SubscribeCEOs may think they are fully in control of their workforces, but this belief may be more of an illusion than reality. In this Forbes article, McDermott Partner Michael Peregrine says certain pandemic-era changes to their authority may be more lasting than they realize–especially as it relates to their dynamic with the board of directors.
COVID-19
Coverage of COVID-19 Vaccines and the End of the COVID-19 Emergency
Since the Biden administration announced its intention to end the COVID-19 National Emergency (NE) and the COVID-19 Public Health Emergency (PHE) on May 11, 2023, a topic of great debate has been the requirement and the coverage of COVID-19 vaccines.
As of March 27, 2020, the Coronavirus Aid, Relief, and Economic Security (CARES) Act has required health plans and issuers to cover COVID-19 vaccines without cost sharing, even when provided by out-of-network providers, during the PHE. Health plans and issuers have been required to cover COVID-19 vaccines within 15 days after any vaccine becomes recommended by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention or receives a rating of “A” or “B” classification recommendation from the United States Preventive Services Task Force (USPSTF). Separately, the Affordable Care Act (ACA) generally requires coverage of vaccines recommended by the ACIP and the USPSTF as preventative care without cost sharing. If a COVID-19 vaccine is provided by an out-of-network provider, however, health plans may begin to impose cost sharing and certain prior authorization and medical management requirements. As a result, after the PHE, COVID-19 vaccines will still need to be covered without cost sharing except in the case of an out-of-network provider.
Due to the ongoing requirements of the ACA, there will be minimal actions that employers need to take after the PHE ends regarding vaccine coverage. The primary changes are that ACIP-recommended COVID-19 vaccines should be covered immediately instead of after a 15-day hold period and that health plans can decide whether to apply cost sharing, prior authorization and medical management requirements to COVID-19 vaccines obtained from an out-of-network provider. A summary of material modifications and/or plan amendment may be required for any changes the health plan makes. Even for plans that are not subject to the ACA, such as grandfathered health plans, participants cannot be balance billed if a vaccine dose was purchased by the federal government. However, the federal government has not received additional funds from Congress to continue to purchase more vaccines for some time. Employers and plan sponsors should stay up to date on developments, as there may be some questions regarding which vaccines must be covered without cost sharing as more vaccines become available.
For any questions regarding the end of the PHE and/or NE, please contact your regular McDermott lawyer or one of the authors.
Coverage of COVID-19 Testing and the End of the COVID-19 Emergency
A key feature of the COVID-19 National Emergency (NE) and the COVID-19 Public Health Emergency (PHE) was the government’s ability to provide access and coverage of COVID-19 tests. This resulted in overlapping legislation targeted at providing tests to benefit plan participants for free.
With the end of the NE and PHE set for May 11, 2023, there is confusion about what will happen to COVID-19 testing.
Starting on March 18, 2020, the Families First Coronavirus Response Act (FFCRA) required all public and private insurance coverage, including self-funded plans, to cover COVID-19 tests and costs associated with diagnostic testing with no cost-sharing for the duration of the PHE. The Coronavirus Aid, Relief, and Economic Security (CARES) Act enacted shortly after expanded this requirement to cover out-of-network tests during the PHE. The Consolidated Appropriations Act of 2021 (CAA) then took a new approach and applied the requirement to over-the-counter (OTC) COVID-19 tests and added additional obligations. Under guidance issued by the US Departments of Labor, Health and Human Services, and Treasury, effective January 15, 2022, health plans were required to cover up to eight free OTC at-home tests per covered individual per month. Health plans could limit the reimbursement of these tests to the lesser of the actual or negotiated price or $12 per test. Health plans could also provide tests through participating network providers, such as pharmacies or retailers.
When the PHE ends, health plans will no longer be required to cover COVID-19 tests, either diagnostic or OTC, or testing-related services with no cost-sharing.
Employers should consider whether they want to continue to cover COVID-19 tests as required by a doctor or OTC without cost sharing. There is no requirement to stop doing this after the PHE but doing so may have some implications on group health plans. Importantly, if an employer decides to continue covering testing at no cost, they should consider how this affects any employer-sponsored high-deductible health plan (HDHP). IRS Notice 2020-15 permitted HDHP coverage of COVID-19 testing with no cost-sharing without conflicting with HSA eligibility (see our article here). This relief continues until further guidance is issued. Though COVID-19 testing could be considered preventative care under Section 223 of the Internal Revenue Code, the US Department of Treasury will need to provide further clarification. Employers should also consider whether they want to continue to apply a $12 reimbursement cap on COVID-19 or some other limitation.
After the PHE, employers who choose to continue to cover COVID-19 tests at no cost or apply a reimbursement cap may need to amend their plans or summary plan descriptions for these practices. They will also need to coordinate with any insurer or third-party administrator of the employer’s group health plan to ensure proper administration. Depending on the timing of these amendments, they may also need to provide a summary of material modifications to participants. Employers who decide not to continue coverage of COVID-19 tests or apply a reimbursement cap may need to amend their plans, depending on whether [...]
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How Employers Need to Prepare for the End of the COVID Public Health Emergency and National Emergency
On January 30, 2023, the Biden administration announced its intention to make final extensions of both the COVID-19 National Emergency (NE) and the COVID-19 Public Health Emergency (PHE) through May 11, 2023, at which point both will end. These emergency declarations have been in place for nearly three years and have enabled the government to modify certain coverage requirements by Medicare, Medicaid and private insurance plans, as well as benefits administration rules. The end of the PHE and NE may mean added costs for benefits plans and new questions regarding compliance. This series will explore the implications of the PHE and NE and what their impending end may mean for benefit plan sponsors with articles released periodically before May 11.
There are several important benefit coverage and administration requirements connected to the PHE and/or NE that may remain the same, remain for a temporary period or may need to be discontinued upon the end of these federal emergencies. Over the course of the upcoming weeks, we will cover the key topics that may be triggered by the end of the PHE and/or NE, including:
- COVID-19 Testing (Part 2 of 10)
- COVID-19 Vaccines (Part 3 of 10)
- Telehealth (Part 4 of 10)
- Mental Health Parity (Part 5 of 10)
- High Deductible Health Plans, Health Savings Accounts and Employee Assistance Plans (Part 6 of 10)
- Deadline Tolling Applied to Each of:
- COBRA (Part 7 of 10)
- Claims and Appeals + External Review (Part 8 of 10)
- HIPAA Special Enrollment (Part 9 of 10)
- Other Plan-Related Notices (Part 10 of 10)
Note that the items covered above are not an exhaustive list of all legislative and regulatory changes that could affect employee benefit plans. This series is meant to keep employers informed about some of the most important upcoming changes and the impending decisions and disclosures that need to be made.
For any questions regarding the end of the PHE and/or NE, please contact your regular McDermott lawyer or one of the authors.
Amid Dwindling COVID Relief Funds, Rural Hospitals Face a ‘Fiscal Cliff’
What do healthcare leaders predict is next for rural hospitals? In this Fierce Healthcare article, McDermott Partner Emily Jane Cook offers her perspective about rural emergency hospitals and possible legislative action around them.
Pandemic Response Accountability Committee Report Highlights Telehealth Program Integrity Concerns
On December 1, 2022, the Pandemic Response Accountability Committee (PRAC) Health Care Subgroup issued its report on fraud, waste and abuse risks that arose as a result of the dramatic increase in telehealth services provided during the COVID-19 pandemic. The PRAC was created under the CARES Act to oversee the historic spending that was part of the federal government’s response to the COVID-19 pandemic. The PRAC Health Care Subgroup comprises the offices of the inspector general (OIGs) for six federal agencies:
- The US Department of Health and Human Services (HHS)
- The US Department of Defense (DoD)
- The Office of Personnel Management (OPM)
- The US Department of Veterans Affairs (VA)
- The US Department of Labor (DOL)
- The US Department of Justice (DOJ).
Each OIG oversees an agency that administers a federal program connected to using or paying for telehealth services.
The report highlights the increased access to services that telehealth facilitated during the pandemic and notes key focus areas with respect to program integrity and preventing fraud and abuse. The report is a resource intended to be used by stakeholders across the healthcare industry, including congressional lawmakers, federal and state agencies, and healthcare organizations. The report aims to raise awareness of the importance of safeguarding expanded telehealth services against fraud, waste and abuse.
Senate Approves Resolution to End COVID-19 National Emergency Declaration
On November 15, the Senate approved a resolution to end the national emergency concerning COVID-19 declared by the president on March 13, 2020. The resolution was approved by a bipartisan vote of 62–36, with 13 Democrats joining all present Republicans in voting for the resolution.
While ending the national emergency is different than ending the public health emergency (PHE), which is declared by the US Department of Health and Human Services (HHS), the two are related, as the PHE must be tied to another declaration. Should the national emergency declaration end (as intended in this Senate resolution), most current waivers would terminate. There are notable exceptions, however, where other pieces of legislation have enacted additional flexibility (including telehealth waivers), and where policy changes in HHS rulemakings specified that policy changes are tied to the PHE. Should the national declaration end but the PHE stand, such policies would continue until the end of the PHE. Should both the national emergency declaration and the PHE end, all waiver authority would cease. Please see this +Insight for additional information.
The COVID-19 PHE, which is extended in 90-day increments, was most recently extended in mid-October, until mid-January 2023. The Biden administration has maintained a commitment to provide 60 days’ advance notice of any plans to end the PHE, and that 60-day mark recently passed with no indication that the PHE will end in mid-January. This indicates that the PHE is likely to be extended at least once more, through mid-April 2023.
Senate passage of this resolution will not have a tangible impact, as it is unlikely to be taken up by the Democratic-controlled House this year, and the president has threatened to veto it. However, the vote in the Senate demonstrates “pandemic fatigue” as well as significant bipartisan support for ending COVID-19 declarations, which suggests that the next presumed PHE extension through mid-April 2023 could be the last.
CMS Downshifts on Expectations for Covered Healthcare Provider Staff COVID-19 Vaccination
The Centers for Medicare & Medicaid Services (CMS) released guidance for surveyors that provides leeway in surveying for compliance with the November 2021 interim final rule with comment that imposed a vaccination mandate for most staff at certain covered provider types.
COVID and a Cloud of Dust
The COVID-19 pandemic forced lawmakers to respond with an array of legislation to help Americans, such as the No Surprises Act, the Families First Coronavirus Responses Act and the Coronavirus Aid, Relief and Economic Security Act. Now, however, pandemic-related litigation involving the Employee Retirement Income Security Act of 1974 (ERISA) is becoming more common. In this Best Lawyers article, McDermott Partner Ted Becker highlights the major types of pandemic-related litigation, including out-of-network provider litigation, the Racketeer Influenced and Corrupt Organizations Act (RICO) and antitrust claims, and COVID-19-related litigation against ERISA health plans.
GAO Releases Report on Telehealth
On September 26, the US Government Accountability Office (GAO) released a report titled “Medicare Telehealth: Actions Needed to Strengthen Oversight and Help Providers Educate Patients on Privacy and Security Risks.” The 75-page report describes the utilization of Medicare telehealth services under current pandemic-related waivers, the Centers for Medicare & Medicaid Services (CMS) efforts to identify and monitor risks posed by the current waivers, and a change made by the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) to the enforcement of regulations governing patients’ protected health information during the COVID-19 public health emergency (PHE).
GAO made four recommendations—three directed to CMS and one directed to OCR—aimed at remedying the issues set forth in the report:
- CMS should develop an additional billing modifier or clarify its guidance regarding billing of audio-only office visits to allow the agency to fully track these visits.
- CMS should require providers to use available site of service codes to indicate when Medicare telehealth services are delivered to beneficiaries in their homes.
- CMS should comprehensively assess the quality of Medicare services, including audio-only services, delivered using telehealth during the PHE.
- OCR should provide additional education, outreach or other assistance to providers to help them explain the privacy and security risks to patients in plain language when using video telehealth platforms to provide telehealth services.
Among its utilization findings, the GAO report found that the use of telehealth services increased from about five million services pre-waiver (April to December 2019) to more than 53 million services post-waiver (April to December 2020) and that, post-waiver, 5% of providers delivered more than 40% of telehealth services, and 5% of beneficiaries accounted for almost 40% of telehealth utilization.
The report noted that CMS lacks complete data on the use of audio-only technology and telehealth visits furnished in patients’ homes, because there is no billing mechanism for providers to identify all instances of audio-only visits, and because providers are not required to use available codes to identify visits furnished in homes. The GAO report also noted that OCR did not advise providers about specific language to use or give direction on explaining risks to patients, with respect to OCR’s March 2020 policy that it would not impose penalties against providers for noncompliance with privacy and security requirements in connection with the good faith provision of telehealth during the PHE.
This GAO report comes on the heels of a recent report from the HHS Office of Inspector General that found little evidence of waste and fraud related to Medicare telehealth services during the first year of the pandemic. These reports are part of a broader push by Congress and the Biden administration to examine current telehealth flexibilities and determine how to extend them beyond the COVID-19 PHE.
