On this Ropes & Gray podcast, health care partner Devin Cohen and counsel Leslie Thornton discuss the recent developments and trends related to at-home care coming out of the public health emergency (PHE). They talk about impacts of pandemic-era waivers and flexibilities, focusing on telehealth—including on state licensure, telefraud, HIPAA, and hospital-at-home—remote prescribing, and clinical trials, as well as the future of these flexibilities as we exit the PHE.
Transcript:
Leslie Thornton: Hello, and welcome to today's podcast. My name is Leslie Thornton, and I'm counsel in Ropes & Gray's health care practice group based in Los Angeles. My practice focuses on all things research and development, including digital health issues like telehealth and artificial intelligence, as well as health privacy. And, like many in our group, I represent a diverse group of health- and research-focused organizations, including academic medical centers and universities, tech and biotech, and pharma and device companies.
With me today is Devin Cohen, a partner in the health care practice group based in Boston. Devin represents providers, payors, and investors in value-based care collaborations, alternative payment methodologies, and vertical integration transactions that require navigating federal and state insurance requirements. Devin also counsels a variety of stakeholders in the clinical trial and research space exploring joint research relationships, expansion and government funding opportunities, as well as fraud and abuse in compliance research.
Leslie Thornton: Great—thanks, Devin. So, when we think about the impact of the public health emergency (PHE) on at-home care, telehealth is really the first thing that comes to mind for me and the prominence it gained during the pandemic out of necessity.
Devin Cohen: Definitely. There was a telehealth boom as COVID-related restrictions set in and with it, a lot of flexibilities surrounding the provision of telehealth services. During the public health emergency, Medicare patients were eligible for expanded access to telehealth services thanks to federal waivers to traditional reimbursement requirements as well as to conditions of participation. The Consolidated Appropriations Act of 2023 (CAA) extended a lot of these waivers through the end of 2024, permitting things like ongoing access to telehealth services even outside of rural regions, flexibility for patients to receive hospital-based services at home, and permitting continued use of audio-only technology in certain circumstances.
These are just a few examples of how CMS (Centers for Medicare and Medicaid Services) responded to the pandemic by giving providers and patients some leeway to ensure health care services are readily available at such a crucial time. And the availability of telehealth has become so effectively ingrained in the consumer health care experience in America, it really does seem that the Centers for Medicare and Medicaid Services and commercial payors are still reacting to its boom from over the past three years.
Leslie Thornton: That's interesting, Devin. Government payors seem to be comfortable with the use of telehealth generally but also want to be careful about implementing any permanent rules and regulations in this space, so it seems they are kind of kicking the can with these temporary waivers.
You mentioned the impact of the Consolidated Appropriations Act on Medicare Conditions of Participation. What exactly was "waived" under the CAA?
Devin Cohen: Let's start with Conditions of Participation. Conditions of Participation are requirements that health care providers need to meet to participate in Medicare, Medicaid or other federal health care programs. Non-compliance can result in all kinds of sanctions, starting from monetary penalties to increased reporting requirements—to the rare exclusion. CMS waived a lot of those conditions during the public health emergency. There are too many to name here, but some examples include physical environment requirements (like for surge capacity and patient quarantine), medical record services requirements, utilization review, bed and length-of-stay limits, and that licensed nursing services are immediately available 24–7. Many, but not all, of these waivers ended with the sunset of the public health emergency or are scheduled to end on December 31 of next year under the Consolidated Appropriations Act. But, providers subject to Conditions of Participation who likely adjusted their policies related to anything from patients' rights to physical environment to expanded services requirements during COVID, really should consider reviewing those policies closely to ensure that changes aren't needed now with the changing tides. And CMS has released some fact sheets here (they're online on the CMS website). We're, of course, happy to talk about those as well if there are any interested stakeholders.
Leslie Thornton: Great. That's good to know, Devin.
Providers also need to be aware of state licensure requirements and waivers as well as telefraud and HIPAA (Health Insurance Portability and Accountability Act) guidance. And so, on the licensure point, even though the rules in each state varied, all states created some sort of flexibility for providers to practice medicine during the pandemic. These waivers allowed flexibility for providers to practice with out-of-state, emergency, or limited licenses. These policies are nearly all expired at this point, but with the growth of telehealth, there also has been a growth in telehealth-specific licenses, which are a type of limited license that some states have, to allow providers with valid out-of-state credentials to practice telehealth only in state. This really gives providers a more streamlined licensure process—rather than being required to obtain a fulsome medical license in the state—but still gives the state some regulatory oversight.
Devin Cohen: Yes, and the flexibility has been really helpful for providers that want to practice in other states and that reminds me of licensure compacts. With these telehealth licenses also comes a growth in popularity of licensure compacts, which are agreements between states that allow providers to submit a singular application to practice medicine in states within the compact. This similarly allows states to still retain some regulatory oversight over credentialing processes but does lessen the hoops that providers have to go through to be able to practice across state lines. Emergency declarations and state Board of Medicine statements waived some of the licensure rules and created almost de facto licensure compacts by allowing out-of-state providers to practice in the state so long as they had a valid license in another jurisdiction. Even after the expiration of these policies, it's going to be very interesting to see what impact the flexibilities have in the future given the efficiencies introduced and which ultimately increase access to care for a lot of patients.
Leslie Thornton: Yes, good points, Devin. And moving in a slightly different direction, I think it's important to touch on the HIPAA-related flexibilities that were put in place during the pandemic or during the public health emergency, specifically, and where those stand now. With the increase in telehealth and other remote-based, health-focused platforms and technologies, the pandemic introduced additional challenges for data privacy and information security. So, for example, many providers who are subject to HIPAA were providing telehealth services for the first time, using technology that may not have been vetted for HIPAA compliance and that those providers may not have been accustomed to using.
Devin Cohen: I think it was in light of this novelty that the Office for Civil Rights (OCR) really put some flexibilities in place starting in March of 2020. OCR essentially said it would exercise discretion and not impose penalties for providers using remote monitoring technology. But, in April of this year, OCR announced that discretion's ending; it instituted a 90-day transition period from May 12 to August 9 of this summer to give time for providers to get in compliance.
Leslie Thornton: Right. And so this is really another situation in which flexibility was borne out of the nature and urgency of the moment of the public health emergencies. These waivers and flexibilities were in place near the start of the pandemic, so once these expire, we'll really see where that leaves us. We have grown accustomed to these flexibilities that were introduced—much like work-from-home—and so to begin taking things away . . . most people don't react well when things they like or things that are convenient to them are taken away, particularly if they are taken without a compelling reason to do so. So, it seems to put providers and patients in a bit of a predicament here.
For HIPAA enforcement, in particular, we know that OCR has a lot on its plate right now with new guidance around online tracking technologies that is getting a lot of push back from covered entities and business associates. So, it will be interesting to see what happens here.
Devin Cohen: Yes, and [it will be interesting to see] OCR's enforcement strategy and how aggressively they seek to enforce after such a long period of discretion. It will be really important for providers, in particular, to be looking out for future guidance from OCR, keeping an ear to the ground, particularly to see if they're focusing on the similar issues as other agencies for consumer protection, such as the OIG (the Office of Inspector General for the U.S. Department of Health & Human Services) related to Medicare Advantage.
Leslie Thornton: Right. These HIPAA flexibilities and really telehealth in general was a plus for providers. On the flip side, those flexibilities can introduce opportunities for fraud. We saw it with COVID relief payments, and we also saw it with fraud in telehealth, which is often deemed "telefraud." To help reduce the risk of fraud and harm to federal health care programs and patients, the OIG issued a fraud alert in July 2022 which encouraged providers to stay vigilant when contracting with companies that offer certain telemedicine or telehealth services. And these companies may claim to provide telehealth services but, in actuality, are really perpetuating fraud schemes by paying illegal kickbacks to practitioners and submitting fraud claims to government health care programs.
Devin Cohen: So, what did the OIG say providers should look out for?
Leslie Thornton: The OIG identified certain "suspect characteristics" that providers should look out for when working with telemedicine companies, and this includes things that deviate from normal practice and are more likely to come up in the telehealth context. For example:
- if recruitment occurs only through the Internet or social media platforms;
- if the practitioner doesn't have sufficient contact with the patient to assess the medical necessity of services being provided or there is a lack of follow-up with patients;
- if compensation is based on the volume of services ordered; or
- if there are suspicious billing practices with federal payors, including if the company only provides services to federal health care program beneficiaries but does not accept insurance from other types of payors.
Devin Cohen: Got it. Even though we are coming out of the public health emergency, telehealth is here to stay, so these will be really important considerations for providers really when contracting particularly with their services providers—from a telehealth perspective, their suppliers.
Leslie Thornton: Right, and of course, the pandemic had effects outside of just the clinical setting. Though in-person, conventional clinical trials slowed at the start of the pandemic, there was a boom in decentralized trials that are able to use various digital technologies, like telehealth, wearables, and other remote monitoring devices.
Devin Cohen: This is an area we talk about often and I know, work in often, and have been watching closely. Decentralized trials grew exponentially during the pandemic. It forced researchers and study sites to find creative ways to keep their studies moving forward where possible despite pandemic-related restrictions while also keeping research participants safe. And the extension of a lot of the waivers in the Consolidated Appropriations Act makes decentralized trials easier, too.
We haven't even touched on FDORA (the Food and Drug Omnibus Reform Act of 2022), which was folded in as part of the Consolidated Appropriations Act. FDORA requires the Secretary of Health & Human Services (HHS) to issue guidance clarifying the use of decentralized clinical trials by the end of this year (December 29, 2023). This should address some areas of historical concern like digital health technology, subject recruitment, remote data collection, and other various hot topics that we're continuing to discuss today.
Leslie Thornton: And in guidance released in May of this year, FDA acknowledged that decentralized clinical trials may enhance convenience for clinical trial participants, reduce burdens placed on caregivers, expand trial access to more diverse populations, impose certain efficiencies on trials, and even facilitate research on rare diseases as well as diseases affecting populations with limited mobility. So, it's clear from these statements that certain federal agencies—at least the FDA—do see the benefits of decentralized trials.
Devin Cohen: I think that fits great here with the overall theme—that the public health emergency, as May came and went, it's hard to see a world where backtracking on the pandemic-era flexibilities and rules will be particularly aggressive and heavy-handed in an immediate sense. That's particularly true when those kinds of flexibilities did enable on-the-ground treatment during moratoriums of care.
Leslie Thornton: Right, and public attention on these topics only continues to grow as we know. This spring, the DEA (Drug Enforcement Agency) received over 38,000 comments on their proposed rules for permanent telehealth flexibilities. They responded by posting a notice on their website, explaining that current flexibilities will be extended as they "work to find a way forward to give Americans the access that they want but with appropriate safeguards."
And so, to backtrack a little bit and examine these DEA flexibilities, providers have been permitted to prescribe some controlled substances via telehealth without an initial in-person visit. The DEA also waived the requirement that providers obtain a DEA registration in the state where the patient is located, so long as the provider can prescribe medication in both the state in which they are registered and the state in which the patient is located.
Devin Cohen: Right, a lot of added flexibility and room there to facilitate remote prescribing. So, it's not surprising that people have a lot to say about these rules and that there should be a more permanent solution moving forward.
But, as you alluded to earlier, DEA issued a temporary rule to allow both DEA and HHS to review nearly 40,000 comments and come up with a more permanent solution. So, the temporary rule allows patients and practitioners to continue to utilize these flexibilities that they really depended on for the last few years but also extends those through November 11 of this year. And, if a patient and provider have an established telemedicine relationship prior to November 11, the options and flexibilities remain in effect through November of next year.
Leslie Thornton: In line with the other topics that we've touched on so far, though it's hard to say exactly what will stick and what will get rolled back, we do expect a lot of these flexibilities to continue. In the summary of their temporary rule, DEA and HHS stated that the final set of regulations will permit the practice of telemedicine "under circumstances that are consistent with public health."
Devin Cohen: The Substance Abuse and Mental Health Services Administration, they weighed in on this remote prescribing as well, right?
Leslie Thornton: They did. So, while COVID has grabbed the spotlight the last couple of years, opioid use really remains a massive problem, and, unfortunately, there are data suggesting the problem only got worse during the pandemic as many people were isolated from their families and support systems, may have lost their jobs, or experienced other traumatic events. And so, SAMHSA (as you said, the Substance and Mental Health Services Administration) created flexibilities around opioid treatment programs (OTPs) during the public health emergency.
For example, SAMHSA exempted OTPs from the requirement of performing in-person physical evaluations for any person or any patient who will be treated with buprenorphine, if a physician determines that telehealth provides an adequate means for evaluation. This flexibility has been extended through May of next year, and SAMHSA also has proposed making this permanent.
Also, in March of 2020—so going back a little further to the beginning of the pandemic—SAMHSA allowed states to issue exceptions for patients in an OTP to receive up to either 14 or 28 days of take-home medication, depending on their stability. This particular practice has had really positive feedback and with very few drawbacks or reported incidents from its use. And in April of this year, SAMHSA issued new guidance revising the OTP methadone standards for unsupervised use, extending the practice of at-home, unsupervised doses. This guidance is effective through May of next year, one year from the end of the public health emergency, or until HHS publishes a new final rule, whichever comes first.
Devin Cohen: It sounds like DEA, HHS, and SAMHSA are all really taking time to think about this, and it's helpful to be thoughtful with consideration of how impactful all of these options we've become used to have been the last several years.
Leslie Thornton: That's right. With that mindset, Devin, if you could just recap hospital-at-home—and really, what were the impacts of COVID and where do things stand today with hospital-at-home?
Devin Cohen: Of course, and this is another thing that we have been monitoring closely, so I'll start with just a little bit of background.
There's been a huge growth in the hospital-at-home program—programs that existed before COVID but really boomed in response to nationwide shortages and shutdowns. According to one report, the hospital-at-home market is projected to grow 50% from $200 billion to $300 billion by 2028, so it's not a surprise that so many companies are trying to get in the space. The hospital-at-home program model relies on an underlying licensed acute care hospital, subject to Medicare Conditions of Participation, to oversee and accept responsibility for at-home programs, with escalation of care, if necessary. Naturally, at-home care varies greatly from hospital care, so these programs are designed to embrace options that are needed to accommodate differences in at-home environments.
We really saw this more recently in December of 2022 when CMS and HHS extended the Acute Hospital Care at Home Program, a federal waiver program that was designed to address the health care needs of homebound populations. Those flexibilities under the Consolidated Appropriations Act, in practice, are very strongly supported through the end of 2024. An important aspect of this model, though, to really think through is the billing structure and how everyone is paid. Hospital-at-home is currently paid by diagnosis-related group (DRG) rates and is historically tied to hospital services, which is not terribly surprising. While DRG reimbursement provides predictability and some level of administrative ease, successful programs are more likely to reward high-quality care by tying payments to reductions in follow-up care, re-admission, and more. In this way, the hospital-at-home program is ripe for bundled payments, episodic payments, or other alternative payment models which tie payment to a more wholistic patient care experience. The typical "per-click" DRG reimbursement model is really cumbersome in this setting. Now, a number of payment mechanisms that have been tested by the Center for Medicare and Medicaid Innovation (or known as the "Innovation Center") with mixed results, those would be well suited for hospital-at-home programs, or may be, but the Innovation Center has not really shown interest in a program exclusively focused on use of alternative payment methodologies in hospital-at-home at this time.
That was a lot of information to digest, but this is a program that's going to continue to grow, and the influences and developments related to the Consolidated Appropriations Act, state licensure for clinicians, and DEA prescribing are going to be particularly relevant and intertwined.
Leslie Thornton: Great. A lot of information, but a lot of helpful information, Devin—thank you. So, it seems like providers and payors have a lot to navigate, and a lot of competing requirements and risks here. But, there also seems to be strong momentum among hospitals, home care agencies, payors, and patients to make these programs permanent, so it may be another silver lining of the pandemic, perhaps.
Devin Cohen: Yes, it definitely is. We'll be living with a lot of these flexibilities at least through the end of next year, but from there, we're going to have to get creative in driving down costs and ensuring that there are adequate safeguards to ensure compliance with evolving guidance from OCR, CMS, HHS, DEA, SAMHSA, and you name the next regulatory body—because there will be another.
Leslie Thornton: Thank you so much, Devin, for talking with me about these important topics. For those of you listening who would like more information on the topics discussed today during this podcast or our health care group more broadly, please don't hesitate to contact myself or Devin. You can also subscribe and listen to other Ropes & Gray podcasts wherever you regularly listen to your podcasts, including on Apple, Google, and Spotify. Thanks again for listening.
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