The advance copy of the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs (HOPPS) final rule for calendar year 2018 (the Final Rule) was released on November 1, 2017. The official version of the Final Rule will be published in the Federal Register on November 13, 2017.
California Governor Jerry Brown signed two major pieces of legislation affecting the application and hiring process for nearly all employees. AB 168 prohibits employers from seeking salary history information about an applicant for employment, among its related provisions. AB 1008 “bans the box” on employers’ applications asking about criminal conviction history. Instead, employers will be able to inquire into, and consider, an applicant’s conviction history only after making a conditional offer of employment.
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.
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.
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.
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
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.