Products Include FDA-Approved Drugs Administered During Cataract Surgery with a Postoperative Indication in ASCs
Following ongoing advocacy from ASCRS and the Ophthalmic Pharmaceutical Coalition, which ASCRS leads, the Senate Appropriations Committee recently released its FY 2020 Labor-Health and Human Services (HHS) bill and legislative report, which includes support for Medicare coverage of innovative drug and products. Specifically, the report includes the following:
“The Committee is aware that innovative new drugs, and products approved by FDA for post-operative indications are not always clearly defined in CMS’ bundled payments. The Committee encourages CMS to explore different ways to reimburse for innovative drugs approved by FDA in a manner that protects beneficiary access and encourages continued innovation.”
The language included in the report is a direct result of our advocacy to seek separate payment in ASCs for FDA-approved drugs administered at the time of cataract surgery that have a postoperative indication. While report language does not have the force of law, it is key indicator to agencies about Congress’ intentions. The Appropriations Committee has yet to act on this bill and Congress has not finalized any of the other 11 2020 appropriations bills. The government is currently funded on a continuing resolution that expires November 21.
As a reminder, ASCRS and the Ophthalmic Pharmaceutical Coalition are advocating for separate payment for these drugs, because when they initially come on the market, they are paid for separately under pass-through status for up to 3 years. During that timeframe, CMS collects utilization data on the new drug and then at the end of the pass-through period, uses the data to incorporate the cost of the drug into the calculation of the facility fee. Once the drug is no longer paid on pass-through, however, ASCs struggle to afford to provide the drug as part of the facility fee and beneficiaries lose access to the drug. Since the drugs administered during cataract surgery have a postoperative indication and take the place of some or all of the postoperative drops that are separately covered and paid for under Part D, we contend that CMS should pay for them separately under Part B. As we have reported, our other advocacy efforts to date on this issue include several meetings with CMS, bipartisan letters from Congress, and we included the issue in our comments on this and previous years’ ASC proposed rules. We will keep you updated.