OF DIGITAL INTEREST
OF DIGITAL INTEREST
Legal news and analysis of all things digital
OF DIGITAL INTEREST
Legal news and analysis of all things digital
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Top Takeaways | 2023 Digital Health Forum | Behavioral Health 2.0: Post-Pandemic Priorities

by | Aug 1, 2023 |

In this session, the panel discussed the opportunities digital health offers currently for behavioral-health care, and what might be around the corner.

Session panelists included:

  • Robert Hasty, General Counsel, Pelago (formerly Quit Genius)
  • Tiffany Lin, Co-Founder and Chief Executive Officer, Daylight Health
  • William Robinson, Head of Policy and Strategy, Big Health
  • Moderator: James A. Cannatti III, Partner, McDermott Will & Emery

Top takeaways included:

  • Accessing quality care. Digital health—including the technology itself and the care models based on it—has become a valuable addition to the healthcare ecosystem, offering increased access to critical behavioral-health care through, for example, 24/7 chat services, that otherwise may be out of reach for patients, especially for those in rural and marginalized communities. It also has played a significant role in destigmatizing behavioral health by breaking down barriers to treatment and providing platforms for individuals to seek support in convenient settings.
  • Filling the gap. The shortage of clinicians has contributed to a tangible absence of specialty behavioral health providers. One example, pediatric psychiatry, continues to have a high demand but, unfortunately, many patients are met with a low supply of clinicians. Digital health helps fill an important gap in providing access to behavioral-health care.
  • Hybrid treatment options. Implementing a hybrid treatment model that incorporates digital and in-person touchpoints can optimize scalability in digital healthcare. A hub-and-spoke model, in which digital tools are embedded within existing systems, offers a balance between prioritizing patients’ needs to receive care in a comfortable setting and the importance of assessing and referring individuals with more serious conditions to appropriate outpatient or inpatient programs.
  • Across the pond. In markets such as the United Kingdom, the National Health Service (NHS) has actively explored and adopted digital-health solutions to enhance patient care and streamline healthcare delivery. In many cases, patients have access to digital-first mental health services at no cost to them. Lessons learned from the UK and other markets may help shape future approaches to digital behavioral health in the United States.
  • Reimbursement landscape. Coverage and reimbursement often lags behind the science. This is particularly true regarding digital behavioral health. Finding market strategies that allow for patients to access care is critical. Expect to see continued leveraging of business-to-business (B2B) models and value-based care arrangements as new opportunities and approaches are also explored.


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Trending in Telehealth: July 18 – 24, 2023

by and | Jul 26, 2023 |

Trending in Telehealth is a new series from the McDermott digital health team in which we highlight 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:

  • Interstate compacts

A CLOSER LOOK

Finalized Legislation and Rulemaking

  • Connecticut enacted Substitute for SB 9, which enters the state into the Physical Therapy Licensure Compact.
  • Hawaii enacted SB 674, which enters the state into the Interstate Medical Licensure Compact.
  • Maine enacted LD 1749, which enters the state into the Physical Therapy Licensure Compact. Maine also enacted LD 717, which enters the state into the Audiology and Speech-Language Pathology Interstate Compact.
  • Rhode Island enacted HB 5737, which enters the state into the Nurse Licensure Compact.

Legislation and Rulemaking Activity in Proposal Phase

Highlights:

  • Alaska proposed a rule that would establish teletherapy standards of practice for psychologists and psychological associates, with the aim of providing clear guidelines for engaging in technology-assisted distance professional services.

Why it matters:

  • There continues to be elevated activity surrounding licensure compacts. This year has seen an uptick in legislative activity by states seeking to ease out-of-state licensure barriers through the use of interstate compacts. Certain compacts have a majority of states as members. As examples, Hawaii and Missouri became the Interstate Medical Licensure Compact’s 40th and 41st members, respectively, while Rhode Island became the Nurse Licensure Compact’s 41st member. As established compacts continue to grow their membership, a new compact has emerged: Missouri joined the Social Worker Licensure Compact earlier in July, becoming the first state to adopt the compact.

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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Key Takeaways | Regulatory Roadblocks and Opportunities: How to Thrive in a Shifting Healthcare Landscape

by | Jul 25, 2023 |

During this session, panelists offered insights into the regulatory action, rulemaking and legislation shaping the future of digital health, with a particular focus on artificial intelligence (AI), data privacy and the end of the COVID-19 public health emergency (PHE).

Session panelists:

  • Lucia Savage, Chief Privacy and Regulatory Officer, Omada Health, Inc.
  • Latoya S. Thomas, Head of Policy and Government Affairs, Included Health
  • Kate Tipping, Deputy Director, Regulatory and Policy Affairs Division Office of the National Coordinator for Health Information Technology (ONC)
  • Moderators:
    • Kristen O’Brien, Vice President, McDermott+Consulting
    • Rachel Stauffer, Senior Director, McDermott+Consulting

Top takeaways included:

  1. As the landscape changes, multiple regulatory entities continue to look closely at digital health, especially telemedicine and AI. Agencies are contemplating how to regulate effectively while focusing on the advancement of health equity and social determinants of health.
  2. ONC is proposing additional transparency requirements for AI in Certified Health IT through its recently proposed rule Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1). Through these new proposed transparency requirements, ONC is focused on promoting trust and increasing adoption by providers of AI tools embedded within Certified Health IT products. However, given that certain uses of AI in healthcare are already regulated by the US Food & Drug Administration, these new proposals may add additional regulatory layers to AI outside of current authorities.
  3. The end of PHE flexibilities is causing frustration and increased costs of compliance among digital-health providers. For example, the expiration of eased restrictions regarding the cross-border practice of medicine and other scope-of-practice limitations is requiring digital-health platforms to confirm that providers are appropriately licensed in applicable states and that care teams comprise providers practicing within the scope of their license.
  4. Industry stakeholders would like to see the US Centers for Medicare and Medicaid Services (CMS) take action on reimbursement for asynchronous telehealth services, primarily because the historical paradigm of reimbursing for synchronous telehealth services provided by a distant site to an originating site no longer reflects effective telehealth modalities in use today.


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Trending in Telehealth: July 11 – 17, 2023

by and | Jul 21, 2023 |

Trending in Telehealth is a new series from the McDermott digital health team in which we highlight 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 two weeks:

  • Medicaid coverage
  • Maternal health

A CLOSER LOOK

Finalized Legislation and Rulemaking

  • Alaska finalized regulations that implement 2022 legislation (HB 265) requiring the state Medicaid program to provide coverage for telehealth services. The regulations set out requirements related to coverage and payment through Medicaid for services provided via telehealth, including requirements for modalities and providers.
  • Maryland finalized regulations for the state Medicaid program that update the final date for which telehealth includes audio-only telephone conversations. The final date has been moved from June 30, 2023, to June 30, 2025, in line with legislation enacted in May 2023. The regulations also broaden eligibility for remote patient monitoring services by removing the requirement that the participant be at high risk for avoidable hospital utilization.
  • Maryland also finalized regulations for the state Medicaid program that update the requirements for urgent care centers, including requirements for supervision and services provided via telehealth.

Legislation and Rulemaking Activity in Proposal Phase

Highlights:

  • California passed AB 1478 in the first chamber. The bill would require the Department of Public Health to maintain a public database of referral networks for community-based mental health providers and support services addressing postpartum depression and prenatal care, including information on mental health providers and support groups that allow for patient-driven care access through telehealth and virtual care.
  • Colorado proposed a rule that would authorize the use of electronic consultation (eConsults) in the state Medicaid program. eConsults would take place through the authorized eConsult platform, which is currently in the process of being implemented by the Colorado Department of Health Care Policy and Financing. eConsults would involve an asynchronous interaction between a primary care provider and a specialty provider in order to obtain the specialty provider’s expert opinion. Specialty providers would be reimbursed only for eConsults that occur on the approved eConsult platform. More information regarding the eConsult Platform, currently scheduled to go live in winter 2024, is available here.
  • Texas proposed a rule that would extend the eHealth Advisory Committee (eHAC) for an additional two years. eHAC advises the Health and Human Services Commission Executive Commissioner and Health and Human Services agencies on strategic planning, policy, rules and services related to the use of health information technology, health information exchange systems, telemedicine, telehealth and home telemonitoring services, and is scheduled to sunset December 31, 2023.

Why it matters:

  • States continue to adopt rules addressing the use of telehealth in state Medicaid programs. Much of this regulatory activity is focusing on clarifying and expanding coverage for telehealth services in state Medicaid programs, [...]

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Key Takeaways | Putting Employee Wellness Programs to Work

by | Jul 18, 2023 |

During this session, panelists discussed the unique opportunities and challenges of digital-health wellness programs that partner with employers and health plans in considering, adopting and operationalizing wellness programs across their employee populations. The panelists discussed a wide range of challenges and opportunities, including accessibility to employees, navigating the health plan regulatory landscape, and being mindful of budgetary constraints and the reality of rising health carecosts.

Session panelists:

  • Denise Bloch, Vice President and Associate General Counsel, Regulatory and Compliance, SWORD Health
  • Tsion Lencho, Co-Chief Executive Officer, Cleo
  • Emily Taylor, Chief Financial Officer, Wondr Health
  • Sarah Raaii, Partner, McDermott Will & Emery
  • Moderator: Scott Weinstein, Partner, McDermott Will & Emery

Top takeaways included:

  1. Trends in employee health include looking for ways to drive healthcare costs down, which often involves adoption of employee wellness solutions, particularly digital-health wellness solutions.
  2. Employers are balancing the desire to find and adopt a “full-scale” solution that meets the unique needs of their workforce, while also considering budgetary constraints, the likelihood of employee utilization and the costs of implementing new benefits solutions.
  3. When implementing wellness programs, employers should be aware that they may be subject to the Employment Retirement Income Security Act (ERISA), the Health Insurance Portability and Accountability Act (HIPAA), or other laws and regulations governing health plans (e.g., the Consolidated Omnibus Budget Reconciliation Cat (COBRA)) if the program involves the provision of medical care to employees. Employers and/or health plans may request compliance assistance from their digital-health wellness programs, and digital-health companies should tread carefully to avoid liability for such compliance.


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Trending in Telehealth: June 27 – July 10, 2023

by and | Jul 12, 2023 |

Trending in Telehealth is a new series from the McDermott digital health team in which we highlight 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 two weeks:

  • Telehealth pilot programs, with a focus on home health
  • Licensure compacts

A CLOSER LOOK

Finalized Legislation and Rulemaking

  • Connecticut enacted SB 1705, which requires the Department of Public Health to establish a Hospice Hospital at Home pilot program to provide hospice care through a combination of in-person visits and telehealth.
  • Delaware adopted rules for home health agencies and personal assistance services agencies that define “telehealth mechanism” and address services provided via telehealth mechanisms.
  • Illinois enacted SB 1913, which requires the Department of Healthcare and Family Services and contracted managed care plans to provide for coverage of mental health and substance-use disorder treatment or services delivered as behavioral telehealth services, and reimburse such services on the same basis, in the same manner, and at the same reimbursement rate as in-person services are reimbursed.
  • Maine enacted LD 231, which establishes a statewide child psychiatry telehealth consultation service, to the extent funding allows. The service will support primary care physicians who are treating children and adolescent patients and need assistance with diagnosis, care coordination, medication management and any other behavioral health questions.
  • New Mexico finalized rules that define “telemedicine” for respiratory therapists.
  • Missouri enacted SB 70, which enters the state into the Counseling Interstate Compact, Interstate Medical Licensure Compact and Social Work Licensure Compact.
  • Oklahoma enacted HB 2686, which specifies telehealth encounters cannot be used to establish a valid physician-patient relationship for the purpose of prescribing opiates, synthetic opiates, semisynthetic opiates, benzodiazepine or carisoprodol, unless the encounter is used to prescribe opioid antagonists or partial antagonists under certain circumstances, or Schedule III-V controlled substances for medication-assisted treatment or detoxification treatment for substance-use disorder.

Legislation and Rulemaking Activity in Proposal Phase

Highlights:

  • Kentucky proposed a rule that would significantly update telehealth requirements for optometrists, including revising applicable definitions, informed consent requirements, practice standards and jurisdictional considerations (i.e., where a patient or physician may be located).
  • New Jersey passed S 3604 in the first chamber. The bill would incorporate the use of healthcare platforms (defined as “as an Internet-based service through which a consumer, who may or may not have separate health insurance coverage, may set-up an account or become a member to obtain discounts on prescription or non-prescription drugs or devices and through which other services, including telemedicine, may be provided”) into the laws governing pharmacy benefits managers, pharmacists and telehealth.
  • Ohio passed SB90 in the first chamber to enter the state into the Social Worker Licensure Compact.

Why it matters:



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Top Takeaways | Successfully Deploying Digital Health in Value-Based Care

by | Jul 11, 2023 |

In this session, McDermott Will & Emery Partner Lisa Mazur moderated a panel that explored how digital health tools can support financial and clinical success under value-based care arrangements. Panelists also looked at how digital health companies can successfully demonstrate value within the value-based care framework and make themselves attractive partners to value-based care companies. The panel showcased perspectives from executives at digital health companies and companies participating in value-based care models that have successfully leveraged digital health tools.

Session panelists included:

  • Jessica Beegle, Chief Innovation Officer, LifePoint
  • Jamie Colbert, MD, MBA, Senior Vice President of Care Delivery, Memora Healt
  • Ashul Govil, MD, MBA, Co-Founder and Chief Medical Officer, Story Health
  • Maulik Majmudar, MD, Chief Medical Officer and Co-Founder, Biofourmis
  • Kelsey P. Mellard, Founder and Chief Executive Officer, Sitka

Top takeaways included:

  1. Behind-the-scenes role. What do many successful digital health companies in the value-based care space have in common? They are operating behind the scenes, facilitating patient’s care with a trusted healthcare provider. The patient does not know they are interacting with a separate brand—rather, the companies position themselves as an extension of the local care team. This allows digital health companies to leverage the trust patients have with their physicians, increasing patient engagement as a result.
  2. Achieving provider buy-in. The panelists discussed several ways to achieve provider buy-in for digital health tools. A key theme was the ability of a digital health tool to integrate with providers’ existing systems and workflows. Clinicians do not want another portal to log into or another widget they are required to use. Rather, successful tools are those that are able to integrate into providers’ existing workflows and that improve those workflows as a result. Such integration requires a deep understanding of a provider’s operations and patient populations; the ability to leverage clinicians’ expertise; and engaging clinicians early during the design process and launch. The most successful digital health companies are those that are seen as a partner to providers, rather than simply being another vendor. Panelists also discussed how digital health companies need to be able to demonstrate value. While there are numerous ideas for digital health tools, successful tools will be those that deliver demonstrable outcomes.
  3. Successfully bridging the current fee-for-service world with value-based care. Successful digital health tools are those that can demonstrate value in both the fee-for-service (FFS) and value-based care models. Digital health companies must understand that for providers, the reality of the current system is organized around FFS. Successful companies are those that can meet providers where their systems are today, and work together towards value-based care. Panelists reflected that this requires a long view, flexible contracting models, and establishing progressive outcomes that can continue to be built upon.
  4. Value-based care: why now. The large penetration of Medicare Advantage (MA) is quickly changing the landscape. It provides digital health companies a large target audience that companies can meet, innovate around and innovate for, allowing companies to test their theses and adjust their models. Other accelerants [...]

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Key Takeaways | Women’s Health/Women+: Tapping into an Underserved Market

by | Jul 6, 2023 |

During this session, investors and business leaders discussed the future of women-focused care and the exciting opportunities in the rapidly growing sector of women/women+ health.

Session panelists:

  • Ashley Antler, Former Vice President, Legal and Head of Regulatory Affairs, SimpleHealth
  • Kim Boyd, M.D., Chief Medical Officer, Caire
  • Jessica Federer, Managing Partner, Supernode Ventures
  • Caroline Reignley, Partner, McDermott Will & Emery
  • Moderator: Stacey Callaghan, Partner, McDermott Will & Emery

Top takeaways included:

  1. Women’s health has historically been an under-resourced and underserved area of health. It wasn’t until 1993 that Congress required women and minorities to be included in clinical research funded by the National Institutes of Health (NIH). Centering men in clinical research and medical education has led to a real lack of understanding of how diseases affect women, and the healthcare system has not been built to account for the differences between men’s and women’s health.
  2. We are finally seeing research and data that is prompting developments and investments in women’s health. The 1993 NIH policy change kicked off the collection of data on women’s health—and 30 years later, that data is finally informing the development of new therapeutics and digital health solutions, as well as building awareness of the need for patient engagement, support and relevant platforms. Now that the therapeutics and digital solutions can be built, investments are needed to help women’s health companies and solutions come to market.
  3. Women’s health is much broader than fertility and menopause. For example, 80% of autoimmune patients and two-thirds of Alzheimer’s patients are women, and women have significantly worse outcomes than men in the year following a heart attack. Neurological health, cardiology, mental health, autoimmune conditions and gastroenterology are all areas ripe for women’s health solutions and investments.
  4. Women’s health can be both mission-driven and business-driven. As the business case for fertility solutions has exploded, there is hope that the business case will be seen for other areas of women’s health. The business case for women’s health is simple: women make the majority of healthcare buying decisions in the United States. With the explosion of fertility businesses, investors are starting to realize that women’s health is not just impact investing—there is, in fact, real money to be made in the women’s health space. There are opportunities in new therapeutics and digital solutions, including digital add-ons to existing platforms and brick-and-mortar operations. At the same time, companies and employers are realizing that investing in women’s health solutions is a smart business decision; when women lack access to the care they need, there is a tangible impact on workforce productivity.
  5. Given the constrained capital market, digital health companies in the women’s health space are facing challenges similar to those of other digital health companies, while also facing unique regulatory pressures and concerns. For example, there are real concerns that there will be an attack on access to contraception. These regulatory fears can chill investment in a tight market, having an impact on investors and innovators who are otherwise willing to enter [...]

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Trending in Telehealth: June 20 – 25, 2023

by and | Jun 30, 2023 |

Trending in Telehealth is a new series from the McDermott digital health team in which we highlight 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
  • Medical marijuana
  • Mental health
  • Reproductive health

A CLOSER LOOK

Finalized Legislation & Rulemaking

  • Florida enacted H 387, permitting qualified physicians to perform telehealth physical patient examinations before issuing subsequent physician certifications for the medical use of marijuana, as long as the patient examination for the initial certification was conducted in person.
  • Hawaii enacted HB 907, which conforms the state’s law regarding telehealth to the Medicare standards by clarifying that telehealth services provided by way of an interactive telecommunications system will be reimbursed by Medicaid.
  • Louisiana passed a final rule to adopt provisions in the Professional Services Program to continue to provide Medicaid reimbursement for physician-directed treatment-in-place ambulance services after the COVID-19 public health emergency ended on May 11, 2023. Reimbursement to the ambulance providers for initiation and facilitation of the physician-directed treatment-in-place telehealth service requires a corresponding treatment-in-place telehealth service. The corresponding treatment-in-place telehealth service is demonstrated via a Louisiana Medicaid paid treatment-in-place telehealth service claim.
  • New Hampshire enacted SB 264, which defines a mental health consultation during a surrogacy process to include a telehealth meeting.
  • New York enacted S 6749, creating a community-based paramedicine demonstration program that would permit emergency medical service personnel to provide community paramedicine and use alternative destinations, telemedicine to facilitate treatment.
  • New York enacted SB 1066, expanding protections for persons who perform legally protected reproductive health activity under state law to include protections for reproductive health services provided in person or by means of telehealth.
  • Ohio passed a final rule to amend the Ohio Vision Professionals Board rules to define telehealth-related terms and clarify the standard of care for telehealth services, patient consent requirements, doctor-patient relationship requirements and prescribing requirements.
  • Rhode Island enacted SB 565, which establishes telepractice standards for speech language pathologists and audiologists and adopts and incorporates the American Speech-Language-Hearing Association’s Code of Ethics.

Legislation & Rulemaking Activity in Proposal Phase

Highlights:

  • Maine progressed LD 231 in the second chamber to establish a statewide child psychiatry telehealth consultation service to support primary care physicians who are treating children and adolescent patients and need assistance with diagnosis, care coordination, medication management and any other necessary behavioral health questions.
  • Maine progressed LD 717 in the second chamber, establishing the Audiology and Speech-Language Pathology Interstate Compact.
  • West Virginia issued a proposed rule to establish procedures for the practice of telehealth by a licensed dietitian, including requirements for the patient-provider relationship.

Why it matters:

  • States continue to progress and pass legislation establishing telehealth processes for medical [...]

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Trending in Telehealth: June 13 – 21, 2023

by and | Jun 27, 2023 |

Trending in Telehealth is a new series from the McDermott digital health team in which we highlight 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:

  • Telehealth pilot programs
  • Mental health

A CLOSER LOOK

Finalized Legislation & Rulemaking

  • Connecticut enacted HB 6768, which permits physicians, advanced practice registered nurses and physician assistants to certify a qualifying patient’s use of medical marijuana and provide follow-up care using telehealth if they comply with other statutory certification and recordkeeping requirements.
  • Florida enacted HB 5101, which requires each school district to implement a school-based mental health assistance program that provides behavioral health services in-person and supplemented by telehealth.
  • Florida enacted SB 2500, which provides additional funding for telehealth services under the Minority Maternity Care program.
  • Illinois enacted SB 1298, amending the Home and Community-Based Services Waiver Program for Adults with Developmental Disabilities to permit medical and emergency telehealth services for persons with intellectual and developmental disabilities.
  • Louisiana enacted SB 186, adopting the Occupational Therapy Licensure Compact.
  • Louisiana enacted SB 66, which amends the state insurance code by replacing the term “telemedicine” with “telehealth,” for consistency throughout the code. The amendment does not require a provider to have an in-person examination with the patient prior to using telehealth but does require that a referral be made to an in-state healthcare provider or in-state follow-up care be arranged if necessary. The amendment also permits the use of interactive audio without video if, after access and review of the patient’s medical records, the healthcare provider determines that the provider is able to meet the same standard of care as if the services were provided in-person.
  • Louisiana enacted HB 41, which requires health plans to provide equivalent coverage and payments for telehealth occupational therapy services as for in-person services, unless the plan and the provider agree otherwise.
  • Louisiana enacted HB 181, which allows coroners to use telehealth when conducting an examination for an emergency mental health commitment.
  • Texas enacted HB 2727, which amends the requirements for the home telemonitoring program under Medicaid, including reimbursement requirements.
  • Texas enacted HB 617, which establishes a pilot project to provide emergency medical services instruction and emergency prehospital care instruction through a telemedicine medical service or telehealth service provided by regional trauma resource centers to healthcare providers in rural trauma facilities and emergency medical services providers in rural areas.
  • Texas enacted SB 1146, increasing access to telehealth services for inmates. The law requires the Department of Criminal Justice, in conjunction with The University of Texas Medical Branch at Galveston and the Texas Tech University Health Sciences Center, to establish procedures to expand access to telemedicine medical services, telehealth services and onsite medical care [...]

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