Drug Pricing Initiatives: Congress is proceeding with the budget reconciliation process, which includes proposed measures related to drug pricing. House committees are beginning to mark up sections of the legislation related...more
9/14/2021
/ Budget Recollection Legislation ,
Budget Reconciliation ,
Congressional Budget Office ,
Drug Pricing ,
Medicaid ,
Medicare ,
Medicare Part B ,
Pharmacies ,
Prescription Drugs ,
Price Transparency ,
Section 340B
Drug Pricing Initiatives: On Aug. 24, 2021, the House of Representatives approved a $3.5 trillion budget framework, S. Cons. Res. 14, while also voting to advance the $1 trillion infrastructure bill. The deadline for the...more
8/31/2021
/ Biden Administration ,
Congressional Committees ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
HRSA ,
Life Sciences ,
Medicaid Drug Rebate Program ,
Medicaid Reimbursements ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Section 340B
$1 Trillion Infrastructure Bill Includes Two Drug Pricing Provisions: On Aug. 10, 2021, the Senate passed H.R. 3684, the Investing in a New Vision for the Environment and Surface Transportation in America Act, or the INVEST...more
8/17/2021
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health Care Providers ,
Life Sciences ,
Medicaid ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Section 340B
Drug Pricing Initiatives: US lawmakers continue to debate the drug pricing measure introduced by House Democrats, H.R. 3 (the Elijah E. Cummings Lower Drug Costs Now Act). Among other things, H.R. 3 would empower the...more
8/4/2021
/ Drug Pricing ,
Health Care Providers ,
Life Sciences ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation
PhRMA Suit Challenges Co-Pay/Accumulator Portion of December 2020 Medicaid Rule -
On May 21, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in the US District Court for the District of...more
5/24/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
HRSA ,
Medicaid ,
Medicare ,
Medicare Part B ,
OMB ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Legislation ,
Proposed Rules ,
Request For Information
Accelerated and advance payments, as well as higher reimbursement rates, aim to bridge the gap for US healthcare providers during COVID-19 crisis.
While US lawmakers and federal agencies have primarily focused on the...more
HHS proposes to remove rebates from the Anti-Kickback Statute’s “discount” safe harbor and add new safe harbor for point-of-sale discounts.
On January 31, 2019, the Department of Health and Human Services (HHS) announced a...more
2/6/2019
/ Anti-Kickback Statute ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Medicaid ,
Medicare ,
OIG ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Safe Harbors
Following a number of drug pricing reforms implemented or proposed in 2018, 2019 likely will bring more action from HHS and Congress to reduce drug prices.
Key Points:
..In 2018, the Administration implemented and...more
1/8/2019
/ Advertising ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Regulation ,
Regulatory Agenda ,
Reimbursements ,
Section 340B
Changes include increased transparency, delayed DMEPOS payment reductions, changed reimbursement for infusion drugs, changed hospital policies and more.
On December 13, 2016, President Obama signed into law the 21st...more
Proposed rule will create significant, retroactive reporting requirements for private payor payment rates to clinical laboratories.
Many clinical laboratories will need to expend significant resources to track, collect...more
In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices.
On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more