Comments on Oxygen Rules Due Dec. 29
BALTIMORE--CMS is accepting comments on the oxygen regulations until 5 p.m. EST Dec. 29. In commenting, refer to file code CMS-1403-FC. Comments can be submitted in one of four ways:

1. Electronically. You may submit electronic comments on this regulation to www.regulations.gov. Enter the file code in the search bar, then click "Send a comment or submission," fill in the information required and include the file code in your comments.

2. By regular mail. You may mail written comments to the following address ONLY:

CMS-1403-FC 3
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1403-FC
P.O. Box 8013
Baltimore, MD 21244-8013

Allow sufficient time for mailed comments to be received before the close of the comment period.

3. By express or overnight mail. You may send written comments to the following address ONLY:

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1403-FC
Mail Stop C4-26-05
7500 Security Boulevard
Baltimore, MD 21244-1850

4. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to either of the following addresses: 7500 Security Boulevard, Baltimore, MD 21244-1850; or Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201.

Letter to Delay Oxygen Cap Gains Scores of Signatures
WASHINGTON--In an eerie echo of the summer’s frantic bid to derail competitive bidding, HME providers implored federal lawmakers late last week to sign onto a letter to CMS calling for a delay of the 36-month oxygen rental cap.

As of noon Friday, some 70 members of the House of Representatives had agreed to sign the letter, authored by Rep. Heath Shuler, D-N.C, and supported by Rep. Tom Price, R-Ga. In explaining the request to their colleagues, the congressmen said they feared the cap would “hurt the quality of care Medicare patients receive,” and they urged CMS to delay the new oxygen payment rules “until Congress is able to legislatively reform the Medicare policy as it is necessary to the survival of the home medical equipment industry and the quality of care they provide to our nation’s seniors.”

In the letter sent to CMS, addressed to Acting Administrator Kerry Weems, the House members point out that under provisions of the cap, which takes effect Jan. 1, providers will be reimbursed for only one 30-minute routine maintenance visit every six months after the oxygen equipment has capped out. They will also be required to maintain and service the equipment for its “reasonable life” (generally five years under Medicare guidelines) even if the patient moves. As well, they will not be reimbursed for emergency calls or replacement items such as masks.

In their “Dear Colleague” letter, which they titled “Help Protect Home Oxygen Suppliers,” Shuler and Price also noted the looming cap coincides with the 9.5 percent reimbursement cut for product categories in Round 1 of bidding, including oxygen. That cut is also set to go into effect Jan. 1.

“Home oxygen suppliers do more than just drop off equipment to a patient. Many suppliers, particularly smaller ones, have staff on call 24 hours a day to make home visits to repair equipment, drop off replacement supplies and ensure that patients are receiving the proper amount of oxygen,” the letter reads. “Without adequate recognition of the services that home oxygen providers furnish, the quality of care that patients have come to expect will deteriorate, leading to an increase in the number of emergency room visits.”

Cara Bachenheimer, senior vice president of government relations for Invacare, Elyria, Ohio, said the Shuler-Price letter raises the visibility of the industry’s concerns about the oxygen cap.

“Members of Congress need to be educated about the incredible shortcomings of the new oxygen rule,” she said. “That’s really our top priority as an industry. People in Congress are already hearing that. And this does further the message.”

The question, she said, is how to fix the problem permanently. “That’s not an easy answer. In the short term--the next month or two or three--political pressure is the only way to make it happen,” Bachenheimer said. However, she added, “There’s not a piece of legislation that’s going to be happening in the next three months [to tack the bill to].”

Bachenheimer said there are two possible fixes: an oxygen payment policy reform, which would be “patient-centric, related to patient needs” and is a long-term fix; and a legislative mandate, which would be a short-term fix.

Wayne Stanfield, president and CEO of the National Association of Independent Medical Equipment Suppliers, said the industry must try everything it can to get the cap delayed.

“It’s NAIMES’ belief that every path should be followed,” he said. “I think this is an important attempt to try and delay it. I certainly hope that [the letter] strikes a chord with someone in CMS who realizes that it is a problem.”

Your Post-Cap O2 Questions Asked and Answered
AMARILLO, Texas--With all the confusion surrounding CMS’ new post-cap oxygen payment rules, it’s time for some answers. Beginning a special series today for HomeCare Monday, Lisa K. Smith, Esq., an attorney with the Health Care Group at Brown & Fortunato, P.C., a law firm based in Amarillo, Texas, responds to several of home medical equipment providers’ most common questions about the new rules.

Question: What are the ramifications from CMS, based on current information, if the current supplier cannot find a supplier willing to accept patients moving from its service area?
Answer: If it is during the 36-month cap period, the current supplier should do its best to assist the patient in locating a supplier to service the patient in the area where the patient is moving, but the current supplier has no liability if it is unable to find one. If it is after the 36-month cap period, the supplier will have to make arrangements for servicing the patient by either allowing the patient to take the supplier’s equipment to the new location and contracting with a local supplier to service the equipment as needed, or paying whatever it takes to get a supplier to provide equipment and services to the patient. In the case of oxygen contents, I believe it should be sufficient to find a supplier willing to provide contents to the patient, whether on an assigned or unassigned basis.

Question: If a home filling unit is provided, can the supplier automatically bill monthly charges for oxygen contents?
Answer: If it is a system where the patient fills portable tanks from an oxygen generating device (i.e. concentrator), the answer is no. If it is a liquid or gas system requiring contents delivery that the patient uses to fill its portable, then the supplier can bill for portable contents. If the patient uses the stationary unit with its contents as his or her stationary oxygen supply, then the supplier can also bill for stationary contents.

Question: Can a supplier limit the number of portable tanks it provides to the patient to the amount used by the patient in the home? Can the supplier ask that the patient pick up the tanks from its facility or does it have to deliver?
Answer: CMS has stated that the supplier cannot limit the portable oxygen contents to only the amount used in the home, as it is understood that portable contents will be used both inside and outside the home. The Supplier Standards require the supplier to deliver equipment and supplies, so the supplier cannot ask the patient to pick up tanks from its facility.

Lisa K. Smith, who is Board Certified in Health Law by the Texas Board of Legal Specialization, represents HME companies, pharmacies, hospitals and other health care providers throughout the United States. She can be contacted at lsmith@bf-law.com.

Obama Sets the Stage for Health Care Reform
WASHINGTON--The rebuilding of the nation’s health care structure will be led by former South Dakota Sen. Tom Daschle in a dual role as secretary of the Department of Health and Human Services and director of the newly formed White House Office of Health Reform, President-elect Barack Obama announced last week.

Calling Daschle the “lead architect” of the reform plan, Obama also announced Jeanne Lambrew as the deputy director of the White House Office of Health Reform. Lambrew, a professor of public affairs at the University of Texas, was Daschle’s co-author on a book on health care called “Critical: What We Can Do about the Health Care Crisis,” and also worked on health policy in the Clinton administration.

In making the announcements, Obama tagged health care as a high priority even in the face of the nation’s collapsing financial structure.

“Year after year, our leaders offer up detailed health care plans with great fanfare and promise, only to see them fall, derailed by Washington politics and influence peddling,” Obama said. “This simply cannot continue.”

He added, “It’s not something that we can put off because we are in an emergency. This is part of the emergency.”

For his part, Daschle, in remarks at the press conference announcing his appointment, said fixing health care “is--and has been for many years--our largest domestic policy challenge. We have the most expensive health care system in the world, but we are not the healthiest nation in the world. Our growing costs are unsustainable, and the plight of the uninsured is unconscionable.”

Daschle will waste no time plunging into the system’s reform. Earlier, he announced that the Obama administration would seek public input on health care reform from citizens via community meetings and house parties to be held across the country beginning today and continuing through Dec. 31. Daschle said last week that he would be attending some of those meetings.

Anyone can sign up to hold a meeting by registering on Obama’s transition Web site at www.change.gov. Those signing up can get a special moderator kit to get the discussion going. Data from the meetings will be published on the Web site.

Walt Gorski, vice president of government relations for the American Association for Homecare, applauded the idea.

“At these types of meetings, people typically outline problems,” he said. “What this will do is show the shortcomings for those who have insurance as well as highlight the horrific stories of people who do not have insurance and face health problems.”

Gorski and others also noted that the meetings could provide forums for the HME industry to get its message out.

“These forums will be an opportunity for us to raise awareness of HME and also highlight some of our broad themes, such as the value we bring to patients,” Gorski said. He added that even though it is unlikely the industry would be able to drill down to issues like competitive bidding and the 36-month oxygen rental cut, the forums “provide a very good opportunity to raise our issues.”

Cara Bachenheimer, senior vice president of government relations for Elyria, Ohio-based Invacare, said industry stakeholders need to seize the opportunity to educate Obama and his staff about home care.

“There are new audiences, fresh faces,” she said, adding that many of those who had negative views of home care will be gone with the new administration. She suggested that providers not only take part in the town hall meetings but that they involve patients to help tell the HME story.

“Bring somebody who is an actual user of oxygen or a mobility device,” she advised. “That would be great. Keep the message simple. Talk about how people prefer to be cared for in their homes. Make it personal.”

The town hall meetings offer the HME industry not only a place at the table but also a view of a developing health reform plan, according to Seth Johnson, vice president for government affairs for Pride Mobility Products, Exeter, Pa.

The process that Obama’s team has set into play, he said, offers transparency and will allow the industry to “monitor the health care plan to make sure that any future plan does not limit or insufficiently cover DME. I see it as a real significant opportunity for the industry to work with the new administration.”

Both Johnson and Bachenheimer said they believe Daschle will bring a good understanding of home health care to the HHS office.

“I am very confident that we are going to have a friendly ear in Tom Daschle in articulating our message and promoting and seeing the benefits of home care included in future health reform plans,” Johnson said.

That Daschle will have his hands full with his two jobs is likely an understatement. In addition to an overhaul of the health care system, broad changes in the way Medicare and Medicaid are administered are expected, as are changes in the State Children’s Health Insurance Program.

For the HME industry, controversy over the looming 36-month oxygen cap, the 9.5 percent reimbursement cut in 10 Medicare product categories and the probable return of competitive bidding are all likely to involve Daschle somehow.

Meanwhile, Obama’s call for public input on health care has prompted member services organization VGM Group to schedule a town hall meeting in Waterloo, Iowa. The event will be held at 10:30 a.m. Friday at the company’s corporate headquarters at 1111 W. San Marnan Drive.

The member services group has invited Democratic Sen. Tom Harkin, and Republican Sen. Charles Grassley and Democratic Rep. Bruce Braley to attend, as well as area hospital administrators, referral sources, physicians and Medicare beneficiaries.

“VGM has been serving the home health care marketplace for 20 years and the American people, and [is] happy to participate in the conversation about health care reform,” said Van G. Miller, CEO and founder.

Provider News
Home Care Medical Expands; Medical Service Co. Gives Back
NEW BERLIN, Wisc.--Home Care Medical has expanded with a newly redesigned 8,400-sq. ft. retail store in Milwaukee. “Our motto at our retail facility is try before you buy! At our retail store, a client has the ability to try scooters, walkers, wheelchairs, designer lift chairs and more,” said Patti Kelnhofer, manager. “There is no better way to determine if a product is right for you than to try it first.” The store features several rooms displaying bathroom, kitchen and bedroom set-ups. The retail expansion also included creation of a Respiratory Care Center with three private fitting rooms. The provider plans to expand its human resource department to add a corporate trainer, and relocation of its service center to the New Berlin corporate location in 2009.

CLEVELAND--Medical Service Company’s annual November food drive brought in 2,000 pounds of food for the food pantry at University Settlement, a non-profit organization serving the Cleveland area with senior and child care, parenting programs, youth mentoring and a hunger center. The company also held food drives at its Canton, Mansfield and Youngstown branches. “Medical Service Company is an organization that really cares for both our patients and our community,” said Joel D. Marx, CEO. “Our employees look forward to our annual food drive as a chance to give back to the communities who continually support us.” In the last three years, the Ohio provider has donated more than three-and-a-half tons of food.

EARTH CITY, Mo.--United Seating & Mobility announced it has completed the acquisition of Georgia-based Aplus Mobility. USM, which specializes in complex rehab seating and mobility, said the addition will allow it to offer expanded levels of service for Augusta, Ga., and surrounding communities, including Evans, Ga., where its new service center will be located.

Newsmakers
Parsons Moves to Harmar; Grau Joins MED
SARASOTA, Fla.--Harmar Mobility has appointed Michael E. Parsons vice president of sales and marketing. Previously, Parsons served as North American vice president of sales for Invacare Corp. and held various other positions throughout his 27-year career at the company, including credit manager, assistant treasurer and president of Invalease, Invacare's leasing subsidiary. In his new role, Parsons will be responsible for all aspects of Harmar's sales and marketing under the leadership of Chad Williams, president and CEO.

LUBBOCK, Texas--The MED Group announced the addition of Wayne Grau as sales team leader. In his new role, Grau will work with MED's regional managers as well as calling on the group's members, and will facilitate account management responsibilities as MED progresses with a new customer relations management system. Previously, Grau worked for Pride Mobility Products as a sales rep, regional manager and in governmental affairs.

In Brief
New Competitive Bidding Rule on the Way; CMS Clarifies Accreditation Exemptions
WASHINGTON--According to Washington insiders, an interim final rule for DMEPOS competitive bidding could be out soon, as publication by Dec. 19 would allow its enactment before a new administration is in place. CMS has sent the rule, which governs changes to the competitive bidding program under the Medicare Improvements for Patients and Providers Act, to the Office of Management and Budget where it is now in final clearance. MIPPA delayed Round 1 of bidding and also required several reforms to the controversial program, which went live July 1 but was halted when Congress passed the law July 15. Titled “Limited Changes to the Competitive Acquisition of Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)(CMS-1561-IFC),” an abstract for the rule from HHS-CMS reads: “This interim final rule as mandated by section 154 of MIPPA requires the temporary delay of Round 1 of the DMEPOS Competitive Bidding Program such that a new competition occurs excluding certain services. Section 154 of MIPPA establishes other requirements for the program such as providing a process for giving suppliers feedback on missing financial documents and mandating the disclosure of subcontractors under a competitive bidding program. Section 154 also mandates additional refinements to be implemented before phasing in future rounds of the program.”

BALTIMORE--Last week, CMS sent a clarification about exactly which professionals are exempt from the Sept. 30, 2009, DMEPOS accreditation deadline--and which aren’t--under changes in the Medicare Improvements for Patients and Providers Act. According to the notice, the “eligible professionals” who are exempt include physicians, physical therapists, occupational therapists, qualified speech-language pathologists, physician assistants and nurse practitioners. In addition, “other persons” including orthotists, prosthetists, opticians and audiologists are also exempt from CMS’ mandatory deadline. The notice said CMS will define--by rulemaking in 2009--how the quality standards apply to these “eligible professionals and other persons.” It also said pedorthotists, mastectomy fitters, orthopaedic fitters/technicians and athletic trainers are not exempt and must meet the accreditation deadline.

NASHVILLE, Tenn.--The Jurisdiction C DME MAC said it will be starting a prepayment medical review of randomly selected claims for glucose monitor test strips (A4253) and lancets (A4259). The review will focus on non-insulin treated beneficiaries (KS modifier) who are receiving quantities of supplies that exceed the utilization guidelines defined in the LCD for glucose monitors. Suppliers of claims selected for review will receive a documentation request letter in the mail. The documentation, accompanied by a copy of the request letter, must be returned by 30 days from the date of the letter or the claim will be denied as not medically necessary. Read the entire notice at: www.cignagovernmentservices.com/jc/pubs/news/2008/1208/cope8887.html.

WASHINGTON--Bayer HealthCare has agreed to pay the United States $97.5 million plus interest to settle allegations that it paid kickbacks to 11 diabetic suppliers and caused those suppliers to submit false claims to Medicare. According to a Department of Justice press release, the settlement resolves allegations that Tarrytown, N.Y.-based Bayer engaged in a "cash-for-patient" scheme from 1998 through 2007 in which the company paid the diabetic suppliers more than $3 million to switch their patients to Bayer’s products from those manufactured by its competitors. The largest share of the kickbacks--$2.5 million--went to Liberty Medical Supply, according to the DOJ, which said they were based on the number of patients the company converted to Bayer products and were disguised as payments for advertising between 1998 and 2002. The settlement also covers $375,000 in alleged payments to 10 other diabetic suppliers. Bayer also agreed to a corporate integrity agreement with HHS' Office of Inspector General that will "enable OIG to closely monitor company practices affectng federal health care programs and beneficiaries," the DOJ said. "If medical device manufacturers want to serve Medicare beneficiaries they must follow the law," said Gregory G. Katsas, assistant attorney general for the DOJ's Civil Division. "Paying health care suppliers to place a particular brand of device with Medicare beneficiaries violates the law and will not be tolerated."

INDIANAPOLIS--Effective Monday, Jan. 5, 2009, the NGS Common Electronic Data Interchange Helpdesk will be open from 9:00 a.m. to 7:00 p.m. ET Monday through Friday. The CEDI Helpdesk number is 866/311-9184, or you can email NGS.CEDIHelpdesk@wellpoint.com

BALTIMORE--The transcript of the CMS ICD-10-CM/PCS National Provider Conference Call for Other Part A and Part B Providers that was held Nov. 12 is now available at: www.cms.hhs.gov/ContractorLearningResources/Downloads/November12calltranscript.pdf.

BALTIMORE--CMS has rolled out its new Internet-based Provider Enrollment, Chain and Ownership System, or PECOS, that lets physicians and other practitioners in 24 states and the District of Columbia enroll in Medicare, check on the status of an application or make a change in their enrollment information. CMS said next year, it will make the system available to all suppliers--except DMEPOS providers.

WASHINGTON--A New Jersey entrepreneur who tried to register his company's 9 mm Palm Pistol as a Class I medical device had his hopes shot down last week by the U.S. Food and Drug Administration. The Palm Pistol is a single-shot firearm designed for the elderly and disabled who "may have limited strength or manual dexterity," as described by Maplewood, N.J.-based Constitution Arms. The oval-shaped Palm Pistol fits in the palm of a hand with the barrel protruding out from between the fingers and, instead of a trigger, has a button that can be pushed with the thumb. According to press reports, company owner Matthew M. Carmel said the elderly and disabled are easy targets for criminals and the Palm Pistol could offer them some protection. When Carmel decided to start advertising to seniors, he contacted the FDA and was advised to register Constitution Arms as a medical device facility and list the Palm Pistol as a a "daily activity assist device." But after a flurry of press reports and Internet commotion, the FDA released a statement saying it had determined the product is not a medical device. Carmel said he is disappointed in the decision, but will continue to market the Palm Pistol. He's taking deposits for an initial production run on the company's Web site, which says the ATF has classified the gun as a "standard pistol."

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