Medical Device Legal News with Sam Bernstein: Episode 10
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Investment Management Roundtable Discussion – Regulatory and Enforcement Update
FCPA Compliance and Ethics Report-Episode 131, The FCPA Professor Takes a Look Back at 2014
The United States Department of Health and Human Services, Office of Inspector General (“OIG”) recently released two unfavorable advisory opinions, OIG Advisory Opinion No. 25-04 and -08 (the “Opinions”) to medical device...more
On March 6, 2025, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced a civil money penalty (“CMP”) of $200,000 against Oregon Health & Science University (“OHSU”) for failing to...more
The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more
Every health care provider has “credit balances,” which occur when a provider receives more money than it is owed for services rendered. Credit balances can be caused by a number of factors, including incorrect coding,...more
As the shift toward value-based care continues to transform the healthcare industry, hospitals and health systems are increasingly utilizing incentive-based physician compensation structures. Incentive-based compensation...more
On December 11, 2024, OIG issued a Special Fraud Alert to warn the industry about the fraud and abuse risks associated with abusive Medicare Advantage (MA) organization (MAO) and agent and broker relationships with healthcare...more
A healthcare provider delivering pain management services in Florida and other states faces a $1.19 million civil monetary penalty from the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR)....more
The Centers for Medicare & Medicaid Services (CMS) recently made meaningful changes to its regulations interpreting the Affordable Care Act’s (ACA’s) so-called “60-day Rule,” which requires Medicare providers to affirmatively...more
On October 21, 2024, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced a civil monetary penalty (“CMP”) of $70,000 against a solo dental practice that provides family dental...more
On October 15, Maryland Attorney General Anthony G. Brown announced that his office reached a $27 million settlement with Precision Toxicology to resolve allegations that it submitted false claims to government health...more
In October 2024, the U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announced the imposition of a civil monetary payment against Providence Medical Institute (“PMI”), a large medical...more
Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we address a variety of topics including a recent SCOTUS ruling and the potential impact on CMS, issues of patient...more
The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently announced that it ordered American Medical Response (AMR) to pay a civil monetary penalty of $115,200 for failing to comply with the...more
On August 1, 2024, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced a civil monetary penalty of $115,200 against American Medical Response (“AMR”) based on a complaint that...more
On August 1, 2024, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) announced the imposition of a civil monetary penalty (“CMP”) of $115,200 collected against American Medical Response...more
On July 8, 2024, the Office of Inspector General (OIG) updated its General Questions on Fraud and Abuse Authorities (FAQs) related to the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Prohibition of Civil...more
Conducting due diligence for physician and provider compensation arrangements during a healthcare transaction is critical for the acquirer. Appropriate due diligence is necessary, regardless of whether the transaction is a...more
On June 10, 2024, the U.S. Justice Department announced that together with the Federal Trade Commission, it filed an amended complaint against telehealth company Cerebral Inc., Cerebral’s founder and former Chief Executive...more
The HIPAA Privacy, Security, and Breach Notification Rules apply to healthcare providers who engage in certain electronic transactions, healthcare clearinghouses, and health plans, including employee group health plans with...more
Kaiser Permanente is notifying 13.4 million current and former members that their personal information may have been compromised when it was transmitted to tech giants Google, Microsoft Bing and X (formerly Twitter) when...more
Telemedicine companies are supposed to facilitate medically necessary services to beneficiaries over the telephone via licensed medical professionals. In reality, however, many of these “telemedicine companies” are...more
Community Health Network (CHN) in Indiana has agreed to pay $345 million to settle false claims allegations that it paid over-the-top salaries to hundreds of physicians and rewarded them for their referrals in violation of...more
The government continued to dedicate enormous resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs in 2023. While we observed some civil False Claims Act settlements, criminal enforcement...more
On Oct. 20, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued unfavorable Advisory Opinion 23-08 (AO 23-08), continuing its long-held position that the provision of value-added...more
From 1998-2008, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published compliance program guidelines for various industries in the Federal Register....more