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Pathology Compliance: Strategies for Success in 2017

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Presentation on theme: "Pathology Compliance: Strategies for Success in 2017"— Presentation transcript:

1 Pathology Compliance: Strategies for Success in 2017

2 Learning Objectives Describe the characteristics of the Anti-kickback Statute, Stark Law and False Claims Act to modify your practice’s ongoing pathologist and staff education syllabus Appreciate the pathologists, residents and staff role in compliance Devise useful plans and activities that will encourage participation in compliance efforts

3 Anti-Kickback Statute (AKS)
Prohibits any person from Knowing and willful Solicitation, offer, payment, or receipt Of remuneration (whether direct or indirect) In exchange for government program referrals Remuneration = anything of value (cash, free rent, meals, etc.) Penalties Fines, jail, exclusion from Federal health care programs

4 Physician Self-Referral or “Stark” Law
The Stark Law Prohibits: Physician referrals To an entity furnishing designated health services If the physician (or a family member) has a financial relationship with the entity performing the DHS No intent element! A “financial relationship” can be a compensation arrangement, employment or independent contractor arrangement, lease arrangement - essentially any form of direct/indirect remuneration. Also includes ownership/investment interests. Penalties: Fines, exclusion from Federal health care programs

5 The False Claims Act (FCA)
31 USC §3729 Imposes liability for: Knowingly presenting a false claim for payment Knowingly using a false record or statement material to a false/fraudulent claim Conspiring to commit a substantive violation Knowing concealing or knowingly and improperly avoiding or decreasing an obligation to pay money to the government

6 The False Claims Act Penalties for violations: Initiated by:
Treble damages Per claim penalties between $10,781 and $21,563 (current rates) Initiated by: Qui tam actions Referrals to DOJ from HHS, CMS or contractors Pursuant to DOJ investigation

7 60 Day Rule Background Part of Affordable Care Act (ACA), enacted March 23, 2010 Referred to as the “Reverse False Claims Act” or “60 Day Rule” The ACA included a provision requiring the return of overpayments If not returned within 60 days of identification, can become a False Claim February 12, 2016 CMS issued Final Rule for Parts A and providing more guidance on 60 Day Rule No Final Rule for Medicaid yet

8 60 Day Rule Key Points Overpayment must be reported and refunded within 60 days of when the overpayment is Identified Permits 6 month good faith investigation plus 60 days = 8 months Applies to Medicare and Medicaid On the 61st day, you have “avoided” an obligation and violated the False Claims Act Failure to do so can result in False Claims Act liability, Civil Monetary Penalties and/or program exclusion

9 60 Day Rule Definitions Overpayment – “any funds that a person has received or retained… to which the person, after applicable reconciliation is not entitled… These funds might be received or retained due to fraud or due to more inadvertent reasons.” Examples: Payments received for non-covered services Payments received that are more than the allowable amount for those services Duplicate payments Insufficient documentation Not medically necessary

10 60 Day Rule Definitions Knowledge – same definition as in the False Claims Act – requires actual knowledge of overpayment or actions in reckless disregard or deliberate ignorance of overpayment Identification – “when the person has, or should have through the exercise of reasonable diligence determined that the person has received an overpayment and quantified the amount of the overpayment.” Reasonable diligence – includes proactive compliance activities and investigations conducted in good faith when the provider is in receipt of credible information that there is a potential overpayment

11 60 Day Rule Definitions Credible information – information that supports a reasonable belief that an overpayment may have been received Examples: Overpayment demand from a Medicare contractor Hotline complaints Review of billing shows incorrect coding that resulted in overpayment Internal audit results in evidence of overpayment Discovery of Stark or AKS violation

12 60 Day Rule Look Back Period
Once an overpayment is identified, cannot simply pay overpayment must investigate and look back 6 years to determine no additional overpayments Kane v. Healthfirst, Inc., 120 F. Supp. 3d 370 (S.D. N.Y. 2015) Prior to issuance of Final Rule NY Medicaid case In this case, the Court held that 60 days began to run as soon as provider was put on notice of a potential overpayment Also provider was liable even though it was a software error and not intentional or fraudulent

13 60 Day Rule Self-Reporting
This Final Rule provides that providers and suppliers must use an applicable claims adjustment, credit balance, self reported refund, or another appropriate process to satisfy the obligation to report and return overpayments

14 60 Day Rule Self-Reporting
OIG Self- Disclosure Protocol: August 17, 2013 Updated Provider Self–Disclosure Protocol Disclosure to CMS Disclosure to DOJ (through local US Attorney’s Office)

15 60 Day Rule Self-Reporting MACs
Medicare Program Integrity Manual Chapter 4, Section 4.16 MAC and ZPIC Coordination on Voluntary Refunds The following MACs use voluntary overpayment refund forms that must be submitted with payment WPS: “Voluntary refunds are payments from providers for debts that have not been demanded by Medicare.”; Form and payment Palmetto GBA: Form and payment Noridian: “Voluntary refunds can be made to Noridian by provider adjusted claims or by mailing an unsolicited check” Novitas: Form and payment

16 7 Elements of a Compliance Plan
OIG CMS Written policies and procedures Implement compliance and practice standards Designation of compliance officer Designate a compliance officer or contact Education and training program Conduct appropriate training and education Open communication Develop open lines of communication with employees Auditing and monitoring Conduct internal monitoring and auditing Internal investigation and enforcement Enforce disciplinary standards through well-publicized guidelines Response to identified offenses Respond appropriately to detected offenses and develop corrective action

17 An effective Compliance Plan..
Policies and procedures Written clearly with ‘real life’ examples Regularly review and revise as needed Establish along with guidance from the managing partners and Board members Include Acknowledgement statement signed by each staff member, managing partner, Board member Documentation of annual policy revision and review by all staff, managing partners, Board members

18 Examples of Written Policies
Standards Conduct Overview of prohibited activities Include examples of false claims, improper incentive for referrals Medical Necessity Comply with publicly available medical necessity requirements including CMS Documentation will support the medical necessity of the service provided Billing CPT and ICD codes used for billing accurately reflect the service provided Coding changes for billing purposes must be reviewed and approved by designated coding contact person Include policy on professional courtesy, physician requested patient discounts, charity designation

19 Examples of Written Policies
Standing/reflex Orders and Utilization More applicable to clinical labs Annual review, revision of any and all standing orders and/or reflex testing Marketing Statement about offering honest and informative marketing information and the restriction of financial inducements or kick backs for business Prohibition of enhanced services such as provision of free biopsy needles or discounted second/subsequent specimen Retention of Records No mandated retention period set out by OIG 7 years is the most common retention period if not involving patient information such as lab results or professional liability issues

20 Examples of Written Policies
Consideration for Teaching Pathologists Statement ensuring that all teaching pathologists know and understand CMS’ supervision and documentation requirements Policy to monitor as well as address compliance with these requirements Compliance as an Element of Performance Requisite training of newly hired employees, physicians Requisite training of all employees, physicians, and managing partners in newly adopted and/or revised compliance policies Strict compliance as an element of employment with disciplinary actions taken upon violation of compliance policies

21 An effective Compliance Plan..
Identify compliance officer and responsibilities Establishes and maintains policy manuals Serves as point of contact for compliance reporting (hotline, ) and policy clarification Oversees and provides compliance training to all employees, managing partners, Board members Adequately addresses all internal and external compliance concerns raised Implements corrective action under the direction of managing partners, Board members Regularly repots compliance plan status to managing partners, Board members

22 An effective Compliance Plan..
Educate and train Regularly update training and education sources Compliance training should be part of job requirement Test employees’ understanding of compliance topics; applies to managing partners and Board members Documentation of annual compliance training

23 An effective Compliance Plan..
Audit and monitor Proactive reviews in coding, contracts and quality of care Establish an audit plan and re-evaluate regularly When problems are identified, create corrective action plans to correct the issue Perform and document follow up audit once correction plan has been established Report findings to managing partners, Board members

24 An effective Compliance Plan..
Lines of communication Open lines of communication between all practice staff, including pathologists Enable an avenue for employees to report issues anonymously without fear of retaliation Use surveys and other tools to get feedback on training and other program elements Regularly meet with managing partners, Board members to discuss compliance concerns

25 An effective Compliance Plan..
Prompt response to compliance issues Create a system to track complaints, issues and their resolution Delegate and empower teams closest to the issue to perform reviews while being aware of potential conflicts of interest Act promptly with corrective action Consistent enforcement of policies through disciplinary action when warranted

26 An effective Compliance Plan..
Measure the plan’s effectiveness Develop plan with benchmarks and measurable goals Monitor how well the practice is meeting the goals When not met, investigate why and how to improve Assess if compliance program has sufficient exposure and funding Involve managing partner, Board members in creating program as well as providing regular updates

27 Common Compliance Issues

28 Questions?

29 Thank you! Brenda Cox Elizabeth Sullivan MT ASCP, CPC, FHFMA Member
McDonald Hopkins LLC The information in this presentation is provided for educational purposes only and is not legal advice. It is intended to highlight laws you are likely to encounter, but is not a comprehensive review. If you have questions or concerns about a particular instance or whether a law applies, consult your attorney.


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