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
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$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
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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
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Medicare Part D ,
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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
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Prescription Drugs ,
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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
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Congressional Investigations & Hearings ,
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Drug Pricing ,
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Pharmacy Benefit Manager (PBM) ,
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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
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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
The Centers for Medicare & Medicaid Services (CMS) has initiated a new review process of existing national coverage determinations (NCDs). This new process is designed to retire old policies and may present increased risks to...more
CMS’s August 2013 notice establishes a new internal review process, signalling increased agency-initiated activity -
The Centers for Medicare & Medicaid Services (CMS or the Agency) has initiated an automatic,...more