Centers for Medicare and Medicaid Services (CMS) Archives - Page 4 of 4

Boston Scientific stent gains added Medicare coverage

Boston Scientific (NYSE:BSX) announced today that CMS granted a new technology add-on payment (NTAP) for its Eluvia system.

Marlborough, Mass.-based Boston Scientific’s Eluvia drug-eluting vascular stent system received the NTAP as part of the 2021 inpatient prospective payment system (IPPS). The NTAP will be made effective on Oct. 1, 2020, to provide eligible hospitals with incremental reimbursement for Eluvia for up to three years, according to a news release.

Eluvia treats peripheral artery disease (PAD) by reopening the blocked artery and restoring blood flow while also utilizing a drug-polymer combination to offer a sustained, low-dose drug release to prevent tissue regrowth within the stented artery.

“The CMS determination is a very positive development for patients with PAD and supports what we have confirmed through our clinical trials – the Eluvia stent offers clinically superior outcomes compared to other peripheral drug-coated tech…

CMS rate cuts for Abiomed Impella not as bad as expected

This illustration shows the Impella 5.5 with SmartAssist placed in the heart. [Image courtesy of Abiomed]

CMS will pay 11% less for the tiny Impella heart pump made by Abiomed (NSDQ:ABMD) during the upcoming federal fiscal year — but the reduction is better than the 24% cut originally proposed.

For the federal fiscal year ended Sept. 30, 2021, the rate for uni-ventricular Impella percutaneous insertion will be $71,950, down from the previous $80,650.

Analysts at Jefferies in a note today said they expect the impact on utilization to be minimal.

CMS acknowledged the magnitude of the cut it originally proposed, according to the Jefferies analysts. They added that the largest healthcare payer in the U.S. is looking at fixes going forward to stabilize Impella reimbursement.

ABMD shares are down 4.5% to $298.73 apiece in morning trading today. MassDevice’s MedTech 100 Index, which includes …

Viz.ai stroke software lands Medicare ‘new technology’ coverage

The Centers for Medicare and Medicaid Services (CMS) has granted Viz.ai the first New Technology Add-on Payment (NTAP) for artificial intelligence software, the company announced today.

NTAP, part of the CMS inpatient prospective payment system, was set up to support the adoption of cutting-edge technologies that have demonstrated substantial clinical improvement and ensure early availability to Medicare patients. Viz.ai’s flagship product, Viz LVO, uses deep learning to communicate time-sensitive information about stroke patients to a specialist who can intervene and treat.

Get the full story on our sister site, Medical Design & Outsourcing.

Abbott wins Medicare reimbursement for FreeStyle Libre 2

Abbott (NYSE:ABT) announced today that its next-generation FreeStyle Libre 2 iCGM is now available to Medicare patients.

The integrated continuous glucose monitoring (iCGM) system met the codes for therapeutic CGM systems used for coverage by the U.S. Centers for Medicare & Medicaid Services (CMS), making it accessible to all Medicare patients with diabetes who meet the eligibility criteria, according to a news release.

Get the full story at our sister site, Drug Delivery Business News.

Abbott wins Medicare reimbursement for FreeStyle Libre 2

Abbott (NYSE:ABT) announced today that its next-generation FreeStyle Libre 2 iCGM is now available to Medicare patients.

The integrated continuous glucose monitoring (iCGM) system met the codes for therapeutic CGM systems used for coverage by the U.S. Centers for Medicare & Medicaid Services (CMS), making it accessible to all Medicare patients with diabetes who meet the eligibility criteria, according to a news release.

Abbott Park, Ill.-based Abbott’s FreeStyle Libre 2 includes a sensor worn on the back of the upper arm for up to 14 days, using a handheld reader over the sensor to provide real-time glucose readings, trend arrows and eight-hour history to help healthcare providers and users make informed treatment decisions.

The system also includes real-time alarms and minute-by-minute glucose measurements, while Abbott touts it as the longest-lasting self-applied iCGM sensor currently available, eliminating the need for fingersticks and costi…

CMS agrees to cover ‘breakthrough’ medical devices

Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under a proposed rule released this morning.

Once the Medicare Coverage of Innovative Technology (MCIT) final rule goes into effect, national Medicare coverage will begin on the date of a breakthrough device’s FDA market authorization would begin and continue for 4 years.

The proposed rule, scheduled to be published September 1 in the Federal Register, has been under discussion for years and would remedy a nationwide patchwork of Medicare coverage for such devices. Currently, a breakthrough device may be covered in one state or area of a state and not another, depending upon a local coverage determination made by a Medicare administrative contractor.

The MCIT pathway would be voluntary and device manufacturers would notify the Centers for Medicare and Medicaid Services if they want to use this coverage option.

“This coverage pathway d…

CMS pushes for return to essential kidney treatments, transplants

The Centers for Medicare & Medicaid Services (CMS) has announced updated guidance urging for the resumption of kidney procedures.

CMS said its guidance is designed to ensure medical providers can able return to offering essential surgical, life-sustaining procedures while reinforcing infection control precautions at dialysis facilities in COVID-19 hotspots.

The guidance includes a checklist of actions for the facilities to take when there is a surge or resurgence of the virus in the surrounding community, as well as the suggestion that the providers resume the planned surgical procedures whenever possible.

CMS previously released guidance suggesting that providers defer nonessential planned procedures in response to the ongoing COVID-19 pandemic, but Monday’s update to the guidance clarified that essential procedures, such as vascular access and organ transplants, are critical, life-sustaining treatments.

The agency added that providers…

CMS proposes coverage updates that could increase access to VADs

Abbott’s HeartMate 3 LVAD [Image courtesy of Abbott]

The Centers for Medicare & Medicaid Services (CMS) today proposed coverage policy updates meant to increase access to VADs and artificial hearts.

The policy updates, if approved, could be good news for major VAD makers Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) — as well as people with heart failure who are waiting for a heart transplant or don’t meet the criteria for one.

“CMS’ proposed revisions to its national coverage determination (NCD) for ventricular assist devices are very promising for people living with advanced heart failure. Providing patients with greater access to this technology is important as heart pumps can have a critical impact on saving and improving quality of life. We look forward to CMS’ final decision in the months ahead,” Dr. Robert L. Kormos, divisional VP of global medical affairs for Heart Failur…

Abbott, Medtronic go head-to-head at ADA conference

Major medtech companies vied for the biggest news splash at this year’s annual meeting of the American Diabetes Association, announcing promising results from studies of patients who used their latest diabetes technology.

The virtual 80th Annual American Diabetes Association Virtual Scientific Sessions, which runs through Tuesday, so far has featured news out of Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) and several smaller companies as well as studies showing how diabetes tech is helping diverse patient populations. More than 800 sessions have been planned.

Here are some of the highlights of this year’s conference, which began June 12.

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CMS releases guidance on resuming elective procedures

The Centers for Medicare & Medicaid Services (CMS) issued guidelines for non-emergent, non-COVID-19-related healthcare as facilities reopen.

In March, CMS recommended that healthcare providers postpone elective procedures until further notice to preserve personal protective equipment. An April 16 White House recommendation gave the green light for elective surgical procedures to resume.

CMS now says, in a notice dated June 8, that facilities should check with state and local authorities to confirm if gating criteria (symptoms, cases and hospitals) have been met in their area. For states with no evidence of meeting gating criteria, CMS recommends optimizing telehealth and continued shelter in place for individuals at higher risk for COVID-19.

For healthcare systems that are opening, CMS said facilities must preserve the capacity to care for potential surges of COVID-19 patients and the fluctuations of COVID-19-related needs.

The CMS guidance sa…

Nuvaira gains FDA breakthrough nod for lung denervation system

Obstructive lung disease treatment developer Nuvaira said today that the FDA has designated its lung denervation system a breakthrough device.

The Nuvaira lung denervation system enables a novel bronchoscopic procedure that disrupts pulmonary nerve input to the lung to reduce the clinical consequences of neural hyperactivity, which causes airway hyper-responsiveness or “lung attacks” in both COPD and asthma.

The system is designed to reduce the risk of worsening moderate-to-severe chronic obstructive pulmonary disease (COPD) in patients on optimal medical care, according to Minneapolis-based Nuvaira. In March, the FDA’s review of safety data on the first 50 patients enrolled in Nuvaira’s Airflow-3 pivotal trial resulted in FDA investigational device approval for the company to complete the 400-patient study, Nuvaira noted. In April, the Centers for Medicare & Medicaid Services (CMS) approved Medicare coverage of the Airflow-3 trial.<…

CMS moves to boost access to Boston Sci’s single-use duodenoscope

The Exalt Model D single-use duodenoscope from Boston Scientific [Image courtesy of Boston Sci]

Boston Scientific (NYSE:BSX) announced today that CMS will speed up Medicare beneficiaries’ access to single-use endoscopes, including Boston Sci’s Exalt Model D single-use duodenoscope.

The Centers for Medicare & Medicaid Services (CMS) granted a Boston Sci application for a plication for a transitional pass-through (TPT) payment category — an only months-old payment category meant to provide people with access to innovative medical technologies while needed cost data is collected.

Single-use duodenoscopes matter. The devices provide a less invasive way than traditional surgery to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other gastrointestinal conditions. But reprocessing the scopes has proved especially tricky — with the scopes in the past conne…