Medical Device Company to Pay $700,000 to Resolve False Claims Act Allegations Concerning Inflated Reimbursements from Medicare and Medicaid

Source: United States Department of Justice Criminal Division

Medical device manufacturer THD America Inc., located in Natick, Massachusetts, and its corporate parent, THD SpA of Italy (collectively, THD), have agreed to pay $700,000 to resolve allegations that THD violated the False Claims Act by knowingly causing physicians to use incorrect codes to obtain inflated reimbursement from Medicare and State Medicaid programs for the use of THD’s hemorrhoid removal system called the Slide One Kit (the Kit).

The Kit was sold to physicians for use in transanal hemorrhoidal dearterialization, a surgical procedure that involves cauterizing certain blood vessels. The United States alleged that, between 2014 and 2017, physicians performing procedures using the Kit were required to bill for the procedure using a temporary code, also known as a “T-Code,” assigned for new and emerging services. Because a procedure that is assigned such a code is considered experimental, reimbursement for the use of the Kit was often denied. To avoid such denials and increase potential reimbursement, THD allegedly encouraged colorectal and general surgeons improperly to bill Medicare and Medicaid programs using the T-Code plus an additional Current Procedural Terminology (CPT) code or to bill for CPT codes other than the T-code.

The federal share of the civil settlement is $598,121.23, and the state Medicaid share of the civil settlement is $101,877.77. State Medicaid programs are jointly funded by the federal and state governments.

“The integrity of federal healthcare programs depends upon compliance with coding and billing rules that are used to make coverage and reimbursement decisions,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “We will hold accountable health care providers that knowingly submit false claims to federal health care programs that do not accurately reflect and bill for the work they perform.”

“This case is emblematic of the U.S. Attorney’s Office’s commitment to pursuing and holding accountable those who seek to defraud federal health care programs and to recouping taxpayer dollars obtained falsely,” said U.S. Attorney Erek L. Barron for the District of Maryland. “We will continue our efforts tirelessly in prioritizing rooting out fraud and protecting the public fisc.”

“Accurately billing for services provided to Medicare and Medicaid enrollees is required of all health care companies,” said Special Agent in Charge Maureen Dixon of the Department of Health and Human Services Office of the Inspector General (HHS-OIG). “HHS-OIG will continue to work with the U.S. Attorney’s Office and our law enforcement partners to investigate allegations of companies violating the federal False Claims Act.”

The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by Amber Arthur, a former employee of THD America. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. The relator’s share from the proceeds of the settlement will be $115,500. The qui tam action is captioned U.S. ex rel. Arthur v. THD America, et al., No. 16-cv-2571 (DMD). 

The resolution obtained in this matter was the result of a coordinated effort between the U.S. Attorney’s Office for the District of Maryland and the Civil Division’s Commercial Litigation Branch, Fraud Section, with assistance from HHS-OIG.

The investigation and resolution of this matter illustrates the government’s emphasis on combating healthcare 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 HHS at 800-HHS-TIPS (800-447-8477).

Assistant U.S. Attorney Tarra DeShields for the District of Maryland and Senior Trial Counsel Jay D. Majors of the Justice Department’s Civil Division handled the matter.

The claims resolved by the settlement are allegations only. There has been no determination of liability.

Defense News: Restoring the Shores: Dune Restoration Project Underway at Naval Station Mayport

Source: United States Navy

General Mechanical Corporation (GMC) from Daytona Beach, Florida, has embarked on an ambitious $10.6 million construction contract to restore the storm-battered dunes at Naval Station (NAVSTA) Mayport. Awarded by Naval Facilities Engineering Systems Command (NAVFAC) Southeast in September 2023, the contract sets a new course for the restoration of coastal defenses that were ravaged by Hurricanes Ian and Nicole, as well as ongoing tidal erosion.

By early July, sand mining operations were underway. The first major task was to extract and prepare the large quantity of sand needed for the project. The goal is to restore the dunes to a height of 12-14 feet, which is crucial for shielding the base from future storm surges.

“A key element to this project is to ensure the habitat protection of native animals that live or nest in the dunes,” said Benjamin Yang, construction manager assigned to Public Works Department at NAVSTA Mayport. “The team has maintained a vigilant watch over a Loggerhead turtle nest, waiting for the hatchlings to make their way to the sea before proceeding with work in that area.”

Orange barriers were erected to mark and protect any vulnerable nests that could be affected by the ongoing dune project.

The project also includes replacing the fencing between the base and the adjoining civilian park and beach at Kathryn Abbey Hanna Park (Hanna Park), establishing a much-needed security buffer. Additionally, storm-damaged facilities, such as boardwalks, will be repaired.

By mid-August, GMC had already made significant progress. Of the 64,000 cubic yards of sand needed, nearly 40,000 cubic yards had been mined, with 8,000 cubic yards screened and 9,000 cubic yards transported and placed on the dunes.

Sand was extracted from a designated dredge material management area within NAVSTA Mayport. A Powerscreen sorts raw ground materials and reduces them to usable aggregate sizes, which are then used to build up the dunes.

“We’re screening between 1,000 and 1,200 cubic yards of sand and transporting around 100 truckloads — about 1,400 cubic yards — a day to the beach,” said Dillon Moyer, superintendent, Continental Heavy Civil Corporation (CHC). “The initial completion target is March 2025, but with our current pace, we’re aiming to wrap up by December 29, weather and equipment permitting.”

Just south of NAVSTA Mayport, the U.S. Army Corps of Engineers (USACE) is working to restore dunes at Hanna Park and moving northward toward the base. Their efforts complement GMC’s work, with plans to transition seamlessly to NAVSTA Mayport’s beach upon completing the Hanna Park project. Once the transition to NAVSTA Mayport begins, USACE will operate around the clock for about a month to achieve their milestones at the base.

The synchronized efforts of GMC, CHC, and USACE are a testament to the collaborative spirit needed to restore and fortify the dunes and security at NAVSTA Mayport. With each passing day, the sandy beaches are being reshaped, not just as a defense against future storms but as a promise to protect and preserve the natural habitat for generations to come.

NAVFAC Southeast oversees the planning, designing, and construction of facility projects, and provides essential services in contracting, leasing, environmental management, maintenance, and contingency support. These services are vital for meeting the needs of the Navy and the Department of Defense within the Southeast region. Operating from its Jacksonville office, NAVFAC Southeast manages operations across Navy installations from Charleston, South Carolina, to Corpus Christi, Texas, and extends to Guantanamo Bay, Cuba. NAVFAC professionals also handle the acquisition and disposition of real estate, facility management, and maintenance on all Navy bases in the Southeast region, while overseeing public-private venture (PPV) housing for military families.

Defense News: NMLPDC Holds Global Military Tropical Medicine Course

Source: United States Navy

During July 2024, Naval Medical Leader and Professional Development Command (NMLPDC) held the annual 4-week in-person Military Tropical Medicine (MTM) didactic course for 43 students at the Uniformed Services University of Health Sciences. The didactic phase of the course was immediately followed by a 2-week hands-on field experience for 92 students throughout eight tropical infectious disease endemic locations around the globe during August 2024.

The MTM course, offered as in-person and online, provides tri-service military medical providers with didactic content and hands-on field experiences to diagnose, treat and prevent infectious diseases to protect the Joint Force against tropical endemic health threats and provide healthcare to partner nations during global health engagement missions.

“We often don’t receive this content in medical school or graduate medical education programs,” said Capt. Todd Gleason, MC, USN, MTM course director. “Our student body is [tri-service] nurses, physicians, lab technicians, pathology residents and aerospace medicine residents and we are able to discuss the power that we bring to the team.”

Select students who completed the MTM course (in-person or online) had a follow-on opportunity to engage with host nation military medical ships, hospitals, laboratories, and various healthcare professionals during 2-week field experiences in Brazil, Thailand, Liberia, Peru, Ghana, India, Honduras, and Tanzania to apply knowledge gained in the classroom to work on the ground in austere tropical environments.

Capt. Katie Shobe, MSC, USN, NMLPDC Commanding Officer, had an opportunity to visit one of the field training sites. “I participated in the mission to Peru, where we conducted several exercises in Lima and Tumbes, including cultural familiarization, visiting the Lima Peruvian Naval Hospital (Centro Medico Naval, or CEMENA) and their patients, Naval Medical Research Unit-SOUTH to learn about their mission and projects in the AOR, learning to conduct surveillance with mosquitoes, cysticercosis in pigs, small mammal trapping and baiting, and rodent necropsy. “

In addition to the classroom and field experiences, Capt. Gleeson and his fellow MTM course team members, LCDR Tupur Husain, MSC, USN, HM1 Danielle Spivey, USN, HM1 Michael Boateng, and HM1 Jayden Ryan, USN administered an online asynchronous MTM course from August 2023 to June 2024 for 287 students, which greatly expanded course access to military medical providers who cannot attend the in-person option.

“I came away with profound gratitude and appreciation for what our NMLPDC MTM team does, including coordinating with our partner organizations in the 8 OCONUS locations,” said Shobe. “An immense amount of work goes into the 4 weeks of coursework and labs. Bravo Zulu to the MTM Team!”

Continuing on the momentum of the highly successful in-person, virtual, and field exercises this year, the MTM staff will hold the following upcoming course options over the next year for tri-service medical providers: Online-Asynchronous course (September 2024 to June 2025), in-person course (July 7 to August 1, 2025 in Bethesda, MD), and field missions (1 August to 17 August, 2025) in Ghana, Brazil, India, Peru, Liberia, Honduras, Tanzania, and Thailand.

Interested tri-service medical providers can visit the CAC enabled NMLPDC course site for additional MTM course information at:

https://obiwan2.health.mil/sites/nmfsc/apps/ACR/SitePages/courseInfo.aspx or via email:

usn.bethesda.navmedleadprodevcmd.list.nmlpdc-mtm@health.mil

Naval Medical Leader and Professional Development Command (NMLPDC) is the cornerstone of Navy Medicine’s leader and professional development supporting Force Generation and Development of the Naval and Joint Forces. NMLPDC is a tenant command located at Naval Support Activity, Bethesda, MD.

Deputy Attorney General Lisa Monaco Delivers Remarks on Combating the Production of Unlawful Machinegun Conversion Devices

Source: United States Department of Justice Criminal Division

Remarks as Prepared for Delivery

Thank you, Director Dettelbach, for that kind introduction.  

Before I begin, I want to echo the Director and express my sympathies to the families and loved ones impacted by Wednesday’s horrific school shooting in Georgia. The Department stands with all law enforcement and community members responding to this tragedy.

Now, turning to our mission today.

I’m grateful to Director Dettelbach, and the leadership and vision from the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), in gathering the group around this table — folks from law enforcement, academia, and the private sector — coming together to tackle the spread of machine gun conversion devices and the violence they leave in their wake.

I also want to extend a special welcome and thank you to our partners from Dartmouth College, Wichita State University, Oak Ridge National Lab, and representatives from the 3-D printing industry for coming together to address the abuse and misuse of technology to accelerate violence in our communities.

Thank you for your engagement over the last year as we work together to identify ways to get these deadly devices off our streets.

The Department of Justice has no higher priority than keeping our communities safe.

We’ve been all-in on reversing the violent crime uptick that started during the pandemic in 2020 — an uptick defined by an increase in gun crimes in too many communities. 

Gun crimes made more violent and more deadly by machine gun conversion devices.

Since 2021, the Justice Department has been executing a comprehensive strategy to reduce violent crime — one rooted in local communities and built on four pillars:

  1. Going after the most significant drivers of violent crime — like gun crimes, dangerous weaponry, and violent repeat offenders;
  2. Fostering trust and earning legitimacy in the communities we serve;
  3. Investing in community-based prevention and intervention programs; and
  4. Measuring the results of our efforts by impact, through actual decreases in violent crime.

Our strategy is having an impact, in the form of crimes prevented and lives saved.

According to available data from 2023 — murder, rape, robbery, and aggravated assault show considerable declines from 2022.

And in nearly 90 major cities across the country, violent crime has continued to drop during the first six months of this year compared to the same time period last year, including a 17% decrease in homicides.

While these are promising trends, we can’t afford to let up.

Far from it.

We must continue our focus on the most significant drivers of violent crime and identifying emerging threats to our communities. 

We’re here to discuss one such emerging threat: machine gun conversion devices — or MCDs — also known as “switches” or “auto sears.”

These highly dangerous devices, that are often just a small piece of metal or plastic, can convert a run-of-the-mill firearm into a weapon of war.

From a shooting at a sweet sixteen party in Dadeville, Alabama, which claimed four lives — to a drive-by in Cincinnati, Ohio killing an 11-year-old boy in the crossfire — MCDs can transform a street corner into a combat zone, devastating entire communities.

The law classifies an MCD as an illegal machinegun.

I want to be clear — because of its destructive effect, the possession of an MCD is illegal under federal law.

So, the proliferation of these MCD devices requires our immediate and sustained attention.

Machinegun conversion devices convert handguns and rifles into machine guns.

The result is a deadly combination — more rapid firing — amounting to hundreds of bullets in mere minutes — with one pull of a trigger.

So even as the number of shootings goes down — when the spread of MCDs is unchecked, the number of fatalities can go up.

Using MCDs is illegal. Selling MCDs is illegal. And being in possession of MCDs is also illegal.

They’re cheap. They’re not hard to manufacture, often with 3-D printers. And they’ve been proliferating for years.

Today, MCDs are the most frequently recovered type of illegal firearm.

The growing use of MCDs by criminals presents a danger to the public and to brave members of law enforcement who put their lives on the line everyday — and who should not have to face such dangerous weaponry. 

So, given the clear danger MCDs pose to our communities, today, I am issuing a Department-wide directive, and we are taking action to confront this rising threat in three ways.

First, I am establishing the Justice Department’s Action Network to Terminate Illegal Machinegun Conversion Devices — or ANTI-MCD for short.

The ANTI-MCD Committee will be co-chaired by ATF and one of our U.S. Attorneys who’s been employing innovative strategies to address the MCD threat.

The committee will include representatives of the Department’s law enforcement agencies and prosecutorial components.

I’ll be asking the ANTI-MCD Committee for recommendations on how to best deploy Department resources to reduce the proliferation of MCDs.

To ensure seamless coordination, spot trends, and gather intelligence, the ANTI-MCD Committee will work with the Department’s law enforcement components to update the tracking of MCD seizures and prosecutions in real time.

And the Committee will help drive best practices for work across law enforcement and across government on joint initiatives and prosecution efforts to crack down on MCDs.

Key to getting MCDs off the streets is training those on the front lines confronting these deadly devices on the latest MCD technologies and enforcement authorities.

So, the second action I’m announcing today is the creation of a national MCD Training Initiative — spearheaded by ATF and designed to equip law enforcement and prosecutors with the tools they need to combat MCDs.

Given how quickly MCD design and distribution networks are evolving, ATF will continually update training driven by the latest intelligence.

Just today, the Bureau of Justice Assistance and ATF are releasing a new training module for law enforcement around the country, educating them on detecting and identifying MCDs.

And while we’re improving our training and data, we’ll also be adding to our capabilities.

ATF will designate a National MCD Coordinator — to serve as a hub of expertise for all our partners.

Now, as law enforcement adapts to the MCD landscape, so too must Department prosecutors, led by the U.S. Attorney community.

U.S. Attorneys’ Offices are already doing great work here — and I want to thank Chris Kavanaugh for his leadership representing our U.S. Attorneys today and for his work on this issue with the Attorney General’s Advisory Committee.

So, today, to continue building on that work, I’m directing all 94 U.S. Attorneys’ Offices to prioritize MCD prosecutions by employing comprehensive and district-specific MCD enforcement strategies.

Over the next 90 days, each U.S. Attorney’s office will meet with federal, state, local, Tribal, and territorial law enforcement partners to identify promising MCD-related enforcement practices.  

Many U.S. Attorneys are already doing this.

For example, Project Switch Off was launched late last year by Bob Troester, the U.S. Attorney for the Western District of Oklahoma. 

And working with ATF, his federal prosecutors have trained nearly 500 Oklahoma City police to recognize and refer MCD offenses for federal prosecution. 

His office has also provided training to the district’s judges to underscore the dangers posed by MCDs. 

Bob’s office is prioritizing the prosecution of MCD offenses.

In less than a year, the Western District of Oklahoma has charged nearly 40 individuals with MCD-related offenses — that’s compared to eight total between 2020 and 2022, before this initiative.

And you know what?

Switches aren’t appearing like they used to on their streets or on social media.

A member of the Oklahoma City Police Department recently reported to the U.S. Attorney the impact of these federal prosecutions, saying:  

Gang members are scared to death to use the switches because their buddies are going to federal prison…

“It is very clear your prosecutions are making a huge difference in our community.”

This is a powerful example of how — working together — we can make a difference for our communities. 

And that’s why I’ve asked Bob to serve as the co-chair of our ANTI-MCD Committee.

Now as we focus on getting MCDs off our streets, this much is clear: law enforcement can’t do this alone.

Today’s convening is a critical step, but we’re still at the beginning of this work — work that can’t be limited to how we train law enforcement and prosecute offenders.

It must also include stopping these devices from reaching criminals in the first place.

While many MCDs are manufactured in the United States, others are imported from overseas markets like China. 

We need to do more to disrupt that illicit flow.

We need to engage software developers, technology experts, and leaders in the 3-D printing industry to identify solutions in this fight. 

And we have to do all of this while raising public awareness about the deadly threat posed by MCDs.

Combating this threat will take all of us — industry, academia, and government — working together. 

Because, you know your industries and this technology better than anyone.

You are the ones leading the research that will inform the next innovations

You are the ones on the cutting edge in your sector.

You all bring different expertise to this challenge, but we all share the same goal: ensuring that those innovations and that technology isn’t being used to harm communities.

We will keep at this work — trying to stop the proliferation of MCDs.

Our ask is that when you return to your companies, agencies, and institutions, that you do the same. 

Today, with your help, your ideas and your commitment, we are moving this forward.

Once again — thank you — all of you — for leading the way.

I look forward to seeing where we go from here in our collective efforts to keep our communities safe.   

Justice Department to Monitor Compliance with Federal Voting Rights Laws in Rhode Island

Source: United States Department of Justice Criminal Division

The Justice Department announced today that it will monitor compliance with federal voting rights laws in the City of Pawtucket (in Providence County), Rhode Island, for the Sept. 10 primary election.

The Justice Department will assign federal observers to monitor the election in the City of Pawtucket to observe the county’s compliance with the Voting Rights Act. Earlier this year, a federal court approved a consent decree to resolve the department’s claims under Sections 203 of the Voting Rights Act regarding the availability of election assistance and materials in Spanish for Spanish-speaking voters with limited English proficiency in the City of Pawtucket. Section 203 requires that certain jurisdictions, including Pawtucket, provide election materials and assistance in other languages, in addition to English. The decree also addresses a claim under Section 302 of the Help America Vote Act. Section 302 requires jurisdictions to provide provisional ballots during federal elections. The consent decree authorizes federal observers to monitor election day activities in the county’s polling places.

The department regularly deploys its staff to monitor for compliance with federal civil rights laws in elections in communities across the country. In addition, the department also deploys federal observers from the Office of Personnel Management, when authorized by federal court order. 

The Civil Rights Division’s Voting Section, working with U.S. Attorneys’ Offices, enforces the civil provisions of federal statutes that protect the right to vote, including the Voting Rights Act, National Voter Registration Act, Help America Vote Act, Civil Rights Acts and the Uniformed and Overseas Citizens Absentee Voting Act.

More information about voting and elections is available on the Justice Department’s website at www.justice.gov/voting. Learn more about the Voting Rights Act and other federal voting laws at www.justice.gov/crt/voting-section. Complaints about possible violations of federal voting rights laws can be submitted through the Civil Rights Division’s website at civilrights.justice.gov or by telephone at 1-800-253-3931.