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The U.S. Department of Justice has been hot on the heels of some of pharma's biggest players in a yearslong probe into an alleged industrywide co-pay kickback scheme...Federal prosecutors accused Teva in a new lawsuit of paying kickbacks to two patient copay assistance charities as part of a scheme to pump up prescriptions of multiple sclerosis med Copaxone...The filing in a Boston district courthouse alleged the company paid more than $300 million to those third-party organizations and defrauded Medicare of "hundreds of millions" in reimbursements...READ MORE

The planned introduction of a wide-ranging bill granting certain businesses enhanced immunity from COVID-19 related death or illness lawsuits has drawn the ire of officials from hospitals and other health care facilities, who say it unfairly opens them up to the threat of lawsuits...the enhanced liability protections envisioned in the bill would be granted to casino resorts, government agencies, nonprofits and other kinds of business while explicitly carving out health care facilities...That exemption...has drawn a sharp rebuke from the Nevada Hospital Association and other health care providers, who say it would prohibit them from transferring patients between facilities or prohibit visitors from coming to visit patients...READ MORE

The American Hospital Association and Association of American Medical Colleges announced...they are seeking a rehearing on the ruling earlier this month from the U.S. Court of Appeals for the District of Columbia. The ruling upheld the Department of Health and Human Services’ authority to install Medicare payment cuts to off-campus hospital clinics to bring them to the same payment level as physician offices...“These illegal cuts directly undercut the clear intent of Congress to protect hospital outpatient deaprtments because of the many real and crucial differences between them and other sites of care,” the AHA and AAMC said in a statement...READ MORE

Robert Courtney, the former Kansas City pharmacist whose dilution of cancer medications led to the premature deaths of hundreds and possibly thousands of patients, will not be released from prison early...The decision to keep Courtney in prison would mark a reversal by the Bureau of Prisons to release him to a halfway house today and then to home confinement in Trimble, Missouri, because of the COVID-19 pandemic...Courtney was sentenced to 30 years in prison after he pleaded guilty in 2002 to various crimes associated with his drug dilution scheme...READ MORE

Hundreds of drug companies, medical device manufacturers, and universities owe the public a decade’s worth of missing data from clinical trials, federal officials warned last week...New rules issued last week in the wake of a federal court ruling in February instructed clinical trial sponsors to submit missing data for trials conducted between 2007 and 2017 “as soon as possible.” For years, many trials conducted during that span have largely been exempted from reporting their data to ClinicalTrials.gov, a public database, meaning a decade of data about approved drugs and medical devices has never been made public...The court’s ruling, and the federal government’s decision not to appeal it and instead to urge trial sponsors to submit the missing information, represent a major win for transparency advocates, who for years have fought to recover the decadelong gap in publicly available clinical trial data...READ MORE

A federal appeals court has ruled the Trump administration can install nearly 30% cuts to the 340B drug discount program...The ruling...is the latest legal setback for hospitals that have been vociferously fighting cuts the Department of Health and Human Services announced back in 2017...340B requires pharmaceutical manufacturers to deliver discounts to safety net hospitals in exchange for participation in Medicaid. A hospital will pay typically between 20% and 50% below the average sales price for the covered drugs...HHS sought to address a payment gap between 340B and Medicare Part B, which reimburses providers for drugs administered in a physician's office such as chemotherapy. There was a 25% and 55% gap between the price for a 340B drug and on Medicare Part B...So HHS administered a 28.5% cut in the 2018 hospital payment rule. The agency also included the cuts in the 2019 payment rule...Three hospital groups sued to stop the cut, arguing that HHS exceeded its federal authority to adjust the rates to the program...READ MORE

Oswald Bilotta blew the whistle on Novartis’ alleged doctor kickback scheme while working as a sales rep at the Swiss drugmaker, leading to U.S. government intervention in a lawsuit in 2013...Now, as Novartis has agreed to resolve the case by paying a $678 million settlement, Bilotta stands to get $109.4 million, plus additional interest, for his role as the whistleblower...According to the complaint, Novartis set up sham speaker programs as venues for paying physicians kickbacks to boost scripts of its drugs Lotrel, Valturna, Starlix, Tekturna, Tekamlo, Diovan and Exforge. These events often involved lavish meals, fishing trips and other entertainment, according to the suit...READ MORE

Unhappy with the price and availability of Gilead’s remdesivir—the only drug with FDA clearance to treat COVID-19—dozens of state attorney generals have called for the federal government to exercise march-in rights to allow for broader production of the medicine...In a letter to the heads of the FDA, HHS and NIH, 34 attorneys general wrote that Gilead has been unable to ensure “sufficient” supply and has priced the medicine out of reach for many patients who need it. Gilead is charging $3,120 per treatment course for patients with commercial insurance, Medicare or Medicaid, and $2,340 for patients on certain smaller federal programs...READ MORE

AstraZeneca has been granted protection from future product liability claims related to its COVID-19 vaccine hopeful by most of the countries with which it has struck supply agreements...With 25 companies testing their vaccine candidates on humans and getting ready to immunise hundred millions of people once the products are shown to work, the question of who pays for any claims for damages in case of side effects has been a tricky point in supply negotiations...“This is a unique situation where we as a company simply cannot take the risk if in ... four years the vaccine is showing side effects,” Ruud Dobber, a member of Astra’s senior executive team, told Reuters...READ MORE

A divided federal appeals court...upheld the Trump administration’s expansion of cheaper short-term health insurance plans, derided by critics as “junk insurance,” as an alternative to the Affordable Care Act’s costlier comprehensive insurance...The U.S. Court of Appeals for the District of Columbia Circuit said in a 2-1 decision that the administration had the legal authority to increase the duration of the health plans from three to 12 months, with the option of renewing them for 36 months. The plans do not have to cover people with preexisting conditions or provide basic benefits like prescription drugs...READ MORE