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Keeping you afloat amidst the rising sea of regulations

Medical Providers & Concepts of Authority Article

The world of health care reimbursement can involve many different players on the payer side. Group health plans and health insurers are well-known players, but networks, administrators, repricers, consultants, and others may enter the scene as well. Knowing which entities can be held liable for payment, and how, may be critical to a medical provider’s ability to secure the payment to which it is entitled. 

The Healthy Indiana Plan: A National Model for Medicaid Reform?

Arent Fox Health Care Partner David Greenberg and Associate Sean Clerget recently published an article in Bloomberg Law discussing health care reform, specifically focusing on the Medicaid program and how innovations currently in place in Indiana may serve as the model for Medicaid reform under the current administration.   

FDA Issues Comprehensive Tissue Product Regulatory Framework

On November 16, 2017, FDA announced a comprehensive regenerative medicine policy framework to provide additional clarity regarding existing and future tissue regulation. This framework includes a final guidance document establishing FDA’s interpretation of integral terms relating to regulation of certain tissue products, as well as draft guidances regarding the statutory designation of regenerative medicine advanced therapies (RMATs) authorized under the 21st Century Cures Act.   

Just in Time for the Holidays: California Agencies Propose Emergency Regulations for Temporary Cannabis Licenses

With less than 45 days until the January 1st implementation of Proposition 64 (the proposition that legalized cannabis in California) and the effective date for the Medicinal and Adult-Use Cannabis Regulation and Safety Act (an act that regulates cannabis), the California agencies given licensing authority under the law posted their proposed emergency regulations for commercial medicinal and adult-use cannabis.

HOPPS 2018 Final Rule Released, Confirming Changes to Medicare Part B Drug Reimbursement for Drugs Purchased Under the 340B Program

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 Bans Inquiries Into Applicant’s Salary History, “Bans the Box” On Criminal History Inquiries

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.

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.