Category: Daily News

Quest Diagnostics Inc. has agreed to pay $6 million to resolve a lawsuit by the United States alleging that Berkeley HeartLab Inc., of Alameda, California, violated the False Claims Act by paying kickbacks to physicians and patients to induce the use of Berkeley for blood testing services and by charging for medically unnecessary tests. Quest, which is headquartered in Madison, New Jersey, acquired Berkeley in 2011, and ended the conduct that gave rise to the settlement.

Physicians refer their patients to independent laboratories like Berkeley to conduct tests on blood samples. According to the government’s complaint, Berkeley paid kickbacks to referring physicians disguised as “process and handling” fees. The complaint also alleged that Berkeley paid kickbacks to patients by routinely waiving copayments owed by certain patients who were legally required to pay for part of their tests. Allegedly, Berkeley paid the kickbacks to induce both the physicians and patients who received them to choose Berkeley over other laboratories. The government’s complaint further alleged that these illegal practices resulted in medically unnecessary cardiovascular tests being charged to federal healthcare programs.

The Anti-Kickback Statute prohibits offering, paying, soliciting or receiving remuneration to induce referrals of items or services covered by federally funded programs. The Anti-Kickback Statute is intended to ensure that a physician’s medical judgment is not compromised by improper financial incentives and is instead based on the best interests of the patient. The Anti-Kickback Statute also prohibits routinely waiving patient copayments to ensure that patients are appropriately incentivized to refuse unnecessary tests.

The lawsuit was initially filed by Dr. Michael Mayes under the qui tam, or whistleblower, provisions of the False Claims Act. Under the act, private citizens can bring suit on behalf of the government for false claims and share in any recovery. The act permits the United States to intervene in and take over a whistleblower suit. The United States partially intervened in this and two related actions on March 31, 2015, and is continuing to pursue claims against the remaining defendants: Latonya Mallory, the former CEO of Health Diagnostics Laboratory Inc., and marketing company BlueWave Healthcare Consultants Inc. and its owners, Floyd Calhoun Dent III and Robert Bradford Johnson. Dr. Mayes’ share of the settlement with Quest has not been determined.

On April 9, 2015, the United States announced settlements with two other laboratories – Health Diagnostics Laboratory Inc. of Richmond, Virginia, and Singulex Inc., of Alameda, California – for engaging in conduct similar to that resolved in the settlement with Quest.

This matter was investigated by the Civil Division’s Commercial Litigation Branch, the U.S. Attorney’s Offices for the District of South Carolina and the District of Columbia, FBI’s Columbia Field Office and the FBI Healthcare Fraud Unit Major Provider Response Team (MPRT), HHS-OIG, the U.S. Office of Personnel Management’s Office of Inspector General, and the Department of Defense’s Office of Inspector General Defense Criminal Investigative Service.

The cases is captioned United States ex rel. Mayes v. Berkeley HeartLab Inc., et al., Case No. 9:11-CV-01593-RMG (D.S.C.). The claims settled by these agreements and asserted against these companies and individuals are allegations only, and there has been no determination of liability.

The Division of Workers’ Compensation (DWC) has posted the second interim status report on its efforts to promulgate regulations for an evidence-based workers’ compensation drug formulary as required by Assembly Bill 1124. The goal is to adopt the drug formulary by July 1, 2017.

The DWC contracted with the RAND Corporation to conduct research and provide consultation on the design, implementation, and economic impact of the formulary and related policies. RAND issued an August 2016 report which analyzed the various formularies used by other states and organizations, and explained the benefits and disadvantages of each approach and the potential applicability to California workers’ compensation. The RAND report indicated that the formulary should be consistent with the MTUS guidelines. The report noted that the methods used to develop the American College of Occupational and Environmental Medicine (ACOEM) guidelines are rigorous, transparent, and evidence-based. The DWC decided to proceed with using the ACOEM guidelines for the formulary to maintain consistency with the DWC’s MTUS, which is primarily based on ACOEM guidelines.

Public meetings were held in 2015 and 2016 giving stakeholders an opportunity to provide input on the development of the formulary and the implementation of AB 1124.

The DWC posted draft formulary regulations on the DWC Forum webpage on August 26, 2016, together with the RAND formulary report and proposed ACOEM Guidelines for public review and discussion. These postings permitted all interested stakeholders to provide further input on the formulary development.

The formal rulemaking process began on March 17, 2017, with the publication of the Notice of Proposed Rulemaking in the California Regulatory Notice Register. In addition, the DWC posted the rulemaking documents on the DWC website

In addition to the public hearings and rulemaking, the DWC has provided updates on formulary development and received public comments at Commission on Health and Safety and Workers’ Compensation’s (CHSWC) meetings. The latest update was provided at the CHSWC meeting on March 24, 2017.

DWC will again accept oral testimony and written comments on the proposed formulary regulations at a public hearing on Monday, May 1 from 10 a.m. to 5 p.m. This hearing will be held at the Elihu Harris State Office Building Auditorium in Oakland. More details are available on the DWC website.

DWC will review all comments received to determine if changes to the regulatory proposal are warranted. If so, DWC will issue a revised proposal for a 15-day public comment period. Upon completion of the rulemaking action, the regulations will be submitted to the Office of Administrative Law for approval and filing with the Secretary of State.

Christopher Rice worked for the City of Jackson as a police officer. He started employment with City as a reserve officer in August 2004, and became full time in 2005. He sustained injury to his neck during the cumulative period ending April 22, 2009, at which time Rice was 29 years old.

Before undergoing neck surgery, Rice was examined by QME Dr. Sloane Blair in November 2011. Dr. Blair examined Rice and reviewed his medical records. Rice’s injury was cumulative, i.e., he had not suffered an exact or isolated injury. Rice and his treating physician believed his pain was a consequence of repetitive bending and twisting of his head and neck.

An X-ray showed degenerative disc disease. Dr. Blair diagnosed Rice with cervical radiculopathy and cervical degenerative disc disease.

As is relevant to the issue of apportionment, Dr. Blair found Rice’s condition was caused by: (1) his work activities for the City; (2) his prior work activities; (3) his personal activities, including prior injuries and recreational activities; and (4) his personal history, in which category Blair included “heritability and genetics,” Rice’s “history of smoking,” and “his diagnosis of lateral epicondylitis [(commonly known as tennis elbow)].” Dr. Blair apportioned each factor equally at 25 percent.

Dr. Blair re-evaluated Rice following his neck surgery. Her diagnosis was unchanged and the four causes contributing to the diagnosis were unchanged, but the apportionment was changed. Dr. Blair stated, “Since his evaluation on 11.7.11, there are specific publications that have lent even more support to the causation of genomics/genetics/heritable issues in terms of his injury.” Dr. Blair listed three such studies, and stated that because more recent studies supported “genomics as a significant causative factor in cervical spine disability,” her apportionment changed to 17 percent, each to Rice’s employment with City, previous employment, and personal activities, and 49 percent to his personal history, “including genetic issues.”

The ALJ found the City had carried its burden of showing apportionment as to 49 percent attributable to genetic factors, and Rice filed for reconsideration, The Board granted reconsideration and eventually ordered the matter returned to the trial level for an unapportioned award of permanent disability. The Board reasoned that “finding causation on applicant’s ‘genetics’ opens the door to apportionment of disability to impermissible immutable factors. . . . ” The Court of Appeal reversed the WCAB in the published case of City of Jackson v WCAB.

Since the enactment of Senate Bill No. 899 apportionment of permanent disability is based on causation, and the employer is liable only for the percentage of permanent disability directly caused by the industrial injury.

Apportionment may now be based on “‘other factors'” that caused the disability, including “the natural progression of a non-industrial condition or disease, a preexisting disability, or a post-injury disabling event[,] . . . pathology, asymptomatic prior conditions, and retroactive prophylactic work preclusions . . . .”

Precluding apportionment based on “impermissible immutable factors” would preclude apportionment based on the very factors that the legislation now permits, i.e., apportionment based on pathology and asymptomatic prior conditions for which the worker has an inherited predisposition.

The Order Granting Reconsideration was annulled, and the case remained to the Board to deny reconsideration and reinstate apportionment.

Joseph Thomas thought he had it made when he landed a $170,000 job as a software engineer at Uber’s San Francisco headquarters last year. But his time at Uber turned into a personal tragedy, one that will compel the ride-hailing company to answer questions before a Workers Compensation Judge about its aggressive work culture, and may be a test of limits on psychiatric claims in California.

Always adept with computers, the news story in the San Francisco Chronicle says that Joseph Thomas worked his way up the ladder at tech jobs in his native Atlanta, then at LinkedIn in Mountain View, where he was a senior site reliability engineer. He turned down an offer from Apple to go to Uber, because he felt he could grow more with the younger company and was excited about the chance to profit from stock options when it went public.

But at Uber, Thomas struggled in a way he’d never experienced in over a decade in technology. He worked long hours. He told his father and his wife that he felt immense pressure and stress at work, and was scared he’d lose his job. They urged him to see a psychiatrist. He told the doctor he was having panic attacks, trouble concentrating and near-constant anxiety. All suggested that he leave his job, but he was adamant that he could not.

“It’s hard to explain, but he wasn’t himself at all,” said his wife Zecole Thomas. “He’d say things like, ‘My boss doesn’t like me.’ His personality changed totally; he was horribly concerned about his work, to the point it was almost unbelievable. He was saying he couldn’t do anything right.”

One day in late August, Zecole came home from dropping their boys off at school. Joseph was sitting in his car in the garage. She got into the passenger seat to talk to him. Joseph had shot himself. He died in the hospital two days later, a week before he would have turned 34.

His father and widow are convinced that the work environment and stress at Uber triggered his suicide. Zecole Thomas has filed a workers’ compensation claim seeking to hold Uber accountable for her husband’s mental decline. Medical records from two East Bay psychiatrists he visited in the weeks before his suicide show that he reported job-related “high anxiety,” panic attacks, difficulty concentrating and insomnia.

Uber denied the benefits claim through its insurance carrier. In California, Labor Code 3208.3 (d)  provides that workers’ compensation does not cover psychiatric injuries until after six months of employment. Joseph Thomas had worked slightly less than five months at Uber when he killed himself.

But there is an exception to the six-month rule. It does not apply “if the psychiatric injury is caused by a sudden and extraordinary employment condition.”

San Francisco attorney Richard Richardson, who represents Zecole Thomas and her sons, said Thomas’ situation may be one of those exceptions. This case will no doubt be closely watched since it has high media attention in Silicon Valley circles.

Uber’s work culture has come under scrutiny after explosive revelations about the world’s most valuable startup. In February, software engineer Susan Fowler wrote a blog post about sexual harassment and sexism at Uber and said its human resources department ignored complaints.

At least three former employees have filed lawsuits alleging sexual harassment or verbal abuse from Uber managers, according to the New York Times, which said other current and former employees were also considering legal action.

Even early investors Freada Kapor Klein and Mitch Kapor posted an open letter to Uber blasting it for “a culture plagued by disrespect, exclusionary cliques, lack of diversity, and tolerance for bullying and harassment of every form.”

Uber said it took the allegations seriously and hired former U.S. Attorney General Eric Holder to investigate its workplace for issues of sexism, diversity and inclusion. That report is pending.

A cartilage-mimicking material created by researchers at Duke University may one day allow surgeons to 3-D print replacement knee parts that are custom-shaped to each patient’s anatomy.

Human knees come with a pair of built-in shock absorbers called the menisci. These ear-shaped hunks of cartilage, nestled between the thigh and shin bones, cushion every step we take. But a lifetime of wear-and-tear – or a single wrong step during a game of soccer or tennis – can permanently damage these key supports, leading to pain and an increased risk of developing arthritis.

According to the report in Medical News Today, the hydrogel-based material the researchers developed is the first to match human cartilage in strength and elasticity while also remaining 3-D-printable and stable inside the body. To demonstrate how it might work, the researchers used a $300 3-D printer to create custom menisci for a plastic model of a knee.

“We’ve made it very easy now for anyone to print something that is pretty close in its mechanical properties to cartilage, in a relatively simple and inexpensive process,” said Benjamin Wiley, an associate professor of chemistry at Duke and author on the paper, which appears online in ACS Biomaterials Science and Engineering.

After we reach adulthood, the meniscus has limited ability to heal on its own. Surgeons can attempt to repair a torn or damaged meniscus, but often it must be partially or completely removed. Available implants either do not match the strength and elasticity of the original cartilage, or are not biocompatible, meaning they do not support the growth of cells to encourage healing around the site.

Recently, materials called hydrogels have been gaining traction as a replacement for lost cartilage. Hydrogels are biocompatible and share a very similar molecular structure to cartilage: if you zoom in on either, you’ll find a web of long string-like molecules with water molecules wedged into the gaps.

But researchers have struggled to create recipes for synthetic hydrogels that are equal in strength to human cartilage or that are 3-D-printable.

“The current gels that are available are really not as strong as human tissues, and generally, when they come out of a printer nozzle they don’t stay put – they will run all over the place, because they are mostly water,” Wiley said.

Feichen Yang, a graduate student in Wiley’s lab and author on the paper, experimented with mixing together two different types of hydrogels – one stiffer and stronger, and the other softer and stretchier – to create what is called a double-network hydrogel. “The two networks are woven into each other,” Yang said. “And that makes the whole material extremely strong.”

3-D printing of other custom-shaped implants, including hip replacements, cranial plates, and even spinal vertebrae, is already practiced in orthopedic surgery. These custom implants are based on virtual 3-D models of a patient’s anatomy, which can be obtained from computer tomography (CT) or magnetic resonance imaging (MRI) scans.

Meniscus implants could also benefit from 3-D printing’s ability to create customized and complex shapes, the researchers say. “Shape is a huge deal for the meniscus,” Wiley said. “This thing is under a lot of pressure, and if it doesn’t fit you perfectly it could potentially slide out, or be debilitating or painful.”

“A meniscus is not a homogenous material,” Yang added. “The middle is stiffer, And the outside is a bit softer. Multi-material 3-D printers let you print different materials in different layers, but with a traditional mold you can only use one material.”

In a simple demonstration, Yang took a CT scan of a plastic model of a knee and used the information from the scan to 3-D print new menisci using his double network hydrogel. The whole process, from scan to finished meniscus, took only about a day, he says.

“This is really a young field, just starting out,” Wiley said. “I hope that demonstrating the ease with which this can be done will help get a lot of other people interested in making more realistic printable hydrogels with mechanical properties that are even closer to human tissue.”