Rite Aid Corporation and Elixir Insurance Company Agree to Pay $101M to Resolve Allegations of Falsely Reporting Rebates

Source: United States Department of Justice Criminal Division

The Justice Department announced today that Rite Aid Corporation and Rite Aid subsidiaries, Elixir Insurance Company, RX Options LLC and RX Solutions LLC, have agreed to resolve allegations that they violated the False Claims Act (FCA) by failing to accurately report drug rebates to the Medicare Program. As part of the settlement, Elixir Insurance and Rite Aid will pay the United States $101 million, and RX Options and RX Solutions will grant the United States an allowed, unsubordinated, general unsecured claim for a total of $20 million in Rite Aid’s bankruptcy case pending in the District of New Jersey. The settlement is based on the companies’ ability to pay and was approved on June 28 by the bankruptcy court as part of Rite Aid’s plan of reorganization, which is expected to become effective later this summer. In addition to operating one of the country’s largest retail pharmacy chains, Rite Aid offered Medicare drug plans and pharmacy benefits manager (PBM) services through Elixir Insurance, RX Options and RX Solutions.  

“Participants in Medicare’s drug program must accurately report price concessions, including drug manufacturer rebates, to ensure that the government receives the benefit of those concessions,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “Today’s settlement reflects the Justice Department’s commitment to hold accountable entities that pursue their own financial interests at the expense of taxpayer programs.”

“Rite Aid and its Elixir subsidiaries lined their corporate pockets with millions of dollars of manufacturer rebates that should have been reported to Medicare,” said U.S. Attorney Rebecca C. Lutzko for the Northern District of Ohio. “Each of those dollars could have been used to benefit Americans with genuine health care needs. Our office will not tolerate deceptive health-insurance practices, and we will vigorously pursue those who violate the FCA.”

Under Medicare Part D, private entities known as Part D Plan Sponsors offer and administer insurance plans that provide prescription drug coverage to enrolled Medicare beneficiaries. Part D Sponsors must submit annual reports to the Centers for Medicare and Medicaid Services (CMS) with information about rebates and other remuneration the Plans received from drug manufacturers in connection with the Part D drugs provided to beneficiaries, which ensures that the government receives the benefit of any price concessions provided by drug manufacturers to purchasers of the drugs covered under the Part D plan. CMS relies on the reports in the annual reconciliation process that determines payments due to the Plans or CMS at the end of the year.

The settlement resolves allegations that, between 2014 and 2020, the defendants improperly reported to CMS portions of rebates received from manufacturers as bona fide service fees, even though manufacturers did not negotiate with the defendants to pay such fees. The United States further alleged that Elixir Insurance knew the retained rebates did not meet the regulatory definition of bona fide services fees.

“Truthful and accurate documentation in the delivery of health care goods or services is crucial to the integrity of federal health care programs,” said Deputy Inspector General for Investigations Christian J. Schrank of the Department of Health and Human Services Office of Inspector General (HHS-OIG). “Improper submission of manufacturer drug rebates and fees by Part D Plan Sponsors for pharmaceutical products in order to make more money will not be tolerated. Collaborating with our law enforcement partners, HHS-OIG is committed to preventing and investigating health care fraud in Medicare and other taxpayer-funded health care programs.”

The civil settlement includes the resolution of claims brought in 2021 under the qui tam, or whistleblower, provisions of the False Claims Act by Glenn Rzeszutko, who previously worked for RX Options. The FCA authorizes a private party to sue on behalf of the United States and share in any recovery. The qui tam case is captioned United States ex rel. Rzeszutko v. Rite Aid Corporation et al., No. 5:21-CV-574 (N.D. Ohio). The relator’s share of these proceeds has not yet been determined.

The Civil Division’s Commercial Litigation Branch and the U.S. Attorney’s Office for the Northern District of Ohio handled this matter, with substantial assistance from HHS-OIG and FBI Cleveland Division.

Trial attorneys Christopher Wilson and Dan Schiffer of the Civil Division’s Fraud Section and Assistant U.S. Attorney Jackson Froliklong for the Northern District of Ohio handled this matter. HHS-OIG and the FBI Cleveland Field Office provided substantial assistance in the investigation. Assistant Director Mary Schmergel and Trial Attorneys Gregory Werkheiser and Ryan Lamb of the Civil Division’s Corporate/Financial Litigation Section are handling the Rite Aid bankruptcy.

Today’s settlements illustrate 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 HHS at 800-HHS-TIPS (800-447-8477).

The claims asserted against defendants are allegations only. There has been no determination of liability.

Defense News: Navy Week Charts Course to Fargo

Source: United States Navy

Fargo Navy Week brings Sailors from across the fleet to the area to emphasize the importance of the Navy to Fargo, the state of North Dakota, and the nation.

More than 50 Sailors will participate in education and community outreach events throughout the city.

Participating Navy assets include the Virginia-class nuclear-powered attack submarine, USS North Dakota (SSN 784), Navy Band Great Lakes, USS Constitution, Naval Meteorology and Oceanography Command,  Naval History and Heritage Command, Ceremonial Guard Drill Team, Navy Talent Acquisition Group Northern Plains, Navy Reserve Center Fargo, U.S. Fleet Forces, U.S. Navy Bureau of Medicine and Surgery, Office of Small Business Programs, and Navy Esports.

The Navy’s senior executive is Adm. Stuart Munsch, Commander, U.S. Naval Forces, Europe/Commander, U.S. Naval Forces, Africa/Commander, Allied Joint Forces Command, Naples. Munsch is a native of Oakes, North Dakota and graduate of the U.S. Naval Academy in Annapolis, Maryland. Munsch assumed his current role in June 2022 as commander of Allied Joint Force Command, located in Naples, Italy. During Navy Week, he is participating in community engagements, a proclamation ceremony and engaging with local businesses, civic, education, and government leaders.

Navy Weeks are a series of outreach events coordinated by the Navy Office of Community Outreach designed to give Americans an opportunity to learn about the Navy, its people, and its importance to national security and prosperity. Since 2005, the Navy Week program has served as the Navy’s flagship outreach effort into areas of the country without a significant Navy presence, providing the public a firsthand look at why the Navy matters to cities like Fargo.

“Sailors are the reason America’s Navy is the most powerful in the world,” said NAVCO’s director, Cmdr. Julie Holland. “We are thrilled to bring your Navy Warfighters to Fargo. At Navy Weeks, Americans will connect with Sailors who have strong character, competence, and dedication to the mission, and who continue a nearly 250-year tradition of decisive power from seabed to cyberspace.”

Throughout the week, Sailors will participate in various community events and projects across the area, including engaging with youth at the YMCA summer camps, Fargo Library, Boys & Girls Clubs of the Red River Valley, volunteering with Habitat for Humanity, the Salvation Army, Great Plains Food Bank, 4 Luv of Dog Rescue, amongst many others. They’ll also participate in a Red River Cleanup and sled hockey competition with Hope Inc. The Navy Band Great Lakes has free scheduled performances at the Fargo Airsho opening ceremony, Red River Valley Zoo, Red River Market and other venues throughout the week.

Mayor Tim Mahoney, The City of Fargo and leadership from surrounding communities will hold a Proclamation Ceremony, at 8:30 a.m. on Thursday, July 25, in the Commission Chambers at Fargo City Hall. Admiral Stuart Munsch will accept the Proclamation, Sailors from the USS North Dakota (SSN 784), will attend, and the Navy Band Great Lakes Brass Ambassadors and Ceremonial Guard will perform.

Fargo Navy Week is one of 15 Navy Weeks in 2024, which brings a variety of assets, equipment, and personnel to a single city for a weeklong series of engagements designed to bring America’s Navy closer to the people it protects. Each year, the program reaches more than 130 million people — about half the U.S. population.

Media organizations wishing to cover Fargo Navy Week events should contact Lt. Cmdr. Jill Brown at (214) 402-4444 or jill.m.brown2.mil@us.navy.mil

Defense News: New ONR Global Technical Director

Source: United States Navy

The Office of Naval Research (ONR) Global has promoted Dr. Marcus Tepaske to the role of Technical Director, where he will lead experts in finding cutting-edge technologies and solutions and getting them into the hands of Sailors and Marines.

Tepaske, who officially started in his new position on July 1, previously served as an ONR Global science director in Singapore from 2022 to 2024.

“Dr. Tepaske brings a wealth of experience and expertise in fostering international research collaborations in emerging science and technology for our future fleet and force,” said ONR Global Commanding Officer Capt. Andy Berner. “With a strong background working at ONR, and a long history of building productive partnerships, he is poised to make even more significant contributions to our mission.”

ONR Global provides worldwide science and technology (S&T)-based solutions for current and future naval challenges. The command reaches out to the broad global technical community and the operational fleet to cultivate cooperation in areas of mutual interest and to bring the full range of possibilities to the Navy and Marine Corps.

Tepaske will lead more than 50 scientists, technologists and engineers with a physical presence on five continents, and bridge the gap between emerging science and technology and warfighters at home and abroad.

Tepaske’s prior tenure at ONR Global includes rotations as the director of Experimentation and Analysis, as well as science advisor to U.S. Fleet Forces Command, Marine Corps Forces Command and II Marine Expeditionary Force. During those assignments, he made significant contributions to the ONR Global mission, including deployments to Afghanistan and aboard the USS BUSH CVN in support of naval science and technology.

Tepaske has extensive experience in both Navy and Marine Corps weapons system integration through his work as the ONR Fires Thruster deputy program manager and as the deputy program manager for the Navy’s Patrol Coastal Griffin Missile System.

Previously, Tepaske spent 10 years at Naval Surface Warfare Center Dahlgren Division, working on a broad spectrum of technology development programs, some of which deployed in support of Operation Iraqi Freedom and Operation Enduring Freedom.

Tepaske earned a Bachelor’s of Science in mechanical engineering from Virginia Polytechnic and State University, and a Master’s of Engineering Management and Doctorate of Engineering from Old Dominion University.

Cherish T. Gilmore is a contractor for ONR Corporate Strategic Communications.

Court Enjoins Louisiana Company and its Owners from Distributing Adulterated Food

Source: United States Department of Justice Criminal Division

On July 2, a federal court enjoined a Louisiana company from manufacturing and distributing adulterated food products in violation of the Federal Food, Drug and Cosmetic Act (FDCA).

In a civil complaint filed on June 10, the United States alleged that Freshy Foods, LLC, Team Fresh & Go, LLC and its owners, Floyd D. James and Ida M. James, violated the FDCA at their food processing facility in Elmwood, Louisiana by manufacturing and distributing adulterated food products. The defendants manufactured and distributed ready-to-eat food products, including sandwiches and fruit cups. The complaint alleged that environmental tests in 2023 detected Listeria monocytogenes (L. mono), the pathogen that can cause listeriosis, in the defendants’ facility. The complaint also alleged that a 2023 U.S. Food and Drug Administration (FDA) inspection identified insanitary conditions at the facility. According to the complaint, the defendants voluntarily withdrew their registration to process FDA-regulated food in August 2023.

“Food manufacturers must ensure the safety of their food products,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Justice Department works closely with the FDA to pursue appropriate legal actions against food manufacturers who fail to adhere to laws designed to protect public health.”

“The FDA will continue to stress that it’s the responsibility of food manufacturers to ensure they are producing food under safe and sanitary conditions,” said Deputy Commissioner Jim Jones for Human Foods at the FDA. “When a company consistently fails to demonstrate that they are capable of upholding their legal responsibilities, the FDA will seek to hold them accountable.”

The defendants filed an answer denying the government’s allegations, but also agreed to settle the suit by entering into a consent decree. The order entered by the court permanently enjoins the defendants from violating the FDCA. The consent decree also requires, subject to limited exceptions, that the defendants notify FDA and comply with specific remedial measures prior to resuming the manufacture of any FDA-regulated food products.

Trial Attorneys Colin W. Trundle and Kathryn A. Schmidt of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Sandra Lee Sears for the Eastern District of Louisiana handled the case, with assistance from Assistant Chief Counsel Sarah Rosenberg of FDA’s Office of the Chief Counsel.

Additional information about the Consumer Protection Branch and its enforcement efforts can be found at www.justice.gov/civil/consumer-protection-branch.

The claims resolved by the consent decree announced today are allegations only, and there has been no determination of liability.

Defense News: USS John C. Stennis Leaves Dry Dock, Begins Second Phase of Refueling and Complex Overhaul

Source: United States Navy

Commissioned in December 1995, the nation’s seventh Nimitz-class nuclear-powered aircraft carrier entered RCOH in May 2021, under a $3 billion contract with NNS. The overhaul is now more than 65 percent complete and tracking for redelivery in October 2026.

Aircraft carriers enter refueling complex overhauls at the mid-point of their 50-plus-year lifespan, incorporating upgrades to propulsion equipment, infrastructure and electronic systems. After NNS flooded the dry dock with more than 100 million gallons of water, the ship moved to the shipyard’s outfitting berth, where shipyard workers and crew will complete the installation and testing of major components and combat support systems.

Rear Adm. Casey J. Moton, Commander, Program Executive Office Aircraft Carriers, recognized the important milestone, adding that the next phase of the ship’s overhaul will deliver impressive new technologies to support the Navy’s warfighters, enabling John C. Stennis to meet operational taskings during another 25-plus years of service.
“When John C. Stennis redelivers, she’ll be the most technologically advanced Nimitz-class aircraft carrier in the Navy,” Moton said. “She’ll bring to the fleet the highest level of capability across all mission sets.”

Moton also acknowledged that the shipyard and Navy team have been navigating several challenges and working under an extended redelivery schedule due both to mandatory growth work following ship condition assessments, as well as industrial base challenges.

“The Navy-Industry team is dealing with the lingering effects of a post-COVID industrial base—one that includes a reduced or unstable capability and capacity along with challenges in workforce recruitment, retention and proficiency. However, the bottom line is that fleet operators need us to deliver these capital assets to our warfighters ready for tasking, so we are working on a daily basis with our industry partners and within the Navy to accelerate problem solving and to speed production on the deck plates—all focused on delivering readiness. I am proud of our entire team for achieving this important production milestone towards redelivering USS John C. Stennis to the fleet.”

Capt. Mark Johnson, manager of the PEO Aircraft Carriers In-Service Aircraft Carrier Program Office, said that the Navy-Industry team is leveraging lessons learned from the Navy’s previous RCOHs, especially on USS George Washington (CVN 73), which was redelivered in May 2023.

“Recognizing the changing workforce demographics coming out of the COVID pandemic, the combined Navy/Shipbuilder team has taken measurable steps to improve the level of support to the mechanic or sailor actually performing work on the ship by leveraging new digital management tools and processes,” said Johnson.

More than 25 million total man-hours of work will go into John C. Stennis’ RCOH, with crews refitting and installing a new square and tapered mast, accommodating state-of-the-art defense and communications systems, updates to the ship’s shafts, refurbished propellers, and modernized aircraft launch and recovery equipment.

“RCOH construction enhances nearly every space and system on the carrier, beyond the most critical requirement to defuel and refuel the ship’s two nuclear reactors and to repair and upgrade the propulsion plant,” Johnson said. “We work on every part of the ship, from the hull, screws and rudders to more than 600 tanks; thousands of valves, pumps and piping components; electrical cables and ventilation; as well as combat and aviation support systems. It’s demanding, complex work that challenges every member of the planning team, shipyard crews and ship’s force.”

During the upcoming outfitting and testing phase, shipbuilders will complete the overhaul and installation of the ship’s major components and test its electronics, combat and propulsion systems. This period will also focus on improving the ship’s living areas and the general quality of life for the sailors, including crew living spaces, galleys and mess decks.

From Program Executive Office Aircraft Carriers Public Affairs.