House passes Obamacare expatriate bill on second try

House passes Obamacare expatriate bill on second try-politico: The controversy arose from other sections of the bill which some Democrats said created big loopholes in the health law. Opponents, including some labor groups, said the language was so broad that it would allow insurers to offer plans that don’t comply with ACA standards to non-citizens working in the U.S. legally and their families. “I think we do need to fix the expatriate issue, but not by unfixing health care reform for millions of people,” said Rep. Sander Levin (D-Mich.), ranking member of the Ways and Means Committe

CMS Estimates New Rule Hikes Health Center Pay By As Much As 32 Percent

CMS Estimates New Rule Hikes Health Center Pay By As Much As 32 Percent-insidehealthpolicy: CMS issued Tuesday evening (April 29) the final version of a new ACA-required payment system for health centers that it estimates could increase the centers' pay by as much as 32 percent. Nevertheless, CMS still wants feedback on modifications of a few proposals, including a simplified method for calculating coinsurance when preventive and non-preventive services are on the same claim, Medicare-specific codes for encounter-based pay, and payment for chronic care management services.

Pew Pushes For Faster UDI Integration Into Electronic Health Records

Pew Pushes For Faster UDI Integration Into Electronic Health Records-thegraysheet: Pew Charitable Trusts’ medical device group is pushing the HHS Office of the National Coordinator for Health Information Technology to more deeply integrate unique device identifiers into electronic health record standards on a faster timeline than ONC has proposed. The non-profit made the case in April 28 comments filed in response to proposed 2015 certification standards that ONC circulated in February.

CMS To Phase In Fingerprint Background Checks For DME, Home Health

CMS To Phase In Fingerprint Background Checks For DME, Home Health-insidehealthpolicy: CMS plans to phase in fingerprint-based background checks beginning in 2014 for home health and durable medical equipment owners, and while those in the industry say the background checks have been expected for some time, there are still unanswered questions about how the checks will be carried out. The agency recently released a Medicare Learning Network article alerting the DME and home health community the background checks will be phased in beginning in 2014, though CMS says that initially not all providers and suppliers in the high-risk category will be part of the requirement

Blum Leaving CMS After Five Years Overseeing Medicare Reforms

Blum Leaving CMS After Five Years Overseeing Medicare Reforms-thegraysheet: CMS Principal Deputy Administrator Jonathan Blum is leaving his CMS post May 16, CMS Administrator Marilyn Tavenner announced in an April 22 email to staff. Blum, who has been directing CMS’ Medicare office, is leaving to pursue “new opportunities.” Sean Cavanaugh, deputy director of CMS’ Center for Medicare and Medicaid Innovation, has been tapped as director of the Center of Medicare, but nobody had been named principal deputy administrator as of Friday afternoon, April 25.

Democrats fear Obama could give in

Democrats fear Obama could give in-politico: Democrats have something else to fear after the November midterms besides just an all Republican-controlled Congress: President Barack Obama. With Obama’s political career winding down and poll numbers continuing to languish, his party brethren fret that their own president — forced to work with GOP majorities — would give away the store on key policy issues ranging from the budget to energy and trade. It’s a concern congressional Democrats have voiced every time Obama and Vice President Joe Biden tried to cut big fiscal deals with Republicans — and the panic is now more palpable with the growing prospect of a Senate GOP majority.

Democratic Mega-Donors Dominate Super PAC Race As Republicans Hide In 'Dark Money'

Democratic Mega-Donors Dominate Super PAC Race As Republicans Hide In 'Dark Money'-huffingtonpost: WASHINGTON -- As the U.S. heads into the third national election since the Supreme Court's Citizens United ruling, super PACs are still raking in the largest share of their contributions from those giving $500,000 or more. What's different this go-around is the sharp drop in the number of Republicans on the list of mega-donors.

FDA Hopes To Balance Upfront Time Investment With Easier Reviews In New PMA Program

FDA Hopes To Balance Upfront Time Investment With Easier Reviews In New PMA Program-thegraysheet: FDA device center officials hope they can balance the substantial resources that they would need to invest into products accepted into CDRH’s newly proposed “Expedited Access PMA” pathway with a more straightforward, less- intensive review process, but the jury is still out, Center Director Jeffrey Shuren says. “It may turn out that we spend more resources upfront with an innovator, but actually save some resources later on because we have been able to work out a regulatory pathway with them and we have been involved in being able to better understand the data as it develops,” Shuren said in an interview.

Danielle Moon, Head Of MA & Drug Plan Division, To Leave CMS In May

Danielle Moon, Head Of MA & Drug Plan Division, To Leave CMS In May-insideahealthpolicy: Danielle Moon, who heads the CMS division in charge of Medicare Advantage and drug plans, is leaving the agency for an outside consulting firm at the end of May, according to an April 23 internal agency email. Kathryn Coleman, currently the acting deputy director of the Medicare Drug & Health Plan Contract Administration Group, will become the acting director. Moon's departure is the second major personnel announcement in as many days. CMS Administrator Marilyn Tavenner announced on Tuesday that CMS Principal Deputy Administrator Jon Blum is leaving the agency.

Medtech tax: Scott Brown's back on the attack | MassDevice.com On Call

Medtech tax: Scott Brown's back on the attack-massdevice: MASSDEVICE ON CALL — Returning senate hopeful Scott Brown (R-N.H.) renewed his once-fervent call for repeal of the medical device tax, telling reporters during a tour of Gamma Medica that the levy is "just a money grab to fund Obamacare." Brown this week toured imaging devices maker Gamma, where executives told him that the tax will prevent the company from hiring at least 2 new workers or investing in R&D this year. Brown, a former Massachusetts senator who announced his bid for New Hampshire earlier this month, called the tax "a job killer."

Leap Ahead With EAP? FDA Proposes New Expedited PMA Pathway

Leap Ahead With EAP? FDA Proposes New Expedited PMA Pathway-thegraysheet: FDA’s newly proposed accelerated PMA program may have a long name, but the agency hopes it will significantly shorten the time to market for a select set of devices that target unmet needs for the most serious conditions. The “Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions,” or EAP, was introduced today in a draft guidance (PDF), after CDRH signaled plans for the program earlier this year.

FDA floats expedited approval for unmet needs

FDA floats expedited approval for unmet needs-massdevice: The FDA said the "Expedited Access Pre-market Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions" would feature "earlier and more interactive engagement with FDA staff – including the involvement of senior management and a collaboratively developed plan for collecting the scientific and clinical data to support approval."

Ted Cruz's Worst Nightmare Is Coming True Obamacare is working.

Ted Cruz's Worst Nightmare Is Coming True Obamacare is working-politico: Cruz’s nightmare, and the left’s long-held dream, has come true. Finally, after years of failed reform efforts, the U.S. government is actually trying to provide affordable health coverage for all. And it’s working, despite Republicans’ relentless attempts to deep-six the law. As a result, the politics of Obamacare will never be the same.

Industry: FDA Oversteps Advertising, Labeling Authority In Social Media Guide

Industry: FDA Oversteps Advertising, Labeling Authority In Social Media Guide-insidehealthpolicy: Drug companies warn there could be "statutory and constitutional consequences" if FDA does not revise its social media guidance to clarify that not all company communications fall under the agency's authority for advertising and labeling. Drug industry groups also raise concerns with how FDA determines when manufacturers are responsible for content posted to third-party websites, particularly taking issue with the fact that exerting influence over a site would constitute control over its content.

Republicans Making Bold Play For Oregon Senate Seat

Republicans Making Bold Play For Oregon Senate Seat-huffingtonpost: LAKE OSWEGO, Ore. (AP) — The GOP is making a bold play for a U.S. Senate seat in reliably Democratic Oregon, where a Republican hasn't been elected to a statewide office in more than a decade. Republicans back in Washington think they've found the right candidate in Monica Wehby, a children's brain surgeon who's raised more than $1 million and put her early opposition to President Barack Obama's health care law at the center of her campaign.

Firms Must Be Proactive About Live-Case Demo Plans For IDE Devices – FDA Draft Guidance

Firms Must Be Proactive About Live-Case Demo Plans For IDE Devices – FDA Draft Guidance-thegraysheet: FDA wants sponsors of investigational device exemption applications to consider in advance whether the experimental device will be used in a live-case demonstration. On April 17, the agency released a draft guidance (PDF) listing the “important information that should be provided in an original investigational device exemption (IDE) application or a supplement to an IDE application when a sponsor anticipates including a live case presentation during a clinical investigation.” This guidance also provides advice to institutional review boards (IRBs) on factors to weigh when considering participation in an investigation that will include live case presentation

FDA works with China to ensure medical-product safety

FDA works with China to ensure medical-product safety-massdevice: Americans benefit greatly from medical products produced by other countries. Approximately 40 percent of finished drugs in the United States come from overseas, as well as more than 50 percent of all medical devices. About 80 percent of the manufacturers of active pharmaceutical ingredients are located outside the United States.

Obama argues healthcare law is working, rejects Republican criticism

Obama argues healthcare law is working, rejects Republican criticism-reuters: Obama's remarks reflected deep concerns at the White House that Republicans may be able to topple Democrats from control of the U.S. Senate in November elections and build on their majority in the House of Representatives. A Republican-run Congress would make legislative achievements in Obama's last two years in office difficult.

Report pushes for pricing transparency in health care

Report pushes for pricing transparency in health care-politico: Key players in the health care industry want to help consumers find out how much they will pay for a medical visit or procedure — well before it takes place. A report released Wednesday by a coalition of hospitals, insurers, doctors and consumer advocates recommends the ways providers can make that information easily available. An accompanying guide tells consumers how to go about getting i

Efforts Accelerate To Add Unique Device IDs To Insurance Claims

Efforts Accelerate To Add Unique Device IDs To Insurance Claims-thegraysheet: Health care and consumer groups are trying to take advantage of a narrow window of opportunity to have unique device identifier information incorporated into health insurance claims as soon as possible to facilitate better data collection and more effective product recalls.The Accredited Standards Committee X12, the organization that oversees the standards for what can be included in electronic insurance claims, is exploring changes to claims forms, and it could be a few years until the ASC X12 group considers revisions again.

No top Medicare billers among docs in Congress

No top Medicare billers among docs in Congress-politico: The doctors in Congress don’t appear to be breaking Medicare’s bank, but the government’s massive payment disclosure Wednesday shows that some of their family members have brought in sizable sums. Of the 24 House and Senate members who are physicians, just four collected Medicare reimbursements in 2012, according to the CMS database of 2012 billings.

Despite Draft Framework, Health IT Legislation Still Needed, Senators Say

Despite Draft Framework, Health IT Legislation Still Needed, Senators Say-thegraysheet: Senators advocating for a minimized FDA role in health information technology oversight praised some aspects of a health IT regulatory framework proposed last week by three federal agencies, but they also insisted that legislation to curb FDA’s authority remains necessary.

Recent FDA Software Recall Re-Ignites Debate Around HIT Legislation

Recent FDA Software Recall Re-Ignites Debate Around HIT Legislation-insidehealthpolicy: FDA made it clear with its class I recall of McKesson Technologies' anesthesia system -- clinical decision software that is the subject of recent legislative debate -- that it does not plan to just walk away from regulating CDS, Bradley Merrill Thompson, an attorney at Epstein, Becker & Green, said prior to Thursday's release of a tri-agency proposal for risk-based HIT regulation. The debate about how lawmakers should delineate regulatory oversight of health information technology is kicking up as stakeholders review the tri-agency proposal, which says FDA will focus on high-risk technology but leaves several regulatory areas fuzzy.

GOP confident about Ryan’s budget

GOP confident about Ryan’s budget-politico: Passing Rep. Paul Ryan’s budget? No sweat. House Republican leaders said they believe they turned a corner by the end of last week, quashing opposition to the Wisconsin Republican’s 2015 budget proposal and laying the groundwork to clear one of the last major pieces of legislation before the midterm election.

CMS plans unprecedented dump of Medicare data

CMS plans unprecedented dump of Medicare data-massdevice: MASSDEVICE ON CALL — White House officials announced that they plan to make public a rich reservoir of data Medicare payments unlike any publicized before, perhaps as early as next week. The release will include payments made in 2012 to individual doctors, covering some 880,000 healthcare providers, according to the Wall Street Journal. The move is expected to help healthcare watchdogs curb fraud and examine usage trends.

Tri-Agency HIT Report Pushes 'Light Touch' Oversight, Sets Up New Center

Tri-Agency HIT Report Pushes 'Light Touch' Oversight, Sets Up New Center-insidehealthpolicy:  FDA, the Office of the National Coordinator for Health IT and the Federal Communications Commission Thursday (April 3) issued a long-awaited proposal for a tri-agency, risk-based framework that breaks health information technology into three categories -- administrative health, health management and medical devices -- and limits FDA oversight to high-risk technology. Under the proposal, FDA would continue to regulate health IT systems that function as medical devices, including computer-aided diagnostics, but would not extend its authority to clinical decision support software categorized as health management IT.

Eshoo outlines health research funding bill

Eshoo outlines health research funding bill-massdevice: Rep. Anna Eshoo, one of the Democrats racing to lead the party on the powerful House Energy and Commerce Committee next year, introduced a bill on Thursday to grant $150 billion in new health research funding. The bill would set up a mandatory trust fund for the National Institutes of Health and other health programs, including the CDC. It would not be subject to the annual appropriations process and would authorize the $150 billion over 10 years.

New Cast Of Lawmakers Might Reshape SGR-Replacement Deal In 2015

New Cast Of Lawmakers Might Reshape SGR-Replacement Deal In 2015-insidehealthpolicy: When the 17th SGR patch expires next year, it's possible that this year's ballyhooed bicameral, bipartisan deal on a replacement for the Sustainable Growth Rate formula will be renegotiated because there will be a new cast of lawmakers in charge of the legislation and the Republicans might control the Senate, lobbyists say. Also, if the price of reforming Medicare physician reimbursement goes up, the perennial problem of paying for it will get worse.

New law in Brazil changes enforcement of BGMP requirements for certain medical devices

New law in Brazil changes enforcement of BGMP requirements for certain medical devices-massdevice: For Class I and II lower-risk devices registered with ANVISA and included on the regulator's IN 2/2011 exception list, as well as for Class II in vitro diagnostic (IVD) devices, Brazilian Good Manufacturing Practice (BGMP) certification and fee requirements have been removed. Previously, devices included in IN 2/2011 – such as sterilization and disinfection equipment, blood component processing equipment, resonance imaging equipment, gels, creams and liquids that come into contact with the body, contact lenses, and software that edits medical images – required BGMP certification in order to obtain ANVISA approval. Now, IN 2/2011 devices must still go through the full “registro” application process, but without the BGMP certification requisite.

Paul Ryan budget faces bumps amid GOP dissent

Paul Ryan budget faces bumps amid GOP dissent-politico: As Rep. Paul Ryan was laying out his Path to Prosperity budget Wednesday, Republican leadership was working behind the scenes to make sure there was a path for passage. With roughly one week until a planned floor vote, an unexpected hiccup has surfaced: A small pocket of Republicans are threatening to vote against the Budget Committee chairman’s proposal because they are angry about a controversial parliamentary maneuver GOP leadership deployed last week on the so-called doc fix.

Reid set to lead Dems, in majority or not

Reid set to lead Dems, in majority or not-politico: Harry Reid says he’s ready to return as Senate Democratic leader — win or lose the majority this November — so long as his colleagues are ready to support him. He may get his wish. A wide cross section of the Senate Democratic Caucus said in interviews that they are willing to back Reid as either majority or minority leader in the next Congress — no matter how controversial the Nevada Democrat has become as part of the furious battle for control of the chamber this fall.

Appropriations and baseball are back

Appropriations and baseball are back-politico: Baseball’s back this week and with it, yes, appropriations. You laugh, but the two share a lot: the long grueling season, late summer nights, beaucoup numbers, dreams of past glory come October. And as the first spending bills roll out, no dream’s bigger than repeating that championship pennant run of 1996. Just as today, 1996 followed on a disastrous government shutdown. And Republicans in Congress worked then with a Democratic White House to make amends by passing before Oct. 1 all of the annual bills required to keep agencies operating for the next 12 months.

Corporate Lobbyists Assail Tax Overhaul They Once Cheered - NYTimes.com

Corporate Lobbyists Assail Tax Overhaul They Once Cheered - NYTimes.com: "But this gathering ended up serving a decidedly different purpose: the unofficial kickoff of a push to make sure that Mr. Camp’s tax plan dies, a campaign that is highly likely to succeed, particularly now that Mr. Camp himself essentially conceded defeat, announcing this week he will not seek re-election this year."

Global Med Device Authorities Vary In Adoption Of Standards

Global Med Device Authorities Vary In Adoption Of Standards-thegraysheet: Notable variation remains in the technical device standards that are recognized by major world governments and in the approach by different countries to adopting new standards, according to data presented last week at the International Medical Device Regulators Forum meeting in San Francisco.

Ron Wyden’s idealism hits political reality

Ron Wyden’s idealism hits political reality-politico: At a lunch with fellow Senate Democrats last week, an eager Ron Wyden was ready to pitch his plan to permanently deal with a perennial Washington problem: the “doc fix.” But when Wyden stood up to be recognized at the start of the lunch, Senate Majority Leader Harry Reid looked the other way, seemingly ignoring his new Finance Committee chairman. When Wyden tried to speak, Reid cut him off, allowing several other senators to address the caucus instead. Finally, Reid let him talk, with aides later explaining that he was simply trying to give Wyden plenty of time to address his colleagues.

Device tax: Indianapolis Governor petitions Obama for repeal

Device tax: Indianapolis Governor petitions Obama for repeal-massdevice: MASSDEVICE ON CALL — Indianapolis Governor Mike Pence (R) issued a formal letter to the White House yesterday, asking President Barack Obama to repeal the 2.3% medical device tax created in the Affordable Care Act. Pence asked for President Obama's support in "working with the Congress to repeal the medical device tax entirely," saying that the levy threatens 20,000 direct jobs and 55,000 total that rely on the medtech industry in Indiana alone.

Senate backs one-year 'doc fix' patch

Senate backs one-year 'doc fix' patch-politico: The Senate on Monday approved a Medicare physician payment bill that would prevent a cut in payments for one year, after lawmakers in both chambers failed to find a permanent solution to the long-simmering problem. The bill passed on a bipartisan 64-35 vote, and now heads to the president’s desk. Senate Finance Committee Chairman Ron Wyden opposed the patch in favor of a permanent fix.

GOP bill spurs fight over future of science funding

GOP bill spurs fight over future of science funding-politico: A sharp ideological divide over federally funded research is holding up attempts to reauthorize the National Science Foundation, as Republicans press for more control over which research projects get funded — and how much scientists should have to answer to Congress.

Medtech makers warn on new EU rules

Medtech makers warn on new EU rules-massdevice: MASSDEVICE ON CALL — Medical device makers that relocated to Europe to take advantage of its easier path to approval are worried about new European Union rules, the Financial Times reports. Companies such as Middle Peak Medical, which is developing a mitral valve implant, moved some of their operations to the EU to escape the FDA's more-stringent approval protocols. But the new EU rules could take a bite out of that advantage, they worry.

Groups Float Tax Credits, New CMS Pay Policies To Stem Drug Shortages

Groups Float Tax Credits, New CMS Pay Policies To Stem Drug Shortages-insidehealthpolicy: A slew of healthcare organizations coalesced around more than a dozen long-term solutions to address drug shortages, including possible use of corporate tax credits to incentivize firms that maintain quality programs, new CMS payment policies and Biomedical Advanced Research and Development Authority models, according to a newly released rundown of a 2013 summit on the issue.