On Nov. 20, CMS will post an audio recording of the teleconference, which also included a host of questions from the audience of 860 listeners, to the Special Open Door Forum Web site at www.cms.hhs.gov/OpenDoorForums/05_ODF_SpecialODF.asp. The recording will be available for 30 days.

For HME Providers, Medicare Home Sleep Testing Bites the Dust
BALTIMORE--Along with a slew of new oxygen payment rules, Medicare's 2009 Physician Fee Schedule put the final nail in the Medicare home sleep testing coffin for HME providers.

Still, attorney Neil Caesar said the final rule is more favorable when it comes to referrals.

“The much harsher first version of the rule would have prohibited all referrals between a sleep lab and a CPAP device supplier if there was any sort of financial relationship between them, no matter how remote,” said Caesar, lead attorney at the Health Law Center, Greenville, S.C. “The old rule prohibited referrals if the DME supplier owned the sleep lab. The new rule appears to allow such referrals. Now the only issues are whether the relationship satisfies the anti-kickback rules and the Stark Law.”

As for the provider's role in home sleep testing for Medicare patients, a July 7 proposed rule included the prohibition, but the wording in the lengthy fee schedule leaves little wiggle room:

“No Medicare payment will be made to the supplier of a CPAP device if that supplier, or its affiliate, is directly or indirectly the provider of the sleep test used to diagnose the beneficiary with obstructive sleep apnea. This prohibition does not apply if the sleep test is an attended facility-based polysomnogram.”

The rule defines “affiliate” as “a person or organization that is related to another person or organization through a compensation arrangement or ownership."

It defines “attended facility-based polysomnogram” as “a comprehensive diagnostic sleep test including at least electroencephalography, electro-oculography, electromyography, heart rate or electrocardiography, airflow, breathing effort, and arterial oxygen saturation furnished in a sleep laboratory facility in which a technologist supervises the recording during sleep time and has the ability to intervene if needed."

The key now, said Melanie P. Arledge, is to focus on non-Medicare patients. “Our home sleep testing business is thriving, and we are so busy that we need more devices than we already have,” says Arledge, manager at Carlsbad, Calif-based Progressive Medical. “Looking for revenue in different areas is what it's all about. There are different payer sources out there other than Medicare, and different payer sources other than commercial insurance.”

For Todd Cressler, owner of CressCare Medical in Harrisburg, Pa., any dabbling in the home sleep testing realm would be frowned upon by local sleep labs. “For us here in central Pennsylvania, the rule is just fine,” said Cressler. “The labs in our area are still very much against home sleep testing. Anyone who is thought to provide home testing would be banned from getting another CPAP referral. Hopefully some labs in the area will offer it, and more folks will be prescribed therapy. Then we can set them up and do what we do best.”

Arledge said most Medicare-age patients have already progressed too far in the disease process, and therefore should be studied in the lab.

“DMEs in home sleep testing should be looking at that younger population and stopping that disease process,” said Arledge. “We are out there working with business organizations to decrease their workers' comp costs and increase their productivity.”

For a PDF of CMS' 1,459-page 2009 Physician Fee Schedule, click here.

Advocacy Groups Call for End of Medicare Waiting Period
WASHINGTON--A group of more than 75 health advocacy organizations is urging the next Congress to end the 24-month wait for Medicare coverage faced by people with disabilities.

At a Nov. 12 press conference at the Capitol, the Coalition to End the Two-Year Wait for Medicare--including the Alzheimer’s Association, the American Association of People with Disabilities, the Amputee Coalition of America, the Arthritis Foundation, the COPD Foundation, the National Multiple Sclerosis Society, United Cerebral Palsy and others--launched its campaign.

“This coalition will give voice to people with disabilities and their families who struggle to pay medical bills or who go without critically needed care as they wait for Medicare coverage to begin,” said Robert M. Hayes, president of the Medicare Rights Center, in a statement. “This senseless delay in health coverage for the most vulnerable among us must end.”

In 1972, Congress extended Medicare coverage to those determined by the Social Security Administration to have a disability that prevents them from working. But legislators also mandated a two-year waiting period, starting from the date of the eligibility for Social Security Disability Insurance benefits, before Medicare coverage begins.

In a letter addressed to Democratic and Republican leaders of the Senate Finance Committee, the House Ways and Means Committee and the House Committee on Energy and Commerce, the coalition called for health coverage for people with disabilities to be at the forefront of efforts to cover the uninsured.

"This arcane rule continues to exist despite the potential harm it causes to the health of the 1.5 million people waiting for coverage,” the coalition letter reads. “Nearly 40 percent of these individuals are without health insurance coverage at some point during their wait for Medicare; 24 percent have no health insurance during this entire period. Many cannot afford to pay COBRA premiums to maintain coverage from their former employer, and private coverage on the individual market is unavailable or too expensive for this high-cost population …

“The waiting period forces people with severe disabilities to endure two years during which treatment and care of their condition are put at risk,” the letter continues. “Many forgo medical treatment and/or stoop taking medications, compromising their already fragile health and resulting ultimately in conditions more costly to treat when Medicare coverage finally begins."

Legislation to phase out the waiting period over 10 years has been introduced in both the Senate and the House. The Senate bill (S. 2102) is sponsored by Sen. Jeff Bingaman, D-N.M., and cosponsored by 23 senators, including President-elect Barack Obama. The House bill (H.R. 154) is sponsored by Rep. Gene Green, D-Texas, and has 103 cosponsors. The two legislators are trying to get their plan incorporated into a health reform package expected by Obama.

“After receiving a life-altering diagnosis, people with disabilities, such as the half million people with young-onset Alzheimer’s disease, must then wait two full years for Medicare coverage--at a time when they need coverage the most,” said Brenda Sulick, director of federal health policy for the Alzheimer’s Association. “Those with profound disabilities are often overlooked. With so many lives at stake, now is the time to act.”

Intel Enters Home Care Arena
SANTA CLARA, Calif.--Last week, Intel Corp. rolled out its first medical device with its introduction of the Intel Health Guide, a care management tool for patients with chronic conditions.

The Health Guide, which received FDA 510(k) clearance in July, combines an in-home patient device as well as an online interface, offering interactive tools for care management. The system--which includes a touchscreen, a Web cam, Bluetooth wireless connectivity and a speaker--collects vital signs and gives patient reminders, displays educational content and offers video conferencing and alerts.

"The Health Guide is a step forward in offering more personalized and effective management of chronic health conditions in the home," said Louis Burns, vice president and general manager of Intel’s Digital Health Group. "Intel has spent years researching the needs of both caregivers and patients, and we are now moving to launch a series of products that will help extend care from the hospital to the home. Our products will help address the challenges of an aging population and rising rates of chronic disease."

Intel will license educational content from the Mayo Clinic for the system, and is working with the American Heart Association to create care plans for management of patients with heart failure. Pilot studies of the device are also planned with Aetna, Erickson Retirement Communities, Providence Medical Group in Oregon and SCAN Health Plan to focus on improving outcomes for patients with heart failure, diabetes, hypertension and COPD.

Additionally, Intel plans to use the system’s core components to build products targeted for areas such as independent living and programs for health and wellness management and to support devices such as mobile phones and handhelds.

American Medical Alert Corp., which provides remote patient monitoring devices and 24/7 health care communication services, is the first U.S. market channel partner for the Health Guide.

DOJ Recoups More than $1 Billion from Health Care Fraud in FY 2008
WASHINGTON--The United States recovered more than $1.1 billion lost to fraud in federal health care programs for fiscal 2008, the Department of Justice said Nov. 10.

Cases involving whistleblowers accounted for a majority of the recoveries, according to a DOJ release. The figures bring total recoveries since 1986, when Congress substantially strengthened the False Claims Act, to more than $21 billion.

The DOJ said almost 78 percent of the recoveries in FY 2008, ended Sept. 30, were associated with suits initiated by whistleblowers, called relators, under the False Claims Act's qui tam provisions. Under the law, people who knowingly make false claims for federal funds are liable for three times the government’s loss plus a civil penalty of $5,500 to $11,000 for each claim.

Relators recover 15 to 25 percent of the proceeds of a successful suit if the United States intervenes in the qui tam action, and up to 30 percent if the government declines and the relator pursues the action alone. In fiscal 2008, relators were awarded $198 million for their part in bringing successful cases.

During the year, health care accounted for $1.12 billion of fraud settlements and judgments. HHS reaped the biggest recoveries--notably from pharmaceutical companies--largely attributable to the Medicare and Medicaid programs, the DOJ said.

“Now more than ever, it is crucial that taxpayer dollars aren’t lost to fraud,” said
Gregory G. Katsas, assistant attorney general for the DOJ’s Civil Division. He added that whistleblower complaints do more than recover lost dollars; they also save much more in “aborted schemes and misconduct.”

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