PURPOSE: This rule describes procedures to obtain certification as a provider of residential habilitation, individualized supported living (ISL), supported employment, and day habilitation (on and off site), through the community-based Medicaid Waiver.

1. (1) Under sections 630.655, 630.010, and 376.779.3 and 4, RSMo, the department is mandated to develop certification standards and to certify an organization’s level of service, treatment or rehabilitation as necessary for the organization to operate, receive funds from the department, or participate in a service network authorized by the department and eligible for Medicaid reimbursement. However, certification in itself does not constitute an assurance or guarantee that the department will fund designated services or programs.

   1. (A) A key goal of certification is to enhance the quality of care and services with a focus on the needs and outcomes of persons served.
   2. (B) The primary function of the certification process is assessment of an organization’s compliance with standards of care. A further function is to identify and encourage developmental steps toward improved program operations, client satisfaction and positive outcomes.
   3. (C) This rule replaces sections 9 CSR 45- 5.010(4) and (5) of the Certification of Medicaid Agencies Serving Persons with Developmental Disabilities.

2. (2) An organization may request certification by completing an application form, as required by the department for this purpose, and submitting the application form, and other documentation, as may be specified, to the Department of Mental Health, PO Box 687, Jefferson City, MO 65102.

   1. (A) The organization must submit a current written description of those programs and services for which it is seeking certification by the department.
   2. (B) A new applicant shall not use a name which implies a relationship with another organization, government agency or judicial system when a formal organizational relationship does not exist.
   3. (C) Certification fees are not required.
   4. (D) The department will review a completed application within thirty (30) calendar days of receipt to determine whether the applicant organization would be appropriate for certification. The department will notify the organization of its determination.
   5. (E) An organization that wishes to apply for recertification shall submit its application forms to the department at least sixty (60) days before expiration of its existing certificate.
   6. (F) An applicant can withdraw its application at any time during the certification process, unless otherwise required by law.

3. (3) The department shall conduct a site survey at an organization to assure compliance with certification standards, standards of care and other requirements.

   1. (A) The department shall conduct a comprehensive site survey for the purpose of determining compliance with certification standards and program/service rules, except as stipulated in paragraphs (3)(B)1. through 3.
   2. (B) The department recognizes and deems as certified a provider that has attained full 9 CSR 45-5

accreditation under standards for Community Services (community living services for Individualized Supported Living (ISL) and residential habilitation and personal and social services for day habilitation) and for Employment Services (supported employment) from the Rehabilitation Accreditation Commission (CARF) or The Council on Quality and Leadership (The Council). The deemed provider must—

1. 1. Submit to the department a copy of

the most recent accreditation survey report and verification of the accreditation time period and dates within thirty (30) days of receipt from the accreditation agency.

1. 2. Notify the department when accredi-

tation surveys are scheduled or when accreditation agency makes complaint investigation visit.

1. 3. Notify the department of any changes

in accreditation status during the time period of accreditation and resurvey.

1. 4. Identify the department as a primary

stakeholder for contact by the accrediting agency during survey and resurvey data gathering processes.

1. (4) The department shall provide advance notice and scheduling of routine, planned site surveys.

   1. (A) The department shall notify the applicant and the division’s regional centers regarding survey date(s), procedures and a copy of any survey instrument that may be used. Survey procedures will include, but are not limited to, interviews with provider staff, individuals being served and other interested parties; tour and inspection of program sites; review of provider administrative records necessary to verify compliance with requirements; review of personnel records and service documentation; observation of program activities.
   2. (B) The applicant agrees, by act of submitting an application, to allow and assist department representatives in fully and freely conducting these survey procedures and to provide department representatives reasonable and immediate access to premises, individuals, and requested information.
   3. (C) An organization must engage in the certification process in good faith. The organization must provide information and documentation that is accurate, and complete. Failure to participate in good faith, including falsification or fabrication of any information used to determine compliance with requirements, may be grounds to deny issuance of or to revoke certification.
   4. (D) The surveyor(s) shall hold entrance and exit conferences with the organization to discuss survey arrangements and survey findings, respectively. If a surveyor identifies a deficiency that could result in actual jeopardy to the safety, health or welfare of persons served, the surveyor shall not leave the program until an acceptable plan of correction is presented which assures the surveyor that there is no further risk of jeopardy to persons served.

   5. (E) Within thirty (30) calendar days after the exit conference, the department shall provide a written survey report to the provider’s director and the division.

      1. 1. The report shall note all deficiencies

identified during the survey. Every instance in which the certification standards are not met will be cited as a deficiency.

1. 2. The department shall send a notice of

deficiency and the report by certified mail, return receipt requested.

1. 3. The provider shall make the report

available to the staff and to the public upon request.

1. (F) Within thirty (30) calendar days of the date that a notice of deficiency and the report is presented by certified mail to the provider, the provider shall submit to the department and regional center a plan of correction.

   1. 1. The plan must address each deficien-

cy, specifying the method of correction and the date the correction shall be completed. The provider will work with the regional center to develop a plan of correction. No correction date will exceed one hundred eighty (180) days.

1. 2. Within fifteen (15) calendar days after

receiving the plan of correction, the department shall notify the provider and the division of its decision to approve, disapprove, or require revisions of the proposed plan.

1. 3. The surveyor will assure that the plan

of correction has been implemented and deficiencies corrected. The department shall determine if it is necessary for the surveyor to make a return visit to the provider based on the criteria of the plan of correction and will notify the division and regional center(s) of revisit.

1. 4. In the event that the provider has not

submitted a plan of correction acceptable to the department within sixty (60) days of the original date that written notice of deficiencies was presented by certified mail to the provider, it shall be subject to expiration of certification.

1. (5) The department may grant certification on a temporary, provisional, conditional, or compliance status. The department will notify the division of any change in the status of a provider.

   1. (A) Temporary status shall be granted to a provider if the survey process has not been completed prior to the expiration of an existing certificate and the applicant is not at fault for failure or delay in completing the survey process.

   2. (B) Provisional status for a period of not exceeding one (1) year shall be granted to a new provider or service, a converted agency or provider, or an existing provider adding a waivered service, based on a site review which finds the program in compliance with requirements related to policy and procedure, facility, personnel, and staffing patterns sufficient to begin providing services. The regional center must notify the Licensure and Certification Office as soon as the contract is set up with the provider.

      1. 1. In the department’s initial determina-

tion and granting of provisional certification, the provider shall not be expected to fully comply with those standards which reflect ongoing program activities.

1. 2. The department shall conduct a com-

prehensive site survey of the provisionally certified provider and shall make further determination of the provider’s certification status no sooner than ninety (90) days after the provider begins serving clients nor later than the expiration date of the provisional certificate.

1. (C) Conditional status shall be granted to a provider following a site survey by the department that determines that there are pervasive and/or significant deficiencies with standards that may affect quality of care to individuals and there is reasonable expectation that the provider can achieve compliance within a stipulated time period. The department shall consider patterns and trends of performance identified during the site survey.

   1. 1. The period of conditional status shall

not exceed one hundred eighty (180) calendar days. The department may directly monitor progress, may require the provider to submit progress reports, or both.

1. 2. The department shall conduct a fur-

ther site survey within the one hundred eighty (180)-day period and make a further determination of the provider’s compliance with standards.

1. 3. During the period of conditional sta-

tus, the division may, at its discretion, take actions per sections (10) and (12) of this rule.

1. (D) Compliance status shall be awarded to a provider for a period of two (2) years following a site survey by the department that determines the provider meets all standards relating to quality of care and the safety, health, rights, and welfare of persons served. If deficiencies are cited during a site survey, any and all such deficiencies must be corand Developmental Disabilities

rected in accordance with the plan of correction prior to the department awarding compliance status.

1. (6) The department may investigate any complaint regarding the operation of a certified or deemed certified program or service. If conditions are found that are not in compliance with applicable certification standards, the department may, at its sole discretion, notify the accrediting organization of any concerns.
2. (7) The department may conduct a scheduled or unscheduled site survey of a provider at any time to monitor ongoing compliance with the certification standards. If any survey finds conditions that are not in compliance with applicable certification standards, the department may require corrective action steps and may change the provider’s certification status consistent with procedures set out in this rule.

3. (8) The department shall certify only the provider(s) named in the application. The provider(s) may not transfer certification without the written approval of the department.

   1. (A) A certificate is the property of the department and is valid only as long as the provider meets standards of care and other requirements.
   2. (B) The provider shall maintain the certificate issued by the department in a readily available location.
   3. (C) Within seven (7) calendar days of the time a certified provider organization is sold, leased, discontinued, moved to a new location, has a change in its accreditation status, appoints a new director, or changes programs or services offered, the provider shall provide written notice to the department of any such change.
   4. (D) A certified provider that establishes a new program or type of program shall operate that program in accordance with applicable standards. A provisional review, expedited site survey or comprehensive site survey shall be conducted, as determined by the department.

4. (9) The department may deny issuance of and may revoke certification based on a determination that—

   1. (A) The nature of the deficiencies results in substantial probability of or actual jeopardy to individuals being served;
   2. (B) Serious or repeated incidents of abuse or neglect of individuals being served or violations of rights have occurred;
   3. (C) Fraudulent fiscal practices have transpired or significant and repeated errors in billings to the department have occurred;
   4. (D) Failure to participate in the certification process in good faith, including falsification or fabrication of any information used to determine compliance with requirements;
   5. (E) The nature and extent of deficiencies results in the failure to conform to the certification standards of the program or service being offered; or
   6. (F) Compliance with standards has not been attained by an organization upon expiration of conditional certification.

5. (10) The department, at its discretion, may—

   1. (A) Place a monitor at a program if there is substantial probability of or actual jeopardy to the safety, health, rights, or welfare of individuals being served.

      1. 1. The cost of the monitor shall be

charged to the organization at a rate which recoups all reasonable expenses incurred by the department.

1. 2. The department shall remove the

monitor when a determination is made that the safety, health, rights, and welfare of individuals being served is no longer at risk;

1. (B) Take other action to ensure and protect the safety, health or welfare of individuals being served.

1. (11) An organization which has had certification denied or revoked may appeal to the director of the department within thirty (30) calendar days following notice of the denial or revocation being presented by certified mail to the organization. The director of the department shall conduct a hearing under procedures set out in Chapter 536, RSMo and issue findings of fact, conclusions of law and a decision which shall be final.

2. (12) The department shall have authority to impose administrative sanctions.

   1. (A) The department may suspend the certification process pending completion of an investigation when an organization that has applied for certification or the staff of that organization is under investigation for fraud, financial abuse, abuse or neglect of persons served, revocation of persons’ rights without due process, or improper clinical practices.
   2. (B) The department may administratively sanction a certified organization that has been found to have committed fraud, financial abuse, abuse of persons served, or improper clinical practices or that had reason to know its staff were engaged in such practices.
   3. (C) Administrative sanctions include, but are not limited to, suspension of certification, clinical utilization review requirements, clinical audit, suspension of new admissions, denial or revocation of certification, or other actions as determined by the department.
   4. (D) The department shall have the authority to refuse to accept for a period of up to twenty-four (24) months an application for certification from an organization that has had certification denied or revoked or that has been found to have committed fraud, financial abuse or improper clinical practices or whose staff and clinicians were engaged in improper practices.
   5. (E) An organization may appeal these sanctions pursuant to section (11).

3. (13) An organization may request the department’s exceptions committee to waive a requirement for certification if the head of the organization provides evidence that a waiver is in the best interests of the individuals it serves.

   1. (A) A request for a waiver shall be in writing and shall include justification for the request.
   2. (B) The request shall be submitted to Exceptions Committee, Department of Mental Health, PO Box 687, Jefferson City, MO 65102.
   3. (C) The exceptions committee shall hold meetings in accordance with Chapter 610, RSMo and shall respond with a written decision within forty-five (45) calendar days of receiving a request.
   4. (D) The exceptions committee may issue a waiver on a time-limited or other basis.
   5. (E) If a waiver request is denied, the exceptions committee shall give the organization forty-five (45) calendar days to fully comply with the standard, unless a different time period is specified by the committee.
4. (14) The organization must compy with other applicable requirements as set forth in 9 CSR 10-5.220 Privacy Rule of Health Insurance Portability and Accountability Act of 1996 (HIPAA).

AUTHORITY: sections 630.050 and 630.655, RSMo 2000.* 45 CFR parts 160 and 164, the Health Insurance Portability and Accountability Act of 1996. Emergency rule filed Feb. 13, 2002, effective March 1, 2002, expired Aug. 27, 2002. Original rule filed Feb. 13, 2002, effective Aug. 30, 2002. Emergency amendment filed April 1, 2003, effective April 14, 2003, expired Oct. 14, 2003. Amended: Filed April 1, 2003, effective Oct. 30, 2003. *Original authority: 630.050, RSMo 1980, amended 1993, 1995 and 630.655, RSMo 1980. 9 CSR 45-5