Thursday, June 27, 2013

State fines Kaiser $4 million for mental health violations

The California Department of Managed Health Care ignores almost all complaints from Kaiser patients, but this complaint came from Kaiser providers, so the DOMHC couldn't look the other way.California officials have fined healthcare giant Kaiser Permanente $4 million for problems related to patient access to mental health services.

State fines Kaiser $4 million for mental health violations
The California Department of Managed Health Care fined Kaiser Permanente $4 million Tuesday related to problems it found with patient access to mental health care.
Los Angeles Times
By Chad Terhune
June 25, 2013

California officials have fined healthcare giant Kaiser Permanente $4 million for problems related to patient access to mental health services.

The fine announced Tuesday stems from deficiencies the California Department of Managed Health Care identified in March that were found during a routine medical survey. This marks the agency's second-largest enforcement action after a $10 million fine against Anthem Blue Cross in 2008 related to improper policyholder cancellations.

"The Department's actions are a result of both the seriousness of the deficiencies and the failure of Kaiser to promptly correct them," said Brent Barnhart, director of the Department of Managed Health Care.

"The Department is taking this action to ensure that Kaiser promptly corrects these deficiencies and provides its patients with the mental healthcare promised to them by their health plan," Barnhart added.

State officials said Kaiser's problems covered a variety of issues affecting patients. It found that Kaiser needed to better track and monitor the availability of providers.

The health plan needs to ensure that appointments are offered in a timely manner and improvements to care are made when deficiencies are identified, according to the state investigation.

Regulators also said that Kaiser's educational materials and its "frequently asked questions" included inaccurate information that could dissuade a patient from seeking care.

John Nelson, a spokesman for Kaiser, said each of the state's findings "has already been corrected or is very far along toward resolution."

In light of that, the company said the "amount of the proposed penalty is unwarranted and excessive."

Agency officials said they would conduct a follow-up survey in October to ensure Kaiser has corrected the deficiencies and is complying with the law.

Sunday, June 16, 2013

The Chargers' Doctor Is A Drunk Quack. Why Haven't They Fired Him? Because popularity is more important than competence

The Chargers' Doctor Is A Drunk Quack. Why Haven't They Fired Him?
Barry Petchesky

The California Medical Board believes that David Chao should lose his medical license. Nearly two dozen former patients who have sued him since 1998—alleging in all the medical superfecta of malpractice, personal injury, negligence, and fraud—would agree. Dissenting: the NFL and the San Diego Chargers, for whom Chao has served as team physician for the past 15 years.

The Chao dossier is lengthy. Two drinking-and-driving citations. A DEA investigation. Accusations that he enabled his former partner's prescription-drug habit. Four lawsuits from former Chargers he had treated. In early 2011, reporter Brent Schrotenboer, Chao's most dedicated watchdog, counted 20 lawsuits filed against Chao since 1998, with at least eight of those "settled with payouts to plaintiffs." Another was decided last summer, when Chao was found liable for negligence and fraud in the case of a 15-year-old girl, Whitney Engler, who had been disfigured in the course of Chao's treatment.

As far as the NFL is concerned, all of this is irrelevant. Last year, the NFL Players Association asked the league for a formal review of Chao's history. But the three-man independent panel hearing the case, per the collective-bargaining agreement, was not supposed to take into account the many suits stemming from Chao's private practice, or his own arrests, or even claims of perjury. Quietly, in February, Chao was "totally exonerated" by the panel, which dismissed the medical malpractice suits as irrelevant to "the quality of care that he provides to the San Diego Chargers players."

In recent weeks, we've learned some more supposedly irrelevant things about Chao, a Harvard- and Northwestern-trained orthopedic surgeon. Like a license hearing pursued by an aggressive California attorney general who wants to know why Chao was ordering vodka at a nightclub while one of his patients was losing a leg. Or a medical repair executive who tells us that Chao's MRI machines were outdated, inaccurate, and poorly maintained. Or a San Diego coroner's report that found a prescription sedative in the system of Junior Seau, for whom Chao acted as drinking buddy and personal physician.

NFLPA executive director DeMaurice Smith, in brief remarks before Chao had been exonerated by the panel, said, "It seems to me that the players of the National Football League deserve to have a doctor who's not been found liable of malpractice."

California also thinks its citizens deserve better than Chao. This past July, before the NFL's review, the state medical board filed a formal complaint against him. The board seeks to suspend or revoke his license, citing "repeated negligent acts."

That Chao remains the Chargers' doctor even now, amid a hail of accusations and universally terrible PR for both the team and league, owes less to his ability to treat his patients than to the unresolved conflict at the heart of the modern NFL: How can the league keep players safe and healthy without being legally responsible for the safety and health of the players?

This isn't the first time the state of California has gone after David Chao. In 2002, the medical board fined him for writing Gary Losse's prescriptions. Losse, Chao's former partner, was addicted to prescription painkillers, according to depositions of coworkers. A pharmacy technician testified that Chao regularly wrote the prescriptions and charged them to Losse's personal account. Losse and Chao were sued by former Charger DB Mark Montreuil, who claimed Losse had operated on his knee injury while high. Montreuil never played again, and he reached an out-of-court settlement with the two doctors. According to Losse's longtime nurse, a partner at the clinic told her that in 1998 the Chargers had pressured Losse to step down because of the drug use. Losse would leave the medical field altogether. Chao and another partner inherited his contract with the team, and in 2002 Chao became the sole, official scalpel of the Chargers.

In 2010, drug enforcement agents searched Chao's office after learning of more than 100 prescriptions apparently made out to himself. (The DEA became involved after the arrest of former Charger Kevin Ellison, who was found with a large stash of illegally obtained Vicodin pills.) The investigation was closed two years later, with the DEA saying Chao was not suspected of using the pills himself, and that "with the DEA's guidance, Dr. Chao's controlled substance record keeping is now in compliance."

In 2011, the medical board filed another complaint, to address Chao's two citations for drinking and driving. The second DUI had taken place in 2006, and Chao was accused of failing to disclose it while applying for a license to evaluate worker's compensation claims. (He would be disqualified for the license when it emerged that he had lied on his forms. He "knowingly [made] material misrepresentations under penalty of perjury," according to the director of the state's worker's comp division.)

The complaint revealed that the first thing Chao had told police upon being pulled over was that he worked for the Chargers:

Chao would testify that his blood alcohol content, 0.11, was measured three hours after the last of his two drinks and might have been high due to his Asian genes. Matthew Davis, a California deputy attorney general arguing on behalf of the board, said Chao's testimony "stretches credibility."

In his defense, Chao had himself examined by a board-certified psychiatrist, Stephen Sobel, who reported that Chao did not and does not abuse alcohol. That Sobel has served as the Chargers' "consulting psychiatrist" since 2003 was not brought up.

Davis, in his closing argument, declared that "sound judgment is part and parcel to the qualifications and duties of a physician. The DUI conviction evidences a problem in that area." The judge officially reprimanded Chao, recommending probation, a further psychiatric exam, and ethics training (that decision can be found at the bottom of this page).

The most recent complaint, the one the medical board argues should get Chao's license taken away, cites three negligence cases that took place between 2007 and 2010. One case involved Kathleen Adams, who was crippled by a botched hip replacement and won a $2.2 million payout from Chao. (Chao would later sue the makers of the surgical scissors used in the operation.)

A second patient had dangerous blood loss from "significant blood vessel lacerations" during hip replacement surgery. A third, in for a knee replacement, suffered deep venous thrombosis and a pseudoaneurysm.

The full document, which can be found at bottom, lists the board's executive director, Linda Whitney, as the complainant. It requests a hearing for Chao before the Office of Administrative Hearings, where the state's case will be argued by the attorney general's office—in this case, Matthew Davis. It closes with this request for action:

There are plenty of former patients who aren't cited in the complaint—yet. Like Whitney Engler, a teenage track star left disfigured after undergoing minor knee surgery in 2003. For her recovery, Chao prescribed a controversial cold-therapy device called Polar Care—and did not disclose that he and his company made money by renting it to her.

He'd had trouble with the machine in the past. In 2002, he settled out of court with a SeaWorld performer who had suffered frostbite after using the device. Engler suffered similar pain and tissue damage from the treatment. In her lawsuit, she claimed that Chao had played dumb about the device's history. "I asked him specifically if he knew what could have caused this," she told a reporter, "and he said, 'I don't know, I've never seen anything like this before.'"

On July 31, four days after the state medical board filed its complaint, Engler was awarded more than $12 million in total compensatory and punitive damages, split between the three defendants. (A jury assigned 50 percent of the responsibility for her harm to Chao. The clinic came in for 10 percent; Polar Care's manufacturer, 40 percent.) In the verdict, Chao's legal team was accused of some pretty underhanded tactics:

The [defendants] engaged in a number of ill-conceived strategies to derail the litigation, including hiding the location of witnesses, failing to produce witnesses, and engaging in a clandestine attempt to disqualify [Plaintiff's] counsel. In one such plot, they claimed that they dummied up a letter from Dr. Chao's attorneys, addressed to Dr. Chao, which contained incriminating information, with the idea that it would be leaked by someone to [Plaintiff's] counsel, and then they would be able to successfully move to have [Plaintiff's] counsel disqualified.

In an email to us, Chao's attorney, Robert Frank, writes that "Whitney Engler agreed, as did her expert orthopedic witnesses, that the knee surgery performed by Dr. Chao was excellent and allowed her to return to high school competitive sports, where she qualified for and succeeded in California state track events. Her case was not about the orthopedic surgery performed by Dr Chao. Instead it was a product liability case about a postoperative cold therapy healing device."

Then there's Tom Fagan, who in 2007 came in for a knee replacement and lost a leg while Dr. Chao was out at a nightclub.

It's good for business to be a sports franchise's "head team physician." (According to court documents filed in the Engler case, Chao's net worth is about $3.4 million, with an annual income between $700,000 to $1.4 million in recent years.) That's why many health-care providers actually pay for the right, though Chao's medical group only offers the Chargers reduced rates. Whatever the quid pro quo, it's a baroque, conflicted arrangement that often pits a doctor's sworn duty to an athlete's health against his responsibility to the team that pays him.

Fagan, a then-53-year-old artist and a big football fan (and former college player), specifically chose Chao for his surgery because of his association with the team. He saw Chao's ad in every gameday program, placed for free. He saw Philip Rivers prominently displayed on Chao's website. When he first walked into the doctor's office, he was greeted by framed photos of Chargers players and other star athletes through the years. You can see some of them on the "Patients in Action" section of Chao's site.

Fagan writes in an email that he went to Chao thinking "he was the best, naively assuming that if the Chargers had employed him for so long he had to be. ... The Chargers' doctor must be the top surgeon at least in San Diego."

On Feb. 9, 2007, Fagan underwent a knee replacement at Scripps Memorial Hospital in La Jolla, with Chao overseeing the operation. That evening, according to nurses' notes, Fagan began experiencing pain and swelling in his leg consistent with Compartment Syndrome, a dangerous condition that affects circulation. Nurses attempted to locate Chao, but he had left the hospital. And, against hospital rules, he had failed to appoint another physician responsible for Fagan's care.

The Chargers' Doctor Is A Drunk Quack. Why Haven't They Fired Him?Expand

"I came very close to dying," Fagan remembers.

The nurses' notes record that by 1:45 a.m., Fagan's condition had worsened to the point where the doctor on call in the emergency room had to be summoned. After performing a test, she called Chao. Fagan had a blood clot, the ER doctor suspected, and needed an operation to restore circulation. Chao said he was unable to come in. By 4 a.m., when emergency surgery was performed (not by Chao), Fagan's leg was beyond saving. Three months later, it was amputated.

"I believe it was the next morning Chao showed up with his story about going to L.A. to see his mother," Fagan recalls. "When I did ask him what went wrong, he just said it was a very difficult surgery, whatever that meant."

Where was David Chao while his patient crossed the point of no return? Chao told the court the same thing he had told Fagan. According to his May 15, 2008, deposition in Fagan's lawsuit (found at bottom), he was in his car, driving north to Los Angeles to visit his sick mother.

Chao was placed under oath, and examined by Fagan's lawyer, Janice Mulligan:

Q. With whom did you drive?

A. By myself.

Q. Where did you go?

A. I was heading to my mom's house.


Q. Can you give us your best estimate as to approximately what time you left your house on the evening of February 9th with the intent of driving to Los Angeles?

A. It was late at night. It was something that I thought about doing earlier in the day, because my mom wasn't feeling that well. And in any case I had given some thought about going up earlier in the evening, decided not to because I hate driving in traffic, and it was later that night that I decided, well, if I were to go up now and not miss sleeping, and I'm kind of worried about her, there isn't going to be much traffic. And then I could go up and at least see her in the morning and zip right back down to my other commitments.

In Chao's sworn deposition, he answered dozens of questions about driving to his mother's, filling in some details when pressed, failing to recall others. He played up his role as a dutiful child: "I was primarily going up there as a son that feels guilty that I haven't seen her very often," he said, "and that she was alone and not feeling well."

A. Without being overly melodramatic, my mom is not the kind of person that if it really were bad to say that it's really bad. She's always going to say, as an immigrant, her personality and whatever, she's going to say no, I'm fine; I know you're busy. And I wasn't — I'm not suggesting that I was speeding up there to save her life in any way, shape or form, but I'm not sure where she was. My assumption was that she just wasn't feeling that well and there was nothing to take her to the emergency room for or anything else, but perhaps my peace of mind would be better having just seen her.

About a year later, Chao was ordered to produce proof of his whereabouts that night. His lawyer sheepishly turned in a receipt. The purchases were redacted, but it showed Chao was at the Belo nightclub in the Gaslamp Quarter ("San Diego's only true superclub!") at the exact time the hospital was desperately trying to reach him.

Janice Mulligan launched her own investigation into the receipt and discovered that Chao had run up a tab of over $300 at Belo, including an entire bottle of vodka. The waitress serving the doctor that night remembered him well, Mulligan noted in a memo, because Chao had "stiffed her on her tip."

Chao settled with Fagan out of court, which allowed the doctor to avoid any potential liability.

(One of Chao's insurers would go to court in an attempt to recover costs for defending Chao and paying out the malpractice settlement. Documents from that case, including a 2011 Los Angeles Superior Court Statement of Decision, provide a glimpse into the evidence produced against Chao and can be found at bottom.)

When the medical board initially declined to pursue a case against Chao over his handling of Tom Fagan, Mulligan wrote a letter to Patricia Stillwell, a board investigator. Mulligan was astounded that the state would let the matter go.

Not only did we provide your office with evidence of Dr. Chao's negligence, we also provided you with incontrovertible evidence of him committing perjury in his deposition and black and white evidence of his real whereabouts on the night in question- both in the form of a receipt and phone records.

Mulligan offered to provide two experts "who both were outraged by Dr. Chao's conduct," and who would "testify that his conduct fell far below the requisite standard of care." Mulligan closed with this:

Based on Dr. Chao's track record, it is only a matter of time before another patient is injured or killed because of Dr. Chao's recklessness. Will the Medical Board please reconsider its position on this case before it is too late?

When asked about the Fagan case, Robert Frank, Chao's attorney, writes in an email: "There was not any finding of malpractice by Dr. Chao." He added: "The California Medical Board reviewed Dr Chao's care of Mr Fagan and exonerated him. You know they would not have done so had there been any wrongdoing by Dr. Chao given the medical board's history with Dr. Chao."

We're told that Deputy AG Matthew Davis, representing the medical board, isn't necessarily done building his case. The attorney general's office declined comment, citing the ongoing action, but a person familiar with the process says Whitney Engler's and Tom Fagan's cases, among others, could be included in an amended medical board complaint. Because of that possibility, a hearing and decision in Chao's case may not happen until 2014, when his medical license is set to expire.

Accusations of substandard care extend all the way to Chao's medical equipment. Deadspin spoke with an executive at a medical repair company, one that maintained the MRI machines at Chao's office until 2011, when it stopped servicing the clinic after a dispute over unpaid bills. The company won a judgment against the clinic, says the executive, who requested anonymity because they still haven't been paid.

Chao's clinic owns two MRI machines, with which he scanned both NFL players and regular patients. One of Chao's machines, the executive says, "was in worse condition than any MRI I'd ever seen." The other lost its national accreditation after Chao refused to have it serviced.

The older, smaller machine was the Lunar Artoscan M extremity scanner, which the executive calls "arguably the lowest-quality MRI that's capable of doing a knee scan that's in use in America." It surely wasn't in widespread use: The Artoscan M, introduced in 1993, was phased out for its successor in 2004. GE, which had acquired Lunar Corp., junked its stockpile around 2006.

The last time Chao's machine was examined was in 2008, when the executive told him it would be cheaper to buy a new, more modern machine than to fix everything wrong with it. Chao declined to do either.

The executive believes Chao stopped using his Artoscan M soon after, but the images obtained with it are still around. This very much matters, the executive says, because the scans can be more difficult to read than those from higher-quality machines—the details aren't nearly as fine.

The tesla (T) is a unit of measurement of magnetic field strength. It's used to calibrate the imaging power of an MRI machine. Today, the industry standard is at least 1.5T, with 3T becoming widespread. The Artoscan-M has a magnet capable of just 0.2T.

"You don't know what you cannot see" on a diagnostic scan, the executive says, and even today, radiologists consulting the files of Chao's patients may be working with fuzzy images. According to one sports-medicine specialist who has worked for a pro sports team, it's entirely possibly to miss subtle tears in cartilage or ligaments when consulting lower-definition images. To this, Chao's attorney responds that "the radiologists who read the MRI studies from Dr. Chao never complained about the quality of the MRI machines and felt very comfortable putting their names on the reports interpreting the studies."

Chao's other full-body MRI machine was a Hitachi AIRIS II, introduced in 1999. It's relatively modern, the executive says, but still "at the lower end of the quality spectrum." It's a so-called open MRI, which is more comfortable for larger or claustrophobic patients. But the trade-off is that it will necessarily have a weaker field strength. (Our sports-medicine specialist says there's no reason athletes can't use a closed MRI: "No football player has ever gotten stuck in one.") In the case of the AIRIS II, the field strength is 0.3T, an order of magnitude weaker than today's top-of-the-line machines.

Chao began using the AIRIS II exclusively when he put the Artoscan M in mothballs, but for an extended period he failed to keep up its maintenance. An MRI physicist conducting a routine inspection noticed calibration issues in the AIRIS II, and in 2011 the repair company advised Chao to have it adjusted. Chao declined, the executive says.

As a result, Chao's AIRIS II lost its accreditation from the American College of Radiology. The ACR has accredited more than 35,000 facilities, and while the program is voluntary, beginning in 2012 it became mandatory for certain types of Medicare reimbursement. It's not known if Chao has since gotten the recommended repairs to his machine, but it still lacks accreditation from both of the major agencies.

The players likely know none of this, and it might not make a difference: They adore Chao. That he performs 90 percent of player surgeries, reads the report of the NFL-convened panel that cleared him, indicates "the high regard the players, medical staff and team have for him." Chargers players speak highly of Chao According to a person close to current and former Chargers players, they view him as a friend and a drinking buddy who happens to have a prescription pad.

One of those buddies was Junior Seau, who was very close to Chao while playing, and who continued to use him as his personal physician until his suicide last year. Chao still serves on the board of directors of the Junior Seau Foundation, a position he's held since at least 2002. Seau officiated at Chao's 2011 wedding. "David loved Junior with all his heart and soul," former Charger Mark Walczak told USA Today.

In 2007 two women sued Seau, claiming that after meeting him at the Gaslamp's popular Side Bar, Seau turned ugly, threw drinks on them, told one to "put your shirt on, your tits are too small," and the other to "get on a treadmill, you cunt." The women's lawyer said Seau was out drinking with David Chao that night. He'd sent Chao to the women's table to invite them over.

After Seau's death, Chao continued to hand out inspirational photos of the late player, including to athletes in the X Games, for which Chao serves as the chief medical officer. (Chao was on the scene in January, when Caleb Moore was struck by his snowmobile. Moore was diagnosed with a concussion and sent to the hospital. He died a week later, after heart and brain complications arose. It's not clear if Chao had any role in Moore's treatment.)

In August 2012, the San Diego County Medical Examiner's office released the findings from Seau's autopsy. (It can be found at bottom.) His toxicology report revealed the presence of Zolpidem, the prescription sedative commonly sold as Ambien. More Ambien was found in Seau's house. The "investigative narrative" notes that Seau was under the care of Chao.

Seau long battled insomnia. According to lawsuits filed by his parents and his four children, he had also been suffering from "severe depression." The FDA-approved labeling for Ambien urges caution when administering it to patients whose sleep troubles persist, and to patients "exhibiting signs of symptoms of depression" and warns that the medication could make those symptoms worse:

In primarily depressed patients, worsening of depression, including suicidal thinking, has been reported in association with the use of sedative/hypnotics.

"Confusion," "dementia," and "suicide attempts" are specifically listed as adverse effects that cropped up in clinical trials. The level of Zolpidem in Seau's body was consistent with ingestion fewer than 90 minutes prior to his death

"I understand that he and Dr. Chao were close friends," Chao's attorney tells us. He adds: "Of the few people Seau noted in his Chargers Hall of Fame speech he mentioned Dr. Chao. He publicly and with great passion thanked Dr Chao many times for keeping him healthy. The issue you raise seems ridiculous."...

Read more, including lots of official documents, HERE.

Thursday, June 13, 2013

Myriad Genetics shares surge after mixed ruling from Supreme Court on gene patentability

Myriad Genetics shares surge after mixed ruling from Supreme Court on gene patentability
By Associated Press
June 13, 2013

TRENTON, N.J. — Shares of diagnostic test maker Myriad Genetics Inc. surged Thursday after the Supreme Court handed the company a partial victory in a battle over validity of Myriad patents underlying its lucrative test for genes linked to high risk of breast and ovarian cancer.

The ruling likely will eventually benefit rivals, as well as doctors and patents wanting to determine the best course of treatment.

Myriad, based in Salt Lake City, sells a popular test for the BRCA 1 and BRCA 2 genes linked to hereditary risk of breast and ovarian cancer — the only test currently available because of its patents. They were challenged by a scientists group, leading to the Supreme Court’s review, even though the U.S. Patent and Trademark Office has been awarding patents on human genes for almost 30 years.

The high court ruled that genes naturally found in the body cannot be patented, but that synthetically created genetic material, called complementary or cDNA, can be patented. Patents enable inventors to prevent others from making, using or selling a novel device or process they’ve created.

While Myriad said the ruling will preserve its revenue from the test, other experts said it will open the door for competing tests and for scientists to do gene-related disease research without restraints.

“We are very pleased with the outcome,” which ends four years of litigation, Myriad’s general counsel, Rick Marsh, told The Associated Press in an interview.

He said the ruling invalidates only five Myriad patent claims, which involve isolated bits of naturally occurring DNA. That’s out of more than 500 separate claims in 24 patents the company holds for the company’s BRACAnalysis test, launched in 1996 and used by more than a million women so far.

“The balance of our patent estate is still valid and enforceable,” Marsh said.

He said the court’s ruling upholds Myriad’s “method” patent claims, those detailing specific processes for testing patients’ genes for their cancer susceptibility, as well as ones covering cDNA. That is the synthetic DNA — created to look like the natural DNA at issue — that Myriad uses in its testing of patient samples.

Marsh said the ruling is not expected to decrease revenues for sales of the BRACAnalysis test, the top seller for the Salt Lake City-based company.

“I think that’s why you’re seeing a market reaction,” he added, referring to a big jump in the price of Myriad stock following the ruling.

In early afternoon trading Thursday, Myriad shares were up 5.4 percent, or $2.36, at $35.73. They had earlier set a 52-week high at $38.27, with trading volume more than nine times the daily average of 1.1 million shares.

However, Jeffrey Rosenfeld, a researcher and assistant professor at the University of Medicine and Dentistry of New Jersey, said the ruling is good news for researchers, who now will be able to sequence genes to try to better understand diseases and to create new treatments — without fear of being sued by companies such as Myriad...

Supreme Court says human genes cannot be patented
The Washington Post
June 13, 2013

The Supreme Court says companies cannot patent human genes, a decision that could profoundly affect the medical and biotechnology industries.

In a unanimous decision, the court struck down patents held by Myriad Genetics Inc. on two genes linked to increased risk of breast and ovarian cancer.