Superior Quality, Complete Control
DrLabs365 empowers physicians to own high-quality laboratory services with 24-hour turnarounds, enhancing patient care through direct control of testing protocols
Please reach us at sharpmarketingtx@gmail.com if you cannot find an answer to your question.
Our physician-owned laboratory model is structured to ensure full compliance with federal Anti-Kickback Statute requirements. Physicians maintain appropriate "skin in the game" by directly purchasing inventory and employing clinical staff involved in specimen collection. All management fees and equipment leasing rates are established at fair market value through arm's-length negotiations and never vary based on test volume. Laboratory space arrangements include clear documentation of exclusive physician control during specified times, with electronic access controls providing security and proper regulatory separation.
Our model satisfies the In-Office Ancillary Services Exception through careful structuring of laboratory operations. The laboratory qualifies as a "centralized building" used by the practice for clinical services, with documented exclusive control during specified periods. All agreements are structured for minimum one-year terms with advance-set compensation at fair market value, independent of referral volume. We maintain complete separation between technical operations and clinical decision-making to ensure physicians retain independent medical judgment.
We provide comprehensive guidance through the entire CLIA application process while ensuring the practice maintains proper regulatory relationships by paying licensing fees directly. Our systems establish separate recordkeeping for each laboratory, including quality control documentation and procedure manuals. We ensure compliance with CMS shared laboratory location guidance through non-overlapping operational hours and provide qualified Laboratory Directors who review and approve all testing methods.
Our model addresses pass-through billing concerns by establishing the physician practice as the actual provider of laboratory services with genuine financial investment. Documentation systems clearly identify the physician practice as the laboratory provider with appropriate identification of testing location. All testing performed complies with medical necessity requirements and is appropriately ordered by authorized providers with proper clinical documentation. Our controls ensure accurate coding practices that meet all documentation requirements of Medicare, Medicaid, and commercial insurers.
All agreements clearly delineate responsibilities, with physicians maintaining appropriate business risk through direct investment in laboratory operations. We implement proper controls to ensure no laboratory refers more than 30% of tests to outside reference laboratories, maintaining proper testing relationship boundaries. Our comprehensive documentation systems and training ensure ongoing compliance with all applicable regulations while delivering high-quality testing services to patients.
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If you have questions about the testing programs available to you, feel free to send us a message. We will get back to you as soon as possible.
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