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?