In 2024, key federal healthcare regulations and policy developments—related to health insurance, privacy protections, reimbursement, biosimilar use and more—shaped the landscape of the practice of rheumatology in several important ways.
Unpacking the Court: An Analysis of Recent Supreme Court Decisions
Two recent Supreme Court decisions, Trump v. United States and Loper Bright Enterprises v. Raimond, have broad implications for administrative authority and regulatory advocacy. Joseph Cantrell, JD, analyzes how these decisions may affect the relative power of the different branches of government.
Federal Regulatory Actions Against Healthcare Consolidation
In recent months, the U.S. Department of Justice and Federal Trade Commission have started to take action to rein in antitrust behavior, including banning noncompete agreements in the for-profit sector and establishing a taskforce on healthcare monopolies.
After the 2020 Election, What’s in Store for Rheumatology Advocacy?
Despite high voter turnout and many new faces entering Congress, minimal power shifts in most levels of government will have implications for the ACR’s advocacy agenda in 2021.
Prepare Now to Sell Your Medical Practice
Selling a medical practice can be a lucrative endeavor. One of the most important phases of any sale transaction is the due diligence process. During this phase, a potential buyer and their advisors have the opportunity to examine the seller’s books, records and files in great detail to ensure that the buyer is comfortable purchasing…
EMA Flags Faulty Generic Drug Data, Backs Sales Halt
(Reuters)—The European Medicines Agency (EMA) recommended suspending sales of some generic drugs after a review found that data collected by a contract research company in India for their approval was unreliable. The EMA’s list included drugs made by some of the top generic drugmakers, including Teva Pharmaceutical Industries Ltd., Mylan NV and Novartis AG’s Sandoz….
Comment Period Open for FDA Draft Guidance on Osteoporosis Treatments; Plus FDA Rejects Abuse-Deterrent Apadaz
The FDA is currently accepting comments on a draft guideline for osteoporosis treatments, which calls for more research into the long-term effects of drugs on bone quality. Also, the FDA has rejected an application for approval of Apadaz in its current form…
Phase 2 of HIPAA Audit Program Launches
With many competing priorities facing physician practices, HIPAA compliance and security is not a topic that usually makes it to the top of the list. But this is not the case with the Department of Health and Human Services’ Office for Civil Rights (OCR), because it has initiated a new phase of audits of physician…
U.S. Senate Moves Closer to Confirming Califf to Lead FDA
WASHINGTON (Reuters)—The U.S. Senate on Monday moved closer to confirming Dr. Robert Califf to lead the U.S. Food and Drug Administration, overriding opposition from several senators who had sought to block a vote on the issue. In a procedural move designed to prevent the opponents from blocking the confirmation indefinitely, the Senate voted 80 to…
U.S. & EU Regulators Urge Indian Drug Companies to Step Up Standards
MUMBAI (Reuters)—U.S. and EU drug regulators called upon India’s pharmaceutical sector on Tuesday to step up efforts to improve manufacturing standards and ensure the reliability of data if it is to maintain its dominance in the generic drugs industry. India’s $15 billion pharmaceutical industry, an increasingly important global supplier of cheaper generic medicines, has been…