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Top Five Compliance Topics for
Independent Owners
CAHF Independent Owners Symposium, May 1-2, 2012
Mark A. Johnson
101 W. Broadway
Suite 1200
San Diego, CA 92101
(619) 744-7300
Mark E. Reagan
575 Market St.
Suite 2300
San Francisco, CA 94105
(415) 875-8500
[email protected]
[email protected]
Hooper, Lundy & Bookman, Inc.©
OVERVIEW
1.
2.
3.
4.
5.
2
Hospital Readmissions
Vendor and Referral Relationships – “Fair
Market Value”
Excluded Individuals – OIG/GSA/CA
3.2 NHPPD – Documentation
Informed Consent – verification for
psychotherapeutic medication.
Hooper, Lundy & Bookman, Inc.©
Hospital Readmissions
Single biggest issue now and in the foreseeable
future
3
Enormous amounts of resources
Payors see huge savings
Hooper, Lundy & Bookman, Inc.©
Hospital Readmissions
Reimbursement, compliance and business issues
Federal programs implicated
4
Relationships with: hospitals, physicians, health plans
and regulators
Hospital IPPS rule – readmission penalties beginning
October 1, 2012
CMS Dual-Eligibles demonstration project – beginning
as early as January 1, 2013
Hooper, Lundy & Bookman, Inc.©
Hospital Readmissions
Federal programs implicated
Intersection with State programs
5
Accountable Care Organizations/Shared Savings
Programs – beginning early to mid-2013
Bundling pilots
Coordinated Care Initiative – beginning as early as
January 1, 2013
Dual-Eligibles demonstration project – 1/1/2013
Hooper, Lundy & Bookman, Inc.©
Hospital Readmissions
California Readmission Goals
Q4 2010 to Q1 2011 Readmissions Data
3,429,614 total Medicare FFS beneficiaries
403,880 (12%) were discharged
78,397 (19.4%) were readmitted within 30 days
California's Goal:
Reduce overall readmission rate by 20 percent
Prevent 15,000 avoidable readmissions
(Source: HSAG-California, the Medicare QIO for
California)
6
Hooper, Lundy & Bookman, Inc.©
Hospital Readmissions
Financial Impact
Average readmission costs $8,000-$13,000
x
California prevents 15,000 readmissions
=
$120 - $195 million saved
(Source: HSAG-California)
7
Hooper, Lundy & Bookman, Inc.©
Medicare FFS Readmission Data
2010Q4-2011Q1 (Source: HSAG-California)
Setting
Discharged
To
Home
Nursing Home
Home Health
Hospice
8
Other
All
# of
discharges
# of
readmitted
Discharges
within 30
days
30-day
Readmit
Rate
30-day
readmit
rate
(to same
hospital)
30-day
readmit
rate
(to another
hospital)
210,568
36,973
17.6%
72.6%
27.4%
92,286
21,497
23.3%
73.7%
26.3%
64,575
13,453
20.8%
77.4%
22.6%
7,973
289
3.6%
64.7%
35.3%
28,478
6,185
21.7%
58.4%
41.6%
403,880
78,397
19.4%
72.6%
27.4%
Hooper, Lundy & Bookman, Inc.©
Percentage of Medicare FFS
Patients Readmitted within…
(Source: HSAG-California)
9
Hooper, Lundy & Bookman, Inc.©
Hospital Readmissions
Common Drivers
Lack of standard discharge processes
Lack of engagement or activation of patients and families
Patients call 911 or return to emergency departments instead of
accessing a different type of medical service
Ineffective or unreliable sharing of relevant clinical
information
Patients did not understand/did not correctly take medications
(Source: HSAG-California)
10
Hooper, Lundy & Bookman, Inc.©
Hospital Readmissions
Near term – October 1, 2012
Acute hospital impacts
Adverse financial impacts
Actual performance verses benchmarks
11
Acuity and demographics taken into account
Limited at first to heart failure, pneumonia and
myocardial infarction
Limited to 30 days post-discharge
Hooper, Lundy & Bookman, Inc.©
Hospital Readmissions
Impact on referral patterns
12
Facility history of readmissions
Facility commitment to change
Participation in readmission reduction programs (e.g.,
Interact II, COMS, etc.)
Hooper, Lundy & Bookman, Inc.©
Hospital Readmissions
Mid-Term impacts
CCI/Dual-Eligibles demonstration
ACOs and Bundling Pilots
Similar impacts on referral patterns
13
Health plans, physician groups, acute hospitals
Hooper, Lundy & Bookman, Inc.©
Hospital Readmissions
Long term impacts
Direct impact on SNFs
President’s budget
AHCA policy
14
Hooper, Lundy & Bookman, Inc.©
Vendor and Referral Relationships
Health Care Fraud Focus Area: Anti-Kickback Statute
Current Enforcement Environment
FCA Implications
Company/Facility Strategies –
15
Swaps
Referrals
Discounts
Compliance Programs/Training
Marketing – Value Based Purchasing
Hooper, Lundy & Bookman, Inc.©
Vendor and Referral Relationships
Federal Anti-Kickback Statute is a criminal
statute that prohibits payments as inducement for
referrals of patients for services paid for by
Federal health care programs
16
Key terms: criminal, payment or remuneration,
inducement, referral
Both sides of transaction have liability
Hooper, Lundy & Bookman, Inc.©
Vendor and Referral Relationships
Federal Anti-Kickback Statute – including
addressing free goods and services, marketing
arrangements, financial arrangements with
physicians and other sources of referrals
17
Prohibition against remuneration (in any form, whether
direct or indirect) made purposefully to induce or
reward the referral or generation of Federal health care
program business
Hooper, Lundy & Bookman, Inc.©
Federal Anti-Kickback Statute
18
Referral sources – physicians, other health care
professionals, hospitals and hospital discharge
planners, hospices, home health agencies and
nursing facilities
SNFs refer to – physicians, hospices, DME,
laboratories, pharmacies, hospitals, therapy
companies, dentists, and nursing facilities
Hooper, Lundy & Bookman, Inc.©
Federal Anti-Kickback Statute
Payment or Remuneration – any type of cash or
in-kind benefit that can be assigned a monetary
value
19
Long-term credit arrangements
Discounts
Rebates
Supplies, equipment, space
Gift cards, lunches, meals?
Hooper, Lundy & Bookman, Inc.©
Federal Anti-Kickback Statute
No “de minimis” exception
Only exists for Stark Law
Stark Law regulations – Nonmonetary compensation.
(1) Compensation from an entity in the form of items
or services (not including cash or cash equivalents) that
does not exceed an aggregate of $300 per calendar
year, as adjusted for inflation
Not related to volume/value of referrals
Not solicited by referral source
20
Hooper, Lundy & Bookman, Inc.©
False Claims Act Implications
PPACA or Health Care Reform amended the AntiKickback Statute to provide that any claim that
“result[s] from” an AKS violation is now a false
or fraudulent claim under the FCA
21
Any AKS violation self-disclosure should result in an
overpayment evaluation
60-day rule
Hooper, Lundy & Bookman, Inc.©
Federal Anti-Kickback Statute
Focus areas for OIG re: Anti-Kickback Statute
22
Free goods and services
Swapping
Discounts
Services contracts
Hooper, Lundy & Bookman, Inc.©
Federal Anti-Kickback
Free Goods and Services
Dental Providers
Free check-ups for SNF employees
Free replacement of dentures
Pharmacy
Hospice
23
Free consultant services
Nursing services for patients other than hospice
Hooper, Lundy & Bookman, Inc.©
Swapping Arrangements
Ambulance provider – SNF accepts a low price
from ambulance provider on Part A transfers in
exchange for referring the Part B transfers
24
Ambulance bills SNF for Part A transfers - $200
Ambulance bills Medicare for Part B transfers - $400
OIG – “Arrangements prone to swapping
problems are those with ambulance providers,
clinical laboratories and DME suppliers”
Hooper, Lundy & Bookman, Inc.©
Discounts
Discount safe harbor – 42 C.F.R. § 1001.952(h)
One of the most complex and most utilized
For Cost-Reimbursed Buyers
Discount must be earned based on purchases of that same
good or service bought within single fiscal year of the buyer
Buyer must claim the benefit of the discount within that fiscal
year or the following year
Buyer must fully and accurately report the discount on the
applicable cost report
Upon request, Buyer must disclose information from Seller
regarding compliance
25
Hooper, Lundy & Bookman, Inc.©
Discounts
Discounts – A reduction in the amount a buyer is
charged for an item or service based on an armslength transaction
42 C.F.R. § 1001.952(h)(5) – Does not include:
Cash payments or cash equivalents (except rebates, as
defined)
Supplying one good or service at a reduced charge to induce
the purchase of a different good or service, unless both are
reimbursed by a Federal program using same methodology
and fully disclosed and reported
A reduction in price applicable to one payor but not to
Medicare/Medicaid or other Federal programs
26
Hooper, Lundy & Bookman, Inc.©
Discounts
42 C.F.R. § 1001.952(h)(5) – Does not include:
27
A routine reduction or waiver of any coinsurance or
deductible amount owed by a program beneficiary
Warranties
Services provided in accordance with a personal or
management services contract
Hooper, Lundy & Bookman, Inc.©
Vendor Strategies
28
Point person for negotiations
Discussion of policies and procedures
Form contracts developed by legal counsel
Other reasons for selecting vendor – quality,
consistency, reputation, efficiency
Hooper, Lundy & Bookman, Inc.©
Services Contracts
Services contracts
To minimize the risk of disguised kickbacks in physician and nonphysician services contracts, a facility should periodically review
arrangement to ensure:
29
A legitimate need for services or supplies
Services or supplies were actually provided and adequately
documented
Fair market value compensation
Arrangement not related in any manner to the volume of federal
healthcare program business
Hooper, Lundy & Bookman, Inc.©
Current Enforcement Environment
Multiple active investigations throughout
California and nationwide
30
Ambulance providers
Physician relationships
Referral companies
SNF – Hospital relationships
Hospices
Home Health Agencies
Hooper, Lundy & Bookman, Inc.©
Compliance Program
31
OIG Compliance Guidance for Nursing Homes,
issued March 2000, available at:
http://oig.hhs.gov/authorities/docs/cpgnf.pdf
OIG Supplemental Compliance Guidance for
Nursing Homes, issued Sept. 2008, available at:
http://oig.hhs.gov/fraud/docs/complianceguidance
/nhg_fr.pdf
Hooper, Lundy & Bookman, Inc.©
Compliance Program
Auditing
Self-audit of elements of program, such as billing
and/or quality of care issues
Effectiveness – When issues are identified through
auditing, does the compliance program address the
issues?
Does the compliance committee meet to review?
Employee training?
32
Updating of the program by compliance officer
Hooper, Lundy & Bookman, Inc.©
Compliance Program
Elements of Effective Compliance Program
33
Implementing written policies, procedures and standards of
conduct
Designating a compliance officer and compliance committee
Conducting effective training and education
Developing effective lines of communication
Conducting internal monitoring and auditing
Responding promptly to detected offenses and developing
corrective action
Hooper, Lundy & Bookman, Inc.©
Marketing Strategies
Think Value Based Purchasing
34
New Metrics
Best Practices
Performance Based
Information Technology
Coordination of Care
Marketing activities to referral sources should be
focused on these elements
Hooper, Lundy & Bookman, Inc.©
Excluded Individuals
Employee screening – including appropriate screening
for excluded individuals
No Federal health care program payment may be made for
items or services furnished by an excluded individual or entity
Screen all owners, directors, officers, employees, and
contractors (temporary staffing)
35
Where to screen – OIG, GSA, Medi-Cal
How often? Yearly, semi-annual, monthly?
What do you do if you identify an excluded individual?
Hooper, Lundy & Bookman, Inc.©
Excluded Individuals
Where to check:
OIG List of Excluded Individuals and Entities
http://exclusions.oig.hhs.gov/
GSA Excluded Parties List System
https://www.epls.gov/
Multiple search options
DHCS/Medi-Cal Suspended and Ineligible
Provider List
36
“Google” it
Hooper, Lundy & Bookman, Inc.©
Excluded Individuals
How often? Yearly, semi-annual, monthly?
No less than yearly. OIG would prefer semi-annual or more
often
Records – Maintain the records of background checks.
What do you do if you identify an excluded individual?
Self-disclosure
Is there an overpayment?
Is there a penalty?
37
Hooper, Lundy & Bookman, Inc.©
3.2 NHPPD – Documentation
Environment
38
Audits began in February 2011
Results started getting issued in February 2012
DPH has centralized the review in Sacramento
Inconsistencies at the facility level
Lack of training/experience/understanding by some
surveyors
Hooper, Lundy & Bookman, Inc.©
3.2 NHPPD – Documentation
Audit
The auditor will provide the facility with a list of 24
random dates from the prior 90 day period and ask for
date-specific documentation:
Census and Nursing Hours Per Patient Day (CDPH 612) or
alternative form
Payroll records, nursing payroll codes, time cards
Nursing Staffing Assignment and Sign-In Sheet (CDPH 530)
or alternative form
39
Hooper, Lundy & Bookman, Inc.©
3.2 NHPPD – Documentation
“PRM” Documentation Requirements
40
Duty statements, job descriptions
Registry invoices
If applicable: records submitted to CMS, Medi-Cal, or
insurance companies for purposes of remibursement
Contract with NATCEP vendor
Facility Personnel Records in compliance with 9-10 of
AFL
Hooper, Lundy & Bookman, Inc.©
3.2 NHPPD – Documentation
Audit
41
All required documentation must be provided ONSITE
Plan ahead for obtaining centralized payroll and other
documents
Electronic payroll records for the dates under review
must also be printed and provided.
Hooper, Lundy & Bookman, Inc.©
3.2 NHPPD – Documentation
For employees with nursing and non-nursing functions:
Clearly document time spent performing nursing AND nonnursing functions
Utilize staffing assignment and sign-in sheet with prescribed fields
or CDPH form 530
CDPH 530 ONLY utilized to:
Document nursing services provided by nursing staff NOT captured in
payroll records; and
Nursing serivces provided by nursing staff primarily engaged in duties
other than nursing services
42
Hooper, Lundy & Bookman, Inc.©
3.2 NHPPD – Documentation
Staffing Assignment Attestation
43
Each nursing staff assignment and sign-in sheet must
be signed by the DON or designee and verify that:
1. All staffing assignments are reviewed and verified
as true and accurate;
2. All direct caregivers providing nursing services
during the patient day are recorded; and
3. All NHPPD are accounted for with an original
signature
Hooper, Lundy & Bookman, Inc.©
3.2 NHPPD – Documentation
Meal periods deducted from total nursing hours
for the timeframes identified on the “assignment
sheet”
*Meal periods NOT identified will be deducted as
follows:
44
30 minutes for every 6 hours worked
1 hour for every 10 hours worked
*Unless documentation provided that services
provided in lieu of a meal break
Hooper, Lundy & Bookman, Inc.©
3.2 NHPPD – Documentation
Meal periods
45
For 10 hours or more of continuous time worked where
only 30 minutes of meal time was taken and 30
minutes of meal time was paid, facility must provide
documentation that the employee opted to be paid in
lieu of the second 30 minute meal break
Hooper, Lundy & Bookman, Inc.©
3.2 NHPPD – Documentation
Census Attestation Statement
Each 24 hour census must include an attestation signed
by the DON or designee verifying that:
The patient census and nursing hours documentation has been
reviewed; and
The information is true and correct.
46
Hooper, Lundy & Bookman, Inc.©
Informed Consent for
Psychotherapeutic Drugs
47
Recently, there has been a focus on whether
patients in SNFs who are receiving
psychotherapeutic drugs actually give informed
consent to the treatment.
Patients have a right to be free from
psychotherapeutic drugs and physical restraints
used for the purpose of patient discipline or
staff convenience and to be free from
psychotherapeutic drugs used as a chemical
restraint. (Title 22, Section 72527(a).)
Hooper, Lundy & Bookman, Inc.©
Informed Consent for
Psychotherapeutic Drugs
Title 22, Section 72528 states that the information that
is material to a patient’s decision concerning the
administration of a psychotherapeutic drug (or physical
restraint) shall include:
48
The reason for the treatment and the nature and seriousness
of the patient’s illness.
The nature of the procedures to be used in the proposed
treatment including their probable frequency and duration.
The probable degree and duration (temporary or
permanent) of improvement or remission, expected with or
without treatment.
Hooper, Lundy & Bookman, Inc.©
Informed Consent for
Psychotherapeutic Drugs
Title 22, Section 72528 (cont’d):
49
The nature, degree, duration and probability of the side
effects and significant risks, commonly known by the health
professions.
The reasonable alternative treatments and risks, and why the
health professional is recommending this particular
treatment.
That the patient has the right to accept or refuse the
proposed treatment, and if he or she consents, has the right
to revoke his or her consent for any reason at any time.
Hooper, Lundy & Bookman, Inc.©
Informed Consent for
Psychotherapeutic Drugs
50
Importantly, Title 22, Section 72528 requires
that before initiating the administration of
psychotherapeutic drugs (or physical
restraint) facility staff shall verify that the
patient’s health record contains
documentation that the patient has given
informed consent to the proposed treatment
or procedure.
Title 22 also includes an exception for emergency treatment –
where there is an unanticipated condition in which immediate
action is necessary for preservation of life or the prevention of
serious bodily harm to the patient or others.
Hooper, Lundy & Bookman, Inc.©
DPH All Facilities Letter
January 7, 2011
Changes to DPH Interpretation
of Section 72528(c)
51
Hooper, Lundy & Bookman, Inc.©
DPH AFL January 7, 2011 –
Informed Consent
52
52
Previously found that unchanged, pre-existing
orders for psychotherapeutic drugs/physical
restraints or prolonged use of certain devices did
not require verification of informed consent in
medical records
DPH now requires verification present in medical
records in AFL 11-08
Hooper, Lundy & Bookman, Inc.©
DPH AFL January 7, 2011 –
Informed Consent
DPH issues comprehensive Q&A in AFL 11-31
(April 12, 2011)
Significant Issues
53
AFL 11-08 requirement of documenting verification of
informed consent
No “delegation” of informed consent from M.D. to
facility staff permitted
Phone informed consent acceptable
Facility policies and procedures need to reflect how
verification to be obtained
Hooper, Lundy & Bookman, Inc.©
DPH All Facilities Letter
June 4, 2009
Informed Consent
for Antipsychotic Medication
54
Hooper, Lundy & Bookman, Inc.©
DPH AFL June 4, 2009 – Informed Consent
55
The AFL discusses the provisions of current
law regarding informed consent for
prescribing antipsychotic medication
pursuant to Health & Safety Code 1418.9.
The H&S Code section referenced above
pertains to residents who have the capacity
to offer consent.
If a resident does not have the capacity, then
a designated family member may offer
consent. A physician makes the
determination on whether capacity exists.
Hooper, Lundy & Bookman, Inc.©
DPH AFL June 4, 2009 – Informed Consent
If the attending physician of a resident in a
SNF prescribes, orders, or increases an
order for an antipsychotic medication for
the resident, the physician shall do the
following:
56
Obtain informed consent of the resident for
purposes of prescribing, ordering, or increasing
an order for the medication;
Seek the consent of the resident to notify the
resident’s interested family member, as
designated in the medical record.
Hooper, Lundy & Bookman, Inc.©
DPH AFL June 4, 2009 – Informed Consent
57
If the resident consents to
notifying the interested family
member, the physician shall make
reasonable attempts, either
personally or through a designee,
to notify that family member
within 48 hours of the
prescription, order, or increase of
an order.
Hooper, Lundy & Bookman, Inc.©
Notification
DPH AFL June 4, 2009 – Informed Consent
Notification of an interested family member is not
required if any of the following circumstances
exist:
58
There is no interested family member designated in the
medical record;
The resident has been diagnosed as terminally ill by his
physician and is receiving hospice services from a
licensed, certified hospice agency in the facility;
The resident has not consented to the notification.
Hooper, Lundy & Bookman, Inc.©
DPH AFL June 4, 2009 – Informed Consent
59
The AFL reiterates that the law does not require
the attending physician to obtain consent from an
interested family member in order to prescribe,
order, or increase an order for antipsychotic
medication.
Hooper, Lundy & Bookman, Inc.©
Questions?
60
Top Five Compliance Topics for
Independent Owners
CAHF Independent Owners Symposium, May 1-2, 2012
Mark A. Johnson
101 W. Broadway
Suite 1200
San Diego, CA 92101
(619) 744-7300
Mark E. Reagan
575 Market St.
Suite 2300
San Francisco, CA 94105
(415) 875-8500
[email protected]
[email protected]