medical

Former Medical Doctor Sentenced to 20 Years in Prison for Engaging in Illicit Sexual Conduct with Minors in Kenya

A former medical doctor was sentenced today to serve 20 years in prison for engaging in illicit sexual conduct with minors in Kenya.



  • OPA Press Releases

medical

Tennessee Cardiologist to Pay $1.15 Million to Settle Allegations That He Performed Medically Unnecessary Heart Procedures

Cardiologist Dr. Elie H. Korban will pay $1.15 million to resolve False Claims Act allegations that he billed Medicare and Medicaid for medically unnecessary cardiac stent placement.



  • OPA Press Releases

medical

Medical Clinic Owner Pleads Guilty in Miami for Role in Multiple Health Care Fraud Schemes Totaling Over $20 Million

The owner and operator of a Miami medical clinic pleaded guilty today in connection with multiple health care fraud schemes involving the defunct clinic Merfi Corp.



  • OPA Press Releases

medical

Medical Clinic Owner and Other Patient Recruiters Plead Guilty in Miami for Roles in $8 Million Health Care Fraud Scheme

Several patient recruiters, including a medical clinic owner, pleaded guilty today in connection with a health care fraud scheme involving Flores Home Health Care Inc., a defunct home health care company.



  • OPA Press Releases

medical

Medical Device Manufacturer Charged With Major Securities Fraud Scheme

ArthroCare Corporation, a medical device manufacturer based in Austin, Texas, and that trades on the NASDAQ stock exchange, has agreed to pay a $30 million monetary penalty to resolve charges that senior executives at the company engaged in a securities fraud scheme that resulted in more than $400 million in shareholder losses.



  • OPA Press Releases

medical

Alabama Medical Clerk and Another Indicted in Stolen Identity Tax Refund Fraud Schemes

Sasha Webb and Charlie Jackson have each been indicted for stolen identity refund fraud crimes, Assistant Attorney General Kathryn Keneally of the Justice Department's Tax Division and U.S. Attorney George L. Beck Jr. for the Middle District of Alabama announced today.



  • OPA Press Releases

medical

Owner of Houston Medical Equipment Companies Indicted for $3.4 Million Medicare Fraud Scheme

Huey P. Williams Jr., the owner and operator of two durable medical equipment (DME) companies, was arrested yesterday for his alleged role in a $3.4 million Medicare fraud scheme.



  • OPA Press Releases

medical

Durable Medical Equipment Clinic Owner Sentenced for His Role in $11 Million Health Care Fraud Scheme

The former owner of a defunct durable medical equipment (DME) clinic was sentenced today in Miami to serve 70 months in prison for his role in an $11 million health care fraud scheme involving World Class Medical Clinic Corp.



  • OPA Press Releases

medical

Washington-Based Medical Device Manufacturer to Pay up to $5.25 Million to Settle Allegations of Causing False Billing of Federal Health Care Programs

Medical device manufacturer EndoGastric Solutions Inc. has agreed to pay the government up to $5.25 million to resolve allegations that it violated the False Claims Act by misleading health care providers about how to bill federal health care programs for a procedure using a device manufactured by the company and by paying kickbacks.



  • OPA Press Releases

medical

Medical Clinic Owner and Other Patient Recruiters Sentenced for Roles in $8 Million Health Care Fraud Scheme

Several patient recruiters, including a medical clinic owner, were sentenced today for their participation in a health care fraud scheme involving Flores Home Health Care Inc., a defunct home health care company.



  • OPA Press Releases

medical

Medical Clinic Owner Sentenced for Role in Multiple Health Care Fraud Schemes Totaling Over $20 Million

The owner and operator of a Miami medical clinic, Merfi Corp., was sentenced today to serve 108 months in prison for her participation in multiple health care fraud schemes.



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medical

Government Intervenes in Lawsuit Against Medical Equipment Supplier Orbit Medical Inc. and Former Vice President Jake Kilgore

The government has intervened in a False Claims Act lawsuit against Orbit Medical Inc. and Jake Kilgore alleging that Orbit Medical’s sales representatives boosted power wheelchair and accessory sales by altering and forging physician prescriptions and supporting documentation.



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medical

King’s Daughters Medical Center to Pay Nearly $41 Million to Resolve Allegations of False Billing for Unnecessary Cardiac Procedures and Kickbacks

Ashland Hospital Corp. d/b/a King’s Daughters Medical Center (KDMC) has agreed to pay $40.9 million to resolve allegations that it submitted false claims to the Medicare and Kentucky Medicaid programs for medically unnecessary coronary stents and diagnostic catheterizations.



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medical

Medical Device Inventor Sentenced to Prison for Tax Fraud

Ashvin Desai, of San Jose, California, was sentenced yesterday to serve six months in prison and six months and one day of home confinement for concealing more than $8 million in foreign bank accounts, the Justice Department and Internal Revenue Service (IRS) announced. Prior to yesterday’s sentencing hearing, Desai filed with the court a document indicating that the IRS has assessed and demanded payment of a Reports of Foreign Bank and Financial Accounts (FBAR) penalty against him for $14,229,744



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medical

Government Files Suit Against Missouri Neurosurgeon and Medical Device Supplier for Violations of the False Claims Act and Anti-Kickback Statute

The Justice Department announced today that it has filed a complaint against Midwest Neurosurgeons L.L.C. and its owner, Dr. Sanjay Fonn, M.D., and DS Medical L.L.C. and its owner, Deborah Seeger, for allegedly violating the Medicare Anti-Kickback Statute and the False Claims Act by conspiring to solicit and receive commissions from medical device manufacturers related to the purchase of spinal implants and supplies used during spinal fusion surgeries performed by Dr. Fonn



  • OPA Press Releases

medical

Vascular Solutions Inc. to Pay $520,000 to Resolve False Claims Allegations Relating to Medical Device

Vascular Solutions Inc. (VSI) has agreed to pay $520,000 to resolve allegations that it caused false claims to be submitted to federal health programs by marketing a medical device for the ablation (or sealing) of perforator veins without FDA approval and despite the failure of its own clinical trial, the Justice Department announced today



  • OPA Press Releases

medical

Former Owner of Southern California Medical Supply Company Found Guilty for a 10-Year, $8.3 Million Medicare Fraud Scheme

On July 31, 2014, a federal jury in Los Angeles found that the former owner of a durable medical equipment (DME) supply company located in Carson, California, was guilty of health care fraud charges relating a 10-year scheme in which Medicare was fraudulently billed more than $8 million for DME that was not medically necessary



  • OPA Press Releases

medical

Co-Owner of Atlanta-Based Medical Clinic Chain and Hospital CEO Pleaded Guilty to Illegal Pay-for-Patient Conspiracy

A CEO of an Atlanta-area hospital and the co-owner and chief operating officer of an Atlanta-based medical clinic chain pleaded guilty in connection with the payment of illegal kickbacks to clinics in exchange for Medicaid patient referrals to hospitals in the Atlanta area and on Hilton Head Island, South Carolina



  • OPA Press Releases

medical

Former Owner of Los Angeles Medical Clinic Management Company Pleads Guilty in $3.2 Million Medicare Fraud Scheme

The former owner of a Los Angeles medical clinic management company pleaded guilty today in connection with his role in a scheme to defraud Medicare



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medical

United States Pursues Claims Against Neurosurgeon, Spinal Implant Company, Physician-Owned Distributorships and Their Non-Physician Owners for Alleged Kickbacks and Medically Unnecessary Surgeries

The United States has filed two complaints under the False Claims Act against Michigan neurosurgeon Dr. Aria Sabit, spinal implant company Reliance Medical Systems, two Reliance distributorships—Apex Medical Technologies and Kronos Spinal Technologies—and the companies’ owners, Brett Berry, John Hoffman and Adam Pike.



  • OPA Press Releases

medical

Detroit-Area Doctor Admits to Providing Medically Unnecessary Chemotherapy to Patients

A Detroit-area hematologist-oncologist pleaded guilty today for his role in a health care fraud scheme, admitting that he administered unnecessary chemotherapy to fraudulently bill the Medicare program and private insurance companies. According to court records, the scheme enabled the doctor to submit approximately $225 million in claims to Medicare over six years.



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medical

New FDA guidance on alternate approaches in premarket notification for Class II medical devices

By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket …

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medical

The Health Care Practitioner Channel: Connecting Industry and Medical Professionals

Selling directly to health care practitioners, supplement companies can foster open dialogue about their products; but, every regulation applies to products in this channel, too.




medical

Promoting Trade in Medical Goods Will Save Lives

Medical supplies and personal protective products are facing barriers worldwide




medical

RE: Guidance for off-label use of medical devices in Canada (Health Canada)?

From : Communities>>Regulatory Open Forum
Thank you Dinar! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------




medical

RE: Guidance for off-label use of medical devices in Canada (Health Canada)?

From : Communities>>Regulatory Open Forum
Thank you Richard! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------




medical

RE: Medical Device Submissions - Worldwide

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Have you looked into PRA Health Sciences?




medical

PLM v. Re-seller for CE Mark of Medical Device System

From : Communities>>Regulatory Open Forum
Hi All, Always appreciate and respect the great advice that comes through this forum: The scope of my question is CE Mark of a Class IIa medical device system under the MDD (and then eventually MDR): We have Class I devices which will be CE Marked through self-certification. These devices can be used with other CE marked products (not owned by us). One of which is not CE Marked as a medical device (conformity to machinery and low voltage directives). In terms of what we consider this vendor, what [More]




medical

Philly-based gene therapy firm teams up with UMass Medical researcher

Guangping Gao, the head of the Horae Gene Therapy Center at the University of Massachusetts Medical School, will partner with Philadelphia-based Spark Therapeutics to figure out better ways to get disease-curing genes into cells. The collaboration, announced this morning, gives Spark (Nasdaq: ONCE) the option for an exclusive, world-wide license for any intellectual property to come out of it. No financial terms were disclosed. Earlier this year, Gao was featured in Newsweek magazine for seemingly…




medical

Principles for COVID-19 Healthcare Communications – 2 – The Virtual Medical Meeting

Virtually everyone is going virtual. Even in February, which seems like a very long time ago, many organizers began either postponing or canceling major conferences and meetings. This has included major medical meetings and given that large gatherings will be … Continue reading




medical

Case Study: When does “technology” turn into medical device

This semester I’ve embarked on an adventure to co-teach a class in the University of Wisconsin-Madison Masters in Biotechnology program. What sold me on the experience was the majority of my responsibility is interacting with second year students on their final major project (essentially their thesis). That said, I will give one lecture, which will be “health

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medical

New EU Rules for Medical Devices

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies the applicable rules when importing medical devices into Europe, which is the world’s second-largest device market. Rules relate, for...… Continue Reading




medical

New MDCG guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions

When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […]




medical

High-level Postdoctoral research fellow recruitment - The international Joint Center for Biomedical Innovation (JCBI), Henan University : Kaifeng, China

The international Joint Center for Biomedical Innovation (JCBI) is comprised of two partner research nodes using nanoparticle technologies to develop solutions for cancer and neurodegenerative diseases diagnostics. Henan University has established a new research laboratory in nano-bio system innovation and theranostics, with start-up funding and new academic positions. Macquarie’s node is built upon its established excellence in neuroscience and cancer research programs. The collaborative succes…




medical

Talents Recruitment by Shandong First Medical University (Shandong Academy of Medical Sciences)

Shandong First Medical University (Shandong Academy of Medical Sciences) has been actively promoting the strategy of “invigorating the university through talents” and therefore has formulated a series of high-level talent introduction programs, and welcome talents at home and abroad to join us.

1. Qualifications for Different Levels of Applicants:

(1) Strategic Talents

This level targets academicians or experts with the qualifications that the applicants should be no more than 65 …




medical

Biomedical ethics 2.0: redefining the meaning of disease, patient and treatment




medical

Schumacher medical files stolen

Medical records purported to be those of Michael Schumacher have been stolen and offered for sale, according to his management




medical

Schumacher medical files suspect found hanged

A man suspected to be involved in the case surrounding Michael Schumacher's stolen medical records has been found hanged in his prison cell, according to Zurich prosecutors




medical

Affordable Care Encourages Healthy Living: Theory and Evidence from China’s New Cooperative Medical Scheme

On May 25th, 2016, the Brookings-Tsinghua Center and China Institute for Rural Studies hosted a public lecture on the topic –Affordable Care Encourages Healthy Living: Theory and Evidence from China's New Cooperative Medical Scheme, featuring Dr. Yu Ning, assistant professor of Economics at Emory University.

      
 
 




medical

Are medical care prices still declining?

More than two decades ago a well-known study provided evidence from heart attack treatments suggesting that prices in medical care were actually declining, when appropriately adjusted for quality. The topic has only grown in importance in the past two decades, as the share of the gross domestic product (GDP) devoted to medical care rose substantially.…

       




medical

State of biomedical innovation conference


Event Information

March 13, 2015
9:00 AM - 11:30 AM EDT

Falk Auditorium
Brookings Institution
1775 Massachusetts Avenue NW
Washington, DC 20036

Register for the Event

As policy agendas for 2015 come into sharper focus, much of the national conversation is aimed at tackling challenges in biomedical innovation. The first two months of the year alone have seen landmark proposals from Congress and the Obama Administration, including the House’s 21st Century Cures initiative, a bipartisan Senate working group focused on medical progress, President Obama’s Precision Medicine Initiative and a number of additional priorities being advanced by federal agencies and other stakeholders.

On March 13, the Engelberg Center for Health Care Reform hosted the State of Biomedical Innovation Conference to provide an overview of emerging policy efforts and priorities related to improving the biomedical innovation process. Senior leaders from government, academia, industry, and patient advocacy shared their thoughts on the challenges facing medical product development and promising approaches to overcome them. The discussion also examined the data and analyses that provide the basis for new policies and track their ultimate success.

 Join the conversation by following @BrookingsMed or #biomed

Video

Audio

Transcript

Event Materials

      




medical

The medical device tax: A primer


Quickly following on the heels of the midterm elections, Senate Majority Leader Mitch McConnell (R-KY) indicated that the medical device tax was a key target for repeal in the 114th Congress. Today, the Senate Finance Health Care Subcommittee will hold a hearing about the effects of the 2.3 percent tax that was included in the Affordable Care Act. Many believe that a repeal is, in fact, possible. Below is a basic primer about the tax and its contentious history.

1. What is the medical device tax?

Included in the Affordable Care Act (ACA) and launched in 2013, the medical device tax imposes a 2.3 percent sales tax on medical device supplies. The tax applies broadly to a range of products, including pacemakers, artificial joints, surgical gloves, and dental instruments. It does not apply to eyeglasses, contact lenses, hearing aids, wheelchairs, or any other device that the public generally buys for individual use. Further, the tax is applied equally to imported and domestically produced devices, and devices produced in the U.S. for export are tax-exempt.

2. Why was it included in the Affordable Care Act?

According to the Joint Committee on Taxation, the tax is estimated to bring in $29 billion over the next decade. The tax was one of many revenue-raising provisions designed to offset the cost of providing coverage to more than 25 million Americans through the ACA, and these newly insured individuals would likewise increase demand for medical device manufacturers' products and services. Other industries were subject to levies as well, including health plans (an estimated $101 billion), and employers (an estimated $130 billion). It has been noted that then-Senator John Kerry from Massachusetts helped negotiate the tax from 4.6 percent to 2.3 percent.

3. How has the medical device industry responded?

The U.S. is home to more than 7,000 medical device companies with estimated annual sales of $106 to $116 billion per year. The largest concentrations of companies are located in California, Massachusetts, New York and Minnesota. Since 2010, the medical device industry has led a full court press effort to repeal the tax. Companies and trade groups argue that the tax would cost over 40,000 U.S. jobs, and undermine innovation by moving manufacturing offshore - conclusions that are heavily contested by the tax's supporters.

By some accounts this tax is coming at a particularly challenging time for medical device innovation. A recent analysis by Ernst & Young reported that venture capital investment in medical devices in 2013 fell 17% from the previous year, a downward trend that has been observed for the past seven years. In addition, investment funding is also shifting towards less risky later-stage medical device companies instead of smaller earlier stage ventures. These trends are worrisome since early-stage investment companies can promote innovative and disruptive medical device technologies that introduce new therapeutic benefits or quantum improvements in patient care.

It is unclear what impact the medical device tax will have on investment in early stage innovation. Key factors that have reduced the availability of venture capital for early-stage medical device companies pursuing pre-market approval include U.S. regulatory unpredictability and delays in approval, and an uncertain reimbursement environment. Additionally, efforts outside the U.S to attract medical device investment, such as offering tax havens and other incentives for device developers in Ireland and the Netherlands add to the attractiveness for device companies to move out of the U.S. Moving to a country that has lower tax rates and less stringent corporate governance requirements may save large device companies billions of dollars.

Recognizing that the "country of first choice by medical device developers is a key contributor to early patient access to high-quality, safe and effective devices," the Center for Devices and Radiological Health's (CDRH) at the U.S. Food and Drug Administration issued its 2014-2015 Strategic Priorities, which describe their efforts to improve regulatory predictability and device development efficiency in order to "help medical device developers choose the U.S. as the country of first choice for their technologies." While the FDA's efforts seem to focus on encouraging medical device innovation in the U.S., the medical device tax seems to be contradictory to this effort.

Some also argue that while expanding insurance coverage will help drug companies sell more products and bring in new patients for providers and hospitals, it will not help sell more devices because the majority of potential beneficiaries are much older and already covered by Medicare.

Hundreds of companies and trade groups have signed on to letters opposing the tax from industry associations, like the Medical Device Manufacturers Association (MDMA) and AdvaMed. Others have launched significant lobbying efforts to support the tax's repeal, an industry that accounts for $30 million in lobbying expenditures annually since the ACA was passed in 2010. The Center for Responsible Politics has also identified $5.7 million in political contributions on behalf of medical device companies to specific candidates during the 2013-2014 campaign cycle.

4. How are lawmakers responding?

The tax's repeal has been supported by Democrats and Republicans alike. Many opponents cite the Senate's fiscal 2014 budget resolution as an indicator of support - drumming up 79 supporters for repeal, including 33 Democrats. However, the resolution "was non-binding and viewed as a free vote to show displeasure with an unpopular aspect of the health law." The tax's repeal has garnered outspoken support from Orrin Hatch (R-UT) and Mitch McConnell (R-KY), as well as Elizabeth Warren (D-MA), Al Franken (D-MN), Amy Klobuchar (D-MN) - Democrats with notably high concentrations of medical device companies in their states. The House has approved the repeal of the device tax three separate times in the past two years, including as recently as September 2014. The White House has historically opposed these efforts, but President Obama recently indicated he would entertain the idea.

A report from the nonpartisan Congressional Research Service, released last week, concluded that the tax is unlikely to hurt the profits of device companies, estimating that it will reduce industry output and employment by no more than .2 percent. CRS states, "The effect on the price of health care, however, will most likely be negligible because of the small size of the tax and small share of health care spending attributable to medical devices." A separate report from Ernst & Young last month finds that domestic revenues for medical technology firms grew 4 percent to $336 billion in 2013, the first year the tax went into effect - about the same rate from 2012, indicating that the industry seems financially stable for now.

Editor’s note: This post was originally featured in RealClear Markets on November 12, 2014. Click here for the original posting.

      




medical

Defining and measuring innovation in a changing biomedical landscape

Event Information

October 14, 2015
9:00 AM - 2:30 PM EDT

Washington Plaza Hotel
10 Thomas Circle, NW
Washington, DC 20005

The biomedical innovation ecosystem continues to evolve and enhance the processes by which treatments are developed and delivered to patients. Given this changing biomedical innovation landscape, it is imperative that all stakeholders work to ensure that development programs, regulatory practices, and the policies that enable them are aligned on and achieving a common set of goals. This will require a thorough reexamination of our understanding of biomedical innovation – and the subsequent ways in which we seek to incentivize it – in order to more effectively bridge research and analysis of the process itself with the science and policy underpinning it.

Traditional research into the efficiency and effectiveness of drug development programs has tended to focus on the ‘inputs’ and process trends in product development, quantifying the innovation as discrete units. At the opposite end of the research spectrum are potential measures that could be categorized as “value” or “outcomes” metrics. Identifying the appropriate measures across this spectrum – from inputs and technological progress through outcomes and value – and how such metrics can be in conversation with each other to improve the innovation process will be the focus of this expert workshop. On October 14, the Center for Health Policy at Brookings, under a cooperative agreement with the U.S. Food and Drug Administration, convened a roundtable discussion that engaged key stakeholders from throughout the innovation ecosystem to explore the factors and characteristics that could improve our understanding of what constitutes modern “innovation” and how best to track its progress.

Event Materials

       




medical

The medical marijuana mess: A prescription for fixing a broken policy

In 2013, Patrick and Beth Collins were desperate. Thirteen‐year‐old Jennifer, the younger of their two children, faced a life‐threatening situation. In response, the Collins family took extreme measures—sending Jennifer thousands of miles away in the company of her mother. Beth and Jennifer became refugees from a capricious government whose laws threatened Jennifer’s health, the family’s…

       




medical

Health care priorities for a COVID-19 stimulus bill: Recommendations to the administration, congress, and other federal, state, and local leaders from public health, medical, policy, and legal experts

       




medical

Physician Social Networks and Geographic Variation in Medical Care

CSED Working Paper No. 33: Physician Social Networks and Geographic Variation in Medical Care

      
 
 




medical

Hutchins Roundup: Medical billing, young firms, and more

Studies in this week’s Hutchins Roundup find that collecting payments from insurers is highly costly for health care providers, superstar firms account for less of productivity growth than previously thought, and more. Want to receive the Hutchins Roundup as an email? Sign up here to get it in your inbox every Thursday. Costly billing hassles…

       




medical

American Medical Association urges shift to plant-based hospital food

Between planetary and personal health, there's a lot to be said for eating a lot less meat.




medical

Toronto nurse turns medical waste into a stunning mural

After 28 years of collecting lids, tabs, and connectors, Tilda Shalof was ready to turn them into a work of art.




medical

This high-tech, grow-it-yourself medical cannabis kit is as easy as using an app

Seedo, creators of automated consumer grow labs, will shortly plant a seed in the U.S. medical marijuana market.