Visante 
The National Uniform Billing Committee (NUBC) has announced two new condition codes to be reported on CMS-1450 (UB-04)/837I (Institutional) claims effective February 1, 2021 that impact drug products.
Condition Code 90– Expanded Access Approval (Service provided as part of an Expanded Access Approval)
Condition Code 91– Emergency Use Authorization (Service provided as part of an Emergency Use Authorization.
Condition codes are added to institutional claims to identify events relating to billing that may affect processing. The current UB-04 (837I) claim has 11 fields for condition codes. They are 2-character alphanumeric fields and are reported in numerical order. The condition codes are reported “per claim” and are not associated with a specific line on the claim.
Expanded Access
The FDA indicates that “expanded access” is also known as “compassionate use” and is a pathway for patients to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. When a patient receives a “compassionate use” medication, Condition Code 90 should be added to the claim.
Emergency Use Authorization
The FDA maintains a list of products that have received the designation of Emergency Use Authorization which include in vitro diagnostic products, personal protective equipment and related medical devices, ventilators and other medical devices and drug and biological products. A specific list of drug and biological products is found here.
As of 1/13/2021, the following drug products are listed as Emergency Use Authorizations and will require Condition Code 91 on the claim for dates of service on or after February 1, 2021:
1. Moderna COVID-19 Vaccine
2. Pfizer-BioNTech COVID-19 Vaccine
3. Casirivimab and Imdevimab
4. Baricitinib (Olumiant) in Combination with remdesivir (Veklury)
5. Bamlanivimab
6. COVID-19 convalescent plasma
7. REGIOCIT replacement solution that contains citrate for regional citrate anticoagulation (RCA) of the extracorporeal circuit
8. Fresenius Kabi Propoven 2%
9. Remdesivir for Certain Hospitalized COVID-19 Patients
10. Fresenius Medical, multiFiltrate PRO System and multiBic/multiPlus Solutions
Other current EUAs are related to: Anthrax, Ebola Virus, Enterovirus D68 (EV-D68), Freeze Dried Plasma, H7N9 Influenzae, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Nerve Agent, and Zika Virus.
Shout-Outs!
Two new condition codes effective February 1, 2021 are reported on claims when products are used under “Expanded Access” (Compassionate Use), or “Emergency Use Authorization”.
1. “Expanded Access” or “Compassionate Use” drugs may be administered for any investigational drug when approval is granted by the FDA. Pharmacy should establish a process to notify Clinical Trial Coordinators, Revenue Integrity and Billers to ensure that these drugs are properly identified in the medical record and billers are notified to add the condition code to the claim.
2. Clinical Trial Coordinators, Revenue Integrity and Billers should be made aware of these new codes and processes established to ensure the drug with “Emergency Use Authorization” designation is properly identified in the medical record and that the codes are added to claims when these drug products are administered.
3. FDA’s “Emergency Use Authorization” can be granted or retracted at any time. The FDA website should be reviewed frequently by Pharmacy and Pharmacy IT to determine the status of drug products. When changes occur, IT systems should be appropriately updated so that the medical record reflects the current drug status. Impacted personnel should also be notified of changes.
**Please note that the listing of drug-related EUAs is current as of 1/13/2021. We recommend that you check the FDA link above frequently to determine drug status on or after 2/1/2021.
The National Uniform Billing Committee (NUBC) was formed in 1975 to develop and maintain a single billing form and standard data set to be used nationwide by institutional, private and public providers and payers for handling health care claims and maintains the integrity of the UB-92 data set. The data set has become more than just a billing instrument as public health and health researchers use the data to gauge the delivery of health care services to patients.
