The Center for Medicare and Medicaid Innovation ("CMMI") announced sweeping changes to the Kidney Care Choices Model ("KCC Model"), a key set of value-based programs....more
7/14/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Medicare ,
Patent Quality Metrics ,
Patient Access ,
Physicians ,
Regulatory Reform ,
Trump Administration ,
Value-Based Care
The Center for Medicare and Medicaid Services ("CMS") has announced significant changes to its value-based payment model portfolio projected to save $750 million as part of a shift in the agency's refocused strategy toward...more
4/16/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Government Agencies ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medicaid ,
Medicare ,
Physicians ,
Regulatory Reform ,
Value-Based Care
Following a jury's verdict, a federal court slashed civil penalties under the False Claims Act ("FCA") as violative of the Constitution's 8th Amendment....more
3/28/2025
/ Constitutional Challenges ,
Damages ,
Eighth Amendment ,
Excessive Fines Clause ,
False Billing ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Healthcare Fraud ,
Medicare ,
Penalties ,
Treble Damages
The Increasing Organ Transplant Access Model ("IOTA Model") introduces mandatory financial incentives and penalties for selected kidney transplant hospitals....more
1/29/2025
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Healthcare ,
Hospitals ,
Incentives ,
Medicare ,
Organ Transplant Centers ,
Penalties ,
Regulatory Requirements ,
Value-Based Care
The Federal Trade Commission ("FTC") intends to "strengthen and modernize" the Health Breach Notification Rule with revamped and increased scrutiny on entities holding health information, including health apps, websites, and...more
In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more
In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more
4/8/2024
/ Anti-Kickback Statute ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
Medicare Advantage ,
OIG ,
Stark Law
New, first-of-their-kind consumer health data privacy laws in Washington and Nevada are designed to provide state-level protections for personal health data not covered by the Health Insurance Portability and Accountability...more
In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, the government obtained more than $2.6 billion in overall recoveries,...more
4/1/2024
/ Anti-Kickback Statute ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
Medicare Advantage ,
OIG ,
Stark Law
Qui tam relators and the U.S. Department of Justice continue to expand usage of the False Claims Act....more
3/4/2024
/ Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
Qui Tam ,
Settlement ,
Whistleblowers ,
White Collar Crimes
The Department of Health and Human Services ("HHS") has released voluntary cybersecurity performance goals for the health care and public health sectors, which outline an increasingly standardized regulatory approach and...more
2/19/2024
/ Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Popular ,
Proposed Regulation ,
Public Health
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
1/12/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
OCR ,
Popular ,
Proposed Rules ,
Public Health ,
Regulatory Requirements ,
Risk Mitigation
In Short -
The Situation: On November 6, 2023, the Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") released its "General Compliance Program Guidance" ("GCPG"). The GCPG...more
12/1/2023
/ Anti-Kickback Statute ,
Compliance Management Systems ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Federal Register ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
OIG ,
Physicians ,
Stark Law
This new legislation supports the Health Resources and Services Administration ("HRSA") modernization initiative announced in March, including several actions to strengthen accountability and transparency in the Organ...more
The U.S. Department of Health and Human Services, Office of Inspector General ("OIG") has provided insight into the applicability of the discount and group purchasing organization safe harbors to payments retained by pharmacy...more
DOJ recovers a record $5.6 billion from FCA cases in 2021, the largest annual total since 2014. -
The United States Department of Justice Civil Division ("DOJ") recently announced a recovery of more than $5.6 billion in...more
2/23/2022
/ Anti-Kickback Statute ,
Cyber Crimes ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
Medicare Advantage ,
Paycheck Protection Program (PPP) ,
Qui Tam
Health care industry participants frequently operate under nuanced legal frameworks that apply to the receipt of government funds. A breach of these regulations can open the door to draconian liability under the FCA even when...more
2/14/2022
/ False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Liability ,
Qui Tam ,
Regulatory Standards ,
Regulatory Violations ,
Relators ,
Scienter ,
Statutory Interpretation