In a Memorandum Opinion, Judge Amit P. Mehta, of the U.S. District Court for the District of Columbia, vacated a U.S. Department of Health and Human Services (HHS) Final Rule, just days before its July 9 effective date. The...more
7/11/2019
/ Advertising ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Drug Pricing ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency ,
Social Security Act ,
Trump Administration ,
Vacated
The Centers for Medicare and Medicaid Services (CMS) announced a final rule, to be published on May 23, 2019, amending the Medicare Advantage program (Part C) and Prescription Drug Benefit program (Part D) regulations. ...more
5/20/2019
/ Amended Regulation ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Electronic Prescribing ,
Final Rules ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Rulemaking Process
On May 10, 2019, the Centers for Medicare and Medicaid published a Final Rule on drug pricing transparency in consumer advertisements. ...more
5/16/2019
/ Advertising ,
Biologics ,
Biopharmaceutical ,
Centers for Medicare & Medicaid Services (CMS) ,
Direct to Consumer Sales ,
Drug Pricing ,
False Advertising ,
Final Rules ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency ,
Rulemaking Process
The Centers for Medicare and Medicaid Services (CMS) announced a Proposed Rule to amend Medicare Advantage (MA) regulations and Prescription Drug Benefit program (Part D) regulations. The Proposed Rule will be published on...more
On June 1, 2018, the Health Resources and Services Administration (HRSA) announced it was once again delaying the final rule that had set forth the calculation for the 340B Program ceiling price and drug manufacturer civil...more
The Office of Inspector General (OIG), Health and Human Services issued an Advisory Opinion allowing an arrangement proposed by a federally qualified health center look-alike (FQHC look-alike) to provide free technology items...more
6/5/2018
/ Advisory Opinions ,
Anti-Kickback Statute ,
Drug Pricing ,
FQHC ,
Health Care Providers ,
Medicaid ,
Medical Reimbursement ,
Medicare ,
OIG ,
Section 340B ,
State Funding ,
Telemedicine
The Centers for Medicare and Medicaid Services (CMS) issued the 2018 Medicare: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Final Rule with comment...more
11/8/2017
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Critical Access Hospitals ,
Drug Pricing ,
Final Rules ,
Hospitals ,
Inpatient Billing ,
Inpatient Quality Reporting ,
Outpatient Prospective Payment System (OPPS) ,
Outpatient Quality Reporting ,
Section 340B