How Will the End of the PHE Affect Telehealth and Digital Health?

While some waivers have been extended for two years, other freedoms—including an important Ryan Haight Act provision—will end soon, forcing some providers to take action now.

With the Biden Administration announcing the end of the COVID-19 public health emergency (PHE) on May 11, healthcare organizations are assessing how their digital health and telehealth programs will be affected. While Congress put in place a temporary reprieve in its budget bill, certain freedoms and waivers will end soon.

"This is going to be a trying time" for health systems, says Jacob Harper, a partner in the Morgan Lewis law firm who focuses on the healthcare industry. "It's kind of a double-edged sword. Without knowing [what will happen with the extended waivers], it's really hard to evaluate what the future looks like when you don't know the long-term outcomes."

When the PHE was created in January of 2020 to help the nation deal with the growing pandemic, a  number of waivers and exemptions were put in place by federal and state regulators to help healthcare organizations expand and be reimbursed for digital health and telehealth services. The idea behind this was to allow providers to use virtual and connected health tools and platforms to reduce the spread of the virus and make sure consumers were able to access needed healthcare services.

As a result, telehealth use soared during the height of the pandemic, as providers launched new services and programs and consumers enjoyed the benefits of virtual on-demand healthcare. While in-person care is mounting a comeback, health systems are now adjusting to hybrid workflows that allow for in-person and virtual care.

But many programs are buoyed by those PHE waivers, especially those launched by the Centers for Medicare & Medicaid Services (CMS). A growing concern among healthcare executives is that many of these new programs won't be able to stand up on their own without the waivers or new regulations that improve telehealth use and coverage. Those programs may have to be shut down, cutting off patients from important healthcare services.

With the recent Congressional passage of the Consolidated Appropriations Act of 2023, several of those CMS waivers have been extended until the end of 2024. The wavers include that::

• Healthcare providers can bill Medicare for telehealth services regardless of the location of both the patient and provider (including the home)
• Audio-only telehealth services, such as phone calls, are reimbursable
• Federally qualified health centers (FQHCs) and rural health clinics (RHCs) can be reimbursed through Medicare for telehealth services as a distant site provider
• Hospice care providers can use telehealth to recertify their eligibility
• The list of healthcare providers allowed to bill Medicare for telehealth services is expanded to include physical and occupational therapists and speech language pathologists and audiologists
• Members of high-deductible health plans (HDHPs) and health savings accounts (HSAs) can use "first dollar coverage" for telehealth visits without first having to meet a deductible
• CMS' acute hospital care at home program remains in place

Harper says this is a reprieve in one sense, but it mainly kicks the can down the road.

"I don't think you can relax," he says, noting those waivers will still end in two years unless CMS or Congress takes further action. "You can't really take your foot off the gas pedal."

Other waivers and freedoms, meanwhile, will end on May 11. Chief among them is a waiver of the Ryan Haight Act's in-person exam requirement. Passed into law in 2008, the Ryan Haight Online Pharmacy Consumer Protection Act severely restricts the prescription of controlled substances, and requires an in-person exam by a qualified provider before those drugs can be prescribed via telemedicine. Enforcement is handled by the US Drug Enforcement Agency (DEA).

Writing in their Health Care Law Today blog, Thomas Ferrante and Rachel Goodman, partners with the Foley & Lardner Law Firm and members of the firm's Telemedicine & Digital Health Industry Team, say the waiver of the in-person exam during the PHE ensured that "millions of both established and new patients were able to receive medically necessary prescriptions via telemedicine."

"There have been efforts to amend the Ryan Haight Act and encourage the DEA to activate the telemedicine special registration rule before the PHE expires, including pending federal legislation," they wrote. "However, to date, the Ryan Haight Act has not been changed and the DEA has not activated the telemedicine special registration rule." 

"Thus, when the PHE expires on May 11, without further action on the part of the DEA, the in-person requirement is set to revert, without any special registration rule or other process established to ensure continuity of care," Ferrante and Goodman conclude. "Therefore, continued prescribing of controlled substances for patients never seen in-person, and only through virtual means during the PHE, will be prohibited and these patients would either need to be seen in-person or have their care transitioned to a local provider."

Because the pandemic coincided with—and helped propel—a surge in substance abuse and mental health issues, the last few years have seen a marked increase in telemental health and opioid and substance abuse programs using telehealth and digital health. The key to the success of those programs is the ability to prescribe medications via telehealth.

"I don't know how many of [those programs] are going to survive," Harper says.

Among those calling for action is the American Telemedicine Association (ATA).

"The ATA and [its lobbying group] ATA Action implore our government leaders to provide a sense of certainty to a huge cohort of individuals requiring access to important medications for substance use disorders and other necessary drugs via telehealth after May 11," Kyle Zebley, the organization's senior vice president of public policy and executive director of ATA Action, said in a press release. "Without a plan in place, these vulnerable populations will be left out in the cold, and we are quite sure this is not the intent of our government leaders."

“The ATA and ATA Action have been urging the [DEA] to release its rules for special registration for telemedicine, which will hopefully be a new pathway to continue providing this care post-pandemic," Zebley continued. "However, we are extremely concerned as those rules have been required since the original Ryan Haight Act was passed in 2008 and reiterated in statute by Congress in 2018, but we have yet to see them published. There is now an extreme sense of urgency with the public health emergency ending in only a few months.”

Other changes that will take place with the end of the PHE, according to Ferrante and Goodman, include:

Medicare payment parity. During the PHE, CMS increased reimbursement for telehealth services outside the hospital setting, such as in a patient's home, essentially allowing providers to receive the same payment for a telehealth service as they would for an in-person service. That will end with the PHE, thus reducing telehealth reimbursements outside the healthcare setting. This may prompt some providers to curb their telehealth services or focus more on in-person services.

Telehealth and remote patient monitoring (RPM) co-payment waivers. The US Department of Health and Human Services' Office of the Inspector General (OIG) issued a policy statement during the PHE that they would not enforce sanctions under the Anti-Kickback Statute for cutting or waiving deductibles and co-payments (cost-sharing) for telehealth or RPM services for Medicare patients.

"The guidance documents expressly tie this waiver to the duration of the PHE," Ferrante and Goodman wrote in their blog. "Thus, unless the OIG issues additional guidance or an extension, after May 11, healthcare providers offering telehealth or RPM services to Medicare beneficiaries may no longer reduce or wave any cost-sharing obligations that patients may owe for such services. Digital health companies without payment and collection mechanisms for these payments will need to act swiftly to operationalize new process to ensure these amounts are charged and collected."

RPM program expansion. During the PHE, CMS allowed RPM programs to expand beyond established patients and include (and bill for) new patients. That ends on May 11, and providers will have to conduct new patient evaluation and management services before adding anyone to their RPM programs. This could slow the growth of RPM adoption.

Virtual direct supervision. CMS also changed direct supervision guidelines during the PHE to allow a "supervising professional" to use audio-visual telemedicine to remotely supervise a procedure. CMS did not extend this policy beyond this year in its 2023 Physician Fee Schedule, so virtual direct supervision will no longer be allowed after 2023.

HIPAA enforcement. According to Ferrante and Goodman, the HHS Office for Civil Rights (OCR) relaxed its enforcement of the Health Insurance Portability and Accountability (HIPAA) rules during the PHE,  enabling providers to use telehealth in good faith even if they didn't meet HIPAA standards (for example, the use of certain technologies for virtual visits). After May 11, the OCR has said it will resume enforcing those guidelines.