The owner of two pharmacies and a management company in Florida pleaded guilty Jan. 25 to his role in a $931 million healthcare fraud scheme. He is the seventh defendant to plead guilty in the scheme, according to the U.S. Justice Department.
Larry Smith pleaded guilty to conspiracy to commit healthcare fraud, and his sentencing is set for Oct. 25. In his written plea agreement, Mr. Smith admitted to conspiring with others to defraud pharmacy benefit managers into paying for fraudulent prescriptions. As part of the plea agreement, Mr. Smith agreed to pay restitution of $24.9 million and forfeit approximately $3.1 million.
An indictment charged Mr. Smith and others with a nationwide conspiracy to defraud pharmacy benefit managers by submitting $931.4 million in bills for fraudulent prescriptions purchased from a telemarketing company. After improperly soliciting patient information, the marketing companies received approvals through telemedicine prescribers then sold the prescriptions to pharmacies in exchange for kickbacks, said Derrick Jackson, special agent in charge at HHS’ Office of Inspector General in Atlanta.
In September 2018, HealthRight, a telemedicine company, and its CEO Scott Roix pleaded guilty to conspiracy to commit healthcare fraud for their roles in the scheme. They agreed to pay $5 million in restitution. Mr. Roix’s sentencing is scheduled for Oct. 25.
Mihir Taneja, Arun Kapoor, Maikel Bolos and Sterling-Knight Pharmaceuticals also pleaded guilty in December 2020, according to the Justice Department.
President Biden is scheduled to take executive actions as early as Thursday to reopen federal marketplaces selling Affordable Care Act health plans and to lower recent barriers to joining Medicaid.
The orders will be Biden’s first steps since taking office to help Americans gain health insurance, a prominent campaign goal that has assumed escalating significance as the pandemic has dramatized the need for affordable health care — and deprived millions of Americans coverage as they have lost jobs in the economic fallout.
Under one order, HealthCare.gov, the online insurance marketplace for Americans who cannot get affordable coverage through their jobs, will swiftly reopen for at least a few months, according to several individuals inside and outside the administration familiar with the plans. Ordinarily, signing up for such coverage is tightly restricted outside a six-week period late each year.
Another part of Biden’s scheduled actions, the individuals said, is intended to reverse Trump-era changes to Medicaid that critics say damaged Americans’ access to the safety-net insurance. It is unclear whether Biden’s order will undo a Trump-era rule allowing states to impose work requirements, or simply direct federal health officials to review rules to make sure they expand coverage to the program that insures about 70 million low-income people in the United States.
The actions are part of a series of rapid executive orders the president is issuing in his initial days in office to demonstrate he intends to steer the machinery of government in a direction far different from that of his predecessor.
Biden has been saying for many months that helping people get insurance is a crucial federal responsibility. Yet until the actions planned for this week, he has not yet focused on this broader objective, shining a spotlight instead on trying to expand vaccinations and other federal responses to the pandemic.
The most ambitious parts of Biden’s campaign health-care platform would require Congress to provide consent and money. Those include creating a government insurance option alongside the ACA health plans sold by private insurers, and helping poor residents afford ACA coverage if they live in about a dozen states that have not expanded their Medicaid programs under the decade-old health law.
A White House spokesman declined to discuss the plans. Two HHS officials, speaking on the condition of anonymity about an event the White House has not announced, said Monday they were anticipating that the event would be held on Thursday.
According to a document obtained by The Washington Post, the president also intends to sign an order rescinding the so-called Mexico City rule, which compels nonprofits in other countries that receive federal family planning aid to promise not to perform or encourage abortions. Biden advisers last week previewed an end to this rule, which for decades has reappeared when Republicans occupied the White House and vanished under Democratic presidents.
The document also says Biden will disavow a multinational antiabortion declaration that the Trump administration signed three months ago.
The actions to expand insurance through the ACA and Medicaid come as the Supreme Court is considering two cases that could shape the outcome. One case is an effort to overturn rulings by lower federal courts, which have held that state rules, requiring some residents to work or prepare for jobs to qualify for Medicaid, are illegal. The other case involves an attempt to overturn the entire ACA.
According to the individuals inside and outside the administration, the order to reopen the federal insurance marketplaces will be framed in the context of the pandemic, essentially saying that anyone eligible for ACA coverage who has been harmed by the coronavirus will be allowed to sign up.
“This is absolutely in the covid age and the recession caused by covid,” said a health-care policy leader who has been in discussions with the administration. “There is financial displacement we need to address,” said this person, who spoke on the condition of anonymity to describe plans the White House has not announced.
The reopening of HealthCare.gov will be accompanied by an infusion of federal support to draw attention to the opportunity through advertising and other outreach efforts. This, too, reverses the Trump administration’s stance that supporting such outreach was wasteful. During its first two years, it slashed money for advertising and for community groups known as navigators that helped people enroll.
It is not clear whether restoring outreach will be part of Biden’s order or will be done more quietly within federal health-care agencies.
Federal rules already allow people to qualify for a special enrollment period to buy ACA health plans if their circumstances change in important ways, including losing a job. But such exceptions require people to seek permission individually, and many are unaware they can do so. Trump health officials also tightened the rules for qualifying for special enrollment.
In contrast, Biden is expected to open enrollment without anyone needing to seek permission, said Eliot Fishman, senior director of health policy for Families USA, a consumer health-advocacy group.
In the early days of the pandemic, the health insurance industry and congressional Democrats urged the Trump administration to reopen HealthCare.gov, the online federal ACA enrollment system on which three dozen states rely, to give more people the opportunity to sign up. At the end of March, Trump health officials decided against that.
During the most recent enrollment period, ending the middle of last month, nearly 8.3 million people signed up for health plans in the states using HealthCare.gov. The figure is about the same as the previous year, even though it includes two fewer states, which began operating their own marketplaces.
Leaders of groups helping with enrollment around the country said they were approached for help this last time by many people who had lost jobs or income because of the pandemic.
The order involving Medicaid is designed to alter course on experiments — known as “waivers” — that allow states to get federal permission to run their Medicaid programs in nontraditional ways. The work requirements, blocked so far by federal courts, are one of those experiments. Another was an announcement a year ago by Seema Verma, the Trump administration’s administrator of the Centers for Medicare and Medicaid Services, that states could apply for a fundamental change to the program, favored by conservatives, that would cap its funding, rather than operating as an entitlement program with federal money rising and falling with the number of people covered.
“You could think about it as announcing a war against the war on Medicaid,” said Katherine Hempstead, a senior policy adviser at the Robert Wood Johnson Foundation.
Dan Mendelson, founder of Avalere Health, a consulting firm, said Biden’s initial steps to broaden insurance match his campaign position that the United States does not need to switch to a system of single-payer insurance favored by more liberal Democrats.
The orders the president will sign “are going to do it through the existing programs,” Mendelson said.
A key part of President Biden’s new coronavirus strategy is a push to administer 100 million doses in 100 days, or a lofty sounding 1 million immunizations a day.
That goal, part of a comprehensive national plan launched this week, has raised questions about how quickly the United States can, and should aim to, deliver vaccines to its population.
The strategy document calls the 1 million shots per day pace “aggressive,” an effort that will “take every American doing their part.” But critics have pointed out that it does not constitute a major leap from the current rate, which has already neared or even surpassed the target. Many wonder why the country cannot move more swiftly.
It remains possible that the United States could pick up its pace as vaccine supply increases and logistics improve. But in international context 1 million doses a day does not seem slow.
Though differences in population, logistical capacity and data transparency, along with different levels of vaccine vetting and effectiveness between vaccine types, make it hard to compare vaccination campaigns across countries, the United States is near the top of the pack, behind some of the fastest countries to vaccinate, including Israel and Britain, but ahead of most of the rest of the world.
The biggest factor shaping the rate of vaccination is global supply.
Though the development and emergency approval of coronavirus vaccines has unfolded at an unprecedented pace, drug companies are scrambling to make enough doses to meet demand. As some countries receive a high number of doses from among the limited total produced, others must wait their turn.
So far, a small number of relatively rich countries, including the United States, have snapped up the initial supply, relegating low- and middle-income countries to the back of the line — possibly for years. Some projections suggest poor countries will not have enough doses until 2023 or 2024.
Rich countries are set to fare better. The European Commission aims to vaccinate 70 percent of the adult population of the European Union by the summer, though details of that plan are not yet clear.
Anthony S. Fauci, adviser to President Biden and director of the National Institute of Allergy and Infectious Diseases, said this week that the United States could potentially reach “herd immunity” by fall 2021.
Will other large countries move faster than the United States?
Possibly, but it is hard to say.
Questions about manufacturing capacity, the potential approval of additional vaccines and the impact of the new U.K. variant make predictions tough. However, India offers an interesting point of comparison.
On Jan. 16, India launched a plan to vaccinate 300 million people by August.
The roughly 200 day push to deliver 600 million doses is more ambitious than the U.S. plan. However, India’s population is more than three times larger than that of the United States.
China promised to vaccinate some 50 million people against the coronavirus before the Lunar New Year holiday next month — a seemingly rapid pace. But a report in a news outlet controlled by the ruling Communist Party said the country had administered 15 million doses by Jan. 20.
There are also questions about whether Chinese-made vaccines are as effective as the Moderna, Pfizer and AstraZeneca formulations used elsewhere.
Days after Brazilian officials announced that a vaccine made by Chinese company Sinovac was 78 percent effective protecting against moderate and severe covid-19 cases, for instance, they were forced to clarify that the shot’s efficacy rate among all cases was only 50.4 percent.
Ultimately, the biggest difference between the U.S. vaccination push and the Chinese effort is need.
Though there are doubts about China’s figures, the country reports just above 4,600 coronavirus deaths to date — comparable to the 4,409 U.S. deaths on Inauguration Day alone.
Vic Gara, 57, at his home in West Granby Dec. 10, 2020. Gara survived COVID-19 in a hospital ICU bed on a ventilator. Months later, he discovered he was experiencing long-term complications from the virus.
In early March, Vic Gara came down with severe muscle aches, headaches and a rising blood pressure, indicators of COVID-19 that weren’t well understood early on in the pandemic.
“Taking a shower, just the water hurt my body,” he said. “I couldn’t sleep. I slowly became hypoxic. I just couldn’t breathe.”
Eventually, he was admitted to Hartford Hospital, where he was quarantined immediately and separated from his wife, Laura.
“My wife was walking in from after parking the car, and I saw her from maybe 15, 20 feet away and I just barely raised my hand and said goodbye to her,” Gara recalled. “And I was there for a month.”
The 57-year-old was intubated and spent 11 days on a ventilator, which helped him breathe, before he regained consciousness. Like so many others who required intensive care, Gara was first transferred to a rehabilitation hospital for a short time before he could return to his home in West Granby.
He thought the worst was behind him. But by midsummer, Gara struggled with exhaustion, his headaches returned, he had poor balance and trouble speaking and “brain fog” had set in. Then he joined an online support group for COVID-19 survivors.
“Not until I was contacted did I find out, ‘Oh my god, there’s other people like me that are suffering almost identical situations,’” he said.
There is an untold number of COVID-19 survivors worldwide who struggle with long-term symptoms and complications from the virus. Scientists don’t yet know how common this occurs, but what they do know is symptoms can be both physical and mental in nature, and they can delay people from making a full recovery.
As the phenomenon becomes more well-known and researched, health organizations across Connecticut and the country are creating and expanding dedicated COVID-19 recovery programs to help survivors.
“We’re now seeing patients that have had some of those symptoms for eight, nine months,” said Dr. Jerry Kaplan, outpatient medical director at Gaylord Hospital in Wallingford. He runs the organization’s new COVID-19 recovery and rehabilitation program.
The hospital created an online support group over the summer for former COVID-19 rehab patients like Gara. Kaplan said that’s when patients came forward with a wide range of lingering health issues.
Gaylord opened its specialized outpatient program in early fall, and it provides COVID-19 survivors with occupational and physical therapies, nutrition education, psychological treatment and other services.
“Even if you can’t do everything you were doing before, we can get you to the highest possible functional level,” Kaplan said, “and that’s really what the program is designed to do.”
The program has picked up in the last several months as long-term complications from COVID-19 illness become more well-known.
“As we see more patients hospitalized with COVID now, we will continue to see the need for COVID recovery programs in the future,” Kaplan said.
The Post-COVID-19 Recovery Program at Yale Medicine opened several months ago as a Friday clinic with a small patient roster. Dr. Denyse Lutchmansingh said it has now expanded to three days a week as more patients and medical clinicians discover the program.
“I think early on, people would say, give it a couple of weeks and you should feel better,” she said. “And now we’re well past that give-it-a-couple-of-weeks period and people are still having symptoms.”
Lutchmansingh, a pulmonary and critical care physician who leads the Yale recovery program, said she and her colleagues initially expected that patients who had had moderate to severe COVID-19 illness, like Gara, would be the ones needing long-term recovery services the most.
That’s only been partly true.
“Patients who were classified as mild disease have also had persistent symptoms almost as severe as a patient who was hospitalized in an intensive care unit, and that has been quite eye-opening,” she said.
Lutchmansingh said the clinic is also seeing a surprisingly young population. She has patients in their 30s and 40s who were runners, athletically inclined, or generally in good health prior to getting a mild case of COVID-19 “who now struggle to walk up a flight of stairs.”
It’s some of these patients that Lutchmansingh has seen struggle the most mentally with their persistent symptoms.
“Because they expected to recover very quickly and move on,” she said.
Dr. Serena Spudich is the division chief of neurological infections and global neurology at Yale School of Medicine and leads a designated neuro-COVID clinic, which opened in October.
Her team collaborates with Lutchmansingh and other clinicians in the greater community to get referrals for COVID-19 survivors suffering with tingling and numbness, loss or impaired senses of smell, taste and hearing, headaches, cognitive impairment and other complications.
Many of these patients were never hospitalized or never required intensive care for COVID-19.
This is where more research can help make sense of the trends that health providers are seeing in their COVID-19 “long hauler” patients, Spudich said.
“I think it’s really important to try to understand why some people get these neurologic issues, and many people don’t seem to,” she said. “I know lots of people who’ve recovered from COVID who seem completely fine.”
Scientists are still trying to estimate exactly how many people in the world ever had COVID-19, including those who never got tested or people who got false negative results — cases that have not been recorded.
Only then might health experts know how common or rare long-term complications are among survivors, Spudich said.
“I think it’s important to be aware of them, to understand them and of course provide treatment for them,” she said. “But I worry that it’s sort of a fire that can take off where all the social media, all the press attention will suddenly make a lot of people think, ‘Oh, I’m having post-COVID problems.’”
“What is really, really important is getting patients who are having symptoms to a provider who can really critically take care of them and try to understand clinically what’s happening with them.”
What patients often want to know is, when will their health get back to what it was prior to COVID-19? And health experts don’t yet have a good answer to that as scientists continue to follow survivors in their recovery.
“We always make it clear to the patients that we don’t have all the answers. We are looking for answers,” Lutchmansingh said. “We remain hopeful, we have seen patients improve and build back to baseline, but it is a long pathway and it is not necessarily an easy pathway.”
For Gara, he continues recovery treatment at Gaylord on an outpatient basis. He tries to get outside more and build up his endurance with walks. For the most part, he takes it one day at a time.
“I went into it with an open mind and trying to stay positive,” he said. “I learned how to be more positive and look for the good rather than the bad. It helps.”