On June 5, 2008, the Centers for Medicare & Medicaid Services (CMS) published new regulations revising the hospice conditions of participation (CoPs).  These new regulations will go into effect as of December 2, 2008.   According to CMS, the revised CoPs "focus on a patient-centered, outcome oriented, and transparent process that promotes quality patient care for every patient every time."    A summary of the new CoPs is below.  The full text can be found at:  http://edocket.access.gpo.gov/2008/pdf/08-1305.pdf.   

Patient Rights

The new regulations accord hospice patients a list of rights.  These must be explained to the hospice patient by the hospice provider during the initial assessment visit in advance of furnishing care.   The rights must be provided verbally and in writing and must be delivered in a language and manner that the patient understands.  These are the enumerated rights:

• To exercise his or her rights as a patient of the hospice;

• To have his or her property and person treated with respect;

• To voice grievances regarding treatment or care that is (or fails to be) furnished and the lack of respect for property by anyone who is furnishing services on behalf of the hospice;

• To not be subjected to discrimination or reprisal for exercising his or her rights;

• To receive effective pain management and symptom control from the hospice for conditions related to the terminal illness;

• To be involved in developing his or her hospice plan of care;

• To refuse care or treatment;

• To choose his or her attending physician;

• To have a confidential clinical record (and access to that record);

• To be free from mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of patient property;

• To receive information about the services covered under the Medicare hospice benefit; and

• To receive information about the scope of services that the hospice will provide and specific limitations on those services.

Professional Services

Hospice care uses an interdisciplinary approach to deliver medical, social, physical, emotional, and spiritual services.  The new regulations make clarifications regarding several of these services:

•  Attending Physicians
  
  Attending Physicians have frequently been encouraged to discontinue their involvement with medical care after a patient has elected hospice.  The new regulations make it clear that attending physicians can and should stay involved with their terminally ill patients' care.  According to CMS, the role of the attending physician is to provide a long term perspective on the patient and family that takes into account their medical and personal history.  Furthermore, according to CMS, it is inappropriate for a hospice to influence a patient to relinquish his or her attending physician.
   

• Coordination of Care
  
  Interdisciplinary Groups (IDGs) are composed of individuals who work together to meet the physical, medical, psychosocial, emotional and spiritual needs of hospice patients and families.  To this end, per the new regulations, hospices must designate a registered nurse to coordinate each hospice patient's care. 
   

• Pharmacy Requirements
  
  Under the new regulations, each hospice must ensure that the interdisciplinary group confers with an individual who has education and training in drug management as defined in hospice policies and procedures, and State law, to ensure that drugs and biologicals meet each patient's needs.  The individual must be an employee of, or under contract with, the hospice.  A hospice that provides inpatient care directly in its own facility must provide pharmacy services under the direction of a qualified licensed pharmacist who is also an employee of, or under contract with, the hospice.  The pharmacist's services must include evaluation of a patient's response to medication therapy, identification of potential adverse drug reactions, and recommended appropriate corrective action.
   

• Bereavement and dietary counseling
  
  Bereavement and dietary counseling get little attention in the new regulations.  Given the extensive attention given to other services, this may mean that the recognition of the importance of these services dwindles.  Per the new regulations, bereavement counseling must be furnished under the supervision of a qualified professional with experience or education in grief or loss counseling.  Dietary counseling, if identified as needed, can be done by dieticians as well as nurses and other individuals who are able to address and assure the dietary needs of the patient are met.
   

• Social Workers
  
  The new standard for training and education of hospice social workers is inappropriately low.  Previously, hospice social workers were required to have a BA in social work from a school accredited or approved by the Council on Social Work Education.  Per the new regulations, individuals can have as little as a baccalaureate degree in psychology, sociology, or other field related to social work and one year of social work experience in a healthcare setting, so long as they are supervised by an MSW.  Disturbingly, the regulations do not offer specific criteria for the MSW supervision. 

Hospice Aide and Homemaker Services

• Hospice Aides
  
  Under the old regulations, hospice aides were referred to as home health aides and their training, skill, and supervision requirements arose from those required for home health aides.   The new regulations coin the phrase "hospice aide" and outline training, skill, and supervision requirements that are specific to hospice.  The regulations specify that hospice aides are assigned to a specific patient by a registered nurse that is a member of the interdisciplinary group.  The regulation states that hospice aides are to provide services that are:

1. Ordered by the interdisciplinary group;

2. Included in the plan of care;

3. Permitted to be performed under state law by hospice aides; and

4. Consistent with hospice aide training.

The duties of the hospice aide include, but are not limited to:

1. Provision of hands-on personal care;

2. Performance of simple procedures as an extension of therapy or nursing services;

3. Assistance in ambulation or exercises; and

4. Assistance in administering medications ordinarily self-administered.

A significant cause for concern is that the new regulations state that hospice aide services are ordered by the IDG.  Note that under the home health regulations, aide services are ordered by the attending physician and historically this is how aide services were ordered for hospice care.  Having services ordered by the attending physician allows for an independent actor to determine whether aide services are reasonable and necessary.  Now that hospice aides are ordered by the hospice provider itself through its IDG rather than the attending physician, the IDG may inappropriately limit the availability of aide services to hospice patients.

• Homemaker Services
  
  Homemaker services must be provided by individuals who have successfully completed a hospice orientation addressing the needs and concerns of patients and families coping with a terminal illness.   Homemaker services must be coordinated and supervised by a member of the interdisciplinary group.  

Hospice Care and Medicaid Waiver Programs

Currently, administrators of Medicaid Waiver Programs frequently discontinue services when Medicare beneficiaries elect hospice care.  This practice should end because the new regulations state explicitly that Medicare beneficiaries who receive personal care services under a Medicaid Waiver Program may continue to receive those benefits after they have elected the Medicare hospice benefit.  Services under the Medicaid personal care benefit may be used to the extent that the hospice would routinely use the services of a hospice patient's family in implementing a patient's plan of care. The hospice must coordinate its hospice aide and homemaker services with the Medicaid personal care benefit to ensure the patient receives the hospice aide and homemaker services he or she needs.

Residents of Nursing Homes

Medicare beneficiaries who reside in nursing homes have always been able to access their hospice benefit if the hospice and facility had a contract.  The new CoPs mandate that these contracts include very specific information including:

• The manner in which the facility and the hospice are to communicate with each other and document such communications to ensure that the needs of the patient are addressed and met 24 hours a day;

• A provision stating that the hospice assumes responsibility for determining the appropriate course of hospice care, including the determination to change the level of services if needed;

• An agreement that it is the hospice's responsibility to provide services at the same level and to the same extent as those services would be provided if the resident were in his or her own home; and

• A provision that the hospice may use the facility staff where permitted by State law and as specified by the facility to assist in the administration of prescribed therapies included in the plan of care only to the extent that the hospice would routinely use the services of a hospice patient's family in implementing the plan of care. 

Rules for Hospice Inpatient Care

Hospices must provide a home-like atmosphere and ensure that patient areas are designed to preserve the dignity, comfort, and privacy of patients.  There must be physical space for private patient and family visiting, accommodations for family members to remain with the patient throughout the night; and physical space for family privacy after a patient's death.  There must be opportunity for patients to receive visitors at any hour, including infants and small children.

The patient rooms must be designed and equipped for nursing care, as well as the dignity, comfort, and privacy of patients.  The hospice must accommodate a patient and family request for a single room whenever possible.  Each patient's room must:  be at or above grade level; contain a suitable bed and other appropriate furniture for each patient; have closet space that provides security and privacy for clothing and personal belongings; accommodate no more than two patients and their family members; provide at least 80 square feet for each residing patient in a double room and at least 100 square feet for each patient residing in a single room; and be equipped with an accessible, easily-activated, functioning device with which to call for assistance.

Quality Assessment and Performance Improvement

Hospices must develop, implement, and maintain effective ongoing, hospice-wide data-driven quality assessment and performance improvement programs.  Hospices must maintain documentary evidence of their quality assessment and performance improvement programs and be able to demonstrate their operations to CMS.  The performance improvement activities must:

• Focus on high risk, high volume, or problem-prone areas;

• Consider incidence, prevalence, and severity of problems in those areas; and

• Affect palliative outcomes, patient safety, and quality of care.

Conclusion

Overall these regulations are good for Medicare beneficiaries.  They should not interfere with access and are very descriptive regarding rights and responsibilities, although advocates for hospice patients should watch to see that “hospice aides” provide appropriate hands-on care.  Further, the regulations will be meaningless without adequate survey activity and consequent enforcement.  Thus to ensure quality care to every patient every time, CMS must make a serious commitment to provider compliance.