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COVID-19: Beyond Tomorrow
May 18, 2020

Implications for Telehealth in a Postpandemic Future: Regulatory and Privacy Issues

Author Affiliations
  • 1Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Cambridge, Massachusetts
  • 2Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire
JAMA. 2020;323(23):2375-2376. doi:10.1001/jama.2020.7943

The coronavirus disease 2019 (COVID-19) pandemic has required health care systems to radically and rapidly rethink the delivery of care. One of the most remarkable ongoing changes has been the unprecedented accelerated expansion of telehealth. The pandemic may provide the incentive needed to realize the potential of telehealth. Nevertheless, concerns remain that safety and privacy may be compromised by rapid deregulation, despite data, although limited, regarding good overall quality.1 In studies conducted before the COVID-19 pandemic, patients reported high levels of satisfaction.2

This Viewpoint describes some of the most important telehealth regulatory changes that have occurred in response to COVID-19 and discusses some of the opportunities and challenges inherent in successfully harnessing the unexpected expanded role recently given to telehealth in the US.

Changes in Payment

One of the most significant changes for telehealth related to the COVID-19 pandemic has been payment parity between telehealth and in clinic care. Previously, many states required insurers to cover telehealth but did not stipulate payment parity.3 Low reimbursement for telehealth was viewed as a critical disincentive. Without payment, it would be difficult for clinicians to afford to provide the service, despite data from previous studies suggesting clinicians were broadly supportive about its use.4 At the same time, payment rates should reflect the cost of the service, avoiding overpayment if clinicians can use telehealth to deliver more visits per session. The concept of payment equity is emerging so as to avoid perversely incentivizing the use of telehealth encounters.

Recognizing the need for incentives, some private payers and Medicaid programs announced payment parity for telehealth for the duration of the pandemic.5 For instance, for a routine primary care visit, such as for a 20- to 30-minute visit with a physician, Louisiana Medicaid reimbursement for 2020 would be $33.95 for a telehealth visit (Current Procedural Terminology [CPT] code 99443), compared with $62.65 for a physical visit (CPT code 99214). This payment parity is a necessary step, as there has been a substantial shift in some clinics, increasing the proportion of telehealth visits from 10% before the pandemic to more than 90% telehealth work during the pandemic.6 Regulatory change governing payment parity will need to be sustained after the pandemic, and adequate reimbursement for telehealth will be an important factor to maintaining broad adoption. Without these changes in reimbursement, some small practices, especially in rural areas, may encounter financial difficulty because of reductions in physical clinical visits.

Payment also remains a problem at state boundaries, because in many cases, billing is not approved across states. Cross-state billing remains a significant barrier for clinicians who are not part of an in-state health care network.

Changes in Privacy

Patient privacy regulations, especially the Health Insurance Portability and Accountability Act of 1996 (HIPAA), also has been perceived as a potential barrier to a wider adoption of telehealth. Given the importance of secure and private channels of communication, some clinicians may be challenged in finding telehealth technology partners willing to sign business associate agreements given the prepandemic requirements for security and privacy.

In response to the pandemic, the Office for Civil Rights at the Department of Health and Human Services issued a notice of enforcement discretion, stating that it will not impose penalties for HIPAA violations that occur during the good faith provision of telehealth during the COVID-19 emergency.7 This allows clinicians and health care entities to use platforms that are not HIPAA compliant, such as Facetime and other commonly used channels. This practical approach was needed to increase telehealth services quickly but will require careful consideration of the long-term issues with these platforms.

However, a more nuanced approach to privacy may be needed after the pandemic to support telehealth expansion. Privacy concerns should not interfere with the actual need of patients to receive care on a timely basis. HIPAA regulations may need to be revisited, so patients could be given the responsibility and ability to share their health information with clinicians who require that information. While the risk for privacy intrusions under the pandemic standards, such as “Zoom bombing”—which is when disruptive, uninvited users force their way into a virtual meeting—needs to be acknowledged, privacy may not be the most important concern during a crisis. However, when the pandemic begins to resolve and for situations in which the need for care is not urgent, due diligence is necessary to ensure that privacy is addressed appropriately. Guardrails, such as periodic audits, would be needed to ensure security. Perhaps, similar to systems in the financial sectors (ie, personal access to bank accounts and investment accounts), a more user-friendly approach to privacy may be possible for personal health care delivery.

Changes in Licensing

Telehealth also has been limited by geographic rules that govern medical licensing. Previously, some states, such as Ohio, New Mexico, and Texas, created special telehealth licenses and other states, such as Arizona, Tennessee, and Vermont, entered into the Interstate Medical Licensing Compact to enable out-of-state physicians to practice in their jurisdictions via telehealth.3

In response to COVID-19, some states are relaxing or eliminating certain licensure requirements. This trend has enabled some clinicians from one state to care for patients in a different state. Because these regulations create a more permissive environment, however, mechanisms are required to ensure verification of clinicians. For instance, as in the insurance and finance industries, recorded calls could be used to audit and monitor the quality of care (which some platforms have already incorporated),8 although provisions to guarantee patient privacy and confidentiality would need to be established. Another approach may involve federal telehealth practitioner licensing, which could reduce the compliance burden for physicians who practice telehealth in more than 1 state.

What Next?

To maintain the impetus for change and the momentum for telehealth services that have resulted from the COVID-19 pandemic, the US cannot revert to prepandemic telehealth regulations. Neither can the US simply adopt the recent changes, because they lack nuance to support clinicians while ensuring safety and privacy for patients: a third regulatory path is needed.

First is the issue of safety. Is the health professional on the video conference call qualified and competent? The current economy has found ways to qualify and certify the services provided by delivery drivers and online portals, but those methods are not foolproof. Quality evaluation must be built into the telehealth process. Quality evaluation remains a challenging priority to accomplish, even in the context of traditional visits, and it will be no less difficult for telehealth visits.

Second is the trade-off between privacy and ease of use. Here the principles of “value architecture” can be helpful. Does all telehealth have to be embedded in current organizational electronic health care record (EHR) systems to satisfy privacy regulations? This choice results in a system in which the only access to information is via cumbersome EHR systems. Imposing such a requirement might lead to balkanization of the information that patients and clinicians need to prevent error, waste, and duplication. What if instead, patients’ health care data were stored in secure databases that allow immediate need-to-know access to past history, test results, and current medication? Lessons from relaxing HIPAA during the COVID-19 pandemic may be helpful to reconsider patient data governance.

Third are issues of access. Patients cannot realize the benefits of telehealth if physicians are not incentivized to maintain telehealth practices after COVID-19. A shift away from a geographic emphasis on licensure and restrictive networks also could facilitate more telehealth. But regulatory corrections are not as easy as they seem at first glance. Payment parity may not be realized after the pandemic, in part because telehealth visits are generally shorter than in-office visits and forgo procedures, leading to a reduction in revenue under fee-for-service. Telehealth might be a more economic way to deliver health care, but that may represent an important financial threat to practices and centers with traditional delivery structures such as fee-for-service or to those with significant capital investments in existing facilities.

Fourth is a more sophisticated approach to payment. Payment parity has been broadly implemented during the pandemic and makes the provision of telehealth financially more attractive to providers. Moving forward, however, payment equity rather than parity should be the goal. Telehealth visits tend to be shorter and include fewer diagnostic services than in-person visits. Reimbursing at identical rates as in-person visits thus would represent overpayment. The principle of equity would suggest that reimbursement rates for telehealth services should be close, but not identical to, reimbursement rates for in-person visits. Mandating payment equity and determining the optimal differential between reimbursement rates for virtual and in-person visits will require more study and careful consideration.

To ensure that the increased utilization of telehealth observed during the COVID-19 pandemic is not squandered, lessons from this period of deregulation need to be thoughtfully extracted. Some modifications, such as waiving parts of HIPAA, are clearly intended for a crisis but can suggest areas in which sustained regulatory change could be beneficial. Other modifications, such as payment equity rather than parity, should be considered but raise further questions about implementation.

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Article Information

Corresponding Author: Carmel Shachar, JD, MPH, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, 23 Everett St, Cambridge, MA 02138 (cshachar@law.harvard.edu).

Published Online: May 18, 2020. doi:10.1001/jama.2020.7943

Conflict of Interest Disclosures: Ms Shachar reported receiving a grant from the Collaborative Research Program for Biomedical Innovation Law, a scientifically independent collaborative research program supported by a Novo Nordisk Foundation grant (NNF17SA0027784). Dr Elwyn reported receiving active research grants from the Patient-Centered Outcomes Research Institute, Robert Wood Johnson Foundation, and Cystic Fibrosis Foundation and advising for EBSCO Health, PatientWisdom, Abridge AI, and Bind Insurance.

Additional Contributions: Some of the concepts and ideas incorporated in the article were based on discussion and interviews with Sanjeev Arora, MD, ECHO Institute; Elliot Fisher, MD, MPH, Dartmouth Institute for Health Policy and Clinical Practice; Matthew Handley, MD, Kaiser Permanente of Washington; Judd Hollander, MD, Sidney Kimmel Medical College at Thomas Jefferson University; Surena Matin, MD, MD Anderson Cancer Center; Lois Ramondetta, MD, MD Anderson Cancer Center; Robert Satcher, MD, PhD, MD Anderson Cancer Center; and Rahul Sharma, MD, MBA, New York Presbyterian–Weill Cornell Medical Center. None of these individuals were compensated for their participation.

References
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Noel  K, Messina  C, Hou  W, Schoenfeld  E, Kelly  G.  Tele-Transitions of Care (TTOC).   BMC Fam Pract. 2020;21(1):27. doi:10.1186/s12875-020-1094-5PubMedGoogle ScholarCrossref
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Kruse  CS, Krowski  N, Rodriguez  B, Tran  L, Vela  J, Brooks  M.  Telehealth and patient satisfaction.   BMJ Open. 2017;7(8):e016242.PubMedGoogle Scholar
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State Telehealth Laws and Reimbursement Policies Report. Center for Connected Health Policy. Published 2020. Accessed April 12, 2020. https://www.cchpca.org/telehealth-policy/state-telehealth-laws-and-reimbursement-policies-report
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Henry  BW, Block  DE, Ciesla  JR, McGowan  BA, Vozenilek  JA.  Clinician behaviors in telehealth care delivery.   Adv Health Sci Educ Theory Pract. 2017;22(4):869-888. doi:10.1007/s10459-016-9717-2PubMedGoogle ScholarCrossref
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COVID-19 telehealth coverage policies. Center for Connected Health Policy. Published 2020. Accessed April 12, 2020. https://www.cchpca.org/resources/covid-19-telehealth-coverage-policies
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Lonergan  PE, Washington  SL  III, Branagan  L,  et al. Rapid utilization of telehealth in a comprehensive cancer center as a response to COVID-19. Health Informatics. Published online April 15, 2020. doi:10.1101/2020.04.10.20061259
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Office for Civil Rights (OCR). Notification of enforcement discretion for telehealth. HHS.gov. Published March 30, 2020. Accessed April 12, 2020. https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html
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Telehealth after visit summaries. Abridge for Clinicians. Accessed April 15, 2020. https://www.abridge.com/clinicians
7 Comments for this article
EXPAND ALL
Telemedicine is Not Good Medicine
Bruce Russell, MD | Solo Practice
I genuinely hope that telemedicine does not expand greatly after the covid crisis is over. I've dealt with the overuse of antibiotics by the night time teledocs for several years, but there weren't that many visits. Now patients are all in on the convenience of telemedicine. It is not, however, a good way to practice medicine. It is being used far too often now because it is the best thing that we have. When practice returns to a more normal footing, the vast majority of these visits should be in the office. I fear that convenience and money savings by the insurance companies will trump the benefit of a patient being seen and evaluated. In the office they are seen not just for their UTI, sore throat, or blood pressure medicine refill, but also for all of the health screening issues.

My fear is that it will be a free for all and patients will never talk to the same doc twice, much less to a real primary care doc. It will lead to further fragmentation of medical care, which we all know is inferior medical care. Soon there will be call centers and corporate health groups that will lobby not only for out-of-state doctors to be licensed, but also out-of-country docs. Oh the humanity.
CONFLICT OF INTEREST: None Reported
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Value of Telehealth
Kenneth Dandurand, R.Ph.,MS | MedNovations
While I agree with most of the points outlined in the report there appears to be an underappreciation of the impact of telehealth. The authors state that payment equity suggests that telehealth should be reimbursed at a lower rate because less time is spent and fewer diagnostics are performed. However the more important measure would be outcomes, especially since there is ample evidence that more unnecessary diagnostics are performed when patients are seen in the office. If patients can get sooner appointments, less waiting in a crowed office exposed to contagions, and better outcomes, then that should be the payment measure.
CONFLICT OF INTEREST: Co-Founder Telepharmacy Company
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Time for Parity with Physical visit and Liability Reform-Nationally
Hunasikatti Mahadevappa, MD FCCP | Fairfax Hospital, Falls Church, VA and FDA, Silver Spring,MD
The authors state that 'the concept of payment equity is emerging so as to avoid perversely incentivizing the use of telehealth encounters'. Physicians spend the same or more time to come to a reasonable management plan in telehealth as in real life visits; they do not spend more than 3-5 minutes doing physical examinations in a routine office visit. It is time for teleheath to get paid the same as a physical visit. We can obtain vital signs through an FDA-approved remote monitoring unit which can be sent to the patient by mail, avoiding contact with other patients in waiting areas. 

The authors state that "telehealth also has been limited by geographic rules that govern medical licensing." This can easily be resolved with a Congressional act approving a National Medical License. Many states like Texas have waiting times of more than a year to get a license. Similar to the Veterans Hospital Administration system, any state license should be OK to practice medicine nationally.

Health and Human Services has issued a notice of enforcement discretion, stating that it will not impose penalties for HIPAA violations that occur during the good faith provision of telehealth during the COVID-19 emergency. Litigious behavior has destroyed countless lives of dedicated physicians and has impacted patient access to care. It is time for the congress to enact national liability reform protecting physicians from unnecessary lawsuits as long as they follow professional society guidelines. This may also may help in unnecessary tests which are being done in about 25 % of the time.

However telehealth cannot always be a substitute for physical visits. It may be used when elderly patients are not able to visit physicians' settings due to frailty and transportation barriers. This option should be available for these patients even after the current pandemic is over. The same reimbursement should be extended to physicians working at nursing homes and assisted living facilities. Let the patients decide if they like to visit the physician virtually or old-fashioned way.

The Views expressed here are my personal opinions should not be construed as that of agency.





































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CONFLICT OF INTEREST: None Reported
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Telehealth Improves Access to Care
Oliver Jones, MD | MFM Group Practice
I am a Maternal-Fetal Medicine specialist in Denver. As part of my practice I provide prenatal diagnosis services to rural parts of Colorado, Wyoming and Nebraska. Prior to COVID-19 I traveled to these locations to see patients (expensive in time and money) or patients had to travel to Denver to my office (equal expense to them). The ability to do realtime ultrasound examination remotely along with a face-face discussion has made for a more efficient use of patient time with good quality of care and high patient satisfaction. Personally, I prefer an in-person office visit for my patients. But given the geographic challenges in my area, telehealth is a great option. I plan to continue with telehealth as part of my practice and will expand it to meet the demand of these locations.

I agree that the idea of individual state licensure is outdated. A national license can be implemented with appropriate physician oversight. I would happily pay a higher fee to avoid the redundant process of applying for and maintaining multiple licenses as I do now.
CONFLICT OF INTEREST: None Reported
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Telemedicine Parity and Privacy
Michael Plunkett, MD MBA | Practice
Parity: reimburse them the same for 1 year. Let the patients and physicians make the call (pun intended). I think you’ll find the two parties coming to a very satisfactory equilibrium. And I think you’ll see telemedicine becoming a large part of everyday health care with both patients and physicians embracing it.

Privacy: Forget about it. I’m still waiting for my first patient to be saved by HIPPA. On the contrary, all I see is obstacles to getting to find out what’s wrong with the patient. The Good Book says “ye shall know the truth, and the
truth will make you free.” Or per Marcus Aurelius, I know in no way in which any man has been harmed by the truth.”

Let’s continue the present good faith relaxing of HIPPA for a year or 3 and let the NIH report that “really, we can’t find any difference.” If they find proof of its wonderment, then so be it.
CONFLICT OF INTEREST: None Reported
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Role of Telehealth
Juby George-Vaze, RN, CCM, MBA | Globex Health, CEO and Chief Innovation Officer
I agree with the spirit of the article, especially the changes in payment and waiving of certain regulations that were major barriers for adoption of telehealth. "Social distancing, stay at home" orders created a perfect "storm" for the massive adoption of telehealth that took place since mid-March. Prior to CoVID, the average telehealth visit was 7-12 min with a few minutes for documentation that was reimbursed in the $45-$120 range. During CoVID with the massive add-on of new codes that are allowed during telehealth, the opportunity for that one visit E/M to have an increase of 30-200% additional reimbursement is there, if captured properly.

These additional reimbursements will vary by payer due to commercial insurances being regulated by each State Department of Insurance where they are licensed. On March 20, CMS granted additional waivers that became retroactively effective starting March 1st; you can technically resubmit claims from televisits from March 1st onwards to reflect the new changes. AAPC's website offers a good summary. https://www.aapc.com/blog/50523-medicare-telehealth-coding-as-of-april-30/ of the main announcement.

CMS is considering keeping these expansions since overall they are looking to reduce cost and improve care for chronic conditions and the elderly (which cost the most to our healthcare system) who are better off at home. Telehealth reduces barriers to care such as long wait times, delays in appointments, commutes, taking time off from work to get to an appointment or caregiver burden of getting patients to their appointments. People like it, and to manage the "consumerism" shift, every brick and mortar practice will need to add a digital health service to their practice, offering maybe weekly scheduled telehours with each provider.

Expanding telehealth requires payment parity, meaning specialists, social workers, case managers, nutritionists, PT, OT, and speech therapists all get paid at the rates they're accustomed to. Having been part of the original Value-Based payment model that help enable the initial 2 televisit reimbursement codes by commercial insurance in 2014-2015, "cost containment", quality, and outcome are the inherent result if telehealth and remote health monitoring and other digital health tools are allowed to prosper

Insights from NYC Telehealth Leaders may be of interest: https://www.youtube.com/watch?v=1FhoQy1miuM&t=4s
CONFLICT OF INTEREST: None Reported
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Telehealth - More than Meets the Eye
Danielle Weiss, MD | Private Practice
As a physician I take great umbrage at the notion that telehealth visits are shorter and include fewer diagnostic codes and thus reimbursement identical to that for an office visit would be overpayment. In actuality these visits are often longer and cover the same level of detail in medical care. Treating these visits as anything less than an in-person office visit is an insult to the physician's time spent, expertise, and quality care given. In addition, for many patients telehealth visits reduce their transit time, stress, and risk,  all things that add to improved health.
CONFLICT OF INTEREST: None Reported
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