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if(isHidden(s)){ s.style.display = 'inline'; } else { s.style.display = 'none'; } } function isHidden(element){ var style = window.getComputedStyle(element); return (style.display === 'none'); } </script> <span class="cc_sidebar"> <span class="cc_color_bar"> <span class="cc_home_icon"> <a href="https://www.thermofisher.com/blog/clinical-conversations/"><img src="https://www.thermofisher.com/blog/clinical-conversations/wp-content/themes/clinical-conversations/images/icon_home.png" alt="Clinical Conversation blog - home icon" /></a> </span> <span class="cc_post_category"> <a class='cc_colorbar_category' href='https://www.thermofisher.com/blog/clinical-conversations/category/science-and-education/'>Science and education</a> </span>  <span id="cc_post_readtime"> 9 mins. </span> <span class="cc_toggle_social"> <a href="javascript:cc_toggle('cc_jetpack_shares');">Sharing ▼</a> </span> <span class="cc_toggle"> <a href="javascript:cc_toggle('cc_metadata');">Details ▼</a> </span> </span> </span> <span id="cc_jetpack_shares"> <ul> <li><a target="_blank" href='https://www.linkedin.com/shareArticle?mini=true&url=https%3A%2F%2Fwww.thermofisher.com%2Fblog%2Fclinical-conversations%2Fpharmacogenomics-testings-evolving-landscape-regulatory-changes-reimbursement-challenges-and-legislative-advances%2F&title=Pharmacogenomics+Testing%E2%80%99s+Evolving+Landscape%3A+Regulatory+Changes%2C+Reimbursement+Challenges%2C+and+Legislative+Advances'><img src="https://www.thermofisher.com/blog/clinical-conversations//wp-content/themes/clinical-conversations/images/social_icons_linkedin.jpg" alt="Linked In sharing icon" /></a></li> <li><a target="_blank" href='https://www.facebook.com/sharer/sharer.php?u=https%3A%2F%2Fwww.thermofisher.com%2Fblog%2Fclinical-conversations%2Fpharmacogenomics-testings-evolving-landscape-regulatory-changes-reimbursement-challenges-and-legislative-advances%2F'><img src="https://www.thermofisher.com/blog/clinical-conversations//wp-content/themes/clinical-conversations/images/social_icons_facebook.jpg" alt="Facebook sharing icon" /></a></li> <li><a target="_blank" href='https://twitter.com/intent/tweet?text=Pharmacogenomics+Testing%E2%80%99s+Evolving+Landscape%3A+Regulatory+Changes%2C+Reimbursement+Challenges%2C+and+Legislative+Advances&url=https%3A%2F%2Fwww.thermofisher.com%2Fblog%2Fclinical-conversations%2Fpharmacogenomics-testings-evolving-landscape-regulatory-changes-reimbursement-challenges-and-legislative-advances%2F&'><img src="https://www.thermofisher.com/blog/clinical-conversations//wp-content/themes/clinical-conversations/images/social_icons_twitter.jpg" alt="Twitter sharing icon" /></a></li> <li><a href='mailto:?subject=You might be interested in Pharmacogenomics Testing’s Evolving Landscape: Regulatory Changes, Reimbursement Challenges, and Legislative Advances from the Clinical Conversations blog.&body=You might be interested in Pharmacogenomics Testing’s Evolving Landscape: Regulatory Changes, Reimbursement Challenges, and Legislative Advances from the Clinical Conversations blog at https%3A%2F%2Fwww.thermofisher.com%2Fblog%2Fclinical-conversations%2Fpharmacogenomics-testings-evolving-landscape-regulatory-changes-reimbursement-challenges-and-legislative-advances%2F'><img src="https://www.thermofisher.com/blog/clinical-conversations/wp-content/themes/clinical-conversations/images/icon_email.png" alt="Email sharing icon" /></a></li> </ul> </span> <span id="cc_metadata"> <span class="cc_dateline"> <span class="post-info-date">  29 Aug 2024 </span> || <span class="post-info-author">   By Dr. Becky Winslow, PharmD. </span> </span> <span class="cc_shares"> <span class="cc_shares_subhead" >Shares: <span class="share_count">2</span> </span> </span> <span class="cc_version"> <span class="cc_version_subhead">Versions of this article</span> Original article. </span> <span class="cc_post_tags"> <span class="cc_post_tags_subhead">Tags</span> <a href='https://www.thermofisher.com/blog/clinical-conversations/tag/pgx/'>PGx</a> </span>   </span> <script type="text/javascript"> cc_toggle('cc_metadata'); cc_toggle('cc_jetpack_shares'); </script> </header><div class="entry-content"><p>Pharmacogenomics (PGx), the study of how genes affect a person’s response to drugs, is a rapidly evolving field. Recent developments in regulatory oversight, reimbursement policies, and legislative actions have brought new challenges and opportunities for pharmacogenomics stakeholders.</p> <ol> <li><strong>FDA Publishes Final Rule on Laboratory-Developed Test (LDT) Regulation</strong></li> </ol> <p>On April 29, 2024, the U.S. Food and Drug Administration (FDA) announced its final rule to begin actively regulating all laboratory-developed tests (LDTs), including PGx tests, as medical devices. Most PGx tests available in the U.S. today are non-FDA-approved LDTs. LDTs are in vitro diagnostic products (IVDs) that the FDA intends for clinical use and for use only in the single Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified high- complexity-testing laboratory that designed and manufactured it. The FDA’s final rule amends the FDA’s regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including when the IVD’s manufacturer is a laboratory. Before this final rule, the FDA only maintained oversight over LDTs, while the Centers for Medicare and Medicaid’s (CMS) Clinical Laboratory Improvement Amendments (CLIA) program has regulated non-FDA-approved LDTs to ensure they are accurate and safe for patients.</p> <p><img decoding="async" class="size-full wp-image-17237 aligncenter" src="https://www.thermofisher.com/blog/clinical-conversations/wp-content/uploads/sites/18/2024/08/PGx_011224_1200x675.jpg" alt="" width="1200" height="675" srcset="https://www.thermofisher.com/blog/clinical-conversations/wp-content/uploads/sites/18/2024/08/PGx_011224_1200x675.jpg 1200w, https://www.thermofisher.com/blog/clinical-conversations/wp-content/uploads/sites/18/2024/08/PGx_011224_1200x675-300x169.jpg 300w, https://www.thermofisher.com/blog/clinical-conversations/wp-content/uploads/sites/18/2024/08/PGx_011224_1200x675-1024x576.jpg 1024w, https://www.thermofisher.com/blog/clinical-conversations/wp-content/uploads/sites/18/2024/08/PGx_011224_1200x675-768x432.jpg 768w" sizes="(max-width: 1200px) 100vw, 1200px" /></p> <p>CLIA intends its analytical validity assessment to determine if a specific test finds what it is supposed to find, i.e., the analyte the lab test intends to detect performing the test on patient specimens. Therefore, the laboratory intending to use the test on patient specimens must perform the analytical validation. An example PGx test analyte is the CYP2C19 gene. CLIA only validates a PGx test’s analytical validity or ability to measure the genotypes it says it can measure accurately and reliably. Analytical validity or accuracy is not the same as clinical validity, a PGx test’s ability to accurately predict the presence or absence of a pharmaco- phenotype, and clinical utility, a test’s ability to provide information that is useful in making decisions about prevention or treatment strategies. A PGx test can be analytically valid and not clinically valid nor able to positively impact medication outcomes.</p> <p>While CMS’ CLIA program does not address a test’s clinical validity, the FDA includes an analytical and clinical validity assessment in the test system’s premarket review. Laboratories must undergo a rigorous and complex process to earn FDA approval or clearance for their laboratory-developed PGx tests. It involves several steps:</p> <ul> <li><strong>Development and Validation</strong>: Laboratories must first develop the test and validate its performance characteristics (analytical validity), such as accuracy, precision, analytical sensitivity, and specificity.</li> <li><strong>Regulatory Submission</strong>: Laboratories must then submit a premarket approval application or a 510(k) submission to the FDA, including evidence of the test’s clinical validity and utility.</li> <li><strong>FDA Review</strong>: The FDA reviews the submission, assessing the test’s analytical and clinical performance and the laboratory’s compliance with quality system regulations.</li> <li><strong>Post-Market Surveillance</strong>: Once the test is on the market, the laboratory must monitor its performance, report any problems, and take corrective actions if necessary.</li> </ul> <p>The FDA’s move, while sparking controversy, holds the potential to enhance the safety and effectiveness of LDTs significantly. However, negative impacts are also possible, as stakeholders expect with any significant changes to safety and efficacy assessment systems. These could include decreased patient access to valid and utile PGx tests, increased PGx test costs, and decreased PGx test innovation. For example, when new gene variants develop robust evidence to support their inclusion in a PGx test for a particular gene, the laboratory would have to resubmit their test with the additional gene variant through the FDA’s approval or clearance process.</p> <p>Thus, FDA-approved PGx tests available for clinical use may only include some clinically significant pharmacogene variants if the FDA approved the test before research revealed the variants’ validity and utility.</p> <ol start="2"> <li><strong>California PGx Test Payer Coverage and Reimbursement, Medi-Cal and Medicare</strong></li> </ol> <p>While many states have passed legislation to require payers to cover comprehensive biomarker testing for cancer, in 2023, the California State Legislature passed AB 425 Medi-Cal Pharmacogenomics (PGx) Testing into law to establish, specifically, PGx testing coverage for Medi-Cal beneficiaries whose physicians have prescribed for them or who are already taking medications with Clinical Pharmacogenetics Implementation Consortium (CPIC) or FDA identified evidence-based PGx interactions. The bill also allows specimen collection setting flexibility (e.g., at-home, pharmacy, or health facility) increases the likelihood that PGx tests are analytically valid by requiring the laboratory to be CA-licensed and Centers for Medicare and Medicaid (CMS)-approved accreditation body accredited such as the College of American Pathologists (CAP) or the Joint Commission (TJC) accredited; ensures the PGx test is affordable; and ensures prior authorization processes do not hinder access to the test.</p> <p>The law slated Medi-Cal coverage to start on July 1, 2024, and despite the California Department of Health Care Services requesting to delay coverage implementation secondary to budget constraints, the June 2024-25 C.A. state budget provides $6.5 million to implement AB 425.</p> <p>Many payers are now turning to Palmetto GBA’s MolDX program to make decisions about coverage and reimbursement for molecular pathology testing, including PGx testing. Palmetto GBA is a company that provides administrative and information technology services for both government and commercial customers. They serve as a Medicare Administrative Contractor (MAC) handling Medicare Part A and B claims for several states, including California, and Part B claims for Railroad Retirement beneficiaries nationwide.</p> <p>Palmetto GBA developed the MolDx program in 2011 to identify and establish coverage and reimbursement for molecular diagnostics tests. Laboratories located in the MolDX territory who desire MolDx to reimburse their PGx tests must submit a technical assessment to MolDX robustly proving their tests’ analytical and clinical validities. MolDx only deems clinically useful for reference the Clinical Pharmacogenetics Implementation Consortium’s Level A and B drug- gene pairs. Palmetto GBA assigns unique DEX Z-Code® Identifiers to molecular diagnostic (MDx) tests and catalogs them in the test identification and policy management solution, the DEX® Diagnostics Exchange. The exchange aims to connect payers and labs to clarify MDx testing. Several payers defer to MolDx’s expert technical assessment reviewers to determine their coverage and reimbursement for testing. The test registry catalog is also available for reference and review by other stakeholders in the healthcare system.</p> <p>In brief, while labs have succeeded in securing broader and deeper payer funding for PGx testing in the last five years, payer reimbursement for PGx testing remains an issue.</p> <ol start="3"> <li><strong>National Action Plan for Adverse Drug Event Prevention and the Right Drug Dose Act</strong></li> </ol> <p>An Adverse Drug Event (ADE) is the damage a medication causes an individual. Despite up to half of ADEs being avoidable, they persist as a significant threat to public health and a substantial economic burden. Every year, ADEs are responsible for 1.3 million visits to the emergency department and 350,000 hospital admissions, and they rank as the fourth most common cause of fatalities in the United States. The country records 4.5 million ADEs annually, leading to healthcare expenses worth $2.5 billion. As the need to prevent ADEs has become more dire, there is increased interest in minimizing patient risks.</p> <p>In 2014, the United States Department of Health and Human Services (USDHHS) established the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan) to address two key objectives: (1) identify common, preventable, and measurable adverse drug events (ADEs) that may result in significant patient harm; and (2) align Federal health agencies’ efforts to reduce patient harms from these specific ADEs nationally. While the ADE Action Plan has made significant progress toward reducing ADEs due to the Plan’s initial drug targets (i.e., anticoagulants, diabetes agents, and opioids), stakeholders recognize the USDHHS needs to retool ADE prevention efforts to include additional and newly emerging medication safety targets.</p> <p>The Right Drug Dose Act of 2024, bipartisan legislation introduced by U.S. Representatives Eric Swalwell (CA-14) and Dan Crenshaw (TX-02), aims to update the 2014 National Action Plan in several ways to reduce adverse drug event occurrences and improve patient outcomes through personalized medicine.</p> <ol> <li><strong>Pharmacogenomic Research and Testing Advances Consideration</strong>: The Act aims to update the National Action Plan for Adverse Drug Event Prevention by integrating pharmacogenomic research and testing advancements. The Act considers advances in scientific understanding and technology about drug-gene interactions (including interactions among multiple drugs and genes), clinical outcomes, healthcare utilization, and the genetic testing’s decreased cost.</li> <li><strong>Electronic Health Records (EHRs) Improvemen</strong>t: The Act seeks to enhance EHR systems with pharmacogenomic information to improve patient care and reduce adverse drug events. It includes assessing pharmacogenetics testing and PGx clinical decision support as an evidence-based prevention tool.</li> <li><strong>Education for Health Care Professionals</strong>: The Act also guides healthcare providers and healthcare leaders on adverse drug events and pharmacogenomic testing.</li> </ol> <p>Stakeholders can stay informed about the Right Drug Dose Now Act of 2024’s progress and updates in several ways:</p> <ol> <li><strong>Congressional Records</strong>: The official <a href="https://www.congress.gov/bill/118th-congress/house-bill/7848/text/ih">gov</a> website provides the bill’s full text, its current status, related bills, and all actions taken since Congress introduced it. It’s a reliable source for the most recent legislative information.</li> <li><strong>Official Communications from Representatives</strong>: U.S. Representatives <a href="https://swalwell.house.gov/media-center/press-releases/representatives-swalwell-and-crenshaw-introduce-bipartisan-legislation">Eric Swalwell</a> and Dan Crenshaw, who introduced the bill, provide updates on their official websites and social media platforms.</li> </ol> <p>In conclusion, while the PGx industry faces challenges due to new regulatory changes and continuing reimbursement issues, legislative advances offer hope for the future. PGx has by and far come a long way in clinical adoption terms in just the last ten years. By navigating the remaining challenges and capitalizing on new opportunities, the PGx industry can continue to evolve and play a crucial role in personalized medicine.</p> <p>References:</p> <p><a href="https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests">Laboratory Developed Tests | FDA</a> Accessed June 3. 2024.<br /> <a href="https://www.acla.com/acla-challenge-to-fdas-final-rule-regulating-laboratory-developed-testing-services-as-medical-devices/">ACLA Challenge to FDA’s Final Rule Regulating Laboratory Developed Testing Services as Medical Devices – American Clinical Laboratory Association</a> Accessed June 3, 2024.<br /> <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/LDT-and-CLIA_FAQs.pdf">LDT and CLIA_FAQs.pdf (cms.gov)</a> Accessed June 3, 2024.<br /> <a href="https://www.fightcancer.org/what-we-do/access-biomarker-testing">Access to Biomarker Testing | American Cancer Society Cancer Action Network (fightcancer.org)</a> Accessed June 3, 2024.<br /> <a href="https://a80.asmdc.org/sites/a80.asmdc.org/files/2023-06/AB%20425%20Fact%20Sheet.pdf">AB 425 Fact Sheet.pdf (asmdc.org)</a> Accessed June 3, 2024.<br /> Floor Report of the 2024-25 Budget. <a href="https://abgt.assembly.ca.gov/system/files/2024-06/floor-report-of-the-2024-25-budget-june-22-2024.pdf">floor-report-of-the-2024-25-budget-june-22-2024.pdf (ca.gov)</a> Accessed July 4, 2024.<br /> Who are the MACs: A/B MAC Jurisdiction M (J.M.). <a href="https://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/Who-are-the-MACs-A-B-MAC-Jurisdiction-M-JM">Who are the MACs: A/B MAC Jurisdiction M (J.M.) | CMS</a> Accessed July 4, 2024.<br /> U.S. Railroad Retirement Board. <a href="https://www.rrb.gov/node/2551">Palmetto GBA, RRB’s Medicare | RRB.Gov</a> Accessed July 4, 2024.<br /> Jonathan R. Nebeker, Paul Barach, Matthew H. Samore. <a href="https://www.acpjournals.org/doi/abs/10.7326/0003-4819-140-10-200405180-00009">Clarifying Adverse Drug Events: A Clinician’s Guide to Terminology, Documentation, and Reporting</a>. Ann Intern Med. 2004;140:795-801. [Epub May 18 2004]. <a href="https://www.acpjournals.org/doi/10.7326/0003-4819-140-10-200405180-00009">doi:10.7326/0003-4819-140-10-200405180-00009 </a><br /> <a href="https://www.fda.gov/drugs/drug-interactions-labeling/preventable-adverse-drug-reactions-focus-drug-interactions">Preventable Adverse Drug Reactions: A Focus on Drug Interactions | FDA</a> Accessed June 4, 2024.<br /> Meera Viswanathan, Carol E. Golin, Christine D. Jones, et al. <a href="https://www.acpjournals.org/doi/full/10.7326/0003-4819-157-11-201212040-00538">Interventions to Improve Adherence to Self-administered Medications for Chronic Diseases in the United States: A Systematic Review.</a> Ann Intern Med.2012;157:785-795. [Epub December 4 2012]. <a href="https://www.acpjournals.org/doi/10.7326/0003-4819-157-11-201212040-00538">doi:10.7326/0003-4819-157-11-201212040-00538</a><br /> U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. (2014). National Action Plan for Adverse Drug Event Prevention. Washington, DC: Author. <a href="https://health.gov/sites/default/files/2019-09/ADE-Action-Plan-508c.pdf">ADE-Action-Plan-508c.pdf (health.gov) </a><br /> <a href="https://academic.oup.com/painmedicine/article/17/12/2291/2741180">National Action Plan for Adverse Drug Event Prevention: Recommendations for Safer Outpatient Opioid Use | Pain Medicine | Oxford Academic (oup.com)</a> Accessed June 4, 2024.<br /> <a href="https://pharmacyhit.org/wp-content/uploads/WG4-ADE-v11.pdf">WG4-ADE-v11.pdf (pharmacyhit.org)</a> Accessed June 4, 2024.<br /> <a href="https://www.congress.gov/bill/118th-congress/house-bill/7848/text/ih">Text – H.R.7848 – 118th Congress (2023-2024): Right Drug Dose Now Act of 2024 | Congress.gov | Library of Congress</a> Accessed June 4, 2024.<br /> <a href="https://swalwell.house.gov/media-center/press-releases/representatives-swalwell-and-crenshaw-introduce-bipartisan-legislation">REPRESENTATIVES SWALWELL AND CRENSHAW INTRODUCE BIPARTISAN LEGISLATION TO PREVENT ADVERSE DRUG EFFECTS | Representative Swalwell (house.gov)</a> Accessed June 4, 2024.<br /> <a href="https://swalwell.house.gov/sites/evo-subsites/swalwell.house.gov/files/Right%20Drug%20Dose%20Now%20Act%20Final.pdf">Right Drug Dose Now Act Final.pdf (house.gov)</a> Accessed June 4, 2024.<br /> Ducoffe, A. R., Baehr, A., Peña, J. C., Rider, B. B., Yang, S., & Hu, D. J. (2016). Adverse Drug Event Prevention. American Journal of Medical Quality.<br /> United States: FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests. <a href="https://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests">FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests | FDA</a> Accessed July 4, 2024.</p>  </div></article></main></div></div><footer class="site-footer"><div class="wrap"><div class="creds"><p class="footer-links"><a href="https://corporate.thermofisher.com/en/footer/privacy-statement.html" target="_blank" rel="noopener noreferrer">Privacy Statement</a><a href="https://corporate.thermofisher.com/en/footer/terms-and-conditions.html" target="_blank" rel="noopener noreferrer">Terms & Conditions</a><a href="/blog/locations/">Locations</a><a href="/blog/sitemap/">Sitemap</a></p><p>© 2024 <a href="https://www.thermofisher.com">Thermo Fisher Scientific</a>. 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