McConnell reassures GOP on Obamacare opposition

McConnell reassures GOP on Obamacare opposition-politico: McConnell’s comments Tuesday to Neil Cavuto that a standalone repeal vote would require 60 votes and a presidential signature were taken as a change in position from the Kentucky senator’s frequent references to the goal of repealing the health care law “root and branch.” NPR posted a headline that “McConnell Concedes GOP Senate Will Not Mean Obamacare Repeal” while the Senate Conservatives Fund likened it to a “surrender.”

Ten Senate races go down to the wire

Ten Senate races go down to the wire-politico: It’s the largest and most wide-open Senate battlefield in more than a decade: 10 races, all neck-and-neck affairs headed into the final days of the campaign. And it’s not only that there are more competitive races this time around; it’s how close they are that has made the 2014 midterms different from previous cycles. The 10 close contests this year are all separated by 5 percentage points or less, according to RealClearPolitics polling averages as of Tuesday. Fewer races were that close right before recent midterms: eight in 2010 and five in 2006.

Gov't Officials: Industry Should Include Security Elements Early In Device Design

Gov't Officials: Industry Should Include Security Elements Early In Device Design-insidehealthpolicy:  Medical device manufacturers should include security elements in their early product designs to avoid usability tradeoffs and should anticipate new threats such as intentional vulnerabilities inserted into system software, government security experts said, responding to stakeholders' call for a balance between the usability and security of a device. The discussion occurred at an FDA cybersecurity workshop last week on ways to form collaborative approaches for medical device and healthcare cybersecurity, identify areas of vulnerability and outline considerations for manufacturers to develop security measures.

Critics Call FDA Third-Party Social Media Guidance ‘Overbroad’

Critics Call FDA Third-Party Social Media Guidance ‘Overbroad’-thegraysheet: Some stakeholders say a draft guidance released by FDA this summer on how manufacturers should consider interacting with third-parties online when talking about their products is overly broad and goes beyond the agency’s statutory authority. The “Guidance for Industry: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices” states companies are not required to correct potentially misleading information posted by third parties on social media. However, they are responsible for tweets and posts that are owned, controlled, created, influenced or endorsed by them.

Study: $250K malpractice cap cuts awards

Study: $250K malpractice cap cuts awards-politico: The study says that if the intent of caps is to lower the expected cost of medical liability for the average physician, the findings suggest that more restrictive caps are the only ones likely to have a significant effect. However, if the goal is to reduce extreme verdicts in outlier cases, a less restrictive cap might suffice.

Key Barack Obama aides eye White House exits

Key Barack Obama aides eye White House exits-politico: White House chief of staff Denis McDonough has asked senior aides to tell him if they’re going to stick around for President Barack Obama’s final two years in office, with a West Wing restructuring after the midterms possible. The process, which began in recent weeks, is focused on keeping people at the White House, with the expectation among senior administration officials that whoever’s in place next summer would remain through the end of the presidency.

New EC Leadership Backpedals: EU Device Oversight Will Stay In Health Division

New EC Leadership Backpedals: EU Device Oversight Will Stay In Health Division-thegraysheet: Oversight of medical device and drug policy in the European Union will remain with the European Commission’s health directorate (DG Sanco), and not be switched to the internal markets/industry directorate (DG ENTR) as previously planned. The news was announced just before the European Parliament voted Oct. 22 in favor of the new European Commission, led by President Jean-Claude Juncker, which will officially begin work on Nov. 1. There were 423 votes for the new commission and its new group of commissioners, 209 votes against and 67 abstentions.

Indian Government Supports Country-Specific Device Labels

Indian Government Supports Country-Specific Device Labels-thegraysheet: The Indian government has promulgated new national requirements on the labeling of medical devices. The new rules were published on September 25 and will apply with immediate effect. They are welcomed by the medtech industry as they allow India-specific labels to be affixed on to devices after they are imported into the country.

CMS Assesses Parallel Review; Device Industry Urges Continued Funding

CMS Assesses Parallel Review; Device Industry Urges Continued Funding-insidehealthpolicy: CHICAGO – A CMS official told device industry representatives the agency plans to evaluate whether changes or improvements are needed to the FDA/CMS parallel review program, as the two agencies laud their first parallel review product approval and enter the last year of the pilot in 2015. Industry supporters of the program worry that its funding could end, and Exact Sciences Corporation – the one company that saw success with the program – is trying to build support on Capitol Hill to continue the effort.

HHS' HIT Advisors Say Provider Progress On ICD-10 Prep Slowed By Delay

HHS' HIT Advisors Say Provider Progress On ICD-10 Prep Slowed By Delay-insidehealthpolicy: HHS' health information technology advisors say health plans and vendors are making progress with their ICD-10 preparations, but Congress' decision to delay implementation of the new code set has posed hurdles because providers have slowed down efforts to prep for the transition or even put them on hold. The advisors recently warned HHS Secretary Sylvia Burwell that there will be a “significant disruption” on Oct. 1, 2015, when the new CMS coding system is slated to go live, unless all parts of the industry make a concerted effort to continue moving forward with ICD-10 preparations.

CMS Pre-Pays Bonuses To Wire Up Of ACOs In Rural, Underserved Areas

CMS Pre-Pays Bonuses To Wire Up Of ACOs In Rural, Underserved Areas-insidehealthpolicy: CMS has decided to loan money to ACOs in rural and underserved areas in response to complaints that some accountable care organizations can’t afford the information technology systems or the changes to their practices that are needed to perform well enough to receive bonuses.

MedPAC Looks To Give Hospitals Flexibility In Steering Patients To Post-Acute Care Providers

MedPAC Looks To Give Hospitals Flexibility In Steering Patients To Post-Acute Care Providers-insidehealthpolicy:  Congressional Medicare advisers hope to come up with proposals that would give hospitals more flexibility in steering fee-for-service Medicare beneficiaries to preferred high-quality post-acute care sites, after raising concerns Friday (Oct. 10) with private insurers' initiatives to manage post-acute care. The Medicare Payment Advisory Commission rejected private insurer models used in Medicare Advantage, such as post-acute care benefits managers or beneficiary incentives for using preferred networks, because of concerns these initiatives wouldn't work within the fee-for-service framework.

IMDRF Proposes Path To Sharing Device Safety Data Globally

IMDRF Proposes Path To Sharing Device Safety Data Globally-thegraysheet: The International Medical Device Regulators Forum is seeking feedback on how national agencies should best exchange information on serious public health issues with medical devices. IMDRF is revamping the existing program on the exchange of national competent authority reports (NCARs). Participation in the revised program will be restricted to the countries or jurisdictions that are represented on the IMDRF management committee: Australia, Brazil, Canada, China, Europe, Japan, Russia and the U.S.

Fact-checking the North Carolina Senate race

Fact-checking the North Carolina Senate race-politico: The North Carolina Senate race pits incumbent Democratic Sen. Kay Hagan against Republican challenger Thom Tillis. While the two campaigns have aggressively attacked each another, they’ve had a lot of help from outside supporters as well. So far, the race has attracted at least $37 million in spending by outside groups, the most of any fall contest, according to a Sunlight Foundation analysis of Federal Election Commission data. Of that amount, more than $25 million has been spent on attack ads — more than $6.5 million against Hagan and nearly $19 million opposing Tillis.

Device Firms Eye Rocketing Pay-For-Performance Insurance Plans Warily

Device Firms Eye Rocketing Pay-For-Performance Insurance Plans Warily-thegraysheet: “This study highlights that patient access to innovative medical devices and diagnostics is facing a double hit,” said AdvaMed CEO Stephen Ubl. “Insurers are adopting new payment models that emphasize cost reduction and raising evidence requirements for coverage.”

CDRH, ORA Plan Specialized Field Force, And To Build On “Case for Quality”

CDRH, ORA Plan Specialized Field Force, And To Build On “Case for Quality”-thegraysheet: FDA’s Office of Regulatory Affairs will establish a more specialized unit of device-focused field investigators under a CDRH-ORA program alignment action plan  (PDF)posted Oct. 7. CDRH will work together with ORA throughout the current fiscal year to develop a plan for establishing a “medical device inspectorate,” and a separate mammography quality inspectorate, under the steps announced this week. In addition, the departments will hatch a plan for creating a CDRH-ORA medical device and radiological health compliance group.

Communication glitches all too common in hospitals

Communication glitches all too common in hospitals-politico:Communication mishaps in hospitals may arise from clunky electronic records systems, from misread scribbles on slips of paper or even simple slips of the tongue. Highly trained people can misunderstand each other and certainly patients. Communicating life and death health information can be like a giant game of “telephone” — with deadly consequences.

Consumer Advocates Worry PCORI's Peer-Review Plan Could Delay Access To CER Findings

Consumer Advocates Worry PCORI's Peer-Review Plan Could Delay Access To CER Findings-insidehealthpolicy: Consumer advocates are concerned about the Patient-Centered Outcomes Research Institute's plan for conducting peer reviews of publicly released research findings as mandated by the Affordable Care Act. Groups like Families USA and the National Consumers League say they are concerned that the draft review and publication process released by the institute last month is too lengthy and could delay patient and physician access to significant comparative effectiveness research (CER) findings.

Our first dive into the new Open Payments system

Our first dive into the new Open Payments system-massdevice:  The launch of the so-called Open Payments website, mandated under a provision of the Affordable Care Act, was far from glitch-free: Some users encountered long delays and sometimes error messages trying to access its seven data tables. Also, the site didn't provide consumers with an easy-to-use lookup tool, a single place to search for a doctor's name and see all results across data files.

No Devices on FDA Orphan Research Grant List

No Devices on FDA Orphan Research Grant List-thegraysheet: “The FDA is in a unique position to help those who suffer from rare diseases by offering several important incentives to promote the development of products for rare diseases, one of which is this grants program,” said Gayatri Rao, director of the FDA’s Office of Orphan Product Development. “The grants awarded this year support much-needed research in difficult-to-treat diseases that have little, or no, available treatment options.”

CMS Lets Context On Doc Pay Reports Stand In Open Payments Database

CMS Lets Context On Doc Pay Reports Stand In Open Payments Database-thegraysheet: CMS has allowed industry “context” statements about individual payments they made to physicians and teaching hospitals to remain unaltered from how they were framed in company reports, in the Open Payments database released to the public by the agency Sept. 30. In addition, CMS is providing general contextual information on the Open Payments website, including descriptions of what the different “nature of payments categories, including consulting fees, research payments, and honorariums mean, with examples.

FDA Formally Unveils LDT Draft Guidances Detailing Notification, Reporting Requirements

FDA Formally Unveils LDT Draft Guidances Detailing Notification, Reporting Requirements-insidehealthpolicy: FDA Tuesday (Sept. 30) released two draft guidance documents outlining how it plans to oversee laboratory developed tests, and the documents -- once finalized -- will set in motion notification, approval and reporting requirements for laboratories. The new documents delve into differing requirements for how laboratories would have to report adverse events when they are considered a facility using and manufacturing the test.

Low Physician Registration Spurs Concern Over Open Payments' Accuracy

Low Physician Registration Spurs Concern Over Open Payments' Accuracy-insidehealthpolicy: Some stakeholders expressed concern Tuesday (Sept. 30) about the relatively small number of physicians who registered for the Open Payments system, saying the website's accuracy could be questionable because of the large number of physicians that didn't register and were therefore unable to dispute any industry payments inaccurately linked to them prior to publication of the site. The drug industry and other stakeholders also questioned whether the context CMS provided on the website was enough to help the public understand the payments from industry to doctors and offset any chilling effect on innovation.