cms final rule – burden reduction ii karen beem, ms, rn hfap standards interpretation 2014 cms...

CMS Final Rule – Burden Reduction II

Karen Beem, MS, RNHFAP Standards Interpretation

2014 CMS Final Rule 2014 Acute Care Hospital Manual v 3 1

PurposePurpose:•The purpose of this training is to discuss new / revised HFAP Accreditation Requirements for Acute Care Hospitals that reflect CMS Requirements published in the May 2014 Final Rule – Burden Reduction II.

•The CMS Final Rule provides hospitals and medical staffs greater flexibility, consistent with State laws, to appoint and grant privileges to physicians and non-physician practitioners.


New / Revised HFAP Standards

• 01.00.05• 03.00.00• 03.00.06• 03.00.10• 03.00.11 (NEW)• 03.00.12 (NEW)• 03.00.13 (NEW)• 03.00.14 (NEW)• 03.00.15 (NEW)

• 23.00.05• 24.00.06• 24.00.07• 31.00.11 (NEW)• 32.00.00• 32.00.01


Key Words

1.Greater flexibility

2.Consistent with State laws

3.Approved by Medical Staff and the Governance


Objectives1. Identify two (2) requirements for the governing body relating to

mandatory consultations with the medical staff.

2. List four (4) requirements associated with a “single, unified medical staff.”

3. Discuss the one (1) significant change that impacts in-house preparation of radiopharmaceuticals.

4. Identify two (2) changes that impact writing orders for outpatient services.


01.00.05 Condition of Participation Governing Body (revised standard)

1.If a hospital is part of a healthcare system with several separately certified hospitals, each with its own Medicare agreement and CCN:

• The governing body of the healthcare system has the option to act as the governing body of each separately certified hospital, unless doing so would conflict with State law.

• The system also has the option to form several governing bodies, each of which is responsible for several separately certified hospitals


01.00.05 Condition of Participation: Governing Body (continued)

If a hospital system has chosen to have one body act as the governing body for multiple separately certified hospitals:

Each hospital must:1) Be separately surveyed, and

2) Independently demonstrate compliance with the CoPs.

2014 Acute Care Hospital Manual v 3 72014 CMS Final Rule


Departments of separately certified hospitals with one system governing body cannot be operationally integrated.

Example: If a system operates three (3) separately certified hospitals in relatively close proximity to each other rather than have them certified as one (1) multi-campus hospital:

1. Each hospital must have its own nursing service.



2. The system :2. May NOT have one (1) integrated nursing service with one

(1) Director of Nursing who manages one nursing staff for all three hospitals

3. May NOT have one integrated schedule that assigns nursing staff among the different hospitals

4. May NOT move staff back and forth between hospitals on an as needed basis, as if they were one hospital.



3. However, the system may have the same individual be the Director of Nursing for each hospital, provided he / she is able to carry out all of the duties of the position in each hospital.

4. Policies and procedures for the nursing service in each hospital may be identical, as long as the services operate separately.



5. It is permissible for one nurse to work at multiple hospitals within the system; but –

• the nurse must have separate work schedules for each hospital that do not overlap.



Policies: 1. A system governing body may adopt identical policies and

procedures for many aspects of a hospital’s operations across all of its hospitals within the system.

2. However, the documentation of such policies and procedures must be clear that the governing body has chosen to apply them to specifically named hospitals.

(This HFAP standard provides specific examples)


01.00.33 Governing Body Periodically Consults with Medical Staff (new)

CMS No Longer Requires the Governing Body:

• To include a member of the medical staff.


01.00.33 Governing Body Periodically Consults with Medical Staff (new)

New Requirement: 1. The governing body must consult directly with the individual

assigned the responsibility for the organization and conduct of the hospital’s medical staff, or designee.

2. At a minimum, this direct consultation must occur

periodically throughout the fiscal or calendar year and include discussion of matters related to the quality of medical care provided to patients of the hospital.


01.00.33 Governing Body Periodically Consults with the Medical Staff (continued)

• “Direct consultation” means that the governing body, or a subcommittee of the governing body, meets with the leader(s) of the medical staff(s) either face-to-face or via a telecommunications system permitting immediate, synchronous communication.

• This regulation does not preclude a hospital from having a member of the medical staff serve as a member of the hospital’s governing body.

• Membership on the governing body by a medical staff member is not sufficient per se to satisfy the requirement for periodic consultation.


01.00.33 Governing Body Periodically Consults with the Medical Staff (continued)

• The governing body must consult with each separately certified hospital’s medical staff leader(s), or his/her designee(s).

• These governing body consultations with the medical staff for each separately certified hospital do not have to be separate.

Example:• The system governing body could periodically have one (1)

meeting that includes the leaders of the medical staff or designee from each hospital within the system.


03.00.01 Eligibility and Process for Appointment to the Medical Staff (revision)

STANDARD:•The medical staff must be composed of doctors of medicine or osteopathy… •Some believed this excluded doctors of dental surgery, dental medicine, podiatry, optometry, chiropractors.

REVISION: •The medical staff must be composed of doctors of medicine or osteopathic medicine. And…


03.00.01 Eligibility and Process for Appointment to the Medical Staff

And…

•In accordance with State law, including scope-of-practice laws, the medical staff may also include other categories of physicians (as listed at §482.12(c)(1)) and non-physician practitioners who are determined to be eligible for appointment by the governing body.


03.00.01 Eligibility and Processfor Appointment to Medical Staff (continued)

1. All practitioners who require privileges to furnish care to hospital patients must be evaluated under the hospital’s medical staff privileging system before the hospital’s governing body may grant them privileges.

2. All practitioners granted hospital privileges must function under the bylaws, regulations and rules of the hospital’s medical staff.

3. The privileges granted to an individual practitioner must be consistent with State scope-of-practice laws.


03.00.01 Eligibility and Process for Appointment to the Medical Staff (continued)

Non-physician Practitioners:•Physician assistant •Nurse practitioner •Clinical nurse specialist •Certified registered nurse anesthetist •Certified nurse-midwife •Clinical social worker •Clinical psychologist •Registered dietician or nutrition professional•Anesthesia Assistant


03.00.01 Eligibility and Process for Appointment to the Medical Staff (continued)

Other types of licensed healthcare professionals with a more limited scope of practice and USUALLY not eligible for privileges unless permitted by State scope of practice:

•Physical Therapist •Occupational Therapist •Speech Language Therapist •Some States - Licensed pharmacists are permitted to provide ordering medications and laboratory tests


03.00.06 Recommendation for Appointment to Governance (continued)

Standard: Examine Credentials

•The medical staff must examine the credentials of all eligible candidates for medical staff membership and make recommendations to the governing body on the appointment.



Standard: Subject to Bylaws, Rules and Regulations

•A candidate who has been recommended by the medical staff and who has been appointed by the governing body is subject to all medical staff bylaws, rules and regulations, in addition to all the requirements of the Medical Staff Condition of Participation.



Standard: Enforcement•The medical staff must enforce its medical staff requirements and take appropriate actions when individual members or other practitioners with privileges do not adhere to the medical staff’s bylaws, regulations, or rules.



Standard: Protection and Due Process Rights•It must likewise afford all members/ practitioners who hold privileges the protections and due process rights provided for in the bylaws, rules and regulations.


03.00.11 Multiple-Hospital Systems:Unified and Integrated Medical Staff (NEW)

1. Definition – Multi-campus Hospital:• A multi-campus hospital is one certified hospital, not several separately certified hospitals. The

hospital has one (1) CCN.

• A multi-campus hospital with several inpatient campuses that are provider-based, remote locations of the hospital is NOT a multi-hospital system.

• A multi-campus hospital may not have separate medical staffs at each campus, since each hospital must have no more than one medical staff.



2. Definition: Multi-Hospital System:• A system consisting of multiple separately-certified hospitals

• Each hospital has a separate CMS Agreement and a separate CNN



Multi- Hospital System:If a hospital is part of a multi-hospital system that wishes to establish a unified medical staff for some or all of its separate hospitals:

•The hospital’s governing body takes the first step toward a unified medical staff by electing to exercise this option.

•The hospital’s governing body must document in writing its decision to elect to use the unified medical staff option CONDITIONED upon:

1. Acceptance of a unified medical staff, as well as its determination that such election does not conflict with State or local laws, including regulations, and that

2. Such election does not conflict with State or local laws



Standard: §482.22(b)(4) If a hospital is part of a hospital system consisting of multiple separately certified hospitals and the system elects to have a unified and integrated medical staff for its member hospitals, after determining that such a decision is in accordance with all applicable State and local laws, …



…each separately certified hospital must demonstrate requirements of the Unified and Integrated Medical Staff:

1) 03.00.12 Members have voted by majority to accept or opt out

2) 03.00.13 Have bylaws

3) 03.00.14 Takes into account each member hospital’s unique circumstances and difference in patient populations and services

4) 03.00.15 Establishes policies and procedures to ensure the needs and concerns expressed by members of the medical staff at each separately certified hospital


03.00.11 Unified and Integrated Medical Staff

Multi-Hospital System:1.A hospital that is part of a system consisting of multiple separately-certified hospitals may use a single unified medical staff that is shared with one or more of the other hospitals in the system.

It is not necessary for each separately-certified hospital within the system to have its own distinct medical staff organization and structure, including: •hospital-specific medical staff bylaws, rules and requirements, •hospital-specific medical staff leadership, 1.hospital-specific credentialing and peer review, etc.


03.00.11 Unified and Integrated Medical Staff

Multi-Hospital System:2.Separately certified hospitals which share a single unified and integrated medical staff must also share a system governing body since –

only one governing body may carry out the governing body’s medical staff responsibilities for a unified medical staff.



When granting practitioners privileges the hospital’s governing body must:

•Specify those hospitals in the system where the privileges apply, since,

•In addition to the qualifications of individual practitioners, the services provided at each hospital must be considered when granting privileges.


03.00.12 Multiple-Hospital Systems:Voting Requirements for Separately Certified Hospitals

(NEW)

Standard:The medical staff members of each separately certified hospital in the system have voted by majority, in accordance with medical staff bylaws, either to:

a)Accept a unified and integrated medical staff structure, or

b)Opt out of such a structure and to maintain a separate and distinct medical staff for their respective hospital;



The decision for a particular certified hospital in a multi-hospital system to use a unified medical staff is a joint one arrived at by: 1.Election of the unified medical staff option by the hospital’s governing body; and 2.Acceptance by a majority of the medical staff members who hold privileges to practice at that particular hospital, in accordance with the medical staff bylaws

3.Those with ONLY telemedicine privileges would not be eligible



• A hospital that is part of a system is expected to have medical staff bylaws, rules and regulations relating to use of a Unified Medical Staff, even if hospital does NOT have a unified medical staff.



The Medical Staff Bylaws address:1.Processes for voting to accept /opt out of a unified medical staff

2.Whether the decision for acceptance or to opt-out is determined by “majority” vs “supermajority”

3.How a vote can be requested

4.Whether all categories of members holding privileges to practice on-site at the hospital are afforded voting rights



The Medical Staff Bylaws address (continued):5.Whether voting will be in writing and open or by secret ballot

6.Minimum interval between votes to accept or opt-out, e.g., once every two years

•If a majority of a hospital’s medical staff voted to use a unified medical staff in the past, the members of the unified medical staff with voting rights and holding privileges to practice onsite at that hospital still retain the right to hold a vote to opt-out at a future date.



Hospitals may NOT:1.Set up bylaws that unduly restrict the rights of medical staff members when voting on the issue of accepting or opting out of a unified medical staff structure

2.Establish different criteria as to which categories of medical staff members have voting rights with respect to a vote to accept or opt out of a unified medical staff than are used for other amendments to the medical staff’s bylaws



Surveyor Tip:

1.What is the evidence that a majority of the medical staff holding privileges voted in favor of a unified medical staff?

2.Do the bylaws, rules or regulations describe a process by which a vote to opt out of using a unified medical staff may be requested and conducted?


03.00.13 Multiple-Hospital Systems: Bylaws of the Unified Medical Staff (NEW)

Standard:The unified and integrated medical staff has bylaws, rules, and requirements that describe its processes for:

Self-governance, Appointment, Credentialing and privileging, and Oversight, as well as Its peer review policies and due process rights guarantees, and include a process for the

members of the medical staff of each separately certified hospital to be advised of their rights to opt out of the unified and integrated medical staff structure


03.00.13 Multiple-Hospital Systems: Bylaws of the Unified Medical Staff (continued)

• The medical staff bylaws that apply to the unified medical staff must identify each separately certified hospital that has elected to use a unified medical staff and therefore, is covered by the unified medical staff bylaws, rules and regulations.


03.00.13 Multiple-Hospital Systems: Bylaws of the Unified Medical Staff (continued)

• The unified medical staff bylaws must provide for a process by which members of the unified medical staff holding privileges to practice onsite at each separately certified hospital are advised that they have the right to vote on whether to opt out

• The hospital must advise medical staff members in writing of their right to vote by majority to opt out when the medical staff membership is first granted and when it is renewed.


03.00.13 Multiple-Hospital Systems: Bylaws of the Unified Medical Staff

Surveyor Tip:

• Do the credentialing and privileging files of members of the medical staff have any evidence of their being notified of their right to vote by majority to opt out?


03.00.14 Multiple-Hospital Systems: Unique Circumstances (NEW)

Standard:•The unified and integrated medical staff is established in a manner that takes into account each member hospital’s unique circumstances and any significant differences in patient populations and service.


03.00.14 Multiple-Hospital Systems: Unique Circumstances (continued)

The separately certified hospitals belonging to a multi-hospital system and using a single unified medical staff may:

1.Be very different from each other, presenting different needs and challenges for the medical staff.

2.Consist of hospitals that differ in size or provide specialized services.

• Such differences could have implications for various medical staff requirements, such as on-call requirements.


03.00.14 Multiple-Hospital Systems: Unique Circumstances

A multi-hospital system may:1.Have implications for medical staff functions such as:

a) the periodic review of credentials and privileges and b) ongoing peer review of the quality of medical care

For example:The development and oversight of standing orders/protocols which must

be specific to each hospital, reflecting the types of services a hospital offers and its patient population.



A multi-hospital system may:1.Consist of hospitals that are located in different states which have different licensure requirements affecting the organization and composition of the medical staff.

For example:•In one state it might be permissible for non-physician practitioners to be members of the medical staff, while in another the medical staff is limited to physicians.



Example:A multi-hospital system may consist of a mixture of hospitals, such as:

• short-term acute care hospitals• psychiatric hospitals• rehabilitation hospitals• children’s hospitals• long-term care hospitals

For this reason, the medical staff must assure that standard orders, policies, and procedures:1)Address the unique hospital circumstances2)Are approved by the nursing and pharmacy leadership at each separately certified hospital


03.00.15 Multiple-Hospital Systems: Policies of the Unified Medical Staff (NEW)

Standard:•The unified and integrated medical staff establishes and implements policies and procedures to ensure that the needs and concerns expressed by members of the medical staff, at each of its separately certified hospitals, regardless of practice or location, are given due consideration.


03.00.15 Multiple-Hospital Systems: Policies of the Unified Medical Staff (continued)

• The hospital’s unified medical staff must have written policies and procedures that address how it considers and addresses needs and concerns expressed by members who practice at the hospital.

Example: • Physicians practicing in a children’s hospital may have concerns about protocols for

medication administration that reflect specific pediatric patient concerns.


03.00.15 Multiple-Hospital Systems: Policies of the Unified Medical Staff (continued)

The medical staff has flexibility in establishing its written policies for addressing local concerns, but at a minimum must cover the following:1.A process by which members who practice at a hospital can raise their local concerns and needs with the unified medical staff’s leadership; 2.How members are informed of the process by which they can raise their local concerns and needs;

3.A process for referring the concerns and needs raised to the appropriate committee or other group within the medical staff for due consideration;

4.Documentation of the outcome of the medical staff’s review of the concerns and needs raised.


Additional CMS Final Rule Burden Reduction II Requirements

Additional HFAP Standards Revisions:

•23.00.05 Radiopharmaceuticals•24.00.06 Patient Nutritional Needs•24.00.07 Diet Orders•31.00.11 Orders for Outpatient Services


23.00.05 In-house Preparation of Radiopharmaceuticals (revised)

Deleted: •The previous requirement for DIRECT supervision.


23.00.05 In-house Preparation of Radiopharmaceuticals (revised)

Final Rule May 12, 2014•In-house preparation of radiopharmaceuticals is by, or under the supervision, of an appropriately trained registered pharmacist or doctor of medicine or osteopathic medicine. §482.53(b)(1)

Interpretation:•Standard does NOT require a registered pharmacist or MD/DO to be onsite by the physical presence in the hospital at all times, particularly during off-hours


23.00.05 In-house Preparation of Radiopharmaceuticals (continued)

The hospital shall have policies, approved by the medical staff, regarding the identification, qualification, and training of the professionals eligible to:

1.Prepare radiopharmaceuticals

2.Provide supervision of nuclear medicine personnel and the in-house preparation of radiopharmaceuticals.

3.Facility policies reflect evidence-based guidelines such as those recommended by the Society of Nuclear Medicine and Molecular Imaging (SNMMI).


24.00.06 Patient Nutritional Needs

Previous Requirement and Title: “Diet Orders” • Therapeutic diets must be prescribed by the practitioner or

practitioners responsible for the care of the patients. §482.28(b)(1)

Final Rule May 12, 2014•Revised Title: “Patient Nutritional Needs”

•New Requirement: “Individual patient nutritional needs must be met in accordance with recognized dietary practices.”


24.00.07 Diet Orders

Previous Requirement and Title: “Nutrition Care Process”

Final Rule May 12, 2014•Revised Title: “Diet Orders”

•New Requirement: All patient diets, including therapeutic diets, must be ordered by a practitioner responsible for the care of the patient, or by a qualified dietitian or qualified nutrition professional as authorized by the medical staff and in accordance with State law governing dietitians and nutrition professionals.



Definitions: •“Qualified” Dietitians. Certain states do not use the term “registered” and choose instead to use the term “licensed” dietitian.

For this reason, the “qualified” dietitian is used in these standards to mean the dietitian that has met the requirements of his or her respective State laws, regulations, and other appropriate professional standards.

•“Qualified” Nutrition Professionals. A “qualified” nutrition professional would refer to a “nutritionist”, “nutrition professional”, “certified clinical nutritionist” or “certified nutrition specialist” that has met the requirements of his or her respective State laws, regulations, and other appropriate professional standards.



Privileging of Dietitians and Nutrition Professionals: Hospitals, through their medical staff have the flexibility of privileging qualified Dietitians and qualified Nutrition Professionals -

• In accordance with respective State laws, regulations, and other appropriate professional standards.

• This does not require the granting of privileges, but allows the flexibility to do so if they so choose.



Surveyor Tip:1.Has the facility and medical staff granted privileges to qualified dietitians and or qualified nutrition professionals?

2.Are diet orders, including therapeutic diet orders, prescribed and authorized by:

a) A person responsible for the care of the patient, or

b) A qualified dietitian or nutrition professional, as authorized by the medical staff, in accordance with State law and scope of practice?


31.00.11 Orders for Outpatient Services (NEW)

Hospitals have the flexibility to determine whether or not they will allow a practitioner who is not a member of the medical staff to order outpatient services.

•The Medical Staff may permit practitioners who do not have privileges to order outpatient services

•However, if a hospital is unable or unwilling to verify the State scope of practice, licensure, and etc. for each practitioner, the hospital is not required to authorize the practitioner to order outpatient services.


31.00.11 Orders for Outpatient Services

Outpatient services must be ordered by a practitioner who:1.Is responsible for the care of the patient.

2.Is licensed in the State where he/she provides care to the patient.

3.Is acting within his or her scope of practice under State law.

4.Is authorized in accordance with State law and policies adopted by the medical staff, and approved by the governing body, to order the applicable outpatient services.


31.00.11 Orders for Outpatient Services (cont’d)

Medical Staff Bylaws address: •Whether to allow -

1. Non-physician practitioners, such as Physical Therapists, Occupational Therapists, Speech Language Pathologists, qualified Dietitians, and qualified nutrition professionals to write orders, consistent with State law and regulations.

2. Practitioners with a professional license from another State to write outpatient orders, consistent with State law and regulations.


Medical Staff Approved Policies

Medical Staff approved hospital policies outline:1.The procedure to implement when a patient presents with a referral or order for outpatient services.

2.Documentation expectations

3.For each ordering practitioner, the verification information to be collected prior to performing the test or procedure must include:


Medical Staff Approved Policies

Verification must determine if the practitioner is:

1.Licensed in the State where he/she provides care to patient

2.Acting within scope of practice per State law

3.Authorized per medical staff and governing body to order the applicable outpatient services.


January 30, 2015 Additional Updates

Services must be ordered by a qualified and licensed practitioner who is responsible for the care of the patient, acting within his or her scope of practice under State law, and who is authorized by the hospital’s medical staff, for the following:

1.Rehabilitation Services: HFAP Standard 26.01.07

2.Respiratory Therapy: HFAP Standard 17.00.07


Chapter 32 Swing Beds

CMS has re-numbered swing-bed requirements from §482.66 to §482.58. This impacts seven (7) HFAP Standards:

1)32.00.00 Special Requirements 2)32.00.01 Eligibility3)32.00.02 Bed Size4)32.00.03 Hospital Location5)32.00.04 Nursing Waiver6)32.00.05 No Termination of Swing Bed Approval7)32.00.06 Skilled Nursing Facility Services


CME

This webinar has been approved by the American Osteopathic Association Council on Continuing Medical

Education for 1.0 credit of AOA Category 2B CME.

A Certificate of Participation will be awarded through the American Osteopathic Information Association (AOIA) to those who successfully complete the Post-Test with score of 70% or

greater (allow 2-3 weeks to process).


Post Test

• Copy the URL listed below and paste into your browser to access the test on Testmoz.https://testmoz.com/438609

To access: Test name is “2014 CMS Final Rule”. • Type your 1st and last name where indicated • PASSWORD is “final rule” (lower case and space

between words)


https://testmoz.com/438609

QUESTIONS?

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