Articles and Blogs

Before the U.S. Food and Drug Administration (“FDA” or “Agency”) halted communications with the industry after the Presidential Inauguration on January 20, 2025, the Agency issued a final guidance for firms in the medical products industry titled,  “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions…Read More

Health care continues to drive private equity (“PE”) activity, creating opportunities for investors and traditional health care providers. Transactions in the health care space are especially complicated, layering health care regulatory and reimbursement considerations on top of a complex securities, antitrust, privacy and security framework. Hall Render’s PE team of attorneys and advisors leverage the…Read More

The Centers for Medicare & Medicaid Services (“CMS”) is reinforcing its emphasis on hospice quality of care and identifying fraud. On November 13, 2024, CMS issued a QSO Memo, “Ensuring Consistency in the Hospice Survey Process to Identify Quality of Care Concerns and Potential Fraud Referrals” (the “CMS Memo”), addressing the importance of consistency in the…Read More

On January 14, the Federal Trade Commission (“FTC”) published its Second Interim Staff Report (“Report”) on pharmacy benefit managers (“PBMs”), focusing on PBM pricing practices for specialty generic drugs. The Report described significant markups of cancer, HIV and other chronic condition specialty drugs and high reimbursement rates paid by Caremark Rx, Express Scripts and OptumRx…Read More

The United States Department of Justice (“DOJ”) recently settled part of a qui tam lawsuit under the False Claims Act for alleged violations of the Medicare “14-Day Rule” for $388,667. From March 2012 to November 2023, a laboratory and health system allegedly delayed submitting physician orders for certain laboratory testing until 14 days after patients’ hospital discharge…Read More

President Trump’s first week in office ushered in a number of changes to health care policies, including an executive order rescinding President Biden’s executive order on lowering prescription drug costs. The president also selected Dorothy Fink, MD, as interim HHS Secretary. Nonprofit hospitals’ credit downgrades outpaced credit upgrades in 2024, according to a recent article. The three…Read More

The Colorado Artificial Intelligence Act (“AI Act”), enacted in 2024, becomes effective February 1, 2026. It has been called the first comprehensive AI law in the country, likened to the European Union AI Law, and predicted to be first tested in employment disputes. In Part 1 of this article, we cover the basics of the AI Act…Read More

Health care continues to drive private equity (“PE”) activity, creating opportunities for investors and traditional health care providers. Transactions in the health care space are especially complicated, layering health care regulatory and reimbursement considerations on top of a complex securities, antitrust, privacy and security framework. Hall Render’s PE team of attorneys and advisors leverage the…Read More

The Hart-Scott-Rodino Antitrust Improvements Act of 1976 (“HSR Act”), as amended, requires all persons contemplating certain mergers or acquisitions that meet or exceed the jurisdictional thresholds (shown below) to file a premerger notification (an “HSR Filing”) with the Federal Trade Commission (“FTC”) Premerger Notification Office and Department of Justice (“DOJ”) Antitrust Division and to wait…Read More