CMS Waivers Under COVID-19: An Overview of Compliance Considerations – Part 4

CMS Waivers Under COVID-19: An Overview of Compliance Considerations - Part 4

May 6, 2020Marti Arvin

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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 podcast series will focus on some of the waivers issued for teaching hospitals, teaching physicians, medical residents, and hospitals as part three of a three-part series regarding the waivers for this industry segment.

Waivers for Verbal Orders

CMS generally frowns upon verbal orders and the regulations indicate they should be used infrequently, particularly for drugs and biologicals.^[1] Verbal orders are expected to be promptly authenticated by the person issuing the order, generally within 48 hours unless state law specifies a short time period. The CMS conditions of participation (COP) require that verbal orders be dated and time. The verbal order may only be taken by someone authorized to do so by the hospital's policy, who is acting within the scope of their licensure. There is also a requirement that the verbal order be read back to the ordering provider.

As part of the PHE, CMS as issues a waiver permitting the use of verbal orders more broadly, including for drugs and biologicals. There is still the obligation to date and sign the verbal order. The read back must also still occur. However, the period to authenticate the order can go beyond 48 hours. The intent of this waiver is to free up provider time for direct patient care.

Compliance Considerations for Waivers Associated with Verbal Orders

Verbal orders have long been a compliance concern, with the failure to timely authenticate being one of the biggest issues. The temptation under the CMS waivers for the PHE might be for staff to become even more lax. The compliance professionals may wish to audit verbal orders taken during the PHE once the PHE is lifted to ensure verbal orders:

• Were always taken by someone authorized to do so
• Were signed and dated
• Were appropriately authenticated even if it was not within 48 hours or the authenticated timeframe followed any applicable state law provisions.

Compliance professionals may also wish to review verbal orders taken after the PHE is lifted to ensure their use returns to infrequent.

Waivers for Reporting ICU Deaths Involving Soft Restraints

Medicare COPS require hospitals to report any intensive care unit (ICU) death where the patient was in soft restraints. The reporting obligation is for instances where the patient died as a result of their disease process and the use of restraints was not a contributing factor as well as instances where the restraints might have been a contributing factor. The death must be reported by the close-of-business on the next business day following the patient's death. CMS has issued a waiver during the PHE lifting the obligation to report any ICU death when the died as a result of their disease process and the soft restraints were not a potential contributing factor. CMS has not clarified the timeframe for reporting these deaths. The requirement to report a death when the restraints might have been a contributing factor remain the same.

Compliance Considerations for Waivers for Regarding Use of Soft Restraints

Organizations should consider evaluating their process for reporting ICU deaths where the patient was in soft restraints. The evaluation should ensure ICU deaths where the restraints might have been a contributing factor are timely reported. The organization should also ensure ICU deaths where the restraints were not a contributing factor are reported at some point. Compliance professionals will also want to ensure the organization returned to regulatory reporting obligations once the PHE is lifted. An audit might also be considered to assess whether the use of soft restraints increased during the PHE.

Waivers Regarding Provider Enrollment

CMS has indicated that it will modify several provider enrollment functions during the PHE. Specifically, CMS will not do fingerprint based criminal background checks or site visits. CMS will also postpone any revalidation actions. Any "clean" application that is submitted to CMS will be approved within seven days. For applications approved in this manner the provider will be granted provisional billing privileges. Once the PHE is lifted, the provider will be asked to submit a complete CMS-855 enrollment form. If the provider does not respond within 30 days, then the temporary billing privileges will be deactivated.

Compliance Considerations for Provider Enrollment Waivers

Compliance professionals should consider tracking any provider entity or individual who as granted temporary billing privileges under the PHE waiver. Once the PHE waiver is lifted, compliance should help ensure the full CMS-855 enrollment for is timely submitted and that no services are billed if full billing privileges have not been granted. This will help avoid claims denials for services provided by a facility or individual whose privileges are deactivated.

Waivers Related to the Discharge Plan Criteria

Hospitals have obligations when discharging a patient to a post-acute care setting such as a skilled nursing facility (SNF), long term care hospital (LTCH), inpatient rehabilitation facility (IRF) or home health agency (HHA). Part of these obligations are to provide the patient or their family with quality and resource use measures. CMS has waived the obligation to provide this information during the PHE. However, hospitals must still ensure that the post-acute care setting is appropriate for the patient's goals and care as well as provide the necessary medical information.

The waiver also sets aside the requirement to provide the patient or their family with a list of SNF, LTCH, IRF or HHAs available to the patient, the requirement to inform the patient they are free to choose any Medicare participating provider, or to identify in the discharge plan any disclosable conflict of interest with any HHA or SNF to which the patient is discharged.

Compliance Consideration for Waivers Related to the Discharge Planning Criteria

Hospitals should have a process to ensure that there is not a conflict of interest with the post-acute care setting to which a patient is discharged. Once the PHE is lifted, the compliance professional should consider reviewing the locations to which patients were discharged for any change in the patterns from the pre-PHE metrics. If such a change exists, the organization should consider auditing the discharge process to help ensure there are not compliance concerns surrounding the change in metrics. Compliance should also be prepared to audit the discharge planning process once the PHE has been lifted to ensure the process meets all re-imposed regulatory obligations.

Waivers for Hospitals in Other Obligations

CMS also waived a variety of other obligations for hospitals. Under the CMS regulations, hospitals are must ensure the medical record is completed within 30 days of discharge. CMS has waived this obligation. CMS also waived the obligation to provide patients with Advanced Directive information. Hospitals will be given an extension of time to report the Inpatient Prospective Payment Wage Index Occupational Survey mix until August 3, 2020. CMS may consider further extensions for facilities having difficulty meeting the new deadline.

Hospitals are also being granted a waiver for certain utilization review (UR) obligations. The entire Medicare utilization review plan process that requires a UR plan, a UR committee, and a review of all Medicare and Medicaid admissions for medical necessity of the admission, duration of the stay, and services provided.^[2]

CMS has also waived the obligation to have a written policy and procedure for the process to evaluate an emergency in an off-campus location and for emergency preparedness. There is also a waiver of the obligation to have a current therapeutic diet manual approved by a dietician and medical staff available to all medical, nursing, and food services personnel. These three waivers are only applicable to the surge facilities/locations that might have been opened during the PHE.

CMS has also extended the time for facilities that had costs reports due in March, April, and May. The cost reports due for entities with a fiscal year end (FYE) of October 31 and November 30, 2019, will be due June 30, 2020. For organizations with FYE of December 31, 2019, the cost report will be due July 31, 2020.

Compliance Consideration for Other CMS Waivers

As discussed throughout this blog series, compliance professionals should have a process in place to ensure the organization returned to the pre-PHE regulatory obligations once the PHE has been lifted. Completion of medical records has long been an issue for hospitals. Compliance professionals may consider recommending that the organization define a time length that, while beyond the pre-PHE 30-day deadline still sets a time for complete of medical records during the PHE. Compliance professionals should also ensure that, if applicable the organization meets its reviewed cost report filing deadline.

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 waivers that have been issued for hospitals and the some of the associated compliance considerations have been addressed in the other segments of this blog post series.

Additional Resources

• Listen to my podcast on the topic, CMS Waivers For Hospitals Under COVID-19: An overview of Compliance Considerations - Part III
• Download our 30/60/90 day checklist, "Planning for Incident Response During the COVID-19 Crisis: Tales on Tackling the Security Debit."
• For a full repository of COVID-19 crisis resources, visit our CTEK COVID-19 Communications page for news, articles, podcasts, and more.
• Contact us with any questions regarding the regulatory changes during the COVID-19 crisis.

[1] 42 C.F.R. § 482.13(1)(ii).

[2] 42 C.F.R. § 482.13(2)-(5) & (8).

About the Author

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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