FDA and Bayer Essure Asked to Explain: 303 Fetal Deaths and Kickbacks

FITZPATRICK QUESTIONS FDA OVER ESSURE DATA, ALLEGED KICKBACKS

Jeffrey Shuren, M.D., J.D.

Director, Center for Devices and Radiological Health

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

February 16, 2016

Dear Dr. Shuren,

As you are aware, thousands of women have filed formal complaints to the Food and Drug Administration regarding the permanent contraceptive device Essure. These injured women have reported numerous symptoms related to this FDA-approved device, such as extreme pelvic pain, allergic and immunological reactions, heavy bleeding, unexplained weight gain, loss of teeth and hair, and broken coils migrating throughout their body and puncturing internal organs.

Tragically, this device has also killed innocent women and unborn children. The FDA’s public materials related to Essure have cited five reports of fetal deaths.

However, my office is in receipt of a review of adverse event reports related to Essure, conducted by women harmed by this device and an adverse event data expert. This independent report counts 303 fetal deaths. A copy of this report is enclosed.

In light of this immense discrepancy, I request that the FDA conduct a thorough review of this document and all of the adverse event reports received by those harmed by Essure as part of FDA’s on-going review of this medical device.

Additionally, my office is in receipt of an unsealed complaint filed in the U.S. District Court for the Northern District of California which named the United States of America, 27 States, and the District of Columbia as plaintiffs against Conceptus, Inc., Bayer AG, Inc. and Bayer Healthcare, LLC. A copy of the complaint is enclosed.

The complaint alleges that the manufacturer of Essure gave substantial and illegal financial inducements to providers to encourage them to use Essure, a procedure that costs the government almost $3,500 per patient.

According to the complaint, the manufacturer of Essure provided illegal kickbacks in the form of free medical equipment valued at $20,000. Additionally, the complaint alleges that the manufacturer of Essure would set up “referral lunches” to generate business by connecting primary care physicians and Ob/Gyns to create what the manufacturer called “coin-operated doctors,” designed to lead to the increased use of Essure. Furthermore, the manufacturer provided free marketing and advertising services to Ob/Gyns to encourage them to use Essure on their patients.

These alleged illegal kickbacks cost the taxpayers millions of dollars due to false claims against government healthcare programs such as Medicare, Medicaid and Tricare.

In addition to the review of 303 fetal death reports, I request that the allegations of illegal kickbacks filed against the Essure manufacturer also be included as part of the review being conducted by the FDA.

Sincerely,

Mike Fitzpatrick

Member of Congress

http://www.modernhealthcare.com/article/20160217/NEWS/160219918/congressman-says-fda-grossly-underestimated-harm-of-permanent#comments

http://bit.ly/1PRfMor

Congressman says FDA grossly underestimated harm of permanent contraceptive Essure

By Shannon Muchmore  | February 17, 2016

A U.S. congressman and a patient advocacy group said Wednesday a permanent contraception device linked to thousands of adverse events has led to far more fetal deaths than previously reported and that doctors performing the procedure received illegal kickbacks.

Rep. Mike Fitzpatrick (R-Pa.) said in a conference call with reporters that he found it troubling that the U.S. Food and Drug Administration did not act on the complaints it had received until thousands of women who said they had been harmed by the device started publicly announcing their concerns.

“They came together as a group frankly because nobody would believe them, not even their own doctors,” he said.

Madris Tomes, a medical-device reporting expert with Device Events, said she searched publicly available FDA data to find 303 reports of fetal deaths, a stark contrast to the five previously reported by the FDA, the agency responsible for evaluating the device's safety and usefulness.

The FDA was not immediately available for comment.

Fitzpatrick also discussed a complaint filed in the U.S. District Court for the Northern District of California that alleges doctors received $20,000 of free medical equipment for agreeing to buy 25 Essure kits.

The complaint also states that manufacturer sales representatives would organize lunches with primary-care providers and OB-GYNs, to generate more referrals to the OB-GYNs who produced the most revenue and advertised the most. The sales team internally referred to such providers as “coin-operated doctors.”

Fitzpatrick said he is coming forward with the information before the FDA is expected to release new guidance on the use of Essure later this month so that the agency can take it into account.

Essure can be installed by a doctor at a regular office visit lasting less than an hour. A small, flexible coil is inserted into each fallopian tube, causing scar tissue to form and block eggs from getting into the uterus.

The FDA approved the procedure in 2002 and Bayer bought the device from Conceptus in 2013. Some women who had the device implanted, however, said they suffered from intense pain and heavy bleeding. Complaints also included fetal deaths and uterine perforation.

The FDA issued an alert in June after a search of its Manufacturer and Use Facility Device Experience Database found more than 5,000 adverse-event reports. 

In September, the FDA Obstetrics and Gynecology Devices panel said use of Essure should be limited because not enough research has been performed to prove it is safe. The panel took no formal vote, however, and did not take the product off the market as many advocates had requested.

Fitzpatrick, who has introduced a bill requiring the FDA to pull its approval of Essure, sent a letter this week to the director of the FDA Center for Devices and Radiological Health, outlining the findings and requesting an immediate review.

FDA Approved Medical Device Being Blamed For Countless Injuries, Medical Conditions

February 17, 2016 1:51 PM By Mike Dougherty

http://philadelphia.cbslocal.com/2016/02/17/thousands-push-for-medical-device-linked-to-fetal-deaths-taken-off-market/#comments

PHILADELPHIA (CBS) — Congressman Mike Fitzpatrick is calling for the Food and Drug Administration to ban the use of a medical device that’s been the source of tens of thousands of complaints.

Bayer Essure is implanted into the fallopian tubes for permanent sterilization, but women are reporting widespread complications and even death.

Essure has an FDA gold stamp of approval, but Congressman Fitzpatrick says it’s responsible for more than 300 fetal deaths and countless other medical complications.

It goes deeper. Fitzpatrick says kickbacks from Bayer, the manufacturer provided illegal financial incentive to doctors.

“The manufacturer is providing free marketing and advertising services to OB/Gyn. They were encouraging them to use Essure on their patients, and they were making a lot of money.”

Fitzpatrick says money from insurance companies, tax payers and women like Amanda Dikeman, who went through years of pain and suffering before the device was removed.

“My once very thick hair began falling out in clumps. I battled continuous urinary tract and kidney infections.”

Lawmakers want to know why it took so long for the FDA to receive patient complaints and why nothing has been done about them.

http://philadelphia.cbslocal.com/2016/02/17/thousands-push-for-medical-device-linked-to-fetal-deaths-taken-off-market/#comments

Women Want Bayer Essure Taken Off Market

Essure is a medical device that gets surgically inserted into a woman's fallopian tubes. It's marketed as a form of permanent sterilization for women, but it's been linked to more than 300 fetal deaths, and a group of 27,000 women on Facebook want to see it taken off the market. KYW's Mike Dougherty reports.

Mike Dougherty  Mike is a general assignment reporter and editor for KYW Newsradio 1060. His career at 1060 began as a desk assistant in January '07. A short nine months later, he was promoted to AM Drive writer while still studying broadcast journalism at Temple...

Medical Implants are SEXY (and profitable)! FDA and Bad Ads.

No consistency for handling misleading health ads

By Sabriya Rice  | August 19, 2015

Since it launched in 2010, the U.S. Food and Drug Administration's “Bad Ad” campaign has received hundreds of complaints about potentially misleading or imbalanced drug advertisements.

Most recently it condemned a series of social media posts by reality TV star Kim Kardashian, in which she raved about relieving morning sickness with a pill she endorses.

But while drug marketing is subject to “Bad Ad” oversight, watchdog groups, clinicians and policy leaders say there's far less scrutiny for medical devices and other health services.

Modern Healthcare recently spotted an ad on the back of a bus in downtown Chicago that could be a good example.

“Diets don't work, get a lap band,” is the message from Dr. Fredrick Tiesenga, a surgeon with the Elmwood Park, Ill.-based weight-loss surgical center, New Hope.

Tiesenga supports the claims. Diets have about a 5% success rate for morbidly obese people, he said. “That's the same as the number of people who think Elvis is still alive. It's not really evidenced-based medicine to continue to send those people to dietitians.”

Though Tiesenga says the ad is intended for people with extremely high body mass indexes who have tried and failed multiple diets, others say the average observer wouldn't know that just by looking at the ad.

“It's misleading. He's making a definitive statement that diets don't work, which we know is not true. And it doesn't include any qualifiers,” said Dr. Bruce Lee, director of the Global Obesity Prevention Center in the Johns Hopkins School of Public Health.

Behavioral modifications, including dietary changes, are a major part of success after bariatric procedures, which cost, on average, between $20,000 and $25,000 in the U.S.

The worry is that those who are struggling with weight loss, upon seeing a message such as that might feel validated to ditch the diet, thinking they can eventually opt for surgery. “It's a very strong statement,” Lee said. “When I see an ad like that, I'm concerned about what the impact might be.”

Experts say misleading health information can be propagated as federal agencies continue to struggle with both the ability to monitor the deluge of ads and identify what counts as an advertisement.

The issue is not only complicated for federal regulators, but also for patients, said Dr. Yael Schenker, an assistant professor of medicine at the University of Pittsburgh. She coauthored a 2014 report in the American Journal of Bioethics that evaluated the ethics of advertising healthcare services.

“It's hard for people to figure out what is truthful,” she said. “It's very easy to mislead the public about something like healthcare where there is an imbalance in terms of access to information.”

To date, the FDA has received nearly 800 complaints through its Bad Ad campaign. It did not say specifically how many of those complaints ended in warning letters or corrective actions such as civil monetary penalties, injunctions and referrals for criminal investigation.

An FDA spokesperson said: "We don't track this metric, as the goal of the program is to raise awareness of misleading advertising and not to increase enforcement actions."

The FDA says complaints about medical devices are forwarded to the Center for Devices and Radiological Health, which enforces violations against federal ad regulations. The Federal Trade Commission may also take actions separately based upon its own jurisdiction.

But the article last year from Schenker and colleagues urged that without consistent oversight and standards, ads for general healthcare services continue to play on emotional, fear-evoking appeals that don't provide specific information about risks, benefits and costs.

Developing and enforcing new standards will not be easy, but the current health environment contributes to “an incoherent status quo,” they said, one where the industry is working to create high-quality medical systems while competing with marketing messages that might encourage patients to seek unnecessary care and dump clinicians who refuse to give it to them.

“We have to accept that advertisements are intended to be persuasive and are never going to present a complete or exhaustive list of risks or benefits,” Schenker said. “But there needs to be a unique set of criteria and oversight that is different from cars or cereal and other run-of-the-mill consumer products.”

For Michael Carome, director of the Health Research Group at the watchdog organization Public Citizen, the differences in advertising reflect a broader concern about pre-market FDA approvals, which are also different for drugs and devices. “The standards are much lower for devices than for drugs,” he said. “That dichotomy extends to advertising provisions.”
http://www.modernhealthcare.com/article/20150819/NEWS/150819898/no-consistency-for-handling-misleading-health-ads

Criminal Fraud Prosecutions of Healthcare Corporations and Executives May Increase

Tenet probe shows feds' growing interest in criminal fraud cases 

By Lisa Schencker  | May 14, 2015  (FiDA highlight)

The U.S. Justice Department has launched a criminal investigation into previously disclosed allegations that Tenet Healthcare Corp. hospitals paid kickbacks for maternity referrals. The probe reflects a growing appetite among prosecutors to pursue criminal charges in corporate healthcare fraud cases. 

Tenet spokesman Donn Walker declined to comment on the issue, saying only, “We have disclosed this investigation in our public filings for some time.”

In a filing to the Securities and Exchange Commission this month, Tenet said four of its hospitals in Georgia and South Carolina are under criminal investigation related to a whistle-blower lawsuit filed in 2009. 

The Justice Department, meanwhile, recently adopted a procedure that ensures that its Civil Division shares all new whistle-blower complaints with its Criminal Division to allow the department to conduct parallel investigations. 

In Tenet's case, the civil complaint alleges that the hospitals paid kickbacks to a company called Hispanic Medical Management to send them pregnant women from the company's prenatal clinics to deliver their babies. Those patients—most of whom, according to the complaint, were in the country illegally—would then be eligible for emergency Medicaid services. 

The government also alleged the hospitals included those patients obtained from tainted referrals when seeking additional Medicare funds intended to support hospitals that treat large numbers of low-income patients. 

Tenet has countered in court documents that its hospitals' contracts with Hispanic Medical Management were meant to “create a culturally sensitive and attractive prenatal environment for women” who might deliver their babies at the hospitals. 

The management company provided translators and community outreach and helped families apply for emergency Medicaid coverage, according to Tenet. The government's allegations “rest on the hospitals' open desire to care for a deserving, but underserved population and the attractive solution they designed to do so,” the company said. 

Two individuals—a former Hispanic Medical Management owner and a former employee of one of the Tenet hospitals—have been charged criminally in the matter. The civil suit has been put on hold pending further proceedings in the criminal case, according to Tenet's SEC filing.

Tenet said the Justice Department informed the company on April 10 that the four hospitals named in the civil suit are also under criminal investigation. Those hospitals are Atlanta Medical Center; Hilton Head (S.C.) Hospital; North Fulton Hospital, Roswell, Ga.; and Spalding Regional Medical Center, Griffin, Ga.

Criminal investigations and charges in big Medicare and Medicaid fraud cases are becoming increasingly common, said Sheryl Skolnick, director of research and a healthcare analyst at Mizuho Securities USA. Historically, criminal prosecution was more common in smaller Medicare and Medicaid fraud cases, she said. It's more difficult to bring criminal charges because the standard of proof is higher than in civil cases.

“You have to prove intent, which at a corporate level means you have to have some level of senior management involved and some sort of pattern that you can essentially say this was not just a fluke of a one-off situation but rather this was part of a strategy or policy or intent of the organization to bill in this way,” Skolnick said.

But the Justice Department now seems to be extending those criminal investigations to large, publicly traded corporations, she said. “It was pretty much just a matter of time before they would move up the chain now that they have some success under their belt—see what's cooking at the corporate level." 

Leslie Caldwell, the Justice Department's assistant attorney general for the Criminal Division, said as much during an address in September 2014 when she called whistle-blower cases “a vital part of the Criminal Division's future efforts.”

Caldwell reiterated the division's commitment to fraud cases, including those by healthcare executives, during remarks Thursday at the American Bar Association's 25th Annual National Institute on Health Care Fraud.

Under a new policy, she said, all new whistle-blower complaints in the Civil Division are shared with her division. “Parallel investigations maximize the department's ability to secure the appropriate outcome in each matter—whether it be financial penalties, restitution, federal program exclusion or criminal prosecution of both corporations and individuals,” Caldwell said Thursday.

Caldwell pointed to convictions against more than 20 individuals in a fraud case against the American Therapeutic Corp. as an example of a recent complex criminal healthcare fraud case.

Patrick Burns, co-director of the Taxpayers Against Fraud Education Fund, a not-for-profit organization partly funded by whistle-blowers and law firms representing them, said prosecutors are seeking to maximize the financial returns for the government in large cases, especially as the recovery amounts climb. 

Whistle-blowers are entitled to a portion of whatever money the government is able to recover under the False Claims Act. That's not true in criminal cases. 

“As the amount of money has gone up, the Department of Justice has looked for a way to manage down whistle-blower awards,” Burns said.

Burns said he doesn't believe the approach has been much of a deterrent because the Justice Department rarely holds individuals accountable for the fraud by excluding them from Medicare and Medicaid and sending them to prison.

“Yes, we need to recover America's stolen billions but we also need to bring personal pain to the executives who design, operationalize and greenlight these massive frauds,” Burns said.

But Skolnick said the rise in criminal investigations means companies must be “increasingly vigilant." 

In a separate matter, Tenet also disclosed this month that it is in discussions with the Justice Department over a potential settlement involving its use of implantable defibrillators at 56 hospitals from 2002 to 2010. 

The government has spent years investigating suspected overuse of the devices at hospitals across the country. The investigation has yielded settlements with just a few hospitals so far: Irvine, Calif.-based St. Joseph Health; the now defunct MedCath; and Catholic Health Initiatives. None of those companies admitted liability as part of their settlements.

The investigation has been controversial among doctors, who say Medicare's coverage rules for the devices are not aligned with other medical guidelines.

http://www.modernhealthcare.com/article/20150514/NEWS/150519933?utm_source=modernhealthcare&utm_medium=email&utm_content=externalURL&utm_campaign=am

Lisa Schencker

Lisa Schencker

Lisa Schencker covers legal issues and enforcement agencies. Before joining Modern Healthcare in 2014, she was an education reporter for the Salt Lake Tribune and before that wrote for the Bakersfield Californian and the Scranton (Pa.) Times-Tribune. She has bachelor’s and master’s degrees in journalism from the University of Illinois at Urbana-Champaign.

"PROVE IT !!!" M-o-M hips, pelvic surgical mesh, Essure birth control . . .

Health officials tell medical technology group to'prove it'

By Sabriya Rice

Posted: October 8, 2014 - 3:15 pm ET

Tags: Costs, Medical Devices, Medical Technology, Quality

“Prove it.” That was the resounding message to medical-device manufacturers during the annual Advanced Medical Technology Association conference in Chicago this week. Innovation is needed to advance medicine and better patients' quality of life, but gone are the days of sticking higher price tags on products that only provide incremental improvements, the leaders of health insurance companies, health systems, quality improvement and consumer organizations told the industry.

“We don't want to squelch innovation,” said Dr. Scott Josephs, national medical officer for the health insurance provider Cigna Corp. “But tell me what I'm getting for my healthcare costs. Show me that these new technologies are superior,” he told the audience during a session Wednesday morning.

Related Content

Payment reform puts medical-device industry on the defensive

Josephs was joined on the panel by Susan DeVore, president and CEO of the health improvement organization and group purchasing organization Premier; and Mark Neaman, CEO of the Chicago area's NorthShore University HealthSystem. An essential element in the aim for higher efficiency will be the need to more critically assess the value of new innovations, the panelists said.

“If it's clinically appropriate but equally efficacious to existing technology, then frankly it's just adding costs to the system,” Josephs said. “That's not something we would prefer.”

Fee for service is dead and the current landscape “is a bit chaotic,” noted DeVore, who said health providers are in the process of integrating what has been a fragmented industry. In light of that, the old ways of doing things are not going to suffice, Neaman said. “The stakes are very high for us as providers,” he told the audience.

New payment models aimed at improving efficiency and getting a handle on costs have proliferated quickly in recent years, nurtured by provisions of the Patient Protection and Affordable Care Act. Many providers are joining accountable care organizations, which are risk-sharing mechanisms available through government payers like Medicare as well as private payers, in which members agree to strive for cost and quality targets and share savings or losses.

Monday, AdvaMed promoted an industry-funded white paper based on the responses of officials from nine unnamed health insurance companies who were interviewed about their movement toward pay-for-performance and risk-based contracts. Officials from five insurers said they had become more selective about approving coverage for new technologies in the past three years. Four said they plan to demand more evidence before covering products. All said costs were driving their organizations to explore new reimbursement models.

The trade group representing medical-device manufacturers worried these rapidly burgeoning pay-for-performance and risk-based reimbursement models will result in what AdvaMed CEO Stephen Ubl called “unintended consequences.”

Too many of the arrangements emphasize cost targets over quality benchmarks, said Joe Almeida, the trade group's chairman as well as CEO of the medical-device manufacturer Covidien. “They run the risk of really tipping too far, so physicians have incentive not to adopt things that really benefit patients,” said David Nexon, an AdvaMed senior vice president.

Health economists countered that the white paper may have overstated those concerns and that it's hard to make the extrapolation. Insurers agreed, saying truly superior innovations would not be overlooked, even if they come at higher costs. And most health officials interviewed by Modern Healthcare said the key factor is the proof.

“The thing that's been missing from the model until now is the evidence,” said Diana Zuckerman, a researcher who has been critical of the Food and Drug Administration's procedures for approving and monitoring medical devices.

The federal agency's recent plans for an accelerated approval pathway for some medical devices has been met with criticism by consumer advocates who say such efforts put patients in danger.

During a conference session on Tuesday afternoon, FDA Commissioner Dr. Margaret Hamburg said that as science and technology advance at extraordinary rates, the agency wants to stay up to speed as a partner with the medical technology community. A more efficient system overall will allow for the delivery of new science and technology for patients in more reliable and cost-effective ways, but the emphasis on speed doesn't mean a step away from scientific rigor, she said.

As new products make their way to the forefront, no matter how rapidly, the onus is increasing for manufacturers to ensure that providers are convinced the innovations are worth the financial investment.

It's not about the lowest price point, that's just one part of the overall value equation, Cigna's Josephs said. It's about having more data and conceiving of partnership arrangements to help get there, according to Premier's DeVore. “Bring your evidence and data, and bring a willingness to collaborate and take risks,” she said.

Follow Sabriya Rice on Twitter: @MHsrice

Buy! Buy! Medical Device Indu$try Consolidate$/Invert$: Follow the Money

FiDA highlight

Sunshine on medical-device makers: Five give $56.7million

By John N. Frank   

Posted: October 2, 2014 - 1:45 pm ET

Device maker payments to providers

Aug. 1, 2013-Dec. 31, 2013

Device maker	Payment
Zimmer*	$17,428,680.83
Medtronic*	$13,024,707.80
Boston Scientific Corp.*	$8,882,851.72
Stryker Corp.	$8,742,778.75
Intuitive Surgical	$8,638,153.40

Created with Datawrapper

Source: Modern Healthcare analysis of CMS’ Open Payments website Get the data

Five prominent medical-device makers gave a total of $56.7 million to doctors and teaching hospitals from Aug. 1-Dec. 31, 2013, for research and general purposes, according to a Modern Healthcare analysis of data posted on the new Open Payments website.

Leading the list of devicemakers is Warsaw, Ind.-based Zimmer, which gave $17.4 million, followed by Minneapolis-based Medtronic, which gave $13 million. Medtronic competitor Boston Scientific gave $8.8 million.

Competition among devicemakers has been intense, and the companies have been pursuing mergers and acquisitions and new contract models with providers, which view high-cost supplies as an area to cut costs. Zimmer, which makes orthopedic reconstructive, spinal and trauma devices, dental implants and related surgical products, is pursuing a $13.35 billion acquisition of competing orthopedic manufacturer Biomet. Medtronic announced plans to buy surgical supplier Covidien for $42.9 billion as the sector continues to consolidate.

The data were published on the Open Payments website, which was required by the Physician Payments Sunshine Act, a provision of the Patient Protection and Affordable Care.

*Zimmer recently purchased Biomet:  the only manufacturer that provided patients a warranty on product. 

*Medtronics will  avoid paying U.S. taxes, as it employed ‘inversion’ to acquire a foreign company and claim that as its corporate headquarters. 

*see FiDA post on Salazar v Boston Scientific Obtryx surgical mesh 73M verdict:  the company executives were aware of the irreversible, permanent, catastrophic harm and the MSDS stating that pp mesh product should not be implanted in humans and did not inform the implanting surgeons and patients.

_______________________________________________________________________

Government reveals $3.5 billion in industry ties todoctors, hospitals

September 30, 2014  LA Times

By CHAD TERHUNE, NOAM N. LEVEY

Opening the book on long-hidden industry relationships, the federal government revealed nearly $3.5 billion worth of payments and other ties that U.S. doctors and teaching hospitals have with drug and medical-device companies.

These financial details, published Tuesday under a requirement in the federal health law, have been sought for years by patient advocates and lawmakers from both political parties concerned about conflicts of interest in the medical profession.

Initially, the new federal website includes 4.4 million payments made during the last five months of 2013. More data will be published next summer.

Database

Officials said the data cover financial transactions involving about 546,000 physicians and 1,360 teaching hospitals across the country.

Consumer advocates hope the increased disclosure will ultimately help curb unethical practices by some doctors who prescribe medications and devices after receiving large sums from manufacturers, possibly putting patient care at risk.

Physicians and academic medical centers defend industry collaboration as essential to advance research into life-saving treatments. They have also questioned the accuracy of the government data.

The Physician Payments Sunshine Act was included in the Affordable Care Act that President Obama signed in 2010 amid growing demands for more openness in the U.S. healthcare system, which historically has shielded doctors, hospitals and other medical providers from much public scrutiny.

“The Sunshine Act is a watershed moment,” said Susan Chimonas, associate director of research at Columbia University's Center on Medicine as a Profession. “It’s a tantalizing first look at what kind of industry ties doctors have.”

In the last several years, the Obama administration has published data on how much hospitals charge for medical procedures and how much the massive federal Medicare program pays individual physicians.

At the same time, hospitals, nursing homes and others are being required to report an increasing number of quality measures to the federal government, which posts the data on a public website.

These industry payments have long been a target for patient advocates concerned about the huge sums companies expend to woo physicians with speaking fees, luxury trips and meals.

“It’s a widespread practice that does influence the kind of care patients get,” said Lisa McGiffert, manager of Consumers Union’s Safe Patient Project in San Francisco. “This exposure will require everybody to talk about something that’s been underground.”

In one national survey, nearly 30% of doctors said they received money for consulting, giving lectures or enrolling patients in clinical trials.

Medical groups have cautioned that the data on payments risk jeopardizing crucial collaborations that have helped foster medical breakthroughs that benefit patients.

“If the information made available to the public involves dollar amounts without full context, it can lead to gotcha-style news stories and healthcare providers facing the presumption of ethical wrongdoing even when they have done nothing wrong and their work is benefiting patients,” said Mary Grealy, president of the Healthcare Leadership Council, an association of medical industry leaders.

Major medical societies, including the American Medical Assn., have expressed concerns about the increased disclosures about physicians, often complaining that the data are not always correct.

In advance of the release of the new payment data, medical groups renewed their complaints that physicians had not been given adequate opportunity to review the information before it was published.

Dr. Shantanu Agrawal, a deputy administrator at the Centers for Medicare & Medicaid Services, said the new database "does not identify which financial relationships are beneficial and which could cause conflicts of interest. It simply makes the data available to the public."

The government website details a wide range of payments and financial information, from consulting fees, meals and travel expenses to physician ownership stakes in medical companies.

But the Obama administration said about 40% of the records published Tuesday don't include physician names because officials are still working to confirm the accuracy of the payouts. An additional 199,000 records are being withheld for now because they are either exempt from the reporting requirement or under dispute, federal officials said.

The law requires medical companies to report payments and gifts to physicians that exceed $10.

U.S. Sen. Charles E. Grassley (R-Iowa) authored the Sunshine Act after numerous investigations into conflicts of interest among physicians. He said the rollout may be rocky but the data will eventually become a valuable resource for consumers, insurers and taxpayers.

"It should empower consumers to learn whether their doctors take payments and if so, why and whether that matters to them," Grassley said.

Twitter: @chadterhune @noamlevey

Out of the Dark Ages! FDA requires medical device manufacturers to report adverse events on a computer!

FDA will require electronic reportson adverse events involving devices

By Virgil Dickson

Posted: February 13, 2014 - 3:30 pm ET

Hospitals, physicians and their patients soon may know if a medical device is faulty more quickly than in the past thanks to a Food and Drug Administration final rule issued Thursday. The rule requires manufacturers to submit reports of injuries or deaths associated with their products electronically to the FDA instead of via a paper report as is currently done.

Electronic submissions will make it easier for the FDA to review adverse events and rapidly communicate information about suspected problems to the medical-device industry, healthcare providers, consumers and other government agencies, it said in the rule.

For decades, the FDA has received these reports in a paper format through the mail. In 2009, the agency released a proposed rule that called for electronic reports on a voluntary basis. The final rule makes it mandatory to do so starting Aug. 14, 2015.

The FDA on average receives roughly 200,000 adverse events annually and can take anywhere from three days to six to properly analyze a report received by mail, according to the FDA. Others argue it could be even longer in some instances.

“It is no secret that, for years, paper medical-device reports were mostly warehoused,” said Jeffrey Shapiro, an attorney at Hyman, Phelps & McNamara.

The FDA estimates it oversees more than 20,000 device manufacturers and importers. The industry will face one-time costs of $40 million in training and IT changes to make the switch, the FDA estimated. However, device makers will save about $9.2 million annually because electronic submission should reduce the time needed to submit documents and reduce delivery costs.

A major change between the proposed and final rule: user facilities such as hospitals will not be required to comply with the e-filing requirement.

“This change from the proposed rule was obviously in response to comments concerning the increased costs for electronic submissions by entities that file a small number of reports each year,” said William Kitchens, a partner at the law firm Arnall Golden Gregory.

Small devicemakers are not exempt from the new requirement, however.

“There are many very small device manufacturers and I believe that this is going to be a burden for them,” said Wally Pellerite, an industry consultant and former FDA compliance official, adding that it makes the agency appear inconsistent to exempt hospitals but not small devicemakers. “Small device firms with few medical-device reports should be allowed to submit paper reports.”

Follow Virgil Dickson on Twitter: @MHvdickson