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DEA Releases Rules on Telemedicine Prescribing of Controlled Substances, Proposes Special Registrations

The Drug Enforcement Administration ("DEA") announced three new regulations related to the prescription of controlled substances resulting from a telemedicine encounter, including the long-anticipated Proposed Rule on Special...more

CMS Finalizes The Increasing Organ Transplant Access Model

The Increasing Organ Transplant Access Model ("IOTA Model") introduces mandatory financial incentives and penalties for selected kidney transplant hospitals....more

HHS Announces Upcoming Federal Strategies to Enhance Cybersecurity for Health Care and Public Health Sectors

The Department of Health and Human Services ("HHS") has released a concept paper outlining its new cybersecurity strategies for the health care sector, identifying cybersecurity priorities, potential future regulations and...more

Food, Drugs, Cosmetics, and Devices: Federal Regulatory Focus Areas in 2023

In Short - The Situation: With the calendar officially turned to a new year several significant changes and regulatory initiatives are on the horizon at the Food and Drug Administration ("FDA")....more

California Attorney General Issues Bulletin on Health Data Breach Reporting Requirements

The California Attorney General ("AG") has issued guidance reminding health care providers of their duty to report health care data breaches and to comply with other state and federal data privacy laws....more

Newly Proposed AKS and Stark Law Protections For Value-Based Care Models

The Situation: The Department of Health and Human Services has introduced the Regulatory Sprint to Coordinated Care Initiative in order to revise regulations associated with the anti-kickback statute, Stark Law, HIPAA, and 42...more

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