Compliance Update NMAC ~ May 2017 Angelique M. Culver, Esq., LLM, CHC Chief Compliance & HIPAA Officer Vibra Healthcare, LLC
Objectives Ø To be able to identify Vibra s Obligations under its Corporate Integrity Agreement with the Office of Inspector General Ø To be able to identify key Regulatory Changes and Enforcement Trends Ø To be able to spot and navigate Regulatory Risks associated with Medical Directorships Ø To be able to identify and help other clinicians navigate Regulatory Risks associated with EMR Documentation
Disclosure I, Angelique Culver, have nothing to disclose.
Vibra s Corporate Integrity with Health and Human Services Office of Inspector General ( OIG ) Signed on September 20, 2016 Between Vibra Healthcare and the OIG for a term of 5 years Includes certain requirements that apply to Vibra and its Facilities Vibra filed required CIA Implementation Report on January 18, 2017 and will file Annual CIA Compliance Reports no later than November 19 th of each year
90 Day CIA Implementation Requirements Appoint a Full Time Corporate Compliance Officer Create/Maintain a Corporate Compliance Committee Designate a Vibra Healthcare Corporate Compliance Oversight Board of Managers Develop Written Policies and Procedures Develop Compliance Training Plan Provide 2 hours of Training to Vibra Healthcare s Compliance Oversight Board of Managers Engage Independent Review Organization Develop/Implement Internal Risk Assessment Develop/Maintain Compliance Reporting Mechanisms Screen employees and other Vibra Affiliates against the OIG s List of Excluded Individuals/ Entities upon hire and monthly thereafter
Vibra s Implementation Efforts ü Angelique Culver, Esq., LLM, CHC designated Full Time Corporate Chief Compliance Officer ü Corporate Compliance Committee composed of senior operational leaders meets monthly ü Compliance Oversight Board of Managers Created meets quarterly Members: Brad Hollinger, President & CEO Mike Thomas, Chief Administrative Officer Clint Fegan, Chief Financial Officer Doug Yohe, General Counsel Robert Sutton, EVP Human Resources and Risk Management Robert Caruso, Executive Director of Pennsylvania State Ethics Commission ü Policies and Procedures Implemented and available on VibraNet s Compliance Policy Site ü Compliance Training Plan developed and will be available on VibraNet s Compliance Policy Site ü Vibra s Compliance Oversight Board of Managers completed 2 hour training requirement on December 16, 2016 ü Vibra has engaged LW Consulting, Inc. as its IRO ü Risk Assessment/Internal Review policy available on VibraNet s Compliance Policy Site
Vibra s Compliance Program Structure Corporate - Compliance Program Structure v Compliance Oversight Board v CEO v Chief Compliance Officer & Staff v Corporate Compliance Committee Facility Compliance Program Structure v Facility Governing Bodies v Facility CEO v Facility Compliance Officers v Facility Compliance Meetings 8
Vibra s Implementation Efforts cont d ü Maintain Compliance Reporting Mechanisms: Employees and others can report compliance concerns to: Ø Their immediate supervisors Ø Facility leadership Ø Facility Compliance Officers Ø Corporate Compliance Officer Ø Vibra s Compliance Hotline manned by an independent 3 rd Party:
Vibra s Implementation Efforts cont d Lighthouse Services ~ 3 rd Party Hotline Vendor Toll Free: 1-886-238-7185 Toll-Free (Spanish): 800-216-1288 Email: compliance@vibrahealthcare.com Online Hotline Report: https://www.lighthouse-services.com/_standardcustomurl/ IncidentLandingPageV2.asp HIPAA concerns can also be reported via email at: HIPAA@vibrahealthcare.com
Vibra s Implementation Efforts cont d ü Vibra uses an independent 3 rd Party to screen employees and others required to be screened against OIG s Exclusions List under the CIA or by law/contract upon hire and monthly thereafter All employees, vendors, credentialed providers and external Board or Governing Body Members were screened within 90 days of September 20, 2016 Vibra will not contract, employ or affiliate with persons that have been sanctioned, convicted of healthcare fraud or related crimes, or excluded from participation in federal or state health care programs
Vibra s Implementation Efforts cont d ü Vibra s Exclusion Screening Obligations cont d: Vibra will remove from duty or service any currently affiliated person found to be sanctioned, excluded or convicted of the above type crimes All employees, vendors, credentialed providers, and external Board or Governing Body members have an obligation to immediately report to Vibra if they become sanctioned, excluded from participation in federal state or federal health care programs, or are convicted of healthcare fraud or related crimes
Independent Review Organization Obligations: Vibra s IRO will: 1. Review Annually selected claims from 3 LTCHS and 1 IRF 50 paid claims per facility 2. Such review will include review and determination of whether: a. Items and services furnished were medically necessary; b. Appropriately documented; c. Paid Claims correctly: i. Coded ii. Submitted; and iii. Reimbursed
Independent Review Organization Obligations: Vibra s IRO will: 3. Submit Findings to OIG, to include: a. Total Number and percentages of Overpayments resulting from inaccurate coding/claims submission b. Total Number and percentages of Overpayments resulting from inadequate documentation c. Total Number and percentages of Overpayments resulting from medically unnecessary items or services d. An Estimate of actual Overpayment amount Overpayments must be repaid within 60 days of Identification by IRO and can be Extrapolated where appropriate e. Recommendations for improvement of Vibra s systems and/or controls to ensure appropriate documentation, coding, billing and medically necessary items or services
CIA Reporting Obligations Vibra is Required to Report, within specified timeframes v Substantial Overpayments (as defined by Vibra and acceptable to the OIG) Focused on Medicare Overpayments Must be concerned with Medicaid Overpayments as well v Employing or affiliating with excluded persons or entities Must screen ALL new External Governing Body Members, Vendors, Providers, and Employees Must screen ALL Covered Persons every month v Certain violations of law Most concerned with violations of healthcare laws, fraud laws (FCA, Stark, Anti-Kickback, etc.) v Government Investigations; and v Certain Changes to Vibra s Compliance Program
Annual Report Annual Reports must include, among other things: Work plans developed, Internal audits performed, Corrective action plans developed in response to internal audits, and Steps taken to track the implementation of the corrective action plans. A summary of Hotline Calls that relate to Federal health care programs A summary of any audits conducted by any Medicare or Medicaid contractor or government entity or contractor, involving a review of Federal health care program claims, and Vibra s response/corrective action plan (including information regarding any Federal health care program refunds) relating to such audit findings Management Certifications
Required Annual Certifications Each year, the following persons are required to certify to the OIG that Vibra is in compliance with CIA and federal health care program requirements: v Vibra Healthcare CEO and Corporate Compliance Officer v Vibra Healthcare Compliance Oversight Board of Managers v Division Presidents v Facility CEOs v Chief Information Officer v Chief Strategy Officer v Chief Administrative Officer v EVP, Business Development and Strategic Market Expansion v EVP, Clinical Operations v SVP, New Market Development v EVP, Case Management
Regulatory Updates & Enforcement Trends
Regulatory Fines and Penalties Increased DRAMATICALLY! v False Claims Act ~ Submitting False/Fraudulent Claims or Statements Ø Was: $5,500 - $11,000 ~ Now: $10,781-21,563 v Physician Self Referral (Stark Law) ~ Financial Benefit to Physician or family based on volume or value of referrals by Physician: Ø Was: $15,000 ~ Now: $23,863 v Anti-Kickback ~ Financial or other Remuneration to Physician in exchange for referral: Ø Was: $50,000 ~ Now: $73,588
Regulatory Fines and Penalties Increased DRAMATICALLY! v HIPAA ~ Protection of the privacy and security of patient health information: Ø Was: $100 - $50,000 ~ Now: $110 55,010 v Beneficiary Inducement Prohibition ~ Financial or other Remuneration to Patient to influence patient s decision to select provider, practice or facility v Was: $10,000 ~ Now: $15,270
New CMP Triggering Events v Failing to grant OIG timely access to records; v Ordering or prescribing while excluded from a federal health care program; v Making false statements, omissions, or misrepresentations in an enrollment application or similar bid or application to participate in a federal health care program; v Failing to report and return an overpayment; and v Making or using a false record or statement that is material to a false or fraudulent claim.
Government s Focus on Medical Directors The Rules Ø Written Agreement Ø Signed by Both Parties Ø Duties Specifically Outlined Ø Compensation is Commercially Reasonable and based on Fair Market Value Ø Documentation is kept Evidencing time spent on Administrative Duties
Government s Focus on Medical Directors Common Pitfalls Ø Failure to adequately document services provided Ø Providing more or less than the services required by the Agreement Ø Failure to appropriately complete and submit timesheets
Enforcement Activities Medical Director Agreements Fairmont Diagnostic Center and Open MRI Inc and Dr. Jack Baker (2012) Paid $650,000 as a result of alleged Sham Medical Director Agreements Result: 12 Physicians Investigated - the OIG collected over $1.4 million in penalties from 11 physicians and excluded one physician for three years. The settlement amounts ranged from $50,000 to $195,016 per physician Hebrew Homes, Inc. (2015) - Paid $17 Million to the DOJ for Sham Medical Director Agreements
Good Documentation Mitigates Sham Medical Director Allegations What is the Government Looking For? Ø Are services described with specificity in Contracts? Ø Are there multiple Medical Directors for same services? Ø Is there evidence that the Medical Director is actually performing services as described in Contract? v Timesheets v Meeting Minutes v Emails v Educational Presentations Ø Did number of referrals from Medical Director increase only after signing Contract?
A Medical Director s Role in Compliance Medical Directors play critical role in promoting the right tone among the Medical Staff you must help promote and communicate the Vibra s Culture of Compliance
A Medical Director s Role in Compliance In Order to do this, you must: 1. Exhibit Compliant and Ethical Behavior 2. Know the Rules and how to spot Risky/Non- Compliant Behavior 3. Know to Whom and How to Report Non- Compliance 4. Know how to Create an Atmosphere of Open Communication
A Medical Director s Role in Compliance Work with team to craft the solutions that best meets the needs of the organization, help the team understand the rationale for the solution and oversee its successful implementation Make medical judgments regarding appropriateness of care, length of stay and medical necessity Promote physician compliance with clinical pathways and protocols and develop quality improvement strategies remain important priorities today
General Physician Compliance Considerations: Documentation
General Physician Compliance Ø Documentation: Physician Documentation is under fire v Is the physician documenting those actions/services required to be performed by a physician as a condition of medicare/medicaid compliance? IRF 3x Week Face to Face Requirement Admission Orders v Is the physician co-signing documentation of advanced practice practitioner (PA/NPs)? IRF 3x Week Face to Face Requirement Admission Orders
IRF - Face to Face Visit Requirement Responsibility of Rehabilitation Physician Documented face-to-face visits from a rehabilitation physician or other licensed treating physician with specialized training and experience in rehabilitation at least 3 days per week throughout the patient s IRF stay Meaning: Advanced Practice Practitioners may visit patient as part of Face to Face visit process, but Rehab Physician must see and evaluate patient AND co-sign APP s note with something like: Seen and evaluated, agree with PA s assessment
Admission Order Requirements Authentication of the practitioner order The physician certifies that the inpatient services were ordered in accordance with the Medicare regulations governing the order. This includes certification that hospital inpatient services are reasonable and necessary and in the case of services not specified as inpatient only under 42 CFR 419.22(n), that they are appropriately provided as inpatient services in accordance with the 2 midnight benchmark. The requirement to authenticate the practitioner order may be met by the signature or countersignature of the inpatient admission order by the certifying physician.
Clinical Documentation Risks It s a New World Paper Records: Not documented, not done. Electronic Records: You documented it, but did you really do it?
Sebelius Holder Letter September 24, 2012 False documentation of patient care is not just bad patient care; it s illegal. The indications include potential cloning of records in order to inflate what providers get paid. http://www.nytimes.com/interactive/ 2012/09/25/business/25medicare doc.html
What Auditors are Looking For Ø Authentication signatures, dates/times who did what? (metadata?) Ø Contradictions between HPI and ROS, exam elements and impression and plan Ø Wording or grammatical errors/anomalies Ø Medically implausible documentation
Copy/Paste Risks Inaccurate or outdated information Redundant information, which makes it difficult to identify the current information Inability to identify the author or intent of documentation Inability to identify when the documentation was first created
Copy/Paste Risks Propagation of false information Internally inconsistent progress notes Unnecessarily lengthy progress notes
Cloned Notes Documentation is considered cloned when each entry in the medical record for a beneficiary is worded exactly like or similar to the previous entries. Cloning also occurs when medical documentation is exactly the same from beneficiary to beneficiary. It would not be expected that every patient had the exact same problem, symptoms, and required the exact same treatment. First Coast Service Options, Medicare Part B newsletter 2006 (Definitions published by Medicare contractors as early as 1999.)
Cloned Notes Cont d November/December 1999 Medicare Bulletin: Cloned notes are notes that have little or no change from day to day and patient to patient. These types of notes do not support the medical necessity of a visit. More importantly, in some cases, they may not actually support that a visit occurred. Cloned notes may be construed as an attempt to defraud the Medicare program.
Copy/Paste at Issue in Malpractice Trial Defense Attorney: But the lab record shows that the kidney function was declining Judge: [interrupting] The physician notes state each day that kidney function was normal. How do you explain that in the face of deteriorating kidney function? Why would a physician write that, unless he hadn t looked at the lab testing or the patient? Another Judge: I cannot trust any of the physician notes in which this occurred and the only conclusion I can reach is that there was no examination of the patient it means to me that no true thought was given to the content that was going into the note.
Copy/Paste ~ Government s View Template Example A two (2) year old comes to the clinic for a well-child exam. The provider copies her generic two (2) year old well child exam template onto the patient s chart. The copied information states that the provider asked the family about certain symptoms and provided appropriate education for patients at a two (2) year old s level. However, the provider did not discuss choking hazards for two (2) year olds as was documented in the template.
Copy/Paste ~ Government s View Copy and Paste Example A patient comes to see his provider for a sinus infection. The same patient returns a week later with similar complaints, including no improvement regarding the sinus infection. However, upon this visit the patient sees a different provider within the practice. The new provider copies the first provider s note with no changes.
Copy/Paste Government s View Both Template and Copy/Paste Example could be viewed by the Government as submission of False/ Fraudulent Claim At the very least, improper basis for payment and recoupment of overpayment
First False Claims Act Settlement ~ Copy/Paste MD2U Paid $21.5 Million to Settle FCA Case (2016) MD2U utilized an EMR system that permitted easy cut, copy and paste medical notes from prior visits that occurred weeks, months, or even years prior to the current patient encounter Allowed MD2U to created the illusion NPPs were performing a significant amount of work during their patient encounters when, in fact, they were not. Billed for 60 min visits ~ Often spent only 10 mins per visit
Copy/Paste Best Practices 1. Validate/Confirm accuracy of all information copied - even if copied from your own previous note 2. The source of the copied information should always be referenced even if the physician has to free hand attribution 3. Strive for Brevity remove or do not copy information not relevant for current encounter
Copy/Paste Best Practices Cont d 4. Copy/Paste Should not be Used for Certain Parts of Inpatient Record: Medical Students: v Avoid copying Medical Student Notes v Never copy Medical Student Exam or Decision Making Medical, Family & Social History: v Carry forward acceptable, with physician validating accuracy during current encounter History of present illness, review of systems, physical examination, assessment, and plan: v Never copy/paste these items even from your own previous note
QUESTIONS?