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Home » Authors » Mark McCarty

Mark McCarty

Articles

ARTICLES

US Senate eyes two new legislative proposals for False Claims Act litigation

Aug. 7, 2023
By Mark McCarty
U.S. federal government agency recoveries under the False Claims Act (FCA) are down slightly in the first half of 2023 relative to the first half of 2022, but that doesn’t mean companies in the life sciences can afford to let their guard down. The Senate is examining two pieces of legislation that would significantly amplify the risk for device and drug makers, including a Senate bill that would eviscerate the materiality standard as set by the U.S. Supreme Court in Escobar.
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UK’s NICE eyes limited coverage of carotid artery stenting for asymptomatic patients

Aug. 7, 2023
By Mark McCarty
The U.K. National Institute for Health and Care Excellence (NICE) is considering a coverage policy for stenting of the carotid arteries in asymptomatic patients, a change that could give these stents a significantly larger patient population in the U.K.
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US FDA expands sterilization standards recognition as litigation rolls on

Aug. 4, 2023
By Mark McCarty
The U.S. FDA recognized several new standards for sterilization of medical devices as part of an effort to reduce the use of ethylene oxide (EtO) for this purpose. While the recognition may stimulate adoption of alternative methods, Congress is applying yet more pressure on the EPA to act more decisively in regulating EtO, thus amplifying pressure on a system that device makers believe is already under stress.
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Lock on digital globe illustration

New EU-US data privacy framework a positive development, but requires up-front work

Aug. 3, 2023
By Mark McCarty
The European Union and the U.S. have wrapped up a data privacy framework that covers broad swaths of both economies, including the transmission of clinical trial data across the Atlantic Ocean. Drug and device makers that want to make use of this framework and thus jettison the contractual clause to ensure data privacy may find compliance with this new framework much more efficient in the long run, but will have to do a lot of compliance work on the front end to achieve those efficiencies.
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US CMS sticks with new mandates for Medicare new technology add-on payment

Aug. 2, 2023
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) finalized the Medicare inpatient prospective payment system for fiscal year 2024 with a number of new and renewed new technology add-on payments (NTAPs) for the coming fiscal year. Controversially, however, the agency retained a proposal from the draft that requires that a product have received market authorization from the FDA by no later than May 1 of the prior fiscal year to qualify for NTAP payment, a provision that industry has blasted as exclusionary of products that merit an NTAP payment.
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Summertime blues: Baxter, Draeger and GE Healthcare hit with recalls

Aug. 2, 2023
By Mark McCarty
Device recalls pop up with no regard to human appreciation for seasonality, and thus it was that recalls involving three major medical device makers emerged as the steamy month of July gave way to the arid, oppressive swelter of August. These recalls affected more than 7,500 units of the Trusignal pulse oximeter by GE Healthcare Technologies Inc., nearly 23,000 units of the Sigma Spectrum and Spectrum IQ infusion pumps by Baxter Healthcare Corp., and an unspecified number of units of the Carina ventilator by Drägerwerk AG, all of which adds a little more than the usual heat to the device industry’s dog days.
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US FDA’s proposal to reorganize Office of Regulatory Affairs not without pitfalls

Aug. 1, 2023
By Mark McCarty
The U.S. FDA unveiled a proposal to once again reshuffle its operations, this time with a greater degree of emphasis on the function of the Office of Regulatory Affairs (ORA). Tim Philips, a consultant with Gardner Law and a former member of the FDA, told BioWorld that while these changes will likely yield some useful efficiencies, they might also dilute some of the more useful interaction between industry and FDA, a loss that may be keenly felt when it comes to matters such as FDA inspections.
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Beckman Coulter comes up short in appeal of US Army lab equipment contract

Aug. 1, 2023
By Mark McCarty
The U.S. Army needed 10 months to award a contract following a July 2022 request for proposals for flow cytometry and other clinical lab equipment, but Beckman Coulter Inc., filed an appeal that protested the award to Sysmex America Inc., of Lincolnshire, Ill. Beckman Coulter argued that Sysmex should have been disqualified from the bidding for failing to provide a technically acceptable proposal, but the Government Accountability Office decreed that the company’s protest failed because it was not filed within the required 10 days post-award.
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US SEC cybersecurity rule narrows range of information disclosed, but holds four-day mandate

July 31, 2023
By Mark McCarty
The U.S. Security and Exchange Commission’s final rule for disclosure of cybersecurity incidents would seem to weigh more heavily on device makers and their client hospitals than on other industries, particularly given that the draft rule required a four-day notification of any such events. The final rule retains that requirement to notify investors of any such breach within four days, although the SEC relented on the content of such disclosures to ease concerns about the potential for disclosures to amplify the cybersecurity threat.
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US NIH says study results lend credence to the apnea/cardiovascular risk hypothesis

July 31, 2023
By Mark McCarty
Cardiologists have debated for some time whether obstructive sleep apnea (OSA) is a proven factor in a patient’s risk for heart disease, but the U.S. National Institutes of Health says newly published studies identify the specific mechanisms for this association. The studies offered data from more than 4,500 subjects and affirms the notion that OSA-driven hypoxia correlates well with the occurrence of a primary cardiovascular event, but the NIH says these findings need to be confirmed in another trial, hopefully one with enrollees whose OSA is deemed a high-risk version of the condition.
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