Senate, FTC cracking down on pharma patent shenanigans

By Dick Durbin and Lina M. Khan - Why do Americans pay so much more for common medications than people in other countries? Why does an inhaler that costs $7 in France cost almost $500 in the United States? These are just a few of the questions the Senate Judiciary Committee looked to answer in a recent hearing. The common answer? Dominant corporations use a variety of patent-related strategies to protect their power, maximize their profits, and squash their competition. Read Full Article…

HVBA Article Summary

1. Pharmaceutical Manipulation of Patents: Pharmaceutical companies have exploited the FDA's Orange Book system by improperly listing patents, thereby delaying the approval of generic drugs. This tactic automatically grants a 30-month freeze on generic competition without proper scrutiny, allowing companies to maintain high prices by listing trivial patents for non-essential components, such as dose counters or inhaler caps. This practice has significantly contributed to the affordability crisis in the medication market.

2. Government Actions and Legislative Measures: In response to these exploitative practices, significant steps have been taken by the government. The Inflation Reduction Act of 2022 capped insulin prices for Medicare beneficiaries, saving them an average of over $300 annually. Additionally, the Senate Judiciary Committee has advanced bipartisan bills targeting anticompetitive practices, such as pay-for-delay agreements and excessive secondary patents. These legislative efforts aim to dismantle barriers to fair competition and reduce prescription drug prices.

3. FTC's Enforcement Actions and Successes: The Federal Trade Commission (FTC) has actively challenged improper patent listings to promote generic competition and lower drug prices. In November 2023, the FTC's actions led to the delisting of over 100 improper patents, resulting in major asthma inhaler manufacturers capping out-of-pocket costs at $35. The FTC continues to address these issues, having recently challenged more than 300 additional bogus patent listings, including those for popular weight loss and diabetes drugs. These efforts are crucial in ensuring that intellectual property laws foster innovation rather than stifle competition.

Lack of Affordability Tops Older Americans’ List of Health Care Worries

By Judith Graham - What weighs most heavily on older adults’ minds when it comes to health care? The cost of services and therapies, and their ability to pay. Read Full Article…

HVBA Article Summary

1. Rising Healthcare Costs and Senior Anxiety: Many seniors, like Connie and James Colyer of Kentucky, face significant anxiety over affording healthcare due to escalating costs. This issue is exacerbated by the rising expenses of housing, food, and other essentials, placing a heavy financial burden on older adults living on fixed incomes.

2. Research Highlights Financial Concerns: A survey by the University of Michigan's National Poll on Healthy Aging reveals that the top concerns among people aged 50 and older are the costs of medical care, long-term care, and prescription drugs. Over half of the 3,300 respondents reported being "very concerned" about these expenses, underscoring the widespread worry about healthcare affordability among seniors.

3. Limited Coverage and Unmet Needs: Traditional Medicare doesn't cover several essential services like dental and vision care, leading to significant out-of-pocket expenses for seniors. Nearly a third of seniors struggle to pay healthcare costs, and many forgo necessary care due to financial constraints. Assistance through Medicare Savings Programs and recent policy changes, such as the 2022 Inflation Reduction Act, offer some relief, but gaps in coverage remain a critical issue for the aging population.

Terminated BCBS Tennessee employee wins COVID vaccine mandate case

By Jakob Emerson - A federal jury has awarded a former BlueCross BlueShield of Tennessee employee nearly $700,000 after she was terminated for refusing to get vaccinated against COVID-19 in 2021. Read Full Article…

HVBA Article Summary

1. Federal Judge's Ruling: On June 28, a federal judge in the Eastern District of Tennessee ruled that the former employee of BlueCross BlueShield of Tennessee (BCBST) had a sincerely held religious belief that justified her refusal to receive the COVID-19 vaccination. The court determined that BCBST failed to provide a reasonable accommodation for her religious beliefs and could not prove that accommodating her beliefs would cause undue hardship to the company.

2. Employee Background and Termination: The former employee had worked with BCBST from 2005 to 2021 as a biostatistical research scientist, primarily working independently from home and rarely interacting directly with clients. In 2021, BCBST mandated COVID-19 vaccination as a condition of employment. The employee's request for a religious exemption was denied, leading to her termination for noncompliance with the mandate.

3. Jury Award and Company Response: The jury awarded the former employee $687,240 in damages, including back pay, compensatory damages, and punitive damages. BCBST expressed disappointment with the decision, maintaining that their vaccine requirement was legally compliant and necessary for employee and member safety. In addition to this case, BCBST faces a class action lawsuit filed in September 2023 by other former employees who allege their religious rights were similarly violated by the vaccination mandate.

Biden, Sanders call out Novo Nordisk, Eli Lilly for high drug costs in op-ed

By Joseph Choi - President Biden and Sen. Bernie Sanders (I-Vt.) continued their calls for lowered drug pricing in an op-ed published Tuesday, citing the high cost of the weight loss products manufactured by Novo Nordisk and Eli Lilly. Read Full Article…

HVBA Article Summary

1. Criticism of High Drug Prices: In a USA Today op-ed, President Biden and Senator Sanders criticized drug companies for charging significantly higher prices for prescription drugs in the U.S. compared to other countries. They highlighted that Americans pay up to six times more for medications like Novo Nordisk’s Ozempic and Wegovy, and Eli Lilly’s Mounjaro, than patients in Canada and Germany.

2. Actions Taken and Proposed Solutions: Biden and Sanders acknowledged the steps taken by the Biden administration, such as the Inflation Reduction Act (IRA), which limits prescription drug spending for Medicare beneficiaries and allows Medicare to negotiate drug prices. They argued that these benefits should be extended to all Americans, not just seniors, and vowed to continue fighting to lower drug costs.

3. Call for Drug Price Reduction and Industry Response: The op-ed emphasized the urgent need to reduce drug prices, noting the potential financial burden on the American healthcare system if prices remain high. They warned of taking further action if manufacturers like Novo Nordisk do not lower prices. In response, a Novo Nordisk spokesperson criticized the op-ed for oversimplifying the issue and highlighted the value their medicines bring to patients and healthcare systems.

What Does the End of Chevron Deference Mean for the DOL?

By Paul Mulholland - The Supreme Court ruled Friday in Loper Bright Enterprises et al. v. Raimondo, Secretary of Commerce et al. that the so-called Chevron Doctrine would no longer apply to cases involving rulemakings of the federal bureaucracy, heralding what could be widespread changes to how trillions of dollars in qualified retirement plans are regulated and managed. Read Full Article…

HVBA Article Summary

1. Impact on Regulatory Stability: The Loper Bright ruling requires courts to independently assess whether federal agencies have acted within their statutory authority, rather than deferring to agency interpretations of ambiguous statutes. This shift is expected to decrease the durability and predictability of regulatory guidance, particularly affecting sectors such as qualified retirement plans, which heavily rely on consistent interpretations by bodies like the Department of Labor (DOL) and the Internal Revenue Service (IRS).

2. Challenges for Employers: Julie K. Stapel from Morgan Lewis & Bockius LLP highlights that the Loper Bright decision may lead to increased challenges for employers sponsoring employee benefit plans. The ruling could result in courts more frequently overturning DOL and IRS interpretations of regulations, such as ERISA and the Internal Revenue Code, thus introducing greater unpredictability and potential costs for employers due to the time-consuming nature of adapting to frequent regulatory changes.

3. Effect on Specific Regulations: Brian Graff, CEO of the American Retirement Association, points out that the Loper Bright ruling could significantly impact specific regulations like the Retirement Security Rule, which aims to enhance fiduciary standards for retirement saving advice. The ruling may encourage plaintiffs in ongoing court challenges to modify their complaints to leverage the new legal landscape, potentially increasing the likelihood of appellate courts vacating such rules, especially in cases where judicial leanings already favored such outcomes.

Most Americans Do Not Use Weight-Loss Drugs Long Enough to See Meaningful Weight-Loss

By BCBS - Despite the explosion in demand for weight loss drugs known as GLP-1s, 58% of patients discontinue use before reaching a clinically meaningful health benefit. This is the key finding from new research released by the Blue Cross Blue Shield Association (BCBSA) and conducted by Blue Health Intelligence® (BHI) based on data from nearly 170,000 commercial health plan members since the first FDA approval for a weight-loss GLP-1 in 2014.  Read Full Article…

HVBA Article Summary

1. High Discontinuation Rates: The study conducted by BHI revealed that a significant percentage of patients, 30%, discontinued the use of weight loss medications within the first month. This high discontinuation rate highlights the challenges patients face in adhering to these treatments and underscores the need for better patient education and support systems.

2. Impact of Provider Specialty and Frequency of Visits: According to the study, patients who received prescriptions from endocrinologists or obesity medicine specialists were more likely to persist with their treatment compared to those who received prescriptions from primary care providers. Additionally, patients who had more frequent visits with their healthcare providers, regardless of specialty, showed higher treatment persistence. This finding emphasizes the importance of specialized care and regular follow-ups in the management of weight loss medications.

3. Socioeconomic Barriers and Coexisting Conditions: The study also indicated that patients facing significant socioeconomic barriers, such as cost, transportation, and language barriers, were less likely to continue their weight loss treatment. Conversely, patients with coexisting conditions like peripheral vascular disease and diabetes, particularly those with three or more such conditions, were more likely to persist with the treatment. This data suggests that addressing socioeconomic factors and managing coexisting health conditions are crucial for improving treatment adherence and outcomes.

How LTCi protects your client’s retirement plans

By James Silbernagel - Some envision their retirement to be a slow and peaceful chapter of life, while others look forward to a full schedule of bucket list adventures or family time. Although it can be exciting to plan for this phase, it’s important to consider the challenges that can be brought by aging, including the type of care that may be needed to maintain quality of life and independence. Read Full Article…

HVBA Article Summary

1. Educating Clients on the Importance of Long-Term Care Insurance (LTCi): Financial advisors have a crucial role in helping clients understand the benefits and importance of LTCi. By addressing common misconceptions and discussing potential elder care scenarios, advisors can highlight how LTCi alleviates the financial burden of long-term care, which is not typically covered by Medicare or standard medical insurance. Asking targeted questions such as, “What is your plan for your elder care in retirement?” can open up discussions that clarify the necessity of LTCi in ensuring comprehensive retirement planning.

2. Integrating LTCi into Elder Care Strategies: Advisors should work with clients to integrate LTCi into their broader elder care and financial strategies. This involves explaining the specific benefits of LTCi, such as covering the costs of nursing homes or assisted living facilities, and comparing it to essential insurance types like homeowner’s insurance. By presenting real-life scenarios and personalized examples, advisors can demonstrate how LTCi safeguards income, assets, and health, making it an essential component of a robust financial plan for retirement.

3. Building Trust and Long-Term Client Relationships: Through thorough education and clear communication about LTCi, advisors can build stronger, trust-based relationships with their clients. Emphasizing the importance of financial literacy, advisors can prevent clients from facing regret over missed coverage opportunities. By guiding clients to make informed decisions about LTCi, advisors not only help them achieve their retirement goals but also enhance client loyalty and trust, ultimately securing long-term satisfaction and financial security for their clients and their families.

Non-Insurer Plaintiffs Join ACLI in Fiduciary Rule Lawsuit

By Paul Mulholland - The Securities Industry and Financial Markets Association and the Financial Services Institute joined a lawsuit against the Department of Labor’s Retirement Security Rule on Friday, broadening the range of firms seeking to beat back the new rule beyond just insurers—who would be hit by rules around annuity sales in particular. Read Full Article…

HVBA Article Summary

1. Legal Challenges and Initial Complaints: The Retirement Security Rule, finalized in April and set to take effect partially in September, faced its first legal challenge from the American Council of Life Insurers in the U.S. District Court for the Northern District of Texas on May 24. This followed an earlier complaint by the Federation of Americans for Consumer Choice in the U.S. District Court for the Eastern District of Texas on May 2. Both groups represent insurance industry interests and have consistently opposed the rule since its proposal.

2. Role of SIFMA and FSI in the Legal Dispute: The Securities Industry and Financial Markets Association (SIFMA) and the Financial Services Institute (FSI) joined the legal battle, arguing that the new rule is essentially the same as the 2016 version, which was vacated by the U.S. 5th Circuit Court of Appeals in 2018. They claim the rule unlawfully imposes fiduciary duties on broker-dealers and financial professionals for one-time transactions without an ongoing advisory relationship, contrary to the requirements set by the 5th Circuit.

3. Department of Labor's Defense and Rule Implementation: The Department of Labor (DOL) defends the rule, emphasizing differences from the 2016 version by focusing on the nature of the professional-investor relationship rather than specific communications or contractual terms. The DOL argues that a fiduciary relationship is established based on how professionals present themselves to investors. Despite ongoing litigation, parts of the Retirement Security Rule are still scheduled to take effect in September, with the court yet to issue a ruling on the matter.

A 5-point checklist for CAA compliance on Rx fiduciary oversight

By Greg Sanderson - As healthcare costs continue to rise, a notable shift is occurring: Employees are challenging these increases with unprecedented vigor. Armed with a growing awareness of their rights and the potential for more equitable solutions, workers are pushing back against what they see as irresponsible benefit practices. Read Full Article…

HVBA Article Summary

1. Navigating Regulatory Compliance and Cost Management: Employers are now positioned at the forefront of ensuring compliance with evolving healthcare regulations, such as the Consolidated Appropriations Act (CAA). This act emphasizes the need for cost-effective and transparent healthcare benefits. Employers must adeptly manage the interplay between adhering to regulatory standards, controlling costs, and addressing employee demands for fair pricing. This responsibility necessitates a comprehensive understanding of healthcare regulations and the ability to implement cost-management strategies effectively.

2. Optimizing Pharmacy Benefit Management (PBM) Contracts: To maintain financially sustainable and beneficial pharmacy benefit offerings, employers should reassess PBM contracts annually, ensuring they secure competitive rates that reflect current market dynamics. Working with independent partners who can negotiate favorable terms and incorporate third-party cost-containment solutions for specialty generics is crucial. Regular auditing of rebates and scrutinizing PBM formulary choices to prioritize cost-effective biosimilars without compromising quality are essential steps in optimizing PBM contracts.

3. Implementing Strategic Cost-Saving Measures: Employers should advocate for specific discount guarantees for specialty generics, separating them from specialty brands to ensure lower-cost generics' savings are effectively passed down. Formulary management, focusing on biosimilars, can significantly impact cost savings. By implementing these strategic measures and maintaining rigorous oversight, employers can protect their interests and those of their members, setting a standard for responsible and effective healthcare benefits management while staying compliant with the CAA.