19 Senators Urge HHS to Drop Appeal That Would Jeopardize Americans’ Access to Life-Saving Drugs

By Katie Adams - A bipartisan group of 19 U.S. senators sent a letter to HHS asking it to rethink its appeal of a recent federal district court decision that limits the use of “copay accumulators.” Read Full Article…

VBA Article Summary

1. Copay Accumulator Programs: Copay accumulators are used by health plans to prevent copay assistance from pharmaceutical companies from reducing patients' deductibles or out-of-pocket maximums. Usually, such assistance helps lower patients' costs, but with copay accumulators, this assistance does not count towards the patient's out-of-pocket limits.

2. Legal and Policy Changes: In September, U.S. District Court Judge John D. Bates overturned a 2021 rule allowing unrestricted use of copay accumulators. This decision, resulting from patient advocacy group challenges, limits the use of copay accumulators to brand-name medications with generic equivalents. However, HHS and CMS appealed this decision, and senators urged HHS to drop the appeal to ensure cost-sharing protections for Americans with expensive medications.

3. Impact and Reactions: Studies show that reduced cost-sharing improves medication adherence, which can lower the risk of adverse events and associated costs. Despite this, health plans have increased the use of copay accumulators, often as a cost-control measure. This has led to financial hardship for patients, with some discontinuing their medication due to high costs. Blue Cross Blue Shield Association responded to these concerns, emphasizing the need for measures to address high drug prices while ensuring affordable care.

The MHPAEA Proposed Rule: Scalability and the Plight of the Small(er) Self-Funded Plan

By Alden Bianchi - After a brief hiatus to discuss the pleading standards adopted by the US Court of Appeals for the Tenth Circuit in E.W. v. Health Net Life Insurance Company, we return to our examination of the comments submitted in response to the proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA). Read Full Article…

VBA Article Summary

1. MHPAEA Regulations and Self-Funded Plans: The Mental Health Parity and Addiction Equity Act (MHPAEA) primarily governs group health plans and health insurance issuers, with a different compliance requirement for self-funded plans. Unlike fully insured plans where issuers ensure compliance, self-funded plans, often managed by third-party administrators, bear the sole responsibility for compliance. This disparity is significant, especially for small and medium-sized plans, which lack the bargaining power to modify their health plan designs, including mental health benefits, leaving them dependent on their service providers.

2. Compliance Challenges and Safe Harbor Request: The National Association of Benefits and Insurance Professionals (NABIP) highlights the difficulties faced by smaller self-funded plans in achieving MHPAEA compliance due to limited leverage over service providers and the high cost of compliance. These challenges are exacerbated when the plan count is smaller. NABIP's comment letter to the Departments calls for a compliance safe harbor for these plans and emphasizes the need for cooperation from service providers, especially in obtaining necessary data for nonquantitative treatment limitation (NQTL) analysis.

3. Need for Updated MHPAEA Self-Compliance Tool: The NABIP criticizes the outdated "2020 MHPAEA Self-Compliance Tool," urging for an updated version to be released alongside or soon after the final rule. This tool is essential for plans to assess their compliance effectively. The letter underscores the concept of "scalability," indicating that larger plans can more easily access necessary data due to their leverage, whereas smaller plans struggle, necessitating regulatory mandates for data access and an updated compliance tool.
   

Fat Joe, Jelly Roll, Wyclef Team Up for Affordable Healthcare

By Jem Aswad - Fat Joe, Jelly Roll and Wyclef Jean will team up with Power to the Patients for an event in Washington, D.C. on January 10 at Hamilton Live to advocate for a more affordable and equitable healthcare system through price transparency. Read Full Article…

VBA Article Summary

1. Event to Highlight Healthcare Injustices: With notable government officials and Congressional leaders in attendance, a special event featuring artists including Fat Joe, Jelly Roll, and Wyclef Jean will focus on exposing the injustices in the U.S. healthcare system. This system is criticized for lacking transparency in pricing, which leads to overcharges and price gouging. Fat Joe, serving as the emcee, emphasizes the need for healthcare price transparency, stating it's a non-partisan, common-sense issue, crucial for protecting patients from excessive healthcare costs.

2. Advocacy for Price Transparency Legislation: The group Power to the Patients has been instrumental in advocating for healthcare price transparency legislation on Capitol Hill. Fat Joe has actively participated in this advocacy, meeting with Congressional leaders and the White House. The campaign highlights the failure of most hospitals to adhere to existing price transparency rules, emphasizing the need for comprehensive legislation.

3. Musicians Rallying for Change and Legislation Progress: Last year, Fat Joe, along with artists like Rick Ross, Busta Rhymes, French Montana, Method Man, and Chuck D, released a public service announcement with Power the Patients, demanding elected officials commit to healthcare price transparency. They criticized hospitals and insurance companies for obscuring actual costs with estimates or average prices, leading to a lack of competition and financial burdens on patients. This ongoing campaign has gained momentum, influencing Congress to take steps towards passing healthcare price transparency legislation.

We asked a labor lawyer what AI laws HR should look out for

By Adam DeRose - Artificial intelligence tools are flooding the HR tech space, and as some regulations begin to take shape, which could create a challenging environment when it comes to deploying the tech compliantly. Read Full Article…

VBA Article Summary

1. New York City's Local Law 144: This law, enforced since last summer in America's largest city, mandates that companies using automated recruitment tools must meet specific criteria, including conducting an annual audit (which must be public) and informing candidates about the use of these tools with an option to opt out. Natalie Pierce highlighted the possibility of other localities adopting similar regulations.

2. EEOC Guidance on Automated Technology: The Equal Employment Opportunity Commission has released guidance indicating that companies could face legal repercussions if their automated technology discriminates against protected groups in hiring, performance management, and monitoring. This guidance clarifies that blaming AI for violations of Title VII is not a valid defense.

3. Broader Regulatory Trends and State-Level Initiatives: President Biden's executive order on protecting the American public from potential risks of AI, and the California Privacy Protection Agency's draft regulation on AI, indicate a growing trend towards more stringent AI regulations. Illinois is also noted for its early leadership in personal data protection, including AI use in video interviews. HR professionals are advised to stay informed about these evolving legal landscapes and consider internal AI policies to safeguard against potential legal issues.

Many patients want more streamlined texting experience with their providers, survey finds

By Anastassia Gliadkovskaya - Nearly half of patients have missed or forgotten to pay a bill because of difficulties communicating with their providers’ offices, a recent survey found. Read Full Article…

VBA Article Summary

1. Communication Challenges and Preferences: The survey by Artera revealed significant communication issues between patients and healthcare providers. About 43% of patients experienced negative health impacts due to communication challenges, and nearly 60% would consider switching doctors over poor communication experiences. Most respondents expressed a desire for more interactive, text-based conversations with providers, as current communications are often limited to simplistic, one-word responses.

2. Text Messaging Inefficiencies and Patient Frustrations: The survey highlighted inefficiencies in text messaging between patients and providers. Two-thirds of patients encountered incomplete text interactions, and about a third did not achieve their communication goals through texting, often resorting to phone calls. Issues like error messages and lack of response were common, with 62% encountering these problems frequently. Additionally, patients reported receiving repetitive and disordered messages from multiple communication channels.

3. Recommendations for Improved Patient Engagement: Meg Aranow from Artera suggests that healthcare providers should establish a governance structure to oversee patient communications, using data-driven approaches to understand and enhance digital patient engagement. This involves analyzing the effectiveness of different communication methods and tailoring them to specific patient groups. Aranow also emphasizes the importance of real conversational messaging and maintaining a human touch in digital communications to create a more patient-centric experience.

Hospitals Finally Reached Widespread Price Transparency Compliance in 2023

By Katie Adams - Hospitals seriously improved their compliance with price transparency regulations in 2023, according to a report released [last week] by Turquoise Health. Read Full Article…

VBA Article Summary

1. Implementation of the CMS Price Transparency Rule: Since January 1, 2021, the Centers for Medicare & Medicaid Services (CMS) have required hospitals to publish detailed pricing information, including gross charges, payer-specific negotiated charges, minimum and maximum negotiated charges, and cash prices in a machine-readable format. Hospitals must also display prices for the 300 most common services in a consumer-friendly format. Despite initial struggles with compliance, a report by Turquoise, a price transparency software startup, indicates a significant improvement, with 90.7% of 6,357 analyzed hospitals posting the required data by December 15.

2. Challenges in Compliance and Recent Improvements: The complexity of healthcare billing and the structure of the U.S. healthcare system were initial barriers to compliance. Less than 6% of hospitals met the requirements in 2021 and 2022. However, by 2023, there was a notable increase in compliance, with over 80% of hospitals posting negotiated rates, BUCAH rates, imaging rates, surgery rates, and cash rates. More than half of the hospitals earned a five-star rating from Turquoise for their machine-readable files, indicating significant progress in the quality of posted information.

3. CMS Enforcement and Penalties for Noncompliance: Although the CMS rule was enforced from 2021, penalties for noncompliance began in June 2022. Initially, two Georgia hospitals were fined, followed by more penalties in April 2023. By the end of the year, 14 hospitals had been fined for not adhering to the rule. This increase in penalties indicates a more stringent approach by CMS towards enforcing compliance with the price transparency rule.

FDA probing possible weight-loss drug side effects, including suicidal thoughts

By Adriel Bettelheim - The Food and Drug Administration is examining reports of suicidal thoughts and other possible side effects linked to a class of blockbuster obesity drugs and whether it needs to take regulatory action. Read Full Article…

VBA Article Summary

1. FDA's Adverse Event Reporting Update: The U.S. Food and Drug Administration (FDA) updated its adverse event reporting system, highlighting risks associated with certain diabetes and weight loss drugs, including Wegovy, Ozempic, Mounjaro, and Zepbound. The reported risks involve suicidal ideation, alopecia (hair loss), and the inhalation of stomach contents. Although the FDA emphasizes that a direct causal relationship between these drugs and the reported side effects is not conclusively established, such reports have historically led to additional safety studies, warnings on drug labels, and other precautionary measures.

2. Pharmaceutical Companies' Response: Eli Lilly, the manufacturer of Mounjaro and Zepbound, and Novo Nordisk, the producer of Wegovy and Ozempic, have acknowledged these concerns. Both companies have stated their ongoing collaboration with the FDA to monitor the safety of their products. Novo Nordisk asserts that the known risks are already indicated in their current drug labeling.

3. Market Impact and Regulatory Scrutiny: The demand for GLP-1 agonist drugs, initially approved for diabetes but now increasingly used for weight loss, has surged. This rise in popularity raises questions about their long-term effects and efficacy in different populations. The European Medicines Agency, after conducting its inquiry, expressed the need for further clarification on the link between these drugs and self-harm thoughts. Analysts anticipate continuous FDA evaluations and potential updates to drug labels. The American Society of Anesthesiologists recommended withholding GLP-1 drugs before elective surgeries due to the risk of regurgitation and inhalation of stomach contents under anesthesia. Additionally, alopecia was observed slightly more frequently in clinical trials of Wegovy compared to a placebo, although hair loss is a known side effect of rapid weight loss.

Nearly half of every dollar spent by Medicare drug plans goes to private health insurers' pharmacy benefit managers and wholesalers

By Wendell Potter - As members of Congress get back to business after the holidays, they seem to be poised to pass legislation that would address some of the abuses of pharmacy benefit managers (PBMs), the middlemen who extract so much money from the pharmaceutical supply chain. Read Full Article…

VBA Article Summary

1. Market Dominance and Profits of PBMs: The article highlights the significant control and market dominance of Pharmacy Benefit Managers (PBMs), with three major PBMs owned by large insurance companies controlling 80% of the market. This concentration is greater than in the pharmaceutical industry. The PBMs are reportedly making substantial profits, taking a larger share of every dollar spent by Medicare Part D plans on commonly used generic medications than manufacturers, pharmacies, and wholesalers. In 2022, the three biggest PBMs made a combined profit of $27.6 billion.

2. Impact on Medicare Part D Enrollees: It is noted that PBMs, through practices like spread pricing, often lead to scenarios where Medicare Part D enrollees end up paying more for their medications than the drugs cost. Many enrollees, who are seniors or disabled and rely on fixed incomes like Social Security, are unable to afford these costs, leading to them not purchasing essential medications. Additionally, PBMs make enrollees pay varying amounts out-of-pocket before their plans cover costs, which can be significant.

3. Need for Legislative Reform: The article argues for the need for legislative intervention to address the issues with PBMs. It suggests that reducing PBM profiteering could free up billions of dollars for other essential programs like Community Health Centers. There is bipartisan agreement on the need for reform, with proposals to fund healthcare initiatives by addressing waste, fraud, and abuse in the healthcare system, making generic drugs more accessible, and holding PBMs accountable.

Mark Cuban: CEOs 'waste a sh-tload of money' on healthcare

By Molly Gamble - There are many organizations in the United States that hold themselves out as advocacy organizations for better care for patients, but is that what they are really about? Here is a quote from KFF Health News. Read Full Article…

VBA Article Summary

1. Mark Cuban's Cost-Effective Pharmacy Venture: In May 2020, Mark Cuban co-founded the Mark Cuban Cost Plus Drug Co. with Dr. Alex Oshmyansky. This online pharmacy, which started operations eight months after its founding, offers over 2,000 generic medications at significantly lower prices than typical insurance rates in the U.S. The company achieves this by applying a 15% markup on drug prices, along with fixed fees for pharmacist services and shipping.

2. Impact on Employer-Provided Health Insurance: Mr. Cuban has observed a general indifference among CEOs towards the efficiency of healthcare benefits, particularly in the context of self-insured employers. He criticizes this indifference, noting that it often leads to unnecessary spending on subpar healthcare, especially affecting the sickest and lowest-paid employees. With U.S. employers facing an 8.5% increase in healthcare costs in 2024, Cuban's remarks highlight the growing financial burden on companies and the need for more effective healthcare spending.

3. Shifting Trends in Healthcare Cost Management: Cuban's comments come at a time when employers are reevaluating their passive stance on healthcare costs. There is a growing willingness among employers to explore new cost management strategies, potentially leading to greater scrutiny of healthcare quality and outcomes. This shift is partly due to economic pressures and a changing labor market, which might compel large corporations to become more assertive in controlling healthcare costs and demanding higher quality care.

CVS Caremark to kick AbbVie's Humira off some formularies in favor of cheaper biosimilars

By Zoey Becker - This year, CVS Health plans to employ the classic "out with the old, in with the new" mantra when it comes to AbbVie’s Humira. Read Full Article…

VBA Article Summary

1. CVS Caremark's Nationwide Shift: Starting April 1, CVS Caremark will replace branded drugs with cheaper biosimilars across its major commercial formularies nationwide. This move aligns with the company’s strategy to enhance the adoption of biosimilars. The U.S. biosimilar market, as highlighted by CVS Caremark, is projected to surge from under $10 billion in 2022 to over $100 billion by 2029.

2. Economic Benefits and Partnerships: CVS Caremark aims to drive the adoption of more affordable biologic drugs, offering significant cost savings. The company anticipates more than 50% savings for its clients this year compared to 2022, when branded Humira was the sole option. Despite this shift, AbbVie, the maker of Humira, remains involved through an agreement to supply a co-branded version of Humira to CVS Health’s biosimilar business, Cordavis.

3. Drug Portfolio and Patient Options: Cordavis, a division of CVS Health launched in August, focuses on commercializing a range of biosimilars, including Sandoz’s Humira copycat, Hyrimoz. This drug will be marketed at a price over 80% lower than Humira’s list price. While branded and unbranded versions of Humira from various manufacturers will be available on CVS formularies, patients on certain commercial plans will still have access to the original Humira, with a 60-day notice and no need for new authorization for the transition.