Texas lawyer Kent Sullivan, who helped build a potent state health care fraud unit as the No. 2 lawyer in the Texas Attorney General’s office, is convinced that more states will follow Mississippi and Ohio in suing to recover damages related to the opioid epidemic, reports a post on the website of Androvett Legal Media & Marketing. Sullivan, now a partner in the Austin office of Jackson Walker LLP, says states wield “a huge hammer” over defendants through their tough anti-fraud laws.

“I expect a national trend, a significant wave of lawsuits against the companies and organizations connected with the spread of these powerful prescription drugs. States will be very tempted by the significant potential damages that may be awarded in court to try to recoup some of the costs of treatment.

“There is, of course, a way to successfully defend these cases, but at the beginning, state governments have a huge advantage under Medicaid fraud and consumer protection statutes. There is an easier burden of proof and enhanced damages available under these laws. Intent or negligence often is not required to prove liability. You have a huge hammer over these companies’ heads, and they can be at risk of losing more than actual damages. The damages are often multiplied if you’re found liable, and the states can often recover attorneys’ fees.

“As government health care has expanded, so have anti-fraud actions by states. These lawsuits are not part of the traditional private party litigation framework, where the burden of proof is higher. In many cases, the defendants consider settlement to avoid the significant risk and high cost of litigation. It is fairly unusual for these cases to go to trial but, as I often tell clients, the way to obtain the best settlement is to be totally ready for trial.”

Sullivan, a former appeals court judge, was chief deputy AG to then-Attorney General Greg Abbott and ramped up the state’s Civil Medicaid Fraud Division from four lawyers to over 40. In 2012, Texas won a $158 million settlement from Johnson & Johnson over its improper marketing of the anti-psychotic drug Risperdal to patients on Medicaid from 1994-2008. It was the largest Medicaid settlement in Texas history and is believed to be the first settlement paid at that time to any state in the nationwide litigation over Risperdal.

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MentorHealth will present a webinar, HIPAA and the Compliance Officer, addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur.

The 90-minute event will be Wednesday, August 9, 2017, 10 a.m. PDT (1 p.m. EDT).

The webinar also will address major changes under the Omnibus Rule and any other applicable updates for 2017. Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT.

On its website, MentorHealth says the primary goal is to ensure everyone is well educated on what is myth and what is reality with this law.

“I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors,” says instructor Brian Tuttle. “I will also speak to real life litigated cases I have worked where HIPAA is being used to justify state cases of negligence -THIS IS BECOMING A HUGE RISK! In addition, this course will cover the highest risk factors for being sued as well as being audited (these two items tend to go hand in hand).”

Topics will include:

• Do you have an affective HIPAA compliance program?
• New laws and funding mean increased risk for both business associates and covered entities
• HIPAA Omnibus – Do you know what’s involved and what you need to do?
• What does Omnibus mean for covered entities and business associates?
• Why should you be concerned?
• Court cases that are changing the landscape of HIPAA and patient’s ability to sue

“It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates as it relates to what we need to do as compliance officers,” according to Tuttle. “You need to know how to avoid being low hanging fruit in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT or internal administrative practices.”

Speaker Profile
Brian L Tuttle, CPHIT, CHP, CBRA, Net+, A+, CCNA, MCP is a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified Business Resilience Auditor (CBRA) with over 15 years’ experience in Health IT and Compliance Consulting.

Register for the webinar.

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Health records software developer eClinicalWorks has agreed to pay a $155 million to the federal government for civil fraud and kickback charges, according to HIT Consultant.

“Both the government and the whistleblower alleged that eClinicalWorks falsely represented to customers that its EHR [electronic health record] system complied with Meaningful Use requirements,” the publication says. “The settlement marks the first time an EHR vendor is being charged for the truthfulness and accuracy of representations made when seeking government certification of its EHR system and the government applying the federal Anti-Kickback Statute (AKS) law to the promotion and sale of EHR systems.”

The whistleblower alleged the company modified its software to pass testing, without being fully functional. The lawsuit listed several allegations against the company, such as kickbacks for recommendations, and failure to test its software adequately before releasing it.

Read the HIT Consultant article.

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Reuters is reporting CVS Health Corp’s Omnicare unit has agreed to pay $23 million to resolve a whistleblower lawsuit alleging that it took kickbacks from a drugmaker to promote two antidepressants, according to settlement papers.

The agreement comes out of a 2007 lawsuit against the pharmacy operator by two former employees of drugmaker Organon USA Inc on behalf of the federal government and various states.

“The lawsuit claimed that from 1999 to 2005, Omnicare and certain pharmacies it acquired sought and received kickbacks from Organon in the form of discounts in exchange for promoting the antidepressants Remeron and Remeron SolTabs,” writes Nate Raymond.

Former Organon employees Richard Templin and James Banigan filed the suit, which reached a related $31 million settlement in 2014.

Read the Reuters article.

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Fortune is reporting that AbbVie’s Humira, the best-selling drug on the planet with a staggering $14 billion in 2016 sales, has lost a key patent battle with a prospective rival product by the small biotech Coherus Biosciences.

Reporter Sy Mukherjee explains that “The rheumatoid arthritis and psoriasis medicine has recently been a target of biopharma companies that are trying to make generic Humira copycats called ‘biosimilars.’ That’s not surprising given both Humira’s market reach and the steep price of the brand name medication — which has a list price of about $4,500 for a set of two syringes before discounts and rebates, making it a prime target for cheaper alternatives.”

Humira sales make up more than 60 percent of AbbVie’s revenues.

Read the Fortune article.

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The U.S. Justice Department has accused UnitedHealth Group Inc. of obtaining inflated payments from the government based on inaccurate information about the health status of patients enrolled in its largest Medicare Advantage Plan, Reuters is reporting.

The accusation against the company is the latest, following separate lawsuits in two separate whistleblower lawsuits against the country’s largest health insurer.

“Medicare Advantage, an alternative to the standard fee-for-service Medicare in which private insurers manage health benefits, is the fastest growing form of government healthcare, with enrollment of 18 million people last year,” writes reporter Nate Raymond.

A UnitedHealth spokesman said the company rejects the claims and will contest them vigorously.

Read the Reuters article.

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The widow of a partner at the Reed Smith law firm won a $3 million verdict Thursday in a lawsuit against a pharmaceutical company that she blamed for her husband’s suicide, reports The Chicago Tribune.

“Wendy Dolin’s husband, Stewart, stepped in front of a CTA Blue Line train in the Loop on July 15, 2010. He had been taking paroxetine, a drug for depression and anxiety, and his widow claimed in her lawsuit that GlaxoSmithKline failed to warn her husband’s doctor of the drug’s increased risk of suicidal behavior, leading to his death,” writes reporter Grace Wong.

GlaxoSmithKline’s defense was that Dolin was taking a generic version of Paxil, manufactured by another company. But the judge hearing the case released the maker of the generic, saying it had no control of the drug’s label.

Read the Tribune article.

A recent decision of the Arizona Court of Appeals provides guidance for evaluation of the enforceability of arbitration agreements in the health care field, reports Snell & Wilmer in its Health Law Checkup blog.

Andrew Sniegowski explains that Gullett v. Kindred Nursing Centers West, LLC arose out of the plaintiff’s claims that a rehabilitation center had abused and neglected his father, who lived there for the last month of his life. The plaintiff argued that the arbitration agreement was substantively and procedurally unconscionable.

The court determined that the agreement was substantively valid, but it remanded the case for further proceedings in the trial court limited to the issue of procedural unconscionability.

Read the article.

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The generic drug industry has come under fire the last couple of years because of staggering price increases, but now generic drug executives can expect to face tougher legal repercussions, reports MedCity News.

The efforts come in the wake of a 500 percent hike in the generic price of the EpiPen and the 5,400 percent jumpin the price of Daraprim for the treatment of potentially deadly parasite infections, writes Johanna Mayer.

In November 2016, Heritage Pharmaceuticals Inc. sued two of its former executives, Jeffrey Glazer and Jason Malek, using the Racketeer Influenced and Corrupt Organizations Act (RICO). And in December 20 states sued six companies, including Heritage, after a major antitrust investigation by the state of Connecticut.

“Experts predict that these diverse types of lawsuits could ignite a legal domino effect,” Mayer writes. “They also suspect that, as cases like these develop, they’ll expand to touch multiple prongs of the pharmaceutical industry, such as wholesale manufacturers and pharmacies.”

Read the MedCity News article.

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Robert A. Wade, who has counseled healthcare institutions for more than 25 years, has joined Barnes & Thornburg LLP’s South Bend office as a partner in the Healthcare Department.

Wade represents large health systems, hospitals, ambulatory surgical centers, physician groups, physicians and other medical providers on a variety of legal issues.

“We are excited to have Bob join Barnes & Thornburg, as he brings a tremendous wealth of experience,” said Laura Seng, chair of the firm’s healthcare department. “The healthcare industry has undergone numerous changes in recent years and will continue to evolve. Bob’s addition to our healthcare team will provide clients with important counsel on critical issues they face.”

Wade has experience with matters involving the Stark Law, Anti-Kickback Statute, False Claims Act, and Emergency Medical Treatment and Active Labor Act, the firm said in a news release. Additionally, he counsels clients in developing, monitoring and documenting effective healthcare compliance programs. He also represents healthcare clients being investigated by the U.S. Department of Justice and the Office of Inspector General. Currently, he serves as Compliance Expert to the Board of Commissioners of Halifax Health, a hospital system in Daytona Beach, Florida, advising on all aspects of their Corporate Integrity Agreement.

The release continues:

Wade joins the firm’s national healthcare group that advises all types of providers on complex regulatory issues related to Medicare and Medicaid compliance, adherence to state and federal licensure regulations, and the impact of the Affordable Care Act, among other issues.

He is a frequent speaker at national and regional healthcare legal, compliance and regulatory conferences. He has been recognized on The Best Lawyers in America and Indiana Super Lawyers lists for his work in healthcare law since 2009. He serves on the editorial advisory boards for Strategies for Health Care Compliance and for the Report on Medicare Compliance.

Wade earned his J.D., summa cum laude, from The Ohio State University Moritz College of Law, where he served as the managing editor for The Ohio State University Law Journal and was a member of the Order of the Coif and Omicron Delta Kappa. He received his bachelor’s degree, summa cum laude, from Bowling Green State University.

A day after a Dallas jury found a neurosurgeon guilty of intentionally crippling an elderly woman he operated on, a string of his former patients and co-workers testified in his sentencing trial, reports The Dallas Morning News.

Christopher Duntsch of Colorado has been in jail since his arrest in July 2015, charged with five aggravated assault charges after four of his patients were maimed and two died between July 2012 and June 2013, reports Claire Ballor.

“His trial focused only on a first-degree felony charge: injury to an elderly person. Mary Efurd was 74 years old in 2012 when Duntsch promised to fix her back pain but instead damaged her spinal cord and amputated part of a nerve,” writes Ballor.

Read the Dallas News article.

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A bill in the Texas House seeks to end regulations that require nurse practitioners to contract with doctors in order to treat and write prescriptions. The proposal, HB1415, would give nurse practitioners (NPs) in Texas the freedom and flexibility they have been seeking for decades, reports Androvett Legal Media & Marketing.

It also would cut costs for both patients and providers, according to attorney Bill Hopkins of the Austin office of Shackelford, Bowen, McKinley & Norton, LLP.

“From the start, there has been a fundamental tension between their role and the role of the physician in the health care setting,” says Hopkins, who advises both individual and institutional health care providers on matters involving administrative law, regulatory defense and litigation. “No one has ever questioned that the physician is at the top of the pyramid. But over the years there has been some question as to whether there was some room at the top for the nurse practitioner who can drastically improve access to care.”

Currently NPs must complete four years of nursing school and two years in a graduate-level training program. Although they are regulated by both the Texas Board of Nursing and the Texas Medical Board, regulations require a doctor to supervise – even if the physician is not physically present and does not even see the patient, says Hopkins. Similar regulations have been rolled back in other states, with no evidence of increased safety issues, he says, adding that in some studies, nurse practitioner safety has ranked as high or higher than doctor care.

“For many years, NPs have argued that their knowledge, ability and training were more than sufficient to allow them to practice independently, care for patients and ensure safety,” he says. “The justification for charging NPs for this ‘supervision’ traditionally has been that it is a necessary cost to ensure patient safety. But thanks to the Affordable Care Act, there are more people with insurance than ever before and access has become a primary concern. With the safety argument becoming less relevant and calls for better access getting louder, it looks like this may be the time for NPs to finally get the independence that they have sought.”

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Healthlaw Publishing announces the upcoming release of Healthcare and the False Claims Act, 2016 Survey. Registration is available now for free downloading of the survey report.

Healthcare and the False Claims Act, 2016 Survey summarizes the important laws, regulations, pronouncements, and cases of the past year, to inform healthcare providers and healthcare attorneys on this crucial statute in the healthcare industry.

On Dec. 14, 2016, the United States Department of Justice announced the recovery of more than $4.7 billion in False Claims Act (“FCA”) settlements and judgments. It was the third-highest total in history, and more than $2.5 billion came from the healthcare industry. During the eight years of the Obama Administration, the Department of Justice recovered more than $31 billion in FCA settlements and judgments, taking more than $19.3 billion from healthcare providers and other participants in the healthcare industry.

2016 was a pivotal year for the FCA. It was the year of a tremendously important Supreme Court decision that could expose healthcare providers to whole new areas of FCA liability based upon state and federal regulations. The penalties were more than doubled to a minimum of more than $11,000 per claim and a maximum of more than $22,000 per claim, massively increasing both the risk of litigation and the likelihood of settling FCA cases even in the absence of wrongdoing. And it saw a new focus on the investigation and even the criminal indictment of individuals involved with entities sued under the FCA. 2016 also saw new regulations and new court interpretations of laws first put in place in 2009 and 2010 to turbocharge the FCA and encourage greater participation by whistleblowers.

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A federal judge blocked the $54 billion merger between health insurance giants Anthem and Cigna, saying the deal would increase prices and reduce competition, according to a report by The Washington Post.

Carolyn Y. Johnson reports that this ruling is the second recent court decision to uphold the Justice Department’s opposition to deals that would have consolidated the five largest insurers in the United States into three companies.

“The evidence has also shown that the merger is likely to result in higher prices, and that it will have other anticompetitive effects: it will eliminate the two firms’ vigorous competition against each other for national accounts, reduce the number of national carriers available to respond to solicitations in the future, and diminish the prospects for innovation in the market,” U.S. District Judge Amy Berman Jackson wrote in a 12-page order.

In the merger agreement, Anthem had agreed to pay Cigna a $1.85 billion termination fee if the deal is blocked because of regulatory interference.

Read the Washington Post article.

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In 2016, two federal juries in Dallas delivered significant verdicts on behalf of the victims of serious medical complications caused by defective metal-on-metal hip implants made by Johnson & Johnson and its subsidiary DePuy Orthopaedics Inc., according to a post by the plaintiffs’ legal counsel, The Lanier Law Firm.

Although the court has reduced the amount of punitive damages awarded by the juries in each case, and those judgments are under appeal by The Lanier Law Firm, the two verdicts still total almost $700 million in actual and punitive damages assessed against Johnson & Johnson and DePuy.

In the post, the firm said these verdicts marked the second and third bellwether trials among thousands of similar lawsuits nationwide that have been consolidated in multidistrict litigation (MDL 3:11-md-0244) in the U.S. District Court for the Northern District of Texas. A bellwether trial is one that is typically representative of all the issues involved in the litigation of a mass tort case.

Read the article.

Compliancy Group will present a complimentary webinar examining the major breaches and fines that made 2016 the most expensive year on record for HIPAA fines and enforcement.

The event will be Wednesday, Jan. 25, at 2 p.m. Eastern time.

HIPAA experts at Compliancy Group will analyze the causes of these breaches, the reasons for these substantial fines (almost $24 million in total), trends in compliance, and what to expect from OCR investigations in 2017.

Register for the webinar.

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NBC News is reporting that about 18 million people would lose or drop their health insurance in the first year after Obamacare is repealed, the Congressional Budget Office reported Tuesday.

“The nonpartisan federal agency also found that health insurance premiums would spike another 20 to 25 percent, according to the new report. Within 10 years, 32 million more people would be without health insurance, the CBO projects,” writes Maggie Fox.

The report’s projections are based on the repeal law passed in the House of Representatives last year, using a budget-based process called reconciliation, the same process that Congress is working on now.

Read the NBC article.

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It turns out a law degree is just as helpful in launching a medical marijuana business as it is dealing with mortgages, according to a report in The Chicago Tribune.

Charlie Bachtell, CEO and co-founder of medical marijuana company Cresco Labs, was general counsel at Chicago-based mortgage company Guaranteed Rate before he moved into the legal cannabis business, reports Ally Marotti.

In a question-and-answer session, he discusses how he decided to switch fields, the stigma that can be attached to his new business, securing financing, and growing the business.

Read the Chicago Tribune article.

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Veteran trial lawyer Jay Old has joined commercial litigation firm Hicks Thomas LLP where he will continue to represent construction, insurance, petrochemical and health care companies as part of his client portfolio.

Old’s addition will add offices in Austin and Beaumont. Old joined the firm effective Jan. 1.

“We are thrilled to be adding Jay and his team. He’s an exceptional lawyer with an outstanding track record,” said John B. Thomas, name partner and firm co-founder. “Many of us have known Jay for years, dating back to our days together at Andrews Kurth.”

Old’s clients include refineries, construction contractors, manufacturers, hospital systems and insurers. Joining him is labor and employment lawyer Jim Henges, along with four other lawyers from Old’s firm.

“I like to say I represent the job creators,” Old said. “I’m very excited to be joining the Hicks Thomas team, and hope to add to its reputation as a premier trial firm.”

Old is a frequent speaker at continuing education programs for lawyers across the country. He also is a former president of the Texas Association of Defense Counsel and has chaired the Construction Law Section of the State Bar of Texas.

He has defended national clients in statewide and regional mass tort litigation, in toxic torts, construction and product liability cases. He also successfully defended insurance companies in a series of high-profile trials involving hailstorm claims in Galveston and elsewhere.

Old is Board Certified in Personal Injury Trial Law by the Texas Board of Legal Specialization and has been recognized on the Texas Super Lawyers list every year since 2005. A native of Beaumont, he is a graduate of Texas A&M University and the Texas Tech University School of Law.

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