National Cancer Institute Launches Precision Medicine Initiative

By Veronica Salib - On June 1, 2023, the National Cancer Institute (NCI), a subset of the NIH, launched ComboMATCH, a precision medicine initiative for cancer patients. ComboMATCH — short for Combination Therapy Platform Trial with Molecular Analysis for Therapy Choice — uses an individual patient’s tumor biology to determine the appropriate drug combination for treatment. Read Full Article…

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1. The National Cancer Institute (NCI) launched an initiative called ComboMATCH on June 1, 2023. This initiative is designed to use an individual patient's tumor biology to determine the best drug combination for treatment. The need for this initiative was revealed in the NCI-MATCH clinical trial, which showed that patients quickly became resistant to a single drug, suggesting the need for combination therapy​¹​.

2. The NCI will work with various trial groups within the National Clinical Trials Network (NCTN) as part of ComboMATCH. The clinical trials will be diverse in terms of enrollment and the types of drugs used. Some trials will enroll patients with specific cancer types, while others will enroll patients regardless of the kind of cancer they have. Additionally, the drug types will vary, with some trials combining FDA-approved drugs, and others incorporating FDA-approved drugs with investigational drugs​¹​.

3. As of the date of the article, there are already three ComboMATCH trials in progress. These trials include a study testing fulvestrant and binimetinib for patients with an NF1 mutation in hormone receptor-positive breast cancer that has spread, a trial combining selumetinib and olaparib for women with a RAS mutation who have recurrent or persistent endometrial or ovarian cancer, and a trial involving ipatasertib with chemotherapy for patients with solid tumors that have AKT mutations. In addition to these ongoing trials, the NCI plans to conduct six more trials and anticipates further trials as part of the initiative. Furthermore, the NCI aims to launch two other initiatives: ImmunoMATCH and MyeloMATCH, which will evaluate immunotherapy and treatments for acute myeloid leukemia or myelodysplastic syndromes, respectively, using genetic data​¹​.

Google Cloud, Mayo Clinic Strike Generative AI Partnership

By KATIE ADAMS - Amidst a worker shortage, the healthcare industry has been exploring generative AI and its potential to eliminate mundane, burdensome tasks. On Wednesday, two established organizations — Google Cloud and Mayo Clinic — announced a partnership focused on the technology. Read Full Article…

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• Google Cloud and Mayo Clinic have announced a partnership centered around generative AI. The health system will deploy a new HIPAA-compliant Google Cloud service, Gen App Builder, which enables providers to create a search system for their data equipped with conversational features powered by Google’s large language models​1​.

• Gen App Builder is designed to facilitate easier access and interpretation of a vast range of patient data, from clinical guidelines and research papers to electronic health records. The tool is expected to unlock information that is typically difficult to search, including imaging, complex medical histories, labs, and genomics. This capability may lead to faster treatments and increased patient satisfaction​1​.

• This partnership is part of a 10-year collaboration between Mayo Clinic and Google Cloud initiated in 2019. Mayo Clinic will pilot various use cases for Gen App Builder in the coming months, beginning with tasks that alleviate administrative burdens that contribute to clinician burnout. The tool will also be made available to other health systems and is being sold on a SaaS model​1​.

Upperline Health Snags $58M for Its Network of Value-Based Specialty Care Clinics

By KATIE ADAMS - Specialty care is ready for more value-based care models, and investors are helping that transformation move along. Venture funds and angel investors recently funneled $58 million into Upperline Health, a Nashville-based provider network focused on value-based specialty care. Read Full Article…

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1. Upperline Health's Operation and Funding: Upperline Health is a provider network that focuses on value-based specialty care. The company, which recently raised $58 million in funding led by Crestline Investors, targets patients who see specialists four or more times a year and provides them with an interdisciplinary care team that treats them in a clinic, their home, or via phone. The startup's total funding to date amounts to $79 million​1​.

2. Upperline Health's Mission and Care Model: Founded in 2017, Upperline Health aims to improve Americans’ health by providing a "treatment-over-triage approach." The company identifies patients who frequently see specialists and offers them comprehensive care that treats them as whole individuals, not just as a list of diagnoses, demographics, and symptoms. Upperline operates 122 value-based care clinics in seven states, serving 350,000 patients annually. The healthcare workers at these facilities, including physicians, care navigators, pharmacists, social workers, and dieticians, provide complementary services in various settings​1​.

3. Value for Specialists, Primary Care Physicians, and Patients: Upperline Health's care model benefits both specialists and primary care physicians by allowing specialists to broaden their view of the patient and utilize their full training and license. It helps primary care physicians co-manage their sickest patients through additional home visits, 24/7 call services, and care coordination assistance. Patients also derive value from Upperline Health's services as the company meets them where they are and provides them with a personalized navigator and interdisciplinary care team, without necessitating any change in their behavior or provider relationships​1​.

Gag Clauses – New Guidance and Litigation Will Inform Compliance

By Christopher S. Lockman - Certain provisions of the Transparency in Coverage Final Regulations and the Consolidated Appropriation Act, 2021 (“CAA”) require group health plans and/or their vendors to report information to federal agencies. On December 31, 2023, group health plans will have to provide an attestation concerning compliance with the prohibition on gag clauses for the first time. Fully-insured group health plans will be deemed to satisfy the attestation requirement if the health insurance issuer submits an attestation on behalf of the plan. Read Full Article…

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1. Gag Clauses and Compliance Attestation: Certain provisions of the Transparency in Coverage Final Regulations and the Consolidated Appropriation Act, 2021 (“CAA”) require group health plans to report information to federal agencies. This includes an attestation concerning compliance with the prohibition on gag clauses. The first such attestation is due on December 31, 2023. Fully-insured group health plans can meet this requirement if the health insurance issuer submits an attestation on their behalf. However, self-insured group health plans must fulfill this legal requirement even if they have an agreement with a third-party administrator (TPA) to provide the attestation on their behalf​¹​.

2. ACA FAQ Part 57 and the Gag Clause Prohibition: ACA FAQ Part 57, issued by the Departments of Labor, Health and Human Services, and Treasury, provides clarification on the scope of the gag clause prohibition. The FAQ states that a group health plan cannot agree to restrictions in TPA or provider network contracts that would directly or indirectly prevent the plan from accessing and sharing certain cost and quality information. This includes provider-specific cost or quality-of-care information or data, de-identified claims information, and sharing this information with business associates​¹​.

3. Litigation and Disagreements over Gag Clause Prohibition: There are currently disputes playing out in the courts that reflect fundamental disagreements over the interpretation of the gag clause prohibition. For example, in a lawsuit initiated by Trustees of the Int’l Union of Bricklayers and Allied Craftworkers Local 1 Conn. Health Fund against Anthem (Elevance Health), the plaintiffs allege that Anthem breached its fiduciary duties by denying access to claims data and engaging in prohibited transactions. They also allege that Anthem is withholding claims data in violation of the gag clause prohibition. In response, Anthem argues that as a TPA, it is not required to comply with the gag clause prohibition. Another similar dispute is ongoing in Owens & Minor, Inc. et al v. Anthem Health Plans of Virginia, Inc., where the plan sponsor alleges that Anthem breached its fiduciary duty by refusing to provide claims data unless the plan sponsor signed a confidentiality agreement​¹​.

How people with type 2 diabetes may benefit from afternoon exercise

Doctors have long extolled the benefits of exercise to help people with type 2 diabetes (T2D) manage the chronic disease and reduce their risk of health complications. Now, a new study published in the journal Diabetes Care suggests that what time of day those with type 2 diabetes exercise helps determine just how much it benefits them. Read Full Article…

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1. A new study found that people with type 2 diabetes who exercised later in the day achieved better results in terms of blood glucose levels. This was determined by analyzing physical activity data from 2,400 people who were classified as overweight and had been diagnosed with type 2 diabetes. Those who engaged in moderate to vigorous physical activity in the afternoon had the greatest reduction in blood glucose levels after one year and had the highest odds of stopping their glucose-monitoring diabetes medications​¹​.

2. The reasons why afternoon exercise may provide these benefits are not fully understood yet. It is suggested that sleep patterns, diet, and metabolism may play a role. However, further research is needed to determine a more direct link and provide more evidence to prescribe exercise at specific times of day to reduce blood glucose levels​¹​.

3. Despite these promising findings, caution is advised in interpreting the results. Dr. Mitchell Lazar, a physician at the University of Penn Health System, noted that the study did not demonstrate a concrete cause-effect relationship between the time of day a person with type 2 diabetes exercises and reductions in glucose levels. He stressed the importance of considering other confounding factors​¹​. Additionally, a previous study from 2021 found that morning workouts may raise the risk of heart attack in men with type 2 diabetes​¹​.