CENTER SUBMITS COMMENTS TO CMS's proposed revision to nursing home survey process

November 14, 2001

Nancy Matheson, Ph.D.
Senior Research Scientist
American Institutes for Research
1000 Thomas Jefferson Street, N.W.
Washington, DC 20007-3541
(202) 342-5033 (fax)
nmatheson@air.org

Steven A. Pelovitz
Centers for Medicare & Medicaid Services
7500 Security Boulevard
S2-13-17
Baltimore, MD 21244-1850
(410) 786-0194 (fax)
Spelovitz@cms.hhs.org

Dear Dr. Matheson and Mr. Pelovitz:

The undersigned organizations are writing to express our strong opposition to the Centers for Medicare & Medicaid Services' proposed revisions to the State Operations Manual, particularly the new and dramatically changed guidance on scope levels. None of us was involved in any process to revise the definitions of scope and we had no notice that CMS was even considering revisions to the definitions until we received the draft in late September. We collectively urge CMS to withdraw the changes that revise the definitions of the three scope levels and the three categories that classify scope levels and, in cooperation with the undersigned organizations and others who are concerned about nursing home issues, to begin again the process of revising the definitions of scope in the State Operations Manual.

The new guidance on scope defines widespread as 75% or more of a facility's residents. New language describing Acategories@ to classify scope prohibits using the results of samples for deficiencies that are not easily or readily quantified. The effect of these two changes will be the prohibition against survey agencies' citing any quality of care or quality of life deficiencies as widespread.

A second major concern is the need for CMS to develop an additional severity level that reflects actual harm that is not immediate jeopardy. The four levels of harm that are currently used include two levels that reflect no harm (substantial compliance and no actual harm with the potential for more than minimal harm that is not immediate jeopardy) and two levels reflecting harm (actual harm and immediate jeopardy). The examples presented for specific F-tags, particularly in the activities area, illustrate the problem that occurs when the rules provide for only a single level reflecting harm that is not immediate jeopardy: a resident's expression of even serious concern or distress about the absence of meaningful activities is placed in a Anon-harm@ level of severity unless the resident expresses the desire to die from the lack of activities. The severity of deficiencies is inappropriately down coded from actual harm to no-harm.

The guidance on severity will lead to surveyors' citing deficiencies at a non-harm level even though actual harm to a resident has already occurred. The General Accounting Office and the minority staff of the House Committee on Government Reform have reported that the current survey system already cites deficiencies at lower levels than appropriate. The guidance on severity does not correct this problem or concern, but, rather, exacerbates it.

Finally, we are concerned that the narrative guidance, while generally excellent and very informative, is not always reflected accurately in the specific F-tag examples. In a few instances, the guidance is not internally consistent.

New definitions of scope

Our primary concern is that the proposed Manual changes will make it literally impossible for state survey agencies to cite quality of care, quality of life, and residents' rights deficiencies as widespread. No outcome-based deficiency could ever be cited as widespread, according to the new guidance, because no extrapolation from resident samples is permitted. CMS' position is inconsistent with federal law.

Use of a Acase-mix stratified sample@ is required by the nursing home reform law to determine compliance with quality of care and residents' rights requirements. Activities are specifically included in the list of services for which a case mix sample must be used. The portion of the draft that establishes three categories to identify scope (particularly category 3) violates the reform law by prohibiting surveyors from using the findings from samples when they cite deficiencies. It is internally inconsistent, misleading to the public, in violation of federal law, and poor public policy, to require use of a limited sample during the survey process and, simultaneously, to tell surveyors that they cannot base survey decisions on their findings from the sample.

If CMS insists on promulgating a new definition of widespread that requires that at least 75% of a facility's residents be found by surveyors to have been affected by a facility's practices, then it must also amend the survey protocol to require that survey teams review the care of every resident in the facility (and CMS must also pay survey agencies the costs of the expanded review).

While we understand that CMS expects an increased number of pattern-level deficiencies to be cited under the new guidance B an expectation that is likely to be true B that result does not justify or support the proposed changes. The designation of pattern-level deficiencies is so broad that it will not meaningfully distinguish among facilities.

Moreover, the changes will have significant additional effects. The proposed revisions will affect classifications of deficiencies as substandard quality of care (no F-level deficiencies will be substandard quality of care), will affect enforcement (less stringent remedies will be imposed for pattern deficiencies than for widespread deficiencies), and will make the information provided to the public about the scope of deficiencies highly misleading (by suggesting that care in nursing facilities is better than it actually is).

The proposed changes are not neutral and they are not benign. They will affect smaller facilities more significantly than larger facilities. No facilities with F-level deficiencies will be identified as providing substandard quality of care. Since one automatic consequence of such a designation is loss of authority to conduct nurse aide training, the proposed changes will lessen the quality of nurse aide training (and the quality of care provided to residents) by allowing facilities with F-level deficiencies to continue providing nurse aide training. The proposed changes will also minimize the perceived significance of deficiencies that are cited, making facilities appear to the public to have less pervasive deficiencies than they actually have. Not a single facility in the entire country will be publicly identified as having widespread quality of care deficiencies.

We also observe that CMS has been continually limiting the definition of Awidespread@ since July 1995, when the term was first introduced into the survey process.

The guidance and F-tags

With respect to the remainder of the document and the examples of particular F-tags, we are concerned that the guidance is not necessarily reflected in the specific F-tag examples. In a few instances, the guidance is not internally consistent. Some of the examples for specific F-tags at level 2 (the no-harm level) are appalling because they clearly reflect harm that has already occurred.

The lengthy discussion of pressure sores makes a number of significant points about the avoidability of most pressure sores and the individualized care that can prevent most pressure sores:

ACurrent literature continues to indicate that most pressure ulcers are avoidable.@ (Draft, page 50).

AThe presence of co-morbidities does not relieve the facility of the responsibility to try to do what it can to address the risk factors,@ id. 44.

Residents may require repositioning more often than every two hours, id. 45.

The Investigative Protocol directs surveyors to determine

. . . if the interventions and frequency are consistent with demonstrated resident need (e.g., whether the planned frequency of toileting is sufficient to keep the resident clean and dry) and recognized standards of practice (e.g., treatment techniques and infection control, staff competency, etc.)

Id. 48. This language recognizes the distinction between Ademonstrated resident need@ and Arecognized standards of practice@ and the need for facilities to comply with both for each resident.

Yet in discussing whether pressure sores are unavoidable, the draft says:

If the facility has accurately assessed the resident's condition, planned and consistently implemented interventions to prevent the development of pressure ulcers for those residents at risk or those with recurring Stage I ulcers, the facility is in compliance with this requirement.

Id. 51. This language seems facility-focused, rather than resident-focused. It does not adequately reflect the need for individualized care that might make Arecognized standards of practice@ insufficient to meet the needs of a particular resident.

We do not believe that a Stage I pressure sore should be called a level 2 deficiency (no actual harm with the potential for more than minimal harm that is not immediate jeopardy), as the draft proposes under ASpecific Considerations.@ Id. 56. If a pressure sore is avoidable, it is actual harm, under all circumstances.

We are also concerned, for the reasons discussed above, about CMS' scope guidance identifying

pressure sores as a category 3 (and therefore, making it impossible for surveyors to cite pressure sore deficiencies as widespread under any circumstances). Id. 57.

The guidance contains considerable information about how unusual urinary incontinence should be and what steps facilities need to take to reduce its incidence:

ARegardless of the resident's age and condition, urinary incontinence is not normal. Urinary incontinence is a symptom of a condition, and it is imperative that a comprehensive medical history and physical examination be conducted to determine the underlying condition that leads to the incontinence@ (id. 61).

AOSCAR (2001) data reveals [sic] that approximately 7% of nursing home residents have urinary catheters. Current literature indicates that a urinary catheter should be used only for a specific clinical condition which is being treated under physician supervision@ (id. 61).

AWhile not all residents will be appropriate for a program of rehabilitation or bladder retraining for urinary incontinence, current literature indicates that most residents can achieve some level of improvement for urinary incontinence with proper intervention@ (id. 63).

AImproved bladder control can occur even in the cognitively impaired individual@ (id. 65).

The guidance for defining scope of deficiencies under urinary incontinence does not reflect this information. ASpecific considerations@ for level 2 (no actual harm with potential for more than minimal harm that is not immediate jeopardy) includes Aindwelling catheter without medical justification and no complications@ and Aan indwelling catheter inserted for facility convenience@ (id. 77). These examples of a Ano harm@ deficiency are not consistent with the document's earlier statements. If Acurrent literature@ demonstrates that catheters Ashould be used only for a specific clinical condition which is being treated under physician supervision,@ then a facility's using an indwelling catheter Awithout medical justification@ or Afor facility convenience@ is unacceptable care and the deficiency must be cited at harm level 3 (actual harm).

The examples in level 2 for no actual harm are not acceptable. For example, the draft includes the following example:

A resident had an indwelling catheter because of Adistended bladder@ that was detected soon after a cerebrovascular accident. The catheter was leaking, and the resident was soaked with urine. The staff used an absorbent product to contain the urine. The resident's diagnosis of a stroke provided no justification for the use of a catheter and no assessments were performed to identify alternative methods to address urinary retention.

Draft 77. This example reflects clear actual harm and is inconsistent with the guidance in the text (ACurrent literature indicates that a urinary catheter should be used only for a specific clinical condition which is being treated under physician supervision.@ Id. 61.)

We have the same concerns about the next Ano-harm@ example:

A cognitively impaired resident returned to the facility from the hospital with an indwelling catheter. Six months later, the resident remained catherized even though there was no diagnosis to support the catheter's use. The facility stated that the family wanted it to remain in place.

Id. 77. The examples on page 78 are equally inconsistent with the guidance and are also inappropriately used to illustrate Ano harm@ deficiencies. These examples illustrate harm that has occurred.

The guidance on severity of activities deficiencies indicates that only when a resident expresses a desire to die from lack of activities (or explicitly says life is not worth living because of the lack of activities) should the survey team cite level 3 harm. If the resident expresses feelings of loneliness or says she feels like a child or is upset, then the deficiency is only level 2 (no actual harm with potential for more than minimal harm that is not immediate jeopardy). Id. 23-26. This guidance is unacceptable. Residents may express different levels of mental anguish, but all of the negative feelings expressed in the examples reflect actual harm that has already occurred to a resident and been expressed by a resident. Harm cannot be limited to an expressed wish for death.

The examples for level 2 (no actual harm with the potential for more than minimal harm that is not immediate jeopardy) are in fact deficiencies reflecting harm that has occurred:

For 3 days of the survey, an alert, oriented resident who was confined to bed, had one activity offering provided by facility staff. She was observed staring at the ceiling or wall during most of the day and expressed feelings of loneliness due to having nothing to do. There were no supplies or equipment in the room for self-initiated activities.

A resident with depression and mild dementia was observed making birdhouses with Popsicle sticks. He stated that the crafts made him feel like a child. His assessment indicates he had been a highly-ranking government official, a pilot, and a cabinetmaker. The activity care plan identifies no approaches that adapt his past interests to his current abilities.

A cognitively-impaired resident who can't speak for himself had an activity goal to participate in small group activities. There were no programs available for cognitively-impaired residents during the last 3 months because activity staff hours had been cut from 650 to 300 per 2-week pay period.

Id. 25.

These examples in the draft vividly demonstrate the problem with having only a single severity level expressing actual harm that is not immediate jeopardy: significant deficiencies will be down coded from actual harm to potential for harm.

We are also concerned, for the reasons discussed above, about CMS' express statement that activities may never be cited as widespread deficiencies. Id. 27. As pointed out above, the reform law requires that surveyors use a Acase mix stratified sample@ to determine compliance with requirements regarding activities.

Other concerns

The revised guidance in this draft does not incorporate the GAO's July 1998 recommendation to expand the sample size. Nor does the draft reflect any analysis of decisions by Administrative Law Judges. CMS must analyze the ALJs' decisions to understand areas and issues where ALJs reject deficiencies based on surveyors' correct application of the survey protocol. If ALJs identify problems with the protocol and refuse to affirm deficiencies based on its correct use, CMS must be aware of this and must take appropriate action.

Conclusion

The draft revisions to the State Operations Manual represent significant changes, and, in our view, significant retreats, from current policies, especially with respect to definitions and classifications of scope of deficiencies. The revisions call into question the survey protocol's use of resident samples to determine deficiencies and they violate the reform law's mandate to use samples in determining and identifying deficiencies.

The new examples of severity also bring strongly to our collective attention the inadequacy of the severity classifications, which essentially allow only a single level of actual harm and lead to an inappropriate down coding of deficiencies to a no-harm level.

Specific examples for particular F-tags raise questions as well. We believe any avoidable pressure sore must be cited at a harm level and we are concerned that residents' expressions of anguish or distress (in the activities tag) be treated seriously.

These concerns are serious and fundamental.

We urge you to reconsider these changes and not to implement them. In addition, we urge you to bring together a work group to discuss the definitions of scope and severity. These terms were originally developed in 1995 as a result of extensive meetings of a workgroup whose members included a large number of organizations that are interested and involved in nursing home issues. The survey process in general, and the definitions of scope and severity in particular, involve broad issues of public policy. General members of the public and the workgroup have the right to be involved in the development of this policy.

Thank you for the opportunity to comment on this draft.

Sincerely,

Toby S. Edelman
Center for Medicare Advocacy, Inc.

A Coalition for The Improvement of Nursing Homes (ACTION!) (Michigan)
Alabama Ombudsman Program
American Federation of State, County, and Municipal Employees (AFSCME)
Arkansas Advocates for Nursing Home Residents
Bet Tzedek Legal Services (Los Angeles, California)
California Advocates for Nursing Home Reform
Center for Advocacy for the Rights and Interests of the Elderly (CARIE)
      (Philadelphia, Pennsylvania)
Citizens Care (Louisiana)
D.C. Long-Term Care Ombudsman Office (Washington, DC)
Family Council Group, IHS Nursing Center, Grand Prairie, Texas
Friends and Relatives of Institutionalized Aged (New York)
Friends and Relatives of Nursing Home Residents (Harrisonburg, Virginia)
Kansas Advocates for Better Care
Michigan Campaign for Quality Care
National Academy of Elder Law Attorneys
National Senior Citizens Law Center
Nursing Home Community Coalition of New York State
Nursing Home Ombudsman Agency of the Bluegrass, Inc. (Kentucky)
Nursing Home Victims Coalition, Inc. (Austin, Texas)
Office of Ombudsman for Older Minnesotans
Texas Advocates for Nursing Home Reform
Texas Advocates for Nursing Home Residents
United Senior Action of Indiana
Wisconsin Board on Aging and Long-Term Care

Copyright © Center for Medicare Advocacy, Inc. 05/02/2008