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1 AHLA Medicare & Medicaid Institute Conditions of Participation as a basis for Overpayment, Mandatory Report/ Refund, and False Claims Act Liability Timothy P. Blanchard Robert A. Hussar James G. Sheehan. Advanced Session Agenda Background Conditions of Participation Conditions of Payment Case Law Provider Certifications New Developments, Threats and Opportunities Case Studies 1
2 What are COPs? The COPs define specific quality standards that providers shall meet to participate in the Medicare program.... 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. Medicare Program Integrity Manual, CMS-Pub , Chapter 3, 3.1A (emphasis added). Where are COPs? Medicare Regulations Conditions of Participation, Conditions for Coverage, Conditions of Certification Medicare Statute 42 U.S.C. 1320c-5(a)(6) Economically and only when medically necessary; Of quality meeting professionally-recognized standards; Supported by evidence of medical necessity/quality PPACA Condition of Enrollment State law licensing and payment requirements Medicaid Statute and Regulations 2
3 42 CFR Basis and scope. (a)(5) Section 1905(a) of the Act provides that medical assistance (Medicaid) payments may be applied to various hospital services. Regulations interpreting those provisions specify that hospitals receiving payment under Medicaid must meet the requirements for participation in Medicare.... (b) Except as provided in subpart A of part 488 of this chapter, the provisions of this part serve as the basis of survey activities for the purpose of determining whether a hospital qualifies for a provider agreement under Medicare and Medicaid. What are Conditions of Payment? Submission of a claim Medicare payment shall not be made... If excluded from coverage, 42 USC 1395y Unless documented as requirements, 42 USC 1395l(e) If prohibited under Stark self-referral, 42 USC 1395nn Implications of Provider Certifications Evolving Government Positions and Policy 3
4 J1 U.S. ex rel. Mikes v. Straus (2001) Noncompliance Basis for FCA Liability [A] claim is false only if the Government or other customer would not pay the claim if the facts about the misconduct alleged to have occurred were known. [I]t would be anomalous to find liability when the alleged noncompliance would not have influenced the government's decision to pay. BUT-FERA 2009 Amendments (4) the term material means having a natural tendency to influence, or be capable of influencing, the payment or receipt of money or property. ; U.S. ex rel. Mikes v. Straus (2001) COPs vs. Conditions of Payment Statutory Language and Statutory Design Established Administrative Process Remedies other than payment denial Opportunities to Cure (e.g., POCs, CAPs) 4
5 Slide 7 J1 Jim, 3/25/2012
6 CMS Claim-Form Certifications CMS-1500 (and electronic X12N Health Care Claim: Professional (837)) I certify that the services shown on this form were medically indicated and necessary for the health of the patient and were personally furnished by me or were furnished incident to my professional service by my employee under my immediate personal supervision, except as otherwise expressly permitted by Medicare or CHAMPUS regulations. See also CMS-1450 (i.e., UB-04) Mikes Certification Analytical Framework Factually false incorrect description of goods/services provided or claim for goods/services never provided Legally false compliance with a statute or regulation as a condition of governmental payment. Express false certification specific representations in the claim form certification Implied false certification Appropriate only when underlying statute or regulation expressly states that provider must comply in order to be paid and defendant billed knowing that payment expressly was precluded because of noncompliance by the defendant. 5
7 U.S. ex rel. Hutcheson v. Blackstone (2011) The First Circuit Rejected: analytical framework from Mikes District Court holding that conditions of payment cannot be hidden in an enrollment form Conclusion that conditions of payment must be specifically stated in statute or regulations Court looks to Provider Agreement, CMS 855 Form and Cost Report Certifications Raises exposure under PPACA overpayment refund rule (acts of third parties) CMS-855A Certification I agree to abide by the Medicare laws, regulations and program instructions that apply to this provider.... I understand that payment of a claim by Medicare is conditioned upon the claim and the underlying transaction complying with such laws, regulations, and program instructions (including, but not limited to, the Federal anti-kickback statute and the Stark law), and on the provider s compliance with all applicable conditions of participation in Medicare. (Emphasis added.) 6
8 CMS Cost Reports Worksheet S MISREPRESENTATION OR FALSIFICATION OF ANY INFORMATION CONTAINED IN THIS COST REPORT MAY BE PUNISHABLE BY CRIMINAL, CIVIL AND ADMINISTRATIVE ACTION, FINE AND/OR IMPRISONMENT UNDER FEDERAL LAW. FURTHERMORE, IF SERVICES IDENTIFIED IN THIS REPORT WERE PROVIDED OR PROCURED THROUGH THE PAYMENT DIRECTLY OR INDIRECTLY OF A KICKBACK OR WERE OTHERWISE ILLEGAL, CRIMINAL, CIVIL AND ADMINISTRATIVE ACTION, FINES AND/OR IMPRISONMENT MAY RESULT. (Emphasis added.) Cost Report Certification by Provider I HEREBY CERTIFY that I have read the above statement and that I have examined the accompanying... cost report and the Balance Sheet and Statement of Revenue and Expenses prepared by [Provider] for the cost reporting period beginning [_] and ending [_] and to the best of my knowledge and belief, it is a true, correct and complete statement prepared from the books and records of the provider in accordance with applicable instructions, except as noted. I further certify that I am familiar with the laws and regulations regarding the provision of health care services, and that the health care services identified in this cost report were provided in compliance with such laws and regulations. 7
9 OIG 2012 WORKPLAN CONDITIONS OF PAYMENT We will review home health agencies OASIS data to identify payments for episodes for which OASIS data were not submitted or for which the billing code on the claim is inconsistent with OASIS data. Assumption-no OASIS data, no payment OIG 2012 WORKPLAN Federal regulations provide that beneficiaries receiving home health services must be homebound; need intermittent skilled nursing care, physical or speech therapy, or occupational therapy; be under the care of a physician; and be under a plan of care that has been established and periodically reviewed by a physician. (42 CFR ) 8
10 MEDICAID-CONDITIONS OF PAYMENT WORKPLAN We will review Medicaid payments for personal care services (PCS) to determine whether States have appropriately claimed the FFP. PCS must be authorized by a physician or (at the option of the State) otherwise authorized in accordance with a plan of treatment, must be provided by someone who is qualified to render such services and who is not a member of the individual s family, and must be furnished in a home or other location. Medicaid Personal Care Claims in New Jersey Pursuant to NJAC 10:60-1.2, personal care assistants must successfully complete a minimum of 12 hours of inservice education per year offered by the provider. For 13 of the 100 claims in our sample, there was no evidence that the personal care assistant received the minimum required inservice education during the calendar year in which the service was provided or during the preceding 12 months. 13 claims projected to universe; each claim, on average, projected to $400,000 federal share recovery (A )
11 Audit of Ambercare Home Health New Mexico law requires provider agencies to provide all attendants a minimum of 12 hours of training per year; and requires provider agencies to maintain in attendants files copies of documentation that all training had been completed. For 6 of the 100 sampled claims, Ambercare could not provide evidence that the attendants had completed 12 hours of annual training for the calendar year of the dates of service. OIG/HHS disallowed the 6 claims for services; projected to universe (A ) Audit of Ambercare Home Health New Mexico law requires provider agencies to maintain in attendant files copies of all CPR certifications and to ensure that these certifications are current.1 For 1 of the 100 sampled claims, Ambercare could not provide evidence that the attendant was certified in CPR on the dates of service. OIG/HHS disallowed 1 claim for services;error projected to universe; Because of sampling and projection, each $250 claim resulted in recovery of about $35,000 (A )
12 Continuing Day Treatment Providers in NY OIG REJECTS REGULATORY/PAYMENT DISTINCTION NY State argument : OMH maintains various means of monitoring and enforcing provider compliance with program standards. These include requiring providers to submit a plan of correction addressing program deficiencies that have been identified by OMH; increasing the frequency of program inspections; the imposition of fines; and the limitation, and suspension or revocation of the provider's license. -$84 million overpayment determination OIG AUDIT A ( ) PPACA Conditions of Enrollment On or after the date of implementation determined by the Secretary under subparagraph (C), a provider of medical or other items or services or supplier within a particular industry sector or category shall, as a condition of enrollment in the program under this title, title XIX, or title XXI, establish a compliance program that contains the core elements established under subparagraph (B) with respect to that provider or supplier and industry or category. 42 USC 1395cc(j)(8)(A) See PPACA
13 Mandatory Compliance PPACA 6102(b) A SNF... shall have in operation a compliance and ethics program that has been reasonably designed, implemented and enforced so that it generally will be effective in preventing and detecting criminal, civil, and administrative violations AND in promoting quality of care consistent with regulations developed by the Secretary, working jointly with the HHS OIG. ACOs 42 CFR (3) Annual certification. An individual with the legal authority to bind the ACO must certify to the best of his or her knowledge, information, and belief (i) That the ACO, its ACO participants, its ACO providers/ suppliers, and other individuals or entities performing functions or services related to ACO activities are in compliance with program requirements; and (ii) The accuracy, completeness, and truthfulness of all data and information that are generated or submitted 12
14 42 CFR COP: Governing body The hospital must have an effective governing body legally responsible for the conduct of the hospital as an institution. 13
15 Suggestions for building and measuring a compliance program for effectiveness Measure Outcomes Measures of effectiveness: Self-reporting/hotlines Frequency of audit issues recurring Exclusion lists Deceased beneficiary billing Quality of care Process Compliance connections to governing board and management Working policies and procedures Systems identifying risk areas, errors, PoC and monitoring Build Structure Compliance plan document Compliance officer Compliance committees Policies and procedures systems in place to address compliance risk areas 14
16 Case Study 1 State law requires that every nursing home aide be a CNA, that each have 30 hours of training prior to initial patient contact, and that they have 12 hours of continuing education each year. Services cannot be provided by aides unless they meet these requirements. Nursing home has staff who provided nursing home services but failed to comply with the 30 hour rule or the 12 hour rule. Case Study 2 Home Health agency must be licensed under state law to provide services to any patient; Licensing requirements include: Certified Home Health Aides Licensed physician agency oversight Written plans of care for each patient Agency uses non-certified Home Health Aides for Medicare and Medicaid services; lacked licensed physician for six months 15
17 Questions Timothy P. Blanchard Blanchard Manning LLP Box 490, Orcas WA Robert A. Hussar Manatt, Phelps & Phillips, LLP 30 S Pearl St, 12th Floor Albany, NY (518) Direct rhussar@manatt.com James G. Sheehan Chief Integrity Officer/ Executive Deputy Commissioner New York City Human Resources Administration 250 Church Street, 6th Floor New York, NY Office: (212) sheehanj@hra.nyc.gov 16
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