BPCI-A; Biologics Update; Orthopaedic Surgeons in Washington

From June 6-9, Orthopaedic leaders from around the country gathered to discuss the highest priority advocacy issues and meet with members of Congress during the 2018 National Orthopaedic Leadership Conference (NOLC). Orthopaedists discussed options for relieving the regulatory burden on physicians, addressing the opioid epidemic, and increasing access to care for disaster victims. 

Orthopaedic surgeons meet with members of Congress during the 2018 National Orthopaedic Leadership Conference (NOLC).

On May 20th, 2018, John McGraw, MD was sworn in as the only surgeon to serve on the Pain Management Best Practices Inter-Agency Task Force.  The Task Force consists of representatives from relevant HHS agencies, the Departments of Veterans Affairs and Defense and the Office of National Drug Control Policy. Non-federal representatives include individuals representing diverse disciplines and views, including experts in areas related to pain management, pain advocacy, addiction, recovery, substance use disorders, mental health, minority health and more. Members also include patients, representatives from veteran service organizations, the addiction treatment community and groups with expertise in overdose reversal, including first responders, medical boards and hospitals.

The AAOS Orthopaedic PAC was proud to welcome Julio Gonzalez, MD, JD to the 2018 NOLC in Washington, DC. Currently serving as a Florida State Representative, Dr. Gonzalez is a board certified orthopaedic surgeon running for United States House of Representatives for Florida’s 17th District. This seat is being vacated by Rep. Tom Rooney (R-FL), who is retiring after serving since 2009. If elected, Dr. Gonzalez would join Sen. John Barrasso as the only other orthopaedic surgeon in Congress and would be the sole orthopaedic surgeon in the House of Representatives.

In January of this year, the Centers for Medicare and Medicaid Services (CMS) launched the Bundled Payments for Care Improvement Advanced (BPCI Advanced) that will test 32 Clinical Episodes. BPCI Advanced will qualify as an Advanced Alternative Payment Model (APM) under the Quality Payment Program. This model will start on October 1, 2018, and the Model Period Performance will run through December 31, 2023. CMS will provide a second application opportunity in January 2020.

In May, the FDA and Department of Justice sought permanent injunctions against stem cell clinics in California and Florida to prevent them from marketing stem cell products without FDA approval.During its meeting at the 2018 NOLC, the AAOS Council on Advocacy called for a strong AAOS position on “bad actors” in this space, a sentiment echoed in Commissioner Gottlieb’s statement on the injunction : “We cannot allow unproven products that exploit the hope of patients and their loved ones.” AAOS recognizes the importance of cultivating an environment conducive to research and innovation andailure to police this space could have downstream consequences for research funding, coverage, reimbursement, and patient perception of these promising therapies. Common themes discussed by the Council on Advocacy include the desire for more evidence-based information about biologic products, resources for determining product regulatory status, and what to do when surgeons encounter the promotion and provision of unproven therapies.

Hospitals in the United States are reporting low supplies of the injectable opioids and anesthesia drugs that most surgery patients need during and after their procedures. The top five drugs in shortest supply are hydromorphone, fentanyl, morphine, epinephrine and the local anesthetic bupivacaine. The shortages involve pre-filled syringes of these drugs, as well as small ampules and vials of liquid medication that can be added to bags of intravenous fluids.

The shortages stem in part from manufacturing problems with a production facility in Kansas that the drug company Pfizer acquired when it purchased rival drug maker Hospira in 2015. Pfizer found numerous quality production issues and decided to shut the manufacturing facility down, explaining that full production at the plant will not resume until early 2019. The shortage was further complicated by government efforts to reduce addiction by restricting production of opioid drug products.

On April 11, 2018, leaders from the American Academy of Orthopaedic Surgeons, the American College of Foot and Ankle Surgeons, the American Orthopaedic Foot & Ankle Society, and the American Podiatric Medical Association came together in Chicago for a first-of-its-kind meeting of a Joint Task Force of Orthopaedic Surgeons and Podiatric Surgeons.

Click here, to view the interactive version of the map below, which features each state’s PAC support for 2017.

For the fourth year in a row, the National Orthopaedic Leadership Conference (NOLC) kicked off with the Orthopaedic Political Action Committee (PAC) congressional reception. To thank members of the Orthopaedic PAC’s top donor level, the Capitol Club, for their generous support, donors joined members of Congress and congressional staff on the roof of the W Hotel in Washington, DC. This is always a fabulous event and attendees enjoyed beverages, food, sweeping views of the White House and monuments, and of course, great company. Beyond AAOS’ advocacy leaders, including AAOS President, Dr. David Halsey, we had over 20 members of Congress in attendance: Rep. Ami Bera, MD, Rep. Neal Dunn, MD, Rep. Raul Ruiz, MD, Rep. Steve Stivers, Chairman of the NRCC, Rep. Greg Walden, Chairman of the Energy and Commerce Committee, to name a few.