key: cord-354247-erzak928
authors: Iain Pritchard, Roger; Huff, Jamie; Scheinberg, Nataliya
title: Impact of Regulatory Changes on Pharmacist Delivered Telehealth During the COVID-19 Pandemic
date: 2020-06-15
journal: J Am Pharm Assoc (2003)
DOI: 10.1016/j.japh.2020.06.004
sha: 
doc_id: 354247
cord_uid: erzak928

Summary: The 2020 COVID-19 pandemic in the United States has created a dramatic need for the rapid implementation of telehealth services in areas of the country where telehealth is limited in scope.1 This implementation would not be possible without significant changes in how the Centers for Medicare and Medicaid Services (CMS) provide reimbursement for these services. In this brief review we intend to evaluate what regulatory changes have occurred, the impact of these changes, and additional opportunities for outpatient pharmacists to receive compensation while providing distant healthcare.

The 2020 COVID-19 pandemic in the United States has created a dramatic need for the rapid implementation of telehealth services in areas of the country where telehealth is limited in scope. 1 This implementation would not be possible without significant changes in how the Centers for Medicare and Medicaid Services (CMS) provide reimbursement for these services. In this brief review we intend to evaluate what regulatory changes have occurred, the impact of these changes, and additional opportunities for outpatient pharmacists to receive compensation while providing distant healthcare.

Article Text:

The 2020 COVID-19 pandemic in the United States has created a dramatic need for the rapid implementation of telehealth services in areas of the country where telehealth is limited in scope. 1 This implementation would not have been possible without significant changes in how the Centers for Medicare and Medicaid Services (CMS) provide reimbursement for telehealth. In this brief review, we intend to evaluate what regulatory changes have occurred, the impact of these changes, and additional opportunities for outpatient pharmacists to receive compensation while providing distant healthcare.

Traditionally, the Health Resources and Services Administration (HRSA) defines telehealth as the use of electronic information and telecommunication technologies to support long-distance clinical health care, patient and professional health related education, public health, and health administration. 2 Prior to the implementation of COVID-19 waivers, access to telehealth services for Medicare patients was mostly restricted to areas of the country defined as non-Metropolitan Statistical Areas (MSA) or rural Health Professional Shortage Areas (HPSA). Some exceptions to these location requirements were made for patients with end stage renal disease, acute stroke, and substance use disorder with concomitant mental health conditions. In addition to location restrictions, Medicare also requires that Medicare telehealth appointments are delivered through synchronous audio and visual telecommunication that permit real-time communication, utilize a platform that is considered HIPAA compliant, and occur between providers with an established patient and provider relationship. 3 Medicare and private insurers have also reimbursed for telehealth services at a reduced rate. These restrictions combined with reduced compensation have contributed to telehealth services being a nonpreferred option for many providers.

In 2019, CMS lifted some restrictions to telehealth and began reimbursing providers for services that utilized additional telecommunication approaches, which included virtual check-ins, remote evaluation of pre-recorded patient information, and interprofessional internet consultations. A virtual check-in is a brief communication delivered synchronously with an established patient and is intended to be patient-initiated access to care. Remote evaluation of pre-recorded information is as stated, the evaluation of recorded information by qualified healthcare providers that is utilized to determine if a patient visit or other service may be necessary. Interprofessional internet consultations are a pathway for providers to seek reimbursement when consulting occurs through the telephone or asynchronously through the internet. This consultation awards compensation to the provider whose is being consulted only. Additionally, these services did not have the same location restrictions as mentioned for other Medicare telehealth services. Unfortunately, none of these newer telehealth services or standard Medicare telehealth services allowed pharmacists to seek compensation for their time. 3 While compensation challenges make it difficult for pharmacists to utilize telehealth, they have still been engaged in providing these services to patients. When providing telehealth services, pharmacists have been able to show a significant impact on patient-centered outcomes. A 2012 article by McFarland et al. showed that in patients accessing clinical pharmacy services through telehealth, there was a significant difference between patients achieving A1C goals at 3 months and 6 months as compared to patients not utilizing telehealth when accessing pharmacy services. 4 Improvements in patient centered outcomes have also been seen with the management of hypertension; a 2013 JAMA study by Margolis et al. showed that as compared to usual patient care, telehealth monitoring of patients' blood pressure by pharmacists improved control at 6, 12, and 18 months. 5 Pharmacists have also been able to show significant improvements in patient centered outcomes in readmissions for chronic obstructive pulmonary disease and heart failure exacerbations, control of INR, achievement of tobacco cessation, and the use of lipid lowering medications. 6, 7 These documented improvements in outcomes show not only that utilizing telehealth can improve patient care, but that pharmacists are successful at implementing it and should be reimbursed for providing patient care.

In response to the COVID-19 pandemic, the CMS took action on March 17th to expand access to telehealth services through a waiver to Section 1135 of the Social Security Act which allows for temporary modifications to Medicare, Medicaid, and the Children's Health Insurance Program (CHIP) during a national emergency. Under this waiver, CMS authorized the delivery of Medicare telehealth services throughout the nation. This waiver allowed for designated providers to deliver services that would otherwise occur in-person through telehealth at the regular, not reduced rate of reimbursement. Additionally, CMS stated that the Department of Health and Human Services (HHS) would not conduct audits that targeted the verification of established relationships between a provider and patient. With the expected expansion of Medicare telehealth appointments due to these changes, CMS also announced that "the HHS office for Civil Rights would be exercising enforcement discretion and waive penalties for HIPAA violations against providers serving patients in good faith through everyday communication technology", which allows providers to use services such as FaceTime, Skype, and Zoom to complete Medicare telehealth services. 8 In addition to expanding access to Medicare telehealth services, CMS also emphasized that providers may continue to utilize virtual check-ins and E-visits. For many providers utilizing these options is important because unlike Medicare telehealth services there is not a requirement for both real-time audio and visual communication, but simply a synchronous discussion for a virtual check-in, or an asynchronous discussion for an E-visit. The lack of need for both real-time audio and visual communication allows for the provision of these services though a broader range of communication modalities, including the use of patient portals, telephones, and secure text messaging. Both E-visits and virtual check-ins are specific telehealth provisions and are reimbursed at their own rates. 3 Unfortunately, despite the implementation of significant waivers that allow physicians, nurse practitioners , and qualified non-physician healthcare professionals, such as physician assistants, physical therapists, and clinical social workers, to continue to provide a wide range of services for their patients, pharmacists appear to be mostly excluded from these federal provisions. As outpatient pharmacists may utilize an "incident-to" model to bill for their services, it has been questioned if this will continue to be feasible given the lack of specific mention of pharmacists as eligible telehealth providers in the aforementioned waivers.

On March 30 th ,CMS released an updated guidance document providing clarification on some "incident-to" requirements, and included that direct supervision would be allowed through the use of real-time audio/video technology. Under normal circumstances, direct supervision would require the billing provider to be available in the same location as the service being performed. Additionally, CMS indicated that providers can enter into a contractual arrangement with auxiliary personnel, which includes pharmacists, so that services that would be provided "incident-to" a physician's service may continue to be delivered. 9 Unfortunately, what this guidance did not do is change the eligibility of pharmacists to be compensated for telehealth services under Medicare. So, despite changes to supervision requirements and reinforcement that pharmacists are considered auxiliary personnel, the ability for pharmacists to be compensated for telehealth services remains limited. National pharmacy organizations have taken note of this and are advocating for changes. On April 6th, the American Pharmacists Association (APhA) contacted CMS administrator Seema Verma advocating for the HHS Secretary Alex Azar to use new authority granted under the CARES act to include pharmacists in telehealth provisions. 10 However, as of May 18 th , 2020 , no additional changes to existing law have taken place that specifically allow pharmacists to receive compensation for necessary services delivered through telehealth.

Regulatory hurdles will continue to impact pharmacists' ability to deliver telehealth until they are recognized as providers under Title XVII of the Social Security Act, which established Medicare . However, lack of provider status does not mean pharmacists cannot continue to provide high quality patient care and be compensated for the high-quality care they provide. Many Medicare patients who receive chronic disease state management by pharmacists are likely eligible for chronic care management (CCM). In 2015 Medicare began to compensate providers for their efforts in managing a patient's chronic disease states via CCM. Under this program pharmacists who are either directly employed by the clinician or a contracted third party and whose services are generally supervised by the clinician may count as clinical staff time for CCM billing purposes. What is of particular importance during the COVID-19 pandemic is that direct supervision, which as stated above is required for "incidentto" billing, is not a requirement for CCM. Rather, general supervision is allowed which is when care is delivered under the direction of a provider, but their physical presence is not required. This flexibility may provide an avenue for pharmacists to continue disease state management through collaborative practice agreements when providers and patients are unable to be present due to the ongoing COVID-19 pandemic. 11 In addition to CCM, pharmacists can also consider using disease state specific codes that allow for remote evaluation of patient data. Specifically, these are available for patients who are on anticoagulation or utilizing continuous glucose monitoring (CGM). These were available prior to COVID-19 but may not have been utilized with other CPT codes that provided higher rates of reimbursement for patients seen in person. Given the limitations in utilizing "incident-to" billing during this crisis, Table 1 identifies some of the above suggested CPT codes with the approximate level of reimbursement, and general requirements. With compensation options limited, pharmacists may also take advantage of situations in which they can work in collaboration with other healthcare providers to deliver care. As many providers have also made a switch to telehealth models, this is an opportunity for outpatient pharmacists to work in interprofessional teams in order to continue providing the highquality patient care they were providing prior to COVID-19. While pharmacists may not directly bill for these services, the impact of our skills in direct patient care should not be lost.

While CMS has made limited changes to pharmacists' ability to deliver telehealth, some states have been specific in their orders that pharmacists are considered providers that can deliver telehealth services; these states include Arizona, Illinois, and North Carolina. 16 -18 North Carolina has also been specific to ensure that clinical pharmacists are considered to be an eligible distant site telemedicine provider, meaning that they provide telehealth services from any location during the pandemic. While not all states have been specific in mentioning pharmacists as providers, a number of states consider pharmacists providers and wording of executive orders or Medicaid directives would therefore include pharmacists as eligible to deliver telehealth services. Despite this, several states do not include pharmacists in COVID related waivers or executive orders, which may create an unnecessary burden as pharmacists seek to continue the delivery of care to patients who require it. For continued updates on changes to state and federal regulations as it relates to telehealth and the COVID-19 pandemic, we suggest utilizing resources found at the Center for Connected Health Policy. 19 Their website contains a routinely updated compilation of all regulatory announcements on this subject, at both the federal and state levels.

Pharmacists provide high quality care that directly impacts the lives of many patients in this nation. As the nation expands the delivery of care with the telehealth model during the COVID-19 pandemic, pharmacists are excluded from seeking compensation for the care they provide. While some reimbursement options remain open to pharmacists, they depend upon local regulation or the ability of a site to alter practice. This overview of regulatory changes shows that despite significant strides in telehealth service compensation for healthcare providers, pharmacists continue to lack the ability to seek appropriate compensation for their direct patient care services.

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