New COPs are on the way
Becoming conversant with the QI-oriented regs is your safety net
Quality takes a front seat in the new proposed requirements for participation in Medicare, and that may be more important than you think. You may have been able to ignore the conditions of participation (COPs) in the past in view of the deemed status of the Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL, but you must pay close attention to them now. No one knows for sure what will happen until the COPs are finalized, but the quality issues in them might expand your obligation beyond simply meeting the Joint Commission’s standards. Medicare may now set its own standards for quality and tie those in with fraud and abuse standards as well.
It’s important for you to become familiar with the revised COPs. They are the underpinnings of your facility’s financial well-being. Read them now, and again when they are finalized in a year or so. You can find the proposed COPs on the Internet at http://www.access.gpo.gov/ su_docs/aces/aces140.html or at a Federal Depository library that houses the Federal Register.
"After reading through the newly proposed Medicare conditions of participation for hospitals, I’d say 90% relates to quality management issues," says Patrice Spath, ART, a health care quality consultant in Forest Grove, OR, and consulting editor of Hospital Peer Review.
Martin Merry, MD, a health care quality consultant in Exeter, NH, and a member of HPR’s editorial advisory board, says the COPs take on added significance when you get into trouble. Peer review organizations (PROs) have taken a user-friendly, educational approach to quality, and that’s good, he says, but it’s the government you must start paying more attention to because of its tough stance on compliance and fraud and abuse.
"Hospitals traditionally have taken the Joint Commission’s deemed status approach to Medicare certification," he says. "But things are changing now. We’re having to revise our response to Medicare rules. We have to alert ourselves more and more to new and revised regulations coming out of HCFA so we can compare them to the prior regulations for differences in tone."
Other quality professionals agree. "It’s extremely important that we keep in line with all the mandates of the federal government as well as of the accrediting agencies," warns Lynda L. Nemeth, administrative director of quality and case management at Norwalk (CT) Hospital. "The federal and state regulations come first in terms of keeping our license and in terms of getting paid by Medicare and Medicaid."
"The new regulations are very important to us," says Gail Apland, quality management coordinator at St. Mary’s Health Center in Jefferson City, MO. "If we want to continue to be reimbursed by Medicare, we’re going to have to meet whatever regulations HCFA issues. If HCFA is moving toward what the Joint Commission requires, we’re OK because that’s what we’re moving toward anyway." (See related article on JCAHO and HCFA dovetailing their efforts, above.)
Stay in the catbird seat, and watch how the government enforces the new COPs. No one knows at this point how aggressively the feds are going to push them.
The Health Care Financing Administration (HCFA) published its proposed requirements that hospitals must meet to participate in Medicare and Medicaid programs in the Dec. 19, 1997, issue of the Federal Register (Vol. 62, No. 244). See pp. 66,730-66,763 for the proposed new organizational format and the proposed COPs themselves. The requirements have changed substantially since their last incarnation in 1986.
Emphasizing 'how a patient experiences care'
"Work on the original requirements began in the early 1980s, so you can imagine how outdated they are," says Rachael Weinstein, RN, senior health insurance specialist at HCFA. "This is a major overhaul. We wanted to move more toward quality improvement and more toward how a patient experiences care in a hospital."
The COPs, according to Donna E. Shalala, Secretary of the federal Department of Health and Human Services, lean away from process and focus on results. In a recent statement, she said, "We’re telling hospitals they must monitor the quality of care they provide, improve that quality, and document that improvement." But the new rules do encourage flexibility in meeting quality standards. (See the related articles on QA and PI requirements and HCFA’s new patient-centered approach, above and p. 44.)
The focus now is on a cross-functional view of patient care and its outcomes, rather than on procedural requirements. "We revamped the conditions to get them in the outcome mode," continues Weinstein. "That’s where the field is, and we need to get there and away from structure- process measures."
What does this mean for you? Now the federal government seems to be trying to achieve broad-based improvement in the quality of care furnished through its programs. The new COPs’ focus on measurement of hospital care may lead you to believe you’ll be encumbered by procedural burdens. But the burden for compliance may be shifting to you from the shoulders of admissions and billing staff. The new quality element will bring you closer than you ever thought you’d be to Medicare regulations and activities.
Changes in the rules should result in fewer compliance surveys, and a reduced need for the government to threaten hospitals or take actions that could jeopardize a hospital’s reputation, financial viability, and participation in the Medicare and Medicaid programs. These changes are indicative of a fundamental change in HCFA’s regulatory approach a shared commitment between HCFA and Medicare providers to achieve improvements in the quality of care furnished to patients. The new COPs give hospitals internal responsibility for improving their performance, rather than relying on prescriptive requirements that are enforced through the punitive aspects of the survey process.
Process-oriented requirements are included only where they ensure desired outcomes or are necessary to deter or prevent fraud and abuse. The new rules streamline and consolidate old regulations. For example, they make clear that a hospital’s governing body is responsible for management, provision of care, and compliance with COPs, but drop requirements on how the governing body must be structured. In addition, rules that dictate medical staff organization are eliminated.
The rules, as they now stand, are organized according to the types of services a hospital offers and include specific, process-oriented requirements for each hospital service or department. The existing COPs do not provide patient-centered, outcome-oriented standards, nor do they provide for the operation of quality assessment (QA) or performance improvement (PI) programs. Since the current conditions were developed, significant innovations in hospital patient care delivery systems and QA practices have emerged, as evidenced by the Joint Commission’s recent revision of its accreditation standards and redesign of its survey process.
An interdisciplinary team approach is essential to the new rules. The number of conditions is reduced, and the document deletes process requirements that are not specifically mandated by statute or believed likely to produce outcomes vital to the protection of patient safety. (Proposed deleted requirements are listed on p. 66,753 of the Dec. 19, 1997, issue of the Federal Register.)
For example, the requirement that patients receive medications appropriately as prescribed remains basically unchanged, but the COPs no longer require a hospital to make a written description of its laboratory services available to medical staff. They continue to require, however, that a hospital provide laboratory services necessary to meet its patients’ needs, and they specify under the proposed QA and PI condition that a hospital’s QA and PI program include evaluation of the laboratory’s diagnostic services.
The practical effect of this approach is to stimulate hospitals to find and fix their own performance problems, and to continuously strive to improve patient outcomes and satisfaction, as well as efficiency and economy.
In no way does this mean you will be able to be less diligent once these COPs come into effect. In fact, the COPs’ enforceability is strengthened because their requirement for a program of continuous QA and PI increases performance expectations for hospitals in terms of achieving needed and desired outcomes and increased patient satisfaction.
The proposed rule specifies that HCFA may terminate the participation agreement of a hospital, skilled nursing facility, home health agency, or other provider if the provider refuses to allow access to its facilities or examination of its operations or records by or on behalf of HCFA, as necessary to verify that it is complying with the Medicare law and regulations and the terms of its provider agreement.
Noncompliance results in deemed status loss
If there’s a complaint that alleges noncompliance with a Medicare COP, HCFA has the authority to go into an accredited hospital and investigate. If a condition is not met, HCFA no longer recognizes the deemed status of that hospital, even though they may still be accredited. "We disregard the deemed status and put that facility under state monitoring until the Medicare conditions are met," Weinstein explains. "Once they’re met, the facility goes back under the Joint Commission."
The new requirements empower the federal government as well as state Medicaid agencies to compel improved performance or termination of an organization’s participation if it fails to correct seriously deficient performance. Under the current regulations, termination actions are initiated based on the evidence found during the survey. There will be no changes in that regard in applying the new COPs. If HCFA seeks a termination, it could be successful at arguing that, based on the evidence found during a survey, the requirements were not met even though a hospital may argue that its performance met the regulatory standards.
HCFA invited public comment on this fundamental shift in its regulatory approach. The agency was especially interested in advice on how to improve its new approach and what flexibility could be added. Once the comments came in, HCFA started analyzing them and working on a final rule. "The intention is to try to get something out within a year," says Weinstein. The current regulations are in effect until the final rule is published.
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