KATHERINE PREGEL

Healthcare issues related to clinical laboratories; H.R. 2377/S. 1000, the Saving Access to Laboratory Services Act (SALSA), and a draft bill for inflation updates to the Medicare Clinical Laboratory Fee Schedule, provisions relating to reform of Medicare reimbursement for clinical laboratory services under Section 216 of the Protecting Access to Medicare Act, Pub. L. 113-93; H.R. 2369, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, provisions relating to FDA oversight of laboratory-developed tests, and other Federal policy relating to FDA oversight of laboratory-developed tests; H.R. 8702/S. 4518, the Improving Seniors Timely Access to Care Act, provisions relating to prior authorization of services to Medicare Advantage beneficiaries, and other Federal policy relating to prior authorization of services to Medicare Advantage beneficiaries; H.R. 3876/ S. 2323, the Access to Genetic Counselor Services Act, provisions relating to Medicare coverage of genetic counselor services; A draft of the Correct Coding Improvement Act, provisions related to laboratory procedure coding edits adopted by CMS under the National Correct Coding Initiative (NCCI), the adoption of Proprietary Laboratory Analysis (PLA) codes, and access to mandatory code sets for administrative transactions; Federal policy related to Medicare reimbursement for clinical laboratory tests for Alzheimers disease; Federal policy related to value-based care safe harbors under the federal anti-kickback statute; Federal policy related to supply chain issues affecting pre-clinical biomedical research for drug development; and Federal policy related to the frequency of U.S. Preventive Services Task Force updates to colorectal cancer screening guidelines.

Healthcare issues related to clinical laboratories; H.R. 2377/S. 1000, the Saving Access to Laboratory Services Act (SALSA), Section 301 of H.R. 8261, the Preserving Telehealth, Hospital and Ambulance Access Act, Section 401 of H.R. 7623, the Telehealth Modernization Act, Section 221 of Division B, Title II, Subtitle C of Pub. L. 118-83, 138 Stat. 1524, H.R. 9747, the Continuing Appropriations and Extension Act, 2025, and a draft bill for inflation updates to the Medicare Clinical Laboratory Fee Schedule, provisions relating to reform of Medicare reimbursement for clinical laboratory services under Section 216 of the Protecting Access to Medicare Act, Pub. L. 113-93; H.R. 2369, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, provisions relating to FDA oversight of laboratory-developed tests; H.R. 8818, the American Privacy Rights Act, provisions relating to privacy and security of data; H.R. 8702/S. 4518, the Improving Seniors Timely Access to Care Act, provisions relating to prior authorization of services to Medicare Advantage beneficiaries; Section 106(b) of H.R. 8261, the Preserving Telehealth, Hospital and Ambulance Access Act, and Section 103(b) of H.R. 7623, the Telehealth Modernization Act, provisions relating to Medicare program integrity for clinical diagnostic laboratory test claims; H.R. 1691, the Ensuring Patient Access to Critical Breakthrough Products Act, provisions related to Medicare coverage for breakthrough diagnostics; H.R. 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, provisions relating to reimbursement caps for covered tests; S. 2140, the Patent Eligibility Restoration Act, provisions relating to patent subject matter eligibility; A draft of the Cures 2.0 Act, provisions relating to personalized medicine; A draft of the Correct Coding Improvement Act, provisions related to laboratory procedure coding edits adopted by CMS under the National Correct Coding Initiative (NCCI), the adoption of Proprietary Laboratory Analysis (PLA) codes, and access to mandatory code sets for administrative transactions; Federal policy related to supply chain issues affecting pre-clinical biomedical research for drug development; and Federal policy related to the frequency of U.S. Preventive Services Task Force updates to colorectal cancer screening guidelines.

Section 201 of H.R. 7024, the Tax Relief for American Families and Workers Act, provisions relating to immediate deductibility of research and development expenses under Internal Revenue Code Section 174.

Healthcare issues related to clinical laboratories; H.R. 2377/S. 1000, the Saving Access to Laboratory Services Act (SALSA), Section 301 of H.R. 8261, the Preserving Telehealth, Hospital and Ambulance Access Act, and Section 201 of H.R. 7623, the Telehealth Modernization Act, provisions relating to reform of Medicare reimbursement for clinical laboratory services under Section 216 of the Protecting Access to Medicare Act, Pub. L. 113-93; H.R. 2369, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, provisions relating to FDA oversight of laboratory-developed tests; H.R. 8818, the American Privacy Rights Act, provisions relating to privacy and security of data; H.R. 8702/S. 4518, the Improving Seniors Timely Access to Care Act, provisions relating to prior authorization of services to Medicare Advantage beneficiaries; Section 106(b) of H.R. 8261, the Preserving Telehealth, Hospital and Ambulance Access Act, and Section 103(b) of H.R. 7623, the Telehealth Modernization Act, provisions relating to Medicare program integrity for clinical diagnostic laboratory test claims; A draft of the Correct Coding Improvement Act, provisions related to laboratory procedure coding edits adopted by CMS under the National Correct Coding Initiative (NCCI), the adoption of Proprietary Laboratory Analysis (PLA) codes, and access to mandatory code sets for administrative transactions; Federal policy related to supply chain issues affecting pre-clinical biomedical research for drug development; Federal policy related to the frequency of U.S. Preventive Services Task Force updates to colorectal cancer screening guidelines; and Federal policy related to womens health and digital health solutions.

Healthcare issues related to clinical laboratories; H.R. 2377/S. 1000, the Saving Access to Laboratory Services Act (SALSA), provisions relating to reform of Medicare reimbursement for clinical laboratory services under Section 216 of the Protecting Access to Medicare Act, Pub. L. 113-93; H.R. 2369, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, and the Fiscal Year 2025 Agriculture/FDA Appropriations bill, provisions relating to FDA oversight of laboratory-developed tests; Section 102 of H.R. 5378, the Lower Costs, More Transparency Act, and Section 3 of S. 3548, the Health Care Price Transparency Act 2.0, provisions relating to publication of rates for laboratory services; H.R. 7147/S. 3630, the Medicare Transaction Fraud Prevention Act, provisions relating to a Medicare pilot program using predictive risk algorithms to deny certain claims for clinical laboratory services; S. 3558, a bill to prohibit contracting with certain biotechnology providers; H.R. 7848, the Right Drug Dose Now Act, provisions relating to adoption of pharmacogenomic testing; A draft of the Correct Coding Improvement Act, provisions related to laboratory procedure coding edits adopted by CMS under the National Correct Coding Initiative (NCCI), the adoption of Proprietary Laboratory Analysis (PLA) codes, and access to mandatory code sets for administrative transactions; The Fiscal Year 2025 House and Senate Labor/HHS Appropriations bills, Federal policy related to funding for the CDC to establish lab test result harmonization and pediatric reference intervals; and Federal policy related to supply chain issues affecting pre-clinical biomedical research for drug development.

LABORATORY CORPORATION OF AMERICA HOLDINGS

LABORATORY CORPORATION OF AMERICA HOLDINGS

LABORATORY CORPORATION OF AMERICA HOLDINGS

LABORATORY CORPORATION OF AMERICA HOLDINGS