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Keeping you afloat amidst the rising sea of regulations

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.

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 the final rule. 

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.

HRSA Proposed Rule on Calculating the 340B Ceiling Price and Penalties Related to 340B Drug Discount Program

On June 17, 2015, the Health Resources and Services Administration (HRSA) published a long-awaited proposed rule setting forth revisions to the current regulations governing the 340B Drug Discount Program (340B Program) as set forth in 42 C.F.R. part 10 (Proposed Rule). Comments to the Proposed Rule are due August 17, 2015.

'Disguised' Discounts Lead Medco to Settle False Claims Allegations

On May 20, 2015, the United States Department of Justice (DOJ) announced that pharmacy benefits manager Medco Health Solutions Inc. (Medco) agreed to pay the government $7.9 million to resolve allegations that Medco’s arrangements with pharmaceutical manufacturer AstraZeneca violated the False Claims Act. Medco’s parent company, Express Scripts Holding Company, executed the settlement agreement on Medco’s behalf (the Settlement Agreement). AstraZenca entered into a similar settlement in February 2015, also for $7.9 million.  

Unsealed False Claims Act Suit Asserts that Reverse Payment Settlements Create Government Overpayments

Pharmaceutical manufacturers could face a new line of attack related to Hatch-Waxman reverse payment settlement agreements (so-called, "pay-for-delay" settlements). The FTC has challenged these agreements under the antitrust laws for over a decade, and the Supreme Court’s 2013 decision in FTC v. Actavis arguably created greater ambiguity for antitrust compliance. But newly unsealed federal litigation threatens to introduce even greater risk.

OIG Issues First Charitable Patient Assistance Program Advisory Opinion Incorporating New Guidance

On January 5, 2015, the Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion No. 14-11 (Advisory Opinion) addressing a charitable foundation’s request to provide cost-sharing assistance to financially needy patients diagnosed with either Crohn’s disease or ulcerative colitis, some of whom may be federal health care program beneficiaries.

OIG Issues Favorable Advisory Opinion to Pharmaceutical Manufacturer on Direct-to-Patient Discount Sales Program

On July 28, 2014, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued a favorable opinion concerning a drug manufacturer’s program to offer a certain branded drug via an online, mail order pharmacy directly to cash-paying customers at a discounted price.