According to the Centers for Medicare & Medicaid Services (CMS), the increase in case mix weights from 1.3060 to 1.3085 between 2007 and 2008 can be attributed to the "unexpected" upsurge in the average number of therapy visits per episode. CMS accredits the shift in therapy visit levels to home health agencies "padding treatment plans" to reach the new, therapy visit thresholds above 13 visits. In the Proposed Rule, formally published in the Federal Register July 23, CMS has proposed new therapy service regulations to address the "unintended consequences" of higher therapy thresholds in order to clarify therapy coverage criteria and slow the rate of nominal growth. Today, we will share the National Association for Home Care and Hospice's analysis of the new therapy criteria proposed by CMS.

According to current regulations:

• Therapy must be related directly and specifically to a treatment regimen ordered by physician and designed to treat a beneficiary's illness or injury
• The clinical record must include a plan of care that describes the course of therapy based on the patient's functional assessment and must document the need for the course of therapy described in the plan of care.
• The record must include how the therapy -- which must be provided for a patient's illness or injury -- is in accordance with accepted standards of practice
• Objective, measurable treatment goals relating to the patient's illness or injury, and in accordance with accepted standard of clinical practice, must be described in the plan of care
• The plan also must include successive functional assessments that would enable comparison of successive measurements of therapy progress. *CMS suggests the use of OASIS functional assessment items or other commercially available therapy outcomes instruments for conducting the functional assessments

Additionally, CMS proposes periodic successive functional assessment time points in regulations at 42 CFR §409.44(c)(2)(i) as well as documentation of these assessments and progress to ensure that patients remain eligible for the benefit:

• These assessments would be required to be performed by a qualified therapist (rather than a therapy assistant)
• Reassessments, which would be documented in the clinical record, would need to be carried out by the qualified therapist to determine whether services should continue on the 13th and 19th visit and every 30 days
• Objective measurement of physical function and progress toward goals would be carried out to determine whether services should continue or cease to be covered
• In cases where improvement is anticipated, the clinical record would be required to include a clinically supportable statement of anticipated improvement in a reasonable and predictable time, unless services are for maintenance therapy

Consideration of therapy assistant documentation would be allowed to supplement the assessment by the qualified therapist. Required therapy assistant documentation would include:

• Date written
• Assistant signature and job title
• Objective measurements (preferred) or description of changes in status relative to each goal currently being addressed (if any)

However, clinical judgment by a therapy assistant would not be allowed. Plans for continuing or discontinuing treatment, or treatment plan revisions with changes in goals or discharge, would be based on qualified therapist evaluation results. If therapy is to continue, there must be:

• Documentation of objective evidence of improvement
• Or, a clinically supportable statement of expectations that the patient's potential to improve in response to therapy or that maximum improvement is yet to be attained in reasonable and generally predictable period of time

CMS proposed to clarify regulations at 42 CFR §409.44(c)(2)(iii) by adding that:

• There must be material improvement
• The clinical record must demonstrate functional improvements that are ongoing and of practical value when measured against the patient's condition at the start of treatment
• Covered therapy services should be rehabilitative therapy or maintenance therapy

CMS defines "rehabilitative therapy" as requiring the skills of a therapist, with recovery or improvement in function and, when possible, restoration to previous level of health and well-being. If a patient's rehabilitation potential is insignificant in relation to extent and duration of therapy services required to achieve potential, therapy would not be considered reasonable and necessary and would not be covered. CMS specifically identified therapy services as not reasonable and necessary where there is a transient and easily reversible loss or reduction of function (e.g., temporary weakness post surgery).

Criteria for covered maintenance programs were spelled out as services that require the specialized skill, knowledge, and judgment of a therapist for developing a maintenance program, and to:

• Design or establish the plan to ensure patient safety
• Train patients' family members and/or unskilled personnel in carrying out the maintenance plan
• Make periodic reevaluations of the plan

Covered maintenance therapy would be limited to the last visits for rehabilitative treatment or, when provided during an episode, based on skilled nursing as the qualifying service. Once a program is established, the maintenance therapy would normally be carried out by the patient or caregiver, unless the clinical condition of the patient requires the use of complex and sophisticated therapy procedures to be delivered by the therapist.

Finally, §409.44(c)(2)(iv) relates to the amount, frequency, and duration of therapy services. CMS proposed clarifying this regulation to mean that the amount, frequency, and duration of therapy services must be reasonable and necessary as determined by a qualified therapist and/or physician, using accepted standards of practice and based on the patient's condition.

What are your thoughts about these proposed changes?