Presentation on theme: "Hot Topics in Billing Compliance"— Presentation transcript:
1 Hot Topics in Billing Compliance Sponsored by theClinical Trials SIGKelly M Willenberg, MBA, BSN, CHRC, CHC
2 Goals of the SessionDiscuss the Affordable Care Act and Its Impact on Clinical TrialsImpact of the Sunshine Act on Clinical TrialsIndustry Issues for the FutureCurrent Trends from Recent AuditAdministrative Burden of Conducting Clinical Trials
4 Goal of the Affordable Care Act One goal often mentioned is to decrease costs of health careFor 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 2014Patient Protection and Affordable Care Act and Health Care Reform and Education ActRequire coverage of routine patient care costs starting in Does not include:Cost of the investigational item, device or serviceCost of items/services for data collection and analysis needs not used in direct clinical managementCost of services that are clearly inconsistent with widely accepted standards of care6
7 Exception: does not apply to grandfathered plans National Law Coming in 2014Applies to group health plans and health insurance issuers offering group or individual coverage for plan years beginning on or after January 1, 2014Exception: does not apply to grandfathered plans7
8 National Law Coming in 2014Trial must be:For cancer/life-threatening disease, phases I-IVEither:Federally funded/approvedAssociated with an INDIND exemptStates/insurers may impose additional requirements or provide greater coverage8
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 reviewedImplications: Compliance programs will need to expand to include research in order to obtain “effectiveness” benefits
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 ActHigh-Level Review of “Final Rule” for Physician Payment Sunshine Act (the “Sunshine Act”)Who reports?Who is covered by the reports?Process for reportingWhat is reportedSpecial rules for reporting research fundingPenaltiesCompliance 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 valueTransfer of anything of value, unless excludedDoes not include transfers made indirectly to a covered recipient through a third party where the manufacturer is unaware of the identity of the covered recipientIncludes transfers to an entity or individual at the request of or designated on behalf of a covered recipientCovered recipientPhysiciansTeaching hospitals
18 Impact of Sunshine Act Penalties for failure to properly report Failure to report “in a timely manner in accordance with rules or regulationsCivil 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 annuallyKnowingly = actual knowledge, acts in deliberate ignorance, acts in reckless disregardProof of specific intent to defraud is not requiredOther potential penalties for non-compliance
19 Impact of Sunshine ActTo 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.
21 Benefits of a Coverage Analysis Sponsor is paying for items and services that can legitimately be billed under existing billing rulesBoth Sponsor and site can get a better understanding of what items and services are billable to Medicare and other third party payersIf Sponsor performs a coverage analysis it will create efficiencies in budget negotiations and clinical trial implementationEnsures that items and services provided under a clinical trial are efficiently, effectively and compliantly billed to Medicare and other third party payorsProvides a useful tool to justify payments to physicians and institutions for purposes of reporting under the Sunshine ActInteresting 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 responsibilitiesTime intensive proceduresBack end bill hold and reviewAuditing function necessary to ensure complianceMedicare changes?More global trials?
23 How Billing Compliance Effects the Industry Rules and regulations regarding billing compliance including the NCD 310.1Challenges in regards to billing compliance in cancer trialsMedicare Advantage Issue for oncology drug trialsChallenges oncology practices face with reimbursement
24 Five Common Billing Errors Billing for services that are paid for by the sponsorBilling for services promised free in the informed consentBilling for services that are for research-purposes onlyBilling for services that are part of a non-qualifying clinical trialBilling Medicare Advantage Plans (Part C) when claims should be directed to the Medicare Administrative Contractor for drug trial
26 Scrutinizing the Spending on Clinical Trials Budgeting for clinical trial against a Coverage AnalysisCost vs benefit ratioCost effectiveness for cooperative group trialsGetting cooperative group trials to understand and complete coverage analysis upfront so billing payers is not a factorHelping each other do a better budgetMakes it easier to negotiateBilling compliance is at the forefrontEnsures a site will not commit billing fraud
27 Budgeting Coverage Analysis is the start of a good budget Know your costs up frontRead the documentsRealize that a consent or a contract can be detrimental to the siteRequest line item budgetsInvoice sponsors for invoiceables
28 What You Should KnowThe more the Sponsor pays for that is “routine costs”, the more the Site has to “stop” a bill from going outIf a Site promises something at no cost to the subject, they cannot bill regardless of the contract and budgetSites 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 protocolIt assists in a review of the schedule of eventsIdentify Standard of Care proceduresReview assumptions prior to preparing budget and sending to sitesDetermines “qualifying” status of the trialGenerates supporting documents to provide sites and legalProvides more information to sitesNegotiate Better Site Budgets
31 A Good Audit Plan Includes Internal controls in place as defined in regulatory requirementsAnnual audit plan reflects outcome orientationAudit methodology appropriate for type of area being reviewedAudit outcomes reported to appropriate level of managementAudit frequency appropriate for level of risk to organizationProactive vs. reactive auditsAudit strategy – protection of work papers and findingsCorrective Action verifiedRe-audit to assure no re-occurrence of non-complianceAudit of new processes, i.e.: new requirements, computer conversions, etc.
32 Value Creation Reactions to An Audit EnthusiasmCynicismObligationDoubtExhaustionFear
33 Audit Value Evolve such that its output is not punitive in nature Approach must lead to enhanced processes and prescriptive, achievable corrective actionsFlexible, adaptive, and prompts change quicklyMeet the demands of the dayShift away from conducting routine audits based upon research risk profiles from previous yearsEngagement and collaboration with managementCalled 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 PrioritizeDetermine What Should & Can Be Monitored Rather Than AuditedConsider Audit Resources and Who is On PointDetermine What Kind of an Audit is Necessary and AppropriateEstablish 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 CycleBudget Development and ApprovalProcess is highly distributed and variableRegistration of Research SubjectsNo segregation and no tracking mechanismCharge capture/billing for research related servicesNo system for tracking or reportingProcess for Resolving Billing InquiriesComplaints 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.OperationsFinancial ManagementCompliance ManagementPersonnelOperations:Segregation of chargesAre 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:RegistrationAre 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 CaptureDo 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?BillingIs 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:BudgetingIs 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 ReceivableAre 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 FeesAre 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 MonitoringDoes 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 accountsPIs sometimes use surplus in a study to fund something else disconnected to the studyPIs may use surpluses to fund coordinators on a different studyWhat 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 incentivesAre there conflicts of interest that are incentivizing shady billing practices or leading to cases of non-disclosure of other fees?TrainingIs 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 ResponsibilitiesWho 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?PIsClinical trials office staffContracting / Tech transferResearch finance & BillingDepartment administratorsIT staffCommunicationDoes 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 staffMedical records & CodingPharmacy, lab, other ancillary servicesComplianceCounselInternal Audit
45 Medicare Secondary Payer & Reporting Clinical Trials SponsorsKnow which test subjects are enrolled in MedicareReport related adverse and serious adverse events to Medicare quarterlyReimburse the Clinical Trial site for treatment of the reported injuriesFines -- Just 1 beneficiary, unreported for 1 year = $365,000.00Clinical Trial SitesAdopt a process to determine if other insurance is available before billing MedicareBAD -- 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 quarterReporting is triggered by the contractual obligation to payNot when the site submits a bill for reimbursementSponsors are required by law to determine if an injured test subject is a beneficiarySites must not bill Medicare if their CTA says the Sponsor will payWaiting for the sponsor to report does not relieve the clinical trial sites legal obligations under MSP StatutesStatutes require site to implement a process to determine if other insurance is availableBilling Medicare is an “overpayment” if sponsor didn’t report the injuryReimburse MedicareFace treble damages
47 Other Administrative Issues BudgetingContractingConflict of InterestCRO’sDealing with Principal InvestigatorsTraining, training and training
51 ReferencesPATIENT 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 SERVICESCenters for Medicare & Medicaid Services42 CFR Parts 402 and 403NCD Clinical Trial PolicyMedicare Secondary Payor Rules
52 Kelly Willenberg, BSN, MBA, CHRC, CHC 864-473-7209 firstname.lastname@example.org www.kellywillenberg.com