Medicare Part B

Medicare Part B covers physician-administered drugs (infusions, injections given in a doctor's office or outpatient setting). Coverage is determined by National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and the drug's FDA-approved or CMS-recognized compendia indications. Part B does not have a traditional formulary — if a drug has an FDA-approved indication, it is generally covered.

Common Denial Patterns

• •LCD criteria not met — local Medicare Administrative Contractors (MACs) set LCD requirements
• •Off-label use not supported by CMS-recognized compendia
• •Medical necessity documentation insufficient
• •Incorrect billing codes (J-code, HCPCS) or modifier errors
• •Drug administered in non-covered setting

Step Therapy Approach

Medicare Part B generally does not impose step therapy in the same way commercial insurers do. However, MACs may have LCD criteria that effectively function as step therapy by requiring documentation of prior treatment trials. For oncology drugs (Protected Class), step therapy is restricted by law.

Appeal Process

Medicare Part B uses a 5-level appeal process: (1) Redetermination by MAC, (2) Reconsideration by QIC, (3) ALJ hearing, (4) Medicare Appeals Council, (5) Federal court. Initial redetermination must be filed within 120 days. Each level has specific timelines and requirements.

Tips for Appealing Medicare Part B Denials

1. 1.Check the LCD for your Medicare Administrative Contractor (MAC) region — LCDs vary by region
2. 2.Ensure correct J-code and HCPCS coding — billing errors are a common cause of Part B denials
3. 3.For off-label use, verify the indication is listed in a CMS-recognized compendium (NCCN, AHFS, etc.)
4. 4.Request an Advance Beneficiary Notice (ABN) if coverage is uncertain — this protects both patient and provider
5. 5.Medicare Part B has no annual or lifetime limits on covered drugs — use this as an appeal point if needed