On February 7, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published a report entitled, “Technical Assistance Brief: Implementation of Inflation-Indexed Rebates for Part B Drugs.” ...more
On Friday, November 20, 2020, 60 calendar days prior to the inauguration of President-Elect Biden, the Trump administration released three rulemakings with significant implications for life sciences companies and healthcare...more
11/30/2020
/ Anti-Kickback Statute ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Life Sciences ,
OIG ,
Pharmaceutical Industry ,
Rulemaking Process ,
Stark Law ,
Trump Administration
On May 8, 2019, the Centers for Medicare & Medicaid Services (“CMS”) finalized the regulation (“Final Rule” or “DTC Rule”) requiring direct-to-consumer (“DTC”) prescription drug television advertisements to include the...more
5/14/2019
/ Acquisitions ,
Advertising ,
Centers for Medicare & Medicaid Services (CMS) ,
Direct to Consumer Sales ,
Drug Pricing ,
First Amendment ,
Lanham Act ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Wholesale
On October 15, 2018, the Centers for Medicare & Medicaid Services (CMS) published a Proposed Rule requiring disclosures by pharmaceutical manufacturers of the list price for certain drugs and biologicals directly or...more
While the Biologics Price Competition and Innovation Act (BPCI) was originally enacted under the Obama Administration as part of the Affordable Care Act, it appears that the Trump Administration will continue to take steps to...more
Centers for Medicare & Medicaid Services -
Overview -
On June 29, 2016, the Center for Medicare and Medicaid Innovation (CMMI or the Innovation Center) formally launched the Oncology Care Model (OCM) at the Cancer...more
Market Based Payment for Clinical Diagnostic Laboratory Tests -
Summary -
On June 17, 2016 the Centers of Medicare & Medicaid Services (CMS) issued the long awaited Medicare Clinical Diagnostic Laboratory Tests...more
7/5/2016
/ ADLT ,
Algorithms ,
Centers for Medicare & Medicaid Services (CMS) ,
CLFS ,
Clinical Laboratories ,
Clinical Laboratory Testing ,
Comment Period ,
Data Collection ,
Diagnostic Tests ,
MACs ,
Medicaid ,
Medicare ,
Medicare Advantage ,
PAMA ,
Payment Systems ,
Proposed Regulation ,
Provider Payments ,
Reporting Requirements
On December 5, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a final rule titled “Requirements for Medicare Incentive Reward Program and Provider Enrollment” (“the Rule”). The Rule implemented several...more