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Keeping you afloat amidst the rising sea of regulations

Vermont Publishes First List of Pharmaceuticals for Transparency Reporting

Vermont has published the first list of pharmaceutical products for which manufacturers are required to submit annual price transparency reports. The list is available on the Vermont Office of Attorney General website. Prescribed forms are available for reporting there as well. Reports are due on or before October 1, 2016.

CMS Releases Covered Outpatient Drug Final Rule FAQs

On July 6, CMS issued a set of Frequently Asked Questions to respond to questions raised by the Covered Outpatient Drug Final Rule that was published on February 1, 2016.  The FAQs can be accessed here; our January 28 article analyzing the final rule can be accessed here and our analysis of the delayed implementation of the revised 5i AMP methodology and 70/30 test can be found here.

Vermont the First State to Require Pricing Justification from Drug Manufacturers

Rising prescription drug costs have been big news this year, and states are beginning to respond.  On June 3, 2016, the Governor of Vermont signed into law bill S.216, “An act relating to prescription drug formularies” (the “Law”).  The Law is designed to understand the drivers of rising prescription drug costs, and, among other things, will require all health insurers offering plans under the Ver

Texas Adopts NADAC and Eliminates Some Manufacturer Reporting

Texas Health and Human Services Commission (HHSC) has finally issued final regulations transitioning to the use of the National Average Drug Acquisition Cost (NADAC) to establish Medicaid ingredient cost reimbursement instead of utilizing manufacturer-reported prices.   As such, effective May 16, 2016, pharmaceutical manufacturers will not be required to provide monthly calculations of Average Wholesale Price, Price to Wholesaler/Distributor, Direct Price to Pharmacy, Direct Price to Chain Pharmacy and Direct Price to Long Term Care Pharmacy to HHSC beginning in June 2016. 

Don’t Discount the Discounts: Pfizer and Wyeth Reach Settlement Over Medicaid Drug Pricing Allegations

The Department of Justice recently announced it has reached a more than $780 million settlement with Pfizer Inc. and its subsidiary Wyeth to resolve allegations that from 2001 through 2006, Wyeth reported false prices to the government on two of its proton pump inhibitor drugs, Protonix Oral and Protonix IV, in violation of the False Claims Act.

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.