On June 21, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed notice with comment period outlining a transitional Medicare coverage pathway for emerging technologies through the national coverage determination (“NCD”) process in addition to several guidance documents that describe CMS’ approach to coverage reviews and evidence development, including the National Coverage Analysis Evidence Review and Clinical Endpoints Guidance: Knee Osteoarthritis.Continue Reading CMS Proposes Transitional Medicare Coverage Pathway for Emerging Technologies
The highly anticipated 2024 Medicare Physician Fee Schedule (PFS) was released earlier this month packed with changes that the Administration hopes will advance health equity and expand health service access to underserved populations. Some of the proposed rules emphasize certain Medicare programs like the Biden-Harris Administration’s Cancer Moonshot initiative and the largest accountable care organization (ACO) program, the Medicare Shared Savings Program (MSSP). Additionally, the new rule highlights primary care and contains provisions that align with HHS’ Initiative to Strengthen Primary Care.Continue Reading The 2024 Medicare Physician Fee Schedule Proposed Rule is Here: What you need to know
On July 10, 2023, the Center for Medicare & Medicaid Innovation (CMMI or “Innovation Center”) released a White Paper, Assessing Equity to Drive Health Care Improvements, outlining their analysis and assessment of health equity incorporation in model designs and evaluations. CMMI supports the development and testing of innovative health care payment and service delivery models. These innovation models are designed to improve quality of care and patient outcomes while reducing or maintaining program costs.Continue Reading CMS Innovation Center Reports Data Challenges in Assessing Health Equity
The Centers for Medicare & Medicaid Services (CMS) has recognized that addressing health care disparities and achieving health equity should drive our nation’s top health priorities. According to the CMS Framework for Health Equity 2022-2023, health equity is defined as, “the attainment of the highest level of health for all people, where everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, or other factors that affect access to care and health outcomes”. In order to eliminate health and health care disparities, there needs to be an effort to provide quality, equitable care to those in areas without access and availability to the services necessary to meet their health and social needs.Continue Reading Examining the Use of the Area Deprivation Index in Value-Based Care Models
On June 8, 2023, the Centers for Medicare & Medicaid Services (“CMS”) announced a new Center for Medicare and Medicaid Innovation (“the Innovation Center”) model focused on improving access to primary care and advancing care management and care coordination.Continue Reading CMS Announces New Demonstration Model Focused on Primary Care
On April 4, The Coalition for Health AI (“CHAI”) released the “Blueprint for Trustworthy AI Implementation Guidance and Assurance for Healthcare,” (“CHAI Blueprint”) which addresses the lack of industry-accepted standard governing the development and implementation of artificial intelligence (“AI”) tools in health care, outlines key elements to establish standards on trustworthy AI, issues recommendations for health systems to deploy AI tools in clinical settings, and proposes specifications to be included in a potential assurance standards guide.Continue Reading Coalition for Health AI Introduces Blueprint for Trustworthy AI in Healthcare
The Federal Trade Commission (“FTC”) has taken a number of actions this year against healthcare apps based on data practices that FTC alleges are a violation of federal law. The latest enforcement action, on May 17, 2023, is against Easy Healthcare Corporation (“Easy Healthcare”), which operates the Premom ovulation tracker application (“Premom”), for allegedly violating Section 5 of the FTC Act and the Health Breach Notification Rule (“HBNR”).
The FTC alleges that Easy Healthcare deceived users by disclosing users’ sensitive health data with third parties and failed to notify consumers of these unauthorized disclosures in violation of the HBNR. The proposed order, which was brought by the U.S. Department of Justice on behalf of the FTC, imposes a civil penalty of $100,000 and prohibits Easy Healthcare from sharing user personal health data with third parties for advertising, among other requirements. As part of a related action, Easy Healthcare has agreed to pay an additional $100,000 to Connecticut, the District of Columbia, and Oregon for violating their respective laws.
The latest enforcement action against Premom follows recent FTC actions against GoodRx Holdings, Inc. for violating Section 5 of the FTC Act and the HBNR and BetterHelp, Inc. for violating Section 5 of the FTC Act, which appears to be part of a larger effort by the FTC to monitor the practices of websites, apps, and connected devices that capture consumer’s sensitive health information. The action also signals the FTC’s spotlight on companies’ use of reproductive health data, particularly in menstrual cycle and fertility applications, in the wake of the Dobbs v. Jackson Women’s Health Organization (“Dobbs”) decision.
Digital health companies and other organizations across the health care industry should take note of the trend of enforcement actions and evaluate their business policies and practices.
For more detailed information, see FTC Announces Enforcement Action Against Ovulation Tracking App Premom.
On May 2, FDA published a draft guidance on decentralized clinical trials (DCTs) to provide recommendations for sponsors, investigators and others on implementation of DCTs, as required by the Food and Drug Omnibus Reform Act (FDORA).
DCTs include both fully decentralized trials – where all trial activities take place at locations other than trial sites – and hybrid trials – where some trial activities take place outside the traditional site. These alternative sites can include a primary care provider’s office, a local laboratory, or a participant’s home.
DCTs hold promise to increase enrollment in trials, particularly by people in demographics not commonly enrolled in trials. FDA recognized that DCTs have “the potential to expand access to more diverse patient populations,” such as people who don’t live near an academic medical center, or have limited mobility. It continues, “By enabling remote participation, DCTs may enhance convenience for trial participants, reduce the burden on caregivers, and facilitate research on rare diseases and diseases affecting populations with limited mobility or access to traditional trial sites. This may help improve trial participant engagement, recruitment, enrollment, and retention of a meaningfully diverse clinical population.”
Comparison with current regulations: FDA made clear, in the guidance, that the same regulations that govern traditional clinical trials (for drugs and devices) also govern DCTs. This includes a physical location for all records, adverse event reporting, IDE application (as necessary), relevant licensing laws, IRB oversight and more.
Reducing variability: The guidance recommends the use of a designated clinical laboratory to reduce variability in results such as blood levels and radiological scans.
Data management plan: The FDA encouraged the establishment of a data management plan (DMP). A DMP, in this context, is a way for the sponsor to account for multiple sources of data collection. DMPs should include information about the “methods used for remote data acquisition” and transmission of data. Data provenance is also mentioned. Later, the guidance recommends quality control measures to reduce variability of data.
Routine care and trial participation: A remaining concern regarding the difference between local health care providers involvement in DCTs and routine care is partially addressed in this guidance. The FDA states that providers who are doing routine care do not need to be listed on the FDA forms as part of the trial; however, this does not address any billing questions regarding these services.
Informed consent and IRBs: Like centralized clinical trials, informed consent and IRB oversight is a requirement of DCTs. The guidance recognizes that informed consent may be obtained remotely. DCT informed consent should include, in addition to the elements required for traditional clinical trials, information about who will have access to personal health information. FDA recommends the use of a central IRB.
Safety and other considerations: FDA also considers what types of products are well-suited for DCTs, particularly where the investigational product is being remotely administered. The guidance recommends that when the safety profile of the investigational product is well-established and there is little risk of immediate adverse events, remote administration of the product may be acceptable. Some products will be well-suited for self-administration, particularly those who not only meet the above characteristics but also are shelf-stable under normal storage conditions. Packaging and distribution of these products is addressed in the guidance.
Safety monitoring: As with all trials, a safety monitoring plan is required. DCTs have an additional layer of complexity around monitoring safety, which must be addressed in the plan.
Software and DCT: Software and digital health tools used in DCTs are addressed in this guidance. The guidance recommends that sponsors consider a number of factors when selecting these tools, including ensuring that the technologies are suitable for use by all trial participants, that the tools are valid, and meet the recommendations in previous guidances. FDA considers the use of electronic records in DCTs, but allows for remote providers to upload forms or documents securely, rather than directly entering data into the case report forms.
Telehealth: FDA notes that live video or audio interactions are not part of the electronic record and not subject to FDA regulations around electronic records for trials. Privacy and security of these interactions must be protected, and local telehealth laws apply. If these interactions are captured for the record, they must comply with Part 11 requirements.
While this is non-binding guidance, entities involved in DCTs or support of DCTs should review this guidance as it provides direction by the FDA in addressing issues raised by DCT. Among the more interesting issues is the position regarding data management plans and consideration for products that may be conducive to DCTs.
FDA is accepting comments on this draft guidance for 90 days after publication in the federal register on May 3.
 The type and scope of quality control measures should be tailored to the criticality of the data and the complexity of procedures done by the local HCPs.
 Local HCPs contracted to provide trial-related services that are part of routine clinical practice (e.g., performing physical examinations, reading radiographs, obtaining vital signs) and where a detailed knowledge of the protocol, IP, and the investigator’s brochure is not necessary should not be listed on Form FDA 1572 as subinvestigators. However, local HCPs should be included in a task log (as described below in this section).
[*] IP, and the investigator’s brochure is not necessary should not be listed on Form FDA 1572 as subinvestigators. However, local HCPs should be included in a task log (as described below in this section).
In 2021, 1 in 10 American households experienced food insecurity, an issue exacerbated by the COVID-19 pandemic. Diet-related diseases such as diabetes, heart disease, and cancer are some of the leading causes of death and disability in the U.S. Each year in the U.S. there is an estimated $52.8 billion in excess health care costs as a result of adults experiencing food insecurity. Since recognizing the influence of nonmedical factors such as socioeconomic status, education, and physical education on health, there have been a growing number of initiatives to address social determinants of health (SDOH) within the health care system. Food is medicine interventions are tailored to respond to the connection between food and health in order to help prevent, manage, or reverse diet-related disease. Food is medicine interventions may include medically tailored meals, produce prescriptions, and medically tailored food packages. These interventions have been associated with decreased inpatient hospital admissions, decreased overall healthcare costs, increased medication adherence, and increased diet quality. The concept of using healthy foods to reduce diet-related disease in the U.S. is increasing in popularity. There is bipartisan support for food is medicine initiatives to target food insecure and medically vulnerable populations.Continue Reading Food is Medicine: Can Policymakers Come to the Table?
Rapid developments and competition in artificial intelligence (AI) will drive proliferation of new AI technologies in health care in the coming years, along with a number of legal and ethical issues.
ChatGPT 3.5 created a huge splash, rife with controversy, when it was released in November 2022. Launched by the San Francisco-based startup OpenAI, ChatGPT is a natural language processing (NLP) model (a type of machine learning (ML)), that automatically learns and recognizes patterns. ChatGPT uses a neural network architecture to generate human-sounding responses to questions, providing users with large amounts of potentially useful information in seconds. According to a recent review, ChatGPT demonstrated that it was capable of passing all three parts of the U.S. Medical Licensing Exam (USMLE), which tests medical students on topics including the basic sciences, clinical knowledge and patient treatment and diagnosis, without any specialized training. ChatGPT also showed proficiency in medical charting, diagnosing, and performing nonclinical tasks. OpenAI recently launched ChatGPT 4.0, which offers expanded capabilities and improved performance on various professional and academic assessments.Continue Reading AI in Health Care: AI Bill of Rights, Future Regulations, and What Business Should Consider Now