Pandemic Silver Lining: Federal Telehealth Regulations Relaxed – At Least for Now

Last week I wrote about the big changes to Medicare telehealth coverage during the COVID-19 Public Health Emergency (PHE). But Medicare coverage is only part of the story.

Here’s an overview of several other temporary telehealth policy changes and federal telehealth programs you should know about. (This is not a comprehensive list but rather an overview of some of the most notable actions taken so far. Before engaging in any telehealth encounter and relying on a given regulation, I recommend you check the appropriate website or reach out to your regional Telehealth Resource Center for the most up-to-date information.)

The US Drug Enforcement Agency and Telemedicine Prescribing

As you may know, the DEA was ordered by Congress and the president over a year ago to come up with a Special Registration for Telemedicine, which would allow for the prescription of controlled substances via telemedicine without all the hoops that providers are currently required to jump through. The deadline for this Special Registration was last October, and nothing happened … until the pandemic. In response to the declared public health emergency the DEA stated it will allow DEA-registered practitioners to prescribe Schedule II through V controlled substances without having to conduct an in-person medical evaluation first, with certain, common-sense limitations, for the duration of the PHE.

At the end of March, the DEA took it even further and issued a policy saying Opioid Treatment Programs and DATA-waivered practitioners can prescribe Buprenorphine to new patients with opioid use disorder on the basis of a telephone evaluation, as long as the practitioner feels a phone call is adequate for evaluation, for the duration of the PHE. Given the DEA’s past record of inaction on looseing telehealth restrictions, this one surprised me.

The US Department of Health and Human Services – Beyond Medicare Expansion

In addition to issuing waivers that allowed for massive Medicare expansion of telehealth during the pandemic, HHS has taken other actions to facilitate telehealth.

• The HHS Office of Civil Rights has decided it’s not going to penalize providers for using non-HIPAA compliant platforms for telehealth, as long as the platforms are not public-facing and it’s “good faith” provision of telehealth. This is aimed at providers and patients who need to get telehealth started up immediately, and it’s only for the duration of the PHE. If you’re a provider already using a HIPAA-compliant platform, keep using it! And if you’re starting services and you can use a HIPAA-compliant platform, do – you’re going to have to move to one after the PHE is over anyway.
• Meanwhile, the HHS Office of the Inspector General (OIG) has decided to allow providers to reduce or waive beneficiary cost sharing (such as copays and deductibles) during the PHE. Normally, this could violate the federal Anti-Kickback Statute and other laws.
• The OIG also won’t penalize providers that lease equipment and pay for physician services without documenting that it’s all being done at Fair Market Value during the PHE. However, always document as much as you can no matter what just to be safe.

The Federal Communications Commission and Broadband Access

The FCC has come out with the Keep Americans Connected Pledge, which more than 700 ISPs and wireless providers have signed, including many Arizona providers. Companies pledge, for the next 60 days, not to cut off residential or small business service due to inability to pay due to PHE disruptions, to waive late fees related to the PHE, and to open their Wi-Fi hotspots to any American who needs them.

A few other actions the FCC has taken to help with telehealth connections include:

• Granting several wireless companies temporary use of additional spectrum to help meet demand
• Temporarily waiving Universal Service gift rules
• Adding more than $42 million in funding for the Universal Service Rural Health Program and extending the application window and other deadlines

And finally, the CARES Act gave the FCC $200 million  to fund nonprofit and public healthcare provider broadband and connected devices. The FCC started taking grant applications April 13, so it’s important to apply asap.

The US Food and Drug Administration and Device Regulation

In March, the FDA issued a new policy allowing certain FDA-cleared, non-invasive, vital-sign measuring devices to be used by healthcare providers to monitor patients remotely for the duration of the PHE.

Also in March, the FDA issued some clarification on which apps and software it considers medical devices and which it doesn’t and will not regulate, including telemedicine platforms.

In April, the FDA relaxed certification on some prescription-only connected health tools designed to treat depression and other mental health conditions during the PHE.

So, what does all this mean for telehealth regulation after the PHE is over?

That’s an unknown. However, many of these policy changes are just a step or two beyond what was already in the works. Before the PHE, the DEA was already overdue on creating the Special Registration for Telehealth, and I hope that by the end of the PHE they’ll have evidence that using telemedicine to prescribe controlled substances does not add to the opioid epidemic. Before the PHE, the FDA was already swamped with device applications and had already worked out a risk-based enforcement system. Before the PHE, the OIG was already proposing changes to the Anti-Kickback Statute to facilitate the use of telehealth and CMS was proposing permanent exceptions to the Stark Law for value-based care arrangements.

With that in mind, I wouldn’t be surprised to see, if not these exact waivers in place, at least some movement toward more flexibility for telehealth. It will be important to keep up to date on all changes – both now and as the PHE abates.A good resource to help you do this is our Telemedicine COVID-19 Resources web page, which has much more detail and multiple resources, and which we update regularly.