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

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Highlights from ExL Pharmas 4th Clinical Billing & Research Compliance March 1-2, 2010New Orleans, LA


Research Misconduct: Scientific versus Regulatory MisconductRegulatory MisconductConduct inconsistent with the regulations and standards that govern the process of researchScientific MisconductFabrication, 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 HandbookScientific Misconduct Means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting resultsFabrication 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 persons ideas, processes, results, or words without giving appropriate credit.Research Misconduct does not include honest error or differences of opinion.42CFR93.103Non-Compliance and MisconductNon-Compliance / Regulatory MisconductFailure to comply with laws, regulations, protocols May be intentional or unintentionalScientific Misconduct FabricationFalsificationPlagiarism

Non-Compliance / Regulatory MisconductScientific MisconductSpecific Legal StandardsProfessional Malpractice

Fraud and MisrepresentationFraud / False Statements Mail FraudWire FraudFraud, Waste and AbuseAnti-Kickback Law Anti-Self Referral LawFalse Claims Act - qui tam relators

Hot Topics in Research ComplianceInvestigator Responsibilities

PrivacyHIPAA / ARRA / HiTechGINA

Clinical Research Billing


Protecting the Rights, Safety & Welfare of Study SubjectsFDA Guidance Published October 2009Clarifies for investigators and sponsors FDAs expectation regarding investigator responsibility regarding:ensuring that the study is conducted in accordance with the agreements, investigational plans, protocols and applicable regulationssupervising the conduct of the investigations study staff delegated tasksprotecting the rights, safety and welfare of study subjectscontrolling the test article drugs, biological products, and devicesProtecting the Rights, Safety & Welfare of Study SubjectsFDA Guidance Published October 2009Investigators 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.Protecting the Rights, Safety & Welfare of Study SubjectsFDA Guidance Published October 2009Protecting 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. Health Information PrivacyHealth 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)Health Insurance Portability and Accountability Act (HIPAA)Under HIPAAs Privacy Rule a covered entity may not use or disclose an individuals 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 authorizationPreparatory to ResearchInformation on DecedentLimited Data SetsDe-identified Data Minimum Necessary StandardBusiness Associate AgreementsFines / PenaltiesARRA, HiTech & PrivacyChanges to the HIPAA Privacy and Security Rules

Mandatory reporting for breaches Applies directly to business associatesCaps on payment for PHI in researchNew civil and criminal penaltiesHiTech - Mandatory Breach NotificationAny 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 = EncryptionHiTech - Mandatory Breach Notification Effective Now! (September 23, 2009)ExceptionsMust notify each individualMethod 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 affectedConcurrent Notice to HHS is more than 500 residents are affected; an annual report to HHS including every breachTiming of notice without unreasonable delay / within 60 daysContent of notice requirementsHiTech No sale of PHICurrent 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 individuals authorization; authorization must explain whether PHI can be further exchanged for remuneration by the downstream entity receiving the PHI with exceptionsHHS regulations required by 8/17/10; will apply to disclosures 6 months after regulations issuedExceptions applyHiTech No sale of PHI - ExceptionsFor public health activitiesFor research, where the price charged reflects the costs of preparation and transmittal of the dataFor treatmentFor the sale, merger or transfer of the covered entity To a business associate to perform functions for the covered entityTo an individual who wants copies of his or her PHIThat fall within any future regulatory exceptionsHiTech EnforcementClarifies / expands liability for criminal violationsIncreases civil penaltiesHarmed individuals to receive percentage of Civil Monetary PenaltiesState Attorneys General may bring civil actionsContinuation of the Office of Civil Rights corrective action plansAuditsHiTech EnforcementState Attorney GeneralState AG may bring civil action in federal court:To enjoin further violationTo obtain damages on behalf of the victim

Statutory damages:Up to $100 times the number of violationsNot to exceed $25,000 for identical violations in a calendar yearDefendant pays States attorney fees

Effective NOW!New Mandatory Civil Monetary Penalties (CMPs)TierViolation TypeCMP for Each ViolationAIf offender did not know, and by exercising reasonable diligence would not have known, that he/she violated the law$100 - $50,000BIf the violation was due to reasonable cause and not willful neglect$1000 - $50,000CIf the violation was due to willful neglect but was corrected$10,000 - $50,000*Penalty required*DIf the violation was due to willful neglect and was not corrected$50,000*Penalty required*Maximum CMPs for Identical Violations in a CY - $1,500,000Genetic 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 premiumsEmployers 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 Implicationshttp://www.hhs.gov/ohrp/humansubjects/guidance/gina.htmlMedicare Billing and Clinical ResearchMedicares Clinical Trial PolicyExtended 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 approvalResearch News on the HorizonClinical Research BillingTherapeutic IntentOff-Label Consistency among protocol, trial agreement and informed consent Medicare Secondary Payer RulePhRMA and AdvaMed Codes of EthicsProhibits entertainment, recreational items or branded promotional giftsProvides guidance for educational meetingsProhibits more non-educational freebiesResearch News on the HorizonConflict of Interest & Physician Payment Sunshine Act of 2009Manufacturers 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 organizationsPayments include gifts, honoraria, speaking fees, consul

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