GHA TELNET DRAFTING POLICIES AND PROCEDURES

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					MONTANA HOSPITAL ASSOCIATION NOVEMBER 18-19, 2003 DRAFTING POLICIES AND PROCEDURES
Michelle A. Williams, J.D. Alston & Bird LLP 404-881-7594 mawilliams@alston.com Gary McClanahan, J.D. Alston & Bird LLP 404/881-7632 gmcclanahan@alston.com

I.

WHAT ARE POLICIES AND PROCEDURES?

WHAT ARE POLICIES AND PROCEDURES?
• Policies are a reflection of the Hospital’s mission and operations • Procedures are a description of the steps necessary to accomplish a policy • Policies and Procedures have intended uses and get used in unintended ways

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WHAT ARE POLICIES AND PROCEDURES?
• Policy and Procedure Manual is first thing surveyors and investigators request regardless of what Agency they represent
• DPHHS for Hospital Licensure • CMS for EMTALA • OIG for Billing

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INTENDED USES
• Manuals Are Used
 To Teach  To Evidence Compliance with Law  To Document / Defend

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INTENDED USES
• To Teach
– Operationalize Communication – Minimize “Hand Me Down” Education

• Required By Law
– CAH Conditions of Participation – State Hospital Licensure Law – Federal CLIA Law

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INTENDED USES
• Contractually Required
 Hospital-Based Physician Agreements

 Transfer Agreements
 Corporate Integrity Agreements
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INTENDED USES
• “Voluntary” Requirements
 Accreditation

 OIG Hospital Compliance Guidance

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OIG HOSPITAL COMPLIANCE GUIDANCE REQUIREMENTS
 Risk Identification. The first element of a Compliance Plan is the development and distribution of written policies and procedures that identify specific areas of risk to the hospital.  Standards of Conduct. Hospitals should develop standards of conduct that:
 include a clear commitment to compliance by the hospital’s senior management.  articulate the hospital’s commitment to comply with all Federal and State standards, with an emphasis on preventing fraud and abuse.  should be distributed to, and comprehensible by, all employees (e.g., translated into other languages and written at appropriate reading levels).

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OIG HOSPITAL COMPLIANCE GUIDANCE
 Risk Areas. The OIG Guidance focuses on specific areas of potential fraud and provides specific examples of policies that should be implemented to ensure compliance in these areas.  Claims Development and Submission Processes and Code Gaming
(upcoding, DRG creep). There should be policies that create a mechanism for the billing or reimbursement staff to communicate effectively and accurately with the clinical staff.  Ensuring That Claims Are Submitted Only for services that are medically necessary and that were ordered by a physician or other appropriately licensed individual.  Anti-Kickback and Self-Referral Concerns. The hospital should have policies and procedures in place with respect to compliance with Federal and State anti-kickback statutes, as well as the Stark physician self-referral law.  Accurate and Timely Reporting of Bad Debts and Credit Balances to Medicare and other Federal health care programs.  Records System. There should be a records system which should establish policies and procedures regarding the creation, distribution, retention, 10 storage, retrieval and destruction of documents.

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UNINTENDED USES
• Discoverable
 Surveys
• Part of Plan of Correction

 Lawsuit Defense
• Define Standard of Care

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EXAMPLES OF POLICY MANUALS
• • • • • • • • • Administrative Credentialing Human Resources Purchasing Nursing Privacy Infection Control Compliance Disaster • Departmental Level ■ Laboratory ■ Radiology ■ Medical Records

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POLICY MANUAL TYPE DOCUMENTS
• • • • • • • Hospital Bylaws Medical Staff Bylaws Medical Staff Rules and Regulations Employee Handbook Compliance Plan Quality Improvement Plan Code of Conduct
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WHAT IS THE DIFFERENCE?
• Plans / Bylaws / Handbooks
 Subject matter framework  Source of policies and procedures

• Policies and Procedures Operationalize Plans and Bylaws
• • • • Who How Where When
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INVENTORY
Manuals Bylaws/Plans/Other

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II. ELEMENTS OF A POLICY AND PROCEDURE

POLICY AND PROCEDURE POLICY
• Identify Need • Review Existing Manuals / Bylaws / Plans / Handbooks
 Related Policies  Pre-existing Policies Which are Similar

• • • • •

Draft / Proof / Consensus / Trial Read by Users Approval of Committee / Administrator / Board Publication To Proper User Group Inservice / Test Revisions
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BIG SKY HOSPITAL ADMINISTRATIVE MANUAL
Title: Date Issued: Replaces: Date Revised: Approved By: Policy No:

Purpose or Objective:
Policy: Procedure:

Materials/Equipment:
Exceptions: Position Responsibility: Rule/Cite/Tag: Hospital Policy Cross Reference:

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ELEMENTS OF A POLICY AND PROCEDURE
• What is a “Purpose”?
    Goal Objective Aim What do you want to achieve?

• What is a “Policy”?
 Links the Purpose and Procedure  Describes How the Purpose will be Achieved

• What is a “Procedure”?
 The Who, the What, the When, the Where  Applies the Policy  Series of Steps

• How is Policy Different from a Procedure?

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III. PRACTICE POINTERS

DRAFTING DON’Ts
• “Must”/“Shall” • Assume the “Subject”
 “Dr. Called”

• Use of Abbreviations • Time Designations
 Immediately / ASAP

• Forms Without Policies • Use of Negative Statements
 “Never”  “Do Not”

• Use of Jargon

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DRAFTING DO’s
• Use of the Word “May” • Use of the Word “Should” • Read Aloud

• Test on Users Before Adoption
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USE OF DEFINED TERMS
• Definition • Consistent Use of Defined Term • Capitalize

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POLICIES AND PROCEDURES
• • • • • How To Draft A Policy and Procedures How To Obtain Approvals How To Revise A Policy and Procedures How To Retain Old Policies and Procedures How To Document New Employee Training and Annual Training of Policies and Procedures • How To Inservice New/Revised Policies and Procedures
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POLICY PITFALLS
• Survey citations for “Not Following Hospital Policies on ________” • Passive Voice Rather Than Active Voice • “Prescriptive” Policies • Drafts not marked “Draft”; Undated Drafts • Use of terms “standards” “guidelines” “policy” “protocol” interchangeably or without definition
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POLICY PITFALLS
• No Review and Revision Conducted • Solitary Drafting and Annual Review versus “Qualified Group of Professionals” • No Tracking and Retention of Policy Revisions • Not Following Policy and Procedure • No Monitoring to Confirm Policy and Procedure Being Followed or If Not, Why Not
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READING COMPREHENSION
• Grade Level: 4th and 8th Grade Reading Level
 SMOG - 10 consecutive sentences at the beginning of the document, 10 consecutive sentences in the middle, and 10 consecutive at the end. Count the number of multi-syllable words (3 or more) including repetitions. Then take the nearest perfect square root of that number and add 3. That gives you the reading level. Hyphenated words count as one; numbers and abbreviations: pronounce them aloud and count the number of syllables  Word Count Software: Voice and Grade Level
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QUESTIONS

Michelle A. Williams
Michelle Williams practices health care law and is a member of the Firm’s Regulatory Health Care Group and the Products Liability Group. Ms. Williams concentrates her practice on the regulatory aspects of health law and handles Medicare/Medicaid termination actions, EMTALA defense and peer review organization hearings, professional licensure actions and other administrative agency proceedings including those involved in food poisonings and infectious disease look backs. She also works with the Corporate Health Care Practice Group advising on the fraud and abuse and Stark aspects of health care transactions.
Michelle A. Williams Alston & Bird LLP One Atlantic Center 1201 West Peachtree Street Atlanta, GA 30309-3424 404-881-7594 mawilliams@alston.com Practice Areas Compliance Health Care - Regulatory Internet & E-Business Life Sciences Privacy & Data Management Products Liability Education Case Western Reserve University (J.D., 1986) Butterworth Hospital (M.T., 1981) Michigan State University (B.S., B.S., 1978) Admitted to Practice 1992, Georgia 1991, Colorado 1987, Ohio

Prior to law school, Ms. Williams completed her Medical Technologist internship at Butterworth Hospital, an affiliate of Michigan State University, where she received a B.S. in microbiology and public health and a B.S. in animal husbandry. While an undergraduate, she worked at the Michigan State University abattoir in all phases of meat production. Ms. Williams was a registered medical technologist at University Hospitals of Cleveland, Lansing General Hospital and Baystate Medical Center and a laboratory assistant at Michigan State University where she worked on vaccine projects for Brucellosis and Marek’s Disease Herpes Virus. She received her J.D. in 1986 from Case Western University School of Law where she was the Executive Editor of Health Matrix: Quarterly Journal of Health Services Management. Following law school, she served as assistant counsel of University Hospitals of Cleveland, Ohio, a teaching hospital of Case Western Reserve University School of Medicine, and then as associate general counsel of The Mt. Sinai Medical Center, Cleveland, Ohio. She is a member of the American Health Lawyers Association, Chair of the Board of Directors of the American Red Cross Southern Region Blood Services, and past Chair of the Board of Directors of the American Red Cross Fulton County Advisory Board. She is a member of the Board of Visitors for the Centers for Disease Control Foundation, Inc. Ms. Williams is a frequent speaker on HIPAA, e-health, corporate compliance, corporate integrity agreements, fraud and abuse, the Stark Law, hospital physician contracting and recruiting, Medicare/Medicaid issues and EMTALA.

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Gary E. McClanahan
Gary McClanahan is counsel in the firm’s Healthcare Regulatory Group. His practice focuses on regulations affecting transactions among health care providers, particularly the Medicare Anti-Kickback Statute and the Stark Law, as well as on privacy and e-health issues.

Gary E. McClanahan Alston & Bird LLP One Atlantic Center 1201 West Peachtree Street Atlanta, GA 30309-3424 404-881-7632 gmcclanahan@alston.com

Gary is a contributing author to the Georgia Hospital Law Manual, published in 1992 and 1996 by the Georgia Academy of Hospital Attorneys, and the Hospital Managed Care Handbook, published in 1992 by the American Academy of Hospital Attorneys.

Practice Areas Health Care - Regulatory Internet & E-Business
Education University of Texas (J.D., 1984) Harvard University (M.B.A., 1980)

He is admitted to practice in Georgia and North Carolina, and is a member of the State Bar of Georgia, Health Law Section; the State Bar of North Carolina, Health Law Section; the American Health Lawyers Association; and the Georgia Academy of Hospital Attorneys. In other pursuits, Gary serves as the Council Commissioner for the Boy Scouts of America, Atlanta Area Council. Prior to joining Alston & Bird in 1994, Gary was General Counsel and Treasurer of Egleston Children’s Hospital at Emory University. From 1984-1992, he was at King & Spalding, where he concentrated on a transactional health care practice.

Auburn University (B.S., 1978)
Admitted to Practice 2001, North Carolina 1984, Georgia

He received a J.D. with honors from the University of Texas Law School in 1984, an M.B.A. in 1980 from Harvard Graduate School of Business Administration, and a B.S. with honors from Auburn University in 1978.

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