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 July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...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 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
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
The Tennessee Department of Environment and Conservation (“TDEC”) and Henderson Hospital Corporation (“HHC”) entered into an August 23rd Settlement Agreement and Order (“Agreement”) addressing alleged violations of the...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
On July 8, 2024, OIG updated the Frequently Asked Questions on its website, adding four new questions and answers to its General Questions Regarding Certain Fraud and Abuse Authorities...more
The United States Environmental Protection Agency (“EPA”) and Los Robles Hospital Medical Center (“ Los Robles”) entered into a March 27th Expedited Settlement Agreement (“ESA”) addressing an alleged violation of the Federal...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 Emergency Medical Treatment and Active Labor Act ("EMTALA") provides that if a patient comes to a hospital or hospital-owned urgent care center, the hospital and relevant on-call physicians must provide an appropriate...more
The U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) have started a new effort to educate the public about the Emergency Medical Treatment and Labor Act (EMTALA)....more
The Office of Inspector General (OIG) recently issued two identical favorable OIG Advisory Opinions, concluding that, although the proposed arrangement (“Proposed Arrangement”) between a Medicare Supplement insurer (“MediGap...more
The Centers for Medicare and Medicaid Services (CMS) has increasingly focused its efforts on investigating hospital emergency departments for potential violations of the Emergency Medical Treatment and Labor Act (EMTALA),...more
Last month, CMS issued three civil monetary penalty (CMP) notices for violations of the hospital price transparency regulations (HPT Rule), which requires hospitals to make public the standard charges of the items and...more
On April 26, the Centers for Medicare and Medicaid Services (CMS) strengthened its enforcement of the hospital price transparency rule by implementing three new enforcement measures. These include...more
On December 19, 2022, OIG posted Advisory Opinion 22-20, responding to a request submitted by an acute care hospital (the Hospital) regarding the utilization of its employed nurse practitioners (NPs) to perform services that...more
Report on Medicare Compliance 31, no. 35 (September 26, 2022) - For the third time in about 2 1/2 years, hospitals or other providers that are part of Dartmouth-Hitchcock Health, a large health system in New Hampshire,...more
We previously discussed the requirements of the Hospital Price Transparency Rule (“Rule”) on health care providers and health plans, as well as CMS’s proposal to increase penalties for a hospital’s failure to comply with the...more
The Price Transparency Rule (the Rule) became effective on January 1, 2021. By October 2021, the Centers for Medicare & Medicaid Services (CMS) had issued warnings to over 300 hospitals deemed not in compliance with the...more
On August 4, 2021, the Centers for Medicare & Medicaid Services (CMS) published proposed changes to enforcement of the hospital price transparency rules that went into effect earlier this year. The proposed changes, part of...more
Report on Medicare Compliance 30, no. 28 (August 2, 2021) - CMS has not fined any hospitals yet for noncompliance with price transparency requirements, a spokesperson tells RMC. “In April 2021, CMS began issuing warning...more
The Centers for Medicare & Medicaid Services’ (“CMS”) message this year has been consistent – hospitals need to comply with CMS’ Hospital Transparency Rule. This rule requires hospitals and health systems to disclose a...more
The Centers for Medicare and Medicaid Services (CMS) has proposed increasing the penalty for violations of the hospital price transparency rule in the proposed outpatient pay rule announced on July 19, 2021. Hospitals...more
On July 19, 2021 the Centers for Medicare and Medicaid Services (CMS), as part of proposed rule covering a variety of subjects, including Medicare Hospital Outpatient and Ambulatory Surgery Center PPS modifications, issued a...more
Report on Medicare Compliance 30, no. 22 (June 14, 2021) - A Colorado radiation therapy provider has agreed to pay $3.569 million in a civil monetary penalty settlement with the HHS Office of Inspector General (OIG). ...more