Transcript Hot Topics in the Field of Billing Compliance

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
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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
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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
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ACA “Core Elements” of a Compliance
Program
1.
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.”
2.
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.”
3.
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
4.
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.”
5.
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.”
6.
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
7. 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.”
8. 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
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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
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Sunshine Act
1. High-Level Review of “Final Rule” for Physician Payment
Sunshine Act (the “Sunshine Act”)
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Who reports?
Who is covered by the reports?
Process for reporting
What is reported
Special rules for reporting research funding
Penalties
2. Compliance and operational implications
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Questions With Sunshine Act
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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
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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
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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.
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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
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What Does the Future Hold?
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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
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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
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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
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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 No system for tracking or reporting
related services
Process for Resolving Billing
Inquiries
Complaints and whistleblowers
Sample Audit
Clinical Research Participant Billing - Questions
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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 nondisclosure 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
Registration staff
Clinical trials office staff
Medical records & Coding
Contracting / Tech transfer
Pharmacy, lab, other ancillary services
Research finance & Billing
Compliance
Department administrators
Counsel
IT staff
Internal Audit
– 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?
MEDICARE SECONDARY PAYER
RULES
Medicare Secondary Payer &
Reporting
Clinical Trials Sponsors
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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
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Budgeting
Contracting
Conflict of Interest
CRO’s
Dealing with Principal Investigators
Training, training and training
GROUP EXERCISE
PESTLE Exercise
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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
[email protected]
www.kellywillenberg.com