REIMBURSEMENT POLICY STATEMENT OHIO MEDICAIDOriginal Issue Date Next Annual Review Effective Date 1 1/01/2017 1 1/01/2018 1 1/01/2017 Policy Name Policy Number Positive Airway Pressure Devices for Pulmonary Disorders PY-0313 Policy Type Medical Administrative Pharmacy REIMBURSEMENT Reimbursement Policies prepared by CSMG Co. and its affiliates (including CareSource) are intended to provide a general reference regarding billing, coding and documentation guidelines. Coding methodology, regulatory requirements, industry-standard claims editing logic , benefits design and other factors are considered in developing Reimbursement Policies. In addition to this Policy, Reimbursement of services is subject to member benefits and eligibility on the date of service, medical necessity, adherence to plan polic ies and procedures, claims editing logic, provider contractual agreement, and applicable referral, authorization, notification and utilization management guidelines. Medically necessary services include, but are not limited to, those health care services o r supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunctio n of a body organ or par t, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any federal or state coverage mandate, Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. This Policy does not ensure an authorizati on or Reimbursement of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced herein. If there is a conflict between this Policy and the plan contract ( i.e. , Evidence of Coverage), then t he plan contract ( i.e. , Evidence of Coverage) will be the controlling document used to make the determination. CSMG Co. and its affiliates may use reasonable discretion in interpreting and applying this Policy to services provided in a particular case and may modify this Policy at any time. Contents of Policy REIMBURSEMENT POLICY STATEMENT ………………………………………………………….. 1 TABLE OF CONTENTS …………………………………………………………………………………… .. 1 A.SUBJECT ……………………………………………………………………………………………….. 2 B.BACKGROUND ……………………………………………………………………………………….. 2 C.DEFINITIONS ………………………………………………………………………………………….. 2 D.POLICY …………………………………………………………………………………………………. 2 E.CONDITIONS OF COVERAGE ………………………………………………………………….. 3 F.RELATED POLICIES/RUL ES ……………………………………………………………………. 3 G.REVIEW/REVISION HISTORY ………………………….. ……………………………………… 4 H.REFERENCES ………………………………………………………………………………………… 4Archived Positive Airway Pressure Devices for Pulmonary Disorders Ohio Medicaid PY-0313 Effective Date: 11/01/2017 2 A. SUBJECT Positive Airway Pressure Devices for Pulmonary Disorders B. BACKGROUND Reimbursement policies are designed to assist you when submitting claims to CareSource. They are routinely updated to promote accurate coding and policy clarification. These proprietary policies are not a guarantee of payment. Reimbursement for claims may be subject to limitations and/or qualifications. Reimbursement will be established based upon a review of the actual services provided to a member and will be determined when the claim is received for processing. Health care providers and their office staff are encouraged to use self-service channels to verify members eligibility. It is the responsibility of the submitting provider to submit the most accurate and appropriate CPT/HCPCS code(s) for the product or service that is being provided. The inclusion of a code in this policy does not imply any right to reimbursement or guarantee claims payment. Positive airway pressure (PAP) devices, involve using a machine that includes a mask or other device that fits over the nose and/or mouth to provide positive pressure to keep breathing airways open. Continuous positive airway pressure or CPAP is used to treat sleep-related breathing disorders including sleep apnea. It also may be used to treat preterm infants who have underdeveloped lungs. Bilevel or two level positive airway pressure or BiPAP is used to treat lung disorders such as chronic obstructive pulmonary disease (COPD). While CPAP delivers a single pressure, BiPAP delivers positive pressure both on inhalation and exhalation. PAP can provide better sleep quality, reduction or elimination of snoring, and less daytime sleepiness. The PAP machines should always be used according to the physicians order as well as every time during sleep at home, while traveling, and during naps in order to produce the most effective outcome C. DEFINITIONS Medically necessary health products, supplies or services that are necessary for the diagnosis or treatment of disease, illness, or injury and meet accepted guidelines of medical practice. Adherence is the use of the device regularly as prescribed by the ordering physician. Deviation is the altered or lack of use of the device as prescribed by the ordering physician. D. POLICY I. CareSource does not require a prior authorization for the first 3 month rental on a PAP machines (CPAP/BiPAP) . A. CPAP (E0601) machines and BiPAP (E0470) are a 10 month rent to purchase. B. Prior authorization must be obtain through CareSource starting after the 3 rdmonth rental (months 4-10). C. BiPAP machines (E0471) are a continuous rental and are never cap out as a purchase II.Providers that dispense the PAP machine must ensure and document the members compliance with its use. A. CareSource considers adherence with the use of PAP as the following: 1. The member uses the device regularly as prescribed by the ordering physician. 2. If there is a discontinuation of use at any time, the PAP supplier is expected to ascertain adherence and stop billing for the equipment, related accessories and supplies. Archived Positive Airway Pressure Devices for Pulmonary Disorders Ohio Medicaid PY-0313 Effective Date: 11/01/2017 3 3. The member has follow-up appointments with the ordering physician to determine effectiveness and that documentation is keep on file with the supplier and will be made available upon request by CareSource if needed. III. When lack of adherence or deviation from the ordered use of a PAP machine is confirmed, the PAP machine, further rental and providers claims will be denied. A. Any reimbursement that was dispersed during the time of deviation will be recouped by CareSource. B. Any supplies that were dispensed during the time of deviation will be recouped by CareSource. Note:Although CareSource does not require a prior authorization during the first 3 months of use, CareSource may request documentation to support medical necessity that shows adherence to the ordered use of the PAP machine. Appropriate and complete documentation must be presented at the time of review to validate medical necessity. E.CONDITIONS OF COVERA GE Reimbursement is dependent on, but not limited to, submitting Ohio Medicaid approved HCPCS and CPT codes along with appropriate modifiers. Please refer to the Ohio Medicaid fee schedule http://codes.ohio.gov/pdf/oh/admin/2016/5160-10-03_ph_ff_a_app2_20160321_1242.pdf The following PDF list(s) of codes is provided as a reference. This list may not be all inclusive and is subject to updates. Please refer to the above referenced source for the most current coding information. Code Description A4604 Tubing with integrated heating element for use with positive airway pressure device A7030 Full face mask used with positive airway pressure device A7031 Face mask interface, replacement for full face mask A7032 Cushion for use on nasal mask interface, r eplacement only A7033 Pillow for use on nasal cannula type interface, replacement only, pair A7034 Nasal interface (mask or cannula type) used with positive airway pressure device, with or without head strap A7035 Headgear used with positive airway pressure device A7037 Tubing used with positive airway pressure device A7038 Filter, disposable, used with positive airway pressure device A7039 Filter, non-disposable, used with positive airway pressure device E0470 Respiratory assist device, bi-level pressure capability, without backup rate feature E0471 Respiratory assist device, bi-level pressure capability, with back-up rate feature E0472 Respiratory assist device, bi-level pressure capability, with backup rate feature, used with invasive interfa ce E0601 Continuous positive airway pressure (CPAP) device F. RELATED POLICIES/RUL ES MCG Ambulatory Care 21st Edition ACG: A-0337 CPAP Titration, Home (APAP) MCG Ambulatory Care 21st Edition ACG: A-0338 CPAP Titration, Sleep Center MCG Ambulatory Care 21st Edition ACG: A-0431 Noninvasive Positive Pressure Ventilation (CPAP, BiPAP) ArchivedPositive Airway Pressure Devices for Pulmonary Disorders Ohio Medicaid PY-0313 Effective Date: 11/01/2017 4 G. REVIEW/REVISION HISTORY DATE ACTION Date Issued 1 1/01/2017 New Policy. Date Revised Date Effective 1 1/01/2017 H. REFERENCES 1. CPAP-NHLBI, NIH. (2016, December 9). Retrieved 5/8/2017 from https://www.nhlbi.nih.gov/health/health-topics/topics/cpap/ 2. CPAP vs BiPAP-American Sleep Association. (2017). Retrieved 5/21/2017 from https://www.sleepassociation.org/cpap-vs-bipap/ 3. Lawriter-OAC-5160-10-22 Volume ventilators, positive and negative pressure ventilators, continuous positive airway pressure (CPAP), alternating positive airway pressure (APAP), and intermittent positive pressure ventilation (IPPV). (2013, January 1). Retrieved 5/8/2017 from http://codes.ohio.gov/oac/5160-10-22 4. Milliman Guidelines (MCG). 2017. The Reimbursement Policy Stateme nt detai led above has received due con side ration as defined in the Reimbursement Po licy Stateme nt Po licy a nd is a pprove d. Archived
REIMBURSEMENT POLICY STATEMENTOHIO MEDICAID Original Issue Date Next Annual Review Effective Date 11/01/2017 11/01/2018 11/01/2017-10/22/2020 Policy Name Policy Number Occupational and Physical Therapy PY-0030 Policy Type Medical Administrative Pharmacy REIMBURSEMENT Contents of PolicyREIMBURSEMENT POLICY STATEMENT ………………………….. ………………………….. …….. 1 TABLE OF CONTENTS ………………………….. ………………………….. ………………………….. ……. 1 A. SUBJECT ………………………….. ………………………….. ………………………….. ……………….. 2 B. BACKGROUND ………………………….. ………………………….. ………………………….. ………. 2 C. DEFINITIONS ………………………….. ………………………….. ………………………….. …………. 2 D. POLICY ………………………….. ………………………….. ………………………….. …………………. 2 E. CONDITIONS OF COVERAGE ………………………….. ………………………….. …………….. 4 F. RELATED POLICIES/RULES ………………………….. ………………………….. ……………….. 4 G. REVIEW/REVISION HISTORY ………………………….. ………………………….. …………….. 4 H. REFERENCES ………………………….. ………………………….. ………………………….. ……….. 4 Reimbursement Policies prepared by CSMG Co. and its affiliates (including CareSource) are intended to provide a general reference regarding billing, coding and documentation guidelines. Coding methodology, regulatory requirements, industry-standard claims editing logic, benefits design and other factors are considered in developing Reimbursement Policies. In addition to this Policy, Reimbursement of services is subject to mem ber benefits and eligibility on the date of service, medical necessity, adherence to plan policies and procedures, claims editing logic, provider contractual agreement, and applicable referral, authorization, notification and utilization management guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be exp ected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost altern ative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any federal or state coverage mandate, Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. This Policy does not ensure an authorization or Reimbursement of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) refer enced herein. If there is a conflict between this Policy and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. CSMG Co. and its affiliates may use reasonable discretion in interpreting and applying this Policy to services provided in a particular case and may modify this Policy at any time. A. SUBJECTOccupational and Physical Therapy Occup ational and Physical Therap y Ohio Med icaid PY-0030 Ef fective Date: 11/01/2017 B. BACKGROUND Reimb ursement p olicies are d esigned to assist you when submitting claims to CareSource. They are ro utinely updated to p romote accurate coding and policy clarification. These proprietary p o licies are not a g uarantee of payment. Reimb ursement for claims may be subject to limitations and /o r q ualifications. Reimbursement will b e established b ased upon a review of the actual services provided to a member and will be d etermined when the claim is received for p rocessing. Health care p ro viders and their office staff are encourag ed to use self-service channels to verify memb ers eligibility. It is the resp o nsibility of the submit ting p rovider to submit the most accurate and ap propriateCPT/HCPCS co de(s) for the p roduct o r service that is being pro vided. The inclusion of a code in this p o licy does not imply any right to reimbursement o r guarantee claims p ayment. Occup ational and P hysical therapy services help improve the lives of patients through co mp rehensive evaluations, recommendations for adaptive equipment and training in its use, and g uid ance and ed ucation for family members and caregivers. Occup ational therapy (OT) focuses on ad apting the environment of the member to fit their need s.This includ es helping people regain skills after an injury, supporting older ad ults that have exp erienced a p hysical o r mental change and teaching children with d isabilities ho w to incre ase p articipation in school and social activities. Physical therapy (PT) focuses on increasing the members physical ability to participate in their enviro nment. This includ es helping people regain physical strength, f unction and independence and to red uce p ain after an injury or mental change. PT teaches members how to manage their p hysical condition, prevent further injury and achieve long-term health benefits. C. DEFINITIONS Medically necessary health products, supplies o r services that are necessary for the d iag no sis or treatment of d isease, illness, or injury and meet accepted g uidelines of med ical p ractice. Place OH MCD definition Physical Therapy – is a health p rofession that helps patients reduce pain and improve or resto re mo bility to achieve independence in their activities of d aily living. Occupational therapy – is a health profession that helps patients develop skills in o rder to achieve ind ependence in their activities of d aily living. D. POLICYI. CareSo urce members o ver 21 years of ag e may receive up to 30 visits for o utpatient physical therap y services per calendar year (January1 December 31 st) witho ut p rior authorization, if the p ro vider is a p articipating pro vider with CareSource. Ad d itional visits b eyond 30 require a p rio r autho rization. II. CareSo urce members o ver 21 years of ag e may receive up to 30 visits for o utpatient o ccupational therapy services per calendar year (January1 December 31 st) without prior autho rizatio n, if the provider is a p articipating pro vider with CareSource. Additional visits b eyo nd 30 req uire a p rior authorization. III. If the CareSo urce member is under 21 years of age, AND the pro vider is a p articipating p ro vider with CareSource, there is no prior authorization req uired an d there is no limit to the amo unt of visits for OT/PT services when medically necessary. Occup ational and Physical Therap yOhio Med icaid PY-0030 Ef fective Date: 11/01/2017 IV . Memb ers receiving therapy in the home (place of service 12) from a p articipating p rovider do no t req uire a p rior authorization and do not have a limit to the number of visits. V. Prio r autho rization is required for all non-participating p roviders for therapy services VI. Reimb ursement is based off of Ohio Administrative Co de 5160-8-33 skilled therapy:d o cumentation of services and Ohio Administrative Co de 5160-8-32 skilled therapy: co verage. For further information p lease refer to: http://codes.ohi o.gov/oac/5160-8-33 and http ://codes.ohio.gov/oac/5160-8-32 VII. Physical and Occupational therapy services: A. Includ es aq uatic and massage therapy B. Must be medically necessary and, und er accepted standards of medical practice, be co nsidered specific and effective treatment for the p atient’s condition. C. A clinical evaluation and assessment of the members need for OT/PT therap y services must include the following elements: 1. An ap p ropriate diagnosis of the disorder or a description of the p hysical or sensory f unctionality deficit. 2. A current review of the individual’s p hysical, aud itory, visual, motor, and cognitive status. 3. A case history, including the individual’s d evelopment and capacity to participate in therap y and if ap propriate, their familys perspectives 4. The o utco mes of standardized tests, no n-standardized tests o r other test results and interp retation that use age-appropriate developmental criteria. 5. An evaluatio n justifying the need for OT/PT therapy services, which may be exp ressed as o ne of two p rognoses of the p atient’s rehabilitative o r developmental p o tential: 5. 1 The p atient’s functionality is expected to improve within sixty (60) d ays after the evaluatio n because of the initiation of therapy services o r the patient’s f unctionality is expected to improve within six months after the evaluation due to OT/PT therap y services, and the patient is expected to attain full functionality or make sig nificant p rogress toward expected g oals within twelve months; or 5. 2 The p atient is not expected to attain full functionality or make significant progress to ward the expected goals within twelve months, b ut a safe and effective maintenance p rogram may be established; and 6. Any reco mmendations for further ap praisal, follow-up, or referral. VIII . Op hthalmologists may bill for code 97110 and 97530 for vision therapy, howeverOp to metrists reimbursement is based o n the providers specific contract and codes 97110 and 97530 may no t be rei mbursable. To confirm whether your contract reimburses for these co des, please contact your Health Partner rep resentative. IX . Reimb ursement is b ased on submitting a claim with the appropriate ICD-10 diagnosis code to match the OT/PT therap y service CPT code. See attached PDF. X. If the ap p ropriate ICD-10 diagnosis code is no t submitted with the CPT code, the claim will be d enied . XI. No n-Co vered ServicesA. Evaluations, in the absence of signs and symptoms, are not covered. B. Reevaluatio n may b e co vered, if necessary, b ecause of a chang e in the memb ers co nd ition, new clinical f indings o r f ailure to resp ond to the therap eutic interventions o utlined in the plan of care. Occup ational and Physical Therap yOhio Med icaid PY-0030 Ef fective Date: 11/01/2017 Note: Altho ug h occupational and physical therapy services do no t req uire a p rior autho rizatio n for the first 30 visits and has no limit for CareSource members under 21 years o f ag e, CareSource may request documentation to suppor t medical necessity. Ap p ropriate and complete d ocumentation must b e presented at the time of review to valid ate medical necessity. XII. CareSo urce f ollows the federal, state and contract g uidelines related to the p rovision of EPSDT Preventive Services & EPSDT Sp ecial Services (other necessary health services d eemed medically necessary/ d iagnostic services/ treatment services) E. CONDITIONS OF COVERAGE Reimb ursement is dependent o n, b ut not limited to, submitting Ohio Medicaid approved HCPCS and CPT co d es alo ng with appropriate modifiers. Please ref er to the Ohio Medicaid fee schedule http ://medicaid.ohio.gov/Portals/0/Providers/FeeScheduleRates/App-DD.pdf The following PDF list(s) of codes is provided as a reference. This list may not be all inc lusive and is subject to updates. Please refer to the above referenced source for the most current coding information. F. RELATED POLICIES/RULES G. REVIEW/REVISION HISTORY DATE ACTIONDate Issued 11/01/2017 New Po licy. Date Revised Date Effective 11/01/2017 Date Archived 10/22/2020 This Po licy is no lo nger active and has been archived . Please no te that there could be o ther Po licies that may have some of the same rules inco rp orated and CareSource reserves the rig ht to f ollow CMS/State/NCCI g uidelines without a f o rmal documented Policy H. REFERENCES 1. Ap p endix DD to rule 5160-1-60. (2017, January 1). Retrieved 3/23/2017 from http ://medicaid.ohio.gov/Portals/0/Providers/FeeScheduleRates/App-DD.pdf 2. Med ically Necessary – HealthCare.gov Glossary | HealthCare.gov. (2017, March 14). Retrieved 3/14/17 from https://www.healthcare.gov/glossary/medically-necessary/ 3. Ab o ut Occupational Therap y. (2017). Retrieved 4/5/2017 from http ://www.aota.org/About-Occupational-Therap y.aspx 4. Who Are Physical Therap ists? (2017). Retrieved 4/5/2017 from http ://www.apta.org/AboutPTs/ 5. Lawriter – OAC – 5160-8-33 Skilled therapy: documentation of services. (2014, January 1). Retrieved 3/27/17 fro m http://codes.ohio.gov/oac/5160-8-33 6. Lawriter – OAC – 5160-8-32 Skilled therapy: coverage. (2014, January 1). Retrieved 3/27/17 f ro m http://codes.ohio.gov/oac/5160-8-32 7. Ohio Dep artment of Medicaid – Co vered Services. (2017, March 27). Retrieved 3/27/17 f ro m http://medicaid.ohio.gov/FOROHIOANS/CoveredServices.aspx#652244 – o ccupational-therapy 8. Ohio Dep artment of Medicaid – Co vered Services. (2017, March 27). Retrieved 3/27/17 f ro m http ://med i c ai d .o hi o .g o v /FOROHI OA NS / Co v e red Se rv i c es .as p x #6 52 2 43-p hy s i c a l – therap y The Payment Policy Statement detailed above has received due consideration as defined in the Payment Policy Statement Policy and is approved.
REIMBURSEMENT POLICY STATEMENT OHIO MEDICAID Original Issue Date Next Annual Review Effective Date 08/08/2016 08/18/201 8 09/27/2017 Policy Name Policy Number Genetic Testing-Polymerase Chain Reaction PY-0101 Policy Type Medical Administrative Pharmacy REIMBURSEMENT Reimbursement Policies prepared by CSMG Co. and its affiliates (including CareSource) are intended to provide a general reference regarding billing, coding and documentation guidelines. Coding methodology, regulatory requirements, industry-standard claims editing logic, benefits design and other factors are considered in developing Reimbursement Policies. In addition to this Policy, Reimbursement of se rvices is subject to member benefits and eligibility on the date of service, medical necessity, adherence to plan policies and procedures, claims editing logic, provider contractual agreement, and applicable re ferral, authorization, notification and utiliz ation management guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any federal or state coverage mandate, Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. This Policy does not ensure an authorization or Reimbursement of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) ref erenced herein. If there is a conflict between this Policy and the plan contract ( i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. CSMG Co. and its affiliat es may use reasonable discretion in interpreting and applying this Policy to services provided in a particular case and may modify this Policy at any time. Contents of Policy REIMBURSEMENT POLICY STATEMENT ………………………………………………………….. 1 TABLE OF CONTENTS …………………………………………………………………………………… .. 1 A.SUBJECT ……………………………………………………………………………………………….. 2 B.BACKGROUND ……………………………………………………………………………………….. 2 C.DEFINITIONS ………………………………………………………………………………………….. 2 D.POLICY ………………………………………………………………………………………………….. 2 E.CONDITIONS OF COVERA GE ………………………………………………………………….. 4 F.RELATED POLICIES/RUL ES ……………………………………………………………………. 5 G.REVIEW/REVISION HISTORY ………………………….. ……………………………………… 5 H.REFERENCES ………………………………………………………………………………………… 5Archived Genetic Testing-Polymerase Chain Reaction Ohio Medicaid PY-0101 Effective Date:09/27/2017 2 A.SUBJECT Genetic Testing-Polymerase Chain Reaction B. BACKGROUND Polymerase Chain Reaction (PCR) is a genetic amplification technique that only requires small quantities of DNA, for example, 0.1 mg of DNA from a single cell, to achieve DNA analysis in a shorter laboratory processing time period. Knowing the gene sequence, or at minimum the borders of the target segment of DNA to be amplified, is a prerequisite to a successful PCR amplification of DNA. PCR plays a diagnostic role when selected pathogens pose difficulties for specimen collection or culture characteristics (time, environment, or substrate constraints). For example, evaluating viral load by PCR technique for HIV helps gauge response to therapies. However, the technique is also so sensitive that amplified contaminant DNA is problematic to achieving valid test results. False positive results may also occur if DNA from one specimen contaminates another. The technique cannot distinguish DNA from colonizing organisms, or even DNA from dead microbes in a specimen, from those causing clinically significant infections. In fact, for many types of microbes the test sensitivities, specificities, and predictive values of PCR gene testing are not reported for large patient groups. Repeated cycles of synthesizing complementary strands of DNA are performed in a stepwise manner up to 30 times to achieve adequate gene amplification for diagnosis. Cycles involve 1) denaturing DNA with heat to create single strands, 2) annealing PCR primers of oligonucleotides (short pieces of DNA of 20-30 base pairs each) to the DNA to be amplified, and 3) enzymatic synthesis of complementary DNA with Taq polymerase or Pfu polymerase. All facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria. Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof. Errors can occur anywhere in the testing process, particularly when the manufacturer’s instructions are not followed and when testing personnel are not familiar with all aspects of the test system. Some waived tests have potential for serious health impacts and unintended consequences if performed incorrectly. To decrease the risk of erroneous results, the test needs to be performed correctly, by trained personnel and in an environment where good laboratory practices are followed. CareSource may periodically require review of a providers office testing policies and procedures when performing CLIA-waived tests. CareSource will cover influenza testing with the CPT 87502 only when a CLIA-waived manufacturer testing system performs gene amplification by polymerase chain reaction (PCR) or nucleic acid amplification technology (NAT) testing. Appropriate indications must be documented in the members medical record and available for review by CareSource upon request. C. DEFINITIONS Polymerase Chain Reaction (PCR) – a genetic amplification technique also known as a Nucleic Acid Amplification Test (NAAT) D. POLICY I. A Prior Authorization is not required for selected PCR testing. Archived Genetic Testing-Polymerase Chain Reaction Ohio Medicaid PY-0101 Effective Date:09/27/2017 3 II. CareSource considers nucleic acid amplification testing (NAAT) by polymerase chain reaction (PCR) to be medically necessary for the following indications in oncology and heritable conditions: A. Chronic Lymphocytic Leukemia (CLL) [1] B. BCR-ABL testing for Chronic Myelogenous Leukemia (CML) [2] [3] [4] C. Mucosa-Associated Lymphoid Tissue (MALT) [5] D. Lynch syndrome [6] [7] E. BRAF mutation which is seen in colorectal carcinoma, gliomas, hepatobiliary carcinomas, melanoma, papillary thyroid carcinoma, ovarian teratomas and serous tumors, and hairy-cell leukemia (HCL). [8,9] F. The use of PCR gene testing for persons who meet criteria has been demonstrated in a variety of heritable conditions and is supported by published literature or endorsed by consensus professional societies. These conditions include certain primary thrombophilias[10], Tay-Sachs and Canavan diseases[11], Fabry disease[12], Gaucher disease[13], Niemann-pick disease[14], Hemochromatosis[15], Rett syndrome[16], Huntington’s disease[17], Celiac disease[18], Ankylosing spondylitis[19], Prader-Willi or Angelman syndrome, and other short-stature syndromes[20], Fragile Xsyndrome[21], and sickle-cell disease[22]. Applications of selected PCR techniques are also part of the workup and management for candidates donating organs and tissues. [23, 24] The first-line screening test for Tay-Sachs remains an enzyme activity test rather than genotyping. Genotyping is used for preimplantation diagnosis and confirmatory testing. In contrast, DNA-based testing is used for Canavan screening and diagnosis. G. Methylenetetrahydrofolate reductase (MTHFR) polymorphism testing has little clinical utility and does not meet medical necessity criteria as meta-analyses have disproven an association between elevated homocysteine and risk for coronary artery disease and between MTHFR polymorphisms and risk for venous thromboembolism.[25] III. CareSource considers NAAT by PCR to be medically necessary for the following indications in infectious disease management: A. Shiga toxin –producing Escherichia coli (STEC) [26] B. C. difficile enterocolitis [27-29] C. Entamoeba species [30,31] D. Tuberculosis[32] E. Staphylococcus aureus[33] F. Actinomyces species may be identified in tissue specimens with a 16s rRNA sequencing and PCR assay.[34, 35] G. Dengue is a mosquito-borne febrile illness and diagnosis requires laboratory confirmation by culture, NAAT or testing for dengue specific antibodies.[37] For other mosquito-borne illnesses such as West Nile virus and Zika, PCR also has diagnostic utility, including in saliva tests.[38] Ebola may be diagnosed by PCR techniques on plasma.[39] IV. CareSource considers viral PCR testing in conjunction with a Clinical Laboratory Improvement Amendments (CLIA)-approved reference lab as medically necessary for indications endorsed in a primary or supplemental diagnostic approach as described by the Infectious Diseases Society of America (IDSA). [40] Many molecular diagnostic tests for viral pathogens include PCR techniques, offered by CLIA-certified reference laboratories. Viral syndrome testing is considered based on the patient’s age, history, immune status, and other variables. According to the IDSA, diagnostic samples are obtained and tested for the most likely agents.[40] Samples are commonly held frozen in the microbiology laboratory for additional testing if necessary, given that it is not cost-effective to test initial samples broadly for multiple viruses.[40] These viral pathogens include: A. Herpes virus infections [41, 42], Varicella and Zoster[43], Measles[44], Mumps[45], Cytomegalovirus [40], Adenovirus [40], Enterovirus [42], and Parvovirus [40]. Archived Genetic Testing-Polymerase Chain Reaction Ohio Medicaid PY-0101 Effective Date:09/27/2017 4 B.For persons with positive HIV, antigen/antibody combination immunoassays and either HIV-1 negative or indeterminate HIV-2 differentiation immunoassay, PCR testing is indicated.[40, 46, 47] C. The diagnosis of hepatitis B (HBV) or C (HCV) typically begins with an antibody test for screening or in the presence of acute hepatitis. For hepatitis B, PCR viral genetic assays may be applied to determine viral genotype, detecting genotypic drug resistance mutations, and identifying core promoter/ precore mutations.[48] For hepatitis C, persons with positive screening test results should undergo confirmatory or supplemental testing for HCV RNA by molecular test methods. V. PCR techniques have been developed for a variety of respiratory pathogens and may be included in diagnostic algorithms for affected persons in the pediatric and adult populations. The Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) consensus guidelines on the management of community-acquired pneumonia in adults report that testing is optional for persons who are not hospitalized [49]. However, patients who require hospitalization should have pretreatment blood cultures, culture and Gram stain of good-quality samples of expectorated sputum and, if disease is severe, urinary antigen tests for S. pneumoniae and Legionella pneumophila, when available. [49] Evaluation of bronchoscopically obtained samples and/or thoracentesis-obtained samples of pleural fluid may be necessary for diagnosis in hospitalized persons unable to produce a sputum sample. PCR testing may be applied in selected cases where microorganisms are suspected based upon age, history, immune status, and other variables. PCR testing is available for Mycoplasma. [49] VI. CareSource considers PCR testing for pathogens of other types or in other anatomic sites medically necessary as described by the IDSA and the American Society for Microbiology (ASM) in A Guide to Utilization of the Microbiology Laboratory for Diagnos is of Infectious Diseases: 2013 Recommendations by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM).[40] Guidelines were developed by both laboratory and clinical experts and provides information on which tests are valuable and in which contexts, and on tests that add little or no value for diagnostic decisions.[40] VII. For many pathogens, while a PCR test is available, the clinical utility is not clearly defined by available evidence, evidence is insufficient or inconclusive, or there is no support for quantification PCR testing. For Bartonella henselae and quintona species, immunofluorescent antibody assay serology is sensitive and specific, and there is no inconclusive evidence of an indication for quantification. [50, 51]. For many pathogens, such as Chlamydia pneumoniae, Hepatitis G, herpes simplex virus (HSV), Herpes virus-6, Legionella pneumophilia, Mycobacteria avium-intracellulare, Mycoplasma pneumoniae, Neisseria gonorrhoeae, and Streptococcus, group A guidelines from the IDSA do not have a recommendation for quantification.[40] VIII. For sexually transmitted infections including Chlamydia, Gonorrhea, Syphilis, and other pathogens, refer to the CareSource Sexually Transmitted Infection (STI) policy. E. CONDITIONS OF COVERA GE HCPCS CPT AUTHORIZATION PERIOD Archived Genetic Testing-Polymerase Chain Reaction Ohio Medicaid PY-0101 Effective Date:09/27/2017 5 F.RELATED POLICIES/RUL ES 1. Genetic Testing, Genetic Screening and Genetic Counseling (MM-0003) 2. Sexually Transmitted Infections (PY-0037) G. REVIEW/REVISION HISTORY DATE ACTION Date Issued 8/16/2016 Date Revised 8/ 16/2016, 9/26/2016, 11/15/2016 09/26/2016 Removed Cystic Fibrosis criteria and reference. 08/31/2017 8/31/2017-removed expansive clinical explanations, added 87511, 87481, 87507, 87530 and 87541 as covered CPT codes; updated diagnosis codes and added PDF with CPT codes and ICD-10. Date Effective 09/27/2017 H. REFERENCES [1] D. Kienle, A. Benner, C. Laufle, D. Winkler, C. Schneider, A. Buhler , et al., “Gene expression factors as predictors of genetic risk and survival in chronic lymphocytic leukemia,” Haematologica, vol. 95, pp. 102-9, Jan 2010. [2] F. Notta, C. G. Mullighan, J. C. Wang, A. Poeppl, S. Doulatov, L. A. Phillips , et al., “Evolution of human BCR-ABL1 lymphoblastic leukaemia-initiating cells,” Nature, vol. 469, pp. 362-367, 2011. [3] A. A. Darji and P. D. Bharadia, “CHRONIC MYELOGENOUS LEUKEMIA: A REVIEW AND UPDATE OF CURRENT AND FUTURE THERAPY,” International Journal of Pharmacy and Pharmaceutical Sciences, vol. 8, 2016. [4] M. W. Deininger, “Molecular monitoring in CML and the prospects for treatment-free remissions,” Hematology Am Soc Hematol Educ Program, vol. 2015, pp. 257-63, 2015. [5] A. D. Zelenetz, J. S. Abramson, R. H. Advani, C. B. Andreadis, J. C. Byrd, M. S. Czuczman , et al. , “NCCN Clinical Practice Guidelines in Oncology: non-Hodgkin’s lymphomas,” JNatl Compr Canc Netw, vol. 8, pp. 288-334, Mar 2010. [6] H. Hampel, “NCCN increases the emphasis on genetic/familial high-risk assessment in [7] K. M. Chin, B. Wessler, P. Chew, and J. Lau, “Genetic Tests for Cancer,” in Genetic Tests for Cancer , ed Rockville (MD), 2006. [8] P. G. Febbo, M. Ladanyi, K. D. Aldape, A. M. De Marzo, M. E. Hammond, D. F. Hayes , et al., “NCCN Task Force report: Evaluating the clinical utility of tumor markers in oncology,” Journal of the National Comprehensive Cancer Network, vol. 9, pp. S-1-S-32, 2011. [9] S. Pakneshan, A. Salajegheh, R. A. Smith, and A. K. Lam, “Clinicopathological relevance of BRAF mutations in human cancer,” Pathology, vol. 45, pp. 346-56, Jun 2013. [10] S. Moll, “W ho should be tested for thrombophilia?,” Genet Med, vol. 13, pp. 19-20, 01//print 2011. [11] A. Colaianni, S. Chandrasekharan, and R. Cook-Deegan, “Impact of gene patents and licensing practices on access to genetic testing and carrier screening for Tay-Sachs and Canavan disease,” Genet Med, vol. 12, pp. S5-S14, 04//print 2010. [12] R. Schiffmann, M. Fuller, L. A. Clarke, and J. M. F. G. Aerts, “Is it Fabry disease?,” Genet Med, 05/19/online 2016. [13] C. R. Scott, G. Pastores, H. Andersson, J. Charrow, P. Kaplan, E. Kolodny , et al., “The clinical expression of Gaucher disease correlates with genotype: Data from 570 patients,” Genet Med, vol. 2, pp. 65-65, 01//print 2000. [14] R. Y. Wang, O. A. Bodamer, M. S. Watson, and W. R. Wilcox, “Lysosomal storage diseases: Diagnostic confirmation and management of presymptomatic individuals,” Genet Med, vol. 13, pp. 457-484, 05//print 2011. Archived Genetic Testing-Polymerase Chain Reaction Ohio Medicaid PY-0101 Effective Date:09/27/2017 6 [15] C. Mura, O. Raguenes, V. Scotet, S. Jacolot, A.-Y. Mercier, and C. Ferec, “A 6-year survey of HFE gene test for hemochromatosis diagnosis,” Genet Med, vol. 7, pp. 68-73, 01//print 2005. [16] T. Bienvenu and J. Chelly, “Molecular genetics of Rett syndrome: when DNA methylation goes unrecognized,” Nat Rev Genet, vol. 7, pp. 415-426, 06//print 2006. [17] W. H. Rogowski, S. D. Grosse, and M. J. Khoury, “Challenges of translating genetic tests into clinical and public health practice,” Nat Rev Genet, vol. 10, pp. 489-495, 07//print 2009. [18] G. J. Tack, W. H. M. Verbeek, M. W. J. Schreurs, and C. J. J. Mulder, “The spectrum of celiac disease: epidemiology, clinical aspects and treatment,” Nat Rev Gastroenterol Hepatol, vol. 7, pp. 204-213, 04//print 2010. [19] L.-S. Tam, J. Gu, and D. Yu, “Pathogenesis of ankylosing spondylitis,” Nat Rev Rheumatol, vol. 6, pp. 399-405, 07//print 2010. [20] S. B. Cassidy, S. Schwartz, J. L. Miller, and D. J. Driscoll, “Prader-Willi syndrome,” Genet Med, vol. 14, pp. 10-26, 01//print 2012. [21] D. C. Crawford, J. M. Acuna, and S. L. Sherman, “FMR1 and the fragile Xsyndrome: Human genome epidemiology review,” Genet Med, vol. 3, pp. 359-371, 09//print 2001. [22] M. Bender and G. D. Seibel, “Sickle cell disease,” 2014. [23] N. Kamani, S. Spellman, C. K. Hurley, J. N. Barker, F. O. Smith, M. Oudshoorn , et al., “State of the art review: HLA matching and outcome of unrelated donor umbilical cord blood transplants,” Biol Blood Marrow Transplant, vol. 14, pp. 1-6, Jan 2008. [24] L. D’Orsogna, S. Fidler, A. Irish, B. Saker, H. Moody, and F. T. Christiansen, “HLA donor-specific antibody detected by solid phase assay identifies high-risk transplantation pairs irrespective of CDC crossmatch results: case reports and literature review,” Clin Transpl, pp. 497-501, 2006. [25] S. E. Hickey, C. J. Curry, and H. V. Toriello, “ACMG Practice Guideline: lack of evidence for MTHFR polymorphism testing,” Genet Med, vol. 15, pp. 153-6, Feb 2013. [26] L. H. Gould, C. Bopp, N. Strockbine, R. Atkinson, V. Baselski, B. Body , et al., “Recommendations for diagnosis of shiga toxin –producing Escherichia coli infections by clinical laboratories,” MMWR Recomm Rep, vol. 58, pp. 1-14, Oct 16 2009. [27] S. H. Cohen, D. N. Gerding, S. Johnson, C. P. Kelly, V. G. Loo, L. C. McDonald , et al., “Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the society for healthcare epidemiology of America (SHEA) and the infectious diseases society of America (IDSA),” Infect Control Hosp Epidemiol, vol. 31, pp. 431-55, May 2010. [28] S. B. Selvaraju, M. Gripka, K. Estes, A. Nguyen, M. A. Jackson, and R. Selvarangan, “Detection of toxigenic Clostridium difficile in pediatric stool samples: an evaluation of Quik Check Complete Antigen assay, BD GeneOhm Cdiff PCR, and ProGastro Cd PCR assays,” Diagnostic Microbiology and Infectious Disease, vol. 71, pp. 224-229, 11// 2011. [29] M. H. Wilcox, T. Planche, F. C. Fang, and P. Gilligan, “What is the current role of algorithmic approaches for diagnosis of Clostridium difficile infection?,” JClin Microbiol, vol. 48, pp. 4347-53, Dec 2010. [30] S. Roy, M. Kabir, D. Mondal, I. K. M. Ali, W. A. Petri, and R. Haque, “Real-time-PCR assay for diagnosis of Entamoeba histolytica infection,” Journal of clinical microbiology, vol. 43, pp. 2168-2172, 2005. [31] S. Solaymani-Mohammadi, C. M. Coyle, S. M. Factor, and W. A. Petri Jr, “Amebic colitis in an antigenically and serologically negative patient: usefulness of a small-subunit ribosomal RNA gene-based polymerase chain reaction in diagnosis,” Diagnostic Microbiology and Infectious Disease, vol. 62, pp. 333-335, 11// 2008. [32] P. Nahid, S. E. Dorman, N. Alipanah, P. M. Barry, J. L. Brozek, A. Cattamanchi , et al., “Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis,” Clinical Infectious Diseases, p. ciw376, 2016. [33] D. L. Stevens, A. L. Bisno, H. F. Chambers, E. P. Dellinger, E. J. Goldstein, S. L. Gorbach , et al. , “Practice guidelines for the diagnosis and management of skin and soft tissue ArchivedGenetic Testing-Polymerase Chain Reaction Ohio Medicaid PY-0101 Effective Date:09/27/2017 7 infections: 2014 update by the Infectious Diseases Society of America,” Clinical Infectious Diseases, vol. 59, pp. e10-e52, 2014. [34] M. J. Belmont, P. M. Behar, and M. K. Wax, “Atypical presentations of actinomycosis,” Head & neck, vol. 21, pp. 264-268, 1999. [35] T. Hansen, M. Kunkel, E. Springer, C. Walter, A. Weber, E. Siegel , et al., “Actinomycosis of the jaws –histopathological study of 45 patients shows significant involvement in bisphosphonate-associated osteonecrosis and infected osteoradionecrosis,” Virchows Arch, vol. 451, pp. 1009-17, Dec 2007. [36] C. L. Schroeder, H. P. Narra, M. Rojas, A. Sahni, J. Patel, K. Khanipov , et al., “Bacterial small RNAs in the Genus Rickettsia,” BMC Genomics, vol. 16, p. 1075, 2015. [37] M. G. Teixeira and M. L. Barreto, “Diagnosis and management of dengue,” BMJ, vol. 339, 2009. [38] D. Musso, C. Roche, T. X. Nhan, E. Robin, A. Teissier, and V. M. Cao-Lormeau, “Detection of Zika virus in saliva,” JClin Virol, vol. 68, pp. 53-5, Jul 2015. [39] J. R. Spengler, A. K. McElroy, J. R. Harmon, U. Stroher, S. T. Nichol, and C. F. Spiropoulou, “Relationship Between Ebola Virus Real-Time Quantitative Polymerase Chain Reaction-Based Threshold Cycle Value and Virus Isolation From Human Plasma,” JInfect Dis, vol. 212 Suppl 2, pp. S346-9, Oct 1 2015. [40] E. J. Baron, J. M. Miller, M. P. Weinstein, S. S. Richter, P. H. Gilligan, R. B. Thomson , et al., “A Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious Diseases: 2013 Recommendations by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM) a,” Clinical Infectious Diseases, vol. 57, pp. e22-e121, August 15, 2013 2013. [41] D. W . Kimberlin, “Diagnosis of herpes simplex virus in the era of polymerase chain reaction,” The Pediatric infectious disease journal, vol. 25, pp. 841-842, 2006. [42] R. L. DeBiasi and K. L. Tyler, “Molecular methods for diagnosis of viral encephalitis,” Clinical microbiology reviews, vol. 17, pp. 903-925, 2004. [43] P. A. Thomas and P. Geraldine, “Infectious keratitis,” Current opinion in infectious diseases, vol. 20, pp. 129-141, 2007. [44] R. S. van Binnendijk, S. van den Hof, H. van den Kerkhof, R. H. G. Kohl, F. Woonink, G. A. M. Berbers , et al., “Evaluation of Serological and Virological Tests in the Diagnosis of Clinical and Subclinical Measles Virus Infections during an Outbreak of Measles in The Netherlands,” Journal of Infectious Diseases, vol. 188, pp. 898-903, September 15, 2003 2003. [45] C. H. Krause, K. Eastick, and M. M. Ogilvie, “Real-time PCR for mumps diagnosis on clinical specimens comparison with results of conventional methods of virus detection and nested PCR,” Journal of clinical virology, vol. 37, pp. 184-189, 2006. [46] CDC. (2014, Quick reference guide-Laboratory testing for the diagnosis of HIV infection : updated recommendations. CDC Stacks. Available: https://stacks.cdc.gov/view/cdc/23446 [47] G. Murphy and C. Aitken, “HIV testing the perspective from across the pond,” Journal of Clinical Virology, vol. 52, pp. S71-S76, 2011. [48] A. Valsamakis, “Molecular testing in the diagnosis and management of chronic hepatitis B,” Clinical microbiology reviews, vol. 20, pp. 426-439, 2007. [49] L. A. Mandell, R. G. Wunderink, A. Anzueto, J. G. Bartlett, G. D. Campbell, N. C. Dean , et al. , “Infectious Diseases Society of America/American Thoracic Society Consensus Guidelines on the Management of Community-Acquired Pneumonia in Adults,” Clinical Infectious Diseases, vol. 44, pp. S27-S72, March 1, 2007 2007. [50] P. E. Fournier, J. L. Mainardi, and D. Raoult, “Value of microimmunofluorescence for diagnosis and follow-up of Bartonella endocarditis,” Clin Diagn Lab Immunol, vol. 9, pp. 795-801, Jul 2002. [51] L. M. Mofenson, M. T. Brady, S. P. Danner, K. L. Dominguez, R. Hazra, E. Handelsman , et al., “Guidelines for the Prevention and Treatment of Opportunistic Infections among HIVexposed and HIV-infected children: recommendations from CDC, the National Institutes of Health, the HIV Medicine Association of the Infectious Diseases Society of America, the ArchivedGenetic Testing-Polymerase Chain Reaction Ohio Medicaid PY-0101 Effective Date:09/27/2017 8 Pediatric Infectious Diseases Society, and the American Academy of Pediatrics,” MMWR Recomm Rep, vol. 58, pp. 1-166, Sep 4 2009. [52] K. A. Workowski, S. Berman, C. Centers for Disease, and Prevention, “Sexually transmitted diseases treatment guidelines, 2010,” MMWR Recomm Rep, vol. 59, pp. 1-110, Dec 17 2010. [53] ACOG, “ACOG Practice Bulletin. Clinical management guidelines for obstetrician-gynecologists, Number 72, May 2006: Vaginitis,” Obstet Gynecol, vol. 107, pp. 1195-1206, May 2006. The Reimbursement Policy Stateme nt det ailed a bove has r eceived due consi deration as defined in the ReimbursementPo li cy Stateme nt Po li cy a nd is a pprove d. Archived
REIMBURSEMENT POLICY STATEMENT OHIO MEDICAIDOriginal Issue Date Next Annual Review Effective Date 07/01/2013 01/02/2020 01/02/2019 Policy Name Policy Number Bilateral Procedures PY-0012 Policy Type Medical Administrative Pharmacy REIMBURSEMENT Reimbursement Policies prepared by CSMG Co. and its affiliates (including CareSource) are intended to provide a general reference regarding billing, coding and documentation guidelines. Coding methodology, regulatory requirements, industry-standard claims editing logic , benefits design and other factors are considered in developing Reimbursement Policies. In addition to this Policy, Reimbursement of services is subject to member benefits and eligibility on the date of service, medical necessity, adherence to plan policies and procedures, claims editing logic, provider contractual agreement, and applicable re ferral, authorization, notification and utilization management guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patien t can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowes t cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any federal or state coverage mandate, Evidence of Coverage documents, Medical Policy Statem ents, Provider Manuals, Member Handbooks, and/or other policies and procedures. This Policy does not ensure an authorization or Reimbursement of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service (s) referenced herein. If there is a conflict between this Policy and the plan contract ( i.e. , Evidence of Coverage), then the plan contract ( i.e. , Evidence of Coverage) will be the controlling document used to make the determination. CSMG Co. and its affiliates may use reasonable discretion in interpreting and applying this Policy to services provided in a particular case and may modify this Policy at any time. Contents of Policy REIMBURSEMENT POLICY STATEMENT ………………………….. ………………………….. …. 1 TABLE OF CONTENTS ………………………….. ………………………….. ………………………….. .. 1 A. SUBJECT ………………………….. ………………………….. ………………………….. ………….. 2B. BACKGROUND ………………………….. ………………………….. ………………………….. ….. 2C. DEFINITIONS ………………………….. ………………………….. ………………………….. …….. 2D. POLICY 2E. CONDITIONS OF COVERA GE ………………………….. ………………………….. …………. 4 F. RELATED POLICIES/RUL ES ………………………….. ………………………….. …………… 4 G. REVIEW/REVISION HIST ORY ………………………….. ………………………….. …………. 4 H. REFERENCES ………………………….. ………………………….. ………………………….. …… 4 Archived Bilateral Procedures Ohio Med icaid PY-0012 Effective Date: 02 /0 2 /201 9 2 A. SUBJECT Bilateral Procedures B. BACKGROUND Reimbursement policies are designed to assist you when submitting claims to CareSource. They are routinely updated to promote accurate coding and policy clarification. These proprietary policies are not a guarantee of payment. Reimbursement for claims may be subject to limitations and/or qualifications. Reimbursement will be established based upon a review of the actual services provided to a member and w ill be determined when the claim is received for processing. Health care providers and their office staff are encouraged to use self-service channels to verify members eligibility. It is the responsibility of the submitting provider to submit the most ac curate and appropriate CPT/HCPCS code(s) for the product or service that is being provided. The inclusion of a code does not imply any right to reimbursement or guarantee claims payment. C. DEFINITIONS Bilateral procedures-are defined as surgical operations performed on both the right and left side of a patient’s body during the same operative session requiring separate sterile fields and a separate surgical incision. Modifier-is a reporting indicator used in conjunction with a CPT code to denote that a medical service or procedure that has been performed has been altered by a specific circumstance while remaining unchanged in its definition or CPT code. D. POLICY I. CareSource will reimburse for bilateral procedures when medically necessary. II. CareSource will reimburse for bilateral procedures when providers submit their claim with appropriate CPT/HCPCS codes and modifier. A. Modifier 50 is used to report bilateral procedures (procedures described with the same CPT code) that are performed at the same operative session by the same physician on bilateral body structures (identical anatomic sites on opposite sides of the body). The use of modifier 50 is applicable only to services and/or procedures performed on identical anatomic sites or organs (e.g., eyes, ears, kidneys). B. Modifiers LT and RT may also be used to report services rendered on identical anatomic sites; however the use of these modifiers is not interchangeable with use of modifier 50. Modifiers LT and RT should only be used when the bilateral surgery rules do not apply. The bilateral surgery rules apply to procedures with a bilateral indicator of 1 , as defined by the Centers for Medicare & Medicaid (CMS). When the fee schedule has a bilateral indicator of 0 or 3 , as defined by CMS, use modifiers LT and RT to describe procedures performed on identical anatomic sites. 1. A bilateral procedure is reported on one line using modifier 50. Use a quantity entry of one when modifier 50 is reported. Do not submit two line items to report a bilateral procedure using modifier 50. 2. Modifier 50 should not be used to report diagnostic and radiology facility services. 3. Institutional claims received for an outpatient radiology service appended with modifier 50 will be denied. III. Surgical codes that are considered bilateral codes but are performed unilaterally on only one side of the body should be billed on one line unmodified or on one line with either the LT or the RT modifier indicating the side of the body on which the procedure was performed. Archived Bilateral Procedures Ohio Med icaid PY-0012 Effective Date: 02 /0 2 /201 9 3 A. Modifiers LT or RT are required when appropriate to identify: 1. Hospital procedures performed on identical anatomic sites on the right and left sides of the body (e.g., ears, eyes, nostrils, kidneys, lungs, and ovaries). 2. A procedure is performed on only one side. 3. Hospital diagnostic test and radiology services performed on the right and left sides of the body. NOTE: Use of modifiers applies to services/procedures performed on the same calendar day. NOTE: CareSource will reimburse for bilateral procedures when the proper modifiers 50, LT, and RT are used. Modifier 50 is not to be utilized if the CPT code description specifies the procedure as bilateral. IV. Surgical codes that are considered bilateral codes but are performed more than once on one or each side of the body and/or body part indicated by the code definition must be billed using only the LT and RT modifiers on each line to demonstrate the procedure was performed more than once on one or each side. V. Although bilateral indicators 0 and 3 can be billed with the LT and RT modifiers, there are some differences between the two indicators; A. Some codes with an indicator of 0 may be performed more than once on a given day. However, even if performed on opposite sides of the body, these services would never be considered bilateral. B. Codes with an i ndicator of 0 can never be billed with modifier 50. C. Codes with an indicator of 3 can be billed with LT or RT. These services are generally radiologic and other diagnostic services. D. Codes that have an indicator of 0 that are billed using LT or RT receive reimbursement for a single code. VI. The CareSource maximum for bilateral procedures is 150% of the contracted amount allowed for the same procedures performed unilaterally when the code is billed on a single line with the 50 modifier. Bilateral Indicator Definition Submission Instructions 0 Bilateral surgery payment rules do not apply, do not use modifier 50. Do not submit these procedures with CPT modifier 50. 1 Bilateral surgery payment rules apply (150%). Use modifier 50 if bilateral. Units = 1 Submit the procedure on a single detail line with CPT modifier 50 and a quantity of 1. 2 Bilateral surgery payment rules do not apply. Already priced as bilateral. Do not use modifier 50. Units = 1 Submit the procedure with a quantity of 1. Do not submit these procedures with CPT modifier 50. 3 Bilateral surgery payment rules do not apply. Do not use modifier 50. Units = 1 or 2. Do not submit these procedures with CPT modifier 50. 9 Bilateral concept does not apply. Do not submit these procedures with CPT modifier 50. Archived Bilateral Procedures Ohio Med icaid PY-0012 Effective Date: 02 /0 2 /201 9 4 E. CONDITIONS OF COVERA GE A UTHORIZATION PERIOD F. RELATED POLICIES/RUL ES G. REVIEW/REVISION HIST ORY DATE ACTION Date Issued 07/01/2013 Date Revised 01 / 02/2019 Revision Date Effective 02/02/2019 H. REFERENCES 1. Surgical services. (2015, July 03). Retrieved August 15, 2016, from http://codes.ohio.gov/oac/5160-4 – 22 . The Reimbursement Po l i c y St a t e m e nt d e t ai l e d a bo v e h a s r ecei v e d due c on si d e ra t i o n a s d e f i n e d i n the Reimbursement Po li c y St a t e m e nt Po li c y a nd i s a pp r o v e d. Archived
REIMBURSEMENT POLICY STATEMENT OHIO MEDICAIDOriginal Issue Date Next Annual Review Effective Date 0 9/01/2017 0 9/01/2018 09/01/2017 Policy Name Policy Number Positive Airway Pressure Devices for Pulmonary Disorders PY-0313 Policy Type Medical Administrative Pharmacy REIMBURSEMENT Reimbursement Policies prepared by CSMG Co. and its affiliates (including CareSource) are intended to provide a general reference regarding billing, coding and documentation guidelines. Coding methodology, regulatory requirements, industry-standard claims editing logic , benefits design and other factors are considered in developing Reimbursement Policies. In addition to this Policy, Reimbursement of services is subject to member benefits and eligibility on the date of service, medical necessity, adherence to plan polic ies and procedures, claims editing logic, provider contractual agreement, and applicable referral, authorization, notification and utilization management guidelines. Medically necessary services include, but are not limited to, those health care services o r supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunctio n of a body organ or par t, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any federal or state coverage mandate, Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. This Policy does not ensure an authorizati on or Reimbursement of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced herein. If there is a conflict between this Policy and the plan contract ( i.e. , Evidence of Coverage), then t he plan contract ( i.e. , Evidence of Coverage) will be the controlling document used to make the determination. CSMG Co. and its affiliates may use reasonable discretion in interpreting and applying this Policy to services provided in a particular case and may modify this Policy at any time. Contents of Policy REIMBURSEMENT POLICY STATEMENT ………………………………………………………….. 1 TABLE OF CONTENTS ………………………………………….. Error! Bookmark not defined. A.SUBJECT …………………………………………………….. Error! Bookmark not defined. B.BACKGROUND ……………………………………………………………………………………….. 2 C.DEFINITIONS ………………………………………………………………………………………….. 2 D.POLICY ………………………………………………………. Error! Bookmark not defined. E.CONDITIONS OF COVERAGE ………………………………………………………………….. 3 F.RELATED POLICIES/RUL ES …………………………. Error! Bookmark not defined. G.REVIEW/REVISION HISTORY ………………………………………………………………….. 4 H.REFERENCES ………………………………………………………………………………………… 4 Archived Positive Airway Pressure Devices for Pulmonary Disorders Ohio Medicaid PY-0313 Effective Date: 09/01/2017 2 A. SUBJECT Positive Airway Pressure Devices for Pulmonary Disorders B. BACKGROUND Reimbursement policies are designed to assist you when submitting claims to CareSource. They are routinely updated to promote accurate coding and policy clarification. These proprietary policies are not a guarantee of payment. Reimbursement for claims may be subject to limitations and/or qualifications. Reimbursement will be established based upon a review of the actual services provided to a member and will be determined when the claim is received for processing. Health care providers and their office staff are encouraged to use self-service channels to verify members eligibility. It is the responsibility of the submitting provider to submit the most accurate and appropriate CPT/HCPCS code(s) for the product or service that is being provided. The inclusion of a code in this policy does not imply any right to reimbursement or guarantee claims payment. Positive airway pressure (PAP) devices, involve using a machine that includes a mask or other device that fits over the nose and/or mouth to provide positive pressure to keep breathing airways open. Continuous positive airway pressure or CPAP is used to treat sleep-related breathing disorders including sleep apnea. It also may be used to treat preterm infants who have underdeveloped lungs. Bilevel or two level positive airway pressure or BiPAP is used to treat lung disorders such as chronic obstructive pulmonary disease (COPD). While CPAP delivers a single pressure, BiPAP delivers positive pressure both on inhalation and exhalation. PAP can provide better sleep quality, reduction or elimination of snoring, and less daytime sleepiness. The PAP machines should always be used according to the physicians order as well as every time during sleep at home, while traveling, and during naps in order to produce the most effective outcome C. DEFINITIONS Medically necessary health products, supplies or services that are necessary for the diagnosis or treatment of disease, illness, or injury and meet accepted guidelines of medical practice. Adherence is the use of the device regularly as prescribed by the ordering physician. Deviation is the altered or lack of use of the device as prescribed by the ordering physician. D. POLICY I. CareSource does not require a prior authorization for the first 3 month rental on a PAP machines (CPAP/BiPAP) . A. CPAP (E0601) machines and BiPAP (E0470) are a 10 month rent to purchase. B. Prior authorization must be obtain through CareSource starting after the 3 rdmonth rental (months 4-10). C. BiPAP machines (E0471) are a continuous rental and are never cap out as a purchase II.Providers that dispense the PAP machine must ensure and document the members compliance with its use. A. CareSource considers adherence with the use of PAP as the following: 1. The member uses the device regularly as prescribed by the ordering physician. 2. If there is a discontinuation of use at any time, the PAP supplier is expected to ascertain adherence and stop billing for the equipment, related accessories and supplies. Archived Positive Airway Pressure Devices for Pulmonary Disorders Ohio Medicaid PY-0313 Effective Date: 09/01/2017 3 3. The member has follow-up appointments with the ordering physician to determine effectiveness and that documentation is keep on file with the supplier and will be made available upon request by CareSource if needed. III. When lack of adherence or deviation from the ordered use of a PAP machine is confirmed, the PAP machine, further rental and providers claims will be denied. A. Any reimbursement that was dispersed during the time of deviation will be recouped by CareSource. B. Any supplies that were dispensed during the time of deviation will be recouped by CareSource. Note:Although CareSource does not require a prior authorization during the first 3 months of use, CareSource may request documentation to support medical necessity that shows adherence to the ordered use of the PAP machine. Appropriate and complete documentation must be presented at the time of review to validate medical necessity. E.CONDITIONS OF COVERA GE Reimbursement is dependent on, but not limited to, submitting Ohio Medicaid approved HCPCS and CPT codes along with appropriate modifiers. Please refer to the Ohio Medicaid fee schedule http://codes.ohio.gov/pdf/oh/admin/2016/5160-10-03_ph_ff_a_app2_20160321_1242.pdf The following PDF list(s) of codes is provided as a reference. This list may not be all inclusive and is subject to updates. Please refer to the above referenced source for the most current coding information. Code Description A4604 Tubing with integrated heating element for use with positive airway pressure device A7030 Full face mask used with positive airway pressure device A7031 Face mask interface, replacement for full face mask A7032 Cushion for use on nasal mask interface, r eplacement only A7033 Pillow for use on nasal cannula type interface, replacement only, pair A7034 Nasal interface (mask or cannula type) used with positive airway pressure device, with or without head strap A7035 Headgear used with positive airway pressure device A7037 Tubing used with positive airway pressure device A7038 Filter, disposable, used with positive airway pressure device A7039 Filter, non-disposable, used with positive airway pressure device E0470 Respiratory assist device, bi-level pressure capability, without backup rate feature E0471 Respiratory assist device, bi-level pressure capability, with back-up rate feature E0472 Respiratory assist device, bi-level pressure capability, with backup rate feature, used with invasive interfa ce E0601 Continuous positive airway pressure (CPAP) device F. RELATED POLICIES/RUL ES MCG Ambulatory Care 20 thEdition ACG: A-0337 CPAP Titration, Home (APAP) MCG Ambulatory Care 20 thEdition ACG: A-0338 CPAP Titration, Sleep Center MCG Ambulatory Care 20th Edition ACG: A-0431 Noninvasive Positive Pressure Ventilation (CPAP, BiPAP) ArchivedPositive Airway Pressure Devices for Pulmonary Disorders Ohio Medicaid PY-0313 Effective Date: 09/01/2017 4 G.REVIEW/REVISION HISTORY DATE ACTION Date Issued 0 9/01/2017 Date Revised Date Effective 09/01/2017 H.REFERENCES1. CPAP-NHLBI, NIH. (2016, December 9). Retrieved 5/8/2017 from https://www.nhlbi.nih.gov/health/health-topics/topics/cpap/ 2. CPAP vs BiPAP-American Sleep Association. (2017). Retrieved 5/21/2017 from https://www.sleepassociation.org/cpap-vs-bipap/ 3. Lawriter-OAC-5160-10-22 Volume ventilators, positive and negative pressure ventilators,continuous positive airway pressure (CPAP), alternating positive airway pressure (APAP),and intermittent positive pressure ventilation (IPPV). (2013, January 1). Retrieved 5/8/2017from http://codes.ohio.gov/oac/5160-10-22 The Reimbursement Policy Stateme nt detai led above has received due con side ration as defined in the Reimbursement Po licy Stateme nt Po licy a nd is a pprove d. OH-P-1343Archived
REIMBURSEMENT POLICY STATEMENT OHIO MEDICAID Original Issue Date Next Annual Review Effective Date 07/01/2017 04/04/2018 07/01/2017 Policy Name Policy Number Lipid Testing Assessing Cardiovascular Risk PY-0 255 Policy Type Medical Administrative Pharmacy REIMBURSEMENT Reimbursement Policies prepared by CSMG Co. and its affiliates (including CareSource) are intended to provide a general reference regarding billing, coding and documentation guidelines. Coding methodology, regulatory requirements, industry-standard claims editing logic, benefits design and other factors are considered in developing Reimbursement Policies. In addition to this Policy, Reimbursement of services is subject to member benefits and eligibility on the date of service, medical necessity, adherence to plan policies and procedures, claims editing logic, provider contractual agreement, and applicable re ferral, authorization, notification and utilization mana gement guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expecte d to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternati ve, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any federal or state coverage mandate, Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. This Policy does not ensure an authorization or Reimbursement of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced h erein. If there is a conflict between this Policy and the plan contract ( i.e. , Evidence of Coverage), then the plan contract ( i.e. , Evidence of Coverage) will be the controlling document used to make the determination. CSMG Co. and its affiliates may u se reasonable discretion in interpreting and applying this Policy to services provided in a particular case and may modify this Policy at any time. Contents of Policy REIMBURSEMENT POLICY STATEMENT ………………………………………………………….. 1 TABLE OF CONTENTS …………………………………………………………………………………… .. 1 A.SUBJECT ……………………………………………………………………………………………….. 2 B.BACKGROUND ……………………………………………………………………………………….. 2 C.DEFINITIONS ………………………………………………………………………………………….. 2 D.POLICY …………………………………………………………………………………………………. 3 E.CONDITIONS OF COVERA GE ………………………………………………………………….. 4 F.RELATED POLICIES/RUL ES ……………………………………………………………………. 5 G.REVIEW/REVISION HISTORY ………………………….. ……………………………………… 5 H.REFERENCES ………………………………………………………………………………………… 5Archived Lipid Testing Assessing Cardiovascular Risk Ohio Medicaid PY-0255 Effective Date:07/01/2017 2 A.SUBJECT Lipid Testing Assessing Cardiovascular Risk B. BACKGROUND Reimbursement policies are designed to assist you when submitting claims to CareSource. They are routinely updated to promote accurate coding and policy clarification. These proprietary policies are not a guarantee of payment. Reimbursement for claims may be subject to limitations and/or qualifications. Reimbursement will be established based upon a review of the actual services provided to a member and will be determined when the claim is received for processing. Health care providers and their office staff are encouraged to use self-service channels to verify members eligibility. It is the responsibility of the submitting provider to submit the most accurate and appropriate CPT/HCPCS code(s) for the product or service that is being provided. The inclusion of a code in this policy does not imply any right to reimbursement or guarantee claims payment. Cardiovascular disease (CVD) is one of the leading causes of morbidity and mortality in the United States. Vascular disease is the major contributor to CVD events. High levels of cholesterol in the blood, increase a persons risk of developing CVD . Total cholesterol levels include all the cholesterol found in various lipoproteins. Lipoproteins vary in size and density and include cholesterol esters and free cholesterol, triglycerides, phospholipids and A, C, and Eapoproteins. Blood levels of total cholesterol and various fractions of cholesterol, especially low density lipoproteins (LDL) and high density lipoproteins (HDL), are useful in assessing and monitoring treatment for that risk in patients with cardiovascular and related diseases. Lipid testing is used to indicate the chances of having cardiovascular disease (CVD) and/or of having a coronary event. C. DEFINITIONS Medically necessary health products, supplies or services that are necessary for the diagnosis or treatment of disease, illness, or injury and meet accepted guidelines of medical practice. Cholesterol-White, crystalline substance found in animal tissues and various foods that is normally synthesized by the liver and is important as a constituent of cell membrane and a precursor to steroid hormones; its level in the bloodstream can influence the pathogenesis of certain conditions, such as the development of atherosclerotic plaque and coronary artery disease. Coronary Heart Disease (CHD) – Any heart disorder caused by disease of the coronary arteries. High Density Lipoprotein (HDL) – A lipoprotein that transports cholesterol in the blood; composed of a high proportion of protein and relatively little cholesterol. High levels are thought to be associated with decreased risk of CHD and atherosclerosis. High-sensitivity C-reactive protein (hs-CRP) – A protein produced in the liver that is a marker of inflammation. Immunoassay-Any laboratory method for detecting a substance by using an antibody reactive with it. Lipid-Oily organic compound insoluble in water but soluble in organic solvents; essential structural component of living cells (along with proteins and carbohydrates). Low Density Lipoprotein (LDL) – A lipoprotein that transports cholesterol in the blood; composed of a moderate amount of protein and a large amount of cholesterol. High levels ar e thought to be associated with increased risk of CHD and atherosclerosis. Peripheral Arterial Disease (PAD) – A narrowing of the vessels that carry blood to the legs, arms, abdomen or kidneys; also known as peripheral vascular disease (PVD). ArchivedLipid Testing Assessing Cardiovascular Risk Ohio Medicaid PY-0255 Effective Date:07/01/2017 3 Plaque-Deposit of fatty material on the inner lining of an arterial wall; characteristic of atherosclerosis. Triglyceride Naturally occurring ester (compound) of three fatty acids and glycerol that is the chief constituent of fats and oils. Unsaturated-Ca pable of taking up, or of uniting with, certain other elements or compounds, without the elimination of any side. D. POLICY I. CareSource members may receive lipid testing without prior authorization. Lipid testing must be medically necessary. II. Conditions in which lipid testing may be indicated include: A.Assessment of patients with atherosc lerotic cardiovascular disease. B. Evaluation of primary dyslipidemia. C. Any form of atherosclerotic disease, or any disease leading to the form ation of atherosclerotic disease.D. Diagnostic evaluation of diseases associated with altered lipid metabolism, such as: nephrotic syndrome, pancreatitis, hepatic disease, and hypo and hyperthyroidism.E. Secondary dyslipidemia, including diabetes mel litus, disorders of gastrointestinal absorption, chronic renal failure.F. Signs or symptoms of dysli pidemias, such as skin lesions. G. As follow-up to the initial screen for coronary heart disease (total cholesterol + HDL cholesterol) when total chole sterol is determined to be high (>240 mg/dL), or borderline-high (200-240 mg/dL) plus two or more coronary heart disease risk factors, or an HDL cholesterol,
REIMBURSEMENT POLICY STATEMENT OHIO MEDICAID Original Effective Date Next Annual Review Effective Date 08/10/2016 05/15/2018 05/26 /2017 Policy Name Policy Number Sexually Transmitted Infections PY-00 37 Policy Type Medical Administrative Pharmacy RE IMBURSEMENT Reimbursement Policies prepared by CSMG Co. and its affiliates (including CareSource) are intended to provide a general reference regarding billing, coding and documentation guidelines. Coding methodology, regulatory requirements, industry-st andard claims editing logic, benefits design and other factors are considered in developing Reimbursement Policies. In addition to this Policy, Reimbursement of services is subject to member benefits and eligibility on the date of service, m edical necessi ty, adherence to plan policies and procedures, claims editing logic, provider contractual agreement, and applicable referral, authorization, notification and utilization management guidelines. Medically necessary services include, but are not limited to, t hose health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunc tion of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Me dically necessary services also include those services defined in any federal or state coverage mandate, Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. This Policy doe s not ensure an authorization or Reimbursement of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced herein. If there is a conflict between this Policy and the plan contract ( i.e. , Ev idence of Coverage), then the plan contract ( i.e. , Evidence of Coverage) will be the controlling document used to make the determination. CSMG Co. and its affiliates may use reasonable discretion in interpreting and applying this Policy to services prov ided in a particular case and may modify this Policy at any time. Contents of Policy REIMBURSEMENT POLICY STATEMENT ………………………………………………………….. 1 TABLE OF CONTENTS …………………………………………………………………………………… .. 1 A.SUBJECT ……………………………………………………………………………………………….. 2 B.BACKGROUND ……………………………………………………………………………………….. 2 C.DEFINITIONS ………………………………………………………………………………………….. 3 D.POLICY …………………………………………………………………………………………………. 3 E.CONDITIONS OF COVERA GE ………………………………………………………………….. 4 F.RELATED POLICIES/RULES ………………………………………………………………….. 11 G.REVIEW/REVISION HISTORY ………………………….. ……………………………………. 11 H.REFERENCES ………………………………………………………………………………………. 11Archived Sexually Transmitted Infections OHIO Medicaid PY-0037 Effective Date: 05/26/17 2 A. SUBJECT Sexually Transmitted Infections (STI) Screening B. BACKGROUND Reimbursement policies are designed to assist you when submitting claims to CareSource. They are routinely updated to promote accurate coding and policy clarification. These proprietary policies are not a guarantee of payment. Reimbursement for claims may be subject to limitations and/or qualifications. Reimbursement will be established based upon a review of the actual services provided to a member and will be determined when the claim is received for processing. Health care providers and their office staff are encouraged to use self-service channels to verify members eligibility. It is the responsibility of the submitting provider to submit the most accurate and appropriate CPT/HCPCS code(s) for the product or service that is being provided. The inclusion of a code does not imply any right to reimbursement or guarantee claims payment. Sexually transmitted infections (STIs) cause significant morbidity and mortality in the United States each year. The United States Preventive Services Task Force (USPSTF) recommends that women at increased risk of infection be screened for chlamydia, gonorrhea, human immunodeficiency virus, and syphilis. Men at increased risk should be screened for human immunodeficiency virus and syphilis. All pregnant women should be screened for hepatitis B, human immunodeficiency virus, and syphilis; pregnant women at increased risk also should be screened for chlamydia and gonorrhea. Non-pregnant women and men not at increased risk do not require routine screening for sexually transmitted infections. Engaging in high-risk sexual behavior places persons at increased risk of sexually transmitted infections. The USPSTF recommends that all sexually active women younger than 25 years be considered at increased risk of chlamydia and gonorrhea. [1] Because not all communities present equal risk of sexually transmitted infections, the USPSTF, the US Centers for Disease Control (CDC), t h e A m e r i c a n Co l l e g e o f Ob s t e t r i c i a n s a n d Gy n e c o l o g i s t s ( A CO G ) a n d o t h e r a u t h o r i t i e s encourage physicians to consider expanding or limiting the routine sexually transmitted infection screening they provide based on the community and populations they serve. [2-8] Historically, intervention efforts have focused on individual-level factors associated with STD risk. For example, It is important to educate members to practice safer sex, and for providers to screen high-risk individuals for common STIs. Investigators are now also evaluating higher-level factors (e.g., peer norms. media influences, and other social and cultural factors) which may also influence behaviors. [9] Until effective strategies involving higher-level factors emerge, matching individual factors to screening test indications is the mainstay of STI screening. Generally, a recommendation for screening is based upon the strength of evidence that acting upon results of a screening test will lead to a significantly decreased infection rate for the target population evaluated. CareSource encourages screening for Sexually Transmitted Infections consistent with the grade A and Brecommendations of the USPSTF and the Centers for Medicare & Medicaid (CMS) National Coverage Determination (NCD) Policy 210.10 for Screening for Sexually Transmitted Infections. In addition to these recommendations, CareSource encourages screening for Sexually Transmitted Infections for men at increased risk. CareSource has eliminated the annual screen limitations set forth in the NCD as well as the order of billing STI diagnosis codes. The specific rules that apply for diagnosis codes (for Medicaid members only ) are outlined in this policy. ArchivedSexually Transmitted Infections OHIO Medicaid PY-0037 Effective Date: 05/26/17 3 C. DEFINITIONS Sexually transmitted infections (STI) – are infections that are passed from one person to another through sexual contact. Nucleic acid amplification tests (NAATs) are gene amplification laboratory tests such as polymerase chain reaction (PCR) that are cleared by the United States Food and Drug Administration (FDA) and are recommended for detection of genital tract infections caused by Chlamydia trachomatis and Neisseria gonorrhoeae with or without symptoms. For detecting these infections of the genital tract, optimal specimen types for NAATs are vaginal swabs from women and first catch urine from men. Older nonculture tests and non-NAATs have inferior sensitivity and specificity characteristics and no longer are recommended. Since 2002, improvements in chlamydia and gonorrhea NAAT technologies have enabled significant implementation and expansion of screening programs using less invasive specimen collection. [5] High risk behaviors for acquiring a sexually transmitted disease are considered in the med ical history of a clinical evaluation. Many STIs are asymptomatic, but without detection by appropriate screening evaluation may lead to morbidity or preterm labor in pregnant women [7] 1. Early sexual activity, for example before age 18. 2. Multiple sex partners. 3. Sex with a high-risk partner (one who has multiple sex partners or other risk factors). 4. Unprotected intercourse without consistent or correct male or female condom use, except in a long-term, single-partner (monogamous) relationship. 5. Unprotected mouth-to-genital contact, except in a long-term monogamous relationship. 6. Having anal sex or a partner who does, except in a long-term, single-partner (monogamous) relationship. 7. Having sex with a partner who injects or has ever injected drugs. 8. Exchange of sex (sex work) for drugs or money. 9. Having had Chlamydia trachomatis or other sexually transmitted diseases in the past. D. POLICY I.Prior authorization is not required for any medically necessary STI screenings. NOTE: Although the drug screenings covered by this policy do not require a prior authorization, CareSource may request documentation to support medical necessity. Appropriate and complete documentation must be presented at the time of review to validate medical necessity. II.Screening tests for the STIs referred to in this policy are selected laboratory tests. Materia l related to diagnostic testing in this policy is included to clarify coverage for diagnostic versus screening indications. III. Sexually Transmitted Infections (STI) Screening: Chlamydia and Gonorrhea A. CareSource considers screening for Chlamydia trachomatis (Chlamydia) and Neisseria gonorrhea (Gonorrhea) infections as medically necessary preventive care for these member groups according to the USPSTF, CDC, and NCQA: 1. All pregnant women younger than 25 years of age 2. All sexually active women younger than 25 years of age 3. Men and women with high-risk factors of any age for Chlamydia trachomatis and/or Gonorrhea infection . B. In agreement with the USPSTF, CareSource considers Chlamydia and Gonorrhea screening experimental and investigational for asymptomatic low risk men, and for women who do not meet the above criteria, because of insufficient evidence in the peer-reviewed literature for low-risk populations. Archived Sexually Transmitted Infections OHIO Medicaid PY-0037 Effective Date: 05/26/17 4 C. Routine repeat testing of NAAT-positive genital tract specimens is not recommended because the practice does not improve the positive predictive value of the test. IV. Sexually Transmitted Infections (STI) Diagnosis: Chlamydia and Gonorrhea A. CareSource considers Chlamydia and/or Gonorrhea diagnostic testing medically necessary for members with signs or symptoms of Chlamydia and/or Gonorrhea infection. B. CareSource considers home testing for Chlamydia and/or Gonorrhea experimental and investigational because of insufficient evidence in the peer-reviewed literature. V. Sexually Transmitted I nfections (STI) Screening: Trichomoniasis/Trichomonas vaginalis A. CareSource provides coverage for screening test for Trichomoniasis in high risk men, and Trichomoniasis/trichomonas vaginalis in high risk women, pregnant women, and women under 25.[7] B. The screening of asymptomatic pregnant women for bacterial vaginosis to reduce the lik elihood of pre-term birth is considered experimental and investigational and is not covered by the American College of Obstetricians and Gynecologists. [3] C. CareSource considers screening as medically necessary for Trichomoniasis in men with high risk factors, and Trichomoniasis/Trichomonas vaginalis in women with high risk factors. D. Culture is a sensitive and highly specific commercially available method of diagnosis. Among women in whom trichomoniasis is suspected but not confirmed by microscopy, vaginal secretions should be cultured for T. vaginalis . E. An FDA-cleared PCR assay for detection of gonorrhea and chlamydial infection (Amplicor, Roche Diagnostic Corp.) has been modified for T. vaginalis detection in vaginal or endocervical swabs and in urine from women and men; sensitivity ranges from 88% 97% and specificity from 98% 99% .[10] APTIMA T. vaginalis Analyte Specific Reagents (ASR, Gen-Probe, Inc.) also can detect T. vaginalis RNA by transcription-mediated amplification using the same instrumentation platforms available for the FDA-cleared APTIMA Combo2 assay for diagnosis of gonorrhea and chlamydial infection; published validation studies of T. vaginalis ASR found sensitivity ranging from 74% 98% and specificity of 87% 98%.[11] E. CONDITIONS OF COVERA GE Reimbursement is dependent on, but not limited to, submitting Ohio Medicaid approved HCPCS and CPT codes along with appropriate modifiers. Please refer to the Ohio Medicaid fee schedule. http://medicaid.ohio.gov/Portals/0/Providers/FeeScheduleRates/App-DD.pdf The following list(s) of codes is provided as a reference. This list may not be all inclusive and is subject to updates. Please refer to the above referenced source for the most current coding information.I.Coverage-General A. CareSource will cover screening for these USPSTF-indicated STIs with the appropriate Food and Drug Adm inistration (FDA)-approved/cleared laboratory tests when ordered and performed by an eligible provider for these services, and when used consistent with FDA-approved labeling and in compliance with the Clinical Laboratory Improvement Act (CLIA) regulat ions. B. High-Intensity Behavioral Counseling (HIBC) to prevent STIs may be provided on the same date of services as an annual wellness visit, evaluation and management (E&M) service, or during the global billing period for obstetrical care, but only one HIBC may be provided on any one date of service. Archived Sexually Transmitted Infections OHIO Medicaid PY-0037 Effective Date: 05/26/17 5 II.Covered Screening Tests for Asymptomatic Members A. If policy criteria are met, CareSource will reimburse for the following CPT codes once per calendar year for screening when medically necessary to test f or sexually transmitted infections (STIs) in asymptomatic men and women if accompanied by one or more of the following gender-appropriate ICD-10 codes: B. If policy criteria are met, CareSource will reimburse for the above CPT codes when medically necessary to test for sexually transmitted infections (STIs) in asymptomatic men and women if accompanied by one or more of the following gender-appropriate ICD-10 codes: Z00.01 Encounter for general adul t medical examination with abnormal findings Z20 Contact with and (suspected) exposure to communicable diseases Z20.2 Contact with and (suspected) exposure to infections with a predominantly sexual mode of transmission Z20.8 Contact with and (suspec ted) exposure to other communicable diseases Z20.818 Contact with and (suspected) exposure to other bacterial communicable diseases Z20.89 Contact with and (suspected) exposure to other communicable diseases Z20.9 Contact with and (suspected) expos ure to unspecified communicable disease Z22.4 Carrier of infections with a predominantly sexual mode of transmission Z72.51-Z72.53 High-risk sexual behavior Codes Description 87491 Infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis , amplified probe technique 87591 Infectious agent detection by nucleic acid (DNA or RNA); Neisseria gonorrhoeae, amplified probe technique 87661 Infectious agent detection by nucleic acid (DNA or RNA); Trichomonas vaginalis, amplified probe technique Z 00 Encounter for general examination without complaint, suspected or reported diagnosis Z00.0 Encounter for general adult medical examination Z00.3 Encounter for examination for adolescent development state Z00.8 Encounter for other general examinat ion Z01.419 Encounter for gynecological examination (general) (routine) without abnormal findings Z11.3 Encounter for screening for infections with a predominantly sexual mode of transmission Z11.8 Encounter for screening for other infectious and pa rasitic diseases [chlamydia] Z34 Encounter for supervision of normal pregnancy Z71 Persons encountering health services for other counseling and medical advice, not elsewhere classified Codes Description ArchivedSexually Transmitted Infections OHIO Medicaid PY-0037 Effective Date: 05/26/17 6 O09 O09.A3 Supervision of high-risk pregnancy III.Covered Screening Tests for Symptomatic Members A. Chlamydia. If policy criteria are met, CareSource will reimburse for the following CPT codes for diagnosis when medically necessary to test for sexually transmitted infections (STIs) if accompanied by one or more of the following gender-appropri ate ICD-10 codes: Codes Description 86631 Antibody; Chlamydia 86632 Antibody; Chlamydia,Igm 87110 Culture, Chlamydia 87270 Chlamydia trachomatis antigen detection by DFA 87320 Chlamydia trachomatis antigen detection by EIA 87490 Chlamydia trachomat is detect by DNA, dir. probe 87491 Infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis, amplified probe technique 87810 Chlamydia trachomatis detect by immunoassay 87800 Detect agent mult i , DNA , direct A55 Chlamydial lymphog ranuloma (venereum) A56 Other sexually transmitted chlamydial diseases A56.0 Chlamydial infection of lower genitourinary tract A56.00 Chlamydial infection of lower genitourinary tract, unspecified A56.01 Chlamydial cystitis and urethritis A56. 02 Chlamydial vulvovaginitis A56.09 Other chlamydial infection of lower genitourinary tract A56.1 Chlamydial infection of pelviperitoneum and other genitourinary organs A56.11 Chlamydial female pelvic inflammatory disease A56.19 Other chlamydia l genitourinary infection A56.2 Chlamydial infection of genitourinary tract, unspecified A56.3 Chlamydial infection of anus and rectum A56.4 Chlamydial infection of pharynx A56.8 Sexually transmitted chlamydial infection of other sites A74 Other diseases caused by chlamydiae A74.0 Chlamydial conjunctivitis A74.8 Other chlamydial diseases A74.81 Chlamydial peritonitis A74.89 Other chlamydial diseases A74.9 Chlamydial infection, unspecified N71.0 Acute inflammatory disease of u terus N71.1 Chronic inflammatory disease of uterus N71.9 Inflammatory disease of uterus, unspecified N72 Inflammatory disease of cervix uteri N73 Other female pelvic inflammatory diseases N73.0 Acute parametritis and pelvic cellulitis N73.1 Chronic parametritis and pelvic cellulitis N73.2 Unspecified parametritis and pelvic cellulitis N73.3 Female acute pelvic peritonitis N73.4 Female chronic pelvic peritonitis N73.5 Female pelvic peritonitis, unspecified ArchivedSexually Transmitted Infections OHIO Medicaid PY-0037 Effective Date: 05/26/17 7 N73.6 Female pelvic peritoneal adh esions (post infective) N73.8 Other specified female pelvic inflammatory diseases N73.9 Female pelvic inflammatory disease, unspecified N74 Female pelvic inflammatory disorders in diseases classified elsewhere N76 Other inflammation of vagina and vulva N76.0 Acute Vaginitis N76.1 Subacute and chronic vaginitis N76.2 Acute vulvitis N76.3 Subacute and chronic vulvitis N76.4 Abscess of vulva N76.5 Ulceration of vagina N76.6 Ulceration of vulva N76.8 Other specified inflammation of vagina and vulva N76.81 Mucositis (ulcerative) of vagina and vulva N76.89 Other specified inflammation of vagina and vulva N34 Urethritis N34.0 Urethral abscess N34.1 Nonspecific urethritis N34.2 Other urethritis N34.3 Urethral syndrome, unspecified O98 Maternal infectious and parasitic diseases classifiable elsewhere but complicating pregnancy, childbirth and the puerperium B. Gonorrhea .If policy criteria are met, CareSource will reimburse for the following CPT codes for diagnosis when medically necessary to test for sexually transmitted infections (STIs) if accompanied by one or more of the following gender-appropriate ICD-10 codes: Code Description 87590 N. gonorrhoeae by DNA, direct probe 87591 Infectious agent detection by nucleic acid (DNA or RNA) ; Neisseria gonorrhoeae, amplified probe technique 87850 N. gonorrhoeae detection by immunoassay 87800 Detect agent mult i , DNA , direct A54 Gonococcal infection A54.0 Gonococcal infection of lower genitourinary tract without periurethral or accessory g land abscess A54.00 Gonococcal infection of lower genitourinary tract, unspecified A54.01 Gonococcal cystitis and urethritis, unspecified A54.02 Gonococcal vulvovaginitis, unspecified A54.03 Gonococcal cervicitis, unspecified A54.09 Other gonoc occal infection of lower genitourinary tract A54.1 Gonococcal infection of lower genitourinary tract with periurethral and accessory gland abscess A54.2 Gonococcal pelviperitonitis and other gonococcal genitourinary infection A54.21 Gonococcal inf ection of kidney and ureter A54.22 Gonococcal prostatitis A54.23 Gonococcal infection of other male genital organs A54.24 Gonococcal female pelvic inflammatory disease ArchivedSexually Transmitted Infections OHIO Medicaid PY-0037 Effective Date: 05/26/17 8 A54.29 Other gonococcal genitourinary infections A54.3 Gonococcal infectio n of eye A54.30 Gonococcal infection of eye, unspecified A54.31 Gonococcal conjunctivitis A54.32 Gonococcal iridocyclitis A54.33 Gonococcal keratitis A54.39 Other gonococcal eye infection A54.4 Gonococcal infection of musculoskeletal system A54.40 Gonococcal infection of musculoskeletal system, unspecified A54.41 Gonococcal spondylopathy A54.42 Gonococcal arthritis A54.43 Gonococcal osteomyelitis A54.49 Gonococcal infection of other musculoskeletal tissue A54.5 Gonococcal ph aryngitis A54.6 Gonococcal infection of anus and rectum A54.8 Other gonococcal infections A54.81 Gonococcal meningitis A54.82 Gonococcal brain abscess A54.83 Gonococcal heart infection A54.84 Gonococcal pneumonia A54.85 Gonococcal perit onitis A54.86 Gonococcal sepsis A54.89 Other gonococcal infections A54.9 Gonococcal infection, unspecified N71.0 Acute inflammatory disease of uterus N71.1 Chronic inflammatory disease of uterus N71.9 Inflammatory disease of uterus, unspecified N72 Inflammatory disease of cervix uteri N73 Other female pelvic inflammatory diseases N73.0 Acute parametritis and pelvic cellulitis N73.1 Chronic parametritis and pelvic cellulitis N73.2 Unspecified parametritis and pelvic cellulitis N73.3 Fema le acute pelvic peritonitis N73.4 Female chronic pelvic peritonitis N73.5 Female pelvic peritonitis, unspecified N73.6 Female pelvic peritoneal adhesions (post infective) N73.8 Other specified female pelvic inflammatory diseases N73.9 Fem ale pelvic inflammatory disease, unspecified N74 Female pelvic inflammatory disorders in diseases classified elsewhere N76 Other inflammation of vagina and vulva N76.0 Acute Vaginitis N76.1 Subacute and chronic vaginitis N76.2 Acute vulvitis N76.3 Subacute and chronic vulvitis N76.4 Abscess of vulva N76.5 Ulceration of vagina N76.6 Ulceration of vulva N76.8 Other specified inflammation of vagina and vulva N76.81 Mucositis (ulcerative) of vagina and vulva N76.89 Other specified inflammation of vagina and vulva N34 Urethritis N34.0 Urethral abscess Archived Sexually Transmitted Infections OHIO Medicaid PY-0037 Effective Date: 05/26/17 9 N34.1 Nonspecific urethritis N34.2 Other urethritis N34.3 Urethral syndrome, unspecified O98 Maternal infectious and parasitic diseases classifiable elsewhere but complicating pregnancy, chil dbirth and the puerperium C. Trichomoniasis/Trichomonas vaginalis .If policy criteria are met, CareSource will reimburse for the following CPT codes for diagnosis when medically necessary to test for sexually transmitted infections (STIs) if accompanied by one or more of the following gender-appropriate ICD-10 codes: Codes Description 87661 Infectious agent detection by nucleic acid (DNA or RNA); Trichomonas vaginalis, amplified probe technique A59 Trichomoniasis A59.9 Trichomoniasis, unspecified A59 .00 Urogenital trichomoniasis, unspecified A59.01 Trichomonal vulvovaginitis A59.02 Trichomonal prostatitis A59.03 Trichomonal cystitis and urethritis A59.09 Other urogenital trichomoniasis A59.8 Trichomoniasis of other sites A59.9 Trichomoniasis, un specified N71 Acute inflammatory disease of uterus N71.1 Chronic inflammatory disease of uterus N71.9 Inflammatory disease of uterus, unspecified N72 Inflammatory disease of cervix uteri N73 Other female pelvic inflammatory diseases N73.0 Acute param etritis and pelvic cellulitis N73.1 Chronic parametritis and pelvic cellulitis N73.2 Unspecified parametritis and pelvic cellulitis N73.3 Female acute pelvic peritonitis N73.4 Female chronic pelvic peritonitis N73.5 Female pelvic peritonitis, u nspecified N73.6 Female pelvic peritoneal adhesions (post infective) N73.8 Other specified female pelvic inflammatory diseases N73.9 Female pelvic inflammatory disease, unspecified N74 Female pelvic inflammatory disorders in diseases classified e lsewhere N76 Other inflammation of vagina and vulva N76.0 Acute Vaginitis N76.1 Subacute and chronic vaginitis N76.2 Acute vulvitis N76.3 Subacute and chronic vulvitis N76.4 Abscess of vulva N76.5 Ulceration of vagina N76.6 Ulceration of vulva N7 6.8 Other specified inflammation of vagina and vulva N76.81 Mucositis (ulcerative) of vagina and vulva N76.89 Other specified inflammation of vagina and vulva N34 Urethritis ArchivedSexually Transmitted Infections OHIO Medicaid PY-0037 Effective Date: 05/26/17 10N34.0 Urethral abscess N34.1 Nonspecific urethritis N34.2 Other urethritis N34.3 Urethral syndrome, unspecified O98 Maternal infectious and parasitic diseases classifiable elsewhere but complicating pregnancy, childbirth and the puerperium D. Syphilis .If policy criteria are met, CareSource will reimburse for the following CPT codes for diagnosis when medically necessary to test for sexually transmitted infections (STIs) if accompanied by one or more of the following ICD-10 codes: Codes Description 86592 Syphilis test non-Trep Qual 86593 Syphilis test non-Trep Quant 86780 Treponema pallidum A50 A 50.9 Congenital syphilis A51 A51.9 Early syphilis A52 A52.9 Late syphilis A53 A53.9 Other and unspecified syphilis A65 Nonvenereal syphilis E.Hepatitis B .If policy criteria are met, CareSource will reimburse for the following CPT codes for diagnosis when medically necessary to test for sexually transmitted infections (STIs) in women if accompanied by one or more of the following ICD-10 codes: Codes Description 87340 Hepatitis Bsurface antigen detection by EIA 87341 Hepatitis Bsurface, ag, EIA B16 B16.9 Acute hepatitis BB17 B17.9 Other acute viral hepatitis B18 B18.9 Chronic viral hepatitis B19 B19.9 Unspecified viral hepatitis IV. Non-Covered Services A. The US CDC notes that current guidelines do not support PCR testing for bacterial vaginosis or vaginal discharge. t orkowski et al state that “PCR also has been used in research settings for the detection of a variety of organisms associated with BV, but evaluation of its clinical utility is uncertain.”[7] The CDC does not indicate any role for PCR tests in the assessment of vaginal discharge without suspicion for C. trachomatis or N. gonorrhoeae based on history of sexual activity and presence of mucopurulent cervicitis. Otherwise, the cause of vaginal infection can be evaluated and diagnosed by pH and microscopic examination of the discharge. B37.0-B37.9 Candidiasis N76.0-N76.3 Acute, subacute, chronic vaginitis and vulvitis [bacterial vaginosis associated bacteria 2 (BVAB2), megasphaera type 2] Codes Description ArchivedSexually Transmitted Infections OHIO Medicaid PY-0037 Effective Date: 05/26/17 11N77.1 Vaginitis, vulvitis and vulvovaginitis in diseases cla ssified elsewhere [bacterial vaginosis associated bacteria 2 (BVAB2), megasphaera type 2] AUTHORIZATION PERIOD F. RELATED POLICIES/RUL ES 1. Centers for Medicare & Medicaid Services Manual Pub. 100-3 National Coverage Determination / 210.10 Screening for Sexually Transmitted Infections (STIs) and High-Intensity Behavioral Counseling (HIBC) to Prevent STIs 2. United States Preventive Services Task Force Recommendations G. REVIEW/REVISION HISTORY DATE ACTION Date Issued 08/10/2016 Date Revised 0 5/26/2017 Date Effectiv e 05/26 /2017 H. REFERENCES 1. H. D. Nelson, B. Zakher, A. Cantor, M. Deagas, and M. Pappas, “Screening for Gonorrhea and Chlamydia: Systematic Review to Update the U.S. Preventive Services Task Force Recommendations. Evidence Synthesis No. 115. AHRQ Publication No. 13-05184-EF-1,” Rockville, MD, 2014. 2. J. A. Conry and H. Brown, “Well-Woman Task Force: Components of the Well-Woman Visit,” Obstet Gynecol, vol. 126, pp. 697-701, Oct 2015. 3. ACOG, “ACOG Practice Bulletin No. 31: Assessment of Risk Factors for Preterm Birth,” Obstetrics & Gynecology, vol. 98, pp. 709-716, 2001. 4. ACOG, “ACOG Committee Opinion no. 598: Committee on Adolescent Health Care: The initial reproductive health visit,” Obstet Gynecol, vol. 123, pp. 1143-7, May 2014. 5. CDC, “Recommendations for the laboratory-based detection of Chlamydia trachomatis and Neisseria gonorrhoeae –2014,” MMWR Recomm Rep, vol. 63, pp. 1-19, Mar 14 2014. 6. H. Weinstock, S. Berman, and W. Cates, Jr., “Sexually transmitted diseases among American youth: incidence and prevalence estimates, 2000,” Perspect Sex Reprod Health, vol. 36, pp. 6-10, Jan-Feb 2004. 7. K. A. Workowski, S. Berman, C. Centers for Disease, and Prevention, “Sexually transmitted diseases treatment guidelines, 2010,” MMWR Recomm Rep, vol. 59, pp. 1-110, Dec 17 2010. 8. CDC. (2011), (Retrieved July 24, 2016). STDs Adolescents and Young Adults. . Available: at http://www.cdc.gov/std/stats11/adol.htm 9. D. M. Upchurch, W. M. Mason, Y. Kusunoki, and M. J. Kriechbaum, “Social and behavioral determinants of self-reported STD among adolescents,” Perspect Sex Reprod Health, vol. 36, pp. 276-87, Nov-Dec 2004. 1 0. B. Van Der Pol, C. S. Kraft, and J. A. Williams, “Use of an adaptation of a commercially available PCR assay aimed at diagnosis of chlamydia and gonorrhea to detect Trichomonas vaginalis in urogenital specimens,” JClin Microbiol, vol. 44, pp. 366-73, Feb 2006. 11. M. B. Nye, J. R. Schwebke, and B. A. Body, “Comparison of APTIMA Trichomonas vaginalis transcription-mediated amplification to wet mount microscopy, culture, and polymerase chain reaction for diagnosis of trichomoniasis in men and women,” Am JObstet Gynecol, vol. 200, pp. 188 e1-7, Feb 2009. The Reimbursement Policy Stateme nt detai led above has received due con side ration as defined in the Reimbursement Po licy Stateme nt Po licy a nd is a pprove d. Archived
REIMBURSEMENT POLICY STATEMENT OHIO MEDICAIDOriginal Issue Date Next Annual Review Effective Date 06/01/2017 05/15 /2018 06/01/2017 Policy Name Policy Number Screening and Surveillance for Colorectal Cancer PY-0072 Policy Type Medical Administrative Pharmacy REIMBURSEMENT Reimbursement Policies prepared by CSMG Co. and its affiliates (including CareSource) are intended to provide a general reference regarding billing, coding and documentation guidelines. Coding methodology, regulatory requirements, industry-standard claims editing logic , benefits design and other factors are considered in developing Reimbursement Policies. In addition to this Policy, Reimbursement of services is subject to member benefits and eligibility on the date of service, medical necessity, adherence to plan policies and procedures, claims editing logic, provider contractual agreement, and applicable referral, authorization, notification and utilization management guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, i llness, or injury and without which the patien t can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowes t cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any federal or state coverage mandate, Evidence of Coverage documents, Medical Policy Statem ents, Provider Manuals, Member Handbooks, and/or other policies and procedures. This Policy does not ensure an authorization or Reimbursement of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service (s) referenced herein. If there is a conflict between this Policy and the plan contract ( i.e. , Evidence of Coverage), then the plan contract ( i.e. , Evidence of Coverage) will be the controlling document used to make the determination. CSMG Co. and its affiliates may use reasonable discretion in interpreting and applying this Policy to services provided in a particular case and may modify this Policy at any time. Contents of Policy REIMBURSEMENT POLICY STATEMENT ………………………………………………………….. 1 TABLE OF CONTENTS …………………………………………………………………………………… .. 1 A.SUBJECT ……………………………………………………………………………………………….. 2 B.BACKGROUND ……………………………………………………………………………………….. 2 C.DEFINITIONS ………………………………………………………………………………………….. 2 D.POLICY ………………………………………………………………………………………………….. 2 E.CONDITIONS OF COVERA GE ………………………………………………………………….. 3 F.RELATED POLICIES/RUL ES ……………………………………………………………………. 4 G.REVIEW/REVISION HISTORY ………………………….. ……………………………………… 4 H.REFERENCES ………………………………………………………………………………………… 4Archived Screening and Surveillance for Colorectal Cancer Ohio Medicaid PY-0072 Last Revised 06/01/17 2 A. SUBJECT Screening and Surveillance for Colorectal Cancer B. BACKGROUND Reimbursement policies are designed to assist you when submitting claims to CareSource. They are routinely updated to promote accurate coding and policy clarification. These proprietary policies are not a guarantee of payment. Reimbursement for claims may be subject to limitations and/or qualifications. Reimbursement will be established based upon a review of the actual services provided to a member and will be determined when the claim is received for processing. Health care providers and their office staff are encouraged to use self-service channels to verify members eligibility. It is the responsibility of the submitting provider to submit the most accurate and appropriate CPT/HCPCS code(s) for the product or service that is being provided. The inclusion of a code does not imply any right to reimbursement or guarantee claims payment. CareSource will reimburse participating providers for medically necessary and preventive screening tests for colorectal cancer as required by state requirements through criteria based on recommendations from the U.S. Preventive Services Task Force (USPSTF) and the American College of Gastroenterology (ACG). Applicable clinical criteria for the following colorectal cancer screening health services are described i n the corresponding medical policy entitled Screening and Surveillance for Colorectal Cancer : Air Contrast Barium Enema (ACBE) every 5 years; Flexible sigmoidoscopy every 5 years in combination with fecal occult blood testing (FOBT) or fecal immunochemical testing (FIT) every 3 years. Multi-targeted stool DNA test (Cologuard) every 3 years when clinical criteria are met; (see the Screening and Surveillance for Colorectal Cancer policy ) Screening Colonoscopy every 10 years in average risk patients. Screening Colonoscopy every 24 months in high risk patients FOBT or FIT annually C. DEFINITIONS See corresponding CareSource medical policy titled, Screening and Surveillance for Colorectal Cancer: https://www.caresource.com/documents/medicaid-screening-and-surveillance-for-colorectal-cancer/ D. POLICY CareSource will reimburse providers for Screening and Surveillance for Colorectal Cancer utilized through Medicaid when approved by CareSource. I. Medicaid screening and surveillance for colorectal cancer are reimbursed based on the Medicaid fee schedule. II.If required, providers must submit their prior authorization number their claim form, as well as appropriate HCPCS and/or CPT codes along with appropriate modifiers in accordance with CMS. Archived Screening and Surveillance for Colorectal Cancer Ohio Medicaid PY-0072 Last Revised 06/01/17 3 E.CONDITIONS OF COVERA GE Reimbursement is dependent on, but not limited to, submitting approved HCPCS and CPT codes along with appropriate modifiers. Please refer to : http://jfs.ohio.gov/ The following list(s) of codes is provided as a reference. This list may not be all inclusive and is subject to updates. Please refer to the above referenced sources for the most current coding information. CPT Codes Code Description 45378 Colonoscopy, flexible; diagnostic, including collection of specimen(s) by brushing or washing, when performed (separate procedure) 45379 Colonoscopy, flexible; with removal of foreign body(s) 45380 Colonoscopy, flexible; with biopsy, single or multiple 45381 Colonoscopy, flexible; with directed submucosal injection(s), any substance 45382 Colonoscopy, flexible; with control of bleeding, any method 45388 Colonoscopy, flexible; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre-and post-dilation and guide wire passage, when performed) 45384 Colonoscopy, flexible; with removal of tumor(s), polyp(s), or other lesion(s) by hot biopsy forceps 45385 Colonoscopy, flexible; with removal of t umor(s), polyp(s), or other lesion(s) by snare technique 45386 Colonoscopy, flexible; with transendoscopic balloon dilation 45389 Colonoscopy, flexible; with endoscopic stent placement (includes pre-and post-dilation and guide wire passage, when performed) 45391 Colonoscopy, flexible; with endoscopic ultrasound examination limited to the rectum, sigmoid, descending, transverse, or ascending colon and cecum, and adjacent structures 45392 Colonoscopy, flexible; with transendoscopic ultrasound guided intramural or transmural fine needle aspiration/biopsy(s), includes endoscopic ultrasound examination limited to the rectum, sigmoid, descending, transverse, or ascending colon and cecum, and adjacent structures 45390 Colonoscopy, flexible; with endoscopic mucosal resection 45393 Colonoscopy, flexible; with decompression (for pathologic distention) (e.g., volvulus, megacolon), including placement of decompression tube, when performed 45398 Colonoscopy, flexible; with band ligation(s) (e.g., hemorrhoids) 81528 Oncology (colorectal) screening, quantitative real-time target and signal amplification of 10 DNA markers (KRAS mutations, promoter methylation of NDRG4 and BMP3) and fecal hemoglobin, utilizing stool, algorithm repo rted as a positive or negative result (Cologuard) Archived Screening and Surveillance for Colorectal Cancer Ohio Medicaid PY-0072 Last Revised 06/01/17 4 AUTHORIZATION PERIOD If applicable, reimbursement is dependent upon products and services frequency, duration and timeframe set forth by Medicaid. F. RELATED POLICIES/RUL ES Screening and Surveillance for Colorectal Cancer, MM-0040 (Medicaid) G. REVIEW/REVISION HISTORY DATE ACTION Date Issued 06/01/2017 Date Revised Date Effective 06/01/2017 H. REFERENCES 1. Ohio Department of Medicaid. (2016, May 16). Retrieved May 16, 2016, from http://medicaid.ohio.gov/FOROHIOANS/CoveredServices.aspx#669179-preventive-exams-and-screenings The Reimbursement Policy Stateme nt detai led above has received due con side ration as defined in the Reimbursement Po licy Stateme nt Po licy a nd is a pprove d. Archived
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