Letter to Congress Urging Action on Telehealth
Congress Must Act to Ensure Patients and Providers Don’t Fall Off the “Telehealth Cliff” When Public Health Emergency Ends
Today, 340 organizations signed a letter urging Congressional leaders to make telehealth flexibilities created during the COVID-19 pandemic permanent. Those signing this multi-stakeholder letter include national and regional organizations representing a full range of health care stakeholders and all 50 states, the District of Columbia, and Puerto Rico.
Congress quickly waived statutory barriers to allow for expanded access to telehealth at the beginning of the COVID-19 pandemic, providing federal agencies with the flexibility to allow healthcare providers to deliver care virtually. If Congress does not act before the COVID-19 public health emergency expires, current flexibilities will immediately disappear.
Therefore, 340 stakeholders have sent a powerful message to Congress outlining the immediate actions necessary to ensure CMS has the authority to continue to make telehealth services available once the national health emergency is rescinded:
- Remove obsolete restrictions on the location of the patient to ensure that all patients can access care at home, and other appropriate locations;
- Maintain and enhance HHS authority to determine appropriate providers and services for telehealth;
- Ensure Federally Qualified Health Centers and Rural Health Clinics can furnish telehealth services after the public health emergency; and
- Make permanent Health and Human Services (HHS) temporary waiver authority for future emergencies.
While federal agencies can address some of these policies going forward, the Centers for Medicare and Medicaid (CMS) does not have the authority to make changes to Medicare reimbursement policy for telehealth under the outdated Section 1834(m) of the Social Security Act. Following these priorities will allow CMS to build on the experience gained during the pandemic and expand access to telehealth in a thoughtful, data-driven way.
Letter to Alexander Preparing for the Next Pandemic
The Alliance submitted comments to Senate Finance Committee Chair Alexander’s white paper outlining recommendations and important questions to better prepare for future pandemics.
Public Health Capabilities – Improve State and Local Capacity to Respond
- Make permanent HHS temporary telehealth waiver authority during emergencies
- Facilitate telehealth care across state borders
- Expand broadband access to ensure access to care
Home monitoring with technology-supported management in chronic heart failure: a randomised trial
Home monitoring with technology-supported management in chronic heart failure: a randomised trial
Objectives We aimed to investigate whether digital home monitoring with centralised specialist support for remote management of heart failure (HF) is more effective in improving medical therapy and patients’ quality of life than digital home monitoring alone.
Methods In a two-armed partially blinded parallel randomised controlled trial, seven sites in the UK recruited a total of 202 high-risk patients with HF (71.3 years SD 11.1; left ventricular ejection fraction 32.9% SD 15.4). Participants in both study arms were given a tablet computer, Bluetooth-enabled blood pressure monitor and weighing scales for health monitoring. Participants randomised to intervention received additional regular feedback to support self-management and their primary care doctors received instructions on blood investigations and pharmacological treatment. The primary outcome was the use of guideline-recommended medical therapy for chronic HF and major comorbidities, measured as a composite opportunity score (total number of recommended treatment given divided by the total number of opportunities the treatment should have been given, with a score 1 indicating 100% adherence to recommendations). Co-primary outcome was change in physical score of Minnesota Living with Heart Failure questionnaire.
Results 101 patients were randomised to ‘enhanced self-management’ and 101 to ‘supported medical management’. At the end of follow-up, the opportunity score was 0.54 (95% CI 0.46 to 0.62) in the control arm and 0.61 (95% CI 0.52 to 0.70) in the intervention arm (p=0.25). Physical well-being of participants also did not differ significantly between the groups (17.4 (12.4) mean (SD) for control arm vs 16.5 (12.1) in treatment arm; p for change=0.84).
Conclusions Central provision of tailored specialist management in a multi-morbid HF population was feasible. However, there was no strong evidence for improvement in use of evidence-based treatment nor health-related quality of life.
Diabetes Telehealth Solutions: Improving Self-Management Through Remote Initiation of Continuous Glucose Monitoring
Journal of Endocrine Society: Diabetes Telehealth Solutions: Improving Self-Management Through Remote Initiation of Continuous Glucose Monitoring
The purpose of this study was to evaluate feasibility of initiating continuous glucose monitoring (CGM) through telehealth as a means of expanding access. Substantial benefits of CGM to quality of life were observed, with reduced diabetes distress, increased satisfaction with glucose monitoring, and fewer perceived technology barriers to management. Remote CGM initiation was successful in achieving sustained use and improving glycemic control after 12 weeks as well as improving quality-of-life indicators. If widely implemented, this telehealth approach could substantially increase the adoption of CGM and potentially improve glycemic control for people with diabetes using insulin.
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Open in new tab Connected Care Clips – June 19
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Healthcare Leaders Form Taskforce on Telehealth
Healthcare Leaders Form Taskforce on Telehealth Policy
View a pdf version here.
Amidst an unprecedented increase in the use of remote medical services, 20 of the nation’s leading healthcare voices today announced the formation of a Taskforce on Telehealth Policy aimed at developing long-term recommendations. The taskforce will be convened by the National Committee for Quality Assurance, Alliance for Connected Care, and the American Telemedicine Association (ATA).
The group – representing a broad spectrum of plans, providers, consumer advocates and health-quality experts from the public, private and non-profit sectors – will develop consensus recommendations for policymakers on how to maximize the benefits of telehealth services while maintaining high standards for patient safety and program integrity. Other priorities to be addressed include the integration of remote care into the healthcare ecosystem and ensuring the quality, accessibility, and efficacy of telehealth.
The need for a comprehensive review of telehealth policy is highlighted by some remarkable data collected since March. Every element of healthcare has been affected by the major increases in telehealth and remote patient care. Many patients and providers have experienced the capabilities of telehealth for the first time and are interested in continuing to use it. Traditional (fee-for-service) Medicare has seen the number of remote visits increase from roughly 12,000 per week to over a million per week, according to recent comments from Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma.
The Commonwealth Fund found that, in the mid-April peak of the current spread, in-person visits fell by nearly 70 percent, with telehealth visits offsetting as much as 20 percent of that decline. Many public and private payers, including CMS, have substantially relaxed telehealth restrictions during the pandemic.
“We need to get this moment in healthcare right by optimizing the quality and value of telehealth for everyone,” said NCQA President Margaret (Peggy) O’Kane. “The fact that such an accomplished group of people are willing to dedicate their time, on short notice, to this task speaks to how high the stakes truly are.”
“The value of telehealth during this emergency is undeniable, and the policy changes that were made by Congress and the Trump Administration were essential,” said Alliance for Connected Care Executive Director Krista Drobac. “This taskforce can take what we have collectively learned in the past three months and develop thoughtful recommendations that will provide access to remote care for the long term while balancing cost, quality and judicious use of taxpayer dollars.”
“The ATA was proud to represent our industry at yesterday’s Senate Committee on Health, Education, Labor and Pensions hearing on telehealth, helping to build the case for extending access to virtual care indefinitely. This Telehealth Policy Task Force will help to maintain a strong, unified, and compelling voice needed to cement those gains,” added Ann Mond Johnson, CEO, the ATA. “Telehealth has played a vital role in responding to the pandemic, driving a rapid transformation in how care is delivered. Working together, we must ensure access to care for all who need it.”
The Taskforce on Telehealth will hold its first meeting on Monday, June 29, and deliberate through the summer. Final recommendations will be issued in early September. A full list of Taskforce on Telehealth members is below.
Peter Antall, MD, Chief Medical Officer, Amwell
Regina Benjamin, MD, Chief Executive Officer, BayouClinic/Gulf States Health Policy Center, former Surgeon General of the United States
Krista Drobac, Executive Director, Alliance for Connected Care
Yul Ejnes, MD, Clinical Associate Professor of Medicine, Brown University; Board of Regents Chair-Emeritus, American College of Physicians
Rebekah Gee, MD, Chief Executive Officer, Louisiana State University Health System
Nancy Gin, MD, Executive Vice President of Quality & Chief Quality Officer, Kaiser Permanente Federation
Kate Goodrich, MD, Senior Vice President Trend and Analytics, Humana
Ann Mond Johnson, Chief Executive Officer, American Telemedicine Association
Chuck Ingoglia, President & Chief Executive Officer, National Council for Behavioral Health
Chris Meyer, Director of Virtual Care, Marshfield Clinic
Megan Mahoney, MD, Chief of Staff, Stanford Health Care, Clinical Professor, Division of Primary Care and Population Health, Stanford University
Peggy O’Kane, President, National Committee for Quality Assurance
Sean Cavanaugh, Chief Administrative Officer, Aledade
Kerry Palakanis, DNP, APRN, Executive Director, Connected Care Operations, Intermountain Healthcare
Nicholas Uehlecke, Federal Liaison, US Department of Health & Human Services (non-voting)
Michelle Schreiber, MD, Director, Quality Measurement & Value-Based Incentives Group, Center for Clinical Standards & Quality, Centers for Medicare & Medicaid Services
Dorothy Siemon, JD, Senior Vice President for Policy Development, AARP
Julia Skapik, MD, MPH , Medical Director, Informatics, National Association of Community Health Centers
Jason Tibbels, MD, Chief Quality Officer, Teladoc Health
Andrew Watson, MD, Vice President, University of Pennsylvania Medical Center
Cynthia Zelis, MD, MBA, Chief Medical Officer, MD Live
CDC Telehealth Guidance
Using Telehealth to Expand Access to Essential Health Services during the COVID-19 Pandemic
CDC issued guidance for healthcare systems, practices, and providers using telehealth services to provide virtual care during and beyond the COVID-19 pandemic. The guidance describes the landscape of telehealth services, provides strategies to increase telehealth uptake, and offers potential limitations of telehealth – one of which includes interstate licensure challenges and other regulatory issues that may vary by state.
The guidance can be viewed here.
View more telehealth guidance on our COVID-19 Resources page
Other Telehealth Guidance Documents
Guidance on Fraud and Anti-kickback Regulations from the HHS Inspector General
In response to the public health emergency, leading provider organizations and the Alliance for Connected Care expressed interest in ensuring the ability of providers to waive co-pays or provide some telehealth services at no cost — to encourage more seniors to access needed care. These waivers would normally implicate the federal anti-kickback statute, the Civil Monetary Penalty and Exclusion Law related to kickbacks, and the Civil Monetary Penalty Law’s prohibition on inducements to beneficiaries.
On March 17, the HHS Office of the Inspector General (OIG) issued a policy statement assuring providers that they could make these changes without risk of triggering the Federal anti-kickback statute, the civil monetary penalty and exclusion laws related to kickbacks, or the civil monetary penalty law prohibition on inducements to beneficiaries. In a supplemental FAQ, OIG indicated that the policy is not limited to services defined by CMS as “telehealth visits” and instead applies to a broad category of non-face-to-face services furnished through various modalities including telehealth visits, virtual check-in services, e-visits, monthly remote care management, and monthly remote patient monitoring.
On April 3, HHS OIG issued a policy statement stating that the agency will exercise its enforcement discretion not to impose administrative sanctions for certain Stark Law violations that had been waived by HHS during the public health emergency. The Physician Self-Referral Law, commonly referred to as the Stark law, prohibits physicians from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies.
- April 23 OIG Advisory Opinion
- April 3 OIG – Stark Law Policy Statement
- March 24 Frequently Asked Questions
- March 17 OIG Policy Statement
- March 17 OIG Factsheet
Guidance for Federally Qualified Health Centers and Rural Health Clinics from the Centers for Medicare and Medicaid Services
The CARES Act added Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) to the list of eligible providers. This change allows FQHCs and RHCs to act as distant site providers allowing them to provide telehealth services for the duration of the public health emergency.
In response to the new changes, CMS posted an article for RHCs and FQHCs on expanded flexibilities during the COVID-19 public health emergency for services provided to Medicare beneficiaries.
These new flexibilities include:
- New payment for telehealth services, including how to bill Medicare
- Expansion of virtual communication services
- Revision of home health agency shortage requirement for visiting nursing services
- Consent for care management and virtual communication services
- Accelerated/advance payments
Guidance on Telemedicine Prescribing of Controlled Substances from the Drug Enforcement Administration
While a prescription for a controlled substance issued by means of the Internet (including telemedicine) generally requires an in-person medical evaluation, the Controlled Substances Act contains certain exceptions to this requirement. One such exception occurs when the Secretary of Health and Human Services has declared a public health emergency. Traditionally, a prescribing practitioner who has previously conducted an in-person medical evaluation may issue a prescription for a controlled substance regardless of whether a public health emergency has been declared.
The Drug Enforcement Administration announced that 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 (as defined under Section 802(54)(D):
- The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice
- The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system.
- The practitioner is acting in accordance with applicable Federal and State law.
Guidance from the Food and Drug Administration (updated June 5)
Remote Patient Monitoring
On June 5, FDA issued updated guidance to expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of the COVID-19 public health emergency. In the new guidance, the agency said it will not object to limited modifications to the indications, claims, functionality, or hardware or software the devices, listed here, as long as they do not impose undue risk.
On April 23, FDA issued guidance on non-invasive fetal and maternal monitoring used to support patient monitoring during the COVID-19 pandemic. FDA indicated that increasing the availability of these devices may increase access to important prenatal data without the need for in-clinic visits and facilitate patient management while reducing the need for in-person visits. The April 23 policy creates:
- For devices previously cleared only for use in hospitals or other health care facilities, a change to the indications or instructions regarding use in the home setting
- Modifications to devices, including changes in hardware or software, to allow for increased remote monitoring capability
- Modifications to devices to make the device more mobile for facilitating transfer into and out of a transportation vehicle and into a patient’s home.
Asynchronous (Store-and-Forward)
On April 23, FDA issued guidance to help increase availability and capability of imaging systems needed for diagnosis and treatment monitoring of lung disease in patients during the COVID-19 pandemic. These imaging products include medical x-ray, ultrasound, magnetic resonance imaging systems, and image analysis software that are used to diagnose and monitor medical conditions. FDA states that increasing the availability of mobile and portable imaging systems may increase options to image patients inside and outside of healthcare facilities, which could help to reduce the spread of COVID-19. The April 23 policy make several changes:
- Modifications to Indications, Technical Specifications, Functionality, Hardware, Software, and Materials of Imaging Systems
- Modifications to Indications and Functionality of Ultrasound Imaging Systems
- Modifications to the Indications and Functionality of Image Analysis Software
- Validation of Changes Made to Hardware, Software, Materials, or Duration of Use
- In addition, FDA recommends that the products described above include labeling that helps users better understand the product modifications
- Clinical Decision Support Software for Imaging related to COVID-19 and Co-existing Conditions
- Policy to Help Increase Availability and Minimize Supply Chain Disruptions
Guidance from the HHS Office for Civil Rights (OCR) on the Health Insurance Portability and Accountability Act (HIPAA)
HHS OCR is responsible for enforcing certain regulations issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act, to protect the privacy and security of protected health information. HHS OCR recognizes that during the COVID-19 national emergency, covered health care providers subject to HIPAA Rules may seek to communicate with patients and provide telehealth services through remote communications technologies. These technologies may not comply with the requirements of the HIPAA Rules.
In response to the rapid expansion of telehealth and the need to communicate with patients, OCR issued a “Notification of Enforcement Discretion” for telehealth remote communications during the public health emergency. It clarifies the ability of telehealth to be delivered through platforms such as Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype, without risk that OCR might seek to raise HIPAA compliance concerns.
Guidance on Clinical Laboratories
CMS issued a memo to laboratory surveyors to provide guidance on the review of pathology slides, proficiency testing, alternate collection devices, and requirements for a Clinical Laboratory Improvement Amendment (CLIA) certificate during the COVID-19 public health emergency. Recognizing the urgency of the public health emergency and the need to promote innovative uses
of technology to increase capacity and avoid exposure risks, CMS is exercising enforcement discretion to ensure pathologists may review pathology slides remotely.
Medicaid Guidance Documents During the COVID-19 Pandemic
Medicaid Guidance from the Centers for Medicare and Medicaid Services
For purposes of Medicaid, telemedicine seeks to improve a patient’s health by permitting two-way, real-time interactive communication between the patient, and the physician or practitioner at the distant site. This electronic communication means the use of interactive telecommunications equipment that includes, at a minimum, audio and video equipment.
Reimbursement for Medicaid covered services, including those with telemedicine applications, must satisfy federal requirements of efficiency, economy, and quality of care. States are encouraged to use the flexibility inherent in federal law to create innovative payment methodologies for services that incorporate telemedicine technology. For example, states may reimburse the physician or other licensed practitioner at the distant site and reimburse a facility fee to the originating site. States can also reimburse any additional costs such as technical support, transmission charges, and equipment. These add-on costs can be incorporated into the fee-for-service rates or separately reimbursed as an administrative cost by the state. If they are separately billed and reimbursed, the costs must be linked to a covered Medicaid service.
CMS continues to issue and update guidance for states seeking to expand telehealth for Medicaid in response to the COVID-19 public health emergency. It is important to note that this guidance does not create new policy, but reminds states about the flexibility that exists in the Medicaid program. While Medicaid is jointly funded by federal and state governments, states have flexibility in designing and administering their program. This flexibility has created a great deal of variation in telehealth laws and reimbursement policies.
Recent federal guidance on teleheath in Medicaid:
- FAQs for State Medicaid Agencies and CHIP Agencies – Updated May 5
- Telehealth Toolkit to Accelerate State Use of Telehealth in Medicaid and CHIP – Updated December 6
- April 2 Rural Health Medicaid Telehealth Flexibilities and Medicaid SUD Treatment via Telehealth Guidance
- March 17 Medicaid Telehealth Guidance
- General Medicaid Telehealth Guidance
Please note that the Alliance has several pages devoted to state policy that may be relevant to Medicaid, including:
State Medicaid Telehealth Waivers & Temporary Flexibilities During COVID-19
The Alliance compiled a 50-state chart of Medicaid telehealth waivers and temporary flexibilities during COVID-19. For more information on Medicaid during the COVID-19 PHE please see our Medicaid Guidance Documents During the COVID-19 Pandemic.
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