Seton Hall University School of Law Launches European Healthcare Compliance Certification Programme in Paris
Filed under: Compliance, Health Law, Seton Hall Law
Press Release: Seton Hall University School of Law Launches European Healthcare Compliance Certification Programme in Paris
Co-presented by:
Seton Hall School of Law and Sciences Po
June 21 - 25, 2010- Sciences Po, Paris, France
- www.sciences-po.fr/spf/healthcare
PRESS RELEASE
Phone: 973.642-8863
E-mail: simone.handler-hutchinson@shu.edu
Website: law.shu.edu/Paris OR www.sciences-po.fr/spf/healthcare
The Healthcare Compliance Certification Programme, co-organized by Sciences Po Executive Education (Paris, France) and Seton Hall University School of Law (Newark, N.J) to be held from June 21-25, 2010 on the Paris campus of Sciences Po today announced its 2010 topics and faculty.
FEATURED FACULTY:
CURRENT & FORMER REGULATORY & ENFORCEMENT OFFICIALS:
Paul McNulty, Partner, Baker & McKenzie, LLP (DC) Former U.S. Deputy Attorney General
Kirk Ogrosky, Partner, Arnold & Porter LLP (DC), Former Deputy Chief, Health Care Fraud, Criminal Division, U.S. Dept. of Justice
INTERNATIONAL ORGANIZATIONS
Alex Conte, Senior Legal Analyst, Anti-Corruption Division, OECD
Dr. Guitelle Baghdadi-Sabeti, Team Leader, Good Governance for Medicines, World Health Organization
Marie-Claire Pickaert, Deputy Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA)
COMPANY COMPLIANCE PROFESSIONALS:
Dirk Brinckman, Assistant General Counsel, Johnson & Johnson (Brussels)
Roeland Van Aelst, Vice President, EMEA & Canada, Office of Health Care Compliance & Privacy, Johnson & Johnson
KEYNOTE & ACADEMIC SPEAKERS:
Paul Benkimoun, Healthcare Journalist, Le Monde
Claude Le Pen, Professor, Université Paris-Dauphine
Kathleen Boozang, Professor of Law, Seton Hall Law School (Newark, NJ)
LEADING LEGAL AND COMPLIANCE COUNSEL AND ADVISORS:
Peter W.L. Bogaert, Managing Partner, Covington & Burling (Brussels)
John Rupp, Partner, Covington & Burling LLP (London)
Karolos Seeger, Partner, Debevoise & Plimpton LLP (London)
Susie Smith, Bevan Brittan LLP (UK)
Ted Acosta, Leader, Life Sciences & Corporate Compliance Fraud Investigation & Dispute Services, Ernst & Young LLP
Jill Deal, Partner, Venable LLP (DC)
Kristof Van Quathem, Data Protection Advisor, Covington & Burling LLP (Brussels)
Carolyn Lindsey, Director of Member Services, TRACE International
Owen Bevan, Director, Legal & Compliance Practice, Corporate Executive Board
PROGRAMME CURRICULUM:
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Surety Bond Requirements for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)
By Rachel Jones
Prosthetic Leg, 1575
The final rule implementing surety bond requirements for DMEPOS became effective March 3, 2009. The regulation implemented the surety bond requirements for DMEPOS set forth in section 4312(a) and (c) of the Balanced Budget Act of 1997 (BBA).  The Centers for Medicare & Medicaid Services (CMS) proposed a rule on January 20, 1998 (63 FR 2926) reflecting the BBA’s surety bond requirements and solicited comments.  Comments were solicited for advisability with respect to Section 4312(c) of the BBA, which further allowed CMS to require a surety bond from some or all providers or suppliers who furnish items or services under Medicare Part A or Part B and not solely Durable and Medical Equipment (DME) suppliers.  A substantial amount of comments were received and in the final published rule on October 11, 2000 (65 FR 60366), CMS decided to delay the final rule with respect to surety bond requirements for suppliers of DMEPOS in order to further study the issue. However, in 2003 Congress enacted section 902 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173) (MMA) which prohibits the Secretary of Department of Health and Human Services from finalizing a proposed rule related to Title 18 that was published more than 3 years earlier except under exceptional circumstances.  In response to this CMS proposed a rule on August 1, 2007 (72 FR 42001) to implement the statutory surety bond requirements set forth in the BBA. CMS received approximately 200 comments that were considered before they published the final rule on January 2, 2009. (FR 30802)
Surety bonds are a financial guarantee whereby a first party (obligee) contracts with a second party (principal) to perform duties in a contract that will benefit a third party (surety). The first party guarantees that the second party will fulfill its obligation(s) under the contract and in the event that the obligations are not met, the first party will recover its losses via the bond.  CMS has imposed the rule in order to deter fraud and abuse by Medicare suppliers of DMEPOS.  CMS believes a surety bond requirement will (1) limit the Medicare program risk to fraudulent DMEPOS suppliers; (2) enhance the Medicare enrollment process to help ensure that only legitimate DMEPOS suppliers are enrolled or are allowed to remain enrolled in the Medicare program; (3) ensure that the Medicare program recoups erroneous payments that result from fraudulent or abusive billing practices by allowing CMS or its designated contractor to seek payments from a surety up to the penal sum; and (4) help ensure that Medicare beneficiaries receive products and services that are considered reasonable and necessary from legitimate DMEPOS suppliers. CMS has also instituted other measures– including requiring accreditation for DMEPOS suppliers to deter fraud.
Who is affected by the surety bond requirements?
The regulation affects many healthcare providers; generally any DMEPOS supplier that is registered with the National Supplier Clearinghouse (NSC) may be subjected to the surety bond requirement. Every DMEPOS supplier to Medicare patients must register with the NSC. There are several exempt DMEPOS suppliers under the regulation:
I.     Government-owned suppliers,
II.      State-licensed orthotic and prosthetic personnel in private practice making custom made orthotics and prosthetics if the business is solely-owned and operated by said personnel and is billing only for orthotic and prosthetics, and supplies,
III.     Physicians and non-physician practitioners if the DMEPOS items are furnished only to his or her patients as part of his or her professional service, and
IV.     Physical and occupational therapists if: (1) the business is solely-owned and operated by the therapist, and (2) if the DMEPOS items are furnished only to his or her patients as part of his or her professional service.
The economic impact on non-exempt healthcare providers is significant since the regulation requires a minimum of $50,000 surety bond. This bond amount is required for each National Provider Identifier (NPI). Since DMPEOS suppliers must obtain an NPI by practice location, this amount can become quite significant for a supplier with multiple locations. The estimated cost to DMPEOS suppliers is approximately $1200 per $50,000 surety bond, depending on the company’s financial stability. The regulation also permits an additional $50,000 surety bond for high risk DMPEOS. For example, if a DMPEOS supplier has an adverse legal action within the last ten years preceding enrollment, revalidation, or re-enrollment then an additional $50,000 surety bond is required per adverse legal action. An adverse legal action includes: Medicare imposed revocation of any Medicare billing number, suspension of a license to provide health care by any State licensing authority, revocation or suspension of accreditation, a conviction of a Federal or State felony offense or an exclusion or debarment from participation in a Federal or State health care program.
CMS believes that the surety bond will deter fraudulent activity because a fraudulent DMEPOS supplier will not likely post a surety bond.   However, it is more likely the basis for this new requirement is to more easily allow CMS to recoup lost funds due to fraudulent activities. In addition, the bond requirement allows CMS to track and reprimand those DMEPOS suppliers that have continuously violated the law and stayed in the Medicare
Taking the Fraud Out of Medicare Expansion
Filed under: Fraud & Abuse, Medicare & Medicaid, Obama Administration
Decamps (1837)
One of the ways the Obama administration hopes to pay for health care reform is through policing Medicare fraud. It is estimated that the Centers for Medicaid and Medicare Services (CMS) spends $60 billion a year on fraudulent claims. According to Senator Grassley of Iowa, the federal agency received warnings of fraud by watchdog organizations, but did not respond to most of them; these warnings fell upon the CMS’s shoulders under the Bush Administration.
A report by the Department of Health and Human Services finds that much of the fraud in the Medicare Prescription Benefit program could have been avoided through better management of the companies that were hired by the federal government in 2006 to investigate and monitor the fraud.  Grassley notes that the companies, called Medicare drug integrity contractors or Medics, were essentially a waste of money because they were never given the proper information to perform the audits. The New York Times reports that the Bush Administration did not allow for the audits by Medics to proceed until its final few months in office.
Under the current model, scams to get Medicare reimbursement for non-existent services are easier than one might think. Just this past July, a couple who owned a medical business was indicted for submitting false reimbursement bills to the CMS for power wheelchairs that they claimed had been lost or destroyed during Hurricane Katrina. Other scams include medical suppliers billing Medicare for equipment that was never given to patients, creation of fake medical supply companies, and acceptance of illegal kickbacks for referring Medicare patients to unneeded services.
Solutions to fraud, however, are not as clear-cut as one might wish. For example, there is a worry that over-policing the CMS will lead to valid claims being denied at greater rates. Also, enforcement and punishment are issues. Some health care companies have been able to escape criminal prosecution by paying restitution amounts for the fraudulent claims. Finding restitution to be an insufficient deterrent to would-be fraudsters,  Senator Arlen Specter of Pennsylvania wants to see scammers put behind bars. But there is also something to be said for the realization that the “Arthur Anderson solution” is really no solution at all.
Another interesting aspect to consider here is that the CMS finds that provisions of the House bill intended to reduce Medicare fraud will not save all that much money. In spite of this (or perhaps because of it) many of our leaders have demanded that some action be taken to reduce Medicare fraud– even Sarah Palin says fraud is an issue. One hopes that the Obama administration will learn from its predecessor’s mistakes (if in fact they be such) when it comes to creating watchdogs such as Medics, but then muzzling and not feeding them.
Turning Up the Heat on Fraud and Abuse–Part of the Solution to Health Reform?
Giotto di Bondone, The Seven Vices: Envy (1266-1337)
[Ed. note: As noted in the post above, we are very pleased to welcome the Executive Director of the Center for Health & Pharmaceutical Law & Policy, Tracy E. Miller, J.D., to Health Reform Watch today.]
As the search for new sources to fund health care reform intensifies, it seems more certain that increased enforcement of fraud and abuse will be part of the equation.  Both the House and Senate have incorporated increased enforcement as part of health care reform legislation. The health care reform bill released by House Democrats on July 14, 2009, included an additional $100 million to combat fraud and abuse as well as increased mandates for regulatory oversight and provider compliance programs.  The reform bill adopted by the Senate Health, Education, Labor and Pensions Committee on July 15 also embraced new enforcement measures, creating senior level positions at HHS and DOJ to coordinate oversight activities. The bills follow on the heels of an announcement in May by the Obama Administration that it had created an interagency task force to coordinate fraud and abuse enforcement.
These new enforcement initiatives and proposals add to an already burgeoning increase in enforcement initiatives at the state and national levels, raising the question of whether additional programs can actually have a substantial impact beyond those already underway to combat fraud and abuse in the  health care sector.
The Deficit Reduction Act (DRA) of 2005 provided states with an incentive to enact False Claims Act statutes similar to the Federal False Claims Act, allowing states to retain 10% of any funds collected under such acts. The impact of the laws adopted in the wake of the DRA is unfolding now in many states and will no doubt lead to a significant jump in qui tam actions. Â After a hiatus caused by litigation challenging the program, CMS has continued to roll out the Recovery Audit Contractors Program (RAC) which retains contractors paid on a contingency basis to identify fraud and abuse in the Medicare program. Â With funding and a mandate from Congress, CMS also established the Medicaid Integrity Program. The program authorizes CMS contractors to use data mining and analysis techniques that combine health care quality indicators, billing practices, and Medicaid reimbursement rules to predict aberrant billing practices in order to identify providers for audit.
At the state level, Attorneys General as well as state Medicaid fraud offices are also turning to data mining and analysis, enhancing their capacity to identify fraud and target their investigations.[1] State Attorneys General have increased their cooperation nationally, heightening the effectiveness of investigations and actions against corporations that conduct business in multiple states.
Whether increased enforcement funds and cooperation among federal agencies will actually produce significant dollars for health reform remains to be seen. But without question, the combined effect of mounting federal and state enforcement efforts has substantially increased the stakes for health care providers in undertaking a proactive approach to compliance. Â Indeed, growing use by federal and state enforcement agencies on data mining and analysis challenges providers to determine how they can use their own internal data to identify compliance problems and address them in advance of government action.[2]
[1] Using Data to Advance Compliance: Emerging Practices in Industry and Government
June 4, 2008
Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy program focused on best practices by industry to use data for compliance, and government use of data mining and analysis to enhance oversight. Lori Queisser, Senior Vice President, Global Compliance & Business Practices of Schering Plough and Eileen Erdos, Principal of Ernst and Young, provided insight about how industry can use data to inform internal compliance programs. James Sheehan, New York State Medicaid Inspector General and John Krayniak, Assistant Attorney General, New Jersey Medicaid Fraud Control Unit, spoke about government initiatives to use data to target and pursue enforcement. The program, by invitation only, afforded industry counsel the opportunity to have a dialogue with the region’s two leading state prosecutors. The point being, that the success of enforcement initiatives is not only measured in prosecutions, but also in industry tailoring its behavior to be in compliance.
[2] Using Data to Advance Compliance
On March 16, 2009, the Center for Health and Pharmaceutical Law & Policy co-sponsored a program with KPMG on Using Data to Advance Compliance. The program, held in New York City for an audience comprised primarily of hospital leaders in compliance, finance, and in-house legal services, featured a presentation by James Sheehan, Medicaid Inspector General for New York State, who discussed how the Office of Medicaid Inspector General is using data to target and pursue investigations. Experts from KPMG presented practical, concrete strategies for how facilities can use data to advance internal compliance efforts. Ed Kornreich, a partner at Proskauer Rose, examined the implications of data mining for Board fiduciary duties.
Synthes Legal Troubles –Again
Filed under: Drugs & Medical Devices, FDA, Fraud & Abuse
[Today's Post is by Maansi K. Raswant, a Seton Hall Law student pursuing the Health Law concentration. She is a research assistant to the Center for Health & Pharmaceutical Law & Policy and an intern at the NYC Health and Hospitals Corporation.]
Recently, the Synthes corporation has been garnering a lot of attention, but for all the wrong reasons. A June 17th indictment comes a little over a month after the New Jersey Attorney General announced that the medical device maker had entered into a settlement agreement for failing to disclose financial conflicts of interests held by physicians conducting clinical trials for its products (see prior post, “Clinical Research: When the Compensation Begs the Answer“). Filed by the United States Attorney for the Eastern District of Pennsylvania, the recent 52-count indictment alleges that from May 2002 to Fall 2004, the Swiss company Norian, and its parent company Synthes, (both based in West Chester, Pennsylvania) conspired to conduct unauthorized clinical trials of Norian XR and Norian SRS, bone cement products used in surgery to treat vertebral compression fractures of the spine. Not only did the trials lack FDA authorization, but the FDA had specifically warned Synthes against using Norian XR for spinal surgery due to safety concerns.
The indictment explains that preliminary studies using human blood in test tubes found that the bone cement products chemically reacted with the blood to create blood clots. In further studies of the prod in a pig, the clots became wedged in the lungs. Despite this knowledge, Synthes continued to market the Norian products for use in spinal surgery, and did not stop doing so until after three patients had died on the operating table. According to the indictment, rather than recall the products following the patient deaths, the company engaged in a cover up by lying to FDA officers during an official inspection in May and June 2004.
The two recent legal actions against Synthes break new ground, and represent significant inroads by prosecutors in the arena of clinical research. Among other remedies, the settlement with the State of New Jersey required Synthes to disclose all relevant financial interests of its investigators on a public website, and barred the company from compensating investigators with stock, a practice the Attorney General called widespread in the industry. The latest indictment contains not just the usual charges against the corporations, but also criminal charges against four corporate executives charged with shipment of unauthorized devices. If found guilty, each executive faces up to a year in prison.
Crackdown on Fraud and Abuse in Detroit, Miami Signals Health Care Reform as a Priority of the Obama Administration
Filed under: Fraud & Abuse, Medicare & Medicaid, Obama Administration
Photo by bixentro via Flickr
Federal agents arrested dozens of people in Miami and Detroit yesterday morning for allegedly submitting Medicare claims totaling $50 million for treatments that were unneeded and sometimes never provided, according to The Washington Post.
Later in the day, the Justice Department unsealed criminal indictments against 53 people in connection with the arrests. In Detroit, the indictments focus on costly HIV/AIDS infusion drugs as well as physical and occupational therapy treatments.
According to The Post,
Authorities filed criminal charges against patients, doctors, medical assistants and company owners who allegedly played complicit roles in the fraud schemes. Prosecutors are seeking forfeiture of the criminal proceeds and restitution to the Medicare program.
The action was announced at a news conference held by Attorney General Eric H. Holder Jr., Health and Human Services Director Kathleen Sebelius, and FBI Director Robert S. Mueller III.
We will strike back against those whose fraudulent schemes not only undermine a program upon which 45 million aged and disabled Americans depend, but which also contribute directly to rising health-care costs,
said Attorney General Holder.
Las Vegas Infectious Disease Specialists Accused of Fabricating Medicare Services
Photo by a.drian via Flickr
The Las Vegas Sun reports that the Nevada Medical Examiners Board is investigating into the falsification of medical records at HealthSouth Tenaya. Raye Kraft, wife of a patient at this hospital, began to notice “infectious disease specialists Dr. Dhiresh Joshi and his then-employee, Dr. Fadi El Salibi,” writing in Kraft’s husband’s medical charts that they were examining him when they were not. As her suspicion rose, Ms. Kraft took detailed notes of when the specialists charted activity on her husband, compared these notes with her insurance bill and her own notes of the times they actually examined him, and then sent these notes and comparisons along with a complaint to the Nevada Medical Examiners Board.
The Sun reports:
Her claim: that on an ongoing basis, Joshi and El Salibi were writing in the chart that they had examined her husband when they hadn’t, and then billing for it. One supposed exam was nothing more than the doctor’s friendly wave from the door, she said.
Ms. Kraft’s was not the only person suspicious. The article notes that another patient “had complained a year earlier to the medical board of similar experiences.” Additionally, nurses at MountainView Hospital Medical Center also filed complaints “about El Salibi’s fly-by visits.”
In addition, the number of patients Dr. Joshi has claimed to have examined in the course of a day has been deemed further cause for suspicion. According to the Sun, Elizabeth Neubauer, Dr. El Salibi’s former billing manager, “said that Joshi himself routinely billed for 70 patients a day. Other infectious diseases doctors say that’s double the number they could reasonably see in a long day of hospital rounds.”
The Sun also reports:
Indeed, a 2004 Medicare audit showed that in a single day, Joshi billed for an impossibly high number of patients - 104, according to Neubauer’s recollection. Joshi said it was 81 Medicare patients, and 20 of them were seen by medical residents under his supervision.
One might have thought that the audit would have served as a red flag for further examination for fraud and abuse at that time. An “impossibly high number of patients” is, after all, impossible– and therefore seemingly either the result of either inadvertence or knowing falsehood. If a pattern of such “impossible” billing emerges, “inadvertence” begins to seem less likely– especially when coupled with independent allegations of “overbilling.”
The articles reports that “[a]llegations about doctors fraudulently billing Medicare and insurance companies are whispered throughout the Las Vegas medical community . . . .” One might hope that the numerical evidence derived from audits in cases such as this would do more than whisper– and would occasion heightened scrutiny.
Home Health Area Especially Vulnerable To Medicare Fraud And Abuse
Photo by consumerfriendly via Flickr
American Health Lawyers Association reports that the increased amount of federal spending on home health benefits has led to the rise of fraud and abuse issues. AHLA reports that federal “spending on home health grew approximately 44% from 2002 through 2006 ….”
AHLA states:
Gaps in the Centers for Medicare and Medicaid Services’ (CMS’) administration of the $12.9 billion Medicare home health benefit have left the program vulnerable to improper payments, including payments for claims resulting from fraudulent and abusive practices, the Government Accountability Office (GAO) found in a recent report.
The opportunities for fraud and abuse issues concerning home health care are manifold. AHLA states that the “common types of upcoding and billing for unnecessary care in home health were: billing for outlier cases when that level of care was not required, billing for beneficiaries who were not homebound, and billing for therapy visits that may have been medically unnecessary. ”
The Department of Justice defines upcoding as “the practice of improperly assigning a diagnosis code to a patient discharge that is not supported by the medical record for the purpose of obtaining a higher level of reimbursement for that hospital discharge than the hospital would otherwise receive.”
AHLA also reports that Home Health Agencies (HHAs) “are not routinely subject to revalidation and that CMS generally does not include physicians, who are in a position to detect certain types of improper billing, in the agency’s efforts to detect improper payments.”
AHLA reports that CMS is considering adopting two of the four actions recommended by GAO:
CMS stated that it would consider two of GAO’s four recommendations–to amend regulations to expand the types of improper billing practices that are grounds for revocation of billing privileges and to provide physicians who certify or recertify plans of care with a statement of services received by beneficiaries. The agency “neither agreed nor disagreed with our other two recommendations,” GAO explained.
AHLA reports that the four recommendations for CMS are:
- Assess the feasibility of verifying the criminal history of all key officials named on an HHA enrollment application.
- Provide physicians whose identification number was used to certify or recertify a plan of care with a statement of services the HHA provided to that beneficiary based on the physician’s certification.
- Direct CMS contractors to conduct post-payment medical reviews on claims submitted by HHAs with high rates of improper billing identified through prepayment review.
- Amend current regulations to expand the types of improper billing practices that are grounds for revocation of billing privileges.
Family-Run Medical Equipment And Billing Companies Enterprise Lead To Prison Time
photo by gillmccoll via Flickr
The Miami Herald reports that Laura and David Hernandez, as well as other family members, were sentenced by U.S. District Judge Adalberto Jordan for running a fraudulent Medicare operation.
The Herald states:
Over the past decade, the family-run enterprise of medical equipment and billing companies submitted more than $17 million in false claims to Medicare, they admitted in court.
Their total take: about $6 million.
The family-run enterprise started as a sole medical equipment company and later transformed into “a string of equipment businesses in Miami-Dade.” David Hernandez, a Cuban immigrant who is said to have completed formal schooling up to only the ninth grade, was the mastermind of the conspiracy:
David Hernandez, in the lead role, recruited four people to register as the official owners of four equipment-supply companies to conceal his participation in the scam, according to the court statement. Those ”nominee” owners, members of another family, were charged in a separate Medicare fraud indictment.
The DOJ Sets Its Sights On Forest Laboratories
Photo by neur0nz via Flickr
Forbes reports in its article, “Forest says 11 states will join fraud lawsuit,” and the New York Times reports in its article, “Drug Maker Is Accused of Fraud,” that a civil claim was filed against Forest Laboratories Inc. under the False Claims Act. The claim relates to the advertisement of the “off-label” use of certain drugs.
Forbes reports:
The Justice Department said Forest promoted Lexapro and Celexa for use by children even though it is not allowed to do so. While doctors are allowed to prescribe drugs for uses not listed on the labels, companies are not allowed to actively promote the drugs for that kind of “off-label” use.
This suit is similar to the qui tam actions against Scios. Both the cases against Scios and the suits against Forest Laboratories involve the off-label marketing of the unapproved uses of certain prescription drugs. And like the claims against Scios, it appears that the case against Forrest Laboratories began as a qui tam action.
The NY Times reports:
The filing follows a long-running federal investigation that began with complaints filed by two former company officials. Under the civil charges brought against Forest, the government is seeking to recover up to three times the amount of money spent by federal programs to pay for pediatric prescriptions of Celexa and Lexapro, but did not specify a figure.
This case is consistent with the DOJ’s heightened investigation of the pharmaceutical industry and shows the federal government’s reliance on qui tam actions. As the number of cases against pharmaceutical companies for the off-label advertising of the unapproved uses of drugs increases, the gap between the FDA approval of the use of drugs and the actions of pharmaceutical companies is becoming more apparent.
To some extent, the Civil False Claims Act is bridging this compliance gap by functioning as a mechanism to enforce FDA decisions on the uses of drugs. But perhaps a legitimate question to ask is whether this increasing reliance upon an “outsourcing” of regulatory compliance is the appropriate mechanism by which to fix this inefficiency. Or, might we consider, as recommended by the recent Center for Health & Pharmaceutical Law & Policy whitepaper, being that “estimates suggest that as many as 40% of all prescriptions are for off-label uses,” that we give the “FDA the authority to mandate scientific studies for off-label medications and devices that have high sales volumes or large profits but lack needed evidence of efficacy or safety?”
As the Center stated, “this would protect the interests of patients and advance sound choices about the risks, benefits, and economic value of off-label uses.”
DOJ Plans To Intervene In Two Qui Tam Actions Against Scios
Photo by Feliz63 via Flickr
Kaiser Family Foundation reports the intervention of two qui tam civil False Claims Act actions. The qui tam actions involve the off-label marketing of medication unapproved for certain usages. The medication in question is Natrecor, a heart failure medication. There are two qui tam actions against Scios, a subsidiary of Johnson and Johnson. Kaiser states:
The Department of Justice on Thursday announced plans to join two whistleblower lawsuits filed against Johnson & Johnson subsidiary Scios over allegations that the company illegally marketed the heart failure medication Natrecor for unapproved uses and defrauded Medicare and other federal health care programs, the San Francisco Chronicle reports. FDA in 2001 approved Natrecor for use in hospital patients who experienced shortness of breath caused by acute congestive heart failure (Egelko, San Francisco Chronicle, 2/20).
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