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PDAC Asks Catheter Manufacturers, Distributors to Provide Contact Info for Product Review, New HCPCS Codes
New HCPCS codes go into effect Jan. 1, 2026.

January 10, 2025 by Laurie Watanabe

The Centers for Medicare & Medicaid Services’ (CMS) Pricing, Data Analysis and Coding (PDAC) contractor is asking for contact information for manufacturers and distributors of intermittent urinary catheters that will be impacted by new HCPCS codes for catheters with hydrophilic coatings.

In a Dec. 31 bulletin, Palmetto GBA, the PDAC contractor, said it would start contacting catheter manufacturers and distributors this month “to establish lines of communication” as part of a secondary review of intermittent urinary catheters with current HCPCS codes A4351, A4352, or A4353.

“Manufacturers and distributors with affected product information on the PCL [Product Classification List] are encouraged to contact the PDAC via the Contact Us form to specify a primary point of contact (POC) no later than March 31, 2025,” the PDAC bulletin said. “Manufacturers and distributors for which no contact can be established will not have their product information updated on the PCL effective January 1, 2026, and may have their product information code end dated if determined obsolete.”

Palmetto said the effective date for the new HCPCS codes — which CMS published in its October 2024 final HCPCS coding decisions for the first biannual coding cycle for 2024 — is Jan. 1, 2026. The new codes are A4295 (Intermittent urinary catheter; straight tip, hydrophilic coating, each); A4296 (Intermittent urinary catheter; coude [curved] tip, hydrophilic coating, each); and A4297 (Intermittent urinary catheter; hydrophilic coating, with insertion supplies).

“PDAC will work with POCs for each manufacturer/distributor over the course of 2025 to assess whether their listed products qualify for one of the new hydrophilic intermittent urinary catheter HCPCS codes,” Palmetto said in the announcement. “All applicable product information identified for a code change will be captured and updated periodically on the Hydrophilic Intermittent Urinary Catheter Crosswalk. … Product listed on this document will be cross walked to the appropriate HCPCS code on the PCL effective January 1, 2026. Manufacturers and distributors should check the list periodically for updates and utilize the list as a reference to educate suppliers on pending billing code changes.

“Submission of a new CVR [code verification review] application is required if changes to existing PCL product information, such as manufacturer/distributor name, product name, or model number, are necessary or requested.”

Manufacturers and distributors who want their catheters to be product code verified for HCPCS codes A4351, A4352, or A4353 and added to the PCL list effective Jan. 1, 2026, “should submit their products to PDAC before Oct. 31, 2025,” Palmetto’s bulletin said. “These products will be coded to existing intermittent urinary catheter HCPCS codes and placed on the PCL for the interim before being cross walked with all other applicable product information to a new HCPCS code on January 1, 2026. All CVR applications received by PDAC after Oct. 31, 2025, will have codes assigned after January 1, 2026.

“PDAC is unable to back date code decisions to January 1, 2026.”

The American Association for Homecare (AAHomecare) published information from the PDAC bulletin in an email to members and stakeholders on Jan. 8. “AAHomecare thanks CMS and the PDAC for offering a valuable resource to support the IC industry in ensuring a seamless transition to the new coding system,” the association said.

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