Boston-based American Robotics is approved to operate its Scout unmanned aircraft in rural areas and below a certain altitude, achieving a milestone that may allow the industry to ‘truly take off’
Routine drone delivery of clinical laboratory specimens and medical supplies moved a step closer to reality with the Federal Aviation Administration’s (FAA) green light to American Robotics (AR) to operate its fully automated drones without on-site pilots or on-the-ground spotters.
The Massachusetts-based company becomes the first drone operator to receive an FAA Certificate of Waiver, allowing it to operate its unmanned aircraft “beyond the visual line of sight (BVLOS) of the remote pilot in command.”
According to a news release, “Prior waivers and certifications awarded by the FAA required visual observers (VOs) stationed along the flight path to keep eyes on the airspace at all times, or required other burdensome restrictions such as infrastructure masking. … With this approval, American Robotics’ Scout System is now the first drone technology allowed to continuously operate without this costly human requirement.”
The FAA is restricting American Robotics’ operations to specific rural areas and at altitudes below 400 feet, with a maximum takeoff weight of 20 pounds, The Hill reported. Nevertheless, should AR’s automated Scout System prove safe, pilotless drones may soon be delivering clinical laboratory specimens and supplies to remote areas as well as to more densely populated hospital systems.
The FAA’s Certificate of Waiver is effective until January 31, 2023.
A New Era of Drone Delivery for Hospitals and Clinical Laboratories
Even with the restrictions, the FAA’s decision moves the commercial drone industry ever closer to routine transport of medical laboratory specimens and medical supplies by unmanned aerial vehicles (UAV).
“With these approvals, American Robotics is ushering in a new era of widespread automated drone operations,” Reese Mozer, CEO and co-founder of American Robotics, said in the news release. “Decades’ worth of promise and projection are finally coming to fruition. We are proud to be the first company to meet the FAA’s comprehensive safety requirements, which had previously restricted the viability of drone use in the commercial sector.”
The Wall Street Journal (WSJ) reported that the FAA’s decision signals the agency’s “broader effort to authorize widespread flights by shifting away from case-by-case exemptions for specific vehicles performing specific tasks.” According to the WSJ, the FAA’s approval documents state that American Robotics’ proposed operations will provide the agency with “critical data for use in evaluating BVLOS [beyond the visual line of sight] operations from offsite locations.”
Each American Robotics Scout drone (above) is stored within a weatherproof base station that enables autonomous charging, data processing, analysis, and data transmission. According to the news release, “Once installed in the field, all facets of Scout’s operation are automated, allowing this technology to gather and analyze ultra-high-resolution data multiple times per day for years without expensive human labor.” Clinical laboratory managers will want to watch for progress in using drones to deliver medical supplies. (Photo copyright: American Robotics.)
FAA Approval a ‘Game Changer’
In its quest to receive FAA approval, American Robotics completed a four-year testing program around its Scout line of UAV products. According to the company, Scout systems flew as many as 10 automated missions per day in 2020 for industrial and agricultural customers in multiple states capturing a variety of advanced data.
The Scout system addresses safety concerns by using acoustic detect-and-avoid technology to maintain a safe distance from other aircraft while also avoiding birds or other potential obstacles.
“The commercial drone industry is growing quickly and providing significant benefits to the American public, but enabling expanded operations beyond visual line of sight is critical for the industry to truly take off,” Lisa Ellman, JD, Partner at Hogan Lovells and Executive Director of the Commercial Drone Alliance, said in the news release.
“Automated beyond visual line of site operations are particularly important to opening the commercial sectors to the drone economy, including the agriculture and industrial verticals. Key to these operations is the use and FAA acceptance of new and innovative safety technologies, such as detect and avoid sensors and software-enabled automation.”
The agricultural and energy industries are seen as key beneficiaries of this latest FAA action. Lance Ruppert, Director of Agronomy Marketing and Technology at Growmark Inc., a leading US grower cooperative, calls the American Robotics’ approval a “game changer.”
“Our interest in American Robotics’ technology started with the desire to have a drone imagery solution that was reliable, scalable, and executed with minimal human resources,” Ruppert said in the news release. “This technology, along with the FAA approvals to operate it without humans on the ground, is key to making drones a widespread reality in our industry.”
Drone Delivery of Clinical Laboratory Specimens Worldwide
And past Dark Daily ebriefings reported on drone delivery of medical supplies being conducted in Virginia, North Carolina, Australia, Switzerland, and Rwanda. With potentially fully automated systems just around the corner, there’s no question the use of drones to transport critical medical supplies and biological specimens is poised for an amazing breakthrough.
While the FAA’s approval of the first fully automated commercial drone flights may not have an immediate impact on clinical laboratories, the increasing use of commercial drones brings drone transportation of lab specimens and other medical supplies one step closer to reality.
New healthcare fraud prevention partnership white paper outlines the most common abuses and the reasons clinical laboratories are susceptible to fraudulent practices
When it comes to questionable marketing and billing practices for lab testing, clinical laboratory companies can expect increased scrutiny and enforcement actions by federal healthcare authorities. That’s one message in a recently-issued white paper that was jointly authored by the Centers for Medicare and Medicaid Services (CMS) and the Healthcare Fraud Prevention Partnership (HFPP).
Systemic Challenges That Put Clinical Labs at Risk
High-volume, low-dollar nature of ordering, providing, and billing for clinical laboratory services; and,
Technical complexity and continuing evolution of clinical laboratory services.
While HFPP, a public-private partnership of healthcare payers and allied organizations, notes it is difficult to put a price on the cost of laboratory fraud and abuse, it concludes, “[Fraud] can negatively impact patient care and outcomes, cause financial harm to legitimate service providers and drive up the cost of care for all.”
The CMS/HFPP white paper points out that fraud within the clinical laboratory industry typically is related to abuse of billing standards, improper laboratory relationships, and medically unnecessary testing, such as:
As the spotlight intensifies on an industry ripe for potential abuse, criminal and civil penalties for fraudulent and/or improper billing for medical laboratory services skyrocket as well.
This means clinical laboratory managers and pathologists can no longer simply rely on written compliance programs. They must implement compliance procedures that can stand up to investigations and enforcement actions and keep pace with frequently changing laws and regulations.
Diagnostic laboratories that fail to comply with healthcare fraud and abuse regulations face increasing legal risk. The Bipartisan Budget Act of 2018 (BBA) doubled many healthcare fraud and abuse penalties. The maximum penalties under U.S. Code § 1320a–7a—the Civil Monetary Penalties Law (CMPL)—for knowingly filing an improper claim jumped to $20,000; $30,000; or $100,000, depending on the violation.
Similarly, the maximum financial penalty related to payments to induce the reduction or limitation of services increased from $2,000 to $5,000. Criminal penalties for felony convictions of the Anti-Kickback Statute (AKS) also were substantially increased. Previously, a provider who violated the AKS could be fined as much as $25,000 and receive a maximum five-year prison sentence. As of February 9, 2018, AKS violations now can result in a maximum fine of $100,000 and up to a 10-year prison term.
Since 2015, monetary penalties for non-compliance with CMPL and AKS regulations have included an annual inflation adjustment, making the recently enacted increases less dramatic than they first appeared. Nonetheless, the BBA has upped the ante for clinical laboratories.
Protecting Your Clinical Laboratory Against Compliance Violations
“The BBA contained key changes to federal healthcare fraud statutes that, on the whole, reflect ongoing Congressional efforts to heighten penalties for healthcare fraud infractions. The revisions to the AKS and CMPL will, in Congress’s view, raise the stakes companies and individuals face in healthcare fraud cases,” noted law firm Hogan Lovells of Washington, D.C.
Melissa Jampol (left) and Charles Dunham, IV (right), are with Epstein Becker and Green, P.C., a national law firm with decades of experience focusing on healthcare and life science regulatory and enforcement issues that impact clinical and anatomic pathology laboratories, hospitals and health systems, and physician group practices and networks. (Photo copyrights: Epstein Becker and Green.)
During this valuable webinar, you will hear from two legal experts—Charles Dunham, IV, (above right) and Melissa Jampol (above left)—both of Epstein Becker and Green, P.C. (EBG). They have extensive healthcare industry regulatory experience and understand the enforcement process. They will provide diagnostic laboratories with a critical understanding of:
Department of Justice operations, procedures and techniques for fraud enforcement, as well as laboratory actions that could be viewed as signs of potential fraud or abuse;
Non-governmental enforcement procedures and techniques used by private health insurers;
Tools for dealing with enforcement procedures or actions;
How to build a compliance program that becomes infused in the culture of a clinical laboratory’s operations; and,
Best practices designed to protect your lab from compliance violations or to mitigate potential problems, and more.
First to speak will be Charles Dunham, who is a partner at EBG. His national practice includes representation of healthcare providers and health-related entities. He has a particular focus on clinical and anatomic pathology laboratories, hospitals and health systems, and physician group practices and networks. His national clientele provides him with a wide view of the latest and most important developments in how laboratories, hospitals, and physicians need to comply with state and federal laws.
Clinical lab managers and pathologists participating in the webinar will get a unique, insider’s perspective from the co-presenter. Melissa Jampol is a former Assistant U.S. Attorney now at EBG. In this role, she has significant experience interacting with a range of federal and state law enforcement agencies on cases involving healthcare fraud and abuse. Her earlier experience includes more than six years as an Assistant District Attorney at the New York County District Attorney’s office.
To register for this crucial webinar and see essential details about discussion topics, use this link (or copy and paste this URL into your browser: https://pathologywebinars.com/current/the-new-cms-white-paper-on-healthcare-fraud-prevention-what-you-need-to-know-how-you-can-avoid-its-consequences-and-what-to-do-if-you-are-a-target-of-this-enforcement/).
While only a small percentage of labs engage in fraudulent business practices, all laboratory organizations today are subject to increased scrutiny and potential enforcement action. This essential webinar will provide in-depth information for laboratory managers and pathologists seeking practical advice on how to decrease non-compliance risks.
Don’t miss this unique opportunity to proactively protect your lab or pathology group from future problems, and learn how to respond if you are the subject of a payer audit, served with a Civil Investigative Demand letter, a subpoena, or other action. Register today!
