III. Conclusion

Just as immunizations are given to patients to prevent them from becoming ill, physician practices may view the implementation of a voluntary compliance program as comparable to a form of preventive medicine for the practice. This voluntary compliance program guidance is intended to assist physician practices in developing and implementing internal controls and procedures that promote adherence to Federal health care program requirements.

As stated earlier, physician compliance programs do not need to be time or resource intensive and can be developed in a manner that best reflects the nature of each individual practice. Many of the recommendations set forth in this document are ones that many physician practices already have in place and are simply good business practices that can be adhered to with a reasonable amount of effort. By implementing an effective compliance program, appropriate for its size and resources, and making compliance principles an active part of the practice culture, a physician practice can help prevent and reduce erroneous or fraudulent conduct in its practice. These efforts can also streamline and improve the business operations within the practice and therefore innoculate itself against future problems.

Dated: September 27, 2000. June Gibbs Brown, Inspector General.

Endnotes

(1) For the purpose of this guidance, the term "physician" is defined as: (1) a doctor of medicine or osteopathy; (2) a doctor of dental surgery or of dental medicine; (3) a podiatrist; (4) an optometrist; or (5) a chiropractor, all of whom must be appropriately licensed by the State. 42 U.S.C. 1395x(r).

(2) Much of this guidance can also apply to other independent practitioners, such as psychologists, physical therapists, speech language pathologists, and occupational therapists.

(3) Currently, the OIG has issued compliance program guidance for the following eight industry sectors: hospitals, clinical laboratories, home health agencies, durable medical equipment suppliers, third-party medical billing companies, hospices, Medicare+Choice organizations offering coordinated care plans, and nursing facilities. The guidance listed here and referenced in this document is available on the OIG web site at http://www.hhs.gov/oig in the Electronic Reading Room or by calling the OIG Public Affairs office at (202) 619-1343.

(4) The OIG has issued Advisory Opinions responding to specific inquiries concerning the application of the OIG's authorities, in particular, the anti-kickback statute, and Special Fraud Alerts setting forth activities that raise legal and enforcement issues. These documents, as well as reports from the OIG's Office of Audit Services and Office of Evaluation and Inspections can be obtained via the Internet address or phone number provided in Footnote 3. Physician practices can also review the Health Care Financing Administration (HCFA) web site on the Internet at http:// www.hcfa.gov, for up-to-date regulations, manuals, and program memoranda related to the Medicare and Medicaid programs.

(5) 31 U.S.C. 3729.

(6) 42 U.S.C. 1320a-7a.

(7) See Appendix D.II. referencing the Provider Self-Disclosure Protocol for information on how to conduct a baseline audit.

(8) Physician practices with laboratories or arrangements with third-party billing companies can also check the risk areas included in the OIG compliance program guidance for those industries.

(9) The OIG and HCFA are working to compile a list of basic documents issued by both entities that could be included in such a binder. We expect to complete this list later this fall, and will post it on the OIG and HCFA web sites, as well as publicize this list to physician organizations and representatives (information on how to contact the OIG is contained in Footnote 3; HCFA information can be obtained at www.hcfa.gov/medlearn or by calling 1-800-MEDICARE).

(10) Physician practices seeking additional guidance on potential risk areas can review the OIG's Work Plan to identify vulnerabilities and risk areas on which the OIG will focus in the future. In addition, physician practices can also review the OIG's semiannual reports, which identify program vulnerabilities and risk areas that the OIG has targeted during the preceding six months. All of these documents are available on the OIG's webpage at http:// www.hhs.gov/oig.

(11) Appendix A of this document lists additional risk areas that a physician practice may want to review and incorporate into their practice standards and procedures.

(12) For example, Dr. X, an ophthalmologist, billed for laser surgery he did not perform. As one element of proof, he did not even have laser equipment or access to such equipment at the place of service designated on the claim form where he performed the surgery.

(13) Billing for services, supplies and equipment that are not reasonable and necessary involves seeking reimbursement for a service that is not warranted by a patient's documented medical condition. See 42 U.S.C. 1395i(a)(1)(A) ("no payment may be made under part A or part B [of Medicare] for any expenses incurred for items or services which * * * are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of the malformed body member"). See also Appendix A for further discussion on this topic.

(14) Double billing occurs when a physician bills for the same item or service more than once or another party billed the Federal health care program for an item or service also billed by the physician. Although duplicate billing can occur due to simple error, the knowing submission of duplicate claims--which is sometimes evidenced by systematic or repeated double billing--can create liability under criminal, civil, and/or administrative law.

(15) For example, Dr. Y bills Medicare using a covered office visit code when the actual service was a non-covered annual physical. Physician practices should remember that "necessary" does not always constitute "covered" and that this example is a misrepresentation of services to the Federal health care programs.

(16) An example of this is when the practice bills for a service performed by Dr. B, who has not yet been issued a Medicare provider number, using Dr. A's Medicare provider number. Physician practices need to bill using the correct Medicare provider number, even if that means delaying billing until the physician receives his/her provider number.

(17) Unbundling is the practice of a physician billing for multiple components of a service that must be included in a single fee. For example, if dressings and instruments are included in a fee for a minor procedure, the provider may not also bill separately for the dressings and instruments.

(18) A modifier, as defined by the CPT-4 manual, provides the means by which a physician practice can indicate a service or procedure that has been performed has been altered by some specific circumstance, but not changed in its definition or code. Assuming the modifier is used correctly and appropriately, this specificity provides the justification for payment for those services. For correct use of modifiers, the physician practice should reference the appropriate sections of the Medicare Provider Manual. See Medicare Carrier Manual Section 4630. For general information on the correct use of modifiers, a physician practice can consult the National Correct Coding Initiative (NCCI). See Appendix F for information on how to download the NCCI edits. The NCCI coding edits are updated on a quarterly basis and are used to process claims and determine payments to physicians.

(19) This is the practice of coding/charging one or two middle levels of service codes exclusively, under the philosophy that some will be higher, some lower, and the charges will average out over an extended period (in reality, this overcharges some patients while undercharging others).

(20) Upcoding is billing for a more expensive service than the one actually performed. For example, Dr. X intentionally bills at a higher evaluation and management (E&M) code than what he actually renders to the patient.

(21) The official coding guidelines are promulgated by HCFA, the National Center for Health Statistics, the American Hospital Association, the American Medical Association and the American Health Information Management Association. See International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9 CM)(and its successors); 1998 Health Care Financing Administration Common Procedure Coding System (HCPCS) (and its successors); and Physicians' CPT. In addition, there are specialized coding systems for specific segments of the health care industry. Among these are ADA (for dental procedures), DSM IV (psychiatric health benefits) and DMERCs (for durable medical equipment, prosthetics, orthotics and supplies).

(22) The failure of a physician practice to: (i) document items and services rendered; and (ii) properly submit the corresponding claims for reimbursement is a major area of potential erroneous or fraudulent conduct involving Federal health care programs. The OIG has undertaken numerous audits, investigations, inspections and national enforcement initiatives in these areas.

(23) "* * * for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member." 42 U.S.C. 1395y(a)(1)(A).

(24) For additional information on proper documentation, physician practices should also reference the Documentation Guidelines for Evaluation and Management Services, published by HCFA. Currently, physicians may document based on the 1995 or 1997 E&M Guidelines, whichever is most advantageous to the physician. A new set of draft guidelines were announced in June 2000, and are undergoing pilot testing and revision, but are not in current use.

(25) The anti-kickback statute provides criminal penalties for individuals and entities that knowingly offer, pay, solicit, or receive bribes or kickbacks or other remuneration in order to induce business reimbursable by Federal health care programs. See 42 U.S.C. 1320a-7b(b). Civil penalties, exclusion from participation in the Federal health care programs, and civil False Claims Act liability may also result from a violation of the prohibition. See 42 U.S.C. 1320a-7a(a)(5), 42 U.S.C. 1320a-7(b)(7), and 31 U.S.C. 3729-3733.

(26) The physician self-referral law, 42 U.S.C. 1395nn (also known as the "Stark law"), prohibits a physician from making a referral to an entity with which the physician or any member of the physician's immediate family has a financial relationship if the referral is for the furnishing of designated health services, unless the financial relationship fits into an exception set forth in the statute or implementing regulations.

(27) See Appendix B for additional information on the anti-kickback statute.

(28) The OIG's definition of "fair market value" excludes any value attributable to referrals of Federal program business or the ability to influence the flow of such business. See 42 U.S.C. 1395nn(h)(3). Adhering to the rule of keeping business arrangements at fair market value is not a guarantee of legality, but is a highly useful general rule.

(29) See 42 U.S.C. 1320a-7a(a)(5).

(30) In the OIG Special Fraud Alert "Routine Waiver of Part B Co-payments/Deductibles" (May 1991), the OIG describes several reasons why routine waivers of these cost-sharing amounts pose concerns. The Alert sets forth the circumstances under which it may be appropriate to waive these amounts. See also 42 U.S.C. 1320a-7a(a)(5).

(31) All physician contracts and agreements with parties in a position to influence Federal health care program business or to whom the doctor is in such a position to influence should be reviewed to avoid violation of the anti-kickback, self-referral, and other relevant Federal and State laws. The OIG has published safe harbors that define practices not subject to the anti-kickback statute, because such arrangements would be unlikely to result in fraud or abuse. Failure to comply with a safe harbor provision does not make an arrangement per se illegal. Rather, the safe harbors set forth specific conditions that, if fully met, would assure the entities involved of not being prosecuted or sanctioned for the arrangement qualifying for the safe harbor. One such safe harbor applies to personal services contracts. See 42 CFR 1001.952(d).

(32) See OIG Special Fraud Alert "Joint Venture Arrangements" (August 1989) available on the OIG web site at http://www.hhs.gov/oig. See also OIG Advisory Opinion 97-5.

(33) Physician practices should establish clear standards and procedures governing gift-giving because such exchanges may be viewed as inducements to influence business decisions.

(34) There are various Federal regulations governing the privacy of patient records and the retention of certain types of patient records. Many states also have record retention statutes. Practices should check with their state medical society and/or affiliated professional association for assistance in ascertaining these requirements for their particular specialty and location.

(35) The HHS-OIG "List of Excluded Individuals/Entities" provides information to health care providers, patients, and others regarding individuals and entities that are excluded from participation in Federal health care programs. This report, in both an on-line searchable and downloadable database, can be located on the Internet at http://www.hhs.gov/oig. The OIG sanction information is readily available to users in two formats on over 15,000 individuals and entities currently excluded from program participation through action taken by the OIG. The on-line searchable database allows users to obtain information regarding excluded individuals and entities sorted by: (1) The legal bases for exclusions; (2) the types of individuals and entities excluded by the OIG; and (3) the States where excluded individuals reside or entities do business. In addition, the General Services Administration maintains a monthly listing of debarred contractors, "List of Parties Debarred from Federal Programs," at http://www.arnet.gov/epls.

(36) HCFA also offers free online training for general fraud and abuse issues at http://www.hcfa.gov/medlearn. See Appendix F for additional information.

(37) As noted earlier in this guidance, another way for physician practices to receive training is for the physicians and/or the employees of the practice to attend training programs offered by outside entities, such as a hospital, a local medical society or a carrier. This sort of collaborative effort is an excellent way for the practice to meet the desired training objective without having to expend the resources to develop and implement in-house training.

(38) Some publications, such as OIG's Special Fraud Alerts, audit and inspection reports, and Advisory Opinions are readily available from the OIG and can provide a basis for educational courses and programs for physician practice employees. See Appendix F for a partial listing of these documents. See Footnote 3 for information on how to obtain copies of these documents.

(39) Currently, the OIG is monitoring a significant number of corporate integrity agreements that require many of these training elements. The OIG usually requires a minimum of one hour annually for basic training in compliance areas. Additional training may be necessary for specialty fields such as claims development and billing.

(40) Instances of noncompliance must be determined on a case-by-case basis. The existence or amount of a monetary loss to a health care program is not solely determinative of whether the conduct should be investigated and reported to governmental authorities. In fact, there may be instances where there is no readily identifiable monetary loss to a health care provider, but corrective actions are still necessary to protect the integrity of the applicable program and its beneficiaries, e.g., where services required by a plan of care are not provided.

(41) The physician practice may seek advice from its legal counsel to determine the extent of the practice's liability and to plan the appropriate course of action.

(42) The OIG has established a Provider Self-Disclosure Protocol that encourages providers to voluntarily report suspected fraud. The concept of voluntary self-disclosure is premised on a recognition that the Government alone cannot protect the integrity of the Medicare and other Federal health care programs. Health care providers must be willing to police themselves, correct underlying problems, and work with the Government to resolve these matters. The Provider Self-Disclosure Protocol can be located on the OIG's web site at: www.hhs.gov/oig. See Appendix D for further information on the Provider Self-Disclosure Protocol.

(43) In addition to whatever other method of communication is being utilized, the OIG recommends that physician practices post the HHS-OIG Hotline telephone number (1-800-HHS-TIPS) in a prominent area.

(44) See Footnote 35 for information on how to access these lists.

(1) HCFA has recently developed a web site which, when completed by the end of the year 2000, will contain the LMRPs for each of the contractors across the country. The web site can be accessed at http://www.lmrp.net.

(2) The relevant manual provisions are located at MCM, Part III, Secs. 7300 and 7320. This section of the manual also includes the carrier's recommended form of an ABN.

(3) See 42 U.S.C. 1395dd(a).

(4) See 42 U.S.C. 1395dd(b)(1).

(5) See 42 U.S.C. 1395dd(b)(2) and (3).

(6) See 42 U.S.C. 1395dd(c)(1)(A).

(7) Hospitals and physicians, including on-call physicians, who violate the statute may face penalties that include civil fines of up to $50,000 (or not more than $25,000 in the case of a hospital with less than 100 beds) per violation, and physicians may be excluded from participation in the Federal health care programs.

(8) 42 CFR 415.150 through 415.190.

(9) 42 CFR 415.174.

(10) Id.

(11) This section is not intended to be and is not a complete reference for teaching physicians. It is strongly recommended that those physicians who practice in a teaching setting consult their respective hospitals for more guidance.

(12) This concern is noted in Advisory Opinion No. 98-4 and also the Office of Inspector General Compliance Program Guidance for Third-Party Medical Billing Companies. Both are available on the OIG web site at http://www.hhs.gov/oig.

(1) Available through the OIG web site at http://www.hhs.gov/oas/ratstat.html.

(1) For the purpose of this guidance, the term "physician" is defined as: (1) a doctor of medicine or osteopathy; (2) a doctor of dental surgery or of dental medicine; (3) a podiatrist; (4) an optometrist; or (5) a chiropractor, all of whom must be appropriately licensed by the State. 42 U.S.C. 1395x(r).

(2) Much of this guidance can also apply to other independent practitioners, such as psychologists, physical therapists, speech language pathologists, and occupational therapists.

(3) Currently, the OIG has issued compliance program guidance for the following eight industry sectors: hospitals, clinical laboratories, home health agencies, durable medical equipment suppliers, third-party medical billing companies, hospices, Medicare+Choice organizations offering coordinated care plans, and nursing facilities. The guidance listed here and referenced in this document is available on the OIG web site at http://www.hhs.gov/oig in the Electronic Reading Room or by calling the OIG Public Affairs office at (202) 619-1343.

(4) The OIG has issued Advisory Opinions responding to specific inquiries concerning the application of the OIG's authorities, in particular, the anti-kickback statute, and Special Fraud Alerts setting forth activities that raise legal and enforcement issues. These documents, as well as reports from the OIG's Office of Audit Services and Office of Evaluation and Inspections can be obtained via the Internet address or phone number provided in Footnote 3. Physician practices can also review the Health Care Financing Administration (HCFA) web site on the Internet at http://www.hcfa.gov, for up-to-date regulations, manuals, and program memoranda related to the Medicare and Medicaid programs.

(5) 31 U.S.C. 3729.

(6) 42 U.S.C. 1320a-7a.

(7) See Appendix D.II. referencing the Provider Self-Disclosure Protocol for information on how to conduct a baseline audit.

(8) Physician practices with laboratories or arrangements with third-party billing companies can also check the risk areas included in the OIG compliance program guidance for those industries.

(9) The OIG and HCFA are working to compile a list of basic documents issued by both entities that could be included in such a binder. We expect to complete this list later this fall, and will post it on the OIG and HCFA web sites, as well as publicize this list to physician organizations and representatives (information on how to contact the OIG is contained in Footnote 3; HCFA information can be obtained at www.hcfa.gov/medlearn or by calling 1-800-MEDICARE).

(10) Physician practices seeking additional guidance on potential risk areas can review the OIG's Work Plan to identify vulnerabilities and risk areas on which the OIG will focus in the future. In addition, physician practices can also review the OIG's semiannual reports, which identify program vulnerabilities and risk areas that the OIG has targeted during the preceding six months. All of these documents are available on the OIG's webpage at http:// www.hhs.gov/oig.

(11) Appendix A of this document lists additional risk areas that a physician practice may want to review and incorporate into their practice standards and procedures.

(12) For example, Dr. X, an ophthalmologist, billed for laser surgery he did not perform. As one element of proof, he did not even have laser equipment or access to such equipment at the place of service designated on the claim form where he performed the surgery.

(13) Billing for services, supplies and equipment that are not reasonable and necessary involves seeking reimbursement for a service that is not warranted by a patient's documented medical condition. See 42 U.S.C. 1395i(a)(1)(A) ("no payment may be made under part A or part B [of Medicare] for any expenses incurred for items or services which * * * are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of the malformed body member"). See also Appendix A for further discussion on this topic.

(14) Double billing occurs when a physician bills for the same item or service more than once or another party billed the Federal health care program for an item or service also billed by the physician. Although duplicate billing can occur due to simple error, the knowing submission of duplicate claims--which is sometimes evidenced by systematic or repeated double billing--can create liability under criminal, civil, and/or administrative law.

(15) For example, Dr. Y bills Medicare using a covered office visit code when the actual service was a non-covered annual physical. Physician practices should remember that "necessary" does not always constitute "covered" and that this example is a misrepresentation of services to the Federal health care programs.

(16) An example of this is when the practice bills for a service performed by Dr. B, who has not yet been issued a Medicare provider number, using Dr. A's Medicare provider number. Physician practices need to bill using the correct Medicare provider number, even if that means delaying billing until the physician receives his/her provider number.

(17) Unbundling is the practice of a physician billing for multiple components of a service that must be included in a single fee. For example, if dressings and instruments are included in a fee for a minor procedure, the provider may not also bill separately for the dressings and instruments.

(18) A modifier, as defined by the CPT-4 manual, provides the means by which a physician practice can indicate a service or procedure that has been performed has been altered by some specific circumstance, but not changed in its definition or code. Assuming the modifier is used correctly and appropriately, this specificity provides the justification for payment for those services. For correct use of modifiers, the physician practice should reference the appropriate sections of the Medicare Provider Manual. See Medicare Carrier Manual Section 4630. For general information on the correct use of modifiers, a physician practice can consult the National Correct Coding Initiative (NCCI). See Appendix F for information on how to download the NCCI edits. The NCCI coding edits are updated on a quarterly basis and are used to process claims and determine payments to physicians.

(19) This is the practice of coding/charging one or two middle levels of service codes exclusively, under the philosophy that some will be higher, some lower, and the charges will average out over an extended period (in reality, this overcharges some patients while undercharging others).

(20) Upcoding is billing for a more expensive service than the one actually performed. For example, Dr. X intentionally bills at a higher evaluation and management (E&M) code than what he actually renders to the patient.

(21) The official coding guidelines are promulgated by HCFA, the National Center for Health Statistics, the American Hospital Association, the American Medical Association and the American Health Information Management Association. See International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9 CM)(and its successors); 1998 Health Care Financing Administration Common Procedure Coding System (HCPCS) (and its successors); and Physicians' CPT. In addition, there are specialized coding systems for specific segments of the health care industry. Among these are ADA (for dental procedures), DSM IV (psychiatric health benefits) and DMERCs (for durable medical equipment, prosthetics, orthotics and supplies).

(22) The failure of a physician practice to: (i) document items and services rendered; and (ii) properly submit the corresponding claims for reimbursement is a major area of potential erroneous or fraudulent conduct involving Federal health care programs. The OIG has undertaken numerous audits, investigations, inspections and national enforcement initiatives in these areas.

(23) "* * * for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member." 42 U.S.C. 1395y(a)(1)(A).

(24) For additional information on proper documentation, physician practices should also reference the Documentation Guidelines for Evaluation and Management Services, published by HCFA. Currently, physicians may document based on the 1995 or 1997 E&M Guidelines, whichever is most advantageous to the physician. A new set of draft guidelines were announced in June 2000, and are undergoing pilot testing and revision, but are not in current use.

(25) The anti-kickback statute provides criminal penalties for individuals and entities that knowingly offer, pay, solicit, or receive bribes or kickbacks or other remuneration in order to induce business reimbursable by Federal health care programs. See 42 U.S.C. 1320a-7b(b). Civil penalties, exclusion from participation in the Federal health care programs, and civil False Claims Act liability may also result from a violation of the prohibition. See 42 U.S.C. 1320a-7a(a)(5), 42 U.S.C. 1320a-7(b)(7), and 31 U.S.C. 3729-3733.

(26) The physician self-referral law, 42 U.S.C. 1395nn (also known as the "Stark law"), prohibits a physician from making a referral to an entity with which the physician or any member of the physician's immediate family has a financial relationship if the referral is for the furnishing of designated health services, unless the financial relationship fits into an exception set forth in the statute or implementing regulations.

(27) See Appendix B for additional information on the anti-kickback statute.

(28) The OIG's definition of "fair market value" excludes any value attributable to referrals of Federal program business or the ability to influence the flow of such business. See 42 U.S.C. 1395nn(h)(3). Adhering to the rule of keeping business arrangements at fair market value is not a guarantee of legality, but is a highly useful general rule.

(29) See 42 U.S.C. 1320a-7a(a)(5).

(30) In the OIG Special Fraud Alert "Routine Waiver of Part B Co-payments/Deductibles" (May 1991), the OIG describes several reasons why routine waivers of these cost-sharing amounts pose concerns. The Alert sets forth the circumstances under which it may be appropriate to waive these amounts. See also 42 U.S.C. 1320a-7a(a)(5).

(31) All physician contracts and agreements with parties in a position to influence Federal health care program business or to whom the doctor is in such a position to influence should be reviewed to avoid violation of the anti-kickback, self-referral, and other relevant Federal and State laws. The OIG has published safe harbors that define practices not subject to the anti-kickback statute, because such arrangements would be unlikely to result in fraud or abuse. Failure to comply with a safe harbor provision does not make an arrangement per se illegal. Rather, the safe harbors set forth specific conditions that, if fully met, would assure the entities involved of not being prosecuted or sanctioned for the arrangement qualifying for the safe harbor. One such safe harbor applies to personal services contracts. See 42 CFR 1001.952(d).

(32) See OIG Special Fraud Alert "Joint Venture Arrangements" (August 1989) available on the OIG web site at http://www.hhs.gov/oig. See also OIG Advisory Opinion 97-5.

(33) Physician practices should establish clear standards and procedures governing gift-giving because such exchanges may be viewed as inducements to influence business decisions.

(34) There are various Federal regulations governing the privacy of patient records and the retention of certain types of patient records. Many states also have record retention statutes. Practices should check with their state medical society and/or affiliated professional association for assistance in ascertaining these requirements for their particular specialty and location.

(35) The HHS-OIG "List of Excluded Individuals/Entities" provides information to health care providers, patients, and others regarding individuals and entities that are excluded from participation in Federal health care programs. This report, in both an on-line searchable and downloadable database, can be located on the Internet at http://www.hhs.gov/oig. The OIG sanction information is readily available to users in two formats on over 15,000 individuals and entities currently excluded from program participation through action taken by the OIG. The on-line searchable database allows users to obtain information regarding excluded individuals and entities sorted by: (1) The legal bases for exclusions; (2) the types of individuals and entities excluded by the OIG; and (3) the States where excluded individuals reside or entities do business. In addition, the General Services Administration maintains a monthly listing of debarred contractors, "List of Parties Debarred from Federal Programs," at http://www.arnet.gov/epls.

(36) HCFA also offers free online training for general fraud and abuse issues at http://www.hcfa.gov/medlearn. See Appendix F for additional information.

(37) As noted earlier in this guidance, another way for physician practices to receive training is for the physicians and/or the employees of the practice to attend training programs offered by outside entities, such as a hospital, a local medical society or a carrier. This sort of collaborative effort is an excellent way for the practice to meet the desired training objective without having to expend the resources to develop and implement in-house training.

(38) Some publications, such as OIG's Special Fraud Alerts, audit and inspection reports, and Advisory Opinions are readily available from the OIG and can provide a basis for educational courses and programs for physician practice employees. See Appendix F for a partial listing of these documents. See Footnote 3 for information on how to obtain copies of these documents.

(39) Currently, the OIG is monitoring a significant number of corporate integrity agreements that require many of these training elements. The OIG usually requires a minimum of one hour annually for basic training in compliance areas. Additional training may be necessary for specialty fields such as claims development and billing.

(40) Instances of noncompliance must be determined on a case-by-case basis. The existence or amount of a monetary loss to a health care program is not solely determinative of whether the conduct should be investigated and reported to governmental authorities. In fact, there may be instances where there is no readily identifiable monetary loss to a health care provider, but corrective actions are still necessary to protect the integrity of the applicable program and its beneficiaries, e.g., where services required by a plan of care are not provided.

(41) The physician practice may seek advice from its legal counsel to determine the extent of the practice's liability and to plan the appropriate course of action.

(42) The OIG has established a Provider Self-Disclosure Protocol that encourages providers to voluntarily report suspected fraud. The concept of voluntary self-disclosure is premised on a recognition that the Government alone cannot protect the integrity of the Medicare and other Federal health care programs. Health care providers must be willing to police themselves, correct underlying problems, and work with the Government to resolve these matters. The Provider Self-Disclosure Protocol can be located on the OIG's web site at: www.hhs.gov/oig. See Appendix D for further information on the Provider Self-Disclosure Protocol.

(43) In addition to whatever other method of communication is being utilized, the OIG recommends that physician practices post the HHS-OIG Hotline telephone number (1-800-HHS-TIPS) in a prominent area.

(44) See Footnote 35 for information on how to access these lists.

(1) HCFA has recently developed a web site which, when completed by the end of the year 2000, will contain the LMRPs for each of the contractors across the country. The web site can be accessed at http://www.lmrp.net.

(2) The relevant manual provisions are located at MCM, Part III, Secs. 7300 and 7320. This section of the manual also includes the carrier's recommended form of an ABN.

(3) See 42 U.S.C. 1395dd(a).

(4) See 42 U.S.C. 1395dd(b)(1).

(5) See 42 U.S.C. 1395dd(b)(2) and (3).

(6) See 42 U.S.C. 1395dd(c)(1)(A).

(7) Hospitals and physicians, including on-call physicians, who violate the statute may face penalties that include civil fines of up to $50,000 (or not more than $25,000 in the case of a hospital with less than 100 beds) per violation, and physicians may be excluded from participation in the Federal health care programs.

(8) 42 CFR 415.150 through 415.190.

(9) 42 CFR 415.174.

(10) Id.

(11) This section is not intended to be and is not a complete reference for teaching physicians. It is strongly recommended that those physicians who practice in a teaching setting consult their respective hospitals for more guidance.

(12) This concern is noted in Advisory Opinion No. 98-4 and also the Office of Inspector General Compliance Program Guidance for Third-Party Medical Billing Companies. Both are available on the OIG web site at http://www.hhs.gov/oig.

(1) Available through the OIG web site at http://www.hhs.gov/oas/ratstat.html.