[This Transcript is Unedited]
J.W. Marriott National Place
1331 Pennsylvania Avenue, NW
Washington, DC
DR. COHN: This is the second of two days of hearings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. The committee is the main public advisory to HHS on national health information policy. I am Simon Cohn. I'm the national director for health information and policy at Kaiser Permanente, a member of the committee and chair of the subcommittee.
I want to welcome fellow subcommittee members, HHS staff, and others here in person. I also want to welcome those listening in on the Internet.
Today we having a session that starts at 8:30 am. We just started. We will adjourn at about 1:00 pm today. The focus will be on our new responsibilities resulting from the passage of the Administrative Simplification Compliance Act. The focus of the hearings in relationship to that has to with the development of a model compliance form by HHS for the industry and the country. We will also discuss in the remaining, the annual report on administrative simplification we are preparing for Congress and the secretary.
With that, let's have introduction around the table, and then around the room. As is usual, for those on the National Committee, there are issues coming before us today that there is conflict. If you have, will you please identify it, and identify that you are going to be recusing yourself from the discussion and/or voting on those topics.
With that, Jeff, do you want to start the introductions?
MR. BLAIR: I'm Jeff Blair, vice chair of the subcommittee. I'm vice president of the Medical Records Institute, a member of ANSI HSB, NSA's(?) HL7, ASTM, AHIMA(?). And there is nothing that I know of that I need to recuse myself from.
DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation, member of the committee and the subcommittee. I'm also chair of the Committee(?) for Electronic Health Care Transactions, a member of WEDI, NCPDP, AMA, and ASTM.
MR. AUGUSTINE: Brady Augustine, corporate director for special projects for Gambro Healthcare and a member of NCVHS.
MR. SCANLON: I'm Jim Scanlon from HHS, Office of Planning and Evaluation. I'm the executive staff director for the committee.
MS. GREENBERG: I'm Marjorie Greenberg from the National Center for Health Statistics, CDC. And I'm executive secretary to the committee.
MR. MC LAUGHLIN: Mark McLaughlin. I'm with McKesson.
MR. ARGES: George Arges with the American Hospital Association and chair of the National Uniform Billing Committee.
MS. DOYLE: Theresa Doyle. I'm a consultant to Blue Cross/Blue Shield Association, and I'm here on their behalf.
MR. WILDER: Tom Wilder with the National Association of Health Plans.
MS. NARCISI: Jean Narcisi, American Medical Association, and chair of the National Uniform Claims Committee.
MR. TENNANT: Robert Tennant, Medical Group Management Association and the Work Group of Electronic Data Interchange.
DR. FITZMAURICE: Michael Fitzmaurice, senior science advisor for information technology, the federal Agency for Healthcare Research and Quality, liaison to the National Committee, and staff to the Subcommittee on Standards and Security.
MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Management, staff to the subcommittee.
[Additional introductions were made.]
DR. COHN: Welcome everyone. Our panel this morning is on the development of the model compliance form. I think our first presenter will be Robert Tennant representing WEDI and MGMA.
MR. TENNANT: Thank you, Mr. Chairman, and thank you for inviting WEDI to present here today. My name is Robert Tennant, and I'm with the Medical Group Management Association. I serve on the WEDI executive committee and board of directors, co-chair their Strategic National Implementation Process, and chair WEDI's Compliance Task Group that I will be focusing on today.
As you know, WEDI is named in the original HIPAA legislation and in the Administrative Simplification Compliance Act as a consultant to the government. We are very pleased that the NCVHS has taken on this role, and in my testimony today I will be outlining what this task group did, how it was formed, some of the recommendations, and raise a few continuing issues that the task group focused on.
As soon as the bill was introduced, 33-23 in the House, WEDI decided to create this task group, because we looked at the language, and we saw that there was some necessity to develop some recommendations about how this model compliance form might look like. We invited leaders from across WEDI's membership, those who would be most impacted by this model compliance form or MCF.
We got together about 25-30 folks, and we held numerous conference calls discussing various recommendations. We came up with a draft of the actual form. We then had a face-to-face meeting sponsored by APEC and the American Hospital Association with about 30 participants, including some from HHS and CMS.
At this meeting, we even further refined the recommendations. We got a lot of good industry consensus on the way we had developed the model form. And we brought those back to the task group. They approved most of them. We moved forward very quickly, and the board of directors of WEDI approved the recommendations and the model compliance form on January 26, 2002.
Key recommendations coming from WEDI's task group. In terms of general issues, we believe that the model compliance form should be used to raise issues for the NCVHS, not to challenge or test submitters. The task group was adamant in that one size should fit all. There shouldn't be multiple forms for different covered entities.
Also, the model compliance form should be viewed as a tool to assist covered entities in developing their compliance plans. So somebody looking at this form should be able to begin to craft their compliance plan.
In terms of delivery mechanisms, we believe that the model compliance form should be available in both electronic and paper forms. The law stipulates electronic, but we believe that there will be many small providers that will not have access to this Internet version; that a paper form must be made available.
And then that leads into how should these folks be able to get this model compliance form? We recommended that there be a fax on demand system, where somebody could call a number, leave their fax, and it would be faxed out to them automatically. As well, potentially a written form could be mailed out to them, or a Web-based PDF format where somebody could go there and download the PDF format, fill it out, and mail it back.
It is also recommended that HHS disseminate only scanable versions of these documents to facilitate the requirement to submit samples to the NCVHS.
In terms of the content of the form, again, the consensus from the task group was keep it simple. It should be as easy to fill out as possible. All entities, from the most complex multispecialty clinic, to a small dental clinic should be able to fill out this model compliance form extremely easily and fast.
We also recommended that the work plan implementation strategy and the testing categories all be combined. For each phase, they would be asked whether or not they had completed their compliance plan. Again, the consensus of the task group was not to challenge those submitting these forms, but rather make it a quick and easy form to fill out.
We also recommended that there should be a preamble to this model compliance form that provides a brief explanation of HIPAA in general, the transaction code set specifically, explains the legislation that is mandating this form, the purpose of the extension, and of course how to complete the model compliance form.
In terms of ancillary documents, we believe strongly that the Web site should include links to relevant information, for example, the final rule for transactions and code sets, documents allowing those developing their compliance plans, to move forward quickly. And as well, the paper forms should provide links to relevant Web sites.
Of course for both Web and paper, there should be a glossary of terms. A lot of folks in this room know all the terms, but a lot of folks in the industry do not. Potentially, a toll free number to allow folks with questions about filling out this form, they could call HHS to get those questions answered.
As well, we recommended that information for providers relating to this extension be included in Medicare summary notices.
In terms of HHS response, we recommend that there be an auto response feature to the Internet-based form to allow a recipient to get an email saying that they had received their model compliance form.
Receipt of this compliance form should be viewed as equivalent to being granted the one year extension. That was clearly a consensus by the task group. However, form letters will need to be developed to acknowledge those submitting by mail. That is one potential. The other one is that people be encouraged to send return receipts, or send it by FedEx and keep a receipt of this model compliance form.
In terms of critical issues still to be resolved, there is obviously the question of how will HHS handle the extremely large volume of submissions. Some expectations are in the hundreds of thousands. It's certainly a daunting task, and one that will not be easy to solve.
Another critical issue for the task group was can organizations apply on behalf of multiple entities? For example, insurance plans want to have the flexibility to apply for the extension on behalf of their subsidiaries and appropriate business partners.
And medical group practices want to be able to file on behalf of their individual physicians. Should a large multispecialty clinic be forced to have each of their providers submit a compliance plan, we are talking about potentially thousands coming from each organization, very unwieldy.
Of course, how will entities be granted their extension? There is a lot of confusion right now in the industry about how will covered entities know that they have been granted this one year extension.
Another key issue, will the public have access to these compliance forms? We all know under the Freedom of Information Act this information is available. But how will that be made available? Will people be able to get batches of them? Or will they have to apply individually for specific covered entities?
And of course a key concern is the legislative mandate to the NCVHS to report on solutions. That is a Herculean task ahead for the NCVHS to analyze this representative sample of the forms to identify key implementation barriers, and develop solutions to these barriers.
Then once they have developed the solutions, getting that information out to the public. There is a very short window of opportunity for the NCVHS to accomplish these tasks. And for this information to be useful, this information needs to get out as quickly as possible to the industry. WEDI reaffirms its commitment to provide support to the NCVHS as you move forward to complete these mandates.
In conclusion, let me just say that WEDI is extremely well positioned to assist the NCVHS. As you know the Strategic National Implementation Process has developed a wealth of practical, consensus crafted white papers on many of the implementation issues facing the industry today. Much of this work falls within the NCVHS mandate, and WEDI stands ready to work with the NCVHS to fulfill this legislative directive.
Thank you for inviting WEDI to testify, and I would be happy to entertain any questions.
DR. COHN: Thank you. Jean Narcisi, are you presenting the American Medical Association today or the National Uniform Claims Committee?
MS. NARCISI: I am representing the AMA today.
DR. COHN: Thank you.
MS. NARCISI: My name is Jean Narcisi, and I'm the director of the Office of Electronic Medical Systems at the American Medical Association. I also chair the National Uniform Claims Committee.
It is my pleasure to appear today on behalf of the AMA before the Subcommittee on Standards and Security of the NCVHS. I would like to thank you for the opportunity to testify regarding the AMA's views on the HIPAA model compliance extension form.
To begin, we would prefer that the model form be called an extension form, rather than a compliance form. It would be both alarming and confusing to many physicians to call it a compliance form, because they understand compliance plans to be a much more complex and burdensome undertaking than what is required by the Administrative Simplification Compliance Act.
The act only requires that covered entities submit to the Department of Health and Human Services a summary of how they plan to come into compliance with the final rule on transactions and code sets, as opposed to a detailed compliance plan. In addition, the statute only requires submission of the form to obtain the benefit of the extension. It does not require justification of the sufficiency of the covered entity's compliance activities.
With that in mind, AMA urges those drafting the form to recognize the very purpose of administrative simplification is to simplify health care transactions, and to reduce the associated administrative burden and complex, not add new burdensome requirements.
Small physician practices are already overwhelmed with the work necessary to implement all of the HIPAA requirements. The AMA believes that physicians should be able to know what will be required under the remaining HIPAA regulations, and where the various rules requirements will overlap before costly administrative and technology changes are made to their practices. Therefore, we encourage HHS to move expeditiously to promulgate the remaining HIPAA rules so physicians can implement the HIPAA requirements in the most cost effective manner.
The AMA will be advising our members that if there is any potential whatsoever that their practices will not be compliant with the transactions rule by October 2002, they should file for the extension. Nevertheless, we will continue to urge physicians to come into compliance with the transactions rule as soon as possible. Given the penalties associated with not filing for the extension and/or not being compliant, physicians should take compliance of the transaction rule very seriously.
Because the modifications to the transactions rule have not been finalized, we believe most, if not all physicians will feel the need to submit an extension form in order to insure they have made all required changes to their systems. In addition, there will be a lot of uncertainty as to whether other covered entities with which physicians submit covered transactions will be compliant in October 2002, or submit an extension form.
This will create anxiety over whether or not the physicians themselves should submit an extension form, even if they anticipate that they will be compliant. Though potential penalties associated with the failure to submit an extension form, and concurrent non-compliance, especially potential exclusions from the Medicare program will increase the likelihood that a large number of covered entities will want to submit an extension form just to be safe. Therefore, HHS should be prepared to establish a simple and effective process to receive and acknowledge a very substantial number of forms.
We believe that the model form, and its yet to be developed instructional companion guide can and should be educational. It should also be as simple as possible. We believe that the model form developed by the WEDI Compliance Task Force is an acceptable approach to the HHS model extension form. It was based upon the deliberative work and consensus of numerous health care groups that represent covered entities under HIPAA, including the AMA.
Although we understand that the Centers of Medicare and Medicaid Services will have the ultimate responsibility for drafting the model extension form and the instructional companion guide, the AMA believes the WEDI model should be considered and adopted to the maximum extent possible.
The WEDI model is a simple form, so it would encourage compliance, and it is a single format, so it would apply to all covered entities. It also would require a minimum amount of information, yet it both conforms to the intent of the act, and would simplify the limited analysis required by NCVHS under the statute.
The AMA believes physicians will find the WEDI form relatively easy to complete. In order to test WEDI's assumptions that the form will be easy and practical for covered entities to complete, the urge CMS to conduct focus groups with all types of covered entities. This type of feedback has been very helpful in the NUCC's work with HHS in similar situations with the evaluation of the HCFA 1500 claim form.
The WEDI form includes one consideration that is very important to the AMA. The AMA strongly recommends that a representative of a physician practice be able to submit the form on behalf of the practice, even if the practice has numerous physicians and/or maintains multiple offices. The form could be completed by the person that has the most knowledge about the compliance activities about the practice, if the physician who has responsibility as the cover entity will get credit for filing an extension.
The instruction form should state clearly that a physician need not be the one who actually submits the forms, but the privacy officer or any other individual responsible for the HIPAA compliance for the physicians' group practice may submit the form on behalf of the physicians in the group.
In addition, in order for all physicians to get credit for the extension, we urge CMS to require the full name and unique provider or physician identification number, tax ID number, or other appropriate identifiers for each physician or other covered entities to whom the extension would apply if applicable. It may be necessary to allow an attachment of some sort, or a large enough field on an electronic form in order to fit the names and identification numbers of all physicians in a very large group practice.
In our experience of managing the AMA's physician master file database, which includes over 850,000 uniquely identified records of physicians, there can be hundreds of physicians with the same name. We acknowledge that the recording of each covered entity is a large task, yet we seek to insure that physicians that file an extension, or have an extension filed on their behalf are appropriately recognized.
Equally important, there must be some way to provide a receipt of assurance that the form has been received by CMS and processed, so that each physician or covered entity will be able to verify that he or she has received the extension. The acknowledgement can be sent to the individual who submits the form, whether or not they submitted a form on behalf of others.
If CMS plans to create a registry for this purpose, or for the purpose of providing information to the public about which covered entities filed an extension form, we urge CMS to publish only the name of the covered entity. If additional information is required, we urge CMS to publish only minimal published information such as address or zip code of the covered entity. Any additional information would not be necessary, and should not be made available to the general public on any such public registry.
We will urge our members to communicate with their vendors and payers well before testing begins so that they are apprised of the status of other covered entities with whom they exchange transaction information so they can coordinate testing activities. The act requires that the summary of compliance activity include a time frame for testing to begin no later than April 16, 2003.
Because this date is a specific requirement in the statute, we urge CMS to insure that this is clear on the forms. The form should not even allow a covered entity to indicate a later date for testing, because if a physician or other covered entity were inadvertently to do so, the form he or she would submit would not on its face comply with the act's requirement for the extension.
Although the act does not require that the contents of the forms be approved before a covered entity would receive an extension, we are concerned about the potential that a physician might be subject to penalties or exclusions from Medicare based on a later legal interpretation that the physician did not in fact receive the extension.
The simplicity of filing the form will be as important as simplicity of the form itself. The form should be made available online on the CMS or HHS Web site, and in a hard copy format. Covered entities should be able to submit the form both electronically, and by fax or mail.
The extension process will undoubtedly be an excellent for CMS to educate covered entities on the requirements of the transactions rules and administrative simplification in general. The AMA will also use every practical means possible to educate our members about the extension forms, and the work necessary to develop an adequate plan for compliance with the transactions rules.
CMS should anticipate that there will be many questions about the extension, the extension form, how to fill it out, and HIPAA compliance in general. Frequently asked questions should be prepared, and other methods of education should be considered, and all should be widely disseminated or made available to physicians. In addition, Medicare carrier personnel who interact with physicians should be prepared to respond appropriately to questions.
At this point, an instruction document to accompany the form has not been drafted. The instructions for the extension form will be a critical educational piece for physicians and other covered entities. Because the AMA believes the instructions will be as important as the extension forms, we would like to work with CMS to develop the instructions. They should be very simple and concise. Long and complicated instructions would be confusing and intimidating, and may discourage many covered entities from promptly submitting the forms.
Physicians may even feel the need to hire consultants if the form and instructions are complicated. The form should not create the potential for such counterproductive behavior that is contrary to the intent of administrative simplification.
We recommend that instructions be very clear that certain parts of the form may generally apply to all covered entities, while other parts may not require a response by all covered entities. The instructions should adequately explain which answers to the form are mandatory, and which are optional for particular covered entities.
As mentioned earlier, the form and the instructions should make it very clear that submission of the completed form will automatically result in an extension, and that there is no approval process involved. Likewise, it should be very clear that physicians and other covered entities would not be penalized for merely submitting the extension form.
Many physicians have developed a paranoid view of government compliance activities, particularly in light of the many cases of overzealous prosecution of physicians that merely made mistakes. HHS must make this a simple, straightforward process that will reassure physicians that complying with the law by filing the form will not result in any type of enforcement action by the government.
It is likely that many covered entities may miss a deadline, or miscalculate the resources needed to come into compliance. Therefore, the instructions should state that covered entities will only be expected to fill out the form as accurately as possible based on the information available to them at the time the form is submitted. Physicians should be reassured that there will be no penalties if circumstances change, if the actual implementation is different than what was originally put on the form.
For instance, an initial budget estimate might require an adjustment as technology-based projects often do. Unanticipated events may lead the covered entity to utilize a different approach or alternative timeframe than what may have been indicated on the form. Physicians should feel comfortable continuing their compliance activities as they deem necessary and appropriate, free from fear of retribution by the federal government, with the goal of coming into compliance in a timely fashion.
The AMA will do all it can to alert and educate our members about the extension form and how to submit the form as soon as possible, and as soon as it is finalized. We will also be urging our members to become compliant as soon as possible. Therefore, we urge CMS to utilize remittance notices, carrier bulletins, and any other means possible to educate covered entities regarding the form and other assistance in achieving compliance in an expeditious manner.
We look forward to working with CMS on the form and the instructions. We hope the end result will be an easy process, and a simple, limited form so that all covered entities who will need an extension, can submit the forms as easily and simply.
At this time I would be pleased to respond to any questions you may have.
DR. COHN: Jean, thank you very much.
Our next speaker is Tim Wilder from the American Association of Health Plans. Good morning.
MR. WILDER: Thank you. Good morning. My name is Tom Wilder. I'm with the American Association of Health Plan. I want to thank Dr. Cohn and the subcommittee for the opportunity to provide testimony today on behalf of our member health plans regarding the Administrative Simplification Compliance Act and the model compliance form.
I also wanted to thank Rob Tennant for his very hard work on behalf of WEDI in developing this model compliance form. I am a member of the WEDI board of directors, and did serve on the task force. And I recognize from participating in all of those meetings and conference calls, the very hard work that Rob did to not only bring consensus among a very diverse group, but also more importantly, to get a consensus and reduce it to paper in the form of this proposed model compliance form.
The provisions of the Administrative Simplification Compliance Act are fairly straightforward. As you are aware, covered entities have an additional 12 months until October 16, 2003, to come into compliance with the electronic transactions and code sets rule. Covered entities that want to extend the implementation date must file a compliance plan with the Department of Health and Human Services.
This compliance plan should include a summary of the reasons why the entity will not be in compliance as of October 2002, a budget, scheduled work plan, and implementation strategy for achieving compliance by October 2003, whether the entity will use a contractor or other vendor to assist the entity with coming into compliance, and a timeframe for testing that begins no later than April 16, 2003.
In addition, the Department of Health and Human Services is directed to develop a model compliance form that entities may use if they wish to notify the department of their compliance plans. And once that plan is filed with the department, whether is it through the department's form, or on the covered entity's own behalf, then the covered entity can use the new implementation date of October 2003.
There are several points that we think that the department should keep in mind in developing model compliance forms. Many of these points have been brought up on behalf of other organizations. But obviously, we need to keep it simple, make the form easy to understand and to fill out.
As Rob pointed out, this is a situation where one size does fit all. The more complicated the form is, the harder it is to fill out, the more likely a covered entity is just going to adopt their own compliance plan, and the department will be inundated with paper.
The department needs to set up a system to acknowledge the receipt of compliance plans. As was mentioned, what would probably happen is once you fill out the form on the Internet, you would get an immediate email response or a faxed back response notifying your receipt. Because it is likely that a number of covered entities will also mail in compliance plans, the department needs to set up some kind of mechanism to acknowledge the receipt of those plans as well.
The department should allow one person to file compliance plans on behalf of multiple entities. For example, a parent would be able to file on behalf of various subsidiaries or related corporations. Covered entities should be given the option -- this is not a requirement -- but the option to designate as part of their implementation strategy, that they may be extending some transactions by October 2002, and others by October 2003.
I want to make this point very clear, however. The law, as I mentioned, is very straightforward. I think once you file your compliance plan, you will get an extension for all transactions. There are some covered entities though that may want to say again as part of their work plan or implementation strategy that they will have some transactions that may be done sooner than others.
And I think though above all, there is one point that we should all keep in mind, and that is the fact that the model compliance form is really not the important part of this legislation. The important part of the legislation is the fact that folks are given an additional period of time to get ready to implement the transactions and code sets rule.
In fact, this form in a sense kind of reminds me of a situation I encountered several years ago when I worked for a state insurance department. One of the projects I undertook was to look to see if there were any parts of the insurance code, or any of our regulations that should be deleted because they were no longer required. And I went up to the property and casualty division and they had this big file cabinet that was jammed full of papers that they had received in the form of annual reports from insurance companies.
So I talked to the head of the division, and I said, why do you collect these forms? And he said, well, it's required by the law. Well, what is in the form? Well, it's in the statute. The statute says what's in the law. Well, how often do you get them? Well, insurance companies have to file these every year. Why do they file them? Well, the law says they have to file them.
How many years have you been collecting this form? Well, ten years. In that ten years, have you ever looked at this form? Well, no, we just check off to make sure the companies send it in. Well, in that ten years has anyone in the public come in to look at the form? No, no one has ever come in and looked the form.
And to me, that's what this model compliance form is, except multiplied by hundreds of thousands, if not millions. It is important in the sense that a covered entity needs to be send the form in to let the department know that they are getting an extension. And there is some information in there that I think NCVHS will have an opportunity to take a look at. But again, people need to spend their time getting ready to implement the rule, and not filling out this form.
As I said, the issue with the act is that covered entities have an additional period of time. I think that the Department of Health and Human Services needs to get this model compliance form up on their Web site as soon as they can. I think the department also needs to get the rest of the HIPAA rules out in final form as soon as possible. Our plans are very concerned that we still do not have final rules for the identifiers, for security, for enforcement, for claims attachments. And that work needs to be speeded up.
Both the department and the industry need to step up their educational efforts. While a number of covered entities are progressing to get ready for implementation, I think it's clear that there are some covered entities that are probably not even aware that there is such a thing as administrative simplification. All of us need to make sure that we educate our members. And I think that's the key role that the National Committee on Vital Health Statistics can help with those education efforts.
Again, the standard electronic transactions make a lot of good sense. I think they will help the industry, and help everyone make the process run smoother. But it only works if everyone is ready at the same time to implement the new standards. The act gives everyone an additional year to get ready. What we need to do, both the industry and the department, is to get our collective act together, and make sure that our members are ready to implement by October 2003.
Thank you, and I would be glad to answer questions.
DR. COHN: Thank you.
Theresa Doyle, Blue Cross/Blue Shield Good morning.
MS. DOYLE: Good morning. My name is Theresa Doyle. I am a consultant to the Blue Cross and Blue Shield Association. The association represents 43 independent Blue Cross and Blue Shield plans throughout the nation, and provides health coverage to 82 million or 1 in 4 Americans. BCBSA strongly supports HIPAA administrative simplification, and we are working diligently to implement final rules now promulgated by HHS regarding transactions and code sets and privacy.
On behalf of the association, I would like to thank you for the opportunity to be here today, and to offer our comments on the model compliance extension plan required by the Administrative Simplification Compliance Act.
Last year, BCBSA participated in an industry-wide coalition to seek an extension of the October 2002 compliance date for the administrative simplification rules for transactions and code sets. The coalition was comprised of over 40 national organizations. An extension of the compliance date was supported by a broad array of groups representing providers, payers, device manufacturers, state governors, county government, and Medicaid directors. These efforts culminated in unanimous passage by Congress of the Administrative Simplification Compliance Act in December of last year.
Like these other national organizations, BCBSA was concerned that the 24 month initial implementation period provided under the law was inadequate. Additional time was necessary to analyze the new standards and code sets, make necessary system upgrades, make business process changes, and importantly, test systems adequately with trading partners.
The cost and complexity of the rules and the standards they mandated, coupled with the fact that significant sectors of the industry would not have been able to meet the October 2002 compliance date necessitated a one year extension. In fact, an industry readiness survey published in January 2002 by Phoenix Health Surveys validated this point, concluding that the Administrative Simplification Compliance Act was not only timely, but was necessary.
We believe that the additional time will not only improve compliance, but will afford many organizations the opportunity to achieve through administrative simplification, rather than simple compliance with temporary band-aid solutions.
As you know, the new law requires covered entities to file a compliance plan with the Department of Health and Human Services in order to have the 12 month implementation extension. It's important to note that HHS approval of the compliance plan is not required. Submission of an extension plan will secure the one year extension.
The law requires a compliance plan to be submitted by October 16, 2002, and be a summary of an analysis reflecting the reason why the entity is not in compliance, budget schedule, work plan, and implementation strategy for achieving compliance, whether the entity plans to use a contractor or other vendor, and a timeframe for testing that begins no later than April 16, 2003.
The law requires HHS to promulgate a model form that covered entities may use, and to provide a mechanism by which compliance plans may be submitted electronically. While the straightforward one year extension may have been much easier to administer, the sponsors of the legislation wanted to insure a greater probability of compliance by October 2003, by requiring covered entities to analyze and consider the work that needs to be done to achieve compliance.
However, it is also important to the sponsors of the legislation, as evidenced by their statements in the Congressional Record that the compliance plans be "non-burdensome," and involve a "minimal reporting requirement," and that granting of the extension be automatic, and not discretionary.
In addition, the compliance plan is not intended to be a disclosure of all compliance activity, but rather a summary of select information on work to be completed. Entities may use the model form, or may furnish the information in an alternative format at any time prior to October 16, 2002.
We expect that most covered entities will find it in their interest to file for the extension. In particular, given the fact that HHS's modification of the final rule has been further delayed, there is little if any possibility that these modifications will go into effect for covered entities to implement them as a package, together with the original standards by October 16, 2002.
As a result, covered entities that do not file for extensions would be required by law to implemented the covered transactions as they exist with known flaws, and to adopt a national drug code, rather than the more widely used HCPCS J-codes. Then when HHS's modifications are subsequently approved, they would have to install the revised transactions and code sets.
And even if the final rule is promulgated this summer, there is little time for vendors to provide compliant software to covered entities, and for those entities to make the necessary system changes, and to test adequately with trading partners prior to October 16, 2002.
According to HHS transactions and code set rule cost estimates, there are almost 700,000 providers and non-employer health plans alone. And I reference AMA's testimony where they have, if I remember correctly, 850,000 physicians, which would bring this number even higher. And consequently, there could be hundreds of thousands of compliance plans filed with HHS.
With this in mind, we would offer these comments and recommendations. The goal should be simplicity. Compliance plans should be neither complex, nor so time consuming as to redirect any effort away from implementation of the rules themselves. This includes any accompanying instructions.
The model form should be concise, and not exceed the requirements of the law. This is not only appropriate, but it is necessary given the number of compliance plans that are likely to be filed with HHS, and the requirement that NCVHS analyze a sample of the plans filed. If the covered entities believe that the HHS model plan exceeds the requirements of the law, they may choose to file an alternative format. This will only impede NCVHS actions, and drain limited department resources, including staff time.
There should be one universal model form, which may be used by an organization to file on behalf of multiple covered entities. For example, a parent company could file on behalf of its subsidiaries, or a medical group practice could file on behalf of all of its physicians.
There should be a place on the form to indicate that certain information is confidential for the purposes of the Freedom of Information Act and NCVHS analysis, so as preclude disclosure of trade secrets, or commercial or financial information that is privileged and confidential. For example, using the Workgroup on Electronic Data Interchange document, a company provides confidential information under the "other" box under Section 2, entitled "Reasons for Filing This Extension."
It could be designated by the company as proprietary information, and thereby protected from public disclosure under the Freedom of Information Act. Similarly, if a physician used a Social Security number in place of the tax identification number, it could be designated as private and confidential. Otherwise, there would be an increased incentive to file on paper, so that confidential information could be so noticed.
Finally, there should be a mechanism that provides confirmation that compliance plans have been received by either electronic filing or by mail. Given the potential penalty of exclusion from Medicare for non-compliance, in addition to civil monetary penalties under HIPAA, covered entities will want a receipt.
BCBSA, along with other organizations has been working with WEDI to develop industry consensus on the model form. We are pleased that the industry is unanimous in its goal to keep it simple. We believe that the form approved by WEDI's board of directors on Thursday, January 31, meets both the intent of the law, and the practical realities of the situation.
However, a few suggested changes have been identified since approval by the WEDI board which we offer to you today for consideration. Modify the box in Section 2, Reasons for Filing for This Extension that reads "compliant but trading partner(s) not ready," to "compliant but trading partner(s) or business associate(s) not ready. A few covered entities may want to file, because they do not believe that their are business associated are completely compliant. This added language will minimize the need for covered entities again to use the "other" box for written text.
As discussed above, a section should also be added so that covered entities may indicate information that is considered a trade secret, confidential and/or proprietary for purposes of the Freedom of Information Act as well as disclosure to NCVHS.
We believe that an extension will go a long way towards increasing compliance, but it all begins with education. BCBSA has long advocated the importance of education, particularly with the transaction code set rules. Providers and state government in particular need to better understand the requirements of the law so that they can better assess their need, and the impact of the regulations on their day-to-day operations.
In addition, there are many myths surrounding the transaction and code set rules which need to be dispelled. This is BCBSA commissioned PricewaterhouseCoopers to prepare a report addressing several myths, such as providers only need to contract with a clearinghouse to achieve compliance; vendors can delivery HIPAA compliance to providers by software.
PwC report entitled, "HIPAA's Myths, Practical Realities and Opportunities: The Work Providers Need to Perform For Standard Transactions and Code Sets" has been well received. The document was presented to the NCVHS Standards and Security Subcommittee at its hearing in December by Jeff Fusile. We hope that CMS will integrate aspects of the document into their provider education program.
BCBSA strongly supports administrative simplification as a way to make the current health care system more efficient and user friendly, and believes that the extension will greatly insure a smooth transition. We thank you for the opportunity to testify before you today, and we would be pleased to answer any questions that you may have.
DR. COHN: Theresa, thank you very much.
Our next presenter is George Arges, American Hospital Association.
MR. ARGES: Yes, thank you. Good morning. I am George Arges, senior director of the health data management at the American Hospital Association. The AHA represents nearly 5,000 member hospitals, health systems, networks, and other providers of care.
I am here today to discuss hospitals' reactions and concerns related to the Administrative Simplification Compliance Act, H.R. 3323, as well as recent efforts around the development of a model form for requesting an extension to the transaction standards compliance date.
As you may know, the AHA recommended that the Department of Health and Human Services use its flexibility in enforcement to address providers' concerns about meeting the October 16, 2002 compliance deadline, rather than supporting legislative efforts to delay implementation of the transaction standards and code sets.
We believe that standardization will lead to significant efficiencies and savings, and that further delays in implementing the standards for electronic transactions and code sets could undermine these important objectives. Many of our members told us that they would be ready to meet the October 2002 compliance deadline, and that they were expecting to apply the savings from standardization of transactions to help fund the implementation of HIPAA privacy and security regulations.
However, we also heard from others that were concerned about completing their information system modifications to comply with the standards by the required deadline. The AHA policy recommendation urging HHS to use its enforcement discretion was carefully crafted to insure that appropriate incentives for the entire health care field to expedite implementation of the electronic transaction standards were preserved, while allowing flexibility for those hospitals that might need additional time to achieve full compliance.
The passage of H.R. 3323 presents organizations with the opportunity to seek an extra year to implement the transaction standards and code sets if the file a request for an extension to the original compliance date of October 2002. Somewhat troublesome, however, are the punitive measures included in the legislation. These measures will apply to organizations that fail to meet the implementation timeframe, and did not request an extension.
The punitive measures, however, will only apply to two of the three covered entities, health care providers and health plans. Since both of these entities can serve the Medicare program, they are at risk for being non-compliant, and their failure could lead to being barred from participating with the Medicare Program.
These punitive measures, however, will have little or no effect on the other covered entity, the clearinghouses. Yet, they can wreck havoc for the health care providers and the health plans that may want to move forward with the adoption of these standards, but find it difficult to do so, because the clearinghouses are not ready.
While H.R. 3323 provides additional time for those who may need it, it also threatens to harm those ready to move forward with implementation. Organizations that believe they are ready, may find that their application of the transaction standard fails with some of their trading partners. Consequently, they may face the penalties of harsh sanctions, because their efforts towards compliance did not meet a yet undefined test criterion for successful application of the transaction standards.
To protect hospitals, the AHA is likely to recommend that all providers file for an extension, even though they believe they will be ready to start using these standards by October 2002.
With respect to the initiative to design a model form for requesting an extension, the AHA supports the Workgroup for Electronic Data Interchange form recently approved by the WEDI board. The WEDI board reviewed the recommendations from the WEDI task group assigned to this initiative. The task group, of which AHA was a member, was composed of a cross-section of the health care community, and therefore was able to accurate gauge the reaction of the context of the form, and reach consensus.
Most participants generally held similar views about achieving as much simplicity as possible in the form's design. To further bolster provider reaction, the AHA hosted a meeting in our Washington offices, inviting representatives from WEDI, the Association for Electronic Health Care Transactions, the Center for Medicare and Medicaid Services, and other provider and patient organizations to review a draft of an earlier WEDI form, and to come to closure on any of the issues that may be a stumbling block.
We believe that the recently issues WEDI form satisfies the requirements called for in H.R. 3323. The AHA will now work to inform our members of the form's existence, and to insure that those hospitals that need to file an extension will know what they need to do, and by when. The AHA's HIPAA Web site will link to the form, and provide additional instructional materials to aid hospitals in their completion of the from.
There remain two sets of issues regarding the implementation of the administrative simplification provisions of HIPAA that must addressed if the objectives of insuring that HIPAA's administrative simplification provisions achieve their hoped-for potential, and thereby benefit American hospitals.
Recently, the AHA sent a letter to the Sec. Thompson outlining our concerns that delays in issuing the remaining regulations for electronic transaction standards create significant problems in meeting the compliance deadline. In our letter, we urge HHS to expedite the department's rules on the administrative simplification provisions that support the final electronic transaction and code set regulations. To date, many of these rules have not been issued, even in proposed form.
We also noted that there appears to be little or no forward movement on the other critical decisions, including the expedited release of health plan identifiers, frequency of updates for clinical code sets, the development of compliance and certification testing software, and steps to improve the coordination of benefits process. We urge HHS to address these other unresolved implementation issues to facilitate timely compliance.
Finally, we noted that there was an opportunity for HHS to take certain steps to assist health care providers in realizing the full savings and efficiency potentials implicit in the enactment of HIPAA through rulemaking or guidance to facilitate the prompt and accurate payment of claims. Copies the AHA letter to Sec. Thompson addressing these issues can be provided to the committee.
I would like to thank you for the opportunity to present our views today on H.R. 3323, and on the form to request an extension. And I will be happy to answer any questions after the other panel members provide their testimony.
DR. COHN: George, thank you very much for your testimony. Also, if you would send us a copy of the letter that you sent to Sec. Thompson, we would appreciate it. Do you have it? Okay, thank you.
Our last testifier is Mark McLaughlin from McKesson.
MR. MC LAUGHLIN: Mr. Chairman and members of the Subcommittee on Standards and Security, thank you for the opportunity of allowing McKesson to discuss with you, the issues related to the model compliance extension form for the transactions and code set regulations.
As a member of the Association for Electronic Health Care Transactions, AFEHCT, we believe our concerns to be representative of other like vendors in the health care industry. McKesson has a diverse array of information systems solutions, including a transaction processing clearinghouse, which of course is a covered entity. We expect to roll out HIPAA solutions for the transactions and code sets early this year.
It is important to note that we have significant concerns regarding the release of the pending NPRM for transactions and code sets, and are not confident that this NPRM will be released in time to satisfy the 180 day modification requirement that is imposed by the legislation. Having made this caveat, the following statements are provided in anticipation and the assumption that the NPRM will in fact be released on time, and our concerns were for naught.
McKesson's clearinghouse as a covered entity, will be ready to send and accept HIPAA compliant, currently supported transactions prior to October 16, 2002, the initial compliance date, and will not need to file for an extension as allowed under Public Law 107-105. However, because of the integral relationship between the clearinghouse and the payers' ability to accept and send HIPAA compliant transactions, we believe we may be forced to file for such an extension as a result of trading partners or payers who may not be ready by the October 16, 2002 initial compliance date.
One of the critical pieces of P.L. 107-105, the Administrative Simplification Compliance Act, is the assignment of a timeframe for testing. As stated in the law, testing for the designated transactions and code sets must begin not later than April 16, 2003.
WEDI-SNIP has published two white papers, "Business-to-Business Testing" and "Transaction Compliance and Certification" on the issue of testing, and copies of those were provided to this subcommittee prior to this testimony. As noted in these papers, there are several levels of testing that must be provided in order to meet HIPAA requirements. McKesson believes that it is important to clarify the testing level that covered entities are expected to begin on or before April 16, 2003.
Two of the higher level definitions of testing include internal and external testing. Internal testing includes initial and repeated system debugging called unit and model testing, compliance testing to verify the information is sufficient to comply with the element requirements of the HIPAA standard, and beta testing once the systems are installed at a customer site. These tests are critical to the process, and we believe should be performed in early 2002.
External testing includes trading partner testing, which is necessary to insure proper connectivity between trading partners, data integrity testing to verify the trading partners are transferring the appropriate elements of the business need at hand, and stress testing to validate that the trading partners' systems have the capability of handling the load of the new transactions.
The necessity for specifically depicting which level of testing that should begin on or before the April 16 timeframe is clarified in the scenario provided below. McKesson provides information solutions to thousands of providers, including hospitals, physicians, home health agencies, and payers. Each provider and/or payer entity is installing, or will need to install the upgraded software that McKesson provides for HIPAA data content requirements.
Rollout of this software and implementation by the providers and payers on average takes several months to complete. McKesson's clearinghouse has connectivity to thousands of payers. Testing with each payer is a critical component necessary prior to submitting production transactions to the payer. Each test cycle with a single payer can take weeks, or sometimes even months.
The variance in time is due to many factors, including the size of the payers's work queue for other trading partner tests that have been submitted, the number of resources that they committed to this important task, and the internal methods by which they perform the tests. Currently, the McKesson clearinghouse is experiencing difficulty in finding payers who can exchange HIPAA-compliant transactions. Those payers who are willing to begin testing with HIPAA-compliant transactions will not allow us to go into production for an undetermined amount of time, even after that testing is completed.
Given the very real situation mentioned above, you can see that it would be critical for external full trading partner testing to begin in 2002, and not later than April 16, 2003. Internal testing as noted above, we believe should be started much earlier, perhaps in 2002, in order to allow for the full trading partner testing to begin not later than April 16, 2003.
We believe that further guidance from HHS is necessary to lead the industry toward early external testing, and to provide clarity and direction to covered entities that internal testing should take place as early as possible in 2002.
I would be happy to answer any questions. Thank you for the opportunity.
DR. COHN: Okay, thank you all. That was a very interesting set of issues and opportunities that you bring up. I want to thank you for working so hard to develop a model compliance form. You have our appreciation.
Are there questions from the subcommittee members?
DR. ZUBELDIA: Thank you for the presentation. I think it has been very rewarding to see that you are all in agreement on how to do this. And that is pretty much following the recommendations from the letter to the DHHS and the secretary on July 29.
A concern that I have from today's presentations, and maybe all we need to do is just find the proper way to do this is that -- and first, let me preface it by saying that I agree that a covered entity that has multiple subsidiaries or multiple covered entities within the same corporate umbrella should be able to file just one form for all of them.
The concern that I have is that there may be situations where a third party is filing on behalf of a covered entity. So as a clearinghouse, filing the extension for all the members or all the providers that use the clearinghouse. Or a member filing the extension for all their clients. And I think this would be a problem.
Do you propose some way where we can prevent that from happening, and still allow covered entities to file together with one application?
DR. COHN: Maybe I'll start by commenting on it. I actually think that there is probably a very big difference between organizations that are a single organization that may have different subentities, as in physician groups, and a vendor or clearinghouse. I'm not a lawyer, and there may be some lawyers in the crowd here who can assist with that. But it seems like there ought to be some way to make that distinction.
Does everyone here think that that's a valuable distinction to make? I see heads nodding yes.
MR. ARGES: This is George Arges. I was concerned with the way the punitive measures were laid out in the sense that it applied mostly to providers and health plans, but the clearinghouses, who basically don't hold necessarily contracts with the Medicare program, aren't at risk. And many providers and health plans rely on the clearinghouses to basically help them meet the standard's capacity.
So in as much as there is some uncertainty about that, I mean we basically are saying to the providers, file for an extension whether or not the clearinghouse tells you they are ready or not ready, just to protect yourself.
DR. ZUBELDIA: Let me follow-up on that. The concern is more than if a clearinghouse or a vendor or trade association for that matter, was to file on behalf of all their members, then the members would not know what is it that they need to do to get HIPAA compliant.
And the form can raise the awareness, and makes them aware that there is something that they have signed up for, and that is HIPAA-compliant by a specific date. And I agree, it should be very easy to say you can only file for entities for which you have corporate authority of some sort. But I think that needs to be included into it.
DR. COHN: You mean you're supporting that position?
DR. ZUBELDIA: Yes.
DR. COHN: Okay.
MR. SCANLON: I think we're looking for covered entities filing the compliance extension plans. The question is at what level of aggregation. And this doesn't raise any new issues, because you have got to deal with the definition of covered entities already. The trade association, I don't think anyone is envisioning would be submitting -- well, that would not be a compliant extension.
MR. BLAIR: A couple of questions. Jean, I like the suggestion that you made that the name of the form be considered I think you called it a HIPAA extension form. Is that correct?
MS. NARCISI: Yes, that is correct.
MR. BLAIR: When I went into my doctor recently, since you are representing the AMA, they were so preoccupied with the HIPAA privacy, they didn't even know about the transaction rules. Is it your opinion that it would be productive or worthwhile if were to define it as the HIPAA transaction extension form, or transaction and code set, to distinguish it so that they don't automatically assume that this is related to privacy?
MS. NARCISI: Yes, I think that would be an excellent idea, because you are right, it does just apply to the transaction and code set. And I believe that most providers are more concerned with the privacy regulations than they are with the transaction rules.
DR. COHN: I'll make a comment or two, and ask a couple of questions. I was busily making notes, and I think there is enough paper here that I could easily get lost in all of it. But there were a couple of issues that I heard about that I think are of particular concern to the subcommittee and to the NCVHS.
Obviously, our role in all of this is to make sure that the actual HIPAA implementation goes well. That it is a successful implementation. That it's not unduly burdensome on the industry. We are also concerned to make sure that the one year is used in a productive fashion, and it isn't just a delay where people get rid of their HIPAA teams, and then sort off about this time next year with trying to come up with groups and organizations and plans to meet the new deadline, and then suddenly discover that they don't have time to do that.
We have also been given some responsibilities under the compliance act which obviously includes advising on the model compliance form. But at some point when you get all these forms back, we are going to have to figure out some sort of an analysis of these compliance forms, and help use it to help assist us in identifying where are the problem areas, and what sort of best practices can we publish either ourselves, or through other entities to help identify all of this. So I'm just sort of framing our perspective on all of this stuff.
Now having said all that, I saw a number of issues, (A) and I think Kepa has already brought this up is the issue about that somehow units need to be able to easily file for an extension, and yet we also need to know who is filing. So I am from Kaiser Permanente. We have in one of our medical groups, 3,500 physicians. You certainly don't want to have 3,500 forms. You also want to know that all of those physicians are covered, and the other organizational units associated. So probably there needs to be some way to accommodate those sorts of entities.
B, one thing I didn't see on the form, and I bring this up for a question. I don't know whether it is a required field or an optional field. One of the things if I get this form back and start looking at hundreds of thousands of forms, hopefully by a computer-generated format, would to be to know if there were any particular problems any of the code entities are having with any of the particular transactions.
And in reality, at least within my organization, there are multiple different systems, multiple different implementations under the umbrella of HIPAA. And all of it goes from membership and enrollment, disenrollment, to claims, and so on.
So the question is, for the subcommittee I just say that it would be very helpful for us to know if there are particular transactions that for whatever reason, there is a particular problem. And I do need your input about that one to see if it makes sense as either a required question or an option question with a Y. And are you having problems with a particular transaction? And then a pretext field that says why are you having problems with this one?
MS. GREENBERG: You could list them.
DR. COHN: Yes, I don't know how we would handle it. But I'm curious to see if that's a good idea, that sort of a question.
C, you brought up the fact that we all need to work together to encourage electronic transmission and receipt of these. I was trying to figure out how to handle these in paper format. It's going to obviously make it very difficult for us to do any sort of analysis, no matter how much we may want to do it. So we your help on that.
D, you talked about educational programs. And finally, I was struck by a number of you talking about your concerns that we were not going to get out the NPRM, even with the six months prior to October 16, 2002, which all but guarantee that everybody in the health care field is by definition, going to require a delay, no matter what anybody else may say.
And I think at this point that is a likely possibility given that we don't have an NPRM. It's going to take 60 days for the NPRM likely for comment, and then a final rule come out.
MS. GREENBERG: Thirty days.
DR. COHN: Well, we are February 6. It comes out tomorrow for 30 days.
MR. ARGES: March 25 is the release date we have heard. March 25 is supposed to the release date.
DR. COHN: If it was on the Internet, I'm raising my hand. It sounds good to me. I guess I'm just sort of working back in terms of the dates, and just wondering if the whole industry by definition is going to be required to file an extension just because of the timeframes being proposed. And regardless of what anybody says, that a fait accompli.
I have said a lot of things here, but I would ask for our panelists to comment.
MR. TENNANT: You have raised an excellent point with the issue of the different transactions. Obviously, somebody may be fully compliant with the 837 quickly, but lagging behind on claims status or something like that. The task group actually looked at that, and in one of our early drafts we had a listing of all the transactions. We discussed whether or not we should sort of break out each one to find out what the problems were, how were they doing in terms of compliance, and the form became longer and longer and longer.
So the consensus was well, that really wasn't part of the mandate in the law, so we scaled it back. That's not to say we weren't cognizant of that concern. Maybe there is some modification. Maybe there could be a one line question is there any particular transaction you are having the most trouble with? And that might be helpful to the subcommittee.
MS. NARCISI: The other thing, when were discussing whether we should have the transactions listed on the form, for physicians, not all of the transactions will be used by the physicians. They don't apply. So you will have to include quite a bit of explanation I think in your companion document about those transactions. So I think just to simplify it more, that is why we eliminated that detail on the form. But it makes sense that you would want to gather the information about it.
MR. WILDER: Yes, I would agree with that. I think there is certain information that NCVHS may want to gather, but I think you need to distinguish between what you need to gather, and what needs to be on this form. So there are a lot of issues that you may want to look at that don't necessarily need to be on this form or in the instructions.
For example, this whole issue about testing. I respectfully disagree. I don't think the law says anything about external or internal testing. It just says testing. And so while you may want to encourage folks to have a certain kind of testing done by a certain date, I don't think this form is the place to raise that issue.
MS. DOYLE: Theresa Doyle. We agree absolutely on the issue of the testing. I think as a matter of fact, the law says that your compliance plan has to have a timeframe for testing which begins no later than April. Having said that, it could be both internal and external. I think it was a nod that testing was very important, and whether it was internal or external. And that you should at least make some time for it in putting together your compliance plan.
Having said that, I also agree, we have to keep these forms very simple. Again, because people have the option a form that is not the model form, I think we have to constantly come back, is this required by the law. And if it's not, I would say don't put it on there, because what we don't want, it's just going to further impede, as we said on our testimony, the work that NCVHS has to do if we get 700,000 different formats of the information, because the model form was inappropriate.
I think, in kind of talking where Tom was going with this, is that not all the information you may need, you're going to get off this form. That's why I think what you do that the NCVHS committee is probably going to have to have hearings that would gather additional information which you cannot get on the form itself.
Perhaps just if you look at the notice that provider organizations almost unanimously are checking a similar box for why they are filing the extension, well, maybe you might have to have a hearing as to why is it that it is predominantly the provider community that has box, and not just the payer. I'm just saying that that's the type of information maybe that would lead you to a hearing where you can get more information instead of requesting it on the document.
MR. MC LAUGHLIN: Regarding the testing, I agree that the legislation does not make a differentiation between external and internal testing. And what we are really asking for is a clarification, because our fear is if it's left up to covered entities to interpret for themselves, if they just begin their internal testing at that time, by October 16, 2003, you are going to have a lot of people who aren't ready to begin trading partner testing, and we're faced with another delay because of that. And that's our fear.
DR. COHN: George, do you have any comments?
MR. ARGES: I think some of the people made the same comments that I would. I think the form ought to be kept as simple as possible, and not make it burdensome. And I think the task group basically went through some of the very same issues as to whether to include details about which of the transactions, that sort of thing.
And in terms of testing criteria, I don't think the form needs to be explicit about internal/external. I do think there needs to be some guidance in terms of what testing means. And that ultimately in the end, one has all levels of testing in order to be successful. And that would be very helpful.
MR. SCANLON: Can we take from the discussion this morning, which has been very helpful, that there is largely agreement of the industry that this is more or less a model that everybody can live with? Is there any major group that would have problems with this that you are aware of?
MS. NARCISI: No, as I said in my statement that AMA definitely believes that the model form that was developed is acceptable. However, I want to stress that I really think that you need to have focus groups with all of the different covered entities that will be using it. Not only will it help you to determine if the form is appropriate, but you will able to gather some of that other information that you are concerned about.
Maybe you are not going to include it on the form, you should include it on the form. I think that you would find it helpful. We did that when we were considering changing the HCFA 1500, and we got excellent information.
MR. SCANLON: A follow-up, Simon. The NCVHS is directed to look at a sample of the compliance forms that are submitted. And to do that I guess most intelligently, it probably would make sense, Simon, to stratify as you are suggesting, in terms of what kind of a covered entity is filing the submission.
And the list here on the model form is simply the three major covered entities. Did you think of a more refined categorization? Provider groups include everything from the largest hospitals to a two physician practice. Is there some way to refine that?
MR. TENNANT: To address your first question, there was some I would say dissention in the task group. The vast consensus was on the form. There were some individuals who felt the form was still too complicated for the very small providers. There were some that felt that the form should have a lot more information, because it was an opportunity to find out what the industry was doing. But I think those two camps were convinced to support what we eventually came up with.
The other point, we did in an early draft, come up with a breakout of different types of providers: hospitals with X number of beds; providers with less than 10 full-time equivalents. And again, the task group said that's just getting too complicated. There is not much to be gained by breaking it out. And somebody usually knows that they are a provider or a clearinghouse or a health plan. So we did discuss it, and there was some feeling that it should be broken out more, but the consensus was no.
MS. GREENBERG: There are a few things. Back on this testing issue, I think the form does mention under phase 3 implementation, it asks whether you have completed initial internal software testing. So I think that kind of indicates that the internal testing is not necessarily how you score. So I think that is good if this is a concern. That people realize that it's not just internal testing.
The other question I had. I, myself, was somewhat concerned about what was intended from the point of view of budget. And it looks like the form has just basically said do you have a budget or don't you. And do you have sufficient resources. They ask that a few times. Is there a strong comfort level that that's all that was really expected by the Congress?
I hear people having to submit real budgets is appalling, frightening. But on the other hand, this is pretty minimal. It really isn't a budget at all. It just asks do you have a budget. Is there any sense of what was expected?
DR. ZUBELDIA: Marjorie, I have that concern too. The act says such plans will be a summary of the following. An allowance that reflects the extent to which, and the reasons why a person is not in compliance. The plan has to have a summary of the budget schedule, work plan, and implementation strategy. It's a summary of those things, not an indication of the existence of one, but a summary of it.
And I think a summary of the budget would be the bottom line. How much money are you going to spend in implementing HIPAA. That's a summary of the budget. I think it's very risky to ask for something like that. I don't know whether we need to get to that extent or not. So maybe this is a good compromise where it's not a summary of the actual budget, but just the existence of a budget.
MS. GREENBERG: I would have to say that the way it's laid out now, I don't really think there is anything here that would qualify as proprietary, which is probably good, because that would be another level of complication to have to allow proprietary information, et cetera. So just from looking at it, other maybe somebody wouldn't want to know that they hadn't achieved executive support. It looks to me like this would not be problematic or proprietary.
I don't know whether there is any risk at all. If the department is satisfied, Congress coming back and saying, this doesn't meet what the intent was. They said they didn't want us to burdensome, it's probably okay.
DR. FITZMAURICE: Could I follow-up on Marjorie's comment? There may be the possibility that a sample of people could be called back, and you could ask them some more detailed questions that would bring which sample that is called to get some additional information, even it if it proprietary. It doesn't burden everybody who files a report. That's a possibility you might want to consider.
MS. DOYLE: I pressed the issue of proprietary information. I can't anticipate what people will add to the "other" section, the issues where they can so list what is not check box. Or if any entity chooses, and uses a Social Security number, and while certainly it was not DHHS's policy I assume, to release that, what we had raised in our testimony is the opportunity. There is knowledge that something perhaps is proprietary, as you would, I understand, when you do send information in.
It's just another way of safeguarding some information that you may put in there, and it's easy. As I understand, it's done readily when you send in sort of a paper copy of something. You can say you consider this to be proprietary and exclude it under the Freedom of Information Act. That's all we were saying, is just have another check box so whomever is flipping through that, if they see that checked, they can look and see if there was something that was identified that does not need to be released to NCVHS or the public, or should not.
MS. GREENBERG: You wouldn't want a check box with every single item. That's not an efficient way of doing it.
MS. DOYLE: I agree. It would be something as an overall.
DR. COHN: Is this on the same topic? Okay, Robert.
MR. TENNANT: Maybe just on Marjorie's point about the issue of budgets. We certainly discussed that at length. In several renditions we had a breakout of $0-5,000, up to $2 million. And then the question is, well, what use is that information? If you get information that says somebody spent $10,000 and somebody spend $5 million, it doesn't really tell you much, especially since we are not breaking out the entities into small providers or whatever.
So the question was well, what use would the NCVHS have with a budget question? And in the face-to-face meeting we had a good discussion, and the consensus was well, you want to find out if they are having trouble achieving the budget, because that might be an area of education that the NCVHS could hit on, or CMS.
DR. FITZMAURICE: I just wondered from Theresa's comment, my understanding from all the testimony was that there is nothing on this form that would be considered business confidential or proprietary or particular to the Freedom of Information Act. Is my understanding correct, at least from your understanding?
MR. ARGES: With the exception of one area. It's the "other" where you can put in briefly explain. It's the briefly explain box that can be potential a potential for proprietary information.
MR. BLAIR: Actually, I have one question on this budget issue, and then I had another question. Should I save the other question until later, or are we concluding this?
On the budget issue, Rob, I'm very grateful for the work that WEDI has done with the rest of the industry with respect to coming up with this draft HIPAA extension form. Did you consider on the budget issue whether to ask has the budget been approved, or has the budget been appropriated? You wound up with just simply saying is there a budget. Was there discussion about these other options?
MR. TENNANT: That's a good point. Again, we tried to keep it as simple as possible, because just the definition of budget is confusing. Is it a budget that has been asked for, one that has been approved, one that has been spent? It's very confusing even at that level.
So I think what we are trying to do is ascertain from the submitters what the level of difficulty was. Was there trouble getting executive support in the budget, and that type of thing. And again, always with the recognition of keeping the form as simple as possible, making it so they don't have to go to the lawyer to find out what to fill out there and things like that. But that's a very good point, though.
MR. BLAIR: Okay, the other question is a different topic.
DR. COHN: Okay, are we ended on this budget topic?
MR. SCANLON: I think the interest is not so much the amount, as the fact that the budget planning and process has begun. And it is more an issue of have you looked at the requirements, have you costed it out, and are you now requesting -- in that process. You don't really need the amount. It would not be helpful, and it would make everything sensitive.
DR. COHN: Jeff, onto the next question.
MR. BLAIR: One of the areas that is of concern to me is that -- and I'm trying to see if there is some way we can get around this -- Jean, when the AMA had discussions about this, one of the recommendations apparently was that there was a need to be able to respond in a hard copy format. And I'm sure you probably struggled, and that that was not what you wanted to do, but you felt like it was necessary.
I would like to ask you a couple of questions on that, because I would like to see if there is some way we could if not eliminate having hard copy responses, at least reduce it as much as possible. One of the things was that if a solo or small group practice doesn't have a computer, then they don't really have to be part of this. They could continue in hard copy form. And if they do decide to purchase one, then of course then they would need to become compliant. So my thinking was that -- is that not correct?
DR. FITZMAURICE: Jeff, I think if they send their paper to a billing service, the billing service converts it to electronics. They are covered, even if they don't have a computer in their office.
MS. NARCISI: That's right. And we did find that through even our focus groups that we had for the 1500 claim form. That the sample that we had pulled together, while it didn't fit quite right in some of the typewriters in these offices, that they do send them off to billing services and have them sent in electronically. So we even talked about it in our WEDI discussions, and it would be great if it could all be handled electronically, but we do believe you will be getting some paper. And that means you will probably have to respond with paper.
MR. BLAIR: Then let me ask this. I'm looking for some way to at least minimize or reduce this somehow. What I'm thinking of is whether the AMA might be able to assist us in identifying -- well, I guess that's not going to help anyway. I was thinking that it would be solo or small group practices where there might be paper submissions, and if we could somehow contain it to that group. But I guess I'm still struggling on how to do that, so let me give up on that.
DR. COHN: Jeff, maybe I can help rephrase your comment, rather than trying to give the answer. Maybe we ask them if there are any suggestions they have about ways to think this through. Jean, why don't we start with you, and then Robert Tennant.
MS. NARCISI: We would happy to help you in any way possible. I don't know if there is any way around this paper dilemma, even though this applies to HIPAA paperless claims and so on. On this extension form maybe one of the goals will be for a physician's office or a small provider office to start sending claims electronically. Maybe they don't do that.
So for you to just require it sent in electronically, I think that would be -- the other thing too you have to think about is that we have done some research and physicians' access to the Internet, because you are supposedly going to have to have some kind of a Web-based online form.
And the percentage of access to the Internet is very high for physicians, but that doesn't mean that it is in their office. Usually they have access at home or in some other location besides their office. So in a typical physician's office, they may be computerized and have a billing system, but they may not have Internet access within their office.
MR. TENNANT: Yes, I agree with Jean as well. And I think really the key is to make the electronic form as palatable and easy as possible. And I think one of the ways to do that is to advertise it through groups like the AMA and MGMA and AHA so their members know that not only can they go to the electronic format, but they will also be able to have a lot of ancillary documents there. So it's an encouragement for them to go to the Web site and fill out the form, because they will be able to learn more about what they need to do as well.
And WEDI's work group suggested that if you are going to go to a written or paper document, make it scanable, so it is at least easy on the back end to convert it to electronics.
MR. AUGUSTINE: Jean, I just kind of want to respond to what you said. It's interesting, there were some studies that just came out that said that over 90 percent of physicians have access to the Internet at home, but less than 50 percent have access at work. And Rob, you have been very thorough with this. I just wanted to ask, have there been thoughts about whether or not there is proprietary information on the form using SSL technology?
Because there are some physicians I know that won't put information into a form over the Internet. Maybe people could request information from the Freedom of Information Act on the back end, and not necessarily have it available to everyone on the front end. Have there been thoughts about that?
MS. NARCISI: From the AMA's perspective, the study that you were referring to I think was the AMA study. We have done that for the past several years on Internet use. And that is one of the biggest barriers for Internet use is any detailed information that will be out there, and if it's not secure. It's not just credit card numbers, but any other detail about them.
So that is one issue that we didn't talk about in our WEDI discussions, but I think you need to consider it. I think you need to consider the security section of it, and make sure that whoever you have designing your application is qualified to handle that.
MR. TENNANT: That's a great point, and it gets even worse if you think about it. I think a lot of entities are going to do both. They may submit electronically, but they are going to be so worried about being excluded from Medicare, that they are going to courier over some form. Again, this might cost them $50, but the problem at the back end by being excluded from Medicare is so great, that they will take any opportunity to make sure they get the extension.
DR. COHN: Marjorie, is it on this point?
MS. GREENBERG: There's probably no way to avoid some paper forms. And as you said, the scanable may be doable. I'm just wondering if AHA and AMA could kind of work collaboratively so that I would think all hospitals, but maybe not, have Internet access? It may be providers who don't have it in their office, but some kind of arrangements that they could do it from the hospital.
MR. ARGES: I'm sure that we are going to make every effort to try and inform our members about what they need to do in terms of completing the form, if they choose to do so. We will make it available in terms of our Web site, or at least link them to where the form is at to comply with it.
In terms of other services and follow-up, actually, we probably will be meeting with several of our members as part of an advisory team that we have to kind of discuss options, and look at what the best method might be. I do agree with what Jean had mentioned too in terms of notice in the remittance notices prior to the filing date, just to kind of remind the providers that this is an option made available to them.
And it might perhaps include a sample of the paper form, but it is probably best to try and encourage them to go electronically. It might be something too where they can go to a public library if need be, where they can access to an Internet, and just do an easy filing on that point there.
But we did look at developing an easy form of this form. This is about as easy as you get.
MR. AUGUSTINE: Rob made an interesting comment that I hadn't thought about yet, but dealing with surveys, which I have administered in the past, if you give them two routes of administration, you will get likely from some people, two in return. And there are times, you would think it wouldn't happen, but it does, when those two surveys from the two different methods don't agree. And then you have the problem of which one is correct. That's why having one route of administration would definitely be recommended here if at all possible.
MR. SCANLON: I guess what we learned is that even when we are talking about e-government, that in the earlier comments on the regulations, the majority of folks send these things in paper. It's psychological and it's legal, and everyone wants to see it, and everyone has to clear it. So I wouldn't be surprised at all if the majority are paper, just for legal reasons. It's too important for most entities. It's psychological.
DR. COHN: Thank you for that sobering thought.
DR. KOLODNER: I'm Rob Kolodner from the VA. Thank you for your testimony. It's been very educational and enlightening.
On this issue of the electronic, what I'm hearing is there are really two issues. One is whether, and most likely an individual provider or a small clinic has access. If the AMA numbers are true across all of providers, not just AMA members, then the number of providers who don't have access to Internet, either at home or at work is actually relatively small.
So we don't necessarily need to resort to public libraries or other things, because in fact they have access to it in a place that is still fairly convenient for them, even if it's not in the office.
And then the issue is who handles the burden of getting it into electronic form. Whether it is sent into NCVHS and it's the government's burden to do something with it, or whether the provider who doesn't otherwise have access, has somebody, whether it's their billing service, or their child at home enter the data for them, or a neighbor.
And one of the other things that I didn't see in here is some of the things that you get on a variety of the commercial systems, which is not only do you get a receipt by email, but you also get a screen that says you have now submitted, here is your claim number. You can print that, so you immediately have something that gives you that confirmation, and you don't have to wait for the email. You may get that in addition. So there are some other ways of getting in that reassurance that Jim was talking about.
The other group though I think is still one that isn't covered on that. And that is individuals who feel that they just don't trust the information on the Internet and electronically, and they will say I want the option to have that.
Now, one of the questions is whether it is reasonable for those individuals say you've got that right. We won't force you to do it electronically, but there is a burden cost. Send in your check for $25 in addition to the paper. It just gives them that option of privacy, but also recognizes that instead of not incurring the burden and putting it on NCVHS, that in fact that's something you need to cover. I didn't know if that may provide some --
MR. BLAIR: Rob touched on this, and my question is that if for example when the AMA and maybe other professional associations that deal with -- maybe the American Association of Family Practice and others -- as they provide some education to your members, especially the small group practices, do you feel like it would be a compelling incentive with that education to point out that if they are able, if they do choose to enter the information electronically over the Internet, they will wind up getting an acknowledgement from HHS virtually immediately, within a minute or two, which they can print out acknowledging the fact that they have successfully applied. Is that a compelling incentive, do you think?
MR. TENNANT: Jeff, I think you are absolutely right. There has to be something. You've got to get something in your hand to feel confident. Though I agree with Bill that may not give you the level of confidence that you would like.
I can also just make a quick point. I'm very leery about going to a punitive measure for those people submitting on paper. Giving them a fine of $25 is not only a discouragement for them to complete the form at all. But I think the other problem certain a physician can go to the library and fill out this form, but if they don't have Internet, they probably don't have an email account either. So it may be difficult for them to get confirmation unless it is through paper form as well.
There are a lot of logistical problems here. I think the key is to make it as easy and as comfortable electronically as possible. And then get the word out through trade associations and others that this is the way to do it.
MS. NARCISI: We really do need a lot of guidance from HHS on what are the answers. How are the physicians or any providers or any covered entities going to be acknowledged. And as soon as we have that direction, we will be happy to educate our members.
One other comment I wanted to make, when we are talking about the electronic application, and that would absolutely be the simplest approach for you to gather your information, and especially on the other end. However, I have been involved in a project at the AMA developing an electronic application. And we have had a number of problems with the actual application.
But also through the testing phases, most physicians are on AOL. They are not some different other Internet service we found in our research. There are problems with the particular browser they are using on their computer when you are accessing this application. You are going to have to have some type of a customer service number when they are online trying to figure out what is going on, because it crashes their whole computer. There are things that you probably never envisioned that are going to happen with this whole thing.
DR. YASNOFF: It seems to me consistent with the testimony, that this is a tremendous educational opportunity not just to fill out the form, but to provide a comprehensive Web site that has extensive material, including descriptions and information about all the transactions, resources, downloadable documents.
I mean you could even put interactive seminars on the Web site if those were to be developed. And another thing that could be added is that we could specify optional forms that people could fill out to say if you are having trouble with this, NCVHS wants to know, and we have feedback mechanisms if are having trouble.
If you don't understand the transactions, you can fill out this form, and we will get it. So we are listening to you, and here are the ways we would like to hear from you, if you care to. And people can fill those out or not. So we can provide an easy mechanism for those people who want to say something to us, to say something. I think that would be very helpful.
The other thing is that even if we decide not to do that, or in addition to that, if we provide educational material, we can set up the Web site in such a way that we can get specific uses statistics on each piece of educational material. So for example, if we find a particular transaction gets 4 million hits on the educational material, we can pretty deduce that that's a transaction people have never heard of, or they would like to hear more about.
So I think that one of the things that we might recommend to HHS is that this be used as an educational opportunity. That resources be allocated to put together a comprehensive educational resource, which is going to be designed to provide us with feedback on usage, and provide us with opportunities to collect information optionally that people may wish to provide.
And so we can discuss that during the discussion period, but while we have the testifiers, I was wanting to get reaction to this.
MR. TENNANT: You are preaching to the choir here. I think that's exactly our vision on the WEDI task group, which was to have this Web site with all of this information available. And some would come from WEDI-SNIP as well, the work that Mark's group did on testing and things like that. I think that is absolutely the way to go.
As well, there are a lot of private Web sites, for example, ours and AMA and AHA. And maybe there could be a link to some of those resources as well. The hospital sort of steers them over there as well. Because really, this is an opportunity, and we should see it as an opportunity to educate and to move folks forward as quickly as possible.
MS. NARCISI: Yes, I agree, that's what we envisioned all along, that there would be some kind of a joint effort with all of the parties involved to do some educational things, Internet types of Web site types of education, but also we need to get it out on paper too.
DR. ZUBELDIA: On the issue of the paper, I think the act doesn't require -- it says to respond with an acknowledgement of receipt on paper submissions, of any submissions by that matter.
But I think it would be very easy to say the same as providers file a claim on paper today, and they don't get anything back until they actually get a payment, that if you file for the compliance on paper, there is no acknowledgement of receipt. If you file electronically, you do get an acknowledgement of receipt. I think that would be very easy to justify. And that's an incentive.
Another thing that could be trying to move them electronic submissions rather than paper submissions would be like you said, the ability to add to our sampling pool. When we have to take a sample, it doesn't say that we have to take a sample of electronic and paper submissions. We could say we are only going to sample electronic submissions. And that way the paper form doesn't even have to be scanable.
We don't have to get into that. And if they want their submissions to be sampled, they could file it electronically. If they want to also file it on paper, they can file it on paper. The paper copy may not be sampled. And even if they file it electronically, they may want to say in the "other" box, which is kind of private information, they may want to say this is a problem that is unique to me. You don't need to sample this, because this is my problem.
Or they may want to say this is a problem that is generic to the entire industry, and therefore, should be part of the sampling. But if they have a problem that is unique to their organization, they could indicate that in form right along the free text. Nobody has to look at that free text. It's a private problem. And of course they could have a confidentiality indicator that says this is confidential, and nobody is to look at it.
I think those are mechanisms by which we could entice them to file the claim or to file the compliance extension electronically, rather than on paper.
There are a couple of things that in the form that we have, are a little puzzling. There is a question that says indicate by checking yes or no whether an organization has completed the transaction and code sets implementation process. If you indicate yes, that means you have completed the process. You don't need to continue with the form.
I assume this is from the time where the understanding was that everybody would have to file in case your trading partners are not ready. And that probably can be taken out, because it looks like a tricky question. If you check yes, why would you fill in the rest? And I think that could go away.
Also, the NCVHS, in the letter to the secretary on June 29, one of the bullet points of things that could be done says that alternate sections could be required to be ready for implementation by the compliance date. But additional time could be given for implementation and testing with trading partners.
So I think this again emphasizes that the testing is testing with trading partners. It is not in the law, but it was the intent that the testing would be with trading partners. So I think that's that letter.
If you want to comment about this possibility of having this additional check box that says this is my particular problem, and I don't want it sampled by NCVHS. I don't want it included into any statistical samples. Please don't address it. Don't worry about it, as opposed to this is a general problem that I would like to included the sample.
DR. COHN: If you have that, why would you include it?
DR. ZUBELDIA: Well, there is a section here that says reason for filing the extension. And there are ten different reasons and then an "other." I suspect a lot of people are going to use the other. They are going to check one or more of the ten reasons, and the other. And I'm afraid that in our sampling of the forms, we are going to have to go through all this free text in the other reason. It's just logistically impossible to do. So if we ask them to indicate whether it's okay with them for us not to even sample it.
MR. SCANLON: I don't think we can guarantee that it's not going to fall in the sample. Once these plans are submitted, they are subject to FOIA and FOIA requests. They are sort of considered under individual merit in terms of what is released. But you have to assume there will be some available. You can designate confidential and trade secret and proprietary information much like you do when you apply for an FDA approval or something, and every attempt is made to redact that sort of thing.
But I think you really have to keep it simple here. There are probably going to be a million of these. And it's an automatic more or less, extension. What we do is in NCVHS in terms of the sample, and combine that with hearings, I think shouldn't drive necessarily the process, but it should be something that is consistent with it.
DR. ZUBELDIA: The forms should be such that it allows us to do the sampling.
MS. DOYLE: In reference to your first comment, I think that what might be confusing is that there is a line where it says Section 4, "Work Plan Implementation Strategy and Testing Schedule." The idea is really that question about yes or no should come under phase 1, understanding the regulations.
The idea there is that there are several phases identified here. If you have already completed that phase, you can check it as yes, and move onto the next phase. And then it's within in the phase that you are still working, is the one where you would say, no, I haven't completed it. And therefore I have this series of questions. So that was the intent. It just has to be reconstructed a little.
And I think I missed your point. One thing that I would like to raise, I think you raised the issue that the final one, the phase 4 testing, because there is a question up above about initial internal software testing, and therefore if I understood your question, was phase 4 testing therefore, probably means with trading partners.
And again, we have to go back that that is initial, that is internal, that is beginning perhaps in that phase. But this was a big discussion, at least at the AHA meeting. And it was worded very carefully to mirror the law, and that is why it says mandates the organization's compliance plan and the timeframe for testing. And again, I know this will be probably be out of favor, but we would strongly urge that that not be defined as anything other than it is testing, be it internal or external. It is important that you have a component of your plan for testing.
MR. TENNANT: A couple of things. I'm a little concerned about trying to be punitive for those providers especially that are going to submit on paper by denying them a receipt. I think if you are going to go in that direction, it should be very explicit that they should send it in such a way that they receive a receipt from the Post Office from FedEx or whatever.
DR. ZUBELDIA: They can do that.
MR. TENNANT: Absolutely, but it should be very clear that they are not going to be expecting to get something in the mail at some point.
And to your point where NCVHS should only sample those from electronic, I think you run the risk of biasing your sample. Of course I think of Dewey-Truman in 1948. You may be excluding a large segment of the group that perhaps needs the most assistance of any.
MS. GREENBERG: I actually think it's an excellent idea to say we're not going to scan these paper forms. I think what you are hearing is that the providers -- this is supposed to be administrative simplification. We say let's not make this burdensome. Do we really want departmental resources going to scanning the forms and all of that? And sending out of all of these paper acknowledgements?
There are very limited resources in this department to implement HIPAA. And the vast majority I think are going to be -- first I would really discourage people from sending both an electronic and a paper, because there is nothing to be gained by doing that. So I would be right up front about it.
And I think if you sample electronic responses, you would get enough information. But you could say if there is something you really want, and you are not going to send in an electronic response, and there is something you really want the National Committee to be aware of, send them a letter.
DR. KOLODNER: There seems to be an assumption here that the entity who is submitting the exemption cares whether NCVHS has the complete list of all the reasons why they are not doing it. They don't. If you check one box or four boxes, it doesn't matter. You get the exception. And we are treating this as if it's data that has a lot of validity and completeness and everything else.
So I think if we keep it simple, and don't read any more into the data that you need. All they want is give me that number, that confirmation that I now am exempt for another year. And I'm concerned that excluding the paper and things, there is really no incentive. They don't care whether it is analyzed or not. They want the extension for another year.
MS. GREENBERG: But we care whether we have to scan them all.
MR. ARGES: I guess I wanted to comment. And I think it goes back to Tom's analogy about the file drawer of forms that people filed because of regulation. And the question is, is the NCVHS going to do something with the paper documents after you receive them?
If not, it might be appropriate for those who don't have the ability to file electronically online, maybe do something very simply by phone where they can put in a tax ID number, and answer a couple of questions by pressing one or two on the phone, and then be done with it. And then somehow give them a number of some sort indicating that they have complied, and things are satisfied.
MS. TRUDEL: I actually have a couple of questions and issues. In looking at the sections that talk about reasons for filing the form, and whether people are going to use vendor resources, I'm wondering if the subcommittee members might want to consider whether some modest amount of additional information might be helpful in the analysis process?
And the specific questions that I have are in the section on why am I filing this form, we have already had a lot of testimony on things that we know are compliance barriers. We have been listening to this for over a year now.
And in addition to the ones that are already noted on the form, there are things like my legacy system didn't generate all the data that I need for the transactions. I'm having problems migrating from local codes. I'm having problems with a specific transaction. And I'm wondering if just a modest addition of some data might be useful for the subcommittee members?
The other question is in the area of vendor and contractor assistance, it says are you going to use one, yes or no, or I'm not sure. Would it be helpful for the subcommittee members to have some additional information like yes, no, or not sure. I'm going to use a vendor for education, or I'm going to use one for gap analysis. Or I'm going to get a HIPAA-compliant version upgrade from a current vendor that I already work with. Or I'm going to have to go out and buy new software from somebody else.
And that will give us I think an idea of what places vendors and contractors are kind of on people's critical path, and what problems might be arising. But first, let me ask the subcommittee members if that's useful information. And then let me ask the panelists whether some kind of a modest addition of that type would be bothersome?
DR. COHN: You're nodding your heads no.
MR. ARGES: I guess what I would rather see is a simple question at the end, should the NCVHS contact you with a follow-up questionnaire?
MS. TRUDEL: All I'm talking about here, George, is a couple more check boxes, yes, no, or not sure.
MS. GREENBERG: It would probably need OMB clearance.
MR. ARGES: If you put it on the form, then it becomes part of the FOIA requirement, as opposed to a more focused study, I think.
MS. TRUDEL: Why would the fact that somebody is or isn't going to use the vendor for some specific thing without saying who the vendor is, something that people would not released?
MS. NARCISI: I think you can add those questions. I think you should leave them optional, they can or cannot. They don't have to answer them. However, we did discuss this through our deliberations at both WEDI and the AMA, and I think that's fine. But then is that information public? We don't want physicians to be bombarded by marketing from vendors because they had access to this big list of all these people that need HIPAA help. That was one of our concerns. If that is going to be asked them we hope that that wouldn't be released to the public.
MS. TRUDEL: Okay, understood. Thank you.
DR. COHN: Other comments?
MR. BLAIR: As you all well know, I can't see the form. I have just been listening. I really like it from what I could hear. I also have selective hearing as well.
Karen, while I was hearing your observations, one of the things that occurred to me was if the question -- and I don't know where it is located in the form -- if the question that winds up asking questions like why are you asking for an extension, and the options include things like having difficulty migrating from local codes, and all of those other pieces.
If that is one of the first questions, early on before we ask -- it is? Good, because my thought that in addition to its utility to HHS to analyze, it is very thought provoking for the respondent that is filling that in. Oh, I've got to consider migrating from local codes. Oh, I've got to consider this and this and this.
And I would think that that becomes a very good educational tool as they are filling it out. And if they hit that before they hit some of those other thoughtful questions like is the budget in place, what are the milestones and all those other things, that we accomplish a good deal of the objective we wanted to accomplish by having those types of questions on the form.
And I guess that Rob, you probably are going to indicate that's what WEDI was thinking of when you crafted the form?
MR. TENNANT: Exactly. You're absolutely right.
MR. BLAIR: You could wind up saying even a blind guy could understand the form.
MR. TENNANT: I think the good point is that we are trying to make the form something that somebody can take, fill out, and learn at the same time. Or read before they fill it, go back to their organization and say, oh, we've got to do these things in order to be compliant.
I think our concern is if you get into more specific questions, and they are absolutely valid for the NCVHS, you run the risk of again confusing folks. So our suggestion is hyperlink the word that would go directly to a glossary or a discussion of that. What is a legacy system? What is a local code? And then they go, oh, now I know. And then that assists them as they go through the form.
MR. AUGUSTINE: Marjorie, I have a question. Is somebody going to hand enter the written surveys that come into HHS?
DR. COHN: I think you should ask CMS that question.
MR. AUGUSTINE: Oh, I'm sorry. Is someone going to hand enter those surveys?
MS. TRUDEL: That's still open for discussion.
MR. AUGUSTINE: Have they considered the use of an optical character recognition technology? We are used to in the older days, those little thin forms with the different colors on them. But they have programs now that are 99 percent effective, that you could actually take a Word document and not only scan the words in the text that they used, but also you can program it to read a survey, and put that information into a database. And if you've got a high speed scanner, you could do these in no time, and you would have higher accuracy and a lesser burden on HHS, and also on the physicians.
DR. ZUBELDIA: I know that we don't want to get any additional recommendation, additional paper work. But should that be an option? Should people have the option to send electronically some additional documentation? I'm afraid that if they don't have that option, and they also have the option to staple something to a piece of paper, they will end up filing their own paper, when they could have filed it electronically.
Maybe we could have very strong discouraging words at the bottom of the form that says if you want to attach something electronically, we are not going to read it, just for your own peace of mind; something like that. Would that be an option?
MR. SCANLON: Remember, the main purpose here compliance extension. It's not really a research project. And you have to give the covered entities the greatest leeway in terms of how they file it, much like you do in terms of public comments. And we should never confuse research projects with administrative -- though we will certainly use them.
DR. ZUBELDIA: I'm trying to save where they are filing electronically.
MR. SCANLON: You can't force anybody.
MS. GILBERTSON: Lynne Gilbertson, NCPDP. To Kepa's question, don't they have to be able to at least attach a document that would have all their tax IDs on it?
DR. ZUBELDIA: There is room in the form to put multiple tax IDs and multiple names.
MS. GILBERTSON: But what if it's 5,000 doctors?
DR. ZUBELDIA: There could still be room in the form to file 5,000 doctors' IDs if they want to do that.
DR. YASNOFF: It seems to me to facilitate entities that have multiple providers, it would be good to define a format for an attachment, a spreadsheet or whatever you wanted as an attachment, that would have those tax IDs. That way, through a common format, you could submit 5,000 IDs. It certainly doesn't seem consistent with administrative simplification to have 5,000 IDs typed in on a form when they could be generated automatically into some file format and attached to the form when it is submitted.
DR. COHN: Good suggestion, good point.
MR. AUGUSTINE: And ASCII text that is easily exportable.
DR. YASNOFF: But we need to define the format.
DR. COHN: Well, CMS needs to define the format.
MS. TRUDEL: I think it's important to remember that there are more than two things that we are trying to do here. One is that we are trying to grant people extensions. Two is that we have some, however minimal, assessment and research requirement placed on the committee.
But the third thing, and the thing that was the most important to Congress, and the reason that this is passed instead of the Senate is that the submission of this form, and it's not just an extension form or request, it is called a compliance plan in the statute, is that the Congress wanted people to think about this.
They didn't want people to sit down and dash off a form, and send it into us, and not really think through the steps that they have to go through, and what it means to them. And it seems to me that at least if we don't ask for some basic information that makes sure that people even understand which transactions they are going to have to implement, it's going to be a little bit difficult to go back to Congress and say, well, yes, we did what you wanted us to do.
Again, I'm wondering what the panel members think about the issue of this compliance extension plan being something that requires people to think through the steps in a thoughtful way, and also is just kind of throwing something out of the clear blue. What would you think about setting a future date on when people can send these things in? Say in other words, we are not going to accept any plans or extension requests until June. I'm just opening that up for thought.
MS. GREENBERG: Can we discuss that after the break?
DR. COHN: Yes. There is actually time for a break. Let's take a 15 minute break.
[Brief recess.]
DR. COHN: I think we had started the break immediately after Karen Trudel had a made a comment or two about maybe there should be a little more in the form. Perhaps you would like to rephrase your comments, and then allow us to have a little more conversation about it.
MS. TRUDEL: I think my point was not necessarily that there needed to be very much more in the form. My concern was that perhaps we might be losing sight of, or that the people who are completing the form might never catch sight of Congress' main purpose in passing this particular version of the bill, which has this requirement in it.
And that is that they want to make people think about what they have to do to become compliant. And then plan that, and that will give them something to work toward. And I think what they particularly, and Rep. Hobson did not want was to come to October 2003, and still have people being unaware and unable to comply, because of the lack of that kind of advanced planning.
And I guess I wanted to ask the panelists what kind of sense they have of the degree to which that is likely to happen. Are there things that we can do to kind of mitigate that, and to make sure that people do use this as a planning opportunity. Is there a possibility of a need to discuss whether we should say that we will not accept compliance extension plans before a certain date, so that people have the opportunity to do that kind of thinking and planning?
And lastly, I know that we don't want to gather voluminous information about every single transaction, but not a threshold question be do you even know which transactions you are going to have to implement? Like check some yes, no, or I'm not sure. I think that gives people plenty of food for thought. And I think it gives secondarily, the subcommittee some more information to work with.
MR. ARGES: I think you bring up some excellent points in terms of the need to utilize this process as a way of making the health care community aware of the steps they need to take to move towards being compliant by the implementation dates, either the 2002 or the 2003 dates.
I know we did in some sense as a task group, revise the form, and we tried to add the various phases as a way of kind of emphasizing again the kind of steps people need to take. I'm not sure, however, in terms of refusing to take applications earlier, would provide any benefit of raising the level of awareness.
I think it's incumbent on all the organizations that are involved in the health care field to basically make certain that their constituents and their members are aware of these impeding changes. I know our organization has been involved in developing some information. We developed a CEO binder on the transaction standards and code set last year. And it included some of the checklists that you just mentioned.
I know we are going to be stepping kind of a phase 2 approach afterwards. But I'm not sure what we can do in terms of the additional question or holding off on the implementation of filing this, whether that would help. But I do agree, it should be a lead in to kind of remind people they need to get moving on these transaction standards.
MR. TENNANT: If I could just piggy-back on what George said, I agree with that. I don't think we can hold off on folks submitting this, because we really want them to get started as quickly as possible. And it is going to take a lot of time, and we don't want them to say, okay, I can hold off until June or summer or fall before I start this.
But I think Karen's point is very salient. And that is are we following what the intent of the law was? And I know I had conversations with the Hobson staffer that wrote most of this. And his point was exactly what Karen is saying, get the provider community especially, jump started. Get them going on compliance.
And I think the form does that. As George said, we have identified different phases. And really the key is to not have the form be the sole instrument of education. If we can, again, provide these ancillary documents, and really provide some assistance to the provider, I think that will make it a success.
MS. DOYLE: I also agree with Rob on this point in that if people know that a form is not due until June, are they going to wait until May 15 to even look at the form to file it? And I think this particular document is very valuable in helping people understand all the work that is needed to be done.
So I think we would say almost the earlier the better, people look at this document, that they understand. And I think there is value in people filing early, because it gives also their trading partners an idea of where they are, that they have filed the extension, or whatever the case may be, assuming they would obviously be communicating. But I think the more valuable point that we think the earlier the better.
MR. RODE: Dan Rode. I've got my cap on today for CHIP, the Coalition of Health Information Policy. I wanted to hit something else Karen mentioned. I think a checklist of yes, no, or I'm not sure on the transactions would be very helpful, because while the plans have to follow most of the transactions, many of the providers don't. And I think it at least calls the question to mind on what are they going to be filing for, and secondly, at least make them think about what it is. Because if they are going to start checking off premium payments and the 834, I'm going to start questioning whether they know what they are talking about.
And since you have all brought up that it still needs a lot more education, I think it would both cause a chance to identify -- go back and look. What transactions can you really do, and really have to do. And it would also give the department and committee a sense of how much are we going to see on this? Because a personal opinion, certainly the 837 claim may be very predominant among providers, but a number of the other transactions may not. And they may be very situational.
The other thing that you may want to add to that is whether they are going to use a clearinghouse instead of other types of vendors, because it will give another sense of how many people are going to remain in the same situation they are today, especially on the physician side, where many physicians use clearinghouses, and may or may not have a real reason to move to the other. So I think those two questions would be insightful for education, but also would give the committee a chance to see an easy of what ways people are considering to implement.
DR. COHN: Comments from panelists? Does the fact that there are no comments mean that there is general agreement with what was just stated?
MS. NARCISI: Yes, I agree that the opportunity to educate all the covered entities will be a tremendous opportunity. And that either it should be done like linking to certain Web pages and what not. But I don't think we should delay getting the form out. I mean that's just another delay in the whole HIPAA thing.
DR. COHN: I think I'm hearing general views from the panelists that there shouldn't necessarily be a delay in the form. But since Karen had asked a two part question, one, should we delay the form and filling it out. But then also is a good question asking this question about the transactions, and which ones are they going to be working on to be in compliance is also a reasonable question to ask? I think I'm hearing sort of general agreement to those two pieces?
MS. DOYLE: May I just ask a clarification? Was her question, as I read it, you know what transactions you need to implement, and that's yes, no, or I don't know? I assume at that point you would also have to -- assuming the person doesn't know, isn't that where the educational documents would be helpful? That you can then go if there is any question, rather than asking specific questions about each transaction.
DR. COHN: I think rather than just saying do you know which transactions you need to implement, I think you probably want to get down to the actual which transactions. And then provide education from there, especially if you have the opportunity for additional education, which I think would my by sense.
Once again, I brought up an earlier issue, which was that all the transactions are not alike. This is not the same as security. It's not the same as privacy. It applies to the entire organization. Part of the compliance plan is to know which ones you are going to do, and that's a pretty fundamental first step before anything else happens.
MS. TRUDEL: I think my concern in suggesting that as a possible question is that if the covered entity does not know the answer to that question, how do we assess anything else that they tell us? And if we don't ask the question, how sure can we be that the covered entity knows the answer?
MR. WILDER: I do think the form does attempt to educate people about the steps they need to go through to get ready to implement. And that was set out in Section 4, where we have got the various phases, and under each phase, the steps that you need to do. I think throwing in a question just asking in general if they are familiar with what transactions, with a link then to the various transactions that explains them might be helpful.
Again, if you are going to start throwing in all the transaction, you are making the form more complicated. I question are you then going to be collecting that information at NCVHS to start analyzing that? If you have a link just from the general question that causes the people to go to that one area to then start thinking about what transactions they need to do and looking at.
MS. GILBERTSON: Two thoughts. One is when you are referring to the provider community, do they know what an 837 is? Do they know what a Batch 1.1 is? So we have to be concerned that they can either answer the questions.
The other is the consideration of will those transactions be listed as they exist in the final rules for October 16, 2002?
MS. TRUDEL: I think we are talking about something like claims, not version 4010 or batch versus online.
MR. ARGES: I guess I wanted to agree with Tom over here to the extent that Section 4 does kind of lay out the phases. And I think linking some of the questions to a more detailed explanation of what it means. For instance, under phase 1, understanding the regulations, the very first question, understand what the regulations require of your organization.
There you might have a hyperlink that says it requires you to basically implement the following types of transaction standards. Do you understand what those mean, and you're comfortable and you understand what you need to do to kind of move forward with those? So selectively picking that, or adding more narrative to it as a link I think might be helpful under those types of areas to kind of further educate people about what some of those questions mean might be helpful.
MS. NARCISI: Well, I wonder if listing would be that valuable. And the reason I'm thinking about that is that there may be physicians that are going to use a billing service. They don't care what transactions are mandatory. They don't know what an 837 is; they will never know what an 837 is.
So I'm wondering if how you think you're going to gather the information, if it will be that valuable, unless it's like an optional section that you allow them to fill out. But they may file an extension form. They may continue to use the service, even though they are not sending them directly out of their office electronically through their vendor, or just sending the paper forms to a service. So they may not give you good answers.
DR. COHN: Other comments? Karen, does this provide you any direction?
MS. TRUDEL: Yes, I think so.
DR. COHN: Other questions, comments, issues?
Karen, I guess I will ask you a question, since I think in another role you are actually trying to put all this together and make it actually happen. There has obviously been a strong, major discussion here about not only having a forum, but having an educational resource all on the Web, all enabling sort of this education, compliance delay and all that. Is there funding and support within CMS and HHS to make all of this happen? And if no, what parts are at risk?
MS. TRUDEL: I think that the likelihood that we will do a broad scale provider, covered entity outreach program specific to the delay in the compliance form is at risk. I think the question of whether we use resources to carry out very resource intensive processes like hand keying paper documents, the consideration there is what return are we getting on that investment. As Marjorie said, the resources are very limited.
What we are focusing on is specifying in The Federal Register what the form will look like. What the model compliance extension plan will look like, or whatever we decide to call it, and trying to find at least a straightforward way of people being able to provide this to us electronically.
So those are my current major focuses for the time being. To the extent that we can take advantage of other educational processes that are underway, or any other Web sites or linkages that we can use, we will do that. And to the extent that my bank balance goes up, we will expand the amount of educational material that we can available in that same place. So that's the answer I can give you right now.
DR. COHN: I think that's a very good answer. Thank you.
DR. FITZMAURICE: Karen, I want to follow-up on that. In the law that was just passed extending or allowing people to apply for extensions, it also talked about having $40 million or $44 million authorized to HCFA to implement the different HCFA processes. I assume that includes identifiers for providers and other things. Would that money be welcome? Is that money essential?
MS. TRUDEL: Funding is always welcome. I would specify that if you look carefully at that language, it is authorized, but not appropriated. The funds are not appropriated. The appropriators would have to look at how this fits into other caps and pre-existing allocations of funds. And to my knowledge, that hasn't taken place yet. So if you look at the president's budget as a finite thing, then this adds an additional burden to it that they will have to cope with.
Certainly, as I said, the funding would be welcome. We know exactly what we would do with it. And will things come to a crashing halt if we don't get it? No, but it again, is the difference between us doing a very broad scale outreach program, and one that is more scaled down.
MR. BLAIR: One of the things that might be helpful, I think that a lot of the representatives who have worked on this model form at WEDI have been representatives of health care institutions that could afford have to them take their time to participate in this work effort. That seems to be the characteristics of a lot of our standard efforts.
It's very difficult for a solo practitioner or somebody from a small group practice to carve out the time to get their influence. So my question is, because I don't want to wind up having multiple instruction sheets for different health care institutions, but there may be one that may help, one division that may help, where the instructions for a solo or small group practice. Those instructions may be really very, very different in nature from those who are filling it in for a health care institution.
If you all feel like that would be useful to have two different sets of instructions, one for folks filling it out for institutions, one filling it in for small group practices, if you think that that is worthwhile, that's one question. And then the other one is, if so, then what is the dividing line? Is it five physicians or less, or ten, or what are your thoughts on this idea?
MS. TRUDEL: I would like to actually tack onto that another possible alternative there. I know I think George or somebody talked about the easy version of this, and the fact that it's easy already like the tax form. But I think Jeff's point is really we may need to have the same form, but different instructions where it is not a question of using one set or another, and say, okay, small provider you use these, big providers, you use these.
It might be that for instance we could work with the AMA, and because they know their constituency better, perhaps they could develop an auxiliary set of instructions that would be more explanatory and more specific to that particular constituency. And I would open it up that the AHA might want to do the same thing, and we would be happy to work with them on that.
What do you think, Jean?
MS. NARCISI: Well, I think that might be very valuable, because I'm thinking too about the educational opportunities, and you may want to specify certain things for a physician's office that wouldn't be important to a large hospital or a clearinghouse or to a payer. So I think you can get real specific in your educational pieces.
I think you could make the companion document probably much smaller, otherwise, you may end up with a big implementation guide type of format to follow the form, which you don't want to do. So I think that would be very valuable. I think that's a good suggestion.
MR. ARGES: Actually, we had talked about this at the AHA, and we plan to do that on our Web site, to basically provide guidance to our constituents. We would be happy to work with CMS to make certain too that as they maybe get questions earlier on, that we can craft them and make certain that the answers are there to help people through completing the form.
I do think one form is sufficient, but I just think tailoring or anticipating the type of questions that might apply to a specific category of covered entities would be helpful.
MR. TENNANT: If I can put on my MGMA hat, and Jeff, a lot of our members are those small group practices. And we will be doing something similar to what George talked about, putting out information specifically geared toward these small practices. I think that would be extremely valuable.
Because you've got to think of it like the 1040-EZ, which is a one page tax form, but it has a 50 page instruction booklet that goes along with it. But it is aimed for the average consumer, plus somebody with advanced degrees. I think this hopefully not fictitious Web site that CMS is going to produce, you can have different sections, for the small office, click here, and get specific information. The instructions should be again, as Jean said, simple for all. I don't think we can have 5,000 different versions of the instructions. The form is not that difficult to fill out.
But one concern which sort of goes along with this, there are going to be many physician offices -- I hate to say it -- that are going to be confused about what HIPAA is, let alone why they need to apply for an extension. So on top of all of this, there has got to be HIPAA 101, three paragraphs explaining what the heck this all is about.
DR. COHN: I think that's HIPAA 1, not 101.
DR. ZUBELDIA: Will the WEDI-SNIP educational materials help them? Will they be included or linked in the Web site? There are a number of white papers WEDI has released.
MR. BLAIR: Do you think that would be more towards the institutions?
MR. TENNANT: We have actually a series of very short one pager overviews of all of the regulations, including sort of a general on HIPAA. And that might be something that could be included as well.
MS. DOYLE: I was going to say that certainly if they have a lot of educational information for some clients. But I do see that maybe there is value in that the payer community, maybe with the associations would work directly with you in that instructional document for payers. That would probably be the most detailed, and the largest probably, because we have do all the transactions. But I think it makes a lot of sense. Payers would know what the issues are from their vantage points, and they could be helped with that document.
DR. COHN: As I'm thinking here, and reflecting back on one of the first questions you asked about whether or not it needed a long list of what transactions a provider has to do. It may be that if we have stylized educational materials for various classes, that might nest that issue. Whereas, part of the educational materials for single providers or others, it's sort of explained to them maybe what their requirements would likely be. So that might be a way to handle that in a reasonable fashion.
I see nods from the panelists that this might be a good solution for that issue.
Other comments or questions?
MS. NARCISI: I have a question. I guess we have talked about this in the WEDI discussions, and also at the AMA that we wonder how will the form and the instructions and what not be communicated? Is it something that would be in The Federal Register? How is it going to be communicated to all the covered entities that they need to do it?
MS. TRUDEL: At this point we believe it will be a Federal Register notice. And the notice would include not a paper facsimile of the form; more a list of the data elements that will be required, and the values. Because keep in mind, The Federal Register has a very particular publication structure and format. So what else we would do would be to provide people with information as to where they could get a facsimile document and instructions.
DR. COHN: Other questions and comments?
I guess, Karen, I should ask or just clarify, I don't think that the intent of the session had been to actually compose a letter to CMS about these various issues. But as I say that, would that be helpful, or has this sort of input been generally sufficient for CMS needs, and development of the model compliance form?
MS. TRUDEL: I guess I would like to clarify. There were some potential questions raised about possibly adding information. And I think what I heard was that in terms of adding a list of the transactions and say check off the ones that you think you are going to need to implement, we won't go there.
In terms of adding to the compliance barriers, some of the common barriers that the subcommittee is already aware of, we will do that. And in terms of the vendor or contractor assistance, saying what are you considering using a contractor or vendor for, we need to, before we do that, visit the issue of proprietary information so that we don't wind up supplying vendors with mailing lists of potential clients. But I think I also heard that if we could get over that hurdle, it would be useful information.
If that's what the subcommittee wants me to take away, then I don't think I need a letter.
DR. ZUBELDIA: I don't know if we have reached any consensus on adding the ability to send an attachment along with the form, either to list additional tax IDs, or additional names of entities, or some other attachment they may want to send in with the form.
MS. TRUDEL: If I can take away your recommendations about whether an entity can submit one single form covering other entities for which it has a legal obligation, if the answer to that is yes, then I'll take that away and work the requirements out myself.
DR. YASNOFF: There were one or two things that I think we agreed on. One, that filling out any forms that are on the Internet with this information should be secure. So they should be SSO-enabled forms, so that people don't have to worry about their information being intercepted en route.
And second, that any electronic submission should result in an immediate acknowledgement, perhaps by email, but even better essentially a confirmation number displayed immediately that people can print and keep.
DR. COHN: I think this is what we all sort of agreed to. Is there anything else that we are missing?
MS. GILBERTSON: I was just curious if you have an idea what you might do with the information once it is collected? There was some comment by the panel about if this information would be posted on the site. I know there have been questions about do I go to a site to see who has filed compliance. Is there thought what happens, whether I need to check if my partners have filed, or any of that information available?
MS. TRUDEL: We're not anticipating that we are going to make a registry available. What we do not want to do is to interpose this process in the middle of the ongoing communications that providers and plans should be having with their trading partners. We would prefer that providers and plans go to their trading partners, and continue to communicate on an ongoing basis, and as things change, to modify how their testing is going to go. I mean this is a handshake between two parties, and the status will change over time. So that's really how we want that part of the process to go.
DR. ZUBELDIA: On the paper version of the claim, did we reach a decision as to whether it's going to be acknowledged with some of --
MR. BLAIR: Do you mean the paper version of the form?
DR. ZUBELDIA: Of the form, sorry. There is going to be an acknowledgement of receipt, or it would be up to the sender to get an acknowledgement of receipt from the Post Office rather than HHS acknowledging the receipt?
DR. COHN: Does the subcommittee have an opinion that they wish to share with CMS on this, that is held by all the members of the subcommittee?
MR. BLAIR: My inclination is to use the acknowledge as a compelling incentive. If somebody enters it electronically, and just indicates that the respondent is still about to put it into the Post Office and get a registered mail or whatever, certified mail, if they wish to. But that HHS would not make a separate effort to give them an acknowledge if they send it in by mail.
DR. ZUBELDIA: That would be my preference too.
MR. AUGUSTINE: That would be my preference.
DR. COHN: Absent any other information, I think the Post Office functions very well in that, as do other carriers in terms of assuring receipt of mail.
Other guidance? I want to thank Karen for her hard work in all of this. I do think that there is one issue that will probably go over to our next topic, which is the administrative simplification report to Congress that has to do with this issue of the general educational effort. There is clearly, I think, an issue at risk, and we need to bring it to the secretary's attention probably in a cover letter that goes with the administrative simplification report.
We are going to transition topics, so I want to thank the panel for really great work. And I want to thank you all for working together in terms of making this all happen.
Jim, I had a sense that you have to leave?
MR. SCANLON: By about 12 or so. I'm chairing another meeting at HHS.
DR. COHN: In that case, I think we will move into the discussion of the report on administrative simplification.
MR. SCANLON: I think everyone has, Simon, a copy. This is a very first draft for the 2001 annual report to the Congress. Everyone has a copy in their folders, and we sent it out to everyone via email. And we are sending to the privacy subcommittee as well, because this is now integrating the privacy standards and the suite of administrative standards as well.
As you all remember, the NCVHS has among its many jobs assigned by Congress, has one of preparing an annual report to Congress on the implementation of HIPAA administrative simplification. And this year's will be I guess the fifth annual report to Congress since the law was passed in 1996. It will cover the calendar year January 2001 through December 2001, although there will probably be a bit of a spillover, because the compliance extension act was towards the end of the year.
And the format that you are looking at in terms of a draft is that there would be an executive summary of about seven pages, and then a fuller report that has a lot of the detail that may not be in the executive summary, and some of the background. So someone relatively unfamiliar with HIPAA could go back and see how things were set up.
I guess, Simon, what I would want to do is there are two things. One is the subcommittee content and priorities and so on. But the second would be in planning for the full committee meeting in February, that we will have a draft to share with the full committee, but probably ask the full committee for an approval with the flexibility to do some editing in adopting the full report, so that we wouldn't have to wait until the next full committee meeting in January.
So I think what we would be doing, assuming there is agreement around the table, we would have a draft for the full committee to look at, take comments from the full committee, and then ask them to adopt a process whereby we can incorporate further changes and so on, without having to go back to the full committee for approval, which is kind of what we have done previously.
DR. COHN: This is had been the usual process, as we all know. And I think certainly at the time we have, we should not be wordsmithing the draft. And it does need considerable wordsmithing, but it is a draft. I think really what we need to do is to have subcommittee members review it, once again, not for wordsmithing, to make sure that the information is factually correct.
MR. SCANLON: And that the major issues that we wanted to raise are there.
MS. GREENBERG: This is February 7. We will be sending the agenda books out to the full committee on the 18th, the week before the meeting. We'll FedEx them. The meeting is the 26-27. So people are going to have to turn around their comments very quickly to Jim, because I would assume you would at least want to get some revisions in. You want another version than this one to go to the full committee? So it's going to have to a really quick turn around is my point.
DR. COHN: I guess what I will tell you has been my traditional role as subcommittee chair is I will obviously work with Jim for some actual wordsmithing issue. We'll move whole pages and other things that I noticed when I was looking through. Really, it's more an issue for other subcommittee members to take a look and see if we are setting the right tone and all of this stuff.
And just for example, this looks a lot like last year's document.
MS. GREENBERG: And the one before it.
DR. COHN: Well, I think we have begun to highlight issues about the need to get the rules out. And I think we have an additional issue this year that was really brought out by the last testimony that the delay in the rules, such as for example, the modified NPRMs to final rules make it inevitable that all parties will have to request a compliance delay, which undermines the potential success of the final implementation.
MR. SCANLON: There is a whole tone, if there were headlines, what would they be, what would the tone be? And I think for this past year in one case there was finalization of the privacy rule, which I think the committee would acknowledge is a milestone, and the issuance of guidelines.
But on the administrative simplification side purely, it was the year where the headline really was -- well, there were some notable accomplishments in terms of the BSML process, the fast track changes. That all worked really well. And then the delay responding to industry concerns, Congress passed a delay.
Unfortunately, we didn't issue any proposed or new rules, proposed or final relating to those standards from HHS. Work went on, but you kind of have the situation where there is not much more known about implementation of this suite of standards than previously.
So again, I think the tone is that well, the delay seems to be responsive to what industry wanted, but unless the final requirements are known, it's more or less an empty delay, an empty year. And there is some wording for the full committee and the subcommittee to kind of emphasize that as well. That's the basic tone.
DR. COHN: Yes, I think those are the big points. And obviously, I can't speak for the privacy subcommittee, and certainly won't.
MR. SCANLON: We emailed it to Mark, and will get it to the others as well.
MR. BLAIR: One thing that we may want to consider including is that despite all of the frustration that HHS has had, and providers and payers and clearinghouses have had with the delays, you can include the whole industry being frustrated, despite all of that frustration, and in some cases it's more than frustration. It's lack of being able to reap the economic returns, and having schedules and budgets readjusted.
It's a great deal of impact on the industry. There are many surveys that restate the commitment of the industry to not only the administrative simplification provisions, but continue to ask for acceleration in getting the final rules out. And maybe it might be useful to quote the industry surveys to indicate the strong industry support for this, despite the inconveniences of the delays.
DR. FITZMAURICE: I think even in today's testimony -- you can pick out from today's testimony that they want the standards out as quickly as possible, expedited, accelerated.
MR. SCANLON: Getting the standards out I think is one voice. But obviously, there are many voices in the industry in terms of work needed.
DR. COHN: I'm also remembering our June 29th letter where we actually did notice that in all that testimony, there was really not anyone who was against administrative simplification, and also a value for. Maybe once again, pulling some of that out. I think Jeff is right, that's one of the key messages that there needs to be some more action.
MR. SCANLON: I think we have seen from the surveys that this probably is the number one IT priority in health care.
MS. GREENBERG: You mentioned that.
MR. SCANLON: The burden, I think the way we phrased is, the burden falls equally on the industry and HHS for different reasons.
MS. GREENBERG: I want to thank Jim and his associates for taking the lead on this annual report. I thought it looks pretty good and comprehensive, and I will send my edits, and some updated information the public health data standards, and a few other places.
The one thing I was thinking was we should add something in here about the NHII report, because I think it's kind of HIPAA plus, plus, plus. Standards are a basic part of that report, but it isn't mentioned here. And it was a major milestone for the committee, and I think it is related, and it's a good opportunity to kind of alert the Congress to that report.
DR. COHN: That's a very good point. We should ask the chair of that work group to provide some data for us.
MS. GREENBERG: I think you just take something from the report probably.
DR. COHN: I agree with what you are saying, and I think that does need to be included. I was also going to come to we probably need to make some comment about the $44 million appropriate, because it does go to Congress, the authorization. And the fact that it's an authorization and not an appropriation.
DR. FITZMAURICE: That it would be welcomed, and is needed.
DR. COHN: Yes, exactly. And I think that's something that probably is timely. Congress would appreciate seeing something reminding them about the need to appropriate, as well as authorize.
Other issues, comments? It's good airplane reading. I think it's a cover letter issue.
MR. SCANLON: On page 7, there are implementation issues which sort of changes from year to year. And this year they include the need to have the remaining HIPAA standards available, particularly the fast track changes, the modifications to the privacy rules. We need to have those out as well. HHS resources, funding to the FOIA identifiers, which I think is fairly highly dependent on funding. There are some other issues that we're carrying over, and we that we would ask everybody to look at.
But we may even want to think of a shorter report, where we basically use the executive summary as the place really for the bulk of the report, and the main point the committee wants to make. Pull a few of those out of the cover letter. The rest of it is more of a documentation, where are we on this, where are we on that. I guess it's a good reference, but we may just want to shorten the report to eight pages. We'll look at it.
DR. COHN: Actually, as I looked at it, the executive summary is not an executive summary. It's the report, and then there is an appendix, and we probably need an executive summary.
MS. GREENBERG: This is the way it's been the last several years. So we could change it.
DR. COHN: It's just that the executive summary keeps getting longer and longer.
MR. SCANLON: Well, I think we can assume more of the background -- I hope we can assume that more of that is understood now, and we can just focus on the issues.
MR. BLAIR: Jim, what are we saying about PMRI?
MR. SCANLON: That the committee did submit the report. There is a whole section on it.
DR. COHN: Actually, I think that needs to be extensively revised, since that was all year 2000 what you are referencing, and that probably needs to be in the appendix. I think what we would say about PMRI is that the committee held hearings to come to final recommendations on what would be our recommendations for PMRI. Jeff, does that sound okay to you?
MR. BLAIR: Yes.
MR. SCANLON: There are two very short paragraphs in there now that you should take a look at that talk about the 2001. But you probably want to expand that on page 4.
MR. BLAIR: One of the things that I was thinking of, and I really wasn't sure how to handle this, or whether it needs to be part of what we mention in there. I guess it kind of cuts both ways is that the NCVHS considered a strategy which does not require a final rule or mandate for PMRI standards, but instead looks for HHS industry guidance and incentives.
MR. SCANLON: You haven't actually done that yet.
MR. BLAIR: Oh, premature, okay.
DR. COHN: And the thing is we'll have a separate letter hopefully out in advance of this that says all of that. You could say something like the NCVHS is considering something like that.
MR. SCANLON: It clearly states that the first set of actual recommendations on standards for PMRI are anticipated from the NCVHS in early 2002.
DR. COHN: Other comments for the annual report?
MS. GREENBERG: Can we agree that a week to get your comments to Jim?
DR. COHN: And Jeff, we look forward to your and Mike's comments about PMRI.
MR. SCANLON: We pretty much are using much of what we said last year. I wish we had more to report. As you can see, the general tone is there were some good accomplishments, and a lot of hard work. We have the delay, but we're still sort of waiting for the final wave of national requirements.
MR. BLAIR: Could we refer to it as a compliance extension rather than a delay?
MR. SCANLON: Yes, in fact I only use the word extension in here.
DR. COHN: Other comments about the annual report?
The next topic is our issues for 2002. I think as you all know, I try to keep a list of what I consider to be the outstanding issues, update them, and bring them back for reflection from time to time. What is new from the previous list is obviously the fact that we have included the Administrative Simplification Compliance Act requirements, item six.
First of all, it was development of model compliance forms, which you have already commented on, and is really pretty much a done interaction. However, for the remainder of the year there is going to be the issue about the analysis of a sample of the compliance plans, and then publishing reports on effective solutions to compliance problems identified.
Now what I would comment on is that the publishing reports on effective solutions doesn't necessarily need to wait for us to get responses to the model compliance form. And I think that that is actually probably I wouldn't say urgent to do, but a mediumly urgent to do, where we should start having conversations probably in April if we can find a couple of hours to talk to WEDI and other organizations that may have best practices that may be publishable, and of general interest that we could sort of begin to have conversations around all of that.
Is that a reasonable next step around the Administrative Simplification Compliance Act and our responsibilities? Do people have other thoughts about what they would like to do with that?
MS. GREENBERG: Two things. One is I assume publish can mean on the Web site.
DR. COHN: That's part of the discussion, I think.
MS. GREENBERG: And it maybe could even be pointing to some other Web sites and documents. But if there is anything that you -- a group that currently working on documents, or want to develop your own documents, we do have some limited contractual funds.
But agreeing with what you said, knowing that sooner rather than later, that you feel there is an area that maybe isn't covered by the current white papers. There is some possibility to do that. I think other than a letter. I think subcommittee itself is probably in a position to be drafting documents.
DR. COHN: I think our first act is to survey and find out what's already out there. And identify what is publishable. At least that's sort of my view, and I think you commented about all the ways that publication can occur. So I thought the very first act was let's not develop things that have already developed very well.
MS. GREENBERG: I know we have had some discussions. I don't know if it's been around this table, or whether it's around the Health Data Standards Committee table about the extent to which the department or others could help WEDI, which primarily functions as a volunteer group. That's one possibility if there were particular topics that we wanted to underwrite.
DR. COHN: I think that it's good to know that we at least the tools at our disposal to help move forward best practices and publication of them.
Other comments about this particular issue? As I said, we'll try to find a couple of hours in April. I already sense that with all the code set to dos from yesterday, that that will be most of what the April meeting is.
Now I should also warn you that we will be serving all of -- it's time to figure out the hearings for the last half of the year. Obviously, topics are to be determined, but I think unless I hear otherwise, what I'm probably looking for is another three sets of hearings, each two days long for the period of July through December. And so we'll be checking with all of you about your availability.
Dr. Yasnoff, it looks like you have a question.
DR. YASNOFF: Would it be easier to do a preliminary on that now?
MS. GREENBERG: No, I think it's best to do it by email.
DR. COHN: What we'll do is give people ranges of dates for three different hearings, and actually ask Jackie or Marietta to sort of collate them for us.
DR. YASNOFF: The sooner the better.
DR. COHN: Yes, I agree. That's why I'm bringing it up now. The last half of the year is beginning to fill up already.
Now beyond that, I actually did want to bring up -- it sort of falls in line with the other issues here, but I think you have all heard me express concern about the overall process issues related to HIPAA. And I'm not referring to the industry process issues at this point. I'm referring more to the processes of getting the regulations out, getting improvements, updates to the regulations out, and all of this.
And I think we are getting to a point where I think I am proposing not for April, but at some point, either May or summer or early fall we have a hearing that is really focused on looking at the overall federal process, and how it has worked, and what's working, and what is not to see if there are some recommendations we need to make either to the secretary or to Congress about things that would make things work a little smoother.
I think we are sort of beyond a point where we have a history of sort of I won't say complaining, but alerting the secretary that there are issues. And I think the problems are perhaps a little more structural than they are just issues that are served by sending regular notices to the secretary, where we get responses, and then the deadlines are again missed.
So I think that probably people in the industry have concerns about this one. I think you are hearing my concern about these. And so I want to get input from the subcommittee of whether that would be something that would be useful, that we spend a day inviting testimony and advice and guidance on.
MR. BLAIR: I think so. Let me mull over my thoughts. There are a number of thoughts in terms of how do we do this in way where at least something that is constructive and actionable.
DR. COHN: Well, I think that's the point. This is not a political discussion. This is not an occasion for people to complain. It is really much more of an occasion to look at what we have learned over the process for the last while, knowing that we are now into this five or six years, and see if there are suggestions that we have to Congress and others to help improve the process, make things work better.
MS. GREENBERG: Well, if you were to have a hearing on this topic, and certainly we all would agree that the process could work better, we would like it to work better, but there are aspects of due process and commenting and responding and all that, which are time consuming. And then there are change overs in administration. There are a lot things of our political process that slows us down, which I assume is why don't want regulations on PMRI, among other reasons.
But whom would you call? You are going to hear pretty uniformly from the industry I think they really appreciated the openness and all of that, and they really don't appreciate the delays. So were thinking of actually calling people, asking people from within the department to come and talk about why things didn't move along as fast as they should?
MR. BLAIR: Maybe -- my thoughts on that, Marjorie, is that maybe if you and Michael and Jim and Karen did a little bit of private thinking about who within Health and Human Services might be able to give us some suggestions or guidance for process changes that could help ameliorate these situations in the future.
MS. GREENBERG: I'm wondering, almost a roundtable discussion with various different people? I'm not really sure we need to hear from the industry on this. I think they have spoken.
MR. BLAIR: The industry has already been voicing their thoughts.
DR. COHN: I think the only industry view would be -- I think the industry has experience with federal regulations and implementation of federal regulations that have gone smoothly, and have been successfully implemented, and others that haven't. And they may have some thoughts or suggestions, with perhaps a slightly longer view than some of those in the government to provide some input.
And it would be along those lines. It would not be -- once again, you're right, I think we sort of know many of the issues. The question is what are the solutions? What can we propose either to the secretary or the Congress for changes that would make things work better?
I don't think that we need today to flesh out completely how we do this. It's really more I wanted to bring the issue up, see if people feel it is a timely discussion, and something that ought to be brought forward in this year's agenda.
Marjorie, I think you brought up some very good practical issues of how we do it. And we obviously need to do it in a way where it is not perceived as political, and that is somewhat time dependent, because we are in an election year. But beyond that, I think it's still an issue that needs to heard.
MS. GREENBERG: I just have one other question in regard to this. Is everybody comfortable just waiting until early April to discuss how the committee is going to discharge its responsibility to analyze the sample compliance plans?
DR. COHN: I hadn't even planned to discuss it then, actually. I thought the bigger priority was publication of best practices. But I would look to all of you about what you see as the priority on that particular issue.
MS. GREENBERG: I would say the industry seems to have taken a fair amount of freedom in interpreting what is required in the extension form. But nonetheless, it is something that is required, and it has to in good faith, do it. What kind of sample or how many, or whatever, and how we are going to get the information.
But it's going to require some part of the department, I'm assuming CMS, to do some prior analysis, hopefully based on electronic submissions. And since the form is almost no free text -- you can't do it overnight. It takes a little bit of time. And then some process for the committee. I think we need to be thinking about this certainly by April.
DR. COHN: Let me comment, and then Jeff will comment. I guess assuming that they aren't due until October, and they are likely not even to be developed and on the Web before April, I wasn't sure that we needed to come up with a methodology before any of those other dates are due. But Jeff may have a comment on this one.
MR. BLAIR: Marjorie, you may be thinking of some things different than I would be thinking of. My thought is that in terms of figuring out how we wind up addressing the analysis of any samples, is that the most critical piece of that is the design of the form. And that piece felt like today's hearings gave a lot of input into that.
And I felt like when people were thinking of the form, part of their thinking was what information can we gather? How do we structure it so that could also gather some useful information? So I feel as if we've got a start on that.
MS. GREENBERG: I agree. Frankly, I just want to make sure that it's a reasonable assumption that we'll get some information from CMS. Right now, NCHS is not in a position to do a tabulation of these forms or what have you.
MR. BLAIR: This is implying that CMS is going to wind up doing some programming of this on a Web site.
MS. GREENBERG: I guess I'm the executive secretary, so I just want to make sure that we have a process.
DR. COHN: Before Brady comments, he gave me his card last night, and I was just reflecting that he is actually a senior statistician for his company, and might be able to provide us some very great assistance, advice, and might actually take the lead in terms of thinking about this one a little bit.
Brady, would you like to comment?
MR. AUGUSTINE: I was just thinking the use of the word sample is used vaguely. A lot of people say, oh sample, but not as many people would understand what that implies. And in this case, does the sampling mean that we will analyze data that is included on these forms? Or we will sample information from these forms from entities, and then go get further information from them?
Did it state that, or is that something we have to give guidance on?
DR. FITZMAURICE: We have to think about that.
MR. AUGUSTINE: Because if it's just information on the forms, there is really no sampling. We have everything. Of course that's if we can enter it administratively. Otherwise, we would have to develop a stratified type sample, where we'll take all of the administrative data that is entered on the Internet, and then a sample of the information that is on the handwritten forms, and then we'll have to kind of compile those, and get the lowest error rate possible.
DR. COHN: I was laughing, but I am looking to you. I do have a masters of public health in addition to a medical degree, but I really would defer to you in terms of I think potentially some thinking about all this. I don't think we need to come to an answer, but as we begin to come to closure on what the actual form design is, the question is how should we recommend that whatever analysis we do be structured, and what are we likely to get out it?
If you would be willing to take a lead on that, I think we would all be appreciative.
MR. AUGUSTINE: I can do so.
DR. COHN: Great.
MS. GREENBERG: NCVHS will work with you, obviously. This is a little unusual, this kind of responsibility being put in a law like this. And we have to figure out how we are going to do it.
DR. COHN: No, I think that's a very good point. I don't know that I have anything else on my list. I guess I would ask the subcommittee members or staff if there are any other issues? I guess we do have a two hour session at the end of February during a breakout, which I think will be primarily involved with PMRI, that letter, and review. If there is any time, there was I think some discussion about some e-health initiatives happening in government that might be up for some presentation or discussion. But I think that's sort of vague at this point.
MS. GREENBERG: Not for February; probably June.
DR. COHN: I'm talking about at the subcommittee level. We have a subcommittee period. There is a two hour subcommittee breakout. They won't be ready? Okay.
I guess the other question is whether at that point WEDI might be available to talk about the COSA(?) report, which as we know, got deferred from this last session, because the report was not final yet. So I think those would be the questions. We'll try to put something together around all of that.
And then it's the question of whether WEDI is ready. It's also the question for Jeff and Mike to think about, how long we think it's going to take for an modifications to the PMRI letter.
DR. FITZMAURICE: I'm hoping it's only going to be four, maybe five minutes.
DR. COHN: I think it's a pretty good letter at this point.
MR. BLAIR: I think the only things that I might mention about it is -- is Jean Narcisi in the room by any chance?
MS. GREENBERG: No, she left.
MR. BLAIR: Okay. Apparently, when we distributed the letter to WEDI, and they forwarded it on to some of the other associations that are affiliated with WEDI, the due date was incorrectly listed as February 24 instead of January 24. So there may be a few additional comments from groups that are associated or affiliated with WEDI. So I have asked them to please try to get those to me by email by the end of this next week, so I can distribute it to the rest of the folks, so we won't wind up being surprised at the full committee with new information.
Other than that, I am grateful for the good ideas. I'm very grateful for the support. I think the letter is in good shape.
DR. YASNOFF: The other quick clarification, our next meeting is April 9-10 of the subcommittee, is that correct?
DR. COHN: Yes, it is April 9-10. And we have a breakout on February 26 of the full committee. And then we another meeting of the subcommittee on May 29-30.
MS. GREENBERG: So WEDI is doing a report on code sets, that will be ready when?
DR. COHN: Well, I don't know.
MS. TRUDEL: It should be very soon. The report I think is essentially done, and they didn't have the opportunity to go through their full clearance process for today. So I think they were actually hoping that they might be able to get a slot in the February meeting.
DR. COHN: Well, that would be timely.
MS. TRUDEL: I'll talk to them about that.
DR. COHN: Okay. It sounds like we should be able to accommodate them.
Okay, any other comments? I want to express my appreciation to all of you. And obviously, Kepa, thank you for chairing the session yesterday despite illness. I once again want to welcome Brady Augustine to our subcommittee, and to the full committee, and welcome you on your first meeting.
With that, we will adjourn the meeting.
[Whereupon, the meeting was recessed at 12:30 pm.]