Will Medicare Pay Your Facility? The Provider-Based Rules and Why They Are Important To You Thomas W. Coons Ober|Kaler Baltimore, Maryland I. Background. On April 7, 2000, the Centers for Medicare and Medicaid Services (CMS) (then named HCFA) issued requirements for provider-based departments and entities as part of the final rule implementing the prospective payment system for outpatient hospital services. 65 Fed. Reg. 18,433 (Apr. 7, 2000) (codified at 42 C.F.R. § 413.65). The regulation was later amended at 65 Fed. Reg. 47,670, 47,677 (Aug. 3, 2000); 66 Fed. Reg. 59,856, 59,911-14 (Nov. 30, 2001), implementing § 404 of the Benefits Improvement and Protection Act of 2000 (Dec. 21, 2000) (BIPA); and 67 Fed. Reg. 49,982, 50,078-96 (Aug. 1, 2002). CMS provided more explanation of its policies in Program Memorandum A-03-030 (Apr. 18, 2003), together with a sample attestation form. II. Why Is Provider-Based Status Important? Provider-based status has significance for payment, coverage, and compliance. A. Payment Ramifications. From the payment perspective, provider-based means that the entity is considered part of the hospital and that services furnished in that entity may be billed as “hospital services.” Historically this meant that the provider-based unit could appear on the hospital’s cost report and receive an allocation of the hospital’s overhead costs. Given that most providerbased entities, such as hospital outpatient and distinct part units, were reimbursed under a cost-based system, this allocation was important. As more and more entities moved away from cost-based payments, however, this allocation consideration was of dwindling significance. Nevertheless, provider-based status continues to have a significant payment impact. Medicare will pay hospitals for services under OPPS or IPPS only if the hospital furnishes the services directly or under arrangements. This means that the hospital is generally paid a “technical” component or facility fee in addition to the physician’s professional fee (which fee is reduced due to the higher site-of-service reduction). Nonhospital services, such as clinic services furnished in a non-provider outpatient setting, by comparison, are generally reimbursed only under the physician fee schedule (employing the site-of-service practice expense). The hospital facility fee under OPPS (the APC payment) combined with the physician fee schedule payment is typically more than what would be paid were the services furnished in the clinic setting and reimbursed only under the physician fee schedule. B. Coverage Ramifications. From the coverage perspective, certain services must be furnished in a particular setting in order to be covered. For example, partial hospitalization services must be furnished in a certified Community Mental Health Center (CMHC) or a hospital in order to be covered. More significantly, CMS reimburses hospitals for outpatient therapeutic services 2 only if those services are furnished in the hospital or a department of a hospital that has provider-based status in relation to the hospital. 42 C.F.R. § 413.27(a)(1)(iii). Thus, therapeutic services – as opposed to diagnostic services – may not be furnished under arrangements in a nonhospital setting and billed by the hospital as outpatient hospital services. C. Compliance Considerations. There have been cases in which providers’ alleged failures to satisfy provider-based criteria have given rise to False Claims Act charges. III. How Is Provider-Based Status Different From “Under Arrangements” Contracts? A. As noted above, a location that is provider-based is considered to be part of the hospital, and the services furnished in that location are considered to be hospital services. “Under arrangements,” by comparison, is a payment concept that allows the hospital to obtain services for hospital patients from a third-party and then assume financial responsibility for those services. In those instances, the third-party entity bills the hospital. The hospital, in turn, bills Medicare, and the hospital pays the contracted entity for the service, often on a per-service basis. B. Unlike the provider-based requirements, the under arrangements requirements do not mandate that the vendor that is furnishing services under arrangements to hospital patients be integrated with the hospital. Instead, what is required is: 3 1. Payment of the hospital must discharge the liability of the beneficiary or any other person to pay for the service. 2. The hospital may not “merely serve as a billing mechanism” for the performing entity but rather “must exercise professional responsibility over the arranged-for-services.” (Medicare General Information, Eligibility and Entitlement Manual, CMS Pub. 10001, Chapter 5, § 10.3). 3. The hospital must supervise the arranged-for services using many of the same quality controls as are applied to services furnished by the hospital’s employees. 4. The hospital must accept the patient for treatment in accordance with its admission policies. 5. The hospital must maintain a complete and timely clinical record on the patient, including diagnoses, medical history, physician’s orders and progress notes relating to all services received. 6. The hospital must maintain communications with the patient’s attending physician concerning the patient’s progress and need for any revised orders. 7. The hospital’s utilization review and quality assurance programs must apply to the service. C. Note that not all services may be furnished “under arrangements.” Blue Cross, in a 1979 Administrative Bulletin, stated that certain “core services” – coronary intensive care, pharmacy drugs central supply items, 4 IV solutions and operating rooms – may not be obtained under arrangements. Moreover, Medicare coverage limitations may restrict where certain services may be delivered, requiring that they be delivered in the hospital. IV. To Whom Do the Provider-Based Rules Apply? A. General Rule. The rules apply to: (i) provider-based entities (such as rural health clinics), which provide services that are different from those of the main provider; (ii) departments1 of a hospital (defined as a facility or organization that provides the same type of services as furnished by the main hospital); (iii) remote locations of a hospital, such as an inpatient facility for specialty services located many miles away from the main provider (Medicare conditions of participation do not apply to remote locations as independent entities); and (iv) satellite facilities as defined elsewhere in the Medicare regulations (4.2 C.F.R. §§ 412.25(h)(i) and 412.25(e)(i)). B. Multi-Campus Hospitals. Multi-campus hospitals must meet the provider-based criteria. Originally, CMS stated that this meant that one campus had to be designated as the “main provider,” with the remaining campuses being remote locations. Recently, however, CMS has suggested that hospitals could have more 1 A department comprises both the physical facility and the personnel and equipment needed to deliver the services. 5 than one main campus. 74 Fed. Reg. 60316, 60585, Col. 3 (Nov. 20, 2009). C. If No Payment Effect. Where provider-based versus freestanding status has no payment ramification and does not affect beneficiary liability, CMS will not apply the provider-based rules and will not make a status determination. CMS has instructed its Regional Offices not to make provider-based determinations for: 1. Ambulatory Surgery Centers (ASCs); 2. Comprehensive Outpatient Rehabilitation Facilities (CORFs); 3. Home Health Agencies (HHAs); 4. Skilled Nursing Facilities (SNFs); 5. Hospices; 6. Inpatient rehabilitation units excluded from acute care IPPS; 7. (a) Independent diagnostic testing facilities (IDTFs) furnishing only services paid under a fee schedule (e.g., screening mammography), (b) Facilities that furnish only clinical diagnostic laboratory tests, and (c) Facilities that furnish only some combination of IDTF and clinical laboratory services; 8. Ambulances; 6 9. Departments of provider that furnish no service of a type for which separate payment would be made by Medicare (e.g., laundry and medical records departments). 42 C.F.R. § 413.65(a). D. End Stage Renal Disease (ESRD) Facilities. ESRD facilities do not have to meet the requirements of 42 C.F.R. § 413.65. They must satisfy, however, the more limited hospital-based provisions of 42 C.F.R. § 413.174(c) if they wish to be paid the hospitalbased rate. E. Exception for FQHCs and “Look Alikes.” A facility does not have to satisfy the provider-based criteria if: (1) (i) on or before April 7, 2000, it received a § 330 Public Health Service Act grant, or is receiving funding from such a grant under a contract with the grant’s recipient and meets the requirements to receive such a grant, or, (ii) based on a recommendation from PHS, was determined by CMS on or before April 7, 2000, to meet the requirement for receiving such a grant; and (2) since April 7, 1995, it furnished only services that were billed as if they had been furnished by a department of the provider. V. Distinction Between On-Campus And Off-Campus Sites CMS has made important distinctions between on-campus and off-campus sites, imposing greater requirements on off-campus sites. As a result, the definition of “campus” has elevated importance. CMS defines “campus,” in part, as “the physical area immediately adjacent to the provider's main buildings, other areas and structures that are not strictly contiguous to the main buildings but are located 7 within 250 yards of the main buildings, and any other areas determined on an individual case basis, by the CMS regional office, to be part of the provider's campus.” 42 C.F.R. § 413.65(a)(2). Through this definition, CMS has provided a fairly clear standard (250 yards from main buildings), but has also stated that this standard is not absolute and that CMS' regional offices will be given the discretion to allow other locations that are beyond 250 yards to qualify as “oncampus.” Hence, it will be most important for providers with locations that do not meet the 250-yard test but that are “close to the line” to seek guidance from their regional offices. VI. Standards Applicable To On-Campus and Off-Campus Locations. The provider-based regulation requires all provider-based entities to satisfy all of the following requirements: A. Licensure. 1. Departments of the provider, remote locations of a hospital, and satellite facilities must be operated under the same license as the main provider, except in areas where the state requires a separate license for the site. If the state does not permit licensure for the particular type of facility together with the main provider, CMS will not require that the licensure standard be met. 2. “Same license” requirement is not applicable to “entities,” such as HHAs, SNFs, and CORFs, which are separately licensed, or to FQHCs and RHCs. 8 3. If a state health facilities’ cost review commission or other agency that has authority to regulate the rates charged by hospitals or other providers in a state “finds that a particular facility or organization is not part of a provider,” CMS will determine that the facility or organization does not have provider-based status. 42 C.F.R. § 413.65(d)(1). This is applicable primarily to Maryland hospitals. B. Clinical Integration. 1. The professional staff of the facility or organization must have staff privileges at the main provider. (One way requirement.) 2. The main provider must maintain the same monitoring and oversight of the facility or organization as it does for any other department of the provider. 3. The medical director of the facility or organization seeking provider-based status must maintain a reporting relationship with the Chief Medical Officer or other similar official of the main provider, and that relationship must have the same frequency, intensity, and level of accountability as exists in the relationship between the medical director of a department of the main provider and the Chief Medical Officer or other similar official of the main provider. The medical director of the facility or organization seeking provider-based status must be under the same type of supervision and accountability as any other director, medical or otherwise, of the main provider. 9 4. Medical staff committees or other professional committees at the main provider must be responsible for medical activities in the facility or organization, including quality assurance, utilization review, and coordination and integration of services (to the extent practicable) between the facility or organization seeking providerbased status and the main provider. 5. Medical records for patients treated in the facility or organization will be integrated into a unified retrieval system (or cross reference) of the main provider. What this means is that those professionals practicing at either the main provider or the providerbased site must be able to “obtain relevant medical information about care in the other setting.” 65 Fed. Reg. 18,515. 6. Inpatient and outpatient services of the facility or organization and the main provider must be integrated, and patients treated at the facility or organization who require further care must have full access to all services of the main provider and be referred where appropriate to the corresponding inpatient or outpatient department or service of the main provider. CMS may look at frequency of referrals. The farther away the provider-based location is from the main campus, the more problematic this may be. C. Financial Integration. 1. The financial operations of the facility or organization must be fully integrated within the financial system of the main provider, as 10 evidenced by shared income and expenses between the main provider and the facility or organization. 2. The costs of the facility or organization must be reported in a cost center(s) of the provider, and the financial status of the facility or organization must be incorporated and readily identified in the main provider’s trial balance. D. Public Awareness. 1. The facility or organization seeking status as a department of a provider, remote location, or satellite facility must be held out to the public and other payers as part of the main provider. 2. The name of the site should include the name of the hospital. How much the names must match is open to question. In the case of Johns Hopkins Hospital, for example, CMS rejected a providerbased entity’s application because it was named “Johns Hopkins at Greenspring” and not “Johns Hopkins Hospital at Greenspring.” The Departmental Appeals Board, however, rejected that position. 3. All information (advertisements, signs, web-sites, patient registration forms, letterhead) should reflect that the site is part of the hospital. If the hospital and health system have different names, the provider-based location should use the hospital name. CMS has said that it is not sufficient for advertisements to show that the site is part of, or affiliated with, the provider’s network or health care system. 11 4. When patients enter the provider-based facility or organization, they must be aware that they are entering the main provider and will be billed accordingly. This does not mean, however, that facility must bill all patients as though the facility were providerbased (although all Medicare patients must be billed by the facility to reflect the provider-based status of the site). VII. Additional Standards Applicable To Off-Campus Locations. Off-campus sites must satisfy all of the requirements applicable to on-campus sites. In addition, off-campus sites must satisfy standards relating to ownership, administration and supervision, and proximity. A. Operation Under Ownership and Control of the Main Provider. 1. The “business enterprise” that constitutes the facility or organization must be 100 percent owned by the provider. 2. The main provider and the facility or organization seeking status as a department of the provider, remote location, or satellite facility must have the same governing body. 3. The facility or organization seeking status as a department, remote location, or satellite must be operated under the same organizational documents as the main provider. For example, the facility or organization seeking provider-based status must be subject to common bylaws and operating decisions of the governing body of the provider where it is based. 12 4. The main provider must have final responsibility for administrative decisions, final approval for contracts with outside parties, final approval for personnel actions, final responsibility for personnel policies (such as fringe benefits/code of conduct), and final approval for medical staff appointments in the facility or organization. 5. Note that CMS has said that “common control of two separate entities by the same parent organization ... [is not] sufficient to meet a requirement for ownership and control by the main provider.” 65 Fed. Reg. 18,514. 6. The ownership requirement applies to the “business enterprise”; physical assets do not have to be owned and may be leased. 65 Fed. Reg. 18,514. B. Administration and Supervision. The reporting relationship between the facility or organization seeking provider-based status and the main provider does not have to be daily, but it must have the same frequency, intensity, and level of accountability that exists in the relationship between the main provider and one of its departments. Specifically: 1. The facility or organization must be under the direct supervision of the main provider. 2. The facility or organization must be operated under the same monitoring and oversight by the provider as any other department 13 of the provider, and it must be operated just as any other department of the provider with regard to supervision and accountability. The facility or organization director or individual responsible for daily operations at the entity must: a. Maintain with a manager at the main provider a reporting relationship that has the same frequency, intensity, and level of accountability that exists in the relationship between the main provider and its departments (organization chart should support this); and b. Be accountable to the governing body of the main provider in the same manner as any department head of the provider is accountable. 3. Administrative functions—billing services, records, human resources, payroll, employee benefits package, salary structure, and purchasing services—of the facility or organization must be integrated with those of the provider where the facility or organization is based. The same employees or group of employees must handle these administrative functions for the facility or organization and the main provider. Alternatively, the administrative functions for both the facility or organization and the entity must be: a. Contracted out under the same contract; or 14 b. Handled under different contracts, with the contracts of the facility or organization being managed by the main provider. Note that while the discussion regarding administrative integration suggests that employees must be W-2 employees, CMS has said that the regulations “do not explicitly prohibit the use of leased employees.” 65 Fed. Reg. 18,511. C. Location in Immediate Vicinity. 1. The facility or organization and the main provider must be located on the same campus. 2. Alternatively, the facility or organization must be located not more than 35 miles from the main campus of the hospital or critical access hospital. Distance is determined using straight-line distance, not road miles. 3. Alternatively, the facility or organization must demonstrate a high level of integration with the main provider by showing that it meets all of the other provider-based criteria and by demonstrating that it serves the same patient population as the main provider. It must do this by submitting records showing that, during the 12month period immediately preceding the first day of the month in which the application for provider-based status is filed with CMS and for each subsequent 12-month period: 15 a. At least 75 percent of the patients served by the facility or organization reside in the same zip code areas as at least 75 percent of the patients served by the main provider; b. At least 75 percent of the patients served by the facility or organization who required the type of care furnished by the main provider received that care from that provider (for example, at least 75 percent of the patients of an RHC seeking provider-based status received inpatient hospital services from the hospital that is the main provider); or c. If the facility or organization is unable to meet the criteria of a or b above because it was not in operation during all of the 12-month period described, the entity must show that the facility or organization is located in a zip code area among those that accounted for at least 75 percent of the patients served by the main provider during all of the 12month period described. 4. A facility or organization is not considered to be in the “immediate vicinity” of the main provider unless the facility or organization and the main provider are located in the same state or, where consistent with the laws of both states, adjacent states. 5. Facilities are deemed to comply with the “immediate vicinity” requirement if the main provider has a disproportionate share adjustment percentage greater than 11.75% or is described in 42 16 C.F.R. § 412.106 (c)(2) (urban hospital with more than 100 beds and more than 30% of inpatient revenue is from state and local government payments for indigent care) and is: (1) a government owned or operated hospital; (2) a public or private nonprofit corporation that is formally granted governmental powers by a unit of state or local government; or (3) a private hospital that has a contract with a state or local government that includes the operation of clinics located off the main campus of the hospital to ensure access in a well-defined service area to health care services for low-income individuals who are not entitled to Medicare or Medicaid. 6. There is a special exception for certain neonatal intensive care units that are located within 100 miles of a rural children’s hospital that serves as the main provider. VIII. Additional Requirements (“Obligations”). A. EMTALA. Hospital outpatient departments (not SNFs or other non-hospital entities) located on the main premises of the hospital, as well as those located off the main hospital campus but that serve as dedicated emergency departments, must comply with the anti-dumping rules. B. Site of Service. Physician services furnished in hospital outpatient departments or hospital-based entities (other than RHCs) must be billed with the correct 17 site-of-service indicator, so that applicable site-of-service reductions to physician and practitioner payment amounts can be applied. CMS expects hospitals to monitor physicians who practice in the hospital, including offsite departments, to ensure proper billing using the correct site-of-service indicator. 65 Fed. Reg. 18,519. On line 24b of the CMS 1500 form, therefore, the physician should record “22” for the hospital outpatient setting or “23” for the hospital emergency room rather than “11” for office setting. C. Provider Agreement. Hospital outpatient departments must comply with all the terms of the hospital’s provider agreement. D. Nondiscrimination. Physicians who work in hospital outpatient departments or hospital-based entities are obligated to comply with the non-discrimination provisions of Title XVIII. E. Billing of Medicare Patients. 1. Hospital outpatient departments must treat all Medicare patients as hospital outpatients for billing purposes. In other words, the hospital must bill a facility charge to Medicare beneficiaries. The department must not treat some Medicare patients as hospital outpatients and others as physician office patients. 2. The uniformity in billing requirement applies only to the billing of Medicare patients. Hospitals may “bill other payers in whatever 18 manner is appropriate under those payers’ rules.” 65 Fed. Reg. 18,519. Thus, the hospital generally must furnish a “split bill” when billing Medicare for Medicare-covered patients (that is, bill the professional component to the Medicare Carrier using the CMS 1500, while billing the facility overhead and technical component to the Medicare Intermediary using the UB-92), but it need not “split bill” private or managed care payers. Often, these payers do not recognize split billing for clinic services, whether or not the clinic is hospital-based, and they will pay a physician fee schedule amount irrespective of the site of service. 3. Complying with the uniformity in billing requirement can get tricky if the outpatient department “shares space” with another entity, such as a non-provider clinic. CMS has suggested that this can be done, but said that the regional offices will have to look at the fact pattern of each case. 65 Fed. Reg. 18,515. The space sharing arrangement, if it is to be approved, presumably will have to delineate the specific times that the space is considered to be “provider-based” and make clear that the space satisfies all provider-based criteria during those times. Sharing of the same space at the same time on an “as-needed” basis will run afoul of these limitations and of other requirements such as those relating to public awareness. See Section XIII C, infra. 19 F. Payment Window. In the case of a patient admitted to the hospital as an inpatient after receiving treatment in the hospital outpatient department or hospital-based entity, payments for services in the hospital outpatient department or hospital-based entity are subject to the payment window provisions applicable to PPS hospitals and to hospitals and units excluded from acute care PPS. G. Informing Beneficiaries (Off-Campus Only). 1. When a Medicare beneficiary is treated in a hospital outpatient department or hospital-based entity that is not located on the main provider’s campus and the beneficiary will incur co-payment liabilities both for the outpatient visit to the hospital and the physician service, the hospital must inform the beneficiary, in writing and prior to the delivery of services, of the beneficiary’s potential financial liability, including coinsurance liability for both the hospital outpatient visit and the physician services. The notice must be one that the patient can read and understand. If the beneficiary is unconscious, under great duress, unable to read, or for any other reason unable to read a written notice and understand and act on his or her rights, the written notice must be provided, prior to the delivery of services, to the beneficiary’s authorized representative. 20 2. CMS has interpreted this to mean that the hospital must inform the beneficiary not just of the fact that there will be a liability, but also the amount of this liability. CMS has recognized, however, that determining the patient's exact liability may be difficult at times, such as when the treating physician is in the process of diagnosing the patient's condition and is unsure of what services might be ordered. Under such circumstances where the exact type or extent of care is unknown, CMS has said that the hospital may inform the beneficiary that there will be a co-insurance liability that he or she would not incur if the facility were not provider-based, and furnish an estimate based on typical or average charges for visits to the facility but at the same time state that the patient’s actual liability will depend upon the services actually furnished. See Section XIII D, infra. 3. In an EMTALA setting, notice of beneficiary liability should be given as soon as possible after the existence of the emergency has been ruled out or the patient has been stabilized. H. Health and Safety. Hospital outpatient departments must meet applicable hospital health and safety rules for Medicare participating hospitals. I. Physician Supervision of “Incident to” Therapeutic Services and Supplies (42 C.F.R. § 410.27). Services and supplies furnished at a location that CMS designates as a hospital department must be under the direct supervision of a physician. 21 “Direct supervision” means that the physician must be present on the premises and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed. How these rules should be applied has been subject to change. Originally, CMS stated that it would assume that direct supervision exists if the outpatient department is located on the hospital campus, but that the assumption would not extend to departments located at off-campus sites. More recently, however, CMS has retreated from that position and has stated that there is a supervision requirement for all outpatient services, not matter where furnished. See Section XIII A, infra. IX. Special Rules For Joint Ventures And Management Contracts. CMS has created special rules for management contracts and joint ventures, which again turn on whether the site is on or off the campus of the main provider. A. Joint Ventures. In order for a facility or organization to operate as a joint venture, it must: (1) be partially owned by at least one provider; (2) be located on the main campus of at least one of the partial owner providers; (3) be providerbased to the main provider on whose campus it is located (even if a minority owner); and (4) meet all other provider-based requirements. Thus, joint ventures are permitted for on-campus locations, and the services they furnish will be billed using the provider number of the main provider. Note that in order for the services furnished by the joint venture 22 to be provider-based, the clinical integration requirement will mandate that the provider have complete control over many elements of the joint venture. Additionally, the public awareness criterion will require signage to designate the site as part of the main provider. See Section XIII E, infra. B. Management Contracts. 1. Management contracts for on-campus sites are permissible. Offcampus locations operated under management contracts, however, are considered provider-based only if they meet all of the following criteria: a. The staff of the facility or organization, other than management staff and staff providing services paid under the physician fee schedule, are employed by the provider (or by another organization, other than the management company, which also employs the staff of the main provider). Other than staff paid under the physician fee schedule, the main provider may not utilize the services of “leased” employees who are directly involved in the furnishing of patient care. b. The administrative functions of the facility or organization are integrated with those of the main provider. c. The main provider has significant control over the operations of the facility or organization. 23 d. The management contract is held by the main provider itself, not by a parent organization that has control over both the main provider and the facility or organization. 2. To conform to these requirements, it is advisable that the management contract state that the provider has ultimate control over the facility or organization; that all decisions and policies of the contractor are subject to hospital review and approval; that all personnel, whether employed by the hospital or by the contractor, be required to comply with the hospital policies and rules; and that the contractor must periodically report in writing to the hospital. In addition, the agreement should plainly delineate who are “management employees,” and these individuals should have job descriptions consistent with that label. 3. Often the management contract provides for the furnishing of services also available through the main provider (e.g., billing services, computer services, accounting services, general administrative staff services). To the extent the main provider can identify such “like” costs, it must carve out those costs to ensure that they are not allocated to the department or provider-based entity. 42 C.F.R. § 413.24(d)(6). If the main provider is unable to identify the “like” costs, the costs of services purchased through the management contract must be reclassified to the main 24 provider’s administrative and general cost center and allocated down to all reimbursable and non-reimbursable cost centers. X. Provider-Based Limitations on Use of Under Arrangements Services. The Medicare statute at 42 U.S.C. § 1395x(w)(1) recognizes that a hospital may bill for services furnished at non-hospital locations if the services are furnished “under arrangements.” See also 42 U.S.C. § 1395x(s)(2)(C). CMS recognized this in the preamble to its 2000 regulation, stating the provider-based rule will not prevent providers from furnishing “selective services” under arrangement. 65 Fed. Reg. 18,518. CMS went on to provide, however, that a facility or organization may not qualify for provider-based status if all services furnished by the facility are furnished under arrangements. CMS has not been clear about whether certain specific services might run afoul of this bar, particularly if the service furnished “under arrangements” may essentially amount to the entire hospital department. For example, if the hospital obtains all of its MRI procedures, hyperbaric oxygen or other specialty services “under arrangements,” is the bar implicated? CMS has not formally answered that question, although it has suggested it might allow those services to be furnished “under arrangements.” XI. Application To Medicaid. In the preamble to the final provider-based regulations, CMS stated that since “hospitals under Medicaid are required to meet the same standards as Medicare facilities, these final rules would affect the Medicaid definition of these facilities as well as the Medicare definitions.” 65 Fed. Reg. 18,506. CMS has said, however, that while facilities or organizations that are not provider-based have to 25 meet the service standards that apply to freestanding entities of their type, States have considerable flexibility to determine appropriate payment rates in their State Medicaid plans. CMS has also said that States may adopt higher payment rates for services at those freestanding entities to reflect special circumstances, which payment rates could include higher cost structures due to affiliation with a provider. Thus, a State could pay a site as provider-based even if Medicare does not. In order to do this, however, the State must provide for such payment in its State plan. See 67 Fed. Reg. 50,083. XII. Approval Process. A. Approval not required. Formal CMS approval is not required for oncampus or off-campus sites as a condition of billing and payment. CMS, however, will consider applications, which it terms “attestations,” and will approve or reject them. Providers should seriously consider seeking approval, the benefit of which is to limit the risk of retrospective recoveries if CMS subsequently determines that the site is not providerbased. If a site does not have approval and has been billing for services as provider-based, CMS will recover the excess payments for the entire period subject to reopening. The risk associated with such a recovery may be minimal for most on-campus sites, but this is not necessarily the case for off-campus sites. CMS has stated that there is a presumption that an off-site clinic is a freestanding location. 42 C.F.R. § 413.65(b)(4). B. The attestation process differs depending on whether the site is on-campus or off-campus. If the site is on-campus, the provider need not submit 26 supporting documentation, but if the site is off-campus, the provider must submit documentation together with the attestation. Even for on-campus locations, however, the submission of supporting documentation may be advisable at times, such as where there is a joint venture. As part of PM A-03-030, CMS issued a sample attestation format that one may employ. C. Attestations may be submitted for the whole site or, if the site houses both provider-based and freestanding locations, for a portion of a site. A single attestation may cover multiple facilities (or cost centers). Documentation, if submitted, and provider statements must be sufficiently specific to address each facility (or cost center). Thus, a “one size fits all” attestation will not easily work, particularly for off-campus sites. D. The attestation is filed with the fiscal intermediary and the regional office. The regional office has the authority to approve or reject the attestation. CMS has said only that it will act “promptly.” There is no deadline for CMS to act on attestations. Delays of a year or more are not uncommon. E. CMS will request additional information if the attestation appears incomplete or if the agency otherwise has questions. F. CMS approval is binding absent “material changes.” CMS has not defined material change but has given the example of entering into a management contract. XIII. Issues For Providers. A. Outpatient services and supervision. 1. General Principles. 27 a. The supervision requirements apply only to hospital outpatient services and not inpatient services, at least for now. Different rules may apply to therapeutic and diagnostic services. b. What are “therapeutic” services? (i) Therapeutic services aid the physician in the treatment of a patient. (ii) Outpatient therapeutic services and supplies include those services and supplies (including the use of hospital facilities) that are “incident” to the services of physicians (and effective January 1, 2010 certain nonphysician practitioners (“NPPs”)) in the treatment of patients. 42 U.S.C. § 1395x(s)(2)(B); 42 C.F.R. § 410.27; Medicare Benefit Policy Manual (MBPM), Chp. 6, § 20.5.1. (iii) Although there is some ambiguity regarding this, CMS’s current view appears to be that “therapeutic” services also includes those that may have a separate benefit category for coverage, such as radiation therapy. (iv) Hospital outpatient therapeutic services must be performed in the hospital or in hospital provider- 28 based departments to be covered for Medicare payment purposes. 42 C.F.R. § 410.27(a)(1)(iii). c. What are outpatient diagnostic services? (i) A hospital outpatient diagnostic service is an examination or procedure to which a patient is subjected, or that is performed on materials derived from a hospital outpatient, in order to obtain information to aid in the assessment of a medical condition or the identification of a disease. 42 U.S.C. § 1395x(s)(2)(C); 42 C.F.R. § 410.28; MBPM, Chp. 6, § 20.4.1. (ii) Hospital outpatient diagnostic services must be furnished within the hospital or in a provider-based department, or provided by another entity in a nonhospital facility and billed by the hospital under arrangements. supervision The services must satisfy the requirements of 42 C.F.R. § 410.32(b)(3), 42 C.F.R. § 410.28(e). d. Hospital outpatient services excluded from the Medicare general outpatient coverage requirements. (i) Hospital outpatient services excluded from the Medicare general outpatient coverage requirements are physical therapy, speech-language pathology, 29 and end stage renal disease services. MBPM, Chp. 6, § 20. 2. Hospital outpatient supervision requirements – pre-2010: a. Hospital outpatient therapeutic services. (i) As noted above, in the 2000 OPPS final rule, HCFA stated that physician direct supervision was required for outpatient therapeutic incident to services furnished in hospital off-campus outpatient departments. 65 Fed. Reg. 18434 (Apr. 7, 2000). HCFA also stated, however, that the physician direct supervision requirement does not apply to therapeutic services furnished in hospital main buildings and on-campus departments and that the agency assumed that the physician direct supervision requirement was met because staff physicians would always be nearby within the hospital. CMS also stated, by contrast, that direct supervision would not be assumed in situations where the services were furnished “incident to” in a department of a hospital located off the campus of the hospital. This position was reinforced by Intermediary Manual § 3112.4(A), 30 (ii) In the preambles to the 2009 OPPS proposed and final rules (73 Fed. Reg. 41416 (July 18, 2008) and 73 Fed. Reg. 68502 (Nov. 18, 2008) respectively), however, CMS included a “restatement and clarification” of the physician direct supervision requirement for outpatient therapeutic services performed in hospital main buildings and oncampus departments. It stated that it was “concerned that some stakeholders may have misunderstood our use of the term ‘assume’ in the April 7, 2000 OPPS final rule” and that “[i]t is our expectation that hospital outpatient therapeutic services are provided under the direct supervision of physicians in the hospital and in all provider-based departments of the hospital, specifically both oncampus hospital.” and off-campus departments of the See also 73 Fed. Reg. at 68702 and 68703. b. Hospital outpatient diagnostic services. (i) In the 2000 OPPS final rule, HCFA described that all hospital outpatient diagnostic services, whether provided in a hospital’s main buildings, on-campus departments or off-campus departments, must be 31 furnished under the appropriate level of physician supervision (general, direct, or personal), as included in the Medicare Physician Fee Schedule Relative Value File (“MPFS RVF”). See 42 C.F.R. § 410.28(e). (ii) For services requiring physician general supervision, the procedure is furnished under a physician’s overall direction and control, but the physician’s presence is not mandated during the performance of a procedure. A physician must be present and immediately available to furnish assistance and direction throughout the performance of a procedure requiring direct supervision. For those services that require physician personal supervision, a physician must be in attendance in the room where the procedure is being performed. See 42 C.F.R. § 410.32(b)(3). 3. Hospital outpatient supervision requirements effective January 1, 2010. a. Outpatient therapeutic services. (i) In the 2010 OPPS final rule, CMS restated the principle that outpatient therapeutic services must be furnished in the hospital to be covered for 32 Medicare payment purposes. “In the hospital” is defined as those areas in the main buildings of the hospital that are under the ownership, financial, and administrative control of the hospital; that are operated as part of the hospital; and for which the hospital bills the services under the hospital’s CMS Certification Number. 42 C.F.R. § 410.27(a)(1)(iii) and (g). (ii) CMS, however, amended the supervision requirement to provide that physicians, clinical psychologists, and under specified conditions certain NPPs, specifically physician assistants, nurse practitioners, clinical nurse specialists, certified nurse-midwives and licensed clinical social workers (hereinafter referred to as “supervisory practitioner”) may supervise outpatient therapeutic services. The exceptions to this general rule are cardiac rehabilitation services, intensive cardiac rehabilitation services, and pulmonary rehabilitation services, all of which require physician supervision, regardless whether performed in a hospital's main buildings, on-campus provider-based department, or off-campus provider-based department. 33 (iii) Under the amended rule, a supervisory practitioner may only supervise those therapeutic services that he/she can properly perform himself/herself under State law, that are within his/her scope of knowledge, practice, and skills, and that are within his/her hospital-granted privileges. Additionally, the supervisory practitioner must be immediately available to furnish assistance and direction throughout the performance of the procedure. The supervisory practitioner (1) may not be performing another procedure or service that he or she could not interrupt to supervise the outpatient therapeutic incident to service and (ii) may not be so far away physically from where the outpatient therapeutic service is being performed that he or she could not intervene right away. (iv) CMS also changed the direct supervision requirement for outpatient therapeutic services performed in a hospital's main buildings and oncampus provider-based departments to allow the supervisory practitioner to be on the same hospital “campus” during the performance of the procedure. Thus, the supervisory practitioner may be in the 34 hospital’s main buildings, in any on-campus provider-based department, or even in on-campus non-hospital space (e.g., a physician’s office, skilled nursing facility, or rural health clinic) while the therapeutic “incident to” service is being performed, as long as the supervisory practitioner is also immediately available. 42 C.F.R. § 410.27(a)(1)(iv)(A). (v) Different rules apply, however, for outpatient therapeutic services provided in a hospital’s offcampus provider-based department. For those offcampus locations, as before, the supervisory practitioner must be present in that provider-based department during the performance of the procedure and immediately available to furnish assistance and direction. 42 C.F.R. § 410.27(a)(1)(iv)(B). b. Hospital outpatient diagnostic tests. (i) In the 2010 OPPS final rule, CMS provided that the supervision requirements for hospital outpatient diagnostic services apply to all outpatient diagnostic tests provided directly by the hospital or by another entity under arrangements, whether furnished in a hospital’s main buildings, on-campus providerbased departments, 35 off-campus provider-based departments, or in non-hospital facilities under arrangements. 42 C.F.R. § 410.28(e). (ii) The level of physician supervision (general, direct, or personal) for specific diagnostic tests wherever performed (in the hospital, in an on-campus provider-based department, in an off-campus provider-based department, or in a nonhospital location under arrangement), as in the past, turns on the supervision levels listed in the Medicare Physician Fee Schedule. (iii) Unlike outpatient therapeutic “incident to” services, physicians must supervise outpatient diagnostic tests. NPPs may not properly supervise these services. (iv) For outpatient diagnostic services that require direct supervision and are furnished directly or under arrangements in the hospital or in an on-campus provider-based department, the supervising physician must be present on the same campus and immediately available to furnish assistance and direction throughout the performance of the procedure. “In the hospital” means those areas in the main buildings of the hospital that are under the 36 ownership, financial, and administrative control of the hospital; that are operated as part of the hospital; and for which the hospital bills the services under the hospital’s CMS Certification Number. (v) For outpatient diagnostic tests that require direct supervision and are provided directly or under arrangements in an off-campus provider-based department, the physician must be present in that off-campus provider-based department and immediately available to furnish assistance and direction throughout the performance of the procedure. (vi) Note that these supervision requirements apply as well to diagnostic tests furnished arrangements in non-hospital locations.” “under For outpatient diagnostic services that require physician direct supervision and are provided under arrangements in physicians' offices and other nonhospital locations, the supervisory physician must be present in the performing physician group's office suite or other nonhospital location and he/she also must be immediately available during the performance of the diagnostic test. 37 3. Supervision Gray Areas. a. Services with other benefit categories. (i) CMS did not expressly state in the 2010 OPPS final rule that hospital outpatient therapeutic services that have their own statutory benefit are subject to the Medicare outpatient physician supervision requirements. It did say in the preamble to the rule, however, that “the only statutory basis for payment of hospital outpatient therapeutic services is incident to the services of a physician.” 74 Fed. Reg. 60582; 60583. This suggests that all therapeutic services are subject to the supervision requirements. b. Qualifications of Supervisory Personnel CMS does not define in the regulations the necessary qualifications that the supervisory personnel for outpatient therapeutic and diagnostic services must possess. Rather, in the preamble to the 2010 OPPS final rule, CMS describes the characteristics practitioner/supervisory of the physician as supervisory including the following: (i) “The supervising physician or nonphysician practitioner must be prepared to step in and perform 38 the service, not just to respond to an emergency.” 74 Fed. Reg. at 60584. “This includes the ability to take over performance of a procedure and, as appropriate to both the supervisory physician or nonphysician practitioner and the patient, to change a procedure or the course of treatment being provided to a particular patient.” Id. (ii) CMS notes that “[t]he [supervising] physician does not ‘necessarily need to be of the same specialty as the procedure or service that is being performed.’” Id. But it also states that, “[i]n order to furnish appropriate assistance and direction for any given service or procedure, we continue to believe the supervisory physician or nonphysician practitioner must have, within his or her State scope of practice and hospital-granted privileges, the ability to perform the service or procedure.” Id. It reinforces this by stating: “We believe that it is inappropriate for a supervisory physician or nonphysician practitioner to be responsible for patients, hospital staff, and services that are outside the scope of their knowledge, skills, licensure, or hospital-granted privileges.” Id. “It would be unreasonable to think 39 that a physician or nonphysician practitioner could competently assist and direct a procedure for which they do not have sufficient knowledge and skills to perform or redirect the procedure or service.” Id. The supervisor must be a person who is “clinically appropriate” to supervise the service or procedure. c. What is Immediately Available? CMS has said that “the supervisory physician or nonphysician practitioner could not be immediately available while, for example, performing another procedure or service that he or she could not interrupt.” 74 Fed. Reg. at 60583. “It would also be neither appropriate nor ‘immediate’ for the supervisory physician or nonphysician practitioner to be so physically far away on the main campus from the location where hospital outpatient services are being furnished that he or she could not intervene right away.” Id. B. Management Contracts/Under Arrangement. 1. Management contracts for services furnished in off-campus locations may pose problems. The manager may not employ any personnel who directly deliver patient care. Instead, the manager 40 may employ managers and receptionists, clerks, and other personnel who do not furnish direct patient care. 2. CMS has not formally stated how to treat personnel who have management positions but also furnish patient care. In the absence of further clarification on this issue, the more conservative course is to have the provider employ at off-campus managed sites all personnel who deliver patient care services (not reimbursed under the physician fee schedule) on other than an incidental basis. The regulation is clear that the provider’s leasing the management contractor’s employees will not satisfy this requirement. 3. In some circumstances, the difference between a management contract and a service obtained “under arrangements” is unclear. The ambiguity lies in how one distinguishes between a management contract and an under arrangement service. Despite requests for clarification on this issue, CMS has not yet clearly differentiated between a management contract and under arrangement services. Instead, it has stated its belief that “there is a substantial difference between the use of management contracts to obtain some or all input services needed to operate a health care facility,” including staff and the use of “arrangements by a provider to obtain specialized health care services that it does not itself offer.” CMS has also stated in the regulatory text that a site 41 may not qualify for provider-based status if “all patient services . . . are furnished under arrangements.” 4. Factors that would likely be viewed by CMS as supporting the designation of an agreement as a management contract, include: • The agreement is titled “management contract.” • The agreement requires the vendor to provide management services. • The services are furnished on the provider’s premises or in space leased by the provider. • The certificate of need (CON) for the service, if one is needed, is held by the provider. • The agreement is exclusive to the provider (i.e., the vendor will not make the service available to competing providers). 5. Conversely, factors that appear to favor an agreement being treated as an under arrangements contract, in addition to the absence of the factors set forth previously, would be: • The agreement is provided on a per service basis. • The patient receiving services from the vendor also receives more than incidental services from other hospital departments. 42 C. Shared Space. 1. The same building can have a number of separate suites, and nothing in the regulation or CMS’ published policies prohibits a provider from treating some parts of a building as provider-based and some not. 2. When there are provider-based clinics and non-provider-based clinics in the same building, CMS has not formally said whether the provider-based and non-provider based clinics may share waiting areas and reception space. On a case-by-case basis, such sharing may be allowed. The costs of the shared space need to be separately identified and properly allocated, of course. Also, because this is very fact specific, providers may want to submit an attestation. 3. Space in which patient care services are provided, however, is another matter and will likely be subject to closer scrutiny. If patient-care related space is to be shared, the space and the time blocks for the use of that space need to be clearly delineated, patient records need to be separate, the signage, uniforms and the like need to be clear to satisfy the “holding out” criteria. Patients using the shared space should have direct access to public hallways and, most desirably, to the outside directly from the space. 4. Concurrent sharing of the same space is unlikely to be permitted. But space may be blocked leased. 43 D. Notice of Co-Insurance. A notice of coinsurance must be issued to Medicare beneficiaries who utilize off-campus sites; no notice of coinsurance is required for services furnished on a hospital’s main campus. 1. The notice obligation applies, according to the regulation, only when the patient “will incur a coinsurance liability for an outpatient visit to the hospital as well as for the physician service.” 42 C.F.R. § 413.65(g)(7). Whether a notice of coinsurance is required, therefore, it depends on what CMS means when it states “incur a coinsurance liability for an outpatient visit as well as for the physician service.” 2. It is not always clear how CMS’s phrase – “will incur a coinsurance liability from outpatient visit to the hospital as well as for the physician service” — should be applied to certain facts. One might argue that a notice of coinsurance should be required only when the physician service and the service billed by the hospital are not separable. Under such circumstances, the patient might not reasonably expect to incur a coinsurance liability for both the physician service and the hospital-furnished service. Conversely, if the physician furnished the service in a nonhospital site or other hospital, the patient should reasonably expect to have two coinsurance liabilities, and a notice of coinsurance might not be required. Additionally, if the hospital service is furnished on a 44 day when there is no physician service furnished, one might maintain that a notice of coinsurance should not be required for the hospital service. Thus, for example, if the patient receives IV therapy in a hospital outpatient department over a span of several weeks, and if there are no billable physician services furnished on the same day as the IV therapy treatments, then no notice of coinsurance should be required with respect to those treatments. The notice must be clear and understandable. CMS does not require that the beneficiary sign the notice, but doing so will enable the hospital to show that it furnished the notice. E. Joint Ventures. 1. The original provider-based regulation required that all departments – on-campus or off-campus – be under the ownership and control of the main provider. CMS relaxed that regulation in 2002 to permit on-campus joint ventures to be provider-based. For a joint venture to qualify as a provider-based department, it must: 1) be partially owned (but not necessarily majority-owned) by at least one provider; 2) be located on the campus of the provider with an ownership interest in the joint venture; 3) be providerbased to the provider on whose campus it is located; and 4) “also meet all the requirements applicable to all provider-based facilities or organizations in paragraph (d)…” 42 C.F.R. § 413.65(f). 45 2. If a site is provider-based, Medicare makes payments to the provider. But if a joint venture is operating a department, then the joint venture is incurring at least some of the expenses for the department. The provider must have the ability to transfer some or all of that money to the joint venture. 3. One issue that troubles providers is how to reconcile the joint venture structure and the requirement that departments be financially integrated with the hospital. Some or all of the expenses of the joint venture department will appear initially on the books of the joint venture. CMS personnel have stated informally that a joint venture will meet the financial integration standard as long as the costs of the joint venture are properly reported on the provider’s cost report. 4. Joint ventures, to be provider-based, require that the provider have considerable control and oversight over the joint venture. Moreover, the Medicare COPs require the governing board of a hospital to be “legally responsible” for the entire hospital. 42 C.F.R. § 482.12. The governing body must “ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services.” 42 C.F.R. § 482.12(e). 46 F. Attestation Process. 1. Should one go through the attestation process? In the preamble to the 2002 amendments to the provider-based rule, CMS stated that “providers are not obligated to submit attestations of applications for provider-based status before they begin billing as provider-based, .… 67 Fed. Reg. 49982, 50086, col. 3 (Aug. 2, 2002). 2. Nevertheless, there are times when going through the process is advisable, particularly for joint ventures and for some or all offcampus locations. 3. CMS Regional Offices may request additional documentation, such as floor plans, documents reflecting administrative and clinical integration and reporting relationships (with their frequency), and, in the case of ASCs, prior ownership relationships. 47
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