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Is Your HIPAA Compliance Program Ready?

The issuance of the regulations and administrative provisions promulgated as a result of the Health Information Portability and Accountability Act of 1996 (HIPAA) have once again added yet another set of complex requirements for long-term care industry compliance and concern.  Although the OIG mandates for Corporate Compliance were theoretically "voluntary," the new HIPAA guidelines now place paramount importance upon a facility's compliance program(s)...and HIPAA compliance is mandatory.  Among other critical topics, facilities now need to address via compliance programs and police such matters as electronic data transmission and interchange, all outside contracts with "business associates," privacy, security, confidentiality, consents, authorizations, preemption, and more.  Do you have a HIPAA program that fulfills the requirements of the April 14, 2002, deadline?  Do you know what a HIPAA compliance program should include?  Do you know how to perform a HIPAA assessment at your facility?  Do you know the difference between "consent" and "authorization" and who can grant each? Do you know how HIPAA interrelates to both your quality assurance and corporate compliance programs?  Do you know that HIPAA might now make corporate compliance judiciously "mandatory" rather than "voluntary?"  You now need to know these answers and more. Contact Gene Larrabee and Primus Care today for assistance in developing your HIPAA compliance program.

OIG Poses Challenges

Note -The Health Care Finance Administration has changed its name to the Center for Medicare and Medicaid Services (CMS).

CMS OBRA SURVEY INITIATIVES LOOM LARGE

As most long term care professionals are now aware, new survey protocols and procedures are being implemented by HCFA effective July 1, 1999. These new survey initiatives are complex and will most probably be put in place before they are finalized by HCFA. With the exception of F-226, there have been no regulatory revisions made (no new or revised F-tags) to facilitate HCFA’s desired changes. There have, however, been substantial changes to the State Operations Manual and to surveyor Interpretive Guidelines. It is the finalized language in these two documents that will not be available to the industry by July 1. 

It does appear as if draft language dated June 14, 1999, for the State Operations Manual will closely, if not identically, correspond to the final language once completed. Facilities should be aware this new language and the attendant survey initiatives do not necessarily replace previous survey protocols and procedures. These changes only affect those identified areas of revision and all other areas of the survey process should theoretically remain the same. In fact, HCFA considers these changes to be "procedural," rather than regulatory, as the changes are to the interpretive guidelines and not the regulations. The new investigative protocols which are part of the July 1, survey initiatives are seen as "added tools" to assist in the survey process and not supersede the previous regulations. 

Those areas identified for new surveyor emphasis encompass investigative protocols for nutrition and hydration, pressure ulcers, medication errors and drug therapy review, and abuse and neglect. Each of these identified areas will now have new protocols the surveyors will follow in conducting the survey. Specifically, there are seven new investigative protocols to be used by the surveyors and these seven are entitled and include: (1) Nursing Services, Sufficient Staffing; (2) Adverse Drug Reactions; (3) Pressure Sore/Ulcer; (4) Hydration; (5) Unintended Weight Loss (6) Dining and Food Service; and (7) Abuse Prohibition. These protocols will greatly expand the scrutiny each of these areas will receive during the survey process and will undoubtedly require facilities to develop new internal systems to address each new protocol issue. 

In addition to these new areas of emphasis, surveyors will now begin to extensively use a facility’s quality indicator review information as part of both the survey itself and survey preparation. This facet of the survey process has the potential to be far more wide-reaching than the initiatives listed in the previous paragraph. Of the thirty original quality indicators created by the Center For Health Systems Research at the University of Wisconsin, twenty four have been selected to comprise the Facility Quality Indicator Profile. This document will provide survey teams the status of facility quality indicators based upon information gleaned from the transmission of MDS forms. It will also provide comparative information that will allow the surveyor to evaluate a particular facility in comparison to the industry as a whole and identify percentile thresholds from which the survey teams may or may not proceed with more in depth analysis and review at the time of the survey. If the quality indicators show a facility has exceeded a quality indicator threshold or indicate a sentinel event, those specific indicators will be flagged for further survey review. HCFA has arbitrarily established the quality indicator threshold at the 75th percentile. 

The information transmitted on the MDS will also generate the Facility Characteristics report and the Resident Level Summary Report. The Facility Characteristics report will reflect general profile information about the facility and contrast that information to the facility comparison group. The Resident Level Summary report will list each facility resident and indicate those quality indicators present for each resident. The Resident Level Summary report will be used by surveyors as a primary means to identify and select survey sample residents. All three reports will be reviewed by surveyors during the offsite, pre-entrance conference to target areas of emphasis for survey review. Thus, the accuracy of the information contained in and transmitted as part of the MDS becomes more critical than ever before. 

The one new F-tag, F-226 concerns abuse prohibition and in a practical sense is not a new requirement. F-226 is now designated as that F-tag to be used to cite facilities for a failure to develop and properly implement necessary policies and procedures addressing abuse. Previously such citation was made under F-224. F-224 is now designated exclusively for citations involving the actual mistreatment or neglect of residents or the misappropriation of resident property. There has been no change in the regulatory language, just the addition of an F-tag number for citation designation. Facilities should note, however, that extensive new interpretive guidelines correspond to the new F-226. 

Historically the long term care industry has been and, to a great extent remains, reactive in its nature. The industry will make changes when some regulatory body mandates those changes, but it will not make them before changes are required. If one objectively takes a global view of the survey process, it becomes quite apparent that it is now a dynamic process and is in a state of continual change. It would seem perspicacious, therefore, for the industry to become proactive, begin to anticipate change before it is mandated, and begin to implement systems futuristically. That objective, global analysis of the OBRA quality based survey process should render at least three conclusions. 

First, there are three regulatory groupings that can result in findings of substandard quality and thus significantly impact a facility’s compliance status. Substandard care findings can be assigned via scope and severity to those F-Tags which comprise quality of care, quality of life, or resident behavior and facility practices (see Manual, page 126). As the current quality indicators address those issues regarding quality of care, it seems only logical that future quality indicators will be developed for quality of life and resident behavior and facility practices. Facilities might be wise to begin to develop their own quality indicators for these areas. 

The second conclusion that can be drawn from the trend(s) these HCFA revisions infer could have significantly long-reaching, precedent-establishing effects on the industry. For some time some HCFA officials have expressed the desire to have the interpretive guidelines and/or the State Operations Manual viewed on equal footing with the regulations. What this subtly accomplishes is to give the interpretive guidelines and the State Operations Manual the force of the regulation (and thus, the law) without having to adhere to or become subject to the review process that is required whenever an administrative agency promulgates new regulation(s). In effect, it would seem that is exactly what HCFA has done under these circumstances. Without changing the wording of any regulation, by revising and changing the interpretive guidelines and the survey protocols contained in the State Operations Manual, it appears that possibly HCFA has succeeded in changing the intent and meaning of the regulations without making any actual regulatory changes. 

The third and final conclusion that can be deduced from analyzing the survey process is most obvious when one examines survey trends and couples those trends with the survey system’s emphasis on quality based surveys, quality management systems, and quality assurance and assessment. The final piece to this quality based puzzle should be quality improvement. The ramifications of this assumption are unlike anything the industry has previously faced. The author will now make a bold prediction. With the availability of more and more facility comparative statistics, the expectation of the survey process will soon become improvement. If a facility cannot demonstrate improvement from one standard survey to the next, the facility will then be subject to citation for deficient practice(s). If that prediction is valid, and there appears to be every reason to believe it is, the industry must begin to realize that to survive it must adopt a futuristic vision to proactively anticipate future systemic trends, changes, and requirements. Put most simply, the future is NOW!

The most obvious precaution a facility can take to protect itself from the potential punitive consequences of the survey process is to establish a comprehensive and sophisticated quality management structure. Such a management structure entails far more that just the quarterly or monthly meeting of the quality assurance committee. If your facility does not have the components of a quality management structure in place (i.e., systemically designed policies and procedures; quality assurance, monitoring, and evaluating; and mechanisms for quality improvement), then it might behoove your facility to seek outside expertise to assist in designing a structure and accompanying systems that are specific for your facility. We suggest you contact Gene Larrabee for guidance and assistance in these matters. Mr. Larrabee can provide training designed exclusively for your facility staff that will help you implement those quality management mechanisms necessary to achieve and maintain substantial compliance. 

As indicated, these new survey changes are far reaching and complex. A thorough, detailed, and lengthy analysis of the new survey initiatives may be found herein under the section entitled "Manual Updates." This section of the website is available at no charge to any person who has purchased a copy of our manual, Achieving Substantial Compliance. If you have not purchased Achieving Substantial Compliance, information can be found on how to order under the heading referencing the manual on the blue toolbar. The manual updates may alone be worth the purchase price as they will provide not only information regarding the new survey protocols, they also provide an analysis of how these HCFA actions may affect facilities and include factors all facilities should be considering at this time. 

From time to time this website will provide long term care industry tips for your consideration. Here are some selected items for thought: 

• Why not seize control of the survey process in your facility? The OBRA system actually provides implicit means by which facilities can better control the survey process. Although it is obvious a facility will never be able to wrest entire control of the process from the survey team, there are a number of things judicious management can formulate and implement to better protect facility interests against findings of non-compliance. The most integral factor in defending a facility's interests is the development of a sophisticated quality assurance program and quality management structure. While all facilities now have active quality assurance committees, very few have established the proper legal foundation to insure the confidentiality of their records and work product. While it is true the regulations infer the surveyors cannot access a facility's quality assurance committee records, unless the facility's quality assurance plan is properly constructed with the recommended legal phrasing and language, the facility may not be insuring its records remain inaccessible and confidential. Moreover, in order to have a truly effective quality assurance program, a number of management mechanisms must be put in place to effectuate the best protection of the facility against deficiency citation. Contact Gene Larrabee for further suggestions regarding your quality assurance program and details about individually-designed quality assurance training sessions that may be held at your facility.
• Limit the surveyors' ability to interpret regulations against your interest. In "seizing control" of the survey process, facilities have more leeway than ever before to control what the survey teams may cite. By developing facility-specific policies and procedures that provide a facility's interpretation of a regulation, facilities can greatly pre-empt the surveyors' ability to have latitude in regulatory interpretation. Contact Gene Larrabee for guidance in how these policies and procedures may be best developed to protect your facility's best interests.
• Criminal actions are becoming more frequent. In conjunction with President Clinton's recent mandate to HCFA to increase the effectiveness of the regulatory oversight process, criminal actions against facilities are now becoming more common. Often these can commence without a facility's knowledge through the auspices of a grand jury probe. For example, a Midwestern facility is currently under grand jury investigation focusing on the quality of patient care, intimidation of witnesses, and obstruction of justice. This investigation, being conducted in a joint effort by the state attorney general and local county prosecutor, is occuring after the facility in question had been found to be in compliance upon resurvey. Meanwhile, in the southwest, in a civil action, a family was recently awarded a multi-million dollar settlement based on substandard care. In both criminal and civil actions such as these, the single factor that does or will bring the most harm upon the facility is the HCFA 2567. It is more critically important than ever before that plans of correction be constructed with the utmost care and include or are accompanied by documentation for informal dispute. Many long term care legal experts now strongly advise their clients to seek the assistance of outside expertise in filing plans of correction.
• Facilities should be prepared for surveyors at anytime. All long term care facilities should be aware HCFA has now issued a directive to state survey agencies that at least ten per cent of all inspections should occur during "non-business" hours. A small number of facilities across the country have had state survey teams arrive in the evening, during early morning hours, and on the weekends. Apparently, when these unexpected arrivals occur, one of the factors the surveyors consider are those procedures or policies in place at the facility for notification of facility administrators and directors of nursing. The ability of management level staff to arrive in response to surveyor presence may contribute to establishing an initial mindset on the part of the surveyors. Facilities should further keep in mind state survey teams are required to conduct an entrance conference. It would, therefore, seem judicious for facilities to have procedures set in place and staff well-trained or designated to satisfactorily appease surveyor requests during the initial hours of these "surprise" arrivals.
• Why is the Informal Dispute Resolution process so critically important? Many facilities have foregone the chance to avail themselves of IDR if, for no other reason, they perceive it as an exercise in futility. Many state health departments have not established truly independent and objective IDR mechanisms and, consequently, the IDR process only confirms surveyor findings. It is critical all facilities consider using IDR to dispute as many deficiency citations as possible. IDR is the only time during the survey process a facility is provided the opportunity to establish its position of defense. If you experience a poor survey which should happen to result in an administrative or federal hearing, you cannot establish your defense at the time of the hearing. You can only establish your position of defense at the time of the filing of the plan of correction and request for IDR. If you do not avail yourself of the IDR process, you may forfeit all future right to establish a position of defense based upon the facts of the survey. Without IDR, the position(s) taken by the surveyors on a facility’s HCFA 2567 will stand in perpetuity. This includes any future appeals you may want to make regarding repeat deficiencies. Again, IDR is critical because it is a facility’s one and only opportunity to establish a position of defense.
• Should I be concerned about corporate compliance? Each facility, under HCFA fraud and abuse regulations, has the affirmative responsibility to maintain corporate compliance. Corporate compliance is not the same as regulatory compliance within the survey process. Corporate compliance is an extremely specialized field within the law and facilities should not rely upon their corporate legal counsel for advice and direction unless your specializes in health care and long term care law. Most corporate entities that are multi-corporate structures today are likely to be out of compliance with corporate compliance requirements and not be aware of their non- compliance. An item as simple as a rebate from a purveyor from whom you have made a purchase may put you out of corporate compliance. Remember, you have the affirmative duty under the law to establish your own corporate compliance program.
• As more and more states finally become equipped to facilitate MDS transmittal as required by HCFA, the importance of properly and accurately completing the MDS significantly increases. As each state’s respective system becomes more sophisticated, these systems will generate statistical results that can be used by surveyors at the time of your survey. If your MDS information reflects aberrations from either norms within your area or regulatory expectations, you may face citation based upon information you yourself provide to state agencies. It is important to insure your documentation systems are established to protect your facility from citation which may result from MDS statistical irregularities. MDS review, therefore, becomes a vital consideration for a facility’s quality assurance process. Facilities may want to consider using AHCA’s newly developed facilitator program. (This is not an endorsement, paid or otherwise, of the AHCA product.)