MA leak gives boost to political intel rules

MA leak gives boost to political intel rules-politico: A bipartisan pair wants to require dealers in political intelligence to register the same way lobbyists do — especially now that they have a real-life health care example to help make their point. Rep. Louise Slaughter (D-N.Y.) and Sen. Chuck Grassley (R-Iowa) have pushed for registration before, and they are reviving the effort after sensitive information about Medicare Advantage rates moved the stocks last month.

Momentum builds for repealing SGR; could ‘doc fix’ be next?

Momentum builds for repealing SGR; could ‘doc fix’ be next?-cardiologytoday: Since the late 1990s, Medicare payments to participating physicians have been linked to changes in the country’s gross domestic product through the program’s sustainable growth rate (SGR) formula. As readers of this blog are well aware, this formula produces an automatic reduction in payments to physicians if overall program spending exceeds a pre-determined target. Of course, Congress has suspended these automatic cuts each year since 2002 through a series of temporary “doc fixes.” If Congress fails to enact a similar suspension this year, the SGR formula could result in a 24.4% cut in Medicare’s payments to physicians in 2014.

Obamacare Unveiled as California, New York Lead U.S.

Obamacare Unveiled as California, New York Lead U.S.-bloomberg: While politicians in Washington argue over the Affordable Care Act, its ultimate fate is being decided far from Capitol Hill. Amid the periodic repeal votes in Congress and activist campaigns on both sides of the debate, states from New York to California are striving to meet an Oct. 1 deadline to implement the heart of the health-care law, the online insurance “exchanges” meant to enroll millions of Americans.

Switzerland to Allow Its Banks to Sidestep Secrecy Laws

Switzerland to Allow Its Banks to Sidestep Secrecy Laws-newyorktimes: The Swiss government said on Wednesday that it would let its banks sidestep the country’s secrecy laws to disclose names of clients in a move intended to help resolve a long-running dispute with the United States over tax evasion. The decision is a turning point in what has been an escalating conflict between the two countries. Switzerland’s finance minister said the move would probably enable Swiss banks to accept an offer by the United States government to hand over client details in exchange for a promise against future legal repercussions.

Obamacare isn’t going away, so Republicans should work toward reform

Obamacare isn’t going away, so Republicans should work toward reform-washingtonpost: Even after it becomes law, major legislation is always subject to tweaks, additions and reforms. For something as large and sprawling as the Affordable Care Act, changes should be a matter of course. After all, this law promises to transform U.S. health care as provisions are implemented and benefits begin to trickle to ordinary people.

Ignore those polls! (Obamacare edition)

Ignore those polls! (Obamacare edition)-washingtonpost: Look, the Affordable Care Act is unpopular! After all, a new CNN poll finds 43 percent of respondents support Obamacare, while 54 percent oppose it. Look, the Affordable Care Act is popular after all! Or at least government intervention to achieve universal health insurance is popular. Yes, 54 percent oppose the ACA, but almost half of those think it’s not liberal enough

Unions break ranks on ObamaCare

Unions break ranks on ObamaCare-thehill: The United Food and Commercial Workers International Union (UFCW) — a 1.3 million-member labor group that twice endorsed Obama for president — is very worried about how the reform law will affect its members’ healthcare plans.  Last month, the president of the United Union of Roofers, Waterproofers and Allied Workers released a statement calling “for repeal or complete reform of the Affordable Care Act.”

Electronic Health Data Gaining Favor

Electronic Health Data Gaining Favor-wallstreetjournal: The Department of Health and Human Services says it has reached a tipping point as it seeks to steer medical providers away from paper records. Advocates for electronic health records say they have the potential to make medical care safer and more efficient. In 2015, the federal government will start penalizing providers that haven't begun using electronic health records in reimbursements they get for treating patients.

House Republicans retool high-risk pool legislation

House Republicans retool high-risk pool legislation-politico: House Republicans are quietly reshaping a bill to try to pick up more conservative support for legislation on high-risk pools that many in the party had rejected last month, forcing House leaders to cancel a vote at the last minute. At the insistence of conservative Republicans — especially freshmen who ran on a pledge to repeal the health care law — the second version is expected to completely drain the law’s prevention fund and redirect the dollars to high-risk pools that are run by states.

Potential Donors to Enroll America Grow Skittish

Potential Donors to Enroll America Grow Skittish-washingtonpost:  WASHINGTON — The Obama administration’s efforts to raise private money to carry out the president’s health care law have provoked such a strong partisan uproar that potential donors have become skittish about contributing, according to several people involved in the fund-raising program.

IPAB’s Tough Road: Republicans Opt Not To Help Find Members

IPAB’s Tough Road: Republicans Opt Not To Help Find Members-graysheet: Demonstrating just how difficult it will be to form the Medicare Independent Payment Advisory Board, the top Republicans in the House and Senate have refused to recommend individuals to serve on the Medicare cost-cutting panel, as requested by President Barack Obama. In a May 9 letter to the president, House Speaker John Boehner, Ohio, and Senate Republican Leader Mitch McConnell, Ky., say, “Because the law will give IPAB’s 15 unelected, unaccountable individuals the ability to deny seniors access to innovative care, we respectfully decline to recommend appointments.”

New Metrics For Clinical Trial Oversight Floated By CDRH Entrepreneurs In Residence

New Metrics For Clinical Trial Oversight Floated By CDRH Entrepreneurs In Residence-graysheet: A group of outside experts working inside CDRH has pinpointed significant variability in how FDA approves new clinical trials and is proposing new agency metrics to improve the investigational device exemption process. Efforts by participants in the device center’s entrepreneurs-in-residence program are still under way, but FDA officials have so far been receptive to the group’s critiques and recommendations, according to Chip Hance, an industry veteran who is co-leading an entrepreneurs work group focused on streamlining the FDA clinical trial process for devices.

Boehner shifts from 'law of the land' to repeal again

Boehner shifts from 'law of the land' to repeal again-politico: House Republican leaders are hoping Thursday’s vote to repeal the health reform law will quell substantial pushback, raised particularly by freshman and conservative Republicans, that the House isn’t doing enough to oppose the law, even though repeal is all but impossible now that President Barack Obama has a second term.

Obamacare impacts hiring decisions

Obamacare impacts hiring decisions-washingtonpost: Starting in 2014, Obamacare requires firms with an average of fifty or more full-time workers in the previous calendar year – 2013; this year – to provide health insurance to their employees or face penalties. This creates what economists (and non-economists) describe as an incentive not to hire a fiftieth worker. It may even provide an incentive for firms to let a few workers go if doing so would get them under fifty workers. These poll results suggest that both are happening. . . . So given all this, let me throw something out there: During a labor market crisis, perhaps the government shouldn’t provide a disincentive for small businesses to grow their workforces.

FDA Receptive To Establishing Metrics For Clinical Trials, Says CDRH Entrepreneur

FDA Receptive To Establishing Metrics For Clinical Trials, Says CDRH Entrepreneur-graysheet: Hance, the former president of Abbott Vascular, is among eight outside experts selected last year to work inside CDRH for about six months to identify new approaches to improving the center’s processes, with a focus on three areas: streamlining clinical trials, facilitating reimbursement and better utilizing post-market data in the pre-market setting. An additional five experts have been advising the effort from outside FDA. The 13 experts in total represent the second round of the entrepreneurs-in-residence program. (See "CDRH Entrepreneurs Take Two: Streamlining Data Collection And The Path To Reimbursement" — "The Gray Sheet," Oct. 22, 2012.)

French recession is more bad news for medical device industry in Europe

French recession is more bad news for medical device industry in Europe-massdevice: 

Eurostat, the statistical office of the European Union, said yesterday that the gross domestic product of the 17-nation alliance contracted 0.2% during the first 3 months of 2013 compared to the previous quarter and 1% compared to the same period last year.

Marilyn Tavenner approved by Senate for CMS post

Marilyn Tavenner approved by Senate for CMS post-politico: Tavenner’s nomination to lead the Centers for Medicare & Medicaid Services passed the Senate in a 91-7 vote, with some Republicans using the vote to lodge opposition to her role in implementing the president’s health reform law.

Finance Urged Not To Leave Scraps Of Physician Fee-For-Service Pay Model

Finance Urged Not To Leave Scraps Of Physician Fee-For-Service Pay Model-insidehealthpolicy: Witnesses emphasized to Senate Finance members on Tuesday (May 14) that Congress should entirely do away with fee-for-service Medicare for physician reimbursement after the committee sent a letter to providers stating that some physicians may always need fee-for-service. A Finance staffer said committee members have not decided whether to cut fee-for-service pay for those who remain in that system, as is the plan in the House.

D.C. turns on Obama

D.C. turns on Obama-politico: Republicans have waited five years for the moment to put the screws to Obama — and they have one-third of all congressional committees on the case now. Establishment Democrats, never big fans of this president to begin with, are starting to speak out. And reporters are tripping over themselves to condemn lies, bullying and shadiness in the Obama administration.

House to Vote Yet Again on Repealing Health Care Law

House to Vote Yet Again on Repealing Health Care Law-newyorktimes: WASHINGTON — The 37th time won’t be the charm. But House Republicans are charging forward anyway this week on a vote to repeal President Obama’s signature health care overhaul, which will put the number of times they have tried to eliminate, defund or curtail the law past the three-dozen mark.

Scandal politics sweep Capitol Hill

Scandal politics sweep Capitol Hill-politico: The most recent scandal to grip the Obama administration came Monday evening, when The Associated Press disclosed that the Justice Department sought its reporters’ phone records — including those of correspondents who sit in the Capitol. Within hours, House Republicans vowed to investigate. To make things worse for President Barack Obama, Attorney General Eric Holder is scheduled to be on Capitol Hill Wednesday for a House Judiciary Committee hearing.

Staff shakeup underway at Russian medical device regulator

Staff shakeup underway at Russian medical device regulator-massdevice: According to Russian news sources*, Roszdravnadzor ‘s registration office has been temporarily closed as authorities investigate allegations of bribery among senior officials. The government plans to assemble a new team of personnel for the Roszdravnadzor registration division, and also intends to review all medical device Registration Certificates previously issued by the agency.

Super PAC to air pro-Mitch McConnell ad

Super PAC to air pro-Mitch McConnell ad-politico: The super PAC supporting Senate GOP Leader Mitch McConnell’s reelection is going up with its first commercial Friday, touting the Kentucky Republican’s opposition to the Affordable Care Act. “On health care, Mitch McConnell’s stood with Kentuckians from Day One,” says an announcer in the spot, aired by the Kentucky Opportunity Coalition. “Tell him keep fighting to stop Obamacare in its tracks.”

Republicans Refuse to Name Members to Healthcare Panel

Republicans Refuse to Name Members to Healthcare Panel-medscape: WASHINGTON, May 9 (Reuters) - In a largely symbolic move, Republican leaders in Congress told President Barack Obama on Thursday that they will not participate in picking members of a controversial healthcare panel intended to restrain cost growth in the Medicare health insurance program for the elderly and disabled.

FDA Considers Reducing UDI Direct Marking Requirements For Implants

FDA Considers Reducing UDI Direct Marking Requirements For Implants-thegraysheet: Jay Crowley, FDA’s senior advisor for patient safety and the lead official on the developing UDI program, provided an overview of some of FDA plans for the upcoming final UDI rule during a May 1 session at the Medical Device Conference, co-sponsored by FDA and Xavier University in Cincinnati. The proposed rule was released last July, and FDA received more than 250 comments, some of which made convincing arguments for changes, Crowley said.

Opinion: Republicans to sick people: Tough luck

Opinion: Republicans to sick people: Tough luck-wasingtonpost: There was a striking Republican stumble on health care the other day that deserves to be parsed because it reveals so much about the party’s current dilemma. I’m talking about the tea party revolt that embarrassed House Majority Leader Eric Cantor (R-Va.) and forced him to withdraw a modest bill to bolster the high-risk insurance pool meant to help sick Americans until Obamacare’s insurance exchanges are up and running next year.

Opinion:Obama’s claim that 90 percent of Americans ‘don’t have to worry’ about ‘Obamacare’

Opinion: Obama’s claim that 90 percent of Americans ‘don’t have to worry’ about ‘Obamacare’-washingtonpost: During the president’s news conference on the 100th day of his second term, he rebutted suggestions that the implementation of the Affordable Care Act, a.k.a. “Obamacare,” in the coming year might face problems. He made the argument that most Americans — “the 85 to 90 percent of Americans who already have health insurance” — will not notice anything but better health care, such as coverage for children under the age of 26 and no restrictions because of preexisting conditions.

Opinion:Morning Bits

Opinion: Morning Bits- washingtonpost: Yowser. About the president’s insistence that Obamacare implementation is not a train wreck, as Sen. Max Baucus (D-Mont.) claimed: “By saying that the health care law was already delivering so many great benefits to 85 percent of the country and they don’t even know it, Obama was just reinforcing Baucus’s point. Beyond that, it’s false for Obama to suggest that implementation of the law next year won’t affect anybody other than those who are currently uninsured. In reality, new taxes kick in next year along with the individual mandate, changes to Medicare, fines on businesses that do not offer health insurance, new insurance regulations that will drive up the cost of premiums, along with a myriad of other provisions with wide-ranging impact.” But great answer, otherwise.

Health Care Law Is ‘Working Fine,’ Obama Says in Addressing Criticism

Health Care Law Is ‘Working Fine,’ Obama Says in Addressing Criticism-newyorktimes: The law represents one of the biggest changes in domestic policy in decades, as significant in some ways as the creation of Social Security or Medicare. But at a news conference on Tuesday, Mr. Obama suggested that most Americans would not be affected by changes taking effect next year. And some of his comments may lower public expectations.