Re: Medicare Program; Reporting and Returning of Overpayments, CMS-6037-P, RIN 0938-AQ58, Federal Register, Thursday, February 16, 2012.

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1 Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-6037-P Mail Stop C Security Boulevard Baltimore, MD Re: Medicare Program; Reporting and Returning of Overpayments, CMS-6037-P, RIN 0938-AQ58, Federal Register, Thursday, February 16, Submitted electronically to on The American Dental Association (ADA) is the world s oldest and largest professional dental association with over 160,000 members. The ADA is a national and international leader in the development of consensus standards and guidelines for materials, instruments, equipment, digital devices, and health information technology software impacting the safety and health of the public and the practice of dentistry. The ADA has long standing policy that opposes fraudulent practices in both public and private dental benefit programs and has worked with government agencies, the insurance industry and other organizations to develop effective strategies for the detection and discipline of fraudulent practices. The ADA conducts workshops and other educational outreach efforts to the dental profession on claims practices to promote the highest ethical standards regarding requests for reimbursement under dental benefit programs, as well as full compliance with regulations in connection with claims submission. However, since the proposed rule on reporting and returning overpayments applies equally to simple payment errors in claims submissions and cases of intentional fraud, the ADA is concerned that the application of the False Claims Act liability standard will create unnecessary burdens on providers and may have a chilling effect on participation in Medicare and other public programs. Specifically, the ADA urges CMS to: amend the proposed definition of identify shorten the proposed ten-year look-back period, and refrain from imposing affirmative duties on individuals who suspect kickback arrangements Definition of identify. The ADA urges CMS to use the unambiguous standard definition of identify, and not to add the False Claims Act definition of know and knowingly to the definition of identify in the final rule. Also, the ADA urges CMS to remove the reckless disregard and deliberate

2 Page 2 ignorance categories from Section (a)(2) of the proposed rule. Both of these terms represent ultimate legal conclusions that have no place in defining a workable, understandable designation of a specific period in which to take concrete actions. Section 6402(d) of the Affordable Care Act requires a person who has received a Medicare overpayment to report and return the overpayment within 60 days of the date on which the overpayment was identified (emphasis added), or the date any corresponding cost report is due, if applicable. Failure to return the overpayment before the 61 st day can result in liability under the False Claims Act. Section (a)(2) of the proposed rule states that a person has identified an overpayment if the person has actual knowledge of the existence of the overpayment or acts in reckless disregard or deliberate ignorance of the existence of the overpayment. It does not make sense to impose a timed obligation to report and return overpayments on a person who has no actual knowledge of the overpayment s existence. Moreover, it does not make sense to begin a 60-day period on an uncertain date based on reckless disregard or deliberate ignorance, which is a legal conclusion that would follow an adjudication of the facts, and not an event that a person could designate for purposes of calculating a reporting period. By defining identify in this manner, the proposed rule would impose impossible compliance burdens because persons subject to the rule could not determine when the 60- day period commences and when the report and repayment are due. The requirement is vague and unworkable, and persons subject to the rule will not be able to understand their compliance obligations. In addition, the proposed rule goes beyond the intent of the statute by defining identify to include the False Claims Act s definition of know and knowingly. Section 6402(d)(4)(A) of the Affordable Care Act uses the term the date on which the overpayment was identified, not the date on which the person knew of the overpayment (emphasis added). The statute does not use the terms know or knowingly, to definite identify, and does not reference those terms with respect to the commencement date of the 60 day reporting period. Indeed, it is difficult to imagine how CMS or a Medicare provider or supplier could determine the date on which an overpayment was identified, and thus the date it must be reported and returned, if a provider or supplier is deemed to have identified an overpayment of which it has no actual knowledge. It follows logically, from the proposed rule s definition of identify, that a person who is determined to be in a state of reckless disregard or deliberate ignorance with respect to Medicare claims would be unavailable to take advantage of the 60-day period to return and report overpayments, assuming that such a state existed for more than 60 days. However, CMS provides no guidance as to what a person must do in order to avoid such a determination. The ADA urges CMS to provide clear guidance as to precisely what actions a provider or supplier must take to avoid a determination that it is in reckless disregard or deliberate ignorance of the existence of an overpayment.

3 Page 3 In the preamble, CMS states that if a person receives information that creates an obligation to make a reasonable inquiry to determine whether an overpayment exists, and if the reasonable inquiry reveals an overpayment, the person then has 60 days to report and return the overpayment. This implies that the overpayment is identified when the person has actual knowledge. CMS goes on to state that if a person in this situation fails to conduct an inquiry with all deliberate speed after obtaining such information, the person may be knowingly retaining an overpayment because the person may have acted in reckless disregard or deliberate ignorance. CMS gives examples of information that would require a person to make a reasonable inquiry, such as a hotline complaint and a billing or payment records review that reveals incorrect coding. However, the proposed rule does not provide sufficient guidance for persons to determine when they are obligated to make a reasonable inquiry, and how to determine whether they are proceeding with sufficient speed. The ADA urges CMS to provide in the final rule that a person making a good faith effort to investigate a suspected overpayment may report and return any actual overpayment within 60 days of its actual discovery. The ADA further urges CMS to provide clear guidance as to what constitutes the reasonable inquiry that a provider or supplier must make when it suspects, but does not have actual knowledge, that an overpayment exists, including guidance as to the adequate nature, scope, and timing of the inquiry. The ADA further urges CMS to provide guidance as to whether a person conducting an inquiry that reveals more than one overpayment is required to return each overpayment as it is identified, or whether a person may complete the investigation and return the total of all related overpayments at the end of the investigation. Ten-year look back period. Section 6402(d) of the Affordable Care Act does not establish a look-back period for reporting and returning overpayments, nor does the statute change the statute of limitations in the False Claims Act or the timeframes in existing Medicare reopening regulations or in regulations regarding liability for overpayments. The intent of the statute thus appears to be to rely on these existing time periods. Section (g) of the proposed rule goes far beyond the statutory requirement by establishing an extraordinary ten-year look-back period for any kind of overpayment, including overpayments that are due to payor mistakes and overpayments resulting from routine errors. A ten-year look-back period would impose a highly unreasonable burden on Medicare providers and suppliers. Decade-old information could trigger an obligation to conduct a reasonable inquiry into records from years far in the past, and even more recent information could require persons to conduct a burdensome inquiry into voluminous records spanning a decade. Extending the look-back period to ten years may make it impossible for a provider or supplier to complete an investigation and return and report any overpayment within the 60 day period, particularly if an overpayment is considered to have been identified as of the day on which a provider or supplier acts in deliberate ignorance or with reckless disregard as to its existence.

4 Page 4 The ADA urges CMS not to establish a look-back period, but rather to rely on the existing three-year statutory and regulatory timeframe for the RAC program (see In a 2010 report to Congress, CMS stated: In accordance with Section 306 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), a Recovery Audit demonstration was conducted from March 2005 to March 2008, in six states, to determine if Recovery Auditors could effectively be used to identify improper payments for claims paid under Medicare Part A and Part B. The RAC demonstration was an important tool in helping CMS prepare for and shape the RAC permanent program. This preparation led to the incorporation of several important components of the RAC permanent program, including building cooperative relationships with Medicare claims processing contractors, fraud fighters, the Department of Justice, and appeals entities; contracting with a RAC validation contractor to conduct independent thirdparty reviews of RAC claim determinations; limiting the claim review look-back period to three years; requiring each RAC to hire a medical director; and conducting significant outreach to providers. Due to the success of the Recovery Audit demonstration, the U.S Congress passed the Tax Relief and Health Care Act of 2006, which authorized the expansion of the Recovery Audit program nationwide by January The ADA believes that the three-year look-back has solid legislative backing from both the 2003 and 2006 acts that created the RAC. There is no rational basis for using a different look-back period for the obligation to report and return Medicare overpayments. The shorter regulatory look-back period proposed by the ADA would not affect the longer statute of limitations pertaining to criminal conduct and so the public interest would not be compromised. Anti-Kickback Statute The preamble to the proposed rule addresses Medicare overpayments that arise due to a violation of the anti-kickback statute, noting that compliance with the anti-kickback statute is a condition of payment. The preamble notes that a person submitting a claim that is subject to a kickback arrangement between third parties is not required to report the overpayment as long as the person is unaware of the existence of the kickback arrangement. CMS notes that a person who becomes aware of a potential arrangement would generally not be able to evaluate whether the payment was an illegal kickback or whether one or both of the third parties had the requisite intent to violate the anti-kickback statute. Nevertheless, CMS states that if a person submitting a claim has sufficient knowledge of the arrangement to have identified the resulting overpayment, the person must report the overpayment. Thus, a nonparty to a suspected kickback arrangement may be required to report the suspicion or risk False Claims Act liability, although CMS states that only the parties to the kickback arrangement would be required to repay the overpayment that was received by the innocent provider or supplier, except in the most extraordinary circumstances.

5 Page 5 The ADA urges CMS not to impose an affirmative duty to report a suspicion. An individual who is not a party to a kickback arrangement would be unable to determine: whether he or she has sufficient knowledge of the arrangement to be deemed to have identified a resulting overpayment, and when he or she would be required to repay a Medicare payment that is deemed an overpayment due to a kickback arrangement to which he or she was not a party. Thank you for the opportunity to comment on the Medicare Program; Reporting and Returning of Overpayments Proposed Rule, CMS-6037-P. If there are questions concerning these comments, please contact Dr. Frank Kyle in the ADA Washington, D.C. Government and Public Affairs Office at or by at kylef@ada.org. Sincerely, William R. Calnon, D.D.S. President Kathleen T. O Loughlin, D.M.D., M.P.H. Executive Director WRC:KTO:fak