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HIPAA, Google, and Article III Standing, With a Nod to Kim Kardashian

Google Shidonna Raven Garden and Cook

Saad GulMichael Slipsky, Poyner Spruill LLP+ Follow 

In a ruling that could have broad ramifications for health data sharing, a federal judge has ruled that a patient complaining about a hospital sharing his health data without permission lacked standing because he suffered no loss.

The case arose out of University of Chicago Medical Center patient Matt Dinerstein’s concerns about the hospital’s arrangement with Google. The hospital and Google partnered to share thousands of de-identified patient records. At the heart of the initiative was a machine learning project using Google’s electronic medical records data. The objective was to improve healthcare outcomes, for instance reducing care complications.

In a suit filed last June, Dinerstein argued the arrangement violated HIPAA. The partners had not obtained consent to share data. Nor had they informed patients that they would be sharing their data.

A federal judge dismissed the suit last week. The court rejected Dinersteins arguments that his medical records had commercial value, and their appropriation was theft. Both the University of Chicago and Google argued that their data sharing practices were HIPAA compliant. And they contended that Dinerstein’s allegations of fraud and deceptive business practices were meritless since he had voluntarily shared his medical data.

The gist of the defendants’ argument was that Dinerstein offered no contractual or Common Law authority to support his contention that he had a legal interest in his personal health information (PHI). But even if he had, he could not show that their actions had diminished the value of any property interest. And finally, he had shown no pecuniary damages stemming from the alleged contractual breach.

Critics complained that the partnership enabled Google to access mammoth amounts of PHI without patient consent. The partners argued that the material was deidentified data. Critics countered that the ostensibly deidentified data contained physician notes and dates, thereby nullifying any deidentification. The issue implicated partnerships other than the one with University of Chicago. Google has similar arrangements with other partners.

It has consistently maintained that its partnerships adhere to HIPAA mandates. The sole objective was to improve healthcare. Even so, unease with the practice has prompted Congress to query if it is time to update HIPAA in an age of Big Data and corona.

The court ultimately determined that the defendants had the better argument on procedural grounds. Without monetary harm, breach of contract would not confer standing.

“The alleged invasion of Plaintiff’s privacy is an injury in fact that can support his claim of intrusion upon seclusion,” the court suggested. “Dinerstein seems to suggest that the statutes at issue here—HIPAA and the MPRA—also create a legal interest in his health information… [but] has cited no authority supporting the proposition that HIPAA or the MPRA creates a property interest in health data.”

The court stressed that Congress had not created a private right of action for HIPAA. Dinerstein could not sidestep this by pursuing it as a breach of contract claim.

The decision raises three interesting implications for the future

First, it ignores that personal data is bought and sold. A marketplace reflects value. And that is regular citizen PHI. Celebrities from Kim Kardashian to Prince have long dealt with insiders selling their PHI. UCLA paid $856,000 to resolve allegations that personnel sold Kardashian data. Other high profile individuals such as Britney Spears, George Clooney, Farrah Fawcett, Drew Barrymore, Arnold Schwarzenegger, Tom Hanks, and Leonardo DiCaprio have also had their PHI sold.

Second, the court’s reasoning that PHI’s lack of economic value translates to the absence of Article III standing means that HIPAA violators are accountable only to regulators.

Third, the decision went against a state court trend we have previously analyzed: the principle that HIPAA sets the standard of care for privacy. Like any other tort claim, deviation from this standard of care that results in a loss of privacy is a cognizable injury that gives rise to a claim.

Only time will tell if the decision is an outlier or a harbinger of future HIPAA or privacy holdings. If federal and state courts adhere to their current courses, the outcomes of privacy lawsuits will hinge on the forum rather than the facts or legal theories presented.

How are your medical records being shared? Do you know? How would you prefer your medical records to be shared? Do you doctors know? How can this impact the care they give you? How can a breach or sharing of your medical records impact your health outcomes?

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Dealing with disruptive physicians


Source: MGMA
Judith Holmes ESQ.
Leigh Olson

Effective practice administrators accomplish a great deal without blinking but many struggle with how to deal with disruptive physicians, a topic of conversation for at least 30 years, according to a Journal of the American Medical Association (JAMA) article. When disruptive physicians cause problems, everyone comes to the administrator expecting a perfect resolution to the problem. Here are four common situations that illustrate that point:

  • A young female physician says that a physician in the group made degrading, insulting comments to her and regularly calls her “Ms.” instead of “Doctor.”
  • A staff member threatens to quit because a physician has harassed her for months, telling inappropriate jokes, making suggestive sexual comments and touching her inappropriately.
  • A nurse practitioner reports that a physician has repeatedly yelled at her, thrown a chart at her and frequently berates her in front of patients.
  • A physician refuses to attend mandatory practice group meetings and argues with other physicians. She is chronically late, which leads to waiting room backups and angry patients.

The American Medical Association (AMA) defines disruptive behavior as personal conduct, whether verbal or physical, that negatively affects or that potentially may negatively affect patient care. This includes but is not limited to conduct that interferes with one’s ability to work with other members of the healthcare team. However, criticism that is offered in good faith with the aim of improving patient care should not be construed as disruptive behavior.

These situations all involve inappropriate, disruptive behavior as well as a power disparity, especially if the practice administrator works for the physician, which makes it difficult to resolve the problem. Even seasoned administrators find it difficult to resolve situations involving powerful, influential physicians whose behavior adversely affects the practice. These individuals are often intimidating and not accustomed to being questioned. They are rarely open to accepting criticism about their conduct and less receptive to requests for behavior modification. As a result, bad behavior might have been tolerated for years, which has caused low morale and high staff turnover.

Tolerating inappropriate behavior can increase the likelihood your practice will be sued or that a charge will be filed with the Equal Employment Opportunity Commission (EEOC). In 2015, the EEOC reported more than 89,000 claims had been filed against employers by employees for allegations of harassment, discrimination and retaliation.

Protecting the practice

If bad behavior goes unchecked, it can jeopardize the future of a practice. Here are some steps administrative leaders can take to protect their practices before disruptive physicians cause significant or irreparable damage to the practice:


Dr. Disruptive (Dr. D) just berated a staff member in front of a patient and several employees. This is the third instance of his uncontrolled anger in the past month. Two valued employees have now threatened to quit if they are the target of one more outburst. What should you do?

Ignoring complaints, which might be tempting, will likely lead to more bad behavior and potential legal liability. A head-in-the-sand approach is particularly damaging when a physician or staff member reports behavior to you and expects a response or some type of change. If there is no improvement in a physician’s behavior, you might lose good staff members and the culture of bad behavior will become more entrenched.

Your first step should be to assure your valued staff members that you take the complaint seriously, that you will investigate the concerns and, if appropriate, you will take steps to ensure remedial measures are taken to prevent recurrence of the conduct. Take comprehensive factual notes regarding the complaints or ask the employee to submit the complaint in writing. Offer to keep the complaint as confidential as possible, assure the employee that there will be no retaliation for reporting the incidents and request that the employee advise you immediately if he or she believes there have been retaliatory actions by Dr. D or anyone else.

Your second step is to determine the most effective way to confront Dr. D about his behavior. You can discuss the problem but this alone will likely not solve the problem, and the confrontation might have a lasting adverse effect on your relationship with the physician. Frequently disruptive physicians become defensive when confronted and believe they are not responsible for the outburst or other offensive conduct. Many times, a disruptive physician isn’t aware of the effect he or she has on colleagues and staff members, and might resent you for pointing out a personal fault he or she doesn’t want to recognize. If Dr. D is defensive or unaware of his effect on others, he will simply reject what you say and add you to his list of adversaries. You will have gained little and jeopardized your ability to communicate effectively with Dr. D in the future.


Once you recognize the necessity of confronting Dr. D about his disruptive behavior, seek assistance. If your group does not have an executive committee with an established procedure in place for addressing disruptive physicians, you will need to partner with at least one other influential physician in the group who shares your concerns and is willing to support your efforts to confront the issue and act as a liaison between Dr. D and the group. That individual should be able to be objective, so he or she should not be a personal friend of Dr. D and should not be an individual Dr. D perceives as an adversary.

Once the physician/liaison has been selected, convey the facts, discuss the likely outcome of failing to alleviate the problem and suggest ways the two of you can approach Dr. D to maximize the chance of a positive outcome. Although every situation is different and requires a unique approach, here are some suggestions for conducting a successful meeting:

  • Empower your physician/liaison to speak on behalf of the practice. When the meeting with Dr. D is scheduled, it should be clear that the liaison has the authority to speak on behalf of the practice.
  • Prepare an outline of points you want to cover. Stick to a script so you avoid getting pulled into an argument. Have copies of your code of conduct and any written policies and rules that apply to the situation.
  • Conduct the meeting in a private, comfortable, professional setting. Reduce the tension as much as possible to encourage a positive dialogue. Do everything possible to make this a problem-solving experience.
  • Explain the problem behavior to Dr. D in factual terms. Describe the sequence of events and discuss the effect Dr. D’s behavior had on staff and the potential adverse effects his actions had on his professional reputation and the reputation of the group.
  • Refrain from using emotional terms such as bad behavior, tirade or childish tantrum to describe the conduct. These terms might describe the conduct but can polarize the situation and make Dr. D more defensive.
  • Give Dr. D the opportunity to explain the situation in his own words. Chances are he will not take responsibility for his behavior or might blame staff incompetence for an outburst. He may attempt to change the subject and begin listing the ways the group is at fault for mistreating him. Don’t take the bait. Insist those grievances be taken up at a different time and remind Dr. D that the purpose of the meeting is to address his conduct on specific dates.
  • Ask for Dr. D’s input on how past situations could have been handled differently to avoid the incidents that gave rise to complaints. Make it clear that there is never a valid reason for treating staff members disrespectfully.
  • When discussing Dr. D’s conduct, consider whether the outbursts may be a result of a drug or alcohol problem or whether his conduct could be the result of mental illness, such as depression. If there is some indication that Dr. D’s conduct is a result of one of these issues, it might be appropriate to refrain from taking any action until you consult with the executive committee and act in accordance with your substance abuse policy.
  • Advise Dr. D that you will be drafting a performance improvement plan (PIP) that will require him to make immediate, permanent changes in his behavior. Make it clear that failure to comply with the terms may result in discipline, up to and including termination. The PIP should include objective, measurable and achievable goals designed to prevent disruptive behavior in the future.
  • Make it very clear to Dr. D that no retaliation of any kind will be tolerated. If you have a written retaliation policy, be prepared to give Dr. D a copy at the end of the meeting.
  • Carefully document what occurred and what was discussed during the meeting.
  • Follow through. If you put Dr. D on a PIP, monitor his behavior and respond quickly and appropriately if requirements are not met.

This type of approach is not appropriate for every situation. Some situations require immediate action. For example, if disruptive behavior involves threats, violence or sexual harassment, the practice must act promptly to remedy the problem.


If a group has tolerated disruptive behavior for years, you won’t change the culture overnight. However, you can implement policies and protocols that will help protect your practice in the long run. Those policies should be assembled in a physician handbook and include policies that:

  • Prohibit unlawful harassment that includes a clear statement that your group strictly prohibits sexual harassment as well as harassment on the basis of race, color, gender, religion, disability and all other categories protected by federal and state law. The policy should define harassment and give examples of unacceptable behavior.     
  • Prohibit discrimination on the basis of any protected category. This is helpful when addressing a situation in which a disruptive physician refuses to work with a colleague because of gender, religion, ethnicity, etc.
  • Define unacceptable behavior. This physician discipline policy should also include a step-by-step procedure the group will use to investigate complaints.
  • Prohibit retaliation against any employee to ensure that when staff members or physicians make complaints about a disruptive physician, they are protected from any retaliatory conduct.
  • Prohibit workplace violence that includes a description of prohibited conduct as well as a clear statement that violence or threats of violence must be reported.
  • Address the issue of impaired physicians that will be used to assess and address this very complex issue. The procedure might include a multistep plan for board intervention, mandatory leave and/or referral to an appropriate rehabilitation or mental health program. It should also include clear consequences for failure to rectify impairment issues within a reasonable time period.

Many practices take the time and effort to develop behavior standards but do not take the extra step to make the policies an integral part of their management and discipline strategies. Incorporate behavior standards into a comprehensive physician handbook. Once you have implemented behavior policies, be sure to train every physician on what those policies mean and how they will be enforced, and then apply those policies consistently. It is a time-consuming effort, but if the group is guided by the policies contained in your handbook, your practice management will get much easier.Coming in the August issue: Learn how to curb disruptive conduct, establish a code of conduct and use physician contract provisions to reward good behavior and discourage bad behavior. We will also examine conflict resolution techniques that will help you resolve personality disputes that lead to disruptive behavior.

How are patients impacted by these inappropriate behaviors? Have you ever seen these behaviors in your doctors? What should be done for patients?

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Judith Holmes

Judith HolmesESQ.

PrincipalMaster Series Seminars, LLC.Leigh Olson

Leigh Olson

PrincipalMaster Series Seminars, LLC.

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GlaxoSmithKline Most Heavily Fined Drug Company

Source: Pain News Network
By Pat Anson, PNN Editor

The pharmaceutical industry has long been criticized for engaging in illegal or unethical activities, such as fraud, kickbacks and price gouging. A new study published in JAMA shines a light on the scale of the problem, finding that Big Pharma paid over $30 billion in financial penalties for illegal activities in the United States.

Researchers looked at state and federal settlements from 2003 to 2016 and found that almost every large pharmaceutical company had paid a fine for illegal activity. The biggest transgressor was GlaxoSmithKline (GSK), which paid nearly $9.8 billion to settle 27 cases brought against it for bribery, corruption, improper marketing, pricing violations and selling adulterated drugs. In one settlement alone, GSK was fined $3 billion for encouraging doctors to prescribe its antidepressants to children.  

The fines paid by GSK were over three times higher than the amounts paid by Pfizer ($2.9 billion) and Johnson & Johnson ($2.6 billion) during the study period. Researchers say only four of the 26 drug companies they analyzed were not assessed a penalty.


  1. GlaxoSmithKline $9.8 billion
  2. Pfizer $2.9 billion
  3. Johnson & Johnson $2.6 billion
  4. Abbott Laboratories $2.5 billion
  5. Merck $2.1 billion
  6. Eli Lilly $1.8 billion
  7. Schering-Plough $1.6 billion
  8. Wyeth $1.6 billion
  9. Bristol Myers Squibb $1.4 billion
  10. Novartis $1.2 billion
Source: Pain News Network
Shidonna Raven Garden and Cook

“Among the large pharmaceutical companies included in this study, 85% had evidence of financial penalties for illegal activities. Given the scope and nature of the illegal activities involving financial penalties, physicians and regulators should exhibit vigilance over the activities of large pharmaceutical firms,” wrote lead author Denis Arnold, PhD, a professor of business ethics at Belk College of Business, University of North Caroline at Charlotte.

“Four firms were not found to have penalties for illegal activities during the sample period. This may indicate an ability for illegal activity to be undetected, although these firms may instead have effective ethics and compliance programs.”

Because the study period ended in 2016, it did not include any recent settlements with drug companies involving opioid litigation. Nor did it cover fines paid outside the U.S., such as the $490 million fine that GSK paid for bribing Chinese doctors to prescribe its medications.

“This has been a deeply disappointing matter for GSK,” chief executive Sir Andrew Witty said in a formal apology to the Chinese government in 2014.

Not much has changed at GSK over the years. This year the company agreed to pay $4.5 million in fines in Australia for marketing and price violations involving the pain relief gel Voltaren.  The British pharmaceutical giant was also recently fined $2.8 million by Romania for failing to supply the country with asthma medication.

Drug company executives rarely serve prison time for illegal activities and the large fines do not appear to be much of a deterrent against unethical behavior. The nearly $9.8 billion paid by GSK amounts to less than 2 percent of its total revenues during the study period. On average, GSK’s illegal activities went on for over seven years before the company stopped them, according to the JAMA study.

GSK did not respond to a request for comment for this story.    

Fraud Alert for Speaker Programs

In recent years, federal watchdogs have become increasingly concerned about the use of speaker fees, free meals, entertainment and other kickbacks paid by healthcare companies to promote their drugs and medical devices. In the last three years, companies paid nearly $2 billion to healthcare providers for speaker-related services.

In a special fraud alert released this week, the Office of Inspector General (OIG) for the Department of Health and Human Services warned against the practice, saying high-priced speaker programs “may be subject to increased scrutiny.” The OIG cited cases where speaker programs were held at wineries, stadiums and restaurants where expensive meals and alcohol were served at no charge to attendees.

“OIG is skeptical about the educational value of such programs. Our investigations have revealed that, often, HCPs (healthcare providers) receive generous compensation to speak at programs offered under circumstances that are not conducive to learning or to speak to audience members who have no legitimate reason to attend,” the report warns.

“Furthermore, studies have shown that HCPs who receive remuneration from a company are more likely to prescribe or order that company’s products. This remuneration to HCPs may skew their clinical decision making in favor of their own and the company’s financial interests, rather than the patient’s best interests.”

Why do you think these companies were fined? Do you take any medications from these companies? Why? Why not?

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FDA and NIH let clinical trial sponsors keep results secret and break the law


Source: Science Magazine
By Charles PillerJan. 13, 2020 , 11:00 AM

For 20 years, the U.S. government has urged companies, universities, and other institutions that conduct clinical trials to record their results in a federal database, so doctors and patients can see whether new treatments are safe and effective. Few trial sponsors have consistently done so, even after a 2007 law made posting mandatory for many trials registered in the database. In 2017, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) tried again, enacting a long-awaited “final rule” to clarify the law’s expectations and penalties for failing to disclose trial results. The rule took full effect 2 years ago, on 18 January 2018, giving trial sponsors ample time to comply. But a Science investigation shows that many still ignore the requirement, while federal officials do little or nothing to enforce the law.

Science examined more than 4700 trials whose results should have been posted on the NIH website under the 2017 rule. Reporting rates by most large pharmaceutical companies and some universities have improved sharply, but performance by many other trial sponsors—including, ironically, NIH itself—was lackluster. Those sponsors, typically either the institution conducting a trial or its funder, must deposit results and other data within 1 year of completing a trial. But of 184 sponsor organizations with at least five trials due as of 25 September 2019, 30 companies, universities, or medical centers never met a single deadline. As of that date, those habitual violators had failed to report any results for 67% of their trials and averaged 268 days late for those and all trials that missed their deadlines. They included such eminent institutions as the Harvard University–affiliated Boston Children’s Hospital, the University of Minnesota, and Baylor College of Medicine—all among the top 50 recipients of NIH grants in 2019.

The violations cover trials in virtually all fields of medicine, and the missing or late results offer potentially vital information for the most desperate patients. For example, in one long-overdue trial, researchers compared the efficacy of different chemotherapy regimens in 200 patients with advanced lymphoma; another—nearly 2 years late—tests immunotherapy against conventional chemotherapy in about 600 people with late-stage lung cancer.

Other leading NIH grantees did only slightly better in Science’s analysis based on data collected from the TrialsTracker website of the University of Oxford, which automatically mines information from The University of Texas MD Anderson Cancer Center and the Mayo Clinic both failed to report results on time, or at all, in about two-thirds of their trials. Yale University failed to do so in 84% of its trials. NIH’s own institutes also had a bad record. They are directly responsible for reporting results when they sponsor studies done by agency staff or some grantees, and the top four NIH institute sponsors, taken together, reported results late or not at all in more than six of every 10 trials Science looked at.

Contacted for comment, none of the institutions disputed the findings of this investigation. In all 4768 trials Science checked, sponsors violated the reporting law more than 55% of the time. And in hundreds of cases where the sponsors got credit for reporting trial results, they have yet to be publicly posted because of quality lapses flagged by staff (see sidebar).

Although the 2017 rule, and officials’ statements at the time, promised aggressive enforcement and stiff penalties, neither NIH nor FDA has cracked down. FDA now says it won’t brandish its big stick—penalties of up to $12,103 a day for failing to report a trial’s results—until after the agency issues further “guidance” on how it will exercise that power. It has not set a date. NIH said at a 2016 briefing on the final rule that it would cut off grants to those who ignore the trial reporting requirements, as authorized in the 2007 law, but so far has not done so.

Missed deadlines

Among more than 4700 clinical trials examined by Science, less than 45% had their results reported early or on time to reported113223.7%213044.7%Reported ontime or earlyReported late(GRAPHIC) N. DESAI/SCIENCE; (DATA) CLINICALTRIALS.GOV, VIA TRIALSTRACKER

Many scientists who conduct clinical trials, and their sponsors or funders, have downplayed concerns about late or missing results in Researchers, doctors, and patients can instead learn about trial outcomes from peer-reviewed publications, they say. But thousands of trials are never published, particularly when they find treatments ineffective, history has shown. also uses a common format, allowing relatively easy comparisons of results across trials that journal articles rarely make possible. Doctors, researchers, and potential trial participants rely on the site, to judge from its 215 million monthly page views.

Deborah Zarin, a physician at Brigham and Women’s Hospital and Harvard who headed between 2005 and 2018, says the Science findings show failures of the research culture, FDA, and NIH. “If this was a priority for the leadership of NIH, then they could ensure that high-quality, timely reporting happened all of the time,” says Zarin, an NIH-paid research consultant for the database. “You can set up processes so trial reporting is an expectation. You can’t pass ‘go’ and collect $200 until this is done.”

Zarin, who works in a program to advance clinical research, adds that the problem persists because “reporting to is frequently seen by sponsors, funders, and trialists as an annoying administrative and perhaps legal burden, not a scientific imperative. Human nature being what it is, people follow the requirements when forced to do so.”

NIH and FDA officials do not seem inclined to apply that pressure. Lyric Jorgenson, NIH deputy director for science policy, says her agency has been “trying to change the culture of how clinical trial results are reported and disseminated; not so much on the ‘aha, we caught you,’ as much as getting people to understand the value, and making it as easy as possible to share and disseminate results.” To that end, she says, staff have educated researchers about the website and improved its usability.

As for FDA, Patrick McNeilly, an official at the agency who handles trial enforcement matters, recently told an industry conference session on that “FDA has limited resources, and we encourage voluntary compliance.” He said the agency also reviews reporting of information on as part of inspections of trial sites, or when it receives complaints.

McNeilly declined an interview request, but at the conference he discounted violations of reporting requirements found by journalists and watchdog groups. “We’re not going to blanketly accept an entire list of trials that people say are noncompliant,” he said. Such determinations require “nonpublic information” submitted to the agency by trial sponsors. In response to Science’s findings, a spokesperson said an absence of posted results on did not mean a trial sponsor has broken the 2007 law.

Yet that law and the 2017 final rule detail only a few exemptions that would allow trial sponsors to withhold results on the basis of nonpublic information. The very few registered trials that qualify for those exemptions are not flagged as violators by TrialsTracker or in Science’s analysis.

CONGRESS APPROVED THE CREATION OF in 1997, after allegations that patients were harmed because companies withheld evidence showing their medicines were ineffective or hazardous. A widely cited case involved the GlaxoSmithKline antidepressant Paxil (paroxetine). According to legal filings and a report in The BMJ, the firm held secret data showing that in clinical trials the drug was ineffective and caused suicidal thoughts in teenagers, yet encouraged doctors to prescribe it for young people.

Registration was only required initially for trials of treatments for serious or life-threatening diseases. But the 2007 law, the Food and Drug Administration Amendments Act, required sponsors to register a much broader range of trials within 21 days of enrolling the first patient, and to post summary results, adverse events, and other data to within 1 year of collecting the last patient data. Although many trials, such as industry-sponsored early-stage evaluations of drug safety, are exempt from reporting, about 326,000 have been registered, and results have been posted for more than 40,000.

Yet until 2015, even the most active investigators at clinical research institutions treated the law more as a suggestion—not surprising given that the government enforced no penalties and did not publicly identify violators. A report on the news website STAT by this author and Talia Bronshtein first drew significant attention to specific trial sponsors—companies, government agencies, universities, and individuals—that routinely ignored reporting requirements. It sparked immediate improvement, according to NIH. (Those same authors documented some of that improvement in a 2018 STAT article.)

At a 2016 press briefing, NIH and FDA rolled out the final rule, aimed at boosting even greater compliance with the 2007 law. It took effect in January 2017, with first deadlines for results, and ostensibly enforcement, 1 year later. Then–FDA Commissioner Robert Califf said it would thereafter “be pretty hard to hide that you are doing a clinical trial or hide the result.” FDA, he vowed, was finally prepared, if necessary, to enforce the daily $10,000 penalty for noncompliance allowed under the law. (Adjusted for inflation, that figure recently rose above $12,000.)

“I don’t think anybody wants to be on the wall of shame,” NIH Director Francis Collins said at the press event, promising that NIH would publicly flag reporting violations on itself.

“We are serious about this,” Collins said, threatening for the first time to enforce provisions of the 2007 law that allow NIH to rescind funding to grantees who violate the statute. “It’s hard to herd cats, but you can … take their food away,” he said. “This is about maintaining the trust that we have with participants in clinical trials. … If we fail to live up to that expectation, then that is an ethical failure.”

Three years later, TrialsTracker conservatively estimates that FDA could have collected more than $6 billion in penalties so far. The agency has yet to demand a single dollar. And despite more than 2600 trials for which results are overdue or were filed late, NIH has yet to withhold a single grant as a result or post a single violation notice on No “wall of shame” exists.

“Public-facing websites run by the government should be accurate. That’s not asking much,” Senator Chuck Grassley (R–IA), who advocated for the 2007 law, wrote in an email after reviewing a summary of the Science findings. “It’s a question of basic management and agency competence. The government has a duty to police its work product, especially because the public trusts .gov websites will be accurate and reliable.”

To physician Ben Goldacre, who directs the Oxford program behind TrialsTracker, “The lack of urgency is really troubling.”

Why do you think so few clinical trail results and information is not submitted? What is the cost to taxpayers, patients and the community? Why? Do you trust this process?

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Virginia Beach Psychiatrist sentenced to prison for healthcare fraud scheme

1dimitri-houtteman-unsplash Shidonna Raven Garden and Cook

Source: 13 News Now
Feature Photo Source: Dimitri Houtteman

The scheme involved overbilling healthcare benefit programs by seeing patients for only five to 10 minutes but then billing them for 41 to 63 minutes on average.

VIRGINIA BEACH, Va. — A Virginia Beach doctor was sentenced on Thursday to over two years in prison for defrauding Medicare, Medicaid, and Tricare, and other health care benefits programs out of hundreds of thousands of dollars.

The Department of Justice said 64-year-old Udaya K. Shetty also agreed to pay over $1 million to settle related civil claims on top of the prison sentence.

According to court documents, Shetty was a licensed psychiatrist practicing medicine at his practice, Behavioral & Neuropsychiatric Group. Starting in 2013, he created a scheme where he could overbill healthcare benefit programs by seeing patients for only five to 10 minutes but then billing for services that were on average 41 to 63 minutes long.

Shetty instructed his staff to often double, triple, or even quadruple book appointment times. The fraud started to become apparent when investigators discovered that on dozens of instances Shetty would need more than 24 hours a day of working to perform the services for which he billed.

RELATED: Virginia doctor admits to writing fake prescriptions for black market

In 2017, Shetty closed his practice and joined another psychiatric practice, Quietly Radiant Psychiatric Services. While there, Shetty and one of his former employees, Mary Otto, engaged in a similar scheme. Although other Quietly Radiant staff members were responsible for billing, Shetty directed Otto to access the billing system and change all of his billing data to a higher billing rate.

Otto complied and changed the data without the knowledge of Quietly Radiant’s staff. As a result of their actions, Shetty and Otto defrauded various healthcare benefit programs of more than $450,000.

Otto pled guilty for her role in the scheme and was sentenced to 15 months in prison on January 10.

In regards to the civil settlement, Shetty agreed to pay $1,078,000 to the United States and the Commonwealth of Virginia to resolve his liability under the False Claims Act and the Virginia Fraud Against Taxpayers Act for submitting or causing the submission of false claims to the Medicare, Medicaid, and TRICARE programs.

Would you recognize health care fraud when you see it? What does it look like? What are the affects of health care fraud taxpayers, patients and the community?

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Physician ordered to pay $9.5 million in restitution in home health fraud case

Shidonna Raven Garden and Cook

November 23, 2020
Joe Jancsurak
Feature Photo Source: Frank Busch Pzifgmbsxcc

A Texas physician has been sentenced to five years in prison and ordered to pay $9.5 million in restitution for her role in a multi-million Medicare fraud scheme, according to the Department of Justice.

Yolanda Hamilton, M.D., was convicted of making it appear that patients qualified and received home healthcare services, when often they did not. Others reportedly involved in the scheme allegedly paid patients to receive home healthcare services, which often were medically unnecessary, not provided, or both.  

The evidence, according to the Justice Department, also showed that Hamilton required home healthcare agencies to pay an illegal kickback, which the physician disguised as a co-pay, in exchange for her certifying and recertifying patients for home healthcare services. 

Hamilton was convicted of one count of conspiracy to commit healthcare fraud, one count of conspiracy to solicit and receive healthcare kickbacks, and two counts of false statements relating to healthcare matters.

Would you recognize health care fraud if you saw it? What would it look like? What should be done?

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Opinion: For now, it’s unethical to use human challenge studies for SARS-CoV-2 vaccine development

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Source: Proceedings of the National Academy of Sciences of the USA

 View ORCID ProfileJeffrey P. Kahn,  View ORCID ProfileLeslie Meltzer Henry,  View ORCID ProfileAnna C. Mastroianni,  View ORCID ProfileWilbur H. Chen, and  View ORCID ProfileRuth MacklinPNAS November 17, 2020 117 (46) 28538-28542; first published October 29, 2020;

The prospect of a widely available severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine is an increasingly high priority for an effective response to the coronavirus disease 2019 (COVID-19) pandemic and an area of intense interest and attention for professionals, politicians, and the public alike. The understandable desire for such a vaccine has led to significant discussion and even some planning for the possibility of human challenge studies (HCS) as a tool for accelerating the process for identifying, testing, and developing an effective vaccine (13).

Typically, undertaking HCS in vaccine development requires that the disease for which a challenge would be introduced either has an available rescue therapy to treat those who become infected or the disease is known to be self-limiting. There is no rescue therapy for SARS-CoV-2 infection, and proponents of HCS have claimed that the infection is likely to be self-limiting and mild in young, healthy volunteers based on current understanding of the infection. If accurate, the basic requirements for undertaking an HCS could be met if conducted with that population. Proponents further argue that such HCS are ethically acceptable in the current pandemic. Most critically, they contend that these studies are likely to speed the development of effective vaccines.

But based on our assessment of these arguments, we disagree. We believe it is unethical to move forward with such trials at the current time. Whereas proponents of these studies suggest that such studies will accelerate the time to approved vaccines, the facts fail to support these claims. HCS to address SARS-CoV-2 face unacceptable ethics challenges, and, further, undertaking them would do a disservice to the public by undermining already strained confidence in the vaccine development process.

Accelerating Vaccine Approval

There is general consensus among researchers, ethicists, and oversight bodies that HCS can be ethical, provided certain conditions are satisfied (46). Key among those criteria is the requirement that HCS generate sufficient social value to justify exposing healthy volunteers to uncertain risks with no prospect of direct benefit. Proponents of SARS-COV-2 HCS, notably a nonprofit called 1DaySooner started in April to advocate for such trials (7), contend that such studies will provide “enormous social value” by accelerating the timeframe for vaccine development and distribution, thereby saving thousands of lives (8).

The acceleration argument relies on several interconnected assumptions that prove problematic under deeper scrutiny. The first is that SARS-CoV-2 HCS can provide vaccine efficacy data faster than the standard vaccine pathway. Although comparative speed is an accepted scientific justification for conducting HCS, its conventional application is to circumstances in which conducting field studies would be prohibitively difficult because the target pathogen is rarely transmitted in the natural local environment (9). The opposite is true of conducting HCS in a pandemic environment. During the Zika pandemic, for instance, the ability to conduct field trials played a prominent role in a federal ethics committee determination that it was premature to proceed with Zika virus HCS (10). Widespread transmission of SARS-CoV-2 is already facilitating close to 10 active Phase III trials of SARS-CoV-2 vaccine candidates (11). With more field studies likely to follow, the necessity and relative speed of HCS becomes even less compelling.

Technical and logistical aspects of developing and implementing HCS further undercut the assumption that SARS-CoV-2 HCS would result in a viable vaccine faster than the traditional vaccine pathway. Before initiating definitive SARS-CoV-2 efficacy HCS, researchers must develop a suitable challenge model. This requires carefully selecting the challenge strain, manufacturing it in a BSL-3 laboratory that adheres to current Good Manufacturing Practice (cGMP), receiving regulatory approval from the Food and Drug Administration (FDA) or other regulator to administer it to human volunteers, and conducting dose-escalation studies to determine the target dose of the challenge agent that will elicit the level of illness necessary for determining the primary outcome of the efficacy studies. Vaccine experts estimate that in the context of SARS-CoV-2 HCS those steps will collectively take one to two years to complete, leading them to conclude that such studies are “unlikely to accelerate the establishment of vaccine efficacy” (12).

Ultimately, the social value of SARS-CoV-2 HCS (in terms of deaths averted) hinges on the premise that people at greatest risk of COVID-19–related mortality will receive a safe and efficacious vaccine sooner than they would without HCS.

Even if SARS-CoV-2 HCS were to accelerate vaccine development, it is unclear that the FDA will consider data from HCS in its licensing decision. Although the FDA’s recent approval of a cholera vaccine based on efficacy data from HCS might signal the agency’s willingness to make similar determinations in the future (13), the agency is not likely to do so in the context of SARS-CoV-2. The FDA’s latest Guidance for Industry on developing SARS-CoV-2 vaccines not only omits HCS from its discussion of expedited trial designs but also states that to meet vaccine approval standards, “late phase clinical trials…will likely need to enroll many thousands of participants,” including “adequate representation of elderly individuals and individuals with medical comorbidities” (14). Although it is conceivable that HCS initiated 12–24 months from now could generate efficacy data to support the necessary Phase III results for licensing (12), those HCS would not accelerate the current pathway, in which multiple Phase III trials are underway and a licensed vaccine is possible within 6 months.

Ultimately, the social value of SARS-CoV-2 HCS (in terms of deaths averted) hinges on the premise that people at greatest risk of COVID-19–related mortality will receive a safe and efficacious vaccine sooner than they would without HCS. Those high-risk groups include older adults and people who are immunocompromised or have comorbidities, as well as members of Black, Latinx, and Native American communities—groups who are, as emerging evidence demonstrates, at disproportionate risk of serious COVID-19–related outcomes (15). Current proposals and guidelines for conducting SARS-CoV-2 HCS, however, recommend only enrolling young, healthy adults (781617). Although that strategy arguably reduces the risks associated with HCS, it jeopardizes the generalizability of trial results (1819).

Because the safety and efficacy of vaccine formulations and dosing may differ between populations (e.g., based on age), the social value of HCS—in terms of reducing mortality among those at greatest risk—is likely limited. Moreover, the social value of vaccines depends in large part on whether people get vaccinated (20). Ongoing, standard SARS-CoV-2 vaccine trials, however, are currently struggling to recruit participants from some communities of color, and in recent polls respondents who self-identified as Black were more than twice as likely as white respondents to be leery of taking a SARS-CoV-2 vaccine (21). Well-intentioned recruitment from communities of color into HCS may nevertheless evoke historical mistrust over discrimination in research and elicit concerns of exploitation, either of which could detrimentally impact vaccine uptake in at-risk communities.

Acceptable Risk–Benefit

For research to be ethically sound, the relationship between risks and potential benefits must be reasonable. IRBs are charged with making that assessment, but in the case of human challenge studies, knowledge about infection with SARS-CoV-2 and potential resulting COVID-19 illness continues to evolve; many unknowns remain. Despite the earlier belief that young, healthy adults (the proposed subjects) experience a mild form of COVID-19 and recover quickly, recent data have revealed that this population can experience significant adverse effects when they become infected (2224). An additional shortcoming of HCS is that some risks of the vaccine itself may emerge only when a larger number of individuals have been vaccinated.

Because the proposed HCS will enroll only young adults, the result is a much narrower potential benefit than proponents have assumed. Vaccine trials using the standard methodology would still be needed to ensure safety and efficacy for the vast numbers of people who do not fit the narrow inclusion criteria of HCS.

Taken together, these considerations make it virtually impossible for IRBs to make an appropriate assessment of the risk–benefit balance. If the potential benefit is low because Phase III field efficacy studies would still be necessary, and larger numbers of participants would be needed to obtain adequate safety data, this would call into question an acceptable balance of benefits over the risks to participants in HCS.

The uncertainty of information about risks to participants from both the infection and the vaccine makes adequate disclosure next to impossible in the informed consent process. Along with the unknown potential benefits to groups other than the age cohort in the study, accurate, detailed information in informed consent documents is bound to be limited. Despite acknowledgment in consent forms that participants may not experience direct benefits from the experimental intervention, it is entirely possible that volunteers may labor under a “preventive misconception” that they will receive some protection from infection by their participation. This is analogous to the so-called “therapeutic misconception” in research on experimental therapies, in which research subjects agree to participate in part based on the misconception that they are likely to gain some therapeutic benefit as a result.

Very little has been said so far in the literature about payment or other incentives to potential HCS volunteers (2526). A misconception about immunological protection is only one of several such incentives, which could include monetary payments, a common inducement in HCS for other diseases. More information is needed about such incentives or misconceptions before IRBs can meaningfully assess the ethical acceptability of proposed HCS for COVID-19.

Resources Required

Current arguments in favor of SARS-CoV-2 HCS fail to account for the pandemic realities of global, national, and local resource constraints and the extent to which diversion of scarce health care resources could compromise local pandemic response.

We find such HCS proposals to be flawed in their core claim about speeding vaccine development, and we believe that the risk–benefit balance for such HCS is both too uncertain and likely to be unacceptable, even with greater information.

Any proposed SARS-CoV-2 HCS would necessarily provide all medical care for study participants who become infected during the trial. Some have even advocated that participants receive “priority” access to critical care resources (clinical support, ventilators, drugs, and other interventions) “notwithstanding the possibility of severe shortages” (16). Others who have closely examined the ethical requirements for these trials, in contrast, argue convincingly that HCS sponsors should be required to show that HCS do not “unduly compete for scarce resources” that affect local pandemic response (5).

As part of a risk minimization strategy, trial sites should be geographically located in high prevalence areas to reduce the risk associated with intentional infection [i.e., recruiting those who have an otherwise high baseline risk of exposure (16)]. Unfortunately, these are areas with the most demands on essential public health resources.

The reality is that essential supplies for conducting SARS-CoV-2 HCS are already limited because of the pandemic (18), with communities, states, and even national governments competing for access (e.g., personal protective equipment, ventilators, oxygen, supportive care, treatments such as remdesivir and convalescent plasma, and even testing). Human resources are similarly strained by the pandemic, and HCS may remove critical trained personnel from provision of urgent health care: Highly sought-after health care workers on the study team must have training in biocontainment and infection control, and planning must further account for worker quarantine and medical treatment if they test positive.

We believe that the unique impact that a SARS-CoV-2 HCS places on scarce and already strained resources during a pandemic must be given considerable weight in any justification of these trials. In contrast to community-based field studies, which are effectively outpatient rather than inpatient trials, a SARS-CoV-2 HCS will place greater demands on medical resources, including specially trained personnel, biocontainment units, and dedicated hospital rooms. Decisions to further burden an already battered public health system with intentional infection—including the potential for unintentional release—will involve hard choices and consultation with, and buy-in from, affected stakeholders, including public health authorities, regulators, regional and local institutions, health care providers, and communities already hard hit by infection. Coordination is essential to ensure that decisions are not made unilaterally (27). These efforts will take time, further slowing any hoped for promise of acceleration.

HCS and Public Mistrust

Undertaking an HCS in the context of this pandemic risks fueling and potentially worsening levels of public mistrust. All aspects of the public health response to the pandemic have been politicized, feeding concerns across a wide spectrum of the population (20). This includes those traditionally skeptical about vaccine policy (so-called anti-vaxxers) as well as proponents of vaccine development and drug discovery who fear that approval will be hasty in response to intense political pressures, a concern only reinforced by both Russian and Chinese “approval” of candidate vaccines that had not gone through a phase III trial. Concerns within the science community have prompted hundreds of medical and public health experts to issue an open letter to the FDA calling for assurances that full and transparent review of vaccine candidates will be undertaken, and nine pharmaceutical companies have felt the need to make a collective pledge “to uphold the integrity of the scientific process” (2829). Introducing HCS that do not meet basic principles of research ethics and vaccine development are likely to play into concerns that shortcuts are being taken and that science is being politicized, further undermining public trust (19).

In sum, the severity of COVID-19, and the lack of a cure or effective treatment, make it unethical, at this point in time, to institute HCS for the development of a SARS-CoV-2 vaccine. We think proponents’ core claim about speeding vaccine development is flawed, and we believe that the risk–benefit balance for such HCS is both too uncertain and likely to be unacceptable, even with greater information. In addition, issues of resource allocation are critically important and difficult to justify. Vaccine trials aiming to undertake risky and uncertain steps in human subject research—particularly those that depart from standard approaches to protection of subjects in HCS—risk further exacerbating increasing levels of public mistrust related to SARS-CoV-2 vaccine development. Taken together, we believe that these arguments make undertaking SARS-CoV-2 HCS both unwarranted and unethical. At this critical moment in the response to the pandemic, it would do more harm than good.


  • The authors declare no competing interest.
  • Any opinions, findings, conclusions, or recommendations expressed in this work are those of the authors and have not been endorsed by the National Academy of Sciences.

Published under the PNAS license.


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View Abstract

Like many things, there are different opinions regarding COVID 19 trails and the vaccines that are produced from them even within the medical and science communities. Will you take the vaccine? Why? Why not?

Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

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Portland VA: Human Experiments Unethical, No Consent

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Source: Disabled Veterans
Feature Photo Source: Unsplash, Robina Weermeijer
A consumer group named Public Citizen filed ethics complaints against Portland VA for unethical kidney transplant trails at the facility that lacked consent.

The trial paperwork indicated the kidney transplant trial subjects were deemed “nonhuman” despite kidneys being transplanted into live humans. The study failed to seek informed consent through normal channels because of the “nonhuman” classification.

The Portland VA Medical Center and University of California, San Francisco (UCSF) were involved in the study. Drs. Daren Malinoski and Claus Niemann led the study. Dr. Malinoski works at Portland VA. The Institutional Review Board (IRB) was conducted by UCSF.

The complaint from Public Citizen said participants in the study were not informed of the nature of the transplanted kidneys. Those kidneys came from brain dead donor bodies where the body was cooled prior to removal of the kidney as part of a study. The kidney gathered at experimental temperatures was then placed into a live human for research.

The purpose of the study was to gauge whether colder kidneys would result in quicker acceptance of the organ. The meta-goal of the study was to find cheaper ways to transplant kidneys.


The recipients were apparently not informed. According to the Public Citizen complaint, the organizations failed to reach a few obvious and common sense related conclusions prior to the study being conducted:

  • Failure to recognize trial as involving human subjects research
  • Failure to satisfy IRB review and approval requirements

Not surprisingly, these two researchers and the IRB panel failed to recognize the subjects of the study were human. While the donors were brain dead, the recipients of the kidneys subject to the cooling experiment were most certainly human.

Should we be surprised that Ivory Tower type researchers would erroneously conclude recipients of experimentally harvested kidneys are not human? Do you ever wonder if VA at large considers us humans with rights, at all?

The complaint indicates that the error of judgment about the humanness of the study resulted in the participant doctors failing to seek informed consent from the 572 recipients.

This news made me wonder an obvious question:

How many more similarly mistaken IRB reviews have concluded veterans are not humans where informed consent is required?

In the name of conducting human experiments to save money, researchers apparently concluded humans were not humans. How many of these “nonhumans” were veterans?


What are the benefits to medical professionals Not to obtain informed consent? What are the financial benefits to the medical professoinals Not to obtain informed consent? Do the ends justify the means?

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Ex-owner of home health care company gets 1 year for $863,000 Medicaid fraud

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Source: The Virginia Pilot

The former owner of a home health care company in Portsmouth was sentenced Wednesday to one year in federal prison for her role in an $863,600 Medicaid fraud.

Prosecutors had wanted 54-year-old Sandy Varzmanesh locked up for at least 2½ years while the defense wanted house arrest or probation.

Varzmanesh, formerly of P&S Home Health Care Solutions, pleaded guilty last September to one count of health care fraud.

According to court documents, Varzmanesh’s company was authorized to provide home health care and respite care services for Medicaid patients. To do so, however, the company was supposed to have a registered nurse review requests to ensure that the services were medically necessary.

Varzmanesh, also known as Sandy Vincent, didn’t always secure the registered nurse’s approval, though. Documents said Varzmanesh, a lesser-qualified Licensed Practical Nurse, sometimes forged an RN’s signature on the required paperwork.

The scheme stretched from about December 2010 through June 2016.Advertisement

In all, Varzmanesh billed Medicaid $764,826 for numerous patients who had not been assessed by registered nurses and were therefore not eligible for the services provided.

From June 2011 through June 2016, she also collected $98,774 for respite care services that were provided ineligible Medicaid recipients. Some of the patients lived in group homes with other P&S clients.

“This was systemic and routine over a period of years, not a onetime transgression,” Assistant U.S. Attorney Elizabeth Yusi wrote in court documents, arguing Varzmanesh was motivated by greed.

“Varzmanesh wanted money to support her lavish lifestyle, which included travel for her family and beauty and nail salons,” she said.

Defense attorney Trey Kelleter described his client as a “compassionate friend and mentor who has devoted herself to the care of others, both in her profession as a nurse and as a daughter who has shouldered, with love, the responsibility for taking care of her physically and mentally disabled mother.” He said she lives with her mother in a two-bedroom, one-bath apartment and works during the day when an aide is available to visit with her mother.

Providing the court several letters from family, friends and the loved ones of former patients, Kelleter asked the court to show his client mercy.

While federal sentencing guidelines recommended a sentence of at least 2½ years, he explained that was largely because they are based on the fraud’s gross proceeds. And that, he said, gives the world an out sized view of the crime at hand.

“A thief who takes $860,000 in cash from an account solely for personal gain receives the same points as Ms. Varzmanesh, who skirted eligibility requirements but whose business nonetheless provided actual services that benefited dozens and dozens of patients,” Kelleter said in court documents.

He described those services as “needed” and “life-enhancing.”

The argument swayed U.S. District Judge Henry C. Morgan Jr., who ultimately handed down the reduced sentence.

Sometimes these health care professionals partner with people in your very own community to commit their acts of fraud. These people could be your “friends”, neighbors or even “family”. Would you recognize health care fraud when you see it? What does it look like? What should you do when you see it? Sometimes health care fraud results in poor health out comes (where patients health deteriorates) and even death often costing the tax payers unspeakable amounts of money. Where is their mercy?

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Memphis woman sentenced in health care fraud case, charged in Paycheck Protection Program scheme

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Source: By
Staff| November 9, 2020 at 4:01 PM CST – Updated November 9 at 4:03 PM

MEMPHIS, Tenn. (WMC) – A 27-year-old Memphis woman has been sentenced for health care fraud and is also facing new charges for her involvement in a Paycheck Protection Program loan scheme.

The U.S. Attorney’s Office for the Western District of Tennessee says Princess Terry is set to spend 65 months in federal prison for healthcare fraud and aggravated identity theft while also facing new charges for wire fraud and making a false statement in connection with a loan application.

Terry owned and operated a home health care service called Caring Heart Memphis which provided services to elderly patients like in-home aides, nursing and physical and occupational therapy.

In the statement below, the U.S. Attorney’s Office describes the details of the crime:

“Between approximately January 1, 2016, and June 27, 2019, Terry submitted over $2 million in fraudulent billing to Humana, a private health insurance provider, for services that were not actually rendered. Terry’s fraudulent billing practices included numerous instances of billing for home health services on days when patients were actually hospitalized, billing for services in excess of 24 hours in a given day for the same patient, and billing for services purportedly rendered after the patient was deceased.”

Officials say Terry also committed identity theft by forging patient’s signatures without their knowledge or consent on forms describing services that were not performed.

In May 2020, Terry allegedly told the Small Business Association and two other financial organizations that Caring Hearts Memphis was still in business even though it had been non-operational with no employees since 2017.

She was able to obtain $290,000 in loan funds from the Paycheck Protection Program which was created in response to the COVID-19 pandemic to help small businesses fulfill payroll obligations and remain in business.

The new charges are expected to be presented to a grand jury at a later date.

Copyright 2020 WMC. All rights reserved.

Often third party companies and organizations assist with health care fraud submitting information to insurance companies and government agencies in hopes of a payday. Those committing fraud often do so without the consent, knowledge nor authorization of supposed patients often signing their name, as stated above.

Would you recognize health care fraud if you saw it? What does it look like? What should you do?

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