The Obamacare enthusiasm gap

The Obamacare enthusiasm gap-politico: Irony alert: The Democrats’ biggest challenge this fall is to get their voters excited about a law that they asked for. Obamacare will be a huge voting issue for Republicans — that’s already clear. They’ll turn out in droves because they hate the law. What’s less clear is how Democrats will get their supporters to the polls to say, “Hey, thanks for health reform.”

CMS Will Hold Some Claims If SGR Cuts Go Into Effect

CMS Will Hold Some Claims If SGR Cuts Go Into Effect-insidehealthpolicy: CMS announced Friday (March 28) that it plans to hold claims affected by the flawed Medicare physician payment formula for 10 business days if a patch or fix is not passed to avoid the Sustainable Growth Rate cuts by midnight Monday. "CMS is hopeful that there will be congressional action to prevent the negative update from taking effect on April 1, 2014," the announcement says.

CDRH Recalls Report: Growing Recall Count Doesn’t Mean Device Quality Is In Decline

CDRH Recalls Report: Growing Recall Count Doesn’t Mean Device Quality Is In Decline-massdevice: Despite a steady yearly increase in medical device recalls, an adjusted analysis of the number of product corrections and removals actually lags behind industry growth, according to a 10-year retrospective report released this morning by CDRH. The device center drafted its report in response to a 2011 GAO recommendation that it perform an assessment to identify recall trends.

China Hopes To Implement Unique Device Identifier System By Year End

China Hopes To Implement Unique Device Identifier System By Year End-massdevice: Despite a steady yearly increase in medical device recalls, an adjusted analysis of the number of product corrections and removals actually lags behind industry growth, according to a 10-year retrospective report released this morning by CDRH. The device center drafted its report in response to a 2011 GAO recommendation that it perform an assessment to identify recall trends.

Post-Acute, Labs, Imaging On Short List To Pay For SGR Patch

Post-Acute, Labs, Imaging On Short List To Pay For SGR Patch-insidehealthpolicy: Post-acute care services, clinical laboratory tests and advanced imaging are on the short list of health care sectors being targeted to pay for overriding scheduled pay cuts for physician services under Medicare's Sustainable Growth Rate formula, several lobbyists said. The SGR-patch bill also might include a measure, taken from the House's SGR-replacement bill, to give doctors guidelines on when to order imaging procedures.

Love at first tweet: A look at medtech's 1st forays into the social network

Love at first tweet: A look at medtech's 1st forays into the social network-massdevice: First impressions can be daunting primarily because they can have a long-lasting influence on a relationship, but what does it mean to make a 1st impression online? Some of medtech's biggest companies have made themselves Twitter regulators, but each had to start somewhere. Here are some of the industry's 1st tweets:

Tenn. Sen. Alexander decries the medtech tax

Tenn. Sen. Alexander decries the medtech tax-massdevice: MASSDEVICE ON CALL — Sen. Lamar Alexander (R-Tenn.) is ramping up his opposition to the medical device tax, spending some time with his medtech stakeholders to renew his call to repeal the tax. Alexander convened a panel of Memphis-area medtech leaders, including Medtronic (NYSE:MDT) regulatory affairs senior director Ed Chin and Transnetyx president & CEO Robert Bean.

McKesson Tagged With Rare Class I Recall For Clinical Decision Support Software

McKesson Tagged With Rare Class I Recall For Clinical Decision Support Software-thegraysheet: The 510(k)-cleared McKesson Anesthesia Care system is intended to help anesthesiologists make decisions by managing their data – that is, eliminating some manual data entry, inputting it into the hospital’s electronic health record system and analyzing data to ensure proper care. A brochure distributed by McKesson also refers to the system’s capabilities for medications, including avoiding adverse drug events and properly administering antibiotics. The brochure also boasts that the system can better ensure care integration, particularly during care handoffs.

Major Post-Acute Pay Reforms Five Years Away In Bipartisan Draft Bill By W&M, Finance Panels

Major Post-Acute Pay Reforms Five Years Away In Bipartisan Draft Bill By W&M, Finance Panels-insidehealthpolicy: It would probably be five years before Congress tackles major reforms in post-acute care payment, such as site-neutral and bundled pay, according to a draft bipartisan bill floated Tuesday (March 18) by the House Ways & Means and Senate Finance committees. The legislative draft aims to avoid stinting on care by standardizing data so policymakers can compare patient outcomes across the four post-acute care settings, and most post-acute care providers are pleased that Congress is taking a measured approach.

What medical device companies should consider before outsourcing to an FDA registered contract manufacturer

What medical device companies should consider before outsourcing to an FDA registered contract manufacturer-massdevice: So you are thinking about outsourcing the production of your medical device to an FDA registered contract manufacturer? To help you with this significant business decision we have provided a general list of considerations as a means of assisting your efforts in identifying the appropriate opportunities that may be able to leverage the strengths of outsourcing and ensure you choose the right partner who can support your business objectives.

FDA no longer notarizing CDRH export certificates

FDA no longer notarizing CDRH export certificates-massdevice: The US Food and Drug Administration has stopped notarizing Center for Devices and Radiological Health export certificates including Certificates to Foreign Government (CFG), Certificates of Exportability and Non Clinical Research Use Only Certificates.

GOP health plan could be road to nowhere

GOP health plan could be road to nowhere-politico: Here’s the dirty secret about the House Republicans’ efforts to replace Obamacare: They haven’t even decided if they will hold a vote. Not to mention, the House GOP would still have to repeal Obamacare in order to implement whatever alternative health care plan they release, which isn’t going to happen as long as President Barack Obama is sitting in the Oval Office.

Senate Finance Staff Implore Doc Lobbyists To Get GOP To Support Wyden SGR Bill

Senate Finance Staff Implore Doc Lobbyists To Get GOP To Support Wyden SGR Bill-insidehealthpolicy: Senate Finance Committee staff held a meeting with several physician groups Thursday and urged them to get five GOP senators -- enough to achieve a filibuster-proof majority -- to support Chair Ron Wyden's (D-OR) bill to replace the Sustainable Growth Rate formula without paying for it, several lobbyists said. As of Friday lobbyists had not gotten any GOP senators to commit, a physician lobbyist said.

House passes SGR bill with mandate pay-for

House passes SGR bill with mandate pay-for-politico: A once-bipartisan proposal to finally reform the deeply flawed way that Medicare pays doctors succumbed Friday to the partisan politics of Obamacare, particularly the unpopular individual mandate. The House voted 238-181 to replace the payment formula — the complicated equation that for more than a decade has required annual “doc fixes” — and to pay for it by delaying Obamacare’s individual mandate for five years.

Louis Jacques On Coverage, Evidence And IDEs

Louis Jacques On Coverage, Evidence And IDEs-thegraysheet: After 10 years of leading CMS through a series of improvements and changes to the agency’s coverage and reimbursement policies, Louis Jacques, former director of the Coverage and Analysis Group within the Center for Clinical Standards, began a new chapter March 1 as chief clinical officer with ADVI, a health care advisory services firm.

CDRH’s Owen Faris: New Clinical Trials Program Will Speed Up IDE Approvals

CDRH’s Owen Faris: New Clinical Trials Program Will Speed Up IDE Approvals-thegraysheet: CDRH established a new clinical trials director position last month to implement a pre-market clinical trials program intended to reduce the time and number of review cycles for investigational device exemptions. Owen Faris took on the post in an acting capacity on Feb. 9, and he spoke to “The Gray Sheet” about his vision for the role on March 12.

Editorial: The medical device tax is still a bad idea

Editorial: The medical device tax is still a bad idea-massdevice: When President Barack Obama signed the Patient Protection & Affordable Care Act into law back in 2010, he set the stage for a controversy within a low-profile industry that eventually drew some high-profile attention: A 2.3% tax on U.S. sales of medical devices.

Medical device tax: At least $510M paid in 2013

Medical device tax: At least $510M paid in 2013-massdevice: The financial impact of the medical device tax appears to be much lower than originally feared, a MassDevice.com analysis shows, with the medtech industry paying at least $500 million on the 2.3% levy last year

Obama Budget Seeks Prior-Authorization Ability For All Medicare Fee-For-Service Items

Obama Budget Seeks Prior-Authorization Ability For All Medicare Fee-For-Service Items-thegraysheet: The Obama administration pressed its efforts to expand prior-authorization requirements for Medicare services in its fiscal year 2015 federal budget proposal. In the proposal submitted to Congress March 4, the administration repeated its unsuccessful request from last year that CMS be required to make physicians obtain pre-approval for power mobility devices or advanced imaging services. But, in a new proposal, this year’s budget request would also extend CMS’ authority to require prior-authorization to all Medicare fee-for-service items, “particularly those service items that are at the highest risk for improper payment.”

FDA Draft Guidance Extends Reprint Policy To Medical Reference Texts, Clinical Practice Guidelines

FDA Draft Guidance Extends Reprint Policy To Medical Reference Texts, Clinical Practice Guidelines-thegraysheet: FDA is revising its policy on the procedures that device companies should follow when they distribute journal articles and other publications that discuss unapproved uses of legally marketed products to health care providers. The new draft document is not much different from the agency’s 2009 final guidance on good reprint practices, but includes new sections on how these practices apply to medical reference texts and clinical practice guidelines.

Crist: Dems need to 'strengthen up' on Obamacare

Crist: Dems need to 'strengthen up' on Obamacare-politico: Effusive in his praise of President Barack Obama, former Florida Gov. Charlie Crist says Democrats need to "strengthen up" when it comes to Obamacare.  Asked why so many Democrats are keeping Obamacare at arm's length, Crist, who lauded Obamacare as the "right thing" for the country and the people of Florida, was unsure.   

 

The battle to become the next Darrell Issa

The battle to become the next Darrell Issa-politico: It’s an opportunity that has some Republicans salivating: becoming the next Darrell Issa. The California Republican’s perch atop the headline-grabbing House Oversight and Government Reform Committee doesn’t wrap up until the end of this year, but a high-profile group of Republicans is already jockeying to take his gavel.

Study: PAs, NPs Do Better Job of Health Education Than Docs

Study: PAs, NPs Do Better Job of Health Education Than Docs-medscape: Nurses and physician assistants (PAs) are more likely than physicians to offer tips on healthy living to patients with chronic illnesses during office visits, a new study shows, although none of the 3 providers do it regularly.

MedPAC Iffy on Patient-Centered Medical Homes

MedPAC Iffy on Patient-Centered Medical Homes-medpagetoday: WASHINGTON -- A congressional advisory body on Medicare cast doubt on the patient-centered medical home model, including some of its payment mechanisms.Several members of the Medicare Payment Advisory Commission (MedPAC) said during a public meeting Thursday that the patient-centered medical home (PCMH) model may not be all it's cracked up to be.

Washington Roundup: White House budget proposal for 2015 takes $3M away from CDRH

Washington Roundup: White House budget proposal for 2015 takes $3M away from CDRH -medicaldevicedaily: The Office of Management and Budget released a budget proposal for fiscal 2015, and the funding for operations at the Center for Devices and Radiological Health would take a hit of $3 million by one account. The Obama administration's proposal would boost funding for FDA as a whole by $25 million, however, with the agency's food center taking in an additional $20 million, while the drug center would snare an additional $12 million. One pertinent question is whether the budget proposal has any meaning given the two-year budget deal struck recently by the House and Senate.

FDA Blames Over-Reporting For Record-High Recall Count In 2013

FDA Blames Over-Reporting For Record-High Recall Count In 2013-thegraysheet: The medical device industry performed the most product recalls ever in calendar year 2013, a potentially costly state of affairs for manufacturers that could also shake customer loyalty. But FDA claims the increase is due to manufacturer over-reporting and sensitivity to media reports about problem products, not necessarily because device troubles are rampant.

FDA Device Budget Would Increase Only Due To User Fees Under 2015 Budget Request

FDA Device Budget Would Increase Only Due To User Fees Under 2015 Budget Request-thegraysheet: FDA’s device budget would increase by about $13 million in fiscal year 2015 under the Obama administration’s budget request, but that is only as a result of an increase in user fees. Otherwise, based only on appropriations from Congress, the center would see a slight decline from the proposal. The request, sent to Congress March 4, targets $318 million to FDA device functions, including CDRH and device-focused efforts by the Office of Regulatory Affairs, down from the FY 2014 estimated budget of $318 million. But the total requested device budget, including user fees, is $441 million, up from $428 million in 2014, according to budget documents.

President's Budget Leans Heavy On Value-Based Purchasing, But RAND Questions Savings

President's Budget Leans Heavy On Value-Based Purchasing, But RAND Questions Savings-insidehealthpolicy: The president's 2014 budget includes initiatives to expand Medicare value-based purchasing and strengthen quality incentives, and CMS Administrator Marilyn Tavenner said in an address this morning that leaning more heavily on value-based purchasing will be one of the agency's goals for 2014 and an ongoing project. But a RAND report also out Tuesday (March 4) points to mixed results on whether using such payment schemes, especially newer models, help improve quality and lower costs.

President Proposes Medicare Prior-Authorization Authority For All Fee-For-Service Items

President Proposes Medicare Prior-Authorization Authority For All Fee-For-Service Items-thegraysheet: In the proposal submitted to Congress March 4, the administration repeated its unsuccessful request from last year that would have required CMS to make physicians seek prior approval before ordering power mobility devices or advanced imaging services. But, in a new proposal, the budget request would also extend CMS’ authority to require prior authorization to all Medicare fee-for-service items, “particularly those service items that are at the highest risk for improper payment.”

When regulators pay for peer-review

When regulators pay for peer-review-massdevice: In the Fall of 2013, the ABMS single-handedly funded an entire supplement devoted to the MOC process in the Journal of Continuing Education in the Health Professions. This journal is published quarterly by the Alliance of Continuing Education in the Health Professions, the Society for Academic Continuing Medical Education, and the Council on CME of the Association for Hospital Medical Education. Not surprisingly, the articles published were uniformly favorable about the MOC process despite evidence to the contrary. The American Medical Association (who also stands to benefit from the process politically) was quick to provide a free link to the full pdf of the supplement from its AMA Wire news bulletin.

Industry Supports Device Development Tools, But Says: Show Me The Money

Industry Supports Device Development Tools, But Says: Show Me The Money-thegraysheet: FDA presented its ideas for the program and sought comments in a November 2013 draft guidance.  As the agency sees it, the medical device development tools program would speed the development and approval of new devices by creating a process for FDA to qualify sponsor-created tools and make them available for free to any other device developer. By tools, FDA means clinical outcome assessments, such as patient-reported or physician-reported rating scales; tests for detecting biomarkers; and in vitro, animal or computational models.

CDRH Employee Surveillance Went Too Far, OIG, Lawmakers Say

CDRH Employee Surveillance Went Too Far, OIG, Lawmakers Say-thegraysheet: CDRH Director Jeffrey Shuren went too far in the computer surveillance he permitted of five device center scientists beginning in 2010, according to a report from the HHS Office of Inspector General. But except for more bad press and potential implications for staff morale, it appears neither Shuren nor the agency are imminently facing any penalties for the matter.  OIG says that an updated internal computer-monitoring policy (PDF) issued by FDA last September, but not released until last week, pre-emptively addressed all of the reform recommendations made in the inspector’s report, released Feb. 26 in conjunction with a House Oversight and Investigations Committee hearing.