public health emergency Archives - OF DIGITAL INTEREST

public health emergency

2024: The Year of the Telehealth Cliff

by Lisa Mazur, Rachel Stauffer, Debra Curtis and Leigh Feldman | Jan 12, 2024 | Telehealth

What does December 31, 2024, mean to you? New Year’s Eve? Post-2024 election? Too far away to know?

Our answer: December 31, 2024, is when we will go over a “telehealth cliff” if Congress fails to act before that date, directly impacting care and access for Medicare beneficiaries. What is this telehealth cliff? Let’s back up a bit.

TELEHEALTH COVERAGE POLICIES

Current statute (1834(m) of the Social Security Act) lays out payment and coverage policies for Medicare telehealth services. As written, the provisions significantly limit Medicare providers’—and therefore patients’—ability to utilize telehealth services. Some examples:

If the patient is in their home when the telehealth service is being provided, telehealth is generally not eligible for reimbursement.
Providers cannot bill for telehealth services provided via audio-only communication.
There is a narrow list of providers who are eligible to seek reimbursement for telehealth services.

COVID-19-RELATED TELEHEALTH FLEXIBILITIES

When the COVID-19 pandemic hit in 2020, a public health emergency (PHE) was declared. Congress passed several laws, and the administration acted through its own authorities to provide flexibilities around these Medicare telehealth restrictions. In general, nearly all statutory limitations on telehealth were lifted during the PHE. As we all know, utilization of telehealth skyrocketed.

The PHE ended last year, and through subsequent congressional efforts and regulatory actions by the Centers for Medicare and Medicaid Services (CMS), many flexibilities were extended beyond the end of the PHE, through December 31, 2024. Congress and CMS continue to grapple with how to support the provision of Medicare telehealth services for the future.

CMS has taken steps through the annual payment rule, the Medicare Physician Fee Schedule (MPFS), to align many of the payment and coverage policies for which it has regulatory authority with congressional deadlines. CMS has also restructured its telehealth list, giving more clarity to stakeholders and Congress as to which pandemic-era telehealth services could continue if an extension is passed. But CMS can’t address the statutory limitations on its own. Congress must legislate. CMS highlighted this in the final calendar year (CY) 2024 MPFS rule released on November 2, 2023, noting that “while the CAA, 2023, does extend certain COVID-19 PHE flexibilities, including allowing the beneficiary’s home to serve as an originating site, such flexibilities are only extended through the end of CY 2024.”

THE TELEHEALTH CLIFF

This brings us to the telehealth cliff. CMS generally releases the annual MPFS proposed rule in July, with the final rule coming on or around November 1. If history is any indication, Congress is not likely to act on the extensions much before the current December 31 deadline. This sets up the potential for a high level of uncertainty headed into 2025.

If we go over, this telehealth cliff would directly impact care and access for Medicare beneficiaries. The effects could be felt acutely in rural and underserved areas, where patients have been able to access, via telehealth, medical services that may have been out of reach for them in the past. The telehealth cliff would [...]

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Teleprescribing of Controlled Substances Temporarily Extended Beyond PHE – What’s Next?

by McDermott Will & Emery | May 10, 2023 | Telehealth

The US Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) are extending telehealth flexibilities that allow providers to prescribe controlled substances. While the extension is in place, the DEA indicated that, in light of the 38,000 comments it has received, it will be further evaluating its recently proposed rules for post-PHE telemedicine prescription of controlled substances. Learn what stakeholders need to monitor during this time and what may be next from the DEA.

Read the On the Subject here.

Preparing Your Data for a Post-COVID-19 World

by Stephen W. Bernstein, Bernadette M. Broccolo and Scott Weinstein | Jul 30, 2020 | Big Data, Data Transfers/Safe Harbor/Privacy Shield

The US healthcare system’s data infrastructure needs an overhaul to prepare for future health crises, streamline patient care, improve data sharing and accessibility among patients, providers and government entities, and move toward the delivery of coordinated care. With insights from leaders from Arcadia, Validic and McDermott, we recently discussed key analyses and updates on the interoperability and application programming interfaces (API) criteria from the 21st Century Cures Act, stakeholder benefits of healthcare data exchange and data submission facilitation for public health purposes. Click here to listen to the webinar recording, and read on for highlights from the program.

To learn more about the “Around the Corner” webinar series and attend an upcoming program, click here.

PROGRAM INSIGHTS

COVID-19 is reshaping healthcare through technology. Hospitals, clinicians and payors need to use digital health tools to address the challenges of the coronavirus (COVID-19) public health pandemic. How COVID-19 data and health information are captured, and then move through electronic systems, will form the foundation by which digital health tools can become effective in identifying cases, treating them and ensuring favorable outcomes.
API certification requirements under the 21st Century Cures Act are designed to enhance the accessibility of electronic health information. The 21st Century Cures Act’s purpose is to advance interoperability, address information blocking, support seamless exchange of electronic health information and promote patient access. Putting data from electronic health records (EHRs) into patients’ hands through consumer-facing apps will empower them to understand and take control of their health.
EHR vendors will be required to offer APIs that comply with the Fast Healthcare Interoperability Resource (FHIR) standard by May 1, 2022. The 21st Century Cures Act Final Rule will require EHR vendors to offer FHIR based APIs that make electronic health information more readily available to third-party applications (apps) of patients’ and providers’ choosing. API standardization will make it easier for third-party developers to build these apps, and for patients and providers wishing to use third-party apps to leverage their electronic health information for various purposes, including health information exchange and population health management.

Interoperability refers to the standards that make it possible for different EHR systems to exchange patient medical records and information between providers. Increased interoperability between EHR systems using harmonized standards allows for a more seamless transfer of patient data between providers. The interoperability requirements in the 21st Century Cures Act have the potential to advance patient access to their data and the use of information among physicians.
Both providers and patients can drive data exchange. One challenge impacting data exchange between patients and providers is that providers cannot always access or integrate data that patients have created with third-party tools (e.g., fitness trackers). However, there is emerging technology designed to aggregate and standardize consumer-generated health information, [...]

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The Role of Telehealth in COVID-19 Response Efforts

by Dale C. Van Demark, Lisa Mazur and Marshall E. Jackson, Jr. | Mar 3, 2020 | Telehealth

As the number of confirmed COVID-19 cases in the United States grows, healthcare providers are stepping up their response planning. To combat the spread of COVID-19, the Centers for Disease Control and Prevention (CDC) urged healthcare systems and providers to deploy all of the resources necessary to ensure health system preparedness. The CDC recommended the use of telehealth tools to help address COVID-19 preparedness and to assist in directing patients to the right level of healthcare for their medical needs.

Healthcare providers have a unique and pressing opportunity to offer telehealth services to potential COVID-19 patients. At the same time, healthcare providers’ response to the COVID-19 outbreak highlights some of the barriers to the provision of telehealth services. Providers considering using telehealth as part of their COVID-19 response efforts should take the following factors into consideration:

While healthcare providers cannot diagnose COVID-19 through a telehealth visit, they can perform a number of services without requiring a patient to visit crowded medical facilities where the virus might be present. These services include performing initial patient screenings, assessing and assigning risk categories to patients, determining if a patient needs to seek diagnostic testing, and answering patient questions and offering treatment recommendations.
Deploying telehealth services is not without its challenges. The varying reimbursement policies of private, state and federal payers, as well as differing state-based medical licensing requirements, may burden providers and patients with confusion, economic inefficiencies and onerous processes in a difficult engagement context.
As part of the COVID-19 response discussions, telehealth advocates propose that the Centers for Medicare and Medicaid Services reduce or eliminate its long-standing telehealth reimbursement restrictions. This change would allow Medicare to pay for virtual visits during national emergencies, regardless of originating site or geographic location. There is also a push to waive the lengthy enrollment process telehealth providers must undergo to be paid by Medicare.
While telehealth has the potential to assist in a healthcare system’s response to COVID-19, providers still must comply with state laws and regulations that govern telehealth, including but not limited to professional licensure, scope of practice, standard of care and patient consent, in addition to the reimbursement requirements and limitations put into place by third-party payers.
- Typically, telehealth providers must be licensed in the state in which the patient is located, although certain states have exceptions that telehealth providers may leverage in response to COVID-19.
- Telehealth providers must practice within the scope of practice of the profession in which they are licensed and within the standard of care set forth by the governing professional board in a given state.
- State telehealth laws may require a specific modality for telehealth consultations (e.g., audio-visual consultations). Likewise, third-party payers may require a specific modality for telehealth consultations for purposes of reimbursement.

Declaration of Public Health Emergency Changes Remote Prescribing Requirements but Creates Many Questions Waiting to Be Answered

by McDermott Will & Emery, Lisa Mazur and Marshall E. Jackson, Jr. | Oct 26, 2017 | General Interest, Telehealth

President Trump declared the opioid addiction epidemic a public health emergency yesterday. The White House made it clear that this declaration would allow officials to remove barriers to the prescribing of controlled substances via telemedicine, which would permit DEA registered providers to prescribe anti-addiction medications, such as Naloxone, to patients in need without first performing an in-person exam.

As background, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Haight Act) requires a telemedicine provider who is prescribing a controlled substance to a patient to perform an in-person medical evaluation of the patient prior to prescribing a controlled substance, unless one of the narrow telemedicine exceptions set forth in the Haight Act applies. Additional information on the Ryan Haight Act and the implications of this declaration can be found here.

There are many important questions remaining to be answered, including whether any funding will be available to support the implementation of this declaration and whether the declaration will be renewed upon its expiration in 90 days. The answers to these questions are important to healthcare providers who will need to invest resources and time into developing telemedicine programs to reach more substance use disorder patients, which may take longer than 90 days to implement.