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Clinical Documentation Integrity Specialist

• - Author and edit clinical documents, including Clinical Evaluation Reports (CERs), literature reviews, and regulatory submissions.
• - Plan and report clinical data collection for PMCF and clinical trials nationally and internationally.
• - Ensure clinical documentation compliance with EU MDR, FDA, and other international regulatory requirements.
• - Collaborate with Global Regulatory & Clinical Affairs teams to maintain clinical documentation within the Quality Management System.
• - Stay updated on scientific literature and regulatory changes within the company’s therapeutic area.
• - Participate in cross-functional projects and contribute to clinical strategy and documentation planning.
• - Support Medical Affairs for literature reviews and writing of documentation

Senior Medical Writer

• Completes initial patient medical record review within 24-48 hours of patient's admission; completes subsequent reviews of patient's medical record reviews every 24-48 hours and enters review findings in CDE software system
• Assigns Principal diagnosis, CC/MCC (complication and comorbidity/major complication and comorbidity), evaluate for Severity of Illness (SOI) and Risk of Mortality (ROM) on all patients while in-house.
• Assigns working ICD-10-CM and PCS codes and DRG (Diagnosis Related Group) using encoder in CDE software.
• Clarifies with physicians regarding missing, unclear, unsupported or conflicting health record documentation by requesting and obtaining additional documentation from physicians when needed.
• Educates key healthcare providers such as physicians, nurse practitioners, allied health professionals, nursing and care coordination regarding clinical documentation improvement, documentation guidelines and the need for accurate and complete documentation in the health record.
• Partners with coding professionals to ensure accuracy of diagnostic and procedural data and completeness of supporting documentation to determine the working and final DRG assignment.
• Reviews DRG denial letters and writes denial appeal letters.
• Collaborates with care coordination, nursing staff and other ancillary staff regarding interaction with physicians on documentation and to resolve physician clarifications prior to patient discharge.
• Maintains and upholds all clinical documentation regulatory guidelines.
• Formulates and submits timely, well prepared appeals for reconsideration by third party administrators (payors). Including supporting documented clinical evidence, Coding/CDE Guidelines and other regulatory standards/guidelines as appropriate.
• Works collaboratively with co-works and management to effectively resolve root cause issues that impact payor contracts, hospital operations, or departmental to maintain reimbursement and minimize appeal requests and/or denials.

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Clinical Documentation Integrity Specialist

Senior Medical Writer

RN Clinical Documentation Integrity