Disclaimer: This information is NOT a comprehensive summary of all relevant legislative and regulatory action taken in response to the COVID-19 pandemic that may impact healthcare providers. Instead, it is intended only to illustrate the changing scope of compliance officers’ roles in protecting their organizations in these unprecedented times.
There is no doubt that COVID-19 has created previously unimagined changes to the landscape of healthcare as we know it. In the not-so-distant past, providers historically focused on aligning healthcare services and compliance program objectives with federal, state, and local rules and regulations—a complex goal that may have taken months or years of planning and oversight to achieve. Seemingly overnight, the pandemic has thrust us into a “Wild West” environment of waivers issuing regulatory flexibilities and promises of no sanctions, but also pledging payment for genuine efforts to deliver quality care in combating COVID-19.
So, where do we go from here? Crises have a way of bringing to the forefront issues that were previously overlooked, ignored, or placed on the back burner. How do we take this experience and use the lessons learned to develop new and better practices in this changed environment and beyond? Our new challenge is to use deliberate steps and phases to build a bridge from the pandemic of today to a new and better healthcare system for tomorrow.
Pre- and Post-COVID-19 Regulations and Rules
The COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, issued in March 2020, have temporarily suspended, relaxed, or postponed a wide range of federal regulations, such as the following:
- Sanctions and violations related to physician self-referral laws
- Three-day inpatient stays prior to discharge to a Skilled Nursing Facility (SNF)
- Additional 100 days of SNF Part A coverage
- The Emergency Medical Treatment and Active Labor Act (EMTALA) requirements
- Temporary Medicare billing privileges
- Expanded acute care bed capacities
- Extended bed classifications and hour limitations for Critical Access Hospitals (CAHs)
- Telehealth restrictions
- Health Information Privacy and Portability Act (HIPAA) provisions
- Physician and non-physician licensing
Check with your state hospital association to determine what emergency declarations impact your healthcare service lines. In order to apply any portion of the blanket waiver, the actions must be applicable to the COVID-19 response and thoroughly documented as necessary.
The blanket waivers include multiple moving parts that still require robust documentation to support the services provided in response to the pandemic. When fulfilling prior payer requirements for complete and compliant documentation, providers may be tempted to relax their guard; however, it would be wise to be cautious and not assume that post-pandemic regulations will bring sweeping changes to healthcare oversight. One thing is certain, the blanket waivers are only temporary, and this current emergency response situation will eventually come to an end.
Additionally, while government and third-party payers are loosening regulatory and policy restrictions to process and pay for COVID-19 tests and services, their claim processing systems require new or modified pass-through procedures, so claims identified as COVID-19-related do not create a backlog. The only way payers can truly assess the impact of COVID-19 on their resources is to request medical records, conduct audits, and thoroughly analyze the COVID-19 documentation and data. Accordingly, providers can expect to see an increase in medical record requests as all payer types assess the delivery and medical necessity of COVID-19 services provided to their beneficiaries. An increase in denials and demands for refunds of overpayments is also to be expected, as services outside the scope of the blanket waiver parameters and/or services that are excessive and non-related to medical necessity may be errors subject to interpretation by insurance auditors and medical reviewers.
It is important to note that all Medicare-enrolled providers who have not yet diagnosed, tested, or cared for probable and/or positive COVID-19 cases, nor have had their patient base or service line impacted by the virus, and/or those who did not seek and/or have not been granted waivers under the 1135 Waiver authority, must continue to operate and comply with the usual and customary Medicare fee-for-service rules. Regulations that govern physician supervision, licensure and scope of practice requirements, telehealth, EMTALA, Stark Law, evaluation and management coding and payment, substance-use-disorder prevention, etc., have not changed for those providers.
- The CMS Waivers and COVID-19 Response document released April 2020 states, “The 1135 Waivers do not allow reimbursement for services otherwise not covered.”
- Medicare Fee-For-Service Additional Emergency and Disaster-Related Policies and Procedures That May Be Implemented Only with a § 1135 Waiver states, “Providers must also resume compliance with normal Medicare fee-for-service rules and regulations as soon as they are able to do so, and in any event, the waivers or modifications a provider was operating under are no longer available after the termination of the emergency period.”
Remember the Old Adage: If It’s Not Documented, It Didn’t Happen
In response to the rapid surge of COVID-19 cases, healthcare organizations have been challenged to stay current with all of the changes applicable to requirements and regulations. Compliance officers have been charged with collecting, organizing, and maintaining documentation that details how COVID-19 has impacted their organizations and service delivery.
Whether your organization is currently caring for active COVID-19 cases, or experiencing some “flattening of the curve” and perhaps entering the recovery phase, Compliance, Health Information, and other support department personnel can help by reviewing scenarios, medical records, and audit samples of documentation to determine any logistical and compliance gaps for later analysis.
While the following list is not exhaustive, it is a starting point that can supplement further guidance from federal, state, and local officials, and support the medical necessity actions and responses necessary to delivering patient care during this crisis.
Areas for immediate attention:
- Ensure accessibility to the complete transcript and application of your organization’s request to operate under the Blanket Waivers. Providers must satisfy all conditions of the waivers in order to receive payment for the designated health services, and the application and approval must be available on request for any State Survey Agency or CMS Regional Office.
- Review your policies and procedures and emergency disaster protocols. Identify any gaps regarding patient screening, staffing levels, media correspondence, clinical care protocols, communication and ethical decision-making, disclosures and protected health information, data security, admission and discharge procedures, etc. Log all actions your organization has taken and continues to take in response to emergency preparedness and disaster protocols, including any deviations from standard and/or normal practices and policies. Prepare to make needed amendments to these documents going forward; document every step taken and all actions required for necessary future updates to any protocols, plans, and documents.
- Establish an ethics committee. Limited, rationed, or non-existent supplies and resources needed to respond to COVID-19 have forced hospitals, health systems, and medical professionals to triage healthcare delivery and make ethical decisions regarding who does and does not receive testing, medication, a bed, a ventilator, and other required care. An ethics committee will help balance those decisions; evaluate resources, staffing, supply and equipment rationing; and provide direction for organizations faced with these agonizing ethical dilemmas. An ethics committee can provide recommendations founded on fact-based criteria to affirm that your organization is doing all it can with the resources it has to save the most lives in your community.
- Document all legitimate but “out-of-the-ordinary” business requirements your organization used to meet the work demands associated with COVID-19, such as offsite screening locations repurposed to expand and expedite access to testing, triage resources rerouted for expected patient influx, etc.
- Conduct an assessment of providers and services, such as new or expanded telehealth and virtual patient care. Include any licensed and/or unlicensed staff, resident and/or teaching physicians brought on board to handle the patient load. Validate providers’ originating state, credentials, and licenses through the National Provider Identifier (NPI) website. Be aware of any inconsistencies in physician licensures and credentialing that may violate your state medical licensing regulations, and work with your State Medical Board to mitigate those inconsistencies.
- Assess and identify any risks related to your organization’s methods and limitations regarding the timely backup and sharing of data and the communication of health conditions of critical patients. Care teams need access to lifesaving information related to chronic conditions, medications, and any existing complications that impact patient care. Data availability, integrity, and accuracy also contribute to the regional, state, federal, and global tracking and trending of the spread of the novel coronavirus.
- Consider extending the saving and storage capabilities of all medical record transcription dictation recordings. Dictation and transcription procedures may be disrupted due to a rush to care for patients. Extending these capabilities allows additional time to retrieve any missing or lost documentation or to access for later dictation review.
- Audit your healthcare service lines for emerging and innovative techniques used by your medical staff to combat the virus. As doctors around the world battle this deadly disease, there has not been time for extensive clinical trials and publication in medical journals. Identify services used to rule out COVID-19 that may not be customary and/or normally approved as “medically necessary” for the symptoms and conditions that patients presented. What standard guidance or protocols were overruled, revamped, or newly developed for the sake of patient care? Categorize and document all relayed or reported communications regarding deviations from protocol and any external communication received or shared with other medical professionals with whom the innovations and interventions were discussed.
- Review HIPAA policies and procedures, and pinpoint access and communication areas where your organization has gaps and room for improvement for ensuring secure communication channels and disclosing to patients when an unsecure connection is used. Look for key areas in concurrent care, transfer of care, patient portal access, and family and caregiver communications through texting and forms of social media. Document any patient communication tools used, such as video and text messages, and confirm you communicated confidentiality and privacy rights with patients. If there were privacy infractions in the midst of the crisis, note them, find a better pathway for the next emergency, and include them in your revised and updated emergency preparedness plan.
- Increase your due diligence and oversight of any technologies that were implemented and integrated into your current workflows to address the influx of patients. Ensure your organization has upgraded any system patches and addressed any vulnerabilities related to technology, processes, and staff information and training.
- Designate one or several Patient Advocates (if your organization does not already have one) who will manage patient inquiries and caregiver communications, as well as coordinate and direct volunteers and donations. Centralizing communications can help caregivers and loved ones feel connected, given that they are generally physically banned from patient care due to necessary COVID-19 social distancing guidelines. Centralizing volunteer and donation activities helps reduce confusion and diverts this workload from the clinical care workers badly needed on the front line.
- Establish and clearly communicate how your organization will respond to media requests. Evaluate and modify any necessary forms of communication for staff to properly report concerns regarding deficiencies and/or lack of resources. Now, more than ever, it is vital that employees are heard, concerns are immediately addressed, and leadership response and actions remain transparent and are communicated back to staff timely. Employees who have factual concerns regarding safety conditions and/or lack of resources at your facility should not face fear of retribution. It is important to foster a culture of honest reporting of concerns and compliance incidents.
- Audit the medical records of suspected and confirmed cases of COVID-19 for accurate diagnosis code application, procedure codes, modifiers, and Place of Service (POS) codes used to capture the full scope of services provided. Identify any abbreviated record entries that may have been used due to the urgency of patient care, and flag those records for any follow-up queries and clarification of acceptable or unacceptable entries; audit for incomplete signatures on documents such as verbal orders, advance directives, discharge and transfer paperwork, post-acute patient choice forms, etc.
- Audit the services of physicians who switched to different roles to handle the COVID-19 patient case load, especially high-risk physicians and those in key leadership roles. Assessing the impact of COVID-19 on your organization’s finances will require an in-depth understanding of gains, losses, and sustainability of your capacities in an emergent situation. Conduct an analysis of physician contract deviations or defaults related to leasing arrangements and compensation losses.
- Develop a process to monitor and alert leadership of any survey or payer requests received regarding your organization’s COVID-19 actions and responses for the next two to five years. It is important to validate each request, conduct a self-audit on the issue or medical record at hand, and prepare an appropriate response.
The swift spread of COVID-19 caught many organizations off-guard. However prepared or unprepared your organization may have been, the goal of emergency preparedness is to have a comprehensive plan to protect patients, secure health information, and stabilize care delivery. Through our COVID-19 Hub, PYA is committed to providing the tools and resources to help you understand and move forward through this pandemic and beyond, maneuver changes brought forth with the 1135 Waivers, and help you look for vulnerabilities and risk in areas that impact patient services and compliance with existing and Blanket Waiver laws and regulations.
For a compliance officer caught up in an emergency, it is important to keep a running list of factors and topics encountered that will later require follow up and thorough vetting. Those details can later be reviewed to determine what issues need to be recorded on the Compliance Work Plan for future audits and improvements. As more federal and state information is released, and medical communities are able to incorporate the COVID-19 guidance, compliance officers and their staff can triage these issues and incorporate the lessons learned from COVID-19 into their compliance work plan, risk analysis, and disaster and emergency preparedness plan and operations.
It will take time to fully understand the implications and flaws now exposed in the healthcare industry and the gaps found within our own organizations in response to this emergency. Sort through the responses, actions, and documentation carefully; draw out the plans for a stronger and more integrated process; and take the necessary steps that will build a foundation for better health and wellness for your community and your organization.
If you have COVID-19 regulatory-compliance-related questions or would like additional pandemic guidance, visit PYA’s COVID-19 hub, or contact one of our PYA executives below at (800) 270-9629.
 Waivers under Section 1135 of the Social Security Act typically end no later than the termination of the emergency period or 60 days from the date the wavier modification was first published. The Secretary of the Department of Health and Human Services can extend the waiver by notice for additional periods up to 60 days, up to the end of the emergency period.