10 CCR 2505-10
DEPARTMENT OF HEALTH CARE POLICY AND FINANCING MEDICAL ASSISTANCE - SECTION 8.600 10 CCR 2505-10 8.600 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________
8.607.2 DETERMINATION OF DEVELOPMENTAL DISABILITY
A. Any person, his/her legal guardian, parent(s) of a minor or such person(s) authorized by law may submit a written request for a determination of whether the applicant has a developmental disability.
B. A determination of developmental disability does not constitute a determination of eligibility for services or supports. The Community Centered Boards shall determine whether a person has a developmental disability and therefore may be eligible to receive services and supports pursuant to Sections 25.5-10-202(2) and 211, C.R.S., in accordance with criteria as specified by the Department.
Eligibility for Medicaid funded programs specific to persons with developmental disabilities shall be determined pursuant to the Colorado Department of Health Care Policy and Financing's Medical Assistance rules (10 C.C.R. 2505-10).
C. The developmental disability determination shall be made according to Department procedures, which shall identify the qualifications of person(s) making such a determination.
D. A request for determination of developmental disability shall be submitted to the Community Centered Board in the designated service area where the person resides, including temporary residence such as incarceration or hospitalization.
E. At the time of request, the Community Centered Board shall:
1. Provide the applicant any required forms and a list of the minimum required documents and information necessary for the determination of developmental disability; and, 2. Provide the applicant with information on where to obtain testing for the level of intellectual functioning and adaptive behavior, if requested. The responsibility for obtaining such assessments shall be with the applicant and/or legal guardian.
F. The applicant and/or legal guardian shall provide all documentation and information necessary for the determination of developmental disability within ninety (90) calendar days of the request.
1. The Community Centered Board may request additional documentation and/or information, as needed, to complete the determination of developmental disability.
2. The applicant and/or legal guardian may have additional assessments completed and submitted to the Community Centered Board for consideration.
G. If the applicant and/or legal guardian has not provided the documentation and information necessary for the determination within ninety (90) calendar days of the request, the Community Centered Board shall:
1. Close the request and notify the applicant in writing according to the procedures established at Section 8.607.2.L.4; or, 2. The Community Centered Board may, at the request of the applicant and/or legal guardian, extend the deadline for providing the necessary documentation and information by up to an additional ninety (90) calendar days.
H. For all applicants, the Community Centered Board shall enter into the Department's designated data system and shall permanently maintain a written and/or electronic record of the developmental disability determination on a Department prescribed form. The record, at a minimum, shall include:
1. The name of the applicant;
2. The applicant's date of birth;
3. The date of the determination of developmental disability;
4. A description of the rationale for the developmental disability determination including, at minimum, assessment scores and diagnoses;
5. The name(s) and title(s) of the person(s) involved in making the determination.
I. All information and assessments used to determine a developmental disability shall be current so as to accurately represent the applicant's abilities at the time of determination.
1. Assessments of adaptive behavior shall have been completed within three (3) years of the request.
2. Assessments of intellectual functioning shall have been completed as follows:
3. An established neurological condition shall be documented as follows:
4. The effects of mental illness or physical or sensory impairment must be considered to determine the extent to which such impairments are the sole contributing factor to the impairment of general intellectual functioning or limitations to adaptive behavior.
J. Prior to July 1, 2015, the Community Centered Board shall make the determination of developmental disability within ninety (90) calendar days of the receipt of all necessary information. On or after July 1, 2015, the Community Centered Board shall make the determination of developmental disability within thirty (30) calendar days of the receipt of all necessary information.
K. The date of the developmental disability determination shall be the date that the Department prescribed form and all documentation and information necessary for the determination of developmental disability was received by the Community Centered Board. If a delay to the determination of developmental disability is due to the actions or inactions of the Community Centered Board, the original date of request shall be used.
L. The Community Centered Board making the developmental disability determination shall, in writing, notify the applicant or legal guardian, and the authorized person requesting the determination, if other than the applicant or legal guardian, and other such persons as designated by the applicant, of the decision. Such notification shall:
1. Be mailed to the person within seven (7) calendar days of the date of determination;
2. Be provided in such alternative means of communication as to reasonably ensure that the information has been communicated in an understandable form; and, 3. For persons determined to have a developmental disability, contain an explanation of the process that will occur and notice that, at a minimum, an Individualized Plan shall be developed upon enrollment into a developmental disability service;
4. For persons determined not to have a developmental disability or persons whose request is closed without the determination of a developmental disability, state the reasons for the determination or closure, and provide a written For persons determined not to have a developmental disability or persons whose request is closed without the determination of a developmental disability, state the reasons for the determination or closure, and provide a written Long-Term Care Notice of Action form in accordance with the provisions of Section 8.057 regarding the applicant's right to appeal the decision to the Office of Administrative Courts.
M. Applicants determined not to have a developmental disability may request a new determination of developmental disability at any time upon receipt of new or missing required information, and a new request date shall be established.
N. A determination of developmental disability shall be accepted by other Community Centered Boards, service agencies and regional centers.
O. A determination of developmental disability shall be permanent and shall not require renewal or review unless:
1. The interdisciplinary team determines that developmental disability services are no longer needed due to improvement in a person's condition and recommends a redetermination; or, 2. Information from a new evaluation becomes available which demonstrates sufficient improvement in a person's condition such that the determination should be reviewed.
8.608.7 RESEARCH
A. Any experimental research performed by or under the supervision of the community centered board, service agency or regional center shall be governed by policies/procedures which shall:
1. Require adherence to ethical and design standards in the conduct of research;
2. Require review by the Human Rights Committee;
3. Address the adequacy of the research design;
4. Address the qualifications of the individuals responsible for coordinating the project;
5. Address the benefits of the research in general;
6. Address the benefits and risks to the participants;
7. Address the benefits to the agency;
8. Address the possible disruptive effects of the project on agency operations;
9. Require obtaining informed consent from participants, their guardians or the parents of a minor. Such consent may be given only after consultation with:
10. Require procedures for dealing with any potentially harmful effects that may occur in the course of the research activities.
B. No person shall be subjected to experimental research or hazardous treatment procedures if the person implicitly or expressly objects to such procedures or such procedures are prohibited.
8.612 SUPPORTS INTENSITY SCALE ASSESSMENT AND SUPPORT LEVELS
8.612.1 Supports Intensity Scale (SIS) Assessment [Eff. 2/1/12]
A. Completion of a Supports Intensity Scale (SIS) Assessment is a requirement for a Member to participate in the Home and Community Based Services-Supported Living Services (HCBS-SLS) or the Home and Community Based Services for Persons with Developmental Disabilities (HCBS- DD) waiver. A Member, their legal guardian, or their legally authorized representative refusing to have a SIS assessment shall not be enrolled in the HCBS-SLS or HCBS-DD waivers.
B. Specific scores from the Member's SIS assessment shall be used in addition to Risk Factor scores to obtain the Member's Support Level in the HCBS-DD and HCBS-SLS waivers.
C. The Case Management Agency (CMA) shall conduct a SIS assessment for a Member at the time of enrollment. Reassessments shall be conducted upon approval by the Department.
D. The CMA shall:
1. Notify the Member, their legal guardian, or their legally authorized representative of the requirement for and the right to participate in the SIS assessment.
2. Support and encourage the Member to participate in the SIS assessment. If the Member chooses not to participate in the SIS assessment, the CMA shall document their choice in the Member record on the Department required data system.
3. Schedule a SIS Interviewer to conduct the assessment. If the Member, their legal guardian, or their legally authorized representative objects to the assigned SIS Interviewer, they shall be offered a choice of a different SIS Interviewer.
4. Assist the Member or other interdisciplinary team (IDT) members to identify at least two people who know the Member well enough to act as respondents for the SIS assessment. If at least two respondents cannot be identified, the CMA shall document the efforts to find two respondents and the reasons this could not be done and proceed with the assessment using the information available.
5. To facilitate person centered practices, the SIS assessment may be completed by the SIS Interviewer at an alternate location, via the telephone or using virtual technology methods. When practicable the Member’s preference of engagement shall be accommodated.
E. A qualified SIS Interviewer shall conduct the assessment. A SIS Interviewer shall not act as the respondent for a SIS assessment.
F. The CMA shall inform the Member, their legal guardian, or their legally authorized representative of the purpose of the SIS, the SIS Complaint Process, and the Support Level Review Process. The CMA shall document that this information was provided and received on the SIS and Support Level disclosure form. The CMA shall inform the Member that they will receive a copy of the completed SIS assessment within 30 days of the SIS interview date. The CMA shall document provision of a copy of the SIS assessment to the Member, their guardian, or their legally authorized representative in the Department prescribed system.
1. The CMA case manager will provide an overview of the results of the most recent SIS assessment during the initial or continued stay review (CSR) person-centered support planning process. This overview shall include discussion of:
2. If, upon review of the results of the SIS assessment at the initial or CSR planning meeting, there is a significant change in the Member’s condition or circumstances, they should refer to G. below for the SIS reassessment process or Section 8.612.4 Support Level Review Process G. After the initial SIS assessment has been completed, the CMA shall conduct a SIS reassessment for the Member only when approved by the Department through the following process:
1. Prior to a SIS reassessment being conducted, the CMA shall submit a request to the Department for approval in the format prescribed by the Department.
2. The Department shall provide the CMA with a written decision regarding the request to conduct a SIS reassessment within fifteen (15) business days after the date the request was received.
3. Upon receiving approval to conduct a SIS reassessment, the CMA shall coordinate with a SIS Interviewer to complete the SIS reassessment.
4. If the Member, their legal guardian, or their legally authorized representative disagrees with a decision to deny the SIS reassessment request, then a request for review of the decision may be submitted to the Executive Director of the Department, or their designee, within fifteen (15) business days after the date the decision was received.
5. The Department’s Executive Director, or their designee, shall review the request for conducting a SIS reassessment and provide a written decision within fifteen (15) business days of the receipt of the request for the Executive Director review.
6. The decision of the Department’s Executive Director, or their designee, shall constitute the final agency decision and will be subject to judicial review pursuant to Section 24-4- 106, C.R.S.
H. A SIS reassessment shall be conducted only when approved by the Department and when:
1. There has been a change in the Member's life circumstances or condition resulting in a significant change to the amount of services and supports needed to keep the Member safe;
2. The Member, their legal guardian, or their legally authorized representative, family member or case manager, as appropriate, has reason to believe the results of the most recent SIS assessment do not accurately reflect the Member’s current support needs; or, 3. The Member, their legal guardian, or their legally authorized representative file a complaint, as outlined in 8.612.2, regarding the administration of the SIS assessment.
I. Administration of the SIS assessments shall be reviewed by the Department for the purpose of quality assurance.
J. When the Department identifies SIS Interviewer practices that result in inaccurate SIS assessments:
1. Remediation efforts by the Department may occur to ensure that the SIS Interviewer performs assessments according to Department standards. The SIS Interviewer(s) who conducted the inaccurate SIS assessment(s) may be deemed no longer qualified to conduct SIS assessments.
2. Payments made for the administration of the inaccurate SIS assessments may be recovered through a repayment agreement; by offsetting the amount owed against current and future SIS determination payments; or, by any other appropriate action within the Department’s legal authority.
3. The Member shall receive another SIS assessment conducted by a SIS Interviewer designated by the Department.
4. The Member's Support Level and Service Plan Authorization Limit will be adjusted as necessary and effective on the date determined by the Department.
8.612.2 SIS Complaint Process [Eff. 2/1/12]
A. The Member, their legal guardian, or their legally authorized representative may file a complaint regarding the administration of the SIS assessment up to thirty (30) calendar days after the SIS assessment is conducted.
B. The complaint shall be filed verbally or in writing with the Member's CMA. Additional information to support the complaint may be submitted at that time. If the complaint has been filed verbally the CMA shall document in the Member's record on the Department required data system the time, date and details surrounding the complaint.
C. When the complainant requests that another SIS assessment be completed, the CMA shall submit a request for approval to conduct another SIS assessment, pursuant to the process identified in Section 8.612.1.G.
D. The CMA shall make efforts to resolve the complaint and provide the complainant with a written response within ten (10) business days after receipt of the complaint.
E. When a resolution cannot be reached, the CMA shall inform the complainant that they may submit the complaint to the Department within thirty (30) calendar days after receipt of the CMA response.
F. The Department shall provide a written response to the complainant within fifteen (15) business days after receipt of the complaint.
8.612.3 Support Levels [Eff. 2/1/12]
A. A Member is assigned into one of six Support Levels according to their overall support needs and based upon the standardized algorithm for the HCBS-DD or HCBS-SLS waivers. The SIS-A Assessment converts subscale raw scores for each section into standard scores for each section, which are used in the algorithm for support levels.
B. The structure of the algorithm, defined at Section 8.600.4 definitions, includes the following:
1. Algorithm factors:
c Total scores from Section 1B: Exceptional Behavioral Support Needs score from the SIS assessment; and, d. Whether the Member presents as a safety risk, defined at Section 8.600.4 definitions, as follows:
2. The subgroups in the algorithm table under each Support Level reflect variations of the intensity of the Member's basic medical and behavioral support needs; no matter which subgroup a Member falls into, they are eligible for that Support Level. The subgroups cluster individuals with similar behavioral and medical support needs within each major group.
3. Following an assessment of the factors defined above, standard scores for each factor are applied to the algorithm.
4. The results of the algorithm are used to assign Members to Support Levels one through six; with a Support Level one indicating a minimal need for supports and a Support Level six indicating a significantly higher need for supports.
5. For the HCBS-SLS waiver, the Support Level determines the Service Plan Authorization Limit (SPAL), which is defined at Section 8.600.4 definitions. The SPALs are posted annually by the Department on the Department’s webpage.
6. For the HCBS-DD waiver, the Support Level determines the rate of reimbursement for the provider(s).
C. The CMA in consultation with the IDT shall make a determination whether a Member meets the definition of Public Safety Risk or Extreme Safety Risk to Self through the following process:
1. The decision shall be made by a case management supervisor. They shall:
2. The CMA shall review the status of the Member’s Safety Risk Factors at least annually or when significant changes occur, to assure that the Member continues to meet the definition(s).
D. At the point when a Member no longer meets the definition(s) of Public Safety Risk or Extreme Safety Risk to Self , their status must be changed in the Department prescribed data system which will auto-calculate the Member’s current algorithm Support Level and the Member’s Person-Centered Support Plan (PCSP) shall be updated to reflect the removal of the Risk Factor and any changes in related, identified support needs within 10 business days of the definition(s) no longer being met or, in cases where Section 8.612.3.D.1-4, applies, within 10 business days of receipt of approval or denial of the SLR request.
1. For cases in which a Member’s behavior does not satisfy a Safety Risk Factor definition but the Member’s needs continue to be substantially higher than those typical of their assigned Support Level (without adjustments for risk factors) and a Rights Modification continues to be in place, the IDT may consider a Support Level Review (SLR) request, as outlined in 10 CCR 2505-10 8.612.4, as a part of the person-centered support planning and Rights Modification process.
2. If the IDT determines a SLR request is needed, the CMA shall submit a SLR request which includes, but is not limited to, detailed information from the PCSP describing the extensive supports needed and the Rights Modification(s), to include all requirements outlined in Section 8.508.102 and Section 8.484.5.
3. The Department shall review the SLR request as outlined in 10 CCR 2505-10 8.612.4.
4. Rights shall be restored as soon as circumstances justify. a, When rights are restored prior to the end date of the SLR approval period, the CMA shall notify the Department of the change in support needs in a manner determined by the Department.
E. The CMA shall inform each Member, their legal guardian, or their legally authorized representative of their Support Level at the time of the initial or annual person-centered support planning process or when the Support Level changes for any reason.
F. Notification to the Member of a Support Level change shall occur within twenty (20) business days of the date after the Support Level change.
G. The Member shall be notified, pursuant to the Department of Health Care Policy and Financing rules in Section 8.057.2.A when a waiver service is terminated, reduced, or denied. At any time, the Member may pursue a Medicaid Fair Hearing in accordance with Section 8.057.3.A.
H. In HCBS-DD, the Department may assign a Support Level seven (7) reimbursement rate for Day Habilitation Services and Residential Habilitation Services provided to a Member with extraordinary overall needs in accordance with the Support Level Review Process. I The formula for the algorithm is:
Support Level/Subgroup Support Level 1 Subgroup 1A: ∑ 2ABE ≤ 25; 1A ≤ 1 AND 1B ≤ 2 Subgroup 1B: ∑ 2ABE ≤ 25; 1A ≤ 2 AND 1B 3-5 Subgroup 1C: ∑ 2ABE ≤ 25; 1A 3-4 AND 1B 3-5 Support Level 2 Subgroup 2A: ∑ 2ABE 26-30; 1A ≤ 1 AND 1B ≤ 2 Subgroup 2B: ∑ 2ABE 26-30; 1A ≤ 2 AND 1B 3-5 Subgroup 2C: ∑ 2ABE 26-30; 1A 3-4 AND 1B 3-5 Subgroup 1D: ∑ 2ABE ≤ 25; 1A 5-6 Subgroup 1G: ∑ 2ABE ≤ 25; 1B 6-9 Subgroup 2D: ∑ 2ABE 26-30; 1A 5-6 Subgroup 2G: ∑ 2ABE 26-30; 1B 6-9 Subgroup 3A: ∑ 2ABE 31-33; 1A ≤ 1 AND 1B ≤ 2 Subgroup 3B: ∑ 2ABE 31-33 1A ≤ 2 AND 1B 3-5 Support Level 3 Subgroup 1H: ∑ 2ABE ≤ 25; 1B 10-13 Subgroup 2H: ∑ 2ABE 26-30; 1B 10-13 Subgroup 3C: ∑ 2ABE 31-33; 1A 3-4 AND 1B 3-5 Subgroup 3D: ∑ 2ABE 31-33; 1A 3-6 Subgroup 3G: ∑ 2ABE 31-33; 1B 6-9 Subgroup 4A: ∑ 2ABE ≥ 34; 1A ≤ 1 AND 1B ≤ 2 Subgroup 4B: ∑ 2ABE ≥ 34 1A ≤ 2 AND 1B 3-5 Support Level 4 Subgroup 1E: ∑ 2ABE ≤ 25; 1A 7-8 Subgroup 1F: ∑ 2ABE ≤ 25; 1A ≥ 9 Subgroup 1I: ∑ 2ABE ≤ 25; 1B 14-15 Subgroup 1J: ∑ 2ABE ≤ 25; 1B ≥ 16 Subgroup 2E: ∑ 2ABE 26-30; 1A 7-8 Subgroup 2I: ∑ 2ABE 26-30; 1B 14-15 Subgroup 2J: ∑ 2ABE 26-30; 1B ≥ 16 Subgroup 3E: ∑ 2ABE 31-33; 1A 7-8 Subgroup 3H: ∑ 2ABE 31-33; 1B 10-13 Subgroup 4C: ∑ 2ABE ≥ 34; 1A 3-4 AND 1B 3-5 Subgroup 4G: ∑ 2ABE ≥ 34; 1B 6-9 Support Level 5 Subgroup 2F: ∑ 2ABE 26-30; 1A ≥ 9 Subgroup 3I: ∑ 2ABE 31-33; 1B 14-15 Subgroup 3J: ∑ 2ABE 31-33; 1B ≥ 16 Subgroup 4D: ∑ 2ABE ≥ 34; 1A 3-6 Subgroup 4E: ∑ 2ABE ≥ 34; 1A 7-8 Subgroup 4H: ∑ 2ABE ≥ 34; 1B 10-13 Subgroup 4I: ∑ 2ABE ≥ 34; 1B 14-15 Group 5A: Public Safety Risk (either status) AND 1b ≤ 11 Support Level 6 Subgroup 4J: ∑ 2ABE ≥ 34; 1B ≥ 16 Subgroup 3F: ∑ 2ABE 31-33; 1A ≥ 9 Subgroup 4F: ∑ 2ABE ≥ 34; 1A ≥ 9 Group 6A: Extreme Safety Risk to Self AND Public Safety Risk (either status) AND 1b ≥ 12 Group 6B: Public Safety Risk (either status) AND 1b ≥ 12 Extreme Safety Risk to Self– this factor acts to increase the level otherwise determined by the above criteria. Level 1 increases to level 3, level 2 increases to level 4, level 3 increases to level 4, level 4 increases to level 5. Subgroup 6A outlines the conditions in which level 5 may increase to level 6. Public Safety Risk– this factor acts to increase the level otherwise determined by the above criteria. Level 1 increases to level 5, level 2 increases to level 5, level 3 increases to level 5, and level 4 increases to level 6. Subgroup 6B outlines the conditions in which level 5 may increase to level 6.
8.612.4 Support Level Review Process [Eff. 2/1/12]
A. The Member, their legal guardian, or their legally authorized representative, , or CMA may request a review of the Support Level assigned when they have reason to believe it does not meet the Member's needs.
B. When a Support Level Review (SLR) is requested, the CMA shall complete the SLR request in a manner determined by the Department on the Department’s prescribed request form.. Once the SLR request form is completed, the CMA shall provide an opportunity for the Member, their legal guardian, or their legally authorized representative to review the request and provide additional information prior to submission to the Department for review.
C. The Department shall convene a review panel to examine Support Level Review requests monthly or as needed.
1. The review panel shall be comprised of the following:
2. The review panel:
3. A Member who has been assigned to a higher Support Level shall have this assignment re-examined by the review panel at least annually or at a greater or lesser frequency determined by the Department.
D. The Department shall provide the CMA and the Member, their legal guardian, or their legally authorized representative with the written decision regarding the requested review of the Member's Support Level within fifteen (15) business days after the panel meeting. The written decision notification shall include the date of the SLR request, the Support Level determination, the effective and the end date of the increased Support Level and, if denied, the reason for denial of an increased Support Level.
1. The results of the panel review for a Member enrolled in the HCBS-DD waiver are conclusive.
2. If a Member enrolled in the HCBS-SLS waiver, their legal guardian, or their legally authorized representative disagrees with the decision provided by the panel, the Member, their legal guardian, or their legally authorized representative may request a review by the Department’s Executive Director or their designee, within fifteen (15) business days after the receipt of the decision.
3. The CMA shall make any necessary PCSP and PAR revisions resulting from the Support Level changes, within 10 business days of receipt of approval or denial of the SLR request.
E. The Member shall be notified, pursuant to the Department of Health Care Policy and Financing rules in Section 8.057.2.A when a waiver service is terminated, reduced, or denied. At any time, the Member may pursue a Medicaid Fair Hearing in accordance with Section 8.057.3.A.
8.612.5 Definitions
A. “Extreme Safety Risk to Self” means a factor in addition to specific Supports Intensity Scale (SIS) scores that is considered in the calculation of a Client's support level. This factor shall be identified when a Client:
1. Displays self-destructiveness related to self-injury, suicide attempts or other similar behaviors that seriously threaten the Client's safety; and, 2. Has a rights suspension in accordance with Section 8.604.3 or has a court order that imposes line of sight supervision unless the Client is in a controlled environment that limits the ability of the Client to harm himself or herself.
B. “Member” has the same meaning as the terms “Member” and/or “Client” as defined in Sections 8.500 and 8.500.90C. “Public Safety Risk-Convicted” means a factor in addition to specific SIS scores that is considered in the calculation of a Client's support level. This factor shall be identified when a Client has:
1. Been found guilty through the criminal justice system for a criminal action involving harm to another person or arson and who continues to pose a current risk of repeating a similar serious action; and, 2. A rights suspension in accordance with Section 8.604.3 or through parole or probation, or a court order that imposes line of sight supervision unless the Client is in a controlled environment that limits his or her ability to engage in the behaviors that pose a risk or to leave the controlled environment unsupervised.
D. “Public Safety Risk-Not Convicted” means a factor in addition to specific SIS scores that is considered in the calculation of a Client's support level. This factor shall be identified when a Client has:
1. Not been found guilty through the criminal justice system, but who does pose a current and serious risk of committing actions involving harm to another person or arson; and, 2. A rights suspension in accordance with Section 8.604.3 or through parole or probation, or a court order that imposes line of sight supervision unless the Client is in a controlled environment that limits his or her ability to engage in the behaviors that pose a risk or to leave the controlled environment unsupervised.
8.660 LABORATORY AND X-RAY
8.660.1 DEFINITIONS
Independent Certified Laboratory means a certified laboratory that performs diagnostic tests and is independent both of the attending or consulting physician's office and of a hospital except where a hospital laboratory has obtained Medicare certification as an independent laboratory and is billing for recipients who are not admitted as patients in the hospital. Clinical Laboratory Services mean microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological or other examinations of fluids derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or the assessment of a medical condition.
Anatomical Laboratory Services mean examinations of tissues derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or the assessment of a medical condition.
Certified Clinical Laboratory means a provider who possesses a certificate of waiver or a certificate of registration from the Centers for Medicare and Medicaid Services or its designated agency as meeting Centers for Medicare and Medicaid Services guidelines and whose personnel and director are qualified to perform laboratory services.
X-Ray Services mean services performed by a provider whose x-ray equipment has been certified by the Colorado Department of Public Health and Environment as meeting Medicare guidelines and whose personnel and director are qualified to operate said equipment.
8.660.2 CONDITIONS OF PARTICIPATION
8.660.2. A Certified Clinical Laboratories and providers of X-Ray Services shall enroll as providers in the Medical Assistance Program.
8.660.2.B. All participating laboratories, including out-of-state independent clinical laboratories, shall be certified by the state agency to participate under Medicaid. All laboratories shall provide proof of certification status through the provision of the CLIA (Clinical Laboratory Improvement Amendments of 1988) number to the Department.
8.660.2.C. Providers of X-Ray Services shall be certified by the Colorado Department of Public Health and Environment and shall provide proof of Medicare certification on the Medicaid provider enrollment forms.
8.660.3 LIMITATIONS AND BENEFITS
8.660.3.A. Laboratory and X-Ray Services are a benefit under all of the following conditions:
1. The services have been authorized by a licensed physician.
2. The services are performed to diagnose conditions and illnesses with specific symptoms.
3. The services are performed to prevent or treat conditions that are benefits under the Medical Assistance Program.
4. The services are not routine diagnostic tests performed without apparent relationship to treatment or diagnosis for a specific illness, symptom, complaint or injury.
5. The laboratory services are performed by a certified laboratory in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
6. The X-Ray Services are performed by a provider certified by the Colorado Department of Public Health and Environment and enrolled as a Medicaid provider. 8.660.3.B. Collection, handling and/or conveyance of specimens for transfer from physicians' offices to a Certified Clinical Laboratory is reimbursable to the physician. 8.660.3.C. Transfer of a specimen from one Certified Clinical Laboratory to another is a benefit and is reimbursable to the first certified laboratory if the laboratory's equipment is not functioning or the laboratory is not certified to perform the tests ordered by the physician.
8.660.4 BILLING PROCEDURES
8.660.4.A. Certified providers of clinical laboratory and X-Ray Services shall bill the Department directly using the designated billing method, the correct Current Procedural Terminology and Healthcare Common Procedure Coding System procedure codes and modifiers as required. Providers shall bill the amount of their usual and customary charges to the general public. 8.660.4.B. Laboratory tests and x-rays performed under the personal supervision of the authorizing physician must be billed directly on the physician's services claim form. 8.660.4.C. Laboratory tests and x-rays not performed by the authorizing physician or under his/her direct personal supervision cannot be billed by the physician except for physicians in a Certified Clinical Laboratory group practice. A Certified Clinical Laboratory group practice may only bill for those laboratory and X-Ray Services actually performed or supervised by a physician member of the group or performed by a qualified employee of the group. Payment shall be made to the authorizing physician or the group practice.
8.660.4.D. Laboratory and X-Ray Services performed by a hospital-based or independent laboratory or x-ray provider and submitted to an unrelated physician for interpretation may only be billed by the laboratory or x-ray provider for the technical component. 8.660.4.E. Practitioner and clinic providers rendering professional interpretation and not direct laboratory or X-Ray Services may only bill the professional component.
8.660.5 REIMBURSEMENT
8.660.5.A. Reimbursement for certified laboratory and X-Ray Services shall be the lowest of the following:
1. Submitted charges.
2. Fee schedule as determined by the Department.
8.660.5.B. Services rendered by a hospital-based laboratory during an inpatient stay are included in the hospital Diagnosis Related Group or inpatient rate and shall not be billed or reimbursed separately.
8.660.5.C. Each certified laboratory provider shall be reimbursed for only those tests performed in the specialties or sub-specialties for which it is certified. 8.660.5.D. Reimbursement for out-of-state certified independent clinical laboratory or X-Ray Services shall be subject to Department reimbursement rates. 8.660.5.E. The reimbursement methodology at 8.660.5.A - 8.660.5.D does not apply to payments for those services/procedures that are reimbursed under a capitated or contracted agreement accomplished through competitive bid or other arrangement. _________________________________________________________________________ Editor’s Notes 10 CCR 2505-10 has been divided into smaller sections for ease of use. Versions prior to 3/4/07, Statements of Basis and Purpose, and rule history are located in the first section, 10 CCR 2505-10. Prior versions can be accessed from the History link that appears above the text in 10 CCR 2505-10. To view versions effective on or after 3/4/07, select the desired section of the rule, for example 10 CCR 2505-10 8.100, or 10 CCR 2505-10 8.500.
History [For history of this section, see Editor’s Notes in the first section, 10 CCR 2505-10]