Policies that Could Reduce the Data Collection Burden on Healthcare Providers
@DukeMargolis
nnovations in medical technology have led to a proliferation of transformative therapies that promise to alter treatment paradigms and even reverse disease progression. The promise of treatment outcomes can make these technologies eligible for expedited regulatory pathways that do not require extensive clinical trial data for market approval.
Stakeholders Involved in Evidence Generation
Payers have been instrumental in motivating data collection through requirements for reimbursement, quality metrics, specialty certification, site accreditations, among others. The most notable US example requiring data collection for reimbursement is Medicare’s Coverage with Evidence Development (CED), a paradigm in which novel therapies are granted national Medicare coverage with the condition that outcomes data is captured in a national clinical registry, thus allowing patients to benefit from promising interventions that warrant additional evidence. By promoting continued evidence development under real-world settings, it helps to address questions that are not answered through clinical trials, such as long-term outcomes and effectiveness, durability of the therapy, and collecting clinical evidence across subgroups of patients or indications. Medicare has used CED since 2006 and found it to be instrumental in facilitating the adoption of novel therapies. The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry (TVT Registry) is an example of a registry that is managed by specialty societies and has been used to satisfy Medicare CED requirements as well as FDA’s PMS requirements for novel cardiac valve therapies. Data from this registry has also been used in regulatory submissions for label expansions and informing clinical practice guidelines.
The single national registry model, such as the TVT Registry and other CED registries, have several advantages that include:
- enabling direct comparison across all technologies in the same therapeutic category;
- facilitating analyses of patients treated by different subgroups and provider types;
- studying durability and long-term effects on a predictable timeline across all patients and subgroups; and
- developing benchmarks for quality of care and outcomes.
There are, however, many limitations in these registries, stemming from their model of prospective clinical studies. These include high costs to participate and maintain, administrative burdens of multiple reporting requirements, and operational limitations in data access. These challenges can discourage healthcare providers from enrolling in the registry and, thus, offering the therapies. On the other hand, Medicare requirements for data collection for reimbursement as well as other payer requirements establish a strong motivation for healthcare providers to remain engaged.
Improved data collection, curation, and analysis methods can mitigate these challenges and lessen the burden on healthcare providers. Data collection that builds on advanced data systems RWE are less costly and can effectively complement prospective clinical registry models. These systems are based on an infrastructure of automated, near real-time data collection that allow for faster data analyses, allowing stakeholders to make faster evidence-based decisions.
Policy Recommendations to Improve Evidence Generation
CMS as well as other payers can expand their payment reforms both on the provider and care delivery levels. In 2019, there were 1,588 existing public and private accountable care organizations participating in both Medicare’s Shared Savings Program and other provider payment reforms that have quality and performance metrics that healthcare providers need to report. As these models already require layers of data reporting, one opportunity to ensure continued evidence generation for new technologies is to align their performance measures with larger care delivery and provider performance measures. This alignment will ensure the data being collected for new technologies have synergies with other reporting requirements. Simplifying and standardizing performance measurement reporting by aligning on outcome measures can reduce redundancies and administrative burden for the provider.
Finally, payers can undertake regular reviews of evidence generation priorities and criteria to inform what evidence should be collected that can yield more value. This change could entail working alongside other stakeholders and forming public-private partnerships to agree upon the most important evidence questions, streamline data collection forms, and ease the implementation by sharing best practices and a formal evaluation plan.