Tag: 2019 News

The genetic-screening sales reps turn out at health fairs, houses of religion, parks and elder enclaves, offering seniors a chance to learn if they or their loved ones are at risk of developing cancer. All they need, the reps say, is a free cheek swab.

Reuters reports that, U.S. federal investigators say, some of the sales representatives are part of a burgeoning industry that threatens to become what multiple government investigators call the next big frontier in healthcare fraud: genetic testing, which is reaping millions of dollars from unnecessary tests that target senior citizens.

Shimon Richmond, assistant inspector general for investigations with the Office of Inspector General for the Department of Health and Human Services, said his office has seen a steady stream of complaints into genetic testing. In 2018, the inspector general’s office received about one or two complaints per week. Now, he said, the fraud hotline burns with as many as 50 calls weekly.

“We have investigations going on in this space across the country. It is not limited to one geographic region,” Richmond said in an interview. “This is touching every corner.”

In all, more than 300 federal investigations, conducted by multiple law enforcement agencies, are examining genetic testing fraud schemes, said a law enforcement official who spoke on condition of anonymity because the inquiries are not yet public. The investigative crush was sparked in part by unusual Medicare billing data patterns that started to emerge in 2015.

In the United States, genetic testing has skyrocketed. For Medicare, the public insurance program for elderly and disabled Americans, payouts for genetic tests jumped from $480 million in 2015 to $1.1 billion in 2018, a Reuters analysis found. Those figures do not include invoices for spending by state Medicaid programs, which serve the poor, or supplemental Medicare insurance programs offered by private insurers.

The investigations are examining billings submitted to federal health insurance programs. By law, all diagnostic lab tests must be ordered by a doctor treating a patient for a specific condition.

In the cases under review, investigators and patients told Reuters, marketers get elderly residents to turn over their Medicare or Medicaid information, along with their driver’s license and other identifying information, and tell them they will take a free cheek swab that can help them understand their risks of developing cancer or whether their genetics could unlock clues about how they will respond to drug treatments. They then get a doctor to sign off and approve the test and ship the swab off to a lab, which seeks Medicare payouts.

But many of the lab tests are not relevant to the patient’s history, and some of the doctors sign off on the results without conferring with the patient, said investigators familiar with the operations and patients interviewed by Reuters. Suspect companies pocket thousands, with a cut going to doctors, but the seniors get little, if any, benefit, investigators say.

Brian Benczkowski, the assistant attorney general for the U.S. Department of Justice’s Criminal Division, estimated that fraudulent billings submitted over the last few years are expected to total “north of $1 billion.” He called genetic testing of the elderly “the next big frontier in federal healthcare fraud enforcement.”

A little-explored world surrounds the marketing companies, laboratories and telemedicine companies involved in elder genetic testing. Among them is Spectrum. Another is Clio Laboratories, the Georgia-based lab that is part of an interconnected network of labs, medical billing operations, a telemedicine firm and other healthcare-related limited liability companies, company records show.

In a handful of cases, the patients who had DNA samples sent to Clio or Spectrum said they never spoke with a doctor about why the cancer or pharmacogenetic tests were medically necessary. Moreover, when test results were completed, they were mailed directly to patients’ homes. That is not the norm, say doctors and medical experts. Usually, the ordering physician receives results first, then reviews them with the patient.

In 2017, the most recent data available, Clio billed Medicare $8.6 million for genetic testing and was paid about $4.6 million.

Some of the doctors involved in the genetic testing wave also have checkered pasts.  One California doctor was signing off on genetic tests for patients even as two states had disciplined him or were preparing to do so after he was criminally convicted in Los Angeles.

Orthopedic surgeon Dr. Mitchell G. Cohen pleaded guilty in November 2015 to filing a false tax return in connection with an illegal kickback scheme, cooperated with the government’s investigation, and later served more than eight months in a halfway house in central California through March 2019, court records show. Cohen was not charged with making an illegal kickback, but pleaded guilty to making a false tax return in a case federal authorities said involved kickbacks.

Cohen was approving genetic tests for Medicare patients during his stint in the halfway house and after his probation period ended. He approved the medical necessity of genetic tests handled by labs including BioConfirm in Georgia and Elite Medical Laboratories, lab records show.  He signed off on the genetic test for Elite in September 2018, as he was serving his sentence in the halfway house, records show. He approved the medical necessity of tests sent to Bioconfirm on May 10, 2019.

Studies continue to show that artificial intelligence is on a par with human experts when it comes to making medical diagnoses based on images.

The potential for artificial intelligence in healthcare has caused excitement, with advocates saying it will ease the strain on resources, free up time for doctor-patient interactions and even aid the development of tailored treatment. Last month the UK announced £250m of funding for a new NHS artificial intelligence laboratory.

However, experts have warned the latest findings are based on a small number of studies, since the field is littered with poor-quality research.

One burgeoning application is the use of AI in interpreting medical images – a field that relies on deep learning, a sophisticated form of machine learning in which a series of labelled images are fed into algorithms that pick out features within them and learn how to classify similar images. This approach has shown promise in diagnosis of diseases from cancers to eye conditions.

However questions remain about how such deep learning systems measure up to human skills. Now researchers say they have conducted the first comprehensive review of published studies on the issue, and found humans and machines are on a par.

Prof Alastair Denniston, at the University Hospitals Birmingham NHS foundation trust and a co-author of the study, said the results were encouraging but the study was a reality check for some of the hype about AI.

Dr Xiaoxuan Liu, the lead author of the study and from the same NHS trust, agreed. ‘There are a lot of headlines about AI outperforming humans, but our message is that it can at best be equivalent,’ she said.

Writing in the Lancet Digital Health, Denniston, Liu and colleagues reported how they focused on research papers published since 2012 – a pivotal year for deep learning.

An initial search turned up more than 20,000 relevant studies. However, only 14 studies – all based on human disease – reported good quality data, tested the deep learning system with images from a separate dataset to the one used to train it, and showed the same images to human experts.

The team pooled the most promising results from within each of the 14 studies to reveal that deep learning systems correctly detected a disease state 87% of the time – compared with 86% for healthcare professionals – and correctly gave the all-clear 93% of the time, compared with 91% for human experts.

However, the healthcare professionals in these scenarios were not given additional patient information they would have in the real world which could steer their diagnosis.

Prof David Spiegelhalter, the chair of the Winton centre for risk and evidence communication at the University of Cambridge, said the field was awash with poor research.

“This excellent review demonstrates that the massive hype over AI in medicine obscures the lamentable quality of almost all evaluation studies,” he said. “Deep learning can be a powerful and impressive technique, but clinicians and commissioners should be asking the crucial question: what does it actually add to clinical practice?”

However, Denniston remained optimistic about the potential of AI in healthcare, saying such deep learning systems could act as a diagnostic tool and help tackle the backlog of scans and images. What’s more, said Liu, they could prove useful in places which lack experts to interpret images.

Liu said it would be important to use deep learning systems in clinical trials to assess whether patient outcomes improved compared with current practices.

A Huntington Beach doctor with a history of legal and disciplinary problems is one of the 25 people accused of participating in a Medicare fraud scheme that netted about $150 million through fraudulent insurance claims, according to federal prosecutors.

74 year old Nagesh Shetty, was just indicted in connection with the scheme, which involved “medically unnecessary” cardiac treatments and testing through an Inglewood healthcare provider, Global Cardio Care.

Shetty was first licensed by the California Medical Board in 1979 and has operated practices in Costa Mesa, West Covina and the West Hills neighborhood of Los Angeles, according to documents and online records.

In 1994, Shetty was indicted in federal court on 28 counts of mail fraud on allegations of defrauding a Minnesota-based insurance company through nonexistent, medically unnecessary or excessive medical treatment.”That case was later transferred to a California district court and charges were eventually dropped, court records show.

In 1996, Shetty was sentenced to 21 months in federal prison and fined $40,000 for filing false income tax returns and failing to report more than $400,000 in income over a three-year period in the 1980s, court documents show. At the time of the crimes, Shetty was owner and attending physician of Harbor Newport Medical Clinic in Costa Mesa.

While in prison, Shetty was indicted in 1998 on federal charges alleging that he defrauded military and private health insurance programs.

In 2000, a jury convicted Shetty of 26 felony counts of mail fraud and he was sentenced to two years in prison and three years’ supervised release, court records show. He also was ordered to pay restitution, including more than $28,000 to the U.S. Treasury and more than $19,000 to Blue Cross Blue Shield, court records show.

The California Medical Board revoked Shetty’s license in 2000, according to board records. His license to practice medicine also was revoked in New York in 1999 and Washington state in 2001, records show.

In 2005, Shetty petitioned the California board to reinstate his medical certificate. At the time, Shetty was bagging groceries and stocking shelves at a store and said his inability to practice his profession had caused emotional and financial strain for his wife and four children.

He was granted a probationary license, according to a decision by an administrative law judge, with the conditions that he complete an ethics course and a clinical training program, undergo monitoring and be barred from practicing solo, supervising physician assistants and handling any billing matters.

In 2009, Shetty completed his probation and the board reinstated his license.

In a disciplinary order effective April 26 2019, the board issued Shetty a public reprimand stemming from a case in which he was accused of repeated negligence and failure to maintain adequate and accurate records involving a patient in 2016, according to California Department of Consumer Affairs records.

And now he faces charges for his 2019 arrest!

The court of appeal ruled on a case between CIGA and the Travelers that upheld the endorsement on the Travelers policy limiting its coverage for special employees in a general special employment situation.

In the unpublished case of Travelers v WCAB, and CIGA, two employers agreed that the general employer, StaffChex, vwould obtain workers’ compensation insurance for employees it leased to the special employer Jessie Lord Bakery. Relying on this agreement, the special employer obtained workers’ compensation insurance from Travelers for its own employees with a “limiting endorsement” excluding coverage for special employees.

These agreements were in place for several years when a special employee, Jose Luis Mastache, was injured on the job while assigned to the special employer. The general employer’s insurer, Ullico Casualty Company, thereafter became insolvent and California Insurance Guarantee Association (CIGA) took over the administration of the claim.

Although there was a written endorsement attached to the Traveler’s policy excluding coverage for special employees, and the special employee’s carrier was informed the general employee had obtained the required workers’ compensation insurance, the Workers’ Compensation Appeals Board invalidated the Travelers limiting endorsement because the limiting endorsement had not been signed by the special employer. The written affirmation was required under WCAB Rules, section 2259(e) in effect at the time the Travelers policy was written.

Thus, Travelers, the insurer for the special employer was ordered to bear all liability for compensation to the injured worker when the general employer’s insurer became insolvent. This obligated Travelers to pay the entire claim since CIGA had shown there was “other” insurance in effect. Travelers appealed and the court of appeal reversed the WCAB in the unpublished case.

The question of whether Travelers is “other insurance,” relieving CIGA of liability, turns on whether the endorsement in the Travelers policy is valid.

The court of appeals made the observation that it was addressing a commercial relationship between two relatively sophisticated parties and a third sophisticated insurance company who embarked on a course of dealing that had been in place for a number of years before Mastache was injured.This entire structure was set aside by the appeals board, ostensibly over the absence of a signature by Jessie Lord on the endorsement to the contract with Travelers, even though this contractual structure had been functioning for three years when Mastache was injured.

The parties complied with the applicable regulatory requirements and it is undisputed that they complied with their contractual commitments to one another. They performed these contractual commitments for several years. The court of appeals concluded that the appeal board’s decision was thus unreasonable and inequitable.

“Nullifying a three-sided, sophisticated contractual structure, under which all three parties performed their obligations in good faith over the absence of a signature on an endorsement to a contract disregards reality and is inequitable.”

A local health care fraud enforcement action has resulted in federal charges against of 25 Southern California defendants for their alleged involvement in healthcare fraud schemes that fraudulently sought over $150 million from the Medicare and Medicaid programs, as well as private insurers and union health benefit plans. Fourteen of those charged in federal court in Los Angeles and Santa Ana are doctors or medical professionals.

A total of 10 cases have been announced. Those charged are:

Dr. Ronald Weaver, 70, of Pacific Palisades; Sara Soulati, 49, of Santa Monica; Dr. John Weaver, 75, of Alhambra; Dr. Ronald Carlish, 78, of Pacific Palisades; Dr. Howard Elkin, 68, of Whittier; Dr. Wolfgang Scheele, 79, of Los Angeles; and Dr. Nagesh Shetty, 74 of Huntington Beach, who were charged for their alleged participation in an approximately $135 million scheme to defraud Medicare through medically unnecessary cardiac treatments and testing through Global Cardio Care of Inglewood.

Navid Vahedi, 40, of Los Angeles; Vahedi’s pharmacy, Fusion Rx Compounding Pharmacy; and Joseph S. Kieffer, 39, a marketer, of Los Angeles, who were charged in a fraud and kickback scheme. Vahedi and Kieffer, allegedly paid commissions to marketers and some patients to obtain medically unnecessary compounded drugs to allow Fusion Rx to bill health care providers for those compounded drugs, many of which were reimbursed at rates much higher than average medications.

Hilda Haroutunian, 59, of Sun Valley; Dr. Keyvan Amirikhorheh, 60, of Seal Beach; Lorraine Watson, 56, a physician’s assistant, of Valley Village; Noem Sarkisyan, 63, of North Hollywood; and Edmond Sarkisyan, 40, a medical assistant, of North Hollywood, who were charged for their alleged participation in an approximately $10 million scheme to defraud the Family Planning, Access, Care and Treatment (Family PACT) program administered by Medi-Cal, the California Medicaid program, through fraudulent claims for family planning services, testing and prescriptions for non-existent patients submitted through Los Angeles Community Clinic and associated diagnostic testing laboratories and pharmacies.

Amir Friedman, 54, an anesthesiologist, of Calabasas, who is charged for his alleged participation in a conspiracy to commit honest services mail and wire fraud and Travel Act violations involving approximately $800,000 in kickbacks for compounded pharmaceutical drugs involving New Age Pharmaceuticals, Inc., in Beverly Hills.

Susan H. Poon, 54, a chiropractor who resides in Dana Point, who was arrested after a federal grand jury charged her in an approximately $2 million scheme to defraud Anthem, Aetna, and other Blue Cross Blue Shield Association affiliates, including the Teamsters Western Region and Local 177 health care plans.

Antonio Olivera, 78, of Downey; Emelita Cephass, 57, of Downey; and Martin Canter, 70, of Rancho Palos Verdes, who were charged for their alleged participation in a hospice kickback scheme.

Mahyar David Yadidi, 37, a chiropractor who resides in Los Angeles, who was charged with conspiracy to commit health care fraud for operating a scheme to defraud the International Longshore and Warehouse Union – Pacific Maritime Association health care benefit plan.

Darren Hines, 49, a chiropractor who lives in the Harbor City neighborhood of Los Angeles, who was charged with health care fraud for operating a scheme to defraud the International Longshore and Warehouse Union – Pacific Maritime Association health care benefit plan.