Tuesday, July 16, 2024

Regulatory Considerations for Enhancing Medical Device Study Recruitment

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Regulatory challenges significantly impact the recruitment and retention of study subjects for medical device companies that are innovating and sponsoring clinical trials, particularly when designing studies that reflect the diversity of the national population. Difficulties enrolling eligible study subjects can lead to significant study delays and can be costly for trial sponsors, extending the timeline that patients need to wait to obtain access to safe, effective, and important medical technologies.

Research has shown that more than 80% of clinical trials face delays related to the recruitment of study subjects, and a 2023 report from the American Center for Cancer Research found that as many as 20% of clinical trials fail due to insufficient patient enrollment. While many factors can adversely impact recruitment efforts, including complex trial designs and narrow eligibility criteria, a recent literature review conducted by the National Institutes of Health found that study burden — costs associated with participating in a clinical trial, such as transportation, childcare, and time away from work — is the most commonly cited barrier to participation.

Regulatory Push for Diversity: Federal Agencies and Industry Call for Inclusive Clinical Trial Enrollment

At the same time, federal regulatory agencies and industry participants have called for increased diversity in clinical trial enrollment, including implementing new regulatory requirements aimed at ensuring that sponsors take appropriate steps to enroll patients from diverse backgrounds in their trials.

For example, in April 2022, the Centers for Medicare and Medicaid Services (CMS) limited coverage for a class of drugs indicated to treat Alzheimer’s disease to clinical trials in which the diversity of the study population represented the national population with similar clinical diagnoses. During that same month, the Food and Drug Administration (FDA) issued draft guidance to industry for developing plans to enroll more trial participants from underrepresented racial and ethnic groups. Most recently, in December 2022, Congress enacted the Food and Drug Omnibus Reform Act of 2022 (FDORA), which requires most clinical trial sponsors to submit diversity action plans to FDA.

In addition, the Advanced Medical Technology Association (AdvaMed), a trade association for medical device manufacturers, has also highlighted the need for increased diversity in clinical research within the medtech industry to address health inequities and launched the Responding To Racial Disparities In Health initiative in 2020, which sets out four principles on health equity, including one specifically focused on promoting research equity.

Despite the growing awareness of the importance of diversity in clinical research and how achieving diversity can reduce health disparities and improve health equity, sponsors continue to encounter significant barriers to recruiting diverse study subjects, due in meaningful part to financial barriers.

To address these financial barriers, many device trial sponsors are, or are considering, providing various types of financial support to potential study subjects to encourage them to enroll, and remain enrolled, in their clinical trials. While providing financial support to potential study subjects can be a valuable tool for recruitment, it can also pose heightened risks under the US healthcare fraud and abuse laws.


Regulatory Compliance in Clinical Trials: Financial Support and US Healthcare Fraud and Abuse Laws

Providing financial support can be an effective tool to improve recruitment and retention of study subjects, including those from diverse backgrounds. However, clinical trial sponsors must be mindful of a myriad of US healthcare fraud and abuse laws when offering such support. These laws principally include the federal Anti-Kickback Statute (AKS), the federal Beneficiary Inducement Statute (BIS), and the federal False Claims Act (FCA).

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The Anti-Kickback Statute (AKS) is a criminal law that prohibits the offer or receipt of remuneration to induce referrals for items or services payable by a federal healthcare program, unless the arrangement fits within a statutory exception or regulatory safe harbor. In the context of clinical trials, the AKS could be implicated if the study device is covered and reimbursed by Medicare, or if the manufacturer markets other devices covered by federal healthcare programs.

The Beneficiary Inducement Statute (BIS) prohibits providing free or discounted items or services to Medicare or Medicaid beneficiaries to influence their choice of provider, practitioner, or supplier. While medical device manufacturers might not be directly liable, they should avoid aiding or abetting violations by study investigators or sites.

The False Claims Act (FCA) imposes liability on those who knowingly submit false claims for payment to the federal government. Violations of the AKS and BIS can form the basis of FCA claims, leading to significant penalties. Therefore, clinical trial sponsors must carefully navigate these laws to ensure compliance and avoid substantial legal and financial repercussions. The US Department of Health and Human Services, Office of Inspector General (OIG), the agency tasked with enforcing the AKS and BIS, has issued favorable advisory opinions approving financial support arrangements under specific circumstances. These opinions focus on three principles:

Financial support should be a reasonable means of promoting enrollment, particularly for diverse backgrounds, by removing financial barriers to participation. It should not incentivize unnecessary use of items and services, thereby avoiding increased federal healthcare program costs. Additionally, financial support should not be used to lock in future utilization of reimbursable items or services outside the clinical trial context.

To navigate these complexities, medical device companies should ensure financial support is reasonably tied to facilitating enrollment and retention, document the rationale for financial support internally and review it through legal or compliance departments, avoid advertising cost-sharing subsidies to study subjects, ensure legal review of all recruitment materials, and educate clinical trial personnel on healthcare fraud and abuse risks.

Recruiting and retaining diverse study subjects in medical device trials is critical for innovation and equity in healthcare. While financial incentives can be effective, they must be carefully managed to comply with US healthcare fraud and abuse laws. By following regulatory guidance and adopting practical strategies, sponsors can enhance recruitment efforts while minimizing legal risks.


Resource: Medical Device and Diagnostic Industry, July 05, 2024

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