Tag: 2020 News

Disc herniation is a common cause of stenosis and the back and limb pain that it leads to. It occurs when disc nuclear material pushes through a tear in the annulus.

Lumbar discectomy is a common procedure used to remove the disc material that is pressing on nerves or the spinal cord. But reherniation is the most common failure mode for these procedures due to the weakened state of the disc annulus.

A study published in April 2020 in the journal Expert Review of Medical Devices (Expert review with meta-analysis of randomized and nonrandomized controlled studies of Barricaid annular closure in patients at high risk for lumbar disc reherniation“) found that symptomatic reherniation rates after lumbar discectomy with Barricaid were 50% lower than lumbar discectomy without Barricaid.

The market and impact for the device is quite large, with Barricaid’s manufacturer, Intrinsic Therapeutics, estimating 400,000 total lumbar discectomy procedures performed in the U.S. annually, 120,000 of which involve a large defect, which is most likely to herniate and benefit from the use of the Barricaid Annular Closure device.

Intrinsic Therapeutics, Inc. of Woburn, Massachusetts, received FDA approval for Barricaid Annular Closure device in 2019.

The device consists of a metallic anchor connected to a polyester plug that the company refers to as the occlusion component. The anchor is affixed to the vertebral body closest to the annular defect and the occlusion component is inserted into the defect. The device is designed to withstand up to 330psi, which allows for normal anatomical movement.

The Centers for Medicare and Medicaid Services (CMS) listed a new billing code for annular closure (C9757) for which the Barricaid Annular Closure device is the only one that is FDA-approved. The new code went into effect on January 1, 2020.

Additionally, the International Journal of Spine Surgery issued guidance supporting both coding and coverage of the device.

CEO and President of Intrinsic Therapeutics, Cary Hagan said in a recent press release, “We appreciate all the progress that is being made on patient access to Barricaid by leading surgeons and spine specialty societies. With more than 20 insurers now covering Barricaid, together with the support of surgeons and specialty societies, and more than 50 peer reviewed manuscripts, we are confident in our ability to continue delivering needed and cost-effective care for lumbar discectomy patients with large annular defects.”

A judge for the U.S. District Court for the Northern District of California ruled that Amazon.com Inc.’s injury data is not confidential information.

The Center for Investigative Reporting, a journalism nonprofit based in Berkeley, California, filed Freedom of Information Act requests between with the U.S. Occupational Safety and Health Administration, seeking annual data on Amazon’s injuries, illnesses and fatalities at certain warehouses.

OSHA requires employers with more than 10 workers to annually submit data on workplace injuries and illnesses using its Form 300. The log includes the name and title of workers who are injured or contract an occupational illness, along with a description of the injury or illness, and the result of the injury or illness. Employers are required to provide copies of these records to current and former employees and their representatives upon request, and employers must retain the records for five years.

OSHA’s final rule on record keeping also stipulates that an “employer may not require an employee, former employee or designated employee representative to agree to limit the use of the records as a condition for viewing or obtaining copies of records.”

Although OSHA noted in 2016 that public access of this data could encourage employers to abate hazards and prevent injuries and illnesses, in August 2019, OSHA stated that it considered the Form 300 data to be confidential commercial information.

The DOL argued that the Form 300 logs fall under the FOIA exemption that shields from mandatory disclosure any “commercial or financial information obtained from a person.”

Judge Kim, however, disagreed in her 28 page July 6, 2020 Order, holding that Amazon itself had not customarily treated its Form 300 data as confidential, and noted that OSHA regulations require employers, including Amazon, to post such information at its facilities for a three-month period.

Although the DOL also argued that the data could be “misused,” Judge Kim dismissed this argument, noting that employees’ personal and medical information does not appear on the form, and that Amazon’s broad disclosures required under the regulations to all current employees, former employees, and employees’ representatives – with no restrictions on their further disclosures – defeats the DOL’s effort to demonstrate confidentiality.

Kim’s ruling comes just one month after another federal judge in Oakland, California, ruled against the Department of Labor in a similar lawsuit brought by the Center for Investigative Reporting. In that case, U.S. District Judge Donna Ryu ordered the department to release 237,000 workplace injury logs submitted by various employers from Aug. 1, 2017, through Feb. 6, 2018. Like Kim, Ryu also found the companies were already warned the information could be posted on a public website in 2016.

Novartis Pharmaceuticals Corporation has agreed to pay $51.25 million to resolve allegations that it violated the False Claims Act by illegally paying the Medicare co-pays for its own drugs.

When a Medicare beneficiary obtains a prescription drug covered by Medicare Part B or Part D, the beneficiary may be required to make a partial payment, which may take the form of a co-payment, co-insurance, or deductible. Congress included co-pay requirements in these programs, in part, to encourage market forces to serve as a check on health care costs, including the prices that pharmaceutical manufacturers can demand for their drugs.

The Anti-Kickback Statute prohibits pharmaceutical companies from offering or paying, directly or indirectly, any remuneration – which includes money or any other thing of value – to induce Medicare patients to purchase the companies’ drugs.

Officials say Novartis coordinated with three co-pay foundations to funnel money through the foundations to patients taking Novartis’ own drugs, As a result, the Novartis’ conduct was not ‘charitable,’ but rather functioned as a kickback scheme that undermined the structure of the Medicare program and illegally subsidized the high costs of Novartis’ drugs at the expense of American taxpayers.

Novartis used The Assistance Fund as a conduit to pay kickbacks to Medicare patients taking Gilenya, a Novartis drug for multiple sclerosis, and used the National Organization for Rare Disorders and Chronic Disease Fund as conduits to pay kickbacks to Medicare patients taking Afinitor, a Novartis drug for renal cell carcinoma and progressive neuroendocrine tumors of pancreatic origin.

In October 2012, Novartis learned from Express Scripts, which then was managing Novartis’ free drug program for Gilenya, that Novartis was providing free Gilenya to 364 patients who would become eligible for Medicare the following year.

Novartis and Express Scripts transitioned these patients to Medicare Part D so that, in the future, Novartis would obtain revenue from Medicare when the patients filled their prescriptions for Gilenya.

Knowing that these patients could not afford co-pays for Gilenya, Novartis developed a plan for it to cover their co-pays through The Assistance Fund, which operated a fund that, ostensibly, offered to cover co-pays for any MS patient who met its financial eligibility criteria, regardless of which MS drug the patient was taking.

Novartis entered into a five-year corporate integrity agreement as part of this settlement. Novartis will be required to implement measures, controls, and monitoring designed to promote independence from any patient assistance programs that it finances. In addition, Novartis agreed to implement risk assessment programs and to obtain compliance-related certifications from company executives and Board members.

To date, the Department of Justice has collected over $900 million from ten pharmaceutical companies (United Therapeutics, Pfizer, Actelion, Jazz, Lundbeck, Alexion, Astellas, Amgen, Sanofi, and Novartis) that allegedly used third-party foundations as kickback vehicles. The Department also has reached settlements with four foundations (Patient Access Network Foundation, Chronic Disease Fund, The Assistance Fund, and Patient Services, Inc.) that allegedly conspired or coordinated with these pharmaceutical companies.

68 year old Linda Nguyen of Union City, was sentenced to two years in prison for her role in a multi-million dollar mail fraud conspiracy involving California State Disability Indemnity (SDI) benefits. Nguyen pleaded guilty to the charge on July 17, 2019.

The SDI program is designed to provide partial wage replacement benefits to eligible California workers who are unable to work due to a non-work-related illness, injury, or pregnancy. To receive SDI benefits, a claimant must file a claim for benefits supported by a Physician/Practitioner Certification attesting to the claimant’s disability.

Nguyen admitted that from January 2013 until January 2019, she agreed with a licensed physician and others to commit mail fraud by defrauding California’s SDI program.

Specifically, Nguyen admitted she helped non-disabled persons prepare and submit fraudulent applications and certifications for SDI benefits. In exchange for her services, Nguyen charged the non-disabled SDI applicants a fee equal to 10% of the SDI benefits that they received. In addition, she paid the physician for each certification he completed for the fraudulent application.

Nguyen’s plea agreement contains four examples of individuals for whom she completed fraudulent applications.

The agreement further describes how Nguyen paid a physician to complete and sign the practitioner disability certifications even though the applicants were never treated by the physician. Nguyen acknowledged in the agreement that the total loss attributable to the fraudulent scheme in which she participated is estimated to be between $3,500,000 and $9,500,000.

A federal grand jury indicted Nguyen on January 29, 2019, charging her with one count of conspiracy to commit mail fraud, in violation of 18 U.S.C. § 1349, and one count of substantive mail fraud, in violation of 18 U.S.C. § 1341. Nguyen pleaded guilty to the conspiracy count and the substantive mail fraud count was dismissed at sentencing.

In addition to the prison term, Nguyen was ordered to serve a three year term of supervised release, to begin at the end of the prison term, and to pay restitution.

With the likelihood of workers’ compensation COVID-19 claims on the horizon, and with presumptions supporting them, opportunities for apportionment of permanent disability may be more important than ever in claims management.

Researchers who just published a new study, report that a person’s blood type may affect their risk for COVID-19, the disease caused by the new corona virus.

The findings appear on the website medRxiv, where health researchers publish studies before they undergo the peer review process required by journals.

Researchers used observational healthcare data on 1559 individuals tested for SARS-CoV-2 (682 COV+) with known blood type in the New York Presbyterian (NYP) hospital system to assess the association between ABO+Rh blood type and SARS-CoV-2 infection status, intubation, and death.

They found a higher proportion of blood group A and a lower proportion of blood group O among COV+ patients compared to COV-, though in both cases the result is significant only in Rh positive blood types.

The effect of blood type is not explained by risk factors they considered (age, sex, hypertension, diabetes mellitus, overweight status, and chronic cardiovascular and lung disorders).

In a meta-analysis of NYP data with previously-reported data from China, they found enrichment for A and B and depletion of O blood groups among COVID-19 patients compared to the general population. They also found new evidence of associations between B, AB, and Rh blood groups and COVID-19 and further evidence of recently-discovered associations between A and O blood groups and COVID-19.

The China study was limited because of its small size and it didn’t offer an explanation for its findings, Gao Yingdai, a researcher from the State Key Laboratory of Experimental Hematology in Tianjin, told the South China Morning Post.

The finding that blood type may affect COVID-19 risk could be important for healthcare workers treating COVID-19 patients, because those with A blood types” “might need particularly strengthened personal protection to reduce the chance of infection.”

Also, people with A blood types might require “more vigilant surveillance and aggressive treatment,” and identifying a person’s blood type as a routine part of treating COVID-19 and other coronavirus infections might be helpful, according to the researchers, Newsweek reported.