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BioWorld - Friday, March 27, 2026
Home » Topics » Regulatory » CMS

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Patients to payers: Can you hear me now?

Nov. 22, 2019
By Mari Serebrov
Patient engagement has become more than a buzzword for the FDA and drug and device developers. But for payers, not so much. When valuing new drugs and devices, payers often undervalue or ignore what they may consider convenience updates, giving little to no consideration to the difference a seemingly minor improvement could make to patients debilitated by fatigue, pain, the burden of treatment and the burden of a disease itself.
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CMS backs away from rate cuts for PET in CY 2020 doc fee final

Nov. 6, 2019
By Mark McCarty
The U.S. Centers for Medicare and Medicaid Services (CMS) has decided against a series of rate cuts for PET imaging in the Medicare physician fee schedule for 2020, a move lauded by physicians who were facing a rate cut of as much as 80% for nuclear medicine and molecular imaging procedures.
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CMS drops references to late-stage cancers in draft rewrite of NGS coverage memo

Oct. 31, 2019
By Mark McCarty
The U.S. Centers for Medicare and Medicaid Services (CMS) has posted a draft rewrite of the coverage memo for next-generation sequencing (NGS), and while the draft rewrite fails to address a number of concerns, the agency eliminated references to advance-stage cancer, opening the door to considerably greater utilization.
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Bipartisan group of legislators push back on cuts to PET imaging

Oct. 7, 2019
By Mark McCarty
A bipartisan group of 43 members of the U.S. House of Representatives has inked a letter to the U.S. Centers for Medicare and Medicaid Services (CMS), objecting to planned Medicare cuts for myocardial positron emission tomography (PET) imaging. The letter argues that the proposed rate cut of 72% would hamper access to a procedure that is typically provided in physician offices – and puts the onus on the CMS to justify the rate cut.
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Trump promises quicker Medicare coverage for breakthrough technologies

Oct. 4, 2019
By Mari Serebrov

Advamed urges CMS to form Medicare advisory panel for digital health

Oct. 3, 2019
By Mark McCarty
Medicare coverage of digital health is evolving, but there are those who have argued that the U.S. Centers for Medicare and Medicaid Services (CMS) is moving too slowly to capitalize on significant opportunities. The Advanced Medical Technology Association (Advamed) said in comments to the docket for the draft physician fee schedule that an advisory panel should be regularly convened in order to exploit the potential for digital health to "transform the delivery of care and improve patient care outcomes."
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MDMA cites class effect for safety in comments to Medicare outpatient draft

Oct. 1, 2019
By Mark McCarty

Stakeholders resistant to participation mandate in radiation oncology APM

Sep. 18, 2019
By Mark McCarty
The Medicare radiation oncology alternative payment model is yet another attempt to control Medicare spending growth, but provider groups and device makers oppose mandatory program participation. Varian Medical offered a blistering critique of the participation mandate, stating that the participation mandate suggests that the U.S. Centers for Medicare and Medicaid Services (CMS) is less interested in a valid test of the program than it is in generating immediate savings.
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Doc fee draft boosts telemedicine, but hits new oncology drugs

July 16, 2018
By Mark McCarty
The draft Medicare physician fee schedule (MPFS) is always an event for makers of drugs and devices, and this year is no exception. This time, the draft proposes non-controversially to formalize the specialty practice of heart failure and transplant cardiology, a move that was anticipated. While telehealth would enjoy a renewal of momentum under the terms of the draft, novel oncology drugs would be reimbursed at the wholesale acquisition cost plus 1.35 percent, a considerable shave from the current standard of WAC+6.
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Pay-and-chase back in play in new OIG report on telehealth

April 20, 2018
By Mark McCarty
Medicare coverage of telehealth, which is critical for many patients with implanted cardiac electrophysiology devices, has been slow in coming, but a new report on Medicare payments for telehealth recommends that the CMS review paid claims to claw back some instances of overpayment, which would constitute yet another example of the pay-and-chase paradigm that has drawn criticism in the past.
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