FDA Final Guidance For RF Wireless Devices Expands Pre-Market Recommendations

FDA Final Guidance For RF Wireless Devices Expands Pre-Market Recommendations-graysheet: FDA highlights its pre-market submission recommendations and design considerations for devices that employ radiofrequency wireless technology in a final guidance document issued Aug. 13. The guidance (PDF) applies to devices that are implanted or worn on the body, or other external wireless medical devices intended for use in hospitals, homes, clinics, clinical laboratories and blood establishments. RF wireless technologies addressed in the guidance include Wireless Medical Telemetry Service, Medical Device Radiocommunication Service, Medical Body Area Network, cellular communication chipsets and RF identification products, according to FDA.

Another Obamacare delay

Another Obamacare delay-washingtonpost: Yet another part of the unwieldy Obamacare leviathan is to be delayed, the New York Times tells us: “In another setback for President Obama’s health care initiative, the administration has delayed until 2015 a significant consumer protection in the law that limits how much people may have to spend on their own health care.”

Obamacare Foes Make Final Push To Stop Health Law's Implementation

Obamacare Foes Make Final Push To Stop Health Law's Implementation-npr: With less than eight weeks to go before the official launch of the new health care marketplaces under the federal health law, backers of the law are ramping up to encourage people to sign up. But there's another effort gearing up this month as well. Opponents of the health care law are making one last-ditch effort to run Obamacare off the rails before it gets fully implemented. Probably the most aggressive effort is coming from FreedomWorks, a conservative advocacy group. It's urging people, particularly young people, not to sign up for health insurance.

Medicare: New payment rule boosts budgets and patient safety programs

Medicare: New payment rule boosts budgets and patient safety programs-massdevice: CMS increased payment rates for inpatient stays at both general and long-term care hospitals and hones definitions for what types of situations merit hospital admission, responding to "recent concerns about extended Medicare beneficiary stays in the hospital outpatient department," according to the report.

American Heart Association: CMS Plans To Change Stroke Measures

American Heart Association: CMS Plans To Change Stroke Measures-insidehealthpolicy: The American Heart Association has a commitment from CMS and the “highest levels” of the White House to account for the severity of strokes in outcomes measures upon which hospital pay is based, AHA Vice President of Federal Advocacy Sue Nelson said, even though the final inpatient-hospital pay rule for next fiscal year did not. CMS included in the pay rule stroke outcomes-measures that a bipartisan group of lawmakers, medical groups and the National Quality Forum urged the agency to drop on the grounds that the measures do not account for the severity of strokes.

CMS Will Expedite Removal Of Outdated National Coverage Policies

CMS Will Expedite Removal Of Outdated National Coverage Policies-thegraysheet: CMS is establishing an expedited process to review long-standing national coverage determinations (NCDs) and remove those that no longer serve the Medicare program or its beneficiaries. The new administrative procedure, set to take effect Aug. 7, is described in an August 2 notice revising and clarifying its NCD processes. The notice supersedes the agency’s 2003 policy memo on the national coverage-setting procedures for Medicare.

Medical device tax repeal bill has 259 co-sponsors with more on the way

Medical device tax repeal bill has 259 co-sponsors with more on the way-massdevice: Representatives in the U.S. House are set to top last year's vote to repeal the 2.3% medical device excise tax. The "Protect Medical Innovation Act of 2013," co-sponsored by Reps. Erik Paulsen (R-Minn.) and Ron Kind (D-Wis.), has garnered 259 signatures, according to the Library of Congress' THOMAS database. Rep. Roger Williams (R-Tex.) is the latest lawmaker to add his name to the list, having signed on this week.

U.S. official challenges claim that Obamacare hurts workers

U.S. official challenges claim that Obamacare hurts workers-reuters: At a stormy House of Representatives committee hearing, Marilyn Tavenner, who heads the Medicare and Medicaid programs, said she has found only anecdotal evidence of employers reducing work hours or benefits because of worries about President Barack Obama's landmark reforms, which take effect on January 1. "I am out there. I am listening. I do hear isolated incidents of individuals trying to cut back hours," said Tavenner, who is overseeing much of Obamacare's implementation as administrator of the Centers for Medicare and Medicaid Services.

House Republicans leery of 'Obamacare' defunding idea

House Republicans leery of 'Obamacare' defunding idea- reuters: I think leadership is giving other options that they think are more effective," said Republican Representative Pat Tiberi, a close ally of House Speaker John Boehner. Tiberi, speaking to Reuters following a closed-door meeting of House Republicans, said that while a final decision probably had not been made, his colleagues are more likely to continue pushing for Congress to repeal individual provisions of "Obamacare."

House panel votes to change Medicare funding approach

House panel votes to change Medicare funding approach-washingtontimes: A key House panel unanimously approved a bill on Wednesday that would replace the formula that pays doctors for each service provided under Medicare with one that rewards providers for high-quality care — a measure that both sides of the political aisle praised as long overdue. The 51-0 vote by the Committee on Energy and Commerce sends the Medicare Patient Access and Quality Improvement Act to the full chamber.

President Obama on Hill's Obamacare mess: I'm on it

President Obama on Hill's Obamacare mess: I'm on it-politico: President Barack Obama privately told Democratic senators Wednesday he is now personally involved in resolving a heated dispute over how Obamacare treats Capitol Hill aides and lawmakers, according to senators in the meeting. The president’s commitment was delivered at the beginning of Obama’s remarks to Senate Democrats during a closed-door session.