Ken Callahan is currently a Principal at the Hargan Group where he does healthcare consulting, regulatory analysis and business development for healthcare providers, digital health, medical device and home health companies. Prior to that he was the Chief of Staff for the Deputy Secretary Eric Hargan (#2 official) in the Immediate Office of the Secretary (IOS) at the US Department of Health and Human Services (HHS). The Deputy Secretary's office plays the role of Chief Operating Officer for a department that has 27 agencies, 80,000 employees and an annual budget of $1.3 trillion. In this role, Callahan was responsible for executing the HHS/CMS payment rules and the allocation and distribution of $175 billion from the Provider Relief Fund. He also played major roles in department wide initiatives such as telehealth expansion during COVID-19, Stark and Anti-kickback reform, the Rural Health Action Plan, Interoperability rules and launching LymeX – the largest public-private partnership to combat Lyme disease in history. He began his career on Capitol Hill working for Congressman David Joyce (R-OH), then Congressman Mike Gallagher (R-WI) before joining HHS in January of 2018. Callahan received his BA from Ohio Wesleyan University and his Masters in Health Administration from Cornell University.
Wednesday November 15, 2023
Legislative and Regulatory Landscape Facing Telehealth, Artificial Intelligence, and Interoperability Adoption
- How CMS views consumerization as they make decisions on reimbursement for RPM and RTM technologies and understanding the regulatory process for SaMD at FDA and the next steps
- What to know about the recent Executive Order put out by the White House, and the recent HHS/ONC rule on interoperability.
- How Congress is wrestling with how to deal with PBM’s and digital health investment treants
Thursday August 25, 2022
Regulatory Landscape Facing Telehealth Innovation and Coverage
- An overview of Mayo Clinic investment and patient/provider experience in Acute Care at Home model and digital/remote health
- Leveraging remote monitoring and Software as medical device (SaMD) products
- Understanding the regulatory process for SaMD at FDA and next steps
- A look at the future of telehealth policy at HHS and CMS reimbursement on telehealth, focusing on how the PHE impacts telehealth coverage and reimbursement
- How CMS views consumerization as they make decisions on reimbursement for RPM and RTM technologies
- How leaders within HHS/CMS view the continual shift from FFS to VBC