{"id":16886,"date":"2015-10-29T14:59:38","date_gmt":"2015-10-29T21:59:38","guid":{"rendered":"https:\/\/cjnotebook.com\/?p=16886"},"modified":"2015-10-29T14:59:38","modified_gmt":"2015-10-29T21:59:38","slug":"drug-manufacturer-pays-125-million-for-giving-kickbacks-to-physicians-for-referrals","status":"publish","type":"post","link":"https:\/\/cjnotebook.com\/?p=16886","title":{"rendered":"Drug Manufacturer Pays $125 Million for Giving KickBacks to Physicians for Referrals"},"content":{"rendered":"

MASSACHUSETTS<\/h2>\n
\n

\"Health<\/a>Federal law states that it’s illegal to offer to to pay doctors so they can refer patients to pharmacies to get drugs for where payments are made in whole or part under a federal health care program, according to authorities.<\/p>\n

The U.S. Department of Justice said today that\u00a0Warner Chilcott U.S. Sales LLC,<\/strong> a subsidiary of pharmaceutical manufacturer Warner Chilcott PLC, violated this law and agreed to pay $125 million, officials said.<\/p>\n

Warner Chilcott agreed to plead guilty in Massachusetts to criminal charges that the company committed a felony violation by paying kickbacks to physicians throughout the U.S. to induce them to prescribe its drugs, manipulating prior authorizations to induce insurance companies to pay for prescriptions of Atelvia\u00ae that the insurers may not have otherwise paid for and making unsubstantiated marketing claims for the drug Actonel\u00ae.<\/p>\n

The case was brought to light after whistleblowers<\/strong> filed a lawsuit under the provisions of the False Claims Act,<\/strong> which allows\u00a0private individuals to sue on behalf of the government for false claims and to share in any recovery.<\/p>\n

The whistleblowers will get about $22.9 million from the federal government as their share of the civil recovery, according to officials.<\/p>\n

\u201cPlacing\u00a0financial gain above the legitimate needs of patients is deplorable,\u201d said Inspector General Daniel R. Levinson of the U.S. Department of Health and Human Services.<\/strong>\u00a0\u201cPaying kickbacks and even providing instructions on how to defraud Medicare are practices that will not be tolerated.\u201d<\/p><\/blockquote>\n

Warner Chilcott\u00a0agreed to plead guilty to a felony charge of health care fraud, federal prosecutors said.<\/span><\/p>\n

The plea agreement is part of a global settlement with the federal government in which Warner Chilcott has agreed to pay $125 million to resolve its criminal and civil liability arising from the company\u2019s illegal marketing of the drugs Actonel\u00ae, Asacol\u00ae, Atelvia\u00ae, Doryx\u00ae, Enablex\u00ae, Estrace\u00ae <\/strong>and Loestrin\u00ae.\u00a0<\/strong><\/span><\/p>\n

Before today\u2019s guilty plea by Warner Chilcott, several individuals also pleaded guilty or were charged in connection with the company\u2019s illegal activities.<\/p>\n

Earlier today, an indictment was unsealed in the District of Massachusetts charging former Warner Chilcott President W. Carl Reichel<\/strong>, 57, of Chester, New Jersey, with one count of conspiring to pay kickbacks to physicians.\u00a0 Reichel<\/strong> was arrested today in Boston and will make an initial appearance at 2:30 p.m. before U.S. District Court Magistrate Judge Jennifer C. Boal.<\/strong><\/p>\n

\u201cThe Justice Department is committed to protecting the integrity of physician prescribing decisions and ensuring that financial arrangements in the healthcare marketplace comply with the law,\u201d said Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department\u2019s Civil Division.\u00a0<\/strong> \u201cThe Department will continue to hold companies and responsible individuals accountable when they use improper incentives, like those alleged here, to promote their products.\u201d<\/p>\n

\u201cDoctors\u2019 medical judgment should be based on what is best for the patient, and not clouded by expensive meals and other pharmaceutical company kickbacks,\u201d said U.S. Attorney Carmen M. Ortiz for the District of Massachusetts.\u00a0<\/strong> \u201cPharmaceutical company executives and employees should not be involved with treatment decisions or submissions to a patient\u2019s insurance company.\u00a0 Today\u2019s enforcement actions demonstrate that the government will seek not only to hold companies accountable, but will identify and charge corporate officials responsible for the fraud.\u201d<\/p>\n

In a criminal information filed today, these are the allegations:<\/strong><\/p>\n

Between 2009 and 2013, Warner Chilcott, through its employees acting at the direction of members of the company\u2019s management team, \u00a0paid remuneration to physicians in order to induce those physicians to prescribe Warner Chilcott drugs.<\/p>\n

The information alleges that Warner Chilcott employees, at the direction of company management, provided payments, meals and other remuneration associated with so-called \u201cMedical Education Events,\u201d which included dinners, lunches and receptions.<\/p>\n

These events, which were often held at expensive restaurants, often contained minimal or no educational component and were instead used to pay prescribing physicians in an attempt to gain a \u201ccompetitive advantage\u201d over other companies.<\/p>\n

Warner Chilcott also enlisted high-prescribing physicians as \u201cspeakers\u201d for the company.\u00a0 In fact, the \u201cspeakers\u201d often did not actually speak about any clinical or scientific topics, and, instead, the payments were primarily intended to induce prescriptions.<\/p>\n

For instance, Warner Chilcott informed \u201cspeakers\u201d who were not prescribing at a high volume that they would not be paid for subsequent events unless their prescribing habits increased.<\/p>\n

In addition, the information alleges that from 2011 to 2013, Warner Chilcott employees knowingly and willfully submitted false, inaccurate, or misleading prior authorization requests and other coverage requests to federal health care programs for the osteoporosis medications Atelvia\u00ae and Actonel\u00ae.<\/p>\n

The false, inaccurate and misleading information was provided to certain insurance companies in order to overcome formulary restrictions that favored less expensive osteoporosis drugs.<\/p>\n

For instance, Warner Chilcott was aware that many insurers only paid for Atelvia\u00ae if a physician submitted an individualized request explaining why the patient could not be treated with less-expensive medications approved to treat the same conditions.<\/p>\n

As detailed in the information, Warner Chilcott sales representatives filled out numerous prior authorizations for Atelvia\u00ae, using \u201ccanned\u201d medical justifications which often were inconsistent with the patients\u2019 medical conditions.<\/p>\n

In some instances, according to the information, Warner Chilcott sales representatives submitted these prior authorizations directly to insurance companies, holding themselves out to be physicians.<\/p>\n

In other cases, sales representatives coached physicians and staff about which medical justifications would result in an approved prior authorization, whether or not the justification was true for a particular patient.<\/p>\n

Finally, the information alleges that Warner Chilcott employees were instructed by members of the company\u2019s management team to make unsubstantiated superiority claims when marketing the drug Actonel\u00ae.<\/p>\n

The management team instructed the sales representatives to tell physicians that Actonel\u00ae was superior to other bisphosphonates due to its supposedly unique \u201cmechanism of action.\u201d<\/p>\n

According to the information, Warner Chilcott managers also encouraged sales representatives to use props to visually support this false claim, including pouring water and syrup onto two sponges while telling physicians that Actonel, like water, penetrated and exited the bone more quickly than its competitors, represented by the syrup.<\/p>\n

Warner Chilcott management directed the sales representatives to make the superiority claim even though the claim was not supported by clinical evidence.<\/p>\n

Under the terms of the plea agreement, Warner Chilcott will pay a criminal fine of $22.94 million.<\/p>\n

Warner Chilcott also entered into a civil settlement agreement under which it agreed to pay $102.06 million to the federal government and the states to resolve claims arising from its conduct, which allegedly caused false claims to be submitted to government health care programs.<\/p>\n

The civil settlement resolved allegations that Warner Chilcott violated the federal Ant-Kickback Statute by paying illegal remuneration to prescribing physicians in connection with the so-called \u201cMedical Education Events\u201d and speaker programs and caused the submission of false prior authorization requests for Atelvia\u00ae and Actonel\u00ae.<\/p>\n

The federal share of the civil settlement is approximately $91.5 million, and the state Medicaid share of the civil settlement is approximately $10.6 million.<\/p>\n

Prior to today\u2019s guilty plea by Warner Chilcott and civil settlement, several individuals were either criminally charged or pleaded guilty to various offenses related to the company\u2019s alleged conduct.<\/p>\n

Two former district managers, Jeffrey Podolsky<\/strong>, 49, of East Meadow, New York, and Timothy Garcia,<\/strong> 35, of Los Gatos, California, previously pleaded guilty to various charges, including conspiracy to commit health care fraud and violations of the Health Insurance Portability and Accountability Act or HIPAA.<\/p>\n

A third former district manager, Landon Eckles,<\/strong> 30, of Huntersville, North Carolina, was criminally charged earlier this month for alleged HIPAA violations relating to the alleged prior authorization scheme.<\/p>\n

Last week a Springfield, Massachusetts physician, Rita Luthra, M.D<\/strong>., 64, of Longmeadow, Massachusetts, was charged with, among other things, allegedly accepting free meals and speaker fees from Warner Chilcott in return for prescribing its osteoporosis drugs.<\/p>\n

Download Carl Reichel Indictment<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

MASSACHUSETTS Federal law states that it’s illegal to offer to to pay doctors so they can refer patients to pharmacies to get drugs for where payments are made in whole or part…<\/p>\n","protected":false},"author":1,"featured_media":16893,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16,3],"tags":[1840,1359,1616],"class_list":["post-16886","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home-main-slider","category-u-s-department-of-justice","tag-department-of-health-and-human-services","tag-pharmaceutical-drugs","tag-whistleblower"],"yoast_head":"\nDrug Manufacturer Pays $125 Million for Giving KickBacks to Physicians for Referrals<\/title>\n<meta name=\"description\" content=\"MASSACHUSETTS Federal law states that it's illegal to offer to to pay doctors so they can refer patients to pharmacies to get drugs for where payments are\" \/>\n<meta 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