RULES AND REGULATIONS

RULES AND REGULATIONS

FOR THE WYOMING COLORECTAL CANCER EARLY DETECTION PROGRAM

CHAPTER 15

GENERAL PROVISIONS

Section 1. Statutory Authority. This chapter is promulgated by the Wyoming Department of Health pursuant to various provisions of the 2007 General Session, Senate Enrolled Act (SEA) 92, to be codified as W.S. 35-25-204, which authorizes the Department to establish the Wyoming Colorectal Cancer Early Detection Program (WCCEDP).

Section 2. Purpose and Applicability.

(a) To provide the WCCEDP the authority to issue vouchers for colonoscopies to eligible Wyoming residents who are at or below 250% of the Federal Poverty Level.

Section 3. General Provisions.

(a) These rules shall provide for the following:

(i) Case management services to Wyoming men and women enrolled in the WCCEDP;

(ii) Collection of data pertaining to the colonoscopies performed through the WCCEDP; and

(iii) Public education and clinical outreach to educate Wyoming men, women, and providers about colorectal cancer and evidence-based screening guidelines, as well as promote the WCCEDP.

(b) The WCCEDP may issue manuals, brochures, or other documents to interpret the provisions of these rules and regulations. Such documents shall be consistent with and reflect the policies contained in these rules and regulations. The provisions contained in manuals and brochures shall be subordinate to the provisions of these rules and regulations, except as otherwise provided in W.S. 35-25-204.

(c) The incorporation by reference of any external standard is intended to be the incorporation of that standard as it is in effect on the effective date of this Chapter, except as otherwise provided in W.S. 35-25-204.

Section 4. Definitions. The following definitions shall apply in the interpretation and enforcement of these rules. Where the context in which words are used in these rules indicates such is the intent, words in the singular number shall include the plural and vice versa. Throughout these rules gender pronouns are used interchangeably. The drafters have attempted to utilize each gender pronoun in equal numbers, in random distribution. Words in each gender include individuals of the other gender. For the purpose of the rules, the following shall apply:

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(a) “Adverse Event” is an injury or complication resulting from the colonoscopy procedure.

~~(b)~~ ~~“Asymptomatic” means an individual who does not currently show symptoms of the disease being discussed.~~

(c) “Colonoscopy” is an endoscopic medical procedure that uses a long, flexible, lighted tubular instrument called a colonoscope to view the rectum and the entire inner lining of the colon (large intestine).

(d) “Department” means the Wyoming Department of Health, its agent, designee, or successor.

(e) “Enrollment Start-Date” is the date the application is approved by the WCCEDP enrollment specialist.

(f) “Federal Poverty Level” means the set minimum amount of income that a family needs for food, clothing, transportation, shelter and other necessities. In the United States, this level is determined by the United States Department of Health and Human Services.

(g) “Team Member” refers to the Enrollment Specialist, Nurse Manager, or Program Manager for the Wyoming Colorectal Cancer Early Detection Program.

(h) “Wyoming Board of Medicine” is the board that serves and protects the public through licensing and disciplining physicians and physician assistants under the authority of the Medical Practice Act.

(i) “WCCEDP-approved CPT code list” refers to a code list created by the WCCEDP which identifies various colonoscopy-related codes which are reimbursable by the program. The list will be posted on the program website and accessible to all providers.

(j) “Wyoming Medical Assistance and Services Act” refers to W.S. 42-4-101 et seq.

Section 5. Severability. If any portion of these rules is found to be invalid or unenforceable, the remainder shall continue in force and full effect.

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CHAPTER 16

PROGRAM APPLICANT ELIGIBILITY

& ENROLLMENT REQUIREMENTS

Section 1. Statement of Purpose. These rules and regulations are adopted to establish eligibility and enrollment guidelines of program applicants for the WCCEDP benefits.

Section 2. Eligibility Guidelines. An applicant must meet each criteria in the following six categories to be eligible for benefits: residency, age, asymptomatic status, income, and program provider participation. Additionally, a completed and signed application must be submitted to the WCCEDP for approval. The following eligibility criteria must be met before an application may be approved for enrollment:

(a) Applicant must have been a resident of the State of Wyoming for at least one (1) year prior to making application under the program. Applicant must provide proof of residence by presenting a valid Wyoming driver's license, or an identification card issued under Title 31 of the Wyoming Statutes. Applicant shall swear to an oath of residency when completing the application for enrollment;

(b) Applicant must be age 50 or over, and not eligible for the federal Medicare program;

~~(c) Applicant must be asymptomatic (no symptoms of colorectal cancer);~~

(d) Applicant must be at or below 250% of the Federal Poverty Level (as evidenced by most previous year’s W-2 Wage and Tax Statement);

(e) Applicant must be a patient of a clinic or hospital participating in the WCCEDP; and

(f) Upon approval of application for enrollment, Applicant will be eligible for one (1) colonoscopy every ten (10) years, counting any colonoscopy completed before July 1, 2007, or before the applicant became a Wyoming resident.

Section 3. Enrollment Guidelines.

(a) Payment for Colonoscopies Performed Prior to Enrollment Approval. There will be no reimbursement to providers for colonoscopies performed prior to the date the applicant obtains WCCEDP approval. The applicant/patient assumes all responsibility for any costs relating to procedures performed prior to the Enrollment Start Date.

(b) Enrollment Period. A client who is enrolled in the WCCEDP will remain in the program until they are eligible for Medicare at age 65, or until proper insurance coverage and financial resources become available to the client. If a client does not obtain a screen within three (3) months of initial enrollment approval, he/she will be notified in writing that enrollment approval may be terminated if screening is not obtained within the next ninety (90) calendar days. If provider capacity is insufficient at the time of enrollment approval, an extension may be given at the Department’s sole discretion.

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(c) Decision-Making Process. Upon receipt of an application, it will be reviewed and approved or denied by a minimum of two WCCEDP team members. If a decision is complex and cannot be determined by the team members, the case may be referred to the Program Manager for an enrollment decision. If a decision still cannot be made, the State Health Officer may assist in making enrollment decisions.

(d) Notification to Applicants of Approval or Denial. Eligibility is not determined online or over the telephone. Applicants are informed in writing whether their application has been approved or denied. Reasons for denial will be specified in the letter.

(e) Review Process. Applicants who are denied enrollment approval may submit a written letter explaining their situation or they may request that their healthcare provider submit a written explanation. These letters shall be submitted to the Program Manager for review. A review team, including the program nurse, is formed within the Department to respond to the applicant’s letter. The Department will make every effort to respond to the applicant’s letter within ten (10) work days.

(f) Cancer Treatment. The WCCEDP does not cover costs of treatment relating to a cancer diagnosis. In the event the patient does not qualify for Medicaid, the Nurse Manager acts as a patient navigator to aid the individual in locating or identifying resources to help reduce the burden of a cancer diagnosis on the enrolled program participant.

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CHAPTER 17

PROVIDER ELIGIBILITY, SCREENING METHODS,

& REIMBURSEMENT GUIDELINES

Section 1. Statement of Purpose. The following rules and regulations are adopted to establish provider eligibility, screening methods, and reimbursement guidelines.

Section 2. Eligibility. A physician must be licensed to practice medicine in the State of Wyoming, as determined by the Wyoming Board of Medicine, to be an eligible provider to be reimbursed for colorectal cancer screening services (i.e. colonoscopy) by the WCCEDP.

Section 3. Reimbursement for Services. Pursuant to W.S. 35-25-204, the WCCEDP will reimburse providers for the costs relating to colonoscopy screening only.

(a) Services covered by the WCCEDP. Expenses that may be reimbursed by the WCCEDP at the rate paid under the Wyoming Medical Assistance and Services Act are as follows:

(i) Pre-operative consultation fee;

(ii) Colonoscopy: Flexible, proximal to splenic flexure; diagnostic with or without collection or specimens;

(iii) Colonoscopy with single or multiple cold biopsy;

(iv) Colonoscopy with directed submucosal injection(s) of any substance;

(v) Colonoscopy with control of bleeding;

(vi) Colonoscopy with ablation of tumor(s), polyp(s), or other lesion(s) not amenable to removal by hot biopsy forceps, bipolar cautery, or snare technique;

(vii) Colonoscopy with removal of tumor(s), polyp(s), or other lesion(s) by hot biopsy forceps or bipolar cautery;

(viii) Colonoscopy with removal of tumor(s), polyp(s), or other lesion(s) by snare technique;

(ix) Level IV surgical pathology, gross and microscopic examination; and

(x) Facility and anesthesiology fees as listed on the WCCEDP-approved CPT code list.

(b) Services not covered by the WCCEDP.

(i) There will be no reimbursement to providers for colonoscopies or related costs performed prior to the WCCEDP Enrollment Start-Date. The applicant/patient must have a WCCEDP payment voucher to present to the provider prior to the procedure. If applicant/patient does not have proper enrollment approval, the applicant/patient will assume responsibility for any costs relating to procedures performed prior to enrollment approval.

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(ii) Other screenings, such as Standard or Immunochemical Fecal Occult Blood Testing (FOBT), Flexible Sigmoidoscopy, Barium Enema, Stool Mutational Analysis, CT and MRI Colonography (Virtual Colonoscopy), Screening tests requested at intervals sooner than are recommended by program guidelines (unless the Department provides a written waiver to applicant pursuant to a written explanation letter by the attending physician), Medical therapy for Inflammatory Bowel Disease, or Genetic Testing are not reimbursable by the WCCEDP.

(iii) Reimbursement for Adverse Events is not covered by the WCCEDP. The program will only reimburse for procedures identified in the WCCEDP approved-CPT coding list.

(iv) The WCCEDP shall not reimburse for follow up surgery or additional care needed if an actual cancer or other condition requiring additional care is found.

Section 4. Payment Policy. Screening by the WCCEDP will be paid by the program at the Wyoming Medicaid allowable rates. For circumstances where multiple biopsy/removal techniques are used during one colonoscopy, the program will pay 100% for the allowable Medicaid reimbursement amount for the service of the highest cost, then 50% of the allowable Medicaid reimbursement amount for the second service and 25% of the allowable Medicaid reimbursement amount for the third and sequential techniques.

(a) The contractor must accept as payment in full the current Medicaid allowable charge in effect on the date of the covered service as identified on the WCCEDP CPT- code set.

(b) The Contractor is prohibited from making additional charge(s) to the client, any member of the client’s family, or other sources of supplementation for those services covered by the WCCEDP.

(c) The Contractor shall have and/or retain the express right to bill clients enrolled in WCCEDP for any services not covered by the WCCEDP.

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CHAPTER 18

PROGRAM EVALUATON & REPORTING

Section 1. Statement of Purpose. The following rules and regulations are adopted to institute a mechanism for evaluating process and clinical outcomes relating to the Wyoming Colorectal Cancer Early Detection Program (WCCEDP).

Section 2. Minimal Data Elements. Clinics/hospitals/physicians are required to collect and submit data for the defined clinical process related to the outcomes identified below. These data shall be submitted for each individual screened through the WCCEDP.

(a) Demographic Information:

(i) Patient age;

(ii) Gender; and

(iii) Family history of colon cancer.

(b) Clinical Outcomes:

(i) Screening outcome;

(ii) Screening results (normal, positive-biopsied);

(iii) Pathology results (polyp size, histology); and

(iv) Cancer characteristics (size, histology, stage and grade).

In addition, the WCCEDP will be responsible for outcome data relating to program process. The following outcomes will be reported to the Wyoming State Legislature with regard to program outcomes and successes:

(i) Outreach: number of individuals contacted by mail, telephone, social marketing campaigns, etc.;

(ii) Responses to outreach efforts;

(iii) Screening completion rates;

(iv) Number of patients provided with transportation/translation services;

(v) Quality and timeliness of care; and

(vi) Patient satisfaction with screening program.

RULES AND REGULATIONS

FOR THE WYOMING COLORECTAL CANCER EARLY DETECTION PROGRAM

CHAPTER 15

GENERAL PROVISIONS

Section 2. Purpose and Applicability.

(c) To provide the WCCEDP the authority to issue vouchers for colonoscopies to eligible Wyoming residents who are at or below 250% of the Federal Poverty Level.

Section 3. General Provisions.

(a) These rules shall provide for the following:

(i) Case management services to Wyoming men and women enrolled in the WCCEDP;

(ii) Collection of data pertaining to the colonoscopies performed through the WCCEDP; and

(iii) Public education and clinical outreach to educate Wyoming men, women, and providers about colorectal cancer and evidence-based screening guidelines, as well as promote the WCCEDP.

(d) The WCCEDP may issue manuals, brochures, or other documents to interpret the provisions of these rules and regulations. Such documents shall be consistent with and reflect the policies contained in these rules and regulations. The provisions contained in manuals and brochures shall be subordinate to the provisions of these rules and regulations, except as otherwise provided in W.S. 35-25-204.

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(k) “Adverse Event” is an injury or complication resulting from the colonoscopy procedure.

(l) “Colonoscopy” is an endoscopic medical procedure that uses a long, flexible, lighted tubular instrument called a colonoscope to view the rectum and the entire inner lining of the colon (large intestine).

(m) “Department” means the Wyoming Department of Health, its agent, designee, or successor.

(n) “Enrollment Start-Date” is the date the application is approved by the WCCEDP enrollment specialist.

(o) “Federal Poverty Level” means the set minimum amount of income that a family needs for food, clothing, transportation, shelter and other necessities. In the United States, this level is determined by the United States Department of Health and Human Services.

(p) “Team Member” refers to the Enrollment Specialist, Nurse Manager, or Program Manager for the Wyoming Colorectal Cancer Early Detection Program.

(q) “Wyoming Board of Medicine” is the board that serves and protects the public through licensing and disciplining physicians and physician assistants under the authority of the Medical Practice Act.

(r) “WCCEDP-approved CPT code list” refers to a code list created by the WCCEDP which identifies various colonoscopy-related codes which are reimbursable by the program. The list will be posted on the program website and accessible to all providers.

(s) “Wyoming Medical Assistance and Services Act” refers to W.S. 42-4-101 et seq.

Section 5. Severability. If any portion of these rules is found to be invalid or unenforceable, the remainder shall continue in force and full effect.

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CHAPTER 16

PROGRAM APPLICANT ELIGIBILITY

& ENROLLMENT REQUIREMENTS

Section 1. Statement of Purpose. These rules and regulations are adopted to establish eligibility and enrollment guidelines of program applicants for the WCCEDP benefits.

(b) Applicant must be age 50 or over, and not eligible for the federal Medicare program;

(c) Applicant must be at or below 250% of the Federal Poverty Level (as evidenced by most previous year’s W-2 Wage and Tax Statement);

(d) Applicant must be a patient of a clinic or hospital participating in the WCCEDP; and

(e) Upon approval of application for enrollment, Applicant will be eligible for one (1) colonoscopy every ten (10) years, counting any colonoscopy completed before July 1, 2007, or before the applicant became a Wyoming resident.

Section 3. Enrollment Guidelines.

(d) Payment for Colonoscopies Performed Prior to Enrollment Approval. There will be no reimbursement to providers for colonoscopies performed prior to the date the applicant obtains WCCEDP approval. The applicant/patient assumes all responsibility for any costs relating to procedures performed prior to the Enrollment Start Date.

(e) Enrollment Period. A client who is enrolled in the WCCEDP will remain in the program until they are eligible for Medicare at age 65, or until proper insurance coverage and financial resources become available to the client. If a client does not obtain a screen within three (3) months of initial enrollment approval, he/she will be notified in writing that enrollment approval may be terminated if screening is not obtained within the next ninety (90) calendar days. If provider capacity is insufficient at the time of enrollment approval, an extension may be given at the Department’s sole discretion.

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(f) Decision-Making Process. Upon receipt of an application, it will be reviewed and approved or denied by a minimum of two WCCEDP team members. If a decision is complex and cannot be determined by the team members, the case may be referred to the Program Manager for an enrollment decision. If a decision still cannot be made, the State Health Officer may assist in making enrollment decisions.

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CHAPTER 17

PROVIDER ELIGIBILITY, SCREENING METHODS,

& REIMBURSEMENT GUIDELINES

Section 1. Statement of Purpose. The following rules and regulations are adopted to establish provider eligibility, screening methods, and reimbursement guidelines.

Section 3. Reimbursement for Services. Pursuant to W.S. 35-25-204, the WCCEDP will reimburse providers for the costs relating to colonoscopy screening only.

(b) Services covered by the WCCEDP. Expenses that may be reimbursed by the WCCEDP at the rate paid under the Wyoming Medical Assistance and Services Act are as follows:

(xi) Pre-operative consultation fee;

(xii) Colonoscopy: Flexible, proximal to splenic flexure; diagnostic with or without collection or specimens;

(xiii) Colonoscopy with single or multiple cold biopsy;

(xiv) Colonoscopy with directed submucosal injection(s) of any substance;

(xv) Colonoscopy with control of bleeding;

(xvi) Colonoscopy with ablation of tumor(s), polyp(s), or other lesion(s) not amenable to removal by hot biopsy forceps, bipolar cautery, or snare technique;

(xvii) Colonoscopy with removal of tumor(s), polyp(s), or other lesion(s) by hot biopsy forceps or bipolar cautery;

(xviii) Colonoscopy with removal of tumor(s), polyp(s), or other lesion(s) by snare technique;

(xix) Level IV surgical pathology, gross and microscopic examination; and

(xx) Facility and anesthesiology fees as listed on the WCCEDP-approved CPT code list.

(b) Services not covered by the WCCEDP.

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(iii) Reimbursement for Adverse Events is not covered by the WCCEDP. The program will only reimburse for procedures identified in the WCCEDP approved-CPT coding list.

(iv) The WCCEDP shall not reimburse for follow up surgery or additional care needed if an actual cancer or other condition requiring additional care is found.

(a) The contractor must accept as payment in full the current Medicaid allowable charge in effect on the date of the covered service as identified on the WCCEDP CPT- code set.

(b) The Contractor is prohibited from making additional charge(s) to the client, any member of the client’s family, or other sources of supplementation for those services covered by the WCCEDP.

(c) The Contractor shall have and/or retain the express right to bill clients enrolled in WCCEDP for any services not covered by the WCCEDP.

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CHAPTER 18

PROGRAM EVALUATON & REPORTING

(d) Demographic Information:

(iv) Patient age;

(v) Gender; and

(vi) Family history of colon cancer.

(e) Clinical Outcomes:

(v) Screening outcome;

(vi) Screening results (normal, positive-biopsied);

(vii) Pathology results (polyp size, histology); and

(viii) Cancer characteristics (size, histology, stage and grade).

(f) Process related outcomes:

(vii) Outreach: number of individuals contacted by mail, telephone, social marketing campaigns, etc.;

(viii) Responses to outreach efforts;

(ix) Screening completion rates;

(x) Number of patients provided with transportation/translation services;

(xi) Quality and timeliness of care; and

(xii) Patient satisfaction with screening program.

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