HIPAA Not ‘Strong Enough’ for Health Care’s Cybersecurity Needs

By Jule Pattison-Gordon - Health-care organizations need to up their defenses as cyber attacks increasingly hit the sector. Focusing on identity and access management, patching key vulnerabilities, providing training on phishing and adopting strong backup practices can all go a long way. Read Full Article…

HVBA Article Summary

1. Increasing Ransomware Attacks and Health Data Vulnerability: In 2023, ransomware attacks on the healthcare sector surged by 128 percent, compromising sensitive data like the April attack on Change Healthcare, which exposed information on approximately 100 million individuals. Connected systems and the need for uninterrupted care make healthcare organizations particularly vulnerable to cyber threats, according to CMS acting CISO Keith Busby.

2. The Irreplaceable Nature of Health Records: Unlike bank or credit card details, stolen health information cannot be easily replaced, making it highly valuable on the black market. Stolen records can be used for fraudulent insurance claims, potentially blocking legitimate patients from accessing needed care, explained Benjamin Koshy, CISO of the Indian Health Service.

3. Evolving Cybersecurity Standards and Key Prevention Measures: Basic HIPAA compliance is now considered insufficient against today's threats. Experts advocate adopting stronger standards like NIST or HITRUST frameworks. New York hospitals are leading with enhanced requirements, including appointing CISOs and implementing multifactor authentication. Emphasis on identity and access management, phishing training, third-party risk assessments, and robust backup protocols are recommended strategies for healthcare organizations to mitigate cyber risks.

BCBS Minnesota settles with state over mental health access

By Jacob Emerson - Minnesota's Attorney General has reached a settlement with Blue Cross and Blue Shield of Minnesota regarding accessibility of mental health services. Read Full Article…

HVBA Article Summary

1. Settlement Terms and Financial Commitments: As part of a settlement with the Minnesota Attorney General’s Office, Blue Cross Blue Shield of Minnesota (BCBSM) agreed to a conditional $300,000 civil penalty if found in violation by 2028 and committed an additional $600,000 donation to support Minnesota State University-Mankato’s Center for Rural Behavioral Health.

2. Improved Timelines for Behavioral Health Requests: BCBSM has committed to expedite processes, including making decisions on prior authorization requests for behavioral health services within five days and processing provider network applications within 45 days.

3. Enhanced Oversight and Compliance Measures: To ensure adherence to mental health parity laws, BCBSM will pay for a state-selected consultant to monitor its practices, provide regular data to the state, and respond within 30 days to any behavioral health parity complaints filed with the Attorney General’s Office.

Americans hungry for weight-loss drugs grapple with supply and insurance hurdles

By Patrick Wingrove and Bhanvi Satija - Americans are still eagerly seeking prescriptions for Eli Lilly (LLY.N), and Novo Nordisk's (NOVOb.CO), weight-loss and diabetes drugs but cannot always fill them because of supply issues and insurance hurdles, according to their doctors. Read Full Article…

HVBA Article Summary

1. Growing Demand for Compounded Versions: The high cost and limited insurance coverage of branded weight-loss and diabetes medications like Zepbound and Wegovy are driving patients toward more affordable compounded versions sold online, despite questions about efficacy and safety.

2. Supply Chain and Shortage Issues: Although Lilly and Novo have been working to address shortages of Zepbound and Wegovy, intermittent supply issues remain, leading patients to search multiple pharmacies or turn to compounded alternatives. Lilly’s efforts to remove Zepbound from the FDA’s shortage list may have been premature, according to analysts, with some supply issues still unresolved.

3. Impact on Market and Industry Reactions: The shift toward compounded drugs is influencing the market, with companies like Noom and Hims & Hers catering to this demand. Analysts estimate that millions in the U.S. may be using compounded versions, potentially impacting sales of the branded drugs.

PBGH CEO: Transparency is “Table Stakes” and an “Expectation”

By Marissa Plescia - Employers have a fiduciary duty to ensure they’re providing their employees with the best medical benefits for the best price. However, they’re often struggling to access their data from their third-party administrators in order to do this. Read Full Article…

HVBA Article Summary

1. Increased Employer Accountability and Data Access: The Consolidated Appropriations Act of 2021 mandates employers to have better access to their healthcare claims data, preventing third-party administrators (TPAs) from restricting this access. As employers face rising accountability in healthcare procurement, industry leaders, like Elizabeth Mitchell of the Purchaser Business Group on Health (PBGH), emphasize that transparency is now a standard expectation.

2. Legal Tensions and Fiduciary Responsibilities: Employers are under scrutiny for their fiduciary duties, with cases like Kraft Heinz versus Aetna and Johnson & Johnson demonstrating the legal risks of insufficient data transparency and potential overpayment for healthcare services. The growing trend of lawsuits from employees against employers signals the legal pressures to uphold fiduciary responsibilities and ensure cost-effective healthcare spending.

3. Strategies for Employer Data Use and Direct Contracting: Organizations like PBGH are actively guiding employers to better fulfill their fiduciary roles by using data to identify high-value providers and implementing direct contracting with healthcare providers to cut costs and improve care quality. This shift aims to reshape employer-TPA relationships, with PBGH also working alongside Congress to advocate for clearer roles, responsibilities, and transparency among healthcare plan administrators and third-party vendors.

Why your next prescription could include an app

By Tina Reed - Federal regulators are confronting a new twist in drug development: manufacturers that include software with the medicine to prod patients to take pills as directed, manage side effects or track how well a treatment works. Read Full Article… 

HVBA Article Summary

1. Integration of Digital Health and Medications: Prescription drug use-related software (PDURS) is merging the worlds of digital health and pharmaceuticals by offering apps that support drug therapies, providing a more personalized approach to managing chronic conditions like depression, obesity, and musculoskeletal disorders. This approach aims to enhance the clinical value of drugs and improve patient adherence and outcomes.

2. Regulatory Challenges and FDA Involvement: As drugs and digital tools converge, the FDA is developing new guidelines to ensure these combined therapies are safe and effective. This includes distinguishing between approved software that complements drugs and those that could make unsupported claims, requiring close oversight to manage patient safety and prevent misuse.

3. Market Implications and Reimbursement Considerations: The integration of digital therapeutics with drugs is expected to impact prescribing practices and may influence insurance reimbursement policies. As pharmaceutical companies explore software-enhanced drugs to differentiate from generics, insurers and payers are closely evaluating the clinical benefits and cost-effectiveness of these innovations.

ACA individual health enrollment opens, fueled by ICHRA interest

By Allison Bell - The possibility that this may be the year when U.S. employers can provide cash that workers can use to buy their own health coverage is adding a little extra buzz to the start of the HealthCare.gov open enrollment period. Read Full Article… ^{_{(Subscription required)}}

HVBA Article Summary

1. Open Enrollment Period Initiation: The Centers for Medicare and Medicaid Services has launched the enrollment period for individual and family health plans for 2025, which runs from today until January 15, 2025, on HealthCare.gov and various state-based exchanges.

2. Individual Coverage Health Reimbursement Arrangements (ICHRAs): Companies are increasingly promoting ICHRAs, which allow employers to provide cash for employees to purchase health coverage through ACA exchange programs. This shift reflects growing interest in the individual health insurance market amid challenges in the Medicare and employer plan sectors.

3. Market Dynamics and Political Context: HealthCare.gov currently supports around 16 million enrollees, highlighting its significant role in the health insurance market. The open enrollment period coincides with political discussions surrounding the ACA, especially as elections approach, with contrasting views on the future of the ACA from current and potential future administrations.

Baxter International restarts IV fluid solutions manufacturing at largest plant

By Heather Landi - Baxter International restarted its highest-throughput intravenous solutions manufacturing line at its hurricane-hit North Cove facility in North Carolina, the company announced Thursday. Read Full Article… 

HVBA Article Summary

1. Recovery and Restart of North Cove Production: Baxter has made significant progress in recovering its North Cove manufacturing facility, impacted by Hurricane Helene, and aims to restart its highest-throughput IV solution line by mid- to late November. This initial production will undergo stringent quality control in line with regulatory standards before distribution, with further phases of restoration planned to gradually increase output.

2. Federal and Global Support Initiatives: In response to the critical shortage of IV fluids due to the hurricane’s impact, Baxter has activated additional global manufacturing sites, with the FDA authorizing temporary importation from seven international facilities. The U.S. government, including the FDA, HHS, and ASPR, has supported these efforts through expedited regulatory measures, invoking the Defense Production Act, and coordinating airlifts to alleviate supply issues.

3. Enhanced Allocations and Conservation Measures: Baxter has increased its allocation levels for hospitals and distributors to 60% and is working to scale up production at North Cove to reach near-full capacity by year-end. Meanwhile, HHS has recommended conservation strategies for healthcare providers, including postponing non-urgent procedures and facilitating in-house IV compounding to mitigate the impact of ongoing supply constraints.