DMERC REGION C PHYSICIAN INFORMATION SHEET (PHYIS): Continuous Positive Airway Pressure (CPAP) System

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1 DMERC REGION C PHYSICIAN INFORMATION SHEET (PHYIS): Continuous Positive Airway Pressure (CPAP) System The Durable Medical Equipment Regional Carrier (DMERC) medical review policy on continuous positive airway pressure (CPAP) is based upon HCFA national policy. According to HCFA national policy, CPAP is covered for obstructive sleep apnea (OSA) only. (If a patient suffers with significant ventilatory insufficiency during the sleep state due to central sleep apnea or other respiratory compromise associated with a musculoskeletal or pulmonary condition, a ventilator, rather than CPAP, may be covered.) This is an important distinction for the Medicare program, because CPAP and BiPAP (see descriptions below) cost the Medicare program approximately $100/month or $200/month respectively, which is paid up to the purchase price within approximately one year. However, ventilators used to treat states of sleep-associated respiratory insufficiency other than obstructive sleep apnea, cost the program about $570/month, which is paid indefinitely (because of the need to frequently service these more complex devices). A CPAP (HCPCS Code E0601) device uses a generator to provide forced air at a constant pressure via a nasal mask to a sleeping patient, thus preventing the soft oropharyngeal walls from collapsing during REM sleep. If the patient finds CPAP too disruptive to their sleeping pattern, it may be appropriate to then try BiPAP (HCPCS Code E0452), which adds the additional feature of decreasing provided air pressure during the expiratory phase of the patient s respirations, allowing for less resistance to natural exhalation. The increased pressure provided during inspiration still successfully maintains the patency of the airway. A therapeutic ventilator intended for use less than 12 hours per day (HCPCS Code E0453) adds the additional feature of setting a backup ventilatory rate, which might be needed for central sleep apnea and other forms of sleep-associated respiratory failure. It may be used to provide non-invasive ventilation with a face mask rather than via a tracheostomy. This latter device, costing Medicare greater than five times as much per month and reimbursing indefinitely, is obviously not necessary for a patient with OSA only, whose spontaneous respiratory rate is unimpaired. National and therefore DMERC policies cover CPAP for OSA when a polysomnogram, recorded during a minimum of 6 7 hours of sleep, documents at least 30 episodes of apnea lasting at least 10 seconds. At this time, national policy does not cover episodes of hypopnea (decreased respiratory volume or rate), as opposed to episodes of apnea (complete absence of respirations due to oropharyngeal obstruction). The polysomnogram, along with pulmonary function tests and oxygen saturations, must be recorded in a sleep laboratory and be available to the DMERC for subsequent evaluation should they be requested. The physician is expected to complete a DMERC CMN for CPAP. Region C DMEPOS Supplier Manual (Autumn 1999) 69.1

2 The CMN is supposed to show the physician the cost of the items being ordered. The physician question section (Section B) of the CMN is not to have been completed by the supplier. It must be completed, or at least reviewed, signed and dated by the treating physician. Based upon the above discussion, the physician is cautioned not to authorize an E0453 if the patient s condition involves only OSA. This physician information sheet was originally published in the Winter 1997 DMERC Medicare Advisory. Paul D. Metzger, M.D. Medical Director, Region C DMERC Palmetto Government Benefits Administrators, LLC Columbia, SC 69.2 Region C DMEPOS Supplier Manual (Winter 1999)

3 DMERC REGION C PHYSICIAN INFORMATION SHEET (PHYIS): Enteral Nutrition Enteral nutrition is the provision of nutritional requirements through a tube into the stomach or small intestine. It is covered by Medicare for patients with diseases or structural defects of the alimentary tract that interfere with transport, digestion or absorption of nutrients to a degree that oral ingestion proves inadequate to maintain weight and strength commensurate with overall health status. Such conditions may include anatomic obstructions such as head and neck cancers, or motility disorders such as dysphagia or gastroparesis. Even neurological disorders (eg., Alzheimer's) resulting in this degree of ingestional dysfunction would qualify for coverage. The severity of these conditions which warrants coverage is reflected in the physician's decision to insert and maintain a feeding tube in the patient. Coverage is possible for patients with partial impairments - e.g., a patient with dysphagia who can swallow small amounts of food or a patient with Crohn's disease who requires prolonged infusion of enteral nutrients to overcome a problem with absorption. Questions often arise about patients whose conditions are either improving or deteriorating and may be transitioning to or from a tubefeeding situation. They may be getting some of their nutrients orally, but require tube feedings to maintain their nutritional status. So long as the physician sees fit to maintain the enteral tube, Medicare will cover those nutrients administered via that tube. In order to be covered, the physician must judge the condition to be permanent - expected to last greater than three months, or until the patient's death, whichever is shorter. Conditions which are not covered (even though they may involve tube feedings) include anorexia and nausea secondary to mood disorders and end-stage diseases not directly involving the gastrointestinal tract. Only those nutrients administered via the feeding tube are covered by Medicare. (Enteral nutrients taken orally are not covered by Medicare.) Baby food and blenderized grocery products are not covered, even if administered via a feeding tube. Medicare pays for supplies required for different methods of administering tube feedings (gravity, syringe or a pump). Medical records should reflect medical conditions requiring controlled administration of nutrients through a pump. More than one nasograstric tube per month or one gastrojejunostomy tube every 3 months are rarely medically necessary. (While disoriented patients may remove their own tubes leading to the use of more tubes, such an occurrence is not considered strictly an issue of medical necessity and is not reimbursable.) Dressings used for the insertion site of enteral tubes are reimbursed as part of the "administration kit," and are not separately payable. Most enteral nutrient products sufficient to achieve and maintain adequate nutritional status are grouped into a basic HCPCS billing code (B4150) and are reimbursed at the same rate. Products made of natural intact protein (HCPCS code B4151) are covered for patients who have demonstrated an allergy or intolerance to the basic semi-synthetic products. Special, more highly reimbursed products (HCPCS codes B4153-B4155) need to be justified for each patient. The physician must document why he or she is ordering these products (such as those that are disease-specific). Region C DMEPOS Supplier Manual (Autumn 1999) 69.3

4 DOCUMENTATION If you order enteral nutrition for your patient, it is necessary to complete a Certificate of Medical Necessity (CMN), in order for the supplier to be reimbursed by Medicare. The physician is expected to have seen the patient within 30 days prior to initially certifying the need for enteral nutrition, or document why not, and what monitoring methods were used to evaluate the patient's enteral nutrition needs. Routine recertifications are no longer required. However, changes in your orders may require completion of revised CMNs. Section B of the CMN contains questions pertaining to the medical necessity of the equipment which may not be completed by the supplier. The physician or another health care clinician may complete Section B, but only the patient's treating physician may sign the CMN, indicating that he/she has reviewed Section B of the CMN for accuracy and completeness. The patient's medical records must contain documentation substantiating that the patient's condition meets the above coverage criteria and the answers given in Section B of the CMN. These records may be requested by the DMERC to confirm corroboration by the medical record of the information submitted to the DMERC. This physician information sheet was originally published in the Winter 1998 DMERC Medicare Advisory. Paul D. Metzger, M.D. Medical Director, Region C DMERC Palmetto Government Benefits Administrators, LLC Columbia, SC 69.4 Region C DMEPOS Supplier Manual (Autumn 1999)

5 DMERC REGION C PHYSICIAN INFORMATION SHEET (PHYIS): External Infusion Pumps This PHYIS has been revised from one originally issued in December, It contains the following important changes: Added coverage of epoprostenol sodium for the treatment of primary pulmonary hypertension or pulmonary hypertension which is secondary to a connective tissue disease; Added coverage of insulin infusion pumps and insulin administered through them as of 4/1/2000 for type 1 diabetics. For the purposes of this policy, type 1 diabetes mellitus is identified by a serum C-peptide level < 0.5 mcg/l. See below for further details of coverage. Coverage The Medicare benefit under which pumps are covered comes under the category of Durable Medical Equipment (DME). Medicare does not usually cover self-administered medications. However, the Durable Medical Equipment Regional Carrier (DMERC) does cover the use of external infusion pumps when they are medically necessary, and therefore, will also cover those medications administered through these pumps in the home setting only if strictly controlled infusion of the medication is medically necessary. Though a physician may order medication to be delivered through a pump, this alone will not suffice to justify Medicare coverage of the pump and medication. The primary criterion for coverage is the necessity of the pump, defined by the medication requiring strictly controlled infusion; once the pump's medical necessity is established, the medication is covered as a "supply" of the pump. National HCFA policy has defined specific situations in which infusion pumps will be covered. The DMERC Regional Medical Review Policy (RMRP) on external infusion pumps incorporates National policy coverage criteria and further defines situations in which the medical necessity of strictly controlled infusion is established. According to National Policy criteria the following situations requiring an external infusion pump are covered: the administration of deferoxamine for the treatment of chronic iron overload; Chemotherapy for the treatment of primary hepatocellular carcinoma or colorectal cancer where this disease is unresectable or where the patient refuses surgical excision of the tumor; Morphine when used in the treatment of intractable pain caused by cancer. Continuous subcutaneous administration of insulin through an external insulin infusion pump to a type 1 diabetic with further coverage criteria discussed below. National policy explicitly excludes from coverage infusion pumps in the home setting used for: Region C DMEPOS Supplier Manual (Summer 2000) 69. 5

6 heparin for the treatment of thromboembolic disease and/or pulmonary embolism; DMERC RMRP lists additional coverage criteria based on two situations where strictly controlled infusion are considered a medical necessity: 1. (where prolonged infusion time (greater than 8 hours per infusion) affords proven increased treatment efficacy over shorter duration infusions (which can be accomplished using bolus injections, gravity drip with calibrated controllers, or non-durable, disposable infusion systems, such as elastomeric pumps), or 2. where too rapid an infusion could be systemically harmful to the patient because of drug toxicity, unless strictly controlled by use of an infusion pump (as indicated in the Physician's Desk Reference, or the U.S. Pharmacopoeia Drug Information). In all of the above situations, administration of a particular drug within the home setting must be reasonable, necessary and safe. Some examples where drugs are covered, according to the above criteria are: A. The administration of cladribine, fluorouracil, cytarabine, bleomycin, floxuridine, doxorubicin, vincristine or vinblastine by continuous infusion over at least 8 hours when the regimen is proven or generally accepted to have significant advantages over intermittent administration regimens. (Because National HCFA Policy supersedes DMERC RMRP, should chemotherapeutic regimens be used in the treatment of primary hepatocellular carcinoma or liver metastases from colorectal carcinoma, the regimen would not have to meet the test of proven increased efficacy over shorter duration protocols.) B. The administration of narcotic analgesics (except meperidine) in place of morphine to a patient with intractable pain caused by cancer who has not responded to an adequate oral/transdermal therapeutic regimen and/or cannot tolerate oral/transdermal narcotic analgesics. There are two types of morphine, that which is preservative-free, and that which contains preservatives. The preservative-free morphine is far more expensive and is only necessary for epidural infusions. C. The administration of foscarnet, amphotericin B, acyclovir and ganciclovir. Liposomal amphotericin B (J0286) is covered for patients who meet one of the following criteria: 1. The patient has suffered some significant toxicity that would preclude the use of standard amphotericin B and is unable to complete the course of therapy without the liposomal form, or 2. The patient has significantly impaired renal function. D. Administration of parenteral inotropic therapy, using the drugs dobutamine, milrinone and/or dopamine for patients with congestive heart failure and depressed cardiac function if a patient has all of the following conditions: 1. Dyspnea at rest despite treatment with maximum or near maximum tolerated doses of digoxin, a loop diuretic, and an angiotensin converting enzyme inhibitor or another vasodilator (e.g. hydralazine or isosorbide dinitrate), used simultaneously (unless allergic or intolerant), and 69.6 Region C DMEPOS Supplier Manual (Summer 2000)

7 2. Doses are within the following ranges (lower doses will be covered only if part of a weaning or tapering protocol from higher dose levels): a) Dobutamine mcg/kg/min b) Milrinone mcg/kg/min c) Dopamine < 2 mcg/kg/min, and 3. Invasive hemodynamic studies performed within 6 months prior to the initiation of home inotropic therapy show (a) cardiac index (CI) is less than or equal to 2.2 liters/min/meter squared and/or pulmonary capillary wedge pressure (PCWP) is greater than or equal to 20 mm Hg before inotrope infusion on maximum medical management and (b) at least a 20 % increase in CI and/or at least a 20 % decrease in PCWP during inotrope infusion at the dose initially prescribed for home infusion, and 4. An improvement in patient well being, (less dyspnea, improved diuresis, improved renal function and/or reduction in weight) with the absence of dyspnea at rest at the time of discharge and the capability of outpatient evaluation by the treating physician at least monthly, and 5. In the case of continuous infusion, there is documented deterioration in clinical status when the drug(s) is tapered or discontinued under observation in a hospital, or in the case of intermittent infusions, there is documentation of repeated hospitalizations for congestive heart failure despite maximum medical management, and 6. Any life threatening arrhythmia is controlled prior to hospital discharge and there is no need for routine electrocardiographic monitoring at home, and 7. The patient is maintained on the lowest practical dose and efforts to decrease the dose of the drug(s) or the frequency/duration of infusion are documented during the first 3 months of therapy, and 8. The patient's cardiac symptoms, vital signs, weight, lab values, and response to therapy are routinely assessed and documented in the patient's medical record. E. Administration of parenteral epoprostenol sodium for patients with primary pulmonary hypertension (PPH) or pulmonary hypertension which is secondary to a connective tissue disease if the patient meets all of the following criteria: 1. Pulmonary hypertension is evidenced by a mean pulmonary artery pressure of greater than 25 mm Hg at rest, or greater than 30 mm Hg with exercise, in the absence of any clinically important left-sided cardiac valvular disease, myocardial disease, congenital heart disease, respiratory disease, or chronic thromboembolic disease, and 2. The patient has significant symptoms from the pulmonary hypertension (i.e., dyspnea on exertion, and either, fatigability, angina, or syncope), and 3. A clinical trial of oral calcium channel blocking agents has been conducted or considered prior to long term commitment to chronic intravenous epoprostenol therapy. F. Administration of continuous subcutaneous insulin for the treatment of diabetes mellitus, type 1 (ICD-9 CM codes , , , , , , , , , , , , , , , , , , , Region C DMEPOS Supplier Manual (Summer 2000) 69. 7

8 250.93), which has been documented by a serum C-peptide level < 0.5 mcg/l, if either of the following criteria (1) or (2) are met: 1. The patient has completed a comprehensive diabetes education program, has been on a program of multiple daily injections of insulin (i.e. at least 3 injections per day), with frequent self-adjustments of insulin dose for at least 6 months prior to initiation of the insulin pump, and has documented frequency of glucose self-testing an average of at least 4 times per day during the 2 months prior to initiation of the insulin pump, and meets one or more of the following criteria (a e) while on the multiple injection regimen: (a) Glycosylated hemoglobin level (HbA1C) > 7% (b) History of recurring hypoglycemia (c) Wide fluctuations in blood glucose before mealtime (d) Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dl (e) History of severe glycemic excursions 2. The patient with type 1 diabetes has been on an external insulin infusion pump prior to enrollment in Medicare and has documented frequency of glucose self-testing an average of at least 4 times per day during the month prior to Medicare enrollment. For patients who have purchased an external insulin infusion pump prior to April 1, 2000, insulin and supplies used with the pump are covered during the period of covered use of the pump provided the patient is a type 1 diabetic as evidenced by a serum C-peptide level < 0.5 mcg/l. Continued coverage of an external insulin pump requires that the patient be seen and evaluated by the treating physician at least every 3 months. In addition, the external insulin infusion pump must be ordered and follow-up care rendered by a physician who manages multiple patients on continuous subcutaneous insulin infusion therapy and who works closely with a team including nurses, diabetic educators, and dieticians who are knowledgeable in the use of continuous subcutaneous insulin infusion therapy. External insulin infusion pumps for type 2 diabetics, including insulin-treated type 2 diabetics, will be denied as not medically necessary. Equipment When an infusion pump is covered, the drug necessitating the use of the pump and necessary supplies are also covered. When a pump has been purchased by the Medicare program, other insurer, or the patient, or the rental cap has been reached, the drug necessitating the use of the pump and supplies are covered as long as the coverage criteria for the pump continue to be met. Disposable drug delivery systems, including elastomeric infusion pumps, are non-covered devices because they do not meet the Medicare definition of durable medical equipment. Drugs and supplies used with disposable drug delivery systems are also non-covered items. All dressings and solutions used in the care of the infusion site, such as a peripheral or centrally inserted intravenous site, peripherally inserted central catheter (PICC), or an epidural catheter, are covered as a single kit per week during the time a pump is being used for medication infusions, as well as for the weeks between infusions, not to exceed four weeks at a time. Supplies should not be separately billed aside from the kit Region C DMEPOS Supplier Manual (Summer 2000)

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10 An administration kit includes all items associated with administration of the medication, including the cassette or bag which holds the medication, diluting solutions, tubing and other administration supplies, port cap changes, compounding charges, and preparation charges. These items should not be separately billed aside from the administration kit. The number of administration kits covered is based on the number of cassettes or bags that are medically necessary to appropriately administer the medication. CMNs For an item(s) to be considered for coverage and payment by Medicare, the information on the CMN or order submitted by the physician to the supplier must be corroborated by documentation in the patient s medical records that Medicare coverage criteria have been met. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records or records from other healthcare professionals. The Certificate of Medical Necessity (CMN) for external infusion pumps is DMERC CMN 09 (OMB Form 851). Physicians are expected to review Section A of the CMN for accuracy of patient and physician name, address, physician identification number, etc. He or she must complete or review for accuracy, answers to the questions # 1-7 in Section B, including the correct diagnoses codes, and estimated length of need. Section B should not have been completed by the supplier of the items/supplies, nor should the physician sign an incomplete CMN. The physician should also examine Section C, to ascertain that only the equipment and supplies he or she has actually ordered are accurately listed, along with the charges associated with the pump, accessories, supplies, and drugs. The physician attests to all of the above by signing and dating the CMN in Section D. Signature stamps are not to be used. For external insulin infusion pumps, an ICD-9-CM diagnosis code (specific to the 5 th digit), describing the condition which necessitates the pump, must be included on each order and CMN for the pump, insulin and/or supplies. On initial orders for external insulin infusion pumps, insulin and/or supplies, the results of the patient s C-peptide level must be included. If the infusion pump is being ordered for home infusion of dobutamine or epoprostenol extra documentation instructions are available from the supplier which will be necessary to assure proper claims adjudication for medical necessity. Paul D. Metzger, M.D. Medical Director, Region C DMERC Palmetto GBA Columbia, SC 69.8a Region C DMEPOS Supplier Manual (Summer 2000)

11 DMERC REGION C PHYSICIAN INFORMATION SHEET (PHYIS): Hospital Beds DESCRIPTION OF EQUIPMENT: An ordinary bed (not a hospital bed) is one which is typically sold as furniture. It consists of a frame, box spring and mattress. The frame is a fixed height from the floor and has no head or leg elevation adjustments. An ordinary bed will accommodate most transfers to a chair, wheelchair or standing position. If needed, it can almost always be adjusted to accommodate these transfers. The need for a particular height from the floor would rarely by itself justify the need for a hospital bed. Hospital beds allow the patient's position to be changed at the head and foot of the bed, as well as the distance of the bed frame from the floor. Hospital beds may be: Totally Manual and of Fixed Height, having manual (a cranking mechanism) head and leg elevation adjustments, but no height adjustment; Totally Manual and with Variable Height, having additionally, manual height adjustment; Semi-Electric, having electric head and leg adjustment, but still manual height adjustment; Total Electric, having electric head and leg adjustment, plus electric height adjustment. INDICATIONS FOR HOSPITAL BEDS: Fixed Height (One or more of the following): A patient who requires positioning of the body in ways not feasible with an ordinary bed, for the alleviation of pain. A patient who requires the head of the bed to be elevated more than 30 degrees most of the time due to congestive heart failure, chronic pulmonary disease, or problems with aspiration. Pillows or wedges should first have been considered.a patient who requires traction equipment which can only be attached to a hospital bed. A patient who requires traction equipment which can only be attached to a hospital bed. Variable Height (In addition to one of the above): The patient requires a bed height different than a fixed height hospital bed to permit transfers to chair, wheelchair or standing position. Region C DMEPOS Supplier Manual (Autumn 1999) 69.9

12 Semi-Electric: In addition to the above indications, the patient requires frequent or immediate changes in body position. Total Electric: (Not covered by Medicare): The additional feature allowing for motorized adjustment of the height of the bed frame from the floor is strictly for the convenience of the caregiver. While the caregiver may have true limitations in his/her ability to minister to the patient, the laws upon which Medicare national payment policy is based do not allow for consideration to be extended to the patient's caregiver. Therefore, this added feature is not covered. However, this does not mean that the more basic (semi-electric) feature of the bed will be denied. If the indications for a semi-electric bed are met, then payment will be made by Medicare at the level of a semi-electric bed. COMMENT: It is rarely necessary for a patient to require changes from one type of hospital bed to another (e.g., variable height to semi-electric) once, in the judgment of the physician, a particular level of bed has been ordered. It is inconceivable that a patient should progress from a higher to a lower level bed (e.g., semi-electric to a variable height). Medicare should not pay for two beds, when the needs of the patient could have been anticipated based on the clinical condition originally judged to require a hospital bed. DOCUMENTATION: The supplier of your patient's equipment must submit a Certificate of Medical Necessity (CMN) with the claim in order to obtain Medicare reimbursement. Section B of the CMN contains questions pertaining to the medical necessity of the equipment which may not be completed by the supplier. The physician or another health care clinician involved in the care of the patient may complete Section B, BUT ONLY THE PATIENT'S PHYSICIAN MAY SIGN THE CMN, INDICATING THAT HE/SHE HAS REVIEWED SECTION B OF THE CMN FOR ACCURACY AND COMPLETENESS. In addition, the physician should review Section A to affirm that this is the appropriate patient, and Section C to ascertain that this is the equipment that has been ordered, and that the supplier s charges and expected Medicare reimbursement have been entered onto the form for the physician s review. The physician's medical record of the patient must contain documentation substantiating that the patient's condition meets the above coverage criteria and the answers given in Section B of the CMN. These records may be requested by the DMERC to confirm concurrence between the medical record and the information submitted to the DMERC. This physician information sheet was originally published in the Summer 1999 DMERC Medicare Advisory. Paul D. Metzger, M.D. Medical Director, Region C DMERC Palmetto Government Benefits Administrators, LLC. Columbia, SC Region C DMEPOS Supplier Manual (Autumn 1999)

13 DMERC REGION C PHYSICIAN INFORMATION SHEET (PHYIS): Lymphedema Pumps These are also known as pneumatic compression devices. They should be used as a treatment of last resort for truly refractory lymphedema, associated with congenital and acquired conditions resulting in lymphatic blockage. Examples of such conditions would be Milroy s Disease, Lymphedema praecox and tarda, malignancies that involve axillary or pelvic lymph nodes, or surgery and/or radiation that have the same resultant effect. Lymphedema pump devices are only covered as a treatment of last resort, i.e. other less intensive treatments must have been tried first and found inadequate. Such conservative treatments that should first be tried include: limb elevation, properly applied compression dressings (as with elastic bandage wrapping), and the use of custom-fabricated gradient-pressure compression dressings. Such products are individually fitted items, that require special order and fitting according to each patient s affected limb measurements. Each of the above measures requires significant compliance by the patient and close management and follow-up by the physician. They must have been tried for a minimum of 6 months before the patient would qualify for Medicare coverage of a lymphedema pump. The lack of adequate documentation that each of the above measures had been tried would result in denial of coverage. National Medicare policy also allows for coverage of Lymphedema pumps in the treatment of chronic venous insufficiency (CVI) which has resulted in venous stasis ulcers on the affected limb(s). These ulcers must have persisted despite a minimum of 6 months of a treatment regimen including each of the above conservative components listed, in addition to the usual drug regimens used to address the underlying conditions which result in CVI. The same degree of patient compliance and close physician oversight is expected during such conservative treatment measures. Pneumatic compression devices may be covered by Medicare only when prescribed by a physician and when they are used with appropriate physician oversight, i.e. physician evaluation of the patient s condition to determine medical necessity of the device, suitable instruction in the operation of the machine, a treatment plan defining the pressure to be used and the frequency and duration of use, and ongoing monitoring of use and response to treatment. Types of lymphedema pumps The DMERC RMRP classifies lymphedema pumps into three basic categories. Those represented by the Health Care Financing Administration s (HCFA) Common Procedure Coding System (HCPCS) code E0650, have compressors which have only a single outflow port, producing one pressure, that is then transmitted by connected tubing to a sleeve ( appliance ) which wraps around the affected limb, and thereby exerts this single pressure over the entire limb, effecting lymphatic or third space fluid drainage back into the central circulation. There are available some sleeves which attach to this single port, but which Region C DMEPOS Supplier Manual (Autumn 1999) 69.11

14 supply a preset differential of pressure to distally segmented compartments. Such systems are still considered as single-ported, non-segmented E0650 pumps. Models of pumps designated by HCPCS code E0651 are truly segmented pumps, which have multiple ports on the pump delivering either different levels of pressure from each, or the same level of pressure, but at sequentially different times. Each port is connected to a separate segment of limb sleeve by its own tube. Therefore, either by sequentially timed inflation (from most distal to most proximal segment), or by differential pressures (highest most distally to lowest most proximally), a milking of fluid toward the central circulation is theoretically effected. E0651 pumps have preset pressures which do not allow for individual calibration of pressure at each port. Thus, once the most distal pressure is determined, all the other more proximal segments are predetermined by that setting. An E0652 device also has a segmented, multi-ported pump which allows for individual pressure calibration at each port. The purpose for such a device would be to decrease the pressure over a discrete area of the limb (such as a painful lesion) and yet still maintain a distal-to-proximal decreasing pressure gradient along the entire limb. An E0652 must allow for manual calibration of pressure at individual ports on a minimum of three of the pump s outflow ports. Again, merely fitting an E0650 pump with tubing or sleeves that divide the generated single pressure into some gradient of pressure at the limb does not convert the device into an E0652. The following devices are reimbursed by Medicare in these approximate amounts: HCPCS Code E0650 $ E0651 $ Approximate Amount E0652 $4, $6, When a pneumatic compression device is covered, a non-segmented device (E0650) or segmented device without manual control of the pressure in each chamber (E0651) is generally sufficient to meet the clinical needs of the patient. When a segmented device with manual control of the pressure in each chamber (E0652) is ordered and provided, payment will be based on the allowance for the least costly medically appropriate alternative, E0651, unless there is clear documentation of medical necessity in the individual case. Full payment for HCPCS code E0652 will be made only when there is a painful focal lesion (e.g. significant sensitive skin scar or contracture) of the extremity which requires a reduction in pressure over the affected segment that can only be provided by an E0652 device. There must be documentation that an E0651 device or its equivalent had been tried and had caused significant symptoms that were improved with this use of an E0652 device. As you are aware, any compression treatment for edema resulting from CVI or lymphedema unavoidably causes some degree of pain. Therefore, careful consideration should be given to the significance of pain being produced by any lesion thought to require an E0652. Documentation As with all items for which the DMERC must determine whether Medicare may reimburse, our primary contact with the physician ordering these items is the documentation sent in with the claims for the items, or which is supposed to be available in the supplier s files or the patient s medical record for subsequent review by the DMERC Region C DMEPOS Supplier Manual (Autumn 1999)

15 The physician is expected to complete a DMERC CMN for lymphedema pumps. The CMN is supposed to show the physician the cost of the items being ordered. The physician question section (Section B) of the CMN is not to have been completed by the supplier. It must be completed, or at least reviewed, signed and dated by the treating physician. In addition to completing the few questions listed on the CMN, it is necessary to further document the etiology of the condition leading to lymphedema or CVI with venous stasis ulcers. There should be documentation of the conservative measures used to treat the condition prior to ordering the lymphedema pump. If being ordered for CVI, the number, location, size and history of the venous ulcers must be indicated. If an E0652 pump is being ordered, the following additional physician information must be submitted on a signed and dated statement, submitted with the claim: 1. whether the patient has been treated with custom fabricated gradient pressure stockings/sleeves, approximately when, and the results; 2. the treatment plan, including the pressure in each chamber, and the frequency and duration of each treatment episode; 3. the location, size and etiology of the painful focal lesion which necessitates the use of this pump; 4. whether a segmented compressor without calibrated gradient pressure (E0651) or a non-segmented compressor (E0650) with a segmented sleeve had been tried and the results; 5. why the features of the system that was provided are needed for this patient; and 6. the name, model number, and manufacturer of the device. Completing all of the above information will assist the DMERC Medical Review Unit in properly determining whether a claim for this costly equipment is medically necessary, according to Medicare coverage criteria. Since these devices may currently be sold outright (not necessarily rented), ordering a lymphedema pump is not an insignificant decision. This physician information sheet was originally published in the September 1996 DMERC Medicare Advisory. Paul D. Metzger, M.D. Medical Director, Region C DMERC Palmetto Government Benefits Administrators, LLC Columbia, SC Region C DMEPOS Supplier Manual (Winter 1999) 69.13

16 69.14 Region C DMEPOS Supplier Manual (Winter 1999)

17 DMERC REGION C PHYSICIAN INFORMATION SHEET (PHYIS): MANUAL AND MOTORIZED WHEELCHAIRS AND ACCESSORIES Manual Wheelchairs A wheelchair is covered if the patient s condition is such that without the use of it, the patient would otherwise be bed or chair confined. There are different grades of wheelchairs based upon their lightness or upon their capacity to accommodate obese patients. These are classified according to HCPCS codes. If a higher grade wheelchair (lighter or heavier capacity) is prescribed primarily to allow a patient to perform leisure or recreational activities, it will be reimbursed at the level of the least costly medically necessary level, or possibly denied totally. Following are the categories of manual wheelchairs with some of their more significant features, indications and costs to the Medicare Program: K0001 K0002 K0003 K0004 K0005 K0006 K0007 K0008 Standard Wheelchair: chair weighs greater than 36 lbs. Approximate Medicare Reimbursement = $492 Standard Hemi-wheelchair: chair weighs greater than 36 lbs, but the seat is lower to the floor in order to accommodate shorter stature or for a patient who self-propels with their feet on the floor. Approximate Medicare Reimbursement = $664 Lightweight Wheelchair: chair weighs less than 36 lbs. It is covered for a patient who cannot self-propel in a standard weight wheelchair, but can self-propel in this weight chair. Approximate Medicare Reimbursement = $816 High strength, lightweight wheelchair: chair weighs less than 34 lbs., and there is a lifetime warranty on the side frames and cross braces. Covered for a patient who self-propels while engaging in frequent activities (not recreational or leisure) that cannot be performed in a standard or lightweight chair. It is also covered if the patient requires seat dimensions that cannot be accommodated in a standard, hemi, or lightweight chair, and the patient spends at least 2 hours per day in the wheelchair. It would not be covered if the patient would need it for less than 3 months (e.g., post-operative recovery). Approximate Medicare Reimbursement = $1,213 Ultra lightweight wheelchair: chair weighs less than 30 lbs., and there is a lifetime warranty on the side frames and cross braces. The need for these is rare and require individual consideration of additional documentation submitted with the Medicare claim. Approximate Medicare Reimbursement = $1,763 Heavy duty wheelchair: chair can accommodate and support a patient weighing greater than 250 lbs., or who has severe spasticity. Approximate Medicare Reimbursement = $1,148 Extra heavy duty wheelchair: chair can accommodate and support a patient weighing greater than 300 lbs. Approximate Medicare Reimbursement = $1,682 Custom manual wheelchair base: chair base is uniquely constructed for the individual patient and is like no other. It is not customized merely by the assemblage of modular components, nor Region C DMEPOS Supplier Manual (Autumn 1999) 69.15

18 K0009 the addition of various accessories to a base which could otherwise be classified into one of the other above codes. It would only be covered if it offered features not otherwise available on already manufactured chair bases. Approximate Medicare Reimbursement = Individually priced Other manual wheelchair base: because of modular construction to accommodate unusual patient measurements or requirements, the base cannot be adequately classified using one of the above codes. Approximate Medicare Reimbursement = Individually priced Motorized Wheelchairs There are various classifications of motorized wheelchairs paralleling the division existing among manual wheelchairs, based upon weight of the chair, customization or modular construction. The standard and lightweight motorized wheelchairs are reimbursed by Medicare at approximately $3,600 and $3,000 respectively. The customized and modularly constructed chairs are individually priced. One particular model, coded K0011 represents models that have additional programmable controls that allow for speed adjustment, limits on acceleration and braking, and control dampeners for patients with tremors or poor coordination. These models reimburse at approximately $5,000. There has been a significant increase in the ordering of K0011 models. Interestingly, many of the K0011s being sold look very similar to power operated vehicles (or scooters), coded E1230, which normally reimburse at approximately $2,000. While these models do furnish the control features allowing them to be properly coded as K0011, it is important for physicians to ascertain that these motorized wheelchairs are being prescribed for the indications listed below, and not being used by patients who would otherwise be sufficiently served by the ordering of scooters (see PHYIS on Power Operated Vehicles). A power wheelchair is covered when all of the following criteria are met: 1. The patient s condition is such that without the use of a wheelchair the patient would otherwise be bed or chair confined, and 2. The patient s condition is such that a wheelchair is medically necessary and the patient is unable to operate a wheelchair manually, and 3. The patient is capable of safely operating the controls for the power wheelchair. Usually, a patient who requires a power wheelchair is totally nonambulatory and has severe weakness of the upper extremities due to a neurologic or muscular condition. Similar to a power wheelchair (K0011), a power operated vehicle (or scooter) (E1230) is not covered by Medicare if the patient does not require it for mobility within the home. However, the physician should try to determine if a power operated vehicle (E1230) will serve the needs of the patient (who might have the upper trunk stability and neurologic or muscular ability to operate a scooter), as opposed to a power wheelchair (K0011). The K0011 reimburses $5,000; the E1230 reimburses $2,000. Physicians should remember that reimbursements made for durable medical equipment are drawn from the same Part B Medicare pool of funds available for payment of physician services. No claims for durable medical equipment may be reimbursed without there being an order or certificate of medical necessity completed by a physician Region C DMEPOS Supplier Manual (Autumn 1999)

19 Wheelchair Options and Accessories There are some underlying principles which apply to all options and accessories for wheelchairs: 1. In order to cover accessories, the patient must have a wheelchair base which meets Medicare coverage criteria, 2. The accessory must be necessary for the patient to function in the home environment, and 3. The accessory must be necessary to enable the patient to perform an activity of daily living. There are three accessories which have related questions on the wheelchair certificate of medical necessity, and for which there are indications specified in our published policy: Fully reclining back: to justify this feature, the patient should have one or more of the following conditions: quadriplegia, fixed hip angle, trunk or lower extremity casting or bracing requiring reclining back for positioning, excessive extensor tone of trunk muscles, or the need to rest in a recumbent position 2 or more hours during the day with transfer between wheelchair and bed being very difficult. Adjustable arm height: patient requires an arm height that is different than that available using nonadjustable arms and the patient spends a least 2 hours per day in the wheelchair. Elevating leg rests: patient has a musculoskeletal condition or has a cast or brace which prevents 90 degree flexion at the knee, or has significant edema of the lower extremities that requires leg elevation, or meets the criteria for and has a reclining back on the wheelchair. There are many other options and accessories that may be added to wheelchairs to accommodate the individual needs of patients. These are also listed in the DMERC medical policy, a copy of which you may obtain from a supplier of wheelchairs or directly from the Region C DMERC by contacting: Professional Relations, PGBA DMERC Region C, P.O. Box , Columbia, SC, Certificate of Medical Necessity The supplier of your patient s equipment must submit a Certificate of Medical Necessity (CMN) (DMERC 02) with the claim in order to obtain Medicare reimbursement. Section B of the CMN contains questions pertaining to the medical necessity of the equipment which may not be completed by the supplier. The physician or another health care clinician may complete Section B, but only the patient s treating physician may sign the CMN, indicating that he/she has reviewed Section B of the CMN for accuracy and completeness. Region C DMEPOS Supplier Manual (Autumn 1999) 69.17

20 The patient s medical records must contain documentation substantiating that the patient s condition meets the above coverage criteria and the answers given in Section B of the CMN. These records may be requested by the DMERC to confirm concurrence between the medical record and the information submitted to the DMERC. This physician information sheet was originally published in the Spring/Summer 1998 DMERC Medicare Advisory. Paul D. Metzger, M.D. Medical Director, Region C DMERC Palmetto Government Benefits Administrators, LLC Columbia, SC Region C DMEPOS Supplier Manual (Autumn 1999)

21 DMERC REGION C PHYSICIAN INFORMATION SHEET (PHYIS): Osteogenesis Stimulators Revised 6/2001 Osteogenesis stimulators (OSs) are devices used to augment bone repair associated with either a healing fracture or bone fusion. OSs may be either electrical or ultrasonic. Electrical OSs may be applied to the spine (spinal electrical OS), or other long bones (non-spinal electrical OS). They may be invasive or non-invasive. The non-invasive type (not implanted) has electrodes placed on the skin or on a cast over the fracture or fusion site. Only claims for the non-invasive types are submitted to the Durable Medical Equipment Regional Carrier (DMERC) for processing. An ultrasonic (U/S) OS is a noninvasive device that emits low intensity pulsed ultrasound. An U/S signal is applied to the skin at the fracture site via U/S coupling gel to stimulate bone healing. Non-spinal Non-invasive Electrical OS (HCPCS CODE E0747): The DMERC medical policy on OSs defines a long bone to be a clavicle, humerus, radius, ulna, femur, tibia, fibula, metacarpal, or metatarsal. Non-spinal non-invasive electrical OSs are reimbursed by Medicare DMERC for the following conditions: Nonunion of a long bone fracture defined as radiographic evidence that there has been no clinically significant evidence of fracture healing for three or more months prior to starting treatment with the osteogenesis stimulator; or Failed fusion of a joint other than in the spine where a minimum of nine months has elapsed since the last surgery; or In the treatment of congenital pseudoarthroses (no minimal time requirement with this diagnosis). Spinal Non-Invasive Electrical OS (HCPCS CODE E0748): Spinal non-invasive electrical OSs are reimbursed by Medicare DMERC for the following conditions: Failed spinal fusion where a minimum of nine months has elapsed since that fusion surgery; or Following spinal fusion surgery where there is a history of a previously failed spinal fusion at the same site (that is, a minimum of nine months have passed since attempted fusion surgery at the same level which is being fused again). Here, so long as nine months passed since the failed fusion surgery, this Region C DMEPOS Supplier Manual (Summer 2001) 69.19

22 repeated fusion attempt at the same site requires no minimum passage of time for the application of the device; or Following a multilevel spinal fusion (that is, involving three or more contiguous vertebrae, such as L3-L5 or L4-S1). Here there is no minimum time requirement for application after surgery. Ultrasonic Osteogenesis Stimulator (HCPCS Code E0760): For dates of service on or after January 1, 2001, ultrasonic (U/S) OSs are covered by Medicare. There must have been no clinically significant evidence of fracture healing for three or more months, and at least one failed open surgical intervention. U/S OSs will be covered for all bones other than the skull or vertebrae, and the fracture must not be tumorrelated. Documentation of Medical Necessity: Patient s Medical Records: For an item(s) to be considered for coverage and payment by Medicare, the information submitted by the supplier must be corroborated by documentation in the patient s medical records that Medicare coverage criteria have been met. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records or records from other healthcare professionals. This documentation must be available to the DMERC upon request. Nonunion of a fracture must be documented by a minimum of two sets of radiographs obtained prior to starting treatment with the osteogenesis stimulator, separated by a minimum of 90 days, each including multiple views of the fracture site, and with a written interpretation by a physician stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs. Certificate of Medical Necessity for Electrical OSs: Physicians who order an Electrical OS must complete or review answers to the questions concerning their patient's condition in Section B of the DMERC CMN for Osteogenesis Stimulators (DMERC 04). The questions are divided between non-spinal and spinal OSs. Although the supplier must not furnish the answers to these questions for the physician, the supplier will be expected to send an accompanying statement for the completion of question 6(a), which asks whether the patient has a nonunion of a long bone fracture. The statement will explain that in order to answer this question with a yes, there must be two sets of x- rays with an interpretation written in the patient s medical record, stating that no evidence of clinically significant healing is present between the two x-ray sets. In Section C of the CMN, the supplier should furnish a narrative description, what is being charged to Medicare, and how much Medicare should allow, which the physician may review before he or she signs the CMN Region C DMEPOS Supplier Manual (Summer 2001)