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Home » Topics » Regulatory » Legislation

Legislation
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Respironics hit with $2.5M settlement for FCA allegations

Jan. 2, 2024
By Mark McCarty
The U.S. Office of Inspector General (OIG) reported that it and Philips Respironics have come to terms over allegations that the company violated the False Claims Act (FCA) by offering free CPAP masks to operators of sleep clinics
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2023 FDLI Enforcement Conference

FDA facing a ‘somewhat unimaginable’ volume of applications for LDTs

Dec. 8, 2023
By Mark McCarty
The U.S. FDA’s draft rule for lab-developed tests (LDTs) has proven to be every bit as controversial as expected, although the controversy is only marginally about the workload that would come with rulemaking.
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U.S. Capitol building, Washington D.C.

FDA’s Califf says delays in user fee legislation could trigger layoffs

July 12, 2022
By Mark McCarty
Legislation that would renew the U.S. FDA’s user fee programs is stuck in process on Capitol Hill, a predicament that seems to resist resolution to date. FDA commissioner Robert Califf said on a July 12 webinar that the FDA “is a decision-making machine” that is reliant on both user fees and congressional appropriations, and that a failure on the part of Congress to act on user fee legislation may force the agency to halt new hires and possibly lay off some FDA staff.
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U.S. Capitol building

Skepticism of telehealth cost, utilization in the U.S. aired in hearing

March 2, 2021
By Mark McCarty
Several telehealth bills are in circulation on Capitol Hill, but U.S. federal government agencies have expressed concerns about the potential for fraud and abuse, and the impact on Medicare spending. Despite those concerns, two key members of the House Energy and Commerce (E&C) Committee, Reps. Frank Pallone (D-N.J.) and Anna Eshoo (D-Calif.), said during a March 2 hearing that they have misgivings about those cautionary views of telehealth, suggesting that any related legislation will aggressively expand Medicare coverage of telehealth.
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U.S. Capitol building

Advamed’s Van Meter: ‘Time is now to act’ on LDT regulatory reform

March 9, 2020
By Mark McCarty
The latest version of legislation for regulatory reform has arrived, and the conventional wisdom may be that the Verifying Accurate, Leading-Edge IVCT Development (VALID) Act will not be passed until the next user fee agreement is codified into law. Nonetheless, Susan Van Meter, executive director of AdvamedDx, told BioWorld that the associated reforms are urgently needed by patients and test developers alike, and there is consequently no need to wait for user fee legislation to pass the VALID Act.
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Draft proposal shows how HHS price negotiations could take shape

Sep. 11, 2019
By Mari Serebrov
Whether it's mere political posturing or a genuine prescription to control U.S. drug prices, a Democratic plan taking shape in the House provides an idea of what direct government negotiation might look like.
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Congress pushes ahead with Rx pricing bills as administration efforts founder

July 12, 2019
By Mari Serebrov
Faced with a tradeoff between low Medicare premiums that benefit all beneficiaries and lower out-of-pocket costs that benefit the sickest beneficiaries, the Trump administration chose lower premiums, sinking a proposed rule that would have pulled drug rebates from the safe antikickback harbor.
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Torching of HHS ad rule could stoke the ire over U.S. drug prices

July 10, 2019
By Mari Serebrov
The striking of a Health and Human Services (HHS) rule requiring TV ads for prescription drugs to include list prices may turn up the temperature on the political roasting of biopharma companies – and stoke the pressure for Congress to do something about those prices.
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