Fraud Report-Criminals in the U.S. Healthcare System

Fraud Report U.S. Healthcare-Corporate Greed and Justice Intervention

Americans have been conditioned to view healthcare fraud as a crime perpetrated by Medicaid cheats, but the curtain is being pulled on corporate fraud, which costs healthcare consumers so much more than welfare opportunists.  This week, criminal trials begin for executives at two different companies, Allergan’s Warner Chilcott unit, a pharmaceutical company and Johnson and Johnson, a medical device manufacturer, at the federal court in Boston.[1] The justice department decided the billions in corporate fines were not sufficiently deterring corporate misconduct in healthcare and has started to pursue criminal charges for white collar criminals who here-to-for thought they could pay a fine and walk. The individuals in the chart below have been indicted by a federal grand jury and will stand trial:

Corporate Fraud

Pharmaceutical Industry	Allergan subsidiary Warner Chilcott has already plead guilty to healthcare fraud and paid a $125,000,000 fine	W. Carl Reichel, ex-president of Warner Chilcott	Kickbacks (bribes) to healthcare providers	Applies to Atlevia, for osteoporosis and other drugs
Medical Device Industry	Johnson & Johnson subsidiary, Acclarent	William Facteau, former CEO and Patrick Fabian, former Vice President of Sales	Promoting unauthorized use of a sinus opening device (fraud) and securities fraud for nondisclosure	Spiking sales for a balloon device used for sinus procedures by promoting it as a steroid delivery device to inflate share price

(Division April 15, 2016)[2]

Fraud Report- Criminals in our Healthcare system

Due to the plethora of convicted criminals in healthcare, each table will show the crime by classification for 2016 and is all drawn from the U.S. Health & Human Services Fraud Report. (Services 2016) Also, only individuals working in the healthcare industry who committed the crimes are listed, not other nefarious opportunists. Also, Stark Law violations, which create fines for hospitals which have privileged financial relationships with community based physicians are not listed because that would generate an entire article.

Drug Dealers

Prescription Drug Fraud, money laundering, conspiracy	Kentucky Anesthesiologist	Convicted May 12th, Jaime Guerrero; sentenced to 100 months (8.3 years) in prison	Unlawful distribution of a controlled substance	Prescribing Hydracodone without medical necessity
Prescription Drug Fraud, money laundering	Pennsylvania Drs. Alan Summer, Azad Khan, Keyhosrow Parsia	Indicted May 11th	Unlawful distribution of a controlled substance	Unlawful sale of Klonopin and Suboxene for cash
Fraudulent prescriptions	Pennsylvania, Dr. John Terry	Sentenced-plea bargained January 5th	Fraudulent prescriptions	Unlawful prescriptions for oxycodone
Fraudulent prescriptions worth $20,000,000	California, Dr. Kenneth Johnson	Sentenced to a 108th months (9 years) prison term January 6th	Fraudulent prescriptions written out of sham medical clinic in Glendale	Pre-signed thousands of prescriptions
Fraudulent prescriptions	West Virginia, Dr. Jose Jorge Abbud Gordinho	Plead guilty January 7th	Fraudulent prescriptions	Unlawful prescriptions for hydrocodone
Conspiracy to distribute narcotics	New York, Dr. Kevin Lowe	Found guilty May 4, 2015, sentenced January 11, 2016 to 144 months in prison (12 years)	Owned Astramed, a clinic in the Bronx, NYC	Unlawful distribution of oxycodone

Medicare Fraud-Overbilling or False Claims

These criminals are listed in descending order from the beginning of 2016

Defrauding Medicare of $4,500,000	California	Hovik Simitian, sentenced to 78 months (6 ½ years) in prison, January 2nd	Included 3 clinics: Columbia Medical, Safe Health, and Life Care	Fraudulent claims
Over billing Medicare $7,800,000	Tennessee Nashville Pharmacy Services, LLC	Kevin Hartman, majority shareholder agreed to the plea		Over billing for Aids and HIV medications
Fraudulent claims of $70,000,000	Florida	Transportation Services Providers Inc. Damian Mayol, sentenced January 8th	Included 3 clinics and involved mental health patients	Involved kickback payments and billing for unnecessary services
Fraudulent claims, $63,000,000	Florida	Nery Cowan plead guilty January 14th, sentenced on March 25th to 60 months (5 years) in prison	Ms. Cowan was a consultant and Medicare biller for Greater Miami Mental Health Center	Directed kickback payments and received a percentage of Medicare reimbursements
Fraudulent claims, $375,000,000	Texas	Patricia Akamnonu, RN sentenced to 10 years and ordered to pay $25,000,000 in restitution on January 19th	Founder of Ultimate Care Home Health Services Inc.	Fraudulent claims for home health care services
Fraudulent claims, $57,000,000, healthcare fraud, wire fraud, conspiracy	Florida	Khaled Elbeblawy, convicted of fraud, January 22, sentenced to	Jem Home Health Care, Healthy Choice Home Health Care, Willsand Home Health Agency Inc.	Fraudulent claims for home health care services

Medicare Fraud-Unnecessary Medical Services

False Claims	Virginia, Bostwick Laboratories	Dr. David G. Bostwick, sentenced January 8th, ordered to pay $3,700,000 fine	False claims for unnecessary services and kickbacks to physicians	Unnecessary cancer detection services
False Claims	Nationwide rehabilitation services provider, Kindred Rehabcare	Company Agreed to pay $125,000,000 to the government on January 12th	False claims for skilled nursing facility services	False claims for unnecessary rehabilitation services
False Claims	Illinois, convictions for officers of Mobile Doctors had already been procured	Dr. Banio Koroma, Mobile Doctors convicted of federal fraud, on January 25th, sentencing set for June 6th	Certified patients were home bound when they were not	False claims for unnecessary home health care services
False Claims for $1,500,000	California	Amalya Cherniavsky, owner of California Medical Equipment Supply Company	False claims for unnecessary services	Kickbacks for prescriptions for unnecessary medical equipment

[3]

As you may have surmised, there are so many fraud cases, I have only been able to illustrate the month of January 2016 in this article, so certainly this topic needs revisiting on a regular basis. Let’s all give a big thank you to the hard working folks at the Medicare Fraud Strike Force-your government dollars working effectively to cut fraudulent waste in the healthcare system. The next time you hear someone complaining about all of the focus on fraud in the healthcare system and how it is unnecessary, feel free to refer them to this handy summary. And this is the healthpolicymaven signing off wishing you fully informed consent in all of your health care decision making.

The healthpolicymaven is a trademark of Roberta E. Winter and Praevalere Inc. Feel free to share this article virally. Roberta Winter is the author of http://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972

Works Cited

Division, Federal Drug Agency-Enforcement. April 15, 2016. Former Acclarent, Inc. Executives Charged with Securities Fraud and Crimes Related to Sale and Distribution of Medical Devices. United States Department of Justice Proceeding, U.S. Health and Human Services, Boston: U.S. Department of Health and Human Services. Accessed May 23, 2016. http://www.fda.gov/ICECI/CriminalInvestigations/ucm443650.htm.

Loftus, Peter. 2016. "Ex-Health Executives Go on Trial." Wall Street Journal, May 23: B1-B2.

Services, U.S. Health & Human. 2016. "Healthcare Fraud Report." Health & Human Services. Accessed May 23, 2016. http://oig.hhs.gov/fraud/enforcement/criminal/.

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[1] Loftus, Peter. 2016 “Ex-Health Executives Go On Trial.” Wall Street Journal, May 23: B 1-2

[2] http://www.fda.gov/ICECI/CriminalInvestigations/ucm443650.htm

[3] https://www.justice.gov/opa/pr/president-miami-based-transportation-company-sentenced-60-months-prison-role-70-million

Good News For Consumers From Global Drug Manufacturers

U.S. residents pay too much for their prescription drugs and medical supplies, which reflects on our cost-plus reimbursement practice which is fueled through insurance reimbursement, whether government or private sector. This article reviews some pharmaceutical companies which are offering greater transparency and value for their products.

Transparency from a Drug Manufacturer

AstraZeneca, PLC, a UK pharmaceutical company recently published the results of its study on the blood thinner, Brillanta, which was used to prevent secondary heart attacks for stroke patients, and declared it performed no better than aspirin. [1] Stop the presses, this may not be a first, but it is unusual for a drug company to declare that its product is not effective, but then again this is in Europe where drug manufacturers can’t market their products directly to consumers and governments contract with pharmaceutical providers directly. This level of transparency should be encouraged in the U.S. where clinical study results are often buffered to enhance the perception of the drug intervention, as opposed to stating statistical significance in the absolute. By that I mean, how many people would have to be treated with the drug to show a statistically reliable difference and what would that difference mean to a realistic population of potential users? Dr. Norman Hadler of the University of North Carolina has written extensively about the misinformation that is published about clinical studies and subsequent practices which do not improve health.[2]

Generic Drug Manufacturers Are Investigating Small Market Diseases for Drug Development

When the patents expire on pharmaceuticals, any approved drug manufacturer can start to develop its off-label version of the medicine. The three largest manufacturing centers for generic medications are in India, Israel, and the United Kingdom. Indian companies have applied to the U.S. Food and Drug Administration for pharmaceutical product licensing at an increasing rate. Sun Pharmaceuticals in India, has FDA approval for a treatment of the rare blood disease, myelo-dysplastic syndrome. Another Indian drug company, Dr.  Reddy’s Laboratories (yes, this is the real name) has FDA approval for a skin spray for plaque psoriasis (a skin disease) and it is working on an improved injection for treatment of migraines.[3] Indian pharmaceuticals companies have increased their research and development budgets for new drug treatments for diseases which are being ignored by the U.S. pharmaceutical industry.By working with existing compounds from expired patents scientists can save time when developing some of the new treatments. Indian companies are devoting 17% of their budgets to research and development which exceeds what the large U.S. pharmaceutical companies spend, typically less than 10%. Because of the direct to consumer marketing and other financial incentives, the drug companies spend much more of their annual budgets on marketing, than on research. Most new research is done at universities in the U.S. and is funded through grants by the U.S. National Institutes of Health.  India does not have a government agency, like the National Institutes of Health to invest in medical research, but it does partner with the NIH on some projects.
https://www.washingtonpost.com/news/wonk/wp/2015/02/11/big-pharmaceuti

Moon Shot for Treatment of Melanoma

More than a third of patients with advanced melanoma (skin cancer) survived five years with a new molecular drug treatment which makes T cells target the cancer. The study by Bristol-Meyers Squibb, followed 107 people with advanced melanoma to determine the effects of Opdivo.The drug has the potential to double the number of  five-year survivors for people with advanced melanoma. The U.S. Food and Drug Industry approved the drug for treatment of melanoma in 2014. Study results were presented at the American Association for Cancer Research Annual Meeting.[4] http://news.bms.com/press-release/aacr/first-presentation-overall-survival-data-opdivo-nivolumab-shows-significant-survi

And this is the healthpolicymaven signing off with useful information for healthcare consumers. The healthpolicymaven is a trademark of Roberta E. Winter and Praevalere Inc. Feel free to share this article virally. Roberta Winter is the author of Unraveling U.S. Healthcare-A Personal Guide, Rowman & Littlefield, 2013.

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[1] Denise Roland, AstraZeneca Says Its Blood Thinner Is No Better Than Aspirin, Wall Street Journal, March 24, 2016

[2] Norton M. Hadler, The Citizen Patient, University of North Carolina Press, 2013

[3] Suryatapa Bhattacharya, Indian Drug Makers Target Niche Markets, Wall Street Journal, April 19, 2016

[4] Drug Seems to Extend Survival for Advanced Melanoma, Medline Plus, U.S. National Library of Medicine, April 18, 2016

Diabetes Research-Are We Close To A Cure?

The Scourge of Diabetes and Research for a Cure

This article is about Type 1 diabetes, which occurs in childhood or young adulthood and is not diet related. My brother, Russell was struck with Type 1 diabetes when he was 3 years old, shortly after his exposure to chicken pox (from his older school-age siblings). For the next 42 years and 345 days, his life was hellish. When he was a teenager a physician told him he wouldn’t live to be 30. His life can be summed up in numbers; 3 amputations, 3 kidney failures, 1 kidney-pancreas transplant, 3 times a week to the dialysis center, 1 heart surgery, 1 marriage, 1 divorce, 0 children,  and one final note on the ventilator. His long suffering and tragic result does not have to be your story or that of your loved one, because the Benaroya Research Institute has been working on a cure for diabetes for decades and is on the verge of a break through. The Benaroya Research Institute is an example of one of the things that is right about U.S. healthcare-we still have money to invest in research, which can be funded through private foundations, in concert with the National Institutes of Health, a federal agency.

T Cells and the Tetramer Lab

Last week, I had the opportunity to tour a scientific lab and listen to a scientist who has been conducting research to cure diabetes for fifteen years. In the Tetramer lab, blood studies are conducted on thymus or T cells, because they are most closely associated with the bodies’ endocrine functions. T cells have differing characteristics which influence cell behavior, such as whether the bodies’ immune system starts to attack itself. Research on T cell behavior aims to identify the causes of the cellular war fare and deprogram these aberrant cells from this destructive behavior. The Benaroya Research Institute or BRI has been using this same cell line for research since the 1980’s. Tetramer is a pink fluid and 4 cells are optimal to complete scientific tests on the cellular matter. BRI now has enough human bio samples to account for 97% of the U.S. population.  Though BRI is conducting research on links to cellular characteristics for Type 1 diabetes, rheumatoid arthritis, and other autoimmune diseases are also being studied, because of the link to cellular behavior attacking the immune system.  Diseases which are under active research at BRI include:

• ·         Type 1 diabetes

• ·         Rheumatoid arthritis

• ·         Multiple sclerosis

• ·         Inflammatory bowel disease

• ·         Asthma

Diagnosing Risk of Diabetes Before Symptoms Are Visible

One of the most promising areas of research is looking for ways to reprogram T cells before diabetes starts. Currently diabetes is thought to have three stages, where the first, like heart disease, shows no symptoms, and blood sugar levels are normal. However, in this dormant stage the immune system has already started attacking cells which control endocrine functions. In stage two, the blood sugar levels are abnormal, and finally in stage three, the symptoms of diabetes are present, which eventually lead to the pancreas ceasing to supply insulin. By conducting clinical trials using donated blood, scientists are able to determine an individual’s risk for diabetes and other autoimmune diseases. Just like cancer, by diagnosing the presence or vulnerability for a disease earlier, less damage is done, and the prognosis for the patient is better.

Gene Editing

Benaroya Science Institute is working on gene editing which involves using cells from study participants who have working pancreas and then engineering the same cell responses in patients who have nonfunctioning pancreas. The updated cells are then injected back into the patient’s blood stream and they begin their recovery work on the T cell attacks in the pancreas. This is like a checkmate on internal gene war fare. T cell therapy is a method of using revamped thymus or T cells to correct the autoimmune defects in the body. By engineering targeted gene responses, specific to each disease, only aspects related to that disease are suppressed, not the entire immune system. This of course makes the treatment much less invasive.

What You Can Do To Help

If you want to help cure Type 1 diabetes and continue the research that Benaroya Research Institute is doing, here are some things you can do:

·         Sign up to participate in the TrialNet study if you are a family member of someone diagnosed with Type 1 diabetes (T1D). This means your blood will be tested for markers of diabetes and you will be assessed for risk and monitored. There is no cost to participate and all of the testing is free and can be done anywhere in the world.

• ·         Adults of primary family members with (T1D) must be under 45 to participate in the study and have a parent, child, brother or sister with type 1 diabetes.

• ·         Secondary family members of people with (T1D) must be 1 to 20 years old and have a niece, nephew, aunt, uncle, grandparent, half-brother, half-sister, or cousin with type 1 diabetes.

• ·         Make a donation to the BRI Biobank for cellular research in anyone of 12 disease vectors.

• ·         Donate money to the Benaroya Research Institute.

• ·         Sponsor a fundraiser for the Benaroya Research Institute.

• ·         Tell others about the research at the Benaroya Research Institute.

For more information on the work at the Benaroya Research Institute (BRI), go to their web site www.BenaroyaResearch.org or call 206-342-6500. https://connect.benaroyaresearch.org/donate

Who knows, maybe in your lifetime we will have a vaccination for diabetes?

The information in this article is based on materials provided by the Benaroya Research Institute and my tour of the science lab on March 25, 2016.  This article was written by Roberta E. Winter, who publishes under the trademark, healthpolicymaven. She is the author of http://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972