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Tag: 2019 News

SCOTUS Rejects Maryland’s Drug Pricing Law Case

The U.S. Supreme Court rejected Maryland’s bid to revive a law aimed at preventing price gouging by pharmaceutical companies, dealing a setback to the power of states to rein in prescription drug costs.

Last year, Maryland became the first state in the country to give its attorney general the power to take legal action against drug companies that dramatically increase the price of off-patent or generic drugs.

The complicated law applied to generic or off-patent drug makers that manufacture a medicine at least three other firms also make. If those conditions applied, companies could not impose a significant price increase without justifying it to the attorney general, who could ask a judge to order that the price increase not take effect. Violating the law carried a $10,000 fine.

The Association for Accessible Medicines, a trade group representing generic drug manufacturers such as Teva Pharmaceutical Industries Ltd and Mylan NV, sued its Attorney General Brian E. Frosh and Dennis R. Schrader, who was the state’s acting health secretary, to block the measure.

The case worked it way to the U.S. Court of Appeals for the Fourth Circuit, which said in a 2-to-1 ruling that the 2017 law is unconstitutional because it violates the commerce clause of the U.S. Constitution.

“Although we sympathize with the consumers affected by the prescription drug manufacturers’ conduct and with Maryland’s efforts to curtail prescription drug price gouging, we are constrained to apply the dormant commerce clause to the Act,” Judge Stephanie D. Thacker wrote for the majority opinion. “We hold that the Act is unconstitutional under the dormant commerce clause because it directly regulates transactions that take place outside Maryland.”

Maryland argued that the 4th Circuit’s decision not only prevents Maryland and other states from reining in abusive prescription-drug prices that harm consumers and public health but that the ruling could call into question other state regulatory efforts. At issue was whether the measure violated Supreme Court precedents that constrain states from enacting laws that burden out-of-state competitors.

The U.S. Supreme Court just declined to take up Maryland’s appeal of the 2018 federal appeals court ruling, without comment, letting a lower court ruling against the law stand.

So far, California as had better results with S.B. 17. The California law requires all drug price hikes over 16% over a two-year span to be subject to transparency requirements, which would discourage double-digit price increases and better negotiations between drug companies and purchasers.

Last August, the U.S. District Court, Eastern District of California dismissed a lawsuit brought by the Pharmaceutical Research and Manufacturers of America (PhRMA) to halt S.B. 17.

PhRMA filed this lawsuit alleging the law as unconstitutional and seeking a permanent injunction preventing its implementation. The U.S. District Court dismissed the suit as PhRMA did not produce enough facts to substantiate their claims or standing.

Physical Therapy Clinics Resolve Fraud Claims for $450K

Two San Diego physical therapy clinics and their owners have paid $450,000 to resolve allegations that they fraudulently billed TRICARE for medical services that were supposedly performed by qualified medical doctors, but were actually provided by unqualified and unauthorized employees.

South Bay Physical Medicine, Inc. and Direct Health Medical Center, Inc. d/b/a San Diego Spine and Rehabilitation were physical therapy clinics.  Brett Allan, Sr., Brett Allan, Jr. and Jeff Allan owned the clinics.

“The United States Attorney’s Office works hard to safeguard the integrity of the TRICARE program and the safety of our soldiers and their family members,” said U.S. Attorney Robert Brewer.  “Health care fraud hurts the entire health care system, from taxpayers down to honest providers and innocent patients. We are committed to using all available remedies, both civil and criminal, to combat health care fraud.”

The Government’s resolution of this matter illustrates its emphasis on combating health care fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, and abuse can be reported at https://www.tricare.mil/ContactUs/ReportFraudAbuse.

This matter was handled by Assistant U.S. Attorney Dylan M. Aste of the U.S. Attorney’s Office for the Southern District of California, the Federal Bureau of Investigation, the Defense Criminal Investigative Service, and the Defense Health Agency Program Integrity Office.

Worker Must Prove Injury in Uninsured Employer Tort Claim

Evangelina Ruiz began work as a legal assistant with Carter and Carter, APLC in 2007 at their office in Corona. Christopher Carter specialized in mold and mold remediation cases.

In September 2011, Christopher Carter accepted a tort case involving black water and mold in a house. Ruiz was assigned to inspect documents in the case, which she alleged contained mold and mold spores.

Ruiz became ill. Ruiz filed a worker’s compensation claim but Carter advised Ruiz it did not carry worker’s compensation insurance during the time that she alleged to have been sickened by the documents.

Ruiz filed a lawsuit in the trial court and with the Worker’s Compensation Appeals Board (WCAB).

The second amended complaint filed in the trial court, which alleged one cause of action for premises liability. Carter brought a motion for summary judgment, which was granted by the trial court.

Ruiz appealed the grant of Carter’s Motion claiming that (1) because Carter was an illegal uninsured employer, she only had to prove worker’s compensation causation, which is a lower standard than the civil causation standard used by the trial court in granting the Motion; (2) pursuant to Labor Code section 3708, Carter had the burden to prove it was not negligent; and (3) the trial court erred by rejecting Ruiz’s argument when she filed the first amended complaint, that she could allege different theories of negligence

The court of appeal conclude the Motion was properly granted and affirm the judgment in the unpublished case of Ruiz v. Carter & Carter, APL.

LC 3706 states, “If any employer fails to secure the payment of compensation, any injured employee or his dependents may bring an action at law against such employer for damages, as if this division did not apply.” LC 3708 mandates a presumption not present in other tort actions that the injury to the employee “was a direct result and grew out of the negligence of the employer, and the burden of proof is upon the employer, to rebut the presumption of negligence.”

Here, Ruiz had the burden of proving by a preponderance of the evidence that she was injured in the Carter offices. Ruiz failed to provide any competent evidence with the SAC to support she was injured at Carter’s office.

The burden of proof did not shift to Carter under Labor Code section 3708 to prove that it was not negligent because Ruiz failed to present competent evidence that she had suffered an injury at work.

UK Funding AI to Detect Insurance Fraud

A project to develop breakthrough artificial intelligence technology for the anti-fraud sector is one of a number of new projects set to receive funding to enable the UK accountancy, insurance and legal services industries to transform how they operate.

The artificial intelligence software, being developed by Intelligent Voice Ltd, Strenuus Ltd. and the University of East London will combine AI and voice recognition technology to detect and interpret emotion and linguistics to assess the credibility of insurance claims.

The project is one of 40 backed by £13 million in Government investment to support collaborative industry and research projects to develop the next-generation of professional services.

Business Secretary Greg Clark said: “Artificial intelligence and data are transforming industries across the world.  We are combining our unique heritage in AI with our world beating professional services to put the UK at the forefront of these cutting-edge technologies and their application.

“We want to ensure businesses and consumers benefit from the application of AI – from providing quicker access to legal advice for customers, to tackling fraudulent insurance claims, these projects illustrate our modern Industrial Strategy in action. We’re investing record levels in research and development so that every part of the UK can benefit from the industries and high-skilled jobs of the future.”

The projects announced on February 15 back innovation in the accountancy, insurance and legal services and are part of the Next Generation Services Industrial Strategy Challenge Fund. This is a £20 million fund, administered by UK Research and Innovation (UKRI), to support the development and adoption of AI and Data technologies that will transform the UK’s services industries.

This announcement builds on reviews that BEIS has undertaken with the InsurTech (insurance technology) and LawTech (legal technology) emerging sectors, in partnership with Treasury and the Ministry of Justice.

The Industrial Strategy sets out Grand Challenges to put the UK at the forefront of the industries of the future, ensuring that the UK takes advantage of major global changes, improving people’s lives and the country’s productivity. Artificial intelligence and data is one of the four Grand Challenges which will see AI used across a variety of industries and put the UK at the forefront of the AI and data revolution.

Beverly Hills Orthopedist Pleads Guilt to Comp Fraud

A Beverly Hills workers’ compensation orthopedic surgeon has pleaded guilty to two felony counts of billing fraud for selling marked-up goods to his practice from his own medical supply company over several years.

Gil Tepper M.D. is permanently disqualified from being a provider in the workers’ compensation system and is prohibited from operating any physician-owned medical supply distribution company.

Tepper was ordered to pay more than $1.7 million in restitution to nine insurance companies. The defendant was also sentenced to six months of electronic monitoring and must complete 300 hours of community service.

About $1.1 million in restitution will be paid from Tepper’s frozen funds and he must pay the remaining amount by sentencing on Jan. 28, 2020. If Tepper doesn’t comply with the terms of the plea agreement, he faces a possible maximum sentence of six years in state prison.

According to his arrest warrant, Tepper created and founded Metalink Distributors, which held itself out to be a manufacturer and supplier of medical hardware products. Prosecutors claimed Tepper employed an alleged co-conspirator Dr. Jorge Vital as the Director of Patient Financial Services for MMMC.

During a 2016 raid, officials seized records showing that Tepper used Metalink as a fraudulent shell company to receive healthcare reimbursement payments from insurance companies and government programs through workers’ compensation claims.

MMMC allegedly purchased surgical hardware implants and medical devices from FDA registered surgical hardware suppliers, distributers and manufacturers. Then Vital and Tepper allegedly made it appear that MMMC purchased its surgical hardware from Metalink by creating Metalink invoices with grossly inflated costs, with an average markup 300% over the actual costs.

But MMMC never ordered nor received surgical hardware from Metalink. Vital supposedly instructed MMMC employees to submit the misleading Metalink invoices to numerous insurance companies, including Liberty Mutual, Sedgwick, Farmers, ICW Group Insurance Companies, and Berkshire Hathaway Homestate Companies.

Tepper testified in his deposition in 2012 that he was not aware where Metalink ordered their surgical hardware from and denied ever owning Metalink.

His co-defendant, Jorge Antonio Vital ,is charged with eight counts of workers’ compensation insurance fraud and one count each of conspiracy to commit a crime and attempted perjury under oath, all felonies. The charges include an allegation of taking property valued at more than $3.2 million.

A pre-preliminary hearing for Vital is scheduled for Feb. 19 in Department 50 of the Foltz Criminal Justice Center.

The case was investigated by the District Attorney’s Bureau of Investigation. Case BA456262 was prosecuted by Head Deputy District Attorney Jennifer Lentz Snyder of the Healthcare Fraud Division.

CDI Arrests So. Cal. Podiatrist for Comp Fraud

Licensed podiatrist, Schlomo Schmuel,DPM, 53, of Sherman Oaks, self-surrendered to California Department of Insurance detectives on two felony counts of fraud after allegedly inflating bills and billing for services not rendered or not medically necessary.

The resulting loss to an insurer totaled more than $360,000.

Schmuel operated two businesses, Innovative Orthopedic Solutions and Diamond Orthopedic Services.

While running these two businesses, Schmuel allegedly billed for a hot/cold water unit, also known as a Vital Wrap System, using two combined Healthcare Common Procedure Coding Systems (HCPCS) codes.

The hot/cold unit, used to reduce pain and swelling after undergoing surgery, is a single component and requires only one HCPCS code. By using the two different codes, Schmuel allegedly inflated the invoices and billed for services not rendered.

Department investigators allege Schmuel was also involved in an unlawful kickback scheme where he paid to have the hot/cold water unit prescribed to injured workers, despite it not being medically necessary.

Schmuel allegedly paid a “marketer” $100 for each unit that was prescribed by another medical provider who treated the injured workers with the unit provided by Schmuel.

Schmuel was booked into the Clara Shortridge Foltz Criminal Justice Center.

“This medical professional allegedly used his position of trust to have unneeded medical treatment prescribed to patients in order to scam hundreds of thousands from insurers,” said Insurance Commissioner Ricardo Lara. “My department will continue to investigate fraud and work with our law enforcement partners to ensure California consumers and insurers are protected.”

The Los Angeles County District Attorney’s Office is prosecuting this case.

UCLA Reports on Emerging Transportation Injury Risks

The CDC reports that millions of workers drive or ride in a vehicle as part of their jobs, and motor vehicle crashes are the leading cause of work-related deaths in the United States. All workers are at risk of crashes, whether they drive light or heavy vehicles, or whether driving is a main or incidental job duty. And, the risk of industrial transportation related injury will likely increase according to a new UCLA study of an emerging urban transportation phenomena.

West Los Angeles is the epicenter of the electric scooter phenomenon — Santa Monica was one of the first U.S. cities in which the scooters were widely used — but the vehicles are now available in more than 60 cities nationwide and about a half dozen locations outside of the U.S.

UCLA researchers reporting in the JAMA Network, have found that people involved in electric scooter accidents are sometimes injured badly enough — from fractures, dislocated joints and head injuries — to require treatment in an emergency department.

The researchers examined data from 249 people who were treated at the emergency departments of UCLA Medical Center, Santa Monica, and Ronald Reagan UCLA Medical Center between Sept. 1, 2017, and Aug. 31, 2018. The study found that about one-third of them arrived by ambulance, an indication of the severity of their injuries.

There are thousands of riders now using these scooters, so it’s more important than ever to understand their impact on public health,” said Dr. Tarak Trivedi, the study’s lead author, an emergency physician and scholar in the National Clinician Scholars Program at the David Geffen School of Medicine at UCLA.

The research, published Jan. 25 in JAMA Network Open, is the first published study on injuries caused by electric scooters. It reports that the most common mechanisms of injury among scooter riders were falls (80 percent), collisions with objects (11 percent), or being struck by a moving vehicle such as a car, bicycle or other scooter (9 percent).

E-scooters can reach speeds of about 15 miles per hour, and it has become common to see them zipping along streets and sidewalks — even though they are intended to be used on streets only — often dodging pedestrians and motorists. Unused scooters are frequently left at the edge of curbs, but they sometimes are abandoned in places where they obstruct sidewalks or block building entrances.

Cities have adopted a hodgepodge of responses to the safety issues posed by the new phenomenon. For example, in August 2018, Santa Monica began a public safety campaign with Bird and Lime, two of the leading e-scooter suppliers. A month later, the city launched a pilot program intended to develop administrative regulations on shared scooters and bikes. (Santa Monica already has a longstanding rule prohibiting bikes and electric devices from sidewalks.)

The authors wrote that the Segway, a two-wheeled personal transporter that was introduced in the early 2000s, and a precursor of the scooters, also carried a serious risk for orthopedic and neurologic injuries.

So. Cal. Bio Lab Resolves Fraud Claims for $2M

GenomeDx Biosciences Corp. has agreed to pay $1.99 million to resolve allegations that it violated the False Claims Act, 31 U.S.C. §§ 3729 et seq., by submitting false claims to Medicare for its “Decipher®” post-operative genetic test for prostate cancer patients. GenomeDx is a genomic testing company with operations based in San Diego and headquarters in Vancouver, British Columbia.

The United States alleged that GenomeDx submitted claims to Medicare between September 2015 and June 2017 for the Decipher test that were not medically reasonable and necessary because the prostate cancer patients did not have risk factors necessitating the test, namely pathological stage T2 disease with a positive surgical margin, pathological stage T3 disease, or rising Prostate-Specific Antigen (“PSA”) levels after an initial PSA nadir.

“The Department of Justice is committed to ensuring that Medicare patients only receive laboratory testing that is reasonable and necessary for the individual patient,” said Assistant Attorney General Joseph A. Hunt.  “Medically unnecessary and unproven testing increases costs for federal health care programs and is not in the interest of patients.”

“As this settlement demonstrates, we are committed to protecting the integrity of the Medicare program and will hold health care providers accountable under the False Claims Act when they engage in improper billing,” said Robert S. Brewer, Jr., United States Attorney for the Southern District of California. “This settlement is also another example of our commitment to vigorously investigate cases brought to our attention by whistleblowers. We commend the two employees of GenomeDx who had the courage to come forward and work with investigators.”

“Lab tests and other medical services should only be conducted or provided when medically necessary,” said Christian J. Schrank, Special Agent in Charge for the Office of Inspector General of the U.S. Department of Health and Human Services.  “Whistleblowers play a critical role in keeping entities honest and accountable, and are encouraged to report suspected waste, fraud and abuse by those billing federal healthcare programs.”

“The message is clear, if you take advantage of programs like Medicare, you will be held accountable,” said John Brown, FBI Special Agent-in-Charge.  “Companies who engage in filing false claims to generate more corporate revenue are not only stealing from the federal taxpayer, but also from people who rely on federally funded programs for their health care needs.”

The False Claims Act allegations being resolved were originally brought in a lawsuit filed by two former employees of Genome DX, Stephanie LaFleur and Corrine Vause, under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens with knowledge of fraud against the government to bring suit on behalf of the government and to share in any recovery. The whistleblowers will receive approximately $350,000 of the settlement proceeds of $1,990,380.

The investigation was conducted by the Civil Division of the Department of Justice, the U.S. Attorney’s Office for the Southern District of California, the Department of Health and Human Services Office of Inspector General, and the Federal Bureau of Investigation.

Cal Employers Face FEHA Expansion

Last fall, Governor Edmund G. Brown Jr. signed SB 1300 (Jackson; D-Santa Barbara), a comprehensive bill that makes several changes in the law for making sexual harassment claims.

The bill also amends FEHA to specify that an employer may be responsible for the acts of nonemployees for all forms of harassment, rather than the responsibility being limited to sexual harassment, as it was before SB 1300 took effect.

Further, the bill prohibits a prevailing defendant from being awarded fees and costs unless specific conditions are met.

SB 1300 prohibits employers from requiring employees to sign a release of claims under the Fair Employment and Housing Act (FEHA) in exchange for a raise or as a condition of employment.

These provisions took effect on January 1, but employers and defense counsel need to be aware of the bill’s “intent language.”

The broad “intent” language is likely inconsistent with canons of statutory construction and prior court precedent. As such, SB 1300’s intent language will surely increase employer costs as lawyers attempt to erroneously utilize the “findings and declarations” in SB 1300 to expand FEHA litigation.

The general rule of statutory construction is to effectuate the intent of the Legislature, which basically requires the courts to give the statutory language its usual and ordinary meaning. A statute is changed by a material amendment to the statutory language itself, but not by “legislative intent” language.

One intent declaration concerns the Legislature’s view about whether a single harassment incident still could be considered a violation of FEHA. To quote SB 1300: “the Legislature hereby declares its rejection of the United States Court of Appeals for the 9th Circuit’s [decision] and states that the opinion shall not be used in determining what kind of conduct is sufficiently severe or pervasive to constitute a violation of [FEHA].”

Yet, the author removed from her bill the statutory provisions that would have lowered the severe or pervasive standard.

Another declaration concerns the Legislature’s view that “harassment cases are rarely appropriate for disposition on summary judgment.” However, SB 1300 does not amend Code of Civil Procedure Section 437(c), which sets forth the requirements regarding motions for summary judgment. However, SB 1300 does not amend Code of Civil Procedure Section 437(c), which sets forth the requirements regarding motions for summary judgment.

Additionally, the intent language of SB 1300 seeks to lower the legal standard for hostile work environment claims by referring to a single quote by a single justice’s concurring opinion in a U.S. Supreme Court 9-0 decision: :the Legislature affirms its approval of the standard set forth by Justice Ruth Bader Ginsburg in her concurrence that, in a workplace harassment suit, ‘the plaintiff need not prove that his or her tangible productivity has declined as a result of the harassment.’”

Given that SB 1300 did not change the statutory standards for summary judgment and hostile work environment, the superfluous intent language in SB 1300 does not serve to provide guidance regarding either of these standards. As the U.S. Supreme Court has stated, “We are governed by laws, not by the intentions of legislators.”

Study Claims Surgery is a Leading Cause of Death

A new study claims that surgery is a leading cause of death. The findings were published in a research letter to The Lancet medical journal.

About 4.2 million people worldwide die every year within 30 days of surgery — more than from HIV, tuberculosis and malaria combined, a new study reports.

The findings show that 7.7 percent of all deaths worldwide occur within a month of surgery, a rate higher than that from any other cause except ischemic heart disease and stroke.

About 313 million surgical procedures a year are performed worldwide, according to The Lancet Commission on Global Surgery, but little is known about the quality of surgery around the world. That’s what this study set out to explore, using available data on volume and type of procedures and death rates.

Surgery has been the ‘neglected stepchild’ of global health and has received a fraction of the investment put in to treating infectious diseases such as malaria,” said lead author Dr. Dmitri Nepogodiev. He’s a research fellow at the University of Birmingham in England.

Along with finding that 4.2 million people a year die within a month of having surgery, his team discovered that half of those deaths occur in low- and middle-income countries.

Researchers from Birmingham’s NIHR Global Health Research Unit on Global Surgery said 4.8 billion people worldwide lack timely access to safe and affordable surgery. They estimated that there is an unmet need for 143 million surgical procedures a year in low- and middle-income countries.

But answering unmet needs those countries would increase the worldwide number of postoperative deaths to 6.1 million a year, the investigators said.

Although not all postoperative deaths are avoidable, many can be prevented by increasing investment in research, staff training, equipment and better hospital facilities,” Nepogodiev said in a university news release. “To avoid millions more people dying after surgery, planned expansion of access to surgery must be complemented by investment in to improving the quality of surgery around the world,” he noted.