Wednesday, July 31, 2013

'Obamacare' mandate delay will cost $12 billion, affect 1 million workers

'Obamacare' mandate delay will cost $12 billion, affect 1 million workers-reuters: President Barack Obama's decision to delay implementation of part of his healthcare reform law will cost $12 billion and leave a million fewer Americans with employer-sponsored health insurance in 2014, congressional researchers said Tuesday. The report by the non-partisan Congressional Budget Office is the first authoritative estimate of the human and fiscal cost from the administration's unexpected one-year delay announced July 2 of the employer mandate - a requirement for larger businesses to provide health coverage for their workers or pay a penalty

A government shutdown won’t stop Obamacare

A government shutdown won’t stop Obamacare-washingtonpost: Congressional Republicans are debating whether to pass budget legislation that would cut off Obamacare funding. That could lead to a government shutdown, unless President Obama decided to sign off on a bill cutting off money for his signature legislative accomplishment (spoiler alert: This is unlikely!).


GLAXO CASE SHINES LIGHT ON CHINA'S MEDICAL BRIBERY

GLAXO CASE SHINES LIGHT ON CHINA'S MEDICAL BRIBERY-associatedpress: Many blame a system in which the country's hospitals nearly all are state-run but get too little money from Beijing. Most of China's 2.3 million doctors are hospital employees and are barred from adding to their income by taking on second jobs. "Physicians are way underpaid and they need to find a way to survive," said Gordon Liu, a health care economist at Peking University's Guanghua School of Management.

CDRH Outlines New System For Tracking IDE-Related Submissions

CDRH Outlines New System For Tracking IDE-Related Submissions-thegraysheet: A new system for processing investigational device exemption submissions will allow CDRH to track multiple studies of the same device, including feasibility and pivotal trials, under a single IDE submission number. The changes to the IDE submission structure will take effect Aug. 18, FDA announced July 29. Each subsequent submission to an original IDE submission will be assigned to the appropriate study so FDA can track milestones in clinical trial development, IDE approval, study initiation and study completion, the agency said.

'Sunshine-ing' on Docs Signals End to Pharma Largesse

'Sunshine-ing' on Docs Signals End to Pharma Largesse-medpage: Starting Thursday, drug and device manufacturers and group purchasing organizations must report payments or gifts in excess of $10 made to physicians in a yearly basis under the Physician Payments Sunshine Act. Those payments will be displayed on a public website starting next fall.

Monday, July 29, 2013

Obama Intends to Let Health Care Law Prove Critics Wrong by Succeeding

Obama Intends to Let Health Care Law Prove Critics Wrong by Succeeding-newyorktimes: The president accused Republicans of “all kinds of distortions” about the legislation. He said bluntly that his administration had a simple plan to build support for the law, which continues to be viewed with suspicion by large numbers of Americans. “We’re going to implement it,” he said.


The Hype Over Hospital Rankings

The Hype Over Hospital Rankings-newyorktimes: What’s more, Dr. Osborne compared the outcomes of two ranking programs — one by U.S. News and World Report and the other by Healthgrades — and found a “large discordance” in their results. “The two biggest rating systems come up with completely different lists,” he said. “What does that tell you?” If such advertising often adds little in the way of useful information, it certainly adds to health care costs. Hospitals with more than 400 beds spent an average of $2.18 million on advertising in 2010, surveys have found.

Friday, July 26, 2013

Sequestration should not slow American access to new medications

Sequestration should not slow American access to new medications-thehill: Imagine an industry constructively working with a government agency for nearly two years to identify needed improvements to its processes to better serve Americans. Now, imagine the industry offering to help pay for the improvements. And, finally, in today’s hyper-partisan atmosphere, imagine Congress voting, with overwhelming support from Republicans and Democrats alike, to pass that agreement into law. A case study in how D.C. should work, right? Well… not so fast.

Thursday, July 25, 2013

Ways and Means Democrats to Camp: Include us

Ways and Means Democrats to Camp: Include us-politico: Camp has promised to pass tax reform legislation in the committee by the end of this year and that leaves a very small window for the legislation to be written, considered and approved. But lawmakers are scheduled to leave town next week for a month-long recess. Some Democrats worry that the long break will give Republicans a chance to box them out of the discussion.

Don’t Shift Payments by Medicare, Panel Says

Don’t Shift Payments by Medicare, Panel Says-washingtonpost: WASHINGTON — Adjusting Medicare payments to reward doctors and hospitals in regions that provide high-quality care at low cost would be a bad idea, the National Academy of Sciences said Wednesday. After a three-year study, the academy’s Institute of Medicine rebuffed arguments by members of Congress from states like Minnesota and Iowa who say Medicare has shortchanged their health care providers for decades.

Can hackers and medical device makers play nice?

Can hackers and medical device makers play nice?-massdevice:  Few medical device companies have talked openly about their cybersecurity concerns or strategies, but the "hacker" community is less subtle, taking their concerns to the public at conferences, through federal agencies and through contact with the media, forcing a sometimes tenuous partnership.

Monday, July 22, 2013

How a secretive panel uses data that distort doctors’ pay

How a secretive panel uses data that distort doctors’ pay-washingtonpost: Unknown to most, a single committee of the AMA, the chief lobbying group for physicians, meets confidentially every year to come up with values for most of the services a doctor performs. Those values are required under federal law to be based on the time and intensity of the procedures. The values, in turn, determine what Medicare and most private insurers pay doctors

Ways & Means Draft Medicare Bill Adds Home Health Copay, Hikes Part D&B Cost Sharing

Ways & Means Draft Medicare Bill Adds Home Health Copay, Hikes Part D&B Cost Sharing-insidehealthpolicy: House Ways and Means Republicans released draft legislation Friday (July 19) increasing the income-related premiums for Medicare Parts B and D, increasing the annual Medicare Part B deductible, and creating a copay for home health, though Chairman Dave Camp's (R-MI) staff told other congressional offices in an email obtained by Inside Health Policy that “these policies are from the 2014 President's budget and are not the position of the Ways and Means Committee.”


Tuesday, July 16, 2013

CMS Expected To Detail Pioneer ACO 1st Year Performance, Dropouts On Tuesday

CMS Expected To Detail Pioneer ACO 1st Year Performance, Dropouts On Tuesday-insidehealthpolicy: CMS is expected to announce on Tuesday (July 16) the performance results for the first year of the pioneer ACO demonstration and the number of accountable care organizations dropping out of the demo, physician lobbyists say. CMS has touted ACOs as one of the most promising changes to how health care is delivered, and providers say the results will offer the first indication of how the best, most integrated organizations are handling ACOs.


FLASH: Medical device tax payments hit the $1B mark

FLASH: Medical device tax payments hit the $1B mark-massdevice: The 2.3% medical device sales tax has cost the industry an estimated $1 billion so far, according to a report released by a coalition of medical device lobbying groups, which called the milestone "frightening." The tax costs medical device makers an average of $194 million per month, funds which should be going to research & development efforts and to salaries for new employees, according to the Medical Imaging & Technology Alliance, AdvaMed and the Medical Device Manufacturers Assn. 

Monday, July 15, 2013

Draft Guidance Tackles Common Errors In Adverse Event Reporting

Draft Guidance Tackles Common Errors In Adverse Event Reporting-thegraysheet: FDA issued a revised guidance (PDF) on its medical device reporting requirements for manufacturers, including a new “frequently asked questions” section and a list of common errors made by device companies in their adverse event reports to FDA. The draft guidance, which will replace FDA’s 1988 and 1997 MDR guidances once finalized, explains FDA’s regulations for manufacturer adverse event reporting and recordkeeping and clarifies the agency’s interpretations of the requirements.

CMS Proposes Centralized Review, New Standards For Reimbursement Of IDE Studies

CMS Proposes Centralized Review, New Standards For Reimbursement Of IDE Studies-graysheet: CMS has proposed some significant changes to the process for gaining Medicare coverage of device trials. Responding to device industry complaints about the unwieldy process of obtaining jurisdiction-by-jurisdiction Medicare coverage for clinical study costs, the agency is proposing to make these coverage decisions centrally.

McConnell: Administration playing games with Obamacare

McConnell: Administration playing games with Obamacare-politico: Senate Majority Leader Mitch McConnell charged on Sunday that President Barack Obama is "selectively delaying" parts of the federal health care law "as if it's all just kind of a smorgasbord of options for him to figure out which ones to execute and which part of the law not to execute."

Reid lauds Obamacare as 'wonderful'

Reid lauds Obamacare as 'wonderful'-politico:  Senate Majority Leader Harry Reid said Sunday that Obamacare has been "wonderful for America" and that Republicans should stop the series of symbolic votes to repeal the healthcare reform law.