National magazine does cover story on Greenville's Precision Genetics see more
The February 2022 issue of Healthcare Business Review magazine features Greenville, South Carolina-based Precision Genetics in a fabulous story entitled "Where Precision Healthcare Meets Genetics". The cover story addresses such topics as the role of genetics in mental health... the pandemic's impact on mental health... a look ahead at the future of healthcare. Click here to enjoy the complete article.
FDA Grants Emergency Use Authorization to Premier Medical Laboratory Services for At-home COVID-19 TestAssay designed for RapidRona at home tests see more
Premier Medical Laboratory Services (PMLS), one of the largest private medical diagnostics laboratories in the US has provided results for millions of COVID-19 tests since the beginning of the pandemic, contributing largely to the national COVID-19 response. They have also implemented one of the largest variant surveillance initiatives in the country with the capability to sequence up to 42,000 specimens per day. Now, they have been granted Emergency Use Authorization (EUA) from the Food and Drug Administration to process results for at-home COVID-19 tests.
The RT-PCR-based SARS-CoV-2 assay now authorized by the FDA is designed for RapidRona at home tests which can be ordered online at www.rapidrona.com. RapidRona enables those who would like to test for COVID-19 to collect their own sample at home by a minimally invasive nares swab and then send the specimen with prepaid shipping to the lab for processing of results. Polymerase Chain Reaction (PCR) tests have been known throughout the pandemic as the gold standard of testing methods due to the highly accurate results that they provide.
“Our scientists have worked diligently to take the steps necessary in receiving the EUA for this test,” said Kevin Murdock, Founder and CEO of Premier Medical Laboratory Services. “We did this because we know how important it is to enable the population to more easily access reliable COVID-19 tests with fast turnaround times from home. We’re proud that this is another way we can provide effective solutions for COVID-19 management.”
At-home COVID-19 tests have been reported as difficult to find during the Omicron surge. The EUA attained by PMLS will allow more people the ability to test and mitigate the spread of the virus. Because some countries around the world only accept incoming travelers who have taken a RT-PCR test with a negative result, RapidRona is the choice for at-home testing among travelers. Returning schools and businesses can also reduce viral transmission rates utilizing RapidRona’s sample collection method designed for improved comfortability, keeping infected employees, students, and staff to a minimum.
PMLS is part of a house of brands under Diversified Medical Healthcare which manufacture testing supplies, develops medical data management software, and provides PPE to seamlessly meet the needs of organizations without delay or disruption.
During the pandemic, PMLS has:
- Processed millions of COVID-19 tests with a turnaround time of 24 hours or less
- Served as the choice processing lab for Health and Human Services testing sites
- Been the trusted COVID-19 management partner for professional sports teams, schools, colleges, large corporations, and health departments spanning from coast to coast
ABOUT PREMIER MEDICAL LABORATORY SERVICES: Premier Medical Laboratory Services (PMLS), based in Greenville, South Carolina, is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including CLIA and COLA. With the most advanced laboratory information systems (LIS), easy to read one-page test result reports are generated with higher accuracy and a customizable report for each client. PMLS prides itself on having some of the most rapid turnaround times for testing results in the industry and patient-friendly billing. Their expansive testing menu includes advanced Cardiovascular Testing, Diabetes panels, Pharmacogenomics, COVID-19 testing, Women’s Wellness panels, Allergen Specific Ige Blood Testing, and Toxicology. For more information, please visit www.PreMedInc.com or call 1.866.800.5470.
Life sciences firm seeking to add hundreds of new employees see more
Premier Medical Laboratory Services, has recently reported a rapid increase in medical testing demands coming to their laboratory – the amount of COVID-19 tests alone being processed at their Greenville, SC facility has jumped 250% in the last two weeks. Much of this is due to the Omicron variant, which first made landfall in the US at the beginning of December and is now the dominant strain of the virus in the nation. With this influx of tests poses an immediate need for hundreds of Upstate employees to be hired at the medical laboratory.
“Throughout the pandemic we’ve been proactive in fulfilling our staffing needs,” said Kevin Murdock, CEO and Founder of Premier Medical Laboratory Services. “To ensure that we continue to properly meet testing demands amid this new surge, we are looking to vastly expand our team and to provide jobs in the community.”
PMLS is a CLIA and COLA certified laboratory. They are the choice processing lab for Health and Human Services testing sites, and the trusted COVID-19 management partner for professional sports teams, schools, colleges, large corporations, and health departments across the nation. With an expanding team, they are inviting members of the Upstate community to join them in providing vital services and information, helping to battle COVID-19 and its new variants and to improve the future of healthcare with advanced medical diagnostics. Currently, the lab is looking to fill the following positions:
Lab Data Entry Clerk
- NO EXPERIENCE NEEDED
- Job duties include entering patient information into a computer system, scanning barcodes, and helping with any other lab assistant needs
- Protective gear and all training are provided by the lab
Job Type: Part-Time; Pay: $15 per hour
Medical Laboratory Technician
Responsible for performing medical tests in the Molecular Lab. Does not need to be certified if a degree in Chemistry or Biology have been attained.
- Collect and organize blood, tissue, and other bodily fluid samples from patients
- Prepare samples for routine testing and analysis
- Properly record results for further analysis and easy reference
- Monitor inventory samples and supplies
- Maintain a clean work environment
- You must have experience as a Medical Technologist (ASCP Certificate that is CURRENT is a plus!)
- BS in Biology or Chemistry is also helpful
- Familiarity with common medical terminology
- Experience in a laboratory setting
- Strong organizational skills
Job Type: Full-time; Pay: $18-$22 per hour
- ***MUST HAVE EXPERIENCE WITH MANUAL EXTRACTION PROCESSES***
- Has earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution
- Has at least 2 years of current laboratory experience, in moderate complexity testing (Chemistry, Hematology, Urinalysis)
- Has 2 years of laboratory training or experience in high complexity testing (Allergy and/or Molecular)
Job Type: Full-time; Pay: $24-$28/hr
All positions located in Greenville, SC. Please email: HR@DIVMEDINC.COM to apply. For more information, please visit www.PreMedInc.com or call 1.866.800.5470.
ABOUT PREMIER MEDICAL LABORATORY SERVICES
Premier Medical Laboratory Services (PMLS), based in Greenville, South Carolina, is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including CLIA and COLA. With the most advanced laboratory information systems (LIS) easy to read one-page test result reports are generated with higher accuracy and a customizable report for each client. PMLS prides itself on having some of the most rapid turnaround times for testing results in the industry. Their expansive testing menu includes Pharmacogenomics, COVID-19 testing, Advanced Cardiovascular Testing, Diabetes, Women's Wellness panels, Allergen Specific Ige Blood Testing, Toxicology, and a first of its kind predictive genetic test for type II diabetes, DIABETESPredict. For more information, please visit www.PreMedInc.com.
Premier Medical Laboratory Services, in Partnership with the Clemson University, Reports Omicron Variant Now Present in Upstate, SCPremier Medical, Clemson detect latest variant in Upstate region see more
December 20, 2021 – Today, Premier Medical Laboratory Services (PMLS), headquartered in Greenville, SC, reports their findings that the Omicron variant is now confirmed to be present in the Upstate. The laboratory has been surveilling for Omicron and other novel variants through Next Generation Sequencing (NGS) in partnership with the Clemson University Bioengineering Department. Clemson University REDDI Lab has collected samples for COVID-19 testing from throughout the upstate community and was funded through the National Institutes of Health (NIH) to then have the COVID-19 positive specimens undergo NGS at PMLS. NGS is the process of decoding the genetic make-up of the virus to track how it is mutating and spreading throughout the population.
“As a proactive and solutions-driven company, we implemented Next Generation Sequencing to meet the needs of our population with preparedness for novel variants like Omicron,” said Kevin Murdock, CEO and Founder of Premier Medical Laboratory Services. “Through partnerships like ours with Clemson University, we are happy to increase the amount of data for South Carolina and the entire nation which is vital for vaccine efficacy and our understanding of the virus.”
Knowing the importance of accumulating data in the continued fight against the pandemic, PMLS implemented one of the largest sequencing initiatives among any lab in the nation – with the capability to sequence up to 42,000 samples per week. Many labs that are conducting COVID-19 testing have not developed the capabilities to conduct sequencing, and new variants cannot be fully identified via COVID-19 diagnostic testing methods alone. PMLS will continue working to uncover any further novel variants and mutations that COVID-19 presents and notify health officials.
Other ways PMLS has helped to meet demands during the pandemic:
- Processing lab for Human Health Services surge sites and several state health departments
- Blue Cross Blue Shield preferred COVID-19 testing lab in several states
- Reached one of the highest testing capacities in the nation with the capability to process over 300,000 tests per day
- Developed medical data management software that communicates directly from laboratory equipment for faster HIPAA compliant delivery of data to healthcare providers and patients
- Shifted production to add in-house manufacturing of COVID-19 testing kits
- Donated thousands of COVID-19 tests to children's diabetes summer camps throughout the nation
- Donated hundreds of thousands of masks to local law enforcement, paramedics, fire departments, hospitals, and the Shriners organization and has provided free testing to first responders during the pandemic
For more information, please visit www.premedinc.com or call 1.866.800.5470.
ABOUT PREMIER MEDICAL LABORATORY SERVICES
Premier Medical Laboratory Services (PMLS), based in Greenville, South Carolina, is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including CLIA and COLA. With the most advanced laboratory information systems (LIS) easy to read one-page test result reports are generated with higher accuracy and a customizable report for each client. PMLS prides itself on having some of the most rapid turnaround times for testing results in the industry. Their expansive testing menu includes Pharmacogenomics, COVID-19 testing, Advanced Cardiovascular Testing, Diabetes, Women's Wellness panels, Allergen Specific Ige Blood Testing, Toxicology, and highly advanced diabetes test, MDDiabeticPro. For more information, please visit www.PreMedInc.com
SCRA makes third investment in Zylo Therapeutics see more
South Carolina Research Authority (SCRA’s) investment affiliate, SC Launch, Inc. has made its third investment into Zylö Therapeutics, Inc. This $300,000 investment will help the company continue providing therapeutic topical solutions.
Zylö Therapeutics became an SCRA Member Company in 2018 and received a $21,500 Project Development Fund Grant. They also received a $41,000 SBIR/STTR Matching Grant in 2020. Zylö also became an SC Launch, Inc. Portfolio Company in 2019 when they received their first investment of $200,000. They also received a $182,500 investment as part of SC Launch, Inc.’s pandemic funding round to startups providing COVID-19 solutions.
Zylö developed a sustained-release drug delivery system that uses patented xerogel-derived particles, called Z-pods™, to topically deliver Nitric Oxide and other notoriously hard-to-deliver therapeutic agents. The technology enables a product concept called the Patchless Patch™, an innovative, competitive response to a lidocaine patch.
SCRA Investment Manager Steve Johnson said, “Technology applied to health care challenges is a powerful tool and the Zylö Z-pod® delivery system is creating value not only in health care but in a wide range of applications, from medicine to agriculture. These solutions have the potential to benefit us all.”
Founder and CEO Scott Pancoast said, “We knew we discovered something special with our breakthrough delivery technology. The highly engineered silica-derived Z-pods enable us to improve performance of a wide range of payloads. Our success is changing the way treatments can be delivered via the skin, providing sustained release with fewer systemic side effects. The teams at SCRA and SC Launch, Inc. continue to be trusted partners, and we’re glad they are on this journey with us.”
Scott Pancoast was a recent guest in our CEO Podcast Series. Listen to learn more about Zylö’s progress with silica particles, Nitric Oxide, and other developments for medical treatment solutions.
“The list of health care conditions to be treated by Zylö’s developments continues to grow. They are pursuing solutions to help patients with lupus, hair loss, joint pain, and even burns, just to name a few. Their commitment to innovative treatment discoveries have set them on a path of continued growth and success. We’d excited to have them in our portfolio of companies,” said Bob Quinn, SCRA Executive Director.
About SC Launch Inc.
Established in 2006, SC Launch, Inc. is the investment affiliate of the South Carolina Research Authority. The independent nonprofit corporation provides loans and investments to selected South Carolina-based companies participating in the SC Launch program.
Chartered in 1983 by the State of South Carolina as a public, nonprofit corporation, South Carolina Research Authority (SCRA) fuels South Carolina’s innovation economy through the impact of its four programs. SC Academic Innovations provides funding and support to advance translational research and accelerate the growth of university-based startups. SC Facilities offers high-quality laboratory and administrative workspaces for technology-based startups and academic institutions. SC Industry Solutions facilitates and funds partnerships between and among startups, industry, and academia. SC Launch mentors and funds technology-based startups that may also receive investments from SCRA’s investment affiliate, SC Launch, Inc.
The Impact of COVID-19 on Clinical Research in the Life Sciences Industry: Is there a Silver Lining?Long term impacts of COVID-19 across the health care spectrum are still to be determined see more
Clinical research is one of the foundations of the Life Sciences industry as it involves the scientific investigation and treatment of diseases and other medical conditions in order to improve medical knowledge related to the diagnosis, treatment, and prevention of such diseases and medical conditions. Clinical research is the underlying process that results in the development of ground breaking new drugs and treatments that cure or treat diseases that improve all of our lives. One of the best and most recent examples of the importance of clinical research is the development of vaccines for the COVID-19 virus which to date has taken the lives of over 5 million people across the globe since early 2020.
The impact of the COVID-19 pandemic on the clinical research industry has been profound and in some respects may prove to be an inflection point for the Life Sciences industry.
The COVID-19 pandemic created massive disruption within the world of clinical research. In 2020, over 79% of ongoing clinical trials were disrupted in one way or another by COVID-19. The disruptions ranged from stopping ongoing trials, pausing recruitment of ongoing trials and pausing the development of new clinical study sites. Enrollment in clinical trials dropped dramatically during the early stages of the pandemic as potential participants were reluctant to make trips to hospitals or other research sites. In addition, many investigators, sub-investigators, and research staff had to shift focus to COVID related support instead of working on clinical research efforts.
Beyond the disruption to existing clinical research studies, however, COVID-19 has had other impacts on the clinical research industry that could have a potentially positive impact on how clinical research is conducted in the future.
COVID-19 Resulted in an Acceleration of the Clinical Research Process
When faced with the rapidly spreading COVID-19 virus, pharmaceutical companies and governments collaborated to accelerate the clinical research process in order to develop a vaccine that would work against COVID-19. Previously, the fastest a vaccine had been developed in the U.S. was four years when the vaccine for the mumps virus was developed in the 1960s. In light of the global health emergency created by the COVID-19 pandemic, researchers were able to reduce the normal time to arrive at a vaccine by years. How was this done? One of the reasons for the rapid development of the COVID-19 vaccine was the years of prior research on vaccine development for other viruses, like HIV. Researchers were also able to quickly determine the specific genetic makeup of the SARS-COV-2 virus by early 2020 and they used technology from RNA-based templates to develop a potential vaccine. Another important factor in streamlining the development for the COVID-19 vaccine was the hundreds of thousands of people who volunteered to participate in the clinical studies for the vaccine development. In addition, the U.S. Government implemented Operation Warp Speed which provided very large government contracts and research grants to pharmaceutical companies to research and produce vaccines. The U.S. Government also had the FDA advance all COVID-19 vaccine clinical research studies to the front of the regulatory approval line through the use of emergency use authorizations (EUAs). This lead to the development of multiple COVID-19 vaccines that were ready for mass distribution within 1 year of the identification of the COVID-19 virus, which is a remarkable accomplishment. The FDA also used EUA to expedite other responses to COVID-19 by approving new testing and additional sources and types of personal protective equipment (“PPE”). The development and distribution of the vaccine was a groundbreaking accomplishment that reflected the resilience and innovation of the clinical research industry. According to some clinical researchers, the rapid creation of COVID-19 vaccines is “a sea change in how to develop vaccines in the future.”
As we continue to work through the COVID-19 pandemic, it remains to be seen how much faster future clinical research studies will be accelerated in the future based on our COVID-19 clinical research experience. The FDA is under both political and media pressure to accelerate its approval process because of the COVID-19 experience and the clinical research industry is looking at its normal processes to determine if things can and should be done in a different way in order to streamline and accelerate the overall process while at the same time maintaining safety and scientific integrity.
A New Focus on the Clinical Research Participant
Another potential change in clinical research that was caused in part by COVID-19 is an effort by clinical trial sponsors to focus more on the clinical trial participant and their experience during the clinical trial. This includes trying to reduce the administrative burden on clinical trial participants and making the process simpler and easier for participants to navigate. Clinical trial sponsors are also evaluating trials with more of a focus on quality of life for the participants and increasing the use of patient support groups or patient advocates so it is easier for clinical trials to recruit new participants and to keep the participants engaged throughout the life of the clinical trial.
Use of More Decentralized Clinical Research
A decentralized clinical trial (DCT) is defined as a clinical study executed through telemedicine and mobile /local healthcare provider processes and technologies that brings the trial’s activities to the patient at home rather than using the traditional model of bringing patients to a trial site. Because much of the world was in lockdown mode to deal with the implications of COVID-19, clinical researchers increased the use of DCTs during 2020. This included the use of more virtual encounters and technology to connect clinical trial participants with the investigators. It is anticipated that this will occur more in the future as researchers can gather better data when it is easier for patients to report the data. With DCTs, patients can report data via their smart phone or tablets from home instead of having to be physically present at a clinical research site. Use of DCTs is also seen as a successful tool in recruiting the appropriate patient populations by increasing both access to clinical trials and the overall diversity of trial participants. Having a diverse group of clinical trial participants can help ensure that the drug or device being tested is safe and effective.
Increased use of Digital Technology
The use of digital technology by patients and participants in clinical trials has steadily increased over the last several years. During COVID-19 and with the increase in DCTs, the use of mobile devices such as smart phones or tablets, digital wearables or other types of biosensors have steadily increased. The use of this digital technology provides clinical researchers with access to continuous data for longer periods of time and it is easier for clinical trial participants to use this technology on a daily basis without disruption to their daily lives. The use of digital technology has also increased the opportunity for clinical trial sponsors to obtain real-world data (RWD) and real-world evidence (RWE) from clinical study participants. This result stemmed in part from the FDA’s launch of a program focused on the increased use of RWD and RWE. This kind of information has been used to support clinical trial designs and studies to generate innovative approaches to clinical studies.
Is there a silver lining from COVID-19 when it comes to clinical trials?
The long term impacts of COVID-19 across the health care spectrum still remain to be determined, but one of the short term impacts of this global pandemic could prove to be potentially significant and positive changes in the way that the clinical research industry operates. These changes could lead to a faster clinical research process that embraces the use of new technology such as digital therapeutics and development of a broader and more diverse base of clinical participants.
For a look at the regulatory framework for clinical trials in the life science industry and the risks faced by companies within the industry – including a discussion of potential future changes caused by the pandemic – watch Nexsen Pruet’s on-demand webinar, “Understanding Clinical Research Framework and Challenges in the Life Sciences Industry,” presented by Matthew Roberts of Nexsen Pruet and Rakel Meir of Biogen.
Womble Bond Dickinson provide insight into telehealth during the pandemic see more
- 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:
- Telehealth technology-enabled learning programs., building mentoring capacity in underserved areas.
- Twelve regional and two national telehealth resource centers. These centers will provide resources, information and education on telehealth to healthcare providers.
- Evidence-based direct-to-consumer telehealth networks. Bypasses some of the service restrictions.
- 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.”
Op-Ed: As a doctor in a COVID unit, I’m running out of compassion for the unvaccinated. Get the shotInfectious disease physician calls for vaccinations see more
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.
Okra debuts only solution in the nation with verified DEA licensed lab results see more
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.
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.
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