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Coverage Guidelines For Durable Medical Equipment Activity Chairs Activity/Positioning Chairs Activity/positioning chairs are designed to provide stability and support, maintain body alignment, decrease likelihood of postural deformities, and enhance upper body extremity function for an EPSDT recipient with physical disabilities. Activity Chair Activity Chairs and accessories are covered for an EPSDT recipient who has physical disabilities and requires positioning support to sit and perform activities. An Activity Chair is considered medically necessary when a recipient meets any one of the following criteria: Cannot safely sit in a regular chair, commercially available highchair, or other conventional seating option; Needs additional support and stability for fine motor activities; Has decreased trunk support and stability for fine motor activities; Must use arms to maintain sitting balance; Requires external support to maintain upright position and good body alignment; Has no functional protective or righting reaction; or Must be in an upright supported position for safe and effecting feeding and without this chair would have to be held by the caregiver for feeding. All accessories must be medically justified. A tilt/recline option is covered when the recipient: Cannot maintain head control in the upright position Requires pressure relief Requires a tilted position to compensate for tonal changes, or Must be tilted for proper digestion and to avoid reflux A mobile base is covered when it is medically necessary to move the recipient to different parts of the environment with the rest of the family for safety or for medically necessary activities. A Hi Lo feature is covered when height adjustments are needed for medically necessary activities or to allow the recipient to get into or out of the chair independently. Hi Lo Positioning Activity Chair Hi Lo Positioning Chairs and accessories are covered for a recipient who has more severe physical disabilities and needs optimum positioning support. A Hi Lo Positioning Chair is considered medically necessary when a recipient meets any one of the following criteria: Has non-functional head or trunk control requiring customized postural support to maintain a sitting position; Cannot sit unsupported due to poor static and dynamic sitting balance; Requires maximum support for upright positioning; Cannot interact with the environment without this level of support; or Requires varying sitting heights to participate in medically necessary activities. Hi Lo Indoor Base/Frame A Hi Lo Indoor Base is covered for the recipient who has a wheelchair seating system that can be transferred from a mobility base to an indoor base and is used as an activity/positioning chair. A Hi Lo Indoor Base is considered medically necessary when a recipient meets any one of the following criteria: A variety of heights are needed for the recipient to perform medically necessary activities ; or At the low height, the recipient is able to get into and out of the chair independently. A completed Request for Prior Authorization for DME-Children Only form (childrens_dme_form.pdf) from a physical or occupational therapist involved in the care of the recipient is required for prior approval of all Activity/Positioning Chairs and Frames. The physical or occupational therapist completing the evaluation shall not be employed by or have financial relationship with the medical equipment provider. For Prior approval, the DME provider shall submit a completed Request for Prior Authorization for DME-Children Only form, and any supporting documentation from the physical or occupational therapist that: Demonstrates that the activity/positioning chair requested, and each of its components, are medically necessary and are the least expensive device that is appropriate for the recipient's medical condition; and Describes other less expensive devices that were considered and provides rationale as to why they were not appropriate for that recipient. Click here for an approved PDF version of the Activity Chairs coverage guidelines. Apnea Monitor Indications Apnea Monitors are covered for those EPSDT recipients who are at risk of life threatening cessation of breathing. Such conditions include SIDS siblings, apnea in a newborn, severe bronchopulmonary displasia, gastroesophogeal reflux, etc. Consideration will be given to older children who are at risk of apnea due to other respiratory conditions i.e., tracheostomy. Coverage and Payment Policy Apnea monitors will be covered with prior authorization if any of the above conditions are met. Rental of the monitor will be covered until the child reaches ten months of age. Approval will continue in three months intervals until the physician feels that the equipment is no longer needed. Six months approval will be considered for older children when the condition is long term. All supplies used with Apnea monitors are covered in the rental price. Automatic External Defibrillator Automatic External Defibrillator (AED), garment type The majority of sudden cardiac deaths related to coronary artery disease are thought to be from ventricular fibrillation. Ventricular tachycardia has also been implicated in these situations. Early defibrillation increases patient survival. Those patients defibrillated within one minute of the episode may achieve extremely high survival rates (up to 97%). A ten minute delay in treatment yields a successful survival rate as low as 5%. 75% of ventricular fibrillations occur in the home. The wearable device functions as both a defibrillator and a cardioverter by varying the amount of electrical shock, based on the identified cardiac rhythm. Coverage and Payment Policy Prior Authorization is required. Requesting provider must submit the following documentation: The beneficiary requires and is in a waiting period for an implantable device; or The use of an implantable cardioverter/defibrillator is contraindicated; or A previously implanted device requires removal; or The beneficiary has been approved and is on a transplant waiting list; and Documentation must also include one of the following: An episode of ventricular fibrillation or an episode of ventricular tachycardia of at least 30 second duration is documented. The episode may not be due to a transient or reversible cause and may not have occurred during the first 48 hours post myocardial infarction; or Documentation of a familial or inherited condition puts the beneficiary at a high risk of life threatening tachyarrhythmia; or Documentation of a prior myocardial infarction or cardiomyopathy and a left ventricular ejection fraction of 0.35 or less. Initial approval will be for a rental period of 90 days. Extensions will require submission of an updated clinical evaluation, report of compliance with use and an updated treatment plan. Click here for an approved PDF version of the Automatic External Defibrillator Coverage Guidelines Breast Pumps A breast pump is a device used to extract milk from the breast of a lactating mother for infant feeding. Three types of breast pumps covered under RI Medicaid include: Manual - no prior authorization is required Electric - no prior authorization is required Hospital-Grade - prior authorization is required Coverage and Payment Policy Electric Breast Pump - when recommended by the ordering provider and when one of the following is met: Baby in NICU with anticipated extended stay Difficult latch/suppressed latch Inadequate milk production Poor infant weight gain Jaundice Failure to establish effective breastfeeding pair Mastitis Engorgement Retracted nipple(s) Cracked nipple(s) Hospital-Grade Breast Pump - may generally be considered clinically appropriate when there is prolonged infant hospitalization and one or more of the following conditions that may adversely impact feeding directly from the breast: Prematurity (including multiple gestation); Neurologic disorder; Genetic abnormality; Anatomic and mechanical malformation (e.g. cleft lip or palate); or Congenital malformation requiring surgery (e.g. respiratory, cardiac, gastrointestinal, or central nervous system). This service requires prior authorization to include prescription from the ordering provider; and documentation supporting the medical necessity of the item. Hospital-Grade Pumps are available as rentals only. Initial authorization will be for three months. Continued coverage must be documented by the treating physician every three months for a maximum rental period of ten months. Click here for an approved PDF version of the Breast Pump coverage guidelines. Car Seats Car Seats Specialized car seats are safety and positioning devices used specifically for children with special needs who can no longer fit in a conventional car seat but continue to need special support or when conventional car seats are not medical appropriate. Coverage Guidelines A specialized car seat may be covered for recipients who: Are not able to fit safely into a conventional car seat OR exhibit behavioral manifestations of a documented medical Are not able to be properly supported and safe in the vehicle during normal transport and Exhibit one more of the following medical condition(s): Significant head and trunk instability and/or weakness, Significant hypotonicity, hypertonicity, athetosis, spasticity, or muscle spasming which results in uncontrollable movement and position change. Absence or latency or protective reactions, Inability to maintain an unsupported seating position independently, Severe seizure activity that results in uncontrollable movement and position change (such as tonic-clonic seizures); Othopedic disease process resulting in significant boy fragility or significant contractures that would result in a child's instability to perform postural corrections due to vehicle motion; Behaviors that put the recipient or driver at risk of injury; Children in spica casts A completed Request for Prior Authorization for DME-Children Only form (http://www.eohhs.ri.gov/Portals/0/Uploads/Documents/childrens_dme_form.pdf) from a physical or occupational therapist involved in the care of the recipient is required for prior approval of all Car Seats. The physical or occupational therapist completing the evaluation shall not be employed or have a financial relationship with the medical equipment provider. Click here for an approved PDF version of the car seats coverage guidelines. Commodes A commode is covered when the patient is incapable of utilizing regular toilet facilities. Coverage and Payment Policy A commode is covered when the beneficiary is physically incapable of utilizing regular toilet facilities. This would occur in the following situations: The beneficiary is confined to a single room, or The beneficiary is confined to one level of the home environment and there is no toilet on that level, or The beneficiary is confined to the home and there are no toilet facilities in the home. An extra wide/heavy duty commode chair is covered for a beneficiary who weighs 300 pounds or more. A commode chair with detachable arms is covered if the detachable arms feature is necessary to facilitate transferring the beneficiary or if the beneficiary has a body configuration that requires extra width. Commode chair with seat lift mechanism is covered if the beneficiary has medical necessity for a commode and meets the coverage criteria for a seat lift mechanism. Duplicate devices for multiple bathrooms are not covered. Click here for an approved PDF version of the Commode coverage guidelines. Compression Garment A compression garment is a custom made or custom fitted support garment fabricated to apply varying degrees of pressure to specific anatomic areas. These garments affect stress on vein walls, muscle pump activity, tissue pressure and circulation. These garments are also used in the treatment of burn patients. The majority of applications do not require custom made garments. Coverage and Payment Policy Custom made garments require prior authorization. Coverage guidelines for the following covered items: Compression gauntlets and gloves Compression sleeves Custom made compression garments Lymphedema Sleeves Requesting provider must submit the following information: A written prescription from the treating provider. Documentation of a recent face to face evaluation by the prescribing provider which includes physical findings and recommendation for the use of requested garments. A qualified health professional must measure the patient for the requested garments. One of the following medical conditions must be documented: a. Open ulcer b. Lymphedema c. Prevention of initial or recurrent statis ulcer d. Venous insufficiency e. Chronic edema f. Prevention of deep venous thrombosis during pre and postpartum periods g. Post thrombotic/phlebitic syndrome h. Thrombosis prevention during periods of immobilization i. Thrombophlebitis Burn Pressure Garments are covered when medically necessary to enhance healing, reduce swelling, treat contractures and hypertropic scars suffered by severely burned patients. Compression Stockings are covered in periods of circulatory impairment, limited to 6 pairs per year. Click here for an approved PDF version of the Compression Garment coverage guidelines. Continuous Passive Motion Continuous Passive Motion (CPM) Devices are utilized to keep a joint in motion without patient assistance. CPM devices are meant to be used as an adjunct to conventional physical or occupational therapy programs. A CPM device is covered when all of the following criteria are met: Coverage is limited to post total knee replacement (TKR) or arthroplasty. The use of the device must commence within two days of surgery. The device must be prescribed by a physician and a treatment plan must be in place which includes active physical therapy. Coverage and Payment Policy This device requires prior authorization. Requesting provider must submit the following information: Date of surgery and type of surgery performed Date CPM therapy began Date of discharge from the hospital Coverage is limited to that part of a 21-day period, following surgery during which the device is used in the beneficiary's home Approval will be for a maximum of 21 days. Click here for an approved PDF version of the Continuous Passive Motion Devices coverage guidelines. Cranial Remolding Orthosis Positional Plagiocephaly encompasses both positional plagiocephaly (unilateral flattening of the parieto-occipital region, compensatory anterior shift of the ipsilateral ear, bulging of the ipsilateral forehead) and positional brachycephaly (symmetric flattening of the occiput, foreshortened anterior-posterior dimension of the skull, compensatory biparietal widening) and the combination of both deformities. The management of positional skull deformation is nonsurgical. This guideline does not address craniosynostosis. Coverage and Payment Policy This service requires prior authorization. Patient must be age 18 months or younger. If patient is age 6 months or younger, request must be preceded by 2 or more months of documented correctional positioning, physical therapy or medical management without improvement. If Torticollis is identified, Torticollis therapy must be documented as part of the treatment plan. A second helmet may be approved after review of documentation for clinical need (examples: worn or degraded helmet materials, need for modified helmet due to lack of response) and beneficiary is age 18 months or less. Click here for an approved PDF version of the Cranial Remolding Orthosis coverage guidelines. Diapers/Underpads/Liners Indications Diapers/Underpads/Liners are limited to those recipients three years of age and older and who are incontinent due to a medical condition and all other forms of treatment modalities have been exhausted. RI Medicaid DME providers wishing to dispense these services to an approved recipient must have proof of medical necessity on file. Proof of medical necessity is valid for 12 months from the date of issue. Dynamic Splinting Click here for an approved PDF version of the Dynamic Splinting coverage guidelines. Emergency Response Systems (HCBS Waiver only) Personal Emergency Response System (PERS) Personal Emergency Response System (PERS) is an electronic device that enables certain individuals at high risk of institutionalization to secure help in an emergency. The individual may also wear a portable "help" button to allow for mobility. The system is connected to the individual's phone and programmed to signal a response center once a "help" button is activated. Trained professionals staff the response center, as specified by the Center for Adult Health contract standards. Coverage and Payment Policy PERS is covered for those individuals who live alone, or who are alone for significant parts of the day, and have no regular caretaker for extended periods of time, and who would otherwise require extensive routine supervision. The professional ordering is responsible for ensuring the beneficiary understands and is capable of using the Emergency Response System. This services is for individuals eligible for Home and Community Based Services (HCBS) under the 1115 demonstration only. Click here for an approved PDF version of the Emergency Response System coverage guidelines. Enteral Nutrition and Total Parenteral Nutrition Clinical Guidelines for Enteral Nutrition These Guidelines identify the clinical information that the Rhode Island Medical Assistance Program requires to determine medical necessity for Enteral Nutrition products. The Guidelines are based on generally accepted standards of medical practice, review of medical literature, federal and state policies, and laws applicable to Medicaid programs. Enteral Nutrition is defined as supplemental feeding provided via the gastrointestinal tract orally, or through a tube, catheter or stoma distal to the mouth. Clinical Coverage Determination of medical necessity for enteral products shall be based upon a combination of clinical data and the presence of indicators that would affect the relative risks and benefits of the product, including but not limited to: Enteral Nutrition, whether orally or by tube feeding, is used a therapeutic regimen to prevent serious disability or death in a person with a medically diagnosed condition that precludes the full use of regular food. The person presents clinical signs and symptoms of impaired digestion mal-absorption, or nutritional risk, as indicated by the following anthropometric measures: Weight Loss that presents actual or potential for developing malnutrition as follow: a. In adults: i. Involuntary or acute weight loss equal to or greater that 10% of usual body weight over a three to six month period or a Body Mass Index (BMI) below 18.5. b. In neonates, infants, and children showing: i. Very low birth weight (less than 1500 grams) even in the absence of gastrointestinal, pulmonary, or cardiac disorders; ii. Lack of weight gain or weight loss to a value less than two standard deviations below the age appropriate mean in one month for children under age six months or in two months for children aged six to twelve months; iii. No weight gain or abnormally slow weight gain for three months for children older than one year; or iv. Weight for height less than the tenth percentile, abnormal laboratory tests pertinent to the diagnosis and risk factors for actual or potential malnutrition have been identified and documented. 3. Enteral Nutrition is indicated as the primary source of nutritional, i.e., is essential for the management of factors that impair digestion or cause mal-absorption, for surgical preparation, or post-operative care. 4. A written plan of care has been developed for regular monitoring of signs and symptoms to detect improvement in the person’s condition. Nutritional status should be monitored regularly. 5. Diagnosis of inborn errors of metabolism that require medically necessary formula used for specific metabolic conditions such as (but not limited to): Phenylketonuria (PKU), homocystinuria, maple syrup urine disease, proprionic aciduria and methylmalonic aciduria. Non-Coverage Enteral Nutrition products shall not be considered medically necessary under certain circumstances including but not limited to, the following: a. A medical history and physical examination have been performed and other alternatives comparable in effect and available to the member that are more conservative or less costly to RI Medicaid have been identified to minimize nutritional risk; b. The person is underweight but has ability to meet nutritional needs through the use of regular food consumption; c. Enteral products are used for a weight loss or dieting program; d. The presence of food allergies, lactose intolerance, or dental problems when nutritional requirements may be met through an alternative food source comparable in effect and available to the member; or e. Enteral products used as supplements to a normal or regular diet in a person showing no clinical indicators of nutritional risk. f. No medical history or physical examination has been taken and/or there in no documentation to RI Medicaid that supports the need for enteral nutrition products. Requests for Enteral Nutrition for lack of appetite or cognitive problems will be denied. Compounding of Enteral Nutrition products is a non-covered service. Submitting clinical documentation and prior authorization request: Prior authorization will be required and determinations made on a case by case basis. Approval of prior authorization is still subject to all general conditions of Rhode Island Medicaid including member eligibility, other insurance and program restrictions. Requests for prior authorization must be accompanied by clinical documentation, including a recent history and physical examination which supports medical necessity for the requested product. Documentation must also include a complete Rhode Island Medical Necessity Review Form including but not limited to, specific data for requested calories and units of product per day, number of monthly refills, and duration of need. Divide the number of calories per day by 100, (e.g., 100 calories equals 1 unit) and multiply that number by the number of days for treatment. This equals total units. Prior authorization shall be valid for 12 months from date of issuance. All change in treatment must be documented in writing and a new prior authorization is required. For Medicaid enrolled children also enrolled in WIC, Medicaid will be the primary payer for enteral nutrition products when such products are medically necessary and are covered by the Medicaid State Plan. Click here for an approved PDF version of the Enteral Nutrition coverage guidelines. Click here for a copy of the Certificate of Medical Necessity for Enteral Nutrition and Total Parenteral Nutrition. Clinical Guidelines for Total Parenteral Nutrition Total Parenteral Nutrition is a method of providing fluid, nutritional and needed metabolic products for those patients unable to maintain needed oral intake due to surgical, malignant or malabsorption diseases which cannot be treated by alternative therapies such as modified diets, nasogastric feeding tubes, and gastric or jejunal feeding tubes. Coverage and Payment Policy Prior authorization is required. Parental nutrition will be covered when the following conditions are met: a. The gastrointestinal tract is nonfunctional or cannot be accessed and the patient cannot be adequately nourished by oral diets or enteral nutrition. AND b. The beneficiary has a diagnosis of a disorder or disease process which impairs absorption of sufficient nutrients to preserve weight. AND c. There is documentation of failed enteral nutrition. AND d. The Beneficiary has a caregiver who has been trained to provide the feedings or the beneficiary is able to independently administer the feedings. Click here for an approved PDF version of the Total Parenteral Nutrition coverage guidelines. Click here for a copy of the Certificate of Medical Necessity for Enteral Nutrition and Total Parenteral Nutrition. External Ambulatory Insulin Delivery Systems Insulin Delivery Devices for Managing Diabetes General: External insulin pumps that deliver insulin by subcutaneous infusion are proven and medically necessary for managing individuals with Type 1 or insulin requiring Type 2 Diabetes. This policy includes use of programmable disposable external insulin pumps. Prior Authorization is required. Coverage Criteria: Request must be for management of Type 1 or Type 2 Diabetes requiring insulin for management. Patient must have failed other management without use of insulin delivery pump device. Failure is defined as multiple extreme variations in blood sugar levels resulting in symptomatic interventions, emergency evaluations or hospitalizations and/or inability to maintain HbAlC levels at or under the appropriate target for the particular patient. Patient or family member must be trained and willing to utilize the device. If requesting clinician is not an Endocrinologist, requesting clinician must attest that patient has received appropriate consultations and that a treatment plan established in conjunction with an Endocrinologist is recorded in the patient record. Specialist in Diabetology or Endocrinology or primary care provider may initiate the request. Replacement: Coverage for replacement device will only be considered for approval after manufacturer's warranty has expired. Click here for an approved PDF version of the External Ambulatory Insulin Delivery Systems coverage guidelines. Gait Trainers Gait Trainers are devices designed to support a patient with lower extremity or trunk weakness in an upright or standing position while walking. Gait trainers may be used independently or under the supervision of a care taker. Coverage and Payment Policy Prior authorization is required for a gait trainer. Requesting provider must submit the following documentation: A letter of medical necessity and A functional assessment conducted by a physical or occupational therapist that includes: a. strength, range of motion, tone, sensation, balance, gait and ADL's. b. evidence that the recommended equipment can be accommodated and safely used in the beneficiary's home. c. evidence that the beneficiary has shown improvement in mobility or function or has maintained mobility or function with the user of such equipment in an inpatient or outpatient setting. d. documentation that the beneficiary is capable of independent and safe use of the gait trainer and/or the caretaker has been trained to monitor safe use of the gait trainer. e. a home therapy plan outlining the planned use of the requested gait trainer, documentation of the beneficiary's ability to follow such a plan, and the availability of a caretaker to supervise the use of the gait trainer. f. documentation that the beneficiary does not have sufficient access to equipment in an alternative setting. Non Coverage There is no expected improvement in mobility or maintenance of function. Click here for an approved PDF version of the Gait Trainers coverage guidelines. Gloves Coverage and Payment Policy Sterile (A4930) and non-sterile (A4927) gloves require prior authorization. Gloves for dressing changes and catheter management are limited to use by non-agency caregivers when documented by the prescriber that the beneficiary is at risk for contamination from the caregiver(s). Gloves are not billable by an adult care home, home health agency, or other service provider in order to meet OSHA guidelines. Gloves supplied by RI Medicaid are for non-agency caregiver's use. Agency staff should use gloves supplied by the Home Care Agency (non-sterile). The prescribing provider must submit the following information: diagnosis, start/stop dates of treatment, frequency of treatment; and documentation by the prescriber, that the beneficiary is at risk for contamination from caregiver(s); and indicate need for at least one procedure in either the A or B category listed below. A. Procedures for which non-sterile gloves will be used: Tracheal suctioning G/J or N/G tube feeding Bladder Catheterization Colostomy/Ileostomy care Dressing changes Wound management B. Procedures for which sterile gloves will be used: Central Venous Line Wound management/debridement Active infectious diseases requiring sterile procedures Gloves for use while performing hygiene care, including routine incontinence care, are not covered. Click here for an approved PDF version of the Gloves coverage guidelines. Click here for the Disposable Glove Certificate of Medical Necessity. Glucose Monitors Home Glucose Monitoring Devices Home Glucose Monitoring is appropriate for individuals with documented Diabetes who can better control their glucose levels by frequently checking glucose levels and utilizing testing results to determine the need for therapeutic modifications to medication, diet, or other aspects of their overall treatment plan. Home Glucose Monitoring devices will be covered for those beneficiaries with a documented diagnosis of: a. Type I Diabetes b. Type II Diabetes c. Gestational Diabetes Coverage and Payment Policy Requesting provider must submit the following information: Prescription signed and dated by the prescribing provider. Physician attestation that the beneficiary has Diabetes. Physician attestation that beneficiary is capable of proper use of the requested device or if not, that a responsible individual can be trained to properly use the requested device. Special devices for beneficiaries with visual or manual dexterity impairments will require the following information: Items 1, 2, and 3 above Provider attestation that beneficiary has such impairment significant enough to require use of the special device Requests for special devices require prior authorization. Additional Diabetic Supplies Lancets and blood glucose test strips that are necessary for the proper functioning of the device are covered. Supplies are only payable when the equipment meets coverage requirements. More than one spring powered lancet device per six months will rarely be medically necessary. Payment for normal, low and high calibrator solution/chips is included in the payment for the glucometer and is not reimbursable separately. Click here for an approved PDF version of the Home Glucose Monitoring Devices coverage guidelines. Continuous Glucose Monitoring (CGM) A Continuous Glucose Monitor (CGM) is an FDA-approved medical device that records glucose levels throughout the day and night utilizing an appropriate sensor. The sensor must be able to determine tissue glucose levels at predetermined intervals and transmit the information to a device capable of retaining the data and providing the patient with the needed information. CGMs are considered medically necessary for insulin-dependent individuals with poorly controlled blood sugar. For the purposes of these guidelines, "poorly controlled" blood sugar level is defined as unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected post-prandial hyperglycemia, or recurrent diabetic ketoacidosis. Continuous Glucose Monitors and all related supplies are covered under the Durable Medical Equipment (DME) benefit. Prior Authorization is required and approval is valid for a maximum of 12 months. Coverage Criteria INITIAL coverage will be considered medically necessary for individuals who meet the following criteria: a. The member has a diagnosis of insulin.:.dependent diabetes; AND b. The member requires multiple daily insulin administrations, or an insulin pump is being used. (Exceptions: Providers may request an exception from the insulin use requirement for individuals not receiving insulin due to physical disability, visual impairment, cognitive impairment, or age <18; and such instances may bypass this requirement. Other comorbidities will be reviewed on a case-by-case basis.); AND c. The member meets at least one of the following: i. HbAlc 7% or at a value that does not meet documented target treatment; OR ii. Frequent hypoglycemia or nocturnal hypoglycemia; OR iii. History of hypoglycemic unawareness; OR iv. Dawn phenomenon with fasting blood sugars frequently exceeding 200mg/dl; OR v. History of emergency room visit or hospitalization related to ketoacidosis or hypoglycemia; OR vi. Use of a compatible insulin pump to achieve glycemic control; OR vii. Pregnancy. OR d. The member has another non-diabetes-based condition causing disorder of glucose metabolism or improper endogenous insulin secretion resulting in frequent hypoglycemia or nocturnal hypoglycemia or hypoglycemic unawareness. Such disorders may include, but are not limited to, seizure disorder, insulinoma, genetic conditions causing hyperinsulinemia, effects from post-surgical conditions including post esophagectomy, post fundoplication, post gastrectomy, post gastric bypass, and post sleeve gastrectomy. Such cases should speak to hypoglycemic risk and events and will be reviewed on a case-by-case basis. . 2. CONTINUED USE is considered medically necessary in each of the following circumstances: a. There is objective documented evidence of improvement in control of diabetes (specific to baseline status of disease for individual members); OR b. There is documented evidence of compliance with a current CGM treatment plan based on log data of the device; OR c. If a member is new to RI Medicaid from another insurer and is stable on CGM. Replacement The replacement of a CGM system is considered reasonable and medically necessary when ALL the following indications are met: Supporting documentation is in the form of clinical notes or letters generated by a clinician overseeing the member's diabetic condition; AND The present monitor has been render d ineffective or inoperable due to EITHER:a. A change in condition that the current monitor is unable to accommodate; OR b. Damage by events outside the control of the user; AND The device has been used according to a current treatment plan; AND Continued use of the device is clinically supported; AND Device replacement cannot be obtained from the manufacturer or supplier for reasons including the expiration of device warranty; AND Loss/damage is not attributable to abuse, damage, or neglect on the part of the user; AND The cost of replacement rather than repair is justified by the nature of the damage and the useful lifetime of the device; AND Replacement is not an additional/backup monitor; AND Replacement monitor is synonymous to the monitor being replaced unless replacement has been necessitated by a change in member condition that the old device is unable to accommodate. Note: in cases where neither the make and model of the device being replaced nor directly competitive devices from other brands are available, approval of a new device will be based on meeting the Coverage Criteria set forth above. Non-coverage Continuous glucose monitors are not considered medically necessary under certain circumstances where effectiveness has not been established or when there is non-compliance or an inability to comply with a current treatment plan. Examples of such circumstances include, but are not limited to, the following: Non-FDA-approved devices. Remote continuous glucose monitoring devices, accessories, and additional hardware or software that are ancillary to CGMs and are not considered medically necessary (e.g., complementary watches.) Replacement of an existing CGM with another CGM for additional features which are not medically necessary. CGMs are contraindicated for individuals who are unable or unwilling to perform required necessary calibration of a CGM, which may include, but not be limited to, self-monitored blood glucose checks at least twice per day; or when a member's symptoms and clinical presentation do not match/align with device readings, or for members who do not maintain contact with their health care professionals. Submitting Clinical Documentation Requests for PA for continuous glucose monitors must be accompanied by clinical documentation that supports the medical necessity of the requested device. Clinical documentation by the provider of the supporting rationale for the requested device must show that the member's blood sugar remains poorly controlled despite appropriate adjustments to a physician-ordered and physician-monitored treatment plan based on previous self-monitoring. Specifically, documentation of medical necessity must include ALL the following: Documentation that indicates that the member remains compliant with the insulin therapy recommended by an endocrinologist for at least 3 months. Exceptions: Providers may request and exception to the compliance requirement due to co-morbidities that inhibit the ability to self-monitor blood sugar or self-administer insulin. Requests for exceptions will be considered on a case-by-case basis. Documentation that indicates the member's HbAlC level(s) (at least 2 readings representing at least 6 months). Documentation demonstrating that criteria for Initial or Continued Coverage are met as appropriate to the clinical situation as outlined above. Click here for an approved PDF version of the Continuous Glucose Monitoring (CGM) coverage guidelines. Hearing Aids A hearing aid is any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing. Coverage and Payment Policy Prior Authorization is required. Licensed Dealers must submit the following documentation: Prior authorization form. A Certificate of Medical Necessity form signed by a licensed physician attesting to the beneficiary's need for a hearing aid based on an otological exam. A copy of the results of the audiometric testing (completed within one year) that supports the need for the hearing aid. In most cases this will be an audiogram with Speech Reception Threshold and Word Recognition Scores. Alternate industry-accepted test results are acceptable when it is not possible to do the audiogram, SRT and/or Word Recognition testing. Dealers requesting prior approval for a cost plus mark-up repair or specialty hearing device such as FM system must also submit a manufacturer invoices certifying the actual cost of the item. Except in limited cases, a hearing aid is to be purchased only once in five years. A significant change in hearing (at least 15dBHL, change in at least one frequency between 500 and 400 Hz) will be considered as justification for a new hearing aid on an individual basis. Specialty listening devices such as an FM system will be reviewed on a case-by-case basis. In all cases, a beneficiary/family member and professional fitting the hearing aid must sign and submit documentation within the initial 30 day trial period that answers the following questions: Has the device been used in the beneficiary's living/school/work environment, and is it meeting the needs for each of the applicable environments? Has the device provided a benefit that was not obtained with traditional hearing aids? If so, describe the benefits. Binaural Hearing Aid Requirements Payments for binaural hearing aids will only be considered when the Physician submits justification on why binaural hearing aids have a medically necessary application that cannot be met with one hearing aid. For example, a person who has uncorrectable blindness and a severe hearing loss would have no means other than binaural hearing aids to detect where sound from a potential danger is coming from. Blindness is defined as visual acuity of 20/200 or less in the better eye with the use of corrective lens; or visual field limitation such that the widest diameter of the field subtends an angle no greater than 20 degrees. This finding is equivalent to having a critical visual acuity of 20/200 or less. Guarantee Hearing aids must be unconditionally guaranteed for both parts and service for a period of one year from the date on which the aid is provided to the beneficiary. Replacement Replacement hearing aids will be covered only when the current device no longer meets the beneficiary's needs, has been lost or has been damaged beyond repair. For a hearing aid that no longer meets the beneficiary's need, the provider shall document to significant change in the beneficiary's hearing loss to warrant the replacement. For a hearing aid that has been lost, stolen, or damaged beyond repair, the provider shall document: The disposition of the prior hearing aid and statement of circumstances of loss or damage; In the case of damage, a statement from the hearing aid dealer or audiologist that the hearing aid cannot be repaired; The measures to be taken by the beneficiary, family, or other caregiver to prevent future loss or damage. Long Term Care Residents All requests for hearing aids for beneficiary's residing in Nursing Facilities, and Intermediate Care Facilities must be accompanied by a statement from the Administrator or Director of Nurses which answers the following questions: Has the beneficiary been wearing a hearing aid? If so, how long? Do you believe that this beneficiary will use a hearing aid if Medicaid authorizes the purchase of a hearing aid? Are you of the opinion that this beneficiary will derive sufficient social/medical benefits to justfy the purchase of a hearing aid? Click here for a PDF version of the Director of Nurses Statement for Hearing Aids form. Hearing Aid Repairs and Custom Ear Molds The allowance for hearing aid repairs is provided to cover the expenses of postage, insurance, and the use of another aid while the repair is being completed. There are set rates for standard office and manufacturer repairs, recasing, and an option for repair cost plus set mark-up when a repair will cost more than the set amount, but still be less than a replacement hearing aid. In no instance will a hearing aid repair be paid that occurred within the one year guarantee period other than reduced cost replacement. Payment The Medicaid program will make payment for hearing aids on the following basis: The allowance for monaural and binaural hearing aids will be based on standard fees set by EOHHS. Assistive listening devices (such as FM systems) and specialty aids (such as Bone Conduction aids) will be reimbursed at manufacturer's cost plus a mark-up only after the receipt of the beneficiary/family member and professional statements signifying acceptance of the devices. Prior authorization for these devices will be conditional upon receipt of these statements. Click here for an approved PDF version of the Hearing Aid coverage guidelines. Cochlear Implants Click here for an approved PDF version of the Cochlear Implants coverage guidelines. High Frequency Chest Wall Oscillation Device Airway clearance devices assist beneficiaries with respiratory disorders characterized by excessive respiratory secretions and impaired airway clearance. Devices are available that increase airway resistance to expiratory airflow to promote mucous clearance as well as oscillating or vibratory devices that combine high-frequency airflow with positive expiratory pressure. Coverage and Payment Policy This service requires prior authorization. High frequency chest wall oscillation devices are covered for beneficiaries who meet: A. Criterion 1, 2, or 3, and B. Criterion 4 There is a diagnosis of cystic fibrosis. There is a diagnosis of bronchiectasis which has been confirmed by a high resolution, spiral, or standard CT scan and which is characterized by: a. Daily productive cough for at least 6 continuous months; or b. Frequent (i.e., more than 2/year) exacerbations requiring antibiotic therapy. Chronic bronchitis and chronic obstructive pulmonary disease (COPD) in the absence of a confirmed diagnosis of bronchiectasis do not meet criterion. The beneficiary has one of the following neuromuscular disease diagnoses: Post-polio Acid maltase deficiency Anterior horn cell diseases Multiple Sclerosis Quadriplegia Hereditary muscular dystrophy Myotonic disorders Other myopathies Paralysis of the diaphragm There must be a well-documented failure of standard treatments to adequately mobilize retained secretions. Initial approval will be for a rental period of 90 days. Requests for continued device usage must be accompanied by clinical documentation of stabilization or improvement during the initial 90 day use period. Click here for an approved PDF version of the High Frequency Chest Wall Oscillation Device coverage guidelines. Home Infusion Therapy Home Infusion Therapy (HIT) Services involves the administration of medication through a needle or catheter. It is prescribed when a beneficiary's condition cannot be treated effectively with oral medication or when adequate nutrition cannot be achieved by oral intake. Typically "infusion therapy" is administered intravenously; however other routes such as epidural or intestinal catheters may also be used. Coverage and Payment Policy HIT services are covered if it is beneficial for the beneficiary in lieu of hospitalization. The beneficiary's condition must be stable and not require medical supervision. If intervention is required at any time during the course of therapy, the beneficiary and/or family must fully understand what is required and be willing to cooperate. The prescribing provider must indicate on the CMN, prescription pad, or letter, the diagnosis, the duration of therapy, medication prescribed and the method of infusion. Click here for an approved PDF version of the Home Infusion Therapy coverage guidelines. Infusion Pumps An external infusion pump (stationary or ambulatory) is necessary for the administration of certain medications or nutritional solutions requiring controlled flow rates for specific time periods. An infusion pump will be covered when one of the following criteria is met and documentation described below is submitted: Medications: The prescriber has determined that the infusion of the drug is appropriate for at least one of the following reasons: a. Infusion is more effective than oral or injectable form. b. Medication is not available in an oral formulation. c. Medication cannot be tolerated orally. Parenteral Nutrition Therapies: a. The beneficiary has a medical condition that prohibits adequate oral intake of nutrients and otherwise meets RI Medicaid requirements for parenteral nutrition therapy. Enteral Nutrition Therapy: a. The beneficiary has a functioning gastrointestinal tract but with inability to ingest or tolerate oral intake. Note: Above services are not covered if experimental, investigational, or part of a clinical trial. Coverage and Payment Policy: Prior authorization is required. All requests for external infusion pumps require the completion and submission of a RI Certificate of Medical Necessity for External Infusion Pump. An infusion pump and related enteral or parenteral products/supplies will be covered as medically necessary when: Upon documentation of the appropriateness of the therapy and of the prescribed pump for the beneficiary. A prescribing provider's prescription and supporting documentation to show medical necessity must be included in the documentation submitted. Documentation that the beneficiary is capable of managing the infusion process or that a caregiver will be available to manage the process. Documentation that the beneficiary is clinically stable and does not require hospitalization. Click here for an approved PDF version of the Infusion Pump coverage guidelines. Hospital Beds A hospital bed allows adjustments to the head and leg elevation and can support or accommodate special attachments. Ordinary beds are typically sold as furniture and do not meet the definition of a hospital bed or durable medical equipment (DME). The purpose of these guidelines is to provide detailed coverage criteria for hospital beds and summarizes the types of hospital beds covered and the clinical documentation required to support the medical necessity for each type of hospital bed. These guidelines pertain to adults only in the Medicaid program. Hospital bed types: Fixed Height: allows manual adjustment to head and leg elevation but not to height. Variable Height: allows manual adjustment to head and leg elevation and to height. Semi electric: allows for manual adjustment and electric adjustment to head and leg elevation Total electric: allows electric adjustments to height, and to head and leg elevation. Coverage and Payment Policy Prior authorization is required. All requests for hospital beds require completion and submission of a RI Certificate of Medical Necessity for hospital beds. The DME provider must submit any and all clinical documentation with prior authorization request as necessary. Coverage Requirements: These criteria include, but are not limited to, the following for each type of hospital bed listed below: Fixed Height: requires one or more of the following: a. Beneficiary has a medical condition that requires positioning the body in ways not feasible with an ordinary bed (elevation of the head or body to 30 degrees or less does not meet this criterion); b. Beneficiary requires positioning the body in ways not feasible with an ordinary bed in order to alleviate pain; c. Beneficiary requires head or upper body elevation of greater than 30 degrees and pillows or wedges have been tried and failed as a solution; d. Beneficiary requires traction or other equipment that can only be applied to a hospital bed. Variable Height: beneficiary meets one of the criteria for a fixed height hospital bed and requires a bed height different from a fixed height hospital bed to permit transfers. Semi-electric: beneficiary meets one of the criteria for a fixed height hospital bed and requires frequent or immediate changes in body position and is able to operate the bed controls. Total electric: beneficiary meets the criteria for a variable height hospital bed and semi-electric hospital bed, and it is the least costly medical alternative. Heavy duty/extra wide: beneficiary must meet one of the criteria for a fixed-height hospital bed and weigh more than 350, but does not exceed 600 pounds. Extra heavy duty/extra wide: beneficiary must meet one of the criteria for a fixed height hospital bed and weight exceeds 600 pounds. Enclosed Bed Systems An enclosed bed system is a specialized bed that has been manufactured or customized with additional protection and/or enclosure components. These beds can be fully or partially enclosed with zippered mesh panels or fabricated with wooden or metal side panels or side rails with interior padding that may only be removed from the outside, and include other safety components. Other enclosed beds components include those which provide ventilation, manual or electric height adjustability, head and/or lower extremity elevation, and for respiratory and feeding purposes. Due to the restrictive nature of an enclosed bed use of a specialized bed with protective components should only be considered after it has been determined that all available and less restrictive alternatives have been ineffective in maintaining the safety of the beneficiary. Protective or enclosure beds are medically necessary for individuals especially susceptible to harm from injury by exiting the bed unsafely and are unable to use a less intensive and restrictive alternative. Coverage determinations are based on an individual assessment of the beneficiary and his or her clinical needs. Enclosed Bed Systems may be considered clinically appropriate when the beneficiary meets all of the following criteria and documentation submitted for review: The beneficiary has one of the following diagnoses: a. Traumatic Brain Injury b. Cerebral Palsy c. Seizure Disorder d. Severe Behavioral Disorder, AND There is cognitive and communication impairment, AND There is documentation of medical necessity that includes at least one of the following: a. Daily tonic-clonic seizure activity b. Uncontrolled perpetual movement related to diagnosis c. Self-injurious behavior, such as head banging, where a helmet was tried and failed, AND The person demonstrates unsafe mobility, including mobility that will put the individual at risk for serious injury, not just a possibility of injury (e.g., climbing out of bed, not just standing at the side of the bed) AND There is documentation regarding this person's history of injuries related to this request; AND There is documented evidence of a proven safety risk despite use of multiple, less invasive strategies and less costly alternatives have been tried and demonstrated to be ineffective. In general, Enclosed Bed Systems are not considered clinically appropriate: For adults who suffer from confusion or dementia When the purpose is to restrain a person due to behavioral conditions Accessories: A trapeze bar is covered when a beneficiary needs this device to sit up because of a respiratory condition, to change body position for other medical reasons or to get in or out of bed. A trapeze bar is covered when it is either an integral part of or used on a hospital bed, and it has been determined that both the hospital bed and the trapeze bar are medically necessary. Heavy duty trapeze equipment is covered if the beneficiary meets the criterial for regular trapeze equipment and the beneficiary's weight is more than 250 pounds. A bed cradle is covered when it is necessary to prevent contact with the bed coverings. Side rails or safety enclosures are covered when they are required by the beneficiary's condition and they are an integral part of, or an accessory to, a covered hospital bed. Click here for an approved PDF version of the Hospital Bed coverage guidelines. All requests for Enclosed Beds require the completion and submission of a Certificate for Medical Necessity for Enclosed Beds. Incontinence Appliances and Care Supplies Indications Incontinence appliances and supplies are covered for the recipients who have a condition which impairs proper bladder function and requires physical intervention. Coverage and Payment Policy Indwelling Catheters, Foley Type, Two-Way No more than two catheters per month are covered for routine catheter maintenance. Nonroutine catheter changes are covered when documentation substantiates medical necessity, such as for the following indications: Catheter is accidentally removed (e.g., pulled out by patient) Malfunction of catheter (e.g., balloon does not stay inflated, hole in catheter) Urine Leaks around catheter Catheter is obstructed by encrustation or mucous plug Urinary tract infection Hematuria with obstruction due to clots History of recurrent obstruction or infection for which it has been established that an acute event is prevented by a scheduled change at more than twice monthly intervals. Intermittent catheters will be covered. Catherization kits are covered in those instances where a sterile working area is required. Supplies included in the treatment of incontinence are gloves, sterile lubricants, barrier fields. In those instances where the recipient requires more supplies than are normally covered under the Medical Assistance Program, a Prior authorization stating the medical necessity of the increased need may be submitted for consideration. Intermittent Positive Pressure Breathing Device Coverage and Payment Policy This service requires prior authorization and is continuously rented. This device will be covered when specific clinical situations outlined below are documented and condition persists after trial of pharmacological and other conventional therapies. Requesting prescriber must submit: A. Documentation of one of the following conditions: Beneficiary is at risk of respiratory failure because of decreased respiratory function secondary to kyphosis or neuromuscular disorders Beneficiary has documented severe bronchospasm or exacerbation of obstructive pulmonary disease (COPD) and has failed to respond to standard therapies. Beneficiary has atelectasis which has not responded to other therapies. B. Attestation by prescriber that condition persists after trial of standard therapies. Click here for an approved PDF version of the Intermittent Positive Pressure Breathing Device coverage guidelines. Lymphedema Pumps Lymphedema is the swelling of subcutaneous tissues due to the accumulation of excessive lymph fluid resulting from impairment of the normal clearing function of the lymphatic system. Examples of causes of lymphedema are: tumor obstruction of lymph nodes or post radiation fibrosis. Pneumatic devices are covered in the home setting if the patient has undergone conservative treatment for at least 4 weeks without improvement. Conservative treatment must include elevation, use of appropriate compression bandage or garment and exercise. Pneumatic compression devices are covered in the home setting for the treatment of chronic venous insufficiency (CVI) of the lower extremities only if the patient has one or more venous stasis ulcer(s) which have failed to heal after a 6 month trial of conservative therapy directed by the treating physician. The trial of conservative therapy must include a compression bandage system or compression garment, appropriate dressings for the wound, exercise, and elevation of the limb. Coverage and Payment Policy This service requires prior authorization. The prescribing provider must submit the following documentation: Supporting diagnosis for cause of lymphedema. Examination by requesting physician within 30 days of request for the lymphedema pump. Clinical attestation that patient or caregiver are capable of managing the device. Recommended pressure, frequency and duration information. Supplies used in conjunction with the lymphedema pump are covered. Click here for an approved PDF version of the lymphedema pump coverage g Minor Environmental Modifications Minor Environmental Modifications (Minor Assistive Devices) may include grab bars, versa frame (toilet safety frame), hand held shower and or diverter valve, raised toilet seats, and other simple devices or appliances such as eating utensils, transfer bath bench, shower chair, aids for personal care (e.g. reachers) and standing poles to improve home accessibility adaptation, health or safety. Minor Environmental Modifications (GW-AD1) Nebulizers/Supplies The use of various types of nebulizers, compressors and approved inhalation solutions of required medications may be clinically necessary in situations where conventional routes of medication administration have failed to achieve the needed result. The following may be approved in such circumstances: Small volume nebulizer Large volume nebulizer Related compressor Related medication Small volume ultrasonic nebulizer and accessories (prior authorization required) Coverage and Payment Policy A small volume nebulizer and compressor are covered when: It is reasonable and necessary to administer appropriate medications for management of Obstructive Pulmonary Disease; or It is reasonable and necessary to administer appropriate medication for Cystic Fibrosis; or It is reasonable and necessary to administer appropriate medication for Bronchiectasis; or It is reasonable and necessary to administer medication for HIV, Pneumocystosis, or complications of organ transplant; or It is reasonable and necessary to administer medications to manage tenacious pulmonary secretions. A large volume nebulizer, compressor and water or saline are covered when: It is reasonable and necessary to administer humidity to a beneficiary with thick, tenacious secretions who has Cystic Fibrosis, Bronchiectasis, a tracheostomy or a tracheobronchial stent. A small volume ultrasonic nebulizer and related accessories will be covered (prior authorization required) when: It is reasonable and necessary to administer treprostinil; and Documentation of pulmonary hypertension not secondary to pulmonary venous hypertension, disorders of the respiratory system; and Documentation of pulmonary hypertension secondary to connective tissue disease, thromboembolic disease of the pulmonary arteries, HIV or congenital left to right shunts; and The condition has progressed despite conventional therapies; and Mean pulmonary artery pressure is >25 mm Hg at rest or >30 mm with exertion; and The beneficiary has significant pulmonary hypertension related symptoms. If none of the drugs used with a nebulizer are covered, the compressor, the nebulizer, and other related accessories/supplies will be denied as not reasonable and necessary. A nebulizer and compressor will not be approved for use with compounded or non FDA approved medications. Click here for an approved PDF version of the Nebulizer coverage guidelines. Negative Pressure Wound Therapy Coverage and Payment Policy Negative Pressure Wound Therapy (NPWT) is the application of sub-atmospheric pressure to a wound in order to remove exudate and debris from the wounds. NPWT is delivered through a system which includes a suction pump, exudate collection chamber and dressing sets. This service requires prior authorization. The prescribing provider must submit the following information: A. Ulcers and Wounds in the Home Setting: The beneficiary has a chronic Stage III or IV pressure ulcer, neuropathic (for example, diabetic) ulcer, venous, or arterial insufficiency ulcer. A complete wound therapy program described by criterion 1 and criteria 2, 3, or 4, must have been tried or considered and ruled out prior to application of NPWT. For all ulcers and wounds, the following components of a wound therapy program must include all of the following measures which should be addressed, applied, or considered and ruled out prior to application of NPWT. a. Documentation in the beneficiary's medical record of evaluations, care, and wound measurements by a licensed medical professional, and b. Application of dressing to maintain a moist wound environment, and c. Debridement of necrotic tissue if present, and d. Evaluation of and provision for adequate nutritional status. For Stage III and IV pressure ulcers: a. The beneficiary has been appropriately turned and positioned, and b. The beneficiary has used a group 2 or 3 support surface for ulcers on the back or pelvis, and c. Moisture and incontinence have been properly managed. For neuropathic (for example, diabetic) ulcers: a. The beneficiary has been on a comprehensive diabetic management program, and b. Reduction in pressure on a foot ulcer has been accomplished with appropriate modalities. For venous insufficiency ulcers: a. Compression bandages and/or garments have been consistently applied, and b. Leg elevation and ambulation have been encouraged. B. Ulcers and Wounds encountered in an Inpatient Setting: The beneficiary has complications of a surgically created wound (for example, dehiscence) or a traumatic wound (for example, pre-operative flap or graft). Continued Coverage In order for coverage of NPWT to continue, a licensed medial professional must submit the following: On at least a monthly basis, document changes in the ulcer's dimensions and characteristics. Exclusions from Coverage Presence of necrotic tissue with eschar if debridement has not been attempted; or Presence of osteomyelitis in area of wound without treatment with intent to cure; or Cancer in the wound; or Presence of an open fistula to an organ or body cavity within the vicinity of the wound. Click here for approved PDF version of the Negative Pressure Wound Therapy coverage guidelines. Orthopedic and Therapeutic Shoes Coverage and Payment Policy Orthopedic shoes are designed to accommodate specific foot deformities and must include attachment to a brace. Diabetic shoes are designed to reduce the likelihood of blisters, sores and chafing occurring by creating an environment within the shoe that has sufficient room for movement, while inhibiting pressure and abrasive points. Custom molded shoes are covered only if the standard shoe cannot accommodate a foot anomaly. This service requires prior authorization. Coverage is for one pair of shoes per twelve calendar months. For beneficiaries meeting the coverage criteria for therapeutic shoes, three (3) pairs of inserts are covered within the same twelve calendar months. Request for additional shoes within the specified time frame will be reviewed for medical necessity on a case-by-case basis. Orthopedic shoes require the following documentation: Prescription signed and dated by the prescribing provider; and Certification by the prescribing provider that the shoe must be attached to a brace. Therapeutic shoes require the following documentation: Diabetic shoes require a diagnosis of diabetes and a Certificate of Medical Necessity for Diabetic Shoes signed and dated by the prescribing provider; and Certifies that the beneficiary is being treated under a comprehensive plan of care for his/her diabetes and that he/she needs therapeutic shoes; and Prescribing provider documents the beneficiary has one or more of the following conditions: Previous amputation of the foot or part of the foot due to complications that resulted from diabetes; History of previous foot ulceration; Pre-ulcerative callus formation, or peripheral neuropathy with a history of callus formation; Foot deformity; Poor circulation; Increased callus formation; Increased peripheral neuropathy; or Significant worsening or change of a foot deformity. Custom molded shoes require the following documentation: Prescription signed and dated by the prescribing provider; and The prescribing provider documents as to why standard shoes will not be adequate and/or why the depth of standard shoes cannot accommodate a foot anomaly. Click here for approved PDF version of the Orthopedic and Therapeutic Shoes coverage guidelines. Orthotic and Prosthetic Devices Orthotics are mechanical devices intended to support or correct a defect or deformity or to improve the function of movable parts of the body and are generally referred to as a "brace" or "orthosis". Prosthetic devices are non-dental artificial substitutes for a missing body part. The Orthotic/Prosthetic may be covered for beneficiaries when the following criteria are met: The beneficiary has a medical condition that results in the need for an orthotic/prosthetic to: artificially replace a missing portion of the body; prevent or correct physical deformity or malfunction; or to support a weak or deformed portion of the body. When the device is prescribed by a licensed medical provider operating within their scope of practice, and who is knowledgeable in the use of prosthetics/orthotics, and who provides medical care to the beneficiary. Requests for replacement or modified devices will be reviewed on a case by case basis. Click here for an approved PDF version of the Orthotic and Prosthetic Device coverage guidelines. Osteogenic Stimulators Osteogenic stimulators promote bone formation and fracture healing. Non-spinal electrical osteogenesis stimulator: Non-union of a long bone fracture defined as radiographic evidence that fracture healing has ceased for three or more months; or Failed fusion of a joint other than in the spine where minimum of nine months has elapsed since the last surgery; or Congenital pseudoarthrosis. Spinal electrical osteogenesis stimulator: Failed spinal fusion where a minimum of nine months has elapsed since the last surgery; or Following a multilevel spinal fusion surgery; Following spinal fusion surgery where there is a history of a previously failed spinal fusion at the same site. Coverage and Payment Policy This service requires prior authorization. The prescribing provider must submit the following documentation: a. Prescribing clinician must have completed a face to face evaluation within 90 days of submitting the request. b. If request is for a replacement or modification of equipment a current face to face evaluation is required. c. Attestation that appropriate radiographs have been taken and that full interpretation is included in the clinical record. d. Brief description of the fracture or required surgery. Click here for an approved PDF version of the Osteogenesis Stimulators coverage guide Ostomy Supplies Indications Ostomy supplies are covered for use on patients with an ostomy. Coverage and Payment Policy There is seldom medical necessity for closed colostomy or ileostomy pouches rather than drainable pouches. The medical necessity of a closed pouch must be well documented in the recipient's medical record. When a liquid barrier is necessary, either liquid or spray or individual wipes would be appropriate. The use of both would not be medically necessary. Recipients with continent stomas may use the following means to prevent/manage drainage: stoma cap, stoma plug, or gauze pads. No more than one type of supply would be medically necessary on a given day. Recipients with urinary ostomies may use either a bag or bottle for drainage at night. It is not medically necessary to have both. When a drainage bag is used with urinary ostomies, more than one per month would rarely be medically necessary. Provision of ostomy supplies should be limited to a one-month supply. Oximeters Coverage and Payment Policy Pulse oximetry, expressed as SaO2, is a method of measuring the oxygen saturation of the blood in order to provide information required for monitoring the effectiveness or adjustment of oxygen therapy. This service requires prior authorization. The prescribing provider must submit the following information: A. Short term use of oximetry: (less than 10 months) When weaning a beneficiary from home oxygen therapy; or When a change in the beneficiary's physical condition while on oxygen therapy requires a change in the prescribed oxygen flow rate; or To determine the beneficiary's oxygen requirement during ambulation, exercise or sleep; or To determine the appropriate oxygen flow requirement; or To determine the appropriate home oxygen for beneficiaries with neuromuscular disease involving muscles of respiration, with chronic lung disease, or with severe cardiopulmonary disease; And A trained caregiver or the beneficiary is capable of adjusting oxygen flow as prescribed. B. Long term use: (10 months or longer) The beneficiary has a tracheostomy or uses a ventilator and requires monitoring; And A trained caregiver or the beneficiary is capable of adjusting oxygen flow as prescribed. Click here for an approved PDF version of the Oximeter coverage guidelines. Oxygen And Oxygen Equipment Coverage and Payment Policy Coverage of home oxygen therapy is available only for beneficiaries with significant hypoxemia in the chronic stable state, provided the following conditions are met: The attending or consulting physician has determined that the beneficiary suffers a severe lung disease or hypoxia-related symptoms that might be expected to improve with oxygen therapy; The beneficiary's blood gas levels indicate the need for oxygen therapy; and Alternative treatment measures have been tried or considered and been deemed clinically ineffective. The treating physician or a qualified provider or supplier of laboratory services conducted the qualifying blood gas study. A qualified provider or supplier of laboratory services: Certified to conduct blood gas studies or A hospital certified to conduct blood gas studies A DME provider is not considered a qualified provider or supplier of laboratory services for purposed of these guidelines. The qualifying blood gas study value was obtained under these conditions: During an inpatient stay-closest to, but no earlier than, 2 days prior to the hospital discharge date, with home oxygen therapy beginning immediately following discharge, or During an outpatient encounter-within 30 days of the date of Initial Certification while the beneficiary is in a chronic stable state, which is when the beneficiary is not in a period of acute illness or an exacerbation of his or her underlying disease. Group I criteria: Beneficiary on room air while at rest (awake) when tested: Arterial oxygen saturation is at or below 88 percent or Arterial Partial Pressure of Oxygen (PO2) is at or below 55 mm Hg Beneficiary tested during exercise and, if during the day while at rest, arterial PO2 is at or above 56 mm Hg or an arterial oxygen saturation is at or above 89 percent: Arterial PO2 is at or below 55 mm Hg or an arterial oxygen saturation is at or below 88 percent and Documented improvement of hypoxemia during exercise with oxygen Beneficiary tested during sleep and if arterial PO2 is at or above 56 mm Hg or an arterial oxygen saturation is at or above 89 percent with awake, additional testing must show: Arterial PO2 is at or below 55 m Hg or an arterial oxygen saturation is at or below 88 percent for at least 5 minutes taken during sleep or Decrease in arterial PO2 of more than 10 mm Hg or a decrease in arterial oxygen saturation more than 5 percent for at least 5 minutes associated with symptoms or signs more than 5 percent from baseline saturation for at least 5 minute take during sleep associate with symptoms or signs reasonably attributable to hypoxemia. Group II criteria: Beneficiary on room air at rest with awake when tested: Arterial oxygen saturation of 89 percent at rest (awake) or Arterial PO2 of 56-59 mm Hg and a. Dependent edema suggesting congestive heart failure or b. Pulmonary hypertension or cor pulmonale or c. Erythocythemia with hematocrit greater than 56 percent or Beneficiary tested during exercise: Arterial oxygen saturation of 89 percent or Arterial PO2 of 56-59 mm Hg and a. Dependent edema suggesting congestive heart failure b. Pulmonary hypertension or cor pulmonale or c. Erythocythemia with hematocrit greater than 56 percent Beneficiary tested during sleep for at least 5 minutes: Arterial oxygen saturation of 89 percent or Arterial PO2 of 56-59 mm Hg and a. Dependent edema suggesting congestive heart failure b. Pulmonary hypertension or cor pulmonale or c. Erythocythemia with a hematocrit greater than 56 percent Portal Oxygen: A beneficiary meeting the above requirements may qualify for a portable oxygen system. The prescriber must document that the beneficiary's activities take him or her beyond the functional limits of the stationary system. Spare tanks of oxygen are denied as not medically necessary, since these items are precautionary and not therapeutic in nature. Oxygen equipment is continuously rented and all supplies (e.g., mask, tubing, etc.) are included in the rental fee. There is no separate payment for fills (either gaseous or liquid) unless the equipment is owned by the beneficiary, the only fills are covered, and no rental of equipment. Reasons for Noncoverage: Angina pectoris in the absence of hypoxemia; Breathlessness without cor pulmonale or evidence of hypoxemia; Peripheral vascular disease resulting in desaturation in one of more extremities without evidence of central hypoxemia; and Terminal illness that does not involve the lungs. Effective 7/1/2019, Face to Face requirement can be found here. Oxygen Certificate of Medical Necessity can be found here. Click here for an approved PDF version of the Oxygen and Oxygen Equipment guideline. Portable Oxygen Systems Coverage of a portable oxygen system alone or to complement a stationary oxygen system may be allowed if the recipient meets the criteria for oxygen and ambulation outside the home is necessary. Spare tanks of oxygen or emergency oxygen inhalators are denied as not medically necessary, since these items are precautionary and not therapeutic in nature. Initial Claim The prior authorization for oxygen therapy must also include the results of a blood gas study that has been ordered and evaluated by the attending, or consulting, physician. This will usually be in the form of a measurement of the partial pressure of oxygen (PO2) in arterial blood. A measurement of pulse arterial oxygen saturation may also be acceptable when ordered and evaluated by the attending physician and performed under his or her supervision or when performed by a qualified provider or supplier of laboratory services. A DME supplier is not considered a qualified provider or supplier of laboratory services for purposes of these guidelines. Laboratory Tests The conditions under which the laboratory tests are performed must be specified in writing and submitted with the initial claim. Examples of this documentation may include: at rest, while sleeping, while exercising on room air or, if while on oxygen, the amount, body position during testing, and similar information necessary for interpreting the evidence. In those instances where less than one liter or more than four liters is required, a modifier should be used for proper payment. Oxygen equipment is continuously rented and all supplies (e.g., mask, tubing, etc) are included in the rental fee. There is no separate payment for fills (either gaseous or liquid) unless the equipment is owned by the recipient. Then only fills are covered, no rental of equipment. Patient Lifts A Patient Lift is covered if transfer between bed and a chair, wheelchair, or commode is required and, without the use of a lift, the beneficiary would be bed confined. Coverage and Payment Policy This service requires prior authorization. a. Submitted information must include attestation to a diagnosis that prevents the member from transferring without assistance or that requires more than one person to assist for transfer. b. A multi-positional patient transfer system is covered if the above criteria is met and the beneficiary requires supine positions for transfers. c. Only one type of lift will be covered unless medical documentation can show a need for two lifts. Click here for an approved PDF version of the Patient Lift coverage guidelines. Percussor Indications A percussor is covered in order to mobilize respiratory secretions is those recipients with chronic obstructive lung disease, chronic bronchitis or emphysema. Coverage and Payment Policy The physician must indicate on the CMN the medical condition of the recipient and that the recipient or caregiver has received appropriate training by a physician or therapist and manual therapy is inappropriate. Prior authorization is required. Phototherapy Indications Phototherapy is covered for those recipients who have a diagnosis of Hyperbilirubinemia and who require phototherapy for treatment. Coverage and Payment Policy Prior authorization is required. Physician must indicate the duration of therapy required. Phototherapy for Behavioral Health Coverage and Payment Policy Phototherapy for Behavioral Health is defined as use of a high intensity light box or bright light therapy for the treatment of specific disorders. This policy does not address metabolic use of specific light therapies for disorders such as neonatal hyperbilirubinemia or for dermatologic or other physical diagnosis. This services requires prior authorization. The prescribing provider must submit the following documentation: Beneficiary must have a documented diagnosis of a major depressive disorder, bi-polar disorder, or seasonal affective disorder with a temporal relationship to a particular time of the year (ex: winter depression with onset in fall/winter and remission in the spring). Click here for an approved PDF version of the Phototherapy for Behavioral Health coverage guidelines. Positive Pressure (PAP) Devices Continuous Positive Airway Pressure (CPAP) therapy utilizes equipment to deliver a constant level of positive air pressure into the throat to prevent the collapse of the airway during inhalation. This is done by tubing and a noninvasive interface such as nasal, oral, or face mask. Bi-level Positive Airway Pressure (BiPAP) therapy delivers adjustable, variable levels within a single respiratory cycle of positive air pressure by way of tubing and a noninvasive interface to assist spontaneous respiratory efforts and supplement the volume of inspired air. A CPAP will be covered for beneficiaries who meet the following criteria: Diagnosis of Obstructive Sleep Apnea (OSA) Accredited facility based polysomnogram that meets the following criteria a. Apnea-Hypoxia Index (AHI) or Respiratory Disturbance Index (RDI) is greater than or equal to 15 events per hour; or b. AHI or RDI between 5 to 14 events per hour with documented: i. Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or ii. Hypertension, ischemic heart disease, or history of stroke. A BiPAP will be covered for beneficiaries who meet criteria listed above and who in addition have documentation from the treating physician of one of the following: Unsuccessful 3 month trial on a CPAP device Beneficiary is unable to tolerate CPAP Documentation must include a facility based polysomnogram with minimum two hour duration without use of a CPAP or BiPAP device. Coverage and Payment Policy CPAP and BiPAP require prior authorization. Payment for the rental of Positive Airway Pressure Devices includes payment for the provision of all necessary accessories; i.e., mask tubing or cannula. Separate charges for replacement of masks, tubing or cannula, or for respiratory equipment maintenance services, are not covered since they are included in the rental payment for CPAP/BiPAP. Initial Approval: Initial approval is for a period of three months. BiPAP and CPAP devices are approved for rental only. Renewal Approval: Renewal approval requires that between day 31 and day 90 of device use the treating physician shall determine that the beneficiary is continuing to use the device; and The treating physician must attest to the continued need for the device. A repeat polysomnogram is not required. Renewal approval may be requested up to 10 months. At the end of the 10th month, the equipment will be considered purchased and no further monthly billing shall occur. Replacement: If the PAP device is replaced because of loss, theft, or irreparable damage due to a specific incident, there must be a face to face evaluation by the treating physician that documents the continued need and use of the device. A repeat polysomnogram may be required if there have been significant changes in clinical diagnosis. Click here for an approved PDF version of the Positive Airway Pressure (PAP) Devices coverage guidelines. Power Operated Vehicle Indications A power operated vehicle (POV) is covered when all of the following criteria are met: The recipient’s condition is such that a wheelchair is required for the recipient to get around and; The recipient is unable to operate a manual wheelchair, The recipient is capable of safely operating the controls for the POV, The recipient can transfer safely in and out of the POV, and has adequate trunk stability to be able to safely ride in the POV. Medical justification shows that a power operated vehicle is more beneficial for the recipient's care than a motorized wheelchair. Coverage and Payment Policy A POV that is beneficial primarily in allowing the recipient to perform leisure or recreational activities will be denied as not medically necessary. A POV will be covered in lieu of a wheelchair. Pressure Reducing Support Surfaces - Group 3 Pressure Reducing Support Surfaces - Group 1 Group 1 support surfaces are generally designed to either replace a standard hospital or home mattress or as an overlay placed on top of a standard hospital or home mattress. Products in this Category include non-powered pressure reducing mattresses, pressure pads and mattress overlays (foam, air water, or gel). A Group 1 mattress overlay or mattress is covered if one of the following three criteria is met: 1. The beneficiary is completely immobile- i.e., beneficiary cannot make changes in body position without assistance, or 2. The beneficiary has limited mobility - i.e., beneficiary cannot independently make changes in body position significant enough to alleviate pressure and at least one of the conditions A-D below. 3. The beneficiary has any stage pressure ulcer on the trunk or pelvis and at least one of the conditions A-D below. A. Impaired nutritional state B. Fecal or urinary incontinence C. Altered sensory perception D. Compromised circulatory status Coverage and Payment Policy This service does not require prior authorization. Click here for an approved PDF version of the Pressure Reducing Support Surfaces Group 1 policy. Pressure Reducing Support Surfaces - Group 2 Group 2 support surfaces are generally designed to either replace a standard hospital or home mattress or as an overlay placed on top of a standard hospital or home mattress. Products in this category include powered air flotation beds, powered pressure reducing air mattresses, and non-powered advanced pressure reducing mattresses. A Group 2 support surface is covered if the beneficiary meets at least one of the following three criteria (1, 2, or 3): 1. The beneficiary has multiple stage II pressure ulcers located on the trunk or pelvis which have failed to improve over the past month, during which time the beneficiary has been on a comprehensive ulcer treatment program including each of the following: a. Use of an appropriate Group 1 support surface, and b. Regular assessment by a nurse, physician, or other licensed healthcare practitioner, and c. Appropriate turning and positioning, and d. Appropriate wound care, and e. Appropriate management of moisture/incontinence, and f. Nutritional assessment and intervention consistent with the overall plan of care 2. The beneficiary has large or multiple stage III or IV pressure ulcers(s) on the trunk or pelvis 3. The beneficiary has a myocutaneous flap or skin graft for a pressure ulcer on the trunk or pelvis within the past 60 days and has been on a Group 2 or 3 support surface immediately prior to discharge from a hospital or nursing facility within the past 30 days. If the beneficiary is on a group 2 support surface, there should be a care plan established by the treating physician or home care nurse which includes the above elements. Coverage and Payment Policy This service requires prior authorization. The continued use of a group 2 support surface is covered until the ulcer is healed and must be documented by the treating physician every 3 months. Certificate of Medical Necessity for Support Surfaces is required. Click here for an approved PDF version of the Pressure Reducing Support Surfaces Group 2 policy. Pressure Reducing Support Surfaces - Group 3 Group 3 support surfaces are complete bed systems, known as air fluidized beds, which use the circulation of filtered air through silicone beads. A Group 3 support surface is covered only if all of the following criteria are met: 1. The beneficiary has a stage III (full thickness tissue loss) or stage IV (deep tissue destruction) pressure ulcer. 2. The beneficiary is bedridden or chair bound as a result of severely limited mobility. 3. In the absence of an air-fluidized bed, the beneficiary would require institutionalization. 4. The air fluidized bed is ordered in writing by the beneficiary's attending physician based upon a comprehensive assessment and evaluation of the beneficiary after completion of a course of conservative treatment designed to optimize conditions that promote wound healing. The evaluation must be performed within one month to initiation of therapy with the air-fluidized bed. 5. The course of conservative treatment must have been at least one month in duration without progression toward wound healing. This month of prerequisite conservative treatment may include some period in an institution as long as there is documentation available to verify that the necessary conservative treatment was rendered. Conservative treatment must include: a. Frequent repositioning of the beneficiary with particular attention to relief of pressure over bony prominences (usually every two hours); and b. Use of a Group 2 support surface to reduce pressure and shear forces on healing ulcers and to prevent new ulcer formation; and c. Necessary treatment to resolve any wound infection; and d. Optimization of nutrition status to promote wound healing; and e. Debridement by any means, including wet-to-dry gauze dressings, to remove devitalized tissue from the wound bed; and f. Maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings protected by an occlusive covering, while the wound heals. In addition conservative treatment should generally include: g. Education of the beneficiary and caregiver on the prevention and management of pressure ulcers; and h. Assessment by a physician, nurse, or other licensed healthcare practitioner at least weekly, and i. Appropriate management of moisture/incontinence. 6. A trained adult caregiver is available to assist the beneficiary with activities of daily living, fluid balance, dry skin care, repositioning, recognition and management of altered mental status, dietary needs, prescribed treatments and management and support of the air-fluidized bed system and its problems such as leakage. 7. A physician directs the home treatment regimen, and reevaluates and re-certifies the need for the air-fluidized bed on a monthly basis. 8. All other alternative equipment has been considered and ruled out. Coverage and Payment Policy This service requires prior authorization. The physician must document that the beneficiary has met all of the criteria above. The Certificate of Medical Necessity for Support Surfaces is required. An air-fluidized bed will be denied under any of the following circumstances: 1. The beneficiary has coexisting pulmonary disease (the lack of firm back support makes coughing ineffective and dry air inhalation thickens pulmonary secretions); 2. The beneficiary requires treatment with wet soaks or moist wound dressings that are not protected with an impervious covering such as plastic wrap or other occlusive material; 3. The caregiver is unwilling or unable to provide the type of care required by the beneficiary on an air-fluidized bed; 4. Structural support is inadequate to support the weight of the air-fluidized bed system (if generally weighs 1600 pounds or more); 5. Electrical system is insufficient for the anticipated increase in energy consumption; or 6. Other known contraindications exist. The continued coverage of an air-fluidized bed must be documented by the treating physician every month. Continued use of an air-fluidized bed is covered until the ulcer is healed or if healing does not continue, there is documentation to show that: (1) other aspects of the care plan are being modified to promote healing, or (2) the use of the bed is reasonable and necessary for wound management. Click here for an approved PDF version of the Pressure Reducing Support Surfaces Group 3 coverage guidelines. Prone Standers, Supine Standers, Standing Tables Indications Prone standers, supine standers, standing tables are covered for those recipients who are over two years of age and who require physical restrainment to stand properly. The medical condition must support the need. Coverage and Payment Policy Standers will be covered for those recipients who meet the above requirements. Prior authorization is required. Rollabout, Mobile Geriatric Chairs Indications Rollabout, Mobile Geriatric chairs will be covered for those recipients who have impaired ambulation and require help in transportation. Coverage and Payment Policy Rollabout, Mobile Geriatric chairs will be covered in lieu of a wheelchair. The physician must indicate the need for this type of transportation and that a wheelchair would not be beneficial. Prior authorization required. Seat Lift Chairs/Motorized Mechanisms Coverage and Payment Policy A Seat Lift Mechanism is an assistive device used in the home to lift a person's body from a sitting to a standing position or to lower the individual from a standing to a sitting position. A Seat Lift chair and mechanism are covered if the beneficiary meets all of the criteria listed below: The member must have severe arthritis of the hip or knee or have a severe neuromuscular disease. The seat lift mechanism must be a part of the managing clinician's course of treatment and be prescribed to either effect improvement or arrest deterioration in the beneficiary's condition. The member must be completely incapable of standing up from any chair within the home and Once standing, the beneficiary must have the ability to ambulate. Note: the fact that a member has difficulty or is incapable of getting up from a chair is not sufficient justification for a Seat Lift Mechanism. Coverage is limited to those types of mechanisms that operate smoothly, can be controlled by the member and effectively allow for standing and sitting without other assistance. Excluded from coverage is the type of lift that operates by a spring loaded mechanism with a sudden, catapult-like motion and which jolts the member from a seated to a standing position. The seat lift mechanism and the chair are to be billed separately. Prior Authorization is required. Written approval from Medicare for the mechanism must be submitted with the prior authorization request. Click here for approved PDF version of the Seat Lift Chair and Mechanism coverage guidelines. Speech Generating Devices Speech Generating Devices/Electronic Speech Aids Speech Generating Devices are covered if the beneficiary suffers from severe speech impairment and the medical condition warrants the use of a device. Coverage and Payment Policy Prior Authorization is required. A speech generating device will be covered when all of the following criteria are met and documentation submitted: Prior to delivery of the device the beneficiary has had a formal evaluation of their cognitive and communication abilities by a speech-language pathologist. The written evaluation must include the following: a. Current communication impairment, including the type, severity, language skills, cognitive ability and anticipated course of the impairment; b. An assessment of whether communication needs could be met without use of an assist device; c. A description of the treatment goals; d. Rationale for requesting a specific device and accessories; e. Documentation of a training plan; f. Documentation that the beneficiary is capable of using the device; The beneficiary's speech impairment is one resulting in a severe expressive speech impairment; and The beneficiary's speaking needs cannot be met using natural communication methods; and Other forms of treatment have been considered and ruled out; and The beneficiary's speech impairment will benefit from the device ordered; and The SLP performing the beneficiary evaluation may not be an employee of or have a financial relationship with the supplier of the SGD; and Treating Physician order is required for device and accessories. Artificial larynx or electronic speech aids are covered for a beneficiary with documented laryngectomy or permanently inoperative larynx. Click here for an approved PDF of the Speech Generating Device coverage guidelines. Suction Pumps Suction pumps are electrical aspirator devices designed for upper respiratory oral pharyngeal and tracheal suction or for gastric suction. Upper Airway Use: A respiratory suction pump is a device designed to remove respiratory secretions that cannot be managed by the beneficiary due to compromised cough mechanism or tracheostomy. Coverage and Payment Policy for Respiratory conditions: When a beneficiary has difficulty raising and clearing secretions secondary to: a. Cancer or surgery of the throat or mouth b. Dysfunction of the swallowing muscles c. Unconscious or obtunded state d. Tracheostomy Suction catheters and sterile water or saline are covered when medically necessary. Sterile water/saline is covered only for beneficiaries who have a tracheostomy. Tracheal suction catheters are covered only when patient has a Tracheostomy. Coverage is for a maximum of three (3) catheters per day for tracheal suction and three (3) catheters per week for non-tracheal suction. Coverage and Payment Policy for Gastrointestinal Suction Pumps: Will be approved only for those patients with a gastrointestinal tube in place; and Documentation from treating clinician of an obstructive gastrointestinal diagnosis. Accessories and supplies are included in the rental fee. When billing for supplies greater than what is allowed, supporting documentation must accompany the prior authorization. Click here for an approved PDF version of the Suction Pumps coverage guidelines. Surgical Supplies Coverage and Payment Policy Surgical supplies are covered for beneficiaries who require home treatment of a specific medical condition, protection or support of a wound, surgical incision or diseased or injured body part. Proof of Medical Necessity-A certificate of medical necessity (CMN), Prescription pad, or letter, must be on file for all supplies requested by the physician and it must indicate the duration of therapy. If the therapy is long term, updated proof of medical necessity must be on file every year. If prescribed supplies exceed the stated policy allowance, prior authorization is required. Click here for an approved PDF version of the Surgical Supplies coverage guidelines. Therapy Related Equipment Indications Therapy Related Equipment will be covered for those recipients under the EPSDT Program who are enrolled in a Physical, Occupational or Speech Therapy Program. The equipment must be an integral and necessary part of the program. Coverage and Payment Policy Prior authorization for requested equipment must include documentation from the Physical, Speech or Occupational Therapist that the child is enrolled in a therapy program and the equipment is an integral and necessary part of the program. Equipment included in this therapy will be mats, grasshoppers, bolster chairs, therapy balls, etc. Those services not included will be tricycles, bicycles, swings, or any other equipment that is not primarily medical in nature. These services are billable under Minor Assistive Devices. Transcutaneous Electrical Nerve Stimulator (TENS) And Related Supplies Indications A Transcutaneous Electrical Nerve Stimulator (TENS) is covered for the treatment of recipients with chronic, intractable pain or acute post-operative pain who meet the coverage rules listed below. Coverage and Payment Policy This service requires prior authorization. When a TENS unit is used for acute post-operative pain, the medical necessity is limited to 30 days from the day of surgery. Payment will be made only as a rental. A TENS unit will be denied as not medically necessary for acute pain (less than three months duration) other than post-operative pain. For chronic pain, the medical record must document the location of the pain, the duration of time the recipient has had the pain, and the presumed etiology of the pain. The pain must have been present for at least three months. Other appropriate treatment modalities must have been tried and failed, and the medical record must document what treatment modalities have been used (including the names and dosage of medication), the length of time that each type of treatment was used, and the results. The presumed etiology of the pain must be a type that is accepted as responding to TENS therapy. Examples of conditions for which a TENS unit are not considered to be medically necessary are (not all-inclusive): headache, visceral abdominal pain, pelvic pain, and temporomandibular joint (TMJ) pain. When used for the treatment of chronic, intractable pain, the TENS unit must be used by the recipient on a trial basis for a minimum of one month (30 days), but not to exceed two months. The trial period will be paid as a rental. The trial period must be monitored by the physician to determine the effectiveness of the TENS unit in modulating the pain. For coverage of a purchase, the physician must determine that the recipient is likely to derive significant therapeutic benefit from continuous use of the unit over a long period of time. The physician's records must document a reevaluation of the recipient at the end of the trial period, must indicate how often the recipient used the TENS unit, the typical duration of use each time, and the results. A 4 lead TENS unit may be used with either 2 leads or 4 leads, depending on the characteristics of the recipient's pain. If it is ordered for use with 4 leads, the medical record must document why 2 leads are insufficient to meet the patients needs. During the rental of a TENS unit, supplies for the unit are included in the rental allowance; there is no additional allowance for electrodes, lead wires, batteries, etc. If a TENS unit is purchased, the allowance includes lead wires and one month's supply of electrodes, conductive paste or gel (if needed), and batteries. Separate allowance will be made for replacement supplies when they are medically necessary and are used with a TENS unit that has been purchased and/or approved by the Medical Assistance Program. If 2 TENS leads are necessary, then a maximum of one unit would be allowed per month; if 4 TENS leads are necessary, a maximum of two units per month would be allowed. If the use of the TENS unit is less than daily, the frequency of billing for the TENS supply code should be reduced proportionally. Unit Replacement Components There should be no separate billing, and there will be no separate allowance, for replacement electrodes, conductive paste or gel, replacement batteries, or a battery charger. Replacement of lead wires will be covered when they are inoperative due to damage and the TENS unit is still medically necessary. Replacement more often than every 12 months would rarely be medically necessary. A TENS supply allowance includes electrodes (any type), conductive paste or gel (if needed, depending on the type of electrode), tape or other adhesive (if needed, depending on the type of electrode), adhesive remover, skin preparation materials, batteries (9 volt or AA, single use or rechargeable), and a battery charger (if rechargeable batteries are used). One unit of service represents supplies needed for one month for a 2 lead TENS, assuming daily use. Unit Supplies Other supplies, including but not limited to the following, will not be separately allowed: adapters (snap, banana, alligator, tab, button, clip), belt clips, adhesive remover, additional connecting cable for lead wires, carrying pouches, or cover. A conductive garment for use with a TENS unit is rarely medically necessary, but may be covered if all of the following conditions are met: It has received permission or approval for marketing by the Food and Drug Administration; and It has been prescribed by a physician for use in delivering covered TENS treatment; and One of the medical indications outlined below is met: The recipient cannot manage without the conductive garment because there is such a large area or so many sites to be stimulated and the stimulation would have to be delivered so frequently that it is not feasible to use conventional electrodes, adhesive tapes, and lead wires; or The recipient cannot manage without the conductive garment for the treatment of chronic intractable pain because the areas or sites to be stimulated are inaccessible with the use of conventional electrodes, adhesive tapes, and lead wires; or The recipient has a documented medical condition, such as skin problems, that preclude the application of conventional electrodes, adhesive tapes, and lead wires; or The recipient requires electrical stimulation beneath a cast either to treat disuse atrophy where the nerve supply to the muscle is intact or to treat chronic intractable pain. The physician ordering the TENS unit must be the attending physician or a consulting physician for the disease or condition resulting in the need for the TENS unit. Click here for an approved PDF version of the Transcutaneous Electrical Nerve Stimulator coverage guidelines. Ventilators Coverage and Payment Policy Volume or pressure ventilators are medically necessary for members who require breathing assistance by an external mechanical device. A volume or pressure support ventilator is used for mechanically assisted breathing using an electrically powered device that forces oxygenated or room air into the lungs and allows time for exhalation. Members requiring ventilators will generally have neuromuscular disorders, thoracic restrictive disorders or chronic respiratory failure consequent to chronic obstructive pulmonary disease. This service requires prior authorization. Ventilators are supplied on a continuous rental basis and all associated supplies are included in the rental fee. Backup Ventilator: A backup ventilator is defined as an identical or similar device used to meet the same medical needs for the member but provided at the bedside as a precaution in case of malfunction of the primary ventilator. Requests for a backup ventilator will be reviewed on a case by case basis. Second Ventilator: A second ventilator is one which serves a different purpose than the primary ventilator, as determined by the patient's medical needs. Medical documentation must indicate the specific needs the second ventilator will address. Click here for an approved PDF version of the Ventilator coverage guidelines. Walker Walkers are covered when the beneficiary has a mobility limitation that significantly impairs their ability to participate in one or more mobility related activities of daily living (MRADL) in the home. Coverage and Payment Policy A walker will be covered if all of the following criteria are met: 1. The beneficiary has a mobility limitation that significantly impairs his/her ability to participate in one or more mobility-related activities of daily living (MRADL). A mobility limitation is one that: a. Prevents the beneficiary from accomplishing the MRADL entirely; or b. Places the beneficiary at heightened risk of morbidity or mortality secondary to attempts to perform MRADL, or c. Prevents the beneficiary from completing the MRADL within a reasonable time frame; and 2. The beneficiary is able to safely use the walker; and 3. The functional mobility deficit can be sufficiently resolved with the use of a walker. Equipment/Walker Type: Standard: see criteria above. Heavy-duty: beneficiary must meet criteria above and weigh 300 pounds or more. Heavy-duty/multiple braking system; beneficiary must meet criteria above and be unable to use a standard walker due to severe neurologic disorder or other condition which restricts the use of one hand. Prior authorization is required. Walker with trunk support; beneficiary must meet criteria above and have documentation in the medical record justifying the need for this special feature. Leg extensions; beneficiary must be six (6) feel tall or more. Click here for an approved PDF version of the Walker coverage guidelines. Wheelchairs, Strollers Indications A wheelchair is covered if the recipient's condition is such that without the wheelchair they would otherwise be bed confined and safe ambulation cannot be achieved with a cane, crutches or walker. An individual may qualify for a wheelchair and still be bed confined. This basic requirement must be met for coverage of any wheelchair. Manual wheelchairs are covered for those recipients that can self propel themselves or are transferred by another individual. Motorized/Power wheelchairs are covered for those recipients who cannot self propel themselves and are capable of safely operating the controls. Options and accessories for wheelchairs are covered if medically necessary and documented by the recipient’s physician. Coverage and Payment Policy An option/accessory that is beneficial primarily in allowing the Payment Policy recipient to perform leisure or recreational activities will not be covered wheelchair. A fully reclining back option is covered if the recipient spends at least two hours per day in the wheelchair and has one or more of the following conditions/needs: Quadriplegia, Fixed hip angle, Trunk or lower extremity casts/braces that require the reclining back feature for positioning, Excess extensor tone of the trunk muscles, Recipient needs to rest in a recumbent position two or more times during the day and transfer between wheelchair and bed is very difficult. A nonstandard seat width, depth, or height is covered only if: The ordered item is at least 2 inches greater than or less than a standard option, and The recipient's dimensions justify the need. Swingaway, detachable footrests are included in the allowance for the wheelchair base. They should be billed separately only when they are replacements. Elevating legrests are covered if: The recipient has a musculoskeletal condition or the presence of a cast or brace which prevents 90 degree flexion at the knee, or The criteria for a reclining back option are met. An articulating (telescoping) elevating legrest does not have significant benefits compared to a standard (non-telescoping) elevating legrest. If the criteria for an elevating legrest are met, payment will be based on the allowance for the least costly alternative. Reinforced back upholstery or reinforced seat upholstery is included in the allowance for a heavy duty or extra heavy duty wheelchair. It would not be medically necessary if used in conjunction with other manual wheelchair bases. It would be covered if used with a power wheelchair base and the patient weighed more than 200 pounds. Hook-on headrest extension is covered if the recipient: Has weak neck muscles and needs a headrest for support, or Meets the criteria for and has a reclining back on the wheelchair. A solid seat insert is covered when the recipient spends at least two hours per day in the wheelchair. A safety belt/pelvic strap is covered if the recipient has weak upper body muscles, upper body instability or muscle spasticity which requires use of this item for proper positioning. Anti-rollback device is covered if the recipient propels himself/herself and needs the device because of ramps. Coverage and Payment Policy A recipient who requires a power wheelchair usually is totally nonambulatory and has severe weakness of the upper extremities due to a neurologic or muscular disease/condition. Options that are beneficial primarily in allowing the recipient to perform leisure or recreational activities will not be covered. Payment will be based on the allowance for the least costly alternative which is medically necessary. A power wheelchair is covered if the recipient's condition is such that the requirement for a power wheelchair will be long term (at least six months). Reimbursement for the wheelchair codes includes all labor charges involved in the assembly of the wheelchair and all covered additions or modifications. Reimbursement also includes support services, such as emergency services, delivery, set-up, education, and on-going assistance with use of the wheelchair. A customized wheelchair will be considered for payment if the physician indicates that the condition or size of the recipient prevents them from benefiting from a standard wheelchair. The physician or therapist must document this on the CMN. Prior authorization is required. Strollers will be considered for payment if the recipient is over eighteen months of age, requires transportation and meets the requirements for a wheelchair, but because of size or convenience a stroller is more beneficial. Wigs Coverage and Payment Policy This service requires prior authorization. The prescribing provider must submit the following information and one of the following must be present: Alopecia secondary to cancer related therapy; or Alopecia related to: a. Auto-immune diseases; or b. Trauma; or c. Burns Replacement wigs are covered in the event the wig is lost or unusable and the underlying medical condition is still present. Exclusions: Male or female pattern baldness Click here for an approved PDF version of the Wig coverage guidelines.