Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more
3/26/2024
/ Children's Health Insurance Program (CHIP) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Health Insurance ,
Healthcare Reform ,
HRSA ,
Legislative Agendas ,
Life Sciences ,
MACPAC ,
Manufacturers ,
Medicaid ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Agenda ,
Section 340B
On August 15, 2023, the U.S. Court of Appeals for the Tenth Circuit (the “Tenth Circuit”) issued its decision in Pharmaceutical Care Management Association (PCMA) v. Mulready, one of the first major opinions to further define...more
8/31/2023
/ Drug Pricing ,
Employee Retirement Income Security Act (ERISA) ,
Health Insurance ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Preemption ,
Prescription Drug Coverage ,
Prescription Drugs ,
Rutledge v Pharmaceutical Care Management Association ,
SCOTUS
On June 9, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its next list of Part B drugs subject to the Medicare Prescription Drug Inflation Rebate Program’s adjusted coinsurance rates (“Rebatable Drugs”) from...more
The Centers for Medicare & Medicaid Services (CMS) recently issued initial guidance on how the agency expects the Medicare Drug Price Negotiation Program (the “Negotiation Program”) to operate. The Negotiation Program was...more
On June 7, 2022, the Federal Trade Commission (FTC) unanimously voted to initiate a study into how business practices employed by some pharmacy benefit managers (PBMs) may impact prescription drug pricing and patient access...more
On November 30, 2020, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a final rule (“Final Rule”) that removes safe harbor protection under the discount safe harbor to...more
On January 31, 2019, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a proposed rule (“Proposed Rule”) that would restrict safe harbor protection under the federal Anti-Kickback...more
2/6/2019
/ Anti-Kickback Statute ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Health Insurance ,
Health Plan Sponsors ,
Manufacturers ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Rebates ,
Request For Information ,
Safe Harbors
On November 28, 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan,...more
1/5/2018
/ Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Generic Drugs ,
Hospitals ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Proposed Rules
On September 19, 2014, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released a study showing that pharmaceutical manufacturer safeguards to prevent Medicare Part D (“Part D”)...more