CMS Updates to beneficiary PHE waivers that matter to healthcare compliance
Sharon Parsley, JD, MBA, CHC, CHRC, contributes regularly to the YouCompli blog. In this article, she discusses several issues that hospitals and health systems need to consider as a result of the scheduled end of the COVID-19 public health emergency.
The U.S. Department of Health & Human Services (HHS) reports that 80% of the U.S. population previously received at least one COVID-19 vaccination. HHS also advises that daily COVID-19 cases are down 92%, and that COVID-19 related deaths are down more than 80% since the peak of the January 2022 Omicron variant surge.
As a result, the COVID-19 public health emergency (PHE) declared under Section 319 of the Public Health Service act, is expected to end officially on May 11, 2023. HHS made this announcement on February 9, 2023, along with the publication of a transition roadmap.
During the PHE, the Centers for Medicare and Medicaid Services (CMS) relied on emergency authorizations, waiver authorities, regulatory processes, and sub-regulatory guidance to create numerous waivers and flexibilities. These were designed to expand access to care and to create additional healthcare capacity to optimize care for COVID-19 positive patients. CMS has also issued guidance detailing which waivers and flexibilities will continue and those that will end with the expected end of the PHE.
The remainder of this article will summarize the waivers that hospitals and health systems should be mindful of and address. (Find the details here: Hospitals and CAHs (including Swing Beds, DPUs), ASCs and CMHCs: CMS Flexibilities to Fight COVID-19. Finally, note that these issues are specific to Medicare and Medicaid beneficiary patients only.
PHE Waivers Ending in May 2023
The following waivers will end in May 2023:
- The waiver of the requirement for a medically necessary 3-day prior inpatient hospitalization for Medicare coverage of a skilled nursing stay.
- Blanket waivers of various provisions of the Stark Law for financial relationships and referrals directly related to the COVID-19 PHE. As a result, all health entities and physicians will be expected to unwind or restructure any relationship that doesn’t fully comply with an applicable Stark Law exception.
- The “hospitals without walls” waiver, which enabled hospitals to provide bed and board, nursing and other hospital services at hotels, malls, and other community facilities.
- The waiver permitting hospitals to create new or relocate existing provider-based departments (PBD) without regard to applicable Conditions of Participation (CoPs) and PBD requirements. Additionally, the “extraordinary circumstances” PBD relocation policy established in May 2020 will end. The expectation is that most PBDs that relocated during the PHE will return to their original locations.
- Many waivers of CoPs requirements will end. Those include:
- Flexibilities regarding detailed discharge planning requirements.
- Allowing a 48-hour period to authenticate verbal orders.
- Allowing up to 30 days post-discharge to complete medical records.
- Waiver of the requirement that a hospital has an approved utilization review (UR) plan and a UR committee to evaluate admission and services, medical necessity and length of stay.
- Flexibility allowing used face masks to be removed and reused in sterile processing compounding areas.
- Waivers of certain quality assessment and performance improvement (QAPI) program requirements.
- Flexibilities regarding patient-specific nursing care plans.
- Waivers about facility policies and procedures for outpatient departments not requiring the continuous presence of a registered nurse.
- Allowing Medicare inpatients to be under the care of a physician’s assistant or nurse practitioner (rather than a physician).
- Permitting physicians whose privileges would have expired and new physicians to practice prior to full medical staff and board approval.
- Flexibilities in federal requirements for minimum personnel qualifications for clinical nurse specialists, nurse practitioners, and physician assistants.
- Flexibilities about written designation of personnel authorized to perform respiratory care procedures and how those services are supervised.
- Waivers relating to emergency preparedness plans and therapeutic diet manuals for surge capacity sites.
- Flexibilities permitting hospitals to establish offsite community COVID-19 screening locations.
- Flexibilities that allowed select hospital employed professionals to provide infusions, wound care, behavioral health care and education services, including partial hospitalization, to Medicare beneficiaries in their homes.
- A waiver that permitted a hospital to register beds as skilled nursing swing beds for Medicare patients needing a step down from acute care to a skilled nursing bed.
- Waivers of certain requirements that permitted acute care hospitals to bed inpatients in excluded distinct part units (DPU). Conversely, waivers allowing hospitals to place inpatient psychiatric and inpatient rehabilitation patients who would normally be admitted to a DPU in an acute care bed unit will also end.
- Additional payments for approved drugs and biologicals to treat COVID-19 in a hospital outpatient setting during the PHE will be packaged into the primary Comprehensive Ambulatory Payment Classification payment. After the PHE, no separate payment will be made.
- Payment for temporary HCPCS code C9803 (hospital outpatient clinic visit specimen collection for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) (coronavirus disease [covid-19], any specimen source).
- Each Medicare Administrative contractor will have discretion about coverage of FDA authorized COVID-19 diagnostic serology testing.
- Certain waivers of eligibility requirements for sole community hospitals and Medicare-Dependent Small Rural hospitals.
PHE Waivers that Last Beyond May 2023
The end of the PHE doesn’t mean the end of all waivers. Here are some that survive, at least for a while:
- Many telehealth flexibilities have been extended through December 31, 2024, pursuant to the Consolidated Appropriations Act of 2023.
- Payments for COVID-19 vaccinations administered to Medicare beneficiaries in outpatient settings will continue to be approximately $40 per dose. These payments are tied to the end of the emergency use authorization (EUA) for COVID-19 drugs and biologicals.
- Payment for vaccinations administered in a Medicare beneficiaries’ home will remain at approximately $76. This amount will be adjusted annually and is not tied to the end of the PHE.
- Pursuant to section 3710 of the CARES Act, enhanced payments to hospitals for the care of eligible inpatients requiring products authorized to treat COVID-19 will end at the end of the fiscal year in which the PHE ends.
- Medicaid programs will continue to cover COVID-19 testing without a patient cost-sharing obligation until at least September 30, 2024.
- Hospitals’ COVID-19 data reporting requirements will continue through April 30, 2024; however, the reporting frequency is likely to change.
- Rulemaking will occur to adjust policies which currently allow DEA-registered practitioners to dispense controlled substances via telemedicine with no prior face-to-face encounter.
Recommendations and Next Steps
Obviously, hospitals are facing a LOT of regulatory change as they unwind all these waivers quickly. While in some cases you and your colleagues are reverting to business as usual, many of your colleagues may barely remember pre-pandemic practices.
If you have a joint commission readiness team, work with them to tackle the CoPs waivers and come up with a game plan to address each applicable issue. Look to your internal compliance committee to take on some or all other waivers. They can also help you identify individuals best able to create and implement action plans for those that require attention.
Your operational colleagues should be prepared to address the waivers tied to specific service lines.
Regardless of approach, compliance needs to be at the table to support, assist, and advise on how to efficiently deal with the policy, process, contractual, and operational changes that may be necessitated by the end of these waivers.
Related: Wondering how to get your seat at the table? Check out Lisa Herota’s article, Transforming Compliance to a Department of Yes
This summary is not a comprehensive analysis of every waiver or flexibility change for hospitals, but it does give you a sense of some of the most critical waivers to watch for. Be sure to review the fact sheets I linked to from CMS. If your organization is not a hospital or healthcare system, be sure to review the CMS guidance for other provider types.
Sharon Parsley, JD, MBA, CHC, CHRC, is a health law attorney, compliance officer, author, speaker, investigator, and problem solver. She currently serves as the president and managing director of Quest Advisory Group, LLC. She has nearly 20 years of healthcare compliance and legal leadership experience, and she believes that mentorship and on-the-job training are critical to compliance professional success.
Help Working with Operations
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