Policy & Medicine

$25 Million Settlement Reached with Private Equity Firm for Alleged Involvement in…

Thomas Sullivan Nov 24, 2021 0

In mid-October 2021, the Massachusetts Attorney General’s Office announced the largest healthcare fraud settlement against a private equity firm based on the firm’s oversight of its healthcare portfolio company. The $25 million settlement stemmed from a qui tam suit filed under the Massachusetts False Claims Act by a former employee of South Bay…

November Issue of Policy and Medicine Compliance Update…

Thomas Sullivan Nov 13, 2021 0

Policy and Medicine Compliance Update — September 2021…

Thomas Sullivan Sep 11, 2021 0

$25 Million Settlement Reached with Private Equity Firm for…

In mid-October 2021, the Massachusetts Attorney General’s Office announced the largest healthcare fraud settlement against a private equity firm based on the firm’s oversight of its healthcare…

DOJ Alleges Kaiser Defrauded Medicare Out of $1 Billion

In October 2021, the United States Department of Justice (DOJ) intervened in a False Claims Act case against Kaiser Permanente, Kaiser Foundation Health Plan Inc., and certain other Permanente Medical…

California Electronic Prescribing Mandate to Take Effect January…

Starting January 1, 2022, nearly all prescriptions written in the state of California must be transmitted electronically, under a bill passed by the California State Legislature in 2018. Under the…

Texas Medical Association Files Lawsuit Against HHS Over Interim…

Recently, the Texas Medical Association (TMA) filed a lawsuit against the Department of Health and Human Services (HHS) over its interim final rule on surprise billing, alleging that it goes against…

DOJ Reaches $12.7 Million Settlement with kaléo Inc.

On November 9, 2021, the United States Department of Justice (DOJ) announced a $12.7 million settlement with kaléo Inc., resolving allegations that kaléo caused false claims to be submitted to…

Neurosurgeon and Two Medical Device Distributorships Settle…

Earlier this year, a neurosurgeon and two of his medical device distributorships reached a $4.4 million settlement to resolve False Claims Act allegations relating to illegal payments made to the…

CMS Issues CY 2022 Physician Fee Schedule, Including Open…

On November 2, 2021, the United States Centers for Medicare and Medicaid Services (CMS) issued the Calendar Year (CY) 2022 Medicare Physician Fee Schedule Final Rule. While many updates were made in…

Legislation Introduced to Create an Office of Rural Health

On November 3, 2021, Congressman A. Donald McEachin and Senator Jeff Merkley introduced the bicameral Rural Health Equity Act. If passed, the legislation would establish an Office of Rural Health…

November Issue of Policy and Medicine Compliance Update —…

Policy and Medicine Compliance Update is our monthly compliance publication designed to help compliance professionals go in depth in issues and stay up to date on the latest trends. We encourage you…

FDA Revises COVID-19 ANDA Guidance

In early September 2021, the United States Food and Drug Administration (FDA) revised its Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance…

AdvaMed Releases Code of Ethics on Interactions with Health Care…

On October 1, 2021, the Advanced Medical Technology Association (AdvaMed) Code of Ethics on Interactions with health care professionals in India (the Code) became effective. The Code provides medical…

Federal Judge Rules in Favor of Eli Lilly, Vacates HHS and HRSA…

On October 29, 2021, United States District Court Judge Sarah Evans Barker granted Eli Lilly’s request to vacate two administrative actions aimed at drugmakers and the 340B program discounts.…