hospice regulatory update: the new norm judi lund person, mph nhpco © nhpco, 2013 1
TRANSCRIPT
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Objectives
Sequestration Basic hospice data List the five most current regulatory issues facing hospices
today Describe quality reporting requirements and deadlines Discuss the proposed quality measures and surveys discussed
for future implementation and preparation for use in 2013/2014
Identify major players in hospice audits and review and discuss the risk areas for hospices
Describe the FY2013 Office of Inspector General Workplan for hospice
Identify strategies to fine tune compliance plans, develop policies, procedures and protocols to address priority risk areas
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New Study on Hospice Cost Effectiveness
Author Amy S. Kelley, MD, MSHS Published in Health Affairs, March 2013 Findings:
Most common hospice enrollment periods: 1 to 7 days, 8 to 14 days, 15 to 30 days, and 53 to 105 days.
All enrollment periods – significantly lower rates of: hospital and intensive care use hospital readmissions in-hospital death
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New Study on Hospice Cost Effectiveness
Savings for both cancer and non-cancer patients
Savings appear to grow as length of stay lengthens – to 105 days, the end of the study period.
Investment in the Medicare Hospice Benefit translates into savings overall for the Medicare system. “If 1,000 additional beneficiaries enrolled in
hospice 15 to 30 days prior to death, Medicare could save more than $6.4 million.”
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Patients Served by Hospice in the US 1982-2011
- 200,000 400,000 600,000 800,000
1,000,000 1,200,000 1,400,000 1,600,000 1,800,000
Number of Patients
Number of Patients
Source: National Hospice and Palliative Care Organization, 2012
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Number of Hospices
1985
1990
1996
1999
2003
2005
2007
2008
2009
2010
2011
0500
1000150020002500300035004000
Number of Hospices
Number of Hospices
Source: Centers for Medicare and Medicaid Services, 2011 Data Compendium
Diagnoses of Hospice Patients2011
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Cancer 35.6%
Debility Unspecified 13.0%Dementia
13.0%
Heart Disease 14.3%
Kidney Disease 2.4%
Liver Disease 1.9%
Lung Disease 8.3%
Stroke or Coma 4.2%
Other 5.4% Motor Neuron; 1.6% HIV/AIDS, 0.3%
Source: National Hospice and Palliative Care Organization, 2012
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Length of Service in Hospice
Average Length of Stay Median Length of Stay0
10
20
30
40
50
60
70
80
67.4
20.0
69.5
21.3
69
21.1
67.4
19.7
69.1
19.1
2007 2008 2009 2010 2011
Day
s of
Car
e
Source: National Hospice and Palliative Care Organization, 2012
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Percentage of days by level of care Routine home care 97.3% General inpatient 2.0% Continuous home care 0.5% Respite 0.2%
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Rate cuts already in place
FY2013 Rates
The cap amount is set at $25,377.01 for the cap year ending October 31, 2012
Final hospital marketbasket update for FY2013 2.6%
Less productivity reduction adjustment -0.7%
Less additional hospice-specific productivity adjustment -0.3%
FY2013 rate increase 1.6%
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Sequestration impact, if…..
2% reduction for services provided on or after April 1, 2013
Bill at the FY2013 rate Contractor will apply 2% reduction with
payments
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Preparing your hospice for rate cuts…
Streamline operations Staffing and staff caseloads Service area reductions Reduce services without affecting
patient care Increase charitable giving
Advocacy focus for 201320
Vigilance Hill presence CMS presence Unified message on the Hill
Never more important than this year!
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HELP legislation
Working to reintroduce in 2013: Expand the list of health care professionals
to conduct the face-to-face to include: Physician assistants Clinical nurse specialists
Will expand the timeframe for completion of face-to-face to up to 7 days after admission
Will require a two year pilot of payment reform before finalizing
Will require hospices to be surveyed every three years
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Hospice Payment Reform
ACA provision: Reform hospice payments no earlier than FY2014
Analysis of data currently underway CMS contractors continue to analyze
Claims data Hospice cost reports
Technical Expert Panel continues deliberations
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Analysis of what?
Live discharges Rate of GIP utilization and LOS at GIP Drugs billed to Part D
What are the drugs? Who are the hospices? Who are the pharmacies?
Multiple diagnoses
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Models
U-shaped curve Higher payments at the beginning of care Higher payments at the end of care Lower payments in the middle of care
Other options Goal: to align payments with cost of
services
Eligibility for Admission Medicare Hospice Benefit
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§ 418.20 Eligibility requirements. In order to be eligible to elect hospice
care under Medicare, an individual must be-- (a) Entitled to Part A of Medicare; and (b) Certified as being terminally ill in
accordance with Sec. 418.22.
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Compliance “Hot Spots”
Eligibility of hospice patients Initial Ongoing Physician narrative
Certain non-cancer diagnosis Dementia/ Alzheimer's Debility unspecified
Level of care documentation GIP
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MAC Compliance “Hot Spots”
Eligibility of hospice patients Ongoing Physician narrative
Certain non-cancer diagnosis – evidencing 6 month or less prognosis Dementia/ Alzheimer's Debility unspecified
Level of care documentation GIP – eligibility for all days billed at GIP
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Opportunities to document eligibility Certification
Verbal certification Written certification Physician narrative statement
Admission Comprehensive assessment
Ongoing hospice service Every note by the IDT Update to the comprehensive assessment
Recertification F2F encounter Physician narrative statement
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Eligibility - 1st 90-day period
Demonstration of eligibility at admission Information/ consultation between attending
physician and hospice physician
Procurement of medical history and recent clinical documentation For the clinical record For use in the certification process
Attending physician and hospice physician certify patient based on their medical judgment of the disease progression
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Eligibility - 1st 90-day period
Demonstration of eligibility at admission Physician narrative should concisely
describe why the patient is initially eligible for hospice
Comprehensive assessment documentation by IDG should evidence the details of the patient’s eligibility
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Eligibility – Continued and at Recertification
Demonstration of eligibility at recertification Physician narrative should concisely
describe why the patient is continues to be eligible for hospice
Clinical note from face-to-face visit demonstrates eligibility (if 3rd of subsequent benefit period)
Update to the comprehensive assessment documentation by IDG should evidence the details of the patient’s continued eligibility
Certification/ Recertification36
NHPCO Certification/ recertification Process Maps available for purchase
in NHPCO’s Marketplace
Co-morbidities
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Chronic obstructive pulmonary disease
Congestive heart failure Ischemic heart disease Diabetes mellitus Neurologic disease (CVA,
ALS, MS, Parkinson’s)
Although not the primary hospice diagnosis, the presence of disease such as the following…should be considered in determining hospice eligibility
• Renal failure• Liver Disease• Neoplasia• Acquired immune
deficiency syndrome• Dementia
Local Coverage Determination Policies (LCDs)
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GUIDELINES, not regulations: Developed by each MAC (CGS, NGS, NHIC,
Palmetto) Outline guidelines for condition-specific
determination of eligibility Discuss documentation of secondary
diagnoses and co morbid conditions to support terminal prognosis
Local Coverage Determination Policies (LCDs)
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More emphasis on functional decline in the updated LCDs Must have details to document the
extent of decline Need to consider the impact of
disease on patient’s quality of life Be familiar with the LCDs that are
used in medical review for your region
Documentation Using LCDs
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Documentation needs to address: Impairments in function & structure Activity limitations Participation restrictions Secondary diagnoses Co-morbid conditions
Documentation Using LCDs
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Address the patient’s activity level, self care, communication, and mobility
Give a historical perspective of what the patient’s ability was in the previous time period and then document current status
BUT REMEMBER… Decline eligibility Decline necessary or sufficient
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Documentation Using LCDs
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Use specifics to show the extent of the symptoms and limitations
Use the term “as evidenced by” to qualify the problems
Include symptoms such as wt loss, decubitus ulcers, & edema
Co-morbid conditions such as CHF, COPD and diabetes affect prognosis
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The physician narrative
Components of a comprehensive and adequate physician narrative should include: Explanation of the clinical findings that
supports a life expectancy of 6 months or less
Reference to specific LCDs as appropriate
Reference to prognostic indicators or symptom management sales as appropriate
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The physician narrative
Components of a comprehensive and adequate physician narrative should include: Reference to functional status
PPS - Validated in palliative care ECOG - Cancer Karnofsky - Cancer FAST - Dementia
Being specific is the most important thing: don’t say that the patient has lost weight – state that there has been a 15 pound weight loss in the past 2 months and 45 pounds in the last 6
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The physician narrative
Components of a comprehensive and adequate physician narrative should include: Evidence of a decrease in anthropomorphic
measurements Recent hospitalizations Information about other significant complications in
addition to the LCD specific criteria appropriate for that particular diagnosis
Statement should be concise, but adequate Statement should contain prognostic
indicators
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§418.56 Condition of participation: Interdisciplinary
group, care planning, and coordination of services
#147
§418.56(b) Standard: Plan of care
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L543 All hospice care and services furnished to
patients and their families must follow an individualized written plan of care established by the hospice interdisciplinary group in collaboration with the attending physician (if any), the patient or representative, and the primary caregiver in accordance with the patient’s needs if any of them so desire
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L543 deficiency examples49
Examples: The POC listed hospice aide services 2x/wk.
During a 6 wk period, the aide was provided 1 time.
POC included SW every 2 weeks, the SW visits were provided once a month.
POC included SW Q2 weeks; the SW went once in a 7 week period.
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§418.76(h) Standard: Supervision of hospice aides
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L629 (1) A registered nurse must make an on-
site visit to the patient’s home: (i) No less frequently than every 14 days to
assess the quality of care and services provided by the hospice aide and to ensure that services ordered by the hospice interdisciplinary group meet the patient’s needs. The hospice aide does not have to be present during this visit.
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L629 deficiency example52
Intervals of 17 days, 18 days and 20 days were noted.
Failure of the RN to provide aide supervision at least every 14 days placed the patients at risk for having their personal needs adequately met.
Supervision by LPNs
Remember! If the RN makes a supervisory visit on a Tuesday, the next supervisory visit is due by the Tuesday, which occurs 14 days later
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§418.56 Condition of participation: Interdisciplinary
group, care planning, and coordination of services
#353
§418.56(c) Standard: Content of the plan of care
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L545 The hospice must develop an individualized
written plan of care for each patient. The plan of care must reflect patient and family goals and interventions based on the problems identified in the initial, comprehensive, and updated comprehensive assessments. The plan of care must include all services necessary for the palliation and management of the terminal illness and related conditions
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L545 deficiency example55
Elderly pt with lung cancer that lived alone. Initial visit a goal was developed for comfortable breathing pattern without distress.
2 months later the SN visited and taught oxygen use. 2 days later during an RN visit, the pt was trying the oxygen to see if it helps.
The following day the chaplain visited and described the pt as upset. The chaplain documented that the landlady was upset that the pt had oxygen in her apartment. The chaplain assisted the pt to call the DME company to have the oxygen removed.
There was no indication that the chaplain contacted the SN/case manager or the MD regarding the pt’s concerns and wishes to discontinue the oxygen.
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§418.54(c)(6) - Drug profile 57
L530 A review of all of the patient's prescription and
over-the-counter drugs, herbal remedies and other alternative treatments that could affect drug therapy. This includes, but is not limited to, identification of the following:
i. Effectiveness of drug therapy ii. Drug side effects iii. Actual or potential drug interactions iv. Duplicate drug therapy v. Drug therapy currently associated with laboratory
monitoring
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L530 deficiency examples58
The hospice failed to ensure a review of medications on the initial comprehensive assessment for 8 of 8 patients. This was confirmed with clinical record review and interviews with the administrator.
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§418.56(e) Standard: Coordination of services
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The hospice must develop and maintain a system of communication and integration, in accordance with the hospice’s own policies and procedures, to- (1) Ensure that the interdisciplinary group
maintains responsibility for directing, coordinating, and supervising the care and services provided.
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§418.56(e) Standard: Coordination of services
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L555- Ensure that the care and services are provided in accordance with the plan of care.
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L555 deficiency examples62
A pt residing in an ALF did not receive 2 medications (Lasix and Spirolactone) in accordance with the POC. The patient was on automatic refills but because there were temporary changes to the dosages the auto refills were placed on hold.
The pt went without these meds for approximately one month. As soon as the RN realized, she contacted the MD and both meds were resumed.
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§418.64(b) Standard: Nursing services
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L591(1) The hospice must provide nursing care and services by or under the supervision of a registered nurse. Nursing services must ensure that the nursing needs of the patient are met as identified in the patient’s initial assessment, comprehensive assessment, and updated assessments.
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L591 deficiency examples65
No measurements of wounds. A hospice aide was changing the dressings to
a patient’s neck and around the feeding tube on a regular basis. The RN was aware of this practice although the RN never instructed her to do this; she acknowledged that she knew this was happening. These dressing changes were outside the scope of the hospice aide’s practice. No evidence in the clinical record that the RN provided any wound care or assessment.
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§418.56 Condition of participation: Interdisciplinary
group, care planning, and coordination of services
#766
§418.56(d) Standard: Review of the plan of care
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L552 The hospice interdisciplinary group (in
collaboration with the individual’s attending physician, if any) must review, revise and document the individualized plan as frequently as the patient’s condition requires, but no less frequently than every 15 calendar days
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L552 deficiency example68
For 3 of 6 patient’s clinical records reviewed the plans of care were reviewed on a monthly basis. There policy was for an every 14 day review.
For 5 of 10 patients, the regulation was not followed. The length of time between reviews ranged from 19 to 33 days. The agency policy was for every 2 weeks.
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§418.64 Condition of participation: Core services
2nd year citation since implementation of 2008 CoPs
#869
§418.64(d) - Counseling services Bereavement counseling.
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L596 (1) - Bereavement counseling. The hospice
must: (i) Have an organized program for the provision of
bereavement services furnished under the supervision of a qualified professional with experience or education in grief or loss counseling
(ii) Make bereavement services available to the family and other individuals in the bereavement plan of care up to 1 year following the death of the patient. Bereavement counseling also extends to residents of a SNF/NF or ICF/MR when appropriate and identified in the bereavement plan of care
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§418.64(d) - Counseling services Bereavement counseling
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L596 (1) - Bereavement counseling. The
hospice must: (iii) Ensure that bereavement services reflect the
needs of the bereaved. (iv) Develop a bereavement plan of care that
notes the kind of bereavement services to be offered and the frequency of service delivery.
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L596 deficiency examples72
Bereavement files in the survey sample failed to contain a bereavement reassessment or bereavement plan of care for the deceased patient’s family
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§418.76(c) Standard: Competency evaluation
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L615 An individual may furnish hospice aide services on behalf of
a hospice only after that individual has successfully completed a competency evaluation program as described in this section.
§418.76(c)(1) - The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (b)(3)(iii), (b)(3)(ix), (b)(3)(x) and (b)(3)(xi) of this section must be evaluated by observing an aide’s performance of the task with a patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a hospice aide with a patient.
7474
L615 deficiency examples75
The hospices policy was to review the skills of the aides 90 days after hire. 4 of the 4 files had no evidence of a skills check at the 90 days per agency policy.
There was no evidence of a skills checklist at the time of hire, either in practice or in policy.
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§418.54(b) Standard: Timeframe for completion of the comprehensive assessment
77
L523 The hospice interdisciplinary group, in
consultation with the individual’s attending physician (if any), must complete the comprehensive assessment no later than 5 calendar days after the election of hospice care in accordance with §418.24.
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L523 deficiency example78
No nursing or psychosocial assessment documented in 5 calendar days
Entire comprehensive assessment completed by 7 days
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CY2013 QUALITY REPORTING
Measures for quality reporting:
NQF #0209 Pain Measure Structural Measure
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CY2013 QUALITY REPORTING
1. NQF #0209: Comfortable Dying (NHPCO)
Percentage of patients who were uncomfortable because of pain at the initial assessment (after admission to hospice services) whose pain was brought to a comfortable level within 48 hours.
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CY2013 QUALITY REPORTING
Structural Measure:
Participation in a QAPI program that includes at least 3 quality indicators related to patient care
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CY2013 QUALITY REPORTING
QAPI Structural MeasureSubmission = Indication if hospice has a QAPI program
that includes at least three indicators related to patient care; and
Measures are used during reporting period
Description of all quality indicators related to patient care.
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CY2013 QUALITY REPORTING
QAPI Structural Measure
No results are submitted -- only the patient care measure descriptions
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Hospice Quality Reporting
The data collection period is January 1 – December 26 of each year
Reporting is mandatory Data due April 1 of each year 2013 measures remain the same as
2012
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Miss the deadlines?
Mandatory reporting Measures required – no choice in
what measures should be reported Miss the 2013 reporting deadlines?
Deadlines HAVE NOT been extended
2% cut in hospital market basket increase (hospice reimbursement rate “inflation adjustment”) in FY2014
CMS RESOURCES
CMS Hospice Quality Reporting web page Information posted on CMS web site as it becomes available
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/index.html
Download PowerPoint presentations and hospice quality questions and answers:
http://www.cms.gov/Hospice-Quality-Reporting/
Help Desk: [email protected] or by phone at 1.800.647.9670.
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NHPCO RESOURCES
Basic Information and Materials
www.nhpco.org/outcomemeasures
www.nhpco.org/qualityreporting
Questions – send email to:
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Payment Year FY2015
NQF #0209: Percentage of patients who report being uncomfortable because of pain on the initial assessment (after admission to hospice services) who report pain was brought to a comfortable level within 48 hours
Structural measure: Participation in a Quality Assessment and Performance Improvement (QAPI) program that includes at least three quality indicators related to patient care. Hospices would report whether or not they have a QAPI program with at least three indicators related to patient care.
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Data Collection Period
Calendar year – January 1, 2013 through December 26, 2013
Hospices submit data in the fiscal year prior to the payment determination.
For FY2015 and beyond: Data submission deadline of April 1of each year.
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Payment Year FY2015
No additional measures Creation of a hospice patient-level data
item set Target date for implementation: CY2014
Data items included in standardized data set to support possible measures
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Patient level data collection
Mandatory data collection process being designed to collect data on individual hospice patients – demographics, diagnoses, symptoms
Used to collect data for future quality reporting
Expect to see a form and process in 2014 or 2015
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STANDARDIZED DATA ITEM SET
CMS developing standardized assessment instrument
Many items standardized and used by other providers
Some items developed specifically for hospice Developed to collect information for hospice-
appropriate quality measures Pilot testing with 9 hospices summer/fall 2012 Propose to implement hospice patient-level
data item set as early as CY 2014
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Payment Determinations beyond FY2015
Possible measures – implemented in future rulemaking 1617 Opioid with bowel regimen 1634 Pain screening 1637 Pain assessment 1638 Dyspnea treatment 1639 Dyspnea screening
0208 Family Evaluation of Hospice Care
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VALUE BASED PURCHASING
Value based purchasing – pilot testing Utilize already implemented measures Implement pilot by January 1, 2016
Part D and Hospice
OIG report issued in 2012 Some Medicare hospice beneficiaries receiving
hospice care also had drugs paid for under Part D Scope of the problem:
198,543 hospice beneficiaries 677,022 prescription drugs through Part D Drugs should have been covered by the hospice? Part D paid pharmacies $33,638,137 Beneficiaries paid $3,835,557 in copayments
Expect additional scrutiny for Part D payments
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Recent Analysis
Analgesics only 2010 information
773,168 Medicare hospice beneficiaries enrolled in Part D
112,555 (14.6%) received 334,387 analgesic prescriptions through Part D during hospice enrollment
Gross costs -- $13,000,430 Examples of drugs: Fentanyl, oxycodone,
morphine, hydrocodone, hydromorphone….
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Recent Analysis
Location of patients? 63% in nursing facilities and assisted living 35% at home
Which hospices? 96.7% of hospices billed some analgesics to
Part D Which pharmacies?
40.9% of pharmacies
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CMS Draft 2014 Call Letter
Questions about eliminating Part D payments for Medicare hospice patients
Comments submitted March 1 2013 Proposing January 2014:
Part D sponsor who receives report that a beneficiary has elected the Medicare Hospice benefit
Sponsor place beneficiary-level prior authorization requirement for four categories of prescription drugs
Four categories: Analgesics antinauseants (antiemetics) Laxatives antianxiety
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Multiple diagnoses on claim form
Requirement is not new Clarification in FY 2013 Final Hospice
Wage Index Rule Analyses by CMS hospice contractor, showed
that 77.2% of hospice claims from 2010 only reported a principal diagnosis
CMS believes that hospice claims which only report a principal diagnosis are not providing an accurate description of the patients’ conditions
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Multiple diagnoses on claim form
Providers should code and report coexisting or additional diagnoses to more fully describe the Medicare patients they are treating CMS’ Hospice Claims Processing manual
requires that hospice claims include other diagnoses “as required by ICD-9-CM Coding Guidelines” (IOM 100-04, chapter 11, section 30.1, available at http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c11.pdf)
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Multiple diagnoses on claim form
CMS clarifies that all of a patient’s coexisting or additional diagnoses s should be reported on the hospice claim paper UB-04 claim allows for up to 17
additional diagnoses electronic claim allows for 24 additional
diagnoses
Hospices should not report diagnoses which are unrelated to the terminal illness on their claims
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Mixed messages from CMS
CMS is asking for all coexisting diagnoses and comorbidities
Often significant and used to make the case in the narrative for 6 month life expectancy
Example: Patient with heart failure Significant COPD and Parkinson’s disease COPD and Parkinson’s contributing to decline “Unrelated” to the heart failure Previously instructed not to include these very
significant but unrelated diagnoses on claim form
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The issues
Diagnoses definition inconsistency by CMS Related Co-morbid Secondary
Many EMR software solutions do not allow more that one diagnosis (5010 allows 25 spaces)
Payment for non-related dx; concern of providers
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Corollary issues
If diagnosis on claim form…. Hospice responsible for paying for drugs, DME,
supplies related to diagnosis CMS will expect hospice to pay for all or nearly
all drugs, DME, supplies for broad diagnoses Debility Adult Failure to Thrive Others
Determining relatedness…..
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Joint task force – NHPCO & NAHC
Task force goals Refine diagnoses definitions and seek
clarification from CMS Develop a resource to assist hospice
providers to determine relatedness Diagnoses Medications Other supplies and services
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Provider responsibility
Medicare does not pay for medical items/services furnished to an alien beneficiary who was not lawfully present in the United States on the date of service that the items/services were furnished
Common Working File will indicate alien status for unlawfully present in the US
MAC will retroactively adjust previously paid claims
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PEPPER Report
The Program for Evaluating Payment Patterns Electronic Report (PEPPER) second report
Available April 2013 FedEx to the hospice CEO Hospice-specific data statistics
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PEPPER Details
CMS sets PEPPER focus areas Services at risk for improper payments Three years of claims data Hospices can use the data to support internal
auditing and monitoring activities PEPPER compares a hospice’s Medicare billing
practices with other hospices in the: State Medicare Administrative Contractor (MAC)
jurisdiction US
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PEPPER Details
Time frame for claims: October 1, 2009 – September 30, 2012
Additional claims for period October 1, 2007 – September 30, 2009 included for episodes of service beginning prior to the reporting period
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PEPPER Details
Each hospice receives only its PEPPER Not available to the public Contractor provides Access database
with PEPPER data to MACs, Recovery Audit Contractors
Pay attention to any findings at or above the national 80th percentile
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Focus of PEPPER Report
Beneficiaries whose episode of service ends in the reporting year, either by live discharge or death.
Two focus areas: “Live Discharges” includes all episodes
where the beneficiary was discharged alive with a length of stay less than 25 days
“Long Length of Stay” counts beneficiary episodes of service that had a long length of stay -- greater than 180 days
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The final omnibus rule
The final omnibus rule was published in the January 17, 2013 Federal Register http://www.gpo.gov/fdsys/pkg/FR-2013-01-25/pd
f/2013-01073.pdf Compliance with most of the new
requirements introduced in the Final Rule is required by September 23, 2013
An extended compliance period is provided for the modification of certain existing business associate agreements
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When is compliance required?
Effective date: This final rule is March 26, 2013
Compliance date: Covered entities and business associates must comply with the applicable requirements of this final rule by September 23, 2013
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New rule
Changes greatly enhance a patient's privacy rights and protections
Strengthens the ability of Office of Civil Rights to vigorously enforce the HIPAA privacy and security protections
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New Breach Standard
Substantial change to the definition of a “breach” of protected health information (PHI)
New standard defines any impermissible acquisition, access, use or disclosure of PHI under the Privacy Rule is a breach unless a covered entity or business associate can demonstrate that there is a low probability that the PHI has been compromised Entities determine whether there is a low
probability that PHI has been compromised by performing a risk assessment
125
New Breach Standard
This modification to the definition of breach will make it more difficult for covered entities and business associates to justify a decision not to provide notification following a suspected breach incident
Following a breach, covered entities are still required to notify affected individuals, the Secretary of HHS, and the media (if a breach affects more than 500 residents of a State or jurisdiction) The current timing, content and methods for
notification also remain unchanged
126
New Breach Standard
HHS intends to issue guidance to aid
covered entities and business associates
in performing risk assessments and to
assist with the individual notification
requirements at a future date
127
Expanded Individual Rights
Individuals’ rights expanded with respect to their PHI in two important ways1. It provides them with the right to receive
certain PHI electronically2. It allows them to restrict certain
disclosures of PHI to their health plans Hospice providers will have to revise their
current policies and procedures and evaluate current system capabilities to ensure compliance with these new requirements
128
Expanded Individual Rights
The Final Rule also provides individuals with the right to request that covered entities and business associates provide a copy of their PHI directly to a designated individual
This right applies to both paper and electronic information
Any such request must be in writing, signed by the individual, and must clearly identify the designated recipient and where the information should be sent
129
Expanded Individual Rights
Restriction of certain disclosures of PHI to their health plans
Hospice providers will likely need to develop a method to flag or include a notation in the record of any individual who has exercised this right to restrict disclosures regarding services paid for out of pocket, in order to ensure that specific records are not sent or made accessible to health plans
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Modifications to Notices of Privacy Practices Required
Privacy notices must include a statement regarding the right of affected individuals to be notified following a data breach and must describe certain uses and disclosures of PHI that require patient authorization related to psychotherapy notes, marketing, and the sale of PHI
The Notice must also inform patients of their right to restrict certain disclosures of PHI to health plans where the individual pays out of pocket in full
131
Direct Liability for Business Associates and Amendments to Business Associate Agreements
Business associates and business associate subcontractors will now be directly subject to applicable HIPAA rules including the HIPAA Security Rule and certain
provisions of the Privacy Rule HHS modified the definition of business
associates to specifically include several new entities, including subcontractors that create, receive or transmit PHI on behalf of business associates and entities that provide data transmission of PHI
132
Direct Liability for Business Associates and Amendments to Business Associate Agreements
Data storage vendors that maintain PHI (both hardcopy and electronic), are business associates even if the vendor never actually views or accesses the PHI
133
Business Associate Agreements
Business associate agreements will need to be modified to meet additional requirements
The Final Rule provides an extended transition period up to September 22, 2014 for amending existing business associate agreements only for an existing business associate agreement meeting the following conditions:
was in place prior to January 25, 2013 and complies with current HIPAA business associate agreement requirements; and
is not modified or renewed during the period from March 26, 2013 to September 23, 2013
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Business Associate Agreements
Business associate agreements not eligible for the extended transition period must be compliant with the Final Rule as of the September 23, 2013 compliance date
HHS recently issued guidance on the
revised business associate agreement requirements and provided sample terms. This guidance is available at: http://
www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/contractprov.html
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New Fundraising Requirements
Expansion of the type of information covered entities may use to target fundraising appeals to include the department of service, the treating physician and outcome information
Permits the use only of demographic information and dates of health care provided to the patient
Fundraising communications must provide recipients with a clear opportunity to opt-out and the method provided for the opt-out may not cause undue burden or more than nominal costs
136
Decedent information
A covered entity only has an obligation to comply with the requirements of the Privacy Rule with respect to the PHI of a deceased individual for 50 years following the individual’s death
Rule permits covered entities to disclose PHI to a family member or other individual involved in a decedent’s care or payment for such care, unless such a disclosure is inconsistent with a prior expressed preference of the decedent
137
New Enforcement Authority
Enforcement changes effective March 26, 2013
Civil and criminal penalties can now be applied directly to business associates
HHS must investigate any complaint and conduct compliance reviews in all cases where a preliminary review of the facts indicates a possible violation due to willful neglect
HHS must impose a civil money penalty for violations due to willful neglect
138
New Enforcement Authority
HHS is not required to attempt to resolve cases of noncompliance due to willful neglect by informal means
The tiered penalty structure based on different levels of culpability has been finalized. Penalties now range from $100 to $50,000 per violation depending on the level of knowledge/willfulness with a $1.5 million cap per calendar year for multiple violations of identical provisions
139
New Enforcement Authority
Covered entities and business associates can be subject to liability for a violation by their business associate agents and subcontractor business associate agents respectively
HHS may disclose PHI obtained in connection with a compliance review or investigation if permitted under the Privacy Act, thereby giving it the ability to share information with other law enforcement agencies (e.g., state attorneys general or the Federal Trade Commission)
140
Other Important Changes
Expansion of Prohibited Marketing Activities HIPAA prohibits the use or disclosure of PHI for
marketing to individuals without obtaining an authorization, with certain important exceptions
Prohibition on the Sale of PHI Prohibits the receipt of direct or indirect
remuneration (including in-kind benefits) in exchange for PHI
This new restriction includes several exceptions, including disclosures to business associates, as required by law, and for treatment and payment purposes
141
Other Important Changes
New Research Authorizations Permitted allows researchers to obtain authorizations to
use PHI for future research, provided that the future research is adequately described
OIG Compliance Guidance
143
Published in 1999 Still valid today 28 areas of risk Find complete list at:
www.nhpco.org/regulatory/fraud and abuse
143
OIG Identified Risk Areas144
1. Uninformed consent to elect the Medicare Hospice Benefit
2. Admitting patients to hospice care who are not terminally ill. Certification of Terminal Illness 42 CFR § 418.22 Face-to-Face Encounter – 42 C.F.R. § 418.22 (a)(4) “Clinical information and other documentation that
support the medical prognosis must accompany the certification and must be filed in the medical record with the certification.” 418.22(b)(2)
Admission to Hospice 42 C.F.R. § 418.25
3. Arrangement with another health care provider who a hospice knows is submitting claims for services already covered by the Medicare Hospice Benefit
4. Under-utilization
5. Falsified medical records or plans of care.
OIG Identified Risk Areas145
6. Untimely and/or forged physician certifications on plans of care.
7. Inadequate or incomplete services rendered by the Interdisciplinary Group (IDG).
8. Insufficient oversights of patients receiving more than six consecutive months of hospice care.
9. Hospice incentives to actual or potential referral sources (e.g., physicians, nursing homes, hospitals, patients, etc.) that may violate the anti-kickback statute or other similar Federal or State statute or regulation, including improper arrangements with nursing homes.
10. Overlap in the services that a nursing home provides, which results in insufficient care provided by a hospice to nursing home resident
OIG Identified Risk Areas146
11. Improper relinquishment of core services and professional management responsibilities to nursing homes, volunteers, and privately-paid professionals.
12. Providing hospice services in a nursing home before a written agreement has been finalized.
13. Billing for a higher level of services than was necessary.
14. Knowingly billing for inadequate or substandard care.
15. Pressure on a patient to revoke the Medicare Hospice Benefit when the patient is still eligible for and desire care but the care has become too expensive for the hospice to deliver.
OIG Identified Risk Areas147
16. Billing for hospice care provided by unqualified or unlicensed clinical personnel.
17. False dating of amendments to medical records.
18. High-pressure marketing of hospice care to ineligible beneficiaries.
19. Improper patient solicitation activities, such as “patient charting.”
20. Inadequate management and oversight of subcontracted services, which results in improper billing.
21. Sales commissions based upon length of stay in hospice.
OIG Identified Risk Areas148
22. Deficient coordination of volunteers.23. Improper indication of the location where hospice
services were delivered. 24. Failure to comply with applicable requirements for
verbal orders for hospice services.25. Non-response to late hospice referrals by physicians.26. Knowing misuse of provider certification numbers,
which results in improper billing.27. Failure to adhere to hospice licensing requirements
and Medicare conditions of participation.28. Knowing failure to return overpayments made by
Federal health care programs.
FY2013 OIG Work Plan
150
Acute-Care Hospital Inpatient Transfers to Inpatient Hospice Care Review Medicare claims for inpatient stays when
beneficiary was transferred to hospice care and examine the relationship between the acute-care hospital and the hospice provider.
Hospice Marketing Practices and Financial Relationships with Nursing Facilities Review hospices’ marketing materials and practices and
their financial relationships with nursing facilities. Medicare Hospice General Inpatient Care
Use of GIP from 2005 to 2010. Assess appropriateness of GIP claims and beneficiary drug claims billed under Part D.
150
FY2013 OIG Work Plan
151
Medicaid: Hospice Services: Compliance With Reimbursement Requirements We will determine whether Medicaid
payments for hospice services complied with Federal reimbursement requirements.
151
Risk areas for hospice fraud and abuse
153
Eligibility Does this patient meet the eligibility
requirements for admission to the hospice program?
Does the documentation support eligibility? Site of care
Do the patients in nursing facilities meet the eligibility requirements for hospice?
Is the length of stay appropriate, or were those patients admitted “too early” for hospice care?
153
Risk areas for hospice fraud and abuse
154
Level of care Does the level of care match the patient’s
symptom management concerns or family need for respite?
Is General Inpatient care appropriate and documented in the medical record?
Claims submission Are the dates of service, Q-codes for
location of care, and levels of care accurate?
154
Issues Being Audited“Low Hanging Fruit”
• Proper election• Timely certifications
(verbal, written, signed and dated before billing)
• Documentation of verbal certifications
• Brief physician narratives• Face-to-Face (completed
and timely)• Lack of attending physician
for initial certification• Lack of
signatures/stamped signatures
Has signature but no date
Use of continuous care in a skilled nursing facility
Duplicate billing (two providers for same date of service i.e. hospice and hospital)
Physician Billing Medicare Part D
billing
155
More Complex Issues Subject to Audits
156
1. Lack of justification in the record for hospice eligibility
2. Non-Cancer Length of Stay (NCLOS)
3. Length of stay at General Inpatient (GIP) level of care
4. Hospice services provided in the nursing home
5. Lack of justification in the record for level of care provided
Types of Contractors
157
Contractors reviewing hospice claims: (not all-inclusive)
Medicare Medicare Administrative Contractors (MAC) Recovery Audit Contractors (RAC) Zone Program Integrity Contractors (ZPIC) Office of Inspector General (OIG) Department of Justice (DOJ)
Medicaid State Medicaid agency audits Medicaid Integrity Contractors (MIC) Medicaid Recovery Audit Contractors (Medicaid RAC)
157
Medicare RACs158
Three hospice-related issues DME when hospice is involved Physician services when hospice is involved Outpatient hospital services when hospice
is involved First hospice-specific RAC audit
Connolly – automated pull of claims to determine improper or outdated CBSA codes
ZPIC Contractors
159
ZPIC Zone States
Safeguard Services (SGS)
1 California & Nevada
AdvanceMed 2 Washington, Oregon, Idaho, Utah, Arizona, Wyoming, Montana, North Dakota, South Dakota, Nebraska, Kansas, Iowa, Missouri, Alaska
Cahaba Safeguard Services
3 Minnesota, Wisconsin, Illinois, Indiana, Michigan, Ohio, Kentucky
Health Integrity 4 Colorado, New Mexico, Texas and Oklahoma
AdvanceMed 5 Arkansas, Louisiana, Mississippi, Tennessee, Alabama, Georgia, South Carolina, Virginia, West Virginia
Under Protest 6 Pennsylvania, New York, Delaware, Maryland, D.C., New Jersey, Massachusetts, New Hampshire, Vermont, Maine, Rhode Island, Connecticut
Safeguard Services (SGS)
7 Florida
159
Goal of ZPICs
160
The primary goal of ZPICs is to investigate instances of suspected fraud, waste, and abuse.
Conducting investigations in accordance with the priorities established by Center for Program Integrity’s Fraud Prevention System;
Performing medical review, as appropriate;
Referring to law enforcement as appropriate
160
161
Resources for Audits
Front office protocol Mail room protocol Pre-submission billing audit
Available soon at www.nhpco.org/regulatory
Contacts for Reporting Fraud
162
Beneficiaries: Call 1-800-MEDICARE or DHHS OIG hotline at 1-800-HHS-TIPS
(1-800-447-8477)
Providers: Call the DHHS Office of Inspector
General hotline at 1-800-HHS-TIPS (1-800-447-8477).
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164
Federal and State Anti-Kickback Law
Prohibits, among other things, remuneration in return for ordering, or for arranging for or recommending the purchase or order of, any item for which payment may be made in whole or in part under a federal healthcare financing program. 42 U.S.C. 1320a-7B(b).
Comply with federal safe harbor for 25 different business relationships. For example, safe harbors for space rental, personal service and management contracts, equipment rental, referral services, discounts, employees, group purchasing organizations, investment interests, warranties, waiver of beneficiary co-insurance and deductibles, electronic and health records items and services, etc. 42 C.F.R. § 1001.952
165
Federal and State Anti-Kickback Law
Referral Issues: Providing staff, rental payments, meals and
entertainment, training, or back-up staff to referral sources.
Providing payments to entities or individuals to refer patients.
Providing services for free or reduced rate to the patient, or potential patient/family.
Providers agreeing to provide referrals to each other. Aides referring patients in exchange for
hiring/bonus. Aides changing agencies and bringing patients with
them from one agency to another.
166
Problematic Marketing Practices Under Anti-Kickback Law
● “Special Advisory Bulletin Regarding Provision
of Gifts and Other Inducements to Medicare Beneficiaries,” 8/30/02 available at: http://oig.hhs.gov/fraud/docs/alertsandbulletins/sabgiftsandinducements.pdf
● Civil Money Penalties for inducements• “Remuneration”• $10 per item / $50 per year• Five exceptions
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Five Statutory Exceptions
Waivers of cost-sharing amounts based on financial need
Properly disclosed copayment differentials in health plans
Incentives to promote the delivery of certain preventive care services
Any practice permitted under the federal anti-kickback statute pursuant to 42 CFR 1001.952
Waivers of hospital outpatient copayments in excess of the minimum copayment amounts.
168
Problematic Marketing Practices Under Anti-Kickback Law
● Free items or less than fair market value or services contingent on purchases, or on access to referral base
● Payments disguised as grants
● Travel, entertainment, gifts
● Free consultants
● Free CE/CEUs
● Free Transportation
● Courtesy visits to non-hospice patients
● Waiver of cost sharing
169
Anti-Inducement Laws
● ACA § 6402 excludes “certain charitable and other innocuous programs.”a. Remuneration which promotes access to care
and poses a low risk of harm to patients and Federal health care programs;
b. The offer or transfer of items or services for free or less than FMV if:
i. Coupons, rebates, or other rewards from retailer;
ii. Items offered on equal terms to general public regardless of health insurance status; and
iii.Offer or transfer is not tied to provision of care reimbursed by Medicare or Medicaid.
170
Anti-Inducement Laws
c. Offer or transfer of items or services for free or less than FMV by a person to an individual in financial need if not part of an ad or solicitation; not tied to care paid for by Medicare or Medicaid; and there is a reasonable connection between the item or service and the medical care being provided.
d. Effective March 23, 2010
e. Effective January 1, 2011, waiver of certain co-pays under Part D for first prescription under certain circumstances.
171
False Claims Act
• Fraud Enforcement and Recovery Act of 2009 (FERA) – effective May 20, 2009 – amends the FCA.
• False or fraudulent claim for government payment exists regardless of whether the claim was presented to the government for payment.
• Actual knowledge, deliberate ignorance, or reckless disregard used to be intent requirement. Amended to eliminate the intent requirement: “require no proof of specific intent to defraud.”
• Sufficient that the false record or statement may be “material to a false or fraudulent claim.”
• Penalty from $5,500 to $11,000 per claim, plus treble damages.
• Other penalties include criminal prosecution, exclusions, costs and attorneys fees.
• Qui tam provisions – whistleblower
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Return of Overpayments
ACA § 6402 defines overpayment as “any funds that a person receives or retains under Medicare or Medicaid to which the person after applicable reconciliation is not entitled . . .”
Person includes provider of services, Medicaid managed care organization, Medicare Advantage Plan and Prescription Drug Plan.
Report and return the overpayment to Medicare or Medicaid within 60 days after O/P is identified or date any corresponding cost report is due.
173
Return of Overpayments
Failure to return money a provider is not entitled to is considered a violation of the FCA and subjects the provider to a penalty of $5,500-$11,000 per claim
Knowingly concealing or failing to disclose occurrence of event affecting right to payment – 42 U.S.C.1320a-7b(a)(3)
Criminal Sanction
What the Government Expects…175
A provider has a duty to have knowledge of the statutes, regulations and guidelines regarding coverage for Medicare services including but not limited to, the following:
Medicare reimburses only reasonable and necessary medical services furnished to beneficiaries. 42 U.S.C. § 1395y(a)(1)(A)
Providers must assure that they provide economical medical services and then, only when, and to the extent medically necessary. 42 U.S.C. § 1320c-5(a)(1)
What the Government Expects…176
Medicare regulations exclude payment for services that are not reasonable and necessary…. 42 U.S.C. § 411.15(k)
It is a Condition of Participation that hospices must maintain a clinical record for each hospice patient that contains “correct clinical information” All entries in the clinical record must be “legible, clear, complete, and appropriately authenticated and dated…” 42 C.F.R § 418.104
What the Government Expects…
177
A sophisticated hospice provider….is expected to fully know and appreciate the Medicare statute, the definition of “terminally ill” and the local coverage determinations that set out medical criteria for determining whether individuals with certain diagnoses have a prognosis of six months or less to live.
The purpose of the Medicare requirements is to ensure that the limited Medicare funds are properly spent on services actually needed by Medicare beneficiaries. [Hospice] has a duty to deal honestly with the Government. (Recent hospice case)
Compliance plans
178
Vigilance is required about compliance activities Compliance with:
Medicare Hospice Conditions of Participation Other hospice regulations Claims submission requirements Eligibility requirements Requirements for continued eligibility
Compliance plan should include: Specific timeframes for internal audits of agency
practices Protocol for reviewing processes that may be out of
compliance with current laws and regulations.
178
Compliance Programs for Hospices
180
Seven Elements:1. Written Policies, procedures and standards
of conduct
2. Compliance officer and compliance committee
3. Effective training and education
4. Develop effective lines of communication
5. Enforce standards through well publicized disciplinary guidelines
6. Conduct internal auditing and monitoring
7. Respond promptly to detected offenses and develop corrective actions
#1: Written Policies, Procedures and Standards of Conduct
181
Code of Business Ethics and Conduct: Commitment to full compliance with all Federal and State
health care program requirements. Expectation that all associates will comply with these
requirements. Report suspected violations of any Federal/State law or
regulation or company’s policies to the Compliance Officer, or other appropriate individual.
Report concerns through the Company Compliance Officer Commitment to non-retaliation against employees who
disclose compliance concerns. Maintain, as appropriate, the confidentiality and
anonymity of these employees, with respect to such disclosures
#1: Written Policies, Procedures and Standards of Conduct
182
Written Policies and Procedures: Comprehensive and comprehensible Distributed /available to all employees Frequently updated
Risk Areas: Should be addressed in written policies OIG identified 28 risk areas –
(OEI-04-93-00270 – Medicare Hospice Beneficiaries: Services and Eligibility)
Still relevant today especially : Eligibility, Consent, Anti-Kickback
#1: Written Policies, Procedures and Standards of Conduct183
Records and Documentation: Medical Record and Billing Process/Records Compliance Program Documentation:
Training, Hotline calls, corrective action plans, self-disclosures, audit and monitoring results, program modifications
Compliance as an Element of a Performance Plan
#2: Compliance Officer and Compliance Committee
184
Compliance Officer:
Integrity, Independence, Authority
• Oversee/monitor the compliance program• Reports to Governing Body, Board of Directors, CEO
and Compliance Committee• Revises Program r/t regulatory, and/or statutory
changes• Develops and participates in training• Independent Contractors• OIG/GSA checks• Investigations
#2: Compliance Officer and Compliance Committee
185
Compliance Committee:• Senior management, drawn form all
departments• Assist and support the compliance officer• Analyze and review legal requirements• Review/revise existing policy• Determine strategy• Monitor internal and external reviews
#3: Effective Training and Education
186
• All Staff: corporate officers, senior management, volunteers, nurses, physicians, other clinical staff, administrative, marketing and financial services.
• Annual, mandatory, post-tests and employee attestations
• Business Ethics and Compliance• HIPAA• Features of the Medicare Hospice
Benefit
#3: Effective Training and Education
187
• Election, eligibility and consents• Regulations, statutes and COPs
related to Medicare Program Integrity
• Patient rights• Duty to comply and report
misconduct• Marketing
#4: Develop Effective Lines of Communication
188
Access to the Compliance Officer Unfettered access to the compliance
officer Non-retaliation Confidential and anonymous (some
caveats here)
#4: Develop Effective Lines of Communication
189
Hotline and Other forms of Communication Confidential Hotline
Confidential and anonymous Readily available Distributed to all Appropriate follow-up to calls: log,
investigations, reports E-mail, suggestion box, newsletters etc.
can also be used
#5: Enforce Standards Through Well Publicized Disciplinary Guidelines
190
Effective Disciplinary Policies and Actions Well disseminated Effective Fair and equitable Enforced
New Employee Policies Background checks OIG/GSA Exclusion Lists State Medicaid exclusion lists
#6: Auditing and Monitoring191
Pre-bill Audits Internal Review Admission Audits Certification Audits Recertification Audits Investigation of Hotline calls and other
complaints Patient/family complaints Collate data – review trends – provide
feedback Act on findings – education, plan of
correction, discipline
192
Provider Self Audits
Publication 100-08 1.3.9 – Provider Self Audits (Rev. 425, Issued: 06-15-12, Effective: 07-16-12, Implementation;
07-16-12)
Providers may conduct self-audits to identify coverage and coding errors. The Office of Inspector General (OIG) Compliance Program Guidelines can be found at http://oig.hhs.gov/compliance/compliance-guidelines/index.asp and the statistical guidelines in http://oig.hhs.gov/authorities/docs/selfdisclosure.pdf (if statistical sampling is utilized during the audit). ACs and MACs shall follow chapter 4, section 4.16, handling any voluntary refunds that may result from these provider self-audits.
Most errors do not represent fraud. Most errors are not acts that were committed knowingly, willfully, and intentionally.
However, in situations where a provider has repeatedly submitted claims in error, the ACs and MACs shall follow the procedures listed in chapter 3, section 3.2.1. For example, some errors will be the result of provider misunderstanding or failure to pay adequate attention to Medicare policy. Other errors will represent calculated plans to knowingly acquire unwarranted payment. Per chapter 4, section 4.2.1, ACs and MACs shall take action commensurate with errors made. ACs and MACs shall evaluate the circumstances surrounding the errors and proceed with the appropriate plan of correction.
#7: Respond to Detected Offenses and Develop Corrective Action initiatives
193
Failure to respond to/correct detected potential violations can seriously endanger the mission, reputation and legal status of the hospice. “…..disregarded concerns expressed by its staff and
auditor that the organization was admitting and retaining patients who were not eligible for Medicare hospice benefits.”
“In spite of these warnings and red flags…it has provided no information or documentation to show that it made changes to its business practices or took corrective actions. It did not contact Medicare officials to request guidance or to report errors or overpayments of Medicare dollars”
#7: Respond to Detected Offenses and Develop Corrective Action initiatives
194
Report misconduct within a reasonable period Demonstrates good faith Failure to do so might be construed as a
deliberate attempt to conceal findings from the Govt.
Provide evidence of the violation and estimate of the overpayment that resulted from it.
Return the overpayment (See return of overpayments)
Demand plan of correction Implement corrections to practices and required
disciplinary action Evaluate effectiveness of corrective actions
196
Q&A
NHPCO members enjoy unlimited access to Regulatory Assistance
Feel free to email questions to [email protected]
197
Regulatory and Compliance Team at NHPCO
Jennifer Kennedy, MA, BSN, RNRegulatory and Compliance Director
Judi Lund Person, MPHVice President, Compliance and
Regulatory Leadership
Email us at: [email protected]