U.S. says results encouraging for healthcare delivery reforms

U.S. says results encouraging for healthcare delivery reforms-reuters: (Reuters) - The Obama administration on Thursday reported what it called encouraging results from efforts to reduce healthcare costs and improve the quality of care for more than 5 million Medicare beneficiaries under Obamacare. As part of President Barack Obama's healthcare reform law, the efforts center around more than 360 accountable care organizations (ACOs), which are networks of doctors, hospitals and other providers specially organized to help move Medicare away from traditional fee-for-service medicine.

Is Sen Majority Leader Reid open to medtech tax repeal?

Is Sen Majority Leader Reid open to medtech tax repeal?-massdevice: Senate Majority Leader Harry Reid (D-Nev.) told reporters this week that he's looking for a few good proposals to alter the Affordable Care Act, giving fellow Senate Democrats a chance to advance bills that may win them some favor during an mid-term elections.

Pay and Practice: Limited Results on ACOs From Medicare

Pay and Practice: Limited Results on ACOs From Medicare-medpagetoday: WASHINGTON -- The Medicare program has released the initial, top-line results for some of its Shared Savings Program Accountable Care Organizations (ACOs), but don't hold your breath looking for specific details or greater meaning.

For 2016, Hillary Clinton has commanding lead over Democrats, GOP race wide open

For 2016, Hillary Clinton has commanding lead over Democrats, GOP race wide open-washingtonpost: Hillary Rodham Clinton holds a commanding 6 to 1 lead over other Democrats heading into the 2016 presidential campaign, while the Republican field is deeply divided with no clear front-runner, according to a new Washington Post-ABC News poll. Clinton trounces her potential primary rivals with 73 percent of Democrats and Democratic-leaning independents, reinforcing a narrative of inevitability around her nomination if she runs. Vice President Biden is second with 12 percent, and Sen. Elizabeth Warren (Mass.) is third with 8 percent.

Washington Roundup: Consultant says UK still a stingy market, NICE an EU bellwether

Washington Roundup: Consultant says UK still a stingy market, NICE an EU bellwether-medicaldevicedaily: Device makers know all too well that obtaining a CE mark is no guarantor of access to European markets, which are at least as tightly governed by payers as by regulatory entities. There are several reasons to approach the UK first, but at least one consultant believes industry might do well to approach other EU nations first. This is in part because reimbursement is very tight in the UK, but also because the authorities in the UK are stubborn about coverage, and their decisions serve as something of an informal standard for coverage decisions in other nations.

Support Grows For Delaying Two-Midnights Policy In SGR Bill

Support Grows For Delaying Two-Midnights Policy In SGR Bill-insidehealthpolicy: Rep. Jim Gerlach's (R-PA) office is drumming up support for a bill that would delay by an additional six months CMS' two-midnights policy and has heard that Ways & Means staff may include the measure in physician-payment reform legislation. House and Senate committees are working through the differences in their respective Sustainable Growth Rate replacement bills and are searching for payment offsets. Including the Gerlach bill in the SGR package is one of the American Hospital Association's biggest priorities. An industry source closely tracking the issue also said Ways & Means has been supportive of the delay, but others say the measure's future remains unclear.

Device Innovation Consortium Plans To Finish Patient-Centered Project This Year

Device Innovation Consortium Plans To Finish Patient-Centered Project This Year-thegraysheet: The Medical Device Innovation Consortium expects to complete its patient-centered benefit-risk assessment project, one of its three priority projects this year, and continue to move forward with its other projects intended to help advance medical device regulatory science in the pre-competitive space.

State of the Union: What he said, what he meant

State of the Union: What he said, what he meant-politico: For a State of the Union speech in an election year, President Barack Obama didn't sound like he was offering too much red meat for his Democratic base. But what looked like a speech aimed at showing he was more interested in policy than politics also included subtle election-year messages and clear warnings that he’s ready to move on from a dismal 2013. The GOP can do its part, Obama said, or get out of the way.

2014 Dems plot Obamacare strategy

2014 Dems plot Obamacare strategy-politico: One of President Barack Obama’s rowdiest standing ovations Tuesday night came when he demanded Republicans drop their endless crusade to repeal his signature health care law. But there’s a more critical bloc of lawmakers he needs to implement Obamacare: vulnerable Democratic senators facing reelection in 2014.

Unwinding in 2014: Analysts bullish on medtech's E.U. prospects

Unwinding in 2014: Analysts bullish on medtech's E.U. prospects-massdevice: The year ahead is looking to be an easier one for medical device companies navigating the European landscape, according to analysts with J.P. Morgan's Europe Equity Research group.

Senators unveil 'repeal and replace' plan

Senators unveil 'repeal and replace' plan-politico: Three senior Senate Republicans on Monday released a proposal to repeal and replace Obamacare, the most serious policy alternative in the Senate since the president’s health law passed nearly four years ago. Sens. Orrin Hatch of Utah, Tom Coburn of Oklahoma and Richard Burr of North Carolina released a legislative outline that would give tax credits to people who aren’t employed at a large company, allow states to establish high-risk pools and dramatically reshape the nation’s Medicaid program, all paid for by capping the tax break for employer health plans.

State of the Union 2014: Obama to take ‘optimistic’ message on the road

State of the Union 2014: Obama to take ‘optimistic’ message on the road-politico: President Barack Obama will deliver an “optimistic” State of the Union address Tuesday prodding Congress to address economic mobility and income inequality — or risk an end-run by the White House. In an email to supporters Saturday, senior White House adviser Dan Pfeiffer wrote that Obama “will lay out a set of real, concrete, practical proposals to grow the economy, strengthen the middle class, and empower all who hope to join it.”

Doctors cut from Medicare Advantage networks struggle with what to tell patients

Doctors cut from Medicare Advantage networks struggle with what to tell patients-washingtonpost: Thousands of primary-care doctors and specialists across the country have been terminated from privately run Medicare Advantage plans, sparking a battle between doctors who say patient care is being threatened and insurers that insist they have to reduce costs and streamline their operations.

Report: FDA looks for more women in medtech trials

Report: FDA looks for more women in medtech trials-massdevice: Nearly half of the premarket approvals and humanitarian device exemptions handed out since 1991 have included post-approval approval requirements, and sex-based data is available for more than 90% of them, according to the study authors. The reports show that women frequently make up less than half of the patients population in cardiovascular, orthopedic, and renal/urologic studies.

Some predictions on how Medicare will release physician payment data

Some predictions on how Medicare will release physician payment data-massdevice: The federal government's announcement last week that it would begin releasing data on physician payments in the Medicare program seems to have ticked off both supporters and opponents of broader transparency in medicine.

Republicans seek own policy cure to replace Obamacare

Republicans seek own policy cure to replace Obamacare-reuters: (Reuters) - Top Republicans are saying they can no longer just be the party of "No" on Obamacare: They need to come up with an alternative healthcare policy. While many Americans are skeptical of President Barack Obama's healthcare overhaul, they also tell lawmakers they worry about keeping their costs from getting out of control. For those voters, a party that offers a platform to repeal the 2010 law without anything to replace it may not be very attractive.

IOM Plans Study To Facilitate Clinical Trial Data Sharing

IOM Plans Study To Facilitate Clinical Trial Data Sharing-thegraysheet: Clinical trials investigating devices, drugs, procedures and other interventions generate vast amounts of data. A subset of that data may be published in a journal, and more of it will sit behind closed doors at FDA or other government agencies and with the trial sponsor, but much of it is not available to other researchers or the public. There is a strong push for more data transparency in the health care community, although industry tends to be cautious about the idea, citing concerns about the release of trade secrets and the potential misuse of data.

Sen. Hatch slams the 'stupid' medtech tax

Sen. Hatch slams the 'stupid' medtech tax-massdevice: MASSDEVICE ON CALL — Sen. Orrin Hatch (R-Utah) had some harsh words for the medical device tax and its role in helping pay for the Affordable Care Act, calling the levy little more than a thin attempt to conceal the deep costs of healthcare reform.

Even small ball too much for Congress

Even small ball too much for Congress-politico: Everybody knows that Congress can’t do anything big any more — but it turns out Capitol Hill is equally hapless about getting the small stuff done as well. All the dysfunctional partisan gridlock keeping the House and Senate worlds apart on the transcendent issues of the day also means little progress on the no-brainers, like technical corrections and minor fixes to Obamacare and the Dodd-Frank Wall Street reform law. Revamping the nation’s energy policies with low-hanging fruit proposals championed by both Democratic and GOP lawmakers are stuck, too.

Medtech tax repeal among Sen. Coats' top priorities

Medtech tax repeal among Sen. Coats' top priorities-massdevice: MASSDEVICE ON CALL — Sen. Dan Coats (R-Ind.) called on fellow lawmakers to repeal the medical device tax, saying that striking the levy is among his top legislative priorities for the year.

Many hospitalized older people need decision help

Many hospitalized older people need decision help-reuters: (Reuters Health)- When the time comes for making critical medical decisions while in the hospital, a new study says older people often rely on family members or other surrogates to make those calls. Researchers found that about half of the older patients they tracked needed help making decisions within two days of being admitted to the hospital.

MedPAC Considers Factoring Sequester Into Pay Recommendations

MedPAC Considers Factoring Sequester Into Pay Recommendations-insidehealthpolicy: Congressional Medicare advisers are considering factoring sequestration into their payment recommendations in response to Congress' decision to extend sequestration another two years in the Bipartisan Budget Act. Providers, such as hospitals, say they want the Medicare Payment Advisory Commission to incorporate the sequesters pay cuts into its payment recommendations and profit-margin projections because excluding sequestration gives an inaccurate picture of providers' financial status.

CMS Will Consider Disclosing Physician Pay Information Case-By-Case

CMS Will Consider Disclosing Physician Pay Information Case-By-Case-thegraysheet: The new policy, scheduled to take effect March 18, follows on the heels of efforts made by CMS last year to make more data available to the public. In May, CMS released information on the average charges for the 100 most common inpatient services at more than 3,000 hospitals nationwide. (See "Minimal Correlation To Device Costs In CMS-Released Hospital Charge Data" — "The Gray Sheet," May 13, 2013.) And in June, CMS released average charges for 30 selected outpatient procedures.

Revised Rules For Japan’s Medical Devices Could Mean Speedier Time To Market

Revised Rules For Japan’s Medical Devices Could Mean Speedier Time To Market-thegraysheet: Processing medical devices and software for market entry in Japan should speed up noticeably in 2014 due to the Japanese government’s revisions to the pharmaceutical affairs law. Rules that were previously combined for both drugs and medical devices were separated under the revisions issued by the Ministry of Health, Labor and Welfare in 2013.

Under Pressure From Congress, VA Aims To Buy More Implants In Bulk

Under Pressure From Congress, VA Aims To Buy More Implants In Bulk-thegraysheet:  An investigation into the U.S. Department of Veterans Affairs management of surgical implants by the Government Accountability Office found that the VA was not following its own bulk purchase requirements, lacked a system for tracking patients with the implanted devices and may have allowed company vendors to directly operate on veterans in some instances – to the frustration of Representatives on the House Committee of Veterans’ Affairs.

Senate approves $1.1 trillion spending bill

Senate approves $1.1 trillion spending bill-politico: A landmark $1.1 trillion spending bill cleared Congress Thursday evening after conservative resistance collapsed in the Senate and tea party favorite Ted Cruz dropped his insistence on a vote on funding for President Barack Obama’s health care plan. On back-to-back 72-26 roll calls, senators voted to cut off debate and then quickly adopted the bill, which keeps the government funded through September.

Wyden offers bipartisan chronic disease bill

Wyden offers bipartisan chronic disease bill-politico: The voluntary program outlined by Sen. Ron Wyden (D-Ore.) would allow Medicare providers to operate “Better Care Plans” or “Better Care Practices.” They would receive new risk adjustments, capitated payments and be rewarded for better outcomes. It would lift federal prohibitions on providers from reaching out to the sickest patients to provide care. And providers could also use incentives to motivate patients.

14 health care innovation predictions for 2014

14 health care innovation predictions for 2014-massdevice: 2013 saw an accelerated crumbling of borders and boundaries in health care, fueled by technological and scientific advances. Boundaries between high-tech Western medicine and global health practices have begun blurring in interesting ways, as are those between home and hospital, patient and doctor and even a patient's own body and the treatment used for her disease.

FDA Draft Guidance Provides Definitions, Recommendations For Custom Devices

FDA Draft Guidance Provides Definitions, Recommendations For Custom Devices-thegraysheet: A new FDA draft guidance (PDF) on custom device exemptions provides industry with definitions for custom devices, explains how FDA plans to interpret regulatory language that limits production to “five units per year of a particular device type,” and provides recommendations for information to be included in annual reports. The Jan. 13 guidance was mandated by the FDA Safety and Innovation Act of 2012, which included a new provision amending an existing custom device exemption. Manufacturers rely on the exemption in limited cases to create or modify a version of a device to meet a doctor’s or a patient’s specific needs without submitting a PMA to FDA.

AdvaMed lauds user fee return, new funding for FDA

AdvaMed lauds user fee return, new funding for FDA-massdevice: MASSDEVICE ON CALL — Medtech industry lobbying group AdvaMed offered high praise for the federal government's 2014 omnibus appropriations legislation, which restored important funding for the FDA. The bill returned to the agency about $85 million in collected user fees that had been locked away due to the federal sequester, funds that medical device and drug companies pay for applications for FDA review.

Congress Eyes LIS Copay Policy As SGR Offset, But Safeguards Lower Savings

Congress Eyes LIS Copay Policy As SGR Offset, But Safeguards Lower Savings-insidehealthpolicy: Lawmakers in both parties are seriously considering an SGR offset that would let plans steer low-income subsidy beneficiaries toward generic drugs by raising copays for brands and eliminating copays for generics, pharmaceutical and patient lobbyists say, and the Congressional Budget Office is scoring different approaches. But safeguards considered by lawmakers to protect beneficiary access could significantly decrease the savings, lobbyists say -- CBO recently estimated the copay policy would save $29 billion over 10 years and is again reviewing the proposal now that lawmakers are considering safeguards.

FDA Gets $91 Million Boost In FY 2014 Appropriations Agreement; Sequestered FY 2013 User Fees Would Be Released

FDA Gets $91 Million Boost In FY 2014 Appropriations Agreement; Sequestered FY 2013 User Fees Would Be Released-thegraysheet: FDA would get $2.55 billion in congressionally appropriated funds for fiscal year 2014, an increase of $91 million above FY 2013 enacted levels under a bipartisan appropriations agreement reached by Senate and House appropriators late Jan. 13. The bill also includes $85 million to restore device, drug and other industry user fees collected in FY 2013 but withheld from FDA by last year’s sequestration. 

House expected to vote Tuesday on 3-day CR

House expected to vote Tuesday on 3-day CR-politico: With an agreement in hand, House-Senate negotiators prepared to roll out a $1.1 trillion spending bill Monday night — a giant package that fills in the blanks of the December budget agreement and promises to restore some order to government funding over the next year. To avert any threat of a shutdown, the House first will take up Tuesday a three-day extension of the current stopgap continuing resolution due to expire Wednesday. The leadership expects to move quickly next to the larger omnibus bill, and the hope is to send it on to President Barack Obama before the new deadline of Saturday, Jan. 18.

$1.1 trillion spending bill unveiled

$1.1 trillion spending bill unveiled-politico: House-Senate negotiators rolled out a $1.1 trillion spending bill Monday night — a giant package that fills in the blanks of the December budget agreement and promises to restore some order to government funding over the next year. Under pressure from Republicans, the measure keeps a tight rein on new funding for Wall Street regulators and effectively freezes appropriations for President Barack Obama’s health care program at the reduced, post-sequester level.

FDA Distinguishes Pre-Market Expectations For Professional Vs. Home Glucose Meters

FDA Distinguishes Pre-Market Expectations For Professional Vs. Home Glucose Meters-thegraysheet:  FDA issued two draft guidance documents Jan. 6 providing recommendations that seek to distinguish pre-market submission requirements for blood glucose monitors used in professional health care settings versus over-the-counter self-monitoring by lay-persons. “Historically, FDA has not recommended different types of information in pre-market submissions (510(k)s) for blood glucose monitoring systems used by medical professionals as compared to [over-the-counter] devices intended for use by lay users,” the agency said in a federal register notice accompanying the documents.

CDRH’s 2014 Enforcement Strategy – Less Talk, More Action, Says Steven Silverman

CDRH’s 2014 Enforcement Strategy – Less Talk, More Action, Says Steven Silverman-thegrahsheet: Steven Silverman, who directs CDRH’s Office of Compliance, says this year he wants to translate his recent focus on better collaboration with manufacturers into more tangible actions that improve device design and quality. The center recently unveiled several pilot programs, set to get off the ground this year, with that goal in mind. The Voluntary Compliance Improvement Pilot will give manufacturers at risk of enforcement actions due to regulatory violations an opportunity to identify and self-correct the violations

Congress Grapples With Primary Care Pay

Congress Grapples With Primary Care Pay-medpagetoday: WASHINGTON -- Some Democratic lawmakers have expressed interest in extending the pay increases for primary care physicians in Medicare and Medicaid that are temporarily in effect under the Affordable Care Act (ACA). The measure to continue the pay increases -- which could come in legislation that repeals Medicare's sustainable growth rate (SGR) payment formula -- faces a tough battle as a budget-conscious Congress works to keep an SGR repeal price tag low

Medicare Appeals Office To Hold Meeting On Ways To Reduce Backlog

Medicare Appeals Office To Hold Meeting On Ways To Reduce Backlog-insidehealthpolicy: 

The Office of Medicare Hearings and Appeals will hold a meeting next month for those appealing Medicare claims to discuss various agency attempts to handle the appeals backlog at the Administrative Law Judge, or third level, of the appeals system, the office announced in the Federal Register Friday (Jan. 3). The appeals office says it is taking steps -- including prioritizing beneficiary appeals -- to "mitigate the workload increase" and is planning more activities going forward to make the system more efficient.

Skin-like material can 'sense' if surgeons get off track

Skin-like material can 'sense' if surgeons get off track-massdevice: When surgeons perform image-guided minimally invasive procedures, some aspects of visualization and image quality are typically compromised as compared with open surgeries in which the physician can peer into the body. However, a new pressure-sensing material, placed over an endoscope, may someday provide surgeons with additional guidance and protect healthy tissue during these procedures.

U.S. FDA provides 510(k) communication timeline

U.S. FDA provides 510(k) communication timeline-massdevice: The US Food and Drug Administration recently added a new timeline to its 510(k) premarket notification webpage that summarizes typicalcommunications between agency reviewers and medical device applicants between submission and final clearance.

Wyden: Price transparency is a top focus in SGR repeal

Wyden: Price transparency is a top focus in SGR repeal-politico: The SGR repeal bill passed the committee in December, just days before news broke that Chairman Max Baucus will become ambassador to China. Baucus told POLITICO on Monday that he’d like to make progress on the bill before he departs — possibly as early as next month — but it would be all but impossible to get the legislation through the Senate that quickly.

IMDRF targets uniform standards for medical device auditors

IMDRF targets uniform standards for medical device auditors-massdevice: The International Medical Device Regulators Forum (IMDRF) has published new recommended requirements for recognizing device company auditors ahead of an international auditing program pilot launching this year in the US, Canada, Brazil and Australia. Separately, the IMDRF has issued final documents on related topics including auditor training requirements, Unique Device Identification (UDI) and software as a medical device.

Health Care Spending Growth Stays Slow, CMS Says

Health Care Spending Growth Stays Slow, CMS Says-thegraysheet: \Historically low growth rates in U.S. health care spending continued in 2012, CMS announced Jan. 6, citing the recent economic recession as the major contributing factor. The growth rate in 2012, for which the most recent data is available, remained at 3.7 percent, consistent with the 2011 rate, CMS stated in its annual report on health care spending, which will be published in the January issue of the journal Health Affairs.

Budget battle nears finish line

Budget battle nears finish line-politico: House-Senate negotiators are slated to meet Monday in hopes of narrowing their last differences over a $1 trillion-plus omnibus spending bill that attempts to fill in the blanks after December’s budget deal and avoid another shutdown next week. If last month’s agreement said how much Congress can spend this year, the giant appropriations measure now spells out where the dollars will go. Hundreds of pages long, it literally touches every corner of the government. But its very scope also invites conflict over everything from Wall Street’s banks to Appalachia’s coal industry — championed by House Appropriations Committee Chairman Hal Rogers (R-Ky.).

FDA Budget, Physician Payments On Tap For Congress In The New Year

FDA Budget, Physician Payments On Tap For Congress In The New Year-thegraysheet: As 2014 begins, Congress must get to work right away on two pending pieces of legislation with important implications the device industry: appropriations for FDA, and a permanent repeal and replacement of the Medicare sustainable growth rate formula for Medicare physician payments. Sen. Barbara Mikulski, D-Md., who heads the Senate Appropriations Committee, recently signaled her intent to get to work immediately on an omnibus appropriations bill based on the topline funding ceiling set in a budget agreement passed by Congress last month, and signed by the President Dec. 26.