View the following information relating to drugs and biologicals:

• Appropriate use of not otherwise classified codes when billing drugs and biologicals
• Appropriate drug billing for Prolia® (Denosumab) injections, J0897
• Avoid claim denials: Bill drug wastage correctly using the JW modifier
• Reimbursement guidelines for radiopharmaceutical procedure codes
• Drugs and biologicals Part A – Using the JW and JZ modifiers
• Drugs and biologicals Part B – Using the JW and JZ modifiers
• 340B acquired drug - remedy lump sum payment: statement
• Reporting the national drug code
• Payment of codes for chemotherapy administration and nonchemotherapy injections and infusion

Medical documentation checklist

• Drugs and biologicals documentation

Related policy information

Some LCDs related to drugs and biologicals are listed below. Use the Interactive LCD index to locate additional coverage information.

Additional related articles: 

• A52578 Billing and coverage for drug wastage
• A52571 Self-administered drug exclusion list
• A59074 Billing and coding: complex drug administration coding

CMS IOM

• CMS IOM Publication number 100-02 Medicare Benefit Policy Manual, Chapter 15, section 80.6.1- Definitions
• CMS IOM Publication number 100-04 Medicare Claims Processing Manual, Chapter 4, section 20.4- Reporting of Service Units, 20.6- Use of Modifiers
• CMS IOM Publication number 100-04 Medicare Claims Processing Manual, Chapter 23- Fee Schedule Administration and Coding Requirements
• CMS IOM Publication number 100-08 Medicare Program Integrity Manual, Chapter 3, section 3.3.2.4- Signature Requirements, 3.6.2.2- Reasonable and Necessary Criteria, 3.6.2.4- Coding Determinations, 3.6.2.5- Denial Types, 3.6.2.5 A- Distinguishing Between Benefit Category, Statutory Exclusions and Reasonable and Necessary Denials, 3.2.3.8 C- No Response or Insufficient Response to Additional Documentation Requests
• CMS IOM Publication 100-04, Chapter 17, section 40 Drugs and Biologicals

Resources

• 42 Code of Federal Regulations (CFR)
  • Section 410 - supplementary medical insurance benefits
  • Section 414.40 - coding and ancillary policies
  • Section 424.5(a)(6) - sufficient information
  • Social Security Act, section 1833(e)
  • Social Security Act, section 1842(p)(4)
  • U.S Food & Drug Administration (FDA) labels
  • The National Comprehensive Cancer Network (NCCN) guidelines
  • Immunosuppressive drugs provider compliance tip

Social Security Act (Title XVIII) Standard References

• Title XVIII of the Social Security Act
  • Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury
  • Section 1862(a)(7). This section excludes routine physical examinations
  • Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim
• MLN fact sheet: Medicare Part B inflation rebate guidance: use of the 340B modifier