In the GLP-1 Era, Clinical Guidelines for Obesity Care Are Urgently Needed

By Dr. Rekha Kumar - While the attention GLP-1s are receiving is exciting for medical professionals like me who've specialized in obesity treatment for decades, with little fanfare, the ‘miracle drug’ message is misleading and harmful. The anti-obesity and diabetes drug semaglutide — known by its brand names Ozempic and Wegovy — has taken the medical community by storm. Physicians who regularly dished out the go-to prescription of diet and exercise now have an effective and reliable medication to help patients with chronic weight management. Read Full Article…

VBA Article Summary

1. The anti-obesity and diabetes drug semaglutide, known by brand names Ozempic and Wegovy, has gained significant attention as a promising solution to chronic weight management. However, the emerging narrative of these drugs being a quick-fix solution is misleading. Physicians and healthcare leaders need to establish clear clinical guidelines for their use to ensure proper treatment and prevent misuse of these medications​¹​.

2. The hype around GLP-1 drugs, including semaglutide, has led to patients demanding the drug without appropriate diagnosis or consideration of lifestyle factors. Clinics built around these drugs promise quick weight loss, but relying solely on a drug for weight loss is unsustainable and can set patients up for failure. A well-rounded treatment approach that includes lifestyle changes is needed to ensure long-term success​¹​.

3. Obesity medicine is a relatively new field with most doctors not being trained in obesity care. While GLP-1 drugs like semaglutide are generally safe, a small percentage of users might experience severe side effects. It's crucial that anyone considering these drugs undergo a medical history screening before usage. The use of medication to treat obesity dates back to 1959, but the field gained clinical relevance only after the discovery of the hormone leptin in 1995​¹​.

ASCO Recap: Multiple Myeloma Moves, ADC Advances & Brain Cancer Progress

By Frank Vinluan - During the annual meeting of the American Society of Clinical Oncology, a cell therapy posted clinical data that could broaden its use in multiple myeloma. In other developments, the class of drugs called ADCs continue to make progress and a novel brain cancer drug has Phase 3 data that support its use as a new treatment option. Read Full Article… 

VBA Article Summary

1. Carvykti, from Legend Biotech and Johnson & Johnson subsidiary Janssen, has shown promising results in moving the cell therapy into earlier lines of multiple myeloma treatment. Clinical data presented at the ASCO meeting indicated that the cell therapy reduced the risk of disease progression by 74% in patients who no longer respond to multiple myeloma drug Revlimid. After these results, Janssen and Legend are seeking to expand regulatory approvals to include earlier lines of treatment​¹​.

2. Elahere is an antibody drug conjugate (ADC) developed by ImmunoGen that targets folate receptor alpha, a protein found on ovarian cancer cells. The FDA has given accelerated approval for the treatment of patients whose ovarian cancer expresses high levels of folate receptor alpha. Based on positive results from a Phase 3 trial, ImmunoGen plans to seek full FDA approval of Elahere and approval in Europe later this year​¹​.

   Adjuvants, drugs used to catch cancer cells missed by the initial treatment and to keep the cancer from coming back, saw some promising developments at the ASCO meeting. AstraZeneca’s osimertinib (Tagrisso) showed that it helps patients live longer, making it the first targeted therapy to show significant overall survival benefit in the adjuvant setting. Additionally, Novartis reported Phase 3 data that supports wider use of its breast cancer drug Kisqali as an adjuvant, with the potential to more than double the number of patients who could benefit from it​¹​.

3. Vorasidenib, a drug developed by Servier Pharmaceuticals, offers a potential alternative treatment for diffuse gliomas, a form of brain cancer. This experimental drug penetrates the blood-brain barrier to block two enzymes that contribute to the progression of gliomas. Phase 3 data suggests that the once-daily pill reduced the risk of tumor progression or death by 61% compared to a placebo. After the release of the Phase 3 data, Servier plans to discuss with the FDA an application seeking regulatory approval​¹​.

From AI oversight to noncompete contracts, these issues were top of mind for physician leaders at AMA's policy meeting

By Heather Landi - The country’s largest physician organization is taking a strong stance against noncompete contracts for physicians and is redoubling efforts to urge Congress to boost Medicare payments. At its annual meeting in Chicago this week, the American Medical Association’s (AMA's) House of Delegates adopted a new policy that declared Medicare physician payment reform an "urgent advocacy and legislative priority" for the organization. Read Full Article…

VBA Article Summary

1. Medicare Physician Payment Reform: 

   • The AMA will prioritize significant increases in funding for federal and state advocacy budgets specifically allocated to achieve Medicare physician payment reform.

   • Efforts aim to ensure that physician payments are updated annually at least equal to the annual percentage increase in the Medicare Economic Index.

   • The AMA contends that physicians are one of the only Medicare providers without an inflationary payment update, and these payment issues disproportionately affect small, independent, rural, and marginalized physician practices.

2. Noncompete Clauses:

   • The House of Delegates took action to ban noncompete contracts for physicians employed by hospitals, hospital systems, or staffing companies.

   • Policies were adopted to oppose the use of restrictive covenants not-to-compete for physicians-in-training.

   • The AMA highlights the need to enhance specialist coverage in communities, improve patient access to care, and reduce healthcare disparities by allowing physicians to work for multiple hospitals.

3. Regulation of Artificial Intelligence (AI) in Healthcare:

   • The AMA calls for greater regulatory oversight of insurers' use of AI in reviewing patient claims and prior authorization requests.

   • Health insurers utilizing AI technology should implement a fair process based on clinical criteria, including reviews by physicians and healthcare professionals with expertise in the service under review.

   • The AMA emphasizes the need to reduce the burdensome volume of prior authorization requirements and protect patients from false or misleading AI-generated medical advice.

You Likely Owe Nothing for Your Preventive Service

By Tia Goss Sawhney - Twice in the last two years, I have been informed that I must pay for preventive services as I had not satisfied my deductible. In both cases, I owed nothing, and the full amount was ultimately paid by my insurance company. The demand for my payment was the result of a health insurance claim coding error by the billing staff of my medical group. One would think that the billing staff of one of the largest medical groups in New Jersey would know how to correctly bill New Jersey's largest health insurance company for routine services, but obviously not. Read Full Article…

VBA Article Summary

1. Preventive Care and Insurance: Individuals who have insurance through their employer or purchase health insurance on their own, with or without a government subsidy, are entitled to an array of preventive care services without any cost-sharing. The exception is for plans that have been essentially unchanged since 2010, known as "grandfathered" plans. Per the Affordable Care Act (ACA), non-grandfathered plans must provide a minimum list of preventive care services without cost sharing, and some plans have expanded on these services. However, instances of misbilling and confusion in coding can lead to patients being incorrectly charged for these services​¹​.

2. Specific Cases of Misbilling: Screening colonoscopies are particularly prone to misbilling. Despite federal clarifications in 2015 that screening colonoscopies must be covered under private, non-grandfathered health plans as a preventive service without any cost-sharing, patients continue to be billed for these services. Another area of confusion is the intent of the visit, where diseases can be diagnosed and even minimally treated during a preventive care service if the service is performed with the intent of providing preventive care​¹​.

3. Contentious Coverage for Contraceptive Services: While most health plans cover contraceptive services, some plans object to providing the coverage and claim a religious or moral exemption. In such cases, they can notify the federal government, which will then provide contraceptive services to the covered person without cost to the plan. In January 2023, the federal government proposed a rule that will provide women covered under such plans direct access to government-paid contraception without any plan involvement. However, as of the end of May, this rule is not yet final​¹​.

Methodist Le Bonheur announces deal with Blue Cross Blue Shield

By Omer Yusuf - Methodist Le Bonheur Healthcare announced Wednesday it has reached an agreement with Blue Cross Blue Shield of Tennessee regarding its employer-based and marketplace plans. “We are pleased to have reached an agreement after months of advocating for the best interests our patients,” said Michael Ugwueke, president and CEO of Methodist Le Bonheur Healthcare, in a statement. “We look forward to continuing to provide the safest and highest quality care in the Mid-South community for all we are privileged to serve.” Read Full Article… 

VBA Article Summary

1. Methodist Le Bonheur Healthcare announced that it has reached an agreement with Blue Cross Blue Shield of Tennessee for employer-based and marketplace plans. This agreement comes after months of advocacy for patient interests by Methodist Le Bonheur Healthcare​¹​.

2. Blue Cross Blue Shield of Tennessee members have been out-of-network at Methodist facilities since the beginning of the year when the two sides failed to reach a deal before their contract expired. This affected both inpatient and outpatient care at Methodist facilities. The dispute arose due to Blue Cross's contention that Methodist was charging higher rates than other facilities in the Memphis area, and they demanded a 40% rate reduction. Methodist, however, maintained that their rates were fair and refused to consider the proposed cut​¹​.

3. Despite the apparent standstill in negotiations since early February, there was renewed optimism in May when the two parties began to exchange proposals. Blue Cross Blue Shield of Tennessee expressed optimism that an agreement would be reached soon. The recent deal is hoped to lower healthcare prices for Memphians and result in lower premiums for Blue Cross members​¹​.

Suicides and homicides among young Americans jumped early in the pandemic, study says

By Mike Stobbe - The homicide rate for older U.S. teenagers rose to its highest point in nearly 25 years during the COVID-19 pandemic, and the suicide rate for adults in their early 20s was the worst in more than 50 years, government researchers said Thursday.The Centers for Disease Control and Prevention report examined the homicide and suicide rates among 10- to 24-year-olds from 2001 to 2021. Read Full Article… 

VBA Article Summary

1. The homicide rate for older U.S. teenagers (15-19 years old) and the suicide rate for adults in their early 20s reached alarming levels during the COVID-19 pandemic. The homicide rate for teenagers rose to its highest point in nearly 25 years, and the suicide rate for early adults was the worst in over 50 years. Suicide and homicide became the second and third leading causes of death, respectively, for individuals between 10 to 24 years old. These increases have prompted concerns about a mental health crisis among young people, with contributing factors suggested to be higher rates of depression, limited availability of mental health services, and the prevalence of guns in U.S. homes​¹​.

2. Guns played a significant role in these deaths, with firearms used in 54% of suicides and 93% of homicides among this age group in 2021​¹​.

3. While suicide and homicide rates were considerably higher for older teenagers and young adults compared to 10- to 14-year-olds, there were still substantial numbers in each age group. For instance, in 2021, there were around 2,900 suicides and 3,000 homicides among youths aged 10 to 19, and approximately 4,200 suicides and 3,900 homicides among those aged 20 to 24. Homicide deaths became more common than suicides in the 15 to 19 age group, whereas suicide was more prevalent in the younger and older age groups. It's important to note that while large increases in homicide rates were seen for young Black and Hispanic people in the U.S., there were not significant increases for their white counterparts​¹​.

An additional point worth mentioning is that suicide rates among children and teenagers were already on the rise prior to the pandemic, but these rates significantly escalated at the onset of COVID-19. The reasons behind this are not entirely clear, but the isolation experienced during lockdowns could be a contributing factor​¹​.

Part 2: Who Regulates Healthcare AI?

By Joanne Byron - Artificial Intelligence/Machine Learning has gained heightened attention globally. Augmented Intelligence has been embraced as a concept by physician organizations to underscore that emerging AI systems are designed to aid humans in clinical decision-making, implementation and administration to scale healthcare, according to Act Online Key Terminology for AI in Health. Although the United States is making progress in developing domestic AI regulation, including with the National Institute of Standards and Technology (NIST) AI Risk Management Framework, the Blueprint for an AI Bill of Rights, and existing laws and regulations that apply to AI systems is still a work-in-progress. The goals are to protect people from unsafe or ineffective systems. Read Full Article… 

VBA Article Summary

1. Federal Agencies' Joint Statement: On April 25, 2023, the Federal Trade Commission (FTC), the Civil Rights Division of the U.S. Department of Justice (DOJ), the Consumer Financial Protection Bureau (CFPB), and the U.S. Equal Employment Opportunity Commission (EEOC) released a joint statement expressing their commitment to protecting individuals from the potential negative impacts of artificial intelligence (AI) and automated systems. They emphasized the need to address biases, transparency issues, and flawed designs as AI becomes more integrated into daily life.

2. FTC Concerns and Actions: The Federal Trade Commission (FTC) plays a role in protecting consumers and competition. In May 2023, the FTC warned about the privacy and security concerns associated with the increasing use of biometric information and related technologies powered by machine learning. The FTC's actions aim to limit deceptive or exaggerated claims made by healthcare organizations regarding the capabilities of medical devices or AI software.

3. FDA's Oversight and Guidance: The Food and Drug Administration (FDA) has been actively involved in regulating AI/ML-based medical software. They released an action plan in 2021 and published draft guidance in April 2023, proposing a science-based approach to ensure the safety, effectiveness, and rapid modification of AI/ML-enabled devices in response to new data. The FDA's efforts aim to accelerate medical device innovation, enable personalized medicine, and empower healthcare providers and users.

Note: The article also mentions the National Institute of Standards and Technology's (NIST) AI Risk Management Framework and its voluntary use to incorporate trustworthiness considerations into AI products and services. Additionally, it highlights the relevance of the Health Insurance Portability and Accountability Act (HIPAA) and the need for a robust HIPAA program in the context of AI technologies in healthcare.