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Page 1: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

HIGHLIGHTS FROM EXL PHARMA’S 4TH CLINICAL BILLING & RESEARCH COMPLIANCE March 1-2, 2010

New Orleans, LA

Page 2: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

HOT TOPICS IN RESEARCH & HEALTHCARE COMPLIANCE

Page 3: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Healthcare Regulatory Environment

Page 4: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Research Misconduct: Scientific versus Regulatory Misconduct

Regulatory Misconduct Conduct inconsistent with the regulations and

standards that govern the process of research

Scientific Misconduct Fabrication, falsification, plagiarism or other

practices that seriously deviate from those that are commonly accepted within the scientific community for proposing , conducting or reporting research

Research Compliance Professionals Handbook

Page 5: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Scientific Misconduct

Means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting results Fabrication is making up data or results and recording or

reporting them. Falsification is manipulating research materials,

equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.

Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.

Research Misconduct does not include honest error or differences of opinion. 42CFR93.103

Page 6: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Non-Compliance and Misconduct

Non-Compliance / Regulatory Misconduct Failure to comply with laws, regulations,

protocols May be intentional or unintentional

Scientific Misconduct Fabrication Falsification Plagiarism

Non-Compliance / Regulatory Misconduct

Scientific Misconduct

Page 7: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Specific Legal Standards

Professional Malpractice

Fraud and Misrepresentation Fraud / False Statements

Mail Fraud Wire Fraud

Fraud, Waste and Abuse Anti-Kickback Law Anti-Self Referral Law False Claims Act - qui tam relators

Page 8: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Hot Topics in Research Compliance

Investigator Responsibilities

Privacy HIPAA / ARRA / HiTech GINA

Clinical Research Billing

Lagniappe

Page 9: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Protecting the Rights, Safety & Welfare of Study SubjectsFDA Guidance Published October 2009

Clarifies for investigators and sponsors FDA’s expectation regarding investigator responsibility regarding:

ensuring that the study is conducted in accordance with the agreements, investigational plans, protocols and applicable regulations

supervising the conduct of the investigations study staff delegated tasks

protecting the rights, safety and welfare of study subjects

controlling the test article – drugs, biological products, and devices

Page 10: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Protecting the Rights, Safety & Welfare of Study SubjectsFDA Guidance Published October 2009

Investigators commit themselves to conduct and supervise investigations and to protect the rights, safety and welfare of participants. The level of supervision should be appropriate to the staff,

nature of the trial and the subject population. This includes the following:

When tasks are delegated, the Investigator is responsible for ensuring that the individual to whom a task is delegated is qualified to perform the task.

The Investigator should ensure that there is adequate training for all staff participating in the conduct of the study.

The Investigator is accountable for regulatory violations resulting from failure to adequately supervise the conduct of a clinical study.

Page 11: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Protecting the Rights, Safety & Welfare of Study SubjectsFDA Guidance Published October 2009

Protecting the Rights, Safety and Welfare of Study Subjects includes the following: Providing reasonable medical care for study

subjects for medical problems arising during participation in the trial that are, or could be, related to study intervention.

Providing reasonable access to needed medical care, either by the investigator or by another identified, qualified individual.

Adhering to the protocol so the study subjects are not exposed to unreasonable risks.

Page 12: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Health Information Privacy Health Insurance Portability and

Accountability Act (HIPAA) American Recovery and Reinvestment

Act of 2009 (ARRA) Health Information Technology for Economic

and Clinical Health Act (HiTech)

Genetic Information Nondiscrimination Act (GINA)

Page 13: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Health Insurance Portability and Accountability Act (HIPAA)

Under HIPAA’s “Privacy Rule” a covered entity may not use or disclose an individual’s “protected health information” (PHI) unless the use or disclosure is authorized in writing by the individual (or their personal representative) or a specified regulatory exception applies: Privacy Board or IRB Waiver or alteration of authorization Preparatory to Research Information on Decedent Limited Data Sets De-identified Data

Minimum Necessary Standard Business Associate Agreements Fines / Penalties

Page 14: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

ARRA, HiTech & Privacy Changes to the HIPAA Privacy and

Security Rules

Mandatory reporting for “breaches” Applies directly to business associates Caps on payment for PHI in research New civil and criminal penalties

Page 15: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

HiTech - Mandatory Breach Notification

Any Covered Entity (or Business Associate) that “accesses, maintains, retains, modifies, destroys, or otherwise holds, uses or discloses” unsecured PHI must notify individuals whose unsecured PHI has been (or reasonably believed to have been) accessed, acquired, or disclosed as a result of a breach

Breach of Unsecured PHI = Notification to individuals

Secured PHI =

Encryption

Page 16: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

HiTech - Mandatory Breach Notification

Effective Now! (September 23, 2009) Exceptions Must notify each individual Method of Notice:

Each individual by first class mail (or email if individual agrees) Alternative method if insufficient contact information (if for more

than 10 individuals, then website posting or media notice) Notice to “prominent media outlets” if more than 500 residents of

the state or jurisdiction are affected Concurrent Notice to HHS is more than 500 residents are affected;

an annual report to HHS including every breach Timing of notice – without unreasonable delay / within 60 days Content of notice requirements

Page 17: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

HiTech – No sale of PHI Current Rule: CE may receive payment for a

disclosure of PHI where that disclosure is permitted by the regulations (such as for research)

HiTech Rule: prohibits indirect and direct remuneration for a disclosure without the individual’s authorization; authorization must explain whether PHI can be further exchanged for remuneration by the downstream entity receiving the PHI – with exceptions

HHS regulations required by 8/17/10; will apply to disclosures 6 months after regulations issued

Exceptions apply

Page 18: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

HiTech – No sale of PHI - Exceptions

For public health activities For research, where the price charged

reflects the costs of preparation and transmittal of the data

For treatment For the sale, merger or transfer of the covered

entity To a business associate to perform functions for

the covered entity To an individual who wants copies of his or her PHI That fall within any future regulatory exceptions

Page 19: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

HiTech Enforcement Clarifies / expands liability for criminal

violations Increases civil penalties Harmed individuals to receive percentage

of Civil Monetary Penalties State Attorneys General may bring civil

actions Continuation of the Office of Civil Rights

corrective action plans Audits

Page 20: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

HiTech EnforcementState Attorney General

State AG may bring civil action in federal court: To enjoin further violation To obtain damages on behalf of the victim

Statutory damages: Up to $100 times the number of violations Not to exceed $25,000 for identical violations in a

calendar year Defendant pays State’s attorney fees

Effective NOW!

Page 21: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

New Mandatory Civil Monetary Penalties (CMPs)Tier Violation Type CMP for Each

ViolationA If offender “did not know, and by exercising

reasonable diligence would not have known,” that he/she violated the law

$100 - $50,000

B If the violation was “due to reasonable cause and not willful neglect”

$1000 - $50,000

C If the violation was due to “willful neglect” but was corrected

$10,000 - $50,000*Penalty required*

D If the violation was due to “willful neglect” and was not corrected

$50,000*Penalty required*

Maximum CMPs for Identical Violations in a CY - $1,500,000

Page 22: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Genetic Info Nondiscrimination Act (GINA) New Federal law that generally prohibits health insurance

companies, group health plans, and most employers to discriminate against subjects based on genetic information.

This law generally protects research subjects as follows: Health insurance companies and group health plans may NOT:

request genetic information from research studies use genetic information from research studies when making

decisions regarding eligibility or premiums Employers with 15 or more employees may not use subjects’

genetic information obtained from research studies when making a decision to hire, promote, or fire individuals, or when setting the terms of employment

GINA does not extend to life insurance, disability insurance, or long term care insurance.

Informed Consent Implications http://www.hhs.gov/ohrp/humansubjects/guidance/gina.html

Page 23: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Medicare Billing and Clinical Research

Medicare’s Clinical Trial Policy Extended Medicare coverage to “routine

costs” of “qualifying clinical trials”, as well as “reasonable and necessary” items and services used to diagnose and treat complications from participating in clinical trials

All other Medicare rules apply

Device Trials – Requires Medicare contractor approval

Page 24: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Research News on the Horizon Clinical Research Billing

Therapeutic Intent Off-Label Consistency among protocol, trial agreement

and informed consent Medicare Secondary Payer Rule

PhRMA and AdvaMed Codes of Ethics Prohibits entertainment, recreational items or

branded promotional gifts Provides guidance for educational meetings Prohibits more “non-educational” freebies

Page 25: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Research News on the Horizon

Conflict of Interest & Physician Payment Sunshine Act of 2009 Manufacturers would be required to report annually certain

payments or other transfers to physicians or physician medical or group practices; and physician ownership interests in applicable manufacturing or group purchasing organizations

Payments include gifts, honoraria, speaking fees, consulting fees, travel, services, dividends, profit distributions, stock or stock option grants and ownership or investment interests

The aggregate amounts to initiate compliance would be $100 per calendar year.

Failure to report could results in civil monetary penalties

Page 26: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

TECHNOLOGY & COMPLIANCELessons Learned

Page 27: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Identifying a Solution Step 1 – Understand what

you have and where you are

Systems Business office Patient Records /

Registration Current Research Systems IT Capacity Who owns what and who

makes what decisions ?

Page 28: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Step 2 : What else to think about

People and Processes Does the current process work and is it

compliant ( how do you know that ? ) What’s done on the front end – what’s

done on the back end - who is responsible / held accountable ?

How are research patients identified in your system ?

Do the people involved even talk to each other ?

Do you have the requisite expertise to really understand what is involved ?

What do your clinicians ( investigators) understand?

Page 29: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Step 3: What solution is right for you ?

Knowing what you have to start with is really important Let me tell you a story !!!!

What kind of IT support will you have internally - what will you need from your vendor

How much modification are willing to / want to / should do ?

How change ready / averse is your organization ? What do you need to right now – what can you do

implement in a more phased approach

Page 30: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Budget + Contract + Protocol + Consent + MCA = Billing Compliance

Standardize contract language to extent possible Master Agreements Pass through costs

Standardize budget templates Standardize routine costs My experience ---- centralize key components /

decisions ( may not work for everyone) Budget detail takes time – but pays off in the

end - build budget / MCA to include investigational and conventional care items

Page 31: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Benefits of Web Based Systems

This is the easy part ---- Access to information Investigators / coordinators can view status Where is your information currently ? Data security / back up Easier to manage across multiple

organizations Build links to real time resource information

through links and “help”

Page 32: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Conclusions --

Education is a key component in assuring success

Create a taxonomy – How much integration can

you accomplish across all of your systems ?

In the end there is no Genie in the lamp -- our vision is to have all information related to research activity available with a single sign on

Page 33: Highlights from ExL Pharma's 4th Clinical Billing & Research Compliance

Still have any questions? For additional information on ExL Pharma’s Clinical Billing & Research Compliance Conferences, please visit

www.exlpharma.com


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