Clinical Rationale definition

Clinical Rationale means a statement or other documentation that taken together provides additional clarification of the clinical basis for a non-Certification determination. The Clinical Rationale should relate the non-Certification determination to the worker's condition or treatment plan, and must include a detailed basis for denial or non-Certification of the proposed treatment to give the provider or patient a sufficient basis for a decision to pursue an Appeal. Clinical Rationale must include specific reference to any applicable provisions of the Mississippi Workers' Compensation Medical Fee Schedule, which allegedly support the determination of the reviewer, or a statement attesting to the fact that no such provision(s) exists in the Fee Schedule.

Related to Clinical Rationale

  • Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Nationally recognized testing laboratory means any testing laboratory recognized by the accreditation program of the U.S. department of labor occupational safety and health administration.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.