Behind the scenes of a GOP meltdown

Behind the scenes of a GOP meltdown-politico: Things were so bad for Speaker John Boehner Thursday night, support for his Plan B tax bill so diminished, the limits of his power with his own party laid bare, that he stood in front of the House Republican Conference and recited the Serenity Prayer.

Cliff chaos: Boehner pulls GOP bill

Cliff chaos: Boehner pulls GOP bill-politico: The House Republican Conference turned its back on Speaker John Boehner Thursday, forcing GOP leadership to abandon its plan to extend Bush-era tax breaks for income under $1 million.

Australia, Brazil, Canada and U.S. plan shared medical device audit program

Australia, Brazil, Canada and U.S. plan shared medical device audit program-massdevice.com: The medical device regulators of Australia, Brazil, Canada and the US have all signed on to a statement of cooperation to develop a single audit program for medical devices to be used by all four market authorities.

House GOP spending cuts target Obamacare, Medicaid

House GOP spending cuts target Obamacare, Medicaid-politico: The House is about to recycle Paul Ryan’s sequester replacement bill — most of it, anyway — and put it up for a vote so Republicans can vote for spending cuts along with the “Plan B” tax bill that they’ll be asked to pass Thursday.

FDA Gets Set For Independent Assessment Of Device Review Process With Work Plan

FDA Gets Set For Independent Assessment Of Device Review Process With Work Plan-thegraysheet: It was the device industry in the MDUFA III negotiations that called for an independent assessment of CDRH’s pre-market review program by “a private, independent consulting firm” as a way to improve the device review process.

Medical device tax: No time for second-guessing

Medical device tax: No time for second-guessing-massdevice: Medtech industry lobbyists are focused on repealing the 2.3% medical device tax before it takes effect in 2 weeks, encouraging medtech executives, employees and other stakeholders to reach out to local lawmakers.

Latest Obama Fiscal Cliff Offer: $400B In Health Savings, 1-Year Doc Fix, Turned-Off Sequester

Latest Obama Fiscal Cliff Offer: $400B In Health Savings, 1-Year Doc Fix, Turned-Off Sequester-insidehealthpolicy: President Obama is proposing to turn off the budget sequester's automatic cuts for at least some sectors, enact a one-year “doc fix” this year and then cut $400 billion from health care as a part of entitlement reforms next year, according to his latest fiscal cliff offer made to House Speaker John Boehner (R-OH). It is unclear if the sequester turn-off would apply only to defense, or also include the slated 2 percent cut to Medicare providers.

Device Tax Implementation Costs Could Reach $667 Mil. – AdvaMed Survey

Device Tax Implementation Costs Could Reach $667 Mil. – AdvaMed Survey-thegraysheet: Recent surveys by AdvaMed and MITA seek to quantify the impact of the device tax on industry and jobs as part of their ongoing repeal effort.

Poll: 69% disapprove of GOP on fiscal cliff

Poll: 69% disapprove of GOP on fiscal cliff-politico: Nearly seven-in-ten Americans disapprove of how congressional Republicans are handling the fiscal cliff, according to a poll released Tuesday, with a bare majority expecting a deal to be reached by the end of 2012.

CDRH Extends Device Establishment Registration Deadline

CDRH Extends Device Establishment Registration Deadline-thegraysheet: The device center has extended the annual medical device registration period by one month to Jan. 31, as companies and FDA adopt new registration and registration fee requirements established in the FDA Safety and Innovation Act and recent regulatory revisions.

GAO: Innovation Center not avoiding overlap

GAO: Innovation Center not avoiding overlap-politico: The top auditor for Congress says the new Innovation Center needs to work harder at making sure it’s not duplicating efforts with the rest of CMS.

PCORI launches $50,000 CER innovation challenge

PCORI launches $50,000 CER innovation challenge-insidehealthpolicy: The Patient-Centered Outcomes Research Institute launched of the PCORI Challenge, a competition to create a system that will connect healthcare researchers and patient partners in an effort to advance patient-centered comparative effectiveness research. PCORI partnered with Health 2.0, a San Francisco-based health technology company, to create the competition, which will award a total of $50,000 to winning developers, PCORI announced Friday (Dec. 14).

Haley to announce DeMint successor

Haley to announce DeMint successor-politico: COLUMBIA, S.C. — South Carolina Gov. Nikki Haley is announcing a replacement for U.S. Sen. Jim DeMint. Haley spokesman Rob Godfrey says Haley will make the announcement at noon Monday at the Statehouse

Device Tax Delay? 18 Senate Dems Say ‘Yes’; Obama Says ‘No’

Device Tax Delay? 18 Senate Dems Say ‘Yes’; Obama Says ‘No’-graysheet: -Potential delay of the device tax seemed to gain momentum with a recent letter from 18 Senate Democrats to Senate Majority Leader Reid, but the president and Senate Finance Committee leadership are not on board.

As "fiscal cliff" looms, health reform questions linger

As "fiscal cliff" looms, health reform questions linger-cbsnews: Washington lawmakers this month are squarely focused on deficit reduction as they attempt to scramble off the so-called "fiscal cliff." All the while, however, the government is proceeding with the costly and ambitious rollout of the Affordable Care Act.

Democrats split on Medicare concessions in cliff talks

Democrats split on Medicare concessions in cliff talks-politico: A growing number of Democrats in the Senate are ready to offer up a key concession on Medicare to try to reach a deal on the fiscal cliff: higher premium payments for wealthy seniors.

But that might not get them very far.

President Obama defends the medical device tax (video)

President Obama defends the medical device tax (video)-massdevice: President Barack Obama tells reporters that he's unwilling to consider delaying the medical device tax because healthcare reform is "going to be great for business."

Words of caution for device tax repeal efforts

Words of caution for device tax repeal efforts-massdevice: As more voices join the urgent call for repeal of the medical device tax, some caution against depriving the Affordable Care Act of the nearly $30 billion in funding the tax is expected to raise over 10 years.

As State Budgets Rebound, Federal Cuts Could Pose Danger

 As State Budgets Rebound, Federal Cuts Could Pose Danger-nytimes: After years of budget cuts and sluggish recovery, states expect to see their revenues climb back to prerecession levels this year for the first time since the financial crisis hit. But even as some states hope to restore some of the deep spending cuts they have made, they face a new threat.

Cohen Says CMS Won't Delay Comment Deadlines For Proposed ACA Regulations

Cohen Says CMS Won't Delay Comment Deadlines For Proposed ACA Regulations-insidehealthpolicy: CMS Center for Consumer Information and Insurance Oversight Director Gary Cohen said Thursday (Dec. 13) that HHS will not extend the deadline for comments on several key health reform law regulations that have 30-day comment periods, a timeframe protested by GOP lawmakers as well as the U.S. Chamber of Commerce for being too short. A Chamber official told Inside Health Policy that the group could present an argument to the Office of Management and Budget that the 30-day timeframe doesn’t comply with the president’s own executive order that says comment periods on proposed regulations generally should be at least 60 days

Tax relief could come in form of credit

Tax relief could come in form of credit-politco: Over the past few weeks, reports have surfaced that President Barack Obama is interested in providing middle-class families with additional tax cuts beyond just the preservation of the Bush-era tax rates. While that is welcome news, not all methods of delivering middle-class tax relief are created equal.

Jim DeMint: Obama wants cliff dive

Jim DeMint: Obama wants cliff dive-politico:South Carolina GOP Sen. Jim DeMint accused President Barack Obama on Thursday of trying to take the country over the fiscal cliff. “The president campaigned on raising taxes and getting rid of the Bush-era tax cuts, and he’s gonna get his wish,” DeMint said on CBS’s “This Morning.”

Price: Dems will turn against Obamacare

Price: Dems will turn against Obamacare-politico: Republican Rep. Tom Price predicted Thursday that Democrats will slowly begin turning against the less popular elements of the Affordable Care Act, making them more vulnerable to repeal efforts.

Corporate Taxes on Table in Cliff Talks

Corporate Taxes on Table in Cliff Talks-wallstreetjournal: The White House has told Republicans it would include an overhaul of the corporate-tax code as part of any deal to reduce the deficit, people familiar with the talks said, a move to court business groups as budget negotiations intensify.

Nancy Pelosi: Cliff deal before Christmas

Nancy Pelosi: Cliff deal before Christmas-politico: House Minority Leader Nancy Pelosi said Wednesday that she was “more optimistic” than some of her colleagues about reaching a deal to avoid the fiscal cliff.

Poll: Boehner bungling 'cliff' talks

Poll: Boehner bungling 'cliff' talks-politico: House Speaker John Boehner is getting poor reviews on his handling of the fiscal cliff negotiations, according to a poll released Wednesday, with even Republicans failing to give him majority support.

Fight continues over fiscal cliff floor

Fight continues over fiscal cliff floor-politico: President Barack Obama and House Speaker John Boehner are fighting over the fiscal cliff endgame, but that doesn’t mean they’ve agreed on where to start.

Herger introduces Medicare premium support bill

Herger introduces Medicare premium support bill-politico: The chairman of the House Ways and Means health subcommittee on Tuesday introduced an ambitious health care bill that encompasses some of Republicans’ most favored health reforms. But Rep. Wally Herger (R-Calif.) is retiring at the end of this term and unlikely to see any of the initiatives become law before then.

Klobuchar wants device tax delay in deal

Klobuchar wants device tax delay in deal-politico: Sen. Amy Klobuchar (D-Minn.) says the medical device tax "cries out for change" because it will hurt jobs in the device industry, and she wants to see it delayed as part of a bigger year-end deal in Congress.

W.H. makes R&D push during cliff debate

W.H. makes R&D push during cliff debate-politico:The Obama administration is maneuvering behind the scenes to shield billions of dollars in federal research aid from big budget cuts and the looming, dreaded fiscal cliff.

Crafting a boom economy

Crafting a boom economy-politico: Most politicians in the most powerful positions in Washington agree in private that there are a half-dozen or so big things they could and should do that could put a rocket booster on the U.S. economy — but they are too timid to say it in public.

'Dr. No' of Senate says 'yes' to taxes

'Dr. No' of Senate says 'yes' to taxes-politico: The Oklahoma senator and obstetrician known as “Dr. No” has taken on the most unlikely of roles: getting Republicans to say “yes” to tax hikes.Tom Coburn, who has blocked dozens of bills, infuriated Democratic leaders and been on the lopsided end of some 96-3 votes, has been encouraging fellow Republicans both publicly and behind the scenes to break with the anti-tax orthodoxy that has come to define — some say hamstring — the modern GOP.

Senate Democrats, Including Durbin, Press For Device Tax Delay Amid Fiscal Talks

Senate Democrats, Including Durbin, Press For Device Tax Delay Amid Fiscal Talks-insidehealthpolcy: Senate Majority Whip Dick Durbin (IL), along with 15 other members of the Democratic caucus and two key incoming senators, is urging Majority Leader Sen. Harry Reid (NV) to consider delaying implementation of the health reform law's medical device tax as lawmakers continue fiscal negotiations. One key lobbyist said a device tax delay could become part of a short-term fiscal agreement as it has gained attention among Democratic senators.

Time running out on ‘fiscal cliff’ deal

Time running out on ‘fiscal cliff’ deal-washingtonpost: The contours of a deal to avert the year-end fiscal cliff are becoming increasingly clear. But progress has been slow, and time is running out for leaders to seal an agreement and sell it to restless lawmakers who so far have been given little information.

DeMint departure kicks off Senate resignation guessing game

DeMint departure kicks off Senate resignation guessing game-washingtonpost: The resignation last week of Sen. Jim DeMint (R-S.C.) not only shocked the political world but, just one month removed from the 2012 election, formally kicked off chatter about the 2014 landscape.

Medical Device Innovation Consortium Launches, Aims To Start Projects In 2013

Medical Device Innovation Consortium Launches, Aims To Start Projects In 2013-thegraysheet: The first public-private partnership to focus on promoting medical device regulatory science, known as the Medical Device Innovation Consortium, aims to speed up patient access to medical device technologies.

CDRH Sets 2013 Strategic Priorities

CDRH Sets 2013 Strategic Priorities-thegraysheet: Topics include anticipated guidance efforts, as well as emphasis on the work of the center’s nascent entrepreneurs-in-residence program. Among CDRH’s 2013 strategic priorities are plans to launch a pilot for companies to submit electronic 510(k)s, to issue a report identifying opportunities for fostering a “connected health care environment,” and to start implementing a plan for incorporating social media into the center’s communication with industry and others.

Jim DeMint to resign to head Heritage Foundation

BREAKING: Jim DeMint to resign to head Heritage Foundation-politico: Sen. Jim DeMint abruptly announced plans to resign his South Carolina Senate seat to run the conservative Heritage Foundation, a stunning move that could have repercussions in the chamber and in Senate GOP primaries across the country.

Medical device tax set but industry still fighting

Medical device tax set but industry still fighting-politico: The IRS has finalized details on the new medical device tax — as the medical device industry has redoubled its efforts to get it repealed. The 2.3 percent excise tax on many medical devices, which is part of the 2010 health care law, takes effect Jan. 1. On Wednesday, an Internal Revenue Service final rule detailed plans to levy the tax. It was originally projected to raise up to $20 billion in revenues over 10 years, but the Joint Committee on Taxation later estimated it would be around $29 billion.

Geithner: 'Absolutely' willing to go off the fiscal cliff

Geithner: 'Absolutely' willing to go off thefiscal cliff-politico:Treasury Secretary Tim Geithner said Wednesday that the Obama administration was prepared to dive off the fiscal cliff if Republicans do not agree to raise tax rates on upper income brackets

Obama Appeals to Business for Support on Tax Plan

Obama Appeals to Business for Support on TaxPlan-nytimes: WASHINGTON — After a campaign that drove a deep wedge between them, President Obama is now trying to rebuild relations with the business community in hopes of enlisting it in his showdown with Republicans in Congress over the looming fiscal crisis.

Some in GOP urge lawmakers to back tax hikes for changes in safety-net programs

Some in GOP urge lawmakers to back tax hikes for changes in safety-net programs-washingtonpost: A growing chorus of Republicans is urging House leaders to abandon their staunch opposition to higher tax rates for the wealthy with the aim of clearing the way for a broad deal that would also rein in the cost of federal health and retirement programs.

Van Hollen: Congress Should Pay Down Deficit By Speeding ACA Reforms

Van Hollen: Congress Should Pay Down DeficitBy Speeding ACA Reforms-insidehealthpolicy: Rep. Chris Van Hollen (D-MD) said Wednesday (Dec. 5) that he wants to help pay down the deficit by speeding Medicare delivery and payment reforms, including establishment of accountable care organizations, bundled pay and integrated care for dual eligibles. Also, Sen. Bob Corker (R-TN) signaled that he could go along with letting tax rates for the wealthy expire -- he has said he does not feel bound to Grover Norquist’s no-tax pledge -- but added that such a policy must be accompanied with the type of entitlement reform that Van Hollen and Democrats dislike. Corker wants to see those major entitlement reforms agreed to before the end of the year, and he said he would not vote for a bill that assigns top-line cuts to Medicare without filling in the policy details of how those savings would be achieved.

Final IRS Device Tax Rule Changes Little From Draft As Industry Focuses On Repeal Effort

Final IRS Device Tax Rule Changes Little FromDraft As Industry Focuses On Repeal Effort-thegraysheet: Though the IRS final regulation offers some wins for industry, manufacturers continue to seek repeal of the device tax. The Internal Revenue Service’s final regulation to implement the 2.3% excise tax on U.S. device sales was issued yesterday, providing needed guidance to manufacturers, but industry remains squarely focused on getting rid of the tax, which they see as a job and innovation killer

Edwards Lifesciences gains on affirmed earnings guidance, 2013 forecast | Wall Street Beat

Edwards Lifesciences gains on affirmed earnings guidance, 2013 forecast | Wall Street Beat-massdevice: Shares of medical device company Edwards Lifesciences are up today after the heart valve maker affirms its earnings guidance for the rest of the year and issues its outlook for 2013

House GOP Eyes 'Range Of Options' To Cut $600B In Health Care But Mum On Details

House GOP Eyes 'Range Of Options' To Cut $600B In Health Care But Mum On Details-insidehealthpolicy: House Republicans propose to cut $600 billion from health care as a part of a Dec. 3 “fiscal cliff” counteroffer to the president that is based on former fiscal commission co-chair Erskine Bowles' testimony last year to the “super committee,” during which the former Clinton White House chief of staff urged lawmakers to consider raising the Medicare eligibility age but otherwise offered no specifics. Boehner spokesperson Michael Steel told Inside Health Policy “there are a range of options” on how to get to the $600 billion in health care savings, including changes to the Affordable Care Act, though he would not elaborate on detail

Democratic Group to Offer Tax Plan With Huge Payoff

Democratic Group to Offer Tax Plan With Huge Payoff-newyorktimes: WASHINGTON — Democratic luminaries with ties to the Obama and Clinton administrations, including two former Treasury secretaries and two former White House chiefs of staff, on Tuesday will enter the tax debate with an overhaul plan that would raise an additional $1.8 trillion in the first decade.

Medical Device Innovation Consortium Launches, Aims To Start Projects In 2013

Medical Device Innovation ConsortiumLaunches, Aims To Start Projects In 2013-thegraysheet: The first public-private partnership to focus on promoting medical device regulatory science, known as the Medical Device Innovation Consortium, aims to speed up patient access to medical device technologies.

‘Fiscal cliff’ talks at a stalemate over tax hikes

‘Fiscal cliff’ talks at a stalemate over tax hikes-washingtonpost.com: As the White House and Republican leaders enter the final month of negotiations to avoid a year-end “fiscal cliff,” both sides struck an uncompromising tone Sunday, as warnings mounted that they will be unable to forge an agreement to stop an automatic series of deep spending cuts and large tax hikes that could push the economy into recession.

CMS Issues List Of Potential National Coverage Determination Topics

CMS Issues List Of Potential National Coverage Determination Topics-thegraysheet: Most of the 33 items or services in the list have implications for manufacturers of medical devices, combination products or diagnostics.

CMS Redefines Coverage-With-Evidence-Development In Draft Guidance

CMS Redefines Coverage-With-Evidence-Development In DraftGuidance-thegraysheet: The document replaces a 2006 guidance, making substantial changes in response to public comment and six years of experience with the policy.