Assistance with False Claims in Certified Health IT
We specialize in confidential regulatory matters, working on behalf of Health IT and EHR vendors, often through legal counsel. Contact our false claims experts today for a consultation.
Quandary Peak is among the nation’s leading expert consultant firms assisting both private industry and the federal government in complex matters related to compliance with ONC, CMS, and HHS regulations covering digital health.
We help private companies—including EHRs, digital health vendors, and all newly-defined “actors” under the Cures Act—communicate with regulators and government agencies, including assistance with responding to Civil Investigation Demands (CIDs) and false claims or fraud allegations related to ONC Certified Health IT testing, attestations and the Merit-based Incentive Payment System.
EHR Software Quality and Patient Safety Oversight
Experts at Quandary Peak are experienced in 3rd party quality and patient safety oversight for Health IT software vendors under Corporate Integrity Agreements (CIAs), serving the past 4 years as the designated Software Quality Oversight Organization (SQOO) for eClinicalWorks, LLC under their Corporate Integrity Agreement with HHS-OIG. We also work directly for health IT vendors under CIAs as expert software quality, compliance, and patient safety consultants.
In addition, Quandary Peak provides IV&V (Independent Verification and Validation) and ICE (Independent Consultative Expert) services related to Health IT software.
Quandary Peak serves all participants in the Health IT ecosystem, from software vendors, to the federal government, as well as providers, patients, insurers, non-profits, and research institutions.
What We Know
- ONC-ACB Testing, Surveillance and Attestation procedures, including new Conditions & Maintenance of Certification and Real World Testing Plans
- CEHRT program requirements, including RxNorm, SNOMED, NCPDP, CCDA and FHIR requirements
- Software safety and quality management standards, including medical device safety and SDLC standards, ISO 14971, ISO 62304 and ISO 13485
- Auditing standards, including standards for objectivity, independence and lack of bias in auditing
- Safety-Based Design and Health IT Safety and Compliance Program Mgmt
- RCA and CAPA processes for quality improvement
- HIPAA, cybersecurity and audit log requirements and best practices
What We Do
- Assist Health IT vendors in responding to legal or regulatory inquiries regarding Health IT regulations
- Assist Health IT companies, including compliance officers, patient safety officers, CMOs, CTOs, QA directors and others build out patient safety and compliance programs
- Review source code, databases, logs, and other artifacts to assess historic compliance with federal regulations for Certified Health IT
- Serve as monitors or quality oversight organization under CIAs or other probationary conditions.
- Perform IV&V services for government and Health IT contracts
- Help companies meet new Information Blocking and CMS Patient Access regulations
- Assist in qui tam proceedings
- Medical Coding and Billing
Medical Coding and Billing Oversight
The U.S. Healthcare Revenue Cycle Management ensures patients and health insurance organizations reimburse providers for services delivered. Quandary Peak’s Certified Medical Coding Experts serve as Medical Billing Expert Witnesses, detect billing errors, conduct line-by-line billing audits, and examine medical bills using analytics tools.
Meet Our Team of False Claims Experts
Dr. Ajit Dhavle is a healthcare technologist, clinician, entrepreneur, and a problem solver with 20 years of experience in digital health, quality, e-medications, Health IT standards, and patient safety. He oversees a team of health informatics experts to provide strategy, management, SDLC, compliance, and audit services to government and commercial entities.
Health ITFocus AreaHealth IT & Life Sciences
Alicia Morton Farlese is a retired Captain serving twenty-six years in the United States Navy Nurse Corps, and was a senior leader in national health IT policy at the US Dept. of Health and Human Services. Dr. Farlese assists clients in meeting Health IT regulations, including Information Blocking requirements of the Cures Act.
Health ITFocus AreaCompliance & Government Affairs
Shahzad Ahmad has a deep background in healthcare IT as a technical project manager and product owner. His 8+ years of experience includes implementation of EHR systems across the nation’s top healthcare institutions, owning the SDLC of medical devices, as well as bioengineering research of early detection technologies for debilitating diseases.
LitigationLitigationTestifying & Consulting Expert
Health ITFocus AreaEHR & Biomedical Product Design
Andrew Holm-Hansen has worked in Health IT for 15 years, and led several development teams during his career. As an Enterprise Architect, he distilled complex information that cut across legal, staffing, and technology boundaries, to provide decision-makers with actionable information.
LitigationLitigationConsulting Expert
Health ITFocus AreaSoftware Architecture & Engineering
Anna Mathias is a certified Project Manager with a focus in organizing, supporting, and contributing to work products related to Electronic Health Record (EHR) software quality, regulatory, and patient safety assessments. She is a strong leader and team player with excellent interpersonal and communication skills.
LitigationLitigationExpert Witness Support
Health ITFocus AreaSafety & Quality Assessments