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June 1, 2009 Volume 15, Number 23

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Table of Contents
- CMS Says ‘Get Ready for Competitive Bidding’
- Bachenheimer: ‘Critical’ Battle Ahead on NCB
- Hopeful about the PAOC? Not Exactly, Says Pride’s Johnson
- AAHomecare to Congress: Cut HME Off of the Cut List
- Independents Rank Bidding as Issue No. 1
- Q&A: The 'Dos and Don'ts' of Purchasing Leads
- From HomeCareMag.com: News You Can Use
- Knight Directs SeQual Sales; Rossnagel Promoted at Sunrise
- Not Getting Accredited? Tell CMS; Moves, Reviews and Other News

For more industry news, features and highlights from our latest issue, please visit our Web site at www.homecaremag.com.

Special Alert
CMS Says ‘Get Ready for Competitive Bidding’
BALTIMORE--In an email sent Friday morning, CMS announced the next steps in its implementation of the Round One rebid of competitive bidding, including the general timeline for opening the bid window in the fall of this year.

According to the notice, the rebid will occur in the following MSAs (the same as the first Round One with the exclusion of Puerto Rico):

• Cincinnati – Middletown (Ohio, Kentucky and Indiana)
• Cleveland – Elyria – Mentor (Ohio)
• Charlotte – Gastonia – Concord (North Carolina and South Carolina)
• Dallas – Fort Worth – Arlington (Texas)
• Kansas City (Missouri and Kansas)
• Miami – Fort Lauderdale – Miami Beach (Florida)
• Orlando (Florida)
• Pittsburgh (Pennsylvania)
• Riverside – San Bernadino – Ontario (California)

The rebid will include the following product categories (the same as the first Round One except negative pressure wound therapy items and group 3 complex rehabilitative power wheelchairs are excluded):

• Oxygen and Oxygen Equipment
• Standard Power Wheelchairs, Scooters, and Related Accessories
• Complex Rehabilitative Power Wheelchairs and Related Accessories (Group 2 only)
• Mail-Order Replacement Diabetic Supplies
• Enteral Nutrients, Equipment and Supplies
• Continuous Positive Airway Pressure (CPAP) machines, Respiratory Assist Devices (RADs), and Related Supplies and Accessories
• Hospital Beds and Related Accessories
• Walkers and Related Accessories
• Support Surfaces (Group 2 mattresses and overlays) (in Miami only)

“Congress mandated that competition for the Round One rebid occur in 2009. CMS is announcing the next steps to implement the DMEPOS competitive bidding program now to give the supplier community ample time to prepare as well as inform other stakeholders,” said Charlene Frizzera, CMS acting administrator, in a release accompanying the announcement. “This program generated substantial savings for Medicare and beneficiaries who used these items and supplies in the competitive bidding areas last summer and is consistent with CMS’ goal to pay appropriately for Medicare items and services.”

CMS will now begin general “pre-bidding” awareness and education efforts on key steps DMEPOS providers need to take to be ready for registration and bidding, including getting appropriate state licenses, updating Medicare enrollment files with the National Supplier Clearinghouse and getting accredited and bonded, the release said.

The agency reiterated it will convene a meeting of the Program Advisory and Oversight Committee (PAOC) on June 4 before announcing the detailed timeline for the bidding program in the summer. (See story this issue.)

“The bidder registration period is expected to begin this summer before bidding opens in the fall. CMS has made a number of process improvements for the Round One rebid, such as an upgraded on-line bid submission system, early bidder education and increased oversight of bidders that are new to product categories or competitive bidding areas to ensure they meet CMS’ requirements,” the agency said.

The Medicare Improvements for Patients and Providers Act excluded certain DMEPOS items and areas from bidding and provided an exemption to the program for hospitals that furnish certain types of DMEPOS items to their own patients. “However," the release stated, "MIPPA did not fundamentally change the nature of the competitive bidding program as established by the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) or the existing competitive bidding regulations that were finalized in 2007.”

The full CMS press release is available at www.cms.hhs.gov/apps/media/press_releases.asp.

A CMS fact sheet on the bidding program is available at www.cms.hhs.gov/apps/media/fact_sheets.asp.

The CMS email announcement follows in its entirety:

The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), enacted on July 15, 2008, made limited changes to the Medicare Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program, including a requirement that competition to re-bid Round 1 occur in 2009. On January 16, 2009, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period that incorporates into regulations only those provisions of MIPPA related to the DMEPOS competitive bidding program that are self-implementing and necessary to conduct the Round 1 rebid competition in 2009. That rule became effective on April 18, 2009. To ensure that suppliers have ample time to prepare for the competition, CMS has announced the following next steps for the program:

SPRING 2009
• CMS BEGINS PRE-BIDDING SUPPLIER AWARENESS CAMPAIGN
• PROGRAM ADVISORY AND OVERSIGHT COMMITTEE (PAOC) MEETING (JUNE 4, 2009)

SUMMER 2009
• CMS ANNOUNCES BIDDING SCHEDULE/SCHEDULE OF EDUCATION EVENTS
• CMS BEGINS BIDDER EDUCATION CAMPAIGN
• BIDDER REGISTRATION PERIOD TO OBTAIN USER IDS AND PASSWORDS BEGINS

FALL 2009
• BIDDING BEGINS

If you are a supplier interested in bidding, prepare now – don’t wait!

UPDATE YOUR NSC FILES: DMEPOS supplier standard # 2 requires ALL suppliers to notify the National Supplier Clearinghouse (NSC) of any change to the information provided on the Medicare enrollment application (CMS-855S) within 30 days of the change. DMEPOS suppliers should use the 3/09 version of the CMS-855S and should review and update:

• The list of products and services found in section 2.D;
• The Authorized Official(s) information in sections 6A and 15; and
• The correspondence address in section 2A2 of the CMS-855S.
This is especially important for suppliers who will be involved in the Medicare DMEPOS Competitive Bidding Program. These suppliers must ensure the information listed on their supplier files is accurate to enable participation in this program. Information and instructions on how to submit a change of information may be found on the NSC Web site (www.palmettogba.com/nsc) and by following this path: Supplier Enrollment/Change of Information/Change of Information Guide.

GET LICENSED: Suppliers submitting a bid for a product category in a competitive bidding area (CBA) must meet all DMEPOS state licensure requirements and other applicable state licensure requirements, if any, for that product category for every state in that CBA. Prior to submitting a bid for a CBA and product category, the supplier must have a copy of the applicable state licenses on file with the NSC. As part of the bid evaluation we will verify with the NSC that the supplier has on file a copy of all applicable required state license(s).

GET ACCREDITED: CMS would like to remind DMEPOS suppliers again that time is running out to obtain accreditation by the September 30, 2009 deadline or risk having their Medicare Part B billing privileges revoked on October 1, 2009. Accreditation takes an average of 6 months to complete. It is very important for DMEPOS suppliers to contact an accreditation organization right away to obtain information about the accreditation process and submit an application. Suppliers must be accredited for a product category in order to submit a bid for that product category. CMS cannot contract with suppliers that are not accredited by a CMS-approved accreditation organization.

Further information on the DMEPOS accreditation requirements along with a list of the accreditation organizations and those professionals and other persons exempted from accreditation may be found at the CMS website: www.cms.hhs.gov/MedicareProviderSupEnroll/01_Overview.asp.

GET BONDED: CMS would like to remind DMEPOS suppliers that certain suppliers will need to obtain and submit a surety bond by the October 2, 2009 deadline or risk having their Medicare Part B billing privileges revoked. Suppliers subject to the bonding requirement must be bonded in order to bid in the DMEPOS competitive bidding program. A list of sureties from which a bond can be secured is found at the Department of the Treasury’s “List of Certified (Surety Bond) Companies;” the Web site is located at: www.fms.treas.gov/c570/c570_a-z.html.

Visit the CMS Web site for the latest information on the DMEPOS competitive bidding program.


Headline News
Bachenheimer: ‘Critical’ Battle Ahead on NCB
ATLANTA--Cara Bachenheimer is swift to identify the top three issues for the home medical equipment industry: “Competitive bidding.”

“Competitive bidding is number one, number two and number three,” said Bachenheimer, senior vice president of government relations for Invacare Corp., Elyria, Ohio. “We’ve got other issues. But if you’re not around, it doesn’t matter how much CMS is paying for oxygen.”

On Friday, CMS laid out its schedule for the rebid of Round One (see top story this issue). If the national competitive bidding program goes through as the agency plans, it has the power to eliminate up to 90 percent of Medicare providers in the target areas and severely cripple beneficiary access to products, experts have predicted. It is the industry’s most critical battle, Bachenheimer said.

A recent survey by the Committee to Save Independent HME Suppliers showed providers agree. With 242 companies from 42 states weighing in to rank the industry’s most important issues, competitive bidding came out on top (followed by repeal of the cap and restoration of the 9.5 percent cut to complex rehab).

After its rocky implementation, Round One of the bidding project was halted last July when Congress passed the Medicare Improvements for Patients and Providers Act. Among other things, MIPPA directed CMS to fix the laundry list of procedural and other problems plaguing the project.

Stakeholders had hoped the Obama administration would repeal the mandate for competitive bidding. But a delay in confirming a new secretary for the Department of Health and Human Services--Kathleen Sebelius only assumed that post in late April--and the continued absence of a CMS administrator have worked against that possibility.

“Clearly, we have been hampered,” said Bachenheimer, adding that CMS’ Friday announcement puts the HME industry in peril. “It appears that CMS is moving forward with the exact same language [on bidding] as it did last year,” she said. “They said in their press release that MIPPA didn’t make any meaningful changes.”

Bidding Needs a Big Fix
The two most crucial areas that need to be reformed, Bachenheimer said, are supplier selection and the bid process. The selection process needs to be “more rational” and guarantee that providers are 100 percent legitimate, she said. As it stands, the bid process encourages desperate bids, reduces the number of suppliers and distorts the real competitive system, she said.

“Those are the two areas that need to be changed,” Bachenheimer said, but “CMS has made it clear through the [interim final rule] and other press releases since July that there is absolutely no change in those areas.”

It is imperative that providers muster their muscle to fight the project, she continued.

“People ask ‘What should I do right now?’ The reason we were successful last year is that we had an incredible grassroots effort,” Bachenheimer said. “We need to be doing the same thing right now … Timing is of the essence. The urgency is now to be communicating with members of Congress.”

In Washington today through Wednesday for the American Association for Homecare’s annual Legislative Conference, some 250 participants are expected to request that legislators once again halt the bidding program. Other HME groups are also urging their members to connect with legislators to make the case for eliminating the DMEPOS bid.

“We have to continue our political support [for those who supported MIPPA], the letters, the phone calls,” said Bachenheimer.

Beth Bowen, executive director of the North Carolina and Virginia state associations, agreed. “It is vitally important that we continue to have face-to-face meetings with our members of Congress as we build that relationship by email, phone and site visits throughout the year,” she said.

That may be the only way to derail competitive bidding, according to Bachenheimer, who does not believe CMS will change the program on its own; that mandate will have to come from Congress.

“Unless someone comes in and tells [CMS] they have to make changes, that’s not going to happen,” she said. “Clearly, you have to tell CMS what they have to do. It has to be an extremely detailed legislative mandate saying, ‘You have to make these changes.’”

There is some support on Capitol Hill for eliminating or, at the least, reforming the bid program, she pointed out. “People who supported [MIPPA] last year are actually surprised that CMS is moving forward in the same manner as last year. [They] are irritated [because] they intended for CMS to take a more serious look and actually make some significant changes,” Bachenheimer said.

Arguments that Resonate
In her view, CMS is not complying with the spirit of the law. “It wasn’t just delay the program for delay’s sake. The intent was to take a look and say, ‘What went wrong?’

“That’s the message right now for Congress: CMS hasn’t made any changes and is expecting a different outcome. That’s the message we need to keep making and make sure folks on the Hill understand,” Bachenheimer said.

Also, she pointed out, CMS has the ability to add the “any willing provider” provision to the project. That would mean any provider willing to be reimbursed at the new competitive bidding rate could continue to serve Medicare patients.

“The Obama administration has that in its Medicare Advantage plan,” Bachenheimer said. Providers can argue the merits of having consistency in policies, she said, adding: “It’s a way to establish pricing at better rates without this sort of arbitrary fiat that certain providers cannot participate in the Medicare program.”

Then there is the argument that competitive bidding will eliminate a huge percentage of providers from the program, resulting in companies going under and loss of jobs, something the Obama administration does not want to see at a time when the economy is barely breathing.

Such arguments resonate with Democratic leaders on the Hill, Bachenheimer said.

But here are significant hurdles, she said. “We have a lot more sympathy on the House side than the Senate,” she said, noting that Sen. Max Baucus, D-Mont., head of the powerful Finance Committee, has repeatedly stated his support of competitive bidding.

There is also the issue of cost. “If we get support to repeal the program, it is going to be a ‘pay-for’ situation,” Bachenheimer said. “Is the industry going to be able to afford what they seek? That’s so critical; if we can’t get a repeal or the industry is not willing to pay for repeal, what are our other options?”

The fact that providers took a nationwide 9.5 percent reimbursement cut in 10 product categories only paid for last year’s delay of competitive bidding, she noted. So whatever happens, the industry will have to pay for it. And the cost of delaying the program while it is reformed would be less than eliminating it altogether.

“We are between a rock and a hard place, but there are works in progress at this time,” Bachenheimer said. “I can’t say anymore.”

Beyond Bidding
Beyond competitive bidding, she said, the biggest issue is oxygen. “I am very concerned that oxygen cuts are going to be resurrected by the Senate Finance Committee,” Bachenheimer said.

She champions the Home Oxygen Patient Protection (HOPP) Act (H.R. 2373), which would eliminate the oxygen rental cap, but believes it must be melded with an oxygen reform bill.

On Friday, AAHomecare issued a background paper for legislation to reform the Medicare oxygen benefit. “Budget-neutral oxygen reform legislation will ensure consistent and comprehensive services for Medicare beneficiaries while eliminating the current 36-month reimbursement cap and establishing a bundled payment for the duration of time in which home oxygen therapy is provided,” the association said.

Industry stakeholders hope the plan, which was devised by the AAHomecare New Oxygen Coalition, can be included in legislation this year. That could be in the health care reform package Congress is working feverishly to assemble. The Obama administration wants health reform by the end of the year, and both the House and Senate have said they want plans finalized by August.

“Ideally, we will get both bills and they will be combined in the health care package this year,” Bachenheimer said. “While CMS is fixing the payment issue, you immediately fix the 36-month cap issue.”

The carve-out of complex rehab from the 9.5 percent reimbursement cut could be harder. “I’d be kidding if I said it’s not going to be a difficult job,” Bachenheimer said. Legislators maintain that the industry agreed to the cut last year to pay for the delay of competitive bidding, she explained, and asking for the carve-out is akin to reneging on the agreement.

In any case, there is a window of time that narrows daily.

“The train is moving,” said Bachenheimer. “The House has a pretty aggressive schedule--health care reform language released in two weeks, mark-ups to follow.”

Providers need to be out there talking to legislators and making the case for fair legislation and regulations, she said.

That’s exactly what Bowen and her team--22 providers from North Carolina and 12 from Virginia--plan to do at the AAHomecare lobbying conference, she said. “Obviously, we will be asking for congressional support on the HOPP Act, assistance to the complex rehab companies and elimination of the competitive bidding program. We have a lot to accomplish!”


Have you obtained a DMEPOS surety bond yet? To vote in HomeCare's monthly Web poll, visit www.homecaremag.com.



Hopeful about the PAOC? Not Exactly, Says Pride’s Johnson
BALTIMORE--CMS has finalized the agenda for the first meeting of its new Program Advisory and Oversight Committee, established to advise the agency on competitive bidding.

Set to convene Thursday, the PAOC will look at the online bidding system for the program, which was plagued with problems in Round One, along with financial documentation, another area providers say caused numerous unwarranted disqualifications in last year’s bid. Discussion will also include legislative requirements under the Medicare Improvements for Patients and Providers Act, licensure, accreditation and subcontracting requirements, new supplier issues and mail order for diabetic testing supplies.

A tentative timeline for the bidding program, released Friday by CMS, also will be outlined.

It’s a full agenda, but the one-day meeting still doesn’t include “some of the things it should,” according to Seth Johnson, vice president of government affairs for Exeter, Pa.-based Pride Mobility Products and a member of the first PAOC. Last October, CMS unexpectedly ended the term of the previous PAOC and formed a new 17-member panel chaired by John Blum of CMS and Tom Jeffers of Hill Rom. (See “Call for New PAOC Puzzles Current Members,” Oct. 13, 2008).

“One of the things that is absent is any opportunity for the PAOC members to talk about their experiences going through the program last year,” said Johnson. “They are the industry experts identified by Medicare, and they are the ones who can talk about the changes that need to take place to improve the program prior to any restart later this year.”

While there is a 45-minute public comment period built in at the end of the meeting day, that’s not enough time to detail the program’s “significant flaws” and talk about how to correct them, Johnson said.

He pointed out “they only gave a half-hour to the online bidding system, when there were a number of issues with that system last year.” That issue alone needs to be a substantial discussion, he said. “I would like to hear an overview from CMS as to exactly what improvements they have made to address the problems, and I don’t see how they can do that in half an hour.”

Johnson said he would also like to hear from CMS “what their plans are to Beta test the system so we don’t see the same types of errors come up again” during the bidding window.

“Another controversial issue and a very important subject that needs a lot of discussion is financial documentation,” Johnson continued. “One of the most surprising changes is that they have reduced the amount of financial information providers are required to provide from three years down to one year. Maybe CMS’ perspective is that due to the many disqualifications from last year that limiting the documentation will fix that problem, but there are a lot of concerns about requiring less information rather than more.

“When you look at some of the winners last year,” he noted, “especially in some of the MSAs where you saw the most provider reduction, there are lots of questions about bidders being qualified to provide the products and services that did win and a lot of qualified providers that did not win. I would think they would strengthen these requirements for bidders, not relax or weaken them.”

After potential irregularities turned up among power wheelchair bid winners in the Riverside, Calif., bidding area, for example, Pride called for an investigation into the matter. Johnson said last September, his company got an acknowledgement from CMS that it had received the information but has heard nothing since. Four California congressmen who called for an investigation also have not received a response, “which is very disappointing,” Johnson said. (For more, see “Pride Calls for Investigation in Riverside CBA,” May 5, 2008.)

“Before any restart of the program, there needs to be a full and independent analysis conducted of all of the issues that were identified and any problems with bidding from last year, and those issues need to be resolved in an appropriate manner,” he said.

One good thing, Johnson said, is that providers and others who don’t get to attend this week’s PAOC meeting in person have a 30-day period in which to submit written comments about the presentations provided by Medicare and its competitive bidding contractor (Palmetto GBA) during the meeting.

In it previous incarnation, critics of CMS’ Round One implementation said the PAOC was misnamed: While its name indicates the committee members had oversight powers, they did not, and while they were to function as well in an advisory capacity, CMS seldom took their advice.

Whether CMS will take the PAOC’s advice this time around is questionable, Johnson said. “I lost a lot of hope on April 17, when even absent leadership at HHS and CMS, Medicare allowed the Interim Final Rule to go into effect, essentially finalizing the structure and framework that we had in the program last year … I don’t have a whole lot of hope that this new PAOC will be any different than the previous PAOC.

“I hope I’m wrong,” Johnson continued, “but this administration seems every bit as wedded to competitive bidding as the previous administration. They were unwilling to rescind the IFR or delay its implementation.

“All the way up to the very top, this administration believes competitive bidding is a program that needs to advance. They do not appear willing to eliminate the program or even to talk about refining the program to make it better.”

For more on the PAOC and a list of current members, see www.cms.hhs.gov/DMEPOSCompetitiveBid/09_Program_Advisory_and_Oversight_Committee_PAOC.asp.

For more on Thursday’s meeting, see www.cms.hhs.gov/DMEPOSCompetitiveBid/downloads/Info_for_Registration_dmepos_060409.pdf.

The meeting schedule follows:

PROGRAM ADVISORY AND OVERSIGHT COMMITTEE (PAOC) MEETING AGENDA, THURSDAY, JUNE 04, 2009, MARRIOTT HOTEL BWI
8:00 – 8:30 a.m. Public Registration
8:30 – 8:45 a.m. Opening Remarks
8:45 – 9:00 a.m. Introduction of New PAOC Committee
9:00 – 10:00 a.m. Background on the Program
• Standard Payment Rules
• Competitive Bidding Demonstrations
• Medicare Modernization Act of 2003
• 2008 Legislative Refinements
10:00 – 10:30 a.m. On-Line Bidding System
10:30 – 10:45 a.m. Mid-Morning Break
10:45 – 11:30 a.m. Education on Program Requirements and Bidder Responsibilities
11:30 – 12:00 p.m. Financial Documentation
12:00 – 1:30 p.m. LUNCH (On your own)
1:30 – 2:30 p.m. Licensure, Accreditation, and Subcontracting Requirements
2:30 – 3:15 p.m. New Supplier Issues
3:15 – 3:30 p.m. Mid-Afternoon Break
3:30 – 4:00 p.m. Mail Order - Diabetic Testing Supplies
4:00 – 4:15 p.m. Tentative Timeline
4:15 – 5:00 p.m. Public Comments


AAHomecare to Congress: Cut HME Off of the Cut List
ARLINGTON, Va.--On Tuesday, the American Association for Homecare sent a letter to the Senate Finance Committee about the list of options for financing health reform through cuts in Medicare. The association message: Take HME off the list.

“The HME sector has been subjected to a long series of deep and disproportionate reductions in reimbursements in recent years that are having a negative impact on the quality of care that Medicare beneficiaries and physicians alike have come to expect,” read the letter, addressed to committee Chairman Max Baucus, D-Mont., and Ranking Member Charles Grassley, R-Iowa.

Pointing out the nationwide 9.5 percent cut in 10 product categories and the 36-month cap on oxygen payments that took effect Jan. 1, the six-page letter recommended that Congress:

• Refrain from further cuts to oxygen and enact budget-neutral reform to improve quality of care and increase cost transparency;

• End the “competitive” bidding program, which is a flawed administrative pricing mechanism that produces arbitrary and capricious pricing that will reduce access to care and put thousands of small providers out of business;

• Restore appropriate payment for complex rehab to preserve beneficiary independence; and

• Enact effective and aggressive fraud-and-abuse measures that focus on preventing and detecting Medicare fraud early, which is a more proactive approach than the current “pay-and-chase” system of combating fraud.

A recent report from the Finance Committee includes reimbursement reductions for HME on a list of potential revenue options that could pay for health care reform. Although no specific cuts were recommended, the report does make a reference to ensuring “appropriate payments” for oxygen and power wheelchairs.

For more, see “DME Targeted on List of Cuts to Pay for Health Reform,” May 19.

Independents Rank Bidding as Issue No. 1
MARTINEZ, Ga.--Based on a new survey from CSI:HME, the Committee to Save Independent HME Suppliers, independent providers are more worried about competitive bidding than anything else, although repeal of the 36-month cap on home oxygen rental is a close second.

Of 242 people responding to a poll asking them to rank the industry’s most important issues, 111 listed the repeal of competitive bidding as their No. 1 concern, followed by repeal of the oxygen cap (102) and, at a distant third, eliminating the 9.5 percent reimbursement cut on complex rehab equipment (14). Six respondents said carving oxygen out of DME into a stand-alone provider category was their top priority, while another six put strengthening supplier site inspection requirements at the head of their list. Three said amending the surety body requirement to exempt all but new applicants or providers with adverse actions in the past five years was their most important concern.

Those participating in the survey represent 567 locations in 42 states and employ 7,784 people.

Commenting on the emphasis providers placed on competitive bidding, Tom Inman, president of Virginia Home Medical and CSI:HME member, said it reflects the fear that many providers “can’t survive competitive bidding.” Esta Willman, president of California's Medi-Source Equipment & Supply, agreed, noting that failure to win a bid on top of the recent cuts to oxygen fees will put many companies out of usiness. “Independent providers like me will have difficulty surviving unless they win the bid,” said Willman.

CSI:HME Managing Director David Petsch, owner of Petsch Respiratory in Martinez, Ga., said he was not surprised to see competitive bidding as the top concern. “With the unreasonably low fees in the first bid, most providers are very concerned that the rebid prices will be driven even lower by the fear of being left out,” he said.

Petsch added the recently formed organization will use the survey results to set its priorities for legislative action. A more detailed survey on competitive bidding will be launched in a few days, the group said, followed by a survey on oxygen and how the cap has affected patients and suppliers.

Other results from the survey show:

• 233 respondents support H.R. 2373 (the Home Oxygen Patient Protection Act), which would repeal the 36-month cap on oxygen payments.
• 76 support an oxygen reform plan that moves home oxygen from the DMEPOS benefit into a separate provider category. (Forty-nine respondents did not support the plan, and 117 said they were undecided.)
• 85 percent of respondents said they had personally contacted their congressional representatives in 2009.
• 178 said they support having a lobbyist specifically to represent the interests of independent providers.

CSI:HME will hold the current survey open until June 12 to allow additional comments. Take the survey at FreeOnlineSurveys.com/rendersurvey.asp?sid=1ou56qsdhtk1sfd587984.

Q&A: The 'Dos and Don'ts' of Purchasing Leads
AMARILLO, Texas--In a special Q&A for HomeCare Monday, health care attorney Jeff Baird, chairman of the Health Care Group at Brown & Fortunato, addresses the purchase of leads.

"This concept has exploded in popularity over the last six months," Baird said. "It seems like I am advising companies on the 'dos and don'ts' of purchasing leads on a daily basis. While 'purchasing leads' is OK, 'paying for referrals' is a felony. The line between 'purchasing leads' and 'paying for referrals' can be blurry."

Q: I have been approached by several companies that want to "sell leads to me." What does this mean?
A: In order to cut marketing expenses, an increasing number of HME companies are cutting back on sending sales reps into the field and are focusing on purchasing leads. Basically, what this means is that a lead generation company ("ABC") compiles a list of names, addresses, phone numbers and other information about individuals who have expressed an interest in a particular product line (e.g., diabetic supplies). Some of the prospective customers are covered by Medicare, while others are covered by commercial insurance. ABC sells the list to XYZ Medical; XYZ, in turn, calls the names on the list. The compensation paid by XYZ to ABC is on a "per lead" basis (e.g., $10 per name).

Q: How does ABC come up with the leads?
A: ABC may manage a number of Web sites that can be reviewed by prospective customers. A prospective customer can type in his/her name and contact information and check a box indicating consent to be called by a DME company. Prospective customers can cut out, sign and mail to ABC forms out of newspapers, magazines and direct mail pieces that contain their name and contact information and gives their consent to be called by a DME company. Prospective customers can call ABC on a toll-free telephone number in response to television, Internet, radio and print ads. ABC can purchase lists of leads from other companies that acquire leads.

Q: Are there any federal kickback concerns in buying leads?
A: 42 U.S.C. § 1320a-7b(b)--commonly known as the Medicare anti-kickback statute--provides that it is a felony for a person or entity to knowingly and willfully offer or pay any remuneration to induce a person to refer an individual for the furnishing or arranging for the furnishing of any item for which payment may be made under a federal health care program, or the purchase or lease or the recommendation of the purchase or lease of any item for which payment may be made under a federal health care program.

Many courts have adopted the “one purpose” test: If one purpose of a payment is to induce referrals, then the anti-kickback statute is violated regardless of whether the payment is fair market value for legitimate services rendered.

On Nov. 5, 2008, the Office of Inspector General issued Advisory Opinion 08-19 discussing Internet leads in the context of the anti-kickback statute. The proposed arrangement involved one or more Web sites to which patients interested in chiropractic services would enter their zip code. The Web site would then display assigned phone numbers and email addresses of chiropractors within the zip code indicated. When the patient calls the phone number or sends an email, the call or email is routed to the listed chiropractor (and electronically tracked by the advertiser). The advertiser is paid a “per lead” fee based on the routed call or email.

In its opinion, the OIG indicated that it would not seek enforcement action against the parties for the arrangement proposed in the opinion. We highlight some of the factors that were important to the OIG. First, the advertiser in the opinion does not collect “health care information” on the potential patient. Second, the arrangement in the opinion passively routes calls/emails initiated by the lead. Third, the arrangement in the opinion does not actively “steer” patients to a particular provider.

Looking at the anti-kickback statute and the advisory opinion together, it appears that the OIG is comfortable with a DME company paying compensation, on a per lead basis, for “unqualified” leads. Generally, an unqualified lead will consist of name, address, phone number and the prospective customer’s interest in talking to the DME company about its products.

An “unqualified” lead will start moving into the “qualified” category as ABC gathers specific information from the prospective customer, such as age, third-party coverage, diagnosis of illness/disability, products/equipment currently being used and the treating physician’s name. While the purchase of an unqualified (or “raw”) lead is exactly what it is--the purchase of a lead--the purchase of a qualified lead can be construed as the payment for a “referral.” The percentage chance of an unqualified lead becoming a paying customer of the DME company will be low; conversely, the percentage chance of a qualified lead becoming a paying customer will be much higher.

Note that a DME company can purchase qualified leads from ABC if the arrangement meets the requirements of the Personal Services and Management Contracts safe harbor to the anti-kickback statute. Among other requirements, the compensation must be fixed one year in advance (e.g., $50,000 over the next 12 months), the compensation must be the fair market value equivalent of ABC’s services, and the compensation cannot take into account the volume of referrals to be generated by ABC.

Q: Once a DME company purchases leads, are there any restrictions on the company calling the leads?
A: The arrangement needs to be examined within the context of 42 U.S.C. § 1395m(a)(17)--commonly known as the Medicare anti-solicitation statute--which prohibits a DME company from contacting a Medicare beneficiary by telephone concerning the furnishing of a covered item of DME unless (i) the beneficiary has given “written permission” for the contact; (ii) the DME company is contacting the beneficiary only about an item the company has already provided to the beneficiary; or (iii) the DME company has provided at least one covered item to the beneficiary during the 15 months immediately preceding the contact. Exceptions “(ii)” and “(iii)” will not apply to the phone calls to be made by the DME company to the leads; “(i)” is the only applicable exception.

The question, therefore, is whether the DME company has “written permission” to call the lead. If the prospective customer checks a box on a Web page that clearly shows his/her consent to be called (not just “contacted”) by a DME company, then it is unlikely that the government will assert that the anti-solicitation statute is violated. Likewise, if a prospective customer calls a toll-free number and, over the phone, consents to be called by a DME company, then it is unlikely that the government will assert that the anti-solicitation statute is violated. The prudent course of action will be for the phone calls to be recorded.

Q: Are there any HIPAA concerns in buying leads?
A: The arrangement also needs to be examined within the context of the Health Insurance Portability and Accountability Act of 1996, 42 USC § 1320d, and the corresponding regulations contained in title 45, Code of Federal Regulations, parts 160 and 164 (collectively “HIPAA”).

A DME company is subject to the requirements of HIPAA. HIPAA prohibits the use or disclosure of protected health information not specifically permitted or required by HIPAA. PHI includes information that is created or received by a health care provider (such as a DME company) that: relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and (i) that identifies the individual; or (ii) with respect to which there is a reasonable basis to believe the information can be used to identify the individual (45 C.F.R. § 164.103).

This definition would encompass identification and contact information for a lead, as well as the information that relates to the lead’s interest in DME. Therefore, the DME company’s use of the information is subject to HIPAA.

HIPAA defines “marketing” to include “a communication about a product or service that encourages recipients of the communication to purchase or use the product or service” (42 C.F.R. § 164.501). HIPAA prohibits use of PHI for marketing, unless the covered entity (i.e., DME company) obtains written authorization from the potential customer prior to making such communication. The discussion above regarding the prospective customer’s consent applies here.

Q: When a DME company purchases leads from ABC, what protective steps should the DME company take?
A: The contract between ABC and the DME company should include the following: (i) ABC represents to the DME company that leads it purchases from other lead companies, and subsequently sells to the DME company, properly gave their consent to be called by a DME company; (ii) ABC represents that leads it obtains on its own properly gave their consent to be called by a DME company; (iii) the DME company has the right to audit ABC's operations to ascertain if the leads (sold to the DME company by ABC) properly gave their consent to be called by a DME company; and (iv) ABC indemnifies the DME company against any claims made against the DME company on the basis that a lead did not give his/her consent to be called.

Jeffrey S. Baird, Esq., is chairman of the Health Care Group at Brown & Fortunato, P.C., a law firm based in Amarillo, Texas. He represents pharmacies, infusion companies, home medical equipment companies and other health care providers throughout the United States. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization. He can be reached at 806/345-6320 or jbaird@bf-law.com.


Do you have a legal question about an HME issue? Send your questions to HomeCare Monday for consideration by health law firm Brown & Fortunato. We'll publish the answers in an upcoming issue.



From HomeCareMag.com: News You Can Use
Having trouble keeping up? To catch up on the latest headlines, visit www.homecaremag.com or click below:

Two O&P Bills in the House

Study: Undiagnosed Diabetes Costs $2,864 Per Person

CMS Seeks Comments on Rebid of Competitive Bidding Project

OIG Takes Issue with DME Error Rate

DOJ, HHS Combine Forces to Combat Fraud; DME a Target

Air Products Sells Three More to Landauer

Arcadia Sells HME Division

DME Targeted on List of Cuts to Pay for Health Reform

DME MAC D Gives Instruction on Resubmitting Oxygen Claims

ACHC to Offer Sleep Lab Accreditation


Newsmakers
Knight Directs SeQual Sales; Rossnagel Promoted at Sunrise
SAN DIEGO--Oxygen systems manufacturer SeQual Technologies has appointed Adrian Knight director of sales, the Americas. Knight will be responsible for sales team leadership as well as general management responsibilities within North and South America.

Since 2007, Knight has been SeQual’s national manager of clinical support, where he worked with clinicians to create CEU and pulmonary rehab programs for both providers and their referral sources. His background as an RT and former owner of a DME and sleep lab give him the knowledge to draw from, according to a company release. Knight will also be working closely with product management and engineering to provide input from customers on new product development.

“We believe by utilizing our technology, a provider can grow his business through a non-delivery model without sacrificing patient care,” Knight said. “That message shows great promise in this industry. I look forward to this new and exciting opportunity.”

Rossnagel Promoted at Sunrise
LONGMONT, Colo.--Thomas Rossnagel has taken over the reins of Sunrise Medical-Mobility, the Longmont, Colo.-based company announced.

Rossnagel, most recently senior vice president and managing director of Sunrise Europe, succeeds Michael N. Cannizzaro, who will continue as chairman of the company's board of directors. The new president and CEO said he was “thrilled” with the new position.

He added, “Under Michael Cannizzaro's leadership, a lot has been accomplished in refocusing the company that I now will be building on.” Rossnagel said he will work “to position Sunrise for strong future growth.”

Cannizzaro praised his successor, saying, “Over the past 13 years at Sunrise, Thomas has demonstrated a superb track record for both operational and strategic excellence. There is no one better suited to carry on what I have implemented and take the company to the next level.”

In Brief
Not Getting Accredited? Tell CMS; Moves, Reviews and Other News
HME providers who choose not to become accredited at this time need to submit an amended CMS-855S application that reflects their voluntary termination, CMS announced last week. That will prevent the provider from being revoked and subsequently barred from the Medicare program, the agency said. For pharmacies that choose not to become accredited but wish to remain a DMEPOS provider for drugs and biologicals only, an amended CMS 855S must be completed. Find the latest version of the application at www.cms.hhs.gov/cmsforms/downloads/cms855s.pdf. For a revised MLN Matters Article (SE0903) on accreditation requirements, go to www.cms.hhs.gov/MLNMattersArticles/downloads/SE0903.pdf.

AAHomecare Mobility Conference Coming Up
Changes in Medicare policy for power and manual mobility, seating and positioning and repair services have catapulted providers into a state of confusion, and at times, into financial loss. Learn how to cope at AAHomecare's Mobility Conference June 18.

Speakers will include Dr. Paul Hughes, medical director for Jurisdiction A; Mark Schmeler, PhD, OTR/L, ATP, from the Department of Rehabilitation Science & Technology at the University of Pittsburgh; and Georgie Blackburn, vice president of government relations for Blackburn's, Tarentum, Pa. The program is sponsored jointly by AAHomecare, the University of Pittsburgh Medical Center and Pitt's Department of Rehabilitation and Technology, with an education grant from Pride Mobility Products. CEUs will be awared to participants who attend in person at the University of Pittsburgh or by video conference.

For more information, contact Kim Kianka at kimk@aahomecare.org.

Providers Headed to the Heartland
VGM members are headed to the Heartland next week for the buying group's annual Heartland Conference, June 8-10 in Waterloo, Iowa. Learn what's new in the industry from health care experts, earn up to 17 contact hours for CEUs in eight job-specific education tracks and network with other members, presenters and vendors. For information, visit www.vgm.com.

NGS Continues Look at Glucose Supply Claims
National Government Services, the Jurisdiction B DME MAC, reminded providers last week that it is continuing a prepayment targeted medical review for glucose testing supplies billed with the KS modifier (non-insulin treated beneficiaries). NGS said findings from the review during the first quarter of 2009 show that "a large percentage of claims are being denied for lack of response to documentation requests." Find a more in-depth article on the issue on the NGS Web site under Education and Support - Tools and Materials - Clinical Education.

PHS Gets Pediatric Nurse Award
In recognition of its "outstanding and innovative in-home service to children with special needs," St. Paul, Minn.-based Pediatric Home Service has been selected as the 2009 Organization of the Year by the Minnesota Chapter of the National Association of Pediatric Nurse Practitioners. PHS is an independent pediatric home care company that provides specialized health care services to technology-supported children in the home. For more on the company, see "Safe at Home," HomeCare, October 2008.

Get to Know the Codes
CMS' Special Edition MLN Matters article SE0832- Revised, called "The ICD-10 CM/PCS-The Next Generation of Coding," outlines general information for providers on the International Classification of Diseases, 10th Edition (ICD-10) classification system. Compared to the current ICD-9 system, ICD-10 offers more detailed information in order to capture advancements in clinical medicine, the agency said. Get up close and personal with the new coding system by reading the complete update.

MED Partners with HNA
The MED Group, Lubbock, Texas, and Phoenix-based Healthcare Networks of America have announced an agreement that allows MED members to enroll in HNA's panel of accredited DME providers. HNA said expansion of its panel, previously comprised only of physicians, is an important step in growing its network. MED will also serve as HNA’s credentialing and compliance manager for those members who enroll.

DSC Makes a Move
Dynamic Seminars & Consulting, led by popular HomeCare columnist Louis Feuer, is moving. As of June 12, the company's new location will be: 2955 NW 126 Ave., #307, Pembroke Pines, FL 33323. Phone: 954/838-7504. Fax: 954/838-7510. The address may be new, Feuer said, but the "commitment to training and education has not changed since our opening in 1977." For Feuer's latest column, check www.HomeCareMag.com.

Family Medical Spending Climbs Again
Average medical spending for a typical American family increased 7.4 percent between 2008 and 2009, according to a Milliman Inc. report. Total medical costs in 2009 for a typical family of four will be $16,771, compared with $15,609 in 2008, the resport said. While the percentage of the cost increase declined for the third straight year, the total dollar increase was the highest since 2006, the study found.

To revisit this news any time during the week, go to www.homecaremonday.com.


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