Category: Blog

The Future of Litigating Fraudulent Medicare Claims

The False Claims Act (“FCA”), which is mainly used to litigate fraudulent Medicare claims, is being challenged in the Supreme Court. In U.S. ex. Rel. Polansky v. Executive Health Resources, Inc., Polansky argues that in granting the Department of Justice (“DOJ”) the ability to move to dismiss the realtor’s FCA complaint, the FCA deprives realtors of their status and rights. Oral arguments commenced in January 2023, and a decision is expected this Summer regarding the future of the FCA.

The FCA was enacted in 1863 during President Lincoln’s tenure. The FCA allows individuals (“whistleblowers”) to pursue litigation against those the whistleblower believes have fraudulently billed the federal government. In 2022, 90% of all FCA settlements and judgments were related to healthcare fraud. Healthcare fraud may be billing for medical services not rendered, misrepresentation of covered medical procedures as non-covered medical procedures, altering patient’s diagnoses to receive a higher payment, billing for services not performed, accepting kickbacks for referrals, or unbundling procedures and billing a single procedure at every stage of the interaction to receive a higher payment.

The consequence of Medicare fraud is higher insurance premiums for Medicare Advantage policyholders. To make up for Medicare’s payments to fraudulent claims, Medicare Advantage plans adjust premium prices for the coming year to make up for fraudulent claims . Thus, policyholders pay more monthly to mitigate the Medicare Advantage plans’ payments toward fraudulent claims.

The FCA provides a pathway for whistleblowers who have experienced Medicare fraud. The DOJ has intervened in 261 cases this past year, the highest amount since 1993. However, in 2022, for the first time in history, the recovered amount for cases where the DOJ has not intervened surpassed the amount recovered in DOJ-intervened cases. Additionally, in that same year, about half of all awards for claims under the FCA were from cases where the DOJ declined to intervene.

In Polansky, the DOJ declined to intervene after investigating the claim for two years but maintained the right to move to dismiss. About seven years after the case’s inception, the DOJ then moved to dismiss the lawsuit, citing that the cost of litigating the claim did not outweigh the benefit of an award. Polansky is claiming the DOJ’s dismissal of the claim, stopping litigation in its tracks, is a deprivation of the whistleblower’s rights. Currently, the DOJ has broad discretion in dismissing claims under the FCA. If the Supreme Court finds Polansky’s arguments convincing, then the ability of whistleblowers to sue medical care providers for fraudulent billing would increase, as the DOJ would be barred from dismissing claims freely. However, the DOJ states that its broad discretion, which allows the DOJ to dismiss claims where the cost of litigating will not benefit the government or whistleblower, should be maintained.

Today, committing Medicare fraud is less of a challenge than one would assume. A fake company was set up in Florida as a Medicare fraud front. All that was required was setting up a P.O. box for the fake company. The fake company billed Medicare over $500,000 for patients that did not exist. On average, taxpayers lose more than $100 billion annually to Medicare and Medicaid fraud.

Furthermore, Medicare fraud creates expensive repercussions for policyholders. Although the FCA creates an avenue for individuals to sue billers who have engaged in fraudulent practices, if the Supreme Court agrees with the government, the decision may result in a chilling effect among policyholders,  reducing FCA litigation and compounding the damaging impacts for individuals. 

The Implications of Data-Sharing Skepticism in Healthcare

There may be no stranger with whom the average person shares more private details of their life with than their doctor. The primary healthcare mechanism to protect patient privacy in healthcare, the Health Insurance Portability and Accountability Act (“HIPAA”) was passed in 1996, but was, as its title suggests, heavily focused on insurance-related concerns, and left gaping holes in much of the healthcare data privacy space. Under HIPAA, personal health information can be sold by healthcare organizations, used for marketing purposes, and shared with research organizations, as long as the data is de-identified, or the patient authorizes such uses.

While many patients are incredibly skeptical of their health information being shared, even with identifying details stripped from the data, there are incredibly important reasons to embrace and support a robust data-sharing model: to provide drug manufacturers with patient data about side effects and adverse reactions, to allow researchers to uncover and analyze systemic trends and anomalies, and to allow for the most comprehensive and holistic data-driven modeling. Much of patient skepticism may be due to the unfamiliarity with how their data is used – in a 2022 survey, only 20% of patients indicated an understanding of who has access to their healthcare information.

            Two recent developments have further exacerbated the problems around patient skepticism – the post-Dobbs criminalization of abortion, and the furor around TikTok. Although much of the legislation criminalizing abortion targets health care providers and clinical staff, the mere fact that, in some states, abortions are now a felony with potential jail time will likely cause patient unrest and fear. Even though Justice Kavanaugh’s concurrence in the Dobbs decision suggested that pregnant persons will still have the right to travel out of state to obtain abortion services, there is little clarity or guidance on what data law enforcement may be able to collect, even if the abortion occurred out-of-state. If patient data privacy concerns related to abortion procedures are not addressed, the skepticism and fear may seep into other types of healthcare and further impede the robust sharing of healthcare information.

            To that end, the discussions around banning TikTok demonstrate the general concern that user data, including personal health information, may be in the hands of the Chinese Communist Party, which would have far-reaching implications. Like the concerns surrounding abortion, skepticism and fear about what data from social media is being shared, and with whom, decreases consumer/patient willingness to share personal information in ways that may be beneficial to them.

There is already an undeniable overlap between healthcare and social media. One of the risks of conflating the two is that third-party data sharing in the healthcare space may be inadvertently equated with sharing data with social media platforms. For the purposes of sharing data with third parties, even when de-identified, should AstraZeneca, collecting patient information to improve a vaccine, be considered equivalent to TikTok collecting information for advertising purposes?

Much of the current proposed legislation is aimed at increasing data privacy and security. The American Data Privacy and Protection Act (ADPPA), proposed last year, would create additional protections for sensitive data, though data covered under HIPAA is outside its scope. Last month, Democratic senators introduced the Upholding Protections for Health and Online Location Data Privacy Act (UPHOLD), which would give consumers more control over their health data and restrict companies’ ability to collect and/or use data without patient consent. On the other hand, the Health Information Technology for Economic and Clinical Health Act (HITECH), enacted in 2009, was intended to address privacy and data security concerns by increasing the civil and criminal penalties associated with HIPAA violations, with the goal of promoting the “adoption and meaningful use of health information technology.”

Despite the continued emphasis on increasing and broadening data privacy rights and consumers’ ability to control how their data is disseminated, it is critical that the importance of sharing health data with relevant third parties not be minimized or vilified. Innovation in healthcare depends on pharmaceutical companies, academic researchers, and others, having access to the most current, comprehensive patient data.

Telehealth or Telefraud? The Rise yet Continued Short-Comings of Telehealth Post-Pandemic.

Although the word telehealth is new in most of our vocabularies, the idea itself is not. As early as 1925, doctors were diagnosing patients over the radio, and in 1959 patients and physicians were using video telecommunications to connect with one another. 

Telehealth now, however, is booming. In the year between March 2019 to March 2020, Telehealth usage increased an astounding 154%. Among Medicaid beneficiaries in a select five states, telehealth usage increased 15x from the pre-pandemic usage of 2.1 million visits per year, to over 32 million visits from March 2020 to April 2021.

Although telehealth has its inherent benefits , such as allowing patients to visit doctors from the comfort of their homes, thus saving them time, money, and allowing for fewer missed hours from work, it also has its drawbacks. Disadvantages to telehealth include racial disparities , possible technical difficulties between patient and doctor, misdiagnosis, and privacy concerns.

One of the leading disparities in telehealth is the digital divide. In a study conducted by the University of Houston, head researcher, Omolola Adepoju, found that only one in four families earning $30,000 or less have a smart device capable of running telehealth communications software such as Zoom or Skype. Further, the study found that 66% of African Americans and 61% of Hispanics have high-speed internet access, compared with 79% of white households.

Further challenges were illustrated by the National Center for Biotechnology Information (NCBI), which extracted 27 studies from seven databases, and organized the barriers and challenges to telehealth into seven categories. In order of frequency (most frequent challenge to telehealth, to least frequent): technical aspects, privacy/data confidentiality and reimbursement, physical examination and diagnostics, special populations, training of healthcare providers and patients, doctor-patient relationship, and acceptability and satisfaction.

The second biggest barrier to telehealth, as reported in the NCBI’s report, was privacy/data confidentiality concerns. Patients were afraid that using a telehealth service would subject their intimate data to security breaches. These fears were not baseless. During the COVID-19 public health emergency, the Department of Health and Human Services Secretary Alex Azar issued temporary waivers that waived Medicare’s licensure requirements and allowed health providers to use mainstream video-conferencing platforms like Zoom and Google Meet. Further, smartphone apps, sometimes used in place of Zoom and Google Meet, have been found to share personal health information  with third parties.

Although federal policies allowed for health care providers to use popular third party vide conferencing platforms, there are some simple steps we can take to ensure privacy when meeting with health care providers via telehealth. When sharing sensitive health information online, it is important to remember a few precautions we can take to limit the possibility of our information being hacked. First, make sure to keep your devices up to date with antivirus software; second, avoid using public Wi-Fi when accessing telehealth services; and third, avoid accessing telehealth appointments on shared devices. Further, once in an appointment, try to ensure that you are in a private room away from others, and if impossible, let your healthcare provider know, and then you may be able to send sensitive information via text or email through their own protected portal rather than speaking aloud.

As COVID-19 cases are trending down and are presenting less of a public health emergency (which the Department of Health and Human Services plans to officially end on May 11, 2023), it is time for lawmakers and politicians to seriously think about the impacts unregulated telehealth has on the privacy of its users, especially as it relates to marginalized groups.

Ozempic: The New Miracle Weight Loss Drug?

Ozempic is an antidiabetic medication developed by Novo Nordisk in 2012 and the United States Food and Drug Administration (FDA) first approved the medication in 2017. Used for the treatment of type 2 diabetes, Ozempic is designed to be injected once a week in the stomach, thigh, or arm. In February, Novo Nordisk warned of supply constraints this year on Ozempic. In March, after months of shortages, the FDA announced that Ozempic is back on the shelves in the United States. The demand for Ozempic was assumed to be partly driven by prescriptions for non-diabetic patients seeking to lose weight, which is outside the drug’s approved indication.

Ozempic impacts weight via two key mechanisms. First, it affects the hunger centers in the brain,specifically in the hypothalamus, reducing hunger, appetite and cravings. Second, it slows the rate of stomach emptying, which effectively prolongs fullness and satiety after meals. The net result is decreased hunger, prolonged fullness, and, ultimately, weight loss. In a clinical trial sponsored by Novo Nordisk, 1,961 adults with excess weight or obesity who did not have diabetes were given 2.4 milligrams of semaglutide, the active ingredient in Ozempic, or a placebo once a week for 68 weeks, along with lifestyle intervention. Those who took semaglutide lost 14.9 percent of their body weight compared with 2.4 percent for those who took the placebo.

In 2022, Ozempic exploded onto the scene and gained attention among celebrities and TikTok influencers who were trying to lose weight in short periods of time. Although Ozempic can help someone lose fifteen to twenty percent of their body weight, any lost weight reportedly comes right back if you do not take the drug every week. Thus, people who start a prescription typically do not stop taking it, even when they reach their goal weight.

People taking Ozempic for both FDA approved and off-label use may experience side effects. These include nausea, dehydration, fatigue, malaise, diarrhea, and constipation. In rare cases, the medication could increase the risk of pancreatitis. Because the drug has not been systematically tested in people with lower body weights it is possible that patients outside of the group the drug is intended for could experience more intense side effects. Without more research, it is unclear just how damaging those side effects could be.

In addition to these physical side effects, there are also psychological side effects. Dieting is one of the leading risks for developing an eating disorder and medications such as Ozempic could lead to more disordered eating as people try to avoid regaining weight.

Doctors say there is not enough evidence to know whether Ozempic might be beneficial or dangerous for people who fall outside of the FDA’s criteria. As tempting as the prospect of a “miracle drug” for weight loss may be, experts caution against people seeking out the medication for off-label use.

Cancer in America: History, Progress, and Challenges Ahead

“Its palliation is a daily task, its cure is a fervent hope.”- William Castle, describing leukemia in 1950.

In The Histories, Herodotus records the story of Queen Atoosa of Persia (Atoosa), specifically the unusual illness that struck her in the form of a bleeding lump in her breast rising from a malevolent form of breast cancer. Following the discovery, Atoosa self-quarantined, yet was persuaded by the Greek slave, Democedes, to excise the tumor. The rest of Atoosa’s story vanished from the Histories, but we do know Atoosa’s illness was the first recorded case of mastitis, often interpreted as a symptom of inflammatory breast cancer.

Atoosa’s story, however, was an exception in the fact that cancer was exceedingly rare in the distant past. Despite the existence of ancient medical literature terms for migraines (Mesopotamia), seizures (Egypt), and leprosy-like illnesses (Book of Leviticus), the ancient medical literature on cancer is absent. Explanations for this absence are no mystery. Cancer is mostly an age-related disease; the risk of breast cancer is one in 400 for women under thirty and one in seven for women over seventy. The spectrum of cancers is influenced by changes in modern life, including the decline in stomach cancers following the introduction of modern refrigerating.

Cancer’s name originated in the fourth century BC as karkinos, from the Greek word for “crab.” Cancer, seen as a tumor with swollen blood vessels around it, reminded Hippocrates of a crab dug in the sand with its legs spread in a circle. Hippocrates described illnesses as an unbalancing of the four cardinal fluids: blood, black bile, yellow bile, and phlegm. Inflammation was the excess of blood, jaundice was the excess of yellow bile, and tubercles was the excess of green phlegm. For Galen, the Greek doctor who practiced among the Romans in the second century AD, cancer indicated the excess of black bile. Galen supposed this excess was evident because it came from one other illness: depression. For Galen, depression and cancer were the physical and psychic diseases that intertwined due to the excess of black bile, and tumors were symptoms of deep bodily dysfunction.

Galen died in 200 AD, but his black bile theory of cancer persisted for centuries. This theory lost ground in the sixteenth century; however, due to the confirmation of the non-existence of black bile. New theories about the origins of cancer developed in the seventeenth and eighteenth centuries, including cancer being the result of viruses and organ lesions.

Critically, the modern understanding of cancer began in the eighteenth history, with physicians exploring the association between cancers and chemical exposure. In 1775, Percivall Pott noticed the development of cancers among chimney sweeps and suggested that testicular cancer resulted from soot. In the nineteenth century, Ludwig Rehn observed the association between exposure to aniline dye and bladder cancer of industrial workers.

The twentieth century saw major medical breakthroughs in our understanding of cancer, including Rous’s discovery of the first tumor virus, Papanicolau’s development of the Pap test, the establishment of the National Cancer Institute, confirmation of the link between cigarette smoking and lung cancer, and the development of radiation, chemotherapy, Rituximab, Gardasil, and the Cancer Moonshot program. The history of cancer is a story of discovery, centuries of an inability to understand cancer, and an untold amount of suffering and grief of those affected. I also present this history to highlight the advances in cancer treatment in recent decades and how those developments impact cancer mortality.

In January, the American Cancer Society released its Cancer Statistics 2023 report, which revealed that overall cancer mortality has decreased by thirty-three percent since 1991. Data also revealed that women between the ages of twenty and twenty-four had a sixty-five percent reduction in cervical cancer from 2012 to 2019; importantly, this age range was the first to receive the human papillomavirus (HPV) vaccine. Additional findings in the report include the following:

  • A three percent annual increase in prostate cancer from 2014 – 2019.
  • A more than fifty percent decline in mortality rates from cancer for children from 1970 to 2020.
  • Persistent disparities in prostate cancer mortality rates among Black men, which are two to four times higher than those in any other racial or ethnic group.
  • A continual decline in cancer mortality from 2019 – 2020 (1.5 percent), despite disruptions from the COVID-19 pandemic.
  • Lung cancer incidence decreased on an annual basis for both women (1.1 percent) and men (2.6 percent).

The overall decline in cancer mortality in the United States results from reductions in smoking, advances in treatment, and increased early detection for some cancers, translating to 3.8 million fewer cancer deaths from 1991 – 2020. Significant declines in mortality rates from childhood cancer result from improvements in treatment and high participation in clinical trials for the most common cancers (e.g., leukemia), especially among children. Though a monumental achievement, the fight against cancer ensues and will require intense collaboration among policymakers and leaders in the medical sector to fund the development of more effective treatments and, eventually, a cure. Equally important will be a push to close inequities in treatment, as the risk of overall cancer death was twelve percent higher in Black individuals than White individuals; mortality rates in Black women remain about forty percent higher than in White women, despite a lower incidence of cancer.

Leadership from the White House is and will be critical in eliminating cancer. In 2022, the Biden Administration relaunched the Cancer Moonshot Initiative, committing the United States to reduce the death rate from cancer by half by 2047. The Administration also called on Congress to fund the President’s proposal to create the Advanced Research Projects Agency for Health (ARPA-H), a program aimed at further innovating health research, starting with a focus on cancer and Alzheimer’s. Numerous accomplishments followed the relaunch of the Initiative, which include over $200 million in grants issued by the Centers for Disease Control and Prevention (CDC) to advance prevention and screening, a large national trial launched by the National Cancer Institute to develop effective blood tests to detect one or more cancers, implementation of the PACT Act to expand health care access to veterans exposed to toxic burn pits, and proposed rules by the Food and Drug Administration to prohibit menthol cigarettes and flavored cigars.

Importantly, expanding health care coverage to victims of carcinogens from environmental disasters will be a critical prevention and treatment strategy. Recent environmental disasters such as the train derailment in East Palestine, Ohio highlight how victims of these disasters are at risk of developing cancers if federal officials do not respond quickly. The train derailment in East Palestine left a trail of toxic chemicals, including cancer-causing vinyl chloride. Lawmakers in Ohio and U.S. Department of Health and Human Services officials are calling for the use of Section 10323 of the Affordable Care Act (ACA), which promises Medicare to Americans exposed to certain environmental health hazards. Section 10323 was created in the wake of a vermiculite mine that spread deadly airborne asbestos in Libby, Montana, killing hundreds and sickening thousands. Following the disaster, former U.S. Senate Max Baucus (D-MT) inserted Section 10323 into the ACA to cover the whole community of Libby with Medicare. Similar conversations have arisen about providing Medicare coverage for the whole East Palestine Community, though legal experts, including Lawrence Gostin of Georgetown University Law Center, believe implementing this provision in East Palestine would be unlikely unless the federal government established a pilot program to ensure broader coverage. Even if the provision were to fail to cover the residents of East Palestine, the push to increase Medicare coverage for citizens knowingly exposed to carcinogens from environmental disasters is an important policy component the Biden Administration and future administrations should consider incorporating into their health care strategies. The fight against cancer, as illustrated by this history, has made significant progress. Much work remains to be done, and good policy can ensure the accomplishment of that work.

The Rise of Ozempic & Prescription Weight Loss Drugs

Ozempic is an injectable drug used to lower blood sugar in adults with type 2 diabetes and to lower the risk of heart disease. But over the past few months, Ozempic has been hailed as a “miracle drug” by celebrities, tech moguls, and social media influencers alike. In September 2022, an article from Variety described how Ozempic injections were used by celebrities across the industry to lose weight ahead of “major events”, with the most enthusiastic users being non-diabetic. Nevertheless, Ozmepic’s rise in popularity is not limited to Hollywood. As of today, TikTok videos with #ozempic have been viewed more than 637.6 million times and will likely continue to rise. While many videos feature prominent influencers on the app, dozens more feature ordinary users documenting their experience taking Ozempic with hashtags such as #ozempicjourney.

The recent popularity surge of Ozempic also coincides with the Food and Drug Administration’s (FDA) approval of another weight-loss drug known as Wegovy in 2021. Similar to Ozempic, Wegovy is a semaglutide injection intended to facilitate weight management in overweight or obese adults. By mimicking hormones that regulate food intake in the brain, Wegovy works as an appetite suppressor. The FDA’s approval of Wegovy resulted in higher demand for the drug and led many to seek out similar weight-loss prescriptions. The rising demand of these drugs led to a shortage of Ozempic in the United Kingdom in May 2022, followed by another shortage in the United States this past February. An article in Time magazine found that over five million prescriptions for Ozempic were written in 2022 alone, along with similar drugs. And in a study published by the New England Journal of Medicine, researchers found that adults with obesity but no diabetes had weight reductions of 5% or more after taking Ozempic for several weeks. 

Beyond its popularity on social media, Ozempic has also been known to have various side effects, including possible thyroid tumors, pancreatitis, kidney failure, and vision changes. One of the most documented side effects is referred to as “Ozempic face”, which can result in fat loss from the face and the appearance of sagging skin due to drastic weight loss. In addition, it is necessary to continue taking Ozempic indefinitely to maintain the weight loss. 

Currently, it is unclear how drugs such as Ozempic and Wegovy may affect people who are of normal weight or fall outside of the FDA’s criteria. While doctors have warned about the dangers of off-label use, the shortage of available prescriptions has made it more difficult for people with diabetes or obesity to have access to it. However, the rising popularity and recent shortages of Ozempic has led to a broader conversation on health and our relationship to food. In recent news, Weight Watchers has announced their acquisition of a telehealth company known as Sequence, which connects patients with doctors who can prescribe Ozempic and other drugs such as Wegovy and Rybelsus. Going forward, it may be useful to consider how the prescription of weight-loss drugs can be improved to provide affordable access for those with certain medical conditions and to educate the public on its effects.