The pandemic-induced telehealth guidelines are coming up for renewal again, potentially suggesting a tightening of rules and therefore less access — and both clinicians and patients are unsettled.
More than 300 groups from the American Telemedicine Association, a trade association representing telehealth companies and clinical organizations, sent a letter to Congress urging lawmakers to extend Covid-era rules.
In late August, new uncertainties arose when Politico Pro predicted a tightening, Modern Healthcare reported.
“Anxiety among telehealth stakeholders soared last Wednesday, when Politico Pro reported the [Drug Enforcement Administration] intends to produce a regulation that would narrow the list of drugs that remote providers can prescribe and require them to verify that patients aren’t seeking medicines to misuse them. That report is unconfirmed and was attributed to an unnamed former D.E.A. official,” the Modern Healthcare report said.
“According to Politico Pro, the D.E.A. is planning to impose tighter restrictions on providers who remotely prescribe Schedule II drugs such as Vicodin, OxyContin, Adderall and Ritalin and end remote prescribing of Schedule III-V drugs such as codeine, Xanax and Ambien. The agency would also limit providers to remotely prescribing only 50% of their total prescriptions, the publication reported. The DEA did not respond to a request for comment.”
The Centers for Medicare and Medicaid Services recommended in July that many telehealth flexibilities be extended through the end of calendar year 2025. The recommendations are detailed in this post from the Baker and Donelson law firm, primarily covering Medicare beneficiaries, providing “some level of certainty regarding the regulatory landscape while we await legislative changes that would be necessary to permanently remove certain statutory constraints” on telehealth services such as the originating site requirements,” the law firm wrote.
Guidelines expiring
When the pandemic struck, telehealth quickly became the norm, after years of pushback from the healthcare system. Now everybody has gotten used to virtual care — doctor visits and telehealth prescribing of medications — and the in-the-breach setting of regulations seemed to work pretty well. But the telehealth guidelines were modified only by temporary extensions, and they are set to expire later this year.
Stat News talked with the head of a provider of pulmonary rehabilitation about the possiblity that the telehealth flexibilities would not be extended. “What we’re seeing is that the urgency of passing this isn’t commensurate with the need for these patients to have clarity around their health care,” said Victor Sadauskas, Kivo’ Health’s chief executive. ”We’re dealing with people’s health care, dealing with people’s lives, dealing with people’s ability to breathe. For that, you can’t have lack of clarity.”
Telemedicine practices during the pandemic started out being somewhat chaotic, partly because the healthcare system had long insisted that a doctor and a patient need to be in the same place at the same time physically for good medicine to take place. When Covid made that impractical and even undesirable, doctors, hospitals, urgent cares and others scrambled to come up with a workable system.
In some cases the payment system was the problem. In other cases, licensing across state lines was the problem — but many systems and doctors got credentials in other states, to make it work. Regulations of who had to be credentialed where seemed to work pretty well, for a time. Some states issued waivers, which lasted for a while; others made streamlined licensing processes.
Rollbacks in access
Then one by one, starting as early as 2021, both legislatures and medical boards began rolling back telehealth access, reverting to pre-pandemic rules.
The Drug Enforcement Administration, which is in charge of telehealth regulations at the federal level, extended telehealth flexibilities last October. The extension is due to expire on Dec. 31 of this year, D.E.A. and the Department of Health and Human Services said. A bill to extend flexibilities cleared a House Committee in August, but it has not yet passed.
The decision to extend last year had been eagerly anticipated by patients and doctors alike, given that the reinstatement of tougher regulations for telehealth in general and prescribing by telemedicine in specific promised to create difficulties for people accustomed to getting medications easily.
The conversation about this topic also questioned why the Drug Enforcement Administration should be in charge of deciding how people get their medications.
ADHD medications
One big factor is the rapid expansion in prescribing ADHD medications over telehealth. The surge in ADHD diagnoses during the pandemic came partly because of the telehealth flexibilities.
Some people think that flexibility led to overprescribing, including the spectacular flameout of a company called Done, which had that as its business model. Its founder, Ruthia He, and clinical leader, David Brody, were arrested and charged with fraud in June, accused by federal authorities of conspiring to provide easy access to Adderall and other stimulant medications.
They were accused of arranging for the prescription of more than 40 million stimulant pills, the Justice Department said, and targeted “drug seekers.”
““As alleged, these defendants exploited the COVID-19 pandemic to develop and carry out a $100 million scheme to defraud taxpayers and provide easy access to Adderall and other stimulants for no legitimate medical purpose,” said Attorney General Merrick B. Garland. “Those seeking to profit from addiction by illegally distributing controlled substances over the internet should know that they cannot hide their crimes and that the Justice Department will hold them accountable.”
40 million pills
“As alleged in the indictment, the defendants provided easy access to Adderall and other stimulants by exploiting telemedicine and spending millions on deceptive advertisements on social media. They generated over $100 million in revenue by arranging for the prescription of over 40 million pills,” said Principal Deputy Assistant Attorney General Nicole M. Argentieri, head of the Justice Department’s Criminal Division. “These charges are the Justice Department’s first criminal drug distribution prosecutions related to telemedicine prescribing through a digital health company.”
Access was granted to medications via a monthly subscription fee, the Justice Department said.
Done “obtained subscribers by targeting drug seekers and spending tens of millions of dollars on deceptive advertisements on social media networks. They also allegedly intentionally structured the Done platform to facilitate access to Adderall and other stimulants, including by limiting the information available to Done prescribers, instructing Done prescribers to prescribe Adderall and other stimulants even if the Done member did not qualify, and mandating that initial encounters would be under 30 minutes.”
The Done prosecution, while the first of its kind, shows that the regulatory environment is still uncertain about telehealth, which makes it possible that the flexibilities will not be renewed, or that new regulations may be proposed in their place.
State by state
Further complicating the situation, different insurers take different approaches to what they will cover. And, the rules work differently from state to state. If you live in New Jersey, can you have a telemedicine provider in New York or Pennsylvania? If you live in New York, can you keep your long-distance cancer provider in Pennsylvania?
Here’s a deep dive and an overview from the law firm Foley and Lardner: A 50-state assessment of laws. What’s approved and what’s not. Foley is a national expert in legal matters relating to health.
We have written about this before, documenting court cases in which patients sought to keep arrangements with out-of-state clinicians, for example, to continue cancer care. Here is the Foley and Lardner overview.
Here’s our piece about the changes for people with specialists far away.
