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HBMA Comments on: OIG Model Compliance Guidance - Letter to Ms. Brandt

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07/27/2000

News: July 27, 2000

Office of the Inspector General
Department of Health and Human Services
Attention: OIG-7P-CPG, Room 5246, Cohen Building
330 Independence Avenue S.W.
Washington, D.C. 20201

Attention: Kimberly Brandt, Office of Counsel to the Office of the Inspector General

Dear Ms. Brandt:

On behalf of the Healthcare Billing and Management Association (HBMA) we are pleased to submit the Association\'s official comments to the OIG\'s Draft Model Compliance Guidance for Physician Practices. HBMA has, for many years, vigorously advocated compliance to our members and their mostly physician clients and we were pleased that the OIG decided to issue a model compliance guidance for the physician community. It is our belief that with both parties to a third party billing relationship operating with organizational compliance programs HCFA\'s programs will be better protected, as will our members and their clients.

I. GENERAL COMMENTS

The OIG has provided practices and their business partners with a great deal of good, practical and thoughtful guidance on a myriad of complex topics. We commend the initial effort that developed the draft and hope that our comments and recommendations that follow are taken in the spirit in which they were prepared; to provide additional clarity, add missing content and insert more familiar language that will foster a desire among medical practices to develop and implement a compliance program.

A. CLARITY AND CONSISTENCY

Those of us who operate third party billing companies, like OIG personnel, are accustomed to the Medicare terminology, regulatory language, compliance jargon and \'government-speak\' that permeates our daily work life. The draft, while obviously making some effort to simplify the overall \'readability\' of the Model Guidance, is still filled with a regulatory lexicon and with references to rules and procedures that, in many cases, are not part of a practice\'s daily life or language.

RECOMMENDATION: We recommend that prior to issuance of the final version of the Model, a panel of representative physicians and billing professionals be invited to test and interpret the document to ensure that it will be readable and useful to the average medical practice. Our reading of the draft revealed many of the same references and phraseology that medical practices frequently misinterpret or read to match their conduct rather than the government\'s meaning.

B. PRACTICES WITHOUT INTERNET ACCESS

Throughout the Draft, there are consistent references and footnotes directing practices to resources within HCFA, OIG and other government agency\'s websites for additional information, updates and references. We applaud HCFA\'s efforts to \'open up\' access to information and materials that will allow practices to seek direct references to better guide their compliance efforts. However, we are concerned that, although it is estimated that 65% to 70% of practices have access the Internet to some degree, the remainder do not yet have Internet access. The model guidance offers the so-called \'non-wired\' practices no suggestions or recommendations on how the same information may be accessed. In fact, HBMA\'s \'non-wired\' members face the same access dilemma.

RECOMMENDATION: We recommend that the OIG develop alternative resource recommendations that will allow what may be viewed as \'old fashioned\' practices a way to access the same information offered via the Internet. We are concerned that without such a solution, practices without Internet access (for logistic, financial or technological reasons) cannot fully implement a valid compliance program. Subscriptions to a monthly or quarterly cumulative index or bibliography could be offered via a compliance mailing list (with or without a fee) rather than obliging practices to hunt and guess by making Freedom of Information Act (FOI) requests; FOI requests assume that the requester knows what to ask for and when to make a request.

C. DEFINITIONS

The use of some words, phrases and terminology in healthcare is constantly changing. Words and acronyms used commonly today were new or non-existent a year ago. New ones will inevitably be added, and some will have different meanings in the future. We feel that it is especially important for physicians, who are often less fluent in the lexicon of regulation and reimbursement, to be provided with a glossary or dictionary to assure that the meanings used by the OIG are consistent with their understanding.

For example: is a credit balance the same as an overpayment?; what is a lockbox?; etc.

RECOMMENDATION: The Model Guidance should have an appendix that provides clear definitions, as used by HCFA and/or the OIG, of key terms and phrases that may be clear to the authors but are confusing or unknown to the reader. Some thought might also be given to publishing a more general \'compliance dictionary\' for universal use as part of all industry segment compliance guidances.

D. FRAUDULENT OR \"ERRONEOUS\"

The draft makes repeated references to \'fraudulent and \"erroneous\"\' claims. It begins to appear early in the draft in a four paragraph passage that protests the OIG\'s undeserved (according to your author) reputation for being hostile toward providers. We found it curious, therefore, that the above phrase begins with \'fraudulent\' - a deliberate act you agree is not descriptive of most practices, because such phraseology typically lists the most common factor first. In fact, deliberate fraud is so unlikely in a practice with a compliance program - the intended audience of the OIG Model Guidance - we wondered why it was necessary at all.

RECOMMENDATION: The mere reversal of the words in the above phrase makes a remarkable difference in its apparent tone and meaning. Unless fraudulent is omitted entirely, we sincerely recommend that the words in this phrase be reversed so that they are more clearly consistent with the OIG\'s statements about its attitude toward honest and law abiding medical practices.

E. ESCHEAT, OSHA, EEOC, ADA, IRS, CLIA, etc.

The OIG is, understandably, focused on offering guidance to medical practices on development of a compliance program for claims submitted to federal programs. However, we believe that, similar to hospitals, nursing homes and other direct providers of health care services, medical practices have responsibilities to comply with a myriad of other federal and state laws and regulations. While we do not expect that the OIG\'s role includes providing advice on how to address non-federal matters, we believe that a credible compliance program will be judged on its overall content - including compliance with state escheat laws, OSHA, EEOC, ADA, IRS, CLIA and many others.

RECOMMENDATION: The final Model Guidance should, at least, indicate that a complete and credible compliance program will include compliance with other federal laws and regulations, as well as state and local laws and regulations. It would be helpful if the model offered at least a partial list of the items that may have the most impact or relevance to a medical practice.

F. CONFLICTS BETWEEN HCFA AND CARRIER POLICIES AND INTERPRETATIONS

HBMA members, as well as practices across America, have regularly noted significant disparities and discrepancies between published HCFA policies and regulatory interpretations and those of local Carriers. Even allowing for the permissible Local Medical Review Policies (LMRPs), practices and their billing companies are constantly challenged to maintain compliance when a clear and final answer to a billing or payment policy question is elusive, or impossible. We commend the OIG for acknowledging the issue in the Draft and for offering a practical, \'home-made\' remedy. However, this very significant issue should have a procedural answer, not a \'home-made\' one.

We hope that the development and implementation processes that will follow the release of the final version of this Guidance will lead to a resolution of these disparities and allow practices and their billing providers to work with a clear and consistent set of rules, not only for their locale, but across the Medicare program. Many of HBMA\'s member companies provide billing in more than one state and are often challenged to provide training for their staff and monitoring of employees\' work when the \'rules of the game\' are unpredictable or variable.

HBMA believes that persuading physician practices to implement and embrace an effective compliance program will be impeded by the cynicism that grows from many physicians\' observation that \"We\'re supposed to follow rules that they keep changing and hiding from us, and they (HCFA) can prosecute us anyway. Why bother trying?\" We urge the OIG and HCFA to heed the comments made in recent Congressional hearings that dealt with the complexity and confusion of participating in the Medicare program and make a conscious effort to streamline the policy making and communication processes. Our members are often the \'listening post\' to whom physicians direct their frustration and annoyance; we hope that we will soon have a more positive message to convey, instead of sharing their displeasure with a seemingly impenetrable system.

II. DETAILED COMMENTS

· \"I. C. The Difference Between Fraudulent and \"Erroneous\" Claims To Federal Health Programs

To these concerns, OIG would like to make the following points. First, we do not disparage physicians, other medical professionals or medical enterprises. In our view, the great majority of them are working ethically to render high quality medical care to our Medicare beneficiaries and to submit proper claims to Medicare.

Second, under the law, physicians are not subject to civil or criminal penalties for innocent errors, or even negligence. The Government\'s primary enforcement tool, the civil False Claims Act, covers only offenses that are committed with actual knowledge of the falsity of the claim, reckless disregard, or deliberate ignorance of the falsity of the claim.(6) The False Claims Act simply does not cover mistakes, errors, or negligence. The other major civil remedy available to the Federal Government, the Civil Monetary Penalties Law, has exactly the same standard of proof.(7) OIG is very mindful of the difference between innocent errors (\"erroneous claims\") on one hand, and reckless or intentional conduct (\"fraudulent claims\") on the other. For criminal penalties, the standard is even higher, criminal intent to defraud must be proved beyond a reasonable doubt. The Attorney General of the United States has stated, \"[i]t is not the [Justice Department\'s] policy to punish honest billing mistakes . . . [or] mere negligence. . . . These are not cases where we are seeking to punish someone for honest billing mistakes.\"(8)

Third, even ethical physicians (and their staffs) make billing mistakes and errors through inadvertence or negligence. When billing errors, honest mistakes, or negligence result in erroneous claims, the physician practice will be asked to return the funds erroneously claimed, but without penalties. In other words, erroneous claims result only in the return of funds claimed in error.

Fourth, innocent billing errors are a significant drain on the programs and all parties (physicians, providers, carriers, fiscal intermediaries, Government agencies, and beneficiaries) need to work cooperatively to reduce the overall error rate. But again, it should be emphasized that civil or criminal penalty action will not be initiated with respect to billing errors due to inadvertence or negligence, or for billings based on a negligent medical judgment.\"

COMMENT: HBMA hopes that the attitude and approach to enforcement expressed in the above paragraphs will soon be reflected in the attitude and approach of federal investigators (FBI, OIG, AUSA, etc.) in their dealings with providers, billing companies and others. It has been reported by our members that their dealings with the above federal authorities have often reflected an attitude of \'guilty until proven innocent,\' often related to inquiries into subjects which are easily understood by billing professionals and medical practice managers.

Members have reported incurring significant legal expenses and/or disruption of their business and/or their client\'s practice(s) by investigators, who, with only a small amount of prior investigation, or by direct inquiry, or armed with a better understanding of the normal conduct of business in the industry, could have determined that their concerns were unwarranted.

· \"II. A. The Seven Basic Compliance Elements

For example, larger practices can use both this guidance and the Third-Party Medical Billing Compliance Program Guidance to create a compliance program unique to the practice.(10)\"

COMMENT: HBMA agrees that the Model Guidance for Third Party Billing Companies has considerable applicability to the billing and compliance activities of larger practices. However, we also believe that small practices will benefit from following or referring to some portions of the Third Party Billing Guidance.

\"The OIG recognizes that physician practices need to find the best way to achieve compliance for their given circumstances. Specifically, the OIG encourages physician practices to participate in other compliance programs, such as the compliance programs of the hospitals or other settings in which the physicians practice. A physician\'s participation in another provider\'s compliance program could be a way, at least partly, to satisfy recommended elements of the physician\'s or physician practice\'s own compliance program. The OIG encourages this type of collaborative effort, where the content is appropriate to the setting involved, because it provides a means to promote the desired objective without imposing an undue burden or requiring physicians to undertake duplicative action.\"

COMMENT: We agree with the OIG\'s advocacy of collaboration. Many of our members have already offered to provide, or been asked by their clients to collaborate on, development of a mutual or joint Compliance Program. Not only is this approach more economical for each organization, the combined programs are likely to be more comprehensive and can be economically staffed at a higher professional level.

RECOMMENDATION: We recommend that all practices be advised to read and adopt applicable segments of the OIG\'s Model Guidance for Third Party Billing Companies.

· \"B. 1. Code of Conduct

The practice\'s expectations with respect to billing and coding, patient care, documentation, and payer relationships should be made clear to practice employees in the form of a code of conduct. This can also be succinctly stated in a practice mission statement. For example, employees should be told that the practice bills only for services that are actually rendered, codes accurately, documents medical necessity and appropriateness, and adheres to all payer contracts.\"

COMMENT 1: We believe that the above phrase \"documents medical necessity and appropriateness\" implies that practitioners should now begin to document patient care in a way that has never before been part of their normal documentation of patient care. Statements about the medical necessity or appropriateness of a service or procedure would appear to be artificial and self-serving and could be interpreted as a gratuitous attempt to self-justify billing. The long-established history of medical charts, including the years since coding became important, is that a chart is a communication between medical professionals who can readily interpret another\'s records and reach similar conclusions about the author\'s decisions and rationale.

RECOMMENDATION: This phrase should be removed.

COMMENT 2: We believe that the phrase \"adheres to all payer contracts\" is unnecessary. Contracts are a matter of law and judicial interpretation. A compliance program has no need to address matters that are governed by the courts as part of a private business arrangement. In addition, there have been widespread reports of, and state prosecution of, rampant non-compliance with payer contracts by the payers themselves. We are not advocates of so-called \'rough justice\' where a practice (or hospital, nursing home, etc.) invents its own remedy but we are concerned that this suggestion could create an environment in which payers will exploit providers\' own compliance commitment without a reciprocal commitment themselves.

RECOMMENDATION: This phrase should be amended to read: \"adheres to all government payer contracts.\"

· \"2. Policies and Procedures

Additionally, if the physician practice relies on a physician practice management company (PPMC) or management services organization (MSO), the practice can incorporate the compliance policies of those entities, if appropriate, into its own policies.\"

RECOMMENDATION: We suggest that the above sentence include reference to third party billing companies.

\"Physician practices can meet the goal of developing policies and procedures by: (1) developing a written compliance manual; and (2) updating clinical forms periodically to make sure they elicit the data required for the different levels of coding. All written policies and procedures should be tailored to the physician practice where they will be applied.\"

COMMENT: The phrase \"updating clinical forms periodically to make sure they elicit the data required for the different levels of coding\" is confusing, or inappropriate. The format of a practice\'s chart is matter of professional training, individual or group preference and necessity. It is appropriate to remind providers that their charts will be judged on the validity of their documentation of services billed. Suggesting that charts (or some other form) should be designed to itemize data for coding purposes (a purely billing-related activity) corrupts the historic purpose of a medical record. While we are sure that the suggestion was well meant, it seems intended to facilitate the work of an auditor, rather than strengthening the clinical value of a patient\'s chart.

RECOMMENDATION: We recommend that the above phrase be amended to read: \"periodically updating clinical forms to assure that they facilitate and encourage clear and complete documentation of patient care.\"

\"Areas in which a policy may be helpful to the practice include:

· employee hiring and retention;
· creation and maintenance of encounter forms, including the registration form, history and physical form and charge master (superbill and patient statement);
· coding and billing competency and responsibilities;
· correct coding initiatives;
· patient outreach and communication; and
· general marketing; and patient quality of care.\"

COMMENT 1: In the above bullet items the references are, for experienced compliance professionals, easily recognized and interpreted (e.g. hiring and retention relates to background checks, job descriptions, duty to report concerns, disciplinary procedures related to compliance, etc.). However, to the uninitiated, the meaning and significance of these items may seem oblique.

RECOMMENDATION: We suggest that these items be elaborated upon, with an outline (in the Appendices or footnotes, if necessary) or the text should explain and itemize the significance of the bulleted items.

COMMENT 2: Bullet # 2 also refers to the \"history and physical form\" and makes the same inference about the patient chart being \'designed\' to facilitate billing-related documentation. See our previous comments. In addition, the same bullet uses the terms \"charge master (superbill and patient statement);\" these terms, particularly when used together, are very confusing. The healthcare industry term \'charge master\' is one used almost exclusively by hospitals and will not resonate with practices, who normally refer to their counterpart as a \'fee schedule.\' The terms \"superbill and patient statement\" are well known to practices, but their significance are not made clear in the text or footnotes.

RECOMMENDATION: We suggest that Bullet # 2 be revised or more thoroughly explained.

COMMENT 3: The above bulleted list makes no reference to externally or internally developed clinical standards or treatment protocols, a device often used by federal authorities to judge the validity and medical necessity of a practices services.

RECOMMENDATON: We recommend that the list of Policies and Procedures be expanded to include a recommendation that practices developing a compliance program identify the (documented) clinical protocol(s), pathway(s), and other treatment guidelines followed by the practice. This will be particularly valuable to practices having access to nationally published reference materials related to the ever-changing approaches to managing certain conditions and diseases. While there can be differences of opinion about which protocol is most appropriate, a practice adhering to a published (even if internally developed) standard can more effectively monitor its own compliance and defend its practices, if audited.

\"Creating a resource manual from publicly available information may be a cost-effective approach for developing policies and procedures. For example, the practice can develop a \"binder\" that contains the practice\'s written policies and procedures, relevant HCFA directives and carrier bulletins, and summaries of informative OIG documents (e.g., Special Fraud Alerts, Advisory Opinions, inspection and audit reports). This binder should be regularly updated and should be accessible to all employees. It could also include a summary of the relevant reimbursement requirements of Federal and private payer plans (including those relating to reasonable and necessary services, coding and documentation). (12)In the case of more technical materials, it may be advisable to provide summaries in the handbook and make the source documents available upon request. If individualized copies of this handbook are not made available to all employees, then a reference copy should be available in a readily accessible location.\"

COMMENT: The above paragraph refers to \"relevant HCFA directives and carrier bulletins.\" This is a particular problem for practices using third party billing companies and for the billing industry, as well. Medicare Carriers are limited to using only one address for all mailings to practices - often referred to as the \'pay-to address.\' Since all mail goes to one address, the recipient of the mail can be only one of the parties to a dual relationship, leaving the other party at risk of being unaware of the changes or requirements announced in the Carrier Bulletin. Although HBMA has made repeated efforts advocating a remedy to this problem, none is in sight. In fact, billing companies using so-called \'lock box\' arrangements (a device advocated by HBMA and the OIG) have an additional challenge: many lock box banking services refuse to handle bulk mail (some have even referred to it as \'junk mail\') and discard it without forwarding it to the billing company or the practice.

RECOMMENDATION: We strongly urge the OIG to advocate and/or develop an independent mailing protocol that will assure that the practice and the third party billing company will receive all of the relevant Bulletins and other mailings that will allow the practice and their billing company to confidently rely on timely receipt of all HCFA directives.

If this problem is not properly addressed, we consider the Guidance\'s recommendation to be valid, but one which will be problematic for practices and billing companies for some time to come. Although some Carriers have begun to put their Bulletins on line, the number who have not currently outnumber those who have. And, of course, the \'non-wired\' practices are lost, as discussed earlier.

3. Specific Risk Areas

To assist physician practices in performing this initial assessment, the OIG has developed a list of potential risk areas affecting physician providers. These risk areas include: (a) coding and billing; (b) reasonable and necessary services; (c) documentation and (d) improper inducements, kickbacks and self-referrals. This list of risk areas is not exhaustive, or all encompassing. Rather, it should be viewed as a starting point for an internal review of potential vulnerabilities within the physician practice.(13) The objective of such an assessment should be to ensure that key personnel in the physician practice is aware of these risk areas and that steps are taken to minimize, to the extent possible, the types of problems identified. While there are many ways to accomplish this objective, clear written policies and procedures that are communicated to all employees are important to ensure the effectiveness of a compliance program. Specifically, the following are discussions of risk areas for physicians:(14)\"

COMMENT 1: The above list of four broad categories is far too limited and will, in our opinion, lead to misunderstanding, misinterpretation and insufficient attention to the important details that are a vital part of an effective compliance program.

RECOMMENDATION: We encourage the OIG to provide a more comprehensive risk assessment checklist. While no list can be comprehensive or cover all of the variables and permutations that affect practices, we believe that there are more than four, and official guidance would be most helpful to practices.

We are particularly concerned that the Guidance makes inadequate reference to, and provides insufficient practical examples of, improper inducements and other Stark and Anit-Kickback violations, particularly as they may apply to solo or small practices.

COMMENT 2: \"The objective of such an assessment should be to ensure that key personnel in the physician practice is aware of these risk areas and that steps are taken to minimize, to the extent possible, the types of problems identified.\" The grammar in the previous sentence should be corrected.

RECOMMENDATION: The above sentence should be edited to add \"correct and \"preceding \"minimize.\"

a. Coding and Billing

The identification of risk areas associated with coding and billing should be a major part of any physician practice\'s compliance program.

The following risk areas associated with billing have been among the most frequent subjects of investigations and audits by the OIG:

· billing for items or services not rendered or not provided as claimed;(15)

COMMENT 1: The footnoted example is one of deliberate fraud. A better example would demonstrate how an erroneous claim could result from inattention, such as an incomplete service billed without a -53 modifier, or an automated charge assigned to a patient whose service was ordered but never performed.

· submitting claims for equipment, medical supplies and services that are not reasonable and necessary;(16)

COMMENT 2: The footnote and reference to Appendix A each imply that practices should self-adjudicate (apply Medicare\'s criteria, some of which are unknown [i.e. the so-called \'black box edits]) their own claims, even when the practice has a good faith disagreement with the Carrier\'s and/or HCFA\'s rned that, as written, the OIG will expect practices to self-limit their claim submissions, based on Carrier\'s system deficiencies, rather than on objective medical necessity criteria.

We recognize that there ARE medically unnecessary services provided, measured against clinically objective standards. The guidance makes no such distinction, and should. Good clinicians should practice good medicine and bill accordingly; the fact that Medicare and others make expedient decisions about payment simply demonstrates that there are economic differences of opinion. We are offended that Guidance infers that bona fide clinical opinions are relegated to being deliberate efforts to \'game\' the system.

· double billing;(17)

COMMENT: We have regularly noted that this phrase is incomplete and should only be used in its longer form: \"double billing in an effort to secure duplicate payment.\" Practices and HBMA members across the U.S. have the regular experience of having to submit the same claim two, three or more times in order to secure one payment. We are concerned that the language proposed could be used to interfere with a practice\'s legitimate effort to secure initial payment, and payer\'s potential exploitation of the abbreviated term to coerce practices and their billers to forfeit payment when the initial claim was lost or destroyed by the payer.

In addition, the footnote makes reference to \"when another party bills the Federal health care program for an item or service also billed by the physician.\" We wonder how a practice could know what another entity has, or will, bill. In fact, such knowledge could imply, or be evidence of, collusion, fee splitting, violation of HIPAA privacy rules, kickbacks and other regulations.

· billing for non-covered services as if covered;

COMMENT: This item is not footnoted, but should be. The most common illustration of the issue is to bill Medicare using a covered office visit code (9920x or 9921x) when the actual service was a non-covered annual physical. HBMA members report that this is a frequently used technique among some practices, who excuse their behavior as \'concern for the beneficiaries who cannot afford the (much needed) annual check-up and who will not follow the provider\'s regimen if it is not covered.\' Providers should be reminded that necessary does not equal covered and that misrepresentation is just that.

· knowing misuse of provider identification numbers, which results in improper billing;(18)

COMMENT: The example used in the footnote is a poor illustration of the type of behavior that is violative of billing compliance. A simple example would be billing for a service performed by Dr. B, who has not yet been issued a Medicare provider number, using Dr. A\'s Medicare provider number. HBMA members report frequent instances of pressure from client practices to engage in the above practice, often because of extremely long delays in the issuance of provider numbers by some Medicare Carriers and, in particular, by Medicaid programs. The footnote will lead the reader to a section of the CFR and/or the Carrier\'s Manual that are very technically worded, and which do not clearly indicate or explain the prohibition mentioned above.

· billing for unbundled services;(19)
· failure to properly use coding modifiers;(20)

COMMENT 1: The footnote directs practices to refer to \"the Medicare Carrier Manual\" when it should say \"the Medicare Provider Manual.\" The footnote also suggests that practices \"consult the National Correct Coding Initiative (NCCI) system.\" We know of no \'system\' to consult. There are a number of (expensive) proprietary products marketed, and some billing software includes the NCCI edits as part of the package, but many, if not most practices, do not have access to a \'system,\' as referenced in the footnote.

There are reference manuals marketed (paper and electronic), and NCCI can be downloaded, but these options are not mentioned in the footnote, but should be. Many of the options available are unaffordable for small practices. In addition, the updates and errata found in NCCI edits are frequently not communicated to providers, and in some cases to payers, to assure that a practice knows all that it should.

COMMENT 2: HMBA member firms and their clients regularly report that many Carriers do not accept all nationally published modifiers, leaving practices and their billers frustrated by the inability to fully and precisely report services. We are concerned that these Carrier deficiencies are being used to improperly discredit claims as \'medically unnecessary\' or invalid in other ways, merely because the submitted modifier is incompatible with a Carrier\'s adjudication software.

· upcoding the level of service provided.(21)

COMMENT: This footnote is inflammatory. \"Dr. X defrauds Medicare…\" makes it clear that the OIG views any discrepancy between the code billed and a lower code assigned by an auditor to have been a deliberate act (fraud) by the provider, rather than a difference of opinion (error) between the provider and the auditor. We recognize that some practices DO engage in conscious \'upcoding.\' We believe, however, that far more often, the discrepancy is in the amount of documentation recorded (under-documentation) rather than the level of care actually rendered. The footnote\'s characterization fails to recognize legitimate differences of opinion, even though the result would still be an improper payment that would have to be corrected.

Members of HBMA\'s Coding Subcommittee (of the Ethics and Compliance Committee) have also noted that the audit tools used by Carriers, OIG, DOJ, FBI and others are not common to all organizations, and, area to area, are not following a standardized set of criteria, even when the audit tool is the same. Providers are understandably confused and frustrated by a review and audit process that is often inconsistent and is often based on incorrect knowledge and/or application of the HCFA/AMA Documentation Guidelines. Implementation of a practice compliance program should be based on following as much objective criteria as possible, knowing that it will be audited and enforced on an objective and consistent basis, as well.

Practices operating in multi-state markets (urban areas with multi-state offices, regional practices, rural areas near borders, etc.) report significant differences in instructions and/or interpretations from different Carriers or enforcement agencies. We are concerned that HCFA or the OIG will expect a provider to \'keep track\' of how to document and code when the provider may practice in different offices - and states - on different days.

\"The written policies and procedures concerning proper coding should reflect the current reimbursement principles set forth in applicable statutes, regulations(22) and Federal, State or private payer health care program requirements and should be developed in tandem with coding and billing standards used in the physician practice. Furthermore, written policies and procedures should ensure that coding and billing are based on medical record documentation. Particular attention should be paid to issues of appropriate diagnosis codes and individual Medicare Part B claims (including documentation guidelines for evaluation and management services).(23) The physician practice should also institute a policy that all rejected claims pertaining to diagnosis and procedure codes be reviewed by the coder. This should facilitate a reduction in similar errors.\"

COMMENT: The phrase \"The physician practice should also institute a policy that all rejected claims pertaining to diagnosis and procedure codes be reviewed by the coder\" may lead to confusion. Less than 30% of practices have an employee designated as a \'coder.\' Taken literally, a practice with no coder could conclude that rejected claims need not be reviewed. Even though the provider is the coder in such instances, the Guidance is ambiguous in its message and should be clarified. Even in practices WITH a coder, we believe that the provider should be involved in such reviews.

RECOMMENDATION: Insert the words \"and/or provider\" to this sentence.

b. Reasonable and Necessary Services

The compliance program should provide guidance that claims be submitted only for services that the physician practice finds to be reasonable and necessary in the particular case. The OIG recognizes that physicians should be able to order any tests, including screening tests, they believe are appropriate for the treatment of their patients. However, the physician practice should be aware that Medicare will only pay for services that meet the Medicare definition of reasonable and necessary.(24)

Medicare (and many insurance plans) may deny payment for a service that the physician believes is clinically appropriate, but which is not reasonable and necessary. Thus, when a physician provides services to a patient, he or she should only bill those services believed to be reasonable and necessary for the diagnosis and treatment of a patient. Upon request, the physician practice should be able to provide documentation, such as a patient\'s medical records and physician\'s orders, to support the appropriateness of a service that the physician has provided.

COMMENT: The above two paragraphs relate to our comments regarding Footnote 16. The paragraphs, read together, strongly infer that only Medicare and its Carriers are the arbiters of what is medically necessary. We clearly recognize Medicare\'s (and other payers\') right to determine what it covers (including the statute cited in Footnote 24), but to characterize any and all differences in coverage or payment policy as \"billing for services that are not medically necessary\" is offensive, unwarranted and self-serving.

Practices should not be expected, as a condition of having a valid compliance program, to self-adjudicate their claims according to Medicare\'s economically limited criteria, payers\' sometimes arbitrary or unpublished Local Medical Review Policies (LMRPs), or be forced to withhold services (creating other, more onerous risks) to avoid providing service(s) Medicare deems medically unnecessary. In an ideal world, all of Medicare\'s policies would be clear, objective and fair; experience has proved otherwise.

RECOMMENDATION: We recognize the challenge of rewriting the above paragraphs in a way that balances Medicare\'s right to make coverage decisions AND to not pay for services that are objectively unnecessary or experimental in balance with providers\' right to care for patients according to their medical judgment and training, despite payer\'s limitations of coverage. It is important, however, to strongly urge the OIG to reword these paragraphs in a way that acknowledges there will be differences of opinion that do not demonstrate that a provider is providing medically unnecessary services, only services that Medicare does not cover and instances where Medicare\'s medical necessity standard differs from other published standards.



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