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pandemic

  • sam patrick posted an article
    Womble Bond Dickinson provide insight into telehealth during the pandemic see more

    Takeaways:

    • Telehealth greatly expanded during the COVID-19 pandemic, in large part due to regulatory waivers. Those regulatory waivers aren’t permanent, but lawmakers are evaluating ways to permanently expand some aspects of telehealth coverage. 
    • While the HHS OIG recognizes the importance that telehealth plays in our healthcare system and will continue to evaluate new telehealth policies and technologies so as to improve care, it will also strive to ensure that they are not compromised by fraud, abuse, and misuse.   
    • Through recent telehealth policies and funding, the government is working to improve healthcare equity and resources for telehealth.  

    While the COVID-19 pandemic remains a public health and economic concern, companies are adapting and adjusting, finding new and better ways to do business moving forward. Womble Bond Dickinson is taking a comprehensive look at this new Opportunity Economy from a wide range of viewpoints. Recently, Womble Bond Dickinson attorneys Alissa Fleming and Toni Peck explored the pandemic-inspired expansion of telehealth services and how such measures can benefit patients and providers alike moving forward. They recently spoke to Womble Bond Dickinson attorney Mark Henriques on an episode of the “In-house Roundhouse” podcast, and the article below is based on that conversation.

    The telehealth boom during the COVID-19 pandemic impacted nearly every American. Changes made during the public health emergency promise to permanently transform the delivery and availability of healthcare. While these changes were made in rapid response to the pandemic, providers and patients alike discovered that telehealth—providing healthcare remotely via technology—offers advantages and efficiencies that make sense to continue even as the pandemic ends.

    Healthcare is perhaps the most highly regulated sector of the economy, so extending telehealth post-pandemic will require regulatory reform as well as consumer demand. 

    The State of Telehealth in the Late-Stage Pandemic

    Telehealth isn’t a new idea. As Peck said, “Prior to the pandemic, there was an interest from providers and patients, but there were restrictions and limitations that kept telehealth from being as popular as it currently is.”

    For example, providers faced geographic restrictions for where they could serve patients. Only certain types of technology could be used. And only a limited number of telehealth services were eligible for reimbursement from Medicare, Medicaid and private payors. 

    A study published in JAMA Network Open found that telehealth services grew by 1,000 percent in March 2020 and 4,000 percent in April 2020, with in-person visits declining 23 percent and 52 percent respectively. Those numbers have evened out somewhat, Peck said, but telehealth use remains much more popular than it was pre-pandemic.

    “One of the biggest things that has changed has been patient and provider attitudes—we’re more willing to use it,” Peck said.

    Also, federal and state governments have lifted many of the previous geographic restrictions temporarily. Technology requirements have been relaxed temporarily to allow for the inclusion of Zoom, FaceTime, and other popular platforms. More services now can be reimbursed, prescription restrictions have been relaxed, and licensure requirements by state medical boards have been eased temporarily. 

    “Telehealth has been crucial in the past 18 months, especially in championing healthcare equity,” Peck said. “We are better able to reach underserved populations, including rural populations, with telemedicine.” 

    Not surprisingly, investors have taken notice. Venture capital funding for telehealth reached $15 billion in the first half of 2021, up from $6.3 billion in the first half of 2020.

    The rapid increase in telehealth adoption wouldn’t have been possible without regulatory streamlining that came in response to the public health emergency.

    “Before the pandemic, telehealth only covered about 100 service areas, primarily those serving beneficiaries in rural areas,” Fleming said. But in early 2020, the Centers for Medicare and Medicaid Services (CMS) expanded Medicare coverage by adding 140 additional services, regardless of location. This includes ER visits, occupational/physical therapy, hospital discharge day issues and other non-critical care services. Also, a much broader range of providers now may provide these services via telehealth.

    “This expansion of Medicare and Medicaid coverage helped to spawn payment for telehealth by private insurance payers,” Fleming said. “In allowing this expansion, the government acknowledged the critical role telehealth plays in expanding healthcare access.”

    What’s Next in Telehealth?

    But while telehealth has played a critical role in expanding healthcare access during the pandemic, the scope of the relaxed regulations was not intended to be permanent. So when do waivers expire and will they be continued?

    Fleming explained that currently, the waivers will stay in effect through the end of the public health emergency or the end of the year. “With the Delta surge and the additional challenges that have come this summer and fall, there has been no further extension of the timetable, but that’s not to say there won’t be,” she said.

    Such an extension may have a broad base of support, but it won’t necessarily happen automatically or without additional change. 

    Over the past several years, federal regulators have scrutinized telehealth arrangements, with a particular concern about fraud and abuse. The pandemic waivers reduced red tape, but federal regulators remain concerned about potential fraud and abuse issues. 

    “It’s not as easy as we might hope to permanently remove some of the regulatory requirements relaxed during the pandemic,” Fleming said. “Depending on the regulatory concerns, we may not see it expanded on such a broad base as we are seeing during the public health emergency.”

    Peck also noted that some waiver expansions will require Congressional action, not just administrative changes. 

    States also will play a role in the continued, permanent expansion of healthcare. Generally, state regulatory schemes are concerned with licensure and scope of practice issues, while federal regulations deal primarily with reimbursement and the prevention of healthcare fraud, abuse, and misuse. So reforming telehealth regulations will require both federal and state action.

    “Some states have already made changes to their licensure rules,” Fleming said. For example, Florida has created a specific telehealth license which allows out-of-state providers to become licensed to provide telehealth services in the state. 

    “Hopefully, other states will follow suit. It could create a solution to the lack of certain specialists in particular areas,” she said.

    The Biden Administration has been busy in addressing telehealth concerns.  In August 2021, the Administration announced a $19 million investment in telehealth, going to 36 recipients serving rural areas and underserved communities. This grant money will fund:

    1. Telehealth technology-enabled learning programs., building mentoring capacity in underserved areas. 
    2. Twelve regional and two national telehealth resource centers. These centers will provide resources, information and education on telehealth to healthcare providers.
    3. Evidence-based direct-to-consumer telehealth networks. Bypasses some of the service restrictions.
    4. The creation of telehealth centers of excellence programs. These centers will assess and improve services in rural and underserved areas with high disease and poverty rates. This work will include piloting new services and publishing research. 

    “This award money is exciting because it provides funding for the growth of the actual telehealth structure,” Fleming said.

    Looking Ahead: The Near-Future of Telehealth

    Of course, expanded access to telehealth services requires that patients have high-speed broadband internet connections.

    “We assume that if telehealth exists that everyone can use it, and that simply is not the case,” Fleming said. Many remote rural areas, in particular, struggle with broadband access. The sweeping federal Infrastructure Investment and Jobs Act seeks to address this disparity by providing $65 billion to expand broadband infrastructure.

    “The Infrastructure Investment and Jobs Act also has an expansion of Medicare for telehealth, especially for mental health,” Peck said. “A lot of literature coming out of the pandemic shows that the need for mental health has increased greatly, and telehealth is a good platform for mental health care.”

    In July, CMS published its 2022 proposed physician fee schedule. The proposal includes extending telehealth services for certain mental health care through 2023 or even permanently. Fleming said this will remove many barriers for receiving mental health care.

    “Studies have shown that over a third of the population lives in an area without mental health providers. There’s a real shortage of providers in this field,” she said.

    Another change, in response to the opioid epidemic, is that CMS is proposing that the home can be a site for treating substance abuse disorders.

    Finally, CMS is asking providers for data about Category 3 telehealth services. This class of services was created during the pandemic to designate healthcare services that can be provided temporarily via telehealth. CMS is now looking at whether there is sufficient evidence to support permanent telehealth coverage of those services.

    “Reimbursement is critical because nobody is going to provide services if they aren’t paid for them,” Peck said.

    Reimbursement is one of several complex issues that must be considered during any permanent extension of telehealth exemptions. For example, Peck said that if a matter can be resolved in a five-minute phone call, should it be reimbursed at the same rate as an in-office visit?  Other challenges remain, including the low rates of telehealth adoption in low-income and low English proficiency communities.

    But even with the challenges, Peck and Fleming believe telehealth will remain an important platform for delivering healthcare services, even after the COVID-19 pandemic recedes.

    “All in all, if there’s one thing the pandemic taught us, it’s that telehealth is a viable option,” Peck said. “Perhaps not by itself—we need to look at how telehealth and in-office visits can work together. But telehealth is a way to have a more efficient, equal healthcare system.”

     September 29, 2021
  • sam patrick posted an article
    Infectious disease physician calls for vaccinations see more

    Compliments of the Los Angeles Times

    My patient sat at the edge of his bed gasping for air while he tried to tell me his story, pausing to catch his breath after each word. The plastic tubes delivering oxygen through his nose hardly seemed adequate to stop his chest from heaving. He looked exhausted.

    He had tested positive for the coronavirus 10 days ago. He was under 50, mildly hypertensive but otherwise in good health. Eight days earlier he started coughing and having severe fatigue. His doctor started him on antibiotics. It did not work.

    Fearing his symptoms were worsening, he started taking some hydroxychloroquine he had found on the internet. It did not work.

    He was now experiencing shortness of breath while doing routine daily activities such as walking from his bedroom to the bathroom or putting on his shoes. He was a shell of his former self. He eventually made his way to a facility where he could receive monoclonal antibodies, a lab-produced transfusion that substitutes for the body’s own antibodies. It did not work.

    He finally ended up in the ER with dangerously low oxygen levels, exceedingly high inflammatory markers and patchy areas of infection all over his lungs. Nothing had helped. He was getting worse. He could not breathe. His wife and two young children were at home, all infected with the virus. He and his wife had decided not to get vaccinated.

    Last year, a case like this would have flattened me. I would have wrestled with the sadness and how unfair life was. Battled with the angst of how unlucky he was. This year, I struggled to find sympathy. It was August 2021, not 2020. The vaccine had been widely available for months in the U.S., free to anyone who wanted it, even offered in drugstores and supermarkets. Cutting-edge, revolutionary, mind-blowing, lifesaving vaccines were available where people shopped for groceries, and they still didn’t want them.

    Outside his hospital door, I took a deep breath — battening down my anger and frustration — and went in. I had been working the COVID-19 units for 17 months straight, all day, every day. I had cared for hundreds of COVID patients. We all had, without being able to take breaks long enough to help us recover from this unending ordeal. Compassion fatigue was setting in. For those of us who hadn’t left after the hardest year of our professional lives, even hope was now in short supply.

    Shouting through my N95 mask and the noise of the HEPA filter, I introduced myself. I calmly asked him why he decided not to get vaccinated.

    “Well, I’m not an anti-vaxxer or anything. I was just waiting for the FDA to approve the vaccine first. I didn’t want to take anything experimental. I didn’t want to be the government’s guinea pig, and I don’t trust that it’s safe,” he said.

    “Well,” I said, “I can pretty much guarantee we would have never met had you gotten vaccinated, because you would have never been hospitalized. All of our COVID units are full and every single patient in them is unvaccinated. Numbers don’t lie. The vaccines work.”

    This was a common excuse people gave for not getting vaccinated, fearing the vaccine because the Food and Drug Administration had granted it only emergency use authorization so far, not permanent approval. Yet the treatments he had turned to — antibiotics, monoclonal antibodies and hydroxychloroquine — were considered experimental, with mixed evidence to support their use.

    The only proven lifesaver we’ve had in this pandemic is a vaccine that many people don’t want. A vaccine we give away to other countries because supply overwhelms demand in the U.S. A vaccine people in other countries stand in line for hours to receive, if they can get it at all.

    “Well,” I said, “I am going to treat you with remdesivir, which only recently received FDA approval.” I explained that it had been under an EUA for most of last year and had not been studied or administered as widely as COVID-19 vaccines. That more than 353 million doses of COVID-19 vaccine had been administered in the U.S. along with more than 4.7 billion doses worldwide without any overwhelming, catastrophic side effects. “Not nearly as many doses of remdesivir have been given or studied in people and its long-term side effects are still unknown,” I said. “Do you still want me to give it to you?”

    “Yes” he responded, “Whatever it takes to save my life.”

    It did not work.

    My patient died nine days later of a stroke. We, the care team, reconciled this loss by telling ourselves: He made a personal choice not to get vaccinated, not to protect himself or his family. We did everything we could with what we had to save him. This year, this tragedy, this unnecessary, entirely preventable loss, was on him.

    The burden of this pandemic now rests on the shoulders of the unvaccinated. On those who are eligible to get vaccinated but choose not to, a decision they defend by declaring, “Vaccination is a deeply personal choice.” But perhaps never in history has anyone’s personal choice affected the world as a whole as it does right now. When hundreds and thousands of people continue to die — when the most vulnerable members of society, our children, cannot be vaccinated — the luxury of choice ceases to exist.

    If you believe the pandemic is almost over and I can ride it out, without getting vaccinated, you could not be more wrong. This virus will find you.

    If you believe I’ll just wait until the FDA approves the vaccine first, you may not live to see the day.

    If you believe if I get infected I’ll just go to the hospital and get treated, there is no guarantee we can save your life, nor even a promise we’ll have a bed for you.

    If you believe I’m pregnant and I don’t want the vaccine to affect me, my baby or my future fertility, it matters little if you’re not alive to see your newborn.

    If you believe I won’t get my children vaccinated because I don’t know what the long-term effects will be, it matters little if they don’t live long enough for you to find out.

    If you believe I’ll just let everyone else get vaccinated around me so I don’t have to, there are 93 million eligible, unvaccinated people in the “herd” who think the same way you do and are getting in the way of ending this pandemic.

    If you believe vaccinated people are getting infected anyway, so what’s the point?, the vaccine was built to prevent hospitalizations and deaths from severe illness. Instead of fatal pneumonia, those with breakthrough infections have a short, bad cold, so the vaccine has already proved itself. The vaccinated are not dying of COVID-19.

    SARS-CoV-2, the virus that causes COVID-19, has mutated countless times during this pandemic, adapting to survive. Stacked up against a human race that has resisted change every step of the way — including wearing masks, social distancing, quarantining and now refusing lifesaving vaccines — it is easy to see who will win this war if human behavior fails to change quickly.

    The most effective thing you can do to protect yourself, your loved ones and the world is to GET VACCINATED.

    And it will work.

    Anita Sircar is an infectious-disease physician and clinical instructor of health sciences at the UCLA School of Medicine.

  • sam patrick posted an article
    Okra debuts only solution in the nation with verified DEA licensed lab results see more

    Compliments of Charleston Regional Business Journal

    After four-and-a-half years of testing, Okra Medical has perfected its formula for destroying addictive controlled substances, rendering them 100% non-retrievable and irreversible.

    This product, called SafeMedWaste, is the only solution in the nation with verified Drug Enforcement Administration licensed lab results. Besides incineration, the solution is the only tested way to completely break down controlled pharmaceutical substances so that they cannot be reused by humans or animals.

    SafeMedWaste’s formula covers more than 30 types of Schedule I-IV liquid, pill and patch controlled substances, including opioids, cannabis, narcotics and benzodiazepines. It has been patented in the U.S. and is now waiting on approval in other parts of the world.

    “We’ve hired an independent lab out of Michigan that has done all of our testing,” said Marshall Hartmann, CEO of the company founded in 2018 on Johns Island. “They have verified that our product in nature covers a wide range of controlled substances, where no other product has that proof of efficacy.”

    With onsite denaturation, SafeMedWaste works with Drug Enforcement Administration registrants, such as opioid manufacturers, hospitals, surgery centers and law enforcement agencies, to dispose of substances quickly and effectively at a low-cost.

    Rather than having to safely transport discarded substances to incinerators and landfills in an expensive process, sites with a SafeMedWaste container simply dispose of products inside, where molecules will be broken down and chemically denatured to its basic elements.

    Destroyed products can then be thrown away as nonhazardous waste, also reducing the environmental impact of incineration. Denatured controlled substances do not leach into landfills either.

    This process also prevents the chance of diversion, in which an individual’s prescribed controlled substance is transferred to someone else for illicit use, Hartmann said.

    “Our current compatible drug list encompasses every drug that you’ll find in a hospital or prescribed to a patient that’s commonly abused in society,” said Justin Stas, the company’s chief technology officer. “We focused on what the DEA was seeing people abuse, what people were dying from and what was being diverted by health care workers and people in health care settings.”

    The product comes in different sizes, including a 55-gallon drum for places like law enforcement agencies or pharmaceutical companies, where substances accumulate quickly. Substances of different kinds can be disposed of in these containers simultaneously.

    “A lot of facilities store active drugs, so our product gives them the ability to destroy stuff onsite without harboring those drugs in a container, waiting for pickup,” Stas said. “So it completely renders them inert at the facility, stopping that ability for diversion until incineration.”

    Okra Medical is also awaiting a grant to conduct a home-use product clinical study. This product would allow individual consumers to disable drugs right in their own home through the use of a smaller-sized SafeMedWaste container. 

    “Most people get addicted to opioids from taking them from a friend or family’s medicine cabinet, so we’re trying to help solve that problem with this product,” Hartmann said.

    According to the National Survey on Drug Use and Health, 76% of people who use prescription drugs non-medically gain access to them from someone they know.

    While the Food and Drug Administration’s recommended method of at-home disposal includes flushing drugs down the toilet or covering them with undesirable substances like coffee grounds or kitty litter to discourage retrieval, these methods are not 100% effective, Stas said.

    “Flushing puts the drugs back into our water supply, and we’ve had conversations with the wastewater treatment facility in Greenville, and like most facilities nationwide, they cannot remove pharmaceuticals from water supplies,” Stas said. “They don’t have the technology or the funding to be able to do that.”

    “Our product destroys them, making them inert so they’re not going into the water supply; they can’t be used in the landfill,” Stas said. “With coffee grounds, they go into the landfill, but they’re not rendered, not destroyed at all. They’re just covered in coffee grounds or kitty litter.”

    Although Okra Medical originally planned to launch the product during second quarter 2020, the pandemic delayed the process. As the primary focus of hospitals became battling COVID-19 rather than changing procedures on disposing controlled substances, the company has shifted sights to ambulatory surgical centers in its future launch. They also plan to continue testing to expand the list to include chemotherapeutics and steroids, Hartmann said.

  • sam patrick posted an article
    USC Interim President Dr. Harris Pastides, Sec. of Commerce Machelle Baker Sanders to Co-Chair see more

    The South Carolina Institute of Medicine and Public Health (IMPH) and the North Carolina Institute of Medicine (NCIOM) announced today the creation of the Carolinas Pandemic Preparedness Task Force. The task force will be chaired by University of South Carolina Interim President Dr. Harris Pastides and North Carolina Secretary of Commerce Machelle Baker Sanders.  

    Over the past year, IMPH and NCIOM have worked jointly to develop this initiative, which will provide North and South Carolina with recommendations for a resilient response to future disease outbreaks. Task force members, led by steering committee representatives from both states, will work and learn collaboratively to develop evidence-based recommendations to support future state and local planning efforts.

    The task force will examine lessons learned during the current pandemic in areas related to health, education and economic and social stability with a guiding focus on equity and responding to the needs of historically marginalized and vulnerable populations.

    With funding and support from The Duke Endowment, the Kate B. Reynolds Charitable Trust, the BlueCross® BlueShield® of South Carolina Foundation (an independent licensee of the Blue Cross Blue Shield Association), and the North Carolina Department of Health and Human Services, steering committee meetings are underway. Full task force meetings will take place from July 2021 to April 2022, followed by the publication of a final report from each state in June 2022.

    About IMPH

    The South Carolina Institute of Medicine & Public Health (IMPH) is a nonpartisan, nonprofit organization working to collectively inform policy to improve health and health care in South Carolina. In conducting its work, IMPH takes a comprehensive approach to advancing health issues through data analysis and translation and collaborative engagement. IMPH seeks to achieve its mission by convening a diverse group of stakeholders around health issues important to South Carolina. Learn more at imph.org