US · guidance
CMS Pub. 100-04, ch. 17, § 90.3
Hospital Outpatient Payment Under OPPS for New, Unclassified
Drugs and Biologicals After FDA Approval But Before Assignment of a
Product-Specific Drug or Biological HCPCS Code
(Rev. 3085, Issued: 10-03-14, Effective: ICD-10: Upon Implementation of ICD-10; ASC X12: January 1, 2012, Implementation: ICD-10: Upon Implementation of ICD- 10; ASC X12: November 4, 2014)
Section 621(a) of the MMA amends Section 1833(t) of the Social Security Act by adding
paragraph (15), Payment for New Drugs and Biologicals Until HCPCS Code Assigned.
Under this provision, payment for an outpatient drug or biological that is furnished as
part of covered outpatient department services for which a product-specific HCPCS code
has not been assigned shall be paid an amount equal to 95 percent of average wholesale
price (AWP). This provision applies only to payments under the hospital outpatient
prospective payment system (OPPS).
Beginning January 1, 2004, hospital outpatient departments may bill for new drugs and
biologicals that are approved by the FDA on or after January 1, 2004, for which a
product-specific HCPCS code has not been assigned. Beginning on or after the date of
FDA approval, hospitals may bill for the drug or biological using HCPCS code C9399,
Unclassified drug or biological.
Hospitals report in the ASC X12 837 institutional claim format in specific locations, or in
the “Remarks” section of Form CMS-1450):
• the National Drug Code (NDC),
• the quantity of the drug that was administered, expressed in the unit of measure
applicable to the drug or biological, and
• the date the drug was furnished to the beneficiary.
Contractors shall manually price the drug or biological at 95 percent of AWP. They shall
pay hospitals 80 percent of the calculated price and shall bill beneficiaries 20 percent of
the calculated price, after the deductible is met. Drugs and biologicals that are manually
priced at 95 percent of AWP are not eligible for outlier payment.
HCPCS code C9399 is only to be reported for new drugs and biologicals that are
approved by FDA on or after January 1, 2004, for which there is no HCPCS code that
describes the drug.
History
(Rev. 3085, Issued: 10-03-14, Effective: ICD-10: Upon Implementation of ICD-10; ASC X12: January 1, 2012, Implementation: ICD-10: Upon Implementation of ICD- 10; ASC X12: November 4, 2014)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
223975c6210aa3a0fcce2b93b5cbd6621e1118e0c93fc0594a9949fec6586a90
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