IPG and NEXGEN OsteoBiologics Create Innovative Tissue Management Solution

October 05, 2016

ATLANTA–(BUSINESS WIRE)–IPG, the industry-leading provider of Device Benefit Management solutions, today announced a partnership with NEXGEN OsteoBiologics, a medical biologics marketplace with a national distribution network. The agreement, effective October 1 will help provide cost-efficient biologics to partnering health plans, providers and members.

Currently procedures utilizing osteobiologics materials (sports medicine, spine, dermatology, and breast reconstruction, among others) are on the rise, as are the related costs. These cost increases are partially driven by the increasing complexity of these materials, where lack of transparency often creates highly variable and unjustified pricing across the board.

“NEXGEN is excited to partner with IPG. As the nation’s leading Device Benefit Management firm dedicated to improving quality of care while lowering the overall cost of care, IPG was the ideal partner for NEXGEN,” said Steve Carbonara, Co-Founder of NEXGEN. “Working with healthcare facilities, health plans, and providers, we can remove a tremendous amount of cost in the healthcare supply chain while automating much of the process.”

IPG partners with all of the major national and regional health plans across the country to bring transparency and high quality, cost efficient care to their members. As a participating manufacturer in IPG’s Device Benefit Management program, NEXGEN will serve as a direct vendor to IPG’s partnering providers. The relationship between IPG and NEXGEN will allow IPG to manage all aspects of the device acquisition process including purchasing, billing, provider education, manufacturer account management/negotiation etc. which relieves the cash outlay burden among IPG’s facility customers and streamlines the overall facility process therefore saving money and increasing facility profitability.

“IPG continues to partner with innovative companies like NEXGEN that increase value to clinicians and patients while containing escalating healthcare costs,” said Brian Holt, Chief Innovation Officer for IPG. “Relationships like this allow us to actively participate with our health plan partners to truly deliver value-based healthcare to their members.”

“We are unique in that our solutions help align health plans, providers, facilities, members and manufacturers in the delivery of high quality and cost efficient care. We are proud of the network we’ve built together to deliver on our mission,” said Vince Coppola, President & CEO of IPG.

About NEXGEN OsteoBiologics

NEXGEN is a Tissue Bank Intermediary that distributes a full portfolio of biologic products nationally, from Allograft to Synthetics, acting as a one stop shop to clients and partners while delivering state of the art products from human tissue processors and synthetic manufacturers. Through our proprietary 5 Pillars of Biologic Fingerprinting methodology, NEXGEN is providing transparency and removing ambiguity in the purchasing process. NEXGEN provides ‘spend efficiency consulting services’ for healthcare facilities, health plans and providers, locating areas that can be immediately impacted, reducing costs by 15-30% on total annual spend. This Spend Efficiency Product Analysis System (SEPAS) is provided to any facility for free prior to any contracting to ensure proper alignment and expectations for NEXGEN and their client and partners. For more information about NEXGEN, please visit our website atwww.NEXGENosteobiologics.com or call us at 844-639-4363.

About IPG

As the Device Benefit Management leader, IPG delivers a customized, data-driven approach to enable their health plan partners to manage their surgical and implant costs more effectively. Providing true end-to-end solutions for the healthcare industry, IPG serves as a strategic capability for health plans to manage cost and risk in a unique way that drives collaboration between the plan, their healthcare providers, manufacturers and physicians to ensure that patients receive increased access to affordable and innovative life-saving and life-enhancing device-intensive medical therapies. Additionally, IPG’s award-winning analytics platform for implantable procedures delivers transparency to impact the entire health care transaction process and all sites of care. Continued expansion of IPG’s surgical cost management platform will help health plans to deploy programs that will improve their ability to manage risk and deliver actionable information to everyone involved in a patient’s surgical procedure to drive lower costs and high-quality care for consumers. For more information about IPG, call us at 866.753.0046, or visit us on the web at www.ipg.com.

Contacts

IPG
Kerry Lee Perry, 866-753-0046
kperry@ipg.com
or
NEXGEN OsteoBiologics
Steve Carbonara, 844-639-4363 x102
steve@NEXGENosteobiologics.com

Extremity Reconstruction Market is Expected to Reach $3,041 Million by 2022, Globally – Allied Market Research

PORTLAND, Oregon, October 5, 2016 /PRNewswire

A new report published by Allied Market Research, titled,“Extremity Reconstruction Market by Type and Biomaterial – Global Opportunity Analysis and Industry Forecast 2014- 2022″, states that the global extremity reconstruction market was $1,833 million in 2015 and is expected to reach $3,041 million by 2022, growing at a CAGR of 7.5% from 2016 to 2022. Shoulder reconstruction segment, which accounted for more than 70% in 2015, is expected to dominate the global market throughout the forecast period. North America held the leading position in 2015, and is expected to maintain this trend throughout.

The key drivers of the market include increase in incidence of joint disorders such as osteoarthritis & rheumatoid arthritis coupled with growth in geriatric population and global rise in the prevalence of diabetes & obesity. In addition, increase in awareness among patients about the benefits of small joint reconstruction implants and improvement of technology such as development of stemless shoulder implants, reverse shoulder implants, and ankle reconstruction implants that assist in regaining ankle mobility are expected to propel the market growth. However, unfavorable reimbursement scenario and complications associated with extremity reconstruction surgeries hamper the market growth.

Upper extremity reconstruction implants (such as elbow, radius, hand & wrist, and shoulder) was the leading market segment in 2015, due to increase in the incidences of small joint disorders such as arthritis and fracture. She further added. Ankle replacement segment is expected to grow at a CAGR of 17.4%, owing to technological advancements in this segment. Technological innovations in ankle replacement implants have improved ankle motion in contrast to ankle fusion that restricts movement. Natural biomaterials segment is expected to grow rapidly due to their biocompatible and biodegradable properties.

Key Findings of the extremity reconstruction market Study:

  • The shoulder replacement segment generated the highest revenue in 2015, and is projected to grow at a CAGR of 7.3%.
  • Stemless shoulder implants segment is projected to grow rapidly registering a CAGR of 20.0%.
  • Metallic biomaterial dominated the world extremity reconstruction devices market.
  • Total ankle replacement segment is expected grow at a CAGR of 17.4%.
  • In 2015, the U.S. led in the global extremity reconstruction market, accounting for more than 67% share in the overall market.
  • Germany accounted for about one-third share of the European extremity reconstruction market in 2015.
  • Indian extremity reconstruction devices market is expected to grow at a CAGR of 13.7%.

North America accounted for a major share in 2015, and is expected to maintain this trend throughout the forecast period. This is attributed to rise in prevalence of joint disorders coupled with increase in geriatric population, high awareness regarding the benefits of extremity reconstruction devices, favorable reimbursement rates, presence of innovative technologies, and quest for better quality of life in this region. However, the Asia-Pacific region is expected to grow rapidly owing to the presence of ample growth opportunities in terms of unmet medical needs for the treatment of small joint disorders, increase in awareness about the benefits of extremity reconstruction surgeries, and rise in acceptance of advanced technologies.

Some of the key players profiled in the report include DePuy Synthes (a wholly owned subsidiary of Johnson & Johnson), Stryker Corporation, Zimmer Biomet Holdings, Inc., Smith & Nephew plc., Integra Lifesciences Holdings Corporation, Wright Medical Group N.V., Acumed, Inc., Arthrex, Inc., CONMED Corporation, and Skeletal Dynamics LLC.

 

Summary of Similar Reports can be viewed athttps://www.alliedmarketresearch.com/life-sciences/medical-devices-market-report 

 

About Us: 

Allied Market Research (AMR) is a full-service market research and business-consulting wing of Allied Analytics LLP based in Portland, Oregon. Allied Market Research provides global enterprises as well as medium and small businesses with unmatched quality of “Market Research Reports” and “Business Intelligence Solutions”. AMR has a targeted view to provide business insights and consulting to assist its clients to make strategic business decisions and achieve sustainable growth in their respective market domain.

We are in professional corporate relations with various companies and this helps us in digging out market data that helps us generate accurate research data tables and confirms utmost accuracy in our market forecasting. Each and every data presented in the reports published by us is extracted through primary interviews with top officials from leading companies of domain concerned. Our secondary data procurement methodology includes deep online and offline research and discussion with knowledgeable professionals and analysts in the industry.

 

Contact:
Pankaj Kumar
5933 NE Win Sivers Drive
#205, Portland, OR 97220
United States
Direct: +1-503-894-6022
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Web: https://www.alliedmarketresearch.com

 

© 2016 PR Newswire

US $5 million granted to spinal cord injury robotics research project

5th October 2016

Studies have shown that activity-based interventions can offer a promising approach to the improvement of motor function following spinal cord injury. Sunil Agrawal, professor of mechanical engineering and of rehabilitation and regenerative medicine at Columbia Engineering (New York City, USA) is at the forefront of research efforts to improve recovery through the development of novel robotic devices and interfaces that help patients retrain their movements.

One of Agrawal’s current projects, “Tethered pelvic assist device (TPAD) and epidural stimulation for recovery of standing in spinal cord injured patients,” has recently won a five-year US$5 million grant from the New York State Spinal Cord Injury Board. The project is a collaboration with co-principal investigator, Susan Harkema, and Claudia Angeli in the Department of Neurological Surgery at the University of Louisville, USA, and Joel Stein, chair of the Department of Rehabilitation and Regenerative Medicine, and Ferne Pomerantz , assistant professor of rehabilitation and regenerative medicine in the Department of Rehabilitation and Regenerative Medicine, both at Columbia University Medical Center (New York City, USA). Agrawal’s focus is on improving the effectiveness of stand/balance training during spinal cord injury rehabilitation by using a unique robotic system—Tethered Pelvic Assist Device (TPAD)—invented in his Robotics and Rehabilitation (ROAR) Laboratory at Columbia Engineering.

Agrawal’s TPAD is a wearable, light-weight cable-driven robot that can be programmed to provide both motion perturbations to the pelvis as well as corrective forces to stabilise it. The Agrawal and Harkema groups will combine their expertise and technologies for balance training of SCI patients during standing.

Harkema’s group at the University of Louisville has pioneered the use of activity-based rehabilitation for spinal cord injury patients and, more recently, the use of epidural stimulation of the lumbosacral spinal cord during stand training of spinal cord injury subjects. Their results show the effectiveness of stand training of spinal cord injury patients by combining epidural stimulation and principles of motor learning. The group has successfully shown this strategy to work with the most severely injured individuals.

Even though these patients are able to stand, they are unable to maintain balance. As a result, they have difficulty in transferring this skill to the activities of daily life.

“We are using this technology for the first time to enhance the effectiveness of balance recovery during stand training of spinal cord injury survivors,” says Agrawal, who has, in the past, received funding from the US National Institutes of Health to work extensively on gait training of stroke survivors by designing robotic exoskeletons that can be worn by patients during training in the rehab clinics. “Robotic exoskeletons are typically designed to assist in training of human movements during the swing phase of the gait, but there are currently no robotic devices that can effectively be used for posture and balance training during standing.”

Agrawal’s TPAD consists of a pelvic belt with multiple cables connected to motors, a real-time motion capture system, and a real-time controller to regulate the tensions in the cables. The device is programmed to provide pelvic forces in any direction and respond to motions of the human body. Its tethers can also be configured to apply symmetric or asymmetric forces on the pelvis, as needed by an intervention. The system design allows placement of motors and pulleys on a frame to achieve cable configurations to be able to apply corrective or perturbative forces on the pelvis in any direction, whether these be up, down, or sideways.

“Our TPAD, along with its extensions, can be used in a variety of interventions during walking or standing,” adds Agrawal, who is also a member of Columbia’s Data Science Institute. “So sensory input, repetition, and challenged behaviour can drive the spinal networks to adapt appropriately and generate functional activation across the level of injury. This functional load bearing and acquisition of balance can have a tremendous impact on the continued health and quality of life of individuals with spinal cord injury.”

In addition to the TPAD grant, Agrawal was honored recently by the American Society of Mechanical Engineering with its Machine Design Award for his “seminal contributions to the design of robotic exoskeletons for gait retraining of stroke patients.”

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.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up athttp://ir.conformis.com/.

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.

CONTACT:

Investor contact:

Oksana Bradley

ir@conformis.com

(781) 374-5598

 

Media contacts:

Bill Berry

Berry & Company Public Relations

Bberry@berrypr.com

(212) 253-8881

 

Lynn Granito

Berry & Company Public Relations

Lgranito@berrypr.com

(212) 253-8881

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.

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.

16-1144
Topic:
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.

READ THE REST HERE

Flexion Therapeutics Announces Appointment of John Magee as Vice President of Sales

BURLINGTON, Mass., Sept. 29, 2016 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc.(Nasdaq:FLXN) announced today that it has appointed John Magee as Vice President of Sales, the latest of several key appointments to the company’s leadership team.

Mr. Magee has more than 35 years of experience as a sales professional. Prior to joining Flexion, he was head of U.S. sales for the rare disease unit of Shire Pharmaceuticals, where he also served as U.S. sales director for its renal business. Previously, he held senior sales positions at Esprit Pharma and Bayer Corporation. He has a Bachelor’s degree in biology and anthropology from Hamilton College, and completed MBA courses at the Rochester Institute of Technology.  Mr. Magee joins Flexion as the company prepares to submit a planned new drug application (NDA) in the fourth quarter of 2016 to the U.S. Food and Drug Administration (FDA) for its drug candidate Zilretta™ (also known as FX006), a potential treatment for patients with moderate to severe knee osteoarthritis (OA) pain.

Michael Clayman, MD, President and Chief Executive Officer of Flexion, stated, “John is another excellent addition to the Flexion team as we continue planning for Zilretta’s commercial launch. During his time in the rare disease unit of Shire, he helped to achieve revenue growth of more than $1 billion. John’s experience in successfully recruiting and managing pharmaceutical sales organizations will play a key role for us as we prepare for the potential launch and commercialization of our new investigational treatment in the marketplace in 2017.”

About Flexion Therapeutics

Flexion is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA. The company’s lead product candidate, Zilretta, is being investigated for its potential to provide improved analgesic therapy for the millions of U.S. patients who receive intra-articular (IA) injections for knee OA annually.

Forward-Looking Statements

Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; our plans for, and the expected timing of, our Zilretta NDA submission with the FDA; our plans to commercialize Zilretta[, including the expected timing of commercial launch for Zilretta]; and the potential therapeutic and other benefits of Zilretta, are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with the process of discovering, developing, manufacturing and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics; our reliance on third parties to manufacture and conduct clinical trials of Zilretta, which could delay or limit its future development or regulatory approval; our ability to meet anticipated regulatory filing dates and commercial launch plans for Zilretta; the fact that we will require additional capital, including prior to commercializing Zilretta or any other product candidates, and may be unable to obtain such additional capital in sufficient amounts or on terms acceptable to us; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to Zilretta; competition from alternative therapies; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory approvals to market Zilretta; the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials of Zilretta and may require us to conduct additional clinical trials; Zilretta may not receive regulatory approval or be successfully commercialized, including as a result of the FDA’s or other regulatory authorities’ decisions regarding labeling and other matters that could affect its availability or commercial potential; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

Investor Contact
David Carey
Lazar Partners LTD
T: 212-867-1768 
dcarey@lazarpartners.com

PR Contact
Danielle Lewis
Lazar Partners LTD
T: 212-843-0211
dlewis@lazarpartners.com

Corporate Contact
Fred Driscoll
Chief Financial Officer
Flexion Therapeutics, Inc.
T: 781-305-7763
fdriscoll@flexiontherapeutics.com

Cerapedics Announces Closing of Series D Financing

WESTMINSTER, Colo., Sept. 29, 2016 /PRNewswire/ — Cerapedics, a privately-held orthobiologics company, today announced the company completed an $11 million Series D financing. The funds will be used to expand commercialization of i-FACTOR™ Peptide Enhanced Bone Graft, which was approved by the U.S. Food and Drug Administration (FDA) in November 2015 for use in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease. Additionally, the proceeds will be used to further the development of Cerapedics’ synthetic small peptide (P-15) technology for fusion in the lumbar spine.

“As we close our Series D financing, Cerapedics is well on its way to becoming one of the most innovative and successful private orthobiologics companies in the industry,” said Glen Kashuba, CEO of Cerapedics. “We look forward to accelerating our commercialization efforts in the U.S. following outstanding feedback from surgeons across the country who have been among the first to use i-FACTOR grafts in cervical spine procedures, and are also focused on expanding our presence in international markets in the near future.”

i‐FACTOR bone graft is based on P-15 technology developed by Cerapedics to support bone growth through cell attachment and activation. It is the first bone graft to be approved for use in the cervical spine by the FDA and may be used as a substitute for autologous bone in ACDF procedures. The U.S. surgical market for biologic bone substitutes is estimated to be about $1.5 billion.

About Cerapedics

Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors. More information can be found at www.cerapedics.com.

Media contact:
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com

SOURCE Cerapedics

Related Links

http://www.cerapedics.com

TraumaCad Sales Cement Brainlab Position as UK Market Leader for Orthopedic Surgical Planning

 September 28, 2016

LONDON–(BUSINESS WIRE)–Brainlab, a global leader in medical technology, announced today that it has solidified its position as the dominant force in orthopedic surgical planning, adding 20 new TraumaCad® sites in the United Kingdom in the past 12 months. With consistent annual sales growth in the U.K. of approximately 10 percent, TraumaCad is now available in nearly 70 percent of hospitals in the U.K.

“Before we started using TraumaCad, in January 2016, my colleagues and I were well aware of its excellent reputation amongst our colleagues elsewhere,” said Simon Royston, Sheffield Teaching Hospitals, NHS Trust. “We have found it very intuitive to use and it has been a step-up in the ease and quality of our pre-operative planning. The training and technical support from Brainlab has been superb, all the way from pre-installation to the present.”

Installed at over 2,000 locations worldwide, TraumaCad surgical planning by Brainlab, provides orthopedic surgeons with a comprehensive digital solution for performing pre-operative planning and simulations. The procedure-oriented application includes an extensive digital template library and offers a full set of wizards and measurement tools. Using digital images, surgeons can perform measurements, assess prostheses, simulate osteotomies, and visualize fracture reductions.

“Our explosive growth in TraumaCad sales is not only a great validation of the quality and reputation of our technology, but it is also an important recognition of the growing demand for hospitals and clinics to stay ahead of the curve in orthopedic treatments,” said Ian Wilson, Sales Manager, on behalf of Brainlab. “In most cases, the UK hospitals and clinics that have purchased TraumaCad in the past year or two have replaced other digital templating solutions.”

For more information on TraumaCad, visit www.traumacad.com

About Brainlab

Brainlab, headquartered in Munich develops, manufactures and markets software-driven medical technology, enabling access to advanced, less invasive patient treatments.

Core products center on information-guided surgery, radiosurgery, precision radiation therapy, digital operating room integration, and information and knowledge exchange. Brainlab technology powers treatments in radiosurgery and radiotherapy as well as numerous surgical fields including neurosurgery, orthopedic, ENT, CMF, spine and trauma.

Privately held since its formation in Munich, Germany in 1989, Brainlab has more than 11,000 systems installed in about 100 countries. Brainlab employs 1,350 people in 19 offices worldwide, including 385 Research & Development engineers, who form a crucial part of the product development team.

Contacts

Brainlab
Anna Bliss
T: +49 89 99 156 8172
anna.bliss@brainlab.com