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Hot Spots in Compliance 2016
Patric Hooper
Katrina Pagonis
Hooper, Lundy & Bookman, PC
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Overview
Topics Covered
OIG Work Plan
Meaningful Use Audits
Site Neutrality: Bipartisan Budget Act Section 603 and Off-Campus HOPDs
False Claims Act Update
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2016 OIG Work Plan
Released November 2, 2015
Available at: http://oig.hhs.gov/reports-and-publications/archives/workplan/2016/oig-work-plan-2016.pdf
Hospitals Addressed pp. 5-11
Meaningful Use pp. 75-76
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2016 OIG Work Plan NEWFocus Areas
Few new areas of focus in 2016
Medical Device Credits for Replaced Medical Devices
Medicare Payments During MS-DRG Payment Window
CMS Validation of Hospital-Submitted Quality Reporting Data
Revised: Medicare Oversight of Provider-Based Status
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2016 Work Plan: Areas of Continued Focus
Comparison of provider-based and free-standing clinics
Hospitals’ use of outpatient and inpatient stays under Medicare’s two-midnight rule
Review of hospital wage index data used to calculate Medicare payments
Medicare costs associated with defective medical devices
Analysis of salaries included in hospital cost reports
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2016 Work Plan: Areas of Continued Focus
Nationwide review of cardiac catheterization and heart biopsies Review Medicare payments for right heart
catheterizations (RHC) and heart biopsies billed during the same operative session and determine if hospitals complied with Medicare billing requirements
Payments for patients diagnosed with kwashiorkor Evaluate whether the diagnosis is adequately
supported by medical record documentation (protein deficiency confusion)
Bone marrow or stem cell transplants
Indirect medical education payments
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2016 Work Plan: Areas of Continued Focus
Intensity-modulated radiation therapy (IMRT) Focus on services performed as part of developing
an IMRT plan that are required to be bundled but were billed separately
Hospital preparedness and response to high-risk infectious diseases Recent lessons from pandemic or highly contagious
diseases (e.g., Ebola)
Previous focus on natural disaster preparedness (Superstorm Sandy)
Meaningful Use Audits
OIG Work Plan
As of December 2015, $31.9 billion paid in Medicare and Medicaid EHR Incentive Payments
$12.5 billion to Eligible Professionals
$18.9 billion to Eligible Hospitals and CAHs
Surpasses CBO’s estimate ($30 billion)
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CMS Progressive Goals for Each Stage
HIT will likely be key to a data-driven reimbursement future
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Stage 1
Stage 2
Stage 3
Meaningful Use Timeline (after October 2015 Final Rule)
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“Certified” EHR Technology (CEHRT)
Must demonstrate Meaningful Use with EHR “certified” by designated certification agencies Commercially available software
Self-developed technology may be certified
Standards are set by the Office of the National Coordinator for Health IT (ONC) 2011 Edition
2014 Edition
2015 Edition
In 2016, must use 2014 edition, 2015 edition, or 2014/2015 combination CEHRT
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Single Set of Objectives and Measures
Objectives and Measures
All providers are required to attest to a single set of objectives and measures
EPs—ten objectives
EHs and CAHs—nine objectives
Replaces old core and menu structure
Transition for newer meaningful users:
2015—eight alternate measures/exclusions
2016—two alternate exclusions
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2015/2016 Measures for Eligible Hospitals
Protect Patient Health Information
Clinical Decision Support*
Computerized Provider Order Entry (CPOE)**
Electronic Prescribing (eRx)**
Health Information Exchange*
Patient-Specific Education*
Medication Reconciliation*
Patient Electronic Access*
Public Health Reporting*
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2016 Changes to Alternate Measures and Exclusions
Eliminates alternate measures available in 2015 and reduces alternate exclusions
Remaining alternate exclusions for providers scheduled to be in Stage 1 in 2016
CPOE measures 2 and 3 (lab and radiology orders)
eRx objective and measure (exclusion also available for providers scheduled to demonstrate Stage 2 that did not intend to select eRx objective)
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Reporting on Clinical Quality Measures (CQMs)
Beginning in 2014, all providers beyond their first year of demonstrating meaningful use (regardless of their stage) must report CQMs
EPs must report on nine CQMs across three domains
EHs and CAHs must report on 16 across three domains
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Reporting on CQMs:Eligible Hospital Options
Attest to CQMs through the Registration and Attestation System
eReport through Hospital Inpatient Quality Reporting (IQR)
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Payment Adjustments
Adjustments began October 1, 2014
Applies to providers eligible to participate in Medicare EHR Incentive Program
Payment adjustment is applicable to the percentage increase to the Inpatient Prospective Payment System (IPPS) payment rate for those eligible hospitals that are not meaningful EHR users
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Payment Adjustments
Adjustment starts at 25% of the annual increase to the IPPS
By 2017, adjustment will be 75% of the annual increase to the IPPS
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2015 2016 2017 2018 2019 2020+
% Decrease in Annual Increase to IPPS
25% 50% 75% 75% 75% 75%
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Payment Adjustments
Payment Adjustment
Year
Providers Demonstrating MU for First Time
Providers that Previously
Demonstrated MU
FY 2016 90-day period in FY 2014 or 2015 (ends by June 30, 2015)
90-day period in FY 2014
FY 2017 90-day period in FY/CY 2015 or CY 2016 (must attest by Oct. 1,
2016)
90-day period in FY2015 or CY 2015
FY 2018 90-day period in CY 2016 or 2017 (must attest by Oct. 1, 2017)
CY 2016
FY 2019 90-day period in CY 2017 CY 2017(Stage 3: 90-day period
in CY 2017)
FY 2020 90-day period in CY 2018 CY 201819
Hardship Exceptions
Hardship Applications for 2017
EPs: Due March 15, 2016
EHs and CAHs: April 1, 2016
New streamlined application
Bases for Hardship Exception:
Lack of control over the availability of CEHRT (EP only)
Lack of face-to-face patient interaction (EP only)
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Hardship Exceptions
Bases for Hardship Exception (cont.):
Insufficient internet connectivity
Extreme and uncontrollable Circumstances
Disaster
Practice or hospital closure
Severe financial distress (bankruptcy or debt restructuring)
EHR certification/vendor issues21
Hardship Exceptions
Must reapply every year (where application is required)
Maximum five years of hardship exceptions
CMS says hardship determinations are not appealable
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Hardship Exceptions: Tips
Prepare and submit early
On CMS-provided Hardship Application forms, ignore and do not check boxes that do not apply
E.g., “Unforeseen and/or Uncontrollable Circumstances”
Designated representative may submit hardship application on behalf of providers
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Automatic Hardship Exceptions
Automatic Hardship Exceptions:
New hospitals (10/1/2014 to 9/30/2016)
New EPs
Specialists (Anesthesiology, Diagnostic Radiology, Interventional Radiology, Nuclear Medicine, Pathology)
Hospital-based EPs are not subject to payment adjustment
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Compliance Considerations
Regulatory compliance is significant because meaningful use impacts reimbursement
Possible overpayments
Entirety of EHR incentive payment (failing to meet any MU measure)
Portion of EHR incentive payment (mistake in data used to calculate)
Payment adjustments owed25
Compliance Considerations
Potential strategies:
Designating resources for meaningful use questions (e.g., compliance, legal)
Developing policies and procedures regarding meaningful use and documentation retention
Conducting periodic, internal audits
Assuring compliance with other EHR incentive program requirements
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Document Retention
At least six years post attestation
Including the documentation that supports the values you entered in the Attestation Module for clinical quality measures
Documentation that supports payment calculations
CMS suggests that providers download and/or print a copy of the report used at the time of attestation for their records
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Examples of Additional Documentation
Drug-Drug/Drug-Allergy interaction checks Dated screenshots
Protect electronic health information Report documenting procedures performed and
results, dated prior to the end of the reporting period
Electronic exchange of health information Dated screenshots documenting test exchange Dated record of electronic transmission Communication from receiving provider
confirming successful exchange28
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Examples of Additional Documentation
CQMs Validate all CQM data submitted
Exclusions Report showing denominator of zero Other documentation substantiating exclusion
Other unique issues Permissible elections made by EP or eligible
hospital Documentation and analysis to support any
deviation from report (e.g., correcting for user error)
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Internal Audits
May be useful tool to uncover issues when they can still be remedied
Timing? Pre-attestation audits are more likely to allow for resolution of issues
Goals? Audit should not substitute for attestation
processes
Audit should be focused on spot-checking processes and providing recommendations for improvement
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Government Meaningful Use Audits
Government wants to ensure incentive payments are/were appropriate
Types of audits
Pre-payment (random and may target suspicious/anomalous data)
Post-payment
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Meaningful Use Audits (cont.)
Process Audit Letter via email requests documents
with two-week turnaround
Documents are provided A HIPAA-covered entity is allowed to
disclose PHI to a health oversight agency for activities authorized by law, such as audits But remember minimum necessary rule
Auditor reviews conduct based on documents or may require on-site reviews/questions
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Auditors
Medicare
CMS’ Audit Contractor: Figliozzi and Company (Accountants)
Audits all measures for one attestation
OIG Audits
Audits selected measures for three years
Medi-Cal
DHCS Audits
OIG Audits33
OIG Work Plan Relating to EHRs
Whether providers were entitled to Medicare/Medicaid EHR incentive payments
CMS’ oversight of Medicare/Medicaid EHR incentive payments
Protection of electronic health information, including through a security risk analysis of CEHRT
FDA oversight of hospitals’ networked medical devices that are integrated with EHR systems
The extent to which hospitals have EHR contingency plans, as required by the HIPAA Security Rule
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OIG Audit of Medi-Cal EHR Incentive Payment Calculations
Requested data re: inclusion/exclusion of the following data: Bad Debt and Courtesy Discounts Nursery Services Psychiatric Services Rehabilitation Services SNF Services Hospice Services NICU and Other ICU Services Labor and Delivery Services Unpaid Medicaid Bed Days
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Appeal Rights (CMS)
Types of appeals Failed MU Audit
Failed MU Reporting
MU Eligibility
Filing deadline: 30 days from adverse audit determination
letter (Failed MU Audit)
30 days from attestation deadline
Must file form and all supporting documentation
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The Next Phase: MIPS
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Merit-based Incentive Payment System (MIPS)
MIPS combines PQRS, Value Modifier, and Medicare EHR Incentive Program into a program based on: Quality Resource use Clinical practice improvement Meaningful use of certified EHR technology
Rulemaking expected this spring37
Site Neutrality and Off-Campus Outpatient Departments
Section 603 of the Bipartisan Budget Act of 2015, enacted November 2, 2015
Adopts site neutrality for certain off-campus HOPDs starting January 1, 2017
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Overview of Section 603
Beginning 1/1/2017: No OPPS reimbursement for items and services furnished “by an off-campus outpatient department of a provider” except if furnished by: An on-campus HOPD
An HOPD within 250 yards of a remote campus
A dedicated emergency department
A grandfathered HOPD
Payment may be available under other payment systems (e.g., ASC, PFS)
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On-Campus HOPDs
Defined in provider-based rules (42 CFR 413.65)
Campus is: Area “immediately adjacent” to provider’s
main buildings
Areas and structures “located within 250 yards” of the main buildings
Other areas per regional office determination
Note: on-campus locations are “on the hospital property” for EMTALA purposes
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250 Yards?
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C
D
A
E
B
Main Hospital
Remote Locations
Facility that furnishes inpatient hospital services under the name, ownership, and financial and administrative control of the main provider
Does not include a “satellite facility” (in another hospital’s building or on another hospital’s campus)
Regional office does not have discretion regarding 250-yard rule for remote locations
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Dedicated ED Exception
Section 603 excludes “items and services furnished by a dedicated emergency department (as defined in section 489.24(b) of title 42 of the Code of Federal Regulation)”
Exclusion is based on site of service, permitting OPPS reimbursement for non-emergency services furnished in an ED
Section 489.24 is CMS’ EMTALA regulation
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Off-Campus EDs and California Law Issues
California recognizes the following ED types: Basic emergency medical service, physician
on duty Comprehensive emergency medical service Standby emergency medical service, physician
on call
Standby ED must be located in a specifically designated area of the hospital There is a possible argument that a standby ED
may be off-campus in a separate physical plant under a consolidated license
CDPH has taken a more restrictive view
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Grandfathered HOPDs
Exception for “a department of a provider (as [defined in 413.65(b)]) that was billing under this subsection with respect to covered OPD services furnished prior to the date of enactment of this paragraph”
Key question: Was the HOPD billing for covered OPD services as of November 2, 2015?
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Existing HOPDs: Does Grandfathering Survive?
Relocation
Renovation and expansion
From on-campus to off-campus location?
From off-campus to off-campus location?
Acquisition by a new hospital
Break in operations
Non-compliance with provider-based rules
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Hypothetical Relocation of an Imaging Center
Current imaging center is off-campus
Lease is expiring in August 2016
Space is problematic (HVAC issues, no sprinkler system, etc.)
Hospital purchases new off-campus site in March 2015; begins construction
Will use substantially the same equipment/personnel in the new space
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Hypothetical Relocation of an Imaging Center
What if the new imaging center would add PET/CT services?
What if the services stay the same, but the new space is 50% larger?
What if the current HOPD was located on the main hospital campus?
What if the hospital opened an outpatient infusion department in the old imaging department space?
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Acquisition of a Hospital (and its HOPDs)
Do the HOPDs continue to be grandfathered post-acquisition? Exception for “a department of a provider (as
[defined in 413.65(b)]) that was billing under this subsection with respect to covered OPD services furnished prior to the date of enactment of this paragraph”
Is assumption of the provider number necessary to continue grandfathering? Sufficient?
If grandfathering can survive an acquisition, due diligence re: provider-based status will be key
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CMS Guidance?
CMS will not offer any guidance until the OPPS proposed rule (mid-June or July)
OPPS rule is typically finalized in November
In the interim, providers can educate CMS by submitting scenarios via e-mail
Note, 2016 is a “grace” period; site-neutral payment is not implemented until January 1, 2017
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Further Congressional Action
Letter from Reps. Upton (House Energy and Commerce Committee Chairman) and Pitts (Health Subcommittee Chairman)
Invites comments from stakeholders on site-neutral payment policies and proposals
Emphasis on budget neutrality
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False Claims Act (FCA) Update
The FCA continues to be the government’s weapon of choice to enforce its anti-fraud efforts in healthcare
The FCA is a civil remedy used to recover money falsely claimed by government contractors, including health care providers
It may be enforced by private parties (whistleblowers) through it qui tam provisions
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Updates
In FY 2015, DOJ recovered over $1.9 billion in settlements and judgments from civil false claims cases involving the health care industry
Recoveries are less than last year due to fewer pharmaceutical cases ($96 million)
Hospitals involved in $330 million in settlements and judgments ($216 million from cardiac device settlement with nearly 500 hospitals in a qui tam case)
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Updates
Qui Tam Suits 80 percent of FCA recoveries involved
qui tam suits
638 qui tam suits filed in FY 2015 (health care and non-health care)
Increasing emphasis on Stark/AKS, particularly in cases brought by the government
Ramp up of FCA suits against MA plans
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United Health Services v. U.S. ex rel. Escobar
FCA suit pending in the Supreme Court
Focuses on implied false certification theory
Timeline
Petition granted on Dec. 4, 2015
Oral arguments in late April
Decision expected by the end of June
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Escobar—Questions Presented
Whether the “implied certification” theory of legal falsity under the FCA is viable;
If so, whether the implied certification theory of liability requires that the statute, regulation, or contractual provision violated expressly state that it is a condition of payment
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Statistical Sampling and Extrapolation
United States ex rel. Martin v. Life Care Centers of America Inc. (E.D. Tenn., Sep. 2014)
Court found sampling and extrapolation permissible to establish FCA liability
Government sample of 400 admissions
Arguing extrapolation to 54,396 additional admissions
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“Yates” Memorandum: Individual Liability
September 9, 2015 memo on “Individual Accountability for Corporate Wrongdoing”
Enhances focus on litigating claims against individuals Cooperation credit only where corporation
discloses relevant facts about individual misconduct
Investigate individuals at every stage Corporate settlements will no longer typically
include a release from liability for the corporation’s officers, directors, and employees
Look beyond individual’s ability to pay
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Questions?
Thank you
Patric HooperFounding PartnerHooper, Lundy & Bookman, PC(310) [email protected]
Katrina A. PagonisSenior CounselHooper, Lundy & Bookman, PC(415) [email protected]
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