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Walgreens Resolves Whistleblower Claim for $10 Mil

United States Attorney Phillip A. Talbert announced that Walgreen Co. has paid $9.86 million to resolve allegations that it violated the federal False Claims Act when it knowingly submitted claims for reimbursement to California’s Medi-Cal program that were not supported by applicable diagnosis and documentation requirements.

Walgreens is one of the largest drugstore chains in the United States, operating approximately 630 stores in California. The company is headquartered in Deerfield, Illinois. The Medi-Cal program is administered by the California Department of Health Care Services (DHCS) and relies on both federal and state funding to provide health care to millions of Californians, including those with low incomes and disabilities.

Medi-Cal utilizes a formulary list, commonly known as “Code 1” drugs, which designates certain restrictions for each listed drug, including restrictions pertaining to diagnoses. Medi-Cal will reimburse certain Code 1 drugs only for approved diagnoses, taking into account criteria such as the drug’s safety, efficacy, misuse potential, and cost.

Pharmacies serve the critical gatekeeping function of confirming and certifying that these Code 1 drugs are dispensed for the approved diagnoses. Walgreens may bill for drugs prescribed outside of the approved diagnoses, but it must submit a request to DHCS that includes a justification for the non-approved use. This settlement resolves allegations that Walgreens failed to confirm and document the requisite diagnoses, and in some instances dispensed drugs for non-approved diagnoses, then knowingly billed Medi-Cal for these prescriptions.

The allegations resolved by this settlement were first raised in two lawsuits filed against Walgreens under the qui tam, or whistleblower, provisions of the False Claims Act by a former Walgreens pharmacist and a former pharmacy technician. The Act allows private citizens with knowledge of fraud to bring civil actions on behalf of the government and to share in any recovery. The whistleblowers in this matter will collectively receive approximately $2.3 million of the recovery proceeds.

This settlement is the result of a joint effort by the United States Attorney’s Office for the Eastern District of California and California’s Bureau of Medicaid Fraud and Elder Abuse. Assistant United States Attorney Catherine J. Swann handled the matter for the United States with assistance from the Department of Health and Human Services, Office of Inspector General, and the Federal Bureau of Investigation. The claims settled by this agreement are allegations only, and there has been no determination of liability.

DWC Reports Final Steps for Drug Formulary

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.

Appellate Ruling Blocks Anthem – Cigna Merger

The United States Court of Appeals on Friday blocked health insurer Anthem Inc’s bid to merge with Cigna, upholding a lower court’s decision that the $54 billion deal should not be allowed because it would lead to higher prices for healthcare.

The ruling will probably kill the proposed merger, which was opposed by the U.S. Justice Department, 11 states and a District Court judge after consumers, medical professionals and others objected to it. In the end, Cigna itself tried to back out.

Still, Anthem and Cigna have the option of trying to save the deal by asking the appeals court to re-consider the case or appealing straight to the U.S. Supreme Court.

Anthem’s purchase of Cigna would have create the largest U.S. health insurer. Rivals Aetna Inc. and Humana Inc. had also sought to merge but that deal collapsed this year amid opposition from the federal government and states.

Anthem, said in a statement late Friday that it was disappointed by the appeals court’s decision. “We are committed to completing the transaction and are currently reviewing the opinion and will carefully evaluate our options,” the company said in a statement.

In a split decision, the U.S. Court of Appeals for the D.C. Circuit disagreed with Anthem’s contention that the Justice Department and lower court improperly rejected its assertions that the deal would lead to billions of dollars in medical savings.

“Anthem has not explained why these projected savings would even exist,” Judge Judith Rogers wrote in the opinion. “The record is clear that Anthem, unlike Cigna, has already achieved whatever economies of scale are available.”

In a dissent, Judge Brett Kavanaugh argued that the merger would benefit the biggest customers, mainly large companies with employees in many states. Kavanaugh argued that a combined Anthem/Cigna would require higher payments to manage the accounts but that would be offset by better negotiated rates paid to providers.

Kavanaugh, however, noted that the deal could be stopped based on monopsony arguments that the new company would have too much heft in negotiating with doctors and hospitals.  A monopsony is a market situation in which there is only one buyer.

The California Insurance Commissioner applauded the ruling saying that the “federal appellate court decision affirming the district court’s permanent injunction blocking the merger of two of the nation’s largest health insurers is a significant win for consumers who need more choice, not less, in an already highly concentrated health insurance market. Bigger was definitely not better for consumers when it came to the Anthem-Cigna merger.”

In another obstacle, Anthem and Cigna have been at loggerheads for months and are suing each other. Cigna has sought to abandon the merger and force Anthem to pay a $1.85 billion breakup fee while Anthem filed a lawsuit to force its smaller rival to go through with the combination.

3rd DCA Reinstates Apportionment Based on Genetics

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.

Drugmakers take Biosimilar Case to Supreme Ct.

The Supreme Court on Wednesday considered a dispute between rival drug companies that could affect how quickly life-saving generic medicines are available to the public.

The case before the justices involves the cutting-edge field of biologics – drugs made from living cells instead of chemicals. The drugs have led to major advances in treating cancer and other diseases, but often come with a massive price tag.

A 2010 law allows cheaper generic versions known as biosimilars to be produced after a 12-year exclusive run for the original.

At issue is whether companies that make biosimilars must tack on an additional six months after gaining federal approval before they can sell the drugs. The extra time can mean billions of dollars in additional sales of original drugs before biosimilars enter the market.

Several of the justices seemed to side with California-based Amgen, which claims that rival Sandoz did not wait long enough before giving notice of its near-copy of Amgen’s cancer drug Neupogen.

“We are being asked to interpret very technical provisions that I find somewhat ambiguous and I’m operating in a field I know nothing about,” Justice Stephen Breyer said at one point during the 70-minute argument. “But it’s going to have huge implications for the future.”

The dispute involves the drug Zarxio, an alternative that Sandoz developed to compete with Neupogen that sells for about 15 percent less than the original product. The drug helps boost red blood cells in cancer patients.

Amgen sued Sandoz for patent infringement, claiming among other things that Sandoz violated the 2010 Biologics Price Competition and Innovation Act. That law requires biosimilar makers to give a six-month notice of sales to rivals.

A federal appeals court ruled in 2015 that the notice can’t take place until after biosimilar makers gain approval from the Food and Drug Administration.

Sandoz, a unit of Swiss drug giant Novartis, says that reading of the law is wrong, and unfairly gives an additional six months of exclusive sales to the original drugmaker.

“That ruling will wrongly delay the marketing of every biosimilar,” Sandoz’s lawyer Deanne Maynard told the justices. She said Congress “would not have extended the 12-year exclusivity period in such a bizarre way.”

But Justice Anthony Kennedy said it seems like the time has to start running from the date the biosimilar is licensed. And Chief Justice John Roberts said the original drugmaker would have trouble bringing a patent infringement case without knowing the specifics of the biosimilar.

“We don’t even know what this thing is,” he said.

The justices had fewer questions for Amgen’s attorney, Seth Waxman. He argued that until the FDA determines the type of compound it’s approving and what it can be used for “you can’t give notice of anything.”

A ruling is expected by the end of June.

Uber Engineer Suicide to Test Psyche Claim Law

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.

California Heads to Single Payer Health Care – Again

A proposal considered by California lawmakers would substantially remake the health care system by eliminating insurance companies and guaranteeing coverage for everyone.

After more than two hours of debate, the Senate Health Committee cleared the State’s latest attempt at adopting universal health care despite key concerns as to how the system will be paid for.

Senate Bill 562 passed the Senate Health Committee 5-1. It now advances to the Senate Appropriations Committee to face tough questions about how Californians would fund a single-payer health care system.

The legislation would create a single-payer health care system, provide health insurance to all California residents regardless of immigration status and allow state regulators to negotiate drug costs with the pharmaceutical industry. Under SB 562, every one of the 39 million residents would be eligible to receive all covered benefits without deductibles or co-payments. Users would be able to choose from any provider signed up for the government-run system.

The program would be managed by a 9-member board appointed by the Legislature and governor, as well as a 22-member public advisory committee. The board would be tasked with securing providers, negotiating reimbursement prices and establishing standards for “safe, therapeutic care for all residents of the state.”

Currently, 56 percent of Californians obtain health care through their employer, while 39 percent are enrolled in some form of Medi-Cal or Medicare. The cost of California’s health care is staggering: in 2016, health care expenditures totaled more than $367 billion.

Critics say the plan is a “job-killer” and have questioned the timing of transforming the state’s health care system with Congress also plotting large-scale health care reforms.

“It’s an inherently flawed system lacking competition and important cost-containment mechanisms which will result in lower quality and higher cost health care for all Californians,” testified Karen Sarkissian of the California Chamber of Commerce. “It should be called Medi-Cal for all.”

The health insurance sector has predictably lined up against the bill, including Anthem Blue Cross, Kaiser Permanente and Blue Shield of California.

Gov. Brown also expressed skepticism last month about how the single-payer system would be funded and implemented.

Supporters will need to figure out how to comply with California’s Proposition 98 if they want to raise taxes to pay for universal health care. Proposition 98 requires 40 percent of revenues from new taxes to go to education. They will also have to attain a federal waiver in order to receive federal health care support. Lara said if the waiver is denied, he has identified other ways around the denial – including a potential lawsuit.

No state currently has a single-payer system, but California lawmakers have been kicking around the idea for decades. Voters rejected a universal health care initiative in 1994 and five separate bills have been proposed since 2003, including a 2007 effort vetoed by Arnold Schwarzenegger.

Press “Print” for New Knee Meniscus

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.”

Everest Elected to WCIRB Governing Committee

Everest National Insurance Company has been elected to the Governing Committee of the Workers’ Compensation Insurance Rating Bureau (WCIRB) of California.

The WCIRB Governing Committee is responsible for setting policy and overseeing the management of the affairs of the WCIRB. This election by Everest’s peer members of the WCIRB is for a three year term.

Commenting on the recent election to the WCIRB Governing Committee Mike Mulray, Chief Underwriting Officer of the Everest Insurance North America insurance companies said “Everest has been committed to workers and employers of the state of California as a leading underwriter of workers compensation insurance in the state for nearly two decades. We appreciate the opportunity to give back by sharing our voice on important topics and issues relevant to the California market. We look forward to working closely with Bill Mudge and his team at the WCIRB as well as with the rest of the committee members.”

The WCIRB membership is comprised of all companies licensed to transact workers’ compensation insurance in California, over 400 member companies in total.

The Governing Committee is represented by twelve members: seven private insurers; State Compensation Insurance Fund; and four public members – two representing insured employers and two representing organized labor.

Except for the State Compensation Insurance Fund, insurer members are elected for three-year terms by the membership at the Annual Meeting, while public members are appointed for two-year terms by the Insurance Commissioner.

Everest Re Group, Ltd. is a Bermuda holding company that operates through a number of subsidiaries. Everest National Insurance Company and Everest Security Insurance Company provide property and casualty insurance to policyholders in the U.S. Everest Indemnity Insurance Company offers excess and surplus lines insurance in the U.S.

Prime Healthcare Fraud Trial Set for Feb 2018

Ontario California based Prime Healthcare Services and its nonprofit arm, Prime Healthcare Foundation, have faced multiple lawsuits along with angry employee unions in communities where it works or is taking over hospitals.

Federal prosecutors have intervened in a whistleblower lawsuit against Prime Healthcare Services Inc. and the system’s CEO that alleges emergency department physicians were pressured to admit patients who did not need inpatient care, according to the Justice Department.

The lawsuit targets 14 hospitals owned by Prime in California. The whistleblower lawsuit was brought by Karen Berntsen, the former director of quality and risk management at Alvarado Hospital in San Diego, who estimated that improper short-stay admissions accounted for more than $50 million in false claims.

Most of these hospitals are in Southern California, including Centinela Hospital Medical Center in Inglewood, Encino Hospital Medical Center, Sherman Oaks Hospital and Huntington Beach Hospital.

The suit accuses Prime of engaging in a “systematic practice” of pushing physicians to increase the number of inpatient admissions for Medicare beneficiaries who go to the emergency departments at Prime hospitals, regardless of whether it is medically necessary.

The FBI began investigating Prime Healthcare in 2011, shortly after the whistleblower lawsuit against the organization was filed.

In January 2017, the federal court denied Prime’s motion to dismiss, holding that the government had alleged sufficient facts to support its false claims case against Prime. The trial is now set for February 2018.

Prime owns and operate 43 acute-care hospitals across the country. Since its founding in 2001, Prime has steadily scooped up troubled hospitals, turning them around by negotiating better rates from insurers, adding profitable service lines and implementing aggressive billing tactics, among other strategies.

But in 2015 Prime pulled out of a deal to buy six financially struggling hospitals in California, with those hospitals facing bankruptcy.

Prime told the LA Times that California’s attorney general put “impossible” conditions on the sale, which caused them to back out. The target hospitals were St. Vincent Medical Center and St. Francis Medical Center in L.A. County and four in Northern California: O’Connor Hospital in San Jose, Saint Louise Regional Hospital in Gilroy, Seton Medical Center in Daly City and Seton Coastside in Moss Beach, near Half Moon Bay..

Prime has also been tangled in labor disputes for years with the Service Employees International Union-United Healthcare Workers West, which has publicized a variety of allegations against the company.