FDA Claims Short-Term Success For Its Pre-Market Device Reforms

FDA Claims Short-Term Success For Its Pre-Market Device Reforms-healthnewsdaily: With many of CDRH’s 2011-announced 510(k) and science reforms at least partially implemented, the device center says it is seeing tangible, positive results, citing a turnaround on multiple measures of review performance following a peak in negative efficiency trends in fiscal year 2010

Durbin Lays Out Potential Entitlement Reforms For Longer-Term Fiscal Cliff Solution

Durbin Lays Out Potential Entitlement Reforms For Longer-Term Fiscal Cliff Solution-insidehealthpolicy: Sen. Dick Durbin (D-IL) Tuesday laid out a list of Medicare and Medicaid reforms that could be considered as part of longer-term entitlement reforms expected to take place once the fiscal cliff is averted, but made clear that the public health programs should not be a part of the short-term solution. The Democratic Majority Whip touted several options -- such as extending Medicaid drug rebates to Medicare's Part D program and altering Medicaid provider taxes - that would face an uphill battle due from influential stakeholders, and also pointed to increasing Medicare means-testing, encouraging greater use of generic drugs, expanding competitive bidding, and building upon payment reforms in the Affordable Care Act as promising concepts. He stressed that he would only consider an increase in the Medicare eligibility age if there is an “assurance and guarantee” that all people would have access to affordable coverage during any gaps

Obama public relations effort aims to avoid ‘fiscal cliff’

Obama public relations effort aims to avoid ‘fiscal cliff’-washingtonpost: The White House signaled Tuesday that it will try to marshal the momentum from President Obama’s reelection triumph into another victory at the negotiating table, launching a full-fledged public relations effort to avoid a “fiscal cliff” that could jolt the nation back toward recession.

Taxing the rich remains popular

Taxing the rich remains popular-washingtonpost: Raising taxes on income over $250,000 remains a broadly popular approach to dealing with the country’s budgetary woes, according to a new Washington Post-ABC News poll.Sixty percent of all Americans back higher taxes on higher incomes in the new Post-ABC data. Earlier this month, an identical 60 percent of voters in the presidential election said income taxes should be raised on income over $250,000, according to the national exit poll.

Hospitals Face Pressure to Avert Readmissions

Hospitals Face Pressure to Avert Readmissions-nytimes.com: After years of gently prodding hospitals to make sure discharged patients do not need to return, the federal government is now using its financial muscle to discourage readmission's.

CMS Misses Obama's Goal To Cut Improper Medicare Payments In Half

CMS Misses Obama's Goal To Cut Improper Medicare Payments In Half-insidehealthpolicy.com: CMS failed to reach a goal set by President Barack Obama of cutting Medicare improper payments in half by 2012, according to the agency's financial report released Wednesday (Nov. 21), as the program's improper payment rate stayed relatively stable between 2011 and 2012.

Stakeholders Digest ACA Regs As Fiscal Talks Ramp Up Post-Thanksgiving

Stakeholders Digest ACA Regs As Fiscal Talks Ramp Up Post-Thanksgiving-insidehealthpolicy.com: Activity on and off Capitol Hill is back in full swing with Congress returning this week to continue its high-stakes effort to avert the fast-approaching budget sequester and health care stakeholders bracing for the possibility of additional funding cuts. Stakeholders are also diving into the details of major health care rules the Obama administration unveiled just before Thanksgiving as it plows forward to get ACA pieces in place by 2014. The new rules outline HHS’ proposed policy direction on key issues such as essential health benefits, actuarial value, wellness programs and insurance market reforms that include age rating compression and guaranteed issue.

CDRH Discloses Guidance Priorities For Fiscal 2013

CDRH Discloses Guidance Priorities For Fiscal 2013-Thegraysheet: The device center has posted its “A-list” and “B-list” of final and draft guidance documents it plans to release this fiscal year; the long-awaited regulatory framework for laboratory-developed tests didn’t make the lists.

Lack Of Final Rule Won't Delay Device Tax Effects, Industry Officials Warn

Lack Of Final Rule Won't Delay Device Tax Effects, Industry Officials Warn-insidehealthpolicy: While still optimistic that Congress will repeal the ACA's device tax, key industry officials say that device companies still need to “budget” for the device tax's possible Jan. 1 implementation and the economic effects of the tax are already being felt across the industry, even though the IRS has yet to issue a final rule on the ACA provision. The Advanced Medical Technology Association and other industry groups continue to lobby lawmakers to repeal the tax during the lame duck session and AdvaMed officials said last week they were "heartened" by growing support and optimistic the repeal would be included in an end-of-the-year legislative package.

‘Fiscal cliff’: Consensus on increasing tax revenue, a wide gulf on how to do it

‘Fiscal cliff’: Consensus on increasing tax revenue, a wide gulf on how to do it-washingtonpost.com: For the first time in decades, a bipartisan consensus has emerged in Washington to raise taxes. But negotiators working to avert the year-end “fiscal cliff” remain far apart on crucial details, including how taxes should go up and who should pay more.

Device History Record Oversights A Clear Path To Quality Troubles

Device History Record Oversights A Clear Path To Quality Troubles-thegraysheet: Device history records that do not include labeling, signatures on documents and dates of product manufacture are just a few of the problems that may cause FDA to dig deeper during facility inspections.

Transcatheter Valve Procedures Expected, Spurring Growth In Hybrid Operating Rooms

Transcatheter Valve Procedures Expected, Spurring Growth In Hybrid Operating Rooms-thegraysheet: Infrastructure requirements for hospitals looking to expand their offerings to TAVR include a boatload of medical equipment. ECRI Institute discussed hospital considerations for offering transcatheter aortic valve implantation services in a recent webinar.

Many Americans unaware of health-care law changes

Many Americans unaware of health-care law changes-washingtonpost.com: After surviving a Supreme Court decision and a presidential election, the Obama administration’s health-care law faces another challenge: a public largely unaware of major changes that will roll out in the coming months.

Tax loopholes alone can't solve fiscal cliff

Tax loopholes alone can't solve fiscal cliff-politico.com:Raise revenues and reform the Tax Code? Easy — just eliminate all the tax loopholes, right? Good luck with that. “Eliminating loopholes” sounds a lot better than “raising rates”: The tax rate is what I pay, and a loophole is what the other guy gets.

Many Surgical Complications Show Up After Patients Get Home

Many Surgical Complications Show Up After Patients Get Home-npr.com: It's natural for patients returning home from the hospital after surgery to feel a sense of relief that the worst is over. But, research published this week suggests those patients and their doctors shouldn't let their guard down too soon.

President Obama won, but Obamacare didn't

President Obama won, but Obamacare didn't-politico.com: During the campaign, President Barack Obama minimized discussion of his first term’s most consequential new law: the Patient Protection and Affordable Care Act, or what’s commonly referred to as Obamacare. That was no accident. Undoubtedly, the campaign knew that Obamacare is, as it always has been, deeply unpopular with the American people. In fact, Obamacare epitomizes the public’s greatest concerns about this administration: the massive expansion of government and failure to deliver a new era of post-partisanship to Washington, since the law was jammed through using a party line vote and every available legislative trick. Bringing up health care risked stirring the passions that fueled the tea party’s rise and the Democrats’ defeat in 2010

Medical device tax: Are "lame duck" lobbying efforts in vain?

Medical device tax: Are "lame duck" lobbying efforts in vain?-medicaldevice.com: Medical device industry players have focused their latest repeal efforts on pushing Congress during the "lame duck" session after the election, but some are skeptical that the tax will be addressed before it hits next year.Medical device industry stakeholders have spent much time and money lobbying to repeal the 2.3% medical device tax before it takes effect in January, but voices from Capitol Hill are starting to temper that enthusiasm.

Medicare cuts give health providers jitters

Medicare cuts give health providers jitters-politico.com: The $716 billion in Medicare “cuts” that got so much attention in the presidential election have already begun sinking their teeth into health care providers.And there are widespread jitters that any further cuts as part of a year-end deal to stave off sequestration or strike a “grand bargain” for a long-term fiscal deal would deeply gouge some providers, if not put them out of business.

FDA Taps First 'Breakthrough' Product As Stakeholders Propose Criteria

FDA Taps First 'Breakthrough' Product As Stakeholders Propose Criteria-insidehealthpolicy.com: FDA recently made its first breakthrough drug designation but is still grappling with how sponsors will utilize the expedited development pathway that was created as part of the recently enacted FDA Safety and Innovation Act, agency officials revealed this week. The revelation came as stakeholders this week proposed qualitative criteria the agency could use to evaluate eligibility for the new designation and categories of drugs that could qualify for the expedited development pathway.

At Bipartisan Budget Meeting, Familiar Hurdles but a New Attitude

At Bipartisan Budget Meeting, Familiar Hurdles but a New Attitude-NYTimes.com: President Obama and Congressional leaders on Friday reopened budget negotiations that ended badly in 2011 with surprising bipartisan bonhomie, and even some initial agreements toward a year-end deal. Yet a familiar hurdle remains before any handshakes: resolving the parties’ dispute over whether to extend the Bush-era tax rates for the wealthy.

Medicare Panel Laments Holes In Ventricular Assist Device Evidence Base

Medicare Panel Laments Holes in Ventricular Assist Device Evidence Base-Health News Daily: CMS does not currently have a national coverage determination process open on ventricular assist devices for heart failure, though the agency may open a new one, an agency official said.

Device Industry Amps Up Efforts To Repeal Device Tax In Lame Duck Session

Device Industry Amps Up Efforts to Repeal Device Tax in Lame Duck Session-The Gray Sheet: Industry groups flew in more than 50 CEOs to visit Capitol Hill, launched an ad campaign and released an impact report last week as part of a stepped-up effort to get Congress to repeal the impending medical device tax before it goes into effect Jan. 1

Loopholes and revenues: Five questions

Loopholes and revenues: Five questions-politico.com:Washington's word of the moment: loopholes. They're the nefarious sounding — but perfectly legal — perks in the tax code that House Speaker John Boehner says could dig up new revenue for the government without raising taxes. President Barack Obama has called that math bogus. 

Medtronic Loses Appeal in $74 Million Edwards Patent Case

Medtronic Loses Appeal in $74 Million Edwards Patent Case-Bloomberg.com: Medtronic Inc. (MDT) lost its bid to overturn a $74 million jury verdict won by Edwards Lifesciences Corp. (ED) and may face a court order halting production of some of its CoreValve heart valves

McConnell warns Obama on taxes

McConnell warns Obama on Taxes-politico.com: Senate Minority Leader Mitch McConnell issued a stark warning to Senate Democrats and President Barack Obama who see their election victories as a clear mandate to raise taxes on the rich: He won't let it happen

Will incoming Mass. Senator Warren keep true to pledge to repeal medical device tax?

Will incoming Mass. Senator Warren keep true to pledge to repeal medical device tax?-massdevice.com:

Medical device industry stakeholders hope Senator-elect Elizabeth Warren will hold true to campaign pledges to push for repeal of the medical device tax.

Obamacare survives-now what?

Obamacare survives-now what?- politico.com:

“Obamacare” lives.

It has now survived two near-death experiences. The Supreme Court could have struck the law down, but it didn’t. And with Barack Obama in the White House for another four years, it’s not going to get repealed — or even gutted.

Up Next: The Fiscal Cliff

Up Next: The Fiscal Cliff-politico.com: The split decision voters rendered Tuesday night is the worst-case scenario for a quick resolution to the fiscal morass awaiting Congress in the lame-duck session.

Obama and Romney Deadlocked, Polls Show

Obama and Romney Deadlocked, Polls Show-wsj.com:
President Barack Obama and Mitt Romney crisscrossed the country Sunday to energize supporters in key states, as new polls forecast a down-to-the-wire election and both sides claimed they had the momentum to win.

Swing-State Map

Swing-State Map-politico.com