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November 2, 2009 Volume 15, Number 46

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Table of Contents
- Competitive Bidding for Manufacturers?
- TAHCS’ Johnson: Welcome to H.R. 3790
- Providers Struggle with PECOS: 'We Have Zero Control'
- Conference Moves Rehab Sector Forward on Separate Benefit
- CMS Issues Final Rule on Oxygen Maintenance for 2010
- '60 Minutes' Points TV Finger at Medicare Fraud
- Q&A: Here We Go Again--Competitive Bidding, Part II
- Sleep Titans Team Up on Education for PCPs
- HME Expo Discontinued

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

Headline News
Competitive Bidding for Manufacturers?
WASHINGTON--House Democrats moved another step closer to revamping health care with the Oct. 29 release of H.R. 3962, dubbed the "Affordable Health Care for America Act." While most Americans focused on the hotly debated public insurance option, home care advocates were caught off guard by a provision that instructs the Government Accountability Office to evaluate the establishment of a competitive bidding program for DME manufacturers.

The proposal--buried within Section 1149 of the 1,990-page bill--"is a new addition to the House bill and is not in the current version of the Senate health reform legislation," said Seth Johnson, vice president of government affairs for Pride Mobility Products, Exeter, Pa. "It would require the GAO comptroller to conduct a study to evaluate the potential establishment of a program to acquire DME and supplies through a competitive bidding process among manufacturers of such equipment and supplies. The GAO report is due to Congress within 12 months of enactment of the bill."

According to the National Association of Independent Medical Equipment Suppliers, the concept is similar to a program being used in California for incontinence products. "The basic concept is that manufacturers would bid to supply a selected product. Suppliers would be paid this fee and would buy the product from the manufacturers at a price that is below the bid fee," NAIMES reported, noting that House Ways and Means Committee staff had brought up the issue in discussions with the group earlier this year.

Michael Reinemer, vice president, communications and policy, for the American Association for Homecare, pointed out that the legislation is not actually proposing manufacturer bidding at this point. Instead, Reinemer reiterated that the bill merely proposes that the idea be considered. AAHomecare has scheduled a meeting with House committee staff to learn more about the proposal.

In a Thursday afternoon update, AAHomecare reported that the GAO study mandated by the bill would encompass the following topics:

• Identification of types of DME and supplies that would be appropriate for bidding under such a program.

• Recommendations on how to structure such an acquisition program to promote fiscal responsibility while also ensuring beneficiary access to high quality equipment and supplies.

• Recommendations on how such a program could be phased in and on what geographic level would bidding be most appropriate.

• In addition to price, recommendations on criteria that could be factored into the bidding process.

• Recommendations on how suppliers could be compensated for furnishing and servicing equipment and supplies acquired under such a program.

• Comparison of such a program to the current competitive bidding program under Medicare for durable medical equipment, as well as any other similar Federal acquisition programs, such as the General Services Administration's vehicle purchasing program.

• Any other consideration relevant to the acquisition, supply, and service of durable medical equipment and supplies that is deemed appropriate by the Comptroller General.

AAHomecare also reported that Section 222 of the bill states that DME, prosthetics, orthotics and related supplies are now included in the minimum essential benefits package that qualified health insurance plans must cover. The association had lobbied for inclusion of HME in the minimum benefits package.

Additional analyses from AAHomecare, NAIMES and VGM Group also noted the bill:

• Implements annual productivity adjustments (reductions) for "certain DME" beginning in 2013, but "certain DME" was not defined. AAHomecare said homecaremag.com/news/dme-schedule-payment-cut-20090824/"> additional HME CPI reductions that had earlier been proposed by Rep. Gene Green, D-Texas, do not appear to be contained anywhere in the bill.

• Adds an option for Medicare beneficiaries to take ownership of Group 3 support surfaces after the 13-month capped rental period ends. The option must be offered in the 10th month. If rental is chosen, suppliers are required to provide and support the item for the remainder of the useful life (five years) at no charge to Medicare. Unspecified service and maintenance would be paid.

• Requires that a supplier who provides oxygen to a patient during the 27th month is required to provide the equipment through the 60th month regardless of circumstances or location. According to NAIMES, this change "effectively moves the commitment to the patient from the 36th month to the 27th month while leaving the cap at 36 months. It specifically states this, regardless of circumstances, unless another supplier has accepted responsibility through the 60th month."

• Establishes rules that would restart the 36-month rental period for oxygen if the supplier goes bankrupt after 24 months of payments have been made for the patient.

• Except for competitive bidding, exempts pharmacies only from accreditation if they only provide diabetic supplies, canes and crutches. Some restrictions apply.

• Adds a 2.5 percent excise tax on the sale of medical devices (products sold at retail stores would be exempt). The proposal, which would raise approximately $20 billion, is similar to one in the Senate Finance Committee's health reform bill, but the Senate version levies a fee on the medical device manufacturers themselves. (See Manufacturers Marshal Forces to Battle $40 Billion Tax, Sept. 21.)

Pride's Johnson also confirmed that elimination of the first-month purchase option for standard power wheelchairs is included in the House bill, a move that experts expected and one industry advocates continue to fight.

"The provision does provide for an exemption of the Round 1.2 competitive bidding areas where contracts are entered into by Oct. 1, 2010," said Johnson, adding: "The industry remains focused on securing a budget-neutral alternative that would preserve the purchase option prior to final passage of the bill."

H.R. 3962's estimated cost of $894 billion over 10 years squeaks in just under President Obama's stated goal of staying under $900 billion. The House will likely consider the bill in earnest as early as this week, and vote on final passage prior to Veterans Day (Nov. 11).

Congressional Quarterly reported that the legislation would be "paid for largely by a surtax on the adjusted gross income of individuals making more than $500,000, and married couples making more than $1 million. The bill contains new revenue-raisers that would impose tax-compliance requirements on businesses and create a 2.5 percent excise tax on certain medical devices."

View a PDF of the Affordable Health Care for America Act.


What is your current top business concern? To vote in HomeCare's monthly Web poll, visit www.HomeCareMag.com.


TAHCS’ Johnson: Welcome to H.R. 3790
DALLAS--Just a few weeks after being introduced, the bill that would eliminate DMEPOS competitive bidding is gaining traction among legislators.

As of Friday, H.R. 3790, introduced on Oct. 13 by Rep. Kendrick Meek, D-Fla., had garnered 53 cosponsors.

"This places us over halfway to our goal of 100 cosponsors within only three weeks," said Barry Johnson, president of the Texas Alliance for Home Care Services and one of the bill's originators. "We expect more congressional support as members fully understand the tremendous cost savings of our budget-neutral legislation."

The goal, Johnson said, is to see the bill “signed and enacted on Jan. 1"--or the first business day after Jan. 1. “In the words of Larry the Cable Guy,” he said, “we need to get ’er done.”

With the Meek bill, providers are finally armed to fight the battle against competitive bidding, according to Johnson, who stressed that more providers are needed on the front lines. “We need more providers to step up to the plate and tell the story,” he said. “It’s an education process.”

He knows it’s tough for providers who have never been politically active before. Johnson said when he visits a legislator’s office, “I say, ‘I’m not here to bother you; I’m here to tell you something that is going to make everyone’s life better.’”

A respiratory therapist for 40 years, Johnson is a salesman when it comes to the Meek bill because he believes it gives CMS just what it wants and protects patients and providers at the same time. “The point of competitive bidding was to reduce the number of providers out there. Competition reduction. Well, OK,” said Johnson. “Reduce fraud and abuse--absolutely. Get more for your money. I’m a taxpayer and I’m all for that.

“But what if I could do all that stuff better, faster, quicker and give you back $25 million? Would you go for that? Well, welcome to H.R. 3790.”

Johnson ticked off the bill’s selling points:

Significant savings. “First off, we have a bill with a number on it. It’s pretty tough to see the light when no one turns the light bulb on,” Johnson said. Up to this point, industry representatives could only provide legislators with information and particulars about the devastating problems competitive bidding would create for small business providers and Medicare beneficiaries, he said.

“But how can they really properly evaluate what you are telling them? Now they have the legislation and they can see the legislation,” Johnson said. “We have had it scored by an independent actuary, and it’s coming in about 10 percent [savings for Medicare]. We’ve had a 9.5 percent cut already. That’s 19.5 percent, a half percent greater than the [savings from the] first round of demonstrations in Polk County, Fla.”

Combined with the 25 percent savings on oxygen from the 36-month oxygen cap implemented in January, Medicare is already seeing a substantial savings that is far beyond the average 26 percent savings on DMEPOS items in the aborted Round 1 of competitive bidding last year.

“We’re rolling back the prices to 1998. We’re better than Walmart,” Johnson said.

Access to care. The Meek bill would preserve patients’ access to care because it would not eliminate thousands of providers, Johnson pointed out. “When you’re reducing the number of providers by 90 percent, you are asking 10 percent of the providers to take care of 100 percent of the population. That’s a tough deal,” he said.

His own Dallas County is 9,000 square miles and, under competitive bidding, would have only about 40 providers, he estimates. “It’s going to be difficult to get from one corner to another in a timely manner … Now we have a patient risk issue here because we are limiting access to care.”

Medicare is very likely to see more trips to the emergency room and more hospitalizations because there will be too few providers to attend to them quickly, a problem that would worsen dramatically in cases of thunderstorms, hurricanes, snow and heavy winds, Johnson said.

Elimination of the Competitive Bidding Implementation Contractor. “The CBIC can go away, and the cost of the CBIC is $25 million annually,” Johnson said. "We truly have a bipartisan bill which will achieve the same results as competitive bidding while returning $25 million to the taxpayer annually. These administrative funds are simply being wasted to administer the severely flawed competitive bidding program."

Curb fraud and abuse. “We want to start a fraud-and-abuse program that works with the $25 million,” Johnson said. Because of mandatory accreditation, surety bonds, onsite visits, stiffer standards and post-payment audits, inroads are already being made into the fraud-and-abuse arena, he said.

“There was a reduction of providers, on average, of about 40 percent,” he said. “We think what has happened is that those people who were less than responsible, those people have dropped out.

“Congress is seeing that,” he continued, noting that despite the derogatory stories popping up all over the media--the most recent being a “60 Minutes” piece on Oct. 25 (see story this issue)--legislators are beginning to understand that most of the fraud that is surfacing is being perpetrated by “Nigerian scam artists and the Russian mob, not the majority of the independent mom-and-pop, dedicated providers” serving local areas.

“This is good news for our industry,” he said. “They know it’s not us.”

Johnson is hopeful that other organizations such as the AMA will get on board and help champion H.R. 3790 with legislators. Last week, the 5,000-member National Association for Support of Long Term Care threw its support behind the bill. The group is encouraging a grassroots effort and is sending an “advocacy message” to legislators through the NASL Advocacy Center.

Such support could help to make H.R. 3790 a standalone bill rather than one that would need to piggyback on another measure such as health reform legislation. “I personally would like to see it as an independent-status bill,” Johnson said. “There are too many problems associated with the health reform package.”

He’s proud of the Meek bill, which he noted was forged over seven months with important input from industry stakeholders and help from the American Association for Homecare. There’s much good in it, he believes. But in the end, the biggest reason to eliminate the DME bid program is “to save the beneficiary” because competitive bidding is unsafe for patients, Johnson said.

“Rather than go through this gyration with competitive bidding and all the problems associated with it, let’s just go with 3790 and make everybody happy,” he said. “It’s a way to save for the Medicare program. This is a bipartisan bill that does something for everybody.

“We’ve kept access, lowered the patients’ copay by reducing the fee schedules and, Grandma, we are not throwing you out with the bathwater … We do all that independently, with one swoop of the pen and without asking for any assistance from any government agency and no new taxes for any taxpayer.”

Johnson has a personal interest in all this that goes beyond his business. His father is 86 and needs oxygen. He does not want to see what happens to his dad if competitive bidding goes through.

Elimination of the program is “just something that has to happen,” he said. “We owe this to the American taxpayer, we certainly owe it to the beneficiary and we owe it to Congress to come up with a bill where we can continue to provide the services, protect the elderly and prevent fraud.

“If they can pass this bill, they will definitely be a Medicare beneficiary’s hero.”


To contact your representative in support of H.R. 3790, call the U.S. Capitol switchboard at 202/224-3121. The operator will connect you directly to your congressman’s office using your ZIP code.

Background and talking points for H.R. 3790 can be found here.

The full text of H.R. 3790 can be found here.


CMS has scheduled its eighth and final Special Open Door Forum on the Round 1 rebid Wednesday, Nov. 4, from 2 to 3 p.m. ET. To participate in the call, which will be devoted to questions about bidding, dial 800/837-1935 and reference Conference ID 23045924. As a reminder, Nov. 4 marks the close of bidding registration.


Providers Struggle with PECOS: 'We Have Zero Control'
ATLANTA--Jan. 4, 2010, is suddenly a very scary date for HME providers. That’s when Medicare will stop paying claims unless the referring physician is registered in the Medicare Provider Enrollment, Chain and Ownership System (PECOS). Problem is, many physicians are not registered and have little incentive to do so: They will continue to get paid by Medicare whether they are in the PECOS system or not.

The dilemma has surfaced as providers have begun to receive CEDI warnings on claims processed on or after Oct. 5 that would not pass muster come January. HME companies across the country report a large percentage of claims are currently getting such warnings, and they are realizing the onus is on them to convince their referring doctors to sign up in PECOS.

“I have heard from members who have 100 percent warnings on their claims,” said Rose Schafhauser, executive director of the seven-state Midwest Association for Medical Equipment Services. “Many are 80 percent.”

“As we approach doctors, most of them don't know about this or they don't think it applies to them,” said Terry Flatt, executive vice president of Hammer Medical, Des Moines, Iowa, which has 93 employees working in eight locations. “Physicians aren't aware of what to do and won't be impacted if they don't do anything. The [PECOS] database is not accurate, and there is a two-month lag before information shows up. We are going to run out of time before the Jan. 4 deadline. The fear of our industry is that, come Jan. 4, whether it's the doctor, the database or CMS, claims will stop being paid, and we have zero control.”

After doctors or other eligible referrers register in the online PECOS system, they submit a signed statement to their Medicare contractor certifying that the details they submitted in PECOS are true. The Medicare contractor then links the signed certification to the Web-based submission. If there is missing or incorrect information, the delay could take 60 days or longer.

Flatt said Hammer Medical has created a spreadsheet to analyze the extent of the problem. The provider recently received warnings with about 80 percent of claims, and the strategy is to approach larger physician groups first in order to have the most impact with the least effort. “We are being very proactive in educating our physicians,” he said.

“It's very wrong,” said Flatt. “We could be the ones not getting paid for service, and we don't have any control. It's very dysfunctional. We have considerable time and expense invested, and we are taking a proactive approach to protect our future. We have spent hundreds of man-hours and continue to do so educating the physicians and our referral sources. It is an area we have to address. We are running out of time.”

Many MAMES members have pulled billing staff off their regular duties to put them on the PECOS issue, said Schafhauser. MAMES is providing a “cheat sheet” to members on what they need to do to educate physicians, she said, but she wonders why the burden should fall on HME providers.

“What's unfair to them is when the physician's office says 'why are you bugging us about this?' We are being put in the middle,” Schafhauser said. “We are a small part of the Medicare budget, but we are having to turn into police officers.” The bottom-line cost of dealing with the problem is hard for members to wrap their arms around, Schafhauser added. “It involves staffing resources many companies don't have at this time.”

Schafhauser said one encouraging aspect is that the problem related to PECOS registration will also surface when, for example, a general practitioner refers a patient to a medical specialist; paying the specialist's claim will also require the general practitioner to be listed in PECOS. “I'm not sure why the [specialist] physicians' offices aren't screaming about it,” said Schafhauser. “Maybe they are and we're just not hearing about it.”

“I don't know how you deal with the impact it will have on the customer,” said Mary Rogers, billing manager of Jim's Home Health Supplies, Lincoln, Neb. “What do we tell a customer who comes in and needs something and their referring physician is not authorized to order it [and get it paid for by Medicare]? It's an industry-wide dilemma we are all going to have. The chances of getting 100 percent of physicians [in the system] is nil. It's not going to happen.”

Jim's serves a 50-mile radius around Lincoln, including many physicians in smaller communities. Educating them to the problem “will be very time-consuming,” said Rogers.

Rogers noted that Jim's was originally receiving warnings on 100 percent of its claims until it adjusted its internal system to report the doctor's name in all caps as required. Since then, warnings have been lowered to about 78 percent, she said.

The company is still investigating the problem and has compiled lists of doctors in various specialties from the PECOS database to compare with the company's own directories. “We're finding that, for example, one of our large internal medicine practices didn't have any physicians listed. We looked up the urology specialty and found only one urologist listed [in our area], but we have 18 urology physicians in our directory,” Rogers said.

“We polled about 100 doctors last week and only one had even heard of it,” said Chris Rice, director of marketing, Diamond Respiratory Care, Riverside, Calif., whose market includes about 2,500 physicians covering much of southern California.

Diamond Respiratory plans a marketing campaign to let doctors know about the program, including a pamphlet that covers how doctors should register. The provider also plans to enclose inserts with mailings. In cases when Diamond receives a warning, the company is faxing the specific doctor to explain the problem.

“They're telling us this is how it's going to be, so we have 60 days to get a whole lot of doctors into the system,” Rice said. “We have to take some kind of action.”

Added Rice, “I think [CMS] should delay it until we can make sure the doctors are in the system, and in the interim they should educate the doctors.”

“[PECOS] has turned into the No. 1 issue right now for providers,” said Schafhauser.

View MLN Matters Article MM6421 on the PECOS.
Free PECOS Extractor Tool
In an effort to simplify the identification of physicians not enrolled in the PECOS, ClaraVista has created software that parses the warning information from GenResponse reports for electronically filed claims. The PECOS Warning Extractor, or PWE, creates a work list in a .csv file format that can be accessed through Notepad or Excel, sorted, analyzed and distributed to staff members so they can contact physicians about enrolling in PECOS before Jan. 4, 2010.

"The PWE is not stunning; it will not make a programmer’s heart go pitter-patter," said ClaraVista's Derrick Stark. "We designed it to be simple to use so our clients could get their physician education initiatives off the ground quickly. Given the implications of not getting a jump on PECOS, we are making it available to all providers without charge."

To download the PWE tool, go to www.starkvistagroup.com.

A video tutorial on its use is available at www.youtube.com/watch?v=KBuQYnoyb6A.

For questions, contact ClaraVista at pecossupport@miravistallc.com or 803/253-8796, ext. 200.




Conference Moves Rehab Sector Forward on Separate Benefit
ST. LOUIS--Complex rehab stakeholders who gathered in St. Louis last week to talk about a separate complex rehab benefit left the all-day consensus conference with three main take-aways: It needs to be done, there is much work yet to do and it is doable.

That was good news for the Complex Rehab Steering Committee, which hosted the conference and got the green light from some 50 attendees to go ahead with efforts to redefine the complex rehab Medicare benefit.

“I would say the biggest message was, ‘You guys are on the right track.’ We had consensus that this is something we need to do,” said Don Clayback, executive director of the National Coalition for Assistive and Rehabilitation Technology Suppliers and a member of the steering committee.

The event offered stakeholders the opportunity to express their concerns and comment on the work of the steering committee and its work groups, which focused on such issues as fee schedule and coding, medical policy, claims processing and provider qualifications.

“We’re trying to flesh out the details through the industry so that we can put those details together into a plan to create a redefined benefit for complex rehab,” explained Tim Pederson, CEO of WestMed Rehab in Rapid City, S.D., and chair of the American Association for Homecare’s Complex Rehab and Mobility Council.

He added, “I don’t see us taking it out of the DMEPOS benefit.” Instead, he and Clayback said, a reconfigured benefit might look a lot like the orthotics and prosthetics benefit that falls under DMEPOS.

“They are under the DMEPOS category, but they have their own coverage criteria,” Clayback said.

One of the key issues of the day was the definition of complex rehab. “There is broad agreement on all the bullet points that define complex rehab; however, we have not been able to reach consensus in the industry on the wordsmithing of the definition,” Pederson said. “There was some division on the steering committee on whether we should focus on the technology for the definition or [on] the process,” he continued. “Is it the products or the process? What we determined is that it is both. We really can’t define one without the other. So we are going back to the drawing board and try again.”

Clayback said the definition would ultimately cover technology/products, users, the process and qualifications of people involved in the process.

Other discussion centered on how the industry can work with CMS and its contractors to change the regulatory arena and elevate the industry, Pederson said.

“There are certain items we are going to pursue through the regulatory process and certain items we are going to pursue through the legislative process,” he said. “One of the main things we can do with CMS is to develop a front-end mechanism that identifies a complex rehab supplier, which we don’t have right now.”

While quality standards require that a RESNA-certified ATP be involved in the wheelchair selection for a patient, Pederson said, “right now, there is no edit system in place to identify whether an ATP was involved.”

National Supplier Clearinghouse forms do not have any way to document that the provider is a complex rehab supplier, he noted. “It seems silly to have that requirement and not have a way to document it,” Pederson said.

Stakeholders are also concerned, he said, that the complex rehab provider qualifications and accreditation need “some teeth.”

“Even though we have quality standards, there is a degree of separation on the application of those standards, and among the surveyors, there are varying methods. We need a little more uniformity and a more robust process,” Pederson said.

As well, he noted, a RESNA registry of certified ATPs would be helpful. “We came up with recommendations for RESNA, the NSC, accreditation bodies and for the DME MACs that we can do now and they will immediately elevate our industry exponentially,” Pederson said.

Clayback said it was likely some issues would require legislative action. “So we are looking now toward legislation, identifying champions, doing more outreach to the consumer and clinician sides,” he said. “We are looking at probably a two-year project from legislation to implementation and operation. Some of the changes could go into effect in 2011.”

The conference was the fourth in a series of events sponsored by the steering committee--including two Webinars and a session at Medtrade--to gather feedback, and other Webinars are planned.

“The go-forward plan … is to pull all that together into a summary document with a proposed definition that people will be able to comment on,” Clayback said. “We will be creating kind of a white paper that will flesh out some of these details, and we will be sharing it with the industry and other groups through Webinars later this month.”

The goal of the steering committee, he stressed, is to be transparent in its work, to invite input from every stakeholder and to draft a plan that will generate consensus.

“I truly think there is going to be consensus in the industry,” said Julie Piriano, director of rehab industry affairs for Exeter, Pa.-based Quantum Rehab. “I’m really looking forward, once we get this defined, to looking for legislative champions to take the ball and run with it so we can fully effect change to this benefit.”


CMS Issues Final Rule on Oxygen Maintenance for 2010
BALTIMORE--In a late Friday list-serv message, CMS announced that the following final rule is on display at the Federal Register: “Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010.”

The new final rule includes rules on:

(1) maintenance and servicing of oxygen equipment;
(2) the establishment of a notification process for suppliers choosing to become grandfathered suppliers under the DMEPOS competitive bidding program; and
(3) payment for damages resulting from termination of contracts awarded in 2008 under Round 1.

The text of the message follows:

Maintenance and Servicing of Oxygen Equipment
New rules regarding payment and supplier responsibilities for maintenance and servicing of oxygen equipment have been established in accordance with Medicare Improvements for Patients and Providers Act (MIPPA) of 2008 requirements. The new maintenance and servicing rules permit payment every 6 months, beginning 6 months after the end of the 36-month rental payment cap, for maintenance and servicing of oxygen concentrators and transfilling equipment to ensure that the equipment is kept in good working order for the safety of the beneficiary. The new rules are effective for items furnished on or after July 1, 2010. The maintenance and servicing policy established for 2009 as part of an Interim Final Rule (73 FR 69726) will continue for items furnished through June 30, 2010.

Beginning July 1, 2010, a single maintenance and servicing payment of $66 may be made once every 6 months for maintenance and servicing of an oxygen concentrator (stationary or portable) and, if applicable, oxygen transfilling equipment. Separate payment is not made for each piece of equipment serviced. The maintenance and servicing payment does not apply to liquid or gaseous oxygen equipment (stationary or portable). The maintenance and servicing fee covers all maintenance and servicing needed during the 6-month period. The supplier is responsible for performing all necessary maintenance, servicing and repair of the equipment at the time it is needed and must also visit the beneficiary’s home during the first month of each 6-month period to inspect the equipment and perform any necessary maintenance and servicing needed at the time of each visit.

CMS will issue program guidance with specific information for claims processing and beneficiary education over the next few months.

Grandfathering Notification Process
A process has been established for suppliers that are not awarded contracts under the DMEPOS Competitive Bidding Program to provide notification of their decisions regarding whether they will continue furnishing rented durable medical equipment (DME) and/or oxygen and oxygen equipment as grandfathered suppliers under the program. This process requires noncontract suppliers to provide written notification of their grandfathering decisions to CMS and all Medicare beneficiaries who reside in a competitive bidding area to whom they are furnishing these items. The process also requires beneficiaries to notify grandfathered suppliers regarding whether they wish to continue receiving their items from a grandfathered supplier.

The regulation also establishes a requirement that there be coordination between contract and noncontract suppliers regarding the removal and delivery of medically necessary items to and from a beneficiary’s home. Noncontract and contract suppliers are required to work together to ensure that DMEPOS services are uninterrupted. A grandfathered item is defined in the regulation to encompass all oxygen and oxygen equipment or all rented DME within a product category other than oxygen and oxygen equipment. Therefore, if a supplier chooses to become a grandfathered supplier for oxygen and oxygen equipment, it must continue to furnish all items of oxygen and oxygen equipment to all beneficiaries who choose to continue receiving the items from the grandfathered supplier. Likewise, if a supplier chooses to become a grandfathered supplier for an item of rented DME in a given product category, it must continue to furnish all rented DME in the product category to all beneficiaries who choose to continue receiving the items from the grandfathered supplier.

Process for Considering Claims for Damages
MIPPA terminated contracts awarded under Round 1 of the Medicare DMEPOS Competitive Bidding Program and stipulated that, to the extent that any damages may be applicable as a result of the termination of contracts, such damages shall be payable from the Federal Supplementary Medical Insurance Trust Fund.

In accordance with the final regulation, claims for damages may only be filed by suppliers that submitted a bid and were awarded a contract in 2008 during Round 1 of the program. Any damages that are claimed must be substantiated and must be the direct result of termination of a contract under Round 1 of the program. The extent of the obligation for payment of damages is limited to damages realized by the contract supplier. Therefore, entities that entered into subcontracting relationships with a contract supplier for purposes related to furnishing items and services under the program are not eligible to submit claims for damages.

The Competitive Bidding Implementation Contractor (CBIC) will be the intake point for claims for damages, which will be reviewed by the CBIC and CMS. Claims must comply with all requirements specified in the final regulations. The CBIC will accept claims that are submitted by April 1, 2010. The date of submission is the actual date of receipt of the completed claim by the CBIC. No claims for damages will be accepted if they are received by the CBIC after April 1, 2010. If a claim for damages is not submitted by the deadline, the CBIC will recommend to CMS not to process the claim any further.

Claims for damages must be submitted in writing to the following address (electronic submissions via e-mail or facsimile will not be accepted):

Competitive Bidding Implementation Contractor
2743 Perimeter Pkwy., Ste. 200-400
Augusta, Georgia 30909-6499

Every effort will be made to make a determination within 120 days of initial receipt of a claim or the receipt of additional information, whichever is later. However, in the case of more complex cases, or in the event that a large volume of claims is submitted, it may take more than 120 days to process a claim.

The final rule can be viewed at federalregister.gov/page2.aspx.

'60 Minutes' Points TV Finger at Medicare Fraud
ATLANTA--The media heat is back on. This time it is the venerable television news magazine "60 Minutes," which ran a segment on Oct. 25 focusing on DME fraud in South Florida and Los Angeles. But this time there's also a twist, industry proponents say: The finger of blame points at Medicare for not stopping it.

Complete with a recently convicted criminal named "Tony" in disguise, the 15-minute vignette ended with this memorable exchange in reference to equipment suppliers in South Florida:

Commentator Steve Kroft: "If I went to the phone book and looked under medical equipment suppliers, 95 percent of the companies would be phony?"

Convicted criminal: "Yes, sir."


Reaction to the story ranged from outrage to relief that the focus was largely on obvious criminals who never had an interest in serving patients.

"This story, while not reflecting very well on suppliers, did not show a legitimate supplier who was committing fraud, only crooks who entered the business solely to make easy money," said Wayne Stanfield, president and CEO of the National Association of Independent Medical Equipment Suppliers. "Only CMS can end the fraud by holding contractors accountable for their actions and making significant changes to the inspection and oversight process for suppliers."

"I've already had a couple conversations with the people at '60 Minutes' to straighten out some of the misleading statements made in that piece, which chiefly focused on the failure of Medicare to keep criminals out of the business," said Michael Reinemer, vice president, communications and policy, for the American Association for Homecare.

"AAHomecare has been all over the fraud issue for many years. We've worked hard to get out in front in the media and on Capitol Hill with our own 13-point anti-fraud plan.

"To frame this story," Reinemer continued, "it's worth noting that [AAHomecare President] Tyler Wilson has been on the Fox Business channel discussing our efforts to stop fraud. One of our board members, Joel Marx, spent 30 minutes on C-SPAN talking about the value of home care last month. AAHomecare was quoted on the front page of USA Today saying that the federal government has done a terrible job of keeping criminals out of Medicare."

On the positive side, provider Tim Pederson pointed out that the story exposed problems with CMS and supplier numbers.

"I think the AAHomecare 13-point plan would address many of these issues," said Pederson, CEO of WestMed Rehab, Rapid City, S.D. "When I compare my last [National Supplier Clearinghouse] site visit to the complete lack of oversight documented on the news story, I can only shrug. When the NSC came to my business, they did so unannounced, and they conducted a thorough evaluation complete with pictures and a review of medical records and inventory.

"Instead of focusing on catching the real criminals, CMS continues to spend resources to make it more difficult for legitimate providers to conduct business," added Pederson. "The real criminals don't care how difficult it is for legitimate suppliers because, rather than provide services to beneficiaries, they merely send a bill to Medicare for items not provided. In this day and age, the existence of these crime rings is unacceptable."

With CMS and law enforcement officials expressing exasperation on camera, it only begged the question: Why not do what industry advocates have been suggesting for years?

"We as an industry have been trying to raise the barriers to entry for years, and we have laid out points to CMS regarding the so called pay-and-chase policy," said Tom Ryan, president and CEO of Homecare Concepts, Farmingdale, NY. "We have said to do site visits on any new provider before a number is given, but make sure the NSC contracted agent knows what to look for. We have suggested prepay audits on new providers, and certainly the ability to data mine real-time to see these aberrations of going from $30,000 one month to $800,000 the next month — these would set off some red flags to freeze payment and audit the claims."

Indeed, AAHomecare has put its 13-point plan to curb fraud in front of Congress several times, once in 2008, again in February this year, and again yesterday with a statement applauding Health and Human Services Deputy Secretary William Corr's statement to the Senate Judiciary Committee that the federal government is committed to "stop fraud before it happens."

"The association has zero tolerance for fraud and remains committed to eliminating fraud and abuse in the Medicare program. We are eager to work with Congress, the White House, the Centers for Medicare and Medicaid Services (CMS), and federal law enforcement agencies in efforts to ensure the integrity of the Medicare program. To that end, we continue to offer suggestions for additional fraud and abuse prevention strategies over and above existing laws," AAHomecare said.

"Our legislative action plan is designed to protect these patients and their families--as well as the American taxpayers--by stopping fraud and abuse in the Medicare system at the front end of the payment system rather than after the fact. The plan targets fraud and abuse at the source through proposed policies that will ensure that providers who participate in Medicare are legitimate businesses and that disreputable actors are locked out of the system. Among the provisions detailed in the legislative proposal are more rigorous quality standards, increased penalties for fraud, mandated site inspections for new providers, and real-time claims analysis."

The 13 specific recommendations in the plan include:

1) Mandate Site Inspections for All New Home Medical Equipment Providers. A July 2008 GAO report underscored the need for CMS to ensure that its contractors are conducting effective site inspections for all new applicants for a Medicare provider number.

2) Require Site Inspections for All HME Provider Renewals. All renewal applications should require an in-person visit by the National Supplier Clearinghouse (NSC), the contractor that CMS uses to ensure integrity in the Medicare program.

3) Improve Validation of New Homecare Providers. Additional validation of new providers should be included in a comprehensive and effective application process for obtaining a Medicare provider number.

4) Require Two Additional Random, Unannounced Site Visits for All New Providers. Two unannounced site visits should be conducted by NSC during the first year of operation for new HME providers.

5) Require a Six-Month Trial Period for New Providers. The NSC should issue a provisional, non-permanent supplier number to new suppliers for a six-month trial period. After six months of demonstrated compliance, the provider would receive a "regular" supplier number.

6) Establish an Anti-Fraud Office at Medicare. CMS should establish an office with the sole mandate of coordinating detection and deterrence of fraud and improper payments across the Medicare and Medicaid programs.

7) Ensure Proper Federal Funding for Fraud Prevention. Increase federal funding to ensure that NSC completes site inspection and other anti-fraud measures.

8) Require Post-Payment Audit Reviews for All New Providers. Medicare's program safeguard contractors should conduct post-payment sample reviews for six months' worth of claims submitted to Medicare by new providers.

9) Conduct Real-Time Claims Analysis and a Refocus on Audit Resources. Medicare must analyze billings of new and existing providers in real time to identify aberrant billing patterns more quickly.

10) Ensure All Providers Are Qualified to Offer the Services They Bill. A cross-check system within Medicare databases should ensure that home care providers are qualified and accredited for the specific equipment and services for which they are billing.

11) Establish Due Process Procedures for Providers. CMS should develop written due process procedures for the Medicare provider number process, including issuance, denial and revocation of the Medicare supplier number. The procedures must include, for example, an administrative appeals process and timelines.

12) Increase Penalties and Fines for Fraud. Congress should establish more severe penalties for instances of buying or stealing beneficiaries' Medicare numbers or physicians' provider numbers that may be used to defraud the government.

13) Establish More Rigorous Quality Standards. Ensure that all accrediting bodies are applying the same set of rigorous standards and degree of inspection to their clients.

According to Reinemer, "The key thing is for every HME provider and every state association to get involved and work with their local media. There is no silver bullet that is going to make this story go away since we can't fix the fraud problem--Medicare has to do that. It's going to require real work for a sustained period by everyone in the HME sector."

Reinemer noted the association's ongoing Stand Up for Homecare PR offensive. "We are trying to make it easy for everyone to pitch in to get accurate media coverage for home care," he said.

Check out the "60 Minutes" story.

Read AAHomecare's response to "60 Minutes."

For more information on the Stand Up for Homecare campaign, see www.aahomecare.org/standupforhomecare.

To report Medicare fraud, the Office of the Inspector General maintains a confidential hotline:
Phone: 800/HHS-TIPS (800/447-8477)
Fax: 800/223-8164
Email: HHSTips@oig.hhs.gov
Mail: Office of the Inspector General, HHS TIPS Hotline, P.O. Box 23489, Washington, DC 20026


VGM Debuts FEAT Web Site
WATERLOO, Iowa--The VGM Group has launched a new Web site for the Fraud Eradication Advisory Team (FEAT), which was formed in conjunction with a group of industry stakeholders "as an effort to maintain an ethical society within the home health care industry," the member services group said.

FEAT will operate as a sounding board for all stakeholders including state associations, advocacy groups, manufacturers, providers and beneficiaries to assist CMS in fighting fraud and abuse, VGM said. To aid in the fight, the FEAT Web site offers an electronic, user-friendly reporting tool to convey information about suspected fraud or abuse of the Medicare program.

More information about FEAT can be found at www.mymedicarefraudreporting.com.




Q&A: Here We Go Again--Competitive Bidding, Part II
AMARILLO, Texas—According to health care attorney Jeff Baird, the HME industry continues to be buffeted by “the Perfect Storm, a convergence of regulatory restrictions, reimbursement cuts and our old nemesis competitive bidding.” In the following Q&A covering some of the most common questions about the DMEPOS bid program reprise, Baird points out that the upcoming Round 1 rebid does not affect only the initial competitive bidding areas. “The first round will affect all HME suppliers, regardless of where they are located,” said Baird. “It is critical that the industry work as a team to defeat this ill-conceived program. Hopefully, competitive bidding will be rescinded before it goes into full effect. However, for now, the suppliers in the first nine CBAs must deal with it.”

Q: Unfortunately, I am located in one of the first nine competitive bid areas. I understand that in my application process, I have to estimate my “capacity.” What does this mean?
A: The request for bid (RFB) instructions direct suppliers to estimate their capacity by calculating the number of units they currently furnish on a yearly basis and adding any additional units they will be capable of furnishing during the first year of the contract period. Bidders must report their estimated capacity on the bid form.

Q: Does CMS have to accept the estimated capacity that I submit?
A: No. CMS may adjust a bidder’s reported capacity if it is above the supplier’s historic capacity and the supplier’s expansion plan or financial scoring does not allow CMS to be confident that the supplier can operate at a sufficient level on Day 1 of the contract period.

Q: I am located in a small town in the Midwest. My town should never be included in a CBA. Why should I be concerned about competitive bidding? From a practical standpoint, doesn’t competitive bidding only affect suppliers in the larger cities?
A: Essentially, the whole country--not just those cities that make up the first nine CBAs--will be affected by Round 1. Let me explain. The recent Senate Finance Committee health care reform proposal “Chairman’s Mark” would require expansion of the number of areas to be included in Round 2 from 79 of the largest MSAs to 100 of the largest MSAs by including the next 21 largest MSAs by population.

The Chairman’s Mark would also require that HHS extend the competitive acquisition program, or the competitive bid rates, to the rest of the country by 2016. It is likely that the starting point for Round 2 bidders will be the rates established in Round 1. If the language in the Chairman’s Mark finds its way into the final health reform bill, then suppliers in small-town America will be directly affected by what happens in the first two rounds.

Q: I keep hearing about a legislative bill that will repeal competitive bidding. Does such a bill exist and, if so, what does it say?
A: Recently, Rep. Kendrick Meek, D-Fla., introduced H.R. 3790, a budget-neutral competitive bidding repeal bill. This pay-for competitive bidding repeal would eliminate the CPI-U updates for all DME in 2010, 2011, and 2012; in addition, the DME fee schedule would be reduced by 0.25 percent in each of these three years. In 2013, all DME would receive a CPI-U update. In 2015, complex rehabilitative power wheelchairs, recognized by HHS as classified within group 3 or higher, would receive a CPI-U update. All other DME would receive no CPI-U update, as well as a 0.5 percent reduction in fee schedule payments.

According to industry insiders, the Office of Management and Budget has scored the proposal as being budget-neutral. In reaching this score, OMB assumes that future competitive bidding savings will be approximately 10 percent (after the 9.5 percent cut).

Q: As I prepare my bid, how careful should I be in meeting state licensure requirements?
A: Very careful. Suppliers submitting a bid for a product category in a CBA must meet all DMEPOS state licensure requirements, if any, for that product category for every state in that CBA.

Prior to submitting a bid in a CBA, the supplier must have a copy of the applicable state licenses on file with the NSC. CMS will verify with the NSC that the supplier has all such licenses on file. In order to be eligible to be awarded a contract, suppliers must possess the applicable licenses at the time of bid submission for each location listed on Form A of the online bid submission system (“DBidS”).

Contract suppliers must maintain compliance with all licensure requirements throughout the duration of the contract period. A supplier with only one location in a multiple-state CBA must have that location meet the licensure requirements of each state in the CBA to provide competitive bidding items and services throughout the CBA. Each location of a supplier with more than one location in a multiple-state CBA must have the applicable state licenses for the state in the CBA in which it provides the competitive bidding items. Each location does not have to be licensed for both states unless that location is providing items in both states.

Q: I keep hearing that my bid must be “bona fide.” What does that mean?
A: The CBIC will use statistical measures to screen for non-bona fide (or unrealistic) bids. If a bid is suspected as being non-bona fide, then the CBIC will contact the bidder. The bidder must prove that the bidder can furnish the item at the bid price. Such proof may include, but is not limited to, a manufacturer’s invoice for the item.

CMS has stated: “We may ask the bidder to give us additional information to make sure that the bidder can actually furnish the item at the bid price. When we contact a bidder about a potentially non-bona fide bid, it is the bidder’s responsibility to provide sufficient information to prove that it can furnish the item at the bid price. This should include, at a minimum, a brief description of the rationale for the bid, along with financial documentation to support the rationale.” If the amount for one item in a product category is found to be not “bona fide,” then that bid for that category will be disqualified.

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 an answer from health law firm Brown & Fortunato. (No names will be used if your question is published.)


Sleep Titans Team Up on Education for PCPs
SAN DIEGO, Calif., and MURRYSVILLE, Pa.--ResMed and Philips Respironics put aside their friendly competition last week just long enough to publicize a joint effort to boost sleep apnea education and awareness in the medical community. Shelving the quest for market share (at least for a day), the two titans of sleep medicine announced in an Oct. 27 press briefing they are joining forces to lend support and funding to educate primary care physicians about untreated sleep apnea.

According to the manufacturers, research in the last five years has changed the field of sleep medicine. With approximately one in five U.S. adults suffering from mild obstructive sleep apnea and roughly 90 percent believed to be undiagnosed, along with mounting scientific evidence of comorbidities such as diabetes, obesity and cardiovascular disease, sleep apnea is a growing public health issue.

In August, findings from one of the largest and most comprehensive multicenter studies, the Sleep Heart Health Study, demonstrated an increased risk of mortality in moderate to severe sleep apnea when untreated, raising the death risk 46 percent. Because it is such an important issue, the two sleep market leaders said they have joined together in the effort to improve the medical community's understanding through continuing medical education and outreach.

Beginning this month, live programs on the subject are being offered through two independent primary care education providers, Primary Care Network and Pri-Med Institute, in 17 cities across the United States. Organizers said it is the first time sleep apnea is being presented as a standalone topic during the typical one- to two-day seminars. The goal is to educate 7,200 clinicians by June 2010.

In the programs, primary care, family practice, internal medicine doctors, nurse practitioners and physician assistants will learn about symptoms of sleep apnea, screening implementation, diagnostic pathways, therapy and the latest research on the association of mortality and morbidity with untreated sleep apnea. They can also earn 1.25 CME credits for each program.

In the first five sessions earlier this month, close to 2,000 participants joined to learn more about sleep apnea, company officials said. Barbara Phillips, MD, MSPH, professor of Pulmonary Medicine, Critical Care and Sleep Medicine, University of Kentucky College of Medicine, who led a Pri-Med seminar Oct. 15-16 in Charlotte, N.C., noted in a release on the program that "the questions posed by the audience indicated a high degree of interest and involvement in the care of patients with sleep apnea. It is gratifying to see this level of interest."

"This combined effort will help tackle the challenges the industry faces in providing sleep apnea education to primary care providers," explained Ann Tisthammer, vice president, clinical education, Americas, ResMed. "Because sleep apnea diagnosis and treatment does not receive the sense of urgency it should in their practice, we believe supporting the CME programs will raise the level of awareness."

Tisthammer said the seminars are ideal for physicians to learn more about the relationship between sleep apnea and comorbidities. "If we take a look at the sleep apnea prevalence data with various comorbidities, we see some pretty significant associations," she said. "Eighty percent of drug-resistant hypertension patients have sleep apnea. Seventy-seven percent of obese patients have sleep apnea, and we have a 26 percent obesity rate in the United States."

JC Kyrillos, ResMed's senior vice president, sales, marketing and clinical education, Americas, told health reporters that educational grants to Primary Care and Pri-Med ensure excellence and fairness. According to Kyrillos, implementing the program through "grants with independent organizations that can drive CMEs" assured that the educators would not be "influenced by either manufacturer."

Officials from both companies believe that one of the simplest ways to increase awareness and identify the millions of unidentified patients with sleep apnea is to educate front-line physicians. Eoghan O'Lionaird, senior vice president and general manager-sleep for Philips Home Healthcare Solutions, noted that, until recently, medical schools have not prepared physicians for the challenge of undiagnosed sleep apnea. "The research in the last five years alone has changed the field of sleep medicine and our understanding of its impact and consequences," said O'Lionaird. "CME is a great forum to increase the knowledge of physicians on a condition and its therapy."

But if utilization ultimately goes way up, will payers push back? Kyrillos doesn't think so. "We think many payers are realizing that by treating sleep apnea, you are actually treating the related comorbidities," he said. "As a result, you are going to have better health care outcomes and lower overall costs."

In a Q&A during the briefing, Tracy Nasca, founder and senior vice president of Talk About Sleep, pointed out that diabetes education is usually reimbursable, but what about sleep education? Tisthammer responded that both companies are involved with the American College of Chest Physicians to carve out a sleep apnea educator role, and there are distinct possibilities for going down that road if proper certifications can be agreed upon.

Both Nasca and Barbara Rogers, president and CEO of the National Emphysema/COPD Association, commented that the educational effort in the physician community is both needed and welcome.

Sleep education and awareness have been a central focus for ResMed and Philips Respironics, the manufacturers said. Both companies also will continue to support the ACCP Sleep Institute program with half-day CME programs to be held across the United States. That program educates 300 to 500 physicians annually.

Check www.primarycareed.com or www.pri-med.com for information on the sessions and a schedule of cities and dates.


HME Expo Discontinued
ATLANTA--Organizers of the HME Exposition & Conference have announced plans to discontinue the event immediately.

"With the economy and our industry struggling, it is not necessary to develop an additional event in this industry," said Cory Smith, vice president of marketing for Access Business Media.

"Continuing another trade show in this economy does not make sense," commented Kevin Bird, the company's vice president of sales. "In addition to the difficulty in gaining traction with a new event in these economic conditions, Medtrade and Medtrade Spring are in [a] better position to serve the industry's needs.

"We thank all of the companies that exhibited with us in our 2009 event as well as all of the speakers, providers and industry veterans who helped us make our vision a reality. We now urge these same people to support the existing events and associations, including Medtrade and Medtrade Spring," continued Bird.

"Although this turned out to be an inopportune time for our new event, the fundamental value of a trade show/face-to-face event has not changed. This industry has been through a lot, and I know with the leadership at the American Association for Homecare and Medtrade, it will be able to weather this storm as well."


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



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