Cleveland Clinic Health System Obligated Group - FMSbonds.com

Cleveland Clinic Health System Obligated Group - FMSbonds.com Cleveland Clinic Health System Obligated Group - FMSbonds.com

09.07.2015 Views

provide “appropriate medical screening” to patients who come to the emergency department. If an emergencymedical condition exists, the hospital must stabilize the patient or effect an appropriate transfer of the patient. OnSeptember 9, 2003, CMS issued rules clarifying hospital obligations under EMTALA. The rules expanded thedefinition of hospital emergency department to include any department or facility of the hospital, regardless ofwhether it is located on or off the main hospital campus, that (i) is licensed by the state in which it is located underapplicable state law as an emergency room or emergency department; (ii) is held out to the public as a place thatprovides care on an emergency medical or urgent care basis or (iii) provides at least one third of all of its outpatientvisits for the examination and treatment of emergency medical conditions. The rules also clarify the physician “oncall”requirements to allow hospitals the discretion to develop their on-call lists in a way that best meets the needs oftheir communities. Furthermore, the rules permit hospital departments that are off-campus to provide the mosteffective way for caring for emergency patients without requiring that the patient be moved to the main campus. Inaddition, the rules provide that emergency room services provided to screen and stabilize a Medicare beneficiaryfurnished after January 1, 2004, must be evaluated for Medicare’s “reasonable and necessary” requirements on thebasis of information available to the treating physician or practitioner at the time the services were ordered. OnAugust 1, 2006, CMS released a rule finalizing two further revisions to the EMTALA regulations, one relating tolabor and delivery related discharges and the other requiring that all Medicare-participating hospitals withspecialized capabilities, including specialty hospitals, must accept appropriate transfers of unstable individuals,regardless of whether the hospital with specialized capabilities has an emergency department.In the IPPS 2009 Final Rule, CMS made further amendments to EMTALA. Under the IPPS Final Rule, ifan individual with an unstable emergency medical condition presents to a participating hospital and is admitted, theadmitting hospital has satisfied its EMTALA obligation. If the patient is subsequently transferred to a hospital withcapabilities for specialized care, that hospital does not have an EMTALA obligation to accept the individual. CMSinvites ongoing public comment on whether this policy results in unintended consequences, such as refusals byhospitals with specialized capabilities to accept the transfer of inpatients whose emergency medical conditionremains unstabilized. The IPPS Final Rule also finalizes requirements that hospitals must meet to participate in acommunity call plan to share on-call responsibilities and comply with EMTALA.Failure to comply with the EMTALA may result in a hospital’s exclusion from the Medicare and/orMedicaid programs, as well as civil monetary penalties. As such, failure of the Obligated Issuers to meet theirresponsibilities under the EMTALA could adversely affect the financial condition of the Obligated Issuers.Management of the Cleveland Clinic believes its policies and procedures are in material compliance withEMTALA, but no assurance can be given that a violation of EMTALA will not be found. Any sanctions imposed asa result of an EMTALA violation could have a material adverse effect on the future operations or financial conditionof the Obligated Issuers.Enforcement ActivityEnforcement activity against health care providers has increased, and enforcement authorities mayaggressively pursue perceived violations of health care laws. In the current regulatory climate, it is anticipated thatmany hospitals and physician groups may be subject to an audit, investigation, or other enforcement actionregarding the health care fraud laws mentioned above. The cost of defending such an action, the time andmanagement attention consumed, and the facts of a case may dictate settlement. Therefore, regardless of the meritsof a particular case, a hospital could experience materially adverse settlement costs, as well as materially adversecosts associated with implementation of any settlement agreement. Prolonged and publicized investigations couldalso be damaging to the reputation and business of a hospital, regardless of outcome.Certain acts or transactions may result in violation or alleged violation of a number of the federal healthcare fraud laws described above, and therefore penalties or settlement amounts often are compounded. Generallythese risks are not covered by insurance.Joint VenturesThe OIG has expressed its concern in various advisory bulletins that many types of joint venturearrangements involving hospitals may implicate the Anti-Kickback Statute, since the parties to joint ventures are36

typically in a position to refer patients of federal health care programs. In its 1989 Special Fraud Alert, the OIGraised concern about certain physician joint ventures where the intent is not to raise investment capital to start abusiness but rather to “lock up a stream of referrals from the physician investors and compensate these investorsindirectly for these referrals.” The OIG listed various features of suspect joint ventures, but noted that its list wasnot exhaustive. These features include: (i) whether investors are chosen because they are in a position to makereferrals; (ii) whether physicians with more potential referrals are given larger investment interests; (iii) whetherreferrals are tracked and referral sources shared with investing physicians; (iv) whether the overall structure is a“shell” (i.e., one of the parties is an ongoing entity already engaged in a particular line of business); and (v) whetherinvestors are required to invest a disproportionately small amount or are paid extraordinary returns in comparisonwith their risk.In April 2003, the OIG issued a Special Advisory Bulletin indicating that “contractual joint ventures”(where a provider expands into a new line of business by contracting with an entity that already provides the itemsor services) may violate the Anti-Kickback Statute and expressing skepticism that existing statutory or regulatorysafe-harbors would protect suspect contractual joint ventures. In January, 2005, the OIG published its SupplementalProgram Guidance for hospitals and reiterated its concerns regarding joint ventures entered into by hospitals.In addition, under the federal tax laws governing Section 501(c)(3) organizations, a tax-exempt hospital’sparticipation in a joint venture with for-profit entities must further the hospital’s exempt purposes and the jointventure arrangement must permit the hospital to act exclusively in the furtherance of its exempt purposes, with onlyincidental benefit to any for-profit partners. If the joint venture does not satisfy these criteria, the hospital’s taxexemptionmay be revoked, the hospital’s income from the joint venture may be subject to tax, or the parties may besubject to some other sanction. See “Tax-Exempt Status of the Obligated Issuers and the Series 2008 Bonds” forfurther discussion of risks related to the tax-exempt status of the Cleveland Clinic and certain of the ObligatedIssuers.Finally, many hospital joint ventures with physicians may also implicate the federal Stark Law.Any evaluation of compliance with the Anti-Kickback Statute or tax laws governing Section 501(c)(3)organizations depends on the totality of the facts and circumstances. While management of the Combined Groupbelieves that the joint venture arrangements to which the Combined Group is a party are in material compliance withthe Anti-Kickback Statute and OIG policies, and the tax laws governing Section 501(c)(3) organizations, there canbe no assurance that the IRS or OIG will not take a contrary view. Any determination that it is not in compliancewith the Anti-Kickback Statute and OIG policies could have a material adverse effect on the future operational orfinancial condition of the Obligated Issuers.The Obligated Issuers have entered or are in the process of entering into several joint ventures withphysicians. The ownership and operation of certain of these joint ventures may not meet safe harbors under theAnti-Kickback Statute. Management of the Obligated Issuers has proceeded or is proceeding with the transactionsrelated to the joint ventures on the assumption, after consultation with its legal counsel, that each of the transactionsrelated to the joint ventures is in material compliance with the Stark Law and the tax laws governing Section501(c)(3) organizations, and is otherwise generally in material compliance with the Anti-Kickback Statute.However, there can be no assurance that regulatory authorities will not take a contrary position or that suchtransactions will not be found to have violated the Stark Law, the tax laws governing Section 501(c)(3)organizations and/or the Anti-Kickback Statute. Any such determination could have a material adverse effect on thefuture operations or financial condition of the Obligated Issuers.HIPAA Administrative SimplificationProviders of health care and operators of health plans are significantly affected by certain healthinformation requirements contained in the “administrative simplification” provisions of HIPAA, which requirestandardization of electronic transactions, specific security protections for medical information and processes,privacy protections for patient health information, and establishment of national employer and provider identifiers.DHHS and CMS have promulgated rules related to electronic transactions, national employer identifiers, nationalprovider identifiers, security, and privacy. Rules regarding national health plan identifiers, claims attachmentsstandards and first report of injury standards have been published in proposed form or are under development.37

typically in a position to refer patients of federal health care programs. In its 1989 Special Fraud Alert, the OIGraised concern about certain physician joint ventures where the intent is not to raise investment capital to start abusiness but rather to “lock up a stream of referrals from the physician investors and <strong>com</strong>pensate these investorsindirectly for these referrals.” The OIG listed various features of suspect joint ventures, but noted that its list wasnot exhaustive. These features include: (i) whether investors are chosen because they are in a position to makereferrals; (ii) whether physicians with more potential referrals are given larger investment interests; (iii) whetherreferrals are tracked and referral sources shared with investing physicians; (iv) whether the overall structure is a“shell” (i.e., one of the parties is an ongoing entity already engaged in a particular line of business); and (v) whetherinvestors are required to invest a disproportionately small amount or are paid extraordinary returns in <strong>com</strong>parisonwith their risk.In April 2003, the OIG issued a Special Advisory Bulletin indicating that “contractual joint ventures”(where a provider expands into a new line of business by contracting with an entity that already provides the itemsor services) may violate the Anti-Kickback Statute and expressing skepticism that existing statutory or regulatorysafe-harbors would protect suspect contractual joint ventures. In January, 2005, the OIG published its SupplementalProgram Guidance for hospitals and reiterated its concerns regarding joint ventures entered into by hospitals.In addition, under the federal tax laws governing Section 501(c)(3) organizations, a tax-exempt hospital’sparticipation in a joint venture with for-profit entities must further the hospital’s exempt purposes and the jointventure arrangement must permit the hospital to act exclusively in the furtherance of its exempt purposes, with onlyincidental benefit to any for-profit partners. If the joint venture does not satisfy these criteria, the hospital’s taxexemptionmay be revoked, the hospital’s in<strong>com</strong>e from the joint venture may be subject to tax, or the parties may besubject to some other sanction. See “Tax-Exempt Status of the <strong>Obligated</strong> Issuers and the Series 2008 Bonds” forfurther discussion of risks related to the tax-exempt status of the <strong>Cleveland</strong> <strong>Clinic</strong> and certain of the <strong>Obligated</strong>Issuers.Finally, many hospital joint ventures with physicians may also implicate the federal Stark Law.Any evaluation of <strong>com</strong>pliance with the Anti-Kickback Statute or tax laws governing Section 501(c)(3)organizations depends on the totality of the facts and circumstances. While management of the Combined <strong>Group</strong>believes that the joint venture arrangements to which the Combined <strong>Group</strong> is a party are in material <strong>com</strong>pliance withthe Anti-Kickback Statute and OIG policies, and the tax laws governing Section 501(c)(3) organizations, there canbe no assurance that the IRS or OIG will not take a contrary view. Any determination that it is not in <strong>com</strong>pliancewith the Anti-Kickback Statute and OIG policies could have a material adverse effect on the future operational orfinancial condition of the <strong>Obligated</strong> Issuers.The <strong>Obligated</strong> Issuers have entered or are in the process of entering into several joint ventures withphysicians. The ownership and operation of certain of these joint ventures may not meet safe harbors under theAnti-Kickback Statute. Management of the <strong>Obligated</strong> Issuers has proceeded or is proceeding with the transactionsrelated to the joint ventures on the assumption, after consultation with its legal counsel, that each of the transactionsrelated to the joint ventures is in material <strong>com</strong>pliance with the Stark Law and the tax laws governing Section501(c)(3) organizations, and is otherwise generally in material <strong>com</strong>pliance with the Anti-Kickback Statute.However, there can be no assurance that regulatory authorities will not take a contrary position or that suchtransactions will not be found to have violated the Stark Law, the tax laws governing Section 501(c)(3)organizations and/or the Anti-Kickback Statute. Any such determination could have a material adverse effect on thefuture operations or financial condition of the <strong>Obligated</strong> Issuers.HIPAA Administrative SimplificationProviders of health care and operators of health plans are significantly affected by certain healthinformation requirements contained in the “administrative simplification” provisions of HIPAA, which requirestandardization of electronic transactions, specific security protections for medical information and processes,privacy protections for patient health information, and establishment of national employer and provider identifiers.DHHS and CMS have promulgated rules related to electronic transactions, national employer identifiers, nationalprovider identifiers, security, and privacy. Rules regarding national health plan identifiers, claims attachmentsstandards and first report of injury standards have been published in proposed form or are under development.37

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