ConforMIS Announces Sale of Over 50,000 Customized Knee Implants

BEDFORD, Mass., Oct. 04, 2016 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that develops, manufactures and sells joint replacement implants that are customized to fit each patient’s unique anatomy, today announced a significant milestone.  ConforMIS has sold more than 50,000 implants, each individually sized and shaped to fit each patient’s unique anatomy.  Unlike manufacturers of traditional “off-the-shelf” knee replacement implants that offer products with a limited range of sizes and geometries, ConforMIS offers a broad line of customized knee implants designed to restore the natural shape of a patient’s knee.  To commemorate this milestone, a group of male and female patients, ages 40-75, will be gathering in Boston to kick-off the ConforMIS Patient Ambassador Program.

“We are thrilled to be commemorating this important company milestone together with our deeply committed team of ConforMIS employees dedicated to delivering innovative, high quality technology.  We are in the business of helping surgeons and healthcare professionals treat their knee replacement patients by offering them a broad line of customized knee implants for individualized orthopedic care.  Understanding that patient-to-patient communication is one of the most meaningful experiences for potential patients seeking joint replacement options, we are excited to introduce a new program designed to facilitate and enable patient connectivity,” said Philipp Lang, MD, MBA, Chief Executive Officer and President of ConforMIS.  “With over 50,000 implants sold, we feel the timing is right to launch this initiative.  Our patients are unique, each and every one of them, and our Patient Ambassador Program will allow the everyday ConforMIS patient to share his or her story with others fighting a similar battle.”

This week ConforMIS is holding its first Patient Ambassador Summit, a special gathering of patients from across the United States treated with ConforMIS customized knee implants in one or both knees. This group includes some of the earliest patients to be treated with a ConforMIS knee implant alongside more recent patients.  The Patient Ambassador group is comprised of patients that have either a partial or total ConforMIS customized knee replacement ranging from the iUni, iTotal CR and iTotal PS, and each will share their personal story.  This week, these patients will have the opportunity to experience firsthand how ConforMIS solutions are individually designed and manufactured using its proprietary software and 3D printing technology.

Each ConforMIS partial and total knee implant, including iTotal® CR, iTotal® PS, iDuo® and iUni®, is developed using proprietary algorithms and computer software to map the articular surfaces of the knee joint, define the areas of disease and convert the imaging data into a three-dimensional model of the knee.  ConforMIS engineers then use computer-aided design, or CAD, software to design the customized implant and single-use, sterile surgical instrumentation that will precisely match the three dimensional model of the patient’s knee.

The focus on innovation in customized implants continues today at ConforMIS.  In March 2016 the company launched iTotal PS, which nearly triples the company’s addressable market.  Like iTotal CR, iTotal PS implants are customized for each patient to avoid compromises on implant fit, rotation and alignment, which can cause residual pain and functional limitations after surgery.

 About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In recent clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 500 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

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Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about the Patient Ambassador Program, the potential clinical, economic or other impacts and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to results seen in ongoing and future clinical and economic studies of our products, risks related to our estimates regarding the potential market opportunity for our current and future products, our expectations regarding our sales and other results of operations, the impact of patient communication programs, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent ConforMIS’s views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS’s views to change. However, while ConforMIS may elect to update these forward-looking statements at some point in the future, ConforMIS specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ConforMIS’s views as of any date subsequent to the date hereof.


Investor contact:

Oksana Bradley

(781) 374-5598


Media contacts:

Bill Berry

Berry & Company Public Relations

(212) 253-8881


Lynn Granito

Berry & Company Public Relations

(212) 253-8881

Eurospine 2016: joimax Launches Its New MultiZYTE SI-Joint Endoscopic Therapy Set And Its New Intracs Interaoperative Navigation Tracking & Control System

IRVINE, Calif., Oct. 4, 2016 /PRNewswire-iReach/ — joimax®, the global acting German developer and marketer of technologies and training methods for endoscopic minimally invasive spinal surgery, will again exhibit at Eurospine 2016 taking place from October 5 – 7 in Berlin. During the conference, joimax®will launch two new products – the MultiZYTE® SI Endoscopic Sacroiliac Joint Therapy Set and its new Intracs® Interaoperative Navigation Tracking & Control System.

MultiZYTE® SI Endoscopic Sacroiliac Joint Therapy is developed for the treatment of the Sacroiliac Joint Syndrome (SIJS), which has been rediscovered as a major back pain generator in recent years. This kind of pain is commonly felt in the lower back, the gluteal region, the hip and thigh and can even radiate into the leg and foot. Until the 1930s, SI-Joint was the main reason for low back pain, but since 1934 the focus has been on disc herniation. According to recent studies, 15 to 25% of all low back pain is caused by the SI-Joint and up to 43% in patients having undergone lumbosacral fusion. MultiZYTE® SI joimax® now offers a well developed and lasting treatment option for this disease.

The Intracs® Interaoperative Navigation Tracking & Control System was developed in cooperation between joimax® GmbH Karlsruhe and fiagon GmbH in Berlin, both located in Germany. With the Intracs® system, joimax® instruments can be navigated directly at the tip using Fiagons “chip at the tip” technology which allows tracking of instruments with a diameter in the 1mm range. The Intracs ® Navigation and Monitor Unit is integrated in the joimax® Endoscopic Tower and all necessary tools are tailored for the TESSYS® (transforaminal) and iLESSYS® (interlaminar) procedures as well as for minimally invasive stabilization procedures, like EndoLIF® and Percusys®. The main features of the Intracs® system are needle navigation through Vector-Tip-Target processing tools, the merging of 2D X-Rays with 3D- images of a patient’s CT or MRI scans, and the constant orientation control of any endoscope used in joimax procedures.

“With these two new developments we are in the position to enhance our endoscopic minimally-invasive product portfolio, driving adoption rates to meet new heights. With the world unique Intracs® system, navigation is now faster, safer and more accurate than ever before using an electromagnetic (EM) field. Radiation exposure for both, patients and surgeons will be significantly reduced,” says Wolfgang Ries, CEO and founder of joimax® “Additionally the learning curve for all spinal endoscopic procedures offered by joimax® will now be significantly reduced and the rapid expansion of all these techniques is now well layed-out,” he continues.

About joimax®

Founded in Karlsruhe, Germany, in 2001, joimax® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS® (transforaminal), iLESSYS® (interlaminar) and CESSYS® (cervical) for decompression procedures, MultiZYTE® RT (e.g. for rhizotomy) and with MultiZYTE® SI for SI-Joint therapy or with EndoLIF®and Percusys® for minimally-invasive endoscopic assisted stabilizations, proven endoscopic systems are provided that, together, cover a whole variety of indications.

In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax® technologies to operate through small incisions – under local or full anesthetic – via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”). For more information visit

Media Contact: Melissa Brumley, joimax® Inc., 001 949 859 3472,

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SOURCE joimax

St. Jude Medical Announces FDA Approval of BurstDR Stimulation, a New Superior Spinal Cord Stimulation Option for Patients Suffering from Chronic Pain

October 04, 2016

ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. approval of BurstDR™ stimulation, a physician-designed form of spinal cord stimulation (SCS) clinically proven to provide superior outcomes for patients with chronic pain over traditional SCS therapy. With FDA approval of BurstDR stimulation, which is exclusive to St. Jude Medical, the company aims to help patients find relief from their pain and suffering while also providing patients a better experience with their chronic pain therapy.

Chronic pain is a complex and challenging condition for physicians to manage, and a heavy burden for patients who find their lives profoundly limited by their pain. Many patients often move from treatment option to treatment option seeking pain relief, only to find a partial or incomplete response to therapy.

Fortunately, SCS therapy can transform quality of life for many people who are otherwise unable to find relief from chronic pain. BurstDR stimulation from St. Jude Medical has been clinically proven to improve upon traditional SCS by generating superior pain relief. With BurstDR stimulation, St. Jude Medical is also helping physicians address their patients’ physical and emotional responses to pain and reduce overall pain and suffering as measured by patients who reported their responses to therapy with BurstDR stimulation through visual analogue scale (VAS) scoring.

“As a physician, reducing the physical sensation of pain experienced by my patients is only part of my job; my ultimate goal is to help patients overcome both the physical pain and the suffering associated with their pain,” said Dr. Timothy R. Deer, president and chief executive officer of The Center for Pain Relief in Charleston, West Virginia. “Now, with BurstDR stimulation, St. Jude Medical has armed physicians with a new therapy option that can reduce patients’ pain and suffering, reduce paresthesia and help us offer our patients a more complete pain management option.”

St. Jude Medical’s proprietary BurstDR stimulation works differently from other stimulation designs, utilizing intermittent “burst” pulses designed to mimic the body’s natural nerve impulse patterns. While other companies have tried to mimic burst patterns, BurstDR stimulation from St. Jude Medical is the only approved form of burst stimulation to have been evaluated in a large scale, multicenter randomized controlled clinical trial.

The St. Jude Medical BurstDR stimulation was introduced after nearly a decade of research and study in collaboration with Prof. Dirk De Ridder, who filed the therapy’s initial patents in 2004. BurstDR stimulation was evaluated within the SUNBURST study, a prospective, randomized multicenter study which confirmed BurstDR stimulation offered superior pain relief over traditional SCS and that the therapy was preferred by most patients over traditional SCS therapy. In addition, BurstDR stimulation from St. Jude Medical has been studied in a large number of international real world studies that have helped the company assess the benefits of the therapy in patients worldwide.

“I am very excited that patients across the United States will now have access to BurstDR stimulation, which has enjoyed strong success across other global markets,” said Prof. De Ridder, from the University of Otago in Dunedin, New Zealand. “When I developed BurstDR stimulation my goal was to introduce an entirely new therapy option, and one that was rooted in the natural way in which the human body responds to and combats the sensation of pain.”

With FDA approval of BurstDR stimulation, patients receiving new implants of the St. Jude Medical Proclaim™ Elite and Prodigy MRI™ spinal cord stimulation systems will have immediate access to the new therapy. Combined, the Proclaim Elite SCS System and BurstDR stimulation offers patients the advantages of the St. Jude Medical Invisible Therapy™ portfolio and an entirely recharge free option, allowing patients to focus on their lives instead of their pain. In addition, patients previously implanted with upgradeable Protégé™ and Proclaim SCS systems will soon be able to upgrade their systems to deliver BurstDR stimulation without additional surgery.

“Chronic pain is one of the most costly epidemic diseases facing health care systems worldwide, and one of the most challenging for physicians to manage due to the complexity of the condition and the differences in each patient’s clinical case,” said Allen W. Burton, M.D., medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “With FDA approval of BurstDR stimulation, we are empowering physicians with a new therapy option in their fight against widespread chronic pain, and our goal is to continue to improve patient outcomes and get more patients the pain relief they deserve.”

About the St. Jude Medical Chronic Pain Portfolio

Chronic pain affects approximately 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. The condition can negatively impact personal relationships, work productivity and a patient’s daily routine. St. Jude Medical is an international leader in the development of chronic pain therapy solutions and the only medical device manufacturer in the world to offer radiofrequency ablation (RFA) and spinal cord stimulation (SCS) therapy solutions including BurstDR stimulation and stimulation of the dorsal root ganglion (DRG) for the treatment of chronic pain.

About St. Jude Medical

St. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit or follow us on Twitter@SJM_Media.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the company, including potential clinical successes, reimbursement strategies, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the company’s control and the risk factors and other cautionary statements described in the company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the company’s Annual Report on Form 10-K for the fiscal year ended January 2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended July 2, 2016. The company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.


St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor Relations
Justin Paquette, 651-756-6293
Public Relations

Stryker’s Spine Division Announces Launch of New LITe® BIO Delivery System

October 04, 2016

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced the launch of its LITe BIO Delivery System, a hand-held device used to facilitate delivery of bone graft material to spinal surgery sites, which simplifies graft delivery, accommodates a surgeon’s preferred graft materials,1 and allows for direct visualization of graft placement.

The unique design of the LITe BIO Delivery System provides surgeons with a single-handed method to deliver any type of autograft, allograft, or synthetic bone graft material without obstructing visibility. The innovative delivery tool provides tactile, visual, and audible confirmation of bone graft delivery, and the mallet-free system eliminates the impaction of bone graft.

According to Bradley Paddock, President of Stryker’s Spine division, the new LITe BIO Delivery System offers significant benefits. Although conventional bone graft delivery methods can accommodate any type of graft material, they can be cumbersome to use. Pre-filled delivery devices are more streamlined but can only be used with specific graft materials.

“Our new LITe BIO Delivery System is innovative in the marketplace, simplifying graft delivery for spine surgeons,” Paddock said. “Its sleek, versatile design can accommodate any bone graft material and provides surgeons with direct visualization to aid in the precise placement of the graft, which is important for optimal fusion. No other system combines all of these key features—the LITe BIO Delivery System truly is advanced delivery, simplified.”

The LITe BIO Delivery System is the latest addition to Stryker’s comprehensive spine portfolio, which includes products and instruments designed for access, interbody, fixation, and fusion. The patented system can be used for any type of spine fusion surgery, including minimally invasive procedures. The low-profile design allows visibility through a decompression tube without obstructing view. A radiolucent strip facilitates visualization under fluoroscopy, and the disposable cannula allows for delivery of up to 5cc of bone graft at one time.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at

1. FDA Cleared Indications for Use: The LITe BIO Delivery System is intended to deliver autograft, allograft or synthetic bone graft materials to all orthopaedic surgical sites.

Content ID BILIT-PR-1_11158


Sullivan & Associates
Barbara Sullivan, 714-374-6174

National Science Foundation Funds Nasseo, Inc. for Nanotube Technology on PEEK Orthopedic Devices

SAN DIEGO, Calif., Oct. 3, 2016 /PRNewswire/ — Nasseo, Inc., a medical technology company dedicated to developing enhanced surface technologies for dental and orthopedic applications, has been awarded a Small Business Innovation Research Grant from the National Science Foundation (NSF).

The NSF grant funding will further Nasseo’s work improving spinal implants by using a nano-engineered surface coating; Nasseo will conduct feasibility studies with an optimized nanotube surface on medical grade polyether ether ketone (PEEK).  When applied to PEEK implants, Nasseo’s nanotube surface technology maintains the benefit of the material’s radiolucency while providing an enhanced bone response. The Company’s aim is to improve the osseointegration of PEEK spinal interbody fusion devices.

“The National Science Foundation’s interest in advancing our work is a distinct honor. The grant will accelerate development of our unique platform surface technology, with an ultimate goal of improving clinical outcomes for orthopedic patient care,” says Nasseo’s Co-founder and CTO Dr. Garrett Cale Smith, who will also serve as primary investigator on the study. Prior to Nasseo, Smith co-founded Oculeve, Inc., a medical technology company acquired by Allergan PLC.

Nasseo holds four issued patents on nanotube platform technology.

To date, over 10 years of research have validated Nasseo’s nanotube surface technology; numerous studies have demonstrated enhanced bone cell response and anti-bacterial properties compared with conventional implant surfaces.

About Nasseo, Inc.
Nasseo, Inc. is a privately owned medical device company developing enhanced surface technologies for dental, spinal, and orthopedic applications. Nasseo was founded based on the intellectual property developed at the University of California, San Diego.  The Company’s TiArray Dental Implant System has received 510(k) clearance. Nasseo is headquartered in San Diego, CA, with research & development facilities in Phoenix, AZ.

SOURCE Nasseo, Inc.

NuVasive Appoints Joan Stafslien as Executive Vice President, General Counsel

SAN DIEGO, CA–(Marketwired – October 03, 2016) – NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced Joan Stafslien is joining the Company as executive vice president, general counsel and corporate secretary. In this role, Ms. Stafslien will oversee the Company’s global legal function, reporting to NuVasive’s chairman and chief executive officer, Gregory T. Lucier, and serving on the company’s executive leadership team.

Ms. Stafslien brings to NuVasive more than 20 years of experience as a legal advisor to medical technology companies. She joins NuVasive from CareFusion, where she served as general counsel and corporate secretary from 2009 until its acquisition by Becton Dickinson in 2015.

“Joan’s experience spans a broad spectrum of legal areas, including intellectual property, U.S. and International litigation, regulatory compliance, SEC matters and M&A, with extensive experience in the global medical technology sector,” said Mr. Lucier. “Joan’s understanding of complex medical technology companies on high growth trajectories makes her a perfect fit with the strong foundation we have established with our legal team. We continue to invest in building a world-class leadership team to support our growing innovation position in the global spine market.”

Ms. Stafslien’s career includes law firm and corporate experience. She previously served as CareFusion’s general counsel, corporate secretary and chief compliance officer where she led the legal team through the spin-off from Cardinal Health in 2009 and the acquisition by Becton Dickinson in 2015. Previously, she was the segment general counsel of Cardinal Health’s Clinical Technologies and Services from 2004 to 2009. Ms. Stafslien joined Cardinal Health through the acquisition of Alaris Medical Systems in 2004, where she served as deputy general counsel and assistant secretary. Prior to joining Alaris, she was in private practice with Brobeck, Phleger & Harrison. Ms. Stafslien serves on the advisory board of the Chemical and Biological Engineering Department of Northwestern University. She holds a law degree from University of Wisconsin Law School and a bachelor’s degree in Chemical Engineering from Northwestern University.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 1,900 person workforce in more than 40 countries around the world. For more information, please visit

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission.NuVasive’s public filings with the Securities and Exchange Commission are available at NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.


  • Investor Contact:
    Suzanne Hatcher
    NuVasive, Inc.
    Email contact

    Media Contact:
    Michael Farrington
    NuVasive, Inc.
    Email contact

How 10 hospitals took their total joint replacement programs to the next level

Written by Laura Dyrda – September 29, 2016

The following 10 hospitals and health systems updated their total joint replacement programs with new initiatives such as data analytics, bundled payments, quality improvement and telehealth.

Here are their stories

Baptist Health System (San Antonio). Global professional services firm Navigant partnered with Baptist Health System in 2012 to develop and implement a program that would fit under the Center for Medicare and Medicaid Innovation’s Bundled Payments for Care Improvement initiative. The updates involved redesigning teams and improving the clinical information sharing strategy for better overall care. The program went live in October 2013 for joint replacements, including new initiatives for physician engagement; post-acute network partnerships; gainsharing and funds flow; and supporting analytics. A 2016 case study showed the hospital saved $2.3 million in the first year after participating in BPCI. The hospital also reported a 10 percent reduction in readmissions, 20 percent reduction in skilled nursing utilization and 22 percent reduction in patient rehab utilization.

Hoag Orthopedic Institute (Irvine, Calif.). Hoag Orthopedic Institute participated in the Cambridge, Mass.-based Institute for Healthcare Improvement’s Joint Replacement Learning Community in 2014 to gather data and identify areas to maximize value. In 2015, the hospital welcomed a chapter of Avant-garde, which provides hospitals with technology and analytics tools to measure clinical and cost data, to improve scalability and to set standards for care. The next step in the hospital’s journey to providing value-based care includes further data analytics for care cycles through the continuum of care. The hospital also was the subject of a Harvard Business School case study examining outcomes, cost reduction and reimbursement. Finally, the hospital has a bundled payment system covering services and participated in the Integrated Healthcare Association’s pilot program in 2010 and the National Orthopedic and Spine Alliance program in 2015.

Hospital for Special Surgery (New York City). The adult reconstruction and joint replacement service at Hospital for Special Surgery provides more than 9,000 hip and knee replacements per year and U.S. News & World Report has ranked the hospital as No. 1 in orthopedics for seven consecutive years. The hospital is using telehealth to engage patients before and after their surgeries to improve outcomes and stay connected to the patients after they return home. HSS and ViiMed developed a standardized framework telehealth program for personalized patient education, information and recorded video activities designed to open lines of communication between patients and providers. Among total knee replacement patients, 97 percent report pain relief and 96.3 percent report return to function two years after surgery.





Preoperative Continuous Peripheral Nerve Blocks in Hip Fracture Patients

By Stuart Grant, MB, ChB, FRCA, Gavin Martin, MB, ChB, FRCA, and Ellen Flanagan, MD  –  Oct 5, 2016

  • Each year, at least 250,000 older people—those 65 years and older—are hospitalized for hip fractures.
  • More than 95% of hip fractures are caused by falling, usually by falling sideways.
  • Women experience three quarters of all hip fractures.
  • Women more often have osteoporosis.
  • Fall prevention programs are

When developing a plan to care for elderly patients with hip fractures, amassing a multidisciplinary team is the first step. With all stakeholders present charting the patient’s journey from arrival to discharge, a discussion of all areas of care and opportunities to reduce unwanted variability and improve care can take place.

As anesthesiologists working on the care improvement team, we had heard discussion about the severe pain many of these patients have to endure from arrival in the emergency room (ER) to continuation in other areas such as the X-ray suite, which we do not normally consider. As acute pain specialists with interests in regional anesthesia, we felt we could offer a better quality patient experience if we placed peripheral nerve catheters in these patients as soon as they arrived in the ER. In a previous review, Riddell et al[1] examined the use of femoral nerve blocks in the ER. Both single-shot and catheter techniques have shown benefit by reducing pain scores and opioid consumption. Additionally, reductions in respiratory and cardiac side effects have been noted without any increase in any adverse events.

In collaboration with ER colleagues, we developed a plan to call anesthesiology as soon as a hip fracture was diagnosed. We used an electronic order set, which is triggered by the ER provider when the orthopedic surgeon is called.

The thought of taking on another off-service burden was something that was met with some resistance by a minority of colleagues. We all consider ourselves to be busy all the time, but when we analyzed the total number of patients with hip fractures who are admitted each year, we realized that this was not going to be an overwhelming burden for any individual provider and that it would be a huge benefit to individual patients. The calls would be taken by all providers who covered in-house calls within our institution. Colleagues not on the acute pain service expressed reservations about their ability to actually perform the blocks. To address this issue, we created an education program which was delivered repeatedly to colleagues through didactics and online education. Support was offered to ensure that everyone who might be called to provide this service could comfortably meet the expectations. One of the ways this was done was to provide direct clinical support during weekday calls for these catheters. An acute pain faculty member would accompany a generalist when he or she was placing femoral nerve catheters. In this way, the faculty member could answer questions and provide technical support for this procedure to improve the comfort level and expertise of all anesthesiologists in the department.

In addition, each day our anesthesia technicians ensured that all the equipment necessary was loaded into a bag stored beside the ultrasound machine. The bag contained our peripheral nerve catheter kits, ultrasound gel, consent form (for the nerve block and the surgery the next day), and a check list of all required equipment. Drugs cannot be stocked in the bag per regulations of the Centers for Medicare and Medicaid Services (CMS) and still have to be added from pharmacy before departure for the ER. The stocked bag and checklist minimized inconvenience to the patient as well as off-service providers who have to travel off-site and do not realize what equipment is missing until they arrive in the ER.



Hospital Chain Will Pay over $513 Million for Defrauding the United States and Making Illegal Payments in Exchange for Patient Referrals; Two Subsidiaries Agree to Plead Guilty

Monday, October 3, 2016 – Dept of Justice

Hospital Chain Will Pay over $513 Million for Defrauding the United States and Making Illegal Payments in Exchange for Patient Referrals; Two Subsidiaries Agree to Plead Guilty

A major U.S. hospital chain, Tenet Healthcare Corporation, and two of its Atlanta-area subsidiaries will pay over $513 million to resolve criminal charges and civil claims relating to a scheme to defraud the United States and to pay kickbacks in exchange for patient referrals.

Principal Deputy Assistant Attorney General David Bitkower of the Justice Department’s Criminal Division; U.S. Attorney John Horn of the Northern District of Georgia; Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division; U.S. Attorney G.F. Peterman III of the Middle District of Georgia; Georgia Attorney General Samuel S. Olens; Acting Special Agent in Charge George Crouch of the FBI’s Atlanta Field Office; and Special Agent in Charge Derrick L. Jackson of the U.S. Department of Health and Human Services-Office of Inspector General (HHS-OIG) in Atlanta made the announcement.

In addition, two Tenet subsidiaries, Atlanta Medical Center Inc. and North Fulton Medical Center Inc., have agreed to plead guilty to conspiracy to defraud the United States and to pay health care kickbacks and bribes in violation of the Anti-Kickback Statute (AKS).  The plea agreements remain subject to acceptance by the court.  Up until April 2016, Atlanta Medical Center Inc. and North Fulton Medical Center Inc. owned and operated acute-care hospitals located in the greater Atlanta metropolitan area.

Atlanta Medical Center Inc. and North Fulton Medical Center Inc. were charged in a criminal information filed today in federal court in Atlanta with conspiracy to defraud the United States by obstructing the lawful government functions of HHS and to violate the AKS, which, among other things, prohibits payments to induce the referral of patients for services paid for by federal health care programs.  The two Tenet subsidiaries have agreed to plead guilty to the charges alleged in the criminal information and will forfeit over $145 million to the United States – which represents the amount paid to Atlanta Medical Center Inc. and North Fulton Medical Center Inc. by the Medicare and Georgia Medicaid programs for services provided to patients referred as part of the scheme.

Tenet HealthSystem Medical Inc. and its subsidiaries (collectively THSM) entered into a non-prosecution agreement (NPA) with the Criminal Division’s Fraud Section and the U.S. Attorney’s Office of the Northern District of Georgia related to the charges in the criminal information.  THSM is the parent company of Atlanta Medical Center Inc., North Fulton Medical Center Inc., Spalding Regional Medical Center Inc. and Hilton Head Hospital, and employed their executives.  THSM is a subsidiary of Tenet Healthcare Corporation.  Under the terms of the NPA, THSM and Tenet will avoid prosecution if they, among other requirements, cooperate with the government’s ongoing investigation and enhance their compliance and ethics program and internal controls.  Tenet has also agreed to retain an independent compliance monitor to address and reduce the risk of any recurrence of violations of the AKS by any entity owned in whole, or in part, by Tenet.  The term of THSM’s and Tenet’s obligations under the NPA is three years, but the NPA may be extended for up to one year.

In the civil settlement, Tenet agreed to pay $368 million to the federal government, the state of Georgia and the state of South Carolina to resolve claims asserted in United States ex rel. Williams v. Health Mgmt. Assocs., Tenet Healthcare, et al., a lawsuit filed by Ralph D. Williams, a Georgia resident, in the Middle District of Georgia, under the federal and Georgia False Claims Acts.  The acts permit whistleblowers to file suit for false claims against the government entities and to share in any recovery.  The federal share of the civil settlement is $244,227,535.30, the state of Georgia will recover $122,880,339.70 and the state of South Carolina will recover $892,125.  Mr. Williams’ share of the combined civil settlement amount is approximately $84.43 million.

“When pregnant women seek medical advice, they deserve to receive care untainted by bribes and illegal kickbacks,” said Principal Deputy Assistant Attorney General Bitkower.  “The Tenet case is the first brought through the assistance of the Criminal Division’s corporate health care fraud strike force.  This is one of more than a dozen active corporate investigations by the strike force, and we are committed to following evidence of health care fraud wherever it leads – whether it be individual physicians, pharmacy owners or corporate boardrooms.”

“Our Medicaid system is premised on a patient’s ability to make an informed choice about where to seek care without undue interference from those seeking to make a profit,” said U.S. Attorney Horn.  “Tenet cheated the Medicaid system by paying bribes and kickbacks to a pre-natal clinic to unlawfully refer over 20,000 Medicaid patients to the hospitals.  In so doing, they exploited some of the most vulnerable members of our community and took advantage of a payment system designed to ensure that underprivileged patients have choices in receiving care.”

“The Department of Justice continues to devote enormous resources to exposing and pursuing alleged misconduct of improper financial relationships between hospitals and referral sources,” said Principal Deputy Assistant Attorney General Mizer.  “Such relationships exploit vulnerable populations and threaten to drive up the cost of healthcare for everyone.  In addition to yielding a substantial recovery for taxpayers, this settlement reflects the department’s lack of tolerance for these types of abusive arrangements, and the negative effects they can have on our health care system.”

“The global resolution of this complex and sophisticated fraud scheme exemplifies what can be accomplished through the cooperation of federal and state investigative and prosecutorial authorities,” said U.S. Attorney Peterman.  “I am particularly proud of the civil attorneys in the U.S. Attorney’s Office for the Middle District of Georgia, working hand in hand with investigators of the U.S. Department of Health and Human Services and attorneys in the Civil Division and the Medicaid Fraud Control Unit of the Office of the Attorney General of Georgia, whose combined efforts greatly contributed to this outstanding result on behalf of the American taxpayers.”

“Tenet took advantage of vulnerable pregnant women in clear violation of the law by paying kickbacks in order to bring their referrals to Tenet hospitals,” said Georgia Attorney General Olens.  “Through this scheme, Tenet defrauded the Georgia Medicaid program, and reaped hundreds of millions of dollars.  This is an unprecedented settlement for the state of Georgia, and reflects my office’s commitment to protecting Georgia taxpayers by uncovering Medicaid fraud and abuse.”

“The FBI continues to play a significant role in ensuring that federal laws related to the healthcare industry, to include the federally funded Medicare and Medicaid programs, are enforced,” said Acting Special Agent in Charge Crouch.  “The settlement agreements announced today involving Tenet Healthcare Corporation, as well as related guilty pleas by two of its Atlanta-based hospitals, Atlanta Medical Center Inc., and North Fulton Medical Center Inc., are a clear example of those efforts.  In addition, the FBI’s Major Provider Response Team (MPRT) assisted the Atlanta Field Office in the civil and criminal investigation of Tenet.  The MPRT was created in 2011 in response to numerous healthcare related corporate-level schemes resulting in billions in losses to healthcare plans.  The FBI, along with its MPRT, will continue to aggressively address the threat of large-scale corporate healthcare schemes significantly impacting both private and government healthcare benefit plans.”

“OIG continues to emphasize investigation of improper financial relationships between health care providers,” said Special Agent in Charge Jackson.  “Using their positions of trust, health providers – after receiving payments from Tenet – sent expectant women specifically to Tenet hospitals.  Patients were often directed to Tenet facilities miles and miles from their homes and on their journeys passed other hospitals that could have provided needed care.  These women were thereby placed at increased risk during one of the most vulnerable points in their lives.  HHS-OIG will continue to protect patients by exposing such illegal arrangements.”

As alleged in the criminal information as well as civil complaints filed by the department and the state of Georgia in 2014 and 2013, Atlanta Medical Center Inc., North Fulton Medical Center Inc., Spalding Regional Medical Center Inc. and Hilton Head Hospital paid bribes and kickbacks to the owners and operators of prenatal care clinics serving primarily undocumented Hispanic women in return for the referral of those patients for labor and delivery medical services at Tenet hospitals.  These kickbacks and bribes allegedly helped Tenet obtain more than $145 million in Medicaid and Medicare funds based on the resulting patient referrals.

According to the criminal information, as part of the scheme, expectant mothers were in some cases told at the prenatal care clinics that Medicaid would cover the costs associated with their childbirth and the care of their newborn only if they delivered at one of the Tenet hospitals, and in other cases were simply told that they were required to deliver at one of the Tenet hospitals, leaving them with the false belief that they could not select the hospital of their choice.  The criminal information alleges that as a result of these false and misleading statements and representations, many expectant mothers traveled long distances from their homes to deliver at the Tenet hospitals, placing their health and safety, and that of their newborn babies, at risk.

The criminal information also charges Atlanta Medical Center Inc. and North Fulton Medical Center Inc. with conspiring to defraud HHS in its administration and oversight of the Medicare and Medicaid Programs, including HHS-OIG’s enforcement of Tenet’s September 2006 corporate integrity agreement (the CIA).  The criminal information and the civil complaint allege that many of the unlawful payments happened while Tenet was under the CIA.  The criminal information further alleges that certain executives of Atlanta Medical Center Inc., North Fulton Medical Center Inc. and others concealed these unlawful payments from HHS-OIG during the pendency of the CIA by, among other things, falsely certifying compliance with the requirements of the CIA and failing to disclose reportable events relating to the unlawful relationship under the CIA.

* * *

Deputy Chief Joseph S. Beemsterboer, Assistant Chief Robert A. Zink and Trial Attorneys Sally B. Molloy, Antonio M. Pozos and A. Brendan Stewart of the Criminal Division’s Fraud Section and Chief Randy S. Chartash and Deputy Chief Stephen McClain of the Northern District of Georgia’s Economic Crime Section represented the government in the criminal prosecution.  The U.S. Attorney’s Office of the Middle District of Georgia and the Civil Division’s Commercial Litigation Branch represented the federal government in the civil case.  The HHS Office of Counsel to the Inspector General, the FBI and the Georgia and South Carolina Medicaid Fraud Control Units provided assistance in this matter.

The FBI’s Atlanta Field Office, HHS-OIG and the FBI Healthcare Fraud Unit MPRT investigated the case.

This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by the Attorney General and the Secretary of HHS.  The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.  One of the most powerful tools in this effort is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $30.9 billion through False Claims Act cases, with more than $18.6 billion of that amount recovered in cases involving fraud against federal health care programs.

If you believe you are a victim of this offense, please visit this website or call (888) 549-3945.

Healthcare Fraud
Updated Octo

Minnesota Hiking Obamacare Premiums At Least 50% To Avoid ‘Collapse’

10/01/2016 – By Blake Neff

Minnesota will let health insurers increase their rates by at least 50 percent next year to protect the state’s Obamacare health insurance individual market from “collapse,” the state announced Friday.

The announcement came from Minnesota commerce commissioner Mike Rothman, who explained bluntly that the state’s individual market was barely staying afloat.

“The Commerce Department pursued every option within its power to avert a collapse this year,” said Rothman. “We succeeded in saving the market for 2017, with only Blue Cross leaving. But the rates insurers are charging will increase significantly to address their expected costs and the loss of federal reinsurance support.”

The increase in premiums for next year will range between 50 percent and a staggering 67 percent. This comes on the heels of an increase of between 14 percent and 49 percent for 2016. After those increases, Rothman warns, the annual growth rate will be completely unsustainable, showing a desperate need for reform.