CMS Waivers Under COVID-19: An Overview of Compliance Considerations – Part 2

May 6, 2020 Marti Arvin

The Center for Medicare and Medicaid Services (CMS) has issued a number of waivers of certain regulatory obligations for multiple segments of the healthcare industry during the public health emergency (PHE). These waivers modify the compliance obligations in a number of ways. This article will focus on some of the waivers issued for teaching hospitals, teaching physicians, medical residents, and hospitals as part two of a three-part series regarding the waivers for this industry segment.

Waivers for Hospitals

The Emergency Medical Treatment and Labor Act (EMTALA) helps ensure that when a patient presents to an emergency department (ED) their ability to pay will not be a factor in determining if they are provided care. EMTALA requires that a patient receives a medical screening exam (MSE) to determine if an emergency condition exists and that any emergency condition is stabilized before discussing the patient’s ability to pay. Since the PHE was declared CMS has issued waivers permitting hospitals to open temporary expansion sites. Hospitals can provide and get paid for services at these sites even though they are not a hospital department.

Because CMS as allowed for these temporary expansion sites, the sites are considered hospital departments. While a MSE would normally occur in the ED, under the waiver, CMS is allowing the MSE to be done at an offsite location. This gives hospitals the flexibility to separate potential/suspected COVID-19 positive cases from non-COVID-19 related emergencies.

Compliance Considerations for Offsite EMTALA MSEs

However, there are some of the compliance considerations to think about. While the location is waived the organization will still need to ensure all applicable criteria under EMTALA is met such as having the appropriately licensed individual providing the MSE. This may be an area that the compliance professional considers auditing once the PHE is lifted.

Waivers for Certain Paperwork Obligations

There have been waivers issued for certain paperwork obligations hospitals must meet under the Medicare regulations. CMS specifically waived the obligation to provide the medical record within a reasonable timeframe. This likely means the timeframe prescribed by the Health Insurance Portability and Accountability Act (HIPAA) regulations. The obligation to have a written policy and procedure regarding visitation with a patient in isolation or quarantine for COVID-19 has also been waived. The remaining waiver under this caption appears to be expanding when a hospital can seclude a patient. Under the regulations, seclusion may only be used to manage a patient who is engaged in violent or self-destructive behavior.[1]

It is unclear exactly what CMS’s intent is regarding seclusion. However, if seclusion is used for other patients, the hospitals should strive to ensure the other provisions of this regulatory provision are met and documented, such as:

  • There has been a determination that less restrictive means of intervention will be ineffective to protect the patient, staff members, or others from harm.
  • The method of seclusion is the least restrictive to protect the patient, staff members, and others from harm.
  • The seclusion is in a modification of the patient’s care plan and implemented in accordance with an appropriate seclusion technique.
  • The seclusion was ordered by a physician or other licensed practitioner responsible for the care of the patient.
  • The order is reviewed under the appropriate regulatory timetable depending on the age of the patient.[2]

These waivers are only applicable to hospitals that are in an area of widespread confirmed cases. Widespread confirmed cases are defined as states with 51 or more confirmed cases. As of May 7, 2020, that would be all 50 states in the United States. But CMS has indicated they will reassess these waivers as cases decrease.

Compliance Considerations for Waivers for Certain Paperwork Obligations

Organizations should consider educating staff to comply with the regulations if feasible and not use the waiver. The organization will also want to ensure employees are aware of the need to return to the pre-PHE processes once the PHE has been lifted. For most states it is likely the PHE will have expired or lifted before their confirmed cases drop below 51 but the organization may still wish to monitor this if they are in a state with lower volume of confirmed cases.

Waivers Regarding the Hospital’s Physical Environment

CMS also issued a waiver for the conditions of participation (COP) requirement that hospital care be provided in a hospital space. This waiver permits hospitals to use non-hospital buildings and space for patient care. The waiver requires the building or space be approved by the state to ensure the safety and comfort of patients is appropriately addressed.  There is also a waiver that allows hospitals to establish temporary expansion sites for patient care. These sites could be an ambulatory surgery center, a repurposed gymnasium, tents, or other sites. The temporary expansion sites must meet all of the Medicare COP that are in place during the PHE.

Compliance Considerations for Waivers Regarding the Hospital’s Physical Environment

Organizations should have a process in place to ensure the temporary expansion site is in compliance with the applicable Medicare COP. The compliance office may wish to audit the process for documenting, billing, and coding services that were billed during the PHE from these expanded locations.

This is not an all-inclusive list of the compliance considerations for the waivers discussed thus far. These are just some of the things compliance professionals may wish to think about. This is a highly complex time with changes occurring frequently. There are a number of additional waivers that CMS has issued for the healthcare industry. Most of the remaining waivers that have been issued for hospitals and more of the compliance considerations associated with them will be addressed in the next segments of this blog post series.

Additional Resources

[1] 42 C.F.R. § 482.13(1)(ii).

[2] 42 C.F.R. § 482.13(2)-(5) & (8).

 

About the Author

Marti Arvin

Marti Arvin, ExecutiveAdvisor for CynergisTek brings more than three decades of operational and executive leadership experience in the fields of compliance, research and regulatory oversight in academic medical and traditional hospital care settings to her position in CynergisTek. Arvin leads strategic business development around compliance services and utilizes her industry recognized expertise in health research to inform the development of privacy and security services to meet that communities underserved needs. She is a nationally recognized speaker and contributor to the thought leadership around healthcare compliance and research, and contributes to CynergisTek’s industry outreach and educational programs. Arvin has extensive experience in building and managing compliance and research programs. Arvin previously served as the Chief Compliance Officer for Regional Care Hospital Partners and the UCLA Health System and David Geffen School of Medicine. She has a legal background from obtaining her J.D. and holds CHC-F, CCEP-F, CHRC and the CHPC certifications. She is recognized as an expert on compliance and privacy issues from her published articles, lectures and presentations at national conferences. She was a board member to the Health Care Compliance Association between 2008 and 2011 and was on the Compliance Certification Advisory Board for over eight years. She also served on the certification committee for the CHC, CHC-F, CCEP, CCEP-F, CHRC and CHPC.

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