In this episode, Carrie and Blake discuss: 

• What exactly is "deviceless remote patient monitoring"?
• Why did CareSignal choose to focus in the value-based care space as early as 2015 -- and how did they succeed there?
• What role do Social Determinants of Health play in value-based care models?

Key Takeaways: 

• Deviceless remote patient monitoring strikes a good balance between remote monitoring and patient engagement for value based care without relying on peripheral devices. 
• When a product is designed to be easy to use, it becomes accessible to as many people as possible and therefore has the potential to help as many people as possible too.
• CareSignal decided from a risk-reward perspective that it was optimal to take the risk that the value based care trend wouldn't pan out. The reward if they could build the first product that could really scale for remote monitoring and engagement in a true value based care arena would make that risk worthwhile.
• A lot of physicians and clinicians are experiencing burnout as well as staffing shortages. This fear that technology will displace them actually allows for companies to position their technology as a way to allow physicians and clinicians to operate at their highest level of practice while some of the other things are taken care of by technology. 

“Improving health equity by supporting social determinants of health is the right thing to do clinically, as humans. But now, it's the right thing to do financially as well. And it's just going to become more and more so.” - Blake Marggraff

Connect with Blake Marggraff: 

Website: https://caresignal.health/ 

LinkedIn: https://www.linkedin.com/in/marggraff/ 

Twitter: https://twitter.com/blakemarggraff 

Learn more from Carrie and Rebecca: 

Healthcare Insights (a monthly deep dive into specific topics for innovators): https://nixongwiltlaw.com/healthcare-insights

Telehealth/Virtual Care Mgmt Update (a biweekly LinkedIn newsletter tracking legal and policy changes across the nation): https://www.linkedin.com/newsletters/telehealth-virtual-care-update-6901900767960068096/ 

Website: https://nixongwiltlaw.com/ 

Carrie on LinkedIn: https://www.linkedin.com/in/carrienixon/ 

Rebecca on LinkedIn: https://www.linkedin.com/in/rebeccagwilt/

NGL on LinkedIn: https://www.linkedin.com/company/nixon-gwilt-law/ 

In this episode, Carrie and Rebecca discuss: 

• What a minimum viable revenue model is
• What 5 questions they ask every new revenue model client
• Why healthcare business rules are different from every other industry
• Why determining a revenue model must include designing a compliant business arrangement
• What happens when your revenue model is noncompliant 

Download the checklist here: https://bit.ly/3TxMKCN

Find the episode transcript at our website: https://nixongwiltlaw.com/dhi-podcast/ 

Key Takeaways: 

• The first question you must ask is, “what are you selling”? For example, a vendor of RPM is often selling software, devices, and clinical services in the form of management services. 
• Identifying who your customers are or what revenue streams you have available is a key step in figuring out what the available payment mechanisms are. You may have more options than you think.
• In healthcare, designing a compliant business arrangement is key to capturing revenue without getting yourself in trouble. Noncompliance is a revenue risk.
• Consider what documents you need to make the arrangement viable.There may be more than you think due to the complexity of the healthcare industry.

“If you’re using those non-compliant business arrangements to capture the revenue, that revenue down the road may be clawed back from you.” - Carrie Nixon

Learn more from Carrie and Rebecca: 

Healthcare Insights (a monthly deep dive into specific topics for innovators): https://nixongwiltlaw.com/healthcare-insights

Telehealth/Virtual Care Mgmt Update (a biweekly LinkedIn newsletter tracking legal and policy changes across the nation): https://www.linkedin.com/newsletters/telehealth-virtual-care-update-6901900767960068096/

Website: https://nixongwiltlaw.com/ 

Carrie on LinkedIn: https://www.linkedin.com/in/carrienixon/ 

Rebecca on LinkedIn: https://www.linkedin.com/in/rebeccagwilt/

NGL on LinkedIn: https://www.linkedin.com/company/nixon-gwilt-law/ 

What you’ll get out of this episode

Rebecca talks with Bethany Corbin and Ashleigh Giovannini, two powerhouse attorneys at Nixon Gwilt Law. These national and international privacy experts highlight what healthcare innovators need to know about the Internet of Medical Things and the evolving privacy and security frameworks for digital health connected devices.

Listen to Discover:

• How to define digital health connected devices
• How the privacy and security and data use challenges for these companies are distinct from the challenges facing other digital health companies
• What trends they are seeing among external bad actors in the space
• What the biggest threat to digital health companies is right now from a security/privacy perspective—and what’s the worst that could happen
• How companies make the risk/benefit tradeoff

And be sure to check out the extensive resources to go along with this episode below.

Guests 

Bethany A. Corbin, Esq., Senior Counsel at Nixon Gwilt Law, advises healthcare and pharmaceutical clients-including femtech, digital health, medtech, life sciences, and virtual care businesses-on matters relating to regulatory compliance, reimbursement, and customer and partner transactions.

In particular, Bethany counsels clients on privacy and security, healthcare fraud and abuse, corporate matters, commercial deals, and ethical considerations in emerging technology. She enjoys developing creative compliance solutions that fit within the unique contours of each business and has extensive knowledge of HIPAA, privacy-by-design, interoperability, Internet of Things, femtech, AI, and cybersecurity. 

Ashleigh Giovannini, Esq., is Counsel at Nixon Gwilt Law. Her experience in regulatory, provider, and commercial aspects of the industry make her an ideal advisor for healthcare companies desiring a secure path for growth. Her expertise includes corporate transactions, general contract drafting and negotiations, fraud and abuse, corporate and regulatory compliance, provider reimbursement, digital health technology, HIPAA privacy and security, and international data privacy law. 

Additional Resources

• Find out  more about Femtech data privacy here [blog post]
• Catch up on the privacy implications post-Dobbs decision here [5-part video series]
• Watch the Top 3 Privacy Concerns for Digital Health Startups [video]
• Connect with Ashleigh Giovannini, Esq., on LinkedIn
• Connect with Bethany Corbin, Esq. on LinkedIn

Join the Conversation

Are you a healthcare innovator? Tell us what topics and people you’d like us to cover in future episodes:

Decoding Healthcare Innovation on LinkedIn

Decoding Healthcare on Twitter

Follow our daily updates on LinkedIn:

Carrie

Rebecca

About Your Hosts

Carrie Nixon and Rebecca Gwilt are partners at Nixon Gwilt Law, a healthcare innovation law firm exclusively serving Providers, D

What you’ll get out of this episode

Carrie talks with American Telemedicine Association (ATA) Vice President of Public Policy Kyle Zebley about how upcoming laws and policies will impact the future of virtual care.

Listen to Discover:

• What the significance of the new bill, H.R. 4040, that was recently passed by the US House of Representatives, is and its chances of being signed into law
• What this new bill left out with respect to priorities within the telehealth stakeholder community
• How the proposed Medicare Physician Fee Schedule could shape virtual care in 2023
• What kind of movement we’re seeing in all 50 states around telehealth and virtual care policy

About Our Guest

Kyle Zebley is Vice President of Public Policy at the American Telemedicine Association (ATA) and Executive Director of ATA Action. He is working with and on behalf of ATA and ATA Action members and like-minded organizations to eliminate barriers to the expansion of telehealth and ensure patients, providers, and payers can realize the benefits of virtual care.

Previously, Kyle was the Chief of Staff in the Office of Global Affairs (OGA) at the U.S. Department of Health and Human Services (HHS). He collaborated with senior leadership from HHS, the White House and other cabinet departments to develop, advise, and promote U.S. global health policy, including in such policy areas as drug pricing, medical devices, global health security, and non-communicable diseases. Prior to HHS, he worked in Congress as a Legislative Director, leading a legislative team in developing policy and drafting legislation, particularly on matters concerning the House Committee on Ways and Means, the House Committee on the Budget and the House Committee on Education and the Workforce. Kyle started his career in Washington, D.C. as a Research Assistant at Public Opinion Strategies, where he worked on campaign strategies for clients running for U.S. President, U.S. Senate, the U.S. House of Representatives, state governor and state legislatures. Kyle is a sought-after policy expert and is frequently quoted in major media coverage on the topic of telehealth, including the Associated Press, Bloomberg, Kaiser Health News, Modern Healthcare, NPR, and Roll Call. In January 2022, Kyle was named by Politico as one of the “Four Washington players poised to shape digital health in 2022”.

About the American Telemedicine Association
As the only organization completely focused on advancing telehealth, the ATA is committed to ensuring that everyone has access to safe, affordable, and appropriate care when and where they need it, enabling the system to do more good for more people.

Additional Resources

• The American Telemedicine Association: “Telehealth. Is. Health. ATA is working to transform health and care through enhanced, efficient delivery.”
• ATA Action: “ATA Action, the ATA’s affiliated trade organization, is our proactive response to the need for expanded advocacy in 2022 and the years to come. “
• Connect with Kyle on LinkedIn

Join the Conversation

Are you a healthcare innovator? Tell us what topics and people you’d like us to cover in future episodes:

Decoding Healthcare Innovation on LinkedIn

Decoding Healthcare on Twitter

Follow our daily updates on LinkedIn:

Carrie

What you’ll get out of this episode

Guest hosts Reema Taneja, Esq., and Kaitlyn O’Connor, Esq. of Nixon Gwilt Law sit in for a vacationing Carrie and Rebecca in this episode. These veterinary telehealth legal experts (and dog lovers!) talk to Mark Cushing, Founder and CEO of the Animal Policy Group, about the growing market for “TelePet,” which is telehealth for pets.

Listen to this episode to discover:

• How TelePet has evolved over time
• What challenges currently exist
• What need TelePet fills in veterinary care 
• What stakeholders can do to help expand access to TelePet services

About our Guest

Mark Cushing is the Founder & CEO of the Animal Policy Group. A long-time political strategist, government regulatory advisor, corporate executive and former litigator, Mark focuses his advocacy practice on providing high-level strategic advice and services to clients with needs at any level of government, and key trade/industry associations in the U.S., Canada and Mexico.

Since 2004, Mark has specialized in animal health, animal welfare, veterinary and veterinary educational issues and accreditation, developing a cutting-edge practice across these sectors. He currently leads several industry coalitions and initiatives. Mark has guided successful accreditations for a growing list of veterinary colleges, and is co-founder of the Veterinary Virtual Care Association.

Mark has recently penned Pet Nation, a book that tells the inside story of how companion animals are transforming our homes, culture, and economy. Mark is a frequent speaker at veterinary medicine and other animal policy-related conferences.

About the Company

The Animal Policy Group monitors all 50 state Legislatures, Veterinary Medical Boards and Pharmacy Boards 365 days a year. Then they rely on relationships in each state, and industry partners, to implement effective plans for success.

Additional Resources

• Learn more about the Animal Policy Group
• Check out Mark’s book, Pet Nation: The Inside Story of How Companion Animals Are Transforming Our Homes, Culture, and Economy
• Watch Reema and Kaitlyn’s recent webinar on the Top 3 Legal Considerations for TelePet Startups

Join the Conversation

Are you a healthcare innovator? Tell us what topics and people you’d like us to cover in future episodes:

Decoding Healthcare Innovation on LinkedIn

Decoding Healthcare on Twitter

Follow our daily updates on LinkedIn:

Carrie

Rebecca

About Your Hosts

Carrie Nixon and Rebecca Gwilt are partners at Nixon Gwilt Law, a healthcare innovation law firm exclusively serving Providers, Digital Health Companies, and Life Science Businesses seeking to transform the way we receive and experience healthcare. Find out more at NixonGwiltLaw.com. 

What you’ll get out of this episode

Co-host Carrie Nixon talks with Wellbe Founder and CEO James Dias about how to promote how to reduce (or even remove) burdens on providers through technology—which promotes provider buy-in of innovations and better patient results.

Listen to this episode to discover:

• How automated patient care/guidance supports patient-provider partnerships and eases burdens on providers/staff
• How to address labor shortages with technology
• How automating the right aspects of pre- and post-surgery care paths can provide better outcomes for patients with less burden on clinicians

About our Guest

James Dias is the founder and CEO of Wellbe, a health tech company that provides workflow solutions to make the care journey easier and more productive for patients and providers. James believes technology, when creatively applied, can improve life experiences, and he created a business model to reshape personal health management. He is the co-inventor of the Guided CarePath and leads Wellbe’s innovations program to empower people and providers with new tools to improve health.

James is an entrepreneur at heart and has launched several new businesses over his career including the Mediasite lecture recorder, which is the leading video learning appliance in companies and universities around the world.

About the Company

Wellbe’s role is to provide the simplest, most accessible solution so that patients, providers, and healthcare systems can achieve greater outcomes.

ConnectedCare™, Wellbe’s care automation solution, digitally navigates the healthcare journey, resulting in more confident and prepared patients, in reduced burden on clinical staffs, and improved overall health for the healthcare systems and the communities they serve.

Additional Resources

• Find out more about Wellbe
• Connect with James Dias on LinkedIn                        
• Discover how Nixon Gwilt Law helps hospitals and health systems innovate

Join the Conversation

Are you a healthcare innovator? Tell us what topics and people you’d like us to cover in future episodes:

Decoding Healthcare Innovation on LinkedIn

Decoding Healthcare on Twitter

Follow our daily updates on LinkedIn:

Carrie

Rebecca

About Your Hosts

Carrie Nixon and Rebecca Gwilt are partners at Nixon Gwilt Law, a healthcare innovation law firm exclusively serving Providers, Digital Health Companies, and Life Science Businesses seeking to transform the way we receive and experience healthcare. Find out more at NixonGwiltLaw.com. 

What you’ll get out of this episode

Co-host Carrie Nixon chats with healthcare innovation attorney Casey Papp, an expert in the operational and legal nuances of providing virtual care management services within a health system. With McKinsey & Company predicting “up to $265 billion worth of care services for Medicare fee-for-service and Medicare Advantage beneficiaries could shift to the home by 2025,” now is the time to investigate how a Care at Home or Hospital at Home initiative could work for hospitals, health systems, and the vendors who provide mobile services.

Listen to this episode to discover:

• What "Hospital at Home" means in the context of Medicare's program and what the phrase can mean more generally
• What role digital health companies and mobile health companies have to play in a Hospital at Home program
• What both hospitals and digital/mobile health vendors need to consider in implementing a successful Hospital at Home program
• What the future may hold as we shift towards healthcare at home, including acute care

About our Guest

Casey Papp’s experience includes implementing digital health programs for New York-Presbyterian Hospital, where she supported virtual care delivery by more than 4,000 providers, including Hospital at Home, RPM, inpatient consults, tele-lactation, virtual urgent care, specialty video visits, second opinions, and mobile stroke.

Casey’s operational and legal experience—plus her pre-pandemic advocacy of telehealth and innovative care models—make her a strong ally for innovators seeking a place in this growing market. Casey is Senior Counsel at Nixon Gwilt Law and serves as a core member of the Hospitals and Health Systems Practice. Find out more about her work here.

About the Company

Founded in 2016, Nixon Gwilt Law works with innovative Providers, Digital Health Businesses, Life Sciences Businesses, Investors, Startups, and Growth Stage Businesses to improve patient access, options, and health outcomes. Their industry leadership in pricing by client outcomes instead of billable hours, as well as their focus on building integral “thought partner” relationships with their world-changing clients, make Nixon Gwilt Law a top choice for novel and disruptive healthcare and life science companies. 

As a female-founded and female-led firm with a commitment to social justice and diversity, equity, and inclusion (DEI) that guides employee and client recruiting, NGL plans to leave the world a better place. Find out more at nixongwiltlaw.com.

Additional Resources

• Read more about the move to Care at Home
• Discover 5 reasons hospitals and health systems are implementing Hospital at Home
• Find out how Hospital at Home works for facilities, vendors, and patients
• Learn more about Casey’s innovation work with hospitals and health systems
  
  

Join the Conversation

Are you a healthcare innovator? Tell us what topics and people you’d like us to cover in future episodes:

Decoding Healthcare Innovation on LinkedIn

Decoding Healthcare on Twitter

Follow our daily updates on LinkedIn:

Carrie

Rebecca

About Your Hosts

Carrie Nixon and Rebecca Gwilt are partners at

What you’ll get out of this episode:

Cohost Rebecca Gwilt talks with Stix Cofounder Cynthia Plotch about women’s health—an especially timely conversation given the leaked Roe v. Wade decision. Be sure to take our survey (also linked below) to help shape the roundtable we’re hosting this summer with policy makers, advocacy groups, Femtech companies, and telemedicine providers in the reproductive and maternal care space to better chart a unified path forward.

Listen to this episode to discover:

• What it is like to raise money in femtech from investors that are primarily men
• What is it like to build a women's health company, including tips and tricks for others in this space
• How the company’s first emergency contraception product, Relaunch, came to be and the demand, access, and misconceptions around it
• What the leaked Roe v. Wade decisions means for the future of women-centric healthcare companies
• Why Stix decided early on to take a public stand on this issue and how other femtech founders can, too (even if they don’t know how yet) 

About our Guest

Cynthia Plotch, cofounder of Stix, is an Inc 100 Female Founder and a member of Forbes Next 1000. Cynthia and her cofounder are passionate about making sure women have the products, education, and support they need to make confident decisions along their health journeys. The company, which is active in 50 states, offers at home pregnancy, ovulation, UTI, and yeast infection tests and related products. Connect with Cynthia on LinkedIn.

About the Company
Stix provides women with the products, education, and support they need throughout their health journey. Check out the pregnancy and ovulation tests & the Stix Library. Learn more at getstix.co. 

Additional Resources

• Wondering about the impact of that leaked SCOTUS decision? Nixon Gwilt Law is putting together a roundtable discussion this summer for FemTech innovators. We'll explore how to respond to this pending decision for your business and the industry. Want to be part of it? Start by sharing your thoughts in this confidential survey.  
• Be sure to check out episode 21 with Maria Butkovic of Women of Wearables for more on FemTech innovation.
• If you’re not already, be sure to check out our sister podcast, Legally Femtech, hosted by Bethany Corbin, Esq., who will continue covering these developments.

Coming Up

We’ve got a sizzling summer on the way with topics on virtual consultations for pharmacists, care at home initiatives, and much more on FemTech and data privacy. Don’t miss an episode!

Join the Conversation

Are you a healthcare innovator? Tell us what topics and people you’d like us to cover in future episodes:

Decoding Healthcare Innovation on LinkedIn

Decoding Healthcare on Twitter

Follow our daily updates on LinkedIn:

Carrie

Rebecca

About Your Hosts

Carrie Nixon and Rebecca Gwilt are partners at Nixon Gwilt Law, a healthcare innovation law firm exclusively serving Providers, Digital Health Companies, and Life Science Businesses seeking to transform the way we receive and experience healthcare. Find out more at

What you’ll get out of this episode

In this episode, Carrie Nixon talks with husband and wife team, Mark and Kristen Engelen, co-founders of RxLive, a digital health company that re-imagines the role of pharmacists through virtual consultations with patients of value-based care delivery organizations. 

Listen to discover:

• How pharmacists can play a critical role in reducing the burden on primary care physicians who are managing the care of chronic disease patients
• Why value-based entities are the ideal partners for RxLive
• What role drug pricing transparency plays in pharmacists' ability to help manage high spend on drugs.

About our Guests

Kristen Engelen, PharmD, Chief Pharmacy Officer, Co-founder Kristen is an experienced retail pharmacist, having worked for multiple national chains including Target, Kroger and Walgreens. She has a background in and passion for clinical geriatric pharmacy and is a licensed consultant pharmacist. Kristen received her Doctor of Pharmacy degree from the University of North Carolina’s Eshelman School of Pharmacy, where she graduated with distinction.

Mark Engelen, Chief Executive Officer, Co-founder Mark is a marketing, strategy and product executive with experience across multiple healthcare verticals including Healthcare IT, PBMs, public policy, and retail pharmacy. Mark has an MBA from the Harvard Business School and degrees in Economics and Chemistry from the University of North Carolina at Chapel Hill.

About the Company

RxLive is a nationwide telehealth platform of clinical pharmacists delivering concierge medication counseling to provider’s patients, employer groups, and consumers. We work with progressive healthcare organizations, employers and payers to integrate pharmacists into the collaborative care team process resulting in improved outcomes and reduced costs. Our service requires no up-front capital expenditures and delivers a value-added program at a zero-net cost. A hallmark of our process is a focus on motivational interviewing, relationship building and solving the social determinants of non-compliance. Services include:  In-depth pharmacist counseling over video chat or phone,  Pharmacogenomic testing with pharmacist consultations,  Pharmacist integration into PCMH, CPC+, MSSP and MIPS programs, Post Discharge Medication Reconciliation, Specialty pharmacy cost management, and Medication counseling for employees and their extended families.

Additional Resources

• Key areas to check before adding telepharmacy to your business model
• Connect with Kristen on LinkedIn
• Connect with Mark on LinkedIn
• Learn more about RxLive

Join the Conversation

Are you a healthcare innovator? Tell us what topics and people you’d like us to cover in future episodes:

– Website – LinkedIn – Twitter – Instagram – YouTube

Follow our daily updates on LinkedIn:

Carrie

Rebecca

About Your Hosts

Carrie Nixon and Rebecca Gwilt are partne

What you’ll get out of this episode

In this episode, Rebecca Gwilt talks with Liz Powell from G2G Consulting. Liz has joined Rebecca to talk about a few things that digital health companies might not have on their radar, but which can be transformative for their success, such as raising non-dilutive funding and why it's important to have a policy/government strategy, even as a startup.

Listen to discover:

• Why it is important to shape health policy
• Where to look for untapped resources to access funding for entrepreneurs and growing businesses
• Why we need to address women’s health gaps and create a better ecosystem to support related health innovation

About our Guest

Liz has over 20 years of experience as policy staff on Capitol Hill, attorney and lobbyist. Since starting G2G in 2007, G2G has raised $413 million in non-dilutive funding for clients (many in health innovation), shaped regulations and policies, and organized advocacy campaigns. Liz previously served as Legislative Director on Capitol Hill, congressional and presidential campaign staff, Public Affairs Manager for a national health association, and Policy Analyst for the UK Parliament’s Health Committee. She helped launch the Women’s Health Innovation Coalition in 2020 and co-founded the Harvard Chan School of Public Health Alumni DC Chapter. She earned her MPH from Harvard, JD from George Washington, and BA from Colgate. 

About the Company

G2G is a bipartisan team of non-dilutive funding experts and government affairs professionals who have spent decades working for and with government on the federal, state and local levels – successfully representing bioscience, healthcare, and high-tech innovators, entrepreneurs, research institutions, companies and nonprofits in securing $413 million in non-dilutive government funding.

                        
Additional Resources

• Connect with Liz on LinkedIn
• Learn more about G2G Consulting

Join the Conversation

Are you a digital health or health system innovator? Tell us what topics and people you’d like us to cover in future episodes:

– Website – LinkedIn – Twitter – Instagram – YouTube

Follow our daily updates on LinkedIn:
– Carrie – Rebecca

About Your Hosts

Carrie Nixon and Rebecca Gwilt are partners at Nixon Gwilt Law, a healthcare innovation law firm exclusively serving Providers, Digital Health Companies, and Life Science Businesses seeking to transform the way we receive and experience healthcare. Find out more at NixonGwiltLaw.com. 

This podcast is produced by Slice of Healthcare LLC.