E&C Health Panel Aborts Markup Of Clinical-Registry, Physician-Oversight Bills | InsideHealthPolicy.com

E&C Health Panel Aborts Markup Of Clinical-Registry, Physician-Oversight Bills | InsideHealthPolicy.com: "The House Energy and Commerce health panel aborted a planned Monday (July 28) markup of two health care bills -- one calls for HHS proposals on clinical data registries and the other delays physician-oversight rules for small, rural hospitals -- but the full committee will take up both on Wednesday (July 29)

Adding UDIs To Claims Is Crucial for Device Surveillance, Pew Tells Congress

Adding UDIs To Claims Is Crucial for Device Surveillance, Pew Tells Congress-massdevice: Two years after Congress mandated in the FDA Safety and Innovation Act that the Sentinel Initiative be expanded to cover devices, there are still technical barriers to making that happen, Josh Rising, from The Pew Charitable Trusts, told a congressional subcommittee July 22. One of the biggest barriers, he said, is the lack of unique device identifiers on insurance claims forms.

Deal could lift U.S. medical device exports to China

Deal could lift U.S. medical device exports to China-politico: Medtronic and GE could be two of the big winners if China agrees to cut tariffs on high-tech medical devices as part of new trade agreement that could be concluded this year. But import duties are only one of many barriers restricting access to one of the world’s fast-growing healthcare markets. “I would say things are improving very quickly, but we’ve definitely still got a lot of challenges left to go,” said Elise Owen, an associate vice president in charge of China trade issues for the Advanced Medical Technologies Association. “Our companies encounter a lot of challenges getting product approved in the China market.”

Clinical Registries Need Streamlining To Reap Benefits, Mussallem Tells Congress :: “The Gray Sheet” :: Pharma & Medtech Business Intelligence

Clinical Registries Need Streamlining To Reap Benefits, Mussallem Tells Congress :: “The Gray Sheet” :: Pharma & Medtech Business Intelligence: "Clinical registries can yield useful information on patient outcomes that can support approval, reimbursement and care decisions but the benefits of registries need to be balanced against their costs, Edwards Lifesciences CEO Michael Mussalem told a House Energy and Commerce subcommittee July 22."

FDA’s Expedited PMA Pathway Proposal: To Expand Or Contain? :: Medical Device News from “The Gray Sheet” :: Pharma & Medtech Business Intelligence

FDA’s Expedited PMA Pathway Proposal: To Expand Or Contain? :: Medical Device News from “The Gray Sheet” :: Pharma & Medtech Business Intelligence: "As FDA moves to establish an accelerated development program for breakthrough devices, it is getting diverging input on how expansive the program should be. Industry insists that the agency is thinking too small, while others say FDA must take care to ensure the program is limited and tightly controlled."

Bill denying tax breaks for offshoring moves forward

Bill denying tax breaks for offshoring moves forward-politico: A bill denying companies tax breaks associated with moving jobs overseas advanced Wednesday in the Senate, as Democrats ramped up criticism of companies moving offshore to save on taxes. Somewhat surprisingly, Republicans joined Democrats in a 93-7 procedural vote to push forward a bill offering businesses a 20 percent tax credit for expenses associated with moving operations to the U.S. from abroad while simultaneously scotching deductions tied to moves in the other direction. Republicans had called the bill an election-year gimmick.

FDA 510(k) Risk-Benefit Guide Oversteps Regulatory Bounds, Attorney Says

FDA 510(k) Risk-Benefit Guide Oversteps Regulatory Bounds, Attorney Says-insidehealthpolicy: A device industry attorney says FDA may have overstepped its legal bounds with a new guidance document that she suggests applies the same benefit and risk standards for innovative devices to 510(k)s with technological differences from their predicates. The attorney, who previously worked for FDA's device center, says the policy is a fundamental reworking of the 510(k) review process, and questions if the agency had quietly implemented the policy prior to issuing the draft guidance. The guidance, however, says it neither changes the 510(k) premarket review standard nor requires more performance data from submitters of a 510(k).

Medicare's Sunshine Act changes could hit device makers in the pocketbook

Medicare's Sunshine Act changes could hit device makers in the pocketbook-massdevice: Medicare regulators are looking for feedback on proposed changes to the laws governing transparency in financial relationships between doctors and healthcare companies, warning that the changes may represent a hefty new cost for medical device makers in particular.

What if McConnell loses?

What if McConnell loses?-politico: It’s a taboo subject among Senate Republicans but one that’s on many senators’ minds: What if Mitch McConnell loses his reelection bid? There appears to be no clear answer to that question, at least not right now. In interviews and private conversations with more than half of the 45-member Senate Republican Conference, there is a split over a potential McConnell successor, a sign that there could be an opening for a new GOP leader should Democrats pull off an upset in the Kentucky Senate race.

Indian regulators clarify requirements for medical device registrations, clinical trials

Indian regulators clarify requirements for medical device registrations, clinical trials-massdevice: New orders from the Indian Ministry of Health & Family Welfare's Central Drugs Standard Control Organization (CDSCO) clarify some requirements regarding the country's sometimes opaque medical device registration and clinical trial regulations.

US FDA publishes insight into 510(k) Substantial Equivalence determination process

US FDA publishes insight into 510(k) Substantial Equivalence determination process-massdevice: New draft guidance from the US Food and Drug Administration lays out major factors the agency considers when reviewing 510(k) premarket notification applications to make Substantial Equivalence (SE) determinations. US regulators have issued the new guidance to serve both as a resource for agency reviewers making SE determinations and as a tool for 510(k) applicants to more effectively demonstrate equivalence to predicate devices already on the US market.

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.

CMS Proposes Changes To Industry Sunshine Act Disclosure Rules

CMS Proposes Changes To Industry Sunshine Act Disclosure Rules-thegraysheet: Device firms would be required to report the brand name of products as part of payment disclosures to CMS’ Open Payment database under revisions to the disclosure requirements proposed July 3. Further, under the proposed revisions, payments made to speakers at certain continuing medical education events would no longer be exempt from disclosure to the public database.

The Crazy Way the Government Buys Billions of Dollars of Drugs - Businessweek

The Crazy Way the Government Buys Billions of Dollars of Drugs - Businessweek: "The government pays vastly different prices for medicines depending on which office is buying them, according to a new report (PDF) from the Government Accountability Office."

FDA aims to stay the course in new 4-year plan

FDA aims to stay the course in new 4-year plan-massdevice: The FDA today revealed a draft version of its 4-year plan, laying out strategic priorities and goals for keeping patients and consumers safe while addressing industry concerns. The agency highlighted 5 primary areas of concern: regulatory science, globalization, safety & quality, smart regulation and stewardship. Regulators plan to focus on these areas over the next 4 years in order to help speed innovations to market, provide the public with the best health information and ensure the security of regulated products.

What a Republican Senate Majority May Mean for ObamaCare | Morning Consult

What a Republican Senate Majority May Mean for ObamaCare | Morning Consult: "This much, we know: if Republicans regain both houses in January 2015, health policy in the 114th Congress will be dominated by a showdown between a Republican Congress and a Democratic White House over the future of Obamacare. The challenge for Republicans will be how to balance the desire of the party faithful for repealing Obamacare with the reality that President Obama would never permit it under his watch."

Reforming the VA one step at a time

Reforming the VA one step at a time-politico: Congress is poised to pass the most significant reforms to the Department of Veterans Affairs in nearly two decades — but don’t expect quick fixes to the layers of rot at the agency. The House and Senate have passed bills responding to revelations that veterans died after the VA delayed providing medical care. But the measures don’t change the VA employees’ habit of gaming the system, covering up problems and punishing whistleblowers who try to sound the alarm — the “corrosive culture” that White House deputy chief of staff Rob Nabors warned about in a report to President Barack Obama last week.

Senators Ask CMS To Allow Public Input When Setting Doctor Pay Rates

Senators Ask CMS To Allow Public Input When Setting Doctor Pay Rates-insidehealthpolicy: Piggybacking on a bipartisan House request, a dozen senators are urging CMS to make public the process of setting values for physician services, which would take away some of the influence the American Medical Association's RUC has over billing codes. CMS is poised to propose the 2015 Physician Fee Schedule, and lawmakers complain the agency traditionally has waited until the final version of that annual rule to include revised values for physician services, shutting out public comment on the RUC-driven values. "We respectfully request that you strongly consider revising the current process by publishing these reimbursement changes to existing codes in the annual physician fee schedule proposed rule," the senators write.

Waste, errors in health care remain huge issues, experts agree

Waste, errors in health care remain huge issues, experts agree-politico: Despite health care industry concerns about wasteful and unnecessary care, it’s nearly impossible for patients to overrule their doctors when they think they’re getting a procedure they don’t need, a prominent patient care advocate argued Tuesday. “I’ve had four unnecessary EKGs,” Daniel Wolfson, executive vice president of the ABIM Foundation, said at a POLITICO Pro Health Care breakfast briefing at the Newseum. “I think it’s an uphill battle for the patient to talk a physician out of a procedure.”