FDA Investigator Answers Array Of Inspectional Questions

FDA Investigator Answers Array Of Inspectional Questions-thegraysheet: Lori Lawless, a medical device specialist and investigator in FDA’s Baltimore district office, answers six inspection-related questions and offers insight into how an agency audit should unfold.

AHA Asks Court To Make HHS Immediately Meet Appeals Turnaround Times

AHA Asks Court To Make HHS Immediately Meet Appeals Turnaround Times-insidehealthpolicy:  The American Hospital Association is asking a federal court to mandate HHS immediately meet the 90-day deadline for deciding an appeal at Medicare's third appeal level as the backlog continues to grow. The backlog, AHA says, is one of HHS' own making due to its aggressive contractors.

Minimally Invasive Surgery Adoption Varies Widely Across U.S.

Minimally Invasive Surgery Adoption Varies Widely Across U.S.-thegraysheet: Adoption of evidence-supported minimally invasive surgical techniques varies widely in the U.S., according to a study published online July 8 in the journal BMJ. Researchers reporting the data say the findings underscore a disparity in surgical care nationwide that should be addressed with better physician training and patient education. “Despite the extensive body of evidence to support the use of minimally invasive surgery, choice of surgery is often a matter of surgeon preference. Little is known about the current adoption of laparoscopy in US hospitals,” Michol Cooper and colleagues at Johns Hopkins University in Baltimore write.

FDA Budget Issues Creep Into Strategic Priorities

FDA Budget Issues Creep Into Strategic Priorities-thegraysheet: Budget constraints will have an increasing focus as FDA makes strategic decisions in the coming years. Agency officials included stewardship, such as doing more with less funding, among the cross-cutting strategic priorities in its draft strategic priorities document (PDF) for 2014-2018, alongside regulatory science, globalization, product safety and quality, and smart regulation. It appears to be a recognition that while FDA and its stakeholders fight on Capitol Hill to increase the budget, the agency cannot continue to expect an ideal funding level for all its needs.

Device Brand Names Unnecessary In Open Payments Database, Industry Says :: “The Gray Sheet”

Device Brand Names Unnecessary In Open Payments Database, Industry Says ::  “The Gray Sheet”: "Listing device brand names as part of physician payment disclosures to the Open Payments database would be difficult, and not meaningful, AdvaMed suggests. CMS has proposed updating its regulations to require device brand names to be included in Sunshine Act disclosures."

CMS Proposes Pay Rate For Primary-Care Code; Hikes Doctors Influence Over Pay Rates

CMS Proposes Pay Rate For Primary-Care Code; Hikes Doctors Influence Over Pay Rates-insidehealthpolicy: CMS on Thursday (July 3) proposed a physician pay rule that adds important details to the new, primary-physician-backed pay code for managing patients and that gives physicians more influence starting in 2016 over Medicare pay rates. Primary physicians are not paid for many services they provide, said Reid Blackwelder, president of the American Academy of Family Physicians, so CMS last year established a code that pays primary care physicians for managing beneficiaries with at least two chronic conditions.

FDA Drafts New Five-Year Priority Document

FDA Drafts New Five-Year Priority Document-thegraysheet: FDA’s proposed a new five-year strategic priorities plan has many similarities to last time the agency set such an agenda to paper in 2011, but it introduces some new concepts for its cross-cutting priorities and reorganizes its goal-setting approach, with more explicit attention to device postmarket surveillance, for instance. The 2014-2018 draft plan, issued June 30, retains the basic concepts of regulatory science, globalization and safety/quality enforcement as cross-cutting priorities. It highlights two new top-line agenda items: so-called smart regulation, which means balancing protecting the public with encouraging innovation, and stewardship, which reflects the increasingly challenged fiscal environment that FDA is contending with.