01-029 Intravenous Immune Globulin (IVIG) 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 Part B of A Intravenous Immune Globulin (IVIG) services billed on dates of service from July 1, 2018 through June 30, 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

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 will complete medical record review on claims in accordance with applicable statutory, regulatory, and sub-regulatory guidance.

Claim Sample Detail

TOB CPT / HCPCS
13X: Hospital Outpatient
  • 96365: Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour
  • 96366: Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour (list separately in addition to code for primary procedure)
  • J1459: Injection, immune globulin (privigen), intravenous, non-lyophilized (e.g., liquid), 500 mg
  • J1557: Injection, immune globulin, (gammaplex), intravenous, non-lyophilized (e.g., liquid), 500 mg
  • J1559: Injection, immune globulin (hizentra), 100 mg
  • J1561: Injection, immune globulin, (gamunex-c/gammaked), non-lyophilized (e.g., liquid), 500 mg
  • J1566: Injection, immune globulin, intravenous, lyophilized (e.g., powder), not otherwise specified, 500 mg
  • J1568: Injection, immune globulin, (octagam), intravenous, non-lyophilized (e.g., liquid), 500 mg
  • J1569: Injection, immune globulin, (gammagard liquid), non-lyophilized, (e.g., liquid), 500 mg
  • J1572: Injection, immune globulin, (flebogamma/flebogamma dif), intravenous, non-lyophilized (e.g., liquid), 500 mg
  • J2791: Injection, rho(d) immune globulin (human), (rhophylac), intramuscular or intravenous, 100 iu
  • J2792: Injection, rho (d) immune globulin, intravenous, human, solvent detergent, 100 iu

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.

  1. Physician or Non-Physician Practitioner (NPP) order for date of service
  2. History and Physical Documentation, if applicable
  3. Physician progress notes
  4. Diagnosis and clinical findings related to the service
  5. Procedure records/results/interpretation
  6. Infusion records/medication administration records (MARs), including documentation to support timed codes billed
  7. Nursing notes for the date(s) of service
  8. Documentation to support overutilization, if applicable
  9. Documentation to support continued use, if applicable
  10. Laboratory reports, if applicable
  11. Valid electronic and handwritten physician and/or clinician signatures
    1. Signature logs and signature attestation statement should be submitted when physician and/or clinician signatures are illegible
  12. Other documentation to support medical necessity

References/Resources

  • Social Security Act (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

Last Updated Jan 27, 2020