Health and Welfare Plans Archives - Page 18 of 129

Tri-Agencies Address Preventive Services Coverage in the Wake of Braidwood

by Sarah Raaii, Jacob Mattinson, Alden Bianchi and Teal Trujillo | May 5, 2023 | Employee Benefits, Health and Welfare Plans

The US Departments of Labor, Health and Human Services, and the Treasury (the Departments) have released a series of Frequently Asked Questions (FAQs) in response to Braidwood Mgmt. Inc. v. Becerra, a recent case that invalidated a portion of the Affordable Care Act (ACA) preventive services mandate. The FAQs aim to address inquiries from stakeholders, while also emphasizing the Departments’ opposition to the Braidwood ruling. The Departments urge plans and issuers to continue providing coverage for preventive services at no additional cost to patients.

Read more here.

Healthcare Preview for the Week of May 1, 2023

by Debra Curtis, Katie Waldo, Kayla Holgash and Rodney Whitlock | May 4, 2023 | Digital Health, Employee Benefits, Health and Welfare Plans

There has been a flurry of activity in Congress focused on healthcare issues over the last two weeks. Committees in both the US House and Senate held hearings on legislation focused on increasing transparency and competition in the healthcare system that could have significant impacts for certain healthcare providers, healthcare plans and pharmacy benefit managers.

Read more here.

Preparing for the End of the COVID-19 Emergency: High-Deductible Health Plans and Health Savings Accounts

by Jacob Mattinson, Sarah Raaii, Alden Bianchi and Teal Trujillo | May 3, 2023 | Employee Benefits, Health and Welfare Plans

The Biden administration originally 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). Although the end date of the NE was subsequently advanced to April 10, 2023, by Congressional resolution, the US Departments of Labor, Health and Human Services, and the Treasury (the Departments) have given no indication that the change will affect employee benefits plans. Plan sponsors should continue to treat May 11 as the end of the NE until the Departments say otherwise.

During the COVID-19 pandemic, certain permissive practices were allowed by high-deductible health plans (HDHPs) and health savings accounts (HSAs). This article explores whether these benefit offerings can be continued at the end of the PHE and NE.

HDHPs AND HSAs

IRS Notice 2020-15 temporarily permits the coverage of COVID-19 testing with no cost-sharing for HDHPs. It provides that an HDHP will not fail to be an HDHP merely because the plan covers expenses related to COVID-19 testing and treatment prior to satisfying the applicable minimum deductible. This guidance was not directly tied to the NE or the PHE, meaning that it will eventually lapse. The eighth question/answer of the FAQs indicates that individuals covered by an HDHP who have purchased items related to COVID-19 testing or treatment prior to meeting the applicable minimum deductible can continue to contribute to an HSA until further guidance is issued. The Departments also assured plan sponsors that future changes will generally not require HDHPs to make mid-year changes for covered individuals to remain eligible to contribute to an HSA.

Thus, individuals covered by an HDHP may continue to contribute to an HSA following the end of the PHE. COVID-19 vaccinations also continue to be considered preventive care under Section 223 of the Code for purposes of determining whether a health plan is an HDHP.

ACTION ITEMS

Once the PHE and NE have ended, employers can continue their practice of allowing individuals covered by an HDHP plan to contribute to an HSA. Employers need to also consider whether they will continue to cover COVID-19 tests as required by a doctor or OTC without cost-sharing. Employers should strategize what effect this might have on the HDHP. This might also require an amendment to the health plan or its summary plan description. Employers should continue to watch for further guidance from the Departments on this issue.

Washington State Legislature Passes My Health My Data Act

by David Saunders, Alya Sulaiman, Sam Siegfried and Austin Mooney | May 2, 2023 | Digital Health, Employee Benefits, Health and Welfare Plans

The My Health My Data Act in Washington State (the Act) is expected to be signed into law by Governor Jay Inslee this year, after being passed by both the Washington Senate and House in different versions. Unlike recent state privacy laws, the Act specifically targets consumer health data that is not covered by the Health Insurance Portability and Accountability Act (HIPAA). It includes provisions that apply to processors and third parties who may handle a broadly defined set of consumer health data, beyond healthcare-adjacent businesses. The Act could have a significant impact on various entities, including advertisers, mobile app providers, wearable device manufacturers, healthcare companies and their data processors who handle non-HIPAA-regulated health information.

Read more here.

Health Data in the EU and UK: Regulatory Trends and Developments

by Sharon Lamb, Deniz Tschammler, Daniel F. Gottlieb, Lorraine Maisnier-Boché and Pilar Arzuaga | Apr 25, 2023 | Digital Health, Employee Benefits, Health and Welfare Plans

With the General Data Protection Regulation (GDPR) resulting in a rise in enforcement incidents, it is prudent for organizations operating in the health and life sciences industries across the United Kingdom, European Union (EU) and other European Economic Area (EEA) nations to assess their responsibilities regarding the gathering and handling of health data.

Major Points:

“Data concerning health” is a wide term; it doesn’t just apply to medical records. Policies and processing records should accurately capture all health data, including inference data.
Most EEA countries, and the United Kingdom, have national laws that supplement GDPR.
Consent is not the only legal basis for collecting, storing and using health data; there are other options available, but be aware that “insufficient legal basis for data processing” is a common type of GDPR violation.
If used, health data consents must be granular, specific and transparent, and they must break down all the purposes for which the data is being processed. Consent must be granted on an “opt-in” basis and not as a result of a pre-filled tick box.
Health data may be reused for genuine scientific research purposes provided the processing is compatible with the original use, appropriate safeguards are in place and any separate national law conditions are satisfied.
Privacy policies and transparency notices must be clear about the basis on which health data is processed.
Proceed carefully and consider reidentification risk when relying on anonymisation to process data; document any reidentification risk assessment and periodically review risk assessment in light of developments in publicly available data and evolving risk environment. Technical measures, such as evolving encryption standards, should be reviewed periodically.

Read more here.

OCR Issues Proposed Rule to Modify HIPAA Privacy Rule to Include Explicit Protections for Reproductive Healthcare

by Stacey Callaghan, Jiayan Chen, Caroline Reignley, Scott Weinstein and Dexter Golinghorst | Apr 20, 2023 | Digital Health, Employee Benefits, Health and Welfare Plans

On April 12, 2023, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a notice of proposed rulemaking detailing its proposal to modify the HIPAA Privacy Rule (Proposed Rule). The Proposed Rule comes as a part of the Biden administration’s response to the US Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization.

The Proposed Rule would provide special protections for protected health information (PHI) related to reproductive healthcare. Following the Dobbs decision, many healthcare providers expressed concerns that PHI related to reproductive healthcare may be sought by state and local governments for use in criminal, civil or administrative investigations or proceedings. OCR noted that such compelled uses and disclosures of PHI could have a chilling effect on lawfully obtained healthcare and erode trust in confidential communications between a patient and provider. Additionally, providers could elect to leave out critical details from a patient’s medical record if they fear the information could later be used by a state or local government actor against the patient.

Stakeholders may submit comments on the proposed rule on or before June 16, 2023.

Read more here.

Telehealth Trends to Watch: Increased Focus on Privacy and Security

by Lisa Schmitz Mazur, Dale C. Van Demark, Amanda Enyeart and Marshall E. Jackson, Jr. | Apr 19, 2023 | Digital Health, Employee Benefits, Health and Welfare Plans

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.

Read more here.

ERISA Preemption Developments in Managed Care

by Jeremy Earl and Kate McDonald | Apr 13, 2023 | Employee Benefits, Health and Welfare Plans

For plans governed by the Employee Retirement Income Security Act of 1974, 29 U.S.C. §§ 1001-1461 (ERISA), the doctrine of federal ERISA preemption over state statutes, regulations or administrative schemes has been a central subject of litigation since the inception of the statute. In December 2020, the US Supreme Court issued a decision on the subject in Rutledge v. Pharm. Care Mgmt. Ass’n, 208 L. Ed. 2d 327 (2020).

In the short, unanimous opinion, the Supreme Court in Rutledge held that ERISA did not preempt an Arkansas statute that regulates pharmacy benefit managers’ (PBM) drug reimbursement rates. Arkansas passed Act 900 in 2015 to regulate PBM reimbursement rates for pharmacies, which, in effect, established a reimbursement floor that requires PBMs to reimburse pharmacies at a rate that reflects the pharmacy’s acquisition cost for the drug in question.

Access this McDermott Health 2023 Annual Report (pg. 9).

Preparing for the End of the COVID-19 Emergency: Tri-Agencies Issue FAQs to Assist Plans and Issuers

by Jacob Mattinson, Sarah Raaii, Alden Bianchi and Teal Trujillo | Apr 5, 2023 | Employee Benefits, Health and Welfare Plans

The Biden administration has announced its intention to end the COVID-19 National Emergency (NE) and the COVID-19 Public Health Emergency (PHE) on May 11, 2023 (read our series introduction for more information).

On March 29, 2023, the US Departments of Labor, Health and Human Services, and Treasury (the Departments) issued a set of Frequently Asked Questions (available here), which answered questions from stakeholders relating to the various laws, regulations and other guidance enacted or adopted in connection with the NE and PHE. The FAQs include eight questions related to the anticipated end of the “Outbreak Period” on July 10, 2023, which is 60 days after the end of the NE and PHE on May 11 (rules regarding the Outbreak Period are set forth in our earlier articles here and here). Below are the highlights:

Following the end of the PHE, plans and issuers can impose cost-sharing, prior authorization or other medical management requirements for COVID-19 diagnostic tests, although the Departments encourage plans not to do so.
Plans and issuers are encouraged to notify plan participants of changes regarding COVID-19 diagnosis, testing and treatment. Special rules apply under which Summaries of Benefits and Coverage (SBCs) need not be amended mid-year.
While plans and issuers will no longer be required to post prices for diagnostic tests furnished after May 11, they are nevertheless encouraged to do so.
Plans must continue to cover vaccines that qualify as preventive services, without cost-sharing, when provided in-network.
The FAQs provide examples relating to the application and termination of extended time periods for elections under the Consolidated Omnibus Budget Reconciliation Act (COBRA) and the Health Insurance Portability and Accountability Act (HIPAA).
In what is a welcome surprise, the FAQs confirm that individuals covered by a High-Deductible Health Plan (HDHP) will remain Health Savings Account (HSA)-eligible until further notice even if the HDHP in which they are enrolled provides medical care services and items purchased related to testing for and treatment of COVID-19 prior to the satisfaction of the HDHP’s applicable minimum deductible.

To keep employers apprised of the rules and to assist with providing notice to plan participants of the changes that will accompany the end of the NE and PHE, the Department of Labor has issued two blog posts, which are available here and here.

Action Items: We urge plan sponsors to pay particular attention to notifying employees of the upcoming changes that will accompany the end of the PHE and NE and to ensure that participants covered under an HDHP understand that they may continue to contribute to their HSAs. Employers should consider communicating these changes to their employees.

For any questions regarding the end of the PHE and/or NE, please contact your regular McDermott lawyer or one of the authors.

New 50-State Survey | ID Verification for Telemedicine Encounters

by McDermott Will & Emery | Mar 30, 2023 | Digital Health, Health and Welfare Plans

Verifying the identity of a patient prior to delivering telehealth services is important to prevent a range of potential risks, including the creation of fake accounts, insurance fraud and drug abuse/diversion.

A growing number of states and health plans require the verification of a patient’s identity. This verification activity has become a standard practice in the telehealth industry and is expected to continue.

Download our 50-state survey to learn which states require patient identity verification and access links to relevant state laws in one convenient place.

Download the report.

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