On Nov. 1, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that will increase payments to end-stage renal disease (ESRD) facilities in calendar year 2025. The ESRD prospective payment system (PPS)...more
On Jan. 17, 2024, McGuireWoods partners Kimberly Kannensohn and Sam Bernstein conducted a webinar regarding how the Health Insurance Portability and Accountability Act (HIPAA) applies to medical device companies and certain...more
The HHS Office of Inspector General issues a favorable advisory opinion regarding a sponsor’s payment of cost-sharing amounts in a Medicare Category B IDE Clinical Study; the FDA issues guidance regarding the use of Digital...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
On Oct. 23, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance in the form of questions and answers (Q&A) regarding manufacturers’ (Firms) dissemination of scientific and medical information on unapproved...more
This episode, Sam is joined by Sophie Mouros to discuss: a clinical trial fraud case involving allegedly fabricated data, the FDA’s withdrawal from the medical device Global Harmonization Working Party, the FDA’s recent...more
The HHS Office of Inspector General (OIG) issues an unfavorable advisory opinion regarding the provision of a value-added free hearing aid; the OIG issues comprehensive general compliance program guidance; the FDA issues an...more
On Oct. 27, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that will increase payments to end-stage renal disease (ESRD) facilities in calendar year (CY) 2024. The ESRD prospective payment system...more
On October 11, 2023, the U.S. Food and Drug Administration (FDA) announced that it will create and accept nominations for a new Digital Health Advisory Committee (DHA Committee) that will counsel the FDA on various issues...more
A DMEPOS supplier agrees to pay $29M to resolve False Claims Act allegations that it billed Medicare, MA Plans, and beneficiaries for oxygen equipment for which it had already received payment in full; the FDA releases...more
On June 23, 2023, the Department of Justice (DOJ) and Federal Trade Commission (FTC) announced a stipulated resolution with Easy Healthcare Corporation to address allegations that Easy Healthcare violated Section 5 of the FTC...more
A former DePuy Synthes sales representative is arrested for allegedly defrauding a hospital into submitting claims for products not actually used in surgery; A number of additional clinics enter into settlements to resolve...more
A mobile application developer of ovulation and period tracking software agrees to pay civil penalties and 20 years of independent monitoring for violating the Health Breach Notification Rule for sharing sensitive personal...more
The US Supreme Court rules that, under the Federal False Claims Act (FCA), the knowledge and subjective beliefs of a defendant at the time a false claim was submitted are determinative, and post hoc objectively reasonable...more
FDA releases updated guidance regarding the Q-Submission Program; C.R. Bard faces an unusual result in its patent dispute with AngioDynamics; A nurse practitioner pleads guilty to committing health care fraud by using...more
On May 2, 2023, the U.S. Department of Justice (DOJ) announced the indictment of two New York state pharmacy owners, Taesung Kim and Dacheng Lu, for their participation in an alleged $29 million healthcare fraud scheme. Kim...more
On Jan. 30, 2023, President Joe Biden announced that the COVID-19 public health emergency (PHE) will end May 11, 2023. Under the PHE, the federal government implemented a range of modifications and waivers impacting Medicare,...more
5/2/2023
/ CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance ,
Infectious Diseases ,
Medicaid ,
Medicare ,
Public Health Emergency ,
Telehealth ,
Telemedicine
On February 28, 2023, a federal jury in the District of Minnesota found the Cameron-Ehlen Group, d/b/a Precision Lens, and its founder and owner Paul Ehlen (the “Defendants”) guilty of paying kickbacks to ophthalmic surgeons...more
Rule Addresses Rate Increases, Outlier, Add-On and ETC Model Payments, Oral-Only Drugs and QIP Reporting -
On Oct. 31, 2022, the Centers for Medicare & Medicaid Services issued a final rule implementing an increase in...more
On July 20th, on the eve of trial, Biogen Inc. agreed to pay $900 million dollars to settle claims that the company violated the False Claims Act (FCA) by allegedly paying improper consulting and speaker fees and providing...more
On Feb. 28, 2022, the Center for Medicare and Medicaid Innovation (CMMI) published a Request for Applications for the second cohort of the Kidney Care Choices (KCC) Model, including the Centers for Medicare & Medicaid...more
On Nov. 16, 2020, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued a special fraud alert addressing fraud and abuse concerns with speakers programs conducted by pharmaceutical...more
On March 28, 2020, the Centers for Medicare & Medicaid Services (CMS) announced it was providing additional flexibility to end-stage renal disease (ESRD) facilities under the Medicare conditions for coverage at 42 CFR §§...more
On March 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an Open Payments Program COVID-19 announcement and released an updated comprehensive list of frequently asked questions about the Open Payments...more
On March 22, 2020, the U.S. Food and Drug Administration (FDA) published guidance that relieves manufacturers of FDA-cleared ventilator products of the requirement to submit a premarket notification (510(k)) prior to making...more