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Statement of Need: This rule proposes to completely revise and reorganize the existing Conditions of Participation (CoPs) for Medicare participating hospice providers published in 1983. The proposed rule is a regulatory reform initiative that would revise the existing CoPs that hospices must meet to participate in the Medicare and Medicaid programs. The proposed requirements focus on the care delivered to patients and patients’ families by hospices and the outcomes of that care. The proposed requirements continue to reflect an interdisciplinary view of patient care and allow hospices flexibility in meeting quality standards. These changes are an integral part of the Administration's efforts to achieve broad-based improvements in the quality of health care furnished through the Medicare and Medicaid programs. This proposed rule codifies hospice requirements in the Balanced Budget Act of 1997 and the Medicare Modernization Act of 2003, sections 408 and 946.

Summary of the Legal Basis: Section 1861(dd) of the Social Security Act (the Act) provides the statutory qualifications and requirements that a hospice must meet to receive payment for hospice care given to Medicare beneficiaries who elect the hospice benefit under the Medicare and Medicaid programs. This section gives the Secretary broad authority to establish standards for hospices. Under this authority, the Secretary established CoPs for hospices at 42 CFR 418, et seq. In addition, section 1102 of the Act gives the Secretary the authority to make and publish such rules and regulations as may be necessary to the efficient administration of the functions with which he is charged under the Act. This section of the Act gives the Secretary broad authority to establish requirements for hospices that are necessary for the efficient administration of the Medicare program.

Alternatives: Rely on the current CoPs: This is not a reasonable option because the current CoPs are not patient-focused but rather problem-focused, an approach that has inherent limits. Trying to ensure quality through the enforcement of prescriptive health and safety standards, rather than trying to improve quality of care for all patients, adversely affects agency improvement efforts and does not stimulate broad-based quality of care initiatives. On the other hand, revising the current CoPs would take advantage of continuing advances in health care delivery. Increase prescriptive requirements relative to patient rights, drugs and durable medical equipment, and personnel qualifications. CMS decided not to pursue this approach because the additional burden that would be placed on hospices would outweigh any potential benefits. Exclude the revisions to the comprehensive assessment and interdisciplinary group requirements: Since these areas represent two of the most frequently cited deficiencies noted during hospice surveys and have a great impact on patient care, CMS decided that these sections did, in fact, need to be strengthened.

Anticipated Costs and Benefits: While we anticipate a minimal annual cost per hospice to comply with the requirements in this rule, we expect a positive reaction from all affected entities including beneficiaries, associations, and providers. This rule is highly anticipated by the hospice industry since the standards have not been updated since 1990.

Risks: Overall, this rule is a "good news rule" for which we expect a positive reaction from all affected entities including beneficiaries, associations, providers, and Congress. Beneficiaries--we expect that beneficiaries will be pleased with the strong focus on patient’s rights, patient education, and patient safety throughout the proposed rule. Associations--the National Hospice and Palliative Care Organization and the National Association for Home Care have been requesting the promulgation of new regulations for several years and has actively worked with us in sharing information. Hospice providers--hospices may have mixed feelings about the proposed regulations. We are proposing to bring the regulations in line with current standards of practice and are proposing to substantially decrease provider burden in many areas of the proposed rule such as in nurse staffing and dietary counseling. However, we are also proposing to increase the focus on patient assessment, quality assessment, and performance improvement that may require an additional level of effort. We believe that the patient safety and quality care benefits should outweigh these concerns. In response to requests from hospice and nursing facility associations, we have clarified the relationship between hospices and nursing facilities through a proposed new condition. Nurse practitioners (NPs)--we are proposing to allow NPs to see, treat, and write orders for patients, as defined by the plan of care. Congress--we do not expect that these proposed regulations would be opposed in their overall approach to patient care.