Health Care Counsel

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

Health Care Counsel

Prescription Drug Pricing & Government Price Reporting

Arent Fox is one of only a handful of US firms that can provide sophisticated counsel to the prescription drug industry on the full range of complex pricing issues, including AWP and WAC reporting to the compendia, ASP reporting to Medicare, AMP and Best Price reporting to Medicaid, ceiling and sub-ceiling price reporting to support the Public Health Service 340B program, and non-FAMP and FCP reporting to FA/FSS. We also assist pharmaceutical manufacturers in navigating the Coverage Gap Discount Program under Medicare Part D, NADAC, and the AAC methodologies currently being adopted by state Medicaid programs. Our advice reflects experience gained from supervising government pricing systems audits, handling restatements and voluntary disclosures with CMS, the Office of Pharmacy Affairs at HRSA and the VA, and representing clients facing enforcement actions tied to their price reporting obligations.

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

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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!

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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

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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.

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'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.
 

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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.

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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.

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OIG Proposes New Safe Harbors to Anti-Kickback Statute

Opens the Door to Pharmacy Rewards Programs for Federal Health Care Program Beneficiaries, Among Other Things
 

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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.

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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.

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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.