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10/01/2000 |
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Thomas W. Coons On April 7, 2000, HCFA issued regulations governing facilities’ qualification for provider-based status. 65 Fed. Reg. 18,434. The regulations affect not only hospital outpatient departments, but satellite facilities, inpatient departments and remote locations of hospitals, as well. The regulations were to become effective on October 10, 2000. The HCFA regulations, understandably, have created considerable concern among providers. The regulations are, in certain places, quite unclear, and, in other areas, seem somewhat inflexible. As a consequence, providers, provider associations, and counsel have been very active in pressing HCFA to issue clarifications of its regulations and, in the meantime, to postpone the regulations’ effective date. HCFA has listened to these pleas. In late September, Nancy-Ann Min DeParle wrote several provider associations notifying them of HCFA’s decision to postpone the effective date of the provider-based rules. Thereafter, HCFA issued a Federal Register notice of the delay of the effective date. 65 Fed. Reg. 58,919–20 (October 3, 2000). In both documents, HCFA stated that it was delaying the effective date of the provider-based rules until January 10, 2001, and that the regulations would be effective for cost reporting periods beginning on or after that date. HCFA’s announcement is a substantial concession. It means that a provider whose cost reporting period begins, for example, on October 1 of the calendar year will not be subject to the provider-based rules until October 1, 2001. The delay will enable hospitals both to obtain clarification from HCFA about the application of the provider-based rules and to prepare their operations to comply with those rules. The delay will also enable HCFA and its contractors to phase in the implementation of the provider-based rules instead of having the rules become effective October 10, 2000 and facing a flood of applications. In its notice, HCFA also recognized that many questions exist regarding the regulation’s application. HCFA announced an intention to issue clarifications and to host a town hall meeting to discuss certain aspects of the provider-based regulations. Particularly, HCFA is interested in discussing the ways in which a facility or organization can demonstrate that it serves the same patient population as the main provider and how the April 7 regulations will affect the provision of services in certain hospital departments through management contracts. HCFA has also taken steps to clarify the April 7 regulations. At roughly the same time it issued its Federal Register notice of the delay in effective date, HCFA posted on its web page a number of provider-based questions and answers. The questions and answers did not, by any means, address all of the provider-based issues that have been raised over the last several months. They are, nevertheless, helpful and reflect a willingness on HCFA’s part to provide guidance to the provider community. The questions and answers were only 19 in number, but one can assume that additional questions and answers will be posted over the next several months. Additionally, in an August 3, 2000 interim final rule, HCFA issued important clarifications regarding the beneficiary cost sharing notice and the Emergency Medical Treatment and Active Labor Act (EMTALA) as they relate to off-campus departments. 65 Fed. Reg. 47,670, 47,675 (Aug. 3, 2000), discussed below. In the April 7 initial rule, HCFA stated that when a beneficiary is treated in a hospital outpatient department or a hospital-based entity and when that department or entity is not located on the hospital’s main campus, the hospital must inform the beneficiary, in writing and prior to the delivery of services, of the beneficiary’s potential financial liability. Many hospitals, however, perceived a tension between this requirement and other requirements set out in EMTALA. Specifically, providers have been concerned that it would not be appropriate to delay the screening and stabilization services mandated by EMTALA to deliver a notice to the patient of his or her financial liability. In its August 3, 2000 rule, HCFA agreed and clarified its position to state that, in EMTALA cases, hospitals would not be required to deliver the notices to beneficiaries before screening and stabilization takes place. In the same rule, HCFA further issued much needed clarification on the nature of the required written notice of liability. Many providers had complained that it is often unknown, when the patient enters a facility, the exact type and extent of care that may be needed by that patient. Thus, the hospitals complained, they are unable to issue an accurate written notice that explains the extent of that patient’s coinsurance liability. Again, in the August 3 rule, HCFA clarified its position, stating that a hospital may furnish a written notice to the patient that simply explains that the beneficiary will incur a coinsurance liability to the hospital that he or she would not incur if the facility were not provider-based. HCFA stated as well that the hospital may furnish an estimate of the patient’s liability based on typical or average charges for visits to the facility or organization, while stating that the patient’s actual liability will depend upon the actual services furnished by the hospital. HCFA has stated its intention to develop a separate proposed rule that will further revise and clarify the nature of the notice requirement. Finally, as part of the August 3 rule, HCFA issued clarification of the EMTALA protocols to be utilized for off-campus departments. In the April 7, 2000 regulation, HCFA specified that off-campus facilities might not be routinely staffed by physicians, RNs or LPNs, but would nevertheless be required to comply with EMTALA by contacting emergency personnel at the main hospital campus. Providers pointed out, however, that situations might arise where the main hospital campus does not have the specialized capability or facilities required by the individual or where the individual’s condition is deteriorating so rapidly that the time needed to move the individual to the main hospital campus would jeopardize his or her health or safety. Providers then asked whether they would be required to contact emergency personnel at the main hospital to obtain advice and instruction even before arranging an appropriate transfer to a medical facility other than the main hospital. HCFA clarified that in any case arising in an off-campus department, the contact between the off-campus personnel and the emergency personnel at the main hospital campus should be made either after or concurrently with the actions needed to arrange an appropriate transfer if doing otherwise would significantly jeopardize the individual’s health or safety. The clarifications issued by HCFA to date answer only a small number of the many questions raised by the provider-based rules. HCFA, however, has shown a willingness to address those questions and to provide at least some level of guidance to the provider community. Future clarifying regulations and less formal pronouncements should be expected. Thomas W. Coons is a principal in Ober|Kaler's Health Law Department. He can be reached by email at twcoons@ober.com or 410-347-7389. |
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Ober, Kaler, Grimes & Shriver Maryland
Washington, D.C. Virginia |
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