PRECISION MEDICINE AND HEALTHCARE ADMINISTRATION: Implementing Genomic Data Systems, Regulatory Compliance, and Revenue Cycle Management in Precision Care Facilities - Softcover

Oles, Dr. John M.

Softcover

ISBN 13: 9798196493348

Publisher: Independently published, 2026

Synopsis

Precision medicine has arrived in the clinic. Genomic testing panels are embedded in oncology protocols, pharmacogenomic alerts fire in EHR workflows, hereditary risk programs counsel thousands of patients annually, and health systems are making nine-figure investments in the informatics infrastructure that makes molecularly guided care possible.
What has not kept pace is the administrative infrastructure required to sustain it.
Genomic testing reimbursement is contested, payer-specific, and perpetually evolving. HIPAA's application to genomic data involves re-identification risks and regulatory gray zones that standard privacy training does not address. ICD and CPT coding for molecular diagnostics requires specialized expertise that most revenue cycle departments do not yet possess. And the organizational change management required to integrate precision medicine workflows into existing clinical operations — across departments, facilities, and care settings that were not designed with molecular data in mind — demands administrative leadership of exceptional sophistication.
The regulatory compliance section provides the most operationally complete treatment of HIPAA's application to genomic data environments available for administrative audiences. It covers the business associate agreement landscape for genomic vendors and cloud providers, the de-identification limitations unique to genomic sequences, the Common Rule's consent requirements for biobanking and secondary research use, the 21st Century Cures Act's information-blocking provisions as they apply to genomic test results in designated record sets, and the FDA regulatory framework governing AI-based clinical decision support tools increasingly embedded in precision medicine workflows. International compliance considerations — GDPR's classification of genetic data as a special category of sensitive personal information, PIPEDA requirements for Canadian operations — are addressed for health systems with international patient populations or research collaborations.
Revenue cycle management for precision medicine receives the sustained, expert treatment it has never before received in textbook form. The book addresses the complete billing and reimbursement lifecycle for molecular diagnostic services: CPT coding for genomic panels, single-gene tests, pharmacogenomic assays, and liquid biopsy procedures; ICD-10-CM coding for genomic indications and hereditary risk conditions; Medicare coverage policies including MolDx program requirements and local coverage determinations that govern reimbursement for next-generation sequencing panels; Medicaid and commercial payer prior authorization strategies for high-cost genomic tests; appeals and denial management specific to molecular diagnostic claims; and the financial modeling frameworks health system administrators need to evaluate the return on precision medicine program investment across clinical, research, and operational dimensions.
The book closes with a forward-looking treatment of the administrative landscape precision medicine is creating: value-based care contracting for genomic medicine, the administrative implications of polygenic risk score integration into preventive care programs, the facility planning requirements of spatial transcriptomics and next-generation diagnostic platforms, and the equity dimensions of precision medicine access that health system administrators have both an ethical obligation and a strategic interest in addressing.

Edition details

• Publisher: Independently published
• Publication date: 2026
• Language: English
• ISBN 13: 9798196493348
• Binding: Paperback
• Number of pages: 419