On August 10, 2021, the Centers for Medicare and Medicaid (“CMS”) published a proposed rule (“Proposed Rule”) to rescind the Most Favored Nation Model (“MFN Model”) interim final rule that was published on November 26, 2020...more
8/20/2021
/ Administrative Procedure Act ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Competition ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Interim Final Rules (IFR) ,
Medicare Part B ,
Prescription Drugs ,
Proposed Rules ,
Reimbursements
On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment...more
12/23/2020
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Final Rules ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Most-Favored Nations ,
Prescription Drugs ,
Reimbursements ,
Trump Administration
On Friday, March 27, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted. Organized below are concise summaries of select CARES Act sections that will impact various sectors of the health...more
3/31/2020
/ CARES Act ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
FQHC ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Long Term Care Facilities ,
Material Adverse Change Clauses (MACs) ,
Relief Measures ,
SBA ,
Telehealth ,
Waivers
On October 9, 2019, the Department of Health and Human Services (“HHS”) Centers for Medicare and Medicaid Services (“CMS”) and Office of Inspector General (“OIG”) released proposed rules in conjunction with HHS’ “Regulatory...more
10/11/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OIG ,
Physicians ,
Proposed Rules ,
Regulatory Requirements ,
Safe Harbors ,
Stark Law ,
Value-Based Care
When commercially available medications’ standard dosage forms or amounts don’t quite fit a patient’s particular needs, the patient may benefit from customized compounded drugs. Medicare Part D, the prescription drug program,...more