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  • sam patrick posted an article
    South Carolina life sciences is surging across the state, experts say see more

    As Published in Greenville, Columbia and Charleston Business Magazines

    When describing today’s South Carolina’s life sciences industry, words like "surging" and “booming” are often mentioned.

    Life sciences is diverse, with seven sectors: drugs and pharmaceuticals; medical devices and equipment; digital health solutions; research, medical and testing laboratories; bioscience distribution; bio-agriculture and ecosystem support. 

    Surprisingly, life sciences are South Carolina’s fastest-growing industry -- not more expected industries like automotive, tires, or aerospace, notes Erin Ford, Interim CEO of SCBIO -- a nonprofit dedicated to building, advancing and growing life sciences here. 

    “A 2017 study by USC's Moore School of Business showed 402 life science companies in South Carolina –  that’s grown to over 700 today.  It employed over 43,000 South Carolinians and generated $12 billion in impact,” said Ms. Ford. 

    To read the complete story, please click here...

  • 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
    Vigilent Labs to distribute COVID-19 test kits and digital health credentials see more

    Enables Vigilent Labs to distribute COVID-19 test kits and digital health credentials to government organizations through GSA schedule

    Vigilent Labs, an advanced health and medical technology company that provides solutions for the detection, identification and assessment of health and bio-threats, has formed a partnership with Seroclinix and Davenport Aviation to distribute COVID-19 test kits and Vigilent Labs v.Pass digital credential technology through Davenport Aviation’s General Services Administration (GSA) Contract.

    “Our government division has worked on adding much-needed medical supplies to our GSA contract to meet our nation’s most pressing needs during the COVID-19 pandemic,” said Rob McMillin, Davenport’s Senior Program Manager. “We are pleased to partner with Vigilent Labs and Seroclinix to provide test kits to government customers through our GSA Contract (#GS-07F-139DA).”

    The COVID-19 Rapid Test kit partnership with SeroClinix’s cost-effective SIENNA Antibody Tests produces fast, reliable and accurate results in seven to 10 minutes, which are CE-marked useful for COVID-19 screening and surveillance under CDC guidance, recently received high marks fro3m the latest International Journal of Infectious Diseases evaluation, and now authorized and approved for purchase through GSA Advantage. A critical advantage of this partnership is the Vigilent Labs “v.LABS” platform and its ability to convert the SIENNA test results into a digital credential that includes one’s COVID-19 Test Results in a v.PASS, facilitating near-real-time health surveillance.

    “Vigilent Labs leverages our existing capability with leading-edge technology to provide a comprehensive solution to the medical community from the Point Of Care environment to the executives and managers responsible for healthcare decision making,” said John Falk, President of Vigilent Labs. “We are proud of this strategic partnership and to provide quality testing and credential solutions to government organizations.”

    This partnership marks an important milestone for Vigilent Labs as an authorized GSA/Government reseller and distributor for COVID-19 Antigen and Antibody test kits in the United States for the United States government.

    “We are excited for our partnership with Vigilent Labs in providing fast and effective test kits for the government,” said Howard Lee, Chief Executive Officer of Seroclinix. “These tests are not only cost-effective but also have the highest reviews made by independent medical evaluations as to the accuracy of the test.”

    To learn more about Vigilent Labs’ solutions for COVID-19 testing and monitoring, visit www.vigilentlabs.com.

     

    About Vigilent Labs

    Vigilent Labs is an advanced health and medical technology company that provides solutions for the detection, identification and assessment of health and bio-threats. The company provides point-of-care (POC) medical testing devices, initially centered on the COVID-19 pandemic, paired with a comprehensive digital health and credentialing platform that offers near real-time tracking of disease. Founded in 2019, Vigilent Labs is headquartered in Charleston, South Carolina, with additional manufacturing and production facilities in Laramie, Wyoming and throughout the United States. For more information, visit www.vigilentlabs.com.

  • sam patrick posted an article
    Chartspan relocating headquarters in Greenville, SC see more

    A Greenville-based healthcare technology service is changing where its employees work due to unexpected consequences of COVID-19.

    ChartSpan is downsizing from its 100,000-square foot headquarters at 2 N. Main St. in downtown Greenville, into a 10,000-square foot location near Liberty Bridge.

    The new space will be used mostly by the company’s executives and leadership teams, as the company moves to a remote-only call center, meaning nearly 200 employees will work from home.

    ChartSpan's announcement comes as the vacancy rate in Greenville's Downtown Class A vacancy rates declined to 7.06% and its Class A office property rental rates dropped to $26.16 per square foot in second quarter 2020, according to the newly released Collier International 2020 Q2 Office Greenville-Spartanburg Report.

    Read the entire article, courtesy of The Greenville News and Gannett

  • sam patrick posted an article
    MUSC, Siemens Healthineers craft extraordinary agreement to advance healthcare see more

    The Medical University of South Carolina and Siemens Healthineers have formed a first-of-its-kind strategic partnership with the mutual goal of advancing the quality of health care in South Carolina. The partnership will capitalize on the coupling of MUSC’s clinical care, research and education expertise with Siemens Healthineers’ engineering innovations and workflow-improvement capabilities.

    “We are leveraging a longstanding relationship to reshape what we can both deliver in health care,” said David J. Cole, M.D., MUSC president. “Our nation is demanding that we address our fractured, costly and inefficient health care delivery systems. As the leading academic health sciences center in this state, MUSC’s purpose must be to drive the highest quality care for our patients at the lowest cost through commitment and partnerships. In discussions with the Siemens Healthineers team, we discovered a high degree of alignment with these concepts, and we are very excited to have them move forward with us. Our mutual goal is to not merely provide the best care possible for just our patients; we will define the new gold standard for others to follow.”

    Specifically, this new agreement will focus on driving performance excellence at MUSC and generating significant clinical and value-driven innovations in focused target areas including pediatrics, cardiovascular care, radiology, and neurosciences.

    “Ultimately, our goal is to enable health care providers to get better outcomes at lower cost. We will achieve that by empowering MUSC clinicians on this journey through four specific areas of focus – expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing health care,” said Dave Pacitti, president of North America for Siemens Healthineers. “These four core values of Siemens Healthineers are representative of the goals of our strategic relationship with MUSC, and we hope that the spirit of this flagship partnership will initiate a trend in value based care within the industry.”

     

    Read the entire article by clicking here.