medical staff bylaws: impact of recent regulatory changes...

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Presenting a live 90-minute webinar with interactive Q&A

Medical Staff Bylaws: Impact of Recent

Regulatory Changes and Best Practices Complying With CMS and Updating Hospital Governance Documents

Today’s faculty features:

1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific

WEDNESDAY, SEPTEMBER 13, 2017

Richard D. Barton, Partner, Procopio Cory Hargreaves & Savitch, San Diego

Adrienne E. Marting, Partner, Nelson Mullins Riley & Scarborough, Atlanta

Alma L. Saravia, Shareholder, Flaster/Greenberg, Cherry Hill, N.J.

Elizabeth A. (Libby) Snelson, Esq., President, Legal Counsel for the Medical Staff, St. Paul, Minn.

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MEDICAL STAFF BYLAWS: IMPACT OF RECENT

REGULATORY CHANGES AND BEST PRACTICES

Complying With CMS and Updating Hospital Governance Documents

September 13, 2017

Richard D. Barton, Esq.

Partner

[email protected]

© 2017 Procopio, Cory, Hargreaves & Savitch LLP

6

Medical Staff Bylaws in an Ever Changing

Landscape


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“The traditional medical staff structure

must evolve to effectively reflect cultural,

regulatory and procedural change. By

updating medical staff bylaws to

transform physician culture and staff

organization, hospitals and physicians

can help achieve continual

improvement.”

Brooke Murphy, Becker’s Hospital

Review, March 22, 2017


8

Background

• CMS Conditions of Participation and Interpretive Guidelines

– “These proposed changes would modernize hospital and critical

access hospital (CAH) requirements, improve quality of care, and

support HHS and CMS Priorities.” Executive Summary, June 16,

2016 Hospital and Critical Access Hospital (CAH) Changes To

Promote Innovation, Flexibility, and Improvement in Patient Care


9

Background

• 2014 Final Rule

– On May 12, 2014, CMS adopted final rule entitled Medicare and

Medicaid Programs; Regulatory Provisions to Promote Program

Efficiency, Transparency, and Burden Reduction


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Background

– Key Changes in 2014 Final Rule

• Governing Body (§482.12)

– Composition

• Medical Staff

– Expansion of Eligible Members- AHP’s

– Single Unified Medical Staff in Hospital Systems


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Is the Regulatory Environment Keeping Pace?

• Physician Employment

• Non-Physician Practitioners

• Value-Based Purchasing and Coordination of Care

• System Integration and Physician Alignment

• Overlapping Structures

– ACO’s, PSO’s, MSO’s and Physician Networks


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Changing Delivery Models

• Increased physician employment

– The proportion of physicians employed by hospitals rose 50

percent between 2012 and 2015, accounting for 38 percent of

all practicing physicians in 2015, according to a 2016 Physicians

Advocacy Institute report.

– Corporate Practice of Medicine exceptions

• Foundation Model


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• Expansion of Membership to Non-Physician Practitioners

– CMS revised its definition of medical staff in its final rule issued

May 2012, allowing hospitals the flexibility to extend

membership opportunities to non-physician practitioners in

accordance with state law.

– Challenges:

• Privileging and Scope of Practice

• Hearing Rights


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• Demand for Efficiency and Care Coordination

– Increased use of Outpatient Care Settings

– Increased use of Contracting for Inpatient Services

• Hospitalists

• “Exclusive” vs. Non-Exclusive Contracting


15


• System Integration and Physician Alignment

– Joint Ventures

– Physician Networks and Group Models

– MSO’s

– ACO’s

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Single Unified Medical Staffs– An Update

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CMS Condition of Participation

• On May 16, 2012, CMS published a final rule that allowed

one governing board to oversee multiple hospitals in a multi-

hospital system

– 42 CFR section 482.22

• CMS left multi-hospital systems with a choice– separate or

unified hospital medical staffs

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Unification of Medical Staffs in Multi-Hospital

System

• CMS retained the original Conditions Of Participation

language but added new requirements

– “The hospital must have an organized medical staff that

operates under bylaws approved by the governing body, and

which is responsible for the quality of medical care provided to

patients by the hospital”

• CMS reinterpreted this language by adding new provisions that must

first be meet before unification of medical staff in a multi-hospital

system can occur

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Unification of Medical Staffs in Multi-Hospital

System (cont.)

• A hospital must actively address why it decided to have a

unified Medical Staff

– A multi-system hospital may elect to have a unified and integrated

Medical Staff for its member hospitals after determining that such an

arrangement is in accordance with all applicable state and local laws

– Each separately certified hospital must demonstrate that it has met

the 4 requirements before it has a unified Medical Staff for multiple

hospitals

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A Single, Unified Medical Staff

• Board must agree to a unified and integrated Medical Staff

• Unified Medical Staff would be:

– Composed of Medical Staff members from each hospital in the

system

– Each member would be eligible to take on leadership roles on

various committees and subcommittees

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Process to Unify Medical Staff

• Majority Vote By Members of Each Medical Staff

– The Medical Staff members in each hospital in the system must

decide to either accept a unified and integrated Medical Staff

structure or to opt out and maintain a separate and distinct

Medical Staff for their respective hospital

– The Medical Staff of each separate hospital must be advised

of their rights to opt out of the unified Medical Staff structure

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Process to Unify Medical Staff (cont.)

• Development of System-Wide Bylaws

– The unified Medical Staff must have bylaws, rules, and

requirements that describe the processes for self-governance,

appointment, credentialing, privileging, and oversight, as well as

its peer review policies and due process rights

• Consider Local Issues and Unique Attributes of Each Hospital

– The unified Medical Staff must ensure that local issues are duly

considered and addressed

– The unified Medical Staff must take into account each member

hospital's unique attributes and differences in patients

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Factors To Consider When Creating Unified Hospital

Medical Staff

• Decide whether to create subcommittees of the Medical

Staff Executive Committee at each hospital to handle

hospital-specific peer review and physician issues

• Centralizing other committees across the system?

– Credentials, Utilization Management, Medical Records

• Peer review sharing agreement needed to share peer review

information?

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Additional Factors to Consider

• Economic Credentialing– if provider’s privileges are

terminated from Medical Staff of multi-hospital system,

provider could be prohibited from practicing at multiple

hospitals

• Multi-hospital systems across state lines– how do different

state laws affect ability to govern 1 Medical Staff

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Using Attributes of Single United Medical Staffs

• If your multi-hospital system is not united, still consider

implementing attributes of a Single United Medical Staff:

– System-wide Medical Staff Bylaws, Rules & Regulations, Policies

– Peer review sharing agreements

– Reciprocal privileging process

– Centralized credentialing

26


Thank you!

Richard D. Barton

[email protected]

619.515.3299

www.flastergreenberg.com Pennsylvania | New Jersey | Delaware | New York

Speaker:

Alma L. Saravia, Esq.

[email protected]

856-661-2290

September 13, 2017

mailto:[email protected]

www.flastergreenberg.com

• NPDB collects and releases certain information relating to the professional competence and conduct of physicians, dentists, and other health care practitioners.

• NPDB mandates that health care entities file reports and make queries about physicians and dentists.

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• Three main laws establish NPDB reporting requirements: • Title IV of the Health Care Quality Improvement

Act

• Section 5 of the Medicare and Medicaid Patient and Program Protection Act of 1987

• Section 221(a) of the Health Insurance Portability and Accountability Act of 1996

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• NPDB information alerts hospitals that a more comprehensive review of a physician or dentist should occur.

• NPDB information should be used in combination with other sources to make a determination on clinical privileges.

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• NPDB Guidebook is published by the Dept. of Health and Human Services.

• The 2015 Guidebook is the first update since 2001.

• Guidebook has been relied upon by health care facilities – viewed as a valuable tool.

• Guidebook is a policy manual that informs the health care community about the NPDB requirements.

31


• 2015 Guidebook reflects regulatory and legislative changes.

• Guidebook “clarifies” areas where there has been confusion about whether to report.

• Changes reflect concern that hospitals are “under-reporting”.

32


• Guidebook is advisory – it contains “interpretations” of health care entities’ reporting obligations.

• Significant new and expanded interpretations of reportable events.

• The 2015 Guidebook revision contains new interpretations for reporting “adverse clinical privileges actions”.

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• Guidebook states that NPDB will not defer to an entities’ Bylaws or written policies when determining whether an action met reporting requirements.

• Many hospitals’ Medical Staffs developed Bylaws based upon the guidance in the 2001 Guidebook.

• Hospitals must review new interpretations and consider changes to Bylaws and policies.

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• Adversely affecting means reducing, restricting, suspending, revoking, or denying clinical privileges or membership in a health care entity.

• Clinical privileges means the authorization by a health care entity to a health care practitioner for the provision of health care services, including privileges and membership on the medical staff.

35


• Adverse clinical privileges actions are:

• Based on a physician’s or dentist’s professional competence or professional conduct that adversely affects, or could adversely affect, the health or welfare of a patient.

• Hospitals must report adverse clinical privileges actions if:

• the action is for a period longer than 30 days.

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• Suspensions, restrictions, revocations, denials or other actions are reportable if they meet Guidebook reporting criteria.

• Hospitals’ Bylaws and policies should be revised so that suspensions or restrictions are reportable when they meet the Guidebook’s requirements.

37


• Acceptance of a physician’s or dentist’s surrender or restriction of clinical privileges

• while under investigation for possible professional incompetence or improper professional conduct, or

• in return for not conducting such an investigation or not taking a professional review action that otherwise would be required to be reported.

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• The hospital taking an action must determine whether the competence or conduct adversely affects or could affect the health and welfare of a patient.

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• A restriction of privileges is reportable IF it is based upon clinical competence or professional conduct that “leads to the inability of a practitioner to exercise his or her own independent judgment in a professional setting.”

40


• Hospitals must distinguish between a routine administrative action or a professional review action.

• Reporting does not apply to threshold eligibility issues.

• Adverse clinical privileges actions are reportable when final.

41


• Hospitals’ MECs should have a defined procedure for evaluating competence or conduct issues.

• Incompetence could be not performing a procedure safely.

• Misconduct could be disruptive behavior that affects the ability of others to care for patients safely.

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• If a physician or dentist withdraws an application while under “investigation” for possible competence or conduct issue OR in return for not conducting an investigation or taking action, then the action must be reportable.

43


• Withdrawal of an application for renewal of appointment or privileges while the physician or dentist is under investigation is reportable regardless of whether he or she knew of the investigation at the time of the withdrawal.

44


• Denial of an initial application is reportable IF the denial is based on professional competence or conduct that adversely affects, or could affect, the health or welfare of patients.

• Not reportable if denial due to failure to meet credentialing criteria.

45


• Guidebook has a broad definition of an investigation and it notes that the term is interpreted "expansively”.

• Guidebook defines an investigation as a “formal, targeted process . . . used when issues related to a specific practitioner’s professional competence or conduct are identified”.

46


• Bylaws may not have adopted precise definitions of investigations.

• Hospitals must determine when an investigation is deemed to have begun, when it ends, and when a resignation or surrender must be reported.

• Investigation must concern competence or conduct.

47


• Hospitals must be able to produce evidence that an investigation began before the surrender of privileges.

• Examples of evidence include: minutes, excerpts of committee meetings, orders from officials directing investigations or notices to physicians or dentists.

48


• Guidebook states that a routine, formal peer review process which “evaluates, against clearly defined measures, the privilege-specific competence of all practitioners” is not considered an “investigation”.

49


• If a proctor is assigned to a physician or dentist:

• as a result of a professional review action related to competence or conduct;

• for more than 30 days

• action must be reported if proctor must approve cases or be present to watch performance.

50


• Summary suspensions are reportable after 30 days even if they are not final.

• Must be based upon competence or conduct.

• It does not matter what the hospital calls the suspension (summary, immediate, emergency, precautionary or anything else).

51


• If a summary suspension has not lasted more than 30 days (and if it meets the competence or conduct test), it may be reportable if it is expected to last more than 30 days.

• If the summary suspension ends before the 30 days, the report should be voided.

• If summary suspension is confirmed, then it takes effect on date when first imposed.

52


• Bylaws should provide notice to members of the initiation of an investigation.

• Notice should be in writing.

• Bylaws should define when an investigation commences and ends.

53


• Guidebook: may be reportable BUT if the result of automatic suspension or administrative action, DO NOT report.

• Guidebook, Q&A states "cut and paste“ notes reportable if suspension more than 30 days and could adversely affect patient.

• Must be a process to determine whether potential for patient harm.

54


• If the physician or dentist takes a leave of absence for rehabilitation, then it is not reportable.

• Failing to enter rehabilitation when “directed” to do so and to give up privileges OR face investigation for competence or conduct issues, IS reportable.

55


• If the physician or dentist surrendered the temporary privileges in return for not investigating issues related to competence or conduct, then it is reportable.

56


• The Federation of State Medical Boards defines “competence” as “possessing the requisite abilities and qualities . . . to perform effectively in the scope of professional physician practice while adhering to ethical standards.”

57


• Hospitals are mandating that physicians over a certain age must be tested for competence.

• In 2015, the American Medical Association, Council on Medical Education released a report on “Competency and the Aging Physician” which called for guidelines to be issued.

58


• The reasons a physician or dentist may be alleged as incompetent and adversely affecting patient care are varied and complex.

• Attaining a certain age calls for different solutions than when evaluating a physician or dentist who may be jeopardizing a patient.

59


• Cooper University Hospital in Camden, New Jersey now mandates that physicians over age 72 must have their cognitive abilities tested to remain on staff.

• Does a lack of current competence by an aging physician mean that patients are adversely affected?

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www.flastergreenberg.com Pennsylvania | New Jersey | Delaware | New York

Alma L. Saravia, Esq. [email protected] 1810 Chapel Avenue West Cherry Hill, New Jersey 08002 856-661-2290

mailto:[email protected]

BEST MEDICAL STAFF BYLAWS

PRACTICES

Elizabeth “Libby” Snelson

Legal Counsel for the Medical Staff PLLC

[email protected]

BEST MEDICAL STAFF

BYLAWS PRACTICES

• Aging

• Conflict of Interest

• Compliance Code

• Code of conduct

• Employed Physicians

• Dispute Resolution

63

AGING PHYSICIANS

• No “Magic Number” Consensus

• Age-based Credentialing Standard

• Discrimination Statutes

• No Processes for Handling Age Testing Results

• Existing Bylaws Prohibitions

64

BEST PRACTICES: AGING PHYSICIANS

• Focus on core competencies for all

• Strengthen proctoring & monitoring

• Coordinate re-entry after rehab/re-education

• Activate thresholds for referral/reporting

• Promote Physician Health Programs

65

DON’T TAKE MY WORD FOR IT….

“The medical staff implements a process to

identify and manage matters of individual

health for licensed independent practitioners

which is separate from actions taken for

disciplinary purposes.”

Joint Commission Standard MS11.01.01

66

SAMPLE BYLAWS: MEDICAL STAFF HEALTH COMMITTEE

The medical staff health committee receives reports from any source regarding

possible impairment of a member, including self-referrals, and screens out

specious or inappropriate reports. As appropriate, the committee refers

members to the Physician Health Service, other medical or surgical specialists, or

other sources, for evaluation and treatment of condition affecting the member’s

ability to safely practice. The committee assists members with post-evaluation

and treatment monitoring. Referrals, monitoring and all member-related activity

by the committee and its members is confidential; however, should a member fail

to comply with treatment plans and monitoring or otherwise jeopardize patient

safety, the committee refers the member to the medical executive committee for

corrective action. The committee organizes staff-wide education about

professional impairment issues.

Massachusetts Medical Society Model Medical Staff Bylaws

Implementing JC standard MS.11.01.01 67

CONFLICT OF INTEREST

FINANCIAL CONFLICTS

• EMPLOYED/CONTRACTED BY

HOSPITAL COMPETITORS

• EMPLOYED/CONTRACTED BY

HOSPITAL

68

BEST PRACTICES: CONFLICT OF INTEREST

Sample Bylaws

Responsibilities of Leadership and Committee Service

A .To provide a means for informed decision-making, officers, department chairs,

and all those appointed to committees must disclose potential conflicts of

interest, including employment and contracting relationships with the Hospital or

with entities competing with the Hospital, as relevant to the position held and the

circumstances.

B. Members shall not use or disclose any information obtained as a result of their

medical staff leadership position for any purpose other than the furtherance of

quality medical care in the Hospital. Neither medical staff membership or any

clinical privilege is affected by any conflict of interest or the declaration of any

potential conflict of interest.

C. Participation in medical staff activities and processes shall be carried out in

good faith for the promotion of quality patient care. Medical staff members

cannot be fired from their hospital employment or be terminated from hospital

contracts because they fulfill Medical Staff assignments in good faith consistent

with these bylaws.

69

COMPLIANCE CODE

• Hospital Compliance Code Inconsistencies with Medical Staff Bylaws:

• EMTALA

• Code of Conduct

• Peer Review Process

• AMA Guidelines for Hospital Compliance Program Audits and Investigations, available at http://www.ama-assn.org/ama/pub/about-ama/our-people/member-groups-sections/organized-medical-staff-section/helpful-resources.page?

70

http://www.ama-assn.org/ama/pub/about-ama/our-people/member-groups-sections/organized-medical-staff-section/helpful-resources.page



















BEST PRACTICE: COMPLIANCE CODE COORDINATION

Sample Bylaws:

The MEC shall….Oversee that portion of the corporate compliance plan that pertains to the medical staff members and has been adopted by the Medical Executive Committee through receipt of an annual report.

Policy that is applicable to the medical staff must be adopted by the MEC

71

CODE OF CONDUCT

“Leaders create and maintain a culture of safety and quality throughout the hospital.”

Element of Performance 4 :“Leaders develop a code of conduct that defines acceptable behavior and behaviors that undermine a culture of safety.”

Joint Commission standard LD.03.01.01

effective July 2012

72

BEST PRACTICES: CODE OF CONDUCT

Sample Bylaws:

Appropriate Conduct

The following kinds of conduct by medical staff members are

not restricted by these bylaws:

A. Advocating for patients.

B. Criticism that is meant to improve care.

C. Legitimate business activities that may or may not

compete with the hospital.

73

EMPLOYED PHYSICIANS

• Consistent Standards and Application of

Standards in Credentialing, Peer Review

• Hearing and Appeals Rights

• Protection from Manipulation/Retaliation

• Standing as Medical Staff Members

74

BEST PRACTICES: EMPLOYED PHYSICIANS

Sample Bylaws

EMPLOYED OR CONTRACTED MEMBERS

Members who are employed or contracted by the Hospital to render services to it shall

be subject to the Bylaws, Rules and Regulations and policies of the Medical Staff

irrespective of whether the services rendered pursuant to such arrangement involve clearly

clinical responsibilities, purely administrative responsibilities, or both clinical and

administrative responsibilities (medico-administrative positions). Physicians and oral

maxillofacial surgeons so engaged in a full-time or part-time capacity must apply for and

become members of the Medical Staff, as a condition precedent to performance of services

for the Hospital. Before physicians or oral maxillofacial surgeons are engaged by the

Hospital in administrative positions with related clinical responsibilities, the Hospital shall

seek the advice and recommendation of the Executive Committee. Unless there is a

written contract to the contrary, Medical Staff membership and privileges will continue

after the termination of the employment or contractual relationship with the Hospital.

Medical Staff members cannot be terminated from their Hospital employment or be

terminated from Hospital contracts because they fulfill Medical Staff assignments in good

faith consistent with this section and these Bylaws.

75

BEST PRACTICES: EMPLOYED PHYSICIANS

Sample Bylaws:

Employed members may qualify for election to medical

staff leadership but must disclose their employment

relationships as potential conflicts of interest. Massachusetts Medical Society Model Medical Staff Bylaws

76

DISPUTE RESOLUTION

Two Levels:

• Joint Commission Standard LD.02.04.01, Element of Performance 4:

“The conflict management process includes the following:

- Meeting with the involved parties as early as possible to identify the conflict

- Gathering information regarding the conflict

- Working with the parties to manage and, when possible, resolve the conflict

- Protecting the safety and quality of care.”

• Joint Commission Standard MS 01.01.01 Element of Performance 10 :

“The organized medical staff has a process which is implemented to manage conflict between the medical staff and the medical executive committee on issues including, but not limited to, proposals to adopt a rule, regulation, or policy or an amendment thereto. …”

77

BEST PRACTICES: DISPUTE RESOLUTION

• Exempt Peer Review

• Avoid Self-Executing Resolution

that Conflict with Medical Staff

Bylaws

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BEST PRACTICES: RESOURCES AVAILABLE FOR MEDICAL

STAFFS & COUNSEL

• AMA Physician's Guide to Medical Staff Organization Bylaws 6th edition

• California Public Protection & Physician Health

CPPPH Guidelines http://www.cppph.org/cppph-guidelines/

• Check My BYLAWG at snelsonlaw.com

79

http://www.cppph.org/cppph-guidelines/





ELIZABETH “LIBBY” SNELSON, ESQ. LEGAL COUNSEL

FOR THE MEDICAL STAFF, PLLC

[email protected]

80

Adrienne E. Marting [email protected]

404.322.6299