COVID-19 Archives - OF DIGITAL INTEREST

COVID-19

2024: The Year of the Telehealth Cliff

by Lisa Mazur, Rachel Stauffer, Debra Curtis and Leigh Feldman | Jan 12, 2024 | Telehealth

What does December 31, 2024, mean to you? New Year’s Eve? Post-2024 election? Too far away to know?

Our answer: December 31, 2024, is when we will go over a “telehealth cliff” if Congress fails to act before that date, directly impacting care and access for Medicare beneficiaries. What is this telehealth cliff? Let’s back up a bit.

TELEHEALTH COVERAGE POLICIES

Current statute (1834(m) of the Social Security Act) lays out payment and coverage policies for Medicare telehealth services. As written, the provisions significantly limit Medicare providers’—and therefore patients’—ability to utilize telehealth services. Some examples:

If the patient is in their home when the telehealth service is being provided, telehealth is generally not eligible for reimbursement.
Providers cannot bill for telehealth services provided via audio-only communication.
There is a narrow list of providers who are eligible to seek reimbursement for telehealth services.

COVID-19-RELATED TELEHEALTH FLEXIBILITIES

When the COVID-19 pandemic hit in 2020, a public health emergency (PHE) was declared. Congress passed several laws, and the administration acted through its own authorities to provide flexibilities around these Medicare telehealth restrictions. In general, nearly all statutory limitations on telehealth were lifted during the PHE. As we all know, utilization of telehealth skyrocketed.

The PHE ended last year, and through subsequent congressional efforts and regulatory actions by the Centers for Medicare and Medicaid Services (CMS), many flexibilities were extended beyond the end of the PHE, through December 31, 2024. Congress and CMS continue to grapple with how to support the provision of Medicare telehealth services for the future.

CMS has taken steps through the annual payment rule, the Medicare Physician Fee Schedule (MPFS), to align many of the payment and coverage policies for which it has regulatory authority with congressional deadlines. CMS has also restructured its telehealth list, giving more clarity to stakeholders and Congress as to which pandemic-era telehealth services could continue if an extension is passed. But CMS can’t address the statutory limitations on its own. Congress must legislate. CMS highlighted this in the final calendar year (CY) 2024 MPFS rule released on November 2, 2023, noting that “while the CAA, 2023, does extend certain COVID-19 PHE flexibilities, including allowing the beneficiary’s home to serve as an originating site, such flexibilities are only extended through the end of CY 2024.”

THE TELEHEALTH CLIFF

This brings us to the telehealth cliff. CMS generally releases the annual MPFS proposed rule in July, with the final rule coming on or around November 1. If history is any indication, Congress is not likely to act on the extensions much before the current December 31 deadline. This sets up the potential for a high level of uncertainty headed into 2025.

If we go over, this telehealth cliff would directly impact care and access for Medicare beneficiaries. The effects could be felt acutely in rural and underserved areas, where patients have been able to access, via telehealth, medical services that may have been out of reach for them in the past. The telehealth cliff would [...]

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Teleprescribing of Controlled Substances Temporarily Extended Beyond PHE – What’s Next?

by McDermott Will & Emery | May 10, 2023 | Telehealth

The US Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) are extending telehealth flexibilities that allow providers to prescribe controlled substances. While the extension is in place, the DEA indicated that, in light of the 38,000 comments it has received, it will be further evaluating its recently proposed rules for post-PHE telemedicine prescription of controlled substances. Learn what stakeholders need to monitor during this time and what may be next from the DEA.

Read the On the Subject here.

Trending in Telehealth: April 25 – May 1, 2023

by Patrick Zanayed and Jayda Greco | May 3, 2023 | Telehealth

Trending in Telehealth is a series from the McDermott digital health team in which we highlight state legislative and regulatory developments that impact healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate virtual care.

Trending in the past week:

Interstate Compacts
Professional Practice Standards
COVID-19 Licensure Flexibilities

A CLOSER LOOK

Finalized Legislation & Rulemaking

Illinois enacted HB 559, which allows any person who was issued a temporary out-of-state permit by the Illinois Department of Financial and Professional Regulation during the COVID-19 pandemic to continue to practice under her temporary out-of-state permit if she submits an application for licensure by endorsement to the Department on or before May 11, 2023. The legislation allows any such person to continue to practice under his temporary out-of-state permit until the Department issues the license or denies the application, at which time the temporary out-of-state permit will expire. The legislation also updates the definition of “direct supervision” for a speech language pathologist assistant to include video conferencing.
Tennessee enacted HB 498 and companion bill SB 721. The legislation exempts a patient receiving an initial behavioral health evaluation via telehealth from the reimbursement requirement that the patient have an in-person encounter with a healthcare services provider, the provider’s practice group or the healthcare system within 16 months prior to an interactive visit in order to establish a provider-patient relationship for purposes of telehealth.
North Dakota, Montana and Oklahoma enacted legislation (SB 2187, HB 777 and SB 575, respectively) to join the Counseling Compact.

Legislation & Rulemaking Activity in Proposal Phase

Highlights:

Montana progressed legislation to join the Occupational Therapy Compact (SB 155). Meanwhile, Iowa and Indiana progressed legislation to the second chamber (HF 671 and SB 160, respectively) to enact the Counseling Compact. South Carolina introduced legislation (S 610) that would enact the Counseling Compact, and Louisiana introduced legislation (SB 186) to join the Occupational Therapy Compact.
New Hampshire progressed legislation (HB 500) that would modify which controlled substances are permitted to be prescribed via telemedicine. The legislation would allow an advanced practice registered nurse (APRN) to prescribe non-opioid and opioid controlled drugs in schedule II through IV by means of telemedicine after establishing a relationship with the patient. When prescribing a non-opioid or opioid controlled drug classified in schedule II through IV via telemedicine, a practitioner licensed to prescribe the drug must conduct subsequent in-person exams at intervals appropriate for the patient, medical condition and drug, but not less than annually. The legislation further provides that an APRN who prescribes these drugs by telemedicine must obtain oral or written consent for the provision of services through telemedicine from the patient or, if the patient is a minor, from the patient’s parent or guardian unless state or [...]

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Trending in Telehealth: April 4 – 10, 2023

by Dale C. Van Demark and Jayda Greco | Apr 13, 2023 | Telehealth

Trending in Telehealth is a new series from the McDermott digital health team in which we highlight state legislative and regulatory developments that impact healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate virtual care.

Trending in the past week:

Interstate Compacts
COVID-19 Extensions for Licensing
Behavioral Health

A CLOSER LOOK

Finalized Legislation & Rulemaking

In Tennessee, HB 729 was signed into law. Under the legislation, a physician available via telephone or telehealth meets the general supervision requirements for a speech language pathologist performing an endoscope. The law becomes effective on July 1, 2023.
In Kentucky, HB 311 was enacted. The legislation prohibits the Department for Medicaid Services and any Medicaid managed care organization from requiring that a health professional or medical group maintain a physical location or address in the state to be eligible for enrollment as a Medicaid provider if the provider or group exclusively offers services via telehealth.
In New Mexico, HB 384 requires the licensing board to issue a telemedicine license to applicants who hold a full and unrestricted license to practice medicine in another state or territory of the United States. The board will establish by rule the requirements for licensure, provided that the requirements are not more restrictive than those required for expedited licensure.

Legislation & Rulemaking Activity in Proposal Phase

Highlights:

In Kansas (HB 2288), Missouri (SB 70), Montana (HB 777) and North Dakota (SB 2187), legislation to establish the Counseling Compact progressed. In Montana (SB 155) and Indiana (SB 73), legislation to enact the Occupational Therapy Compact progressed.
Florida introduced legislation (SB 300) that would prohibit physicians from using telehealth to provide abortions or prescribe abortion-inducing medication. It would also require the physical in-person presence of a physician with a patient when an abortion is performed or when abortion-inducing medication is dispensed.
Maryland progressed legislation (SB 582) that would extend until June 30, 2025, the inclusion of certain audio-only telephone conversations in the definition of “telehealth” in the Maryland Medical Assistance Program, as well as requirements related to reimbursement for telehealth services by the program and certain insurers, nonprofit health service plans and health maintenance organizations.
Georgia proposed legislation (SB 20) that would prohibit insurers from the following:
- Requiring prior authorization, medical review or administrative clearance for a telehealth service that would not be required if such service were provided in person
- Requiring demonstration that it is necessary to provide a service to a covered person through telehealth
- Requiring a provider to be employed by another provider or agency in order to provide a telehealth service when such employment would not be required if the service were provided in person
- Denying coverage solely based on the communication technology or application used
- Requiring a [...]
  
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Trending in Telehealth : March 28 – April 3, 2023

by Stacey Callaghan and Jayda Greco | Apr 6, 2023 | Telehealth

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 of virtual care.

Trending in the past week:

Interstate Compacts
COVID-19 Extensions for Licensing
Behavioral Health

A CLOSER LOOK

Finalized Legislation & Rulemaking

In Vermont, H 411 was signed into law. As noted in last week’s report, the bill extends Vermont’s telehealth registration for out-of-state healthcare professionals until a permanent telehealth licensure and registration system is operational. The registration, which was previously set to expire on June 30, 2023, provides a telehealth registration for out-of-state healthcare professionals who file an application and meet certain requirements to provide telehealth services in Vermont, which is more expeditious than the state’s licensure process. The registration is extended until March 31, 2024. The bill also extends certain enforcement discretion provisions. For example, the bill clarifies that the state will not penalize providers for using telehealth services that do not comply with the requirements of the Health Insurance Portability and Accountability Act of 1996. The bill states that the extension of these provisions is subject to federal law or guidance regarding enforcement discretion. Notably, federal HIPAA enforcement discretion is set to end on May 11, 2023, at the end of the federal public health emergency.
In Idaho, H 61 was signed into law and becomes effective on July 1, 2023. The bill allows a mental or behavioral health provider who is not licensed in Idaho to provide services via telehealth to an Idaho resident or person located in Idaho. The provider must meet certain qualifications, such as holding a current, valid and unrestricted license in another state with substantially similar requirements to Idaho and not being subject to any past or pending disciplinary proceedings. The provider must also biennially register in Idaho to provide telehealth services.
In Washington, SB 5036 was signed into law. As noted in last week’s report, the bill extends the timeframe in which real-time, audio-visual telemedicine services can be used to establish a provider-patient relationship for the purpose of providing audio-only telemedicine for certain healthcare services. Under the bill, a provider can use simultaneous audio and video technology to establish a provider-patient relationship through July 1, 2024, as opposed to the previous deadline of January 1, 2024. The bill suggests that after the 2024 deadline, a provider will need to see a patient in person within a certain time period to establish a provider-patient relationship.

Legislation & Rulemaking Activity in Proposal Phase

Highlights:

In Kansas (HB 2288), Oklahoma (SB 575) and North Dakota (SB 2187), legislation progressed to establish the Counseling Compact. In Indiana (SB 73) and Washington (HB 1001), legislation progressed to enact the Occupational Therapy Compact and the [...]

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Preparing for the End of the COVID-19 Emergency: Tri-Agencies Issue FAQs to Assist Plans and Issuers

by McDermott Will & Emery | Apr 3, 2023 | Telehealth

The Biden administration has announced its intent to end the COVID-19 National Emergency (NE) and the COVID-19 Public Health Emergency (PHE) on May 11, 2023 (read our prior article for more information). In response to the COVID-19 pandemic, lawmakers and agencies made legislative and regulatory changes to expand access to telehealth services for individuals. This article explores what will happen to these temporary telehealth benefits at the end of the PHE and NE.

Read the full report.

Staying Connected: An Update on Medicare Reimbursement for Telehealth Services After the PHE

by Amanda Enyeart, Dawn R. Helak, Marshall E. Jackson, Jr., Lisa Mazur, Dale C. Van Demark, Mara McDermott and Lauren Knizner | Dec 21, 2021 | Telehealth

In hopes that the COVID-19 public health emergency (PHE) will soon end, Congress and the administration are evaluating the telehealth expansions and flexibilities put in place to respond to the PHE. As a result, the future for telehealth stakeholders remains uncertain. This article outlines various changes in Medicare telehealth reimbursement policy in effect during the PHE and identifies what actions would be required to make these changes permanent.

Since the implementation of the PHE, there has been a significant uptick in the provision of telehealth services by Medicare, other public payers and commercial payers. In response to this increased utilization and outreach by stakeholders, Congress has actively explored ways to make some, or all, of the PHE flexibilities permanent.

During the PHE, telehealth providers have been able to receive reimbursement for a greater variety of telehealth services, leverage more types of healthcare providers, and treat patients in more locations than ever before. Telehealth providers have been energized by these changes and are voicing resistance to the prospect of losing these new reimbursement opportunities post-PHE.

The pathways to making telehealth flexibilities permanent, however, are neither simple nor clear. Reimbursement for telehealth services is governed by complex statutory, regulatory and subregulatory requirements at the state and federal level. At the federal level, the PHE-driven changes have come via both federal legislation and regulatory modifications. This article describes what steps would be necessary to make federal telehealth reimbursement policy changes permanent as the healthcare system recovers and rebuilds from the COVID-19 pandemic.

CLICK HERE TO ACCESS THE FULL REPORT.

CMS Addresses Virtual Care Expansion in CY 2022 Medicare Physician Fee Schedule Proposal

by Amanda Enyeart, Marshall E. Jackson, Jr., Lisa Mazur and Dale C. Van Demark | Jul 27, 2021 | Telehealth

On July 23, 2021, the Centers for Medicare & Medicaid Services (CMS) published its annual proposed changes to the Medicare Physician Fee Schedule (MPFS), which include several key telehealth and other virtual care-related proposals. The proposals address long-standing restrictions that have historically limited the use of telehealth and virtual care, including geographic and originating site restrictions, and limitations on audio-only care, as well as coverage extensions for some services added during the COVID-19 public health emergency.

These proposals include:

The implementation of the Consolidated Appropriations Act, 2021 (CAA) in-person visit requirement for mental health services that either do not meet Medicare’s typical geographic restrictions or occur when the originating site is the patient’s home, regardless of geography
The ability for certain mental health services to be delivered via audio-only communications when patients are located in their homes (however, in these cases, the provider would also be required to comply with the in-person visit requirement described above)
The extension of coverage of the services temporarily added to the Medicare telehealth services list (Category 3 services) through the end of CY 2023 to allow more time for evaluation, and the rejection of proposed new, permanent Medicare telehealth services
The permanent adoption of HCPCS Code G2252 for extended virtual check-ins, which was established on an interim basis in the CY 2021 MPFS.

Read the full article here.

Three Digital Health Trends Affecting Investors in 2021

by Lisa Mazur | Feb 23, 2021 | Telehealth

Private equity deal volume hit a low in the first half of 2020 as the pandemic slowed the US and global economies. But toward the end of the year, deals began picking back up, particularly in the digital health space.

COVID-19 forced healthcare providers to shift from in-person to virtual care, and technology was the vehicle to make that switch possible. Investors noticed, and more deals focused on companies specializing in telehealth, remote patient monitoring and other technology platforms that facilitate communication among specialists.

Expect this trend to continue in 2021, and keep these three factors in mind when evaluating the digital health landscape.

Easing of Laws and Regulations Surrounding Telehealth and Digital Health

Both telehealth and digital health are highly regulated, as every state has laws and regulations that govern how care is provided virtually and how those services are billed. In response to the pandemic, we’ve seen flexibility with these laws and regulations, and the Biden administration has signaled that it might make some flexibilities permanent.

Investment opportunities will likely increase as a result of the Biden administration’s willingness to lower some of the longstanding barriers to coverage and payment for virtual services, including telehealth, remote patient monitoring and other related services. That’s a positive sign for firms looking at healthcare through the lens of a technology solution.

Reallocation of Resources Due to Vaccine Rollout

Since the onset of the pandemic, labs have conducted a huge volume of testing and have had to ramp up personnel and other resources. Plus, the vast majority of COVID-19 tests must be ordered by a physician or nurse, further straining available resources.

While testing will likely continue in some capacity for a long time, the number of tests will presumably decline steadily as more people are vaccinated. That means capacity will open up, both for healthcare providers who were ordering the tests and for lab companies that were performing them. As a result, firms should begin asking themselves:

Where are there opportunities to shift focus and resources previously devoted to testing?
What other conditions lend themselves to at-home testing?
Where can companies shift efforts that were previously focused on reviewing orders?

Addressing Mental Health and the Other Epidemic

COVID-19 obviously emerged as the foremost health emergency of the past year. But it’s important to remember that the United States is still in the midst of an opioid addiction epidemic.

On top of that, COVID-19 has been hard on many people’s mental health. In response, many employers have made mental health a higher priority, and that trend is likely to continue, even as employees return to the workplace. In 2021, investors are likely to continue to emphasize digital health tools and service offerings that are focused on mindfulness and behavior health.

To learn more from Lisa and other thought leaders about the healthcare investing landscape heading into 2021, you can view a recording of The Deal’s webinar here.

Waiver of State Licensure Requirements for the Delivery of COVID-19 Countermeasures via Telehealth

by Lisa Mazur, Amanda Enyeart, Dale C. Van Demark and Marshall E. Jackson, Jr. | Dec 9, 2020 | Telehealth

In a fourth amendment to the March 17, 2020, Public Readiness and Emergency Preparedness Act (PREP Act), the US Department of Health and Human Services (HHS) has expanded access to COVID-19 Covered Countermeasures through telehealth and clarified the scope of liability protections provided by the PREP Act. In particular, the declaration is important to telehealth providers because it appears to preempt, under certain circumstances, state laws that have limited cross-border practice of medicine using telehealth. Healthcare providers should take note that the licensure exception and any immunity protections are limited to healthcare providers who are ordering or administering a Covered Countermeasure and there is no indication of intent to expand beyond these focused measures.

Access the article.

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