Telemedicine
COVID-19 and Cross-State Clinician Licensure: Federal and State Regulations, Revisited, and What To Do About Them
The COVID-19 pandemic has dramatically increased the number of patients and providers seeking to implement and use telehealth visits and other digital health solutions – and rapidly, at that. The challenge of implementing digital health solutions, particularly telehealth, has historically been the patchwork setup of both federal and various state regulations that made it difficult for providers and telehealth vendors to offer solutions at a large scale, particularly across state lines. In the current state of public emergency, both the federal government and various state governments are recognizing the need to ease prior restrictions and expand telehealth availability in order to help patients receive care at home; this helps limit the spread of COVID-19 by further enabling social distancing and freeing up providers’ brick-and-mortar hospitals and clinics to treat COVID-19 patients. The need is clear, as is the desire by all parties to jump in and offer telehealth visits. The new challenge has become understanding how state requirements fit in daily updates to federal law. In this blog post, we will look first to the current legal environment with respect to the federal waiver and state regulations, and then provide recommendations (in numbered list below) as to what this means for your plans to offer telehealth visits. Specifically, clinical licensure has traditionally been amongst the most challenging regulations to contend with in offering telehealth visits. Federal reimbursement and state clinician licensure rules generally restrict clinicians from offering telehealth services to a patient physically located in a state without the appropriate medical license in that state. Now, however, through CMS 1135 waivers and state-specific executive orders, which we have described more below, clinicians are able to leverage relaxed cross-state reimbursement and licensure rules to offer telehealth services more easily and immediately during this time of public health emergency. Historically, the general rule, with few exceptions, is that a clinician must be licensed to practice in the state in which the patient receiving telehealth services is located. These rules are derived from state professional licensing laws, as well as from payor requirements, including the conditions of payment under the Medicare and Medicaid programs. Therefore, a physician licensed to practice in Minnesota, for example, could not typically provide telehealth services to a patient located in Iowa during the time of the visit without first obtaining an Iowa license to practice medicine. Failure to do so could subject the physician’s medical license to discipline, and could also render the services not billable to various private and governmental payors. Currently, the in-state licensure requirements of payors and professional licensing bodies are beginning to change within the confines of the COVID-19 public health emergency. With respect to Medicare and Medicaid billing requirements, under the emergency proclamation by the President, CMS has the authority to issue “1135 waivers” that will temporarily waive or modify certain Medicare and Medicaid requirements to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in Federal health care programs. Shortly following the Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak, both HHS and CMS issued statements announcing a number of COVID-19 1135 waivers now either applicable automatically nationwide or available through request by individual providers and the states, depending on the type of waiver. These waivers encompass an array of options and relaxing of rules that apply to services provided to Medicare and Medicaid patients. One of the waivers provides that CMS will “temporarily waive [reimbursement] requirements that out-of-state providers be licensed in the state where they are providing services when they are licensed in another state” (the “Clinician Licensing Waiver”). (Other waivers ease restrictions surrounding provider Medicare and Medicaid enrollment, skilled nursing and other long-term care facility requirements, and bed allocation requirements). This is an enormous and important shift, and one that digital health advocates have been championing for a long time, as it enables clinicians to “see” patients in other states without a protracted cross-state licensure process. The challenge, however, is understanding how the federal waivers and existing state requirements interact. These 1135 waivers apply only to federal requirements, and any providers looking to practice in accordance with these waivers must be careful to also comply with applicable state laws. Largely, the COVID-19 1135 waivers fall in two categories: (1) blanket waivers; and (2) case-by-case waivers. The blanket waivers include those waivers listed by CMS in their statement and are applicable automatically nationwide with respect to Medicare rules (not Medicaid or other CMS programs, except by request, as noted below). The Clinician Licensing Waiver is one such waiver. This waiver applies automatically to Medicare reimbursement, but clinicians must also ensure they are practicing in accordance with a particular state’s licensing rules before issuing professional services in that state. States that would like these Medicare blanket waivers, including the Clinician Licensing Waiver, to apply to their state’s Medicaid program must send a request to CMS for case-by-case approval. Currently, only Florida and Washington have received approval for their requested COVID-19 1135 waivers, including the Clinician Licensing Waiver along with other provider enrollment and prior authorization requirement waivers. However, CMS states that it will continue to expeditiously review and approve 1135 waivers during the COVID-19 public health emergency. This CMS website will provide up-to-date information on all states that receive any COVID-19 1135 waivers. While the Clinician Licensing Waiver is limited in applicability to Medicare and Medicaid reimbursement, states are beginning to follow suit by temporarily waiving their state level professional licensure requirements for telehealth providers. Still, providers should take caution to not provide services without a state license unless and until it is confirmed that the state will allow this practice. One state that we have identified as permitting telehealth practice without a state license during the COVID-19 public health emergency is Iowa. Iowa’s emergency proclamation contains a section that temporarily suspends various telehealth practice standards, including the requirement that Iowa telehealth providers be licensed in Iowa. Note, however, that commercial payor rules may be unaffected by both the federal waivers and the easing of state professional licensing rules. From an operational standpoint, the Clinician Licensing Waiver ostensibly eases offering telehealth visits across state lines, but the state-specific regulations still require ongoing vigilance. For those providers and other types of vendors seeking to offer telehealth, we would encourage the following: Identify exactly which populations you must be able to treat in order for the telehealth visits to be feasible and viable (financially and operationally) for your organization While organizations would like to be able to immediately offer telehealth visits for everyone, the reality at this time, while states sort out whether they will ease state licensure restrictions, is that you may only be able to conduct telehealth visits and receive reimbursement in states in which your clinician is allowed to practice without a license and for certain populations only. It will vary tremendously by state, and the answer may change on a near-daily basis, as states make their decisions. Speak with your attorney about the states in which you want to offer visits (or where your patient populations may currently be) to understand the current status for those states Per above, the situation is changing rapidly, and we strongly recommend asking your attorney to check the state’s status vis-à-vis the federal waivers. We would advise adding that into your tracking document (see next item). Draft your quick state-by-state plan and what your readiness checks will be to start with a new state (and do not worry – this can be rough-and-ready) We often help our clients with state rollout plans and readiness checklists, and they are still important now; however, given the dramatic need for speed, do not let the perfect be the enemy of the good. Based on your answers to the above two items, you should confirm with your team both the plan for which states you will be able to offer visits in and also the criteria for when and how you will assess and identify the next states in which you can offer telehealth services. You can perfect and polish these plans at a later point, but having a plan of action for all involved will prevent confusion or, worse, lack of compliance if you do not pay careful attention to states’ evolving rules. We would recommend that your state readiness checklist include an attorney approval step; this is particularly important now, since the states’ rules are changing so rapidly. The good news is that, for the most part, the changes are leaning toward the more permissive rather than restrictive, so you may find new states in which you are able to operate. Identify exactly which active state licenses your clinicians hold and document, ideally in a spreadsheet or other easy tracking mechanism We recommend (and create for our clients) tracking tools with respect to clinical licensure during regular times, and it is equally important now. While the goal is to be able to offer telehealth visits to patients in states in which your clinicians are not currently licensed, you will need to keep track of who is actually licensed where, so that if and when regulations should revert, or if and when there should be changes to the scope of licensure or reimbursement, you are able to quickly assess your own staff’s licensure status and pivot as needed. These tracking tools need not be fancy, though it is helpful to tie them to calendar reminders or other ticklers to enable consistent monitoring. Keep in mind – and regularly monitor – other relevant requirements as you contemplate the nature and process of the telehealth visits. For example, you will still want to abide by current HIPAA requirements (which are also changing during this public emergency – please see our article here), documentation requirements, and reimbursement-related considerations. Your standard operating procedure and telehealth visit process will likely need to be altered to include verbal caveats or discussion points between your providers and the patients. We would advise reviewing and then either drafting or updating your current visit script, as well as the documentation presented on your website portal for the telehealth visit. Your plan for downtime procedures is going to become all the more important – assess if you’re ready and that your providers are aware of what to do. With so many people using internet and particularly video chat services, our IT infrastructure and that of the telehealth platform vendors themselves is experiencing a surge in usage, which will test capacity levels. This would be the case in “regular” life, but becomes more important now, as you reach out to and conduct telehealth visits with new patients: does your script and posted information include information as to how the patient can reach you if the telehealth visit is interrupted? What should be their plan with respect to reaching out to local (in-state) providers versus your organization, both for downtime and post-visit? This issue is rapidly changing and being updated at both the Federal and state level on a day-to-day basis. For additional information on various COVID-19 responses, guidance and resources, please see our articles on Medicare payment for telehealth services; HIPAA provisions now allowing the use of personal devices and everyday communication technology to deliver telehealth; DEA prescribing laws now allowing controlled substances to be prescribed via telehealth without an in person exam; and numerous other helpful legal analyses and guidance on COVID-19 related matters. If you would like specific information on how your state is currently treating these issues, please reach out to the authors or your usual Dorsey attorney or Dorsey Health Strategies business consultant.
March 20, 2020
by Ross C. D'Emanuele, Randall Hanson, and Shira Hauschen
Telemedicine
Medicare Telehealth Payment Expanded to Help Address the COVID-19 Public Health Emergency
On March 17, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Department of Health and Human Services Office of the Inspector General (“OIG”) each issued policy statements which expand access to telehealth services for Medicare beneficiaries and permit physicians and other practitioners to reduce or waive beneficiary cost-sharing obligations for Medicare telehealth services during the COVID-19 public health emergency. Immediately following the enactment of the Coronavirus Preparedness and Response Supplemental Appropriations Act, available here, CMS issued a temporary expansion of the Medicare telehealth benefit beginning as of March 6, 2020 and effective until the public health emergency declared by the Secretary of the Department of Health and Human Services ends. The CMS policy statement can be found here. A key element of this telehealth expansion is that payment will be made for office visits and other covered Medicare telehealth services furnished to beneficiaries located in any part of the U.S. Moreover, the CMS waiver facilitates payment for telehealth services furnished while the beneficiary is located in their home or in any care setting. Without this emergency expansion, current Medicare rules at Social Security Act § 1834(m) generally limit coverage for telehealth services to beneficiaries located in rural areas, and only when the beneficiary is within a hospital, clinic, or other medical facility at the time of the telehealth visit. Clinicians who may offer telehealth services to Medicare beneficiaries include physicians, nurse practitioners, physician assistants, clinical social workers, clinical psychologists, and registered dieticians. CMS also states that to the extent Medicare reimbursement for a telehealth service requires a prior relationship between the clinician and beneficiary, CMS will use its enforcement discretion and not audit claims submitted during the public health emergency to determine if such a prior relationship existed. The CMS waiver explicitly permits clinicians to use telephones with audio and video capabilities to furnish Medicare telehealth services during the COVID-19 public health emergency. Together with the new waiver of certain HIPAA privacy rules (addressed in our prior blog post found here), this now will permit clinicians to conduct visits with Medicare beneficiaries using common communications tools such as personal phones, devices and computers, and common technologies such as FaceTime or Skype. CMS issued a FAQ document on this temporary and emergency telehealth benefit expansion, which can be found here. In tandem with CMS’ expansion of the Medicare telehealth benefit, the OIG issued a policy statement to address the potential anti-kickback and beneficiary inducement issues that providers may face during this emergency. OIG states that it will not sanction physicians or other practitioners for reducing or waiving cost-sharing obligations that a beneficiary may owe for telehealth services furnished during the COVID-19 public health emergency and furnished in accordance with the then-applicable Medicare rules (which would include the CMS telehealth benefit expansion during the emergency). Normally, the routine reduction or waiver of Medicare beneficiary cost-sharing obligations would implicate the federal anti-kickback statute and the civil monetary penalty law prohibiting beneficiary inducement. Clinicians are not obligated to reduce or waive Medicare beneficiary coinsurance and deductible obligations, but may do so in accordance with the OIG policy statement without risk of anti-kickback or beneficiary inducement enforcement. Moreover, the OIG states that it will not view providing future services that may occur as a result of any free telehealth services to, by itself, be evidence of beneficiary inducement. The OIG Policy Statement can be found here. These CMS and OIG issuances are intended to give providers added flexibility to combat the COVID-19 emergency. Hospitals and other providers should consider how the temporary Medicare telehealth expansion and the flexibility in dealing with beneficiary cost-sharing can help them keep clinicians and beneficiaries safer, alleviate some of the burden on provider staff and space, and help reduce the spread of COVID-19. If you have any questions, please contact the author or any member of Dorsey’s healthcare transactions and regulations practice group.
March 18, 2020
by Ross C. D'Emanuele
Telemedicine
Controlled Substance Prescribing Exceptions During Public Health Emergencies
In light of the novel coronavirus pandemic, health care practitioners should be aware of relaxed guidelines for prescribing controlled substance. This blog post describes when practitioners can prescribe controlled substances via telemedicine and exceptions available to opioid treatment programs. Telemedicine Prescribing Typically, an in-person medical evaluation must be conducted before a prescription for a controlled substance is issued through telemedicine or other internet means. However, when the Secretary of Health and Human Services has declared a public health emergency, as he recently did, prescribers may utilize an exception to the in-person evaluation requirement. For as long as the Secretary’s designation of a public health emergency remains in effect, DEA-registered practitioners may issue prescriptions for controlled substances to patients for whom they have not conducted an in-person medical evaluation, provided all of the following conditions are met: The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of their professional practice; The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system; and The practitioner is acting in accordance with applicable Federal and State law. As long as the practitioner satisfies all of these requirements, the prescription may be issued using any method of prescribing currently set forth in DEA regulations. Thus, the practitioner may issue a prescription either electronically (for schedules II-V), by calling in an emergency schedule II prescription to a pharmacy, or by calling in a schedule III-V prescription to the pharmacy. Note that regardless of whether there is a public health emergency, a prescribing practitioner that has previously conducted an in-person medical evaluation of a patient may issue a prescription for a controlled substance after communicating with the patient via telemedicine. The prescription must still be issued for a legitimate medical purpose and comply with applicable Federal and State law. More information about the DEA-response to the coronavirus may be found here. Medications for Patients with Opioid Use Disorders Additionally, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) has also issued guidance regarding medications for patients with opioid use disorders in treatment programs. If a state has declared a state of emergency, the state may request blanket exceptions for all stable patients in an Opioid Treatment Program (OTP) to receive 28 days of take-home doses of the patient’s medication for opioid use disorder. The state may request up to 14 days of take-home medication for those patients who are less stable, but who the OTP believes can safely handle this level of take-home medication. In states that have not declared states of emergency, an OTP can provide a blanket exemption request for its clinic per the guidance above (i.e., up to 28 days for stable patients and up to 15 days for less stable patients). These requests do not have to be submitted on a per-patient basis. Programs and states should use appropriate clinical judgment and existing procedures to identify stable patients. SAMHSA notes that as an increased medication supply will likely accompany these requests, OTPs and states must ensure that there is enough medication ordered and on hand to meet patient needs. We are continuing to monitor the federal response to the coronavirus pandemic and will continue to post updates. If you have any further questions, please contact the authors of this post or your regular Dorsey attorney.
March 18, 2020
by Alissa Smith and Charis Zimmick
Telemedicine
Reimbursement for Remote Patient Monitoring Services in 2019
Medicare reimbursement for remote patient monitoring has taken a number of steps forward throughout this year. New and proposed rules from the Centers for Medicare and Medicaid Services both expand the billing options available to health care providers and also build in additional flexibility in the provision of remote patient monitoring in order to further the health industry’s push to value-based care. Remote patient monitoring (“RPM”) is a form of digital health in which medical data from individual patients is collected in one location and electronically transmitted to health care providers in a different location for assessment and recommendations. RPM differs from other digital health services in that there is not necessarily a live, or “real-time”, interaction between the patient and their health care provider. Instead, RPM is used by health care providers to monitor various aspects of their patient’s vital signs, including: weight, blood pressure, blood sugar, heart rate, and oxygen levels. RPM is not only a useful tool for health care providers to use during a patient’s hospitalization, but it is also useful in reducing the number of hospitalizations altogether. For example, RPM can be used to allow older or disabled individuals to live at home longer and avoid having to move into skilled nursing facilities, since their vitals can be monitored without having to see a health care provider in person. Until this year, Medicare reimbursement for RPM services was difficult to come by. While Medicare previously offered reimbursement for RPM services billed under CPT code 99091, the code did not take current technology and staffing models into account (likely because the language from the code dates back roughly 16 years). In order to address this issue and further incentivize health care providers to use RPM, the Centers for Medicare and Medicaid Services (“CMS”) finalized three new RPM billing codes that were effective January 1, 2019 (“Final Rule”). The new codes are titled, “Chronic Care Remote Physiologic Monitoring” and included the following descriptions: CPT code 99453: “Remote monitoring of physiologic parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), initial; set-up and patient education on use of equipment.” CPT code 99454: “Remote monitoring of physiologic parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), initial; device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30 days.” CPT code 99457: “Remote physiologic monitoring treatment management services, 20 minutes or more of clinical staff/physician/other qualified healthcare professional time in a calendar month requiring interactive communication with the patient/caregiver during the month.” Finalization of these new codes did not come without fair criticism and disparate interpretations of the level of required supervision. In creating the codes, CMS stated that RPM could not be delivered “incident to” a practitioner’s professional services. Therefore, RPM services could not be reimbursed if the services were furnished by auxiliary personnel (individuals acting under the supervision of a physician). Following backlash of this conclusion, CMS issued a technical correction to the Final Rule on March 14, 2019, that allows “incident to” billing of RPM services by auxiliary personnel if they are under direct supervision. This was overall a win for RPM reimbursement; however, through separate codes (CPT 99487, 99489, and 99490), CMS allows reimbursement for Chronic Care Management under general supervision. The difference being that general supervision does not require a physician to be in the same building at the same time as the auxiliary personnel delivering the services. This contradictory treatment resulted in commentators arguing that CMS’s approach hinders, rather than increases, a patient’s access to digital health services by limiting where a physician may be located during the supervision of such services. CMS seems to be addressing this concern in the proposed 2020 Physician Fee Schedule that was published August 14, 2019 (“Proposed Rule”). The Proposed Rule would allow “incident to” RPM services to be reimbursed under general supervision rather than limiting reimbursement to direct supervision. By way of example, this means RPM could be reimbursed when the auxiliary personnel use RPM with patients who are in a hospital while the auxiliary personnel are supervised via other telemedicine modalities by a physician at their home. This change would greatly improve a patient’s access to RPM by enabling physicians to bill for such services delivered in a more flexible manner. In addition to this change, the Proposed Rule revises CPT code 99457 and adds yet another code to allow for additional reimbursement for each 20-minute interval that RPM services are provided. This is in contrast to the Final Rule’s version of CPT code 99457, which allowed only one reimbursement for RPM services delivered for 20 minutes or more. CMS is accepting comments on the Proposed Rule until September 27, 2019. If you would like to submit comments or have any questions, one of the authors or your regular Dorsey attorney would be happy to assist you.
September 20, 2019
by Randall Hanson and Ross C. D'Emanuele
