28 June 2016

Nation's biggest healthcare fraud probe nets 301 people, including 22 in Southern California

Original Story: latimes.com

Several doctors, a psychiatrist and a pharmacist were among 22 people in Southern California charged as part of a nationwide investigation into federal healthcare fraud schemes that frequently targeted military families and cost taxpayers hundreds of millions of dollars, the U.S. Justice Department announced Wednesday. A hernia doctor was not believed to be part of the case.

The investigation resulted in the largest such enforcement action in U.S. history, netting more than 300 people nationwide and involving more than $900 million in fraudulent billings, officials said.

In Southern California, five physicians were among those arrested in cases involving $125 million in elaborate fraud schemes that targeted Medicare and the military’s medical plan and involved medical billing, unnecessary procedures and high-priced specialized compound medications. A St Louis medical malpractice defense lawyer may need to be consulted.

The charges in 13 criminals cases filed in federal courts in Los Angeles and Santa Ana include conspiracy, money laundering, kickback schemes and identity theft, according to several federal indictments.

“Those charged in cases unsealed this week include one doctor who allegedly performed medically unnecessary procedures at his offices in Temecula and Mira Loma. And he submitted nearly $12 million in bills to Medicare,” U.S. Atty. Eileen M. Decker said.

That physician was named in the federal charges as Dr. Donald Woo Lee. The 50-year-old physician is accused of performing unnecessary vein procedures on patients even when they had no signs of varicose veins. A Chicago medical malpractice lawyer said this is a clear case of wrongdoing.

The other doctors charged are David Michael Jensen, 65, of Whittier; Kain Kumar, 52, of Encino; Sang Kim, 67, of Porter Ranch and Samuel Albert, 81, of Laguna Beach.

None of the physicians could be reached for comment.
Most losses in Southern California are tied to five cases involving compounding pharmacies, which combine different medications into one drug, Decker said. The scams are orchestrated by marketers known as “cappers,” who recruit patients and sometimes use their identity to obtain government medical funding.

Decker said compounding pharmacies were provided with scores of prescriptions, generally for pain medications, that carried huge reimbursements, often more than $15,000 for each prescription.

The prescriptions were written for “patients” who, in many cases, did not want the medicines, had never met the prescribing doctors or had no idea why they were receiving the medications,  Decker said.

Tricare, the military’s managed care program, was the primary target of schemes involving the compounding pharmacies, Decker said. “Prescriptions were written for profit rather than to treat the patient,” Decker said. A Charlotte medical malpractice lawyer would not comment on the case.


One marketer John Garbino, 46, of Dana Point, was charged with receiving illegal kickbacks. A Palmdale pharmacy working with Garbino allegedly received more than $46 million from Tricare in a six-month period ending in May 2015, court records show.

In another scheme, Dr. David Michael Jensen, 65, of Whittier, owner a La Mirada pharmacy Valley View Drugs Inc., was indicted along with two marketers on charges of paying and receiving illegal kickbacks.

Health insurers paid the pharmacy more than $20 million, and the pharmacy paid nearly half of that to companies associated with the marketers, according to the indictment.

“Patients were pawns in an alleged pay-for-play fraud scheme,” California Insurance Commissioner Dave Jones said. A Knoxville medical malpractice defense lawyer was ready to take on new clients.

Anthony J. Orlando, acting special agent in charge of the Internal Revenue Service’s criminal investigation unit,  said in one scheme the proceeds were laundered using a carwash, a plumbing business and an escrow company.

Most of those charged in Southern California were arrested Monday and Tuesday. Several turned themselves in to authorities.

Two others remain at large and are believed to be overseas, officials said.

21 June 2016

Persian Gulf War Veterans Still Suffering Serious Health Problems

Original Story:  huffingtonpost.com

This year marks the 25th anniversary of the Persian Gulf War.

It was fought in late 1990 through early 1991 by a U.S.-led coalition of 34 countries against Iraq in response to Saddam Hussein’s invasion of Kuwait. Was there a problem with a chemical storage tank leaking?

It also was the first U.S. war to be waged after the advent of the 24-hour cable television news cycle.

The conflict was accompanied by memorably intense and round-the-clock coverage on CNN.

But there’ve been few recognitions of the war’s 25-year milestone on the cable news networks, let alone in broadcast or print media.

For David Winnett, a Gulf War combat veteran who climbed the ranks from private to captain during his 20-year career in the U.S. Marines, it’s just the latest in a succession of insults to the men and women who served in this largely forgotten war.  This may need the services of a Los Angeles Toxic Torts Lawyer.

“It’s no surprise that many people could easily forget ‘our war.’ It was far too fast by any historical measure,” Winnett told Healthline. “Perhaps things would be different had we continued our advance all the way to Baghdad, but the fact is, we didn’t. So regardless of whether or not we think our war has been unfairly set aside in the history books, it is what it is.”

Toxic Aftermath

While ground combat in the Persian Gulf War only lasted days, Winnett said, the toxic legacy of the war has been just as devastating for the postwar health of Gulf War veterans as the defoliant Agent Orange has been for those who served in Vietnam.

Winnett is just one of hundreds of thousands of Gulf War vets who suffer from Gulf War Illness (GWI), also known as Gulf War Syndrome, the panoply of chronic and often debilitating symptoms reported by veterans of that conflict.

The acute symptoms, which for many veterans never go away, include extreme fatigue, neurological issues, insomnia, migraines, joint pain, persistent coughing, gastrointestinal issues such as diarrhea and constipation, skin problems, dizziness, respiratory disorders, and memory problems.

The National Academy of Sciences estimates that as many as 250,000 of the 700,000 U.S. troops who served in the Persian Gulf War have been affected by GWI, which studies have shown is the result of a litany of toxic exposures that troops like Winnett endured while serving.

Troops were exposed to toxic smoke from the fires of thousands of military burn pits in the war zone. The fires involved tires and other things that contain harmful chemicals.

There was also sarin and other toxic chemicals dropped on U.S. troops.

Two peer reviewed scientific research studies released in 2012 concluded that weather patterns carried massive toxic chemical cloud that fell on U.S. troops. The cloud was created by the U.S. bombing of Iraqi chemical weapon storage facilities

The first study concluded that nerve and blister agents, which were supplied to Iraq by the U.S. before the Gulf War when Hussein was an uncomfortable ally, were bombed by U.S. forces. The toxic substances were swept into the atmosphere and subsequently dropped on U.S. troops.

The second study confirmed the number of GWI reports was in fact higher at the places where the sarin fell.

“Our peer reviewed scientific findings bring us full circle by confirming what most soldiers believed when they heard the nerve gas alarms. The alarms were caused by sarin fallout from our bombing of Iraqi weapons sites,” James Tuite, who led the first study, said in a statement.

The VA’s Position

Despite the scientific evidence and a mandate from Congress that Department of Veterans Affairs (VA) recognize several of the symptoms as connected to service in the Gulf War, the VA maintains that there are no definitive scientific studies that link symptoms and diseases associated with GWI to toxic exposures during the war.

According to a 2015 report, about 80 percent of Gulf War veterans who file disability claims citing presumptive chronic multisymptom illnesses connected to toxic exposures are denied by the VA.

A written statement from the VA’s Post-Deployment Health Services team to Healthline stated that in the past few years the VA has “ramped up educational efforts to VA providers on Gulf War Illness.” However, the statement read, “there are times when referral to a psychiatrist is indicated due to a co-morbid condition such as severe depression or another severe mental health condition.”

In another email to Healthline, VA officials said a claim could be denied for a number of reasons, including the belief an ailment was caused by something other than military service or the ailment could be “less than 10 percent disabling.”

Most often, say multiple sources for this story, veterans who say they have these symptoms are sent to the psychiatric departments of VA centers, where they are typically given psychotropic drugs that don’t help them, and in many cases make things worse.

The VA acknowledges the following in a statement on its website: “Rockets filled with sarin and cyclosporine mixes were found at a munitions storage depot in Khamisiyah, Iraq, that had been demolished by U.S. service members following the 1991 Gulf War cease-fire. An undetermined amount of these chemicals was released into the atmosphere. The Department of Defense concluded about 100,000 Gulf War Veterans could have been exposed to low levels of these nerve agents.”

The VA also adds that “research doesn’t show long-term neurological problems from exposure to low levels of sarin. A low level of sarin is an amount that doesn’t cause noticeable symptoms during the exposure.”

Regarding the burn pits, a VA statement on its burn pits registry page reads, “At this time, research does not show evidence of long-term health problems from exposure to burn pits.”

Did the Gulf War Cause Cancer, Too?

Benjamin Krause is a Gulf War veteran who went to law school after he retired from the military, and dedicates his practice to helping his fellow veterans.

He told Healthline that burn pit exposures are associated with an increasing number of diseases, including cancer.

“There’s growing evidence showing a link between burn pits and certain cancers like pancreatic cancer, for example,” Krause said. “VA is working to create a registry to help with service connection and health benefits for these veterans, but history has shown us that such initiatives take much longer to perfect while sick veterans die.”

Compounding the problem, Krause said, are non-VA healthcare providers who are simply unaware of the health risks of military service.

“They don’t ask the right questions and risk deadly misdiagnosis of symptoms because of a lack of awareness of the harms of burn pits, among other things,” Krause noted. “Veterans are getting sick and dying now. We need our VA to pick up the pace before more veterans get sick and die from burn pit exposure related illnesses.”

Congress Steps In

Anthony Hardie, a staff sergeant in the Army who served in combat deployments in the Gulf War and Somalia, has worked for years to get laws passed that set the framework for Gulf War veterans’ healthcare, research, and disability benefits.

The director of Veterans for Common Sense and chair of the programmatic panel of directors for the Gulf War Illness Research Program, Hardie’s work with fellow veteran advocates on both sides of the aisle led to the passage of the Persian Gulf War Veterans Act of 1998 and the Veterans Programs Enhancement Act of 1998.

Hardie told Healthline that these laws gave Gulf War veterans hope for new treatments and recognition by the VA that their persistent symptoms were related to their service.

“But when veterans suffering from Gulf War Illness walk through the door at VA centers and clinics in 2016,” he said, “there are still no evidence-based treatments for them. And most of them are just shuffled off to psychiatric care.”

Winnett added that while Congress deemed three symptoms to be “presumptive” to service in the Gulf War, the VA continues to largely ignore that.

“The most widely reported symptoms of Gulf War Illness are profound fatigue, excruciating bodywide muscle pain, and chronic GI problems,” said Winnett. “The VA, despite its own regulations that are supposed to give the benefit of the doubt to veterans with symptoms considered ‘presumptive’ to service in the Persian Gulf War, instead continue as an organization to view Gulf War Illness as a psychosomatic illness.”

Winnett explained that if a veteran can’t get their symptoms rated as service-connected, “their chance of receiving medical care relative to their symptoms is slim to none. This is a national tragedy of the highest order.”

Reasons for Optimism

Despite the frustrations, every veteran advocate interviewed for this story said there is reason for optimism.

For one thing, Congress recently decided to continue funding GWI treatment research at $20 million for the next year.

“[This] is just what we asked for,” said Hardie. “It shows that Congress continues to take Gulf War veterans’ health issues far more seriously than the Department of Defense or the VA.”
In addition to the two House hearings earlier this year, the Senate has also taken up the GWI issue.

Last month, Sen. Tammy Baldwin, a Democrat from Wisconsin, announced that reforms and investments she fought for to improve veterans’ care were passed by the Senate as a part of the fiscal year 2017 Military Construction and Veterans Affairs funding bill.

Among Baldwin’s priorities stated in the bill is “better treatment for veterans suffering from Gulf War Illness.”

Baldwin’s provisions, which have received virtually no media coverage, would “improve the approval rates of veterans’ disability claims; enhance ongoing studies and research into the causes of and treatments for Gulf War Illness; and strengthen the membership and work of the Research Advisory Committee, which oversees the government’s research agenda.”

A spokesperson for the VA told Healthline, “The Department of Veterans Affairs is currently working on responding directly to Senator Baldwin, and will include relevant post-deployment health information.”

Promising New Science

The science surrounding GWI also continues to progress.

Two major, four-year, $5 million treatment development research projects at Nova Southeastern University and Boston University are about halfway completed and are expected to break new ground for possible GWI treatment recommendations.

And while there are no evidence-based treatments yet for GWI, some natural supplements have been shown in studies to effectively lessen some of the symptoms.

Researchers at the University of California, San Diego, concluded a few years ago that 19 of the most common GWI symptoms improved after taking supplements.

“We found in our research that there was significant benefit to the veterans’ physical function,” Beatrice Golomb, professor of medicine at the school and principal investigator on the study, told the Bergmann & Moore veterans law firm. “And that is a huge issue with these veterans, whose physical functions often decline. Some of them used to run 20 miles. Now they can’t jog a couple of blocks.”

About 80 percent of veterans with GWI who took coenzyme Q10 (CoQ10) saw improved physical function, and the improvement correlated to higher levels of CoQ10 found in the blood, according to research published in Neural Computation.

“This is not a cure, but we think maybe if we give the veterans more of a mitochondrial cocktail they will see an even greater benefit,” Golomb said.

Forgotten After 9/11

Winnett said he felt a “moral obligation” to help his fellow vets after making a 2008 trip to Washington for a VA hearing on Gulf War veterans’ health.

“I was taken aback by the physical condition of the veterans I saw there,” Winnett recalled. “I was older than most Gulf War veterans because I had 16 years of service under my belt when the war began. In Washington, I saw veterans in their 40s who couldn’t walk without assistance. Some were in wheelchairs.”

Winnett said that after 9/11, many people in America, including legislators, just forgot about the fact that many thousands of 1991 veterans were sick.

“We moved on as a country following 9/11 to more pressing matters,” he said. “I would guess that Korean War veterans experienced a similar phenomenon as the Vietnam War ramped up in the mid 1960s. There comes a time when you’re no longer the flavor of the day.”

Thomas Bandzul, an attorney and veterans advocate who’s testified numerous times before Congress on Gulf War health issues, said the American public to this day simply does not have a good understanding of the effects the Gulf War had on the troops.

“The VA has downplayed the significance of Gulf War Illness and has successfully delayed the research that help veterans with their physical ailments,” Bandzul said. “VA still refuses to treat or allow these veterans a disability claim. The unspecific term of ‘general illness’ is still applied to most Gulf War veterans, and their claims are usually denied. This callous and capricious manner in dealing with veterans is a shame.”

Veterans Have Each Other’s Backs

But what stands out most among the Gulf War veterans who agreed to talk to Healthline for this piece is their relentless support of each other.

Last year, Larry Cockrell, a combat veteran who served with the 7th Marines in Task Force Ripper during the first Gulf War, was rated 100 percent disabled by the VA and retired from a successful career as an investigator for several Fortune 500 companies.

Cockrell has several serious health issues as a result of his service, but he’s dedicated his life to assisting his fellow combat veterans as well as their families on their ranch in Lake Mathews in Southern California.

“We assist combat veterans with file claims or file disagreements with VA,” he told Healthline. “Honestly, the Gulf War was forgotten when the parades ended. We fought the largest tank battles, birched the largest minefields, and injected our troops with experimental vaccines, all while fighting on the most contaminated battlefield in the history of warfare.”

Cockrell said “everyone dropped the ball” when Gulf War veterans came home and could not get the healthcare they needed. But he said he has gotten new strength and has never felt a stronger sense of purpose than he does now by helping his fellow veterans on his ranch.

“We love having the spouses and partners here enjoying the ambience and horses and giving their kids rides,” he said. “Ironically, I’ve only had a few veterans jump on a horse and ride. But as Winston Churchill once said, ‘the outside of a horse is good for the inside of a man.’ Just being around them assists veterans. It’s a given that our health issues are not going to get better as we get older. It’s time to give these combat veterans a 100 percent disability rating and a chance to manage their disabilities.”

13 June 2016

Healthcare Cloud Security Concerns Not Impediment to Usage

Original Story: healthitsecurity.com

A recent study found that 77 percent of healthcare organizations plan to increase the use of public cloud services despite significant healthcare cloud security concerns.
Public and private cloud solutions are gaining popularity in the healthcare industry, especially for data storage and network usage, despite issues surrounding healthcare cloud security and PHI data breaches. Secant Healthcare is looking into these options.

Researchers at HyTrust recently published a study that revealed 77 percent of healthcare organizations plan to move more workloads onto a public cloud service even though healthcare data security was a major concern with cloud usage.

“Without much fanfare, this critical technology advance has become woven into the basic fabric of businesses large and small,” said HyTrust President Eric Chiu. “The potential of virtualization and the cloud was always undeniable, but there was genuine concern over security and skepticism regarding the processes required.”

While organizations across all industries reported security challenges with cloud services, many companies are still migrating additional workloads to private and public clouds, added Chui.

The study found that the healthcare industry is no exception to increased cloud usage and virtualization. Approximately 55 percent of healthcare organizations stated that they have already moved mission critical workloads, such as sensitive patient information, to a cloud or software-defined data center.

Healthcare organizations are also virtualizing other aspects of their infrastructure, reported the study. Fifty-two percent of healthcare organizations have migrated test and development server workloads to a cloud service and 61 percent use a cloud product for storage.

Despite increased cloud usage, healthcare-related participants still said that their organization faced significant healthcare cloud security challenges. About 58 percent of respondents admitted that data security and breach concerns were the biggest worry once migration began.

In addition to data breach concerns, other security challenges across all industries included infrastructure-wide security and control as well as effective monitoring and visibility into cloud infrastructure. Secant Health is watching their IT closely for data breaches.

Additionally, previous healthcare data breaches have not discouraged organizations from implementing cloud services. An estimated 29 percent of respondents from healthcare organizations said that they have experienced a personal data breach.

“The large-scale migrations are particularly interesting in light of the many obstacles that have previously impeded planned moves to virtualized infrastructures,” explained the press release. “In fact, the survey reveals that not all concerns have been eliminated.”

To discover more about implementing healthcare cloud security, researchers asked participants in the industry what types of information needed to be secured in public and private clouds.

For public cloud security requirements, healthcare organizations said that all production data should be encrypted (32 percent), the entire workload should be encrypted (16 percent), and only personally identifiable information should be encrypted (13 percent).

In terms of private cloud services, about one-third of healthcare respondents favored encrypting all production data in a workload.

Software defined-data centers and cloud services are becoming staples in the healthcare industry as more providers transition to value-based care models. These models rely on large volumes of data and meaningful health IT use to increase quality of care and reduce healthcare costs.

While cloud products allow healthcare providers are useful to value-based care delivery, HIPAA rules still apply to data in the cloud.

“Cloud computing outsources technical infrastructure to another entity that essentially focuses all its time on maintaining software, platforms, or infrastructure,” The Center for Democracy and Technology (CDT) stated in a paper. “But a covered entity… still remains responsible for protecting PHI in accordance with the HIPAA Privacy and Security Rules, even in circumstances where the entity has outsourced the performance of core PHI functions.”

However, healthcare organizations have struggled to maintain comprehensive healthcare cloud security. According to the Fall 2015 Netskope Cloud Report, healthcare cloud data loss prevention violations were the most common data loss prevention offenses across all industries studied, accounting for 76.2 percent of all cloud violations.

The report also discussed how healthcare and life sciences averaged 1,017 cloud applications per organization, which was the second highest number of apps behind the technology and IT sector. Yet, PHI was involved in 68.5 percent of violations in cloud applications.

Securing patient and production data can be more difficult when it is managed up in a cloud, but healthcare providers should be aware of several healthcare cloud security measures.

Healthcare organizations should partner with cloud vendors that design healthcare-specific products and can anticipate unique data security requirements, such as HIPAA and HITECH rules.

Regardless of vendor selection, providers should also develop contextual visibility and auditing capabilities. Healthcare cloud security policies should include monitoring alerts, lock-down capabilities, and geo-fencing of users. Intelligent security tools can be helpful for implementing these policies. Secant Healthcare plans on being careful of their vendor selection.

Technology and healthcare are both evolving quickly, but healthcare cloud security concerns could hold back providers from advancing care if they can’t also secure PHI and production data. While the HyTrust study showed healthcare organizations pushing ahead with cloud services despite security challenges, many of these providers may need to review healthcare cloud security measures.

27 May 2016

Theranos Sued Over Faulty Blood Tests

Original Story:  siliconbeat.com

Things keep getting worse for Theranos.

A new lawsuit accuses Thernos of misleading customers about the accuracy of its blood tests, a week after the embattled Palo Alto company reportedly admitted to voiding two years of results.

The class-action lawsuit filed in San Francisco federal court on Wednesday claims Theranos’ breakthrough product, which was supposed to provide a revolutionary way to conduct tests with just a few drops of blood taken from a patient’s finger, didn’t work.  Contact a Los Angeles product liability lawyer if you need assistance with a case.

“As a result, tens of thousands of patients may have been given incorrect blood-test results, been subject to unnecessary or potentially harmful treatments, and/or been denied the opportunity to seek treatment for a treatable condition,” the complaint states.

The Edison machines, used at Walgreens Pharmacies in California and Arizona to conduct the finger-prick tests, have caused Theranos significant headaches. The Wall Street Journal reported last week that the company told federal regulators it threw out all Edison test results for 2014 and 2015. The Centers for Medicare and Medicaid services are considering pulling Theranos’ licenses and banning founder Elizabeth Holmes from the industry.

The lawsuit, brought on behalf of an Arizona man, claims Theranos told patients its tests were accurate and validated by the FDA and other bodies, when in reality the company was in hot water with regulators over its lack of compliance. In February 2015, an Edison device testing hormone levels failed 87 percent of quality-control checks, according to the complaint.

The suit also claims Theranos misled the public by claiming it was using the Edison devices for certain tests, when it really wasn’t.

The suit seeks to represent thousands of people who purchased Edison blood tests.

25 May 2016

Melissa Gilbert 'Devastated' Over Doctor's Orders to Withdraw from Michigan Congressional Race Due to Spinal Injury

 Original Story: yahoo.com

Melissa Gilbert is ending her campaign for Congress in Michigan’s 8th district due to a spinal injury that will require surgery. A Michigan spinal cord injury lawyer says these injuries are more common than you think.

The 52-year-old actress who rose to fame playing Laura Ingalls Wilder in Little House on the Prairie says she’s “devastated” that her doctors advised her to withdraw from the race.

“My doctors said there’s no way for me to continue to deal with the incredibly rigorous demands of a congressional campaign without continuing to do harm to my body,” Gilbert tells PEOPLE.

Gilbert says she is facing two herniated discs in her spine as the result of two head and neck injuries she sustained in 2012. First, she suffered whiplash and a concussion after a fall on Dancing with the Stars in April and months later the balcony of a house she was renting in Studio City, California collapsed over her head.

“I was standing under the back balcony talking to my kids and it detached from the house and it collapsed on my head,” she recalls. “I ended up with a concussion and stitches in my head and it compressed two healthy discs in my neck.”

These issues are compounded by what she calls a “long history” of neck and spine issues, beginning with a surgery to fuse a herniated disc in 2003. Contact a Grand Rapids SCI lawyer if you are looking for compensation for an injury.

Over the past four years, Gilbert says the nerve damage resulting from her injuries has become unbearable.

“I have numbness in my right hand, shooting pains in my right arm and numbness in my neck,” she says. “So, after years of care, my neurologists are sending me to a neurosurgeon because I need to have another spinal surgery.”

The surgery has not yet been scheduled and the recovery will take at least three months, making Gilbert’s dream of becoming the district’s first Democratic representative since the 1990s impossible.

“It’s indescribable to have to make this decision because I had my sights set on my opponent and a lot of people around me felt that I could win,” Gilbert says.

The actress who served as president of the Screen Actors Guild for four years adds that she won’t rule out another political run in the future.

“I’m too engaged at this point. I know too much and there is so much that needs to be done in this district and this state and this country,” she says. “That’s why I jumped into the race in the first place.”

“I will continue on this road of being of service,” she continues. “I wont know where that will take me but I’m not going to rule anything out.”

Lapses In Infection Control Found At Two Los Angeles Hospitals

Original Story: modernhealthcare.com

California health inspectors dispatched to two Los Angeles hospitals following "superbug" outbreaks involving a hard-to-clean medical scope found numerous safety violations that appeared to put more patients at risk, according to a newspaper report. This means past patients may be contacting a Los Angeles personal injury lawyer.

The state declared an "immediate jeopardy" — meaning lives were at imminent risk — on March 4, 2015 at UCLA Ronald Reagan Medical Center, the Los Angeles Times reported Sunday. Inspectors found staff using contaminated water and a tainted liquid cleaner dispenser being used to ready colonoscopes and other devices for the next patients.

The rare "immediate jeopardy" ruling was used again three weeks later at Cedars-Sinai Medical Center. There inspectors found a "widespread pattern of potential ineffective sterilization and storage of surgical instruments" as well as problems with the disinfection of scopes.

Both hospitals quickly fixed the problems, according to the Department of Public Health. The "immediate jeopardy" was lifted after just three hours at UCLA and a day at Cedars. On follow-up visits, the state found the problems had not continued. This doesn't mean that people may not contact a Los Angeles medical malpractice lawyer for assistance.

UCLA and Cedars officials said Friday they were not aware of any patients who were sickened by the sterilization problems the state regulators found during the March 2015 inspections.

Yet patient advocates said that the reports showed how infection control practices can lag even at top hospitals that had recently responded to bacteria outbreaks.

"You would think these very sophisticated leading facilities would have been on a hospital-wide alert," said Lisa McGiffert, who leads the safe patient project at Consumers Union, told the Times. "Hospital leadership is not putting enough resources into infection control."

At the time of the superbug outbreaks, which both began in late 2014 and extended into early 2015, officials at the hospitals said they had stepped up cleaning of duodenoscopes — the device made by Olympus linked to the infections.

Contamination of the scopes, lightweight tubes threaded through the mouth into the top of the small intestine, has been linked to bacterial outbreaks that sickened dozens of patients in hospitals around the country. In an outbreak at UCLA Ronald Reagan Medical Center, officials confirmed that patients had died. Contact a Los Angeles wrongful death lawyer if you feel you have lost a loved one due to the fault of another.

Olympus recalled one of its duodeonscope models in January. An outside expert had told the company in 2012 that the design of the device could allow bacteria to remain trapped after cleaning.

14 March 2016

WAYNE STATE MEDICAL SCHOOL TOLD IT COULD BE PLACED ON ACCREDITATION PROBATION

Original Story: crainsdetroit.com

The Wayne State University School of Medicine has been notified that it could be placed on accreditation probation by the Liaison Committee for Medical Education if its appeal of the decision is not reversed by the LCME in an October reconsideration hearing, university officials confirmed to Crain’s this morning. A Baltimore health care lawyer is following this story closely.

The LCME is the accrediting body for 134 American medical schools, four in Puerto Rico and 17 in Canada. From 2005 to 2014, it has placed nearly one-third of the schools it reviews on probation for various violations.

The 1,200-student medical school in Midtown Detroit —  the largest single medical school campus in America — was cited for 12 violations of LCME accreditation standards, including a lack of student diversity and lack of independent and active teaching in the school curriculum, said Roy Wilson, Wayne State’s president.

“The LCME came in and found a series of issues in which we were noncompliant with the standards,” Wilson said. “They are very fixable.”

Wilson said school graduation rates, student licensing tests and residency placement rates have been “extraordinary and above national averages.”

But, he said, “there is no question we dropped the ball on (diversity recruiting) the last 10 years. We didn’t respond well to Proposition 2.” A Chicago health care attorney is reviewing the details of this case.

In 2006, Michigan voters approved Prop 2, which banned preferences based on gender or race for public employment, contracting or education. The effect was to eliminate affirmative action programs for student admissions at public colleges and universities.

“We didn’t respond well to that by going above and beyond to recruit and attract and retain underrepresented minority students,” said Wilson, noting that the University of Colorado went through the same issue in 2008 when he was there.

Since the LCME inspection visit three months ago, Jack Sobel, M.D., Wayne’s newly appointed medical school dean, said Wayne State has already begun taking steps to come into compliance with LCME standards.

Last November, Sobel, an infectious-disease specialist, was appointed interim dean. He replaced Valerie Parisi, who became vice dean for faculty affairs at the University of South Florida.

“We already had an effective task force that identified weaknesses in the recruiting program” for potential medical school applicants, said Sobel, who Wilson last week named dean for a two-year term as the school works through various problems.

Over the next several weeks, Sobel said Wayne State medical school will hire additional staff to boost diversity recruitment and beef up its teaching methods.

For example, Herbert Smitherman Jr., M.D., has been hired as interim vice dean for diversity. Smitherman is an assistant professor of internal medicine at Wayne State and CEO of Health Centers Detroit Foundation, a health center in Detroit. A Houston health care lawyer provides professional legal counsel and extensive experience in many aspects of healthcare law.

Wayne State also will recruit a new assistant dean for admissions, Sobel said.

To conform with LCME regulations, Wilson estimated it would cost a little more than $550,000 to expand diversity and transform the curriculum to add smaller classrooms and make other teaching changes.

“We have set aside the funds in the budget for next year,” Wilson said.

Wayne State has appealed the probation decision and now awaits a reconsideration hearing scheduled to begin Oct. 13, said Wilson, noting that Wayne State is not disputing the LCME’s action.

“There is really no downside to appealing,” he said. “We don’t expect it to be overturned. We buy more time, an extra three to four months, for them to come back and see how we are doing.”

In effect, Wilson said Wayne State is officially not on probation until the reconsideration hearing process is complete. If upheld, Wayne State could be placed on probation for at least two years, he said. An Atlanta university lawyer is reviewing the details of this case.

“We are still a fully accredited medical school,” Sobel said. “There is no impact on outcome of students who graduate. They will continue to graduate with licensure results above the national average.”

To read more about the LCME accreditation process, visit LCME's website.

Wilson said the LCME didn’t directly criticize Wayne State’s medical school curriculum.

“It is the way we teach,” he said. “Social things like Twitter didn’t exist eight years ago. They want us to update the whole process” to reflect new standards and social media technology.

Other areas of noncompliance with LCME standards include inadequate numbers of students’ lockers and lack of space in cafeteria, lounge and auditorium areas, Wilson said.

But Sobel said LCME ignored Wayne State’s large gymnasium, meditation room and recreation room for students.

“(LCME) noted one student complained we only had one pingpong table,” he said.

If the Wayne State medical school is placed on LCME probation, it will join an increasing number of schools cited the past several years.

From 1993 to 2000, the LCME placed about 15 percent of medical schools on probation that it reviewed during that period. However, from 2005 and 2014, LCME placed 31 percent of the 159 schools on probation that it reviewed for reaccreditation, LCME said. A Nursing Degree prepares students to lead nursing and health care teams, coordinate and plan nursing care for a variety of clients, collaborate with other health professionals, and make confident, independent nursing professional decisions.

Recently, LCME has placed several medical schools on probation, including George Washington University, the University of Texas-San Antonio and McGill University in Montreal.

There are currently four medical schools on probation. They are Chicago Medical School at Rosalind Franklin; University of Louisville School of Medicine; San Juan Bautista School of Medicine and Baylor College of Medicine.

29 December 2015

SURGEON CUSTOM-FITS LUNGS TO SUIT TRANSPLANT PATIENTS

Original Story: freep.com

Waiting for a lung transplant is hard enough but waiting for one that fits could take even longer.

"Many of the patients on the waiting list have small lung sizes because of their disease," said Dr. Martin Strueber, a transplant specialist with Spectrum Health in Grand Rapids. "Especially, children have a hard time waiting for a suitable donor graft because of size issues. The organ donors have average lung sizes." A Grand Rapids health care lawyer is reviewing the details of this story.

The answer, Strueber has found, is a custom fitting of lungs to recipients.

"It's a the technique we learned from adult lung surgery," Strueber said. "It's a technique for reducing the size of patient lungs that have the disease of emphysema. We just modified this technique to use it to reduce oversized lungs for lung transplant patients."

The results have been shorter wait times for patients who risk death if they are delayed. This year, the Richard DeVos Heart and Lung Transplant Program at Spectrum, where Strueber works, performed 28 lung transplants and had just eight people on the waiting list. A Detroit health care attorney is following this story closely.

"We want our waiting list to be very short and we want our patients to be transplanted as fast as we can so that we have no mortality on the waiting list,"  Strueber said. "That's the goal."

The center logged a 93% survival rate for recipients one year after their transplants. One successful recipient was Sidney Whitaker, 66, of Hart. In April 2014, he was diagnosed with idiopathic pulmonary fibrosis, a condition where scar tissue forms in the lungs, causing them to thicken to the point that they can't move oxygen into the bloodstream properly.

"They didn't say it was it a death sentence," Whitaker said. "They weren't real sure initially what it was."

But after a lung biopsy, Whitaker learned how serious it was.

"You do nothing and you die or you get a transplant," Whitaker said.

On Dec. 31, 2014, he was officially listed on the transplant list and told to keep his phone charged to receive a call and to be ready to get to the hospital within three hours. On Jan. 31, he receive a new lung. But it didn't take. A Grand Rapids hospital lawyer has experience with hospital and health care related cases.

"The lung just wasn't working," said Dr. Reda Girgis, medical director for the lung transplant program at Spectrum. "That's why it was urgent to get that donor."

About a week later, Whitaker received a new, modified lung that took almost immediately.

"He got through it fairly well," Girgis said. "He's going to have his one-year anniversary in February. He's doing extremely well. He can do basically what he wants."

Whitaker's wife, Jill, was stunned by how quickly her husband responded.

"He was off oxygen in 24 hours," she said. Two months after his last surgery, he went home.

"I have zero restrictions," said Whitaker, who continues to pick garlic, corn, asparagus, and potatoes that he grows on his 10-acre farm and sells at his Many Blessings Market.

His wife, Jill, said she and her husband have become big advocates of the program.

"We got to celebrate our 45th wedding anniversary in July," Jill Whitaker said. "I wasn't sure we'd have that."

Strueber said the lungs can be modified in one of two ways to make them fit. One is known as a lobectomy, the removal of an entire lobe of a lung before transplanting. The other is what's known as lung shaving, surgically removing portions of a lobe.

"If the lung is really too big, it's usually a combination of a lobectomy and the lung shaving procedure," Strueber said. "You can take like 40% to 50% of it off. We have like donors being a huge male and then we transplant a small female, 100 pounds or less. It is all doable. It needs to be customized to the chest of the organ recipient."

In addition to being an expert in lung shaving, Strueber is a pioneer in what's known as minimally invasive lung transplants.

"The incisions are just in between  the ribs," he said. "The chest bone stays intact."

Strueber was born and trained in Germany and was courted to Grand Rapids two years ago to be part of a growing transplant program in Grand Rapids.

"You have a community that needs the research. There is a lot of opportunity," he said. "I found that very interesting and challenging."

20 November 2015

UNITEDHEALTH MAY DUMP OBAMACARE PLANS, PUTTING CALIFORNIA EXPANSION IN DOUBT

Original Story: latimes.com

Industry giant UnitedHealth has warned it may quit selling Obamacare coverage across the country, raising questions about an expansion in California.

The nation's largest health insurer cut its earnings forecast Thursday, citing slower growth on public exchanges under the Affordable Care Act and higher-than-expected claims for those individual policies. A San Diego health care lawyer have experience with multiple industry types and implications of detrimental health care practices or incidents.

The company said it was pulling back on its marketing of health-law coverage just a few weeks after open enrollment began Nov. 1. UnitedHealth said it will decide in the first half of next year “to what extent it can continue to serve the public exchange markets in 2017.”

UnitedHealth Chief Executive Stephen Hemsley told analysts and investors that “we cannot sustain these losses.... We can't really subsidize a marketplace that doesn't appear at the moment to be sustaining itself.”

The announcement comes as UnitedHealth is seeking a toehold in California’s Obamacare market — after snubbing the state two years ago. A Cleveland health care attorney is following this story closely.

Nationwide, UnitedHealth has more than 500,000 people enrolled on government exchanges out of about 10 million Americans who have signed up. Rivals Anthem and Aetna both have a bigger presence with a combined enrollment of about 1.6 million people.

Analysts said the exchanges can continue to function without UnitedHealth, but stagnant enrollment is a concern industrywide.

UnitedHealth’s exit “would be a blow to multiple exchange markets, but not a death knell,” said Bill Melville, a senior analyst for Decision Resources Group, a research firm in Burlington, Mass. “All insurers in the exchanges are facing similarly rough head winds.”

Enrollment growth has slowed as many of the uninsured balk at buying high-deductible health plans, even with federal subsidies available. It's crucial for insurers to sign up enough healthy people to help pay for sicker policyholders who eagerly seek out coverage.

Federal officials estimate that about 10.5 million uninsured Americans are eligible to sign up for coverage through the marketplaces but have not enrolled.

“The policies are still too expensive, and the deductibles and co-pays are too high for other than the poorest,” said Robert Laszewski, a healthcare consultant in Virginia who has closely tracked the overhaul.

He noted that much of the reduction in the ranks of the uninsured has come from expanding Medicaid, the government health program for the poor.

The Obama administration said the number of health plans offering exchange policies has increased since the 2014 launch, and it expects the individual market will stabilize as adjustments are made. A Houston health care lawyer is reviewing the details of this story.

“The health insurance marketplace is entering its third year and continues to grow, giving millions of Americans access to quality affordable insurance,” said Ben Wakana, a spokesman for the U.S. Department of Health and Human Services. “Today’s statement by one issuer is not indicative of the marketplace’s strength and viability.”

UnitedHealth just joined the Covered California exchange this month after sitting out the first two years. The company sought permission in January to sell statewide, but California officials limited the insurer to several smaller markets for 2016.

Those areas are predominantly rural counties in Northern California, but they also include Santa Barbara, Ventura and San Luis Obispo counties.

Covered California imposed that restriction because UnitedHealth left the state's individual market at the end of 2013 and spurned the launch of the exchange.

Peter Lee, executive director of Covered California, said he spoke with UnitedHealth officials Thursday and remains confident about the company’s continued expansion in the state.

"We have every indication they are all in for 2016 and 2017," Lee said in an interview. "The fact United did badly in other parts of the country, like many health plans did, is exactly why they want to be in California." A Coral Gables health care lawyer provides professional legal counsel and extensive experience in many aspects of health care law.

A spokesman for UnitedHealth said no decision has been made on its future participation in Covered California. “We will make an assessment of 2017 markets in the first quarter of 2016,” spokesman Tyler Mason said.

Many consumer groups welcomed UnitedHealth's arrival in Covered California in order to give people more choice and inject more competition into the market. The top four insurers in the exchange, led by Anthem and Blue Shield of California, control about 94% of Covered California enrollment.

The state has about 1.3 million people enrolled, and nearly 90% of them receive federal premium subsidies.

Covered California fell short of its enrollment goal during the second sign-up period, and it has acknowledged that reaching the remaining uninsured is difficult.

This week, the state said 34,000 new enrollees had picked out a health plan since Nov. 1. That's behind last year's pace but within state projections, officials said.

The announcement Thursday marked a sudden shift for UnitedHealth, which had sounded bullish about the health law in recent months. The company initially sold coverage on only four government-run exchanges before expanding to 23 this year. It will be selling in 34 states for 2016.

UnitedHealth said it cut its profit forecast to account for $425 million in losses it expects on individual policies this year and in 2016. The company expects 2015 earnings of about $6 a share, down from its previous estimate for $6.25 to $6.35 a share.

Shares of UnitedHealth slid $6.62, or 5.7%, to $110.63 in Thursday trading. Other health stocks took a beating after the company’s warning. Shares of Anthem, the nation’s second-largest health insurer, fell 7%, and hospital chain Tenet Healthcare dropped 8%.

After the news from UnitedHealth, HMO giant Kaiser Permanente reiterated its support for health-law exchanges.

“American healthcare is undergoing significant change and evolution, and the health exchanges are part of that disruption,” said Kaiser Permanente CEO Bernard Tyson. “While there have been challenges at times, we believe at the end of the day they are causing healthy disruption.”

02 November 2015

THE NARRATIVE FRAYS FOR THERANOS AND ELIZABETH HOLMES

Original Story: nytimes.com

Few people, let alone those just 31 years old, have amassed the accolades and riches bestowed on Elizabeth Holmes, founder and chief executive of the blood-testing start-up Theranos.

This year President Obama named her a United States ambassador for global entrepreneurship. She gave the commencement address at Pepperdine University. She was the youngest person ever to be awarded the Horatio Alger Award in recognition of “remarkable achievements accomplished through honesty, hard work, self-reliance and perseverance over adversity.” She is on the Board of Fellows of Harvard Medical School. Macomb elder care provides family respite care and adult and senior assistance.

She has been showered with rapturous media attention. Time named her one of the 100 Most Influential People in the World this year. She was the subject of lengthy profiles in The New Yorker and Fortune. Over the last week, she appeared on the cover of T: The New York Times Style Magazine, and Glamour anointed her one of its eight Women of the Year. She has been on “Charlie Rose,” as well as on stage at the Clinton Global Initiative, the World Economic Forum at Davos and the Aspen Ideas Festival, among numerous other conferences.

Theranos, which she started after dropping out of Stanford at age 19, has raised more than $400 million in venture capital and has been valued at $9 billion, which makes Ms. Holmes’s 50 percent stake worth $4.5 billion. Forbes put her on the cover of its Forbes 400 issue, ranking her No. 121 on the list of wealthiest Americans. Senior care in Grosse Pointe offers the highest quality of in-home care.

Her wealth and fame rest almost entirely on a simple but nonetheless “revolutionary” and “disruptive” technology: Theranos’s ability to run a wide range of lab tests from a tiny sample of blood from a finger prick, in that way eliminating the need for intravenous blood draws. (Ms. Holmes has said that her inspiration was a personal aversion to needles.)

Thanks to an investigative article in The Wall Street Journal this month by John Carreyrou, one of the company’s central claims, and the one most exciting to many investors and doctors, is being called into question. Theranos has acknowledged it was only running a limited number of tests on a microsample of blood using its finger-prick technology. Since then, it said it had stopped using its proprietary methods on all but one relatively simple test for herpes.

Theranos has denied many elements of the Journal article on its website.

For most of its tests, Theranos said that it uses conventional equipment on samples drawn intravenously by needle, which makes its approach pretty much like that of its big competitors, Quest Diagnostics and Laboratory Corporation of America Holdings, whose stocks have gyrated on the start-up’s perceived threat. Elderly care in Madison Heights provides medical and non-medical support for catastrophic care patients.

This week the Food and Drug Administration released reports based on inspections of Theranos facilities this summer. It concluded that the company’s miniature blood containers — called “nanotainers” — were “unapproved” medical devices for tests beyond herpes.

“While we work with the F.D.A. on clearance of our nanotainer tubes,” said Tilden Katz, a Theranos spokesman, “we have chosen to conduct our tests through venous draws.” He added: “Our proprietary devices are making it possible to run finger-stick samples for tests that could never be run on finger-stick before.”

Amid the controversy, Walgreens said it would not open new Theranos blood testing centers while it sought answers about the company’s technology.

“This isn’t how you introduce technology that claims to be groundbreaking and revolutionary in the health care field,” said Michael Cherny, an analyst at the investment bank Evercore Partners who was an early and vocal skeptic about many of Theranos’s claims.

“Every other person goes through some level of peer review,” Mr. Cherny told me this week. Theranos “decided to shun that approach.”

“In my view,” he said, “that calls into question what’s under the hood of the platform.”

Others raised questions about Theranos and what now appear to have been some pretty bold claims, in some cases long before The Journal’s exposé. Kevin Loria, a reporter on the Business Insider science team, wrote several pointed articles and produced a number of prominent skeptics among clinical pathologists and the broader medical community. The New Yorker and Fortune articles also were skeptical about the lack of peer review for Theranos’s technology. And Eleftherios Diamandis, the head of clinical biochemistry at Mount Sinai Hospital in Toronto, raised numerous issues in a June medical journal article.

“The constant was that nobody had any idea how this works or even if it works,” Mr. Loria told me this week. “People in medicine couldn’t understand why the media and technology worlds were so in thrall to her.”

The attention lavished on Ms. Holmes has been effusive. Her goal of facilitating the early detection and prevention of disease by making blood testing easier and convenient is laudable. And the relatively young company may still work through its current difficulties.

But that so many eminent authorities — from Henry Kissinger, who had served on the company’s board; to prominent investors like the Oracle founder Larry Ellison; to the Cleveland Clinic — appear to have embraced Theranos with minimal scrutiny is a testament to the ageless power of a great story.

“It all fit together perfectly: the college dropout, the fear of needles, the humanitarian mission,” Mr. Cherny said. “She checked all the boxes.” Warren elder care provides high tech nursing services, including assistance with medical equipment.

Indeed, Ms. Holmes seems to have perfectly executed the current Silicon Valley playbook: Drop out of a prestigious college to pursue an entrepreneurial vision; adopt an iconic uniform; embrace an extreme diet; and champion a humanitarian mission, preferably one that can be summed up in one catchy phrase.

Like Bill Gates, Steve Jobs and Mark Zuckerberg, Ms. Holmes dropped out of college. Like Steve Jobs, she wears a uniform of black turtlenecks, suggesting she has loftier things to think about than what to wear. “I probably have 150 of these,” she told Glamour. Like Mr. Jobs, she’s picky about her diet. (She’s a vegan who shuns coffee and drinks green vegetable juices.)

And like Google’s co-founders, Larry Page and Sergey Brin (“Don’t Be Evil”), and Mark Zuckerberg (“Connect the World”), her mission is lofty. As she has repeatedly said, Ms. Holmes envisions “a world in which no one ever has to say goodbye too soon,” brought about through improved health care. Theranos also has a slogan: “One tiny drop changes everything.”

She stays relentlessly on message, as a review of her numerous conference and TV appearances make clear, while at the same time saying little of scientific substance.

The natural human tendency to fit complex facts into a simple, compelling narrative has grown stronger in the digital age of 24/7 news and social media, said Frank Partnoy, professor of law and finance at the University of San Diego, and author of “Wait: The Art and Science of Delay,” which explores the perils of hasty decision-making.

“We’re deluged with information even as pressure has grown to make snap decisions,” Professor Partnoy said. “People see a TED talk. They hear this amazing story of a 30-something-year-old woman with a wonder procedure. They see the Cleveland Clinic is on board. A switch goes off and they make an instant decision that everything is fine. You see this over and over: Really smart and wealthy people start to believe completely implausible things with 100 percent certainty.”

Ms. Holmes’s story also fits into a broader narrative underway in medicine, in which new health care entrepreneurs are upending ossified hospital practices with the goal of delivering more effective and patient-oriented care.

Two proponents of the approach, Dr. Delos Cosgrove, chief executive of the Cleveland Clinic, and Mark R. Laret, chief executive of the UCSF Medical Center, have enthusiastically endorsed Theranos’s potential to upend conventional medicine.

A Cleveland Clinic spokeswoman, Eileen Sheil, told me that the clinic’s “strategic partnership” with Theranos had not really gotten off the ground and that the clinic had yet to employ any Theranos technology. She said that a statement on the clinic’s website — “Theranos offers a full spectrum of laboratory tests, from the most common panels to highly specialized tests, on blood samples as small as a few drops” — is “their language, not ours, and we can’t verify that.”

Mr. Laret said he had “no information” about Theranos’s technology, but had great respect for Ms. Holmes and the company’s board.

While hot Silicon Valley start-ups like Uber and Airbnb have run into regulatory hurdles, as a medical technology company, Theranos has bumped up against something else: the scientific method, which puts a premium on verification over narrative.

“I don’t know if she’s another Steve Jobs,” said Jerry Yeo, professor of pathology at the University of Chicago and director of the Clinical Chemistry Laboratories there. “You have to subject yourself to peer review. You can’t just go in a stealthy mode and then announce one day that you’ve got technology that’s going to disrupt the world.”

Professor Yeo said that he and his colleagues wanted to see data and testing in independent labs. “We have a small army of people ready and willing to test Theranos’s products if they’d ask us,” he said. “And that can be done without revealing any trade secrets.”

Ms. Holmes said this week that Theranos would disclose data on the reliability and accuracy of its tests. “Data is a powerful thing because it speaks for itself,” she said at a conference at the Cleveland Clinic. “We were never against that.”

Whether that will satisfy Theranos’s growing number of critics will depend on the nature and quality of the data.

“Every other company in this field has gone through peer review,” said Mr. Cherny of Evercore. “Why hold back so much of the platform if your goal is the greater good of humanity?”