Category: U.S. House of Representatives
FDA medical device chief Jeffrey Shuren spars with the House Energy & Commerce Committee's subcommittee on Health over the FDA's proper role in regulating mobile health and medical applications.
The conversation got a bit heated this week as the House Energy & Commerce Committee's subcommittee on Health sparred with FDA medical device chief Jeffrey Shuren over regulation of mobile medical and healthcare applications.
A bipartisan group of House Reps introduces a new bill that would limit keep the FDA's mHealth oversight of out of software that is a component of a regulated medical device.
A new House bill co-sponsored by a bipartisan group of lawmakers aims to cut deep into the FDA's newly finalized oversight of mobile medical apps, keeping regulation only to programs that complement medical technologies or those that turn a mobile device into a medical one.
Senate Health Committee chairman Tom Harkin (D-Iowa) lambastes the medical device industry's efforts to repeal the 2.3% sales tax created by the Affordable Care Act, saying that the levy "won't hurt them one bit."
MASSDEVICE ON CALL — Medical device tax repeal efforts have made friends across party lines and in both houses of Congress, but Senate Health Committee chairman Tom Harkin isn't one of them.
In harsh comments made yesterday Harkin characterized the debate over the medical device tax as a fabricated controversy, saying that the industry can afford to pay its share to help fund healthcare reform, Minnesota Public Radio reported.
Senate Majority Leader Harry Reid (D-Nev.) balks at efforts to wedge a medical device tax repeal bill into the latest efforts to pass a continuing resolution that would avoid defunding.
Senate Majority Leader Harry Reid (D-Nev.) stumbled over his own words when rejecting efforts to repeal the medical device tax, calling the levy itself "stupid" and taking it back immediately.
His comments suggested a bubbling frustration as the government attempts to find ways to avoid impending shutdown, with latest efforts hinging on a 1-week continuing resolution that would give lawmakers a small stay of execution to work out a deal before they lose funding.
House speaker John Boehner warns hard-line healthcare reform de-funders against extreme measures that could spur a public backlash.
MASSDEVICE ON CALL — House speaker John Boehner warned hard-line GOP members who want to defund healthcare reform not to go through with their dramatic gestures.
Speaking to his cohorts last week, Boehner warned that holding federal functions hostage to healthcare reform negotiations could result in backlash from the public. Boehner issued his advice after receiving a letter with signatures from 80 Republicans in Congress urging him to block Obamacare at all costs.
A bipartisan bill would make changes to the False Claims Act, aiming to protect hospitals from being penalized for honest billing mistakes.
MASSDEVICE ON CALL — The False Claims Act gives federal authorities broad power to open an investigation for Medicare and Medicaid billing fraud, but a new bill would give hospitals an extra layer of protection.
The bipartisan legislation introduced in the U.S. House of Representatives last week would set up several procedural steps before the U.S. Justice Dept. or another federal agency can charge for fraud, shielding hospitals from costly legal consequences for honest billing mistakes.
House Republicans propose a new way to reimburse doctors that would repeal Medicare's sustainable growth rate equation and stem a 25% cut in reimbursement.
MASSDEVICE ON CALL — House GOP-ers are looking to rewrite the so-called "doc fix," replacing Medicare's sustainable growth rate fomula with a physician performance incentive program.
The 70-page proposal claims to improve quality and efficiency in the healthcare system with a physician reimbursement system that would start with 5 years of consistent Medicare payments.