Exclusive: The Woodward, Sperling emails revealed

Exclusive: The Woodward, Sperling emails revealed-politico: POLITICO’s “Behind the Curtain” column last night quoted Bob Woodward as saying that a senior White House official has told him in an email he would “regret” questioning White House statements on the origins of sequestration. The official in question is Gene Sperling, economic adviser to the president. The White House has since pushed back, saying the exchange was far more innocuous than Woodward claims.

Device lobby "doubles down" on medical device tax repeal

Device lobby "doubles down" on medical device tax repeal-massdevice: MASSDEVICE ON CALL — Medical device lobbying group AdvaMed unveiled its 2013 agenda, highlighting its efforts to "double down" on efforts to repeal the 2.3% medical device tax that took effect at the start of the year. "This issue is critically important to companies large and small that already are living with the real-world harmful impact this tax is having – including layoffs, cuts in R&D and delayed expansion plans," AdvaMed president & CEO Stephen Ubl said in prepared remarks.

The security risks of medical devices

The security risks of medical devices-massdevice: Beth Israel Deaconess has been outspoken about the risks of malware on FDA 510k approved medical devices such as radiology workstations, echocardiogram machines, and patient monitors. Although these devices appear to be "appliances" that you simply plug into the network and use for patient care, they are actually sophisticated computers, often running outdated versions of operating systems and applications that are not resilient against purposeful attacks.

Obamacare is ramping up a health-care turf war

Obamacare is ramping up a health-care turf war-washingtonpost: The Affordable Care Act will extend health insurance to millions of Americans — a number that grows weekly with Republican governors signing onto the Medicaid expansion. Health policy experts expect that increased insurance coverage will lead to increased demand for health care. Once a patient has access to health insurance coverage, the thinking goes, she or he will be more likely to turn up seeking care.

Sources: Obama to meet with congressional leaders

Sources: Obama to meet with congressional leaders-politico: President Obama is scheduled to meet with congressional leaders from both parties at the White House on Friday, according to three sources briefed on the plans.House Speaker John Boehner, Minority Leader Nancy Pelosi, Senate Majority Leader Harry Reid and Minority Leader Mitch McConnell are expected to attend the meeting to discuss the sequester cuts.

Medicare Needs Fixing, but Not Right Now

Medicare Needs Fixing, but Not Right Now-newyorktimes: What’s the rush? For all the white-knuckled wrangling over spending cuts set to start on Friday, the fundamental partisan argument over how to fix the government’s finances is not about the immediate future. It is about the much longer term: how will the nation pay for the care of older Americans as the vast baby boom generation retires? Will the government keep Medicare spending in check by asking older Americans to shoulder more costs? Should we raise taxes instead?

Insiders Foresee One-Month Sequester, Effort To Give Agencies Flexibility On Cuts

Insiders Foresee One-Month Sequester, Effort To Give Agencies Flexibility On Cuts-insidehealthpolicy: Washington insiders, including FDA funding advocates, are bracing for across-the-board funding cuts to go into effect March 1 for at least one month while lawmakers work toward a government funding measure to replace the continuing resolution that expires at the end of March and also address the sequester. The Alliance for a Stronger FDA also told its members Monday (Feb. 25) there is increased discussion on Capitol Hill about legislation that would give agencies more discretion in allocating the cuts as opposed to requiring they be imposed equally.

Sequester Watch: Washington Hold 'Em

Sequester Watch: Washington Hold 'Em-politico: STATE OF PLAY: STATUS QUO, WITH A TWIST -- We still expect sequestration will begin to take effect on Friday and any real push to alter its effects to come after that. But talks about how to give the administration greater flexibility to apply the cuts are beginning to ramp up on both sides of the Capitol. We told you last week that discussions were ongoing on the House side about how to let the Pentagon prioritize better, and Senate Republicans are set to have a spirited debate about just that topic this week. We'll know more today as party caucuses in both chambers meet for the first time in more than a week. One reason that there's no rush to beat the deadline: The Draconian cuts the White House warns of won't all be felt immediately. Unlike a government shutdown, where furloughs are a matter of agencies not having the authority to spend money and they happen immediately, the sequestration cuts give agencies plenty of room to pick who works when. Some folks will end up taking a few unpaid Fridays off while others might have a week off next month. Easy to say if you're not facing down a furlough, but worth remembering as you analyze sequestration.

Sequestration: Bring it on!

Sequestration: Bring it on!-politico: Politicians have lost their power to frighten me. I no longer believe the sky is falling. I have lived through America’s past disasters: Vietnam. Watergate. Disco. We survived them all. We have grown strong at the broken places. But now the pols have come up with a new word to panic us: sequester.

Device makers, regulators butt heads over new E.U. regulations

Device makers, regulators butt heads over new E.U. regulations-massdevice: MASSDEVICE ON CALL — Medical device makers and European regulators appear to be at an impasse over new regulations proposed in the wake of the breast implant recall that revealed shortcoming in the E.U. The European Parliament is poised to host a public debate today to hash out the details of a new medtech regulatory system that incorporates some elements that are reminiscent of the device oversight in the U.

GOP govs to Hill: Get back to bargaining

GOP govs to Hill: Get back to bargaining-politico: Ask Pennsylvania Gov. Tom Corbett and Utah Gov. Gary Herbert what they think of Hill Republicans’ strategy on the sequester, and you get the exact same response: “What strategy?” It’s a sign that Republican governors might be still giving President Barack Obama a lot of the blame for the sequester — but they're fed up with their own side, too.

Dim sequestration outlook: Cuts before compromise

Dim sequestration outlook: Cuts before compromise-politico: Congress returns Monday with all eyes on a last Senate attempt to forestall across-the-board spending cuts March 1 that threaten to cripple government services this spring and roll back the clock to before Barack Obama’s presidency. Discretionary spending is slated to fall below 2008 levels for the first time in Obama’s tenure, even allowing for the recent Hurricane Sandy emergency aid bill. When adjusted for inflation, POLITICO’s calculations show that Obama will have billions less than former President George W. Bush in nondefense appropriations — so important to his second-term agenda.

CMS Staffs Up, Posts Resources For Upcoming Sunshine Requirements

CMS Staffs Up, Posts Resources For Upcoming Sunshine Requirements-thegraysheet: The agency is taking steps to help companies prepare for the new physician payment disclosure mandates, which officials are now referring to as the “Open Payment Program,” while also getting ready to enforce the rules.

Orrin Hatch: 'I'm For Sequestration' Though It Would Be 'Devastating To Our Nation's Readiness'

Orrin Hatch: 'I'm For Sequestration' Though It Would Be 'Devastating To Our Nation's Readiness'-huffingtonpost: Hatch is hardly alone in trying to straddle these two positions. House Republican leadership has made the case that sequestration is a terrible way to go about deficit reduction though one that they will welcome if need be. The National Review editorial board, on Thursday, said it was "unwise policy" though they weren't "sure any of the extant alternatives are any better."

Closely-Held Draft Reveals CMS To Review Plans For Discriminatory Language

Closely-Held Draft Reveals CMS To Review Plans For Discriminatory Language-insidehealthpolicy:  CMS' insurance office in pre-published draft guidance sent to select stakeholders reveals that the agency plans to perform an “outlier analysis” of qualified health plans' (QHP) cost-sharing as part of the certification process and will ask plans to modify the structure of their benefits if needed. The closely-held draft, obtained by Inside Health Policy, states that such analyses should help prevent adverse selection

Medical device tax more likely raise prices than lower headcounts, survey says

Medical device tax more likely raise prices than lower headcounts, survey says-massdevice: 

More than 40% of medical device makers surveyed said they would raise prices to deal with some or all of the impact of the new 2.3% sales tax, compared with only 11% who said they would reduce their staff.

Medtech moods improving in 2013, survey says

Medtech moods improving in 2013, survey says-massdevice: Things are looking rosy in 2013 for the majority of respondents in a medical device industry survey, which aimed to capture attitudes about the year ahead.Of the more than 3,000 survey participants, most said they were either "somewhat" or "very positive" about the general business environment the industry in 2013, and even more were optimistic about their own companies' prospects for the year.

Obamacare is winning

Obamacare is winning-washingtonpost: The Patient Protection and Affordable Care Act — better known as “Obamacare” — is winning. From March 23, 2010, the day it was signed into law, to November 6, 2012, the day President Obama won reelection, the law’s survival was continuously in doubt. House Republicans voted to repeal it more than 30 times. Conservative judges voted to invalidate it. Every Republican presidential candidate promised to get rid of it. But the law endured. It now seems certain to be fully implemented in 2014, as planned. And Republicans are making their peace with it.

Simpson, Bowles' New Deficit Framework Calls For $600 Billion In Health Cuts

Simpson, Bowles' New Deficit Framework Calls For $600 Billion In Health Cuts-insidehealthpolicy:The co-chairmen of the White House's 2010 deficit-reduction panel released a new framework for a deficit reduction plan Tuesday (Feb. 19) that would strip $600 billion from health care spending over 10 years by adjusting benefits to adjust for an aging population, reducing drug costs, means testing Medicare premiums, cutting provider payments and moving forward with other delivery system reforms in 2013. The new Simpson-Bowles proposal requires additional health care reforms if necessary to limit per beneficiary health care spending to near the growth rate of the economy in 2018.

MEDEC analysis: Increased review times at Health Canada

MEDEC analysis: Increased review times at Health Canada-massdevice: An analysis Health Canada data by Canadian medical device trade association MEDEC has found increasing review times and screening deficiencies for Medical Device License applications during the fourth quarter of 2012. MEDEC claims that among Class II license applications, Health Canada reviewers found 52% of new and 10% of amended applications to have screening deficiencies during Q4 2012.

How The Sequester Could Affect Health Care

How The Sequester Could Affect Health Care-npr: It's looking increasingly likely that $85 billion of automatic federal budget cuts known as a sequester will come to pass if Congress doesn't act by March 1.Congress and President Obama agreed on the cuts, which will be divided evenly between defense and domestic programs, including health care, back in the summer of 2011 as part of a last-ditch effort to force a deficit-reduction deal and avert a debt limit default.

Simpson, Bowles eye deeper health care reforms

Simpson, Bowles eye deeper health care reforms-politico: A four-page outline of the latest deficit-cutting plan by Erskine Bowles and Alan Simpson released Tuesday calls for $600 billion in health care spending cuts — while also asserting the need for a “robust, affordable, fair and sustainable safety net.”

Obama to press Congress again for sequester fix

Obama to press Congress again for sequester fix-politico: Obama is due to speak at 10:45 a.m. ET in the South Court Auditorium in the Eisenhower Executive Office Building where, a White House official said, he "will challenge Republicans to make a very simple choice: do they protect investments in education, health care and national defense or do they continue to prioritize and protect tax loopholes that benefit the very few at the expense of middle and working class Americans?"

Will discounted 'doc fix' fly off the shelf?

Will discounted 'doc fix' fly off the shelf?-politico: The price of a permanent “doc fix” was put on deep discount last week and lawmakers appear tempted to buy. The Congressional Budget Office said that repeal of the Sustainable Growth Rate — the antiquated formula that frequently calls for major cuts in Medicare reimbursement payments and requires continual patches from Congress — would cost $138.3 billion.

GOP lawmakers don’t fear political impact of sequester taking effect

GOP lawmakers don’t fear political impact of sequester taking effect-thehill: House GOP lawmakers say they do not fear political blowback if Congress fails to prevent $85 billion in automatic spending cuts from triggering in two weeks. The cuts known as the sequester are almost certain to hit the Pentagon and non-defense discretionary spending on March 1, and congressional Republicans and the White House are focused more now on avoiding blame for the cuts than preventing them.

Report ties 100-plus cyberattacks on U.S. computers to Chinese military

Report ties 100-plus cyberattacks on U.S. computers to Chinese military-washingtonpost: BEIJING — A U.S. security firm has linked more than a hundred cyberattacks on U.S. corporations to China’s military, according to a report released Tuesday. The 60-page study by investigators at the Alexandria-based Mandiant security firm presents one of the most comprehensive and detailed analysis to date tracing corporate cyber-espionage to the doorstep of Chinese military facilities. And it calls into question China’s repeated denials that its military is engaged in such activities.

Healthcare reform: What should the medical device industry expect from the Sunshine Act?

Healthcare reform: What should the medical device industry expect from the Sunshine Act?-massdevice: A primer for the medical device industry on the final Sunshine Act rules governing payments to physicians from Jonathan Kellerman, compliance and risk management expert at PricewaterhouseCoopers.

NCQA Issues First ACO Accreditations

NCQA Issues First ACO Accreditations-healthleadersmedia: Saying "we don't want to have organizations mess up the concept," the National Committee of Quality Assurance president last week announced that six physician-hospital networks are the first to receive accreditation that they qualify as true accountable care organizations."If we really want to maximize the chance of success of the ACO concept, we have to make sure everyone who is a player is capable of being one," said Margaret O'Kane. "We've lived through periods when we've had managed care backlash and so forth, and sometimes, it's because we had organizations that weren't doing the right thing."

The Four Ways That Obamacare Could Still Be Destroyed

The Four Ways That Obamacare Could Still Be Destroyed-buisnessinsider: Now that Obamacare has survived at the Supreme Court and the ballot box, proponents and opponents of the law agree it’s here to stay. But Republicans remain committed to botching its implementation, which — along with inherent complexities in implementing parts of the law — leaves in place significant obstacles to achieving its key goals.

Device Makers Seek Clarity On CMS' Plans For Coverage With Evidence Development

Device Makers Seek Clarity On CMS' Plans For Coverage With Evidence Development-thegraysheet: The agency has posted the 27 comments it received on the new CED draft guidance. The document was released on Nov. 29 and comments on it were due Jan. 28. (See "CMS Redefines Coverage-With-Evidence-Development In Draft Guidance" — "The Gray Sheet," Dec. 3, 2012.) Once finalized, the new policy will replace the 2006 policy on coverage with evidence development, explaining how and under what circumstances CMS expects to impose data-collection requirements in national coverage determinations.

Stakeholders Evaluate Impact Of Bundled Payment Initiative On Devices, Patient Care

Stakeholders Evaluate Impact Of Bundled Payment Initiative On Devices, Patient Care-thegraysheet: Last month, CMS selected the participating health care organizations in its new Bundled Payment for Care Improvement initiative to test how bundling payments for episodes of care can result in more coordinated care for beneficiaries and lower costs for Medicare. Stakeholders affected by the new initiative weighed in on whether the program will affect decisions over which medical devices to use in the episodes of care identified, as well as whether there are adequate quality measures in place to ensure patient care will not suffer.

New U.S. medical device tax on manufacturers and importers

New U.S. medical device tax on manufacturers and importers-massdevice:  Many clients ask us about the new US Medical Device Excise Tax (MDET), so we wanted to provide a brief overview of the tax, which products it impacts and when payments are due. You can read a more detailed explanation of the tax by downloading our White Paper on the Medical Device Excise Tax.

Republicans predict sequester will happen

Republicans predict sequester will happen-politico: Top congressional Republicans predicted Wednesday that the sequester will hit at the end of the month – the latest chapter in the series of budget battles that have stymied Washington in the last few years. Missouri Sen. Roy Blunt, a member of Senate Republican leadership, said “I think the sequester’s gonna happen” and said the Pentagon needs more discretion to target the budget cuts so they don’t hit defense programs indiscriminately.

Medical device tax: Medtech seeks state-level relief from federal levy

Medical device tax: Medtech seeks state-level relief from federal levy-massdevice: Medical device makers are looking to their state regulators to help offset the burden of a new federal tax. National medtech lobby AdvaMed joined forces with the State Medical Technology Alliance, a network of state-based industry groups, to develop state-level regulatory policies that they believe "foster an environment of growth and patient access to the latest in medical innovation."

FDA To Issue UDI Database Draft Guidance In March

FDA To Issue UDI Database Draft Guidance In March-graysheet: The draft guidance will serve as a user’s guide to the soon-to-be-released unique device identifier database, providing definitions for the device elements and attributes that companies have to submit to the database.

House GOP Seek Input On Risk & Reward, Physician Reporting To Flesh Out 'Doc Fix'

House GOP Seek Input On Risk & Reward, Physician Reporting To Flesh Out 'Doc Fix'-insidehealthpolicy:  Key House panels are seeking advice from providers on how a new Medicare physician payment system that bases payment on quality performance would take into account differences among specialties and whether they think some form of risk and reward should be tied to performance on quality care measures, according to documents obtained by Inside Health Policy. The questionnaire, which seeks to fill out the House Ways & Means and Energy & Commerce committees' joint proposal to repeal and replace the Sustainable Growth Rate, was distributed to stakeholders during Friday meetings held by staff from the two committees.

W.H.: We have a spending problem

W.H.: We have a spending problem-politico:"Of course the president believes that we have a spending problem," Carney said at a White House briefing, adding that the problem "is specifically driven by -- and I think every economist worth, whose insights into this area are worth the paper on which his or her PhD is printed, would tell you that  -- the principle driver, when it comes to spending, of our deficits and debt, are, is health care spending. And that’s just a fact.

Slower Growth of Health Costs Eases U.S. Deficit

Slower Growth of Health Costs Eases U.S. Deficit-newyorktimes:  WASHINGTON — A sharp and surprisingly persistent slowdown in the growth of health care costs is helping to narrow the federal deficit, leaving budget experts trying to figure out whether the trend will last and how much the slower growth could help alleviate the country’s long-term fiscal problems.

Boomerang Patients to Penalize Hospitals Under U.S. Law

Boomerang Patients to Penalize Hospitals Under U.S. Law-bloomberg: Fines are being levied against hospitals with high rates of patient readmissions under a provision of the Affordable Care Act targeting $8 billion in Medicare cost savings within six years. That has hospitals across the country going the extra mile to prevent the return of these boomerang patients. Tenet gets in touch with former patients after they’ve been released, urging them to keep doctor appointments. It also provides free medicine to some patients who can’t afford prescriptions and contacts pharmacies to make sure pills are ready for pick-up.

Companies Dig Into Sunshine Rule Details In Preparation For Aug. 1 Go-Live Date

Companies Dig Into Sunshine Rule Details In Preparation For Aug. 1 Go-Live Date-thegraysheet: CMS has finalized several sunshine rule provisions: the definition of “applicable manufacturer” has been narrowed; many payments to speakers at continuing medical education programs and events need not be reported; and the agency will allow manufacturers to supply contextual information on the public database.

FDA seeks comment on device detention rules

FDA seeks comment on device detention rules-massdevice: Last year, the FDA asked the public for more information about risky or harmful devices but didn't receive a single comment. The watchdog agency is now extending the information-gathering procedures for banning a device.

White House: Sequestration Would Delay Drug Approval; Compromise FDA User Fee Goals, Food Safety

White House: Sequestration Would Delay Drug Approval; Compromise FDA User Fee Goals, Food Safety-insidehealthpolicy: The White House Friday (Feb. 8) said sequestration would delay drug approvals, slash food safety inspections and hinder recently negotiated drug and device user fee goals if the across-the-board cuts are not averted. FDA is exploring cost-containment solutions such as using remote work plans, evaluating contracts to reduce duplication and leveraging expertise through various consortia, FDA Commissioner Margaret Hamburg told agency funding advocates this week. The strategies emerge in a tight fiscal climate that includes a continued standoff between President Barack Obama and Congress over the looming threat of sequestration set to take effect in less than a month.

Cantor: Obama's only answer to sequestration is tax increases

Cantor: Obama's only answer to sequestration is tax increases-politico: House Majority Leader Eric Cantor on Sunday slammed President Barack Obama's call for tax increases to delay tens of billions of dollars of spending cuts under sequestration that kick in on March 1. "The problem is every time you turn around, the answer is to raise taxes," Cantor said on NBC's "Meet the Press." "He just got his tax hike on the wealthy. And you can't in this town every three months raise taxes. Again, every time, that's his response."

Pelosi: 'We've had plenty of spending cuts'

Pelosi: 'We've had plenty of spending cuts'-politico: House Minority Leader Nancy Pelosi says the tens of billions of dollars of spending cuts under sequestration that kicks in on March 1 can be avoided through eliminating tax subsidies for oil companies. "The fact is we've had plenty of spending cuts, $1.6 trillion in the Budget Control Act. What we need is growth," Pelosi said in an interview on "Fox News Sunday." Slashing spending indiscriminately, she said, would hurt growth prospects for the U.S. economy.

Obama’s State of the Union: Aggressive

Obama’s State of the Union: Aggressive-politico: President Barack Obama’s State of the Union speech will be less a presidential olive branch than a congressional cattle prod. Emboldened by electoral victory and convinced the GOP is unwilling to cut deals, Obama plans to use his big prime-time address Tuesday night to issue another broad challenge at a Republican Party he regards as vulnerable and divided, Democrats close to Obama say.

Docs wring hands over new Sunshine Act rules

Docs wring hands over new Sunshine Act rules-massdevice: MASSDEVICE ON CALL — More than half of doctors surveyed reported concerns about the new Physician Payments Sunshine Act that the White House released, according to a survey by communications technology company MMIS.

STS, ACC Gain IDE Approval To Study New Access Methods For Edward’s Sapien Valve

STS, ACC Gain IDE Approval To Study New Access Methods For Edward’s Sapien Valve-thegraysheet: The Society of Thoracic Surgeons and American College of Cardiology gained investigational device exemption approval from FDA this week to study unapproved “alternative access” techniques for Edwards Lifesciences Corp.’s Sapien transcatheter valve in inoperable patients with severe aortic stenosis. The goal of the effort is to gain reimbursement for an expanded set of procedures with Sapien to make the device accessible to more patients. 

CMS Expects ACA's Basic Health Program To Be In Place 2015 At Earliest

CMS Expects ACA's Basic Health Program To Be In Place 2015 At Earlies-insidehealthpolicy:  CMS confirmed that the health reform law's voluntary Basic Health Program would be operational in 2015 at the earliest because the agency will not finalize rules on the program until next year. In a FAQ document published Wednesday (Feb. 6), CMS says that it expects to issue proposed rules on the program this year and finalize guidance in 2014 so that states could pursue the option in 2015, a year after the 2014 implementation date of the ACA's major market reforms.

'Doc Fix' Debate Heats Up As Two House Panels Jointly Push SGR Repeal Plan

'Doc Fix' Debate Heats Up As Two House Panels Jointly Push SGR Repeal Plan-insidehealthpolicy: Republicans on two key House health care committees made it clear Thursday (Feb. 7) they plan to work collaboratively on a new Medicare physician payment system after jointly floating a multi-tiered SGR repeal proposal, and Inside Health Policy, which obtained the proposal last week, has learned that Energy and Commerce and Ways and Means staff will meet with several provider stakeholders Friday (Feb. 8) to discuss their straw-man plan.

Device tax repeal gains bipartisan backing

Device tax repeal gains bipartisan backing-politico: A bipartisan bill to repeal the medical device tax was introduced in the Senate on Thursday afternoon, the first time the effort has drawn Democratic co-sponsors in that chamber. Sponsored by Sens. Orrin Hatch (R-Utah) and Amy Klobuchar (D-Minn.), the bill comes a day after a companion bill was introduced by Reps. Erik Paulsen (R-Minn.) and Ron Kind (D-Wis.) in the House. That bill had 175 co-sponsors, including 20 Democrats.

CMS' Final Physician Sunshine Rule Gives Companies Until August To Collect Data

CMS' Final Physician Sunshine Rule Gives Companies Until August To Collect Data-insidehealthpolicy: Following months of pressure to release the health reform law's long-delayed physician-payment disclosure final rule, the Obama administration on Friday (Feb. 1) unveiled a final regulation that gives companies until August to start collecting data, allows physicians additional time to make corrections to information and limits reporting requirements for accredited continuing medical education. The release of the long-awaited final rule implementing the Physician Payments Sunshine Act drew praise from stakeholders, and a key lawmaker said he will closely watch the rule's implementation given the delays that have already occurred.

CBPP's Greenstein, Citing Challenges For Deficit Deal, Says Part D Rebates Can't Pass

CBPP's Greenstein, Citing Challenges For Deficit Deal, Says Part D Rebates Can't Pass- insidehealthpolicy: Bob Greenstein, president of the left-leaning Center on Budget and Policy Priorities, recently told an audience of consumer advocates that they need to urge lawmakers -- Democrats in particular -- to refrain from locking in a top-line figure for federal health care savings until it is clear what can be passed to get there, specifically citing the challenge of securing even the $400 billion in savings last proposed by the president considering that roughly a third of that came from a proposal to extend Medicaid drug rebates to Part D. He warned that locking in a number that includes a proposal opposed by Republicans and some key Democrats could force acceptance of alternative cuts that hit low-income beneficiaries

U.S. groups flex their muscles in Brussels

U.S. groups flex their muscles in Brussels-politico: It’s accepted wisdom that Washington is broken. That’s why the hottest spot in the lobbying and advocacy world is suddenly Brussels.Yes, Brussels. While Congress struggles to pass a budget or pay its bills on time — let alone address copyright law, privacy standards or energy policy — activists, lobbyists and nongovernmental organizations have figured out they can get things done in the European Union instead.

Dr. Jonathan Gruber: Can we control costs in healthcare reform?

Dr. Jonathan Gruber: Can we control costs in healthcare reform?-massdevice:  Harvard Law School rounded up a panel of experts to discuss some of the implications of healthcare reform in the 1st annual Health Law in Review panel discussion. Jonathan Gruber, an MIT economist and a healthcare reform advisor to President Barack Obama, said that many of the cost control measure the Patient Protection & Affordable Care Act encourages, such as involving consumers in insurance price-point shopping or promoting provider reimbursement based on health behavior of the enrollees, come with "thorny legal issues."

Medical device tax: We need action by summer, Paulsen says

Medical device tax: We need action by summer, Paulsen says-massdevice:  Rep. Erik Paulsen (R-Minn.), an unrelenting opponent of the medical device tax that took effect at the start of the year, still sees avenues for repeal tied to larger discussions of corporate tax reform.

Docs concerned about gift disclosure rules, survey finds

Docs concerned about gift disclosure rules, survey finds-thehill: Sixty-three percent of doctors are concerned that President Obama's healthcare law will create a publicly accessible database of industry payments to physicians, according to a new survey.  Tech firm MMIS Inc. reported Monday that more than half of doctors were unaware of the so-called "Sunshine Act," written by Sen. Chuck Grassley (R-Iowa) and former Sen. Herb Kohl (D-Wis.), to expose financial relationships between medical practitioners and industry players.

MDMA Will Focus On FDA Performance, Device Tax Repeal In 2013

MDMA Will Focus On FDA Performance, Device Tax Repeal In 2013-thegratsheet: Priorities in 2013 will look a lot like last year's for the Medical Device Manufacturers Association, as the trade group maintains its focus on FDA implementation of the latest user fee agreement and repeal of the medical device excise tax. “We’re going to continue this year on our mission of promoting public health and improving patient care through the advocacy of innovative, research-driven medical device technology,” said Dan Moore, chairman of the MDMA board and CEO of neuromodulation technology firm Cyberonics

Downton Abbey: The medical device industry's unique connection to a hit television show

Downton Abbey: The medical device industry's unique connection to a hit television show-massdevice: Downton Abbey, the hit PBS show about the aristocracyin post-Edwardian-era England, makes millions of viewers' hearts soar, but it might not have happened without the timely support of a heart valve and the generosity of a few prominent medical device industry folk

FDA To Issue Final Device Post-Market Surveillance Plan In February

FDA To Issue Final Device Post-Market Surveillance Plan In February-Thegraysheet: The device center is moving full speed ahead with plans to publish the final version of its national device post-market strategy by late February or early March, after receiving positive feedback on the proposed plan last year. The center will also choose an outside group to run its nascent Medical Device Epidemiology Network.

Checking the vitals of health reform

Checking the vitals of health reform-politico: Most stakeholders in our $2.7 billion health care industry have decided that enough is enough and got on board the train of systemic health care reform. Their hoped-for destination is an affordable, accessible, high-quality health care system for all Americans. And they have concluded that the only way to get there is for everyone to work to flatten the trajectory of health care spending.

House W&M GOP Float Plan For Permanent 'Doc Fix'

House W&M GOP Float Plan For Permanent 'Doc Fix'-insidehealthpolicy: House Ways and Means Committee Republicans are floating a multi-phase plan to permanently replace the Medicare Sustainable Growth Rate physician payment formula with a system that rewards doctors who provide quality and efficient care. The plan, obtained by Inside Health Policy, calls for fully repealing the SGR and freezing payments for a set period of time, noting that freezing payments for 10 years is estimated to cost $245 billion, accompanied by reforms that would not increase the deficit.

Study: Most states not ready for 2014

Study: Most states not ready for 2014-politico: Most states aren’t ready for the health care law’s insurance market reforms going into place next year — and they better get cracking if they don’t want the feds to step in. That’s the takeaway from a new report released Friday by the Commonwealth Fund. Just 11 states and D.C. have taken action to prepare for seven key insurance market reforms that will go into place next year, including guaranteed issue, bans on waiting periods for eligibility, bans on denying coverage to those with pre-existing conditions and limits on out-of-pocket costs.

Jim McDermott: No retreat on health care law

Jim McDermott: No retreat on health care law-politico: In Jim McDermott’s ideal world, health reform would have meant a single-payer health care system. But in Jim McDermott’s real world, he’ll happily defend President Barack Obama’s health care law — and defend is precisely what he expects to do in his new post as the ranking Democrat on the House Ways and Means Health Subcommittee.