CMS

Supreme Court upholds FCA’s ‘whistle while you work’

Tue, 19 May 2026 12:00:00 -0400

Eli Lilly and Co. lost its bid to have the U.S. Supreme Court strike down the whistleblower provisions in the False Claims Act (FCA) as unconstitutional.

US Supreme Court swats down several biopharma IRA challenges

Mon, 18 May 2026 12:00:00 -0400

It looks like the end of the road for many of the court challenges to the Inflation Reduction Act’s (IRA) provision requiring Medicare to negotiate prescription drug prices. The U.S. Supreme Court denied cert May 18 to petitions brought by six biopharma companies that raised questions about the constitutionality of the negotiations. All but one of the suits involved were denied in the Third Circuit; the other one was denied in the Second Circuit, so there is no circuit split – yet.

Bio Korea 2026: US policy risks shift to execution framework

Tue, 05 May 2026 12:00:00 -0400

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.

Bio Korea 2026: US policy risks shift to execution framework

Mon, 04 May 2026 12:00:00 -0400

US legislative reforms needed to make biosimilars competitive

Mon, 27 Apr 2026 12:00:00 -0400

Now that the FDA is on board with doing away with the U.S.’ unique two-tier biosimilar pathway, the biosimilar industry is urging Congress to pass the bipartisan Biosimilar Red Tape Elimination Act, which would recognize that biosimilars and interchangeables are one and the same.

FDA, CMS partner to deliver RAPIDly for innovative devices

Thu, 23 Apr 2026 12:00:00 -0400

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.

CMS to Bridge coverage for obesity drugs as BALANCE teeters

Wed, 22 Apr 2026 12:00:00 -0400

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.)

HHS budget hearing not so much about budget

Thu, 16 Apr 2026 12:00:00 -0400

U.S. Health and Human Services (HHS) Secretary Robert Kennedy made his first stop April 16 on a congressional tour in support of President Donald Trump’s proposed fiscal 2027 budget, which would reduce discretional spending for HHS and its agencies by about 12%.

CMS looks to bring Rx prior authorization into digital age

Mon, 13 Apr 2026 12:00:00 -0400

In a move that could give patients quick access to drugs their doctors prescribe, the U.S. CMS is proposing a rule giving insurers no more than 24 hours to respond to urgent prior authorization requests and 72 hours for standard requests. The rule also would require full disclosure of claims denials and appeals outcomes.

340B provider finds new way into court over Rx price disputes

Wed, 18 Mar 2026 12:00:00 -0400

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.

Samsung is adding trials and EHR access to Galaxy devices

Tue, 17 Mar 2026 11:00:00 -0400

Samsung Electronics Co. Ltd. is partnering with Verily Life Sciences LLC, an Alphabet Inc. company, and B.well Connected Health to turn Samsung Galaxy phones and smart watches into the “front door” of U.S. health care.

Samsung is adding trials and EHR access to Galaxy devices

Wed, 11 Mar 2026 12:00:00 -0400

Med-tech fraud charges lead to prison time

Mon, 09 Mar 2026 12:00:00 -0400

Patrick Cassells, of Fulshear, Texas, was sentenced March 6 to more than seven years in prison and ordered to pay more than $25 million in restitution and forfeiture after he pleaded guilty nearly two years ago to one count of health care fraud that involved the three durable medical equipment companies he owned and operated.

Changing US FDA trial default a global matter

Fri, 27 Feb 2026 12:00:00 -0500

The U.S. FDA’s expectations that its new default position of basing marketing authorization of novel drugs on one adequate, well-controlled trial may be overstated. In explaining the policy in a recent article in The New England Journal of Medicine, FDA Commissioner Marty Makary and CBER Director Vinay Prasad said they expect the initiative will create a “surge in drug development,” substantially reduce development costs and will speed drugs to market. While the initiative could reduce the time to the U.S. market, those expectations don’t take into consideration global norms and payer expectations.

HRSA taking another look at impact of 340B rebates

Tue, 17 Feb 2026 12:00:00 -0500

A 340B rebate pilot program may have been enjoined last year, but that doesn’t necessarily mean it’s dead.

Abbvie claims CMS’ selection of Botox violates the IRA

Thu, 12 Feb 2026 12:00:00 -0500

Undeterred by all the unsuccessful biopharma suits challenging the U.S. Medicare price negotiations, Abbvie Inc. filed its own complaint Feb. 11 in the U.S. District Court for the District of Columbia, seeking to undo CMS’ selection of Botox in the third round of the negotiations.

CMS rewrites organ procurement rule to expand availability

Fri, 30 Jan 2026 11:00:00 -0500

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.

US CMS names its choices for third round of price negotiations

Wed, 28 Jan 2026 12:00:00 -0500

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.

Medicare improper payment rate down in FY 2025

Tue, 20 Jan 2026 11:00:00 -0500

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.

CMS hears discord in comments for TAVR coverage memo

Fri, 16 Jan 2026 11:00:00 -0500

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.

Skin substitute LCDs withdrawn, spending concerns remain

Mon, 29 Dec 2025 11:00:00 -0500

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.

CMS to cross threshold of obesity drug coverage

Wed, 24 Dec 2025 12:00:00 -0500

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 faced traditional, novel payment policies in 2025

Tue, 23 Dec 2025 11:00:00 -0500

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.

White House continues to stomp down on US drug prices – for some

Mon, 22 Dec 2025 12:00:00 -0500

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.

MAC attack on CPT code for hypoglossal nerve stimulation dings Inspire

Mon, 22 Dec 2025 11:00:00 -0500

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.

DOJ arrests shed light on Medicare skin substitute controversy

Wed, 17 Dec 2025 11:00:00 -0500

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.

Edwards seeks a TAVR two-fer in Medicare coverage petition

Tue, 16 Dec 2025 11:00:00 -0500

Edwards Lifesciences Corp., of Irvine, Calif., petitioned the Centers for Medicare & Medicaid Services to revise the Medicare coverage policy for transcatheter aortic valve replacement (TAVR) devices on two points, the combination of which would make a big difference for TAVR devices across manufacturers. Edwards requested that CMS explicitly cover TAVR for asymptomatic aortic stenosis patients, a notion well supported by recent data, and bring an end to the coverage with evidence development mandate.

US senators want the lowdown on Trump biopharma pricing deals

Mon, 15 Dec 2025 12:00:00 -0500

A group of eight Democratic senators is asking biopharma companies to spill the beans about their private most-favored-nation pricing deals with U.S. President Donald Trump. Led by Sen. Ron Wyden, D-Ore., ranking member of the Senate Finance Committee, the senators sent letters Dec. 11 to Astrazeneca plc, Eli Lilly and Co., Novo Nordisk A/S and Pfizer Inc. seeking the details of those deals. While it’s difficult to discern how the deals will benefit patients, it’s clear the companies stand to gain a lot from the agreements, the letter asserted.

Medicare’s competitive bidding program draws opposition

Tue, 02 Dec 2025 11:00:00 -0500

The U.S. Centers for Medicare & Medicaid Services has posted the home health final rule for calendar year 2026 and has established a framework for competitive bidding for products such as continuous glucose monitors, a move that is struggling to find support among stakeholders.

Gimme shelter: Neurocrine, Lilly spared in CMS price cut fallout

Wed, 26 Nov 2025 12:00:00 -0500

The U.S. Centers for Medicare & Medicaid Services (CMS) rolled out negotiated costs of the second batch of drugs subject to such bargaining under the Inflation Reduction Act. Wall Street was not surprised to learn that the numbers amount to much greater cuts than the Biden administration managed for 2026. CMS said the adjusted maximum fair prices would have achieved 44% lower net spending had they been implemented in 2024 – 36% if forgiven discounts from the part D redesign of the Medicare prescription drug benefit are figured in. Fifteen drugs are listed.