HIT RECs: Contracting Issues

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HITECH Act additionally expresses that prerequisites ought to be consolidated into the business partner understandings. New State Attorney General Rights of Action ...

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HIT RECs: Contracting Issues Constance A. Wilkinson May 6, 2010 AHQA Annual Meeting

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Agenda Provider Contracts 2010 HIPAA and HITECH Payments HIT REC - QIO Contracts Conflict of Interest

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Factors Resulting in Increased Scrutiny of Holders of PHI Breach Notification Requirements of ARRA (HITECH Act) Distinct from the Act's endeavor to support reception of EHRs by impetus installments for "significant utilize" Direct use of security control to BAs HITECH Act likewise expresses that prerequisites ought to be fused into the business relate assentions New State Attorney General Rights of Action Government Audits

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Business Associates Now Directly Regulated Extension of Security Provisions to Business Associates Direct introduction to HIPAA common and criminal punishments Penalties can be as high as $50,000 per occurrence and $1,500,000 in the total "Resolute disregard" standard now included State Attorney General implementation HHS Secretary, with proposals from the GAO, must create instrument for hurt people to partake in the punishments (February 17, 2012)

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Terms of BA Agreement What should be incorporated? Rupture reporting Security Rule consistence Mutual end Access to records in EHRs Other incorporations Minimum important to reflect new standard Marketing Responsibility for tending to budgetary effect of breaks

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Breach Reporting in case of a "rupture" of "unsecured" PHI, a Covered Entity must tell every person whose unsecured PHI has been, or is sensibly accepted to have been, broke. Special cases where coincidental exposure to or by workforce, BA or sorted out human services course of action member The danger of damage standard requires that the influenced element attempt some type of hazard evaluation in case of a rupture to decide in compliance with common decency whether it is important to tell the person of the break. Does the break "represent a huge danger of money related reputational, or other damage to the person"? 2007 OMB Memorandum (M-07-16) gives cases of variables to consider

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Notice Requirements Notice must be made to the influenced people "immediately and for no situation later than 60 date-book days after disclosure of a break." For any rupture including at least 500 individuals, notice through the media and to the Secretary must be made If the break happens at or through a Business Associate, the Business Associate must advise the Covered Entity of the break inside 60 days of finding the rupture so that the Covered Entity can agree to its rupture reporting commitments.

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BA Agreement Considerations Should the BA make the evaluation of whether it was a break? Obligation rests with BA if BA makes wrong appraisal Notification timing Less than 60 days Will Covered Entity need to do its own evaluation? Who sends the notice?

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Security Rule Requirements Explicit consent to meet Security Rule Requirements Annual suitable specialized protections overhauls from HHS Should BA consent to obscure prerequisites? By what method will BA know about redesigns?

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Mutual Termination Should be non-dubious When/in what manner can Covered Entity rupture BA assention? Common end may goad BAs to request more duties from Covered Entity Notice and overhauled sees Restrictions by people

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Access and Accounting Different get to rights to records in EHR Right to bookkeeping of treatment, installment, and human services operations revelations from EHR Only need to accommodate three years before demand When will BA have EHR?

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Minimum Necessary Tightening meaning of "least vital" Implication for get to controls under Security Rule Secretary to issue direction on least important standard by August 17, 2010 BA consent to conform to concealed direction?

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Sample Language In agreement with Section 13405 of ARRA, the utilizations, exposures, or solicitations for the PHI portrayed in this might be, to the degree practicable, constrained to a Limited Data Set or the base fundamental (as might be depicted by the Secretary in direction on these terms) to finish the planned motivation behind such utilize, divulgence, or demand.

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Limitations on Marketing Necessary to incorporate? Promoting ought to be outside extent of what BA is doing Explicit dialect puts BA on notice and clarifies the comprehension between the gatherings

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Financial Responsibility for Breach BA monetarily in charge of any notices that must happen as an aftereffect of BA break Insurance? Constraint on measure of presentation? Repayment

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Resources Sample Business Associate Contract Provisions (pre-ARRA) http://www.hhs.gov/ocr/protection/hipaa/understanding/coveredentities/contractprov.html EBG Client Alert entitled, " Covered Entity Compliance with HITECH Act Amendments to HIPAA: An Overview of Requirements, Deadlines and Enforcement Environment", by Alicia H. Sable and H. Ditty Saul (February 2010). www.ebglaw.com/showClientAlert.aspx?Show=12454

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Program Funding Core Support $500,000-$750,000, quarterly Direct Assistance Support Quarterly premise Based on number of suppliers that accomplished points of reference in earlier quarter Milestone 1 – Contract with REC Milestone 2 – Go Live on EHR Milestone 3 – Certified for Meaningful Use

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Cost Sharing Requirements Years 1-2: $9 Federal/$1 REC Years 3-4: $1 Federal/$9 REC Potential Revenue Sources Provider charge Assignment of Medicaid EHR installments Contributions in trade or out kind Verifiable (documentation) Not paid under another honor Necessary and sensible for program destinations Unrecovered roundabout expenses, with Government endorsement, for state office

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Cost Sharing Requirements The coordinating prerequisites must be met before the end of the 2-year concede To the degree charges/reserves surpass the coordinating prerequisites, the abundance gets to be Program Income Program Income must be utilized to promote the reasons for the Program Income might be held and connected to future allow periods (commonly a 3-year remnant is allowed)

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Structure of Provider Fee Flat expense (upon start or course of events) Structured charge Based upon time allotment endless supply of Milestones heaps of Meaningful Use Incentives (rebates or discounts) endless supply of Milestones inside a predefined time period or improved (punishment) installments for deferrals/disappointments For bookkeeping purposes, might be desirable over structure as base installment/unexpected installment to encourage reporting of match/wage

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Structure of Provider Fee Provider installments in light of task of EHR impetus installments may likewise be founded on organized approach Structure might be founded on technique of evasion of irreconcilable situation suggestions under QIO contract Payments in overabundance of match prerequisite for initial two years, and coming about program wage, may alleviate impact in later years

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Conflict of Interest ONC FOA Terms "Local Centers will abstain from going into business connections making a genuine or evident irreconcilable circumstance with the [REC's] commitment to act exclusively to the greatest advantage of progressing significant utilization of confirmed wellbeing IT by the suppliers it serves." COI Certification "There are no potential, genuine or saw irreconcilable situations … between our association and the HIT merchant… ."

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Conflict of Interest SDPS Memo #10-014-CO, dated January 14, 2010 Clarification Letter Regarding QIO Organizational Conflict of Interest Issues Resulting From Award of Regional Center Cooperative Agreement by the Office of the National Coordinator CMS underpins the capacity of QIOs to perform work under the REC contracts the length of a few shields are set up to stay away from clashes Identified two potential clashes between HIT REC and QIO contracts

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Conflict of Interest Relationship with EHR Vendors "negotiating contracts with sellers or reseller" and helping "providers in considering sellers responsible for holding fast to administration level understandings" CMS has taken the position that a cozy relationship will exist amongst suppliers and substances selecting and consulting with sellers for their sake under the Extension Program contracts If the QIO is the sole awardee or lead, the work must be performed by a disconnected/unaffiliated subcontractor If the QIO is a colleague, the work must be performed by another irrelevant/unaffiliated individual from the gathering

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Conflict of Interest Provider Fee Payment to QIO "clear plausibility for the cost to a substantial supplier for these Regional Center administrations to surpass the five percent safe harbor under segment H.11 of the ninth SOW" 9 th SOW, Section H.11, Conflict of Interest Prohibits QIO from having monetary connections, particularly remuneration game plans, with suppliers it might work for under private contracts Includes parent organizations, auxiliaries, members, subcontractors, or current customers Includes "safe harbor" – the purported "5/20 run" Excludes supplier gets that don't surpass 5% of the aggregate cost of the QIO center contract independently or 20% in the total Should installments to a QIO for business related to an elected give/elected object be viewed as a "budgetary relationship" inside this denial?

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Conflict of Interest When a specific supplier's installments to the QIO (as a REC or an EA) surpass the 5% safe harbor (or those installments altogether surpass 20%), a contention exists Referral of any dissensions in regards to that supplier to another QIO would be required QIOs ought to create and present an alleviation technique Refer protests in regards to that supplier/suppliers to another QIO that does not have a REC contract/subcontract and is not related or partnered with the QIO

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Conflict of Interest If in uncertainty, r