of the Act Determination - Refunds to Beneficiary

14.3 - Section 1842(l) of the Act Determination - Refunds to Beneficiary (Rev. 3, 11-22-00) For §1862(a)(1) of the Act denials on non-assigned claims involving physician or supplier services, carriers must make a determination under §1842(l) regarding whether the physician or supplier must refund any payment collected from the beneficiary. This should be done for initial determinations (prepay) and for postpayment denials. Carriers make a §1842(l) physician or supplier refund determination if the reviewer concludes that the services were not reasonable and necessary. For physician or supplier claims where assignment was not taken, a §1842(l) refund determination must be made. Carriers must make a determination for each claim that is denied as not reasonable and necessary. A physician or supplier cannot be considered overpaid if payment was not made to the physician for the claim. A physician or supplier who takes assignment on a claim-by-claim basis may be audited and the sample may include some non-assigned claims. Consideration of a refund on the non-assigned claims denied based on §1862(a)(1)(A) of the Act is appropriate, but a finding that a refund is appropriate does not create a Medicare overpayment. A. Documentation of §1842(l) of the Act Determination The carrier must document the basis for the determination (i.e., rationale), including appropriate references to contractor newsletters, prior denials, sponsored meetings attended by the provider, etc., where applicable. Any correspondence going to the beneficiary or physician, or supplier (i.e., demand letters) should include all §1842(l) refund determinations. Document §1842(l) determinations in the CMR summary report. B. Section 1842(l) of the Act Determination With Respect to Overpayments A physician refund obligation under §1842(l) is not a determination of a program overpayment. If the refund obligation arises in connection with a postpayment denial, any overpayment would be a beneficiary overpayment. Exhibit 14.4 - Effect of Sections 1879 and 1870 of the Social Security Act During Postpayment Reviews (Rev. 17, 12-12-01) The Medicare law contains two provisions that affect the determination and the recovery of overpayments. One is §1879 of the Act, which deals with limitation on liability for services determined to be noncovered because they are, for example, custodial or are not reasonable and necessary under Medicare law, or, for home health services, the patient is not confined to home or the skilled nursing services are not intermittent. If the denial involves items or services to which the provisions of §1879 (limitation on liability) apply, MR makes a determination in accordance with instructions in MIM §3431, MCM §7300and CMS Ruling 95-1. The other law affecting the determination and the recovery of overpayments is §1870 of the Act, which provides a framework within which liability for overpayments is determined and recovery of overpayments is pursued. If the denial of a claim involves items or services to which the provisions of §1879 (limitation on liability) do not apply, or if an overpayment results from a §1879 determination that either the beneficiary or the provider is liable, contractors make a determination as to whether the provider was without fault for the overpayment under the provisions of §1870 in accordance with MIM §3431and MCM §7300. Exhibit 15 - Consent Settlement Documents - (Rev. 3, 11-22-00) (Rev. 96, Issued: 01-14-05, Effective: 02-14-05, Implementation: 02-14-05) The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 requires several letters to be sent to providers or suppliers regarding consent settlement. Contractors shall send to the provider or supplier a request for additional information letter, a consent settlement offer letter, and a no action letter if an overpayment was not found or if an overpayment was found, a letter requesting the moneys owed. A. First Letter in the Consent Settlement Process: Opportunity to Submit Additional Information Before Consent Settlement Offer Notification Before a consent settlement is offered, contractors must communicate in writing to the provider or supplier that they have the opportunity to submit additional information. This document shall: • Explain there may be an overpayment due to an initial evaluation of the records; • Highlight the nature of the problems in the provider’s or supplier’s billing and practice patterns identified as a result of the preliminary audit; • Give steps the provider or supplier can take to address the problems; and • Identify the forty-five (45) day time frame to furnish this additional information. List the following information in the heading of the letter: • Date of notice; • Name of provider; • Address; and • City, state, and zip code. Italics within parentheses indicate insertions and must not be inserted in correspondence going to providers. Under Section 1842 of the Social Security Act, carriers under contract to the Centers for Medicare & Medicaid Services are authorized to "make audits of the records of providers of services as may be necessary to assure that proper payments are made under this part." We are responsible for conducting audits of providers to ensure that Medicare Part B claims have been billed and paid appropriately. Based on our preliminary evaluation of your medical records on__________,_ (Fill in date) we have found an indication of a potential overpayment. The purpose of this letter is to describe the nature of the problems identified in our evaluation, the steps that you should take to address these problems, and give you the time frame to furnish additional information concerning the medical records for the claims being reviewed. During our initial evaluation, we have ascertained the following issues, (List the problems found.) To resolve these issues and to determine that there is an overpayment, the following are the steps you may take: (List action that can be taken to resolve the problems.) You have forty-five (45) days from the receipt of this letter, ____to submit any additional information concerning the medical records for the claims being reviewed in this evaluation. Send this information to _________. If you have any questions, please contact me at______. B. Second Letter in the Consent Settlement Process: Consent Settlement Offer Consent settlement documents must closely conform to the content of the model language provided below. The consent settlement documents shall explain: • The responsibility of CMS in conducting audits of providers or suppliers to ensure that Medicare Part B claims have been billed and paid appropriately; • The date of the initial request for records prior to conducting the audit; • The steps involved in the audit process; • The problems in the provider’s or supplier’s billing and practice patterns identified as a result of the audit; • To notify the provider or supplier of the potential overpayment calculated as a result of the audit; and • Two options available to the provider or supplier. NOTE: The Consent Settlement Documents shall include information regarding statistical sampling for overpayment estimation. Refer to §3.10 of the Program Integrity Manual (PIM) for instructions for the use of statistical sampling for overpayment estimation. List the following information in the heading of the letter: • Date of notice; • Name of provider; • Address; and • City, state, and zip code. Italics within parentheses indicate insertions and must not be inserted in correspondence going to providers. Under Section 1842(a)(1)(C) of the Social Security Act, carriers under contract to the Centers for Medicare & Medicaid Services are authorized to "make audits of the records of providers of services as may be necessary to assure that proper payments are made under this part." We are responsible for conducting audits of providers to ensure that Medicare Part B claims have been billed and paid appropriately. On __________________, [Fill-in date of initial request for records prior to conducting audit.] you received a notification letter stating that you had the opportunity to submit additional information to us after our preliminary evaluation of your records indicated a potential overpayment. On __________________, [Fill-in date of initial request for records prior to conducting audit.] you also received our request for records to conduct an audit of your practice. The purpose of this letter and attachments is to describe the steps involved in the audit process, to highlight problems in your billing and practice patterns identified as a result of our audit, to notify you of the potential overpayment calculated as a result of our audit, and to outline two options available to you. Our normal full-scale audit process entails the review of records using statistical sampling for overpayment estimation. However, in the interest of economy and expediency for both you and the Medicare program, as a first step, we elected to perform a limited audit. We reviewed claims and medical records for services rendered to beneficiaries over a period of time, from____________to____________. While__________beneficiaries were randomly selected for our sample from a larger universe of beneficiaries for whom you provided services, it is not done based on our instructions for conducting statistical sampling for overpayment estimation. You were chosen for an audit because______________________ [Fill-in the reason for the audit. The reason may be exceeding peer norms or a call from a beneficiary. For example, if the provider exceeded peer norms the contractor might want to use the following language: "You were chosen for an audit because our records indicate you exceeded the average utilization rates of your peers by______% for the same time period. Your specialty is listed as__________________. The peer group consisted of__________ who billed for the same procedure(s)."] We selected the ____________ beneficiaries by identifying the procedure codes where your billing exceeded the norm for your peers. Included in the universe are only those beneficiaries for whom you rendered and billed at least one of these procedure codes that was paid by Medicare during the review period. From this universe of beneficiaries, a computer is used to randomly select the beneficiaries to be included in the sample. All claims for the procedure codes at issue that were rendered to the sampled beneficiaries and paid within the time period were audited. [This sentence may be modified depending upon whether the audit used the date of service or the date of payment for selecting claims. As it is stated, all claims would have to actually been paid within the time period. Whichever method is used, you must be consistent.] The list of sampled beneficiaries, dates of service, and procedure codes is contained in the attachment to this letter. The beneficiaries included in our audit resulted in claims being paid by Medicare between____________________. [See note in preceding paragraph. Similar rewording may be required here.] These claims and their corresponding medical records were audited, resulting in a potential overpayment of $__________including an actual overpayment of $___________for the________ beneficiaries. Item 3 under "Audit Results" explains how we calculated the potential overpayment. Please review the attached documents containing the audit results and options along with an explanation of the Extended Repayment Plan. We must have your response to this letter within sixty (60) days from the date of this letter,____________ If we do not receive a response from you by_______________ , statistical sampling for overpayment estimation will be chosen for you by default (see attached discussion of audit results). Be advised that by signing this letter your legal options may be affected. Please also be advised that repayment of the overpayment specified herein in no way affects or limits the rights of the Federal Government or any of its agencies or agents to pursue any appropriate criminal, civil, or administrative remedies arising from or relating to these or any other claims. You may wish to have legal counsel review this letter before signing it. If you have any questions, please contact me – at______________________________. Sincerely, Attachments C. Consent Settlement Attachment 1 Audit Results IDENTIFYING INFORMATION List the following information in the heading of the attachment: • Date; • Provider Name; • Provider Address; and • Provider Number. SCOPE OF AUDIT This audit covers services that were paid by Medicare from____________________to____________________. [Modify this sentence depending upon whether the audit used the date of service or the date of payment for selecting claims. As it is currently stated, all claims would have to have been acutally paid within the time period. Whichever method is used, you must be consistent.] The audit revealed the following problems in your billing and practice patterns: ISSUES/DETERMINATIONS A physician reviewer, specializing in __________________________ [You are required to have a medical specialist involved in the review of the sample claims that are not based on application of clearly articulated existing MR policy. Fill-in the specialty here.] was consulted during the audit process. The following claims and submitted records of determinations were used in the review. [This area lists the problem areas noted above, such as exceeding peer norms and medical necessity/documentation concerns. Additionally, each of the sampled beneficiaries, dates of services, procedure codes, and the Medical Director's determination on each denied service is noted here. Attach newsletters discussing medical policy and documentation requirements for the problem areas found during the audit.] [This is also the area where you explain the §1879 and §1870 determinations, perhaps using, in part, the following language: For §1879: "Based on available information, we believe you knew or should have known that..." For§1870: "We have made the determination that you were not "without fault" in causing the overpayment. Therefore, we are not waiving your obligation to repay. We cannot find you without fault because..." Rationale for the §1879 and/or §1870 findings might include all or part of the following language:] "The management of a medical or supplier practice that includes a large number of Medicare beneficiaries must understand the conditions governing which services will be covered and payable under Part B of the Medicare Program. Pertinent information was available from the law and regulations [provide a cite, if possible], from [cite name/issue number of carrier newsletter], from a meeting you attended on date, and from your peers in the medical community ." Carriers need to make specific findings for §1879 and §1870. The rationale for finding provider knowledge or fault with regard to a particular claim may not be the same as for another claim. This may be so even for multiple denials for a particular code since MN is a unique and individualized determination. These individual findings are especially important if #167;1879 and/or §1870 determinations are partially favorable. In such cases, specify which of the sample claims are affected, why, and how much this reduces the actual and total potential overpayment amounts (see §1879) or reduces the amount of the actual and total potential overpayments which must be refunded (see §1870). Because §1879 and 1870 determinations are difficult concepts, it is important to explain to physicians exactly why they are being held responsible under these provisions. Your explanation must go beyond conclusory statements and/or findings.] CALCULATIONS A copy of our calculation worksheet is enclosed for your information. To calculate the potential projected overpayment amount for each denied procedure code, the following formula was used: [In this section, insert a complete explanation of the methodology used to calculate the overpayment and the projected overpayment for each denied procedure code. The explanation must include the formula used when the audited services were down coded rather than denied and when only one example of a procedure code was audited.] Procedure Co de Denied Services #Sam ple Denied Services #Univer se Down-coded Services #Samp le Down- coded Services #Univers e Potential Overpayme nt [This table lists procedure codes, the number of services in the sample and in the universe that were denied or down-coded, and the resulting potential overpayment amount.] The actual overpayment amount is $_______________. The sum of all potential projected procedure code overpayments, including the actual overpayment amount, is $_______________. OPTIONS You must now select one of the two options explained below. Our normal audit process entails the routine use of Option One. However, we are now making another option available to you as a consent settlement. If you fail to notify us of your selected option, Option One (Election to Proceed to Statistical Sampling for Overpayment Estimation) will automatically be selected for you by default. Be aware that when statistical sampling for overpayment estimation is selected for audit, records for all of the services at issue must be available for review. Please send in your response to the options listed below within sixty (60) days from the date of this letter,_______________ . Regardless of the option selected, beneficiaries may not be billed for any of the overpayment amount. Option One Election to Proceed to Statistical Sampling for Overpayment Estimation If we do not hear from you within sixty (60) days from the date of this letter, _______________, we will proceed with Option One by default. [This is the second step in the audit process if you have been offered a consent settlement on a potential overpayment but do not accept the offer.] This step utilizes statistical sampling for overpayment estimation for the same universe or time period. Your right to appeal to a Hearing Officer, an administrative law judge or to the court remains if you should choose this option. Also, any rights available to you under §1870 and/or 1879 of the Social Security Act remain. Be aware that this option, either by your selection or by default, means that you are required to submit medical documentation for all of the services at issue in the statistical sampling for overpayment estimation [(just as you would have had to do if we had not first offered you the opportunity for a consent settlement on a potential overpayment).] You should also be aware that this option, whether selected by you or by default, withdraws the option of a consent settlement, as described in Option Two. If you elect (or accept by default) Option One, it is important that you understand the following information concerning our actions and your responsibilities with regard to the actual overpayments found for the claims involved in the limited audit: The potential projected overpayment referred to in this correspondence is based on a sample of _______________ beneficiaries. We audited claims and medical documentation for the_______________ beneficiaries in the sample to arrive at an actual overpayment for these claims. The actual overpayment amount was then projected to the universe of procedure codes to develop the potential projected overpayment. (See above for the actual overpayment amount and the potential projected overpayment amount.) Option Two involves repayment of the potential projected overpayment, which includes the actual overpayment amount. Choosing Option One does not eliminate your obligation to repay the actual overpayment. Recoupment of the actual overpayment identified for the claims in the limited audit will be pursued individually, but their recovery will be credited against any projected overpayment for the universe to which the claims belong. Your obligation to repay the overpayment for these claims will begin on the date of the official notification of overpayment. You will be notified of your appeal rights on these claims at this same time. Option Two Acceptance of Consent Settlement Offer You agree to repay the potential projected overpayment, after providing additional medical documentation relevant to the____ beneficiaries involved in our sample which was in existence at the time the services were rendered. Review of this information will result in one of three decisions: • All services in contention could be determined to be appropriate and allowed as originally processed, and the question of any potential overpayment would be eliminated; or • A portion of the services in question could be determined to be appropriate and allowed as originally processed, and the amount of the potential overpayment would decrease accordingly; or • The audit results could remain the same and the potential projected overpayment would remain at $_______________. You may request a meeting to explain the additional documentation or to provide other information relevant to the redetermination. If you select Option Two, you agree to refund the revised potential overpayment amount, if any, which will not exceed the dollar amount calculated in Item 3 of this attachment and printed above. The revised potential overpayment amount will not exceed the capped amount. By selecting this option, regarding repayment, you agree that there was a problem in your billing as identified by the carrier, you intend to correct this problem in future billings, and you understand how we reached the potential overpayment, i.e., you understand the sampling methodology used and the methodology to project the potential overpayment. Because you agree that there was a problem and agree to make changes in your practice to resolve this problem, you waive your right to appeal the sampled individual overpayments, the potential overpayment resulting from the projection and the sampling procedures. The appeal rights you are waiving include a hearing before a Hearing Officer, Administrative Law Judge, or in the Courts. You also waive any rights you have under §1870 and/or 1879 of the Social Security Act. (Please see Items 6 and 7 in this attachment for a discussion of these rights.) Election of Option Two means that, in the absence of potential fraud, we will not audit your claims for any procedure codes projected in our audit during the audit time frame again. In the event of fraud and/or if you fail to correct the identified problems, we reserve the right to audit prior years' claims and claims for any procedure codes for the time period considered in this audit. ASSESSMENT OF INTEREST We wish to make you aware, should you elect Option Two, that interest will be assessed on any balance outstanding thirty (30) days from the date of the letter notifying you of a final potential overpayment, if any. Should you choose Option One, interest will be assessed on any balance outstanding thirty (30) days from the date of the letter notifying you of a final overpayment determination. We must assess interest as provided in 42 CFR §405.376. Interest will accrue on the unpaid balance for each thirty (30) day period (or portion thereof) that repayment is delayed. The current interest rate is _______________ %. LIMITATION OF LIABILITY Section 1879 of the Social Security Act (42 USC §1395pp, 42 CFR §411.406) permits Medicare payment to be made to providers on assigned claims for certain services otherwise not covered because they were not reasonable or necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, or were custodial services if neither the beneficiary nor the provider knew, or could reasonably be expected to know, that the services were not medically necessary or were for custodial care. Services affected are those disallowed as not reasonable or necessary for the diagnosis or treatment of illness or injury, or to improve the functioning of a malformed body member and those disallowed as custodial services. WAIVER OF OBLIGATION TO REPAY UNDER §1870 OF THE SOCIAL SECURITY ACT Section 1870 of the Social Security Act (42 USC §1395gg, 42 CFR §405.704(b)(14)) permits you to request waiver of an overpayment on the grounds that you were "without fault" with respect to causing the overpayment. This determination is made after §1879 is considered. If it is determined that you or the beneficiary knew or should have known that the service was not medically necessary and reasonable or constituted custodial care as described under the provisions of §1879, we address §1870 and determine whether you were "without fault" with respect to causing the overpayment. GENERAL We wish to ensure that you are aware of regulations and provisions of the law relating to continuation of the problems discussed herein. They include exclusion from the Medicare Program in accordance with §1128(b) of the Social Security Act (42 USC §1320a-7), civil monetary penalties or other actions in accordance with §1128A of the Social Security Act (42 USC 1320a-7a), and/or, if appropriate, withholding payment under 42 CFR 405.370. Your decision regarding this matter must be in writing and received by this office within sixty (60) days from the date of this letter. If your decision is not received by the above-mentioned date, Option One, Election to Proceed to statistical sampling for overpayment estimation, will be selected for you by default. We have enclosed two copies each of the two option forms for your convenience. Select one of the options, complete and sign both forms corresponding to that option, and send them to my personal attention at the address shown below. The provider must personally sign the forms. A signature stamp, or the signature of a staff member or attorney is not acceptable. After receipt of the two identical option forms with authorized signatures, we will sign both forms and return one to you. Name: Title: Address: Telephone number: D. Consent Settlement Attachment 2: Option One - Election To Proceed To Statistical Sampling For Overpament Estimation Option One - Election to Proceed to Statistical Sampling for Overpayment Estimation I,______________________________: • have read the results of the audit findings in the letter dated _____________. • elect to proceed to your full-scale audit process, involving use of statistical sampling for overpayment estimation for the same universe of procedure codes and time period as the limited audit, as explained in the letter. I understand the full-scale audit process is the normal audit process, and that the limited audit was offered to me only in the interest of economy and expediency. Upon selection of Option One, I understand that the offer of a consent settlement as stated in Option Two is withdrawn. • understand that I and/or my office staff will be required to submit medical documentation for all services at issue in the statistical sampling for overpayment estimation, upon request by the carrier. • understand that all applicable appeals rights, including any right to a hearing officer hearing, an administrative law judge hearing, or court review are available to me. I also retain any rights available under §1879 and/or 1870 of the Social Security Act, as appropriate. • understand that the claims from the above-referenced limited audit will not be selected for inclusion in the statistical sampling for overpayment estimation; the statistical sampling for overpayment estimation will be a new and independent audit. • understand that the overpayment identified for claims in the limited audit will be pursued on an individual basis, and that this overpayment will be subtracted from any overpayment resulting from the statistical sampling for overpayment estimation; that I will be provided with appeal rights regarding the overpayment amount on the claims in the limited audit at a later date; and that any interest on the overpayment amount on the claims in the limited audit will be calculated from the date of this later notice with appeal rights. • understand that the rights of the Federal Government or any of its agencies or agents to pursue any appropriate criminal, civil, or administrative remedies arising from or relating to these or any other claims are in no way affected or limited by selection of this option. Provider signature: _________________________ Date signed: ______________________________ Printed or typed name: ______________________ Title of signatory: __________________________ Carrier Representative Signature: ______________ Date signed: _____________________________ Printed or typed name: _______________________ Title of signatory: ___________________________ Please submit both copies of the selected option form, with original signatures, in the enclosed envelope. Upon completion, a file copy will be returned to you. E. Consent Settlement Attachment 3 Option Two - Acceptance of Consent Settlement Offer I,_____________________________: • have read the results of the audit findings in the letter dated_______________. • understand the issues the carrier presented and the calculation of the projected potential overpayment and agree to settle the issue of a potential projected overpayment by refunding a redetermined amount of up to $_________________to Medicare. This amount was derived by reviewing a sample of my claims and determining that a potential overpayment did exist within the universe of my claims. • have enclosed additional documentation for you to review for the purpose of redetermining the potential overpayment. I understand that I may request a meeting to explain the additional documentation or to provide other information relevant to the redetermination. I understand the redetermined potential overpayment, if any, will not exceed the amount shown above. • understand that if the redetermined settlement amount is not refunded to Medicare within thirty (30) days from the date of the redetermined potential overpayment notice, the unpaid balance is subject to offset. I may apply for an extended repayment plan and, if approved, may make payments over an approved period of time. • understand that interest on the amount accrues from the date of the final potential overpayment determination, but that this interest will be waived if repayment is made within thirty (30) days from the date of the final potential overpayment determination. • understand that claims paid to me from ______________ to_______________will not be audited in the future. [Reword this statement to reflect services dates if service dates were used in the audit to select claims instead of dates of payment.] I further understand that in the event of fraud or if I fail to correct the identified problems, the carrier reserves the right to audit prior years' claims and claims for any procedure codes for the time period considered in this audit. • understand that the rights of the Federal Government or any of its agencies or agents to pursue any appropriate criminal, civil, or administrative remedies arising from or relating to these or any other claims are in no way affected or limited by selection of this option. I,___________________________, agree by settling this: • that my right to appeal, which includes a Medicare Part B hearing officer hearing, administrative law judge hearing, or any court appeals regarding this matter, is waived. I also understand any rights available to me under §1879 and/or 1870 of the Social Security Act are waived. I,____________________________, do/do not (circle one) wish to request a meeting at this time to discuss the additional documentation I have submitted. Provider signature:_______________________ Date signed:____________________________ Printed or typed name:____________________ Title of signatory:________________________ Carrier Representative Signature:____________ Date signed:_________ Printed or typed name:____________________ Title of signatory:_________________________ Please submit both copies of the selected option form, with original signatures, in the enclosed envelope. Upon completion, a file copy will be returned to you. F. Consent Settlement Attachment 4: Extended Repayment Plan (ERP) It has been determined by an audit that there is a potential overpayment amount due to Medicare. It is expected that you will remit the entire amount in one payment within thirty (30) days of the date of the final potential overpayment determination if you select Consent Agreement Option Two (Acceptance of Consent Settlement Offer), or, if you select Option One (Election to Proceed to Statistical Sampling for Overpayment Estimation), the date of the final overpayment determination. However, if you are unable to repay the amount within that time, we are authorized to consider repayment in installments based on validated financial hardship. [Installments are based on the amount of the overpayment as stated in Financial Management, Chapter 4, §§20, 30.] Installments can range from 2-6 months based on the amount of overpayment. Be aware that if repayment is not made within thirty (30) days, interest will be due. If you select Consent Agreement Option Two, interest accrues from the date of the final potential overpayment determination, or if you elect Option One, interest accrues from the date of the final overpayment determination (See 42 CFR 405.378.). Interest will be waived if repayment is made within thirty (30) days of the applicable date cited above for the option chosen. The current rate of interest is _______ percent. If you wish to claim financial hardship, contact _______________________ to obtain the financial statement of debtor form (CMS-379). This form must be completed and returned with your request for approval of an installment schedule. If compliance with the above is not acceptable to you, it is suggested that you seek a private or commercial loan to satisfy the obligation. If repayment of the amount due, in a lump sum or on an approved installment plan, is not forthcoming, the Centers for Medicare & Medicaid Services may, at its option; forward the case to the Department of Justice or the Internal Revenue Service (IRS) for enforced collection. G (1). Third Letter in the Consent Settlement Process: No Action if an Overpayment Was Not Established List the following information in the heading of the letter: • Date of notice; • Name of provider; • Address; and • City, state, and zip code. Italics within parentheses indicate insertions and must not be inserted in correspondence going to providers. You have already received correspondence regarding a potential consent settlement. Thank you for your cooperation in this process. Based on our evaluation of your medical records on__________,_ (Fill in date) we have not found an indication of an overpayment. No additional action on your part, is deemed necessary. If you have any questions, please contact me at______. Sincerely, G (2). Third Letter in the Consent Settlement Process: Request for Money Owed if Overpayment was Established List the following information in the heading of the letter: • Date of notice; • Name of provider; • Address; and • City, state, and zip code. Italics within parentheses indicate insertions and must not be inserted in correspondence going to providers. You have already received correspondence regarding a potential consent settlement. Thank you for your cooperation in this process. Based on our evaluation of your medical records on__________,_ (Fill in date) we have found an indication of an overpayment and the option of a (state if provider elected the statistical sampling for overpayment estimation or accepted the consent settlement offer) was selected. You owe ___(state the amount of money owed). If you have any questions, please contact me at______________________________. Sincerely, Exhibit 16 - Model Payment Suspension Letters (Rev. 13879; Issued: 07-23-26; Effective: 08-24-26; Implementation: 08-24-26) A. Payment Suspension Initial Notice of Suspension Based on Fraud [UPIC Information Header] Confidentiality Notice: This message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender and destroy all copies of the original message. To: [Provider Name] Attn: [Point of Contact] [Provider Street Address] [Provider City, State Zip code] From: [UPIC Name - UPIC Region] [Street Address] [City, State, Zip Code] The remainder of this page is intentionally blank. Delivery Method: [INSERT] [Date] To: [Provider Name] Attn: [Point of Contact] [Provider Street Address] [Provider City, State Zip Code] Reference Number: [INSERT HERE] Provider Name: [INSERT HERE] Provider NPI: [INSERT HERE] Provider PTAN: [INSERT HERE] Subject: Notice of Suspension of Medicare Payments Dear [Point of Contact]: [Use the following template to construct a Notice of Suspension (NOS) for a credible allegation of fraud payment suspension. All NOS shall retain the formatting established in this template. The body of the NOS shall be formatted to “justified” text alignment.] The purpose of this letter is to notify you that the Centers for Medicare & Medicaid Services (CMS), after consulting with the Department of Health and Human Services Office of Inspector General, has decided to [SELECT FULL OR PARTIAL SUSPENSION LANGUAGE: fully suspend Medicare payments to Click here to enter Provider/Supplier Name, (Click here to enter abbreviated Provider/Supplier Name), pursuant to 42 C.F.R. § 405.371(a)(2) and 42 C.F.R. § 405.372(a)(4). OR partially suspend Medicare payments to Click here to enter abbreviated Provider/Supplier Name at a rate of [X]%, pursuant to 42 C.F.R. § 405.371(a)(2) and 42 C.F.R. § 405.372(a)(4).] [SELECT NO PRIOR NOTICE OR PRIOR NOTICE LANGUAGE: The suspension of Medicare payments took effect on [Month Day, Year]. Prior notice of this suspension was not provided because giving prior notice would place additional Medicare funds at risk and hinder CMS’ ability to recover any determined overpayment. See 42 C.F.R. §§ 405.372(a)(3). OR The suspension of Medicare payments will take effect on [Month Day, Year].] The decision to suspend Medicare payments is based on credible allegations of fraud. CMS regulations define credible allegations of fraud as allegations from any source including, but not limited to, fraud hotline complaints verified by further evidence, claims data mining, and patterns identified through audits, civil false claims cases, and law enforcement investigations. 42 C.F.R. § 405.370(a). Allegations are considered to be credible when they have indicia of reliability. Id. This suspension will last until resolution of the ongoing investigation, as defined under 42 C.F.R. § 405.370(a).1 Allegation(s) 1 The Office of Inspector General, and the Department of Justice as appropriate, are consulted in all cases of suspected fraud as required by 42 C.F.R. § 405.371(a)(2). The suspension of Medicare payments to Click here to enter abbreviated Provider/Supplier Name is based on, but not limited to, information that Click here to enter abbreviated Provider/Supplier Name misrepresented services billed to the Medicare program. Specifically, the suspension of Medicare payments is based on the following allegation(s) as well as the example claims below, which we have included to provide evidence of the findings. Allegation # (Rename this “Allegation 1” if there is more than one allegation.): [Refer to Attachment A – Notice of Suspension Language Guide, Step 1 to identify and insert the approved language reflective of the primary allegation. Insert the appropriate approved language HERE.] 1. [See Attachment A, Step 2 to identify and insert the approved language reflective of the subparagraph detail associated with the primary allegation.] [Insert claim examples relevant to the subparagraph detail. Add rows if necessary. If one claim box is used for multiple subparagraph details of an allegation, the below statement should be inserted after the last subparagraph detail, before the claim box: “The below claim control numbers (CCNs) are examples of the allegations listed above.”] Claim Control Number (CCN) Date(s) of Service MM/DD/YYYY 2. [If necessary, add additional subparagraph detail associated with the primary allegation. Use Attachment A, Step 2 to identify the approved language reflective of the necessary subparagraph detail.] [If additional subparagraph detail is added above, insert claim examples relevant to the subparagraph detail. Add rows if necessary.] CCN Date(s) of Service MM/DD/YYYY Allegation 2: (If another primary allegation needs to be added, repeat all steps listed above. Continue repeating these steps to add allegations (e.g., Allegation 2, Allegation 3, etc.) as necessary. If a secondary allegation is identified, use Attachment A, Step 3 to insert the applicable approved language. If no additional allegations are needed after the primary allegation, delete this section and move on.) Investigation Process The investigation into this matter is ongoing, and the claims listed above represent only a sample of the problematic claims identified. The summary of allegations and the claims listed above provide notice of the reasons for the payment suspension. As the investigation continues, you may be asked to provide information. Click here to enter abbreviated Provider/Supplier Name must be responsive to requests for documentation and information to prevent claim denials and other administrative actions. Right to Rebut Pursuant to 42 C.F.R. § 405.372(b), you have the right to submit a written rebuttal statement, including evidence supporting your rebuttal statement. Evidence provided in your rebuttal should be specific to each allegation on which the suspension was based, including but not limited to the claim examples provided.2 Merely providing general assertions or denials typically will be insufficient to overcome the allegation(s). Your rebuttal statement should be received within 15 business days of receipt of this notice. Requests for additional time to submit a rebuttal statement will be considered on a case-by-case basis. If you choose to submit a rebuttal statement, your rebuttal statement should be sent to: [UPIC Region] Unified Program Integrity Contractor [Street Address] [City, State, Zip Code] Notice of Rebuttal Response The suspension of Medicare payments will continue while your rebuttal statement is being reviewed. See 42 C.F.R. § 405.375(a). You will be notified in writing of the response. The response notice will include the findings regarding each allegation or condition upon which the suspension is based and an explanation as to why the suspension of Medicare payments will continue or be terminated. See 42 C.F.R. § 405.375(b)(2). The response following your rebuttal is not an initial determination and is not appealable. See 42 C.F.R. § 405.375(c). Disposition of Suspended Funds The suspension of Medicare payments is based upon credible allegations of fraud, and, as such, a determination will be made regarding an overpayment. A final decision regarding any overpayment may be delayed until the resolution of the investigation. See 42 C.F.R. § 405.372(c)(2). An investigation is resolved when “legal action is terminated by settlement, judgment, or dismissal, or when the case is closed or dropped because of insufficient evidence to support the allegations of fraud.” 42 C.F.R. § 405.370. If an overpayment is determined, you will receive a separate written notice from the Medicare Administrative Contractor that processes the Medicare claims you submit, Click here to enter Name of MAC, advising you of the reasons for the overpayment determination. 42 C.F.R. § 405.921(b). When the payment suspension has been removed, any money withheld as a result of the payment suspension shall be applied first to reduce or eliminate any overpayment, including any interest assessed under 42 C.F.R. § 405.378, and then to reduce any other obligation to CMS or to the U.S. Department of Health and Human Services in accordance with 42 C.F.R. § 405.372(e). In the absence of a legal requirement that the balance be paid to another entity, the excess will be released to Click here to enter abbreviated Provider/Supplier Name. Processing of Claims During the Suspension 2 References in this letter to “rebuttal statement” include references to “evidence” submitted unless otherwise indicated. Claims will continue to be processed during the suspension period. You will be notified about bill/claim determinations, including appeal rights regarding any bills/claims that are denied. The payment suspension also applies to claims in process. [INSERT the following paragraph IF the provider is going to be placed on prepayment review as part of the payment suspension.] Also, CMS [SELECT ONE: is continuing OR has implemented] the process of reviewing your Medicare claims and supporting documentation prior to payment. The purpose of the prepayment process is to ensure that all payments made by the Medicare program are appropriate and consistent with Medicare rules, regulations and policy. Notification is hereby given that you are expected to comply with the prepayment process for claims for all dates and services. Statutory Obligation to Return Overpayments As a Medicare provider, you are responsible for monitoring compliance with Medicare requirements. Upon discovering that payments were received in error, you are statutorily required to return the overpayments within 60 days. See § 1128J(d)(2) of the Social Security Act and 42 C.F.R. § 401.305. If you have any questions regarding the status of the suspension, please direct your inquiry to Click here to enter UPIC email address. Any request to remove the suspension must be submitted through the written rebuttal process described above. Sincerely, [UPIC Company Name] – A CMS Unified Program Integrity Contractor cc: Centers for Medicare & Medicaid Services B. Payment Suspension Initial Notice Based on Reliable Information (No Prior Notice Given) Date Name of Addressee (if known) Name of Medicare Provider/Supplier Address City, State Zip Re: Notice of Suspension of Medicare Payments Provider/Supplier Medicare ID Number(s): Provider/Supplier NPI: PSP Number: Dear {Medicare Provider/Supplier’s Name}: The purpose of this letter is to notify you of our determination to suspend your Medicare payments {INSERT THE FOLLOWING IF THIS IS A NATIONAL PAYMENT SUSPENSION: in all jurisdictions} pursuant to 42 C.F.R. § 405.371(a)(1). The suspension of your Medicare payments took effect on {ENTER DATE}. This payment suspension may last for up to 180 days from the effective date and may be extended under certain circumstances. See 42 C.F.R. § 405.372(d). Prior notice of this suspension was not provided, because giving prior notice would place additional Medicare funds at risk and hinder the Centers for Medicare & Medicaid Services’ (CMS) ability to recover any determined overpayment. See 42 C.F.R. § 405.372(a)(3) and (4). The CMS through its Central Office made the decision to suspend your Medicare payments. See 42 C.F.R. § 405.372(a)(4)(iii). The suspension of your Medicare payments is based on reliable information that an overpayment exists or that the payments to be made may not be correct. Specifically, the suspension of your Medicare payments is based on, but not limited to, information from claims data analysis and medical review completed by {NAME OF UPIC or MAC}. More particularly, {Continue with further supportive information and specific claim examples (no less than five). Only use claim numbers, date of service, amount paid and basis for selected claim when referencing the claim examples. Do Not use beneficiary names or HIC#s in the notice.}. The following list of sample claims provide evidence of our findings and serve as a basis for the determination to suspend your Medicare payments: Claim Control Number Date(s) of Service $$ Amount Paid Basis for Selected Claim This list is not exhaustive or complete in any sense, as the investigation into this matter is continuing. The information is provided by way of example in order to furnish you with adequate notice of the basis for this payment suspension. Pursuant to 42 C.F.R. § 405.372(b)(2), you have the right to submit a rebuttal statement in writing to us indicating why you believe the suspension should be removed. If you opt to do so, we request that you submit this rebuttal statement to us within 15 days and you may include with this statement any evidence supporting your reasons why the suspension should be removed. If you choose to submit a rebuttal statement, your rebuttal statement and any pertinent evidence should be sent to: {YOUR NAME}, Program Integrity Analyst {ADDRESS} If you submit a rebuttal statement, we will review that statement (and any supporting documentation) along with other materials associated with the case. Based on a careful review of the information you submit and all other relevant information known to us, we will determine whether the suspension should be removed or should remain in effect within 15 days of receipt of the complete rebuttal package, consistent with 42 C.F.R. § 405.375. However, the suspension of your Medicare funds will continue while your rebuttal package is being reviewed. See 42 C.F.R. § 405.375(a). Thereafter, we will notify you in writing of our determination to continue or remove the suspension and provide specific findings on the conditions upon which the suspension may be continued or removed, as well as an explanatory statement of the determination. See 42 C.F.R. § 405.375(b)(2). This determination is not an initial determination and is not appealable. See 42 C.F.R. § 405.375(c). If the suspension is continued, we will review additional evidence during the suspension period to determine whether claims are payable and/or whether an overpayment exists and, if so, the amount of the overpayment. See 42 C.F.R. § 405.372(c). We may need to contact you with specific requests for further information. You will be informed of developments and will be promptly notified of any overpayment determination. We will continue to process claims during the suspension period, and you will be notified about bill/claim determinations, including appeal rights regarding any bills/claims that are denied. The payment suspension also applies to claims in process. In the event that an overpayment is determined and it is determined that a recoupment of payments under 42 C.F.R. § 405.371(a)(3) should be put into effect, you will receive a separate written notice of the intention to recoup and the reasons. Please be advised that CMS may charge interest on the amount of the overpayment, consistent with 42 C.F.R. § 405.378. In the written notice alerting you to the overpayment, you will be given an opportunity for rebuttal in accordance with 42 C.F.R. § 405.374 from {MAC name}, CMS’ Medicare Administrative Contractor (MAC). When the payment suspension has been removed, any money withheld as a result of the payment suspension shall be applied first to reduce or eliminate any determined overpayment by CMS including any interest assessed under 42 C.F.R. § 405.378, and then to reduce any other obligation to CMS or to the U.S. Department of Health and Human Services in accordance with 42 C.F.R. § 405.372(e). In the absence of a legal requirement that the excess be paid to another entity, the excess will be released to you. {Insert the following paragraph if prepayment review is being initiated} Finally, {Name of UPIC or MAC}, a CMS {Unified Program Integrity Contractor (UPIC) or MAC}, has initiated a process to review your Medicare claims and supporting documentation prior to payment. The purpose of implementing this prepayment process is to ensure that all payments made by the Medicare program are appropriate and consistent with Medicare rules, regulations and policy. The prepayment process is often applied to safeguard Medicare from unnecessary expenditures and to ensure that Medicare payments are made for items and services which are “reasonable and necessary” for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. See 42 U.S.C. § 1395y(a)(1)(A). Notification is hereby given that you are expected to comply with the prepayment process for claims for all dates and services. Should you have any questions regarding the status of the suspension, please direct your inquiry to [shared mailbox]. Any request to remove the suspension must be submitted through the rebuttal process described above. Sincerely, Name C. Payment Suspension Initial Notice Based on Reliable Information (Prior Notice Given) Date Name of Addressee (if known) Name of Medicare Provider/Supplier Address City, State Zip Re: Notice of Suspension of Medicare Payments Provider/Supplier Medicare ID Number(s): Provider/Supplier NPI: PSP Number: Dear {Medicare Provider/Supplier’s Name}: The purpose of this letter is to notify you of our determination to suspend your Medicare payments {INSERT THE FOLLOWING IF THIS IS A NATIONAL PAYMENT SUSPENSION: in all jurisdictions} pursuant to 42 C.F.R. § 405.371(a)(1). The suspension of your Medicare payments will take effect on {ENTER DATE}. This payment suspension may last for up to 180 days from the effective date and may be extended under certain circumstances. See 42 C.F.R. § 405.372(d). The Centers for Medicare & Medicaid Services (CMS) through its Central Office made the decision to suspend your Medicare payments. See 42 C.F.R. § 405.372(a)(4)(iii). The suspension of your Medicare payments is based on reliable information that an overpayment exists or that the payments to be made may not be correct. Specifically, the suspension of your Medicare payments is based on, but not limited to, information from claims data analysis and medical review completed by {NAME OF UPIC or MAC}. More particularly, {Continue with further supportive information and specific claim examples (no less than five). Only use claim numbers, Date of Service and amount paid when referencing the claim examples. Do Not use beneficiary names or HIC#s in the notice.}. The following list of sample claims provide evidence of our findings and serve as a basis for the determination to suspend your Medicare payments: Claim Control Number Date(s) of Service $$ Amount Paid Basis for Selected Claim This list is not exhaustive or complete in any sense, as the investigation into this matter is continuing. The information is provided by way of example in order to furnish you with adequate notice of the basis for this payment suspension. Pursuant to 42 C.F.R. §§ 405.372(b)(2) and 405.374, you have the right to submit a rebuttal statement in writing to us within the next 15 days indicating why you believe the suspension should not be implemented or should be removed. If you opt to do so, you may include with this statement any evidence you believe is pertinent to your reasons why the suspension should not be implemented or should be removed. If you choose to submit a rebuttal statement, your rebuttal statement and any pertinent evidence should be sent to: {YOUR NAME}, Program Integrity Analyst {ADDRESS} If you submit a rebuttal statement, we will review that statement (and any supporting documentation) along with other materials associated with the case. Based on a careful review of the information you submit and all other relevant information known to us, we will determine whether the suspension should be implemented, removed, or should remain in effect within 15 days of receipt of the complete rebuttal package, consistent with 42 C.F.R. § 405.375. Thereafter, we will notify you in writing of our determination to implement, continue, or remove the suspension and provide specific findings on the conditions upon which the suspension may be implemented, continued, or removed, as well as an explanatory statement of the determination. See 42 C.F.R. § 405.375(b)(2). However, if by the end of this period no rebuttal has been received, the payment suspension will go into effect automatically. This determination is not an initial determination and is not appealable. See 42 C.F.R. § 405.375(c). If the suspension is implemented or continued, we will review additional evidence during the suspension period to determine whether claims are payable and/or whether an overpayment exists and, if so, the amount of the overpayment. See 42 C.F.R. § 405.372(c). We may need to contact you with specific requests for further information. We will inform you of developments and will promptly notify you of any overpayment determination(s). Claims will continue to be processed during the suspension period, and you will be notified about bill/claim determinations, including appeal rights regarding any bills/claims that are denied. The payment suspension also applies to claims in process. In the event that an overpayment is determined and it is determined that a recoupment of payments under 42 C.F.R. § 405.371(a)(3) should be put into effect, you will receive a separate written notice of the intention to recoup and the reasons. Please be advised that CMS may charge interest on the amount of the overpayment, consistent with 42 C.F.R. § 405.378. In the written notice alerting you to the overpayment, you will be given an opportunity for rebuttal in accordance with 42 C.F.R. § 405.374 from {MAC name}, CMS’ Medicare Administrative Contractor (MAC). When the payment suspension has been removed, any money withheld as a result of the payment suspension shall be applied first to reduce or eliminate any determined overpayment by CMS including any interest assessed under 42 C.F.R. § 405.378, and then to reduce any other obligation to CMS or to the U.S. Department of Health and Human Services in accordance with 42 C.F.R. § 405.372(e). In the absence of a legal requirement that the excess be paid to another entity, the excess will be released to you. {Insert the following paragraph if prepayment review is being initiated} Finally, {Name of UPIC or MAC}, a CMS {Unified Program Integrity Contractor (UPIC) or MAC}, has initiated a process to review your Medicare claims and supporting documentation prior to payment. The purpose of implementing this prepayment process is to ensure that all payments made by the Medicare program are appropriate and consistent with Medicare rules, regulations and policy. The prepayment process is often applied to safeguard Medicare from unnecessary expenditures and to ensure that Medicare payments are made for items and services which are “reasonable and necessary” for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. See 42 U.S.C. § 1395y(a)(1)(A). Notification is hereby given that you are expected to comply with the prepayment process for claims for all dates and services. Should you have any questions regarding the status of the suspension, please direct your inquiry to [shared mailbox]. Any request to remove the suspension must be submitted through the rebuttal process described above. Sincerely, Name D. Reliable Information that an Overpayment Exists (RIO) Payment Suspension Extension Notice Date Name of Addressee (if known) Name of Medicare Provider/Supplier Address City, State Zip Re: Notice of Extension of Suspension of Medicare Payments Provider/Supplier Medicare ID Number(s): Provider/Supplier NPI: PSP Number: Dear {Medicare Provider/Supplier’s Name}: Please be advised that pursuant to 42 C.F.R. § 405.372(d), the Centers for Medicare & Medicaid Services (CMS) has directed {ENTER UPIC NAME}, CMS’ Unified Program Integrity Contractor, to continue the suspension of your Medicare payments for an additional 180 days effective {Enter Date that the payment suspension was to expire}. The extension of your payment suspension applies to claims in process. We will continue to withhold your Medicare payments until an investigation of the circumstances has been completed in accordance with 42 C.F.R. § 405.372(d). When the payment suspension is terminated, any money withheld as a result of the payment suspension shall be applied first to reduce or eliminate any determined overpayment by CMS including any associated interest accrued pursuant to 42 C.F.R. § 405.378, and then to reduce any other obligation to CMS or the U.S. Department of Health and Human Services. See 42 C.F.R. § 405.372(e). In the absence of a legal requirement that the excess be paid to another entity, the remainder will be released to you. Should you have any questions regarding the status of the suspension, please direct your inquiry to [shared mailbox]. Sincerely, Name E. Credible Allegation of Fraud (CAF) Payment Suspension Extension Notice Date To: Attn: [Point of Contact] [Provider Name] [Provider Street Address] [Provider City, State Zip code] Reference Number: Provider Name: Provider Medicare ID Number (s): Provider NPI: Subject: Payment Suspension Extension Notice Dear [Point of Contact]: As previously advised in the Notice of Payment Suspension dated [date], the Centers for Medicare & Medicaid Services (CMS) suspended payments to [Provider/Supplier Name (“Shortened Name”)] based upon credible allegations of fraud under 42 C.F.R. § 405.371(a)(2). CMS regulations authorize payment suspensions based upon credible allegations of fraud to continue until resolution of the investigation including termination of any civil or criminal proceedings. See 42 C.F.R. § 405.370 (defining “resolution of an investigation”) and § 405.372(d)(3)(ii). Consistent with 42 C.F.R. § 405.371(b), CMS has (1) evaluated whether there is good cause to not continue the payment suspension and (2) received a certification from the Office of Inspector General (OIG) or other law enforcement agency that the matter continues to be under investigation warranting continuation of the suspension. We are writing to inform you that the payment suspension remains in place. The maintenance of your payment suspension applies to claims in process. When the payment suspension is terminated, any money withheld as a result of the payment suspension shall be applied first to reduce or eliminate any determined overpayment by CMS including any interest assessed under 42 C.F.R. § 405.378, and then to reduce any other obligation to CMS or the U.S. Department of Health and Human Services. See 42 C.F.R. § 405.372(e). In the absence of a legal requirement that the excess be paid to another entity, the excess will be released to you. Should you have any questions regarding the status of the suspension, please direct your inquiry to [UPIC Email address]. Sincerely, [UPIC PoC] Program Integrity Manager [Region] Unified Program Integrity Contractor [Name of UPIC] [Telephone] F. Payment Suspension Termination Notice USE THIS LETTER IF SENDING PAYMENT SUSPENSION TERMINATION NOTICE TO THE PROVIDER’S/SUPPLIER’S ATTORNEY Date Name of Attorney Address City, State Zip Re: Notice of Commencement of Process for Termination of Suspension of Medicare Payments Provider/Supplier Medicare ID Number(s): Provider/Supplier NPI: Record Identifier(s): Dear {Medicare Provider/Supplier Attorney’s Name}: The Centers for Medicare & Medicaid Services (CMS) has directed us to commence the process to terminate the payment suspension in effect for Medicare payments to [provider] pursuant to 42 C.F.R. § 405.372(c). The provider was notified of the results of our review and the overpayment(s) we determined on [INSERT DATE]. The overpayment information was forwarded to [INSERT MAC], CMS’ Medicare Administrative Contractor (MAC) for further action. As part of that process, the MAC will review our findings and will issue the overpayment demand letter(s), along with information regarding the provider’s appeal rights. The MAC typically will complete the process to terminate the suspension within approximately 60 days. Once the payment suspension is terminated, any funds withheld as a result of the payment suspension shall be applied first to reduce or eliminate any overpayments determined by CMS including any associated interest accrued pursuant to 42 C.F.R. § 405.378 and then to reduce any other obligation to CMS or the U.S. Department of Health and Human Services per 42 C.F.R. § 405.372(e). In the absence of a legal requirement that the excess be paid to another entity, the excess will be released to the provider. Please be advised that the termination of the payment suspension should not be construed as a positive determination regarding the provider’s Medicare billing and is not an indication of government approval of or acquiescence regarding the claims submitted. It does not relieve the provider of any civil or criminal liability, and it does not offer a defense to any further administrative, civil or criminal actions against the provider. Sincerely, Name G. Payment Suspension Termination Notice USE THIS LETTER IF SENDING PAYMENT SUSPENSION TERMINATION NOTICE TO THE PROVIDER/SUPPLIER Date Name of Addressee (if known) Name of Medicare Provider/Supplier Address City, State Zip Re: Notice of Commencement of Process for Termination of Suspension of Medicare Payments Provider/Supplier Medicare ID Number(s): Provider/Supplier NPI: Record Identifier(s): Dear {Medicare Provider/Supplier’s Name}: The Centers for Medicare & Medicaid Services (CMS) has directed us to commence the process to terminate the payment suspension in effect for Medicare payments to [provider] pursuant to 42 C.F.R. § 405.372(c). You were notified of the results of our review and the overpayment(s) we determined on [INSERT DATE]. The overpayment information was forwarded to [INSERT MAC], CMS’ Medicare Administrative Contractor (MAC), for further action. As part of that process, the MAC will review our findings and issue the overpayment demand letter(s), along with information regarding your appeal rights. Typically, the MAC will complete the process to terminate the suspension within approximately 60 days. Once the payment suspension is removed, any funds withheld as a result of the payment suspension shall be applied first to reduce or eliminate any overpayments determined by CMS including any associated interest accrued pursuant to 42 C.F.R. § 405.378 and then to reduce any obligation to CMS or the U.S. Department of Health and Human Services per 42 C.F.R. § 405.372(e). In the absence of a legal requirement that the excess be paid to another entity, the excess will be released to you. Please be advised that the termination of a payment suspension should not be construed as any positive determination regarding your Medicare billing and is not an indication of government approval of or acquiescence regarding the claims submitted. It does not relieve you of any civil or criminal liability, and it does not offer a defense to any further administrative, civil or criminal actions against you. Sincerely, Name Exhibit 17 – Signature Attestation Form (for missing or illegible signatures) (Rev.) Exhibit 18 - Corrective Action Reporting Formats (Rev. 617, Issued: 10-09-15, Effective: 11-10-15, Implementation: 11-10-15) A. Corrective Actions Taken on CMS Identified Vulnerabilities: (A/B)/(DME) MACs Contractor Name and Jurisdiction: (To be completed by MAC) Date Report Submitted to CMS: (To be completed by MAC) New Issue Number Issue Description Interim Response Final Response Additional Comments Updated Responses B. Overpayment Recovery on OIG Claims Format Contractor Name and Jurisdiction: (To be completed by MAC) Date Report Submitted to CMS: (To be completed by MAC) OIG Report Number (e.g. A-01-09-00050) (completed by MAC) Overpayment Recovery (in dollars) (completed by MAC) OPTIONAL Overpayments referred or uncollectable (in dollars) (completed by MAC) Reason for no review of claims and no recovery (if applicable) (completed by MAC) Final Reporting Date for this audit (completed by CMS) Other Additional Comments or Actions Taken (if applicable) Exhibit 19 – Reserved for Future Use – (Rev.) Exhibit 20 – Reserved for Future Use - (Rev. ) Exhibit 21 – Regional Home Health Intermediaries/Jurisdictions - (Rev. 3, 11- 22-00) Associated Hospital Services of Maine Connecticut Maine Massachusetts New Hampshire Rhode Island Vermont Palmetto Government Benefits Administration Alabama Arkansas Florida Georgia Illinois Indiana Kentucky Louisiana Mississippi New Mexico North Carolina Ohio Oklahoma South Carolina Tennessee Texas Blue Cross of California Alaska American Samoa Arizona California Guan Hawaii Idaho Nevada Northern Mariana Islands Oregon Washington United Government Services Michigan Minnesota New Jersey New York Puerto Rico Virgin Islands Wisconsin Wellmark, Inc Colorado Delaware District of Columbia Iowa Kansas Maryland Missouri Montana Nebraska North Dakota Pennsylvania South Dakota Utah Virginia West Virginia Wyoming Exhibit 22 - Office of Inspector General, Office of Investigations Field Offices (Rev. 3, 11-22-00) Street Address Mailing Address States BOSTON: Room 1405 JFK Federal Bldg. Boston, MA 02203 (617) 565-2660 HHS, OS, OIG, OI P.O. Box 8767 Boston, MA 02114 Connecticut Maine Massachusetts New Hampshire Rhode Island Vermont NEW YORK Room 3900 B Federal Building New York, NY 10278 (212) 264-1691 HHS, OS, OIG, OI P.O. Box 3209 Church St. Station New York, NY 10008 New Jersey New York Puerto Rico Virgin Islands PHILADELPHIA Room 4430 3535 Market Street Philadelphia, PA 19104 (215) 596-6796 HHS, OS, OIG, OI P.O. Box 8049 Philadelphia, PA 19101 Delaware Pennsylvania West Virginia Maryland Except: - Prince Georges County - Montgomery County Virginia Except: - Fairfax County - Arlington County - City of Alexandria - City of Falls Church ATLANTA Room 1404 101 Marietta Tower Atlanta, GA 30323 (404) 331-2131/2556 HHS, OS, OIG, OI P.O. Box 2288 Atlanta, GA 30301 Alabama Florida Georgia Kentucky Mississippi North Carolina South Carolina Tennessee CHICAGO 23rd Floor 105 West Adams St. Chicago, IL 60603 (312) 353- 2740 HHS, OS, OIG, OI 23rd Floor 105 West Adams Street Chicago, IL 60603 Illinois Indiana Michigan Minnesota Ohio Wisconsin Missouri Iowa DALLAS Room 4E1B HHS, OS, OIG, OI Room 4E1B Arkansas Louisiana 1100 commerce St. Dallas, TX 75242 (214) 767-8406 1100 Commerce St. Dallas, TX 75242 New Mexico Oklahoma Texas DENVER Room 327 1961 Stout Street Federal Office Bldg. Denver, CO 80294- 3546 (303) 844-5621 HHS, OS, OIG, OI 1961 Stout Street Denver, CO 80294- 3546 Colorado Kansas Montana Nebraska North Dakota South Dakota Wyoming</> Utah SAN FRANCISCO Room 174 50 U.N. Plaza San Francisco, CA 94102 (415) 556-8880 HHS, OS, OIG, OI P.O. Box 42516 San Francisco, CA 94142-2516 Arizona California Guam Hawaii Nevada Samoa SEATTLE SUB OFFICE Room 209, RX-81 2201 Sixth Avenue Seattle, WA 98121 (206) 442-0547 HHS, OS, OIG, OI P.O. Box 61220 Seattle, WA 98121 Alaska Idaho Oregon Washington WASHINGTON, D.C. Field Office Room 5193 Cohen Bldg. 330 Independence Av. SW Washington, DC 20201 (202) 619-1900 HHS, OS, OIG, OI Room 5193 Cohen Bldg. 330 Independence Av SW Washington, DC 20201 District of Columbia Maryland Counties: - Prince Georges - Montgomery Counties - Virginia Counties Virginia Cities - Alexandria - Falls Church Exhibit 23 - PIM Acronyms - (Rev. 3, 11-22-00) Acronym Meaning ABG Arterial Blood Gas ABN Advanced Beneficiary Notice AC Affiliated Contractor ADL Activities of Daily Living ADMC Advance Determination of Medicare Coverage AIDE Home Health Aide AKA Also Known As ALJ Administrative Law Judge AMA American Medical Association AoA Administration on Aging ASC Ambulatory Surgical Center AUSA Assistant United States Attorney BESS Part B Extract Summary System BI Benefit Integrity CAC Carrier Advisory Committee CBR Cost Benefit Ratio CFO Chief Financial Office CHAMPUS Civilian Health and Medical Program of the Uniformed Services CMD Contractor Medical Director CMN Certificate of Medical Necessity CMP Civil Monetary Penalty CMPL Civil Monetary Penalties Law CMR Comprehensive Medical Review CMS Centers for Medicare & Medicaid Services CO Central Office COB Coordination of Benefits CORF Comprehensive Outpatient Rehabilitation Facility CPE Contractor Performance Evaluation CPT Current Procedural Terminology CWF Common working File DAP DMERC Advisory Panel DBA Doing Business As DHHS Department of Health and Human Services DME Durable Medical Equipment DMEPOS Durable Medical Equipment, Prosthetic, and Orthotic Supplier DMERC Durable Medical Equipment Regional Carrier DOJ Department of Justice DRG Diagnosis Related Groups DX Diagnosis EMC Electronic Media Claims EOMB Explanation of Medicare Benefits EPO Epoetin ESRD End Stage Renal Dialysis FBI Federal Bureau of Investigation FHIBA Federal Health Insurance Benefits Accounts FI Fiscal Intermediary FID Fraud Investigation Database FMR Focused Medical Review FTE Full Time Equivalent FY Fiscal Year GAO General Accounting Office GPRA Government Performance Results Act GTL Government Task Leader HCFA Health Care Financing Administration HCIS Healthcare Customer Information System HCPCS Healthcare Common Procedure Coding System HHA Home Health Agency HHS Health and Human Services HI Health Insurance HICN Health Insurance Claim Number HIPAA Health Insurance Portability and Accountability Act of 1996 HO Hearings Officer ICN/DCN Internal Control Number/Document Control Number IER Interim Expenditure Report IRP Incentive Reward Program IRS Internal Revenue Service LMRP Local Medical Review Policy MCM Medicare Carrier Manual MFCU Medicaid Fraud Control Unit MFIS Medicare Fraud Information Specialist MFSR Medicare Focused Medical Review Status MIM Medicare Intermediary Manual MIP Medicare Integrity Program MIP-PET Medicare Integrity Program-Provider Education and Training MR Medical Review MSN Medicare Summary Notice MSP Medicare Secondary Payer MSS Medical social Services N/A Not Applicable NCP National Coverage Policy NMFA National Medicare Fraud Alert NOU Notice of Utilization NPR National Performance Review NSC National Supplier Clearinghouse OCIG Office of Counsel to the Inspector General OCSQ Office of Clinical Standards and Quality OIFO Office of Investigations Field Office OIG Office of Inspector General OIGOAS Office of Inspector General Office of Audit Services OIG/OI Office of Inspector General Office of Investigations OP Outpatient OPT Outpatient Physical Therapy OT Occupational Therapy PAL Provider Audit List PI Program Integrity PIM Program Integrity Manual PIN Provider Identification Number PIP Periodic Interim Payments PM Program Memorandum PM-PET Program Management-Provider Education and Training POC Plan of Care PPAC Practicing Physicians Advisory Council PPS Prospective Payment System PRO Peer Review Organization PRRB Provider Reimbursement Review Board PSC Program Safeguard Contractor PS&R Provider Statistical and Reimbursement PT Physical Therapy PTS Provider Tracking system QA Quality Assurance QIO Quality Improvement Organization RBS Report of Benefit Savings RCCO Regional Chief Counsel's Office RHC Rural Health Clinic RHHI Regional Home Health Intermediary RMFA Restricted Medicare Fraud alert RMRP Regional Medical Review Policy RO Regional Office ROM Range of Motion RRB Railroad Retirement Board RT Record Type RVU Relative Value Unit SADMERC Statistical Analysis Durable Medical Equipment Regional Carrier SLP Speech-Language Pathology SMI Supplementary Medical Insurance SME Subject Matter Expert SN Skilled Nursing SNF Skilled Nursing Facility SOC Start of Care SSA Social Security Administration SSAFO Social Security Administration Field Office ST Speech Therapy SUR State Utilization Review Units the Act the Social Security Act TOB Type of Bill TPN Total Parenteral Nutrition UPIN Unique Physician Identification Number Exhibit 25 – Procedures and Forms for Obtaining Protected Health Information (Rev. 10228; Issued: 07-27-20; Effective: 08-27-20; Implementation: 08-27-20) Office of the Director U.S. Department of Justice Executive Office for United States Attorneys Room 2616, RFK Main Justice Building 950 Pennsylvania Avenue, NW Washington, DC 20530 (202) 514-2121 MEMORANDUM -Sent via Electronic Mail DATE: April 11, 2003 TO: ALL UNITED STATES A TTORNEYS ALL FIRST ASSISTANT UNITED STATES ATTORNEYS ALL CRIMINAL CHIEFS ALL CIVIL CHIEFS FROM: Guy A. Lewis Director SUBJECT: Procedures and Forms for Obtaining Protected Health Information in Law Enforcement and Health Oversight Investigations; Guidance Materials Concerning New HIPAA Privacy Regulations. ACTION REQUIRED: Please distribute to all Assistant United States Attorneys. CONTACT PERSONS: Cam Towers Jones Health Care Fraud Coordinator Legal Programs Telephone: (202) 353-8507 Andrea Gross Affirmative Civil Enforcement Coordinator Legal Programs Telephone: (202) 305-3346 New medical privacy rules (located at 45 C.F .R., Parts 160 and 164) take effect on Monday, Apri114, 2003. These rules will affect all Assistant United States Attorneys (AUSAs) who obtain medical information in the course of their work. In order to assist AUSAs, the Executive Office for United States Attorneys (EOUSA) and the Civil and Criminal Divisions of the Department of Justice have prepared form materials which can be used to obtain medical records in law enforcement and health oversight investigations. Attached is a WordPerfect document titled "Updated Process, Model Letters, and Forms to Request Protected Health Information Pursuant to the HIPAA Privacy Regulation." This document includes (1) a description of the process for obtaining Centers for Medicare and Medicaid Services (CMS) data after Apri114, 2003; (2) a form letter to be used in requesting information from CMS contractors; (3) a form letter to be used in requesting protected health information from entities other than CMS contractors (including federal agencies in affirmative civil and criminal health care fraud cases; and (4) potential paragraphs to be inserted in letters, subpoenas, or other forms of legal process requesting production of protected health information. EOUSA and the Civil and Criminal Divisions of the Department of Justice have also prepared guidance about the regulation in a "question and answer" format. These guidance materials were distributed at the recent Health Care Fraud Coordinators Conference at the National Advocacy Center. An additional copy is also attached to this memorandum, for your information. Copies of the documents attached to this memorandum will also be posted on the EOUSA ACEO and Health Care Fraud Web Page at: http://www.usa.doj.gov/staffs/lp/ace/. If you have any questions regarding implementation of the privacy regulations, you may contact one of the people listed below: Dan Anderson (Affirmative Civil) Civil Division (202) 616-2451 Ian DeWaal (Criminal) Criminal Division (202) 514-0669 Jim Gilligan (Civil Defensive/Federal Programs) Civil Division (202) 514-3358 Andrea Gross (Affirmative Civil) Executive Office for United States Attorneys (202) 305-3346 Cam Towers Jones (Criminal) Executive Office for United States Attorneys (202) 353-8507 Sherri Keene (Civil DefensiveIFTCA) Civil Division (202) 616-4272 Karen Morrissette (Criminal) Criminal Division (202) 514-0640 Attachments cc: All United States Attorneys' Secretaries UPDATED PROCESS, MODEL LETTERS AND FORMS TO REQUEST PROTECTED HEALTH INFORMATION PURSUANT TO THE PRIVACY ACT AND HIPAA PRIVACY RULE Table of Contents Page 2: Updated Process for Law Enforcement Agency Requests to Obtain CMS/Medicare data. Page 4: Letter to request protected health information from the Centers for Medicare & Medicaid Services or from CMS’s contractors (disclosure of data in CMS Systems of Records). Page 6: Letter to request protected health information from other covered entities (including other federal agencies in affirmative civil and criminal health care fraud cases). Page 7: Potential paragraphs to be inserted in letters (or subpoenas, etc) requesting production of protected health information. Page 8: Health oversight Page 9: Required by law Page 10: Whistleblowers/victims of workplace crime Page 11: Disclosures for law enforcement purposes pursuant to process and as otherwise required by law. Page 12: Disclosures of information about victims of crimes for law enforcement purposes in response to a law enforcement request. Page 13: Disclosures about victims of abuse, neglect or domestic violence. Page 14: Locate and Identify Page 15: Decedents Page 16: Correctional institutions and other law enforcement custodial situations Page 17: Judicial/Administrative Page 18: Minimum Necessary Page 19: Insert Only When Suspension of Notification to Individual is Desired Page 20: Patient Authorizations Page 21: Patient Authorization to Release Medical Information Page 23: Patient Authorization to Release Psychotherapy Information Updated Process for Law Enforcement Agency Requests to Obtain CMS/Medicare Data 1. The law enforcement agency should begin by consulting with the appropriate Medicare contractor (usually the Unified Program Integrity Contractor, but possibly also the Carrier, Fiscal Intermediary, Quality Improvement Organization, or CMS) to discuss the purpose or goal of the data request. To illustrate, are data being sought to assess allegations of fraud; examine billing patterns; ascertain dollar losses to the Medicare program for a procedure, service or time period; conduct a random sample of claims for medical review, etc? Upon receiving a data request from a law enforcement agency, the Medicare contractor (e.g., UPIC) will examine its sources of data for most recent 36-month period for the substantive matter/s in question or for the specific period requested by the law enforcement agency, if necessary. In consultation with the Medicare contractor, the law enforcement agency also should make known the following: · type of data and “fields of information” needed · name and/or other identifying information for provider/s (e.g., Tax Identification Number, Unique Physican Identification Number, etc.) · time period necessary for the inquiry (approximate begin and end dates if the conduct is not ongoing currently), and · format or medium for data to be provided (i.e., tape, CD-ROM, paper, etc.). 2. As part of the initial consultation process, the Medicare contractor and law enforcement agency should develop appropriate language to insert in the data request “standard form letter.” (A copy of an updated “standard form letter” from the law enforcement agency to Medicare contractor, along with various template paragraphs for insertion in the letter to ensure Privacy Act and HIPAA Privacy Rule compliance, are provided as attachments.) After consulting with the appropriate Medicare contractor, the law enforcement agency should send the signed standard form letter, identifying the appropriate authority under which the information is being sought and specifying the details of the request described above, to the Medicare contractor. The Medicare contractor will provide the relevant data, reports and findings to the requesting agency in the format/s requested within 30 days when data for the most recent 36-month period is being sought directly from the Medicare contractor. If it is necessary for the Medicare contractor to seek and acquire other data from CMS or another affiliated Medicare contractor, the time period required to provide the data to the requesting agency will extend beyond 30 days. (Currently, the average response period for data requests made to CMS is 14 weeks.) 1 3. If appropriate, the Medicare contractor will also use analytic tools to look for other possible indicia of fraud in addition to the specific alleged conduct that was the cause of the law enforcement agency’s data request. 4. If, in the view of the requesting law enforcement agency, the Medicare contractor, or CMS, the Medicare contractor’s “initial 36-month review” generally verifies the fraud allegations, or if potential fraud is uncovered through the use of analytic tools, and upon a subsequent request, the Medicare contractor will conduct a supplemental review of Medicare data. The supplemental review will meet the specific needs of the law enforcement agency based on the allegations under investigation and/or findings of the initial 36-month review. Such supplemental reviews may involve retrieving information from original Carrier and/or Fiscal Intermediary data files, as well as the National Claims History (NCH), Common Working File (CWF), or other Medicare data files that may be archived in order to cover the complete time frame involved in the allegations and/or allowed by the statute of limitations. The time period for fulfilling supplemental data requests will be negotiated on a case-by-case basis between CMS and the law enforcement agency making the data request. 5. While steps 1-4 describe the usual process to be followed for handling law enforcement agency requests for CMS/Medicare data, exceptions to this process will be necessary on a case- by-case basis when the law enforcement agency determines that conducting an initial review of the most recent 36-months of data would not be sufficient. For example, exceptions will be necessary if: a. The most recent 36 months of data would not be helpful to the investigation because the fraud being investigated is alleged to have occurred prior, or in large part prior to, that period. b. Changes in the payment system used for the type/s of claims in question cause the most current data to be inappropriate for attempting to verify allegations of possible fraud that occurred under a previous payment system. c. The purpose of the data request cannot be met using only the most recent 36 months of data (e.g., a statistical sampling plan that requires more than 36 months of data to implement the plan correctly and accurately). d. Litigation deadlines preclude conducting an initial review followed by a more comprehensive supplemental review. e. Items 5 a-d are illustrative not exhaustive. 6. Each agency (DOJ, FBI, CMS, etc.) will designate a “contact person” for advising their internal agency components and field offices about this updated process for making data requests to CMS/Medicare contractors, and for resolving any conflicts or disagreements that may occur involving specific requests for information. USE DEPARTMENT OF JUSTICE LETTERHEAD [DATE] If this request for data is made to a Unified Program Integrity Contractor, Quality Improvement Organization (QIO), Fiscal Intermediary (FI), or Carrier, address to: Name of contact person Name of the UPIC, QIO, FI, or Carrier Address and send a “cc:” to: Regional Office of the Inspector General Director, Benefit Integrity and Law Enforcement Liaison, CMS If this request for data is made to CMS, address to: Centers for Medicare & Medicaid Services Office of Financial Management Program Integrity Group Director, Benefit Integrity and Law Enforcement Liaison C3-02-16 7500 Security Blvd Baltimore, MD 21244 and send a “cc:” to: Regional Office of the Inspector General Re: Request for disclosure of data in CMS Systems of Records Dear [insert name]: This letter is to request your assistance in obtaining CMS data from the [insert file name] on [insert type of data needed and providers for which data is needed] for claims during the following time period: [insert time period]. Please provide this data in [specify format, i.e., CD, tape, disk, paper, etc.] directly to [insert name, address, telephone number, and role of the person in connection with the case]. Instructions to DOJ attorney or investigator filling out letter: INSERT APPROPRIATE PARAGRAPHS FROM THE ALTERNATIVES, ATTACHED, Beginning at page 7. Additionally, to ensure Privacy Act compliance, CMS has issued and published routine uses authorizing disclosure of data in CMS systems of records for such purposes. See 63 Federal Register 38414, July 16, 1998. The focus of our examination is the following: [insert general description of the nature of the law enforcement or health oversight activity being pursued]. You can be assured that the DOJ will take all appropriate measures to ensure that this data will be maintained and used in compliance with Section VI (Confidentiality Procedures) of the Health Care Fraud and Abuse Control Program Guidelines agreed to by the Attorney General and the Secretary of the Department of Health and Human Services under the Health Insurance Portability and Accountability Act of 1996. I understand that CMS does not commit to processing my request if the estimated cost of doing so exceeds $200,000, and that a CMS representative will contact me if the estimated cost exceeds that amount. Additionally, I understand that CMS officials may intercede should a DOJ request for CMS data create a substantial resource impact on the data processing capabilities of the CMS Data Center, a Medicare Fiscal Intermediary, Carrier, Unified Program Integrity Contractor, QIO, or other contractor. For requests initiated by the FBI or United States Attorney’s offices, discussions to resolve such resource issues will be conducted between the appropriate CMS official and the appropriate FBI agent or Assistant United States Attorney (AUSA), or if necessary, the appropriate FBI or AUSA supervisor. For requests initiated by DOJ headquarters, or where regional resolution has been unsuccessful, CMS officials may refer such resource issues to the appropriate DOJ headquarters official. Thank you for your assistance with this matter. Please call me at [insert phone #] if you have any questions about this request. Sincerely, [name, title, and office of DOJ official] USE DEPARTMENT OF JUSTICE LETTERHEAD MODIFY AS APPROPRIATE FOR YOUR INVESTIGATION AND FOR THE PARTICULAR RECIPIENT OF THE REQUEST (E.G., SUBPOENAED PERSON) [DATE] Re: Request for production of protected health information Dear [insert name]: This letter is to request that you produce information/data from [source of records] on [insert type of data/information needed and providers for which information is needed] for claims during the following time period: [insert time period]. Please provide this information/data in [specify format, i.e., CD, tape, disk, paper, etc.] directly to [insert name, address, telephone number, and role of the person in connection with the case.] Instructions to DOJ attorney or investigator filling out letter: INSERT APPROPRIATE PARAGRAPHS FROM THE ALTERNATIVES, ATTACHED, Beginning at page 7. Thank you for your assistance with this matter. Please call me at [insert phone #] if you have any questions about this request. Sincerely, [name, title, office of DOJ official] POTENTIAL PARAGRAPHS TO BE INSERTED IN LETTERS (OR SUBPOENAS, ETC) REQUESTING PRODUCTION OF PROTECTED HEALTH INFORMATION. PLEASE READ ALL PARAGRAPHS AND ENSURE THAT YOU HAVE INCLUDED ALL NECESSARY PROVISIONS. HEALTH OVERSIGHT You are requested to produce this information to the Department of Justice in its capacity as a health oversight agency, and this information is necessary to further health oversight activities. 45 C.F.R. 164.512(d); 45 C.F.R. 164.501. REQUIRED BY LAW The information sought in this request is required by law to be produced to the Department of Justice, pursuant to , (cite the applicable law or reference the legal process that is attached to this document.) Disclosure is therefore permitted under 45 C.F.R. 164.512(a). (NOTE TO DRAFTER: IF THIS REQUEST ALSO FALLS WITHIN THE PROVISIONS OF 45 C.F.R. 164.512 (c), (e), OR (f). THEN YOU MUST ALSO MEET THE REQUIREMENT OF THAT SUBSECTION AND YOU MUST ALSO ASSERT THAT YOU HAVE MET THAT REQUIREMENT. IF YOUR “REQUIRED BY LAW” REQUEST IS MADE IN A HEALTH OVERSIGHT CAPACITY, YOU SHOULD ASSERT THIS FACT SO THAT THE RECIPIENT OF THE REQUEST UNDERSTANDS THAT NO ADDITIONAL REQUIREMENTS NEED BE MET. 45 C.F.R. Section 164.512(d)(1)) WHISTLEBLOWERS/VICTIMS OF WORKPLACE CRIME (See 65 Fed. Reg. 250, page 82492) This request for information is made to you in your capacity as a whistleblower, described at 45 C.F.R. 164.502(j)(l)(i) as “[an individual who] believes in good faith that the covered entity has engaged in conduct that is unlawful or otherwise violates professional or clinical standards, or that the care, services, or conditions provided by the covered entity potentially endangers one or more patients, workers, or the public. . .” You are requested to produce the information described in Attachment A, hereto, to the Department of Justice in its capacity as a health oversight agency, as permitted by 45 C.F.R. 164.502(j)(l)(ii). OR This request for information is made to you in your capacity as a victim of a criminal act and a member of the workforce of a covered entity. You are providing information about the suspected perpetrator of the criminal act, and should limit your disclosure to the following information: a) name and address; b) date and place of birth; c) social security number; d) ABO blood type and Rh factor; e) type of injury; f) date and time of treatment; g) date and time of death; h) distinguishing physical characteristics. This request is made pursuant to 45 C.F.R. 164.502(j)(2). Disclosures for law enforcement purposes pursuant to process and as otherwise required by law (45 CFR 164.512(f)(1)) The undersigned hereby represents that this request for protected health information is made by a law enforcement agency [specify agency] for law enforcement purposes and is permitted by 45 CFR 164.512(f)(1) in that: [INSERT PARAGRAPH (i), (iiA), (iiB), OR (iiC) BELOW] (i) the disclosure is required by law [specify the law]; OR (iiA) the disclosure is in compliance with and limited by the relevant requirements of a court order or court-ordered warrant, or a subpoena or summons issued by a judicial officer [attach relevant copies]; OR (iiB) the disclosure is in compliance with and limited by the relevant requirements of a grand jury subpoena [attach copy]; OR (iiC) the disclosure is in compliance with and limited by the relevant requirements of an administrative request, including an administrative subpoena or summons, a civil or authorized investigative demand, or similar process authorized by law [attach copy]. The undersigned further represents that the information sought is relevant and material to a legitimate law enforcement inquiry, the request is specific and limited in scope to the extent reasonably practicable in light of the purpose for which the information is sought, and de-identified information could not reasonably be used. Disclosures of information about victims of crimes for law enforcement purposes in response to a law enforcement request (45 CFR 164.512(f)(3)) The undersigned hereby represents that this request for protected health information is made by a law enforcement agency [specify agency] for law enforcement purposes and is permitted by 45 CFR 164.512(f)(3) in that the requested information is about an individual who is or is suspected to be a victim of a crime and that: [INSERT PARAGRAPH (i) OR (ii) BELOW] (i) the individual has agreed to the disclosure [specify manner of agreement and/or attach written evidence of agreement]; (examples at page 23) OR (ii) the covered entity is unable to obtain the individual’s agreement because of incapacity or other emergency circumstance [specify nature of incapacity or emergency circumstance]. The undersigned law enforcement official represents that: the requested information is needed to determine whether a violation of law by a person other than the victim has occurred, and that such information is not intended to be used against the victim; immediate law enforcement activity which depends upon the disclosure would be materially and adversely affected by waiting until the individual is able to agree to the disclosure. The undersigned further asserts that the circumstances are such that the covered entity, in the exercise of its professional judgment, should determine that the disclosure is in the best interests of the individual. Disclosures about victims of abuse, neglect or domestic violence (45 C.F.R. 164.512(c)) If the covered entity reasonably believes that the individual (whose personally identifiable health information is requested) is a victim of abuse, neglect or domestic violence, this request for information is permitted by 45 C.F.R. 164.512(c)(1) because the disclosure is to ____________________, which is a government agency authorized by law to receive reports of such abuse, neglect, or domestic violence, and: [INSERT PARAGRAPH (i) or (ii) or either (iiiA) or (iiiB) below] i) the disclosure is required by law [specify the law] and complies with and is limited to the relevant requirements of such law; OR ii) the individual has agreed to the disclosure [specify manner of agreement and/or attach written evidence of agreement]; OR, EITHER iiiA) the disclosure is expressly authorized by statute or regulation, namely, [specify the law] and the covered entity believes the disclosure is necessary to prevent serious harm to the individual or other potential victims; OR iiiB) the disclosure is expressly authorized by statute or regulation [specify the law] and the individual is unable to agree because of incapacity [specify nature of incapacity], and the recipient law enforcement or public official authorized to receive the report [specify the agency] hereby represents that the protected health information which is sought is not intended to be used against the individual. The [specify agency] further represents that an immediate enforcement activity depends on the disclosure and would be materially and adversely affected by waiting until the individual is able to agree to the disclosure. Locate and Identify This request for protected health information is made by a law enforcement agency pursuant to the provisions of 45 C.F.R. 164.512(f)(2) which permit the disclosure of the enumerated limited information for identification and location purposes. A covered entity is permitted to make a disclosure to a law enforcement officer under this paragraph for the purpose of identifying or locating a suspect, fugitive, material witness or a missing person. The following information may be disclosed: (A) name and address; (B) date and place of birth; (C) social security number; (D) ABO blood type and rh factor; (E) type of injury; (F) date and time of treatment; (G) date and time of death (if applicable); (H) a description of distinguishing physical characteristics, including, height, weight, gender, race, hair and eye color, presence or absence of facial hair (beard or moustache), scars and tattoos. Decedents (NOTE: This section of the regulation can only be used to permit a disclosure to a coroner, pursuant to a request by a coroner. Therefore, it will seldom be used in connection with requests in federal investigations, and even in those cases, the request must originate from a coroner.) This request for protected health information is made by a [coroner] [medical examiner] pursuant to the provisions of 45 C.F.R. 164.512(g) which permit a covered entity to disclose protected health information to a coroner or medical examiner for the purpose of identifying a deceased person, determining a cause of death, or other duties as authorized by law. Correctional institutions and other law enforcement custodial situations This request for protected health information is made by a [correctional institution][law enforcement agency] with lawful custody of [fill in name of prisoner/detainee]. The undersigned represents that the protected health information is necessary for (check all that apply): ( ) the provision of health care to this individual; ( ) the health and safety of this individual or other inmates; ( ) the health and safety of the custodial officers or employees of, or others at, the correctional institution; ( ) the health and safety of this individual and custodial officers, or other persons responsible for transporting this inmate, or this individual's transfer from one institution, facility or setting to another; ( ) law enforcement on the premises of the correctional institution; or ( ) the administration and maintenance of the safety, security, and good order of the correctional institution. The requested disclosure of protected health information is permitted by the provisions of 45 C.F.R. 164.512(k)(5). Judicial/Administrative The Department of Justice, through its undersigned representative, requests this information for judicial and administrative proceedings. Consistent with 45 C.F.R. 164.512(e), this request is [Insert one of the following alternatives]: A. Pursuant to the order of [a court] [an administrative tribunal], and the only information disclosed is the protected health information expressly authorized by the order [attach copy of order where appropriate]; OR Pursuant to a subpoena, discovery request, or other lawful process, that is not accompanied by a court-order or order of an administrative tribunal, and Reasonable efforts have been made to ensure that the individual whose information is sought has been given notice of the request by way of a good faith attempt to provide written notice to the individual, as shown by the accompanying documentation [attach copy of notice to individual and affidavit of service]; and The notice to the individual included sufficient information about the underlying litigation or proceeding to permit the individual to raise an objection to the [court] [administrative tribunal]; and The time for the individual to raise objections to the [court] [administrative tribunal] has expired, and No objections were filed, or All objections filed by the individual have been resolved by the [court] [administrative tribunal] and the disclosures sought are consistent with such resolution. OR [alternate, if patient has not been given notice]: Reasonable efforts have been made to secure a qualified protective order that meets the requirements set forth in 45 C.F.R.. 164.512(e)(1)(v), and: The parties to the underlying dispute which precipitated this request for protected health information have agreed to a qualified protective order and have presented it to the [court] [administrative tribunal] with jurisdiction over the dispute [attach copy of proposed protective order, if appropriate], OR We have requested a qualified protective order from the [court] [administrative tribunal] with jurisdiction over the dispute [attach copy of proposed protective order, if appropriate]. Minimum Necessary (NOTE: Do not use this language when the request is authorized by the patient or “required by law”, because the “minimum necessary” standard does not apply to disclosures which are required by law.” 65 Fed. Reg. 250, 82530, 82600, 82715); 45 C.F.R. 164.502(b)(2)(v) The information sought in this request is the “minimum necessary to accomplish the intended purpose of the . . . request.” 45 C.F.R. 164.502(b)(2)(v). (See 65 Fed. Reg. 82530 “A covered entity is not required to second guess the scope or purpose of the request...”) Insert Only When Suspension of Notification to Individual is Desired The protected health information concerning the patients [INSERT EITHER PARAGRAPH (i) OR (ii) BELOW] (i) listed on Attachment A, hereto, which your organization disclosed to the Department of Justice on (specify date) in response to a OR (ii) which is disclosed in response to the accompanying (insert type of request, e.g. grand jury subpoena, other subpoena, oral request, other) was requested in furtherance of a federal law enforcement/health oversight (choose one) investigation. An accounting of this disclosure to the individuals concerned would, in this instance, be “reasonably likely to impede the [Department of Justice’s] activities ” 45 C.F.R. Section 164.528(a)(2)(i). Therefore, pursuant to this request and as required by the provisions of 45 C.F.R. Sec. 164.528(a)(2), you must suspend the individual(s)’ right to receive an accounting of this disclosure of protected health information for (months/years). PATIENT AUTHORIZATIONS You are requested to release records pertaining to the individual(s) indicated on the enclosed form(s) titled "Authorization to Release Medical Information." NOTE: (1) Your state laws may contain medical record release requirements other than those set out on this form. (2) If psychotherapy notes are requested, please use the separate authorization for this specific purpose. The regulations provide that an authorization for disclosure of psychotherapy notes may only be combined with another authorization for a use or disclosure of psychotherapy notes. 45 CFR 164.508(b)(3)(ii). PATIENT AUTHORIZATION TO RELEASE MEDICAL INFORMATION TO: PATIENT: RELEASE TO: [Name of person or class of NAME: Representatives of the persons authorized to make United States Attorney’s Office disclosure] BIRTH DATE: or Department of Justice INFORMATION REQUESTED: I request and authorize the above-named person or class of persons to release the information specified below to representatives of the United States Attorney’s Office or the Department of Justice. Any and all records regarding treatment of including but not limited to: (1) Copy of complete chart, progress notes & interview notes, discharge summaries, operative reports, x-ray & all imagery, laboratory tests, pathology tissue, and all diagnostic studies whether in electronic data or other format. (2) Billing records PURPOSE(S) OR NEED FOR WHICH INFORMATION IS TO BE USED: [Include case name or identify administrative claim] CERTIFICATION: I certify that this request has been made voluntarily and that the information given above is accurate to the best of my knowledge. I understand that I may revoke this Authorization at any time, provided that revocation is in writing, except to the extent that action has already been taken in reliance this Authorization. I understand that the doctor, health care provider, or health plan from whom my medical information is requested in this Authorization, may not condition treatment, payment, enrollment or eligibility for benefits on whether I sign this authorization. I understand the potential for the information disclosed pursuant to this Authorization to be subject to redisclosure by the recipient and no longer be protected by the Standards for Privacy of Individually Identifiable Health Information, set forth at 45 CFR Parts 160 and 164. EXPIRATION: Check one: This Authorization will automatically expire upon completion of the litigation [provide case name and number] now pending in U.S. District Court for the District of . This Authorization will automatically expire upon completion of the administrative claim of filed on . This Authorization shall be effective until . OTHER CONDITIONS: x A copy of this Authorization or my signature thereon shall be used with the same effectiveness as an original. x Communications between provider and any representative of the U.S. Attorney's Office/Department of Justice are authorized. SIGNATURE OF PATIENT: OR PERSON AUTHORIZED TO SIGN FOR PATIENT:* __________________ ______________________ MONTH/DAY/YEAR PRINT OR TYPE NAME *Provide basis of Authorization: . PATIENT AUTHORIZATION TO RELEASE PSYCHOTHERAPY INFORMATION TO: PATIENT: RELEASE TO: [Name of person or class of NAME: Representatives of the persons authorized to make United States Attorney’s Office disclosure] BIRTH DATE: or Department of Justice INFORMATION REQUESTED: I request and authorize the above-named person or class of persons to release the information specified below to representatives of the United States Attorney’s Office or the Department of Justice. Any and all records regarding treatment of including but not limited to: 1. All records of psychological or psychiatric testing or treatment, including complete chart, audio and visual recordings, and psychotherapy notes, and 2. Billing records. PURPOSE(S) OR NEED FOR WHICH INFORMATION IS TO BE USED: [Include case name or identify administrative claim] CERTIFICATION: I certify that this request has been made voluntarily and that the information given above is accurate to the best of my knowledge. I understand that I may revoke this Authorization at any time, provided that revocation is in writing, except to the extent that action has already been taken in reliance this Authorization. I understand that the doctor, health care provider, or health plan from whom my medical information is requested in this Authorization, may not condition treatment, payment, enrollment or eligibility for benefits on whether I sign this authorization. I understand the potential for the information disclosed pursuant to this Authorization to be subject to redisclosure by the recipient and no longer be protected by the Standards for Privacy of Individually Identifiable Health Information, set forth at 45 CFR Parts 160 and 164. EXPIRATION: Check one: This Authorization will automatically expire upon completion of the litigation [provide case name and number] now pending in U.S. District Court for the District of . This Authorization will automatically expire upon completion of the administrative claim of filed on . This Authorization shall be effective until . OTHER CONDITIONS: x A copy of this Authorization or my signature thereon shall be used with the same effectiveness as an original. x Communications between provider and any representative of the U.S. Attorney's Office/Department of Justice are authorized. SIGNATURE OF PATIENT: OR PERSON AUTHORIZED TO SIGN FOR PATIENT:* ____________________ _______________________ MONTH/DAY/YEAR PRINT OR TYPE NAME *Provide basis of Authorization: . This Authorization shall be effective until _____________________________. OTHER CONDITIONS: x A copy of this Authorization or my signature thereon shall be used with the same effectiveness as an original. x Communications between provider and any representative of the U.S. Attorney's Office/Department of Justice are authorized. SIGNATURE OF PATIENT: __________________________________________________________________ OR PERSON AUTHORIZED TO SIGN FOR PATIENT:*___________________________________________ __________________ ____________________________________ MONTH/DAY/YEAR PRINT OR TYPE NAME *Provide basis of Authorization:__________________________________________________________. EXHIBIT 26 - DOJ Report (Excel Spreadsheet) (Rev. 16, 11-28-01) Contractor Name Identification Number Date of DOJ Request Nature of Request DOJ Tracking # (if provided) Cost to Fill SBR Y or N Date of SBR Submission Exhibit 27 - National Medicare Fraud Alert (Rev. 10383; Issued: 10-09-2020; Effective: 11-10-2020; Implementation: 11-10-2020) NATIONAL MEDICARE FRAUD ALERT TEMPLATE Distribution of this Fraud Alert is Limited to the Following Audience: CMS regional offices, Unified Program Integrity Contractors, quality improvement organizations, Medicaid Fraud Control units, the Office of Inspector General, the Defense Criminal Investigation Service, the Department of Justice, the Federal Bureau of Investigation, U.S. Attorney offices, U.S. Postal Inspectors, Internal Revenue Service, State Surveyors, State Attorneys General, and the State Medicaid Program Directors SUBJECT: ACTIVITY: SOURCE: DISCOVERY: DETECTION METHODOLOGY: UCM CASE (S): STATUS: CONTACT: THIS ALERT IS PROVIDED FOR EDUCATIONAL AND INFORMATIONAL PURPOSES ONLY. IT IS INTENDED TO ASSIST PARTIES IN OBTAINING ADDITIONAL INFORMATION CONCERNING POTENTIAL FRAUD AND ABUSE AND TO ALERT AFFECTED PARTIES TO THE NATURE OF THE SUSPECTED FRAUD. IT IS NOT INTENDED TO BE USED AS A BASIS FOR DENIAL OF CLAIMS OR ANY ADVERSE ACTION AGAINST ANY PROVIDER OR SUPPLIER. SUCH DECISIONS MUST BE BASED ON FACTS DEVELOPED INDEPENDENT OF THIS ALERT. CMS NMFA DATE Exhibit 28 - Restricted Medicare Fraud Alert (Rev. 10383; Issued: 10-09-2020; Effective: 11-10-2020; Implementation: 11-10-2020) RESTRICTED MEDICARE FRAUD ALERT TEMPLATE THIS ALERT IS CONFIDENTIAL. It is not intended to be used as a basis for the denial of any claim or adverse action against any provider. Such decisions must be based on facts independent of this alert. Distribution is Limited to the Following Audience: CMS regional offices, Unified Program Integrity Contractors, quality improvement organizations, Medicaid Fraud Control units, the Office of Inspector General, the Defense Criminal Investigation Service, the Department of Justice, the Federal Bureau of Investigation, U.S. Attorney offices, U.S. Postal Inspector offices, and the Internal Revenue Service, and the State Medicaid Program Integrity Directors SUBJECT: ACTIVITY: SOURCE: DISCOVERY: DETECTION METHODOLOGY: UCM CASE (S): STATUS: CONTACT: NOTICE: THIS FRAUD ALERT CONTAINS CONFIDENTIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT PURSUANT TO EXEMPTION (b) (2), (b)(5) AND (b)(7)(E) OF THE FOIA. ITS CONTENTS SHOULD NOT BE REPRODUCED OR RELEASED TO ANY OTHER PARTY WITHOUT WRITTEN APPROVAL OF THE BENEFITS INTEGRITY STAFF. DISCLOSURE TO UNAUTHORIZED PERSONS IS PROHIBITED AND MAY BE IN VIOLATION OF THE CRIMINAL PROVISIONS OF THE PRIVACY ACT. THIS ALERT IS PROVIDED FOR EDUCATIONAL AND INFORMATIONAL PURPOSES ONLY. IT IS INTENDED TO ASSIST PARTIES IN OBTAINING ADDITIONAL INFORMATION CONCERNING POTENTIAL FRAUD AND ABUSE AND TO ALERT AFFECTED PARTIES TO THE NATURE OF THE SUSPECTED FRAUD. IT IS NOT INTENDED TO BE USED AS A BASIS FOR DENIAL OF CLAIMS OR ANY ADVERSE ACTION AGAINST ANY PROVIDER OR SUPPLIER. SUCH DECISIONS MUST BE BASED ON FACTS DEVELOPED INDEPENDENT OF THIS ALERT. CMS RMFA DATE Exhibit 29 – Reserve for Future Use (Rev. 220, Issued: 08-24-07, Effective: 09-03-07, Implementation: 09-03-07) Exhibit 30 - Treatment Codes (Rev. 23, 03-18-02) A. Skilled Nursing These represent the services to be performed by the nurse. Services performed by the patient or other person in the home without the teaching or supervision of the nurse are not coded. The following is a further explanation for each service: A1 * Skilled Observation and Assessment (Inc. V.S., Response to Med., etc) Includes all skilled observation and assessment of the patient where the physician determines that the patient's condition is such that a reasonable probability exists that significant changes may occur which require the skills of a licensed nurse to supplement the physician's personal contacts with the patient. (See §3117.4.A.) A2 Foley Insertion Insertion and/or removal of the Foley catheter by nurse. A3 Bladder Instillation Instilling medications into the bladder. A4* Open Wound Care/Dressing Includes irrigation of open, postsurgical wounds, application of medication and/or dressing changes. Does not include decubitus care. Describe dimension of wound (size and amount and type of drainage) on an addendum, when necessary. See A28 for observation uncomplicated surgical incision. A5* Decubitus Care (Partial tissue loss with signs of infection or full thickness tissue loss, etc.) Includes irrigation, application of medication and/or dressing changes to decubitus. The agency describes size (depth and width) and appearance on an addendum when necessary. Use this code only if the decubitus being treated presents the following characteristics: 1 -- Partial tissue loss with signs of infection such as foul odor or purulent drainage; 2 -- Full thickness tissue loss that involves exposure of fat or invasion of other tissue such as muscle or bone. For care of decubitus not meeting this definition, see A29. A6* Venipuncture The HHA specifies the test and frequency to be performed under physician's orders. A7* Restorative Nursing Includes exercises, transfer training, carrying out of restorative program ordered by the physician. This may or may not be established by a physical therapist. This code is not used to describe non-skilled services (e.g., routine range of motion exercises). A8 Post Cataract Care Includes observation, dressings, teaching, etc., of the immediate postoperative cataract patient. (See MIM §3117.4.A.) A9 Bowel/Bladder Training Includes training of patients who have neurological or muscular problems or other conditions where the need for bowel or bladder training is clearly identified. (See MIM §3114.4.E.1.) A10 Chest Physio (Including postural drainage) Includes breathing exercises, postural drainage, chest percussion, conservation techniques, etc. A11 Adm. of Vitamin B- 12 Administration of vitamin B-12 preparation by injection for conditions identified in Medicare guidelines. (See MIM §3117.4.) A12 Adm. Insulin Preparation of insulin syringes for administration by the patient or other person, or the administration by the nurse. A13 Adm. Other IM/Subq Administration of any injection other than vitamin B-12 or insulin ordered by the physician. A14 Adm. IVs/ Clysis Administration of intravenous fluids or clysis or intravenous medications. A15 Teach Ostomy or Ileo conduit care Teaching the patient or other person to care for a colostomy, ileostomy or ileoconduit or nephrostomy. A16 Teach Nasogastric Feeding Teaching the patient or other person to administer nasogastric feedings. Includes teaching care of equipment and preparation of feedings. A17 Reinsertion Nasogastric Includes changing the tube by the nurse. A18 Teach Gastrostomy Feeding Teaching the patient or other person to care for gastrostomy and administer feedings. Includes teaching care of equipment and preparation of feedings. A19 Teach Parenteral Nutrition Teaching the patient and/or family to administer parenteral nutrition. Includes teaching aseptic technique for dressing changes to catheter site. Agency documentation must specify that this service is necessary and does not duplicate other teaching. A20 Teach Care of Trach Teaching the patient or other person to care for a tracheostomy. This includes care of equipment. A21 Adm. Care of Trach Administration of tracheostomy care by the nurse, including changing the tracheostomy tube and care of the equipment. A22 Teach Inhalation Rx. Teaching patient or other person to administer therapy and care for equipment. A23* Adm. Inhalation Rx Administration of inhalation treatment and care of equipment by the nurse. A24 Teach Adm. of Injection Teaching patient or other person to administer an injection. Does not include the administration of the injection by the nurse (see A11, A13) or the teaching/administration of insulin. (See A12, A25.) A25 Teach Diabetic Care Includes all teaching of the diabetic patient (i.e., diet, skin care, administration of insulin, urine testing). A26 Disimpaction/F.U. Enema Includes nursing services associated with removal of an impaction. Enema administration in the absence of an impaction only if a complex condition exists - e.g., immediate postoperative rectal surgery. A27* Other (Spec. Under Orders) Includes any skilled nursing or teaching ordered by the physician and not identified above. The agency specifies what is being taught in Item 21 (Form CMS-485). A28* Wound Care/Dressing – Closed Incision/Suture Line Skilled observation and care of surgical incision/suture line including application of dry sterile dressing. (See A4.) A29* Decubitus Care Includes irrigation, application of medication and/or dressing changes to decubitus/other skin ulcer or lesion, other than that described in A5. The HHA describes size (depth and width) and appearance on the addendum. A30 Teach Care of Any Indwelling Catheter Teaching patient or other person to care for indwelling catheter. A31 Management and Evaluation of Patient Care Plan The complexity of necessary unskilled services require skilled management of a registered nurse to ensure that these services achieve their purpose, and to promote the beneficiary's recovery and medical safety. A32* Teaching and Training (other) (spec. under Orders) Specify under physician orders. * Code which requires a more extensive descriptive narrative for physician’s orders. B. Physical Therapy (PT) These codes represent all services to be performed by the physical therapist. If services are provided by a nurse, they are included under A7. The following is a further explanation of each service: B1 Evaluation Visit(s) made to determine the patient's condition, physical therapy plans and rehabilitation potential; to evaluate the home environment to eliminate structural barriers and to improve safety to increase functional independence (ramps, adaptive wheelchair, bathroom aides). B2 Therapeutic Exercise Exercises designed to restore function. Specific exercise techniques (e.g., Proprioceptive Neuromuscular Facilitation (PNF), Rood, Brunstrom, Codman's, William's) are specified. The exercise treatment is listed in the medical record specific to the patient's condition, manual therapy techniques, which include soft tissue and joint mobilization to reduce joint deformity and increase functional range of motion. B3 Transfer Training To evaluate and instruct safe transfers (bed, bath, toilet, sofa, chair, commode) using appropriate body mechanics, and equipment (sliding board, Hoyer lift, trapeze, bath bench, wheelchair). Instruct patient, family and care-givers in appropriate transfer techniques. B4 Establish or Upgrade Home Program To improve the patient's functional level by instruction to the patient and responsible individuals in exercise which may be used as an adjunct to PT programs. B5 Gait Training Includes gait evaluation and ambulation training of a patient whose ability to walk has been impaired. Gait training is the selection and instruction in use of various assistive devices (orthotic appliances, crutches, walker, cane, etc.). B6 Pulmonary Physical Therapy Includes breathing exercises, postural drainage, etc., for patients with acute or severe pulmonary dysfunction. B7 Ultra Sound Mechanism to produce heat or micro-massage in deep tissues for conditions in which relief of pain, increase in circulation and increase in local metabolic activity are desirable. B8 Electro Therapy Includes treatment for neuromuscular dysfunction and pain through use of electrotherapeutic devices (electromuscular stimulation, Transcutaneous Electrical Nerve Stimulation (TENS), Functional Electrical Stimulation (FES), biofeedback, High Voltage Galvanic Stimulation (HVGS), etc.). B9 Prosthetic Training Includes stump conditioning, (shrinking, shaping, etc.), range of motion, muscle strengthening and gait training with or without the prosthesis and appropriate assistive devices. B10 Fabrication Temporary Devices Includes fabrication of temporary prostheses, braces, splints, and slings. B11 Muscle Re- education Includes therapy designed to restore function due to illness, disease, or surgery affecting neuromuscular function. B12 Management and Evaluation of a Patient Care Plan The complexity of necessary unskilled services require skilled management by a qualified physical therapist to ensure that these services achieve their purpose, and to promote the beneficiary's recovery and medical safety. B13 Reserved B14 Reserved B15 Other (Spec. Under Orders) Includes all PT services not identified above. Specific therapy services are identified under physician's orders (Form CMS-485, Item 21). * Code which requires a more extensive descriptive narrative for physician’s orders. C. Speech Therapy (ST) These codes represent the services to be performed by the speech therapist. The following is a further explanation of each service. C1 Evaluation Visit made to determine the type, severity and prognosis of a communication disorder, whether speech therapy is reasonable and necessary and to establish the goals, treatment plan, and estimated frequency and duration of treatment. C2 Voice Disorders Treatments Procedures and treatment for patients with an absence or impairment of voice caused by neurologic impairment, structural abnormality, or surgical procedures affecting the muscles of voice production. C3 Speech Articulation Disorders Treatments Procedures and treatment for patients with impaired intelligibility (clarity) of speech - usually referred to as anarthria or dysarthria and/or impaired ability to initiate, inhibit, and/or sequence speech sound muscle movements – usually referred to as apraxia/dyspraxia. C4 Dysphagia Treatments Includes procedures designed to facilitate and restore a functional swallow. C5 Language Disorders Treatments Includes procedures and treatment for patients with receptive and/or expressive aphasia/dysphasia, impaired reading comprehension, written language expression, and/or arithmetical processes. C6 Aural Rehabilitation Procedures and treatments designed for patients with communication problems related to impaired hearing acuity. C7 Reserved C8 Non-oral Communications Includes any procedures designed to establish a non-oral or augmentive communication system. C9* Other (Spec. Under Orders) Speech therapy services not included above. Specify service to be rendered under physician's orders (Form CMS-485, Item 21). * Code which requires a more extensive descriptive narrative for physician’s orders. D Occupational Therapy These codes represent the services to be rendered by the occupational therapist. The following is a further explanation of each service: D1 Evaluation Visit made to determine occupational therapy needs of the patient at the home. Includes physical and psychosocial testings, establishment of plan of care, rehabilitation goals, and evaluating the home environment for accessibility and safety and recommending modifications. D2 Independent Living/Daily Living Skills (ADL Training) Refers to the skills and performance of physical cognitive and psychological/emotional self care, work, and play/leisure activities to a level of independence appropriate to age, life-space, and disability. D3 Muscle Re-education Includes therapy designed to restore function lost due to disease or surgical intervention. D4 Reserved D5 Perceptual Motor Training Refers to enhancing skills necessary to interpret sensory information so that the individual can interact normally with the environment. Training designed to enhance perceptual motor function usually involves activities, which stimulate visual and kinesthetic channels to increase awareness of the body and its movement. D6 Fine Motor Coordination Refers to the skills and the performance in fine motor and dexterity activities. D7 Neurodevelop-mental Treatment Refers to enhancing the skills and the performance of movement through eliciting and/or inhibiting stereotyped, patterned, and/or involuntary responses, which are coordinated at subcortical and cortical levels. D8 Sensory Treatment Refers to enhancing the skills and performance in perceiving and differentiating external and internal stimuli such as tactile awareness, stereognosis, kinesthesia, proprioceptive awareness, ocular control, vestibular awareness, auditory awareness, gustatory awareness, and factory awareness necessary to increase function. D9 Orthotics Splinting Refers to the provision of dynamic and static splints, braces, and slings for relieving pain, maintaining joint alignment, protecting joint integrity, improving function, and/or decreasing deformity. D10 Adaptive Equipment (Fabrication and Training) Refers to the provision of special devices that increase independent functions. D11* Other Occupational therapy services not quantified above. * Code which requires a more extensive descriptive narrative for physician’s orders. E. Medical Social Services (MSS) These codes represent the services to be rendered by the medical social service worker. The following is a further explanation of each service: E1 Assessment of Social and Emotional Factors Skilled assessment of social and emotional factors related to the patient's illness, need for care, response to treatment and adjustment to care; followed by care plan development. E2 Counseling for Long- Range Planning and Decision making Assessment of patient's needs for long term care including: Evaluation of home and family situation; enabling patient/family to develop an in-home care system; exploring alternatives to in-home care; or arrangement for placement. E3 Community Resource Planning The promotion of community centered services(s) including education, advocacy, referral and linkage. E4* Short Term Therapy Goal oriented intervention directed toward management of terminal illness; reaction/adjustment to illness; strengthening family/support system; conflict resolution related to chronicity of illness. E5 Reserved E6* Other (Specify Under Orders) Includes other medical social services related to the patient's illness and need for care. Problem resolution associated with high risk indicators endangering patient's mental and physical health including: Abuse/neglect, inadequate food/medical supplies; and high suicide potential. The service to be performed must be written under doctor's orders (Form CMS-485, Item 21). * Code which requires a more extensive descriptive narrative for physician’s orders. F. Home Health Aide These codes represent the services to be rendered by the home health aide. Specific personal care services to be provided by the home health aide must be determined by a registered professional nurse. Services are given under the supervision of the nurse, and if appropriate, a physical, speech or occupational therapist. The following is a further explanation of each service: F1 Tub/Shower Bath Assistance with tub or shower bathing. F2 Partial/Complete Bed Bath Bathing or assisting the patient with bed bath. F3 Reserved F4 Personal Care Includes shaving of patient or shampooing the hair. F5 Reserved F6 Catheter Care Care of catheter site and/or irrigations under nursing supervision. F7 Reserved F8 Assist with Ambulation Assisting the patient with ambulation as determined necessary by the nurse care plan. F9 Reserved F10 Exercises Assisting the patient with exercises in accordance with the plan of care. F11 Prepare Meal May be furnished by the aide during a visit for personal care. F12 Grocery Shop May be furnished as an adjunct to a visit for personal care to meet the patient's nutritional needs in order to prevent or postpone the patient's institutionalization. F13 Wash Clothes This service may be provided as it relates to the comfort and cleanliness of the patient and the immediate environment. F14 Housekeeping Household services incidental to care and which do not substantially increase the time spent by the home health aide. F15* Other (Specify Under Orders) Includes other home health aide services in accordance with determination made by a registered professional nurse. Specified in Form CMS-485, Item 21. • Code which requires a more extensive descriptive narrative for physician’s orders. • Exhibit 31 - Form CMS-485, Home Health Certification and Plan of Care (Rev. 23, 03-18-02) View Form CMS-485 (PDF, 10 KB) Exhibit 32 - Harkin Grantee Winframe Database Access and Operation Instructions - (Rev. 32, 10-25-02) View the Harkin Grantee Winframe Database Access and Operation Instructions (PDF, 298 KB) Exhibit 33 - Harkin Grantee Model Form -- (Rev. 32, 10-25-02) View the Harkin Grantee Model Form (PDF, 74.6 KB) HARKIN PROJECT FRAUD AND ABUSE COMPLAINT REFERRAL FORM DATE:  From: (Your Name)___________________________ Organization: ____________________ Address:_____________________ City:_________________ State:__________ Zip:________ Phone: (With Area Code) Fax # E-Mail (If Applicable) Beneficiary Name: Medicare #: Medicaid #: Date of Birth: Address: Phone #: (With Area Code) City: State: Zip: Name of Complainant (If Different From Beneficiary): Address: Phone #: (With Area Code) City: State: Zip: Complaint Against: (Name of facility, provider, physician, lab, supplier, etc.) Claim # (If appropriate) Date(s) of Service: Business Address: Phone: (With Area Code) Provider Number: City: State: Zip: Description of Complaint: Please describe your complaint. If known, include procedure code and/or description of service, amounts billed, amount you paid, etc. You may continue on the next page if you need more room. If you feel you were billed for services or supplies that were not provided, continue on with the non-rendered service section below. Non-rendered Services Section: Did you see any provider that day? ______________ If yes, who? (Physician’s Assistant, Nurse, Lab, X-ray Technician) Was the service(s) provided on another day? _______________ If yes, when? _________ Have you ever seen the provider listed? ___________________ If yes, when? _________ Have you contacted the provider/supplier regarding this billing? ______ Yes _____ No If yes, to whom did you speak and what was the result of the conversation? I authorize ________________________________ and (insert name of project)_ to discuss my complaint for the purpose of investigating possible fraud or abuse. I understand that, except for action already taken, I may revoke this authorization at any time. I also understand that a photocopy of this authorization has the same effect as the original. I further understand that the parties named above will not disclose this information to anyone else without my consent. This authorization expires one (1) year from the date on which it is signed. ________________________________ ________________ Signature Date If receiving a telephone complaint write “telephone complaint” on the signature line Important: Please attach the appropriate Medicare and/or Medicaid Explanation of Benefits relating to this incident. Also attach any other information you feel may be important to this complaint. When completed mail to: (insert name of project) Exhibit 34 – Reserved for Future Use (Rev. 548, Issued: 10-17-14; Effective Date: 11-18-14, Implementation Date: 11-18-14) Exhibit 35 – Memorandum of Understanding (MOU) with Law Enforcement DEPARTMENT OF JUSTICE ACCESS TO MEDICARE CONTRACTOR INFORMATION Combating Medicare fraud is a goal shared by the Department of Justice (DOJ), Department of Health and Human Services Office of the Inspector General (OIG), and the Health Care Financing (HCFA). Investigating and prosecuting such cases typically requires access to information and documents from Medicare contractors. To ensure that law enforcement’s need for this information is met consistent with Medicare contractors’ other responsibilities, DOJ, OIG, and HCFA agree to the following procedures: 1. DOJ can request in writing information and documents related to an ongoing civil or criminal health care fraud investigation or prosecution directly from a Medicare contractor. DOJ includes personnel at the Federal Bureau of Investigation (FBI), United States Attorneys Offices, and the Department of Justice in Washington, D.C., including but not limited to the Criminal Division and Civil Division. 2. When DOJ requests information from a Medicare contractor, it must notify the Regional OIG in writing. OIG approval is not necessary for DOJ requests for information from a Medicare contractor. OIG notification is intended to prevent duplication in investigative efforts. 3. HCFA approval is not necessary before a Medicare contractor can provide information requested to DOJ. 4. It is presumed that a Medicare contractor will furnish DOJ officials with information and documents related to a civil or criminal health care fraud investigation or prosecution in a timely fashion. However, if a Medicare contractor objects to the request on the basis that it is unduly burdensome in terms of the volume of information requested, the timing of the request, or the format in which DOJ seeks the information, the Medicare contractor may take the following steps: a. Contact the requesting DOJ official to explain the basis of the objection. All parties agree to make good faith efforts to reach a resolution that accommodates DOJ’s legitimate law enforcement needs and the Medicare contractor’s budgetary constraints or other needs. Legitimate requests include but are not limited to requests for the following documents: (1) information contained on claim forms and other records maintained on individual providers or suppliers; (2) billing procedure updates and other Medicare publications furnished to providers or suppliers; (3) contractor correspondence to and from providers/suppliers; (4) billing history of beneficiaries; (5) analysis performed by Fraud and Abuse Units; (6) data analysis routinely done by Medicare contractors such as utilization reviews. DOJ recognizes that general data analysis is typically the prerogative of the Medicare contractor and HCFA and, therefore, agrees to limit requests for data analysis not otherwise performed by the Medicare contractor. HCFA recognizes that OIG and DOJ may have legitimate law enforcement needs for data analysis in ongoing investigations and proceedings. Where DOJ requests data analysis not otherwise performed by the contractor, DOJ should discuss the request with the Medicare contractor to explain the need for such analysis and to determine whether there is an alternative format for a contractor to provide the information. b. Where the FBI has sought the information, the FBI may involve in the resolution a representative of the United States Attorney’s Office, DOJ’s Criminal Division or Civil Division. c. If the Medicare contractor and the requesting DOJ official cannot reach an accommodation, then they may seek the intervention of HCFA’s Associate Regional Administrator. It is anticipated that such an appeal will be a rare occurrence prevented by reasonable requests and timely and comprehensive responses. 5. Periodic meetings between DOJ, OIG, HCFA regional officials, and the Medicare contractors should be held at the local levels. Similar meetings between DOJ, OIG, and HCFA should be held at the national levels. Such meetings offer an opportunity to discuss trends in fraudulent practices; to devise possible solutions to stopping ongoing fraud; to report the status of DOJ health care fraud cases—consistent with DOJ’s enforcement needs and limitations on permissible disclosure of such information; to resolve problems, if any, concerning requests for information; and generally, to foster cooperation among law enforcement, HCFA, and Medicare contractors. 6. DOJ, OIG, and HCFA agree to conduct training to familiarize their respective personnel on the activities and needs of the others. 7. DOJ will handle the information and documents obtained from Medicare contractors consistent with existing statutory and regulatory provisions protecting confidentiality of patient records including, but not limited to, the Privacy Act of 1974. 8. Contractors requiring further instructions or clarification regarding any aspect of this policy, including the application of any statute or regulation, may contact the appropriate Associate Regional Administrator. This policy will be revisited six months from the date of its adoption. ______________/s/_____________ ___________________/s/____ GERALD M. STERN JUNE GIBBS BROWN Special Counsel for Health Care Fraud Inspector General Department of Justice Department of Health and Human Services ______________/s/_____________ BRUCE VLADECK Administrator Health Care Financing Administration ______________4/29/94_________ DATE