| HHS Finalizes Interoperability and Information Blocking Rules
On March 9, the Department of Health and Human Services finalized two long-awaited rules: one by the Office of the National Coordinator (ONC) for Health Information Technology, and the other by the Centers for Medicare & Medicaid Services (CMS). Both rules strive to enhance interoperability and information sharing in the health care ecosystem. The ONC finalized rule sets criteria for “reasonable and necessary” activities that would not constitute information blocking, sets requirements for health IT developer adoption of application programming interfaces to allow patient access, use and exchange of electronic health record information at no cost, and requires usage of the U.S. Core Data for Interoperability (USCDI) when exchanging information, among other things. The CMS finalized rule sets requirements for hospitals to send electronic notifications when a patient is admitted, discharged, or transferred, as well as requirements for payor-to-payor exchange of a patient’s USCDI clinical data, and public reporting of providers who engage in information blocking and/or do not update their digital contact information. Learn more about the rules…
Final Push to Support Orthopaedic Research Program
With the deadline to make appropriation requests rapidly approaching, the AAOS is encouraging members to make one final push for critical orthopaedic research. Specifically it is asking surgeons to contact their legislators and urge them to support $35 million for the Peer Reviewed Orthopaedic Research Program (PRORP)–a competitive grant program under the Department of Defense that has provided $458.5 million to research institutions since 2009 for basic and clinical research. More than 15,000 patients have been enrolled in studies funded by the program to date, and more than half of all combat injuries sustained during Operation Iraqi Freedom and Operation Enduring Freedom involved extremity injuries and orthopaedic-specific conditions secondary to battle injury. Funded at $30 million since 2012, the additional $5 million is needed for the consortiums supporting the PRORP which are essential to ensuring that patients are placed in the right program and are not being unnecessarily used for multiple studies. Take Action via the Advocacy Action Center…
AAOS on Proposed Changes for Joint Replacement Model
On February 28, AAOS Council on Advocacy Chair Wilford K. Gibson, MD, FAAOS, released a statement in response to the newly proposed changes to the Comprehensive Care for Joint Replacement (CJR) Model. “The AAOS is encouraged by the new opportunities proposed which recognize the role and stewardship of practitioners in lower extremity joint replacement care,” he said, noting the incorporation of hip and knee replacements in the outpatient setting as well as a new risk adjustment methodology to account for patient health complexity. Dr. Gibson continued by reiterating AAOS’ opposition to the mandatory nature of the model and concern over the Center for Medicare & Medicaid Services’ (CMS) desire to readjust the target price using only the most recent year of claims data. “We are also concerned with the agency’s decision to continue with hospital leadership as opposed to physician leadership and exclude voluntary participants, many of whom have invested significant time, energy, and resources promoting value-based care,” he said Dr. Gibson concluded with the hope that CMS will create a future payment arrangement for procedures across the care continuum, and that AAOS looks forward to submitting formal comments by the April 24 deadline. Read the full statement…
Biological Products Now Deemed to be an FDA License
On March 4, the Food and Drug Administration (FDA) published final Question & Answer guidance on the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act (BPCI Act) of 2009. The Q&A, which is intended to be a guide for industry, incorporates the FDA’s updated definition of a “biological product.” Most notably, this guidance clarifies that a biological product already approved under the Federal Food, Drug, and Cosmetic Act on or after March 23, 2020, will be “deemed to be a license.” These products, which already have approved New Drug Applications , will not need to obtain Biologics License Applications. The guidance goes on to describe the compliance policy for the labeling of these deemed biological products. The AAOS Office of Government Relations will continue to monitor and assess FDA policy affecting biologic and biosimilar products. Access the FDA guidance… |
