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| February 23, 2009 | Volume 15, Number 8 |
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ADVERTISEMENT Accreditation deadlines are just around the corner! Is your organization ready? Free teleconferences from The Joint Commission can get you started and keep you moving forward! Join us for a variety of free 1-hour teleconferences where you'll learn how to develop an accreditation game plan, keep it on track and learn what to expect when surveyors come to visit. All you need is a phone to participate! Dates: Feb. 24, March 17 or April 21. Attend one or all! Register today at: www.jointcommission.org/DMEPOS  Table of Contents - 'No Ifs, Ands or Buts' on Competitive Bidding - O2 Advocates Urge Support of Price-Ross Letter--Today - CMS Releases Info on New Oxygen CMN - FDA Workshop Outlines UDI System - NCPA Launches Grassroots Patient Coalition - Don’t Miss Out on Conference Deal for Medtrade Spring - News You Can Use - Invacare's Abraham Victim of Plane Crash - MACs Add 02 Resources; Study Documents Cost-Effectiveness of LTOT - On the HME Calendar For more industry news, features and highlights from our latest issue, please visit our Web site at www.homecaremag.com. Headline News 'No Ifs, Ands or Buts' on Competitive Bidding BALTIMORE--Despite a 60-day delay of the competitive bidding interim final rule, the Medicare bidding project will move forward and Round One will be rebid this year. That was the word from CMS’ Joel Kaiser during an agency Open Door Forum Wednesday afternoon. Congress delayed the DMEPOS bid in July with passage of the Medicare Improvements for Patients and Providers Act. But CMS’ interim final rule--which implements certain provisions under MIPPA--revived the bidding program and was set to take effect Feb. 17. After a memo from the Obama administration advised a delay of pending regulations, however, CMS announced it would stay the effective date of the IFR until April 18. “The rule pretty much speaks for itself,” said Kaiser, deputy director of DMEPOS policy. “There’s a timeliness issue here. The amendments made to the statute are very specific: For example, rebid Round One … in the same manner in the same areas and the same items. However, don’t bid in Puerto Rico; don’t bid [negative pressure wound therapy] in the first round; don’t bid complex rehab wheelchairs. Those are very specific amendments to the statute. “There are really no ifs, ands or buts on how you implement those provisions. They are pretty straightforward,” Kaiser told 582 conference call listeners. “The fact is that the law is what it is. It mandates that Round One be rebid and that competition must occur in 2009.” No decisions have been made yet on a timeline for the rebid, he said. He added that once the transition process from the change in administration is on its way "and we have a timeline and decisions on rebidding, we'll be announcing that." Audience member Eric Sokol of the Power Mobility Commission asked Kaiser whether there would be “an opportunity for impacted stakeholders to talk about some of the lessons learned in the first round." For example, he said, "there's the concern that some providers could be gaming the system" by bidding so low that they were "just bidding to get the contract." Responded Kaiser, “We have implemented provisions to safeguard the program against lowball bids, so that really isn’t an issue.” Regarding comments on the rule, he said, the IFR’s original comment deadline of March 17 remains unchanged. That’s a good thing, according to industry stakeholders, because there are plenty of other issues that need to be addressed. “CMS has refused to take any industry input [on changes to the program],” said Cara Bachenheimer, senior vice president of government relations for Invacare, Elyria, Ohio. Since Congress delayed bidding, “we have had some logical and practical suggestions, but CMS has continued to refuse to accept them,” she said, noting that extension of the effective date for the IFR “slows down the process and gives us an opportunity to gain support to get rid of it entirely." While the comment period would have been “meaningless” before the rule delay--since it concludes 30 days after the IFR was originally scheduled to go into effect--CMS’ delay now gives the industry a chance to air its views, said Pride Mobility Products’ Seth Johnson. “We really need to take advantage of that to do anything we can to specifically identify for the agency where they need to make changes,” said Johnson, the Exeter, Pa.-based manufacturer's vice president of government affairs. Regarding the agency’s full-steam-ahead stance, he said, “I’m not surprised CMS is taking that position. Congress didn’t kill the program, they simply delayed it, and … CMS is required to begin moving toward re-implementation. But clearly Congress intended for them to work in an open and transparent manner with the industry to address the numerous issues that ultimately resulted in Congress’ pulling the program. “We’re really trying to clean up a situation that the previous administration started,” he continued. “The past administration strongly believed that competitive bidding is an appropriate program, and as they were looking to modernize the Medicare system, they were very wedded to that.” Johnson said he is hopeful the Obama administration will take a different path. “The fact that we were able to get an extension in the effective date of the IFR is a positive sign that the new administration really does want to take a very comprehensive look at the program to determine whether they want to move forward in this direction or go in a different direction … A lot has changed since the rule was published, and I’m optimistic we can work with the new administration to find a way to stop competitive bidding.” For the present, Bachenheimer said, the industry must pursue “parallel strategies”--both through administrative and legislative means--to derail the program. “But we have to monitor CMS closely,” she said. For a HomeCare Monday report on the IFR, including a link to its full text, click here. To submit electronic coments on the IFR, go to www.regulations.gov. Enter file code CMS-1561-IFC and click on "Go." The left-hand column of the next screen is headed “Narrow Results.” Under "Document Type," click on "Rules,” and that will take you to the actual rule. Click on "Send a Comment or Submission." Fill in the information required under "Submitter Information" and your comments. In your comments, refer to file code CMS-1561-IFC. In another announcement during the Open Door call, Sandra Bastinelli, who oversees CMS’ DMEPOS accreditation program, said the agency had received some questions about a delay in accreditation, “but there has been no delay," she said. "You must obtain accreditation by Sept. 30, 2009, in order to retain or obtain your Medicare Part B billing number.” Bastinelli also clarified that physician-owned pharmacies are not exempt from accreditation. If the pharmacy bills Medicare Part B for DMEPOS, it must meet the Sept. 30, 2009, accreditation deadline. For information about accreditation requirements and a list of CMS accreditors for DMEPOS, click here. O2 Advocates Urge Support of Price-Ross Letter--Today WASHINGTON--With a deadline looming at close of business today, home oxygen providers and other stakeholders pressed legislators last week to sign on to a bipartisan “Dear Colleague” letter calling for appropriate payments for home oxygen therapy. “We are pressing every button we can press to get everyone to call their congressman,” said Wayne Stanfield, president and CEO of the National Association of Independent Medical Equipment Suppliers. “The drop-dead deadline is Monday.” As of Friday, 59 legislators had signed on to the letter, authored by Reps. Tom Price, R-Ga.; Mike Ross, D-Ark.; Jo Ann Emerson, R-Mo.; and Heath Shuler, D-N.C. Crafted with the aid of the American Association for Homecare, the letter asks members of the powerful Ways and Means and Energy and Commerce committees, as well the top leaders in the House of Representatives, to urge CMS to provide appropriate payments for home oxygen throughout the period of the patient’s medical need. A Senate letter is also being drafted. “There’s still time to call those offices,” said Cara Bachenheimer, senior vice president of government relations for Invacare, Elyria, Ohio. While there is no “magic number” of signatures, Bachenheimer said, “the more the better.” Providers are looking for relief from the 36-month cap that went into effect Jan. 1, saying it is unworkable. Post-cap payment rules require providers to continue service to beneficiaries for an additional 24 months, including patients who move outside the provider’s service area. The cap and payment rules have worked a major hardship on Neal Hansen, owner of Hansen Homecare Specialty Services in Ketchikan, Alaska. “We are in a situation where we have to travel so far,” said Hansen, whose business is 600 miles away from Seattle and 600 miles from Anchorage. “We have to go to the outer islands. You can take a ferry over, but you have to wait a day to come back. It costs close to $900 a [round] trip. We try to do everything by mail and float plane.” But not everything can be handled that way. Hansen often travels to Prince of Wales Island or Annette Island to service oxygen patients there. With reimbursement being what it is, however, he’s not sure how much longer he can continue to do that. Reimbursement must go up, he said, “or we are out of business on the outer islands. To take that service away would be pathetic. It would be catastrophic for some people.” No other oxygen provider serves the islands, Hansen said. “They all refer [patients] to me because I am the only one crazy enough to do it.” He and other oxygen providers are hopeful that Congress will provide some relief. “My opinion is that Congress is looking for reform,” said Joan Cross, co-owner of C&C Homecare in Bradenton, Fla. “They don’t like what they are hearing. They are looking to reform oxygen.” Cross said she is encouraging her legislators to sign on to the letter, and she believes they will. John Reed, COO of Pro2 Respiratory Services in Cincinnati, spoke to his representatives during an AAHomecare fly-in Feb. 11. He said he was encouraged by the reception the Ohio delegation got. “We were there on the Hill the day of the stimulus package,” he said, “so we saw that the timing was not going to benefit us. But we were amazed how much time they sat with us. I think we do have a group of people who are trying to balance the cost of care and do it in a way that is responsible.” Reed said his group spent a lot of time educating legislators. “They could all recite the prices of an Internet oxygen concentrator,” he noted. “We tried to communicate very clearly [the realities of the business]” and detailed the current reimbursement model that doesn’t pay for services. “I think the message is working,” he said. Two Ohio legislators signed on right away, and he is hopeful others will also support the Price-Ross letter. In addition, stakeholders are working to reach consensus on long-term oxygen reform. Toward that end, earlier this month AAHomecare formed the New Oxygen Coalition, or NOC, after many state HME associations said they could not support an overhaul plan backed by AAHomecare and the Council for Quality Respiratory Care. After a meeting Feb. 11, the coalition is attempting to reach a clear consensus on a plan to present to Congress, but as of Friday, stakeholders remained divided. “There is still a considerable movement of providers that feel some immediate relief must be obtained from whatever source we can [get it],” said NAIMES' Stanfield. “The vast majority feel that a repeal of the cap is the only solution to get things back to a level point where you can talk long-term reform.” Stanfield is among nine members of a NOC workgoup charged with ironing out the reform plan. Other members include AAHomecare Chairman Alan Landauer; Lisa Getson, executive vice president of Apria Healthcare; Chris Kane of Pacific Pulmonary; Joe Lewarski, vice president of Invacare's respiratory group; John Gallagher of VGM; Don Clayback of The MED Group; Montana provider Mike Calcaterra of the Big Sky Association of Medical Equipment Services; and provider Jason Rogers, president of the Georgia Association for Medical Equipment Services. The AAHomecare/CQRC plan calls for the cap to be repealed and for oxygen to be removed from any competitive bidding project, but it also includes a case-mix adjusted payment system some independent providers don't like. Both Calcaterra and Rogers have presented alternative plans (see HomeCare Monday, Feb. 9). Bachenheimer noted the AAHomecare/CQRC plan and the other plans that have been floated have an “extraordinarily similar” framework. “The devil’s in the details,” she said. “We just need to get everybody on the same page.” To read the Price-Ross sign-on letter in full, click here. To e-mail U.S. representatives, visit www.house.gov and click “Write Your Representative” on the top toolbar. To contact representatives by phone, call the U.S. Capitol switchboard at 202/224-3121.
How do you plan to support the industry's legislative and regulatory efforts this year? To vote in HomeCare's monthly Web poll, visit www.homecaremag.com. CMS Releases Info on New Oxygen CMN BALTIMORE--Through a listserv message from the DME MACs last week, CMS released information on the use of certificates of medical necessity related to its new oxygen rules. According to the message, there are four situations in which a new 36-month rental period can begin and a new initial CMN is required: the initial use of home oxygen; resuming use after a break in medical necessity during the 36-month rental period for at least 60 days; replacement because the patient has reached the five-year reasonable useful lifetime; and replacement due to irreparable damage, theft or loss of equipment. CMS reminded providers that a written order is required when replacing equipment, and said the CMN can serve as a substitute for a written order if it meets the requirements for a detailed written order. The changes will be incorporated in a future revision of the oxygen LCD, the announcement said. For a PDF of the full message on the Jurisdiction A (NHIC) Web site, click here. FDA Workshop Outlines UDI System GAITHERSBURG, Md.--On Feb. 12, the U.S. Food and Drug Administration convened a public workshop on development of a unique device identification system for medical devices under the FDA Amendments Act of 2007, which mandates the UDI. The FDA has been investigating such a system--which could facilitate device recalls and provde the opportunity to detect early warning signs of a defective device--for several years. When implemented, the system will require that: the label of a device bear a unique identifier, unless an alternative location is specified by the FDA or unless an exception is made for particular devices; such a UDI be identified through distribution and use; and that the unique identifier include the device lot or serial number if specified by the FDA. The workshop announcement listed the following questions: 1. What types of devices or particular devices should be subject to
the requirements of a UDI system? Which types of devices or particular
devices should be excepted?
Other issues included how software products that work with medical
devices would be identified, the need for global harmonization of one
standard and the importance that all medical databases should be able to
exchange accurate data on the tracking and monitoring of devices
seamlessly.
Potential coding systems for the UDI system include GS1, HIBCC or NDC
using radio frequency identification (RFID), 2D bar coding or linear bar
coding.
NCPA Launches Grassroots Patient Coalition ALEXANDRIA, Va.--The National Community Pharmacists Association has launched a grassroots lobbying effort that it hopes will drive the community pharmacy message to Congress. The organization, which represents 23,000 community pharmacies, said patients can sign up to become grassroots activists through their local pharmacies at a Web site called Fight4Rx.org. According to the NCPA, pharmacies on average interact with over 100 patients per day. Already, 1,000 pharmacies have begun recruiting patients, "putting the initial goal of 50,000 Fight4Rx patients by the end of 2009 well within reach," the NCPA said. The site includes briefs on pharmacy patient issues, Medicare and health care news updates, and a video featuring pharmacy experts. Patients will also get a monthly e-mail newsletter. “When necessary, Fight4Rx will encourage patients to contact their elected officials” via an 800 number or e-mail, the NCPA said. According to a report in The Politico, those issues might include preventing Medicare and Medicaid pharmacy reimbursement cuts, allowing small pharmacies to negotiate drug prices directly with the government and stopping mandates that would require patients in government health programs to use mail-order pharmacies. The campaign will also include television ads featuring local pharmacies in various markets and ads on consumer health Web sites, the news report said. “I believe the Fight4Rx online community will lead us to fair and common-sense health care policies in the United States by empowering patients to let their voices be heard in establishing the pharmacy home of their choice,” said Holly Henry, RPh, NCPA president. Don’t Miss Out on Conference Deal for Medtrade Spring ALPHARETTA, Ga.--Legislative and regulatory issues, increased operational efficiency and improved patient care will headline the educational conference at Medtrade Spring, according to show producer Nielsen Business Media. The mid-year event is set March 24–26 at the Las Vegas Convention Center. HME providers and other home health care professionals will have access to over 60 educational sessions that directly address the industry’s foremost challenges and opportunities, show officials said, with a special conference rate of $99 good through Feb. 25 (Wednesday). The deal includes admission to all regular conference sessions, the Medtrade Spring Expo and the Medtrade Madness Reception on Wednesday, March 25, a networking event on the show floor. “The HME industry is an integral part of our nation’s health care system, and the Medtrade Spring conference is dedicated to providing tools that enable these professionals to enhance the care they provide to home care patients while maximizing their success,” said Medtrade Director Kevin Gaffney. The educational conference features sessions in nine separate tracks, including accreditation, business operations, industry updates, information technology, legislative and regulatory issues, oxygen and respiratory issues, rehabilitation and assistive technology, reimbursement and sales and marketing. Continuing education units will be offered for the oxygen and rehab tracks. “[Medtrade's] Educational Advisory Board works diligently to ensure the educational program for Medtrade Spring is on-target with the needs of the HME industry,” said Kim Kianka-Roberti, senior director of education and meetings for AAHomecare. “Attendance at this year’s event is critical for all providers as they face a new round of regulatory battles, reduced reimbursement and increasing challenges.” For more information, visit www.medtrade.com. News You Can Use Having trouble keeping up? To catch up on the latest headlines, visit www.homecaremag.com or click below: New HME Direct Delivery Company on Horizon Former SADMERC Director Calls for Stiffer Fraud-and-Abuse Measures Price Asks House Colleagues to Act on Oxygen Payments Shuler Calls on Congress to End Competitive Bidding Ross Rallies Home Care Advocates at Fly-in One More Time: AAHomecare Rolls Out Anti-Fraud Plan Obituary Invacare's Abraham Victim of Plane Crash BUFFALO, N.Y.--Invacare Corp. lost a member of its team Feb. 12 in the crash of Flight 3407. Mary Abraham, a regional trainer for the Elyria, Ohio-based manufcturer, was killed in the Continental Airlines crash, which took the lives of all 49 aboard and one person on the ground. The 44-year-old Abraham, a respiratory therapist, had worked at Invacare for 10 years as a product manager and trainer, most recently in the Maine to New Jersey region. She is survived by parents George K. and Damasa Abraham, siblings, nieces and nephews. Among many interests, Abraham, a retired First Sergeant of the U.S. Army Reserve, was active in greyhound rescue. Invacare is coordinating the collection of condolence cards for the family and donations in Abraham's name to a greyhound rescue program through Carolyn Paris, c/o Invacare, One Invacare Way, Elyria, Ohio 44036. In Brief MACs Add 02 Resources; Study Documents Cost-Effectiveness of LTOT Cigna Government Services, the Jurisdiction C DME MAC, has posted updated oxygen frequently asked questions on its Web site. To view the FAQs, click here. The Jurisdiction C DME MAC will also host several oxygen Webinars March 2, March 3 and March 12. For information, click here. Noridian Administrative Services, the DME MAC for
Jurisdiction D, has added a Web page dedicated to the changes affecting
oxygen and oxygen equipment, including information on what happens
during and after the 36-month rental period, beneficiary issues,
replacement of equipment, changes of equipment during the reasonable
useful lifetime period, continuous use and proof of delivery. Access the
page through www.noridianmedicare.com/dme
on the "News/Publications" tab under "What's New/Latest Updates."
Lincare Predicts Rough 2009 As for 2009, while the company said it
it still evaluating the potential impact of Medicare reimbursement
changes, it estimated revenues and operating income this year "will be
negatively impacted by approximately $240 million to $255 million." That
includes $110 million resulting from the 9.5 percent cut for products
inititially included in Round One of competitive bidding and additional
reductions for stationary oxygen equipment of approximately 2.5 percent
contained in CMS' 2009 fee schedule. The estimate also includes $130
million to $145 million in reductions related to the 36-month oxygen
cap.
ResMed Posts Record Results
Sensiotec UWB Monitor Gets FDA Clearance VGM Postpones Competitive Bidding Series
HHS Releases ICD-10 Codes States Could Save with Shift in Financing A former tow truck driver, Lopez learned how to commit health care fraud from a former customer, defendant Angel Castillo Jr., the statement said. In 2007, Castillo got a 19-year sentence for submitting more than $48 million in false claims. Lopez used Castillo’s business model, banking and medical billing contacts to set up his own fraud scheme, officials said. Lopez laundered more than $3.3 million he got from Medicare by using friends and others to cash hundreds of checks. In connection with the investigation, the U.S. Secret Service recovered more than $778,000 in cash, a 2007 Mercedes CL 550, a 2008 Cadillac Escalade, Rolex watches and other jewelry. Coming Up On the HME Calendar The National Home Infusion Association (NHIA) Annual Conference and Exposition will take place March 1-5 in Baltimore. In conjunction, the "NHIA Legislative Hill Day" is being held in Washington March 5. For information, call 703/549-3740 or visit www.nhia.org. The Health Industry Distributors Association (HIDA) will hold its 2009 Executive Conference March 3-6 in Dallas. For information, visit www.hida.org or call 703/549-4432. The California Association of Medical Products
Suppliers (CAMPS) will hold its annual convention March 4-5 in Irvine,
Calif. Visit www.campsone.org
for more information.
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