ASCs 2009ASCs 2009Nashville, TNNashville, TN

Dawn Q. McLane RN, MSA, CASC, CNORLakeshore Surgicare (NRG Managed) – Administrator

Jonathan Beal –ASC Association

Changes to Medicare’s Conditions for Coverage

Overview of ChangesOverview 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 ChangesSummary of ChangesConditions 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 ScopeProgram DataProgram ActivitiesPerformance Improvement ProjectsGoverning Body Requirements

Revised

Summary of Changes Summary of Changes Continued…Continued…

EnvironmentPhysical EnvironmentSafety from FireEmergency EquipmentEmergency Personnel

No Change

Medical Staff Membership and Clinical Reappraisals Other practitioners

No Change

Nursing ServicesOrganization and Staff

No Change

Medical RecordsOrganizationForm and Content

No Change

Pharmaceutical ServicesAdministration of Drugs

No Change

Summary of Changes Summary of Changes Continued…Continued…

Laboratory and Radiologic ServicesLaboratory ServicesRadiologic Services

Revised

Patient RightsNotice of RightsAdvance DirectivesSubmission and Investigation of GrievencesExercise of Rights and Respect for Property and PersonPrivacy and SafetyConfidentially of Clinical Records

New

Infection ControlSanitary EnvironmentInfection Control Program

New

Patient Admission, Assessment and Discharge Admission and Pre-Surgical Assessment Post- Surgical Discharge Discharge

New

Change in Definition of an Change in Definition of an ASCASC

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 Governing Body and ManagementManagement

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 Governing Body and ManagementManagement

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 ImprovementQuality 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 ImprovementQuality 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 ImprovementQuality 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 RightsPatient 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 RightsPatient 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 RightsPatient 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 Part 420 of this subchapter 42 Code of Federal Regulations Sec. 42 Code of Federal Regulations Sec. 420420

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 Purpose.§ 420.201 Definitions.§ 420.202 Determination of ownership or control percentages.§ 420.203 Disclosure of hiring of intermediary's former employees.§ 420.204 Principals convicted of a program-related crime.§ 420.205 Disclosure by providers and part B suppliers of business transaction information.§ 420.206 Disclosure of persons having ownership, financial, or control interest.

Subpart D—Access to Books, Documents, and Records of Subcontractors

§ 420.300 Basis, purpose, and scope.§ 420.301 Definitions.§ 420.302 Requirement for access clause in contracts.§ 420.303 HHS criteria for requesting books, documents, and records.§ 420.304 Procedures for obtaining access to books, documents, and records.

Part 420 of this subchapter Part 420 of this subchapter 42 Code of Federal Regulations 42 Code of Federal Regulations Sec. 420Sec. 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 RightsPatient 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 RightsPatient 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 RightsPatient Rights investigate all alleged grievances about care

provided document how grievance was addressed and

written notice of decision to patient including o name of contact person at ASC o steps taken to investigateo results of grievance processo 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 RightsPatient 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 ControlInfection 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 Pt admission, assessment and dischargedischarge

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 Pt admission, assessment and dischargedischarge

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 Pt admission, assessment and dischargedischarge 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 !Thank You !

QuestionsQuestions??