Health Care Counsel

Arent Fox's health care law blog offers news, analysis, and insights for the health care industry.

Health Care Counsel

Pharmaceutical & Device Compliance

The pharmaceutical and medical device industries are increasingly subject to intense government scrutiny. Arent Fox helps these companies navigate the rough waters by providing fraud and abuse risk assessments related to the sales and marketing of prescription drugs and medical devices under both federal and state fraud and abuse laws, as well as compliance program development, monitoring, auditing, and training tailored for the drug and device arena. We assist with “Sunshine Act” compliance, both under the federal Physician Sunshine Act and under state laws mandating reporting of advertising and marketing costs. We counsel companies related to all forms of patient assistance programs, including free goods, charities, and manufacturer-sponsored “coupon” or co-payment assistance programs. We also track state law developments relating to price reporting, registering of clinical trials and reporting of trial results, limitations on prescription data-mining and licensing or other oversight of field sales representations.

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Bristol-Myers Settlement Illustrates Continuing Enforcement Trend Against Allegedly Deceptive Promotion of Medical Products

Late last week, the Attorneys General of 43 states announced that they reached a $19.5 million dollar agreement with Bristol-Myers Squibb Company to settle allegations that the company engaged in deceptive trade practices with respect to the marketing of a drug intended for treating schizophrenia.

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US Attorney Announces Kickback and False Claims Act Settlement with Device Manufacturer BioTelmetry/MedNet

The US Attorney’s Office for the District of New Jersey recently announced an agreement with BioTelemetry Inc. to settle allegations that its recently-acquired subsidiary, MedNet, Inc., violated the Anti-Kickback Statue and False Claims Act by improperly inducing health care providers to use the company’s cardiac monitoring services.  

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Sellers Beware: California Adopts New Proposition 65 Warning Requirements

On August 31, 2016, California took a long-awaited step in publishing new major changes to the Proposition 65 warning regulations; the first of such amendments in more than a decade. The wholesale changes completely alter the “safe harbor” warning rules, creating a new set of obstacles for companies offering products or operating facilities in California. Although the new regulations are intended to increase clarity and decrease litigation, they may actually have the opposite effect. 
 

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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.

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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.

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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.

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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.

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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.
 

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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

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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.  

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ABOUT ARENT FOX LLP

Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.