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) published the proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the Proposed Rule) on...more
1/27/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Fees ,
Medical Loss Ratio ,
Medicare ,
Medicare Advantage ,
Medicare Modernization Act ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmacy Benefit Manager (PBM) ,
Proposed Rules ,
Rebates ,
Social Security Act
Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers.
...more
3/3/2021
/ 21st Century Cures Act ,
Anti-Kickback Statute ,
Bonuses ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Commercially Reasonable Efforts ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Fair Market Value ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Medicare Part D ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Profit Sharing ,
Safe Harbors ,
Stark Law ,
Value-Based Care
With the change of administrations typically comes a flurry of activity across all government agencies, and the same can be expected with the official start of the Biden Administration now well underway. What should...more
2/1/2021
/ Biden Administration ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Final Rules ,
Government Agencies ,
Healthcare Fraud ,
Healthcare Reform ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Proposed Rules ,
Reimbursements
Final Rule largely tracks prior proposal to make significant changes to the Discount Safe Harbor and other regulatory safe harbors to the Federal Anti-Kickback Statute.
The Department of Health and Human Services Office of...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 March 11, 2020, the Centers for Medicare & Medicaid Services (CMS) announced a voluntary model within the Medicare Part D program that would allow certain Part D plans to cap Medicare beneficiaries’ out-of-pocket costs for...more
On March 10, 2020 the Centers for Medicare & Medicaid Services released a memo to Medicare Advantage Organizations and Part D Sponsors to inform them of their obligations and permissible flexibilities related to disasters and...more
The Centers for Medicare & Medicaid Services (CMS) published the Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program,...more
3/9/2020
/ Call Letter ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Cost-Sharing ,
Health Care Providers ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Pharmacies ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Reporting Requirements