−Removed: DocGo is redefining healthcare.
−Removed: DocGo is leading the proactive healthcare revolution with an innovative care delivery platform that includes mobile health services, virtual care management and ambulance services.
−Removed: DocGo is helping to reshape the traditional four-wall healthcare system by providing high quality, highly accessible care to patients where and when they need it.
+Added: DocGo is leading the proactive healthcare revolution.
+Added: We are democratizing access with our innovative care delivery platform that includes mobile health services, virtual care management and ambulance services.
+Added: Our goal is to deliver healthcare at any address and help reshape the traditional healthcare system, driven by our mission to bring high quality, highly accessible care to all.
DocGo’s proprietary technology platform, dedicated network of certified health professionals and robust fleet of medical response vehicles provide services in 31 states and the United Kingdom.
−Removed: DocGo’s vertically integrated approach helps elevate the quality of patient care and drive business efficiencies for facilities, hospital networks and health insurance providers.
−Removed: We often provide our services in collaboration with leading healthcare organizations via long-term relationships that are intended to drive meaningful revenue, help provide efficient and effective capital allocation and create low-risk opportunities for significant growth.
−Removed: Our mission is to provide high quality, highly accessible healthcare for all, empowering the delivery of medical transportation and mobile healthcare outside the traditional “brick-and-mortar” facilities, with more accessible, affordable and efficient patient-centered care.
−Removed: Since 2015, through nearly 8 million patient interactions, we have created a care delivery model that helps provide better care outside of the physical walls of the healthcare system.
+Added: DocGo’s vertically integrated approach helps elevate the quality of patient care and drive business efficiencies for municipalities, hospital networks and health insurance providers.
+Added: We often provide our services in collaboration with leading healthcare organizations via long-term relationships that are intended to provide efficient and strategic capital deployment opportunities that can drive meaningful revenue and create significant growth.
+Added: Our mission is to provide high quality, highly accessible healthcare for all, empowering the delivery of mobile healthcare and medical transportation outside of traditional “brick-and-mortar” facilities, with more accessible, affordable and efficient patient-centered care.
+Added: In 2024 alone, our network of clinicians traveled over 8.8 million miles to facilitate care across more than 1.5 million patient interactions.
+Added: Since 2015, we have created a care delivery model that has facilitated better care for nearly 8 million patients beyond the traditional healthcare system.
We began by developing a state-of-the-art, intuitive platform designed to drive greater efficiency and improved access to patient care.
−Removed: Our innovative technology can change the way healthcare facilities manage patient transportation and eliminate many of the common obstacles faced when scheduling service, ultimately freeing medical professionals to focus more time and their valuable resources on what they do best — providing patient care.
−Removed: Additionally, in certain markets, our mobile health in-person care model facilitates medical treatment directly to patients in the comfort of their homes, workplaces and other non-traditional locations.
−Removed: Working under the guidance of prescribing physicians, our network of more than 700 medical clinicians as of December 31, 2023 (which includes Company employees, personnel from a variety of subcontracted labor agencies and some independent contractors) provides a wide range of tests, procedures, care gap closures and interventions that previously required a visit to a traditional healthcare setting.
−Removed: Such clinicians include, among others, licensed practical nurses (“LPNs”), registered nurses (“RNs”) and Advanced Practice Providers (“APPs”) assisted by additional support staff.
+Added: Our innovative technology can change the way healthcare facilities manage patient transportation and mobile health services, streamlining the process and freeing medical professionals to focus more time and their valuable resources on what they do best — caring for their patients.
+Added: Our mobile health model facilitates medical treatment directly to patients in the comfort of their homes, workplaces and other non-traditional locations.
+Added: The power of our model is the modality of care, specifically its scalability and lowered cost basis.
+Added: We combine the efficiency of telehealth by virtually pairing specialized Advanced Practice Providers (“APPs”) such as physician assistants and nurse practitioners with on-site clinicians in the patient’s home to be the APP’s eyes, ears, hands and feet.
+Added: Such clinicians include, among others, licensed practical nurses (“LPNs”) and registered nurses (“RNs”) assisted by additional support staff.
+Added: As of December 31, 2024, we deployed a network of more
+Added: than 600 medical clinicians, working under the guidance of prescribing clinicians to provide a wide range of care gap closures, tests, procedures and interventions that previously required a visit to a traditional healthcare setting.
+Added: Unlike virtual care providers who try using technology to replace the need for hands-on clinical intervention, our combined virtual and in-person care model leverages technology to enable connectivity, facilitate diagnostics and enhance the efficiency of our clinicians.
+Added: Facilitating hands-on care to patients where they are, when they need it is a vital part of our offering, because vaccines can’t be provided over the telephone, and bone density screenings can’t be completed via videochat.
+Added: Proactive healthcare not only improves patient health outcomes but can also significantly reduce overall cost burdens to the system.
+Added: Since inception, we estimate that our services have prevented over 85,000 unnecessary emergency department visits.
+Added: Based on Accountable Care Organization data from the Centers for Medicaid & Medicare Services (“CMS”), this has saved the U.S.
+Added: healthcare system an estimated $265 million.
+Added: We are increasingly working with insurance payers who require care gap closure services for their hard-to-reach patient populations, and we have been assigned over 500,000 patients from seven different payers whose patients need these services.
+Added: Reports indicate that over 25% of U.S.
+Added: patients lack a primary care provider (“PCP”), and we intend to enter partnerships with health plans that will enable us to facilitate PCP services for their patients, and then establish value-based reimbursement models that involve graduated risk-sharing arrangements.
+Added: These payment models are specifically designed to improve patient health outcomes while reducing overall costs, as reimbursement is tied to quality of care and effectively managing total cost of care.
+Added: We believe that sending clinicians into the home provides us with a more holistic view of a patient’s overall health, enabling us to approach risk-sharing arrangements with a more informed perspective.
DocGo has three reporting segments:
2 unchanged sentences
The traditional healthcare model requires patients to interact with many levels of healthcare providers — including receptionists, nurses, lab technicians and physicians — for even the most routine tests, procedures and interventions.
−Removed: We recognized that a number of these services could easily be performed by LPNs, RNs, APPs and other clinicians under the guidance of higher licensed practitioners, but in the comfort of a patient’s home or workplace.
−Removed: Our patient-centered approach helps limit the need for individuals to seek routine treatment in more expensive and environmentally exposed, less comfortable settings such as emergency departments and urgent care clinics.
+Added: We recognized that a number of these services could easily be performed by LPNs, RNs and other clinicians under the guidance of higher licensed practitioners, but in the comfort of a patient’s home or workplace.
+Added: Our patient-centered approach helps limit the need for individuals to seek routine treatment in more expensive and environmentally
+Added: exposed, less comfortable settings such as emergency departments and urgent care clinics.
In addition to providing greater convenience to patients, our Mobile Health Services help reduce unnecessary burdens on healthcare systems by freeing up their finite, in-person resources to address more urgent and critical patient needs.
DocGo’s clinical Mobile Health Services, which we expanded into the home and workplace in 2020, facilitate medical care via a turnkey suite of integrated, technology-enabled solutions.
−Removed: Through DocGo On-Demand and additional Mobile Health Services programs, we provide care for a diverse group of customers, including municipalities, hospitals and health systems, insurers, physician practices, businesses and employers.
−Removed: Additionally, our expanded population health offerings provide holistic health, social and shelter coordination services to underserved communities.
+Added: Through DocGo’s Mobile Health Services, we facilitate care for a diverse group of customers, including municipalities, hospitals and health systems, insurers, physician practices, businesses and employers.
+Added: Additionally, our expanded population health offerings provide holistic health and social services to underserved communities.
Our solutions encompass on-site evaluation, diagnostics, triage and treatment, including the services detailed in the following table:
We place an emphasis on early intervention, preventive care and chronic disease management.
−Removed: DocGo can address over 30 gaps in care for health plans, especially Medicare and Medicaid plans focused on HEDIS Star Ratings.
+Added: DocGo can address over 30 gaps in care for health plans, especially Medicare Advantage, Managed Medicaid and Marketplace plans focused on quality measures.
Our work with health plans on patient engagement and gap closure programs is growing, with programs in several states.
−Removed: As of the date of this Annual Report, we have active programs with Elevance Health, HealthFirst, EmblemHealth and others.
+Added: As of the date of this Annual Report, we have active programs with Elevance Health, HealthFirst, EmblemHealth, Molina, LA Care and others.
These programs allow us to address gaps in care for Medicare and Medicaid populations and help manage multiple chronic diseases.
Our priority and strategic focus is to grow and launch new programs and new geographies with our existing health plan partners who collectively cover approximately 63 million lives.
+Added: Additionally, we plan to facilitate PCP services for these health plan patients, and migrate to a value-based care model with insurance partners that includes graduated risk-sharing arrangements to reward us for improving patient outcomes while reducing the overall cost of care.
Our virtual care management programs monitor patients remotely and intervene before minor issues become major health crises.
−Removed: Our remote monitoring team currently works with more than 50,000 patients living with chronic
−Removed: conditions – and we intend to launch specialized virtual care programs with nephrology and additional specialty practice groups, including endocrinology and pulmonology.
−Removed: Proactive healthcare not only improves patient health outcomes but can also significantly reduce overall cost burdens on the system.
−Removed: Based on Accountable Care Organization data from the Centers for Medicaid & Medicare Services (“CMS”), we estimate that our services have saved more than $167 million in 2023 by preventing unnecessary emergency department visits .
−Removed: We also intend to enter into additional partnerships with health plans that use value-based reimbursement models that involve risk-sharing.
−Removed: These payment models are specifically designed to improve patient health outcomes while reducing overall costs, as reimbursement is tied to quality of care and effectively managing total cost of care.
−Removed: As patients seek more efficient, more convenient healthcare options, we believe our virtual care-enabling solutions are poised for significant growth by delivering a combination of in-person and virtual patient care previously inaccessible outside of the more traditional healthcare settings.
−Removed: The power of our model is the modality of care, specifically its scalability and lowered cost basis.
−Removed: We aim to combine the efficiency of telehealth by virtually pairing a specialized Physician Assistant (“PA”) with an LPN on-site in the patient’s home to be the PA’s eyes, ears, hands and feet.
−Removed: We partner with leading national health systems, insurance carriers, private organizations and employers, state and local governments and managed care organizations to provide our Mobile Health Services, including NYC Health + Hospitals, New York City Department of Housing Preservation and Development, Dollar General and Martin Luther King Jr.
−Removed: Memorial Hospital in Los Angeles, CA.
+Added: Our remote monitoring team currently works with approximately 50,000 patients living with chronic conditions.
+Added: As patients seek more efficient, more convenient healthcare options, we believe our care-enabling solutions are poised for significant growth by facilitating a combination of in-person and virtual patient care via our mobile health solutions.
+Added: We deliver a better patient experience, and a level of care previously inaccessible outside of the more traditional healthcare settings.
+Added: We partner with leading national health systems, insurance carriers, private organizations and employers, state and local governments and managed care organizations to provide our Mobile Health Services, including NYC Health + Hospitals, the U.S.
+Added: Department of Veterans Affairs, the Indian Health Service (IHS), Martin Luther King Jr.
+Added: Memorial Hospital in Los Angeles, CA and the National Health Service (NHS) in the United Kingdom.
In recent years, our government contract work has represented a substantial portion of our overall revenue, representing approximately 72%, 73% and 64% of revenues for the years ended December 31, 2024, 2023 and 2022, respectively, and maintaining and continuing to grow this revenue stream is an important part of our growth strategy.
2 unchanged sentences
Scores are measured from a range of -100 to +100 with scores over 30 commonly viewed as good and over 50 considered excellent.
−Removed: Our Mobile Health Services NPS score for the year ended December 31, 2023 was 81, which is a testament to our customers’ strong perception regarding the value of our services.
+Added: Our Mobile Health Services NPS score for the year ended December 31, 2024 was 87, which is a testament to the value of our services.
Transportation Services
−Removed: DocGo’s digitally-enabled medical transportation solutions are offered under the Ambulnz brand.
−Removed: We help provide reliable, efficient access to local clinical services, including primary and specialty care, dialysis treatments for chronic care management and transfers between clinical settings.
+Added: DocGo’s digitally-enabled medical transportation solutions are offered under our Ambulnz brand.
+Added: We help provide reliable, efficient transfers between clinical settings and access to clinical services, including primary and specialty care and dialysis treatments for chronic care management.
Every vehicle in our fleet is equipped with our proprietary technology platform, which is integrated with some of the nation’s largest electronic medical record (“EMR”) systems.
This integration with EMR systems is designed to provide seamless transfer of electronic patient information and discharge data to our healthcare provider customers, which helps improve order speed and accuracy and eliminate a myriad of manual processes.
−Removed: In addition, our ShareLink TM technology is designed to provide our healthcare partners and patients with real-time vehicle locations and accurate estimated time of arrivals and helps deliver valuable peace of mind.
−Removed: Consequently, our healthcare facility customers are better able to order, track and manage transportation requests and patient movement, thereby enhancing utilization of resources and cost.
+Added: In addition, our ShareLink TM technology is designed to provide our healthcare partners and patients with real-time vehicle locations and accurate estimated time of arrivals, helping deliver valuable peace of mind.
+Added: Consequently, our healthcare facility customers are better able to order, track and manage transportation requests and patient movement, employ more effective bed management, and thereby enhance utilization of resources and cost.
As of December 31, 2024, we had 596 vehicles in service throughout the United States and another 318 in the United Kingdom.
1 unchanged sentence
Our Corporate segment primarily represents shared services and personnel that support both the Transportation Services and Mobile Health Services segments.
−Removed: It contains operating expenses such as information technology costs, certain insurance costs and the compensation costs of senior and executive leadership.
+Added: It contains operating expenses such as information technology costs, certain insurance costs, the compensation costs of senior and executive leadership, and software development costs for our proprietary technology platform.
None of the Company’s revenues or costs of goods sold are reported within the Corporate segment.
+Added: We continue to add to our pool of talent, and in 2024, we hired top leaders to bolster our team, including Yong Kim who joined us from CVS, Jen McLean who joined us from City Harvest, and Eiwe Lingefors – our newly-appointed Chief Information Officer – who joined us from Capsule Pharmacy.
+Added: In May 2024, we announced the launch of DocGo’s Medical Advisory Board, which includes top industry specialists from Harvard Medical School, Mount Sinai Hospital, UT Health, and VillageMD.
+Added: In September 2024, we also announced that healthcare visionary Stephen K.
+Added: Klasko, MD, MBA – former President of Thomas Jefferson University and CEO of Jefferson Health – has joined as the non-executive Chair of DocGo’s Board of Directors.
+Added: These industry luminaries will continue to provide invaluable guidance and perspective to help elevate our clinical offerings and turbocharge our growth.
Human Capital Resources
We strive to hire the best talent across our industry, with a focus on inspiring performance.
−Removed: As of December 31, 2023, we had over 4,100 employees, including healthcare professionals, field management personnel and corporate support staff, as represented in the table below.
+Added: As of December 31, 2024, we had approximately 4,400 employees, including healthcare professionals, field management personnel and corporate support staff, as represented in the table below.
Healthcare professionals consist of emergency medical technicians (“EMTs”), paramedics, LPNs, RNs, APPs, clinicians and related support staff;
−Removed: field management personnel includes supervisors and
+Added: field management personnel
+Added: includes supervisors and managers;
and corporate support staff includes software development, billing, finance, human resources, legal and compliance, sales, marketing and executives.
22 unchanged sentences
One measure of this are the hundreds of positive reviews our employees have given DocGo on leading recruitment websites.
−Removed: As of the date of this Annual Report, DocGo’s employee rating on Indeed is 4.3 out of 5.0, and our employee rating on Glassdoor is 4.2 out of 5.0 - ratings that are significantly higher than many of our competitors in the healthcare industry .
−Removed: Additionally, DocGo earned a Great Place to Work TM certification, which is based entirely on feedback from employees, for the second year in a row in 2023.
+Added: As of the date of this Annual Report, DocGo’s employee rating on both Indeed and Glassdoor is 4.3 out of 5.0 - ratings that are significantly higher than many of our competitors in the healthcare industry .
+Added: Additionally, DocGo was named by U.S.
+Added: News & World Report as one of the 2024-2025 Best Companies to Work For - Northeast.
+Added: DocGo also earned a Great Place to Work TM certification for two consecutive years (2022-2023 and 2023-2024), which is based entirely on feedback from employees, and is in the process of seeking recertification in 2025.
We have created a number of programs to foster the professional development of our employees and help attract top-tier talent.
−Removed: Our staff of Training and Education Coordinators runs a robust, in-person onboarding program to help train employees and keep them up to date in relevant procedures and protocols.
−Removed: We are also an American Heart Association Training Site and offer in-house basic life support (BLS), advanced cardiovascular life support (ACLS) and pediatric advanced life support (PALS) training and certification to our clinicians who require such training.
+Added: Our staff of Training and Education Coordinators runs a robust, in-person orientation program to help train employees and keep them up to date in relevant procedures and protocols.
+Added: We also offer in-house Basic Life Support, Advanced Cardiovascular Life Support and Pediatric Advanced Life Support training and certification to our clinicians who require such training.
We are also a:
−Removed: • Private Authorized Training Center of the Airway Management Education Center offering The Difficult Airway Course:
+Added: • Private Authorized Training Center of the Airway Management Education Center and Public Authorized Training Center of the Airway Management Education Center in the State of Delaware offering The Difficult Airway Course:
EMS and other courses;
+Added: • Training Center of the American Heart Association offering Advanced Stroke Life Support;
• National Association of Emergency Medical Technicians Training Center offering Advanced Medical Life Support, Prehospital Trauma Life Support and other courses;
1 unchanged sentence
• Licensed Training Provider of the American Red Cross offering the Emergency Medical Responder Course and other courses;
−Removed: In addition, we are able to grant EMS continuing education units in New York, New Jersey, Pennsylvania and Texas and through partnerships with the Commission on Accreditation for Prehospital Continuing Education (CAPCE) and the Kentucky Board of Nursing.
−Removed: We have also implemented a self-paced online training program for Company policy and procedures training, mandated Occupational Safety and Health Administration (“OSHA”) training courses, clinical skills, customer service, diversity, HIPAA regulations, safety and compliance and annual documentation training.
−Removed: In addition, our drivers are trained in the Coaching the Emergency Vehicle Operator (CEVO) Ambulance course.
+Added: • Educational Licensee for the Stop The Bleed program.
+Added: In addition, we are able to grant EMS continuing education units in New York, New Jersey, Pennsylvania, Colorado, Wisconsin, Tennessee and Texas and through partnerships with Flight Bridge ED via the Commission on Accreditation for Prehospital Continuing Education and the Kentucky Board of Nursing.
+Added: We have also implemented a self-paced online training program for Company policy and procedures training, mandated Occupational Safety and Health Administration (“OSHA”) training courses, clinical skills, customer service, HIPAA regulations, safety and compliance and annual documentation training.
+Added: In addition, our drivers are trained in the Coaching the Emergency Vehicle Operator Ambulance course.
We also use a management system for credential tracking and Continuous Quality Improvement to help ensure that our staff maintains all required credentials relevant to their positions with the Company.
1 unchanged sentence
Course completion, assignments and other compliance requirements are tracked in this system as well.
−Removed: Verification monitoring ensures that all employees meet current state requirements.
+Added: Verification monitoring enables us to confirm that all employees meet current state requirements.
This tool verifies Office of Inspector General (“OIG”) of the U.S.
1 unchanged sentence
Our comprehensive training programs utilize a full range of resources, including print materials, training modules, webinars, seminars and videos provided by the Centers for Disease Control and Prevention and federal, state and local entities, medical institutions and public health agencies.
−Removed: In December 2021, we launched DocGo EMS Academy, a full-service program dedicated to recruiting and training emergency medical services (“EMS”) clinicians.
−Removed: Combining classroom education with practical hands-on learning, the program is designed to help existing healthcare professionals advance their careers and provide aspiring entry-level workers with the opportunity to enter the healthcare industry.
−Removed: DocGo EMS Academy is tailored to EMS workers, from EMTs to paramedics.
−Removed: This comprehensive training program is available in select states and offers free tuition for students who continue their employment with DocGo, which we anticipate could assist us in our recruiting efforts.
The Business Combination
3 unchanged sentences
Pursuant to the Merger Agreement and as described in the Company’s definitive proxy statement/consent solicitation/prospectus filed with the U.S.
−Removed: Securities and Exchange Commission (the “SEC”) on October 14, 2021, Merger Sub merged with and into Ambulnz, with Ambulnz continuing as the surviving corporation.
−Removed: As a result of the Business Combination, Ambulnz became a wholly-owned subsidiary of the Company, and each share of Series A preferred stock of Ambulnz, no par value, Class A common stock of Ambulnz, no par value, and Class B common stock of Ambulnz, no par value, was cancelled and converted into the right to receive a portion of merger consideration issuable as Common Stock, pursuant to the terms and conditions set forth in the Merger Agreement.
−Removed: In connection with the Business Combination, the Company raised $158.0 million, net of transaction costs of $20.0 million.
−Removed: This amount was comprised of (i) $43.4 million of cash held in the Company’s trust account established in connection with its initial public offering, net of the Company’s transaction costs and underwriters’ fees of $9.6 million, and (ii) $114.6 million of cash from the sale of shares of Common Stock to certain investors at a price of $10.00 per share
−Removed: in a private placement that closed concurrently with the Business Combination (the “PIPE Financing”), net of $10.4 million in transaction costs incurred in connection with the PIPE Financing.
−Removed: These transaction costs consisted of banking, legal and other professional fees, which were recorded as a reduction to additional paid-in capital.
+Added: Securities and Exchange Commission (the “SEC”) on October 14, 2021, Merger Sub merged with and into Ambulnz, with Ambulnz continuing as the surviving corporation and becoming a wholly-owned subsidiary of the Company.
healthcare industry is highly competitive, and we compete with a broad and diverse set of companies spanning both of our business segments.
The competitive landscape is highly fragmented for both technology-enabled mobile healthcare solutions and medical transportation services, ranging in each case from small, locally owned and operated providers to large national organizations.
−Removed: While we do not believe that any single competitor offers our vertically integrated suite of Mobile Health Services and Transportation Services, numerous companies offer components of mobile health and/or transportation services that compete with our solutions.
+Added: While we do not believe that any single competitor offers our vertically integrated suite of Mobile Health Services and Transportation Services, numerous “point solution” companies offer components of mobile health and/or transportation services that compete with our solutions.
Competition in the mobile health industry is primarily based on scale;
15 unchanged sentences
Competitors within the industry vary considerably in type and identity by market, with our primary competitors being small, locally owned operators as well as local fire departments and other local government providers.
−Removed: Larger private provider competitors include Modivcare, Falck, Global Medical Response, Southwest Ambulance, Paramedics Plus and Acadian Ambulance.
+Added: Larger private provider competitors include Modivcare, Falck, Global Medical Response (including its subsidiary American Medical Response, or AMR), Southwest Ambulance, Paramedics Plus and Acadian Ambulance.
Intellectual Property
1 unchanged sentence
We have registered “Ambulnz” and our corporate logo in the United States and the United Kingdom.
−Removed: We have registered the “DocGo” word mark and design in the United States, United Kingdom and EU.
+Added: We have registered the “DocGo” word mark and design in the United States, United Kingdom and EU, as well as the “ShareLink” word mark in the United States.
We are also the registered holder of a variety of domain names that include “Ambulnz,” “DocGo” and similar variations.
12 unchanged sentences
As the applicable laws and regulations change, we may be required to make conforming modifications in our business processes from time to time.
−Removed: In many jurisdictions where we operate, neither our current nor our anticipated business model, in particular with respect to our Mobile Health Services, has been the subject of judicial or administrative interpretation.
+Added: In many jurisdictions where we operate, neither our current nor our anticipated business model, in particular with respect to our Mobile Health Services, has been the subject of judicial or administrative
+Added: interpretation.
We cannot be assured that a review of our business by courts or regulatory authorities will not result in determinations that could limit or otherwise adversely affect our operations or that the healthcare regulatory environment will not change in a way that restricts our operations.
False Claims Act
−Removed: The federal False Claims Act is a means of policing false bills or false requests for payment in the healthcare delivery system.
−Removed: Among other things, the federal False Claims Act authorizes the imposition of up to three times the government’s damages and significant per claim civil penalties on any “person” (including an individual, organization or company) who, among other acts:
+Added: The civil False Claims Act (the “FCA”) protects the federal government from being overcharged or sold shoddy quality goods and services.
+Added: It is also a means of policing false bills or false requests for payment to or from the federal healthcare programs such as Medicare and Medicaid.
+Added: Among other things, the FCA authorizes the imposition of up to three times the government’s damages and significant per claim civil penalties on any “person” (including an individual, organization or company) who, among other acts:
• knowingly presents or causes to be presented to the federal government a false or fraudulent claim for payment or approval;
3 unchanged sentences
• conspires to commit the above acts.
−Removed: In addition, amendments to the federal False Claims Act and Social Security Act impose severe penalties for the knowing and improper retention of overpayments collected from government payors.
−Removed: Under these provisions, within 60 days of identifying and quantifying an overpayment, a provider is required to notify the Centers for Medicare and Medicaid Services (“CMS”) or the Medicare Administrative Contractor of the overpayment and the reason for it and return the overpayment.
−Removed: An overpayment impermissibly retained could subject a party to liability under the federal False Claims Act, exclusion from government healthcare programs, including Medicare and Medicaid, and penalties under the federal Civil Monetary Penalties Law discussed below.
−Removed: The federal False Claims Act provides for penalties that range from $5,500 to $11,000 (adjusted for inflation) for each false claim, plus up to three times the amount of damages caused by each false claim, which can be as much as the amounts received directly or indirectly from the government for each such false claim.
+Added: Since each item or service billed to Medicare or Medicaid is a “claim,” fines can be significant.
+Added: The fact that a claim results from a kickback or violates the Physician Self-Referral Law (i.e., the “Stark Law”) also may render it false or fraudulent, creating liability under the civil FCA, the federal Anti-Kickback Statute (“AKS”) or the Stark Law.
+Added: No specific intent to defraud is required under the civil FCA.
+Added: The civil FCA defines “knowing” to include not only actual knowledge but also instances in which a person (including an individual, organization or company) acts in deliberate ignorance or reckless disregard of the truth or falsity of the information.
+Added: Further, the civil FCA contains a whistleblower provision that allows private citizens (typically current or former business partners, hospital or office staff, patients or competitors) to file a lawsuit on behalf of the United States (called “qui tam” suits) against those who have defrauded the government.
+Added: Private citizens who successfully bring qui tam actions may receive a portion of the government’s monetary recovery.
+Added: In addition, amendments to the FCA and Social Security Act impose severe penalties for the knowing and improper retention of overpayments collected from government payors.
+Added: Under these provisions, within 60 days of identifying and quantifying an overpayment, a provider is required to notify the Centers for Medicare and Medicaid Services (“CMS”), the appropriate Medicare Administrative Contractor, or the U.S.
+Added: Department of Health and Human Services, Office of Inspector General (“HHS-OIG”) of any overpayment.
+Added: A provider must explain how the overpayment occurred and what steps it intends to take to reduce the likelihood of future overpayments and return the overpayment.
+Added: An overpayment impermissibly retained could subject a party to liability under the FCA, exclusion from government healthcare programs, including Medicare and Medicaid, and penalties under the federal Civil Monetary Penalties Law (“CMPL”) discussed below.
+Added: The FCA provides for penalties that range from $5,500 to $11,000 (adjusted for inflation) for each false claim, plus up to three times the amount of damages caused by each false claim, which can be as much as the amounts received directly or indirectly from the government for each such false claim.
On February 12, 2024, the U.S.
−Removed: Department of Justice issued a final rule announcing adjustments to federal False Claims Act penalties, under which the per claim range increases to a range from $13,946 to $27,894 per claim, so long as the underlying conduct occurred after November 2, 2015.
−Removed: The federal government has used the statute to prosecute a wide variety of alleged false claims and fraud allegedly perpetrated against Medicare and state healthcare programs, including but not limited to coding errors, billing for services not rendered, the submission of false cost or other reports, billing for services at a higher payment rate than appropriate, billing under a comprehensive code as well as under one or more component codes included in the comprehensive code,
−Removed: billing for care that is not considered medically necessary and false reporting of risk-adjusted diagnostic codes to Medicare Advantage (“MA”) (or Part C) plans.
−Removed: The Affordable Care Act of 2010 (the “Affordable Care Act”), as currently structured, provides that claims tainted by a violation of the federal Anti-Kickback Statute are false for purposes of the federal False Claims Act.
−Removed: Some courts have held that filing claims or failing to refund amounts collected in violation of the Stark Law can form the basis for liability under the federal False Claims Act.
−Removed: In addition to the provisions of the federal False Claims Act, which provide for civil enforcement through “qui tam” whistleblower lawsuits, the federal government can also use several criminal statutes to prosecute persons who are alleged to have submitted false or fraudulent claims for payment to the federal government.
+Added: Department of Justice (“DOJ”) issued a final rule announcing adjustments to FCA penalties, under which the per claim range increases to a range from $13,946 to $27,894 per claim, so long as the underlying conduct occurred after November 2, 2015.
+Added: The federal government uses the FCA to prosecute a wide variety of alleged false claims and fraud allegedly perpetrated against Medicare and state healthcare programs, including but not limited to improper coding, billing for services not rendered, the submission of false cost or other reports, billing for services at a higher payment rate than appropriate, billing under a comprehensive code as well as under one or more component codes included in the
+Added: comprehensive code (i.e., unbundling), billing for care that is not considered medically reasonable and necessary and false reporting of risk-adjusted diagnostic codes to Medicare Advantage (“MA”) (or Part C) plans.
+Added: Filing claims or failing to refund amounts collected in violation of the Stark Law can also form the basis for liability under the FCA.
+Added: In addition to the provisions of the FCA, which provide for civil enforcement through “qui tam” whistleblower lawsuits, the federal government can also use several criminal statutes to prosecute persons who are alleged to have submitted false or fraudulent claims for payment to the federal government.
Federal Fraud and Abuse Laws
−Removed: The federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations and related rules (collectively, “HIPAA”), established several separate criminal penalties for making false or fraudulent claims to insurance companies and other non-governmental payors of healthcare services.
−Removed: Under HIPAA, these two additional federal crimes are:
−Removed: “Healthcare Fraud” and “False Statements Relating to Healthcare Matters.” The Healthcare Fraud statute prohibits knowingly and recklessly executing a scheme or artifice to defraud any healthcare benefit program, including private payors.
−Removed: A violation of this statute is a felony and may result in fines, imprisonment or exclusion from government sponsored programs.
−Removed: The False Statements Relating to Healthcare Matters statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact by any trick, scheme or device or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
−Removed: A violation of this statute is a felony and may result in fines or imprisonment.
−Removed: This statute could be used by the government to assert criminal liability if a healthcare provider knowingly fails to refund an overpayment.
−Removed: These provisions are intended to punish some of the same conduct in the submission of claims to private payors as the federal False Claims Act covers in connection with governmental health programs.
−Removed: In addition, the Civil Monetary Penalties Law imposes civil administrative sanctions for, among other violations, inappropriate billing of services to federally funded healthcare programs and employing or contracting with individuals or entities who are excluded from participation in federally funded healthcare programs.
−Removed: Moreover, a person who offers or transfers to a Medicare or Medicaid beneficiary any remuneration, including waivers of co-payments and deductible amounts (or any part thereof), that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner or supplier of Medicare or Medicaid payable items or services may be liable for civil monetary penalties of up to $20,000 for each wrongful act.
−Removed: Moreover, in certain cases, providers who routinely waive co-payments and deductibles for Medicare and Medicaid beneficiaries can also be held liable under the federal Anti-Kickback Statute and federal False Claims Act, either of which can impose additional penalties associated with the wrongful act.
−Removed: One of the statutory exceptions to the prohibition is non-routine, unadvertised waivers of co-payments or deductible amounts based on individualized determinations of financial need or exhaustion of reasonable collection efforts.
−Removed: The OIG emphasizes, however, that this exception should only be used occasionally to address special financial needs of a particular patient.
−Removed: Although this prohibition applies only to federal healthcare program beneficiaries, the routine waivers of co-payments and deductibles offered to patients covered by commercial payors may implicate applicable state laws related to, among other things, unlawful schemes to defraud, excessive fees for services, tortious interference with patient contracts and statutory or common law fraud.
+Added: The federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations and related rules (collectively, “HIPAA”), is primarily known for its focus on the privacy and security of patient protected health information.
+Added: However, when promulgated, HIPAA also established several criminal penalties for making false or fraudulent claims to any healthcare benefit program, which includes all healthcare payors (i.e., both government healthcare programs and private health insurance companies) (the “Healthcare Fraud” and “False Statements Relating to Healthcare Matters” statutes).
+Added: The Healthcare Fraud statute prohibits knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program.
+Added: The False Statements Relating to Healthcare Matters statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact by any trick, scheme or device.
+Added: Additionally, the False Statements Relating to Healthcare Matters statute prohibits knowingly or willfully making any materially false, fictitious or fraudulent statement or representation, or making or using any materially false documentation, known to be materially false, fictitious or fraudulent in connection with the delivery of or payment for healthcare benefits, items or services.
+Added: A violation of either statute is a felony and may result in fines or imprisonment or lead to exclusion from government sponsored healthcare programs.
+Added: These provisions are intended to punish some of the same conduct in the submission of claims to private payors as the FCA covers in connection with governmental health programs.
+Added: In addition, the HHS-OIG can impose administrative sanctions under the CMPL for, among other violations:
+Added: • employing or contracting with individuals or entities who are excluded from participating in the federal healthcare programs;
+Added: • presenting a claim that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent;
+Added: • presenting a claim that the person knows or should know is for an item or service for which payment may not be made;
+Added: • violating the AKS;
+Added: • violating Medicare assignment provisions;
+Added: • violating the Medicare physician agreement;
+Added: • providing false or misleading information expected to influence a decision to discharge;
+Added: • failing to provide an adequate medical screening examination for patients who present to a hospital emergency department with an emergency medical condition or in labor;
+Added: • making false statements or misrepresentations on applications or contracts to participate in the federal healthcare programs.
+Added: Moreover, the CMPL prohibits, among other things, offering or providing remuneration to a Medicare or Medicaid beneficiary that is likely to influence the beneficiary to order or receive items or services payable by federal healthcare programs from a particular provider, practitioner or supplier.
+Added: “Remuneration” includes the transfers of items or services for free or for other than fair market value.
+Added: Penalties for violating the CMPL range from $10,000 to $50,000 per violation, adjusted annually for inflation.
+Added: For example, providers who routinely waive co-payments, co-insurance or deductible amounts (or any part thereof) can also be liable under the AKS and FCA, either of which can result in additional penalties.
+Added: While routine
+Added: waivers of such cost sharing obligations are not allowed, a statutory exception to the AKS permits waivers of co-payments, co-insurance or deductible amounts based on individualized determinations of financial need or following the exhaustion of reasonable collection efforts.
+Added: The HHS-OIG emphasizes, however, that such waivers should only be used occasionally to address special financial needs of a particular patient.
+Added: Although this prohibition applies only to waivers of cost sharing amounts for federal healthcare program beneficiaries, the routine waivers of co-payments, co-insurance or deductibles offered to patients may violate the terms of commercial contracts as well as may implicate applicable state laws related to, among other things, unlawful schemes to defraud, excessive fees for services, tortious interference with patient contracts and statutory or common law fraud.
State Fraud and Abuse Laws
1 unchanged sentence
The scope of these laws and the interpretations thereof vary from state to state and are enforced by state courts and regulatory authorities, each with broad discretion.
−Removed: Some state fraud and abuse laws apply to items or services reimbursed by any payor, including patients and commercial insurers, not just those reimbursed by a federally funded healthcare program.
+Added: Some state fraud and abuse laws apply to items or services reimbursed by any payor, including patients and commercial insurers, and not just those reimbursed by a federally funded healthcare program.
A determination of liability under such state fraud and abuse laws could result in fines and penalties and restrictions on our ability to operate in these jurisdictions.
2 unchanged sentences
federal and state laws and regulations related to the privacy and security of personally identifiable information (“PII”), including health information.
−Removed: In particular, HIPAA establishes privacy and security standards that limit the use and disclosure of protected health information (“PHI”) and require the implementation of administrative, physical and technical safeguards to ensure the confidentiality, integrity and availability of individually
−Removed: identifiable health information in electronic form.
+Added: In particular, HIPAA establishes privacy and security standards that limit the use and disclosure of protected health information (“PHI”) and require the implementation of administrative, physical and technical safeguards to ensure the confidentiality, integrity and availability of individually identifiable health information in electronic form.
HIPAA’s requirements apply to “covered entities” and their independent contractors, agents and other “business associates” that create, receive, maintain or transmit PHI in connection with providing services to covered entities.
−Removed: Although we are a covered entity under HIPAA, we are also a business associate of other covered entities when we are working on behalf of our healthcare provider partners.
+Added: Certain of our affiliate entities provide healthcare services and, therefore, are considered covered entities under HIPAA.
+Added: Additionally, other affiliate entities provide services on behalf of our healthcare provider partners, which creates a business associate relationship between the parties.
Violations of HIPAA may result in civil and criminal penalties.
9 unchanged sentences
In addition, HIPAA mandates that HHS conduct periodic compliance audits of HIPAA-covered entities and their business associates for compliance.
−Removed: It also tasks HHS with establishing a methodology whereby harmed individuals who were the victims of breaches of unsecured PHI may receive a percentage of the fine paid by the violator under the Civil Monetary Penalties Law.
+Added: It also tasks HHS with establishing a methodology whereby harmed individuals who were the victims of breaches of unsecured PHI may receive a percentage of the fine paid by the violator under the CMPL.
In light of recent enforcement activity and statements from HHS, we expect increased federal and state HIPAA privacy and security enforcement efforts.
−Removed: HIPAA also requires HHS to adopt national standards establishing electronic transaction standards that all healthcare providers must use when submitting or receiving certain healthcare transactions electronically.
+Added: HIPAA also requires that covered entities and business associates adhere to HHS-adopted national standards establishing electronic transaction standards when transmitting certain healthcare data electronically.
Many states in which we operate and in which our customers reside also have laws that protect the privacy and security of sensitive and personal information, including health information.
3 unchanged sentences
In certain cases, it may be necessary to modify our systems or planned operations to comply with these more stringent state laws.
−Removed: Not only may some of these state laws impose fines and penalties upon violators, but also some, unlike HIPAA, may afford private rights of action to individuals who believe their personal information has been misused.
−Removed: In addition, state laws are changing rapidly, and there is discussion of a new federal privacy law or federal breach notification law, to which we may be subject.
−Removed: In recent years, there have been a number of well-publicized data breaches involving the improper use and disclosure of PII and PHI.
−Removed: Many states have responded to these incidents by enacting laws requiring holders of personal information to maintain safeguards and to take certain actions in response to a data breach, such as providing prompt notification of the breach to affected individuals and state officials.
−Removed: In addition, under HIPAA and pursuant to the related contracts that we enter into with our healthcare provider partners and other third parties, we must report breaches of unsecured PHI to our contractual partners following discovery of the breach.
−Removed: Notification must also be made in certain circumstances to affected individuals, federal authorities and others.
−Removed: In addition to HIPAA, state health information privacy and state health information privacy laws, we may be subject to other state and federal privacy laws, including laws that prohibit unfair privacy and security practices and deceptive statements about privacy and security and laws that place specific requirements on certain types of activities, such as data security and texting.
+Added: Not only may some of these state laws impose fines and
+Added: penalties upon violators, but also some, unlike HIPAA, may afford private rights of action to individuals who believe their personal information has been misused.
+Added: Additionally, both federal and state laws and rules governing data security and privacy are constantly evolving and may require additional modification to our systems or planned operations to comply with such changes.
+Added: In addition to HIPAA, state health information privacy and state health information privacy laws, we may be subject to other state and federal privacy laws, including, but not limited to, the Federal Trade Commission (“FTC”) Act, which prohibit unfair privacy and security practices and deceptive statements about privacy and security and laws that place specific requirements on certain types of activities, such as data security and texting.
Anti-Kickback Statute
−Removed: The federal Anti-Kickback Statute is a broadly worded prohibition on the knowing and willful offer, payment, solicitation or receipt of any form of remuneration in return for, or to induce, (i) the referral of a person covered by Medicare, Medicaid or other governmental programs, (ii) the furnishing or arranging for the furnishing of items or services reimbursable under Medicare, Medicaid or other governmental programs or (iii) the purchasing, leasing or ordering or arranging or recommending purchasing, leasing or ordering of any item or service reimbursable under Medicare, Medicaid or other governmental programs.
−Removed: Certain federal courts have held that the Anti-Kickback Statute can be violated if “one
−Removed: purpose” of a payment is to induce referrals.
−Removed: In addition, a person or entity does not need to have actual knowledge of this statute or specific intent to violate it to have committed a violation, making it easier for the government to prove that a defendant had the requisite state of mind or “scienter” required for a violation.
−Removed: Moreover, the government may assert that a claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act.
−Removed: Violations of the Anti-Kickback Statute can result in exclusion from Medicare, Medicaid or other governmental programs as well as civil and criminal penalties, including fines of $120,816 per violation, plus up to three times the amount of the unlawful remuneration, and imprisonment of up to ten years.
−Removed: Civil penalties for such conduct can further be assessed under the federal False Claims Act.
−Removed: In addition to a few statutory exceptions, the OIG has published safe harbor regulations that outline categories of activities that are deemed protected from prosecution under the Anti-Kickback Statute provided all applicable criteria are met.
−Removed: The failure of a financial relationship to meet all of the applicable safe harbor criteria does not necessarily mean that the particular arrangement violates the Anti-Kickback Statute.
−Removed: However, conduct and business arrangements that do not fully satisfy each applicable safe harbor may result in increased scrutiny by government enforcement authorities, such as the OIG.
+Added: The AKS makes it a criminal offense to knowingly and willfully offer, pay, solicit or receive any remuneration to induce, or in return for the referral of an individual to a person for the furnishing of, or arranging for the furnishing of, any item or service reimbursable under a federal healthcare program.
+Added: The statute’s prohibition also extends to remuneration to induce, or in return for, the purchasing, leasing or ordering of, or arranging for or recommending the purchasing, leasing or ordering of, any good, facility, service or item reimbursable by a federal healthcare program.
+Added: “Remuneration” under the AKS includes the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind.
+Added: Remuneration can take many forms besides cash, such as free rent, expensive hotel stays and meals and excessive compensation for medical directorships or consultancies.
+Added: The AKS covers the payers of kickbacks (i.e., those who offer or pay remuneration) as well as the recipients of kickbacks (i.e., those who solicit or receive remuneration).
+Added: The kickback prohibition applies to all sources of referrals, even patients, and each party's intent is a key element of their liability under the AKS.
+Added: The AKS can be violated if “one purpose” of the remuneration is to induce referrals for items or services reimbursable by a federal healthcare program.
+Added: Moreover, the government may assert that a claim including items or services resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the FCA.
+Added: Violations of the AKS constitute a felony punishable by a maximum inflation-adjusted fine of $124,732 per violation, imprisonment up to 10 years, or both.
+Added: Administrative sanctions for violating the AKS may include exclusion from participating in Medicare, Medicaid or other federal healthcare programs.
+Added: Under the CMPL, physicians who pay or accept kickbacks also face penalties of up to $50,000 per kickback plus three times the amount of the kickback at issue.
+Added: Kickback violations can also lead to FCA liability.
+Added: In addition to a few statutory exceptions, the OIG has published safe harbor regulations that outline categories of activities that are deemed protected from prosecution under the AKS provided all applicable criteria are met.
+Added: Compliance with a safe harbor is voluntary.
+Added: The failure of a financial relationship or conduct to meet all criteria of an applicable safe harbor does not necessarily mean that the particular arrangement or conduct violates the AKS.
+Added: Rather, if an arrangement or conduct does not satisfy all of the requirements to fit within a particular safe harbor, government regulators engage in a fact-specific, case-by-case inquiry to assess whether an arrangement or conduct violates the AKS or not.
+Added: However, conduct and business arrangements that do not fully satisfy each applicable safe harbor may result in increased scrutiny by government enforcement authorities, such as the HHS-OIG or DOJ.
+Added: Kickbacks in healthcare are problematic because they may lead to overutilization, increased program costs, corruption of medical decision-making, patient steering and unfair competition.
+Added: Besides the AKS, the beneficiary inducement statute also imposes civil money penalties on providers who offer remuneration to Medicare and Medicaid beneficiaries to influence them to use their services.
+Added: The government does not need to prove patient harm or financial loss to the federal healthcare programs to show a violation of the AKS.
+Added: In fact, a provider can be guilty of violating the AKS even if the provider rendered medically necessary items or services to a Medicare or Medicaid beneficiary.
Federal Stark Law
−Removed: Section 1877 of the Social Security Act, also known as the physician self-referral law and commonly referred to as the Stark Law, prohibits a physician who has a financial relationship, or who has an immediate family member who has a financial relationship, with entities providing certain designated health services from referring Medicare patients to such entities for the furnishing of designated health services, unless an exception applies.
+Added: Section 1877 of the Social Security Act, also known as the Physician Self-Referral Law and commonly referred to as the Stark Law, prohibits a physician from making referrals for “designated health services” payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship, unless the requirements of an applicable exception are satisfied.
+Added: The Stark Law also prohibits an entity from filing claims with Medicare (or billing another individual, entity, or third-party payor) for any improperly referred designated health services.
+Added: A financial relationship may be an ownership or investment interest in the entity or a compensation arrangement with the entity.
Although uncertainty exists, federal agencies and at least one court have taken the position that the Stark Law also applies to Medicaid.
−Removed: Designated health services are defined to include, among others, clinical laboratory services, physical therapy services, occupational therapy services, radiology services including ultrasound services, durable medical equipment and supplies, parenteral and enteral nutrients, equipment and supplies, home health services, outpatient prescription drugs, inpatient and outpatient hospital services and outpatient speech-language pathology services.
+Added: Designated health services are defined to include, among others, clinical laboratory services, physical therapy services, occupational therapy services, radiology and certain other imaging services, durable medical equipment
+Added: and supplies, parenteral and enteral nutrients, equipment and supplies, home health services, outpatient prescription drugs, inpatient and outpatient hospital services and outpatient speech-language pathology services.
The types of financial arrangements between a physician and an entity providing designated health services that trigger the self-referral prohibitions of the Stark Law are broad and include direct and indirect ownership and investment interests and compensation arrangements.
−Removed: The Stark Law prohibits any entity providing designated health services that has received a prohibited referral from presenting, or causing to be presented, a claim or billing for the services arising out of the prohibited referral.
−Removed: Similarly, the Stark Law prohibits an entity from “furnishing” a designated health service to another entity in which it has a financial relationship when that entity bills for the service.
−Removed: The Stark Law also prohibits self-referrals within an organization by its own physicians, although broad exceptions exist.
−Removed: The prohibition applies regardless of the reasons for the financial relationship and the referral.
−Removed: Unlike the federal Anti-Kickback Statute discussed above, the Stark Law is a strict liability statute, which means proof of specific intent to violate the law is not required.
+Added: The Stark Law is a strict liability statute, which means proof of specific intent to violate the law is not required.
+Added: The Stark Law prohibits the submission, or causing the submission, of claims in violation of the law’s restrictions on referrals.
+Added: The Stark Law, however, establishes a number of specific exceptions and grants the HHS Secretary the authority to create regulatory exceptions for financial relationships that do not pose a risk of program or patient abuse.
+Added: The failure to meet an exception may result in significant consequences.
If the Stark Law is implicated, the financial relationship must fully satisfy a Stark Law exception.
−Removed: If an exception is not satisfied, then the parties to the arrangement could be subject to sanctions, including denial of payment for claims for services provided in violation of the statute, mandatory refunds of amounts collected for such services, civil penalties of up to $29,899 for each violation and twice the dollar value of each such service as well as possible exclusion from future participation in the federally funded healthcare programs, including Medicare and Medicaid.
+Added: If an exception is not satisfied, then the parties to the arrangement could be subject to sanctions, including denial of payment for claims for services provided in violation of the statute, mandatory refunds of amounts collected for such services, imposition of civil money penalties of up to $29,899 (adjusted annually for inflation) for each violation and three times the dollar value of each such service as well as possible exclusion from participation in the federally funded healthcare programs, including Medicare and Medicaid.
A person who engages in a scheme to circumvent the Stark Law’s prohibitions may be fined up to $199,338 for each applicable arrangement or scheme.
−Removed: Amounts collected on claims related to prohibited referrals must be reported and refunded generally within 60 days after the date on which the overpayment was identified.
−Removed: In addition, the government and some courts have taken the position that claims presented in violation of the various statutes, including the Stark Law, and failure to return overpayments in a timely manner can form the basis for liability under the federal False Claims Act discussed above based on the contention that a provider impliedly certifies compliance with all applicable laws, regulations and other rules when submitting claims for reimbursement.
+Added: CMS’s Voluntary Self-Referral Disclosure Protocol sets forth a process to enable providers of services and suppliers to self-disclose actual or potential violations of the physician self-referral law.
+Added: Additionally, pursuant to the Affordable Care Act of 2010 (the “Affordable Care Act”), the HHS Secretary has the authority to reduce the amount due and owing for Stark Law violations.
+Added: Amounts collected on claims related to prohibited referrals must be reported and refunded generally within 60 days after the date on which the overpayment was identified and quantified.
+Added: In addition, the government and some courts have taken the position that claims presented in violation of the various statutes, including the Stark Law, and failure to return overpayments in a timely manner can form the basis for liability under the FCA.
Corporate Practice of Medicine;
Fee Splitting
−Removed: The laws and regulations relating to our operations vary from state to state and many states prohibit general business corporations, such as us, from practicing medicine, controlling physicians’ medical decisions or engaging in some practices such as splitting professional fees with physicians.
−Removed: We contract with healthcare providers, physicians or physician-owned professional associations and professional corporations as part of our business.
−Removed: An important aspect of our strategy is to form contractual relationships with different third-party providers pursuant to which we provide them or their patients with medical transportation and/or mobile health services and they pay us for those services out of the fees they collect from patients and third-party payors.
−Removed: In certain instances, we also share a portion of our revenues with our partners.
−Removed: These contractual relationships are subject to various state laws that prohibit fee splitting or the practice of
−Removed: medicine by lay entities or persons and are intended to prevent unlicensed persons from interfering with or influencing the physician’s professional judgment.
+Added: The laws and regulations relating to our operations vary from state to state and many states prohibit general business corporations, such as us, from practicing medicine, controlling physicians’ or other clinicians’ medical decisions or engaging in some practices such as splitting professional fees with clinicians.
+Added: Among other assistance, we provide administrative services, billing services, marketing services, information technology services and make our intellectual property available to healthcare providers, physicians or physician-owned professional associations and professional corporations as part of our business.
+Added: An important aspect of our strategy is to form contractual relationships with different providers pursuant to which we assist them with providing their patients with medical transportation and/or mobile health services and they pay us for those services out of the fees they collect from patients and third-party payors.
+Added: The contractual relationships we enter into are subject to various state laws that prohibit fee splitting or the practice of medicine by lay entities or persons and are intended to prevent unlicensed persons from interfering with or influencing the physician’s professional judgment.
In addition, various state laws also generally prohibit the sharing of professional services income with nonprofessional or business interests.
−Removed: Activities other than those directly related to the delivery of healthcare may be considered an element of the practice of medicine in many states.
−Removed: Under the corporate practice of medicine restrictions of certain states, decisions and activities such as scheduling, contracting, setting rates and the hiring and management of non-clinical personnel may implicate the restrictions on the corporate practice of medicine.
+Added: Some activities may be considered an element of the practice of medicine in many states, even though they are not directly related to the delivery of healthcare services.
+Added: Accordingly, we must monitor our compliance with laws in every jurisdiction in which we operate on an ongoing basis, and we cannot provide assurance that our activities and arrangements, if challenged, will be found compliant.
+Added: Additionally, it is possible that the laws and rules governing the practice of medicine and fee splitting in one or more jurisdictions may change, or be interpreted differently, in a manner adverse to our business.
+Added: While our contractual arrangements state that we cannot control, influence, or otherwise interfere with the practice of medicine, and provide that licensed physicians retain exclusive control and responsibility for all aspects of the practice of medicine and the delivery of medical services, we cannot assure you that our contractual arrangements and activities are free from scrutiny from governmental authorities.
+Added: In addition, we take steps to confirm the fees for the services we provide are commercially reasonable and fair market value.
State corporate practice of medicine and fee-splitting laws vary from state to state and are not always consistent.
In addition, these requirements are subject to broad powers of interpretation and enforcement by state regulators.
−Removed: Regulatory authorities or other parties may assert that, despite these arrangements, we are engaged in the corporate practice of medicine or that our contractual arrangements with affiliated third parties constitute unlawful fee splitting.
−Removed: In this event, failure to comply could lead to adverse judicial or administrative action against us and/or our healthcare provider partners, civil or criminal penalties, receipt of cease-and-desist orders from state regulators, loss of licenses and the need to make changes to the terms of engagement with our provider partners that interfere with our business.
+Added: Notwithstanding the protections and limitations that are in place, the possibility of a determination that our contractual arrangements create an impermissible delegation of clinical control and/or impermissible fee-splitting by a physician practice to an unlicensed person remains.
+Added: Such a determination could lead to adverse judicial or administrative action
+Added: against us and/or the healthcare providers we contract with;
+Added: civil or criminal penalties;
+Added: the inability to contract with managed care companies or governmental payors;
+Added: receipt of cease-and-desist orders from state regulators;
+Added: loss of licenses;
+Added: and the need to make changes to the terms of engagement with the providers that we contract with, which could substantially interfere with our business.
International Regulation
25 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.