The delivery of health care and health care-related products and services is vastly different today than it was even five years ago. Whether you are a traditional health care provider or an emerging online company you need a law firm that has kept up with the changes and can provide comprehensive legal services to guide and protect you and your company in the digital age. Ifrah Law is that firm.
Ifrah Law represents major health, pharmaceutical and biotechnology companies and their executives, medical device manufacturers and distributors, health care lead generators, long-term care providers, wellness companies, insurance companies and agencies, and other health care-related entities. Our compliance counseling and enforcement and litigation defense practices bridge the gap between a more traditional health care industry and one that is increasingly internet-based.
Areas of Focus
• Advertising, promotion and labeling, including affiliate advertising agreements
• Anti-kickback and safe harbors
• Privacy and data security
• False Claims Act and “best pricing”
Online and Digital Health Care Practice
Whether helping a health care lead generator stay in compliance with anti-kickback regulations, advising a wellness company on advertising and promotional activities, or working with a health care provider to strengthen their privacy and data security policies and procedures, we help companies navigate the myriad legal and compliance requirements impacting their business. Drawing on both our traditional health care background, as well as our privacy, advertising and digital media experience we provide a powerful combination of legal services geared towards the reality of today’s regulatory and litigation landscape.
The core of our online and digital practice is focused at the intersection of advertising and health care regulation. We regularly advise clients on social media and digital advertising, sweepstakes and other promotional campaigns, anti-kickback regulations, affiliate advertising agreements, and privacy and data security issues.
Traditional Health Care Practice
We have represented some of the largest players in the health care and pharmaceutical industry, as well as their executives, in the defense of federal and state criminal prosecutions and in civil litigation. For example, we obtained a dismissal of a complaint alleging million dollar claims under the False Claims Act. We also successfully represented the owner of a pharmaceutical supply company who was indicted for multiple counts of false statements relating to commercial transactions in the secondary wholesale market. Through our persistence and responsiveness, we prevailed in convincing the U.S. Attorney handling the case to dismiss the indictment in its entirety.
Types of Companies We Represent
• Health care providers
• Health insurers
• Long-term care providers (skilled nursing facilities, hospice, home care)
• Wellness companies
• Health care lead generators
• Insurance companies and insurance agencies
• Medical device manufacturers and distributors
• Wearable technology and fitness tracker manufacturers and developers
• Diet pill and supplements companies
• Telemedicine providers
• e-Prescription companies
Statutes We Advise On
• Food, Drug and Cosmetic Act
• Sections 12-15 of the Federal Trade Commission Act
• Health Insurance Portability and Accountability Act (“HIPAA”)
• False Claims Act
• Stark Law
Government Agencies We Interact With
• State AGs
• HHS / HHS OIG
People are taking notice of the exceptional depth of experience Ifrah Law brings to our health care clients. In particular, our founding partner has been listed by Nightingale’s Healthcare News as one of 12 outstanding fraud and compliance attorneys in the U.S. and recognized by LexisNexis as a leading attorney in health care fraud.
After developing a solid online promotions program over several years with Michelle Cohen advising on sweepstakes and contests, Michelle’s long-standing client, a digital wellness company, decided to energize its online efforts with a celebrity endorsement sweepstakes. The celebrity, a known health advocate and popular entertainer, partnered with our client to give away VIP ticket packages to his sold out shows in multiple cities.
Michelle crafted sweepstakes rules and reviewed promotional materials, including social media campaigns. The celebrity also used social media to organize in-person athletic meet-ups around the country, as part of his current touring schedule. This coast-to-coast campaign included sweepstakes at the on-site events. Michelle worked with our client on several aspects of its campaign, including social media messaging, drafting winner’s eligibility affidavits and ensuring compliance with state and federal sweepstakes laws, as well as social networks’ policies and requirements.
The result? Michelle’s client continues to develop exciting and clever online promotions that will engage their audience, while complying with applicable laws and regulations and maintaining positive relationships with key social networks.
Our client, a prominent anesthesiologist, employed a medical services billing specialist to submit insurance claims for his practice and surgery center. The terms of the specialist’s contract stated that she would receive 18% of each claim she filed using a specific step-by-step submission and follow-up process.
After the billing specialist was terminated for not following the established submission procedures, she sued the doctor to retain her full commission on outstanding claims she had worked on prior to her dismissal, including those that hadn’t yet been paid. In addition to this contract dispute, she also accused our client and his surgery center of fraud, alleging that they funneled money into a “secret account” to avoid paying her commission under the contract.
Although there was very little basis for the fraud claim, the court allowed it to move forward. Jeff understood the importance of attempting a settlement on the contract claim, so he analyzed the agreement and claims reports and devised a methodology for valuing the claim. When the plaintiff refused to settle, Jeff and the client pursued mediation with confidence, understanding both the fair value of the case and specific details of the parties’ contract. During mediation, the plaintiff’s side raised several arguments that demonstrated their lack of familiarity with the contract. Jeff’s thorough understanding of certain provisions allowed the defendant to quickly address and dismiss the arguments. As a result, the plaintiff ended up settling for much less than she originally claimed.
While the settlement terms are confidential, our client was thrilled with the final result, not only with the amount and the dismissal of the fraud claims, but also in terms of how well the matter was handled.
When a company that is under investigation for money laundering decides to sell its assets, what was once a straightforward sales process becomes a complex negotiation. That is what happened with our client, a provider of diagnostic testing equipment.
Ifrah Law and Michelle Cohen represented the company in its sale of radiology and cardiology diagnostic services equipment, which involved numerous challenges. Understandably, the buyer was concerned about the ongoing criminal investigation, and Michelle worked closely with them to address their concerns about representations and warranties and possible post-sale seizure from the government. Additionally, since there were bank liens on some of the assets, Michelle worked with the bank’s outside counsel to arrange a prompt payoff, obtain a satisfactory pay-off letter and secure a release of the liens in order to close the deal. Michelle also worked with the buyer to create a creditor payment plan that would payoff unsecured creditors and obtain releases from them in order to address the buyer’s concerns about unsecured creditors seeking relief from the buyer. Finally, she created an employee fund (funded by the buyer) to pay for uncompensated leave time.
These complicated issues were resolved in less than two weeks, as a result of Michelle’s skilled negotiations with all parties. The buyer was represented by Delaware’s largest law firm.
Ifrah Law successfully defended a government contractor against claims by a terminated company employee. Our client, a health care professional supplier, faced allegations that it failed to offer the former employee COBRA insurance coverage, as required under the COBRA statute.
Ifrah Law conducted a bench trial in the U.S. District Court for the Eastern District of Virginia in January 2012. The judge sustained minimal claims and awarded the plaintiff a mere $500.
(Middlebrooks v. Godwin Corporation, U.S. District Court, Eastern District of Virginia, No. 1:10CV1306))
Jeff Ifrah successfully represented global health care leader Merck in a False Claims Act qui tam suit and got the case dismissed.
The suit involved a whistleblower that worked for a health care buying company (a group purchasing organization that purchases supplies and drugs). Terminated from the buying group, the employee alleged she was retaliated against because of issues she raised about the buying process.
The case was brought before the U.S. District Court for the Northern District of Texas, and 18 drug companies were named as defendants in an alleged bribery scheme. Jeff represented Merck, which was one of the named defendants. He filed a successful motion to dismiss the complaint, based on the former employee’s alarming lack of specificity in her claim.
Not only was our motion to dismiss successful, it was efficient: Jeff won the dismissal roughly one year after Merck and the other defendants were originally served.
(United States ex rel. Fitzgerald v. Novation LLC, et al., S.D. Tex., No. 3:03-CV-01589))
In March 2015, I wrote about the ongoing dispute between the FTC and LabMD, an Atlanta-based cancer screening laboratory, and looked at whether the FTC has the authority to take enforcement action over data-security practices alleged to be insufficient and therefore “unfair” under section 5(n) of the Federal Trade Commission Act (“FTCA”). On November 13, 2015, an administrative law judge ruled that the FTC had failed to prove its case.
In 2013, the FTC filed an administrative complaint against LabMD, alleging it had failed to secure personal, patient-sensitive information on its computer networks. The FTC alleged that LabMD lacked a comprehensive information-security program, and had therefore failed to (i) implement measures to prevent or detect unauthorized access to the company’s computer networks, (ii) restrict employee access to patient data, and (iii) test for common security risks.
The FTC linked this absence of protocol to two security breaches. First, an insurance aging report containing personal information about thousands of LabMD customers was leaked from the billing manager’s computer onto peer-to-peer file-sharing platform LimeWire, where it was available for download for at least eleven months. Second, Sacramento police reportedly discovered hard copies of LabMD records in the hands of unauthorized individuals. They were charged with identity theft in an unrelated case of fraudulent billing and pleaded no contest.
Incriminating as it all might seem, Administrative Law Judge D. Michael Chappell dismissed the FTC’s complaint entirely, citing a failure to show that LabMD’s practices had caused substantial consumer injury in either incident.
Section 5(n) of the FTCA requires the FTC to show that LabMD’s acts or practices caused, or were likely to cause, substantial injury to consumers. The ALJ held that “substantial injury” means financial harm or unwarranted risks to health and safety. It does not cover embarrassment, stigma, or emotional suffering. As for “likely to cause,” the ALJ held that the FTC was required to prove “probable” harm, not simply “possible” or speculative harm. The ALJ noted that the statute authorizes the FTC’s regulation of future harm (assuming all statutory criteria are met), but that unfairness liability, in practice, applies only to cases involving actual harm.
In the case of the insurance aging report, the evidence showed that the file had been downloaded just once—by a company named Tiversa, which did so to pitch its own data-security services to LabMD. As for the hard copy records, their discovery could not be traced to LabMD’s data-security measures, said the ALJ. Indeed, the FTC had not shown that the hard copy records were ever on LabMD’s computer network.
The FTC had not proved—either with respect to the insurance aging report or the hard copy documents—that LabMD’s alleged security practices caused or were likely to cause consumer harm.
The FTC has appealed the ALJ’s decision to a panel of FTC Commissioners who will render the agency’s final decision on the matter. The FTC’s attorneys argue that the ALJ took too narrow a view of harm, and a substantial injury occurs when any act or practice poses a significant risk of concrete harm. According to the FTC’s complaint counsel, LabMD’s data-security measures posed a significant risk of concrete harm to consumers when the billing manager’s files were accessible via LimeWire, and that risk amounts to an actual, substantial consumer injury covered by section 5(n) of the FTCA.
The Commissioners heard oral arguments in early March and will probably issue a decision in the next several months. On March 20th, LabMD filed a related suit in district court seeking declaratory and injunctive relief against the Commission for its “unconstitutional abuse of government power and ultra vires actions.”
The Office of the Inspector General, which enforces Health and Human Services, has long been averse to referral services that don’t meet certain criteria. To get protection against a possible enforcement action, the referral service can’t exclude anyone from participating in the service, and payments for referrals have to be reasonable and cannot be tied to the volume or value of the referrals that are made. All this complexity doesn’t simply keep referral services from earning a legitimate living; it denies patients access to superior healthcare options.
In a time when patients gravitate toward online resources, the OIG’s restrictions on medical referrals appear horribly out of date. Generally, when people want to find a pharmacy, lab, or doctor, they ask a friend or family member. In many circumstances, though—such as moving to a new city and not knowing anyone—people are likely to go online. Here they will find numerous referral services that can steer them to many reputable providers, who are often happy to pay for the hookup. This type of commercialized referral happens all the time in privatized industries—but because the government pays for healthcare (in the case of Medicare and Medicaid), it gets to set the rules for that space. Many of these rules are legitimately designed to protect against fraud and misuse of public funds, but that shouldn’t make them impervious to revision.
Thankfully, this has not escaped the notice of referral services and even the OIG, which has issued some enlightened opinions on the matter; case in point, No. 11-18. In 2011, a web-based provider of billing, electronic record, and patient messaging services asked if it could offer a coordination service whereby physicians could pay a transmission fee for connecting to other providers in order to share patient information, provider numbers, and clinical data. In response, the OIG determined that this service would not be afforded protection under the safe harbor, but it would not necessitate enforcement action either. In this instance, and many others in today’s marketplace, the referral service isn’t a health care provider that bills the government, but a third party provider of software and services. What would be the harm of facilitating the transmission of information between referring providers so that a patient can receive care? Here the OIG acknowledged that the fee structure was fair market value, that it would be assessed whether or not a patient followed through, and that it was unlikely to influence a provider’s decision to refer to any particular person or entity.
When the referral services safe harbor was drafted it made some sense for the OIG to suspect that an online referral service could charge a fee to steer patients to a particular provider, thereby exploiting federally reimbursed services and products. However, in most cases, online referral services are there simply to expand access to care, allow patients to have more choices, and help them find options that best suit their needs. In any other industry it makes perfect business sense for a referral service to charge its users a fee in order to recoup the cost of implementation (if any) and achieve a profit. It’s high time the OIG gives medical referral services the air they need to do the same. Modifying the safe harbor could take a lot of time and effort, but the OIG can take it upon itself to revise its interpretation of the safe harbor’s requirements without having to turn a blind eye to the law.
The U.S. Supreme Court recently held that Sarbanes–Oxley extends whistleblower protection, not just to employees of public companies, but to employees of private contractors and subcontractors that serve public companies. In a 6-3 decision, the Court rejected the First Circuit’s narrow construction of the statute in favor of the Labor Department’s more expansive interpretation. Now more than ever, affected contractors and subcontractors need to ensure they have robust policies in place for addressing whistleblower complaints.
Congress passed the Sarbanes–Oxley Act in 2002, the year after Enron’s collapse. The Act was intended to protect investors in public companies and restore trust in financial markets. It achieved these goals in part by providing whistleblower protection: 18 U.S.C. § 1514A makes it unlawful for employers to retaliate against employees who report suspected fraud. The provision certainly protects employees of publicly traded companies. It was less clear whether § 1514A protects employees of private contractors that service public companies. The plaintiffs in Lawson v. FMR, LLC, claimed it did.
Jackie Lawson and Jonathan Lang were employees of private companies that serviced the Fidelity family of mutual funds. As is often the case with mutual funds, the Fidelity funds were subject to SEC reporting requirements, but had no employees. Private companies contracted with the funds to provide accounting and investment advisory services. In this case, the private companies were Fidelity-related entities referred to collectively as FMR. Lawson was a 14-year veteran and Senior Director of Finance for her employer, Fidelity Brokerage Services. She alleged that she was constructively discharged after raising concerns about cost accounting methods for the funds. Zang was an 8-year veteran of Fidelity Management & Research Co. He alleged that he was fired for raising concerns about misstatements in a draft SEC registration statement related to the funds. Both plaintiffs sued for retaliation under § 1514A.
FMR responded by asking the district court to dismiss the claims on grounds that § 1514A protects employees of public companies, not employees of privately held companies. The trial judge rejected FMR’s argument, but the First Circuit Court of Appeals reversed. Months later, the Labor Department’s Administrative Review Board issued a decision in another case, making clear that ARB agreed with the trial judge. Last year, the Supreme Court agreed to consider the question.
On March 4, the Court issued its opinion that § 1514A shelters employees of private contractors, just as it shelters employees of public companies served by those contractors. Speaking for the majority, Justice Ginsburg explained that the Court’s broad construction finds support in the statute’s text and broader context. As relevant to the plaintiffs’ claims, § 1514A provides, “‘No public company . . . , or any officer, employee, contractor, subcontractor, or agent of such company” may take adverse action “against an employee . . . because of [whistleblowing or other protected activity].’” Boiled down to its essence, the phrase in question states that “no . . . contractor . . . may discharge . . . an employee.” In ordinary usage, the phrase means that no contractor (of a public company) may retaliate against its own employees. After all, those are the people contractors have power to retaliate against. According to the Court, if Congress had intended to limit whistleblower protections to employees of publicly traded companies, as FMR argued, Congress would have said “no contractor may discharge an employee of a public company.” The statute doesn’t say that because Congress was not attempting to remedy a nonexistent problem. Enron did not collapse because its private contractors retaliated against Enron employees who tried to report the company’s fraud.
The Lawson Court explained further that its interpretation flows logically from the statute’s purpose to prevent another Enron debacle. Often, the first-hand witnesses of corporate fraud are employees of private companies that service a public company—law firms, accounting firms, and business consulting firms, for example. Without adequate protections against retaliation, contractor employees who come across fraud in their work for public companies will be less likely to report misconduct. The Court’s point was particularly relevant with respect to the Fidelity funds. Like most mutual funds, the Fidelity funds had no employees. A narrow reading of § 1514A would insulate a $14 million industry from retaliation claims. Congress could not have intended that result.
Given the Court’s decision in Lawson v. FMR, LLC, privately held companies that service public companies should consider how best to deal with whistleblower complaints. At a minimum, robust whistleblower policies will (i) safeguard whistleblower anonymity to the extent possible; (ii) encourage whistleblowers to exercise discretion without discouraging them from reporting misconduct; (iii) address the preservation of evidence relating to putative fraud; and (iv) establish procedures for the conduct of internal investigations into suspected fraud.
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A recent decision by the Court of Appeals for the Fourth Circuit limiting the reach of the False Claims Act demonstrates how relators who pursue cases in which the government declines to intervene can end up making law that is unfavorable to the government’s enforcement of that statute.
United States ex rel. Rostholder v. Omnicare, Inc., et al., No. 12-2431, a qui tam case alleging violations of the False Claims Act (FCA), 31 U.S.C. §§ 3729, arose from a whistleblower’s claim that defendants violated certain Food and Drug Administration (FDA) safety regulations requiring that penicillin and non-penicillin drugs be packaged in complete isolation from one another. The violation of these regulations resulted in a legal presumption of penicillin cross-contamination. The relator asserted that the contaminated drugs were not eligible for reimbursement by Medicare and Medicaid and, therefore, claims presented to the government for reimbursement of these drugs were false under the FCA.
In affirming the district court’s grant of Omnicare’s motion to dismiss, the Court of Appeals focused on the specific requirement of the FCA that there be a claim that is, indeed, false. The Court noted that the statutes providing for reimbursement require that the drug in question be approved by the FDA but these statutes do not require compliance with FDA safety regulations as a precondition for reimbursement.
The Court therefore held that, while the cross-contamination might be a violation of safety regulations, it did not transform Omnicare’s requests for reimbursement into false claims. The Court observed statements in its own earlier cases that “the correction of regulatory problems is a worthy goal, but is ‘not actionable under the FCA in the absence of actual fraudulent conduct.’” (citing Mann v. Heckler & Koch. Def., Inc., 630 F.3d 338, 346 (4th Cir. 2010)). If it were “to accept relator’s theory of liability based merely on a regulatory violation,” the Court noted, “we would sanction use of the FCA as a sweeping mechanism to promote regulatory compliance, rather than a set of statutes aimed at protecting the financial resources of the government from the consequences of fraudulent conduct.” Given the FDA’s “broad powers to enforce its own regulations,” to permit the FCA to be used in this manner “could ‘short-circuit the very remedial process the Government has established to address non-compliance with those regulations.’” (citing U.S. ex rel. Wilkins v. United Health Grp., Inc., 659 F.3d 295, 310 3d Cir. 2011)).
Based on these principles, the Court of Appeals found that the relator had failed adequately to allege the existence of a false statute or fraudulent conduct, and that he could not plausibly allege that Omnicare acted with the requisite scienter when submitting the claims in question to the government.
This Court of Appeals decision could offer support for companies in highly regulated industries that face qui tam cases under the False Claims Act that arise from violations of safety regulations. In industries such as pharmaceutical manufacturing and packaging in which payment reimbursements are not expressly tied to compliance with safety rules, those companies may face regulatory enforcement for those violations, but will not also face assertions that they have also violated the False Claims Act.
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Fiscal year 2013 marked the fourth consecutive year in which the Department of Justice has recovered at least $2 billion from cases involving charges of healthcare fraud. Make no mistake: these record-setting yields were no accident. The Obama Administration has prioritized busting healthcare fraudsters since it took office, and for good reason. A 2009 analysis by the AHIMA Foundation, estimated that only 3 to 10 percent of healthcare fraud was being identified. To help crackdown, Attorney General Eric Holder and Human Services Secretary Kathleen Sebelius formed the Health Care Fraud Prevention and Enforcement Action Team (HEAT) in 2009.The Government also launched www.stopmedicarefraud.org in an effort to curb ongoing fraud. From January 2009 through the end of the 2013 fiscal year, the Justice Department used the False Claims Act to recover an unprecedented $12.1 billion in federal healthcare dollars.
In this past year alone, DOJ successfully recovered $2.6 billion. More than half of that amount related to alleged false claims for drugs and medical devices under federally insurance health programs, including Medicare, Medicaid and TRICARE.
Many of the DOJ settlements involved allegations that pharmaceutical manufacturers engaged in “off-label marketing” –that is, promoting sales of their drug products for uses other than those for which the Food and Drug Administration (FDA) approved them. A notable “off label” settlement was with Abbott Laboratories, which paid $1.5 billion to resolve allegations that it illegally promoted the drug Depakote to treat agitation and aggression in elderly dementia patients and schizophrenia – neither of which was the use for which the FDA had approved the drug as safe and effective. Abbott’s settlement included $575 million in federal civil recoveries, $225 million in state civil recoveries and nearly $700 million in criminal fines and forfeitures. DOJ also reached a settlement in 2013 with biotech giant Amgen, Inc., which paid $762 million (including $598.5 million in False Claims Act recoveries) over allegations that included promotion of Aranesp, approved to treat anemia, in doses and for purposes not approved by the FDA.
DOJ settlements in the past year also addressed allegations of the manufacture and distribution of adulterated drugs. For example, in May, Ranbaxy USA Inc. paid $505 million, including $237 million in federal civil claims, $118 million in state civil claims and $150 million in criminal fines and forfeitures, due to adulterated drugs from its facilities in India.
Kickbacks were the subject of other DOJ enforcement in 2013. DOJ obtained a $237 million judgment against Tuomey Healthcare System Inc. after a four week trial. Tuomey was accused of violations\ the Stark Law (which prohibits hospitals from submitting Medicare claims for patientsreferredto the hospital by physicians with a prohibited financial relationship with the hospital) and the False Claims act. Tuomey’s appeal is pending; if upheld, the judgment will be the largest in the history of the Stark Law. DOJ’s $26.3 million settlement with Florida dermatologist Steven J. Wasserman M.D., arising from allegations of illegal kickbacks from a pathology lab, was one of the largest with an individual in the history of the False Claims Act.
DOJ Civil Division’s Consumer Protection Branch was likewise active during 2013, obtaining 16 criminal convictions and more than $1.3 billion in criminal fines, forfeitures and disgorgement under the Federal Food, Drug and Cosmetic Act.
These numbers make clear that DOJ continues to view healthcare fraud as a priority. Providers and others who operate in this highly regulated space ignore this law enforcement focus at their peril in 2014.
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