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Keeping you afloat amidst the rising sea of regulations

Time to Refine Your BAA - Don't Follow the Flock!

* The following alert was originally published in California Healthcare News (CHN). To read it on the CHN website, click here.

FDA Requires Pharma Companies to Certify Drug Listing Info

In August 2016, the Food and Drug Administration issued a final rule to update and clarify the agency’s drug registration and listing regulations. The rule made some fairly substantial changes even though the rule became effective last November, and drug companies may just now start to feel the impact of some of the rule’s requirements.

2017 Survey of Data Breach Notification Statutes

We are pleased to provide you with the new, 2017 version of the Arent Fox Survey of Data Breach Notification Statutes. This version updates the Survey that we created and circulated last year, including new statutes and amendments that have been enacted since August of 2016. This Survey focuses on the data breach notification statutes of the states and territories within the US, and should be a useful tool and guide for data security planning and response purposes for your company.

340B Program Participants Take Note: New Technical Changes Are Coming

On September 5, 2017, the Health Resources and Services Administration announced the transition to a new Office of Pharmacy Affairs Information System (340B OPAIS), which will impact and modernize the current 340B covered entity database and will also impact the mechanism through which drug manufacturers report 340B drug prices to HRSA. To educate both covered entities and drug manufacturers about the details of the new 340B OPAIS, the Office of Pharmacy Affairs will be conducting two public webinars later this month.

Can a Healthcare Plan Dictate Where a Medical Provider May Sue It?

The issue of where a medical provider with an assignment of benefits may sue an ERISA-governed healthcare plan for unreimbursed medical care is important.

Uncertainty Becomes the Norm…for 340B Rulemaking, at Least

On August 21, 2017, the Health Resources and Services Administration (HRSA) published a proposed rule (the Proposed Rule) that would entertain even further delays of the implementation of a January 5, 2017 Final Rule (the Final Rule) regarding calculation of 340B ceiling prices and the imposition of civil monetary

FDA and Duke University to Explore Expanded Use of Real-World Evidence for Drugs in Public Workshop

On September 13, 2017, FDA and the Duke-Robert J. Margolis, MD Center for Health Policy will bring stakeholders to discuss a variety of topics related to the use of real-world data (RWD) and real-world evidence (RWE) in drug development and decision making. Topics in general will include an update on FDA’s activities to address the use of RWE in regulatory decision and development of a framework for handling challenges related to accepting RWE. Panelists are expected to discuss opportunities to improve data development activities, study designs, and analytical data to create robust RWE.

California State and Local Cannabis Rules Take Different Paths

Over the past month, California has been a veritable hotbed of activity regarding the regulation of cannabis for both medical and adult use. Most notably, on June 27, Governor Jerry Brown signed into law the Medicinal and Adult-Use Cannabis Regulation and Safety Act to harmonize and reconcile the state’s requirements for medical and adult use, which previously imposed different standards based on the cannabis’ use.

Phil English and Byron Dorgan Quotes on Healthcare in Fierce Healthcare Article

Arent Fox former Senator and Congressman, respectively, discussed a newly released report that shows the benefits of group purchasing organizations on the cost of health care. The report is the 11th annual edition from The Healthcare Group Purchasing Industry Initiative (HGPII). Phil English, an Arent Fox Senior Government Relations Advisor, serves as the HGPII national coordinator while Byron Dorgan, an Arent Fox Senior Policy Advisor, is the national co-coordinator.

HOPPS Proposed Rule Recommends Big Changes to 340B Program

The Centers for Medicare & Medicaid Services (CMS) has released its annual proposed update to the hospital outpatient prospective payment system (HOPPS) for calendar year 2018 (the Proposed Rule). The official version of the Proposed Rule will be published in the Federal Register on July 20, 2017, and comments are due on September 11, 2017.