The Centers for Medicare & Medicaid Services (CMS) and the US Department of Health and Human Services Office of Inspector General (OIG) continue to issue guidance regarding the implementation of the drug pricing provisions of...more
After many years of policy debate and attempts at proposed legislation, some of the most meaningful changes to the ways in which Medicare pays for prescription drugs – and the obligations of manufacturers selling drugs to...more
8/23/2022
/ Abbreviated New Drug Application (ANDA) ,
American Rescue Plan Act of 2021 ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Inflation Reduction Act (IRA) ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
New Legislation ,
Prescription Drugs ,
Section 340B
The Centers for Medicare & Medicaid Services (CMS) calendar year 2023 rule proposing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Proposed Rule) will officially be published in...more
7/20/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Federal Register ,
HCPCS ,
Infrastructure Investment and Jobs Act (IIJA) ,
Interim Final Rules (IFR) ,
Manufacturers ,
Medicare Part B ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Proposed Rules ,
Social Security Act
The Centers for Medicare & Medicaid Services (CMS) calendar year 2022 rule finalizing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Final Rule) was published on November 19, 2021....more
The Centers for Medicare & Medicaid Services (CMS) has released a proposed rule (the Proposed Rule) which, if finalized and adopted, would rescind the Trump Administration’s attempt to align reimbursement under Medicare Part...more
The Centers for Medicare & Medicaid Services (CMS) calendar year 2022 rule proposing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Proposed Rule) will officially be published in...more
Most Favored Nations Model will alter how certain Medicare Part B drugs are reimbursed.
The Centers for Medicare & Medicaid Services (CMS) released an advance copy of an interim final rule with a comment period announcing...more
The White House released a new Executive Order on September 13, 2020, related to drug prices titled “Lowering Drug Prices by Putting America First” the September Order), whose stated purpose is to address reimbursement for...more
9/17/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Medicare Part B ,
Medicare Part D ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
Mitigation ,
Prescription Drugs ,
Secretary of HHS ,
Trump Administration
CMS is soliciting comments on whether future payments for devices that may have been impacted by the COVID-19 PHE should be adjusted.
The Centers for Medicare & Medicaid Services (CMS) issued its annual proposed rule related...more
8/24/2020
/ 21st Century Cures Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
HCPCS ,
HOPPS ,
Interim Final Rules (IFR) ,
Manufacturers ,
Medical Devices ,
Medicare Part B ,
Medicare Part D ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Pharmacist ,
Physician Fee Schedule ,
Proposed Rules ,
Public Health Emergency ,
Social Security Act
The White House released three Executive Orders on July 24, 2020 setting forth policies that the Administration believes will “deliver lower prescription drug prices to American patients.” A fourth Executive Order tying...more
7/31/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
FQHC ,
Medicare Part B ,
Medicare Part D ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Public Safety ,
Safe Harbors
On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) released its annual proposed update to the hospital outpatient prospective payment system (Proposed Rule)....more