Compliance 101

Kris Mastrangelo, OTR/L, LNHA, MBA. V.4.15.21 Copyright © 2021 All Rights Reserved ... CMS (Centers for Medicare & Medicaid Services), RAI User's Manual ...

HHI Compliance 101 5.3.21
Compliance 101
5.3.21

Compliance 101
Harmony Healthcare International (HHI) "HHI C.A.R.E.S. about Care"
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About Kris
Kris Mastrangelo OTR/L, LNHA,
MBA
President and CEO Owns and operates Harmony Healthcare International (HHI) a Nationally recognized, premier Healthcare Consulting firm specializing in C.A.R.E.S. There are no nonfinancial disclosures to share.
"HHI C.A.R.E.S. About Care."
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Speaker and Planning Committee
Disclosure
· Disclosures: The planners and presenters of this educational activity have no relationship with commercial entities or conflicts of interest to disclose. Please visit https://www.harmony-healthcare.com/hhi-team for all speaker's financial and nonfinancial disclosures
· Planners:
­ Kris Mastrangelo, OTR/L, LNHA, MBA ­ Joyce Sadewicz, PT, RAC-CT ­ Pamela Duchene, PhD, APRN-BC, NEA, FACHE
· Presenter:
­ Kris Mastrangelo, OTR/L, LNHA, MBA

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Learning Objectives
1. The learner will be able to state the 7 elements of Compliance 2. The learner will be able to describe 3 reasons to establish a
Compliance Program 3. The learner will be able to identify the intent of the False Claims Act

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Historical Perspective of Compliance

Seven Elements

P-R-E-P-A-R-E
Policies and Procedures Reporting and Investigating Education and Training Prevention and Response Auditing and Monitoring Responsibility/Oversight of Compliance Officer/Committee Enforcement, Discipline and Incentives

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Historical Perspective of Compliance

· Compliance is not new; it reaches back to the 1860's during the Civil War When the False Claim Act (FCA) was passed
· The False Claim Act (FCA) was passed to prevent profiteers from selling bogus goods to the Union army
· The False Claim Act (FCA) has become a powerful weapon against fraudulent claims issued by healthcare providers
· The FCA mandates fines and penalties of double and triple False Claim against a government agency

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Historical Perspective of Compliance
· In 1996 the Health Insurance Portability and Accountability Act (HIPAA) authorized the creation of the Medicare Integrity Program
· This program directed federal agencies (HHS, DOJ, Department of Labor) to develop weapons to combat fraudulent claims and abusive practices of healthcare providers

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Office of the Inspector General
· Since the late 1990s, long before the Affordable Care Act legislation mandated that providers put a compliance plan in place, the Office of Inspector General (OIG) started a major initiative to support health care professionals in establishing a compliance program for their offices, organizations and practices

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The Affordable Care Act
· The Affordable Care Act (ACA) was passed by Congress and then signed into law by the President on March 23, 2010
· On June 28, 2012, the Supreme Court rendered a final decision to uphold the health care law
· ACA mandates compliance programs for all nursing homes by March 23, 2013

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Affordable Care Act
· Section 6401 of the Affordable Care Act provides that a "provider of medical or other items or services or supplier within a particular industry sector or category" shall establish a compliance program as a condition of enrollment in Medicare, Medicaid, or the Children's Health Insurance Program (CHIP)

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Affordable Care Act
· The Affordable Care Act further required the Secretary of Health and Human Services (HHS), in consultation with the HHS Office of Inspector General (OIG), to establish "core elements" for provider and supplier compliance programs. In doing so, HHS has the discretion to determine the timeline for implementation of the core elements and the requirement to have a compliance program.

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Affordable Care Act Program Mandate
· Intended to induce all health care professionals to implement a compliance program
· Will aid health care providers in better protecting themselves from risk of improper conduct

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Fraud, Waste and Abuse
· The Government Accountability Office has designated Medicare as a program at high risk for fraud, waste, and abuse
· Payments to skilled nursing facilities (SNFs) have been identified as vulnerable to abuse
· In 2012 the Office of Inspector General (OIG) found that approximately 25% of SNF Claims were billed in error

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Wall Street Journal, November 12, 2012
· Thomas Burton, November 2012: ­ "More intensive services were done than actually performed" ­ "Patients could not benefit from it" ­ "Cutting fraud" Obama

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OIG Report Claims in 2009
· 25% billed all claims in error: 1.5 billion · 26% claims not supported in the medical record · 542 million in overpayment · "Majority" error "up coded"* · Many Ultra High
* Original RUG was a higher paying RUG than the revised RUG

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OIG Report Claims in 2009

Billing Errors
Issues found with skillednursing facilities' Medicare claims, based on an outside review of 2009 data

75.10%
Properly billed

Source: Department of Health and Human Services Office of Inspector General

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20.30%
Billed for a more expensive treatment
2.50%
Billed for a less expensive treatment than was provided
2.10%
Billed for a condition not covered by Medicare

OIG Recommendations

· Increase and expand reviews of SNF claims:
­ CMS should instruct its contractors to conduct more medical reviews of SNF claims
· Use its Fraud Prevention System to identify SNFs that are Billing for Higher Paying RUGs:
­ CMS should use its Fraud Prevention System to identify and target these SNFs
· Monitor Compliance with the New Therapy Assessments:
­ As of October 2011, SNFs must complete a "change of therapy" assessment when the amount of therapy provided no longer reflects the RUG and an "end of therapy" assessment when therapy is discontinued for 3 days
­ CMS should instruct its MACs and RACs to closely monitor SNFs utilization of these assessments through analyses of claims data. Such analyses will identify SNFs that are using the assessments infrequently or not at all.

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Compliance Programs

· In 2012, the government received the highest amount of whistleblower complaints in its history
· This, combined with the advent of the Affordable Care Act and PEPPER, leaves the entire SNF industry under overwhelming scrutiny for accurate payment
· Numerous changes taking place specifically within the reimbursement process
· Medicare and Medicaid billing are now the most prominent risk areas in healthcare

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Compliance
· The Office of Inspector General encourages SNFs to develop and implement a compliance program to protect their operations from fraud and abuse
· Beginning in 2013, SNFs are required to have a compliance program

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False Claims Act
· The False Claims Act ("FCA") is violated where any person:
­ Knowingly presents, or causes to be presented, to the U.S. government a false or fraudulent claim for payment or approval
­ Knowingly makes, uses or causes to be made or used, a false record or statement material to get a false or fraudulent claim paid
­ Conspires to defraud the government by getting a false or fraudulent claim paid

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False Claims Act
· Critical changes have occurred with the False Claims Act · Most noteworthy change, leaders be advised:
­ Revision of the "intent" to submit an incorrect claim
· Historically, proof of "intent" was required to prosecute · Today, no proof or specific intent to defraud is required

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Fraud and Abuse defined
· If you Would Have, Could Have or Should Have known it is defined as fraud
· The government only needs to show: 1. The provider had "actual knowledge of the information" or 2. The person acted in "deliberate ignorance" of the truth or the falsity of the information, or 3. The person or provider acted in "reckless disregard" of the truth or falsity of the information

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Fraud and Abuse Defined
· Abuse is [billing for] "acts inconsistent with sound medical or business practice"
· Abuse can be found where conduct is unintentional but where said conduct directly or indirectly results in an overpayment to the healthcare provider

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False Claims Act
· Types of FCA cases include:
­ Therapy or other services that are deemed unreasonable and medically unnecessary
­ Quality of Care ("standard of care claims or worthless claims") ­ Services provided by individuals excluded from the
Medicare/Medicaid program ­ Billing errors resulting in overpayments

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False Claims Act
· No specific intent to defraud is necessary · No proof of actual damages, such as payment or approval of the claim
needed for liability to attach · Civil penalty from $5,500 to $11,000 per false claim UPDATE · Penalties can include three times the amount of damages the
government sustained:
­ If report the violation with 30 days of discovery, damages can be significantly reduced
­ If the organization reports first the violation a qui tam is less likely

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False Claims Act
· The FCA allows a private person to bring a false claim action on behalf of the government
· This provision encourages employees to become whistleblowers
· The Justice Department revealed that in 2014 nearly $6 billion dollars were recovered under the FCA, over half of that amount was due to cases filed by whistleblowers

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The Patient Protection and Affordable Care Act (PPACA)
· In August 2015, the government sued a NY Hospital for violations of the FCA for allegedly failing to refund overpayments for two years after notice of potential billing errors due to a software glitch
· The court agreed with the government that, under the PPACA, an overpayment is identified when a provider has determined, or "should have determined through the exercise of reasonable diligence," that it has been overpaid

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What is Compliance?

What Is Compliance?
· Prevention · Detection · Collaboration · Enforcement · Efforts to reduce Fraud, Waste and Abuse

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What Is Compliance?
· Compliance is an ongoing process · A system of policies and procedures to assure compliance with
federal and state laws governing the organization · A Compliance program must be effective · Part of the organization structure and culture · A commitment to an ethical way of conducting business · A system of doing the right thing

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Who Needs Compliance?

· Physician Practices · Hospitals · Nursing Facilities · Home Health Agencies · Medicare and Choice
Organizations · Ambulance Suppliers · Third Part Billing

· Pharmaceutical Manufacturers
· Laboratories · Teaching Institutions · Research · DME · Others

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Why Implement A Compliance Program?
· Paybacks to the fiscal intermediaries may result in audits · Probation and court ­imposed programs · Government designed programs · Exclusion from governmental programs · Reduce threat of whistleblowers (qui Tam) lawsuits

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Why Implement A Compliance Program?
· Demonstrates to the community a strong commitment to honesty and responsibility as a trustworthy provider
· Reinforces employee's innate sense of right and wrong. Providing employees with ways to express concerns to management (hot line, open communication, etc.,) providers strengthen relationships of trust with employees

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Why Implement A Compliance Program?
· Helps providers fulfill their legal duty to government and private payors:
­ For example, submitting a claim for reimbursement for an item of service, the provider is affirming the claim is truthful and the services provided are consistent with the program requirements
­ Internal monitoring of claims is an integral part of a compliance program

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Why Implement A Compliance Program?
· Compliance programs are cost effective:
­ Requires commitment and resources ­ Can outweigh the expense in defending a fraud investigation

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Why Implement A Compliance Program?
· Provides a view of employee and contractors' behavior related to fraud and abuse:
­ Provides ongoing training and education ­ Monitors understanding and compliance with rules ­ Provides a process for discipline for those who violate the rules

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Why Implement A Compliance Program?
· Quality of care is enhanced by a Compliance program through having a code of conduct. A code of conduct establishes the vision. The vision statement and implementation is established through:
­ Training employees ­ Continuous self-assessment ­ Prompt response to deficiencies ­ Enhance the highest quality care

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Why Implement A Compliance Program?
· A comprehensive Compliance program provides established procedures for promptly and efficiently responding to problems that may arise:
­ These processes in place can lead to early detection and reporting reducing risk and loss of potential false claims

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Why Implement A Compliance Program?
· A effective compliance program can mitigate any sanction imposed by government:
­ A reduction in criminal fines in cases where the organization has an effective Compliance program in preventing and detecting fraud, waste and abuse

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Why Implement A Compliance Program?
· Voluntarily implementing a Compliance program is preferable
than waiting for the OIG enforcing through a Corporate Integrity Agreement (CIA)

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Compliance Seven Elements & QAPI

Seven Elements

P-R-E-P-A-R-E
Policies and Procedures Reporting and Investigating Education and Training Prevention and Response Auditing and Monitoring Responsibility/Oversight of Compliance Officer/Committee Enforcement, Discipline and Incentives

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Compliance
· The government only needs to show:
1. The provider had "actual knowledge of the information" or 2. The person acted in "deliberate ignorance" of the truth or the falsity of
the information, or 3. The person or provider acted in "reckless disregard" of the truth or
falsity of the information

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Compliance Programs
· Providers have only 120 days to correct MDS errors and submit a billing adjustment for Medicare Part A claims
· Late identification of billing errors yields mandatory self disclosure within 60 days of overpayment identification
· It is a felony not to return the payment · The civil penalty equates to $5,500 to $11,500 per false claim along with
three times the amount of damages which the government sustained

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Compliance Programs
The only defense for an incorrect claim is a great offense in the form of an effective Compliance Program

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QAPI
What is QAPI?
· "QAPI is about critical thinking. It involves figuring out what is causing certain problems and implementing interventions and solutions that address the root causes of the problems, rather than just the symptoms."
Karen Schoeneman, Past Technical Director, CMS Division of Nursing Homes

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Closing Thoughts
· State the intent of the False Claims Act · Know the top 3 reasons to establish a Compliance Program · Institute all 7 elements of Compliance

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Key References

· CMS (Centers for Medicare & Medicaid Services), Medicare Program Integrity Manual, Retrieved from: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMsItems/CMS019033.html
· CMS (Centers for Medicare & Medicaid Services), Medicare Benefit Policy Manual, Chapter 8 http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c08.pdf , Oct. 2016
· CMS (Centers for Medicare & Medicaid Services), 5 Star Technical Users Guide http://www.cms.gov/Medicare/Provider-Enrollment-andCertification/CertificationandComplianc/downloads/usersguide.pdf , Aug. 2016
· CMS (Centers for Medicare & Medicaid Services), Quality Measures Users Manual https://www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/Downloads/MDS-30-QM-Users-Manual-V10.pdf, April 2016
· CMS (Centers for Medicare & Medicaid Services), RAI User's Manual http://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/MDS30RAIManual.html October 2016
· Department of Health and Human Services; Office of Inspector General, Inappropriate Payments to Skilled Nursing Facilities Cost Medicare More Than a Billion Dollars in 2009, November 2012

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Key References
· National Archives and Records Administration, Federal Register · CMS QAPI Tools Directory page · PEPPERResources.org · Protecting Access to Medicare Act of 2014 · Improving care transitions between the nursing facility and the acute-care hospital settings ­ AMDA · CMS.gov · Institute of Medicine, "A CEO Checklist for High-Value Health Care" ­ www.iom.edu/CEOChecklist · Interventions to Reduce Acute Care Transfers - http://interact2.net/index.aspx · The Business Case for Lower Hospital Readmission Rates. James Michel, American Health Care
Association. October 4, 2014.

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Key References

· Long Term Care Past Present Future, Daniel Swagerty, MD, MPH, CMD, AMDA Foundation Chair www.vamda.org/Swaggerty%20AMDA%20Future.pptx
· Grabowski, D., and O'Malley, J. (2007). The Costs and Potential Savings Associated with nursing facility Hospitalizations. Health Affairs. 207; 26 (6): 1753 ­ 1761.
· Joshi, Dr. P.H., Maulik, May 4, 2011. Healthcare Transformation: What Will it Take? Health Research & Educational Trust & American Hospital Association.
· Hospitals and Care Systems of the Future. American Hospital Association Committee on Performance Improvement Report, September 2011.
· Post-Acute Care Integration ­ Today and In the Future. DHG Healthcare, Center For Industry Transformation. July 2014.
· Current Trends in System Delivery Reform. James Michel. American Health Care Association. October 2014. · Michelli, Joseph (2008) The New Gold Standard: 5 Leadership Principles for Creating a Legendary Customer
Experience Courtesy of the Ritz-Carlton Hotel Company, McGraw-Hill, New York, NY

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Key References
· Top 5 Policies That Will Impact Your Post-Acute Customers, HIDA. Andrew E Van Ostrand, VP, Government Affairs, First Quality. October 2014.
· Trends in Hospital-Post Acute Acute Provider Relationships. Erik Johnson, SVP, Avalere Health. September 2014. · QAPI Boot Camp, Carol Benner, Sc.M., 2014 · http://www.stratishealth.org/pubs/qualityupdate/f13/reform.html · http://www.ahcancal.org/research_data/trends_statistics/Pages/default.aspx · The Post-Acute Care Environment, Compliance and the Affordable Care Act. Alissa Vertes & John Armstrong,
HealthPRO. January 2015. · AHCA, NCAL (April 8-9, 2015) Quality Cabinet Committees' Strategic Planning Meeting, Linthicum Heights, MD · Centers for Disease Control and Prevention http://www.cdc.gov/getsmart/healthcare/implementation/core-
elements.html · MLN Connects, Oct. 21, 2015: The IMPACT Act of 2014 and Data Standardization

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Thank You!

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Connect With Kris
kmastrangelo@harmony-healthcare.com 617.595.6032

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@KrisMastrangelo @KrisBharmony @KrisBharmony @Krismastrangelo

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