Insurers and Private Equity Look to Join Forces to Further Consolidate Control of Americans' Access to Health Care

By Wendell Potter - The push and pull between providers and insurance companies is as old as our health payment system. Doctors have long argued insurers pay too little and that they too often interfere in patient care. Dramatic increases in prior authorization, aggressive payment negotiations and less-generous reimbursement to doctors by Medicare Advantage plans show there’s little question the balance of power in this equation has swung toward payers. Read Full Article…

HVBA Article Summary

1. Private Equity Partnerships in Healthcare: Many doctors are turning to private equity investments to maintain financial stability and operational efficiency. This trend of private equity acquisitions in physician practices has attracted federal scrutiny due to its potential impact on healthcare delivery and cost structures. Insurers have also taken notice, with CVS/Aetna reportedly seeking a private equity partner to expand Oak Street Health, a primary care provider for Medicare recipients.

2. Political and Regulatory Landscape: The scrutiny of private equity in healthcare is bipartisan, with Republicans focusing on pharmacy benefit managers and Democrats criticizing private equity’s role. A joint venture between private equity and CVS/Aetna’s Caremark, a major PBM, could raise concerns among lawmakers. The integration of insurers and PBMs, as seen with United Healthcare and Optum, CVS/Aetna and Caremark, and Cigna and Express Scripts, has centralized control over healthcare decisions, impacting claim approvals, payment rates, and patient costs.

3. Market Dynamics and Potential Monopolistic Behavior: CVS/Aetna's strategy to expand Oak Street Health and control primary care referrals could significantly influence specialist contract negotiations and patient utilization. By owning primary care clinics, CVS/Aetna can direct referrals to affiliated specialists and pharmacies, potentially reducing reimbursement rates and increasing market power. While this model might skirt federal Anti-Kickback Statute and Stark Law due to common ownership, it raises antitrust concerns and underscores the need for closer examination of insurer control over healthcare providers.

Drug Shortages Keep Growing. Older, Injectable Agents Are Among the Most Vulnerable.

By Associated Press - Erin Fox, PharmD, MHA, has tracked drug shortages for more than 20 years, and she sees no easy solutions for what has become a record run. Total active shortages hit an all-time high of 323 in this year's first quarter, according to the University of Utah Drug Information Service. That's up about 86% from a 10-year low of 174 last reached in 2017. Read Full Article…

HVBA Article Summary

1. Persistent Drug Shortages: In the first quarter of this year, 48 new drug shortages were recorded, highlighting ongoing supply chain issues. These shortages often involve generic, injectable hospital drugs, which are typically low-cost and lack supply chain resilience. Quality issues at manufacturing plants, exacerbated by delayed FDA inspections during COVID-19, are significant contributors to these shortages.

2. Challenges in Addressing Root Causes: Addressing the root causes of drug shortages remains challenging. The FDA's resumption of factory inspections has identified quality deficits requiring lengthy fixes, disrupting production schedules. Meanwhile, other manufacturers often lack the capacity to compensate for these disruptions, further exacerbating the supply issues.

3. Potential Solutions and Positive Developments: Despite the challenges, there are signs of progress. Increased Congressional interest and discussions on drug shortages indicate a commitment to addressing the issue through policy and potential legislative action. Patients are advised to stay informed and proactive, as alternative treatment options and insurance adjustments can help mitigate the impact of shortages.

Cyberattack led to harrowing lapses at Ascension hospitals, clinicians say

By Rachana Pradhan and Kate Wells - In the wake of a debilitating cyberattack against one of the nation’s largest health care systems, Marvin Ruckle, a nurse at an Ascension hospital in Wichita, Kansas, said he had a frightening experience: He nearly gave a baby “the wrong dose of narcotic” because of confusing paperwork. Read Full Article…

HVBA Article Summary

1. Cyberattack Impact on Patient Care: The May 8 ransomware attack on Ascension, a Catholic health system, severely disrupted its electronic health records and other critical systems, leading to significant lapses in patient care. Clinicians across multiple states reported delays or errors in lab results, medication administration, and safety checks, resulting in life-threatening situations and increased potential for harm.

2. Unpreparedness for Extended Downtime: Ascension's response highlighted a lack of preparedness for prolonged system outages. Despite claims of being trained for such disruptions, many clinicians, including those at Ascension Via Christi St. Joseph, found themselves navigating uncharted territory without adequate training or support, resorting to inefficient paper-based systems and makeshift solutions.

3. Calls for Improved Cybersecurity and Staffing: The attack underscored the urgent need for robust cybersecurity measures and better preparation for cyber incidents in healthcare. Meanwhile, staff at affected hospitals, like those in Michigan, called for increased staffing and temporary reductions in non-emergency procedures to manage the crisis more effectively. Despite these pleas, many reported that their concerns were ignored, exacerbating the strain on both staff and patients.

California Clinic Elevates Role of Midwives In Maternal Care

By Christopher Cheney - Millie, a maternal care clinic based in Berkeley, Calif., features a midwife-led care model with doulas also providing support to patients. A report published earlier this month by The Commonwealth Fund provides insights into the U.S. maternal mortality crisis. The report found that the United States has a higher maternal mortality rate than 13 other high-income countries. Read Full Article…

HVBA Article Summary

1. Collaborative Midwifery Care Model: Millie offers a care model where midwives lead patient care with the support of doulas for prenatal and postpartum periods. This model allows for collaboration with physicians for high-risk pregnancies, ensuring patients receive appropriate care levels. This approach emphasizes the role of midwives while integrating necessary medical support when required.

2. Cost-Effective and Outcome-Driven: Millie’s care model is more cost-effective compared to traditional OB/GYN-led clinics, primarily due to lower staffing costs and efficient management of care. The clinic’s focus on early detection and management of risks has resulted in better clinical outcomes, such as lower C-section rates, preterm birth rates, and low birthweight occurrences compared to national averages.

3. Addressing Provider Shortages: The United States faces a shortage of midwives and obstetrician-gynecologists compared to other high-income countries. Millie's model demonstrates that increased reliance on midwives can help address this shortage and improve maternal care outcomes. The collaboration between midwives and physicians offers a sustainable solution to the maternal mortality and morbidity crisis by optimizing the roles of different care providers.

FTC backs plan to target more patent settlements it sees as anticompetitive

By Zachary Brennan - The Federal Trade Commission on Tuesday offered up support for a proposed rule from the US Patent and Trademark Office that could help regulators more closely track pharma patent settlements that might be anticompetitive. Read Full Article…

HVBA Article Summary

1. Expanded Disclosure Requirements: The FTC's proposed rule under the PTO calls for broader disclosure of settlements that currently evade mandatory reporting. This initiative aims to uncover potentially anticompetitive behaviors, particularly focusing on undisclosed settlements, such as reverse payment agreements between brand-name and generic pharmaceutical companies.

2. FTC's Rationale and Goals: According to the FTC, extending disclosure requirements would enhance their ability to identify and investigate unlawful settlements within the pharmaceutical sector and beyond. This move is part of a broader strategy to monitor and mitigate practices that hinder market entry of lower-cost generics, thus promoting competitive pricing.

3. Industry Response and Concerns: Industry stakeholders, including PhRMA, advocate for separate consideration of settlement agreements outside the PTO rulemaking. They argue for a nuanced approach that addresses confidentiality concerns surrounding sensitive business information. PhRMA suggests a distinct regulatory framework to manage these issues effectively, ensuring that proprietary information remains protected while complying with regulatory oversight.

Prior authorization is 'wreaking havoc': AMA survey

By Mariah Taylor - Prior authorization is "wreaking havoc" on patient outcomes, physician burnout and productivity, a recent American Medical Association survey found. Read Full Article…

HVBA Article Summary

1. Impact on Patients:

   • Ninety-four percent of surveyed physicians reported that prior authorizations create delays in care, significantly impacting patient treatment timelines.

   • Twenty-four percent of physicians indicated that prior authorizations led to adverse events, including hospitalizations (19%), life-threatening events (13%), and severe outcomes such as disability or death (7%).

   • Seventy-nine percent of respondents stated that prior authorizations sometimes force patients to pay for medication out of pocket, adding financial strain.

2. Impact on Physicians:

   • On average, each physician handles 43 prior authorizations per week, dedicating approximately 12 hours weekly to this paperwork, significantly burdening their practice.

   • Thirty-five percent of physicians have staff solely dedicated to managing prior authorizations, highlighting the administrative load.

   • A significant majority (95%) of physicians feel that the prior authorization process contributes to burnout, with 27% reporting frequent denials of their requests.

3. General Findings:

   • Over one-third of physicians believe that the criteria for prior authorizations are rarely or never evidence-based, questioning the validity of the process.

   • Eighteen percent of physicians always appeal denied prior authorizations, yet many do not because they anticipate unsuccessful outcomes based on past experiences.

   • The majority of physicians (87%) noted that prior authorizations lead to higher overall utilization of healthcare services, including additional office visits (68%) and increased emergency department visits (42%).

Insured patients often save less with Mark Cuban's drug company: Study

By Jakob Emerson - Individuals with health insurance are more likely to spend less on generic drugs when using their benefits compared to going through Mark Cuban's Cost Plus Drug Company, according to a study published June 14 in JAMA Health Forum. Read Full Article…

HVBA Article Summary

1. Variability in Savings by Insurance Type: The study found substantial variations in savings based on the type of health insurance, with uninsured patients benefiting the most. Uninsured individuals achieved the highest median estimated cost savings per prescription at $6.08, while military members saved $5.05, Medicare enrollees saved $4.64, and commercial insurance holders saved $3.69. No cost savings were observed among Medicaid enrollees. Researchers emphasized the potential of transparent cost-plus pharmacy models like MCCPDC to reduce out-of-pocket costs for specific patient subsets.

2. Study Methodology and Findings: Researchers analyzed a sample of over 843 million prescription pharmacy fills for 124 generic drugs in 2019, matching them with drugs sold by Cost Plus in March 2023. Adjusting for drug cost changes from 2019 to 2023 using CMS' National Average Drug Acquisition Cost, they compared out-of-pocket costs to Cost Plus' prices. The study revealed that insured patients could have saved on 11.8% of prescriptions if purchased through Cost Plus, with an estimated saving of $4.96 per prescription including shipping. Among prescriptions with savings, 50.3% saw savings of less than $5, and 28.4% had savings greater than $10.

3. Comparison with Other Pharmacy Models and Observations: The study's findings aligned with a 2021 study of Costco’s direct-to-consumer pharmacy, which found higher spending among 11% of Medicare Part D claims, and a 2023 study showing higher out-of-pocket costs for 20% of Amazon Pharmacy’s Prime members. The researchers noted the dynamic nature of drug costs and supply at Cost Plus, which sold only 26% of available expensive generics in May 2023. Additionally, the study did not assess the potential savings of in-person prescription pickups, indicating a possible area for further research.

9 Requirements for an Optimal Genetic Test Benefit Program

By Jason Bush and Sarah Bretz - As health plans struggle to cope with the rapid growth in genetic testing, they’re finding that their programs for routine test management are not up to the task. Read Full Article…

HVBA Article Summary

1. Accreditation, Regulatory Compliance, and Coverage Criteria: Health plans must ensure utilization management is accredited by respected agencies like NCQA and URAC and maintain good standing with state regulatory agencies. Coverage criteria for genetic tests should be based on up-to-date scientific evidence, reviewed annually or as needed by experienced laboratorians, pathologists, and geneticists to ensure the latest clinical medicine is codified in medical policies.

2. Quality Evaluation and Prior Authorization: Ongoing evaluation of genetic test quality is essential, requiring health plans to ensure labs meet scientific, technical, and clinical standards. Expedited review processes for prior authorizations should be implemented using specific genetic billing codes, like those from MolDX®, to automate authorization, increase physician satisfaction, and reduce costs.

3. Fraud Prevention, Utilization Management, and Optimized Laboratory Networks: To prevent fraud, waste, and abuse, health plans should integrate enhanced claim-to-authorization matching processes and periodic laboratory audits. Continuous utilization management is crucial, alongside claims adjudication best practices. Identifying high-performing labs through quality evaluations and audits can optimize laboratory networks, offering increased benefits and potential cost reductions for health plans and patients.

Explainer: What other health conditions might weight-loss drugs treat?

By Reuters - Eli Lilly's LLY.N blockbuster diabetes drug Mounjaro and weight-loss therapy Zepbound, as well as Novo Nordisk's NOVOb.CO rival medicines Ozempic and Wegovy are being studied to see whether they can improve health in other ways. Read Full Article…

HVBA Article Summary

1. Alcohol Addiction and Neurological Disorders:

   • The University of Copenhagen's Psychiatric Centre Rigshospitalet is investigating semaglutide (Novo's Wegovy and Ozempic) for reducing alcohol intake in patients with alcohol use disorder and obesity.

   • Researchers at the Danish Headache Center are testing semaglutide with a very low-calorie diet for treating new-onset idiopathic intracranial hypertension, a condition linked to obesity.

2. Chronic Kidney Disease and Cardiovascular Disease:

   • Novo's Ozempic has shown promise in delaying the progression of chronic kidney disease in diabetes patients, reducing the risk of death and major cardiac events by 24%. However, this result fell short of investor expectations.

   • Eli Lilly's tirzepatide is being tested for heart failure and obesity, with a study involving 700 participants expected to conclude by July 2024. Additionally, tirzepatide is being evaluated in a mid-stage study of chronic kidney disease in obese patients, aiming to enroll up to 140 participants.

3. Liver Disease and Sleep Apnea:

   • Novo is conducting a late-stage trial of semaglutide for non-alcoholic steatohepatitis (NASH), expecting to enroll about 1,200 patients.

   • Lilly's tirzepatide showed significant efficacy in a mid-stage trial for metabolic dysfunction-associated steatohepatitis (MASH), with up to 74% of patients achieving disease absence without worsening liver scarring. It is also in late-stage testing for obstructive sleep apnea and obesity, targeting 469 participants.

Kansas accuses Pfizer of misleading public about COVID vaccine in lawsuit

By Brendan Pierson - The U.S. state of Kansas on Monday sued Pfizer (PFE.N), accusing the company of misleading the public about its COVID-19 vaccine by hiding risks while making false claims about its effectiveness. Read Full Article…

HVBA Article Summary

1. Allegations Against Pfizer: Kansas Attorney General Kris Kobach has filed a lawsuit alleging that Pfizer made misleading statements about its COVID-19 vaccine. The lawsuit claims Pfizer concealed evidence of vaccine-related pregnancy complications and heart inflammation since early 2021, violating the Kansas Consumer Protection Act.

2. Pfizer's Response and FDA Actions: Pfizer has denied the allegations, stating its vaccine communications were based on accurate and science-based information. The U.S. FDA had issued warnings about myocarditis and pericarditis linked to the vaccine in June 2021, primarily affecting adolescent boys and young men. A 2023 NIH review of 21 studies found no link between COVID vaccines and miscarriage.

3. Legal Landscape and Collaborative Efforts: Kansas' lawsuit is part of broader legal action involving other states investigating Pfizer's vaccine claims. Texas Attorney General Ken Paxton filed a similar lawsuit, still pending, echoing claims of misinformation. Kobach indicated that multiple states are expected to join Kansas in filing lawsuits, suggesting coordinated legal efforts against Pfizer.