01-309 Ophthalmology Injections Notification of Medical Review

Noridian Healthcare Solutions, LLC, as the Supplemental Medical Review Contractor (SMRC) for the CMS, is conducting post-payment review of claims for Medicare ophthalmology injections billed on dates of service from January 1, 2019 through December 31, 2019. 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.

Background

Vascular Endothelial Growth Factor (VEGF) plays an important role in physiologic and pathologic making of blood vessels and contributes to increased permeability across the blood-retinal and blood-brain barriers. VEGF is a central component of the pathologic process driving wet age-related macular degeneration (AMD) and other retinal disorders. Treatment with VEGF inhibitors can assist with reducing endothelial cell proliferation, vascular leakage, inflammation, and new blood vessel formation.

Reason for Review

The SMRC is tasked with performing a claim review on a sample of Ophthalmology Injection claims from January 1, 2019 through December 31, 2019. The SMRC will conduct medical record reviews in accordance with applicable statuory, regulatory, and sub-regulatory guidance.

Claim Sample Detail

CPT HCPCS
67028
  • C9257: Injection, bevacizumab, 0.25 mg
  • J0178: Injection, aflibercept, 1 mg
  • J2778: Injection, ranibizumab, 0.1 mg
  • J9035: Injection, bevacizumab, 10 mg

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 collection and submitting pertinent information to decrease provider burden.

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

  1. History and Physical
  2. Physician order for procedure/service
  3. Physician progress notes
  4. Results of pertinent diagnostic tests/procedures
  5. Photographs/sketches/drawings
  6. Procedure record/results/interpretation
  7. Exam results/findings
  8. Medication administration record
  9. Documentation to support level of utilization
  10. Any and all other documentation to support medical necessity of procedure/test for each eye
  11. Signature log or signature attestation for missing or illegible signatures within the medical record (all personnel providing services)
  12. Electronic record protocol/policy for electronic signatures
  13. Advance Beneficiary Notice of Liability (ABN); if applicable
  14. Any other supporting documentation
  15. 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
  16. PLEASE NOTE: It is the responsibility of the supplier/provider to obtain all documentation from the order/referring provider to ensure medical necessity criteria have been met.

References/Resources

  • Social Security Act (SSA) Title XVIII, Section 1812. Scope of Benefits.
  • Social Security Act (SSA) Title XVIII, Section 1814(a). Conditions of and Limitations on Payment for Services
  • Social Security Act (SSA) Title XVIII, Section 1815(a). Payment to Providers of Services
  • Social Security Act (SSA) Title XVIII, Section 1832. Scope of Benefits
  • Social Security Act (SSA) Title XVIII, Section 1833(e). Payment of Benefits
  • Social Security Act (SSA) Title XVIII, Section 1835(a)(2)(F). Procedure for Payment of Claims of Providers of Services
  • Social Security Act (SSA) Title XVIII, Section 1836. Eligible Individuals
  • Social Security Act (SSA) Title XVIII, Section 1861. Definitions of Services, Institutions, etc.
  • Social Security Act (SSA) Title XVIII, Section 1862(a)(1)(A). Exclusions from Coverage and Medicare As Secondary Payer
  • Social Security Act (SSA) Title XVIII, Section 1879(a)(1). Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed
  • Social Security Act (SSA) Title XVIII, Section 1893(b). Medicare Integrity Program
  • Code of Federal Regulations Title 42, Section 164.501. Definitions
  • Code of Federal Regulations Title 42, Section 405, Subpart I. Determinations, Redeterminations, Reconsiderations, and Appeals Under Original Medicare (Part A and Part B)
  • Code of Federal Regulations Title 42, Section 410.3. Scope of Benefits
  • Code of Federal Regulations Title 42, Section 411.15. EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT
  • Code of Federal Regulations Title 42, Section 424.5. Basic Conditions
  • Code of Federal Regulations Title 42, Section 482.24. Condition of participation: Medical record services
  • Medicare Benefit Policy Manual, Publication 100-02, Chapter 15, Sections 30.1. Covered Medical and Other Health Services
  • Medicare Benefit Policy Manual, Publication 100-02, Chapter 15, Sections 30.4. Optometrist’s Services
  • Medicare Benefit Policy Manual, Publication 100-02, Chapter 15, Sections 50-50.6. Drugs and Biologicals
  • Medicare Benefit Policy Manual, Publication 100-02, Chapter 16, Section 20. Services Not Reasonable and Necessary
  • Medicare Claims Processing Manual, Publication 100-04, Chapter 3. Modifiers
  • Medicare Claims Processing Manual, Publication 100-04, Chapter 4. Section 20.4. Reporting of HCPCS Service Units
  • Medicare Claims Processing Manual, Publication 100-04, Chapter 4. Section 20.6. Use of Modifiers
  • Medicare Claims Processing Manual, Publication 100-04, Chapter 7, Section 50. Part B Billing, Inpatient Part B and Outpatient
  • Medicare Claims Processing Manual, Publication 100-04, Chapter 12, Section 20.3. Bundled Services/Supplies
  • Medicare Claims Processing Manual, Publication 100-04, Chapter 12, Section 30. Correct Coding Policy
  • Medicare Claims Processing Manual, Publication 100-04, Chapter 23. Description of HCPCS
  • Medicare Claims Processing Manual, Publication 100-04, Chapter 30, Section 40.3.6. Advanced Beneficiary Notice of Non-Coverage
  • Medicare Claims Processing Manual, Publication 100-04, Chapter 30, Section 50.6.1. ABN Standards Proper Notice Documents
  • Medicare Program Integrity Manual, Publication 100-08, Chapter 3, Section 3.2.3.2. Time Frames for Submission
  • Medicare Program Integrity Manual, Publication 100-08, Chapter 3, Section 3.2.3.8 and 3.2.3.8 B/C. No Response or Insufficient Response to Additional Documentation Requests
  • Medicare Program Integrity Manual, Publication 100-08, Chapter 3, Section 3.3.2.4. Signature Requirements
  • Medicare Program Integrity Manual, Publication 100-08, Chapter 3, Section 3.4.1.3. Diagnosis Code Requirements
  • Medicare Program Integrity Manual, Publication 100-08, Chapter 3, Section 3.6.2.1 and 3.6.2.2. Coverage Determination and Reasonable and Necessary Criteria
  • Medicare Program Integrity Manual, Publication 100-08, Chapter 3, Section 3.6.2.4. and 3.6.2.5. Coding Determinations and Denial Types
  • Medicare Program Integrity Manual, Publication 100-08, Chapter 3, Section 3.6.2.5.A. Distinguishing Between Benefit Category, Statutory Exclusion and Reasonable and Necessary Denials
  • Medicare Program Integrity Manual, Publication 100-08, Chapter 4, Section 4.2.1. Examples of Medicare Fraud
  • Local Coverage Determination L33394 Drugs and Biologicals, Coverage of, for Label and Off-Label Uses. Effective. 10/01/2015-present
  • Local Coverage Determination L36962 Vascular Endothelial Growth Factor Inhibitors for the Treatment of Ophthalmological Diseases. Effective 07/24/2017-present
  • Local Coverage Article A52370 Billing and Coding: Bevacizumab and biosimilars. Effective 10/01/2015-present
  • Local Coverage Article A52451 Billing and Coding: Ranibizumab, Aflibercept and Brolucizumab-dbll. Effective 10/01/2015-present
  • Local Coverage Article A53008 Billing and Coding: Intraocular Bevacizumab. Effective 10/15/2015-present
  • Local Coverage Article A53009 Billing and Coding: Intraocular Bevacizumab. Effective 10/15/2015-present
  • Local Coverage Article A53121 Billing and Coding: Information Regarding Uses, Including Off-Label Uses, of Anti-Vascular Endothelial Growth Factor (anti-VEGF), for The Treatment of Ophthalmological Diseases. Effective 10/15/2015-present
  • Local Coverage Article A53386 Aflibercept (EYLEA®) Coding and Billing Guidelines. Effective 11/18/2011-present
  • Local Coverage Article A53387 Aflibercept (EYLEA®) Coding and Billing Guidelines. Effective 10/01/2015-present
  • Local Coverage Article A54674 Intravitreal Bevacizumab (Avastin®) Coding guidelines. Effective 10/15/2015-present
  • Local Coverage Article A55588 Vascular endothelial growth factor inhibitors for the treatment of ophthalmological diseases — new Part A and Part B LCD. Effective 07/24/2017-10/29/2021
  • Local Coverage Article A56716 Billing and Coding: Vascular Endothelial Growth Factor Inhibitors for the Treatment of Ophthalmological Diseases. Effective 10/03/2018-present
  • National Correct Coding Initiative Coding Policy Manual for Medicare Services (Coding Policy Manual) revised January 12, 2018.
  • Regeneron Pharmaceuticals, Inc. (2021). EYLEA® (aflibercept) Injection, for intravitreal use. Package Insert. Tarrytown, New York.
  • Genentech, Inc. (2014). Lucentis (ranibizumab injection). Package Insert. South San Francisco, California.
  • Genentech, Inc. (2009). AVASTIN® (bevacizumab). Package Insert. South San Francisco, California.

Last Updated Feb 16, 2022