academic aaccaaddeemmiicc academic medical …...academic aaccaaddeemmiicc academic medical centers...

Academic Academic Academic Academic Medical Centers Medical Centers Medical Centers Medical Centers

(AMC)(AMC)(AMC)(AMC)Immersion SessionImmersion SessionImmersion SessionImmersion Session

Hala Helm, JD, MBAHala Helm, JD, MBAHala Helm, JD, MBAHala Helm, JD, MBA

Vice President, Chief Compliance OfficerVice President, Chief Compliance OfficerVice President, Chief Compliance OfficerVice President, Chief Compliance Officer

John Muir HealthJohn Muir HealthJohn Muir HealthJohn Muir Health

[email protected]@[email protected]@johnmuirhealth.com

Lynda Hilliard, MBA, CHCLynda Hilliard, MBA, CHCLynda Hilliard, MBA, CHCLynda Hilliard, MBA, CHC

Deputy Compliance OfficerDeputy Compliance OfficerDeputy Compliance OfficerDeputy Compliance Officer

University of CaliforniaUniversity of CaliforniaUniversity of CaliforniaUniversity of California

[email protected]@[email protected]@ucop.edu

Luanna Putney, PhD, CHCLuanna Putney, PhD, CHCLuanna Putney, PhD, CHCLuanna Putney, PhD, CHC

Director, Research ComplianceDirector, Research ComplianceDirector, Research ComplianceDirector, Research Compliance

University of CaliforniaUniversity of CaliforniaUniversity of CaliforniaUniversity of California

[email protected]@[email protected]@ucop.edu

Panel MembersPanel MembersPanel MembersPanel Members

Session Agenda Session Agenda Session Agenda Session Agenda

Section I: AMC Compliance Overview

Section II: Conflicts of Interest

Section III: AMC Billing Issues and Other Regulatory Issues

Section IV: Medical vs. Research Record

Summary and Q&As

AMC Compliance OverviewAMC Compliance OverviewAMC Compliance OverviewAMC Compliance Overview

Major Challenges Facing AMCs

� Healthcare Reform

� Government Focus

� Financial/Economic Issues

Top Compliance Risks

� Conflicts of Interest

� Government Funding: M/M, ARRA

� MR Issues – EMR, Privacy, Data Sharing

Definition of Definition of Definition of Definition of Conflict of InterestConflict of InterestConflict of InterestConflict of Interest

� Risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest

� Primary interests of medicine are to—

� Provide beneficial care to patients

� Conduct valid research

� Provide medical education

� Medical and pharma industry—

� Produce products that improve health

� Ensure a financial return to shareholders

� Doesn’t mean that judgment isisisis affected – only that it mightmightmightmight be

Issues in Clinical Trials & ResearchIssues in Clinical Trials & ResearchIssues in Clinical Trials & ResearchIssues in Clinical Trials & Research

� Walter Reed Medical Center orthopedic surgeon accused of falsifying research on bone-growth product by Medtronic

� Failed to disclose financial relationship with Medtronic

� AstraZeneca's Sex-for-Studies Seroquel Scandal

� AstraZeneca executive in charge of clinical research on Seroquel had sexual affairs with a researcher and a study writer, plaintiffs in a Florida lawsuit claim

� Pfizer to pay $75m after deaths of Nigerian children in drug trial experiment

� Massachusetts physician pleads guilty to faking published research for more than 12 years

Issues in Clinical Trials & Issues in Clinical Trials & Issues in Clinical Trials & Issues in Clinical Trials & ResearchResearchResearchResearch

� Ghostwriting - Merck employees preparing manuscripts touting Vioxx, sometimes in collaboration with medical publishing companies, then recruiting academic physicians to be the first authors

� Carle Cancer Center closed to new clinical trial enrollments after feds investigate

� Whistleblower claims numerous flaws in clinical trial protocols

� Cardiologist files qui tam suit against clinic, alleging pressure to use Medtronic products due to “substantial financial ties” with department chair

Conflicts of Interest inConflicts of Interest inConflicts of Interest inConflicts of Interest in…………

� Research

�Medical education

�Medical practice

�Medical associations

Sources of C

onflic

ts of

Interest

AMCs and Institutional AMCs and Institutional AMCs and Institutional AMCs and Institutional Financial ConflictsFinancial ConflictsFinancial ConflictsFinancial Conflicts

“Many leaders and administrators at AMCs are asking how scientific objectivity can be maintained considering the potentially compromising relationships that can ensue from gifts, grants, royalties, equity holdings, and business ownership – not only to individual investigators and clinicians, but also to academic institutions.”1

1Academic Medical Centers and Financial Conflicts of Interest, JAMA, February 13, 2008

AMCs and Financial AMCs and Financial AMCs and Financial AMCs and Financial ConflictsConflictsConflictsConflicts

“A conflict arises when the institution or a department, school, or subunit or an affiliated foundation or organization has a financial interest in a company that itself has a financial interest in a faculty research project.”1

1Academic Medical Centers and Financial Conflicts of Interest, JAMA, February 13, 2008

AMCs and Financial AMCs and Financial AMCs and Financial AMCs and Financial ConflictsConflictsConflictsConflicts

� US Government Accounting Office (GAO) and Association of American Medical Colleges (AAMC) urge universities to

� Disclose conflicts

� Manage conflicts

� Prohibit activities if necessary to protect public and the university

� Erect firewalls separating financial and research personnel

Human Research Protection Program Human Research Protection Program Human Research Protection Program Human Research Protection Program (HHRPs) and Institutional Conflicts(HHRPs) and Institutional Conflicts(HHRPs) and Institutional Conflicts(HHRPs) and Institutional Conflicts

� New AAHRPP (Association for the Accreditation of HRPP) Institutional Review Board (IRB) Accreditation Standard

� Requires HRPP policy re. institutional conflicts –

� Element I.6.A. : “The Organization has and follows written policies and procedures to identify, manage and minimize or eliminate financial conflicts of interest of the Organization that could influence the conduct of the research or integrity of the Human Research Protection Program.”

� Focuses on interests of Senior Officials and Organization’s interest in research Intellectual Property (IP).

Continuing Medical Education Continuing Medical Education Continuing Medical Education Continuing Medical Education (CME) Financing(CME) Financing(CME) Financing(CME) Financing

Testimony of Dr. Kopelow, ACCME, before US Senate 7/29/2009

American Medical Student AssociationAmerican Medical Student AssociationAmerican Medical Student AssociationAmerican Medical Student Association(AMSA)(AMSA)(AMSA)(AMSA)

� AMSA PharmFree Scorecard 2009 released on June 16, 2009

� 35 schools, or 23%, received an F

� 17 got a D

� 18 received a C

� 36 were graded B

� Only 9 schools received an A.

Research ShowsResearch ShowsResearch ShowsResearch Shows…………

� Interpersonal interactions can affect decision-making

� Gifts (regardless of value) can affect decision-making

� Disclosure of conflicts of interest, in and of itself, may not affect perception of bias and influence

� The public is concerned about conflicts of interest

Why Avoid Potential

Conflic

ts of In

terest?

The Downside of ConflictsThe Downside of ConflictsThe Downside of ConflictsThe Downside of Conflicts

�Overuse or misuse of drugs and devices

�Rising healthcare costs

�Patient quality and safety

�Protection of human subjects in research

�Credibility of medical and scientific research

�Violation of terms of grants or research contracts

The Downside of ConflictsThe Downside of ConflictsThe Downside of ConflictsThe Downside of Conflicts

� Potential for decreased public trust

� Fear of regulatory and legal action

� Scandals and negative media/PR

� Loss of respect in the medical and

academic community

� Loss of funding

Multiple, Inconsistent Multiple, Inconsistent Multiple, Inconsistent Multiple, Inconsistent StandardsStandardsStandardsStandards

� American Medical Association (AMA) Council on Ethics and Judicial Affairs (CEJA) Guidelines

� Institute of Medicine (IOM) recommendations

� American Academy of Continuing Medical Education (ACCME) Standards for Commercial Support

� AMSA PharmFree

� AdvaMed Code

� PhRMA Code

� Individual AMC polices

� Legal/Regulatory requirements

� etc….

AMCs & Organizatio

ns Try to

Respond, b

ut…

AMA AMA AMA AMA –––– Council on Ethical and Judicial Council on Ethical and Judicial Council on Ethical and Judicial Council on Ethical and Judicial Affairs (CEJA) Affairs (CEJA) Affairs (CEJA) Affairs (CEJA) –––– CME ReportCME ReportCME ReportCME Report

� Relationships with industry can offer enormous benefit to the profession and to patients

� Commercial funding for professional education can pose significant ethical challenges

� It is ethically preferable ethically preferable ethically preferable ethically preferable that CME providers accept funding only from sources that have no direct financial interest in a physician’s clinical recommendations

IOM IOM IOM IOM –––– COI in Medical Research, COI in Medical Research, COI in Medical Research, COI in Medical Research, Education & PracticeEducation & PracticeEducation & PracticeEducation & Practice

� “Troubling” interactions between industry and medicine may undermine public confidence

� Companies and investigators not publishing negative results from industry-sponsored clinical trials;

� Physicians and researchers failing to disclose substantial payments from industry

� Settlements between federal prosecutors and industry related to illegal payments or gifts to physicians

IOM Report and RecommendationsIOM Report and RecommendationsIOM Report and RecommendationsIOM Report and Recommendations

� Develop uniform disclosure standards

� National reporting program that requires industry to publicly report all payments

� Researchers should not conduct research in which they have a financial interest

� CME that is free of industry influence

IOM Report and RecommendationsIOM Report and RecommendationsIOM Report and RecommendationsIOM Report and Recommendations

� AMCs and teaching hospitals should prohibit faculty from accepting gifts, making presentations that are controlled by industry, claiming authorship for ghostwritten publications, consulting for greater than FMV

� Should restrict visits by industry salespeople, limit use of drug samples, and prohibit acceptance of meals and gifts from vendors

ACCME GuidelinesACCME GuidelinesACCME GuidelinesACCME Guidelines

� CME is not influenced by industry according to ACCME’s chief executive

� Industry funding for CME totaled more than $1 billion in 2008

� Enhanced surveillance and monitoring activities to ensure compliance

AMSAAMSAAMSAAMSA

� Future Physicians Develop Conflict of Interest Curriculum for Nation’s Academic Medical Centers (November 2009)

� recommendations for a model “PharmFree” curriculum for medical education

Harvard Teaching Hospitals Harvard Teaching Hospitals Harvard Teaching Hospitals Harvard Teaching Hospitals Cap Outside PayCap Outside PayCap Outside PayCap Outside Pay

� Harvard Medical School hospitals imposes restrictions on outside pay for senior officials on the boards of pharmaceutical or biotechnology companies (January 2010)

� Conflict-of-interest rules at the institution go further than those of any other academic medical center in restricting outside pay from drug companies

� Speaker’s fees from drug companies for any employee, including nearly 8,000 with Harvard faculty appointments, also forbidden

New Stanford Medical Center Policy New Stanford Medical Center Policy New Stanford Medical Center Policy New Stanford Medical Center Policy limits drug company access and giftslimits drug company access and giftslimits drug company access and giftslimits drug company access and gifts

� Prohibits physicians from accepting industry

gifts of any size, including drug samples,

anywhere on the medical center campus or at

off-site clinical facilities where they may

practice

� Bans pharmaceutical, bio-device and related

industry representatives from patient care

areas and medical school facilities except for

in-service training on devices and equipment

and by appointment only

� Allows industry support of educational

activities only under well-regulated conditions.

Conflicts of Interest in Conflicts of Interest in Conflicts of Interest in Conflicts of Interest in Medical Association Groups?Medical Association Groups?Medical Association Groups?Medical Association Groups?

� Senator Charles Grassley sent letters to the American Medical Association, the American Cancer Society and 31 other disease and medical advocacy organizations asking them to provide details about the amount of money that they and their directors receive from drug and device makers

� Earlier letter to National Alliance on Medical Illness (NAMI) revealed that over half of income comes from pharma

Legislative & Judiciary Response

Conflict of Interest in Medical SchoolsConflict of Interest in Medical SchoolsConflict of Interest in Medical SchoolsConflict of Interest in Medical Schools

� Senator Chuck Grassley asked 23 medical schools for information about their policies for conflicts of interest and requirements for disclosure of financial relationships between faculty members and the pharmaceutical industry (June 2009)

Have You Gotten Your Letter Yet?Have You Gotten Your Letter Yet?Have You Gotten Your Letter Yet?Have You Gotten Your Letter Yet?Top Psychiatrist DidnTop Psychiatrist DidnTop Psychiatrist DidnTop Psychiatrist Didn’’’’t Report Drug Makerst Report Drug Makerst Report Drug Makerst Report Drug Makers’’’’ Pay Pay Pay Pay

Sign in to RecommendSign in to RecommendSign in to RecommendSign in to Recommend

By By By By GARDINER HARRISGARDINER HARRISGARDINER HARRISGARDINER HARRIS

October 3, 2008 October 3, 2008 October 3, 2008 October 3, 2008

One of the nationOne of the nationOne of the nationOne of the nation’’’’s most influential s most influential s most influential s most influential psychiatristspsychiatristspsychiatristspsychiatrists earned more than $2.8 million in consulting earned more than $2.8 million in consulting earned more than $2.8 million in consulting earned more than $2.8 million in consulting arrangements with drug makers from 2000 to 2007, failed to reporarrangements with drug makers from 2000 to 2007, failed to reporarrangements with drug makers from 2000 to 2007, failed to reporarrangements with drug makers from 2000 to 2007, failed to report at least $1.2 million of t at least $1.2 million of t at least $1.2 million of t at least $1.2 million of that income to his university and violated federal research rulethat income to his university and violated federal research rulethat income to his university and violated federal research rulethat income to his university and violated federal research rules, according to documents s, according to documents s, according to documents s, according to documents provided to Congressional investigators.provided to Congressional investigators.provided to Congressional investigators.provided to Congressional investigators.

The psychiatrist, Dr. Charles B. Nemeroff of The psychiatrist, Dr. Charles B. Nemeroff of The psychiatrist, Dr. Charles B. Nemeroff of The psychiatrist, Dr. Charles B. Nemeroff of Emory UniversityEmory UniversityEmory UniversityEmory University, is the most prominent figure to , is the most prominent figure to , is the most prominent figure to , is the most prominent figure to date in a series of disclosures that is shaking the world of acadate in a series of disclosures that is shaking the world of acadate in a series of disclosures that is shaking the world of acadate in a series of disclosures that is shaking the world of academic medicine and seems demic medicine and seems demic medicine and seems demic medicine and seems likely to force broad changes in the relationships between doctolikely to force broad changes in the relationships between doctolikely to force broad changes in the relationships between doctolikely to force broad changes in the relationships between doctors and drug makers. rs and drug makers. rs and drug makers. rs and drug makers.

. . . . .. . . . .. . . . .. . . . .

The Congressional inquiry, led by Senator The Congressional inquiry, led by Senator The Congressional inquiry, led by Senator The Congressional inquiry, led by Senator Charles E. GrassleyCharles E. GrassleyCharles E. GrassleyCharles E. Grassley, Republican of Iowa, is , Republican of Iowa, is , Republican of Iowa, is , Republican of Iowa, is systematically asking some of the nationsystematically asking some of the nationsystematically asking some of the nationsystematically asking some of the nation’’’’s leading researchers to provide their conflicts leading researchers to provide their conflicts leading researchers to provide their conflicts leading researchers to provide their conflict----ofofofof----interest disclosures, and Mr. Grassley is comparing those documeinterest disclosures, and Mr. Grassley is comparing those documeinterest disclosures, and Mr. Grassley is comparing those documeinterest disclosures, and Mr. Grassley is comparing those documents with records of actual nts with records of actual nts with records of actual nts with records of actual payments from drug companies. The records often conflict, sometipayments from drug companies. The records often conflict, sometipayments from drug companies. The records often conflict, sometipayments from drug companies. The records often conflict, sometimes starkly.mes starkly.mes starkly.mes starkly.

Fall Out Fall Out Fall Out Fall Out

� Welcome to “Under the Microscope”

� Media, federal agencies, accrediting agencies, regulatory committees, prime contractors/awardees

� Formulating your response

� What you don’t know will hurt you – fact gathering and document review

� Response team -- affected units; subject matter experts; legal counsel; communications, etc.

� Faculty involvement in response

Fall OutFall OutFall OutFall Out

� NIH and other Government Sponsors

� Policy review

� Anything else we need to know about?

� Special reporting conditions

� Making instant changes to processes, procedures and forms

� Is everything you’re submitting in accordance with all new requirements? (BTW they’re checking).

� Waiting for the next shoe to drop, or as Britney says “Oops, I did it again . . . “

Physician Payment Sunshine ActPhysician Payment Sunshine ActPhysician Payment Sunshine ActPhysician Payment Sunshine Act

� Senate Finance Committee Chairman Max Baucus

� $10 per event or $100 cumulative payment quota

� Requires reporting of payments to physicians, group practice or hospitals with a medical residency program

� Does not include a small business exemption

Orthopedic Firms Reveal Orthopedic Firms Reveal Orthopedic Firms Reveal Orthopedic Firms Reveal Payments in SettlementPayments in SettlementPayments in SettlementPayments in Settlement

� Four of the nation's five largest makers of artificial hips and knees paid $311 million in 2007 to settle a U.S. Department of Justice investigation into consulting fees paid to doctors.

� As a condition of the settlement, the companies must post the names and locations of consultants or institutions, and annual payments made

Private Sunshine Private Sunshine Private Sunshine Private Sunshine –––– Drug Co. Drug Co. Drug Co. Drug Co. Payment PostingPayment PostingPayment PostingPayment Posting

� Voluntary decision by drug companies to post speaker payments to physicians on website

� Merck, Lilly, GSK

� Duty to check and compare with reports made to COI Office?

Accuracy of Physician COI DisclosuresAccuracy of Physician COI DisclosuresAccuracy of Physician COI DisclosuresAccuracy of Physician COI Disclosures

� New England Journal Of Medicine (NEJM), October 2009

� Compared physician disclosure statements at annual meeting to manufacturer’s reported amounts

� Overall rate of disclosure = 71.2%

� Most common reason for non disclosure was payment was unrelated to topic of presentation at meeting

OIG Reports of FDA (2009) and OIG Reports of FDA (2009) and OIG Reports of FDA (2009) and OIG Reports of FDA (2009) and NIH (2008) DisclosuresNIH (2008) DisclosuresNIH (2008) DisclosuresNIH (2008) Disclosures

� Food and Drug Administration (FDA)Food and Drug Administration (FDA)Food and Drug Administration (FDA)Food and Drug Administration (FDA)

� FDA cannot determine whether sponsors have submitted financial information for all clinical investigations

� 42% of FDA approved marketing applications missing financial information

� National Institutes of Health (NIH)National Institutes of Health (NIH)National Institutes of Health (NIH)National Institutes of Health (NIH)

� No accurate count of financial COI reports for FY 2004-2006

� Most COI reports do not state the nature of the conflict

Goals of Disclosure in ResearchGoals of Disclosure in ResearchGoals of Disclosure in ResearchGoals of Disclosure in Research1111

� Provide potential research recipients with information that may be material to their decision to participate

� Respond to perceived regulatory requirements or protect against legal threats

� Deter investigators and institutions from having significant conflicts of interest

1Policies of Academic Medical Centers for Disclosing Financial Conflicts of Interest to Potential Research Participants, Association of American Medical Colleges, 2006

Informed Consent in Informed Consent in Informed Consent in Informed Consent in ResearchResearchResearchResearch----RequirementsRequirementsRequirementsRequirements

� Research subjects must

� enter a study voluntarily;

� be informed about risks and benefits;

� understand the difference between experiment and treatment;

� understand the information provided

Goals of Disclosure in Goals of Disclosure in Goals of Disclosure in Goals of Disclosure in ResearchResearchResearchResearch1111

� Review of COI disclosures from 120 AMCs reveal that “the majority of the AMCs’ policies were most consistent with the goal of avoiding legal liability”

1Policies of Academic Medical Centers for Disclosing Financial Conflicts of Interest to Potential Research Participants, Association of American Medical Colleges, 2006

Preventing or Managing Preventing or Managing Preventing or Managing Preventing or Managing ConflictsConflictsConflictsConflicts

� Policy tune-up

�Make sure everyone knows the rules – education is key

� Watch out for conflicting policies

� Encourage transparency

�War Stories

Questions & AnswersQuestions & AnswersQuestions & AnswersQuestions & Answers

Clinical Trial Clinical Trial Clinical Trial Clinical Trial Billing Billing Billing Billing & Other & Other & Other & Other

Reimbursement Reimbursement Reimbursement Reimbursement IssuesIssuesIssuesIssues

What is Clinical Trial Billing?

� Synonyms:

� Research patient billing

� Clinical research billing

Clinical Trial BillingClinical Trial BillingClinical Trial BillingClinical Trial BillingWhat Has Given Rise to the Focus on this What Has Given Rise to the Focus on this What Has Given Rise to the Focus on this What Has Given Rise to the Focus on this Issue?Issue?Issue?Issue?

� Federal payors (including Medicare and Medicaid) are on the

look out for billing irregularities and inaccuracies.

� False claims on clinical trials billing have resulted in major

fines and unwanted scrutiny.

� DHHS’s OIG’s draft research compliance program guidance

specifically highlights billing as an area of risk that should

be managed through a formal compliance process.

� Double-, over-, and irregular-billing practices have been the

subject of numerous OIG and DOJ investigations.

� Many research organizations have lost money on research

studies. NOTE: In part, this is because they are not billing

for all routine care services and they are not making

sponsors accountable for non-routine care charges.

� Hospitals and health systems that serve as “performance sites” for research either have manual, inefficient revenue cycles

OR

their highly automated systems are unable to be easily modified in order to flag or identify research participants and reroute their bills.

� AMCs, hospitals, and health systems have “deep pockets” so investigations tend to focus more on them than PIs


� It does not matter if an organization is a small or medium sized community hospital, a large AMC, or a health system. The risks, drivers and sensitivities on this issue are similar. The questions are the same.

� Who should be accountable?

� What is the best way to do this from a process and work flow perspective?

� How do I limit the impact of implementing new work flow so that my bottom line isn’t affected?


Major Cases Have Brought the Major Cases Have Brought the Major Cases Have Brought the Major Cases Have Brought the Issue to LightIssue to LightIssue to LightIssue to Light

� The settlement at Rush resulted in considerable undesirable attention for this academic medical center.

� Results (financial):

� First settlement that cited the National Coverage Decision (NCR) on the Routine Costs of Clinical Trials as the main doctrine that was violated.

� Target of investigation was oncology trials and specific allegations of inappropriate billing of conventional care items.

� Rush fined and had to repay $1 million.

� Rush signed a three-year Certification of Compliance Agreement. Rush avoided a CIA in part, by voluntarily disclosing the overpayments it received.

Major Cases Have Brought the Major Cases Have Brought the Major Cases Have Brought the Major Cases Have Brought the Issue to LightIssue to LightIssue to LightIssue to Light

� Results (operational):

� Establishment of central office for research patient billing.

� All clinical trials must have “Medicare coverage analysis” and a “billing plan”.

� Considerable addition of policies, training, and procedures.

� New forms to assist work flow.

� Major auditing and monitoring initiative.

� The settlement case at UAB was the outcome of a nine year review of billing irregularities and improprieties. Effort reporting was also an issue.

� Results (financial):� Repayment of $3.39 million of the more than $3.5 billion the government paid UAB during the investigated period (i.e., ’96 thru ’04) for healthcare services and research funding.

� Results (operational);� Accounting procedures overhauled.� New clinical trials management system implemented (at considerable cost).

� Effort reporting training and operations completely redesigned.

� Clinical trials routed through central authority for review

of financials and billing plan.

The good news is that the number of cases other The good news is that the number of cases other The good news is that the number of cases other The good news is that the number of cases other than Rush and UAB is limited.than Rush and UAB is limited.than Rush and UAB is limited.than Rush and UAB is limited.

Major Cases Have Brought the Issue Major Cases Have Brought the Issue Major Cases Have Brought the Issue Major Cases Have Brought the Issue to Lightto Lightto Lightto Light

Major ChallengesMajor ChallengesMajor ChallengesMajor Challenges

� Compliant management of clinical trial billing requires a broad understanding of many fragmented, disconnected processes and technology.

� Billing is a discrete event. But, an appreciation for all the other “events”that take place before and after billing is critical.

� Few persons in an organization have adequate authority or a thorough awareness of the full process continuum.


� The likelihood of correctly following through on both debiting a study account and billing some other third-party (insurance, patient, Medicare, etc.) depends on considerable investments in operations, financial management, and compliance oversight.

� In the absence of suitable IT systems, investmentsmeans deploying enough people to own the process.

� In most organizations the variety of stakeholder leads to a situation where many of them have varied, often misaligned priorities, time, or interest in seeing the process through.


� When clinical activities performed strictly for research purposes get inadvertently billed to the patient or insurer (rather than a grant/study account) there are usually four main reasons why:

� Technological errorsTechnological errorsTechnological errorsTechnological errors: A “research flag” (i.e., unique study number, a letter on an encounter form, or some other indicator) was not recognized by information systems.

� Human errorsHuman errorsHuman errorsHuman errors: A study number was never placed on the encounter form and/or no one performing charge capture was informed.


�Most common reasons for failure (continued):

– Check in personnel are unaware of research participants.

– Technicians in ancillary service areas are unaware.

– PI and person negotiating CTA are not in communication. Leads to PI thinking something is billable to payor but it may be for item negotiated for payment from sponsor leading to inadvertent double dip.

� TrainingTrainingTrainingTraining: Inadequate explanation of expectations, use of forms, work flow.

– Policies not updated

– Policies exist without accompanying SOP

– Training not regularly updated


�Most common reasons for failure (continued):

� Awareness: Awareness: Awareness: Awareness: Because research related care can take place in so many care settings (and, often concurrently with routine services), ensuring that those at every point of entry in your facility know what to do is unlikely in the absence of a coordinated strategy. Must know the following:

� Who is the patient (research patient or not)?

� What is the name of their study?

� What episode of care, per the protocol, are they receiving?

� If an emergency, how do you ensure that EMTs and ED docs know a patient’s research status?

� Are processes highly manual or do you have a good electronic system?

� Are roles and responsibilities clearly stated and understood?

� Annual training activity on billing, study accounts, coverage, etc.?

� For those who conduct coverage analysis, is there specific training tailored for Pis? Coordinators? Billing personnel?

� Do sponsor contracts/agreements clearly state which patient care costs are covered? Is there adequate access for those who need to know?

� Are sponsors being billed and payments collected (and credited to study accounts) in a timely manner?

Clinical Trial BillingClinical Trial BillingClinical Trial BillingClinical Trial BillingSynchronous Work Flow is KeySynchronous Work Flow is KeySynchronous Work Flow is KeySynchronous Work Flow is Key

Charge

Segregation

Charge

Capture

Registration &

Scheduling

Enrollment &

Informed

Consent

IRB

ApprovalContracting

Budgeting

Billing Plan

Coverage

Review

Feasibility

Analysis

Vetting

Compliant

Billing

From the standpoint of optimizing process, it is vital to spend time early on to plan for potentially challenging

billing issues.

Conducting a Clinical Conducting a Clinical Conducting a Clinical Conducting a Clinical Trials Trials Trials Trials

Billing AssessmentBilling AssessmentBilling AssessmentBilling Assessment

Auditing Clinical Trials BillingAuditing Clinical Trials BillingAuditing Clinical Trials BillingAuditing Clinical Trials Billing

In assessing one’s own process for managing

clinical trials billing, there are numerous

questions asked and areas that are reviewed.

� 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?


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 various research

patient scenarios?


Operations:Operations:Operations:Operations:

� Charge Capture

�Who is pushing the buttons?

�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?



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? Is it crafted using 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?


Financial Management:Financial Management:Financial Management:Financial Management:

� 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? Lock box? Who is accountable?

� Professional Fees

�Are these being included in study budgets?

�Being billed at all? Debited against the study budget?

Compliance Management:Compliance Management:Compliance Management: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?


Compliance Management (continued):Compliance Management (continued):Compliance Management (continued):Compliance Management (continued):

� 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?



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?


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?

Strategies for Strategies for Strategies for Strategies for Enhancing Compliance Enhancing Compliance Enhancing Compliance Enhancing Compliance in Clinical Trials Billingin Clinical Trials Billingin Clinical Trials Billingin Clinical Trials Billing

Clinical Trials BillingClinical Trials BillingClinical Trials BillingClinical Trials BillingStrategies for Enhancing ComplianceStrategies for Enhancing ComplianceStrategies for Enhancing ComplianceStrategies for Enhancing Compliance

� Standardization and Central Support Services

� Whereas many departments used to “own” these processes, many organizations are creating Clinical Trials Offices where many of the critical pre-study and research initiation services are provided.

�Regulatory coordination

�MCA development

�Research charge master oversight

�Budget development

• Contracting / negotiation

• Sponsor invoicing

• Cash management

• Bill review / scrubbing


� Standardization and Central Support Services

� Other centralized services reside with the compliance office.

�Research compliance specialists

�Training & education

�Auditing & monitoring

� Reducing disparate approaches to budgeting, training, and planning helps to ensure that the “performance site” has a stake and some control in helping deliver a consistent approach to research taking place on its premises.

� Many organizations have created a “fee for service”model to perform these services.


� Implementation of clinical trials management systems Implementation of clinical trials management systems Implementation of clinical trials management systems Implementation of clinical trials management systems (CTMS)(CTMS)(CTMS)(CTMS)

� Many software and hardware vendors have good systems that can handle key aspects of the research “life cycle” or “continuum”.

� Costs remain high.

� Implications for a major change in work flow and culture.

� Some systems do different things. Finding one that can easily work with your billing, schedule, and registration systems is often difficult.


� Realigning organizational designsRealigning organizational designsRealigning organizational designsRealigning organizational designs

� Centralizing coordinators.

� Establishing a chief research officer.

� Establish a deputy compliance officer for research

� Carving out clinical research from traditional pre-and post- award activities associated with bench/basic research.

� Separate CTO for commercial sponsors versus federal grants.


� Training

� Make it mandatory and a routine part of annual education expectations.

� Dedicate FTEs to coordinate programming.

� All stakeholders are accountable for training. Tone at the top implies that organizational leadership participate also.

� Requiring development and use of a Medicare Coverage Analysis at the outset of the planning for any potential trial to be hosted by your organization.

� The Rush case catalyzed many organizations to insist upon MCAs as the lynchpin for study initiation.

� When done properly and used as intended, an MCA can improve revenue for research.


� Medicare Coverage Analyses (con’t)

� By identifying early on what items and services can be billed to a 3rd party (patient, Medicare, private payors, etc.), MCAs can improve an organization’s ability to better negotiate payments from sponsors.

� MCAs can help in many, meaningful ways

�Determines if a trial is qualifying.

�During pre-award it helps keep the budget, ICF, contract and other key documents consistent.

�During post-award it can be useful as a resource for scheduling and registration.

�Clarifies items that are provided by the study sponsor or promises free of charge to the research participant.

�Can help enable allocation of fixed fee revenue to other non-covered services.

�Demonstrates a good faith effort of trying to determine billable vs. non-billable tests and procedures. This could be valuable in the event of an audit.


� Medicare Coverage Analyses (con’t)

� Other Uses

� Providing Patient Access with a copy of an MCA

(with appropriate training for how to read the

document) can assist in obtaining clearance from

3rd-party payors for the billing of routine care

charges in connection with a clinical trial.

� Providing charge capture or charge audit staff a

copy of the MCA (with appropriate training for how

to read the document) can help assure research

charges are not billed to a 3rd-party payor.

� To the extent that a bill hold is in place for

research participant’s bills, an MCA can be useful

to patient financial services staff. It helps to

simplify information and hopefully limit confusion

over what is billable and what is not.

Other Options for Helping Other Options for Helping Other Options for Helping Other Options for Helping More Compliantly Manage More Compliantly Manage More Compliantly Manage More Compliantly Manage

Clinical Trials Clinical Trials Clinical Trials Clinical Trials

Compliant Clinical TrialsCompliant Clinical TrialsCompliant Clinical TrialsCompliant Clinical TrialsImportant Points to RememberImportant Points to RememberImportant Points to RememberImportant Points to Remember–––– PRE STUDYPRE STUDYPRE STUDYPRE STUDY

� Pre-Study Planning / Vetting

� Is there an adequate patient population?

� Do you have the facilities / capacity to run the study?

� Is the study at odds with your mission?

� Pre-Study Planning / Financial Evaluation

� What patient accrual is needed to achieve “break even”?

� Can you afford to do the trial? If likely to result in a loss, is it worth it strategically?

� Does the study cover its costs?

� Will the department chair of the PI sign a “promise to pay”document indicating that it will cover any losses on the study?

� Are IRB fees, IRB annual renewal fees, pharma fees, document storage fees, training, screen failure, FDA audit costs all captured and/or accounted for?

� Is the MCA done prior to budgeting?

� Is the appropriate effort, overhead, and fringe included?

Compliant Clinical TrialsCompliant Clinical TrialsCompliant Clinical TrialsCompliant Clinical TrialsImportant Points to Remember Important Points to Remember Important Points to Remember Important Points to Remember –––– IN STUDYIN STUDYIN STUDYIN STUDY

RegistrationRegistrationRegistrationRegistrationAppointment Appointment Appointment Appointment Request & Request & Request & Request & SchedulingSchedulingSchedulingScheduling

Charge Charge Charge Charge EntryEntryEntryEntry

Charge Charge Charge Charge CaptureCaptureCaptureCapture

BillingBillingBillingBilling

- 2 registrations

- 1 registration (multiple payor codes or visit level flag)

- 1 registration with patient level flag (implies need to implement bill hold)

- Attach “R” to encounter specific identifier fields

- Distinct appt. request forms

- Distinct (i.e., color coded, etc.) encounter forms

- Note an “R” or “standard” when documenting encounter

- Modify CDM to include research specific charges

- Create research CDM

- Assure research charges are captured against a designated research account

- Perform a manual, back-end charge review (i.e., bill hold) prior to dropping a bill. Use MCA as reference document.

Study account debited Study account debited Study account debited Study account debited with researchwith researchwith researchwith research----related related related related

tests & procedurestests & procedurestests & procedurestests & procedures....

3rd party payors are only 3rd party payors are only 3rd party payors are only 3rd party payors are only billed for conventional billed for conventional billed for conventional billed for conventional

care tests & procedurescare tests & procedurescare tests & procedurescare tests & procedures....andandandand

What are the desired outcomes?What are the desired outcomes?What are the desired outcomes?What are the desired outcomes?


In general at least 4 major strategies for making this happen have emerged

CTMS

� Requires that CTMS (or a patient registry) can interface with a billing system to catch episodes of care prior to billing that may have included research (non-billable to a 3rd party payor) events.

� Charges routed either to a bill review queue or a separate research billing system.

Duplicate registrations

� Same patient registered twice using two different plan codes.

� May complicate registration systems to have two of the same person present.


In general at least 4 major strategies for making this happen have emerged

Patient-level “flag”

� Research participants are noted in registration systems by their flag.

� All tests and procedures for that patient drop in to a queue where the individual charges are reviewed and compared to an MCA.

Visit-level “flag”

� Each visit is flagged during scheduling and Billing office gets a pre-notification.

� Patient’s charges put on temporary hold (until visit concludes).

� Charges for that visit are reviewed through a manual bill review process.

Other Reimbursement Issues

Supervision IssuesSupervision IssuesSupervision IssuesSupervision Issues

� Incident-to supervision in hospital outpatient departments

� Physicians at Teaching Hospitals (PATH) rules for resident supervision

IncidentIncidentIncidentIncident––––to Supervisionto Supervisionto Supervisionto Supervision

Physician Supervision LevelsPhysician Supervision LevelsPhysician Supervision LevelsPhysician Supervision Levels

� General supervision means the procedure is furnished under the physician’s overall direction and control, but the physician’s presence is not required during the performance of the procedure. Under general supervision, the training of the non-physician personnel who actually performs the procedure and the maintenance of the necessary equipment and supplies are the continuing responsibility of the physician.

� Direct supervision in the office setting means the physician must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed.

� Personal supervision means a physician must be in attendance in the room during the performance of the procedure.


� CMS restatements and clarification of provider-based outpatient supervision requirements for diagnostic and therapeutic services

� Direct supervision required for off-campus provider based clinics


� Supervision “on the hospital campus”

� “For services furnished in the hospital or in an on-campus outpatient department of the hospital, “direct supervision” means that the physician or non-physician practitioner must be present on the same campus and immediately available to furnish assistance and direction throughout the performance of the procedure..“

� No NPP’s for cardiac rehab, pulmonary rehab


� Supervision “on the hospital campus”

� "This means that the physician or nonphysician

practitioner must be prepared to step in and

perform the service, not just to respond to an

emergency. This includes the ability to take over

performance of a procedure and, as appropriate

to both the supervisory physician or

nonphysician practitioner and the patient, to

change a procedure or the course of treatment

being provided to a particular patient."

PATH SupervisionPATH SupervisionPATH SupervisionPATH Supervision

� Services furnished in teaching settings are paid under the Medicare Physician Fee Schedule (MPFS) if the services are:

� Personally furnished by a physician who is not a resident;

� Furnished by a resident when a teaching physician is physically present during the critical or key portions of the service; or

� Furnished by residents under a primary care exception within an approved Graduate Medical Education (GME) Program.


� Kaiser California (December 2009)

� Paid $3,752,000 under voluntary self disclosure protocol

� Services performed by residents without the presence of teaching physicians

� University Pediatricians Detroit( December 2009)

� Paid $92,000 under voluntary self disclosure protocol

� Teaching physician failed to supervise fellows

� Use of preprinted, pre-signed forms


� LSU-Shreveport (July 2009)

� Paid $700,000 to settle qui tam suit

� Numerous teaching physicians in the orthopedic department falsely claimed to have participated in orthopedic surgery cases performed by residents

� Government claimed teaching physicians were not present as required

Stark/AntiStark/AntiStark/AntiStark/Anti----kickbackkickbackkickbackkickback

� Safe Harbor in Stark for AMC’s

� Designated health services (DHS) furnished by an academic medical center are excepted from the Stark Law’s prohibition on self-referrals if the referring physician:

� is a bona fide full-time or substantial part-time employee of a component of the academic medical center;

� is licensed to practice medicine in the state;

�has a bona fide faculty appointment at the affiliated medical school; and

�provides either substantial academic or substantial clinical teaching services for which the faculty member is compensated as part of his or her employment relationship

� No corresponding Anti-kickback safe harbor

Stark/AntiStark/AntiStark/AntiStark/Anti----kickbackkickbackkickbackkickback

� University of Medicine and Dentistry New Jersey (UMDNJ)

� Paid over $8 million to settle kickback case related to cardiology program

�Sham teaching, research and coverage contracts

�Double damages on all improper referrals to UMDNJ

� DOJ also pursed claims against eleven of the cardiologists

�nine settled $30,000 to $1.4 million

Consultation CodesConsultation CodesConsultation CodesConsultation Codes

� Inpatient and outpatient consultation codes no longer recognized by Medicare

� Use E&M codes instead

� RVU’s increased 6% (0.3% for hospital and nursing facility visits) to compensate for loss of revenue

� Use AI modifier to distinguish principal physician of record E&M from consulting specialists E&M

Graduate Medical Education (GME) Graduate Medical Education (GME) Graduate Medical Education (GME) Graduate Medical Education (GME) & Indirect Medical Education (IME)& Indirect Medical Education (IME)& Indirect Medical Education (IME)& Indirect Medical Education (IME)

� D.C District Court orders Tulsa hospital to repay $2.5 million in IME

� IME FTE resident cap incorrectly calculated on 1999-2004 cost report

� Number used actually represented direct graduate medical education FTE count, not IME count

Questions & Discussion Questions & Discussion Questions & Discussion Questions & Discussion

Medical Medical Medical Medical vs. Research vs. Research vs. Research vs. Research

RecordRecordRecordRecord

Medical Record v. Research Record Medical Record v. Research Record Medical Record v. Research Record Medical Record v. Research Record

� Information regarding Patient’s Health Care (medical record) VS. Information kept regarding person’s participation in Research Study

� Overlap:

� Tests done for study that may also be used to determine treatment

� Records of study drug or device provided that is also relevant to patient’s care

LogisticsLogisticsLogisticsLogistics

� Old School – separate paper research record vs. separate paper medical record.

� New School – electronic research record with separate tabs for medical record and research record

� Breaking the glass

� Audit trail for both tabs

Safety IssuesSafety IssuesSafety IssuesSafety Issues

� Need for inclusion in medical record:

� Notice to providers that person is in a study and contact person for study information.

� Whether and what type of research intervention was received by subject.

� Results from labs and test, e.g., safety labs.

� Notice as to if and when patient withdraws from study.

Privacy IssuesPrivacy IssuesPrivacy IssuesPrivacy Issues

� Medical record access not confined to research personnel.

� Studies involving “sensitive information” – drug or alcohol use; infectious disease status; mental health; genetic information

� Recruitment – persons may not enroll in study involving sensitive issues, or in studies in which information collected and stored in medical record could affect insurability.

HIPAA & Research HIPAA & Research HIPAA & Research HIPAA & Research RecordsRecordsRecordsRecords

� Covered Entities

� Designated Record Sets

� Patient Access:

� Access to PHI may be temporarily suspended until end of research if PHI “was created or obtained by a covered health care provider in course of research that includes treatment” and patient agreed to denial at time of consent to research.

� Always consult the sponsor.

Informed Consent, Medical Informed Consent, Medical Informed Consent, Medical Informed Consent, Medical Records & Research Records Records & Research Records Records & Research Records Records & Research Records

� Research informed consent should let subjects know:

� what is in Medical Record

� what isn’t in Medical Record

�Example: Tests done solely for research purposes and not read for diagnostic or treatment purposes.

Certificates of Certificates of Certificates of Certificates of ConfidentialityConfidentialityConfidentialityConfidentiality

� Federal Certificates of Confidentiality

� What are they?

� What do they protect?

� What don’t they protect?

�Voluntary disclosures

� Do they cover information in medical records?

�NIH indicates yes – may want to include use for treatment as voluntary disclosure.

Psychotherapy NotesPsychotherapy NotesPsychotherapy NotesPsychotherapy Notes

� Psychotherapy Notes

� HIPAA Definition

�Requires that Notes be separate from medical record

� Psychotherapy notes in research record?

JCAHO JCAHO JCAHO JCAHO

� Inpatient studies

� What does JCAHO require:

� Hospital review of protocol

� Informed consent with elements set forth in Common Rule

� “Hospital keeps all information given to subject in the medical record or research file along with the consent forms.”[RI.01.03.05]

SummarySummarySummarySummary

Questions

and

Answers

academic aaccaaddeemmiicc academic medical …...academic aaccaaddeemmiicc academic medical centers...

Documents