A new draft guidance for organ procurement organizations doing business in the U.S. would seem to tackle some pressing issues with organ donation, such as the conditions in which a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. 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.

The Centers for Medicare & Medicaid Services has cracked open its coverage policy for transcatheter aortic valve replacement devices a second time, and a wide range of stakeholders are providing feedback. Where the agency will land on questions such as the need for continued evidence development is difficult to predict, however, given that the agency is hearing anything but unanimity on the question.

The U.S. Centers for Medicare & Medicaid Services announced that several Medicare administrative contractors have formally withdrawn local coverage determinations for skin substitutes. There are questions, however, as to whether this will bring an end to excess spending on these products even though the agency has capped the rate paid for entire classes of products.

In a threshold event in the U.S., Medicare is planning to break through its obesity coverage barrier with a voluntary test of a model designed to enable Medicare Part D plans and state Medicaid programs to cover GLP-1 drugs prescribed for weight management.

Payers had their hands full in 2025 dealing with the raft of medical technologies that came through the globe’s regulatory review processes, although the nature of many of those challenges were conventional. On the other hand, payers struggled to keep pace with both the volume of conventional devices and the novelty of AI-driven devices in 2025, a problem that will carry over into the coming year.

Then there were three. With the administration’s Dec. 19 announcement of most-favored-nation (MFN) pricing deals with nine more biopharmas, only three of the 17 companies on the receiving end of U.S. President Donald Trump’s July 31 MFN ultimatum have yet to finalize terms with the White House – Abbvie Inc., Johnson & Johnson (J&J) and Regeneron Pharmaceuticals Inc.

Two U.S. Medicare administrative contractors (MACs) have removed CPT code 6468 from their group 1 CPT codes, a move that may cut rates for implant of Inspire Medical Inc.'s flagship product, the Inspire hypoglossal nerve stimulator for treatment of obstructive sleep apnea.

Much has been made of the recent skyrocketing of Medicare spending on skin substitutes, but a new enforcement action by the U.S. Department of Justice might help to explain some of those spending increases.