This week, the U.S. Department for Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) released a proposed rule (the Medicare and Medicaid Programs: Contract Year 2021 and 2022 Policy and...more
At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part...more
12/30/2019
/ Code of Federal Regulations (CFR) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
FDA Commissioner ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Imports ,
NPRM ,
Popular ,
Prescription Drugs ,
Public Comment ,
Regulatory Requirements ,
Rulemaking Process ,
Secretary of HHS ,
Supply Chain ,
Trump Administration
On January 31, 2019, the U.S. Department of Health & Human Services (HHS) issued a proposed rule that would amend the discount safe harbor under the Anti-Kickback Statute (AKS) to eliminate protection for certain drug...more
2/5/2019
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Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Safe Harbors
On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration’s plan to lower drug prices and reduce out-of-pocket costs....more
5/14/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Manufacturers ,
Medicaid ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Comment ,
REMS ,
Section 340B ,
Trump Administration
Last week, Senate Finance Committee Ranking Member Ron Wyden (D- Ore.) introduced the “Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017.” As its name suggests, it seeks to require parties (e.g., PBMs)...more
3/22/2017
/ Department of Health and Human Services (HHS) ,
Disclosure ,
Drug Pricing ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Rebates ,
Sensitive Business Information ,
State Health Insurance Exchanges ,
Transparency
Last week, the Centers for Medicare & Medicaid Services (“CMS”) released its 2018 Notice of Benefit and Payment setting out payment parameters for the Health Insurance Marketplace for upcoming years. With several insurers...more
Last week, HHS, along with the Department of Labor and the Treasury, provided long overdue guidance regarding the third category of supplemental “excepted benefits” as defined by Section 2791 of the Public Health Services...more
As we have been discussing, the Affordable Care Act (“ACA”) requires all health plans to cover preventive health services for women, including all Food and Drug Administration (“FDA”)-approved contraceptives, at no cost (i.e....more
10/31/2014
/ Affordable Care Act ,
Burwell v Hobby Lobby ,
Contraceptive Coverage Mandate ,
Contraceptives ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Employer Mandates ,
First Amendment ,
Food and Drug Administration (FDA) ,
Religious Exemption ,
Religious Freedom Restoration Act (RFRA) ,
SCOTUS
As has been widely covered in the news, regulations and guidance developed under the Affordable Care Act (“ACA”) require that non-grandfathered health plans make preventive care and screenings available to their members at no...more