07.21.2022

Guidance updates for your summer reading list

Summertime and the livin’ is easy  except in the compliance department, where a flurry of recent guidance changes and updates has compliance teams on their toes this summer, trying to keep up.

From new survey guidance for staff vaccinations to new guidance for audio-only telehealth visits, the Centers for Medicare and Medicaid Services (CMS) and the U.S. Department of Health and Human Services (HHS) are providing plenty of memorandums and notices for summer reading.

SimiTree compliance exerts have compiled a list of some of the important changes and clarifications your agency needs to know about.

Emergency Preparedness Testing

When did your agency last activate or reactivate its emergency operating plan for COVID-19, and have you returned to normal operating status? The answer determines whether your agency’s next full-scale community-based exercise or individual, facility-based functional exercise will be required to take place in 2022.

“CMS has issued a memo clarifying the testing exercise requirements to ensure that surveyors, providers and suppliers understand how emergency preparedness testing exemptions work,” said SimiTree Senior Manager Sheila Salisbury-Sizemore. “Some providers will be expected to complete the full-scale exercise in 2022, while others may not need to complete the required testing until 2024.”

Emergency preparedness testing is required under Medicare’s Conditions of Participation (CoPs). When a provider experiences an actual natural or man-made emergency that requires activation of the emergency operating plan, the provider will be exempt from the next required full-scale community-based exercise or individual, facility-based functional exercise. This is true for both inpatient and outpatient providers.

Among clarifications issued by CMS:

  • Testing will be required in 2022 if the provider claimed the full-scale exercise exemption in 2020 based on its activated emergency plan for COVID-19 response and has since resumed normal operating status.
  • Testing will be required in 2024 if the provider claimed the full-scale exercise exemption in 2021 based on its activated emergency plan for COVID-19 response and has since resumed normal operating status.
  • Exceptions may apply if the provider has reactivated its emergency plan for an actual emergency during its 12-month cycle for 2022.

For details, read the full CMS memo here.

HIPAA and Audio-Only Telehealth

Are providers allowed to make use of audio-only telehealth visits with patients?

“The U.S. Department of Health and Human Services has answered that question with a yes, as long as remote communications are conducted in a manner consistent with all Health Insurance Portability and Accountability Act of 1996 (HIPAA) rules for privacy, security and breach notification,” Sizemore said.

HHS issued guidance in June to explain the expectations and requirements associated with audio-only telehealth, she said.

“Guidance addresses how providers will need to address potential risks and vulnerabilities to the confidentiality of health information and offers a reminder to agencies that should identify, assess and address this risk as part of ongoing risk analysis and management processes,” Sizemore said.

Read the full memo here.

New Survey Guidance for Staff Vaccinations

This one is good news, with a slight relaxation of earlier guidance that had agencies highly concerned about the risk of immediate jeopardy citations for failing to meet staff vaccination requirements, Sizemore said.

“The new guidance eliminates some routine assessments for staff vaccination compliance, and also recognizes an agency’s good faith efforts to comply with vaccine requirements for staff,” Sizemore said.

Previously, guidance for federal, state and Accreditation Organization (AO) surveyors called for assessment of compliance with the vaccination requirements any time an agency underwent a complaint survey for any reason, as well as during surveys for initial certification, standard recertification or reaccreditation.

In June, CMS posted a memo containing new instructions for surveyors to assess vaccine requirements during complaint surveys in response to complaints specifically alleging staff vaccination noncompliance, but not routinely during all complaint surveys.

Instructions to assess for vaccination compliance did not change for initial certification, standard recertification or reaccreditation surveys.

The new guidance eases some of the pressure on agencies dealing with mandatory staff vaccinations during the nationwide labor shortage, Sizemore said.

“The memo CMS issued in June also instructs state survey agencies to reach out to CMS before citing vaccine requirements at the immediate jeopardy level, or Condition level,” Sizemore said. CMS wants to ensure that good faith efforts by providers are recognized, and it wants to evaluate harm or potential harm to providers based on the incidence of COVID-19 in the community, she said.

Read the full CMS memo here.

SimiTree can help

If your organization needs help with compliance, the experts at SimiTree provide best-in-the-industry comprehensive compliance and regulatory support.

Our team is made up of clinical experts who are certified in healthcare compliance with extensive experience in government audits and appeals at all levels, including ALJ expert witness. We help providers navigate the audit and appeal process, provide staff training, and implement sustainable plans of correction.

In addition, current, former, and certified surveyors are available to conduct mock surveys and full compliance assessments to fully identify your vulnerabilities.

Use the form below to reach out to us to begin the conversation about shoring up your compliance.

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