Findings and Recommendations:
Patient Safety and Program Integrity

Patient Safety Findings

The goal for patient safety in a telehealth or in-person care encounter is the same. Care provided must not result in preventable patient harm or mortality. Telehealth patient safety includes ensuring access for patient with technology or digital literacy gaps. When a patient safety metric already exists for in-person care and is applicable to telehealth, apply it rather than create additional telehealth-specific metrics.

The Agency for Healthcare Research and Quality (AHRQ) recently released an issue brief that cited studies on telehealth and patient safety.¹ Among the findings were:

• The evidence-base for telehealth is strong, especially for the remote management of chronic health conditions.²
• Systematic reviews confirm that telehealth improves health outcomes, utilization, and cost of care for a host of chronic diseases, including heart failure, diabetes, depression, obesity, asthma, and mental health conditions.^{3, 4, 5}
• For nonurgent complaints in primary care settings, diagnostic accuracy and the likelihood of diagnostic error appear to be roughly comparable in tele-diagnosis versus face-to-face encounters.^{6, 7}

The TTP did not achieve full consensus on all recommendations. For example, we found strong, but not unanimous, support for permanently lifting all controlled substance prescribing restrictions in telehealth. The public comments we received included anecdotal feedback suggesting that telehealth improved access, uptake and outcomes for behavioral health for which controlled substances are often prescribed, such as medication assisted therapy for substance use disorder. This is reflected in the related recommendations below.

Patient Safety Recommendations

1. Policymakers, in partnership with clinical subject matter experts, should identify and recommend minimum standards for assessing and ensuring patient safety via telehealth care delivery and integrate them into existing safety standards.
2. Policymakers should integrate patient safety standards for in-person and telehealth care across health policy, adapting and supplementing existing safety standards, if needed. Policymakers should not layer new telehealth policies on top of existing in-person care regulations.
   1. For example, there may be a need for standards to alert a telehealth patient that they need to seek in-person care, or to help a patient or their caregiver self-administer tests or perform other medical tasks.
   2. Integrated patient safety standards should align with quality standards across healthcare policies given the close relationship between safety and quality.
3. Congress should continue funding the research efforts of AHRQ and other organizations to identify what works–or what does not–in advancing telehealth patient safety, and should support development of best practices for telehealth as it does for other care sites.
4. AHRQ should clarify how to aggregate and analyze patient safety data to better identify improvement opportunities and publish research on telehealth encounter safety. For example, AHRQ could develop best practices and guidelines on optimizing patient safety in a telehealth encounter, as well as guidelines on safely transitioning to an in-person visit or a higher level of care.
5. Policymakers should update existing policy for in-person-care-related adverse patient safety events to incorporate telehealth, including collecting necessary information and data, as well as leveraging existing patient safety event reporting structures and the work of Patient Safety Organizations (PSO).
   1. Integration of PSO patient safety event reporting could ensure the collection of standardized data on patient safety events in a telehealth encounter that results in serious injury or death.
6. Policymakers should carefully evaluate the experience of allowing prescription of controlled substances via telehealth during the pandemic, particularly for medication-assisted treatment of substance abuse disorders, and how continuing this policy can be done in a manner that protects patient safety and prevents overprescribing or abuse. This should include consideration of:
   1. How prescribing controlled substances in a telehealth encounter can comply with regulations and enforcement currently applied to in-person prescribing.
   2. The burden for compliance should be no greater than compliance with the same rules for in-person care.
   3. How policies should align with SUPPORT for Patients and Communities Act requirements for Medicare Advantage plans to use e-prescribing for controlled substances starting in January 2021.⁸
   4. How existing and emerging technologies , such as artificial intelligence and machine learning, may have potential to help detect and mitigate fraud and abuse.

“When we’re thinking about program integrity, we need to be thinking about patient safety, it’s not just fraud and abuse. It’s also the patient at the core and we want to make sure that what we’re doing is safe and has value.” Kate Berry, Senior Vice President of Clinical Innovation, America’s Health Insurance Plans

Program Integrity Findings

While it is undoubtedly important to vigorously protect against fraud, waste and abuse (FWA) throughout healthcare, including in telehealth, arbitrary telehealth restrictions are not a justifiable or viable program integrity strategy. Arbitrary restrictions will not deter unscrupulous actors who will continue to engage in long-standing fraud schemes associated with medical equipment, opioids, compounding pharmacies and other areas.

The most effective approach to aggressively fighting FWA for both in-person and telehealth care is to leverage sophisticated technology tools that can enhance existing program integrity enforcement efforts, and to drive better collaboration with healthcare stakeholders.

In crafting our recommendations, we considered common types of FWA that can occur during an in-person patient visit, including claims for medically unnecessary care, billing for services that were never delivered, illegal kickbacks, and inappropriately coded claims. Policymakers can aggressively mitigate FWA risk in all these common types through adoption of TTP recommendations regardless of modality.

Program Integrity Recommendations

1. Congress should direct and fund enforcement agencies to harness available and emerging technologies. As part of their anti-fraud efforts, federal and state governments should foster the development of strategies that can help prevent abuse by using sophisticated analytic and artificial intelligence tools that can detect fraudulent behavior, and audit claims on the back end to uncover aberrations, for example. Telehealth enables payers to monitor IP addresses, date/time and other digital signatures to help identify bad actors. This may facilitate fraud detection and eliminate the need to physically check in-person locations and patients.

1. 1. Under the Health Care Fraud and Abuse Control (HCFAC) program, the HHS Inspector General (IG) and CMS have extensive program integrity policies and procedures in-place to address FWA and improper payments. HHS should invest in innovative enforcement strategies, employ private sector best practices and leverage predictive analytic methods and emerging artificial intelligence and predictive analytics to fight FWA in telehealth.
   2. The agencies tasked with protecting Medicare, other health programs, and ultimately patients and taxpayers must be appropriately resourced to maximize and incorporate technologies and strategies to uncover aberrations through claims audits and enhance investigations with digital forensics tools.
   3. These actions may improve the ability to detect fraud, waste and abuse, and could potentially lower telehealth program integrity risks below the amount seen with in-person care.
   4. Policymakers must protect patient privacy in every telehealth FWA mitigation effort.
2. Congress does not currently need to create new programs to address telehealth FWA, but instead should require HHS to integrate telehealth into existing FWA efforts.

1. 1. HHS should ensure coordinated, efficient and effective enforcement within and across HCFAC, the IG, the CMS Center for Program Integrity, CMS contractors such as Zone Program Integrity Contractors, Medicaid Fraud Control Units, and the Federal Bureau of Investigations.
   2. HHS should ensure that these groups continue to develop and enhance telehealth FWA detection and mitigation strategies beyond telemarketing-oriented durable medical equipment fraud and integrate such efforts with in-person and existing HCFAC workstreams.
   3. HHS should provide guidance on the application of newly integrated policies to help payers, clinicians and other providers understand and comply. HHS should partner with the Medicare Learning Network and private sector stakeholders to maximize the effectiveness of this education.
2. Since previous IG fraud reports related to telehealth making it easier to commit traditional fraud, HHS should closely monitor this and examine further ways to deter traditional fraud if there is evidence telehealth accelerates it, especially in light of known experience with issues like durable medical equipment.