Federal Trade Commission to sue three largest PBMs: WSJ

By Rebecca Pifer - PBMs negotiate savings called rebates with drugmakers in return for placing their drugs on a favorable tier of the PBM’s formulary, so that more people can access — and pay for — the drugs. The companies say they save people money on their medications. However, PBMs have long been criticized for opaque and confusing business practices that research suggests contribute to skyrocketing drug costs in the U.S. Read Full Article…

HVBA Article Summary

1. FTC Lawsuit Against Top PBMs: The Federal Trade Commission is gearing up to sue the three largest pharmacy benefit managers in the U.S.—CVS' Caremark, Cigna's Express Scripts, and UnitedHealth's Optum Rx—over their drug price negotiation practices with pharmaceutical manufacturers, focusing on discounts for drugs like insulin.

2. Market Power and Profit: The FTC's impending lawsuit follows an interim report from its nearly three-year investigation, which found that PBMs use their market power to profit at the expense of patients and independent pharmacists. This has intensified pressure on Washington to address drug prices, as almost one in three Americans delayed or skipped medication doses last year due to high costs.

3. Industry Consolidation Concerns: The FTC's analysis highlights the consolidation within the PBM industry, where Caremark, Express Scripts, and Optum Rx manage nearly 80% of all U.S. prescriptions. These PBMs, owned by major health insurers, allegedly steer patients to their own pharmacy networks, disadvantaging competitors and contributing to higher drug prices.

CMS proposes new payments for digital health under CY2025 PFS draft rule

By Emma Beavins - The Centers for Medicare & Medicaid Services' (CMS') proposed calendar year 2025 physician fee schedule rule, out Wednesday, proposed an assortment of new payments and coverage for digital health services, including digital therapeutics, telehealth and audio-only telehealth services. It did not, however, address the bulk of Medicare telehealth waivers expiring at the end of the year, which need to be extended by Congress. Read Full Article…

HVBA Article Summary

1. Telehealth and Audio-Only Services: The draft rule proposes that rural health clinics (RHCs) and federally qualified health centers (FQHCs) continue receiving payments for audio-only telehealth services. It also waives the in-person visit requirement for telemental health services through the end of 2025, and refines payment codes such as G0511 for remote monitoring services.

2. Opioid Treatment Programs: CMS proposes significant changes for opioid treatment programs, including the permanent allowance of audio-only and audio-visual telehealth visits for assessments and the induction of patients into buprenorphine and methadone treatments, enhancing flexibility and access to care.

3. Digital Therapeutics and Remote Monitoring: CMS introduces three new codes for digital mental health treatment devices in the CY2025 physician fee schedule draft rule, allowing reimbursement for FDA-cleared digital therapeutics. Despite these additions, there are concerns about the substantial impact of these new codes compared to existing ones, and ongoing issues with remote therapeutic monitoring reimbursements and data reporting requirements remain unaddressed.

FDA’s lab-developed test rule could be first test of agency’s power post-Chevron

By Susan Kelly and Elise Reuter - The recent U.S. Supreme Court decision to overturn the Chevron doctrine could open the door to more challenges of Food and Drug Administration regulations, including the agency’s controversial rule on lab-developed tests. Read Full Article…

HVBA Article Summary

1. Supreme Court Overturns Chevron Deference: In a landmark decision, the Supreme Court voted 6-3 to overturn the Chevron deference principle, significantly changing how courts interpret federal agency decisions. This ruling, stemming from cases involving monitoring requirements for fisheries, will likely impact all federal agencies, including the FDA.

2. Implications for FDA and Medical Device Industry: The decision is expected to have profound effects on the FDA's regulatory authority, especially in ongoing litigation concerning the FDA’s final rule on lab-developed tests (LDTs). Legal experts predict that this ruling could serve as a bellwether for how the FDA’s regulatory actions will be challenged in the future, particularly those involving statutory interpretation.

3. Increased Legal Challenges and Industry Adjustments: With Chevron deference overturned, the FDA may face more frequent and vigorous legal challenges. While the agency’s scientific and technical decisions will still command respect, it will need to provide stronger justifications for its regulatory actions. This change is anticipated to slow down FDA policymaking and lead to increased litigation from industry stakeholders.

As Gen X turns 60, this generation doubts their retirement readiness

By Lynn Cavanaugh - As the oldest Gen Xers, who were born between 1965 and 1980, are set to turn 60 in 2025, this typically self-reliant generation of employees has a lot of anxieties, as they're entering the "pre-retiree" phase of planning – and may be looking to accelerate savings, according to a new Natixis Investment Managers report, "Reality Bites: Retirement anxieties grow as Generation X turns 60." Read Full Article…

HVBA Article Summary

1. Growing Concerns About Retirement: Nearly half of Gen Xers surveyed (48%) feel it's going to take a "miracle" to retire securely. This generation is anxious about their financial future, with 37% worried about potential cuts to Social Security benefits and many fearing they will deplete their savings covering healthcare costs. Despite these concerns, 47% are unsure if they will be able to work long enough to ensure a stable retirement.

2. Inconsistent Investment Expectations: Gen X investors often harbor misplaced optimism about their investment strategies, with misconceptions about risk and passive investments. This disparity between expectations and reality underscores the need for better financial education and guidance to align their investment approaches with realistic outcomes.

3. Professional Financial Planning Needs: A significant portion of Gen X (48%) is seeking financial planning services, and 44% are looking for retirement income planning. Advisors and employers can support these needs by highlighting opportunities such as catch-up contributions under SECURE 2.0, which will allow older workers to save more starting in 2025. Demonstrating the gap in their retirement savings can motivate Gen Xers to take more proactive steps towards a secure retirement.
   

Health-Care Companies Are Sending Your Data to Big Tech

By Jessica Nix - California-based health system Kaiser Permanente recently alerted millions of people that their private information was inappropriately shared with tech giants, angering patients who weren’t aware of the practice. Read Full Article…

HVBA Article Summary

1. Privacy Concerns with Online Trackers: Bloomberg News analysis revealed that the nation's largest healthcare companies use online trackers on their websites, potentially exposing sensitive patient information to third-party companies without patients' consent. This includes details such as dates of birth, phone numbers, Social Security numbers, and even passwords, which can be accessed by companies like Meta, Adobe, and Quantum Metric.

2. Regulatory and Legal Actions: Federal regulators, including the FTC and the Health and Human Services Department, have been working to address the privacy issues related to online trackers on health websites. Despite efforts to issue guidance and penalize companies for improper data sharing, legal challenges have arisen, such as a Texas judge limiting the HHS's authority to enforce these rules, highlighting the complex legal landscape surrounding health data privacy.

3. Impact and Industry Response: The use of trackers on healthcare websites has significant implications, contributing to a $250 billion market for personal information. Healthcare companies like Kaiser Permanente and CVS have faced lawsuits and regulatory scrutiny, leading some to remove trackers from their websites. The industry is under increasing pressure to improve transparency and ensure compliance with privacy laws, with experts warning that many healthcare organizations might not fully understand the extent of their data collection practices.

How Chevron's demise could impact employers, purchasers and health payers

By Noah Tong - Healthcare legal observers are still reacting to the Supreme Court’s recent decision to gut the Chevron doctrine, fundamentally altering the power federal agencies have to handle regulations as they find appropriate. Read Full Article…

HVBA Article Summary

1. Impact on Self-Funded Employers and Payers: The Supreme Court's ruling could significantly affect self-funded employers and how payers allocate resources and operate. Smaller plans may face difficulties adapting to the new legal landscape, while larger plans have more resources but also more complexities, especially across state lines. Jenn Kerfoot of DUOS highlighted the need for payers to create uniform guidance and be pragmatic as they navigate these changes.

2. Challenges to Agency Deference and Legislative Clarity: The overturning of the Chevron doctrine raises concerns about the deference given to federal agencies like HHS. Critics argue that this change places an undue burden on courts and Congress to interpret and create clear laws. Shawn Gremminger of the National Alliance of Healthcare Purchaser Coalitions expressed worries about the potential for "district shopping" and prolonged legal battles over regulations, emphasizing the need for healthcare expertise in judicial decisions.

3. Future of Federal Regulations and Litigation Risks: The decision may cause federal agencies to delay issuing new regulations due to increased uncertainty. Chris Deacon of VerSan Consulting predicted a "chilling effect" on regulatory actions, making it harder for vague legislation to be implemented effectively. Key areas to watch for potential litigation include hospital reimbursements and elements of the Mental Health Parity and Addiction Equity Act, though other issues like reproductive rights and hospital price transparency may not yet be ripe for legal challenges.

UnitedHealth Group, officials sued over Justice Department probe

By Andrew Cass - UnitedHealth Group and several of the company's leaders are facing a shareholder derivative lawsuit alleging they failed to disclose that the Justice Department opened an antitrust investigation into the company. Read Full Article…

HVBA Article Summary

1. Investigation and Stock Impact: The public became aware of a Justice Department investigation into UnitedHealth's internal relationships, including those involving its segment Optum, on February 27, following reports from The Wall Street Journal and other media outlets. The disclosure caused a significant impact on UnitedHealth's stock price, which dropped 12% from $525.32 on February 26 to $513.42 on February 27, and continued to fall to $498.28 on February 28.

2. Lawsuit Allegations: Shareholder Portia McCollum filed a lawsuit on July 18 in Minnesota federal court, accusing UnitedHealth's leadership of breaching their fiduciary duties by issuing false and misleading statements to investors. The lawsuit contends that the company failed to maintain necessary firewalls between Optum and UnitedHealthcare, contrary to its own policies and prior court assurances.

3. Defendants and Misconduct: The lawsuit names 11 individual defendants, including UnitedHealth Group CEO Andrew Witty, chairman Stephen Hemsley, and UnitedHealthcare CEO Brian Thompson. It alleges these officials were aware of the investigation since October and sold substantial amounts of UnitedHealth stock based on non-public information. The lawsuit claims this misconduct has resulted in significant financial losses for the company and calls for corporate governance reforms to prevent future occurrences.

Telemental health visits decline when cost-sharing returns, new study finds

By Emma Beavins - In a study published in JAMA Network Open on Tuesday, Included Health and Harvard Medical School found that patients in high deductible health plans are less likely to seek virtual behavioral healthcare when costs are re-introduced. Read Full Article…

HVBA Article Summary

1. Impact of Cost-Sharing on Telemental Health Utilization: A study by Included Health and Harvard Medical School examined the effects of cost-sharing on telemental healthcare for 15,000 patients in high deductible health plans (HDHPs). When out-of-pocket costs were required, patients attended 1.5 fewer telemental health visits per month, and 11.7% stopped their visits altogether, highlighting the negative impact of financial barriers on mental health service utilization.

2. Pandemic-Era Waivers and Legislative Changes: During the COVID-19 public health emergency, Congress allowed health plans to waive cost-sharing for telehealth services in HDHPs, maintaining health savings account (HSA) eligibility. However, this waiver may lapse at the end of the year. Included Health's chief health officer, Ami Parekh, warns that reintroducing cost-sharing could lead to fewer patients using virtual behavioral health services, potentially worsening health outcomes.

3. Study Demographics and Findings: The study included patients from all 50 states and D.C., with a majority being 30-year-old white females. It compared two groups during six-month periods in 2021: one with cost-sharing reintroduced and one without. The intervention group, predominantly urban-based, had more patients with mild depression, while the control group had a higher percentage of moderate to severe depression cases. The findings suggest financial barriers significantly affect mental health service accessibility, particularly in urban areas.

Light at Night Tied to Diabetes Risk in Largest Study to Date

By Christina Szalinski - Concerned about your patient's type 2 diabetes risk? Along with the usual preventive strategies — like diet and exercise and, when appropriate, glucagon-like peptide 1 (GLP-1) agonists — there's another simple, no-risk strategy that just might help: Turning off the light at night. Read Full Article…

HVBA Article Summary

1. Link Between Nighttime Light Exposure and Diabetes Risk: A study published in The Lancet found that individuals exposed to the most light between 12:30 AM and 6 AM were 1.5 times more likely to develop diabetes compared to those who stayed in darkness during this period. This research is significant as it measured personal light exposure using wrist-worn sensors, unlike previous studies that relied on satellite data of outdoor light levels.

2. Study Findings and Methodology: Utilizing data from 85,000 participants in the UK Biobank, this study is the largest to date connecting diabetes risk to personal light exposure at night. Participants wore light sensors for a week to measure exposure from various sources, and researchers tracked their health for eight years. Those exposed to brighter light at night had a higher risk of developing type 2 diabetes, with a dose-response relationship observed — the brighter the light, the greater the risk.

3. Mechanism and Implications: Nighttime light disrupts circadian rhythms, which are crucial for biological processes like blood sugar management. Disruption in these rhythms can lead to insulin resistance, a precursor to type 2 diabetes. The sleep hormone melatonin, which helps regulate glucose and insulin responses, may also play a role. While further studies are needed to confirm interventional strategies, promoting healthy light exposure and sleep patterns could be beneficial in reducing diabetes risk.