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.