The Department of Health and Human Services once again (for the ninth time) extended the public health emergency this past month, stretching it beyond mid-July.

And, with broad-based support to avoid the "telehealth cliff," healthcare organizations and legislators have been working hard to ensure virtual care flexibilities outlast the PHE.

But sooner or later, that provision of the Public Health Service Act will draw to a close. Providers have been promised at least 60 days' notice. But even now, hospitals and health systems should be preparing proactively to meet the regulatory demands of a post-PHE future.

We spoke recently with Allison M. Cohen, a Washington, D.C.-based attorney in the health law practice of Baker, Donelson, Bearman, Caldwell & Berkowitz about what providers should be doing to ensure compliance when the PHE finally sunsets. Here's what she had to say.

Q. What impact will the newly extended PHE have on providers?

A. The extension of the public health emergency provides a temporary reprieve for providers by allowing them to maintain telehealth and other care delivery arrangements structured during the pandemic before waivers and regulatory flexibilities terminate. While the nation seeks to reopen and put COVID-19 behind us, providers are still addressing new variants and recovering from the financial and emotional impact of the pandemic. 

While it is important to carefully consider the most effective methods of providing care and the intended purpose behind various reimbursement, privacy, and fraud and abuse regulations, it is also clear that healthcare delivery has always and continues to evolve, and the regulatory framework needs to do the same.

Many providers are advocating for the extension of various waivers and flexibilities tied to the PHE. Additionally, several telehealth flexibilities (that generally expand Medicare coverage for telehealth services) have been extended 151 days (about five months) beyond the termination of the HHS PHE. 

While some changes to the telehealth regulatory framework have already been made permanent (e.g., expanded Medicare coverage of telehealth services furnished to patients in their homes for purposes of evaluating, treating and diagnosing mental health disorders), many remain temporary without further legislative action. It is hard to imagine that lawmakers will not make further changes to allow telehealth to be delivered without the many regulatory restrictions that existed pre-pandemic.

At the same time, it is important to recognize that some laws and regulations that were temporarily lifted will go back into effect, if they have not already. Given the numerous sources of authority for the various waivers and flexibilities, providers have to prepare to make any changes to telehealth arrangements necessary to ensure that they remain compliant with applicable federal and state laws and regulations when the PHE ends.

Q. What steps should providers take when it comes to preparing for the PHE's end?

A. Providers need to take proactive steps to mitigate legal risks associated with telehealth and virtual care delivery arrangements by developing a comprehensive understanding of both federal and state laws and regulations that apply to such arrangements. 

The challenge is to be able to identify the basis for various waivers and regulatory flexibilities in order to be able to effectively determine which laws and regulations will likely go back into effect, which have already been changed, and which may change in the future.

This includes making distinctions between the changes to the telehealth regulatory framework that were made through various mechanisms, including:

• Section 1135 waivers.

• Legislation or temporary regulatory flexibilities tied to the PHE.

• State government executive orders.

• Agency enforcement discretion.

As an example, under Section 1135 waivers, CMS has temporarily waived requirements that out-of-state telehealth practitioners must be licensed in the state where the patient is located when furnishing services in a state where the emergency is occurring. 

While licensure as a condition of payment is waived during the PHE if certain criteria are satisfied, this federal waiver explicitly does not have the effect of waiving state or local licensure requirements.

Early in the pandemic, many states issued executive orders that allowed out-of-state practitioners to provide services to patients in the state without being licensed in the state.  As many of these state executive orders terminate or are rescinded, in-state licensure requirements are going back into effect. 

As a result, even as the HHS PHE remains in place, practitioners may be engaging in the unlawful practice of medicine in a state if they are not appropriately licensed to practice on patients in that state under state laws, regulations and medical board requirements.

Another noteworthy distinction is that the Section 1135 waivers will end when the HHS PHE expires, but the Consolidated Appropriations Act, 2022 extended certain telehealth flexibilities for 151 days after the HHS PHE ends. The authority for many of the extended telehealth flexibilities generally comes from the Coronavirus Preparedness and Response Supplemental Appropriations Act and the CARES Act. The flexibilities that will be extended 5 months beyond the termination of the PHE are generally expansions of Medicare coverage, including the following:

• No geographic or originating site restrictions on the patient site.

• More practitioners can provider covered telehealth services (e.g., PTs, OTs, and SLPs).

• Periodic in-person visits (6 months before an initial telehealth visit, and every 12 months thereafter) are delayed for mental health telehealth services to be furnished to patients in their homes or audio-only.

While providers will have some additional time after the PHE ends to provide telehealth services without these coverage limitations going back into effect, they also have to be aware that it would take a legislative fix to expand Medicare coverage to telehealth services provided to patients in their homes and urban areas on a permanent basis.

Q. What do you see as the primary compliance issues providers will have to contend with?

A. Providers will have to comply with an array of state and federal requirements that can apply to the delivery of care through telehealth. Some key considerations include:

• State Laws and Licensure. When delivering care across state lines, providers will have to be aware of state requirements that practitioners generally have to be licensed in the state where the patient is located, or they may be engaging in the unlawful practice of medicine. Outside the blanket waiver, it is also a CMS reimbursement requirement that the practitioner must be licensed in the state.

• Federal rules. There can be Stark and Anti-kickback statute risks associated with providing telehealth equipment to physicians or other healthcare providers unless exceptions or safe harbors apply. Without temporary OCR enforcement discretion to use certain platforms for the good faith provisions of telehealth services, there are HIPAA requirements applicable to the technology platforms/apps that may be used to provide telehealth services.

• Reimbursement requirements and potential FCA Liability. If Medicare coverage requirements for telehealth services (e.g., originating site requirements) or the code requirements for other Communications Technology Based Services (e.g., must be an established patient outside the PHE) are not satisfied, and the provider knowingly submits claims for payment in violation of these requirements, the claims could be considered false claims. Additionally, any reimbursement resulting from these claims could be considered an overpayment. Once a provider has credible evidence of an overpayment, it must be reported and returned to avoid triggering FCA liability. Another legal consideration is whether there is civil monetary penalty risk under the Beneficiary Inducement CMP and the federal AKS that could arise from not charging patients co-insurance for the telehealth and other services furnished through telecommunications technology.

Q. What predictions do you have about the future of telehealth policy?

A. While telehealth will never replace in-person care, it will be integrated into care delivery similar to other healthcare innovations. It has been proven that telehealth and digital health solutions present opportunities to expand access to care and specialists in remote or underserved areas, monitor patients post-discharge, reduce readmissions, advance the adoption of new and innovative medical services and technologies, and to achieve better outcomes in value-based arrangements and models, and provide convenience and accessibility that patients are demanding.

The need for telehealth became even more acute during the COVID-19 pandemic, and its important role in the health care system has now been acknowledged by providers and payers, including the federal government.

Some service lines are more easily delivered via telehealth, but it would be challenging for both patients and providers to cease the provision and payment of various telehealth services in addition to, rather than in place of, in-person care. When telehealth is broadly framed to include the application of telecommunications networks and technological innovations to enhance care delivery, there is potential for significant growth. 

As health care providers operationalize arrangements to augment clinical care and improve patient satisfaction and outcomes, they will have to develop an in-depth understanding of the regulatory framework surrounding telehealth and other virtual services.

It is undeniable that the pandemic has sped the process of innovation by allowing providers to test new care delivery models. The experience and data derived from this challenging, but unique period will allow providers and policymakers to make informed decisions about how to maintain access to the most effective telehealth solutions in the future. 

Many of the limitations of the pre-PHE regulatory framework should be reconsidered to allow patients and providers to continue to experience the benefits of healthcare innovation after the COVID-19 public health emergency terminates.

Healthcare IT News is a HIMSS publication.