Tag Archives: EpsteinBeckerGreen

New Federal Laws Banning “Gag Clauses” in the Pharmacy

On October 10, 2018, President Donald Trump signed into law the “Know the Lowest Price Act” and the “Patients’ Right to Know Drug Prices Act,” which aim to improve consumer access to drug price information by banning gag clauses. The Trump administration previously announced its intention to enact this legislation in its May 2018 Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs and will likely point to these new federal laws as affirmation of its commitment to drug pricing reform that favors patients and consumers.

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FDA Addresses Allegations of “Gaming” The Generic Drug Approval Process Through The Use of Citizen Petitions

On October 2, 2018, FDA Commissioner Scott Gottlieb released a statement announcing new agency actions to further deter “gaming” of the generic drug approval process through the use of citizen petitions.  Among these actions, the most significant was the issuance of a revised draft guidance on citizen petitions subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), published on the same day.  The stated goal of this revision was to create a more efficient approach to 505(q) petitions and to allow the Agency to focus reviewer resources on scientific reviews.

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OCR and ONC Update Their Security Risk Assessment Tool

On October 16, 2018 the Department of Health and Human Services Office for Civil Rights (“OCR”) and the Office of the National Coordinator for Health Information Technology (“ONC”) announced an update to their previously provided Security Risk Assessment Tool.  According to ONC and OCR, the “tool is designed to help healthcare providers conduct a security risk assessment” as required under the HIPAA Security Rule.  ONC states that the updated tool includes additional features such as:

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FDA Issues Draft Guidance on Management of Cybersecurity in Medical Devices

The FDA issued a new Draft Guidance today to ensure medical devices – an increasing potential target for hackers – are better protected from unauthorized digital access.

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FDA Releases Draft Guidances to Promote Clinical Trial Design Efficiency

On September 28, 2018, the U.S. Food and Drug Administration (FDA) released two draft guidances for industry. The purpose, according to FDA Commissioner Scott Gottlieb, M.D., is to modernize the approach to clinical trial design in efforts to (1) make clinical trials more efficient while maintaining patient safety and (2) increase the amount of information concerning product safety and benefits. The two draft guidances are entitled: “Master Protocols – Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics” and “Adaptive Designs for Clinical Trials of Drug and Biologics.” This is the second of the two-part blog series describing the updates to the agency’s recommended approach to incorporating master protocols in clinical trials of new drugs and biological products for the treatment of cancer. The first of the two-part blog series described FDA’s recommended considerations to “adaptive designs” used in clinical trials.

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New Draft Guidance on Adaptive Designs for Clinical Trials

Two draft guidances issued together late last month seek to increase both clinical trial efficiency and the amount of information that is available about a drug’s safety and benefits.  The two draft guidances address, respectively, adaptive designs and master protocols.  This blog post discusses FDA’s recommendations for adaptive designs; master protocols will be addressed in a subsequent blog post.

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Court Finds ACLA Claims Precluded, CMS PAMA Rules Stand

The American Clinical Laboratory Association (“ACLA”) challenged the final rules promulgated by the Department for Health and Human Services (“HHS”) pertaining to how the Medicare Clinical Laboratory Fee Schedule (“CLFS”) payment rates are established for laboratory services (Am. Clinical Lab. Ass’n v. Azar, No. 17-2645 ABJ, 2018 U.S. Dist. LEXIS 161639, 2018 WL 4539681 (D.D.C. Sept. 21, 2018)). The U.S. District Court of the District of Columbia granted HHS’ motion for summary judgment to dismiss the complaint after concluding that the court lacked subject matter jurisdiction to hear the case. This is a significant set-back for the laboratory industry that has been fighting against the reductions in Medicare reimbursement under the new payment methodology, but it is not the end of the road.

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Medicare Advantage Downstream Provider Settles Risk Adjustment False Claims Allegations

The Department of Justice (DOJ) announced this week that it has entered into a settlement agreement with Davita Medical Holdings (Davita) for $270 million dollars to resolve certain False Claims Act liability related to Medicare Advantage risk adjustment payments.

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D.C. Council Gives Initial Approval to Legislation Overturning Voter-Approved Elimination of Tip Credit Continue Reading…

In our July 9, 2018 post we reported that a seven-member majority of the D.C. Council had introduced a bill, Bill 22-0913 (Tipped Wage Workers Fairness Amendment Act of 2018) to repeal Initiative 77, an initiative that District of Columbia voters approved on June 27, 2018 that would incrementally increase the minimum cash wage for tipped workers to $15.00 per hour by July 1, 2025 and effectively eliminate the tip credit starting July 1, 2026. We also noted that no further action would occur until this Fall due to a two-month summer recess.

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DOJ Finally Chimes In On State of the Website Accessibility Legal Landscape – But Did Anything Really Change?

As those of you who have followed my thoughts on the state of the website accessibility legal landscape over the years are well aware, businesses in all industries continue to face an onslaught of demand letters and state and federal court lawsuits (often on multiple occasions, at times in the same jurisdiction) based on the concept that a business’ website is inaccessible to individuals with disabilities.  One of the primary reasons for this unfortunate situation is the lack of regulations or other guidance from the U.S. Department of Justice (DOJ) which withdrew long-pending private sector website accessibility regulations late last year.  Finally, after multiple requests this summer from bi-partisan factions of Members Congress, DOJ’s Office of Legislative Affairs recently issued a statement clarifying DOJ’s current position on website accessibility.  Unfortunately, for those hoping that DOJ’s word would radically alter the playing field and stem the endless tide of litigations, the substance of DOJ’s response makes that highly unlikely.

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