How New Legislation Could Fast-Track Medicare Coverage for Breakthrough Devices and Treatments
Learn how proposed legislation could affect reimbursement for Medicare beneficiaries.
Lawmakers have introduced legislation to increase access to breakthrough medical devices and expand Medicare coverage for weight loss treatments and medications.
The Critical Breakthrough Products Act would hasten approval and reimbursement for groundbreaking medical devices, enabling them to reach patients more quickly. And it would integrate with other legislation to improve the accessibility of obesity-related treatments.
These potential new laws could drastically impact payers' reimbursement strategies and necessitate adjustments to accommodate faster approval and claims processing. This article delves into the implications so payers can prepare for the possible changes.
Key Takeaways
What's the Act's Primary Goal?
The Critical Breakthrough Products Act aims to speed up patient access to life-saving treatments by connecting the U.S. Food & Drug Administration's (FDA) approval with Medicare coverage, thereby streamlining approval and reimbursement processes.
Once the FDA designates a device as a breakthrough product, it would automatically qualify for Medicare coverage, expediting the time it takes for devices to become available to patients.
For context, it currently takes an average of three to seven years to bring a device to market and an average of twelve years for drugs. So, by closely linking FDA approval with Medicare reimbursement, the Act aims to remove the significant barriers that delay access to advanced medical devices.
Legislative Journey
Recently, the House Ways and Means Committee approved the Act—a major bipartisan step that shows great promise for its progress toward becoming a law.
This legislation, officially known as the H.R. 1691—Ensuring Patient Access to Critical Breakthrough Products Act of 2023, was introduced by Rep. Dr. Brad Wenstrup, R-Ohio. To stay updated on its progress, you can sign up for alerts on Congress.gov.
Bridging the Gap with Temporary Medicare Coverage
The proposed legislation also includes temporary coverage for innovative medical products, providing patients with a safety net of support.
This provision means that, under the Act, breakthrough devices would receive temporary Medicare coverage for a minimum of four years following FDA approval, allowing patients to benefit from the latest innovations in medical technology while additional clinical data is gathered to support long-term coverage decisions.
Furthermore, after four years, the Centers for Medicare & Medicaid Services (CMS) would be required to establish a process for continued coverage based on additional evidence collected during the temporary coverage period to ensure uninterrupted patient benefit from these innovations.
Medical Billing and Coding
Regarding medical billing and coding, CMS would be required to assign payment codes for breakthrough devices within three months of FDA approval to facilitate quicker reimbursement.
Integration with the Reduce Obesity Act
Lawmakers are pushing to integrate the Critical Breakthrough Products Act with another introduced bill—the Reduce Obesity Act—to effectively unite forces to make obesity-related treatments more accessible.
The Treat and Reduce Obesity Act of 2021 proposes adding Medicare Part D coverage for anti-obesity medications for individuals entering Medicare and reevaluating the National Coverage Determination (NCD) of Intensive Behavioral Therapy for Obesity to include diet and exercise treatments for seniors. Senator Thomas R. Carper, D-Delaware, introduced the bill.
Combining the strengths of both bills would streamline approvals for obesity-reducing therapies, expediting patients' access to treatment.
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What Are the Cost Implications?
If the Act becomes law, transitional coverage for breakthrough devices may increase Medicare system costs in the short term. However, it is designed to decrease long-term healthcare expenses by enhancing patient outcomes and lowering chronic disease management costs.
Coverage for Chronic Diseases
Breakthrough devices can offer significant advantages over existing treatments for managing chronic diseases like diabetes and cancer, and the Act aims to provide Medicare coverage for such devices.
Additionally, the Act could lower long-term healthcare expenses by facilitating earlier coverage of these devices, reducing the costs associated with managing untreated chronic conditions, filling current policy gaps, and removing barriers to effective treatments for seniors.
How CMS Plans to Speed Up Coverage
For devices on the Transitional Coverage for Emerging Technologies (TCET) pathway, CMS aims to finalize an NCD within six months following FDA approval, expediting the coverage process for breakthrough devices.
Additionally, CMS will review nominations for the TCET pathway every quarter to ensure that the most promising devices receive timely coverage.
How Can Payers Prepare for These Changes?
Although the legislation has yet to be passed, payers should be vigilant in staying informed about potential changes that could affect devices, products, and treatments eligible for reimbursement.
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Summary
The Critical Breakthrough Products Act is legislation that would accelerate patient access to innovative medical devices and treatments by linking FDA approval with Medicare coverage.
This Act and related bills seek to streamline the approval and reimbursement processes for breakthrough medical products and obesity-related treatments. ?
Key provisions include expedited Medicare coverage for FDA-approved devices, temporary coverage for new medical technologies, and integration with other legislation to enhance access to obesity treatments.
These changes could impact payer reimbursement strategies and require adjustments to accommodate faster approval and claims processes. The article explored these implications, urging payers to proactively prepare for potential legislative shifts by adopting advanced technological solutions for claims reviews and reimbursement management.