The FDA has just issued new opioid standards and a stark warning about a potentially addictive herbal pain relief drug known as Kratom. Both will affect the practice of treating musculoskeletal pain. They are: 1. New Standards for Approving New Opioids On June 20, FDA issued a draft of guidance for opioid manufacturers on how […]
Big insurance flexed its political muscles July 11 on legislation to deal with surprise medical billing (which was called “balance billing” until it became a hot political potato), persuading the Health Subcommittee of House Energy and Commerce to issue a bill which would take money out of the pockets of non-network physicians, especially surgeons and […]
Dr. Sethi announced June 2 that he’s running for the open U.S. Senate seat of Tennessee Republican Lamar Alexander.
President Trump ordered the Department of Health and Human Services (HHS) on June 24 to propose a regulation within 60 days requiring hospitals to “publicly post standard charge information, including charges and information based on negotiated rates and for common or shoppable items and services.” If that language seems vague, that’s because it is. “Prices […]
Are criminal charges in the air for Parker “Pete” Petit? He raised the question himself. Are MiMedx’s orthopedic products-in-development gone for good? Or are they merely in need of more testing and development, leading to a place in what is widely seen as a transformative, huge market for new, tissue-regeneration-based orthopedic treatments? Will the company’s […]
Physicians, you’re doing your part to fight the opioid crisis. In fact, a new report from the American Medical Association (AMA) says that to a degree, physicians are over-doing the response. One clear implication of this AMA report is that while prescribing may or may not have been a significant trigger for the nation’s opioid […]
The American Association of Orthopaedic Surgeons (AAOS) is applauding House and Senate passage of a disaster preparedness bill and is taking due credit for shepherding a little-noticed provision, which boosts military-civilian cooperation in orthopedics, through Congress. The bill—which is not the big disaster relief funding legislation signed by President Trump on June 6—is called the […]
If money talks, the stock market said this on May 30 about MiMedx, the embattled wound-care allograft company: “Welcome, Prescience Point Capital Management Inc. Welcome, Dr. Wilsey. Uh, Parker (Pete) Petit…not so welcome.” Here’s What Happened The background: As followers of this never-ending story know MiMedx’s founder and former CEO Pete Petit was booted out […]
The Food and Drug Administration (FDA) announced May 30 that it has set up a public docket for comments on its proposal that immediate-release, solid-form, oral-dosage opioids be dispensed to outpatients in blister packs with fixed quantities. The FDA believes that fixed-dosage blister packs of five, 10, and 15 pills “could reduce the amount of […]
The deadline is June 26 for submitting a pre-application to possibly win an orthopedics research grant from the Peer-Reviewed Orthopaedic Research Program (PRORP), a Department of Defense (DOD) research program mandated by Congress. The deadlines and details of the announcements are far different from those of an earlier DOD announcement of the same program we […]
In its latest not-quite-enforcement action against sellers of human cell and tissue products (HCT/Ps) without biologics licenses or in violation of the 361 HCT/P rules, the Food and Drug Administration (FDA) announced May 30 that it had sent an “untitled letter” to an Arizona company called R3 Stem Cell LLC and its chief executive, David […]
The Food and Drug Administration (FDA) has issued a warning letter to Orchid Orthopedic Solutions LLC, citing both manufacturing defects and possible sources of infection in its processes for adding bone-ingrowth-stimulating coatings to orthopedic implants. Orchid, majority-owned by European private equity firm Nordic Capital Fund IX, manufactures its own implants and instruments at facilities around […]
After the stock market closed Thursday, May 23, the MiMedx board of directors set fire to ousted CEO Parker (Pete) Petit’s blueprint for retaking control of the company, accusing him and his management team of a variety of legally dubious accounting and employee management behaviors. Buried deep in the report is a poison pill targeting […]
The Food and Drug Administration (FDA) published on May 24 a Class I recall of monitors often used in total joint arthroplasty and trauma cases to measure the levels of patient heart and respiratory functions during surgery. The monitor’s manufacturer is Edwards Lifesciences LLC and the product is the EV1000 clinical platform. The recall notice […]
Both the American Academy of Orthopaedic Surgeons (AAOS) and the North American Spine Society (NASS) have praised an extremely rare tri-partisan Washington initiative (Democrats and Republican in Congress; President Trump) to act on the sometimes-huge surprise medical bills patients receive after surgery. At the same time, Trump was expected to issue an executive order, possibly […]
Did ousted MiMedx CEO Pete Petit just bring a gun to a knife fight? In a stunning turn of events, Petit and his legal team filed another proxy statement seeking to force a second board election. Amidst all the drama at the board, how is the company itself doing? That remains the deepest mystery of all.
A new study says that prolonged opioid use correlates to the number of morphine milligram equivalents (MMEs) prescribed at discharge after an operation, not the type of opioid, and that many prescribers are failing to correctly calculate dosages. “One of the frequent myths we encounter among clinicians is that some types of opioids, such as […]
Your patient cries out, “Doc, I’m in pain.” The government steps in and tells you to follow its 948-word pain management guideline. That’s the short version, from the executive summary. The full set of recommendations is 112 pages. This final set of guidelines, “Pain Management Best Practices Interagency Task Force Draft Final Report on Pain […]
A Pennsylvania court has reaffirmed the legality of an old, rarely used Food and Drug Administration (FDA) power: the “inspection warrant.” The court said in its April 17 ruling that the FDA has the authority to get a court-ordered warrant to search your facilities and your computers without demonstrating probable cause that a crime has […]
The Food and Drug Administration (FDA) announced May 1 that one lot of the injected form of the analgesic Ketorolac Tromethamine, in 60mg/2mL (30mg per mL) being recalled nationwide by Sagent Pharmaceuticals, Inc. because of heightened concerns of the risk of blood infections which could cause septic shock and possible death. The affected lot number, […]
The Food and Drug Administration (FDA) announced April 18 that it is proposing new guidelines for pre-market testing of Nitinol, a titanium-nickel alloy widely used in medical implants. The FDA said nothing has been found to be wrong with devices made from this metal. Then why this action? The April 18 draft guidelines are the […]
One of the largest chains of pain clinics in the United States just settled a serious whistle blower lawsuit. While the defendants did not admit any wrong doing, the complaint makes for very, sober reading and is a cautionary tale for all clinics, not just pain clinics.
The Brainlab Spine & Trauma 3D Navigation software, which controls the Brainlab Spine & Trauma Navigation System, has faults which could cause a surgeon to see the operating space incorrectly and cause serious injury or death to patients, the Food and Drug Administration (FDA) announced April 15. The software is being recalled “due to the […]
In a new development in the continually-evolving federal policies toward opioids, the Food and Drug Administration (FDA) has issued labeling changes for prescription opioids which instruct physicians to taper, rather than cut off or cut down, opioid prescriptions—and prescribing detailed instructions to physicians on how to do so. In making the policy change, the FDA […]
MiMedx’s shareholder meeting is on June 17, 2019. Every shareholder should attend, for the entertainment value. Former CEO Pete Petit, will fight to get back in the company. The Feds are ramping up their investigations. Short sellers are raging. MiMedx, the journalistic gift that keeps on giving.
Stepping up its campaign against non-compliant human cell tissue products (HCT/Ps), the Food and Drug Administration (FDA) on April 3 cautioned 20 companies—which it refused to name when we asked—that their products are non-compliant and may be violating FDA regulations. In the same announcement, FDA Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research […]
Physicians may have to work harder and fight the federal bureaucracy to write new prescriptions for opioids covered under Medicare Part D under policies issued by the Centers for Medicare and Medicaid Services (CMS) on March 28. “The new opioid policies include improved safety alerts at the pharmacy for Part D beneficiaries who are filling […]
Food and Drug Administration (FDA) Commissioner Scott Gottlieb said in a March 26 announcement that there could be unpredictable “spot” shortages of hundreds of sterile medical devices and instruments due to the recent closing of a Sterigenics sterilization operation in Illinois and the coming closing of another plant owned by Viant in Michigan. Of the […]
After more than two years of deliberations, the Food and Drug Administration (FDA) issued a rule on April 1 designating posterior cervical screw systems as Class II medical devices with a set of special controls. The rule is to go into effect May 1. The prior status of these systems from 2001 until this final […]
Let the Games Begin. While many of Trump’s 2020 budget proposals are likely dead on arrival, some are not – including proposals which would cut hospital and physician pay. AAOS has weighed in and liked the proposed revised Stark Law rules and site cost neutrality. Here are the details.
The 1,500-member American Alliance of Orthopaedic Executives (AAOE), which represents the people who run the business end of orthopedic practices, has accused electronic health record (EHR) vendors of “questionable” pricing tactics. The group wants the federal government to crack down by establishing a “data bill of rights” for medical practices in dealing with EHR vendors. […]
A Defense Department (DOD) program called the Peer Reviewed Orthopaedic Research Program (PRORP) announced on March 21 that potential investigators can sign up for a chance to win millions of dollars in research grants at a website called eBRAP (Electronic Biomedical Research Application Portal). The grant offers are intended “to support the most significant gaps […]
Performing orthopedic surgery is an athletic endeavor – and it comes with athletic injuries. In fact, the rate of injuries among orthopedic surgeons’ rivals police work and construction. A recent survey of spine surgeons was particularly shocking. Here are the details.
Back in 2013, a study funded by Stryker Corporation reported that all (100%) enrolled patients receiving its porous, 3D-manufactured primary Tritanium acetabular cup were experiencing no problems and the cups were performing well two to four+ years postoperatively. That was then. Here’s now. Three independent studies published between February 2017 and November 2018 raise questions […]
In the wake of Stryker’s recall of the Instructions for Use of its 3D Tritanium lumbar cage, questions are being raised about the strength and durability of porous 3D implants generally.
