Transcript Slide 1
Changes to Medicare’s
Conditions for Coverage
ASCs 2009
Nashville, TN
Dawn Q. McLane RN, MSA, CASC, CNOR
Lakeshore Surgicare (NRG Managed) – Administrator
Jonathan Beal –ASC Association
Overview of Changes
Conditions for Coverage (CfC) = the requirements that ASCs
have to meet to participate in Medicare (CFR sec. 416)
Must meet requirements for all patients not just Medicare
patients
Changes finalized November 18, 2008 (73 FR 68502 et. seq.)
Effective date: May 18, 2009
Currently 10 Conditions with 16 Standards
New: 13 Conditions with 35 Standards
Interpretive guidelines
www.ascassociation.org/cfcredline.pdf - redlined version
of the CfC
Summary of Changes
Conditions
Standard
Change?
State Law
No Change
Governing Body and Management
Contract Services
Hospitalization
Disaster Preparedness Plan
Revised
Surgical Services
Anesthetic Risk and Evaluation
Administration of Anesthetic
State Exemption
Revised
Quality Assessment and Improvement
Program Scope
Program Data
Program Activities
Performance Improvement Projects
Governing Body Requirements
Revised
Summary of Changes Continued…
Environment
Physical Environment
Safety from Fire
Emergency Equipment
Emergency Personnel
No Change
Medical Staff
Membership and Clinical
Reappraisals
Other practitioners
No Change
Nursing Services
Organization and Staff
No Change
Medical Records
Organization
Form and Content
No Change
Pharmaceutical Services
Administration of Drugs
No Change
Summary of Changes Continued…
Laboratory and Radiologic Services
Laboratory Services
Radiologic Services
Revised
Patient Rights
Notice of Rights
Advance Directives
Submission and Investigation of Grievences
Exercise of Rights and Respect for Property and Person
Privacy and Safety
Confidentially of Clinical Records
New
Infection Control
Sanitary Environment
Infection Control Program
New
Patient Admission, Assessment and Discharge
Admission and Pre-Surgical Assessment
Post- Surgical Discharge
Discharge
New
Change in Definition of an ASC
a distinct entity that operates exclusively
for the purpose of providing surgical
services to patients not requiring
hospitalization
the expected duration of services would
not exceed 24 hours following admission
must have agreement with CMS and meet
the CfC
Governing Body and Management
responsible for policies governing
operations
Oversight and accountability for QAPI
program
Develops and maintains disaster
preparedness plan
ASC has transfer agreement with CMS
hospital or physicians performing surgery
have admitting privileges at hospital (that
meets CMS requirements)
Governing Body and Management
Disaster preparedness plan
written plan
provides for emergency care of patients,
staff and others in the facility in the event of
fire, natural disaster, functional failure of
equipment or other unexpected events that
would threaten the health and safety of those
in the ASC
coordinates the plan with state and local
authorities, as appropriate
conducts drills at least annually & completes
written evaluation of drill, promptly
implementing corrections
Quality Improvement
Develop, implement, and maintain
an ongoing, data-driven QAPI program
Standard - Scope:
demonstrates measurable improvement in patient
outcomes
improves patient safety – use of quality indicators,
performance measures or reduced medical errors
measure, analyze and track quality indicators, adverse
patient events, infection control and other aspects of
care
Standard - Data:
must incorporate data to:
monitor the effectiveness of services and quality of care
identify areas for improvement and changes in patient
care
Quality Improvement
Standard - Program Activities: Set priorities
for PI activities
focus on high risk, high volume, and problem-
prone areas
consider incidence, prevalence and severity of
problems
affect health outcomes, patient safety and
quality of care
track adverse pt events, examine cause,
implement improvement and ensure improvement is
sustained
implement preventative strategies targeting
adverse patient events and assure staff is familiar
Quality Improvement
Standard – PI projects
number and scope of projects reflects scope and complexity
of the organization
document projects being conducted – including (minimum)
reason for implementing the project and a description of the
project’s results
Standard – GB responsibilities – ensure that the QAPI
program:
defined, implemented, and maintained
addresses the ASC’s priorities and all improvements are
evaluated for effectiveness
clearly establishes expectations for safety
adequately allocated sufficient staff time, information
systems and training to implement the program
Patient Rights
4 CfC expressed rights
Right to make informed decisions regarding
the patients care
Right to exercise his or her rights without
being subjected discrimination or reprisal
Voice grievances regarding treatment or
care that is (or fails to be) furnished
To be fully informed about a treatment or
procedure and the expected
Patient Rights
ASC must inform the patient of patient’s
rights and must protect and promote the
exercise of such rights
Notice of rights
provide patient verbal and written notice of
patient’s rights
in advance of the date of the procedure
in a language and manner that the patient
understands
Patient Rights
Post the written notice of rights in place(s) where it
will be noticed by patients waiting for treatment,
including:
name, address, phone of State agency where patient can
report complaint
o CDC (www.cdc.gov/mmwr/international/relres.html)
website for Office of the Medicare Beneficiary
Ombudsman (www.cms.hhs.gov/center/ombudsman.asp)
Disclose physician financial interests or ownership in
the ASC
in writing
In advance of the date of the procedure
In accordance with the “intent” of part 420 of this sub
chapter
Part 420 of this subchapter
42 Code of Federal Regulations Sec. 420
Subpart A—General Provisions
§ 420.1 Scope and purpose.
§ 420.3 Other related regulations.
Subpart B [Reserved]
Subpart C—Disclosure of Ownership and Control Information
§ 420.200
§ 420.201
§ 420.202
§ 420.203
§ 420.204
§ 420.205
§ 420.206
Purpose.
Definitions.
Determination of ownership or control percentages.
Disclosure of hiring of intermediary's former employees.
Principals convicted of a program-related crime.
Disclosure by providers and part B suppliers of business transaction information.
Disclosure of persons having ownership, financial, or control interest.
Subpart D—Access to Books, Documents, and Records of Subcontractors
§ 420.300
§ 420.301
§ 420.302
§ 420.303
§ 420.304
Basis, purpose, and scope.
Definitions.
Requirement for access clause in contracts.
HHS criteria for requesting books, documents, and records.
Procedures for obtaining access to books, documents, and records.
Part 420 of this subchapter
42 Code of Federal Regulations
Sec. 420
(a) Information that must be disclosed. A
disclosing entity must submit the following
information in the manner specified in paragraph
(b) of this section:
(1) The name and address of each person with an
ownership or control interest in the entity or in
any subcontractor in which the entity has direct
or indirect ownership interest totaling 5 percent
or more. In the case of a part B supplier that is a
joint venture, ownership of 5 percent or more of
any company participating in the joint venture
should be reported. Any physician who has been
issued a Unique Physician Identification Number
by the Medicare program must provide this
number.
Patient Rights
Advanced Directives
Provided the patient in advance of the date of the
procedure:
information concerning policies on advanced directives
description of applicable state health and safety laws
o Ascension Health
(www.ascensionhealth.org/ethics/public/issues/ADR_StatebyState_5305.pdf)
And if requested, official state advanced directives form
o US Living Will Registry
(www.uslivingwillregistry.com/forms.shtm)
Inform patient of right to make informed decisions
regarding their care
Document in MR whether or not the patient has
executed an advanced directive
Patient Rights
Submission and investigation of
grievances
grievance policy documenting existence,
submission, investigation and disposition of a
patient’s written or verbal grievance to ASC
related to mistreatment, neglect, verbal,
mental sexual or physical abuse
document grievance
reported immediately to person in authority
if substantiated, reported to state and/or local
authority
specify timeframe for review and response
Patient Rights
investigate all alleged grievances about care provided
document how grievance was addressed and written
notice of decision to patient including
o
o
o
o
name of contact person at ASC
steps taken to investigate
results of grievance process
date grievance process completed
Respect for property and person
no discrimination or reprisal
voice grievances regarding treatment
be fully informed about treatment / procedure and
expected outcomes prior to procedure
if incompetent, rights of patient exercised by person
appointed to act on behalf of patient
Patient Rights
Privacy and safety
receive care in a safe setting
free from all forms of abuse or harassment
Confidentiality of clinical records
comply with HIPAA related to privacy and security
of PHI
Infection Control
ASC maintains ongoing program to
prevent, control, and investigate
infections and communicable diseases:
include documentation that ASC is following
nationally recognized infection control
guidelines
Program is:
under direction of designated and qualified
professional with specialized training in infection
control
integral part of QAPI program
responsible for providing plan of action for
preventing, identifying and managing infections and
communicable diseases and immediately
implementing corrective and preventative measures
resulting in improvement
Pt admission, assessment and discharge
ASC ensures patient has appropriate
pre-surgical and post-surgical
assessments
all elements of discharge requirements
are met
Pre-surgical H&P
not more than 30 days before date of
surgery
comprehensive medical H&P completed by a
physician or other qualified practitioner
(state defined)
Pt admission, assessment and discharge
Upon admission
pre-surgical assessment completed by a physician or
other qualified practitioner
includes:
updated medical record entry documenting an exam for
any changes in the patient’s condition since the H&P
patient allergies to drugs and biologicals
placed in MR prior to surgical procedure
Post surgical assessment
condition must be assessed and documented in the
MR by a physician or other qualified practitioner or
RN with post –op experience
post surgical needs must be assessed and included in
the discharge notes
Pt admission, assessment and discharge
Discharge – ASC must:
provide patient with written discharge instructions
and overnight supplies
make FY appointment with physician when appropriate
either prior to procedure or before discharge,
provide
prescriptions
post-op instructions
Physician contact information for follow-up care
ensure patient has discharge order signed by the
physician who performed the procedure
ensure patients are discharged in the company of a
responsible adult, except patients exempted by the
attending physician
Thank You !
Questions?