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Electronic Transactions and

Code Sets Enforcement

CMS Office of HIPAA Standards

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Enforcement of Administrative Simplification Standards

CMS named to enforce HIPAA transactions and code setsOCR continues to enforce HIPAA privacyCMS creates Office of HIPAA Standards

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Office of HIPAA Standards

OutreachRegulations and PolicyEnforcement

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Enforcement Responsibilities

Establish enforcement process Develop regulations

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Enforcement Reality

CMPs may not be more than - - $100/violation

- $25,000/calendar year for violation of an identical requirement or prohibition

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Enforcement Authority

Two provisions of HIPAA government enforcement- § 1176: civil monetary penalties (CMPs)

- § 1177: criminal penalties

• HHS has authority to assess CMPs • DOJ has authority for criminal

penalties

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Enforcement Regulation

HHS lead on developing enforcement regulationSimplifies and standardizes the enforcement processProvides a predictable process

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Enforcement Regulation

Notice of what constitutes a violation and how penalties will be determinedHapless vs. WillfulRulemaking process allows for public input

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From Complaint To Compliant

Complaint drivenVoluntary complianceTechnical assistanceCorrective action planProgressive Steps

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Complaint Driven

Complaints - web submittal- download and mail Notification in writing

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Voluntary Compliance

Opportunity to demonstrate complianceGood faith efforts go a long way

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Technical Assistance

Focus on educating providers and covered entitiesRoundtables, informational papersASK HIPAA and HIPAA hotline

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Corrective Action Plan

Opportunity to submit corrective action planDemonstrate and document efforts to become compliantExercise reasonable diligence, make efforts to correct problem

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Progressive Steps

Compliance FIRST Corrective Action MIDDLETied for LAST: - CMPs - Exclusion from Medicare Access to care and patient safety

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What CMS WILL DO

Actively listenActively participate in your conferencesWe want voluntary compliance as much IF NOT MORE than you do

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Questions?