AAOS October 30, 2018
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Bills Introduced to End Surprise Billing for Out-of-Network Care

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Regulatory Experts Provide Insight to Council on Advocacy

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Regulatory Experts Provide Insight to Council on Advocacy

On the second day of AAOS’ recent Council on Advocacy meeting, regulatory agency staff and experts provided insight into regulatory advocacy and reported on new initiatives at both the Food and Drug Administration (FDA) and the Center for Medicare and Medicaid Innovation (CMMI).

The first speaker was Philo D. Hall, JD, an Associate at Epstein, Becker and Green, where he advises clients on legal and regulatory compliance issues within Medicare, Medicaid, and other third-party reimbursement programs.  Hall provided a primer and insight on regulatory advocacy, while also discussing the strategic and stylistic differences between legislative and regulatory advocacy. He explained that regulatory advocacy may be a strategic choice when there isn’t a legislative vehicle or opportunity to resolve an issue. Additionally, regulatory agencies are required by statute to issue some annual regulatory updates and clarifying guidance can be issued at any time. Hall said it is important to identify the source of an issue or problem and it is often helpful to draft regulatory language and provide a specific ask to the agency staffers.

The second speaker was Vincent J. Devlin, MD, the Deputy Director of the FDA Division of Orthopaedic Devices at the Center for Devices and Radiological Health (CDRH). He was joined via audio by Mark Melkerson, Acting Director of the FDA Division of Orthopaedic Devices, and Captain Raquel Peat, Ph.D., MPH, the in-coming Director of the FDA Division of Orthopaedic Devices. The group announced a new initiative called the Total Product Lifecycle Reorganization (TPLC), which is designed to minimize organizational layers of review to achieve more efficient work processes and to facilitate information sharing. This reorganization package is currently under review and expected to be approved in late 2018. Meanwhile, the FDA will continue to communicate with its customers to facilitate interactions with the redesigned CDRH. The presentation then moved into a discussion of the National Evaluation System for Health Technology (NEST) and the Medical Device Innovation Consortium. NEST is a collaborative national evaluation system that will link and synthesize data from different sources across the medical device landscape, including clinical registries, electronic health records, and medical billing claims. AAOS has received a NEST grant and is working closely with FDA on this noteworthy project.

The last speaker was Chris Ritter, Ph.D., Director of the Patient Care Models Group (PCMG) at the CMMI. Ritter gave an overview of the current initiatives at CMMI, the Alternative Payment Models (APM), and some of their evaluation results. She also discussed how CMMI’s goals fit within the larger CMS goal of moving Medicare and Medicaid to value-based payments and improving the quality of patient care. The remainder of the presentation focused on the Bundled Payment for Care Improvement Advanced (BCPI Advanced), the newest Advanced APM. Ritter leads the team that designs and implements BPCI Advanced among several other models and said it’s likely to see wide participation by orthopaedic surgeons.

Several AAOS members lead practices that participated in BPCI Classic and are contracted to participate in the BPCI Advanced program, which launched October 1. The AAOS reiterated its ongoing concerns with the model, including the issue of a 50 percent cap on physician reimbursement, CJR precedence, and short turnaround time of without penalty drop out in March 2019. We will continue to advocate on BPCI Advanced on behalf of our members by following a robust Congressional and regulatory strategy.