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Telehealth and the End of the COVID-19 Emergency

by Jacob Mattinson, Sarah Raaii, Alden Bianchi and Teal Trujillo | Mar 22, 2023 | Employee Benefits, Health and Welfare Plans

The Biden administration has announced its intent to end the COVID-19 National Emergency (NE) and the COVID-19 Public Health Emergency (PHE) on May 11, 2023 (read our prior article for more information). In response to the COVID-19 pandemic, lawmakers and agencies made legislative and regulatory changes to expand access to telehealth services for individuals. This article explores what will happen to these temporary telehealth benefits at the end of the PHE and NE.

Current flexibilities under the Affordable Care Act (ACA) allow applicable large employers (ALEs) to offer stand-alone telehealth and remote care services to employees who were not eligible for other employer coverage during the PHE.

In addition, the Coronavirus Aid, Relief, and Economic Security Act (CARES) Act and IRS Notice 2020-29 established a temporary telehealth safe harbor, providing that a high-deductible health plan (HDHP) could cover telehealth and other remote care services on a pre-deductible basis without impacting an individual’s ability to contribute to an HSA. This relief applied to services provided on or after January 1, 2020, with respect to plan years beginning on or before December 31, 2021. Thus, for most calendar-year plans, this relief ended on December 31, 2021. The Consolidated Appropriations Act, 2022 (CAA 2022) renewed the relief under the CARES Act for months beginning after March 31, 2022, and before January 1, 2023—but it created a three-month gap in coverage from January 1, 2022, to March 31, 2022. The CAA 2022 also extended certain flexibilities related to Medicare coverage and payment for telehealth services through the end of 2024. The relief provided under the CAA 2022, however, was provided on a temporary basis and not tied to the PHE or NE.

Effective December 29, 2022, the Consolidated Appropriations Act, 2023 (CAA 2023) provided a two-year extension allowing first-dollar coverage of telehealth under an HDHP so that individuals can access services without needing to meet a deductible first. The CAA 2023 extends telehealth relief for plan years beginning after December 31, 2022, and before January 1, 2025. Most calendar year plans should therefore have coverage of pre-deductible telehealth services without affecting HSA eligibility for all of 2023 and 2024. When the PHE ends, stand-alone telehealth offerings must cease, but telehealth offerings on a pre-deductible basis can continue.

The stand-alone telehealth relief under the ACA is available until the end of the latest plan year that begins on or before the last day of the PHE. For calendar-year plans, this relief would last until December 31, 2023. When an employer ends its stand-alone telehealth benefit, it may need to provide participants a 60-day notice of a material reduction in benefits.

Employers offering telehealth coverage on a pre-deductible basis with HDHPs have been provided statutory relief through December 31, 2024, through the CAA 2023. However, employers should continue to watch for legislative updates regarding telehealth. Lawmakers have proposed multiple other bills in Congress to extend or make permanent telehealth flexibilities.

For any [...]

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GOP Calls Biden’s Medicare Plans a Tax Hike on Small Businesses

by McDermott Will & Emery | Mar 17, 2023 | Health and Welfare Plans

Republican lawmakers are calling the Biden administration’s plan to extend the Medicare trust fund’s solvency a tax hike on small businesses. According to this InsideHealthPolicy article, US House Committee on Ways and Means Republicans say their own legislation would protect Medicare benefits if the country runs against its spending limit.

Coverage of COVID-19 Testing and the End of the COVID-19 Emergency

by Jacob Mattinson, Sarah Raaii, Alden Bianchi and Teal Trujillo | Mar 8, 2023 | Employee Benefits, Health and Welfare Plans

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

by Jacob Mattinson, Sarah Raaii, Alden Bianchi and Teal Trujillo | Mar 2, 2023 | Employee Benefits, Health and Welfare Plans

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.

Prescription Drug Data Reporting: What the “Good Faith Compliance” Extension Really Means for Self-Funded Group Health Plans

by Jacob Mattinson, Sarah Raaii and Alden Bianchi | Jan 11, 2023 | Employee Benefits, Executive Compensation, Health and Welfare Plans, Retirement Plans

We recently reported on an FAQ issued December 23, 2022 (FAQ About Affordable Care Act and Consolidated Appropriations Act, 2021 Implementation Part 56) by the US Departments of Labor, Health and Human Services and the Treasury (collectively, the Departments). The FAQ provides limited, albeit welcome, relief by extending the time for reporting information under the prescription drug data collection (RxDC) rules, which were enacted by Section 204 of Title II of Division BB of the Consolidated Appropriations Act, 2021.

Under the statute, the first RxDC reports for the 2020 calendar (or reference) year, were due to be filed by December 27, 2021. However, in response to concerns expressed by stakeholders, enforcement was pushed back a full year to December 27, 2022, at which time the reports for both the 2020 and 2021 reference years were due. The RxDC reporting process required the submission of one or more “plan lists,” a series of eight data files (files D1 through D8) and an accompanying narrative response. (The contents of the plan lists, data files and narrative responses are comprehensively explained here (the Instructions).)

Access the full article.

An Overhaul for Medicare’s Pay Transformation Program

by Mara McDermott | Dec 6, 2022 | Employee Benefits, Health and Welfare Plans

The Biden administration recently finalized an overhaul of an initiative known as the Medicare Shared Savings Program that seeks to pay health providers based on patient outcomes instead of the number of services they perform. In this Axios article, McDermott+Consulting’s Mara McDermott offers insight into providers’ Congressional push to extend a 5% pay increase for participants in advanced alternative payment models.

“If the bonus is not continued, it will soften or dampen the momentum toward alternative payment models, because it would create this mentality, or the view, that we’re not serious about that transformation,” McDermott said.

Access the article.

Medicare Drug Price Negotiation Program and Drug Pricing Reform: Eligible Drugs to Know and Understanding What’s Next

by McDermott Will & Emery | Nov 1, 2022 | Benefit Controversies, Employee Benefits, Health and Welfare Plans

On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (IRA), which contains prescription drug pricing reform provisions. The three main Medicare prescription drug pricing reform provisions included are as follows:

Drug Price Negotiations: Allows the federal government to negotiate for a select number of vaccines and/or drugs
Inflation-Based Rebates: Mandates that manufacturers pay a rebate to the federal government when the list prices of Part B or Part D drugs grow at a faster rate than the inflation rate
Part D Benefit Redesign: Implements an out-of-pocket maximum for beneficiaries at $2,000 and redistributes liability among manufacturers, health plans, patients and the federal government across phases of the Part D benefit starting in 2024.

Leveraging data from the Centers for Medicare and Medicaid Services’ (CMS’s) Medicare Drug Spending Dashboard and FDA databases, McDermott+Consulting has identified the potential list of drugs subject to negotiations.

This information is particularly valuable for pharmaceutical companies, health plans, patients, pharmacies and other stakeholders as they evaluate and consider the implications of this legislation. In less than one year, on September 1, 2023, the Health and Humans Services (HHS) Secretary will publish the first list of selected drugs subject to drug price negotiations. Understanding the statutorily mandated negotiations framework, timeline and potential drugs that may be included is critical to support stakeholders’ efforts to obtain optimal outcomes.

This report describes the drug price negotiation program, an implementation timeline for drug price reforms from the IRA and information on which drugs are likely to be first subject to price negotiation.

Download the report.

GAO Releases Report on Telehealth

by McDermott Will & Emery | Oct 25, 2022 | Digital Health, Employee Benefits, Health and Welfare Plans

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.

The Inflation Reduction Act of 2022: Healthcare Provisions

by McDermott Will & Emery | Sep 9, 2022 | Benefit Controversies, Digital Health, Employee Benefits, Health and Welfare Plans

After almost a year of negotiations among congressional Democrats and the White House, the Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022. It passed in the US Senate by a vote of 50–50, with the vice president breaking the tie, on August 7, 2022. The bill passed the US House of Representatives August 12, 2022, by a party-line vote of 220-207. This McDermott+Consulting article summarizes the key healthcare provisions of the IRA, including prescription drug reform, inflationary rebates, a cap on insulin costs, a Medicare Part D benefit redesign and a new pharmacy benefit manager rebate rule.

US House Passes Telehealth Extension Through 2024

by McDermott Will & Emery | Aug 8, 2022 | Digital Health, Employee Benefits, Health and Welfare Plans

The US House of Representatives approved a bipartisan bill that would extend Medicare telehealth flexibilities through the end of 2024; immediate US Senate action on the bill is unlikely, however.

On July 27, 2022, the US House of Representatives approved the Advancing Telehealth Beyond COVID-19 Act (H.R. 4040) by a wide bipartisan margin of 416–12. This bill would extend Medicare telehealth flexibilities through the end of 2024, including geographic and originating site flexibilities, expanded eligible practitioners, reimbursement for federally qualified health centers and rural health clinics, delay of the in-person telemental health requirement, continued use of audio-only telehealth and flexibility to use telehealth to satisfy Medicare face-to-face requirements.

Immediate US Senate action on H.R. 4040 is not likely, as the Senate is working on other priorities heading into the August recess. In addition, given the limited number of legislative days on the calendar before the midterm elections, additional action on telehealth extensions is more likely to occur during Congress’s lame-duck session at the end of the year. These same provisions were extended for 151 days beyond the end of the public health emergency (PHE) through the enactment of the Consolidated Appropriations Act of 2022, making it less urgent for Congress to act on an extension before the end of the year—although this bill has significantly increased chances of Congress doing so.

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