Pharmaceutical Industry Sees a Win in 340B Fight
In a win for the pharmaceutical industry, the United States Court of Appeals for the Third Circuit recently ruled that the…
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DOJ and HHS OIG Commit to Working Together to Protect Health Care Markets
Recently, the Antitrust Division of the Department of Justice and the Department of Health and Human Services Office of the…
HHS Issues Proposed Rule to Modify ADR Process
Citing “policy and operational challenges” with the current 340B Administrative Dispute Resolution (ADR) Process, the US…
CMS Releases Proposal to Streamline Medicare Advantage and Part D
On December 14, 2022, the Biden administration released a proposal to streamline Medicare Advantage (MA) and Part D plan prior…
CMS Issues New Prior Authorization Rule
CMS has issued a new rule meant to streamline prior authorization by requiring certain payers to implement an electronic prior…
DOJ Announces Increased False Claims Act Penalties as a Result of Inflation
The Department of Justice has announced inflationary adjustments to the False Claims Act’s civil monetary penalties as a result of…
HHS OCR Issues a Bulletin About Online Tracking Technologies and HIPAA
The United States Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a bulletin to clarify…
Twentieth Annual Pharmaceutical Compliance Congress Coming April 2023
The 20th Pharmaceutical Compliance Congress (PCC) is scheduled to be delivered as a hybrid event from April 25, 2023, through…
Open Payments Data Updated
The Open Payments data is now updated to reflect changes to the data that took place since the June 2022 publication and is…
2022 FDA New Drug Approvals Lowest Since 2016
In 2022, the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) approved 37 new drugs…