Budget Committees Add ACA Repeal By Reconciliation To Conference Agreement

Budget Committees Add ACA Repeal By Reconciliation To Conference Agreement-insidehealthpolicy: House and Senate Budget committee leaders on Wednesday (April 29) agreed to repeal the Affordable Care Act through reconciliation in the fiscal 2016 budget, according to a new budget conference report that also aims to balance the budget within 10 years and save more than $5 trillion.

California Bill to Force Drug Makers to Disclose Costs Stalls Again

California Bill to Force Drug Makers to Disclose Costs Stalls Again-wallstreetjournal: A vote on a closely watched California state bill that would force drug makers to disclose their costs was postponed yesterday, the second time this month the legislation failed to proceed after encountering opposition from the pharmaceutical industry

Refined ‘Cures’ Draft Retains Breakthrough Pathway, Device Reforms

Refined ‘Cures’ Draft Retains Breakthrough Pathway, Device Reforms-thegraysheet: But the April 29 updated draft of the broad-based House reform package for medical innovation is missing some significant items floated earlier this year, including a Medicare breakthrough device program, a revamp of diagnostics regulations and device supply-chain security reform.

Senators Push Breakthrough Pathway For Devices Bill That Mirrors 'Cures' Draft Language

Senators Push Breakthrough Pathway For Devices Bill That Mirrors 'Cures' Draft Language-insidehealthpolicy: Sens. Richard Burr (R-NC), Michael Bennet (D-CO) and Orrin Hatch (R-UT) introduced bipartisan legislation Thursday (April 23) that would create a breakthrough designation pathway for expedited FDA approval of medical devices -- a plan closely mirroring language in the House Energy and Commerce Committee's 21st Century Cures draft bill released in January.

Medicare-Provider Penalties, Incentives Detailed in Report

Medicare-Provider Penalties, Incentives Detailed in Report-wallstreetjournal: The Journal also breaks down a CMS report released last week about compliance with the Physician Quality Reporting System in 2013.

Trade Fight Galvanizing the Left

Trade Fight Galvanizing the Left-rollcall: With the first round of appropriations bills and a possible budget conference report on the House floor this week, the chamber’s progressive contingent is looking farther down the road at the storm brewing over so-called Trade Promotion Authority, or “fast track.”

Ultimate Burden Of Device Tax – After Deductions – Debated At Senate Hearing

Ultimate Burden Of Device Tax – After Deductions – Debated At Senate Hearing-thegraysheet: Sen. Debbie Stabenow, D-Mich., said the harsh impact of the device tax on industry after deductions are accounted for is less than a B. Braun official at an April 23 Senate Finance Health Care Subcommittee claims.

FDA Hoping To Shift Some ‘Cures’ Initiatives Toward User Fee Negotiations

FDA Hoping To Shift Some ‘Cures’ Initiatives Toward User Fee Negotiations-thegraysheet: As Rep. Upton signals an impending deal, Acting Commish Ostroff strikes a much more conciliatory tone than his predecessor did.

Tough Talk on Trade Between Wyden and Reid

Tough Talk on Trade Between Wyden and Reid-rollcall: Sen. Ron Wyden did not sound surprised by Minority Leader Harry Reid’s call Tuesday for him to slow down progress on Trade Promotion Authority legislation that was being marked up Wednesday afternoon.

Providers Warn Against New Sequestration Tactic In Trade Bill

Providers Warn Against New Sequestration Tactic In Trade Bill-insidehealthpolicy: Medical societies representing doctors, hospitals, nursing homes and home care warned lawmakers that their new Medicare sequestration tactic sets a bad precedent because, instead of merely extending sequestration, lawmakers now are considering increasing sequestration pay cuts, this time to help offset the cost of trade legislation. Providers also are angry that lawmakers are considering the Medicare cuts to pay for legislation that has nothing to do with Medicare.

Bill To Repeal Health Insurance Tax Earns Majority Support With Six Dems

Bill To Repeal Health Insurance Tax Earns Majority Support With Six Dems-insidehealthpolicy: A bipartisan majority in the House of Representatives now supports a bill to repeal the Affordable Care Act’s health insurance tax, with 218 cosponsors on board since Reps. Charles Boustany (R-LA) and Kyrsten Sinema (D-AZ) introduced the legislation Feb. 12.

Collecting Foreign Data? Come Talk To Us, FDA Says :: “The Gray Sheet” :: Pharma & Medtech Business Intelligence

Collecting Foreign Data? Come Talk To Us, FDA Says :: “The Gray Sheet” :: Pharma & Medtech Business Intelligence: "FDA has been accepting data from patients outside of the U.S. to support device approvals for years, but the sponsor should check with the agency in advance to ensure the foreign data meets the needs of the U.S. regulatory system, according to a new draft guidance. "

At Tax Time, No Public Backlash Over Obamacare’s Individual Mandate

At Tax Time, No Public Backlash Over Obamacare’s Individual Mandate-wallstreetjournal: Tax season has come and gone with no great outbreak of protest about the Affordable Care Act’s least popular provision: the individual mandate. This central element of the ACA was included to help ensure that the individual insurance market would have balanced pools of healthier people and sicker people to help spread insurance risk and keep premiums reasonable.

Day After SGR Repeal Law Signed, Medicare Offsets Resurface In Trade Bill

Day After SGR Repeal Law Signed, Medicare Offsets Resurface In Trade Bill-insidehealthpolicy: Lawmakers plan to pay for trade legislation by extending the Medicare sequestration, and health care providers are mobilizing against what they view as Congress' new habit of relying on Medicare offsets for unrelated legislation.

ACA doesn’t top public’s health care priorities

ACA doesn’t top public’s health care priorities-politicopro: Reforming the Affordable Care Act may be on the public’s health care wish list, but it only comes after making medications for chronic diseases affordable, ensuring adequate provider networks and increasing the transparency of health care quality and costs, according to a poll released Tuesday by the Kaiser Family Foundation.

Legislative Deadlines for Presidential Candidates to Watch

Legislative Deadlines for Presidential Candidates to Watch-rollcall: There's no shortage of deadlines in 2015 that will put the national media spotlight on Capitol Hill, and for what's likely to be four Republican senators making runs for the White House and their advisers, these moments will be an opportunity to distinguish themselves from fellow legislators -- and perhaps for the candidates running from governor's mansions or the business community.

GOP Is Split Over Bid to Repeal Health Law

GOP Is Split Over Bid to Repeal Health Law-thewallstreetjournal: Republicans in control of Congress have a special tool they can use to push legislation to President Barack Obama’s desk with a simple Senate majority. But they are divided on whether to use it on a repeal of the Affordable Care Act. Such legislation would almost certainly be vetoed by Mr. Obama, so some Republicans believe using the legislative maneuver, known as reconciliation, would waste a good opportunity to achieve other budget goals.

Obamacare repeal falls off Republicans' to-do list as law takes hold

Obamacare repeal falls off Republicans' to-do list as law takes hold-latimes: After five years and more than 50 votes in Congress, the Republican campaign to repeal the Affordable Care Act is essentially over. GOP congressional leaders, unable to roll back the law while President Obama remains in office and unwilling to again threaten a government shutdown to pressure him, are focused on other issues, including trade and tax reform.

Permanent Doc Pay Bill Heads To President’s Desk, Promotes Remote Monitoring

Permanent Doc Pay Bill Heads To President’s Desk, Promotes Remote Monitoring-thegraysheet: The Senate passed a House Medicare physician pay bill, setting a new permanent payment system for the program’s providers that will ultimately encourage value-based payments. The legislation also includes provisions on remote monitoring, gainsharing and durable medical equipment.

Trade Promotion Authority Bill Prioritizes Reimbursement Transparency

Trade Promotion Authority Bill Prioritizes Reimbursement Transparency-thegraysheet: Trade promotion authority legislation introduced April 16 in the Senate and House includes provisions that would prioritize transparency for foreign reimbursement schemes and eliminating price controls in ongoing and future international trade negotiations.

Industry: 'Cures' Expanded Access Proposal Might Stifle Trial Enrollment

'Cures' Expanded Access Proposal Might Stifle Trial Enrollment-insidehealthpolicy: The expanded access provisions contained within the 21st Century Cures draft bill -- which would require drug companies to be more transparent when it comes to expanded access decisions -- garnered support from patient groups but two drug companies raised concerns the measure could stifle patients' willingness to join clinical studies.

Doctors See Benefits and Risks in Medicare Changes

Doctors See Benefits and Risks in Medicare Changes-thenewyorktimes: Doctors and health policy experts have begun to take stock of the practical implications of the legislation, which seeks to move away from paying doctors solely on the volume of their services and toward reimbursing them based on the quality and value of the care they provide. Many said the legislation was short on details about how such quality will be measured, and others expressed apprehension about whether the system will be fair.

Is the Bipartisan 'Doc Fix' Bad News for Obamacare?

Is the Bipartisan 'Doc Fix' Bad News for Obamacare?-nationaljournal: Congress just passed a big bipartisan health care bill, overwhelmingly and on a tight timeline. Now, some Democrats might hope the Supreme Court didn't notice. Republicans and Democrats defied just about everyone's expectations by passing a permanent "doc fix" after punting on the issue for more than a decade. Tuesday's 98-2 vote in the Senate was the kind of thing that isn't supposed to happen, especially on health care policy, in a gridlocked Congress.

Medicaid Chiefs Cite Need To Keep Costs Low For ‘Cures’ Devices, Drugs

Medicaid Chiefs Cite Need To Keep Costs Low For ‘Cures’ Devices, Drugs-thegraysheet: State Medicaid directors are saying initiatives in the House 21st Century Cures draft bill to accelerate delivery of innovative devices and drugs will make them too costly for payers, and may inappropriately “lower the evidentiary standard” for device approvals.

Democratic Candidates Are Ready for Hillary Clinton

Democratic Candidates Are Ready for Hillary Clinton-rollcall: Hillary Rodham Clinton’s candidacy for president became official on Sunday, but Democrats already see the down-ballot benefits she brings as the presumptive nominee. Staring down Republican majorities in the House and Senate, Democrats have secured recruits in five top Senate contests. At the House level, where the process gets cranking later in the cycle, the party has landed their preferred candidates in a handful of targeted races.

Ted Cruz Will Oppose House’s Medicare-Reform Bill

Ted Cruz Will Oppose House’s Medicare-Reform Bill-nationaljournal: The Republican senators angling to become the party's next presidential candidate had the opportunity to vote on a major entitlement-reform bill Tuesday—and they were divided over it, opening the door for the issue to make an appearance in the primary campaign. The Senate overwhelmingly approved the permanent Medicare doc-fix bill, 92-8, and the White House has indicated that President Obama will sign the bill, which would put an end to one of Congress's most-hated rituals...Sens. Ted Cruz of Texas and Marco Rubio of Florida voted against the bill. Sens. Rand Paul of Kentucky and Lindsey Graham of South Carolina...voted for it.

A Busy and Bipartisan Tuesday

A Busy and Bipartisan Tuesday-rollcall: For all the talk of the death of bipartisanship, Tuesday’s busy legislative day in the Senate provided quite the counter-argument. A little more than a day after returning from a two-week recess, the legislative dam burst, with senators making significant headway on sticky issues such as the Iran nuclear deal, a rewrite of the No Child Left Behind law, a replacement for the payment formula for doctors who treat Medicare patients and possibly even the confirmation process for Loretta Lynch, President Barack Obama’s nominee for attorney general.

NAMD: Breakthrough Pathways In 'Cures' Draft Pose Safety Concerns For Medicaid Patients

NAMD: Breakthrough Pathways In 'Cures' Draft Pose Safety Concerns For Medicaid Patients-insidehealthpolicy: State Medicaid directors complain that proposals in House lawmakers' draft Cures bill to expedite approval of drugs and devices through “breakthrough” designations could pose safety risks for Medicaid patients.

Marco Rubio’s Presidential Bid Creates Open-Seat Scrum

Marco Rubio’s Presidential Bid Creates Open-Seat Scrum-rollcall: Marco Rubio on Monday became the third Republican senator to announce a bid for president and the first of the group to leave behind a competitive seat. Rubio vacating his seat in Florida in favor of national ambition gives the GOP another potentially strong White House contender. But it presents new challenges for Senate Republicans pushing to hold their newly acquired majority by leaving an expensive open seat in a state at the heart of the presidential election.

Standardized Device Labeling? CDRH Studies Practitioner Perceptions

Standardized Device Labeling? CDRH Studies Practitioner Perceptions-thegraysheet: The format of device labeling is controlled by the individual manufacturer, but CDRH is exploring whether health care practitioners can more easily find information from a more standardized device label template that includes a short-summary section. Industry advocates are skeptical that broad-scale standardization is feasible due to the diversity of devices and device users, but companies are assisting in the center’s plans to perform a cognitive study of clinicians this summer.

CMS Actuary Say House SGR Bill A Temporary Fix, Patch Needed In 10 Years; AMA Cries Foul

CMS Actuary Say House SGR Bill A Temporary Fix, Patch Needed In 10 Years; AMA Cries Foul-insidehealthpolicy: In a move blasted by the powerful physician lobby, the CMS chief actuary says the House SGR replacement bill, widely touted as permanent Medicare physician payment reform, is in reality only a temporary solution that Congress would have to revisit in 10 years to stave off payment cuts that by 2048 would lead to payment rates lower than those under the current Sustainable Growth Rate system. The American Medical Association called the findings “illogical, flawed and dangerous” and reasserted its press for the Senate to pass the House bill next week.

FDA Outlines Balance Between Premarket, Postmarket Device Studies

FDA Outlines Balance Between Premarket, Postmarket Device Studies-insidehealthpolicy: FDA issued final guidance giving specific examples of when the agency feels it is appropriate to use postmarket data in order to speed up the device premarket approval application (PMA) process. The guidance dovetails with a separate guidance, also issued Wednesday (April 8), launching the agency's Expedited Premarket Approval (EAP) program for medical devices intended for unmet medical needs, which is mirrored after expedited pathways for drugs.

Hillary Clinton Enters With an Edge, and a Long, Long Way to Fall

Hillary Clinton Enters With an Edge, and a Long, Long Way to Fall-nationaljournal: Hillary Clinton has 576 days. In a Sunday afternoon email to former staffers, campaign chairman John Podesta confirmed that Clinton is running for president—an announcement that ends months of speculation about when, where and how the former secretary of State would officially start a campaign that most have long seen coming.

Teaching Hospitals May Benefit From Schumer's Likely Ascension in Leadership

Teaching Hospitals May Benefit From Schumer's Likely Ascension in Leadership-rollcall: Teaching hospitals have an ally in New York Sen. Charles E. Schumer and are likely to benefit if, as expected, he becomes the Senate’s next Democratic leader. Schumer could leverage his newfound influence in Congress to increase medical education spending and Medicare payments to institutions.

Senate Returns to an Immediate ‘Doc Fix’ Deadline

Senate Returns to an Immediate ‘Doc Fix’ Deadline-rollcall: Lawmakers will already be facing a time crunch when the Senate returns Monday. The Centers for Medicare and Medicaid Services has been withholding payments to doctors treating Medicare patients to give Congress a window to work through a long-term resolution to the Sustainable Growth Rate problem that sees physicians regularly facing draconian cuts in payment rates without a patch known as a “doc fix.”

Two maps explain how much the Supreme Court could damage Obamacare

Two maps explain how much the Supreme Court could damage Obamacare-thewashingtonpost: We won't find out for another few months how the Supreme Court will rule on a crucial case regarding Obamacare subsidies. But new maps from the Washington Center for Equitable Growth help illustrate just how much is at stake, showing which states would be hit hardest if the Supreme Court struck down the subsidies that help people afford coverage on insurance marketplaces.

FDA Asks For More Industry Help To Train Staff

FDA Asks For More Industry Help To Train Staff-thegraysheet: CDRH is asking for another round of volunteers to allow officials to visit manufacturing and clinical facilities to get first-hand perspective of how they operate as part of the center's Experimental Learning Program.

FDA Launches Expedited Device Approval Program Without Including 510(k)s

FDA Launches Expedited Device Approval Program Without Including 510(k)s-insidehealthpolicy: FDA will begin accepting applications from industry next Wednesday (April 15) to participate in a major new program to expedite approval of medical devices that address unmet medical needs for life-threatening or irreversibly debilitating diseases, but the final program design unveiled April 8 is limited to premarket approval and de novo devices, rejecting industry's call for inclusion of 510(k)s.

Jeb Bush Calls for Privatizing Elements of Veterans Health Care

Jeb Bush Calls for Privatizing Elements of Veterans Health Care-wallstreetjournal: While Sen. Rand Paul (R., Ky.) was formally launching his 2016 presidential campaign Tuesday, still-not-a-candidate Jeb Bush was in Colorado, where he called for privatizing some parts of veterans’ health care.

Conservatives Push for Fully Paid 'Doc Fix' Deal

Conservatives Push for Fully Paid 'Doc Fix' Deal-rollcall: Momentum is building among conservative senators to scrap an exemption from budget laws in the House-passed "doc fix" deal, a move that would pressure Congress to offset $141 billion of the package's cost not currently paid for later this year, outside groups say.

FDA Guidance Allows Limited Foreign Data To Approve Devices With Postmarket Caveat

FDA Guidance Allows Limited Foreign Data To Approve Devices With Postmarket Caveat-thegraysheet: As FDA puts more emphasis on postmarket data collection in its PMA approval process, the agency has released a final guidance on balancing premarket and postmarket studies.

This Is the End for Washington’s Most Frenzied Lobbying Extravaganza

This Is the End for Washington’s Most Frenzied Lobbying Extravaganza-nationaljournal: When the Senate reconvenes next week, it is expected to quickly pass the House's bipartisan deal to permanently end the so-called Medicare "doc fix"—one of Capitol Hill's least favorite rituals. But while it was a routine headache for lawmakers, it has also been a lobbying bonanza for K Street and the special interests it represents.

What would Clinton do with Obamacare?

What would Clinton do with Obamacare?-washingtonexaminer: Hillary Clinton could finally get her chance to preside over health reform. More than two decades ago as first lady, she tried but failed to get a sweeping health care law through Congress. But if she wins the presidency next year, she'll inherit the executive reins on President Obama's signature Affordable Care Act seven years into it.

Physicians’ Tastes For Pricier Implants Not Always Improving Patient Results, Hospital Group Says

Physicians’ Tastes For Pricier Implants Not Always Improving Patient Results, Hospital Group Says-thegraysheet: UHC, an alliance of nonprofit academic centers, released a white paper finding that higher-priced physician preferences for orthopedic implants, coronary and peripheral stents and heart valves are increasing hospitals’ supply costs, but not necessarily improving patients’ outcomes.

Where Romneycare fell short — and what that could mean for Obamacare

Where Romneycare fell short — and what that could mean for Obamacare-washingtonpost: The landmark 2006 Massachusetts health-care law that inspired the federal overhaul didn't lead to a reduction in unnecessary and costly hospitalizations, and it didn't make the health-care system more fair for minority groups, according to a new study that may hold warnings for the Affordable Care Act.

36K sign-ups so far in special ObamaCare enrollment period

36K sign-ups so far in special ObamaCare enrollment period-thehill: About 36,000 people have signed up for ObamaCare plans through March 29, during a special extended enrollment period, the administration announced Wednesday.

Providers Optimistic Senate Will Pass SGR Bill Upon Return

Providers Optimistic Senate Will Pass SGR Bill Upon Return-insidehealthpolicy: Provider lobbyists say they are optimistic that the Senate will pass the House bill to replace the Sustainable Growth Rate formula upon return from recess, and one of the potential holds, Sen. Ben Sasse (R-NE), already said he will not impede a vote on the bill.

AdvaMed Rebrands Start-Up Lobbying Arm

AdvaMed Rebrands Start-Up Lobbying Arm-thegraysheet: The largest medical device industry lobby group is renaming its start-up company lobbying unit.

Coming Soon: Hillary Clinton's Presidential Announcement - NationalJournal.com

Coming Soon: Hillary Clinton's Presidential Announcement - NationalJournal.com: "After a busy month of paid and unpaid appearances across the country, capped by two speeches at the beginning of this week, the next item on Clinton's public schedule is likely to be an announcement that she's running for president.

Clinton will speak at two events Monday, one at an event for the Center for American Progress and AFSCME, and another at the ceremony for the Toner Prize for Excellence in Political Reporting. These speeches, both unpaid, are the final acts of Clinton's two-plus years since leaving the State Department, when she also wrote and promoted a memoir and campaigned for Democrats across the country in 2014."

Americans Don’t Feel the Slowdown in Health Costs

Americans Don’t Feel the Slowdown in Health Costs-thewallstreetjournal: National spending on health care and insurance premiums has risen at historically low rates in recent years. But...even when spending and premiums experienced record-low growth in 2013, only 3% of Americans said health costs had been rising slower than usual, and 52% said they had been growing faster than usual. The American people are not out to lunch; their view of the problem of health costs is very different from that of experts.

Japan's parliament passes Abe's plan for corporate tax cut

Japan's parliament passes Abe's plan for corporate tax cut-chicagotribune: Lawmakers in Japan voted to green-light a corporate tax cut plan championed by Japanese Prime Minister Shinzo Abe. Under the legislation, the corporate rate will be cut by 3.29 percentage points over two years. The current effective rate for corporations is about 35 percent and Abe has vowed to continue lowering the rate over the next five years.

Barack Obama says health care law has led to 50,000 fewer preventable hospital deaths

Barack Obama says health care law has led to 50,000 fewer preventable hospital deaths-thepolitifact.com: Politifact says that President Barack Obama’s claim that Obamacare’s crack down on preventable hospital readmissions — among the law’s other delivery reform efforts — has led to 50,000 fewer deaths, is “mostly true.”

FDA Lays Out Inner Workings Of Device Advisory Panels In Draft Guidance

FDA Lays Out Inner Workings Of Device Advisory Panels In Draft Guidance-thegraysheet: CDRH explains how it consults with its device advisory panels, types of panel meetings, deadlines for participating firms in an April 1 draft guidance. The guidance comes following recent CDRH-industry discussions on the impact of the panel process on PMA decision times. It also states panel meetings may be considered for 510(k), de novos and HDEs.