Legal Aspects of Ambulatory Anesthesia Judith Jurin Semo,
JD
KEYWORDS Legal issues Anesthesiology Ambulatory surgical center Office practice KEY POINTS This article informs anesthesiologists of some of the legal issues they may encounter in connection with ambulatory surgical center–based or office-based practice. The primary legal issues that anesthesiologists face in connection with practice in such settings can be broken down into practice-related issues and ownership-related issues. Given the complexity of legal issues relating to ambulatory anesthesia, anesthesiologists are advised to consult counsel at an early stage so as to understand the issues that may apply to their practice.
In the United States, medical practice is highly regulated and practice at ambulatory surgical centers (ASCs) and physicians’ offices is no exception. The primary legal issues that anesthesiologists face in connection with practice in such settings can be broken down into 2 categories: (1) practice-related issues, and (2) ownershiprelated issues. This chapter provide an overview of these legal issues. Further resources are referenced in the endnotes. PRACTICE-RELATED LEGAL ISSUES
Practice-related legal issues cover a wide range of aspects of practice. They include regulation of clinical practice, legal concerns related to clinical practice, and regulation of practice management, or business matters, including compliance with federal, state, and local regulatory requirements. This chapter provides anesthesiologists with summary information about how this category of legal issues affects their dayto-day practice. Professional Liability
Professional liability, or medical malpractice, is often the first topic that physicians consider when they consider practice-related legal issues. Compliance with professional standards and the applicable standard of care is important in all settings. In
PLLC, 1800 M Street, Northwest, Suite 730 S, Washington, DC 20036, USA E-mail address: [email protected] Anesthesiology Clin 32 (2014) 541–549 http://dx.doi.org/10.1016/j.anclin.2014.02.009 anesthesiology.theclinics.com 1932-2275/14/$ – see front matter Ó 2014 Elsevier Inc. All rights reserved.
542
Semo
ambulatory settings, in which patients stay a shorter length of time than in inpatient facilities and in which there are fewer personnel and equipment resources, certain issues are even more important. Patient selection
Patient section is important in any setting. In the ambulatory setting, patient selection is especially important for multiple reasons, including the shortened stay compared with inpatient facilities. The anesthesiologist needs to consider whether the patient is suited to the ambulatory setting, because surgeons and proceduralists may seek to perform a procedure in a facility they own, or in their office, rather than performing it in a hospital. The anesthesiologist serves as the gatekeeper, and may be held accountable for allowing the procedure to be performed in an ambulatory setting if there is an adverse outcome. Issues can arise due to the patient’s condition, such as unstable patients with multiple comorbidities, and there is the potential for problems to occur during the course of the procedure. In addition, patient selection concerns also relate to discharge of patients to a home environment in which there may be insufficient attention to the possible adverse reactions. Patient selection is not only a professional liability concern; it is also is a matter of regulatory compliance for practice at an ASC. In the US Centers for Medicare & Medicaid Services (CMS) interpretive guidelines relating to the conditions for coverage (CfCs) for ASCs to participate in the Medicare program, CMS commented that even patients classified as ASA (American Society of Anesthesiologists) 3 may not be appropriate candidates for an ASC: As the ASA PS level of a patient increases, the range of acceptable risk associated with a specific procedure or type of anesthesia in an ambulatory setting may narrow. An ASC that employed this classification system in its assessment of its patients might then consider, taking into account the nature of the procedures it performs and the anesthesia used, whether it will accept for admission patients who would have a classification of ASA PS IV or higher. For many patients classified as ASA PS level III, an ASC may also not be an appropriate setting, depending upon the procedure and anesthesia.1 State law also may bear on the patient selection process. For example, Alabama regulations require that “[p]atients must be individually evaluated for each procedure to determine if the office is an appropriate setting for the anesthesia required and for the surgical procedure to be performed.”2 Informed consent
As in the case of patient selection, informed consent is a required element of anesthesia practice in all settings. In connection with ambulatory anesthesia, which covers both ASC and office settings, there may be additional legal requirements to consider in obtaining informed consent from a patient. In particular, the anesthesiologist needs to consider whether there are either (1) additional requirements for the patient’s informed consent to having the procedure and the anesthesia performed in the ASC or office setting, or (2) additional substantive requirements relating to the nature of the informed consent provided. Two examples illustrate the possible additional requirements. First, the CMS CfCs for ASCs to participate in the Medicare program require that patients be given information “needed to make an informed decision about whether to consent to a surgical procedure in the ASC.”3 CMS further requires that the informed consent process provide the patient with information on anesthesia risks and benefits. In describing a
Legal Aspects of Ambulatory Anesthesia
“well-designed” informed consent process, CMS explains that the informed consent process should cover the “material risks and benefits” related to anesthesia, which could include those risks with a high degree of likelihood but a low degree of severity, as well as those with a low degree of likelihood but a high degree of severity.4 Anesthesiologists also need to consider whether state law contains additional requirements relating to informed consent for anesthesia to be performed in the ambulatory setting. For example, Arizona law requires physicians who perform office-based surgery using sedation in an office, non-ASC, or nonhospital setting to obtain informed consent from the patient that “[a]uthorizes the office-based surgery to be performed in the physician’s office.”5 Although this requirement may apply to the surgeon, it is important to consider how it may apply to anesthesiologists who perform officebased anesthesia. Professional association standards
Anesthesiologists practicing in ambulatory and office-based settings should be familiar with professional association standards relating to ambulatory and officebased anesthesia. Compliance with such standards assists in demonstrating compliance with the standard of care. Applicable standards include those of the Society for Ambulatory Anesthesia (such as the Consensus Statement on Preoperative Selection of Adult Patients with Obstructive Sleep Apnea Scheduled for Ambulatory Surgery, and the Guidelines for the Management of Postoperative Nausea and Vomiting) and the ASA (such as the Guidelines for Ambulatory Anesthesia and Surgery and the Guidelines for Office-Based Anesthesia). Regulatory Considerations
Anesthesiologists practicing in ambulatory settings also need to consider legal requirements that apply to their practice. CMS conditions for coverage
The CMS CfCs are requirements for ASCs to participate in the Medicare program. The CMS regulations require that a physician “examine the patient immediately before surgery to evaluate the risk of anesthesia and of the procedure to be performed,”6 and that a physician or anesthetist evaluate the patient before discharge for “proper anesthesia recovery,”7 and they limit the individuals who may administer anesthetics to an anesthesiologist, a certified registered nurse anesthetist (CRNA) or anesthesiologist’s assistant (AA), or a “supervised trainee in an approved educational program.”8 Except in opt-out states (states that have opted out of the physician supervision requirement for CRNAs), the nonphysician anesthetist must be under “the supervision of the operating physician”; an AA must be “under the supervision of an anesthesiologist.”9 The CMS Interpretive Guidelines provide further guidance regarding the regulatory requirements. Several sections of the Interpretive Guidelines relate to anesthesia. The requirements related to anesthetic risk and evaluation are discussed earlier. Other sections of the Interpretive Guidelines outline requirements relating to the requirement of a predischarge evaluation by a physician or anesthetist. The guidelines reference ASA recommendations for routine postanesthesia assessment and monitoring, and reference assessment of the following factors: 1. Respiratory function, including respiratory rate, airway patency, and oxygen saturation 2. Cardiovascular function, including pulse rate and blood pressure 3. Mental status 4. Temperature
543
544
Semo
5. Pain 6. Nausea and vomiting 7. Postoperative hydration10 Because the evaluation must be done by a physician or anesthetist, it is not sufficient for the postanesthesia care unit nurse to monitor and document these indicators. The Interpretive Guidelines also provide additional information on who may administer anesthesia and the supervision requirements.11 State law requirements
Specific requirements relating to administration of anesthesia in ASCs frequently are based on state law. Many states regulate ASCs and, as part of the regulations, outline requirements relating to such matters as who may perform anesthesia; who must perform the preanesthetic assessment; and, in some states, the supervision requirements for nonphysician anesthetists.12 Some states regulate office-based surgery and office-based anesthesia. As noted earlier, Alabama and Arizona both have regulations governing office-based surgery. The Federation of State Medical Boards has assembled information regarding states that regulate office-based surgery13; those rules often contain specific requirements relating to the administration of anesthesia in offices. Kickbacks
The federal antikickback statute14 makes it a criminal offense knowingly and willfully to offer, pay, solicit, or receive any remuneration to induce referrals of items or services that are reimbursable by federal health care programs. “Remuneration” includes the transfer of anything of value, no matter what form the value takes (whether cash, services, or other items of value), and regardless whether it is paid directly or indirectly. Courts have interpreted the statute to cover an arrangement if even 1 purpose of the remuneration is to obtain money (or other value) for the referral of services or to induce further referrals.15 Thus, a transaction can be illegal even if funds are paid for legitimate services, if any purpose of the remuneration is to induce referrals or to pay for referrals. A persistent issue related to anesthesia practice at ASCs and in office-based settings has been the efforts of referring physicians to obtain money or other items of value in order to allow the anesthesiologists to provide services at the ASC or office. These efforts have taken many different forms, including having the anesthesiologists absorb some of the ASC’s or physician’s costs by paying for or providing drugs, equipment, or personnel, or paying for space at the ASC or office. Other efforts have involved so-called “company models” or other structures in which the referring physician’s bill for the anesthesia services that either the anesthesiologists or CRNAs provide, pay the anesthesia personnel some amount for their services, and then retain the balance of the anesthesia professional fee. The legality of many of these arrangements has been the topic of active debate in the legal and medical communities. On June 1, 2012, the Office of Inspector General (OIG) within the Department of Health and Human Services issued an advisory opinion on 2 different proposed arrangements relating to the provision of anesthesia services at ASCs owned by referring physicians or their professional corporations or limited liability companies. The OIG expressed concern that both arrangements might violate the antikickback statute. In the first arrangement, the anesthesiologists were to pay the ASC owners for management services, which were to include preoperative nursing assessments; adequate space for all of the anesthesiologists, including their personal effects; adequate space for the anesthesiologists’ materials, including documentation and
Legal Aspects of Ambulatory Anesthesia
records; and assistance with transferring billing documentation to the anesthesiologists’ billing office. The management services fee was to be payable only on non–federal health care program patients. In the second arrangement, the ASC owners would set up a separate company that would provide anesthesia services to the ASC’s patients. The anesthesiologists would work for the anesthesia company, the referring physicians would bill for their services and pay the anesthesiologists a negotiated rate, and the referring physicians would retain the balance of the professional fees paid for anesthesia services. The OIG first determined that separating the federal health care program patients from payment of the fee did not avoid implicating the antikickback statute, because there was a risk that the anesthesiologists would be paying the management services fees for non–federal health care program patients to induce the referring physicians to refer of all of their patients, including federal health care program patients. It is significant that the ASCs owned by the referring physicians planned to continue to charge a facility fee, which pays for some of the same services that the management services fee was to cover. The OIG expressed concern about the company model arrangement, noting that it “appears that [the arrangement] is designed to permit the Centers’ physician-owners [the referring physicians] to do indirectly what they cannot do directly; that is, to receive compensation, in the form of a portion of the Requestor’s [the anesthesiologists’] anesthesia services revenues, in return for their referrals to the Requestor.”16 Even if the payments to the anesthesiologists could be protected under a so-called safe harbor, a business arrangement that meets regulatory requirements and is not subject to prosecution (discussed later), the retained profit was not subject to such protection. The legality of an arrangement depends on the intent of the parties, so the absence of safe harbor protection does not mean that the arrangement is illegal. The OIG was concerned that the anesthesia company was set up just to provide services to the referring physicians’ own patients, and that the referring physicians would not actually participate in the operation of the anesthesia company, which reflected long-standing concerns of the OIG with “suspect contractual joint ventures.” Advisory opinions apply only to the specific facts outlined in the request for the advisory opinion. Nonetheless, they are viewed as helpful guidance to the industry. The referring physician community is trying to restructure arrangements to conform to the OIG guidance, and the anesthesia community is continuing to seek guidance from federal and state agencies on the legality of these arrangements. Anesthesiologists need to consider whether state law may render arrangements such as the 2 outlined in the OIG advisory opinion and variations on those arrangements unlawful. In particular, state laws barring kickbacks and physician selfreferrals and state laws prohibiting fee-splitting may make such arrangements unlawful. Stark and physician self-referrals
The federal law that limits physician self-referrals, known as Stark II,17 is a civil federal statute, in contrast with the antikickback statute, which is a criminal law. Stark II prohibits physicians from making referrals for designated health services (DHS) to an entity in which they or their immediate family members have a financial interest, either by way of ownership or compensation, unless an exception applies. The law prohibits the entity from billing Medicare, the patient, or a third party payor for the services or goods provided as a result of such a referral. The term DHS includes the following services: (1) clinical laboratory services; (2) physical therapy, occupational therapy, and speech-language pathology
545
546
Semo
services; (3) radiology services, including magnetic resonance imaging, computed axial tomography scans, and ultrasound services; (4) radiation therapy services and supplies; (5) durable medical equipment and supplies; (6) parenteral and enteral nutrients, equipment, and supplies; (7) prosthetics, orthotics, and prosthetic devices and supplies; (8) home health services; (9) outpatient prescription drugs; and (10) inpatient and outpatient hospital services.18 Neither ASC services nor anesthesia services are DHS, so anesthesiologists performing surgical anesthesia services in an ASC or office typically do not refer for DHS. (In contrast, in a hospital setting, anesthesiologists may refer for inpatient or outpatient hospital services in connection with ordering testing of patients.) Pain physicians may refer for certain categories of DHS and may need to consider how Stark affects their practice.19 There is further discussion of how Stark applies to ambulatory anesthesia practice and the exceptions of interest to anesthesiologists in the American Society of Anesthesiologists publication, Ambulatory Surgical Centers: A Manual for Anesthesiologists (chapter VII). Contracts
Contracts and contract interpretation are part of the business of ambulatory anesthesia practice, because anesthesiologists often enter into professional services agreements with ASCs and physician offices. The contracts typically reflect the business terms agreed to by the parties. There is a detailed discussion of contract issues that arise in ASC agreements in the American Society of Anesthesiologists publication, Ambulatory Surgical Centers: A Manual for Anesthesiologists (chapter III). If the ASC or office owners ask the anesthesiologists to provide items or services of value, or require the anesthesiologists to allow the referring physicians or a company they own to bill for the anesthesia services (with the anesthesiologists receiving less than their full professional fees), in exchange for the right to provide services at the ASC or office, the anesthesiologists should consult counsel regarding the legality of the arrangement (discussed earlier). OWNERSHIP-RELATED LEGAL ISSUES
The other category of legal issues relates to who may own an ASC and the regulatory requirements relating to such ownership. Ownership of an office is not regulated for purposes of Medicare and federal health care programs, in large part because Medicare does not pay a facility fee for procedures performed in offices. Federal Antikickback Statute Restrictions on Ownership
The concern with investment interests in ASCs is that the ownership interests might be given to physicians as an inducement for them to refer business to the investment ASC. As noted earlier, the antikickback statute is broad in its prohibition. It prohibits offering or paying, or soliciting or receiving any remuneration that is intended to induce referrals of items or services payable under federal health care programs. That prohibition is broad, so Congress directed the OIG to issue so-called safe harbors; practices that, although potentially capable of inducing referrals of business under federal and state health care programs, are not treated as criminal offenses under the antikickback statute. Because the antikickback statute is intent based, the failure to fit within a safe harbor does not mean that the arrangement is illegal. It does mean that it is necessary to review the transaction to assess whether it violates the antikickback statute.
Legal Aspects of Ambulatory Anesthesia
Given the high degree of interest in physician ownership of ASCs, the OIG promulgated a safe harbor relating to investment interests in ASCs.20 The purpose of the ASC safe harbor is to protect investment interests held by physicians who use the ASC as an extension of their practices. It is focused on surgeons and other physicians who agree to perform no less than one-third of their outpatient procedures at the investment ASC. The safe harbor does not extend to ownership by primary care physicians, because of the concern that ASC ownership by such physicians may be a way to reward them for referrals to surgeons and other investors. In issuing the safe harbor, the OIG stated that it would look for indicia that the ASC investment represents the extension of a physician’s office space, and not a means to profit from referrals.21 Some of the requirements listed later (in particular the requirements related to [1] performance of one-third of the procedures at the investment ASC, and [2] deriving at least one-third of each physician investor’s medical practice income from all sources for the prior fiscal year or prior 12-month period from performance of Medicare-covered procedures [the so-called one-third/one-third test]) are designed to ensure that the investment ASC is an extension of the investing physician’s practice. The safe harbor for ASC investments covers 4 types of ASCs: (1) surgeon-owned ASCs, (2) single-specialty ASCs, (3) multispecialty ASCs, and (4) hospital/physician ASCs. There are detailed requirements pertaining to each type of ASC.22 Investments in multispecialty ASCs are typically the type in which anesthesiologists wish to invest. The requirements for the safe harbor applicable to multispecialty ASCs include the one-third/one-third test noted earlier. (The safe harbors for the 3 other types of ASCs similarly require that all eligible investors derive at least one-third of their individual medical practice incomes from all sources for the prior fiscal year or prior 12-month period from performance of Medicare-covered procedures.) Because anesthesia services are not on the list of procedures,23 anesthesiologists do not meet the requirements of the safe harbor for ASC investments. In contrast, pain medicine physicians may be able to satisfy the one-third/one-third test. As noted earlier, it is not necessary for a transaction to satisfy a safe harbor to be legal. The question is the intent of the parties. Because anesthesiologists do not refer procedures to the investment ASC, an ownership interest is unlikely to be intended as an inducement for the anesthesiologists to refer items or services to the investment ASC. (Pain medicine physicians are in a position to refer cases to an investment ASC, so their situation needs to be assessed separately. As noted earlier, pain medicine physicians may be able to satisfy the one-third/one-third test.) Moreover, to the extent that the one-third/one-third test is intended to ensure that the investment ASC is an extension of the investing physician’s practice, that goal is met in the case of anesthesiologists. Their practice at ASC is an extension of their practice. Anesthesiologists often are given opportunities to invest in ASCs to reward them for their efforts in working hard to make the ASC successful, not for any illegal purpose. In summary, it is not illegal for anesthesiologists to invest in ASCs, but they typically do not satisfy the requirements of the safe harbor for ASC investments. Stark Law Considerations
The Stark law is unlikely to be implicated in connection with an anesthesiologist’s ownership of an ASC. It would be necessary to consider the Stark law issues if the anesthesiologist were to refer to the investment ASC for DHS. In such an unlikely event, it would be necessary to consider what exceptions might apply to cover the ownership interest. Stark law analysis is complex, so anesthesiologists who are
547
548
Semo
concerned with potential Stark issues in connection with ASC practice should consult experienced health law counsel. State Law Requirements
State law may apply to an anesthesiologist’s ownership interest in an ASC. States have passed many types of laws relating to ASC ownership, including the following: Requirements that referring physicians perform the services themselves
Some state laws require physicians investing in health care facilities to perform clinical services at those facilities in order to refer patients to those facilities. Such laws essentially bar self-referrals, although the term “referral” generally does not include a service provided by the referring physician or a member of the referring physician’s group practice. North Carolina is an example of a state with such a self-referral statute.24 Disclosure or sunshine requirements
Some states do not prohibit investments in ASCs. Instead, they require disclosure to the patient of the referring physician’s ownership interest. For example, in Washington State, if a physician owns an interest in an ASC, the physician must provide the following disclosure before referring a patient to that ASC25: 1. Disclose to the patient in writing that the physician has a financial interest in the ASC 2. Provide the patient with a list of effective alternative facilities 3. Inform patients that they have the option to use one of the alternative facilities 4. Assure patients that they will not be treated differently by the referring physician if the patient chooses one of the alternative facilities Anesthesiologists considering an ASC investment should understand the extent to which state law may regulate their practices, based on such ownership interest. Additional information regarding state law governing ASC investments is available in the American Society of Anesthesiologists publication, Ambulatory Surgical Centers: A Manual for Anesthesiologists (chapter VIII). Given the changing nature of state law, anesthesiologists should check for any updates to the laws in the state(s) in which they practice. SUMMARY
This article is intended to sensitize anesthesiologists to some of the legal issues they may encounter in connection with ASC or office-based practice. Given the complexity of legal issues relating to ambulatory anesthesia, anesthesiologists are advised to consult counsel at an early stage so as to understand the issues that may apply to their practices. REFERENCES
1. State operations manual, appendix L, guidance for surveyors: ambulatory surgical centers, section Q-0061, at page 59. Available at: http://www.cms.gov/Regulationsand-Guidance/Guidance/Manuals/downloads/som107ap_l_ambulatory.pdf. Accessed September 2, 2013. 2. ALA. ADMIN. CODE r. 540-X-10-.01(2)(b) (2013). 3. State operations manual, appendix L, guidance for surveyors: ambulatory surgical centers, section Q-0229, at page 133. 4. State operations manual, appendix L, guidance for surveyors: ambulatory surgical centers, section Q-0229, at page 134.
Legal Aspects of Ambulatory Anesthesia
5. 6. 7. 8. 9. 10.
11. 12.
13.
14. 15. 16.
17. 18. 19.
20. 21. 22.
23. 24. 25.
ARIZ. ADMIN. CODE x R4-16-702.A.5. 42 C.F.R. x 416.42(a)(1). 42 C.F.R. x 416.42(a)(2). 42 C.F.R. x 416.42(b)(1) and (2). 42 C.F.R. x 416.42(b)(2). State operations manual, appendix L, guidance for surveyors: ambulatory surgical centers, section Q-0062, at pages 60–1. Available at: http://www.cms.gov/ Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_l_ambulatory. pdf. Accessed September 2, 2013. Id. at section Q-0063, at pages 62–4. A detailed listing of state law requirements regarding administration of anesthesia in ASCs as of 2007 is available in Ambulatory Surgical Centers: A Manual for Anesthesiologists, published by the American Society of Anesthesiologists, at pages 49–55. Available at: http://www.fsmb.org/pdf/grpol_regulation_office_based_surgery.pdf and http://www.fsmb.org/pdf/GRPOL_Office_Based_Surgery_N-Z.pdf. Accessed March 20, 2014. 42 U.S.C. x 1320a-7b(b). United States v. Kats, 871 F.2d 105 (9th Cir. 1989); United States v. Greber, 760 F.2d 68 (3d Cir.), cert. denied, 474 U.S. 988 (1985). OIG, advisory opinion 12-06 (2012), at page 10. Available at: http://oig.hhs.gov/ fraud/docs/advisoryopinions/2012/AdvOpn12-06.pdf. Accessed September 2, 2013. 42 U.S.C. x 1395nn (section 1877 of the Social Security Act). 42 U.S.C. x 1395nn (h)(6); 42 C.F.R. x 411.351. Further discussion of the Stark law appears in Ambulatory Surgical Centers: A Manual for Anesthesiologists, published by the American Society of Anesthesiologists, Chapter VII, at pages 91–115. 64 Fed. Reg. 63, 517 (1999). The ASC safe harbor appears in 42 C.F.R. x 1001.952(r). 64 Fed. Reg. at 63,535–36. Further detail on the specifics of the requirements appears in Ambulatory Surgical Centers: A Manual for Anesthesiologists, published by the American Society of Anesthesiologists, Chapter VI, pages 67–75. The term “procedures” means any procedure(s) on the list of Medicare-covered procedures for ASCs. See 42 C.F.R. x 1001.952(r)(5). N.C. GEN. STAT. x; 90–406. WASH. REV. CODE x 19.68.010(2).
549
JD
KEYWORDS Legal issues Anesthesiology Ambulatory surgical center Office practice KEY POINTS This article informs anesthesiologists of some of the legal issues they may encounter in connection with ambulatory surgical center–based or office-based practice. The primary legal issues that anesthesiologists face in connection with practice in such settings can be broken down into practice-related issues and ownership-related issues. Given the complexity of legal issues relating to ambulatory anesthesia, anesthesiologists are advised to consult counsel at an early stage so as to understand the issues that may apply to their practice.
In the United States, medical practice is highly regulated and practice at ambulatory surgical centers (ASCs) and physicians’ offices is no exception. The primary legal issues that anesthesiologists face in connection with practice in such settings can be broken down into 2 categories: (1) practice-related issues, and (2) ownershiprelated issues. This chapter provide an overview of these legal issues. Further resources are referenced in the endnotes. PRACTICE-RELATED LEGAL ISSUES
Practice-related legal issues cover a wide range of aspects of practice. They include regulation of clinical practice, legal concerns related to clinical practice, and regulation of practice management, or business matters, including compliance with federal, state, and local regulatory requirements. This chapter provides anesthesiologists with summary information about how this category of legal issues affects their dayto-day practice. Professional Liability
Professional liability, or medical malpractice, is often the first topic that physicians consider when they consider practice-related legal issues. Compliance with professional standards and the applicable standard of care is important in all settings. In
PLLC, 1800 M Street, Northwest, Suite 730 S, Washington, DC 20036, USA E-mail address: [email protected] Anesthesiology Clin 32 (2014) 541–549 http://dx.doi.org/10.1016/j.anclin.2014.02.009 anesthesiology.theclinics.com 1932-2275/14/$ – see front matter Ó 2014 Elsevier Inc. All rights reserved.
542
Semo
ambulatory settings, in which patients stay a shorter length of time than in inpatient facilities and in which there are fewer personnel and equipment resources, certain issues are even more important. Patient selection
Patient section is important in any setting. In the ambulatory setting, patient selection is especially important for multiple reasons, including the shortened stay compared with inpatient facilities. The anesthesiologist needs to consider whether the patient is suited to the ambulatory setting, because surgeons and proceduralists may seek to perform a procedure in a facility they own, or in their office, rather than performing it in a hospital. The anesthesiologist serves as the gatekeeper, and may be held accountable for allowing the procedure to be performed in an ambulatory setting if there is an adverse outcome. Issues can arise due to the patient’s condition, such as unstable patients with multiple comorbidities, and there is the potential for problems to occur during the course of the procedure. In addition, patient selection concerns also relate to discharge of patients to a home environment in which there may be insufficient attention to the possible adverse reactions. Patient selection is not only a professional liability concern; it is also is a matter of regulatory compliance for practice at an ASC. In the US Centers for Medicare & Medicaid Services (CMS) interpretive guidelines relating to the conditions for coverage (CfCs) for ASCs to participate in the Medicare program, CMS commented that even patients classified as ASA (American Society of Anesthesiologists) 3 may not be appropriate candidates for an ASC: As the ASA PS level of a patient increases, the range of acceptable risk associated with a specific procedure or type of anesthesia in an ambulatory setting may narrow. An ASC that employed this classification system in its assessment of its patients might then consider, taking into account the nature of the procedures it performs and the anesthesia used, whether it will accept for admission patients who would have a classification of ASA PS IV or higher. For many patients classified as ASA PS level III, an ASC may also not be an appropriate setting, depending upon the procedure and anesthesia.1 State law also may bear on the patient selection process. For example, Alabama regulations require that “[p]atients must be individually evaluated for each procedure to determine if the office is an appropriate setting for the anesthesia required and for the surgical procedure to be performed.”2 Informed consent
As in the case of patient selection, informed consent is a required element of anesthesia practice in all settings. In connection with ambulatory anesthesia, which covers both ASC and office settings, there may be additional legal requirements to consider in obtaining informed consent from a patient. In particular, the anesthesiologist needs to consider whether there are either (1) additional requirements for the patient’s informed consent to having the procedure and the anesthesia performed in the ASC or office setting, or (2) additional substantive requirements relating to the nature of the informed consent provided. Two examples illustrate the possible additional requirements. First, the CMS CfCs for ASCs to participate in the Medicare program require that patients be given information “needed to make an informed decision about whether to consent to a surgical procedure in the ASC.”3 CMS further requires that the informed consent process provide the patient with information on anesthesia risks and benefits. In describing a
Legal Aspects of Ambulatory Anesthesia
“well-designed” informed consent process, CMS explains that the informed consent process should cover the “material risks and benefits” related to anesthesia, which could include those risks with a high degree of likelihood but a low degree of severity, as well as those with a low degree of likelihood but a high degree of severity.4 Anesthesiologists also need to consider whether state law contains additional requirements relating to informed consent for anesthesia to be performed in the ambulatory setting. For example, Arizona law requires physicians who perform office-based surgery using sedation in an office, non-ASC, or nonhospital setting to obtain informed consent from the patient that “[a]uthorizes the office-based surgery to be performed in the physician’s office.”5 Although this requirement may apply to the surgeon, it is important to consider how it may apply to anesthesiologists who perform officebased anesthesia. Professional association standards
Anesthesiologists practicing in ambulatory and office-based settings should be familiar with professional association standards relating to ambulatory and officebased anesthesia. Compliance with such standards assists in demonstrating compliance with the standard of care. Applicable standards include those of the Society for Ambulatory Anesthesia (such as the Consensus Statement on Preoperative Selection of Adult Patients with Obstructive Sleep Apnea Scheduled for Ambulatory Surgery, and the Guidelines for the Management of Postoperative Nausea and Vomiting) and the ASA (such as the Guidelines for Ambulatory Anesthesia and Surgery and the Guidelines for Office-Based Anesthesia). Regulatory Considerations
Anesthesiologists practicing in ambulatory settings also need to consider legal requirements that apply to their practice. CMS conditions for coverage
The CMS CfCs are requirements for ASCs to participate in the Medicare program. The CMS regulations require that a physician “examine the patient immediately before surgery to evaluate the risk of anesthesia and of the procedure to be performed,”6 and that a physician or anesthetist evaluate the patient before discharge for “proper anesthesia recovery,”7 and they limit the individuals who may administer anesthetics to an anesthesiologist, a certified registered nurse anesthetist (CRNA) or anesthesiologist’s assistant (AA), or a “supervised trainee in an approved educational program.”8 Except in opt-out states (states that have opted out of the physician supervision requirement for CRNAs), the nonphysician anesthetist must be under “the supervision of the operating physician”; an AA must be “under the supervision of an anesthesiologist.”9 The CMS Interpretive Guidelines provide further guidance regarding the regulatory requirements. Several sections of the Interpretive Guidelines relate to anesthesia. The requirements related to anesthetic risk and evaluation are discussed earlier. Other sections of the Interpretive Guidelines outline requirements relating to the requirement of a predischarge evaluation by a physician or anesthetist. The guidelines reference ASA recommendations for routine postanesthesia assessment and monitoring, and reference assessment of the following factors: 1. Respiratory function, including respiratory rate, airway patency, and oxygen saturation 2. Cardiovascular function, including pulse rate and blood pressure 3. Mental status 4. Temperature
543
544
Semo
5. Pain 6. Nausea and vomiting 7. Postoperative hydration10 Because the evaluation must be done by a physician or anesthetist, it is not sufficient for the postanesthesia care unit nurse to monitor and document these indicators. The Interpretive Guidelines also provide additional information on who may administer anesthesia and the supervision requirements.11 State law requirements
Specific requirements relating to administration of anesthesia in ASCs frequently are based on state law. Many states regulate ASCs and, as part of the regulations, outline requirements relating to such matters as who may perform anesthesia; who must perform the preanesthetic assessment; and, in some states, the supervision requirements for nonphysician anesthetists.12 Some states regulate office-based surgery and office-based anesthesia. As noted earlier, Alabama and Arizona both have regulations governing office-based surgery. The Federation of State Medical Boards has assembled information regarding states that regulate office-based surgery13; those rules often contain specific requirements relating to the administration of anesthesia in offices. Kickbacks
The federal antikickback statute14 makes it a criminal offense knowingly and willfully to offer, pay, solicit, or receive any remuneration to induce referrals of items or services that are reimbursable by federal health care programs. “Remuneration” includes the transfer of anything of value, no matter what form the value takes (whether cash, services, or other items of value), and regardless whether it is paid directly or indirectly. Courts have interpreted the statute to cover an arrangement if even 1 purpose of the remuneration is to obtain money (or other value) for the referral of services or to induce further referrals.15 Thus, a transaction can be illegal even if funds are paid for legitimate services, if any purpose of the remuneration is to induce referrals or to pay for referrals. A persistent issue related to anesthesia practice at ASCs and in office-based settings has been the efforts of referring physicians to obtain money or other items of value in order to allow the anesthesiologists to provide services at the ASC or office. These efforts have taken many different forms, including having the anesthesiologists absorb some of the ASC’s or physician’s costs by paying for or providing drugs, equipment, or personnel, or paying for space at the ASC or office. Other efforts have involved so-called “company models” or other structures in which the referring physician’s bill for the anesthesia services that either the anesthesiologists or CRNAs provide, pay the anesthesia personnel some amount for their services, and then retain the balance of the anesthesia professional fee. The legality of many of these arrangements has been the topic of active debate in the legal and medical communities. On June 1, 2012, the Office of Inspector General (OIG) within the Department of Health and Human Services issued an advisory opinion on 2 different proposed arrangements relating to the provision of anesthesia services at ASCs owned by referring physicians or their professional corporations or limited liability companies. The OIG expressed concern that both arrangements might violate the antikickback statute. In the first arrangement, the anesthesiologists were to pay the ASC owners for management services, which were to include preoperative nursing assessments; adequate space for all of the anesthesiologists, including their personal effects; adequate space for the anesthesiologists’ materials, including documentation and
Legal Aspects of Ambulatory Anesthesia
records; and assistance with transferring billing documentation to the anesthesiologists’ billing office. The management services fee was to be payable only on non–federal health care program patients. In the second arrangement, the ASC owners would set up a separate company that would provide anesthesia services to the ASC’s patients. The anesthesiologists would work for the anesthesia company, the referring physicians would bill for their services and pay the anesthesiologists a negotiated rate, and the referring physicians would retain the balance of the professional fees paid for anesthesia services. The OIG first determined that separating the federal health care program patients from payment of the fee did not avoid implicating the antikickback statute, because there was a risk that the anesthesiologists would be paying the management services fees for non–federal health care program patients to induce the referring physicians to refer of all of their patients, including federal health care program patients. It is significant that the ASCs owned by the referring physicians planned to continue to charge a facility fee, which pays for some of the same services that the management services fee was to cover. The OIG expressed concern about the company model arrangement, noting that it “appears that [the arrangement] is designed to permit the Centers’ physician-owners [the referring physicians] to do indirectly what they cannot do directly; that is, to receive compensation, in the form of a portion of the Requestor’s [the anesthesiologists’] anesthesia services revenues, in return for their referrals to the Requestor.”16 Even if the payments to the anesthesiologists could be protected under a so-called safe harbor, a business arrangement that meets regulatory requirements and is not subject to prosecution (discussed later), the retained profit was not subject to such protection. The legality of an arrangement depends on the intent of the parties, so the absence of safe harbor protection does not mean that the arrangement is illegal. The OIG was concerned that the anesthesia company was set up just to provide services to the referring physicians’ own patients, and that the referring physicians would not actually participate in the operation of the anesthesia company, which reflected long-standing concerns of the OIG with “suspect contractual joint ventures.” Advisory opinions apply only to the specific facts outlined in the request for the advisory opinion. Nonetheless, they are viewed as helpful guidance to the industry. The referring physician community is trying to restructure arrangements to conform to the OIG guidance, and the anesthesia community is continuing to seek guidance from federal and state agencies on the legality of these arrangements. Anesthesiologists need to consider whether state law may render arrangements such as the 2 outlined in the OIG advisory opinion and variations on those arrangements unlawful. In particular, state laws barring kickbacks and physician selfreferrals and state laws prohibiting fee-splitting may make such arrangements unlawful. Stark and physician self-referrals
The federal law that limits physician self-referrals, known as Stark II,17 is a civil federal statute, in contrast with the antikickback statute, which is a criminal law. Stark II prohibits physicians from making referrals for designated health services (DHS) to an entity in which they or their immediate family members have a financial interest, either by way of ownership or compensation, unless an exception applies. The law prohibits the entity from billing Medicare, the patient, or a third party payor for the services or goods provided as a result of such a referral. The term DHS includes the following services: (1) clinical laboratory services; (2) physical therapy, occupational therapy, and speech-language pathology
545
546
Semo
services; (3) radiology services, including magnetic resonance imaging, computed axial tomography scans, and ultrasound services; (4) radiation therapy services and supplies; (5) durable medical equipment and supplies; (6) parenteral and enteral nutrients, equipment, and supplies; (7) prosthetics, orthotics, and prosthetic devices and supplies; (8) home health services; (9) outpatient prescription drugs; and (10) inpatient and outpatient hospital services.18 Neither ASC services nor anesthesia services are DHS, so anesthesiologists performing surgical anesthesia services in an ASC or office typically do not refer for DHS. (In contrast, in a hospital setting, anesthesiologists may refer for inpatient or outpatient hospital services in connection with ordering testing of patients.) Pain physicians may refer for certain categories of DHS and may need to consider how Stark affects their practice.19 There is further discussion of how Stark applies to ambulatory anesthesia practice and the exceptions of interest to anesthesiologists in the American Society of Anesthesiologists publication, Ambulatory Surgical Centers: A Manual for Anesthesiologists (chapter VII). Contracts
Contracts and contract interpretation are part of the business of ambulatory anesthesia practice, because anesthesiologists often enter into professional services agreements with ASCs and physician offices. The contracts typically reflect the business terms agreed to by the parties. There is a detailed discussion of contract issues that arise in ASC agreements in the American Society of Anesthesiologists publication, Ambulatory Surgical Centers: A Manual for Anesthesiologists (chapter III). If the ASC or office owners ask the anesthesiologists to provide items or services of value, or require the anesthesiologists to allow the referring physicians or a company they own to bill for the anesthesia services (with the anesthesiologists receiving less than their full professional fees), in exchange for the right to provide services at the ASC or office, the anesthesiologists should consult counsel regarding the legality of the arrangement (discussed earlier). OWNERSHIP-RELATED LEGAL ISSUES
The other category of legal issues relates to who may own an ASC and the regulatory requirements relating to such ownership. Ownership of an office is not regulated for purposes of Medicare and federal health care programs, in large part because Medicare does not pay a facility fee for procedures performed in offices. Federal Antikickback Statute Restrictions on Ownership
The concern with investment interests in ASCs is that the ownership interests might be given to physicians as an inducement for them to refer business to the investment ASC. As noted earlier, the antikickback statute is broad in its prohibition. It prohibits offering or paying, or soliciting or receiving any remuneration that is intended to induce referrals of items or services payable under federal health care programs. That prohibition is broad, so Congress directed the OIG to issue so-called safe harbors; practices that, although potentially capable of inducing referrals of business under federal and state health care programs, are not treated as criminal offenses under the antikickback statute. Because the antikickback statute is intent based, the failure to fit within a safe harbor does not mean that the arrangement is illegal. It does mean that it is necessary to review the transaction to assess whether it violates the antikickback statute.
Legal Aspects of Ambulatory Anesthesia
Given the high degree of interest in physician ownership of ASCs, the OIG promulgated a safe harbor relating to investment interests in ASCs.20 The purpose of the ASC safe harbor is to protect investment interests held by physicians who use the ASC as an extension of their practices. It is focused on surgeons and other physicians who agree to perform no less than one-third of their outpatient procedures at the investment ASC. The safe harbor does not extend to ownership by primary care physicians, because of the concern that ASC ownership by such physicians may be a way to reward them for referrals to surgeons and other investors. In issuing the safe harbor, the OIG stated that it would look for indicia that the ASC investment represents the extension of a physician’s office space, and not a means to profit from referrals.21 Some of the requirements listed later (in particular the requirements related to [1] performance of one-third of the procedures at the investment ASC, and [2] deriving at least one-third of each physician investor’s medical practice income from all sources for the prior fiscal year or prior 12-month period from performance of Medicare-covered procedures [the so-called one-third/one-third test]) are designed to ensure that the investment ASC is an extension of the investing physician’s practice. The safe harbor for ASC investments covers 4 types of ASCs: (1) surgeon-owned ASCs, (2) single-specialty ASCs, (3) multispecialty ASCs, and (4) hospital/physician ASCs. There are detailed requirements pertaining to each type of ASC.22 Investments in multispecialty ASCs are typically the type in which anesthesiologists wish to invest. The requirements for the safe harbor applicable to multispecialty ASCs include the one-third/one-third test noted earlier. (The safe harbors for the 3 other types of ASCs similarly require that all eligible investors derive at least one-third of their individual medical practice incomes from all sources for the prior fiscal year or prior 12-month period from performance of Medicare-covered procedures.) Because anesthesia services are not on the list of procedures,23 anesthesiologists do not meet the requirements of the safe harbor for ASC investments. In contrast, pain medicine physicians may be able to satisfy the one-third/one-third test. As noted earlier, it is not necessary for a transaction to satisfy a safe harbor to be legal. The question is the intent of the parties. Because anesthesiologists do not refer procedures to the investment ASC, an ownership interest is unlikely to be intended as an inducement for the anesthesiologists to refer items or services to the investment ASC. (Pain medicine physicians are in a position to refer cases to an investment ASC, so their situation needs to be assessed separately. As noted earlier, pain medicine physicians may be able to satisfy the one-third/one-third test.) Moreover, to the extent that the one-third/one-third test is intended to ensure that the investment ASC is an extension of the investing physician’s practice, that goal is met in the case of anesthesiologists. Their practice at ASC is an extension of their practice. Anesthesiologists often are given opportunities to invest in ASCs to reward them for their efforts in working hard to make the ASC successful, not for any illegal purpose. In summary, it is not illegal for anesthesiologists to invest in ASCs, but they typically do not satisfy the requirements of the safe harbor for ASC investments. Stark Law Considerations
The Stark law is unlikely to be implicated in connection with an anesthesiologist’s ownership of an ASC. It would be necessary to consider the Stark law issues if the anesthesiologist were to refer to the investment ASC for DHS. In such an unlikely event, it would be necessary to consider what exceptions might apply to cover the ownership interest. Stark law analysis is complex, so anesthesiologists who are
547
548
Semo
concerned with potential Stark issues in connection with ASC practice should consult experienced health law counsel. State Law Requirements
State law may apply to an anesthesiologist’s ownership interest in an ASC. States have passed many types of laws relating to ASC ownership, including the following: Requirements that referring physicians perform the services themselves
Some state laws require physicians investing in health care facilities to perform clinical services at those facilities in order to refer patients to those facilities. Such laws essentially bar self-referrals, although the term “referral” generally does not include a service provided by the referring physician or a member of the referring physician’s group practice. North Carolina is an example of a state with such a self-referral statute.24 Disclosure or sunshine requirements
Some states do not prohibit investments in ASCs. Instead, they require disclosure to the patient of the referring physician’s ownership interest. For example, in Washington State, if a physician owns an interest in an ASC, the physician must provide the following disclosure before referring a patient to that ASC25: 1. Disclose to the patient in writing that the physician has a financial interest in the ASC 2. Provide the patient with a list of effective alternative facilities 3. Inform patients that they have the option to use one of the alternative facilities 4. Assure patients that they will not be treated differently by the referring physician if the patient chooses one of the alternative facilities Anesthesiologists considering an ASC investment should understand the extent to which state law may regulate their practices, based on such ownership interest. Additional information regarding state law governing ASC investments is available in the American Society of Anesthesiologists publication, Ambulatory Surgical Centers: A Manual for Anesthesiologists (chapter VIII). Given the changing nature of state law, anesthesiologists should check for any updates to the laws in the state(s) in which they practice. SUMMARY
This article is intended to sensitize anesthesiologists to some of the legal issues they may encounter in connection with ASC or office-based practice. Given the complexity of legal issues relating to ambulatory anesthesia, anesthesiologists are advised to consult counsel at an early stage so as to understand the issues that may apply to their practices. REFERENCES
1. State operations manual, appendix L, guidance for surveyors: ambulatory surgical centers, section Q-0061, at page 59. Available at: http://www.cms.gov/Regulationsand-Guidance/Guidance/Manuals/downloads/som107ap_l_ambulatory.pdf. Accessed September 2, 2013. 2. ALA. ADMIN. CODE r. 540-X-10-.01(2)(b) (2013). 3. State operations manual, appendix L, guidance for surveyors: ambulatory surgical centers, section Q-0229, at page 133. 4. State operations manual, appendix L, guidance for surveyors: ambulatory surgical centers, section Q-0229, at page 134.
Legal Aspects of Ambulatory Anesthesia
5. 6. 7. 8. 9. 10.
11. 12.
13.
14. 15. 16.
17. 18. 19.
20. 21. 22.
23. 24. 25.
ARIZ. ADMIN. CODE x R4-16-702.A.5. 42 C.F.R. x 416.42(a)(1). 42 C.F.R. x 416.42(a)(2). 42 C.F.R. x 416.42(b)(1) and (2). 42 C.F.R. x 416.42(b)(2). State operations manual, appendix L, guidance for surveyors: ambulatory surgical centers, section Q-0062, at pages 60–1. Available at: http://www.cms.gov/ Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_l_ambulatory. pdf. Accessed September 2, 2013. Id. at section Q-0063, at pages 62–4. A detailed listing of state law requirements regarding administration of anesthesia in ASCs as of 2007 is available in Ambulatory Surgical Centers: A Manual for Anesthesiologists, published by the American Society of Anesthesiologists, at pages 49–55. Available at: http://www.fsmb.org/pdf/grpol_regulation_office_based_surgery.pdf and http://www.fsmb.org/pdf/GRPOL_Office_Based_Surgery_N-Z.pdf. Accessed March 20, 2014. 42 U.S.C. x 1320a-7b(b). United States v. Kats, 871 F.2d 105 (9th Cir. 1989); United States v. Greber, 760 F.2d 68 (3d Cir.), cert. denied, 474 U.S. 988 (1985). OIG, advisory opinion 12-06 (2012), at page 10. Available at: http://oig.hhs.gov/ fraud/docs/advisoryopinions/2012/AdvOpn12-06.pdf. Accessed September 2, 2013. 42 U.S.C. x 1395nn (section 1877 of the Social Security Act). 42 U.S.C. x 1395nn (h)(6); 42 C.F.R. x 411.351. Further discussion of the Stark law appears in Ambulatory Surgical Centers: A Manual for Anesthesiologists, published by the American Society of Anesthesiologists, Chapter VII, at pages 91–115. 64 Fed. Reg. 63, 517 (1999). The ASC safe harbor appears in 42 C.F.R. x 1001.952(r). 64 Fed. Reg. at 63,535–36. Further detail on the specifics of the requirements appears in Ambulatory Surgical Centers: A Manual for Anesthesiologists, published by the American Society of Anesthesiologists, Chapter VI, pages 67–75. The term “procedures” means any procedure(s) on the list of Medicare-covered procedures for ASCs. See 42 C.F.R. x 1001.952(r)(5). N.C. GEN. STAT. x; 90–406. WASH. REV. CODE x 19.68.010(2).
549
