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January 12, 2009

Centers for Medicare & Medicaid Services

Office of Strategic Operations and Regulatory Affairs

Division of Regulation Development

Attention: Document Identifier/OMB Control Number 0938-0760

Room CA-26-05

7500 Security Boulevard

Baltimore, MD 21244-1850

I am writing to comment on the proposed changes to the Outcome and
Assessment Information Set, referred to as OASIS-C, noticed in the
November 14, 2008 Federal Register. Document Identifier: CMS--R--245
(OMB# 0938--0760)

I support the use of OASIS as a comprehensive assessment tool and the
OASIS reports as an effective measure to improve quality care to
patients. However, I have the following comments regarding the OASIS-C
changes.

***Concern**:* **M0102** Date of Referral

***Suggestion for Change*:** Define the date of referral. Suggestions
include altering item to read "Indicate the ordered date the agency is
to initiate homecare." Differentiate between an inquiry about services
and an actual referral for services. Not all referrals come from a
physician so eliminate the word physician.

***Rationale**:* .Clarification is necessary for consistent practice
among agencies. Starting the services is not always within the home care
provider's control. For example, providers may be waiting for
authorization from Medicare Advantage programs which may delay the start
of care; sometimes referrals are made while the patient is still
hospitalized and home care is not able to start care for an extended
period of time; and sometimes patients make the request not be seen on a
certain day, also delaying the start of services. Provide direction for
how agencies are to answer this question when the initial physician's
order start of care is delayed. Does the date an agency updates the
physician on the patient's availability for start of care become the
referral date?

***Concern:* MO104** Date of Physician-ordered start of care

***Suggestion for change:*** eliminate this item. It is already recorded
on the 485.

***Rationale:*** If MO102 and MO104 are not within the 48 hour time
frame, it would set an agency up for an audit without any further
documentation that would support going beyond the initial 48 hours as
indicated above. Back office operations should not be integrated into
patient care.

***Concern**:* **M1010 & 1012** Inpatient Diagnosis and ICD Code

***Suggestion for Change***: Eliminate this requirement. If CMS needs
the data it is available from the hospitals.

***Rationale**:* Not all institutions make this information available in
a timely manner. Home health providers do not have access to this
information without the timely cooperation of the institution from which
the patient is discharged. This is an undue burden and unrealistic
expectation because final hospital coding often does not occur until the
hospital generates the bill. It is not realistic for home care
clinicians to have knowledge of the coding requirements for inpatient
facilities; requiring them to enter this information with insufficient
or completed data from referrals sources will result in errors in a
patient's medical record.

***Concern**:* **M1014** Medical or Treatment Regimen Change

***Suggestion for Change**:* Eliminate this item

***Rationale**:* This information is collected in other M0 items

***Concern**:* **M1032** Frailty Indicators

***Suggestion for Change***: Define unstable vital signs and clarify
what is debilitating pain, recent mental health change and what
constitutes a decline in functional status. Include items identified
from home health agencies' work with the QIOs as included on the
Hospitalization Risk Assessment Form at
[www.homehealthquality.org](http://www.homehealthquality.org/) web site.
The presence of high risk chronic diagnoses place a patient at risk for
rehospitalization and speak to the fraility of their overall status.
These include the diagnoses of CHF, diabetes, COPD, and chronic ulcers.
Antibiotic resistant infections are an increasing challenge and should
be included in this category. Environmental conditions or personal
attributes such as low socioeconomic status, low literacy, inadequate
support network, poor prognosis, shortened life expectancy, inability to
manage own medications are all common in the home care population and
are contributing factors to the frailty of the patients served.
Eliminate this item from SOC

***Rationale**:* At providers will not have historical data on vitals
signs and it is unlikely that vital signs are monitored and recorded by
patients/families. This makes it difficult to determine whether or not
the vital signs are stable or unstable. What is stable for one patient
may not be for another. Additionally, for consistent practice within the
industry, it is imperative to have concise definitions for stable vital
signs, debilitating pain, mental health changes and functional decline.
Unclear instructions and definitions will result in unreliable data. Of
concern also is that the frailty indicators are not measurable and
"other" data would be clinically significant to the patient's home care
episode but would not be retrievable from a text field.

***Concern**:* **M1034** Stability Prognosis

***Suggestion for Change***: Eliminate.

***Rationale**:* This language is similar to M0280 except that the
predicted death time has changed. Providers should not have to guess at
time of death. This leaves too much room for individual interpretations
so data would not be useful.

***Concern**:* **M1038** Guidelines for Physician Notification

***Suggestion for Change***: Delete this item

***Rationale**:* Physicians already report excessive paperwork from the
home care industry. Parameters will likely be different for each
patient, depending on history and current health status. Physicians most
likely will hesitate to provide this for individual patients. This seems
excessively burdensome for providers and physicians. Additionally,
surveyors are likely to use this as a reason for survey citation if it
is not available on [all]{.underline} patients. Ultimately, deciding
parameters for individual patients is a physician responsibility and
therefore not controllable by a provider. Eliminate the need for
parameters for each patient. Home care clinicians are already required
to notify a physician about changes in patient conditions that may
impact the plan of care. There is no regulatory requirement for
parameters.  Not every patient requires parameters, and, if they are
necessary, it can take time to establish them making it unrealistic to
establish them at the start of care.

***Concern**:* **M1040 through M1055** Vaccinations

***Suggestion for Change***: Clarify through CMS instructions that
providers will not be mandated to provide vaccinations without payment
for such. Eliminate "from your agency" verbiage and remove #1 and 2 in
M1045.

***Rationale**:* It is important to verify vaccination. However,
providers should not have to assume the financial and resource burden of
vaccination administration. There are more efficient ways to ensure
vaccinations. Health Maintenance should be between the patient and
physician, Home Health should not be used to drive physician behaviors.

***Concern**:* **M1242** Formal Pain Assessment

***Suggestion for Change***: Make suggestions and list appropriate
standardized assessment tools for pain. Eliminate this question on SOC.

***Rationale**:* The physician-ordered plan of care is not yet
established at the time of SOC OASIS assessment since this time is
actually a data-gathering time on which the clinician bases the plan of
care. Additionally, the use of one or two standardized assessment tools
will help decrease data variance that is collected by providers. This
question is about an agency process and comprehensive assessment tools,
not about the patient plan of care. If a standardized pain assessment
should be used, it should just be mandated to be done using a particular
tool and not asked on every SOC assessment

***Concern**:* **M1300** **- M1306** - Pressure Ulcer Assessment

***Suggestion for Change***: Extend the SOC OASIS assessment time frame
from 5 days to 7 days to allow collaboration between disciplines and to
determine ability and availability of caregivers as well as the most
effective wound care regimen.

***Rationale**:* What if PT or a weekend person is admitting -- does the
assessment need to be done right away at SOC? It is unrealistic to get
all of this done in the 5-day time frame. Consultation with staff
outside the home care agency, for example a wound healing clinic, is
often necessary to gather all pertinent clinical information. Again,
this question is about an agency process and comprehensive assessment
tools, not about the patient plan of care. If a standardized pressure
ulcer assessment should be used, it should be mandated to be done using
a particular tool and not asked on every SOC assessment.

***Concern**:* **M1312** - **M1314** Pressure Ulcer Length & Width

***Suggestion for Change***: Eliminate both items

***Rationale**:* Requiring length and width of the wound does not meet
the guidelines for measurement and assessment as established by the
Wound, Ostomy and Continence Nurses Society (WOCN). This question does
not ask for the components of a complete wound assessment; therefore
clinicians will be required to complete redundant documentation in order
to accurately document the wound condition. Providing only a length and
width of a wound does not provide an accurate accounting of a wound
status and is not best clinical practice. WOCN guidelines for wound
measurement include a length that is measured at 12 o'clock to 6 o'clock
with 12 o'clock always being toward the patient's head. Width is
measured side to side from 3 o'clock to 9 o' clock. Simply asking for
length and width does not support the guidelines.

***Concern**:* **M1320** Status of Most Problematic Pressure Ulcer

***Suggestion for Change***: Clarify that this pertains only to stages 3
and 4

***Rationale**:* A healed stage 1 or 2 would no longer be considered a
pressure ulcer.

***Concern**:* **M1326** Pressure Ulcer Intervention

***Suggestion for Change***: Eliminate this item.

***Rationale**:* Moisture retentive dressings are noted on the 485 as
supplies. It is in the home care clinician's area of expertise to
recommend a wound treatment; however, the physician makes the final
determination regarding orders for moisture retentive dressings.
Physicians need be responsible for ordering such dressings.

***Concern**:* **M1328** Pressure Ulcer Intervention

***Suggestion for Change***: Eliminate this item

***Rationale**:* Moisture retentive dressings are noted on the 485 as
supplies. It is in the home care clinician's area of expertise to
recommend a wound treatment; however, the physician makes the final
determination regarding orders for moisture retentive dressings.
Physicians need be responsible for ordering such dressings. It is not
the home care clinician's area of expertise or scope of practice to
determine the use of moisture retentive dressings. Physicians need be
responsible for ordering such dressings.

***Concern**:* **M1360** Diabetic Foot Care Plan

***Suggestion for Change***: Do not collect this at start of care.

***Rationale**:* The physician-ordered plan of care is not yet
established at the time of SOC OASIS assessment since this time is
actually a data-gathering time on which the clinician bases the plan of
care.

***Concern**:* **M1500** Symptoms of Heart Failure

***Suggestion for Change***: Eliminate this item.

***Rationale:*** What if a therapist is doing an assessment and the
patient has this diagnosis, even if it is not the primary or secondary
diagnosis, how would you expect a therapist to have enough knowledge to
answer this question, or if the nurse has been discontinued, to have
knowledge of what transpired during that episode of care without doing a
chart review.

***Concern**:* **M1730** Depression Screening

***Suggestion for Change***: Offer suggestions for specific screening
tools

***Rationale**:* Clinicians need to use a standardized screening tool in
order to collect and report on standardize data. Comparison across
patients will be less accurate if individual providers are using a wide
variety of screening tools.

***Concern**:* **M1734** Depression Intervention Plan

***Suggestion for Change***: Eliminate this from SOC.

***Rationale**:* The physician-ordered plan of care is not yet
established at the time of SOC OASIS assessment since this time is
actually a data-gathering time on which the clinician bases the plan of
care.

***Concern**:* **M1880** Change in Mobility

***Suggestion for Change***: Eliminate this item

***Rationale**:* What if the patient is better at transferring but not
at ambulation -- how should the question be answered? This is a very
subjective assessment. Patients most likely will be worse than prior
level of functioning if they are in need of home care services. What if
they are worse as a result of surgery -- is that considered an injury or
illness onset? Various aspects of this item are unclear and likely will
result in confusion and inaccurate answers.

***Concern**:* **M1890** Change in Self-care Ability

***Suggestion for Change***: Eliminate this item

***Rationale**:* What if the patient is better at dressing but not at
bathing -- how should the question be answered? This is a very
subjective assessment. Patients most likely will be worse than prior
level of functioning if they are in need of home care services. Various
aspects of this item are unclear and likely will result in confusion and
inaccurate answers

***Concern**:* **M1910** Ability to use Telephone

***Suggestion for Change***: Eliminate this item

***Rationale**:* This assessment is covered in an emergency plan and
safety assessment.

***Concern**:* **M1920** Change in Ability to Perform Household Tasks

***Suggestion for Change***: Eliminate this item

***Rationale**:* What if the patient is better at meal preparation but
not at laundry -- how should the question be answered? This is a very
subjective assessment. Patients most likely will be worse than prior
level of functioning if they are in need of home care services. The
question is too broad to achieve consistent and meaningful data.

***Concern**:* **M1930** Has patient had multi-factor Falls Risk
Assessment

***Suggestion for Change***: Recommend a standardized falls risk
assessment.

***Rationale**:* In order to have consistent data collection and
comparison across patients and agencies, it is important for clinicians
to collect data in a consistent manner.

***Concern**:* **M1940** Falls Risk Assessment Intervention

***Suggestion for Change***: Do not require this at SOC

***Rationale**:* The physician-ordered plan of care is not yet
established at the time of SOC OASIS assessment since this time is
actually a data-gathering time on which the clinician bases the plan of
care.

***Concern**:* **M2002** Medication Follow-up

***Suggestion for Change***: Eliminate the need to contact the physician
within one day and clarify what is considered "contacted" -- does that
mean a message has been left via phone, a fax has been sent, the home
care clinician contacted the physician's nurse or other staff? Define
clinically significant. Does "contacted within one calendar day to
resolve clinically significant medication issues" imply that both
contact *and* resolution is expected in one day, or is the intent of the
question to show contact within one day?

***Rationale**:* What if the person completing the OASIS assessment
isn't the same person doing the follow-up -- does this result in 2
clinicians completing the OASIS assessment? What if the physician is
contacted but nothing is resolved -- what is the CMS expectation?
Consider the discharge disposition for patients in assisted living
facilities. The risk adjustment is inadequate.  Patients move to
assisted living BECAUSE they can\'t manage their medications and/or
ADLs.  It is unlikely they will recover the abilities and show
improvement during a Medicare episode. This is especially problematic if
the Assisted Living facility has a policy requiring the AL staff to
administer all medications. This skews outcomes for this population. Is
a pharmacist considered a primary care practitioner? What about weekend
admissions -- it is unlikely that the issue would be resolved in one
day. Ability to "resolve" is dependent upon willingness and availability
of practitioners outside of the home care provider's control. Providers
should not be expected to resolve something that is outside of the scope
of practice (ordering medications).

***Concern**:* **M2004** Medication Interventions

***Suggestion for Change***: Eliminate this item

***Rationale**:* It is unrealistic to expect the discharging or
transferring clinician to know all of this without reviewing the entire
medical record including looking at previous OASIS assessments. This is
burdensome and time consuming to have to review an entire episode to
make this determination. Additionally, previous instructions did not
allow a "look-back" on OASIS -- are those instructions no longer valid?

***Concern**:* **M2020** Management of Oral Medications

***Suggestion for Change***: Go back to the question asking only about
[prescription]{.underline} medications (not [all]{.underline}
medications) and eliminate previous instructions to mark the patient as
independent if taking the majority of medications. Further clarify how
to answer the item choices -- what if both 1 and 2 pertain -- how should
the question be answered?

***Rationale**:* The actual medication has an impact on the patient's
health status. For example, if a patient is taking Colace and a vitamin
and remembers to take them but is also taking Digoxin but forgets to
take it, the current assessment instructions would be to mark the
patient as independent. In general, compliance with and ability to take
[prescription]{.underline} medications impacts the outcome far greater
than over-the-counter medications. Additionally, M2040 refers to all
[prescribed]{.underline} medications (including oral) when assessing a
change in the management of medications. The difference in M02020 and
M02040 is confusing and inconsistent.

***Concern**:* **M2110** Types and Sources of Assistance Matrix

***Suggestion for Change***: Clarify how to answer this question. For
example, in item a, what if the patient can do some of the tasks and not
others? If they need help, does [frequency]{.underline} impact the
patient?

***Rationale**:* Lack of direction will result in inconsistent and
unreliable data.

[Other general comments and concerns:]{.underline}

I am concerned that there were only 11 pilot agencies. This is not
statistically significant. There are over 9,000 Medicare-certified
providers. I suggest pilot studies on a much larger scale in order
determine the feasibility and usefulness of the proposed OASIS changes.

Please also clarify what previous instructions still apply or no longer
apply (i.e.: majority of the time, day of assessment etc.)

Expand the time frame for OASIS assessment completion to 7 days.
Completion of OASIS assessment is burdensome for the patient in its
current form and will become increasingly exhausting for the patient as
all of the other assessments are added. Additionally, allow the
recertification to be completed within the last 2 weeks of the
certification period. This is less intrusive for the patient and more
realistic for the provider. Excessive unbillable visits are being made
in order to complete the assessment within the last five days of the
certification period. The five-day completion requirement is burdensome
to the provider in this time of worker shortages.

It will take considerable time and resources, initially and long-term,
to implement these changes.  With all of the other home care changes,
this change will be overwhelming to clinicians. Already we are seeing
clinicians leaving home care due to excessive paperwork. Adding length
and completion time to an already cumbersome document is not acceptable.
Any future changes to the OASIS assessment should be done in a more
comprehensive manner, across care settings, and in conjunction with CMS
implementation of the tool and process for the Post Acute Care
Assessment.

Instead of asking if standardized assessment tools have been completed
to assess pain and risks for skin breakdown, add a tool into the
assessment that is approved by nationally recognized experts. This will
prevent the need to duplicate documentation in more than one area of the
clinical record since many agencies already have tools like the Braden
scale and pain assessment scales as requirements in their documentation.
This would also be beneficial for national benchmarking.

Please carefully consider our concerns before proceeding with the plan
to change the OASIS as proposed.

Sincerely,

Karen Riddle, MA, OTR/L, COS-C, Rehab Supervisor

North Memorial Home Health and Hospice

3500 France Ave N, Suite 101

Robbinsdale, MN 55422