Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements.
Twitter: JjrkCh

Friday, May 22, 2015

Write to cures@mail.house.gov by June 13, 2014. Here's why!

21st Century Cures – Patients 

“There are 7,000 known diseases. We have treatments for only 500 of them. We have work to do.”
For patients and their families, the gap between the number of diseases and the number of treatments is not a statistic; it is their daily struggle. Despite the medical breakthroughs of recent years, for many diseases, treatments or research simply do not exist. 
Through legislation such as the Food and Drug Administration Safety and Innovation Act and the PREEMIE Reauthorization Act, which included the National Pediatric Research Network Act, the Energy and Commerce Committee has sought bipartisan solutions to facilitate and accelerate patient access to innovative treatments. Although progress has been made, significant work remains. That is why we launched the 21st Century Cures initiative, and the involvement and guidance of those patients on the frontlines and their advocates is critical. Our goal of accelerating the cycle of discovery, development, and delivery of promising new treatments and cures is shared by many, but perhaps most of all by patients and their families. 
The committee appreciates that certain aspects of the discovery, development, and delivery cycle have different meanings for different patients. Depending on the condition or disease at issue, the state of biomedical research, and the translation of such research into treatments and cures, varies. We want to hear about the state of biomedical research and therapeutic innovation for specific diseases and better understand how Congress can help move the ball forward. 
To help the committee’s effort, we are seeking input from the patient community on the following questions: 
�� What is the state of discovery of cures and treatments for your disease? Are there cures and treatments now or on the horizon? 
1 Statement of Margaret Anderson, Executive Director of FasterCures, at the 21st Century Cures Roundtable held on May 6, 2014, http://www.youtube.com/watch?v=Fr4Re7sfDzE&t=33m21s

  • ��  What programs or policies have you utilized to support and foster research, such as patient registries, public-private partnerships, and venture philanthropy?
  • ��  How can Congress incentivize, coordinate, and accelerate basic research for diseases we know relatively little about?
  • ��  How can we work together to better translate advances in science into safe and effective new therapies for patients?
  • ��  How do you coordinate your research and outreach with other patients?
  • ��  How do you learn about new treatments and cures? How do you communicate with other
    patients regarding treatments and cures?
  • ��  What can we learn from your experiences with clinical trials and the drug development process?
  • ��  What is the role of government in your work, including any barriers to achieving your goals and advancing breakthroughs?
  • ��  How should regulators evaluate benefit-risk? How do you work with regulators regarding benefit-risk? Can this process be improved?
  • ��  What is the role of public and private funding in the research and development of cures and treatments?
  • ��  Are there success stories the committee can highlight and best practices we can leverage in other areas?
  • ��  How have you worked with other patients to support one another?
  • ��  What is the financial burden of your disease? How would better treatments and cures help
    save money for your family and the federal government?
  • ��  How can Congress help?
    Public input is critical to the 21st Century Cures initiative, especially from the patient community. With the staggering gap between the number of diseases and available treatments, there are undoubtedly countless untold stories that will provide guidance and perspective in this effort. We request all submissions and suggestions be sent to cures@mail.house.gov by June 13, 2014. 
http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/analysis/21stCenturyCures/20140516PatientsWhitePaper.pdf


Thursday, May 21, 2015

Australian pelvic mesh implant doctor barred from surgery.


Medical Council stops Reid from doing major surgery 


May 18, 2015, 11 p.m.

THE NSW Medical Council placed Dr Richard Reid under practice conditions in 2011, including that he obtain ‘‘valid informed consent for the surgery he performs’’, after complaints and at least three civil settlements against him.
He was suspended in July last year and his offices in Sydney and the Central Coast were closed after the Medical Council determined he posed a risk to the public with his use of the Tissue Fixation System of mesh products to treat women’s prolapse problems after childbirth.

Dr Reid was reinstated in November after appealing to the NSW Civil and Administrative Tribunal, which noted the ‘‘experimental’’ nature of some of his work.
The Therapeutic Goods Administration deregistered the Tissue Fixation System mesh products a week later.
The Civil and Administrative Tribunal was told there were 14 complaints against Dr Reid between 2002 and 2014.
The Medical Council barred Dr Reid from performing major surgery in March. He was also ordered not to treat patients in consultation with deregistered South Australian psychologist Marek Jantos, who was found guilty of gross professional negligence, malpractice and misconduct in 2007 over his treatment of a female patient.

The Health Care Complaints Commission is investigating a number of complaints against Dr Reid.
Maurice Blackburn principal Anna Walsh said her law firm was likely to be issuing court proceedings in a few months on behalf of several women who received the Tissue Fixation System mesh product during surgery by Dr Reid.
‘‘From our investigations so far it seems that many women were not given enough clear information about why they needed to have this procedure with this device and they have been left with very poor outcomes which in many cases are irreparable,’’ Ms Walsh said.
Dr Reid’s colleague Dr Peter Petros, who developed the Tissue Fixation System, is also being investigated by the Health Care Complaints Commission.

Dr Petros did not respond to a request for comment. 
http://www.theherald.com.au/story/3086840/medical-council-stops-reid-from-doing-major-surgery/

Tuesday, May 19, 2015

Patient Outcome Registries: Proprietary and Inaccessible to Oversight

Who Keeps Track If Your Surgery Goes Well Or Fails?

MAY 03, 2015 5:20 AM ET




In order to improve the quality of health care and reduce its costs, researchers need to know what works and what doesn't. One powerful way to do that is through a system of "registries," in which doctors and hospitals compile and share their results. But even in this era of big data, remarkably few medical registries exist.
Dr. Martin Makary is a surgeon at the Johns Hopkins School of Medicine. He and his colleagues published a study online this week in the Journal for Health Care Quality about the major shortcomings in the way patients are tracked after treatment.
I had a chance to speak with Makary about his interesting findings. The following is an excerpt of our conversation, edited for brevity and clarity:


Makary: For 99 percent of people in America, when they go in to have surgery, the outcome [of that operation] is not measured. Nobody's keeping track. So I'm amazed at how one-fifth of the economy, [the share accounted for by the healthcare system], functions with so little measure of its performance.
Harris: What inspired you to do this study?
Makary: I do an operation known as pancreas islet transplantation, and we send our outcomes to a national registry. I tried to get the data from that registry to better understand the disease and the outcomes from different centers, and I found out I couldn't get access to the data. I found it ironic that the data warehouse is funded by the taxpayers, and yet I can't even get access as a participating center. So it really got me curious about how many other diseases are being tracked in a national registry that is taxpayer-funded and that is also not transparent and available to the public.
Harris: What's the point of collecting the data if it's not made available to researchers who want to examine it?

Makary: The truth is, it's held in proprietary housing, and sharing it is not as easy as it sounds in principle. Instead [people who are trying to evaluate the medical system] focus too much on a few things that are very easy to measure, like patient satisfaction. Patient satisfaction may not even correlate with the appropriateness or the quality of the operation. I know people who have had unnecessary operations but are totally satisfied with them!
Harris: Turning to your paper now, what was your biggest surprise?
Makary: The biggest surprise was that [among the 153 registries we identified] there is tremendous variation among the different medical specialties. And the other big surprise was that only 18 percent had any form of auditing to verify their data. Now, on Wall Street we would never accept an 18 percent auditing rate when companies report their earnings. As a matter of fact, if a company misreports their earnings, the CEO goes to jail.
Instead of focusing on outcomes, we have a huge upfront effort to approve a new device or a new medication. We put them through the ringer. And once they're released, nobody's tracking anything. You have no idea how people are doing with a new medication or a new knee joint. New surgery is untracked for the most part.
Harris: There are financial incentives for companies not to know those answers. Hospitals, device makers, drug makers — if they're selling something already, the only news can be bad news, right?
Makary: Absolutely. Life is good right now if you get FDA approval. And hospitals don't want to spend the $60,000 to $80,000 a year to participate in a registry.
Harris: Hospitals could worry about losing patients. If you're looking at who's in the top 10 percent of all hospitals in terms of treatment outcomes, that's only 10 percent of the hospitals. And the other 90 percent might say this doesn't serve their interest in attracting patients.
Makary: You're exactly right. Hospitals are not malicious, but there's no incentive for them, from a business standpoint, to chase down their outcomes and measure their performance for internal quality improvement.

Harris: Can you give me an example of an instance where data gathered in a manner like this changed the way care was provided?
Makary: The best registry in America, in my opinion, is the cystic fibrosis registry. It has been around for 20 years. I believe that because of the cystic fibrosis registry we've been able to prolong the survival of kids with cystic fibrosis by almost two decades.
Also, Dr. Douglas Rex at Indiana University, who was frustrated at the problem that doctors were doing colonoscopies too quickly and inappropriately, decided to secretly record the videos of a whole bunch of doctors doing the procedure. He then told his colleagues, "I'm going to be watching your videos." Instantly, the quality scores improved by 40 percent.
If we're going to get serious about reining in healthcare inflation, we have to get serious about measuring our performance in health care. Everybody agrees about that. The actual work of measuring patient outcomes is what's missing.



http://www.npr.org/sections/health-shots/2015/05/01/403611589/who-keeps-track-if-your-surgery-goes-well-or-fails

Monday, May 18, 2015

Take Action Now! Tell Congress NO on 21st Century Cures bill.

Congress is working on a bill called 21st Century Cures that would lower the standards for approving drugs and medical devices.  They say it will benefit patients, but it was written primarily by industryUnfortunately, a key vote will be tomorrow  morning 5/19/2015!

The National Center for Health Research has drafted a letter to the House of Representatives for individuals to sign with their name and city/state/zip code.  Please spread the word to friends and relatives that care about safe medical products!   
I can’t emphasize enough how important it is that Congress hear from as many individuals as possible NOW!

Diana Zuckerman, Ph.D.
President
National Center for Health Research
Cancer Prevention and Treatment Fund
1001 Connecticut Ave, NW, Ste. 1100
Washington, DC 20036
(202) 223-4000

CONSUMER VERSION
Dear Representative XXX,
As patients and consumers from across the country, we are writing to share our very strong opposition to several sections of the 21st Century Cures legislation.  A few of the issues of particular concern to us follow.  We are not lobbyists, we are American taxpayers, and we hope you will improve the bill to better reflect the needs of regular people like us. 
Subtitle D: Modern Clinical Design, Section 2062 and 2063
FDA standards have developed over the last 100 years so that Americans could trust that medical products are proven safe and effective in scientific studies on humans.  Randomized clinical trials are the gold standard to make sure that a new drug, device, or vaccine is safe and effective.  This section encourages the FDA to lower its standards to even include anecdotes that the bill calls “clinical experience.”  Please remember that clinical experience resulted in tragedies such as thalidomide and the Dalkon shield.  
Whether the FDA is reviewing a drug for a new use, for long-term studies after a drug is already approved, or for a new drug, the FDA should compare the drug to make sure its benefits are greater than its risks for most patients.  That means it needs to be studied on hundreds of men and women, of different ages and different races.  
In medicine, physicians are looking for “evidence-based medicine” not the opinions of a few doctors.  That’s why this section is so dangerous for patients: it would allow the use of individual experiences or summaries of studies (instead of the details of the studies)
 Sections 2121: Approval of Drugs for a Limited Population of Patients
We all worry about antibiotic resistance, but this section tries and fails to address it.  It discourages the FDA from relying on randomized clinical trials that evaluate the impact of a drug on real patients, and instead encourages the FDA to rely on preliminary data.  That might be justifies for patients who would otherwise die without an experimental drug, but unfortunately there is no way for the FDA to prevent these drugs from being promoted and prescribed for all patients.  Millions of patients could die as a result.
4.      Section 2123: Encouraging the Development and Use of New Antimicrobial drugs
This section would pay a bonus to hospitals to prescribe new antibiotics and anti-fungals.  But, these drugs should be used only when needed, to preserve their effectiveness as long as possible.  Many frail elderly patients are put on antibiotics whenever they get sick, in order to prevent pneumonia.  If Congress encourages hospitals to prescribe these new drugs, it encourages overuse and inappropriate use.  The result: fewer effective antibiotics and a Medicare system that goes broke even sooner than many have predicted.
5. Subtitle L, M, and N:  Medical Devices:  
FDA standards for medical devices are lower than for drugs, resulting in patients harmed from artificial hips, unsafe stents, contact lens solution, surgical mesh, and many other common devices.  The device sections in this proposed legislation would lower the standards even more.  How does that make sense? 
Section 2221, Third-party Assessment:  When a company wants to make changes to a medical device that is already on the market, FDA scientists should decide if the changes will change the safety and effectiveness of that product.  Companies should not be allowed to choose to pay a 3rd party to decide if FDA needs to review those changes.  That is just common sense.
Section 2222,  Medical Device Approvals: This section lowers the standards FDA uses to approve high-risk medical devices such as heart, brain, and spinal implants.  It would allow approval based on case studies, which include only one or two patients.  But the experience of a small number of patients is not necessarily typical of what will happen to most patients, especially patients of the opposite sex or different age.  It would also allow evidence from peer reviewed medical journals instead of evidence from the actual patient data.  Unfortunately, studies in medical journals can be inaccurate, incomplete, or biased.
Health Software: Electronic medical records and other health software help doctors make medical decisions about their patients.  That’s why it is important that the software works well and won’t crash when the patients’ lives are at stake.  FDA should evaluate these devices at least as carefully as they evaluate hip and knee implants, for example.
6.   Section 3041:  Reducing Transparency in the Sunshine Act for Physicians Payments
We are glad that Congress previously required companies to make public their payments to physicians.  That law helps patients know if their doctors have a financial relationship with a company that makes a drug or device that the physician is recommending.  So we are very disappointed that Congress has already proposed a loophole for fees or gifts to doctors that are intended for “continuing medical education” purposes at fancy resorts or other meetings. It also would exempt expensive gifts such as medical textbooks and journals. Although we want doctors to be up-to-date in their education, we believe doctors make enough money to buy these themselves.  
As patients and consumers from across the country, we ask you to pause before passing this bill.  You’re moving too fast on a law that will affect every single person in this country.  We deserve a better bill and a more careful review of the fine print that could save lives if done correctly, and cost many lives if it isn’t very carefully evaluated and revised.

Sincerely,

Criminal behavior, but no jail time. Lives lost, PREVENTABLE harm. Follow the money.





Published : Friday, May 15, 2015 | 2:50 PM  (FiDA highlight)
Several hundred women that were represented by a Los Angeles-based attorney were a part of a $119 million settlement against a Massachusetts-based medical company over claims that its vaginal mesh product did not work and caused serious injuries.
“Most of the claims assert that the device manufacturer failed to properly test the pelvic mesh implant, ignored warnings, or that the device implanted into human tissue did not work and sometimes caused very serious problems,” said Los Angeles lawyer Dana Taschner, representing hundreds of women in the national medical device litigation involving several device
manufacturers.
Surgical mesh products were implanted in women in an effort to treat pelvic organ prolapse, stress urinary incontinence, and following hysterectomies.
Medical Device Company Boston Scientific agreed to settle thousands of lawsuits involving a vaginal mesh product, including the claims of an area woman claiming injury from the company’s transvaginal mesh medical device. Boston Scientific is paying $119 million to resolve almost 3,000 cases around the country, Taschner said.
“The trial that settled this week is one of thousands of transvaginal mesh lawsuits in federal and state courts across the country alleging product flaws” he said.
Boston Scientific claimed no admission of wrongdoing in the settlements, and insists their mesh medical device is not faulty or to blame for alleged problems.
Payments in the settlement are to be paid into a settlement escrow by the device manufacturer by October 1, 2015. Boston Scientific has reportedly set aside close to $1billion to cover costs, liabilities, legal expenses, and settlement associated with continuing transvaginal mesh and bladder sling claims.
Two other recent cases involving Boston Scientific resulted in significant and expensive defeats for the company.  In Miami, Florida, a federal jury returned a verdict of $26.7 million after plaintiffs argued that the company’s Pinnacle mesh device design was faulty and caused serious problems.
In another case in West Virginia, the jury returned a verdict of $18.5 million after the plaintiff sued Boston Scientific for injuries the plaintiff claims are a result of the medical device.
In addition to Boston Scientific, several other medical device companies are defending lawsuits for alleged transvaginal mesh problems.
“Boston Scientific is still exposed to claims from thousands of women claiming injury from the medical devices” said Taschner.
As of February, more than 25,000 product liability cases or claims regarding the mesh products had been made against the company, according to Boston Scientific filings.
Boston Scientific spokesperson Kelly Leadem said in an e-mail Tuesday that when it comes to those other cases and claims, the company will continue to look at all of its options.
“If there are opportunities to settle cases at reasonable terms in the future, then we will consider settling,” said Leadem in the e-mail. “Otherwise, we will continue to contest these claims

vigorously.”


Friday, May 15, 2015

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.



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.