Small business owners aiming to unseat incumbents in midterms, poll shows

Small business owners aiming to unseat incumbents in midterms, poll shows-washingtonpost-Roughly four in five small business owners in states with elections coming up in November say they plan to vote, and among them, four in five are planning to cast their ballot for a challenger, according to a poll released Tuesday by online small business directory Manta.

Federal deficit narrows, CBO says, but bigger gap coming

Federal deficit narrows, CBO says, but bigger gap coming-politico: The federal deficit will narrow this year and next, new data from the Congressional Budget Office shows, but federal debt is expected to climb again in the latter part of the decade as tax receipts fall and spending on retirement and health care programs rise. Revised data released on Wednesday showed that the projected shortfall this year will be $506 billion rather than the $492 billion the nonpartisan group predicted in April, but still $170 billion smaller than the deficit in 2013.

Drug Firms Say They Properly Submitted Doctor-Pay Data That CMS Removed | InsideHealthPolicy.com

Drug Firms Say They Properly Submitted Doctor-Pay Data That CMS Removed | InsideHealthPolicy.com: "The brand drug lobby's top lawyer says pharmaceutical companies correctly submitted physician-pay information that CMS withheld from the Open Payments website and wants the agency to explain why it removed one-third of the records last month after initially blaming industry for improper submissions."

Lawmakers Continue Press For Medical Innovation Reforms During Recess | InsideHealthPolicy.com

Lawmakers Continue Press For Medical Innovation Reforms During Recess | InsideHealthPolicy.com: "As the August congressional recess draws to a close, a slew of House lawmakers within and beyond the Energy and Commerce Committee are drawing ideas from local constituents and key officials about medical innovation that could be included in discussions for the House 21st Century Cures Initiative."

HELP Committee Unveils Draft Proposing Sunscreen, OTC Review Timelines

HELP Committee Unveils Draft Proposing Sunscreen, OTC Review Timelines-insidehealthpolicy: Top lawmakers on the Senate health committee Friday (Aug. 22) unveiled a discussion draft bill that would streamline FDA's evaluation of sunscreen ingredients by establishing a timeline for reviews and also push the agency to establish timelines for other over-the-counter ingredients. The draft builds on the House-passed Sunscreen Innovation Act by adding OTC reforms. Sens. Tom Harkin (D-IA), Lamar Alexander (R-TN), Jack Reed (D-RI) and Johnny Isakson (R-GA) back the draft bill and are seeking public comment. The Senate discussion draft would clear a backlog of sunscreen ingredient submissions within eight months and require FDA review new submissions within an 11-month timeframe, which is included in the House-passed bill.

71 Doctor Groups Urge CMS To Delay Pay Code Changes By One Year

71 Doctor Groups Urge CMS To Delay Pay Code Changes By One Year-insidehealthpolicy:  CMS should push back by one year its proposed schedule for changing Medicare pay codes for physician services, 71 medical societies tell CMS, and they have a proposal to align the schedules of AMA's CPT Editorial Panel and the its Specialty Society Relative Vale Scale Update Committee (RUC). The letter was spearheaded by the American Medical Association, but it includes physician groups such as the American Academy of Family Physicians that have opposed the RUC for favoring specialists over primary care doctors.

Target Women’s Clinics, Keep Recruitment Open To Get More Women Into Trials, FDA Says In Guidance

Target Women’s Clinics, Keep Recruitment Open To Get More Women Into Trials, FDA Says In Guidance-thegraysheet: To get more women to participate in device clinical trials, companies should target women’s clinics for recruitment opportunities and plan focused efforts to enroll females under a continued access study. Those are two of multiple strategies FDA recommends in a final guidance (PDF) on parsing sex-specific clinical data. Adequate and appropriate populations of women are needed in clinical trials to support 510(k) clearances and PMAs, the agency notes.

Medical boards engage in telemedicine reform

Medical boards engage in telemedicine reform-politico: The increase in the use of telemedicine has been undeniable. Myriad companies — Doctor on Demand, Teladoc and American Well — now promise to connect patients directly to doctors through their phones. Employers and payers increasingly offer telemedicine as a way to reduce unnecessary emergency department visits and hospitalizations. Furthermore, more traditional providers like hospitals use the technology to extend the reach of hard-to-find doctors to remote patients.

FDA pilot program for medical device review tool development in the works

FDA pilot program for medical device review tool development in the works-massdevice: A new pilot program planned by the US Food and Drug Administration is being planned to develop tools for more effective and efficient reviews of medical device premarket applications. According to new guidance, the agency will begin seeking participants for its Medical Device Development Tools (MDDT) Pilot Program in September 2014. Qualified MDDT program participants would develop tools for use by both regulators and manufacturers to evaluate performance, safety and effectiveness of devices before and during their US premarket registrations.

Report: The IRS is having trouble with the medical device tax

Report: The IRS is having trouble with the medical device tax-massdevice: Not even the IRS can make sense of the medical device tax, a provision of the Affordable Care Act requiring medical device companies to pay a 2.3% levy on all U.S. sales, according to a report from a U.S. Treasury inspector general.The tax is imposed on all U.S. sales of prescribed medical devices and contains a "retail exemption" on devices sold to the general public, such as contact lenses or diabetes devices and supplies. Estimates on the amount the tax is expected to range vary, from $30 billion over 10 years to the Joint Committee on Taxation's forecast for
$20 billion for fiscal years 2013 through 2019.

Hospitals, Seniors Advocates Advise Expanding Data Transparency To MA, Part D

Hospitals, Seniors Advocates Advise Expanding Data Transparency To MA, Part D-insidehealthpolicy: Hospitals and seniors advocates are using Finance Committee senators' request for advice on health care data transparency to get more information on Medicare Advantage and Part D. Hospitals used the occasion to tout legislation to help consumers understand their out-of-pocket costs. Senate Finance Chair Ron Wyden (D-OR) and committee member Charles Grassley (R-IA) requested advice for improving data transparency in June.

FDA Abandons “Pre-Decisional” IDE Proposal

FDA Abandons “Pre-Decisional” IDE Proposal-thegraysheet: FDA has dropped current plans for establishing a specialized interactive review process for investigational device exemption submissions. The agency posted a final guidance on FDA decisions for IDE submissions (PDF) Aug. 18, following up on a June 2013 draft document. In the draft, FDA had proposed a new “pre-decisional” IDE review process, which FDA hoped would help companies maximize the chance of gaining IDE approval for a study that also has a good chance of eventually supporting marketing clearance or approval.

PCORI dangles $90M in grants for comparative effectiveness research

PCORI dangles $90M in grants for comparative effectiveness research-massdevice: The Patient-Centered Outcomes Research Institute is looking to dole out $90 million in support for clinical research, the organization announced today. PCORI is looking for studies that will highlight practical questions in healthcare in order to help patients, doctors and other healthcare stakeholders make more informed decisions. Called "comparative effectiveness research," the studies aim to compare drugs, surgery, devices and other medical options based on their relative benefits and risks.

Sunshine Act follies spark more concern | MassDevice.com On Call

Sunshine Act follies spark more concern-massdevice: MASSDEVICE ON CALL — Physicians' groups are up in arms about the looming launch of the a public database of industry-doctor relationships, citing concerns about errors in reporting and security breaches that appear to muddle the program's credibility. The public database, scheduled to go live September 30, will allow anyone with interest to peruse troves of data about the financial exchanges between doctors and manufacturers of drugs and medical devices, but the novel program has its share of issues.

China calls for greater use of homegrown medical devices

China calls for greater use of homegrown medical devices-reuters: (Reuters) - China may use incentives to encourage domestic hospitals to use Chinese-made medical devices as it looks to stimulate the local market and reduce soaring healthcare costs, a potential threat to the global firms who currently dominate the sector.

CMS Sticks With Sept. 30 Launch For Open Payments, But Not All Data Will Be There

CMS Sticks With Sept. 30 Launch For Open Payments, But Not All Data Will Be There-thegraysheet: CMS says 2013 data on device and drug firm payments to physicians and teaching hospitals will still go online Sept. 30 despite a 12-day delay in the registration and review process by providers. But the data posted Sept. 30 will only include about two-thirds of what manufacturers and group purchasing organizations have submitted to CMS, while the rest is delayed until next year due to data inconsistencies.

Docs perform 1st U.S. tricuspid valve replacement using TAVI device

Docs perform 1st U.S. tricuspid valve replacement using TAVI device-massdevice: MASSDEVICE ON CALL — Physicians at the Henry Ford Hospital in Detroit last month became the 1st in the U.S. to use a minimally invasive technique to replace a failing tricuspid valve. The team used a transcatheter aortic valve implant in the procedure, after the patient was turned down at 1 major medical center and doctors at another said her only option was a heart transplant.

US regulators to exempt some Class I and II medical devices from 510(k) premarket review

US regulators to exempt some Class I and II medical devices from 510(k) premarket review-massdevice: The US Food and Drug Administration plans to exempt certain medical devices from 510(k) premarket notification requirements due to what the agency considers their well-established safety and effectiveness.

Sunshine Law's Open Payments Website Back Online As Concerns Continue

Sunshine Law's Open Payments Website Back Online As Concerns Continue-insidehealthpolicy: The sunshine law's Open Payments system website came back online Thursday (Aug. 14) after CMS took the system down earlier this month, and CMS has pledged to extend the review and dispute deadline to compensate for the time the system was offline. Hours after the website was up and running a handful of doctors complained on Twitter that payments previously attributed to them were changed. Some stakeholders have said the problems with system -- compounded by other issues with the registration process -- could discourage some physicians from trying to participate in the program and affect the validity of the program's data. Others say the issue mirrors the problems healthcare.gov experienced when the site was first launched, and CMS should apply the lessons it learned from that experience when trying to move the program forward.

FDA Launches Pilot Program To Qualify Medical Device Development Tools

FDA Launches Pilot Program To Qualify Medical Device Development Tools-thegraysheet: FDA has launched a pilot program to help it develop the final guidance on qualifying medical device development tools (MDDT). The Aug. 15 document, titled “Pilot Program for Qualification of Medical Device Development Tools,” builds on FDA’s Nov. 2013 draft guidance for plans to improve the device approval process by creating a system for FDA to formally qualify development tools for any company to use. Experience with the MDDT pilot program will help inform FDA’s final guidance on the MDDT qualification processes, FDA explains.

VA referrals to private doctors on rise

VA referrals to private doctors on rise-politico: MEMPHIS, Tenn. — The Department of Veterans Affairs is significantly increasing its referrals of veterans to private doctors following a scandal over lengthy patient waiting times at many VA hospitals and clinics and falsified appointment records, VA Secretary Robert McDonald said Wednesday. McDonald spoke to a few hundred people at the American Veterans national convention. He is scheduled to visit the city's VA hospital on Thursday.

Depression, suicide and heart surgery

Depression, suicide and heart surgery-massdevice: MASSDEVICE ON CALL — Williams had surgery in 2009 at the Cleveland Clinic to repair his aortic and mitral valves and to treat abnormal heart rhythms, according to NY Daily News. Between 20-40% of heart surgery patients experience cardiac depression, American Heart Assn. and American Stroke Assn. spokesperson and cardiologist Dr. Tara Narula told the paper.

Pew Tells Senators UDI System Will Promote Health Data Sharing

Pew Tells Senators UDI System Will Promote Health Data Sharing-thegraysheet: In response to the Senate Finance Committee’s June 12 request for comments (Word Document) on ways to make health care data more useful and readily available, stakeholders behaved like characters in the “Blind Men and the Elephant” fable, i.e., each group commented on totally different aspects of data sharing issues. The Senators wrote: “Health care-related data, specifically, is a growing but largely untapped resource for accelerating improvements in health care quality and value.” The committee asked providers, patients, advocates, insurers and industry for new ideas to improve the overall transparency of the health care system. Comments were due Aug. 12.

China Will Expand Clinical Trial Requirements, Emphasizing Higher-Risk Devices

China Will Expand Clinical Trial Requirements, Emphasizing Higher-Risk Devices-thegraysheet: China FDA will officially require most Class 2 and Class 3 devices to conduct a clinical program in China to support regulatory approval starting in October under a new regulation. CFDA has previously issued regulations on conducting clinical trials for medical devices, but the new rule represents a more comprehensive approach to clinical trial requirements. Class 2 devices are categorized as those with relatively low risk while Class 3 products are implanted in the body or used to sustain or support life.

Tauzin: Path Needed For Cures That Spans Financing To Reimbursement

Tauzin: Path Needed For Cures That Spans Financing To Reimbursement-insidehealthpolicy: Tauzin says drug companies were already telling him that curative drugs would not fit into the current system when he was president and CEO of the Pharmaceutical Research and Manufacturers of America, a job he left in 2010. Critics of the pharmaceutical industry often charged that drug companies were only interested in inventing chronic treatments, he notes. That was a false accusation, he adds, and critics are now complaining about the cost of cures. He says drug companies have long realized it would be difficult to price cures once science got to that point because the system is designed for the long-term recovery of research and development costs. Cures eventually make drugs obsolete so drug companies must get their investments back earlier, he adds.

Benefits Of FDA's New Premarket Device Exemptions Not Clear, Attorneys Say

Benefits Of FDA's New Premarket Device Exemptions Not Clear, Attorneys Say-insidehealthpolicy: Industry attorneys said recent guidance announcing FDA's intention to exempt certain low-risk devices from premarket notification requirements could have limited benefits. One attorney said he initially saw the guidance as a "huge boost" to industry, especially mobile health manufacturers, but now believes the ambiguous guidance might not actually exempt as many products as expected.

Lab Groups’ LDT Comments Will Highlight Barriers To Test Accessibility

Lab Groups’ LDT Comments Will Highlight Barriers To Test Accessibility-thegraysheet: Clinical laboratory groups plan to focus their comments on FDA’s proposed regulatory framework for laboratory developed tests on the barriers to test access they say the new scheme will create. Representatives of some lab groups told “The Gray Sheet” in early August that they have already started to address FDA’s concerns about the clinical validity of the tests.

Developing new tools to support regulatory use of "Next Gen Sequencing" data

Developing new tools to support regulatory use of "Next Gen Sequencing" data-massdevice: NGS is a complicated technique, but basically it involves cutting the genome into millions of small pieces so you can use sophisticated chemical tricks and technologies to ignore the "junk" you don't need, and then make up to hundreds of copies of each of the pieces you want to study. This enables additional techniques to identify changes in the sequence of nucleic acids that might be mutations. NSG enables scientists to fast-track this process by analyzing millions of pieces of the genome at the same time. For comparison, the famous human genome sequencing and analysis program that took 13 years to complete and cost $3 billion could now be completed in days for a few thousand dollars.

'Conflict of interest' doctor database unplugged | TheHill

'Conflict of interest' doctor database unplugged | TheHill: "The Centers for Medicare and Medicaid Services (CMS) has pulled the plug on a new database intended to disclose potential conflicts of interest among physicians.

The agency’s Open Payments System lists payments from drug and medical device makers to doctors. It is supposed to go public on Sept. 30 after doctors have been given a chance to dispute any information on it by Aug. 2"

MRI Price Transparency Program Reduces Per Test Cost By $220, Study Says :: “The Gray Sheet”

MRI Price Transparency Program Reduces Per Test Cost By $220, Study Says :: “The Gray Sheet” : "Letting commercial insurance patients understand and choose among several providers of MRI tests reduces the per-test price by $220, and reduces the number of hospital-based MRIs, according to a study in Health Affairs."

Brady Seeks Feedback On Wide-Ranging Medicare Anti-Fraud Discussion Draft

Brady Seeks Feedback On Wide-Ranging Medicare Anti-Fraud Discussion Draft-insidehealthpolicy: House Ways & Means health subcommittee Chair Kevin Brady (R-TX) unveiled a discussion draft of the committee's anticipated wide-ranging bill to combat Medicare and Medicaid fraud that pulls ideas from a range of previously introduced bills, which Brady says could kick-start larger system changes. The discussion draft, floated Thursday (Aug. 7), is open for comment from stakeholders, and Brady says in a statement he hopes to get an anti-fraud bill passed on a bipartisan basis and signed into law this year. The goal is for the Protecting Integrity in Medicare Act to save money, but at minimum it needs to be budget neutral, Brady says.

AMA Asks For Six-Month Delay In Open Payments Data Release

AMA Asks For Six-Month Delay In Open Payments Data Release-thegraysheet: The American Medical Association wants CMS to delay the start of public reporting on financial transactions between medical product makers and physicians in its “Open Payments” database to allow time for doctors to fully grasp the registration process, and to correct any erroneous physician information supplied by manufacturers.

House Bill Would Tie Electronic Health Records To Clinical Registries :: “The Gray Sheet”

House Bill Would Tie Electronic Health Records To Clinical Registries :: “The Gray Sheet” "A clinical registries bill passed by the House Energy and Commerce Committee July 30 would call on HHS to recommend how to tie data from patients’ electronic health records into information collected from clinical trials, and on ways to use registries to capture postmarket device data and support device reimbursement."

New China FDA Device Regs Have Companies Scrambling To Comply

New China FDA Device Regs Have Companies Scrambling To Comply-thegraysheet: More than 10 regulations pending from China FDA will target most aspects of devices’ product life cycle, ranging from clinical study requirements, regulatory approval, manufacturing and quality assurance through to postmarket surveillance. The long-awaited rules will also provide details on the implementation of the Medical Device Administration Regulation, the first comprehensive regulation targeting medical devices in China in more than a decade.

Safety-net hospitals’ disproportionate share

Safety-net hospitals’ disproportionate share-politico: America’s Essential Hospitals, widely recognized as taking on a disproportionate amount of uncompensated care, are also doing a large share of trauma and psychiatric care and physician training, according to a report released Monday by the association. The group has 250 of the more than 5,700 hospitals in the country but provide about 17 percent of all uncompensated care, totaling $7.7 billion in 2012.