WORLD NEWS FLASH
UNITED STATES
On March 13, the Justice Department announced that the United States has filed a complaint in intervention in a whistleblower lawsuit brought under the False Claims Act (FCA) against Rite Aid Corporation and various subsidiaries (collectively Rite Aid) alleging that Rite Aid knowingly filled unlawful prescriptions for controlled substances. In addition to alleging claims under the FCA, the government’s complaint also alleges violations of the Controlled Substances Act (CSA). Rite Aid is one of the country’s largest pharmacy chains, with over 2,200 pharmacies in 17 states.
The government’s complaint alleges that, from May 2014 through June 2019, Rite Aid knowingly filled at least hundreds of thousands of unlawful prescriptions for controlled substances that lacked a legitimate medical purpose, were not for a medically accepted indication, or were not issued in the usual course of professional practice.
These unlawful prescriptions included, for example, prescriptions for the dangerous and highly abused combination of drugs known as “the trinity,” prescriptions for excessive quantities of opioids, such as oxycodone and fentanyl, and prescriptions issued by prescribers whom Rite Aid pharmacists had repeatedly identified internally as writing illegitimate prescriptions.
The government alleges that Rite Aid pharmacists filled these prescriptions despite clear “red flags” that were highly indicative that the prescriptions were unlawful. The government further alleges that Rite Aid not only ignored substantial evidence from multiple sources that its stores were dispensing unlawful prescriptions, including from certain pharmacists, its distributor, and its own internal data, but compounded its failure to act by intentionally deleting internal notes about suspicious prescribers written by Rite Aid pharmacists and directing district managers to tell pharmacists “to be mindful of everything that is put in writing.”
By knowingly filling unlawful prescriptions for controlled substances, the government alleges that Rite Aid violated the CSA and, where Rite Aid sought reimbursement from federal healthcare programs, also violated the FCA.
Along with Rite Aid Corporation, the government’s complaint names as defendants the following Rite Aid subsidiaries: Rite Aid Hdqtrs, Corp.; Rite Aid of Connecticut, Inc.; Rite Aid of Delaware, Inc.; Rite Aid of Maryland; Rite Aid of Michigan; Rite Aid of New Hampshire; Rite Aid of New Jersey; Rite Aid of Ohio; Rite Aid of Pennsylvania; and Rite Aid of Virginia.
Whistleblowers Andrew White, Mark Rosenberg, and Ann Wegelin, who all previously worked for Rite Aid at various pharmacies, filed an action in October 2019 under the qui tam provisions of the FCA. Those provisions authorize private parties to sue on behalf of the United States for false claims and share in any recovery. The Act permits the United States to intervene and take over the lawsuit, as it has done here in part. Those who violate the Act are subject to treble damages and applicable penalties. The case is captioned United States ex rel. White et al. v. Rite Aid Corp., et al., No. 1:21-cv-1239 (N.D. Ohio).
The United States’ intervention in this matter illustrates the government’s emphasis on combating health care fraud. One of the most powerful tools in this effort is the FCA. Tips and complaints from all sources about potential fraud, waste, abuse and mismanagement can be reported to the Department of Health and Human Services, at 800-HHS-TIPS (800-447-8477).
This matter is being handled by the Civil Division’s Commercial Litigation Branch (Fraud Section) and the U.S. Attorney’s Office for the Northern District of Ohio. The DEA Cleveland Field Division, FBI Cleveland Field Office, and HHS-OIG provided substantial assistance in the investigation.
The United States is represented in this matter by Senior Trial Counsel Christopher Wilson of the Civil Division’s Fraud Section and Assistant U.S. Attorneys Patricia Fitzgerald and Elizabeth Berry for the Northern District of Ohio.
Claims asserted against defendants are allegations only and there has been no determination of liability.
WORLD
HOLD THE SALT
A first-of-its-kind World Health Organization (WHO) Global report on sodium intake reduction shows that the world is off-track to achieve its global target of reducing sodium intake by 30% by 2025.
Sodium, an essential nutrient, increases the risk of heart disease, stroke and premature death when eaten in excess. The main source of sodium is table salt (sodium chloride), but it is also contained in other condiments such as sodium glutamate. The report shows that only 5% of WHO Member States are protected by mandatory and comprehensive sodium reduction policies and 73% of WHO Member States lack full range of implementation of such policies.
Implementing highly cost-effective sodium reduction policies could save an estimated 7 million lives globally by 2030. It is an important component of action to achieve the Sustainable Development Goal target of reducing deaths from noncommunicable diseases. But today, only nine countries (Brazil, Chile, Czech Republic, Lithuania, Malaysia, Mexico, Saudi Arabia, Spain and Uruguay) have a comprehensive package of recommended policies to reduce sodium intake.
“Unhealthy diets are a leading cause of death and disease globally, and excessive sodium intake is one of the main culprits,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “This report shows that most countries are yet to adopt any mandatory sodium reduction policies, leaving their people at risk of heart attack, stroke, and other health problems. WHO calls on all countries to implement the ‘Best Buys’ for sodium reduction, and on manufacturers to implement the WHO benchmarks for sodium content in food.”
A comprehensive approach to sodium reduction includes adopting mandatory policies and WHO’s four “best buy” interventions related with sodium which greatly contribute to preventing noncommunicable diseases. These include:
- Reformulating foods to contain less salt, and setting targets for the amount of sodium in foods and meals
- Establishing public food procurement policies to limit salt or sodium rich foods in public institutions such as hospitals, schools, workplaces and nursing homes
- Front-of-package labelling that helps consumers select products lower in sodium
- Behavior change communication and mass media campaigns to reduce salt/sodium consumption
Countries are encouraged to establish sodium content targets for processed foods, in line with the WHO Global Sodium Benchmarks and enforce them though these policies.
Mandatory sodium reduction policies are more effective, as they achieve broader coverage and safeguard against commercial interests, while providing a level playing field for food manufacturers. As part of the report, WHO developed a Sodium country score card for Member States based on the type and number of sodium reduction policies they have in place.
“This important report demonstrates that countries must work urgently to implement ambitious, mandatory, government-led sodium reduction policies to meet the global target of reducing salt consumption by 2025,” said Dr Tom Frieden, President and CEO of Resolve to Save Lives, a not-for-profit organization working with countries to prevent 100 million deaths from cardiovascular disease over 30 years.
“There are proven measures that governments can implement and important innovations, such as low sodium salts. The world needs action, and now, or many more people will experience disabling or deadly – but preventable – heart attacks and strokes.”
The global average salt intake is estimated to be 10.8 grams per day, more than double the WHO recommendation of less than 5 grams of salt per day (one teaspoon). Eating too much salt makes it the top risk factor for diet and nutrition-related deaths. More evidence is emerging documenting links between high sodium intake and increased risk of other health conditions such as gastric cancer, obesity, osteoporosis and kidney disease.
WHO calls on Member States to implement sodium intake reduction policies without delay and to mitigate the harmful effects of excessive salt consumption. WHO also calls on food manufacturers to set ambitious sodium reduction targets in their products.
To read the report, visit: https://www.who.int/publications/i/item/9789240069985.
WORLD
MORE HELP NEEDED IN TURKEY & SYRIA
The UN High Commissioner for Refugees, Filippo Grandi, on March 13 underlined the need for greater and urgent international support for survivors of the recent deadly earthquakes in Syria and Türkiye following a five-day visit to the two countries.
Mr. Grandi met with people who have been affected by the catastrophe, as well as aid workers on the ground. He also reviewed and discussed the immediate humanitarian response with the authorities.
The first of the earthquakes struck on Feb. 6, killing some 54,000 people across the region, according to the UN refugee agency, UNHCR, which he heads.
They also caused massive destruction in an area where more than 23 million people live, including millions who have been displaced inside Syria, or forced to cross the border, due to the war, now in its 12th year.
“The level of destruction and devastation is shocking and in many places it is apocalyptic,” he said. “Millions have suffered loss, injury and trauma, and many others have been displaced by this tragic and terrible event.”
Mr. Grandi visited Ankara, Hatay and Gaziantep in Türkiye. In Syria, he travelled to Latakia, Hama, and Damascus, and undertook a cross-border visit to earthquake-affected and other displaced people in the northwest.
UN convoys have been transporting aid into northwest Syria – the last opposition stronghold – since 2014, and via a single crossing point. More than four million people were already in need prior to the earthquakes.
Aid deliveries were temporarily halted in the aftermath, due to damage along key roads, but resumed within days. Syria subsequently agreed to the opening of two more aid corridors.
UNHCR and humanitarian partners, especially national and local responders, continue to step up assistance in the two countries. Since the earthquake, UNHCR has delivered tens of thousands of tents, beds, mattresses, thermal blankets and other desperately needed support.
Mr. Grandi said needs on the ground are enormous, underscoring that more funding is crucial.
“While it is critical to think about and support longer-term efforts, much more humanitarian aid and early recovery resources are needed so that people can begin to rebuild their lives and livelihoods,” he added.
The UN is seeking $1 billion for the humanitarian response in Türkiye and nearly $400 million for Syria. UNHCR’s part of the response plans totals just over $200 million.
To date, the Türkiye appeal is just two percent funded, while the Syria appeal stands at 10 percent.
While in Türkiye, Mr. Grandi met Turkish and Syrian families who had lost everything in the earthquake and were now living in a container camp, alongside thousands of others.
In Syria, he met families in collective shelters who had been displaced multiple times – first by the war, and now by the earthquake.
Twelve years of fighting have inflicted immense hardship on the Syrian people, and more than 90 percent of the population live below the poverty line. Infrastructure, including water, electricity and other basic services, have been battered.
“I have been coming to Syria regularly for almost 20 years, but never have I seen such levels of deprivation and desperation – everywhere I have been,” Mr. Grandi remarked.
EUROPE
ENERGY ASSISTANCE CONTINUING
On March 15, the Chancellor of His Majesty’s Treasury announce that the Energy Price Guarantee, which is protecting households by capping typical energy bills at £2,500, will be maintained at the same level for a further three months over April, May, and June, worth £160 in total for a typical household.
The Chancellor announcing the extension as part of his Spring Budget, which focuses on easing the impact of rising prices, delivering on our promise to halve inflation, and growing the economy by supporting more people into work.
Government support has already cut the typical family energy bill by over £1,300 since October, stopping the average household energy bill hitting £4,279 a year this winter.
The Chancellor’s three-month extension of the Energy Price Guarantee at £2,500 means households won’t feel the full force of Ofgem’s Price Cap between April and June – which stands at £3,280 – helping to bridge consumers into the summer.
Lower wholesale gas prices are expected to feed through to lower household energy bills from July, where Cornwall Insight data suggests the Ofgem Price Cap will reach an estimated £2,100 a year for a typical household.
From April, more support is coming online with 8 million low income and vulnerable households set to receive at least £900 in cash payments over the next year, benefits and pensions set to rise by over 10 percent, and the National Living Wage increasing to a record £10.42 an hour, so that it always pays to work.
The Spring Budget will go even further, providing hundreds of pounds more in help with childcare costs for parents on Universal Credit and ending the energy premium paid by households who use prepayment meters, which will save four million families £45 a year from July.
Prime Minister Rishi Sunak said, “We know people are worried about their bills rising in April, so to give people some peace of mind, we’re keeping the Energy Price Guarantee at its current level until the summer when gas prices are expected to fall.
“Continuing to hold down energy bills is part of our plan to help hardworking families with the cost of living and halve inflation this year.”
Chancellor Jeremy Hunt said, “High energy bills are one of the biggest worries for families, which is why we’re maintaining the Energy Price Guarantee at its current level. With energy bills set to fall from July onwards, this temporary change will bridge the gap and ease the pressure on families, while also helping to lower inflation too.”
Energy Secretary, Grant Shapps said, “Putin’s illegal war has cost British families, which is why we’ve stepped in to pay around half of the typical household energy bill.
“With wholesale prices falling families will start to benefit, but in the meantime we’re stepping back in with the Energy Price Guarantee to prevent the typical electricity and gas bill exceeding £2,500. It’s just part of our plan to help families this winter.”
At Autumn Statement the Chancellor announced that the EPG was due to rise to £3,000 on April 1, with the Government then expecting to borrow £12 billion to fund this support. Since then, energy prices have fallen by 50%, cutting the borrowing needed to fund energy support by two- thirds to £4 billion.
The change announced also follows the latest Ofgem Price cap of £3,280 from April to June which, in large part, sets the cost for this three-month extension. Households would pay the full Ofgem price cap rate if there was no Energy Price Guarantee.
