The Centers for Medicare & Medicaid Services (CMS) issued new regulations on November 17th regarding coverage for home health services. The new regulations clarify Medicare coverage for home health services, including physical therapy, occupational therapy and speech-language pathology services. The regulations are effective January 1, 2011; however, since they clarify rather than change coverage rules, they are also applicable to services prior to that time.
Most importantly for people with long-term conditions, the new regulations “clarify” that skilled care does include services that are intended to maintain a person’s condition and that no “rules of thumb” should be used to deny care – including rules that require restoration potential.  The regulations state:
“Rules of thumb” in the Medicare medical review process are prohibited. … Any “rules of thumb” that would declare a claim not covered solely on the basis of elements, such as lack of restoration potential, … or degree of stability, is [sic] unacceptable without individual review of all pertinent facts.
To determine whether a service is skilled, and therefore coverable, the new regulations direct decision-makers to review accepted standards of clinical practice and to consider whether a professional is needed for the service to be safe and effective for the particular beneficiary. These considerations, rather than the ability to improve, are the key factors to be considered in making coverage determinations. The rules state that they do not alter coverage, but rather provide additional detail for care planning, assessment, and reassessment. They should help advocates in their efforts to ensure that necessary services are covered, particularly for people with chronic conditions.
To successfully use the new rules to help obtain Medicare coverage, it will be important for advocates to forge alliances with their clients’ care providers to make sure that care plans are comprehensive, well-documented, and reflect the specific needs and therapeutic goals of the individual. In this respect, the care plan can be an advocacy tool as well as a necessary treatment guide.
Improvement Not Required for Home Health Therapy
One of the most important aspects of the revised home health coverage regulations includes a more detailed explanation clarifying when Medicare covers establishment or performance of therapy in the context of a maintenance program. The regulation states:
The unique clinical condition of a patient may require the specialized skills of a qualified therapist to perform a safe and effective maintenance program required in connection with the patient’s specific illness or injury. When the clinical condition of the patient is such that the complexity of the therapy services required to maintain function involve the use of complex and sophisticated therapy procedures…by the therapist… or the clinical condition of the patient is such that the complexity of the therapy services required to maintain function must be delivered by the therapist… to ensure the patient’s safety and to provide an effective maintenance program, then those reasonable and necessary services shall be covered. (emphasis added)
In response to the many comments from advocacy organizations, CMS eliminated many references to the requirements of “improvement” or “progress” that were initially proposed in the therapy coverage regulations. CMS acknowledged that while progress might be an indication of effective therapy, it was not the sole evidence that therapy was necessary. Instead the coverage criteria needed to focus on the inherent complexity of the therapy services needed by the patient. As a result, several references in the text to improvement in function and progress were replaced in the final version with references to effectiveness of treatment. The regulations now clearly state that skilled, Medicare-coverable therapy does not require progress or improvement. In addition, in the places where the regulations retain the requirement that progress be made (for other forms of non-maintenance therapy), specific exceptions exist if the therapy meets the definition for maintenance.
Finally the regulations now specifically recognize that therapy for a maintenance program is reasonable and necessary and covered by Medicare. The preamble states:
Regarding the comment that the proposed regulation does not define “reasonable and necessary” in a way that clearly provides for coverage of maintenance therapy,…[i]n these revisions we describe that therapy can be considered reasonable and necessary when the criteria for maintenance therapy are met.
The final version of the regulations clearly acknowledges that a therapy maintenance program may be reasonable and necessary without regard to progress:
The amount, frequency, and duration of the services must be reasonable and necessary….
(B) …If progress cannot be measured, …therapy services cease to be covered except when… [m]aintenance therapy is needed. (emphasis added)
The final version of 42 CFR §409.44(c) contains additional language indicating when Medicare will cover therapy for beneficiaries with chronic and long term conditions.
The new home health clarifying regulations are much better than initially proposed. The final regulations should be helpful to advocates in their efforts to ensure that necessary Medicare-covered home health services are initiated and continued. The Center for Medicare Advocacy and other beneficiary advocates and organizations were very involved in efforts to obtain these clarifications. We are grateful to CMS for the important edits that were made to the final regulations.
75 Fed. Reg. 70461 (Nov. 17, 2010), amending 42 C.F. R. §409.44(c), effective January 1, 2011
 42 CFR §409.44(c)(2)(iii)(C); 75 FR 70395 (Nov. 17, 2010)
 75 CFR 70395 (Nov. 17, 2010)
 75 Fed. Reg. 70394
 75 Fed. Reg. 70393
 75 Fed. Reg. 70394
 75 Fed. Reg. 70395