5101:3-10-32 Ostomy and urological supplies.

(A) Ostomy supplies

(1) Coverage determination

(a) The quantity of ostomy supplies needed by a consumer is determined primarily by the type of ostomy, its location and construction, and the condition of the skin surface surrounding the stoma. The department recognizes that there will be variation according to individual consumer need and that this need may vary over time.

(b) The provider must maintain documentation in the consumer's medical record that clearly supports the medical necessity for ostomy supplies.

(c) Ostomy supplies must be prescribed by a prescriber actively involved in managing the consumer's medical care through a comprehensive plan of care that addresses the need for ostomy supplies on a continual basis. This prescription must contain the original signature of the ordering prescriber that attests to this medical necessity and clearly designates the quantity and type of ostomy supplies being prescribed.

(d) Any change to a consumer's care plan regarding the quantity or type of ostomy supplies requires a new prescription be obtained by the provider that details the changes to the care plan. The provider must keep any new orders regarding the consumer's ostomy care plan in the consumer's medical record to be available for review by the department upon request.

(2) Coverage limitations

(a) Provision of ostomy supplies is limited to a one-month supply per calendar month. Consumers are eligible for re-supply on a calendar month basis starting with the initial dispensing date. The provider is responsible for determining the appropriate amount of ostomy supplies on any given month based on consumer need. The stockpiling of ostomy supplies by a consumer is not allowed.

(b) Providers are responsible for determining whether additional ostomy supplies have been acquired by the consumer from a different provider during any given month. Ostomy supplies dispensed over and above the stated maximum allowables as listed in appendix A to rule 5101:3-10-03 of the Administrative Code will not be reimbursed without prior authorization.

(c) Ostomy supplies for consumers residing in long term care facilities are reimbursed through the facility's cost report.

(d) When a liquid barrier is necessary, either liquid or spray or individual wipes or swabs is appropriate. Only a single type is reimbursable by the department at a given time.

(e) Consumers with continent stomas may use either a stoma cap, stoma plug, or gauze pads to prevent/manage drainage. Only a single type is reimbursable by the department at any given time.

(f) Consumers with urinary ostomies may use either a bag or bottle for drainage at night. Only a single type is reimbursable by the department at any given time.

(B) Urological supplies

(1) Coverage determination

(a) The provider must document in the consumer's medical record the medical necessity for urological supplies.

(b) Urological supplies must be prescribed by a prescriber actively involved in managing the consumer's medical care through a comprehensive plan of care that addresses the need for urological supplies on a continual basis. This prescription must contain the original signature of the ordering prescriber that attests to this medical necessity and clearly designates the quantity and type of urological supplies being prescribed.

(c) Any change to a consumer's care plan regarding the quantity and type of urological supplies requires that a new prescription be obtained by the provider that details the changes to the care plan. The provider must maintain any new orders regarding the consumer's urological care plan in the consumer's medical record to be available for review by the department upon request.

(d) Indwelling catheters

(i) No more than one catheter per month is covered for routine catheter maintenance. Non-routine catheter changes are covered when documentation substantiates medical necessity, such as for the following indications:

(a) Catheter is accidentally removed (e.g., pulled out by consumer); or

(b) Malfunction of catheter (e.g., balloon does not stay inflated, hole in catheter); or

(c) Catheter is obstructed by encrustation, mucous plug or blood clot; or

(d) History of recurrent obstruction or urinary tract infection for which it has been established by the prescriber that an acute event is prevented by a scheduled change frequency of more than once per month.

(ii) When a specialty indwelling catheter or an all-silicone catheter is used, documentation must be maintained in the consumer's medical record that attests to the medical necessity for that catheter rather than a straight foley type catheter with coating.

(iii) A three-way indwelling catheter either alone or with other components will be covered based on medical necessity documentation in the consumer's medical record.

(e) Catheter insertion tray

(i) One insertion tray will be covered per episode of indwelling catheter insertion. More than one tray per episode will not be reimbursed by the department.

(ii) One intermittent catheter with insertion supplies will be covered per catheterization episode based on supporting documentation of medical necessity in the consumer's medical record.

(f) Urinary drainage collection system

(i) Coverage is authorized for the routine changes of the urinary collection system based on supporting documentation of medical necessity in the consumer's medical record.

(ii) Leg bags are covered for consumers who are ambulatory or are chair or wheelchair bound. The use of leg bags for bedridden consumers is not authorized.

(iii) If there is a catheter change and an additional drainage bag change within a month, the combined utilization for these supplies should be considered by the provider when determining if prior authorization is necessary due to the consumer's medical need to exceed the monthly maximum allowable that is designated for these supplies in appendix A to rule 5101:3-10-03 of the Administrative Code.

(iv) Payment will not be made for concurrent use of a vinyl and a latex bag.

(g) Intermittent irrigation of indwelling catheters

(i) Supplies for the intermittent irrigation of an indwelling catheter are covered by the department when they are used on an as-needed (non-routine) basis in the presence of acute obstruction of the catheter. Documentation supporting medical necessity must be maintained in the medical record and available for review by the department. Routine intermittent irrigations of a catheter are not reimbursable by the department. Routine irrigations are defined as those performed at predetermined intervals.

(ii) Covered supplies for non-routine irrigation of a catheter include either an irrigation tray or an irrigation syringe, and sterile water/saline. Syringes, trays, sterile saline or water are not reimbursable by the department when used for routine irrigation. Irrigation solutions containing antibiotics and chemotherapeutic agents and solutions such as acetic acid or hydrogen peroxide used for the treatment or prevention of urinary obstruction are not reimbursable by the department.

(h) Continuous irrigation of indwelling catheters

(i) Supplies for continuous irrigation of a catheter are covered if there is a history of obstruction of the catheter and the patency of the catheter cannot be maintained by intermittent irrigation in conjunction with medically necessary catheter changes. Supplies used as a result of continuous irrigation being utilized as a primary preventive measure are not reimbursable by the department. Documentation that verifies the medical necessity of catheter irrigation and in particular continuous irrigation as opposed to intermittent irrigation must be maintained in the consumer's medical record. This documentation must indicate the rate of solution administration and the consumer's duration of need.

(ii) Covered supplies for medically necessary continuous bladder irrigation include a three-way foley catheter, irrigation tubing set, and sterile water/saline. The department does not reimburse for more than one irrigation tubing set per day for continuous catheter irrigation.

(iii) Irrigation solutions containing antibiotics and chemotherapeutic agents are not reimbursable by the department. Reimbursement claims for irrigating solutions such as acetic acid or hydrogen peroxide should be billed using the appropriate healthcare common procedure coding system (HCPCS) code for sterile water/saline .

(iv) Continuous irrigation is considered by the department to be a temporary measure. Continuous irrigation for more than two weeks duration requires supporting medical necessity documentation in the consumer's medical record.

(i) Intermittent catheterization

(i) Intermittent catheterization is covered by the department when the basic coverage criteria in paragraph (B)(1)(i)(ii) of this rule are met and the consumer or consumer's caregiver can perform the procedure. Documentation supporting the capability of the consumer or consumer's caregiver to perform this procedure must be included in the consumer's medical record.

(ii) For each episode of covered catheterization, the department will reimburse for one catheter or one sterile catheter kit if the following additional coverage criteria are met:

(a) The consumer is immunosuppressed; or

(b) The consumer has radiologically documented vesico-ureteral reflux while on a program of intermittent catheterization; or

(c) The consumer is a spinal-cord injured female with neurogenic bladder who is pregnant (covered for duration of pregnancy only); or

(d) The consumer has had distinct, recurrent urinary tract infections, while on a program of sterile intermittent catheterization, two or more times within the twelve months prior to the initiation of using sterile intermittent catheter kits.

(iii) A consumer is considered to have a urinary tract infection if he or she has a documented urine culture with greater than ten thousand colony forming units of a urinary pathogen and concurrent presence of one or more of the following signs, symptoms or laboratory findings:

(a) Fever (oral temperature greater than thirty-eight degrees Celsius or 100.4 degrees Fahrenheit); or

(b) Systemic leukocystosis; or

(c) Change in urinary urgency, frequency, or incontinence; or

(d) Appearance of new or increase in autonomic dysreflexia (sweating, bradycardia, blood pressure elevation); or

(e) Physical signs of prostatitis, epididymitis, orchitis; or

(f) Increased muscle spasms; or

(g) Pyuria (greater than five white blood cells (WBCs) per high powered field).

(iv) If the medical necessity of sterile catheterization is not documented in the consumer's medical record, sterile supplies associated with this procedure are not reimbursable by the department.

(v) Use of a coude (curved) tip catheter in females is considered to be rarely necessary. When a coude tip catheter is used (for either males or females), there must be documentation of medical necessity in the consumer's medical record for the use of this type of catheter rather than a straight tip catheter.

(j) External catheters or urinary collection devices

(i) Male external catheters (condom-type) or female external urinary collection devices are covered for consumers who have permanent urinary incontinence when used as an alternative to an indwelling catheter.

(ii) Male external catheters or female external urinary collection devices will not be reimbursable if the consumer is currently also using an indwelling catheter.

(iii) Specialty type male external catheters such as those that inflate or that include a faceplate or extended wear catheter systems are covered only when documentation in the consumer's medical record establishes the medical necessity for such a catheter.

(iv) For female external urinary collection devices, more than one metal cup per week or one pouch per day is not reimbursable.

(k) Miscellaneous supplies

(i) Appliance cleaner (A5131) is covered when used to clean the inside of certain urinary collecting appliances (e.g., A5102 or A5112). Reimbursement is not approved for this cleaner unless the consumer is also using one of the specified corresponding appliances.

(ii) Adhesive catheter anchoring devices and catheter leg straps for indwelling urethral catheters are covered. A catheter/tube anchoring device is covered and separately reimbursable only when it is used to anchor a covered suprapubic tube or nephrostomy tube.

(2) Coverage limitations

(a) Provision of urological supplies is limited to a one-month supply per calendar month. Consumers are eligible for re-supply on a calendar month basis starting with the initial dispensing date. The provider is responsible for determining the appropriate amount of urological supplies on any given month based on consumer need. The stockpiling of urological supplies by a consumer is not allowed.

(b) Providers are responsible for determining whether additional urological supplies have been acquired by the consumer from a different provider during any given month. Urological supplies dispensed over and above the stated maximum allowables as listed in appendix A to rule 5101:3-10-03 of the Administrative Code will be not be reimbursed without prior authorization.

(c) Urological supplies for consumers in long term care facilities are reimbursed through the facility's cost report.

(C) Reimbursement

Ostomy and urological supplies are reimbursed at the lesser of the department's fee schedule contained in appendix DD to rule 5101:3-1-60 of the Administrative Code or the provider's usual and customary charge.

Effective: 08/02/2011
R.C. 119.032 review dates: 09/20/2010 and 08/01/2016
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 08/17/09