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Keeping you afloat admidst the rising sea of regulations

New VA Policy: All Covered Drugs, Regardless if Compliant with the Trade Agreements Act, Must Be Offered

The Department of Veterans Affairs (VA) recently announced a significant policy change that will now require drug manufacturers to make drugs that are “covered drugs” under the Veterans Health Care Act (VHCA) available to the VA under the manufacturer’s Federal Supply Schedule (FSS) contract, even if those drugs are not compliant with the requirements of Trade Agreements Act (TAA). The announcement from the VA establishes aggressive deadlines for compliance, which manufacturers should note.  

HHS Re-Opens Comment Period on 340B Program Pricing and Penalty Rule

Today, the Department of Health and Human Services (HHS) announced that they are re-opening the comment period on its June 17, 2015 proposed rule (the Proposed Rule) concerning establishment of the “Ceiling Price” for covered outpatient drugs (340B drugs) and assessment of penalties against manufacturers for violation of 340B pricing rules. Arent Fox LLP previously provided an analysis of the Proposed Rule on our blog, Health Care Counsel, which you can access

DEA Considers Rescheduling Marijuana

The US Drug Enforcement Administration recently announced that it is evaluating whether to downgrade the classification of marijuana under the Controlled Substances Act, which could allow more research into its potential medicinal benefits. A decision is expected this summer.  

Pharmaceutical, Chemical & Biotech Litigation: Year In Review

As in previous years, 2015 brought a combination of expected and unexpected holdings by the Supreme Court and the Federal Circuit.  On the expected side of the ledger, the Supreme Court continued its pattern of reversing the Federal Circuit, this year regarding claim construction and induced infringement.

CMS Delays Implementation of Revised 5i Average Manufacturer Price (AMP) Methodology and 70/30 Test until July 1, 2016

On March 31, 2016, CMS published a Manufacturer Release delaying implementation of the revised 70/30 test which manufacturers are to utilize to assess whether a 5i drug is generally dispensed at retail, as well as the 5i AMP methodology prescribed in the final AMP rule and codified at 42 CFR 447.504, until July 1, 2016.

Alternative, Value Based Payment Models Reach Part B Drugs

The Centers for Medicare & Medicaid Services (CMS) released a proposed rule on March 8, 2016 (published in the Federal Register on March 11, 2016) which could fundamentally change the way in which drugs administered in the physician office or hospital outpatient department settings (generally referred to here as Part B Drugs) are reimbursed by the Medicare program.

CVS Settles Controlled Substances Act Claim for $8 Million

As part of the federal government’s multi-front attack on opioid abuse, the Department of Justice announced on Friday, February 12 that CVS Pharmacy, Inc. has agreed to pay $8 million to settle allegations that it violated the Controlled Substances Act (CSA).

New Law Allows Texas State Board of Pharmacy to Scrutinize Compounding Pharmacies’ Relationships with Physicians

The federal government has focused on compounding pharmacies and pharmacists for fraud and abuse investigations in recent years, and now the great state of Texas has joined in.

A Closer Look at AMP and Other Regulations: The Impact on Generics

On Thursday, February 18, please join Arent Fox partner Stephanie Trunk and Deloitte Senior Manager Rick Moore for a webinar that will break down the provisions of the AMP final rule and other regulatory guidance with a special focus on the needs and considerations of generic manufacturers. Topics will include:

The Final AMP Rule: An Overview for Stakeholders

On January 21, 2016, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited Final Rule implementing changes to the Medicaid Drug Rebate Program (MDRP) under the Affordable Care Act (ACA).