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• Enhance operational efficiencies and productivity by delivering on integration;
−Removed: • Seek strategic relationship opportunities with health care systems looking to develop and/or enhance their ambulatory surgery footprint to better meet the needs of the patients and medical staff.
+Added: • Seek strategic relationship opportunities with health care systems looking to develop and/or enhance their ambulatory surgery footprint to better meet the needs of their patients and medical staff.
In addition, we believe favorable industry trends such as an aging population, advancements in medical technology and payor and government encouragement to move high acuity procedures from acute care to our lower cost sites of care will further drive growth.
4 unchanged sentences
In addition, we believe that approximately $60 billion of inpatient surgical cases have the potential to move to outpatient surgery centers, which, together with procedures performed at hospital outpatient departments and ASCs, represents what we believe is a total addressable market of approximately $150 billion.
−Removed: During 2023 and 2022, we operated in two reporting segments:
−Removed: Surgical Facility Services and Ancillary Services.
−Removed: • Our Surgical Facility Services segment consisted of the operation of ASCs and surgical hospitals and includes our anesthesia services.
+Added: During 2024 and 2023, we operated in one reportable segment, Surgical Facilities, which includes the operation of ASCs, surgical hospitals, anesthesia services, urgent care facilities and multi-specialty physician practices.
Our surgical facilities primarily provide non-emergency surgical procedures across many specialties, including, among others, orthopedics and pain management, ophthalmology, gastroenterology ("GI") and general surgery.
−Removed: • Our Ancillary Services segment consisted of multi-specialty physician practices, including physician practices owned and operated pursuant to long-term management service agreements.
−Removed: Surgical Facility Services Segment
−Removed: Surgical Facility Operations
+Added: Surgical Facilities
As of December 31, 2024, we owned or operated 161 surgical facilities, including 142 ASCs and 19 licensed surgical hospitals.
−Removed: Our Surgical Facility Services segment contributed approximately 98% of our total revenue in 2023, and 97% of our total revenue in each of 2022 and 2021.
+Added: Our Surgical Facilities contributed substantially all of our total revenue in 2024, 2023 and 2022.
Our typical ASC is a free-standing facility that performs planned surgical procedures on an outpatient basis for patients not requiring hospitalization and for whom an overnight stay is not expected after surgery.
1 unchanged sentence
The staff of our ASCs generally includes a center administrator, registered nurses, operating room technicians, as well as other administrative staff.
−Removed: Our surgical hospitals generally are larger than our ASCs and include inpatient hospital rooms and, in certain cases, emergency departments.
−Removed: Our surgical hospitals may also provide services such as diagnostic imaging, laboratory, oncology, pharmacy, physical therapy and wound care.
+Added: Our surgical hospitals primarily focus on providing non-emergency, scheduled surgical procedures, with a focus on less complex, elective surgeries that have shorter recovery times.
+Added: Although some of these facilities may include emergency departments, they are generally not equipped to handle a broad spectrum of patient needs, including critical and traumatic injuries.
We operate both multi-specialty and single-specialty facilities.
4 unchanged sentences
For example, our regional managed care directors assist the local management team at each of our surgical facilities in developing relationships with private insurance payors and negotiating private insurance contracts.
−Removed: Surgical Facility Ownership Structure
+Added: Ownership Structure
We own and operate our surgical facilities through partnerships or limited liability companies with physicians, physician groups and health care systems.
26 unchanged sentences
We receive reimbursement from Medicare for surgical services based on three different payment systems depending on the site of service:
−Removed: hospital inpatient surgical services, hospital outpatient surgical services and outpatient surgical services generally provided in our ASCs.
+Added: outpatient surgical services generally provided in our ASCs, hospital outpatient surgical services and hospital inpatient surgical services.
Medicare Reimbursement - Hospital Inpatient Services
−Removed: Eighteen of our surgical facilities are licensed as hospitals.
+Added: Nineteen of our surgical facilities are licensed as hospitals.
Most inpatient services provided by hospitals are reimbursed by Medicare under the inpatient prospective payment system ("IPPS").
14 unchanged sentences
Hospitals that do not meet the reporting requirements of the Medicare Hospital Outpatient Quality Reporting Program will be subject to a 2.0% payment rate decrease.
−Removed: On November 2, 2023, CMS additionally released final updates to its Medicare Part B drug payment policy for hospitals participating in the 340B drug pricing program.
−Removed: The policy change was included in the OPPS final rule, which outlines the 2024 OPPS payment rates.
−Removed: Under the new policy, Medicare will pay lower rates to all OPPS participating HOPDs for non-drug services.
As a result of legislative changes related to off-campus HOPDs, certain off-campus HOPDs that began billing under the OPPS (or underwent certain changes) on or after November 2, 2015 are no longer paid for most services under the OPPS.
14 unchanged sentences
Annual cost reports required under the Medicare and Medicaid programs are subject to routine governmental audits.
−Removed: These audits may result in adjustments to the amounts ultimately determined to be payable to us under these reimbursement programs.
+Added: These audits may result in adjustments to the amounts ultimately determined to be payable to us under these
+Added: reimbursement programs.
Finalization of these audits often takes several years.
1 unchanged sentence
While ASCs are not currently subject to federal cost reporting requirements, it is possible that such requirements, which could be costly for us, will be implemented by CMS in the future.
−Removed: Ancillary Services Segment
−Removed: Ancillary Services Operations
−Removed: Our portfolio of outpatient surgical facilities is complemented by a suite of ancillary services that we provide to support physicians in providing high quality and cost-efficient patient care.
−Removed: This segment includes multi-specialty physician practices, urgent care facilities and anesthesia services.
−Removed: The Company, physicians and patients benefit from these services through improved clinical efficiency and scheduling, and from incremental revenue associated with retaining fees for these services.
−Removed: Our Ancillary Services segment contributed approximately 2% of our total revenue in 2023 and 3% of our total revenue in each of 2022 and 2021.
−Removed: We employ two models in our network of multi-specialty physician practices.
−Removed: In one model, we wholly own and operate physician practices.
−Removed: For example, in the state of Florida, where the law does not preclude a business corporation from employing physicians, we wholly-own and operate physician practices in several locations throughout the state.
−Removed: In the other model, we operate physician practices pursuant to long-term management service agreements with separate professional corporations that are wholly-owned by physicians.
−Removed: Sources of Revenue
−Removed: The fees charged for services in our Ancillary Services segment depend on a variety of factors, including the type of service provided, the location in which the service is provided and the provider of the service.
−Removed: Service fees are received from both government and private insurance payors.
−Removed: The amounts that we receive in payment for the provision of ancillary services may be adversely affected by market and cost factors as well as other factors over which we have no control, including Medicare, Medicaid and state regulations, cost containment and utilization decisions and reduced reimbursement schedules of private insurance payors.
Acquisition and Development Programs
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These activities generally emphasize the benefits offered by our surgical facilities compared to other facilities in the market, such as the proximity of our surgical facilities to physicians’ offices, the ability to schedule consecutive cases without preemption by inpatient or emergency procedures, the efficient turnaround time between cases, our advanced surgical equipment and our simplified administrative procedures.
−Removed: Although the facility administrator is the primary point of contact, physicians who utilize our
−Removed: surgical facilities are important sources of recommendations to other physicians regarding the benefits of using our surgical facilities.
+Added: Although the facility administrator is the primary point of contact, physicians who utilize our surgical facilities are important sources of recommendations to other physicians regarding the benefits of using our surgical facilities.
Recruiting teams develop a target list of physicians, and we continually review our progress in successfully recruiting additional local physicians.
−Removed: We also market our surgical facilities directly to private insurance payors.
+Added: We also market our surgical facilities directly to private insurance payors via our contracting and credentialing programs.
Payor marketing activities conducted by our corporate office management and facility administrators emphasize the high quality of care, cost advantages and convenience of our surgical facilities, and are focused on making each surgical facility an approved provider under local managed care plans.
7 unchanged sentences
Our revenue fluctuates based on the number of business days in each calendar quarter, because the majority of services provided by physicians in our surgical facilities consist of scheduled procedures and office visits that occur during weekday business hours.
−Removed: In addition, revenue in the fourth quarter could also be impacted by an increased utilization of services due to annual deductibles which are not usually met until later in the year and also as patients utilize their health care benefits before they expire at year-end.
+Added: revenue in the fourth quarter could also be impacted by an increased utilization of services due to annual deductibles which are not usually met until later in the year and also as patients utilize their health care benefits before they expire at year-end.
Human Capital Resources
−Removed: At December 31, 2023, we had approximately 13,500 employees, including approximately 3,000 part-time employees.
+Added: At December 31, 2024, we had approximately 15,000 employees, including full-time and part-time employees.
None of our employees are represented by a collective bargaining agreement.
18 unchanged sentences
We also depend on the available labor pool of semi-skilled and unskilled employees in each of the markets in which we operate.
−Removed: We believe that our employees are vital contributors to our success, and we devote significant resources to recruit and retain our workforce.
−Removed: We strive to recruit and retain a diverse population of employees at all stages of their careers that are reflective of the communities we serve.
−Removed: We are committed to promoting an inclusive culture through diversity of thoughts and backgrounds, recognizing the value these experiences bring to our colleagues, physicians, patients and the communities in which we reside.
−Removed: One of our core values is to promote a culture of diversity and inclusion.
−Removed: We have a Corporate Citizenship and Community Impact Council comprised of employees with diverse backgrounds, experiences or characteristics who share a common interest in improving corporate culture and delivering
−Removed: sustained business results.
−Removed: Our policies prohibit discrimination on the basis of race, sex, religion, color, national or ethnic origin, age, disability, sexual orientation, gender identity, gender expression, military service, pregnancy, physical or mental disabilities, genetic information, or any other class protected by applicable law in its administration of policies, programs or employment.
+Added: We believe our colleagues are vital contributors to our success.
+Added: We devote significant resources to attract, develop, retain and accelerate our workforce.
+Added: We strive to live all our values, including demonstrating compassion and kindness in all that we do.
+Added: We are committed to promoting an inclusive and kind culture through diversity of thoughts and backgrounds, recognizing the value these experiences bring to our colleagues, physicians, patients and communities.
+Added: We believe this creates an engaged workforce that feels a sense of belonging in the wonderful work they carry out for patients and communities alongside colleagues and providers.
Environmental
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In those situations, commonly known as "out-of-network" services, we generally charge the patients the same co-payment or other patient responsibility amounts that we would have charged had we had a contract with the private insurance payor.
−Removed: We also submit a claim for the services to the private insurance payor along with full disclosure that we have charged the patient an in-network patient responsibility amount.
+Added: We also submit a
+Added: claim for the services to the private insurance payor along with full disclosure that we have charged the patient an in-network patient responsibility amount.
Governmental Regulation
2 unchanged sentences
The imposition of these regulatory requirements may have the effect of increasing operating costs and reducing the profitability of our operations.
−Removed: Continuing Obligations with Respect to COVID-19 Regulatory Responses
−Removed: Numerous legislative and regulatory actions were taken in an attempt to provide businesses, including health care providers, with relief from the negative impacts of the COVID-19 pandemic.
−Removed: Specifically, the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”), which was signed into law on March 27, 2020, introduced a number of temporary regulatory waivers for healthcare operations and appropriated more than $100 billion in federal funding toward healthcare provider operations through the creation of Provider Relief Fund.
−Removed: Subsequent legislation, such as the December 2020 COVID-19 Economic Relief Bill, further clarified how funds issued under the CARES Act could or could not be used by healthcare providers.
−Removed: The underlying terms and conditions of grant funds received through the CARES Act and other COVID-19-related governmental assistance programs included auditing and reporting requirements.
−Removed: Recipients of program funds were expected to report the ultimate disposition of all funds received in accordance with the CARES Act – or return the funds if unused.
−Removed: Reporting periods for various tranches of funding issued to providers throughout the public health emergency continue in calendar year 2024.
−Removed: Some but not all of our facilities received COVID-19 related funding.
−Removed: Where applicable, our facilities have worked to materially comply with all auditing and reporting requirements to which they become subject as a result of funding received.
−Removed: For more information, please refer to Note 1.
−Removed: "Organization and Summary of Accounting Policies - Medicare Accelerated Payments and Deferred Government Grants" to our audited consolidated financial statements for the year ended December 31, 2023 included elsewhere herein.
−Removed: Waivers or Temporary Suspension of Certain Regulatory Requirements
−Removed: In addition to the financial and other relief that has been provided by the federal government through the CARES Act and other legislation that has been passed by Congress, CMS and many state governments issued a number of waivers and temporary suspensions of
−Removed: health care facility licensure, certification, and reimbursement requirements in order to provide hospitals, ASCs, physicians, and other health care providers with increased flexibility to meet the challenges presented by the COVID-19 public health emergency.
−Removed: Many states also suspended the enforcement of certain regulatory requirements to ensure that health care providers have sufficient capacity to treat COVID-19 patients.
−Removed: With the expiration of the public health emergency, further discussed in the following section, these temporary regulatory changes have terminated and all regulatory requirements have been reinstated in all material respects.
−Removed: Expiration of Public Health Emergency
−Removed: On May 11, 2023, the Biden Administration formally ended the COVID-19 public health emergency.
−Removed: As a result of the expiration of the public health emergency, many Medicare and Medicaid waivers and broad flexibilities previously deemed necessary to expand healthcare system capacity and to allow the health care system to weather the heightened strain created by COVID-19 ended.
−Removed: To the extent any short-term changes in operations were implemented at our facilities in reliance on the COVID-19 waivers, such operations ceased and facilities largely returned to their pre-pandemic operating models.
−Removed: Though the public health emergency has ended, we cannot provide any certainty regarding the long-term impacts of the COVID-19 pandemic on public health and the economy, or whether there will be a resurgence of COVID-19 or a similar virus in the future.
−Removed: Likewise, we are unable to predict the actions of public health agencies that regulate our facilities in response to any future pandemic and how such actions may impact our future operations.
Certificates of Need, Licensure and Accreditation
Capital expenditures for the construction of new health care facilities, the addition of beds or new health care services or the acquisition of existing health care facilities may be reviewable by state regulators under statutory programs that are sometimes referred to as certificate of need laws.
−Removed: States with certificate of need laws place limits on the construction and acquisition of health care facilities and the expansion of existing facilities and services.
+Added: States with certificate of need laws restrict or otherwise require prior authorization for the construction and acquisition of health care facilities and the expansion of existing facilities and services.
In these states, approvals, generally known as certificates of need, are required for capital expenditures exceeding certain preset monetary thresholds for the development, acquisition and/or expansion of certain facilities or services, including, in certain of these states, surgical facilities.
1 unchanged sentence
We currently operate in 22 states that have certificate of need laws.
−Removed: Our surgical facilities also are subject to state licensing requirements for medical providers.
−Removed: Our ASCs have licenses to operate as required in the states in which they operate and must meet all applicable requirements for ASCs.
−Removed: In addition, even though our surgical facilities that are licensed as hospitals primarily provide surgical services, they must meet all applicable requirements for general hospital licensure.
−Removed: To assure continued compliance with these regulations, governmental and other authorities periodically inspect our surgical facilities.
−Removed: The failure to comply with these regulations could result in the suspension or revocation of a facility’s license.
+Added: Our surgical facilities are subject to state licensing requirements.
+Added: Although our surgical hospitals primarily or exclusively provide surgical services, they must meet all applicable requirements for general hospital licensure.
In addition, based on the specific operations of our surgical facilities, some of these facilities maintain a pharmacy license, a controlled substance registration, a clinical laboratory certification waiver, and environmental protection permits for biohazards and/or radioactive materials, as required by applicable law.
+Added: The failure to comply with these regulations and applicable licensing requirements could result in the suspension or revocation of a facility’s license.
As of December 31, 2024, the majority of our facilities were accredited by either The Joint Commission or the Accreditation Association for Ambulatory Health Care, two of the major national organizations that establish standards relating to the physical plant, administration, quality of patient care and operation of medical staffs of various types of health care facilities.
3 unchanged sentences
Failure to maintain accreditation would cause a facility to become subject to state survey agency oversight and potentially subject to increased scrutiny by CMS, and could result in a loss of payment from private insurance health plans.
−Removed: Executive Order
−Removed: On July 9, 2021, President Biden issued an executive order that is intended to promote competition in the U.S.
−Removed: Among other things, the executive order encourages the Federal Trade Commission ("FTC") to ban or limit non-compete agreements, encourages the U.S.
−Removed: Department of Justice ("DOJ") and the FTC to review and revise their merger guidelines to ensure that patients are not harmed by healthcare mergers, and instructs HHS to support existing price transparency rules and implement the legislation adopted to address surprise billing.
−Removed: We cannot predict how, if at all, the various initiatives set forth in the executive order will be implemented by the regulatory agencies involved or the impact that the executive order will have on operations.
−Removed: We note, however, a number of recent policy statements as of December 2023 issued by these federal agencies addressing perceived issues of anti-competitiveness, as well as an uptick in enforcement actions targeting alleged anti-competitiveness.
Affordable Care Act Repeal Efforts
−Removed: Initiatives to repeal or modify the Patient Protection and Affordable Care Act (the "Affordable Care Act") have been persistent over the past several years.
−Removed: As of December 31, 2023, legislative efforts to repeal and replace the Affordable Care Act in full have not been successful.
−Removed: However, as a result of the enactment of the Tax and Jobs Act of 2017, the tax penalty associated with the so-called "individual mandate," which requires most individuals to obtain qualifying health insurance coverage or pay a tax penalty, was reduced to zero starting in 2019.
−Removed: The effective repeal of the individual mandate tax penalty and any other future repeal or replacement of the Affordable Care Act may have significant impact on the reimbursement for health care services generally, and may cause more individuals to become uninsured, rendering them unable to afford our health care services.
−Removed: In 2021, the U.S.
−Removed: Supreme Court dismissed a case that sought to invalidate the
−Removed: Affordable Care Act;
−Removed: however, the Affordable Care Act remains subject to various challenges.
−Removed: Accordingly, there can be no assurance that the adoption of any future federal or state health care reform legislation, or any ruling by a court with respect to the Affordable Care Act, will not have a negative financial impact on the Company.
−Removed: Medicare and Medicaid Private Contractor Audits
−Removed: CMS has implemented a number of programs that use private contractors that contract with CMS to identify overpayments and underpayments and other potential sources of billing fraud.
−Removed: These contractors, known as Recovery Audit Contractors ("RACs") and Zone Program Integrity Contractors ("ZPICs") conduct both post-payment and pre-payment review of claims submitted by Medicare providers.
−Removed: In addition, CMS employs Medicaid Integrity Contractors ("MICs") to perform post-payment audits of Medicaid claims and identify overpayments.
−Removed: Our facilities and providers periodically receive letters from auditors such as RACs and ZPICs requesting repayment of alleged overpayments for services and incur expenses associated with responding to and appealing these determinations, as well as the costs of repaying any overpayments.
−Removed: Moreover, in recent years, the increase in Medicare payment appeals has created a backlog such that resolving appeals often takes multiple years.
−Removed: Although all other repayments requested to date as a result of RAC, MIC and ZPIC audits have not been material to our Company, we are unable to quantify the aggregate financial impact of these audits on our facilities given the pending appeals and uncertainty about the extent of future audits.
+Added: Initiatives to repeal or modify the Patient Protection and Affordable Care Act (the "Affordable Care Act") have persisted over the past several years.
+Added: As an example, the Tax and Jobs Act of 2017 effectively eliminated the tax penalty associated with the so-called "individual mandate," which required most individuals to obtain qualifying health insurance coverage or pay a tax penalty.
+Added: As of December 31, 2024, however, further legislative efforts to repeal and replace the Affordable Care Act in full have not been successful.
+Added: Nevertheless, we are unable to guarantee that future efforts, such as the adoption of any future federal or state health care reform legislation, or any ruling by a court with respect to the Affordable Care Act, will not have a negative financial impact on the Company.
Medicare and Medicaid Participation
−Removed: The majority of our revenue is expected to continue to be received from third-party payors, including federal and state programs, such as Medicare and Medicaid, and private insurance payors.
−Removed: To participate in the Medicare program and receive Medicare payment, our surgical facilities must comply with regulations promulgated by HHS.
−Removed: Among other things, these regulations, known as "conditions for coverage" or "conditions of participation," impose numerous requirements on our facilities, their equipment, their personnel and their standards of medical care, as well as compliance with all applicable state and local laws and regulations.
−Removed: In 2007, CMS issued a policy memorandum (the "2007 CMS Policy Memorandum") that reaffirmed its prior interpretation of its conditions of participation that all hospitals (other than critical access hospitals) participating in the Medicare program are required to provide basic emergency care interventions regardless of whether or not the hospital maintains an emergency department.
−Removed: Our facilities licensed as hospitals are required to meet this requirement to maintain their participating provider status in the Medicare program.
−Removed: Our hospitals that do not have an emergency room, maintain a protocol for the transfer of patients requiring emergency treatment.
−Removed: While we believe such protocols satisfy CMS requirements, CMS could interpret such protocols to be inconsistent with the 2007 CMS Policy Memorandum, which could jeopardize each facility's participation in the Medicare program.
−Removed: Our surgical facilities must also satisfy the conditions of participation to be eligible to participate in the various state Medicaid programs.
−Removed: The requirements for certification under Medicare and Medicaid are subject to change and, in order to remain qualified for these programs, we may have to make changes from time to time in our facilities, equipment, personnel or services.
−Removed: Although we intend to continue to participate in these reimbursement programs, we cannot ensure that our surgical facilities will continue to qualify for participation.
−Removed: The Affordable Care Act and its associated regulations require a hospital to provide written disclosure of physician ownership interests to the hospital’s patients and on the hospital’s website and in any advertising, along with annual reports to the government detailing such interests.
−Removed: Additionally, hospitals that do not have 24/7 physician coverage are required to inform patients of this fact and receive signed acknowledgment from the patients of the disclosure.
−Removed: A hospital’s provider agreement may be terminated if it fails to provide the required notices.
−Removed: Utilization Review
+Added: The majority of our revenue is derived from third-party payors, including federal and state health care programs, such as Medicare and Medicaid, and private insurance payors.
+Added: Continued participation in these programs, and in particular Medicare, is dependent on our continued compliance with regulations promulgated by HHS.
Federal law contains numerous provisions designed to ensure that services rendered by hospitals to Medicare and Medicaid patients meet professionally recognized standards, are medically necessary and that claims for reimbursement are properly filed.
These provisions include a requirement that a sampling of admissions of Medicare and Medicaid patients must be reviewed by quality improvement organizations, which review the appropriateness of patient admissions and discharges, the quality of care provided, the validity of MS-DRG classifications and the appropriateness of cases of extraordinary length of stay or cost.
−Removed: Quality improvement organizations may deny payment for services provided or assess fines and also have the authority to recommend to HHS that a provider which is in substantial noncompliance with the standards of the quality improvement organization be excluded from participation in the Medicare program.
−Removed: Utilization review is also a requirement of most non-governmental managed care organizations.
+Added: Additionally, CMS has implemented a number of programs that use private contractors that contract with CMS to identify overpayments and underpayments and other potential sources of billing fraud.
+Added: Our facilities and providers periodically receive letters from auditors contracted with CMS requesting repayment of alleged overpayments for services and incur expenses associated with responding to and appealing these determinations, as well as the costs of repaying any overpayments.
+Added: Although all such repayments requested to date have been immaterial, we are unable to quantify the aggregate financial impact of these audits on our facilities given the pending appeals and uncertainty about the extent of future audits.
Federal Anti-Kickback Statute and Medicare Fraud and Abuse Laws
4 unchanged sentences
Civil violations are punishable by fines of up to $50,000 for each violation, as well as damages of up to three times the total amount of remuneration received from the government for health care claims.
−Removed: Because physician-owners of our surgical facilities are in a position to generate referrals to the facilities, the distribution of available cash to those investors could come under scrutiny under the Anti-Kickback Statute.
−Removed: Some courts have held that the Anti-Kickback Statute is violated if one purpose (as opposed to a primary or the sole purpose) of a payment to a provider is to induce referrals.
−Removed: Further, Section 6402(f)(2) of the Affordable Care Act amends the Anti-Kickback Statute by adding a provision to clarify that a person need not have actual knowledge of such section or specific intent to commit a violation of the Anti-Kickback Statute.
−Removed: Because none of these cases involved a joint venture such as those owning and operating our surgical facilities, it is not clear how a court would apply these holdings to our activities.
−Removed: It is clear, however, that a physician’s investment income from a surgical facility may not vary with the number of his or her referrals to the surgical facility.
−Removed: Under regulations issued by the Office of the Inspector General of HHS (the "OIG"), certain categories of activities are deemed not to violate the Anti-Kickback Statute (commonly referred to as the safe harbors).
−Removed: According to the preamble to these safe harbor regulations, the failure of a particular business arrangement to comply with the regulations does not determine whether the arrangement violates the Anti-Kickback Statute.
+Added: Violations may further result in civil monetary penalties and exclusion from state and federal health care programs.
+Added: An arrangement may violate the Anti-Kickback Statute even if only one purpose – as opposed to the primary purpose – of the arrangement is to induce referrals.
+Added: Specific intent to violate the statute is not required for a violation to occur.
+Added: Under regulations issued by the Office of the Inspector General of HHS (the "OIG"), certain types of arrangements involving remuneration are deemed not to violate the Anti-Kickback Statute (commonly referred to as the safe harbors).
The safe harbor regulations outline standards that, if complied with, protect conduct that might otherwise be deemed in violation of the Anti-Kickback Statute.
−Removed: When a transaction or relationship does not fit within a safe harbor, it does not mean that an Anti-Kickback Statute violation has occurred;
−Removed: rather, it means that the facts and circumstances as well as the intent of the parties related to a specific transaction or relationship must be examined to determine whether or not any illegal conduct has occurred.
−Removed: We believe the ownership and operations of our surgical facilities do not fit wholly within any of the safe harbors, but we attempt to structure our ASCs to fit as closely as possible within the safe harbor designed to protect distributions to physician-investors in ASCs who directly refer patients to the ASC and personally perform the procedures at the center as an extension of their practice (the "ASC Safe Harbor").
−Removed: The ASC Safe Harbor protects four categories of investors, including ASCs owned by general surgeons, single-specialty physicians, multi-specialty physicians and hospital/physician joint ventures, provided that certain requirements are satisfied.
−Removed: These requirements include the following:
−Removed: • The ASC must be certified to participate in the Medicare program, and its operating and recovery room space must be dedicated exclusively to the center and not a part of a hospital (although such space may be leased from a hospital if such lease meets the requirements of the safe harbor for space rental).
−Removed: • Each investor must be either (a) a physician who derived at least one-third of his or her medical practice income for the previous fiscal year or 12-month period from performing procedures on the list of Medicare-covered procedures for ASCs, (b) a hospital, or (c) a person or entity not in a position to make or influence referrals to the center, nor to provide items or services to the center, nor employed by the center or any investor.
−Removed: • Unless all physician-investors are members of a single specialty, each physician-investor must perform at least one-third of his or her procedures at the ASC each year.
−Removed: This requirement is in addition to the requirement that the physician-investor has derived at least one-third of his or her medical practice income for the past year from performing procedures.
−Removed: • Physician-investors must have fully informed their referred patients of the physician’s investment.
−Removed: • The terms on which an investment interest is offered to an investor are not related to the previous or expected volume of referrals, services furnished or the amount of business otherwise generated from that investor to the entity.
−Removed: • Neither the ASC nor any other investor nor any person acting on their behalf may loan funds to or guarantee a loan for an investor if the investor uses any part of such loan to obtain the investment interest.
−Removed: • The amount of payment to an investor in return for the investment interest is directly proportional to the amount of the capital investment (including the fair market value of any pre-operational services rendered) of that investor.
−Removed: • All physician-investors, any hospital-investor and the center agree to treat patients receiving benefits or assistance under a federal health care program in a non-discriminatory manner.
−Removed: • All ancillary services performed at the ASC for beneficiaries of federal health care programs must be directly and integrally related to primary procedures performed at the center and may not be billed separately.
−Removed: • No hospital-investor may include on its cost report or any claim for payment from a federal health care program any costs associated with the ASC.
−Removed: • The ASC may not use equipment owned by or services provided by a hospital-investor unless such equipment is leased in accordance with a lease that complies with the Anti-Kickback Statute equipment rental safe harbor and such services are provided in accordance with a contract that complies with the Anti-Kickback Statute personal services and management contract safe harbor.
−Removed: • No hospital-investor may be in a position to make or influence referrals directly or indirectly to any other investor or the center.
−Removed: We believe that the ownership and operations of our surgical facilities will not fully satisfy the ASC Safe Harbor requirements for investment interests in ASCs because, among other things, we or one of our subsidiaries will generally be an investor in and provide management services to each ASC.
−Removed: While we believe our ASCs would nonetheless be found to be compliant with the Anti-Kickback
−Removed: Statute, we cannot assure you that the OIG would view our activities favorably even though we strive to achieve compliance with the remaining elements of this safe harbor.
−Removed: In addition, although we expect each physician-investor to utilize the ASCs as an extension of his or her practice and ask each physician-investor to certify this practice, we cannot assure you that all physician-investors will derive at least one-third of their medical practice income from performing Medicare-covered ASC procedures, perform one-third of their procedures at the centers or inform their referred patients of their investment interests.
+Added: The failure of a particular business arrangement to comply with a safe harbor does not determine whether the arrangement violates the Anti-Kickback Statute.
+Added: Instead, when a transaction or relationship does not fit within a safe harbor, the facts and circumstances as well as the intent of the parties related to a specific transaction or relationship must be examined to determine whether or not any illegal conduct has occurred.
+Added: Physician-owners of our surgical facilities are in a position to generate referrals to the facilities, potentially subjecting the distribution of available cash to those investors to scrutiny under the Anti-Kickback Statute.
+Added: Because the ownership and operations of our surgical facilities may not fit wholly within any of the safe harbors, we attempt to structure our surgical facilities, and in particular our ASCs, to fit as closely as possible within the safe harbor designed to protect distributions to physician-investors in ASCs who directly refer patients to the ASC and personally perform the procedures at the center as an extension of their practice (the "ASC Safe Harbor").
+Added: However, we believe that the ownership and operations of our surgical facilities will not fully satisfy the ASC Safe Harbor requirements for investment interests in ASCs because, among other things, we or one of our subsidiaries will generally be an investor in and provide management services to each ASC.
+Added: While we believe our ASCs would nonetheless be found to be compliant with the Anti-Kickback Statute, we cannot assure you that the OIG would view our activities favorably even though we strive to achieve compliance with the remaining elements of this safe harbor.
+Added: In addition, although we expect each physician-investor to utilize the ASCs as an extension of his or her practice and ask each physician-investor to certify this practice, we cannot assure you that all physician-investors will do so in a manner consistent with the requirements of the ASC Safe Harbor.
Interests in our ASC joint ventures are purchased at what we believe to be fair market value.
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07-05 (June 19, 2007), raised concerns that (a) purchases of interests from physicians might yield gains on investment rather than capital infusion to the ASCs, (b) such purchases could be meant to reward or influence the selling physicians’ referrals to the ASC or the hospital, and (c) such returns might not be directly proportional to the amount of capital invested.
−Removed: In OIG Advisory Opinion No.
−Removed: 09-09 (July 29, 2009), the OIG concluded that an arrangement involving an ASC joint venture between a hospital and physicians involving the combination of their two ASCs into a single, larger ASC presented minimal risk of fraud or abuse, despite the fact that it did not fit within any applicable Anti-Kickback safe harbors.
−Removed: Additionally, the OIG stated that fair market value should be determined based only on the tangible assets of each ASC since the physician investors are referral sources for the ASC.
−Removed: The OIG stated that a cash flow-based valuation of the business contributed by the physician investors potentially would include the value of the physician investors’ referrals over the time that their ASC was in existence prior to the merger with the hospital’s ASC.
−Removed: The OIG went on to note that a valuation involving intangible assets would not necessarily result in a violation of the Anti-Kickback Statute, but would require a review of all the facts and circumstances.
−Removed: It is not clear whether the OIG is concerned about using a cash flow-based valuation in most health care transactions involving referral sources, or just transactions where the parties’ contributions would be valued differently for contributing the same assets if only one party’s contribution is valued as a going concern based on cash flow.
−Removed: Also, the OIG appears to be focused on historical cash flow rather than a projected, discounted cash flow, which is a commonly used valuation methodology.
−Removed: Our hospital investments do not fit wholly within the safe harbor for investments in small entities because certain of the investment interests are held by investors who are either in a position to refer to the hospital or who provide services to the hospital and a portion of the hospital’s gross revenues are derived from referrals generated by those investors.
−Removed: However, we believe we comply with the remaining elements of the safe harbor.
−Removed: In addition to the physician ownership in our surgical facilities, other financial relationships of ours with potential referral sources could potentially be scrutinized under the Anti-Kickback Statute.
+Added: For similar reasons, our hospital investments do not fit wholly within the safe harbor for investments in small entities because certain of the investment interests are held by investors who are either in a position to refer to the hospital or who provide services to the hospital and because the hospital’s gross revenues are derived from referrals generated by those investors.
+Added: However, we believe our surgical facilities comply with the remaining elements of their respective safe harbors.
+Added: Our financial relationships with potential referral sources could potentially be scrutinized under the Anti-Kickback Statute.
We have entered into management agreements to manage the majority of our surgical facilities and physician practices.
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Certain of our ASCs have entered into arrangements for professional services, including arrangements for anesthesia services.
−Removed: In a Special Advisory Bulletin issued in April 2003, the OIG focused on "questionable" contractual arrangements where a health care provider in one line of business (the "Owner") expands into a related health care business by contracting with an existing provider of a related item or service (the "Manager/Supplier") to provide the new item or service to the Owner’s existing patient population, including federal health care program patients (so called "suspect Contractual Joint Ventures").
+Added: In a Special Advisory Bulletin issued in April 2003, the OIG focused on "questionable" contractual arrangements where a health care provider in one line of business (the "Owner") expands into a related health care business by contracting with an existing provider of a related item or service (the "Manager/Supplier") to provide the new item or service to the Owner’s existing patient population, including federal health
+Added: care program patients (so called "suspect Contractual Joint Ventures").
The Manager/Supplier not only manages the new line of business, but may also supply it with inventory, employees, space, billing, and other services.
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The OIG might take the position that the failure of the physician investors to enter into similar guarantees represents a special benefit to the physician investors given to induce patient referrals and that such failure constitutes a violation of the Anti-Kickback Statute.
−Removed: We believe that the management fees (and
−Removed: in some cases guarantee fees) are adequate compensation to us for the credit risk associated with the guarantees and that the failure of the physician investors to enter into similar guarantees does not create a material risk of violating the Anti-Kickback Statute.
+Added: We believe that the management fees (and in some cases guarantee fees) are adequate compensation to us for the credit risk associated with the guarantees and that the failure of the physician investors to enter into similar guarantees does not create a material risk of violating the Anti-Kickback Statute.
However, the OIG has not issued any guidance in this regard.
−Removed: The OIG is authorized to issue advisory opinions regarding the interpretation and applicability of the Anti-Kickback Statute, including whether an activity constitutes grounds for the imposition of civil or criminal sanctions.
−Removed: We have not, however, sought such an opinion regarding any of our arrangements.
−Removed: If it were determined that our activities, or those of our surgical facilities or hospitals, violate the Anti-Kickback Statute, we, our subsidiaries, our officers, our directors and each surgical facility and hospital investor could be subject, individually, to substantial monetary liability, prison sentences and/or exclusion from participation in any health care program funded in whole or in part by the U.S.
−Removed: government, including Medicare, Medicaid, TRICARE or state health care programs.
−Removed: Evolving interpretations of current, or the adoption of new, federal or state laws or regulations, such as the Eliminating Kickbacks in Recovery Act (discussed below), could affect many of our arrangements.
+Added: Evolving interpretations of current, or the adoption of new, federal or state laws or regulations could affect many of our arrangements.
Law enforcement authorities, including the OIG, the courts and Congress, are increasing their scrutiny of arrangements between health care providers and potential referral sources to ensure that the arrangements are not designed as a mechanism to exchange remuneration for patient care referrals or opportunities.
Investigators have also demonstrated a willingness to look behind the formalities of a business transaction to determine the underlying purposes of payments between health care providers and potential referral sources.
−Removed: On November 20, 2020, CMS and the OIG issued final rules that modify the federal physician self-referral law, or Stark Law, regulations and the federal anti-kickback and civil monetary penalty for beneficiary inducement statutes and regulations.
−Removed: The intent of the final rules is to reduce over-burdensome and unnecessary regulatory barriers to value-based compensation models and accelerate the transformation of the health care system into one that better promotes the coordination of care among providers.
−Removed: Among other things, the final rules create new anti-kickback and beneficiary inducement statute safe harbors and Stark Law exceptions for certain value based arrangements and arrangements that involve the donation of cybersecurity technology.
−Removed: In addition, the final rules provide additional guidance on several key compliance requirements, including fair market value and commercial reasonableness, that must be met in order for physicians and health care providers to comply with the Stark Law.
−Removed: Eliminating Kickbacks in Recovery Act
−Removed: In addition to the Anti-Kickback Statute, in 2018, the U.S.
−Removed: enacted the Eliminating Kickbacks in Recovery Act (the "EKRA").
−Removed: The EKRA is contained within the broader Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the "SUPPORT Act").
−Removed: The EKRA creates a new federal crime for knowingly and willfully:
−Removed: soliciting or receiving any remuneration in return for referring a patient to a recovery home, clinical treatment facility, or laboratory;
−Removed: or paying or offering any remuneration to induce such a referral or in exchange for an individual using the services of a recovery home, clinical treatment facility, or laboratory.
−Removed: Each conviction under the EKRA is punishable by up to $200,000 in monetary damages, imprisonment for up to ten (10) years, or both.
−Removed: Unlike the Anti-Kickback Statute, the EKRA is not limited to services reimbursable under a government health care program.
−Removed: While the SUPPORT Act targets substance abuse disorder prevention and recovery, the scope of EKRA is not limited to substance abuse drug testing (only one service line of a multitude provided by labs), and therefore it appears to prohibit payment for any patient referral to any laboratory for any service, unless an exception applies.
−Removed: While the EKRA does contain certain exceptions similar to the Anti-Kickback Statute Safe Harbors, those exceptions are more narrow than the Anti-Kickback Statute Safe Harbors.
Federal Physician Self-Referral Law
−Removed: The Stark Law prohibits certain self-referrals for health care services.
−Removed: The Stark Law prohibits a practitioner, including a physician, dentist or podiatrist, from referring patients to an entity with which the practitioner or a member of his or her immediate family has a "financial relationship" for the provision of certain "designated health services" that are paid for in whole or in part by Medicare or Medicaid unless an exception applies.
+Added: The federal physician self-referral law (the "Stark Law") prohibits physicians (as well as chiropractors, optometrists, dentists and podiatrists) from referring patients to an entity with which the practitioner or a member of his or her immediate family has a "financial relationship" for the provision of certain "designated health services" that are paid for in whole or in part by Medicare or Medicaid unless an exception applies.
"Designated health services" include inpatient and outpatient hospital services, clinical laboratory services and radiology services.
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If legislation or regulations are implemented that prohibit physicians from referring patients to surgical facilities in which the physician has a beneficial interest, our business and financial results could be materially adversely affected.
−Removed: The Stark Law currently includes the Whole Hospital Exception, which applies to physician ownership of a hospital, provided such ownership is in the whole hospital and the physician is authorized to perform services at the hospital.
−Removed: We believe that physician
−Removed: investments in our facilities licensed as hospitals meet this requirement.
−Removed: However, certain changes to the Whole Hospital Exception were made by the Affordable Care Act including:
−Removed: • a prohibition on hospitals from having any physician ownership unless the hospital already had physician ownership and a Medicare provider agreement in effect as of December 31, 2010;
−Removed: • a limitation on the percentage of total physician ownership or investment interests in the hospital or entity whose assets include the hospital to the percentage of physician ownership or investment as of March 23, 2010;
−Removed: • a prohibition from expanding the number of beds, operating rooms, and procedure rooms for which it is licensed after March 23, 2010, unless the hospital obtains an exception from the Secretary of the Department of Health & Human Services (the "Secretary");
−Removed: • a requirement that return on investment be proportionate to the investment by each investor;
−Removed: • restrictions on preferential treatment of physician versus non-physician investors;
−Removed: • a requirement for written disclosures of physician ownership interests to the hospital’s patients and on the hospital’s website and in any advertising, along with annual reports to the government detailing such interests;
−Removed: • a prohibition on the hospital or other investors from providing financing to physician investors;
−Removed: • a requirement that any hospital that does not have 24/7 physician coverage inform patients of this fact and receive signed acknowledgments from the patients of the disclosure;
−Removed: • a prohibition on "grandfathered" status for any physician owned hospital that converted from an ASC to a hospital on or after March 23, 2010.
−Removed: We cannot predict whether other proposed amendments to the Whole Hospital Exception will be included in any future legislation, including a repeal of the Affordable Care Act, or if Congress will adopt any similar provisions that would prohibit or otherwise restrict physicians from holding ownership interests in hospitals.
+Added: The Stark Law currently includes the Whole Hospital Exception, as modified by the Affordable Care Act, which governs physician ownership of a hospital and requires, among other things, that such ownership is in the whole hospital, the physician is authorized to perform services at the hospital, and the ownership predates December 31, 2010.
+Added: We believe that physician investments in our facilities licensed as hospitals meet the requirements of the Whole Hospital Exception.
+Added: We cannot predict whether amendments to the Whole Hospital Exception will be included in any future legislation, including a repeal of the Affordable Care Act, or if Congress will adopt any similar provisions that would prohibit or otherwise restrict physicians from holding ownership interests in hospitals.
Any such changes could have an adverse effect on our financial condition and results of operations.
−Removed: In 2010, CMS issued a "self-referral disclosure protocol" for hospitals and other providers that wish to self-disclose potential violations of the Stark Law to CMS and to attempt to resolve those potential violations and any related overpayment liabilities at levels below the maximum penalties and amounts set forth in the statute.
−Removed: In addition to the physician ownership in our surgical facilities, we have other financial relationships with potential referral sources that potentially could be scrutinized under the Stark Law.
−Removed: We have entered into personal service agreements, such as medical director agreements, with physicians at our surgical hospitals and physician owners within our physician practices may make referrals for certain designated health services within their physician practices.
−Removed: We believe that our agreements with referral sources satisfy the requirements of the personal service arrangements exception and that our physician practices satisfy the physician services and in-office ancillary services exceptions to the Stark Law and have implemented formal compliance programs designed to ensure continued compliance.
−Removed: However, we cannot assure you that the OIG or CMS would find our compliance programs to be adequate or that our agreements with referral sources would be found to comply with the Stark Law.
−Removed: Other Fraud and Abuse Laws
−Removed: The Medicare Patient and Program Protection Act of 1987, as amended by the Health Insurance Portability and Accountability Act of 1996, ("HIPAA"), and the Balanced Budget Act of 1997, impose civil monetary penalties and exclusion from state and federal health care programs on providers who commit violations of fraud and abuse laws.
−Removed: HIPAA authorizes the Secretary, and in some cases requires the Secretary, to exclude individuals and entities that the Secretary determines have "committed an act" in violation of applicable fraud and abuse laws or improperly filed claims in violation of such laws from participating in any federal health care program.
−Removed: HIPAA also expanded the Secretary’s authority to exclude a person involved in fraudulent activity from participating in a program providing health benefits, whether directly or indirectly, in whole or in part, by the U.S.
−Removed: Additionally, under HIPAA, individuals who hold a direct or indirect ownership or controlling interest in an entity that is found to violate these laws may also be excluded from Medicare and Medicaid and other federal and state health care programs if the individual knew or should have known, or acted with deliberate ignorance or reckless disregard of, the truth or falsity of the information of the activity leading to the conviction or exclusion of the entity, or where the individual is an officer or managing employee of such entity.
−Removed: This standard does not require that specific intent to defraud be proven by OIG.
−Removed: Under HIPAA it is also a crime to defraud any commercial health care benefit program.
+Added: State Regulation
+Added: Many of the states in which our surgical facilities operate have adopted statutes and/or regulations that prohibit the payment of kickbacks or any type of remuneration in exchange for patient referrals and that prohibit health care providers from, in certain circumstances, referring a patient to a health care facility in which the provider has an ownership or investment interest.
+Added: While these statutes generally mirror the federal Anti-Kickback Statute and Stark Law, they vary widely in their scope and application.
+Added: Some are specifically limited to health care services that are paid for in whole or in part by the Medicaid program;
+Added: others apply to all health care services regardless of payor;
+Added: and others apply only to state-defined designated services, which may differ from the designated health services under the Stark Law.
+Added: In addition, many states have adopted statutes that mirror the False Claims Act and that prohibit the filing of a false or fraudulent claim with a state governmental agency.
+Added: We intend to comply with all applicable state health care laws, rules and regulations.
+Added: However, these laws, rules and regulations have typically been the subject of limited judicial and regulatory interpretation.
+Added: a result, we cannot assure you that our surgical facilities will not be investigated or scrutinized by the governmental authorities empowered to do so or, if challenged, that their activities would be found to be lawful.
+Added: A determination of non-compliance with the applicable state health care laws, rules, and regulations could subject our surgical facilities to civil and criminal penalties and could have a material adverse effect on our operations.
Federal and State Privacy and Security Requirements
−Removed: We are subject to HIPAA, including the Health Information Technology for Economic and Clinical Health Act (the "HITECH Act"), which was enacted as part of The American Recovery and Reinvestment Act of 2009.
+Added: We are subject to the Medicare Patient and Program Protection Act of 1987, as amended by the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), including the Health Information Technology for Economic and Clinical Health Act (the "HITECH Act"), which was enacted as part of The American Recovery and Reinvestment Act of 2009.
The HITECH Act strengthened the requirements and significantly increased the penalties for violations of the HIPAA privacy and security regulations.
−Removed: In 2013, HHS issued the HIPAA Omnibus Rule, which became effective on March 26, 2013.
−Removed: The HIPAA Omnibus Rule requires us to notify patients of any unauthorized access, acquisition, or disclosure of their unsecured protected health information in all situations except those in which we can demonstrate
−Removed: that there is a low probability that the protected health information has been compromised.
−Removed: We have the burden of demonstrating through a risk assessment that a breach of protected health information has not occurred.
The HIPAA privacy standards apply to individually identifiable information held or disclosed by a covered entity in any form, whether communicated electronically, on paper or orally.
−Removed: These standards impose extensive administrative requirements on us.
These standards require our compliance with rules governing the use and disclosure of this health information.
−Removed: They create rights for patients in their health information, such as the right to amend their health information, and they require us to impose these rules, by contract, on any business associate to whom we disclose such information in order to perform functions on our behalf.
+Added: They create rights for patients in their health information and they require us to impose these rules, by contract, on any business associate to whom we disclose such information in order to perform functions on our behalf.
The HIPAA security standards require us to establish and maintain reasonable and appropriate administrative, technical and physical safeguards to ensure the integrity, confidentiality and the availability of electronic protected health and related financial information.
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However, a single breach incident can result in violations of multiple requirements, resulting in possible penalties well in excess of $1.5 million.
−Removed: Under the HITECH Act, HHS is required to conduct periodic compliance audits of covered entities and their business associates.
−Removed: The HITECH Act and the HIPAA Omnibus Rule also extend the application of certain provisions of the security and privacy regulations to business associates and subjects business associates to civil and criminal penalties for violation of the regulations.
−Removed: The HITECH Act authorizes State Attorneys General to bring civil actions seeking either an injunction or damages in response to violations of HIPAA privacy and security regulations or the new data breach law that affects the privacy of their state residents.
+Added: The HITECH Act authorizes State Attorneys General to bring civil actions seeking either an injunction or damages in response to violations of HIPAA privacy and security regulations.
We expect vigorous enforcement of the HITECH Act’s requirements by HHS and State Attorneys General.
HHS has allocated increased funding towards HIPAA enforcement activity and such enforcement activity has seen a marked increase over recent years.
−Removed: We cannot predict whether our surgical facilities will be able to comply with the final rules and the financial impact to our surgical facilities in implementing the requirements under the final rules when they take effect, or whether our surgical hospitals will be selected for an audit, or the results of such an audit.
+Added: We cannot predict whether our surgical facilities will be able to comply with future rules and are unable to predict the financial impact to our surgical facilities in implementing the requirements under such rules if and when they take effect.
Our facilities also remain subject to any state laws that relate to privacy or the reporting of data breaches that are more restrictive than the regulations issued under HIPAA and the requirements of the HITECH Act.
For example, various state laws and regulations may require us to notify affected individuals in the event of a data breach involving certain personal information, such as social security numbers, dates of birth and credit card information.
−Removed: HIPAA Administrative Simplification Requirements
−Removed: The HIPAA transaction regulations were issued to encourage electronic commerce in the health care industry.
−Removed: These regulations include standards that health care providers must follow when electronically transmitting certain health care transactions, such as health care claims.
+Added: In response to the increasing number of cyberattacks targeting the healthcare sector, HHS issued a Notice of Proposed Rulemaking on January 6.
+Added: 2025 aimed at enhancing HIPAA security regulations.
+Added: If these proposed regulatory changes are enacted, our surgical facilities will need to comply with the new security standards, potentially incurring significant costs to implement necessary changes.
Emergency Medical Treatment and Active Labor Act
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We believe that our surgical hospitals comply with EMTALA.
−Removed: State Regulation
−Removed: Many of the states in which our surgical facilities operate have adopted statutes and/or regulations that prohibit the payment of kickbacks or any type of remuneration in exchange for patient referrals and that prohibit health care providers from, in certain circumstances, referring a patient to a health care facility in which the provider has an ownership or investment interest.
−Removed: While these statutes generally mirror the federal Anti-Kickback Statute and Stark Law, they vary widely in their scope and application.
−Removed: Some are specifically limited to health care services that are paid for in whole or in part by the Medicaid program;
−Removed: others apply to all health care
−Removed: services regardless of payor;
−Removed: and others apply only to state-defined designated services, which may differ from the designated health services under the Stark Law.
−Removed: In addition, many states have adopted statutes that mirror the False Claims Act and that prohibit the filing of a false or fraudulent claim with a state governmental agency.
−Removed: We intend to comply with all applicable state health care laws, rules and regulations.
−Removed: However, these laws, rules and regulations have typically been the subject of limited judicial and regulatory interpretation.
−Removed: As a result, we cannot assure you that our surgical facilities will not be investigated or scrutinized by the governmental authorities empowered to do so or, if challenged, that their activities would be found to be lawful.
−Removed: A determination of non-compliance with the applicable state health care laws, rules, and regulations could subject our surgical facilities to civil and criminal penalties and could have a material adverse effect on our operations.
−Removed: We are also subject to various state insurance statutes and regulations that prohibit us from submitting inaccurate, incorrect or misleading claims.
−Removed: Many state insurance laws and regulations are broadly worded and could be implicated, for example, if our surgical facilities were to adjust an out-of-network co-payment or other patient responsibility amounts without fully disclosing the adjustment on the claim submitted to the payor.
−Removed: While some of our surgical facilities adjust the out-of-network costs of patient co-payment and deductible amounts to reflect in-network co-payment costs when providing services to patients whose health insurance is covered by a payor with which the surgical facilities are not contracted, our policy is to fully disclose adjustments in the claims submitted to the payors.
−Removed: We believe that our surgical facilities are in compliance with all applicable state insurance laws and regulations regarding the submission of claims.
−Removed: We cannot assure you, however, that none of our surgical facilities’ insurance claims will ever be challenged.
−Removed: If we were found to be in violation of a state’s insurance laws or regulations, we could be forced to discontinue the violative practice, which could have an adverse effect on our financial position and results of operations, and we could be subject to fines and criminal penalties.
−Removed: Fee Splitting;
−Removed: Corporate Practice of Medicine
−Removed: The laws of many states prohibit physicians from splitting fees with non-physicians (i.e., sharing in a percentage of professional fees), prohibit non-physician entities (such as us) from practicing medicine and exercising control over or employing physicians and prohibit referrals to facilities in which physicians have a financial interest.
−Removed: The existence, interpretation and enforcement of these laws vary significantly from state to state.
−Removed: In light of these restrictions, in certain states we facilitate the provision of physician services by maintaining long-term management services agreements through our subsidiaries with affiliated professional contractors, which employ or contract with physicians and other health care professionals to provide physician professional services.
−Removed: Under these arrangements, our subsidiaries perform only non-medical administrative services, do not represent that they offer medical services and do not exercise influence or control over the practice of medicine by the physicians employed by the affiliated professional contractors.
−Removed: Although we believe that the fees we receive from affiliated professional contractors have been structured in a manner that is compliant with applicable fee-splitting laws, it is possible that a government regulator could interpret such fee arrangements to be in violation of certain fee-splitting laws.
−Removed: Future interpretations of, or changes in, these laws might require structural and organizational modifications of our existing relationships, and we cannot assure you that we would be able to appropriately modify such relationships.
−Removed: In addition, statutes in some states could restrict our expansion into those states.
+Added: With respect to our hospitals that do not have an emergency room, those hospitals maintain a protocol for the transfer of patients requiring emergency treatment.
+Added: While we believe such protocols satisfy CMS requirements, we are unable to guarantee that CMS would not interpret such protocols to be inconsistent with EMTALA requirements, potentially jeopardizing each facility's participation in the Medicare program.
Clinical Laboratory Regulation
Our clinical laboratories are subject to federal oversight under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") which extends federal oversight to virtually all clinical laboratories by requiring that they be certified by the federal government or by a federally-approved accreditation agency.
−Removed: CLIA requires that all clinical laboratories meet quality assurance, quality control and personnel standards.
+Added: CLIA requires that all clinical laboratories meet quality assurance, quality control and personnel
Laboratories also must undergo proficiency testing and are subject to inspections.
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The program also includes a mechanism for employees to report, without fear of retaliation, any suspected legal or ethical violations to their supervisors, designated compliance officers in our facilities, our compliance hotline or directly to our corporate compliance office.
−Removed: We believe our compliance
−Removed: program is consistent with standard industry practices.
+Added: We believe our compliance program is consistent with standard industry practices.
However, we cannot provide any assurances that our compliance program will detect all violations of law or protect against qui tam suits or government enforcement actions.
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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.