Linda Fotheringill, Co-Founder and Partner, Fotheringill & Wade, Baltimore

Transcription

1 Presenting a live 90-minute webinar with interactive Q&A Medical Necessity Documentation, Challenges and Defense Complying With Federal and State Regulatory Requirements, Demonstrating Reasonable and Necessary Healthcare Services WEDNESDAY, MARCH 22, pm Eastern 12pm Central 11am Mountain 10am Pacific Today s faculty features: Linda Fotheringill, Co-Founder and Partner, Fotheringill & Wade, Baltimore Sarah Mendiola, Esq., Fotheringill & Wade, Baltimore The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions ed to registrants for additional information. If you have any questions, please contact Customer Service at ext. 10.

2 Tips for Optimal Quality FOR LIVE EVENT ONLY Sound Quality If you are listening via your computer speakers, please note that the quality of your sound will vary depending on the speed and quality of your internet connection. If the sound quality is not satisfactory, you may listen via the phone: dial and enter your PIN when prompted. Otherwise, please send us a chat or sound@straffordpub.com immediately so we can address the problem. If you dialed in and have any difficulties during the call, press *0 for assistance. Viewing Quality To maximize your screen, press the F11 key on your keyboard. To exit full screen, press the F11 key again.

3 Continuing Education Credits FOR LIVE EVENT ONLY In order for us to process your continuing education credit, you must confirm your participation in this webinar by completing and submitting the Attendance Affirmation/Evaluation after the webinar. A link to the Attendance Affirmation/Evaluation will be in the thank you that you will receive immediately following the program. For additional information about continuing education, call us at ext. 35.

4 Program Materials FOR LIVE EVENT ONLY If you have not printed the conference materials for this program, please complete the following steps: Click on the ^ symbol next to Conference Materials in the middle of the lefthand column on your screen. Click on the tab labeled Handouts that appears, and there you will see a PDF of the slides for today's program. Double click on the PDF and a separate page will open. Print the slides by clicking on the printer icon.

5 Complying With Federal and State Regulatory Requirements, Demonstrating Reasonable and Necessary Healthcare Services Presented by: Linda Fotheringill, Esq. Sarah Mendiola, Esq., LPN, CPC March 22, 2017 Strafford Webinar Panel

6 Fotheringill & Wade, LLC. Presenters Linda Fotheringill, Esq. Co-Founder and Principal Sarah Mendiola, Esq., LPN, CPC Senior Attorney Director of Clinical Services 6

7 Overview Appropriate Documentation of Medical Necessity Identifying Risks Understanding government s legal theories in medical necessity investigations Recent Cases, Legal Actions and Settlements Defenses available to providers Best Practices for Ensuring Compliance with Regulations Ensuring appropriate documentation 7

8 Medical Necessity 8

9 How is Medical Necessity Defined? Federal/Medicare SSA Section 1862 (a) (1) (A) Notwithstanding any other provision of this title, no payment may be made under part A or part B for any expenses incurred for items or services (1)(A) which, except for items and services described in a succeeding subparagraph, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member State Definitions vary from state to state, but are typically similar regarding current care standards and costeffectiveness. Subjective Example - Georgia care based upon generally accepted medical practices in light of conditions at the time of treatment 9

10 Federal/Medicare: Medical Necessity Layers Social Security Act Federal Register IPPS and OPPS Proposed & Final Rules Code of Federal Regulations Medicare Manuals CMS' program issuances, day-to-day operating instructions, policies, and procedures that are based on statutes, regulations, guidelines, models, and directives. National and Local Coverage Determinations Medicare Learning Network MLN Matters Articles 10

11 Federal/Medicare: Medical Necessity Layers, cont. CMS presumes a healthcare provider s knowledge of every word of every statute, rule, NCD/LCD, manual, transmittal, etc. Administrative Law Judge comment in an Unfavorable ALJ Decision: The Provider was unquestionably aware of the CMS regulations, manuals and rulings, CMS bulletins, past unfavorable CMS contractor actions and the lack of substantiating medical records. See 42 CFR Section (e) (knowledge presumed from experience and constructive notice of CMS publications). 11

12 Determining Medicare Medical Necessity Example: Total Knee Replacement 12

13 Can the Entire Inpatient Claim be Denied as Not Medically Necessary? When a procedure was not medically necessary, the contractor shall follow these guidelines: If the admission was for the sole purpose of the performance of the non-covered procedure, and the beneficiary never developed the need for a covered level of service, deny the admission; If the admission was appropriate, and not for the sole purpose of performing the procedure, deny the procedure (i.e., remove from the DRG calculation), but approve the admission (MPIM, Ch. 6, Section 6.5.4) 13

14 Example Medical Record Documentation: Total Knee Replacement Mr. Smith is a 69 y/o male with a hx of osteoarthritis of the right knee, becoming increasingly severe. His pain has been worsening over the last 6 years to the point that he is no longer able to climb the stairs in his home. NSAIDs have not been effective. He has participated in a therapy program for the last 2 months and is not exhibiting any improvement. The pt has received a series of injections to the knee over the past 6 years which were helpful at first, but have not been helpful as of late. Risks and benefits to TKA discussed, patient voiced understanding. 14

15 Federal/Medicare: Medical Necessity Layers SSA? reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member Federal Register/Final Rule? Consider that this is an inpatient only procedure according to the CMS-1656-FC-2017 OPPS FR, Addendum E. CFR? Medicare Manuals? NCD/LCD? MLN Matters Article? 15

16 16

17 MLN Matters Number: SE 1236 Document Medical Necessity to Avoid Denial of Claims CMS recognizes that joint replacement surgery is reserved for patients whose symptoms have not responded to other treatments. To avoid denial of claims for major joint replacement surgery, the medical records should contain enough detailed information to support the determination that major joint replacement surgery was reasonable and necessary for the patient. Progress notes consisting of only conclusive statements should be avoided. Consequently, the medical record must specifically document a complete description of the patients historical and clinical findings. Examples of such information may include: History: Description of the pain (onset, duration, character, aggravating, and relieving factors); Limitation of Activities of Daily Living (ADLs) specify; Safety issues (e.g. falls); Contraindications to non-surgical treatments; Listing and description of failed non-surgical treatments such as: Trial of medications (for example, NSAIDs); Weight loss; Physical therapy; Intra-articular injections; Braces, orthotics or assistive devices. Physical Examination: Deformity; Range of motion; Crepitus; Effusions; Tenderness; Gait description (with/without mobility aides). Investigations: Results of applicable investigations (e.g. plain radiographs). Clinical Judgment: Reasons for deviating from a stepped-care approach. 17

18 MLN Matters Number: SE 1236, cont. Example of a medical record that may result in a DENIED claim Mrs. Smith is a female, age 70, with chronic right knee pain. She states she is unable to walk without pain and pain meds do not work. Therefore, she needs a total right knee replacement. Example of a medical record with more detail and support of medical necessity History: Mrs. Smith is a 70-year-old female who is suffering from end-stage Osteoarthritis (OA) of her right knee, worsening gradually over the past 10 years. Treatment has included NSAIDs which have not effectively relieved her pain/inflammation and which have recently begun to cause her gastric distress. She has also participated in an exercise program/physical therapy for the past 3 months without functional improvement. Sometimes the pain keeps her awake at night. She is using a cane and is no longer able to climb the five steps to her front door. Personal safety is compromised as she had falls x 3 in attempting the stairs to her home entrance. Her knee pain and stiffness limit her ability to perform ADLs. She cannot walk from her bedroom to her kitchen without stopping to rest. Investigations: X-ray (7/2/11): right knee shows joint space narrowing along with marginal osteophytes. Impression: Total Knee Arthroplasty (TKA) indicated. 18

19 Is this Surgical Procedure Medically Necessary? SSA? reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member Federal Register/Final Rule? Was the patient appropriately admitted as an inpatient? Is there an active LCD for the state in which the service was performed? Does the documentation meet the suggested guidance outlined in SE 1236? 19

20 What Defenses Do We Have if the Claim is Denied as Not Medically Necessary? Clinical Arguments Documentation should be reviewed by a clinician familiar with CMS s specific requirements. Obtain physician records for appeal and/or an affidavit to support medical necessity. Inpatient Only Procedure 20

21 What Defenses Do We Have if the Claim is Denied as Not Medically Necessary?, cont. Legal Arguments LCD 42 CFR and 42 CFR require the ALJ to apply an NCD to the facts of a specific claim, but permit the ALJ discretion when reviewing a denial based on an LCD or other program memoranda - LCDs and other policies are not binding on the ALJ and MAC, but must be given substantial deference. MLN Matters Article SE 1236 states: The Centers for Medicare & Medicaid Services (CMS) is publishing this article as an educational guide to improve compliance with documentation requirements for major joint replacement surgery. The article presents suggestions for documenting medical necessity to avoid denial of Medicare Fee-For-Service (FFS) claims. The use of this guide is not mandatory and does not guarantee payment. 21

22 Medical Necessity & Level of Care Determinations Inpatient vs. Observation 22

23 How is an Inpatient Defined? Federal/Medicare 42 CFR (a) an individual is considered an inpatient of a hospital, including a critical access hospital, if formally admitted as an inpatient pursuant to an order for inpatient admission by a physician or other qualified practitioner (d)(1) an inpatient admission is generally appropriate for payment under Medicare Part A when the admitting physician expects the patient to require hospital care that crosses two midnights. Medicare Benefit Policy Manual, Chapter 1, Section 10 Factors to be considered when making the decision to admit include such things as: The severity of the signs and symptoms exhibited by the patient; The medical predictability of something adverse happening to the patient; The need for diagnostic studies that appropriately are outpatient services (i.e., their performance does not ordinarily require the patient to remain at the hospital for 24 hours or more) to assist in assessing whether the patient should be admitted; and The availability of diagnostic procedures at the time when and at the location where the patient presents. 23

24 How is an Inpatient Defined?, cont. State Examples Georgia Rules and Regulations for Hospitals (g) Inpatient means a person admitted to a hospital for an intended length of stay of twenty-four (24) hours or longer. Montana Administrative Rule (26) Inpatient means a person who has been admitted to a hospital for bed occupancy for purposes of receiving inpatient hospital services. A person generally is considered an inpatient if formally admitted as an inpatient with an expectation that the client will remain more than 24 hours. The physician or other practitioner is responsible for deciding whether the client should be admitted as an inpatient. 24

25 How is an Inpatient Defined?, cont 2. Georgia Medicaid Manual Inpatient admissions of less than twenty-four hour s duration are subject to review for medical necessity of admission. A length of stay less than twenty-four hours may be considered inpatient if the services can be provided only on an inpatient basis. Outpatient services billed as inpatient are subject to recoupment after review for medical necessity and cannot be re-billed as outpatient. 25

26 Current Rules for Inpatient Status Payor Medicare Medicaid Medicaid MCOs Commercial Medicare Advantage Inpatient Rule Two Midnight Rule State regulatory definitions for medical necessity Typically use evidence based, clinical guidance such as MCG or InterQual, HOWEVER contract governs Typically use evidence based, clinical guidance such as MCG or InterQual, HOWEVER contract governs Two Midnight Rule (?); HOWEVER contract governs 26

27 Current Rules for Observation Status Payor Medicare Pay 1 48 hours of observation? Yes But See MOON Regulation. Pay > 48 hours of observation? Not > 48 hours unless rare and exceptional (Auto Edit!) Maryland Medicaid Yes No -may only reimburse up to 24 hours in an outpatient setting; applies to MD Medicaid, MCOs, and Behavioral Health. UHC Community Plan Carefirst Aetna Yes up to 24 hours No See above Yes up to 24 hours; then MN review No established maximum May pay Authorization required? No Med review used to be needed for > 24 hours, now won t be paid BlueChoice requires authorization Medical necessity review for > 24 hours 27

28 Medicare & the Two-Midnight Rule 28

29 Two-Midnight Rule Effective for DOS on or after 10/01/13 Has undergone several modifications/updates since its inception. Requirements Inpatient Order Expectation of hospitalization spanning two midnights Exceptions: Inpatient Only Procedures Unforeseen circumstances Case by case review 29

30 Updates to the Two-Midnight Rule CMS issued a revised policy regarding exceptions to the 2 Midnight rule in CMS-1633-F For admissions not meeting the two midnight benchmark, Part A payment is appropriate on a case-by-case basis where the medical record supports the admitting physician s determination that the patient requires inpatient care, despite the lack of a 2 midnight expectation. The QIOs will consider complex medical factors such as history and comorbidities, the severity of signs and symptoms, current medical needs, and the risk of an adverse event to determine whether the medical record supports the need for inpatient hospital care. These cases will be approved by the QIOs when the other requirements are met. 30

31 Updates to the Two-Midnight Rule, cont. This update is codified in 42 CFR (d)(3) as of November 13, 2015 (d) (3) Where the admitting physician expects a patient to require hospital care for only a limited period of time that does not cross 2 midnights, an inpatient admission may be appropriate for payment under Medicare Part A based on the clinical judgment of the admitting physician and medical record support for that determination. The physician's decision should be based on such complex medical factors as patient history and comorbidities, the severity of signs and symptoms, current medical needs, and the risk of an adverse event. In these cases, the factors that lead to the decision to admit the patient as an inpatient must be supported by the medical record in order to be granted consideration. 31

32 Two-Midnight Rule: Example of Achievable Best Practice Documentation This is an 84 year old patient admitted for treatment of a COPD exacerbation. She has multiple comorbid conditions including diabetes, CHF, and coronary artery disease. She is at risk for rapid deterioration, respiratory failure, and cardiac ischemia and requires IV antibiotics, frequent nebulizer treatments, and frequent vital signs. I expect that she will require at least two midnights of hospitalization this episode because she typically requires 2-3 days of IV steroids and has increased oxygen needs during these exacerbations. 32

33 Two-Midnight Rule: Current Audits QIO review Two Midnight initial patient status reviews resumed on 09/12/16. MAC review Reviews unrelated to patient status (e.g., coding reviews, reviews to determine the medical necessity of procedures, diagnostic studies, etc.). RAC review May conduct patient status reviews only for those providers that have been referred by the QIO as exhibiting persistent noncompliance with Medicare payment policies. CMS awarded new contracts on 10/31/16. Probe reviews Conducted for stays > 2 midnights to monitor for evidence of gaming, abuse, or delays in an effort to meet the Two Midnight presumption of medical necessity (CERT, FATHOM, PEPPER). 33

34 34

35 Two-Midnight Rule: Audits KEPRO, one of the the BFCC-QIOs states on its website: KEPRO utilizes both non-physician and physician reviewers for its review process. It has chosen to utilize a commercial screening tool, InterQual, to aid its nonphysician reviewers with the medical necessity review portion of these reviews. Should the documentation fail the initial utilization review screening, the medical record will be provided to a physician reviewer for his/her clinical review. NOTE: CMS considers the use of screening criteria as only one tool that should be utilized by contractors to assist them in making an inpatient hospital claim determination. (MLN Matters Number: SE 1037) 35

36 RAC Regions as Outlined in the Statement of Work 11/30/16 Compliance-Programs/Recovery-Audit-Program/Downloads/New_RAC-SOW-Regions-1-4-clean.pdf 36

37 Two-Midnight Rule: Benchmark Presumption that the claim is appropriately payable as a Part A claim if admission is 2+ midnights. The clock starts when treatment starts: Triage excluded Waiting room excluded Still not actually an inpatient until admission is ordered by a physician Claims reflecting one day of treatment will likely be chosen for audit or pre-pay denial, but may still be appropriate for Part A reimbursement. The potential for denials still exists in a two midnight stay Delay in services Delay in discharge Hospitalization not medically necessary Care guidelines can be useful to support the need for hospitalization vs. outpatient care 37

38 Two-Midnight Rule: General Rule for Expected 2+ Midnight Stays If an unforeseen circumstance results in a shorter length of stay than expected, Part A payment may still be made. The circumstances must be documented in the medical record. Examples: Death Transfer to another facility AMA departure Hospice election Unexpected recovery QIOs will consider complex medical factors that support a reasonable expectation of the needed duration of the stay. 38

39 Two-Midnight Rule: General Rule for Expected 0-1 Midnight Stays Previously CMS indicated that these claims should be billed as outpatient claims. Procedures defined as inpatient only are an exception. Revised exceptions policy pursuant to CMS-1633-F: for admissions not meeting the two midnight benchmark, Part A payment is appropriate on a case by case basis where the medical record supports the admitting physician s determination that the patient requires inpatient care, despite the lack of a 2 midnight expectation. QIOs will consider complex medical factors. 39

40 Keys to a Successful Defense Inpatient Stay Expected 0-1 Midnight Review the record for: Inpatient Order Documentation as to WHY inpatient care is required Complex medical factors Or, is this an inpatient only procedure or newly initiated mechanical ventilation? Inpatient Stay Expected 2 Midnights or More Review the record for: Inpatient order Documentation as to WHY admission is appropriate Documentation to support the expectation of the needed duration Or, were there unforeseen circumstances that occurred? 40

41 Two-Midnight Rule & Medicare Advantage Medicare Advantage Non-contracted MAOs are using the rule to deny claims. Contracted MAOs have started to utilize it as well. 41

42 Challenges & Risks 42

43 Testimony of Gloria Jarmon, Deputy Inspector General for Audit Services, OIG April 30, 2014 Hearing before House Committee on Ways and Means: Ideas to Improve Medicare Oversight To Reduce Waste, Fraud, and Abuse Fighting waste, fraud, and abuse in Medicare and other Department programs is a top priority. We use a range of tools in this fight, including audits, evaluations, investigations, enforcement authorities, and educational outreach. The key takeaway from my testimony today is that more action is needed from (CMS), its contractors, and the Department to reduce improper Medicare payments and billings and improve oversight of its Medicare contractors. Reducing improper payments and improving the oversight of contractors are two of the Department s top management and performance challenges and are critical to reducing Medicare waste, fraud, and abuse. 43

44 Center for Program Integrity Created in 2010 to strategically combat fraud, waste and abuse with a coordinated approach in Medicare and Medicaid. Accomplished through: Enhanced provider enrollment activities; Proactive data analysis; Close collaboration among law enforcement; Subject matter experts and program integrity contractors; and/or The investigation of complaints from various sources; provider on-site visits; and beneficiary interviews. 44

45 Multiple Entities/Contractors Federal Medicare Administrative Contractors (MAC) Recovery Audit Contractors (RAC) Comprehensive Error Rate Testing (CERT) Quality Improvement Organizations (QIO) Unified Program Integrity Contractors (UPIC) Zone Program Integrity Contractors (ZPIC) Supplemental Medical Review Contractors (SMRC) Office of Inspector General (OIG) Health Care Fraud Prevention and Enforcement Action Team (HEAT) Joint effort between HHS & DOJ Medicare Fraud Strike Force State Medicaid RACs Medicaid Integrity Contractors (MIC) Medicaid-Coordination/Fraud- Prevention/FraudAbuseforProfs/St ate-program-integrity-review- Reports-List.html Office of Inspector General (OIG) Medicaid Fraud Control Units 45

46 ZPIC: Medical Review Function An investigation is the expanded analysis performed on leads once such lead is vetted and approved by CMS to be opened as an investigation. The ZPIC shall focus its investigation in an effort to establish the facts and the magnitude of the alleged fraud, waste, or abuse and take any appropriate action to protect Medicare Trust Fund dollars. (MPIM, Chapter 4 Section 4.7) Reactive Referrals from MACs/CMS, HHS OIG tipline, law enforcement, whistleblowers Proactive Data-mining across years of claims data Fraud Prevention System (FPS) CMS-operated analytical and predictive tool 46

47 ZPIC: Extrapolation Other reviewers from MACs to HHS OIG can use extrapolation, but they are a key feature of the ZPIC program. The purpose of extrapolation is to save the administrative costs that would be necessary to investigate each claim. When a ZPIC finds what it believes is a sustained or high level of payment error, it can use sampling and extrapolation. CMS has not defined a sustained or high level. The determination of a sustained or high level of error is not subject to judicial review. (MPIM, Ch. 8, Section 8.4) 47

48 ZPIC: Case Study PSC conducted proactive data analysis. In 2010, PSC sent written request to Medical Records Administrator for medical records associated with claim sample Three years later, ZPIC sent Post Payment Review Results & Overpayment Determination to CEO Alleged insufficient documentation to justify medical necessity Denial premised on non-compliance with LCD s detailed service and documentation requirements Extrapolation Universe of 500 claims Sample of 50 claims, all denied post-payment $250, at issue on sample claims $2,250, lower limit (total estimate $2,500,000.00) 48

49 ZPIC: Case Study, cont. Worked quickly to put recoupment on hold Within 30 days under the provisions of Section 935 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ( MMA ) Developed arguments on both the audit process and the claim details Analyzed LCD at issue, applied it to facts of each claim Attacked quality & promptness of notice Sent appeals one for each claim and one for the extrapolation 49

50 ZPIC: Responding to a ZPIC Audit Assemble all medical records and other pertinent documentation. Review all relevant Medicare criteria and regulations Have properly trained team and/or attorney evaluate the cases The key skill is experience interpreting medical records in light of complex regulations & often fuzzy criteria and formulating a clear, targeted response. Ordinary denial management processes are likely under-prepared for the scope of a ZPIC audit and under-skilled for what s at stake. 50

51 LCD Language 51

52 LCD Language, cont. 52

53 Fraud, Waste & Abuse 53

54 The False Claims Act, 31 U.S.C Knowingly submitting a false or fraudulent claim for payment can lead to: Treble damages; and Fines of $5,500-$11,000 per claim For purposes of this regulation, the terms knowing and knowingly mean that a person, with respect to information: (1) has actual knowledge of the information; (2) acts in deliberate ignorance of the truth or falsity of the information; or (3) acts in reckless disregard of the truth or falsity of the information, and no proof of specific intent to defraud is required. 54

55 The False Claims Act, Statute of Limitations A civil action under section 3730 may not be brought more than six years after the date on which the violation of section 3729 is committed, or more than three years after the date when facts material to the right of action are known or reasonably should have been known by the official of the United States charged with responsibility to act in the circumstances, but in no event more than 10 years after the date on which the violation is committed, whichever occurs last. 55

56 What is Medicare Fraud? In general, fraud is defined as making false statements or representations of material facts to obtain some benefit or payment for which no entitlement would otherwise exist. These acts may be committed either for the person s own benefit or for the benefit of some other party. Examples of Medicare fraud may include: Knowingly billing for services that were not furnished and/or supplies not provided, including billing Medicare for appointments that the patient failed to keep; and Knowingly altering claims forms and/or receipts to receive a higher payment amount. 56

57 What is Medicare Abuse? Practices that, either directly or indirectly, result in unnecessary costs to the Medicare program. Abuse appears quite similar to fraud except that it is not possible to establish that abusive acts were committed knowingly, willfully, and intentionally. Examples of Medicare abuse may include: Misusing codes on a claim; Charging excessively for services or supplies; and Billing for services that were not medically necessary or services that do not meet professionally recognized standards. Both fraud and abuse can expose providers to criminal and civil liability. 57

58 Per Medicare Learning Network: there is no precise measure of health care fraud Fraud? Abuse? Improper Payment? Reasonable Minds can Differ? 58

59 Question: Can billing Medicare for [insert almost any service you provide here] when the documentation does not support medical necessity per CMS criteria be considered fraud or abuse? What about when the denial is not appealed? What about where there are many cases with this issue? 59

60 The False Claims Act and Enforcement If such activity is considered fraud or abuse, Providers are exposed to civil and criminal liability. Exclusion from Federal Healthcare Programs Loss of Licensure Corporate Integrity Agreement Civil monetary penalties Criminal penalties Imprisonment Criminal fines 60

61 OIG Semi-Annual Reports to Congress OIG Semi-Annual Report Period April 1 Sept 30, 2016 Oct 1 March 31, 2015 April 1 Sept 30, 2015 Crimin al Action s Civil Actions Investigative Receivables Due to HHS Investigative Receivables for Non-HHS $1.62 Billion + $607.4 Million $1.68 Billion + $332.6 Million $756.9 Million + $139.4 Million + 61

62 Qui Tam Provision Anyone may initiate the law suit on behalf of the government! (31 U.S.C. 3730) USA ex rel. Karin Berntsen v. Prime Healthcare Services, Inc. The Relator was a registered nurse employed by Defendant Alvarado Hospital when Prime acquired it in The suit alleges that Prime Healthcare defrauded the federal government of millions of dollars by billing Medicare for medically unnecessary inpatient short-stay admissions, which should have been classified as outpatient or observation cases. Complaint alleged that the hospital engaged in a systematic practice of maximizing revenues by, among other things, inducing physicians who work at Prime hospitals to increase the number of inpatient care admissions of Medicare beneficiaries who visit the Emergency Department (ED) at a Prime hospital, without regard to whether inpatient admission is medically necessary. 62

63 OIG Transcript for Audio Podcast: False Claims Act False Claims Act cases are in the news and many involve large companies, such as drug and device manufacturers or pharmaceutical companies. But there also are many cases involving smaller entities and individuals. For example, a recent FCA case involved a cardiologist who allegedly submitted claims to the Federal health care programs for services that were not supported by patient medical records and did not meet the billing criteria. Additionally, the physician allegedly billed separately for services that the government had already paid for as part of a bundled payment for a group of services. To resolve these allegations the doctor paid $435,000 and entered into a 5-year Integrity Agreement. 63

64 Corporate Integrity Agreements A Corporate Integrity Agreement (CIA) outlines the obligations an entity agrees to as part of a civil settlement. The organization agrees to the CIA in exchange for the OIG s agreement that it will not seek to exclude the entity from participation in Medicare, Medicaid or other Federal healthcare programs. Often paired with a Deferred Prosecution Agreement or Settlement Agreement. Monetary penalties can result from failure to comply with a CIA; a material breach of the CIA constitutes an independent basis for exclusion. 64

65 Recent OIG Civil Monetary Penalties At least 13 separate settlement agreements during 2016 between the OIG and physician practices/groups for HCPCS code G0452 (molecular pathology procedure; physician interpretation and report). Settlements spanned between $10,000 - $66,000! Allegations were: (1) no consultation request had been made; (2) no written narrative report by a consultant physician was produced that went beyond the report of the laboratory results; and (3) no exercise of medical judgment by a consultant physician was required. 65

66 Recent OIG Criminal and Civil Enforcement March 6, 2017; U.S. Department of Justice California Clinic Owner Sentenced to 63 Months in Prison for Role in Occupational Therapy Fraud Scheme A rehabilitation clinic operator in Los Angeles County was sentenced to 63 months in prison for his role in a $3.4 million Medicare fraud scheme that involved billing for occupational therapy services that were not medically necessary and not provided. He was also ordered to pay $2,407,857 in restitution after pleading guilty on Dec. 15, 2016, to one count of conspiracy to commit health care fraud. 66

67 Recent OIG Criminal and Civil Enforcement, cont. February 10, 2017; U.S. Attorney; Southern District of Florida Plantation Physician and Physician Practice to Pay $750,000 to Resolve False Claims Act Allegations Involving Medically Unnecessary Sinus and Throat Procedures Dr. Paul B. Tartell, an ENT physician practicing in Plantation, Florida and his practice Paul B. Tartell, M.D., P.L., d/b/a South Florida Sinus & Allergy Center, have agreed to pay $750,000 to resolve allegations that he violated the False Claims Act by billing for surgical endoscopies with debridement and laryngeal stroboscopies that were not provided or not medically necessary. February 1, 2017; U.S. Attorney; Eastern District of Kentucky Pain Management Physician Resolves False Claims Act Allegations Pain management physician Dr. Robert Windsor has agreed to the entry of a $20 million consent judgment to resolve allegations that he violated the False Claims Act by billing federal health care programs for surgical monitoring services that he did not perform and for medically unnecessary diagnostic tests. Dr. Windsor owned pain management clinics in Georgia and Kentucky that operated under the umbrella of National Pain Care, Inc., including clinics in Lexington, London, Somerset, Hazard, Prestonsburg, and Pikeville, Kentucky. 67

68 Compliance 68

69 OIG s Voluntary Guidance 1998 OIG Compliance Program Guidance (CPG) 2005 Supplemental OIG CPG Should be considered collectively when evaluating or developing a program Focus expected to be on areas of potential concern most relevant to the organization Benefits: Early detection & reporting minimizes financial loss to Hospital Demonstrates good faith effort to comply with federal requirements 69

70 Fraud & Abuse Risk Areas Submission of accurate claims & information considered single biggest risk area for hospitals Inaccurate or incorrect coding Upcoding Unbundling of services Billing for medically unnecessary services or services not covered Insufficient documentation 70

71 Specific Risk Areas for Incorrect Outpatient Procedure Coding Billing on an outpatient basis for inpatient-only procedures Submitting claims for medically unnecessary services by failing to follow the FI s local policies Submitting duplicate claims or otherwise not following the National Correct Coding Initiative guidelines Submitting incorrect claims for ancillary services because of outdated Charge Description Masters Improperly billing for observation services Improper E&M codes Same day discharge & Readmissions Etc., Etc. Etc. 71

72 Formal Commitment by Hospital s Governing Body for All Recommended Compliance Program Elements Should be Evident 1. Written standards of conduct, policies & procedures 2. Designation of chief compliance officer & committees that report to CEO & governing body 3. Regular, effective education & training for all affected employees 4. Maintenance of process to receive anonymous complaints 5. System to respond to allegations & enforcement of disciplinary action 6. Use of audits and/or other evaluation techniques 7. Remediation of identified systemic problems 72

73 Auditing & Monitoring Regular compliance audits by internal or external auditors with expertise in Federal & State requirements recommended Pepper (Program for Evaluating Payment Patterns Electronic Report) considered a guide for hospital s auditing & monitoring activities PEPPER contains a hospital s data for DRGs & discharges at risk for improper payment Three comparison groups: nation, MAC Jurisdiction, & state Outliers command attention! 73

74 Responding to an Audit 1. Anticipate the issues that are of concern. 2. Ensure that your response contains a complete medical record. 3. Paginate the documentation you intend to provide. 4. Create index/table of contents to assist the reviewers with finding critical documentation 5. If appropriate, provide a narrative that pulls together the story in association with the relevant regulations. 6. Consider affidavits or attestations to supplement when appropriate. 74

75 Mandatory Requirements: Self-Identified Overpayments Section 6402(a) of the Affordable Care Act established a new section 1128J(d) of the Act. Section 1128J(d)(1) of the Act requires a person who has received an overpayment to report and return the overpayment to the Secretary, the state, an intermediary, a carrier, or a contractor, as appropriate, at the correct address, and to notify the Secretary, state, intermediary, carrier, or contractor to whom the overpayment was returned in writing of the reason for the overpayment. Section 1128J(d)(2) of the Act requires that an overpayment be reported and returned by the later of: (A) the date which is 60 days after the date on which the overpayment was identified; or (B) the date any corresponding cost report is due, if applicable. Query: At what point does an overpayment identification occur? 75

76 Thank You For Your Attention! Questions? Comments? 76

77 Linda Fotheringill, Esq. Linda Fotheringill is a nationally recognized expert on Medicare denials and Managed Care/Commercial denials, and is a founding member of Washington & West, LLC and a partner in the law firm of Fotheringill & Wade, LLC. Ms. Fotheringill successfully assists hospitals across the country in overturning hopeless denials and generating millions of dollars in revenue that would otherwise be lost for Commercial, Medicare Advantage, or Government payers. Ms. Fotheringill began her career as a hospital-based Physician Assistant. She also had fourteen years of experience in the medical malpractice insurance industry as a claims representative with Medical Mutual Liability Insurance Society of Maryland. Ms. Fotheringill graduated cum laude from the University of Baltimore School of Law and is a member of the Health Care Financial Management Association, American Association of Healthcare Administrative Management, and American and American Association for Justice. In addition, she has presented for numerous professional organizations such as HFMA National and HFMA Regional Chapters, as well as for the American Hospital Association, AAHAM, and NAHAM. Ms. Fotheringill is also a lead developer of Quantum Appeals, a state-of the art RAC Tracking and Denial Management software application. 77

78 Sarah Mendiola, Esq., LPN, CPC Sarah Mendiola is a Senior Associate and Director of Clinical Services for the Baltimore, MD-based law firm of Fotheringill & Wade, LLC, and denial Defense Company of Washington & West, LLC. Ms. Mendiola has extensive experience overturning various Medicare, Medicaid, and Commercial plan denials. She has a comprehensive understanding of the Medicare appeals process and has successfully represented numerous clients at Administrative Law Judge hearings; and has obtained favorable results for claim denials from Zone Program Integrity Contractor (ZPIC) audits. She has also represented Maryland providers at administrative hearings for claim denials by Maryland Medicaid and is intimately familiar with the myriad issues surrounding commercial claims as well. Ms. Mendiola graduated from the University of Baltimore School of Law Magna Cum Laude, and holds a Bachelor of Arts in Jurisprudence from the University of Baltimore where she graduated Summa Cum Laude. Ms. Mendiola is also a Licensed Practical Nurse (LPN) in the State of Maryland and is certified as a Certified Professional Coder (CPC) as well. She is admitted to the Maryland Bar and is a member of the American Bar Association. 78

79 Disclaimer: Please Note The information conveyed in this presentation is for general educational purposes and is not legal advice. The application and impact of laws can vary widely, based on the specific facts involved. Given the constantly changing nature of state and federal laws, there may be omissions or inaccuracies in the information you receive during this program. Accordingly, any information is provided with the understanding that the presenter is not rendering legal, accounting, or other professional advice and services. As such, any information obtained in this presentation should not be used as a substitute for consultation with legal counsel or other professional advisors specifically retained for that purpose. While Fotheringill & Wade, LLC has made every attempt to ensure that the information contained in these materials is generally useful for educational purposes, Fotheringill & Wade, LLC and its agents & employees are not responsible for any errors or omissions or for the results obtained through the use of any information herein. 79