US Congress discusses medical device safety.

Consumers Union To Testify For Stronger Medical Device

Safety Oversight at House Hearing Today

 Congress Shouldn’t Sacrifice Patient Safety In The Driveto Speed Up Medical Device Approvals, CU Says

 WASHINGTON, D.C. – Lisa Swirsky, senior health policy analyst for Consumers Union, will urge Congress today to strengthen medical device safety oversight in testimony before the House Energy & Commerce Health Subcommittee. The subcommittee will hold a hearing on the reauthorization of the Medical Device User Fee Act beginning at 10:15 AM in Room 2322 of the Rayburn House Office Building.

Recent safety problems with metal hip implants and surgical mesh have underscored how lax federal oversight of medical devices fails to protect patients. Consumers Union has called on Congress to require more rigorous testing before medical implants are allowed on the market and to establish a better system for monitoring devices after approval, including a national system for notifying doctors and patients when safety problems come to light.

“Congress has the opportunity to fix a flawed system that allows too many unsafe medical devices to enter the market,” said Lisa Swirsky, senior health policy analyst for Consumers Union, the nonprofit advocacy arm of Consumer Reports. “But so far, the debate in Washington has been all about how to make it easier for industry to rush new devices to the market without addressing the need to protect patients from potential safety hazards. Americans are counting on lawmakers to strengthen the law to ensure timely access to new medical devices without sacrificing patient safety.”

In her testimony before the subcommittee, Swirsky notes that the recent user fee agreement negotiated by the U.S. Food and Drug Administration (FDA) and the medical device industry, fails to make any patient safety improvements and falls short of providing the resources needed to meet the increasing demands on the agency. The FDA had previously indicated that it needed between $770 million and 1.15 billion to implement the performance goals pushed by industry. Instead, the medical device industry has agreed to $595 million in user fees.

Swirsky’s testimony highlights additional concerns about the agreement, including new performance goals for the FDA that may inhibit the agency’s ability to get the information it needs to properly evaluate medical device applications. Her testimony also raises concerns about potential conflicts of interests involving industry-funded patient groups that could be involved in evaluating new devices.

In addition, Jim Shull of Browns Mills, New Jersey, will testify at the hearing about his experience as a patient harmed by synthetic mesh used for a hernia operation. Six years after his operation, Shull is living with daily pain from the mesh that has caused severe nerve damage and other debilitating complications.

“The mesh that was put inside of me has caused so much damage that none of the nerves can ever be repaired,” said Shull. “Now I face a lifetime of pain and struggle because of it. Surgical mesh and other medical devices should be tested for safety before they are allowed to be implanted into people like myself.” 
For more details on the reforms Consumers Union is urging Congress to adopt, see the Safe Patient Project’s Improve the Safety of Medical Devices fact sheet.

Contact: David Butler, dbutler@consumer.org or Kara Kelber, kkelber@consumer.org, 202-462-6262 or Michael McCauley, mmccauley@consumer.org, 415-902-9537 (cell)

2011 report: 10% of Medicare payments go toward fraudulent claims.

MedPage 2/14/2011 Emily P. Walker LINK HERE

2011 Healthcare Fraud Recovery Largest Ever

By Emily P. Walker, Washington Correspondent, MedPage Today

Published: February 14, 2012

WASHINGTON -- The federal government recovered $4.1 billion in fraudulent healthcare payments in fiscal 2011, the largest amount ever collected in a single year, federal officials announced Tuesday.

Ramped-up fraud-fighting efforts led to a 50% increase from 2009 to 2011 in judgments and settlements of payments fraudulently obtained from Medicare and Medicaid, according to the Justice Department and the Department of Health and Human Services (HHS).

The payback results from another record number: criminal charges were filed against 1,430 defendants for healthcare fraud-related crimes, according to HHS.

A total of 743 defendants were convicted during the year, HHS said. The cases included durable medical equipment fraud; illegal marketing of medical devices or drugs for uses not approved by the FDA, including unlawful pricing by drugmakers; and violations of self-referral and anti-kickback laws.

Much of the success stemmed from the Health Care Fraud Prevention & Enforcement Team (HEAT), a task force created in 2009 to prevent fraud, and the Medicare Fraud Strike Force teams.

Those teams use data analysis to identify high billing levels in healthcare fraud hot spots -- such as Detroit and Miami -- to target for investigation and possible prosecution. In 2011, the teams added Chicago and Dallas to their "hot spot" list, which brought the total number of targeted cities to nine, including Los Angeles, Houston, Brooklyn, N.Y., Baton Rouge, La., and Tampa, Fla.

"Fighting fraud is one of our top priorities and we have recovered an unprecedented number of taxpayer dollars," said HHS Secretary Kathleen Sebelius in a press release. "Our efforts strengthen the integrity of our healthcare programs and meet the president's call for a return to American values that ensure everyone gets a fair shot, everyone does their fair share, and everyone plays by the same rules."

The Affordable Care Act includes $350 million in healthcare fraud-fighting funds. One new provision in the law requires those providers and suppliers wishing to participate in Medicare, Medicaid, and the Children's Health Insurance Program that have been deemed to be at higher risk of fraud or abuse to undergo licensure checks and site visits to confirm legitimacy.

The $4.1 billion was either paid back to the U.S. Treasury or to the Centers for Medicare & Medicaid Services, transferred to other federal agencies that administer healthcare programs, or paid to private persons who were the victims of Medicare fraud.

Since the Health Insurance Portability and Accountability Act established a national healthcare fraud and abuse program in 1997, $20.6 billion has been paid back to the Medicare program.

A government report from 2011 found that nearly 10% of all Medicare payments go toward fraudulent claims.

1 Comment

Joleen Chambers

Today 2/15/12 at 10 ET the House Energy and Commerce Committee/Subcommittee on Health will be discussing Reauthorization of MDUFA: What It Means for Jobs, Innovation and Patients. The #1 expenditure of Medicare is joint replacement and the IOM 7/29/11 reported that the FDA mechanism for clearing implanted medical devices - 510(k)- is legislatively flawed and should be scrapped. Victims of failed implanted medical devices are in medical and legal purgatory and our economy is in peril as a result of these expensive mistakes. Innovation does not equate success. Our economy will be sustainable when citizens have jobs that enhance our nation. The medical industry does not get a "pass". It is revealing that "patients" are mentioned last-again!

US Safety Advocates Lobby Congress for Safer Implanted Medical Devices: Consumers Union

Safety Advocates Unveil Device Safety Agenda, Ramp Up Lobbying

Consumer safety advocates are unveiling a broad medical device reform agenda as they increase lobbying efforts on Capitol Hill, with groups focusing on more rigorous approval for implantable devices, restrictions on using recalled predicates, increased requirements for post-market studies, implementation of the delayed unique identifier system and a national device registry, and greater scrutiny of direct-to-consumer medical device advertising. A safety advocate said there is momentum in the Senate to include some reforms in the user fee act legislation.
Consumers Union's Safe Patient Project this week brought eight patient safety activists from around the country to Washington to meet with lawmakers and press for improvements to the Medical Device User Fee Act. Consumer groups are also meeting with congressional staff as lawmakers work on legislation in this area, according to sources.
The activity comes as FDA and industry work to put the finishing touches on a negotiated agreement on medical device user fees, with a hearing on the issue scheduled for Feb. 15. Consumer advocates said the agreement does not reflect the safety priorities that they had discussed with FDA during the negotiations, such as not allowing companies to use recalled predicates for 510(k) clearance and giving the agency the authority to require post-market studies.
Safety advocates are now turning their attention to Capitol Hill, and banking on news about faulty medical devices to help bolster their cause, although some sources have said medical device safety measures could be a difficult sell as lawmakers increasingly focus on reducing regulation to promote innovation in the medical device sector.
One source said while there is interest in Congress around safety reforms, lawmakers are still working out their plans for moving these ideas forward. Legislation could be introduced as a side-car to the user fee bill, but one source said there have been some bipartisan conversations in the Senate around including some reforms in the user fee act itself.
"They are developing language that will be ready to go one way or another," one safety advocate said.
Reforms aimed at direct-to-consumer advertising for medical devices, like billboards, are gaining traction in Congress, according to one safety advocate, who added that this issue, along with UDI, and predicate reform -- included in a recently introduced House bill -- are getting the most attention on Capitol Hill right now. The source said post-market reforms are more broad at this point.
"While the user fee program is structured in a way that FDA has to be more responsive to industry than to us, Congress is still responsive to their constituents," the safety advocate said.
Consumers Union is pushing a broad medical device safety agenda that includes pre-market and post-market reforms, as well as retaining current conflict-of-interest rules -- an area some in Congress are seeking to loosen although FDA has indicated a legislative fix might not be necessary.
Specifically, the group wants all implantable devices to go through the pre-market approval process, and wants to prohibit use of recalled devices or devices with a warning to be used as predicates in the 510(k) clearance progress. It also proposes to give FDA authority to require post-market studies, including long-term studies to demonstrate longevity of devices, and raise the safety standard for devices in line with prescription drugs by changing the PMA standard from "reasonable assurance" of safety to "substantial evidence" of safety.
The group is also calling on FDA to implement the UDI system, which has been held up at the White House Office of Management and Budget, create a national registry for devices, and ensure the agency has adequate resources for better post-market surveillance programs including MedWatch, MAUDE and Sentinel. In addition, Consumers Union said the current conflict-of-interest standards should be retained, a measure they advocated for five years ago during the last reauthorization of user fees.
Some of these measures have already garnered interest on Capitol Hill, with a group of House Democrats introducing legislation that would prevent recalled devices from being used as predicates. A group of senators also introduced a bill that would require conditional approval for some devices cleared through the 510(k) process, although the legislation has met opposition from industry and some consumer groups, who have said those reforms do not go far enough and could loosen some pre-market requirements.

The US exports failed medical devices to the UK

LINK HERE: Failed hips causing international concern

U.S. GAO- Government Accounting Office- uncovers secrecy on medical device prices

LINK HERE to full story by Star Tribune reporter James Walsh

Secrecy on medical-device prices hurts buyers, GAO says

•                Article by: JAMES WALSH

•                Star Tribune

•                February 11, 2012 - 2:40 PM

Hospitals are paying widely varying prices for the same implantable medical devices, according to a new study that suggests that secretive sales agreements prevent many buyers from getting the best deals.

The report from the U.S. General Accounting Office -- which turned up a difference of more than $8,000 for one cardiac device alone -- found that confidentiality clauses in sales contracts keep even the physicians who decide which devices to use in the dark about prices.

The study, which was requested by U.S. Sen. Max Baucus, a Montana Democrat who chairs the Senate Finance Committee, could add fuel to a push to lift the price veil.

"The real problem is that, on the local level, there are these gag clauses that prohibit the sharing of pricing information," said Curtis Rooney, president of the Healthcare Supply Chain Association (HSCA). "I do think [the GAO report] lays the groundwork for more questions to be asked."

Don May, vice president of policy for the American Hospital Association, said the study "highlighted some of the real concerns about devices."

Device pricing is an issue of critical importance locally. Minnesota is a primary medical technology hub, home to industry giants Medtronic and St. Jude Medical and hundreds of other smaller companies employing thousands of people.

Officials with top local device companies declined to comment on the GAO's findings, referring calls to the Advanced Medical Technology Association (AdvaMed), a medical device trade association.

David Nexon, a senior executive vice president for AdvaMed, said the industry is extremely competitive and that pricing involves many factors. Overall, however, he said that medical technology prices "have risen far more slowly than price increases for other medical goods and services and substantially less than even general price increases in the economy as a whole."

Nexon did not specifically address confidentiality clauses. But he said prices reflect "the number of competitors in the marketplace, a particular hospital's volume of business in a particular procedure and the volume of other products sold to that hospital by a manufacturer."

As the GAO report noted, hospitals typically negotiate device prices with manufacturers directly or through group purchasing organizations (GPOs). But device manufacturers often require hospitals to sign confidentiality clauses that forbid them from revealing to third parties the price they paid. Those third parties often include physicians, whose device preferences influence hospital purchasing decisions.

"It really is this relationship between the manufacturer and the physician," Rooney said. "The physician orders the product but can't know what the price is. The hospital becomes the third-party payer."

The GAO sought information for its study from more than five dozen medical centers and others involved in the health care system. It received detailed information on cardiac device prices from 31 hospitals, one GPO and one Department of Defense medical center. Only 14 hospitals and two Department of Defense facilities gave detailed information on orthopedic devices.

Those responses showed huge price differences. For example, the difference between what the lowest- and highest-price hospitals paid for a particular model of automated implantable cardioverter defibrillator (AICD) was $6,844. For another, the price difference was $8,723. Median prices for four AICD models ranged from $16,445 to $19,007.

The cost to the government alone could be substantial. Considering that Medicare spent nearly $20 billion on implantable medical device hospital procedures in 2009, a rate equal to what Medicare spent for all other hospital procedures, "excess or unnecessary IMD costs that hospitals incur may be passed on to the Medicare program," the GAO report said.

'Armed for battle'

There are hospitals that go in with their eyes open.

Minneapolis-based Allina Health won't accept gag clauses in its contracts, according to Cheryl Harelstad, vice president for supply chain management. Years ago, she said, such clauses weren't really questioned.

"A lot of health care providers are working hard, saying, 'Wait a minute. This doesn't put us in a very good position,'" she said.

Allina belongs to a GPO, Novation, that strikes agreements with suppliers and establishes multiple price tiers for devices, Harelstad said. GPO members pay a fee for that information and sharing it is critical, she said. Allina, which has some buying clout because of its size, will then go to manufacturers to adjust prices further.

"We go in armed for battle," Harelstad said of the importance of pricing information.

"To be fair," she said, "our suppliers work well with us on this."

Rooney said confidentially clauses in device contracts are not new. "This has been going on quite a while -- at least a decade," he said. Legislation requiring more price transparency was introduced in Congress in 2007, but was not enacted.

Now, as more Americans age and health care costs become an even bigger issue, Rooney said the issue of device costs is heating up again.

"This begins the conversation that needs to occur in Congress," he said. "In the era of cost containment, people should know they are getting the value they deserve in terms of health care costs. People are getting older and grayer, and more of these devices will be implanted."

James Walsh • 612-673-7428

 

explanthisFeb. 12, 128:07 AM

http://fida-advocate.blogspot.com/ FDA MedWatch Adverse Event #5009052 was not investigated and according to Freedom of Information, the record was "lost". Mayo Clinic and the surgeon/designer are legally able to abandon the patient. The entitlement of the medical device industry will cripple not only our elders, but our nation. Medical and legal purgatory is not an "innovation" that patients demand but if a device fails, that is the result. No pre-market clinical testing, mass production and no registry for devices and an uninformed consumer is the recipe for disaster. Is the GAO report "shrill" or accurate? I vote for accurate!

Knee replacements have tripled from 1997 to 2009

(Link here) 5% of Americans over age 50 have artificial knees!

The article was published today by AP reporter, Lindsey Tanner.   The US does not have a national registry of implanted devices and the medical device industry has resisted it for 20 years.  Consumer/taxpayer outrage must counter the powerful lobby of the medical device industry to propel Congress to change the charter of the FDA.  Give us our damned data so that we can make life-enhancing decisions!  Joint replacements are the #1 expenditure of Medicare.  Taxpayers paid for a large majority of procedures and the aggregate data generated from those purchases should be made available to patients/citizens/taxpayers.  It is NOT proprietary information!

The Department of Transportation investigates/regulates/recalls effectively:

(Link here) Toyota RAV4 recalled for power window switch defect that may cause fire.

Product Safety Commission investigates/regulates/recalls effectively:
(Link here) Coffee makers recalled for burn risk.

The FDA missed the failures of 37,000 failed J&J metal on metal hips.

Our economy is dependent upon getting this right.  No more victims of medical and legal purgatory of failed implanted devices!

Congress: put public health before medical device industry

U.S. Victims bravely tell their stories. This is so very wrong.

My brother and I are grateful to be with the Consumers Union Patient Safety Project.  We have met with Congressional office holders and their staffs to demand better regulation of implanted medical devices.  The response has been discouraging since there are 12 proposed pieces of legislation pertaining to medical devices, but none includes patient safety and public health protections.  The medical device industry is lucrative and has a powerful lobby.  This is an election year and politicians are raising money.  That is an excuse for not doing their job: protecting American citizens from unsafe and unproven implanted medical devices.  Corporations that have been granted the privilege (not entitlement) by the citizens of the United States to do business in our country must act as lawful and ethical businesses.  Using influence to corrupt regulations so that failed medical devices are not identified and banned and obscuring information that would inform patients so they can select life-enhancing devices is criminal.  It must stop.
Steven Baker, MedWatch # 5009052 came to Washington, DC and encountered the metal detector at the Senate Hart Office Building.  He was asked to take off belt and shoes and his implanted elbow suddenly went "out of alignment" .  During his presentation he was asked if we should call an ambulance.  It is unreasonable to ask the victims to do anymore.  It is time for the medical device industry to be honest, responsible and account for the failures as well as the successful innovations that it produces.  Our economy cannot sustain this and no patient deserves this medical and legal purgatory.