When Congress adopted the Inflation Reduction Act (IRA) in 2022, creating the Medicare Drug Price Negotiation Program (MDPNP), the bill did not receive support from any Republican senators....more
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
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Department of Health and Human Services (HHS) ,
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Healthcare Reform ,
HRSA ,
Legislative Agendas ,
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MACPAC ,
Manufacturers ,
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Pharmaceutical Industry ,
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Regulatory Agenda ,
Section 340B
On January 23, 2023, CMS published in the Federal Register its first proposed rulemaking to implement the Medicare Drug Price Negotiation Program (the “Negotiation Program”), which is included in the Inflation Reduction Act...more
On August 16, 2022, President Biden signed into federal law the Inflation Reduction Act (IRA), which, among other priorities for the Biden administration, addresses prescription drug costs and drug prices in the Medicare...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
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Department of Health and Human Services (HHS) ,
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Health Care Providers ,
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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