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.


OMB Clears Final Average Manufacturer Price (AMP) Rule

The Medicaid Covered Outpatient Drugs Final Rule completed review by the Office of Management and Budget late on Friday, December 11. It has been almost 4 years since publication of the 2012 Proposed AMP Rule aimed at implementing changes to the AMP calculation as set forth in the Affordable Care Act. The Arent Fox team will promptly post once the Final AMP Rule is release and subsequently issue a comprehensive Client Alert. Stay tuned!


Texas Medicaid Transitioning to National Average Drug Acquisition Cost (NADAC)-Based Pharmacy Reimbursement

The October 30, 2015 Texas Register contained a proposed regulation published by the Texas Health and Human Services Commission (HHSC) that would replace pharmacy reimbursement under the Texas fee-for-service Medicaid program, currently based on Estimated Acquisition Cost, with Acquisition Cost based on NADAC, Long Term Care Acquisition Cost and Specialty Pharmacy Acquisition Cost.  In addition, the proposed regulation would repeal burdensome price reporting requirements for drug manufacturers


CMS Reminds States of Coverage Obligations for Hepatitis C Drugs

On November 5, 2015, the Center for Medicaid and CHIP Services, a division of the Centers for Medicare & Medicaid Services (CMS), issued a Medicaid Drug Rebate Program notice (the Notice) to state Medicaid contacts emphasizing appropriate access to, and coverage of, direct-acting antiviral (DAA) drugs used to treat individuals with the hepatitis C virus (HCV).


Pharmaceutical Manufacturers Should Take Note of Bipartisan Budget Act

On November 2, 2015, President Obama signed the Bipartisan Budget Act of 2015 into law. The two year budget deal increases overall spending limits and prevents the United States from defaulting on its debts by suspending the debt limit through March 2017. The Act also contains several provisions that will have a direct impact on the pharmaceutical industry. Specifically, manufacturers should take note of the following:


Long-Awaited 340B Program Guidance Now Available for Comments: What Stakeholders Need to Know


HRSA Releases Long Awaited Draft 340B Guidance

An advance copy of the long-awaited 340B Drug Pricing Program Omnibus Guidance has been released by the Health Resources and Services Administration. The official version is scheduled to be published in the Federal Register on August 28, 2015. Arent Fox’s Health Group attorneys are reviewing the release, and an in-depth analysis will be posted to Health Care Counsel Blog shortly. Stay tuned!


US District Court Affirms First Amendment Protection of Off-Label Drug Promotion

On August 7, 2015, the US District Court for the Southern District of New York issued a significant decision concerning FDA’s regulation of off-label promotion of approved drugs. The decision, Amarin Pharma Inc. v United States Food and Drug Administration (August 7, 2015), granted Amarin’s motion for preliminary injunction, prohibiting FDA from prosecuting the company for making truthful and not-misleading statements to physicians about unapproved uses of one its products. This decision grows out of the landmark decision in United States v. Caronia, 703 F.3d 149 (2d Cir.


OIG Issues Favorable Advisory Opinion to Pharmaceutical Manufacturer Related to a Free Starter or Bridge Program

On August 5, 2015, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No.


Long-Anticipated Average Manufacturer Price Final Regulations Being Reviewed by the Office of Management and Budget

On August 4, 2015, the long-awaited final rule from CMS implementing the Affordable Care Act changes to the calculation of Average Manufacturer Price (AMP) went over to the Office of Management and Budget (OMB).  OMB has up to 90 days to review a rule before it is published.  As such, we anticipate the final rule will be issued before November 4, 2015.  Manufacturers should stand ready to promptly analyze the content of final rule, and AMP methodologies and Government Pricing systems will need to be modified and updated to ensure their products’ AMP calculations comply with t


The Internal Threat: Cyber Security and Medical Devices

A recent blog post in the IEEE Spectrum, “Hackers Invade Hospital Networks Through Insecure Medical Equipment,” focused attention on something known for a while: medical devices can open a door to hospital networks, wreaking all sorts of havoc.


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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.