Did you know that 340B discounted purchases had reached $66 billion during the period 2018 to 2023? Besides, the 340B program grew at a rate 3 times that of non-340B sales based on list prices during the same period.
But what exactly is the 340B program? It was designed by Congress in 1992 to help designated providers offer affordable care for vulnerable populations.
If you are a 340B participating entity, then you must know about the TB modifier. This guide will cover everything from clinical scenarios to guidelines. So, continue reading!
TB Modifier – Description
The TB modifier indicates that the reported drug or biological was acquired with a 340B drug pricing program discount.
The Centers for Medicare and Medicaid (CMS) introduced it under the Medicare Part B Inflation Rebate Guidance. All 340B participating entities must report modifier TB for separately payable Part B drugs or biologicals acquired under the 340B drug pricing program.
Besides, it is only an informational modifier. That is, it does not trigger a payment adjustment or a reduction in reimbursement rates. Instead, it is utilized solely for manufacturer rebate tracking and accounting. Also, it prevents duplicate dual-discount penalties on inflation rebate calculations.
Scenarios Where the TB Modifier is Applicable
Let’s review a few real-world clinical scenarios where the TB modifier applies:
Severe Asthma Management at a Ryan White Clinic
Picture a Medicare beneficiary with severe eosinophilic asthma. He receives a specialized, separately payable biologic injection, such as Mepolizumab, at a 340B-covered, non-hospital-based Ryan White HIV/AIDS clinic.
Since the drug was acquired through the 340B program and the claim is subject to Medicare’s 340B reporting rules, the billing team must append the TB modifier to the Part B drug claim line with the appropriate medication HCPCS code.
Hemophilia Factor Infusion via an Affiliated Contract Pharmacy
Consider a patient with severe hemophilia A who requires an infusion of a separately payable clotting factor product. However, the medication is dispensed and managed through a specialized contract pharmacy or supplier, i.e., affiliated with a 340B-covered Hemophilia Treatment Center.
Thus, the affiliated supplier or pharmacy can append the TB modifier to the specific drug claim line when billing Medicare Part B for the 340B-acquired factor product. It is essential to maintain proper compliance with the Inflation Reduction Act’s inflation rebate tracking.
Oncology Treatment at a DSH
Imagine a patient with stage IV colon cancer. He receives an intravenous infusion of a separately payable chemotherapy drug at an outpatient hospital clinic.
Note that the hospital is a registered 340B disproportionate share hospital (DSH). Besides, it purchased the biological drug at a 340B discount.
Here, the hospital billing team must submit the TB modifier to the claim line for the appropriate chemotherapy drug code.
TB Modifier – Billing Guidelines
Discussed below are some of the essential billing guidelines for the TB modifier:
Mandatory Universal Transition
Under the Medicare Part B Inflation Rebate Guidance, all 340B-covered entities must use TB on claim lines for separately payable Part B drugs. These include both hospital-based and non-hospital-based providers.
The JG modifier is no longer permitted for Part B claims, and any entity that previously used it must transition to the TB modifier, effective January 1, 2025.
Broad Supplier & Provider Applicability
Note that any supplier and healthcare provider who wants to bill Medicare Part B for a discounted 340B drug must use the TB modifier. These include:
- Grantees and non-hospital entities such as Ryan White HIV/AIDS clinics, hemophilia clinics, and Federally Qualified Health Centers (FQHCs).
- Outpatient Prospective Payment System (OPPS) hospitals.
- Previously exempt or optional, critical access hospitals (CAHs) must report modifier TB.
- Third-party providers or suppliers, including contract pharmacies billing on behalf of or affiliated with a 340B-covered entity.
Claim Line Application Rules
The TB modifier must be appended directly to the individual claim line for separately payable Medicare Part B drugs and biologicals. This primarily applies to those assigned a CMS status indicator of ‘K’.
Additionally, you should utilize automated billing configurations and claim scrubbing tools to flag missing modifiers. This will enable you to actively correct and resubmit claims to maintain regulatory compliance.
Conclusion
To summarize, the TB modifier acts as an informational tag only. Besides, it highlights to Medicare Part B that the reported drug or biological was acquired with a 340B drug pricing program discount.
Hopefully, this guide will help you use it properly. However, if you have trouble streamlining your billing workflow, feel free to opt for medical billing services from professionals like MediBillMD.
