In a world changing faster than we ever thought possible, the regulations surrounding telepsychiatry are evolving at lightning speed. The demand for telehealth service has exploded in recent weeks and it is imperative to know the rules and regulations as organizations rapidly adapt to this form of care. Below is a brief highlight of the most relevant policies impacting the telepsychiatry industry today. We will continue to update this post in the coming weeks as the situation evolves.
Disclaimer: The information on this page is a summary of the current laws, regulations, and guidance and not to be used as a comprehensive legal document. The information is continually changing so we encourage you to raise any questions to your legal counsel about how it may be applicable to your facility or organization.
Content last updated on May 4, 2020
With the Ryan Haight Act, can telemedicine now be used more broadly to prescribe controlled substances?
Yes, since the Secretary of the Department of Health and Human Services issued a public health emergency, that “practice of telemedicine” exemption within Ryan Haight can be met. Per the DEA, for as long as the Secretary’s designation of a public health emergency remains in effect, DEA-registered practitioners may issue prescriptions for controlled substances to patients for whom they have not conducted an in-person medical evaluation, provided all of the following conditions are met:
- The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice.
- The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system.
- The practitioner is acting in accordance with applicable Federal and State law
Provided the practitioner satisfies the above requirements, the practitioner may issue the prescription using any of the methods of prescribing currently available and in the manner set forth in the DEA regulations. Thus, the practitioner may issue a prescription either electronically (for schedules II-V) or by calling in an emergency schedule II prescription to the pharmacy, or by calling in a schedule III-V prescription to the pharmacy.
Has there been any guidance related to being able to prescribe when lab tests are required?
The FDA released guidelines related to the use of REMS-required lab testing in order to prescribe certain controlled substances (including Clozapine). They state that providers should consider whether there are compelling reasons not to complete lab tests, or delay them and use best medical judgment in weight benefits and risks of continuing treatment in the absence of lab testing.
Furthermore, the FDA does not intend to take action against those providers for the duration of the PHE for failing to adhere to REMS requirements for lab tests.
What changes have been made to HIPAA?
Effective immediately, the HHS Office for Civil Rights (OCR) will exercise enforcement discretion and waive penalties for HIPAA violations against health care providers that serve patients in good faith through everyday “non-public facing” communications technologies, such as FaceTime or Skype, during the COVID-19 nationwide public health emergency.
UPDATED (04/02/2020): The enforcement waiver also extends to failure to enter into a BAA with vendors of non-public facing remote communication and other non-HIPAA compliance remote communication products.
“Public facing” remote communications that are not appropriate to use include Facebook Live, Twitch, TikTok and are not subject to the enforcement waiver
Enforcement waivers apply only to covered entity healthcare providers and not health plans or healthcare clearinghouses.
Furthermore, to what extent the enforcement waiver will apply to these vendors and products will analyze whether there was end-to-end encryption, support individual user accounts, logins, and passcodes to help limit access and verify participants and/or permit participants to assert some control over the interaction.
Are licensure requirements being waived?
Individual states are providing guidance on licensure requirements on an ongoing basis. Currently, 49 states and DC have either waived their licensure requirements, as long as the clinician holds a medical license in another state, or have implemented a temporary emergency licensure process. Arkansas is the only state that has not waived licensure requirements in some form during the PHE. These actions are meant to remove barriers for clinicians to provide services in other states where they do not hold a license or to create an application process wherein applications are reviewed within a very short period of time.
However, waived licensure requirements and the temporary emergency license are only in effect until the public health emergency is terminated or otherwise stated. Ideally, if a clinician is granted an emergency license in a state that will be a permanent assignment for the clinician, they should still proceed with the full, permanent licensure during this time.
Only a handful of states are expediting the process to obtain a full, permanent license. Kansas, for example, is leveraging the Interstate Medical License Compact (IMLC) to expedite the licensure process for physicians who have received a license in another state through the compact within the past 365 days. Wisconsin is also communicating that they are reviewing full applications more frequently.
For more information, please refer to the FSMB’s resource, “States Waiving Licensure Requirements/Renewals in Response to COVID-19”. The resource is updated daily.
UPDATED (04/17/2020): In response to the declaration of a national emergency and emergency declarations by all states, many health care entities have taken unprecedented steps regarding licensure portability and the deployment of skilled health workforce resources. These health care entities rely on the NPDB to make informed hiring, licensing, and credentialing decisions. To support these entities during this national emergency, the NPDB is temporarily waiving query fees (both one-time query and continuous query).
The waiver is retroactive from March 1, 2020, through May 31, 2020. The NPDB will issue query credits to reimburse entities that conducted queries (one-time and continuous) between March 1 and the implementation of the fee waiver.
Are states granting extensions on existing provider license renewals and/or to fulfill CME credit requirements?
States may begin to extend any renewal periods for provider licensure renewals or adjust requirements to fulfill CME requirements as administrative offices are closing or the inability to attend live trainings (e.g. Illinois has extended renewals through September 30 if the licensee was to renew between March 1-July 31).
Are sites able to expedite the privileging process?
Guidance on this topic is still ongoing. Under the Department of Health and Human Services (HHS) and the Health Resources and Services Administration (HRSA), if there is a public health emergency declared, health centers that receive funding under Section 330 of the Public Health Service Act (PHSA), such as FQHC’s and CHC’s, may grant providers temporary privileges by the CEO of the impact health center and reviewed by the applicable clinical department head and/or CMO. The relevant areas that may allow for expedited review and verification that could occur that includes confirming: Identity, Professional Credentials, Claims History, and Fitness/References. Additionally, the AHA (American Hospital Association) sent a letter to HHS on Monday requesting the ability to have expedited or presumptive credentialing and privileging (along many other exceptions which some have been addressed - e.g. HIPAA, Telehealth Technology, etc.).
UPDATED: Additionally, if a state has requested for a Section 1135 waiver, they may include the ability to help facilitate any credentialing and privileging that is needed with payors to help expedite them to submit claims for services rendered by the providers. Currently 49 states have applied for and granted such waivers.
What changes have been made to Medicare telemedicine restrictions?
Medicare has temporarily expanded previous restrictions on telemedicine services. Firstly, the Coronavirus Preparedness and Response Supplemental Appropriations Act allowed the Secretary of Health and Human Services (HHS) to waive the geographic and originating site requirements within Medicare. With this change, Medicare beneficiaries can receive services in their own homes without having to be located in a rural or health professional shortage area. Furthemore, with the recent enactment of the CARES Act, the modality requirement is now open to phone based, audio-only services. Previously, only real-time, audio-visual technology could be used. The CARES Act also relaxed the requirement that the provider must have seen a patient within the past three years in order to be reimbursed. For more information, see the Center for Connected Health Policy’s Telehealth Coverage Policies in the Time of COVID-19.
UPDATED (05/01/2020): CMS released a second round of changes that further expand their telehealth policies during the public health emergency.
Modality Use and Payments: One of the biggest changes CMS made is to waive the requirement that services had to be provided using video-technology. Now, audio-only telephone services can be utilized for evaluation and management services and behavioral health counseling and education services. CMS is also increasing payments for these telephone visits to match payments for similar office and outpatient visits. For a list of eligible codes and whether or not they qualify for audio-only, please refer to CMS’ list of covered telehealth services for PHE.
Additional Originating and Distant Site Changes: Hospitals can now qualify for the originating site facility fee for telehealth services furnished by hospital-based clinicians to Medicare beneficiaries registered as hospital outpatients even when the patient is at home. Furthermore, CMS is now paying for telehealth services provided by RHCs and FQHCs serving as the “distant site." Previously, these clinics were not paid if they were serving as the “distant site,” only if they were the “originating site.”
Types of Providers Eligible for Telehealth Reimbursement: Related to the types of clinical practitioners that can furnish Medicare telehealth services. Prior to the PHE, typically only physicians, nurse practitioners, physician assistants, and certain others could deliver telehealth services. Now, other providers including physical therapists, occupational therapists, and speech language pathologists would also qualify for reimbursable services.
Changes to the Rulemaking Process: when CMS previously added new services that would be reimbursable via telehealth, they would use its rulemaking process. CMS is changing its process during the PHE to speed up the ability to add telehealth services on a sub-regulatory basis by considering requests from practitioners now learning to use telehealth and its effects.
Are state Medicaid programs also making changes during this time?
Individual state Medicaid programs are currently coming out with guidance on an ongoing basis. States are applying for Section 1135 waivers in order to make changes and offer flexibilities in providing resources to their state beneficiaires. Florida, for example, was the first state to submit and be approved for their Section 1135 waiver request to remove unnecessary barriers on clinicians such as prior authorization requirements. CMS has now approved an additional 48 state Medicaid waivers. These waivers are effective as of March 1, 2020 and will end once the public health emergency has been terminated.
UPDATED: Individual state Medicaid reimbursement policies continue to be updated. The Center for Connected Health Policy (CCHP) has provided a good resource on what changes each state has enacted.
What type of virtual services and what codes may apply for Medicare beneficiaries?
CMS has provided a fact sheet of 3 ways that the patient may receive care and what codes the provider may submit which is summarized in the chart below. Additional CPT codes and guidance from CMS related to updated codes can be found here.
What is the Coronavirus Aid, Relief, and Economic Security (CARES) Act doing related to helping healthcare providers and organizations receive assistance to help sustain operations and/or increase access to patients through alternative services like telehealth?
As part of the CARES Act, healthcare providers and facilities who received Medicare fee-for-service (FFS) reimbursements in 2019 may begin to receive payments for relief (not loans) to assist with having to cease operations or who are struggling to keep their doors open from patients delaying care or cancelling services. Here is a link that provides more information including eligibility and how the payments are distributed.
UPDATED (05/01/2020): On April 10, as part of the CARES Act, the FCC announced began accepting applications to assist healthcare providers with funding to purchase and receive the connectivity and devices they need to care for patients remotely. In order to receive funding, providers may qualify as part of a consortium or as an Healthcare Provider (HCP) site (e.g. Community Health Center, Rural Health Clinic, Non-profit hospital).
What are advocacy groups and other organizations hoping to propose for long-term changes?
IMLC Adoption: The ERISA Industry Committee (ERIC), a national advocacy organization that represents large employers that provide health, retirement, and other benefits to their nationwide workforces, has sent letters to the governors of the 21 states that are not currently members of the Interstate Medical Licensure Compact (IMLC). The letters urge the governors to introduce legislation to join the compact, which would allow qualified providers to receive a medical license from any participating state through an expedited licensure application process.
The states that received these letters include Alaska, Arkansas, California, Connecticut, Delaware, Florida, Hawaii, Indiana, Louisiana, Massachusetts, Missouri, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Rhode Island, South Carolina, Texas, and Virginia. To view a sample letter, click here.