Code of Colorado Regulations, Rule 6 CCR 1011-3, Section 4 - LICENSING | Code of Colorado Regulations

4.1 License Required

4.1.1 On or after July 1, 2018, a person, sole proprietorship, partnership, corporation, nonprofit entity, special district, governmental unit or agency, or licensed or certified health care facility that is subject to regulation under Article 1.5 or Article 3 of Title 25, C.R.S. shall not manage and offer, directly or by contract, community integrated health care services or operate or maintain a CIHCS Agency without having submitted a completed application for licensure as a Community Integrated Health Care Service Agency.

4.1.2 On or after December 31, 2018, a person, sole proprietorship, partnership, corporation, nonprofit entity, special district, governmental unit or agency, or licensed or certified health care facility that is subject to regulation under Article 1.5 or Article 3 of Title 25, C.R.S. shall not operate or maintain a CIHCS Agency without a community integrated health care services license issued by the Department.

4.1.3 A license as a Community Integrated Health Care Service Agency is not required for an entity that only provides the following services:

A) Health education and information available on relevant services; and/or

B) Referrals for and information concerning low-cost medication programs and alternative resources to the 911 system.

4.1.4 A person, including an owner or administrator of a CIHCS Agency, who violates Sections 4.1.1 and 4.1.2 of these rules shall be guilty of a misdemeanor and, upon conviction thereof:

A) Shall be punished by a fine of not less than fifty dollars nor more than five hundred dollars; and

B) May be subject, pursuant to Section 25-3.5-1302(2)(a)(II), C.R.S., to a civil penalty assessed by the Department for an amount of up to $10,000 per violation of Sections 4.1.1 and 4.1.2.

4.2 License Procedure

4.2.1 No later than July 1, 2018, an applicant as described in Section 4.1.1 of these rules that provides or intends to provide, directly or by contract, community integrated health care services must submit a completed application in the manner and form required by the Department.

4.2.2 An applicant for an initial license, or a licensee holding a Community Integrated Health Care Service Agency license, shall comply with the requirements of 6 CCR 1011-1, Chapter 2, Section 2.7 regarding the process for change of ownership.

4.2.3 When applying for an initial or renewal license, the applicant Agency shall include evidence of either general liability insurance coverage or a surety bond in lieu of general liability insurance coverage. Such coverage shall be maintained for the duration of the license period and shall include coverage for the Agency and any staff that the Agency employs or contracts with.

A) An applicant Agency that is not granted qualified immunity under Section 24-10-101, C.R.S., et seq., shall provide proof of either general liability insurance or a surety bond. The minimum amount of general liability insurance coverage or surety bond shall be as set forth in Section 24-10-114(1)(a), C.R.S.

B) An applicant Agency that is granted qualified immunity under the Colorado Governmental Immunity Act, Sections 24-10-101, C.R.S. et seq., shall provide proof of general liability insurance in an amount not less than the amount calculated in accordance with Section 24-10-114(1) (a)(1) and (1)(b), C.R.S.

4.2.4 Fingerprints

A) With the submission of an application for an Agency license, or within ten (10) calendar days after a change in the Agency owner and/or Agency administrator, each owner and administrator of an Agency applying for a license shall submit a complete set of his or her fingerprints to the Colorado Bureau of Investigation for the purpose of conducting a state and national fingerprint-based criminal history record check utilizing the records of the Colorado Bureau of Investigation and the Federal Bureau of Investigation.

B) Each owner and administrator is responsible for paying the fee established by the Colorado Bureau of Investigation for conducting the criminal history record check.

C) If an owner or administrator has twice submitted to a fingerprint-based criminal history record check to either the Federal Bureau of Investigation or the Colorado Bureau of Investigation, and the fingerprints are deemed unclassifiable, then the department may acquire a Colorado Bureau of Investigation and/or Federal Bureau of Investigation name-based criminal history report.

4.2.5 The Department may deny a license or renewal of a license if the applicant or Agency owner or administrator has been convicted of a felony or misdemeanor which involves conduct that the Department determines could pose a risk to the health, safety, or welfare of community integrated health care services consumers.

4.2.6 The Department may review and investigate each initial and renewal license application to ensure the applicant's compliance with these rules. The licensing determination shall be based on one or more of the following:

A) An on-site investigation of the Agency;

B) A review of the application and associated documents;

C) A review of the Agency's compliance history, including the results of complaint investigations and occurrence reports;

D) Interviews with consumers and/or staff;

E) A review of required Agency policies and procedures; and

F) Any other information the Department determines is necessary to make a licensing determination.

4.2.7 Except as otherwise specified in these or other applicable rules, the Department shall issue or renew a license when it is satisfied that the applicant or licensee complies with these rules. The Department may refuse to issue or renew the license of an applicant or Agency that is out of compliance with the requirements of Section 25-3.5-1301, et seq, C.R.S. or these rules.

4.2.8 A license issued or renewed pursuant to this Section 4 shall expire after one (1) year.

4.2.9 A Community Integrated Health Care Service Agency license is not transferable. The license is only valid while in the possession of the licensee to whom it is issued and shall not be subject to sale, assignment or other transfer, voluntary or involuntary, nor shall a license be valid for any purposes other than those for which it was originally issued.

4.2.10 If the Department denies an application for an initial or renewal license, the Department shall notify the applicant in writing of such denial by mailing a notice to the applicant at the address shown on the application.

4.2.11 Denial of a license may be appealed within 60 days of receipt of the written notice of denial. Requests for the Department to set a hearing must be in writing.

4.2.12 All hearings on license denials shall be conducted in accordance with the State Administrative Procedure Act, Section 24-4-101, C.R.S., et seq.

4.3 Required License Information

The applicant shall provide the following:

4.3.1 Community Needs Assessment

A) Any applicant for a Community Integrated Health Care Services Agency license shall submit the following information:

i) A description of the program, population to be served, and types of services the applicant intends to provide;

ii) A description of the geographic area that it intends to serve and a list of the contiguous counties that it plans to serve within the declared geographical area;

iii) A description of how the applicant intends to coordinate with existing resources and programs, including licensed health care facilities;

iv) A description or plan of how the applicant will identify the needs of the community that it will serve;

v) Identification of:

a) Any partners the applicant intends to work and collaborate with, if any, to achieve program goals, and the groups or organizations within the community that support the program, if any; and

b) A community's specific needs, such as communication or language barriers, social support systems, environmental concerns, transportation accessibility issues, and any other appropriate information regarding barriers to meeting a consumer's non-medical goal and/or health related outcomes within the community.

B) If the licensee modifies its community needs assessment, it shall notify the Department in writing at the time it submits its license renewal application to the Department.

C) The Department may request supplemental information for clarification of any information submitted for the community needs assessment prior to initial or ongoing licensing approval.

4.3.2 Other required information

A) Proof of general liability insurance or surety bond as specified in Section 4.2.3 of these rules;

B) Identification of the Agency's medical director(s);

C) Identification of the Agency's administrator;

D) The CIHCS Agency shall make available copies of its policies and procedures required by Section 4.2.4 of these rules;

E) Compliance with fingerprint requirements in Section 4.2.4 of these rules;

F) After January 1, 2019, compliance with the Colorado Adult Protective Services Data System (CAPS Check) requirements set forth in Section 26-3.1-111, C.R.S.;

G) The CIHCS Agency shall make available the quality management program to the Department for review during the initial licensure survey and all subsequent surveys; and

H) Any other information the Department determines is necessary to make a licensing determination.

4.3.3 In addition to the information required by Sections 4.3.1 and 4.3.2 of these rules, an applicant shall provide written notification to the Board of County Commissioners of the jurisdictions in which it plans to operate that the applicant intends to obtain a Community Integrated Health Care Service license. The applicant shall also provide a copy of the written notification to the Department.

4.3.4 The appropriate fee(s) shall accompany the initial or renewal license application.

4.4 Provisional License

4.4.1 Circumstances warranting a provisional license

A) The Department may issue a provisional license to any applicant for an initial license to operate a Community Integrated Health Care Service Agency for a period of ninety (90) days if the applicant is temporarily unable to conform to all the minimum standards required by this chapter. However, no provisional license shall be issued to an applicant if the operation of the applicant's CIHCS Agency will adversely affect the health, safety, or welfare of the CIHCS consumers.

B) The Department may issue a second provisional license for the same duration if the Department determines substantial compliance with these requirements is occurring and shall charge the same fee as for the first provisional license. If the licensee has made a timely and sufficient application for renewal of the provisional license, the existing license shall not expire until the Department has acted upon the renewal application. The Department may not issue a third or subsequent provisional license to the applicant, and in no event shall an Agency be provisionally licensed for a period to exceed one hundred eighty (180) calendar days.

C) As a condition of obtaining a provisional license, the applicant shall show proof to the Department that attempts are being made to conform and comply with applicable standards.

4.5 License Fees

All fees shall be based on the Department's direct and indirect cost of implementing the program. Any entity, including an Agency wholly owned and operated by a governmental unit or agency, which applies to operate a CIHCS Agency shall pay the applicable fees.

Initial Licensure Fee	$3000
Renewal Licensure Fee	$1700
Provisional Licensure Fee	$750
Change Of Ownership Fee	$3000
Change Of Name And Change Of Address Fee	$75
Revisit Fee	$1700
Late Fee	$1700

4.6 Inspections

4.6.1 The Department may conduct an inspection or re-inspection of the Agency and all aspects of its operations, including policies and procedures, equipment, consumer records, staffing records, and other documentation, at any time it deems necessary to ensure compliance with these rules and to protect the health, safety and welfare of the Agency's consumers. Additionally, the Department may conduct complaint and other investigations as needed.

4.6.2 Inspections may include evaluation of care and services at the consumer's home with the consumer's consent.

4.6.3 The CIHCS Agency shall retain its consumer records in accordance with state and federal requirements, but for no less than four (4) years, and those records shall be readily available to the Department during inspection and/or investigation. The Department will keep medical records and personally identifying health information obtained during an inspection confidential, and those records are exempt from disclosure.

4.6.4 Consumer records kept in the home or individual consumer documents not included in the CIHCS Agency permanent record shall be made available to the Department within two hours of request if the visit occurred 14 or more days prior to the request. The time for production may be extended at the Department's discretion.

4.6.5 The consumer file and administrative records, including, but not limited to, census and demographic information, complaint and incident reports, meeting minutes, quality management and annual program review documents , shall be provided to the Department commencing within 30 minutes of request. The time for production may be extended at the Department's discretion.

4.7 Plan of Correction

4.7.1 After any Department inspection or complaint investigation, the Department may request a plan of correction from a CIHCS Agency. A plan of correction shall be in the format prescribed by the Department and shall address, at minimum, the following:

A) Corrective action that will be accomplished for those consumers who have been affected by the deficient practice;

B) Identification of other consumers having the potential to be affected by the same deficient practice and the corrective action implemented;

C) Root cause(s) that led to the deficient practice and any measures and systematic changes the Agency will implement to ensure the deficient practice will not recur;

D) Monitoring procedure to ensure that the plan of correction is effective and that the specific deficiency(ies) cited remains corrected and/or in compliance with the regulatory requirements; and

E) Overall date when corrective action will be completed.

4.7.2 Completed plans of correction shall be:

A) Submitted within ten (10) calendar days after the date of the Department's mailing of the written notice of deficiencies to the Agency, unless otherwise required or approved by the Department; and

B) Signed by the Agency administrator.

4.7.3 The Department has the discretion to approve, modify or reject plans of correction.

A) If the plan of correction is accepted, the Department shall notify the Agency by issuing a written notice of acceptance within thirty (30) calendar days of receipt of the plan.

B) If the plan of correction is unacceptable, the Department shall notify the Agency in writing, and the Agency shall submit a revised plan of correction to the Department within fifteen (15) calendar days of the date of the written notice.

C) If the Agency fails to comply with the requirements or deadlines for submission of a plan or fails to submit a revised plan of correction, the Department may reject the plan of correction and impose intermediate restrictions or conditions as set forth in Section 4.8 of these rules.

D) If the Agency fails to timely implement the actions agreed to in the plan of correction, the Department may impose intermediate restrictions or conditions as set forth in Section 4.8 of these rules.

4.8 Intermediate Restrictions or Conditions

4.8.1 The Department may impose intermediate restrictions or conditions on an Agency for violation of these rules that may include at least one of the following:

A) Retaining a consultant to address corrective measures;

B) Monitoring by the Department for a specific period;

C) Providing additional training to employees, owners, or administrators of the Agency;

D) Complying with a directed written plan to correct the violation; or

E) Paying a civil penalty of up to $10,000 per violation.

4.8.2 If the Department imposes an intermediate restriction or condition that is not the result of a serious and immediate threat to health or welfare, the Department shall provide the Agency with written notice of the restriction or condition. No later than ten (10) calendar days after receipt of the notice, the Agency shall submit a written plan to the Department setting forth the time frame in which it will complete the directed plan of correction.

4.8.3 If the Department imposes an intermediate restriction or condition that is the result of a serious and immediate threat to health, safety or welfare, the Department shall notify the Agency in writing, by telephone, or in person during an on-site visit.

A) The Agency shall remedy the circumstances creating the harm or potential harm immediately upon receiving notice of the restriction or condition.

B) If the Department provides notice of a restriction or condition by telephone or in person, the Department shall send written confirmation of the restriction or condition to the Agency within two (2) business days.

C) If the Department imposes an intermediate restriction or condition that requires payment of a civil penalty, the Agency may request and the Department shall grant a stay in payment of the penalty until final disposition of the restriction or condition. Additionally, the Department shall provide the Agency with an opportunity for a hearing in accordance with Section 24-4-105, C.R.S. on any civil penalty assessed.

4.9 Revocation or Suspension of License or Refusal to Renew License

4.9.1 The Department may revoke, suspend or refuse to renew the license of a Community Integrated Health Care Service Agency that is out of compliance with the requirements of Section 25-3.5-1301 et seq., C.R.S., other applicable laws, or these rules.

4.9.2 Revocation or suspension of an existing license or refusal to renew a license shall be conducted in accordance with the State Administrative Procedure Act, Section 24-4-101, et seq., C.R.S.

4.10 Summary Suspension

4.10.1 The Department may summarily suspend an Agency's license if it finds, after full investigation, that the Agency has engaged in deliberate and willful violation of Section 25-3.5-1301, et seq., C.R.S., other applicable laws, or these rules, or that the public health, safety, or welfare immediately requires emergency action.

4.10.2 If the Department summarily suspends an Agency's license, it shall provide the Agency with notice explaining the basis for the summary suspension. Additionally, the notice shall inform the Agency of its right to appeal the action and that it is entitled to a prompt hearing concerning the revocation or suspension of the Agency license.

4.10.3 Appeals of a summary suspension shall be conducted in accordance with the State Administrative Procedure Act, Section 24-4-101, et seq., C.R.S.

4.11 Annual Reporting to the Department

4.11.1 Within forty-five (45) days after an Agency's annual license expiration, the Agency shall submit, in the format determined by the Department, the following information:

A) The number of persons served by the CIHCS Agency for the annual reporting period;

B) The types of CIHCS services provided;

C) The types of providers utilized by the Agency, including whether the CIHCS providers hold any licenses, registrations, or certifications;

D) The number of visits performed by each CIHCS provider type;

E) The number of consumers who received community integrated health care services from a single visit;

F) The number of consumers who received community integrated health care services from recurrent visits;

G) An evaluation and determination of whether the Agency meets the needs it identified in its community needs assessment;

H) A measurement of any reduction in visits to an emergency department for nonemergency, non-urgent medical assistance by persons served by the CIHCS Agency; and

I) The results of any Agency performance reviews received from consumers and collaborative partners.

Code of Colorado Regulations1000 - Department of Public Health and Environment1011 - Health Facilities and Emergency Medical Services Division (1011, 1015 Series)6 CCR 1011-3 - STANDARDS FOR COMMUNITY INTEGRATED HEALTH CARE SERVICE AGENCIESSection 4 - LICENSING

Code of Colorado Regulations
1000 - Department of Public Health and Environment
1011 - Health Facilities and Emergency Medical Services Division (1011, 1015 Series)
6 CCR 1011-3 - STANDARDS FOR COMMUNITY INTEGRATED HEALTH CARE SERVICE AGENCIES
Section 4 - LICENSING