National Regulatory Update

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National Regulatory Update

• 2009 Is Not Business As Usual
• Mary K. Ousley
• March 23, 2009

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HHS Strategic Plan 2007-2012

Improve the safety, quality, affordability and
accessibility of health care, including
behavioral health care and long-term care.
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Central VisionLong-Term Care

• Person-Centered
• Organized Based on Needs not Setting
• Provide Coordinated High Quality
• Optimize Choice Independence
• Served by an Adequate Workforce
• Be Transparent/Personal Responsibility
• Be Financially Sustainable
• Utilize Health Information Technology
• to Improve Access and Quality of Care.

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Todays Discussion

• Valued-Based Purchasing (P4P)
• 5-Star
• Online Rating System for Nursing Homes --
  'Zagat-izing' Long-Term Care?
• Quality Indicator Survey
• Traditional Survey System
• AHCA Legislative Proposal
• 2009 Legislative Issues Impacting LTC

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Goals For Value-Based Purchasing

• Financial ViabilityMedicare protected for
  beneficiaries and taxpayers.
• Payment Incentivespayments are linked to the
  value (quality and efficiency).
• Joint Accountability physicians and providers
  have joint clinical and financial accountability.
  
• Effectivenesscare is evidence-based and is
  outcomes-driven.

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Goals For Value-Based Purchasing

• Ensuring Access provides equal access to high
  quality, affordable care.
• Safety and Transparency provides information
  on the quality, cost, and safety of their
  healthcare.
• Smooth Transitions supports well coordinated
  care across different providers and settings.
• Electronic Health Recordsuse of information
  technology to give providers the ability to
  deliver high quality, efficient, well coordinated
  care.

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Approach

• Conducted in Cooperation with State Medicaid
  Agency
• November 14, 2008 CMS Solicited States to
  Participate.
• Mid-February to Identify States
• States Assist
• Recruitment/Selection of Facilities (50 per
  state)
• Data Collection
• SNFs apply and provide baseline measures--May
  2009
• SNFs assigned to experimental control
  groups--June 2009
• Experimental eligible for incentive
  paymentcontrol group submit information
• Demonstration begins July 1, 2009

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NHVBP

• One of several CMS P4P initiatives and is
  consistent with Institute of Medicine (IOM)
  recommendation to align payment incentives with
  quality improvement.
• Current payment systems do not reward or promote
  quality and may at times reward poor performance.
• Incentive payments can encourage providers to
  improve the quality of services they provide.

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Performance Measures

• Core set of performance measures used in the
  first year of the demonstration additional
  measures may be added for the second year.
• Performance measure categories
• Staffing (levels and stability) 30 points
• Potentially avoidable hospitalizations 30 points
• Outcomes from State survey inspections 20 points
• Quality measures (derived from the MDS) 20
  points

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Staffing Performance Measures

• Staffing measures
• Registered nurse/ Director of Nursing PRD
• Total licensed nursing hours PRD
• Certified Nurse Aide hours PRD and
• Nursing staff turnover rate
• Agency staff count 80 in staffing level
  measures.
• Case mix adjustment based on Resource Utilization
  Groupings (RUGS)

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Avoidable Hospitalizations

• Defined as hospitalizations with any of the
  following diagnoses
• Heart Failure Respiratory Infection Electrolyte
  Imbalance Sepsis Urinary Tract Infection
  Anemia (long-stay)
• Hospitalizations that stem from these medical
  conditions thought to be largely avoidable and/or
  manageable if the conditions are treated in a
  timely manner.
• Transfers directly from the SNF to the hospital
  and hospital admissions within three days after
  NH discharge.

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Clinical Outcomes Domain (MDS)

• Long-Stay Residents
• Percent whose need for help with ADLS has
  increased
• Percent whose ability to move in and about their
  room got worse
• Percent high-risk who have pressure sores
• Percent who have had a catheter left in their
  bladder
• Percent physically restrained

• Short-stay residents
• Percent with improving level of ADL functioning
• Percent who improve status on mid-level ADL
  functioning
• Percent of residents experiencing failure to
  improve bladder incontinence

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Survey Deficiencies Domain

• Screening measure---a serious deficiency (SQC) or
  enforcement action
• Points assigned based on scope and severity of
  health all deficiencies and number of revisits.
• Demonstration states should be subject to same
  survey system (QIS)

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Other Potential Performance Measures

• Performance measures that may be included
  beginning in the second year.
• Resident experience with care surveys
• Use of survey
• Resident satisfaction (based on a standard survey
  such as Nursing Home CAHPS)
• Staff immunization rate
• CMS will continue conducting research on these
  and other measures.

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Data Collection

• MDS-Based Quality Measures
• Survey Cycle---OSCAR
• HospitalizationsMedicare Claims
• Staffing---Payroll, Invoices, Case-Mix Adjusted
• Case mix model to be developed, based on case mix
  weights from the CMS time (STRIVE) measurement
  study that will be used to update the Medicare
  prospective payment system.

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Process

• Award Points for each Domain
• Summed to Produce Quality Score
• Provide Incentive Payment

• Exceptionally High Quality
• Show Significant Improvement

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Incentive Payments

• Budget Neutral
• Efficiency Factor --Savings from decrease in
  hospitalizations
• Reduction in Medicare Part A stays in nursing
  facilities
• Savings will create pool to make incentive
  payments
• Pool will be established each year and
  participants will be made aware

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Evaluation Analyzing Impact on Nursing Homes

• Quantitative Assessment
• Performance Outcomes
• Financial Outcomes
• Qualitative Assessment
• Management Operations
• Care Delivery
• Culture
• Assess impact of Medicare Medicare expenditures
• Assess feasibility of broader implementation.

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5-Star Nursing Home Rating System
P4P demonstration aligns with the design of the
five-star rating system.
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Three Rating Dimensions
Survey results
Quality Measures
Staffing
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Survey Scoring

• Each Deficiency Scored by Scope Severity
• More Points for Higher Scope, Higher Severity
• Weighted Scores Summed Similar to SFF Algorithm
  for
• 3 Most Recent Standard Surveys
• 3 Years of Substantiated Complaints
• Added Points for (a) substandard quality, (b)
  revisits needed beyond first revisit
• Most Recent Surveys Weighted More (1/2 1/3
  1/6)
• Survey Results State by State (i.e. Control for
  State Variation)
• Top 10 5-star middle 70 2,3,or 4 stars with
  equal number (23.33) Bottom 20 1 star.

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Quality Measure Ratings

• Long-Stay prevalence
• measures
• ADL Change
• Mobility Change
• High-Risk PU
• Long-Term Cath
• Physical Restraints
• UTIs
• Pain

• Short Stay Prevalence Measures
• Delirium
• Pain
• Pressure Ulcers

ADL Mobility .40 of total QM Score ADL
Mobility are state adjusted All other QMs are set
on a National distribution
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Staffing Domain

• Data from CMS Form 671 (future payroll)
• RN hours include RN, RN DON, nurses with
  administration duties.
• Total hours RN, LPN/LVN, CNA (includes CNA
  in-training and medication aides contract staff)

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Staffing Domain Case-Mix Adjusted

• Based on RUG III (53 group) system
• CMS 2001 Staff Time Measurement Study
• Calculation performed for each staff type
• Adjusted hours Hours reported/Hours expected
  Hours national average.
• ABT Study Optimal Hours PRD
• Total nursing hours (4.08)
• RN hours (.55)

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Calculating the Overall Rating
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Example
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Policy Issues--AHCA

• The Five-Star System is based on an inaccurate,
  inconsistent and arbitrary survey and
  certification system.
• The Five-Star System uses a staffing ratio that
  was rejected by CMS.
• CMS 671 does not reflect 2009 staffing profiles.
• QM/QIs are not definitive measures of quality of
  care, but are "pointers" that indicate potential
  problem areas that need further review and
  investigationshould not be used to rank
  facilities
• Lack of Correlation among QMs, Survey
  Deficiencies and Staffing Levels

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The ASK Five-Star Improvement

• January 22, 2009 Meeting with CMS
• Eliminate bell curve for ranking of facilities
• Change staffing metric, use expected staffing as
  the 5 star metricnot a study that was never
  funded nor recommended by CMS
• Update CMS 671 to better reflect current staffing
  realities (e.g., include therapy staff reflect
  universal worker, etc.)

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The ASK Five-Star Improvement

• Stars should inform each componentdue to lack of
  correlationeliminate overall star rating.
• Improve acuity adjustment for Quality Measures
• Ensure data use by CMS is accurate and current.
• Add a 4th cohort of patient/resident
  satisfaction.

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Survey CertificationSurvey SystemPerfect Storm

• GAO Reports 2000-2007
• Inconsistency in State Surveys
• Understatement of Serious Quality Problems
• Nursing Facilities continue to cycled in and out
  of compliance
• Immediate sanctions were not always cited,
• CMPs imposed at lower end of range
• OIG Study Complaint Investigations July 2006
• Failure to investigate within required
  timeframes.
• Complainants lacked meaningful information.
• CMS oversight is limited.
• CMS Interpretative Guidelines New
  Investigative Protocols
• 2004-2009

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Survey Certification

• Working with CMS to deal with issues and outlier
  states/regions
• CMS 2008 TransmittalInterpretive Guidelines
• Clarify MDS only Required Assessment
• Data Outlier States/Regions
• Working closely with CMS and Contractor on the
  evaluation of Quality Indicator Survey Process.

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QIS--Background

• A revised survey process
• Contract awarded in 2005 with University of
  Colorado to conduct initial demonstration.
• Contract expanded for implementation phase.
• Training
• Monitoring of Implementation

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Stages of the Quality Indicator Survey

• Stage I Preliminarily investigate all
  regulatory areas and determine care areas for
  in-depth Stage II review
• Stage II Determine if deficient practice, and
  document deficiencies including F tags, scope and
  severity

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Quality Indicator Survey

• Connecticut
• Kansas
• Ohio
• Louisiana
• Florida
• Maryland

• Minnesota
• North Carolina
• West Virginia
• New Mexico
• Washington

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QIS ImplementationStatus (February 2009)

• Surveys of Record 1,535
• Registered QIS Surveyors 338
• State Certified Trainers 40
• Trained CMS Regional Office Surveyors 12
  - 5 Regions

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Citations

• 40 of facilities had fewer or the same number of
  citations
• Zero deficiencies still occur
• 2 more citations on average
• Increases in specific regulatory areas
• Citations well documented, less frequently
  challenged and overturned in IDR
• Certain district offices with low citation rates
  increased more than district offices with high
  rates

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Quality Indicator Survey

• Next Steps
• Selecting States Based on readiness to conduct
  QIS (e.g. hardware)
• Determine Priority Order for Remaining States to
  implement QIS
• AHCA Regulatory CommitteeEvaluating
  Implementation

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AHCA Survey Legislative Proposal

• Modification to Social Security Act 2009
• (A)(i) Annual SurveysAdd The secretary shall
  review each States or other contractors, as
  chosen by the Secretary procedures for
  scheduling
• (A)(ii) Add A standard survey for a facility in
  the Top Tier shall consist of a quarterly
  off-site review of quality indicators as
  identified by the Secretary and a half day
  on-site review of quality of life and safety
  issues. These facilities will have a full
  standard survey once every three years.

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AHCA Survey Legislative Proposal

• Top Tier full survey conducted at statewide
  intervals not exceed 39 months
• Quarterly offsite quality indicator (improved
  QMs)
• Secretary reports to congress annually on goals
  provides data that reflects consistency of the
  survey process and status of appeals.
• Mandates action to assure consistent application
  within states and across states and timely
  appeals.

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AHCA Survey Legislative Proposal

• Notice to facilitya written report of survey
  must be given to the facility within 15
  daysReport of Survey includes all of the
  positive aspects of care and facility life as
  well as the aspects of care that are performed
  less well.
• CMPs shall be used for development of acuity
  adjusters that will provide more accurate
  information to the public, residents, and
  facilities about the quality of care.

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Status of Proposal

• Legislative Language Developed Approved by
  Board of Governors
• Discussion with Grassley Kohl
• Looking for Early VehicleFirst 100 Days
• Discussion with Staff Energy Commerce

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2009 SNF AL Legislative

• New Leadership CMSDon Berwick (maybe)
• Healthcare Reform vs. Entitlement Reform
• BudgetBundling, 30 day or Episode of Care
• Likely Legislation
• Nursing Home Transparency Improvement Act
  Grassley Kohl
• Arbitration Legislation Expected
• False Claims Act legislation expectedwould
  expand whistleblower protections
• Employee Free Choice Act (card check)
• Medicare Part D Co-Pay fix

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State Regulatory Trends AL

• State regulation of assisted living continues to
  evolve.
• Changes to accommodate more intense resident
  health and chronic care needs.
• Higher standards for Alzheimers/dementia care.
• Multi-level licensure systems.
• Fire safety, disease control, emergency
  preparedness incident reporting.
• Disclosure requirements.
• Staff training and
• resident rights.

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2009 NCAL Regulatory Review

• Annual report summarizing state regulations,
  published by NCAL in March (available free at
  www.ncal.org). In 2008
• At least 18 states made regulatory changes
  impacting assisted living/residential care
  communities
• Six of these states made major modifications to
  their regulations.
• At least 10 states are working on significant
  changes in 2009.
• In 2008, MD TN overhauled their regulations.
  NY promulgated regulations establishing AL
  licensure under a 2004 statute NH formally
  adopted rules governing one of two levels of
  licensure.
• As in previous years, states continued developing
  standards to accommodate residents with higher
  health care needs.

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2009 NCAL Regulatory Review

• 2008 trends include
• Changes to emergency/disaster preparedness and
  fire safety standards (including CA, CO, MD, MO,
  MS, OK, VA)
• Increased staff training requirements (including
  CO, CT, MD, VA, WA)
• Increased or modified medication management
  standards (including MD, NJ, RI, VA)
• Added or changed background check requirements
  (including GA, MD, MS, WA)
• Added disclosure standards (incl. CA, CO, MD)
• Added staffing requirements (including MD, MO).

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Federal Regulation of AL?

• Trend toward AL residents with more health needs
  and more residents with dementia is leading
  states to increase AL regulation, increasing
  pressure for greater uniformity of state
  regulation.
• Many leaders in the new Congress are on record as
  supporting greater federal oversight of AL (e.g.
  Henry Waxman, Pete Stark).
• NCAL will be at the table if a debate over
  federal regulation recurs.

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What NCAL is Doing to Prepare

• NCAL Keep AL Regulation at State Level
• White Paper.
• Matrix of Minimum State Standards.
• NCALs State Regulatory Review
• But Be Prepared for Debate over Federal
  Regulation.
• Regulatory Principles Document.
• Reed Smith Legal Analysis.

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Federal Agencies with Assisted Living Initiatives

• Centers for Medicare Medicaid Services (CMS)
• HHS Office of Inspector General (OIG)
• Environmental Protection Agency (EPA) (2
  projects)
• Office of the Assistant Secretary for Planning
  and Evaluation (ASPE)
• National Center for Health Statistics (NCHS/CDC)
• Agency for Healthcare Research Quality (AHRQ)

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AHRQs Consumer Disclosure Initiative

• In July 2008, AHRQ launched the Assisted Living
  Disclosure Collaborative. This 18-month project
  will result in a tool that would allow consumers
  to compare and select assisted living communities
  around the country.
• Four Workgroups have been formed to Develop the
  Tool
• AL Services and Costs
• Dementia Services
• Move In/Move Out and Resident Rights
• Staffing
• Final model tool to be completed by December
  2009.
• NCAL has a key leadership role in this
  initiative.

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Looking Ahead What is Clear

• E-Prescribing
• Electronic Health Records
• More on-line disclosure of information
• New service models and delivery sites
• Increasing acuity
• Increased state oversight
• Staffing challenges

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Looking Ahead What is Unclear

• Uniform assessments
• Uniform outcome measurements
• Federal regulation
• Legal changes
• The declining economys impact on assisted living

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www.ncal.org

• Access NCALs Members Only Web site.
• Included
• Assisted Living Research and Studies
• Labor, Workforce OSHA Resources
• Legislative Updates
• Life Safety Disaster Preparedness
  Information
• NCALs Guiding Principles
• NCALs Webinar Archive