Republican AHCA Vote Pulled, Congress Turns to FDA and Appropriations Work | |||||
For questions or concerns on these or other advocacy issues, contact the Office of Government Relations at dc@aaos.org. | |||||
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Congress Talks Medical Device User Fee Act
On Tuesday, March 29, 2017, the Health Subcommittee of the House’s Energy and Commerce Committee held the third of its hearings on the reauthorizations of the User Fee Acts, due to expire on September 30 Tuesday’s hearing was devoted exclusively to the Medical Device User Fee Act (MDUFA), as committee members discussed the provisions of MDUFA IV and negotiated among industry stakeholders and officials at the Food and Drug Administration (FDA). On hand to answer the subcommittee’s questions was Dr. Jeffrey Shuren, the Director of the FDA’s Center for Devices and Radiological Health. In his opening statement, Dr. Shuren described many of the improvements MDUFA IV will make to the Act’s previous incarnation: “MDUFA IV agreement includes a new quality management program that will enhance consistency and predictability in premarket review processes. MDUFA IV agreement would also allow FDA to move forward in some critical and strategic areas such as strengthening our partnerships with patients. Strengthening patient input will allow us to promote more patient-centric clinical trials, advance benefit-risk assessments that are informed by patient perspectives, and foster earlier access to new devices. Another critical area supported by the MDUFA IV agreement is the development of the National Evaluation System for health Technology, or NEST.” Click here to read more. |
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Research Capitol Hill Days Urges NIH Funding The American Academy of Orthopaedic Surgeons’ Research Capitol Hill Days, an annual event promoting federal funding for musculoskeletal research, gives physicians, researchers, and patients the opportunity to meet with targeted Senators and Representatives to personally advocate for the future of musculoskeletal care, and specifically, increased research funding for the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) of the National Institutes of Health (NIH). Research Capitol Hill Days provides both doctor and patient participants with training, including an overview of advocacy skills and legislative outreach. Each year, over 60 orthopaedic patients, surgeons, and researchers met with U.S. Senators and Representatives to personally advocate for the future of musculoskeletal care and stress the importance of continued support of research funding. Meetings include members of the Senate and House Appropriations Committees. For more information, click here. | |||||
Antitrust Legislation Passes House On March 22, 2017, the House easily approved a bill that Republicans have said is part of their broader plan to remake the health care system. According to House Majority Leader Kevin McCarthy (R-CA), the Competitive Health Insurance Reform Act (H.R. 372) “makes needed reforms to the McCarran-Ferguson Act to reduce health care costs for consumers by ensuring competition.” McCarthy further stated that the legislation will protect consumers from consolidation in the health care marketplace and restore competition to the health care industry, “bringing down costs and expanding choices for American consumers.” Click here to read more. | |||||
Stark Briefing Addresses Value-Based Payment The Healthcare Leadership Council (HLC) hosted a panel briefing on Stark and anti-kickback law on March 24, in the Rayburn House Office Building. Panelists represented Ascension Health, a non-profit healthcare organization with 2,500 sites of care; Medtronic, a “global leader in medical technology”; and the healthcare practice of Crowell & Moring. The HLC arranged the event as part of its mission to modernize the fraud and abuse laws that can act as barriers to the kind of care coordination HLC envisions.
Panelists shared the sentiment that Stark and anti-kickback law were designed for a payment landscape that isn’t necessarily reflected in today’s transactions and can act as impediments to a value-based payment environment. They argued that the laws should be updated to provide clear, comprehensive protection for those value-based payment arrangements that do not pose undue risk of fraud/abuse by, for example, extending existing waivers to all payers; or, short of this, creating new exceptions and safe harbors; as well as clarifying key standards found in Stark exceptions and anti-kickback safe harbors. Click here to read more. |
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State Corner: Out of Network Update In March 2017, AAOS formally signed onto a coalition to fight the impact of potential regulation of provider payments in the case of “surprise billing” with several other specialty societies. The coalition principles are based on one overarching principle: When patients are treated, they should be confident in the knowledge that their health insurance will cover them. The coalition has opposed and supported bills on this issue in California, Washington, Oregon, Idaho, Nevada, Utah, Colorado, Texas, Florida, Indiana, Pennsylvania, New Jersey and others. Click here to read the coalition principles.
In late 2015, the American Association of Orthopaedic Surgeons (AAOS) informed orthopaedic surgeons of the National Association of Insurance Commissioners’ (NAIC) model legislation to regulate provider payments. At the time, AAOS recommended that Executive Directors monitor their state legislatures and actively oppose legislation that creates a ceiling on out-of-network payments to a percentage of Medicare. |
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What We’re Reading Is Obamacare Repeal Dead or a Legislative Zombie? Associated Press, 3/31/17 Intraparty Tensions Boil Over Amid GOP Health Care Struggles, Morning Consult, 3/30/17 After Repeal Failure, GOP Senators Propose Obamacare Subsidy Patch, The Hill, 3/30/17 Freedom Caucus Isn’t Backing Down After Trump Threat, Roll Call, 3/30/17 GOP Senators Propose Bill for People Without Insurance Options Next Year, Morning Consult, 3/29/17 Liberals See Opportunity in Health Care After GOP Meltdown, The Washington Post, 3/29/17 Could Trump’s Top DOJ Antitrust Pick Help Seal the Anthem-Cigna Deal? Modern Healthcare, 3/28/17 After GOP Health Bill’s Demise, More States Weigh Expanding Medicaid, The Wall Street Journal, 3/28/17 Repeal of Affordable Care Act Is Back on Agenda, Republicans Say, The New York Times, 3/28/17 Strung Out In Suburbia: Opioid Drug Crisis Hits the Suburbs, Modern Healthcare, 3/25/17 |