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Trending in Telehealth: October 29 – November 11, 2024

by Stacey Callaghan, Marshall E. Jackson, Jr. and Nathan Gray | Nov 19, 2024 | 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:

Interstate compacts
Behavioral health
Veterinary services
Disciplinary guidelines

A CLOSER LOOK

Proposed Legislation & Rulemaking:

In Washington, the Veterinary Board of Governors proposed amendments to board regulations to address the provision of veterinary services via telehealth. The proposed rule would permit licensed veterinarians to use telehealth to provide general health advice and emergency animal care advice, prescribe non-controlled substance sedation medication to facilitate transportation to an in-person visit, and, in certain circumstances, to dispense non-controlled substance medications prescribed by another veterinarian. Once a veterinarian-client-patient relationship had been established, the proposed rule would permit ongoing care to be provided via telemedicine.
In California, the Board of Behavioral Sciences proposed amendments to its telehealth rule to require licensed providers rendering services via telehealth to employ technologies, methods, and equipment that comply with all applicable federal and state privacy, confidentiality, and security laws, including HIPAA and the California Confidentiality of Medical Information Act.
South Carolina’s Department of Public Health released a proposal to permit licensed opioid treatment programs to perform the required initial screening examination via telehealth for patients admitted for treatment with buprenorphine or methadone. The proposed rule would require the use of audio-visual communications when evaluating patients for treatment using Schedule II medications but would permit use of audio-only platforms when treating patients with Schedule III medications.

Finalized Legislation & Rulemaking Activity:

The Florida Board of Clinical Social Work, Marriage and Family Therapy, and Mental Health Counseling finalized a set of guidelines that the board must follow when imposing disciplinary penalties upon telehealth registrants. The penalties include fines, reprimands, suspension with a corrective action plan, and revocation of the individual’s license.
In the District of Columbia, the mayor signed a bill (B 25-287) in which DC joins the Interstate Counseling Compact.

Why it matters:

Adoption of interstate licensure compacts continues to grow. Over the past year, there has been a notable trend of adoption of interstate licensure compacts for a wide range of providers. Even during slow periods for legislative and regulatory activity, DC’s adoption of the Interstate Counseling Compact reflects continued interest in these compacts.
States continue to adapt to the ongoing relevance of telehealth as a method of care delivery. The rule amendments proposed in Washington to permit the delivery of veterinary services via telehealth reflects ongoing recognition that telehealth can be used to provide a wide range of health services. The recently adopted disciplinary guidelines in Florida demonstrate how states have begun to adopt regulations specifically with telehealth in mind.

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 [...]

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Trending in Telehealth: October 21 – 28, 2024

by Renae Flowers, Lauren Ellison and Jayda Greco | Oct 31, 2024 | 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:

Professional standards
Marriage and family therapy services
Advance practice registered nurses (APRNs)

A CLOSER LOOK

Finalized Rulemaking:

The Arkansas Department of Health adopted a final rule setting forth requirements for the provision of marriage and family therapy services. The rule defines telemedicine and requires that a therapist-client relationship be established prior to the delivery of telemedicine services. Counselors and therapists also must document the treatment record, establish protocols for emergency services referrals, and provide the client with an electronic or hard copy of the treatment record documenting the encounter, if requested. While group therapy may be delivered via telemedicine, the rule precludes the use of group therapy for individuals 18 years of age or younger.
The Arkansas Board of Nursing adopted a final rule imposing requirements for APRNs providing care via telemedicine. Like the rule promulgated by the Department of Health, this rule requires APRNs to establish an APRN-patient relationship prior to the delivery of telemedicine services. An APRN rendering telemedicine services in Arkansas must be licensed to practice nursing in the state and cannot prescribe controlled substances unless the APRN has seen the patient for an in-person exam or a relationship exists through consultation or referral.

Why it matters:

States continue to implement rules to ensure that virtual care is delivered effectively, safely, and ethically. The Arkansas Department of Health and Board of Nursing enacted similar regulations, mandating that practitioners adhere to specific professional standards, including those related to scope of practice and licensure.
With the election less than one week away, legislative and regulatory activity remains slow. We anticipate an uptick in telehealth-related activity once the election concludes.

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.

Trending in Telehealth: October 14 – 21, 2024

by Amanda Enyeart, Lauren Ellison and Jayda Greco | Oct 25, 2024 | 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:

Medical practice standards
Maternal care
Opioid treatment

A CLOSER LOOK

Proposed Legislation & Rulemaking:

The Massachusetts Executive Office of Health and Human Services Division of Medical Assistance proposed a rule to establish requirements for the participation of programs of assertive community treatment (PACTs) in MassHealth. Each PACT provider may render services via telehealth, with justification for each instance of telehealth use documented and supported in the member’s record. The PACT provider also must be available to respond to member needs 24 hours per day, seven days a week, 365 days a year by phone, in person, or via telehealth whenever appropriate or safe. This includes ongoing or crisis services determined by member need.

Finalized Legislation & Rulemaking:

North Carolina adopted an emergency rule mandating that opioid treatment program (OTP) counseling staff be available, either in person or by telehealth, a minimum of five days per week. OTPs must establish and implement policies to determine the appropriateness of telehealth services that take into consideration the patient’s choice along with the patient’s behavior and physical and cognitive abilities. The patient’s verbal or written consent must also be documented when telehealth services are provided.

Why it matters:

States are proposing rules to ensure that healthcare providers are available around the clock to respond to patient needs through telehealth. Massachusetts’s PACT rule would require 24/7 provider availability, whether in person or via telehealth.
States continue to implement informed consent requirements for telehealth providers. North Carolina OTP providers must obtain written consent prior to rendering telehealth services.
As the election approaches, both legislative and regulatory activity remain slow.

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.

Trending in Telehealth: October 7 – 14, 2024

by Amanda Enyeart, Lauren Ellison and Jayda Greco | Oct 18, 2024 | 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:

Speech language pathology
Mental health and substance use disorder treatment

A CLOSER LOOK

Proposed Legislation & Rulemaking:

Illinois introduced to amend its insurance code to require coverage for speech therapy services that a treating provider deems medically appropriate as treatment for stuttering, regardless of whether the services are provided in person or via telehealth, as of January 1, 2026. Coverage would include the use of any communication technology, applications, or platforms that comply with the applicable privacy provisions of the federal Health Insurance Portability and Accountability Act of 1996.

The District of Columbia Department of Health Care Finance proposed a rule regarding the provision of medication therapy management services by pharmacists under the district’s Medicaid program, in accordance with the requirements of 29 DCMR § 910, which establishes the department’s standards for the provision of telemedicine services. The services, which are aimed at optimizing therapeutic outcomes for Medicaid beneficiaries, are limited to one initial visit and three follow-up visits per calendar year and may be provided in person or via telehealth.

Finalized Legislation & Rulemaking:

Alaska enacted HB 126, which authorizes associate counselors to provide certain services via telehealth. The legislation also extends certain immunity protections to providers who volunteer to provide services without pay through a medical clinic, medical facility, nonprofit facility, temporary emergency site, or other governmental facility, if acting within the scope of their responsibilities in such organization.
Pennsylvania’s upper house passed HB 2268, which, if signed by the governor, will mandate insurance coverage of rehabilitative speech therapy treatments for individuals with childhood stuttering and neurological stuttering.

Why it matters:

States are increasingly relying on telehealth to expand access to speech-language pathology services. Pennsylvania and Illinois took steps this week to expand access to such services, particularly for treatments involving stuttering therapy.
States continue to use telehealth as a means to address mental health and substance use disorders. Last week, Mississippi enacted a final rule to allow community service providers to perform substance use assessments either in person or via telehealth. Continuing this trend, this week Illinois expanded insurance coverage for behavioral health benefits with the goal of enhancing equity in mental health and substance use treatment. We expect to see a continued uptick in this activity going forward.

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.

360 Diligence for Digital Health Investments: What to Watch in Today’s Market Trends

by Marshall E. Jackson, Jr., Lisa Mazur, Dale C. Van Demark and Edward G. Zacharias | Oct 17, 2024 | Digital Health

Contributors: Dudley Baker, Managing Director, Holihan Lokey | Luiz Greca, Managing Director, Holihan Lokey | Chris Schickling, Managing Director, Gallagher

The digital health industry is complex and highly regulated, presenting unique challenges for investment in this space – especially for investors new to the healthcare industry. Healthcare companies have business lines and regulators that do not exist in other sectors of the economy, making it crucial to work with advisors that understand the value proposition of a healthcare business, where value resides amongst potential targets, and how valuations may vary. These complexities, coupled with current market trends, amplify the need for comprehensive diligence strategies to stratify risk and maximize value from advisors that understand the nuances of the healthcare sector.

In this article, we discuss the top three trends we’re seeing in digital health investment and how Gallagher, Houlihan Lokey, and McDermott Will & Emery can position your organization for success from pre-acquisition diligence to post-close operations.

Heightened Scrutiny on Healthcare Transactions and Physician Practice Management Structures

Healthcare transactions and physician practice management structures (sometimes referred to as the “friendly PC model”) are facing heightened scrutiny at both the state and federal levels. Regulators are imposing new requirements on parties and applying stricter transaction review standards, creating hurdles for healthcare investors and companies that may impact their ability to execute transactions and management relationships, and upend standard transaction timelines. For example, state laws like the recently passed and subsequently vetoed California’s AB 3129 seek to implement transaction notification and approval requirements that could present new obstacles to closing transactions and may extend pre-closing timelines. This bill would have also changed in the ways in which management companies and physician groups arrange for support services. Although Governor Newsom vetoed AB 3129, there is a newfound wave of support at both the state and federal levels to further regulate private investment in, and control of, healthcare organizations that continues to gain momentum. Oregon and Massachusetts are examples of other states that have considered similar legislation.

McDermott’s specialized focus on healthcare dealmaking and our scrutiny of the federal and state regulatory landscape helps investors and health companies stay ahead of legal developments, understand implications of proposed regulations, ensure compliance with federal and state agencies, and chart a course to move transactions through the review process efficiently.

Strengthening Cybersecurity

The healthcare sector is particularly vulnerable to cybersecurity issues and continues to be highly targeted for cybercrime. The health sector has historically under-invested in cybersecurity personnel and technology and is increasingly being targeted by sophisticated ransomware and other malicious threat actors.

In recent years, attacks on healthcare providers, insurers, and health technology vendors have resulted in catastrophic cyberattacks that have compromised patient data, resulted in a wave of class action litigation, and resulted in regulatory scrutiny and new regulations of the healthcare industry. These incidents are also incredibly expensive to contain, investigate, and remediate. In fact, according to the 2024 IBM-Ponemon Cost [...]

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Trending in Telehealth: September 30 – October 7, 2024

by Lisa Mazur, Lauren Ellison and Jayda Greco | Oct 17, 2024 | 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:

Professional standards
Teledentistry
Occupational therapy

A CLOSER LOOK

Proposed Rulemaking:

The Florida Nursing Board proposed a set of guidelines that the board must follow when imposing disciplinary penalties upon telehealth registrants. The penalties include reprimand, suspension with a corrective action plan, and revocation of the individual’s license.
New York proposed a rule to update its regulations for personal recovery-oriented services to align with telehealth guidance. The rule would mandate that individuals receiving intensive rehabilitation services be seen at least once in-person or through audio-visual telehealth during the calendar month.

Finalized Rulemaking:

Mississippi enacted a final rule that defines the Department of Mental Health’s certification requirements for community service providers. For all individuals reviewing mental health services and/or substance use services, the initial assessment and subsequent assessments may be provided either in-person or via telehealth.

Ohio adopted a final rule permitting occupational therapists to provide telehealth services. A provider may use synchronous or asynchronous technology during the initial patient visit. A provider also may deny a patient telehealth services and require the patient to undergo an in-person visit if care is continued with that provider.
Maine enacted a final rule permitting dentists to deliver diagnostic services via telehealth in accordance with the MaineCare Benefits Manual and current rules and guidance. The rule states that when delivering services via telehealth, dentists should bill for the underlying service and include the appropriate teledentistry CDT code that indicates a synchronous real-time encounter or an asynchronous encounter in which information is stored and forwarded to the dentist for subsequent review.

Why it matters:

States continue to expand access to telehealth services. Maine expanded access to teledentistry services, while Ohio expanded access to occupational therapy services and clarified the corresponding reimbursement methodology.
Legislation continues to slow as we approach the election, and many states have concluded the year’s legislative sessions. As mentioned in last week’s update, legislative activity has slowed, including legislation related to telehealth. Many legislators prefer to maintain the status quo until after elections, and legislative sessions in several states, such as California, have already concluded.

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.

Trending in Telehealth: September 17 – 30, 2024

by Patrick Zanayed, Lauren Ellison and Grayson Dimick | Oct 1, 2024 | 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:

Insurance and Medicaid reimbursement
Professional standards

A CLOSER LOOK

Proposed Legislation & Rulemaking:

The California governor vetoed AB 2339, which would have expanded the definition of “asynchronous store and forward” for Medicaid purposes to include asynchronous electronic transmission initiated directly by patients, including through mobile apps. The bill would have allowed Medicaid providers to establish a provider-patient relationship using asynchronous store and forward when the visit related to sensitive services.

The District of Columbia gave notice of a proposed Medicaid state plan amendment. The amendment would allow DC Medicaid to cover and reimburse for new remote patient monitoring (RPM) preventive services for eligible pregnant and postpartum individuals who are at risk of experiencing pregnancy-related morbidity or mortality issues. This amendment would include coverage for medically necessary monitoring devices, initial set-up and patient education on such devices, and collection and interpretation of the results by a healthcare professional.

The Texas Medical Board proposed repealing and replacing its telemedicine regulations. The proposed regulations are pared down from the current regulations, addressing only licensure and requirements for prescribing, and affirming that telemedicine medical services, including supervision, delegation, and posting of notices regarding filing a complaint, must be in compliance with Tex. Occ. Code C 111 and the Medical Practice Act.
At the federal level, the US House of Representatives approved the bipartisan HR 6033, which would create a task force focused on access to healthcare information technologies for non-English speakers. The bill would create best practices for:
- Facilitating and using interpreters during telemedicine visits.
- Providing accessible instructions for how to use telecommunication systems.
- Improving digital patient portals for non-English speakers.
- Integrating the use of video platforms that enable multi-person video calls via telecommunications.
- Providing patient materials, communications, and instructions in multiple languages. This would include text message appointment reminders and prescription information.

The bill defines “health information technology service providers” to include electronic medical record companies, RPM companies, and telehealth and mobile health vendors.

Finalized Legislation & Rulemaking:

Delaware enacted SB 301, which requires public universities to provide access to medication for the termination of pregnancy and emergency contraception. Although the medication and contraception must be provided onsite, the consultation to provide them may be performed through telehealth services.
Illinois enacted HB 4475, which amends the Insurance Code to address mental health and substance use parity requirements. The act provides that insured individuals have the right to select the provider or facility of their choice and modality, whether the care is provided via in-person visit or telehealth, for medically necessary mental health and substance use care.
The US Senate issued a joint resolution,
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Trending in Telehealth: August 26 – September 17, 2024

by Amanda Enyeart, Jessica Vishny and Grayson Dimick | Sep 20, 2024 | 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:

Out-of-state telehealth providers
Interstate compacts
Reimbursement requirements

A CLOSER LOOK

Proposed Legislation & Rulemaking:

California’s AB 2339 was approved by both chambers and sent to the governor for signature. The bill would expand the definition of “asynchronous store and forward” for the state’s Medicaid program, Medi-Cal, to include asynchronous electronic transmission initiated directly by patients, including through mobile apps. Existing law prohibits a healthcare provider from establishing a new patient relationship with a Medi-Cal beneficiary via asynchronous store and forward, audio-only, remote patient monitoring, or other virtual communication modalities, except as specified. Among those exceptions, existing law authorizes a healthcare provider to establish a new patient relationship using an audio-only synchronous interaction when the visit is related to sensitive services (e.g., mental or behavioral health, sexual and reproductive health, substance use disorder treatment, gender affirming care) and when established in accordance with Medicaid-specific requirements. AB 2339 would expand this exception to the use of asynchronous store and forward when the visit is related to sensitive services. Existing law also authorizes a healthcare provider to establish a new patient relationship using an audio-only synchronous interaction when the patient requests an audio-only modality or attests that they do not have access to video. AB 2339 would remove from that exception the option of the patient attesting that they do not have access to video, and would add a parallel exception to permit the use of an asynchronous store and forward modality when the client requests.
The North Dakota Board of Medicine proposed regulations that would provide exceptions to physician licensure for telehealth providers licensed in another state, including for continuation of care received outside of the state, temporary care while the patient is located within the state temporarily, preparation for a scheduled in-person visit, practitioner-to-practitioner consultations, and emergency circumstances.

Finalized Legislation & Rulemaking:

Delaware enacted SB 331 into law. Under the act, out-of-state practitioners who wish to prescribe controlled substances in Delaware, including those who have privilege based on a telehealth registration or compact license, must obtain a Delaware controlled substance registration.
Alaska enacted SB 75 into law, entering the state into the Audiology and Speech-Language Pathology Interstate Compact.
Alaska enacted SB 91 into law. The act updates the telehealth licensure exceptions (which currently allow physicians licensed in another state to provide telehealth services in Alaska without Alaska licensure under certain circumstances) to include exceptions for members of a physician’s multidisciplinary care team. “Multi-disciplinary care team” is defined to include nurses, advanced practice registered nurses, physician assistants, social workers, psychologists, licensed professional counselors, marriage and family therapists, physical therapists, occupational therapists, and other provider types. The exception applies when such services provided are not reasonably available [...]

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Updated Mandatory Disclosure Requirements for Colorado Mental Health Providers Go into Effect

by Lisa Mazur, Stacey Callaghan, Sam Siegfried and Angela Irene Theodoropoulos | Sep 11, 2024 | General Interest

On August 1, 2024, Colorado legislation took effect amending the mandatory disclosures that mental health providers must make to their clients under state law. Providers of mental health services in Colorado should take note of the new legislation and review their existing patient disclosure notices to ensure compliance.

Colorado law requires mental health providers to disclose certain information in writing during initial client contact. The statute covers a broad range of mental health providers, including psychologists, social workers, marriage and family therapists, licensed professional counselors, addiction counselors, and licensee candidates. Key elements of the mandatory disclosures include the following:

The provider’s name, business address, and business phone number.
The provider’s degrees; credentials; certifications; registrations; licenses; and related education, experience, and training.
Contact information related to the applicable board that regulates the provider’s profession.
Certain statements regarding fees, patient freedom of choice and rights to information, inappropriateness of sexual relationships between providers and clients, confidentiality of information discussed during sessions, and record retention requirements.

Colo. Rev. Stat. Ann. § 12-245-216(1).

The newly enacted legislation reduced the extent of the required mandatory disclosures. Previously, the Colorado statute required that providers include information explaining the levels of regulation applicable to different mental health professionals, but Senate Bill 24-115 removed this requirement. 2024 Colo. Legis. Serv. Ch. 217 (S.B. 24-115). This is a positive change for providers because it reduces some of the mandatory disclosures.

If you need assistance creating a patient notice to comply with the Colorado statute overall or assistance updating your existing disclosures, please reach out to us. We will work to address any questions you may have regarding the impact of this legislation and the compliance of your current forms.

Trending in Telehealth: August 13 – 26, 2024

by Amanda Enyeart and Angela Irene Theodoropoulos | Sep 4, 2024 | 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:

Licensing requirements
Substance use disorder
Teleoptometry

A CLOSER LOOK

Finalized Legislation & Rulemaking:

In Maine¸ the comment period deadline passed for a Department of Professional and Financial Regulation proposed rule, which, in part, implements the legislation to establish telehealth standards, uses, and limitations for the practice of optometry. The proposed rule would establish a comprehensive framework of virtual care delivery, imposing guidelines around scope of practice, underscoring the importance of identity verification, and providing a necessary reminder about the importance of informed consent for telehealth providers. If adopted, the rule would prohibit prescribing to a patient based solely on a static questionnaire and defines telehealth to exclude the provision of optometric services exclusively through an audio-only telephone, email, text messaging, instant messaging or US mail or other parcel service. While the proposed rule states that eye examinations should generally be performed in-person, it allows for a remote interview and examination “if the technology utilized in a telehealth encounter is sufficient to establish an informed diagnosis” as though care had been delivered in person.
In Nevada, the Board of Psychological Examiners adopted a final rule relating to the supervision of psychological assistants, psychological interns, and psychological trainees. The regulation imposes additional duties on the supervisor to ensure that “a psychological trainee receives at least 1 hour of individual supervision for each 10 hours of service delivery per week.” Notably, the regulation specifies that “service delivery” means “activities that involve direct contact with a client in-person or through telehealth.” Nevada currently defines “telehealth” as “the delivery of services from a provider of health care to a patient at a different location through the use of information and audio-visual communication technology, not including standard telephone, facsimile or electronic mail.”
The Oregon Criminal Justice Commission adopted a final rule to administer the state’s Jail-based Medications for Opioid Use Disorder Grant Program. The program will provide $10 million in funding to develop substance-abuse recovery programs to adults in custody. Under the rule, applicants for the grant must describe how the funds will be used to meet one of four requisite aims, including the provision of “medication, telemedicine, or any other reasonable treatment to persons in custody with an opioid disorder.”

Why it matters:

Regulators are adapting to the evolving healthcare delivery landscape. States continue to authorize telehealth care delivery for a wider range of practitioners. As evident from the proposed rule in Maine, however, such new authorizations can come with a myriad of compliance considerations, including obtaining informed consent, restrictions around prescribing, as well as heightened privacy and security concerns.
Regulators disavow a one-size-fits-all approach for virtual care delivery. As legislators and regulators become increasingly sophisticated as to the various telehealth modalities, they [...]

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