Friday, February 27, 2015

Prices For 70 Health Care Procedures Now Online

Prices For 70 Health Care Procedures Now Online-kaiserhealthnews: The actual price of many health care procedures is now available online.

Cyberonics and Sorin, Medical Device Makers, to Merge

Cyberonics and Sorin, Medical Device Makers, to Merge-thenewyorktimes: Two device makers Cyberonics and Sorin are merging. Cyberonics is currently based in Houston, and Sorin in Milan, but the combined business will be headquartered in Britain which has a lower tax rate.

House GOP Faces Another Whip Test on DHS Punt

House GOP Faces Another Whip Test on DHS Punt-rollcall: When in doubt, punt. That’s the latest plan from House Republicans, but even trying to pass a tried-and-true congressional maneuver might be a tall order for the GOP’s fractured conference. They met again in the Capitol basement Thursday night and settled on a game plan: a three-week continuing resolution stripped of all provisions blocking President Barack Obama’s immigration action, as well as a separate motion to go to conference with the Senate.

Thursday, February 26, 2015

After Deadly Infections, F.D.A. Asks Device Makers About Cleaning Methods

After Deadly Infections, F.D.A. Asks Device Makers About Cleaning Methods-thenewyorktimes: The FDA wants more information about how device manufacturers recommend disinfecting duodenoscopes, which are responsible for drug-resistant infections in seven patients.

Clinical Trial Diversity: ‘How Much More Evidence Do We Need To Move Forward?’

Clinical Trial Diversity: ‘How Much More Evidence Do We Need To Move Forward?’-thegraysheet: FDA seeks research ideas and plans to include demographic subgroup analyses in review templates as some stakeholders call for bolder action to change how companies conduct clinical trials.

Lawmakers Reintroduce Bill To Prevent FDA User Fee Sequestration

Lawmakers Reintroduce Bill To Prevent FDA User Fee Sequestration-thegraysheet: House representatives are again making a bipartisan bid to prevent FDA user fees from being withheld in a potential sequestration as the administration and Congress come to loggerheads over the president's new budget.

Wednesday, February 25, 2015

Brookings Lays Out Seven-Year Plan To Utilize Medical Device Postmarket Surveillance System

Brookings Lays Out Seven-Year Plan To Utilize Medical Device Postmarket Surveillance System-insidehealthpolicy: A new Brookings Institution report sets out a seven-year plan for stakeholders to fully adopt and implement an effective postmarket surveillance system for medical devices (MDS).

IRS Won’t Collect Additional Taxes From Filers Who Used Incorrect Forms

IRS Won’t Collect Additional Taxes From Filers Who Used Incorrect Forms-wallstreetjournal: The Internal Revenue Service won’t collect any additional taxes from about 50,000 people who already have filed returns using an incorrect government form on their coverage under the federal health insurance exchange. The Treasury official said the agency also is considering similar relief for consumers in state-run exchanges who may have filed their returns using incorrect statements.

Little Hope for Immediate Obamacare Fix as Supreme Court Ruling Looms

Little Hope for Immediate Obamacare Fix as Supreme Court Ruling Looms-nbcnews: Neither the Obama administration nor the states nor Congress is taking aggressive action to fix a potential problem with the Affordable Care Act, even with a Supreme Court decision looming that could raise the prices for health insurance for more than 6 million people in 34 states.

Fancy Flourishes At Hospitals Don’t Impress Patients, Study Finds

Fancy Flourishes At Hospitals Don’t Impress Patients, Study Finds-kaiserhealthnews: Kaiser Health News reports that fancier hospitals don't lead to better patient reviews.

Tuesday, February 24, 2015

Sen. Hatch promises 'solutions' to Obamacare subsidy fallout

Sen. Hatch promises 'solutions' to Obamacare subsidy fallout-cnbc: Sen. Orrin “Hatch said that while Obamacare has hurt millions of people … Congress should do something in the meantime to mitigate the effects if the high court decides to invalidate that financial aid. ‘In the coming days, I will release details of a short-term solution for Americans who may be affected,’ Hatch said. ‘That solution will address immediate concerns and set the stage for a permanent solution in the future.’”

Planning Board Proposes Postmarket Device Surveillance Timeline

Planning Board Proposes Postmarket Device Surveillance Timeline-thegraysheet: A planning board created to develop a framework for a new U.S. medical device surveillance system has proposed a seven year plan on how to get the system up and running, which will include creating incentive systems for stakeholders as well as reducing the burden of recording and managing device data.

Senate HELP Launches "Innovation" Working Group To Consider Device Reforms

Senate HELP Launches "Innovation" Working Group To Consider Device Reforms-thegraysheet: The Senate Health, Education, Labor and Pensions Committee has formed a bipartisan "Innovation Working Group" that will re-examine device and drug regulatory programs, with an eye to getting innovative products to market more quickly.

Monday, February 23, 2015

’Defect in code’ means bum Obamacare info for 800,000 taxpayers

’Defect in code’ means bum Obamacare info for 800,000 taxpayers-politicopro: The 800,000 Americans who’ve just gotten erroneous tax forms for their Obamacare subsidy can blame a glitch in HealthCare.gov that used the wrong year’s data for the calculations. Precisely how and where that mistake was made is still being investigated.

Obama Administration Disallows Plans Without Hospital Coverage

Obama Administration Disallows Plans Without Hospital Coverage-kaiserhealthnews: The Obama administration has blocked health plans without hospital benefits that many large employers argued fulfilled their obligations under the Affordable Care Act.

Hospitals face closures as 'a new day in healthcare' dawns

Hospitals face closures as 'a new day in healthcare' dawns-modernhealthcare: Hospital admissions are falling as patients look to clinics and home care, and hospitals are closing or shrinking across the board.

Thursday, February 19, 2015

U.S. Health-Care Spending Is on the Rise Again

U.S. Health-Care Spending Is on the Rise Again-bloomberg: The national medical bill may be back to growing faster than gross domestic product. After five years of historically slow growth, new data show U.S. health-care spending accelerated significantly in 2014.

8 Tax Loopholes the Obama Administration Could Close

8 Tax Loopholes the Obama Administration Could Close-newyorktimes: The New York Times published an opinion piece about how President Barack Obama’s State of the Union address showed how assertiveness is “sorely lacking” in the tax policy world and listed eight tax loopholes the president’s administration could close.

Wednesday, February 18, 2015

Hospital Discharges Rise at Lucrative Times - WSJ

Hospital Discharges Rise at Lucrative Times - WSJ: "Under Medicare rules, long-term acute-care hospitals like Kindred’s typically receive smaller payments for what is considered a short stay, until a patient hits a threshold. After that threshold, payment jumps to a lump sum meant to cover the full course of long-term treatment."

Democrats are bracing for another Obamacare backlash

Democrats are bracing for another Obamacare backlash-washingtonpost: The Obamacare window technically just closed this weekend, but a new round of political headaches could just be beginning for the administration. That's because it's tax season, and many Americans could soon be getting an unwelcome surprise that they owe the government a penalty for skipping health insurance coverage.

Wednesday, February 11, 2015

Med device industry quiet on how to pay for repealing tax

Med device industry quiet on how to pay for repealing tax-thehill: Repealing the medical device tax is at the top of the agenda for the Advanced Medical Technology Association this year, but its top officials remain mum about how to make up for the millions of lost dollars under ObamaCare.

Former Hill Staffers: Tax Reform Key To Entitlement Reform; 6-9 Month SGR Patch Likely

Former Hill Staffers: Tax Reform Key To Entitlement Reform; 6-9 Month SGR Patch Likely-insidehealthpolicy: Entitlement reform will need to be part of a larger package that could include a mix of Medicare structural reform, provider reimbursement cuts and money in savings from the Affordable Care Act, former House Ways and Means health subcommittee majority staff director Dan Elling said Tuesday (Feb. 10) at the National Health Policy Conference.

Tuesday, February 10, 2015

Supreme Court Obamacare case poses political peril for GOP

Supreme Court Obamacare case poses political peril for GOP-politicopro: The Supreme Court could be months away from blowing a huge hole in Obamacare — and Republicans on Capitol Hill are at odds over how they’ll respond if their side wins. It’s the latest example in a long-running quandary for Republicans: They don’t agree on what alternative, if any, their party should offer to President Barack Obama’s signature health care law. But the issue is taking on new urgency for the GOP congressional leaders as the court takes up a case that could leave more than 5 million people without Obamacare’s crucial subsidies.

Cures Draft Proposes FDA, NIH Advisory Panel Patterned After MedPAC

Cures Draft Proposes FDA, NIH Advisory Panel Patterned After MedPAC-insidehealthpolicy: House lawmakers' 21st Century Cures Initiative draft bill calls for creation of a congressional advisory commission tasked with recommending policies to accelerate discovery, development and delivery of new medical products, akin to the Medicare and Medicaid commissions that currently advise Congress on those programs.

Monday, February 9, 2015

Evidence Bar Rising For Medicare Reimbursements, Tufts Study Says

Evidence Bar Rising For Medicare Reimbursements, Tufts Study Says-thegraysheet: It's getting harder to win reimbursement coverage for devices and drugs under national coverage determinations as CMS asks for increasingly more data, according to a Tufts Medical Center study released in Health Affairs Feb. 2

How Obama’s Tax Plan May Not Work as Intended

How Obama’s Tax Plan May Not Work as Intended-newyorktimes: Companies’ offshore cash holdings are a tempting target for American tax writers, as President Obama’s proposal this week to tax deferred offshore earnings proves. Those same offshore earnings may attract foreign buyers as well. A Bloomberg article on Wednesday by David Kocieniewski rightly identifies an unintended consequence of the president’s proposal: It provides companies with an additional incentive to hurry up and move their headquarters overseas before the rules change.

FDA chief stepping down

FDA chief stepping down-politicopro: FDA Commissioner Margaret Hamburg, who has overseen food and drug safety for nearly six years, will leave at the end of March, she announced in an email to agency staff Thursday morning.  Stephen Ostroff, the FDA’s chief scientist, will be acting commissioner when Hamburg steps down, her email said.

Dem Lobbyist Notes GOP's Bill Borrows Key Parts Of ACA; Hatch Says Pieces Offer Path Forward

Dem Lobbyist Notes GOP's Bill Borrows Key Parts Of ACA; Hatch Says Pieces Offer Path Forward-insidehealthpolicy: As key Democrats and patient advocates blast the GOP's Obamacare alternative, a Democratic lobbyist and former Senate staffer who helped craft the health law says the Republican plan is so much like the ACA that Congress' time would be better spent figuring out substantive ways to improve the system rather than repealing and replacing it with similar policies. The sponsors of the GOP bill introduced Wednesday (Feb. 4) also signaled ideas from the measure could be adapted to provide a path forward should the Supreme Court rule that subsidies aren't available in federally facilitated exchanges.

Thursday, February 5, 2015

Hatch Says CMS Should Break From HHS As Finance Questions Burwell On Budget

Hatch Says CMS Should Break From HHS As Finance Questions Burwell On Budget-insidehealthpolicy: Senate Finance Committee Chair Orrin Hatch (R-UT) called for CMS to be set up as an independent agency as lawmakers questioned HHS Secretary Sylvia Burwell Wednesday (Feb. 4) on a wide range of policies both in the president's budget and outside it.

Here’s how the GOP would repeal and replace Obamacare

Here’s how the GOP would repeal and replace Obamacare-washingtonpost: The plan, presented by Sens. Richard Burr (R-N.C.) and Orrin Hatch (R-Utah) and Rep. Fred Upton (R-Mich.), is in part intended to help manage any potential chaos from a pivotal Supreme Court ruling expected later this year that could invalidate subsidies for federal-run health insurance exchanges across the country.

Democrats Might Need to Lose the White House to Win the House Majority

Democrats Might Need to Lose the White House to Win the House Majority-rollcall: “It’s going to be awhile,” wrote The Washington Post’s Chris Cillizza recently, summarizing Democrats’ chances of obtaining a majority in the House. But Democrats may not need years to dig out from their minority hole … if they are willing to surrender the White House in 2016.

Wednesday, February 4, 2015

Senate Pushes Its 'Cures' Plan With Bipartisan Staff Workgroup, March Hearings

Senate Pushes Its 'Cures' Plan With Bipartisan Staff Workgroup, March Hearings-insidehealthpolicy: The Senate health committee's top Republican and Democrat on Tuesday (Feb. 3) announced they will tap a bipartisan staff working group next week and hold hearings in March to advance a medical innovation effort that complements the House's 21st Century Cures Initiative. The hearings will examine the respective roles of FDA and the National Institutes of Health in getting safe treatments, devices and cures to patients, committee chair Lamar Alexander (R-TN) and ranking Democrat Patty Murray (WA) suggested in a joint press release.

3 Republicans say no as House again votes Obamacare repeal

3 Republicans say no as House again votes Obamacare repeal-politico: The House voted 239-186 Tuesday evening to repeal Obamacare — its fourth such vote since the law’s 2010 passage but its first since the GOP took control of Congress. A trio of Republicans voted against the bill: Robert Dold of Illinois, Bruce Poliquin of Maine and John Katko of New York. Of course, the vote is largely symbolic since a full-repeal bill is unlikely to make it through the Senate and, even if it did, President Barack Obama has made it clear he’d veto it.

Monday, February 2, 2015

Cures Draft Includes 510(k)s In Priority Review, Accelerated Approval Provisions

Cures Draft Includes 510(k)s In Priority Review, Accelerated Approval Provisions-insidehealthpolicy: House lawmakers took up a medical device industry suggestion by extending the availability of priority review for breakthrough devices to 510(k)s in their 21st Century Cures draft bill, as well as establishing an accelerated approval pathway for these devices.

GOP chairmen to lead task force to develop Obamacare alternative

GOP chairmen to lead task force to develop Obamacare alternative-politico: Three powerful committee chairmen — including Rep. Paul Ryan — will lead a working group to develop an alternative to Obamacare, the House Republicans’ most serious attempt thus far to develop their health care reform package, according to GOP sources.

Device Industry Grab-Bag Of Provisions In 21st Century Cures Draft

Device Industry Grab-Bag Of Provisions In 21st Century Cures Draft-thegraysheet: Device industry advocates have a lot of reading to do. There are more than two dozen provisions with relevance to the medtech sector, many aimed at smoothing the way for product approvals and reimbursement, in a 21st Century Cures discussion draft unveiled by the House Energy and Commerce panel Jan. 27. The initial proposal does not have bipartisan support.