ATLANTA--Weeks after tabling the Sept. 1 implementation date for the local coverage determination for PAP devices, the DME MACs last week issued a revised LCD that eased at least some of the restrictions included in their first version of the medical policy.

The newly revised LCD was greeted with measured enthusiasm from industry stakeholders who noted, among other things, that it revises coverage criteria for documentation of the initial evaluation and also the requirement for beneficiary education by the entity conducting a home sleep test.

It also extends the implementation dates for credentialing of physicians interpreting the HSTs and facility-based polysomnograms and expands the dates during which patients must be re-evaluated for documenting benefits from PAP therapy.

“It’s a much softer, kinder version,” said Kelly Riley, director of the National Respiratory Network for The MED Group, Lubbock, Texas. “Home sleep testing is back in.”

But HME providers hoping for the green light to perform HSTs were disappointed.

“It does not open the door for providers to do [home] sleep testing,” said Andrea Stark, a Medicare consultant with MiraVista LLC in Columbia, S.C. “It specifically says providers cannot be involved.”

Indeed, as stated in the originally issued LCD, the ruling is clear: “No aspect of an HST, including but not limited to delivery and/or pickup of the device, may be performed by a DME supplier,” it reads.

Stark said she was slightly disappointed in that mandate. “I think it is an unnecessary restriction. DME providers are uniquely prepared to do that kind of [delivery and pickup],” she said. “The whole thing was about accessibility for the patient.”

The newly revised version is the result of controversy over the earlier LCD, published without public comment on July 17. Set for implementation on Sept. 1, it followed CMS’ national coverage determination issued in March.

Stakeholders, however, raised numerous issues about the LCD, saying that it restricted access, particularly in rural areas, and was released without the benefit of public comment even though it contained numerous new policy mandates. In August, the DME MACs elected to postpone its implementation.

“Implementation was delayed until contractors (such as Cigna Government Services) received official notification from the Centers for Medicare and Medicaid Services of the new national coverage determination and instructions on what changes to implement,” explained Robert Hoover, M.D., medical director for Jurisdiction C. “Although a formal comment process was not required, the DME MAC medical directors received feedback from the provider community and delayed the implementation of certain provisions pending further review.”

Stark said even though the newly revised version also was not held up for public comment, “I think the changes are going to be livable for most providers.”

Walt Gorski, vice president of government affairs for the American Association for Homecare, which had questioned the absence of a public comment period, said the association was in the process of reviewing the new LCD to determine how suppliers can move forward under its terms.

Meanwhile, stakeholders applauded other provisions of the revised policy.

For example, providers can now document compliance either by “direct download from equipment or by visual inspection of adherence information,” the LCD says.

“The biggest thing that jumped out at me is that we can do a visual compliance reading to determine if the patient is really in compliance. That’s definitely a good thing,” said provider Patrick Clevidence, vice president of respiratory services for Medical Services Company in Cleveland, Ohio.

According to the LCD: “Documentation of adherence to PAP therapy shall be accomplished through direct download or visual inspection of usage data with documentation provided in a written report format to be reviewed by the treating physician and included in the beneficiary’s medical record. This information does not have to be submitted with the claim but must be available upon request.”

“You can actually get information from the hour meter; you don’t have to have a download. Before, you were actually going to have to buy the more expensive CPAP model, which, in some cases, can be $200 to $250 more,” Clevidence said. “Now, we won’t have to inconvenience the patient by having them send in their Smart card, have someone here download it, print out the information and send it out to the physician’s office.”

Riley added that “a huge burden was taken off the provider,” noting that with the previous LCD, “there was a huge number of providers that really knew their costs that said, ‘We simply cannot accept assignment from beneficiaries.’ I’m not going to say this is totally going to go away, but this is a warmer, kinder version.”

In addition, the newly revised LCD relaxes the requirements for educating the beneficiary about HST.

“Patient instruction may be accomplished by 1) face-to-face demonstration of the portable sleep monitoring device’s application and use; or 2) video or telephone instruction, with 24-hour availability of qualified personnel to answer questions or troubleshoot issues with the device,” the LCD says.

But it also stipulates, “This instruction must be provided by the entity conducting the HST and may not be performed by the DME supplier.”

Stark noted that the new LCD also stretches out the time period for patients who must switch PAP devices in midstream. “If they switch on day 90, they have until day 120 to prove compliance and adherence,” she said.

As well, she noted, the LCD puts in place requirements for physician education.

Effective Nov. 1, 2008, all HSTs must be interpreted by a physician who meets one of the following four criteria:

1. Current certification in sleep medicine by the American Board of Sleep Medicine;

2. Current subspecialty certification in sleep medicine by a member board of the American Board of Medical Specialties; or

3. Completed residency or fellowship training by an ABMS 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 physician is eligible; or

4. Active staff membership of a sleep center or laboratory accredited by the American Academy of Sleep Medicine or the Joint Commission.

Physicians interpreting facility-based sleep tests must meet one of those four criteria by Jan. 1, 2010, according to the new LCD.

HME providers, Stark advised, should ensure that the “the individuals you are getting these results from have their credentials in place in order for you to be covered.”

The LCD also has established an ICD-9 code of 327.23 as the specific code for obstructive sleep apnea.

“They are not allowing for any other derivatives of sleep apnea or non-specific codes,” Stark said. “So this will be a big issue.”

According to NHIC, the DME MAC for Jurisdiction A, “ICD-9 code 327.23 should be used on all claims at this time for patients with obstructive sleep apnea.”

AAHomecare will hold a teleconference, "CPAP Versus PAP Coverage: Where It Is and Where It Is Going," with Stark as the featured speaker tomorrow from 2 to 3:30 p.m. ET. For information, visit www.aahomecare.org.

Stark will also hold a teleconference on the new LCD, “Breathe Easier Knowing CPAP and RAD Regulations,” from 2 to 3 p.m. ET on Oct. 21. For more information, contact michelle@miravistallc.com.

In addition to the LCD for PAP devices, the DME MACs also revised the LCDs for lower limb prosthesis and wheelchair options and accessories, and are proposing new policies for heating pads and heat lamps, oral appliances for obstructive sleep apnea and transcutaneous electrical joint stimulation devices.

For FAQs on the PAP LCD, a summary of its revisions and the additional policy proposals, click here for the NHIC Web site.