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Home » Topics » Regulatory » CMS

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US CMS eyes coverage of home dialysis for acute kidney injury

July 9, 2024
By Mark McCarty
The U.S. Medicare draft prospective payment system for end-stage renal disease encodes a few changes that will cheer industry, including a provision that would increase patient access to pharmaceuticals that are available only in oral form.
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CMS logo and website

MedPAC wary of Medicare software payment in fee-for-service care

July 3, 2024
By Mark McCarty
The problems with U.S. Medicare coverage for medical software are well known, but the Medicare Payment Advisory Commission recently indicated that these problems are largely manageable for services delivered via managed care plans.
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Unwinding of Chevron could bring down HHS, FDA, CMS policies

July 2, 2024
By Mari Serebrov
The U.S. Department of Health and Human Services (HHS) and the FDA already are getting a glimpse of the post-Chevron world and how the Supreme Court’s June 28 unwinding of the 40-year-old Chevron deference could rein in agency policies that defy Congress’ expressed intent.
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Edwards EVOQUE

Edwards urges CMS to mimic TMVR coverage for Evoque

July 2, 2024
By Mark McCarty
After snaring the U.S. FDA’s approval for the Evoque tricuspid valve device, Edwards Lifesciences Corp. petitioned the Centers for Medicare & Medicaid Services for a national coverage determination for transcatheter tricuspid valve replacement devices.
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Pills, syringes, financial charts

US Medicare spending expected to skyrocket to $1.9T by 2032

June 25, 2024
By Mark McCarty
Medicare spending in the U.S. continues to climb at a worrying pace, given that policymakers are apt to respond by putting the squeeze on the doctors and hospitals that purchase and implant medical devices.
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U.S. flag, stethoscope

MDMA urges US CMS to adopt new inpatient spinal DRGs for 2025

June 24, 2024
By Mark McCarty
The annual U.S. Medicare inpatient rule typically encodes a number of proposed reassignments of procedures between diagnostic-related groups , and the draft rule for fiscal year 2025 proposes several such changes in the area of orthopedic surgeries. The Medical Device Manufacturers Association lauded the proposed changes, arguing that the existing DRG code structure has failed to keep pace with the growing number of procedures for the lumbar spine, not to mention the significant cost differential associated with each.
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Medicare puzzle

Advamed wary of US Medicare TEAM proposal for FY 2025

June 20, 2024
By Mark McCarty
The U.S. CMS has floated an alternative payment model dubbed the Transforming Episode Accountability Model for Medicare beneficiaries in fee-for-service care, but some in industry have misgivings about the proposal.
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U.S. Capitol building, Washington D.C.

US Congress revisits Medicare Advantage prior authorization

June 13, 2024
By Mark McCarty
The prior authorization practices of Medicare Advantage programs have drawn the ire of industry and physician societies alike recently, prompting the U.S. Centers for Medicare & Medicaid Services to open a request for information in January 2024. Congress seems poised to take matters into its own hands, however, with legislation that would force these plans to work to speed up these prior authorization processes, a bill that has the enthusiastic support of the Medical Device Manufacturers Association.
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Cholesterol plaque in artery

Cleerly seeks US Medicare coverage of AI-enabled plaque analysis

June 3, 2024
By Mark McCarty
New York-based Cleerly Labs Inc., petitioned several U.S. Medicare administrative contractors for coverage of the use of the company’s artificial intelligence product for analysis of CT coronary arteries to evaluate the disease burden of plaque.
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Medicare puzzle

​Abbott seeks US Medicare national coverage for Cardiomems system​

May 21, 2024
By Mark McCarty
A renewed focus on telehealth and telemedicine may be pumping new life into remote patient monitoring for heart failure, which seems to be the case for the Cardiomems device by Abbott Inc.
Read More
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