PRESENTED BY;DAWN M. CARMAN, JD, RHIA, FACHE
DENALI COMPLIANCE GROUP, LLCT E M P O R A R Y E M A I L : D A W N C A R M A N @ G M A I L . C O M
( C O M PA N Y, W E B S I T E , A N D E M A I L A D D R E S S P E N D I N G )
Quality of Care: Top Concern for Health Lawyers?
Agenda
QualityCompliancePayersRegulators Enforcers
Disclaimer
The content of this presentation is for general education purposes only. It is not to be construed as legal advice. For specific questions and issue guidance, please contact an attorney.
Who Is In The Driver’s Seat?
Providers
Payers
Regulators Enforcers
Quality
Cost
Access
Consumers
Health Care Trends
Quality and patient safety Pay for Performance (P4P) Consumer driven health care Physician-hospital collaboration and competition Hospitalists Physician compensation arrangements Staffing shortages Heal yourself health care Retail clinic health care More regulations More enforcement
Quality
Quality Overview
Organized medical groups American Medical Association (1847) American College of Surgeons Hospital Standardization Program
(1917) Medical Group Management Association (1926)
Joint Commission (1952) Medical record audits (1966) Quality assurance (1979) Continuous quality improvement (1988)
Institute for Healthcare Improvement (IHI) (1991) Measurable goals
No needless deaths No needless pain or suffering No helplessness in those served or serving No unwanted waiting No waste
Quality Overview
Leapfrog Group (1998) Aims
Reduce preventable medical mistakes and improve the quality and affordability of health care
Encourage health providers to publicly report their quality and outcomes so that consumers and purchasing organizations can make informed health care choices
Reward physicians and hospitals for improving the quality, safety and affordability of health care
Help consumers reap the benefits of making smart health care decisions
Baldrige Award Six Sigma Toyota Lean
Quality Overview
Institute of Medicine Report (1999)To Err Is Human: Building a Safer Health
System Increased national awareness of health care
quality Emphasized patient safety Supported mandatory error reporting systems Set performance standards Estimated 98,000 people die annually due to
medical errors
Source: http://www.iom.edu/?id=12735
Quality Overview
Institute of Medicine Report (2001)Crossing the Quality Chasm: A New Health
System for the 21st Century Outlined how to reinvent the health care system
to foster innovation and improve the delivery of health care
Outcome measures for health care Safe Effective Patient-centered Timely Efficient Equitable
Source: http://www.iom.edu/CMS/8089.aspx
Compliance
Compliance Overview State licensing (late 1800’s) FDA federal medication regulation (1906) Social Security Act standards for maternal and children’s
health care services (1935) Hill-Burton Act (1946)
Federal grants and guaranteed loans for hospital construction Medicare Conditions of Participation (1965)
Medical staff credentialing Utilization review Physician fiscal responsibility
Joint Commission “deemed” status (1965) Professional Standards Review Organization (PSRO)
established to decrease hospital utilization (1972)
Compliance Overview Prospective Payment Systems (1983) Peer Review Organizations (PROs) (1983)
Inspect and detect approach To reduce readmission and unnecessary hospitalization To lower death and complication rates To identify physician quality of care issues Physicians concerned that PROs generated more paperwork than
improvement Health Care Quality Improvement Act (1986)
National Practitioner Data Bank Medical malpractice claims settlements and awards Hospital medical staff adverse actions
EMTALA (1986) Medical screening examination Necessary stabilizing treatment Regardless of ability to pay
Compliance Overview
CMS (formerly Health Care Finance Administration) Health Care Quality Improvement Initiative (1992) Changed PROs approach to data collection, its
quality of care evaluation criteria, and its role in implementing quality initiatives
Focus on practice patterns Evaluate quality using national, disease specific
guidelines Work collaboratively with hospitals and
physicians on quality improvement initiatives
Source: http://www.cms.hhs.gov/
Compliance Overview
DHHS OIG Compliance Guidance For Hospitals (1998) 7 elements of effective compliance program No “one size fits all” Goals
Optimize payment Minimize billing mistakes (erroneous v. fraudulent
claims) Decrease chances of audits Avoid conflicts with Stark and Anti-Kickback statutes
http://www.oig.hhs.gov/authorities/docs/cpghosp.pdf
Compliance Overview
OIG Compliance Guidance for Individual and Small Group Physician Practices (2000) 7 elements of effective compliance program No “one size fits all” Goals
Optimize payment Minimize billing mistakes (erroneous v. fraudulent
claims) Decrease chances of audits Avoid conflicts with Stark and Anti-Kickback statutes
http://www.oig.hhs.gov/authorities/docs/physician.pdf
OIG Compliance Guidance for Nursing Facilities (2000)
http://www.oig.hhs.gov/authorities/docs/cpgnf.pdf
Draft supplemental guidance pending (2008)
Compliance Overview
DHHS OIG Supplemental Compliance Guidance For Hospitals Risk assessments A more thorough discussion of compliance fraud and
abuse risk areas Internal controls into processes http://www.oig.hhs.gov/fraud/docs/complianceguidanc
e/012705HospSupplementalGuidance.pdf
The False Claims ActFalse Claims Act (1863)
An individual who knowingly submit, or cause another person or entity to submit, false claims for payment of government funds are liable for three times the government’s damages plus civil penalties of $5,500 to $11,000 per false claim
qui tam whistleblower provision Examples:
A contractor falsifies test results or other information regarding the quality or cost of products it sells to the Government;
A health care provider bills Medicare for services that were not performed or were unnecessary, or;
A grant recipient charges the Government for costs not related to the grant.
AK no state false claims act
The False Claims Act
The False Claims Act is about more than money. It is also about discouraging fraud and changing the culture of corporate America. As Sen. Charles Grassley (R-IA) and Rep. Howard Berman (D-CA) have noted:
"Studies estimate the fraud deterred thus far by the qui tam provisions runs into the hundreds of billions of dollars. Instead of encouraging or rewarding a culture of deceit, corporations now spend substantial sums on sophisticated and meaningful compliance programs. That change in the corporate culture -- and in the values-based decisions that ordinary Americans make daily in the workplace -- may be the law's most durable legacy."
Source: http://www.taf.org/whyfca.htm
Stark
A conflict of interest law (1989)Intent to keep providers from self-referring
patients for designated health services to facilities in which they have a financial relationship
Designed to keep hospitals and providers from defrauding Medicare
Penalties may include civil fines $15,000 - $100,000 or Medicare exclusion
Exceptions apply
Anti-Kickback Statute
Prohibits any knowing or willful solicitation or acceptance of any type of remuneration to induce referrals for health services that are reimbursable by the federal government (1972)
Criminal statuteFelonies with criminal penalties of up to
$25,000 in fines and five years in prisonCivil penalties can involve up to $50,000 in
fines and exclusion from federal program participation
Compliance Overview
Quality Improvement Organizations (QIOs) (2001) Expanded role of QIOs in quality improvement initiatives No published assessments of whether hospitals and physicians believe
QIO interventions are improving qualitySarbanes-Oxley Act of 2002
Impacts heath care organizations Applies to publicly traded health organizations Best practices useful for non-profit health organizations Impetus for enterprise risk management More reliable and relevant documentation is necessary for financial statements
and clinical quality measures US Sentencing Guidelines (2004)
Effective compliance and ethics program may reduce criminal sanctions Board of directors must be involved in compliance programs Adequate resources for compliance programs http://www.ussc.gov/press/rel0404.htm
Compliance Overview Deficit Reduction Act of 2005
Medicare and Medicaid Integrity Programs Gainsharing projects Hospital Quality Data Payment Update Program expansion http://www.cms.hhs.gov/DeficitReductionAct/
Tax Relief and Healthcare Improvement Act of 2006 Physician Quality Reporting Initiative 1.5% bonus for physician participants Quality measure registry reporting http://www.cms.hhs.gov/PQRI/Downloads/PQRITaxReliefHealthCar
eAct.pdf IPPS and OPPS Cuts Continue
IPPS $20B cut AHA said an “unnecessary and demoralizing blow against
hospitals’ ability to care for patients across America” http://www.aha.org/aha/press-release/2007/070801-st-finalippsrul
e.html
What Do Payers Want?
What Is P4P?
Payment model that rewards hospitals and physicians for achieving certain performance measures for quality and efficiency
Value-based purchasingConcept prevalent in other industriesGets away from resource-based fee-for-service
reimbursement leaves little incentive for quality improvement
Providers concerned that Clinical practice guidelines have not undergone clinical trials Patient non-compliance is out of their control P4P will lead to broken physician-patient relationships http://www.mgma.com/
P4P
CA P4P Project (2001) Emerged from CA health care plans and physician
groups developing a set of quality performance measures and a public report card the 1990s Financial incentives based on utilization management
were changed to quality measures
P4P
National Voluntary Hospital Reporting Initiative (NVHRI) Set forth in Medicare Modernization Act of 2003 Public-private joint effort 21 quality measures
P4P
Medicare Quality Monitoring System (MQMS) (2003) Part of CMS efforts to monitor and improve the quality of
care delivered to Medicare beneficiaries Early warning system for declines in quality of care Quality indicators provided to Medicare beneficiaries Utilization and outcome quality measures (as opposed to
process quality measures) for many areas http://www.cms.hhs.gov/QualityInitiativesGenInfo/15_MQM
S.asp
P4P
Medicare Quality Monitoring System (MQMS) Based on administrative data Trends from 1992 though 2001 Various clinical and topic areas
Characteristics of Medicare beneficiaries and their utilization of health care
Acute myocardial infarction Heart failure Stroke Pneumonia Cardiovascular surgeries Cancer surgeries
P4P
Medicare Quality Monitoring System (MQMS) National and state-level outcomes (not hospital-
level outcomes) Adjusted to a standardized distribution of age and
sex; not otherwise risk adjusted http://www.cms.hhs.gov/QualityInitiativesGenInfo/1
5_MQMS.asp
P4P
Premier Hospital Quality Demonstration (2006) 260 hospitals 34 quality measures Public reporting of data 2% or 1% bonus (49/260 received a bonus) 2% or 1% penalty http://www.cms.hhs.gov/HospitalQualityInits/35_hospi
talpremier.asp
P4P
The Physician Focused Quality Initiative (2004) Implemented to
Assess the quality of care for key illnesses and clinical conditions that affect Medicare patients
Support physicians in providing appropriate treatment of the conditions identified
Prevent health problems that are avoidable, and Investigate the concept of payment for performance http://www.cms.hhs.gov/PhysicianFocusedQualInits/
P4P
Doctor's Office Quality Project (DOQ) Designed to develop and test a comprehensive, integrated
approach to measuring the quality of care for chronic disease and preventive services in the doctor's offices
DOQ goals are to Provide information for informed decision making support and stimulate the adoption of quality improvement
strategies by practitioners in doctor's offices CMS is working closely with key stakeholders such as
nationally recognized physicians associations, consumer advocacy groups, philanthropic foundations, purchasers, and quality accreditation or quality assessment organizations to develop and test DOQ
http://providers.ipro.org/index/doqit
P4P
Medical Group Management Association (MGMA) “A pay-for-performance program that conforms to certain
established principles can potentially make health care programs more effective and efficient.”
9 principles Goal must be to improve quality and safety Physician participation must be voluntary Practicing physicians must be involved in program design Must use evidence-based performance measures Must use adjusted data Must reward physician participation Medicare P4P must not be budget neutral Must reimburse physicians for administrative costs Physicians must be able to review and correct performance
data
Source: http://www.mgma.org
P4P
Physician Group Practice Demonstrations (2005) Mandated by the Medicare, Medicaid, and SCHIP
by the Benefits Improvement and Protection Act of 2000 (BIPA)
First P4P initiative for physicians under the Medicare program
Rewards physician for meeting performance measures for quality outcomes and efficiency
Disincentives for medical errors Focused on large group practices (200+
physicians) http://www.cms.hhs.gov/apps/media/press/release
.asp?Counter=1341
P4P
Medicare Health Care Quality Demonstration (2006) Medicare Modernization Act mandated 5 year
demonstration program Projects designed to enhance quality by
Improving patient safety Reducing variations in utilization by appropriate use of
evidence-based care and best practice guidelines Encouraging shared decision making Using culturally and ethnically appropriate care
Eligible participants include physician groups and integrated health systems
http://www.cms.hhs.gov/demoprojectsevalrpts/md/list.asp
P4P
Physician Quality Reporting Initiative (PQRI) Voluntary pay for reporting program started in
2007 Based on the Tax Relief and Health Care Act of
2006 (TRHCA) Physicians collected and reported Medicare
practice data for 74 performance measures between July and December 31, 2007
Participating physicians reporting on at least three performance measures on 80% of the eligible patients through out the full calendar year will receive a bonus from CMS
Challenges for sole practitioners http://www.cms.hhs.gov/pqri/
P4P
Physician Quality Reporting Initiative (PQRI) PQRI continues for January 1 through December
31, 2008 2008 PQRI quality measure specifications
http://www.cms.hhs.gov/PQRI/downloads/2008PQRIQualityMeasureSpecs123107.pdf
CMS physician education article on PQRI http://www.cms.hhs.gov/MLNMattersArticles/downloads/
MM5640.pdf PQRI is considered by some experts to be a
precursor to mandatory pay for performance (P4P)
P4P
Physician Quality Reporting Initiative (PQRI) 2008 PQRI Coding For Quality Handbook provides coding
and reporting principles and describes successful reporting for each measure: http://www5.mgma.com/ecom/default.aspx?tabid=64&dest=htt
p%3a%2f%2fwww.mgma.com%2fWorkArea%2fshowcontent.aspx!id%3d15736%7cRef%3dhttpzx0zx1zx1www.mgma.comzx1policyzx1default.aspxzx2idzx415570
CMS and AMA jointly developed PQRI data collection worksheets http://www.ama-assn.org/ama/pub/category/17432.html
119 quality measures http://www.cms.hhs.gov/PQRI/Downloads/2008PQRIMeasuresLi
st.pdf?agree=yes&nex http://www.cms.hhs.gov/PQRI/15_MeasuresCodes.asp#TopOfPa
ge
P4P
Medicare Care Management Performance Demonstration (2007) Modeled on the “Bridges to Excellence” program A 3 year P4P demonstration with physicians to promote the
adoption and use of health information technology to improve the quality of patient care for chronically ill Medicare patients
Physicians who meet or exceed CMS performance standards in clinical delivery systems and patient outcomes will receive bonus payments for managing eligible Medicare beneficiaries
Focused on smaller practices in 4 states http://www.cms.hhs.gov/DemoProjectsEvalRpts/downloads/
MMA649_DesignReport.pdf
CMS Quality Focus
CMS Hospital Quality Initiative Update Accountability Transparency
Hospital Compare www.hospitalcompare.hhs.gov
Patients get Quality information Patient satisfaction information Pricing information
OIG Quality And Compliance
DHSS OIG/AHLA Guidance (2007) Corporate Responsibility and Health Care Quality: A
Resource For Health Care Boards of Directors Designed for health care organization boards Consumers are demanding greater transparency and information
about the care they receive Medicare and other payors are linking payment to quality of care Physicians are striving to deliver the highest quality care Regulators are making health care quality a priority Offers questions related to health care quality requirements,
measurement tools, and reporting requirements that may be useful to those looking at quality of care issues
http://oig.hhs.gov/fraud/docs/complianceguidance/CorporateResponsibilityFinal%209-4-07.pdf
OIG Quality And Compliance
Board of directors oversight of quality of careDuty of careGood faithReasonable person Best interest of organizationReasonable inquiry standardBalance between second guessing and due
diligence
OIG Quality And Compliance
DHHS OIG/HCCA Long Term Care Quality Guidance
Driving For Quality In Long Term Care: A Board of Directors Dashboard (2007)
http://www.oig.hhs.gov/fraud/docs/complianceguidance/Roundtable013007.pdf
OIG Quality And Compliance
Board of directors oversight of quality of careDashboard toolsLegal perspectivesClinical perspectivesCommitment to qualityProcesses to monitor and improve qualityFocus on quality outcomes
Health Law Trend
Health Care Quality Tops List of Health Law Issues for 2008, says BNA Survey of Leading Health Law Attorneys
NEWS RELEASE
Arlington, Va. (January 7, 2008) – Patient care quality ranks at the top of the list of health law issues for 2008, according to an informal survey of health law attorneys by BNA's Health Law Reporter ™. Quality of care supplants fraud and abuse, which held the top spot for the previous two years.
Source: American Health Lawyers Association
EnforcementMedicare/Medicaid Conditions of Participation
The medical staff is accountable to the board to monitor quality Corporate Integrity Agreements Program exclusion
Joint Commission Deemed status substitute for COP Loss of accreditation
Government approach to improve quality in health care Public reporting Enforcing quality through the False Claims Act Incentivizing quality through payment reform
State Medicaid enforcement increases CMS increases Medicaid integrity programs See NY Medicaid Inspector General efforts http://www.omig.state.ny.us/data/
Enforcement
OIG, DOJ, and State Attorneys General Working together to enforce quality Focus on medical necessity and failure of care Penalties
$ fines Criminal sanctions Prison Federal and state program exclusion Corporate Integrity Agreements
FCA Prosecution Categories
Ordering medically unnecessary servicesPayments of kickbacksSpecial treatment for frequent admittersFraudulent documentationLack or failure of appropriate internal review
processesUnderlying regulatory violations
Source: C. Wagonhurst et al., Compliance and the Quality of Care Revolution, Health Lawyers News, Oct. 2007.
FCA Prosecutions
Automatically running a lab test whenever the results of some other test fall within a certain range, even though the second test was not specifically requested
Defective testing - Certifying that something has passed a test, when in fact it has not
"Lick and stick" prescription rebate fraud and "marketing the spread" prescription fraud, both of which involve lying to the government about the true wholesale price of prescription drugs
Unbundling - Using multiple billing codes instead of one billing code for a drug panel test in order to increase remuneration
Bundling -- Billing more for a panel of tests when a single test was asked for
Double billing - Charging more than once for the same goods or service
Upcoding - Inflating bills by using diagnosis billing codes that suggest a more expensive illness or treatment
Billing for brand -- Billing for brand-named drugs when generic drugs are actually provided
Source: The False Claims Act Legal Center http://www.taf.org/whyfca.htm
FCA Prosecutions
Automatically running a lab test whenever the results of some other test fall within a certain range, even though the second test was not specifically requested
Defective testing - Certifying that something has passed a test, when in fact it has not
"Lick and stick" prescription rebate fraud and "marketing the spread" prescription fraud, both of which involve lying to the government about the true wholesale price of prescription drugs Lick and stick: pharmaceutical companies sold drugs at a discount to HMOs but did not afford state Medicaid
programs the same rebates Source: http://www.namfcu.net/press/press-release-2003-04-16/ Marketing the spread: pharmaceutical companies discount physician-administered drugs then the physicians
charge government or private insurer more, pocketing the difference Source: http://usawhistleblower.com/reportpharmafraud.html
Unbundling - Using multiple billing codes instead of one billing code for a drug panel test in order to increase remuneration
Bundling -- Billing more for a panel of tests when a single test was asked for Double billing - Charging more than once for the same goods or service Upcoding - Inflating bills by using diagnosis billing codes that suggest a more
expensive illness or treatment Billing for brand -- Billing for brand-named drugs when generic drugs are actually
provided
Source: The False Claims Act Legal Center http://www.taf.org/whyfca.htm
FCA Prosecutions
Phantom employees and doctored time slips: Charging for employees that were not actually on the job, or billing for made-up hours in order to maximize reimbursements
Upcoding employee work: Billing at doctor rates for work that was actually conducted by a nurse or resident intern.
Yield burning -- skimming off the profits from the sale of municipal bonds
Falsifying natural resource production records -- Pumping, mining or harvesting more natural resources from public lands that is actually reported to the government
Being over-paid by the government for sale of a good or service, and then not reporting that overpayment
Misrepresenting the value of imported goods or their country of origin for tariff purposes
False certification that a contract falls within certain guidelines (i.e. the contractor is a minority or veteran)
Source: The False Claims Act Legal Center http://www.taf.org/whyfca.htm
FCA Prosecutions
Billing in order to increase revenue instead of billing to reflect actual work performed
Failing to report known product defects in order to be able to continue to sell or bill the government for the product.
Billing for research that was never conducted; falsifying research data that was paid for by the U.S. government.
Winning a contract through kickbacks or bribes Prescribing a medicine or recommending a type of treatment
or diagnosis regimen in order to win kickbacks from hospitals, labs or pharmaceutical companies
Billing for unlicensed or unapproved drugs Forging physician signatures when such signatures are
required for reimbursement from Medicare or Medicaid
Source: The False Claims Act Legal Center http://www.taf.org/whyfca.htm
Quality Case Law
See Redding Medical Center Unnecessary heart procedures FCA Settlement $54M Required divestment from corporate parent Corporate Integrity Agreement put in place
See Lady of Lourdes Medical Center Unnecessary medical procedures FCA Settlement $3.8M Corporate Integrity Agreement put in place
Source: C. Wagonhurst et al., Compliance and the Quality of Care Revolution, Health Lawyers News, Oct. 2007.
DHHS OIG
Going full speed ahead with enforcement efforts in quality of care
Sharing enforcement tools with statesDRA whistleblower rights awarenessData mining for reimbursement and quality
of careFocus on system failuresCorporate Integrity Agreements
Fiscal integrity Quality of care
Never events $
Data Mining
Technology to sort patient data to identify poor quality of care providers Looks for quality patterns Looks for fraud, waste, and abuse Hospital Quality Initiative Program for Evaluating Payment Patterns
Electronic Report (PEPPER) Comprehensive Error Rate Testing (CERT) Payment Error Rate Measurement (PERM) Recovery Audit Contractors (RACs)
Enforcement
Historical enforcement False Claims Act Stark Anti-Kickback Statute Corporate Integrity Agreements
New enforcement Deferred prosecution agreements Resolve criminal investigations
Cooperate with government Waive right to speedy trial and statute of limitations Take systematic remedial measures Independent monitor
Examples Medical device company paying consultants to use its products A medical center double billing Medicaid
Q&A