On April 26, 2024, the Federal Trade Commission (FTC) issued a final rule to amend its Health Breach Notification Rule (HBN Rule). The HBN Rule works as a compliment and counterpart to the breach notification requirements established under the Health Insurance Portability and Accountability Act (HIPAA) for HIPAA-regulated entities. Specifically, the HBN Rule requires that vendors of personal health records (PHRs) and related entities that are not covered by HIPAA notify individuals, the FTC and, in some cases, media outlets of a breach of unsecured personally identifiable health data. Stakeholders should carefully review the final rule to understand how organizations will be impacted.
In a recent article in Managed Healthcare Executive, Peter Wehrwein examines the trend of self-funding of group health benefits by smaller employers who used to depend mainly or entirely on fully insured programs.
The shift to self-funding, the article explains, is grounded in the Employee Retirement Income Security (ERISA), which exempts self-funded plans from state health insurance mandates, and in the Affordable Care Act, which strictly regulates small group and individual health insurance policies. Wehrwein presents the issues from the perspective of state and federal policymakers and regulators, which the article characterizes as “worrisome.” But what of the perspective of small employers?
Healthcare costs are rising at rates that are well in excess of the growth of real gross domestic product. This appears unsustainable, but these costs nevertheless keep climbing inexorably. For employers, the pressure to do something is compelling.
The article claims that self-funding is more expensive than fully insured coverage. But compared to what fully insured coverage, exactly? By definition, many small employers can only purchase coverage in the small-group market. This is, however, the very market these same employers are fleeing, and they are doing so precisely because it is too expensive. Indeed, the prohibitive cost of small-group market coverage is why individual coverage Health Reimbursement Arrangements have failed to gain widespread acceptance, particularly in large urban environments.
Wehrwein correctly identifies two options for self-funding: group medical captives and level funding, both of which he views as problematic. Small employers appear to disagree, however, based on their actions. In their view, these options instead represent viable options in their quest to provide competitive group health coverage to their employees. The two options for self-funding identified in the article are fundamentally different solutions that are appropriate for different cohorts of small employers.
Group Medical Captives (50 – 200 Covered Lives)
The term “captive” insurer traditionally referred to a “single parent” captive, which is a subsidiary of an operating company/parent that insures the risks of the operating company/parent and in some instances its affiliates. Historically, single-parent captives insured property and casualty risks and workers’ compensation, but they have more recently been pressed into service to cover employee welfare plan risks.
A group captive allows a group of unrelated employers to form a collective insurance company to manage some portions of their risks. Where, as is the case here, the risk is most often medical stop-loss coverage, the arrangement is referred to colloquially as a “medical stop-loss group captive.” For an extended discussion of medical stop-loss group captive funding arrangements and their accompanying legal and regulatory issues, please see our Special Report.
There is some debate over what size employer might most benefit from participation in a medical stop-loss group captive. While the conventional wisdom is that 200 covered lives is the sweet spot, credible estimates go as low as 50 covered lives. Whatever the appropriate number, medical stop-loss captives can in the right circumstances offer substantial savings when compared to fully insured coverage. [...]
The US Department of Health and Human Services Office for Civil Rights (OCR) recently reached a $4.75 million settlement with a New York City hospital for alleged violations of the Health Insurance Portability and Accountability Act (HIPAA).
According to OCR, in 2013, a former hospital employee sold the electronically protected medical records of 12,517 patients to an identity theft group, and the NYC hospital did not detect or report the breach to OCR until 2015. OCR’s investigation found several potential HIPAA violations, and in addition to the settlement, the hospital agreed to conduct a thorough security risk assessment, revise HIPAA policies, provide additional training to staff, begin recording and tracking all electronic health record (EHR) activity to monitor who is accessing patient information, and create a risk management plan. OCR will also monitor the hospital for two years for compliance with HIPAA.
Companies are taking a fresh look at their privacy policies in the wake of Dobbs v. Jackson Women’s Health Organization. According to this Law360 article, policymakers are putting more pressure on companies to tighten their restrictions on collecting and disclosing personal health and location data.
What are the opportunities and challenges of digital health wellness programs? In a recent discussion, McDermott Partners Scott A. Weinstein and Sarah G. Raaii discussed a wide range of issues, including accessibility to employees, navigating the health plan regulatory landscape, budgetary constraints and the reality of rising healthcare costs.
The US Department of Health and Human Services Office for Civil Rights (OCR) recently announced a settlement with a community hospital resolving an investigation under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy and security rules. While the settlement involved a medical provider, it offers some important lessons for other HIPAA-covered entities, including employer-sponsored group health plans.
The settlement involved impermissible data breaches by non-medical staff who, allegedly, used their login credentials to access patient medical records maintained in the hospital’s electronic medical record system without a job-related purpose. The lesson here is straightforward: all HIPAA-covered entities must “protect the privacy and security of health information.”
The HIPAA privacy and security rules are complex, and full compliance requires substantial resources that are, as a practical matter, beyond the reach of many organizations. While OCR routinely refers to these rules as “scalable,” that claim is difficult to square with our experience. Full compliance with the particulars of the rule is costly and time-consuming, and it requires no shortage of expertise. Thankfully, in practice, OCR tends to focus its investigative resources on certain features of these rules. These features include the following items which covered entities must perform to comply:
Conduct an accurate and thorough risk analysis to determine risks and vulnerabilities to electronic protected health information;
Develop and implement a risk management plan to address and mitigate identified security risks and vulnerabilities identified in the risk analysis;
Develop, maintain and revise, as necessary, written HIPAA policies and procedures;
Enhance HIPAA and security training programs to provide workforce training on the updated HIPAA policies and procedures; and
Review relationships with vendors and third-party service providers to identify business associates and obtain business associate agreements with business associates if not already in place.
Where group health plans are concerned, fully insured plans routinely rely on their carriers for HIPAA compliance, which requires that plan sponsors get only “summary” health information at renewal. This option is not available to self-funded plans, however, even those that contract with a carrier for administrative services. Employers in this latter category should be reasonably confident of surviving an OCR audit or investigation only, at a minimum, by taking the actions listed above.
At a recent open Commission meeting, the Federal Trade Commission (FTC) voted unanimously to issue a Notice of Proposed Rulemaking to amend the Health Breach Notification Rule (HBNR). The FTC’s proposed amendment aims to codify the HBNR’s application to digital health and mobile technologies. However, several aspects of the proposed amendment lack clarity and are likely to cause confusion unless further clarified through the ongoing rulemaking process.
The Biden administration previously 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 series introduction for more information). On April 10, 2023, President Biden signed a resolution moving up the end of the NE to April 10, 2023 (the PHE ended on May 11). The US Departments of Labor (DOL), Health and Human Services, and the Treasury (the Departments) issued a set of FAQs (available here) on March 29, 2023 (FAQs), which anticipated that the NE would end on May 11, 2023 (see our prior article explaining the FAQs). Plan sponsors should continue to treat May 11 as the end of the NE consistent with the FAQs until the Departments say otherwise.
During the COVID-19 pandemic, the Departments provided relief from certain benefit plan deadlines, including:
The minimum 60-day election period for the Consolidated Omnibus Budget Reconciliation Act (COBRA) continuation coverage.
The date for making COBRA premium payments (45 days for the initial, then minimum 30-day grace periods).
The date for individuals to notify the plan of certain qualifying events (divorce, dependent child aging out of plan coverage) or determination of disability as it relates to COBRA coverage.
The date for providing a COBRA election notice (typically within 14 days after the plan receives notice of a qualifying event).
The 30-day period (or 60-day period, if applicable) to request Health Insurance Portability and Accountability Act (HIPAA) special enrollment.
The date within which individuals may file a benefit claim or an appeal of an adverse benefit determination under a plan’s claims procedures.
The date within which claimants may file a request for an external review after receipt of an adverse benefit determination or final internal adverse benefit determination.
This article discusses how the affected tolled deadlines will be phased out and what actions employers may need to take.
BACKGROUND
EBSA Disaster Relief Notice 2020-01, later extended by EBSA Disaster Relief Notice 2021-01, provided that the deadline by which action needs to be taken for the events described above was tolled until the earlier of: (i) one year from the date the deadline would have first started running for that individual or (ii) sixty (60) days from the end of the NE (the Outbreak Period). This guidance created a tolling deadline specific to each affected individual. Where the individual has not reached the one-year anniversary of the date of the initial deadline, timeframes will begin to run again sixty (60) days after the end of the NE (i.e., July 10, 2023).
The FAQs released by the Departments at the end of March provided much-needed clarification and various helpful examples for employers of how the outbreak period should be taken into consideration when calculating the tolled deadlines. For example, if an employee experiences a qualifying event under COBRA and loses coverage on April 1, 2023, the deadline for the individual to make a COBRA election is tolled until the earlier [...]
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.
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.
Subscribe
