1. Hot Topics in Billing Compliance
Sponsored by the
Clinical Trials SIG
Kelly M Willenberg, MBA, BSN, CHRC, CHC

2. Goals of the Session
Discuss the Affordable Care Act and Its Impact on Clinical Trials
Impact of the Sunshine Act on Clinical Trials
Industry Issues for the Future
Current Trends from Recent Audit
Administrative Burden of Conducting Clinical Trials

3. What Is the Affordable Care Act?

4. Goal of the Affordable Care Act
One goal often mentioned is to decrease costs of health care
For compliance and auditing, there are some specific things the ACA does to address reimbursement “waste” and “errors

5. The Affordable Care Act
With the passage of the Patient Protection and Affordable Care Act and the federal requirement for tracking and reporting expenditures on physicians and teaching hospitals, Aggregate Spend reporting is becoming an increasingly challenging issue for the life sciences industry.

6. National Law Coming in 2014
Patient Protection and Affordable Care Act and Health Care Reform and Education Act
Require coverage of routine patient care costs starting in Does not include:
Cost of the investigational item, device or service
Cost of items/services for data collection and analysis needs not used in direct clinical management
Cost of services that are clearly inconsistent with widely accepted standards of care 6

7. Exception: does not apply to grandfathered plans
National Law Coming in 2014
Applies to group health plans and health insurance issuers offering group or individual coverage for plan years beginning on or after January 1, 2014
Exception: does not apply to grandfathered plans 7

8. National Law Coming in 2014
Trial must be:
For cancer/life-threatening disease, phases I-IV
Either:
Federally funded/approved
Associated with an IND
IND exempt
States/insurers may impose additional requirements or provide greater coverage 8

9. ACA “Core Elements” of a Compliance Program
Policies & Procedures: “The organization must have established compliance standards and procedures to be followed by its employees and other agents that are reasonably capable of reducing the prospect of criminal, civil, and administrative violations.”
Compliance Officer: “Specific individuals within high-level personnel of the organization must have been assigned overall responsibility to oversee compliance with such standards and procedures and have sufficient resources and authority to assure such compliance.”
Due Care in Discretionary Authority: “The organization must have used due care not to delegate substantial discretionary authority to individuals whom the organization knew, or should have known through the exercise of due diligence, had a propensity to engage in criminal, civil, and administrative violations under the law.”

10. ACA “Core Elements” of a Compliance Program
Education, Training & Communication: “The organization must have taken steps to communicate effectively its standards and procedures to all employees and other agents, such as by requiring participation in training programs or by disseminating publications that explain in a practical manner what is required.”
Auditing & Monitoring Plan: “The organization must have taken reasonable steps to achieve compliance with its standards, such as by utilizing monitoring and auditing systems reasonably designed to detect criminal, civil, and administrative violations under this Act by its employees and other agents and by having in place and publicizing a reporting system whereby employees and other agents could report violations by others within the organization without fear of retribution.”
Disciplinary Actions for Noncompliance: “The standards must have been consistently enforced through appropriate disciplinary mechanisms, including, as appropriate, discipline of individuals responsible for the failure to detect an offense.”

11. ACA “Core Elements” of a Compliance Program
Respond Appropriately to Compliance Issues: “After an offense has been detected, the organization must have taken all reasonable steps to respond appropriately to the offense and to prevent further similar offenses, including repayment of any funds to which it was not entitled and any necessary modification to its program to prevent and detect criminal, civil, and administrative violations.”
Periodic Assessments: “The organization must periodically undertake reassessment of its compliance program to identify changes necessary to reflect changes within the organization and its facilities.”

12. Implications for Research
What is the jurisdiction of the compliance program?
Credit for a compliance program requires that the compliance program cover the area being reviewed
Implications: Compliance programs will need to expand to include research in order to obtain “effectiveness” benefits

13. What Is the Sunshine Act?

14. Sunshine Act Origins & Goals
Policy Goal:
“You should know when your doctor has a financial relationship with the companies that manufacture or supply the medicines or medical devices you may need. Disclosure of these relationships allow patients to have more informed discussions with their doctors.”
Peter Budetti, MD – CMS Deputy Administrator for Program Integrity

15. Sunshine Act
High-Level Review of “Final Rule” for Physician Payment Sunshine Act (the “Sunshine Act”)
Who reports?
Who is covered by the reports?
Process for reporting
What is reported
Special rules for reporting research funding
Penalties
Compliance and operational implications

16. Questions With Sunshine Act
What is the impact on Physicians?
Where will the data be posted?
How will Sponsors track this data?
When will this be effective?
How often do we report?
What is the threshold for reporting?
How will clinical trial expenditures be captured?

17. What Payments Are Covered?
Covers payments of other transfers of value
Transfer of anything of value, unless excluded
Does not include transfers made indirectly to a covered recipient through a third party where the manufacturer is unaware of the identity of the covered recipient
Includes transfers to an entity or individual at the request of or designated on behalf of a covered recipient
Covered recipient
Physicians
Teaching hospitals

18. Impact of Sunshine Act Penalties for failure to properly report
Failure to report “in a timely manner in accordance with rules or regulations
Civil monetary penalty of $1,000 - $10,000 for each payment or other transfer of value not reported as required
$150,000 maximum CMP per annual submission
“Knowingly” fail to report “ in a timely manner in accordance with rules or regulations”
Civil monetary penalty of $10,000 - $100,000 for each payment or other transfer of value
$1 million maximum CMP annually
Knowingly = actual knowledge, acts in deliberate ignorance, acts in reckless disregard
Proof of specific intent to defraud is not required
Other potential penalties for non-compliance

19. Impact of Sunshine Act
To avoid (or minimize) the risk of running afoul of the Sunshine Act, a Coverage Analysis should be prepared.
A clinical trial coverage analysis is a document that identifies and analyzes who the appropriate payer (i.e. the Sponsor, Medicare or other third party payor) is for each item and service required by a clinical trial as stated in the protocol and schedule of events and verified within the current practice guidelines.

20. Billing Compliance

21. Benefits of a Coverage Analysis
Sponsor is paying for items and services that can legitimately be billed under existing billing rules
Both Sponsor and site can get a better understanding of what items and services are billable to Medicare and other third party payers
If Sponsor performs a coverage analysis it will create efficiencies in budget negotiations and clinical trial implementation
Ensures that items and services provided under a clinical trial are efficiently, effectively and compliantly billed to Medicare and other third party payors
Provides a useful tool to justify payments to physicians and institutions for purposes of reporting under the Sunshine Act
Interesting correlation between those who have a policy and those who include a rate for return.
Generally, more sophisticated sites include a rate for return in their overhead.

22. What Does the Future Hold?
More scrutiny with more responsibilities
Time intensive procedures
Back end bill hold and review
Auditing function necessary to ensure compliance
Medicare changes?
More global trials?

23. How Billing Compliance Effects the Industry
Rules and regulations regarding billing compliance including the NCD 310.1
Challenges in regards to billing compliance in cancer trials
Medicare Advantage Issue for oncology drug trials
Challenges oncology practices face with reimbursement

24. Five Common Billing Errors
Billing for services that are paid for by the sponsor
Billing for services promised free in the informed consent
Billing for services that are for research-purposes only
Billing for services that are part of a non-qualifying clinical trial
Billing Medicare Advantage Plans (Part C) when claims should be directed to the Medicare Administrative Contractor for drug trial

25. Cost Accounting and Budgets

26. Scrutinizing the Spending on Clinical Trials
Budgeting for clinical trial against a Coverage Analysis
Cost vs benefit ratio
Cost effectiveness for cooperative group trials
Getting cooperative group trials to understand and complete coverage analysis upfront so billing payers is not a factor
Helping each other do a better budget
Makes it easier to negotiate
Billing compliance is at the forefront
Ensures a site will not commit billing fraud

27. Budgeting Coverage Analysis is the start of a good budget
Know your costs up front
Read the documents
Realize that a consent or a contract can be detrimental to the site
Request line item budgets
Invoice sponsors for invoiceables

28. What You Should Know
The more the Sponsor pays for that is “routine costs”, the more the Site has to “stop” a bill from going out
If a Site promises something at no cost to the subject, they cannot bill regardless of the contract and budget
Sites must keep a eye on all payments that could be done incorrectly to ensure no fraudulent bill goes out

29. Cost Coverage Analysis at the Sponsor Level
Helps them to finalize protocol
It assists in a review of the schedule of events
Identify Standard of Care procedures
Review assumptions prior to preparing budget and sending to sites
Determines “qualifying” status of the trial
Generates supporting documents to provide sites and legal
Provides more information to sites
Negotiate Better Site Budgets

30. Auditing and Risk Assessment

31. A Good Audit Plan Includes
Internal controls in place as defined in regulatory requirements
Annual audit plan reflects outcome orientation
Audit methodology appropriate for type of area being reviewed
Audit outcomes reported to appropriate level of management
Audit frequency appropriate for level of risk to organization
Proactive vs. reactive audits
Audit strategy – protection of work papers and findings
Corrective Action verified
Re-audit to assure no re-occurrence of non-compliance
Audit of new processes, i.e.: new requirements, computer conversions, etc.

32. Value Creation Reactions to An Audit
Enthusiasm
Cynicism
Obligation
Doubt
Exhaustion
Fear

33. Audit Value Evolve such that its output is not punitive in nature
Approach must lead to enhanced processes and prescriptive, achievable corrective actions
Flexible, adaptive, and prompts change quickly
Meet the demands of the day
Shift away from conducting routine audits based upon research risk profiles from previous years
Engagement and collaboration with management
Called upon to assist with opportunity analysis rather than respond, look back, and assess failures “after the fact”
An Educational activity that promotes understanding

34. Compliance Value Proactive, thoughtful, and focused on education.
Creating a culture where doing the right thing is easier than doing the wrong thing.
Anticipate risk, regulatory pressures, and compliance challenges.
Able to provide analytical feedback on metrics, performance, and data.

35. Definition of a Risk Assessment
The process of evaluating a potential hazard, likelihood of suffering, or any adverse effects

36. Steps of Risk Assessment
Assemble Identified Research Risks, Score, and Prioritize
Determine What Should & Can Be Monitored Rather Than Audited
Consider Audit Resources and Who is On Point
Determine What Kind of an Audit is Necessary and Appropriate
Establish plan of audit

37. The Audit Process
“The process of audit should be relevant, objective, quantified, repeatable, and able to effect appropriate change.”

38. Research Risk Assessment
Reporting Frameworks of the Clinical Trials Billing Cycle
Budget Development and Approval
Process is highly distributed and variable
Registration of Research Subjects
No segregation and no tracking mechanism
Charge capture/billing for research related services
No system for tracking or reporting
Process for Resolving Billing Inquiries
Complaints and whistleblowers

39. Sample Audit Clinical Research Participant Billing - Questions
In assessing one’s own process for managing clinical trials billing, there are numerous questions to be asked PRIOR to testing/auditing.
Operations
Financial Management
Compliance Management
Personnel
Operations:
Segregation of charges
Are billable charges being separated from charges that should be debited against a study/grant account?
Who is determining what is billable to 3rd party payors? PIs? Coordinators?
Is this determination objective or subjective?
Is there a documented plan that is accessible by those performing charge capture so that they have reference material at this pivotal point in the billing continuum?

40. Sample Audit Clinical Research Participant Billing - Questions
Operations:
Registration
Are study subjects identifiable in registration (or scheduling) systems?
Is there an easy way for check-in personnel to validate a patient’s status as a research participant?
Are all points of entry for your facility equipped to deal with research patient scenarios?
Charge Capture
Do clinicians not associated with the study (i.e., other than the PI, a research nurse, or coordinator) have a simple to understand approach to noting a patient as a research participant?
Do lab techs and other non-research personnel have training in how to route research charges or how to identify and route routine test/procedure charges?
Billing
Is there a way to “scrub” charges before bills are dropped or prevent over- or inaccurate billing?
Is there a “bill hold” or some other manual, back-end bill review process?
What is the time line expectation for reviewing bills on hold and passing them along for final billing by a patient financial services staff member?

41. Sample Audit Clinical Research Participant Billing - Questions
Financial Management:
Budgeting
Is sponsor funding sufficient to cover costs of research? Of start up? Of performing a coverage analysis? Other fees?
Who drafts the budget? Where do they get access to charge master rates?
Is there a research rate schedule?
Is a coverage analysis being performed in consideration of Medicare standards, the NCD, or LCDs?
What other medical literature is used to independently determine conventional care?
Do sponsor contracts/agreements clearly state which patient care costs are covered?
Accounts Receivable
Are sponsors being billed and payments being collected (and credited to study accounts) in a timely manner?
When sponsors make payments, where do the checks go? Who is accountable?
Professional Fees
Are these being included in study budgets?
Being billed at all? Debited against the study budget?

42. Sample Audit Clinical Research Participant Billing - Questions
Compliance Management:
Investigations and Monitoring
Does compliance look at residual balances?
Could be viewed as kickback or may indicate that non-billable patient care events are not being debited against study accounts
PIs sometimes use surplus in a study to fund something else disconnected to the study
PIs may use surpluses to fund coordinators on a different study
What becomes of funds above a certain threshold?
Is a policy in place that defines how surpluses (and deficits) are reconciled?
If a deficit, is the PIs department accountable in any way for making up the difference?
Does compliance take a sample of studies and a sample of research participants on these studies and trace some bills through the process continuum to identify where (if any) control weaknesses may exist?
Finders fees and other incentives
Are there conflicts of interest that are incentivizing shady billing practices or leading to cases of non-disclosure of other fees?
Training
Is there a research compliance curriculum for PIs? Coordinators? Billing personnel? Those who develop coverage analyses?

43. Sample Audit Clinical Research Participant Billing - Questions
Personnel:
Roles and Responsibilities
Who is accountable for what?
Does your organization have appropriate controls in place to manage everyone from PIs to check-in personnel?
Are the often multiple competing interests and agendas understood?
PIs
Clinical trials office staff
Contracting / Tech transfer
Research finance & Billing
Department administrators
IT staff
Communication
Does your organization have a research portal or website with policies, information, downloadable forms, training, and FAQs?
Do PIs have a simple way to get information about their studies? Status of study initiation procedures? Financial status of study account?
Registration staff
Medical records & Coding
Pharmacy, lab, other ancillary services
Compliance
Counsel
Internal Audit

44. Medicare Secondary Payer Rules

45. Medicare Secondary Payer & Reporting
Clinical Trials Sponsors
Know which test subjects are enrolled in Medicare
Report related adverse and serious adverse events to Medicare quarterly
Reimburse the Clinical Trial site for treatment of the reported injuries
Fines -- Just 1 beneficiary, unreported for 1 year = $365,000.00
Clinical Trial Sites
Adopt a process to determine if other insurance is available before billing Medicare
BAD -- Medicare can fine providers, physicians, and other suppliers up to $2,000 for knowingly, willfully, and repeatedly providing inaccurate information related to the existence of other health insurance or coverage.
WORSE -- Face three times the amount of the bill (“overpayment”) under the False Claims Act.
Implement a process for properly billing the Sponsor

46. Medicare Secondary Payer & Reporting
Sponsors must report related adverse or serious adverse events in the following quarter
Reporting is triggered by the contractual obligation to pay
Not when the site submits a bill for reimbursement
Sponsors are required by law to determine if an injured test subject is a beneficiary
Sites must not bill Medicare if their CTA says the Sponsor will pay
Waiting for the sponsor to report does not relieve the clinical trial sites legal obligations under MSP Statutes
Statutes require site to implement a process to determine if other insurance is available
Billing Medicare is an “overpayment” if sponsor didn’t report the injury
Reimburse Medicare
Face treble damages

47. Other Administrative Issues
Budgeting
Contracting
Conflict of Interest
CRO’s
Dealing with Principal Investigators
Training, training and training

48. Group Exercise

49. PESTLE Exercise
Political
Economic
Social
Technical
Legal
Environments

50. References and Contact Information

51. References
PATIENT PROTECTION AND AFFORDABLE CARE ACT HEALTH-RELATED PORTIONS OF THE HEALTH CARE AND EDUCATION RECONCILIATION ACT OF PREPARED BY THE Office of the Legislative Counsel for the use of THE U.S. HOUSE OF REPRESENTATIVES (MAY 2010)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 402 and 403
NCD Clinical Trial Policy
Medicare Secondary Payor Rules

52. Kelly Willenberg, BSN, MBA, CHRC, CHC 864-473-7209 kelly@kellywillenberg.com www.kellywillenberg.com