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

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

What Is the Affordable Care Act?

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

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.

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 2014. 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

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

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

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.”

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.”

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.”

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

What Is the Sunshine Act?

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

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

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?

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

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

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.

Billing Compliance

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.

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?

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

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

Cost Accounting and Budgets

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

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

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

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

Auditing and Risk Assessment

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.

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

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

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.

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

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

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

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

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?

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?

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?

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?

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

Medicare Secondary Payer Rules

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

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

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

Group Exercise

PESTLE Exercise Political Economic Social Technical Legal Environments

References and Contact Information

References PATIENT PROTECTION AND AFFORDABLE CARE ACT HEALTH-RELATED PORTIONS OF THE HEALTH CARE AND EDUCATION RECONCILIATION ACT OF 2010 - 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 310.1 - Clinical Trial Policy Medicare Secondary Payor Rules

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