Senate Bill Proposes Slashing ‘Red Tape’ Around Biosimilar Interchangeability

By Frank Vinluan - Samsung Bioepis is one of several companies angling to market a follow-on version of the blockbuster immunology drug Humira, and the company recently reported preliminary data from a study showing its product could be substituted for the AbbVie medicine. Proposed federal legislation would eliminate this requirement, which bill sponsors characterize as unnecessary and expensive. Read Full Article…

VBA Article Summary

1. Introduction and Support for the Biosimilar Red Tape Elimination Act: Senator Mike Lee of Utah has introduced legislation aiming to streamline the process of bringing biosimilars to market by removing the necessity for testing interchangeability with reference biologic products. The bill, labeled the "Biosimilar Red Tape Elimination Act", garners bipartisan support, with notable endorsements from Democratic Senator Ben Ray Lujan, along with Republicans Mike Braun and J.D. Vance. This legislation posits that the existing testing mandates contribute to inflated costs and delays in the introduction of more affordable biosimilars to the market.

2. Current Regulatory Stance on Biosimilar Interchangeability and Proposed Changes: Currently, pharmacists are restrained from substituting biosimilars for biologics unless the FDA has approved them as "interchangeable", a process requiring additional costly and time-consuming clinical studies to ascertain their safety and efficacy. Lee's bill proposes to alter this by granting biosimilars automatic interchangeable status upon FDA approval, eradicating the need for switching studies. However, the bill permits the Secretary of Health and Human Services to mandate switching studies in specific circumstances, subject to a detailed justification process involving consultations with key Senate and House committee members. Furthermore, the proposed legislation does not impede the states' authority to formulate their own policies regarding biosimilar substitutions.

3. Industry Response and Comparative International Perspectives: The international backdrop presents a mixed stance on biosimilar interchangeability, with the European Union recently harmonizing its policy to allow approved biosimilars to be interchangeable with their reference product or an equivalent biosimilar. However, the industry's reaction to Lee's bill remains somewhat muted. Major players like Samsung Bioepis withhold their stance on the bill, emphasizing the FDA's role in fostering an understanding of interchangeability among healthcare professionals. Moreover, prominent industry groups, including the Biosimilars Council and PhRMA, have refrained from publicly commenting on the bill, despite their historical involvement in lobbying efforts surrounding generic and biosimilar legislations. The bill, presently designated as S. 2305, is under review by the Senate's Health, Education, Labor, and Pensions (HELP) committee.

A Huge Threat to the U.S. Budget Has Receded. And No One Is Sure Why.

By Margot Sanger-Katz and Alicia Parlapiano - For decades, runaway Medicare spending was the story of the federal budget. Now, flat Medicare spending might be a bigger one. Something strange has been happening in this giant federal program. Instead of growing and growing, as it always had before, spending per Medicare beneficiary has nearly leveled off over more than a decade. Read Full Article…

VBA Article Summary

1. Unexpected Stagnation in Medicare Spending: Over the past decade, Medicare spending per beneficiary has surprisingly leveled off, a trend contradicting the historical trend of continuously growing expenditure. This shift, significantly impacted by policy changes such as the Affordable Care Act in 2010 and budget agreements in 2011, has resulted in enormous savings for the federal budget, with experts labeling it as a pivotal occurrence in federal budget history in the last two decades. Despite the increased number of people utilizing Medicare due to the aging baby boomer population, the per-person slowdown in Medicare spending has largely curtailed the anticipated skyrocketing federal expenditure.

2. The Complex Dynamics Behind the Spending Slowdown: While certain factors contributing to the spending slowdown are apparent, like policy shifts and more efficiency in the health system, a large portion of the savings cannot be directly attributed to any clear policy changes. These reductions are categorized as "technical adjustments" by the Congressional Budget Office, encompassing changes in public health trends and medical practice adaptations. For instance, a decline in heart attacks and strokes due to widespread availability of effective medicines and a lack of new expensive medical treatments have helped keep the costs at bay. Furthermore, healthcare providers are increasingly cautious about adopting new, evidence-lacking therapies, shifting more care outside expensive hospital settings, fostering a more cost-conscious approach among healthcare professionals.

3. Potential Future Implications and Concerns: Despite the favorable budgetary impacts, the Medicare spending slowdown has also brought about some negatives, including slower improvements in senior citizens' life expectancy and restricted access to preferred treatments due to cost containment strategies. Moreover, the longevity of this trend remains a hot topic of debate among scholars, with uncertainties looming regarding potential shifts that might spike Medicare spending once again. These shifts could be triggered by various factors like new drug developments, a deviation from current cost-cutting practices, or the emergence of new chronic conditions. As Medicare continues to grow, albeit more slowly than anticipated, apprehensions persist about the possible strain on the Medicare trust fund and a surge in federal debt, putting the future of Medicare spending at the forefront of policy discussions once more.

A big win for PBMs (and self-funded health plans) in Oklahoma appeals court ruling

By Scott Woldridge - Legal analysists are calling a recent court ruling a win for pharmacy benefit managers (PBMs) and self-funded health insurance plans, with an appeals court ruling that PBM structures such as requiring the use of mail-order pharmacies cannot be restricted by state law. Read Full Article…

VBA Article Summary

1. Federal Appeals Court Ruling on PBMs and ERISA: A recent ruling by the U.S. Court of Appeals for the Tenth Circuit declared that pharmacy benefit managers (PBMs) are subject to the regulations outlined by the Employee Retirement Income Security Act of 1974 (ERISA), overriding the prior judgement by the U.S. District Court for the Western District of Oklahoma. This federal intervention stipulates a more unified approach, as opposed to state-based regulations, necessitating PBMs working with state plans to encompass both physical pharmacies and mail-order services, potentially modifying the structure of pharmacy networks for state plans and altering cost-containment strategies previously employed by PBMs.

2. Controversies and Diverging Views on the Decision: The ruling has garnered mixed reactions from various stakeholders in the pharmacy and health sectors. Many pharmacy associations, including the National Community Pharmacists Association and the Oklahoma Pharmacists Association, criticized the ruling as a deviation from previous federal court decisions, highlighting the possible adverse effects on consumers' choice and advocating for the decision to be overturned by the U.S. Supreme Court. Meanwhile, some employee benefits experts have welcomed the ruling, noting its potential to maintain current cost-saving structures and aid small businesses by fostering innovation in pharmacy benefit management.

3. Potential Implications and Future Directions: The case unveils deeper issues concerning the clash between state and federal powers in the health sector regulation, especially in the evolving landscape of healthcare delivery and management. It might initiate a reassessment of the scope and reach of ERISA in the health regulation domain, bringing forth significant discussions and potentially leading to new judicial or legislative developments. Moreover, the ruling may instigate further innovations and alternative arrangements in the pharmacy benefits sector, with employers and PBMs exploring various avenues to manage pharmacy costs efficiently while navigating the complex regulatory environment.

By PlanSource - ORLANDO, Fla., Sept. 06, 2023 (GLOBE NEWSWIRE) -- PlanSource, a leading provider of cloud-based benefits administration technology, announced today the launch of its Summer Product Release. Available August 24 to all PlanSource customers and partners, the Summer Release continues to enhance the benefits engagement product, The Source, prepare customers for Open Enrollment, and more. Read Full Article…

VBA Article Summary

1. Expansion and Optimization of The Source Platform

   PlanSource has introduced new features to enhance its benefits engagement platform, The Source, which was launched in 2022. The recent updates emphasize a seamless and personalized user experience across multiple devices, including smartphones, laptops, and tablets. Further, the platform now integrates email functionality, allowing HR leaders to disseminate important company information efficiently through The Source inbox in addition to traditional email channels. The revamped "My Company" page replaces the old "My Documents" page, offering more clarity and organized access to essential documents and links, facilitating smoother navigation and interaction for the users.

2. Enhancements in Integration and Compliance Features

   The Summer Product Release introduces several pivotal features to streamline administrative tasks and improve compliance measures. These include API transaction trackers which increase the transparency and efficiency of API transactions, Enrollment API enhancements that facilitate smoother integrations and transaction groupings based on employees, and updates to the Evidence of Insurability (EOI) procedures which make the election process quicker and more automated. Additionally, the platform aids in seamless ACA reporting by allowing custom start month selections and recognizing full-time employees working at least 130 hours per month, thus ensuring accurate 1095-C form reporting.

3. New Strategic Partnerships to Enrich Employee Experience

   PlanSource has expanded its Partner Marketplace with the addition of eight new partners specializing in different aspects of employee wellness and lifestyle benefits. These partnerships aim to cater to the evolving needs of employees and their families by offering services and solutions in areas like fertility, behavioral health, chronic disease management, caregiver support, and more. The new partnerships with organizations such as ARC Fertility, DarioHealth, Empathy, and others underline PlanSource's commitment to fostering a wholesome and supportive work environment, by integrating innovative solutions that address a wide spectrum of employee well-being aspects. Through these collaborations, PlanSource aims to enhance employee experiences and offer tailored solutions to meet the modern workforce's dynamic needs.

HHS Will Likely Face More Lawsuits Against Drug Price Negotiation Now That It Has Named the First 10 Meds Included In the Plan

By Katie Adams - Novartis became the seventh drugmaker to legally challenge the White House’s Medicare drug pricing negotiation program. The company filed its lawsuit three days after HHS announced the first 10 drugs that were selected for the program — its heart failure medication Entresto was one on the list. HHS can expect to face more lawsuits from the manufacturers of the 10 drugs it named last week, experts have warned. Read Full Article… 

VBA Article Summary

1. Widespread Legal Backlash Against Medicare Drug Pricing Program

   Lawsuit by Novartis: Last Friday, Novartis became the latest pharmaceutical company to challenge the White House's Medicare drug pricing negotiation program legally, centering on the inclusion of its heart failure medication, Entresto, on the list of 10 drugs selected for price negotiations under Medicare Part D. This move follows lawsuits from other major drugmakers including AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Johnson & Johnson, and Merck, all aiming to nullify the price negotiation program, which they allege infringes on their constitutional rights.

2. Financial and Constitutional Concerns Raised in the Lawsuits

   Allegations of Unconstitutional Taking: Novartis, like other companies that have filed lawsuits, asserts that the drug price-setting provisions introduced in the Inflation Reduction Act represent an unconstitutional taking of pharmaceutical manufacturers' private property. The provisions allegedly impose excessive fines on companies that refuse to participate in the negotiations or adhere to the stipulated "maximum fair price", thereby violating their First Amendment rights. The company's statement highlights deep-seated disagreements with the policy, warning of crippling impacts on the industry.

3. Potential Implications and Future Developments

   Projected Savings and Further Legal Actions: The Biden administration envisages an annual saving of $25 billion by 2031 through the drug price negotiation plan. Meanwhile, other manufacturers with drugs included in the HHS list, such as Amgen, Eli Lilly, Novo Nordisk, and Pfizer, are expected to initiate legal actions soon. Additionally, experts predict that these lawsuits, which are likely aimed at escalating to the Supreme Court, could potentially delay the implementation of the government's price negotiation initiative, further exacerbated as companies modify their lawsuits to underscore the financial repercussions more explicitly.

Unplug! How and why to encourage employees to take a vacation

By Bryce Sanders - In the “good old days”–let’s call that period pre-2008–the majority of commercial insurance was full-risk: increases came out of payor profitability rather than employers’ and consumers’ pockets, and patients were protected from high out-of-network/out-of-pocket costs. In 15-20 years, everything has changed. A lot. Read Full Article…

VBA Article Summary

1. Redefining Time Off as a Valuable Employee Benefit

   Historical Background: Highlight the long history of time off benefits, dating back to 1874 in the UK where companies facilitated vacations for their employees.

   Current Preferences: Mention the high regard employees have for paid time off in comparison to other benefits like health care and retirement plans.

   Company Culture Dilemma: Discuss the present scenario where some employees and managers view taking time off as a sign of lack of commitment, emphasizing the need for a shift in perspective.

2. Encouraging Employees to Utilize Paid Time Off

   Clear Policies: Advocate for well-structured and transparent time-off policies to eliminate hesitation and whisper conversations about vacation plans.

   Promotion of Longevity Benefits: Illustrate how increasing years of service can correlate with more vacation days, as supported by data from the Bureau of Labor Statistics.

   Scheduling Conversations: Encourage regular discussions about vacation planning to avoid a "use it or lose it" culture, especially towards the year-end.

3. Facilitating a Culture of Wholesome Employee Vacations

   Vacation Club Savings Accounts: Bring attention to the existence of savings plans that can help employees financially plan for their vacations.

   Cash Vacation Benefits and Corporate Travel Benefits: Explore the possibilities of offering cash benefits or corporate rates for vacations to attract and retain staff effectively.

   Sharing Vacation Experiences: Encourage employees to share their vacation stories and tips, fostering a community that values time off and can inspire others to take breaks.

Two lawsuits filed against Hub over data breach

By Judy Greenwald - Two putative class-action lawsuits were filed Friday and Monday in the same judge’s court in Chicago in connection with the cyber breach revealed by Hub International Ltd. earlier this month after a delay of several months. Read Full Article…

VBA Article Summary

1. Lawsuits Filed: Two similarly worded lawsuits, Christopher Roy v. Hub International Ltd. and Shannan Ellis vs. Hub International, have been filed in U.S. District Court in Chicago. The suits allege that the Chicago-based broker, Hub International, failed to adequately protect the personal data of approximately 479,000 individuals. The compromised data includes sensitive details such as driver's license numbers, Social Security numbers, and financial account information.

2. Breach Timeline and Company Response: Hub International publicly acknowledged a breach in its systems on Aug. 11, revealing that the unauthorized access took place between December 2022 and January 2023. They became aware of the breach on Jan. 17 and have since begun an ongoing investigation. The company announced that, in response to the breach, they have taken steps to bolster their security measures.

3. Allegations of Delay and Lack of Transparency: The Ellis lawsuit, filed on a recent Friday, claims that victims of the data breach were left uninformed for seven months post-incident. The notification, when it did arrive, allegedly lacked clarity and transparency, as it did not indicate the scale of the breach, the method of the unauthorized access, or the reasons for the extended delay in communication. Both the Roy and Ellis lawsuits accuse Hub International of negligence, unjust enrichment, and other charges. Hub International has yet to issue a comment regarding the allegations.

The Key to Employee Engagement Is Purpose. Here's Why — and How to Foster It in Your Workplace.

By Eric Watkins - Employees seem to be following a pattern of professional detachment. Since the beginning of 2020, Gallup's worker engagement polls have shown steady employee-organization distancing. In the last three years, employee engagement levels dropped four percentage points. Given it can take nearly six months to break even after hiring and onboarding new talent, leaders everywhere are contemplating strategies to bring engagement numbers up again. One solution is to focus on fostering purpose for your employees. Read Full Article… 

VBA Article Summary

1. Purpose-Driven Leadership and Structure: Employee engagement is crucial for retaining talent and fostering a healthy organizational environment. Designating roles such as a "Director of Employee Engagement and Corporate Culture" emphasizes the importance of fostering purpose. Leaders need to lead by example, establishing a trust-based environment that encourages collaboration and openness. Implementing internal positions like "Captains" ensures consistent communication and maintenance of the company's values and culture across teams.

2. Celebrating Success and Recognition: Recognizing and celebrating achievements boosts employee morale and reinforces positive behavior. Companies that actively appreciate their employees’ accomplishments, like the winners of Gallup's Exceptional Workplace Award, tend to have significantly higher engagement rates. Employing regular recognition practices, such as "forced recognition" or celebrating milestones in real-time, fosters a fun, cohesive, and encouraging company culture.

3. Beyond Monetary Compensation - The Value of Holistic Benefits: Being people-focused involves addressing the diverse needs of employees beyond just their salaries. Leading companies like Nike emphasize work-life balance, continuous education, health benefits, and fitness programs to keep their employees engaged and prevent burnout. While it might be challenging to cater to every individual need, the primary goal is to create an environment where employees feel valued and find purpose in their work. This not only enhances internal relations but also promotes business growth and stability.