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Trending in Telehealth: October 11 – 16, 2023

by Stacey Callaghan and Ashley Ogedegbe | Oct 20, 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:

Reproductive Health
Telehealth Practice Standards
Disciplinary Guidelines
Behavioral Health
Regulatory Licensing

A CLOSER LOOK

Finalized Legislation and Rulemaking

In California, the governor signed the Nursing Facility Resident Informed Consent Protection Act of 2023. The new legislation amends the bill of rights for patients in skilled nursing facilities and establishes that healthcare professionals must disclose all material information regarding the administration of psychotherapeutic drugs to the patient to obtain the patient’s informed consent. Under the law, healthcare professionals may use remote technology, including telehealth, to obtain consent. The willful or repeated violation of these provisions will be punishable as a misdemeanor. However, the State Department of Public Health, in consultation with interested stakeholders, will not penalize facilities until December 31, 2025, when the Department plans to publish its standardized informed consent form.

Legislation and Rulemaking Activity in Proposal Phase

Highlights:

Connecticut’s Department of Consumer Protection proposed a rule to expand the prescribing authority of pharmacists. The rule would authorize licensed pharmacists who undergo the necessary training to prescribe emergency and hormonal contraceptives to patients. The rule would require pharmacists to assist patients with a Department-issued and interactive “screening document,” which includes questions to determine whether a hormonal or emergency contraceptive is clinically appropriate for a patient, age-appropriate health screening information, and a treatment algorithm for hormonal or emergency contraceptives. The screening document’s “treatment algorithm” is generated based on the clinical history entered by the patient, and it sets forth the steps of a treatment pathway and outlines when a referral to a practitioner is recommended. Licensed pharmacy technicians who undergo the necessary training can assist with the screening process, but ultimately the prescribing pharmacist must decide whether to issue the prescription or refer to a practitioner.
In Pennsylvania, HB 1300 passed the second chamber. If signed by the governor, the bill would allocate additional funds to the state’s Behavioral Health Commission for Adult Mental Health. It would also increase access to behavioral health via telemedicine services by providing funds for providers to purchase equipment such as computers, tablets, webcams, mobile devices, and telemedicine carts and kiosks; securing funds to assist with training and technical assistance for telemedicine services; providing grants to primary-care practitioners and organizations using telemedicine to deliver behavioral health integration services; and allocating additional funds for providers to purchase or maintain Healthcare Insurance Portability and Accountability Act (HIPAA)-compliant software, platforms, secure Wi-Fi hotspots and increased broadband speed and training beyond what is offered by the Department of Human Services.

Why it matters:

Continued Demand for Mental Health Initiatives. Pennsylvania’s proposed rule highlights ongoing demand for behavioral and mental health services. Increasing resources and funding for telemedicine services will give more patients convenient access to behavioral health [...]

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Trending in Telehealth: September 26, 2023 – October 10, 2023

by Purnima Boominathan and Ashley Ogedegbe | Oct 13, 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 two weeks:

Reproductive Health
Telehealth Practice Standards
Interstate Compact
Disciplinary Guidelines
Regulatory Licensing

A CLOSER LOOK
Finalized Legislation and Rulemaking

California signed into law SB 345, which goes into effect on January 1, 2024. The legislation states that California law applies to any civil, administrative or criminal proceeding involving individuals (that is, patients) located inside and outside of California engaged in providing, receiving, supporting, or attempting to provide or receive reproductive health and gender-affirming healthcare services via telehealth or other means. This “shield law” also provides legal protections for healthcare practitioners located in California who provide or dispense medication or other services for abortion, contraception or gender-affirming care to out-of-state patients. These protections apply regardless of the provider’s location during the activity. This law also prohibits California law enforcement, government officials or government contractors from cooperating with out-of-state prosecutions related to abortion, contraception or gender-affirming care. The law prohibits California-based corporations, including social media and tech companies, from disclosing to law enforcement any private patient communication regarding healthcare that is legally protected in the state.
New Hampshire enacted legislation effective October 7, 2023, that amends the prior law to permit out-of-state healthcare professionals to treat patients in the custody of the Department of Corrections via telemedicine, without a New Hampshire license, as long as the professionals are licensed in the state where they provide services. The prior law required all out-of-state healthcare professionals providing telehealth services to be licensed in New Hampshire, regardless of the patient’s location.

Legislation and Rulemaking Activity in Proposal Phase
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How Not to Lose $1 Million: Preparing for OIG’s Information Blocking Enforcement

by James A. Cannatti III and Alya Sulaiman | Oct 4, 2023 | Consumer Protection, Data Privacy, Data Transfers/Safe Harbor/Privacy Shield, Telehealth

OIG’s long-awaited final rule on investigating and imposing penalties for information blocking dropped in July 2023 and is effective as of Sept. 1, 2023 – almost three years after OIG released its proposed rule (April 2020) and two years after the start of information blocking compliance on April 5, 2021. The final rule codifies OIG’s authority to investigate information blocking complaints, including against developers of certified health IT and health information networks/health information exchanges (HIN/HIEs), and assess CMPs of up to $1 million per violation.

OIG defined a “violation” as a practice that constitutes information blocking as set forth in ONC’s information blocking regulations—a broad definition that is important because each distinct act or omission could be subject to a separate $1 million CMP. OIG also provided examples of what it would consider constituting a single violation versus multiple violations subject to multiple CMPs:

Single Violation: A certified health IT developer denies a single request by a healthcare provider to receive multiple patients’ EHI via an API and no legal requirement or information blocking exception applies. OIG would consider this a single violation even though it would result in preventing access to multiple patients’ EHI.
Multiple Violations: A certified health IT developer takes multiple separate actions to improperly deny multiple individual requests by a healthcare provider for EHI through an API. Each separate action would be considered a separate violation.

OIG has stated that while it does not intend to impose CMPs on conduct that occurred before Sept. 1, 2023, it may consider a regulated entity’s behavior from the April 2021 compliance date onwards in deciding if alleged information blocking conduct was part of a pattern of behavior. Other factors OIG anticipates considering when deciding penalty levels include the nature, circumstances, and extent of the information blocking and resulting harm, including the number of patients and/or providers affected and the number of days the information blocking persisted. OIG will also consider other factors, such as the degree of culpability, history of prior offenses, and other wrongful conduct.

When deciding whether to pursue a particular information blocking allegation, OIG indicated that it plans to prioritize enforcement for actions that:

Resulted in/had the potential to cause patient harm;
Significantly impacted providers’ ability to care for patients;
Are of long duration;
Caused financial loss to Medicare, Medicaid, or other federal healthcare programs or private entities; and
Were performed with actual knowledge.

Each allegation will require a facts and circumstances analysis, which OIG will conduct in coordination with ONC and other federal agencies as appropriate. Further, while OIG’s enforcement priorities may inform its decisions about which allegations to investigate, OIG states that the priorities are not dispositive, meaning it can investigate any allegations it chooses.

READ THE FULL ARTICLE ON THE HIMSS ELECTRONIC HEALTH RECORD ASSOCIATION BLOG HERE.

Weight-Loss Programs in Florida: State Law Considerations for GLP-1 Telehealth Providers

by Purnima Boominathan and Jayda Greco | Sep 29, 2023 | Telehealth

As more telehealth providers offer weight-loss programs, they should be aware of the potential impact of state laws and regulations. In this blog post, we take a closer look at Florida’s consumer protection laws regarding weight-loss programs.

OVERVIEW

While many providers are familiar with Florida’s Standards for the Prescription of Obesity Drugs (Fla. Admin. Code 64B8-9.012, see Final with ID: 26115424), providers may not be as familiar with the Florida Commercial Weight-Loss Practices Act. The Commercial Weight-Loss Practices Act, enacted in 2000 (Fla. Stat. 501.057 – Fla. Stat. 501.0581) broadly applies to weight-loss providers, which includes any person engaged in the business of offering services to consumers to assist them in losing weight and making oral or written statements, visual descriptions, advertisements or other representations that have the capacity, tendency or effect of leading consumers to believe that participation in a weight-loss program will result in weight loss. See Fla. Stat. 501.0571(5). Additionally, weight-loss providers are required to:

Provide to a consumer a written, itemized statement of the fixed or estimated cost of the weight-loss program that is being recommended, including all additional products, services, supplements, examinations or laboratory tests the consumer may be required to purchase from the weight-loss provider as part of such program
Disclose the actual or estimated duration of the recommended weight-loss program
Provide, upon request, a copy of the educational and professional experience of the weight-loss provider’s staff
Provide the name, address and qualifications of the person who has reviewed and approved the weight-loss program, according to section 468.505(1)(j)
Produce and distribute to all consumers who inquire about their weight-loss program a palm-sized card with the Weight-Loss Consumer Bill of Rights printed on it
Post conspicuously the Weight-Loss Consumer Bill of Rights at the front registration desk in each weight-loss program location and require every agent, representative, franchisee or independent contractor to post such a bill of rights in a prominent place in every room in which a presentation or sale of a weight-loss program is made or in which a product or treatment is offered for sale

See Fla. Stat. 501.0573.

Notably, the Weight-Loss Consumer Bill of Rights is a required, separate consumer-facing document that requires disclosure that “rapid weight loss may cause serious health problems,” among other safety disclosures and protections intended for disclosure before beginning a weight-loss program.

KEY TAKEAWAYS

Florida’s Commercial Weight-Loss Practices Act is a reminder that telehealth providers should look beyond the telehealth and prescribing regulations in each state. For telehealth providers operating in a number of states, an in-depth review of all of the relevant state laws and regulations is critical to capture the framework of applicable laws and regulations across the spectrum of health and consumer protection. For providers without in-person practice locations, there are often other strategies that meet the relevant requirements and can ensure compliance with these laws.

Telehealth is an important development in care delivery, but the [...]

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Trending in Telehealth: September 19 – 25, 2023

by Patrick Zanayed and Jayda Greco | Sep 28, 2023 | Telehealth

Trending in the past week:

Interstate Compacts
Medicaid Coverage
Telehealth Practice Standards
Telehealth Access

A CLOSER LOOK

Finalized Legislation and Rulemaking

New Hampshire enacted HB 409, which enacts the Social Worker Licensure Compact.
Louisiana adopted rulemaking regarding Medicaid coverage for physician-directed treatment-in-place ambulatory services. The rule allows such services to be provided via telehealth when the provider meets certain requirements, such as enrollment and notification to the Department of Health.
Alaska adopted rulemaking that provides eligibility requirements and defines the scope of services for delivering psychological care through electronic means while physically separate from the recipient. The regulations require applicants for a courtesy license to be licensed in another jurisdiction where the licensing requirements are at least equivalent to those in Alaska.

Legislation and Rulemaking Activity in Proposal Phase

Highlights:

As mentioned in last week’s update, California progressed two bills that are now awaiting the governor’s signature.
- AB 1478 was presented to the governor on September 20, 2023. The bill would require the State Department of Public Health to maintain, on its website, a database of referral networks for community-based mental health providers and support services addressing postpartum depression and prenatal care, and information on mental health providers and support groups that allow patient-driven care access, including telehealth and virtual care.
- AB 48 also was presented to the governor on September 20. The bill would require the State Department of Public Health, in consultation with interested stakeholders, to develop a standardized informed consent form which would then need to be available to skilled nursing facilities and intermediate facilities by December 31, 2025. Additionally, the bill would permit prescribers to use remote technology, including telehealth, to examine patients and obtain the above mentioned informed written consent.
Ohio proposed rulemaking specifying the requirements for delivery of services by speech-language pathologists and audiologists via telehealth, such as licensure and encryption requirements and guidelines for assessing whether telehealth is appropriate based on the patient’s condition.

Why it matters:

Increased activity in California continues. California continues to move forward with legislation to address access to healthcare services via telehealth. While they increase access, these bills are addressed to specific sites of care, such as nursing facilities, reflecting an openness to telehealth under specific circumstances.
States are focused on Medicaid reimbursement for telehealth services. This week, we saw Louisiana adopt rulemaking regarding Medicaid coverage for physician-directed treatment-in-place ambulatory services.
Telehealth practice standards remain a focus. Alaska and Ohio’s enacted and proposed rulemaking, respectively, continue the trend of states expanding on telehealth practice standards for non-physician licensees.

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

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Trending in Telehealth: September 5 – 18, 2023

by Amanda Enyeart and Jayda Greco | Sep 22, 2023 | Telehealth

Trending in the past week:

Medicaid Coverage
Broadband Access
Behavioral Health and Substance Use Disorder Treatment
Practice Standards Across Licensee Types

A CLOSER LOOK

Finalized Legislation and Rulemaking

California enacted AB 1241, which was presented for signature last week. As noted in our prior updates, the bill will loosen certain requirements related to the virtual delivery of care within the Medi-Cal program.
Maryland made effective a host of non-substantive rulemaking updates related to professional standards for telehealth across a variety of licensee types, including optometrists, massage therapists, social workers, dietitians, chiropractors, audiologists, speech language pathologists, hearing aid dispensers, music therapists, physical therapists, occupational therapists and professional counselors. The final rules provide clarity by removing language regarding the physical location of a practitioner or patient when providing telehealth and by removing ambiguous and other language to be consistent with telehealth regulations adopted by other health occupations boards.

Legislation and Rulemaking Activity in Proposal Phase

Highlights:

California progressed several bills to the engrossing and enrolling stage and to the governor for signature.
- AB 965 moved from the second committee to the governor for signature. The bill is an amendment to the Permit Streamlining Act that would require local agencies that process applications for the construction of broadband projects to simultaneously process multiple broadband permit applications for substantially similar projects under a single permit (so-called batch broadband permit processing), with the goal of ensuring a more efficient broadband approval process.
- AB 1369 also progressed from the second committee to the governor for signature. This legislation provides that a person licensed as a physician and surgeon in another state would be authorized to deliver healthcare via telehealth to a patient who, among other requirements, has a disease or condition in which there is a reasonable likelihood of death within a matter of months.
- AB 1478 was enrolled on September 14, 2023. The bill would require the State Department of Public Health to maintain, on its website, a database of referral networks of community-based mental health providers and support services addressing postpartum depression and prenatal care, information on mental health providers and support groups that allow patient-driven care access, including telehealth and virtual care.
- AB 912 was enrolled on September 16, 2023. The bill would authorize school-based health centers to provide primary medical care, behavioral health services or dental care services on site or through mobile health or telehealth.
- AB 48 was sent to engrossing and enrolling on September 13, 2023. The bill would add nursing [...]
  
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Key Takeaways | What the Money Thinks: Investing in Innovative Care Delivery

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

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

Session panelists:

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

Top takeaways included:

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

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

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

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

Session panelists:

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

Top takeaways included:

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

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Trending in Telehealth: August 29 – September 5, 2023

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

Trending in the past week:

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

A CLOSER LOOK

Finalized Legislation and Rulemaking

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

Legislation and Rulemaking Activity in Proposal Phase

Highlights:

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

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

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

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

Session panelists:

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

Top takeaways included:

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

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