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2013 Health Care Regulatory Update January 8, 2013

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Page 1: 2013 Health Care Regulatory Update - Polsinellisftp.polsinelli.com/publications/events/healthcare/0113/resources/Evans.pdf2013 Health Care Regulatory Update January 8, 2013. Meaningful

2013 Health Care Regulatory UpdateJanuary 8, 2013

Page 2: 2013 Health Care Regulatory Update - Polsinellisftp.polsinelli.com/publications/events/healthcare/0113/resources/Evans.pdf2013 Health Care Regulatory Update January 8, 2013. Meaningful

Meaningful Use: Lessons Learned in Stage 1 and Looking Ahead to Stage 2

Jennifer Evans

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Agenda

• Brief Overview of Meaningful Use

• Lessons From Stage 1

• Looking Ahead to Stage 2

• Medicare Payment Adjustments/Reductions

• Congressional/OIG Oversight and Fraud and Abuse

• Other Practical Considerations

© 2012 Polsinelli Shughart PC3

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Meaningful Use: History Lesson

• The HITECH Act amended the Social Security Act by establishing Medicare and/or Medicaid incentive payments to promote adoption and meaningful use of interoperable health information technology

• A condition of meaningful use is the use of a “certified” EHR (EHR) system

• The Department of Health and Human Services (DHHS) was charged with establishing the certification criteria

• Office of the National Coordinator for Health Information Technology

• Medicare Penalties begin in 2015

© 2012 Polsinelli Shughart PC4

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History Lesson

Implementation in 3 stages• July 28, 2010: Final Rule Stage 1

– Described the criteria EPs and EHs must meet to receive incentive payments in Stage 1

• September 4, 2012: Proposed Rule – Stage 2– Proposes modifications to several Stage 1 criteria,

proposes additional criteria for Stage 2, and delays the implementation of Stage 2 criteria

– Delayed Stage 2 to 2014• Stage 3 begins in 2016• Generally meet each Stage for 2 years (2017)

© 2012 Polsinelli Shughart PC5

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3 Separate Incentive Programs

• Medicare Fee-For-Service

• Medicare Advantage

• Medicaid

• EHs/CAHs may participate in both the Medicare and Medicaid incentive programs

• EPs may participate in only one incentive program at a time. After a payment is made, an EP is permitted to switch between programs once before 2015

• Please note that the Medicare and Medicaid EHR incentive programs have different rules regarding the number of payment years available, the last year for which incentives may be received, and the lastpayment year for initiating the program

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Objectives and Measures

• Stage 1: Each EH and EP must demonstrate that they meet (or qualify for an exclusion to) all of the applicable core objectives and measures and 5 of the 10 objectives and measures from the “menu”set

– 14 core objectives for EHs/CAHs (Stage 1) + 5 menu

– 15 core objectives for EPs (Stage 1) + 5 menu

• Stage 2

– EHs/CAHs must meet (or qualify for an exclusion to) 16 core objectives and 3 of 6 “menu” objectives

– EPs must meet (or qualify for an exclusion to) 17 core objectives and 3 of 6 “menu” objectives

– If an exclusion for a “menu” objective applies, must choose another “menu” objective

© 2012 Polsinelli Shughart PC7

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Clinical Quality Measures

• Stage 1– EPs: 3 required plus 3 additional from a menu– EHs/CAHs: 15 required

• Stage 2– EPs: 9 required– EHs/CAHs: 6 required

• All can be calculated automatically by certified EHRs• In first year, may submit by attestation. Thereafter, CQM data must

be electronically submitted• Medicaid providers submit CQMs according to their state-based

submission requirements• Documentation must be maintained for 6 years

© 2012 Polsinelli Shughart PC8

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Medicare Incentive Amounts—EPs

© 2012 Polsinelli Shughart PC

Maximum Total Amount Of EHR Incentive Payments For A Medicare EP Who Does Not Predominantly Furnish Services In A HPSA

First CY in which the EP receives an incentive payment

Incentive Payment Year

2011 2012 2013 2014 2015-subsequent

years

2011 $18,000

2012 12,000 $18,000

2013 8,000 12,000 $15,000

2014 4,000 8,000 12,000 $ 12,000

2015 2,000 4,000 8,000 8,000 $0

2016 2,000 4,000 4,000 0

Total $44,000 $44,000 $39,000 $24,000 0

*10% adjustment for HPSAs9

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Medicaid Incentive Amounts—EPs

• Medicaid

– Up to 85% costs of adopting, implementing, or upgrading certified EHR

– $21,500 in Year 1

– $8,500 in subsequent years

– 6 years maximum

– Must begin in CY 2016

– $63,700 total available

– Medicaid OR Medicare

© 2012 Polsinelli Shughart PC10

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Incentive Amounts - EHs

© 2012 Polsinelli Shughart PC

Medicare incentive payments to eligible hospitals and CAHs are based on a number of factors, beginning with a $2 million base payment + “discharge related amount” x Medicare share percentage (which includes FFS and MA bed days), modified by a charity care factor and a transition share

Hospitals began receiving incentive payments in FY 2011 and may continue through FY 2015, but payments will decrease for hospitals that start receiving payments in 2014 and later

Medicaid incentive formula is similar. Payments over 3-6 year period

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Lessons from Stage 1

Practical Issues and Barriers

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Practical Lessons Learned from Stage 1

• EPs in Multiple Locations

– 50% encounter rule

– Calculating the objectives (e.g., patient volume)

– Obtaining data from all locations

• EPs Without Regular Patient Contact

– Calculating Measures

– Using data in the EHR from other providers

– Categorization of services for patients as “seen by the EP”

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Practical Lessons Learned from Stage 1

• Mid-Level Provider Involvement in Care

– Included as a patient encounter?

– Entry of orders/eRx by Mid-Levels

• Delegated Attestation

– Some Medicaid programs do not allow this

• Departments of EHs/CAHs

– Depends on whether units/departments are excluded from IPPS

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Looking Ahead to Stage 2

Additional RequirementsCommunicating with Your CEHRIT

Medicare Payment Adjustments/Reductions

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Stage 2: Changes and Criteria

• Starting in 2014, providers who have met Stage 1 criteria for 2 or 3 years must meet the Stage 2 criteria

• Nearly all of the Stage 1 criteria are retained and required in some form

• Combined multiple Stage 1 objectives into more unified Stage 2 objectives– E.g., combining as one objective, maintaining an up-to-date

problem list, active medication list, and allergy list• Increased threshold requirements – Exceptions Don’t Count

– EPs: 17 Core, 3/6 Menu Set– EHs: 16 Core 3/6 Menu Set– See Appendix for Detail

• Standardization of denominators• Use of Batch Reporting for Groups

© 2012 Polsinelli Shughart PC16

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Stage 2: Communicate with Your CEHRIT

• Patient Engagement– >5% of patients must send secure messages to their

EP– >5% of patients must access their health information

online• Electronic exchange of information use cases

– More than 10% of summary of care records for transitions of care and referrals must be electronically transmitted

– At least one summary of care document must besent electronically to a recipient with a differentEHR vendor or to CMS test EHR

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Stage 2: Electronic Submission of CQMs

• 2014: Medicare incentive program participants in second year and beyond of demonstrating meaningful use must electronically report their CQM data to CMS

• CMS has made attempts to align CQMs across multiple programs

– Potential to minimize multiple submissions

• EPs: PQRS EHR reporting option, PQRS GPRO options, Medicare SSP or Pioneer ACOs

• EHs/CAHs: eReporting pilot, beginning with the Hospital IQR Program

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Medicare Payment Adjustments

• 2015: Apply if not a meaningful EHR user

• A provider becomes a meaningful EHR user by successfully attesting to meaningful use under either the Medicare or Medicaid incentive program

– Must attest to meaningful use by meeting the meaningful use objectives through the use of CEHRT

– Receiving first year Medicaid incentive payments for Adopt/Implement/Upgrade ≠ becoming a meaningful EHR user

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EP Medicare Payment Adjustments

• To avoid payment adjustments EPs must demonstrate meaningful use in every year

– 2015: 1% reduction of Medicare reimbursement (2% if the EP is subject to the payment adjustment for eRx in 2014 under MIPAA)

– 2016: 2% reduction of Medicare reimbursement

– 2017: 3% reduction of Medicare reimbursement

– 2018 +: if less than 75% of EPs are meaningful users, decrease 1% of applicable reduction – up to 5% of Medicare reimbursement

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EP Medicare Adjustment Reporting Periods

• Payment adjustments are based on the prior years’reporting period

• For an EP who demonstrated meaningful use in 2011 or 2012

20182017201620152014*2013Based on Full Year Reporting Period

202020192018201720162015Payment Adjustment Year

*Special 3 month EHR reporting period for Stage 2 objectives

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EP Medicare Adjustment Reporting Periods

• For an EP who first demonstrates meaningful use in 2013

20182017201620152014*Based on Full Year Reporting Period

2013Based on 90 Day Reporting Period

202020192018201720162015Payment Adjustment Year

*Special 3 month EHR reporting period for Stage 2 objectives.

• If an EP first demonstrates meaningful use in 2014, in order to avoid the 2015 payment adjustment, the EP must attest no later than October 1, 2014, which means their 90 day reporting period must begin no later than July 1, 2014 22

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EH Medicare Payment Adjustments

• EHs who cannot demonstrate meaningful use

– FY 2015: ¼ reduction of market basket update

– FY 2016: ½ reduction of market basket update

– FY 2017 and beyond: ¾ reduction of market basket update

Example: If the increase to IPPS for 2015 was 2%, than a hospital subject to the payment adjustment would only receive a 1.5% increase.

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EH Medicare Adjustment Reporting Periods

• Payment adjustments are based on the prior years’reporting period. Reporting periods differ for EHs and CAHs

• For an EH who demonstrated meaningful use in FY 2011 or FY 2012

20182017201620152014*2013Based on Full Year Reporting Period

202020192018201720162015Payment Adjustment Year

*Special 3 month EHR reporting period for Stage 2 objectives

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EH Medicare Adjustment Reporting Periods

• For an EH who first demonstrates meaningful use in FY 2013

20182017201620152014*Based on Full Year Reporting Period

2013Based on 90 Day Reporting Period

202020192018201720162015Payment Adjustment Year

*Special 3 month EHR reporting period for Stage 2 objectives

• If an EH first demonstrates meaningful use in 2014, in order to avoid the 2015 payment adjustment, the EH must attest no later than July 1, 2014, which means their 90 day reporting period must begin no later than April 1, 2014

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CAH Medicare Payment Adjustments

• Absent a payment adjustment, reasonable cost reimbursement is 101%

• CAHs who cannot demonstrate meaningful use

– FY 2015: 100.66% reasonable cost reimbursement

– FY 2016: 100.33% reasonable cost reimbursement

– FY 2017 and beyond: 100% reasonable cost reimbursement

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CAH Medicare Adjustment Reporting Periods

• Payment adjustments are based on the prior years’reporting period

• For a CAH who demonstrated meaningful use prior to FY 2015

202020192018201720162015Based on Full Year Reporting Period

202020192018201720162015Payment Adjustment Year

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Page 28: 2013 Health Care Regulatory Update - Polsinellisftp.polsinelli.com/publications/events/healthcare/0113/resources/Evans.pdf2013 Health Care Regulatory Update January 8, 2013. Meaningful

CAH Medicare Adjustment Reporting Periods

• For a CAH who first demonstrates meaningful use in FY 2015

20202019201820172016Based on Full Year Reporting Period

2015Based on 90 Day Reporting Period

202020192018201720162015Payment Adjustment Year

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EP Hardship Exceptions

• Infrastructure: In an area without sufficient internet access or insurmountable infrastructure barriers

• New EPs: Newly practicing EPs (2 year exception)

• Unforeseen Circumstances: Natural disasters, etc.

• Special Practice Circumstances: Lack of face-to-face or telemedicine interaction with patients or lack of follow-up need with patients

– Primary specialties of anesthesiology, radiology, or pathology will receive a hardship exception

• Multiple Locations: Lack control over availability of CEHRT for more than 50% of patient encounters

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EH/CAH Hardship Exceptions

• Infrastructure: In an area without sufficient internet access or insurmountable infrastructure barriers

• New EHs/CAHs: New CCNs

– CAHs limited to 1 full year after acceptance of first Medicare patient

– EHs 1 full-year cost reporting period after acceptance of first Medicare patient

• Unforeseen Circumstances: Natural disasters, etc.

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Applying for Hardship Exceptions

• Must demonstrate to CMS that circumstances pose a significant barrier to achieving meaningful use

• Applications for exceptions must be submitted no later than April 1 for EHs, and July 1 for EPs, of the year beforethe payment adjustment year

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Congressional Oversight and Fraud and Abuse

• Office of National Coordinator

– Extra regulatory authority

• Consider the False Claims Act

• CMS Compliance Reviews

– Verification of attestation

– Recoupment of overpayments

• Providers should develop an audit strategy

• Retain supporting documentation – recommended period is 10 years from the date of registration

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Electronic Records = Fraud?

• September 24, 2012

• HHS Secretary Sebelius and Attorney General Holder’s letter to hospital associations

• “Troubling indications” of “gaming the system”– Cloning medical records– Upcoding intensity of care or severity of condition

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OIG Report on CMS Oversight

• November 29, 2012

• Used data from May – December 2011

– 26,653 professionals

– 668 hospitals

• CMS oversight “leave[s] the program vulnerable to paying incentives … that do not fully meet the meaningful use requirements”

• Identified deficiencies in prepayment safeguards and post-payment audits

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Other Practical Considerations

• Budget Considerations

• Physician Reassignment

• Contracting Needs: EHRs and HIEs

– Information Technology and Licensing

– Service Level Agreements

– Termination Provisions

– Physician Contracts and Attestations

– HIPAA is Important

© 2012 Polsinelli Shughart PC35

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References and Resources

• 42 C.F.R. Parts 412, 413, and 495• 75 Fed. Reg. 44314 (July 28, 2010)• 77 Fed. Reg. 53968 (Sept. 4, 2012)• CMS EHR Incentive Program Website:

https://www.cms.gov/EHRIncentivePrograms/01_Overview.asp#TopOfPage

• Attestation User Guide for EHs: https://www.cms.gov/EHRIncentivePrograms/Downloads/HospAttestationUserGuide.pdf

• Attestation User Guide for EPs: https://www.cms.gov/EHRIncentivePrograms/Downloads/EP_Attestation_User_Guide.pdf

• Meaningful Use FAQs: https://www.cms.gov/EHRIncentivePrograms/Downloads/FAQsRemediatedandRevised.pdf

© 2012 Polsinelli Shughart PC36

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Meaningful Use: Lessons Learned in Stage 1 and Looking Ahead to Stage 2

Appendix:

Stage 2

Objectives & Measures

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Objectives and Measures – Stage 2

© 2012 Polsinelli Shughart PC

EPs Core Set (17 objectives)1. Use computerized provider order entry (>60% for medication, 30%

for laboratory, and 30% for radiology)2. Generate and transmit permissible prescriptions electronically (>50%

Rx)3. Record demographics (>80%)4. Record and chart changes in vital signs (>80%)5. Record smoking status for patients 13 yo and older (>80%)6. Use clinical decision support to improve performance on

high-priority health conditions (5 clinical decision interventionsplus drug/drug and drug/allergy)

7. Incorporate clinical lab test results into certified EHR as structured data (>55%)

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Objectives and Measures – Stage 2

© 2012 Polsinelli Shughart PC

EPs Core Set (continued)

8. Generate lists of patients by specific conditions to use for QI,improvement, reduction of disparities, research or outreach (onereport)

9. Use EHR to identify patients who should receive reminders for preventive/follow-up care (>10% of patient with two or more office visits in the last 2 years)

10. Provide patients the ability to view online, download and transmit their information (online access to >50% with >5% actually accessing the information)

11. Provide clinical summaries for patients for each office visit (>50% within 24 hours)

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Objectives and Measures – Stage 2

© 2012 Polsinelli Shughart PC

EPs Core Set (continued)12. Use EHR to identify patient-specific education resources (>10%)13. Use secure electronic messaging to communicate with patients

(>5%)14. Perform medication reconciliation on a transfer (>50% of transitions

of care)15. Provide summary care record for each transition of care or referral

(>50% of transitions of care and referrals with 10% sent electronically and at least 1 sent to a recipient with a different EHR vendor or successfully testing with CMS test EHR)

16. Capability to submit information to immunization registry (successful ongoing submission)

17. Conduct or review security analysis and incorporate in risk management process

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Objectives and Measures – Stage 2

© 2012 Polsinelli Shughart PC

EPs Menu Set (3 of 6)

1. Imaging results and information accessible through certified EHR(>10%)

2. Record patient family health history (>20%)

3. Capability to submit syndromic surveillance data to PH (successful ongoing submission)

4. Capability to identify and report cancer cases to a state registry (successful ongoing submission)

5. Capability to identify and report specific cases to a specialized registry (successful ongoing submission)

6. Enter an electronic progress note (>30%)

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Objectives and Measures – Stage 2

© 2012 Polsinelli Shughart PC

EHs Core Set (16 objectives)

1. Use computerized provider order entry (>60% for medication, >30%for laboratory, >30% for radiology)

2. Record demographics (>80%)

3. Record and chart changes in vital signs (>80%)

4. Record smoking status for patients 13 yo and older (>80%)

5. Use clinical decision support to improve performance on high-priority health conditions (5 clinical decision interventions plus drug/drug and drug/allergy)

6. Incorporate clinical lab test results into certified EHR as structured data (>55%)

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Objectives and Measures – Stage 2

© 2012 Polsinelli Shughart PC

EHs Core Set (continued)

7. Generate lists of patients by specific conditions (one report)

8. Automatically track medications from order to administration (>10%)

9. Provide patients the ability to view online, download and transmit their information about an admission (online access to >50% with>5% actually accessing the information)

10. Use EHR to identify patient-specific education resources (>10%)

11. Performs medication reconciliation on a transfer (>50%)

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Objectives and Measures – Stage 2

© 2012 Polsinelli Shughart PC

EHs Core Set (continued)

12. Provide summary care record for each transition of care or referral (>50% of transitions of care and referrals with 10% sent electronically and at least 1 sent to a recipient with a different EHR vendor or successfully testing with CMS test EHR)

13. Capability to submit information to immunization registry (successful ongoing submission)

14. Capability to submit electronic reportable lab results to PH (successful ongoing submission)

15. Capability to submit electronic syndromic surveillance data to PH (successful ongoing submission)

16. Conduct or review security analysis and incorporate in risk management process

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Objectives and Measures – Stage 2

© 2012 Polsinelli Shughart PC

EHs Menu Set (3 of 6)

1. Enter an electronic progress note (>30%)

2. Record whether a patient 65 yo or older has an advance directive(>50%)

3. Imaging results and information accessible through certified EHR(>10%)

4. Record patient family health history (>20%)

5. Generate and transmit permissible discharge Rx electronically (>10%)

6. Provide structured electronic lab results to EPs (>20%)

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2013 Health Care Regulatory Update

PS.3210451v1

Polsinelli Shughart PCwww.polsinelli.com

303.572.9300

January 8, 2013