Category Archives: COVID-19

March 20, 2023

Public Health Emergency Ends May 11, 2023: Check Your Readiness

By Kim Stanger

After three years, the federal public health emergency (PHE) will expire May 11, 2023.1 Most of the relaxed regulatory and payor standards will end on or within a few months after the deadline, including many relating to:

  • Federal subsidies for PHE-related services.
  • Medicare coverage and/or the amount of reimbursement for certain services, especially COVID-related care and telehealth services.
  • Medicaid coverage for COVID-related services.
  • Flexibility on standards relating to patient stays (e.g., use of skilled nursing facility (SNF) beds for patients who do not meet SNF criteria; critical access hospital (CAH) 25-bed and/or 96-hour length of stay requirements; etc.).
  • Facility safety, staffing, and operational standards.
  • Use of alternative or expansion sites to provide care (e.g., Hospitals Without Walls Programs; use of other sites to render hospital services; etc.).
  • Practitioner supervision requirements.
  • Charges and cost-sharing amounts for certain services, including COVID testing.
  • Prescribing controlled substances through telehealth services as otherwise governed by the Ryan Haight Act.
  • Use of non-HIPAA compliant modalities to conduct telehealth visits.
  • Stark, Anti-Kickback Statute, and Civil Monetary Penalties waivers concerning arrangements with physicians, patients, and other referral sources.
  • EMTALA guidelines concerning directing patients to other locations.
  • PREP Act liability protections.2

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November 29, 2022

Prepare for the End of the Public Health Emergency: Compliance Concerns

By Kim Stanger

For nearly three years, federal and state agencies have waived or relaxed regulatory requirements and expanded reimbursement for services due to the COVID-19 public health emergency (PHE), but the signs indicate that the party is nearly over. Many states have already ended their emergency exceptions, and the federal PHE appears to be coming to an end. The current 90-day PHE extension issued by the Health and Human Services (HHS) will expire January 11, 2023. (See here.) The Biden Administration has informally promised that it would notify stakeholders at least 60 days in advance of ending the PHE; consequently, there is a good chance that the PHE will be extended an additional 90 days into April 2023, but no formal announcement has issued yet. In the meantime, HHS has warned providers that most of the PHE waivers will end upon termination of the PHE and that providers should prepare now for a return to normal standards. (See CMS, “Creating a Roadmap for the End of the COVID-19 Public Health Emergency” (8/18/22), available here.) Continue reading

January 18, 2022

CMS Vaccine Mandate: New Deadlines

By Kim Stanger

On January 13, 2022, a divided Supreme Court vacated the injunctions that applied to CMS’s vaccine mandate in 24 states, thereby allowing CMS to enforce its mandates in all states except Texas.1 (https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf). Here are key points for providers seeking to comply with the mandate.

Deadlines for Compliance. The effective deadlines for compliance run from the date CMS issued its relevant compliance guidance to survey agencies. For facilities in states that were not subject to an injunction, CMS issued its guidance on December 28, 2021. (QSO-22-07-ALL, available at https://www.cms.gov/files/document/qso-22-07-all.pdf). For facilities in states that were subject to an injunction (i.e., Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Utah, West Virginia, and Wyoming), CMS issued its updated guidance on January 14, 2022. (QSO-22-09-ALL, available at https://www.cms.gov/files/document/qso-22-09-all-injunction-lifted.pdf). As set forth in the guidance, the deadlines are as follows: Continue reading

November 5, 2021

CMS Vaccine Mandate for Healthcare Workers: Resources for Preparing Your Policies

By Kim Stanger

Under the Centers for Medicare & Medicaid Services (CMS)’s new vaccine mandate for healthcare workers, facilities must draft and implement policies and procedures by December 6, 2021 to ensure covered personnel are fully vaccinated or exempted by January 4, 2022. (86 FR 61573). That does not give facilities much time, but here are some resources that may help with compliance. (This alert supplements our summary of the CMS and OSHA mandates.) Continue reading

October 27, 2021

EEOC Issues Expanded Guidance on Religious Objections to COVID-19 Vaccine Mandates

By Curtis Greenwood and Mark Wiletsky

On October 25, 2021, the US Equal Employment Opportunity Commission (EEOC) updated and expanded its technical assistance related to the COVID-19 pandemic by addressing questions regarding vaccine mandates and religious accommodations at a time when COVID-19 vaccination mandates are becoming more widespread. This expanded technical assistance provides important information for employers, employees, and applicants when navigating vaccine-related religious accommodation requests.

The EEOC enforces Title VII of the Civil Rights Act of 1964 (“Title VII”), which prohibits employment discrimination based on religion. Title VII provides a right for applicants and employees to request religious accommodation from employer requirements that conflict with their sincerely held religious beliefs, practices, or observances. If an employer can show that a religious accommodation would cause an undue hardship on its operations, the employer is not required to grant the accommodation. Continue reading

September 23, 2021

Employee Vaccine Information: Privacy Concerns

By Kim Stanger

Given the COVID-19 vaccine mandates, employers—including healthcare entities—will need to confirm their employees’ vaccination status. Employers and healthcare providers must ensure they comply with privacy rules relating to employee vaccination information, including those imposed by the Health Insurance Portability and Accountability Act (HIPAA) and Americans with Disabilities Act (ADA). Continue reading

September 15, 2021

Vaccine Mandate for Healthcare Providers

By Kim Stanger

On September 9, 2021, President Biden announced that the federal vaccine mandate for nursing facilities will be extended to most other healthcare workers. Unfortunately, the announcement raised more questions than it answered. Here is what we do and do not know so far; we may have to wait for the October regulations to learn the specifics. This article supplements our September 10 client alert “Vaccine Mandates Q&A” and focuses on the mandate applicable to healthcare workers. Continue reading

August 24, 2021

FDA Fully Approves Pfizer-BioNTech COVID-19 Vaccine: Implications for Employers

Yesterday, the U.S. Food and Drug Administration (FDA) granted “full approval” to the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age and older. In other words, the Pfizer-BioNTech vaccine (which will now be marketed as “Comirnaty”) has received the top level of clearance a medical drug can possibly obtain from the U.S. government. Many employers and healthcare providers are now wondering how this latest news affects them, particularly with regards to vaccination mandates. Continue reading

December 4, 2020

HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth

On December 3, the U.S. Department of Health and Human Services (HHS) issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19. The Holland & Hart Healthcare Group shares this important update from HHS for your information:

Read the HHS Update

We will continue to monitor this news and will provide more in-depth insights on the impacts of this amendment.

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