5 FDA decisions to watch in the third quarter

By BioPharma Dive staff - Two of last year’s largest biotechnology company acquisitions centered on a new type of treatment for schizophrenia. By the end of September, the first of those therapies could win Food and Drug Administration approval, a decision that would highlight the new attention being paid to psychiatric drugs. Read Full Article…

HVBA Article Summary

1. MDMA and Psilocybin Testing and FDA Decision: Psychedelics like MDMA and psilocybin are undergoing testing for their potential in psychiatric treatments. The FDA faces a challenging decision, particularly after a panel of its advisers recently criticized the use of MDMA-assisted psychotherapy for post-traumatic stress disorder. This criticism raises questions about the future approval and integration of these novel treatments into mainstream psychiatry.

2. Gilead Sciences’ Potential Drug Approval: Gilead Sciences is awaiting FDA approval for a drug acquired through its deal with CymaBay Therapeutics. This new drug, along with a novel cell therapy, could soon reach the market. Such developments indicate significant advancements in the treatment options available for various conditions, reflecting the dynamic nature of pharmaceutical innovation.

3. Upcoming FDA Decisions on New Psychiatric and Therapeutic Drugs: The third quarter is critical for several anticipated FDA decisions, including Bristol Myers’ Kar-XT for schizophrenia, Lykos’ MDMA-based therapy for PTSD, Gilead’s seladelpar for primary biliary cholangitis, Ascendis’ TransCon PTH for hypoparathyroidism, and Adaptimmune’s afami-cel for synovial sarcoma. These decisions could introduce groundbreaking treatments, addressing unmet needs in mental health and chronic diseases, and potentially transforming patient care outcomes.

Supreme Court Ruling Could Have a Big Impact on Healthcare Regulations and Legislation

By SIIA - On June 28th, the Supreme Court – in a 6 to 3 ruling – overturned the “Chevron Deference Doctrine.” As we have reported, the Chevron Deference Doctrine is a 40-year-old judicial precedent directing courts to defer to a Federal Department’s interpretation of a statute when the Department develops implementing regulations. Read Full Article…

HVBA Article Summary

1. Impact on Existing and Future Regulations: The Supreme Court's ruling to invalidate the Chevron Deference Doctrine has prompted policymakers to seek clarification on its implications. For instance, Senator Cassidy has inquired how this decision might affect the enforcement and creation of regulations under the Federal surprise billing laws. This could lead to an increase in lawsuits from healthcare providers challenging the Federal Independent Dispute Resolution (IDR) process and the Qualifying Payment Amount (QPA).

2. Legal Challenges to Proposed Regulations: The dismantling of the Chevron Deference Doctrine raises questions about the future of proposed regulations, such as those under the Mental Health Parity and Addiction Equity Act (MHPAEA). Payers argue that the new requirements and tests are inconsistent with legislative intent, making these regulations vulnerable to legal challenges. Additionally, long-opposed regulations like the Transparency in Coverage Rule may face renewed opposition and potential lawsuits from the insurance industry.

3. Legislative and Regulatory Uncertainty: The ruling will significantly impact how Congress drafts legislation, requiring more precise and comprehensive statutory guidelines. Any regulations from future administrations will face heightened scrutiny and challenges. This shift places increased responsibility on Congress to clearly define regulatory processes, as federal departments will no longer have the flexibility to interpret statutes broadly.

Federal court stalls FTC's noncompete ban

By Alan Condon - A federal court in Texas has approved a preliminary injunction against the Federal Trade Commission's sweeping noncompete ban, which, if implemented, would have seismic effects on the healthcare industry and the U.S. economy more broadly. Read Full Article…

HVBA Article Summary

1. Preliminary Injunction Issued: U.S. District Judge Ada Brown has issued a preliminary injunction preventing the FTC's rule from taking effect on September 4. This decision follows arguments from tax preparation company Ryan LLC and the U.S. Chamber of Commerce, who contend that the FTC lacks the authority to define and implement rules on unfair methods of competition.

2. Plaintiffs Likely to Succeed: In her July 3 ruling, Judge Brown stated that the plaintiffs are likely to succeed on the merits, asserting that the FTC lacks the statutory authority to promulgate the noncompete rule, which she characterized as "arbitrary and capricious." The court will make a final decision on the matter by August 30, with indications that the ban may be struck down.

3. FTC's Stance and Industry Opposition: Despite opposition from entities like the American Hospital Association (AHA), which argues that the FTC's rule overreaches its jurisdiction, especially concerning tax-exempt nonprofit hospitals, the FTC maintains its position. Douglas Farrar, director of the FTC's office of public affairs, reaffirmed the commission's authority to issue the rule and emphasized their commitment to combating noncompetes that stifle innovation and economic liberty.

CMS spells out how states can join new cell and gene therapy access pilot

By Zachary Brennan - The Centers for Medicare and Medicaid Services plans to begin testing whether outcomes-based agreements might improve access to two new gene therapies approved for sickle cell disease. Read Full Article…

HVBA Article Summary

1. Pilot Program Launch: The Cell and Gene Therapy Access Model, set to run from 2025 to 2035, will focus on negotiating outcomes-based agreements for high-cost gene therapies, starting with Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy and bluebird bio’s Lyfgenia. The model aims to enable states to better manage these agreements, potentially expanding access to treatments that would otherwise be unaffordable.

2. Fertility Preservation Requirement: As part of the program, CMS mandates that biopharma companies must cover the cost of fertility preservation services for beneficiaries undergoing gene therapy treatments. This requirement aims to assess whether manufacturer-funded fertility services can improve health outcomes and inform future Medicaid coverage decisions for fertility preservation related to gene therapies.

3. Centralized Data Collection and Monitoring: To address challenges states face with outcomes-based models, including negotiation complexity and data management, CMS will take a central role in data collection and monitoring. This support is intended to streamline the adoption of outcomes-based agreements and ensure their effective implementation, thereby maximizing access to transformative therapies for Medicaid beneficiaries.

Supreme Court Ruling Overturning Chevron Could 'Paralyze' Health Policy Making: Experts

By Alicia Ault - Experts say the US Supreme Court's ruling Friday to overturn the decades-old "Chevron doctrine" could severely restrict the ability of federal agencies to regulate all aspects of health care. Read Full Article…

HVBA Article Summary

1. Impact on Health Care Policy and Regulation: Larry Levitt of the Kaiser Family Foundation expressed concern that the ruling reversing the Chevron doctrine will hinder policymaking in health care, as Congress will need to fill in more details, complicating the legislative process. Additionally, federal agencies may become more cautious in exercising their regulatory authority, leading to potential disruptions in healthcare policy implementation.

2. Legal and Judicial Ramifications: The Supreme Court's decision to overturn the Chevron doctrine means that courts no longer have to defer to federal agency interpretations of laws, requiring them instead to use independent judgment to determine if agencies have acted within their statutory authority. This shift, highlighted in Chief Justice John Roberts’ majority opinion, signals a significant change in the balance of power between the judiciary and federal agencies, which may result in increased legal challenges and uncertainties in administrative law.

3. Reactions and Predictions: The decision has sparked varied reactions, with some members of Congress supporting the move as a return to constitutional principles, while others, like Senate Majority Leader Chuck Schumer, criticize it as a victory for special interests. Health organizations and experts predict significant disruptions in publicly funded health insurance programs and regulatory systems, potentially affecting patient and consumer protections. The ruling could invite a surge in legal challenges to agency determinations, creating a more complex and contentious regulatory landscape.

How pet bereavement leave enhances well-being and productivity

By Erika Sinner - Organizations stand to gain significantly from compassionate policies like pet bereavement leave. Before dismissing this as merely a "nice to have" or rolling your eyes, consider the profound impact it can have. Read Full Article…

HVBA Article Summary

1. Compassionate Policies: Implementing pet bereavement leave is a proactive way for companies to address productivity losses while showing employees that their personal well-being is recognized and valued. This type of policy not only boosts morale and retention but also signals that the company genuinely cares about its workforce beyond their professional roles.

2. Workload Prioritization: In cases where granting full days off for pet bereavement might be challenging, companies can offer managerial training to support leaders in helping their teams prioritize tasks effectively. This strategy ensures that employees can adjust to their loss without compromising the quality of their work, maintaining overall productivity.

3. Communication and Normalization: Promoting open communication about personal needs and deadlines, and fostering a culture where it is normal to acknowledge and support colleagues during tough times, is essential. This approach enhances team dynamics, improves the workplace atmosphere, and contributes to a supportive environment that helps employees feel valued and understood.

Medicare home health payments to dip 1.7% in CY 2025

By Jacqueline LaPointe - Home health agencies are slated to see a major dip in Medicare reimbursements next year as CMS proposes a decrease in rates to account for changes from the Patient-Driven Groupings Model (PDGM). Read Full Article…

HVBA Article Summary

1. Medicare Reimbursement Reduction: The new proposed rule from CMS estimates a 1.7% decrease in Medicare reimbursement for home health agencies in CY 2025, resulting in a $280 million reduction. This decrease is due to a proposed home health payment update of 2.5%, offset by a permanent prospective adjustment related to PDGM and other policies.

2. Case-Mix Weights and LUPA Adjustments: The rule proposes recalibrating the case-mix weights and LUPA thresholds for over 400 payment groups using CY 2023 data. Additionally, it introduces an occupational therapy-specific LUPA add-on factor, replacing the temporary use of the physical therapy LUPA add-on factor.

3. Home Health Quality Reporting Program Updates: The proposed rule includes updates to the Home Health Quality Reporting Program, with the addition of four new standardized patient assessment data elements in the social determinants of health category. It also proposes changes to Home Health Conditions of Participation to minimize avoidable care delays and require agencies to provide accurate public information on their services and limitations.

Despite adoption hurdles, healthcare is all-in on Generative AI

By David Talby - Generative AI (GenAI) is having a renaissance, but few industries are experiencing this like healthcare. As early adopters, everything from hospital operations and administrative duties, to clinical trials and drug discovery are being impacted by the technology. Despite the rosy outlook,  it doesn’t paint the full picture of GenAI in healthcare. The 2024 Generative AI in Healthcare Survey, however, does a better job at that. Read Full Article…

HVBA Article Summary

1. GenAI budgets are growing exponentially: Adoption of GenAI varies significantly across roles and company sizes. Technical leaders are at the forefront, demonstrating higher adoption rates and driving budget increases. While 34% of all respondents reported a 10-50% budget increase for GenAI, 22% witnessed a 50-100% rise. Among technical leaders, nearly one-fifth reported a staggering 300% budget growth, underscoring their advocacy and investment in GenAI. Large companies, with their abundant resources, are leading the charge in evaluating GenAI use cases. Medium-sized companies are actively experimenting with and developing AI models, while small companies, often constrained by resources, show the highest percentage not actively considering GenAI.

2. Task-specific language models reign supreme: The healthcare sector’s unique needs are driving a preference for custom-built, task-specific language models. Healthcare-specific small models are utilized by 36% of respondents, reflecting a clear trend towards targeted solutions over general-purpose large language models (LLMs). This is not surprising given the high stakes of real patient outcomes, the sensitive nature of healthcare data, and a host of regulatory standards to adhere to. What was interesting was technical leaders showing broader interest in all types of language models, indicating a willingness to explore various options. For those getting started on their GenAI journey, it makes sense to focus on healthcare-specific models, while practitioners with more experience test out other methods.

3. Use cases vary by technical experience and company size: GenAI’s applications in healthcare are diverse, with the most common uses being answering patient questions (21%), medical chatbots (20%), and information extraction/data abstraction (19%). Technical leaders, on the other hand, prioritize information extraction and biomedical research, indicating a strategic focus on gleaning data-driven insights and advancements. Respondents foresee GenAI having the most significant impact on transcribing doctor-patient conversations, medical chatbots, and answering patient questions over the next few years. Smaller companies, in particular, have high expectations for these technologies, likely due to their agility and drive to gain a competitive edge.

Where the GLP-1 weight loss market goes will depend on data

By Amy Baxter - GLP-1 drugs have taken the cardiometabolic space by storm. While the popularity of the anti-obesity drugs have created ongoing shortages and increased drugmakers’ investments in R&D, it’s not yet clear how high the market could go in the coming years. Read Full Article…

HVBA Article Summary

1. Market Potential and Challenges:

   • Analysts predict the GLP-1 market could exceed $100 billion to $200 billion by 2030.

   • A lack of long-term weight loss data may influence future consumer use and disease treatment applications.

   • Bill Coyle from ZS emphasizes the potential for significant long-term health benefits if sustained weight loss is achieved, suggesting the current stage is just the beginning for GLP-1s.

2. Expanding Clinical Applications:

   • Initially approved for diabetes and weight loss, GLP-1s are finding new applications in treating conditions like MASH, kidney disease, cardiovascular disease, and addictions.

   • Coyle suggests that if GLP-1s can demonstrate sustained weight loss, they will become highly favorable for payers.

   • The potential growth of GLP-1s in the cardiovascular market is compared to the success of SGLT2 inhibitors, which improved cardiovascular health beyond their initial use for Type 2 diabetes.

3. Impact on Cardiovascular Treatments:

   • With heart disease as the leading cause of death in the U.S., GLP-1s could become a significant part of the cardiovascular drug market, although they are not a complete solution.

   • Existing drugs like statins and ACE inhibitors help manage cholesterol and blood pressure, but GLP-1s could address obesity-related risk factors earlier in a patient’s journey.

   • More long-term data on GLP-1s and their impact on weight loss could lead to increased insurance coverage, a challenge highlighted by a survey showing only 27% of employers currently cover GLP-1s for weight loss.