By Chris Calderone, MA, MBA Lean thinking is a quality improvement concept that was refined and perfected by Toyota in order to help increase quality and efficiency within their production system. Lean concepts focus on process efficiency, workflow optimization, waste reduction, workspace organization, and customer satisfaction. Hospitals and other healthcare businesses took notice of Toyota’s world-class quality and production success. Many healthcare businesses have started to successfully implement lean programs of their own. HME providers can learn valuable lessons by looking to other healthcare businesses and adapting some of the same lean princi-ples. In short, lean concepts and lean tools can help HME providers reduce the hid-den costs of inefficient processes while improving customer satisfaction. A few key concepts of lean thinking that could benefit HME providers include work standardization practices, error proofing tools, lean process flow design, and work visualization techniques – all are intended to help improve quality, reduce costs, and allow providers to become more responsive to the needs of their customers. For HME providers, work standardization means that you strive to formalize the informal within a work process such as intake. For example, providing clearly writ-ten, updated standard work procedures for specific payers and general intake proce-dures can help to reduce variation in results – variation which often shows up too late downstream in the form of an unsatisfied customer - or in the form of a rejected or delayed claim. Standardized work practices can help providers approach their work in a more planned, pre-defined manner. This approach will improve process consistency and improve overall process flow. Role clarification and task assignments should also be formalized along with the standardization approach. Standardization can also help to reduce the workaround culture that is present in so many systems and processes. Error proofing techniques can help make it difficult for staff to make mistakes. An example of an error proofing application could involve using decision guides or easy-to-use electronic decision algorithms that can help intake staff determine appropriate oxygen delivery models. This type of application was used with a large HME pro-vider, and it resulted in a decrease in the amount of costly rework involved in having to pick-up inappropriate oxygen systems and re-delivering more appropriate oxygen systems. Error proofing techniques can provide staff with near real time decision-making guidance that can help minimize expensive and wasteful rework; they can

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Lean Thinking

for HME

Emergency Events and

Annual Drills

Collection Calls

CMS and The NCD Process

Also of Interest

August R3

eConferences

eConference Suites

August 2008 Volume 5 Number 8

Reimbursem

ent and Regulatory Resources

WHAT IS LEAN THINKING AND HOW CAN IT HELP HME PROVIDERS

also allow for faster response times to referrals and patients. Another example of an error proofing application can be found in how providers utilize and lever-age their software. For example, a mid-sized pro-vider implemented payer-specific order templates for patients that received grouped supplies for specific order types such as trach orders and oxygen orders. Using the payer–specific tem-plates took the guess work out of trying to deter-mine correct quantity limits and covered vs. non-covered status based on payer-specific guide-lines. When the user selected the correct payer-specific template, the delivery ticket automatically populates with the correct items, correct quantity and correct billing vs. non-billing status – all based on that particular payer’s guidelines. This example of error proofing through leveraging software resulted in a significant decrease in or-der processing time, rework, referral/patient com-plaints, and pending revenue. Process efficiency or workflow optimization be-gins with clearly understanding how the current process works. Using a technique called value stream mapping, staff and leadership will be bet-ter able to “see” and understand their core busi-ness processes such as intake, billing and reim-bursement, and distribution processes. Gaining an in-depth understanding of the as-is process is crucial to being able to design a better, more “lean” process. Increasing the visualization of an HME process can help staff uncover waste in the form of excessive rework loops, lengthy wait times and process times, and low first-time-quality within the process. Optimizing workflow means that processes are designed to minimize other non-value added tasks such as handoffs and lengthy lead times. For example, a lean process in the intake area may involve merging separate intake tasks with insurance and documentation tasks. Another ef-fective way to optimize a process is by increasing the level of cross-training provided to the people that work within a process. Cross-training staff can result in a smoother process flow and en-

(Continued from page 1) hanced work leveling because leaders will have

more flexibility to redeploy and adjust workers as operational needs change. Minimal use of paper can also help to create a more lean process. Transferring information to other areas of the business should be done elec-tronically as much as possible to minimize paper handoffs. Paper handoffs are often followed by lengthy processing wait times. Lean processes often allow for communication within software systems or via e-mail alerts to other areas of the business. Optimizing workflow also involves having solid process-related metrics in place in order to moni-tor work status and work progress at key steps within the process. Process metrics include wait times, process times, lead times, and first-time-quality – which is a measure of how often work moves through a process step without requiring rework. Work visualization, which includes a concept called 5S, involves creating a more organized, visual workplace. 5S stands for five Japanese words that have been roughly translated into sort, set in order, shine, standardize, and sustain. 5S is a concept that incorporates principles of cleanliness, physical workflow design, and over-all workplace organization. The warehouse is a perfect area for implementing the 5S concept. 5S also involves the use of highly visible, easy-to-read labels, locators, and identification of work boundaries. One of the goals of creating a 5S workspace is to give nearly anyone the ability to walk through a workspace and be able to gain a basic understanding of how work moves through the area. 5S is a form of “visual sense making” that helps people to understand flow, work status, and work organization. In an example of 5S in action, a mid-sized pro-vider implemented improved product and shelf labeling, coupled with a redesigned shipping QA procedure – and they also redesigned the ware-house flow. The result was a decrease in the number of shipping/picking errors. Staff produc-tivity also increased. Businesses that have imple-mented a robust 5S program have achieved im-

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proved quality, improved safety, and improved productivity. Lean thinking concepts can be applied to any businesses- especially to healthcare businesses. HME providers can also benefit from lean appli-cations because HME providers, like a majority of business, deliver their services and products to their customers through a series of processes, not departments. Providers that take the time to learn about lean techniques and implement lean concepts into their operations will be better positioned to under-stand, manage, and improve their core business processes. Lean concepts can help HME provid-ers achieve and sustain long-term efficiency gains.

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By Vianna Zimbel, BS, RCP

Flooding through the mid-west this summer is a reminder that you need an emergency manage-ment process. Preparing for a disaster or local-ized emergency is a uniform requirement of the CMS Quality Standards for HME providers; thus, it is a requirement from all accreditation organiza-tions too. The Product Safety portion of the CMS Quality Standards state: The supplier shall:

Have a contingency plan that enables it to respond to emergencies and disasters or to have arrangements with alternative suppliers in the event that the supplier cannot service its own customers as the result of an emergency or disaster.

Pay attention to that new caveat tucked into the above sentence about having arrangements with alternative suppliers. Don’t be blindsided when your accreditation surveyor asks about what relationships you have established in the event of an emergency. Some companies al-ready work with their local fire department be-cause the HME fills their cylinders; other HMEs are owned by hospitals that are conducting an-nual mock-disaster drills, while most HMEs con-tact a friendly competitor across the river or bridge and agree to take care of each other’s clients if necessary. You do not need to have signed contracts, a ‘gentleman’s handshake’ with other similar providers in your geographic region is sufficient. You are doing them a favor too, since the relationship is probably reciprocal. Another accreditor requirement with which you must be able to demonstrate compliance is im-plementing your plan once a year. The accredi-tors will not accept a ‘tabletop’ drill. You need to either run an annual drill or actually have an event response at least once a year. The Home

Medical Equipment industry is resilient and like the Postman, ‘neither rain nor sleet nor snow- the job has got to go.’ We get the job done. Here is where most businesses over-think the emer-gency plan implementation process. It doesn’t have to be a major disaster. The event doesn’t have to be at your home office community; it can be anywhere in the region your business oper-ates. When the geographic area served by your company has heavy rain, flooding, a windstorm, power or phone outage, heavy snowstorm, tor-nado, forest fire, highway closure —realize you are implementing your emergency plan. Your staff probably contacts customers to inquire whether they need accelerated deliveries or can wait. You should have alternative methods for contacting staff, obtaining additional supplies, and accessing data from your computer if elec-tricity fails. When you’ve gotten past the event, write a brief review of what worked and what needs modifying for next time (if anything). It might be as simple as adjusting your plan to keep flashlights on site. Repeat your post-drill critique, doing this every time there is some hitch in the daily routine so you can keep resetting the clock for your annual test of the plan. A respiratory company with life-support ventila-tors will need an emergency plan with more detail and contingency components than a custom seating and mobility provider. However, regard-less of rehab or oxygen, you are required by both CMS and accreditors to have a written emer-gency plan that includes relationships with alter-native providers. If you don’t provide respiratory products, your plan may focus on business conti-nuity (information technology back-up and substi-tute access to that database about your patients and business). Although you hope never to have a disaster or to at least have forewarning of a weather-related event, your plan should address how you are going to know which customers are depending on your company for services and support, and how acuity is assessed for these patients so you can prioritize who gets first re-sponse.

EMERGENCY EVENTS AND ANNUAL DRILLS

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Collection Issues

By Keith Lilek, President & CEO, A/R Alle-giance

Here’s an interesting perspective. Have you ever thought about what happens to your accounts once you assign them to a collec-tion agency or attorney? How do most collec-tion agencies operate and how do they view collecting from your patients? Much of this relationship goes unnoticed by most of us because we are just happy to rid ourselves of the problem accounts. But the action taken by third party collectors on your behalf pre-sents an interesting and sometimes complex set of variables you may not have consid-ered. Let’s start here. Keep in mind that when un-paid patient accounts have been assigned: • The patients have ignored all of your col-

lection efforts • Collectors generally do not receive the

account until it has aged approx. 6 months

• Therefore, these patients have been given every opportunity to voluntarily re-solve their debt

Upon completion of your internal efforts, un-responsive patients are generally written off at this time. Phone Collection fees average 35% to 50%. The collector will only get paid if they get cash payments, so they have a vested interest in continual pursuit. Once collectors receive the accounts, the following steps take place:

1. Validation of debt letter. The first step in the process is informing the patient in writing that the account has now been assigned to a third party. This letter usually notifies the pa-tient that they have 30 days to dispute the charges. If they do not, the debt is now valid. 2. The first call. The purpose of the first call is to get the patient to react in some way. It occurs usually after a brief 10 day period to give the patient time to absorb the first let-ter’s message. The collector has to make the patient believe the time for payments and stalling tactics is over. In most cases, the collector will ask for full and immediate reso-lution of the debt, usually within 7 days. Gen-erally, this is non-negotiable and discussions at this point are rather limited. Collectors believe you want your money now and do not want the patient to think they have someone to run and complain to. Each patient is given the collector’s address and phone number. These calls are quick and to the point. There is a psychological impact achieved when the collector stays in control of the conversation. If a copy of an invoice is requested, it must be provided immediately. If a complaint is going to occur, it will most likely be from this call. Collectors want all patient calls to you to be referred back to them. No exceptions. The patient must be told it is out of your hands. It’s to your benefit that you comply with this policy. It is common for patients to turn to the creditor in the course of collection efforts in a further attempt to stall. Promises of payment

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COLLECTION CALLS FROM THE OTHER SIDE Ever wonder what collection agency and attorney collectors do and why?

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and claims of alleged harassment are among the reasons given by hardcore patients who wish to avoid their obligation to you, the creditor. Decep-tion is often used to drive a wedge between the collector and you to paralyze the collection proc-ess. By simply stating, “I’m sorry, but your account has been referred to our collector. You will have to work directly with them now to settle this mat-ter,” you can help effect payment and increase your recovery. You have extended your customer every goodwill to make restitution – you can no longer afford to believe any more excuses. The collector will occasionally request additional information from you at this time to verify certain things that they are being told. 3. The second call. This is made 7 days later if no payment has been received. The collector will now be dealing with the patient’s possible anger about the bill. At this point, the collector tries to negotiate a concrete payment arrangement. This demand never generates a complaint. If the pa-tient does not negotiate a payment, the collec-tor’s only other alternative is to tell the patient the account will be “finalized and further action will be taken (possible suit assignment). The patient is given a maximum of 7 days to respond. 4. The third call. The third attempt is where the collector is left with finding out what the patient is willing to offer. During this call, the collector will be able to determine the patient’s real intent to pay. Other calls may occur depending on various promises from the patient throughout this proc-ess. Generally, the collectors will work an ac-count for 4 months. If no suitable arrangements have been made, the account will be closed. I always suggest getting a secondary collection agency where this process will be continued with a renewed enthusiasm. Uncollected accounts can be reported to the credit bureau. About one in five collection agencies report. Many collection agencies prefer to avoid potential patient com-plaints by not reporting.

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Understanding this process will make your job much easier. Convincing people to pay who don’t want to can involve many complexities. So the next time an assigned patient calls you to swing a deal, remember this analogy. Simply put, if the collector is the “Dad” and you are the “Mom” and the patient is the “Child,” when the child is scolded by Dad and then tells Mom - if Mom sides with the child against Dad- the child (patient) wins. As in all successful relationships, when Mom supports Dad, the child has nowhere else to run. The honorable patient will pay their bill or make suitable arrangements.

CMS Guidance Document

This guidance represents the Centers for Medicare & Medicaid Services' (CMS's) cur-rent thinking on this topic. I. Purpose of this Guidance Document

The purpose of this guidance document is to re-late the factors CMS considers for opening a Na-tional Coverage Determination (NCD). This guid-ance document details: 1) the initial portion of the NCD process; and 2) what CMS considers a complete, formal request necessary to start the formal review process. These procedures relate to the September 26, 2003 Federal Register No-tice on the coverage process (68 Fed Reg. 55634) and describe our current thinking regard-ing these processes. We have taken steps to make the process more collaborative and predict-able. We will be posting potential NCD topics to the coverage web site and are encouraging stakeholder comments on potential topics. We have also made several other explanatory changes throughout the document. II. Background

This is a guidance document required under sec-tion 731 of the Medicare Prescription Drug, Im-provement, and Modernization Act of 2003, which requires the Secretary to make available to the public the factors considered in making na-tional coverage determinations (NCDs) of whether an item or service is reasonable and necessary. For additional information on the background of the Medicare program or on the overall coverage process, please consult the September 26, 2003 Federal Register Notice on the Process for Making Medicare National Cover-age Determinations.

III. Prior to Initiation

The NCD process consists of three major steps: 1) initiation, 2) review, and 3) completion. CMS initiates the NCD process by “opening” the NCD. This is announced to the public by posting a “tracking sheet” on the CMS coverage web site. NCD reviews pertain to reviews of particular items and services to determine whether they meet the statutory requirements. Development of a complete, formal request for an NCD can be initiated either by an outside party or internally by CMS staff. Though requestors and other interested parties are encouraged to provide additional information, clarify issues, and engage in dialogue as ques-tions arise during the development of an NCD, the NCD is likely to be developed and completed in the most timely manner when relevant informa-tion is provided with the initial request. A key goal of publishing guidance documents is to help de-scribe and define the relevant information on which an efficient NCD rests, as well as describe the factors we consider in determining whether an item or service is reasonable and necessary. Therefore, we believe it is important to describe our approach to evaluating the scientific informa-tion submitted, and what constitutes adequate evidence to support NCD development. A. Informal contacts and inquiries The public frequently raises general questions about the coverage of items and services to us by telephone, mail, or in person. These questions may include, but are not limited to, asking us to explain the current coverage of a particular item or service, or requesting assistance with, or ad-

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FACTORS CMS CONSIDERS IN OPENING A NATIONAL COVERAGE DETERMINATION

vice about, possible submission of a formal re-quest for an NCD. We consider all of these con-tacts to be informal and will not announce the substance of these contacts on our web site. These inquiries will not normally trigger the na-tional coverage process until a formal request is submitted by a requestor; however, CMS is not precluded from performing additional research on topics discussed during these inquiries and may elect to initiate the NCD process under its own initiative. If requested, CMS will advise interested parties on how to request an NCD, the implications of such a request, and explain what is needed for us to consider a submission to be a complete, formal request. We will offer suggestions to the requestor to clarify the amount and kind of infor-mation necessary for us to evaluate whether an item or service is "reasonable and necessary" under the Act, and in some instances, we may provide assistance to the requestor in meeting this threshold by assisting them in locating rele-vant evidence. B. Preliminary meetings Preliminary discussions are encouraged for re-questors to discuss issues that may affect review of their requests. These meetings, either in per-son or by teleconference, are useful to conserve both industry and government resources in avoiding duplicative work and to assure that all relevant evidence is submitted in a timely man-ner. The following are some suggested topics that requestors may wish to discuss at these meetings: • Supporting documentation related to the re-

quest • Clinical trial data • Short- and long-term action items that stake-

holders may adopt • Expectations of evidence in the process and

information on the applicability of the item or service in question to the Medicare popula-tion

CMS, in turn, may:

(Continued from page 7) • Discuss components and concepts of the

NCD process, including but not limited to, benefit category determination, the NCD timeline, evidence-based medicine, local vs. national coverage determinations, FDA and CMS relationships, and other items

• Provide initial evaluation of supporting docu-mentation presented by the requestor

• Provide initial information on the likely scope of the review and assessment questions

• Provide initial opinions on the applicability of the item or service in question to the Medi-care population

• Provide information on the complete NCD process

Preliminary discussions will not always lead to the initiation of an NCD. Furthermore, while meetings with stakeholders are not confidential, we will attempt to protect the confidentiality of any documents submitted during these meetings to the extent permitted by law and will not post the substance of preliminary meetings. IV. Who Can Request an NCD Development of a complete, formal request for an NCD can be initiated either by an outside party or by internal Agency personnel. A. Requests by external parties A request to make an NCD can be received from an individual or entity who identifies an item or service as a potential benefit (or to prevent po-tential harm) to Medicare beneficiaries. A re-questor may be a Medicare beneficiary, manu-facturer, provider, supplier, medical professional association, health plan, or other party who re-quests our consideration of a particular issue for an NCD. In certain cases (e.g., an individual lay-person), a requestor may not have the resources to identify evidence needed to meet the reason-able and necessary standard. In these rare cases, we may assist the requestor in locating the necessary evidence.

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B. Requests by aggrieved parties Section 1869(f)(4) of the Social Security Act per-mits certain aggrieved persons to make a request that the Secretary issue a national coverage or noncoverage determination with respect to a par-ticular type or class of items or services, if the Secretary had not previously made a coverage or noncoverage determination. These individuals are described in section 1869(f)(5) of the Act as "individuals entitled to benefits under Part A, or enrolled under Part B, or both, who are in need of the item or service that is the subject of the cov-erage determination." Thus, this track can be invoked only for an initial request if we have not issued a coverage or noncoverage NCD. We realize that in these very rare instances re-lated to requests made by aggrieved parties, the statute establishes specific time deadlines and we will notify the requestors when these situa-tions arise. C. Requests initiated internally National Coverage Determinations are discussed in sections 1862, 1869, and 1871 of the Social Security Act. We may internally generate a re-quest to develop an NCD in the interest of the general health and safety of Medicare beneficiar-ies. Generally, once initiated, this process is simi-lar to the externally-generated request process. The following are circumstances that may prompt CMS to generate an internal NCD request on an existing technology already in use: • Providers, patients or other members of the

public have raised significant questions that are supported by CMS’s initial review of available data about the health benefits of currently covered items or services, specifi-cally regarding the Medicare population.

• Interpretation of new evidence or re-interpretation of previously available evi-dence indicates that changes may be war-ranted in current policies.

• Local coverage policies are inconsistent or conflict with each other to the detriment of Medicare beneficiaries. For instance, the

(Continued from page 8) noted variation is not related to local differ-ences in the capabilities of health care pro-viders to use the technology effectively which can be resolved over time, but, rather, it is causing significant disparities in the care available to Medicare beneficiaries that are unlikely to be addressed effectively through provider training and education or through the local coverage process.

• Program integrity concerns have arisen un-der existing local or national policies; that is, there is significant evidence of wide variation in billing practices not related to variation in clinical need or of potential for fraud under existing policies.

An internally-generated NCD may also be con-sidered for a new item or service, an existing item or service that has been substantially modi-fied, or for a proposed new use of a covered product if: • The health technology represents a substan-

tial clinical advance and is likely to result in a significant health benefit if it diffuses more rapidly to all patients for whom it is indicated.

• More rapid diffusion of the technology is likely to have a significant programmatic im-pact on Medicare and on other Medicare-related public policies (e.g., reduction in health inequalities).

• Significant uncertainty exists concerning the health benefits, patient selection, or appropri-ate facility and staffing requirements for the new technology. The presence of significant uncertainty about benefits and risks is of par-ticular concern when rapid diffusion of the item or service is likely when:

ο use of the new item or service likely conflicts with existing NCDs

ο available evidence suggests that local variation is not warranted

Cost effectiveness is not a factor CMS considers in making NCDs. In other words, the cost of a particular technology is not relevant in the deter-mination of whether the technology improves health outcomes or should be covered for the

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Medicare population through an NCD. Before deciding whether to generate an NCD, CMS may consult with relevant beneficiary groups, professional bodies and/or manufactur-ers of the technologies in question using the pub-lic comment function available on the coverage web site. Specifically, we will usually announce potential topics that are being considered for in-ternally-generated requests on our web site on a quarterly basis and allow interested stakeholders to comment on these topics. The purpose of these announcements is both to enable inter-ested parties to provide any additional informa-tion as well as comments. Furthermore, these announcements will provide advance notice to the public regarding potential topics that we are considering and allow stakeholders to suggest additional topics for consideration, creating a more transparent and predictable NCD process. The public is encouraged to comment on poten-tial topics and provide relevant evidence on whether a review should or should not proceed prior to the formal decision to open an NCD. We are attempting to balance the public’s desire to comment extensively on potential topics with the inherent resource and time constraints in the NCD process. Due to these resource and time constraints, the public comment function avail-able on the coverage web site will be the primary tool used to solicit input regarding this stage of the NCD process; stakeholders bear the respon-sibility for reviewing the quarterly list and submit-ting comments or evidence that they believe to be relevant. V. What Constitutes a Complete, Formal Request for an NCD There are several ways an individual or entity can contact us about NCDs. One approach in-volves informal contacts, as described above. The other approach involves "formal requests" and may result in the official opening of an NCD. The latter process will be initiated when we re-ceive a complete, formal request. A request is considered to be “received” once certain condi-tions are met. These conditions include:

(Continued from page 9) • A formal request letter and supporting docu-mentation submitted electronically (unless there is good cause for only a hardcopy sub-mission).

• The request is identified as a "formal request for an NCD."

• The request states the benefit category or categories of the Medicare program to which the requestor believes the item or service applies. Examples of benefit categories in-clude durable medical equipment, physician services, inpatient hospital services, and di-agnostic tests. The requestor may recom-mend one or more benefit categories for the item or service and submit supporting docu-mentation justifying the recommendation. All the information needed to make a benefit category determination, (including that pro-vided by the requestor and generated by the agency) should be in place before the re-quest can be considered complete. In in-stances when ambiguity may exist, CMS will need to carefully analyze whether the item or service falls under a benefit category deter-mination before opening an NCD in order to ensure that there is an applicable statutory category. If an item or service can fit into more than one benefit category, we have the discretion to assign it to the most appropriate one.

• The requestor should submit adequate sup-porting documentation along with the formal letter, including a full compilation of the sup-porting medical and scientific information currently available that measures the medical benefits of the item or service. Additional in-formation on documentation will be dis-cussed in the guidance document on eviden-tiary standards.

After we receive a request for an NCD and deter-mine that the requested item or service requires a benefit category determination from the Center for Medicare Management (CMM), we forward a copy of the request and appropriate supporting documentation to CMM. CMM reviews the mate-rials supplied by the Coverage and Analysis Group (CAG) in addition to any other relevant information to determine whether the Social Se-

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curity Act provides a benefit category for the item or service. Local coverage is not pre-empted simply by the initiation of an NCD or a request for a technology assessment or Medicare Coverage Advisory Committee review. Opening an NCD does not change local coverage policies. Once a final NCD is issued., local contractors must amend or withdraw any inconsistent LCDs. VI. CMS Review of a Formal Request When a requestor submits a request for an NCD, we review the materials to determine if it meets the definition of a complete, formal request. If the request lacks adequate supporting documenta-tion to enable us to conduct our review, we notify the requestor and explain our rationale. For in-stance, we may advise the requestor that the quality of the evidence appears limited. However, we will not decline a request simply because the evidence presented seems insufficient. Requestors are encouraged to schedule and complete a preliminary meeting with the appropri-ate CAG personnel. At this meeting, a prelimi-nary review of the item or service and supporting documentation can be presented by the re-questor, and any additional information that might be necessary can be requested by CAG person-nel. Preliminary meetings are also the appropri-ate place for the requestor to submit clinical trial protocols for review, if relevant. Once the request is considered “received,” we post the request on our web site under our list of pending coverage issues. Posting of the tracking sheets permits interested individuals to partici-pate in and monitor the progress of the NCD process. This is a key element in making our NCD process more efficient, open, and accessi-ble to the public. Once a formal request is posted, there will be additional opportunities for public participation and submission of additional evidence (such as the initial 30-day comment period and 30-day comment period on the draft NCD). We continue to expect that a requestor will sub-

(Continued from page 10) mit all evidence currently available pertaining to the issue of whether the item or service is rea-sonable and necessary. In the absence of ade-quate evidence, we may conclude that the item or service is not reasonable and necessary or leave the issue for local contractor discretion. VII. Proprietary Data In section 1862(a)(in the matter following (22)) of the Act, the Congress provided that the Secretary was not required to disclose “proprietary data” to the public when making available the data con-sidered in making the determination. This excep-tion serves to encourage manufacturers and oth-ers to submit evidence that would be useful in making NCDs. Prior to this statute, manufactur-ers may have been reluctant to submit valuable business and commercial data if they believed it would be publicly disclosed as part of a record in a judicial proceeding. This provision enables the Secretary to receive and consider proprietary data and to assure that proprietary data will not be disclosed except as required by law. Our abil-ity to obtain proprietary data may enable us to develop NCDs, including determinations that may expand Medicare coverage, more rapidly and accurately. We believe the statutory protection accorded pro-prietary data ensures the availability of the best relevant information and maximizes flexibility in developing coverage determinations. VIII. Prioritizing Requests In the rare event that we have a large volume of NCD requests to review at once, we retain the flexibility to prioritize these requests based on the magnitude of the impact on the Medicare pro-gram and beneficiaries. This flexibility will enable us to ensure that we can pay priority attention to those requests that have potential for significant impact on our beneficiaries—a life-saving cancer treatment, a breakthrough in cardiac pacing, etc. IX. Role of the Council on Technology and Innovation (CTI) While not a direct component of the NCD proc-

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ess, the CTI allows better coordination of the NCD process and coverage issues across CMS. The CTI is comprised of senior level CMS lead-ers and experts on clinical, coverage and pay-ment issues. The Council’s mission is to provide CMS with improved methods for developing prac-tical information about the clinical benefits of new medical technologies resulting in faster and more efficient coverage and payment of these medical technologies. Through the Council’s efforts, CMS is better able to coordinate the coverage process with other related activities, such as payment and coding. X. Where to Submit a Complete Formal Re-quest Electronic requests may be submitted via the coverage web site using the “Contact Us” link. Requests may also be submitted in electronic format by mail to:

Centers for Medicare and Medicaid Services Director, Coverage and Analysis Group 7500 Security Blvd Baltimore, MD 21244 XI. Conclusion Proper application of the principles and proce-dures outlined in this guidance document can promote public health and access by speeding the development of NCDs and can assure that NCDs are both accurate and timely.

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Compiled by John Allman

Home Infusion Provider Accreditation News From National Home Infusion Association On August 11, the HomeCare Monday electronic newsletter reported that CMS has established a date of December 2, 2008 for any DME supplier to be accredited for which a hospice (paid by Medicare or Medicaid) may contract with for ser-vices. This is based on publication of hospice conditions of participation in regulations to be-come effective December 2. As CMS's requirements for DMEPOS accredita-tion apply to home IV providers since most are Medicare DMEPOS suppliers, NHIA immediately asked CMS to clarify the publication's interpreta-tion. On a CMS Open Door Forum, NHIA re-quested clarification and urged CMS to address this quickly. If you wish to view the regulation prompting the HomeCare Monday story, look for it on page 127 in the right hand column, middle: http://edocket.access.gpo.gov/2008/pdf/08-1305.pdf . While a home infusion therapy provider may al-ready be accredited as an infusion pharmacy from the Accreditation Commission for Health Care, the Community Health Accreditation Pro-gram or The Joint Commission, this does not necessarily mean it is also accredited for Medi-care DMEPOS quality standards. Some of the accreditors are calling the latter "DME accredita-tion." Hence, CMS accreditation deadlines are notable for most home infusion pharmacies even though you may have been accredited already by one of these organizations. Suppliers should check with their accreditor to find out the details on what they must have as documentation to sat-isfy the CMS deadlines.

PDAC Contract Effective August 18, 2008 Noridian Administrative Services, LLC (NAS) will assume the duties of the Pricing, Data Analysis and Coding (PDAC) contract on August 18, 2008. Below are important details about the transition of these functions from the SADMERC, Palmetto GBA, to NAS. • Effective August 18, 2008, all product review

forms and corresponding documentation, along with product samples, if applicable, should be mailed or faxed to PDAC using the addresses and fax numbers listed below. Any written or email inquiries should also be di-rected to PDAC starting August 18.

• The PDAC HCPCS product review forms are located in the HCPCS Review section of the PDAC Web site, http://www.dmepdac.com. These forms are fillable and savable which means that you can save this form to your computer. Information completed each time these forms are filled out can also be saved.

• When sending HCPCS product review forms, only one application with supporting docu-mentation is required. Multiple copies of these documents are no longer required. Please discontinue using any SADMERC forms as of August 18.

• PDAC will send an acknowledgement letter for all product reviews transferred from SAD-MERC to PDAC.

• Starting August 18, you can use the Contact Us page on our Web site to send us a ques-tion or inquiry.

• The PDAC Contact Center hours are 8:30am - 4:00pm CT. The PDAC Contact Center will be operational as of 8:30am CT on Monday, August 18.

• Reminder: The HCPCS Helpline will be un-available as of 12:00 noon ET on Friday, Au-gust 15.

• As of August 18, the DME Coding System (DMECS) will be accessible from the PDAC Web site.

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Also of Interest

ALSO OF INTEREST

PDAC Contact Center: 1-877-735-1326 Hours: 8:30am - 4:00pm CT Fax: 1-866-209-1236 Mailing Address Pricing, Data Analysis and Coding PO Box 6757 Fargo ND 58108-6757 Courier Address Pricing, Data Analysis and Coding 900 42nd Street South Fargo ND 58108-6757 GAO Fools CMS The Government Accountability Office (GAO) released a report last week that gives credence to the industry's long-standing argument that CMS is partly to blame for the fraud and abuse that plagues the HME industry. Earlier this year, the GAO set up two sham HME companies as part of a continuing investigation into CMS's enrollment and inspection process. The GAO was able to get the companies ap-proved for Medicare billing privileges, even though they didn't have clients or inventory In 2005, the GAO found that CMS's efforts to verify compliance with enrollment standards were insufficient due to weaknesses in its ability to check state licenses and conduct on-site inspec-tions. CMS promised to beef up its verification process--not enough, the GAO says. Industry stakeholders plan to use the report as a launching pad to have conversations with CMS and legislators about how to fix the enrollment and inspection process, as well as what role the industry can play in helping them do that. For the full report: http://www.gao.gov/cgi-bin/getrpt?GAO-08-955

(Continued from page 13) HHS Takes New Steps to Accelerate Adoption of Electronic Prescribing Medicare Payments for Successful Electronic Prescribers, Reporting Quality Data are Im-portant Steps Toward a Value-Driven Health Care System Medicare is starting a new program to encourage physicians to adopt e-prescribing systems. In-centive payments will be available beginning in 2009 for physicians who meet the requirements of the program. The initiative is part of the Ad-ministration’s broader efforts to accelerate the adoption of health IT and the establishment of a health care system based on value. Beginning in 2009, and during the next four years, Medicare will provide incentive payments to eligible professionals who are successful elec-tronic prescribers. Eligible professionals will re-ceive a 2 percent incentive payment in 2009 and 2010, a 1 percent incentive payment in 2011 and 2012, and a one half percent incentive payment in 2013. Beginning in 2012, eligible professionals who are not successful electronic prescribers will receive a reduction in payment. Eligible professionals may be exempted from the reduction in payment, on a case-by-case basis, if it is determined that compliance with requirement for being a suc-cessful prescriber would result in significant hard-ship. To read more, see the entire HHS Fact Sheet at http://www.hhs.gov/news/facts/eprescribing.html.

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Also of Interest

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R3 Subscribers may choose any one e-Conference at no additional charge. Additional e-Conferences for R3 subscribers are charged at $67.00 each. Twenty-four hour cancellation notice required.

Reimbursement and Regulatory Resources R3 Webinar SERIES

AUGUST 2008 ---------------------------------------------------------------- Legal Issues in Seating and Wheeled Mobility Wednesday, August 20 at 11:30 EDT Jeffrey Baird, Esq., Chairman, Health Care Group, Brown & Fortunato There are risks in any form of healthcare related service delivery. This session will explore the specific risks associated with the provision of DME equipment in general and laser in on Complex Rehab and Assistive Technology in general. You will become familiar with the current documentation requirements for power mobility devices, know what documentation must be on file before delivering equipment and other hot button issues for suppliers of power mobility devices.

Cost for each e-Conference session: $ 150.00/seat (A SEAT IS DEFINED AS ONE COMPUTER/PHONE CONNECTION)

Webinar Series

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MED Business Solutions eConference Suites These specially designed Suites will consist of three ninety-minute eConferences held on three consecutive weeks. They are not part of regular R3 or other network membership package. The MED Group has found a number of interesting and informative topics to be addressed to meet your operational and educational needs.

Leadership Series - Presented by Dr. Gary Schwantz

Session One - Basic Leadership Skills and Motivation Thursday, August 21 at 12:00 noon EDT An overview of the skills of management and leadership in your department and/or your company in a style that (as they say in the country) puts the hay down where the goats can get it! The intent is to make application of these principles practical and useful:

• Your leadership and personality type using True Colors • The roles of management • The functions of management applied to HME • Creating an environment of trust • Setting the tone of the organizational culture • Keys to understanding and offering motivation

Session Two - Communication and Conflict Resolution and Team Building Thursday, August 28 at 12:00 noon EDT You already know that communication is a key of successful companies and successful teams. Interestingly enough, so is the presence of conflict – what’s important is how to deal with it. This session reminds you of several skills in communication, including dealing with conflict. We will discuss building trust as a foundation, with a final focus on the necessity of effective communication in building teams. Elements include:

• Conflict • Team Building

Session Three - Leadership During Change Thursday, September 4 at 12:00 noon EDT We are in a changing and challenging industry. It is during change when leadership (a step beyond management) really comes into play. This session will discuss several elements in preparing for and dealing with change, including dealing with the inherent stress. The focus will be practical, down-to-earth elements you can apply immediately in helping your staff and your company deal with change.

• The processes of change • Key elements in preparing for change • Managing change and stress • Celebrating successes

Call your Member Services Representative at 800.825.5633 or log into the eConference registration website (www.medgroup.com/ecs) to reserve your seat today! The Suites are package priced at $300 per Member the price includes access to the eConference, the CD and handout materials. The Suites will be recorded and available for playback on CD along with printed handouts

Webinar Series

Chris Calderone has over 17 years experience in the healthcare and HME field. Chris spent 13 years at the University of Michigan Health System – Home Care Ser-vices Division as a Quality Improvement Project Manager focusing on lean thinking quality concepts and general performance improvement projects. He is currently a qual-ity improvement specialist and internal performance im-provement consultant at a large community-based hospi-tal in Michigan. Chris is also the founder of the Lean Homecare Consult-ing Group, LLC which provides expert lean training, proc-ess assessment, process design services, and workflow optimization strategies to HME providers and other health-care providers. Chris has written several articles for HME News and HomeCare Magazine, and he has been a fea-tured speaker on lean and quality improvement topics at many national and regional HME/healthcare seminars and conferences. Chris is a veteran of the United States Army, and he holds an MBA and a master’s degree in organizational management. Chris received his lean train-ing and quality improvement training at the University of Michigan. .

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You are encouraged to distribute this publication among your staff where appropriate. Reproduction with attribution permitted. Past issues of Reimbursement and Regulatory Resources are also available on the R3 Website at: www.medgroup.com. You may wish to bookmark this page and refer to it frequently. Reimbursement and Regulatory Resources is a corporate newsletter intended as an information source only. This publication is designed to provide accurate information in regard to the subject matter. It is distributed with the understanding that the publisher is not engaged in rendering legal, accounting, and other professional services. If legal advice or other expert assistance is required, the services of a competent professional should be sought. Copyright 2008, The MED Group Reproduction with attribution permitted.

Reimbursement and Regulatory Resources PUBLISHED MONTHLY BY THE MED GROUP Edited by John Allman, Director, Business Solutions Copy Editor, Natalia Urbina Business Solutions Specialist 3223 South Loop 289 Lubbock, TX 79423 Phone: 800-825-5633 Fax: 806-792-4499 email: jallman@medgroup.com nurbina@medgroup.com

Contributing This Month

About R

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Keith Lilek President and founder of A/R Allegiance has 20-plus years of experience in the industry. Years of real-life client feedback and study has gone into the develop-ment of this first-ever solution that takes the whole A/R process into consideration. Keith continues today to teach clients how to properly manage the accounts receivable cycle. Through Keith’s experience, A/R Allegiance was therefore able to combine extensive experience in two crucial areas: A/R management and technology—to de-velop CollectPlus™, effectively going beyond collections to offer clients a better way of doing business. He may be contacted at (800) 874-2848 or by email at kli-lek@ARallegiance.com. Vianna Zimbel, BS, RCP works with rehab and respira-tory companies in achieving accreditation and meeting regulatory requirements. Vianna has 30 years of clinical respiratory therapy experience and is the former National Home Care Services Manager for Lincare. In preparing companies for accreditation, she also ensures compliance with the F.D.A., O.S.H.A., D.O.T., and other regulatory agencies. She can be reached at (860) 657-9530 or vzim-bel@aol.com.