FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions

By Frank Vinluan - For many people, the end of the year is a mad rush to wrap things up before the holidays, and so it was for the FDA. Notable regulatory decisions include the first drug approval for a prevalent chronic condition and a novel regenerative medicine approach to help trauma patients. In one case, a new drug approval comes as its developer takes on a new identity in the new year.  Read Full Article… 

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1. Notable Firsts:

   • Eli Lilly's Zepbound becomes the first FDA-approved drug for obstructive sleep apnea, addressing a chronic condition historically managed with medical devices.

   • Ionis Pharmaceuticals gains FDA approval for Tryngolza, a genetic medicine for familial chylomicronemia syndrome, marking its first solo commercialized product.

   • Humacyte's Symvess offers a bioengineered blood vessel option for limb-saving surgeries, while Mesoblast's Ryoncil secures long-awaited approval for treating acute graft-versus-host disease in pediatric patients.

2. Approvals Across Therapeutic Areas:

   • Immunology: Organon's Vtama and Galderma's Nemluvio expand options for treating atopic dermatitis, serving both adults and children.

   • Rare Diseases: Neurocrine’s Crenessity for congenital adrenal hyperplasia and Novo Nordisk's Alhemo for hemophilia A and B diversify treatment landscapes.

   • Cancer: New approvals include Merus’s Bizengri for NRG1 gene fusion cancers, AstraZeneca’s Imfinzi for limited-stage small cell lung cancer, and Vertex’s Alyftrek for cystic fibrosis, among others.

3. Regulatory Challenges and Setbacks:

   • Astellas Pharma faces rejection for less-frequent dosing of Izervay and safety warnings for Veozah.

   • Applied Therapeutics encounters rejection and a warning letter for govorestat.

   • Intercept Pharmaceuticals' Ocaliva endures mounting regulatory hurdles, including FDA and EU setbacks.

   • Zealand Pharma, Lexicon Pharmaceuticals, and J&J receive rejections or requests for additional data, highlighting the challenges in gaining regulatory approval.

Regulators plan to restart HIPAA health data privacy and security audits

By Allison Bell - Federal regulators want to begin a new wave of health information privacy and data security audits, according to attorneys at Foley & Lardner. The U.S. Department of Health and Human Services has defined benefits brokers, benefits consultants and benefit plan administrators as "business associates" of "covered entities" for purposes of enforcing the Health Insurance Portability and Accountability Act health information requirements. Read Full Article… ^{_{(Subscription required)}}

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1. Expanded HIPAA Audit Scope and Implications for Brokers: The HHS Office for Civil Rights is preparing to recommence HIPAA audits with an expanded scope beyond the 2016-2017 audits, which previously covered only a fraction of HIPAA requirements and had minimal focus on data security. This renewed focus could impact benefits brokers and consultants, exposing them to heightened scrutiny, potential fines, and the need for rigorous compliance efforts.

2. Opportunities and Risks of HIPAA Audits for Cybersecurity: While new HIPAA audits aim to improve compliance and safeguard against cybersecurity threats like ransomware, they also present challenges. Firms may need to invest in comprehensive risk analyses, implement robust privacy and security policies, and train staff to meet enhanced audit expectations. These measures could mitigate risks but require significant preparation.

3. Political and Legislative Momentum for Data Security: With bipartisan support for data security improvements, such as the American Privacy Rights Act of 2024, HIPAA compliance efforts are likely to persist regardless of administration changes. This legislative backdrop signals sustained emphasis on protecting sensitive health data, further underscoring the importance of proactive compliance by covered entities and business associates.

Here are new state healthcare laws taking effect in 2025

By Hayley Desilva - Providers and insurers in several states will have to grapple with health-related laws taking effect in 2025. Most of the legislation concerns reproductive care and insurance coverage. Read Full Article… ^{_{(Subscription required)}}

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1. Expanded Healthcare Coverage and Patient Protections: Several states, including Colorado, Illinois, and Minnesota, are introducing laws to broaden healthcare access and patient protections. Colorado now provides Medicaid coverage to all pregnant individuals and children, regardless of immigration status. Minnesota caps copays on essential medications and medical supplies while mandating expanded insurance coverage for abortion services, gender-affirming care, and biomarker testing. Illinois is expanding prescription drug coverage and empowering social workers and pharmacists to administer certain treatments for mental health and substance abuse.

2. Enhanced Reproductive and Family Planning Support: New laws in states like California, Delaware, and Minnesota are focused on reproductive health and family planning. California is redefining infertility and mandating fertility treatment coverage, while Minnesota expands insurance coverage for wigs due to health issues and enhances abortion access. Delaware requires Medicaid and private insurers to cover abortion services up to $750 and is increasing behavioral health support in schools.

3. Healthcare Workforce and Cybersecurity Measures: Workforce-focused legislation in Washington and Delaware emphasizes better working conditions and mental health support. Washington's updated overtime prohibition law includes a broader range of healthcare employees, while Delaware is mandating behavioral health professionals in schools. Connecticut takes a cybersecurity-focused approach, requiring annual audits and response plans for hospitals to safeguard against digital threats.

Seniors won’t pay more than $2,000 for drugs at the pharmacy starting in January

By Tami Luhby - Medicare beneficiaries who take a lot of pricey medications will get a big break in 2025. That’s when the $2,000 annual cap on out-of-pocket costs for drugs bought at the pharmacy or through mail order takes effect. Read Full Article…

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1. Introduction of a $2,000 Out-of-Pocket Cap: The Inflation Reduction Act established a $2,000 annual limit on out-of-pocket prescription drug expenses for Medicare Part D enrollees starting in 2025. This cap replaces the uncapped catastrophic coverage phase, providing significant financial relief to more than 3 million beneficiaries initially, with projected savings of $1,000 or more annually for about 40% of those reaching the limit.

2. Additional Provisions to Lower Costs: The law includes a $35 monthly cap on insulin, no-cost vaccines for Medicare beneficiaries, rebates for price hikes exceeding inflation, and the ability for Medicare to negotiate certain drug prices. It also allows enrollees to spread payments across the calendar year to better manage early-year expenses, although awareness of these provisions remains low among voters.

3. Impact on Premiums and Insurer Responsibilities: Insurers will shoulder a larger share of drug costs in the catastrophic phase, leading to proposed premium hikes. To mitigate this, the Biden administration plans to provide insurers with up to $5 billion in subsidies in 2024. However, these subsidies do not apply to Medicare Advantage plans, which may adjust premiums and benefits more flexibly.

Balancing the economic value of workplace benefits

By Patrick Leary - When developing employee benefits strategies, employers and benefits advisors must balance the realities of today’s business environment with the desire to offer a comprehensive benefits package to attract and retain workers. While the economic outlook across most industries is promising, inflation and other cost pressures impact an employer’s ability to offer a robust suite of benefits. Read Full Article… ^{_{(Subscription required)}}

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1. Cost Management Strategies: Employers are taking proactive steps to address rising benefit costs, with strategies such as negotiating better terms with providers (55%), adjusting plan features (43%), switching providers (31%), and eliminating underutilized benefits (30%). These efforts aim to balance cost efficiency with the need to provide competitive and meaningful benefits to attract and retain talent.

2. Economic Value Focus: Both employers and benefits advisors are increasingly emphasizing the economic value of benefits programs. Employers are demanding data-driven insights and clear ROI for their investments, prompting advisors to align their recommendations with measurable outcomes that benefit all stakeholders — employers, employees, and advisors themselves.

3. Future of Benefits: As the competition for talent intensifies, the ability to deliver workplace benefits that combine meaningful value and cost-effectiveness will define success. Adaptability and alignment with evolving workforce needs are essential for creating benefits programs that resonate with today’s and tomorrow’s employees.

AI in healthcare: What to expect in 2025

By Ron Southwick - Artificial intelligence emerged as one of the leading issues in healthcare and dominated conversations at health technology conferences over the past year. In 2025, expect AI to remain a prime area of attention in the healthcare industry. Read Full Article…

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1. Incremental AI Adoption and Value Realization: Healthcare leaders predict a continued, cautious adoption of AI technologies, emphasizing a shift from theoretical capabilities to practical value. This includes a focus on workflow automation, data processing, and administrative support, allowing organizations to build confidence in AI’s role before full clinical integration.

2. Enhanced Patient Care and Diagnostic Precision: AI is projected to play a transformative role in patient care by improving diagnostic accuracy, streamlining clinical decision-making, and supporting personalized medicine. Tools such as AI-powered diagnostics, language models for patient communication, and predictive analytics are expected to improve care quality and efficiency.

3. Operational Efficiency and Burnout Reduction: AI technologies will drive significant improvements in operational efficiency by automating routine tasks such as billing, coding, and revenue cycle management. This will reduce administrative burdens, support financial health, and alleviate clinician burnout, enabling more focus on direct patient care and improving overall job satisfaction.

Employers take fights with Big Pharma and PBMs over insulin price-gouging charges to one federal court

By Allison Bell - A federal judge in New Jersey is now in charge of coordinating the pretrial action for a giant group of lawsuits filed on behalf of patients, employer health plan sponsors and state attorneys general who are angry about the cost of insulin. Read Full Article… ^{_{(Subscription required)}}

HVBA Article Summary

1. Discovery and Class-Action Certification: The discovery process in the Insulin Pricing Litigation could unveil critical insights into how drug manufacturers and pharmacy benefit managers (PBMs) influence insulin pricing strategies. Lawyers for the plaintiffs may use this evidence to support their requests for class-action certification, potentially shedding light on the financial impact of alleged questionable activities on self-funded employer plans.

2. Insulin Pricing Disparities: Insulin prices in the United States remain significantly higher than in other countries, with retail costs reaching approximately $300 per month. Efforts like the Biden administration's Medicare cost caps aim to mitigate these expenses, but the plaintiffs allege that manufacturer-PBM collaborations artificially inflate insulin prices, leading to substantial out-of-pocket costs for some patients.

3. Multidistrict Litigation Framework: The Insulin Pricing Litigation has been consolidated into a multidistrict litigation proceeding under Judge Brian Martinotti. The case involves three tracks: state attorneys general, third-party payers, and self-funded employer plans. This structure aims to streamline the pretrial process, with the potential for significant rulings or settlements influencing the broader pharmaceutical industry.