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Home » Topics » Regulatory » CMS

CMS
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U.S. Capitol building
Support for NIH boost still strong

DeLauro says House, Senate leaders agree on coronavirus supplemental

March 4, 2020
By Mark McCarty
The March 4 congressional hearing on the budget for the NIH was peppered with questions about the COVID-19 outbreak, although the general sentiment is that the agency will receive yet another boost in appropriations in fiscal 2021.
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Orthopedics implants, joint-replacements

CMS adds three years to joint replacement demo, but device makers at low risk

Feb. 21, 2020
By Mark McCarty
The U.S. Centers for Medicare and Medicaid Services (CMS) announced it may tack on another three years to the Comprehensive Care for Joint Replacement (CJR) program, proposing among other things to drop the 50% cap on gainsharing payments. Analysts with Cowen Washington Research Group, of New York, said post-acute care providers are at greater risk than device makers with the extension, however, due to the fact that hospitals have several choices in terms of discharge destination, including the patient’s home.
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Map of Europe

MDMA’s Leahey says harmonization great, but EU transition a more pressing concern

Feb. 20, 2020
By Mark McCarty
The 2.3% medical device tax is a thing of the past, and now Medicare coverage is one of the issues that is front and center for the Medical Device Manufacturers Association. MDMA President and CEO Mark Leahey told BioWorld also that while member companies are keen on regulatory harmonization, the struggles in standing up the new European regulatory framework is a far more pressing concern.
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Medicare puzzle

Abbott urges CMS to rethink coverage for ventricular assist devices

Feb. 5, 2020
By Mark McCarty
Medicare coverage of ventricular assist devices assumes the patient is either in end-stage heart failure or could become a candidate for transplant, but that approach may soon change. Abbott Laboratories, of Abbott Park, Ill., has asked that Medicare coverage assume the patient can recover myocardial function, a paradigm shift that is backed by clinical evidence.
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Blue heart and data grid

CMS eyes Syncardia petition to drop CED for artificial hearts

Feb. 4, 2020
By Mark McCarty
Syncardia Systems LLC, of Tucson, Ariz., has petitioned the Centers for Medicare and Medicaid Services (CMS) to drop the coverage with evidence development (CED) mandate for artificial hearts, stating that multiple studies have demonstrated that artificial hearts meet the reasonable and necessary standard. Syncardia said its temporary Total Artificial Heart (TAH-t) should thus be available “unencumbered by the existing requirement for evidence development,” a change that could modestly bolster utilization and sales of these devices.
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DNA NGS genome sequencing

CMS loosens restrictions on next-gen sequencing in coverage memo update

Jan. 28, 2020
By Mark McCarty
The U.S. Centers for Medicare and Medicaid Services (CMS) has significantly relaxed the national restrictions on coverage of next-generation sequencing for cancer, affirming that early-stage breast and ovarian cancer patients will be covered. However, Medicare administrative contractors can cover tests that have not been reviewed by the FDA, a move that should also significantly boost utilization for makers of next-generation sequencing systems in clinical labs.
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Jenavalve snares breakthrough device designation for flagship TAVR device

Jan. 9, 2020
By Mark McCarty
Jenavalve Technology Inc., of Irvine, Calif., has won an FDA breakthrough device designation for its namesake transcatheter aortic valve replacement device, but Jenavalve said it will file for a humanitarian device exemption in the second half of 2020, suggesting that the device won’t be commercially available for at least another year.
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Attorneys say final rules for Stark, AKS drafts unlikely to emerge this year

Jan. 6, 2020
By Mark McCarty
The draft rules for the Stark and Anti-Kickback statutes (AKS) seem to have excluded makers of devices, but Meena Datta of Sidley Austin told BioWorld MedTech that while these agencies have plenty of reasons to rethink that notion, the final rules are unlikely to emerge in 2020 simply because of the complexity of the undertaking. While the final rules may reverse the drafts’ exclusion of makers of devices and diagnostics, device makers were upbeat at the prospect that they could engage in value-based payment arrangements with providers.
Read More
U.S. flag on columned building

Premier recommends device, drug makers be included in OIG’s anti-kickback draft

Dec. 23, 2019
By Mark McCarty
The exclusion of makers of devices and drugs from a proposed overhaul of the Anti-Kickback Statute (AKS) probably took many in industry by surprise, but Premier Inc., of Charlotte, N.C., argued that this approach fails to capitalize on an opportunity to hold manufacturers accountable for clinical outcomes in value-based arrangements.
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CMS OKs coverage for Pq Bypass TORUS 2 study

Dec. 20, 2019
By Meg Bryant
Pq Bypass Inc., of Milpitas, Calif., said that the Centers for Medicare and Medicaid Services (CMS) has agreed to cover its TORUS 2 investigational device exemption (IDE) clinical trial, which is evaluating the Torus stent graft in the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA).
Read More
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