Security News: Philips Subsidiary to Pay Over $24 Million for Alleged False Claims Caused by Respironics for Respiratory-Related Medical Equipment

Source: United States Department of Justice News

Philips RS North America LLC, formerly known as Respironics Inc., a manufacturer of durable medical equipment (DME) based in Pittsburgh, Pennsylvania, has agreed to pay over $24 million to resolve False Claims Act allegations that it misled federal health care programs by paying kickbacks to DME suppliers. The affected programs were Medicare, Medicaid and TRICARE, which is the health care program for active military and their families.

The settlement resolves allegations that Respironics caused DME suppliers to submit claims for ventilators, oxygen concentrators, CPAP and BiPAP machines, and other respiratory-related medical equipment that were false because Respironics provided illegal inducements to the DME suppliers. Respironics allegedly gave the DME suppliers physician prescribing data free of charge that could assist their marketing efforts to physicians.    

“Paying illegal remuneration to induce patient referrals undermines the integrity of our nation’s health care system,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “To ensure that the goods and services received by federal health care program patients are determined by their health care needs, rather than the financial interests of third parties, we will pursue any individual or entity that violates the prohibition on paying kickbacks, including DME manufacturers.”

“The people of South Carolina need to know that medical facts — not finances — drive their health care decisions,” said U.S. Attorney Adair F. Boroughs for the District of South Carolina. “Those who improperly use money and other things of value to induce business in violation of the Anti-Kickback Statute will be held accountable.”

“Paying kickbacks to medical equipment providers is misaligned with patient care and corrupts our nation’s health care programs including TRICARE,” said Special Agent in Charge Christopher Dillard for the Department of Defense Office of Inspector General, Defense Criminal Investigative Service (DCIS), Mid-Atlantic Field Office. “Working closely with our law enforcement partners, DCIS will continue to investigate those who risk harming the welfare of our active-duty service members and seek to profit at the expense of the American taxpayer.”

“By paying kickbacks to obtain patient referrals, DME manufacturers are prioritizing financial incentives over patient needs, which undermines the integrity of federal health care programs,” said Special Agent in Charge Tamala E. Miles for the Department of Health and Human Services, Office of the Inspector General (HHS-OIG). “HHS-OIG will continue to work tirelessly with our law enforcement partners to prevent such waste of valuable taxpayer dollars.”

The Anti-Kickback Statute prohibits the knowing and willful payment of any remuneration to induce the referral of services or items that are paid for by a federal health care program, such as Medicare, Medicaid or TRICARE. Claims submitted to these programs in violation of the Anti-Kickback Statute give rise to liability under the False Claims Act.

The settlement provides that Respironics will pay $22.62 million to the United States, and in addition, will pay $2.13 million to the various states as a result of the impact of Respironics’ conduct on their Medicaid programs, pursuant to the terms of separate settlement agreements that Respironics has, or will enter into, with those states.

In addition to the civil settlement, Respironics entered into a five-year Corporate Integrity Agreement (CIA) with HHS-OIG. The CIA requires Respironics to implement and maintain a robust compliance program that includes, among other things, review of arrangements with referral sources and monitoring of Respironics’ sales force. The CIA also requires Respironics to retain an independent monitor, selected by the OIG, to assess the effectiveness of Respironics’ compliance systems.

The settlement resolves a lawsuit originally brought by Jeremy Orling, a Respironics’ employee, under the qui tam or whistleblower provisions of the False Claims Act. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. As part of this resolution, Orling will receive approximately $4.3 million of the federal settlement amount.

This settlement was the result of a coordinated effort by the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section and the U.S. Attorney’s Office for the District of South Carolina with assistance from the HHS-OIG and HHS Office of Investigations; DCIS; the Defense Health Agency Office of General Counsel; and the National Association of Medicaid Fraud Control Units.  

The investigation and resolution of this matter illustrates the government’s emphasis on combating health care fraud. One of the most powerful tools in this effort is the False Claims Act. 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).

The matter was handled by Senior Trial Counsel Daniel A. Spiro of the Fraud Section of the Civil Division and Assistant U.S. Attorneys Beth Warren and Johanna Valenzuela District of South Carolina.

The lawsuit resolved by this settlement is captioned United States, et al., ex rel. Respiratory Care., LLC v. Respironics, Inc., et al., Case No. 2:19-cv-02913-BHH (D.S.C).  The claims resolved by the settlement are allegations only, and there has been no determination of liability. 

Defense News: DLA Energy extends utility services partnership with U.S. Navy

Source: United States Navy

DLA Energy Utility Services provides pre- and post-award contracting and technical expertise for Service partners who want to transfer ownership, operations and maintenance of installation utility systems to a contracted system owner.

Since 1999, DLA Energy Utility Services has managed the utility services contracting mission for the Army and the Air Force, adding the Navy initially in 2019. As of August 2022, DLA Energy has awarded 101 new and continued utilities privatization contracts for 172 systems at 71 installations. 

“The Navy had been doing its own utilities privatization procurements from cradle to grave,” said Laurie Carlson, Deputy Division Chief of DLA Energy Utility Services. “They approached us in 2018 to establish an agreement for a three-year pilot program because they lost the historical utilities privatization experience in their contracting shop, and they knew we were the center of excellence for the Army and Air Force programs.”

In June 2022, DLA Energy in coordination with Naval Facilities Engineering Systems Command awarded a contract to privatize the wastewater utility system for Naval Station Mayport, Florida. According to a Navy press release, the contract will upgrade the system and comply with National Pollutant Discharge Elimination System and Clean Water Act regulations, while realizing a cost avoidance of approximately $65 million over the life of the contract.

The Navy and DLA Energy are planning on two more awards in fiscal 2023. 

“Over the past few years, the Navy witnessed our unique capabilities, industry partnerships and expert contracting workforce and decided to make the agreement more permanent extending the partnership through June 2028,” Carlson said. 

Utilities privatization began in the 1990s to help military installations obtain safe, reliable, technologically current, and environmentally sound utility systems at a relatively lower cost than under government ownership. In the privatization process, military installations shift from the role of owner- operators to that of smart utility service customers. 

“Most installations were built many decades ago and many of the utility systems are old and deteriorating,” Carlson said. “Utility services contracts leverage the experts to recapitalize systems and achieve resilient and reliable utilities.”

One distinct advantage of a utilities privatization contract is the Services’ costs for operations, maintenance, renewals and replacements of the system are amortized over 50 years, she said. 

“The contracted system owner ensures the system is maintained and complies with current codes, standards, and best practices,” said Ken Richardson, DLA Energy Utility Services Navy Program Manager. “The installation now has a partner it can work with to quickly adapt when change is needed, such as technology advancements or changing environmental or safety requirements. It’s a long-term solution to a very real problem.”

DLA Energy has earned a strong reputation with both utility companies and the customer because of its consistent, reliable and efficient processes for awarding contracts, Carlson said.

About eight years ago, Carlson led a deep dive examination of DLA Energy Utility Services’ contracting processes. The team set milestones and outlined the procurement steps within each milestone looking for ways to improve, expedite or condense the processes. 

“Because of the streamlined processes, we’ve been able to successfully award a number of procurements on time and get results,” Richardson said. “Mayport is a really good example of that. We set a timeline in our acquisition plan that we agreed to with the Navy, and we held to it. We were able to executive it on time and deliver results.”

DLA Energy Utility Services plans to continue growing its partnerships and helping military and federal customers increase energy reliability, security and resilience.

A video about DLA Energy’s utilities privatization efforts on Fort Hood, Texas, highlights the installation’s successes in the program. Read more about other utilities privatization projects in the DLA Newsroom

Learn more about DLA Energy Utility Services and other DLA Energy programs and services at www.DLA.mil/Energy

Defense News: U.S. Maritime Forces Arrive for UNITAS LXIII hosted by Brazil

Source: United States Navy

This year’s exercise is hosted by the Brazilian Navy and will included 20 participating nations, 19 ships, one submarine, 21 aircraft, accounting for approximately 5,500 total military personnel that will conduct operations principally off the coast of Rio de Janerio.

UNITAS, which is Latin for “unity,” was conceived in 1959 and has taken place annually since first conducted in 1960. This year marks the 63rd iteration. This year, Brazil will host UNITAS in conjunction and celebration of the bicentennial anniversary of both their nation’s independence and navy’s founding.

“This exercise is an incredible opportunity for all participating nations to come together as professional mariners on the sea, under the sea, in the air and in the littorals, to operate and grow as a team in order to strengthen our partnerships and enhance our collective maritime posture,” said Rear Admiral Jim Aiken, commander U.S. Naval Forces Southern Command/U.S. 4th Fleet. “Congratulations to Brazil on 200 years of independence and excellence in the maritime domain on the sea and on the land.”

In addition to the United States, UNITAS LXIII will bring together 19 nations from across Central and South Americas, the Caribbean, Europe, and Africa to train forces in joint maritime operations that enhance tactical proficiency and increase interoperability. Participating nations include Belize, Brazil, Cameroon, Chile, Colombia, Dominican Republic, Ecuador, France, Guyana, Jamaica, Mexico, Namibia, Panama, Paraguay, Peru, South Korea, Spain, United Kingdom, and Uruguay.

“Exercise UNITAS is a highly anticipated premier training opportunity for all the participating nations’ navies and marine corps in the Western Hemisphere,” said Lt. Gen. David Bellon, commander of U.S. Marine Corps Forces, South and Marine Forces Reserve. “UNITAS highlights the foundation of our partnerships and our dedication to building and sustaining the social and military relationships necessary to achieve common objectives and regional security.” 

The initial in-port phase will include cultural exchanges, sporting events, community relations projects and the opportunity for UNITAS LXIII partners to participate in bicentennial events such as the Bicentennial Naval Parade scheduled for Sept. 7 along the coast of Rio de Janeiro.
 
Following opening ceremonies on Sept. 8, naval forces will conduct combined and joint operations as a multi-national task force, executing an event-driven scenario to train in multiple warfare areas. Ships and sailors will head to sea for maritime operation training and Marines will move inland to conduct amphibious training ranges before coming back together in support of a culminating multinational amphibious landing.
 
A significant focus of UNITAS LXIII is the cooperation and integration of the multinational navy forces with marine corps and naval infantries. The maritime domain includes the littorals that incorporates the ocean and the area inland from the shore which can be supported and defended directly from the sea.

U.S. forces participating in UNITAS LXIII include USS Lassen (DDG 82), USS Mesa Verde (LPD 19), USS Albany (SSN 753), Commander, Amphibious Squadron Eight (COMPHIBRON 8), Helicopter Sea Combat Squadron 22 (HSC 22), Helicopter Maritime Strike Squadron 70 Detachment 2 (HSM 70 Det 2), Patrol Squadron Sixteen (VP-16), Special Boat Team 22 (SBT 22), Mobile Diving and Salvage Unit (MDSU) Det 2, Seal Platoon from Seal Team 8, Explosive Ordnance Disposal Mobile Unit Two (EODMU-2), Beachmaster Unit Two (BMU-2), USCG Pacific Area Tactical Law Enforcement Team (PAC AREA TACLET), Commander, Destroyer Squadron 40, (COMDESRON 40), Fleet Surgical Team (FST) 8, 25th Marine Regiment, 3d Battalion 25th Marine Regiment, 3d Force Reconnaissance Company, 4th Light Armored Reconnaissance Company (4th LAR), 4th Combat Engineer Battalion (4th CEB), 6th Engineer Support Battalion (6th ESB), 4th Air Naval Gunfire Liaison Company (ANGLICO), 4th Civil Affairs Group (4th CAG), Marine Aircraft Group 49 (MAG-49), U.S Marine Corps Forces South (MARFORSOUTH), and USNAVSO/FOURTHFLT.

U.S. Naval Forces Southern Command/U.S. 4th Fleet supports U.S. Southern Command’s joint and combined military operations by employing maritime forces in cooperative maritime security operations to maintain access, enhance interoperability, and build enduring partnerships in order to enhance regional security and promote peace, stability and prosperity in the Caribbean, Central and South American region.

U.S. Marine Corps Forces, South is the Marine Corps component to U.S. Southern Command, is responsible for planning exercises, operation, and overall Marine Corps support for the SOUTHCOM assigned area of responsibility.

Security News: Rockford Man Sentenced to More than Five Years in Federal Prison for Illegally Possessing Firearm “Switch” Devices

Source: United States Department of Justice News

ROCKFORD — A Rockford man has been sentenced to five and a half years in federal prison for illegally possessing firearm “switch” devices.

JAVAUGHN A. HIXSON, 23, possessed and sold four of the devices, also known as “Glock switches,” in Rockford from October to December of 2020.  Each conversion device is designed and intended to convert a firearm into a machine gun capable of automatically firing more than one shot with a single pull of the trigger. 

Hixson also illegally possessed a loaded handgun with an extended magazine.  On Jan. 4, 2021, Hixson was a passenger in a vehicle that was stopped by the Rockford Police Department.  Hixson ran from the officers and tossed the gun into the snow.  Hixson had previously been convicted of a felony weapons offense and was prohibited by federal law from possessing a firearm.

Hixson pleaded guilty earlier this year to one count of illegally possessing machine guns and one count of illegally possessing the firearm. 

U.S. District Judge Iain D. Johnston imposed the 66-month prison sentence on Aug. 25, 2022, after a hearing in federal court in Rockford.  In a written sentencing order, Judge Johnston stated, “The sole and exclusive purpose of Glock switches, which are easily manufactured, is to convert an already dangerous firearm into an extremely dangerous machinegun.  The dangerousness manifests itself not only in the sheer number of bullets that can be emptied from the magazine in the blink of an eye but also in the resulting lack of control of the firearm when discharging it.  The damage a machinegun can inflict is enormous.  The damage — intended and unintended — a handheld machinegun can inflict is just as great.  This offense involved 9 Glock switches, some of which Mr. Hixson sold believing they would be resold to others.”

The sentence was announced by John R. Lausch, Jr., United States Attorney for the Northern District of Illinois; Kristen de Tineo, Special Agent-in-Charge of the Chicago Field Division of the U.S. Bureau of Alcohol, Tobacco, Firearms & Explosives; Gary Caruana, Winnebago County Sheriff; and Carla Redd, Chief of the Rockford Police Department.  The government was represented by Assistant U.S. Attorney Talia Bucci.

Holding illegal firearm possessors accountable through federal prosecution is a centerpiece of Project Safe Neighborhoods (PSN) – the Department of Justice’s violent crime reduction strategy.  In the Northern District of Illinois, U.S. Attorney Lausch and law enforcement partners have deployed PSN program to attack a broad range of violent crime issues facing the district, particularly firearm offenses.

Security News: Justice Department Secures Settlement Agreement with the Indiana State Nursing Board Addressing Discrimination Against People with Opioid Use Disorder

Source: United States Department of Justice News

The Justice Department announced today that it has entered into a settlement agreement with the Indiana State Board of Nursing (Nursing Board) to resolve claims it violated Title II of the Americans with Disabilities Act (ADA). The settlement agreement ensures that nurses who take medication to treat opioid use disorder (OUD) can remain on their medication when participating in the Indiana State Nursing Assistance Program. The program assists in rehabilitating and monitoring nurses with substance use disorders, and is often required for these nurses to maintain an active license or have one reinstated. The department previously notified the Nursing Board of its findings, and described the remedial measures necessary for the Nursing Board to address the ADA violation identified. This case was handled jointly by the Disability Rights Section of the Civil Rights Division and the U.S. Attorney’s Office for the Southern District of Indiana.

“Indiana may not deny individuals life-saving medications, including medications that treat opioid use disorder, based on stereotypes and misinformation,” said Assistant Attorney General Kristen Clarke of the Justice Department’s Civil Rights Division. “Requiring nurses to stop taking prescribed medication as a condition of maintaining a nursing license violates the ADA, and not only creates barriers to recovery, but inappropriately limits employment opportunities based on disability.”

“The opioid epidemic has greatly impacted professionals and families of all walks of life, and Indiana nurses have the right to seek medically approved treatment for opioid use disorder under federal law,” said U.S. Attorney Zachary A. Myers for the Southern District of Indiana. “Following the Justice Department’s findings and the parties’ settlement agreement, Indiana must now enact policies to ensure that Hoosier nurses will not be forced to choose between their recovery and their livelihoods.”

Under the terms of the agreement, the Nursing Board will allow nurses to participate in the states’ rehabilitation program while taking medication, including medication to treat OUD, when the medication is prescribed by a licensed practitioner as part of a medically necessary treatment plan and incorporated into a recovery monitoring agreement. In addition, the Nursing Board has agreed to revise its written polices to ensure that nurses taking prescribed medications for OUD are not subjected to discriminatory conditions or terms. The Nursing Board has also agreed to pay a total of $70,000 in damages to the complainant, and to report periodically on its compliance to the United States.

Methadone and buprenorphine (including brand names Subutex and Suboxone) are approved by the Food and Drug Administration to treat OUD. According to the U.S. National Institute on Drug Abuse (NIDA), methadone and buprenorphine help diminish the effects of physical dependency on opioids. When taken as prescribed, these medications are safe and effective.

The Civil Rights Division, together with U.S. Attorneys’ offices, has been working to remove discriminatory barriers to recovery for individuals who have completed, or are participating in, treatment for OUD. Through outreach, technical assistance and enforcement under the ADA, the Civil Rights Division seeks to ensure that those in treatment or recovery can successfully participate in their communities and the workforce. For example:

  • On April 5, 2022, the department issued guidance on protections for people with OUD under the ADA.
  • On March 24, 2022, the department entered into a settlement agreement with the Massachusetts Trial Court to resolve allegations that its drug court violated the ADA by discriminating against individuals with OUD.
  • On March 17, 2022, the department entered into a settlement agreement with Ready to Work, a Colorado-based employment, residential and social services program for individuals experiencing homelessness, resolving allegations that the program denied admission to an individual because she takes medication for OUD.
  • On Feb. 24, 2022, the department filed a lawsuit against the Unified Judicial System of Pennsylvania, alleging that it prohibits or otherwise limits participants in its court supervision programs from using medication to treat OUD.

For more information on the ADA, please call the department’s toll-free ADA information line at 1-800-514-0301 (TDD 800-514-0383) or visit www.ada.gov. For more information on the Civil Rights Division, please visit www.justice.gov/crt. Complaints about disability-based discrimination may be reported to the Civil Rights Division through the internet reporting portal at https://civilrights.justice.gov/.