A Cry for Help? FDA Bares Concerns in NEJM

Bipartisan bill HR 2474 the Medical Product Review Harmonization Act of 2017 was submitted by California U.S. House of Representatives Mimi Walters and Ami Bera on May 16, 2017. If passed the bill will make certain Class II medical devices quicker and easier to get FDA clearance—including removing the need for redundant, duplicative review processes.

Jack Zigler keeps tracking his ProDisc patients, now 12 years post FDA approval. Just as he found at 3 years, 5 years and 7 years post approval, LADR is superior to fusion.  And cheaper.  Yet, on May 1, 2017 United Healthcare cited no long term data to label LADR “unproven.” Such a monumental mistake.  Read on.

Spook technology stolen from U.S. spy agencies was used by hackers in a phishing cyberattack that crippled Britain’s National Health Service and computers worldwide. Outdated healthcare computer systems make healthcare systems easy targets. Read about this attack and see what you can do to keep patients safe.

Orthopedics This Week calls for a change in the economic framework for the clinical study process globally. The current system is undermined by systemic bias, lack of reproducibility and scalability. The causes come from multiple factors, many of which are non-corporate. It is time to address these issues.

Once upon a time lumbar arthroplasty was the most innovative and exciting development in spine surgery. Thirteen years ago the procedure hit a reimbursement wall. That was then, this is now. The resurrection of TOPS is the latest sign that lumbar arthroplasty has a second wind. 

Millions of patients have evaluated their hospital, physician and nurse experience by way of the HCAHPS survey. Patients seem happy. But CMS isn’t. And poorer hospitals are calling foul. We checked with the expert about all this and read a handful of new studies. Conclusion: HCAHPS is a very good, albeit not perfect, thing.

A bill is pending to amend the Internal Revenue Code’s Public Health Service Act (PHSA). The Budgeting for Opioid Addiction Treatment Act (BOAT) potentially places a one penny per milligram excise tax on most opioid prescriptions, with the revenue earmarked for opioid treatment programs.

The most senior FDA executives went public with their worries, frustration even, we suspect, impotence regarding the plethora of stem cells therapies in the market last November. And that article, which appeared in the New England Journal of Medicine just keeps growing in influence. Here is what Celia Whitten, Peter Marks and Robert Califf said.

Kern Singh, M.D. is advancing the science of spine with the establishment of the MISSG. New research suggests that we need to look deeper into RA to treat it. Ted Davis, 25-year veteran of life sciences, takes helm at Active Implants.

A private Brazilian insurance group claims U.S. orthopedic and other implant device makers and the U.S. government allegedly violated the Foreign Corruption Act. In numerous private lawsuits, the group alleges a “Prosthetic Mafia” gorged payers.