GOP: Obamacare hitting seniors hard

GOP: Obamacare hitting seniors hard-politico: Republican Rep. Tom Rooney of Florida took aim today at Obamacare’s impact on older Americans, saying that seniors across the country are paying “more money for fewer choices, less access and far less peace of mind.” In the GOP’s weekly address, Rooney castigated President Barack Obama’s very public pledge that Americans of all ages would be able to keep their doctors under the health law. Since the fall, the president has had to backtrack on that statement, acknowledging that the law was forcing changes in insurance plans that meant some people were losing their physicians.

Lawmakers Urge RAC Changes As Watchdogs Seek Reversal Of Program Limits

Lawmakers Urge RAC Changes As Watchdogs Seek Reversal Of Program Limits-insidehealthpolicy: A bipartisan group of over a hundred lawmakers, led by Reps. Sam Graves (R-MO) and Adam Schiff (D-CA), is urging HHS to reform its Recovery Audit Contractor program – including changing payment methods – and pointing to the two-year backlog at the third level of the appeals system as consequence of current problems with the program. The lawmakers' request comes shortly after Citizens Against Government Waste pushed lawmakers to reinstate the RAC audits that CMS limited when instituting the two-midnights inpatient admission policy.

FDA Requires Electronic Submission Of Adverse Event Reports By August 2015

FDA Requires Electronic Submission Of Adverse Event Reports By August 2015-thegraysheet: Beginning 18 months from now, medical device manufacturers will be required to submit their adverse event reports to FDA electronically, instead of on paper. The new requirement applies to all device manufacturers and importers, regardless of their size. It goes into effect on Aug. 14, 2015. The details are spelled out in a final rule (PDF) issued by the agency Feb. 13.

Summer Sunshine: CMS Pushes Open Payments Deadline To June Or Later

Summer Sunshine: CMS Pushes Open Payments Deadline To June Or Later-thegraysheet: Device makers will have until at least June to register in CMS’ Open Payments system and submit detailed 2013 physician payment data, but they will need to submit aggregate payment data by March 31. CMS announced the new timeline Feb. 7 amid questions and confusion from stakeholders about whether CMS expected companies to submit data for the 2013 program year by March 31, as it states in the final rule released last February, or per other communications from the agency that suggests firms would have 90 days from when CMS opened the registration process. 

U.S. medical device regulator to improve PMA, IDE processes

U.S. medical device regulator to improve PMA, IDE processes-massdevice: The US Food and Drug Administration's Center for Devices and Radiological Health (CDRH) plans revisions to its Investigational Device Exemption process to improve clinical trial management for manufacturers and sponsors, and may also consider down-classifying some devices from Class III Premarket Approval registration requirements.

Device Center Moves To Better Prioritize Its Scientific Work

Device Center Moves To Better Prioritize Its Scientific Work-thegraysheet: FDA’s device center has created a Regulatory Science Subcommittee to identify and prioritize scientific needs, and the Office of Science and Engineering Laboratories is considering restructuring to enhance its responsiveness to regulatory science issues. These are just two changes afoot at CDRH in response to recommendations in a report written by the FDA Science Board’s CDRH Research Review Subcommittee and approved by the full Science Board last June.

To work or not to work? Hearing looks at Obamacare’s influence

To work or not to work? Hearing looks at Obamacare’s influence-politico: Is it always bad to discourage people from working? That was the hotly debated question Wednesday morning at the House Budget Committee, where members quizzed Congressional Budget Office Director Doug Elmendorf on his agency’s latest economic report. The report, which projected that Obamacare will cause Americans to work fewer hours, sparked intense partisan debate over whether the health care law will deprive people of jobs they need — or whether it’s simply freeing them from jobs in which they wouldn’t have otherwise stayed but for health benefits.