SGR Discussion Draft Freezes Pay With Opportunities For Bonuses

SGR Discussion Draft Freezes Pay With Opportunities For Bonuses-insidehealthpolicy: The Senate Finance and House Ways & Means committees released an SGR discussion draft Wednesday (Oct. 30) that would freeze doctor pay for 10 years but pay bonuses for good performance, or until 2021 physicians could receive a 5 percent pay increase for participating in "two-sided risk" alternative pay models, including accountable care organizations. That 5 percent bonus would be on top of shared savings that providers stand to earn from those ACOs, according to a copy of the draft obtained by Inside Health Policy. 

Bipartisan, bicameral pathway possible for SGR repeal

Bipartisan, bicameral pathway possible for SGR repeal-politico: The top Republicans and Democrats on the Senate Finance and House Ways and Means committees have agreed on a basic framework for a permanent doc fix, a potentially momentous step in reforming the Medicare payment system.

Hospitals Continue Pushing CMS To Change Two-Midnight Policy

Hospitals Continue Pushing CMS To Change Two-Midnight Policy-insidehealthpolicy: Mount Sinai Health System and 160 hospitals CEOs are not sitting quietly even though CMS' "two-midnight" hospital admissions policy went into effect Oct. 1, writing to Administrator Marilyn Tavenner late last week asking her to suspend the policy and issue sub-regulatory guidance allowing hospitals to continue using medical judgment for admissions expected to last less than two midnights.

Medtech isn't giving up on repealing the medical device tax | MassDevice.com On Call

Medtech isn't giving up on repealing the medical device tax-massdevice:  The country may have moved on from the federal shutdown in which the medical device tax took center stage, but a group of die-hard legislators from states with large medtech clusters are pressing to repeal the 2.3% levy.

AdvaMed: Device Costs Not Cause Of Hospital Charge Variation

AdvaMed: Device Costs Not Cause Of Hospital Charge Variation-thegraysheet: The wide variation in hospital charges has been a hot-button issue since CMS released charge data for 100 of the most common Medicare inpatient procedures in May. While some have pointed to medical device-related procedures as the primary culprit for such variation, a recent industry-sponsored study shows that device-intensive hospital admissions actually had less variability than other admissions.

Senate Finance, House Ways & Means To Introduce Same SGR Bill

Senate Finance, House Ways & Means To Introduce Same SGR Bill-insidehealthpolicy: The Senate Finance and House Ways & Means committees plan to hold separate bipartisan meetings as early as next week to brief members on a joint legislative outline to replace the Sustainable Growth Rate physician payment formula, according to several physician lobbyists and a congressional aide. Leaders of the committees plan to introduce the legislation after getting feedback on the outline from their members and providers, the lobbyists said.

Industry Says MDR Draft Guidance Would Lead To Redundant Reporting

Industry Says MDR Draft Guidance Would Lead To Redundant Reporting-thegraysheet: FDA proposed changes to the MDR system in a draft guidance (PDF) released in July. The draft explains FDA’s regulations for manufacturer adverse event reporting and recordkeeping, and clarifies FDA’s interpretations of the requirements. The guidance also features a new “frequently asked questions” section and a list of common errors made by devices companies in their adverse event reports. Once finalized, it will replace FDA’s 1988 and 1997 MDR guidances.

Task Force Collaborating With FDA Issues Pediatric Heart Valve Recommendations

Task Force Collaborating With FDA Issues Pediatric Heart Valve Recommendations-thegraysheet: The paper is published in the October issue of the Journal of Thoracic and Cardiovascular Surgery, along with a commentary from CDRH staff involved in efforts to promote the development of pediatric devices. “The approach presented in the article is consistent with FDA’s regulatory practices for surgically implanted heart valves, is capable of providing a reasonable assurance of safety and effectiveness, promotes pediatric device development, and represents the least burdensome approach to the important unmet need of pediatric heart valves,” the FDA staffers conclude.

Senate Health Committee chair says medtech tax repeal is a "phony" issue

Senate Health Committee chair says medtech tax repeal is a "phony" issue-massdevice: Medical device tax repeal efforts have made friends across party lines and in both houses of Congress, but Senate Majority Leader Harry Reid isn't one of them. In harsh comments made yesterday Reid characterized the debate over the medical device tax as a fabricated controversy, saying that the industry can afford to pay its share to help fund healthcare reform, Minnesota Public Radio reported.

U.K. regulators requiring public registration of medical device clinical investigations

U.K. regulators requiring public registration of medical device clinical investigations-massdevice: Healthcare regulators in the UK are now requiring medical device manufacturers and sponsors to register their clinical trials in publicly accessible databases such as the EU Clinical Trials Register or ClinicalTrials.gov in the US.

Government Shutdown Causes Backlog Of 100 Device Submissions, With More Expected

Government Shutdown Causes Backlog Of 100 Device Submissions, With More Expected-thegraysheet: The device center announced Oct. 24 that it received 101 device submissions during the 16-day government shutdown, and expects even more in the coming weeks from companies that may have avoided submitting due to the shutdown.During the shutdown, FDA was not allowed to formally accept or log in any user-fee funded device submissions, including PMAs and 510(k)s.Of the 101 submissions that piled up at the agency during the period, 33 were PMAs and 58 were 510(k)s. 

SOFTWARE Act Introduced To Curb FDA Health IT Oversight

SOFTWARE Act Introduced To Curb FDA Health IT Oversight-thegraysheet: Rep. Marsha Blackburn, R-Tenn., and a bipartisan group of colleagues in the House introduced the SOFTWARE Act Oct. 22 to redefine the regulation of health information technology, with the probable effect of deregulating much of the sector. Besides Blackburn, the bill is cosponsored by Reps. Gene Green, D-Texas, Phil Gingrey, R-Ga., Diana DeGette, D-Colo., Greg Walden, R-Ore., and G.K. Butterfield, D-N.C. “Under current law, the FDA could use its definition of a medical device to assert broad regulatory authority over a wide array of software,” the lawmakers noted in a statement unveiling the legislation. “The SOFTWARE Act tailors their authority to the realities of the 21st century by focusing their authority onto the products that pose a potential risk to human health.

Democrats rally around health-care law

Democrats rally around health-care law-washingtonpost: Overall, 45 percent of Americans back the health-care law -- up from 41 percent in August -- while 50 percent oppose it. Opposition to the law has consistently been higher than support for it. That increase in support is almost exclusively because of Democrats. While 71 percent of Democrats backed the law in August, 83 percent support it now. Nearly all of the 12 percent of Democrats who had expressed no opinion of the law in August now support it.

FDA Hopes Not To Repeat Exchange Portal Glitches With UDI Database

FDA Hopes Not To Repeat Exchange Portal Glitches With UDI Database-insidehealthpolicy: FDA plans to launch a global database to store Unique Device Identifier information in 2014 but is being careful about how it "rolls out" the database given technical issues plaguing other federal websites, according to an agency official. The agency has no idea how many people will use the database or how many devices will be registered to the site and would like to be sure that it has the bandwidth needed to ensure the system works smoothly, said Jay Crowley, senior advisor for patient safety in FDA's device center. He added, however, that the staggered compliance deadlines for UDI implementation  should help the agency address any issues.

Ryan blasts Sebelius on Obamacare testimony

Ryan blasts Sebelius on Obamacare testimony-politico: House Budget Committee Chairman Paul Ryan (R-Wis.) says HHS Secretary Kathleen Sebelius has stonewalled his committee and the public on Obamacare. Ryan says the secretary has refused repeated requests for information on implementation of the health law and invitations to testify in front of his committee.

Obama: 'I'm asking you to be a part of Team Obamacare.'

Obama: 'I'm asking you to be a part of Team Obamacare.'-politico: President Barack Obama is trying to rev up his political supporters to back the White House health care outreach. In a YouTube video sent to members of his political arm Tuesday, Organizing for Action, Obama made a direct appeal to help register people for health care and explain that the administration’s bungled online rollout doesn’t mean the entire law is flawed.

EU Parliament Approves Compromise On Device Reforms – But Will It Be Enacted?

EU Parliament Approves Compromise On Device Reforms – But Will It Be Enacted?-thegraysheet:  The EU Parliament plenary approved compromise legislation for medical devices and in vitro diagnostics Oct. 22 that appeared to move away from an industry-opposed centralized oversight plan passed out of committee last month. Although specific details of the final language approved by the Parliament are not yet clear, trade group Eucomed, which came out strongly against amendments approved by the Public Health Committee Sept. 25, says the compromise has “paved the way to achieve balanced EU rules on medical devices.”

Updated eCopy Guidance Clarifies FDA’s Electronic Submission Program

Updated eCopy Guidance Clarifies FDA’s Electronic Submission Program-graysheet: FDA updated guidance on its eCopy program for medical device submissions Oct. 10 to clarify its proper usage to help companies submit electronic versions of device applications to the agency. The revised guidance (PDF) contains some substantive changes and adds clarifications and additional instructions to the previous final guidance issued on Dec. 31, 2012.  Sponsors have been required to submit an eCopy of their submission along with a paper copy since Jan. 1, 2013, Peper Long, CDRH associate director for external relations, told “The Gray Sheet

Tim Scott: Obamacare ‘consistently’ failing

Tim Scott: Obamacare ‘consistently’ failing-politico: Sen. Tim Scott slammed the Affordable Care Act’s online rollout and dismissed claims by President Barack Obama that people are “rooting” for its failure.“I don’t think anyone has to root for failure of Obamacare. Obamacare is consistently and currently failing,” Scott (R-S.C.) said Monday on Fox News’s “On the Record with Greta Van Susteren.”

Addressing The Backlog: Government Shutdown Ends, Now FDA Has To Catch Up

Addressing The Backlog: Government Shutdown Ends, Now FDA Has To Catch Up-thegraysheet: During the 16-day-long government shutdown, the agency continued to review device submissions made by companies prior to Oct. 1, with about half of its employees at work funded by $18.4 million in carryover user fees from fiscal year 2013. (See "$18.4 Million In User Fees Left In CDRH’s Coffers, How Long Will It Last?" — "The Gray Sheet," Oct. 11, 2013.) Reviewers also did some work on new submissions, such as investigational device exemptions, that are not tied to a user fee. But FDA was prevented from accepting any new FY 2014 user-fee funded device submissions, including PMAs and 510(k)s, during the shutdown.

Timing Of Bill To Fund Government Puts SGR In Precarious Position

Timing Of Bill To Fund Government Puts SGR In Precarious Position-insidehealthpolicy: The timeline in the deal to fund the government until Jan. 15 could put Medicare physician payment reform legislation in a precarious position, physician lobbyists say, because the Sustainable Growth Rate formula that cuts Medicare physician pay by 25 percent kicks in Jan. 1. Yet, the Senate deal also sets the stage for a new round of negotiations to cut Medicare spending, which in turn could create another opening for replacing the Medicare pay formula, even though fixing the SGR would increase deficit spending.

Obama wins

Obama wins-politico: In the end, President Barack Obama got exactly what he said he wanted — a debt-limit increase, an extension of the federal government’s funding, and no overly binding strings attached — and he did it by keeping faith with his unusual watchwords: No negotiation. Experience had taught Republicans, and even Democrats, that he would wilt.

GOP blame game: Who lost the government shutdown?

GOP blame game: Who lost the government shutdown?-politico: The government shutdown saga has drawn to an end. The debate within the GOP about who blew it is just beginning. Since before the federal government closed its doors on Oct. 1, leaders within the Republican coalition have been privately – and sometimes not-so-privately – squabbling over who should take the blame for the unfolding political smashup. Some in the party questioned whether a shutdown and debt-ceiling standoff would do noticeable damage to the GOP, but many more always believed this would turn into a prime-time fiasco.

Heritage Action, FreedomWorks oppose House bill

Heritage Action, FreedomWorks oppose House bill-politico: House Republican leadership’s plan to fund the government, raise the debt ceiling and cut health care contributions to Capitol Hill aides and lawmakers didn’t go far enough for conservative groups. Both Heritage Action for America and FreedomWorks urged lawmakers to vote “no” on the House bill, arguing that it does not go far enough on Obamacare. Both conservative groups included the vote on their annual scorecard, with a “yes” voting serving as a blemish on lawmakers' credentials.

Medical device tax major piece in debt talks

Medical device tax major piece in debt talks-politico: The tax has been in and out and in and out of several offers from both Republicans and Democrats to smooth a deal to reopen government and lift the debt ceiling. As of late on Tuesday, it was cut from the latest House Republican offer. It also fell out of a Senate offer from earlier this week.

This is why the medical device tax is in so much trouble

This is why the medical device tax is in so much trouble-washingtonpost: The other reason the medical device tax is weak is it hits a very specific, very organized industry that can mount a very aggressive, and reasonably persuasive, campaign against it. Eckberg attached a document filled with hundreds of testimonials from CEOs and ordinary workers at medical device firms. It's worth reproducing some of them because this is what members of Congress are hearing all day.

Two-Year Delay Of Device Tax Included In House Debt Ceiling Plan

Two-Year Delay Of Device Tax Included In House Debt Ceiling Plan-thegraysheet: The full House is expected to vote later today on a debt ceiling and government funding bill that would include a two-year delay of the medical device tax, according to House GOP conference leaders.“We have a Republican alternative to the Senate bill … it deals with the medical device tax,” said Rep. Darrell Issa, R-Calif., speaking to reporters after emerging from a House GOP conference Tuesday morning.

Tea party still wants Obamacare gutted

Tea party still wants Obamacare gutted-politico: You go through a whole government shutdown so you can kill Obamacare dead, and all you get is a little more due diligence before people can get their subsidies? Tea party groups are furious over the prospect that Congress is drifting toward a government funding-debt ceiling deal that might just take the usual one or two tepid dings out of President Barack Obama’s signature health care law, just like Congress has in previous fights.

Medical device makers flex muscle in debt limit fight

Medical device makers flex muscle in debt limit fight-politico: Several key lawmakers advocating a medical device tax repeal deal to end the current fiscal standoff could be rewarded by more than just a peacemaker reputation. The olive branch they’re offering could boost their campaign coffers. Reps. Ron Kind (D-Wis.), Erik Paulsen (R-Minn.) and Jim Matheson (D-Utah) are among the lawmakers urging their colleagues to end the shutdown stalemate by ditching the new levy, created in 2010 as part of Obamacare.

Medical device tax: Is the White House changing its tone?

Medical device tax: Is the White House changing its tone?-massdevice: After months of stark rejection of any measure to repeal the medical device tax, the White House signaled this week that it may be willing to consider a repeal bill as long as it comes with a pay-for.

Obama: Won’t negotiate ‘with a gun at my head’

Obama: Won’t negotiate ‘with a gun at my head’-politico: President Barack Obama told House Democrats on Wednesday that he would negotiate with Republicans but “not with a gun at my head,” according to one lawmaker who attended a caucus-wide meeting at the White House. As he has before, Obama said he was open to short-term agreements to open the government and raise the debt ceiling if that’s what it took to help Republicans out of what he described as a political box, the lawmaker said.

John McCain: Obamacare fight ‘a fool’s errand’

John McCain: Obamacare fight ‘a fool’s errand’-politico: Sen. John McCain said Wednesday that there was never a chance of defunding Obamacare, blaming politicians who said it was possible for the current government shutdown.“We started this on a fool’s errand, convincing so many millions of Americans and our supporters that we could defund Obamacare,” McCain (R-Ariz.) told Wolf Blitzer on CNN. “[That] obviously wouldn’t happen until we had 67 Republican senators to override a presidential veto.”

Key Republicans signal willingness to back down on effort to defund health-care law

Key Republicans signal willingness to back down on effort to defund health-care law-washingtonpost: Key GOP figures on Wednesday sent their clearest signals that they are abandoning their bid to immediately stop the federal health-care law — the issue that forced the government to shut down — and are scrambling for a fallback strategy. Republican Party leaders, activists and donors now widely acknowledge that the effort to kill President Obama’s signature initiative by hitting the brakes on the government has been a failure. The law has largely disappeared from their calculus as they look for a way out of the impasse over the shutdown and for a way to avoid a possible default on U.S. debt.

Medical-Device Tax Repeal Gains New Life

Medical-Device Tax Repeal Gains New Life-wallstreetjournal: The White House ruled out a tax repeal as a condition for raising the debt ceiling or reopening the government. But even though Republicans have shifted toward seeking spending and tax concessions, rather than changes to the health law, the administration signaled Wednesday it might be willing to include repeal of the device tax later in a different context.

Medical device tax repeal is still in play on Capitol Hill

Medical device tax repeal is still in play on Capitol Hill-massdevice: The medical device tax continues to play a big role in the budget stalemate on Capitol Hill, where lobbyists haven't let go of efforts to repeal the levy. As a $30 billion piece of the funding for the Affordable care Act, the medtech tax has become a political football as warring factions in Congress fight over the debt ceiling.

House Passes FDA Funding Bill, But Not Expected To Go Anywhere

House Passes FDA Funding Bill, But Not Expected To Go Anywhere-thegraysheet: The short-term FDA funding bill, approved 235-162 by the House on Oct. 7, is one of a series of agency-by-agency continuing resolutions and other “mini CRs” that House Republicans have brought forward during the ongoing partial government shutdown. President Obama and Senate Democratic leadership have repeatedly insisted that they will only accept a continuing resolution that funds the entire government, and that does not contain any provisions to rollback or delay portions of the Affordable Care Act.

Is Obamacare still the point?

Is Obamacare still the point?-politicopro: President Barack Obama and his aides are painting GOP leaders as hostage takers and suicide bombers over their shutdown and debt ceiling strategy. House Republicans are pushing the idea that Obama and Democrats are intransigents who refuse to engage in civil discourse on a solution. Senate Democrats are hammering Speaker John Boehner with the president’s call for a House vote on a clean funding bill. And everyone wants to talk about how shutdown pain is hitting home for ordinary Americans.

BREAKING: House votes to fund FDA past shutdown

BREAKING: House votes to fund FDA past shutdown-massdevice: The U.S. House of Representatives voted tonight to fund the FDA until the federal shutdown ends or until Dec. 15, whichever comes first. The lower chamber approved on a 235-162 vote a joint resolution by Rep. Robert Aderholt (R-Ala.) that restores funding to the level established by sequestration, which is about $200 million less than originally authorized.

Are Hospitals More Efficient Than They Seem?-bloomberg

Are Hospitals More Efficient Than They Seem?-bloomberg: Hospitals have been criticized, including by me, as wildly inefficient. Yet two new pieces of evidence suggest that the hospital market may be more efficient than conventional wisdom suggests. Hospitals practice medicine in drastically different ways, and the higher-spending ones don’t seem to generate any better results than those that spend less. Because of third-party insurance and other distortions, though, the market doesn’t punish the inefficient hospitals. That has been the traditional critique.

Health Care Hospitality: Hospitals Use Amenities To Dazzle Patients

Health Care Hospitality: Hospitals Use Amenities To Dazzle Patients arkansasbusiness: “There is an increasing pressure from a business perspective on health care systems and hospitals to be competitive,” said Chad Aduddell, president of St. Vincent Infirmary Medical Center in Little Rock. “And so more and more … hospitals are looking at other industries, other service industries, and trying to replicate some of the things that those hospitality industries have done.”

Medical Device Innovation Center Advances Regulatory Science Projects

Medical Device Innovation Center Advances Regulatory Science Projects-thegraysheet: The Medical Device Innovation Center has formed steering committees on three planned regulatory science projects, and has made the most progress with its computer modeling and simulation project focused on creating computer models that can be shared between industry and FDA. MDIC Board Chairman William Hawkins Oct. 1 discussed the latest project updates at the Regulatory Affairs Professionals Society annual meeting held in Boston Sept. 28-Oct. 2. The government shutdown scrapped a planned virtual presentation from CDRH Director Jeffrey Shuren. 

As U.S. struggles with health reform, the Amish go their own way

As U.S. struggles with health reform, the Amish go their own way-nbcnews: The debate over U.S. healthcare reform that has gripped the nation and led to a government shutdown is of small concern in rural Pennsylvania's Amish country for a very simple reason. Along with eschewing cars and many other modern technologies, the descendants of 18th-Century German immigrants who practice the Amish and Old Order Mennonite religions, have effectively opted out of Obamacare, along with most federal safety net programs.

Clinical trial patients to Congress: 'Stop acting like babies'

Clinical trial patients to Congress: 'Stop acting like babies'-nbcnews: The visitors’ entrances to the National Institutes of Health are blocked off with traffic cones. The usually teeming campus, spread over rolling green hills in the Washington, D.C. suburb of Bethesda, Md., is quiet. The patients inside aren’t so quiet, however. Justin Smith and his daughter McKenna are both furious at Congress. “They need to stop acting like babies,” says McKenna, who turns 13 on Friday.

Shutdown Realities At FDA: No New Submission Reviews, And More

Shutdown Realities At FDA: No New Submission Reviews, And More-thegraysheet:  Out-of-office email responses may be the most some in industry can expect from FDA during the ongoing partial government shutdown. In particular, new PMA and 510(k) submissions, and anything else tied to a user fee payment, are not being reviewed by FDA as of Oct. 1 as a result of the impasse in Congress on funding government agencies for the start of fiscal year 2014.

Obama’s price of victory

Obama’s price of victory-politico: Twenty years ago, when he was trying to convince Bill and Hillary Clinton that universal health care was a politically unrealistic goal, the late Sen. Daniel Patrick Moynihan repeated one insistent warning: Sweeping, historic laws don’t pass barely. “They pass 70-30,’’ he said, “or they fail.”

Wonkbook: This is what the Republicans were afraid of

Wonkbook: This is what the Republicans were afraid of-washingtonpost: The juxtaposition of Tuesday's two top stories was extraordinary. The top story all day was that Republicans had shut down the federal government because President Obama wouldn't defund or delay the Affordable Care Act. The other major story was that the government's servers were crashing because so many people were trying to see if they could get insurance through Obamacare.

How Do You Design a Hospital That Can Foster Great Ideas?

How Do You Design a Hospital That Can Foster Great Ideas?-wired: It might sound like a pretty basic idea: Get researchers and physicians in the same building and increase productivity and innovation, but it’s actually far less common than you might think. Most of the time, medical centers and research facilities are kept separate, often in completely different buildings that require a car ride or at least a long walk to get to. Even traditional hospitals are full of silos, with cardiologists on one floor, radiologists on another and neurologists in their own separate area.

Device Tax On The Table In Negotiations To End Shutdown – Sen. Durbin

Device Tax On The Table In Negotiations To End Shutdown – Sen. Durbin-thegraysheet: A repeal of the medical device tax could be on the table as a compromise issue for resolving a stalemate on government funding legislation that caused the government to enter a partial shutdown Oct. 1, according to high-ranking Democratic Sen. Dick Durbin. When asked on CNN Oct. 1 whether there was any component of the Affordable Care Act that the Senate could consider voting on as part of a short-term funding continuing resolution bill that needs to pass to re-open the government, Durbin singled out the device tax.