Or. Admin. Code § 410-122-0202

Current through Register Vol. 63, No. 11, November 1, 2024

Section 410-122-0202 - Positive Airway Pressure (PAP) Devices for Adult Obstructive Sleep Apnea

(1) The Division may cover a positive airway pressure (PAP) device for treatment of obstructive sleep apnea (OSA) when:

(a) The client has a face-to-face clinical evaluation by the treating practitioner prior to a sleep test to assess the client for obstructive sleep apnea; and

(b) The client has a polysomnogram performed in a facility-based laboratory or a home sleep test that demonstrates positive diagnosis of OSA with either of the following:

(A) The apnea-hypopnea index (AHI) or Respiratory Disturbance Index (RDI) is greater than or equal to 15 events per hour; or

(B) The AHI or RDI is between 5 and 14 events with additional symptoms including one or more of the following:

(i) Excessive daytime sleepiness as documented by a score of greater than 10 on the Epworth Sleepiness Scale or daytime sleepiness interfering with ADLs that is not attributable to another modifiable sedating condition (e.g. narcotic dependence); or

(ii) Documented hypertension; or

(iii) Ischemic heart disease; or

(iv) History of stroke.

(c) The client or their caregiver has received instruction from the supplier of the PAP device and accessories in the proper use and care of the equipment.

(d) The client meets criteria listed in section (2) of this rule for the particular device to be used.

(2) Continuous Positive Airway Pressure (CPAP) or Auto-titrating Continuous Positive Airway Pressure (APAP) devices:

(a) A CPAP/APAP device (E0601) may be covered for clients with OSA when criteria in (1)(a)-(c) are met;

(b) A three-month trial (rental) period for PAP devices is required to determine benefit and ongoing coverage of the device;

(c) Rental charges apply toward purchase.

(3) Respiratory Assist devices:

(a) A respiratory assist device (RAD) without backup rate (E0470) may be covered for clients with OSA when:

(A) Criteria in (1)(a)-(c) of this rule are met, and

(B) A CPAP/APAP device (E0601) has been tried and proven ineffective. Ineffective use is defined as documented failure to meet therapeutic goals using a CPAP/APAP device during the titration period of a facility-based study or during home use despite optimal therapy (i.e., proper mask selection and fitting and appropriate pressure settings);

(b) If a CPAP/APAP device is tried and found ineffective during the initial facility-based titration or three-month home trial, substitution of a RAD does not require a new face-to-face clinical evaluation or sleep test;

(c) If a CPAP/APAP device has been used for more than three months and the client is switched to a RAD, a clinical re-evaluation must occur, but a new sleep test is not required. A new three-month trial would begin for use of the RAD;

(d) Coverage, coding, and documentation requirements for the use of RADs for diagnoses other than OSA are addressed in 410-122-0205 Respiratory Assist Devices.

(e) A RAD with backup rate (E0471) is not medically indicated for the treatment of obstructive sleep apnea.

(4) For a client using a PAP device prior to Oregon Health Plan (OHP) enrollment, continuing coverage for the device and related accessories may be authorized on a case-by-case basis by the appropriate authorizing unit.

(5) Continued Coverage of PAP device:

(a) Ongoing rental of a PAP device (E0470 or E0601) beyond the three-month trial period is an option in lieu of purchase when medically appropriate, cost effective, and conditions of coverage have been met;

(b) 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 shall conduct a face-to-face clinical re-evaluation and document that the client is benefiting from PAP therapy;

(c) If the clinical re-evaluation does not occur until after the 91st day but the evaluation demonstrates that the client is benefiting from PAP therapy as defined in criteria, continued coverage of the PAP device will commence with the date of that re-evaluation;

(d) If a CPAP/APAP has been used more than three months and the client is switched to a RAD, then the clinical re-evaluation shall occur between the 31st and 91st day following initiation of the RAD;

(e) Clients who fail the 3-month trial may be eligible to re-qualify for a PAP device but must have both:

(i) Face-to-face clinical re-evaluation by the treating practitioner to determine etiology of the failure to respond to PAP therapy; and

(ii) Repeat sleep test in a facility-based setting if deemed necessary by the treating practitioner. This may be a repeat diagnostic titration or split-night study.

(6) Accessories:

(a) Accessories used with a PAP device are covered when the coverage criteria for the device are met;

(b) Accessories are separately reimbursable at the time of initial issue and when replaced;

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

(d) The following represents the usual maximum number of accessories expected to be medically appropriate:

(A) A4604 - 1 per 3 months;

(B) A7027 - 1 per 3 months;

(C) A7028 - 2 per month;

(D) A7029 - 2 per month;

(E) A7030 - 1 per 3 months;

(F) A7031 - 1 per month;

(G) A7032 - 2 per month;

(H) A7033 - 2 per month;

(I) A7034 - 1 per 3 months;

(J) A7035 - 1 per 6 months;

(K) A7036 - 1 per 6 months;

(L) A7037 - 1 per 3 months;

(M) A7038 - 2 per month;

(N) A7039 - 1 per 6 months;

(O) A7046 - 1 per 6 months.

(7) Payment Authorization:

(a) From the initial date of service through the second date of service, prior authorization (PA) is not required for PAP device rental and related accessories. The provider is responsible to ensure all rule requirements are met;

(b) Payment authorization (i.e., a payment authorization number for billing) is required prior to submitting claims and will be given once all required documentation has been received and any other applicable rule requirements have been met;

(c) Payment authorization is obtained from the same authorizing authority as specified in 410-122-0040;

(d) All subsequent services starting with the third date of service require PA;

(e) An order refill does not have to be approved by the ordering practitioner. However, a client or their caregiver must request specific ongoing PAP supplies and accessories, subject to rule limitations and requirements, before they are dispensed. The DMEPOS provider shall not automatically dispense a quantity of supplies and accessories on a predetermined regular basis, even if the client has "authorized" this in advance;

(f) It is the provider's responsibility to monitor appropriate and effective use of the device as ordered by the treating practitioner. When the equipment is not being used as prescribed, the provider shall stop billing for the equipment and related accessories and supplies.

(8) Guidelines:

(a) Polysomnography is the continuous and simultaneous monitoring and recording of various physiological and pathophysiological parameters of sleep with practitioner review, interpretation, and report. It shall include sleep staging, which is defined to include a 1-4 lead electroencephalogram (EEG), electro-oculogram (EOG), submental electromyogram (EMG) and an electrocardiogram (ECG). It shall 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;

(b) Polysomnographic and home studies shall be ordered by the client's treating practitioner, conducted by an entity that qualifies as a Medicare provider of sleep tests, and in compliance with all applicable state regulatory requirements;

(c) Polysomnographic studies and home sleep tests shall be scored according to the recommended rules as described in the American Academy of Sleep Medicine (AASM) Manual for Scoring of Sleep and Associated Events;

(d) Polysomnographic studies may not be performed by a DMEPOS provider;

(e) Home sleep tests are performed unattended in the client's home using a portable monitoring device that meets the following criteria:

(A) 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

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

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

(D) Other - Devices that monitor and record a minimum of three (3) channels that include actigraphy, oximetry, and peripheral arterial tone;

(f) For all PAP devices, clients who undergo a home sleep study shall, prior to having the test, receive instruction on how to properly apply a portable sleep monitoring device. This instruction shall be provided by the entity conducting the home sleep test and may not be performed by a DME supplier.

(g) No aspect of a home sleep test, including but not limited to delivery and/or pickup of the device, may be performed by the DME supplier.

(h) Apnea is defined as the cessation of airflow for at least 10 seconds and documented on a polysomnogram or home sleep monitoring equipment;

(i) Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds with at least a 30 percent reduction in thoracoabdominal movement or airflow as compared to baseline and with at least a 4 percent decrease in oxygen saturation;

(j) 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. Respiratory effort related arousals (RERAs) are not included in the calculation of the AHI;

(k) 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. Respiratory effort related arousals (RERAs) are not included in the calculation of the RDI;

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

(m) Adherence to therapy is defined as use of PAP four hours or more per night on 70 percent of nights during a consecutive thirty-day period anytime during the first three months of initial usage.

(9) Documentation Requirements:

(a) Initial coverage:

(A) For CPAP/APAP device, submit the facility-based polysomnogram report or home sleep study report that supports a diagnosis of OSA prior to the third date of service;

(B) For a RAD, submit specific documentation from the treating practitioner that a CPAP was tried and shown to be ineffective;

(b) For extended rental use or purchase of a PAP device beyond the first three months of initial therapy, submit the following documentation no sooner than the 61st day after initiating therapy and prior to the fourth date of service:

(A) Documentation of the face-to-face clinical re-evaluation by the treating practitioner that supports clinical benefit including client tolerance, compliance and efficacy, and demonstrates symptoms of OSA are improved; and

(B) Objective evidence of adherence to use of the PAP device, including a summary of PAP compliance report through a direct download of usage date; or

(C) When objective data does not support compliance and efficacy, a face-to-face visit with the treating practitioner clearly specifying a treatment plan with measurable goals to improve adherence to treatment; and

(D) Any other medical documentation that supports indications of coverage;

(E) If a CPAP/APAP device has been used more than three months and the client is switched to a RAD, documentation of adherence to therapy shall be submitted during the three-month trial with the RAD;

(c) For a client using a PAP device prior to OHP enrollment, submit the following:

(A) Documentation of clinical benefit including client tolerance, compliance and efficacy, and that symptoms of OSA are improved from the client's treating practitioner; and

(B) A facility-based polysomnogram report or home sleep test as described in this rule and scored as described in (1)(b) that supports a diagnosis of OSA, if available.

(10) Table 122-0202 - PAP Devices.

Or. Admin. Code § 410-122-0202

OMAP 37-2000, f. 9-29-00, cert. ef. 10-1-00; OMAP 32-2001, f. 9-24-01, cert. ef. 10-1-01; OMAP 8-2002, f. & cert. ef. 4-1-02; OMAP 21-2003, f. 3-26-03, cert. ef. 4-1-03; OMAP 44-2004, f. & cert. ef. 7-1-04; OMAP 46-2004, f. 7-22-04 cert. ef. 8-1-04; OMAP 76-2004, f. 9-30-04, cert. ef. 10-1-04; OMAP 94-2004, f. 12-30-04, cert. ef. 1-1-05; OMAP 11-2005, f. 3-9-05, cert. ef. 4-1-05; OMAP 44-2005, f. 9-9-05, cert. ef. 10-1-05; OMAP 35-2006, f. 9-15-06, cert. ef. 10-1-06; OMAP 47-2006, f. 12-15-06, cert. ef. 1-1-07; DMAP 15-2007, f. 12-5-07, cert. ef. 1-1-08; DMAP 17-2008, f. 6-13-08, cert. ef. 7-1-08; DMAP 44-2008(Temp), f. 12-17-08, cert. ef. 1-1-09 thru 6-15-09; DMAP 11-2009, f. & cert. ef. 6-1-09; DMAP 13-2010, f. 6-10-10, cert. ef. 7-1-10; DMAP 81-2014, f. 12-23-14, cert. ef. 1/1/2015; DMAP 101-2023, amend filed 12/29/2023, effective 1/1/2024; DMAP 2-2024, minor correction filed 01/04/2024, effective 1/4/2024

Tables referenced are available from the agency.

To view attachments referenced in rule text, click here to view rule.

Statutory/Other Authority: ORS 414.065

Statutes/Other Implemented: ORS 414.065