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Tag: 2019 News

Medical Marijuana No Help for Opioid Crisis

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Legalizing medical marijuana no longer appears to be linked with a drop in fatal opioid overdoses, according to a new U.S. study reviewed by Reuters Health, that calls into question the potential for cannabis to help fix the opioid crisis.

In recent years, many advocates for legalizing marijuana – including some doctors and public health officials – have cited a pivotal 2014 study that found lower rates of fatal opioid overdoses from 1999 to 2010 in the states that legalized medical marijuana.

For the current study, published in the Proceedings of the National Academy of Sciences, researchers used similar methods to take another look at the same period examined in the 2014 study and extend the analysis through 2017, to include many states that only recently legalized medical marijuana.

The new study found a similar result for the same period covered in that 2014 study: about a 21 percent decrease in opioid overdose deaths for every 100,000 people in the population when states legalized medical marijuana.

But when the new study looked over more time – from 1999 to 2017 – they found an almost 23 percent increase in opioid overdose deaths in states with medical marijuana laws.

“With the benefit of a longer time span … we conclude that medical cannabis laws do not seem to have reduced opioid overdose mortality at the population level,” said lead study author Chelsea Shover of Stanford University School of Medicine in California.

Like the 2014 study, the new analysis can’t show whether people are using marijuana instead of opioids for pain relief or recreation, Shover said by email. And these studies also weren’t designed to determine the safety or effectiveness of medical marijuana for any specific health issues.

The current study didn’t find a difference in opioid deaths associated with legalized marijuana based on how permissive or restrictive state laws might be, or whether states allowed only medical pot or also permitted recreational use.

California became the first state to legalize medical marijuana in 1996. Today 47 states permit some version of medical pot.

It’s possible that the connection between marijuana laws and opioid overdose deaths has shifted over time due at least in part to differences in the characteristics of the states that did this years ago and states that did this only recently, the study authors note.

“States that legalized medical cannabis early formed a group that was pretty different from the rest of the U.S.,” Shover said.

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Patients Happier in Small Hospitals with Amenities

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Compared to smaller facilities, hospitals that provide complex care for critical illness or serious injury may find it harder to make patients happy.

The new study reviewed by Reuters Health suggests.that patients may be more likely to give top ‘5-star’ ratings to hospitals that don’t offer many commonly sought-after services like emergency rooms and intensive care units.

In an effort to help patients find high quality care, the U.S. Centers for Medicare and Medicaid Services (CMS) publishes hospital rankings based on patients’ experiences, on a website called Hospital Compare. But research to date hasn’t offered a clear picture of how much patients’ ratings, on a scale of 1 to 5, might help people find the best place to go for care, researchers note in JAMA Internal Medicine.

In the current study, researchers examined services offered and patient experience ratings for 2,798 hospitals nationwide. Compared to hospitals with lower ratings, hospitals with 5 stars were 84 to 92 percent less likely to provide emergency services, intensive care, cardiology or neurology, the study found.

These results suggest that patients shouldn’t rely exclusively on 5-star ratings to choose where to seek care, said lead study author Dr. Zishan Siddiqui of Johns Hopkins School of Medicine in Baltimore.

“This is especially true for patients with multiple medical problems and chronic illness. They are much less likely to receive comprehensive services when admitted,” Siddiqui said by email. “Hospital patient experience rating systems in general should be just one of many hospital metrics patients should look at when selecting hospitals.”

“Patient experience performance ratings are a relationship between communication and responsiveness needs of the patients and how well the hospitals perform to meet these needs,” Siddiqui added.

“If a hospital has patients only with simpler communication and responsiveness needs, they may meet these needs without necessarily performing at a higher level,” Siddiqui said. “The 5-star hospitals appear to get higher scores because they are more often taking care of patients with simpler needs.”

Patients who search for only 5-star hospitals when they need complex care may therefore be surprised to find many types of services they need are unavailable at these hospitals, the study team writes.

“Patient experience, driven in part by the hospitality of staff but largely by the quality of hospital amenities, is an important driver of where patients receive care,” Jena, who wasn’t involved in the study, said by email.

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Dentist Faces 75 Charges for 600 Fake Root Canals

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58 year old April Rose Ambrosio, a San Diego dentist, was charged with 75 felony insurance fraud counts for allegedly bilking insurance companies of hundreds of thousands of dollars by submitting claims for procedures she never performed, including more than 600 root canals. Her office was located at 10717 Camino Ruiz # 164, San Diego, CA 92126

She faces 83 years in prison if convicted of all counts.

Prosecutors allege Ambrosio submitted insurance claims for as many as 28 root canals on a single patient, and also submitted claims indicating she had performed more than 100 root canals over a three-month period for a family of four.

According to court documents, an insurance company filed a suspected fraud form with the California Department of Insurance in December 2016 over the unusually high number of root canals performed on that family, and Ambrosio’s failure to provide supporting documentation for the dental work.

Ambrosio is accused of defrauding eight insurance companies in the alleged billing scheme, which took place over the course of three years. Though she received around $300,000, according to the Department of Insurance, prosecutors say she billed the insurance companies for nearly $600,000.

She remains out of custody on her own recognizance, but Superior Court Judge Laura Parsky ordered Ambrosio to surrender her passport. The judge also imposed a Fourth Amendment waiver, which means Ambrosio is subject to law enforcement searches, even without a warrant.

She pleaded not guilty to all counts and is due back in court Sept. 5 for a readiness conference.

“The audacity of this defendant’s repeated fraud is astounding,” San Diego County District Attorney Summer Stephan said. “Unfortunately, when insurance companies get ripped off, consumers ultimately pay the price through higher premiums.”

Investigators from the state Department of Insurance, working with the insurance fraud division of the San Diego County District Attorney’s Office, spent two years investigating Ambrosio.

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Double Dipping Business Owner Sentenced

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The Ventura County District Attorney announced that Charles Ruben (DOB 9/13/1951), formerly of Simi Valley, was placed on summary probation for a period of 36 months after pleading guilty to a violation of Insurance Code section 1871.4(a)(l)-making a fraudulent statement of a material fact for the purpose of obtaining workers’ compensation benefits.

As a result of the prosecution of this case, Ruben paid restitution in full to victim State Compensation Insurance Fraud in the amount of $41,326, and, to victim 1st Class Access Control in the amount of $3,811.

Ruben was placed on disability for an injury sustained while employed at 1st Class Access Control in Simi Valley.

During that time, he collected disability payments that totaled $34,981 and systematically failed to report that he earned $48,686 while working as a self-employed contractor.

He was President of Cr’s Gate Service, Inc. Cr’s Gate Service, Inc. is a California Domestic Corporation filed on March 9, 2006. The company’s filing status is listed as Suspended and its File Number is C2869102. The Registered Agent on file for this company is Charles Ronald Ruben and was located at 1596 Kane Ave, Simi Valley, CA 93065-3625.

In the United States, workers compensation fraud costs insured employers $2 billion annually. The Ventura County District Attorney’s Office is committed to vigorously prosecuting dishonest employees who steal disability benefits they are not entitled to receive.

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Jury Convicts Doctor and Recruiter

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A federal jury has found an East Hollywood-based doctor and patient recruiter guilty for their roles in a $33 million Medicare fraud scheme in which Medicare was billed for clinic, home health, hospice services and durable medical equipment that patients did not need or did not receive.

Following a seven-day trial, Robert A. Glazer, of North Hollywood, the owner and operator of the East Hollywood-based Glazer Clinic, was found guilty of one count of conspiracy to commit health care fraud and 12 counts of health care fraud. Co-defendant Marina Merino, 62, of Los Angeles, a marketer who recruited patients in exchange for kickback payments, was found guilty of one count of conspiracy to commit health care fraud and eight counts of health care fraud.

Glazer and Merino are scheduled to be sentenced on September 9 by United States District Judge Otis D. Wright II. Each defendant faces the possibility of decades in federal prison.

Glazer and Merino were charged in a 2015 superseding indictment, along with Angela Avetisyan, the officer manager of Glazer Clinic and co-owner of Fifth Avenue Home Health located in East Hollywood, and Ashot Minasyan, co-owner of Fifth Avenue.

According to the evidence presented at trial, Merino and other marketers received payments from Avetisyan and Minasyan to recruit Medicare beneficiaries to the Glazer Clinic. Thereafter, Glazer billed Medicare for office services and tests that patients did not need or did not receive.

Glazer also referred Medicare patients for a variety of services, including home health and hospice services, as well as ordered durable medical equipment that patients did not need or did not receive. Based on referrals from Glazer, Avetisyan and Minasyan billed Medicare for home health services that were not rendered or were not medically necessary through their company, Fifth Avenue.

Avetisyan, who worked as an office manager at the Glazer Clinic, also sold Glazer’s referrals to other home health and durable medical equipment agencies. Together, the defendants and their co-conspirators submitted and caused to be submitted claims of approximately $33 million, of which Medicare paid approximately $22 million, the evidence showed.

Avetisyan and Minasyan pleaded guilty to conspiracy to commit health care fraud in October 2018, and are scheduled to be sentenced on June 10.

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Drugmaker Settles Kickback Case – Then Files Bankruptcy

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Drugmaker Insys Therapeutics Inc filed for Chapter 11 bankruptcy protection, about a week after agreeing to pay $225 million to settle a U.S. probe into bribes it paid to doctors for prescribing a powerful opioid medication.

The filing in U.S. Bankruptcy Court in the District of Delaware made Insys the first drug manufacturer to turn to bankruptcy due to legal expenses brought on by accusations of responsibility in the deadly U.S. opioid epidemic. Shares of the company fell nearly 60 percent to 52 cents in premarket trading.

Insys said it intends to continue operating its business, while it pursues the sale of substantially all its assets under a court-supervised sale process.

Chandler, Arizona-based Insys, which manufactured the fentanyl spray Subsys, agreed on June 5 to settle the U.S. Justice Department probe and have a subsidiary plead guilty to fraud charges.

A month earlier, a federal jury in Boston found Insys founder John Kapoor and four other former executives and managers guilty of engaging in a vast racketeering conspiracy.

Prosecutors alleged that while Kapoor served as Insys’ chairman, the company paid doctors and other medical practitioners bribes in exchange for prescribing Subsys to their patients, often to those who did not have cancer.

Insys did so by paying medical practitioners to act as speakers at sham events ostensibly meant to educate clinicians about Subsys.

Prosecutors said the scheme helped boost sales of Subsys, whose net revenue grew from $8.6 million in 2012 to $329 million in 2015. Insys went public in 2013 with what became the best-performing initial public offering of that year.

The Justice Department probe led to multiple people being charged including Kapoor, the company’s majority shareholder, in October 2017 on the same day U.S. President Donald Trump declared the opioid crisis a public health emergency.

The investigation took a toll on Insys and sales of Subsys declined. In May, Insys said it had just $87.6 million in cash at the end of the first quarter and $240.3 million in liabilities.

The company said on Monday it intends to pay vendors and suppliers in full for goods and services provided after the filing date of June 10.

Other opioid manufactures face lawsuits by state and local governments seeking to hold them responsible for the epidemic, including OxyContin maker Purdue Pharma. Purdue has also considered filing for bankruptcy to address potentially significant liabilities from roughly 2,000 lawsuits, sources told Reuters in March.

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L.A. Dentist Sentenced for $3.8M Fraud Scheme

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A Los Angeles, California-based dentist was sentenced to 40 months in prison for his role in a $3.8 million health care fraud scheme in which he billed numerous dental insurance carriers for crowns and fillings that were never provided to patients.

Benjamin Rosenberg, D.D.S., 59, of Los Angeles, was sentenced by U.S. District Judge John A. Kronstadt of the Central District of California, who also ordered Rosenberg to pay $1,414,011.59 in restitution. Rosenberg pleaded guilty on Jan. 31, 2019, to one count of health care fraud.

He was originally charged with six counts of health care fraud and two counts of aggravated identity theft. He had an office at the time located at 8540 S Sepulveda Blvd, Westchester, CA 90045.

As part of his guilty plea, Rosenberg admitted that he submitted and caused to be submitted approximately $3,853,931 in false and fraudulent claims to various insurance companies for dental care that he knew had not been rendered.

Rosenberg further admitted that he submitted these false and fraudulent claims to Denti- Cal (California Medi-Cal Dental Program), Metlife, Anthem, Cigna, Delta Dental, Guardian, LMCO-DHA, United Healthcare and United Concordia (the carriers), which caused the carriers to pay Rosenberg approximately $1,415,011.

Rosenberg was originally licensed by the Dental Board of California in 1988. An Amended Accusation seeking to revoke his license was filed by Kamala Harris the California Attorney General, accused Rosenberg of misconduct dating back to 2010. The Accusation alleged multiple instances of dental insurance fraud.

In September 2017 he submitted a written request to surrender his license to resolve the disciplinary action that was pending. On January 2, 2018 the surrender was accepted and he is no longer licensed as a dentist in California.

This case was investigated by the FBI. Trial Attorney Emily Z. Culbertson of the Criminal Division’s Fraud Section is prosecuting the case.

The Fraud Section leads the Medicare Strike Force, which is part of a joint initiative between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce current anti-fraud laws around the country.

Since its inception in March 2007, the Medicare Fraud Strike Force, which maintains 14 strike forces operating in 23 districts, has charged nearly 4,000 defendants who have collectively billed the Medicare program for more than $14 billion. In addition, the HHS Centers for Medicare & Medicaid Services, working in conjunction with HHS-OIG, are taking steps to increase accountability and decrease the presence of fraudulent providers.

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VA Promotes Telehealth, and E-Record Systems

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The VA Mission Act of 2018 was designed to greatly improve veteran access to VA healthcare. This legislation’s formal name is the VA Maintaining Systems and Strengthening Integrated Outside Networks Act. The Act strengthens VA’s ability to deliver trusted, easy to access, high quality care at VA facilities, virtually through telehealth.

In the past, among of the chief complaints about VA healthcare involved timely scheduling of appointments, care and services. Under the VA Mission Act, the Department of Veterans Affairs is required to coordinate timely care including help for those who need VA medical services outside their region of residence.

The Act authorizes VA providers to use telehealth technologies to deliver care over state lines and into Veteran’s home, allowing VA to enhance the accessibility, capacity, and quality of VA health care. It also directs VA to implement a pilot program to establish mobile deployment teams to address and improve care in underserved areas.

As part of this process, VA is establishing access standards and standards for quality that will apply to VA facilities and community providers. The proposed access standards were announced January 30. They are based on analysis of best practices in government and the private sector and tailored to the needs of Veterans.

Veterans who access community care can expect a familiar process with several improvements through a new urgent care benefit, expanded eligibility criteria, and improved quality of care. Community providers can expect their interaction with VA will get easier with new IT systems, better communications, and more timely payments.

The VA says it is leading the health care industry in transparency by enabling Veterans to compare data across VA and the private sector so they can make informed decisions when selecting a provider. As Secretary Wilkie said in a recent statement, “we are giving Veterans the power to choose the care they trust, and more Veterans are choosing VA for their health care than ever before.”

Dr. Melissa Glynn serves as the assistant secretary for Enterprise Integration (OEI) and is responsible for leading efforts to continuously improve VA operations. Her office focuses on enhancing Veterans and employee experiences through effective enterprise integration and execution support of people, processes, technology, innovations and maturing management capabilities.

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Another Opioid Manufacturer Pleads Guilty to Kickbacks

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Opioid manufacturer Insys Therapeutics agreed with the government to a global resolution to settle the government’s separate criminal and civil investigations.

As part of the criminal resolution, Insys will enter into a deferred prosecution agreement with the government, Insys’s operating subsidiary will plead guilty to five counts of mail fraud, and the company will pay a $2 million fine and $28 million in forfeiture.  As part of the civil resolution, Insys agreed to pay $195 million to settle allegations that it violated the False Claims Act.

Both the criminal and civil investigations stemmed from Insys’s payment of kickbacks and other unlawful marketing practices in connection with the marketing of Subsys. Insys’s drug Subsys is a sublingual fentanyl spray, a powerful, but highly addictive, opioid painkiller.

In April 2018, the United States intervened in five qui tam lawsuits accusing Insys of violating the civil False Claims Act. In its Complaint, the United States alleged that Insys, headquartered in Arizona, paid kickbacks to induce physicians and nurse practitioners to prescribe Subsys for their patients.

In addition to payments for sham speaker program speeches, the kickbacks also allegedly took the form of jobs for the prescribers’ relatives and friends, and lavish meals and entertainment.

The United States also alleged that Insys improperly encouraged physicians to prescribe Subsys for patients who did not have cancer, and lied to insurers about patients’ diagnoses in order to obtain reimbursement for Subsys prescriptions that had been written for Medicare and TRICARE beneficiaries.

One practitioner targeted by Insys was a physician’s assistant who practiced with a pain clinic in Somersworth, New Hampshire. During the first year that Subsys was on the market, the physician’s assistant did not write any Subsys prescriptions for his patients. In May 2013, the physician’s assistant joined Insys’s sham speaker program knowing that it was a way to receive kickbacks for writing Subsys prescriptions. After joining the sham speaker program, the physician’s assistant wrote approximately 672 Subsys prescriptions for his patients – many of which were medically unnecessary – and in turn, received $44,000 in kickbacks from Insys.

As part of the criminal resolution, Insys agreed to a detailed statement of facts outlining its criminal conduct with respect to the illegal marketing of Subsys. Insys will enter into a five-year deferred prosecution agreement with the government, while Insys’s operating subsidiary will plead guilty to five counts of mail fraud pursuant to the plea agreement that will be filed in the District of Massachusetts.

The allegations resolved by the settlement stem from five lawsuits that were filed under the qui tam, or whistleblower, provisions of the False Claims Act, which permit private citizens to bring suit on behalf of the United States for false claims and share in any recovery.

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HHS Publishes Pain Management Best Practices

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The Pain Management Best Practices Inter-Agency Task Force was established to propose updates to best practices and issue recommendations that address gaps or inconsistencies for managing chronic and acute pain. The U.S. Department of Health and Human Services is overseeing this effort with the U.S. Department of Veterans Affairs and U.S. Department of Defense.

The Task Force has now just published its Final 116 Page Report.

50 million adults in the United States have chronic daily pain, with 19.6 million adults experiencing high-impact chronic pain that interferes with daily life or work activities. However, the Task Force emphasizes the importance of individualized patient-centered care in the diagnosis and treatment of acute and chronic pain.

This report is therefore “broad and deep and will have sections that are relevant to different groups of stakeholders regarding best practices.” It emphasizes the development of an effective pain treatment plan after proper evaluation to establish a diagnosis, with measurable outcomes that focus on improvements, including quality of life (QOL), improved functionality, and activities of daily living (ADLs).

A multidisciplinary approach for chronic pain across various disciplines, using one or more treatment modalities, is encouraged when clinically indicated to improve outcomes. These include the following five broad treatment categories, which have been reviewed with an identification of gaps/inconsistencies and recommendations for best practices:

— Medications: Various classes of medications, including non-opioids and opioids, should be considered for use. The choice of medication should be based on the pain diagnosis, the mechanisms of pain, and related co-morbidities following a thorough history, physical exam, other relevant diagnostic procedures and a risk-benefit assessment that demonstrates that the benefits of a medication outweigh the risks. The goal is to limit adverse outcomes while ensuring that patients have access to medication-based treatment that can enable a better QOL and function. Ensuring safe medication storage and appropriate disposal of excess medications is important to ensure best clinical outcomes and to protect the public health.
— Restorative Therapies, including those implemented by physical therapists and occupational therapists (e.g., physiotherapy, therapeutic exercise, and other movement modalities) are valuable components of multidisciplinary, multimodal acute and chronic pain care.
— Interventional Approaches, including image-guided and minimally invasive procedures, are available as diagnostic and therapeutic treatment modalities for acute, acute on chronic, and chronic pain when clinically indicated. A list of various types of procedures, including trigger point injections, radio-frequency ablation, cryo-neuroablation, neuromodulation, and other procedures are reviewed.
— Behavioral Approaches for psychological, cognitive, emotional, behavioral, and social aspects of pain can have a significant impact on treatment outcomes. Patients with pain and behavioral health comorbidities face challenges that can exacerbate painful conditions as well as function, QOL, and ADLs.
— Complementary and Integrative Health, including treatment modalities such as acupuncture, massage, movement therapies (e.g., yoga, tai chi), and spirituality, should be considered when clinically indicated.

Continued medical and scientific research is critical to understanding the mechanisms underlying the transition from acute to chronic pain; to translating promising scientific advances into new and effective diagnostic, preventive and therapeutic approaches for patients; and to implementing these approaches effectively in health systems.

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