Biotech Executive Charged in COVID-19 Test Fraud Case

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As if the coronavirus pandemic wasn’t bad enough as it is, fraudsters in the healthcare industry are manipulating it to further their wealth. The ongoing public health crisis has spawned a rash of fraudulent schemes, making COVID-19 fraud investigations a top priority for government agencies determined to root out fraud and corruption being committed against the U.S. healthcare system.

COVID-19 Testing Scam Exposed

A Silicon Valley medical technology company executive has been arrested and faces possible prison time for his alleged role in the first COVID-19-related criminal securities fraud case brought by the Department of Justice (DOJ).

Mark Schena, the president of Arrayit Corporation, has been charged in a complaint that alleges his participation in schemes that involved the submission of over $69 million in false and fraudulent claims for allergy and coronavirus tests that were medically unnecessary and/or not provided as represented. Schena is accused of misleading investors, manipulating the company’s stock price, and conspiring to commit healthcare fraud. He is charged with one count of securities fraud and one count of conspiracy to commit healthcare fraud.

According to the affidavit in support of the criminal complaint, Schena touted that Arrayit is the “only laboratory in the world that offers” revolutionary “microarray technology” that allows it to test for allergies and the coronavirus with the same finger-stick test kit. That supposed news led to the company’s stock price more than doubling in mid-March, even as the stock market was crashing.

As he was marketing the coronavirus test, Schena allegedly instructed clinics and patient recruiters to bundle Arrayit’s much more expensive allergy test with its COVID-19 test, regardless of whether it was medically necessary, furthering a pre-existing scheme, prosecutors said.

Schena’s Scheming Started 2 Years Ago

According to accusations, beginning in 2018 and through February 2020, Schena paid illegal kickbacks and bribes to doctors and recruiters to run Arrayit’s allergy screening test for 120 allergens — ranging from food allergens to stinging insects — on every patient, regardless of medical necessity. 

Schena and his co-conspirators allegedly made numerous misrepresentations to potential investors about Arrayit’s allergy test sales, the condition of the company’s finances, and its future prospects. They are also accused of issuing press releases and tweeting about partnerships with Fortune 500 companies, government agencies, and public institutions, without disclosing that such partnerships either did not exist or were of minimal value.

COVID-19 Crisis Escalates 

In March 2020, as the coronavirus pandemic began to intensify, Schena and others made false claims regarding Arrayit’s ability to provide fast, accurate, reliable, and cheap COVID-19 tests. They asserted the tests were in compliance with state and federal regulations and made numerous misrepresentations to potential investors about the coronavirus tests and Arrayit’s future prospects for COVID-19 testing.  

Schena claimed Arrayit had developed an accurate, cheap coronavirus test based “on advanced Silicon Valley technology and fingerstick blood collection.” The self-proclaimed “father of microarray technology” boasted that developing a COVID-19 test was easy. He stated that the switch from testing for allergies to testing for coronavirus was “like a pastry chef” who switches from selling “strawberry pies” to selling “rhubarb and strawberry pies.”

Mounting Deceit

According to the criminal complaint unsealed last month, Schena began promoting a COVID-19 test in early March that could be bundled with the company’s existing allergy test. In reality, Arrayit had not developed, produced, or validated a coronavirus test at that time. 

After the company developed a purported test, Schena and others promoted the test by falsely representing that government agencies and prominent scientists endorsed their approach of dual coronavirus and allergen testing. Arrayit’s marketing materials suggested that prominent public figures, such as Dr. Anthony S. Fauci, Director of Allergy and Infectious Disease and White House Coronavirus Coordinator Dr. Deborah Birx, were emphasizing the importance of a finger stick blood test for COVID-19 so not to confuse allergy symptoms with those of COVID-19.

As the company’s stock price soared in mid-March, Schena and his co-conspirators added to the misrepresentation by neglecting to divulge that there were questions about the accuracy of Arrayit’s COVID-19 test and the validity of its data.

On April 13, the SEC temporarily suspended trading of Arrayit stock because of questions regarding the accuracy and adequacy of publicly available information regarding the company’s financial condition and COVID-19 blood test. Days later, the Food and Drug Administration (FDA) informed Arrayit that its COVID-19 test did not meet the performance standards for emergency use authorization, yet Schena never disclosed the news to investors or customers.

“This defendant allegedly defrauded Medicare through illegal kickbacks and bribes, and then turned to exploiting the pandemic by fraudulently promoting an unproven COVID-19 test to the market,” Assistant U.S. Attorney General Brian Benczkowski, who heads the Justice Department’s Criminal Division, said in a statement.

Multimillion-Dollar Hoax Exposed

Billing data submitted by Arrayit and medical clinics that used the Arrayit test showed that from 2018 to the present, Arrayit submitted or caused the submission of over $5.9 million in claims to Medicare and over $63 million in claims to private insurance plans. Claims that were procured by the payment of kickbacks and bribes, medically unnecessary, and/or not provided as represented. Nonetheless, submission of the fraudulent claims resulted in Medicare paying $290,000 and private insurance plans paying more than $2 million to Arrayit and other medical providers ordering the Arrayit test.

If Schena is convicted, the securities fraud charge would carry a sentence of up to 20 years in prison and the health fraud conspiracy count would carry a sentence of up to 10 years.

FB Group: Women of Color Medical Coders

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Americans would get two checks under Treasury Department proposal

The payments would come in two separate checks, one arriving in April and another in May.

March 18, 2020, 11:33 AM CDT / Updated March 18, 2020, 1:29 PM CDT

By Josh Lederman and Dareh Gregorian

The Treasury Department will be asking Congress for $500 billion in direct payouts for taxpayers as part of a $1 trillion stimulus package to combat the economic effects of the coronavirus pandemic, according to a proposal obtained by NBC News.

The two rounds of direct payments to taxpayers, each a total of $250 billion, would be sent on April 6 and then the second round would be sent on May 18, according to the proposal. They would be tiered payments, with the amounts based on income level and family size, the proposal says. Both payments would be for the same amount.

President Donald Trump was asked about the proposal at a coronavirus briefing at the White House on Wednesday, and said, “I don’t want to get in that right now” because there are “different numbers” being discussed. But, he added, “we want to go big.”

Full coverage of the coronavirus outbreak

The Treasury is also asking for $50 billion for the airline industry, a small business interruption loan program of $300 billion, and $150 billion for other distressed sectors, the proposal said.

Trump had initially favored a payroll tax cut to bring relief to Americans struggling financially, but a number of lawmakers across party lines have been pushing for direct payments to Americans.

The White House first floated its support for sending checks directly to Americans during a news conference Tuesday. Treasury Secretary Steven Mnuchin said Trump wanted Americans to get relief as soon as possible.

Telehealth Coverage Expanded for Medicare Patients

The government is relaxing guidelines to ensure seniors get the healthcare they need during this national emergency.

A sweeping expansion of telehealth coverage for Medicare beneficiaries is being implemented to aid in the healthcare needs of those with the coronavirus, or COVID-19. The Centers for Medicare & Medicaid Services (CMS) announced in a March 17, 2020, press release that it will make a temporary change in its reimbursement policy for telehealth services. For dates of service (DOS) on or after March 6, 2020, CMS will reimburse physicians providing telehealth services to Medicare patients across the country, with fewer restrictions.

What Does the New Telehealth Policy Mean?

For an indefinite period of time, CMS will be removing all restrictions surrounding telehealth coverage for Medicare beneficiaries. This means that, for the time being, telehealth coverage will be reimbursed for patients who require telehealth services from within their own home. Patients may also communicate with providers with a more expansive range of communication methods, including the use of their smart phone for face-to-face interaction.

Telehealth services covered under this new waiver will allow for healthcare workers other than physicians to provide telehealth services to patients. Some of these additional healthcare providers include nurse practitioners, clinical psychologists, and licensed clinical social workers. The type of visit a patient may receive through telecommunication with their provider include, but are not limited to:

  • Common office visits
  • Mental health counseling
  • Preventative health screenings

Why the Change to Expand Coverage?

The implementation of this new waiver is to minimize any and all outside travel for a population of Medicare patients who are at higher risk of developing a serious illness from COVID-19. These new measures will also reduce some of the burden on hospitals, physicians, advanced practice providers, and other essential hospital staff. Telehealth services will be reimbursed at the same rate as in-person services under the Medicare Physician Fee Schedule.

Copay and Deductibles May be Waived

Following the CMS announcement, the Office of Inspector General released a policy statementregarding practitioners who choose to reduce or waive amounts owed by Medicare patients. Specifically, the federal agency will be providing “flexibility” for providers who choose to waive or reduce cost-sharing amounts, such as co-pays and deductibles, for visits paid for by federal healthcare programs.

Under normal circumstances, these practices could implicate a variety of exclusion laws related to kickbacks. However, during the COVID-19 outbreak and until further notice, clinicians face no legal repercussions in forgiving patients for cost-sharing amounts.

What About Medicaid?

CMS has recently released a document explaining policy options for Medicaid providers utilizing telehealth services. Specifically, Medicaid provides an overview of coverage and the facilitation of care via telehealth technology. You can find more information surrounding this Medicaid policy, in addition to a sample state plan, on the Medicaid website.

Department of Health and Human Services Targeted in Cyberattack

Posted By HIPAA Journal on Mar 17, 2020

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The U.S. Department of Health and Human Services (HHS) has been targeted by cybercriminals in what appears to be an attempt to overwhelm its website with millions of hits. According to a statement issued by HHS spokesperson, Caitlin B. Oakley, the HHS detected “a significant increase in activity on HHS cyber infrastructure” in what appears to have been an attempted Distributed Denial of Service (DDoS) attack.

The individuals responsible for the attack were unsuccessful thanks to additional protections put in place to mitigate DDoS attacks as part of HHS preparation and response to the COVID-19 pandemic. “HHS has an IT infrastructure with risk-based security controls continuously monitored in order to detect and address cybersecurity threats and vulnerabilities,” explained Oakley.

No data breach was experienced and the HHS and federal networks are continuing to function normally. Federal cybersecurity professionals are continuing to monitor HHS computer networks and will take appropriate actions to protect those networks and mitigate any further attacks should they occur. The federal government is investigating the attack and at this stage it is unclear who was responsible.

“We have extremely strong barriers, we had no penetration into our networks, no degradation of the functioning of our networks, we had no limitation on the ability or capacity of our people to telework, we’ve taken very strong defensive actions,” said HHS Secretary, Alex Azar.

The White House National Security Council (NSC) sent a tweet on Sunday warning about a disinformation campaign which suggests President Trump is about to order a national quarantine and that the country will be placed on lockdown, as has been the case in Italy and Spain. The NSC tweet explained that these text message rumors are fake. It is unclear if the attempted DDoS attack and text message campaign are related.

There are also several phishing campaigns being conducted that are using fear about SARS-CoV-2 and COVID-19 to spread malware and obtain sensitive information. The malicious email campaigns are likely to increase as the pandemic develops. If you receive any email communication related to SARS-Cov-2 and COVID-19, verify the validity of the message before taking any actions.

For up to date information and guidance on SARS-Cov-2 and COVID-19, visit the Centers for Disease Control and Prevention (CDC) website – CDC.gov.

Illinois Public Health Network Suffers Ransomware Attack

Last week, cybercriminals launched a cyberattack on the Champaign-Urbana Public Health District in Illinois and deployed Netwalker (MailTo) ransomware. The attack disabled the public health district’s website on the morning of March 10, 2020. The incident was investigated and was confirmed as a ransomware attack within a couple of hours.

Employees were able to continue to access critical systems during the website outage. No electronic medical records or other sensitive data have been compromised. Medical records were migrated to the cloud 6 months previously. The Champaign-Urbana Public Health District has since been restored.

Trump lifts restrictions on telehealth services for seniors in hopes of limiting coronavirus spread

by LEV FACHER @levfacher

MARCH 17, 2020

WASHINGTON — The Trump administration on Tuesday announced an unprecedented expansion of telehealth services for seniors, an effort to prevent healthy and sick Americans alike from visiting doctor’s offices in person and risk spreading or catching the novel coronavirus.

“Medicare patients can now visit any doctor by phone or videoconference at no additional cost, including with commonly used services like FaceTime and Skype,” Trump said during a White House press briefing. “A historic breakthrough — this has not been done before.”

Medicare, the federal health insurer that provides care to individuals 65 or older and others with disabilities or long-term care needs, covers roughly 62 million Americans. The coronavirus and Covid-19, the respiratory disease it causes, often results in particularly severe symptoms for seniors and those with preexisting health conditions like heart or lung disease.

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The action, officials said, eliminates the needs for seniors who require checkups or doctor visits unrelated to potential coronavirus infections to travel to in-person clinics and expose themselves to potential infection. Telehealth benefits had previously been restricted to seniors living in rural areas who had already sought care through a particular provider.

“Medicare beneficiaries across the nation, no matter where they live, will now be able to receive a wide range of services via telehealth without ever having to leave home,” said Seema Verma, the administrator of the Centers for Medicare and Medicaid Services. “And these services can also be provided in a variety of settings, including nursing homes, hospital outpatient departments, and more.”

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CMS, Verma said, would exercise “enforcement discretion when it comes to collecting copays, so that costs won’t be a barrier.”

Trump urged seniors to use telehealth as much as possible in an effort to slow the virus’ spread and to maintain hospital capacity — presumably by shifting in-person visits to doctor’s offices and hospitals increasingly inundated by coronavirus cases to remote visits conducted by phone or various video chat platforms.

The administration’s action effectively waives many existing restrictions on telehealth. Verma and Trump also stressed that the federal government would stop enforcing numerous elements of HIPAA, the health privacy law that, until now, heavily regulated providers seeking to deliver care remotely. In a statement, health secretary Alex Azar said providers could offer telehealth benefits to seniors “at a lower cost than traditional services.”Support STAT: If you value our coronavirus coverage, please consider making a one-time contribution to support our journalism.

The move comes after Trump signed a new law authorizing over $8 billion in new spending to combat the pandemic, including $500 million dedicated to helping clinicians expand telehealth services.

“In addition, states have the authority to cover telehealth services for their medical patients, Trump said. “And by doing this, the patient is not seeing the doctor per se, but they’re seeing the doctor, so there’s no getting close.”

The rules of video conferencing at home

By Kathryn Vasel, CNN Business Updated 12:17 PM ET, Mon March 16, 2020

Many workers are taking business meetings from their living rooms or kitchens these daysMORE FROM SUCCESS

How to work from home without losing your sanity

The rules of video conferencing at home

How to help your favorite small businesses survive the coronavirus crisisWith a growing number of companies asking employees to work from home due tocoronavirus,video conferencing hasallowed workers to continue having meetings. It also satisfies the social interaction many workers start to crave when they are working from home. But it can feel a little awkward letting people get a glimpse into our homes.Here’s what you need to know about remote video conferencing:

Dress casually, but appropriately

Follow your company’s culture when it comes to your attire for video calls.Some workers will be expected to keep the same attire they wear in the office, while for many others, it’s acceptable to dress more comfortably than they usually do at work. But comfortable doesn’t mean pajamas (at least not on top).”Tailor your appearance to the person you are working or dealing with,” recommended Jacqueline Whitmore, business etiquette expert and founder of The Protocol School of Palm Beach.But don’t get too wrapped up in your appearance.“I think people are more forgiving around these times of desperate measures,” said Whitmore. “The etiquette might not be as stringent.”

Get over your fear

Video calls work best when everyone gets on.”We are all in this socially awkward situation together,” said Peter Arvai, co-founder and CEO of presentation software company Prezi.And if some employees are in the office, everyone should still call in separately on their own device with a camera so you can see everyone clearly.”You want a good view of every participant,” said Arvai. “You don’t want to see a few people with their mini heads, that doesn’t work.”

Don’t sweat your background too much

If you have space in your home for a home office, that certainly makes it a lot easier to find a place to join a video call.But for people living in smaller dwellings, the home office could be the kitchen table, sofa or the bedroom — and that’s ok.Look for a background that is not distracting and put away any personal items that might be embarrassing or you want to keep private.And don’t worry about any sports memorabilia, vacation photos or movie posters hanging on the wall. “Use those things to establish the human connections,” said Arvai.However, if you are meeting with a new or potential client, take the time to look more put together, Whitmore said. “If you need to make a first impression, don’t do it in your bedroom in your bed surrounded by your covers.”

Find the light

Light is your friend when it comes to looking good and getting the most out of a video call.”What matters the most is to be able to see the facial expressions,” said Arvai. “If you can, sit by the window to have the light on your face, that creates a much better experience for others.”

Make introductions

Make sure meeting participants introduce themselves if everyone doesn’t know one another, advised Aruna Ravichandran, vice president and chief marketing officer of Cisco’s Webex Collaboration business.”Remote work is all about personalization and getting people comfortable to be able to have a conversation,” she said.

Limit your distractions

You know how annoying it is when someone is constantly looking at their phone or typing on their laptop during in-person meetings? It’s just as distracting in video meetings.”It can be disrespectful to other folks when you are constantly multitasking,” said Ravichandran.Turn off any notifications and any other programs that might tempt you to do something else during the meeting.”You want to keep some level of decorum when working from home,” said Whitmore. And remember: The mute button is your friend. If you aren’t talking, be on mute. No one wants to hear you munching on your mid-morning snack.Just be sure to give people a few seconds to unmute themselves to respond to a question or chime in.The meeting facilitator should give a reminder at the top of the meeting for people to mute to help avoid interruptions throughout the meeting.

Treasury pushes tax payment deadline back 90 days due to coronavirus

Washington (CNN)Individuals and businesses will have an extra 90 days to pay the IRS if they owe additional income tax for 2019, Treasury Secretary Steven Mnuchin said Tuesday.

Normally, taxpayers owe the amount due by April 15. But as part of the government’s response to the coronavirus, individual and small business filers will be able to defer payments of up to $1 million and corporations can defer up to $10 million — without incurring interest or penalties.

But taxpayers should still file their federal returns by April 15, Mnuchin said.

“We encourage those Americans who can file their taxes, to continue to file their taxes on April 15 because for many Americans you will get tax refunds. We don’t want you to lose out on those tax refunds,” Mnuchin said.

Taxpayers can still request a six-month extension to file returns, like they could in any other year.

The new deadline announced Tuesday applies to federal tax income payments only. It’s up to states to set their own deadlines.

Some states are making changes due to the coronavirus. In California, individuals will have until June 15 to both file and pay their state taxes.