Recent changes in the respiratory assist devices policy
could benefit ventilator providers.

Lisa K. Smith, JD

HME providers struggling to meet the Local Medical Review Policy continued coverage requirements for noninvasive positive pressure ventilator (NPPV) therapy patients got some relief on July 1. Respiratory assist devices (RAD) policy revisions that became effective on that date removed the requirement that a patient’s physician must see the patient between the 61st and 90th day after NPPV therapy is initiated for Medicare to continue coverage. In addition, the revisions eliminated the need to get the beneficiary statement completed within the month of that physician visit.

This is good news for providers, but there is more to the RAD policy revisions than just these two changes. Other RAD policy changes include:

• Adding specific polysomnogram criteria, such as an apnea/hypopnea index, for obstructive sleep apnea (OSA).

• Extending coverage and separate payment for heated humidifiers (Healthcare Common Procedure Coding System or HCPCS code K0531) when prescribed for use with a covered NPPV without backup rate (HCPCS code K0532).

• Adding HCPCS code K0534 for situations where a patient is using a RAD with a timed backup feature with an invasive interface, such as a tracheostomy tube.

What the Policy Says
In general, before Medicare will cover the cost of NPPV therapy, the RAD policy requires that the ventilator patient fall into one of four clinical disorder categories: restrictive thoracic disorder, severe chronic obstructive pulmonary disease (COPD), central sleep apnea (CSA), or OSA.

Furthermore, to receive Medicare coverage, the patient must meet certain requirements within each clinical disorder category. For example, a patient with a restrictive thoracic disorder qualifies for a RAD if he or she has a documented progressive neuromuscular disease or a severe thoracic cage abnormality, as well as qualifying arterial blood gas results, qualifying sleep oximetry results, or, for patients with progressive neuromuscular disease, a certain maximum level of inspiratory pressure or forced vital capacity.

Requirements for each of the other three categories— severe COPD, CSA, and OSA—are equally complicated, but can be understood by carefully studying the new RAD policy. It is posted on each of the Durable Medical Equipment Regional Carrier (DMERC) Web sites as the current RAD Local Medical Review Policy. Region B has one of the easiest to find and read. It is available online at www.cignamedicare.com/dmerc/lmrp/RAD.html.

Terminology Matters
All the clinical disorder requirements rely on clinical tests. This means it is critical that, when performing the qualifying tests, you ensure that the clinicians use the same definitions as the RAD policy does or else the tests will be invalid. For example, when measuring apnea and hypopnea, remember that the RAD policy defines apnea as the cessation of airflow for at least 10 seconds documented on a polysomnogram. Hypopnea is 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. Finally, the policy defines the apnea-hypopnea index as the average number of episodes of apnea and hypopnea per hour based on a minimum of 2 hours of sleep reported by polysomnography using actual recorded hours of sleep. That means that the apnea-hypopnea index may not be extrapolated or projected.

As you can see, it is still challenging to meet the RAD policy requirements, but in certain regards, qualifying patients is now easier. For example, other important rule changes that will simplify providing RADs include:

• The beneficiary no longer has to see the physician within the same month the beneficiary statement is completed.

• An office visit is not required for physician statement completion if the physician can otherwise ascertain the facts needed to do so, and those facts are accurately reflected in the progress notes of the patient’s medical chart.

• Neither the beneficiary nor the physician needs to complete and sign the statement by the 90th day. However, the supplier may not submit a claim(s) for the fourth or succeeding months’ services using the KX modifier (formerly the ZX modifier) unless both statements are completed, signed, and dated.

Only after the ventilator provider obtains both statements as described, even if either one is signed after the 90th day, may the provider submit claims for the fourth or subsequent month with a KX modifier. (If a beneficiary and physician attest to continued compliant use and benefit even later than the 90th day, it only serves as stronger evidence of the beneficiary’s commitment to continued use of the equipment and justification for Medicare’s continued reimbursement for it.)

Clarifying Modifier Use
The Region C DMERC provides a good example of this. According to Region C, if a patient began using a RAD on July 1 but the ventilator provider did not obtain a qualifying physician statement until October 15 and a qualifying beneficiary statement until November 20, then the KX modifier may still be added to the appropriate claim lines, but only if the claims for October 1 and November 1 (ie, the fourth and fifth months’ claims) are not submitted until on or after November 20 (ie, after the provider obtains both statements).

Ventilator providers should bear in mind, however, that simply getting the completed physician and beneficiary statements may not be sufficient evidence of medical necessity. It is critical that ventilator providers remind physicians to document in their medical records the patient’s progress and usage of the NPPV during the initial 3 months. In particular, the medical records for a patient must show that the patient is consistently using the NPPV for an average of 4 hours per 24-hour period and that the NPPV use benefits the patient.

Proceed With Caution
The RAD policy change has significantly eased the burden that ventilator providers previously had in obtaining the physician and beneficiary statements necessary for Medicare coverage beyond the first 3 months. But you must still be careful. Always pay close attention to qualifying requirements, but also take advantage of new opportunities to reduce the problems associated with providing NPPV.

Lisa K. Smith, JD, is an attorney with the Health Care Group of Brown & Fortunato, PC, Amarillo, Tex. She represents HME companies, pharmacies, and other health care providers and can be reached at (806) 345-6308 or lsmith@bf-law.com.