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Telehealth Trends to Watch: Increased Focus on Privacy and Security

We expect to see continued focus on privacy and security at the federal and state level. For example, California, Virginia, Colorado, Utah and Connecticut have new privacy laws coming into effect in 2023. As part of our State Law Privacy Video Series, McDermott described how these laws will affect health data and healthcare entities—in particular, those entities that are regulated by HIPAA.

In addition, at the end of 2022, the US Department of Health and Human Services (HHS) proposed long-awaited changes to the regulations protecting the confidentiality of substance-use disorder patient records under Part 2 of Title 42 of the Code of Federal Regulations (42 CFR Part 2, or Part 2). Specifically, the proposed rule would implement provisions of Section 3221 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which required HHS to align Part 2 with certain provisions of HIPAA and to make certain changes to the HIPAA Notice of Privacy Practices, the form given to patients and plan members that describes patient privacy rights, covered entity duties, and the covered entity’s uses and disclosures of protected health information.

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Telehealth and the End of the COVID-19 Emergency

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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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.




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Major Changes Proposed to Substance Use Disorder Confidentiality Law

In a Notice of Proposed Rulemaking published December 2, 2022 (the Proposed Rule), the United States Department of Health and Human Services (HHS) proposed long-awaited changes to the regulations protecting the confidentiality of substance use disorder patient records under Part 2 of Title 42 of the Code of Federal Regulations (42 CFR Part 2, or Part 2). Specifically, the Proposed Rule would implement provisions of Section 3221 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which required HHS to align Part 2 with certain provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and to make certain changes to the HIPAA Notice of Privacy Practices, the form given to patients and plan members that describes patient privacy rights, covered entity duties, and the covered entity’s uses and disclosures of protected health information (PHI).

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Save It for a Rainy Day: Recent Amendment Extensions for Qualified Retirement Plans, 403(b) Plans and Individual Retirement Accounts

The Internal Revenue Service (IRS) recently issued needed relief to extend some amendment deadlines for non-governmental qualified retirement plans and 403(b) plans, and for individual retirement accounts (IRAs) under the Setting Every Community Up for Retirement Enhancement Act of 2019 (SECURE Act), the Bipartisan American Miners Act of 2019 (Miners Act), and certain provisions of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) until December 31, 2025. However, the IRS did not provide relief for all required amendments for the 2022 plan year. Plan sponsors that elected to offer COVID-related distributions or loan relief (or utilized disaster-related relief for loans or distributions under the Taxpayer Certainty and Disaster Tax Relief Act of 2020) still need to amend their plans by the end of 2022 plan year.

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Are Out-of-Pocket Costs on Their Way Out? At-Home COVID-19 Testing and Expanded Preventative Healthcare for Women and Children

In response to a directive from the White House, based on provisions of the Families First Coronavirus Response Act (FFCRA) and the Coronavirus Aid, Relief and Economic Security (CARES) Act that eliminated cost sharing for COVID-19 diagnostic testing, three federal government departments—the US Department of Health and Human Services (HHS), the US Department of Labor (Labor) and the US Department of the Treasury (Treasury)—issued guidance in the form of frequently asked questions (FAQs) that states group health plans and insurers must also cover over-the-counter (OTC) COVID-19 diagnostic testing. This guidance is effective beginning January 15, 2022.

In addition, the Health Resources and Services Administration (HRSA) updated the Affordable Care Act’s (ACA) comprehensive preventive care and screening guidelines for women and children to cover additional services and supplies without a copay or deductible, effective 2023.

COVID-19 AT-HOME TESTING COVERAGE

On January 10, 2022, HHS, Labor and the Treasury together issued FAQs that elaborated on prior guidance and indicated that group health plans and insurers are required to cover OTC COVID-19 diagnostic tests without cost sharing. Because of the recent spike in COVID-19 cases resulting from the rapid spread of the Omicron variant, the guidance will continue for the duration of the public emergency.

Most consumers with private health coverage will be able to buy OTC COVID-19 tests and either have the cost covered upfront or be reimbursed later by submitting a claim to their health plan. The new requirement only applies to “diagnostic” OTC COVID-19 testing. It does not include the treatment of COVID-19 or testing that is for employment purposes.

The guidance provides that health plans and insurers must cover at least eight OTC COVID-19 diagnostic tests per covered individual per a 30-day period. Insurers will be able to set up networks of preferred suppliers to provide OTC COVID-19 tests directly to participants without upfront costs. Insurers must still reimburse OTC COVID-19 tests purchased outside the direct coverage program, however, the reimbursable amount is limited to $12 per test if the health plan also provides tests through its preferred pharmacy network and through a direct-to-consumer shipping program without upfront costs.

Besides the risk of increasing the average cost of OTC COVID-19 tests, the new initiative raises concerns over fraud and abuse. For health plans and insurers to protect themselves, the FAQs provide several examples of permissible activities to prevent fraud and abuse, like requiring proof of purchase or an attestation that the test was purchased for proper purposes (i.e., is being used by the covered individual, is not being reimbursed by another source, is not being resold and is not for employment purposes).

HRSA UPDATES ACA PREVENTIVE HEALTHCARE GUIDELINES

On January 11, 2022, HRSA announced that it updated the preventive health and screening guidelines for women, infants, children and adolescents. Under the ACA, certain group health plans and insurers must provide coverage with no out-of-pocket costs for preventive health services within these HRSA-endorsed comprehensive guidelines.

HRSA accepted the updates recommended by the Women’s Preventative [...]

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Global Employment Law Update

Employment law continues to evolve, and it can be a challenge amid an ever-changing landscape of local employment laws for human resources executives and employment counsel at multinational businesses to maintain a consistent global corporate culture.

McDermott’s Global Employment Law Update brings you the key highlights from across Asia, Africa, Europe, Latin and North America. Developed in collaboration with peer firms operating in more than 50 countries, this resource guide contains summaries of the laws and significant court decisions that impacted employers and employees all over the world. It includes:

  • COVID-19 legislative updates
  • Remote work and telecommuting policies
  • Data privacy protections
  • Minimum wage and salary compensation updates
  • Changes to labor protection laws
  • Sexual harassment modifications

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Recent Developments in Employer Student Loan Repayment Benefits

Last month, McDermott partner Jeffrey M. Holdvogt was a speaker at the ERIC March Financial Wellness Huddle on the topic of Recent Developments in Employer Student Loan Repayment Benefits. His presentation covered:

  • Student loan repayment benefits
  • Employer options for student loan benefits
  • CARES Act Educational Assistance Program
  • Converting unused PTO funds to student loan debt relief
  • Retirement plan options

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IRS Provides Additional COVID-19 Relief for Cafeteria Plans

On February 18, 2021, the Internal Revenue Service (IRS) issued clarifying guidance on the temporary special rules for health flexible spending arrangements (FSAs) and dependent care assistance programs (DCAPs). This provides welcome guidance regarding the application of cafeteria plan relief provided by the Consolidated Appropriations Act (CAA).

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