CMS Publishes Final Rule re. Separate Payments in Outpatient Settings

What You Need to Know

Medicare has issued a final rule expanding access to certain types of medical devices, non-opioid drugs, and biologics in the ambulatory surgery center and hospital outpatient department settings. The rule creates a defined pathway for these items to receive separate payment when used in conjunction with covered surgical procedures. This represents a departure from the historical policy of including the cost of medical devices etc. into the packaged payment made to the ASC/HOPD for the primary procedure. 

Under the new framework, a product may receive separate reimbursement if it meets defined statutory criteria, including published device- or product-specific clinical evidence showing its ability to reduce, replace, or avoid opioid use in the perioperative setting. When all criteria are met, Medicare will make a separate payment for the non-opioid product in ASCs and HOPDs by creating a HCPCS Level II C code for the device/product.

CMS has signaled that it will create a quarterly submission/review process similar to existing coding and new-technology pathways in the near future. That will permit parties to submit specific products for to CMS for consideration of separate payment. 

The law creating separate payments for these items in the ASC/HOPD setting - the No Pain Act - provides that it expires at the end of 2027 unless Congress votes to extend it beyond that date.

What This Means for You

Physicians and other healthcare providers cannot individually bill for items included for separate payment in the No Pain Act. However, ASCs and HOPDs can. Beginning next year, medical devices that meet the relevant criteria can be separately billed by those entities for reimbursement. The list of products eligible for separate reimbursement is likely to expand as CMS reviews and approves new submissions once it establishes a submission framework.

We will continue to provide you updates about products in the bracing and DME spaces eligible for separate payment in the ASC/HOPD settings as more information becomes available.