These laws temporarily relax certain Medicare restrictions by allowing healthcare providers to treat patients who are at home and by not limiting telehealth services to only those in remote areas, as was previously the case.
In the wake of the coronavirus outbreak and social-distancing mandates, the federal government enacted legislation to encourage the use of telehealth services.[1] The Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (Preparedness Act), which includes the Telehealth Services During Certain Emergency Periods Act of 2020 (Telehealth Act), was signed into law on March 6, 2020. The Coronavirus Aid, Relief and Economic Security Act (CARES Act) was signed into law on March 27, 2020.
These laws temporarily relax certain Medicare restrictions by allowing healthcare providers to treat patients who are at home and by not limiting telehealth services to only those in remote areas, as was previously the case. These laws also provide funding for telehealth grant programs through the Department of Health and Human Services (HHS) and the Federal Communications Commission (FCC). Additionally, penalties for inadvertent and good faith violations of the Health Insurance Portability and Accountability Act (HIPAA) will be waived. Healthcare providers may use popular communication systems, such as Apple FaceTime or Google Hangouts, when providing telehealth services.
Temporary Waiver and Modification of Medicare Restrictions
The HHS Secretary can temporarily waive or modify certain Medicare requirements under Section 1135 of the Social Security Act (SSA) to ensure that sufficient healthcare services are available during a disaster or emergency and that providers who furnish such services in good faith are reimbursed.
Specifically, the Telehealth Act waives the originating site requirements in Section 1834(m) of the SSA (42 U.S.C. 1395m(m)). It defines the emergency area and period to include this COVID-19 public health emergency allowing patients to receive telehealth services anywhere, including in their homes. Patients were previously unable to receive care from their homes and instead were required to travel to an originating site such as a clinic or hospital.
The Telehealth Act allows providers to use telephones with audio and video capabilities used for two-way, real time communications for the provision of telehealth services. Under federal regulations, conventional landline telephones fail to meet the definition of an interactive telecommunication system and therefore could not be used for telehealth services prior to this waiver.
Section 3704 of the CARES Act expands the term distant site in Section 1834(m) of the SSA (42 U.S.C 1395m(m)) to include federally qualified health centers (FQHCs) and rural clinics. This modification allows FQHCs and rural clinics to be reimbursed at comparable rates under Section 1834 of the SSA for providing telehealth services to Medicare patients, similar to any other distant site.
Section 3705 of the CARES Act temporarily waives the face-to-face requirement in Section 1881(b)(3)(B) of the SSA (42 U.S.C. 1395rr(b)(3)(B)), thus allowing end-stage renal patients who undergo home dialysis to receive clinical assessments via telehealth. Previously, these patients could only use telehealth for clinical assessments if they received a face-to-face assessment each month for the first three months and at least once a month every three months thereafter.
Section 3706 of the CARES Act amends Section 1814(a)(7)(D)(i) of the SSA (42 U.S.C. §1395f(a)(7)(D)(i)) by allowing a hospice physician or nurse practitioner to conduct a face-to-face encounter and hospice assessments with telehealth services. These encounters are required to determine the continued eligibility of the individual for hospice care prior to each recertification.
Section 3707 of the CARES Act requires the HHS Secretary to consider ways to encourage providers to use telehealth to provide home health services (e.g., intermittent nursing care, physical or occupation therapy and other services as defined in Section 1861(m) of the SSA (42 U.S.C. 1395x(m)) furnished by a home health agency.[2]
The Centers for Medicare & Medicaid Services (CMS) has likewise expanded telehealth with Section 1135 waivers. Under these waivers, Medicare can pay for office, hospital and other visits conducted by telehealth services for patients across the country, where previously, Medicare would only reimburse for telehealth provided to patients in a designated rural area. Patients can receive telehealth services from home rather than requiring travel to medical facilities such as clinics or hospitals to utilize telehealth, as was previously the case.
Medicare coinsurance and deductibles would generally apply to these telehealth services. The HHS Office of Inspector General (OIG) is allowing healthcare providers to reduce or waive these required cost-sharing obligations and copays for telehealth visits during the emergency period. Moreover, the HHS will not conduct audits to ensure that prior relationships necessary for certain waivers exist for claims submitted during this emergency period.
Expansion of Health Resources and Services Administration Grants
The Preparedness Act and the CARES Act provide funding to the Health Resources and Services Administration (HRSA) to respond to the coronavirus outbreak. Specifically, the Preparedness Act provides $100 million to 1,381 health centers across the country for screening, testing, acquiring medical supplies and boosting telehealth capacity. Section 3212 of the CARES Act expands the telehealth network and resource centers grant program funded by HHS under Section 3301 of the Public Health Service Act. Under these amendments:
- For-profit entities are eligible to apply for grants;
- The maximum percentage of grant monies that can be spent on equipment is 20 percent, reduced from 40 percent originally;
- The term of the grant is five years instead of the original four years; and
- There are $29 million of available grant funds for each fiscal year from 2021 through 2025.
Expansion of Federal Communications Commission Grants
The CARES Act provides $200 million in funding to the FCC to support the efforts of healthcare providers that respond to coronavirus. The FCC is distributing these funds through its COVID-19 Telehealth Program. Eligible healthcare providers can apply for support to purchase telecommunications, information services and connected devices to provide connected care services[3] in response to the coronavirus pandemic.[4]
The COVID-19 Telehealth Program is open to healthcare providers in rural and nonrural areas. Nonprofit and public eligible healthcare providers include, without limitation: (1) post-secondary educational institutions offering healthcare instruction, teaching hospitals and medical schools; (2) community health centers or health centers providing healthcare 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; or (8) consortia of healthcare providers consisting of one or more entities falling into the first seven categories.[5]
The FCC will accept applications submitted by healthcare providers on a rolling basis. To ensure as many eligible healthcare providers receive funding as possible, the FCC does not anticipate awarding more than a $1 million grant to any single applicant. Providers that have exhausted initially awarded funding may request additional support.
Applicants must describe the connected services to be provided, conditions to be treated, impact of COVID-19 in the provider’s area, patient population and approximate number of patients that could be treated by connected care services during this pandemic. Providers who plan to use these funds to treat noncoronavirus patients must describe how this would free up resources that would be used to treat COVID-19 patients and/or how it would otherwise respond to the disease by, for example, facilitating social distancing. Applicants must describe the telecommunications services, information services and devices requested, including how the devices are integral to patient care and whether they would be for patient or provider use. Applicants must also include the amount of funding requested and supporting documentation associated with the costs requested.
Relaxed HIPAA Enforcement
During this emergency period, healthcare providers may wish to communicate with patients and provide telehealth services through remote communications. Some of the technologies and the manner in which they are used may not fully comply with the requirements of HIPAA. To encourage healthcare providers to use telehealth services, the OCR will not impose penalties against health care providers for noncompliance with the regulatory requirements under HIPAA in connection with the good faith provision of telehealth during the COVID-19 public health emergency.
Providers may use any nonpublic-facing remote communications product to communicate with patients. Examples include Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, Zoom or Skype. Providers should enable all encryption and privacy modes and should notify patients that there may be privacy risks with using third-party applications. Public facing applications such as Facebook Live, Twitch, TikTok or other similar public-facing video communication applications are not permitted.
This relaxed enforcement applies to all telehealth services including for diagnosis and treatment of health conditions that are unrelated to COVID-19. By way of example, a healthcare provider is permitted to use a patient’s phone or desktop computer in order to asses both COVID-19 symptoms as well as unrelated ailments such as a sprained ankle, dental consultation, psychological evaluation and other conditions.
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Duane Morris has created a COVID-19 Strategy Team to help organizations plan for, respond to and address this fast-moving situation. Contact your Duane Morris attorney for more information. Prior Alerts on the topic are available on the team’s webpage.
For More Information
If you have any questions about this Alert, please contact Richard P. Darke, Nicole Mirjanich, any of the attorneys in our mHealth, Telemedicine and Health Information Technology Group, any member of the COVID-19 Strategy Team or the attorney at the firm with whom you are in regular contact.
Notes
[1] The Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services defines telehealth as the use of electronic information and telecommunication technologies to support and promote long-distance clinical health care, patient and professional health-rated education, public health, and health administration.
[2] One example the CARES Act suggests is remote patient monitoring (i.e., the collection of physiologic data like ECG, blood pressure, or glucose monitoring, digitally stored and transmitted by the patient or caregiver to the home health agency, as defined by 42 C.F.R. §409.46(e)).
[3] The FCC broadly defines “connected care services” as a subset of telehealth that uses internet enabled technologies to deliver services directly to patients at their home. By way of example, these services include remote patient monitoring (e.g., glucometers, pulse oximeters, or other wearable devices to consistently monitor patient vitals), patient health education, store and forward services (e.g., transfer of patient data to physician for interpretation), and video consultations and visits. See the FCC Report and Order.
[4]The program will not fund unconnected devices that patients use at home and share the results with their medical professional remotely. Monitoring devices (e.g., pulse-ox, BP monitoring devices) will only be funded if they are themselves connected. See the FCC Report and Order.
[5] The FCC determines eligibility based on the nonprofit and public health care providers that fall within the categories of health care providers in section 254(h)(7)(B) of the 1996 Act. Interested health care providers that do not already have an eligibility determination can obtain one by filing an FCC Form 460 with the Universal Service Administrative Company (USAC).
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