What's New? Using HCPCS Code C9399 (7/1/2022 Update)
Pharmacy Revenue Cycle Podcast
Release Date: 06/15/2022
The Heavy Hitters for July Quarterly Updates
Pharmacy Revenue Cycle Podcast
July 2023 is here and time to validate another round of quarterly updates from CMS. The JZ modifier, in addition to the JW modifier, is now required to effectively bill for drug waste (JW) and to attest when no drug was discarded (JZ) for all separately payable that are single-dose or single-use containers. Additionally, we have updated the Visante Quarterly Update Tool and the C9399 Tool to help organizations validate that their system is up to date with the recent changes.
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Beat Inflation with a Part B Rebate
Pharmacy Revenue Cycle Podcast
As a part of the Inflation Reduction Act of 2022, CMS is requiring manufacture rebates for certain Medicare Part B drugs in which the cost has exceeded inflation. Beneficiaries out of pocket costs will be reduced to 20% of the inflation-adjusted payment described in the Act.
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Don’t be “SAD”... An Alternative Way to Handle Self-Administered Drugs
Pharmacy Revenue Cycle Podcast
Self-administered drugs (SAD) have been a long-standing controversy when administered in a hospital outpatient setting from the perspectives of a patient, frontline healthcare workers, and billing. “Why does my Tylenol cost $10 per tablet, but the 1,000-count bottle I have at home was purchased for $3?” This question is often difficult to answer and may lead to unintended operational consequences.
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Botulinum toxin PA – Are you exempt?
Pharmacy Revenue Cycle Podcast
The new year brings a new focus on resolutions including prior authorization processes. In July 2020, Medicare implemented a prior authorization process for select services including botulinum toxin. Its time to revisit workflow processes and, if not exempt, confirm with respective teams that a prior authorization is obtained prior to providing the service.
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Designer HCPCS Codes are in the Mainstream Spotlight
Pharmacy Revenue Cycle Podcast
The Pharmacy Revenue Cycle is starting out with a new fashion design for 2023 as there are 36 new brand-specific HCPCS codes. CMS has been reviewing its approach for assigning for drugs that have been approved under the Food, Drug and Cosmetic Act 505(b)(2) New Drug Application (NDA) or the Biologics License Application (BLA) after October 2003. These drugs are not rated therapeutically equivalent to the reference drug listed in the FDA’s Orange Book and therefore are considered single-source products according to section 1847A(c)(6) of the Social Security Act. Each single source product...
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Hospital Outpatient Prospective Payment System (OPPS) Final Rule- CY2023
Pharmacy Revenue Cycle Podcast
The Centers for Medicare & Medicaid Services (CMS) provided the OPPS Final Rule for CY2023 in the Federal Register on Provisions in this rule will be effective for dates of service on or after January 1, 2023. Significant changes for drug reimbursement and coding occur in three areas: 340B-acquired drugs, non-opioid pain management reimbursement in Ambulatory Surgery Centers (ASC) and Hospital Outpatient Departments (HOPD), and new requirements for reporting waste in HOPD. 340B-acquired Drugs In light of the Supreme Court decision in American Hospital Association v. Becerra, 142 S. Ct....
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Drug Waste is Packed with a Punch and a Refund
Pharmacy Revenue Cycle Podcast
Dive into the CY23 CMS Physician Fee Schedule rule as it relates to the new requirements for discarded drugs or drug waste. A JW and JZ modifier are required for all Part B separately payable single-dose or single-use packages. Additionally, manufacturers are required to pay a refund for discarded drugs that exceed 10% of the total charges.
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Payment Increases for Biosimilars
Pharmacy Revenue Cycle Podcast
Payment Increases for Biosimilars On April 16th, 2022, the Inflation Reduction Act of 2022 was signed into law. Section 11403 requires a temporary increase in add-on payment for qualifying biosimilars from 6% to 8% for 5 years. This change was implemented on October 1, 2022, and CMS uploaded pricing files that already include the temporary price increase. Applicable 5-year period This increase began on October 1, 2022, for products for which payment was made by September 30, 2022. For other biosimilar products in which payment was made between October 1, 2022 - December 31, 2027, the 5-year...
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Car T-cell Therapy: Coverage and Billing-Outpatient (Updated – October 1, 2022)
Pharmacy Revenue Cycle Podcast
Chimeric Antigen Receptor (CAR) T-cell therapy is an example of a rapidly emerging immunotherapy approach called adoptive cell transfer (ACT) where patients’ own immune cells are collected and used to treat their cancer. This newsletter details coverage and billing instructions when the products are used on an outpatient basis and has been updated to reflect HCPCS codes current as of October 1, 2022. The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) regulates cellular therapy products, human gene therapy products, and certain devices related to...
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Vacating the 340B Payment Reduction Policy
Pharmacy Revenue Cycle Podcast
On September 28, 2022, the US District Court issued a that states the Department of Health and Human Services (HHS) is required to vacate the prospective portion of the 340B reimbursement rate outlined in the 2022 Outpatient Prospective Payment System (OPPS) Rule. In other words, payment rates must revert to the default of ASP + 6% rather than the reduced rate for select drugs of ASP - 22.5%. The decision was determined to not cause substantial disruption; thereby, requiring HHS to begin immediately. This was in response to American Hospital Association v. Becerra, 142 S. Ct. 1896 (2022), in...
info_outlineWhat’s NEW? Using HCPCS Code C9399 (July 1, 2022 update)
HCPCS code C9399-Unclassifed drugs or biologicals, can be used to bill for new drugs, biologicals, and therapeutic radiopharmaceuticals that are approved by the FDA on or after January 1, 2004 when a product-specific HCPCS code has not yet been assigned when furnished in hospital outpatient departments. (Medicare Claims Processing Manual, pg 63).
This C9399 tool includes the generic and brand names, approval dates, manufacturer, and a link to the prescribing information (PI). (<link to spreadsheet on Tools>) for injectable drugs that have been approved by the FDA but have not been assigned a HCPCS code by CMS. This list is updated each quarter to reflect newly released HCPCS codes. These “Not-otherwise-classified codes” (e.g. C9399) should only be used when a more specific HCPCS code has not been assigned.
What do I need to know about billing with C9399?
- HCPCS code C9399 is billed with a quantity of “1” (one) on the claim which is essentially a placeholder and directs the payer to review additional information in the NOTES section of the 837I claim.
- For Medicare and some other payers, discarded waste from separately payable single-dose vials must be recorded in the patient’s medical record. When reporting C9399, a separate charge line on the claim with the JW modifier should NOT be reported. Instead the amount administered and amount wasted (if documented) is reported in the NOTES section of the claim.
- For Medicare outpatients, when reporting C9399, hospitals must also report the National Drug Code (NDC) and quantity administered (expressed in the NDC unit of measure) as well as the date the drug was furnished in the NOTES section.
- For Medicare outpatients, the MAC will manually calculate the payment for the drug or biological at 95 percent of the average wholesale price (AWP). The MAC will pay 80 percent of the calculated payment to the hospital and the beneficiary will be responsible for the 20 percent co-pay after the deductible is met. Drugs/biologicals manually priced at 95 percent of AWP are not eligible for outlier payment. Other payers may pay similarly to Medicare or have an established fee schedules for new drugs.
- Some payers may provide alternate billing instructions (e.g. J3490, J3590) and they should be followed when available.
Please note that physician offices are not eligible to bill using HCPCS codes beginning with “C”, and must select a different unclassified code, e.g. “J” code.
Why have some drugs been approved for years, and still don’t have a HCPCS code assigned?
The HCPCS Workgroup assigns HCPCS code quarterly and holds an annual Public Meeting to gain feedback on their preliminary decisions. Typically a manufacturer or insurer submits an on-line application requesting a HCPCS code assignment. Approved codes are posted on the CMS HCPCS Quarterly update page.
What else should I know about these drugs that don’t have an assigned HCPCS code?
Medicare may consider some of these drugs that are administered subcutaneously as “self-administered” and therefore not covered in a hospital outpatient department. For other payers, the drugs may be covered in a hospital outpatient department, or covered as a pharmacy benefit rather than the medical benefit.
Medicare has also provided different instructions for billing diagnostic radiopharmaceuticals and contrast agents when a specific code has not been assigned. These instructions are available in the January 2017 OPPS update.
Shout-outs!
- Pharmacy should review these 50+ C9399 drugs to determine if they are in use and if so, ensure that the HCPCS code C9399 is used for billing with revenue code 636.
- Finance should review payments for C9399 to determine if payers are reimbursing at 95% AWP (Medicare and payers like Medicare), or at a contracted fee schedule rate.
- Revenue Integrity should review any drugs in use to ensure they are not on the facility’s “Self-Administered Drug” listing from the MAC, and therefore not covered when furnished in a hospital outpatient department.