CMS Releases Second Interim Final Rule on Surprise Billing
On September 30, 2021, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule (IFR) to address large…
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2021
Sutter Health Reaches Largest FCA Settlement Against Hospital System for…
Major California hospital system Sutter Health is settling whistleblower allegations of risk adjustment fraud for $90 million, the…
Illinois Health Care Professionals Must Learn About Alzheimer’s
Recently, Illinois Governor JB Pritzker signed legislation that mandates licensed health care professionals who treat patients 26…
FDA Issues Draft Guidance on RWD Sourced from EHRs and Medical Claims Data
In late September 2021, the United States Food and Drug Administration (FDA) issued draft guidance, Real-World Data: Assessing…
FDA REMS Pain Management and Opioid Therapy: Persistent Knowledge Gaps…
The opioid epidemic that has gripped the US for over 20 years has worsened during the ongoing COVID-19 pandemic with the highest…
Oregon Publishes Proposed Rules on Pharmaceutical Representative Licensure…
On October 5, Oregon’s Department of Consumer and Business Services (“DCBS”) held a public meeting to discuss the proposed rules…
FDA Requests Input on How to Handle Post-Approval Regulation of PANDAs
The US Food and Drug Administration (FDA) recently asked for input from stakeholders on how it should handle certain drugs…
CMS Issues IPPS Final Rule for FY 2022
On August 2, 2021, the Centers for Medicare and Medicaid Services (CMS) issued its hospital inpatient prospective payment system…
California Law Makes Changes to CME
Recently, the State of California enacted Assembly Bill 359, which would expand the definition of continuing medical education…
Biopharmaceutical Companies Send Open Letter to Congress
On September 15, 2021, member companies of the Pharmaceutical Research and Manufacturers of America (PhRMA) made public an open…