Noridian Healthcare Solutions, LLC (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the CMS, has conducted 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. Below are the review results:

Background

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 was 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 performed medical record review on supporting documentation, to determine if services were medically necessary. The SMRC performed medical record review on Part B claims with dates of service (DOS) January 1, 2020, through December 31, 2020.

The SMRC conducted medical record reviews in accordance with applicable waivers/flexibilities/statutory, regulatory, and sub-regulatory guidance.

Common Reasons for Denial

• No Response to the Documentation Request
  • Refer to Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.2.3.8 B/C, 42 CFR 424.5(a)(6), Social Security Act (SSA) Title XVIII, Section 1815(a), 1833(e), and 1862(a)(1)(A). The requested records were not received. This requires providers/suppliers to respond to requests for documentation within 45 calendar days of the additional documentation request.
• Incomplete and/or Insufficient Documentation
  • Refer to Internet-Only Manuals, Pub 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.2.3.8 B/C; 42 CFR 424.5(a)(6), Social Security Act 1833(e), and Social Security Act 1862(a)(1)(A). The documentation submitted was incomplete and/or insufficient. The submitted documentation was often missing records to support the Vitamin B12 injection had been administered. In addition, the progress notes to support the E/M service was not submitted.
• Services Not Performed as Billed
  • Refer to IOM, 100-08, Medicare Program Integrity Manual Chapter 3, Section 3.6.2.4 and Section 3.6.2.5, Medicare Claims Processing Manual Chapter 23. The documentation does not support the service was performed as billed. The documentation submitted did not support the level of E/M service billed.

References

Social Security Act (SSA), Title XVIII

• §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

42 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), Publication (Pub.) 100-03

• Chapter (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. 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, §40.1.2.4(A) Administration of Medications
• Ch. 15, §50.4.3 Examples of Not Reasonable and Necessary
• 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

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

• Ch. 3, §3.2.3.2 Time Frames for Submission
• Ch. 3, §3.2.3.4 Additional Documentation Request Required and Optional Elements
• Ch. 3, §3.2.3.8 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, §3.3.2.1 Documents on Which to Base a Determination
• Ch. 3, §3.3.2.4 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, §3.6.2.4 Coding Determinations
• Ch. 3, §3.6.2.5 Denial Types
• Ch. 3, §3.6.2.1 Coverage Determinations
• Ch. 3, §3.6.2.2 Reasonable and Necessary Criteria
• Ch. 3, § 3.6.2.3 Limitation of Liability Determinations
• Ch. 5, §5.9 Documentation in the Patient’s Medical Record
• Ch. 5, §5.11 Evidence of Medical Necessity
• 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)

• L33967 Vitamin B12 Injections

Local Coverage Article (LCA)

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

Other

• 1995 Documentation Guidelines for Evaluation and Management Services
• 1997 Documentation Guidelines for Evaluation and Management 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 Jul 18, 2023