Please note: The below statements are for informational purposes only and are not coding or billing guidance. This information applies to traditional Fee-for-Service Medicare.
6/28/2024 Update:
In 2022, CSRO advocacy led CMS to issue a Technical Direction Letter (TDL) (dated August 12, 2022) to its Medicare Administrative Contractors (MACs) that effectively “paused” the “down coding” of complex drug administration services. In December 2023, after repeated appeals to CMS, the substance of the TDL was published in program transmittal #R12397OTN.
Despite this program transmittal, Palmetto GBA continued to inappropriately educate practices to “down code" their complex drug administrations. Last week, CSRO sent a letter directly to Palmetto demanding action and received confirmation that article A58527 will be retired in communication stating:
"The CMDs have reviewed your request and the Billing and Coding: Complex Drug Administration Coding Article A58527 will be retired effective December 21, 2023, due to the conflict with CR 13468. Providers should refer to the CMS Internet-Only-Manual (IOM) 100-04, Chapter 12, Section 30.5 for guidance on billing these services."
This update has been displayed on the Medicare Coverage Database (MCD), and CSRO has received confirmation that the retroactive retirement date is 12/21/2023. The explanation from Palmetto on where to find this substantiation on the MCD is included here:
[...if you scroll down to the revision history information table, under revision 10, you will see that it states: "This article is being retired due to conflict with Change Request (CR) 13468. Providers should refer to the CMS Internet-Only Manual (IOM), Pub. 100-04, Chapter 12, Section 30.5 for guidance on billing these services. This retirement is retroactive effective on 12/21/23."]
Please note that this communication is for informational purposes only and is not coding or billing guidance. As always, practices should code and bill items and services based on documentation in the medical record and in accordance with Medicare requirements and policy applicable to that particular item or service.
12/8/2023 Update:
Each day, we hear from concerned rheumatologists and administrators about issues impacting their practices and how CSRO is working to address those challenges.
This afternoon, CMS alerted CSRO to its newly published transmittal #R12397OTN that makes public the substance of its August 12, 2022, technical direction letter (TDL) language to the Medicare Administrative Contractors (MACs).
CSRO has repeatedly requested that CMS publish the substance of the TDL that directs the MACs to process and pay complex drug administration claims for rheumatologic drugs or to withdraw their “down coding” articles altogether while a long-term solution is identified. Clarification has been requested regarding the implementation date listed in the transmittal, and an update will be sent as soon as a response is received from CMS.
5/08/2023 Update:
It has been communicated to CSRO from CMS that the "pause" in down-coding of the drug administration codes (from complex to therapeutic) associated with certain rheumatologic medications remains in place following the August 12, 2022 Technical Direction Letter (TDL) to the MACs, and will remain in place until we are notified to the contrary by CMS.
If you have received a denial for the complex administration code based solely on the name of the drug, please email CSRO at info@csro.info with a redacted copy of the remittance advice (removing all PHI) showing the denial.
2/02/2023 Update:
CSRO remains in contact with CMS headquarters regarding challenges with billing and coding for drug administration services. According to CMS, the August 12, 2022 Technical Direction Letter (TDL) remains in effect, although guidance from local Medicare Administrative Contractors (MACs) may continue to direct practices to use “simple” administration codes for complex infusions and injections.
Please continue to contact CSRO at info@csro.info with claim denials from your local MAC that are inconsistent with the TDL.
9/20/2022 Update:
Last week, one Medicare Administrative Contractor (MAC) – WPS Insurance Corporation – formally retired their Local Coverage Article (LCA): “Billing and Coding: Complex Drug Administration Coding” effective August 12, 2022. The retired policy comes after months of CSRO and other stakeholder engagement with the Centers for Medicare and Medicaid Services (CMS) and MAC Contractor Medical Directors (CMDs) about the inappropriateness of these articles, and follows a CMS technical direction letter (TDL) to the MACs directing them to stop making adjustments or edits to claims for CPT codes 96401-96549 based solely on the specific drug or agent being administered.
Reports that other MACs intend to retire their LCAs have been shared with CSRO and other stakeholders; CSRO continues to monitor the Medicare Coverage Database (MCD) and will share any changes in these policies as they occur.
Related, WPS Insurance Corporation initiated a Targeted Probe and Educate (TPE) for Infusion Services in October 2021 that is “focused on those codes that fall under the subsection of hydration, therapeutic, prophylactic, diagnostic injection and infusion, and chemotherapy and other highly complex drug or highly complex biologic administration.” CSRO encourages rheumatology practices, especially in the WPS jurisdiction, to review the documentation and coding guidance that WPS states would represent “a successful review of infusion services.”
CSRO continues to work with CMS and MAC CMDs on a long-term solution to “down coding” of rheumatologic medications when administered in the physician’s office.
Please note that CSRO’s communications are for informational purposes only and are not coding or billing guidance. As always, practices should code and bill items and services based on documentation in the medical record and in accordance with Medicare requirements and policy applicable to that particular item or service.
8/26/2022 Update:
On August 12, 2022, CMS staff in the Office of the Administrator (OA) shared the following update with CSRO about ongoing efforts to address downcoding by the MACs for certain rheumatologist drugs:
“CMS has continued to work on this issue, and has met multiple times with the Medicare Administrative Contractors (MACs) recently. Today, a technical direction letter (TDL) was issued to all of the MACs that provides instruction regarding the payment for these codes while CMS further considers this matter. The TDL directs that the MACs shall not make claim adjustments or edits to claims for CPT codes 96401-96549 based solely on the specific drug or agent being administered. Claims for these codes that involve administration of monoclonal, complex biological, and rheumatological therapies shall be paid as complex administration, so long as all elements of these codes that are required for appropriate billing are met, using Medicare guidance/policy.”
Because the TDL is a contractual document, CMS explained that it is confidential and not able to be shared with the public. CSRO is monitoring certain submitted claims from rheumatology practices to see how these are processed by their MACs, and CSRO will report on that outcome in a future communication.
CSRO is working collaboratively with CMS officials on a long-term solution to this issue and will share updates as appropriate. Please continue to direct questions and report issues to info@csro.info.
Please note that this communication is for informational purposes only and is not coding or billing guidance. As always, practices should code and bill items and services based on documentation in the medical record and in accordance with Medicare requirements and policy applicable to that particular item or service.
Original Post:
Following CMS’ technical direction to MACs on June 10, 2022, which required MACs to temporarily pause medical review (i.e., sending additional documentation request (ADR) letters) when practices bill complex drug administration services associated with the provision of Cimzia® (J0717), Orencia® (J0129), Simponi Aria® (J1602), Stelara® (J3358), and Prolia® (J0897), CMS was concerned to hear from CSRO that the MACs continue to reject claims when the complex drug administration codes are submitted by rheumatology practices.
Since then, CMS has been working across various divisions with the agency to address the discrepancy with the MACs. As of this publication, they have not provided a timeline or any guidance on how practices should proceed in the interim. CSRO's public communication about the technical direction to the MACs was in accordance with the direction of CMS’ Center for Program Integrity (CPI). Like you, CSRO is frustrated by the lack of resolution between the entities.
