Introduction to Telehealth
According to the National Rural Health Association, fewer than 10% of U.S. physicians practice in rural communities, where 25% of Americans live. Yet, rural Americans may need more health care as they become increasingly older and sicker relative to their urban counterparts. Telemedicine is transforming health care from a service solely delivered through traditional brick-and-mortar health care facilities to a variety of connected care options that can be delivered directly to the patient wherever they are (with a broadband internet connection). Telehealth has been proposed as a solution to improve access to care and is expected to create significant cost savings for chronic care disease management, which accounts for over 85% of direct health care spending in the U.S. Federal and state policymakers have enacted policies to expand the use of telehealth among publicly and commercially insured beneficiaries. While the trend is growing, many health care providers and patients have not yet adopted connected care services.
Earlier this year, the Centers for Medicare and Medicaid Services (CMS) published a final rule that will expand access to telehealth services for Medicare Advantage (MA) plan enrollees. This rule allows MA plans to choose to offer a broader scope of telehealth services under the basic Medicare benefits (original Medicare benefits) as opposed to only allowing them as supplemental benefits. It is CMS’ hope that MA plans will elect to cover these expanded services as they will be able to fund them out of their government capitation rates as opposed to their supplemental premiums.
CMS has also encouraged state Medicaid programs to utilize telehealth as a means of combating the opioid epidemic. In 2018, the agency urged Medicaid program directors and providers to take advantage of connected care technology that connects them with patients outside the office or hospital and allows them to monitor care management.
Finally, in May 2018, the U.S. Food and Drug Administration (FDA) launched an effort to bring connected health technologies to fight the opioid crisis. The FDA’s challenge sought mHealth technology in any stage of development, including diagnostic tools and treatments. A team from the FDA’s Center for Devices and Radiological Health granted applicants that met the challenge criteria Breakthrough Device designation which offers FDA applicants enhanced access to FDA experts and priority review of submissions for FDA approval.
Barriers to Adoption of Telehealth Technologies
While federal and state policymakers have enacted these and other policies to expand telehealth technologies and use among publicly and commercially insured beneficiaries, three primary issues continue to be cited as barriers to adoption by providers and researchers:
Reimbursement issues and health care professional licensing laws and regulations
Lack of residential broadband Internet access
Cost of connected care services, including broadband connectivity costs
The Federal Communications Commission (FCC)’s Universal Service Fund has two established Rural Health Care (RHC) programs that provide funding to help defray the cost of broadband connectivity for health care providers. This historical focus on supporting telecommunications at provider locations does not align with the current trend in telehealth of connecting with patients directly at their location. Researchers have found that Americans with the poorest access to care often do not have the necessary broadband Internet capability (sufficient bandwidth) to fully benefit from telemedicine. Other researchers used FCC data to measure broadband Internet access and found that broadband penetration rates decreased as counties became more rural, and that counties with inadequate access to primary care physicians and/or psychiatrists generally had poorer broadband penetration rates. Their findings revealed that, “although telemedicine has the potential to address geographic barriers that result from long drive times to receive care, its potential will not be realized until the telecommunications infrastructure improves and public and commercial insurers develop and expand policies to reimburse telemedicine visits from patients' homes, particularly in the most rural counties.”
To address this barrier to the adoption of telehealth, on July 10, 2019, the FCC voted unanimously to establish a three-year $100,000,000 Connected Care Pilot program that would support bringing telehealth services directly to areas lacking adequate healthcare and to underserved populations including low-income patients and veterans. The Connected Care Pilot would use the FCC's Universal Service Fund to provide an 85% discount on connectivity for broadband-enabled telehealth services that connect patients directly to their doctors and are used to treat a wide range of health conditions. Data from the Pilot program would be used to analyze the possible benefits that support of broadband service for connected care may bring to expanding access, reducing costs, and improving outcomes.
The Notice of Proposed Rulemaking (NPRM) adopted by the Commission seeks comment on specific components of the Pilot program including: the appropriate budget, duration, and structure of the Pilot as well as other issues discussed further below. This article summarizes some of the key programmatic elements that health care providers, associations, and other stakeholders are being asked to provide comment on by the FCC. While this targeted Pilot may not align with the population that a provider or organization typically serves, it is important for all stakeholders to understand that how the FCC defines terms and programmatic policy may impact how other Federal agencies, and potentially states, develop programs and policies related to telemedicine and telehealth. A consistent and integrated approach to state and federal law and policy that benefits all parties will ultimately reduce administrative burden, improve adoption, and increase efficiencies across all telehealth programs.
Key Programmatic Elements Up For Comment
The FCC proposes to implement a flexible program that gives health care providers some latitude to determine specific health conditions and geographic areas that will be the focus of the proposed projects. However, the NPRM proposes to limit the Pilot to projects that primarily focus on health conditions that typically require at least several months or more to treat such as behavioral health, opioid dependency, chronic health conditions, and high-risk pregnancies. This limitation will ensure that the data collected is meaningful and statistically significant; enabling the FCC to track health outcomes and cost savings.
Comments made on the Notice of Inquiry asserted that the Pilot should not be limited to projects that treat specific health conditions. The FCC seeks to ensure that the program funding is used for legitimate medical conditions to guard against potential waste, fraud, and abuse and therefore asks commenters:
Should a specific definition of “health conditions” be adopted for the purposes of the Pilot program?
If so, is there a generally accepted authority that provides a definition of “health condition” that would be appropriate?
The record from the Notice of Inquiry demonstrates that health care providers typically purchase broadband Internet access service that enables connected care through a broadband carrier or connected care company (for example, a remote patient monitoring company). The health care provider then provides a connected care service, including the broadband Internet access to the patient directly. The FCC seeks to understand:
To what extent are health care providers already funding patient broadband connections for connected care services?
What are the costs associated with funding those connections?
To what degree would providing universal service funding to offset these costs enable health care providers to extend service to additional patients or treat additional health conditions?
Commenters asserted that the Pilot should not be used to fund Internet connections between health care providers and the FCC concurs as that would be duplicative of the existing USF programs. Therefore, the FCC proposes to exclude provider-to-provider connections from the Pilot program.
Additionally, the FCC seeks comment on the following proposed definitions for telehealth, telemedicine, and connected care and their applicability to the Connected Care Pilot program. Respondents should consider whether there are any additional qualifiers that should be placed on the definitions to ensure that the Pilot program is focused on medical services delivered directly to patients outside of traditional medical facilities through broadband-enabled technologies. These definitions are:
Telehealth: a wide variety of remote health care services beyond the doctor-patient relationship; for example, involving services provided by nurses, pharmacists, or social workers
Telemedicine: using broadband Internet access service-enabled technologies to support the delivery of medical, diagnostic, and treatment-related services, usually by doctors
Connected Care: a subset of telehealth that is focused on delivering remote medical, diagnostic, and treatment-related services directly to patients outside of traditional brick-and-mortar facilities.
Providers are asked to provide comments on whether there are packages or suites of services that they use to provide connected care services. These may include a turnkey solution that includes software, remote patient monitoring and remote monitoring devices, and patient broadband Internet access. The questions providers are asked include:
Are such packages or suites of services available that are not currently supported by the RHC programs and should be funded by the Pilot as information services?
What types of services should be considered information services and therefore funded by the Pilot program?
How are these programs currently funded by providers and what are the typical costs?
Other Program Structure Considerations
The FCC understands that there is inconsistency in licensing and reimbursement law and regulation at the federal and state levels that may have a bearing on provider participation in the program. For example, commenters have indicated that reimbursement is a major barrier to telehealth adoption and have urged the FCC to coordinate with CMS. They, therefore, seek comment on the following to inform how they structure the Pilot program:
What are the specific laws and regulations that may impact provider participation in the Pilot and ultimately adoption of connected care (e.g., Medicare and Medicaid Anti-Kick Back Statute, the Civil Monetary Penalties Act)?
How would these laws and regulations impact the Pilot and how should the Commission design the structure of the Pilot considering those impacts (e.g., how should the Commission coordinate with CMS)?
Eligible Health Care Providers
The Commission proposes to limit Pilot participation to non-profit or public health care providers within section 254(h)(7)(B) of the Universal Service Fund authority which includes: 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; 5) rural health clinics; 6) skilled nursing facilities; and 7) consortia of health care providers consisting of one or more entities described in 1-6.
The Commission believes there is benefit in applying this limitation, as it would focus the Pilot program funding on health care providers most in need of additional funding to reach eligible patients through connected care services and provide administrative clarity and consistency across the USF programs. Additionally, the statutory definition encompasses many facilities serving medically underserved communities, including Veterans Affairs health administration facilities and facilities run by the Indian Health Service. Therefore, the Commission seeks comment as to whether:
This section of the USF code requires the Pilot be limited to the included categories of providers.
There is an interpretation of the section that would allow funding to be provided to Emergency Medical Technicians, health kiosks, and school clinics via the Pilot program.
Additionally, the NPRM proposes requiring eligible health care providers to have prior experience with telehealth and long-term patient care. Regarding this, they ask:
What steps should be taken to ensure that participating providers have significant experience with providing long-term patient care? What are potential criteria to demonstrate experience?
Should eligible providers be limited to those that have experience integrating remote monitoring and telehealth services? Should it be limited to providers that are federally designated as Telehealth Resource Centers or as Telehealth Centers of Excellence? Are there other criteria or designations?
Finally, the FCC proposes that the Pilot program be open to both urban and rural eligible health care providers. The Commission is interested in promoting geographic diversity among Pilot participants and seeks comment on the following:
We are considering limiting participation to eligible health care providers that are located in or serve an area that has received the Health Resources and Services Administration’s Health Professional Shortage Areas designation or Medically Underserved Areas designation which correlate with professional shortages and lower-income areas. Are there benefits or drawbacks to using these designations?
What are your thoughts on limiting participation to eligible health care providers that serve a minimum percentage of uninsured or underinsured patients or Medicaid patients?
Pilot Programs Goals and Metrics
It is important for providers and other stakeholders in the health care system to engage in opportunities to influence federal policy to ensure that their needs are being adequately considered. However, respondents should develop their comments broadly in light of the four primary goals that the FCC is seeking to achieve for the Connected Care Pilot program:
Improving health outcomes through connected care;
Reducing health care costs for patients, facilities, and the health care system;
Supporting the trend towards connected care everywhere; and
Determining how USF funding can positively impact existing telehealth initiatives.
The Commission seeks comment on the appropriate metrics and methodologies to measure the Pilot project’s progress towards these goals. In the Notice of Inquiry, the FCC proposed several metrics to assess improving health outcomes: reductions in emergency room or urgent care visits; decreases in hospital admissions or readmissions; condition-specific outcomes such as reductions in premature births or acute incidents among sufferers of a chronic illness; and patient satisfaction as to health status. Related to this, the Commission asked:
Are there specific ways in which broadband enabled telehealth applications can improve health outcomes that could be demonstrated through the Pilot program?
Are there other metrics for measuring this goal?
The Commission requests commenters to provide, where available, data and other information to help evaluate the potential cost savings through telehealth. They asked:
In addition to the specific areas of cost savings discussed, in what other ways can the provision of telehealth produce cost savings for patient, facilities and the health care system?
What metrics are available to measure this goal?
With decades of experience at the highest level of federal, state, and local governments, Atròmitos understands the intersection of legislation, regulation, and business. We have written and analyzed countless laws and regulations that have implemented health care programs such as the Connected Care Pilot. We can develop public comments that are backed by in-depth research and provide clear and effective feedback that government agencies can leverage to improve their program development and planning processes. We can bring all of this expertise to bear for your organization as you consider how this proposed rule and others like it may impact your organization. Visit www.atromitosconsulting.com/contactus to get in touch with us today.
 CDC, Rural Americans at higher risk of death from five leading causes
 Examples of connected care services delivered to patients at their residence or mobile location rather than a health care provider’s physical location include, but are not limited to, synchronous video consultations and visit, store and forward services, remote patient monitoring, and patient health education. Karen Schulder Rheuban & Elizabeth A. Krupinski, Understanding Telehealth 18 (1st ed. 2017)
 Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021
 CMS, State Medicaid Director Letter SMD # 18-006 RE: Leveraging Medicaid Technology to Address the Opioid Crisis
 Universal service is the principle that all Americans should have access to communications services. Universal service is also the name of a fund and the category of FCC programs and policies to implement this principle. The fund managed by the FCC and paid for by contributions from telecommunications providers.
 FierceHealthcare, Poor broadband access in rural areas limits telemedicine use: study
 Access was defined by the county-level fixed broadband penetration rate as defined by the FCC: the percentage of a county's population with Internet access at a download speed of at least 25 megabits per second, which is sufficient to support video-based telehealth visits.
 FCC Press Release, FCC Seeks Comment on Proposed $100 Million Connected Care Pilot Program
 FCC Notice of Proposed Rulemaking, FCC-CIRC1907-03