Telehealth has emerged as a crucial lifeline during the COVID-19 public health emergency, mitigating both the spread of disease by infected individuals and the risk of becoming infected for healthy patients. Recognizing this, during March and April, policymakers on Capitol Hill and across federal agencies helped usher in a new era for telehealth and remote care by removing antiquated restrictions, issuing new guidance documents, and removing additional barriers to care.
The first three legislative packages to address the pandemic have each included major policy reforms for telehealth access during the pandemic. The Department of Health and Human Services (HHS) has acted on new authority to make sweeping policy changes both through activation of their Section 1135 waiver authority under the public health emergency and through explicit authority given by Congress, most notably in the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
This alert summarizes the federal policy changes made to increase access to telehealth during the pandemic. Many changes relate to the Medicare program, as it is run by the federal government and happened to also have the most restrictive policies on telehealth. Changes have also been made to other federal programs and policies that impact providers regardless of the payer, such as changes to controlled substances policies and Food and Drug Administration (FDA) regulation of devices.
While most policies are temporary during the public health emergency, our health care system is being transformed by the ability to practice virtually, and Congress should encourage that transformation by updating policies to ensure continued access to telehealth beyond the scope of this pandemic.
Note: We will update this article to reflect new policy changes, resources and information to help you keep pace with the evolving telehealth policy landscape.
New Funding and Resources to Support Telehealth Access and Infrastructure
- A new online resource, www.telehealth.hhs.gov, has been created to help the public understand telehealth and to encourage its uptake.
- The CARES Act provides $27 billion for HHS’s Public Health and Social Services Emergency Fund for Coronavirus measures, including telehealth access and infrastructure.
- Some of this funding is dedicated to providers serving the uninsured, including via telehealth. Claims can be filed here.
- The CARES Act provides an additional $180 million for the Health Resources and Services Administration (HRSA)’s telehealth programs.
- The CARES Act provides $200 million for the Federal Communications Commission (FCC) to support health care providers. On April 2, 2020, the FCC issued an Order establishing a COVID-19 Telehealth Program designed to help providers maximize connected care services.
- In the same Order, the FCC voted to go forward with its long-awaited $100 million “Connected Care Pilot Program.”
Relaxing Licensing Requirements
- CMS removed the Medicare requirement that providers be licensed in the state where the patient is, deferring to state licensing requirements.
- HHS Secretary Alex Azar sent a letter to all 50 governors encouraging flexibilities to allow licensed providers to practice across state lines.
Relaxing Restrictions on Remote Prescribing of Controlled Substances
- The Drug Enforcement Administration (DEA) loosened remote prescribing restrictions, enabling providers to prescribe controlled substances using telemedicine without having a prior in-person medical evaluation as otherwise required by the Ryan Haight Online Pharmacy Consumer Protection Act.
Policy Updates to Increase Access to Telehealth and Remote Patient Monitoring in Federal Programs
- Through new authority from Congress, the Secretary has waived the geographic site restrictions on Medicare telehealth services to allow beneficiaries to receive services in new locations, including the home. CMS has allowed for more services to be delivered via telehealth. Providers may furnish telehealth services to new and established Medicare patients.
- Certain virtual check-ins and behavioral health and patient education services may be done by telephone. CMS increased reimbursement for these services to reflect the in-person cost. CMS is also waiving the video requirement for certain telephone evaluation and management services and adding them to the list of Medicare telehealth services.
- CMS is allowing physicians to supervise their clinical staff using virtual technologies when appropriate, instead of requiring an in-person presence.
- According to CMS Guidelines, remote patient monitoring (RPM) can be used for patients with both acute and/or chronic conditions. Additionally, RPM can be provided to new patients as well as established patients.
- Hospice providers can provide services to a Medicare patient receiving routine home care through expanded telehealth services, and the CARES Act allows qualified providers to use telehealth to fulfill hospice recertification requirements for face-to-face visits.
- Home health agencies can provide more services to beneficiaries using telehealth.
- The CARES Act allows Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) to serve as “distant site” providers for telehealth in the Medicare program.
- CMS delayed Medicare quality reporting requirements.
- CMS has allowed new providers to deliver telehealth services, including physical therapists, occupational therapists and speech language pathologists.
- Hospitals may bill for services provided remotely by hospital-based practitioners to Medicare patients registered as hospital outpatients, including when the patient is in their home.
- CMS made an administrative change that allows new telehealth services via Medicare to be added on a sub-regulatory basis, speeding up the process for Medicare patients to begin accessing new services via telehealth.
- CMS is allowing Medicare Advantage organizations and other organizations that submit diagnoses for risk-adjusted payment to submit diagnoses for risk adjustment that were obtained during telehealth visits.
Indian Health Service
- The CARES Act sent over $1 billion to the Indian Health Service (IHS) to improve services, including mobile health and telehealth.
- IHS expanded access to telehealth services and telehealth training across service units.
Medicaid and CHIP
- CMS released a new toolkit for states to help accelerate adoption of broader telehealth coverage policies in the Medicaid and Children’s Health Insurance Programs (CHIP).
Department of Veterans Affairs
- The CARES Act expands telemental services at the Department of Veterans Affairs (VA) and expands broadband access for veterans to use telehealth.
- The CARES Act improves access to telehealth in the HUD-VASH program for homeless veterans.
- The CARES Act waives the in-person visit requirement for the Veteran Directed Care program and allows telehealth and phone calls as an alternative.
All Federal Health Care Programs
- HHS Office of Inspector General (OIG) notified physicians and other practitioners that they will not be subject to sanctions for reducing or waiving any cost-sharing obligations beneficiaries may owe for telehealth.
- HHS Office for Civil Rights (OCR) waived potential penalties for HIPAA violations against health care providers who serve patients through everyday communications technologies. This action applies to widely available applications with two-way audio and video capabilities, such as FaceTime or Skype.
High Deductible Health Plans
- The CARES Act allows high-deductible health plans with a health savings account to cover telehealth services before the member reaches his or her deductible.
Loosening Regulatory Requirements on Low-Risk Devices
- The FDA issued updated guidance that allows for faster entry into the market for remote monitoring devices.
- On April 14, the FDA issued guidance that aims to improve availability and accessibility of two types of digital health products for mental health care (see our alert for a closer look at this guidance):
- Prescription digital therapeutics providing computerized cognitive behavioral therapy (CBT) for psychiatric disorders.
- Low-risk wellness apps designed to address mental health needs.
As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.