Understanding Health Reform s

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1 Compliance 101: Understanding Health Reform s New Compliance Requirements Uri Bilek Feldesman Tucker Leifer Fidell LLP

2 Does your organization have a designated Compliance Officer? a. Yes b. No c. Don't know

3 What services does your organization provide? a. Mental health services only b. Substance abuse services only c. Primary care services only d. A combination of the above

4 What government programs does your organization bill? a. Medicaid b. Medicare c. Both Medicaid and Medicare d. Neither Medicaid nor Medicare

5 Does your organization i have established internal monitoring and audit protocols for ensuring proper billing and coding? a. Yes b. No c. Don't know

6 How often does your organization screen individuals to confirm that they are not excluded by the Office of Inspector General from participating in federal health care programs (e.g., Medicare, Medicaid, CHIP)? a. Upon hire b. Annually c. Every 30 days d. Not sure e. Never

7 Compliance 101 > What is a compliance program? A proactive and reactive system of internal controls, operating procedures, and organizational policies to ensure that the rules applicable to your organization are regularly followed > What is the benefit of a compliance program? Effective compliance programs both prevent violations and reduce the potential for liability should such violations occur

8 Compliance 101 > A Corporate Compliance Program can help to achieve the following ggoals: Improves quality, efficiency, effectiveness of health care services and operational activities Reducing costs, potentially increasing reimbursement Demonstrate commitment to compliance and honest conduct Potential mitigation of penalties if non-compliance occurs

9 Before Health Reform... Transparency Expanded Definitions of Fraud Mandate to Spend Recovery Act Funds Appropriately Whistleblowers Increased Funding for Enforcement Self-Disclosure

10 Knowing Retention of Overpayments Lower Hurdle for Qui Tam (Whistleblower) Lawsuits Mandatory Return of Overpayments within 60 days Enhanced CMP Penalties Higher Risk of False Claims Act liability Health Reform Increased OIG Authorities RAC Program Expansions New Funding of Medicare and Medicare Program Integrity Enforcement Mandatory Compliance Programs Condition of Enrollment

11 Key Compliance Implications of Health Reform > Increased funding of program integrity activities > Greater OIG enforcement authorities > Higher risk of False Claims Act liability > Mandatory return and reporting of overpayments > Mandatory compliance programs

12 Increased Federal Funding of Program Integrity Activities > Health Reform Law appropriated $350 million to the Federal Health Care Fraud and Abuse Control Program to pay for additional i Federal Medicare and Medicaid id fraud and abuse enforcement activities, including $250 million in discretionary funding. $ 95 Million in FY 2011 $ 55 Million in FY 2012 $ 30 Million in FY 2013 and FY 2014 $ 20 Million in FY 2015 and FY

13 Increased Federal Funding of Program Integrity Activities > Health Reform Law expands Recovery Audit Contractor ( RAC ) program to Medicaid Contractors paid on a contingency basis according to the amount of identified overpayments (essentially a bounty system) RACs may also make referrals to law enforcement Health Reform Law requires each State Medicaid program to contract with at least one RAC States must have a provider appeal process 13

14 Increased OIG Enforcement Authorities > Under the Civil Monetary Penalties Law, the Office of Inspector General ( OIG ) may assess penalties for false and fraudulent conduct related to Federal health care programs OIG may assess penalties of up to $11,000 for each item or service falsely claimed and up to three times the amount falsely claimed OIG may also seek to exclude the provider from participation in Federal and State health care programs > The Health Reform Law increased the Civil Monetary Penalties ( CMPs ) that the OIG may impose on providers that receive payments under Federal health care programs: OIG may assess penalties of up to $15,000 per day for the failure to grant OIG timely access to documents OIG may assess penalties of $50,000 per false statement for knowingly making any false statement to a Federal health care program 14

15 Higher Risk of False Claims Act Liability > The FCA now forbids knowingly: Presenting or causing the presentation of, a false claim for payment Making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim Repaying less than what is owed to the Government Knowingly and improperly avoiding or decreasing an obligation to pay the Government Conspiring to defraud the Federal Government through one of the actions listed above > Note: False Claims Act defines knowingly as: Actual awareness of falsity Deliberate ignorance of the truth or falsity Reckless disregard of truth of falsity

16 Higher Risk of False Claims Act Liability > False Claims Act applies to payments made to providers under Medicare Advantage (Medicare managed care) and dmedicaid idmanaged care programs > False Claims Act applies to payments to providers from private insurers that participate p in State health insurance benefit exchanges when the payment includes any Federal funds

17 Higher Risk of False Claims Act Liability > Health Reform Law makes significant changes to qui tam provisions of the False Claims Act: Public disclosure does not require court to dismiss lawsuit where the Government opposes dismissal State proceedings and private litigation do not qualify as public disclosures Whistleblowers ers can proceed under the original source exception to public disclosure without direct (i.e., first-hand) and independent knowledge of the allegations so long as: The whistleblower voluntarily provided information to the Government prior to public disclosure and The whistleblower s information must be independent of and materially add to publicly disclosed information

18 Higher Risk of False Claims Act Liability > Health Reform Law codifies False Claims Act liability for any claims submitted for the provision of services which would violate the Anti- Kickback Statute > The Federal Anti-Kickback Statute: Prohibits persons and entities from knowingly or willingly Soliciting or receiving remuneration directly or indirectly, in cash or in kind To induce patient referrals or the purchase or lease of equipment, goods or services Payable in whole or in part by a Federal health care program > Health Reform Law eliminates Government s burden to prove that a provider has specific intent to violate the Anti-Kickback Statute or actual knowledge of the Anti-Kickback Statute

19 Higher Risk of False Claims Act Liability > Health Reform Law requires providers who have received overpayments e to: Report and return overpayment to HHS, the State, an intermediary, a carrier, or a contractor, as appropriate; and Notify the entity in writing the reason for the overpayment By the later of: 60 days from identification of the overpayment; or Due date for corresponding cost report (if applicable)

20 Mandatory Return of Overpayments > Reverse False Claims Imposes liability on a person who knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay pyor transmit money or property p to the Government > When is there an obligation to pay money to the Government? FCA (31 U.S.C. 3729(b)(3)): The term obligation means an established duty, whether or not fixed, arising from an express or implied contractual, grantor-grantee, or licensor-licensee relationship, from a fee-based or similar relationship, from statute or regulation, or from the retention of any overpayment 42 U.S.C. 1320a-7k(d) (from Health Reform Law 6402(a)) Any overpayment retained by a person after the deadline for reporting and returning the overpayment is an obligation (as defined in [the FCA] Therefore, once the timeline for returning and reporting has elapsed, the provider has an obligation to repay for purposes of the FCA

21 Mandatory Return of Overpayments > Questions raised by the obligation to return and report overpayments: What is an overpayment? Overpayment: funds that a person receives or retains under title XVIII [Medicare] or XIX [Medicaid] to which the person, after applicable reconciliation, is not entitled under such title 42 U.S.C. 1320a-7k(d) What is applicable reconciliation? Anything other than cost reporting? Who decides whether the provider is entitled to the funds and on what basis? Legal / Compliance decision?

22 Mandatory Return of Overpayments > Examples of Potential Overpayments: Unlicensed Providers Physician or other practitioner Midlevel l practitioners i exceeding scope of practice Billing and Record-keeping Issues No progress note or treatment plan (or illegible) Missing signature on progress note or treatment plan Start and/or end time of the session not recorded Improper coding or billing (past 90-day deadline) Not a billable service Disqualifications of Federal payment Employed or contracted with excluded individuals Failure to implement mandatory compliance program Violation of the Anti-Kickback Statute Violation of Stark Self-Referral Law

23 Mandatory Return of Overpayments > Questions raised by the obligation to return and report overpayments: When does the return and repay clock start running? By the later of (A) the date which is 60 days after the date on which the overpayment was identified (B) the date any corresponding cost report is due, if applicable. What constitutes identification? An allegation? A reasonable suspicion? The conclusion of a thorough audit? How is this affected by the need to determine whether the provider is entitled to the funds? Does the clock run while the determination of entitlement t is being made? Who represents the organization for the purpose of identifying an overpayment?

24 Mandatory Return of Overpayments > Key Recommendations: Appoint individual, such as compliance officer, with responsibility for monitoring process of investigating, quantifying, and refunding overpayments so that it occurs within applicable time limits Become familiar with applicable repayment procedures for Medicare and Medicaid and other payors py Require employees to report all potential overpayments to compliance officer for investigation

25 Mandatory Return of Overpayments > Key Recommendations: Establish internal reporting system to permit staff to report potential compliance issues to the compliance officer without fear of retaliation and in anonymous manner When questions arise, research billing rules and obtain expert guidance as appropriate Immediately investigate any reports of potential overpayments Implement robust compliance billing audits to identify ypotential false claim violations that have not been reported or discovered internally

26 Mandatory Return of Overpayments > Additional i Recommendations: Identify potential Anti-Kickback violations by reviewing affiliation agreements and vendor contracts with other health care providers such as physician groups, health centers, hospitals, clinical laboratories, and independent practice associations Cooperate during OIG and RAC audits, allowing access to documents that are not otherwise privileged Increase monitoring of Federal exclusions lists to every 30 days Verify statements and representations made in applications for Federal and State funding carefully for accuracy

27 Mandatory Compliance Programs > Under Health Reform Law: As a condition of enrollment in Medicare, Medicaid, and CHIP, providers must establish a compliance program Expansion of Medicaid under Health Reform Law Core components of compliance program to be established by the Secretary of HHS in consultation with the OIG Will be specific to particular industry or category of the supplier or provider Effective after HHS issues regulations

28 Mandatory Compliance Programs > OIG Compliance Program Guidance for Individual and Small Group Physician Practices 65 Fed. Reg et. seq. (October 5, 2000) Seven elements of effective compliance programs: Compliance Officer Internal Monitoring and Audits Written Standards and Policies Training and Education Programs Open Lines of Communication Respond to Detected Problems Disciplinary Standards Identifies high risk areas

29 Mandatory Compliance Programs > Key Recommendations: Do NOT wait for implementation date Review (or establish) a Corporate Compliance Program to ensure that it: Implements all seven elements Identifies and prioritizes high risk areas Operates under an annual compliance work plan Receives sufficient resources for size and budget of the community behavioral health organization Demonstrates effectiveness in promoting compliance

30 Helpful Resources > Health Reform > Recovery Act General recovery website Government-wide reporting website - HHS recovery websites OMB and GAO recovery websites > OIG Website (Guidances, Reports, and Publications) 30

31 Questions? Uri Bilek, Esq. (202) Feldesman Tucker Leifer Fidell LLP th St NW, 4 th Floor Washington, DC 20036

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