Greetings, advocates! Here’s a brief, interim hodgepodge of updates to keep you posted on government advocacy before the deluge of information swamps you in San Diego.
The Next Big Thing: Part B Drug Reimbursements
Medicare currently plans to adjust reimbursement of doctors in the MIPS program in 2019, not only based on E/M office services, but also on items provided to patients—including Part B drugs. The math just doesn’t work on this: getting the average sales price (ASP) + 6% reimbursement on thousands of dollars for pass-through drug costs, then being at risk for a 4% reduction of that whole drug cost. Then in 2022, there’s a risk of a 9% cut, setting up an absurd situation in which doctors would effectively be paying 3% of patients’ infusion bills back to Medicare. Congressional staff members were aware of this problem when the ACR Executive Committee visited them on the Hill in September, but they are waiting to see what the CMS does. It appears that Medicare will publish its final ruling on this by Nov. 1.
To find out the thrilling next chapter in this story, saunter over to the advocacy sessions at the ACR/ARHP Annual Meeting on Sunday at 8:30 a.m. and Sunday at 1 p.m. (A member of Congress is scheduled to speak at this legislative and regulatory update session.) Meanwhile, your advocacy team has met with Congress, written letters through large coalitions and staged a large grassroots email campaign to get Congress to pressure Medicare to fix this. Stay tuned!
With five FDA-approved rheumatology biosimilars in the U.S., now is the time to learn about this topic, and stay informed as the landscape changes. In San Diego, check out the Great Debate and other biosimilars sessions with Jonathan Kay, MD, a rheumatologist in Worcester, Mass., affiliated with UMass Memorial Medical Center, and Gene Huffstutter, MD, a practicing rheumatologist in Hixson, Tenn.
Also stay tuned for the ACR’s upcoming biosimilars white paper. Meanwhile, the U.S. marketplace is still waiting for the FDA to finalize the approval pathway for interchangeable biosimilars (Note: These are the ones that could be substituted at the pharmacy for the bio-originator you prescribe). The ACR’s wish list for the FDA and CMS includes meaningful suffixes, individual billing codes for reimbursement and labeling changes (e.g., to clearly state if a drug is a biosimilar and whether it is interchangeable; the addition of clinical data or a hyperlink to the data package).