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BioWorld - Monday, March 16, 2026
Home » Topics » Regulatory » CMS

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Cardiology societies laud Medicare coverage of EP procedures at ASCs

Nov. 26, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services will cover certain cardiac electrophysiology procedures in ambulatory surgical centers in 2026. This change which drew the support of both the Heart Rhythm Society and the American College of Cardiology, which could increase device utilization.
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CMS logo and website

CMS terminates Treatment Choices model in ESRD final rule

Nov. 25, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services ended the Treatment Choices model under the end stage renal disease payment payment system for several reasons, including its failure to deliver meaningful savings.
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CMS logo and website

CMS finalizes plan to do away with inpatient-only list

Nov. 24, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services released the 1657-page final rule for inpatient payment for calendar year 2026, a document chock full of important policy decisions including a renewed call for elimination of the inpatient-only list.
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US Capitol at night

PAMA cuts for clinical lab testing averted, but overhang remains

Nov. 20, 2025
By Mark McCarty
The resolution of the budget impasse between Democrats and Republicans on Capitol Hill sidestepped a number of problems, including some cuts to Medicare payment rates for clinical laboratory testing services. However, that pause is only in effect through the end of January 2026, leaving operators of these labs with a fiscal sword of Damocles to manage.
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Money and pills

Partisan rhetoric heats up in Rx price-lowering jousting

Nov. 19, 2025
By Mari Serebrov
No Comments
In a verbal sparring over who can deliver the lowest drug prices in the U.S., several Senate Democrats are urging President Donald Trump to immediately release the list of second-round Medicare-negotiated drug prices, instead of doing what they characterize as “ambiguous” and “opaque” pricing deals with individual biopharma companies.
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CMS logo and website

WISeR model said to create incentives to deny claims

Nov. 17, 2025
By Mark McCarty
The Medicare Wasteful and Inappropriate Service Reduction (WISeR) proposal is designed to tamp down on waste, fraud and abuse in the Medicare program, but Jeff Wurzberg, a partner at Norton Rose Fulbright LLP, told BioWorld that the contractors developing these AI models have incentives to return non-covered determinations for services.
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Wegovy and Zepbound autoinjectors

Lilly, Novo MFN deals expected to ‘democratize’ obesity drugs

Nov. 6, 2025
By Mari Serebrov
No Comments
Hailing it as a win-win and a historic step forward in fighting chronic disease, the Trump administration announced pricing agreements Nov. 6 with Eli Lilly and Co. and Novo Nordisk A/S that will expand the availability of the companies’ weight loss drugs by cutting prices and, for the first time, providing coverage for the drugs in obesity through Medicare and Medicaid.
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3-30-Medtronic-Symplicity-Spyral.png

CMS reduces required term of medical therapy in RDN final memo

Nov. 5, 2025
By Mark McCarty
The U.S. CMS has confirmed that it will cover renal denervation as a treatment for hypertension in a final coverage memo that largely mirrors the July 2025 draft. One key difference, however, is that Medicare beneficiaries are eligible for RDN after only six weeks of optimized medical therapy, half the three-month waiting period described in the draft.
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Medicare puzzle

Impulse Dynamics scores big win via Medicare coverage for CCM

Nov. 4, 2025
By Mark McCarty
Impulse Dynamics Inc. snared an affirmative Medicare coverage policy for its Optimizer cardiac contractility modulation (CCM) system, giving the company sole possession of the U.S. marketplace for this therapy at least for the time being.
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Medicare puzzle

Skin substitutes take a hit in Medicare doc fee final for 2026

Nov. 3, 2025
By Mark McCarty
The U.S. CMS has adopted an aggressive payment policy for skin substitutes in the Medicare physician fee schedule for 2026, although the payment rate is sufficiently higher than the agency had proposed to mollify some critics.
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