Description
Medical documentation will be reviewed to determine if the use of intravenous immune globulin for the treatment of Autoimmune Blistering Diseases (AMBDs) meets Medicare coverage criteria and is reasonable and necessary.
Affected Code(s)
J1459, J1556, J1557, J1561, J1566, J1568, J1569, J1572, J1544, J1576, J1599
Applicable Policy References
1. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1862(a)(1)(A)- Exclusions from Coverage and Medicare as a Secondary Payer
2. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1833(e)- Payment of Benefits
3. 42 CFR §405.929- Post-Payment Review
4. 42 CFR §405.930- Failure to Respond to Additional Documentation Request
5. 42 CFR §405.980- Reopening of Initial Determinations, Redeterminations, Reconsiderations, Decisions, and Reviews, (b)- Timeframes and Requirements for Reopening Initial Determinations and Redeterminations Initiated by a Contractor; and (c)- Timeframes and Requirements for Reopening Initial Determinations and Redeterminations Requested by a Party
6. 42 CFR §405.986- Good Cause for Reopening
7. Medicare Program Integrity Manual, Chapter 3- Verifying Potential Errors and Taking Corrective Actions, §§3.1- 3.6.6
8. Medicare National Coverage Determinations (NCD) Manual, Part 4- Coverage Determinations, Section 250.3- Intravenous Immune Globulin for the Treatment of Autoimmune Mucocutaneous Blistering Diseases
9. Medicare Claims Processing Manual, Chapter 17- Drugs and Biologicals, Section 80.6- Intravenous Immune Globulin
10. Medicare Program Integrity Manual, Chapter 13- Local Coverage Determinations, Section 13.5.4 Reasonable and Necessary Provisions in LCDs
11. CGS Administrators LCD L35891- Intravenous Immune Globulin; Effective 10/01/2015; Revised 03/23/2023
12. First Coast Service Options (FCSO) LCD L34007- Intravenous Immune Globulin; Effective 10/01/2015; Revised 02/05/2023
13. Palmetto GBA LCD L34580- Intravenous Immunoglobulin (IVIG); Effective 10/01/2015; Revised 05/18/2023
14. NGS LCA A52446- Intravenous Immune Globulin IVIG; Effective 10/01/2015; Revised 10/01/2022, Retired 10/31/2022
15. CGS LCA A56779- Billing and Coding: Intravenous Immune Globulin; Effective 08/01/2019; Revised 11/16/2023
16. FCSO LCA A57778- Billing and Coding: Intravenous Immune Globulin; Effective 10/03/2018: Revised 07/01/2023
17. Noridian LCA A57187- Billing and Coding: Immune Globulin Intravenous (IVIg); Effective 10/01/2019; Revised 07/01/2023
18. Noridian LCA A54641- Intravenous Immune Globulin: (IVIg) – NCD – 250.3; Effective 11/07/2015
19. Noridian LCA A54643- Intravenous Immune Globulin: (IVIg) – NCD – 250.3; Effective 11/07/2015; Revised 11/07/2015
20. Noridian LCA A57194- Billing and Coding: Immune Globulin Intravenous (IVIg); Effective 10/01/2019; Revised 07/01/2023
21. Novitas LCA A56786- Billing and Coding: Intravenous Immune Globulin (IVIG); Effective 08/08/2019; Revised 07/01/2023
22. Palmetto LCA A56718- Billing and Coding: Intravenous Immune Globulin (IVIG); Effective 07/25/2019; Revised 10/01/2023
23. WPS LCA A57554- Billing and Coding: Immune Globulins; Effective 11/01/2019: Revised 12/01/2022
24. HCPCS Level II Codebook
25. AHA ICD-10-CM Diagnosis Codebook