9 National Correct Coding Initiative (NCCI)
  • Ch. 30, §30 Determining Liability for Disallowed Claims Under § 1879
  • Ch. 30, §30 Healthcare Provider or Supplier Knowledge and Liability
  • Ch.13, §10.1 Billing Part B Radiology Services and other Diagnostic Procedures
  • Ch. 20, Payment Conditions for Radiology Services
  • Ch. 30, §30.2 Healthcare Provider or Supplier Knowledge and Liability
  • Ch. 30, §§30, 40, and 50 Advance Beneficiary Notice of Non-coverage (ABN)

IOM, Medicare Benefit Policy Manual (MBPM), Pub. 100-02

  • Ch. 6, §20 Outpatient Hospital Services
  • Ch. 16, §§10 and 20 Services Not Reasonable and Necessary
  • Ch. 1, §30 Drugs and Biologicals
  • Ch. 6, §20.5.3 Coverage of Outpatient Therapeutic Services Incident to a Physician’s Service Furnished on or After January 1, 2020 – Changes to Supervision Requirements
  • Ch. 7, § Administration of Medications
  • Ch. 15, §50.4.3 Examples of Not Reasonable and Necessary
  • Ch. 6, §20.4 Outpatient Diagnostic Services
  • Ch. 15, Covered Medical and Other Health Services Table of Contents (Rev. 259, 07-12-19)
  • Ch. 15, §80.61 Definitions
  • Ch. 15, §80 Requirements for Diagnostic X ray, Diagnostic laboratory, and other Diagnostic tests

Internet Only Manual (IOM), Medicare Program Integrity Manual (MPIM), Pub. 100-08

  • Ch. 3, § Time Frames for Submission
  • Ch. 3, § Additional Documentation Request Required and Optional Elements
  • Ch. 3, § No Response or Insufficient Response to Additional Documentation Requests
  • Ch. 3, §3.3.3 Reviewing Claims in the Absence of Policies and Guidelines
  • Ch. 3, § Documents on Which to Base a Determination
  • Ch. 3, § Signature Requirements
  • Ch. 3, §3.6 Determinations Made During Medical Review
  • Ch. 3, §13.5.4 Reasonable and Necessary Provisions in LCDs
  • Ch. 5, §5.11 Evidence of Medical Necessity
  • Ch. 3, § Coding Determinations
  • Ch. 3, § Denial Types
  • Ch. 3, § Coverage Determinations
  • Ch. 3, § Reasonable and Necessary Criteria
  • Ch. 3, § Limitation of Liability Determinations
  • Ch. 5, §5.9 Documentation in the Patient’s Medical Record
  • Ch. 6, §3.6.9 Medical Review of Diagnostic Tests
  • Ch. 6, §6.8 Medical Review of Evaluation and Management (E/M) Documentation
  • Ch. 13, §13.5.4 Reasonable and Necessary Provisions in LCDs

Local Coverage Determination (LCD)

  • LCD L33967 Vitamin B12 Injections

Local Coverage Article (LCA)

  • LCA A57755 Billing and Coding: Vitamin B12 Injections
  • LCA A57742 Billing and Coding: National Noncovered Services


  • CMS 1995 Documentation Guidelines for E/M services
  • CMS 1997 Documentation Guidelines for E/M services
  • American Academy of Professional Coders (AAPC). Evaluation and Management Coding, E/M Codes
  • Evaluation and Management Services Guide Booklet
  • MM11063: Summary of Policies in the Calendar Year (CY) 2019 Medicare Physician Fee Schedule (MPFS) Final Rule, Telehealth Originating Site Facility Fee Payment Amount and Telehealth Services List, CT Modifier Reduction List, and Preventive Services List effective January 1, 2019
  • NCCI Policy Manual for Medicare Services, Effective January 1, 2020. Chapter 1, Section D. Evaluation and Management (E/M) Services
  • NCCI Policy Manual for Medicare Services, Effective January 1, 2020. Chapter 1, Section E. Modifiers and Modifier Indicators
  • NCCI Policy Manual for Medicare Services, Effective January 1, 2020. Chapter 11. CPT Codes 90000-99999

Last Updated Aug 23, 2022