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Keeping you afloat admidst the rising sea of regulations

No Longer an Orphan: Drug Manufacturers Claim Victory in Recent 340B District Court Ruling

On October 14, 2015, the United States District Court for the District of Columbia (the Court) issued a ruling which could have significant positive implications for those drug manufacturers unhappy with a particular Department of Health and Human Services Health Resources and Services Administration’s (HRSA) interpretive rule – namely, the July 2014 rule extending deeply discounted prices under section 340B of the Public Health Services Act (PHSA)  to certain entities for “orphan drugs,” when used by qualifying patients for treatment of conditions beyond those that originally qualified the

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!

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. 

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.

UPDATE: CMS Provides New Guidance to Hospitals on How to Settle Inpatient Appeals

Representatives for the Centers for Medicare and Medicaid Services (CMS) held a conference call on October 9, 2014 to address ongoing questions and clarify the requirements for hospitals that want to settle the inpatient-status claims whose denials they have appealed. As discussed in a recent Arent Fox client alert,1 the CMS settlement offer will pay hospitals 68 percent of the amount at issue.

Local Drug Take-Back Law Creates Regulatory Burden for Manufacturers

On September 30, 2014, the US Court of Appeals for the Ninth Circuit unanimously held that the first-in-the-nation Safe Drug Disposal Ordinance passed by Alameda County, California is constitutional.