AHLA. M. Surviving an Overpayment Demand Resulting from an Extrapolation of a High Error Rate in an Extremely Small Probe Sample

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1 AHLA M. Surviving an Overpayment Demand Resulting from an Extrapolation of a High Error Rate in an Extremely Small Probe Sample Catherine Gill LW Consulting, Inc. Harrisburg, PA Donna J. Senft Baker Donelson Bearman Caldwell & Berkowitz Baltimore, MD Long Term Care and the Law February 22-24, 2017

2 SURVIVING AN OVERPAYMENT DEMAND Extrapolation from Small Probe Sample Donna J. Senft, Shareholder BakerOber Health Law Catherine Gill, MS, PT, MHA LW Consulting, Inc. Introduction Benefit of coordinated approach -- provider, consultant and attorney team. Distinguishing conditions of participation versus payment implications of Escobar case. Curing documentation deficiencies when covered services were delivered. Considerations during appeals process -- repayment or recoupment, preserving evidence, factual and legal arguments. 2 1

3 The Team Members Role of Team Members Provider gather and preserve patient records, interview staff to gather additional facts Provide copies of records submitted in response to original record request. If outside providers any records in company s software, in soft charts. Attorney assist in selecting consultant, engage consultant, identify and make legal arguments. Consultant identify record set, subset to support claim and missing records, make factual arguments. 3 Selecting a Consultant Does the company have the right clinical expertise? Identify need for nurse reviewers and therapist (PT, OT and/or SLP) reviewers. Identify need for certified coders. Does the company have a statistician? Can the statistician distill the analysis into language understood by the attorney making the legal arguments? Would the statistician make a good expert witness? Is the company recognized by a governmental agency as having the qualifications to perform an appropriate and independent review? 4 2

4 Selecting a Consultant For example: is the consultant qualified to serve as an Independent Review Organization ( IRO ) for the OIG to review claims under Corporate Integrity Agreement? Government Auditing Standards, 2011 Revision, GAO G (referred to as the GAO Yellow Book ). OIG has incorporated GAO standards to determine if an organization has the qualifications to perform the required review and provide the necessary certification regarding objectivity and independence. See OIG Guidance on IRO Independence and Objectivity. 5 Selecting a Consultant Does the company understand: Correct rules to apply applicable regulations, CMS manual provisions, NCDs/LCDs, other guidance? The distinctions between conditions for payment / conditions or requirements for coverage and conditions of participation (COP)? Is the company able to issue spot legal issues? Has the company performed similar work under an attorney-client privileged engagement? 6 3

5 Engaging the Consultant Engagement Letter: Terms of the engagement. Detailed consultant scope and fee schedule. Incorporate a BAA or reference previously executed BAA. Signed by all three parties attorney, provider and consultant. Initial Conference Call to Discuss: Attorney-client privilege matters. Respective role of each party. Communication flow. 7 Role of the Consultant Identify the deliverables from the Consultant: Claim line item analysis. Identification of missing, incomplete or illegible patient records. Notifying attorney of potential legal arguments. Assistance with preparing declarations. Preparation of documents for appeal: Claim spreadsheet possibly with rebuttal comments. Development of supporting statements. Patient records entire set to support the claim and key subset to refute the reviewer s findings. 8 4

6 Role of the Attorney in Preparing Appeal Determine if the correct review standards were applied or not: Review the regulations, CMS manual provisions, NCD and/or LCD or other reference materials cited by the reviewers are these the applicable rules? If not, identify and ensure consultant will be applying the correct rules and will cite to the correct rules when preparing appeal documents. Determine if an identified error is a condition for payment, coverage requirement, or COP. Historic analysis clearer distinction. Escobar decision muddied the waters. 9 Role of the Attorney in Preparing Appeal Payment / Coverage Requirement vs. COP CMS s guidance to assist Medicare contractors that review medical records and Medicare claims to identify errors and take appropriate corrective actions: If during a review, any contractor believes that a provider does not comply with conditions of participation, the reviewer shall not deny payment solely for this reason. Instead, the contractor shall notify the RO and the applicable State survey agency. MPIM, CMS Pub , Ch A. 10 5

7 Role of the Attorney in Preparing Appeal Payment / Coverage Requirement vs. COP Historically, any number of cases refused to find FCA liability if error was a result of non-compliance with COP. Escobar Court identified two conditions that needed to be satisfied: The claim does not merely request payment, but also makes specific representations about the goods or services provided; and The failure to disclose noncompliance with material statutory, regulatory, or contractual requirements makes those representations misleading half-truths. 11 Role of the Attorney in Preparing Appeal Drafting the legal arguments: Develop all legal arguments to be included in the Request for Redetermination or Request for Reconsideration and enclose copies of cited reference materials that may not be readily available to the appeal s reviewers. Provide a short narrative for each legal issue for the consultant to include with the factual arguments on the claims spreadsheet or in a supporting statement. Ensure a complete evidentiary record applicable records enclosed, declaration versus attestation, all required information on appeal documents. 12 6

8 Role of the Attorney in Preparing Appeal Attestation Statement: Must be signed and dated by the author of the medical record entry and contain sufficient info to identify the beneficiary. MACs are NOT to consider an attestation statement where no associated medical record entry exists. Not an accepted form of evidence in administrative or judicial proceeding. Declaration: Mechanism, accepted in an administrative or court proceeding, to place evidence into the record. Mechanism to supplement the record (even without an associated entry) by having the individual, based on personal knowledge and recollection, provide the information in a sworn declaration. 13 Considerations Related to Filing Appeal Determine whether to repay, allow recoupment or avoid recoupment: Initial decision needs to be made quickly potential to change the focus of the first stage of appeal. Revisit the decision after the second level of appeal under the current rules recoupment can only be avoided at the first two levels of appeal. Implications of interest accrual: 42 C.F.R accrues from the date of the overpayment demand notice for each full 30-day period but waived if full payment in the initial 30-day period % in 1 st quarter of 2017, but compounded monthly. 14 7

9 Considerations Related to Filing Appeal Repayment of alleged overpayment: With current interest rates, may be benefit to borrowing money and repaying in full to avoid interest accrual. Extended repayment schedule: if immediate repayment, within the 30-day period, would cause a financial hardship. Hardship: extend payments for up to 6 months. Extreme Hardship: extend for 36 to 60 months. NOTE: When repaid in installments, or recouped by withholding several payments due the provider, each payment or recoupment is first applied to offset accrued interest, then applied to the principal. Interest continues to accrue on the remaining unpaid balance. 15 Considerations Related to Filing Appeal Avoid Recoupment : Section 935 of the Medicare Modernization Act of 2003 (MMA) required CMS to modify the appeal process to avoid recoupment until after the issuance of a Reconsideration Decision. 42 U.S.C. 1395ddd(f)(2)(A). Request for Redetermination (1 st level appeal): file within 30 days to avoid recoupment. MAC can begin recoupment no earlier than 41 days from date of overpayment demand. 42 C.F.R (d). If later filed, MAC is to stop recoupment once appeal is validated but may not refund already recouped payments. 16 8

10 Considerations Related to Filing Appeal Avoid Recoupment : Request for Reconsideration (2 nd level appeal): file within 60 days to avoid recoupment. If recoupment previously stopped, MAC can initiate or resume recoupment on the 60th calendar day after the date of the Redetermination Decision. 42 C.F.R (e)(ii). Limitation on Recoupment (935) for Provider, Physicians, and Suppliers Overpayment, MLNMatters MM Considerations Related to Extrapolation Appropriateness of use of SVRS and extrapolation: Situations exist in which the facts and circumstances are so varied that statistical sampling is not appropriate. Vista Hospice Care FCA case where the court refused to allow the relator to establish liability by use of extrapolation to determine extent of alleged false claims. Court provided overview of the science of statistics. Cited to other cases where courts refused to allow extrapolation based on a non-representative sample. Case involved hospice eligibility court focused on different patients, medical conditions, caregivers, facilities, time periods, and physicians. U.S. ex rel. Wall v. Vista Hospice Care, Inc., (N.D. Tex.). 18 9

11 Considerations Related to Extrapolation Extrapolation Limitations by MMA of 2003: A Medicare contractor may not use extrapolation to determine overpayment amounts to be recovered by recoupment, offset, or otherwise unless the Secretary determines that (A) there is a sustained or high level of payment error, or (B) documented educational intervention has failed to correct the payment error. 42 U.S.C. 1395ddd(f)(3). The statute further provides there is no administrative or judicial review... of determinations by the Secretary of sustained or high levels of payment errors. 19 Understanding the Key Components of the Audit Process PREPARATION SAMPLING RECORD REQUEST AUDIT APPEAL 20 10

12 Preparation Define of key issues and scope Identify audit team and resources Identify audit elements

13 Grid Sample 23 Preparation Define of key issues and scope Identify audit team and resources Identify audit elements Identify required record elements Develop engagement letter 24 12

14 Engagement Letter Define the audit unit Define the number of audits Define the scope of the audit Define the documents required Define access method Define deliverables Define payment 25 What Drives Cost? EMR vs downloaded documents Badly organized documents Missing documents 26 13

15 Preparation Define of key issues and scope Identify audit team and resources Identify audit elements Identify required record elements Develop engagement letter Discuss HIPAA-compliant & privileged practices Provide secure portal vs system access 27 Sampling Obtain claims universe Data integrity review Sample selection using RAT-STATS 28 14

16 Record Request Provide sample selection Provide list of record elements or Obtain access to system 29 Audit Auditor education Audit Quality Review Supplemental Information Audit Initial Issue Identification Quality Review Attorney/Client Review Final Audit Determination 30 15

17 Appeal Identify key issues and supportive documentation Develop supportive statements

18 Reference Sources for Supportive Statements CMS Manuals Professional Association Standards Medical references/journal articles 33 Analysis of the Statistical Sampling Design Define the provider of interest Define the period to be reviewed Define the sample universe, sampling frame and sampling unit Define the sampling plan If used for extrapolation, a probably sample must be selected 34 17

19 Analysis of the Application of the Statistical Sampling Methodology Is there clear, detailed documentation on what was done? Was the randomization, stratification and selection methodology appropriate? Was the designed followed? Were there any errors in the formulas used? Can it be replicated? 35 Contact Information Donna J. Senft BakerOber Health Law Catherine Gill, MS, PT, MHA LW Consulting, Inc

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