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Key Takeaways | What the Money Thinks: Investing in Innovative Care Delivery

by McDermott Will & Emery | Sep 19, 2023 | Uncategorized

During this session, digital health investors and finance experts discussed the trends they are watching in today’s market. The group also shared ideas on how companies can stand out from their competitors in the bid for limited investor dollars, and the role of venture capital and venture capital-backed companies in solving today’s healthcare challenges.

Session panelists:

Bill Evans, Founder and General Partner, Rock Health
Anna Fagin, Principal, Town Hall Ventures
Adam Heller, Managing Director, Healthcare Investment Banking, Ziegler Healthcare Investment Banking
Fazeela Abdul Rashid, Partner, Revolution Growth
Moderator: Dale Van Demark, Partner, McDermott Will & Emery

Top takeaways included:

The COVID-19 pandemic accelerated the adoption of digital health, and while digital healthcare delivery is here to stay, some correction in the market is expected. While the healthcare system was moving towards digital health due to technological advances, the COVID-19 pandemic accelerated patients’ and providers’ wiliness to utilize technology. This increased utilization has provided tangible evidence that digital health solutions have real efficacy, clinical quality, and can help lower costs and bring better, more efficient outcomes. At the same time, the COVID-19 pandemic distorted the market, as providers had no choice but to supply care virtually, and there was abundant capital for startups. As the pandemic unwinds and the market tightens, the panelists expect to see correction in the market.
In this constrained capital market, successful digital health companies are those that can demonstrate they are self-sustaining, able to be a long-term solution and can add value. Investment funds have been funneled towards operating and managing portfolio companies, with fewer new investments as a result. With this in mind, new entrepreneurs in the digital health ecosystem need to demonstrate that they can make a core, clear difference, adding true efficiency to the healthcare system and demonstrating where their value resides.
Digital health tools can address inequities in the health care system—but not every solution addressing inequity is venture-backable. There is a tremendous opportunity for digital health tools to address inequity if founders and investors are willing to ask hard questions and commit to addressing inequity as part of their goals. Returns can be equipped by mission, rather than acting in conflict with the mission. However, not every business that can affect outcomes is designed for scale and is venture-backable. The panelists agreed that it is okay that not everything is venture-backable—there are many ways to fund a business and many issues in the healthcare system that require different stakeholders.
For ventures that are looking for capital right now, focus on finding the right partners and demonstrating value. The panelists recognized that it is a difficult time for ventures that are looking for funding, but urged companies not to give up if they have something unique and visionary. Even in this market, the panelists agreed that finding the right partner is key—the relationship must work in both directions and align with the venture’s vision. The panelists also advised that successful ventures that will be those that can achieve early, [...]

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Key Takeaways | Hospital and Health System Digital Health Spotlight: It’s all About the Patient!

by McDermott Will & Emery | Sep 14, 2023 | Uncategorized

During this session, leaders from health systems and digital health technology companies explored how they are leveraging their prowess to develop cutting-edge strategies to deliver accessible, easy to use and secure digital health solutions that work together seamlessly across the healthcare ecosystem and patient journey.

Session panelists:

Erica Davila, general counsel, Transcarent
Daniel Gottlieb, partner, McDermott Will & Emery
Nathan Leong, vice president, legal, Memora Health
Sudipto Srivastava, vice president, digital transformation, Hospital for Special Surgery
Paul Uhrig, senior vice president, chief legal officer and digital health officer, Basset Healthcare Network
Moderator: Bernadette Broccolo, partner, McDermott Will & Emery

Top takeaways included:

The patient relationship is the cornerstone of any patient engagement strategy. Most, if not all, of the panelists agreed with this statement, yet they also recognize that the consumer and patient engagement solutions flooding the digital health ecosystem have cast doubt as to where the primary patient relationship should reside. For health systems, there is no doubt—they are and must remain a central, trusted partner for delivery and coordination of care across a patient’s healthcare journey. In their quest to do so, health systems are aggressively pursuing strategies that combine digital and in person touchpoints to engage individuals, both as consumers and as patients, “where they are” so they can get them to the right healthcare, at the right place and at the right time. While many digital health technology solution companies pursued “direct-to-patient” offerings early on, some quickly recognized the complexities of that model and shifted their primary focus to becoming an “extension” of health systems and payors by providing the turnkey technology infrastructure and support services they need to remain the “front door” for healthcare for patients and consumers.
Patients, providers and self-funded health plans want a seamless, integrated and holistic digital engagement experience. Digital engagement solutions and the data strategies supporting them have been highly fragmented and lacking integration across the patient journey and healthcare ecosystem. This is due largely to their multiple points of entry into disconnected “point-to-point solutions,” which is particularly challenging for poly-chronic patients. Providers and their patients, and self funded health plans and their members, are frustrated and clamoring for single sign on platforms through which they can engage seamlessly, in a single encounter, with digital health applications and data sources. Health systems, in particular, are looking to “fill the white space” in functionality existing between inflexible electronic health record (EHR) systems that rely exclusively on traditional patient identifiers and less formal point to point digital health solutions. Individual providers want solutions that will alleviate the burden and stress of today’s technology tools. And everyone wants an approach that brings a holistic rather than an episodic experience.
It will “take a village” to achieve seamless, integrated and holistic digital health engagement. No single stakeholder in the digital health ecosystem has the solution for overcoming the frustrating fragmentation of digital health engagement solutions. There certainly is no “one-size-fits-all” approach. Health systems, payors and digital health turnkey solution providers are [...]

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Trending in Telehealth: August 29 – September 5, 2023

by Dale C. Van Demark and Jayda Greco | Sep 8, 2023 | Telehealth

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate the delivery of virtual care.

Trending in the past week:

Medicaid Reimbursement of Behavioral Health Services
Practice Standards for Counselors and Therapists
Technology and EHR access

A CLOSER LOOK

Finalized Legislation and Rulemaking

West Virginia enacted emergency rulemaking, effective October 12, 2023, that establishes the scope of practice for the provision of counseling services via telehealth technologies and the process for licensed professional counselors or licensed marriage and family therapists to obtain an interstate telehealth registration with the West Virginia Board of Examiners in Counseling. This rule ensures continuity of care while existing patients are either transitioning to become a resident of another jurisdiction or temporarily located in another jurisdiction.
Washington, DC, adopted an emergency rule, effective September 1, 2023, that reimburses the use of audiovisual telehealth visits in the Assertive Community Treatment (ACT) program within DC Medicaid.
Mississippi finalized rulemaking, effective October 1, 2023, regarding Medicaid coverage for continuous glucose monitoring services via telemedicine.
Oklahoma finalized rulemaking, effective September 11, 2023, that allows for onsite and mobile crisis intervention services to be provided in person or via telehealth.

Legislation and Rulemaking Activity in Proposal Phase

Highlights:

California’s state legislature presented AB 1241 to the governor on August 30, 2023. If signed, the bill will loosen certain requirements related to the virtual delivery of care within the Medi-Cal program. Existing law requires providers that furnish services through video synchronous interaction or audio-only synchronous interaction to also either offer those services in person or arrange for a referral to, and a facilitation of, in-person care. That requirement will go into effect by a date set by the State Department of Health Care Services, but no sooner than January 1, 2024. Under AB 1241, providers will instead be required, in the above-described circumstance, to maintain protocols for patient referral to appropriate in-person care when the standard of care cannot be met by video synchronous interaction or audio-only synchronous interaction.
California’s state legislature progressed AB 965.The bill is an amendment to the Permit Streamlining Act that would require local agencies that process applications for the construction of broadband projects to simultaneously process multiple broadband permit applications for substantially similar projects under a single permit (so-called “batch broadband permit processing”), with the goal of a more efficient broadband approval process.
California also progressed AB 1369 to the Second Committee. This legislation provides that a person licensed as a physician and surgeon in another state would be authorized to deliver healthcare via telehealth to a patient who, among other requirements, has a disease or condition in which there is a reasonable likelihood of death within a matter of months.
Alaska proposed rulemaking to [...]

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Key Takeaways | Playing the Long Game: Investor Outlook on Late-Stage Funding

by McDermott Will & Emery | Sep 5, 2023 | Uncategorized

During this session, panelists discussed what strategic and late-stage investors are looking for in today’s market, offered practical tips on how to make organizations attractive to investors, and described innovative funding arrangements for use during tough times.

Session panelists:

Julie Ebert, Managing Director, Silicon Valley Bank
Adam Kaye, Managing Director, Sixth Street
Noah Lewis, Managing Partner, Ardan Equity
Irem Rami, Principal, Norwest Venture Partners
Moderator: Thaddeus E. Chase, Jr., Partner, McDermott Will & Emery

Top takeaways included:

The days of funding growth at all costs are over, particularly for late-stage businesses. Investors are looking for strong unit economics at the gross-margin level, proven return on investment, customer retention and product-market fit.
Consolidation and other M&A activities may be the best plays for late-stage companies in this market. Investors are skeptical of soaring valuations and customers have been overwhelmed with point solutions over the last few years. Strategic and other late-stage investors are focused on consolidation opportunities.
Companies should build for profitability, not for exit opportunities. For example, instead of launching with a national sales strategy, companies should focus on proving return on investment (ROI) in one or two markets before expanding, noting, “Slow is smooth, and smooth is fast.”
Although investment activity has been slower over the past year, investments are expected to pick up again during the next 12 to 24 months. The panelists were most bullish on life sciences, followed by payor solutions, then provider solutions.

Trending in Telehealth: August 22 – 28, 2023

by Stacey Callaghan and Abby Higgins | Aug 30, 2023 | Telehealth

Trending in the past week:

Update to Standards of Care
Youth Programs

A CLOSER LOOK

Finalized Legislation and Rulemaking

Louisiana finalized regulations (beginning on page 21) related to Early and Periodic Screening, Diagnosis and Treatment (EPSDT). The regulations exclude telemedicine as a covered service for consultations but do state that telemedicine is an “applicable service method.” Specifically, the new regulations state that “[w]hen otherwise covered by Louisiana Medicaid, telemedicine/telehealth is allowed for all CPT codes located in Appendix P of the CPT manual. This service is available to all Medicaid individuals eligible for EPSDT.”
Ohio adopted rules related to the use of telehealth by Ohio State Chiropractic Board licensees, amending the practice guidelines for chiropractors in the state. This update includes information on approved modalities, allowing the use of both synchronous and asynchronous technologies. This new rule also explicitly states that an Ohio license is required for practicing within the state.

Legislation and Rulemaking Activity in Proposal Phase

Highlights:

California’s state legislature has passed AB 1241, which relates to the Medi-Cal program. Existing law requires providers furnishing services through video synchronous interaction or audio-only synchronous interaction to also either offer those services in-person or arrange for a referral to and facilitation of in-person care by a date set by the department, but no sooner than January 1, 2024. AB 1241 would instead require a provider to maintain protocols for patient referral to appropriate in-person care when the standard of care cannot be met by video synchronous interaction or audio-only synchronous interaction. This has passed both houses of the California State Legislature, with amendments being accepted by the California State Assembly on August 24, 2023. It now heads to the governor.
Florida has proposed an amendment to the registration regulations for out-of-state providers providing care via telehealth. While not incredibly substantive, the amendment updates the application that out-of-state providers must submit to practice within the state. The updated application is not yet available.
Louisiana has proposed changes (beginning on page 143) to certain regulations related to the provision of care to School-Based Health Centers (SBHCs). This includes a proposed regulation for SBHCs to provide convenient access to preventive and acute care services for students who might otherwise have limited or no access to healthcare, including through telehealth.
New Jersey has proposed adding definitions to regulations related to the home health standards of care for telehealth and telemedicine in order to keep abreast with newer technology. Specifically, the amended N.J.A.C. 8:42-6.7 would permit the telehealth services to be offered in addition to, but not in lieu of, direct patient care.
Tennessee has a fast-moving bill that has passed the state senate and [...]

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Key Takeaways | Innovative Partnerships in Action: Fireside Chat with Covera Health and Nuance Communications

by McDermott Will & Emery | Aug 29, 2023 | Uncategorized

During this session, leaders from Covera Health and Nuance Communications provided insights into their companies’ collaboration to improve patient outcomes and operational efficiency through innovative technology solutions. The panelists also shared their perspectives on what makes for a successful collaboration in digital health. The discussion shed light on broader trends surrounding novel strategic partnerships between digital health companies that are changing healthcare delivery and accelerating value-based care.

Session panelists:

Jacques Gilbert, Vice President, Healthcare Strategy, Partnerships and M&A, Nuance Communications
Ron Vianu, Founder and Chief Executive Officer, Covera Health
Moderator: Jiayan Chen, Partner, McDermott Will & Emer

Top takeaways included:

Covera and Nuance decided to partner because they were aligned on solving the same problem: longstanding challenges in driving quality in radiology care and aligning incentives among payor and provider stakeholders. The collaboration made particular sense because each company has a unique lens and business model in the space, with Covera building offerings for payors and Nuance interfacing with radiology providers. Both companies are also highly technologically driven, committed to advancing healthcare quality through artificial intelligence (AI) and deriving insights through data.
While “collaboration” and “partnership” are used quite liberally in the digital health context, Covera and Nuance have a truly integrated partnership that requires alignment, shared vision, tenacity and a willingness to overcome challenges. This is not a vendor/provider relationship or merely a cross-selling or cross-promotion arrangement. Each party brings a unique set of tools, strengths and relationships to the table, whether it is dexterity in the managed care space or a wide network of integrated technology and data platforms used by providers. Overcoming challenges in this kind of partnership requires the teams—at even the highest levels—to align around a common goal and a belief that they can accomplish the goal. When they run into areas of conflict, that fundamental alignment allows them to move forward and find solutions.
Some of the biggest barriers for technology-driven partnerships can come from each team’s desire to build and own the technology. Overcoming these barriers requires constant focus on the collective goals of the partnership and for each party to engage in ongoing internal reflection and calibration.
There can be particular challenges when one party is a startup and the other is an established, larger company. For a startup, it can be difficult to scale the company while simultaneously collaborating with a much larger company that, for its part, must manage more extensive and varied strategic goals. In turn, larger companies often must be sensitive to the fact that a startup partner can be built to move quickly and is positioning itself for growth and potential future acquisition. To better navigate these differences, the larger company could consider carving innovation opportunities out of its core business and staffing it with people who understand how startups operate.
There’s an increasing recognition that the path to success is through partnerships. For companies looking to enter partnerships, understanding each party’s incentives is crucial. This concept goes beyond the partnering companies and includes [...]

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Trending in Telehealth: August 15 – 21, 2023

by Purnima Boominathan and Abby Higgins | Aug 25, 2023 | Telehealth

Trending in the past week:

Expansion of Telehealth Services
Broadband Access
Clarity on Supervision Requirements

A CLOSER LOOK

Finalized Legislation and Rulemaking

Colorado moved, but did not amend or modify, the supervising requirements for physician supervisors to 3 CCR 713-1 Rule 1.15 .
The District of Columbia finalized and adopted rules for the practice of professional art therapy, addressing practice standards and licensure relating to the use of telehealth in this area of practice.
Maryland finalized a rule related to participation in the Medicaid program for podiatrists, which includes required compliance with telehealth regulations. Maryland also finalized regulations related to home care for disabled children, allowing care to be provided, under certain circumstances, through “audio-visual telehealth” in accordance with other Maryland telehealth requirements.
New Hampshire’s governor signed a bill that provides an exception to New Hampshire licensing requirements for out-of-state healthcare professionals treating patients in the custody of the state’s department of corrections, provided the out-of-state healthcare professionals are licensed, certified or registered by and are in good standing with the appropriate licensing body within the professional’s state of practice. The bill goes into effect on October 7, 2023.
New Hampshire also amended an existing parentage-related law to permit a mental health consultation to be conducted via telehealth. This amendment went into effect on August 19, 2023.
Oklahoma adopted emergency regulations related to reimbursement by the state Medicaid program, including a new section for definitions and standards for audio-only health services.
Oregon permanently repealed a rule addressing COVID-19 workplace risks, which in part included telehealth information. This rule had previously been temporarily suspended, so no significant impact is expected.
South Dakota adopted changes to the licensure regulations for speech-language pathologists, which removes the definition of “telepractice.” The rule now refers to the definitions section of South Dakota codified laws §36-37-1 and §36-37-2.
Tennessee finalized rules related to healthcare facility licensing, specifically requiring rural emergency hospitals to include a description of additional services provided within the licensing application, citing telehealth services as an example of additional services to be included.
Texas amended the telemedicine, telehealth and teledentistry rule (§133.30) within the Texas Administrative Code. The amended section implements §413.011 of the state’s Labor Code, which requires the Texas Department of Insurance to adopt healthcare reimbursement policies and guidelines related to workers’ compensation that reflect the standardized reimbursement structures found in other healthcare delivery systems. Interestingly, §413.011 requires the commissioner of workers’ compensation to adopt the current reimbursement methodologies, models and values or weights used by the federal Centers for Medicare & Medicaid Services.
Washington finalized two rules [...]

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Top Takeaways | 2023 Digital Health Forum | Innovative Partnerships in Action: Fireside Chat with Best Buy and Atrium Health, a part of Advocate Health

by McDermott Will & Emery | Aug 22, 2023 | Uncategorized

In this lively and practical conversation, panelists elaborated on the recently announced partnership between Atrium Health, a part of Advocate Health (Atrium), and Best Buy Health. The partnership is designed to leverage technology, empathy and expertise to deliver high-quality care in the home following patients’ transition to a hospital-at-home program.

Session panelists included:

Deborah Di Sanzo, President, Best Buy Health
Rasu Shrestha, MD, MBA, Executive Vice President, Chief Innovation and Commercialization Officer, Advocate Health
Moderator: Stephen Bernstein, Partner-In-Charge of Healthcare Practice Operations, McDermott Will & Emery

Top takeaways included:

Partnership focus. Atrium, one of the largest academic medical systems in the United States, partnered with Best Buy Health to improve care delivery in the home. The partnership is aimed at creating smoother paths for care, shifting from episodic brick and mortar treatment to care in the home.
Trust and diligence. The partnership between Atrium Health and Best Buy Health was the culmination of two years of discussions. Trust, communication with common purposes and measurable outcome goals were identified as crucial factors in establishing successful partnerships in healthcare.
Offering and collaboration. The partnership aims to combine Best Buy’s technological expertise, including the remote patient monitoring (RPM) platform from Current Health, with Atrium’s cutting-edge clinical protocols and hospital-at-home (H@H) program. The collaboration focuses on improving the patient care experience and automating processes to identify and enroll suitable candidates for H@H programs.
Geek Squad involvement. Best Buy’s Geek Squad plays a role in ensuring the functionality of devices used in home care. Geek Squad’s responsibilities in the partnership parallel its traditional role with Best Buy and include setting up and maintaining the devices when patients are discharged from the hospital and offering customer service and troubleshooting tips.
Impact and growth. The partnership also addresses capacity issues and drives the growth and expansion of H@H programs. By treating patients at home, the program is seeing signs of successfully freeing up intensive-care unit (ICU) and operating-room resources while still monitoring and treating patients effectively. The collaboration between social workers and nurses in home care, combined with the technological expertise of Geek Squad, is beginning to provide evidence of improved quality of care and patient outcomes, with services being delivered in this manner to some of the most ill patients with multiple chronic conditions.
Best Buy and Advocate/Atrium are continuing to monitor progress of this joint effort.

Trending in Telehealth: August 8 – 14, 2023

by Lisa Mazur and Abby Higgins | Aug 17, 2023 | Telehealth

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate the delivery of virtual care.

Trending in the past week:

Expansion of Telehealth Services
Jurisdictional Clarifications for Providers

A CLOSER LOOK
Finalized Legislation and Rulemaking

Maryland amended the requirements for participation in the state’s medical assistance program for advanced practice registered nurses to explicitly require compliance with the state’s telehealth rule in COMAR 10.09.49.
Oregon has finalized a rule related to the licensing of optometrists in either a public health emergency or state emergency, incorporating telehealth licenses into the relevant provisions.
Wisconsin adopted regulations that would expand reimbursement under the state’s medical assistance program for certain services provided via telehealth. This rule, which focuses on mobile crisis units, is a result of a directive by the Wisconsin legislature to determine which services provided via telehealth should be reimbursed under the medical assistance program. This was only a partial adoption of rules proposed earlier this year.

Legislation and Rulemaking Activity in Proposal Phase
Highlights:

Illinois has proposed a rule (page 234) that expands and clarifies the definition of telemedicine in the context of hospital licensing to include provider-to-provider consultations with physicians licensed in the United States.
Illinois has also signed into law its enrollment into the Counseling Compact through an amendment to the Professional Counselor and Clinical Professional Counselor Licensing and Practice Act. Illinois joins more than 30 other states that are part of this intrastate compact.
Massachusetts has proposed regulations related to the provision of doula services, which includes defining the standard of care in terms of telehealth.
West Virginia has proposed regulations (page 20) for best practices related to the provision of sexual assault care. This includes providing the initial evaluation via a telehealth service called teleSANE, which would require additional training for relevant providers.

Why it matters:

States are expanding services that can be provided via telehealth. States continue to identify new service areas in which telehealth can be utilized. Examples include the newly proposed bills related to sexual assault examinations in West Virginia and doula services in Massachusetts. As telehealth has become more common, states have expanded opportunities for telehealth services into more specialized fields.
Jurisdictional questions are being more clearly defined in state regulations. Some states have recently provided clarification for providers who are not physically present in the state, clearing up questions regarding what it means to be practicing within a state. For example, although only applicable in an emergency, the Oregon optometry licensing change specifically addresses physical location. Additionally, Illinois’s enrollment in the Counseling Compact expands and standardizes out-of-state practice for certain provider types.

Telehealth is an important development in care delivery, but the regulatory patchwork is complicated. The McDermott digital health team works alongside the [...]

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Key Takeaways | CEO and Founder Perspective: Provider Spotlight

by McDermott Will & Emery | Aug 15, 2023 | Uncategorized

During this session, CEOs and founders of transformative digital-health companies shared their experiences and offered thoughts on today’s market and where care delivery is heading next.

Session panelists:

Priyanka Jain, Chief Executive Officer and Co-Founder, Evvy
Naveen Kathuria, Chief Executive Officer, GoCheck Kids
Kristina Saffran, Chief Executive Officer and Co-Founder, Equip
Moderator: Marshall E. Jackson, Jr., Partner, McDermott Will & Emery

Top takeaways included:

Virtual-care platforms and digital-health technologies continue to reduce barriers by bringing care directly into the home and expanding access to culturally competent care.
Digital-health tools help increase provider access to data and inform patients about new research findings and other relevant developments they may wish to raise with providers during care visits.
Advances in women’s health continue to lag, but digital-health providers are closing the gap by using enhanced data collection and analysis to develop new care pathways designed specifically for women.
Patient and provider education is critical to the successful adoption and use of digital-health tools. However, choice of technology impacts adoption and continued use of digital-health platforms. For example, the leveraging of smartphones that providers and patients are already accustomed to using may yield greater results, as compared to the use of unique or custom devices that require training to use correctly.
Market focus is shifting from access to quality. As economic conditions change, digital-health platforms that seek new funding will face pressure to prove that their offerings not only increase access, but actually improve outcomes.

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