New Government Focuses on Fraud and Abuse Enforcement Friday, - - PowerPoint PPT Presentation
New Government Focuses on Fraud and Abuse Enforcement Friday, January 29, 2016 | 1:30 PM Eastern/12:30 PM Central Sponsored by the ABA Center for Professional Development ABA Health Law Section Greater San Antonio Healthcare Foundation South
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Sponsored by the ABA Center for Professional Development ABA Health Law Section Greater San Antonio Healthcare Foundation South Texas Chapter, American College of Healthcare Executives South Texas Chapter, Healthcare Finance Management Association
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Department of Justice FY14:
defendants
Enforcement Action Team)
– Strike Forces in 9 cities – 2 in Texas – 165 indictments, informations, criminal complaints against 353 defendants that together billed $830M to Medicare
– Ongoing commitment to criminal enforcement – Increased focus on individual accountability
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– 31 U.S.C. §§ 3729 to 3733 – Primary tool to combat fraud, waste, and abuse – Treble damages and civil penalties – Whistleblower actions – qui tam provision – Separate criminal and administrative remedies
– 423 HCF qui tam actions – $330 million paid to whistleblowers in HCF cases (before attorney’s fees!) – In 2015, HCF accounted for majority of total FCA recoveries ($3.58 billion), qui tam suits (632), and whistleblower awards ($597 million)
– Increased focus on individual accountability – Affordable Care Act changes:
– More statistical sampling [U.S. ex rel. Ruckh v. Genoa Healthcare, LLC, 2015 WL 1926417 (M.D. Fla. 2015)]
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– 867 criminal actions (Medicare and Medicaid) – 539 civil actions and agency proceedings
– 1,700 related to convictions for crimes against health care programs – 189 related to patient abuse and neglect
– Increased use of administrative remedies
– Regulatory action on HCF matters – Self disclosure protocol – Technology and data analytics
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– 31 U.S.C. § 3729(a)(1)(G) – Overpayment = obligation under False Claims Act
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Protection Act
years and/or a fine of up to $500,000 for buying/selling beneficiary or provider identification numbers
encourage increased data sharing between federal government and state Medicare programs to better identify fraud, waste, and abuse
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Medicare/Medicaid
services, supplies, or other items
– www.oig.hhs.gov/compliance
*Affordable Care Act Provider Compliance Programs: Getting Started Webinar Medicare Learning Network June 17, 2014/June 26, 2014
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Simon Sinek TED Talk: Start with Why
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Abby loves reading to her dad and is one of the brightest children in her 1st grade, despite suffering a massive brain injury in a car crash when she was 6 months old.
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The Parker triplets can now run together, after Matthew received his second kidney transplant at University Hospital. His 1st grade teacher was his “perfect match” living donor.
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www.americanbar.org | www.abacle.org Magnet: The “Gold Standard” in patient care 5% of U.S. hospitals U.S. News & World Report: #1 in San Antonio #6 in Texas Top 50 in the U.S. for Nephrology
CNOR Strong Certified
National Quality Measures for Breast Centers™
U.S. HHSC
2009 - 2014 Executive Director’s Award
2013 Excellence through Diversity Award
Specialized care: Good health, safety & supporting our community: Technology, employee learning & efficiency:
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References: Collins, James C. Good to Great: Why Some Companies Make the Leap--and Others Don't. New York, NY: Harper Business, 2001. Sinek, Simon. Start with Why: How Great Leaders Inspire Everyone to Take Action. New York: Portfolio, 2009.
14 year-old Caden from Kerrville, TX. Trauma survivor. Runs track and plays basketball with his prosthetic leg.
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GOVERNMENT
US Attorneys Office State Attorneys General Office
Health Benefits Program
OIG CMS FBI DOJ DEA FBI FDA HHS
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(with Pharma experience at Pfizer), who will reportedly provide expert guidance to Fraud Section prosecutors regarding corporate compliance programs and remediation efforts.
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Adjustment Act Improvements Act of 2015
and increase the government’s and relators’ settlement leverage
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recently released its 2016 Work Plan.
activities that OIG plans to pursue with respect to HHS programs and
"accountable those who do not meet program requirements or who violated Federal health care laws."
penalties where appropriate.
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Work Plan can serve as a useful resource for companies to use in planning internal audits and in training.
many of which are continuations from the 2015 Work Plan. The Plan places a priority on the reconciliation of outlier payments and new inpatient admission criteria, which implicates the "two midnight policy.“
associated with defective medical devices a priority.
payments for replaced medical devices were made in accordance with Medicare requirements.
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Health and Human Services (HHS) announced creation of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) to gather resources and focus on cooperation to help prevent waste, fraud and abuse in the Medicare and Medicaid programs, and crack down on the fraud perpetrators.
false billings, kickbacks and theft involving healthcare providers across South Texas — part of a nationwide crackdown.
represented $7 million in federal insurance payments that prosecutors said resulted from false billings and kickbacks by healthcare providers across the region.
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Inspector General at the Texas Health and Human Services Commission, will encourage Medicaid providers to report issues to the state.
in state-administered benefits: Medicaid; the Supplemental Nutrition Assistance Program (SNAP), or food stamps; Children’s Medicaid, or CHIP; the Women, Infants and Children (WIC) nutrition program; and Temporary Assistance for Needy Families, or TANF.
made to health care providers and those made to recipients. Overpayments can occur through a simple error or by design — either by the beneficiary or the provider.
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to hold corporate officials responsible for the misconduct of their subordinates” Lew Morris, OIG Inspector General PBS Nightly Business Report, March 2010
employee” of any entity convicted of fraud in connection with delivery of health care item or service (including misdemeanor)
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The organization must periodically assess the risk of improper conduct as part of design, implementation, and modification of the Compliance Program Areas of significant concern should be used as a starting point for a manufacturer’s legal review of its particular practices and for development of policies and procedures to reduce or eliminate potential risk
Risk assessment
The organization must implement written standards and procedures to prevent and detect improper conduct
Compliance standards and procedures
Defines roles, responsibilities and reporting lines for Compliance Program personnel The organization has designated a Compliance Officer and Compliance Committee to be accountable
Knowledgeable leadership and governing authority; high-level direction
Element Guideline Overview
The organization must use reasonable efforts not to include within the substantial authority personnel of the organization any individual whom the organization knew, or should have known through the exercise of due diligence, has engaged in illegal activities or other conduct inconsistent with an effective Compliance Program
Due diligence in authority personnel
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The organization must take reasonable steps to: monitor and audit to detect improper conduct; periodically evaluate the effectiveness of the Compliance Program; and establish an internal system to report or seek guidance regarding potential or actual improper conduct Monitoring, auditing, self-evaluation, and reporting systems The organization must promote and enforce its program consistently and through appropriate incentives and disciplinary measures Consistent discipline and appropriate incentives The organization must take reasonable steps to respond appropriately to the improper conduct and to prevent further similar conduct after improper conduct has occurred Appropriate response and modification Communication and training The organization must develop effect lines of communication to enable employees to easily ask questions and report potential problems The organization must communicate periodically its standards and procedures and
Element Guideline Overview
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– False Claims Act Violations – 60 Day Overpayment Rule
– Instances of potential fraud involving Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(f)) – All providers subject to 42 C.F.R. Part 1003 may use – Cases resolved under the Civil Monetary Penalties Law, 42 U.S.C. § 1320a-7a, and Exclusion Statute, 42 U.S.C. § 1320a-7(b)(7) Have to acknowledge potential liability; no admission necessary
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Matters Ineligible For OIG Self-Disclosure Protocol:
Request advisory opinion from Industry Guidance Branch
Referral Disclosure Protocol
42 U.S.C. § 1320a-7b(b)
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providers of services and suppliers to disclose an actual or potential violation of section 1877 of the Social Security Act (the Stark Law).” – Authorizes the Secretary to reduce the amount due and owing for violations of section 1877 of the Act. In reducing the amount due and
– The nature and extent of the improper or illegal practice – The timeliness of such self-disclosure – Cooperation in providing additional information – Other factors the Secretary deems appropriate
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– Simply labeling a document “Privileged and Confidential – Attorney- Client Privilege” is not a sufficient basis to claim the privilege. – Likewise, sending non-privileged information through an attorney (or cc- ing the attorney on an email) does not make the communication privileged. – Routine Compliance correspondence may be copied to the Legal Department for information purposes, but should not be considered privileged. – Non-routine requests by Compliance for legal assistance should be separately communicated to the Legal Department, marked privileged, and only copied to management on a need-to-know basis.
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– Once a matter has been referred to Legal, the internal review or investigation should be led by the lawyer (in consultation with Compliance). – Legal should report the results of its privileged review to Compliance. – The Legal review and advice should remain privileged and shared only
– Compliance’s implementation of any action plan following the Legal review would not normally be privileged.
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