On December 29, 2022, President Biden signed into law H.R. 2716, the Consolidated Appropriations Act (CAA) for Fiscal Year 2023. This legislation included an extension of the major telehealth waivers that were initiated during the federal COVID-19 Public Health Emergency (PHE). On January 30, 2023, the Biden Administration announced its intent to end the COVID-19 national emergency and PHE declarations on May 11, 2023.

At the beginning of the COVID-19 PHE, the Centers for Medicare & Medicaid Services (CMS) used emergency waiver authorities and various regulatory authorities to enable flexibilities so providers could rapidly respond to people impacted by COVID-19. With the announced ending of the PHE, CMS is ending many of these waivers and flexibilities and providing information on re-establishing certain health and safety standards, along with other financial and program requirements.

This table summarizes the known end dates of some major flexibilities and waivers of interest to oncologists. This table is followed by more detail on these provisions and a list of resources for additional information.

Telehealth

The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) on May 9, 2023, filed a temporary rule extending PHE waivers for telemedicine prescribing of controlled substances through November 11, 2023. The rule also provides a grace period through November 11, 2024, for prescribing of controlled substances in the context of telemedicine relationships established on or before November 11, 2023. More information is available on ASCO in Action.

During the PHE, for services requiring direct supervision, physician supervision can be provided virtually using real-time audio/video technology. This “virtual direct supervision” ends December 31, 2023.

Reimbursement of Medicare telehealth services that are not included in Categories 1, 2 or 3 of the telehealth reimbursement list will only be allowed for the 151-day period after the PHE ends. Codes in Category 3 will remain reimbursable through the end of 2023.

During the PHE, providers received physician fee schedule payment as if services had been provided in person, at the non-facility-based payment rate in offices. Beginning in 2024, practitioner services will be paid at the facility rates for telehealth office-based services.

COVID-19 Diagnostics and Treatment

CMS will continue to pay approximately $40 per dose for administering COVID-19 vaccines in outpatient settings for Medicare beneficiaries through 2023. Effective January 1, 2024, CMS will set the payment rate for administering COVID-19 vaccines to align with the payment rate for administering other Part B preventive vaccines.

Effective January 1, 2024, CMS will pay for monoclonal antibodies as the agency pays for biological products under Section 1847A of the Social Security Act and through the applicable payment system, using the appropriate coding and payment rates, similar to the way it pays for administering other complex biological products.

After the end of the PHE, oral antivirals for COVID-19 that otherwise meet the statutory requirements for Part D coverage at section 1860D-2(e) of the Social Security Act must be covered by Part D plans, as a formulary product or through the formulary exception process, immediately upon FDA approval.

Medicare Part B provides payment for remdesivir and its administration under the applicable Medicare Part B payment policy when a facility or practitioner provides it in the outpatient setting, according to the FDA approval and authorization. In most cases, the Medicare patient’s yearly Part B deductible and 20% co-insurance apply.

Workforce

To the extent that National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) require a specific practitioner type or physician specialty to furnish or supervise a service, during the PHE, the Chief Medical Officer or equivalent of a hospital or facility has had the authority to make those staffing decisions. The waiver of this NCD and LCD requirement ends upon the conclusion of the PHE.

During the PHE, CMS expedited any pending or new applications from providers and suppliers, including physicians and non-physician practitioners received on or after March 1, 2020. When the PHE ends, CMS will resume normal application processing times.

During the PHE, CMS allowed practitioners to provide telehealth services from their home without reporting their home address on their Medicare enrollment while continuing to bill from their currently enrolled location. After December 31, 2023, practitioners will be required to resume reporting their home address on the Medicare enrollment. CMS has heard from stakeholders that this provision is causing privacy concerns for providers, and the agency may issue additional guidance prior to December 2023.

During the PHE, CMS allowed licensed physicians and other practitioners to bill Medicare for services provided outside of their state of enrollment. CMS has determined that, when the PHE ends, CMS regulations will continue to allow for a total deferral to state law. Thus, there is no CMS-based requirement that a provider must be licensed in his or her state of enrollment.

Other

The physician self-referral law (“Stark Law”) prohibits a physician from making referrals for certain designated health services payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship, unless the requirements of an applicable exception are satisfied; and prohibits the entity from filing claims with Medicare (or billing another individual, entity, or third party payer) for any improperly referred designated health services. On March 30, 2020, CMS issued blanket waivers of certain provisions of the Stark Law. When the PHE ends, the waivers will terminate, and physicians and entities must immediately comply with all provisions of the Stark Law.

A CMS FAQ on the physician self-referral law indicates that for practices with in-office pharmacies, after the PHE waivers expire, patient surrogates will no longer be able to receive a patient’s drugs in the office, nor will the practice be able to mail drugs to the patient. Stakeholders have requested clarification from CMS on this FAQ and have asked CMS to rescind this policy.

CMS has been waiving signature and proof of delivery requirements for Part B drugs and Durable Medical Equipment (DME) when a signature cannot be obtained because of the inability to collect signatures. After the PHE, signature and proof of delivery requirements will be reinstated for Part B drugs and DME.

Additional Resources

CMS Frequently Asked Questions: CMS Waivers, Flexibilities, and the End of the COVID-19 Public Health Emergency (last updated May 5, 2023)

CMS Website: Coronavirus Waivers and Flexibilities

CMS Provider-specific Fact Sheet: Physicians and Other Clinicians

CMS Provider-specific Fact Sheet: Medicare Shared Savings Program

For Patients

Preparing for the End of the U.S. Public Health Emergency (PHE): What People With Cancer Should Know | Cancer.Net