Health and Welfare Plans Archives - EMPLOYEE BENEFITS BLOG

Imported Drugs: (Possibly) Coming Soon to a State Near You

by James Ravitz, Paul Gadiock, Marissa Hill Daley, Nathan Gray and Karis Jackson | May 16, 2024 | Employee Benefits, Health and Welfare Plans

In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from the US Food and Drug Administration (FDA) for importation programs under Section 804 of the Federal Food, Drug, and Cosmetic Act (FDCA) to import prescription drugs from Canada. These “Section 804 Importation Programs” (SIPs), if approved, would enable states to import prescription drugs from Canada, often at significantly lower prices than those available in the United States.

After years of legal and other challenges to the rule, on January 5, 2024, the FDA authorized Florida’s SIP proposal. While eight other states have laws that permit drug importation, and six of them are seeking FDA approval, this is the first time that the FDA has approved a state entity to import drugs from another country. Following Florida’s example, Colorado and other states are moving forward with their own SIP plans.

Read more here.

Medicare Coverage of Wegovy Raises Questions Regarding the Affordability and Accessibility of Novel Medications

by Jeffrey Davis, Paul Radensky, Parashar Patel and Amy Kelbick | May 15, 2024 | Employee Benefits, Health and Welfare Plans

The Centers for Medicare & Medicaid Services (CMS) announced in March that it would allow health plans under Medicare Part D (the Medicare prescription drug benefit) to cover Wegovy and other weight-loss medications if they receive Food and Drug Administration (FDA) approval for an additional medically accepted indication.

In Wegovy’s case, the FDA recently approved an additional indication “to reduce the risk of major cardiovascular events (such as cardiovascular death, non-fatal myocardial infarction, or non-fatal strokes) in adults with established cardiovascular disease and either obesity or overweight” in combination with a reduced caloric diet and increased physical activity. As a result, Wegovy can be available for Medicare beneficiaries who have an established cardiovascular disease and are either overweight or obese. Part D coverage is still not available for weight-loss medications in beneficiaries who do not have the additional medically accepted indication.

Read more here.

OCR Update on Tracking Technologies Provides Little Relief for HIPAA-Regulated Entities

by Jennifer S. Geetter, David Quinn Gacioch, Elliot R. Golding, Daniel F. Gottlieb, Ryan S. Higgins and Edward G. Zacharias | May 14, 2024 | Digital Health, Employee Benefits, Health and Welfare Plans, Privacy and Data Security

On March 18, 2024, the US Department of Health and Human Services Office for Civil Rights (OCR) issued an update to its December 1, 2022, bulletin titled “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates.” In releasing the 2024 update, OCR stated that its purpose was to “increase clarity for regulated entities and the public.” While the update appears to narrow the scope of what OCR considers to be HIPAA-protected health information (PHI) in the context of online tracking technologies, it largely reconfirms prior guidance in the 2022 bulletin and will likely have limited practical impact for HIPAA-covered entities and business associates that have already heeded the 2022 bulletin.

Read more here.

IRS Announces 2025 Limits for Health Savings Accounts, High-Deductible Health Plans and Excepted Benefit HRAs

by Jacob Mattinson, Sarah Raaii and Alden Bianchi | May 9, 2024 | Employee Benefits, Health and Welfare Plans

The Internal Revenue Service (IRS) recently announced (see Revenue Procedure 2024-25) cost-of-living adjustments to the applicable dollar limits for health savings accounts (HSAs), high-deductible health plans (HDHPs) and excepted benefit health reimbursement arrangements (HRAs) for 2025. All of the dollar limits currently in effect for 2024 will change for 2025, with the exception of one limit. The HSA catch-up contribution for individuals ages 55 and older will not change as it is not subject to cost-of-living adjustments.

See the adjustments here.

CMS Releases FY 2025 IPPS Proposed Update

by McDermott Will & Emery | May 9, 2024 | Employee Benefits, Health and Welfare Plans

On April 10, 2024, the Centers for Medicare & Medicaid Services (CMS) posted the Hospital Inpatient Prospective Payment System (IPPS) proposed update for fiscal year (FY) 2025, along with proposed policy and regulation changes. The proposed rule would update Medicare payment policies and quality reporting programs relevant for inpatient hospital services, and build on key agency priorities, including advancing health equity and improving the safety and quality of care.

Access full analysis.

Congress Likely to Kick the Can on COVID-Era Telehealth Policies

by Debra Curtis | May 8, 2024 | Employee Benefits, Health and Welfare Plans

Congressional lawmakers must soon decide to continue or end payment changes for telehealth services enacted during the COVID-19 pandemic. However, according to this KFF Health News article, Congress will likely “kick the can” past the November election.

Access the article.

340B Remedy Rule and Medicare Advantage Rates: Navigating Shifting Payments

by Emily J. Cook and Emily Curran | May 7, 2024 | Employee Benefits, Health and Welfare Plans

On April 1, 2024, the Centers for Medicare & Medicaid Services (CMS) released the Announcement of Calendar Year (CY) 2025 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, otherwise known as the rate announcement. The rate announcement is released annually and includes updates to the methodologies used to calculate MA plan payments, as well as other payment policies that impact Part D. The CY 2025 rate announcement finalizes the policies proposed in CMS’s January 2024 advance notice.

Read more here.

Indiana Enacts New Law Requiring Notice of Healthcare Transactions

by Callee Donovan and Sarah Kitchell | May 1, 2024 | Employee Benefits, Health and Welfare Plans

On March 13, 2024, Indiana enacted Senate Bill No. 9, which establishes that the Office of the Indiana Attorney General must receive prior written notice of certain transactions involving Indiana healthcare entities. This new law goes into effect July 1, 2024, and has a more expansive reach than many of its peer transaction notice laws. It expressly identifies private equity firms as qualifying entities, applies to a broad scope of transactions and sets a lower threshold for reportable transactions than other states at $10 million. Indiana has not yet promulgated regulations, rules or guidance related to the law.

Parties interested in Indiana’s healthcare landscape should closely monitor developments, as the $10 million threshold and broad definition of “health care entities” is likely to capture healthcare transactions that previously would not have been subject to review.

Read more here.

CMS Issues Guidance on Usage of AI in Making Coverage Determinations

by McDermott Will & Emery | Apr 25, 2024 | Employee Benefits, Health and Welfare Plans

On February 6, 2024, the US Centers for Medicare & Medicaid Services (CMS) issued a letter to all Medicare Advantage (MA) organizations and Medicare-Medicaid plans. The letter covered frequently asked questions and answers related to the coverage criteria and utilization management requirements in the CMS Final Rule issued on April 5, 2023.

Among the FAQs was guidance related to the use of artificial intelligence (AI) and other technologies to assess coverage decisions. CMS wrote, “An algorithm or software tool can be used to assist MA plans in making coverage determinations, but it is the responsibility of the MA organization to ensure that the algorithm or artificial intelligence complies with all applicable rules for how coverage determinations by MA organizations are made.” For example, in a decision to terminate post-acute care services, an algorithm or software tool can be used to predict the potential length of stay, but that prediction alone cannot be used as the basis to terminate services.

CMS also expressed concern that algorithms and AI technologies can exacerbate discrimination and biases, emphasizing that MA organizations must comply with nondiscrimination requirements of Section 1557 of the Affordable Care Act.

2024 Chart of Healthcare Regulations

by Kristen O'Brien, Rachel Stauffer, Katie Waldo and Jeffrey Davis | Apr 24, 2024 | Employee Benefits, Health and Welfare Plans

During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies.

This chart displays health-related regulations that may be issued this year, organized by federal agency and date of potential release.

Access the chart.