PURPOSE: This rule defines the state activities related to the inspection, complaint investigation, and issuance of the certificate for state-certified hospice programs.

1. (1) Initial Certification. After (the effective date of this rule), those hospice programs that are currently Medicare-certified hospice programs and submit an application (MO 580- 2071) shall be issued a state hospice certificate for a period not to exceed twelve (12) months. No certificate to serve the entire state shall be issued. The amount of the certification fee shall correspond at a prorated amount to the number of months for which the certificate is issued. The issuance of these initial certificates shall take into consideration the need to distribute the dates for the annual survey over a twelve (12)-month period. At the expiration of the initial certificate, an annual survey inspection shall be conducted for continued state certification.

2. (2) The Annual Survey Inspection. The hospice management shall allow representatives of the Department of Health to survey the hospice to determine continued eligibility for hospice state certification. A renewal application must be submitted by every hospice prior to the expiration of the previous certificate.

   1. (A) The survey may include visits to the place of residence of any appropriate patient or family. After completion of the Department of Health (DOH) survey, a written survey shall be prepared reporting the findings with respect to compliance or noncompliance with the provisions and the standards established in this chapter as well as a list of deficiencies found. A copy of the report and the list of deficiencies found shall be served upon the hospice within fifteen (15) business days following the survey process. The list of deficiencies shall specifically state the statute or rule which the hospice is alleged to have violated. The hospice shall inform the Department of Health of the time necessary for compliance not to exceed sixty (60) days from date of survey and within ten (10) business days shall file a plan of correction with the Department of Health. A follow-up by the Department of Health to assure implementation of the plan of correction shall occur within sixty (60) days of the hospice’s prior approved plan of correction date.
   2. (B) In addition to the survey inspection required for certification or certification renewal, the Department of Health may make other survey inspections during normal business hours. Each hospice shall allow the DOH or its authorized representatives to enter upon its premises as needed for the purpose of conducting the survey inspection.
   3. (C) Any person wishing to make a complaint against a hospice certified under the provisions of sections 197.250–197.280, RSMo may register the complaint in writing or verbally with the DOH setting forth the details and facts supporting the complaint. Any complaint related to abuse, neglect or exploitation as described in section 197.266, RSMo shall be reported according to the requirements of that section.
3. (3) Initial Application. When an initial application and fee for state hospice certification is received, the applicant shall provide the DOH with sufficient evidence that the hospice has established appropriate policies and procedures for providing hospice services according to these rules. After review of these policies and procedures, and verification that the hospice has the capability of providing hospice services by qualified persons, the DOH shall issue a temporary operating permit not to exceed ninety (90) days. After the hospice has been in operation for ninety (90) days, or sooner if possible, the DOH shall survey the hospice for compliance with these rules. The hospice shall have provided care to at least three (3) patients for a period of at least three (3) weeks for the purpose of the initial survey review. The DOH shall conduct the unannounced initial review after the applicant indicates a readiness for that survey. The DOH may extend the temporary approved certificate if the hospice can show good intent to accomplish the preparations for initial survey.

4. (4) Change of Ownership. The hospice certification shall not be transferable or assignable. If during the period in which a certificate is in effect, an operator which is a partnership, limited partnership, or corporation undergoes any of the following changes, whether by one (1) or by more than one (1) action, the operator shall apply for a new approved certificate not less than thirty (30) days before any change:

   1. (A) With respect to a limited partnership, a change in the majority interest of general partners;
   2. (B) With respect to a limited partnership, a change in the general partner or in the majority interest of limited partners; or
   3. (C) With respect to a for-profit corporation, a change in the persons who own, hold or have the power to vote the majority of any class of stocks issued by the corporation.
5. (5) Multiple Offices/Counties. When the hospice consistently manages and supervises multiple offices, serving contiguous geographic areas as evidenced by indicators such as consistent meetings, chart review and other methods, and evidences the provision of patient care services on a consistent basis throughout its geographic area of services, only one (1) certificate shall be required. When the hospice has multiple offices or county areas and it is evident that consistent management and supervision or consistent provision of patient care services throughout its service area is lacking, a separate certificate shall be required for one (1) or more of the multiple offices or through the new development of a separate certified office as determined by the DOH. State wide certification will not be granted. Inpatient facilities shall be located within boundaries of the state of Missouri.
6. (6) Satellite Offices and Reciprocal Agreements with Bordering States. All agencies providing hospice services in Missouri shall have a valid Missouri Hospice Certification and shall pay the annual fee. The DOH shall not be required to survey a hospice providing service to Missouri residents through an office located in a state bordering Missouri if the area served in Missouri by the agency is contiguous to the area served in the bordering state and the state in which the agency is located has a reciprocal agreement with Missouri on Hospice Certification. If the agency is in a state which does not have a reciprocal agreement with Missouri on Hospice Certification, that agency shall maintain a satellite office in Missouri. The satellite office shall make available all records required for the survey which shall be conducted by the DOH.
7. (7) Certificate Not Issued. A certificate shall not be issued or renewed if the operator, owner or any principle in the operation of the hospice has ever been convicted of any offense concerning the operation of hospice or of any offense which is reasonably related to the qualification, functions, or duties of a hospice. Notwithstanding any other provisions of law, the DOH shall have access to records involving an owner or manager of a hospice applying for or renewing a certificate as provided in this chapter, where the applicant has been adjudicated and found guilty or entered a plea of guilty or nolo contendere in a prosecution under the laws of any state or of the United States for any offense reasonably related to the qualification, functions or duties of any person who manages or owns a hospice certified under sections 197.2500– 197.280, RSMo. The DOH may deny, suspend, or revoke the certificate of any company whose owners or managers have been convicted of such an offense.
8. (8) Revocation. The DOH may refuse to issue, may suspend or may revoke or refuse to renew the certificate of any hospice for failure to comply with any provision of sections 197.250–197.280, RSMo, or with any of these rules or standards adopted under the provisions of sections 197.250–197.280, RSMo, or for obtaining a certificate by means of fraud, misrepresentation or concealment of any material facts. Any hospice which has been refused a certificate or which has had its certificate revoked or suspended by the DOH may seek a review of the Department of Health’s action by the Administrative Hearing Commission. There shall be a six (6)-month waiting period for reapplication from final Department of Health action.

9. (9) Intermediate Sanctions. If the department determines on the basis of an inspection, or otherwise, that a state-certified hospice program is no longer in compliance with the requirements specified in these rules, and determines that the deficiencies jeopardize the health and safety of the patients of the hospice, the department shall take action to remedy the specific deficiencies through intermediate sanctions or the termination of the certification. Any action taken under this section shall be immediately effective notwithstanding any provisions of law to the contrary. Intermediate sanctions may include:

   1. (A) Suspension of all or part of the services provided by the hospice;
   2. (B) Restrictions on the admission of new patients to the hospice’s program;
   3. (C) DOH approval of the appointment of temporary management at hospice expense to oversee the operation of the hospice to protect and assure the health and safety of the individuals under the care of the hospice while improvements are made in order to bring the hospice into compliance with the requirements of these rules; and
   4. (D) These intermediate sanctions shall be designed so as to minimize the time between 19 CSR 30-35

identification of deficiencies and imposition of these sanctions, and shall provide for the imposition of incrementally more severe sanctions for repeated or uncorrected deficiencies.

1. (10) This rule will expire October 15, 2001.

AUTHORITY: section 197.250, RSMo 1994.* Original rule filed March 8, 1996, effective Oct. 30, 1996. *Original authority 1992.