Drugs and Biologicals
This page is a central location for drug and biological information, including CMS resources.
Spotlight
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Drugs and Biologicals Part A – Using the JW and JZ Modifiers
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Drugs and Biologicals Part B – Using the JW and JZ Modifiers
- ITVISMA® Cell Gene Therapy Drug: Get Billing Guidance
Policy Information
Not all services have a policy associated with them. We will consider Reasonable and Necessary Guidelines in the absence of an LCD, billing and coding article, NCD, or CMS manual instruction that limits coverage.
LCDs
Learn more about the LCD development process through the following:
Search for drugs and biologicals-related LCDs using these available resources:
NCDs
Search for drugs and biologicals-related NCDs using these available tools:
Medical Documentation
For a claim to be valid, documentation must demonstrate compliance with all applicable coverage, coding and billing requirements and substantiate the level of care billed. The following resources are specific to drugs and biologicals, but may not address all required medical documentation requirements:
Claim Submission and Reimbursement
- Appropriate Use of Not Otherwise Classified Codes When Billing Drugs and Biologicals
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Drugs and Biologicals Part A – Using the JW and JZ Modifiers
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Drugs and Biologicals Part B – Using the JW and JZ Modifiers
- Fee Development Process of New Drug Code Pricing
- Patients Purchasing Their Own Drugs and Biologicals (Brown Bagging)
- Reporting the National Drug Code
- Submitting High Dollar Claims for Single Use Vials
- Understanding Radiopharmaceutical Fee Schedule Amounts and Billing Expectations
- Understanding Local Contractor Pricing
- Use of JW and JZ Modifiers When Billing for Separately Payable Incident-to Supplies
- Quarterly Drug Pricing Files:
- MLN Connects Newsletter for September 24, 2026: Claims, Pricers & Codes - Medicare Part B Drug Pricing Files & Revisions: October Update
- MLN Connects Newsletter for June 25, 2026: Claims, Pricers & Codes - Medicare Part B Drug Pricing Files & Revisions: July Update
- MLN Connects Newsletter for March 26, 2026: Claims, Pricers & Codes - Medicare Part B Drug Pricing Files & Revisions: April Update
- MLN Connects Newsletter for January 8, 2026: Claims, Pricers &Codes - Medicare Part B Drug Pricing Files & Revisions: January Update
Additional Information
- View our FastTrack to Medicare Coverage Policies Tool to locate guidelines
- Drugs & Biologicals: Self-administered Drug Exclusions
- SPRAVATO® (Esketamine) Nasal Spray, CIII - Place of Service (POS) Requirements
CMS
- CMS IOM Pub. 100-02 Medicare Benefit Policy Manual, Chapter 6, Section 30
- CMS IOM Pub. 100-02 Medicare Benefit Policy Manual, Chapter 15, Section 50 and 60
- CMS IOM Pub. 100-04 Medicare Claims Processing Manual, Chapter 12, Section 20 and 30
- CMS IOM Pub. 100-04 Medicare Claims Processing Manual, Chapter 17, Section 40
- Discarded Drugs and Biologicals – JW Modifier and JZ Modifier Policy HCPCS Codes
- Medicare Program Discarded Drugs and Biologicals – JW Modifier and JZ Modifier Policy Frequently Asked Questions
- Medicare Part B Inflation Rebate Guidance: Use of the 340B Modifier
- Medicare Provider Compliance Tips: Immunosuppressive Drugs
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Billing 340B Modifiers Under the Hospital Outpatient Prospective Payment System (OPPS)
Education
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