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  • 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
    Over twenty experts to speak on major business issues see more

    Subject matter leaders from across state, nation to cover what business needs to know to thrive despite pandemic, how to leverage state’s fastest-growing knowledge economy segment

     

    SOUTH CAROLINA – September 2, 2020 – SCBIO will host a half-day virtual program September 23 -- Life Sciences Boot Camp: Building Your Brand & Business In a Pandemic – to inform and connect businesses, educators and professionals from across the state on leveraging opportunities, identifying trends and overcoming challenges that face organizations interested in tapping into South Carolina’s fastest-growing industry segment.

    To be held completely online, the program will run from 8:15 a.m. until 12:15 p.m. on Wednesday, September 23rd.  The program is delivered free to all SCBIO Members and Investors, and for a nominal fee of $50 to all non-Members.  Students and media may also attend free of charge.  Six sessions featuring over 20 noted presenters will precede a closing Virtual Networking Session for all attendees. Confirmed topics and speakers include:

    • Search for a Cure:  A National Update on the Global Pandemic – featuring a live national report from PhRMA executive Sharon Lamberton on success in battling the COVID-19 pandemic, and what lies ahead for America
    • Marketing in a Pandemic:  Building Your Brand & Your Topline – despite the economic turndown, some businesses are enjoying even great success – and are positioning themselves for an even better future.  Learn the secrets to thriving, not surviving, during and after the pandemic from Henry Pellerin of Vantage Point, Heather Hoopes-Matthews of NP Strategy and Jessica Cokins of Thorne Research
    • Best Practices in Talent Recruiting, Retention & Development – Nephron's Lou Kennedy, Arthrex's Jimmy Dascani and ERG's Matt Vaadi share how the state’s life sciences leaders are attracting, training and retaining top talent – and offer ideas your organization can deploy right now
    • Partnering Effectively with Higher Education & Research Universities – tap into the wealth of resources, knowledge and experience prevalent in the state’s  research universities to enhance innovation and success.  Enjoy insights from Chad Hardaway of USC’s Office of Economic Engagement, Michael Rusnak of MUSC’s Foundation for Research Development, and Angela Lockman of Clemson
    • Leading Virtual Teams Effectively – the pandemic has showed us that working virtually is here to stay.  Find out how to make your organization collaborate seamlessly, efficiently and effectively -- wherever your colleagues are located -- from Annie McCoy of ChartSpan, Andrew Collins of Alcami and Jenni Dunlap of Parker Poe
    •  Pivoting with a Partner:  Collaborating to Grow Your Business – learn how to successfully identify and partner with other organizations to expand and enhance product/service offerings.  Hear incredible stories from the teams at Zverse/Phoenix Specialty and Rhythmlink, ZIAN and MUSC as they share their stories -- and how you can find your next great opportunity.

     The program will end with a Virtual Networking session offering attendees to chat with leading economic development professionals including Stephanie Few of Womble Bond Dickinson, Tushar Chikhliker of Nexsen Pruet, and John Osborne of Good Growth Capital for conversations on Onshoring, Incentives, Accessing Capital and more.

    To register or for more details, visit the Events page.  Interested students and media members are invited to attend, with advance registration, at no cost.

    SCBIO is South Carolina’s investor-driven public/private economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state.  The industry has an $11.4 billion annual economic impact in the Palmetto State, with more than 675 firms directly involved and 43,000 professionals employed in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products.  The state-wide nonprofit has offices in Greenville, Columbia, and Charleston, and represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries.  Life sciences is recognized as the fastest-growing segment of South Carolina’s knowledge economy.

    For additional information on SCBIO, visit www.SCBIO.org.

     September 02, 2020
  • sam patrick posted an article
    Top life sciences leaders from across the state have been named to the SCBIO Executive Committee see more

    Leadership team provides strategic blend of economic development, industry, higher education expertise

     

    GREENVILLE, SC – January 17, 2019 – SCBIO has announced its 2019 Executive Committee following formal confirmation at the life science organization’s December 2018 meeting in Columbia.  Nephron Pharmaceuticals Corporation CEO Lou Kennedy will serve a second term as SCBIO’s 2019 Board Chair.

    Ms. Kennedy joined Nephron Pharmaceuticals in 2001, and assumed the position of President and CEO in 2007. She has held a variety of marketing and operational roles during her career and has helped Nephron Pharmaceuticals grow by more than 300% and increased shipped product to one billion doses each of the last seven years.  Nephron constructed a state of the art manufacturing facility in West Columbia, South Carolina and, with her husband Bill, helped establish the Kennedy Pharmacy Innovation Center in conjunction with the USC School of Pharmacy.  The organization was honored as an inaugural winner of the South Carolina Life Sciences Pinnacle Award for Organizational Contribution to the industry in October, 2018.

    Joining Ms. Kennedy on the SCBIO Executive Committee will be Stephanie Yarbrough, Partner with Womble Bond Dickinson, LLP as Vice Chair; Michael Rusnak, Executive Director of the MUSC Foundation for Research Development as Treasurer; and Josh Ridley, Global Business Development Director of ZEUS as Secretary.  

    Additional members of the Executive Committee are Jeff Stover, Special Counsel with Haynsworth Sinkler Boyd, PA as Legal Officer; Heather Simmons Jones, CEO of the Greenwood Partnership Alliance as Annual Conference Officer; Bryan Davis, Operations Manager with Greenville Health System’s Office of Innovations as Healthcare/Innovation Officer; Adam Hoots, Life Sciences Market Leader for DPR Construction as Talent/Workforce Officer; and Sam Konduros, President and CEO of SCBIO. 

    Recognized for completing their terms as contributing members of the SCBIO Executive Committee were former Vice Chair Craig Walker, executive with Hitachi Healthcare Americas, and former Secretary Kathryn Becker, Principal with Translational Science Solutions LLC.

    SCBIO President and CEO Konduros praised the Executive Committee noting, “With the critically important efforts we are undertaking to advance pharmaceuticals, life sciences R&D, biotech, med-tech, and the health IT industries in South Carolina, we require strong, expert leadership from across the state, fully integrating our business, education and economic development sectors. These diverse leaders who represent the width and breadth of our state and industry will effectively champion our vision of building the business of life sciences in South Carolina for years to come.”

    SCBIO is South Carolina’s investor-driven public/private economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state.  The industry already has an $11.4 billion annual economic impact in the Palmetto State, with more than 400 firms directly involved and 15,000 professionals employed in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products.  The state-wide nonprofit has offices in Greenville, Columbia, and Charleston, and represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries.

    The Executive Committee and Board of Directors is the policy- and strategy-making body of the organization, and meets regularly to receive updates on SCBIO business and objectives, as well as domestic and global initiatives. The Executive Committee serves roles specific to SCBIO operations, focus areas and strategies.

    SCBIO is the official state affiliate of BIO -- the world's largest trade association representing biotechnology organizations.  SCBIO members include academic institutions, biotech companies, med-tech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups whose members are leading the research and development of innovative healthcare, agricultural, industrial and environmental biotech and med-tech products that will make a difference across the Palmetto State, and around the world.

    For additional information on SCBIO, visit www.SCBIO.org