Advocacy in Action

How the AAOS Office of Government Relations (OGR) is working for you … Voiced strong support for the newly introduced Hospital Competition Act of 2019. The bill combats the rising cost of health care by increasing choice among hospital providers, and it addresses several AAOS priorities, including lifting restrictions on physician-owned hospitals, discouraging hospital consolidation and certificate of need laws, expanding site neutral payments, and increasing price transparency.

FDA Issues Stem Cell Treatment Warning, Signals Increased Enforcement

Katherine Sale

On Dec. 20, 2018, the Food and Drug Administration (FDA) issued a warning letter to Genetech Inc., citing numerous deviations from current good manufacturing and tissue practices discovered during a June 2018 facility inspection.

Is Advocacy on Your Annual Meeting Agenda?

Kristen Coultas, Stacie Monroe

As you’re planning your schedule to make the most out of your time in Las Vegas at the Annual Meeting, we hope you have advocacy on the agenda. Not only is it an ongoing priority for the Academy, but it’s also the vehicle by which we can positively influence musculoskeletal care to benefit our members and patients.

PAC Corner: Orthopaedic PAC 2019 Donor Luncheon

The Orthopaedic Political Action Committee (PAC) cordially invites you to the PAC Donor Thank You Lunch, taking place Wednesday, March 13, from 11:30 a.m. to 1:30 p.m., at the Venetian/Sands Expo and Convention Center, Palazzo Ballroom O-P. The luncheon is open to all 2018 and 2019 PAC donors. The guest speaker will be former U.S. Senate member Dean Heller (R-Nev.). During his tenure in the Senate, Mr.

FDA Prepares to Modernize Its 510(k) Pathway to Keep Pace With Medical Device Advancements

Katherine Sale

Most medical devices used in the United States are cleared for marketing through the Food and Drug Administration’s (FDA) 510(k) pathway. Established by the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetics Act, the 510(k) pathway is based on the concept of substantial equivalence. A manufacturer must demonstrate that its product is as safe and effective as a predicate device that has already been cleared and is a legally marketed product.

Second Look—Advocacy

The Centers for Medicare & Medicaid Services’ (CMS) Center for Medicare & Medicaid Innovation stated that it would tackle Medicare Part D drug spending costs and increase its value-based design model nationwide. Per the new plan, Medicare Part D would take more of the financial burden from patients who max out their insurance limits. CMS estimates the changes would result in about $2 billion in savings for Medicare.

New Guidance Attempts to Resolve Confusion Regarding the Removal of TKA from IPO List

Shreyasi Deb, PhD, MBA

On Jan. 8, in a major win for AAOS’ advocacy efforts, the Centers for Medicare & Medicaid Services (CMS) issued unprecedented guidance to help resolve confusion regarding the removal of total knee arthroplasty (TKA) from the Medicare inpatient-only (IPO) list. The 2018 Medicare Outpatient Prospective Payment System (OPPS) Final Rule included a policy change allowing for payment of TKA procedures in either the hospital inpatient or outpatient setting.