Is the FDA Ready For 21st Century Cures?

Is the FDA Ready For 21st Century Cures?-morningconsult: Legislation to expedite the approval of new drugs passed its first hurdle last week, but Food and Drug Administration officials say the funds granted by the overhaul effort aren’t enough. The bill, also known as 21st Century Cures, will place new pressures on an agency that says it’s responsible for regulating products that account for as much as 25 percent of U.S. consumer spending.

Top Dem: Trade deal could restrict access to cheaper medicines

Top Dem: Trade deal could restrict access to cheaper medicines-thehill: Rep. Sandy Levin (Mich.), the top Democrat on the Ways and Means Committee, says a new trade deal could be a “major step backwards” on access to affordable medicines. In an op-ed Thursday, Levin raised concerns that the 12-country Trans-Pacific Partnership (TPP) trade deal, which the U.S. is negotiating, will curtail access to generic drugs.

GOP Split on Possible Health-Law Fixes

GOP Split on Possible Health-Law Fixes-wallstreetjournal: A month before the Supreme Court is expected to rule on a key component of the Affordable Care Act, congressional Republicans are split over their strategy for handling the possible fallout.

Puerto Rico's Debt Crisis Is Big Business for Washington Lobbyists

Puerto Rico's Debt Crisis Is Big Business for Washington Lobbyists-bloomberg: That ugly B word, bailout, has come to dominate debate in Washington about Puerto Rico’s debt crisis. One side argues that passing a bill allowing Puerto Rican government agencies to restructure their debts will stave off an eventual bailout of the whole island. The other side says that’s all wrong: The very act of approving the legislation will constitute a bailout.

F.B.I. Investigates Whether Harm From Surgical Power Tool Was Ignored

F.B.I. Investigates Whether Harm From Surgical Power Tool Was Ignored-newyorktimes: The FBI is investigating whether “medical device makers, doctors and hospitals” failed to report deficiencies with a power tool used during gynecological surgery.

The New York Times blows a hole in the case against Obamacare

The New York Times blows a hole in the case against Obamacare-vox: There are basically two versions of the looming Supreme Court case against Obamacare. One of them makes sense but doesn't pose enough of a threat to Obamacare to satisfy Republicans. The other poses a real threat to Obamacare, but it's never made much sense — and the New York Times just blew a hole right through the middle of it.

Overhead costs exploding under ObamaCare, study finds

Overhead costs exploding under ObamaCare, study finds-thehill: Five years after the passage of ObamaCare, there is one expense that’s still causing sticker shock across the healthcare industry: overhead costs. The administrative costs for healthcare plans are expected to explode by more than a quarter of a trillion dollars over the next decade, according to a new study published by the Health Affairs blog.

The House Is Suing Obama Over an Obamacare Change It Likes

The House Is Suing Obama Over an Obamacare Change It Likes-nationaljournal: The Affordable Care Act is heading back to the courts yet again this week, as the House Republican lawsuit challenging the Obama administration's executive changes to the law will get a hearing Thursday at a federal district court in Washington.

Why you can't blame Obamacare for the crisis in 'underinsurance'

Why you can't blame Obamacare for the crisis in 'underinsurance'-latimes: Thanks to a couple of timely surveys of medical consumers, the focus of the healthcare debate has shifted abruptly from helping the uninsured to how to help the "underinsured." These are the people who have insurance but still face co-pays and deductibles that could break them financially if they had a major medical need. It shouldn't surprise anyone that anti-Obamacare conservatives have seized on the trend, declaring it another flaw in the Affordable Care Act and blaming the act for making it worse. They're wrong, and their own figures prove it.

Trade Votes Play Big in 2016 Politics

Trade Votes Play Big in 2016 Politics-rollcall: Rob Portman isn’t a bomb thrower. But his pitch last week for an amendment cracking down on countries that artificially weaken their currencies threatened to blow up President Barack Obama’s trade agenda, and exposed a deep split in approaches among Republicans who face the voters in 2016.

Updated SOFTWARE Act: Still Too Ambiguous For Industry?

Updated SOFTWARE Act: Still Too Ambiguous For Industry?-thegraysheet: While some industry experts say the updated version of the SOFTWARE Act strikes a tenable balance between industry's need for certainty and FDA's need to ensure patient safety, others argue it does not go far enough to explicitly state what kinds of health IT software the agency will not regulate.

Four Words That Imperil Health Care Law Were All a Mistake, Writers Now Say

Four Words That Imperil Health Care Law Were All a Mistake, Writers Now Say-newyorktimes: The four words at the heart of King v. Burwell create a distinction that the health care law’s drafters say they did not intend to make, the New York Times reports.

On policy, Clinton plays it safe

On policy, Clinton plays it safe-politico: Hillary Clinton’s approach to policy, so far, has been as risk-averse as her media strategy. On the trail, she prefers the safe haven of the controlled roundtable setting, and for the most part avoids taking questions from the press.

Senate Passes Trade Promotion Authority

Senate Passes Trade Promotion Authority-rollcall: The Senate passed President Barack Obama’s Trade Promotion Authority package Friday, sending the precursor to major trade deals with Asia and Europe to the House. The package survived a near-death experience Thursday, with the Senate voting narrowly to cut off a filibuster in an extended vote, and again Friday, when the Senate narrowly rejected a bipartisan currency enforcement amendment that had drawn a veto threat.

TAVR May Be A Good Choice For Even Low-Risk Patients, NOTION Trial Shows

TAVR May Be A Good Choice For Even Low-Risk Patients, NOTION Trial Shows-graysheet: So far, transcatheter aortic valves are only indicated for patients for whom surgery presents high or even intolerable risks. Two-year data from a trial in Scandinavia suggests TAVR could eventually supplant surgical valve replacement in patients at low risk during surgery, but this approach will require more study.

Medical cures bill unanimously passes House panel

Medical cures bill unanimously passes House panel-thehill: The House Energy and Commerce Committee on Thursday unanimously approved a medical cures bill shortly after reaching a bipartisan $13 billion deal to pay for the legislation.

Covered California to cap patient costs for high-priced specialty drugs

Covered California to cap patient costs for high-priced specialty drugs-sacramentobee: Covered California board members voted Thursday to become the first state health care exchange in the nation to impose price caps on high-cost specialty drugs to treat conditions such as hepatitis C and HIV.

Read more here: http://www.sacbee.com/news/local/health-and-medicine/article21624015.html#storylink=cpy

$550 Million FDA Fund Approved In Cures Bill, Paid For With Oil Reserves

$550 Million FDA Fund Approved In Cures Bill, Paid For With Oil Reserves-thegraysheet: A House panel agreed 51-0 to approve 21st Century Cures legislation, including a $550 million, five-year fund to cover some of the FDA mandates in the bill, but not the device reforms. Reform spending would be offset by the sale of eight million barrels of oil from the Strategic Petroleum Reserve.

Energy & Commerce Passes Cures Bill With $13.2B In Offsets

Energy & Commerce Passes Cures Bill With $13.2B In Offsets-insidehealthpolicy: The House Energy and Commerce Committee Thursday morning unanimously passed 21st Century Cures legislation that includes $13.2 billion in offsets cobbled together late Wednesday to help pay for the bill's increased funding for the National Institutes of Health and FDA.

House Energy & Commerce Floats $13 Billion In Offsets For Cures Bill

House Energy & Commerce Floats $13 Billion In Offsets For Cures Bill-insidehealthpolicy: House Energy & Commerce leaders are floating a list of $13 billion in proposed offsets to pay for their 21st Century Cures bill that span from policies affecting the Strategic Petroleum Reserve to Medicare and Medicaid, Inside Health Policy has learned.

Sanchez Stumbles Prompt SoCal Angst

Sanchez Stumbles Prompt SoCal Angst-rollcall: Long shut out of statewide office, Southern California Democrats saw a glimmer of hope last week, when Orange County Rep. Loretta Sanchez announced a bid for the Golden State’s open Senate seat. But a series of stumbles out of the gate has left some of them hesitant about whether they will back her uphill battle against state Attorney General Kamala Harris — with some waiting on Rep. Xavier Becerra, who is still considering jumping into the primary.

Cures Bill Would Mandate Flurry Of Device Guidance Documents

Cures Bill Would Mandate Flurry Of Device Guidance Documents-graysheet: A long list of device-related draft guidances, most due within 12 months of passage, would result from the 21st Century Cures bill that is set for a full House Committee vote May 21.

Hill Democrats Aren't Prepping for Potential 'Policy Armageddon'

Hill Democrats Aren't Prepping for Potential 'Policy Armageddon'-nationaljournal: A month before the Supreme Court is expected to rule on the future of federal health care exchanges under the Affordable Care Act, Hill Democrats have taken a uniform policy stance: They are not ready to talk publicly about potential fixes in case the court ruling doesn't go their way.

Capitol Hill’s Women Hold Power Beyond Numbers

Capitol Hill’s Women Hold Power Beyond Numbers-rollcall: For the first time, two women are alone as the main competitors to become the same political party’s Senate candidate of choice. That much was guaranteed with the decision by Rep. Loretta Sanchez to enter the race for California’s open seat, where her principal opponent will be another Democrat, state Attorney General Kamala Harris. And if Sanchez ends up the winner in November 2016, she would become the nation’s first Latina senator.

FDA Funding In Cures Bill Complicated By Metrics, Appropriators

FDA Funding In Cures Bill Complicated By Metrics, Appropriators-thegraysheet: The wide-ranging reforms in the House 21st Century Cures bill have attracted a good measure of bipartisan support, but the lack of extra funding for FDA continues to be a source of tension.

Interest groups seek to add goodies to fast-moving FDA overhaul bill

Interest groups seek to add goodies to fast-moving FDA overhaul bill-modernhealthcare: WASHINGTON – Why is the nation's capital suddenly obsessed with biomedical innovation?
And why is the fruit of that obsession, the proposed 21st Century Cures Act, moving like a freight train through the usually deadlocked congressional process—even though some experts warn it could undermine the Food and Drug Administration's ability to protect the public from unproven and potentially unsafe new drugs and medical devices?

DEGETTE: ONGOING 'CURES' NEGOTIATIONS ON FDA FUNDING

DEGETTE: ONGOING 'CURES' NEGOTIATIONS ON FDA FUNDING-politico pro: Rep. Diana DeGette, who's working closely with E&C Chairman Fred Upton on the 21st Century Cures legislation, pushed hard on Thursday for including more FDA funding in the bill.

E&C Proceeds With Contentious Priority Review For Breakthrough Devices

E&C Proceeds With Contentious Priority Review For Breakthrough Devices-insidehealthpolicy: The latest version of the House 21st Century Cures draft pushes through a proposal to allow breakthrough medical devices -- including 510(k)s -- to receive priority FDA review, even though the measure received pushback from consumer and research advocates, as well as complaints from state Medicaid directors that expediting approval of devices through “breakthrough” designations could pose safety risks for Medicaid patients.

Device Consortium Tries To Shed Light on Patient Risk-Benefit Preferences

Device Consortium Tries To Shed Light on Patient Risk-Benefit Preferences-thegraysheet: The public-private Medical Device Innovation Consortium issued a report outlining strategies for incorporating patient preference data into device applications. Read our coverage and hear directly from MDIC CEO Bill Murray in an audio podcast interview included within.

FDA’s still waiting, but Upton promises new funding with Cures

FDA’s still waiting, but Upton promises new funding with Cures-politicalpro: FDA’s coffers once-again came up empty in the updated 21st Century Cures draft bill released Wednesday, but Energy and Commerce Chairman Fred Upton pledged that more funding will be added — and that a complete pay-for will be attached — when the full committee considers the bill next week.

Obama Tries to Revive Fast-Track Trade Bill After ‘SNAFU’

Obama Tries to Revive Fast-Track Trade Bill After‘SNAFU’-rollcall: President Barack Obama — and Senate Democratic leaders — are working to resurrect his trade agenda, according to aides on the Hill and in the administration.

Interest groups seek to add goodies to fast-moving FDA overhaul bill

Interest groups seek to add goodies to fast-moving FDA overhaul bill-modernhealthcare: Observers say nearly every sector of the healthcare industry—even those that seem only tangentially related to the subject of the bipartisan legislation—has gotten involved in lobbying the 21st century cures bill. They all see opportunities to get their pet causes through the otherwise frozen partisan impasse.

Loretta Sanchez May Announce California Senate Bid

Loretta Sanchez May Announce California Senate Bid-rollcall: Rep. Loretta Sanchez, D-Calif., may announce a bid for Senate in the Golden State Thursday, which would set up a primary in the open-seat race to replace retiring Democratic Sen. Barbara Boxer.

Democratic Representatives Push For Medical Device Tax Repeal

Democratic Representatives Push For Medical Device Tax Repeal-insidehealthpolicy: A group of 18 Democratic representatives -- led by Rep. Scott Peters (CA) -- urged House Speaker John Boehner (R-OH) and Democratic Leader Nancy Pelosi (CA) to take up prior to Memorial Day a measure that would repeal the ACA's medical device tax.

Barack Obama’s Hillary Clinton Problem

Barack Obama’s Hillary Clinton Problem-rollcall: You knew it was coming: The White House is starting to get a case of Clintonitis. With Hillary Rodham Clinton the overwhelming favorite to carry the Democratic torch next year — and now an official candidate starting to spout policy positions — the White House has been forced to parry an ever-increasing barrage of questions.

ObamaCare official: Creating state exchange is 'very, very complex'

ObamaCare official: Creating state exchange is 'very, very complex'-thehill: The CEO of HealthCare.gov on Monday said states would not be able to immediately set up their own insurance marketplaces if the Supreme Court rules against ObamaCare this summer.

Dems to GOP: We’re ready to fix ObamaCare, why aren’t you?

Dems to GOP: We’re ready to fix ObamaCare, why aren’t you?-thehill: Democrats are chiding Republican leaders in Congress as standing in the way of improvements to ObamaCare that enjoy bipartisan support. More than a half-dozen proposed changes to the law boast approval from at least some Democrats, including legislation to repeal a controversial cost-cutting board for Medicare, which gained its 218th cosponsor this week.

Federal Cuts Would Be Major Blow to New York City’s Public Hospitals, Comptroller Says

Federal Cuts Would Be Major Blow to New York City’s Public Hospitals, Comptroller Says-newyorktimes: New York City’s public hospital system is looking at a major cash squeeze within four years if federal cuts to hospitals serving large numbers of poor and uninsured patients take place as scheduled, according to a report by the city comptroller, Scott M. Stringer, to be released on Monday. Beginning in 2017, the federal government will begin cutting subsidies to those hospitals...But Mr. Stringer’s report says that the city’s hospital system will not benefit as much as expected from the Affordable Care Act insurance plans because the system continues to serve a high proportion of undocumented immigrants, who are not eligible for coverage under the act.

Top Hill Staffer Says CMS Breakthrough Coverage Pulled Due to Cost

Top Hill Staffer Says CMS Breakthrough Coverage Pulled Due to Cost-thegraysheet: A House Energy and Commerce staffer said the committee dropped a Medicare reimbursement provision for breakthrough devices from their Cures draft bill because of cost but lawmakers haven't given up on the issue yet.

Washington's Interest in Precision Drugs is Innovation, Not Cost

Washington's Interest in Precision Drugs is Innovation, Not Cost-nationaljournal: As House, Senate, and White House attention shifts toward biomedical innovation, the high cost of specialty drugs remains unaddressed.

When a hospital closes, can a community's health improve?

When a hospital closes, can a community's health improve?-modernhealthcare: Hospital closures may not be bad news for the health of a community

Republicans finally get their budget

Republicans finally get their budget-politico: The Senate last night cleared the House-passed budget agreement that includes language to repeal Obamacare. The spending blueprint, passed by a 51-48 vote, paves the way for repeal using “reconciliation” — a maneuver that requires just a simple majority to pass legislation without the threat of a filibuster in the Senate. That means it can reach the president’s desk — where it will surely be vetoed — without help from Democrats.

UDI Goes Public: Beta Device Identifier Database Now Online

UDI Goes Public: Beta Device Identifier Database Now Online-graysheet: FDA has launched the beta version of AccessGUDID as the publicly available face of the Global Unique Device Identification Database. As of May 4, there are 48,093 device records in the searchable system.