May 2023, Legal Intelligencer article by Lamb McErlane Health Law attorneys Vasilios J. (Bill) Kalogredis and Artyom (Art) Sharbatyan.

In a positive development in the long-time battle against COVID-19, the Department of Health and Human Services (HHS) declared that the federal Public Health Emergency (PHE) for COVID-19 was to expire on May 11, 2023. The decision was based on current trends and the belief that now was the time to transition away from this emergency phase.

During the PHE, emergency declarations, legislative actions by Congress, and regulatory changes across government, including by the Centers for Medicare & Medicaid Services (CMS), enabled healthcare providers to adapt and optimize the delivery and access to care. Many of these alterations will remain permanent or extended through Congressional action, but some waivers and flexibilities have expired as they were intended to address the immediate needs of the pandemic rather than permanently replace existing rules and regulations.

To provide clarity regarding the post-PHE landscape, on February 27, 2023 CMS released a fact sheet detailing some key aspects that covered guidelines on continued access to COVID-19 vaccination, testing, and treatment options, the status of remote (such as telehealth) healthcare services and their availability beyond the emergency phase, information on the ongoing flexibility provided to healthcare professionals, as well as the expanded hospital capacity for inpatient care within a patient’s home.

The HHS, along with States and private insurance plans, will continue to provide guidance in the months ahead. It is important to note that the administration’s response to the pandemic will not be solely dependent on the PHE status, as there are numerous measures and flexibilities that will remain unaffected during the transition. So, this is not done. It is a moving target, and one must constantly read the latest from the government to make decisions with the latest guidance.

The termination of the PHE marks a significant step forward, emphasizing the strides made in curbing the virus’s impact and providing a sense of confidence in healthcare delivery moving forward. For more information please see the transition roadmap that can be found at www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19.

COVID-19 vaccines, testing, and treatments

Medicare

• Vaccines: Medicare beneficiaries will continue to have access to COVID-19 vaccinations without cost-sharing after the PHE ends.
• Testing: Traditional Medicare recipients can still receive COVID-19 PCR and antigen tests at no cost when ordered by a physician or certain other midlevel healthcare providers and performed by a laboratory. Medicare Advantage (MA) plan holders may experience changes in cost-sharing for tests.
• Treatments: Medicare coverage for treatments for people exposed to COVID-19 remains unchanged after the PHE end. Cost-sharing and deductibles will continue to apply for treatments, including oral antivirals.

Medicaid and CHIP

Vaccines, Testing, and Treatment: Under the American Rescue Plan Act, Medicaid and Children’s Health Insurance Program (CHIP) must cover COVID-19 vaccinations, testing, and treatments without cost-sharing until the end of the first calendar quarter starting one year after the PHE. After that, coverage may vary by state. Eighteen states and U.S. territories offered Medicaid coverage for uninsured individuals, which is planned to cease upon PHE end.

Private Health Insurance

Vaccines: Most private health insurance plans must cover COVID-19 vaccines administered by in-network providers without cost-sharing. Vaccination from an out-of-network provider, may cause additional responsibility for a portion of the cost.

Testing: Mandatory coverage for over-the-counter and laboratory-based COVID-19 tests will end after the PHE, although coverage may differ across health plans.

Treatments: Coverage for treatments remains the same, with cost-sharing and deductibles continuing to apply.

It is important to check with your specific insurance provider for detailed information on coverage post-PHE. While some changes will occur, access to vaccines, testing, and treatments will remain available. The end of the emergency phase is a sign of progress in combating the virus, but continued vigilance and adherence to health guidelines are still necessary to ensure public safety and health.

Access to Telehealth Services

The COVID-19 pandemic has increased the use of telehealth services. In response to the pandemic, the Secretary of HHS issued waivers to Medicare rules that allowed individuals to receive telehealth services in their homes without location limitations. Telehealth services were provided through telecommunications systems, such as computers and phones, and allowed healthcare providers to give care to patients remotely in place of in-person office visits.

The Consolidated Appropriations Act, 2023, has extended many telehealth flexibilities until December 31, 2024. This extension allows people with Medicare to access telehealth services in any geographic area in the United States, stay in their homes for telehealth visits that Medicare pays for, and receive certain telehealth visits audio-only. Medicare Advantage plans may offer additional telehealth benefits, and individuals in these plans should check with their plan about coverage for telehealth services.

For Medicaid and CHIP, telehealth flexibilities have been offered by many state Medicaid programs long before the pandemic.  Coverage will vary by state, but CMS encourages states to continue to cover Medicaid and CHIP services when delivered via telehealth.  For more information on this, visit www.medicaid.gov/medicaid/benefits/downloads/medicaid-chip-telehealth-toolkit-supplement1.pdf.

Now that PHE is over, coverage for telehealth services by private insurance plans will vary. Private insurance may impose cost-sharing, prior authorization, or other forms of medical management on telehealth and other remote care services.

After December 31, 2024, when Medicare telehealth flexibilities are scheduled to expire, some Accountable Care Organizations (ACOs) may offer telehealth services that allow primary care doctors to care for patients without an in-person visit, regardless of where they live. Patients are encouraged to check with their ACO participating health care provider to see what telehealth services are available.

COVID-19 Waivers and Administrative Flexibilities: How Health Care Providers and Suppliers are Affected

In times of emergencies or natural disasters, CMS often issues standard group waivers, known as blanket waivers, to provide flexibility in healthcare delivery. These waivers, which have been particularly relevant during the COVID-19 pandemic, are typically applicable to entire provider categories and serve to expand healthcare capacity and address critical challenges. However, it’s important to note that these waivers are temporary and require legislative changes to become permanent.

One example of a blanket waiver is the requirement for a three-day prior inpatient hospitalization for Medicare coverage of a skilled nursing facility stay. During emergencies, this requirement is waived to ensure that patients can access necessary care without delays. Similarly, Critical Access Hospitals (CAHs) are typically limited to 25 inpatient beds, but waivers allow them to expand their capacity as needed. Additional waivers permit the use of alternative facilities, such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories, to accommodate acute care patients. More information can be found at www.cms.gov/coronavirus-waivers.

Hospital at Home

CMS took steps to address specific challenges faced by healthcare providers during the pandemic, resulting in the implementation of various initiatives.

One such initiative is the Acute Hospital Care at Home program, which allows hospitals to provide inpatient care in patients’ homes. This flexibility helps hospitals expand their capacity and meet the increasing demand for care. The program, implemented in response to the strain on hospitals caused by COVID-19, has been extended through December 31, 2024, under the Consolidated Appropriations Act, 2023. Hospitals across different settings and sizes, ranging from small rural facilities to large academic institutions, have participated in this program.

Nurse Aide Training for Nursing Homes

Another area where flexibility was necessary during the pandemic was in nurse aide training for nursing homes. To address staffing shortages, CMS provided a blanket waiver for nurse aide training and certification requirements. This waiver allowed nurse aides to work beyond the usual four-month limit without completing their training. However, CMS ended this waiver in 2022 and emphasized the importance of training and certification to ensure quality care for nursing home residents. While individual, time-limited waivers were granted to address certification barriers caused by workforce shortages, all nursing aide training emergency waivers for states and facilities are planned to end at the conclusion of the PHE.

Virtual Supervision

 To enable more people to receive care, CMS also temporarily changed the definition of “direct supervision,” allowing healthcare professionals to provide virtual supervision through real-time audio/video technology. This change facilitated the provision of telehealth services, allowing healthcare providers to be immediately available without physical presence. However, this temporary exception to direct supervision will expire on December 31, 2023.

Scope of Practice

 Scope of practice was also addressed during the pandemic. For example, CMS waived the requirement for certified registered nurse anesthetists (CRNAs) to be supervised by a physician, allowing hospitals, Critical Access Hospitals (CAHs), and Ambulatory Surgical Centers (ASCs) to determine CRNA supervision based on state law and hospital discretion. This waiver, which allowed CRNAs to practice to the fullest extent of their licensure, will end at the conclusion of the PHE, with states having the option to apply for exemptions if they meet certain criteria.

Health and Safety Requirements

Many emergency waivers related to health and safety requirements expired on May 11, 2023. For example, during the PHE, the time frame to complete a medical record at discharge was extended. Typically, a patient’s medical records are required to be completed at discharge to ensure there are no gaps in patients’ continuity of care. This means each provider should have the most up-to-date understanding of their patients’ medical records.

Medicaid Continuous Enrollment Condition

The continuous enrollment condition for Medicaid recipients is no longer tied to the PHE. Under the Families First Coronavirus Response Act, states that received a temporary increase in the Federal Medical Assistance Percentage (FMAP) were unable to terminate Medicaid enrollment for most individuals since beginning of the pandemic. However, as part of the Consolidated Appropriations Act, 2023, the continuous enrollment condition ended on March 31, 2023, and the temporary FMAP increase is being gradually reduced and phased down starting from April 1, 2023, until it ends on December 31, 2023. For more information, visit www.meedicaid.gov/unwinding.

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Vasilios J. (Bill) Kalogredis, Esq. has been exclusively advising physicians, dentists, and other health care professionals and their businesses as to contractual, regulatory and transactional matters for over 45 years. He is Chairman of Lamb McErlane PC’s Health Law Department. bkalogredis@lambmcerlane.com. 610-701-4402.

*Artyom (Art) Sharbatyan contributed to this article. Art has extensive real life practical experience in the healthcare field with particular concentration in dental practice groups. He represents healthcare providers in their business and legal needs at Lamb McErlane, PC’s Health Law Department. asharbatyan@lambmcerlane.com; 610-701-4416.

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