Joel English, Managing Partner at BVK, presented further insight on health brand architecture at the SHSMD annual conference last week in Seattle. Brand architecture defined.  Brand architecture is how all the pieces of a brand and its value promise fits together.  Healthcare brands can include many brands components.  Joel provided the following example of a fictitious health brand ecosystem: Driver Brands:  Anchor University Hospital – part of True Health Strategic Brands: Anchor Medical Group…
The Centers for Medicare & Medicaid Services (CMS) has proposed revising its rules governing the process Medicare beneficiaries, providers, and suppliers use to appeal adverse determinations regarding claims for Medicare Part A and Part B benefits or determinations for Part D prescription drug coverage.  According to CMS, the revisions “would help streamline the appeals process and reduce administrative burden on providers, suppliers, beneficiaries, and appeal adjudicators.” Among other things, the proposed rule would: Allow appellants…
It has now been one month since the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) sent its proposed information blocking rule to the Office of Management and Budget (OMB) for required review. We expect OMB to approve the much-anticipated proposed rule and ONC to release it soon with the usual opportunity for public comment. While we wait, there are some things that health information…
On Friday, the head of the Department of Justice criminal division, Brian Benczkowski, released a memorandum regarding the selection of monitors in criminal division matters.  The new policy was announced to a small audience at New York University School of Law.  The memorandum supersedes guidance contained in Lanny Breuer’s memorandum from 2009 laying out the Department of Justice’s monitor selection process. Mr. Benczkowski commented when announcing the new policy that “the imposition of a compliance monitor should be…
Sick with Legionnaires’ disease? Call (612) 337-6126 Elliot Olsen has regained millions of dollars for people harmed by Legionnaires’ disease. If you or a family member contracted Legionnaires in Champaign County, please call (612) 337-6126 for a free consultation. Six cases of Legionnaires’ disease have been confirmed in Illinois’ Champaign County since September 15, according to the Champaign-Urbana Public Health District (C-UPHD). The Illinois Department of Public Health (IDPH) said investigators believe the county residents…
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
Here’s a post by Dr. Katie Clow from our sister site, PetsAndTicks.com. Today, we received our 400th tick submission (actually, 401 to be exact). Does that sound like a large or a small number? Although there’s no real answer to that question, to me it seems like a pretty small number. At this time last year, when the Pet Tick Tracker ran through the Worms and Germs blog, over 1400 submissions had been received. So,…
Sick with Legionnaires’ disease? Call (612) 337-6126 Elliot Olsen has regained millions of dollars for people harmed by Legionnaires’ disease. If you or a family member contracted Legionnaires in this lower Washington Heights outbreak, please call (612) 337-6126 for a free consultation. The second Legionnaires’ disease outbreak of 2018 has now affected 20 residents of lower Washington Heights since the end of September, according to the NYC Department of Health and Mental Hygiene (DOHMH) website. Although…
KKR has announced it has completed its acquisition of Envision Healthcare Corp. The deal, which was previously announced in June, is valued at $9.9 billion. Kohlberg Kravis Roberts (KKR) & Co., based in New York, considers investments in all industries, including healthcare. The firm is publicly traded under the ticker symbol KKR. It prefers to invest in a range of debt and public equity investing and may co-invest, seeking a controlling ownership of…
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. An adaptive design is a “clinical trial design that allows for prospectively planned modifications to…