Chinese regulators to launch simplified registration renewal process in 2014

Chinese regulators to launch simplified registration renewal process in 2014-massdevice: The China Food and Drug Administration (CFDA) will implement a simplified certification renewal process January 1, 2014 for medical devices. With the exception of devices with major changes, manufacturers seeking to renew their medical device registrations in China will face fewer documentation requirements and potentially faster re-certifications.

Senate Approves Budget Bill, Giving Lawmakers Less Than A Month To Fund FDA, Other Agencies

Senate Approves Budget Bill, Giving Lawmakers Less Than A Month To Fund FDA, Other Agencies-thegraysheet: The Senate in a 64-36 vote approved a budget framework Dec. 18 and President Obama is expected to quickly sign the measure. The agreement, struck by Sen. Patty Murray, D-Wash., and Rep. Paul Ryan, R-Wis., earlier this month, would give Senate and House appropriators less than a month – until the current continuing resolution ends Jan. 15 – to advance either independent funding bills for federal agencies, including FDA, or to wrap all 12 appropriations bills into one omnibus spending package for FY 2014. The House already approved the bill on a 332-94 vote Dec. 12. 

President Obama turns left

President Obama turns left-politico: President Barack Obama wants to sound like a different kind of Democrat. He’s connecting to progressive populism with an aggressive, spending-oriented, activist government approach to the economy personified by Elizabeth Warren and Bill de Blasio. Obama’s already backed raising the minimum wage, the start of what White House officials say will be a 2014 domestic agenda — including his State of the Union address and budget — that centers around income inequality and what the government is doing to increase economic mobility.

W&M Unanimously Passes SGR Repeal Bill Following Last-Minute Tweak

W&M Unanimously Passes SGR Repeal Bill Following Last-Minute Tweak-insidehealthpolicy: The House Ways & Means Committee on Thursday (Dec. 12) unanimously approved physician payment reform legislation after Chair Dave Camp (R-MI) revised the bill a day earlier to avert a revolt from surgeons by including a 0.5 percent pay increase. The Senate Finance Committee, which worked jointly with W&M on SGR-repeal legislation, marked up a version without the 0.5 percent pay increase Thursday, but had to work through dozens of amendments prior to a final vote.

Budget Accord Should Increase FDA Funding, Free Up User Fees

Budget Accord Should Increase FDA Funding, Free Up User Fees-thegraysheet:  The two-year budget deal up for consideration in Congress will have a positive financial impact on FDA, and incorporates non-binding language favoring device tax repeal. House and Senate Joint Budget Committee leaders Sen. Patty Murray, D-Wash., and Paul Ryan, R-Wis., unveiled the agreement Dec. 10. The House voted to approve the measure Dec. 12 on a vote of 332-94, and the Senate is expected to take it up the week of Dec. 16.

Hospital lobby dismayed by budget deal, SGR fix

Hospital lobby dismayed by budget deal, SGR fix-politico: The nation’s hospital lobby is reacting strongly and angrily to the new congressional budget deal, saying that facilities will remain on “an endless merry-go-round of making ends meet” because of how the two-year agreement excludes them from sequester relief. The deal not only doesn’t shelter hospitals from the cuts they absorbed from the sequester but extends those reductions to 2023, beyond the original 10-year window in the Budget Control Act.

W&M SGR Manager's Amendment To Hike Pay 0.5% In Response To Surgeons

W&M SGR Manager's Amendment To Hike Pay 0.5% In Response To Surgeons-insidehealthpolicy: Responding to demands of surgeons, House Ways & Means Chair Dave Camp (R-MI) is going to include a 0.5 percent pay increase, each year, for three years, in the manager's amendment for Medicare physician pay reform that his committee is marking up Thursday (Dec. 12), according to several sources following the legislation. The pay hike was the top demand from surgeons who surprised lawmakers on Tuesday (Dec. 10) by opposing SGR legislation by the W&M and Senate Finance committees in favor of the bill passed by the House Energy & Commerce, which includes the pay increase. The surgeons on Wednesday withdrew their opposition in light of the base-pay hike, according to a letter obtained by Inside Health Policy.

Independent Assessment Of CDRH Calls For Staff Training, Review Process Improvements

Independent Assessment Of CDRH Calls For Staff Training, Review Process Improvements-thegraysheet: An independent assessment contracted by CDRH says the center needs to improve the consistency of its device review process and strengthen its training programs. CDRH published the priority recommendations (PDF) from Booz Allen Hamilton assessing the device center’s review process for device submissions. The Dec. 11 document includes four priority recommendations from Booz Allen, which was contracted by FDA to conduct a two-phase assessment of FDA’s device review program as part of the third medical device user fee agreement (MDUFA III) between industry and FDA, enacted in October 2012.

Dishman: Mobile health needs culture innovation, not just tech innovation

Dishman: Mobile health needs culture innovation, not just tech innovation-mobihealhnews: “Can an early adopter like me, who knows the key CEOs at the key companies, who makes money, who speaks English, who has all the advantages I do, could I pull off making the hospital obsolete?” he said. “Well, I’m going to give you some tough love from a very frustrated patient.”

Finance, W&M SGR Bills Start Diverging Prior To Markups

Finance, W&M SGR Bills Start Diverging Prior To Markups-insidehealthpolicy: Medicare physician payment reform proposals released Tuesday (Dec. 10) by the Senate Finance and House Ways & Means committees are beginning to diverge a bit: the Finance bill includes other Medicare payment extenders, and Ways & Means' draft incorporates a medical liability measure aimed at keeping the GOP Doctors' Caucus on board, lobbyists say.

FDA To Launch Voluntary Compliance Improvement Pilot This Month

FDA To Launch Voluntary Compliance Improvement Pilot This Month-thegraysheet: The CDRH Office of Compliance will launch a pilot program this month to allow firms with a history of manufacturing quality control problems to identify and self-correct their deficiencies. The official launch of the Voluntary Compliance Improvement Pilot will be “as early as later this week,” Office of Compliance Director Steven Silverman said Dec. 10 at the Food and Drug Law Institute’s Enforcement, Litigation and Compliance Conference in Washington, D.C. “But if not this week, I would say that its announcement is imminent,” Silverman said.

Why the timing is right for a budget deal

Why the timing is right for a budget deal-politico: John Boehner and Barack Obama failed. Harry Reid, Boehner and Mitch McConnell didn’t fare much better. Eric Cantor and Joe Biden barely got started. But with the year winding to a close, Sen. Patty Murray (D-Wash.) and Rep. Paul Ryan (R-Wis.) are nearing a modest, yet important, budget deal that senior aides say could be rolled out as soon as Tuesday and voted on later this week.

Dick Cheney: The medtech tax attacks an industry that saved my life

Dick Cheney: The medtech tax attacks an industry that saved my life-massdevice: MASSDEVICE ON CALL — Former Vice President Dick Cheney continued to publicly criticize the medtech tax while on tour for his new book, "Heart: An American Medical Odyssey." Cheney told the hosts of "Fox & Friends" this week that the medtech tax hampers innovation in medical technologies, and that he has relied on the industry time and again to save his life.

CMS Lessens Lab Test Cuts, Finalizes Revaluation Proposal In Physician Fee Schedule

CMS Lessens Lab Test Cuts, Finalizes Revaluation Proposal In Physician Fee Schedule-thegraysheet: Diagnostic laboratories and test makers can breathe easier in the near-term following CMS’ decision to scale back planned 2014 payment cuts to independent laboratories in the latest physician fee schedule. But the agency is moving forward with a longer-term wholesale review and planned revision of laboratory payments that is likely to keep the diagnostics community anxious.

Lawmakers Plan 30-90 Day SGR Patch As Bridge To Putting SGR Repeal In Deficit Deal In Spring

Lawmakers Plan 30-90 Day SGR Patch As Bridge To Putting SGR Repeal In Deficit Deal In Spring-insidehealthpolicy: House Energy & Commerce Chair Fred Upton (R-MI) said at a Wednesday morning meeting that Congress is working on a short-term physician payment patch that could allow Congress to include permanent payment reform in a debt ceiling deal in the spring, according to an attendee of the breakfast meeting sponsored by Villanova Center for Marketing and Public Policy Research. The debt ceiling comes up in February, but Upton was likely expressing the more realistic expectation that Congress will push back that deadline to work out a debt ceiling deal, the source said. Upton also said he wants to bring his SGR repeal bill back up in the spring, but lobbyists said the alternative proposal by House Ways & Means and Senate Finance is viewed as the lead legislation.

CMS Proposes Removing 10 Outdated National Coverage Policies

CMS Proposes Removing 10 Outdated National Coverage Policies-thegraysheet: CMS has proposed removing 10 national coverage determinations as part of an expedited removal process to review long-standing NCDs and remove those that are either no longer clinically pertinent or used infrequently. The Medicare agency posted the list Nov. 27, the first application of its expedited removal process announced in August. Included among the NCDs are policies for laser procedures, a carotid sinus nerve stimulator and electroencephalographic (EEG) monitoring during open-heart surgery. 

Finance, W&M To Meet Doctor Lobbyists Dec. 4 To Discuss SGR Bill Changes

Finance, W&M To Meet Doctor Lobbyists Dec. 4 To Discuss SGR Bill Changes-insidehealthpolicy: Staff from the Senate Finance and House Ways & Means committees plan to meet with physician lobbyists Wednesday (Dec. 4) to explain changes to SGR repeal legislation as the two committees prepare to mark up that bill next week, physician lobbyists said. Finance is scheduled to mark up a bill to replace the Medicare Sustainable Growth Rate physician payment formula on Dec. 12, and although Ways & Means has not made an announcement, sources say that committee hopes to hold a mark up the end of next week.

CMS Will Switch To Centralized Coverage Review Of IDE Trials, But Not Until 2015

CMS Will Switch To Centralized Coverage Review Of IDE Trials, But Not Until 2015-thegraysheet: CMS will go forward with its recent proposal to centralize the review of investigational device exemption study coverage, but will delay implementation of the new approach until Jan. 1, 2015. The agency explained the new process in its 2014 physician fee schedule final rule (PDF), released Nov. 27. The rule also creates a new set of criteria that IDE studies must be met to gain Medicare coverage.

MedMal Bill Could Be Among Flood Of Amendments At Finance SGR Mark Up Next Week

MedMal Bill Could Be Among Flood Of Amendments At Finance SGR Mark Up Next Week-insidehealthpolicy: Physicians could not be sued for malpractice based solely on not following federal guidelines, such as performance measures used in bonus programs, according to a  bipartisan bill that a doctor lobbyist expects to be offered as an amendment during next week's Senate Finance Committee markup of legislation to replace the Medicare Sustainable Growth Rate payment formula. There is a lot of pent-up demand for Medicare legislation because Finance hasn't marked up a Medicare bill since President Obama's health care law in 2009 and annual SGR patches for years haven't included Medicare policy changes so there could be a flood of amendments at the Dec. 12 SGR markup, physician lobbyists and congressional staff say.

Update on US FDA Unique Device Identification Submission System

Update on US FDA Unique Device Identification Submission System-massdevice: Manufacturers with US medical device market authorization are required to submit device identification data into a Global Unique Device Identification Database (GUDID) managed by the FDA. Firms now have two options for submitting information to the GUDID: a GUDID Web Interface that requires users to set up GUDID accounts, and an HL7 SPL option for submitting device information via xml file one record at a time.

Looming SGR Pay Cut Now At 20%; Primary Docs Get New Billing Codes

Looming SGR Pay Cut Now At 20%; Primary Docs Get New Billing Codes-insidehealthpolicy: CMS is lowering the looming Medicare pay cut for physicians from 24.4 percent to 20.1 percent, according to the 2014 final Physician Fee Schedule rule. The rule also institutes, starting in 2015, billing codes that pay primary-care doctors for managing chronically ill patients, and the regulation revalues some 200 codes. However, those revalued codes may change, and CMS decided against adjusting relative values to cap physician practice expense pay for procedures furnished in a non-facility setting at the rate for the service furnished in ambulatory surgical centers or hospital outpatient departments.

Early Registry Outcomes Suggest TAVR Roll-Out Has Been Successful So Far

Early Registry Outcomes Suggest TAVR Roll-Out Has Been Successful So Far-thegraysheet: The carefully controlled roll-out of transcatheter aortic valve replacement in the U.S. appears to be working as intended so far. The first report of national postmarket TAVR registry data shows the procedural success rates and early complication rates are no worse than they were in the randomized trials or registries in other countries.

PCORI To Solicit More Head-To-Head Comparative Studies

PCORI To Solicit More Head-To-Head Comparative Studies-thegraysheet: The Patient-Centered Outcomes Research Institute is taking action to boost the number of head-to-head comparative effectiveness trials it funds after a review of applications selected for funding during its first three cycles found a relatively low number of direct head-to-head comparisons. “It’s pretty clear that PCORI needs to do something to increase in its portfolio the numbers of genuine primary comparative evaluations of prevention, diagnosis and treatment management options,” PCORI Executive Director Joe Selby said during the institute’s Nov. 18 board of governors meeting in Atlanta. So he described a “very early proposal for … a set of actions to address the relative lack of primary head-to-head comparative studies.”