FDA Removes Firms’ Responsibility To “Know” In Research-Use Only Final Guidance

FDA Removes Firms’ Responsibility To “Know” In Research-Use Only Final Guidance-graysheet: FDA final guidance (PDF) outlines plans to step up enforcement of companies that sell a test to labs for clinical diagnostic applications even though the test is labeled only for research. But the guidance, issued Nov. 25, removes language from a 2011 draft version that had troubled diagnostics firms because it appeared to put the onus on them to police the activities of their lab customers. The guidance, titled “Distribution of In Vitro Diagnostic Products Labeled for Research-Use Only or Investigational-Use Only,” tries to make clear that companies are at risk of enforcement if they take direct steps, in any way, to encourage use of their research-use or investigational-use only tests for clinical diagnostic indications.

New AdvaMed Exec Donald May Weighs In On Reimbursement Priorities

New AdvaMed Exec Donald May Weighs In On Reimbursement Priorities-graysheet: Medicare payment policy, including the 2014 final physician fee schedule and the hospital outpatient prospective payment system that are expected out by Nov. 27, is just one part of the job facing Donald May, the new executive vice president of payment and health care policy for AdvaMed. “The Gray Sheet” spoke with May, appointed to his new role with AdvaMed Nov. 7, to understand his responsibilities with the association, AdvaMed’s priorities for reimbursement policy next year and how his prior experience as vice president for policy at the American Hospital Association will contribute to his new role.

Obamacare ratings sink

Obamacare ratings sink-politico: Obamacare’s popularity sunk to a new low this month, according to a Kaiser Family Foundation tracking poll released this morning. Just one in three adults surveyed from Nov. 13-18 described their opinion of the health law as very or somewhat favorable, its poorest showing since the tracking poll began asking Americans in April 2010. Likewise, those with a “very unfavorable” opinion of the law rose sharply to 36 percent, the highest total yet.

Value-Based Payment Program In SGR Bill Is Not A 'Withhold' Measure

Value-Based Payment Program In SGR Bill Is Not A 'Withhold' Measure-insidehealthpolicy: Medicare would not initially withhold a portion of reimbursement from doctors then pay it back to those who perform well in the Value-Based Payment program included in the SGR-repeal proposal by the Senate Finance and House Ways & Means committees, congressional staff assured providers at a Brookings Institution event on Tuesday (Nov. 19). The staffers, when asked to explain the funding approach, said the performance payments instead would come from a pool of penalties assessed on poorly performing providers.

The House GOP’s Obamacare playbook

The House GOP’s Obamacare playbook-politico: The House Republican leadership is coordinating an aggressive push to keep Obamacare’s problems front and center both on Capitol Hill and around the country. The House GOP effort includes investigations by at least eight committees, subpoenas for testimony from key administration officials and an initiative by Rep. Darrell Issa, chairman of the House Oversight and Government Reform Committee, to hold hearings around the country to highlight Americans’ problems with the law.

A no good, very bad Obamacare day

A no good, very bad Obamacare day-politico: Obamacare had a no good, very bad day. Democrats on Wednesday threatened to back a Republican bill to restore the president’s broken promise that Americans can keep their coverage unless the White House comes up with an alternative, adding a political component to the president’s health law woes.

Camp wages own battle of sorts over ACA

Camp wages own battle of sorts over ACA-politico: Dave Camp is waging a different sort of battle against Obamacare. His Republican colleagues are finally getting traction in undercutting the president’s signature health-care law, and that’s proving to be unexpectedly bad news for the Ways and Means chairman.

New England's medtech startups shrug off national VC shortage

New England's medtech startups shrug off national VC shortage-massdevice: MASSDEVICE ON CALL — Medical device startups in New England appear to be enjoying a venture capital renaissance as their peers around the nation are forced to tighten their belts and look for alternative funding. Local companies raked in more than $500 million through 46 listed deals last year, setting a new 10-year high, and 2013 is on track to match, the Boston Business Journal reported.

AHCA Pushes Therapy Claims Review Reforms That Could Be Folded Into SGR Bill

AHCA Pushes Therapy Claims Review Reforms That Could Be Folded Into SGR Bill-insidehealthpolicy: The skilled nursing industry lobby group is floating a framework to reform the Medicare review process for therapy claims that a source close to the effort says potentially could be included in any short- or long-term solution to therapy caps as part of legislation to replace the flawed Medicare physician payment formula.

510(k) Program, Companion Dx Among Top FDA Guidance Priorities For FY 2014

510(k) Program, Companion Dx Among Top FDA Guidance Priorities For FY 2014-thegraysheet: The device center released its guidance priorities for fiscal year 2014; among them are final guidances on the 510(k) program and in vitro companion diagnostics, as well as a draft guidance on benefit-risk determinations in 510(k)s. As part of the 2012 medical device user fee agreement, FDA was required to keep an updated website with its guidance priority lists for the upcoming fiscal year. The “A-list” is composed of prioritized device guidance documents FDA plans to publish within the year. Whereas the “B-list” includes guidance documents that FDA plans to publish as resources permit.

Final Coverage-With-Evidence-Development Guidance Delayed By CMS Staff Cuts

Final Coverage-With-Evidence-Development Guidance Delayed By CMS Staff Cuts-thegraysheet: Staff cuts at CMS tied to the federal sequester are to blame for the agency’s delay in issuing a final coverage-with-evidence-development guidance document; industry has been anticipating the final policy since a draft document was released a year ago. A question that Louis Jacques, director of the coverage and analysis group at CMS gets a lot of lately is, “What’s going on with CED?”

New technical director requirements for some medical devices in Argentina

New technical director requirements for some medical devices in Argentina- massdevice: Emergo Group has learned that recent changes to Argentinean medical device regulator ANMAT requirements for medical device registration holders, distributors and importers has created a legal issue between pharmacists and biomedical engineers. Previously, ANMAT required registration holders to have biomedical engineers on staff to act as technical directors for medical devices sold in Argentina. Now, however, regulators are requiring registrants to have pharmacists act as technical directors for sterile and implantable devices, and biomedical engineers for all other device types.

Opinion: Democrats now see why tea party wants to delay Obamacare

Opinion: Democrats now see why tea party wants to delay Obamacare-politico: When congressional conservatives and Tea Party Patriots fought to delay Obamacare’s individual mandate during the debate over the partial government shutdown, Democrats engaged in some of the most incendiary name-calling Americans have heard in years. Rep. Nancy Pelosi of California called opponents “arsonists.” Senate Majority Leader Harry Reid called them “anarchists.” Other Democrats resorted to more colorful language, like “political terrorism,” and said their political foes were “guilty of murder.”

Medtech startups get creative amid VC shortage

Medtech startups get creative amid VC shortage-massdevice: MASSDEVICE ON CALL — The medtech venture capital shortage continues to plague young companies, with 2013 funding slated to be as much as 40% lower than it was 5 years ago.That means medtech startups are searching for unorthodox ways to fill their coffers, including by asking family members and local celebrities to kick in some cash, according to a Wall Street Journal report.

User fees: The alternative to tax hikes

User fees: The alternative to tax hikes-politico: Not quite taxes but still revenue, these charges occupy their own political limbo in Washington: small in the larger scheme of things yet worth billions of dollars over time. By nature they are narrow in scope and can provoke fierce resistance from those most affected — such as the powerful airline lobby. Yet each is a potential piece to help create the balance needed to get to a deal.

It's Senate Dems' turn to probe ACA 'train wreck'

It's Senate Dems' turn to probe ACA 'train wreck'-politico: Sen. Max Baucus’s infamous “train wreck” warning about Obamacare now seems almost clairvoyant. The Senate Finance Committee Chairman was sharply criticized by fellow Democrats for saying implementation of Obamacare could be a “train wreck” if the administration didn’t get its act together. Seven months later, the Montana Democrat’s remarks are resonating.

Journal Reprints Shouldn’t See The Light Of Sunshine, Medical Societies Say

Journal Reprints Shouldn’t See The Light Of Sunshine, Medical Societies Say-thegraysheet: Device and drug companies have been collecting physician payment data for the Sunshine Act since Aug. 1, but a coalition of medical societies is still hoping to exempt journal reprints from the reporting standards. The argument is mounted in an Oct. 28 letter (PDF) to HHS Secretary Kathleen Sebelius from 41 state medical boards and 33 medical associations, including the American Medical Association. The statute creating the Sunshine requirements specifically exempts “[e]ducational materials that directly benefit patients or are intended for patient use,” the medical groups note, yet CMS has “concluded that medical textbooks, reprints of peer reviewed scientific clinical journal articles and abstracts of these articles are ‘not directly beneficial to patients, nor are they intended for patient use.’”