Noridian Healthcare Solutions, LLC, as the Supplemental Medical Review Contractor (SMRC) for the CMS, has conducted post-payment review of claims for Medicare Medicare Part B of A Intravenous Immune Globulin (IVIG) billed on dates of service from July 1, 2018 through June 30, 2019. Below are the review results:

Background

The Office of Inspector General (OIG) published a report in July 2015, A-09-14-02024 , “Medicare Part B Overpayments for Selected Outpatient Drugs,” that identified significant overpayments exceeding $122 million made by Medicare contractors to providers for outpatient drugs during a three-year period from July 2009, through June 2012. As a result of these overpayments, the OIG conducted review and analysis of outpatient drug claims subsequent to the original audit period and found additional overpayments made from July 2012 through June 2014 for outpatient drugs. The OIG also found nearly 90% of overpayments were due to billing errors by the providers.

In response to the previous findings, the Centers for Medicare & Medicaid Services (CMS) implemented several Medically Unlikely Edits (MUEs) as prepayment edits to automatically detect claims billed with more units of service than what was determined reasonable for a provider to administer to a beneficiary on the same date of service for specific Healthcare Common Procedure Coding System (HCPCS) codes.

Additionally, as a result of the above OIG report, the previous Supplemental Medical Review Contractor (SMRC), conducted research, data analysis and medical review in 2016 of outpatient drug claims. IVIG was one of the top categories of outpatient drug claims recommended for further review.

Reason for Review

CMS tasked Noridian, as the SMRC, to perform data analysis and conduct medical review. Noridian completed medical record review on claims in accordance with applicable statutory, regulatory, and sub-regulatory guidance.

Common Reasons for Denial

• Incomplete/Insufficient Information
  • Social Security Act (SSA) 1833(e) and the Code of Federal Regulations (CFR) Title 42, Section 424.5(a)(6) require suppliers/providers to provide sufficient information to support that the basic conditions were met for Medicare payment. This is further outlined in Internet-Only Manuals, Pub 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.2.3.8.
• Incorrect Billing/Coding
  • The CFR Title 42, Section 414.40, the Medicare Program Integrity Manual, Chapter 3, Section 3.6.2.4-5 and 3.4.1.3, the Medicare Claims Processing Manual Chapter 5, Section 20, and the Medicare Claims Processing Manual Chapter 23 require the documentation submitted to support the number of units billed.

References/Resources

• SSA, Title XVIII, §§1833(e). Payment of Benefits
• SSA, Title XVIII, §§1833(t). Prospective Payment System for Hospital Outpatient Department Services
• SSA, Title XVIII, §§1861(s). Medical and Other Health Services
• SSA, Title XVIII, §§1861(t)(1). Drugs and Biologicals
• SSA, Title XVIII, §§1862 (a)(1)(A). Reasonable and Necessary
• SSA, Title XVIII, §§1862(a)(1)(D). Exclusions from Coverage. (Excludes payment for services that are investigational or experimental.)
• SSA, Title XVIII, §§1879(a)(1). Limitation on Liability of Beneficiary where Medicare Claims are Disallowed
• 21 Code of Federal Regulations (C.F.R) §640.100. Immune Globulin (Human) – Proper name and definition.
• 42 C.F.R §27. Therapeutic outpatient hospital or CAH services and supplies incident to a physician’s or nonphysician practitioner’s service: Conditions
• 42 C.F.R. §424.5(a)(6). Conditions for Medicare Payment – Basic Conditions, Sufficient Information
• CMS Internet Only Manual (IOM), Publication 100-02, Medicare Benefit Policy Manual, Chapter 6, Section 20. Outpatient Hospital Services
• CMS IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50. Drugs and Biologicals
• CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 23, Section 20.9. National Correct Coding Initiative [NCCI]
• CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 30, Section 50. Advance Beneficiary Notice of Noncoverage (ABN)
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.3.2.4. Signature Requirements
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.6.2.2. Reasonable and Necessary Criteria
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4. Reasonable and Necessary Provisions in an LCD
• Local Coverage Determination (LCD) L33394. Drugs and Biologicals, Coverage of, for Label and Off-Label Uses. Effective October 1, 2015
• LCD L34007. Intravenous Immune Globulin. Effective October 1, 2015
• LCD L34074. Immune Globulin Intravenous (IVIG). Effective October 1, 2015
• LCD L34314. Immune Globulin Intravenous (IVIG). Effective October 1, 2015
• LCD L34580. Intravenous Immunoglobulin (IVIG). Effective October 1, 2015
• LCD L34771. Immune Globulins. Effective October 1, 2015
• LCD L35093. Intravenous Immune Globulin (IVIG). Effective October 1, 2015
• LCD L35891. Intravenous Immune Globulin. Effective October 1, 2015
• Policy Article A52446. Billing and Coding: Intravenous Immune Globulin (IVIG). Effective October 1, 2015
• Policy Article A57778. Billing and Coding: Intravenous Immune Globulin. Effective October 3, 2018
• American Medical Association, Current Procedural Terminology (CPT) Manual, Professional Edition (2020)

Last Updated Nov 17, 2021