İlaç konusunda sahtekarlık hemen her ülkede gittikçe artan bir hızla devam etmekte. Defalarca söylediğimiz gibi ilaç sanayiinde yeni molekül keşfi azaldıkça sahtekarlık artmakta ve bazı firmalar hissedarlarını tatmin için bu yolu tercih etmekte. Bunun son örneklerinden birisi dünyanın en büyük jenerik ilaç firmalarından Hintli Ranbaxy’nin yaptıkları. Ranbaxy’nin ABD de kurtlar sofrasında kendine yer bulmak için sahte biyoeşdeğerlik dosyaları hazırlayarak bir taraftan FDA’i diğer taraftan hastaları kandırdığı iddia edilmekte. Bununla işgili olarak ABD adalet bakanlığı Ranbaxy hakkında tahkikat başlatırken, diğer taraftan ABD temsilciler meclisi FDA hakkında soruşturma başlatmıştır (detaylar haberler bölümünde). Hatırlanacağı gibi benzer olay bundan birkaç sene önce Türkiyede de olmuş (AllPharma olayı) ama bazı biyoeşdeğerlik çalışmalarının tekrarlatılması dışında, yapanların yanına kar kalmıştı.
ABD de 1863 de, sivil savaşın en şiddetli olduğu dönemde, “False Claims Act, FCA-sahte hak talep etme yasası” (daha sonra Lincoln kanunu olarak anılmış) ve vatandaşlara devleti dolandıranlara karşı dava açma hakkı tanınmıştır. Yani kişiler devlet adına, sahtekarlık yaparak devleti zarara uğratanlar hakkında dava açabilmekte ve davayı kazandıklarında elde edilen tazminatın %10-30’un kendilerine alabilmekte. Buna “Qui Tam” hakkı denilmekte. Qui Tam Latince “Qui tam pro domino rege quam pro si ipso hac parte sequitur” un kısaltması olup “her kim kırak adına birisini dava ederse ayni zamanda kendisi içinde dava etmiş sayılır” demekmiş…
Yolsuzlukları ihbar eden kişilere “Relator veya whistleblower - muhbir veya çalıştığı bölümdeki yolsuzlukları kamuoyuna duyuran devlet memuru” denilmekte. Yenilenen FCA kanunda cezalarda artırıma gidilmiş ve sahtekarların devlete verdikleri zararın 3 mislini ödemeleri şartı getirilmiştir. Türkiyede de 1262 sayılı kanunda cezalar benzer şekilde belirtilmiş (..temin etmek istediğimenfaatin 2 mislinden az olmamak üzere.. gibi) fakat bu sene yapılan değişiklikle bu madde sulandırılmış ve sahtekarlıkların cezaları hafifletilmiştir, herkes gider Mersine biz gideriz tersine… (Madde 18:Müstahzarları taklit ederek bunların tedavi vasıflarını azaltacak veya kaybedecek surette imal edenler veya bu suretle imal edildiğini bilerek satan, satılığa arzeden veya sattıranlar üç aydan bir seneye kadar hapis ve temin ettikleri veya etmek istedikleri menfaatin iki mislinden aşağı olmamak üzere ağır para cezasiyle cezalandırılırlar.Şu kadar ki bu para cezası 200 liradan aşağı olamaz.Tekkerrürü halinde ruhsatı geri alınır.
Değişik(08/02/2008 – 5728/45.md):Müstahzarları taklit ederek bunların tedavi vasıflarını azaltacak veya kaybedecek ya da kullananların sıhhatine az veya çok zarar verecek surette imal edenler veya bu suretle imal edildiğini bilerek satan, satışa arzeden veya sattıranlar, Türk Ceza Kanunu veya diğer ilgili kanun hükümlerine göre cezalandırılır.)
Sonuç olarak ABD de “FCA” kanunu sayesinde devlet 1986 dan beri 20 milyar dolar kazanmıştır. 2007 Yılında ABD 2 milyar doları geri almış ve bunun 1.45 milyar doları Qui Tam muhbirleri sayesinde olmuştur. 2007 deki olaylara sağlıkla ilgili firmalardan bazı örnekler:
- 328 Milyon dolar BMS ve onun jenerik bölümü Apothecondan, kanunsuz fiyatlandırma ve pazarlama faaliyetleri dolayısı ile
- 311 Milyon dolar 4 kalça ve diz protez firmasından (Zimmer, Inc., Depuy Orthopaedics, Inc., Biomet Inc. and Smith & Nephew, Inc) ortopedislere rüşvet vermekten
- 180 Milyon dolar Sanofi-Aventisten, ilaç fiyatlarını şişirmekten (muhbir 33 milyon dolar almıştır)
- İllinois baş savcısı 48 ilaç firması hakkında ilaç fiyatlarınde sahtekarlık yaptıkları için dava açtı (Medicare hastaları yüzmilyonlarca dolar fazla ilaç parası ödemiş), Alabama da 79 ilaç firması için benzer dava açıldı, 19 eyalette davalar birbirini takip etmekte.. Daha fazla bilgi isteyenler aşağıdaki tabloya bakınız!
Benzer olaylar bundan birkaç gün önce sayın Çalışma Bakanı tarafından açıklandı ve sosyal güvenlik kurumunun hastaneler tarafından milyonlarca YTL dolandırıldığını açıkladı. Bekleyelim görelim bakalım bunlar herzaman olduğu gibi yapanların yanına kar mı kalacak yoksa devletin zararları geri alınacak mı?.. Ya 2 milyar dolarlık ilaç israfına kim dur diyecek????
ctulunay@medicine.ankara.edu.tr
Company |
Amount in Millions $ |
Date |
Nature of the fraud |
Medicare |
Medicaid |
Bristol-Myers Squibb |
328 |
9/28/2007 |
A total $515 million settlement, with $328 million to be paid under the Federal False Claims Act, and the state's getting $187 million. Fraud charges included off-label marketing, kickbacks, AWP drug pricing violations and several other frauds involving 50 drugs and a total of seven qui tam cases. |
X |
X |
Amerigroup |
172 |
3//14/2007 |
Judgment for $334 million including penalties. Amerigroup cherry-picked patients in violation of its HMO Medicaid contract, purposely avoided women in their third trimester of pregnancy because they cost more to insure. Note that this judgment is on appeal and reflects a $190 million penalty on top of a $144 million jury verdict. |
|
|
Combined settlement with four orthotics companies: Smith & Nephew, Biomet, Zimmer, DePuy (Johnson & Johnson) |
310 |
9/27/2007 |
$310 million total settlement of broad practice of kickback in the orthotics industry. Zimmer to pay 169.5 million, DePuy to pay $84.7 million, Smith and Nephew to pay $28.9 million, Biomet to pay $26.9 million. Stryker agreed to be monitored, but has entered no civil settlement. |
|
|
Aventis (sanofi-aventis) |
180 |
9/17/2007 |
Medicaid Average Wholesale Price case involving the anti-nausea drug Anzemet. Total settlement was for $190 million |
|
|
Medco |
155 |
10/24/2006 |
Shorting prescriptions, canceling prescriptions to avoid paying non-performance penalties, soliciting and accepting kickbacks from pharmaceutical manufacturers to favor their drugs, and paying kickbacks to health plans to obtain business. |
X |
X |
Purdue Pharma |
140.5 |
5/10/2007 |
Company "mislabeled" the drug saying it was less addictive than it was. This is a $634.5 million settlement, with $276 million to be forfeited to the United States, $160 million allocated to federal and state government agencies to resolve false claims for government healthcare programs and $130 million will go to resolving private civil claims. Of the 160 million to go to State and Federal FCA claims, $19.5 million is to go to the states. |
|
|
Omnicare / Specialized Pharmacy Services (Michigan) |
52.5 |
10/5/2006 |
Improper billing, failure to credit Medicare for returned drugs, billing drugs for dead patients. |
|
X |
Omnicare |
49.5 |
11/14/2006 |
Illegal switching of generic pill to capsule forms of Zantac (ranitidine) in nursing homes and other facilities. |
|
|
InterMune, Inc. |
36.8 |
10/27/2006 |
Illegal off-label promotion of Actimmune. |
X |
X |
Lourdes Perez, Provident Home Health Care Services Inc. and Tri-Regional Home Health Care Inc. |
33.8 |
10/11/2006 |
Medicare "bill mill" in which Medicare was billed for patients who were not homebound and for services her companies did not perform, creating false medical records to support the claims. |
X |
|
Maximus Inc. |
30.5 |
7/24/2007 |
Maximus billed DC Medicaid for targeted case management services that it either did not provide or had no records for. |
|
|
Robert I. Bourseau, Dr. Rudra Sabaratnam, and their two single-employee corporations, RIB Medical Management Services, Inc., and Navatkuda, Inc., |
23.8 |
10/2/2006 |
Used false cost reports to bill Medicare for unreimbursable services at the Chula Vista psychiatric hospital formerly known as Bayview Hospital & Mental Health Systems. |
X |
|
Harris County Hospital District |
15.5 |
3/28/2007 |
Medicare Secondary Payer violations plus billing Medicaid for patients under custody of law enforcement. |
|
|
Larkin Community Hospital in Miami and its current and former owners, Dr. Jack Michel, Dr. James Desnick, Morris Esformes and Philip Esformes |
15.4 |
11/30/2006 |
Kickbacks |
X |
X |
Jackson Memorial Health System |
14.25 |
12/20/2006 |
Jackson Memorial was deliberately making use of unallowable or reopened cost reports, getting wrongful overpayments as a result. |
X |
|
Cell Therapeutics |
10.5 |
4/18/2007 |
Off-label marketing of Trisenox billed to Medicare. |
|
|
Intergris Baptist Medical Center |
10 |
11/28/2006 |
Inflated costs for organ transplants |
|
|
Medicis Pharmaceutical |
9.8 |
5/8/2007 |
Off-label marketing: Company promoted the use of a topical anti-fungal, Loprox, for diaper rash on children under the age of 10, without approval by the Food & Drug Administration. |
|
|
American Medical Response Inc. |
9 |
10/5/2006 |
Ambulance services fraud. |
X |
|
SCCI Health Services Corporation, and its subsidiary, SCCI Hospital Ventures Inc |
7.5 |
1/7/2007 |
Kickback and self-referral (Stark violations) |
X |
|
Raritan Bay Medical Center |
7.5 |
3/16/2007 |
Purposefully inflated outlier charges for inpatient and outpatient care to make these cases appear more costly than they actually were. |
|
|
Atlanta's Northside Hospital |
5.75 |
10/20/2006 |
Kickbacks |
|
|
Keystone Mercy Health Plan |
5 |
10/27/2006 |
Medicaid HMO Kept Medicaid overpayments |
|
X |
St. Elizabeth Regional Medical Center (NE) |
4 |
10/31/2006 |
Used false cost reports to overbill l Medicare for neonatal and burn units. |
|
|
Scooter Stores |
4 |
5/14/2007 |
Settlement includes $4 million in cash and $13 million in foregone Medicare payments to settle charges the company billed Medicare medically unnecessary power wheelchairs. |
|
|
HealthSouth Corporation |
4 |
11/3/2006 |
HealthSouth submitted fraudulent Medicare claims for prosthetic and orthotic devices - such as artificial limbs and braces - used to treat HealthSouth hospital inpatients |
X |
|
Our Lady of Lourdes Regional Medical Center |
3.8 |
5/9/2007 |
Billing Medicare, Medicaid and private insurance providers $2.5 million for unnecessary cardiac procedures, such as angiograms and angioplasties, on more than 70 patients. |
|
|
Orphan Medical/ Jazz Pharmaceuticals Inc |
3.75 |
7/13/2007 |
Aggressive marketing of Xyrem (GBH, the "date rape" drug) for unapproved use. Part of a total settlement of $20 million, including criminal. |
|
|
Cabrini Medical Center |
3.4 |
3/29/2007 |
Kickbacks billed as administrative services for referral of patients. |
|
|
Korrect Optical |
3.25 |
1/25/2007 |
Korrect Optical submitted false claims to the Department of Veteran Affairs ( VA )through ophthalmic prescriptions for eyewear for veterans. |
|
|
Dr. Daniel Nixon and other board members of the Institute for Cancer Prevention, Tatum, LLC and Weiser, LLP |
3.2 |
1/17/2007 |
Unlawful receipt and use of federal grant money. |
|
|
Dey |
2.8 |
4/26/2007 |
Settle charges of price inflation and defrauding Mass. Medicaid program (AWP). |
|
|
Rural/Metro Corporation |
2.5 |
6/11/2007 |
Kickback for referrals |
|
|
David Rommel |
2.48 |
11/13/2006 |
Dental practice fraud. Won by summary judgment. |
|
|
Danbury Hospital (CN) |
2.4 |
10/27/2006 |
Self-reported upcoding for septicemia, respiratory failure, respiratory infections and inflammations. |
X |
|
University of Miami Medical School |
2.2 |
12/27/2006 |
UM sometimes billed for critical care services when patients were not critically ill or where critical services were not rendered. |
X |
X |
Loma Linda Behavioral Medicine Center (Loma Linda BMC) in Redlands |
2 |
4/26/2007 |
Fraudulently overbilled federal health insurance programs by manipulating cost reports. |
|
|
O'Hara Regional Center for Rehabilitation, Health Care Management Partners, ORCR Inc., Solomon Health Management, Solomon Health Services |
1.9 |
10/5/2006 |
Abuse and neglect and substandard nursing home services. |
|
X |
Emeritus Corp |
1.86 |
8/30/2007 |
False and inaccurate billing to the Texas Medicaid program. |
|
|
Crawford and Company |
1.36 |
10/11/2006 |
Billing the government for health care services to federal employees at rates set by Crawford managers, rather than billing the actual time spent performing that service. |
|
|
Ciena Healthcare Management |
1.25 |
8/20/2007 |
Improperly billed Medicaid and Medicare for inadequate care of and services to residents at four metro Detroit nursing homes. |
|
|
Lancaster Community Hospital |
1.2 |
6/8/2007 |
Knowingly overbilled Medicare for physical therapy costs. |
|
|
Lakewood Cheder School |
1.2 |
10/31/2006 |
False information to obtain funds for preschool lunch program. |
|
|
Robert E. Eberhart and Jonathan Holzaepfel, orthopedic surgeons and partners in Seacoast Trust, and Thomas King |
1 |
3/8/2007 |
HealthSouth paid higher than normal rent equivalent to income from referrals made by the doctors |
|
|
Parkway Hospital, Inc |
1 |
8/14/2007 |
Inflated hospital costs reports. |
|
|
Environmental Management Inc. |
1 |
4/2/2007 |
Overbilling and illegal disposal of chemicals in methamphetamine lab cleanups for DEA. |
|
|
Julio C. Melo, M.D., |
0.984 |
7/23/2007 |
Billed Medicare for Evaluation and Management services that exceeded the number of hours there were in a day. |
|
|
RightCHOICE Managed Care Inc. |
0.975 |
1/31/2007 |
RightCHOICE paid higher fees to physicians serving government0insured patients than for other plans. |
|
|
Comprehensive Cancer Centers |
0.9 |
11/8/2006 |
Upcoding led to overbilling of Medicare for CCC services at Desert Regional Medical Center (owned by Tenet) |
X |
|
Iftakhar Khan and Amjad Khan |
0.825 |
1/9/2007 |
Owners of Livonia-based Michigan Rehabilitation and Pain Management fraudulently billed Medicare. |
X |
|
Green Valley Pavilion, LLC |
0.55 |
5/14/2007 |
Forging and altering patient charts to maximize reimbursement from Delaware's Medicaid Program |
|
|
Oregon Imaging Center |
0.51 |
12/12/2006 |
Tests not ordered by doctor. |
|
|
John Dempsey Hospital |
0.475 |
6/27/2007 |
Overbilled Medicare for chemotherapy treatment. |
|
|
Colquitt Regional Medical Center |
0.475 |
3/5/2007 |
Overcharged the government for services through CRMC's Home Health Office in Sylvester, GA |
X |
X |
Hillsboro Area Hospital, in Hillsboro, Ill. |
0.3 |
2/7/2007 |
Over billing for the treatment of Medicare beneficiaries who were diagnosed with pneumonia, sepsis, and renal failure. |
X |
|
Beacon Ambulance Company. |
0.219 |
3/29/2007 |
Use of one basic technician and a single Paramedic on ambulance run, and billing for two Paramedics. |
|
|
Riverview Cancer Center |
0.165 |
10/5/2006 |
Upcoding and services not provided |
|
|
Dr. Roberto Ramirez |
0.03 |
12/21/2007 |
False dental billing |
X |
X |
TOTAL |
2117.20 |
|
|
|
|