Noridian Healthcare Solutions, LLC, as the Supplemental Medical Review Contractor (SMRC) for the CMS, has conducted post-payment review of claims for Medicare Ophthalmology Injections billed on dates of service from January 1, 2019, through December 31, 2019. Below are the review results:

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

Common Reasons for Denial

• Non-Response to the Documentation Request
  • The requested records were not received. Refer to IOM, Pub 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.2.3.8, Social Security Act (SSA) Title XVIII, Section 1815(a), 1833(e), and 1862(a)(1)(A).
  • No medical record documentation was received. Refer to Internet-only Manual Pub 100-08, Chapter 3, Section 3.2.3.8, 42 CFR 424.5(a)(6) and Social Security Act Title XVIII, Section 1815(a), 1833(e), and 1862(a)(1)(A).
• Insufficient Documentation
  • The documentation submitted was incomplete and/or insufficient. Refer to 42 CFR 424.5(a)(6), Social Security Act 1862(a)(1)(A), Social Security Act 1833(e).
  • Incomplete/Insufficient information. Refer to Internet-Only Manual, Pub 100- 08, Medicare Program Integrity Manual, Chapter 3, Section 3.2.3.8 C, Social Security Act 1833(e), 42 CFR 424.5(a)(6).
• Billing and Coding
  • The documentation submitted does not support the number of units 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 submitted does not support the modifier used. Refer to Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.6.2.4, 3.6.2.5, Pub 100-04 Medicare Claims Processing Manual Chapter 23 Pub 100-04, Medicare Claims Processing Manual, Chapter 4, Section 20.6.

References/Resources

Social Security Act (SSA) Title XVIII

• §1812. Scope of Benefits.
• §1814(a). Conditions of and Limitations on Payment for Services.
• §1815(a). Payment to Providers of Services.
• §1832. Scope of Benefits.
• §1833(e). Payment of Benefits.
• §1835(a)(2)(F). Procedure for Payment of Claims of Providers of Services.
• §1836. Eligible Individuals.
• §1861. Definitions of Services, Institutions, etc.
• §1862(a)(1)(A). Exclusions from Coverage and Medicare as Secondary Payer.
• §1879(a)(1). Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed.
• §1893(b). Medicare Integrity Program.

Code of Federal Regulations (CFR) Title 42

• § 405, Subpart I. Determinations, Redeterminations, Reconsiderations, and Appeals Under Original Medicare (Part A and Part B).
• § 410.3. Scope of Benefits.
• § 411.15. Exclusions from Medicare and Limitations on Medicare Payments.
• § 424.5. Basic Conditions.
• § 424.5(a)(6). Sufficient Information.
• § 482.24. Condition of participation: Medical record services.

Code of Federal Regulations (CFR) Title 45

• § 164.501. Definitions.

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

• Chapter (Ch) 15, § 30.1. Covered Medical and Other Health Services.
• Ch.15, §§ 30.4. Optometrist’s Services.
• Ch.15, §§ 50-50.6. Drugs and Biologicals.
• Ch.16, § 20. Services Not Reasonable and Necessary.

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

• Ch. 4, § 20.4. Reporting of Service Units.
• Ch. 4, § 20.6. Use of Modifiers.
• Ch. 12, § 20.3. Bundled Services/Supplies.
• Ch. 12, § 30. Correct Coding Policy.
• Ch. 23. Fee Schedule Administration and Coding Requirements.
• Ch. 30, § 50. Advance Beneficiary Notice of Non-Coverage (ABN).

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

• Ch. 3, § 3.2.3.2. Time Frames for Submission.
• Ch. 3, §§ 3.2.3.8 and 3.2.3.8 B/C. No Response or Insufficient Response to Additional Documentation Requests.
• Ch. 3, § 3.3.2.4. Signature Requirements.
• Ch. 3, § 3.4.1.3. Diagnosis Code Requirements.
• Ch. 3, §§ 3.6.2.1 and 3.6.2.2. Coverage Determination and Reasonable and Necessary Criteria.
• Ch. 3, §§ 3.6.2.4. and 3.6.2.5. Coding Determinations and Denial Types.
• Ch. 3, § 3.6.2.5.A. Distinguishing Between Benefit Category, Statutory Exclusion and Reasonable and Necessary Denials.
• Ch. 4, § 4.2.1. Examples of Medicare Fraud.

CMS coding policies

• National Correct Coding Initiative Coding Policy Manual for Medicare Services (Coding Policy Manual) revised January 12, 2018.

Related Local Coverage Determination (LCDs)

• 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

Related Local Policy Article (LCAs)

• 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

Other

• Regeneron Pharmaceuticals, Inc. (2021). EYLEA® (aflibercept) Injection, for intravitreal use. Package Insert. Tarrytown, New York. Approval 2011. Retrieved from eylea_fpi.pdf (regeneron.com)  
• Genentech, Inc. (2014). Lucentis (ranibizumab injection). Package Insert. South San Francisco, California. Approval 2006. Retrieved from LUCENTIS (ranibizumab injection) USPI (gene.com)  
• Genentech, Inc. (2009). AVASTIN® (bevacizumab). Package Insert. South San Francisco, California. Approval 2004. Retrieved from AVASTIN Prescribing Information (gene.com)  

Last Updated Oct 7, 2022