10/4/2011

1

Clinical Research Compliance and Physician Responsibility

Kelly Willenberg, BSN, MBA, CHRCKaren Mottola, MA, CRCC, CPC

18 October 2011

� Review of Medicare guidelines Medicare guidelines Medicare guidelines Medicare guidelines for clinical research billing

� Summary of physician responsibility physician responsibility physician responsibility physician responsibility for clinical research compliance

� Awareness of impact of Healthcare Reform Healthcare Reform Healthcare Reform Healthcare Reform on physician practice research

10/4/2011

2

What every practice must know before it bills

The Centers for Medicare and Medicaid Services The Centers for Medicare and Medicaid Services The Centers for Medicare and Medicaid Services The Centers for Medicare and Medicaid Services (CMS) allows clinical research (CR) billing under (CMS) allows clinical research (CR) billing under (CMS) allows clinical research (CR) billing under (CMS) allows clinical research (CR) billing under certain circumstancescertain circumstancescertain circumstancescertain circumstances

◦ The circumstances are spelled out in the “Clinical Trials “Clinical Trials “Clinical Trials “Clinical Trials Policy”Policy”Policy”Policy” (CTP), a National Coverage Determination (NCD 310.1), instantiated in 2000, updated in 2007

◦ The CTP is based on the legal structure of Medicare

� Services to be billed must be:

� “reasonable and necessary”“reasonable and necessary”“reasonable and necessary”“reasonable and necessary”

� “routine”“routine”“routine”“routine” –some research-specific extensions

http://www.cms.hhs.gov/ClinicalTrialPolicies/http://www.cms.hhs.gov/ClinicalTrialPolicies/http://www.cms.hhs.gov/ClinicalTrialPolicies/http://www.cms.hhs.gov/ClinicalTrialPolicies/

44

10/4/2011

3

The CMS meaning of necessity is not equivalent to The CMS meaning of necessity is not equivalent to The CMS meaning of necessity is not equivalent to The CMS meaning of necessity is not equivalent to medical necessitymedical necessitymedical necessitymedical necessity

◦ CMS language: “items and services…reasonable and necessary for the diagnosis or treatment of illness or injury” Social Security Act 1862(a)(1)(a)

� Participant must be a patient suffering an illness or injury

� The service must be diagnostic or treatment

� The care must be reasonable and necessary

55

Special CMS meaning includes legal limits:Special CMS meaning includes legal limits:Special CMS meaning includes legal limits:Special CMS meaning includes legal limits:

The item(s) to be billed must:

� fall within a Medicare benefit categorybenefit categorybenefit categorybenefit category

• notnotnotnot be statutorily excludedstatutorily excludedstatutorily excludedstatutorily excluded

• notnotnotnot be prohibited by NCD or Local Coverage Determinationprohibited by NCD or Local Coverage Determinationprohibited by NCD or Local Coverage Determinationprohibited by NCD or Local Coverage Determination

The term more often employed in the CTP is “routine”

66

10/4/2011

4

For CRFor CRFor CRFor CR----related services, “routine care” may cover:related services, “routine care” may cover:related services, “routine care” may cover:related services, “routine care” may cover:

• All items that would have been covered in the absence of the research project, but also:

• An item that occurs solely for the purpose of provision of the investigational object

• An item that occurs to prevent or treat complications resulting from research participation

◦ \

77

In most cases, the investigational object is provided In most cases, the investigational object is provided In most cases, the investigational object is provided In most cases, the investigational object is provided by the study sponsor; in many, it must beby the study sponsor; in many, it must beby the study sponsor; in many, it must beby the study sponsor; in many, it must be

However:However:However:However:

• If the object under investigation is used as approved by the Food and Drug Administration (FDA) and is ordinarily treated by CMS as reasonable and necessary, it may be billed

• In other words, the object being investigated is• not experimental not experimental not experimental not experimental – it has FDA approvalFDA approvalFDA approvalFDA approval• notnotnotnot deemed to be “investigational” “investigational” “investigational” “investigational” by the FDA – approved for some use but not the one relevant to the study

• deemed to be “conventional care” “conventional care” “conventional care” “conventional care” by CMS

88

10/4/2011

5

The CTP introduces special qualifications for billing The CTP introduces special qualifications for billing The CTP introduces special qualifications for billing The CTP introduces special qualifications for billing what fits as “routine”what fits as “routine”what fits as “routine”what fits as “routine”

◦ One of the following deems a study as qualifying:

� FundingFundingFundingFunding from one of six federal offices federal offices federal offices federal offices (NIH, CDC, VA, DOD, AHRQ, or CMS)

� Support from a cooperative group cooperative group cooperative group cooperative group that is funded by one of the six federal offices named above

� Investigational New Drug Investigational New Drug Investigational New Drug Investigational New Drug (IND) assignment by the FDA

� INDINDINDIND----exemptionexemptionexemptionexemption (until self-certification is launched)

The CTP is not applicable to investigational The CTP is not applicable to investigational The CTP is not applicable to investigational The CTP is not applicable to investigational devicesdevicesdevicesdevices

◦ Refers to previous rules for device research

◦ Upshot: rules governing Investigation Drug Exemptions (IDE) issued by the FDA are operative:

� No coverage for Class A devices

� Potential coverage for Class B devicesClass B devicesClass B devicesClass B devices, but must seek Medicare Administrative Contractor Medicare Administrative Contractor Medicare Administrative Contractor Medicare Administrative Contractor (MAC) approvalapprovalapprovalapproval

� MACS differ in requirements by region

Medicare Benefit Policy Manual, Ch. 14

10/4/2011

6

1. CMS requires that research modifiers be appended 1. CMS requires that research modifiers be appended 1. CMS requires that research modifiers be appended 1. CMS requires that research modifiers be appended to to to to outpatientoutpatientoutpatientoutpatient bills:bills:bills:bills:

Q1Q1Q1Q1: routine items specified by research protocol, with the exception of the investigational object

Q0Q0Q0Q0: the investigational object

http://www.cms.gov/transmittals/downloads/R1418CP.pdfhttp://www.cms.gov/transmittals/downloads/R1418CP.pdfhttp://www.cms.gov/transmittals/downloads/R1418CP.pdfhttp://www.cms.gov/transmittals/downloads/R1418CP.pdf

2. CMS requires the CR diagnosis code in secondary 2. CMS requires the CR diagnosis code in secondary 2. CMS requires the CR diagnosis code in secondary 2. CMS requires the CR diagnosis code in secondary position, position, position, position, outpatient or inpatientoutpatient or inpatientoutpatient or inpatientoutpatient or inpatient, and CR condition , and CR condition , and CR condition , and CR condition code for code for code for code for Part APart APart APart A billingbillingbillingbilling

V70.7V70.7V70.7V70.7: participation in clinical research

Condition Code 30Condition Code 30Condition Code 30Condition Code 30: services provided to patients enrolled in a qualified clinical trial

http://www.cms.gov/transmittals/downloads/R1418CP.pdfhttp://www.cms.gov/transmittals/downloads/R1418CP.pdfhttp://www.cms.gov/transmittals/downloads/R1418CP.pdfhttp://www.cms.gov/transmittals/downloads/R1418CP.pdf

10/4/2011

7

Can you bill conventional care related to research if Can you bill conventional care related to research if Can you bill conventional care related to research if Can you bill conventional care related to research if the study is nonthe study is nonthe study is nonthe study is non----qualifying?qualifying?qualifying?qualifying?

◦ Non-qualifying studies are those that are neither a drug study nor an IDE-device study with special approval from the regional MAC nor federally funded or supported

◦ If items would have occurred outside of research participation – protocol specification of the item was not reason for decision of conventional care

◦ Seek legal advice, internal counsel and perhaps external

Human Subject Protection

Research Integrity

Conflict of Interest

FDA approval

Clinical research billing

10/4/2011

8

The federal code of regulations includes regulation The federal code of regulations includes regulation The federal code of regulations includes regulation The federal code of regulations includes regulation for protection of human subjectfor protection of human subjectfor protection of human subjectfor protection of human subject

◦ Clinical Research (CR) involves human subjects by definition

◦ Must receive Institutional Review Board (IRB) approval or exemption

http://ohsr.od.nih.gov/guidelines/45cfr46.htmlhttp://ohsr.od.nih.gov/guidelines/45cfr46.htmlhttp://ohsr.od.nih.gov/guidelines/45cfr46.htmlhttp://ohsr.od.nih.gov/guidelines/45cfr46.html

To protect human subjects, study must provide To protect human subjects, study must provide To protect human subjects, study must provide To protect human subjects, study must provide informed consentinformed consentinformed consentinformed consent

◦ Not just a document but a process of verifying that the participant understands risks of study

◦ Informed Consent is a PROCESS and must be documented

◦ Other essential IRB functions: periodic review of study, documentation of serious adverse events, proxy for FDA on IND exemptions, non-significant risk (NSR) designations

10/4/2011

9

The fabrication, falsification or plagiarism in The fabrication, falsification or plagiarism in The fabrication, falsification or plagiarism in The fabrication, falsification or plagiarism in proposing, performing, or reviewing research or in proposing, performing, or reviewing research or in proposing, performing, or reviewing research or in proposing, performing, or reviewing research or in reporting research resultsreporting research resultsreporting research resultsreporting research results

A “finding of research misconduct” “finding of research misconduct” “finding of research misconduct” “finding of research misconduct” requires:

• significant departure from accepted practices of the relevant research community

• intentional, knowing, or reckless commission of misconduct

• preponderance of evidence proves the allegation

To protect subjects and data, investigators must To protect subjects and data, investigators must To protect subjects and data, investigators must To protect subjects and data, investigators must disclose “conflicts of interest” and follow the disclose “conflicts of interest” and follow the disclose “conflicts of interest” and follow the disclose “conflicts of interest” and follow the regulation to eliminate or neutralize conflictregulation to eliminate or neutralize conflictregulation to eliminate or neutralize conflictregulation to eliminate or neutralize conflict

◦ A conflict of interest (COI) is not necessarily a bad thing – it is dangerous because it might interfere with objectivity

◦ New regulations from National Institutes of Health have tightened COI specifications

http://ori.hhs.gov/documents/42_cfr_parts_50_and_93_20http://ori.hhs.gov/documents/42_cfr_parts_50_and_93_20http://ori.hhs.gov/documents/42_cfr_parts_50_and_93_20http://ori.hhs.gov/documents/42_cfr_parts_50_and_93_2005.pdf05.pdf05.pdf05.pdf

10/4/2011

10

Any study involving an FDAAny study involving an FDAAny study involving an FDAAny study involving an FDA----regulated item, whether regulated item, whether regulated item, whether regulated item, whether approved or unapproved, must seek FDA assignment approved or unapproved, must seek FDA assignment approved or unapproved, must seek FDA assignment approved or unapproved, must seek FDA assignment or verify FDA exemptionor verify FDA exemptionor verify FDA exemptionor verify FDA exemption

◦ Use of drugs and devices as FDA-approved (indication, dosing, patient population, route of administration) are exempt from FDA application; IRB will approve

◦ Use of FDA-approved drug, when not used exactly as approved, may or may not require FDA application; IRB can assist, best practice to consult FDA

◦ Use of FDA-approved device, when not used exactly as approved, is often subject to more FDA scrutiny

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfmsearch.cfmsearch.cfmsearch.cfm

FDA scrutiny is heightening, especially for devicesFDA scrutiny is heightening, especially for devicesFDA scrutiny is heightening, especially for devicesFDA scrutiny is heightening, especially for devices

◦ The IRB may be able to provide Non-significant Risk (NSR) designation for device research

◦ Without NSR, FDA often requires Investigational Device Exemption (IDE) for collection of pre-market-approval data

◦ Some devices are able to be FDA-approved as Substantially Equivalent (SE) = 510(k) approvals; some need clinical data and will require IDE assignment

http://www.fda.gov/MedicalDevices/default.htmhttp://www.fda.gov/MedicalDevices/default.htmhttp://www.fda.gov/MedicalDevices/default.htmhttp://www.fda.gov/MedicalDevices/default.htm

10/4/2011

11

Clinical

Research

Billing

Coverage

Analysis and

Billing Plan

Budget,

Contract,

Consent

Subject

Registration

and Tracking

Third-party

Billing

Charge

Capture,

Segregation,

Research

Pricing

21

Audit

Study documents are interdependent; dictate logical Study documents are interdependent; dictate logical Study documents are interdependent; dictate logical Study documents are interdependent; dictate logical progression of eventsprogression of eventsprogression of eventsprogression of events

◦ Consent formConsent formConsent formConsent form, by federal requirement, must specify costs to participants; cannot be finalized until study agreement is finalized

◦ Study agreement/contract Study agreement/contract Study agreement/contract Study agreement/contract cannot be finalized before costs are fully projected

◦ Projection of costs requires analysis of perperperper----participant participant participant participant costscostscostscosts and projectprojectprojectproject----wide costs wide costs wide costs wide costs

◦ Per-participant costing requires coverage analysis for coverage analysis for coverage analysis for coverage analysis for insuranceinsuranceinsuranceinsurance----billablesbillablesbillablesbillables and research pricing for nonresearch pricing for nonresearch pricing for nonresearch pricing for non----billablesbillablesbillablesbillables

10/4/2011

12

Billing to insurance is overseen by coverage analysis; Billing to insurance is overseen by coverage analysis; Billing to insurance is overseen by coverage analysis; Billing to insurance is overseen by coverage analysis; billing to sponsor is overseen by research pricingbilling to sponsor is overseen by research pricingbilling to sponsor is overseen by research pricingbilling to sponsor is overseen by research pricing

◦ coverage analysis determines coverage analysis determines coverage analysis determines coverage analysis determines what can be billed to CMS, to other carriers; will follow CTP, carrier contracts

◦ all else must be billed to sponsorall else must be billed to sponsorall else must be billed to sponsorall else must be billed to sponsor

◦ CMS cannot be billed for anything that is customarily customarily customarily customarily provided by sponsorprovided by sponsorprovided by sponsorprovided by sponsor

◦ CMS providers cannot provide anything for fCMS providers cannot provide anything for fCMS providers cannot provide anything for fCMS providers cannot provide anything for free, unless determined by objective financial needs assessment

◦ research pricing research pricing research pricing research pricing should be no less than CMS rate for any no less than CMS rate for any no less than CMS rate for any no less than CMS rate for any sponsor and no more for government sponsorssponsor and no more for government sponsorssponsor and no more for government sponsorssponsor and no more for government sponsors

Once all financial planning is complete, investigator Once all financial planning is complete, investigator Once all financial planning is complete, investigator Once all financial planning is complete, investigator is responsible for process to achieve compliance is responsible for process to achieve compliance is responsible for process to achieve compliance is responsible for process to achieve compliance assuranceassuranceassuranceassurance

◦ All CMS guidelines CMS guidelines CMS guidelines CMS guidelines followed – bill only “routine” items; apply Q-modifiers, v70.7, condition code 30 as needed

◦ All nonnonnonnon----federal carriers’ guidelines federal carriers’ guidelines federal carriers’ guidelines federal carriers’ guidelines followed – doesn’t involve Qs, etc, but may involve research prohibitions

◦ Study is billed for all else Study is billed for all else Study is billed for all else Study is billed for all else at compliant prices – nothing free

◦ Sponsor payments do not exceed fair market valuefair market valuefair market valuefair market value

10/4/2011

13

Preparing for change in the near future

� Private Insurers cannot deny or limit coverage of routine patient costs for items and services furnished in connection with approved trial

� Cannot discriminate on basis of individual’s participation in trial

� Criteria remarkably similar to Medicare◦ i.e. “Routine Costs” = items typically covered absent a study and doesn’t include investigational item, items for data analysis, services inconsistent with standards of care etc.;◦ i.e. “Approved Trials” = Federally Funded Trial, IND application trials etc.

� Reference Section 2709

10/4/2011

14

Patient Protection And Affordable Care Act adds Patient Protection And Affordable Care Act adds Patient Protection And Affordable Care Act adds Patient Protection And Affordable Care Act adds “Coverage For Individuals Participating In Approved “Coverage For Individuals Participating In Approved “Coverage For Individuals Participating In Approved “Coverage For Individuals Participating In Approved Clinical Trials,” effective 2014, to Public Health Clinical Trials,” effective 2014, to Public Health Clinical Trials,” effective 2014, to Public Health Clinical Trials,” effective 2014, to Public Health Services Act (PHSA)Services Act (PHSA)Services Act (PHSA)Services Act (PHSA)

� private insurers cannot deny or limit coverage cannot deny or limit coverage cannot deny or limit coverage cannot deny or limit coverage of routine patient costs for items and services furnished in connection with approved CR

� cannot discriminate cannot discriminate cannot discriminate cannot discriminate on basis of individual’s CR participation

� criteria similar to CTP specificationsCTP specificationsCTP specificationsCTP specifications:◦ Routine Costs = items typically covered absent a study and doesn’t include investigational item, items for data analysis, services inconsistent with standards of care, etc.;◦ Approved Trials = federally funded CR, IND assignment, etc.

� insurer can require subjects to use “inLnetwork”“inLnetwork”“inLnetwork”“inLnetwork” providers that are investigators, if they will accept the subject

� includes “out“out“out“out----ofofofof----state” state” state” state” providers

◦ But doesn’t change outLofLnetwork benefits (i.e. subjects must pay outLofLnetwork rates if provided…If not, they will have to pay out-of-pocket)

� additional criteria: “eligible to participate…according to the trial protocol…”

� unlike CMS, limited to clinical trials of “cancer or other lifeLthreateninglifeLthreateninglifeLthreateninglifeLthreatening disease or condition”

10/4/2011

15

� Kelly Willenberg is President of Synergism, LLC, an Kelly Willenberg is President of Synergism, LLC, an Kelly Willenberg is President of Synergism, LLC, an Kelly Willenberg is President of Synergism, LLC, an independent consulting firm independent consulting firm independent consulting firm independent consulting firm

◦ kelly@synergismkelly@synergismkelly@synergismkelly@synergism----llc.comllc.comllc.comllc.com

◦ 864-473-7209

� Karen Mottola is a Clinical Research Compliance Officer Karen Mottola is a Clinical Research Compliance Officer Karen Mottola is a Clinical Research Compliance Officer Karen Mottola is a Clinical Research Compliance Officer at the University of Utahat the University of Utahat the University of Utahat the University of Utah

◦ karen.mottola@hsc.utah.edukaren.mottola@hsc.utah.edukaren.mottola@hsc.utah.edukaren.mottola@hsc.utah.edu

◦ 801-213-3603