FDA seeks to restrict compounding of key GLP-1s

By Ella Jeffries – The FDA has proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, the latest move in a monthslong crackdown on the compounded GLP-1 market. The 503B bulks list identifies bulk drug substances outsourcing facilities can use in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act, according to an April 30 agency news release. In most cases, outsourcing facilities cannot compound drugs using bulk substances unless the substance appears on the list or the drug is on the FDA’s shortage list at the time of compounding, distribution and dispensing. Read Full Article...

HVBA Article Summary

1. FDA's Proposed Exclusion and Rationale: The FDA is considering removing semaglutide, tirzepatide, and liraglutide from the 503B bulks list, which would restrict outsourcing facilities from compounding these drugs unless they are on the official shortage list. The agency's review concluded there is no clinical necessity for compounding these medications from bulk substances at this time. This move is part of a broader effort to regulate the compounded GLP-1 market and ensure patient safety.

2. Industry Pushback and Legal Actions: Brand-name manufacturers such as Novo Nordisk and Eli Lilly have actively advocated for tighter restrictions on compounding these drugs. Novo Nordisk petitioned the FDA to exclude liraglutide, while Eli Lilly joined a lawsuit to prevent compounding pharmacies from challenging the FDA's determination regarding tirzepatide shortages. These actions reflect ongoing tensions between pharmaceutical companies, compounding pharmacies, and regulatory authorities over market access and drug availability.

3. Increased Enforcement and Market Impact: The FDA has recently increased enforcement, issuing guidance that pharmacies must stop compounding GLP-1 drugs once branded versions are no longer in shortage and sending warning letters to telehealth companies for misleading claims. Compounded GLP-1s have made up a significant portion of the U.S. supply in 2024, indicating the potential impact of these regulatory changes on patient access. The agency has also cited facilities for improper production practices, highlighting concerns about quality and sterility in compounded medications.

Consumer health data’s regulatory patchwork is growing. Relief isn’t coming.

By Michael Brady – The regulatory framework designed to protect patients’ health information is struggling to keep pace as patients increasingly share their health data with apps, wearables and AI tools — and the gap is widening. The federal government has stepped back from enforcing the Health Insurance Portability and Accountability Act, a two-decade-old law that protects consumer health information, just as state legislatures have accelerated their own privacy efforts, making compliance more fragmented and unpredictable, experts say. Read Full Article...

HVBA Article Summary

1. Fragmented Regulatory Landscape: The withdrawal of robust federal enforcement of HIPAA has led to a patchwork of state-level privacy laws, making compliance increasingly complex for healthcare organizations. States such as Connecticut, Maryland, Nevada, and Washington have enacted their own consumer health data privacy laws, each with varying requirements. This lack of uniformity means organizations must navigate a maze of overlapping and sometimes conflicting regulations depending on their location and the type of data they handle.

2. Patient Behavior Outpaces Regulation: As patients gain more access to their electronic health records and voluntarily share sensitive information with consumer-facing apps and AI tools, much of this data falls outside the scope of HIPAA and state laws. Many consumers may not fully understand the privacy risks associated with sharing their health data in unregulated environments. This trend increases the exposure of sensitive health information and highlights the need for greater patient education about data privacy.

3. No Imminent Federal Solution: Efforts to pass comprehensive federal legislation addressing consumer health data privacy have repeatedly stalled, largely due to disagreements over issues like state law preemption and private rights of action. Even expanding HIPAA would not eliminate the regulatory patchwork, as stricter state laws would still apply. In the absence of federal action, voluntary frameworks and state-level initiatives are likely to continue shaping the privacy landscape, requiring organizations to proactively monitor and adapt to evolving standards.

Specialty drugs now consume over half of total drug spend

By Kristen Smithberg – Employers and health plans continue to grapple with rising specialty drug costs as utilization growth and an expanding pipeline reshape benefit strategy, according to Pharmaceutical Strategies Group's 13th annual Specialty Drug Benefits Report, which surveyed benefits leaders across employers, health plans and union-sponsored plans nationwide. Specialty drugs now account for more than half of total drug spending despite serving a relatively small patient population, underscoring their outsized impact on benefit budgets, according to the report. When asked about top priorities, 43% of respondents cited managing specialty drug trend and costs as their primary focus, followed by 37% prioritizing total cost of care. Read Full Article... ^{_{(Subscription required)}}

HVBA Article Summary

1. Rising Specialty Drug Costs and Benefit Complexity: The increasing use and approval of specialty drugs are forcing employers and health plans to rethink their benefit strategies. As specialty drugs now make up the majority of drug spending, organizations are facing more complex decisions regarding coverage, formulary design, and cross-benefit coordination. This complexity is further heightened by the need to manage drugs that may be covered under both pharmacy and medical benefits.

2. Anticipated Impact of Cell and Gene Therapies (CGTs): A significant proportion of health plans and employers expect cell and gene therapies to pose major financial and administrative challenges in the near future. These therapies, while medically advanced, come with high costs and require careful management as they become more prevalent and gain broader indications. The anticipated growth in CGT claims is prompting payers to focus on both the financial risks and the operational demands of managing these treatments.

3. Shift in Rebate and Utilization Management Strategies: While rebates have traditionally been a key tool in managing specialty drug costs, there is a growing willingness among payers to accept fewer rebates in exchange for greater flexibility in utilization management. This shift indicates a move away from prioritizing rebate maximization toward implementing stricter clinical and coverage controls. The trend reflects a broader effort to balance cost containment with the need for effective oversight of high-cost therapies.

Why insurance data integration keeps breaking from the start

By Tim Bond – The benefits industry faces a data integration nightmare. The problem starts when files from employers, brokers, third-party administrators, insurers and other partners enter the data ecosystem. The root problem is always the same: Each player formats its data in a different way. Carriers onboard hundreds of employer groups every year. Read Full Article... ^{_{(Subscription required)}}

HVBA Article Summary

1. Persistent Data Variability: Despite the existence of industry standards such as X12, ACORD, and LDEx, significant variability remains in how organizations format and transmit data. This inconsistency leads to complex onboarding processes and frequent exceptions, requiring carriers and intermediaries to maintain both standards-based and flexible data ingestion systems. The lack of uniformity increases manual intervention and operational inefficiency across the benefits ecosystem.

2. Manual Remediation and Its Consequences: When data files are incomplete or formatted incorrectly, organizations often resort to manual remediation using spreadsheets, emails, and repeated uploads. This approach results in long turnaround times, delayed ID cards, stalled claims, and increased call volumes from frustrated members. The focus on fixing errors after the fact diverts resources from process improvement and innovation, perpetuating the cycle of inefficiency.

3. Strategies for Effective Integration: Teams that succeed in data integration design for variability from the outset, building flexible frameworks that can map diverse formats to a common model and apply consistent validation rules. Empowering business users to manage eligibility logic and validation criteria without developer intervention streamlines operations. Additionally, providing partners with real-time dashboards and self-service portals enhances transparency, accountability, and trust, allowing organizations to scale support without increasing headcount.

3 barriers to GLP-1 adherence — and how systems are overcoming them

By Ella Jeffries – Health systems are finding that the biggest challenge with GLP-1 medications isn’t starting patients on therapy — it’s keeping them on it. During a panel at Becker’s Spring Chief Pharmacy Officer Summit, pharmacy and physician leaders said adherence has emerged as one of the most persistent gaps tied to GLP-1 use, with implications for both patient outcomes and long-term costs. “If we do not have that discussion, then you put a patient on an expensive, life-changing medication and they’re not adherent,” Girish Kaimal, PharmD, vice president of pharmacy at Parkview Health in Fort Wayne, Ind., said. Read Full Article...

HVBA Article Summary

1. Early Discontinuation of Therapy: Many patients stop GLP-1 therapy within the first year, with discontinuation rates exceeding 60% in some groups, especially among those without diabetes. Common reasons for early discontinuation include high costs, side effects, and insufficient ongoing support. Health systems are addressing this by implementing structured onboarding processes, such as scheduled follow-ups and pharmacist check-ins, to help patients navigate the initial treatment period and improve adherence.

2. Need for Continuous, Coordinated Care: Traditional care models that treat GLP-1 prescriptions as one-time transactions are proving inadequate for sustained patient adherence. Organizations are expanding the role of pharmacists and integrating care teams to provide ongoing support, manage dose adjustments, and ensure regular follow-up. Digital tools like patient portals and automated reminders are also being used to maintain engagement and identify adherence issues early.

3. Financial and Side Effect Barriers: Affordability remains a significant obstacle, as insurance coverage for GLP-1 medications varies and out-of-pocket costs can be high. Health systems are responding by offering financial navigation support and helping patients access assistance programs. Additionally, proactive management of side effects, such as nausea and vomiting, is being prioritized to help patients remain on therapy, though the long-term outcomes of discontinuation are still uncertain.

How to raise broker comfort with ICHRAs

By Bruce Shutan – The number of individual coverage health reimbursement arrangements known as ICHRAs has soared by more than 1,000% over the past five years, with participation tripling between 2024 and 2025, according to the HRA Council. While employers generally have been reluctant to embrace this emerging model, ICHRA adoption is accelerating as they search for more predictable healthcare costs, notes Brandy Thompson, founder and CEO of benefitbay, which has been offering ICHRAs since April 2021. Read Full Article... ^{_{(Subscription required)}}

HVBA Article Summary

1. Rapid Growth and Employer Interest: ICHRAs have experienced significant growth in recent years, with a notable increase in both the number of arrangements and employee participation. This surge is largely attributed to employers seeking more predictable and manageable healthcare costs. The data suggests that as employers become more familiar with ICHRAs, their willingness to adopt this model increases, especially in the face of rising group health plan renewals.

2. Broker Hesitancy and Communication Challenges: Despite growing employer interest, many brokers remain hesitant to recommend ICHRAs due to their differences from traditional group health insurance. Brokers often express concerns about the complexity and perceived risks associated with ICHRAs, which can dampen employer enthusiasm. Effective communication and education are essential to help brokers understand the benefits and operational aspects of ICHRAs, thereby increasing their comfort level with the model.

3. Importance of Human Support and Change Management: Successful implementation of ICHRAs relies heavily on providing personalized support and clear change management strategies for employees. Platforms that prioritize human interaction over automated solutions tend to achieve higher satisfaction rates and smoother transitions. Ensuring that employees understand their options and the reasons behind the shift to ICHRAs is crucial for minimizing resistance and maximizing the benefits of the new arrangement.

Patients are Turning to HCP Influencers in the Age of AI and Misinformation

By Adam Goodcoff – Americans are undergoing a generational shift in how we consume health information. Despite having more access to information than ever before through Google Search and other online resources, patients are more misinformed than ever, an issue that is sometimes made worse by medically questionable outputs driven by generative AI. Because of that, patients are turning to real humans, clinicians, and trusted voices — often referred to as healthcare provider (HCP) Influencers — on social media, ushering in a new generation of healthcare content creators. Read Full Article...

HVBA Article Summary

1. Rise of HCP Influencers Amid Misinformation: As patients face increasing amounts of health misinformation online, many are turning to healthcare provider (HCP) influencers on social media for guidance. These influencers, often clinicians themselves, are filling a gap left by overwhelmed primary care physicians who struggle to keep up with patient inquiries. The trend highlights a shift in how health information is consumed and trusted in the digital age.

2. Regulatory Scrutiny and the Need for Clear Guidelines: Recent FDA actions against telehealth and compounding companies indicate that regulatory oversight of health communication on social media is intensifying. Physicians and healthcare communicators are seeking clear rules and best practices for sharing medical information online. Until specific guidance is issued, clinicians are advised to adhere to existing legal and ethical standards, including transparent disclosure of partnerships and sponsored content.

3. Trust in Clinicians Remains Strong Despite AI Growth: Even with the widespread adoption of AI tools for health information, studies show that patients overwhelmingly trust their own doctors above other sources. However, due to administrative burdens and limited time, many physicians cannot always respond promptly, pushing patients toward online platforms. This dynamic underscores the importance of supporting clinicians in their digital outreach and ensuring patients have access to reliable, accurate health information.