Monday, February 11, 2019

CPT code 31660, 31661 - Bronchial Thermoplasty

Coding Code Description CPT

31660 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial thermoplasty, 1 lobe

31661 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial thermoplasty, 2 or more lobes


Bronchial Thermoplasty


Introduction


Asthma is a long-term lung condition causing the airways of the lung to become inflamed. Inhaling certain substances such as tobacco smoke, pet dander, and dust mites can set off a chain reaction. One thing that happens during this chain reaction is that muscles around the airways constrict (tighten). This makes the airways narrower, which means less air gets into the lungs. This results in wheezing, tightness in the chest, coughing, and shortness of breath. Bronchial thermoplasty is one proposed treatment for asthma. The idea is that if there was less smooth muscle tissue around the airways, there would also be less airway constriction and fewer asthma attacks. Heat, delivered through an instrument known as a bronchoscope, is used to destroy the smooth muscle tissue. Bronchial thermoplasty is investigational (unproven). There are no long-term studies to show how well this treatment works. Longer studies are needed to see if it’s safe and effective.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.


Service Investigational Bronchial thermoplasty Bronchial thermoplasty for the treatment of asthma is considered investigational.



Evidence Review Description

Bronchial thermoplasty is a potential treatment option for patients with severe persistent asthma. It consists of radiofrequency energy delivered to the distal airways, with the aim of decreasing smooth muscle mass believed to be associated with airway inflammation.


Background Asthma

Asthma, a chronic lung disease, affects approximately 8.3% of adults and 8.3% of children in the United States and, in 2017, accounted for approximately 1.7 million emergency department visits and 3615 deaths.1 Asthma symptoms include episodic shortness of breath that is generally  associated with other symptoms such as wheezing, coughing, and chest tightness. Objective clinical features include bronchial hyperresponsiveness, airway inflammation, and reversible airflow obstruction (at least 12% improvement in forced expiratory volume in 1 second postbronchodilator, with a minimum of 200 mL improvement). However, there is substantial heterogeneity in the inflammatory features of patients diagnosed with asthma, and this biologic diversity is responsible, at least in part, for the variable response to treatment in the asthma population.

Management

Management of asthma consists of environmental control, patient education, management of comorbidities, and regular follow-up for all affected patients, as well as a stepped approach to medication treatment. Guidelines from the National Heart, Lung and Blood Institute have defined 6 pharmacologic steps: step 1 for intermittent asthma and steps 2 through 6 for persistent asthma.2 The preferred daily medications: step 1: short-acting ?-agonists as-needed;
step 2: low-dose inhaled corticosteroids (ICS); step 3: ICS and long-acting ?-agonists (LABA) or medium-dose ICS; step 4: medium-dose ICS and LABA; step 5: high-dose ICS and LABA; and
step 6: high-dose ICS and LABA, and oral corticosteroids.

Despite this multidimensional approach, many patients continue to experience considerable morbidity. In addition to ongoing efforts to implement optimally standard approaches to asthma treatment, new therapies are being developed. One recently developed therapy is bronchial thermoplasty, the controlled delivery of radiofrequency energy to the heat tissues in the distal airways. Bronchial thermoplasty is based on the premise that patients with asthma have an increased amount of smooth muscle in their airways and that contraction of this smooth muscle is a major cause of airway constriction. The thermal energy delivered via bronchial thermoplasty aims to reduce the amount of smooth muscle and thereby decrease musclemediated bronchoconstriction with the ultimate goal of reducing asthma-related morbidity. Bronchial thermoplasty is intended as a supplemental treatment for patients with severe persistent asthma (ie, steps 5 and 6 in the stepwise approach to care).


Bronchial thermoplasty procedures are performed on an outpatient basis, and each session lasts approximately 1 hour. During the procedure, a standard flexible bronchoscope is placed through the patient’s mouth or nose into the most distal targeted airway, and a catheter is inserted into the working channel of the bronchoscope. After placement, the electrode array in the top of the catheter is expanded, and radiofrequency energy is delivered from a proprietary controller and used to heat tissue to 65?C over a 5mm area. The positioning of the catheter and application of thermal energy is repeated several times in contiguous areas along the accessible length of the airway. At the end of the treatment session, the catheter and bronchoscope are removed. A course of treatment consists of 3 separate procedures in different regions of the lung scheduled about 3 weeks apart.

Summary of Evidence

For individuals who have asthma refractory to standard treatment who receive bronchial thermoplasty added to medical management, the evidence includes 3 RCTs and observational studies. Relevant outcomes are symptoms, quality of life, hospitalizations, and treatment-related morbidity. Early studies (RISA, AIR) investigated safety outcomes, finding similar rates of adverse events and exacerbations between the bronchial thermoplasty and control groups. These trials were limited by their lack of sham control. The AIR2 trial is the largest of the 3 published RCTs, and the only one double-blinded and sham-controlled, with sites in the United States. Over 1 year, bronchial thermoplasty was not found to be superior to sham treatment on the investigator-designated primary efficacy outcome of mean change in the quality of life score but was found to be superior on a related outcome, improvement in the quality of life of at least 0.5 points on the AQLQ. There was a high response rate in the sham group of the AIR2 trial, suggesting a large placebo effect, particularly for subjective outcomes such as quality of life.

There are no long-term sham-controlled efficacy data. Findings on adverse events from the 3 trials have suggested that bronchial thermoplasty is associated with a relatively high rate of adverse events, including hospitalizations during the treatment period, but not in the posttreatment period. Safety data up to 5 years have been reported in the RCTs for patients treated with bronchial thermoplasty but not for control patients. Safety data from a U.K. registry study, published in 2016, found that 20% of bronchial thermoplasty procedures were associated with a safety event (ie, procedural complications, emergency respiratory readmissions, emergency department visits, and/or postprocedure overnight stays). Conclusions cannot be drawn about the effect of bronchial thermoplasty on the net health outcome due to the limited amount of sham controlled data (1 RCT) on short-term efficacy, the uncertain degree of treatment benefit in that single sham-controlled trial, the lack of long-term sham controlled data in the face of a high initial placebo response, and the presence of substantial adverse events. Also, there is a lack of data on patient selection factors for   this procedure and, as a result, it is not possible to determine whether there are patient subgroups that might benefit. The evidence is insufficient to determinethe effects of the technology on health outcomes.

Friday, January 4, 2019

CPT 61885, 61886, 64553 - 54570 - L8679 - L8689

Coding Code Description CPT

61885 Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array
61886 Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to 2 or more electrode arrays
64553 Percutaneous implantation of neurostimulator electrodes; cranial nerve
64568 Incision for implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator
64569 Revision or replacement of cranial nerve (eg, vagus nerve) neurostimulator electrode array, including connection to existing pulse generator
64570 Removal of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator

HCPCS

L8679 Implantable neurostimulator, pulse generator, any type
L8680 Implantable neurostimulator electrode, each
L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only
L8682 Implantable neurostimulator radiofrequency receiver
L8683 Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver
L8684 Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management, replacement
L8685 Implantable neurostimulator pulse generator, single array, rechargeable, includes
L8686 Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension
L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
L8688 Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension
L8689 External recharging system for battery (internal) for use with implantable neurostimulator, replacement only
L8689 External recharging system for battery (internal) for use with implantable neurostimulator, replacement only


Occipital Nerve Stimulation

Introduction

The occipital nerves run through the muscles on the back of the head and over the scalp. Irritation to these nerves can create shooting or tingling pain, usually on one side of the head or near one eye. The scalp can also can be very painful to the touch. Occipital nerve stimulation is a being studied as a technique for migraines and other headaches that don’t respond to medication. Occipital nerve stimulation aims to treat pain with electrical signals. Wires are implanted at the base of the skull. The wires are connected to a small power source surgically placed below the skin, usually in the upper chest. The power source generates the electricity, which then sends the signal through the wires to stimulate the occipital nerve. It’s thought that the electrical signals block or scramble the pain signals from the nerves. Because more studies are needed to see if this technique is effective, occipital nerve stimulation is considered investigational (unproven).

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.


Policy Coverage Criteria Service Investigational Occipital nerve stimulation Occipital nerve stimulation is considered investigational for all indications.



Evidence Review Description


Occipital nerve stimulation delivers a small electrical charge to the occipital nerve in an attempt to prevent migraines and other headaches in patients who have not responded to medications.

The device consists of a subcutaneously implanted pulse generator (in the chest wall or abdomen) attached to extension leads that are tunneled to join electrodes placed across one or both occipital nerves at the base of the skull. Continuous or intermittent stimulation may be used.

Background Headache

There are 4 types of headache: vascular, muscle contraction (tension), traction, andinflammatory. Primary (not the result of another condition) chronic headache is defined as headache occurring more than 15 days of the month for at least 3 months. An estimated 45 million Americans experience chronic headaches. For at least half of these people, the problem is severe and sometimes disabling. Herein, we only discuss types of vascular headache, including migraine, hemicrania continua, and cluster.

Migraine

Migraine is the most common type of vascular headache. Migraine headaches are usually characterized by severe pain on one or both sides of the head, an upset stomach, and, at times, disturbed vision. One-year prevalence of migraine ranges from 6% to 15% in adult men and from 14% to 35% in adult women. Migraine headaches may last a day or more and can strike as often as several times a week or as rarely as once every few years.

Treatment


Drug therapy for migraine is often combined with biofeedback and relaxation training. Sumatriptan is commonly used for relief of symptoms. Drugs used to prevent migraine include amitriptyline, propranolol and other ß-blockers, topiramate and other antiepileptic drugs, and verapamil.

Hemicrania Continua

Hemicrania continua causes moderate pain with occasionally severe pain on only one side of the head. At least one of the following symptoms must also occur; conjunctival injection and/or lacrimation, nasal congestion and/or rhinorrhea, or ptosis and/or miosis. Headache occurs daily and is continuous with no pain-free periods. Hemicrania continua occur mainly in women, and its true prevalence is not known.


Treatment


Indomethacin usually provides rapid relief of symptoms. Other nonsteroidal anti-inflammatory drugs, including ibuprofen, celecoxib, and naproxen, can provide some relief from symptoms. Amitriptyline and other tricyclic antidepressants are effective in some patients.

Cluster Headache

Cluster headache occurs in cyclical patterns or clusters of severe or very severe unilateral orbital  or supraorbital and/or temporal pain. The headache is accompanied by at least one of thefollowing autonomic symptoms: ptosis (drooping eyelid), conjunctival injection, lacrimation, rhinorrhea, and, less commonly, facial blushing, swelling, or sweating. Bouts of 1 headache every other day up to 8 attacks per day may last from weeks to months, usually followed by remission periods when the headache attacks stop completely. The pattern varies by person, but most people have 1 or 2 cluster periods a year. During remission, no headaches occur for months, and sometimes even years. The intense pain is caused by the dilation of blood vessels, which creates pressure on the trigeminal nerve. While this process is the immediate cause of the pain, the etiology is not fully understood. It is common in men than in woman. One-year prevalence is estimated to be 0.5 to 1.0 in 1000.

Treatment

Management of cluster headache consists of abortive and preventive treatment. Abortive treatments include subcutaneous injection of sumatriptan, topical anesthetics sprayed into the nasal cavity, and strong coffee. Some patients respond to rapidly inhaled pure oxygen. A variety of other pharmacologic and behavioral methods of aborting and preventing attacks have been reported with wide variation in patient response.
Peripheral Nerve Stimulators

Implanted peripheral nerve stimulators have been used to treat refractory pain for many years, but have only recently been proposed to manage craniofacial pain. Occipital, supraorbital, and infraorbital stimulation have been reported in the literature.


Summary of Evidence

For individuals with migraine headaches refractory to preventive medical management who receive occipital nerve stimulation, the evidence includes randomized controlled trials (RCTs), a systematic review of RCTs, and observational studies. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Systematic review identified 5 sham-controlled RCTs. Findings from pooled analyses of these RCTs were mixed. For example, compared to placebo, response rates to occipital nerve stimulation did not differ significantly but did reduce the number of days with prolonged moderate-to-severe headache. Occipital nerve stimulation was also associated with a substantial number of minor and serious adverse events. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have non-migraine headaches (eg, hemicrania continua, cluster headaches) who receive occipital nerve stimulation, the evidence includes case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Many of the case series had small sample sizes; series with over 25 patients were available only for treatment of cluster headache. Although the case series tended to find that a substantial number of patients improved after occipital nerve stimulation, these studies lacked blinding and comparison groups. RCTs are needed to compare outcomes between occipital nerve stimulation and comparators (eg, to control for a potential placebo effect). The evidence is insufficient to determine the effects of the technology on health outcomes.

Monday, January 8, 2018

HOSPITAL-GRADE ELECTRIC BREAST PUMP - Medicaid Guide


Definition A hospital grade electric breast pump is heavy duty, piston-operated, and is capable of being used frequently on a daily basis.

Standards of Coverage

A hospital grade electric breast pump may only be covered for a beneficiary with a Neonatal Intensive Care Unit (NICU) infant, up to three months of age, when one of the following applies:

* The infant has a severe feeding problem secondary to cleft lip and/or palate.

* The infant has a severe feeding problem due to oral motor dysfunction, secondary to prematurity.

* The infant is hospitalized resulting in a physical separation of the mother and infant.

* The infant or mother is hospitalized, resulting in a physical separation of the mother and infant; and all of the following applies:

* The pump has an adjustable suction pressure at the breast shield during use between 30 mm Hg and 250 mm Hg (suction just at the low or high end is not acceptable);

* The pump has a mechanism to prevent suction beyond 250 mm Hg to prevent nipple trauma;

* The pump has an adjustable/varying pumping speed no less than 30 cycles per minute and capable of reaching up to a maximum of 60 cycles per minute;

* The pump must be able to operate on a 110-volt household current and be UL listed;

* The pump must not weigh over 12 pounds; and

* The pump is registered and cleared with the FDA.

For continued coverage beyond the initial three months, additional documentation must be provided.

Documentation Documentation must be less than 30 days old and include:

* Diagnosis/medical condition of the infant relating to the need for a breast pump.

* Infant's age (gestational age, if premature).

* Mother's discharge date.

* Anticipated duration of need.

* An order signed by the treating physician or non-physician practitioner.

* The International Classification of Diseases (ICD) diagnosis code(s) related to birth or pregnancy.

* Documentation of mother’s intent to breastfeed.

Documentation must be kept in the beneficiary’s file and made available upon request.

PA Requirements PA is not required when the Standards of Coverage are met.


PA is required for coverage beyond three months

Payment Rules A breast pump is considered a rental only item and is inclusive of the following:

* All related accessories necessary to use the equipment. (To obtain additional reimbursement for the initial breast pump kit, report the "KH" modifier with HCPCS code E0604 for the first month of rental only.)

* Education on the proper use and care of the equipment.

* Routine servicing and all necessary repairs or replacements to make the unit functional.

The rental pump may be billed using the infant's Medicaid ID number if the need for the hospital grade pump meets the standards of coverage and the mother loses Medicaid eligibility.

Rental of the hospital-grade electric breast pump will not be made if a personal use double electric breast pump or a manual breast pump was purchased for the beneficiary within the Standards of Coverage frequency limitations.


PERSONAL USE DOUBLE ELECTRIC BREAST PUMP

Definition A personal use double electric breast pump is defined as a double electric (AC and/or DC) pump, intended for a single user, capable of being used frequently on a daily basis.

Standards of Coverage

A personal use double electric breast pump may be covered once per five years for a beneficiary when all of the following criteria are met:

* The mother expresses the desire to breastfeed;

* The pump has been registered and cleared by the FDA;

* The pump has a minimum of a one-year manufacturer’s warranty;

* The pump has an adjustable suction pressure at the breast shield during use between 30 mm Hg and 250 mm Hg (suction just at the low or high end is not acceptable);

* The pump has a mechanism to prevent suction beyond 250 mm Hg to prevent nipple trauma;

* The pump has an adjustable/varying pumping speed no less than 30 cycles per minute and capable of reaching up to a maximum of 60 cycles per minute;

* The pump must be able to operate on a 110-volt household current and be UL listed;

* The pump must not weigh over 12 pounds; and

* The pump collection bottle must be bisphenol-A (BPA) and DHEP-free.



Documentation Must be less than 30 days old and include all of the following:

* An order signed by the treating physician or non-physician practitioner.

* The International Classification of Diseases (ICD) diagnosis code(s) related to birth or pregnancy.

* Infant’s age (gestational age, if premature).

* Mother’s hospital discharge date or infant’s hospital discharge date.

* Documentation of mother’s intent to breastfeed.

Documentation must be kept in the beneficiary’s file and made available upon request. PA Requirements PA is not required when the Standards of Coverage are met. PA is required for circumstances beyond the Standards of Coverage and Payment Rules.

Payment Rules All personal use double electric breast pumps are purchase only. Payment includes:

* Education for the proper use, care of the equipment, and storage of breast milk.

* Supplies necessary for operation of the pump (pump, adapter/charger, breast shields, bottles, lids, tubing, locking ring, connectors, valves, filters and membranes.

The pump may be billed using the infant’s Medicaid ID number if the need for the pump meets the Standards of Coverage and the mother loses Medicaid eligibility. Medicaid will not purchase a personal use double electric breast pump during the rental period of a hospital-grade electric breast pump or if a manual breast pump was purchased within the Standards of Coverage frequency limitations.

Replacement parts are covered after the manufacturer’s warranty has expired for included parts. Refer to the Medical Supplier database and the Medicaid Code and Rate Reference tool for covered replacement parts, code descriptions, coverage limitations and reimbursement.

 MANUAL BREAST PUMP

Definition A manual breast pump typically consists of a single breast shield, a collection device, and a hand-controlled lever to create suction and express milk. Manual breast pumps are intended for a single user.


Standards of Coverage

A manual breast pump may be covered once per birth. For a beneficiary who has had a multiple birth delivery, only one pump is covered. Coverage of a manual breast pump may be provided when all of the following criteria have been met:

* The mother expresses the desire to breastfeed.

* The pump has been registered with the FDA.

* The pump has a minimum of a one year manufacturer’s warranty.

* The pump has a mechanism to prevent suction beyond 250 mm Hg to prevent nipple trauma.

* The pump collection bottle must be bisphenol-A (BPA) and DHEP-free.


Definition Diabetic shoes, inserts and related modifications include, but are not limited to, depth inlay shoes, multi-density inserts, roller or rocker bottoms, wedges, metatarsal bar, and offset heel.


Standards of Coverage

Diabetic shoes, inserts, and/or modifications may be covered for individuals who have, due to complications with diabetes mellitus, one of the following conditions:

* History of previous foot ulcerations or pre-ulcerative calluses.

* Established peripheral neuropathy or sensory impairment.

* Peripheral Vascular Disease with an ankle brachial index at rest of 0.5 or less following exercise.

* Loss of a toe or portion of the foot due to amputation arising from diabetes.

A custom-molded diabetic shoe is covered only if the depth shoe cannot accommodate a foot anomaly.

Inserts are covered if the beneficiary requires a depth shoe or custom-molded diabetic shoe. For a depth shoe, three inserts would be separately reimbursable in addition to the noncustomized one included with the shoe. For a custom-molded shoe, two inserts would be separately reimbursable. Modifications to a custom-molded or depth shoe may be covered rather than an additional insert.


Documentation Documentation must be less than 30 days old and include all of the following:

* Diagnosis/medical condition related to the service requested.

* Medical reasons for specific shoe type and/or modification.

PA Requirements PA is not required for the following inserts if the Standards of Coverage are met:

* Multiple density insert, direct formed, molded to foot with external heat source.

* Multiple density insert, direct formed, compression molded to patient's foot without external heat source.

* Multiple density insert, custom fabricated and custom-molded from model of patient's foot.

* Depth inlay shoes.

* Modifications if an additional insert is not provided.



PA is required for:

* Medical need beyond the Standards of Coverage.

* Replacement within one year.

* Quantity beyond established limits.

* Custom-fabricated shoes and other inserts not included above. Payment Rules All items are considered purchase only.

Thursday, October 5, 2017

Which provider can bill Daily care, ANCILLARY PHYSICAL AND OCCUPATIONAL THERAPY, SPEECH PATHOLOGY


DAILY CARE

The following providers may bill for daily care and must enter the appropriate revenue code that identifies the specific daily care accommodation being billed:

* Nursing Home Facilities

* County Medical Care Facilities

* Hospital Long Term Care Units

* Hospital Swing Beds

* Ventilator Dependent Units

The NUBC Manual provides the revenue codes to be used for Michigan Medicaid.



ANCILLARY PHYSICAL AND OCCUPATIONAL THERAPY, SPEECH PATHOLOGY

The following providers may bill physical/occupational therapy and speech pathology:

* Nursing Home Facilities

* County Medical Care Facilities

* Hospital Long Term Care Units

* Outpatient County Medical Care Facilities

When billing on the NUBC claim form, facilities must use the revenue codes and HCPCS codes identified on the MDHHS Therapy Services Database available on the MDHHS website. (Refer to the Directory Appendix for website information.)

* Each ancillary service must be billed on a separate claim line. Series billing is not allowed.

* Each claim line requires a:

* Date of service

* Revenue code and a HCPCS code

* PA number on the claim

Dual-use therapy codes may be billed by a physical therapist and an occupational therapist on the same date of service when both professionals provide covered therapy services on the same day under their corresponding treatment plans. The codes are identified on the MDHHS Therapy Services Database with required modifiers GO and GP. The appropriate modifier must always be used on the claim line to avoid a claim rejection when billing a dual-use code.

* Occupational therapy modifier: GO

* Physical therapy modifier: GP


OUTPATIENT COUNTY MEDICAL CARE FACILITIES

* When billing for therapies, outpatient county medical care facilities must indicate the Type of Bill as 23X.

* Each service must be billed on a separate claim line. Series billing is not allowed.

* Each claim line requires a revenue code and a CPT/HCPCS code.

* Each claim requires a PA number to be reported in the appropriate form locator or electronic segment.

Sunday, March 26, 2017

CPT 90867, 90869 - RTMS for resistant depression

CPT/HCPCS Codes

Group 1 Paragraph: N/A

Group 1 Codes:
90867 Tcranial magn stim tx plan
90868 Tcranial magn stim tx deli
90869 Tcran magn stim redetemine


Coverage Indications, Limitations, and/or Medical Necessity

Background

Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive treatment that uses magnetic resonance pulsed fields to induce an electric current in the brain. Repetitive TMS can either decrease or increase the excitability of the targeted structures.

In 2008 the U.S. Food and Drug Administration (FDA) granted 510(k) marketing clearance as a de novo device for NeuroStar ® TMS to be utilized as a Class II rTMS device for the treatment of major depressive disorder in patients who had not responded to one adequate trial of antidepressant medication. A September 2011 AHRQ report “Nonpharmacologic Interventions for Treatment-Resistant Depression in Adults. Comparative Effectiveness Review” found that rTMS was beneficial relative to controls receiving a sham procedure for all three outcomes (severity of depressive symptoms, response rate, remission rate), with high strength of evidence for severity of depressive symptoms and response rate, and moderate strength of evidence for remission rate. The AHRQ report cites that relative to sham control, rTMS averaged a decrease in depressive severity measured by the Hamilton Rating Scale for Depression (HAM-D) of more than 5 points (a 3 point difference is considered clinically meaningful).

rTMS offers a well-tolerated, non-pharmacologic alternative that does not require attendant anesthesia services. When used as an antidepressant therapy, rTMS has no adverse effects on cognition, and unlike electroconvulsant therapy (ECT) does not induce amnesia or seizures. Comparative outcomes for ECT and rTMS are similar.

Indications

Left prefrontal rTMS is considered reasonable and necessary for patients diagnosed with resistant depression who also have at least one of the following:

Resistance to treatment with psychopharmacologic agents as evidenced by a lack of clinically significant response to four trials of such agents, in the current depressive episode, from at least two different agent classes. At least one of the treatment trials must have been administered at an adequate course of mono- or poly–drug therapy; or

Inability to tolerate psychopharmacologic agents as evidenced by trials of four such agents, from at least two different agent classes, with distinct side effects; or

History of good response to rTMS in a previous episode; or

If patient is currently receiving electro-convulsive therapy, rTMS may be considered reasonable and necessary as a less invasive treatment option.

Limitations

rTMS is considered not reasonable and necessary when used as a treatment modality for patients with psychotic symptoms.

Use of rTMS is not indicated in patients with:

Seizure disorder, or
A vagus nerve stimulator, or
An implanted medical device or metal in close proximity to the brain.

Bill Type Codes:
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
N/A

Revenue Codes:
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

N/A



ICD-10 CODE DESCRIPTION

F32.2 Major depressive disorder, single episode, severe without psychotic features
F33.2 Major depressive disorder, recurrent severe without psychotic features

Wednesday, March 15, 2017

Walker CPT code list


HCPCS CODES:


Group 1 Codes:

A4636 REPLACEMENT, HANDGRIP, CANE, CRUTCH, OR WALKER, EACH

A4637 REPLACEMENT, TIP, CANE, CRUTCH, WALKER, EACH.

A9270 NON-COVERED ITEM OR SERVICE

A9900 MISCELLANEOUS DME SUPPLY, ACCESSORY, AND/OR SERVICE COMPONENT OF ANOTHER HCPCS CODE

E0130 WALKER, RIGID (PICKUP), ADJUSTABLE OR FIXED HEIGHT

E0135 WALKER, FOLDING (PICKUP), ADJUSTABLE OR FIXED HEIGHT

E0140 WALKER, WITH TRUNK SUPPORT, ADJUSTABLE OR FIXED HEIGHT, ANY TYPE

E0141 WALKER, RIGID, WHEELED, ADJUSTABLE OR FIXED HEIGHT

E0143 WALKER, FOLDING, WHEELED, ADJUSTABLE OR FIXED HEIGHT

E0144 WALKER, ENCLOSED, FOUR SIDED FRAMED, RIGID OR FOLDING, WHEELED WITH POSTERIOR SEAT

E0147 WALKER, HEAVY DUTY, MULTIPLE BRAKING SYSTEM, VARIABLE WHEEL RESISTANCE

E0148 WALKER, HEAVY DUTY, WITHOUT WHEELS, RIGID OR FOLDING, ANY TYPE, EACH

E0149 WALKER, HEAVY DUTY, WHEELED, RIGID OR FOLDING, ANY TYPE

E0154 PLATFORM ATTACHMENT, WALKER, EACH

E0155 WHEEL ATTACHMENT, RIGID PICK-UP WALKER, PER PAIR

E0156 SEAT ATTACHMENT, WALKER

E0157 CRUTCH ATTACHMENT, WALKER, EACH

E0158 LEG EXTENSIONS FOR WALKER, PER SET OF FOUR (4)

E0159 BRAKE ATTACHMENT FOR WHEELED WALKER, REPLACEMENT, EACH

E1399 DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS


Coverage Guidance


Coverage Indications, Limitations, and/or Medical Necessity

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. For the items addressed in this local coverage determination, the criteria for "reasonable and necessary", based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

Medicare does not automatically assume payment for a durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) item that was covered prior to a beneficiary becoming eligible for the Medicare Fee For Service (FFS) program. When a beneficiary receiving a DMEPOS item from another payer (including Medicare Advantage plans) becomes eligible for the Medicare FFS program, Medicare will pay for continued use of the DMEPOS item only if all Medicare coverage, coding and documentation requirements are met. Additional documentation to support that the item is reasonable and necessary, may be required upon request of the DME MAC.

For an item to be covered by Medicare, a detailed written order (DWO) must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed DWO, the item will be denied as not reasonable and necessary.

A standard walker (E0130, E0135, E0141, E0143) and related accessories are covered if all of the following criteria (1-3) are met:

The beneficiary has a mobility limitation that significantly impairs his/her ability to participate in one or more mobility-related activities of daily living (MRADL) in the home.

A mobility limitation is one that:
Prevents the beneficiary from accomplishing the MRADL entirely, or

Places the beneficiary at reasonably determined heightened risk of morbidity or mortality secondary to the attempts to perform the MRADL, or

Prevents the beneficiary from completing the MRADL within a reasonable time frame; and

The beneficiary is able to safely use the walker; and

The functional mobility deficit can be sufficiently resolved with use of a walker.
If all of the criteria are not met, the walker will be denied as not reasonable and necessary.

A heavy duty walker (E0148, E0149) is covered for beneficiaries who meet coverage criteria for a standard walker and who weigh more than 300 pounds. If an E0148 or E0149 walker is provided and if the beneficiary weighs 300 pounds or less, it will be denied as not reasonable and necessary.

A heavy duty, multiple braking system, variable wheel resistance walker (E0147) is covered for beneficiaries who meet coverage criteria for a standard walker and who are unable to use a standard walker due to a severe neurologic disorder or other condition causing the restricted use of one hand. Obesity, by itself, is not a sufficient reason for an E0147 walker. If an E0147 walker is provided and if the additional coverage criteria are not met, it will be denied as not reasonable and necessary.

The medical necessity for a walker with an enclosed frame (E0144) has not been established. Therefore, if an enclosed frame walker is provided, it will be denied as not reasonable and necessary.

A walker with trunk support (E0140) is covered for beneficiaries who meet coverage criteria for a standard walker and who have documentation in the medical record justifying the medical necessity for the special features. If an E0140 walker is provided and if the medical record does not document why that item is medically necessary, it will be denied as not reasonable and necessary.

Leg extensions (E0158) are covered only for beneficiaries 6 feet tall or more.



Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
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Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

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CPT/HCPCS Codes

Group 1 Paragraph:
The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIERS:

EY – No physician or other licensed health care provider order for this item or service

GA – Waiver of liability statement issued as required by payer policy, individual case

GY – Item or service statutorily excluded or doesn’t meet the definition of any Medicare benefit category

GZ – Item or service expected to be denied as not reasonable and necessary

KX - Requirements specified in the medical policy have been met

Friday, March 3, 2017

Positive Airway pressure (PAP) devices cpt codes

HCPCS CODES:

EQUIPMENT:


Group 1 Codes:

E0470 RESPIRATORY ASSIST DEVICE, BI-LEVEL PRESSURE CAPABILITY, WITHOUT BACKUP RATE FEATURE, USED WITH NONINVASIVE INTERFACE, E.G., NASAL OR FACIAL MASK (INTERMITTENT ASSIST DEVICE WITH CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE)

E0471 RESPIRATORY ASSIST DEVICE, BI-LEVEL PRESSURE CAPABILITY, WITH BACK-UP RATE FEATURE, USED WITH NONINVASIVE INTERFACE, E.G., NASAL OR FACIAL MASK (INTERMITTENT ASSIST DEVICE WITH CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE)

E0601 CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE

Group 2 Paragraph: ACCESSORIES


Group 2 Codes:


A4604 TUBING WITH INTEGRATED HEATING ELEMENT FOR USE WITH POSITIVE AIRWAY PRESSURE DEVICE

A7027 COMBINATION ORAL/NASAL MASK, USED WITH CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE, EACH

A7028 ORAL CUSHION FOR COMBINATION ORAL/NASAL MASK, REPLACEMENT ONLY, EACH

A7029 NASAL PILLOWS FOR COMBINATION ORAL/NASAL MASK, REPLACEMENT ONLY, PAIR

A7030 FULL FACE MASK USED WITH POSITIVE AIRWAY PRESSURE DEVICE, EACH

A7031 FACE MASK INTERFACE, REPLACEMENT FOR FULL FACE MASK, EACH

A7032 CUSHION FOR USE ON NASAL MASK INTERFACE, REPLACEMENT ONLY, EACH

A7033 PILLOW FOR USE ON NASAL CANNULA TYPE INTERFACE, REPLACEMENT ONLY, PAIR

A7034 NASAL INTERFACE (MASK OR CANNULA TYPE) USED WITH POSITIVE AIRWAY PRESSURE DEVICE, WITH OR WITHOUT HEAD STRAP

A7035 HEADGEAR USED WITH POSITIVE AIRWAY PRESSURE DEVICE

A7036 CHINSTRAP USED WITH POSITIVE AIRWAY PRESSURE DEVICE

A7037 TUBING USED WITH POSITIVE AIRWAY PRESSURE DEVICE

A7038 FILTER, DISPOSABLE, USED WITH POSITIVE AIRWAY PRESSURE DEVICE

A7039 FILTER, NON DISPOSABLE, USED WITH POSITIVE AIRWAY PRESSURE DEVICE

A7044 ORAL INTERFACE USED WITH POSITIVE AIRWAY PRESSURE DEVICE, EACH

A7045 EXHALATION PORT WITH OR WITHOUT SWIVEL USED WITH ACCESSORIES FOR POSITIVE AIRWAY DEVICES, REPLACEMENT ONLY

A7046 WATER CHAMBER FOR HUMIDIFIER, USED WITH POSITIVE AIRWAY PRESSURE DEVICE, REPLACEMENT, EACH

E0561 HUMIDIFIER, NON-HEATED, USED WITH POSITIVE AIRWAY PRESSURE DEVICE

E0562 HUMIDIFIER, HEATED, USED WITH POSITIVE AIRWAY PRESSURE DEVICE


Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. For the items addressed in this local coverage determination, the criteria for "reasonable and necessary", based on Social Security Act §1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

Medicare does not automatically assume payment for a durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) item that was covered prior to a beneficiary becoming eligible for the Medicare Fee For Service (FFS) program. When a beneficiary receiving a DMEPOS item from another payer (including Medicare Advantage plans) becomes eligible for the Medicare FFS program, Medicare will pay for continued use of the DMEPOS item only if all Medicare coverage, coding and documentation requirements are met. Additional documentation to support that the item is reasonable and necessary, may be required upon request of the DME MAC.

While this Standard Documentation language makes reference to " Affordable Care Act Section 6407 (ACA 6407) requirements", technically these requirements are found in the Social Security Act Section 1843(a)(11)(B) and its implementing regulation at 42 CFR 410.38. The CMS regulation contains the details for the face-to-face examination, written order prior to delivery and the list of items subject to these requirements.

For an item to be covered by Medicare, a detailed written order (DWO) must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed DWO, the item will be denied as not reasonable and necessary.

Affordable Care Act 5-Element Order

For some items in this policy to be covered by Medicare, a written order is required to be in the supplier's file prior to delivery of the specified item(s). There are two differing order requirements that may apply depending upon the specific item prescribed:
The ACA 6407 specifies the five elements that must be contained in this written order. For purposes of this policy, this order is termed the 5-element order (5EO).

A written order prior to delivery (WOPD) that meets all of the requirements of a standard detailed written order (DWO).
If the supplier delivers an item addressed in this policy without first receiving the completed order, the item will be denied. Refer to the DOCUMENTATION REQUIREMENTS section of this LCD and/or to the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section of the related Policy Article for information about these prescription requirements and the type of denial that will result from non-compliance.

DEFINITIONS:

Apnea is defined as the cessation of airflow for at least 10 seconds.

Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds associated with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% decrease in oxygen saturation.

The apnea-hypopnea index (AHI) is defined as the average number of episodes of apnea and hypopnea per hour of sleep without the use of a positive airway pressure device. For purposes of this policy, respiratory effort related arousals (RERAs) are not included in the calculation of the AHI. Sleep time can only be measured in a Type I (facility based polysomnogram) or Type II sleep study (see descriptions below).

The respiratory disturbance index (RDI) is defined as the average number of apneas plus hypopneas per hour of recording without the use of a positive airway pressure device. For purposes of this policy, respiratory effort related arousals (RERAs) are not included in the calculation of the RDI. The RDI is reported in Type III, Type IV, and Other home sleep studies.

If the AHI or RDI is calculated based on less than 2 hours of sleep or recording time, the total number of recorded events used to calculate the AHI or RDI (respectively) must be at least the number of events that would have been required in a 2 hour period (i.e., must reach =30 events without symptoms or =10 events with symptoms).

INITIAL COVERAGE:

In this policy, the term PAP (positive airway pressure) device will refer to both a single-level continuous positive airway pressure device (E0601) and a bi-level respiratory assist device without back-up rate (E0470) when it is used in the treatment of obstructive sleep apnea.
An E0601 device is covered for the treatment of obstructive sleep apnea (OSA) if criteria A – C are met:

The beneficiary has a face-to-face clinical evaluation by the treating practitioner prior to the sleep test to assess the beneficiary for obstructive sleep apnea.

The beneficiary has a sleep test (as defined below) that meets either of the following criteria (1 or 2):

The apnea-hypopnea index (AHI) or Respiratory Disturbance Index (RDI) is greater than or equal to 15 events per hour with a minimum of 30 events; or,

The AHI or RDI is greater than or equal to 5 and less than or equal to 14 events per hour with a minimum of 10 events and documentation of:

Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,

Hypertension, ischemic heart disease, or history of stroke.

The beneficiary and/or their caregiver has received instruction from the supplier of the device in the proper use and care of the equipment.

If a claim for an E0601 is submitted and all of the criteria above have not been met, it will be denied as not reasonable and necessary.

An E0470 device is covered for those beneficiaries with OSA who meet criteria A-C above, in addition to criterion D:

An E0601 has been tried and proven ineffective based on a therapeutic trial conducted in either a facility or in a home setting.

Ineffective is defined as documented failure to meet therapeutic goals using an E0601 during the titration portion of a facility-based study or during home use despite optimal therapy (i.e., proper mask selection and fitting and appropriate pressure settings).

If E0470 is billed for a beneficiary with OSA and criteria A-D are not met, it will be denied as not reasonable and necessary.

A bi-level positive airway pressure device with back-up rate (E0471) is not reasonable and necessary if the primary diagnosis is OSA. If an E0471 is billed with a diagnosis of OSA, it will be denied as not reasonable and necessary.

If an E0601 device is tried and found ineffective during the initial facility-based titration or home trial, substitution of an E0470 does not require a new initial face-to-face clinical evaluation or a new sleep test.

If an E0601 device has been used for more than 3 months and the beneficiary is switched to an E0470, a new initial face-to-face clinical evaluation is required, but a new sleep test is not required. A new 3 month trial would begin for use of the E0470.

Coverage, coding and documentation requirements for the use of E0470 and E0471 for diagnoses other than OSA are addressed in the Respiratory Assist Devices (RAD) Local Coverage Determination (LCD) and related Policy Article (PA).

Sleep Tests

Coverage and Payment rules for sleep tests may be found in the LCDs for the applicable Medicare Part A or Part B contractor. There may be differences between those LCDs and the DME MAC LCD. For the purposes of coverage of PAP therapy, the DME MAC coverage, coding and payment rules take precedence.

Coverage of a PAP device for the treatment of OSA is limited to claims where the diagnosis of OSA is based upon a sleep test (Type I, II, III, IV, Other) that meets the Medicare coverage criteria in effect for the date of service of the claim for the PAP device. The sleep test must be either a polysomnogram performed in a facility-based laboratory (Type I study) or an inpatient hospital-based or home based sleep test (HST) (Types II, III, IV, Other). The test must be ordered by the beneficiary’s treating practitioner and conducted by an entity that qualifies as a Medicare provider of sleep tests and is in compliance with all applicable state regulatory requirements.

A Type I sleep test is the continuous and simultaneous monitoring and recording of various physiological and pathophysiological parameters of sleep with practitioner review, interpretation, and report. It is facility-based and must include sleep staging, which is defined to include a 1-4 lead electroencephalogram (EEG), electro-oculogram (EOG), submental electromyogram (EMG) and electrocardiogram (ECG). It must also include at least the following additional parameters of sleep: airflow, respiratory effort, and oxygen saturation by oximetry. It may be performed as either a whole night study for diagnosis only or as a split night study to diagnose and initially evaluate treatment.

An HST is performed unattended in the beneficiary’s home using a portable monitoring device. A portable monitoring device for conducting an HST must meet one of the following criteria:
Type II device – Monitors and records a minimum of seven (7) channels: EEG, EOG, EMG, ECG/heart rate, airflow, respiratory movement/effort and oxygen saturation; or,

Type III device – Monitors and records a minimum of four (4) channels: respiratory movement/effort, airflow, ECG/heart rate and oxygen saturation; or,

Type IV device – Monitors and records a minimum of three (3) channels, one of which is airflow; or,

Other - Devices that monitor and record a minimum of three (3) channels that include actigraphy, oximetry and peripheral arterial tone and for which there is substantive clinical evidence in the published peer-reviewed medical literature that demonstrates that the results accurately and reliably correspond to an AHI or RDI as defined above. This determination will be made on a device by device basis (See Appendix B for list of approved devices in this category).

For all PAP devices, beneficiaries who undergo an HST must, prior to having the test, receive instruction on how to properly apply a portable sleep monitoring device. This instruction must be provided by the entity conducting the HST and may not be performed by a DME supplier. Beneficiary instruction may be accomplished by either:

Face-to-face demonstration of the portable sleep monitoring device’s application and use; or,

Video or telephonic instruction, with 24 hour availability of qualified personnel to answer questions or troubleshoot issues with the device.

For all PAP devices the sleep test (Type I - IV, Other) must be interpreted by a practitioner who holds either:
Current certification in Sleep Medicine by the American Board of Sleep Medicine (ABSM); or,

Current subspecialty certification in Sleep Medicine by a member board of the American Board of Medical Specialties (ABMS) or American Osteopathic Association (AOA); or,

Completed residency or fellowship training by an ABMS or AOA member board and has completed all the requirements for subspecialty certification in sleep medicine except the examination itself and only until the time of reporting of the first examination for which the practitioner is eligible; or,

Active staff membership of a sleep center or laboratory accredited by the American Academy of Sleep Medicine (AASM), Accreditation Commission for Health Care (ACHC), or The Joint Commission (TJC, formerly the Joint Commission on Accreditation of Healthcare Organizations – JCAHO).

CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY:

Continued coverage of a PAP device (E0470 or E0601) beyond the first three months of therapy requires that, no sooner than the 31st day but no later than the 91st day after initiating therapy, the treating practitioner must conduct a clinical re-evaluation and document that the beneficiary is benefiting from PAP therapy.

For PAP devices with initial dates of service on or after November 1, 2008, documentation of clinical benefit is demonstrated by:

Face-to-face clinical re-evaluation by the treating practitioner with documentation that symptoms of obstructive sleep apnea are improved; and,

Objective evidence of adherence to use of the PAP device, reviewed by the treating practitioner.

Adherence to therapy is defined as use of PAP =4 hours per night on 70% of nights during a consecutive thirty (30) day period anytime during the first three (3) months of initial usage.

If the above criteria are not met, continued coverage of a PAP device and related accessories will be denied as not reasonable and necessary.

If the practitioner re-evaluation does not occur until after the 91st day but the evaluation demonstrates that the beneficiary is benefiting from PAP therapy as defined in criteria 1 and 2 above, continued coverage of the PAP device will commence with the date of that re-evaluation.

Beneficiaries who fail the initial 12 week trial are eligible to re-qualify for a PAP device but must have both:
Face-to-face clinical re-evaluation by the treating practitioner to determine the etiology of the failure to respond to PAP therapy; and,

Repeat sleep test in a facility-based setting (Type 1 study).This may be a repeat diagnostic, titration or split-night study.

If an E0601 device is tried and found ineffective during the initial facility-based titration or home trial, substitution of an E0470 does not change the length of the trial unless there is less than 30 days remaining in the trial period. If more than 30 days remain in the trial period, the clinical re-evaluation would still occur between the 31st and 91st day following the initiation of an E0601 and objective documentation of adherence on the E0470 would need to occur prior to the 91st day following initiation of the E0601. If less than 30 days remain in the trial period, the clinical re-evaluation and objective documentation of adherence must occur before the 120th day following the initiation of the E0601.

If an E0601 device was used for more than 3 months and the beneficiary was then switched to an E0470, the clinical re-evaluation must occur between the 31st and 91st day following the initiation of the E0470. There would also need to be documentation of adherence to therapy during the 3 month trial with the E0470.

If there is discontinuation of usage of a PAP device at any time, the supplier is expected to ascertain this and stop billing for the equipment and related accessories and supplies.

For a PAP device dispensed prior to November 1, 2008, if the initial Medicare coverage criteria in effect at the time were met and the criteria for coverage after the first 3 months that were in effect at the time were met, the device will continue to be covered for dates of service on or after November 1, 2008 as long as the beneficiary continues to use the device.

CONCURRENT USE OF OXYGEN WITH PAP THERAPY

Some beneficiaries may require the simultaneous use of home oxygen therapy with a PAP device. To be considered for simultaneous coverage, all requirements in the Coverage Indications, Limitations and/or Medical Necessity for both Oxygen and Oxygen Equipment and Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea LCDs must be met. Consequently, in addition to this LCD, suppliers should refer to the Oxygen and Oxygen Equipment LCD and related Policy Article for additional coverage, coding and documentation requirements.

Coverage of home oxygen therapy requires that the beneficiary be tested in the “chronic stable state.” Chronic stable state is a requirement of the National Coverage Determination (CMS Internet-only Manual, Pub. 100-03, Section 240.2) and is one of the key criteria when determining coverage of home oxygen therapy. The NCD defines chronic stable state as “…not during a period of an acute illness or an exacerbation of their underlying disease.” Based on this NCD definition, all co-existing diseases or conditions that can cause hypoxia must be treated and the beneficiary must be in a chronic stable state before oxygen therapy is considered eligible for payment. In addition, the beneficiary must have a severe lung disease, such as chronic obstructive pulmonary disease, diffuse interstitial lung disease, cystic fibrosis, bronchiectasis, widespread pulmonary neoplasm, or hypoxia-related symptoms or findings that might be expected to improve with oxygen therapy (see Oxygen LCD for additional information). For beneficiaries with OSA to be considered in the chronic, stable state, OSA must be sufficiently treated such that the underlying severe lung disease is unmasked. This must be demonstrated before oxygen saturation results are considered qualifying for oxygen therapy.

For beneficiaries with OSA, a qualifying oxygen saturation test for the purposes of determining Medicare home oxygen reimbursement may only occur during a titration polysomnographic study (either split-night or stand-alone). The titration PSG is one in which all of the following criteria are met:
The titration is conducted over a minimum of two (2) hours; and,
During titration:
The AHI/RDI is reduced to less than or equal to an average of ten (10) events per hour; or,
If the initial AHI/RDI was less than an average of ten (10) events per hour, the titration demonstrates further reduction in the AHI/RDI; and,
Nocturnal oximetry conducted for the purpose for oxygen reimbursement qualification may only be performed after optimal PAP settings have been determined and the beneficiary is using the PAP device at those settings; and,
The nocturnal oximetry conducted during the PSG demonstrates an oxygen saturation = 88% for 5 minutes total (which need not be continuous).

If all of the above criteria are met, for the purposes of a qualifying oxygen saturation test, the beneficiary is considered to be in the “chronic stable state.” To be eligible for Medicare coverage and payment for home oxygen therapy for concurrent use with PAP therapy, in addition to being in the chronic stable state, the beneficiary must meet all other coverage requirements for oxygen therapy.

Suppliers should refer to the Oxygen and Oxygen Equipment LCD and related Policy Article for additional coverage, coding and documentation requirements.

REPLACEMENT:

This section applies to PAP devices initially provided and covered while the beneficiary was in Medicare fee-for-service (FFS).

If a PAP device is replaced during the 5 year reasonable useful lifetime (RUL) because of loss, theft, or irreparable damage due to a specific incident, there is no requirement for a new clinical evaluation, sleep test, or trial period.

If a PAP device is replaced following the 5 year RUL, there must be a face-to-face evaluation by their treating practitioner that documents that the beneficiary continues to use and benefit from the PAP device. There is no requirement for a new sleep test or trial period.

BENEFICIARIES ENTERING MEDICARE:

For beneficiaries who received a PAP device prior to enrollment in fee for service (FFS) Medicare and are seeking Medicare coverage of either rental of the device, a replacement PAP device and/or accessories, both of the following coverage requirements must be met:
Sleep test – There must be documentation that the beneficiary had a sleep test, prior to FFS Medicare enrollment, that meets the Medicare AHI/RDI coverage criteria in effect at the time that the beneficiary seeks Medicare coverage of a replacement PAP device and/or accessories; and,

Clinical Evaluation – Following enrollment in FFS Medicare, the beneficiary must have a face-to-face evaluation by their treating practitioner who documents in the beneficiary’s medical record that:

The beneficiary has a diagnosis of obstructive sleep apnea; and,

The beneficiary continues to use the PAP device.
If either criteria 1 or 2 above are not met, the claim will be denied as not reasonable and necessary.

In these situations, there is no requirement for a clinical re-evaluation or for objective documentation of adherence to use of the device.

ACCESSORIES:

Accessories used with a PAP device are covered when the coverage criteria for the device are met. If the coverage criteria are not met, the accessories will be denied as not reasonable and necessary.

The following table represents the usual maximum amount of accessories expected to be reasonable and necessary:

A4604 1 per 3 months
A7027 1 per 3 months
A7028 2 per 1 month
A7029 2 per 1 month
A7030 1 per 3 months
A7031 1 per 1 month
A7032 2 per 1 month
A7033 2 per 1 month
A7034 1 per 3 months
A7035 1 per 6 months
A7036 1 per 6 months
A7037 1 per 3 months
A7038 2 per 1 month
A7039 1 per 6 months
A7046 1 per 6 months

Quantities of supplies greater than those described in the policy as the usual maximum amounts will be denied as not reasonable and necessary.

REFILL REQUIREMENTS

For DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products (A4604, A7027-A7046) that are supplied as refills to the original order, suppliers must contact the beneficiary prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the beneficiary. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are approaching exhaustion, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product. This is regardless of which delivery method is utilized. (CMS’ Program Integrity Manual, Internet-Only Manual, CMS Pub. 100-08, Chapter 5, Section 5.2.8).

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a beneficiary. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a beneficiary's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the prescribing practitioner that any changed or atypical utilization is warranted. Regardless of utilization, a supplier must not dispense more than a three (3) month quantity at a time.

Either a non-heated (E0561) or heated (E0562) humidifier is covered when ordered by the treating practitioner for use with a covered PAP (E0470 or E0601) device.





Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
N/A


Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

N/A

CPT/HCPCS Codes

Group 1 Paragraph: The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIERS:

EY - No physician or other licensed health care provider order for this item or service

GA - Waiver of liability statement issued as required by payer policy, individual case

GZ - Item or service expected to be denied as not reasonable and necessary

KX - Requirements specified in the medical policy have been met



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