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Hackers and Anaphylactoid Reactions Tarnish Vaccine Launch

The European Medicines Agency (EMA) reports that the agency has been subject to a cyber attack and that some documents relating to the regulatory submission for Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2, which has been stored on an EMA server, had been unlawfully accessed, BioNTech revealed in a statement published on its website.

The German biotechnology company, previously best-known for its work pioneering cancer immunotherapy research, stressed that “no BioNTech or Pfizer systems” were accessed during the breach, suggesting that it was the European Union regulator whose security failed.

They added that they were “unaware” of any of their study participants being identified as a result of the breach and that they are awaiting “further information about EMA’s investigation and will respond appropriately and in accordance with EU law.”

“Our focus remains steadfast on working in close partnership with governments and regulators to bring our COVID-19 vaccine to people around the globe as safely and as efficiently as possible to help bring an end to this devastating pandemic,” they concluded.

The British National Cyber Security Centre (NCSC) has indicated that the hack should not impact the BioNTech/Pfizer vaccine’s rapid and at-times troubled rollout in the United Kingdom.

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised that the coronavirus prophylactic should not be administered to people with a “history of a significant reaction” to medicines, foods, or vaccines, after two National Health Service (NHS) workers showed symptoms of an “anaphylactoid reaction” shortly after being injected.

The regulator now advised that “resuscitation facilities” should be present at all vaccination sites, and vaccinations not carried out if they are now available.

On the hacks, the NCSC said that it was “working with international partners to understand the impact of this incident affecting the EU’s medicine regulator, but there is currently no evidence to suggest that the UK’s medicine regulator has been affected.”

According to the BBC, it is “not clear” whether or not cyber-attackers also hacked the EMA’s documents on the Moderna vaccine at present.

China, Iran, and Russia have all been accused of using hackers against coronavirus vaccine research by Western governments.

DIR, DWC Publish IMR 2019 Annual Review Progress Report

The Department of Industrial Relations (DIR) and its Division of Workers’ Compensation (DWC) posted a progress report on the Department’s Independent Medical Review (IMR) program.

IMR is the medical dispute resolution process for the state’s workers’ compensation system that resolves disputes about the medical treatment of injured workers. The report describes IMR program activity in 2019, the seventh year since the program was implemented.

The organization administering the program, Maximus Federal Services, Inc., received over 222,000 IMR applications, and issued almost 164,000 Final Determination Letters, each addressing one or more medical necessity disputes.

Some highlights of the report:

— The monthly average length of time to issue an IMR determination after receipt of all medical records ranged from 7 to 8 days throughout 2019.
— An average of 13,600 IMR decisions were issued each month. Overall there was a 12% decrease from 2018.
— 93.5% of all unique IMR applications filings were deemed eligible for review.
10.4% of the utilization review (UR) decisions that denied treatment requests made by physicians treating injured workers were overturned. This rate of overturn is similar to the previous year (10.3%).
— As in previous years, substantially similar rates of overturned cases occurred in all geographic regions in which injured workers reside.
— Treatment request denials were overturned at a rate of 10.4%, with specialist consultations, office visits and mental health services overturned most often.
— Pharmaceuticals accounted for 36.7% of treatment requests sent for IMR with opioids comprising nearly one of every three pharmaceutical requests.
— Guidelines contained in the Medical Treatment Utilization Schedule continue to be the primary resource for the determination of medical necessity.

The progress report is posted on the DIR website.

Former Ventura Counnty Firefighter Guilty of $148K Comp Fraud

34 year old Perry Adam Lieber, who lives in Santa Barbara and who was a former Ventura County firefighter, was charged earlier this year with three felonies in a case involving workers’ compensation fraud.

Lieber allegedly made material misrepresentations about the nature and extent of an industrial injury as well as his true physical abilities, the DA’s office said. Prosecutors also say he misrepresented his income while getting disability pay and lied under oath during a deposition.

Lieber, ultimately pled guilty this month to felony workers’ compensation fraud under Insurance Code section 1871.4(a), admitting a special allegation that the theft totaled more than $100,000 in losses to the victims.

During his guilty plea, Lieber admitted making false and material misrepresentations for the purpose of obtaining disability benefits to which he was not entitled during his workers’ compensation claim.

Victim agencies York Risk Services and the County of Ventura are alleged to have sustained losses of approximately $148,177.

Chief Mark Lorenzen of the Ventura County Fire Department said Lieber resigned from the agency in early March.

According to a report in the Ventura County Star at the time of his arrest, the Chief said the department was not surprised by the charges the DA’s office has brought against Mr. Lieber. “We were aware of a number of irregularities during the last portion of his career. We brought those to the attention of the county risk management unit.”

The maximum penalty for a violation of Insurance Code 1871.4(a) is five years in jail, as well as a fine of up to double the amount of fraud, or approximately $296,354.

At the time this case was filed, the Ventura County District Attorney’s Office Workers’ Compensation Fraud Unit obtained a temporary restraining order seizing Lieber’s bank accounts and other assets in connection with the fraud investigation.

As a condition of Lieber’s plea, a portion of these assets will be liquidated to pay victim restitution and criminal fines.

Lieber is scheduled to be sentenced on January 6, 2021, at 9:00 a.m. in courtroom 12 of the Ventura County Superior Court.

Simi Valley Contractor Convicted for $176K Premium Fraud

On December 8, 53 year old David Burgmeier, who lives in Simi Valley California, pleaded guilty to four counts of felony insurance fraud and four counts of felony unemployment insurance fraud.

At the time of his pleas, Burgmeier paid $45,000 in partial restitution owed to the victims in this case, the State Compensation Insurance Fund (State Fund) and the State of California Unemployment and Disability Insurance Tax Program (EDD).

According to CSLB records, Burgmeier has been a licensed general building contractor since 1998. From March 2008 through March 2016, Burgmeier owned and operated Burgmeier Construction in Simi Valley.

During that time, Burgmeier misrepresented the number of his employees and the total amount of payroll to the victims in this case. His fraud resulted in the underpayment of insurance premiums totaling $176,265 to State Fund, and an underpayment of taxes totaling $39,608 to EDD. <br /

Burgmeier will be sentenced on January 7, 2021, at 9:00 a.m. in courtroom 47 of the Ventura County Superior Court.

Burgmeier faces a maximum sentence term of 10 years 8 months in prison.

His state contractors license expired on May 31, 2018 and he is no longer licensed in California.

New CMS Final Rule “Modernizes” Anti-Kickback” Law Implementation

On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to modernize and clarify the regulations that interpret the Medicare physician self-referral law (often called the “Stark Law”), which has not been significantly updated since it was enacted in 1989. .

Under the Stark Law, a physician is prohibited from making referrals to an entity for healthcare services if the physician has a financial relationship with the entity. The regulations were intended to protect patients in a health care system that reimbursed providers on a fee-for-service basis. In this type of system, there is a motivation to provide more services.

The new final rule supports the CMS “Patients over Paperwork” initiative by reducing the unnecessary regulatory burdens on physicians and other healthcare providers while reinforcing the Stark Law’s goal of protecting patients from unnecessary services and being steered to less convenient, lower quality, or more expensive services because of a physician’s financial self-interest.

Through the Patients over Paperwork initiative, the final rule opens additional avenues for physicians and other healthcare providers to coordinate the care of the patients they serve – allowing providers across different healthcare settings to work together to ensure patients receive the highest quality of care.

In addition, as part of the Regulatory Sprint to Coordinated Care, CMS worked closely with the Department of Health and Human Services Office of Inspector General in finalizing policies that advance the transition to a value-based healthcare delivery and payment system that improves the coordination of care among physicians and other healthcare providers in both the federal and commercial sectors.

Healthcare Leadership Council President Mary Grealy said, “This should be recognized as one of the most important health policy achievements of recent years. We are moving toward an era in healthcare that recognizes the importance of care coordination and fully integrated care involving primary care providers, specialists, hospitals, pharmacies, drug and device manufacturers and more.”

Grealy continued, “These laws, as written, discouraged innovative patient-focused multi-sector collaborations at a time in which we should be enthusiastically encouraging them. What these new rules recognize is that we can protect patients from fraud and abuse while still allowing the healthcare system to evolve in a way that benefits patients and achieves greater cost-efficiency.

It remains to be seen if regulators in California will follow this thinking in terms of regulating those involved in workers’ compensation medical delivery systems

Feds Approve Telemedicine Opiate Prescribing – For Now

In the COVID-19 era, under relaxed federal emergency orders, licensed clinicians have been able to prescribe opioid analgesics for their patients even if they’ve only ever seen the patient via telehealth, rather than in person.

The Ryan Haight Online Pharmacy Consumer Protection Act, passed in 2008, included a prohibition on writing prescriptions for controlled substances such as opioids by means of the internet unless the clinician first conducted an in-person exam. It came with a number of exceptions and carve-outs, one of which is for public health emergencies such as the one declared by HHS Secretary Alex Azar, MD, on Jan. 31. It effectively put the Ryan Haight Act provision on hold for the duration of the emergency.

The Drug Enforcement Agency issued an exception allowing prescribing of controlled substances via telemedicine without a prior in-person visit during the pandemic, though it specifies that telephone-only communications are not part of that exception.

But what happens when the current COVID emergency order issued by the Department of Health and Human Services (HHS) expires? Palliative care doctors who have learned how to manage patients remotely via telemedicine may have to return to old ways — including a requirement that they see a patient in person before prescribing opioids.

CMS has indicated that it will revisit guidelines around telehealth services generally at the time when the emergency order is phased out. However it is not known if it address the prescribing situation.

This question plays out in the context of the other, ongoing national epidemic of prescription opioid overdoses, with federal agencies trying to curb excessive opioid prescribing.

Because every state is different, both for opioids and telehealth, providers need to take a close look at existing state law.

Attorney Sarah Churchill Llamas, chair of the healthcare industry group at the law firm Winstead PC in Austin said “At the end of the day, even if doctors do everything they’re supposed to, they could still get reviewed by their state medical board. Now that you’re overlaying telemedicine on top of opioid prescribing, I could see where a physician might say: ‘I just don’t feel comfortable going out on a limb with this.”

“My advice, do what’s best for your patients’ care, but plan for the future. You have to know that the relaxation of regulations due to the emergency orders is going to end, and that may be tough for your patients.”

Constitutionality of California Employer Arbitration Ban Argued

Last year, Governor Gavin Newsom signed AB 51, which effectively outlawed mandatory arbitration agreements with employees – a new version of a bill that prior Governor Jerry Brown had vetoed repeatedly while he was in office.

The law allows workers to pursue damages and attorneys’ fees and open criminal cases against employers who discriminate and retaliate against them for declining arbitration contracts.

The analysis of the Senate Rules Committee demonstrated that the legislature was well aware that a bill prohibiting arbitration agreements could be challenged as being preempted by the Federal Arbitration Act (“FAA”).

As the bill’s author stated, “The Supreme Court has never ruled that the FAA applies in the absence of a valid agreement. AB 51 regulates employer behavior prior to an agreement being reached. Further, understanding the Courts’ hostile precedence toward policies that outright ban or invalidate arbitration agreements, AB 51 does neither. Both pre-dispute and post dispute agreements remain allowable and the bill takes no steps to invalidate any arbitration agreement that would otherwise be enforceable under the FAA. The steps help ensure this bill falls outside the purview of the FAA.”

Courthouse News reports that this past January, U.S. District Judge Kimberly Mueller blocked state officials from enforcing key provisions of the bill that regulate agreements governed by the Federal Arbitration Act. The Obama appointee agreed with a coalition of business groups led by the U.S. Chamber of Commerce that AB 51 unfairly regulated or singled out arbitration agreements in comparison to other contracts.

The ruling was appealed to the 9th Circuit Court of Appeals, and the matter was set for oral argument this December.

Arguing employers could retaliate against workers, a California Justice Department attorney told a Ninth Circuit panel Monday it should overturn a judge’s ruling that federal law preempts the state’s pro-worker bill barring arbitration requirements as conditions of employment.

Proponents of the bill say it protects workers in food service, hospitality and retail who are increasingly being forced to sign away their rights to sue in exchange for being hired.

The chamber argued the bill would unfairly expose California businesses to civil and criminal penalties and force them to both alter hiring practices and spend more on dispute resolution.

California Deputy Attorney General Chad Stegeman told the Ninth Circuit AB 51 was crafted to complement the Federal Arbitration Act – referred to during oral arguments as the FAA – and that it doesn’t undermine arbitration but rather targets employers’ “discriminatory intent” toward workers.

“It’s a matter of consent. An employer can’t fire an employee because of their refusal to arbitrate,” Stegeman said, adding Mueller’s ruling exposes workers to unfair contracts. “The court created a new substantive right to force arbitration. But there’s no such right derived from the FAA.”

Andrew Pincus of Mayer Brown, an attorney for the chamber, told the panel the Federal Arbitration Act clearly preempts state laws that block formation and enforcement of arbitration agreements.

Supreme Court precedent directly applies in situations described in AB 51 where workers must weigh the benefits of nonnegotiable employment contracts even if they don’t have the same bargaining power, Pincus said.

The panel took the matter under submission and did not indicate when it would rule.

“V-Day” – First Person Now Vaccinated for COVID

A retired British shop clerk received the first shot in the country’s Covid-19 vaccination program Tuesday, the start of an unprecedented global immunization effort intended to offer a route out of a pandemic that has killed 1.5 million.

The Associated Press reports that Margaret Keenan, who turns 91 next week, got the shot at 6:31 a.m. on what public health officials have dubbed “V-Day.” She was first in line at University Hospital Coventry, one of several hospitals around the country that are handling the initial phase of the United Kingdom’s program. As luck would have it, the second injection went to a man named William Shakespeare, an 81-year-old who hails from Warwickshire, the county where the bard was born.

The U.K. is the first Western country to start a mass vaccination program after British regulators last week authorized the use of a Covid-19 shot developed by U.S. drugmaker Pfizer and Germany’s BioNTech. U.S. and European Union regulators may approve the vaccine in the coming days or weeks, fueling a global immunization effort.

Britain’s program is likely to provide lessons for other countries as they prepare for the unprecedented task of vaccinating billions of people. U.K. health officials have been working for months to adapt a system geared toward vaccinating groups of people like school children and pregnant women into one that can rapidly reach much of the nation’s population.

Amid the fanfare that greeted Britain’s first shot, authorities warned that the vaccination campaign would take many months, meaning painful restrictions that have disrupted daily life and punished the economy are likely to continue until spring.

Other vaccines are also being reviewed by regulators around the world, including a collaboration between Oxford University and drugmaker AstraZeneca and one developed by U.S. biotechnology company Moderna.

Britain has received 800,000 doses of the Pfizer vaccine, enough to vaccinate 400,000 people. The first shots will go to people over 80 who are either hospitalized or already have outpatient appointments scheduled, along with nursing home workers and vaccination staff. Others will have to wait their turn.

Britain is the first country to deliver a broadly tested and independently reviewed vaccine to the general public. On Saturday, Russia began vaccinating thousands of doctors, teachers and others at dozens of centers in Moscow with its Sputnik V vaccine.

China has also begun giving its own domestically made shots to its citizens and selling them abroad. But those products are being viewed differently because neither countries’ vaccines have finished the late-stage trials scientists consider essential for proving that a vaccine is safe and effective.

Applicant Attorney Arrested For Adelante Interpreting Inc. Scam

Applicant attorney, Moses Luna, 73, of Newport Beach, was arrested on 20 felony counts of insurance fraud after allegedly billing 20 separate insurance companies for translation and interpreting services to collect over $310,000 in undeserved workers’ compensation fees.

An investigation by the Department of Insurance and the Orange County District Attorney’s Office found Luna, a workers’ compensation attorney, created Adelante Interpreting, Inc., a translation and interpreting company, and then fraudulently billed 20 separate insurance carriers for translation and interpreting services.

Luna exclusively referred his own workers’ compensation clients to Adelante Interpreters to fraudulently collect over $311,220 in workers’ compensation fees.

The fees Luna received were for translation and interpreting services rendered to workers’ compensation claimants during depositions and medical appointments. Insurance companies paid the fees, due to Luna’s referrals, since the services were necessary for processing the claims.

Luna failed to disclose his financial interest in the company, as required by law, and used his daughter’s name, Deborah Luna, on corporate paperwork to hide his ownership of the company.

Although his daughter’s name was used for the paperwork, Luna controlled all aspects of Adelante Interpreters including, but not limited to: administrative protocols, employee protocols, independent contractor protocols, as well as billing and collection protocols.

The victim insurance companies include: ACM, AIG, Amtrust, BHHC, CompWest, Employers, ESIS, Farmers, Hartford, ICW, Liberty Mutual, Markel, Matrix, Midwest, Sedgwick, SCIF, Sentry, Travelers, York and Zurich.

Luna is scheduled to return to court on January 19, 2021. This case is being prosecuted by the Orange County District Attorney’s Office.

OSHA Announces $2,851,533 in Coronavirus Violations

Cal/OSHA’s emergency regulations requiring employers to protect workers from hazards related to COVID-19 are now in effect, following their approval by the Office of Administrative Law. The emergency standards apply to most workers in California

These are strong but achievable standards to protect workers. They also clarify what employers have to do to prevent workplace exposure to COVID-19 and stop outbreaks,” said Cal/OSHA Chief Doug Parker.

Some Non-California employers are required to meet Federal OSHA standards. OSHA has markedly stepped up its enforcement of safety measures related to coronavirus.

Since the start of the coronavirus pandemic through Nov. 5, 2020, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has issued 203 citations arising from inspections for violations relating to coronavirus, resulting in proposed penalties totaling $2,851,533.

OSHA inspections have resulted in the agency citing employers for violations, including failures to:

— Implement a written respiratory protection program;
— Provide a medical evaluation, respirator fit test, training on the proper use of a respirator and personal protective equipment;
Report an injury, illness or fatality;
— Record an injury or illness on OSHA recordkeeping forms; and
— Comply with the General Duty Clause of the Occupational Safety and Health Act of 1970

OSHA has already announced citations relating to the coronavirus arising out of 178 inspections, which can be found at dol.gov/newsroom.

Eleven of the most recent citations, issued between Nov. 20 and Nov. 26 and made public Friday, have resulted in coronavirus-related fines totaling $101,207, according to the statement. All 11 employers cited are either health care facilities or senior care living facilities, with recent fines up to $25,061, according to data released by OSHA.

OSHA provides more information about individual citations at its Establishment Search website, which it updates periodically.