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Research 101

Health Care Compliance Association Regional Conference

Columbus, OhioMay 8, 2015

Jennifer Lanter, MSPH, BSN, RN, CCRCDirector, Research & Special Billing Office

Agenda

� Research Compliance Basics

� Research Compliance Issues for Healthcare Providers

� Focus on Research Billing

� Key stakeholders for a research compliance program

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What is Research Compliance?

� Processes designed to ensure compliance with Federal, State, local and Institutional regulations governing Research.

� 2005 OIG HHS “Draft OIG Compliance Program Guidance for Recipients of PHS Research Awards”

B. Benefits of a Compliance Program� While the decision to implement a compliance program is entirely voluntary, OIG

believes that an effective compliance program provides numerous advantages that will inure to the benefit of institutions that chose to establish one. An effective compliance program addresses the Government’s and research community’s mutual goals of ensuring good stewardship of Federal funds by eliminating erroneous or improper expenditure of Federal research funds, improving administration of grants (both from the Federal Government and from private sources), and demonstrating to employees and the community at large the institution’s commitment to honest and responsible conduct.

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Relevant Regulations & Guidance (not exhaustive list)

� Code of Federal Regulations (CFR)� Title 2 – Grants and Agreements

� Various Admin, Cost Principle, and Audit Requirements

� Part 200 Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards

� Title 20 – Employee Benefits

� Chapter III – Social Security Administration

� Title 45- Public Welfare

� Part 46 (subparts B, C, D) DHHS, Protection of Human subjects

� Part 50 Financial Conflict of Interest

� Part 52 Grants for Research Projects

� Parts 160, 162, and 164, HIPAA

� Title 21- Food and Drugs

� Part 11 Electronic Records

� Part 50 PHS - Informed Consent

� Par 54 Financial Disclosure

� Part 56 IRB

� Part 58 Good Laboratory Practice

� Part 210 Good Manufacturing Practice

� Parts 312 & 314 IND, NDA

� Parts 511 & 514 Animal Investigations

� Part 600, 6001 Biologics

� Part 812, 813, 814 Medical Devices

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� 1938 Food Drug & Cosmetic Act

� 1949 Nuremberg Code

� 1964 Declaration of Helsinki

� 1979 Belmont Report

� 1990 International Conference on Harmonization (ICH)

� 1997 Good Clinical Practice

� 2000 CMS Clinical Trial Policy NCD

� 2007 FDAAA 801 (Clinicaltrials.gov)

� 2008 Public Access Policy

� 2010 Patient Protection & Affordable Care Act (PPAC)

� 2010 SCHIP Clinical Trial & Liability Alert

� 2011 Conflicts of Interest

� 2013 Physician Sunshine Act

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Why So Many Regulations?

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Research Compliance Areas (not all inclusive)

� Anti-Kickback & Stark

� Conflict of Interest

� Effort Reporting

� Environmental Health & Safety (Biosafety)

� Export Control

� False Claims

� Gene Transfer

� Grant/Project Management

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� HIPAA

� Human Subject Protection

� Laboratory Animal Welfare

� Laboratory Safety

� Radiation Safety

� Research Misconduct

� Research Billing

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AntiKickBack & Stark

� AntiKickBack 42 U.S.C. § 1320a-7b(b)� Prohibits activities to offer anything of value to induce

referrals.

� Stark 42 U.S.C. § 1395nn� Prohibits certain types of physician referrals where

financial relationships are involved.

� Research Considerations: � Are physicians referring patients into clinical trials

getting paid? If so, for what?

� Is the trial scientifically sound or a measure to provide physicians with products

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False Claim

� The False Claim Act does not require proof of intent to defraud the government.

� Providers can be prosecuted for an array of scenarios that result in false or fraudulent claims

� Research Considerations: � Biggest risk = Double Billing for items and services

� How do you know if a researchers is receiving payment for a service provided by Health System?

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HIPAA Privacy Rule

� Establishes conditions under which protected health information may be used or disclosed by covered entities for research purposes. � Requires authorization or waiver to disclose

� Data Use Agreements for Limited Data Sets

� Accounting for Research Disclosures

� Research Considerations: � How do you manage release of information for

research?

� Where are authorizations kept?

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Research Billing

� Research billing is a process to ensure that the costs for items and/or services associated with clinical trials are billed to the appropriate party.

� These services and/or items could be provided by the hospital and/or physician and result in payers, patients and the clinical trial being billed.

� Research Considerations:

� How do you manage processes to maintain compliance with research billing regulations and payer policies?

� 1995 Medicare IDE Regulations

� 2000 Medicare Clinical Trial Policy

� Medicaid and Commercial Payer Positions

� PPAC, MMSEA, Sunshine

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What You Need to Know for Research Billing Compliance

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What can You Do?

STRATEGIES

for

Research Billing Compliance

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Getting Started

� Team Approach is Necessary (PIs, CRCs, Finance, Revenue Cycle, Compliance, Operations)

� Start with a Research Compliance Committee or Work group that meets frequently to work through issues. Involve Senior Leadership

� Identify areas that need changed and risks

� Develop strategies and “Steps to Research Billing Compliance”

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Common Institutional Approaches

� Standardize Research Rates

� Create Central Research Billing Office

� Coverage Analysis and Budgeting Training

� Subject Notification

� Research Pre-Determination

� Special Research Billing Workflows

� Audits

� Software Solutions

Standardize Research Rates

� Easier to manage than different rates per study

� Institutions may have different rate structures for Industry vs. Government

� Methodology depends upon institutional philosophy about research

� Academic tends to focus on covering costs

� Private tends to focus on making profit

� Common strategies = % of charge, Medicare Reimbursement, DHHS negotiate agreements

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Centralized Research Billing Office

� Common in institutions who have been fined in the past

� Functions depend upon institution� Some are imbedded in CTO’s

� Some are housed in Compliance Offices

� Some are housed in Health Systems

� Some report to VP Research

…Can help to develop metrics and scorecards…

Coverage Analysis & Budget Training

� CA = process performed to ensure all of the necessary requirements are met for billing items and/or services associated with a clinical trial according to applicable rules and regulations

� Can provide stakeholders with budgeting, billing, and auditing tools through documentation of the billing determinations

� Some Institutions have dedicated offices responsible for performing CA

� Other Institutions make researchers responsible

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Steps to Performing a Coverage Analysis

1. Read critical study documents (Protocol, Contract, Budget, Consent)

2. Identify all protocol required services

3. Identify Research vs. Standard of Care (SOC)

4. Verify trial “Qualifies” for coverage of “Routine” services (IDE, CRP)

5. Verify “Routine” services are billable (NCDs, LCDs, Best Practice Guidelines)

6. Negotiate Budget & CTA

7. Ensure document consistency

8. Monitor billing

Complete Billing Grid / Budget Template

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Subject Notification

� Need some method to identify research patients

� Mechanism varies from Institution to Institution

� Dependent upon system capabilities

� Various Approaches:� Researchers Notify Providers via Fax or Email so accounts can

be identified

� Researchers provide participants with documents to give providers so accounts can be identified

� Accounts identified by: � Insurance Plan Code for Research

� Specific Account Type, FSC

� Research functionality in system

Name:

MRN

Dx:

Research

Study:

Research Pre-Determination

� Different from Pre-Certification

� Focus on determining if payer plan language excludes services related to a clinical trial

� Role is to obtain Pre-Authorization for services related to participation in a clinical trial and to appeal any denials related to research

� Particularly important for Investigational Device coverage

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Research Billing Workflows

� Common approaches:

� Hold all accounts for review

� Time Consuming, Labor Intensive, Expensive

� Hold only research related accounts for review

� Less Costly, Higher risk

� Separate Research from Patient Accounts from beginning and bill without holds

� Risk of billing accounts incorrectly

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Audits

� Compare

� Billing Grids

� Orders & Notifications

� Actual billed services

� Revise Processes as Necessary

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Software Solutions

� Clinical Trial Management Systems (CTMS)

� To reduce reliance on custom programs, excel spreadsheets, faxes, etc.

� Processes for compliance checklist

� Billing Reports

� Integration with billing systems

Stakeholders Dependent Upon Focus Area

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Research Billing Stakeholders

Hospital & Provider Leadership• CFOs, CEOs• Physician Boards• Managed Care/Contracting• Access & Revenue Cycle (Scheduling,

Registration, ADT, Pre-Certification, Financial Counseling, Revenue Management /CDM, Ancillaries & Cost Centers, MIM/Coding. Billing/Cash Collection. Denial Management

• Compliance• Legal• Finance• Purchasing• Information Technology

Research Leadership• Physicians & Department Chairs• Investigators• Research Staff (Coordinators)• Grants & Contracts• Institutional Review Board• Accounts Payable• Compliance• Sponsors• Participants

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QUESTIONS?

Jennifer Lanter, MSPH, BSN, RN, CCRCDirector, Research and Special Billing Office (RBSO)

Room 325, 660 Ackerman Road, Columbus, OH, 43218614-2932115 Office | jennifer.lanter@osumc.edu

614-293-2103 RBO Helpline | research.billing@osumc.edu

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