InterQual Care Planning Durable Medical Equipment Criteria 2011 Clinical Revisions

Transcription

1 InterQual Care Planning Durable Medical Equipment Criteria 2011 Clinical Revisions The Clinical Revisions provide details of changes to InterQual Clinical Criteria. They do not provide information on changes made to CareEnhance Review Manager software. For information on Review Manager software changes, see the Review Manager Release Notes and the What's New topic in CareEnhance Review Manager Help. Review and Incorporation of Recent Medical Literature McKesson Health Solutions is committed to keeping the InterQual product suite current and accurate. Criteria are continually reviewed and updated, with new editions of every product released annually. McKesson Health Solutions staff of physicians, nurses, and other licensed healthcare professionals, and its extensive array of primary care and specialty consultants, participate in ongoing criteria revision as new medical information emerges. Each annual release of the criteria reflects a thorough review of new medical literature, society guidelines, and current practice standards and incorporates consultant and user feedback. MHS Customer Hub The MHS Customer Hub ( provides interactive support, answers to commonly asked questions, and links to other resources. For a user ID and password, contact your MHS Customer Hub site administrator or MHScustomerhub@mckesson.com Enhancements Bibliography Clients may access Bibliographies from the following locations: MHS Customer Hub. Visit at Help Menu. The bibliography can be found listed in the Help Menu of all InterQual software solutions i.e., Review Manager, InterQual Online, InterQual Online Anonymous Review, and InterQual View. Click Help Menu and then click InterQual Clinical Reference to access documents. Page 1 of 20

2 New Evidence Classification Designations Comparative Effectiveness Research (CER) is used when an article describes a comparative effectiveness research study. CER studies compare two or more interventions against one another in a real-world setting (as opposed to comparing a single intervention to a placebo, sham procedure, or waiting list) and provide information on the relative strengths and weakness of each. Comparative studies are particularly useful when placebo or waitlist-controlled trials have demonstrated the efficacy of more than one intervention for a particular situation, and can help answer the question, Which of these interventions is better? Not Classified (NC) is used for sources that do not constitute clinical evidence and thus do not fit into the McKesson current evidence classification ratings of I-V. Examples of such references include laws, regulations, and online tools. Global / General Criteria Changes Revision Changed the terminology "Congestive Heart Failure (CHF)" to "Heart Failure (HF)" Rationale This change was made to reflect current medical terminology. New York Heart Association (NYHA) references retain CHF to reflect original reference. Criteria-Specific Changes Subset Indication Revision Rationale Cranial Remodeling Orthosis Deformational/positio nal plagiocephaly Removed the findings of "PE/imaging negative for craniosynostosis" and "Imaging negative for hydrocephalus" and added Deformational/positional plagiocephaly by Hx & PE/imaging Hydrocephalus and craniosynostosis would have been considered, if appropriate, and ruled out prior to making the diagnosis of deformational or positional plagiocephaly. Once the diagnosis of deformational or positional plagiocephaly has been made, the use of a cranial remodeling orthosis is appropriate if all other criteria are met. Fixed height bed (E0250, E0251, E0290, E0291, E0328) Added "and not feasible with ordinary bed" to the criteria point "Adjustable bed positions required to alleviate " A hospital bed is only necessary if the patient s needs cannot be met with an ordinary bed. Fixed height bed (E0250, E0251, E0290, E0291, E0328) Changed "Medical condition with expected duration 1 mo and positioning needs not met with an ordinary bed" to Medical condition for which positioning needs not met with an ordinary bed The expected duration of a medical condition is irrelevant if an ordinary bed does not meet the needs of the patient. Fixed height bed (E0250, E0251, E0290, E0291, E0328) Revised functional limitations criteria for the trapeze bar to clarify the clinical situations in which the equipment is medically necessary The use of the equipment should improve a patient's independence. Fixed height bed (E0250, E0251, E0290, E0291, E0328) Added criteria to identify the appropriate trapeze bar based on the patient s weight The safe use of equipment is weight-dependent. Page 2 of 20

3 Fixed height bed (E0250, E0251, E0290, E0291, E0328) Variable height bed (E0255, E0256, E0292, E0293) Variable height bed (E0255, E0256, E0292, E0293) Variable height bed (E0255, E0256, E0292, E0293) Variable height bed (E0255, E0256, E0292, E0293) Variable height bed (E0255, E0256, E0292, E0293) Semi electric bed (E0260, E0261, E0294, E0295, E0329) Semi electric bed (E0260, E0261, E0294, E0295, E0329) Added side rails as an accessory for a fixed-height bed for patients with decreased bed mobility Added "and not feasible with ordinary bed" to the criteria point "Adjustable bed positions required to alleviate " Changed "Medical condition with expected duration 1 mo and positioning needs not met with an ordinary bed" to Medical condition for which positioning needs not met with an ordinary bed Revised functional limitations criteria for the trapeze bar to clarify the clinical situations in which the equipment is medically necessary Added criteria to identify the appropriate trapeze bar based on the patient s weight. Added side rails as an accessory for a variable-height bed for patients with decreased bed mobility Added "and not feasible with ordinary bed" to the criteria point "Adjustable bed positions required to alleviate " Changed "Medical condition with expected duration 1 mo and positioning needs not met with an ordinary bed" to Medical condition for which positioning needs not met with an ordinary bed Side rails may be appropriate for a patient with decreased bed mobility to assist with positioning and rolling. A hospital bed is only necessary if the patient s needs cannot be met with an ordinary bed. The expected duration of a medical condition is irrelevant if an ordinary bed does not meet the needs of the patient. The use of the equipment should improve a patient's independence. The safe use of equipment is weight-dependent. Side rails may be appropriate for a patient with decreased bed mobility to assist with positioning and rolling. A hospital bed is only necessary if the patient needs cannot be met with an ordinary bed. The expected duration of a medical condition is irrelevant if an ordinary bed does not meet the needs of the patient. Semi electric bed (E0260, E0261, E0294, E0295, E0329) Revised functional limitations criteria for the trapeze bar to clarify the clinical situations in which the equipment is medically necessary The use of the equipment should improve a patient's independence. Semi electric bed (E0260, E0261, E0294, E0295, E0329) Added criteria to identify the appropriate trapeze bar based on the patient s weight The safe use of equipment is weight-dependent. Electric bed (E0265, E0266, E0296, E0297) Added "Patient unable to perform manual height adjustment with semi-electric bed" If a patient or caregiver can adjust the bed height on a semielectric bed, then there is no need for an electric bed. Page 3 of 20

4 Electric bed (E0265, E0266, E0296, E0297) Electric bed (E0265, E0266, E0296, E0297) Revised functional limitations criteria for the trapeze bar to clarify the clinical situations in which the equipment is medically necessary. Added criteria to identify the appropriate trapeze bar based on the patient s weight The use of the equipment should improve a patient's independence. The safe use of equipment is weight-dependent. Heavy duty extra wide (E0301, E0303)/extra heavy duty extra wide (E0302, E0304) bed Heavy duty extra wide (E0301, E0303)/extra heavy duty extra wide (E0302, E0304) bed Added "and not feasible with ordinary bed" to the criteria point "Adjustable bed positions required to alleviate " A hospital bed is only necessary if the patient needs cannot be met with an ordinary bed. Changed "Medical condition with expected duration 1 mo and positioning needs not met with an ordinary bed" to Medical condition for which positioning needs not met with an ordinary bed The expected duration of a medical condition is irrelevant if an ordinary bed does not meet the needs of the patient. Heavy duty extra wide (E0301, E0303)/extra heavy duty extra wide (E0302, E0304) bed Fixed height bed (E0250, E0251, E0290, E0291, E0328) Revised functional limitations criteria for the trapeze bar to clarify the clinical situations in which the equipment is medically necessary The use of the equipment should improve a patient's independence. Added "and not feasible with ordinary bed" to the criteria point "Adjustable bed positions required to alleviate " A hospital bed is only necessary if the patient s needs cannot be met with an ordinary bed. Fixed height bed (E0250, E0251, E0290, E0291, E0328) Changed "Medical condition with expected duration 1 mo and positioning needs not met with an ordinary bed" to Medical condition for which positioning needs not met with an ordinary bed The expected duration of a medical condition is irrelevant if an ordinary bed does not meet the needs of the patient. Fixed height bed (E0250, E0251, E0290, E0291, E0328) Revised functional limitations criteria for the trapeze bar to clarify the clinical situations in which the equipment is medically necessary The use of the equipment should improve a patient's independence. Fixed height bed (E0250, E0251, E0290, E0291, E0328) Added side rails as an accessory for fixed-height bed for patients with decreased bed mobility Side rails may be appropriate for a patient with decreased bed mobility to assist with positioning and rolling. Variable height bed (E0255, E0256, E0292, E0293) Added "and not feasible with ordinary bed" to the criteria point "Adjustable bed positions required to alleviate " A hospital bed is only necessary if the patient s needs cannot be met with an ordinary bed. Page 4 of 20

5 Insulin Pump, Ambulatory Variable height bed (E0255, E0256, E0292, E0293) Variable height bed (E0255, E0256, E0292, E0293) Variable height bed (E0255, E0256, E0292, E0293) Semi electric bed (E0260, E0261, E0294, E0295, E0329) Semi electric bed (E0260, E0261, E0294, E0295, E0329) Semi electric bed (E0260, E0261, E0294, E0295, E0329) Heavy duty extra wide (E0301, E0303)/extra heavy duty extra wide (E0302, E0304) bed Heavy duty extra wide (E0301, E0303)/extra heavy duty extra wide (E0302, E0304) bed Heavy duty extra wide (E0301, E0303)/extra heavy duty extra wide (E0302, E0304) bed Changed "Medical condition with expected duration 1 mo and positioning needs not met with an ordinary bed" to Medical condition for which positioning needs not met with an ordinary bed Revised functional limitations criteria for the trapeze bar to clarify the clinical situations in which the equipment is medically necessary Added side rails as an accessory for variable-height bed for patients with decreased bed mobility Added "and not feasible with ordinary bed" to the criteria point "Adjustable bed positions required to alleviate " Changed "Medical condition with expected duration 1 mo and positioning needs not met with an ordinary bed" to Medical condition for which positioning needs not met with an ordinary bed Revised functional limitations criteria for the trapeze bar to clarify the clinical situations in which the equipment is medically necessary Added "and not feasible with ordinary bed" to the criteria point "Adjustable bed positions required to alleviate " Changed "Medical condition with expected duration 1 mo and positioning needs not met with an ordinary bed" to Medical condition for which positioning needs not met with an ordinary bed Revised functional limitations criteria for the trapeze bar to clarify the clinical situations in which the equipment is medically necessary Removed "Diabetes management" and the populationspecific criteria for "Male/nonpregnant female age 17", "Male/nonpregnant female age 17" and "Pregnant and insulin injections 3x/day fail to meet target goals" The expected duration of a medical condition is irrelevant if an ordinary bed does not meet the needs of the patient. The use of the equipment should improve a patient's independence. Side rails may be appropriate for a patient with decreased bed mobility to assist with positioning and rolling. A hospital bed is only necessary if the patient s needs cannot be met with an ordinary bed. The expected duration of a medical condition is irrelevant if an ordinary bed does not meet the needs of the patient. The use of the equipment should improve a patient's independence. A hospital bed is only necessary if the patient s needs cannot be met with an ordinary bed. The expected duration of a medical condition is irrelevant if an ordinary bed does not meet the needs of the patient. The use of the equipment should improve a patient's independence. Criteria for number of daily insulin dosages and the need for hospitalizations for diabetic ketoacidosis are not needed to determine the appropriateness of an insulin pump if all other criteria are met. Page 5 of 20

6 Insulin Pump, Ambulatory Changed "Plasma blood glucose" to "Blood glucose" Changed "Blood sugar" to "Blood glucose" Changed "BS" to "Blood glucose" The terminology "Blood glucose" includes values obtained from a glucometer and a laboratory (plasma). Insulin Pump, Ambulatory Insulin pump (E0784) Added "Blood glucose testing 4x/day for 8 wks" as a requirement for an insulin pump Based on medical literature review, the evidence supports blood sugar testing at least four times a day for all insulin-dependent patients. Insulin Pump, Ambulatory Changed "Plasma blood glucose" to "Blood glucose" Changed "Blood sugar" to "Blood glucose" Changed "BS" to "Blood glucose" The terminology "Blood glucose" includes values obtained from a glucometer and a laboratory (plasma). Insulin Pump, Ambulatory Insulin pump (E0784) Changed "Morning fasting blood glucose > 200 mg/dl" to "Dawn phenomenon with fasting blood sugar > 200 mg/dl" Reflects current CMS medical terminology. Lower Extremity Orthotic, Knee Braces Restructured subset This subset has been restructured to utilize the etiology and symptomatology of the patient's condition to identify what type of knee brace is most appropriate. Diagnoses associated with each indication are now included within the criteria. Lower Extremity Orthotic, Knee Braces Restructured subset This subset has been restructured to utilize the etiology and symptomatology of the patient's condition to identify what type of knee brace is most appropriate and to closely align with CMS guidelines. Diagnoses associated with each indication are now included within the criteria. Lymphedema Compression Nonsegmented (E0650)/Segmented (E0651) compressor Changed "Chronic venous insufficiency with lower extremity ulceration" to "Chronic venous insufficiency with non healing lower extremity ulceration and continuous treatment 6 mos" and added the required continuous treatment, which includes "Appropriate wound care for ulcer," "Trial of compression bandaging /stockings," "Exercise program/documented contraindication to exercise," and "Extremity elevation" This change clarifies the appropriate conservative treatment for chronic venous insufficiency with non healing lower extremity ulceration prior to the application of a nonsegmented or segmented compressor. Lymphedema Compression Nonsegmented (E0650)/Segmented (E0651) compressor Added "Traumatic injury" under the clinical presentation for "Stage II/Stage III refractory lymphedema" A severe traumatic injury in which the lymphatic system is interrupted and/or damaged in any way may trigger the onset of lymphedema. Page 6 of 20

7 Lymphedema Compression Nonsegmented (E0650)/Segmented (E0651) compressor Changed "Exercise" to "Exercise program/documented contraindication to exercise" under "Failed conservative decongestion therapy 4 wks" for "Stage II/Stage III refractory lymphedema" Exercise should be part of the decongestive therapies used to treat lymphedema. Patients not able to participate in an exercise program as part of the decongestive therapies should have documentation that exercise is contraindicated. Lymphedema Compression Segmented compressor with calibrated gradient pressure (E0652) Changed "Chronic venous insufficiency with lower extremity ulceration" to "Chronic venous insufficiency with non healing lower extremity ulceration and continuous treatment 6 mos" and added the required continuous treatment, which includes "Appropriate wound care for ulcer," "Trial of compression bandaging /stockings," "Exercise program/documented contraindication to exercise," and "Extremity elevation" This change clarifies the appropriate conservative treatment for chronic venous insufficiency with non healing lower extremity ulceration prior to the application of a segmented compressor with calibrated gradient pressure. Lymphedema Compression Segmented compressor with calibrated gradient pressure (E0652) Added "Traumatic injury" under the clinical presentation for "Stage II/Stage III refractory lymphedema" A severe traumatic injury in which the lymphatic system is interrupted and/or damaged in any way may trigger the onset of lymphedema. Lymphedema Compression Segmented compressor with calibrated gradient pressure (E0652) Changed "Exercise" to "Exercise program/documented contraindication to exercise" under "Failed conservative decongestion therapy 4 wks" for "Stage II/Stage III refractory lymphedema" Exercise should be part of the decongestive therapies used to treat lymphedema. Patients not able to participate in an exercise program as part of the decongestive therapies should have documentation that exercise is contraindicated. Lymphedema Compression Nonsegmented (E0650)/Segmented (E0651) compressor Changed "Chronic venous insufficiency with lower extremity ulceration" to "Chronic venous insufficiency with non healing lower extremity ulceration and continuous treatment 6 mos" and added the required continuous treatment, which includes "Appropriate wound care for ulcer," "Trial of compression bandaging /stockings," "Exercise program/documented contraindication to exercise," and "Extremity elevation" This change clarifies the appropriate conservative treatment for chronic venous insufficiency with non healing lower extremity ulceration prior to the application of a nonsegmented or segmented compressor. Lymphedema Compression Nonsegmented (E0650)/Segmented (E0651) compressor Changed "Exercise" to "Exercise program/documented contraindication to exercise" under "Failed conservative decongestion therapy 4 wks" for "Stage II/Stage III refractory lymphedema" Exercise should be part of the decongestive therapies used to treat lymphedema. Patients not able to participate in an exercise program as part of the decongestive therapies should have documentation that exercise is contraindicated. Page 7 of 20

8 Lymphedema Compression Segmented compressor with calibrated gradient pressure (E0652) Changed "Chronic venous insufficiency with lower extremity ulceration" to "Chronic venous insufficiency with non healing lower extremity ulceration and continuous treatment 6 mos" and added the required continuous treatment, which includes "Appropriate wound care for ulcer," "Trial of compression bandaging /stockings," "Exercise program/documented contraindication to exercise," and "Extremity elevation" This change clarifies the appropriate conservative treatment for chronic venous insufficiency with non healing lower extremity ulceration prior to the application of a segmented compressor with calibrated gradient pressure. Lymphedema Compression Segmented compressor with calibrated gradient pressure (E0652) Changed "Exercise" to "Exercise program/documented contraindication to exercise" under "Failed conservative decongestion therapy 4 wks" for "Stage II/Stage III refractory lymphedema" Exercise should be part of the decongestive therapies used to treat lymphedema. Patients not able to participate in an exercise program as part of the decongestive therapies should have documentation that exercise is contraindicated. Negative Pressure Wound Therapy (NPWT) Pump NPWT initial application (E2402) Added "Pre-albumin 16 mg/dl" and "Pre-albumin 10.0 to 15.9 mg/dl and nutritional supplements" under "Adequate nutrition for healing" for "Stage lll/lv pressure ulcer," "Diabetic ulcer," "Venous ulcer," "Arterial ulcer," and "Chronic ulcer/wound" Serum albumin is frequently measured, but has a long half-life (12 to 21 days) and is not sensitive to recent changes in a patient's dietary intake. Pre-albumin has a short half-life (2 days) and may be a better measure of the patient's response to nutritional interventions. Negative Pressure Wound Therapy (NPWT) Pump NPWT initial application (E2402) Added "Pre-albumin 16 mg/dl" and "Pre-albumin 10.0 to 15.9 mg/dl and nutritional supplements" under "Adequate nutrition for healing" for "Stage lll/lv pressure ulcer," "Diabetic ulcer," "Venous ulcer," "Arterial ulcer," and "Chronic ulcer" Serum albumin is frequently measured, but has a long half-life (12 to 21 days) and is not sensitive to recent changes in a patient's dietary intake. Pre-albumin has a short half-life (2 days) and may be a better measure of the patient's response to nutritional interventions. Negative Pressure Wound Therapy (NPWT) Pump NPWT initial application (E2402) Added "Failed trial of appropriate pressure reducing positioning/surfaces 2 wks" under "Stage lll/lv pressure ulcer" Pressure reducing positioning or pressure reducing surfaces should be attempted prior to requesting a negative pressure wound therapy pump for a stage lll/lv pressure ulcer. Added "Auto-titrating Continuous Positive Airway Pressure (APAP)" to the alternate name note. Auto-titrating Continuous Positive Airway Pressure (APAP) is another type of CPAP device that is used to treat patients with obstructive sleep apnea. Continuous positive (CPAP) device (E0601) Changed "Obstructive sleep apnea Dx by polysomnogram" to "Obstructive sleep apnea Dx by" and added criteria for diagnosis by both "Clinical evaluation" and "Attended facility-based polysomnogram/home sleep test" This change clarifies the criteria and aligns with current medical guidelines which state that the diagnosis of obstructive sleep apnea is made based on a complete history and physical exam, in combination with the findings identified by either a facilitybased polysomnogram or home sleep testing. Page 8 of 20

9 Continuous positive (CPAP) device (E0601) Added "Surgical evaluation" under "Pediatric clinical presentation" In most children with obstructive sleep apnea and adenotonsillar hypertrophy, adenotonsillectomy is the recommended first-line treatment. Evaluation for surgery should precede application of CPAP therapy. Changed "Progressive neuromuscular condition" to "Neuromuscular condition" This change aligns with current guidelines and includes patients with neuromuscular disorders that are not considered progressive. Changed "FVC < 50% predicted" to "FVC < 50% of predicted value by spirometry" This change clarifies the criteria point and defines FVC as a measurement obtained during spirometry. Changed "Thoracic expansion limited" to "Thoracic expansion limited/restrictive lung disease" This inclusion better reflects current medical terminology. Added "Hypoventilation syndrome" under clinical presentation Hypoventilation syndrome can be attributed to decreased alveolar ventilation as a result of decreased respiratory drive (e.g., opiate, benzodiazepines, or other sedative medication administration), worsening respiratory mechanics (e.g., neuromuscular disorders, obesity), or severe impairment in gas exchange from diseases that increase physiologic dead space (e.g., pulmonary HTN, interstitial pneumonia, ARDS). These patients may be appropriate for a bilevel positive airway pressure device without backup rate. backup rate (E0471, E0472) Changed "Progressive neuromuscular condition" to "Neuromuscular condition" This change aligns with current guidelines and includes patients with neuromuscular disorders that are not considered progressive. backup rate (E0471, E0472) Changed "FVC < 50% predicted" to "FVC < 50% of predicted value by spirometry" This change clarifies the criteria point and defines FVC as a measurement obtained during spirometry. Page 9 of 20

10 backup rate (E0471, E0472) Changed "Thoracic expansion limited" to "Thoracic expansion limited/restrictive lung disease" This inclusion better reflects current medical terminology backup rate (E0471, E0472) Added "Hypoventilation syndrome" under clinical presentation Hypoventilation syndrome can be attributed to decreased alveolar ventilation as a result of decreased respiratory drive (e.g., opiate, benzodiazepines, or other sedative medication administration), worsening respiratory mechanics (e.g., neuromuscular disorders, obesity), or severe impairment in gas exchange from diseases that increase physiologic dead space (e.g., pulmonary HTN, interstitial pneumonia, ARDS). These patients may be appropriate for a bilevel positive airway pressure device with backup rate. Added "Auto-titrating Continuous Positive Airway Pressure (APAP)" to the alternate name note. Auto-titrating Continuous Positive Airway Pressure (APAP) is another type of CPAP device that is used to treat patients with obstructive sleep apnea. Continuous positive (CPAP) device (E0601) Combined " 3 mos of use" with "Documented adherence to prescribed Rx" under "Ongoing application" Enhances usability and promotes consistency across subsets. Added "Documented understanding of proper use and care of equipment" Understanding the proper use and care of the equipment is important for patient compliance and is required documentation by CMS. Changed "Failed therapeutic trial with CPAP" to "Documented failure of therapeutic trial with CPAP" and added criteria to define trial This documentation of specified findings is required by CMS to confirm a CPAP trial has failed. Changed "CPAP failed to improve daytime symptoms of sleep-disordered breathing" to "Documented failure of therapeutic trial with CPAP" and added criteria to define trial This documentation of specified findings is required by CMS to confirm a CPAP trial has failed. Page 10 of 20

11 Changed "Progressive neuromuscular condition w/o significant COPD" to "Neuromuscular condition w/o significant COPD" This change aligns with current guidelines and includes patients with neuromuscular disorders that are not considered progressive. Changed "FVC < 50% predicted" to "FVC < 50% of predicted value by spirometry" This change clarifies the criteria point and defines FVC as a measurement obtained during spirometry. Changed "Usual FIO2" to "Prescribed FIO2" This change requires that O2 saturation measurements be taken with the patient on the FIO2 setting prescribed by the treating physician. Changed "Obstructive sleep apnea ruled out" to "Obstructive sleep apnea and treatment with CPAP ruled out" This change clarifies the requirements set forth by CMS to confirm that treatment with a CPAP device was ruled out before initiating BiPAP therapy. Changed "Thoracic expansion limited w/o significant COPD" to "Thoracic expansion limited/restrictive lung disease w/o significant" This inclusion better reflects current medical terminology. Added "Hypoventilation syndrome" under clinical presentation Hypoventilation syndrome can be attributed to decreased alveolar ventilation as a result of decreased respiratory drive (e.g., opiate, benzodiazepines, or other sedative medication administration), worsening respiratory mechanics (e.g., neuromuscular disorders, obesity), or severe impairment in gas exchange from diseases that increase physiologic dead space (e.g., pulmonary HTN, interstitial pneumonia, ARDS). These patients may be appropriate for a bilevel positive airway pressure device without backup rate. Added "Documented adherence to prescribed treatment 3 mos use" This change clarifies the requirements set forth by CMS guidelines which require an initial coverage period of 3 months with documented compliance before approving ongoing device use. Page 11 of 20

12 Changed "Documented Sx improvement with device use" for Ongoing application to "Clinical evaluation and documented symptom improvement with prescribed Rx" This change clarifies the requirements set forth by CMS and emphasizes the importance of a repeat clinical evaluation in determining the ongoing need for BiPAP without a backup rate. backup rate (E0471) Added "Documented understanding of proper use and care of equipment" Understanding the proper use and care of the equipment is important for patient compliance and is required documentation by CMS. backup rate (E0471) Changed "CPAP failed to improve daytime symptoms of sleep-disordered breathing" to "Documentation of failed therapeutic trial with CPAP" and added criteria to define trial This documentation of specified findings is required by CMS to confirm a CPAP trial has failed. backup rate (E0471) Changed "Progressive neuromuscular condition w/o significant COPD" to "Neuromuscular condition w/o significant COPD" This change aligns with current guidelines and includes patients with neuromuscular disorders that are not considered progressive. backup rate (E0471) Changed "FVC < 50% predicted" to "FVC < 50% of predicted value by spirometry" This change clarifies the criteria point and defines FVC as a measurement obtained during spirometry. backup rate (E0471) Changed "Usual FIO2" to "Prescribed FIO2" This change requires that O2 saturation measurements be taken with the patient on the FIO2 setting prescribed by the treating physician. backup rate (E0471) backup rate (E0471) Under COPD added "Bilevel device w/o back-up rate used 4 hrs/day < 61 days" These criteria cover patients who require a bilevel device with a backup rate before the 61 days of initial use is completed. Changed "Thoracic expansion limited w/o significant COPD" to "Thoracic expansion limited/restrictive lung disease w/o significant" This inclusion better reflects current medical terminology. Page 12 of 20

13 backup rate (E0471) Added "Hypoventilation syndrome" under clinical presentation Hypoventilation syndrome can be attributed to decreased alveolar ventilation as a result of decreased respiratory drive (e.g., opiate, benzodiazepines, or other sedative medication administration), worsening respiratory mechanics (e.g., neuromuscular disorders, obesity), or severe impairment in gas exchange from diseases that increase physiologic dead space (e.g., pulmonary HTN, interstitial pneumonia, ARDS). These patients may be appropriate for a bilevel positive airway pressure device with backup rate. backup rate (E0471) Added "Documented adherence to prescribed treatment 3 mos use" This change clarifies the requirements set forth by CMS guidelines which require an initial coverage period of 3 months with documented compliance before approving ongoing device use. backup rate (E0471) Changed "Documented Sx improvement with device use" to "Clinical evaluation and documented symptom improvement with prescribed Rx" This change clarifies the requirements set forth by CMS and emphasizes the importance of a repeat clinical evaluation in determining the ongoing need for BiPAP with a backup rate. Patient Lift Multi positional transfer system (E1035, E1036) Added "Patient weight" under "Clinical presentation" to clarify the appropriate HCPCS code for this equipment The HCPCS code E1035 is for patients less than or equal to 300 pounds, while E1036 is for patients greater than 300 pounds. Patient Lift Patient lift (E0630, E0635, E0639, E0640) Changed "Hydraulic mobile lift (E0630)" to "Patient lift (E0630, E0635, E0639, E0640)" Change reflects equipment included in CMS coverage determination. Patient Lift Multi positional transfer system (E1035, E1036, E0636) Changed "Multi-positional transfer system (E1035)" to "Multi-positional transfer system (E1035, E1036, E0636)" CMS coverage determination includes lifts for patients > 300 lbs (E1036) and lifts with patient accessible controls (E0636). Patient Lift Multi positional transfer system (E1035, E1036, E0636) Added Patient weight under Clinical presentation to clarify the appropriate HCPCS code for this equipment The HCPCS code E1035 is for patients less than or equal to 300 pounds, while E1036 is for patients greater than 300 pounds. Seat Lift Mechanism Seat lift mechanism (E0627 E0629) Added "Seat lift mechanism will improve function or arrest/retard deterioration" The prescribed seat lift mechanism should be part of the ordering physician's treatment of the patient's disease or condition with the goal of improving, stopping, or slowing the deterioration process, and improving the patient's functional mobility and safety. Page 13 of 20

14 Seat Lift Mechanism Seat lift mechanism (E0627 E0629) Added "Seat lift mechanism will improve function or arrest/retard deterioration" The prescribed seat lift mechanism should be part of the ordering physician's treatment of the patient's disease or condition with the goal of improving, stopping, or slowing the deterioration process, and improving the patient's functional mobility and safety. Spinal Orthoses, Thoracolumbosac ral (TLSO)/Lumbosac ral (LSO) Changed subset title from "Spinal Orthoses, Thoracolumbosacral (TLSO)/Lumbosacral (LSO)" to "Spinal Orthoses, Thoracolumbosacral (TLSO)/Lumbosacral (LSO)/Lumbar (LO) The criteria address prefabricated or custom fitted lumbar orthoses. Spinal Orthoses, Thoracolumbosac ral (TLSO)/Lumbosac ral (LSO) Prefabricated/custom fitted TLSO/LSO/LO (L0450, L0454, L0456, L0458, L0460, L0462, L0464, L0466, L0468, L0470, L0472, L0488, L0490, L0491, L0492, L0625, L0626, L0627, L0628, L0630, L0631, L0633, L0635, L0637, L0639) Changed the indication for "Prefabricated/custom fitted TLSO/LSO" to "Prefabricated/custom fitted TLSO/LSO/LO" The criteria address prefabricated or custom fitted lumbar orthoses. Support Surfaces Added "Documented comprehensive treatment plan" to "Overlay, nonpowered (E0185, E0197-E0199)," "Overlay, powered (E0181, E0182)," and "Mattress, nonpowered (E0184, E0186, E0187, E0196)" A care plan should be documented in the medical record for an individual on a group 1 support surface. This plan should include education on the prevention and management of pressure ulcers and address the appropriate needs of the patient. Support Surfaces Changed "Large/multiple stage lll/lv pressure ulcers on trunk/pelvis" to "Large/multiple stage lll/lv pressure ulcers on trunk/pelvis and documentation of comprehensive ulcer treatment program" for "Overlay, advanced nonpowered (E0371),"Overlay, advanced powered (E0372)," "Mattress, advanced nonpowered (E0373)," "Mattress, powered (E0277)," "Low air-loss bed (E0193)" When support surfaces are requested patients with large or multiple stage III or IV pressure ulcers on their trunk or pelvis should have documentation of a comprehensive ulcer treatment program that includes education on the prevention and management of pressure ulcers; regular assessments by a nurse, physician or other qualified healthcare practitioner; a turning and positioning schedule; appropriate wound care; management of moisture and incontinence; and nutritional assessment. Page 14 of 20

15 Support Surfaces Changed "Ulcer treatment program 4 wks and use of group 1 support surface" to "Documented comprehensive ulcer treatment program 4 wks and use of group 1 support surface" for "Overlay, advanced nonpowered (E0371), "Overlay, advanced powered (E0372)," "Mattress, advanced nonpowered (E0373)," "Mattress, powered (E0277)," "Low air-loss bed (E0193)" A care plan should be documented in the medical record for an individual on a group 2 support surface. This plan should include education on the prevention and management of pressure ulcers and address the appropriate needs of the patient. Support Surfaces Changed "Use of group 2 or 3 support surface prior to discharge from hospital/nursing facility" to "Use of group 2 or 3 support surface at discharge from hospital/nursing facility" for "Overlay, advanced nonpowered (E0371), "Overlay, advanced powered (E0372)," "Mattress, advanced nonpowered (E0373)," "Mattress, powered (E0277)," "Low air-loss bed (E0193)" Patients may use a support surface at various points during an admission. In order to meet criteria for any group 2 or 3 surface in the home, they must have been using one of these surfaces immediately before they were discharged home. Support Surfaces Air fluidized bed (E0194) Changed "Ulcer treatment program 4 wks with ulcer nonhealing/worsening" to "Documented comprehensive ulcer treatment program 4 wks with ulcer nonhealing/worsening" A care plan should be documented in the medical record for an individual on a group 3 support surface. This plan should include education on the prevention and management of pressure ulcers and address the appropriate needs of the patient. Support Surfaces Added "Documented comprehensive treatment plan" to "Overlay, nonpowered (E0185, E0197-E0199)," "Overlay, powered (E0181, E0182)," and "Mattress, nonpowered (E0184, E0186, E0187, E0196)" A care plan should be documented in the medical record for an individual on a group 1 support surface. This plan should include education on the prevention and management of pressure ulcers and address the appropriate needs of the patient. Support Surfaces Changed "Ulcer treatment program 4 wks and use of group 1 support surface" to "Documented comprehensive ulcer treatment program 4 wks and use of group 1 support surface" for "Overlay, advanced nonpowered (E0371), "Overlay, advanced powered (E0372)," "Mattress, advanced nonpowered (E0373)," "Mattress, powered (E0277)," "Low air-loss bed (E0193)" A care plan should be documented in the medical record for an individual on a group 2 support surface. This plan should include education on the prevention and management of pressure ulcers and address the appropriate needs of the patient. Page 15 of 20

16 Support Surfaces Changed "Use of group 2 or 3 support surface prior to discharge from hospital/nursing facility" to "Use of group 2 or 3 support surface at discharge from hospital/nursing facility" for "Overlay, advanced nonpowered (E0371), "Overlay, advanced powered (E0372)," "Mattress, advanced nonpowered (E0373)," "Mattress, powered (E0277)," "Low air-loss bed (E0193)" Patients may use a support surface at various points during an admission. In order to meet criteria for any group 2 or 3 surface in the home, they must have been using one of these surfaces immediately before they were discharged home. Support Surfaces Air fluidized bed (E0194) Changed "Ulcer treatment program 4 wks with ulcer nonhealing/worsening" to "Documented comprehensive ulcer treatment program 4 wks with ulcer nonhealing/worsening" A care plan should be documented in the medical record for an individual on a group 3 support surface. This plan should include education on the prevention and management of pressure ulcers and address the appropriate needs of the patient. (TENS) Restructured indication This indication was restructured to enhance usability. Criteria are presented for "Trial application" or "Ongoing application." Specific criteria for a two lead unit verses a four lead unit have been added. (TENS) Changed "Diagnosis and the specific diagnoses to "Etiology of " with the options for "Musculoskeletal" or "Neurogenic" This change allows of either a musculoskeletal or neurogenic etiology to be treated with TENS therapy if medications and other -relieving modalities have failed. Notes have been attached to give examples of musculoskeletal and neurogenic etiologies that may respond to TENS therapy. (TENS) Added "TENS" with the option for a "2 lead unit" or a "4 lead unit" TENS units with two leads are usually the recommended treatment. Criteria are also provided to address the need for a 4 lead unit. (TENS) (TENS) (TENS) Changed "Trial period lasting 30 to 60 days completed" to "30 day TENS trial completed" under "Ongoing application" A 30 day trial period is adequate in assessing the effectiveness of TENS therapy. Added "TENS reevaluation documented" under "Ongoing application" A reevaluation of the patient's symptoms is required to document that the TENS therapy has been effective and should continue. Changed "TENS used 3 days/wk" to "TENS use daily" Treatment with TENS is generally at least once a day. Page 16 of 20

17 (TENS) (TENS) (TENS) Acute postoperative Added "TENS" with the option for a "2 lead unit" or a "4 lead unit" Added "TENS" with the option for a "2 lead unit" or a "4 lead unit" Restructured indication TENS units with two leads are usually the recommended treatment. Criteria are also provided to address the need for a 4 lead unit. TENS units with two leads are usually the recommended treatment. Criteria are also provided to address the need for a 4 lead unit. This indication was restructured to enhance usability. Criteria are presented for "Trial application" or "Ongoing application." Specific criteria for a two lead unit verses a four lead unit have been added. (TENS) Changed "Diagnosis and the specific diagnoses to "Etiology of " with the options for "Musculoskeletal" or "Neurogenic" This change allows of either a musculoskeletal or neurogenic etiology to be treated with TENS therapy if medications and other relieving modalities have failed. Notes have been attached to give examples of musculoskeletal and neurogenic etiologies that may respond to TENS therapy. (TENS) Added "TENS" with the option for a "2 lead unit" or a "4 lead unit" TENS units with two leads are usually the recommended treatment. Criteria are also provided to address the need for a 4 lead unit. (TENS) (TENS) Added "TENS reevaluation documented" under "Ongoing application" A reevaluation of the patient's symptoms is required to document that the TENS therapy has been effective and should continue. Added "TENS" with the option for a "2 lead unit" or a "4 lead unit" TENS units with two leads are usually the recommended treatment. Criteria are also provided to address the need for a 4 lead unit. (TENS) Acute postoperative Added "TENS" with the option for a "2 lead unit" or a "4 lead unit" TENS units with two leads are usually the recommended treatment. Criteria are also provided to address the need for a 4 lead unit. Skin protection cushion (E2603, E2604, E2622, E2623) Changed "Current pressure ulcer" to "Current pressure ulcer on the area of contact with seating surface" Page 17 of 20

18 Skin protection cushion (E2603, E2604, E2622, E2623) Changed "Hx of pressure ulcer" to "Hx of pressure ulcer on the area of contact with the seating surface" Skin protection cushion (E2603, E2604, E2622, E2623) Changed "Ineffective weight shifts due to abnormal muscle tone or weakness of trunk/lower extremity" to "Ineffective weight shifts due to abnormal muscle tone or weakness of trunk/extremities" under "Risk for skin breakdown" A person may have upper extremity weakness that prevents them from effectively "pushing up" and easing weight and pressure on their buttocks or hips. Skin protection and positioning cushion (E2607, E2608, E2624, E2625) Skin protection and positioning cushion (E2607, E2608, E2624, E2625) Skin protection and positioning cushion (E2607, E2608, E2624, E2625) Skin protection and positioning cushion (E2607, E2608, E2624, E2625) Changed "Current skin breakdown/risk for skin breakdown" to "Skin protection needs due to" Enhances usability as structure for skin protection is consistent throughout criteria. Changed "Current pressure ulcer" to "Current pressure ulcer on the area of contact with the seating surface" Changed "Hx of pressure ulcer" to "Hx of pressure ulcer on the area of contact with the seating surface" Changed "Ineffective weight shifts due to abnormal muscle tone or weakness of trunk/lower extremity" to "Ineffective weight shifts due to abnormal muscle tone or weakness of trunk/extremities" under "Risk for skin breakdown" A person may have upper extremity weakness that prevents them from effectively "pushing up" and easing weight and pressure on their buttocks or hips. Custom fabricated wheelchair cushion Changed "Skin protection/positioning needs due to" to "Need for wheelchair cushion" This enhances usability by defining specific criteria for skin protection and positioning. Custom fabricated wheelchair cushion Changed "Current pressure ulcer" to "Current pressure ulcer on the area of contact with the seating surface" Page 18 of 20

19 Custom fabricated wheelchair cushion Changed "Hx of pressure ulcer" to "Hx of pressure ulcer on the area of contact with the seating surface" Custom fabricated wheelchair cushion Changed "Ineffective weight shifts due to abnormal muscle tone or weakness of trunk/lower extremity" to "Ineffective weight shifts due to abnormal muscle tone or weakness of trunk/extremities" under "Risk for skin breakdown" A person may have upper extremity weakness that prevents them from effectively "pushing up" and easing weight and pressure on their buttocks or hips. Skin protection cushion (E2603, E2604, E2622, E2623) Changed "Current pressure ulcer" to "Current pressure ulcer on the area of contact with seating surface" Skin protection cushion (E2603, E2604, E2622, E2623) Changed "Hx of pressure ulcer" to "Hx of pressure ulcer on the area of contact with seating surface." Skin protection cushion (E2603, E2604, E2622, E2623) Changed "Ineffective weight shifts due to abnormal muscle tone or weakness of trunk/lower extremity" to "Ineffective weight shifts due to abnormal muscle tone or weakness of trunk/extremities" A person may have upper extremity weakness that prevents them from effectively "pushing up" and easing weight and pressure on their buttocks or hips. Skin protection and positioning cushion (E2607, E2608, E2624, E2625) Skin protection and positioning cushion (E2607, E2608, E2624, E2625) Skin protection and positioning cushion (E2607, E2608, E2624, E2625) Changed "Current skin breakdown/risk for skin breakdown" to "Skin protection needs due to" Enhances usability as structure for skin protection is consistent throughout criteria. Changed "Current pressure ulcer" to "Current pressure ulcer on the area of contact with the seating surface" Changed "Hx of pressure ulcer" to "Hx of pressure ulcer on the area of contact with the seating surface" Page 19 of 20

20 Skin protection and positioning cushion (E2607, E2608, E2624, E2625) Changed "Ineffective weight shifts due to abnormal muscle tone or weakness of trunk/lower extremity" to "Ineffective weight shifts due to abnormal muscle tone or weakness of trunk/extremities" A person may have upper extremity weakness that prevents them from effectively "pushing up" and easing weight and pressure on their buttocks or hips. Custom fabricated wheelchair cushion Changed "Skin protection/positioning needs due to" to "Need for wheelchair cushion" This enhances usability by defining specific criteria for skin protection and positioning. Custom fabricated wheelchair cushion Changed "Current pressure ulcer" to "current pressure ulcer on the area of contact with the seating surface" Custom fabricated wheelchair cushion Changed "Hx of pressure ulcer" to "Hx of pressure ulcer on the area of contact with the seating surface" Custom fabricated wheelchair cushion Changed "Ineffective weight shifts due to abnormal muscle tone or weakness of trunk/lower extremity" to "Ineffective weight shifts due to abnormal muscle tone or weakness of trunk/extremities" A person may have upper extremity weakness that prevents them from effectively "pushing up" and easing weight and pressure on their buttocks or hips. Page 20 of 20