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HOT REGULATORY
TOPICS
JUDI LUND PERSON, MPH
NHPCO
1
2
Eligibility
Eligibility for Admission
Medicare Hospice Benefit
3
§ 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.
Compliance “Hot Spots”
4

Eligibility of hospice patients
Initial
 Ongoing
 Physician narrative


Certain non-cancer diagnosis
Dementia/ Alzheimer's
 Debility unspecified


Level of care documentation

GIP
MAC Compliance “Hot Spots”
5

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
Opportunities to document eligibility
6

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

Eligibility assessment
7
Definitely
eligible
Probably
eligible
Not eligible
Eligibility - 1st 90-day period
8

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
Eligibility - 1st 90-day period
9

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
Eligibility – Continued and at
Recertification
10

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/ Recertification
11
NHPCO Certification/ recertification Process Maps
available for purchase in NHPCO’s Marketplace
Co-morbidities
12
Although not the primary hospice diagnosis, the
presence of disease such as the following…should be
considered in determining hospice eligibility

Chronic obstructive pulmonary
disease

Congestive heart failure

Ischemic heart disease

Diabetes mellitus

Neurologic disease (CVA, ALS,
MS, Parkinson’s)
•
•
•
•
Renal failure
Liver Disease
Neoplasia
Acquired immune deficiency
syndrome
• Dementia
Local Coverage Determination Policies (LCDs)
13
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)
14


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
15

Documentation needs to address:
 Impairments in function & structure
 Activity limitations
 Participation restrictions
 Secondary diagnoses
 Co-morbid conditions
Documentation Using LCDs
16



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
67
Documentation Using LCDs
17




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
The physician narrative
18

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
 Reference
to specific LCDs as appropriate
to prognostic indicators or symptom
management sales as appropriate
The physician narrative
19

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
The physician narrative
20

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
21
Quality Reporting
CY2013 QUALITY REPORTING
22
Measures for quality reporting:


NQF #0209 Pain Measure
Structural Measure
CY2013 QUALITY REPORTING
23
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.
CY2013 QUALITY REPORTING
24
Structural Measure:
Participation in a QAPI program that includes at
least 3 quality indicators related to patient care
CY2013 QUALITY REPORTING
25
QAPI Structural Measure
Submission =
 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.
CY2013 QUALITY REPORTING
26
QAPI Structural Measure
No results are submitted -- only the patient care
measure descriptions
Hospice Quality Reporting
27




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
Miss the deadlines?
28
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
29
CMS Hospice Quality Reporting web page
Information posted on CMS web site as it becomes
available
https://www.cms.gov/Medicare/Quality-InitiativesPatient-Assessment-Instruments/Hospice-QualityReporting/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.
NHPCO RESOURCES
30
Basic Information and Materials

www.nhpco.org/outcomemeasures

www.nhpco.org/qualityreporting
Questions – send email to:

[email protected]
31
THE FUTURE OF HOSPICE QUALITY REPORTING
Payment Year FY2015
32


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.
Data Collection Period
33



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.
Payment Year FY2015
34


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
Patient level data collection
35



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
STANDARDIZED DATA ITEM SET
36
CMS developing standardized assessment instrument





Many items standardized and used by other providers
Some items developed specifically for hospice
Developed to collect information for hospiceappropriate quality measures
Pilot testing with 9 hospices summer/fall 2012
Propose to implement hospice patient-level data item
set as early as CY 2014
Payment Determinations beyond FY2015
37

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
Experience of Care Survey
38


Similar to FEHC
CAHPS survey being developed now
VALUE BASED PURCHASING
39

Value based purchasing – pilot testing


Utilize already implemented measures
Implement pilot by January 1, 2016
40
Part D and Hospice
Part D and Hospice
41



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
Recent Analysis
42


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….
Recent Analysis
43

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
CMS Draft 2014 Call Letter
44



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
45
Multiple Diagnoses on Claim Form
Multiple diagnoses on claim form
46


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
Multiple diagnoses on claim form
47

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 ICD9-CM Coding Guidelines” (IOM 100-04, chapter 11, section
30.1, available at http://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/Downloads/clm104c11.pdf)
Multiple diagnoses on claim form
48

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
Mixed messages from CMS
49



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

The issues
50

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
Corollary issues
51

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…..
Joint task force – NHPCO & NAHC
52

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
53
Illegal Aliens
Provider responsibility
54



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
55
2013 PEPPER report
PEPPER Report
56




The Program for Evaluating Payment Patterns
Electronic Report (PEPPER) second report
Available April 2013
FedEx to the hospice CEO
Hospice-specific data statistics
PEPPER Details
57





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

PEPPER Details
58


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
PEPPER Details
59




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
Focus of PEPPER Report
60


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
PEPPER Resources
61

www.pepperresources.org
62
HIPAA Omnibus Rule
The final omnibus rule
63

The final omnibus rule was published in the January
17, 2013 Federal Register



http://www.gpo.gov/fdsys/pkg/FR-2013-0125/pdf/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
When is compliance required?
64


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
New rule
65


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
New Breach Standard
66


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
New Breach Standard
67


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
New Breach Standard
68

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
Expanded Individual Rights
69

Individuals’ rights expanded with respect to their PHI
in two important ways
1.
2.

It provides them with the right to receive certain PHI
electronically
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
Expanded Individual Rights
70



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
Expanded Individual Rights
71


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
Modifications to Notices of Privacy
Practices Required
72


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
Direct Liability for Business Associates and
Amendments to Business Associate Agreements
73

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
Direct Liability for Business Associates and
Amendments to Business Associate Agreements
74

Data storage vendors that maintain PHI (both
hardcopy and electronic), are business associates even
if the vendor never actually views or accesses the PHI
Business Associate Agreements
75


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
Business Associate Agreements
76


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/cove
redentities/contractprov.html
New Fundraising Requirements
77



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
Decedent information
78


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
New Enforcement Authority
79




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
New Enforcement Authority
80


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
New Enforcement Authority
81


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)
Other Important Changes
82

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

Other Important Changes
83

New Research Authorizations Permitted

allows researchers to obtain authorizations to use PHI for
future research, provided that the future research is
adequately described
84
84
FY 2013 OIG Work Plan
FY2013 OIG Work Plan
85

Acute-Care Hospital Inpatient Transfers to Inpatient
Hospice Care


Hospice Marketing Practices and Financial
Relationships with Nursing Facilities


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.
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.
85
FY2013 OIG Work Plan
86

Medicaid: Hospice Services: Compliance With
Reimbursement Requirements
 We
will determine whether Medicaid payments for
hospice services complied with Federal reimbursement
requirements.
86
Regulatory and Compliance Team
at NHPCO
87
Jennifer Kennedy, MA, BSN, RN
Regulatory and Compliance Director
Judi Lund Person, MPH
Vice President, Compliance and Regulatory
Leadership
Email us at: [email protected]
Q&A
NHPCO members enjoy unlimited access to Regulatory Assistance
Feel free to email questions to [email protected]

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