Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle.

Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle.

The U.S. FDA and CMS are teaming up to give Medicare beneficiaries quicker access to breakthrough medical devices and provide manufacturers with certainty of reimbursement.

When the U.S. CMS didn’t get takers for its voluntary Better Approaches to Lifestyle and Nutrition for Comprehensive Health (BALANCE) model to cover obesity drugs under Medicare Part D, the agency punted. It announced late April 21 that it will indefinitely delay the BALANCE model in Medicare but extend its temporary Medicare GLP-1 Bridge demonstration model through the end of 2027. (The Medicaid BALANCE model will still kick in this year in states that choose to participate in it.)

Even though case law has established that 340B-covered providers can’t sue drug companies for overcharging on the steeply discounted drugs, the Adventist Health System of West tried a new door into court – as a whistleblower under the False Claims Act.

A new draft guidance for organ procurement organizations doing business in the U.S. would seem to tackle some pressing issues with organ donation, such as the conditions in which a problem qualifies as an adverse event. Perhaps of greater interest to companies in the organ container business is that the Centers for Medicare & Medicaid Services is intent on increasing the availability of organ donations to deal with an insatiable demand for donated organs.

The pressure on U.S. drug prices continues, with the CMS lining up the drugs for round 3 of negotiations, which will set maximum fair prices to go into effect in 2028. The slate includes 15 drugs and, for the first time, opens the negotiations to Part B drugs, as well as Part D. Consequently, seven of the 15 selected drugs are biologics.

The U.S. Department of Justice reported that it has indicted two executives with Zynex Inc. for Medicare fraud, but in one of the stranger twists in recent fraud cases, one of the executives allegedly attempted to interfere with the personal lives of members of the media who were reporting on the company’s legal problems.

The U.S. Department of Justice said recoveries under the False Claims Act in fiscal year 2025 reached a record of more than $6.8 billion, more than 80% of which came from health care cases.

The U.S. Centers for Medicare & Medicaid Services announced Jan. 15 that the estimated volume of improper payments for Medicare fee-for-service care in fiscal 2025 was nearly $29 billion while the number for Medicare managed care was in excess of $23 billion.