Separate payment under Part B for fda-approved Drugs with Post-Operative Indications administered in an asc

Our Position 

ASCRS and the Ophthalmic Pharmaceutical Coalition support separate payment under Medicare Part B for FDA-approved drugs with a post-operative indication administered at the time of surgery in Ambulatory Surgery Centers (ASCs).

How it Impacts You

Current packaging policies for surgical supplies in the outpatient setting pose a potential unintended consequence of limiting patient access to new and innovative treatments administered during the time of surgery but are FDA-approved for post-operative indications, such as post-operative pain and inflammation or other sequela of the surgery. Currently, these drugs are considered a surgical supply and packaged into the facility fee paid once they come off pass-through status. Pass-through status is a period of up to three years when manufacturers bring new, innovative drugs or devices to market and facilities are paid separately for using them. During this time, CMS collects utilization data on the new treatments and when the pass-through period expires, the data is used as factor in determining a new facility payment, and the cost of the drug is bundled into the facility fee.

CMS bundles drugs coming off pass-through into the facility fee because it considers them surgical supplies. However, new treatments administered during cataract surgery have FDA-approved indications for post-operative benefits and do not function as surgical supplies, so they should not be bundled into the facility fee. These drugs that replace some or all of the eye drops patients must administer post-procedure are covered and paid separately under Medicare Part D. ASCs, which typically operate on tight margins, will be unlikely to afford to offer these treatment options to patients if they are not paid for separately.