FDA Issues Guidances for Industry on Social Media

Today's article shared from Thomas Abrams

Ongoing changes in technology transform medical products – and the ways that both patients and health care providers learn about those products. In today’s world, in addition to traditional sources of medical product information, patients and health care providers regularly get information about FDA-regulated medical products through social media and other Internet sources, and those technologies continue to evolve. But regardless of the Internet source used to communicate about medical products, the public health is best served by clear, accurate, truthful and non-misleading information about them.

That’s why the agency has proposed two draft guidances for industry with recommendations to help manufacturers and their representatives accurately communicate online about prescription drugs and medical devices.

These documents strive to ensure that the information provided by drug and device companies is accurate and will help patients to make well-informed decisions in consultation with their health care providers.

Our first guidance provides recommendations for the presentation of risk and benefit information for prescription drugs or medical devices using Internet/social media sources with character space limitations, such as Twitter and the paid search results links on Google and Yahoo. These recommendations address the presentation of both benefit information and risk information in this setting. We understand that...

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IMR: DWC Get Out of the Way

Today's post was shared by WorkCompCentral and comes from daviddepaolo.blogspot.com

What is the purpose of California's Independent Medical Review? I have to ask myself this question in light of the most recent proposed changes to Utilization Review/IMR rules published by the Division of Workers' Compensation (a whopping 75 pages long, albeit inclusive of all changes since origin). What causes me to pause is that the new amendments would allow a medical reviewer to, “issue a determination as to whether the disputed medical treatment is medically necessary based on both a summary of medical records listed in the utilization review determination,” and additional documents submitted by the employee or requesting physician. In addition, the latest amendments reverse the order in which documentation is mandated - prior versions of the regulations said the claims administrator shall provide the documents. This version provides that the IMR entity shall RECEIVE documents. I don't know why this was done, but to me it seems bass-ackwards. Finally the pending amendments would allow the DWC administrative director to determine that an IMR decision is not valid because the case should not have been deemed eligible for review in the first place. The rules would say the director can vacate an IMR determination at any point unless an appeal has been filed with the Workers' Compensation Appeals Board or the time to file an appeal has expired. IMR was statutorily authorized by Labor Code section 4610.5, added via SB 863. LC 4610.5 provides a list of the documents...

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Wah, Wah, Wah

Occupational disease claims present difficulty in the delivery of medical care. Today's post was shared by WorkCompCentral and comes from daviddepaolo.blogspot.com

At least that's the message that I got out of the latest study from researchers at National Institute for Occupational Safety and Health in their study just published by the Journal of Occupational and Environmental Medicine. According to them, accepted workers' compensation claims that do not result in medical payments could be costing group health insurers at least $212 million a year because folks who don't get their treatment through work comp for their work injuries or illnesses do so through their group health provider. Claims that do not result in medical payments through work comp are referred to as "zero-cost claims" in the study. The researchers' analysis of more than 12,000 claims from 2002 through 2005 revealed that 15.9% of the claims were zero-cost claims. Claimants with zero-cost claims were more likely to use group health insurance services and incur more group health costs. "In the three months before an occupational injury, 53.9% of workers with positive-cost workers' compensation medical claims and 61.6% of workers with zero-cost workers' compensation medical claims used the outpatient group health insurance at least once," the study says. "Within three months after an occupational injury, group health insurance utilization for outpatient services increased to 61.2% and 74.1% for workers with positive- and zero-cost workers' compensation medical claims, respectively." In addition, one of the study's most significant findings...

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Hip Replacement Lawsuit: ASR Settlement ($2.5 Billion) Benefits Announced

The settlement terms of the ASR HIp Implant lawsuit have been announced:

The ASR Settlement provides for three basic areas of compensation. 

The first is a Base Payment to all ASR Claimants (XL and resurfacing) who have undergone a revision surgery, removing the 
acetabular cup, prior to August 31, 2013. 

The second is for Claimants who have undergone a revision surgery in both their left and right hips (Bilateral Claimants). 

The third addresses patients who have suffered a variety of medical complications following a revision surgery (Extraordinary Injury Fund).

 In addition, the Settlement provides for the resolution of healthcare insurance liens for 
medical costs that are directly associated with the revision surgery, at no additional cost to the 
claimant. 

Click here to read the complete press release issued by the Settlement Oversight Committee

Click here to read about the lawsuit.

….

Jon L. Gelman of Wayne NJ is the author NJ Workers’ Compensation Law (West-Thompson) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson). For over 4 decades the Law Offices of Jon L Gelman  1.973.696.7900  jon@gelmans.com  have been representing injured workers and their families who have suffered occupational accidents and illnesses.

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Saving Academic Medicine from Obsolescence

Today's post was shared by NEJM and comes from blogs.hbr.org

by Benjamin P. Sachs, Ralph Maurer, Steven A. Wartman and Marc J. Kahn  |   10:00 AM November 8, 2013 The United States spent 17.9% of the GDP on healthcare in 2012. Academic medicine, which makes up, approximately, 20% of these costs ($540 billion), is under profound threat. Teaching hospitals and medical schools are faced with declining clinical revenue, dwindling research dollars and increasing tuition costs. To meet these challenges, we believe academic medicine must embrace disruptive innovation in its core missions: educating the next generation of health professionals, offering comprehensive cutting-edge patient care, and leading biomedical and clinical research.  Medical schools and academic health centers will need to significantly adapt in each of these areas in order to ensure the long-term health of the medical profession. The following are a few examples of disruptive innovations Tulane School of Medicine has embraced.         Medical information doubles roughly every five years, making it impossible for physicians to stay current. Computing power has also increased to the point that machines like IBM’s Watson, first programed to play chess and Jeopardy, are now used to diagnose and recommend treatment for patients.  Mary Cummings, one of the first women aviators to land a plane on an aircraft carrier, faced a similar situation when she left the navy; a computer was replacing...

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New ligament discovered in knee, Belgian surgeons say

Today's post is shared from the bbc.com

The anterolateral ligament (ALL) may hold the key to common knee injuries, researchers say Two knee surgeons in Belgium say they have identified a previously unfamiliar ligament in the human knee. Writing in the Journal of Anatomy, they suggest the fibrous band could play a part in one of the most common sports injuries worldwide. Anatomical sketch of ligaments  of the knee By Smitha MundasadHealth  reporter, BBC News Despite glimpses of the ligament in medical history, this is the first time its structure and purpose have been so clearly established, they say. But experts say more studies are needed to prove its relevance to knee surgery. Four main ligaments - or thick fibrous bands - surround the knee joint, criss-crossing between the upper and lower leg bones to provide stability and prevent excessive movement of our limbs. But the anatomy of the knee remains complex, and several international groups have been exploring the less-defined structures of the joint for some time. The notion of this particular ligament was first made by French surgeon Paul Segond in 1879 but it has evaded definitive surgical classification for many years. 'Extensive search' Now building on the work of other surgeons, Dr Claes and Professor Johan Bellemans of the University Hospitals of Leuven, Belgium, say they have closely mapped the band which runs from the outer side of the thigh bone to the shin bone. And they say this anterolateral ligament could play an...

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A Vital Measure: Your Surgeon’s Skill

Today's post is shared from the nytimes.com

To those of us in training, the hospital was cursed. At least when it came to a certain operation. We dreaded being asked to scrub in at these operations because we knew we would be forced to hold patient parts until our fingers went numb and arms quivered. The surgeons hunted, stabbed and slashed their way through the procedure; and whenever their knife would go a little too far, or their knot would slip, or their stitch pull, we braced ourselves for their fury…and for the inevitable extra time it would take for them to correct their errors. The patients, many of whom had come in to the hospital walking and talking, ended up lingering for weeks afterward with infections, open wounds and other complications. But everything changed when a new surgeon came on board. Built like a rugby player, he shocked us first with his speed, and then his results. The once unbearable day-long slog became a morning’s work; and instead of spending weeks in the hospital, his patients went home after eight days. In the operating room, his bear paw hands turned delicate, teasing out tissues, caressing vessels and nimbly knotting thread as fine as human hair. There was not a single wasted movement; and each step blended seamlessly with the next, giving those of us who had the fortune to observe the sense that we were watching not surgery, but a well-choreographed ballet. “It’s like you’re just standing there holding the needle or...

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Spinal fusions serve as case study for debate over when certain surgeries are necessary

The necessity of medical treatment is coming under increased questioning as payers want to rein in costs. This article is shared from the washingtonpost.com. By some measures, Federico C. Vinas was a star surgeon. He performed three or four surgeries on a typical weekday at the Daytona Beach, Fla., hospital that employed him, and a review showed him to be nearly five times as busy as other neurosurgeons. The hospital paid him hundreds of thousands in incentive pay. In all, he earned as much as $1.9 million a year. Yet given his productivity, some hospital auditors wondered: Was all of the surgery really necessary? To answer that question, the hospital in early 2010 paid for an independent review of cases in which Vinas and two other neurosurgeons had performed a common procedure known as a spinal fusion. The review was conducted by board-certified neurosurgeons working for AllMed, a company accredited to audit health-care businesses. Of 10 spinal fusions by Vinas that were selected, nine were deemed not medically necessary, according to a summary of the report. Vinas is still working at Halifax Health, and a hospital spokesman said that, after the AllMed report, the hospital conducted an internal review that validated his surgeries. Another review conducted this year in response to litigation also validated them, the spokesman said. The hospital would not answer further questions or release details of those reviews. Vinas “has never and will never perform an unnecessary surgical procedure on any patient,” his attorney, Robert H. Pritchard, said in a statement. More than 465,000...

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….

Jon L. Gelman of Wayne NJ is the author NJ Workers’ Compensation Law (West-Thompson) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson). For over 4 decades the Law Offices of Jon L Gelman  1.973.696.7900  jon@gelmans.com  have been representing injured workers and their families who have suffered occupational accidents and illnesses.

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US Inspector General Wants More Disclosure By Back Surgeons Who Implant their Own Devices

Back surgery is a big business and the selling of implanted medical devices are costly transactions. The US Office of Inspector General has issued a report today that their should be more disclosure to patients when back surgeons implant their own devices.

"PODs have a substantial presence in the spinal device market. PODs
provided devices used in nearly a fifth of the spinal surgeries billed to
Medicare in FY 2011, and over a third of the hospitals in our sample
purchased spinal devices from PODs. Many of these hospitals began
purchasing from PODs after 2009. Also, few hospitals in our sample
required physicians to disclose their ownership in device companies,
such as PODs, to their patients.

"In FY 2012, hospitals that purchased from PODs performed more spinal
surgeries and had slightly more complex spinal surgery caseloads than
hospitals that did not purchase from PODs. After they began purchasing
from PODs, hospitals experienced increased rates of growth in the
number of spinal surgeries performed as compared to the growth rate for
hospitals overall. Determining the cause for the increased rate of spinal
procedures was beyond the scope of our review.

"In addition, our findings raise questions about PODs’ claims that their
devices cost less than other suppliers. Within the device categories we
examined, PODs’ devices either cost the same as or more than devices
from companies not owned by physicians. This, combined with the
volume of spinal surgeries we found at hospitals that purchase from
PODs, may increase the cost of spinal surgery to the Medicare program
and beneficiaries over time. Further, hospitals inconsistently required
physicians to disclose ownership interests in PODs to either the hospitals
or their patients. Thus the ability of hospitals and patients to identify
potential conflicts of interest among these providers is reduced.

"The Sunshine Act may improve the ability of hospitals and patients to
identify physicians’ investment in device companies. The Act will
require most PODs to report to CMS all physician ownership and
investment interests.18 CMS plans to list these companies and their
payments on a publicly available Web site.

Click here to read the complete report.

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Questioning Statins for Older Patients

Limiting medication can reduce overall patient care costs. The efficacy of controlling cholesterol in the "very old" population is now being discussed. Today's post was shared from the NYTimes.com. Should older adults take statins if they have elevated cholesterol but no evidence of heart disease? It’s a surprisingly controversial question, given the number of seniors taking statins. Recently AMDA, a professional group representing physicians working in nursing homes, highlighted the issue in a list of five questionable medical tests and treatments. The list was drawn up as part of the national “Choosing Wisely” campaign, which alerts consumers to inappropriate or overused medical interventions, an effort that caregivers would do well to follow. The standout item on the AMDA list: “Don’t routinely prescribe lipid-lowering medications in individuals with a limited life expectancy.” That means anyone older than 70, according to the medical society. Dr. Hosam Kamel, an Arkansas geriatrician who is vice chair of AMDA’s clinical practice committee, said that there is scarce scientific evidence supporting the use of statins by 70- or 80-year-olds without pre-existing cardiovascular disease. Only a handful of studies have focused on outcomes (heart attacks, strokes, premature death) in this older population. Most of the data on the benefits of statin use come from larger studies that looked at adults of varying ages. The results...

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The Great Coronary Angioplasty Debate: Giving Patients the Right to Speak | The Health Care Blog

Today's post was shared by The Health Care Blog and comes from thehealthcareblog.com

By Nortin Hadler, MD Earlier this month, the editors of THCB saw fit to post my essay, “The End of the Era of Coronary Angioplasty.” The comments posted on THCB in response to the essay, and those the editors and I have directly received, have been most gratifying. The essay is an exercise in informing medical decisions, which is my creed as a clinician and perspective as a clinical investigator. I use the recent British federal guideline document as my object lesson. This Guideline examines the science that speaks to the efficacy of the last consensus indication for angioplasty, the setting of an acute ST-elevation myocardial infarction (STEMI). Clinical science has rendered all other indications, by consensus, relative at best. But in the case of STEMI, the British guideline panel supports the consensus and concludes that angioplasty should be “offered” in a timely fashion. I will not repeat my original essay here since it is only a click away. The exercise I display is how I would take this last consensus statement into a trusting, empathic patient-physician discourse. This is a hypothetical exercise to the extent that little in the way of clear thinking can be expected of a patient in the throes of a STEMI, and not much more of the patient’s caring community. So all of us, we the people regardless of our credentials, need to consider and value the putative efficacy of angioplasty (with or without stenting) a priori. For me, personally, there is...

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Deaths Linked to Cardiac Stents Rise as Overuse Seen

Cardiovascular claims that are deemed compensable are costly medical and pharmaceutical claims. The procedures are expensive an risky and the pharmaceutical maintenance and monitoring is lifelong and  expensive.Today's post is shared from Bloomberg.com

When Bruce Peterson left the U.S. Postal Service after 24 years delivering mail, he started a travel agency. It was his dream career, his wife Shirlee said. Then he went to see cardiologist Samuel DeMaio for chest pain. DeMaio put 21 coronary stents in Peterson’s chest over eight months, and in one procedure tore a blood vessel and placed five of the metal-mesh tubes in a single artery, the Texas Medical Board staff said in a complaint. Unneeded stents weakened Peterson’s heart and exposed him to complications including clots, blockages “and ultimately his death,” the complaint said. DeMaio paid $10,000 and agreed to two years’ oversight to settle the complaint over Peterson and other patients in 2011. He said his treatment didn’t contribute to Peterson’s death. “We’ve learned a lot since Bruce died,” Shirlee Peterson said. “Too many stents can kill you.” Peterson’s case is part of the expanding impact of U.S. medicine’s binge on cardiac stents -- implants used to prop open the arteries of 7 million Americans in the last decade at a cost of more than $110 billion. When stents are used to restore blood flow in heart attack patients, few dispute they are beneficial. These and other acute cases account for about half of the 700,000 stent procedures in the U.S. annually. Among the other half -- elective-surgery patients in stable...

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EpiPens for All

Today's post was shared by WCBlog and comes from www.nytimes.com

AMARRIA JOHNSON, who attended first grade at Hopkins Elementary School in Richmond, Va., was an outgoing and energetic girl who loved animals, singing and telling jokes. She won reading and citizenship awards and planned to become a teacher. She also was allergic to peanuts. On Jan. 2, 2012, a classmate gave Amarria a peanut on the playground. Despite her allergy, Amarria ate the nut and soon had trouble breathing. She sought out a teacher, but at the school health clinic, there was no epinephrine auto-injector prescribed for Amarria. Epinephrine auto-injectors, the most well known of which are EpiPens, contain adrenaline and are the first line of emergency treatment for anaphylaxis, an extremely severe allergic reaction that can become fatal within minutes. At the time, employees in Amarria’s public school were not allowed to use epinephrine prescribed for one student on a different child; instead, the school called an ambulance, which transported Amarria to a hospital, where she was pronounced dead of anaphylaxis and cardiac arrest. I’m the mother of a child with food allergies, and stories like Amarria’s are my worst nightmare. In describing her tragedy, I question the fairness of reducing a 7-year-old girl to a symbol. Nevertheless I repeat the circumstances of Amarria’s death because it appears they directly affected legislation in her state. Just a few months after she died, “Amarria’s Law” was in place; the law requires...

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Specialty Compounding, LLC Issues Nationwide Voluntary Recall

Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All

Lots of Unexpired Sterile Products Due to Reports of Adverse Events

Specialty Compounding, LLC, a subsidiary of Peoples Pharmacy Inc., is voluntarily recalling all lots of sterile medications within expiry.

The recall was initiated after reports of bacterial infection affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area, whose treatment included IV infusions of calcium gluconate from Specialty Compounding. There is a potential association between the infections and the medication at this time.

If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.

“Because of the potential association between the hospital-based infections and sterile compounded medications produced by Specialty Compounding, we are voluntarily recalling all sterile products out of an abundance of caution,” said Ray Solano, R.Ph., pharmacist in charge at Specialty Compounding. “We deeply regret the impact this recall has on our patients and the hospitals that we serve, but patient safety must always be our first concern.”

Just Go to The Emergency Room

Emergency room medicine is becoming an easy avenue for work-related medical care as employers and insurance carriers keep restricting traditional medical care access. Over the past decades it is becoming increasingly difficult for workers who have suffered occupational accidents or diseases to obtain quick, efficient and authorized diagnostic services and medical treatment.

A recent RAND study now validates that an alternate route is increasingly being used to access the medical care system, the emergency room. Few restrictions exists to enter an emergency room door. The red tape imposed by insurance carriers is eliminated, and the concept of deny and delay are non-existent in emergency room medicine.

Hospital emergency departments play a growing role in the U.S. health care system, accounting for a rising proportion of hospital admissions and serving increasingly as an advanced diagnostic center for primary care physicians, according to a new RAND Corporation study.

While often targeted as the most expensive place to get medical care, emergency rooms remain an important safety net for Americans who cannot get care elsewhere and may play a role in slowing the growth of health care costs, according to the study.

Emergency departments are now responsible for about half of all hospital admissions in the United States, accounting for nearly all of the growth in hospital admissions experienced between 2003 and 2009.

Despite evidence that people with chronic conditions such as asthma and heart failure are visiting emergency departments more frequently, the number of hospital admissions for these conditions has remained flat. Researchers say that suggests that emergency rooms may help to prevent some avoidable hospital admissions.

"Use of hospital emergency departments is growing faster than the use of other parts of the American medical system," said Dr. Art Kellermann, the study's senior author and a senior researcher at RAND, a nonprofit research organization. "While more can be done to reduce the number of unnecessary visits to emergency rooms, our research suggests emergency rooms can play a key role in limiting growth of preventable hospital admissions."

NJ Supreme Court Rules That Only a Physician Can Perform An EMG

Only a licensed physician, and not a physicians assistant, can perform an EMG, ruled the NJ Supreme Court.

Click here to read the complete decision: Selective Insurance Company of American v Arthur C Rothman MD
".... the Legislature intended that only certain licensed physicians, specifically those persons "licensed to practice medicine and surgery pursuant to chapter 9 of Title 45[,]" would be permitted to perform needle EMG tests. As we have explained, physician assistants are not "licensed to practice medicine and surgery" because they do not have the qualifications for such a license."

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Medical Marijuana Maybe Permitted By State Authorization

Image via Wikipedia

Workers' Compensation systems maybe legally  implementing distribution of marijuana for medical purposes on a state by state basis circumventing a Federal prohibition. A Federal Court ruled today that the state authorized distribution program was not subject to Federal restrictions.

Prescription drugs utilization has exploded both in cost factors and in volume leading to major concerns by both employers and insurance carriers. Compounding the issue is that prescription pain relief is being offered more frequently to avoid the both costly and risky surgical intervention and protocols. Additionally there is a concern that state governments merely want to get into the act in order to tax the prescription costs for the purposes of raising revenue.

All of this focuses on the issue of whether the nation's workers' compensation system is actually providing the necessary care to cure and relieve medical conditions as intended by the crafters a century ago.

Click here to read more from the Jurist: Federal judge grants ACLU motion to dismiss Arizona medical marijuana challenge
"A judge for the US District Court for the District of Arizona [official website] on Wednesday granted an American Civil Liberties Union (ACLU) [advocacy website] motion to dismiss a lawsuit [order, PDF] challenging Arizona's voter approved medical marijuana law, the Arizona Medical Marijuana Act [text, PDF]."

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• Contagion in The Workplace: Ready or Not (workers-compensation.blogspot.com)
• Workers Compensation on Drugs - Tenn Supreme Court Allows Fatal Case to Proceed (workers-compensation.blogspot.com)
• Gingrich Calls Present Workers' Compensation System Dangerous (workers-compensation.blogspot.com)
• Rick Santorum Unclear On Medical Marijuana Laws (huffingtonpost.com)

Penalties for Insurance Companies Who Fail to Pay Enough for Medical Care

The quality of medical care for workers' compensation beneficiaries has always been a major issue. Injured workers just don't want to go to an employer selected physician.They want to go to a doctor who provides good quality medical care and one they have confidence in. It makes good medical sense. While one concept to adjust the issue is to compel insurance carriers to pay for outcome driven results. If the doctor cures you, then the doctor should be paid in full for the reasonable value of his or her services. If the opposite, well then maybe the doctor should get paid less.

Another approach, enacted by the federal government is to compel insurance carriers to pay a certain percentage of premiums collected for medical care, instead of paying large sums for administration expenses. That could be applied to workers' compensation carriers. Instead of paying 80% of the premium to fight the claim, workers' compensation insurance companies should be compelled to pay 80% to cure the medical condition.

Read more about this concept:
HHS Unveils Medical Loss Ratio Rule (Kaiser Health Breaking News)

"The Department of Health and Human Services today released its final medical loss ratio rule. According to an HHS press release, the rule will ensure that health insurance companies spend at least 80 percent of consumers' health insurance premiums on medical care rather than on income, overhead and marketing expenses. "If your insurance company doesn't spend enough of your premium dollars on medical care or quality improvement this year, they'll have to give you rebates next year," said CMS Acting Administrator Marilyn Tavenner, in the release . "This will bring costs down and give insurance companies the incentive to focus on what matters for patients – high quality health care."

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For over 3 decades the Law Offices of Jon L. Gelman  1.973.696.7900  jon@gelmans.com have been representing injured workers and their families who have suffered occupational accidents and illnesses.

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The Top 10 Drugs Prescribed For Workers Compensation Claims

A recent study by NCCI Holdings, Inc. reports the top 10 most popular drugs prescribed for workers' compensation claims.

1. OXYCONTIN® 
2. LIDODERM® 
3. HYDROCODONE-ACETAMINOPHEN 
4. LYRICA® 
5. CELEBREX® 
6. GABAPENTIN 
7. SKELAXIN® 
8. CYMBALTA® 
9. MELOXICAM 
10. CYCLOBENZAPRINE HCL 

Workers compensation medical costs per claim average more than $6,000 and soar to nearly $25,000 for lost-time claims. The report examined workers compensation prescription drug (Rx) use, a medical expense that makes up 19% of all workers compensation (WC) medical costs.

Other key findings of the report were:

• The indicated Rx share of total medical is 19%; this is slightly higher than the estimate given in the 2010 update
• OxyContin® climbs from the number 3 WC drug in Service Year 2008 to number 1 in Service Year 2009 
• Hydrocodone-Acetaminophen drops from the top WC drug in Service Year 2008 to number 3 in Service Year 2009 
• Recent overall cost increases are driven more by utilization increases than by price increases 
• Physician dispensing continues to increase in Service Year 2009 in almost every state 
• Increased physician dispensing is associated with increased drug costs per claim 
• Per-claim Rx costs vary significantly by state

For over 3 decades the Law Offices of Jon L. Gelman  1.973.696.7900  jon@gelmans.com have been representing injured workers and their families who have suffered occupational accidents and illnesses.

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