Menu Close

Category: Daily News

Device Maker Pays $36 Million in Misbranding Case

The Justice Department announced that medical device manufacturer Biocompatibles Inc., a subsidiary of BTG plc, pleaded guilty to misbranding its embolic device LC Bead and will pay more than $36 million to resolve criminal and civil liability arising out of its illegal conduct. LC Bead is used to treat liver cancer, among other diseases.

Under the terms of the plea agreement before the U.S. District Court for the District of Columbia, Biocompatibles pleaded guilty to a misdemeanor charge in connection with the company’s misbranding of LC Bead, in violation of the Food, Drug and Cosmetic Act. LC Bead was cleared by the U.S. Food and Drug Administration (FDA) as an embolization device that can be placed in blood vessels to block or reduce blood flow to certain types of tumors and arteriovenous malformations. LC Bead has never been cleared or approved by FDA as a drug-device combination product or for use as a drug-delivery device or “drug-eluting” bead.

As part of the criminal resolution, Biocompatibles will pay an $8.75 million criminal fine for the misbranding of LC Bead and a criminal forfeiture of $2.25 million. The FDA sought assurances in 2004 that Biocompatibles would not use FDA clearance for the device for embolization to market the device for drug delivery, according to a statement of offense to which the company agreed. Biocompatibles told the FDA that “under no circumstance” would the company use the embolization clearance to market the device for drug delivery.

However, two years later, Biocompatibles began marketing LC Bead for drug delivery through the company it hired to carry out its sales and distribution in the United States. According to the statement of offense, the distribution company told its sales representatives that LC Bead was “[a] drug-delivery device” and trained its sales representatives to “aggressively penetrate the chemoembolization market.”

Sales representatives subsequently told health care providers that the device increased the level of chemotherapy delivered to a liver tumor and resulted in “better tumor response rates,” despite the lack of FDA clearance or approval for that use and despite the absence at that time of statistically significant evidence to support such claims.

In addition, Biocompatibles will pay $25 million to resolve civil allegations under the False Claims Act that the company caused false claims to be submitted to government healthcare programs for procedures in which LC Bead was loaded with chemotherapy drugs and used as a drug-delivery device. When LC Bead was combined with prescription drugs for use as a drug-eluting bead, it constituted a new combination drug-device product that was not approved or cleared by the FDA and not covered by Medicare and other federal health care programs. The federal share of the civil settlement is approximately $23.6 million, and the state Medicaid share of the civil settlement is approximately $1.4 million.

The civil settlement with Biocompatibles resolves a lawsuit filed under the whistleblower provision of the False Claims Act, which permits private parties to file suit on behalf of the United States for false claims and share in a portion of the government’s recovery. The civil lawsuit was filed in the Western District of Texas and is captioned United States ex rel. Ryan Bliss v. Biocompatibles, Inc., et al. As part of this resolution, Bliss will receive approximately $5.1 million from the civil settlement.

WCAB Has Jurisdiction Over UR Penalties and Sanctions

Kathleen McKinney injured her neck and other body parts in 2014 while working as a driver for Enterprise Rent a Car. She filed four separate Petitions for Penalties and Sanctions under Labor Code sections 5813 and 5814. The gravamen of applicant’s theory is that when the RFAs were submitted, defendant had in its possession and control medical reports and records germane to each of the four RFAs and failed to provide the same to WellComp, its UR organization for consideration, causing the RFAs to be denied.

The defendant filed an Answer to each of the four Petitions for Penalties and Sanctions. In answer to Petition for Penalties and Sanctions # 1, defendant asserts that the RFA for Diclofenac ER 100 mg #60 was timely denied by Utilization Review (UR). In answer to Petition #2, defendant asserts that the RFA for two boxes of Salonpas was timely denied by UR;  and in answer to Petition #3, defendant contends that the RFA for trigger point injections was timely denied by UR;  and in answer to Petition #4, defendant also asserts that the RFA for Soma 350 mg. #60 was timely denied by UR. With respect to all four Petitions, it claimed that the WCAB lacks jurisdiction over applicant’s claim for penalties and sanctions.

Each of the four UR determinations identify the documentation reviewed by the physician. In each instance, the documentation reviewed was limited to the actual RFA and the treating physician’s contemporaneous progress report. There is no indication that additional records or documents, including the January 8, 2015 MRI results, were provided to the evaluating doctor.

The MRI findings that were not reviewed by UR note “chronic discogenic endplate changes at several levels,” and go on to describe central and neural forarninal narrowing at several levels, as well as “concentric uncovertebral hypertrophy (3 mm) with a superimposed left paracentral disc protrusion” at C4-C5.

The reason given for the non-certification was “[r]equest does not adequately document myofascial pain syndrome.” However the PTP progress reports dated June 4, 2015; June 25, 2015; and July 23, 2015 state that applicant has myofascial pain syndrome.

The WCJ found that defendant acted with bad faith in its handling of four separate Requests for Authorization of Treatment’ (RFA), making it liable for the imposition of sanctions under the provisions of Labor Code2 section 5813. The WCAB disagreed and reversed the sanctions in the panel decision of McKinney v Enterprise Rent a Car.

The significant issues in this case is jurisdiction of the WCAB to award penalties and sanctions despite the fact that UR was timely. In this regard the defendant argued that any dispute over the medical necessity of a particular treatment modality is within the exclusive purview of Independent Medical Review (IMR).

On the issue of jurisdiction, the WCAB disagreed with the defendant and ruled that Labor Code 5813 specifically authorizes the Appeals Board or a WCJ to order a party, a party’s attorney, or both, to pay any reasonable expenses incurred by another party as a result of bad faith actions or tactics that are frivolous or solely intended to cause unnecessary delay. Similarly, if the employer or its insurance carrier unreasonably delay or refuse to pay compensation and/or provide reasonable and necessary medical treatment to the industrially injured worker, section 5814 authorizes an increase in the delayed compensation payment up to prescribed monetary amounts.

The WCJ determined that defendant’s conduct in handling the four RFAs resulted from its willful failure to comply with its obligations under Administrative Director Rule 10109 because it had access to all of applicant’s medical records and diagnostic testing results but did not take the initiative to insure that complete records were provided to the UR doctor.

On this issue the WCAB panel disagreed with the WCJ. It noted that Administrative Director Rules 9785(g) and 9792.6.1(1)(2) require the RFA to include documentation substantiating the need for the requested treatment. The primary treating physician, and not a claims adjustor, is the one who knows what medical records substantiate the requested treatment. The four RFAs submitted by the PTP did include documentation, and presumably, the records and reports the PTP included with each RFA were those, in her expert medical opinion, that supported the recommended treatment.

Therefore, the WCAB cannot say that under these circumstances, defendant’s failure to take the initiative and submit applicant’s complete medical record to the UR doctor was a willful failure to comply with its regulatory and statutory obligations, or an indication of a bad faith tactic that is frivolous or solely intended to cause delay.

BUT the WCAB did not reach the issue of a defendant’s duty in ensuring that there is a complete record review by the UR doctor since, in this case, it was not shown that defendant abrogated its duty in bad faith or by frivolous action solely intended to cause unnecessary delay.

PA High Court to Rule on AMA Guides “Constitutionality”

At oral argument over the constitutionality of a Pennsylvania Workers’ Compensation Act provision that requires the incorporation of “the most recent edition” of the American Medical Association guidelines for evaluating claimants’ impairment ratings, several justices questioned the legislature’s decision to give a private group such wide latitude to shape state law.

In the case that may inspire constitutional attacks in other jurisdictions, Protz v. Workers’ Compensation Appeal Board (Derry Area School District) centers on the issue of whether Section 306(a.2) of the Pennsylvania act violates Article II, Section 1 of the Pennsylvania Constitution by delegating the legislature’s lawmaking authority to the AMA and allowing it to set the criteria for workers’ compensation adjudications.

In a deeply divided en banc ruling in Protz, the Commonwealth Court found that the requirement that impairment ratings be determined under the most recent edition of the AMA Guides to the Evaluation of Permanent Impairment left “unchecked discretion completely in the hands of a private entity.”

“The General Assembly has failed to prescribe any intelligible standards to guide the AMA’s determination regarding the methodology to be used in grading impairments,” Judge Dan Pellegrini wrote for the 4-3 majority. “Section 306(a.2) of the act is wholly devoid of any articulations of public policy governing the AMA in this regard and of adequate standards to guide and restrain the AMA’s exercise of this delegated determination by which physicians and [workers’ compensation judges] are bound.”

But the Commonwealth Court did remand the case to apply the fourth edition of the AMA Guides. Pellegrini said in his opinion that the fourth edition was the most recent version of the guides available when the Workers’ Compensation Act was enacted in 1996 – there have been two revisions since – and therefore the legislature adopted the methodology in that edition as its own.

During a Nov. 1 oral argument session before the state Supreme Court in Pittsburgh, counsel for both sides were peppered with questions from the justices about whether the legislature imbued the AMA with too much unchecked power.

“Doesn’t the legislature of Pennsylvania have the obligation to look each year at the AMA guidelines and decide whether to use that by reference or not, rather than to just defer to the AMA for the most recent explication on the issues?” Justice Debra Todd asked Thomas C. Baumann, counsel for plaintiff Mary Ann Protz.

Baumann agreed, but noted that revisions to the guidelines come out roughly every five to 10 years, so the burden on the state to review them would be relatively light.

Justice Christine L. Donohue asked Baumann whether his position was that the legislature could rely on a private group to develop standards as long as there was an “intermediate step” in which a governmental agency reviewed those standards and recommended whether to adopt them.

“The position is that the basic policy choices have to be made by the legislature and there have to be some guidelines for the exercise of the delegation,” Baumann said.

Baumann’s opposing counsel, David Dille, representing the Derry Area School District and its workers’ compensation carrier, argued that the legislature correctly left it to a group of medical experts to set the guidelines for medical evaluations in Pennsylvania.

Donohue, however, said the Workers’ Compensation Act “ties the hands” of medical experts who may disagree with the AMA guidelines.

“It does not, for example, allow for a physician to say, ‘I don’t like the AMA standards and you want to know why? Because it doesn’t take into account certain factors that go to the essence of determining an impairment or a disability,'” Donohue said. “It’s not as though it’s not possible to do this without delegating all these policy decisions to a private entity.”

Justice Max Baer, however, said that if a party disagrees with a doctor’s conclusion following an impairment rating examination, the party could hire an expert to offer a differing opinion and it would be up to a workers’ compensation judge to make the ultimate determination.

Dille said that’s what happened in Protz. “There were different opinions … and the judge made determinations with respect to the interpretation of the AMA impairment guides,” Dille said.

OIG Report Shows Home Health Care Industry “Ripe” With Fraud

The Personal Care Services program, which exceeded $14.5 billion in fiscal year 2014, is rife with financial scams, some of which threaten patient safety, according to a recent report from the Office of lnspector General at the Department of Health and Human Services.

The report exposes vulnerabilities in a system that more people will rely on as baby boomers age. Demand for personal care assistants is projected to grow by 26 percent over the next 10 years – an increase of roughly half a million workers – according to the U.S. Department of Labor.

“This type of industry is ripe for fraud,” warned Lynne Keilman-Cruz, a program manager at Alaska’s Department of Health and Social Services who has investigated widespread fraud. The risks increase because the care takes place out of view in people’s homes, and because neglected patients may not advocate for their own care.

The OIG report describes a range of rip-offs, some of which involve caretakers caught up in the nation’s opioid epidemic. In one Illinois case, a woman whose nursing license had been suspended for allegedly stealing drugs at work signed up as a caretaker. She billed Medicaid for $34,000 in caretaking services she didn’t provide – including charges made while she was on a Caribbean vacation. In Vermont, a caretaker on probation for drug possession split her paychecks with the patient’s wife – in exchange for stealing the patient’s prescription painkillers, while he lay in visible discomfort.

In other cases, Medicaid beneficiaries colluded in hoaxes, faking disability so they could hire unneeded help.

In some cases, elderly patients were neglected by their own children, who signed up for caretaker payments. In Idaho, a woman was hospitalized for severe dehydration and malnourishment after her son and caretaker, Paul J. Draine, neglected her. Investigators found the home they shared littered with drug paraphernalia. Draine pleaded guilty to fraud and abuse or neglect, and was sentenced to a sober home.

Investigators provided no count of how many cases of fraud and abuse involved relatives, but “it’s fairly common for family members to be the attendants, and it’s fairly common for those same family members to be the ones who are abusing, neglecting, or committing fraud,” said David Ceron, an OIG special agent based in Washington, DC. In California, three-quarters of Medicaid-funded personal assistants are relatives, though some states restrict hiring family members.

In California, a Kaiser Health News investigation last year revealed widespread problems, as well as a lack of training and oversight, in the state’s program, which is the largest in the U.S.

California’s frail elderly and disabled residents increasingly are receiving care in their own homes, an arrangement that saves the government money and offers many people a greater sense of comfort and autonomy than life in an institution. Yet caregivers are largely untrained and unsupervised, even when paid by the state, leaving thousands of residents at risk of possible abuse, neglect and poor treatment, a Kaiser Health News investigation found.

The move from nursing-home to in-home care is part of a massive shift across the nation, driven by cost-cutting and patient preference. In California, at least four times more elderly and disabled residents receive in-home care than live in nursing facilities – a rate that is only expected to rise as baby boomers age. California’s $7.3 billion IHSS program is the largest publicly funded caregiver program in the nation. The caseload has more than doubled since 2001 and now serves about 490,000 low-income clients throughout the state.

Kaiser Health News’ investigation into the IHSS program found that: training for caregivers is minimal and mostly optional. California doesn’t require training for everyone – even in CPR, first aid or preventing injuries. By design, IHSS is not a medical program and caregivers are supposed to confine themselves to tasks such as feeding, dressing or bathing. But some become ad hoc nursing aides, helping to dress wounds and manage medications. The state requires caregivers receive training and authorization from physicians in these cases, but only about one in nine caregivers receives it, officials say.

Counties are also supposed to report to the state “critical incidents” potential neglect, abuse or self-harm requiring immediate action. But reporting practices vary widely, yielding puzzling results. In fiscal year 2012-2013, for instance, not a single critical incident was reported among the 235,000 clients in Los Angeles, Orange and San Diego counties, the three largest in the state. That same year, smaller Sacramento County reported 1,688 incidents – accounting for most of the problems reported statewide.

“There is no evidence indicating that Sacramento County has a disproportionately higher number of critical incidents than other counties,” a Sacramento county spokeswoman said.

DOJ Expects Drugmaker Indictments by Year End

U.S. prosecutors are bearing down on generic pharmaceutical companies in a sweeping criminal investigation into suspected price collusion, a fresh challenge for an industry that’s already reeling from public outrage over the spiraling costs of some medicines.

According to the story in Bloomberg news, the antitrust investigation by the Justice Department, begun about two years ago, now spans more than a dozen companies and about two dozen drugs, according to people familiar with the matter. The grand jury probe is examining whether some executives agreed with one another to raise prices, and the first charges could emerge by the end of the year, they said.

Though individual companies have made various disclosures about the inquiry, they have identified only a handful of drugs under scrutiny, including a heart treatment and an antibiotic. Among the drugmakers to have received subpoenas are industry giants Mylan NV and Teva Pharmaceutical Industries Ltd. Other companies include Actavis, which Teva bought from Allergan Plc in August, Lannett Co., Impax Laboratories Inc., Covis Pharma Holdings Sarl, Sun Pharmaceutical Industries Ltd., Mayne Pharma Group Ltd., Endo International Plc’s subsidiary Par Pharmaceutical Holdings and Taro Pharmaceutical Industries Ltd.

All of the companies have said they are cooperating except Covis, which said last year it was unable to assess the outcome of the investigation.

“Teva is not aware of any facts that would give rise to an exposure to the company with respect to these subpoenas,” Teva spokeswoman Denise Bradley said in an e-mail. “To date, we know of no evidence that Mylan participated in price fixing,” Mylan spokeswoman Nina Devlin said in an e-mail. Mayne continues to cooperate with the Justice Department and believes the investigations will not have a material impact on its future earnings, the company said in a statement on Thursday.

Drug pricing has met harsh criticism from U.S. lawmakers in the past year. Former hedge fund manager Martin Shkreli set off the firestorm and drew the ire of Democratic presidential candidate Hillary Clinton after he acquired an old antiparasitic drug and raised the price to $750 a pill from $13.50. Valeant Pharmaceuticals International Inc. was lambasted by Congress for boosting prices of older drugs. In September, representatives grilled Mylan Chief Executive Officer Heather Bresch over the company’s sixfold price increase since 2007 to $600 for a pair of EpiPen allergy shots.

While attention so far has been focused mainly on branded drugs, which are more expensive, the Justice Department probe is now bringing the generics industry into the fray.

Although it isn’t illegal for companies to raise prices at the same time, it’s against the law for competitors to agree to set prices or coordinate on discounts, production quotas or fees that affect prices. The federal government can prosecute companies for collusion and seek penalties and potentially send executives to jail.

Charges could extend to high-level executives, according to the people. The antitrust division, which has an immunity program to motivate wrongdoers to confess and inform on others, has stepped up its commitment to holding individuals responsible.

CMS Walks Back Zero Allocation Approval New Requirement

It is possible to have CMS approve a Zero Allocation settlement. In such a case, nothing is set aside for payment of future medical care. However the Centers for Medicare and Medicaid Services (CMS) made news last month by purportedly “correcting” their position on zero allocations by adding a new, controversial requirement.

CMS announced on November 1, 2016 , that effective immediately, the Workers’ Compensation Review Contractor (WCRC) will utilize procedures that were previously in effect in reviewing zero MSAs. CMS’s purported “new” position basically adopted a three-part test for a Medicare Set-Aside (MSA) to qualify for a zero allocation: (1) The case or body part in question has been denied throughout the case; (2) There has been no medical or indemnity payment for the denied case or body part; and (3) There is either a finding from a hearing on the merits from a court of competent jurisdiction relieving the carrier of liability or documentation from the beneficiary’s treating physician recommending no future treatment.

In other words, under this new requirement CMS may only approve a zero allocation if a judge has determined that no compensable workers compensation claim exists and no payments were made.

For lack of a better term, a judicial determination “on the merits” would be a trial. Trials in cases that are settled are extremely rare and almost never occur. Seeking to avoid an up or down determination at trial – realizing that both sides have significant risk in a trial – the parties agree to settle a denied claim on a doubtful and disputed basis. If the insurer or employer wins at trial, the case is over. There is no settlement. This makes CMS’s purported requirement of a judicial finding nearly impossible – and certainly irrational – to comply with.

In response to negative feedback from the worker’s compensation community, CMS provided the following announcement on its “What’s New” page:

“CMS recently received inquiries regarding procedural changes in the way that CMS’ Workers’ Compensation Review Contractor (WCRC) reviews proposed zero-dollar Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) amounts. CMS determined changes had transpired without prior notification. Effective immediately, the WCRC will utilize procedures that were previously in effect. CMS continually evaluates all policy and procedures related to WCMSA reviews and will publish any pending changes when or before they go into effect.”

So, for now, CMS is maintaining the status quo when it comes to zero allocation review procedures. Until CMS makes a subsequent announcement, the basic requirements to obtain a zero allocation CMS approval remain as follows:

1) The claim is denied; and
2) No payments, medical or indemnity, have ever been made.

It now appears that CMS tested an additional requirement for zero allocations: that parties obtain an “on the merits” determination in addition to the above-referenced requirements. It ends up that this additional requirement would simply not work in certain jurisdictions or in true disputed settlements.

DWC Announces Registration for Educational Conference

The California Division of Workers’ Compensation (DWC) announced that registration for its 24th annual educational conference is now open. The conference will take place February 23-24, 2017 at the Los Angeles Airport Marriott and March 2-3, 2017 at the Oakland Marriott City Center Hotel.

Attendee, exhibitor, and sponsor registration forms may be downloaded from the conference website.

Conference registration flyers were recently mailed to more than 8,000 names on DWC’s mailing list. Registration forms are also available at the conference website and the front counters of the division’s district offices throughout California.

This annual event is the largest workers’ compensation training in the state and allows claims administrators, attorneys, medical providers, return-to-work specialists, employers, and others to learn firsthand about the most recent developments in the system. Attendees will be interested in learning about current topics on workers’ compensation from a variety of workers’ compensation experts from DWC, other state and public agencies, and the private sector.

DWC has applied for continuing educational credits by attorney, rehabilitation counselor, case manager, disability management, human resource and qualified medical examiner certifying organizations among others.

Paper copies of conference materials will no longer be given to attendees. Instead, DWC will provide flash drives. Attendees will also be able to download the handout materials through the conference website.

Organizations who would like to become sponsors of the DWC conference can do so by going to the website.

The 2016 conference had more than 1,900 attendees and 140 exhibitors, so early registration is encouraged.

State Farm Faces $7 Billion RICO Class Action

Property Casualty 360 reports that plaintiffs’ attorneys alleging that State Farm Mutual Automobile Insurance Co. bought off an Illinois Supreme Court justice to evade a $1.05 billion award have cleared a major hurdle in their long-running litigation against the insurer.

U.S. District Judge David Herndon of the Southern District of Illinois granted a motion certifying a class of roughly 4.7 million auto insurance policyholders who were allegedly deprived of their 1999 trial court victory against State Farm.

Herndon found that the alleged fixing of the state Supreme Court decision affected all the proposed class members uniformly, and that the named plaintiffs and their attorneys otherwise satisfied court rules around class actions.

A State Farm spokesman, said the company plans to appeal the ruling. “Plaintiffs have unsuccessfully asserted and reasserted these allegations for many years and should not be permitted to do so any longer.”

The suit stems from a 2005 decision by the Illinois Supreme Court that upended the billion-dollar judgement against State Farm. A jury had found the company defrauded policy holders by requiring the use of cheaper, non-manufacturer parts when repairs were made to covered vehicles after a crash, handing plaintiffs $1.18 billion in damages. An appeals court affirmed but reduced the amount of the award.

According to the complaint, filed in 2012, the state high court’s decision reversing the judgment was unfairly influenced by Justice Lloyd Karmeier, who State Farm and its agents worked to elect during a campaign in 2003 and 2004. Karmeier’s campaign received at least $4 million from the insurer and individuals connected to it, plaintiffs allege.

Illinois’ Supreme Court has seven justices, and the decision at issue was not authored by Karmeier. It won the support of four justices, with two issuing a dissent that still concurred on key holdings, and another abstaining. The court reversed the award against State Farm on the grounds that certification of a nationwide class of policyholders was improper, among other things.

RICO litigation has become a popular tool against insurance companies by disgruntled claimants, even within the workers’s compensation arena.

The Racketeer Influenced and Corrupt Organizations Act, commonly referred to as the RICO Act or simply RICO, is a United States federal law that provides for extended criminal penalties and a civil cause of action for acts performed as part of an ongoing criminal organization. Federal RICO allows a successful plaintiff to recover treble damages, plus attorney fees.

The plaintiffs bar has sought to apply RICO laws as a penalty in workers’ compensation claims for at least a decade with mixed results. Conceptually they allege that an employer, carrier or third party administrator concocts a fraudulent scheme that is used over and over to prevent workers from obtaining just benefits.

Workers’ compensation claimants recently lost a RICO case filed in California.

In the California case John Black, and a group of police officers and fire fighters asserted a RICO claim in their fourth amended complaint involving the City of Rialto and the City of Stockton, CorVel Enterprises, York Risk Services Group and others. These plaintiffs allege “York, CorVel, and Rialto engaged in a pattern of fraudulently denying and delaying legitimate claims in order to lower the liability of the city, while at the same time maximizing the TPA’s revenues (and allowing the TPA to maintain and obtain contracts with other public entities based on their ‘outstanding’ financial performance at the expense of public servants)”

National Pharmacy Chain Pays $2.24 Million in Fraud Case

Omnicare Inc., a national long-term care pharmacy, will pay a combined $2.24 million to resolve federal and state False Claims Act allegations that it improperly billed federal and state health care programs for prescription drugs that were dispensed to patients in skilled nursing and other institutional care facilities.

Specifically, the settlement resolves allegations that Omnicare employees manually altered the National Drug Code (NDC) field on claims resubmitted to Medicare, Medicaid, and TRICARE, in order to overcome prior rejection of these claims for payment. The alleged conduct occurred between January 1, 2006, and September 1, 2014, prior to CVS Health Corporation’s purchase of Omnicare.

As part of the settlement, CVS Health Corporation and its subsidiaries also entered into a five-year Corporate Integrity Agreement (CIA) with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) that covers their institutional pharmacy services operations. The CIA is designed to increase accountability and transparency and to avoid or promptly detect future fraud and abuse.

“We are committed to ensuring the integrity of the federal health care system, and this extends to paying only for drugs that accurately reflect an underlying prescription,” said Acting U.S. Attorney Talbert.

The allegations resolved by the settlement were first raised in a lawsuit filed against Omnicare under the qui tam, or whistleblower, provisions of the False Claims Act by a former Regional Servicer Area Director in Omnicare’s pharmacy in Lodi, California. The Act allows private citizens with knowledge of false claims to bring civil actions on behalf of the government and to share in any recovery. The whistleblower in this matter will receive approximately $411,624 of the recovery proceeds.

This case was pursued by Assistant United States Attorney Edward Baker through a coordinated effort with the Department of Health and Human Services Office of Inspector General and Office of General Counsel, the Civil Division of the Department of Justice, the Federal Bureau of Investigation, and the Defense Health Agency. A team from the National Association of Medicaid Fraud Control Units assisted with the investigation and participated in settlement negotiations on behalf of the states, and included representatives from the Offices of the Attorneys General for the states of California, Massachusetts, New York, Ohio, and Texas.

Opioid Medication Poisoning of Children and Teens “Surge”

The number of children and teens hospitalized for prescription opioid poisonings has more than doubled in recent years, with both accidental overdoses and suicide attempts on the rise, according to a new study published in the JAMA Pediatrics and summarized by Reuters Health.

Annually, the rate of these opioid poisonings among youth up to 19 years old surged from 1.4 per 100,000 children in 1997 to 3.71 per 100,000 kids by 2012, the study found.

“I believe that the two-fold increase in hospitalization rates over time for opioid poisonings in children are a direct consequence of the increasing reliance in the U.S. on opioid analgesics to treat acute and chronic pain,” said lead study author Dr. Julie Gaither, a public health researcher at Yale University in New Haven, Connecticut.

For teens aged 15 to 19, the rate of poisonings surged from 3.69 per 100,000 at the start of the study to 10.17 per 100,000 by the end, fueled in part by overdoses involving heroin and methadone, researchers report in JAMA Pediatrics.

“Trends we see in teens mirror what we’ve seen in adults – an increase in accidental overdoses (poisonings) from either taking an opioid as prescribed or, increasingly, using opioids for purposes other than to treat pain, including to get high or to enhance the effects of alcohol or other drugs,” Gaither noted by email.

With children 4 years old and under, the rate of poisonings climbed from 0.86 per 100,000 kids to 2.62 per 100,000 by the end of the study period.

“The vast majority of opioid poisonings in young children – toddlers and preschoolers – are the result of unsupervised ingestions of medications prescribed for an adult (parent, grandparent) in the household,” Gaither added.

To assess trends in poisonings over time, researchers examined data from 13,052 pediatric hospitalizations due to ingestion of prescription opioids. For teens, they also identified poisonings due to heroin.

Overall, 176 children, or 1.3 percent, died during hospitalizations for opioid poisoning during the study period.

Among teens in the study, poisonings from heroin increased by 161 percent from 0.96 to 2.51 per 100,000 children, while poisonings involving methadone increased by 950 percent from 0.10 to 1.05 per 100,000 children.

When the authors examined intent behind the opioid poisonings, there were 16 poisonings attributed to suicide or self-inflected injury among children younger than 10 from 1997 to 2012.

In children ages 10 to 14, the incidence of poisonings attributed to suicide or self-inflicted injury increased by 37 percent from 0.62 per 100,000 in 1997 to 0.85 per 100,000 in 2012. The incidence of poisonings attributed to accidental intent increased by 82 percent from 0.17 to 0.31.

For teens ages 15 to 19, opioid poisonings attributed to suicide or self-inflicted injury increased by 140 percent, while those attributed to accidental intent roughly tripled in this age group.

“It is a common practice for adults to place leftover opioid medications in the medicine cabinet or in the kitchen, which leaves them completely available to not only children and adolescents in the household but also any friends that come to visit,” said Dr. Constance Houck, a researcher at Harvard Medical School and Boston Children’s Hospital who wasn’t involved in the study.

“It is a well-known technique for adolescents with substance use issues to ask to use the bathroom in a friend’s or relative’s home and rifle through the medicine cabinet while alone in the bathroom,” Houck said. “Many adolescents have described this as a way that they have regularly obtained opioids.”