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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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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Top Takeaways | 2023 PPM-ASC Symposium | Leveraging Data Collaborations for Revenue Growth

by | Jun 27, 2023 |

In this session, the panelists discussed the successes and challenges of a data collaboration between Gastro Health and Lynx.MD, and provided real-world insights into how a physician platform can harness its data to enhance patient care and generate additional revenue while maintaining compliance with applicable privacy and security regulations.

Session panelists included:

  • Omer Dror, Founder and Chief Executive Officer, Lynx.MD
  • Rich Weissmark, Senior Vice President of Strategic Operations, Gastro Health
  • Moderator: Stephen Bernstein, Partner, McDermott Will & Emery

Top takeaways included:

  • Organizing and understanding patient data can require a large up-front investment, as it can be costly, time-consuming and challenging. This is often the largest hurdle in data collaborations; but once that step is addressed, the ability to harness the data for patient care and research can be exponentially valuable over time.
  • Data has a multitude of uses, e.g., internally within a practice to improve patient care and externally with life sciences partners and other stakeholders to analyze trends and forge innovation (provided that data shared externally is properly deidentified, or takes the form of a limited data set that is subject to proper data-use agreements). A physician practice with curated data that can be meaningfully used will be far better positioned to discuss and negotiate value-based care and alternative payment models with various payors.
  • While some data modeling focuses on just one use, the best opportunities may come from innovations that consider all of the other potential uses for the data. The specific disease states that are of interest to clinicians delivering care are often the same as those that interest life sciences companies. As a result, this is an opportunity for cost savings: collecting the data once, transforming it into separate deidentified data cuts and then using it for different purposes, which can include potential revenue-sharing opportunities relative to deidentified data sets.
  • Practices that want to develop data sets and forge data collaborations should act with intention in negotiating contracts that involve data and anticipate what data they may need in the future. If practices give away data rights too soon, it may be difficult to ensure future flexibility and opportunities for that data in the future. Contracts could be with electronic medical records (EMR) companies, pharmaceutical companies and various vendors, so practices should review these contracts closely and try to keep options open for future opportunities.
  • Healthcare data is inherently sensitive and heavily regulated. In addition to putting strong data-governance policies in place that support Health Insurance Portability and Accountability Act (HIPAA) regulations, companies looking to build a data strategy should make sure to consult with legal counsel in developing a plan to use the data. Data privacy and security, deidentification, the creation of limited data sets, data rights, and the level of trust between a physician platform and its data-sharing partners should all be considered before attempting to form a data collaboration.
  • Innovative use of technology and associated data use can be a differentiating factor in recruiting younger physicians who are excited about [...]

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Key Takeaways | Global Perspectives on Data Sharing and Privacy

by | Jun 20, 2023 |

During this session, the panel discussed strategies and business considerations when addressing compliance with the wide array of data protection and privacy laws and regulations across the United States and abroad. The panel shared insights on compliance and monitoring strategies as well as best practices in working with internal stakeholders.

Session panelists:

  • Rebecca Daley, Esq., Senior Associate Counsel, Office of the General Counsel, University of Maryland Medical System
  • David Linestky, Senior Vice President, Life Sciences, Phreesia
  • Roshal Marshall, Managing Chief Counsel, Enterprise Data Privacy, Security and Technology Law, McKesson Corporation
  • Erik Phelps, Executive Vice President, Chief Administrative and Legal Officer, Tempus Labs, Inc.
  • Sharon Lamb, Partner, McDermott Will & Emery
  • Moderator: Amy Pimentel, Partner, McDermott Will & Emery

Top takeaways included:

  • Saying that the privacy landscape is “dynamic” is an understatement. The rapidly evolving landscape is challenging to operationalize, as many companies find that their lines of business operate under different (and often overlapping) areas of the regulatory framework.
  • As digital health solutions continue to be embedded in traditional health offerings, one challenge that lies ahead is the ability to “future proof” compliance strategies. It will be critical to remain flexible as future collaborations present opportunities for industry growth and development.
  • It is crucial for business leaders to understand their organization’s data collection, storage and sharing processes and how they want to leverage data as an asset. This knowledge is particularly important when designing data strategies, designing notices and consents, and leveraging contractual protections in current and future partnerships.


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