Research fashions financial influence of proposed regulation to control high-risk diagnostic exams

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Study models economic impact of proposed law to regulate high-risk diagnostic tests

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The legislation currently under consideration at the U.S. Congress would increase oversight of certain diagnostic tests, and a new study by researchers at Massachusetts General Hospital (MGH) and colleagues from several other institutions shows that their potential effects depend on the key details in the final Bill will depend on language. This study, published in JCO Oncology Practice, provides the first evidence-based analysis of how new rules for regulating laboratory-developed tests (LDTs) could affect healthcare costs in the United States.

"The idea of ​​having more control over LDTs ​​is justified," says Dr. Jochen Lennerz, Medical Director of the MGH Center for Integrated Diagnostics (CID) and lead author of the study. "However, our results show that it is very important to align the language in this new law with the intent of what is to be achieved with it."

From a regulatory perspective, there are two categories of in vitro clinical tests (IVCTs), including diagnostic tests performed in a test tube, culture dish, or other location outside of a living organism. Prepared tests for a wide variety of conditions are commercially available. The Food and Drug Administration (FDA) strictly regulates these tests and requires manufacturers to submit marketing approval data before they can be sold. However, clinical laboratories in hospitals and other health care facilities can create their own IVCTs for in-house use called LDTs. Currently, the FDA does not require LDTs ​​to be marketed and has little control over their use.

LDTs serve a variety of purposes, but a critical role is to identify patients for novel drug therapies that target specific DNA variations, especially when a commercial test is not yet available. This form of therapy, known as personalized medicine, is becoming increasingly important in cancer treatment.

Unfortunately, flawed IVCTs can lead to inaccurate results, leading some patients to forego potentially beneficial treatments and receive others from unnecessary and potentially harmful therapies. The proposed legislation, currently known as the Verifying Accurate and Leading-Edge IVCT Development (VALID) Act, illustrates the authority of the FDA over all diagnostic testing.

If passed, VALID would focus on what are known as highly complex IVCTs, which have the greatest potential for patient harm if the results are incorrect. To comply with VALID, clinical laboratories would need to demonstrate the accuracy of their LDTs, including a process known as technology certification.

Lennerz believes that the strict interpretation of VALID, which is not currently defined in the bill, will have an impact on whether the proposed bill can improve the quality of LDTs ​​without significantly increasing future health care costs. He joined lead author Richard Huang, MD, and several colleagues to model the total cost of maintaining the framework for technology certification under VALID for cancer diagnostics. They based their estimates on 2019 data from CID, which performs more than 10,000 highly complex LDTs ​​for MGH patients each year.

The study found that the maintenance cost for a lab performing this volume of LDT would be $ 638,000 per year with low stringency and slightly higher ($ 685,000) with moderate stringency, but to $ 1.2 million with very strict enforcement would rise. Extrapolating this data to reflect the additional cost of the country's 886 cancer treatment centers and ensuring VALID compliance would reduce U.S. healthcare costs by $ 565 million, $ 606 million, or $ 1.1 billion over a three-year period . USD increase depending on strict enforcement.

Lennerz believes the study's important contribution is to put a price tag on VALID, which no one has done before. "The most important finding is that there is a cost to maintain this new infrastructure," he says.

And while those numbers may seem high to some, they should be kept in mind, says study co-author Jeff Allen, president and CEO of Friends of Cancer Research, a nonprofit patient advocacy organization in Washington, DC: "In the US, We're consistently seeing increases in healthcare spending in the region of $ 200 billion a year. "Even with additional FDA enforcement, VALID's increased cost is less than 0.5% of its annual increase in spending, he notes firmly. "With the gain in assured quality in tests, the avoidance of medical errors and the improved support in medical decision-making, the costs will be offset. Most importantly, patient care will improve," says Allen. VALID has bipartisan support in both houses of Congress, which is expected to begin debating the law in early summer.

Testing the accuracy of FDA-approved and laboratory-developed cancer genetics tests

More information:
Richard Huang et al., National Precision Diagnostic Maintenance Costs under the 2020 In Vitro Clinical Test (VALID) Accurate Development Review Act, JCO Oncology Practice (2021). DOI: 10.1200 / OP.20.00862

Provided by
Massachusetts General Hospital

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