On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the longstanding Chevron doctrine, under which courts generally granted deference to a federal agency’s reasonable interpretation of ambiguous...more
7/9/2024
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Centers for Medicare & Medicaid Services (CMS) ,
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Chevron v NRDC ,
Corner Post Inc v Board of Governors of the Federal Reserve System ,
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Food and Drug Administration (FDA) ,
Government Agencies ,
Healthcare ,
Judicial Authority ,
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Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
SCOTUS ,
Statutory Interpretation
On May 16th, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) to initiate the rescheduling of marijuana from a Schedule I to a Schedule III drug. The NPRM, which was published in...more
5/31/2024
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Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Farm Bill ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Internal Revenue Code (IRC) ,
Marijuana ,
Notice of Proposed Rulemaking (NOPR) ,
Regulatory Reform ,
Schedule I Drugs
The Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022, and includes key sections addressing climate and clean energy, corporate taxes and health care. The health care provisions...more
5/23/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Clean Energy ,
Climate Change ,
CMMI ,
Corporate Taxes ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Investment ,
Life Sciences ,
MedPAC ,
NIST
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
4/25/2024
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Centers for Medicare & Medicaid Services (CMS) ,
Congressional Review Act ,
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Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
GAO ,
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OMB ,
Payment Systems ,
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Prescription Drugs ,
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Proposed Guidance ,
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Regulatory Standards ,
Rulemaking Process
The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more
4/12/2024
/ Audits ,
Civil Monetary Penalty ,
Compliance ,
Corporate Culture ,
Corrective Actions ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Manufacturers ,
OCR ,
OIG ,
Pharmaceutical Industry ,
PHRMA ,
Policies and Procedures ,
Private Equity
Key Points - The scientific review supporting HHS’s recommendation to DEA that cannabis be reclassified from a Schedule I to a Schedule III drug was published on January 12, 2024. Classifying cannabis as a Schedule III...more
2/26/2024
/ Banking Acts ,
Biden Administration ,
Cannabis Products ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
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Popular ,
Public Comment ,
Schedule I Drugs
In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of...more
This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more
8/16/2023
/ Biden Administration ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Generic Drugs ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda
Congress is taking a closer look at business practices in the health care sector and considering bipartisan reforms in light of increasing consolidation and its perceived affects on patient access and affordability. Various...more
Are Accelerated Approval Drugs a New Target for Cost Reductions? As outlined in our prior analysis, the Inflation Reduction Act (IRA) included sweeping drug pricing reforms for the Medicare program and the Biden-Harris...more
The Biden-Harris administration and Congress appear poised to continue focusing on drug pricing issues this year, most notably with the Centers for Medicare & Medicaid Services moving forward with implementation of the drug...more
Key Points -
A new legal challenge to OIG on Medicare Beneficiaries’ ability to receive co-pay assistance has emerged. The Supreme Court has been asked to review HHS’s prohibition of co-pay assistance programs under the...more
Key Points -
Patient advocacy groups have filed suit challenging the legality of the 2020 HHS Final Rule permitting co-pay accumulator adjustment programs.
The Second Circuit has upheld HHS’ prohibition of co-pay...more
Key Points -
The new drug price negotiation process under the IRA takes into account a complex mix of price, competitive status, market exclusivity and scientific data.
New price setting provisions built into the IRA...more
The Inflation Reduction Act (IRA), P.L. 117-169, which became law on August 16th, included some of the most consequential prescription drug pricing reforms ever passed by Congress. This week marked a pivotal milestone in the...more
There continues to be no shortage of FDA-related issues in front of Congress this summer. In recent days, the pace of Congressional action on reauthorizing FDA’s user fee programs has significantly picked up with the Senate...more
Key Points -
Patient outcomes studies suggest a clinical benefit of co-pay programs, and a negative impact of co-pay accumulator programs.
Co-pay programs remain unavailable to participants in federal...more