US govt sets rule meant to speed up insurance approvals

By Reuters - U.S. President Joe Biden's administration on Wednesday finalized a rule requiring health insurers to set time targets for the prior authorization process for patients seeking approval for medical services under government-backed insurance. Read Full Article…

VBA Article Summary

1. Implementation of New CMS Rule: The Centers for Medicare & Medicaid Services (CMS) announced that a new rule, set to be primarily enforced starting in 2026, will mandate quicker decision times for prior authorizations by health insurance companies. This rule targets insurers offering government-backed plans like Medicare and Medicaid, aiming to streamline the process and reduce waiting times for patients needing medical procedures.

2. Streamlined Authorization and Transparency Requirements: The new CMS rule stipulates that health insurers must provide authorization decisions within 72 hours for urgent medical requests and within seven days for non-urgent requests, significantly reducing the current decision timeframe for some insurers. Additionally, insurers are now required to provide explicit reasons for denying any prior authorization request, facilitating easier re-submission or appeal by patients and healthcare providers.

3. Industry Response and Actions: The mandate has been met with varying responses from the industry, with some physician organizations advocating against prior authorizations due to the increased administrative burden and potential for restricting coverage. Major insurers like UnitedHealth Group and Cigna have proactively stated their intentions to reduce reliance on prior authorization, aligning with the broader aim of the CMS rule to expedite and demystify the medical approval process for patients.

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FDA eyes collaborative review pilot for gene therapies

By Joanne S. Eglovitch - The US Food and Drug Administration (FDA) is working on a pilot program that will explore the possibility of concurrent collaborative review of new gene therapy applications with other global regulators. Read Full Article…

VBA Article Summary

1. Introduction of the Collaboration on Gene Therapies Global Pilot (CoGenT): Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), detailed the initiation of CoGenT at the Alliance for Regenerative Medicines (ARM) meeting in San Francisco. The pilot, which aims to foster gene therapy development, will initially involve regulatory members from the International Council for Harmonisation (ICH), including the EU, US, Japan, Canada, and Switzerland. Despite being in the early development stages, Marks indicated that the pilot gained momentum due to the collaborative spirit fostered during the pandemic.

2. Goals and Procedures of CoGenT: The primary objective of the pilot is to enhance the efficiency of regulatory reviews for new gene therapy applications, thereby reducing the time and cost required for agencies and sponsors to introduce these therapies into the market. This will be achieved by enabling partners to participate in internal regulatory meetings with sponsors and sharing the reviews with regulatory partners, all under strict confidentiality agreements. Marks highlighted the commonalities between global regulators, such as the FDA and the European Medicines Agency, underscoring the potential benefits of harmonizing requirements and combining efforts to review products, particularly in the field of rare diseases.

3. Emphasis on Collaboration for Rare Disease Treatments: Marks stressed the importance of a collaborative approach in the field of rare diseases, where patient populations are limited and distributed globally. By pooling resources and patient data from different regions, such as the US, the EU, and Japan, the pilot aims to improve the viability of developing treatments for rare diseases, making it more attractive for sponsors to invest in these areas. Marks compared this approach to the collaborative review processes seen in projects like Orbis in the oncology space, advocating for a unified effort to meet the global demand for innovative gene therapies.

Driving down health cost spend in 2024 (without diminishing quality of care)

By Oliver Ayres - As business leaders begin budgeting and strategizing for 2024, many are faced with balancing two items when it comes to benefits: ensuring low costs and prioritizing employees’ requests to offer better health benefits. Read Full Article…

VBA Article Summary

1. Leverage Steerage and Incentives: Businesses can mitigate health care expenses by utilizing steerage, guiding employees to specific health care providers for cost-effective services like outpatient procedures. Incentives such as reduced out-of-pocket costs can be negotiated by partnering with high-quality, competitively-priced providers. This approach not only offers immediate cost savings but also enhances the care experience for employees, ultimately leading to a reduction in overall health care expenditures.

2. Control Pharmacy Expenditure: With pharmacy costs constituting a significant portion of health care expenses and showing an upward trend, employers need to adopt a proactive stance. Engaging in transparent discussions with brokers and scrutinizing the financial dynamics of pharmacy spend, like commissions and acquisition costs, are pivotal. By prioritizing generic medication options, seeking increased rebates, and understanding the underlying cost structure, employers can effectively rein in escalating pharmacy expenses.

3. Address Health Care Demand Through Education and Prevention: Misconceptions about overutilization of health care services are prevalent; in reality, many defer care due to cost concerns. Employers can influence demand positively by fostering a culture of health and wellness, primarily through continuous education and the promotion of healthy lifestyles. Additionally, reducing barriers to preventative care can play a crucial role. By facilitating easier access to preventive services and championing patient-centric health plans, employers can not only enhance the overall health of their workforce but also realize substantial savings in health care costs.

‘Shell game’: When private equity comes to town, hospitals can see cutbacks, closures

By Anna Claire Vollers - Peggy Malone walks the quiet halls of Crozer-Chester Medical Center, the Pennsylvania hospital where she’s worked as a registered nurse for the past 35 years, with the feeling she’s drifting through a ghost town. Read Full Article…

VBA Article Summary

1. Decline and Impact of Private Equity in Healthcare: The Crozer-Chester hospital, once a vital part of its community in Upland, Pennsylvania, faces severe cutbacks under private equity ownership. Services like the pediatric unit and detox program are eliminated, and essentials like cable in patient rooms are disconnected. Peggy Malone, a nurse at the hospital, expresses the struggles of providing quality care amidst these cutbacks. Private equity's model of buying hospitals, extracting profits, and leaving them debt-ridden and service-depleted is criticized by lawmakers and healthcare professionals alike, leading to a bipartisan congressional investigation.

2. Varied State Responses and Regulatory Challenges: The ownership of Crozer-Chester by Prospect Medical Holdings, backed by private equity firm Leonard Green & Partners, led to massive debts and service reductions, affecting vulnerable communities. Different states respond variably, with Rhode Island showcasing robust regulation that somewhat mitigated the negative impacts, highlighting the importance of aggressive state laws and enforcement in protecting communities. In contrast, less stringent regulations in Pennsylvania and Connecticut allowed the decline of hospital services and community health resources, prompting calls for legislative reform.

3. Legislative Efforts and the Future of Hospital Ownership: In response to the challenges posed by private equity in healthcare, states are considering new legislation to increase oversight and protect communities. Measures include requiring detailed reporting of significant transactions, granting the attorney general's office power to challenge harmful deals, and enhancing state review processes. These efforts are part of a broader recognition of the need to scrutinize private equity's role in healthcare, with the aim of preserving hospital services and ensuring that healthcare institutions serve the public interest.

CMS finalizes prior auth rule with added payer requirements

By Jasmyne Ray - [Wednesday] CMS finalized the Interoperability and Prior Authorization Final Rule, continuing its efforts to improve prior authorization processes. Read Full Article…

VBA Article Summary

1. Introduction of New Requirements: The new rule introduces stringent requirements for Medicare Advantage, CHIP, and Medicaid managed care plans as part of the MA and Part D final rule. It aims to streamline the prior authorization process, a major issue for health organizations, as evidenced by the investments in various revenue technology solutions to mitigate related challenges. Shanda Richards, the revenue cycle director at Central Peninsula Hospital, emphasized the urgency of the situation, highlighting the delays in care due to protracted prior authorization processes.

2. Expected Benefits and Implementation Timeline: The U.S. Department of Health and Human Services anticipates the rule will yield substantial financial savings, estimating around $15 billion over the next decade. From 2026, the rule mandates that payers involved must process expedited prior authorization requests within 72 hours and standard requests within a week. Moreover, it requires these payers to explicitly state the reasons for any denials of prior authorization and mandates the public disclosure of prior authorization metrics.

3. Support and Criticism of the Rule: The rule has garnered support from various stakeholders, including Anders Gilberg of the Medical Group Management Association, who praised the rule's increased transparency provisions. These provisions demand health plans to elucidate the reasons behind care denials and annually publish comprehensive metrics about their prior authorization programs. Gilberg argues that this transparency will expose and curb the misuse of prior authorization by payers, who ostensibly use it to protect patient interests.

United States of Ozempic: Where anti-obesity drugs are taking off

By Tina Reed - For every 1,000 people in Kentucky, roughly 21 were prescribed a drug that belongs to a buzzy class of diabetes and anti-obesity medications last year — the highest rate of any state, according to insurance claims data provided to Axios by health analytics company PurpleLab. Read Full Article…

VBA Article Summary

1. High Prescribing Rates in Southern States: Southern states like Kentucky, Louisiana, and Mississippi are leading in the prescribing rates for GLP-1 agonists, drugs like Ozempic and Wegovy, which are crucial in combating obesity and diabetes. Kentucky tops the list with the highest rate, followed closely by West Virginia, Alaska, Mississippi, and Louisiana. In contrast, states like Rhode Island, Massachusetts, Wisconsin, and Hawai'i have the lowest prescribing rates.

2. Demographic and Disease Prevalence Correlation: The high prescribing rates in these states align with the prevalence of obesity and diabetes, as indicated by CDC data. This suggests that GLP-1 agonists are reaching areas with the most pressing need for these treatments. However, accessibility is hampered by factors like shortages, high costs, and insurance limitations. The analysis is based on a substantial dataset of 1.9 billion claims from private insurers, Medicare, and Medicaid, covering medications such as Ozempic, Wegovy, Mounjaro, and Zepbound.

3. Data Insights and Limitations: The aggregated nature of the data prevents a detailed understanding of the specific use of these medications for obesity or diabetes treatment and the duration for which patients remain on these drugs. Notably, a significant proportion of patients discontinue these medications within a year of starting them for weight loss. The data also doesn't account for prescriptions paid for in cash, which is a notable gap given the high out-of-pocket cost of these drugs, ranging from $900 to $1,300 per month.

Cyber attacks are one of the biggest threats facing healthcare systems

By Nick Huber - An increase in cyber attacks on the healthcare sector is jeopardising patient safety, and prompting some governments to publish new cyber security standards. Read Full Article…

VBA Article Summary

1. Cybersecurity Threats in the Healthcare Sector: The article highlights the alarming rise in cyber-attacks on the healthcare sector, with healthcare suffering more attacks than any other sector. These include various types of breaches such as hacking, supply chain attacks, phishing, and ransomware, causing significant disruptions like the cancellation of patient appointments and the compromise of confidential records. Notable incidents include the "WannaCry" attack on the UK's National Health Service and breaches in hospitals across Germany, the US, and Finland. The prevalence of legacy IT systems in healthcare, which often remain outdated and vulnerable, exacerbates the risk of such attacks.

2. Response and Preventative Measures: Healthcare executives acknowledge cyber risk as a top concern, prompting the adoption of various defensive strategies. These include annual cyber security audits, adopting a "zero trust" approach, and employing antivirus and intrusion detection software. Moreover, advanced tools like Extended Detection and Response (XDR) and specialized software for securing medical hardware are gaining traction. Despite these efforts, the sector's heavy reliance on increasingly interconnected medical devices presents ongoing challenges, necessitating continued vigilance and innovation in cybersecurity measures.

3. Government Initiatives and Future Outlook: Recognizing the critical nature of cybersecurity in healthcare, governments in the US and UK are taking action. Strategies include setting minimum standards for hospital cyber security, offering government funding for security enhancements, and mandating harsher penalties for non-compliance. While these efforts, alongside international collaboration and technological advancements, contribute to fortifying the sector's defenses, experts caution that the battle against cyber threats is dynamic. As attackers continually refine their tactics, the healthcare sector must stay ahead by constantly evolving its cybersecurity strategies, essentially engaging in an ongoing cat-and-mouse game.

Cancer death rate continues to decline but new cases expected to top 2 million this year, study finds

By Heather Landi - Cancer deaths in the United States are falling, with more than 4 million fewer deaths since 1991. The mortality rate has dropped as a result of less smoking, earlier detection for some cancers and improved treatment, according to Rebecca Siegel, senior scientific director, surveillance research at the American Cancer Society and lead author of ACS's new annual report. Read Full Article…

VBA Article Summary

1. Rising Cancer Incidences and Shifts in Demographics: The American Cancer Society (ACS) reports a troubling increase in cancer diagnoses, surpassing 2 million new cases in 2024 in the U.S., with notable rises in common cancers such as breast, prostate, and endometrial, alongside a shift in colorectal cancer becoming the leading cause of cancer death in younger adults. The data reveal a younger demographic of cancer patients, with a growing proportion of diagnoses among middle-aged individuals (50-64 years), potentially linked to lifestyle factors like obesity and other yet unidentified elements.

2. Alarming Trends in Specific Cancers and Need for Action: The report highlights concerning trends, such as the sharp increase in colorectal cancer in younger Americans and the continuous rise in uterine corpus (endometrial) cancer mortality rates, particularly affecting women of color. It emphasizes the urgency of enhancing screening programs, increasing vaccine uptake (e.g., HPV for cervical cancer prevention), and understanding the underlying causes of these trends to develop effective prevention strategies.

3. Persistent Disparities and the Call for Policy Interventions: Despite some progress, the report underscores persistent cancer disparities, with significantly higher mortality rates observed in Black and Native American populations for certain cancer types. The ACS advocates for robust public policy interventions to mitigate these disparities, emphasizing the importance of health insurance coverage, access to quality care, and increased funding for cancer research and screening programs as pivotal steps toward reducing cancer incidences and achieving equitable health outcomes.

Employers are struggling to figure out if they're overpaying for health care

By Tina Reed - Employers are facing stronger legal requirements to ensure they aren't wasting their workers' money on overpriced health insurance, at the growing risk of financial consequences. Read Full Article…

VBA Article Summary

1. Challenges in Health Care Price Transparency for Employers: Employers are grappling with the lack of transparency in health care pricing, which hampers their ability to determine if they are paying fair prices for employee health plans. Despite federal fiduciary requirements mandating employers to ensure their contracts don't contain "gag clauses" that restrict access to pricing data, many find it challenging to comply. Employers and their plan administrators often face a lack of cooperation, with instances of unidentified gag clauses in contracts hindering the process. This obscurity not only affects the employers' capacity to negotiate better deals but also impacts employees, as rising premiums continue to outpace wages, eating into their potential earnings.

2. Legislative Efforts and Lobbying for Greater Transparency: In response to these challenges, employer groups are actively lobbying for transparency legislation, with proposals in both the House and Senate aimed at increasing visibility into health care prices. The proposed bills seek to make pricing information more accessible by requiring hospitals, labs, and other providers to publicly post negotiated prices and by obliging insurers to provide detailed reports on spending and fees. The more ambitious Senate version pushes for daily feeds of insurance claims and services, along with a mandate for providers and insurers to ensure the accuracy of the disclosed prices. These legislative efforts signify a collective push towards demystifying health care costs and enabling employers to be more effective stewards of their employees' health benefits.

3. Implications and Future Outlook: The quest for transparency in health care pricing is setting the stage for significant shifts in how employers manage health benefits and negotiate with providers. The industry is watching closely as legal strategies evolve, with law firms reportedly considering class action suits against companies over their health plan management, akin to cases seen in the management of 401(k) plans. This legal scrutiny, combined with the growing access to claims data, is prompting a reassessment of fiduciary responsibilities and accountability in the health care sector. As debates continue and legislative proposals are deliberated, the outcome will likely reshape the dynamics between employers, insurance providers, and the broader health care system, ultimately aiming to create a more transparent and equitable framework for managing health care costs.