SubscribeThe 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.
COVID-19
Trending in Telehealth: April 25 – May 1, 2023
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
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
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:
Preparing for the End of the COVID-19 Emergency: Tri-Agencies Issue FAQs to Assist Plans and Issuers
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.
Staying Connected: An Update on Medicare Reimbursement for Telehealth Services After the PHE
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.
CMS Addresses Virtual Care Expansion in CY 2022 Medicare Physician Fee Schedule Proposal
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.
Three Digital Health Trends Affecting Investors in 2021
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
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.
National Telehealth Takedown Highlights Opportunity for Providers to Enhance Compliance Efforts
The US Department of Justice and the US Department of Health and Human Services Office of Inspector General recently announced a significant healthcare fraud takedown involving $4.5 billion in allegedly false and fraudulent claims involving telehealth. The allegations involved telehealth executives paying healthcare providers to order unnecessary items and services, as well as payments from durable medical equipment companies, laboratories and pharmacies for those orders. While the alleged conduct is not representative of the legitimate and crucial telehealth services offered by the vast majority of healthcare providers, the government’s continued focus on telehealth arrangements, combined with the ongoing expansion of coverage for telehealth services, provides an important opportunity for healthcare providers to evaluate their telehealth service offerings and arrangements and to further enhance their related compliance activities.
In Depth
On September 30, 2020, the US Department of Justice (DOJ) issued a press release describing the largest national healthcare fraud and opioid enforcement action in the DOJ’s history (the Takedown). The Takedown involved coordination with the US Department of Health and Human Services Office of Inspector General (OIG) and other federal and state law enforcement agencies, and resulted in cases against more than 345 defendants in 51 judicial districts. The government charged the defendants with participating in healthcare fraud schemes involving more than $6 billion in alleged losses to federal health care programs, with the vast majority of alleged losses ($4.5 billion) stemming from arrangements involving alleged “telefraud.”
According to the DOJ press release, a recently announced National Rapid Response Strike Force led the initiative focused on telehealth. The National Rapid Response Strike Force is part of the Health Care Fraud Unit of DOJ’s Criminal Division Fraud section, and its mission is to “investigate and prosecute fraud cases involving major health care providers that operate in multiple jurisdictions, including major regional health care providers operating in the Criminal-Division-led Health Care Fraud Strike Forces throughout the United States.”
Background
In recent years, the government has increasingly focused on alleged healthcare fraud schemes involving telehealth services. In connection with the Takedown, OIG issued a fact sheet and graphic highlighting the increase in “telefraud” arrangements leveraging “aggressive marketing and so-called telehealth services.” The individuals charged in the Takedown included telehealth company executives, medical providers, marketers and business owners who allegedly used telemarketing calls, direct mail, and television and internet advertisements to collect information from unsuspecting patients.
Many of the cases involved telehealth executives who allegedly paid healthcare providers to order unnecessary durable medical equipment (DME), genetic and other diagnostic testing, and medications, either without any patient interaction or with only a brief phone call. The government alleged that the arrangements involved kickbacks to telehealth executives after the DME company, laboratory or pharmacy billed Medicare or Medicaid for items and services that the government asserts were often not provided to beneficiaries or were “worthless to patients . . . and delayed their chance to seek appropriate treatment for medical complaints.”
DOJ provided a [...]
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