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ACR Hill Visits Yield Key Bill Support; Plus Medicare, Biosimilar Wins

Angus Worthing, MD, FACP, FACR  |  May 20, 2019

Greetings from Washington, D.C., where ACR leaders just held more than 100 meetings on Capitol Hill supporting reforms to step therapy and prior authorization, increased reimbursement for dual-energy X-ray absorptiometry (DXA), solutions to the rheumatology workforce shortage, and rheumatology-specific research at the Pentagon. We’re already hearing great news about our successes: Hours after our visit, Representatives Schakowski and Burgess introduced a bill to repay medical school loans for pediatric rheumatologists (and other specialists), to help solve a critical need for kids with arthritis. We also generated interest in the Senate to introduce a companion bill to the House’s Safe Step Act, which would allow our patients to be exempted from step therapy in cases where you predict the insurance-preferred drug will be ineffective, cause side effects or reduce adherence—or have another common sense reason.

Keep the momentum going by taking one minute right now to send a pre-written email to Congress. Visit the ACR website (for rheumatologists and rheumatology professionals) or simpletasks.org (patients and families). Your emails will help convince your elected leaders that our initiatives matter. And follow the fun at #Act4Arthritis.

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RheumPAC
For U.S. based ACR/ARP members, after you send those emails to Congress, do two more quick things: First, decide for yourself what it’s worth to your practice and your patients for the ACR to be fighting for us in Washington, D.C., and make an investment in RheumPAC. Last year, 4% of ACR/ARP members made that calculation about the value of advocacy and supported our bipartisan political action committee (PAC) on behalf of the other 96% of members. Imagine what we would be able to accomplish if that number increased to just 10%—per the ACR’s strategic plan goals.

Second, encourage your medical group, division or state society to support the new RheumPAC Advocacy Fund. What’s that, you say? It’s a fund that allows groups of rheumatologists to support advocacy. While only individuals can give to RheumPAC to support rheumatology champions in Congress, groups can now invest in the Advocacy Fund to defray administrative costs of fundraising, fly-ins and other expenses. Email [email protected] to find out more, or send a check to RheumPAC Advocacy Fund, 2200 Lake Blvd. NE, Atlanta, GA 30319.

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A Medicare Win
On May 16, the ACR logged another victory for our patients who receive in-office medications through Medicare. You may remember the ACR strenuously objected last August to the Trump administration’s announcement allowing Medicare Advantage plans to force our patients through step therapy before getting in-office infusion or injection medicines. This week, although the plan remains in effect, Medicare heeded the ACR’s request to protect patients currently receiving therapies (grandfathering/grandmothering) from going through step therapy. Instead of looking back only 108 days to check if patients are currently taking a medicine, plans must look back 365 days, where they will find many of our patients being treated at less frequent intervals.

A Biosimilar Win
Good news here, too. On May 10, the FDA finalized the approval pathway for interchangeable biosimilars in a way that balances biosimilar uptake and patient safety and provider confidence. The plan was endorsed by the ACR. As you may know, Congress created two FDA approval pathways for biosimilars: the biosimilar pathway, which has produced some currently available drugs, and the interchangeability pathway, to designate which biosimilars could be substituted by a pharmacist for a bio-originator or name brand biologic prescription. The FDA wisely decided that in order to be interchangeable, a drug will need to be proved to work in patients who switch back and forth three times between the bio-originator and biosimilar. This plan for three-switch studies should maximize the chance that pharmacists will only be able to substitute safe, effective drugs for our biologic prescriptions in the future.

In my personal view, biosimilars are the most medically acceptable and politically feasible way to lower drug prices and improve access to biologics for rheumatology patients in the U.S. Many of my patients are doing well on a biosimilar that is 20–30% less expensive than the originator drug. But if our patients don’t have access to safe, effective biosimilars—because of problems with regulations or the marketplace—the promises of lower costs and improved access will be foiled. The FDA has done its part to require rigorous clinical studies of interchangeable biosimilars to set the stage for substitution. Read more about biosimilars in the ACR’s open access white paper.

Ongoing Challenges
Pharmacy benefit managers (PBMs) still control our prescriptions using a scheme of kickbacks and opaque anti-competitive practices. But the ACR’s advocacy efforts at ATAP, together with CSRO, AWIR and other provider and patient groups have educated Congress about how PBMs incentivize price hikes through step therapy by preferring the drug with the most lucrative rebate package. And Congress is listening: House and Senate hearings have exposed how manufacturers and PBMs are both at fault for the high cost of drugs, and legislation to bring transparency and needed reforms is on the way.

Medicare reimbursement continues to threaten viability of rheumatology practices, with potential cuts through MACRA penalties, as well as recent Trump administration proposals to cut reimbursement for seeing patients (E/M codes)—the core of rheumatologists’ work—and to cut ultrasound diagnostic exams, which offer more information using less expensive and more patient-friendly technology. As your volunteer Government Affairs Committee chair, I became the starting gun on NPR and in The New York Timesfor the campaign against the E/M cuts last summer, and the campaign is working. In November, Medicare announced it would not go forward with the cuts as proposed, and last month a Medicare official told me that it favors an AMA plan to increase (not decrease) E/M reimbursements. Our arguments against cutting ultrasound reimbursement have also been warmly received in meetings at Medicare.

Stay tuned for this summer’s Medicare Physician Fee Schedule announcement; if these cuts aren’t reversed, I’ll tell you about your opportunity to raise your voice at regulations.gov.

Meanwhile, good news from the ACR’s RISE registry: Every single practice that submitted MIPS data to Medicare through RISE in MACRA’s first year (2017) not only avoided penalties for 2019 but also achieved exceptional bonus payments.

As I wrap up, I remind you to stay up to date and join the conversation to raise your voice by following me on Twitter. Even though I don’t have my own member of Congress yet (since I live in D.C.), I love giving you brief, actionable tweets about what you can do to exercise your First Amendment rights for rheumatology.

P.S.: Make a difference right now, and email Congress.


Angus Worthing, MD, FACP, FACR, chair, Government Affairs Committee, is a practicing rheumatologist in the Washington, D.C., metro area and clinical assistant professor of medicine at Georgetown University.

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Filed under:American College of RheumatologyLegislation & AdvocacyMeeting Reports Tagged with:ACR Capitol Hill visitAdvocates for ArthritisBiosimilarsmedical school loansMedicareMedicare Reimbursementpharmacy benefit managers (PBMs)Safe Step Act of 2019 (H.R. 2279)step therapy reform legislation

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