Background
On March 6, 2020, the “Coronavirus Preparedness and Response Supplemental Appropriations Act” became law. In addition to providing healthcare agencies with more money to address the COVID-19 outbreak, it also loosens existing telehealth restrictions in order to enhance patient access to care services. On March 17, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that they have expanded the waiver for telehealth in several areas, including the care of new patients for the diagnosis and treatment of COVID-19 as well as other conditions unrelated to the public health emergency. However, it does not open up telehealth billing to new practitioners. On March 27, 2020, the "Coronavirus Aid, Relief, and Economic Security Act” (CARES Act) was passed. Along with provisions centered on shoring up the economy and providing additional support for medical response, CARES includes additional funding and flexibility for telehealth provision.
Telehealth Regulations Waiver
The new laws give the Health & Human Services (HHS) Secretary the authority to waive certain restrictions on telehealth during a declared public health emergency. As of March 30, 2020, the Secretary has waived requirements in several different areas:
- Originating site: The Secretary has waived the “originating site” requirement for identified geographic areas designated an “emergency area.” Under normal conditions, a beneficiary must travel to an actual site of care – the originating site -- to receive telehealth services, but the waiver authority allows beneficiaries to receive services wherever they are. Because of the COVID-19 public health emergency, the Secretary has also waived the geographical site restrictions on Medicare telehealth services to allow all areas and locations within the country delivery of these services, including patients’ homes.
- Device Type: The Secretary has loosened restrictions on the types of devices that can be used for telehealth services so that personal phones and tablets may be utilized, provided that the beneficiary has both audio and visual feeds to the clinician. Practitioners are able to use everyday communication technologies such as FaceTime or Skype during the COVID-19 public health emergency without breaking HIPAA rules.
- Patient and Service Eligibility: Both new and existing patients may now access telehealth for a wide range of services. Previously, telehealth was available for a fairly limited range of services and required that the provider or another practitioner within the provider’s practice had provided telehealth services to the patient within the past three years. Now, new patients can receive telehealth services. Although the telehealth expansion still requires informed consent and beneficiary initiation of the encounter, the changes significantly increase the number of patients who can take advantage of telehealth services.
All other telehealth regulations, including the list of “qualified providers” remain in effect. Thus, ASHP’s understanding is that pharmacists can provide telehealth services incident to a Medicare-eligible provider, but cannot directly bill Medicare for these services (more information is provided in the billing and supervision section below).
New Funding and Other Changes
The CARES Act further enhances flexibility for COVID-19 response. CARES expands the waiver authority of the HHS Secretary beyond what was initially allowed by the national emergency declarations, empowering him to waive any Social Security Act provision that impedes patient care delivered via telehealth during the public health emergency. The law also removes access barriers for individuals with high-deductible health plans, who previously could not access telehealth services until their deductible was satisfied without risking their eligibility for Health Savings Accounts. Further, CARES extends telehealth coverage to Rural Health Centers (RHCs) and Federally Qualified Health Centers (FQHCs) (to be implemented by CMS) and removes periodic in-person requirements for home dialysis and hospice services during the COVID-19 public health emergency. Finally, CARES invests in expanding the telehealth infrastructure nationally by authorizing $29 million per year for the next four years for the telehealth network and telehealth resource center grant programs.
Telehealth Billing and Supervision
On March 30, CMS announced a number of new regulatory flexibilities for providers and services. CMS’s fact sheet on physicians and other providers provides important clarifications around billing and coding of telehealth and phone-based services. Based on the new information, it appears CMS is willing to be relatively flexible with billing for telehealth during the national emergency period. The fact sheet makes it clear that pharmacists can provide incident-to services via telehealth. CMS considers pharmacists “auxiliary staff” and notes in the following:
"Medicare Physician Supervision and Auxiliary Personnel: The physician can enter into a contractual arrangement that meets the definition of auxiliary personnel at 42 CFR 410.26, including with staff of another provider/supplier type, such as a home health agency (defined under @ 1861(o) of the Act) or a qualified home infusion therapy supplier (defined under @ 1861(iii)(3) (D)), or entities that furnish ambulance services, that can provide the staff and technology necessary to provide care that would ordinarily be provided incident to a physicians' service (including services that are allowed to be performed via telehealth). In such instances, the provider/supplier would seek payment for any services provided by auxiliary personnel from the billing practitioner and would not submit claims to Medicare for such services."
While ASHP has advocated for all telehealth services to be provided under general supervision (i.e., the supervising clinician does not have to be in the same office suite while services are provided), CMS is still requiring “direct supervision.” However, per the CMS fact sheet, “direct supervision” can now be provided remotely as well:
"Medicare Physician Supervision requirements: For services requiring direct supervision by the physician or other practitioner, that physician supervision can be provided virtually using real-time audio/video technology."
This should remove the need for pharmacists to be physically present in the same office as supervising physicians.
Practical Implications and Next Steps
It is important to note that any state restriction on telehealth services, such as scope-of-practice or licensure requirements, remains in effect. Thus, restrictive state laws could impede the federal telehealth expansion. To facilitate unimpeded patient access, ASHP has recommended that states/state boards of pharmacy remove any regulatory barriers to telehealth provision. ASHP anticipates an ongoing dialogue with CMS as the COVID-19 response continues. If you have any questions regarding provision of telehealth, or if you have communications from your Medicare Administrative Contractor or CMS regarding telehealth that you are willing to share with ASHP to inform our conversations with the agency, please send them to Jillanne Schulte Wall at jschulte@ashp.org The Rubik's Cube seems to be an impossible puzzle but it's easy to solve it using algorithms.