Tuesday, March 31, 2015

How the 2016 Republicans Will Fight Over the Future of Obamacare

How the 2016 Republicans Will Fight Over the Future of Obamacare-nationaljournal: Every Republican 2016 presidential hopeful is going to start their health care policy platform with repealing the Affordable Care Act. It is a central tenet of the faith. But what then? Conservative repeal-and-replace plans have popped up from time to time over the last five years, but rarely garnered more than token press coverage and have never received a full vote in front of Congress. In other words: There has been no vigorous debate that shapes a white paper into real policy.

FDA 'Taking a Very Light Touch' on Regulating the Apple Watch

FDA 'Taking a Very Light Touch' on Regulating the Apple Watch-bloomberg: With Apple Inc. and fellow Silicon Valley companies edging further into health care, the U.S. agency in charge of oversight says it will give the technology industry leeway to develop new products without aggressive regulation. Bakul Patel, who oversees the new wave of consumer-focused health products at the Food and Drug Administration, said most wearable gadgets such as the soon-to-be-released Apple Watch and health-focused applications for smartphones have a way to go before warranting close scrutiny from the agency.

Hamburg: Neither U.S. Nor EU Device Regulation Has It Completely Right


Hamburg: Neither U.S. Nor EU Device Regulation Has It Completely Right-thegraysheet: During her final public appearance at the National Press Club, outgoing FDA Commissioner Margaret Hamburg defended her tenure and said she was leaving a stronger FDA than the one she inherited. Asked about the agency's device regulatory process, she said she didn't know if FDA or Europe had struck the right balance but said more work needs to be done.

Monday, March 30, 2015

South L.A.'s MLK hospital will reopen with a new healthcare outlook

South L.A.'s MLK hospital will reopen with a new healthcare outlook-latimes: How do you build a hospital for the era of Obamacare? The LA Times takes a look at how a new hospital in South L.A. answers that question.

Hamburg: FDA Concerned ‘Cures’ Would Lower Standards, Provide Unfunded Mandates

Hamburg: FDA Concerned ‘Cures’ Would Lower Standards, Provide Unfunded Mandates-insidehealthpolicy: Outgoing FDA Commissioner Margaret Hamburg warned against lowering regulatory standards to bring products to market more quickly in what is likely her final formal address before she steps down at the end of the month.

On Schiavo Case, Bush Treads Lightly

On Schiavo Case, Bush Treads Lightly-wallstreetjournal: Jeb Bush rarely, if ever, trumpets one of his most enduring conservative credentials: his yearslong effort to save Terri Schiavo, a severely brain-damaged woman whose husband wanted to remove life support despite her parents’ objections.

Teenagers Face Early Death, on Their Terms

Teenagers Face Early Death, on Their Terms-thenewyorktimes: A national push to have end-of-life discussions before a patient is too sick to participate has focused largely on older adults....More recently, providers have begun approaching teenagers and young adults directly, giving them a voice in these difficult decisions, though parents retain legal authority for underage patients.

Friday, March 27, 2015

House Overwhelmingly Approves Bipartisan Medicare-Reform Bill

House Overwhelmingly Approves Bipartisan Medicare-Reform Bill-nationaljournal: The House easily cleared the bipartisan "doc-fix" deal Thursday, putting the maligned Medicare payment formula for doctors one step closer to its end and instituting significant reforms to the old-age insurance program.

Warm Fuzzies After Boehner-Pelosi SGR Deal Not Likely to Last

Warm Fuzzies After Boehner-Pelosi SGR Deal Not Likely to Last-rollcall: House lawmakers left for a two-week recess on a high note Thursday, with members of both parties banding together in nearly equal measure to pass a substantive piece of legislation. But unlike the longevity of the bill that permanently ends the "sustainable growth rate" used to calculate doctors' payments for Medicare, and extends for two years the Children's Health Insurance Program, it's highly doubtful the bipartisan comity will endure.

Republicans Open Second Front to Repeal Device Tax With Budget

Republicans Open Second Front to Repeal Device Tax With Budget-thegraysheet: While two bills are already under consideration in the current Congress to repeal a 2.3 percent medical device tax instituted as part of the Affordable Care Act, GOP lawmakers have proposed budgets that would repeal the excise tax

Wednesday, March 25, 2015

Congress May Have More Time on the 'Doc Fix'

Congress May Have More Time on the 'Doc Fix'-nationaljournal: The current doc-fix patch expires on March 31 and, as all the news coverage notes, if Congress doesn't act, doctors would face a 20 percent payment cut from Medicare. But it's a little more complicated than that. The Obama administration would likely to buy Congress a little time. Whether it'd be enough is another question.

Bipartisan Policy Center To Unveil FDA-Focused Medical Innovation Proposals By Summer

Bipartisan Policy Center To Unveil FDA-Focused Medical Innovation Proposals By Summer-insidehealthpolicy: As the Bipartisan Policy Center (BPC) last week launched its own medical innovation initiative, medical product experts, including a former FDA commissioner, said Congress, the White House and FDA should look to increase the patient perspective in innovative research and realign the incentive structure to encourage industry to pursue treatments earlier in the disease cycle in areas like cancer.

Why the ‘Doc Fix’ Deal Has Senate in Something of a Fix

Why the ‘Doc Fix’ Deal Has Senate in Something of a Fix-rollcall: The odds have crested the 50-50 threshold for what would surely become one of the year’s biggest legislative achievements — an overhaul of how doctors and other Medicare providers get paid. And the usual encrusted ideological positioning, at both ends of the political spectrum, is no longer the biggest obstacle.

Breakthrough Device Route, Registries On Wish List At Senate Hearing

Breakthrough Device Route, Registries On Wish List At Senate Hearing-thegraysheet: Industry stakeholders listed their priorities to improve the medical regulatory process and research during a second hearing at the Senate Health, Education, Labor and Pensions Committee which is working on its own version of the House's 21st Century Cures bill.

Monday, March 23, 2015

Congress to Weigh a Plan to Protect Medicare Fees and Children’s Insurance

Congress to Weigh a Plan to Protect Medicare Fees and Children’s Insurance-thenewyorktimes: Lobbyists will descend on Congress this week as lawmakers near a bipartisan agreement to finance health care for the oldest and youngest Americans, by revamping the payment of doctors under Medicare and by extending the Children’s Health Insurance Program.

Democrats Outline Floor Strategy for Budget Battle

Democrats Outline Floor Strategy for Budget Battle-rollcall: Senate and House Democrats face different challenges in responding to the budget blueprints on the floors of their respective chambers, but they're operating from much the same playbook.

SGR Replacement Bill Resurfaces In Congress

SGR Replacement Bill Resurfaces In Congress-thegraysheet: Lawmakers are taking another shot at permanently reforming the Medicare physician payment system. The plan so far does not contain any major provisions targeting device payments, but it is a work in progress.

TAVR Researchers Look To Lower-Risk Patients, Less Data Demands


TAVR Researchers Look To Lower-Risk Patients, Less Data Demands-thegraysheet: Edwards Lifesciences' Sapien 3 valve looked good at the annual American College of Cardiology conference, including in intermediate-risk patients. Could it mean less follow-up demands for future approvals?

Monday, March 16, 2015

FDA Sets Up Expedited Review Pathway For Certain Breakthrough Drugs

FDA Sets Up Expedited Review Pathway For Certain Breakthrough Drugs-insidehealthpolicy: FDA codified an expedited review pathway for breakthrough-designated drugs in a manual of policies and procedures (MAPP) released this week, instructing FDA review teams to act at least one month before the Prescription Drug User Fee Act (PDUFA) goal date for these applications.

Tuesday, March 10, 2015

ObamaCare case looms over GOP budget debate

ObamaCare case looms over GOP budget debate-thehill: Congressional Republicans are considering using a budget tool known as reconciliation to deliver a bill to President Obama’s desk outlining their party’s response to the Supreme Court case challenging ObamaCare. GOP aides say reconciliation is becoming an increasingly attractive option to avert the healthcare meltdown that could result from a ruling this June against ObamaCare in the King v. Burwell case.

In Forecasting Health Costs, Let Technology Be Your Guide

In Forecasting Health Costs, Let Technology Be Your Guide-thenewyorktimes: The pace of advances in health care technology has a lot to do with the pace of growth in health care costs.