Pharmacy has a responsibility for data integrity. It’s an integral, vital part of ensuring that not only is the patient’s story told accurately and completely, but that all claims are processed, submitted and paid. The following four billing areas depict instances of which working outside the silo to join the revenue cycle/finance team is essential.
1. Drug Administration: Easy Income Often Overlooked (It’s a Bundle)!
Often the focus is on securing payment for drugs and biologicals administered in the outpatient or clinic setting. But, let’s not forget that the work to prepare the product for administration and the administration itself are part of an eligible bundle payment. Although the specifics of which codes to use for IV drug administration have been covered, explained and re-explained by CMS many times, confusion still appears to be tangling the lines of payment. Commercial payors/insurers often follow the CMS lead, so getting it right is crucial.
CMS recently published another guide that is paraphrased here (30.5 - Payment for Codes for Chemotherapy Administration and Nonchemotherapy Injections and Infusions [Rev. 13012; Issued: Dec. 19, 2024; Effective: Jan. 1, 2025; Implementation: Jan. 2, 2025]).
Codes for chemotherapy administration and nonchemotherapy injections and infusions include three categories of codes in the AMA CPTs: 1) hydration; 2) therapeutic, prophylactic, and diagnostic injections and infusions (excluding chemotherapy); and 3) chemotherapy administration. Keep in mind these key codes:
- 96360: IV infusion for hydration
- 96365: IV infusion for therapy, prophylaxis or diagnosis
- 96366: Additional hour of sequential infusion
- 96367: Additional sequential infusion, up to one hour
- 96368: Concurrent infusion
- 96374: Therapeutic, prophylactic or diagnostic injection; IV push
- 96409: Chemotherapy administration; IV, push technique
2. Therapeutic, Prophylactic, and Diagnostic Injections and Infusions (Excluding Chemotherapy)
Remember that these therapies can be considered as a bundle. The fluid used to administer the drug(s) is deemed to be incidental hydration and is not separately payable. Here’s a deeper look into some key categories in this group:
- use of local anesthesia;
- IV start;
- access to indwelling IV, subcutaneous catheter or port;
- flush at conclusion of infusion;
- standard tubing, syringes and supplies; and
- preparation of the drug.
3. Chemotherapy Administration (Hint: It’s Actually More Than ‘Chemotherapy’)
These codes apply to:
- parenteral administration of non-radionuclide antineoplastic drugs;
- antineoplastic agents provided for treatment of noncancer diagnoses (e.g., cyclophosphamide for autoimmune conditions) or to substances such as monoclonal antibody agents; and
- other biologic response modifiers.
These drugs are commonly considered to fall under the category of monoclonal antibodies: alemtuzumab, gemtuzumab (Mylotarg, Wyeth), infliximab, rituximab and trastuzumab. Hormonal antineoplastics include goserelin acetate and leuprolide acetate, among others. Medicare Administrative Contractors in your billing area may provide additional guidance. This highly complex administration requires qualified health professional work and monitoring well beyond the level of the therapeutic, prophylactic, and diagnostic injections and infusions. Direct supervision with advanced practice training in the special considerations of preparation, dosage and disposal is required, and the treatments often involve frequent monitoring of the patient and conferring with a physician. The administration of anti-anemia and antiemetic drugs by injection or infusion for cancer patients is not considered chemotherapy administration.
Included items, not separately billable:
- use of local anesthesia;
- IV access;
- access to indwelling IV, subcutaneous catheter or port;
- flush at conclusion of infusion;
- standard tubing, syringes and supplies; and
- preparation of chemotherapy agent(s).
4. Retroactive Discarded Drug Manufacturer Refund to CMS Now Underway
Pharmacy often thinks of this category as billing for waste, a topic covered in these columns multiple times, with constant reminders that this isn’t an automated process that fails to consider what actually happened to the unused portion (bit.ly/42RfyLU-PPN). If a separately payable drug from a single-dose container or single-use package is administered to a Medicare Part B beneficiary, Medicare pays for both administered and discarded amounts of the drug, up to the full labeled amount. Social Security Administration Section 1847A added provisions requiring manufacturers’ refund to CMS for certain of those discarded amounts. The refund amount is the amount of payment for discarded amounts of a refundable drug that exceeds an applicable percentage, which is required to be at least 10% of total charges for the drug in a given calendar quarter. For more details, see 42 CFR § 414.940(c), which is posted on the National Archives Code of Federal Regulations page.
Discarded Drug Refund Reports for CY 2023 have been loaded into the Manufacturer Payment Portal (requires login), with payments for refund amounts due now. Palmetto GBA was chosen by CMS to serve as a third-party administrator of manufacturer account creation in the Health Plan Management System. This reference publication from CMS has a wealth of information on these and other issues surrounding discarded drugs, including:
- What is a refundable drug?
- How are discarded amounts of refundable drugs identified?
- How is the discarded drug refund calculated?
- What if the manufacturer believes there is an error in the refund report?
For additional information on discarded drugs, see the 117th Congress Public Law 117–58, section 90004 of the IIJA (Pub. L. 117–58, issue Nov. 15, 2021).
Alert: Keep in mind that the provisions allow for audits by the manufacturer or CMS for anomalies or discrepancies. Practices that could cause these issues include automatically calculating and billing waste from eligible sized containers without knowing what actually happened to the amount. Also be careful with pooling containers, using overfill amounts and other practices that would contribute to a scenario where the waste requested is more than the amount of product purchased.
Healthcare Cost Transparency: A New Executive Order
Moving on from basic areas of billing that can trip you up, one recent development may affect your revenue cycle team. Building on a set of Hospital Price Transparency regulations from President Donald Trump’s first term, a new executive order (EO) directs the Treasury Department, Labor Department and HHS to improve upon and increase enforcement of the hospital and insurer price transparency requirements. Federal departments need to issue plans in 90 days to “require the disclosure of the actual prices of items.” The EO also calls for the following:
- ensure hospitals and insurers disclose actual prices, not estimates, and take action to make prices comparable across hospitals and insurers, including prescription drug prices;
- publicly disclose their prices, which includes requiring health plans to post their negotiated rates with providers as well as their out-of-network payments to providers and the actual prices they or their pharmacy benefit managers pay for prescription drugs; and
- update their enforcement policies to ensure hospitals and insurers are in compliance with requirements to make prices transparent.
For more information, see Pharmacy Practice News’ recent coverage of the EO here. For a CMS Medicare Learning Network fact sheet on the EO, click here.