key: cord-0902966-d9gzymzc authors: Dey, Pranam; Jarrin, Robert; Mori, Makoto; Geirsson, Arnar; Krumholz, Harlan M. title: Leveraging Remote Physiologic Monitoring in the COVID-19 Pandemic to Improve Care After Cardiovascular Hospitalizations date: 2021-04-06 journal: Circ Cardiovasc Qual Outcomes DOI: 10.1161/circoutcomes.120.007618 sha: 0c784203c8689c4e80233eaf7292b9dc7e9d138b doc_id: 902966 cord_uid: d9gzymzc nan arly in the COVID-19 pandemic, much of in-person clinic visits rapidly shifted to virtual platforms. 1 This wide-scale digital transition made broader use of remote physiologic monitoring (RPM) a tangible possibility. Clinicians may leverage this opportunity to better monitor posthospital recovery, where changes in physiologic parameters could be measured remotely and frequently to better understand patients' recovery courses and possibly intervene. Recent policymaking by the Food and Drug Administration and Centers for Medicare & Medicaid Services (CMS) in response to the COVID-19 pandemic has facilitated the use of RPM and other digital health tools by expanding current uses of existing technologies and increasing reimbursement flexibility. 2 Practices surrounding cardiovascular disease present a unique opportunity for many of the hemodynamic and cardiovascular parameters that can be measured remotely. We explore how services for cardiovascular patients may be reimbursed via RPM and how innovative monitoring may transform current practices. RPM refers to using noninvasive medical monitoring devices-like pulse oximetry devices and ECG-to measure the physiologic data of patients anywhere they may be. 3 RPM automatically uploads patient physiologic data from medical devices, without requiring intermediary steps by patients to self-record and transcribe information. As part of its COVID-19 response, the Food and Drug Administration announced on March 20th a temporary policy change allowing modifications to the indications, claims, functionality, or hardware or software of certain noninvasive remote monitoring devices. 3 The change in policy sought to expand the capability and availability of noninvasive remote monitoring devices, including allowing in-home use for some devices previously marketed for hospital or other health care facility use only, and allowances for cardiac monitors, electrocardiograph, and electrocardiograph software for over-the-counter use. The Food and Drug Administration's guidance allows device modifications to increase monitoring capabilities such as the addition of Bluetooth or wireless capabilities, thus offering further possibilities to minimize direct patient contact even when caring for patients in the hospital. An example where this may augment care is in the postoperative monitoring of cardiac surgery patients, for whom the risk of atrial fibrillation is high, and frequently extends beyond hospital discharge. The regulatory changes to accelerate the growth of RPM related to the pandemic are just a part of a broader move toward a more flexible system that allows patients Leveraging Remote Physiologic Monitoring in the COVID-19 Pandemic to Improve Care After Cardiovascular Hospitalizations and their clinicians to use the best available modality. Since 2018, CMS has provided coverage and payment for remote patient monitoring (Current Procedural Terminology [CPT] code 99091) and since 2019, for RPM treatment management services (CPT code 99457) by way of annual additions to the Physician Fee Schedule. 4 In January 2020, the fee schedule built upon CPT code 99457 that covers the first 20 minutes per month of RPM treatment management services (time requiring interactive communication with the patient) by creating the new additional CPT code 99458 that covers a subsequent 20 minutes per month. Both CPT codes 99457 and 99458 are valued at 0.61 work relative value units and require communication between the provider and the patient or caregiver (Table) . 5 Therefore, monitoring postoperative data for individual patients by various means could generate up to 0.61 relative value units per month. During the COVID-19 public health emergency, CMS made the important and permanent clarification that providers can furnish CPT code 99457 and 99458 for acute and chronic conditions, meaning monitoring could be reimbursed even during the postacute phase. Additionally, for the duration of the public health emergency, CMS allows both new and existing patients annual consent, and if providers so choose, they may waive or reduce cost-sharing obligations thanks to nonenforcement of administrative sanctions. 6 Perhaps most importantly, already permitted CMS reimbursement under general supervision allows for the provision of RPM by an auxiliary care team member under the overall direction and control of the physician or other qualified health care professional whose presence is not required during the performance of the service. For example, a nurse practitioner could file a claim for 99457 for spending >20 minutes a month monitoring the ECG, oxygen saturation, and blood pressure transmitted from wearable devices of a posthospital patient, modifying the recovery treatment plan accordingly, and discussing the data and treatment plan with patients and caregivers. In short, claiming relative value units for CPT codes 99457 and 99458 requires a physician, qualified health care professional, or supervised clinical staff member, such as nurses, to review and interpret remotely transmitted patient data and modify the treatment plan using interactive communication with patients or caregivers as necessary, for a combined 40 minutes, per patient, per month. CPT code 99091 requires a physician or qualified health care professional (not clinical staff members) to spend 30 minutes per patient per month collecting and interpreting physiologic data, without requiring communication with the patient. Remote posthospital monitoring remains underused, but the greater regulatory flexibility and increased Medicare reimbursement from CPT codes 99457/99458 and 99091 and the clinical safety imperatives of the pandemic make it both easier and more important than ever to achieve the potential of RPM. An important additional flexibility enabling the rapid adoption of remote communications was the Department of Health and Human Services Office of Civil Rights exercise of enforcement discretion to not impose penalties for Health Insurance Portability and Accountability Act violations when physicians use popular voice and video technologies during the COVID-19 national emergency. 7 This allows physicians to use programs including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, Zoom, or Skype to communicate with patients. This flexibility to use widespread platforms without compliance issues may facilitate the growth of RPM by decreasing the barriers to entry, as CPT codes 99457 and 99458 require interactive communication with patients or caregivers. Maintaining COVID-era platform flexibilities in the long term has the potential to streamline RPM adoption and implementation, even as we wait for more commercial platforms to attain Health Insurance Portability and Accountability Act compliance. Recovery after hospital discharge had not been monitored routinely outside of occasional clinic visits. The combination of increased regulatory flexibility and reimbursement for RPM radically expands how much of the posthospital recovery process physicians can remotely monitor and manage. Limited evidence suggests the use of digital health technologies offering frequent monitoring may improve patients' recovery. 8 Evidence from postoperative monitoring of heart failure patients with implanted cardioverter-defibrillators suggests RPM can safely replace some in-person postoperative visits. 9 Before the COVID-19 pandemic, implementation challenges due to infrastructural (such as integration with electronic health record technologies) and financial barriers impeded adoption of RPM. 10 With newly expanded RPM use and reimbursement rules, cardiovascular care providers have a unique window of opportunity during the CO-VID-19 pandemic to leverage RPM both to meet the pandemic's social distancing imperatives by providing safer, at-home care and to use the vast amounts of real-time data from home monitoring devices as fuel for the learning health system of the future. It will be important to continue to generate data to support practice and to be aware of potential unintended consequences-more frequent monitoring via RPM may contribute to patient anxiety or overdiagnosis resulting in excess health care utilization. CMS seems concerned enough to have recently clarified that RPM services associated with all medical devices for a single patient can be billed by only 1 practitioner, only once per patient per a 30-day period, when at least 16 days of data have been collected. However, it is the adaptability of RPM that makes it attractive for existing posthospital care programs to monitor rehabilitation intensity and recovery. Managing this new deluge of RPM-generated data will require effective filters to relay only high-yield information to physicians. The COVID-19 pandemic heralded the beginning of the digital health era. Regulatory changes from CMS, the Food and Drug Administration, and the Department of Health and Human Services Office of Civil Rights have dramatically accelerated the growth of digital health of all kinds, including RPM. For the first time, hospitals have the regulatory leniency and financial reimbursement frameworks to scale-up RPM adoption. As there is enormous potential in improving postoperative recovery monitoring by the effective use of RPM and telehealth technologies, cardiologists and cardiac surgeons should consider the potential benefits of adopting these technologies in daily practice. With the development of new CPT codes and large-scale adoption of technology as a byproduct of the pandemic, now is the time to start tapping into this opportunity that had been underutilized for so long. The Impact of the COVID-19 Pandemic on Outpatient Visits: A Rebound Emerges Rapidly Converting to "Virtual Practices": Outpatient Care in the Era of Covid-19 Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Quality Payment Program Quality Payment Program-Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions From the Medicare Shared Savings Program-Accountable Care Organizations-Pathways to Success Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act Medicare Program; CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion Regulations Final Rule; and Coding and Payment for Evaluation and Management, Observation and Provision of Self-Administered Esketamine Interim Final Rule Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency. U.S. Department of Health & Human Services Office for Civil Rights Assessment of patient ambulation profiles to predict hospital readmission, discharge location, and length of stay in a cardiac surgery progressive care unit Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator: primary results of the REMOTE-CIED randomized trial Association between hospital penalty status under the hospital readmission reduction program and readmission rates for target and nontarget conditions