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 June 28, 2024, the U.S. Supreme Court issued a decision that overrules the “Chevron doctrine.” This means that federal agencies are limited in their ability to rely on their own interpretation of the laws they...more
Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....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
As the Sunshine Act reporting deadline of March 31, 2024 draws near, medical device and pharmaceutical companies are gearing up for their Sunshine Act reporting. Are you prepared for a Sunshine Act audit? Reporting...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
In coordination with the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) and Office of the National Coordinator for Health Information Technology (ONC) proposed a...more
As of September 1, 2023, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) can officially begin enforcement against Certified Health Information Technology (“HIT”) developers, health...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
The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims...more
On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule which, in part, seeks to amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for when an...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
A new California law (AB 1278) will require physicians and their employers to provide patients with several forms of notices about the Open Payments database, starting January 1, 2023. The law is intended to increase...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
The July 20, 2022 Special Fraud Alert describes findings from what OIG describes as “dozens of investigations of fraud schemes involving companies that purported to provide telehealth, telemedicine, or telemarketing services”...more
Federal enforcement of the 21st Century Cures Act’s (the Cures Act) prohibitions on improper blocking of electronic health information is ramping up. The Cures Act already targets technology developers and health information...more
The United States Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) leadership announced during last week’s HIMSS 2022 Conference that the agencies will be focusing on...more
On November 8, 2021, the United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) released an updated Self-Disclosure Protocol (SDP) (here). The revision of the SDP is an important...more
For the first time since 2013, on November 8, 2021, the Health and Human Services Office of Inspector General (“HHS-OIG” or “OIG”) made a number of significant updates to its Health Care Fraud Self-Disclosure Protocol...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
Report on Medicare Compliance 30, no. 11 (March 22, 2021) - University Medical Center of Southern Nevada has agreed to pay $128,820 in a civil monetary penalty settlement that stemmed from a self-disclosure. According to...more
The Department of Health and Human Services (“HHS”), in collaboration with the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the Inspector General (“OIG”), has issued two final rules clarifying certain...more
Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers. ...more
Report on Medicare Compliance 30, no. 7 (February 22, 2021) - A Michigan woman is the first in the nation to be charged criminally with misappropriating money from the Provider Relief Fund (PRF), the Department of Justice...more
As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules that significantly amend the regulations to the Physician Self-Referral Law (Stark Law), the federal...more
On January 18, 2021, a lawsuit was filed against the U.S. Department of Health and Human Services (“HHS”) and the Centers for Medicare and Medicaid Services (“CMS”) challenging a CMS policy change dating back to 2017. The...more