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Ober|Kaler Health Law Alert - Spring 2005




In this Issue

From the Chair

Congratulations

Guide to Terms

Ober|Kaler in Print

OIG Activity
OIG Approves Six Gainsharing Arrangements

OIG Advisory Opinions

OIG 2005 Work Plan

CMS Developments
CMS Proposes Plan to Pay Unpaid Costs of Emergency Health Care

Trailblazer Fraud Alert Reveals Provider Identity Theft

Long Term Care
Discerning the New Pressure Ulcer Guidelines

Pharma
TAP Pharmaceuticals Settles with Lupron Consumers

Hospitals
Pay for Performance: Will Your Hospital Be Ready?

Nonphysician Practitioners
"Incident To" Rule Changes

Compliance
OIG Finalizes Supplemental Hospital Compliance Guidance

OIG's Supplemental Hospital CPG Looks at Hospital-based Physicians

OIG/AHLA Release Second Compliance Resource

Reimbursement
IRF "75 Percent Rule" Blocked

Correct Minor Errors and Omissions Without Appeals

Self-referral
Hospitals Meet "Under-development"

FCA
Courts Apply Strict Interpretation of Officer or Employee Under FCA

Lack of Pharmaceutical Recycling Guidance Precludes FCA Liability

Questionable Incentive Program Raises FCA Liability

Enforcement
Supreme Court Declares Sentencing Guidelines "Advisory"

Tax
IRS Penalizes Health System for PAC/Payroll Deduction Plan

Antitrust
DOJ/FTC Report on Antitrust in Health Care

Physican Focus
Physician Retention Arrangements: Stark and Antikickback Issues

Employment
Alien Certification Exemption to Avert Staffing Crisis

 

Discerning the New Pressure Ulcer Guidelines

Donna J. Senft
410-347-7336
djsenft@ober.com

This article also appeared in Provider, September 2005.

Although many articles have been written to discuss CMS's Guidance to Surveyors regarding F-tag 314, which relates to pressure ulcers, this article will view these new detailed guidelines from a risk management perspective. Transmittal 4, "Guidance to Surveyors for Long Term Care Facilities" was published on November 12, 2004, and was immediately effective. Even a facility with a comprehensive wound management program should carefully review its program and make necessary modifications based on the CMS guidelines. The guidelines go into great detail; for instance, they discuss the risk of using wheelchairs with a sling seat for prolonged sitting such as during activities and meals. Many wheelchair manufactures include a sling seat as a standard option, requiring additional expenditure to purchase a solid seat. As such, many facilities own sling seat wheelchairs and may not have considered the implications of the use of such wheelchairs when developing wound care policies and procedures.

Wound Assessment
Thorough clinical assessment is a critical first step to preventing a survey citation or quality-of-care allegation related to skin care and wound development. In our work with facilities, we have encountered situations where the nursing staff knew that a particular wound was, for example, a venous status ulcer, however, the medical record did not reflect the assessment and clinical decision-making to arrive at such a conclusion. When this occurs, a facility is left trying to defend its position by relying only on certain wound characteristics, such as location, and underlying medical diagnoses, e.g., diabetes or peripheral vascular disease.

Definitions of various types of wounds were added to the surveyor guidance under F-309, directing the surveyor to look for clinical terms that differentiate the wound from a pressure ulcer, especially when the wound has certain characteristics consistent with a pressure-caused wound. Facilities should review and, as needed, revise the forms utilized for documenting the resident's skin integrity and wound assessments. The form should cue the clinician to document all aspects required by the guidelines to differentiate pressure ulcers from other types of wounds. Even the heading of the form is significant. It may be difficult to convince a surveyor or federal prosecutor that a particular wound is not a pressure ulcer when it is documented on a form entitled "Pressure Sore Assessment."

In other cases we have observed, wound care is not provided to a resident who is experiencing multi-system organ failure or is in an end-of-life situation because the resident has refused treatment. Although the facility recognizes the resident's situation, it is not reflected in the medical record. This lack of documentation may occur when the facility has been discussing hospice care or other treatment options, yet the resident or health care decision-maker is not ready to make a decision so the record is silent. In addition to instructing facilities to document when a resident has multi- system organ failure or an end-stage condition, the guidelines instruct facilities to document the basis for refusing treatment and alternative treatment options when a resident refuses care. This would be especially important when the resident has not elected hospice treatment or otherwise indicated the desire for palliative care only.

Critical Period of Assessment
As indicated in the guidelines, it is critical that an initial assessment of a resident's skin condition and wound status be performed as soon after admission as is possible. The guidelines also highlight the importance of monitoring for changes in condition, which may trigger the need for pressure risk re-assessment. CMS recommends weekly skin assessments for the first four weeks of admission, referencing research that shows a significant number of pressure ulcers develop within this time period and asserting that many clinicians support weekly assessments for the first month of admission. These are not, however, the only times when the facility should be cognizant of the potential need to perform a total body skin assessment.

The guidelines indicate that a pressure ulcer may develop in as little as two to six hours. Therefore, a facility should consider the implications of residents leaving the facility for relatively short time periods, such as on family outings or to receive an outpatient test or procedure. Depending upon the resident's risk for developing pressure ulcers, mechanism of transport, and other factors, it may be necessary to perform a skin assessment upon the resident's return. Since deep tissue damage occurs first, nurses performing skin assessments need to understand the symptoms that may be indicative of a developing pressure ulcer. Besides documenting the resident's clinical condition upon return, it may be helpful to gather additional information about any potential mechanism of trauma during the period the resident was away from the facility. Contemporaneous documentation is more compelling than trying to gather evidence after being cited for causing an avoidable pressure ulcer.

Skin Care and Wound Treatment Protocols
The guidelines require facilities to establish treatment protocols "based on current standards of practice." More recently, there has been increased attention to evidence-based treatment, i.e., treatment with demonstrated success. The Internet has promoted the sharing of evidence-based clinical policies and protocols.

The CMS transmittal provides hyperlinks to some of the websites where wound care guidelines and protocols may be obtained. Additionally, manufacturers of skin care products or dressing supplies may be able to provide evidence-based clinical protocols or research studies demonstrating the efficacy of their products.

Deviation from the Guidelines for Valid Clinical Reasons
Situations may exist when strict adherence to the guidelines is not in the resident's best interest. For example, the guidelines instruct facilities to avoid "positioning the resident on an existing pressure ulcer" because of the "additional pressure on tissue that is already compromised." A resident with a sacral pressure ulcer who also has dysphagia may only be safe eating in an upright position. Balancing the resident's nutritional needs against the wound care needs, it may be clinically appropriate to have the resident sit to eat all meals. The care plan could reflect the best compromise including utilization of the appropriate pressure relieving cushion and immediate relief from sitting after meals.

When it is necessary and appropriate to deviate from the guidelines, facilities should be sure the medical record reflects the clinical assessment leading to the recom- mended care plan and evidence that the care plan is followed. For the example above, the record should reflect not only the dysphagia diagnosis and need to eat in an upright position, but also, the time period sitting upright and the use of a pressure-relieving device. It may be necessary to perform skin checks after sitting initially until the record reflects wound healing in conjunction with this total care plan.

Defending Facility Actions
Not only is it important to understand what the guidelines instruct facilities to do, it is equally important to know what inferences and conclusions are not supported by the guidelines. In discussing nutritional and hydration deficits, the guidelines indicate, "a low albumin level combined with the facility's lack of supplementation, for example, is not sufficient to cite a pressure ulcer deficiency." Additionally, the surveyors receive guidance regarding how to determine if a facility is in compliance and how to score a pressure ulcer citation.

By definition an unavoidable pressure ulcer is one that develops despite thorough evaluation and care planning based on the resident's clinical condition and risk factors, defined treatment interventions consistent with resident needs and standards of practice, and monitoring of the care plan with revisions provided as needed. Therefore, the guidelines indicate if a pressure ulcer develops when the facility recognized and assessed risk factors, designed and implemented pressure ulcer prevention strategies, monitored the resident's response to preventative measures, and revised approaches as necessary, the ulcer is unavoidable and the facility is in compliance. Even if all of these practices occurred, failure to document any of the facility's actions may affect its ability to reverse a citation or allegation.

With respect to severity scoring, the development of a single Stage II "avoidable" pressure ulcer is an example of a negative outcome that is not to be cited at an actual harm or G-level deficiency score. Surveyors may not be aware of all of the details of these guidelines and may cite such practice as actual harm.

In closing, this article is not intended to cover all of the critical aspects of these extensive guidelines, but instead offers a perspective that differs from that of many recent articles which are filled with warnings to facilities. Facilities should understand the risk implications but also need to be able to find the positive ways the guidelines may be used to justify the care and services provided and to demonstrate the facility was in compliance or did not harm a resident. s

Transmittal 4 is available at: www.cms.hhs.gov/manuals/pm_trans/R4SOM.pdf.

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