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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 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:

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.

Trending in Telehealth: August 1 – 7, 2023

by Patrick Zanayed and Abby Higgins | Aug 14, 2023 | Telehealth

Trending in the past week:

Professional Practice Standards

A CLOSER LOOK
Finalized Legislation & Rulemaking

A law creating the Continuum of Care Program in Arkansas went into effect on July 31, 2023, permitting care coordination of certain reproductive health services to be conducted via telemedicine.
Illinois updated the Hearing Instrument Act, allowing patients 18 years or older to be evaluated for a hearing aid prescription via telehealth. Patients who are 17 years or younger still must have an in-person visit to obtain a prescription. These updates are not effective until January 1, 2024.
The Medical Care Program in Maryland adopted updated standards for physical therapy services provided via telehealth. This update generally aligns those requirements with broader telehealth standards in the state.
Massachusetts passed an emergency rule permitting mobile crisis intervention care to be provided via telehealth and still be eligible for reimbursement under government health care programs. These emergency measures went into effect on August 1, 2023, and will be made permanent pending federal approval.
Oklahoma revised the standards surrounding community mental health centers (CMHCs) and certified community behavioral health clinics to add telehealth encounters to the definition of “face to face” visits. This term is used to determine psychotherapy or therapy services provided by CMHCs, which provide certain assessments and emergency services throughout the community.
The Kentucky Board of Optometric Examiners updated telehealth standards for optometrists, including regulations permitting the provision of services by optometrists physically located outside of Kentucky, via telehealth in certain situations.
Kentucky also passed an emergency rule to address the shortage of social workers. Unlike optometrists, social workers must be physically located within the Commonwealth to use telehealth to care for Kentucky patients.
Texas passed an amendment to the physical therapy practice standards for early childhood intervention care, which permits certain previously onsite-only care to be conducted via telehealth.
New standards related to the use of telemedicine within the practice of occupational therapy in Wisconsin have gone into effect as of August 1, 2023. To note, the initial regulations proposed were not fully accepted, the Wisconsin Occupational Therapists Affiliated Credentialing Board adjusted the regulations after the public comments.

Legislation & Rulemaking Activity in Proposal Phase
Highlights:

(more…)

In Case You Missed It: Highlights | When Digital and Life Sciences Intersect

by McDermott Will & Emery | Aug 8, 2023 | Uncategorized

In this session, panelists discussed common pitfalls that life sciences companies face as they explore ways to incorporate digital-health strategies into product and service offerings, as well as approaches for successful integration and launch. Seasoned veterans in developing and deploying digital-health solutions from within the life sciences ecosystem, the panelists shared lessons learned and offered practical suggestions for listeners addressing similar projects.

Session panelists:

David S. Klimstra, MD, Founder and Chief Medical Officer, Paige.AI, Inc.
Suhas Krishna, Vice President, Head of Product Management, Digital Health, Bristol Myers Squibb
Betsy McSheffrey, Head Counsel, Data, Technology and Innovation, Takeda
John Rootenberg, MD, Principal Director, Digital Safety and Decision Support, Genentech (Roche)
Ryan Sysko, Chief Executive Officer, Amalgam RX
Moderator: Jennifer Geetter, Partner, McDermott Will & Emery

Top takeaways included:

Challenges

Last-mile conundrum. Panelists observed that for typical products manufactured by life sciences companies, a disproportionate amount of the hard work occurs prior to regulatory approval. Once the product is approved (by, for example, the Clinical Laboratory Improvement Amendments (CLIA) or the US Food & Drug Administration (FDA), the company’s most difficult work is done. For digital-health solutions, the inverse is often true. Even sophisticated digital-health products and services typically have a shorter development timeline, but once released in the market, challenges around adoption, adherence, persistence and integration must be addressed. In addition, customers will expect regular software updates. Life sciences companies are not always adequately prepared for this reverse last mile—i.e., the longest mile—of the development and marketing lifecycle.
Risk appetite. Panelists noted that the life sciences industry is typically risk averse. This is in sharp contrast, for example, to the software industry, which is attuned to software innovations and is designed to anticipate missteps and optimize, when necessary, the “fast fail.”
Blurry strategic vision. The panelists discussed “digital-health FOMO” (fear of missing out). Life sciences companies want to offer digital-health products and services because they recognize the strategic value of participating in the market explosion at the intersection of healthcare and data/computing. Sometimes this enthusiasm outpaces the speed with which life sciences companies can develop dedicated digital-health strategies, either as companions to existing products or as complimentary clinical services. Having a clear strategic objective governing the development of a product and realistic investment goals are critical.
Deployment. The panelists emphasized that once a digital health tool is developed, companies should ensure physicians and patients actually adopt and continue to use the tool. Specifically, one panelist stated, “The one who wins is the one who has the right deployment [of the tool].”

Opportunities

Hidden value. Digital-health strategies, such as using the data obtained from digital-health tools to promote research, offer hidden value for life science companies. As a component of development and marketing strategy, life sciences companies need to be prepared to articulate these benefits, especially those that may not be readily apparent or may be ancillary benefits. The successful deployment of a digital-health tool—for example, a patient- or consumer-facing app—is predicated on the persistent adoption of [...]

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Trending in Telehealth: July 25 – 31, 2023

by Amanda Enyeart and Grayson Dimick | Aug 4, 2023 | Telehealth

Trending in the past week:

Professional Practice Standards

A CLOSER LOOK

Finalized Legislation and Rulemaking

Nevada finalized a rule that updates its physical therapy standards. Physical therapists may now provide services via telehealth in accordance with Nevada’s general telehealth statute, Nev. Rev. Stat. § 629.515.
Legislation and Rulemaking Activity in Proposal Phase

Highlights:

Texas proposed a rule that would amend Division of Workers’ Compensation regulations that set telehealth and telemedicine billing requirements for services provided to injured employees in the Texas workers’ compensation system. The proposed rule would add a definition for “teledentistry services” and would add Medicaid payment policies to the list of applicable payment policies that healthcare providers must use to bill for telemedicine, telehealth and teledentistry services.
West Virginia’s Medical Imaging and Radiation Therapy Technology Board of Examiners proposed a rule that would clarify that telehealth practice is inapplicable to the performance of medical imaging and radiation therapy. This proposed rule comes in response to W.V. Code § 30-1-26, which requires all health boards to adopt rules governing telehealth.

Why it matters:

States continue to refine and adopt professional practice standards for telehealth. Some states have recently adopted new or revised professional practice standards that vigorously regulate telehealth. As the latest Nevada and West Virginia rules demonstrate, regulation for certain health professions may be less robust and may simply clarify whether the profession is permitted to practice via telehealth.

Telehealth is an important development in care delivery, but the regulatory patchwork is complicated. The McDermott digital health team works alongside the industry’s leading providers, payors and technology innovators to help them enter new markets, break down barriers to delivering accessible care and mitigate enforcement risk through proactive compliance. Are you working to make healthcare more accessible through telehealth? Let us help you transform telehealth.

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