April 06, 2020

FCC Launches Telehealth Initiatives for COVID-19 (and Beyond): Guidance for Health Care Providers

The Coronavirus Aid, Relief, and Economic Security (CARES) Act provides $200 million for the Federal Communications Commission (FCC) to support health care providers (HCP) in the ongoing COVID-19 pandemic. On April 2, 2020, the FCC issued an Order establishing a COVID-19 Telehealth Program designed to help HCPs maximize their provision of connected care services during the pandemic. In the same Order, the FCC also voted to go forward with its long-awaited $100 million “Connected Care Pilot Program,” several aspects of which we have discussed previously. These Q&As provide high-level background and perspective on how eligible HCPs can apply for financial assistance to promote connected care under these two distinct FCC telehealth programs.    

Q: Who Is Eligible to Participate in Both Programs? 

The funding under both Programs is to be directed solely to eligible nonprofit or public rural and non-rural HCPs that fall within these categories (this definition is taken straight from the FCC’s governing statute):

  1. post-secondary educational institutions offering health care instruction, teaching hospitals and medical schools.
  2. community health centers or health centers providing health care to migrants.
  3. local health departments or agencies.
  4. community mental health centers.
  5. not-for-profit hospitals.
  6. rural health clinics.
  7. skilled nursing facilities.
  8. consortia of HCPs consisting of one or more entities falling into the first seven categories.

Q: What Qualifies as “Connected Care” Supported in Both Programs?

The FCC broadly defines “connected care services” as a subset of telehealth that uses broadband internet access service-enabled technologies to deliver remote medical, diagnostic, patient-centered and treatment-related services directly to patients outside of traditional brick and mortar medical facilities — including to patients at their mobile location or residence. Examples include remote patient monitoring (e.g., use of patient reporting outcome platforms, glucometers, pulse oximeters, sphygmomanometers, chest straps, wearables, passive sensors, or other devices to consistently monitor patient vitals), patient health education, store and forward services (e.g., asynchronous transfer of patient images and data for interpretation by a physician), and synchronous video consultations and visits.

Q: What Is the COVID-19 Telehealth Program?

As reflected in the CARES Act, connected care services can help contain and treat other health conditions during normal times, as well as during public health emergencies. One important benefit of telehealth in current circumstances is that it enables HCPs to treat patients while maintaining physical separation, thereby helping to minimize the risk of further transmission. There are costs to providing this care, including having mobile communications capabilities, HCP internal capacity and end user devices capable of diagnostic measurement. 

The FCC’s COVID-19 Telehealth Program is meant to complement the work of other agencies in reducing barriers to telehealth services in response to the COVID-19 pandemic. For example, on March 17, 2020, the Centers for Medicare and Medicaid Services (CMS) announced relaxation of telehealth restrictions on Medicare to allow program funds to be spent on telehealth services to broaden the number of patients who can be treated and reduce the need for sick patients to travel. The relaxed rules extend treatment to patients’ homes, and do not limit the relief only to patients in remote areas. The Department of Health and Human Services (HHS) also announced that it will waive potential penalties for inadvertent and good faith violations of the HIPAA, to encourage HCPs to use telehealth services. HHS further encouraged the broader use of telehealth by notifying HCPs that they do not need to collect the usually required co-pays for patients receiving health care from an HHS program.  HHS also recently awarded $100 million to 1,381 health centers funded through the Health Resources and Services Administration (HRSA) “to address screening and testing needs, acquire medical supplies and boost telehealth capacity” in response to the pandemic.

Q: For Which Types of Services Can the COVID-19 Telehealth Program Funding Be Used?

The funding is only available to eligible HCPs for the purchase of telecommunications services, information services, and devices necessary for them to provide “connected care services.”

Notably, the COVID-19 Telehealth Program will only fund monitoring devices (e.g., pulse-ox, BP monitoring devices) that are themselves connected, but not unconnected devices that patients can use at home and then share the results with their medical professional remotely.

Moreover, this Program will not provide funding for HCP administrative costs associated with participating in the COVID-19 Telehealth Program (e.g., costs associated with completing Program applications and other FCC submissions) or other miscellaneous expenses (e.g., doctor and staff time spent on the COVID-19 Telehealth Program and outreach). The costs of ineligible items may not be included in any reimbursement requests for the COVID-19 Telehealth Program. To guard against potential waste, fraud and abuse, the FCC’s Order states that participating HCPs are prohibited from selling, reselling or transferring services or devices funded through the COVID-19 Telehealth Program in consideration for money or any other thing of value.   

Q: How Will the FCC Evaluate COVID-19 Telehealth Program Applications? 

The FCC’s Wireline Competition Bureau will review applications in consultation with the FCC’s Connect2Health Task Force and its medical and public health experts. The FCC expressed a strong interest in targeting funding towards areas that have been hardest hit by COVID-19. No funding preference will be given for specific medical conditions, patient populations, or geographic areas. However, the FCC strongly encourages applicants to target funding to high-risk and vulnerable patients to the extent that is practicable.

To the extent HCPs may be operating under preexisting strain (e.g., large underserved or low-income patient population; health worker shortages; rural hospital closures; limited broadband access and/or internet adoption), the FCC encourages applicants to document these factors in their applications. Funding is not limited to treating patients that have COVID-19, as long as program funds are used “to prevent, prepare for, and respond to coronavirus,” as stated in the CARES Act. 

For instance, treating other types of conditions or patient groups may free up resources and allow HCPs to remotely treat patients with other conditions who could risk contracting coronavirus by visiting a health care facility. This also could reduce health workers’ unnecessary exposure to coronavirus. As part of an application, for example, an HCP might show that telemedicine directly aids in the prevention of pandemic spread by facilitating social distancing and similar measures in the community. However, funding sought for connected devices and services like patient-reported outcome platforms funded through the Program must be integral to patient care. 

Any award of support is to be based on the estimated costs of the supported services and connected devices the applicant intends to purchase, as described in each HCP’s respective application. However, in order to provide maximum flexibility to respond to changing circumstances during the pandemic, the FCC will not require applicants to purchase only the services and connected devices identified in their applications. Rather, they may use awarded support to purchase any necessary eligible services and connected devices.

Q: When Will the COVID-19 Telehealth Program Start? 

The FCC will begin accepting applications immediately after publication of its Report and Order and notice of the Office of Management and Budget’s (OMB) approval of the COVID-19 Telehealth Program’s information collection requirements in the Federal Register.  The FCC’s Wireline Competition Bureau will review the applications as they are received, select participants, announce funding amounts, and make funding awards as rapidly as possible on a rolling basis.

Q: Is There a Limit to the Amount of Funding HCP Participants Can Receive Under the COVID-19 Telehealth Program?

Not explicitly. The COVID-19 Telehealth Program will provide selected applicants full funding for eligible services and devices using the congressionally appropriated $200 million budget, which will be available until the funds are expended or until the pandemic ends. The FCC does not anticipate awarding more than $1 million to any single applicant. Applicants that have exhausted any initially awarded funding may request additional support and could potentially receive it, but only if funding remains available and the further application is approved by FCC staff.

Q: Are HCPs Required to Procure Program-Supported Services and Equipment Through Competitive Bidding Processes? 

No. Given the urgent need to award and disburse the COVID-19 Telehealth Program funding, the FCC will not require Program participants to conduct a competitive bidding process to solicit and select eligible services or devices. These requirements would cause unnecessary delays and pose an unreasonable burden during this unprecedented time. The FCC Order also finds that it would not be in the public interest during this crisis to prohibit participating HCPs from receiving gifts or things of value from service providers valued at over $20, including, but not limited to devices, equipment, free upgrades or other items. 

The FCC committed to guard against waste, fraud and abuse in the Program. Thus, applicants are encouraged to purchase cost-effective eligible services and devices. Participants must maintain records related to their participation in the COVID-19 Telehealth Program to demonstrate their compliance with Program requirements for at least three years from the last date of service and must present that information to the FCC upon request.  Participants may also be subject to compliance audits and must provide documentation related to their participation in the COVID-19 Telehealth Program in connection with any such audit. 

Q: Will the FCC Issue Further Rules Regarding the COVID-19 Telehealth Program?

Yes. The FCC will develop processes for selected applicants to submit invoices and receive reimbursement for services and devices supported through the COVID-19 Telehealth Program, as well as any necessary subsequent filings, such as post-program assessment. 

Q: Can Eligible HCPs Participate in Both Programs?

Yes. Applicants who are selected for the COVID-19 Telehealth Program may later submit applications to participate in the Connected Care Pilot Program. However, they may not request funding from the FCC for the same exact services from both programs at the same time.

Q: How Did the Connected Care Pilot Program Change Since the Notice of Proposed Rulemaking?

In the Order, the FCC relaxed some of its more prescriptive proposed rules and procedures to adopt something that embraces more flexibility in terms of allowing HCPs to design their preferred Connected Care Pilots for experimentation. Most notably, the FCC will consider supporting store-and-forward information services and some network equipment in the context of granted applications in the Connected Care Pilot Program. What has not changed is that the Program will run for three years and provide an 85% discount on supported services and equipment.

Q: When Are the Connected Care Pilot Program Applications Due? 

The deadline for filing applications for the Pilot Program will be 75 days from the publication of the Pilot Program rules in the Federal Register, or 120 days from the release date of the Order, whichever is later. FCC review of the applications and its selection of applicants will be guided by criteria outlined in the Order.

Q: How Will the FCC Evaluate Connected Care Applications? 

The FCC expressed a strong interest in targeting limited Pilot Program resources towards patient populations, health conditions and geographic areas where funding for connected care services, in its judgment, is most needed. Specifically, the FCC intends to target funding towards projects that would primarily benefit low-income or veteran patients. 

The funding would also favor pilot projects that are primarily focused on treating public health epidemics, opioid dependency, mental health conditions, high-risk pregnancy, or chronic or recurring conditions that typically require at least several months to treat, including diabetes, cancer, kidney disease, heart disease, and stroke recovery. By focusing on the types of health conditions that affect large segments of the population, often require several months or more of treatment, and/or are considered public health crises, the FCC expected the Pilot Program to provide more meaningful data to track progress towards the goals of helping HCPs improve health outcomes and reduce costs.

he FCC also expressed a strong preference for HCPs that have either (1) experience with providing telehealth or connected care services to patients (e.g., remote patient monitoring, store-and-forward imaging, or video conferencing) beyond using electronic health records, or (2) a partnership with another HCP, government agency, or designated telehealth resource center with such experience that will work with the HCP to implement its proposed pilot project.

Applicants must describe, among other things, the proposed pilot project and how the pilot project will use connected care services to serve the needs of participating patients. Eligible HCPs will be provided flexibility to design their proposed pilot projects, select the service providers for the supported services and network equipment, and identify and enroll qualifying, participating patients. However, participating patients may only participate in one pilot project and cannot participate in multiple pilot projects as part of this Program. 

Q: Is There a Limit to the Amount of Funding That Each Pilot Project Can Receive?

Not explicitly. The FCC will not set a limit on the number of pilot projects selected for funding or limit the amount of support requested per pilot project. In part this is because limiting the amount of support requested per pilot project before evaluation and selection was viewed as arbitrarily limiting the scope of potential projects and the data to be collected. The FCC declined per-project funding limits in the interest of maximizing flexibility to select a diverse group of pilot projects as well as to enhance focus on selecting quality pilot projects that can provide meaningful data. The agency will be mindful, however, of the total Pilot Program budget and the funding needs of each pilot project when selecting projects to ensure that each project will have enough financial support to be successful. For example, the FCC Order states that the agency does not anticipate allocating all of the Pilot Program funds to only one or two large projects. 

Q: For Which Types of Services Can the Connected Care Pilot Program Funding Be Used?

HCPs that participate in the Pilot Program can receive support for qualifying broadband service from any broadband provider, regardless of whether that provider is designated as an eligible telecommunications carrier (ETC). The Pilot Program funding can be used to defray the following costs of providing connected care services: (1) patient broadband Internet access services, (2) HCP broadband data connections, (3) other connected care information services, and (4) certain network equipment (e.g., routers and servers) necessary to make a supported service functional and for consortium applicants to fund network equipment necessary to manage, control, or maintain a supported broadband service. 

HCPs may not receive funding for network equipment for which they already applied or received funding through the FCC’s Healthcare Connect Fund Program or another federal program. HCPs are also prohibited from using FCC universal service funds to purchase equipment or services for use through the Pilot Program that are produced or provided by a company that the FCC has identified as posing a national security threat to the integrity of communications networks or the communications supply chain (ZTE or Huawei). Further, unlike the COVID 19 Telehealth Program, the Pilot Program will not fund end-user diagnostic devices or equipment, HCP administrative costs associated with participating in the Pilot Program (e.g., costs associated with completing Pilot Program applications and other submissions), or other miscellaneous expenses (e.g., doctor and staff time spent on the Pilot Program and outreach). 

Q: Will the FCC Issue Further Rules Regarding the Connected Care Pilot Program?

Yes. The FCC will issue further rules on the requirements for requesting funding, invoicing, data reporting, and programmatic safeguards including document retention and audit requirements. 

Next Steps for Eligible Health Care Providers

As many HCPs in need of funding from the expedited COVID-19 Telehealth Program to face the fast-evolving public health crisis, interested and eligible HCPs that can make good use of the funding should act to gather information needed to obtain a needed eligibility determination, to substantiate funding requests and to satisfy other administrative requirements (such as certification or reporting) that are not part of this summary. The Faegre Drinker team is closely monitoring this proceeding and would be happy to provide additional information upon request. 

As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.

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