On April 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued new regulatory waivers and rule changes aimed at expanding access to care and allaying regulatory burdens on healthcare providers during the COVID-19 pandemic. Many of these initiatives take the form of a blanket waiver that entered effect immediately and will apply for the duration of the COVID-19 Public Health Emergency declared by Department of Health and Services (HHS) Secretary Alex M. Azar II on January 31. These latest actions build on temporary regulatory waivers and rule changes for the emergency that CMS announced on March 30 and April 10.

CMS announced the following aims for the April 30th initiatives, among others:
1) easing rules that potentially constrain ready deployment of healthcare practitioners;
2) increasing access to telehealth and homebased care for Medicare patients; and
3) issuing new rules that broaden COVID-19 testing opportunities for Medicare and Medicaid beneficiaries. Below, we review some of CMS's recent activities pertaining to each.

1) Eased rules for practitioner deployment

• CMS is waiving a requirement for ambulatory surgery centers to periodically reappraise medical staff privileges during the COVID-19 emergency. Consistent with a change made for hospitals, this will allow physicians and other practitioners whose privileges are expiring to continue taking care of patients.¹
• CMS will not reduce Medicare payments for teaching hospitals that shift their residents to other hospitals to meet COVID-related needs, or penalize hospitals without teaching programs that accept these residents. This change removes barriers so teaching hospitals can lend available medical staff support to other hospitals.
• CMS is allowing physical and occupational therapists to delegate maintenance therapy services to physical and occupational therapy assistants in outpatient settings. This frees up physical and occupational therapists to perform other important services and improve beneficiary access.

2) Increased access to telehealth and homebased care

• For the duration of the COVID-19 emergency, CMS is waiving limitations on the types of clinical practitioners that can furnish Medicare telehealth services. Prior to this change, only doctors, nurse practitioners, physician assistants, and certain others could deliver telehealth services. Now, other practitioners are able to provide telehealth services, including physical therapists, occupational therapists, and speech language pathologists.
• Hospitals may bill for services furnished remotely by hospital-based practitioners to Medicare patients registered as hospital outpatients, including when the patient is at home when the home is serving as a temporary provider-based department of the hospital. Examples of such services include counseling and educational service as well as therapy services. This change expands the types of practitioners that can provide telehealth.
• Hospitals may bill as the originating site for telehealth services furnished by hospital-based practitioners to Medicare patients registered as hospital outpatients, including when the patient is located at home.
• CMS previously announced that Medicare would pay for certain services conducted by audio-only telephone between beneficiaries and their doctors and other clinicians. Now, CMS is broadening that list to include many behavioral health and patient education services. CMS is also increasing payments for these telephone visits to match payments for similar office and outpatient visits, retroactive to March 1.
• Until now, CMS only added new services to the list of Medicare services that may be furnished via telehealth using its rulemaking process. CMS is changing its process during the emergency, and will add new telehealth services more quickly, on a sub-regulatory basis. CMS announced that it is considering requests by practitioners now learning to use telehealth as broadly as possible.
• As mandated by the CARES Act, CMS is paying for Medicare telehealth services provided by rural health clinics and federally qualified health clinics. Previously, these clinics could not be paid to provide telehealth expertise as "distant sites." Now, Medicare beneficiaries located in rural and other medically underserved areas will have more options to access care from their home without having to travel.
• Since some Medicare beneficiaries don't have access to interactive audio-video technology that is required for Medicare telehealth services, or choose not to use it even if offered by their practitioner, CMS is waiving the video requirement for certain telephone evaluation and management services, and adding them to the list of Medicare telehealth services. As a result, Medicare beneficiaries will be able to use an audio-only telephone to get these services.
• Nurse practitioners, clinical nurse specialists, and physician assistants can now provide home health services, as mandated by the CARES Act. These practitioners can now 1) order home health services; 2) establish and periodically review a plan of care for home health patients; and 3) certify and re-certify that the patient is eligible for home health services. Previously, Medicare and Medicaid home health beneficiaries could only receive home health services with the certification of a physician. These changes are effective for both Medicare and Medicaid.

3) New rules that support and expand COVID-19 testing

• Medicare will no longer require an order from a beneficiary's treating practitioner for coverage of COVID-19 tests and certain laboratory tests required as part of a COVID-19 diagnosis. During the COVID-19 emergency, such tests may be covered when ordered by any practitioner so authorized under state law. Also, Medicare will no longer require for coverage the practitioner's written order for a COVID-19 test.
• CMS now permits practitioners to bill Medicare for services where they collaborate with pharmacists to provide COVID-19 assessment and specimen collection services. Pharmacists also can perform certain COVID-19 tests if enrolled in Medicare as a laboratory, in accordance with the pharmacist's scope of practice and state law. With these changes, beneficiaries can get tested at "parking lot" test sites operated by pharmacies and other entities consistent with state requirements. CMS states that such point-of-care sites will afford means for expanding COVID-19 testing capacity.
• CMS will pay hospitals and practitioners to assess beneficiaries and collect laboratory samples for COVID-19 testing, and make separate payment when that is the only service the patient receives. This builds on previous action to pay laboratories for technicians to collect samples for COVID-19 testing from homebound beneficiaries and those in certain non-hospital settings, and encourages broader testing by hospitals and physician practices.
• Medicare and Medicaid are covering certain serology (antibody) tests, which may aid in determining whether a person may have developed an immune response and may not be at immediate risk for COVID-19 reinfection. Medicare and Medicaid will cover laboratory processing of certain FDA-authorized tests that beneficiaries self-collect at home.
• CMS is allowing payment for certain partial hospitalization services—that is, individual psychotherapy, patient education, and group psychotherapy—that are delivered in temporary expansion locations, including patients' homes.
• CMS will not enforce certain clinical criteria in local coverage determinations that limit access to therapeutic continuous glucose monitors for beneficiaries with diabetes. As a result, clinicians will have greater flexibility to allow more of their diabetic patients to monitor their glucose and adjust insulin doses at home.

CMS's new interim final rule with instructions for filing public comments can be found online at https://www.cms.gov/files/document/covid-medicare-and-medicaid-ifc2.pdf.

[1] CMS and most state governments published requirements and/or recommendations for limiting non-essential elective surgery and medical procedures for adults during the COVID-19 emergency. CMS has further urged ambulatory surgery centers to consider helping address the needs in COVID-19 surge areas, by furnishing inpatient services under arrangement for a hospital, or becoming provider-based to a hospital, or choosing to enroll as a hospital themselves.