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Section 1135 Waivers: “Patients Over Paperwork” Does Not Mean NO Paperwork

Leyla Erkan, Director Global Healthcare Compliance Lead
Rebecca Nilson, Director Enterprise Risk Management Healthcare Lead

On March 13, 2020, President Trump declared a national emergency in response to the COVID-19 pandemic, enabling the Secretary of the U.S. Department of Health and Human Services to temporarily suspend, modify and give flexibilities (authorized under Section 1135 of the Social Security Act) for certain federal requirements related to the Medicare conditions of participation, state Medicaid plans, including the Children’s Health Insurance Program, and the Health Insurance Portability and Accountability Act. The Section 1135 Waivers (“Waivers”) assist states, healthcare providers and durable medical equipment suppliers in dealing with the response to a disaster by ensuring that sufficient health care items and services are available to meet the needs of patients.

Patients Over Paperwork

The “Patients Over Paperwork” initiative was designed to ease the administrative burden on providers and give more time to patient care. The following are examples of some of the Waivers flexibilities: licensure and enrollment requirements, time constraints for updating content of medical records, signature requirements, Stark regulatory burdens, documentation to prescribe respiratory devices, signatures for durable medical equipment and Medicare Part B drugs. Although there are a number of regulatory flexibilities allowed during this time of crisis, the Centers for Medicare & Medicaid Service (CMS) has indicated that providers should not abandon documentation altogether and must maintain sufficient supporting documentation to justify the reliance on or use of the Waivers.

Documentation Examples

The Office of Inspector General (OIG) has said that the Waivers may limit sanctions under the Stark law provided that organizations maintain sufficient documentation of why the Waivers were utilized and the timeframe in which they were in place. Additionally, the CMS is allowing durable medical equipment Medicare Administrative Contractors (MACs) to have the flexibility to waive equipment replacement requirements, including the need for a face-to-face visit, a new physician’s order, and new medical necessity documentation. However, suppliers must still document the reason why the equipment must be replaced and state why it was lost, destroyed, irreparably damaged or otherwise rendered unusable or unavailable. Further, Waivers intended to expand capacity may effectively require more documentation to justify place of service billing designations. Another example is that in order to implement the telehealth flexibilities and increased reimbursements, the American Medical Association advises that documentation via telehealth must meet the documentation standards for the service provided and associated CPT codes as if it were in person, including documented patient consent.

In any of these examples, appropriate documentation will be critical to ensure that providers and suppliers receive proper payment as well as avoid regulatory scrutiny while operating under these Waivers. The CMS and other regulatory bodies may audit and review practices during and immediately following the pandemic to ensure that original regulations are being followed. Routine monitoring will assist with compliance efforts.

Time is of the essence, and documenting actions and temporary procedures while memories are still fresh are essential to recording actions the organization has taken during the crisis.

Here are six key actions that can be taken to help maintain proper documentation and tell a meaningful COVID-19 story:

  1. Document the overall COVID-19 response plan now or as soon as possible to ensure it captures all actions taken by the organization. (To learn more about the information to be maintained and critical success factors, see the Protiviti blog post FEMA Funding $$$$ Beginning With the End in Mind: COVID-19 Efforts).
  2. Confirm that the organization’s COVID-19 response committee or task force includes members from the compliance, internal audit and legal teams to ensure the appropriate interpretation of the Waivers (for example, federal licensure flexibilities might not align with state licensure requirements) and the necessary controls are in place.
  3. Track the 1135 Waivers and those that are utilized. Include an explanation of why standard compliance with regulations cannot be carried out during this period, temporary protocols to meet the relaxed requirements, time frames and a communications plan for how to ensure that they are operationalized. For instance, OIG has announced that anti-kickback regulation modifications began April 3, 2020, unlike the CMS Stark blanket waiver guidance of March 1, 2020. CMS updates its Waivers frequently, so visit the CMS website daily.
  4. Determine whether any Waivers that are outside of the blanket Waivers are needed and document why. Contact the CMS as soon as possible to obtain approval for the special waiver 1135 Waiver Requests.
  5. Set up flags within electronic health records for those cases related to COVID-19 to ensure review of proper documentation and coding. Many organizations have instituted billing holds as well as second and even third levels of review prior to billing.
  6. Explain the process and dates for discontinuing the Waivers when the pandemic is deemed over, or the time limit for a specific waiver expires. For instance, the waiver related to certain HIPAA requirements lasts for up to 72 hours from the time the hospital implements its disaster protocol.

For more information about Section 1135 Waivers, listen to our recent webinar.

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