Legalized Racketeering? How PBMs Skirt the Law to Rake in Billions

By Rachel Madley - Pharmacy Benefit Managers (PBMs) have been under scrutiny lately for their actions as middlemen in the flow of prescription drugs from manufacturers to patients. Read Full Article…

HVBA Article Summary

1. Consolidation of Power: Big Insurance has consolidated the pharmaceutical benefit management (PBM), claims, and dispensing sectors to maximize profits at the expense of patients, creating a complex web that obscures actual drug costs and disguises profit margins as medical claims.

2. Manipulation of Pricing: Through examples like Aetna and CVS Health, the article highlights how PBMs manipulate drug prices. For instance, a patient pays $17,710.21 for a chemotherapy drug that costs less than $70 to acquire. This allows insurers to report inflated medical claims costs while hiding significant profits.

3. Regulatory Evasion: Big Insurance exploits loopholes in regulations like the medical loss ratio (MLR), allowing them to classify inflated profits as medical claims costs when PBMs own pharmacies. This not only reduces the funds available for patient care but also leads to higher out-of-pocket costs for patients.

Most Healthcare Organizations Have Paid $500K or More in Ransom Post-Cyberattack, Report Says

By Katie Adams - More than a quarter of organizations have suffered a financial loss of $1 million or more due to cyberattacks, according to research released this week by cybersecurity company Claroty. Read Full Article…

HVBA Article Summary

1. Vulnerability and Financial Impact: The healthcare industry is highly susceptible to cyberattacks, with over 75% of organizations reporting ransom payments exceeding $500,000. Ransomware attacks not only lead to financial losses due to the ransom itself but also incur significant costs related to operational downtime, recovery efforts, and potential legal fees.

2. Complexity of Security Management: The increasing complexity of hospital networks, which now include various IT and medical devices, complicates cybersecurity efforts. Challenges include securing medical devices and managing diverse third-party connections, which can lead to supply chain vulnerabilities.

3. Improvements and Ongoing Challenges: While healthcare organizations have made progress in enhancing their cybersecurity measures by adopting risk reduction strategies and improving asset visibility, they still face hurdles in understanding and managing third-party risks. Ongoing investments in vulnerability management and alignment with HHS cybersecurity guidelines are essential for improving overall security posture.

When AI Technology and HIPAA Collide

By Todd Mayover - HIPAA Covered Entities beware! Your vendors are probably implementing artificial intelligence (“AI”) technology within their service offerings. Today, an all-too-common scenario involves an email message or telephone call from your trusted third-party vendor indicating that they are going to integrate AI technology into their service offerings that will involve the use of your patients’ Protected Health Information (PHI). Read Full Article…

HVBA Article Summary

1. Benefits vs. Risks of AI in Healthcare: While AI technology promises faster deliverables and improved medical insights, it also presents significant risks related to the use of Protected Health Information (PHI), particularly in terms of HIPAA compliance. Covered Entities and their Business Associates must carefully evaluate how AI systems use PHI to mitigate potential negative impacts on vendors and patients.

2. HIPAA Compliance Challenges: The application of HIPAA rules is crucial when utilizing PHI in AI technology. Covered Entities must ensure they have appropriate authorizations for the use of PHI, minimize data usage to what is necessary, and implement strict role-based access controls. Challenges arise in balancing data requirements for AI training with HIPAA's restrictions on access and use.

3. Practical Steps for Compliance: To minimize HIPAA non-compliance risks, Covered Entities and Business Associates should develop specific policies addressing AI technology, establish an AI governance team, update contracts, provide training on PHI use, conduct regular risk assessments, and seek expert guidance on data privacy. These measures will help ensure the integrity and confidentiality of PHI in AI applications while reaping the benefits of advanced technology in healthcare.

Big Pharma, PBMs sued by Texas attorney general over 'insulin pricing scheme'

By Lynn Cavanaugh - Following the Federal Trade Commission's complaint against pharmacy benefit managers (PBMs) over the price of insulin two few weeks ago, Texas Attorney General Ken Paxton announced on Thursday that it the latest state to sue PBMs, as well as the largest insulin manufacturers over a "conspiracy" to increase the cost of insulin. Read Full Article…  ^{_{(Subscription required)}}

HVBA Article Summary

1. Lawsuit Against Major Drug Manufacturers and PBMs: Texas Attorney General Ken Paxton has filed a lawsuit against insulin manufacturers Eli Lilly, Novo Nordisk, and Sanofi, as well as pharmacy benefit managers (PBMs) Optum Rx, Express Scripts, and CVS Caremark, accusing them of colluding to artificially inflate insulin prices while benefiting from undisclosed financial agreements.

2. Allegations of Price Manipulation: The lawsuit claims that the drug manufacturers have increased insulin prices by up to 1,000% over the past decade, with current prices ranging from $300 to $700, despite production costs being less than $2. The complaint asserts that this "insulin pricing scheme" violates the Texas Deceptive Trade Practices Act and constitutes unjust enrichment and unlawful civil conspiracy.

3. Impact on Diabetic Patients: The complaint highlights that Texas diabetics, especially those aged 65 and older, have suffered significant financial harm due to the alleged actions of the manufacturers and PBMs, contradicting the PBMs' claims of working to lower drug prices and improve access to diabetes treatments.

US Medicare issues updated rules for second round of drug negotiations

By Ahmed Aboulenein - The U.S. government will provide more time for negotiations and more chances for drugmakers to submit counter offers during the second round of talks over price cuts for its Medicare program, it said on Wednesday. Read Full Article… 

HVBA Article Summary

1. Impact on Prescription Costs: The selection of the costliest prescription medications for negotiation by CMS is expected to significantly lower out-of-pocket costs for millions of Medicare beneficiaries, potentially saving them billions in healthcare expenses starting in 2027.

2. Enhanced Negotiation Process: The revised negotiation framework allows for more proactive engagement between CMS and pharmaceutical manufacturers, enabling earlier discussions and additional counteroffer opportunities. This shift aims to create a more collaborative environment that could lead to fairer pricing for consumers.

3. Timely Implementation: With the timeline for negotiations shortened, CMS is poised to finalize prices for the selected drugs by November 2025, expediting the process for implementing cost reductions. This swift action underscores the agency's commitment to improving access to affordable medications for older Americans and those with disabilities.

Tirzepatide Shortage Resolved? FDA Says Yes, Compounders No

By Marilynn Larkin - On October 2, the US Food and Drug Administration (FDA)'s Drug Shortage Database showed that the tirzepatide injection (Zepbound, Mounjaro/Lilly) shortage is now "resolved." Read Full Article…

HVBA Article Summary

1. FDA Clarification on Supply: The FDA clarified that Eli Lilly can meet both current and projected national demand for certain drugs, restricting compounders from producing their own versions, despite potential intermittent supply disruptions during distribution.

2. Challenges in Accessing FDA-Approved Drugs: The Alliance for Pharmacy Compounding (APC) emphasized the ongoing difficulties faced by pharmacies in obtaining sufficient quantities of FDA-approved drugs, with reports of limited supplies resulting in patient waitlists, thus potentially exacerbating access issues.

3. Patient Transition to FDA-Approved Medications: Healthcare professionals express concern that patients currently relying on compounded medications may struggle with sudden changes in their prescriptions. Although there is hope for improved access through FDA-approved versions, the transition could lead to additional shortages and complications for patients awaiting new prescriptions.

‘Find the broken part and fix it’: Treating depression can improve chronic pain

By Rob Volansky - Improving depressive symptoms can reduce patients’ chronic pain, according to a presenter at the 2024 Congress of Clinical Rheumatology West. Read Full Article…

HVBA Article Summary

1. Interconnectedness of Pain and Depression: Michael R. Clark, MD, emphasizes that chronic pain and depression often co-occur, but they are not always the same condition. Patients frequently seek a singular solution for their overlapping issues, which can lead to a cycle of frustration and ineffective treatments.

2. Holistic Management Approach: Rather than searching for a "holy grail" treatment, rheumatologists should adopt a comprehensive approach by addressing the various disease processes, behaviors, and life stressors that contribute to a patient's condition. This includes evaluating and adjusting ineffective medications, promoting activity, and fostering strong patient-provider relationships.

3. Depression as a Predictor of Chronic Pain: Clark highlights that depression is a significant predictor of chronic pain persistence over time. By prioritizing the treatment of depression, healthcare providers may also improve patients’ pain management and overall well-being, emphasizing the importance of achieving remission in depressive symptoms.