Question 10 (for DMEPOS providers): Did you take advantage of waivers to the DMEPOS replacement requirements, Medicare Part B and DME signature requirements, or other state-level DMEPOS flexibilities?
Question 11 (for Medicare Diabetes Prevention Program participants): Did you take advantage of waivers for in-person attendance to first core sessions, limits on virtual services, or once-per-lifetime limits?
On Jan. 30, 2023, President Joe Biden announced that the COVID-19 public health emergency (PHE) will end May 11, 2023. Under the PHE, the federal government implemented a range of modifications and waivers impacting Medicare, Medicaid and private insurance requirements, as well as numerous other programs, to provide relief to healthcare providers. Legislation passed by Congress — including the Coronavirus Aid, Relief, and Economic Security (CARES) Act and the Families First Coronavirus Response Act — provided additional flexibilities tied to the PHE. The PHE’s expiration after more than three years brings an end to these flexibilities and waivers and creates various questions for the healthcare industry.
This article addresses 12 frequently asked questions that concern many healthcare providers and includes guidance for navigating these changes.
Question 1: Did you receive any COVID-19-related funding from the federal government (e.g., Provider Relief Fund, PPP Loans, Medicare Accelerated and Advance Payments)?
A. Was any of your COVID-19-related funding from the HRSA Provider Relief Fund (PRF)?
Most healthcare providers received PRF funding (as described in greater detail in a previous McGuireWoods client alert) from the Health Resources and Services Administration (HRSA). These payments during the COVID-19 pandemic were intended to maintain the nation’s health system capacity. The PRF was provided in various phases and payment rounds, including automatic payments in April 2020. Thereafter, providers typically applied for funding. The payments were available for eligible providers who diagnosed, tested or cared for individuals with possible or actual cases of COVID-19 and had healthcare-related expenses and lost revenues attributable to COVID-19. PRF recipients were required to use payments for eligible expenses — including lost revenues — during the period of availability (beginning Jan. 1, 2020, and running at least a year from receipt) but only up to the end of the PHE.
For those that received PRF funding exceeding $10,000 in the aggregate during an applicable period, HRSA requires reporting through the reporting portal. The fourth reporting period, for those who received funding in the second half of 2021, closed March 31, 2023. Reporting for periods 5-9 — for those that received funding in 2022, 2023 or 2024 — will open in the future. Providers should monitor these deadlines and ensure they are ready to provide the required information to HRSA, as discussed in McGuireWoods’ Provider Relief Fund reporting page.
HRSA also updated the availability for expending eligible expenses with the end of the PHE on May 11, 2023, allowing the funds to be used for eligible expenses on a rolling basis through June 30, 2025, depending on date of receipt; i.e., HRSA is allowing funding received in 2022 or 2023 to be spent past May 11, 2023, for eligible exceptions. This, however, will not apply for lost revenue, which can be reported only through June 30, 2023. Thus, any provider that has received PRF payments after Jan. 1, 2022, should track eligible expenses, report lost revenues only through June 30, and otherwise return unspent funds.
Additionally, with the end of the PHE, providers should take the following actions: (1) maintain all records of payment and reporting regarding COVID-19-related purposes in preparation for a future audit; (2) engage an external auditor for program-required audits if they received more than $750,000 from the PRF during an applicable period (and ask an experienced auditor if such an audit is required if there are questions about affiliated entities or multiple years of received funds); and (3) take further action if they are missing records or failed to report during any previous period.
B. Was any of your COVID-19-related funding a loan from the Paycheck Protection Program (PPP)?
The U.S. Small Business Administration-backed PPP loans (as described in greater detail in a previous McGuireWoods client alert) were distributed to help small businesses and certain other entities maintain an employed workforce during the COVID-19 pandemic. To be eligible for a PPP loan, an applicant must have been a small business, sole proprietor, independent contractor, self-employed person, 501(c)(3) nonprofit organization, 501(c)(19) veterans’ organization or a tribal business.
Under specific circumstances, a business that received a PPP loan was granted the opportunity to receive a second draw PPP loan. Borrowers are eligible for PPP loan forgiveness if the proceeds were used for eligible expenses. Applications for PPP loan forgiveness may be submitted once all loan proceeds for which the borrower is requesting forgiveness have been used and before the maturity date of the loan. However, if a borrower has not applied for loan forgiveness within 10 months after the last day of the covered period, the borrower must begin making payments on the loan.
With the PHE sunsetting on May 11, 2023, providers should consider taking the following actions: (1) confirm that any applications for PPP loan forgiveness have been accepted by the applicable bank or, if they are eligible and have not yet applied, apply for loan forgiveness; and (2) maintain all records of application, payment and loan forgiveness in preparation for future audits. In addition, as the government has commenced investigations and prosecution of PPP fraud (as discussed in further detail in a previous McGuireWoods client alert), providers also should retain supporting materials that demonstrate compliance with the PPP terms and conditions, including support for employees on their payroll, records showing how the funds were used and evidence supporting the accuracy of their applications. To the extent any such documentation is missing, providers should supplement their records before the end of the PHE as a contemporaneous record.
C. Was any of your COVID-19-related funding a loan from the Medicare Accelerated and Advance Payments (AAP) Program?
On March 28, 2020, the Centers for Medicare & Medicaid Services (CMS) expanded its Medicare Accelerated and Advance Payments (AAP) Program to allow most Medicare Part A and Part B providers and suppliers to request an advance of up to 100% (or more) of such provider’s Medicare payments over a three- or six-month period. CMS expanded its standard AAP to offer healthcare providers and suppliers critical liquidity to help with cash-flow issues because of postponement in nonessential surgeries and procedures, staffing challenges and disruption in billing related to the COVID-19 pandemic. However (as discussed in a previous McGuireWoods legal alert), on April 26, 2020, CMS announced it was immediately suspending its AAP to Part B suppliers and reevaluating the amounts to be paid to Part A providers under the AAP, including hospitals.
Payments under the AAP are not grants, so providers and suppliers must repay the amounts they received. Recoupment automatically began one year after the issuance of AAP from the applicable Medicare administrative contractors (MACs), as displayed in the graphic to the right. Once recoupment began, until the amount received under the AAP program was repaid in full, a provider’s or supplier’s Medicare fee-for-service reimbursement was reduced for 17 months (percentages are included in graphic to the right). If the provider or supplier did not fully repay the AAP funding it received by the end of the 17-month recoupment period, the MAC could issue a demand letter for full repayment of any remaining balance, subject to an interest rate of 4%. The AAP allows an extended repayment schedule (ERS), upon request to and approval of the MAC for “hardships.”
At this point, most Medicare providers and suppliers participating in the AAP (with the exception of a Part A provider who applied after April 26, 2020, or any provider/supplier who was approved for a hardship ERS), should have fully repaid these payments or the MAC should have demanded repayment.
Providers and suppliers should ensure that they have evidence from the MAC that the advances were fully repaid (either through the automatic reimbursement reductions or from payment in response to a demand). Further, the government has been taking action to investigate and prosecute misuse of AAP funds, so providers and suppliers should maintain their AAP application and history of accounting for provider- or supplier-related expenses. Healthcare providers and suppliers also should maintain records related to the impact of COVID-19 on their business to show how the AAP was obtained in response to the PHE.
Question 2: Did you take advantage of any COVID-19-related tax or benefits changes?
A number of tax- and benefits-related initiatives were implemented in response to the COVID-19 pandemic. While many of these initiatives have expired or are no longer active, the expiration of the PHE on May 11, 2023, will affect various COVID-19-related employee benefits changes.
Individual Deadline Extensions and Plan Deadline Extensions
During the PHE, various deadlines applicable to individual employees/former employees were tolled, including deadlines for: (1) electing COBRA and making COBRA premium payments, (2) submitting claims and appeals, (3) requesting and providing information for external review, (4) notifying a plan of a qualifying event or disability, and (5) requesting special enrollment.
This guidance, put in place pursuant to the Department of Labor Employee Benefit Security Administration Disaster Relief Notice 2021-01, was set to last the earlier of one year or until 60 days after the end of the PHE. With the expiration of the PHE on May 11, 2023, tolling will end July 10, 2023. For example, if a qualified beneficiary’s COBRA election deadline was July 1, 2022, the election requirement would have tolled to June 30, 2023, the maximum one-year delay. However, if a qualified beneficiary’s COBRA election deadline was Sep. 1, 2022, the election requirement will be tolled only until July 10, 2023, 60 days after the end of the PHE. In a meeting with the Internal Revenue Service and Department of Labor on Feb. 10, 2023, government representatives noted that they likely would issue additional benefits-related guidance for plan sponsors as the end of the PHE approaches.
COVID-19 Testing and Vaccine Coverage Requirements
The Families First Coronavirus Response Act required all public and private insurance, including employer-sponsored group health plans, to cover COVID-19 tests and the costs associated with diagnostic testing with no beneficiary cost-sharing while the PHE remained in effect. The CARES Act expanded this initiative to require coverage for out-of-network tests for the duration of the PHE. The Consolidated Appropriations Act of 2021 took this one step further and applied the expanded obligations to over-the-counter COVID-19 testing, requiring coverage for up to eight free over-the-counter at-home tests per covered individual per month.
The expiration of the PHE will terminate this requirement for health plans to cover COVID-19 tests, both diagnostic and over-the-counter, or testing-related services with no cost-sharing.
The end of the PHE likely will not create many significant coverage changes for the COVID-19 vaccine, as various federal laws, including the Affordable Care Act (ACA), the Inflation Reduction Act and other pandemic-era measures require insurers to cover COVID-19 vaccinations as preventative care. However, whereas currently employer group health plans must cover COVID-19 vaccines without cost-sharing for both in-network and out-of-network vaccines, once the PHE ends, plans will be able to implement cost-sharing or no coverage policies for out-of-network vaccines.
Further, the Department of Health and Human Services (HHS) has stated that the end of the PHE will not affect the Food and Drug Administration’s (FDA’s) ability to authorize various COVID-19-related tests, treatments or vaccines for emergency use. Vaccines and treatments that currently exist under emergency use authorizations will remain in effect under the Federal Food, Drug and Cosmetic Act, and the FDA will continue to be authorized to issue new emergency use authorizations when certain criteria for such issuances are met.
Providers should ensure they have up-to-date information on how to appropriately administer their own benefit plans for current and former employees and should assess insurance contracts to ensure up-to-date information regarding coverage for COVID-19-related tests, treatment and vaccines.
McGuireWoods’ employee benefits team plans to provide more targeted guidance and specific considerations related to the PHE’s expiration and the impact on employee benefits as more specific information is released.
Question 3: Did you structure any relationships with physicians or other clinicians that utilized a Stark Law or Anti-Kickback Statute waiver?
At the onset of the PHE, CMS issued blanket waivers to permit certain financial relationships and referrals that, in the absence of such waivers, would violate the Stark Law. The HHS Office of Inspector General followed with a policy announcement providing enforcement discretion with respect to the Anti-Kickback Statute (AKS). Such waivers included, for example, that arrangements did not need to be in writing or signed (expecting the pandemic would make such administrative necessities overly burdensome) and removed the location requirements for the in-office ancillary services exception to the Stark Law. The blanket waivers were available to protect specific financial relationships and referrals with at least one enumerated COVID-19 purpose.
For the blanket waivers to apply, various conditions had to be met, including that (1) providers must act in good faith to provide care in response to the COVID-19 pandemic, (2) the government does not determine that the financial relationship creates fraud and abuse concerns, and (3) providers seeking protection under the blanket waivers must maintain sufficient documentation. These blanket waivers will terminate when the PHE ends on May 11, 2023.
Pending the end of the PHE, providers should perform a compliance review of their various arrangements under both the Stark Law and AKS. If an arrangement was put in place pursuant to a blanket waiver, providers must first determine whether the blanket waiver relationship will continue.
Based on that determination, there are two courses of action.
- If the relationship will continue, providers should work with counsel to ensure the arrangement will meet all applicable elements of Stark Law exceptions or AKS safe harbors absent the blanket waivers. For example, if a provider is doing business without a written agreement or if payments exceeded fair market value, providers should document the financial arrangement in a signed writing and payments should be reduced to the fair market value to meet certain Stark Law exceptions. Because blanket waiver flexibilities will no longer exist upon the end of the PHE, providers should begin to examine their policies, procedures and financial relationships to ensure they are in compliance under a general Stark Law exception or AKS safe harbor after the PHE.
- If providers utilizing the blanket waivers determine the current financial relationship should be terminated, providers need to (1) terminate all financial relationships permitted under the blanket waivers and (2) return all items (but not necessarily payments) provided pursuant to the arrangement (i.e., computer equipment for remote services) during this time as a result of one of the approved blanket waivers (otherwise, the relationship may be deemed to continue with the given item). Consider documenting such termination of such relationships in writing as of the earlier of a specific date when the relationship ended or May 11, 2023.
Regardless of whether the financial arrangements commenced pursuant to the blanket waivers will continue, providers should ensure the existence of appropriate documentation for any arrangement entered into during the pendency of the PHE. Such documentation should describe the providers’ appropriate COVID-19 purpose, specify which approved blanket waiver the provider utilized and, ideally, document the specific terms of the arrangement. Records relating to the blanket waivers will need to be provided to HHS or CMS upon request.
Question 4: Did you establish additional locations or service lines during the PHE that targeted COVID-19 treatment or vaccinations?
The HHS Public Readiness and Emergency Preparedness (PREP) Act created liability protections for manufacturers, distributors and administrators of drugs and devices that are used to treat COVID-19. This liability shield will extend past the end of the PHE until Oct. 1, 2024, or until HHS rescinds the PREP Act. This liability protection is not ironclad, but many providers expanded their services understanding they would have this additional protection. Providers should reevaluate their liability protections for any treatment locations they added, considering the end of the PHE, to determine if they will continue to rely on the PREP Act or phase out such locations.
Due to the PREP Act, “qualified persons” were able to prescribe and/or administer COVID-19 vaccines and countermeasures during the PHE with theoretical protection from liability for malpractice claims (except for willful misconduct). Qualified persons included students in approved healthcare practitioner programs, government employees and other healthcare professionals such as dentists, optometrists and pharmacists, among others. The PREP Act will not expire until Oct. 1, 2024, or until HHS rescinds the PREP Act, allowing qualified persons to continue prescribing and administering COVID-19 vaccines and medications once the PHE ends, with some ability to have malpractice protections. Of course, with the end of the PHE, that shield may not be as strong as it once was. Further, providers should ensure they record who assisted them to ensure the best protection under the PREP Act.
Separately, on April 18, 2023, HHS announced the Bridge Access Program For COVID-19 Vaccines and Treatments (BAP) that leverages public-private partnerships to maintain access to COVID-19 vaccines and treatment for the public after the end of the PHE. Specifically, the BAP provides support for the existing public sector vaccine safety net through local health departments and facilities supported by HRSA such as federally qualified health centers (FQHCs). The BAP also allocates $1.1 billion of funding toward creating and maintaining public-partnerships with pharmacy chains that would enable such pharmacies to continue providing certain individuals with free COVID-19 vaccinations and treatments after the PHE sunsets.
Reimbursement for COVID-19 Vaccines and Treatment:
Such locations also may be impacted by changes to reimbursement. During the PHE, Medicare Parts A and B and Medicare Advantage beneficiaries paid no cost-sharing for certain COVID-19 treatments. Similarly, private insurance beneficiaries did not have to pay for certain COVID-19 treatments because the federal government provided some treatments, such as antiretrovirals, to providers free of charge. When the PHE ends, the government will stop COVID-19 treatment coverage. As a result, COVID-19 treatment coverage for Medicare beneficiaries will extend only to costs for oral antiviral drugs, such as Paxlovid.
Until Sep. 30, 2024, Medicaid programs will cover COVID-19 treatments without cost-sharing. After Sep. 30, 2024, Medicaid coverage for COVID-19 treatments will vary dependent on individual state decisions to continue coverage for certain COVID-19-related treatments.
Additionally, private insurance coverage may change. Under the PHE, private insurance companies were required to cover the cost of COVID-19 vaccines and lab tests without cost-sharing. While this requirement will end, as discussed in response to Question 2 above, many private insurance plans likely will continue offering COVID-19 vaccines at no cost. COVID-19 lab tests ordered by a provider will still be considered an essential health benefit under the ACA, but private insurers likely will implement cost-sharing and coverage limitations (e.g., only through in-network providers). Providers should be aware that coverage of COVID-19 vaccines, lab tests and treatment will vary under private insurance plans at the conclusion of the PHE.
Question 5: Did you shift services to remote telehealth or remote patient monitoring?
During the pandemic, HHS took steps to enable easier implementation of telehealth services. After the PHE comes to an end, many of the flexibilities HHS established will remain in place, either permanently or temporarily.
Permanent changes for behavioral (and through 2024 for other services)
- Telehealth services provided at home will remain covered by Medicare. During the PHE, HHS expanded the definition of “originating site” to include “any site in the United States at which the eligible telehealth individual is located at the time the service is furnished … including the home of an individual.” This definition of originating site expanded Medicare coverage for at-home telehealth services because Medicare coverage for telehealth services previously was limited to patients at hospitals and other healthcare provider facilities. After the PHE ends, Medicare patients can permanently receive covered behavioral and mental telehealth services in their home. For nonbehavioral services, Medicare patients will be eligible to receive certain telehealth services until Dec. 31, 2024.
- Medicare coverage for audio-only telehealth will remain available. During the pandemic, HHS allowed Medicare coverage for audio-only telehealth services. After the PHE, behavioral and mental audio-only telehealth services will permanently be covered by Medicare. For nonbehavioral telehealth services, certain audio-only services will be covered by Medicare through Dec. 31, 2024.
- FQHCs and rural health clinics (RHCs) can serve as distant site providers. Prior to the PHE, FQHCs and RHCs could serve only as an originating site for telehealth services. During the pandemic, though, these facilities’ ability to offer telehealth services was expanded to allow FQHCs and RHCs to serve as distant sites as well. After the PHE, FQHCs and RHCs will remain eligible to serve as distant site providers for behavioral and mental health services. For nonbehavioral telehealth services, FQHCs and RHCs will be able to serve as distant site providers until Dec. 31, 2024.
- The Drug Enforcement Administration (DEA) proposed rules for online prescribing of controlled medications. On Feb. 24, 2023, DEA announced a proposed rule for online prescribing of controlled substances via telemedicine. During the PHE, DEA-registered practitioners in all areas of the United States could issue prescriptions for Schedule II-V controlled substances to patients for whom they had not conducted an in-person medical evaluation. DEA’s proposed rule significantly limits this ability for online prescribing of controlled substances to again require an in-person visit, subject to limited exceptions. For consultations without an in-person exam, the proposed rule would allow the medical practitioner to prescribe a 30-day supply of Schedule III-V non-narcotic controlled medications and a 30-day supply of buprenorphine for the treatment of opioid use disorder. If the patient requires a Schedule II medication or a Schedule III-V narcotic, an initial in-person exam would be required before any prescription could be issued. Otherwise, an in-person evaluation or referral would be required.
- The expanded list of telehealth practitioners who can provide Medicare-covered telehealth services will remain in effect until Dec. 31, 2024. Prior to the PHE, only physicians, nurse practitioners, physician assistants and other specified providers could provide telehealth services that would be covered by Medicare. During the PHE, the list of approved telehealth practitioners was expanded to include occupational therapists, physical therapists, speech language pathologists and audiologists. The expanded list of telehealth practitioners will remain in effect until Dec. 31, 2024.
- The in-person requirement for telehealth mental health services once again will be in effect as of Dec. 31, 2024. In November 2021, CMS released a final rule as part of the 2022 physician fee schedule requiring an in-person visit within six months of the first telehealth service and one in-person visit every 12 months thereafter for Medicare coverage of telehealth mental health services. After pushback, this requirement was delayed by the Consolidated Appropriations Act of 2022. This in-person visit requirement for telehealth services will be reinstated, however, after Dec. 31, 2024. After this date, an in-person visit will be required within six months of the initial behavioral or mental telehealth service and every 12 months thereafter.
- The relaxed HIPAA regulations will be in effect until the end of the PHE. During the PHE, the Office for Civil Rights (OCR) announced that it would exercise its discretion in enforcing HIPAA, and it would not impose penalties for HIPAA noncompliance in connection with providing telehealth services. Until the PHE ends, providers can use any nonpublic-facing application for Medicare-covered client communications regardless of whether such application is HIPAA-compliant. After the PHE comes to an end, healthcare providers once again will be required to use HIPAA-compliant telehealth applications and vendors to offer telehealth services.
Providers engaged in telehealth services should evaluate their telehealth practices in light of the current regulations and should continue to monitor telehealth regulations to ensure such services are provided appropriately. Importantly, effective at the end of the PHE, technology used to provide telehealth visits will need to comply with prepandemic standards. For more information on these changes with respect to HIPAA, please see this earlier McGuireWoods alert.
Question 6: Did you open any Hospitals Without Walls programs during the PHE?
At the onset of the PHE, CMS provided significant flexibilities to allow hospitals to provide hospital services in other hospitals and sites that otherwise would not have been considered part of a healthcare facility, or to set up temporary expansion sites to help address the urgent need to increase capacity to care for patients. This enabled hospitals to create surge capacity by allowing them to provide room and board, nursing and other hospital services at remote locations such as hotels or community facilities. CMS also permitted ambulatory surgery centers (ASCs) to contract with local hospitals and healthcare systems to provide surge capacity or to temporarily enroll in Medicare as hospitals during the pandemic.
When the PHE expires on May 11, 2023, the flexibilities offered to hospitals to provide services in these temporary expansion locations will end, and hospitals will be required to provide services only in hospital locations and departments that meet the hospital (or critical access hospital, as applicable) conditions of participation.
Hospitals should act now to identify any temporary expansion sites and locations still in operation and make plans to relocate the services from those locations to the main hospital or existing provider-based departments. Alternatively, hospitals can consider whether temporary expansion sites could be converted into provider-based departments, which would require compliance with the conditions of participation and the provider-based rules at 42 C.F.R. § 413.65.
ASCs and Free-Standing Emergency Departments Temporarily Enrolled as Hospitals
As part of the Hospitals Without Walls initiative, CMS permitted Medicare-certified ASCs to temporarily reenroll as hospitals to provide hospital services and address the need for capacity in general acute care hospitals to take care of COVID-19 and other patients. Independent, free-standing emergency departments (FSEDs) also were permitted to temporarily enroll as hospitals during the PHE. CMS stopped accepting requests from ASCs and FSEDs to temporarily enroll as hospitals in December 2021.
When the PHE expires on May 11, 2023, the temporary certification of ASCs and FSEDs as hospitals will be terminated, and FSEDs will no longer be able to bill Medicare as hospitals. An ASC may decide to seek certification as a hospital if the ASC can meet the hospital conditions of participation. If an ASC wishes to seek Medicare certification as a hospital, it should submit an initial CMS-855A enrollment application and must be surveyed by a state agency or CMS-approved accrediting organization. ASCs temporarily enrolled as hospitals that plan to convert back to ASC status must submit a notification of intent to convert back to an ASC to the applicable CMS Survey and Operations Group location on or before the conclusion of the PHE via email or mailed letter and must come back into compliance with the ASC conditions for coverage.
ASCs seeking Medicare certification as hospitals should act now to start the enrollment and certification process before the PHE ends. ASCs temporarily enrolled as hospitals that plan to convert back to ASC status should notify CMS prior to May 11, 2023, of their intent to do so.
Question 7: Did you take advantage of any supervision waivers with respect to “incident to” billing, radiology or diagnostic supervision?
During the PHE, CMS modified the definition of “direct supervision” to include a virtual presence via interactive telecommunications technology for purposes of “incident to” billing rules. “Incident to” billing is a Medicare billing provision that allows services furnished in an outpatient setting by a nonphysician practitioner (NPP) to be billed at 100% of the physician fee schedule provided that the physician conducts the initial encounter and the NPP care is rendered under the “direct supervision” of the physician. This telecommunication modification gave flexibility to providers submitting claims under these rules.
The revised supervision rules will remain in effect until the last day of the calendar year in which the PHE ends (currently Dec. 31, 2023), after which the direct supervision requirement for incident to billing will require the physician’s presence in the office while an NPP is providing the services.
As for radiology, CMS allowed the supervising physician or NPP — where allowed by state law and state scope of practice — to virtually oversee Level 2 diagnostic tests using contrast media by way of audio/visual real-time communications. This supervision expansion loosened the pre-PHE direct supervision requirement. In its 2023 final rule, CMS indicated it will continue gathering information and evidence on the PHE direct supervision expansion. Importantly, CMS noted that the virtual supervision expansion may become permanent for radiology.
Regardless of whether the context is “incident to” billing or radiology, CMS has not made the direct supervision waiver permanent. Consequently, prior to the end of the PHE, providers utilizing the direct supervision waiver should begin making arrangements to ensure the physician is present and immediately available to an NPP if the NPP will bill radiology services or bill services incident to the physician.
Question 8: Did you report on COVID-19-related diagnoses to the CDC, HHS or other federal agencies?
During the pandemic, the federal government took measures to expand patient access to vaccinations and COVID-19-related lab tests and to institute COVID-19 data surveillance. HHS was granted the authority to require COVID-19-related reporting, which allowed the Centers for Disease Control and Prevention (CDC) to collect COVID-19 lab results and immunization information that could then be used to calculate the percent positivity for COVID-19 tests. As the PHE comes to an end, providers should be aware of the resulting changes related to reporting of COVID-19 vaccinations and testing.
With respect to lab reports, the required reporting of COVID-19 lab results and immunization data to the CDC will change when the PHE ends. Most notably, HHS will no longer have the authority to require labs to provide COVID-19 lab test reports, but hospital reporting requirements will still apply as a CMS condition of participation until April 30, 2024. The CDC is working with various jurisdictions to continue vaccine reporting under voluntary data use agreements, and some states similarly required this, so providers should check the specific go-forward reporting requirements in their jurisdiction.
Question 9: Did you take advantage of any state-based waivers including with respect to out-of-state providers, facility waivers, the HIPAA Privacy Rule or other COVID-19-related supports?
Many states implemented waivers granting licensure flexibility that allowed out-of-state providers to practice within certain facilities in their state for reasons relating to the COVID-19 pandemic. For example, some states allowed physicians with active licenses in other states to practice in their state without even a temporary license (and in some of those states, there was an added caveat that the physician could provide only services for free or services related to COVID-19). Other states required a temporary license, which medical personnel could acquire through the states’ health departments.
Most states have ended their emergency declarations and license flexibilities. For providers who made an operational change during the COVID-19 pandemic to bring in out-of-state medical personnel, the end of the PHE could impede their ability to continue to provide services. Providers should evaluate whether their state still has licensure flexibilities in place and if and when those flexibilities will end. Certain states have adopted extensions and/or exceptions, and it may not be too late to take advantage of those.
With the sudden need for telehealth services, some states took advantage of blanket waivers of the Health Insurance Portability and Accountability Act (HIPAA) rules and regulations, where telehealth services otherwise would violate HIPAA. As hospitals scrambled to implement telehealth software, for example, certain entities requested waivers for the use of non-HIPAA-compliant video software to facilitate telemedicine visits, in addition to those described in response to Question 5 on what OCR did.
As these waivers will come to an end in the next few months, providers should consider evaluating the extent to which their organizations made operational decisions based on HIPAA (or other) waivers and the steps they may need to take to become fully HIPAA-compliant, as well as the state-issued waivers, which may require obtaining replacement software or otherwise updating practices.
Question 10 (for DMEPOS providers): Did you take advantage of waivers to the DMEPOS replacement requirements, Medicare Part B and DME signature requirements, or other state-level DMEPOS flexibilities?
CMS permitted a number of different waivers for providers of durable medical equipment prosthetics, orthotics and supplies (DMEPOS), including waivers to the supplier standards and signature requirements. CMS has already resumed or reinstated several of the requirements, including requirements for prior authorization, requirements for accreditation and reaccreditation (including the associated surveys), and requirements to comply with DMEPOS supplier standards. Once the PHE sunsets, the remaining federal-level waivers will end. Likewise, DMEPOS providers should anticipate that any state-level waivers will expire as well.
Specifically, during the PHE, CMS permitted DME MACs to waive certain replacement requirements in connection with DME that is lost, destroyed, irreparably damaged or otherwise rendered unusable. However, once the PHE ends, CMS will reinstate the requirements to have a face-to-face encounter, a new physician’s order and new medical necessity documentation for replacement DME.
During the PHE, CMS also waived requirements related to signatures for certain DME items and services. Currently during the PHE, CMS permits the provision of DMEPOS using verbal orders except for power mobility devices, which require a signed, written order prior to delivery. With the end of the PHE, CMS once again will require the signatures and proofs of DME delivery that it waived when signatures could not be obtained. Similarly, requirements for signed, written orders for the provision of all DMEPOS items will resume.
CMS also will terminate certain payment increases provided for some DMEPOS items and services during the PHE. Under the CARES Act, CMS adjusted fee schedule amounts for various items and services. CMS will continue to adjust fee schedule amounts for certain DMEPOS items and services furnished in nonrural, noncompetitive bidding areas within the contiguous United States, based on a 75/25 blend of adjusted and unadjusted rates until the end of the PHE. Notably, CMS adjusted fee schedule amounts for items and services furnished in rural and noncontiguous, noncompetitive bidding areas across the country based on a 50/50 blend of adjusted and unadjusted rates during the PHE, and CMS subsequently extended those rates after the PHE.
DMEPOS suppliers should be prepared to comply with all pre-2020 requirements related to their provision of DMEPOS to patients and reimplement policies and procedures to ensure the same.
Question 11 (for Medicare Diabetes Prevention Program participants): Did you take advantage of waivers for in-person attendance to first core sessions, limits on virtual services, or once-per-lifetime limits?
CMS permitted certain waivers for Medicare Diabetes Prevention Program (MDPP) suppliers during the PHE that allowed flexibility with respect to virtual services. Once the PHE ends on May 11, 2023, MDPP suppliers once again will be fully subject to the MDPP supplier standards’ in-person requirements. Specifically, an MDPP supplier no longer will be able to provide unlimited virtual makeup sessions, even if the services are performed in a manner consistent with the standards for virtual services. Likewise, participants must attend in person for initial core sessions and weight measurements rather than offering virtual options.
MDPP suppliers should begin to change their scheduling patterns to ensure staffing and protocols work with the end of these waivers. While MDPP suppliers may consider whether any services may still be offered virtually, they should be prepared to transition personnel, equipment and other program processes back to in-person patterns.
Separately, MDPP participants subject to once-per-lifetime limits that received waivers during the PHE likely will be subject to the restrictions once again. Through these waivers, participants receiving services as of Dec. 31, 2020, whose in-person sessions were suspended due to the PHE, had the choice of starting a new set of MDPP services or resuming with the most recent attendance session of record. Similarly, certain participants who began receiving services on or after Jan. 1, 2021 (i.e., in the first 12 months of the set of MDPP services) and had their in-person sessions suspended and who elected not to continue with MDPP services virtually, could elect to start a new set of MDPP services or resume with the most recent attendance session of record. Such flexibilities for participants likely will no longer exist. Suppliers should ensure that their policies and procedures revert to primarily providing services in an in-person format with limits on virtual makeup sessions.
Question 12: Did your hospital receive a 20% increased reimbursement for COVID-19 patients treated during inpatient admissions?
Hospital providers no longer will be eligible for the 20% reimbursement increase for treatment of COVID-19 patients for discharges occurring after the PHE ends. On April 15, 2020, Section 3710 of the CARES Act increased the Inpatient Prospective Payment System COVID-19 diagnosis related group (DRG) reimbursement rates by 20%, for qualifying hospitals. Specifically, the 20% reimbursement increase applied to discharges of an individual diagnosed with COVID-19, as identified by the following ICD-10 diagnosis codes:
- 29, or other coronavirus as the cause of diseases classified elsewhere for discharges occurring on or after Jan. 27, 2020, and on or before March 31, 2020.
- 1 for COVID-19 discharges occurring on or after April 1, 2020, through the duration of the COVID-19 PHE period. Hospital providers do not need to include a modifier on the DRG code to obtain the increased payment.
To remain eligible for the 20% reimbursement increase, for COVID-19 patient admissions occurring on or after Sep. 1, 2020, CMS required hospital providers to include documentation of the patient’s positive COVID-19 viral test in the patient’s medical record. Additionally, the test must have been performed within 14 days of the patient’s admission. Without such documentation, hospital providers face recoupment of the 20% increased reimbursement in the event of a future audit.
Hospital providers may want to include in their internal audits a review of applicable patient medical records for COVID-19 patients to ensure the appropriate laboratory testing records were included by the time of the patient’s discharge for those that had such ICD-10 diagnosis codes included in their medical bill. Further, hospitals may want to ensure that their financial budgets and plans are considering these reduced reimbursement rates after May 11, 2023.
The flexibilities granted by the federal government during the PHE were widespread. As the PHE winds down, with its termination on May 11, 2023, providers must take the appropriate steps to ensure compliance as pandemic-era flexibilities and programs expire. Failure to do so will create serious legal and financial risks.
Please contact the authors for additional guidance on how to navigate the end of the PHE. Note that while this article addresses many of the most pressing questions related to the expiration of the PHE, it is not exhaustive of all federal policies and waivers implemented during the PHE. The Centers for Medicare & Medicaid Services provides a more detailed list of the waivers implemented throughout the PHE.
McGuireWoods has published additional thought leadership analyzing how companies across industries can address crucial business and legal issues related to COVID-19.