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
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 saga that led Children’s Hospital Colorado to accept a fine of more than $500,000 imposed by the HHS Office for Civil Rights (OCR) began on July 11, 2017, when a physician’s email account containing details on 3,300...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-12 (the “Opinion”) to a pharmaceutical manufacturer (the...more
December 2024 was an active month for the U.S. Department of Health and Human Services ("HHS"), Office for Civil Rights ("OCR"). OCR announced (i) a $1.19 million civil monetary penalty ("CMP") against Gulf Coast Pain...more
The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more
The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...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
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
In connection with the November 2023 Health Care Compliance Association’s (HCCA) Healthcare Enforcement Compliance Conference, and with acknowledgment by the Chief Counsel to the Inspector General, Rob DeConti, of the long...more
On February 17, 2023, the US Department of Health and Human Services Office for Civil Rights (OCR) released two companion reports to Congress detailing its actions in 2021 to enforce the privacy, security, and breach...more
The Office of Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) recently submitted two annual reports to Congress setting forth a summary of complaints and breaches reported to the OCR during...more
The Biden Administration has embraced an aggressive and multi-part agenda designed to improve the safety and quality of care nationally in skilled nursing facilities (SNFs). The Biden Administration’s nursing home agenda...more
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) continues its enforcement activities to emphasize compliance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule’s...more
By letter dated April 13, 2021 (Letter), the Democrat and Republican leadership of the House Committee on Energy and Commerce and its Subcommittee on Health, wrote United States Health and Human Services Secretary, Xavier...more
Report on Medicare Compliance 29, no. 45 (December 21, 2020) - CMS said Dec. 18 it will audit a sample of hospitals for compliance with price transparency requirements, which take effect Jan. 1, according to MLN Connects....more
The U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released an interim final rule on October 29, 2020, delaying the implementation of the...more
Time Is Ripe To Update SOPs And To Ensure Compliance with Results Submission Requirements - In recent days, the federal Department of Health and Human Services (“HHS”) clarified the requirements for submission of certain...more
Report on Medicare Compliance 29, no. 20 (June 1, 2020) - The HHS Office of Inspector General (OIG) has unveiled its “OIG Strategic Plan: Oversight of COVID-19 Response and Recovery.” Its goals are protecting people, funds...more
Report on Medicare Compliance 29, no. 16 (April 27, 2020) - The HHS Office of Inspector General (OIG) has proposed a rule on civil monetary penalties (CMPs) for information blocking and fraud related to HHS grants, contracts...more
On April 21, 2020, the U.S. Department of Health and Human Services released a series of announcements signaling its intention to finalize and enforce certain aspects of the Office of the National Coordinator (ONC) Cures Act...more
Report on Medicare Compliance 29, no. 15 (April 20, 2020) - Maury Regional Medical Center in Tennessee has agreed to pay $1.7 million to settle false claims allegations over MS-DRG coding, the U.S. Attorney’s Office for...more
Report on Medicare Compliance 29, no. 2 (January 20, 2020) - - The HHS Office of Inspector General has updated its Work Plan, which includes an item on early discharges from inpatient rehabilitation facilities to home...more
Report on Patient Privacy 19, no. 12 (December 2019) - Sentara Hospitals, a nonprofit group of 12 medical centers in Virginia and North Carolina, will implement a fairly minimal two-year corrective action plan (CAP) and...more
Compliance Today (November 2019) - On September 9, 2019, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services announced its first enforcement action and settlement in its Right of Access...more
2017 was slightly above average for new corporate integrity agreements (CIAs), with 46 entered into by the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and companies and individuals...more