Showing posts with label Kickbacks. Show all posts
Showing posts with label Kickbacks. Show all posts

Wednesday, October 19, 2016

Nation's Largest Nursing Home Pharmacy to Pay Over $28 Million to Settle Kickback Allegations

Omnicare and Depakote. Who's a thunk it?

US DOJ

The nation’s largest nursing home pharmacy, Omnicare Inc., has agreed to pay $28.125 million to resolve allegations that it solicited and received kickbacks from pharmaceutical manufacturer Abbott Laboratories in exchange for promoting the prescription drug, Depakote, for nursing home patients.  CVS Health Corporation, which is headquartered in Rhode Island, acquired Ohio-based Omnicare in 2015, approximately six years after Omnicare ended the conduct that gave rise to the settlement.
“Every day, elderly nursing home residents suffering from dementia rely on the independent judgment of our nation’s healthcare professionals for their personal care and their medical treatment,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Department of Justice’s Civil Division.  “Kickbacks to entities making drug recommendations compromise their independence and undermine their role in protecting nursing home residents from the use of unnecessary drugs.”
Nursing homes rely on consultant pharmacists, such as those employed by Omnicare, to review their residents’ medical charts at least monthly and make recommendations to their physicians about what drugs should be prescribed for those residents.  The settlement announced today resolves allegations that Omnicare solicited and received kickbacks from Abbott in exchange for recommending that physicians prescribe Depakote, an anti-epileptic drug manufactured by Abbott, to elderly nursing home residents.
According to the government’s complaint, Omnicare disguised the kickbacks it received from Abbott in a variety of ways.  Abbott allegedly made payments to Omnicare described as “grants” and “educational funding,” even though their true purpose was to induce Omnicare to recommend Depakote.  For example, Omnicare allegedly solicited substantial contributions from Abbott and other pharmaceutical manufacturers to its “Re*View” program.  Although Omnicare claimed that Re*View was a “health management” and “educational” program, the complaint alleges that it was simply a means by which Omnicare solicited kickbacks from pharmaceutical manufacturers in exchange for increasing the utilization of their drugs on elderly nursing home residents.  In internal documents, Omnicare allegedly referred to Re*View as its “one extra script per patient” program.  The complaint also alleges that Omnicare entered into agreements with Abbott by which Omnicare was entitled to increasing levels of rebates from Abbott based on the number of nursing home residents serviced and the amount of Depakote prescribed per resident.  Finally, the complaint alleges that Abbott funded Omnicare management meetings on Amelia Island, Florida, offered tickets to sporting events to Omnicare management and made other payments to local Omnicare pharmacies.
In May 2012, the United States, numerous states and Abbott entered into a $1.5 billion global civil and criminal resolution that, among other things, resolved Abbott’s liability under the False Claims Act for alleged kickbacks to nursing home pharmacies, including Omnicare and PharMerica Corp.  In October 2015, PharMerica agreed to pay $9.25 million to the United States and numerous states to resolve civil liability under the False Claims Act for the alleged kickbacks from Abbott.  The settlement announced today resolves Omnicare’s role in that alleged kickback scheme.
“This settlement ensures that some of the most vulnerable amongst us, those suffering from dementia, are provided with the level of care they deserve,” said U.S. Attorney John P. Fishwick Jr. for the Western District of Virginia.  “Families and loved ones who make the difficult decision to place those they care about into a nursing home must do so with the confidence that medical decisions are being made with the interests of the patient in mind, not big drug companies.”
Approximately $20.3 million of the settlement will go to the United States, while $7.8 million has been allocated to cover Medicaid program claims by states that elect to participate in the settlement.  The Medicaid program is jointly funded by the federal and state governments.
“It is disturbing that any health care corporation would pay kickbacks that corrupt the professional medical decision making process in order to pad their profits,” said Special Agent in Charge Nicholas DiGiulio of the Department of Health and Human Services Office of Inspector General (HHS OIG).  “These practices are unacceptable and will not be tolerated.”
The settlement with Omnicare announced today, together with the prior settlements with Abbott and PharMerica, resolves allegations in two lawsuits filed in federal court in the Western District of Virginia by Richard Spetter and Meredith McCoyd, former Abbott employees.  The lawsuits were filed under the qui tam, or whistleblower, provisions of the False Claims Act, which permit private individuals to sue on behalf of the government for false claims and to share in any recovery.  The act also allows the government to intervene and take over the action, as it did in part in this case in May 2014.  The United States filed a complaint-in-intervention against Omnicare in December 2014.  As part of today’s resolution, McCoyd will receive $3 million from the federal share of the settlement amount.
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 Health and Human Services.  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 $31.6 billion through False Claims Act cases, with more than $19.2 billion of that amount recovered in cases involving fraud against federal health care programs.”
This matter was jointly handled by the Civil Division’s Commercial Litigation Branch, the U.S. Attorney’s Office for the Western District of Virginia, HHS-OIG, the Office of the Attorney General for the Commonwealth of Virginia and the National Association of Medicaid Fraud Control Units.
The cases are captioned United States ex rel. Spetter v. Abbott Labs., et al., Case No. 10-cv-00006 (W.D. Va.) and United States ex rel. McCoyd v. Abbott Labs., et al., Case No. 07-cv-00081 (W.D. Va.).  The claims resolved by the settlement are allegations only, and there has been no determination of liability.
16-1203
Updated October 17, 2016


Thursday, June 23, 2016

More Complex Fraud Schemes Bring Doctors Into Legal Fray

fiercehealthpayer antifraud
by Evan Sweeney |
Jun 21, 2016 8:42am



More physicians are facing fraud charges for taking bribes from laboratories, medical devices manufacturers, and drug makers, a reflection of the sheer amount of money that flows through the healthcare industry--and the temptation to get a cut, according to NJ.com.

Thirty-nine physicians have already entered guilty pleas for taking money from New Jersey-based Biodiagnostic Laboratory Services Inc., and more are expected, U.S. Attorney Paul J. Fishman told the news outlet. He says kickback cases have “gotten bigger and more complicated,” and frequently involve dozens of physicians taking bribes.

Last week, Salix pharmaceuticals paid $54 million to settle claims it plied physicians with sham educational programs at high end restaurants.

In a recent $646 million settlement with Olympus Corp., the device manufacturer admitted that it paid hospitals and physicians kickbacks in the form of grants and trips to Japan in order to boost sales of medical equipment. According to Fishman, the government was unable to pursue those physicians because too much time had elapsed.

Experts have no concrete explanation for the influx of physicians accepting kickbacks, although some have pointed to the massive amount of money that flows through the healthcare industry as an financial opportunity that can be hard to ignore.

Laboratory payments to physicians have been a focal point for federal investigators since the Office of Inspector General released a fraud alert indicating those payments qualify as kickbacks. Since then, prosecutors haverevealed a range of schemes, including some involving concert tickets for Justin Bieber and Taylor Swift.

- read the NJ.com article
Read More:
Office of the Inspector General
Paul J. Fishman
Biodiagnostic Laboratory Services
Fraud
Physician Compensation
Pharmaceuticals

Thank You Mr Sweeny and FHPAF.

Tuesday, December 8, 2015

Pfizer-Allergan Merger Marries Companies With History Of Fraud

fiercehealthpayer antifraud
Companies have paid a combined $4.5 Billion in federal settlements

Tuesday, August 6, 2013

J&J Slapped With HHS Subpoena on Nucynta Marketing


Fierce Pharma has;
J&J Slapped With HHS Subpoena on Nucynta Marketing
August 5, 2013 | By 

Johnson & Johnson's ($JNJ) marketing is under the U.S. microscope again. As The Wall Street Journal reports, the feds issued a subpoena for information about J&J's Nucynta promotions, in the government's latest probe of potentially improper drug marketing.

Issued by the Department of Health and Human Services' inspector general, the subpoena is looking for documents and information about sales, marketing and promotional activities on two formulations of Nucynta, an opioid pain reliever. The subpoena specifically mentions payments to doctors, which usually means investigators are looking into potential kickbacks. And it asks for study data on Nucynta's safety, plus any reports or complaints of side effects, the WSJ notes.

A J&J spokeswoman told the Journal that the company is cooperating with the requests.

J&J has experience with subpoenas about its drug marketing. The company is still in the process of wrapping up a years-long investigation into its Risperdal marketing, with the amount of the settlement estimated at more than $2 billion at last report. The company has also disclosed federal inquiries about its marketing of the antibiotic Doribax.

Nor is J&J alone in facing new scrutiny from government watchdogs. Just last month, Novartis ($NVS) disclosed a U.S. Attorney's office demand for information about its multiple sclerosis drug Gilenya, including marketing and payments to doctors. And Forest Laboratories ($FRX) in May disclosed a subpoena from the U.S. Attorney for the Southern District of New York, seeking information about its marketing of the newly approved lung treatment Tudorza Pressair.

A lineup of the world's biggest drugmakers have paid enormous fines and civil penalties to settle other marketing violations and allegations, from GlaxoSmithKline ($GSK) and Pfizer's ($PFE) multibillion-dollar deals on down. Last week, Pfizer's Wyeth unit pleaded guilty and agreed to pay $491 million to resolve a Rapamune marketing investigation.

- read the WSJ article (sub. req.)

Special Reports: Pharma's Top 11 Marketing Settlements | Top Pharma Companies by 2012 Revenues | J&J - Pharma's Top Marketing Settlements

Related Articles:
Novartis under U.S. scrutiny for Gilenya marketing tactics
WSJ: J&J federal Risperdal deal hung up on language over breasts
Risperdal plaintiff's lawyer demands sealed J&J docs from FDA
Feds subpoena Forest Labs in Tudorza Pressair investigation


Thank You Ms Staton and Fierce Pharma.


here's wiki on nucynta

Saturday, April 20, 2013

Hospital CEO, CFO, Arrested In $2 Million Kickback Scheme

And those Medical Ethics just keep rolling in.

The United States Department of Justice has;

http://www.justice.gov/usao/iln/pr/chicago/2013/pr0416_01.html

FOR IMMEDIATE RELEASEApril 16, 2013

Sacred Heart Hospital Owner, Executive and Four Doctors
Arrested in Alleged Medicare Referral Kickback Conspiracy

CHICAGO – The owner and another senior executive of Sacred Heart Hospital and four physicians affiliated with the west side facility were arrested today for allegedly conspiring to pay and receive illegal kickbacks, including more than $225,000 in cash, along with other forms of payment, in exchange for the referral of patients insured by Medicare and Medicaid to the hospital.
Agents from the FBI and the U.S. Department of Health and Human Services Office of Inspector General today also began executing search and seizure warrants in connection with an ongoing investigation of alleged Medicare and Medicaid fraud schemes at the hospital involving emergency room evaluation, testing and observation services that were not medically necessary, as well as medically unnecessary sedation, intubation and tracheotomy procedures performed on patients. Approximately $2 million in Medicare reimbursement payments was seized today from various bank accounts.
Arrested were EDWARD J. NOVAK, 58, of Park Ridge, Sacred Heart’s owner and chief executive officer since the late 1990s; ROY M. PAYAWAL, 64, of Burr Ridge, executive vice president and chief financial officer since the early 2000s; and Drs. VENKATESWARA R. “V.R.” KUCHIPUDI, 66, of Oak Brook, PERCY CONRAD MAY, JR., 75, of Chicago, SUBIR MAITRA, 73, of Chicago, and SHANIN MOSHIRI, 57, of Chicago.
Sacred Heart Hospital is a 119-bed acute care facility located at 3240 West Franklin Blvd., in Chicago. Approximately 40 in-patients were in the hospital this morning, and representatives of the HHS Centers for Medicare and Medicaid Services (CMS) were on site and coordinating with the Illinois Department of Healthcare and Family Services to ensure continuity of patient care.
“These charges and the affidavit’s other allegations outline a kickback conspiracy to bribe doctors to refer patients to Sacred Heart where they would be treated in in an environment in which the quality of care and appropriate medical analysis were less important than maximizing the numbers of patients funneled into the hospital,” said Gary S. Shapiro, United States Attorney for the Northern District of Illinois.
“The payment of kickbacks or bribes in exchange for the referral of Medicare or Medicaid patients, regardless of the form in which they are paid, is a crime,” said Lamont Pugh III, Special Agent-in-Charge of the Chicago Region of HHS-OIG. “The Office of Inspector General will continue to work closely with our law enforcement partners to aggressively investigate alleged illegal patient referral schemes and hold accountable those who seek to exploit vulnerable patients and the Medicare and Medicaid programs.”
“Today’s arrests demonstrate our commitment to enforcing the laws intended to prevent abuses of the Medicare and Medicaid programs and to preserve the ability of those programs to provide appropriate medical services to the elderly and the needy,” said Cory B. Nelson, Special Agent-in-Charge of the Chicago Office of the Federal Bureau of investigation.
The defendants were charged in a complaint that was filed yesterday and unsealed today after the arrests. All six defendants were scheduled to appear beginning at 3 p.m. before U.S. Magistrate Judge Daniel Martin in Federal Court.
Kickback Conspiracy
A 90-page affidavit in support of the criminal complaint and search and seizure warrants states that former Sacred Heart Physician A began cooperating in the investigation in October 2011, and Administrator A and Administrator B began assisting in January 2013 and February 2012, respectively. Each of them made consensual recordings of meetings and telephone conversations with other executives, administrators, physicians and employees that are described in the affidavit.
According to the complaint – at Novak’s direction and with his approval and Payawal’s assistance – Sacred Heart implemented a scheme to pay kickbacks to physicians in return or referrals of Medicare and Medicaid patients. Novak and Payawal allegedly tried to conceal the scheme by masking payments as fictitious rental payments; paying the salaries of physicians’ employees; providing physicians ghost contracts for duties without any real responsibilities; creating alternative billing arrangements; and purporting to pay physicians to supervise and teach non-existent medical students.
In a conversation that Administrator A recorded on Feb. 28, 2013, Novak and Payawal allegedly identified Drs. Moshiri, Maitra and May as physicians receiving regular kickback payments who Administrator A should pay.
Between January 2010 and February 2013, May allegedly received $74,000 in the form of 37 checks, for $2,000 each, disguised as “rental payments”; Moshiri, a podiatrist, allegedly received $86,000 in 38 checks pursuant to a purported contract to teach podiatry students; and Maitra allegedly received $68,000 in 34 checks pursuant to a purported teaching contract – and the $228,000 total in alleged kickbacks were all in exchange for their referral of patients to Sacred Heart, the charges allege.
In a recorded conversation last month, Maitra allegedly explained to Administrator A that he used to make Novak “so much money” performing almost daily penile implant procedures on patients, but that he no longer performed as many of those procedures because Medicare had decreased its rates of reimbursement for the procedure. Maitra did not comment on whether the patient need for the procedure had somehow changed, according to the affidavit.
Regarding Dr. Kuchipudi, Administrator A told agents that he was one of Sacred Heart’s most prolific patient referral sources and, according to Physician A, was known within the hospital as the “king of nursing homes.” According to Administrator A, Sacred Heart paid Kuchipudi for Medicare patient referrals in two ways: first, by paying most of the salaries of a physician’s assistant and a registered nurse who were effectively employed by Kuchipudi, and second, by paying Physician B for treating Kuchipudi’s patients at Sacred Heart, despite the fact that Kuchipudi, and not the hospital, billed insurers for the services Physician B provided to those patients. These arrangements allegedly benefited Kuchipudi as a result of the hospital absorbing employee salary costs that Kuchipudi would normally have to pay himself.
Emergency Room Admissions
Although not charged, the affidavit supporting the search warrant states that the investigation extends to allegations of unnecessary emergency room admissions. Administrator A told agents that Novak ignored numerous complaints that physicians admit patients who do not require hospitalization, and that certain physicians have subjected patients to unnecessary medial testing and procedures in an attempt to justify the patients’ admissions and to increase billing.
Insiders have told agents that Sacred Heart’s executives established a system to admit nursing home patients, irrespective of any medical necessity, by directing referring physicians to use ambulance companies with which Sacred Heart has had “a relationship.” By designating such patients as “direct admission,” Sacred Heart physicians are able to transfer their patients by ambulance from nursing homes, regardless of the proximity to the hospital. Instead of directly admitting these nursing home patients, however, Sacred Heart processes them through its emergency room, billing Medicare for emergency care, which is usually not medically necessary, according to Administrator A. Physician A told investigators that, in his experience, half of the patients presented to Sacred Heart’s ER already had a relationship with one of the hospital’s attending physicians and that the majority of those patients were admitted to the hospital from the emergency room.
Tracheotomy Procedures
The investigation is also probing claims that Sacred Heart Physician D, a pulmonologist, allegedly performs a high number of unnecessary intubations and prolongs them by directing heavy sedation of his patients, often resulting in tracheotomies being performed by Sacred Heart surgeons that may not have been medically necessary. Administrator A told agents that during a lunch with Novak and Payawal in December 2012, they both explained that tracheotomy cases provide substantial insurance reimbursement income for the hospital. On March 1, 2013, Administrator A recorded Novak stating that tracheotomies are Sacred Heart’s “biggest money maker” and the hospital can make $160,000 for a tracheotomy if the patient stays 27 days. On March 7, 2013, the Intensive Care Unit case manager told Administrator A that she must often “stretch” a tracheotomy patient’s stay to 28 days to maximize Medicare reimbursements “to make Novak happy.”
According to the affidavit, Sacred Heart allegedly conceals $7,000 monthly payments for respiratory patient referrals by paying that amount to a healthcare management company that has an employee who works at one of the nursing homes where Kuchipudi sees patients. The consulting firm employee works with Kuchipudi, nursing homes, and Sacred Heart to facilitate the admission of respiratory patients to Sacred Heart, Administrator A told investigators.
On March 4, 2013, investigators from CMS and the State of Illinois arrived at Sacred Heart to conduct an investigation of the hospital’s intubations and tracheotomies, and quality assurance and performance improvement protocols. On March 6, Administrator A recorded Physician D acknowledging that Sacred Heart lacked policies for various aspects of intubations and tracheotomies and that he had given some practice guidelines and procedures obtained from other hospitals to the surveyors in response to their request for Sacred Heart’s policies. At the same time, the ICU nurse manager told Administrator A that she had reviewed eight tracheotomy patient files in connection with the CMS investigation. Physician D was the pulmonologist for all the patients and had performed all but one of the tracheotomies. The nurse manager said that there was no documentation in the patient files explaining the decision to intubate the patients or any efforts to wean them from the ventilators. The following day Administrator A reported the findings to Novak and others and regarding the lack of documentation, and Novak replied with an expletive, according to the affidavit.
On April 8, Physician D told Administrator A in a recorded conversation that Novak had asked him to provide two more tracheotomy cases for the hospital soon before the CMS surveyors might return.
Novak’s Business Interests
According to the affidavit, Novak has direct or indirect ownership interest in various related entities, including Superior Home Health, LLC, a home healthcare company; the Golden L.I.G.H.T. clinics, which are family practice / internal medicine clinics operated as divisions as Sacred Heart; the Chen Medical center; the Garfield Kidney Center, LLC, an outpatient dialysis center; and the Bentley Insurance Group, a medical malpractice insurance company. Novak also owns various real estate and corporate management holding companies, and prior to June 2012, he operated the Chicago R.E.A.C.H Foundation, a purported non-profit, senior citizen program financed by the State of Illinois.
In a series of recorded conversations over the last two months, Payawal told Administrator A that a substantial part of Sacred Heart’s revenue comes from Medicare and Medicaid reimbursements, and explained various ways in which revenue generated from the hospital is transferred to and among Novak’s other corporate interests.
Conspiracy to violate the federal anti-kickback statute carries a maximum penalty of five years in prison and a $250,000 fine and restitution is mandatory. If convicted, the Court must impose a reasonable sentence under federal statutes and the advisory United States Sentencing Guidelines.
The government is being represented by Assistant U.S. Attorneys Joel Hammerman, Terra Reynolds and Ryan Hedges.
The public is reminded that a complaint is not evidence of guilt. The defendants are presumed innocent and are entitled to a fair trial at which the government has the burden of proving guilt beyond a reasonable doubt.
The case falls under the umbrella of the Medicare Fraud Strike Force, which expanded operations to Chicago in February 2011, and is part of the Health Care Fraud Prevention & Enforcement Action Team (HEAT), a joint initiative announced in May 2009 between the Justice Department and HHS to focus their efforts to prevent and deter fraud and enforce current anti-fraud laws around the country. More than five dozen defendants have been charged in health care fraud cases since the strike force began operating in Chicago.
To report health care fraud to learn more about the Health Care Fraud Prevention & Enforcement Action Team (HEAT), go to: stopmedicarefraud.gov.



Contact: Randall Samborn, Assistant US Attorney, Public Information Officer
Direct: (312) 353-5318, Cell: (312) 613-6700
Thank You US DOJ

HT to Ron Shrinkman at Fierce Health Finance

Tuesday, April 17, 2012

DOJ Wants J&J Incoming CEO Gorsky RE: Omnicare Kickback Allegations

FiercePharma has;

April 16, 2012 | By Ryan McBride

Alex Gorsky's name has surfaced in the U.S. government's Risperdal marketing lawsuit just weeks before he is supposed to step into the role of CEO at the healthcare giant Johnson & Johnson ($JNJ). The Department of Justice wants Gorsky to answer questions in its civil suit against J&J, and the company has been stymieing the effort in a struggle to keep its next chief executive out of the matter.

This is the latest chapter in the ongoing saga involving alleged kickbacks to boost use of J&J's antipsychotic Risperdal in elderly people.

Justice officials claim that Gorsky, a J&J vice chairman who served in senior roles at the company during the years in question in their suit, might have some important info for their case. In a letter to Justice, J&J called the government's request to question Gorsky a "fishing expedition" and said it wouldn't make its CEO-to-be available to federal lawyers, Bloomberg reported.

The government's request to talk to Gorsky follows its civil lawsuit against J&J for shelling out millions of dollars in alleged kickbacks to Omnicare ($OCR) to get the pharmacy services provider to push for use of J&J drugs such as Risperdal with its nursing home customers, The Wall Street Journal reported. New Brunswick, NJ-based J&J has maintained its innocence in the case. Omnicare forked over $98 million to resolve its part in the kickback controversy, doing so without admitting guilt.

What does Gorsky know? The way Justice officials figure, he was in leadership positions at J&J and the company's Janssen unit, which sells Risperdal, at the same time alleged marketing misdeeds were committed during the late 1990s and 2000s. And he had a role in marketing activities at the company, according to the WSJ piece.

"Mr. Gorsky did have personal involvement in some of the transactions at issue, and likely has knowledge of others--and so the United States should be permitted to depose Mr. Gorsky," Justice wrote in its request to U.S. District Judge Richard Stearns, as quoted by the WSJ.

- get more in the WSJ article
- and
Bloomberg's report

Related Articles:
An Etch-a-Sketch picture of J&J CEO-to-be Alex Gorsky
J&J's $1.2B Risperdal fine 'ups the ante' for other cases
Feds reportedly demand $1.8B in Risperdal marketing probe


Thank You Fierce Pharma and Mr McBride


And, you should read the 1st up April 13th report from Pharmalot,


Because if you want a pdf of the actual Lawsuit, Pharmalot has it.

Also see Forbes for Ms Erika Kelton's: