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Headline News
It's a Go for Home-Based Sleep Testing
BALTIMORE--Late Friday, the Medicare Evidence Development and Coverage Advisory Committee recommended changes to CMS' national coverage determination on coverage of continuous positive airway pressure therapy for obstructive sleep apnea. The proposed decision memorandum addressed several issues, including the controversial topic of home-based testing for OSA--and it got the go.

Under current policy, OSA patients must be diagnosed through a sleep lab test in order for Medicare to cover the cost of CPAP therapy. But a request from the American Academy of Otolaryngology-Head and Neck Surgery asking the agency to accept in-home testing prompted CMS to open its policy for review earlier this year. (See HomeCare Monday, July 9.)

CMS said it received 680 comments on the request, with 388 (57 percent) of the commenters supporting expansion of coverage to include the use of home sleep testing, while 292 (43 percent) disagreed.

In the memo, MedCAC recommended:

--Coverage of CPAP be initially limited to a 12-week period to identify beneficiaries diagnosed with OSA with subsequent coverage for those who benefit from the therapy;
--Coverage of CPAP when diagnosis involves using a clinical evaluation and polysomnography performed in a sleep lab;
--Expansion of CPAP coverage to those diagnosed through a combination of a clinical evaluation and unattended home sleep testing using a Type II, III or IV device;
--Modification of the criteria for a positive sleep study "to remove the requirement for a minimum two hours of continuous recorded sleep and to recognize shorter periods of continuous recorded sleep if the total number of recorded events during that shorter period is at least the number of events that would have been required in a two-hour period;" and
--Deleting the current distinct requirements that an individual have moderate to severe OSA and that surgery is a likely alternative.

Additionally, citing a lack of sufficient evidence that clinical diagnosis alone or clinical diagnosis in combination with devices other than Type I, II, III, or IV adequately identifies beneficiaries with OSA that will benefit from CPAP, the committee proposed expansion of Medicare coverage for CPAP in such instances only when provided in the context of a clinical study.

Contacted on Saturday, Robert D. Hoover, Jr., MD, MPH, FACP, chief medical officer for DeVilbiss Healthcare, Somerset, Pa., said the outcome of the memo "closely tracks" the voting of the MedCAC panel after a Sept. 12 meeting on the issues. But some points need further clarification, he said.

"Interestingly, while they provide coverage for the initial 12 weeks, there is no mention of what documentation is required for continuing therapy past that point. I assume that it will be up to the DME medical directors to outline those requirements," he said.

Hoover was also surprised that CMS afforded coverage to Type IV devices and did not address home titration. "Type IV devices have the fewest number of monitoring channels and also the lowest diagnostic 'precision' in the medical literature," he said. "Also, the decision does not address home titration, which is essential to a diagnostic strategy that attempts to avoid the high cost of a facility-based study. Since the decision is published as a draft with comments, I suspect physicians and providers will seek clarification on this issue."

According to the memo, "No single tool reliably identifies all beneficiaries who will benefit from a CPAP device while excluding those who will not. Thus, we believe that the perfect tool for diagnosing OSA in all Medicare beneficiaries is not [polysomnography, home sleep testing] or trial by CPAP. We believe that different beneficiaries will benefit from different strategies. The preferred strategy in a given individual will likely vary with the severity of the patient's symptoms, local access to a sleep laboratory, and the need to rule out other conditions that may cause symptoms similar to OSA, for example nocturnal seizures or narcolepsy."

Devices that do not fit into the Type II, III or IV category got a nod as well.

"CMS has left the door open for coverage of other home diagnostic systems that don't fit neatly into a Type II, III or IV category. Coverage of those technologies through clinical studies will add to the body of evidence for those devices and potentially gain them formal coverage in the future," Hoover said.

CMS' final decision is due in March of 2008.

To view the proposed decision memo in full or to submit comments, click here.

An audio recording of the call will be posted to the Special Open Door Forum Web site at www.cms.hhs.gov/OpenDoorForums/05_ODF_SpecialODF.asp and will be accessible for downloading beginning Dec. 27.

House Subcommittee Appeals to SBA for Competitive Bidding Delay
WASHINGTON--The House of Representatives Committee on Small Business, Subcommittee on Investigations and Oversight, sent a letter to the U.S. Small Business Administration Wednesday to use its muscle with CMS and intervene to delay competitive bidding.

The letter, from Reps. Jason Altmire, D-Pa., and Louie Gohmert, R-Texas, asked that implementation of the rule be halted until the SBA's Office of Advocacy can assess its economic impact on small businesses. The two are chairman and ranking member of the House subcommittee.

"The DMEPOS industry is overwhelmingly a network of small- to medium-sized businesses serving relatively small service areas," the congressmen wrote. "In fact, CMS estimates that approximately 85 percent of registered DMEPOS suppliers are considered small, according to the SBA definition.

"In its final rule, CMS states that the DMEPOS supplier industry is expected to be significantly impacted by this final rule. It is imperative that Advocacy conduct a timely review of the available facts, including a comprehensive economic analysis, in advance of any final implementation of the CMS DME competitive bidding rule. A rushed or flawed implementation process has the potential to severely if not irreparably damage thousands of small businesses."

The letter noted that at a recent subcommittee hearing, "the small business community raised legitimate concerns that they will not be able to compete with large, national firms in the bidding process, thus threatening local jobs and patient access to care."

Given the magnitude of the program, set to be implemented in 10 MSAs in July 2008, Altmire and Gohmert said they were concerned that "CMS anticipated roughly 15,000 suppliers would participate in the initial bidding process, yet only 2,200 were in a position to even submit bids. Once the competitive bidding program has taken full effect, as few as 20 suppliers on average will be initial bid 'winners' in each MSA, putting small suppliers at a tremendous disadvantage."

The letter was sparked by the subcommittee's Oct. 31 hearing on the issue, which drew strong testimony from a string of HME advocates. Representing the American Association for Homecare, provider Georgie Blackburn of Blackburn's, Tarentum, Pa., charged that "since Medicare payments typically comprise 35 to 50 percent of a small provider's revenue, losing the ability to provide competitively bid items for a three-year contract period is essentially a death knell."

For more on the subcommittee hearing, see HomeCare Monday, Nov. 5.

To read the Altmire/Gohmert letter in full, click here.

Fate of Last-Minute Cuts to HME Uncertain
WASHINGTON--Unable to settle on a Medicare package last week, the House of Representatives threw up its hands, tossing the hot potato to the Senate. The move could ultimately benefit HME providers, some Washington insiders said.

"What's promising is that the House has punted [the Medicare reform package] over to the Senate and said, 'You put it to together,'" said John Gallagher, vice president of government relations for Waterloo, Iowa-based VGM, noting that a Senate version of the legislation "would be more beneficial to the industry than what would be coming out of the House."

Whether the Senate can beat out a package that will be approved by both parties in Congress before legislators adjourn on Friday for the rest of the year--and whether it can craft one the president will sign--is uncertain. Senate Finance Committee Chairman Max Baucus, D-Mont., said last week it was possible that Medicare legislation "may be pushed off until next year."

Cara Bachenheimer, senior vice president, government relations, for Elyria, Ohio-based Invacare, said Friday "the fate of a Medicare package this year remains highly questionable."

But what happens is of crucial import to the HME industry.

For months, Congress has attempted to come up with a Medicare reform package including reauthorization and expansion of the State Children's Health Insurance Program. Under a "pay as you go" mandate, legislators also have been frantically searching for funds to avert a 10 percent reduction in physician fees set for Jan. 1. Among the suggested ways to pay for the so-called "doc fix": home oxygen and power wheelchair reimbursement cuts.

While President Bush vetoed the latest version of the SCHIP reauthorization bill on Wednesday, the threat to HME remains, Bachenheimer said.

"No question, oxygen and power wheelchair provisions are on the table, at risk," she said.

The House measure calls for the current oxygen rental cap to be reduced from 36 to 18 months (new technology would be exempt) and elimination of the first-month purchase option for power wheelchairs.

The Senate version is rumored to ditch the oxygen cap reduction and instead propose a reimbursement cut of anywhere from $30 to $70 for stationary oxygen concentrators (new technology would not be included in the cut). It would eliminate the first-month purchase option for power wheelchairs but would carve out complex rehab.

"In short, we now have a Medicare package from the House and an 'informal' Medicare package from the Senate," Bachenheimer said in an update from Washington. "The Senate package has not been publicized, has not been subject to Finance Committee approval, nor has it passed the Senate. These are unusual dynamics, making the House-Senate negotiation process fairly secret." She added that those negotiations could run through the weekend and into the early part of this week.

Bachenheimer also said that because of the brief period Congress has left before its Christmas recess, "the Medicare bill must be attached to a legislative vehicle that is a 'must-pass' piece of legislation or it is unlikely to move this calendar year."

Bachenheimer said the bill could be a part of a "small, one year or less, 'doc-fix' bill ... A six-month doc-fix bill is possible, punting the issue to next year's Congress to resolve."

Another stumbling block is the threat of a presidential veto. Earlier this month, President Bush told lawmakers he would veto any Medicare package employing managed care cuts or drug benefit cuts. Both the House and the Senate packages rely on cuts to managed-care programs as a means to finance their plans, Bachenheimer said.

"Therefore, even if the Congress passes a Medicare bill, it remains to be seen whether President Bush will veto it," she said.

Because nothing is yet set in concrete, both Bachenheimer and Gallagher stressed now is the time for HME providers to lobby legislators for no cuts to oxygen or power wheelchair reimbursement.

"We have got to get people fired up, on the phone with members of Congress and particularly members of the Senate," Gallagher said.

"We are working very diligently with our Senate allies to get oxygen and power wheelchairs off the list, or at least get the oxygen payment reduction decreased significantly," Bachenheimer said. "If the Medicare package doesn't happen before Congress recesses, it will come back early in 2008, and our fight will continue to ward off these proposed cuts."

K0823 Claims Review to Continue, TriCenturion Says
COLUMBIA, S.C.--On Friday, TriCenturion released the first-quarter results of its prepayment review of K0823 power wheelchairs and said the review will continue.

In September, the Jurisdiction A/B DME Program Safeguard Contractor said a prepayment probe showed sky-high denial rates of 87.51 percent for Jurisdiction A and 93.36 percent for Jurisdiction B. (See HomeCare Monday, Sept. 24.)

For the first quarter of the review, the Charge Denial Rate was 89.75 percent for Jurisdiction A and 88.73 percent for Jurisdiction B, the DME PSC said.

TriCenturion noted the majority of the claims were denied because policy criteria weren't met or because no medical records were submitted for review.

The following were listed as the major reasons for denial:

--The physician order did not have all of the required seven elements.
--It was not documented that a reason for the physician visit was for a mobility examination.
--Functional limitations were not addressed in the face-to-face evaluation.
--Letters of attestation were submitted without supporting information from the medical record.
--Supplier-created mobility evaluation forms were submitted as a substitution for information from the medical record.
--There was no date stamp or equivalent to verify supplier receipt of the physician order within 45 days.

TriCenturion said the prepayment review will continue.

Providers Unhappy with NBC Segment on Medicare Fraud
MIAMI--Just weeks after scathing reports on the home medical equipment industry by National Public Radio and the New York Times, HME took another body blow last week, this time delivered in a two-part series that aired on NBC.

"I felt like I'd been kicked in the stomach," said Heather Allan, executive director of the Florida Association of Medical Equipment Services, after watching the segments that aired Monday, Dec. 10, and Tuesday, Dec. 11, on "NBC Nightly News with Brian Williams."

Like the earlier reports, the NBC series by correspondent Mark Potter focused on fraudulent Medicare billing in HME, particularly in South Florida. After both previous stories, industry stakeholders had pinned their hopes for a fair report on NBC. But the TV series made only swift mention of legitimate providers and did not include any of the three hours of discussion Potter had with FAMES President Raul Lopez, director of operations for Bayshore Dura Medical in Miami Lakes.

"I was deeply, deeply disappointed," Allan said, noting that her overall impression from the NBC piece was that "every single person in this industry is a crook."

She added: "I don't know that the story was ever intended to be an unbiased and balanced look. I didn't get the impression that it was after reviewing both segments."

In a letter to Williams, Elizabeth M. Moran, executive director of the Medical Equipment Suppliers Association, which is based in Casselberry, Fla., and covers Arkansas, Louisiana, New Mexico and Texas, objected to the piece, saying it was "sensationalistic and focused only on the negative."

"To paint all DME providers with the same brush as those with false store fronts, or crooked pharmacies, or dishonest doctors, did an entire industry a grave injustice," she wrote. Moran asked for an apology--or even better, she said--"an objective look at the industry and its good works."

While the NBC segments themselves did not contain the flip side of fraudulent DME, visitors to the NBC Web site could dig around and find more material. For example, Lopez could be seen in a brief video, and Potter, in a piece written for the site, does distinguish between legitimate HME companies and crooks.

"Unlike real DME companies, which have showrooms, warehouses, public offices, trained staff and professional record-keeping, the fraudulent companies are usually shell companies with shadowy business practices, hidden owners and tiny, locked offices which are only there to create the illusion of legitimacy," he wrote. "They rarely have any medical products for actual sale or delivery."

While the NBC series disappointed many in the industry, it and the other pieces may not be as damaging as some had feared, said John Gallagher, vice president of government relations for Waterloo, Iowa-based VGM. Even though they come at a critical time--just as Congress is considering additional cuts to oxygen and power wheelchair reimbursement--they might not carry much weight.

"The reports don't help," Gallagher acknowledged. "But the timing is such that most members of Congress see right through it."

Florida Companies under Medicaid Microscope
TAMPA-ST. PETERSBURG, Fla.--On the heels of Medicare's supplier fraud demonstration in South Florida's Miami-Dade, Palm Beach and Broward counties, HME companies in the state's Tampa-St. Petersburg area are coming under the Medicaid microscope.

Weekend reports in the St. Petersburg Times and The Tampa Tribune detailed an investigation by the state's Agency for Health Care Administration and the Florida Attorney General's office centering on Medicaid oxygen concentrator reimbursements at eight companies in Hillsborough and Pinellas counties.

According to the Times story, preliminary findings by a 12-member team of investigators during visits that included document reviews and customer interviews found instances of "billing for equipment that was never delivered, unlicensed installers and inadequately serviced equipment." Those findings will be referred to the attorney general's Medicaid Fraud Control Unit, the Department of Health and possibly to Medicare, the Times article said.

The newspapers listed companies that were visited by the investigators as ASAP Home Oxygen in St. Petersburg; BayCare Home Care in Largo; CareMed Respiratory Services in Tampa; the Brandon, Plant City and St. Petersburg locations of Clearwater-based Lincare Holdings; Matrix Medical in Plant City; Mercury Enterprises in Clearwater; Respitek in Tampa; and Rotech Oxygen and Medical Equipment in Tampa.

An AHCA spokesman told the Tribune "this does not mean those entities will find cause to sanction any of those providers."

The Times reported officials with some companies that had been visited were surprised by the outcome. "They told me everything looked okay," Robert Arado of CareMed Respiratory Services told the Times.

Neither Snow nor Rain nor Gloom of Night Will Keep HME Providers from Their Appointed Rounds
ARLINGTON, Va.--After a deadly storm that coated much of the Plains region in ice last week, the American Association for Homecare, the Midwest Association for Medical Equipment Services and VGM Group praised the efforts of HME providers to care for their patients.

At the height of the storm, more than a million customers in Oklahoma, Kansas and Missouri were without power, according to news reports, and more than 280,000 homes and businesses were still in the dark as of Friday.

In several states, seniors on home oxygen were taken to warming centers or shelters because of the power outages, AAHomecare said. "But in all states, home oxygen providers had prepared for the storm and responded with extra visits and contacts with patients."

In its Wednesday newsletter, the association reported the following first-hand accounts:

--Tim Moore, a regional manager at Wilkinson Home Care Equipment in Nevada, Mo., noted that in two of the communities they serve, more than half the population was without power. "We have filled and delivered well over 100 tanks in the last three days to keep our current patients, nursing homes and some of our competitors (who had no power, but had customers in need) in a constant supply of oxygen. We have made daily runs 65 miles south to Joplin [Missouri] to ensure that our store there had enough tanks to handle the needs that might arise.

"We have made these runs regardless of weather and what might happen, because these are our customers. Just because the roads are bad, or the power is out, we still have an obligation as providers. I drove to Joplin on Sunday and delivered about 30 tanks to a nursing home without power, and to our own store. We have employees without power in their own homes, who are working to meet the [patient's] needs. We had one store without power for about 48 hours, but we had the manager stationed there in case customers came by to get tanks or supplies. These are the things that make this industry different from so many other health care entities."

--Maria J Lucas is CEO of Asthma & Respiratory Services of Oklahoma, which covers most of northeast Oklahoma and into the Oklahoma City and Enid areas. The company takes care of ventilator patients as well as oxygen patients. "I have to say our team has done a remarkable job of planning for this storm. We were hit last year with several major ice storms and we learned from that experience! We started midweek last week contacting our patients and making sure they were stocked up before the storm hit.... We have a break now in between storms, and we are again rushing to get our people covered for the next storm that is moving in on Friday. We do ground our fleet when the weather is at its worst as we do not want to have our employees in danger, but we are out again just as soon as possible."

--Family Medical Equipment in Altus, Okla., has oxygen customers in the southwest part of the state. According to the company's Josh Drake: "We used the time available prior to the storm to contact each customer who may be affected. We spent many extra hours in service calls and mileage, above our budget, to deliver extra oxygen to each patient in our service area." While Family Medical will not receive any extra reimbursements for its efforts, they note with satisfaction that, "not a single customer had a shortage of oxygen while electricity was off."

--In Hampton, Iowa, Long Term Medical Supply has seven locations serving home patients and nursing facilities, three of which were severely affected by the storms that hit Southern Iowa earlier this week. Mari Banse of the company's corporate office described one phone conversation from the week: "When I received a call from one of our store managers down in Osceola, Iowa, today sharing his feelings and stories with me about the amazing effort he was putting into his job, it almost brought me to tears.

"In the earlier hours of the morning this man started out in the pitch black, eerie town that got around three inches of rain turning into ice that took out all of the power and was taking down trees. Concerned about the safety of his patients, he began to travel from home to home to ensure that they were safe and not afraid of their lack of power and inability to get to a safe place. He shuttled people to shelters that were set up at the local hospital and casino, even going above and beyond his job description he took hot meals and blankets to elderly patients. This was an area that some streets were not even passable due to downed trees. When he couldn't get down roads he made sure that he got in contact with them somehow to make sure that they were OK just to get a cheerful response that everything was OK."

Late Friday, the National Weather Service had again issued heavy snow warnings for Oklahoma, Missouri and Kansas, with up to 9 inches expected in some areas. The latest storm could hamper restoration of power or cause new outages, officials said.

In Brief
In an urgent call to action Friday afternoon, the Ohio Association of Medical Equipment Services notified its members that the state's Department of Job & Family Services has filed a Medicaid restrictive contracting rule despite more than 400 comments from stakeholders during a public comment period in September. As currently proposed, the rule could allow for any medical equipment or supply item to be contracted to "one or more provider," the OAMES alert said. The rule is being proposed in response to a recommendation made by the Ohio Commission to Reform Medicaid three years ago. OAMES urged stakeholders to participate in a public hearing on the matter scheduled Jan. 9 at 10 a.m. at the Rhodes State Office Tower in Columbus. For more information, click here to view the public hearing notice or contact the OAMES office at (614) 876-2424 or info@OAMES.org.

AAHomecare reported last week that the total number of cosponsors now stands at 134 for H.R. 621, the Home Oxygen Patient Protection Act, which would repeal a mandated oxygen equipment ownership transfer to Medicare beneficiaries after 36 months. Cosponsors for H.R. 1845, the Tanner-Hobson bill, now number 153. The proposed legislation would soften the effects of competitive bidding. A companion bill in the Senate, S. 1428, has 15 cosponsors.

Hospital emergency department visits for people ages 65 and older increased 26 percent between 1993 and 2003, according to a report published last week in the Annals of Emergency Medicine. "Given that older ED visitors have longer lengths of stay in the ED, are more likely to be admitted and compose a growing proportion of the American population, this finding could have a significant negative effect on ED crowding," according to the report. For patients ages 65 to 74, the increase was 34 percent over the 10-year study period. If the trend continues, ED visits for the 65- to 74-year-old group could nearly double from 6.4 million to 11.7 million by 2013, the report said.

CMS reported last month that aggressive oversight efforts have resulted in a reduction of the number of improper Medicare claims payments from 14.2 percent in 1996, to 4.4 percent in 2006, to 3.9 percent in 2007. During the past three years, recent error rate reductions have led to $11 billion less in improper payments, the agency said. CMS pays more than 1 billion fee-for-service claims each year. The improvement is a result of continued use of "detailed data analysis in targeting areas where erroneous claims processing, inaccurate billing and provider error result in waste, fraud and abuse," CMS said.

People who wish to appeal a Social Security Administration ruling on disability claims can wait as long as three years for a decision, according to a report in the New York Times. The wait for an appeals hearing averages 500 days, with a backlog standing at 755,000. "In the meantime, more and more people have lost their homes, declared bankruptcy or even died while awaiting an appeals hearing," the newspaper said.

Coming Up
The Georgia Association of Medical Equipment Services (GAMES) will hold its Conference on Accreditation and National Competitive Bidding Jan. 10-11 in Atlanta. For more information, call (770) 395-7700 or visit www.gameshme.org.

The Big Sky Association of Medical Equipment Suppliers will hold its quarterly meeting Jan. 11 in Butte, Mont. For more information, call (406) 777-7301.

Bargmann Management/Homecare Collection Service has scheduled "Get Paid Faster and Accurately ... the Billing Process from Intake through Collections" Jan. 17 in Akron, Ohio with speaker Lisa Bargmann. For more information, call (866) 633-9291 or visit www.homecarecollection.com.

The Assistive Technology Industry Association will hold its annual meeting Jan. 30-Feb. 2 in Orlando, Fla. For more information, call (877) 687-2842 or visit www.atia.org.

VGM Group has revised the dates of its National Competitive Bidding Seminar Series. New dates and locations are as follows: Jan. 31 in Chicago; Feb.12 in Phoenix; Feb. 14 in St. Louis; Feb. 26 in Baltimore; Feb. 28 in Charlotte, N.C.; March 4 in San Jose, Calif.; March 6 in Tacoma, Wash.; March 18 in Newark, N.J.; March 20 in Providence, R.I.; April 1 in Columbus, Ohio; April 3 in Detroit; April 15 in Denver; April 17 in Atlanta; April 22 in Tampa, Fla.; April 24 in Houston; April 29 in Nashville, Tenn.; and May 5 in Long Beach, Calif. For more information, call (800) 642-6065 or visit www.vgm.com.

The North Carolina Association for Medical Equipment Services (NCAMES) will hold its Winter Meeting Feb. 5-6 in Greensboro, N.C. For more information, call (919) 387-1221 or visit www.ncames.com.

Send calendar submissions for 2008 to HomeCare Associate Editor Erin Greer at egreer@homecaremag.com.