Who Is Getting the Vaccine? Who Isn’t? And Why?

 Two things are obvious. Access to the Covid-19 vaccine has not been equal. And in many cases, the distribution is unrelated to medical need or medical risk.

According to one study, among the 23 states that report the details, Black and Latino people received far smaller shares of the vaccine than their share of cases and deaths. For instance, in Mississippi, Black people make up 38% of the population and 41% of the deaths due to COVID-19, but they’ve received just 17% of the vaccinations.

It will be many years before we know all the dimensions of unequal access to the vaccine, but I am confident that much of what we will find was entirely predictable. Why? Because we have had decades of experience with non-price rationing in health systems in cultures similar to ours and the resulting patterns are clear and unmistakable. (Note: some of what follows was previously reported in my congressional testimony.)

The British National Health Service (NHS) was established in 1948 and it has changed very little in structure in 72 years. Canada’s Medicare system was formally established in 1984 as a “single payer” system, although versions of it existed in some provinces for many years before that. 

When the NHS was founded, the most important, overriding objective was to make health care free of charge at the point of delivery. The reason: there was a widespread belief that health care should be made available on the basis of medical need and not on the basis of income, or social class, or the ability to pay. It was often said, for example, that “health care is a right.” Aneurin Bevan, father of the NHS, declared, “the essence of a satisfactory health service is that rich and poor are treated alike, that poverty is not a disability and wealth is not advantaged.” 

It was fitting therefore, that almost thirty years after the NHS establishment, a Working Group on Inequalities in Health was set up, under the chairmanship of Sir Douglas Black, to study what progress had been made. The results of the 1980 report were shocking. The Black Report found little evidence that the creation of the NHS had equalized health care access or health care outcomes at all. Here are the words of Patrick Jenkin, secretary of state for social services, in his introduction to the report: 

“It will come as a disappointment to many that over long periods since the inception of the NHS there is generally little sign of health inequalities in Britain actually diminishing, and in some cases they may be increasing. It will be seen that the Group has reached the view that the causes of health inequalities are so deep rooted that only a major and wide-ranging programme of public expenditure is capable of altering the pattern.”

In other words, 30 years after Britain had nationalized its health care system and replaced private care with public care, it appears that inequalities in access to health care and health care outcomes were not any different than if the NHS had never been established at all!

About two decades later, after politicians in both parties expressed their resolve to improve the state of affairs and vigorously pursue the original objectives of the NHS, a second study, chaired by Sir Donald Acheson (the Acheson Report) was conducted. The findings? Not only had inequalities not diminished since the publication of the Black Report, they appeared to actually have gotten worse. 

The British results are not all that unusual. In Canada, studies find that the wealthy and powerful have significantly greater access to medical specialists than less-well-connected poor people. High-profile patients enjoy more frequent services, shorter waiting times and greater choice of specialists. Moreover, among the non-elderly white population, low-income Canadians are 22% more likely to be in poor health than their U.S. counterparts.  

Note, however, that what is true in Britain and Canada is also true in other developed countries where government is heavily involved in health care delivery. For OECD countries generally, a 2008 study by health economist Sherry A. Glied found that among people with similar health conditions, “higher income people use the system more intensively and use more costly services than do lower income people.”  

Is it possible that low-income Britons and low-income Canadians might have been better off if the government had not nationalized their health care systems? Yes, that is possible. But of greater interest is to understand why inequalities persist in systems nominally dedicated to their removal. That might help us understand our own country’s response to Covid-19.

One reason is the physical distribution of health care resources. In Britain, health care access and health care outcomes are known to vary radically by postcode (the British term for the American zip code). In general, the hospitals with the largest budgets, the most modern equipment and the best doctors are located in the areas of the country where the highest-income Britons live. And that’s not an accident. Where hospital funds are spent is just as much a political decision as any other decision government makes. 

Second, higher-income Britons and Canadians are more likely to have a social relationship with their doctors. In both countries there are long waiting lists for hospital procedures. The patient who has dinner with her doctor at a country club is more likely to be able to jump the queue than a carpenter, bricklayer or other tradesman. 

Third, in Britain (but not in Canada) high-income patients are more likely to have a financial relationship with their doctors. The British system has a small but important private sector, where patients pay market prices for physician services and the doctors who practice in that sector also have National Health Service hospital privileges. Many employers even offer private health insurance to white-collar workers as an employee benefit. When patients receive their surgery, however, the doctor does it in an NHS hospital, with the NHS paying the bill. 

Finally, higher-income, better-educated people are almost always more successful at navigating bureaucratic systems. The British NHS is not like Walmart, which continuously monitors its sales in order to make sure it always has in stock whatever its customers want, when they want it. It’s more like a Department of Motor Vehicles, where the lives of employees are improved if the customers get tired of waiting and go home. Rationing by waiting is as much an obstacle to care as rationing by price. It seems that the talents and skills that allow people to earn high incomes in the economic marketplace are similar to the talents and skills that are useful in successfully circumventing bureaucratically managed waiting lines.

Bottom line: Decades of experience with non-price rationing of health care in countries with cultures very similar to our own provides a ton of evidence that the poor, racial minorities and other marginalized groups rarely make it to the front of the waiting lines.

But what is the alternative? John Cochrane has an excellent post explaining why price rationing is a superior way of distributing vaccines in almost every dimension. Wouldn’t that put the poor at a disadvantage? If it does, we could subsidize their purchases. But even if we don’t do that, studies show that non-market barriers to care (mainly the time cost of care) are a greater deterrent than market barriers (mainly prices) in impeding access to care for low-income families.

https://www.forbes.com/sites/johngoodman/2021/03/03/who-is-getting-the-vaccine-who-isnt-and-why

Vaccines and Rare Clotting Disorders: What's the Link?

 The possibility of a blood clot is not usually on the minds of most people when they roll up their sleeves for a vaccine, but lately that issue has been on the radar.

Recently, vaccinations with the AstraZeneca COVID-19 shot were put on hold in countries across Europe following reports of rare blood clots, low platelets, and hemorrhage. After formal review, the European Medicines Agency (EMA) and World Health Organization (WHO) both issued statements saying that the overall risk for clotting with this vaccine is no higher than in the general population, that the benefits outweigh the risks, and that vaccinations should continue. The American Society of Hematology has also said that the benefits of the AstraZeneca vaccine outweigh clotting risk.

The AstraZeneca COVID Vaccine

The EMA and WHO reviewed 18 cases of cerebral venous sinus thrombosis (CVST) following administration of over 20 million doses of the AstraZeneca vaccine. Almost all of these events happened in women under age 55. CVST refers to clots forming in veins that drain the brain, which can lead to hemorrhage and stroke. It is very rare, and normally affects about 5 people in 1 million per year.

"CVST is one of those low frequency, high morbidity conditions that attracts attention," said Rajiv Pruthi, MBBS, a hematologist at the Mayo Clinic in Rochester, Minnesota.

In its statement, the EMA said that "some concerns" remain for rare cases of specific thromboses in younger people, and that the vaccine product information should be updated to include the possibility that rare, specific thromboses may occur up to 16 days after vaccination. Both WHO and the EMA have said that further investigation is warranted.

In AstraZeneca's announcement of topline interim results from its U.S. trial, the company said it looked specifically for CVST cases among participants and there were none. About 32,500 people were in the trial, including more than 20,000 receiving the vaccine.

Clots in the U.S.

In the U.S., a Miami physician died following complications of immune thrombocytopenic purpura (ITP) after his first dose of the Pfizer COVID-19 vaccine. ITP is a rare autoimmune condition in which the body generates autoantibodies to its own platelets, resulting in low platelet counts, blood clots, and bleeding if the platelet count drops very low. About 50,000 adults are diagnosed with ITP in the U.S. per year. Risk is increased in young women and people with other autoimmune conditions.

In a case series, James Bussel, MD, and colleagues reviewed 20 reports of thrombocytopenia after receipt of the Pfizer and Moderna COVID-19 vaccines in the U.S. Bussel is professor emeritus of pediatrics at Weill Cornell Medical College in New York City who has published extensively on ITP. His group found that 17 of these patients did not have pre-existing thrombocytopenia. Patients' median age was 41 and 11 were women.

"It is not surprising that 17 possible de novo cases would be detected among the well over 20 million people who have received at least one dose of these two vaccines in the United States as of February 2, 2021," they wrote in the American Journal of Hematology. "The incidence of an immune‐mediated thrombocytopenia post SARS‐CoV‐2 vaccination appears either less than or roughly comparable to what would be seen if the cases were coincidental following vaccination, perhaps enhanced somewhat by heightened surveillance of symptomatic patients."

However, they note that "all but one" of these cases occurred after the first dose of the Pfizer or Moderna vaccine.

"One would assume that if the vaccination was unrelated to development of ITP, case occurrences would divide more evenly between the two doses," they write. "...[W]e cannot exclude the possibility that the Pfizer and Moderna vaccines have the potential to trigger de novo ITP (including clinically undiagnosed cases), albeit very rarely."

Clots After Other Vaccines

ITP has been reported after natural infection with viruses like HIV and hepatitis C. As well, "ITP has been reported after other vaccines, albeit not at high enough numbers to warrant concern," Alfred Lee, MD, PhD, a hematologist and associate professor of medicine at Yale School of Medicine told MedPage Today.

Much of the information about ITP and vaccines relies on small numbers of case reports. The condition has been reported in about 1 to 3 children out of every 100,000 after receiving the MMR vaccine, a rate that is significantly lower than reported after natural infection with these viruses, according to one review. Other cases of ITP -- mostly mild -- have been reported after vaccination for flu, varicella-zoster, and hepatitis B, as well as with the diphtheria/tetanus/pertussis (DTP), diphtheria/tetanus/acellular pertussis (DTaP), and Shingrix zoster vaccines.

It's important to remember that rare adverse events like these rely on voluntary reporting to the CDC's Vaccine Adverse Event Reporting System, which could be biased. The key is to look at the observed incidence following the vaccine compared to the expected incidence in the general population, according to the Mayo Clinic's Pruthi.

"Severe autoimmune thrombocytopenia is really rare," he said.

What's Going On?

Still, scientists are generating hypotheses.

For cases of CVST linked to the AstraZeneca vaccine in Europe, the leading hypothesis is that these few patients may be experiencing an autoimmune reaction. Two teams of researchers in Germany and Norway said they had identified an autoantibody called heparin platelet factor 4 antibody that may be involved in CVST's development. The group, which includes Andreas Greinacher, MD, of the Medical University of Greifswald in Germany, who is well known in the field, issued a statement about their preliminary data (though no formal publication or preprint manuscript). The statement offers guidance on diagnosing and treating this condition if it develops after the AstraZeneca vaccine.

Heparin platelet 4 antibody causes heparin-induced thrombocytopenia (HIT), in which heparin paradoxically activates platelets, leading to platelet depletion and clotting. HIT is a well-known but rare complication of heparin use that develops in about 1%-2% of patients. Some patients who have never been exposed to heparin can also have this autoantibody.

Moreover, this antibody has been linked previously to rare cases of CVST -- about 20 have been reported in the literature, according to Pruthi.

"This is a unique situation because the German and Norwegian researchers actually found a unique antibody for which there's no other explanation than the vaccine," he said. "Although the observed incidence of CVST with the AstraZeneca vaccine does not appear to be higher than expected in the population, I think this deserves further study."

Are the European and U.S. Cases Linked?

Whether these rare clotting events in Europe and the ITP cases in the U.S. bear anything in common is anyone's guess right now.

One hypothesis is that the mRNA vaccines (Pfizer, Moderna) and those using adenoviruses (AstraZeneca, Johnson & Johnson) could induce synthesis of the COVID spike protein within platelets, which may then trigger autoimmune reactions against platelets, Hamid Merchant, PhD, of the University of Huddersfield in England, wrote in a letter to The BMJ.

"COVID genetic vaccines may have a direct role in spurring an autoimmune response against platelets that may clinically manifest in thrombocytopenia, hemorrhage, and blood clots. Clotting risks may be equally possible with all genetic COVID vaccines, and may not be limited only with the AstraZeneca/Oxford vaccine," he told MedPage Today.

Pruthi said ITP related to vaccination is probably a separate process involving a different autoantibody than the HIT reaction linked to the European CVST cases. The important point is that healthcare providers recognize the possibility that platelet factor 4 antibody could be involved in very rare cases of CVST after vaccination for COVID-19.

"Generally when patients develop CVST, the first thing you do is give them heparin. In this situation, that would be the worst thing to do. You would need to avoid heparin and use a different nonheparin anticoagulant," he said. "Hence the importance of making the diagnosis. Providers need to be vigilant to this phenomenon, to make sure they get the right tests, diagnose it quickly, and consult a coagulation expert."

https://www.medpagetoday.com/special-reports/exclusives/91813

Revolution Underway in Alzheimer's: Not All Good

 The biomarker revolution has changed the way people look at Alzheimer's disease -- and that has its downsides, says Jason Karlawish, MD, co-director of the Penn Memory Center at the University of Pennsylvania in Philadelphia.

"Over a fairly short period of time, we've had a revolutionary redefinition about what we talk about when we talk about Alzheimer's," Karlawish said in an interview with MedPage Today. "This is really made possible by two events: one is the discovery of biomarkers, and the other is the discovery of the idea of mild cognitive impairment."

In the field of Alzheimer's disease, science often collides with politics. Battle lines are drawn over cure versus care. More than six million Americans live with Alzheimer's, and many more provide unpaid care for patients. And decades after scientists first realized they could clear the brain of amyloid plaques -- a hallmark of the disease, along with tau tangles -- people with Alzheimer's have no effective treatments.

This is the backdrop for Karlawish's new book, The Problem of Alzheimer's: How Science, Culture, and Politics Turned a Rare Disease Into a Crisis and What We Can Do About It. MedPage Today senior staff writer Judy George spoke with Karlawish to learn more about the complexity of Alzheimer's disease in today's society.

George: Let's start with the biomarker revolution. We now can image amyloid and tau in people's brains, and blood tests for Alzheimer's are on the horizon.

Karlawish: When I started out, patients had to have dementia to be diagnosed with Alzheimer's. It was a sort of Gothic horror story; I couldn't tell you what was wrong with you until you died and until then, it was at most a probable diagnosis.

Biomarkers have made what was invisible visible. But the biomarker revolution will not be without challenges. One is the pushing of the Alzheimer's diagnosis into milder and milder and even unimpaired states of being -- persons who are not impaired, or at most are mildly cognitively impaired.

This certainly creates opportunities for early diagnosis and treatment. But it presents real challenges to people in terms of their identity, autonomy, and threats that come from stigma and the need for monitoring and therefore intrusion into their privacy.

George: What kind of stigma?

Karlawish: There are three kinds of stigma with Alzheimer's disease. There's self stigma -- the stigma an individual feels when they can't do things. There's public stigma -- the world around them thinks less of them. And there's stigma that people around the patient or family members may feel, a distancing from others.

I cite a story in the book about Ronald Reagan. His ambassador to the White House and the U.K., Walter Annenberg, was quoted as saying that he preferred to remember Reagan as a vigorous fellow. He didn't want to see him with Alzheimer's because he was just "out of it." He was essentially saying, "I'm staying away from Ronald Reagan, I'm distancing myself from him," which meant he was distancing himself from Nancy Reagan as well, I assume. To me, that is a very poignant example of stigma.

The ground zero of stigma expression in Alzheimer's disease is what I call the "z" word -- namely, that we cultivate this rhetoric of death before death or the living dead, that people become zombies.

George: You've mentioned the Alzheimer's field has an "odd pitting of care versus cure." How did this emerge?

Karlawish: It's wrapped up in a number of events. The Alzheimer's field struggled to gain legitimacy, and focusing on topics other than "let's figure out how to diagnose and cure this disease" was perceived as a distraction from that mission.

When the Alzheimer's Association was founded in 1980, there was no debate that cancer was a disease; cancer had been recognized for centuries. There was no debate that cardiovascular disease was a disease. Yet in 1980, there was vast ignorance about the legitimacy of Alzheimer's as a disease.

We support research to discover a cure, but we don't agree on how to care for people with Alzheimer's disease. Care has become caught up in contentious political debates around the role of the state for long-term care services and support and ideological battles about the role of the family.

In the 1990s, one party in America said absolutely no increases in taxes, no expansion of federal programs beyond defense and some related things, and had a deep skepticism about feminism and creating equal opportunity for women. While none of those positions were articulated to specifically harm or otherwise hurt persons living with dementia or their caregivers, they did just that because they thwarted a coherent national conversation about how we should provide care.

You have to build infrastructure for care -- for long-term services and support, not just diagnosis and treatment. I consider it basic infrastructure that allows the American family to function, like roads and traffic lights: we don't question those as being what we need.

George: The FDA will decide the fate of aducanumab soon. What can we expect from drugs like aducanumab?

Karlawish: Aducanumab is part of the story of amyloid, which is interesting. Right around the turn of the century, studies first appeared using a very novel method that cleared transgenic mice of amyloid. Researchers were thinking they might have to find a new line of work because Alzheimer's would be solved.

Well, here we are 21 years later and it's not solved, and at best we have a treatment that's controversial. Even the most optimistic take on aducanumab is that the drug has some effect on slowing the rate of progression.

A word that's whispered at meetings is "heterogeneity" -- that we really should think of this not so much as Alzheimer's disease, but Alzheimer's diseases. I think a very plausible future is that there will be druggable forms, not so-druggable forms, and potentially untreatable forms of Alzheimer's. The stories of multiple sclerosis tell us that; the stories of many cancers tell us that.

The implication is we really need to think about how we're going to live with this disease. We're not going to drug our way out of the problem. Banking on a cure for all causes of late-life disabling cognitive impairments is like planning your retirement with lottery tickets: you may win and win big, but odds are you're not going to.

George: Given Alzheimer's many dimensions, what do we need to pay attention to next?

Karlawish: We're beginning to face an enormous irony in the field of Alzheimer's. The reason why Alzheimer's is a disease is because of its relentless assault on our autonomy and self-determination. Alzheimer's keeps people from living their life the way they want to live their life. That's what makes it a disease, fully, completely -- along with amyloid, tau, and neurodegeneration.

The irony is that the biomarker transformation poses threats to the very same autonomy we're trying to preserve. We can address those threats, but we have to organize ourselves as a society to do that.

Our approach to dealing with this disease needs to emphasize helping persons living with it to maintain autonomy and identity, even in the face of disabling cognitive impairments.

That needs to be the way we frame our strategy as a country in terms of the support we provide people, the way we talk about the disease, and the language and images we use.

https://www.medpagetoday.com/neurology/alzheimersdisease/91927

1/5 in US Give to Medical Crowdfunding Campaigns

 Despite the financial hardships that many Americans experienced during the COVID-19 pandemic, 45 million still donated to medical crowdfunding campaigns last year, survey results suggested.

Among more 1,000 members of a population-representative panel, 18% reported donating to a crowdfunding campaign raising money for a medical bill or treatment, reported Susan Cahn, DrPH, and Mollie Hertel, AM, MPP, of the National Opinion Research Center (NORC) at the University of Chicago.

The average number of donations per donor was about 1.4; 28% of donors contributed to two or more efforts.

Nearly 40% of people who donated to a medical crowdfunding campaign were from households with annual income less than $60,000. Of those who donated, 36% were not working (either unemployed or retired) and 6% had no health insurance at the time the survey was taken.

Among individuals who contributed funds to medical crowdfunding, 52% reported donating to raise money for a friend. Around 30% donated to someone they didn't know personally, 22% donated to an acquaintance, 14% donated to a relative, and 8% donated to a co-worker.

"This demonstrates that even during the pandemic, Americans continued to try to help their friends, families, and strangers pay for medical care and treatment," Cahn told MedPage Today. Cahn added that continued trends of medical crowdfunding donations across the last year was striking, as many people were faced with financial challenges including paying for their own medical expenses and losing access to insurance.

Many people have turned to crowdfunding campaigns to help them afford rising out-of-pocket medical costs, via websites such as Indiegogo, Kickstarter, and GoFundMe. In 2019, the CEO of GoFundMe said one-third of all donations to the site were for medical expenses.

Survey results from NORC last year showed nearly identical participation in medical crowdfunding. While the researchers expected that figure to fluctuate during the pandemic due to financial challenges, that metric remained consistent.

For the current report, surveyors interviewed 1,028 members of NORC's AmeriSpeak probability-based panel. All of the survey respondents were interviewed in December 2020, were 18 years or older, and spoke English.

Cancer was the most common condition for which people supported crowdfunding campaigns, with 39% donating funds to this cause. Additionally, 35% contributed to expenses for accidents or workplace injuries, 19% for heart disease, and 11% for mental illnesses such as depression, bipolar disorder, or schizophrenia.

Among those who started a medical crowdfunding campaign, nearly one-third sought to raise money for someone with COVID-19. Approximately 21% of people who started a campaign did so for accidents and injuries, 20% for cancer, and 10% for diabetes. The report gave no estimates for dollar amounts donated, however, either overall or for specific conditions or types of expenses.

Cahn said that while crowdfunding is not a systemic solution to unaffordable healthcare, it's popular because "Americans know that there are gaps in insurance and people have really significant needs."

"While Americans continue to donate to help friends and family and strangers, they think that the government and healthcare providers have a great deal of responsibility to deal with healthcare affordability," she said.

https://www.medpagetoday.com/special-reports/exclusives/91925

New State-by-State Reports Reveal Huge Human, Economic Toll of Osteoporosis

 A new series of state-by-state reports released today by the National Osteoporosis Foundation (NOF) highlights substantial differences across the states in the number of fractures caused by osteoporosis and their resulting costs and deaths. The reports also document racial disparities in screening and outcomes, including lower screening rates and higher rates of death for Black Medicare FFS beneficiaries following a bone fracture.

The NOF contracted with the independent actuarial firm Milliman to analyze the state-by-state economic and clinical impact of bone fractures suffered by Americans insured by Medicare. The 50 individual state reports being released today provide a first-ever detailed state-level review of the incidence of osteoporotic fractures, their health care impact and associated Medicare costs.

Key findings include:

• Approximately 2.1 million osteoporotic fractures were suffered by 1.8 million Americans covered by Medicare in 2016. The incremental annual allowed medical cost for osteoporotic fractures was $21,564 per Medicare FFS beneficiary in 2016.  
• Medicare FFS beneficiaries suffered additional subsequent fractures within one year of the initial fracture at over three times the annual rate of new osteoporotic fractures for all Medicare FFS beneficiaries. In the six-month period following subsequent fractures that were suffered up to three years following an initial fracture in 2016 the cost was $5.7 billion. 
• Preventing between 5% and 20% of these subsequent fractures could have saved between $272 million and $1.1 billion for the Medicare FFS program during a follow-up period that lasted up to three years after a new osteoporotic fracture.

State Variations:

• After adjusting for differences in age and sex, Medicare FFS beneficiaries in Hawaii had 24% lower rates of osteoporotic fractures than the national average, while Kentucky and Florida had the highest rates of fractures, 13% and 12% higher than the national average respectively.   
• While the national average estimated 180-day incremental cost of a subsequent fracture was about  $20,400, this varied significantly among states from a low of about $17,000 in Arkansas to a high of $26,200 in Wyoming.

Ethnic/Race Variations:

• While Black Medicare FFS beneficiaries had lower rates of fracture, only 5% received screening for osteoporosis with a bone mineral density (BMD) test within 6 months of a new osteoporotic fracture – when the need for treatment and action is highest – compared to 8% of all Medicare FFS beneficiaries with a fracture.
• 22% of Black Medicare FFS beneficiaries died within 12 months of a fracture, exceeding the national average rate of 19% and rates for White (19%), Asian (16%), Hispanic (18%) and North American Native (18%) beneficiaries.   
• About 6% and 7% of North American Native and Hispanic Medicare FFS beneficiaries, respectively, received a BMD test within 6 months of a new fracture compared to 8% among all Medicare FFS beneficiaries.

"The health care system is failing the more than 54 million people who have osteoporosis or low bone density and are at high risk of breaking bones," said Claire Gill, CEO of NOF. "We have the tools to substantially reduce the enormous burden of osteoporotic fractures, and there are simple steps the Biden Administration and Congress can take to incentivize their use."

The NOF made several recommendations based on the report, including:

• Congress and CMS should make changes to Medicare payments to incentivize widespread use of model secondary fracture prevention/care coordination practices for beneficiaries who have suffered an osteoporosis-related fracture and are thus at risk for another fracture.
• Cuts to Medicare payment rates for osteoporosis screening which have reduced access should be reversed either administratively or by legislation.
• Medicare also pays for FDA-approved drug treatments for osteoporosis that can help reduce spine and hip fractures by up to 70 percent and cut secondary (repeat) fractures by about half. But about 80 percent go untreated, even after a fracture. Congress should mandate and fund a national education and action initiative aimed at reducing fractures among older Americans.

Pamela Pelizzari, a Milliman co-author, said, "The findings in this report highlight the substantial disease burden resulting from osteoporosis-related fractures among Medicare FFS beneficiaries. The state-level reports highlight both variability across populations and opportunities for improvements in osteoporosis management."

For a full copy of the report, please visit NOF's National Bone Health Policy Institute website: https://www.bonehealthpolicyinstitute.org/

https://www.biospace.com/article/releases/new-state-by-state-reports-reveal-the-huge-human-and-economic-toll-of-osteoporosis/

AMA unit Health2047 spins out obesity testing startup to speed personalized medicine

 The American Medical Association innovation subsidiary Health2047 has spun off a company that uses personalized medicine to fight obesity.

Phenomix Sciences is a phenotype testing company that carries out the AMA’s mission to confront chronic diseases such as obesity.

Phenomix uses a blood test called MyPhenome that it has licensed from the Mayo Clinic to allow doctors to prescribe individualized therapies. MyPhenome measures DNA as well as a person’s metabolites and hormones. These biomarkers make up a person’s phenotype, according to Phenomix.

A 2020 Columbia University study found that 60% of people who were extremely obese were more likely to require ventilation or pass away from COVID-19. Overall, 42% of American adults live with obesity, according to a report by Trust for America’s Health, which also incorporated data from the Centers for Disease Control and Prevention.

The company’s blood-based test uses phenotype-driven multi-omics technology to predict responses to obesity interventions that the Food and Drug Administration (FDA) has approved. A multi-omics test is important because testing for obesity involves multiple factors, including genetics, metabolomics and environmental aspects, according to Phenomix CEO Mark Bagnall.

“Properly identifying obesity phenotypes requires more sophisticated testing than a simple genetic or DNA test,” Bagnall told Fierce Healthcare.

In 2018, the AMA announced a $27.2 million investment in Health2047. At the time, Health2047 planned to use the funds to commercialize its products and develop the company around chronic disease reduction, productivity and value-based care. Now Phenomix will commercialize its AI-powered multi-omics biomarker. according to the company’s co-founder and physician-scientist Andres Acosta.

“This technology could help more than a billion people in the world currently struggling with excess weight,” Acosta told Fierce Healthcare. “Thus, it was essential to spin out this technology to accelerate its commercialization and help overweight people and those with obesity.”

Because patients respond differently to obesity treatment, the Phenomix founders turned to AI to personalize this treatment. AI can personalize a multi-omics obesity test and analyze single-nucleotide polymorphisms, metabolites and hormones that correspond with a certain obesity phenotype, according to Bagnall.

AI can help identify a specific obesity phenotype so patients can receive the right treatment.

“[We] demonstrated in several clinical studies that knowing a patient’s phenotype doubles the likelihood of weight loss and doubles the amount of weight lost,” Bagnall said.  

Since it was launched in 2016, Health2047 has spun out several other companies, including First Mile Care, a company that created a platform to reverse prediabetes, and Akiri, a secure network-as-a-service company that facilitates health data sharing in real-time.

Another company that Health2047 launched, Zing Health, aids doctors and communities in coordinating care for chronically underserved populations. Meanwhile, Medcurio enables healthcare organizations to gain value from healthcare data and protects data privacy.

A 2019 survey of healthcare executives by KLAS Research and the Center for Connected Medicine (CCM) revealed that healthcare organizations have been slow to adopt precision medicine, which focuses on precise treatment for groups. CIOs interviewed for the report cited limited funding and a lack of reimbursement from payers as factors holding back precision medicine.

Bagnall says the work in personalized medicine for people with obesity will lead to treatments for other chronic diseases. AI and multi-omic tests can make this possible.

“In chronic disease, where environmental factors play a large part, the analysis of the underlying condition is more complex, thus requiring new tools like AI and multi-omics,” he said. ”As Phenomix’s approach to personalized medicine improves outcomes for patients with obesity, we expect these tools to be used in the treatment of other chronic diseases.”

https://www.fiercehealthcare.com/tech/ama-unit-health2047-spins-out-obesity-testing-startup-to-accelerate-personalized-medicine

Law enforcement scrutinizing CARES Act Provider Relief Fund Uninsured Program

 The Department of Health and Human Services appears to have begun conducting an outlier analysis on its reimbursement to healthcare providers for treating uninsured COVID-19 patients. Providers have who have received payments from the COVID-19 Uninsured Program should take steps to ensure that they are in full compliance with the terms and conditions for payment, including the balance billing restriction.

On March 27, 2020, the Coronavirus Aid, Relief and Economic Security (CARES) Act appropriated $100 billion to HHS to issue pandemic relief payments to healthcare providers. Using this funding, supplemented with additional appropriations, HHS created a program to reimburse providers for treatment of uninsured COVID-19 patients and COVID-19 testing and vaccination for uninsured individuals. 

According to a public database last updated on March 25, 2021, the COVID-19 Uninsured Program, which is implemented by the Health Resources & Services Administration, has distributed over $2.2 billion in reimbursement to healthcare providers for COVID-19 treatment, on top of payments for testing and administering vaccines.  

Each payment from the COVID-19 Uninsured Program is governed by a set of terms and conditions. By applying for, receiving, and retaining payments, HRSA expects each recipient to be in “ongoing compliance with these terms and conditions.” Furthermore, the terms and conditions state that each recipient’s “full compliance with all Terms and Conditions is material to the Secretary’s decision to disburse funds to the Recipient.”

The term “material” mirrors an element of many False Claims Act theories of liability and strengthens the government’s position that even discrete violations of the Terms and Conditions can serve as the predicate for a False Claims Act case. This is also consistent with public remarks from senior Department of Justice officials that “going forward the False Claims Act will play a central role in the Department’s pursuit of COVID-19 related fraud.”

So far, there has been little publicly announced scrutiny by either HHS or law enforcement of the COVID-19 Uninsured Program, despite DOJ making clear through repeated announcements—including an update on March 26 “on criminal and civil enforcement efforts to combat COVID-19 related fraud”—that it is prioritizing fraud on pandemic relief programs. And while HRSA has announced reporting requirements for General and Targeted Distributions from the CARES Act Provider Relief Fund, the Uninsured Program is not included in these reporting requirements, seemingly creating a lack of auditing visibility for the government. 

But HHS officials recently announced that they had referred to the HHS Office of Inspector General a provider that is an outlier on reimbursement for treatment claims from the COVID-19 Uninsured Program. This dovetails with a recent DOJ commitment that the “Civil Division is working closely with various Inspector Generals and other agency stakeholders to identify, monitor, and investigate the misuse of critical pandemic relief monies, and we expect this collaborative effort to translate into significant cases and recoveries.”

HHS’ announcement underscores the importance for providers that have received significant aggregate reimbursement from the COVID-19 Uninsured Program—whether for testing, treatment, or vaccination—to assess their data for outliers. 

Proactive internal data analytics are particularly important because both DOJ Civil and Criminal Division leadership have recently acknowledged a new reliance on data analytics to identify targets for investigation, explaining that they have “increasingly been undertaking sophisticated analyses of Medicare data to uncover potential fraud schemes that have not been identified by whistleblower suits, as well as to help analyze and support the allegations that we do receive from such suits.” HRSA’s payment database appears ripe for DOJ and whistleblower scrutiny, and a year into the COVID-19 Uninsured Program, DOJ may finally be turning its new analytical skills on this reimbursement information.   

Providers can assess outlier status on an array of metrics, which can vary based on provider type and structure.  Of course, situational factors such as the percentage of the population that is uninsured in the region must be taken into account while assessing outlier status. After identifying outliers, providers can perform targeted medical record reviews to assess whether documentation supports compliance with HRSA’s billing requirements.

Depending on the results, self-disclosure and administrative repayment to HRSA may be appropriate.

Providers should also ensure they have policies and procedures in place to drive compliance with ancillary provisions of the Terms and Conditions. For example, the Terms and Conditions impose a commitment that providers “not engage in ‘balance billing’ or charge any type of cost-sharing for any items or services” provided to uninsured individuals for whom the provider received reimbursement for administering a COVID-19 vaccine or treatment.

The same requirement applies to reimbursement for testing and permissible related services. Many providers may be in the process of updating their billing procedures to come into compliance with the new balance billing prohibitions imposed by the No Surprises Act, signed into law as part of the Consolidated Appropriations Act of 2021. However, particularly during the early chaos of the pandemic, providers may not have had billing safeguards in place to avoid balance billing where required by the Terms and Conditions.

HHS’ announcement serves as a signal that as the COVID-19 Uninsured Program has matured, HRSA may now be in a position to more actively work with HHS-OIG and DOJ to scrutinize provider compliance with the Terms and Conditions. Providers should ensure their compliance programs have a line of sight into reimbursement from the COVID-19 Uninsured Program.

Brenna Jenny is a partner in the Healthcare practice at Sidley Austin LLP. This article has been prepared for informational purposes only and does not constitute legal advice. This information is not intended to create, and the receipt of it, does not constitute a lawyer-client relationship. Readers should not act upon this without seeking advice from professional advisers. The content therein does not reflect the views of the firm.

https://www.fiercehealthcare.com/finance/industry-voices-law-enforcement-scrutiny-cares-act-provider-relief-fund-uninsured-program