# Medicare and Medicaid Programs; Reform of Hospital and Critical Access Hospital Conditions of Participation

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A2012-11548

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** May 16, 2012
- **Citation:** 77 FR 29034

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 482 and 485
[CMS-3244-F]
RIN 0938-AQ89
Medicare and Medicaid Programs; Reform of Hospital and Critical Access Hospital Conditions of Participation

AGENCY:

Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services.

ACTION:

Final rule.

SUMMARY:

This final rule revises the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These changes are an integral part of our efforts to reduce procedural burdens on providers. This rule reflects the Centers for Medicare and Medicaid Services' (CMS) commitment to the general principles of the President's Executive Order 13563, released January 18, 2011, entitled “Improving Regulation and Regulatory Review.”

DATES:

These regulations are effective on July 16, 2012.

FOR FURTHER INFORMATION CONTACT:

CDR Scott Cooper, USPHS, (410) 786-9465; Jeannie Miller, (410) 786-3164; Lisa Parker, (410) 786-4665; Mary Collins, (410) 786-3189; Diane Corning, (410) 786-8486; and Sarah Fahrendorf, (410) 786-3112.

SUPPLEMENTARY INFORMATION:

Executive Summary for This Final Rule

A. Purpose

In Executive Order 13563, “Improving Regulations and Regulatory Review”, the President recognized the importance of a streamlined, effective, and efficient regulatory framework designed to promote economic growth, innovation, job-creation, and competitiveness. To achieve a more robust and effective regulatory framework, the President has directed each executive agency to establish a plan for ongoing retrospective review of existing significant regulations to identify those rules that can be eliminated as obsolete, unnecessary, burdensome, or counterproductive or that can be modified to be more effective, efficient, flexible, and streamlined. This final rule responds directly to the President's instructions in Executive Order 13563 by reducing outmoded or unnecessarily burdensome rules, and thereby increasing the ability of hospitals and CAHs to devote resources to providing high quality patient care.

B. Summary of the Major Provisions

Revisions To Allow Flexibility and Eliminate Burdensome Conditions of Participation (CoPs):
We have reduced burden to providers and suppliers by modifying, removing, or streamlining current regulations that we have identified as excessively burdensome.

•
Single governing body for multiple hospitals:
We will allow one governing body to oversee multiple hospitals in a multi-hospital system and have added a requirement for a member, or members, of the hospital's medical staff to be included on the governing body as a means of ensuring communication and coordination between a single governing body and the medical staffs of individual hospitals in the system.

•
Reporting of Restraint-Related Deaths:
We have replaced the requirement that hospitals must report deaths that occur while a patient is only in soft, 2-point wrist restraints with a requirement that hospitals must maintain a log (or other system) of all such deaths. This log must be made available to CMS immediately upon request. We have indicated that the log is internal to the hospital and that the name of the practitioner responsible for the care of the patient may be used in the log in lieu of the name of the attending physician if the patient was under the care of a non-physician practitioner and not a physician.

•
Role of other practitioners on the Medical Staff:
We have broadened the concept of “medical staff” and have allowed hospitals the flexibility to include other practitioners as eligible candidates for the medical staff with hospital privileges to practice in the hospital in accordance with State law. All practitioners will function under the rules of the medical staff. This change will clearly permit hospitals to allow other practitioners (e.g., APRNs, PAs, pharmacists) to perform all functions within their scope of practice. We have required that the medical staff must examine the credentials of all eligible candidates (as defined by the governing body) and then make recommendations for privileges and medical staff membership to the governing body.

•
Medical staff leadership:
We have allowed podiatrists to be responsible for the organization and conduct of the medical staff. This change will allow podiatrists to assume a new leadership role within hospitals, if hospitals so choose.

•
Nursing care plan:
We have allowed hospitals the options of having a stand-alone nursing care plan or a single interdisciplinary care plan that addresses nursing and other disciplines.

•
Administration of medications:
We have allowed hospitals to have an optional program for patient(s)/support person(s) on self-administration of appropriate medications. The program must address the safe and accurate administration of specified medications; ensure a process for medication security; address self-administration training and supervision; and document medication self-administration.

•
Administration of blood transfusions and intravenous medications:
We have eliminated the requirement for non-physician personnel to have special training in administering blood transfusions and intravenous medications and have revised the requirement to clarify that those who administer blood transfusions and intravenous medications do so in accordance with State law and approved medical staff policies and procedures. We believe that this clarification will make the requirement consistent with current standards of practice.

•
Orders by other practitioners:
We have allowed for drugs and biologicals to be prepared and administered on the orders of practitioners (other than a doctor), in accordance with hospital policy and State law, and have also allowed orders for drugs and biologicals to be documented and signed by practitioners (other than a doctor), in accordance with hospital policy and State law.

•
Standing Orders:
We have allowed hospitals the flexibility to use standing orders and have added a requirement for medical staff, nursing, and pharmacy to approve written and electronic standing orders, order sets, and protocols. We have required that orders and protocols must be based on nationally recognized and evidence-based guidelines and recommendations.

•
Verbal Orders:
We have eliminated the requirement for authentication of verbal orders within 48-hours and have deferred to applicable State law to establish authentication timeframes.

•
Authentication of Orders:
We have made permanent the previous temporary requirement that all orders, including verbal orders, must be dated, timed, and authenticated by either the ordering practitioner or another practitioner who is responsible for the care of the patient and who is authorized to write orders by hospital policy in accordance with State law.

•
Infection Control Log:
We have eliminated the obsolete requirement for a hospital to maintain an infection control log. Hospitals are already required to monitor infections and do so through various surveillance methods including electronic systems.

•
Outpatient services director:
We have removed the burdensome and outdated requirement for a single Director of Outpatient Services position that oversees all outpatient departments in a hospital. Hospitals already have separate directors for individual outpatient departments, so having a single overall Director position is duplicative and unnecessary.

•
Transplant Center Process Requirements:
We have eliminated a duplicative requirement for an organ recovery team that is working for the transplant center to conduct a “blood type and other vital data verification” before organ recovery when the recipient is known. The verification will continue to be completed at two other times in the transplant process.

•
CAH Provision of Services:
We have eliminated the burdensome requirement that CAHs must furnish diagnostic and therapeutic services, laboratory services, radiology services, and emergency procedures directly by CAH staff. This will allow CAHs to provide such services under arrangement.

Clarifying Changes:
We have clarified several requirements in the hospital and CAH CoPs to ensure that they are consistent with the statute as well as with other, more current CoP requirements.

•
Pharmaceutical Services:
We have made a technical change to replace the term “quality assurance program” with the more current term “quality assessment and performance improvement program.”

•
Infection Control:
We have made a technical change to replace the term “quality assurance program” with the more current term “quality assessment and performance improvement program.”

•
CAH Personnel Qualifications:
We have aligned the definition of “clinical nurse specialist” that is in the rule with the definition that is in the statute.

•
CAH Surgical Services:
We have clarified that “surgical services” are an optional service for CAHs.

Other Options Considered:
We discussed alternative options for revisions that we considered, but did not propose. In the proposed rule, we also solicited comments and suggestions from both stakeholders and the general public on additional reforms that would reduce burden on hospitals and CAHs. In this rule, we have included our responses to the comments received on those alternatives, as well as a summary of additional recommendations submitted by commenters.

C. Summary of Costs and Benefits

1. Overall Impact

The rule will reduce the total regulatory burden for hospitals and CAHs by nearly $940 million initially and by almost $5 billion over the next five years. Changes to the following CoPs accounted for the greatest potential savings in the final rule: § 482.22, Medical staff ($330 million); § 482.23, Nursing services ($110 million); § 482.24, Medical record services ($170 million); and § 482.54, Outpatient services ($300 million). Our estimates were based on input from stakeholders as well as on our own experience with hospitals.

The potential savings will be achieved through a number of significant regulatory changes. For example, changes to the Medical staff CoP will allow hospitals to broaden the concept of “medical staff” through the appointment of non-physician practitioners to the medical staff so that they may perform the duties for which they are qualified through training and education and as allowed within their State scope-of-practice laws. For hospitals that choose this option, significant savings might be achieved as non-physician practitioners will enable physicians to more effectively manage their time so that they may focus on the more medically complex patients. Changes to the Nursing services CoP will allow hospitals to have a stand-alone nursing care plan or a single interdisciplinary care plan that addresses nursing and other disciplines. Providing hospitals with the option for a single, interdisciplinary care plan for each patient that addresses nursing and other disciplines, will not only support and improve the coordination of patient care, it will also result in significant cost reductions and efficiencies.

The revisions will also allow hospitals much greater flexibility and freedom to determine the best ways to oversee and manage outpatients by removing the outdated requirement for a single Director of Outpatient Services. This simple, but necessary change to the Outpatient services CoP will bring hospitals both cost savings and more efficient ways to manage hospital resources. Finally, we will now allow CAHs to provide diagnostic and therapeutic services, laboratory services, radiology services, and emergency procedures under arrangement. For these small hospitals, this change will not only allow them to solve some of their pressing staffing problems in these service areas, it will allow them to increase access to these critical services for their patient populations.

While we feel confident that our estimates reflect a reasonable approach to hospital and CAH cost savings, much will depend on the future staffing and management decisions that individual hospitals and CAHs choose to make.

2. Section-by-Section Economic Impact Estimates for 2012

Section

Annual
savings
($M)

Five year
savings
($M)

Patient's Rights—Eliminate and replace burdensome reporting process for deaths involving only soft wrist restraints
482.13
$5.1
$25.5

Medical Staff—Flexibility to consider other practitioners as eligible candidates for the medical staff
482.22
330.0
1,650.0

Nursing Services—Eliminate requirement for nursing care plan when an interdisciplinary plan is already in place
482.23
110.0
550.0

Medical Record Services—Less burdensome process to authenticate verbal orders
482.24
80.0
400.0

Medical Record Services—Allow the use of pre-printed and electronic standing orders for patient orders
482.24
90.0
450.0

Infection Control—Eliminate log of incidents related to infections and communicable diseases
482.42
6.6
33.0

Outpatient Services—Allow one or more individuals to be responsible for the supervision of outpatient services
482.54
300.0
1,500.0

Transplant Organ recovery—Remove duplicative blood typing requirement
482.92
0.2
1.0

CAH Provision of Services—Eliminate the requirement that certain services be provided only by employees and not through contractual arrangements with entities such as community physicians, laboratories, or radiology services
485.635
15.8
79.0

Total

937.7
4,688.5

Acronyms

AHA American Hospital Association

AOA American Osteopathic Association

APRN Advanced Practice Registered Nurse

BBA Balanced Budget Act

CAH Critical Access Hospital

CCN CMS Certification Number

CDC Centers for Disease Control and Prevention

CfC Condition for Coverage

CoP Condition of Participation

CMS Centers for Medicare & Medicaid Services

CNS Certified Nurse Specialist

DNV Det Norske Veritas

EACH Essential Access Community Hospital

H&P History and Physical Examination

HAI Healthcare-Associated Infection

HFAP Healthcare Facilities Accreditation Program

HHS U.S. Department of Health and Human Services

IG Interpretive Guidelines

IOM Institute of Medicine

MRHFP Medicare Rural Hospital Flexibility Program

OBRA Omnibus Budget Reconciliation Act

OPO Organ Procurement Organization

PA Physician Assistant

RIA Regulatory Impact Analysis

RFA Regulatory Flexibility Act

RPCH Rural Primary Care Hospital

SBA Small Business Administration

SBREFA Small Business Regulatory Enforcement Fairness Act

SOM State Operations Manual

TJC The Joint Commission

UMRA Unfunded Mandates Reform Act

Table of Contents

This final rule is organized as follows:

I. Background

A. Introduction

B. Statutory and Regulatory Authority for Hospital CoPs

II. Provisions of the Proposed Rule and Response to Comments

A. Revisions To Allow Flexibility and Eliminate Burdensome CoPs

1. Governing Body (§ 482.12)

2. Patient's Rights (§ 482.13)

3. Medical Staff (§ 482.22)

4. Nursing Services (§ 482.23)

5. Medical Record Services (§ 482.24)

6. Infection Control (§ 482.42)

7. Outpatient Services (§ 482.54)

8. Transplant Center Process Requirements—Organ Recovery and Receipt (§ 482.92)

9. Definitions (§ 485.602) and Provision of Services (§ 485.635)

B. Clarifying Changes

10. Pharmaceutical Services (§ 482.25) and Infection Control (§ 482.42)

11. Personnel Qualifications (§ 485.604)

12. Surgical Services (§ 485.639)

C. Other Options Considered

III. Provisions of the Final Rule

IV. Collection of Information Requirements

V. Regulatory Impacts

I. Background

A. Introduction

This final rule reflects the Centers for Medicare and Medicaid Services' (CMS) commitment to the general principles of the President's Executive Order 13563, released January 18, 2011, entitled “Improving Regulation and Regulatory Review.” In this final rule we seek to reduce the regulatory burden placed on hospitals. We have identified a number of existing hospital Conditions of Participations (CoPs) that we believe could be reformed, simplified, or eliminated in order to reduce unnecessary burden and costs placed on hospitals and critical access hospitals (CAHs) under existing regulations. The January 2011 Executive Order directs agencies to select the least burdensome approaches, to minimize cumulative costs, to simplify and harmonize overlapping regulations, and to identify and consider flexible approaches that maintain freedom of choice for the American public. Executive Order 13563 also requires agencies to engage in a process of reviewing existing regulations to see if those rules make sense and continue to be justified. The provisions of this final rule are intended to meet the letter and spirit of Executive Order 13563, for reviewing existing regulations to see if those rules make sense and continue to be justified. They also meet the objectives of section 610 of the Regulatory Flexibility Act (RFA), which also requires agencies to review the impact of existing rules on small businesses or other small entities for possible reforms to reduce burden and costs.

B. Statutory and Regulatory Authority for Hospital CoPs

Sections 1861(e)(1) through (8) of the Social Security Act (the Act) provide that a hospital participating in the Medicare program must meet certain specified requirements. Section 1861(e)(9) of the Act specifies that a hospital also must meet such other requirements as the Secretary finds necessary in the interest of the health and safety of individuals furnished services in the institution. Under this authority, the Secretary has established regulatory requirements that a hospital must meet to participate in Medicare at 42 CFR Part 482, CoPs for Hospitals. Section 1905(a) of the Act provides that Medicaid payments from States may be applied to hospital services. Under regulations at 42 CFR 440.10(a)(3)(iii), 42 CFR 440.20(a)(3)(ii), and 42 CFR 440.140, hospitals are required to meet the Medicare CoPs in order to participate in Medicaid.

On May 26, 1993, CMS published a final rule in the
Federal Register
entitled “Medicare Program; Essential Access Community Hospitals (EACHs) and Rural Primary Care Hospitals (RPCHs)” (58 FR 30630) that implemented sections 6003(g) and 6116 of the Omnibus Budget Reconciliation Act (OBRA) of 1989 and section 4008(d) of OBRA 1990. That rule established requirements for the EACH and RPCH providers that participated in the seven-State demonstration program that was designed to improve access to hospital and other health services for rural residents.

Sections 1820 and 1861(mm) of the Act, as amended by section 4201 of the Balanced Budget Act (BBA) of 1997, replaced the EACH/RPCH program with the Medicare Rural Hospital Flexibility Program (MRHFP), under which a qualifying facility can be designated as a CAH. CAHs participating in the MRHFP must meet the conditions for designation specified in the statute and, under section 1820(c)(2)(B)(i)(I) of the Act, must meet the CoPs located at 42 CFR part 485, subpart F. Among such requirements, a CAH must be located in a rural area (or an area treated as rural) and must be located more than a 35-mile drive (or in the case of mountainous terrain or in areas with only secondary roads available, more than a 15-mile drive) from a hospital or another CAH unless otherwise designated as a “necessary provider” prior to January 1, 2006.

The CoPs are organized according to the types of services a hospital may offer, and include specific requirements for each hospital service or department. The purposes of these conditions are to protect patient health and safety and to ensure that quality care is furnished to all patients in Medicare-participating hospitals. In accordance with Section 1864 of the Act, State surveyors assess hospital compliance with the conditions as part of the process of determining whether a hospital qualifies for a provider agreement under Medicare. However, under section 1865 of the Act, hospitals can elect to be reviewed instead by private accreditation organizations approved by CMS as having standards and survey procedures that are at least equivalent to those used by CMS and State surveyors. CMS-approved hospital accreditation programs include those of The Joint Commission (TJC), the American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP), and Det Norske Veritas Healthcare (DNV) (See 42 CFR part 488, Survey and Certification Procedures.).

II. Provisions of the Proposed Rule and Response to Comments

On October 24, 2011, we published a proposed rule entitled “Reform of Hospital and Critical Access Hospital Conditions of Participation” (76 FR 65891). The proposed rule identified several priority areas in the CoPs for both hospitals (42 CFR Part 482) and CAHs (42 CFR Part 485) and set forth revisions intended to eliminate or significantly reduce those instances where the CoPs are duplicative, unnecessary, and/or burdensome.

We received approximately 1,729 public comments in response to the proposed rule. Many comments were supportive; however, there were some commenters that opposed the proposed provisions. Approximately 1,100 of the comments were part of a write-in campaign from anesthesiologists that supported what they described as CMS' upholding of physician supervision requirements, but objected to what the letters described as an effort to replace physicians with nurses.

In general, the comments can be classified into roughly three categories: comments from hospitals, comments from physicians, and those from non-physician practitioners. Commenters representing the hospital industry, as well as accrediting organizations, expressed overwhelming support for the proposals and agreement with our efforts to bring the CoPs in line with current medical practice, eliminate burdensome and obsolete requirements, and provide hospitals with operational flexibility. Physician groups mostly disagreed with staffing proposals, and expressed disagreement with what they viewed as the Agency's endorsement of the replacement of physicians with nurses and non-physician practitioners. While commenters representing non-physician practitioners expressed support for most of the proposals, they urged us to go further with changes that they believe would allow them to practice to the full extent allowed under their respective State laws and regulations. In the following section, we provide a brief summary of the proposed provisions, followed by responses to public comments received on each issue. For a detailed discussion of the proposals, see the October 24, 2011 proposed rule (76 FR 65891).

A. Revisions To Allow Flexibility and Eliminate Burdensome CoPs

1. Governing Body (§ 482.12)

We proposed to revise and clarify the governing body requirement to reflect current hospital organizational structure, whereby multi-hospital systems have integrated their governing body functions to oversee care in a more efficient and effective manner. Specifically, we proposed to revise the introductory text of § 482.12 to state that “There must be an effective governing body that is legally responsible for the conduct of the hospital.” We noted that we would retain the current provision that requires the persons legally responsible for the conduct of the hospital to carry out the functions specified in part 482 of our regulations that pertain to the governing body if the hospital does not have an organized governing body.

Comment:
Many commenters wrote in support of the CMS proposal to allow a single governing body for all hospitals within a multi-hospital system and they characterized the current requirement for a separate governing body for each hospital as redundant and obsolete. Several comments suggested the change would provide hospitals with greater flexibility and help them operate more efficiently and effectively. Others noted that the change would simplify governance and administrative processes. These commenters also suggested the change would enhance the continuity and consistency of policies and practices across all hospitals within a multi-hospital system. One commenter suggested the change might streamline the workflow for nurses. Many commenters also remarked that the proposal was appropriate given the more integrated organizational models adopted by many hospitals.

Some comments detailed the greater efficiencies and cost savings that would result, including savings in areas such as finance, human resources, information technology, and purchasing. Many commenters specifically remarked that the change would end the redundant and inefficient practice of multi-hospital systems' holding duplicative, separate meetings for each of the hospital boards.

Some comments stressed the advantages that a single governing body would have in terms of enhancing mutual accountability, interdependence and timely oversight. Commenters remarked that the single governing body structure could facilitate shared learning, promulgation of best practices and help hospitals standardize performance metrics and eliminate variances. Another commenter stated that its policy of allowing a single governing body for a multi-hospital system has not had an adverse impact on quality and safety.

Response:
We agree with the commenters that this change will positively affect hospitals. With the addition of a few changes pertaining to board membership, discussed below, we are finalizing this proposal for a single governing body. We will be finalizing the proposed language that refers to a hospital, generally, and removing the language referring to the hospital “as an institution.”

Comment:
Several commenters requested that CMS specify in regulatory text that, “hospital systems with more than one CMS Certification Number may have a single governing body.”

Response:
While we agree with the commenters' intent, and we recognize that the language suggested was excerpted from the preamble text of our proposed rule, we are not making this change in regulatory text. Rather, we will address this clarification in forthcoming sub-regulatory guidance. Our decision against using the term “CMS Certification Number” in the final regulatory text is merely a precaution intended to provide flexibility, should the terminology be changed.

Comment:
Several commenters requested that CMS take a stronger position in favor of hospitals' adoption of a single governing body for their multi-hospital systems. Specifically, these commenters asked CMS to expressly state that, “multi-hospital systems can be effectively led by a single governing body.” On the other hand, we received comments requesting that CMS expressly state that “multiple

hospitals cannot be effectively governed by a single governing body” and that “each hospital, including hospitals in a multi-hospital system, should have its own governing body.” Still other commenters asked CMS to reaffirm the important role of local sub-boards.

Response:
While we believe that multi-hospital systems might gain important efficiencies and achieve significant progress in quality programs under the governance of a single governing body, we also agree that local sub-boards might be a valuable resource in hospital governance. We believe there is an important and essential symbiotic relationship that should exist between a hospital's governing body and its medical staff. The dynamics of this relationship generate critical checks and balances that serve to promote and protect patient health and safety. We believe that the ongoing, timely communication between a governing body and its medical staff is essential to the successful coordination and advancement of patient care, regardless of whether the adopted governance model is one of a single governing body for all hospitals in a multi-hospital system, one of a single governing body with local sub-boards at each hospital in the system, or one of a separate governing body for each hospital. The intent of the proposed revision was to provide hospitals with some regulatory flexibility with regard to hospital governance and to acknowledge that alternative methods of governance exist that might prove as effective as the traditional methods currently required by the CoP. When practically applied in the “real world” of hospitals, each model of hospital governance has the potential to be flawed and dysfunctional just as each has the potential to be engaged and effective. We remind the commenters that the proposed revision to this requirement is an option that each multi-hospital system is free to choose or not to choose for itself. Because we have not seen sufficient evidence presented that would indicate that one model works more effectively than another, we do not believe that it would be appropriate for CMS to endorse one model of hospital governance over another.

Comment:
Several of the commenters who expressed a clear preference for a hospital-specific governing body asked CMS to require that, at minimum, a member of the medical staff serve on the governing body. The commenters suggested that CMS' proposal to allow for a single governing body within a multi-hospital system would diminish communication and coordination between the governing body and the medical staff as it presently takes place at the individual hospital level. Commenters stated that an effective governing body needs to have an informed understanding of the care coordination challenges at each member hospital and that this can only be achieved when the lines of communication are open between the governing body and the medical staff.

To counter the potential disruption of communication that may be caused by the proposal to allow multi-hospital governing bodies, commenters suggested that CMS require that a member of the medical staff serve on the governing body. Commenters added that such a model would further inform patient health and safety initiatives within the hospital.

Commenters also expressed concern that, even under the current requirements which require a governing body at each institution, hospital physicians are generally not well represented on hospital governing bodies. Commenters stressed the importance of physician input at the governing body level, particularly as they believe it is essential in the context of CMS' proposal to permit a single governing body for a multi-hospital system.

Response:
We agree with the commenters' suggestion, and we are modifying our final regulatory language to require that a hospital's governing body must include at least one medical staff member. We agree with the commenters that strong coordination between a hospital's governing body and medical staff is paramount to the delivery of quality care.

We note that these two, separate Conditions of Participation at § 482.12 (Governing body) and § 482.22 (Medical staff) have a long, overlapping, and interrelated history. In 1986, CMS discontinued a requirement for a joint committee to formalize liaison between the medical staff and the hospital's administration. At that time, we decided to leave decisions about liaison and coordination activities to internal hospital management (51 FR 22010, 22017, June 17, 1986). Because we are now making changes to the hospital's management structure by allowing a single governing body for multiple hospitals within a system, we believe that, in accordance with the comments we received on medical staff representation on the governing body, a formalized link between these interdependent entities is appropriate. While it may already be a requirement at some hospitals or simply a convention that others follow, we are not aware that this linked structure is the norm. We believe that adding the requirement for hospitals to have a medical staff member serve on the governing body will build in an important element of continuity and ensure regular communication between a hospital's governing body and its medical staff(s), particularly in light of our decision to permit a single governing body for hospitals in multi-hospital systems.

We also believe that requiring a hospital's governing body to include a medical staff member will directly address a widely voiced concern for stronger communication between a hospital governing body and the medical staffs of its member hospitals. In the case of a multi-hospital system with one governing body, we wish to clarify that we are not requiring that the governing body include a member of each separately certified hospital's medical staff, so long as at least one governing body member is a member of the medical staff of one system hospital. The governing body is free to select as many of its members from its medical staff(s) as it chooses. However, we would expect a multi-hospital system's single governing body to carefully consider the unique needs of the patient populations served by each of its member hospitals and their medical staffs when determining the number and composition of medical staff members to be appointed to the governing body. We recognize that physicians may be in a minority position on a hospital governing body even with this new requirement. That said, we believe that a physician who specifically represents medical staff members will hold some measure of enhanced standing within the governing body.

Comment:
We received numerous comments opposing our proposal for a single governing body. Many of these comments came from State and national physician associations as well as from a number of community hospitals. In particular, comments opposing a single governing body expressed concern that such a structure would further weaken governing boards' understanding of the daily operations and medical staff affairs of each hospital and thereby lead to a reduction in both the quality of care and patient safety protections. One community health network reported that it had seen “remote management” lead to waste of resources in the healthcare delivery system.

Some commenters expressed particular concern about the implications that a single governing body would have in a hospital system comprised of diverse institutions. For example, commenters stated that a

single hospital system can encompass remote, rural areas as well as urban and suburban areas, and may also include specialty hospitals, such as a pediatric hospital. The commenters suggested that, if hospital systems like these moved to governance by a single, overarching governing body, a single body would not be able to properly address the needs of each separate hospital, particularly the needs of any hospital especially different from others in the system.

Some commenters suggested that a single governing body would be more appropriate to large hospital systems with similar hospital members and that CMS should pare back its proposal by only making the single body option available in certain cases, to be limited by geography or specialty.

A number of commenters opposed our proposal on the grounds that it could prove problematic for non-profit hospitals in light of the new requirements for these hospitals that are included in section 9007(a) of the Affordable Care Act (ACA). The commenters pointed out that this section of ACA revised section 501(r) of the Internal Revenue Code (26 U.S.C.A. § 501(r)) to require a non-profit hospital to establish and maintain their tax-exempt status by, among other things, conducting a community health needs assessment every three years. They stated that a non-profit hospital would not be able to conduct this required assessment through its own governing body (which they see as “the natural convener of this activity in conjunction with the medical staff”) since they believe that our proposed governing body requirement, if finalized, may cause the hospital to lose its own governing body and be under the governance of a multi-hospital system's single governing body. The commenters also cited the requirements at § 501(c)(3) of the Internal Revenue Code regarding the tax-exempt status of non-profit hospitals and they stated that in order to meet the requirements of this section, a hospital must demonstrate that it provides a community benefit, which is defined by Internal Revenue Service (IRS) guidance as “based on part on whether a wide range of members of the community have a seat on the governance board.” The commenters stated that they believe “CMS' proposal to allow a single governing body for a multi-hospital system that is divorced from the very community it is meant to represent” would prevent these non-profit hospitals from meeting not only this IRS threshold for tax exemption, but also other State-specific requirements for tax-exempt status.

Response:
We appreciate the concerns of the commenters. We do not believe that a multi-hospital system's governing body can properly function without its gathering information and input from the administrative and medical staff of each member hospital, or from the local sub-boards if the system utilizes this model for hospital governance. We note that the regulations, as finalized here, are intended to provide multi-hospital systems with an option, but not a requirement, to use a single governing body. In those instances where a system believes that its interests are best served by using a single governing body, under the new CMS regulations, that system will have the flexibility to do so, just as another multi-hospital system will have the flexibility to continue following the current requirement for a separate governing body for each hospital in its system if it determines that course would best serve its interests.

Comment:
Several commenters asked CMS for clarity as to how a single governing body would operate within a multi-hospital system spanning different States.

Response:
We would expect multi-hospital systems to follow the laws, regulations, and local ordinances of the States in which each member hospital operates. A hospital system's adoption of a single governing body, as permitted under this revised federal regulation, would not in any way preempt any relevant State requirements. Hospitals must continue to comply with all applicable State and local laws.

Comment:
We also received a number of comments that asked how the new option for a single governing body would be implemented. One commenter asked how this would work for a multi-hospital system composed of more than one corporate entity. Another commenter asked whether survey decisions at each member hospital would be independent and whether this would impact the status of separately licensed, separately participating member hospitals in the system. Another commenter inquired about the integration of CAHs within a multi-hospital system, asking whether the proposal would allow for a system with both CAHs and hospitals to have one governing body or for systems with differing payment structures. Finally, we were asked to clarify between the CMS governance standard at § 482.12 and the requirements pertaining to co-located hospitals.

Response:
We note that permitting a single governing body for multiple hospitals in a system does not relieve each separately certified hospital from the obligation to separately demonstrate its compliance with all of the hospital CoPs. Each separately certified hospital will continue to be separately, independently assessed for its compliance, through either State Survey Agency or approved national accreditation program surveys. Several of the commenters' statements suggested that there may have been some confusion around this point.

We offer hospital facilities considerable flexibility regarding how and whether they choose to participate in the Medicare program. Based on the geographic and other institutional limitations set out in our “provider-based” regulation at § 413.65, which addresses provider-based status for hospital facilities in multiple locations, hospital governing bodies make business decisions about how they want to participate in Medicare, and they indicate on their Medicare enrollment application the choices they have made. It is not uncommon to find multiple hospital campuses with one owner located in the same general geographic area enrolled in Medicare as one hospital. It also is not uncommon to see a hospital system choosing to enroll its various facilities as separate hospitals, even where their geographic proximity would permit them to be enrolled as one hospital. We are aware that various factors enter into consideration when governing bodies make these business decisions. For example, some governing bodies prefer to enroll various campuses as separate hospitals, out of a concern that problems at one hospital's campus might jeopardize the Medicare participation of the other campuses if they were a multi-campus hospital covered under one Medicare provider agreement. In other cases, a governing body may see the benefits of integrating medical and nursing staff of multiple campuses into one integrated hospital. In still other cases, the deciding factor might be the implications for Medicare reimbursement of graduate medical education, the ease of adding satellite locations, etc. We defer to the governing bodies of hospitals to weigh the pertinent factors, the permissible options, and to make business decisions in their best interests when applying to participate in Medicare.

Our hospital certification decisions and issuance of a provider agreement and CMS Certification Number (CCN) follow from these business decisions by a hospital's governing body. We often certify as one “hospital” entities whose locations are identified on the application as one primary location and one or more “provider-based” satellite locations, and issue one provider agreement to that hospital. Once so

certified, the resulting “hospital” must then separately demonstrate its compliance with the hospital CoPs, independent of any other facility. While a system consisting of multiple, separately certified hospitals with a single governing body may promote similar, or even identical, compliance policies across its separately certified member hospitals, it must make clear which hospitals the policies apply to, and each separately certified hospital is accountable for implementing the applicable policies, including securing the policy approvals of its separate medical staff where required under the regulations. As an example, we could envision a hospital system with a single governing body establishing a uniform approach to developing hospital quality assessment and performance improvement (QAPI) programs. The system might even choose to measure some common quality indicators and pursue similar performance improvement activities and projects across its member hospitals. However, each member hospital would be responsible for maintaining and making available to us evidence of its hospital-specific QAPI program; presentation of only system-level information would not be acceptable.

With respect to the commenter's statement about separate licensure, we are unclear as to what clarification the commenter is seeking, but we note that § 413.65(d)(1) addresses State licensure requirements in order for facilities to be provider-based to a hospital's main campus. Those regulations provide for flexibility where separate licenses are required under State law.

A CAH must be separately evaluated for its compliance with the CAH CoPs found in 42 CFR Part 485, Subpart F. It would not be possible to evaluate the CAH's compliance as part of an evaluation of a hospital's compliance. However, this does not preclude a multi-hospital system's single governing body from also serving as the CAH's governing body, so long as the governing body clearly identifies the policies and decisions that are applicable to the CAH.

We recognize the importance of these inquiries and will address these in more detail in forthcoming interpretive guidance (IG) after the publication of this final rule.

2. Patient's Rights (§ 482.13)

Section 482.13(g) requires hospitals to report deaths associated with the use of seclusion or restraint. We proposed to modify the reporting requirements for hospitals when the circumstances of a patient's death involve only the use of soft two-point wrist restraints and no use of seclusion. At § 482.13(g)(2), we proposed that hospitals would be required to report to CMS the type of deaths described here (those involving soft two-point wrist restraints and no use of seclusion) by having hospital staff record the information about the death into a log or other system. At § 482.13(g)(4), we proposed that each entry in the record must be made no later than seven days after the date of death of the patient and that the record must include the patient's name, date of birth, date of death, attending physician, primary diagnosis(es), and medical record number. We also proposed that hospitals must make this information available to CMS in either written or electronic form immediately upon request.

For deaths involving all other types of restraints and all forms of seclusion, we noted that we would retain the current, more extensive death reporting requirements to CMS by telephone no later than the close of business on the next business day following knowledge of the patient's death. In addition to reporting the deaths by telephone, we proposed to revise § 482.13(g)(1) to provide additional reporting options, which would include the use of facsimile and electronic reporting.

Comment:
Many commenters favored the proposal to modify the reporting requirements for hospitals when the circumstances of a patient's death involve only the use of soft two-point wrist restraints. The favorable comments included those received from individual clinical professionals, hospitals and hospital associations, large healthcare systems, and several nursing groups. Several other commenters agreed with the revisions but recommended that the required logs be made publicly available.

Response:
We appreciate the comments supporting the proposed change and the comments that suggested we add additional requirements and oversight. Changing the current reporting requirement to one that requires hospital staff to enter information into a log or other system those patient deaths that involve the use of only soft two-point wrist restraints will reduce unnecessary burden without negatively impacting patient safety. We believe the change will represent a welcome reduction in burden for hospitals and their staff, particularly in settings with a large number of patients in intensive care.

We disagree with adding new requirements for hospitals to publicize the details from the log (or other system). The log will contain protected health information from the patient's medical record, such as the patient's name, date of birth, and primary diagnosis, all of which are protected by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule found at 45 CFR part 160 and part 164, subparts A and E. To further clarify that the method of reporting these deaths will be a hospital's maintenance of a log (or other system), to which a hospital must make an entry no later than seven days after an applicable patient's death, we are adding the word “internal” preceding “log or other system” in this final rule. We believe that this will clarify and emphasize that the log, or system that a hospital chooses to utilize for its reporting of these types of deaths, is one that will be maintained internally by the hospital and that CMS is not requiring public release of information about such deaths nor are we requiring hospitals to submit the information in the internal log (or other system) to CMS. However, in this final rule, hospitals will be required to make the information contained in the internal log or other system immediately available to CMS upon request as was initially proposed.

As discussed below, it is also important to remember that not all deaths of patients who die while in restraints, or shortly after their removal, are associated with the use of restraints. This is especially true in the context of soft two-point wrist restraints, which we note are often applied to acutely ill and medically unstable patients, prior to their eventual death, in order to prevent inadvertent patient removal of life-sustaining devices such as central lines and endotracheal tubes. The use of restraints in these cases is incidental to the patient's death and is not the cause of that death. Therefore, we do not believe that making public the information in the internal log (or other system) would contribute to ongoing quality improvement efforts.

Comment:
Some commenters wanted CMS to require hospitals to make the data available to protection and advocacy (P&A) agencies and to report the deaths to P&As as well as to CMS using a log or other system, as set forth at proposed § 482.13(g)(4). A few commenters called for CMS to require hospitals to provide P&As access to the hospitals' logs specifically in accordance with applicable federal and State laws. Some commenters further requested that CMS create an explicit reference in § 482.13 to the Developmental Disabilities Assistance and Bill of Rights Act of 2000, particularly with respect to the role of P&A agencies and their access to

information concerning the deaths of disabled individuals.

Many commenters urged CMS to continue working to prevent future deaths by improving the data collection and analysis of restraint- and seclusion-related deaths, including those reported using the log or other system.

Response:
We believe that data collection and analysis will be greatly improved by making changes to the way hospitals report data to CMS, and, at this time, we do not believe that expanding the requirements beyond what we have proposed would improve patient safety.

We are always looking for ways to improve and to increase the efficiency of communication that already occurs between CMS and P&As. We believe that the current, extensive reporting requirements may have impeded data collection and analysis. Adjusting the reporting requirements for a significant subset of restraint-related deaths, where only soft, two-point wrist restraints were used, will help to streamline data collection and sharpen our analytical focus.

Finally, we decline the commenters' request for an explicit reference to the Developmental Disabilities Assistance and Bill of Rights Act, as we believe such a reference is inappropriate in § 482.13. We note that the Conditions of Participation at § 482.11(a) already requires compliance with applicable Federal laws related to health and safety of patients, and we expect hospitals to ensure that any such requirements are met. However, as a practical matter, we must stress that CMS does not enforce other agencies' laws or rules, as would be the case with the above-referenced statute. CMS would only cite the facility for noncompliance with the aforementioned CoP at § 482.11 if the agency having jurisdiction makes a final determination that there was a violation.

Comment:
Some commenters requested that CMS expand the proposed reporting requirements at § 482.13(g)(4)(ii) by requiring hospitals to also record the length of time the patient was kept in the restraints as well as the reasons for and consequences of the restraint use.

Response:
We are requiring that hospitals document the patient's primary diagnoses along with the medical record number and other details. We believe that the data recorded in the internal logs will be sufficiently rich to conduct analysis of deaths where only soft, two-point wrist restraints were used. We do not believe that additional descriptions around the use of the restraints are necessary at this time. As we have stated elsewhere in this discussion and in our proposed rule, we are not aware of any research—or even any anecdotal information—suggesting a cause-and-effect relationship between the use of soft, two-point wrist restraints and patient deaths.

Comment:
Some commenters suggested flexibility in reporting the deaths involving soft two-point restraints. They recommended that we allow for fax and electronic reporting of soft two-point restraint deaths.

Response:
We proposed that hospitals must maintain a log or other system of deaths involving only soft two-point restraints that can be made available to CMS immediately upon request, and that the required information about these deaths must be entered into the log no later than seven days after the date of the death of the patient. The words “log or other system” at § 482.13(g)(2) were chosen to create flexibility, such that a hospital could adopt a written or electronic means of tracking these deaths. However, since we did not propose to require hospitals to submit these reports to CMS, except upon request, we wish to clarify that routine faxing and electronic reporting of the deaths at § 482.13(g)(2) directly to CMS is not necessary. Finally, we would note that the regulatory text now adds significant flexibility to the reporting options at § 482.13(g)(1) for all other deaths, permitting such reports to be made “by telephone, facsimile, or electronically, as determined by CMS.”

Comment:
One commenter recommended that we revise the overall requirement for death reporting in this rule. Two other commenters stated that the reporting requirements should be in accordance with State law. One commenter stated that reporting all deaths of patients who were restrained does not produce an accurate number of deaths caused by restraints. The commenter also noted that some patients may be near death when they are put into restraints and recommended that we clarify in the final rule that these individuals should not be included in the reporting requirement.

Response:
The requirements for reporting deaths of persons who were placed in restraints and/or seclusion were established by section 3207 of the Children's Health Act of 2000 (Pub. L. 106-310, codified as section 592 of the Public Health Service Act (42 U.S.C.A. 290ii-1). Eliminating all reporting for this class of restraint deaths and relying on State law would be contrary to federal law, which requires hospitals and many other categories of healthcare facilities to report all restraint-related deaths. As stated in the proposed rule, we believe that a regulation requiring hospital staff to record information regarding the patient death into a log or other system (and which is made available to CMS immediately upon request) is entirely appropriate for these types of patient deaths and that it will satisfy this requirement for reporting deaths involving soft two-point restraints.

Regarding which restraint deaths that should be reported, we agree that not all deaths that occur while a patient is restrained are proximately caused by the restraints themselves, and we have proposed these revisions so as to reflect this fact (revising the reporting requirements for soft two-point restraints). In proposing this revision, we looked at all death reporting that is required of Medicare-participating hospitals. For deaths involving all other types of restraints and all forms of seclusion, we are retaining the current reporting requirements. We proposed to add flexibility to those requirements by allowing the reports to be faxed or submitted electronically.

However, as we reviewed the public comments regarding these proposed revisions, it became apparent to us that our proposed language might still cause some confusion regarding which restraint deaths truly must be reported to CMS through the ongoing submission of data and which restraint deaths can be reported by recording the information in an internal log or other system that the hospital would make immediately available to CMS upon request. We came to the conclusion that the proposed regulatory language was still not sufficiently clear. We learned that, due to our use of the phrase “report to CMS” in proposed § 482.13(g)(2), many hospitals assumed that they would still be required to report the information through submission of data to CMS for those deaths related to soft, two-point wrist restraints. This was not our intention and does not achieve our purpose of reducing unnecessary regulatory burden. Therefore, in this final rule we have revised the proposed language to delete the phrase, “report to CMS,” and now will require that for those deaths related only to soft, two-point wrist restraints the hospital staff must record the information regarding the patient's death in an internal log or other system. We are finalizing as proposed the requirement that this information must be entered no later than seven days after the death and that the information in the internal log or other system must be made available to CMS immediately upon request in either written or

electronic form. We are also finalizing the requirement that each entry must document the patient's name, date of birth, date of death, name of attending physician or other licensed independent practitioner who is responsible for the care of the patient as specified under § 482.12(c), medical record number, and primary diagnosis(es).

Additionally, and in order to maintain consistency with these changes, we are revising the regulatory language proposed at § 482.13(g)(3). The language finalized here revises paragraph (g)(3) to contain two separate provisions and will now require that hospital staff must document in the patient's medical record the date and time the death was: (1) Reported to CMS for deaths described in paragraph (g)(1) or (2) recorded in the internal log or other system for deaths described in paragraph (g)(2).

Comment:
Some commenters recommended that we have a common reporting system. They stated that all deaths should be reported consistently, in the same manner and within the same timeframe, by the close of the following business day. They stated that having two separate reporting mechanisms would be confusing and would upset the existing, well-established uniform reporting protocols.

Some commenters quoted our responses in the 2006 final rule on Patient's Rights where we said “a uniform definition of restraint across care settings is a good approach, adds clarity, and avoids confusion * * * This definition renders unnecessary the otherwise impossible task of naming each device and practices that can inhibit a patient's movement” (71 FR 71388). These commenters suggested the CMS was disrupting this uniformity with the new revisions contained in this final rule.

Another commenter suggested that the new requirement for an internal log or other system would be more burdensome than the present requirements for reporting the death to CMS by telephone. The commenter wondered whether the new requirements would mean the maintenance of a separate log by an assigned individual to research the patient's medical records to obtain all the necessary information. Another commenter asked whether the new requirement for an internal log would include hospital databases where reports could be generated and sent to CMS.

Response:
We believe that the commenters have taken the responses to comments in the 2006 final rule out of the context in which they were discussed, that is, a uniform definition of restraint. For the sake of clarity, we note that we have not made a change to the definition of “restraint.” We still maintain that “a uniform definition of restraint across care settings” is the best approach and we are not changing that in this rule. What we are finalizing is a change to the reporting requirements and not to the definition of restraint. We have received extensive feedback from those who would be implementing the new reporting requirements, and this feedback has largely been favorable.

We believe the new requirements will relieve some burden on hospitals and their resources. We already expect hospitals to be tracking the details of deaths where the patient had been restrained by soft, two-point wrist restraints. Under the new requirements, this information will no longer need to be reported to CMS by telephone no later than the close of business the next business day following knowledge of the patient's death.

As suggested by one commenter, the requirements for the internal log or other system could be satisfied by the maintenance of a database where reports could quickly be generated if requested by CMS.

Comment:
One commenter asked why a death that could be related to soft wrist restraints calls for less accountability and why a hospital could take a week to report the death.

Response:
Hospitals remain accountable for the appropriate medical treatment of their patients and for all deaths that occur in their facilities. Not all circumstances involving restraints and associated deaths are the same. As discussed in the proposed rule, critically ill patients are often restrained in soft two-point restraints to prevent them from removing life-saving tubes and lines. And as we have stated elsewhere in this discussion and in our proposed rule, we are not aware of any research—or even any anecdotal information—suggesting a cause-and-effect relationship between the use of soft, two-point wrist restraints and patient deaths. Since such deaths are incidental to the use of these types of restraint, we believe that the revised reporting requirements that we are finalizing here are appropriate to the goal of ensuring hospital accountability for patient safety without continuing to impose undue regulatory burden in these instances.

Regarding the 7-day timeframe for documenting the entry about this type of patient death that we are finalizing in this rule, this modification affects only that segment of patient deaths where no seclusion is used and the only restraints used are soft, two-point wrist restraints. Even though this rule will allow for this timeframe, which we believe is entirely appropriate for those deaths where the use of restraints is incidental and not the cause of the patient's death, we do not expect a hospital to take the full seven days to document the entry on each of these deaths into its internal log or other system. Since the provision requires a hospital to provide the information in its internal log or other system to CMS immediately upon request, we would expect a hospital to enter the information as soon as possible in order to ensure that it has the most up-to-date information on these patient deaths in its system. However, to continue to require hospitals to report the deaths of these patients by the end of the next business day requires a significant amount of effort, and does not improve patient safety. Therefore, we are finalizing the 7-day timeframe requirement for documenting the entry in the log or other system as proposed.

Comment:
One commenter recommended that we require hospitals to retain the death reporting log for at least six years.

Response:
We disagree with requiring hospitals to retain the internal log for a minimum of six years, which, we note, is longer than the current requirements for medical records. However, State law may require longer periods of record retention for patient medical records or documents.

Comment:
Several commenters stated that having a time frame longer than 24 hours to submit information may be more effective at reducing burden than having two separate methods and timeframes. Still other commenters stated that having a longer timeframe to submit a report will not decrease burden.

Response:
We disagree with both comments. We believe that the proposed revisions to the death reporting requirement will provide flexibility to eliminate burden while ensuring patient safety. And we point out that the provision we are finalizing does not require the submission of information for the deaths related to soft, two-point wrist restraints only; the revised provision requires only the recording of information about these types of deaths in an internal log or other system.

Comment:
A commenter asked CMS to consider setting minimum timeframes for both the renewal of a restraint order and the monitoring of those patients in restraints who are non-violent or non-self destructive. The commenter suggested that undefined timeframes could exacerbate situations already

lacking in the practice of re-evaluations for continued restraint. The commenter also suggested that the absence of set timeframes contributes to problems concerning quality of care and patient autonomy and harms altruistic efforts, generally. The commenter stated that extended periods of restraint and seclusion pose a serious safety issue for non-violent or non-self-destructive patients, including those in vulnerable populations, and advocated for greater standardization in the guidelines.

Response:
These comments are outside the scope of this rule. While we thank the commenter for his or her opinions on this matter, we have not seen any evidence that such requirements for these types of orders improve patient safety. We believe that establishing arbitrary minimum timeframes for the renewal of orders for both restraints and subsequent monitoring of non-violent, non-self destructive patients could impede a hospital's flexibility in establishing its own policies and procedures for these orders, based on what the hospital knows would best meet the needs of its specific patient populations. Additionally, timeframe requirements could also increase provider burden in this area if the CMS timeframes are more restrictive than a hospital's current practice.

Comment:
One commenter requested that CMS make a clarifying statement regarding the requirements at § 482.13(e)(5) that would identify which practitioners may order restraint or seclusion. The commenter noted that the current requirements use the term “licensed independent practitioner” and that this has been interpreted by many to mean that a physician assistant may not order restraint and/or seclusion. The commenter expressed disagreement with these interpretations and suggested instead that, where permitted by State law, a physician could delegate the ordering of such measures to a physician assistant. The commenter requested that CMS provide a clarifying statement that (1) PAs are authorized to order restraint and seclusion and (2) are subject to training requirements.

Response:
The commenter is correct in pointing out that the current requirements use the term “licensed independent practitioner.” According to the State Operations Manual (SOM), the IGs for § 482.13(e)(5) state, “For the purpose of ordering restraint or seclusion, an LIP is any practitioner permitted by State law and hospital policy as having the authority to independently order restraints or seclusion for patients.” Therefore, if an individual PA was authorized by State law and hospital policy to independently order restraints or seclusion for patients, then that PA could do so within the hospital. However, since PAs have traditionally defined themselves as “physician-dependent” practitioners (as opposed to APRNs, who see themselves as independent practitioners), it is unlikely that a PA would be authorized by State law and hospital policy to “independently” order restraints or seclusions for patients as would be likely for licensed independent practitioners such as physicians, APRNs, and clinical psychologists. The supervising physician-PA team concept (and PA practice dependence on the supervising physician) is supported by the American Academy of Physician Assistants' description of the PA profession: “Physician assistants are health professionals licensed or, in the case of those employed by the federal government, credentialed to practice medicine with physician supervision” (American Academy of Physician Assistants. (2009-2010). Policy Manual. Alexandria, VA.). Moreover, a PA would not be allowed to order restraints or seclusion if the only authority to do so was delegated by a physician since this physician-delegated authority would establish that the PA was not independently authorized by State law and hospital policy, which we stated is a prerequisite for this type of order.

PAs (and RNs) are subject to the training requirements in this section, in addition to any special requirements specified by hospital policy associated with the one-hour face-to-face evaluation of a patient who is restrained or secluded for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others.

Comment:
One commenter inquired whether a “geri chair” is considered a restraint that would require reporting according to the revised requirements.

Response:
The only reporting change we proposed concerns those deaths where no seclusion has been used and the only restraints used were soft two-point wrist restraints, as set forth at § 482.13(g)(2). Per current IG for § 482.13(e)(1)(i)(A), found in the SOM (
http://cms.hhs.gov/manuals/Downloads/som107ap_a_hospitals.pdf
), a geri chair or a recliner could meet the definition of restraint only if the patient cannot easily remove the restraint appliance and get out of the chair on his or her own.

Comment:
One commenter inquired whether certain new types of restraints would be considered to fall within the “soft” two-point wrist restraint subset. The commenter described the material as made of nylon and a foam type of material, rather than the more commonly used cotton and wool materials, and that Velcro would be used to fasten them. The commenter also asked why CMS did not explicitly mention soft restraints which were applied to the ankles rather than a patient's wrists.

Response:
We would not expect hospitals to change their reporting method for deaths involving any restraints that could be described as hard and rigid, such as leather restraints.

CMS has specifically revised the reporting requirements for soft two-point restraints that are used only on the wrists and not those that were applied to a patient's ankles or elsewhere on the body.

We wish to stress that the restraints we are setting out for documenting in an internal log are those typically used in critical care settings, such as intensive care units, where such restraints are medically necessary. Soft two-point wrist restraints are commonly used to prevent patients from removing medically necessary devices and equipment such as central lines, endotracheal tubes, and nasogastric tubes.

Comment:
One commenter referenced a 2006 report, “Hospital Reporting of Deaths Related to Restraint and Seclusion,” published by the DHHS Office of Inspector General which found communications lapses among CMS, the Food and Drug Administration (FDA)—which monitors deaths associated with a medical device, Protection and Advocacy Agencies (P&As), and State survey agencies working on behalf of CMS. The commenter expressed concern about the OIG's findings, including its documenting of significant underreporting to CMS by hospitals of restraint- or seclusion-related deaths, as well as delays in reporting. The commenter inquired whether reporting delays had diminished since the report's publication.

Response:
We have limited data, but we believe that the current reporting requirements may actually exacerbate hospital underreporting or untimely reporting of deaths associated with restraint or seclusion. A review of data collected on deaths reported in May and in December of 2007 indicated that only 13.5 percent of all types of hospitals nationally had submitted any reports during those two months. Between 2008 and 2010 our Regional Offices entered into our survey and certification

database a sampling of reports, taking reports from two or three months in each of the years. We analyzed the data and found results consistent with a pattern of underreporting. At least for IPPS hospitals, which provide short-term acute care hospital services, and where soft wrist restraints are often used in critical care settings when patients are sedated and restrained for their own safety in order to preclude patient removal of items such as endotrachial tubes and central lines, we would have expected every such hospital to have had one or more cases per month of a patient who died while two-point soft wrist restraints were in use, or shortly thereafter. In fact, we received at least one report from only 41 percent of all IPPS and psychiatric hospitals during the sampled periods between 2008 and the present. Underreporting has proven to be an ongoing challenge under the current rule.

We would also note that, since the great majority of death reports that hospitals do submit involve two-point soft wrist restraints only, most of the reports submitted to us are reviewed and filed without any further action, since we do not believe in such cases that the use of the two-point soft wrist restraint contributed to the patient's death. In such cases we believe it would not be an effective use of our limited survey resources to conduct an on-site investigation as a follow-up to a death report where only soft two-point wrist restraints had been used and where there was no evidence that the death was caused by the restraints used. It is not surprising that many hospitals might fail to perceive a linkage between the use of a two-point soft wrist restraint and a patient's death, and therefore the need to report such deaths to us as a death associated with the use of restraint or seclusion. We believe the revised reporting requirement will enhance patient safety by only requiring the prompt submission to us of a more narrow range of patient deaths where the likelihood of causation by the use of restraint or seclusion is greater. We also believe we will be able to address underreporting more effectively under the revised rule. We also believe the new regulatory requirement will better focus hospitals' attention and corrective efforts in these riskier areas.

Comment:
A commenter remarked that, in proposing the changes to reporting by hospitals, CMS did not discuss the data from deaths related to other types of restraints or seclusion.

Response:
We agree with the commenter's apparent suggestion that more study may be necessary to evaluate the impact from other types of restraints or seclusion. As in the drafting of this proposal, CMS has pursued a conservative, cautious approach before finalizing the new requirements. In the proposal, we stated at the onset that, “CMS is not aware of any research—or even any anecdotal information—suggesting a cause-and-effect relationship between the use of soft, two-point wrist restraints and patient deaths.” As discussed above, in the context of the 2006 OIG report, “Hospital Reporting of Deaths Related to Restraint and Seclusion,” CMS has found this subset of restraint-related deaths to represent a substantial percentage of reported deaths to CMS. We do not believe there is a causal relationship between the use of soft two-point wrist restraints and patient deaths. Moreover, no public comments were submitted that provided any evidence or research to the contrary. We believe the new reporting requirements will allow CMS to focus more closely on data from deaths related to other types of restraints or seclusion where there is a greater likelihood of finding harm due to the restraints or seclusion.

Comment:
A commenter suggested that CMS should add language limiting its proposed change in the reporting requirements to the use of 2-point soft wrist restraints “in intensive and critical care units” and “to prevent patients from removing medically necessary devices and equipment restraints.”

Response:
We believe that the revised reporting requirements are appropriate and that the commenter's suggested additions could be problematic. We agree that soft two-point wrist restraints are generally used in intensive and critical care units and that they are used to prevent patients from removing medically necessary devices and equipment restraints. However, we would not expect hospitals to limit the use of such restraints to intensive and critical care units alone.

Comment:
A commenter suggested that CMS change its proposed language to be more inclusive of non-physician providers. The commenter recommended that § 482.13 (g)(4)(ii) be re-worded to read: Each entry must document the patient's name, date of birth, date of death, attending physician “or other clinician's” name, medical record number, and primary diagnoses.

Response:
We appreciate the commenter's suggestion. We agree that the proposed regulatory text does not take into consideration that patients who are not Medicare patients may be under the care of a non-physician practitioner or licensed independent practitioner, as that term is used here, if allowed under State law and hospital policy. Therefore, we are making a change to the regulatory text at § 482.13(g)(4)(ii) so that it will now read, “name of attending physician or other licensed independent practitioner who is responsible for the care of the patient as specified under § 481.12(c).” This will make the regulatory text here consistent with other provisions in this section. For Medicare patients, the requirements of § 482.12(c) will still apply.

3. Medical Staff (§ 482.22)

The CMS CoP on “Medical staff,” at § 482.22, concerns the organization and accountability of the hospital medical staff. We proposed three revisions to the Medical staff CoP.

First, we proposed to redesignate § 482.22(a)(2) as § 482.22(a)(5) and revise it by adding language to clarify that a hospital may grant privileges to both physicians and non-physicians to practice within their State's scope-of-practice law, regardless of whether they are also appointed to the hospital's medical staff. That is, technical membership in a hospital's medical staff would not be a prerequisite for a hospital's governing body to grant practice privileges to practitioners. Second, we also proposed to require that those physicians and non-physicians, that have been granted practice privileges within their scope of practice, but without appointment to the medical staff, are subject to the requirements contained within this section.

The third area in which we are proposing changes concerns the more direct responsibilities for the organization and accountability of the medical staff. These requirements are set forth at § 482.22(b)(3). Presently, the hospital may assign these management tasks to either an individual doctor of medicine or osteopathy or, when permitted by the State in which the hospital is located, a doctor of dental surgery or dental medicine. We proposed to allow a hospital the option of also assigning the leadership of the medical staff to a doctor of podiatric medicine when permitted by the State law of the State in which the hospital is located.

Comment:
Overall, the majority of comments were overwhelmingly supportive of the proposed changes to the Medical staff CoP at § 482.22(a) that would broaden the concept of “medical staff” to include other practitioners who are granted hospital privileges to practice in the hospital in accordance with State law, not only those who are actually appointed to sit on the medical staff. However, a significant number of

commenters, while supportive of the proposed changes, recommended that CMS go further with its revisions in this area. Specifically, they would like to see the requirements finalized with these additional revisions incorporated into the regulatory text:

• Medical staffs must be representative of all types of health professionals who have privileges, including Advanced Practice Registered Nurses (APRNs) and Certified Nurse Midwives/Certified Midwives (CNMs/CMs), and who provide services to a hospital's patients, and as they are authorized to provide services under State law and to the extent of their full scope of practice;

• Non-physician members of the medical staff must be accorded the same rights and protections as physician members, including full voting privileges, membership on committees, ability to appeal, and due process;

• The credentialing and privileging process and the selection process for medical staff membership must be transparent and follow established criteria;

• Each application for privileges must be completely reviewed and a determination made within a 60-day period; and

• The applicant must be notified of the determination in writing with an explanation of the determination.

One commenter asked for the “specific inclusion of registered dieticians as non-physician practitioners included and affected by the proposed regulation.” Another commenter voiced support for the proposal to allow hospitals to grant privileges to non-physicians, regardless of whether they are also appointed to the hospital's medical staff, but believed that expressly limiting the non-physician practitioner's scope of practice to what is allowed by the State in which the hospital is located (as we have proposed here) has the potential to greatly limit the value to be gained from that practitioner. The commenter stated further that it is well documented that more than half of the States have implemented regulations and restrictions that impede the full realization of the potential of APRNs, and that the quality of care by APRNs does not vary by State. The commenter affirmed that APRN care is of the same quality as that provided by physicians for the same services, and that there is no clinical reason for these variations in State scopes of practice. Finally, this commenter urged CMS to establish a standard that recognizes non-physician practitioners should be privileged to practice to the full extent of their professional education and capabilities by deleting the reference to State licensing in the proposed requirements. The commenter believes that this would be a way to break down unwarranted barriers to full utilization of APRNs and other non-physician practitioners in hospitals and that such a change in the final rule would be consistent with recommendations in
The Future of Nursing: Leading Change, Advancing Health
(Institute of Medicine, October 2010). It should be noted here that many of the other commenters who asked for CMS to go further in the revisions to the medical staff requirements also cited this IOM report. The IOM report includes a recommendation specific to CMS, which urges that we amend or clarify our requirements to ensure that advanced practice registered nurses are eligible for clinical privileges, admitting privileges, and membership on medical staff.

Conversely, we also received a significant number of comments from those who were adamantly opposed to the proposed changes. A majority of the dissenting opinions took the form of comments expressing serious concerns about allowing non-physician practitioners to obtain hospital privileges without becoming members of the medical staff. These commenters continued by stating that, “allowing some providers to circumvent medical staff oversight will detrimentally impact patient safety and quality afforded to Medicare beneficiaries and all patients.”

Many of the comments opposed to the proposed changes specifically focused on the proposal to allow physicians to be granted hospital practice privileges without requiring them to be appointed to the medical staff. The commenters stated that this proposed change would allow a hospital to exclude certain physicians from the medical staff, would effectively divide a hospital's physicians into two groups (those on the medical staff and those who are not), and would undermine what the commenters see as the medical staff's chief function: self-governance. The commenters maintain that appointment to the medical staff provides a physician with a voice in the governance of the medical staff and patient care, including the specific needs of that physician's patient population. Further, the commenters stated that the medical staff appointment “engenders a mutual responsibility for the activities and work of the medical staff—such as quality improvement—promoting a mutual objective to oversee and protect the health and safety of patients.” The commenters believe that this mutual objective of the medical staff is responsible for both professional standards and patient care.

These same commenters believe that the proposed changes would allow hospitals to circumvent the protections that the medical staff bylaws provide for physicians (for example, judicial enforcement of any procedural rights contained in the bylaws). The commenters state that the changes “could allow hospitals to avoid lawsuits by physicians who would otherwise be protected by the contractual relationship created by virtue of their appointment to the medical staff.” In other words, the commenters believe that the protections afforded to physicians by the medical staff bylaws are only available to those physicians who are appointed to the medical staff and that merely being granted clinical privileges to practice is not enough to guarantee these protections.

The commenters also voiced concern over what they saw in the proposed rule as an opportunity for hospitals to privilege physicians outside the authority of the medical staff. In their comments, they state that they are opposed to our proposal to allow a governing body to grant privileges in accordance with “hospital policies and procedures,” and not upon the recommendations of the medical staff “in accordance with medical staff bylaws, rules, and regulations,” as is currently required in the regulations. They believe that, if allowed, this could have a negative impact on peer review of physicians in hospitals. The commenters expressed concern that those who are privileged but not appointed to the medical staff would not have the same due process protections of peer review accorded to members of the medical staff members. Commenters questioned whether these physicians would then be subject to a hospital-driven review process that is dictated only by a hospital's administration without any medical staff input or with input from only a few hospital-selected medical staff members. They also are concerned that a privileging process that is allowed to be un-tethered from the medical staff could lead to various fraudulent practices by hospitals to which the commenters are opposed. Examples cited by commenters include the practice of “economic credentialing,” which the commenters described as the use of economic criteria (for example, potential to generate the most revenue for the hospital based on increased referrals) unrelated to the quality of care or professional competence to determine a practitioner's qualifications for privileges, and “horse trading,”

which they described as a practice whereby two or more hospitals informally agree on the privileging status of applicants based on the hospitals' mutual interests. The commenters requested clarification from CMS on all of these points and urged us to ensure that the proposed requirements would retain the authority of the medical staff, in accordance with its bylaws, rules, and regulations, to make medical staff appointment and privileging recommendations and that these changes would not hinder or obstruct medical staff peer review efforts. The commenters also encouraged CMS to look at the proposed regulatory language with regard to medical staff oversight of non-medical staff practitioners. They pointed out that there is no specific mention in the rule of the applicability of the medical staff bylaws and oversight to these types of practitioners, both physicians and non-physicians alike.

With regard to the discussion of non-physician practitioners and medical staff privileges in the proposed rule, these same commenters objected to what they saw as “CMS's explicit endorsement of the replacement of physicians with non-physician practitioners throughout the rule.” They commented that they believe that CMS's stated intent of the revisions to the medical staff CoP was to replace physicians with non-physicians, and this would be “contrary to the purpose of the CoPs, namely, to provide a safe hospital setting.” While the commenters recognized the value that non-physician practitioners provide to the healthcare team, they maintained that physicians are the practitioners who are best qualified to lead that team, particularly in a hospital setting where patients are treated for complex and critical illnesses and injuries. They further objected to what they saw in the proposed rule as CMS' explicit encouragement of the expansion of scope of practice laws by States. The commenters pointed out that this conflicts with the express regulatory language of the proposed rule, which defers to existing State scope of practice laws, and they cautioned that any expansion of these laws should be based on a review of the evidence and on the training and education of non-physician practitioners to determine if such expansions are truly in the best interests of patient health and safety.

Finally, the commenters urged CMS to consider their assertion that medical staff appointment and privileges are not “either/or” propositions. They pointed out that the American Medical Association (AMA) has long given its members guidance on medical staff categories of membership and cite the following examples: “Active,” “affiliate,” “administrative,” “call coverage,” “telemedicine,” and “temporary” (
Evolving Relationship between Hospitals and Medical Staff.
Brian M. Peters, Esq. (2001). AHLA Seminar Materials. Post & Schell, PC). They stated that while these categories “differ in their level of responsibility and oversight,” the categories do “share the comity of membership in the medical staff, which we believe engenders a shared accountability.” While the commenters noted that CMS mentions medical staff categories in the preamble, they point out that most medical staffs already employ categories and these are specified in the medical staff bylaws. Again, the commenters urged CMS to remove its proposed requirement at § 482.22 that would allow for the exclusion of some physicians from both the participation in, and the protections, of the medical staff.

Response:
We appreciate the support for the proposed changes. We also thank the commenters for their recommendations to make additional revisions to the medical staff requirements that would allow APRNs and other non-physician practitioners to practice to the full extent of their education and training. We have also noted the recommendations of the IOM report regarding our requirements and the eligibility of APRNs for hospital privileges and medical staff membership.

Upon review of our proposed medical staff requirements and the public comments received, we realized that we might not have achieved what we originally intended with these changes, that is, to provide hospitals with the flexibility they would need to explore new approaches to care giving by allowing them the ability to increase the numbers and types of practitioners who could be granted hospital privileges to treat and care for patients. As we proposed in these revisions, any regulatory limits on these privileges would be imposed by the State licensing and scope-of-practice laws of the State in which the hospital is located. We sought to relieve regulatory burden by clarifying and revising the current requirements so that hospitals would still be allowed to appoint non-physician practitioners to their medical staffs, but that medical staff membership would not be a prerequisite to being granted privileges in the hospital, regardless of whether a practitioner was a physician or a non-physician. Based on the public comments received, we are revising our proposed Medical staff requirements in this final rule to better address the many valid issues that were raised by both those who supported this section of the proposed rule and those who opposed it.

While we agree with the IOM report's recommendation that we amend our requirements to ensure that advanced practice registered nurses are eligible for hospital privileges and membership on medical staff, we respectfully disagree with the commenters' suggestions that we need to add additional requirements that would guarantee both non-physician practitioner representation on the medical staff as well as specific rights for those non-physician practitioners. In addition, we also disagree with the recommendations offered in the comments that we add very specific and highly prescriptive requirements pertaining to a hospital's credentialing and privileging process. The current requirements already provide for a transparent process based on established criteria. Although the current requirements provide a level of specific guidance to hospitals and their medical staffs regarding the privileging and medical staff appointment process, we do not believe that there is sufficient evidence to indicate that a hospital medical staff and, subsequently, patient health and safety would benefit from the addition of more rigid and prescriptive provisions, such as the commenters' specific recommendations to require a 60-day timeframe for a hospital to review and determine privileges for an individual practitioner applicant, or to require that the hospital notify the practitioner applicant in writing with an explanation of its determination.

We also disagree with the one commenter's recommendation that we specifically include registered dieticians in the category of non-physician practitioners affected by this rule. We assume that the commenter means that hospitals should be required to recognize registered dieticians as members of their medical staffs. We point out that the final rule does not specifically name any category of non-physician practitioner in the regulatory text. While we frequently mentioned APRNs and PAs in our discussions regarding the composition of the medical staff in both the proposed and final rules, we have done this only because these categories of non-physician practitioners have scopes of practice within the hospital setting that are often second only to physicians in terms of how broad those scopes of practice are. For this reason, these categories of non-physician practitioners seem the most logical and

appropriate choices of categories eligible for appointment to a hospital's medical staff. The current requirements and the revisions contained in this rule are written to allow a hospital's governing body the greatest flexibility in determining which categories of non-physician practitioners that it chooses to be eligible for appointment to the medical staff. Once the hospital's governing body determines which categories are eligible for appointment, the new requirements in this final rule will ensure that the medical staff examines the credentials of all eligible candidates and that it makes its recommendations for medical staff appointments to the governing body in accordance with State law, including scope-of-practice laws, and the medical staff bylaws, rules, and regulations. The rule is intended to encourage hospitals to be inclusive when they determine which categories of non-physician practitioners will be eligible for appointment to their medical staff. Under the new requirements, an individual hospital would be allowed to include registered dieticians as a category of non-physician practitioners eligible for medical staff appointment as long as their inclusion is in accordance with the laws of the State in which the hospital is located.

We also respectfully disagree with the comments recommending that we use our rulemaking authority to recognize non-physician practitioner professional education and capabilities in our requirements by removing our deference to State licensing and scope of practice laws. As we stated in a recent rule addressing credentialing and privileging and telemedicine services, “CMS recognizes that practitioner licensure laws and regulations have traditionally been, and continue to be, the provenance [sic] of individual States, and we are not seeking to pre-empt State authority in this matter. We believe that the proposed requirements regarding State licensure leave room for the laws that exist today as well as any changes to these laws that may occur in the future, including any increase in the number of States that decide to engage in compacts, privilege to practice or reciprocity agreements, endorsements, and other arrangements regarding practitioner licensure (76 FR 25557).” We would also note that generally, federal agencies do not issue rules preempting State law unless Congress explicitly or implicitly requires such preemption. Therefore, we will continue to defer to individual State practitioner licensing and scope of practice laws with regard to hospital privileges and medical staff appointments.

Finally, we do not agree with commenters' assertion that our goal is to “replace physicians with non-physicians.” Our overall intent in revising the proposed requirements in this final rule continues to be what we initially expressed in the proposed rule, namely, to provide the flexibility that hospitals need under federal law to maximize their medical staff opportunities for all practitioners, particularly for non-physician practitioners, but within the regulatory boundaries of their State licensing and scope-of-practice laws. We believe the greater the flexibility that hospitals, medical staffs, and individual physicians have to enlist the services of non-physician practitioners to carry out the patient care duties for which they are trained and licensed, the better the quality of care will be for patients. Therefore, in this final rule, we are both modifying the proposed changes to the Medical staff requirements as well as revising portions of the current requirements of this section in the following manner:

• Removing the proposed concept of physicians and other practitioners being privileged to practice without appointment to the medical staff;

• Removing the proposed regulatory language that the granting of privileges is done in accordance with “hospital policies and procedures;”

• Aligning the new regulatory language at § 482.22 (a) with that currently found in the Governing body CoP (§ 482.12(a)(1)) regarding the governing body requirement to determine, in accordance with State law, the categories of practitioners who are eligible for medical staff appointment;

• Revising existing § 482.22(a)(2) to require the medical staff to examine the credentials of all eligible candidates and make recommendations for medical staff membership to the governing body in accordance with State law, including scope of practice laws, and with medical staff bylaws, rules, and regulations; and

• Revising existing § 482.22(a)(2) to require that a candidate recommended by the medical staff and appointed by the governing body be subject to all medical staff bylaws, rules, and regulations in addition to the requirements in this section.

We believe that these changes would not only satisfy the recommendations of the IOM report, but would also directly address the issues raised by commenters who opposed our proposed revisions. The regulatory language that we are finalizing here emphasizes the collaborative nature that must exist between the medical staff and the governing body of a hospital. It is a system of checks and balances between the governing body and the medical staff (and, to a certain degree, also between an individual practitioner and the hospital's medical staff and governing body). Each has its own areas of authority. The medical staff has oversight of all practitioners practicing as part of the medical staff through processes such as peer review and re-privileging. The governing body has the authority to establish the categories of practitioners (regardless of the terms used to describe those categories) who are eligible for privileges and medical staff appointment, but must rely on the medical staff to apply the criteria for privileging and appointment to those eligible candidates and to make their recommendations before the governing body makes a final decision to appoint or not appoint a practitioner to the medical staff. With the changes contained in this final rule, we are ensuring that these areas of authority remain intact.

The changes also leave room for a hospital or a governing body, after considering the recommendations of its medical staff, to appoint non-physician practitioners to the medical staff and to grant them privileges that are in alignment with their professional education and training to the full extent allowed under State licensing and scope-of-practice laws. We encourage medical staff and hospitals to take advantage of the expertise and skills of these non-physician practitioners when making recommendations and appointments to the medical staff. We agree with commenters that an appointment to the medical staff engenders a sense of mutual responsibility for the activities and work of the medical staff for physicians; however, we believe that these sentiments are also engaged when non-physician practitioners are appointed members of a hospital's medical staff. We encourage physicians and hospitals to enlist qualified non-physician practitioners to fully assist them in taking on the work of overseeing and protecting the health and safety of patients. This applies not only to the “work” of the medical staff—such as quality innovation and improvement, best practices application, and establishment of professional standards—but also to the everyday duties of caring for patients. As many of the commenters expressed, we also believe that an interdisciplinary team

approach to patient care is the best model for patients. However, we also agree that physicians, owing to their training and expertise, must be the leaders in overall care delivery for hospital patients. The changes that we are making to the requirements clarify and affirm these precepts. However, this should not be construed to limit the authority of a physician to delegate tasks to other qualified healthcare personnel or to limit the authority of a non-physician practitioner to be responsible for the care of an individual patient, or patients, as allowed in accordance with State laws, medical staff bylaws, and hospital policies.

Comment:
A significant number of comments were supportive of the proposed changes to the Medical staff CoP at § 482.22(b) that would expand the list of physicians who would be eligible to assume direct leadership responsibilities for the organization and accountability of the medical staff to include doctors of podiatric medicine (DPMs), when permitted by the State law of the State in which the hospital is located. This proposal would permit a DPM to fill this role, in addition to the categories of physicians that are allowed to assume this leadership position under the current requirements: an individual doctor of medicine or osteopathy or, when permitted by the State law of the State in which the hospital is located, a doctor of dental surgery or dental medicine. Many of these commenters cited the similarities in education, training, and experience that DPMs share with their allopathic and osteopathic colleagues as reasons for their support of this proposed change to the medical staff leadership requirements.

One commenter expressed support for the proposal to include DPMs as eligible leaders of the medical staff and recommended that CMS extend this provision to other non-physician practitioners. However, the commenter pointed out that the non-physician practitioners eligible to fill the medical staff leadership role in a hospital should be limited to APRNs. The commenter recommended that PAs should be excluded from eligibility for the medical staff leadership role in hospitals because they believe that PAs lack the level of education, training, and experience that APRNs possess.

There were also a significant number of commenters who opposed this proposed change. These commenters expressed concern over the precedent that this sets and maintained that practitioners who are not medical doctors or doctors of osteopathy should not be authorized to hold leadership positions on the medical staff of a hospital. The commenters also believe that in many hospitals, “a `Chief Medical Officer,' someone hired by the hospital who is not a physician, is appointed to serve in a leadership position that would otherwise be held by a member of the medical staff.” They stated that they believe our proposal to include DPMs could result in more of this type of activity and asked that we carefully consider the intended results of our proposed change to this provision.

Response:
We appreciate the comments that supported the proposed change. We also thank the commenters who expressed an opinion that was in opposition to our proposed revisions to this provision of the Medical Staff CoP.

However, we do not see a connection between our proposal to include DPMs as potential candidates for medical staff leadership in any hospital where they are members of the medical staff and the alleged practice to which the commenters referred. Nor do we believe that the commenters opposing this proposal have provided any evidence that would lead us to believe that DPMs are not qualified to lead the medical staff of a hospital and that to do so would place the health and safety of patients at risk. Section 1861(r) of the Act includes DPMs under the definition of physician and nothing in the statute precludes a DPM from leading a medical staff if the medical staff selects one for this position and the governing body approves of the medical staff's selection. As we stated in the preamble of the proposed rule, we believe that DPMs possess the education, training, and experience that makes them qualified to hold such a leadership position if the hospital and its medical staff chooses to exercise this option. In addition, while we recognize the education, training, and experience that non-physician practitioners bring to the care of hospital patients, we disagree with the commenter who recommended that APRNs be included in the list of eligible medical staff leaders, since this category of practitioner does not meet the statutory definition of physician. However, as we have noted above, we continue to encourage and support the inclusion of APRNs, PAs, and other non-physician practitioners on hospital medical staffs, as we believe they can assist physicians with the oversight and improvement of patient care. Therefore, we are finalizing this requirement as proposed.

4. Nursing Services (§ 482.23)

We proposed to revise the hospital nursing service requirements at § 482.23 (b)(4), “Nursing services,” which currently requires a hospital to ensure that the nursing staff develop, and keep current, a nursing care plan for each patient. We proposed that for those hospitals that use an interdisciplinary plan of care in providing patient care, the care plan for nursing services may be developed and kept current as part of the hospital's overall interdisciplinary care plan.

We proposed to revise the current Nursing services CoP at § 482.23(c) by adding new provisions that would allow for drugs and biologicals to be prepared and administered on the orders of practitioners other than those specified under § 482.12(c). We also proposed further revision to § 482.23(c) to add a new provision allowing orders for drugs and biologicals to be documented and signed by practitioners other than those specified under § 482.12(c). We proposed to allow for these two revisions only if such practitioners were acting in accordance with State law, including scope-of-practice laws, and only if the hospital had granted them privileges to do so.

Within this section of the Nursing services CoP, we also proposed changes that would allow hospitals to use standing orders. At § 482.23(c)(1)(ii), we proposed to allow for the preparation and administration of drugs and biologicals on the orders contained within pre-printed and electronic standing orders, order sets, and protocols for patient orders, but only if such orders meet the requirements of § 482.24(c)(3), as discussed below.

We also proposed to eliminate the requirement, currently at § 482.23(c)(3), that non-physicians must have special training in administering blood transfusions and intravenous medications.

At § 482.23(c)(4) we proposed that those who administer blood transfusions and intravenous medications do so in accordance with State law and approved medical staff policies and procedures. We proposed to retain § 482.23(c)(4) and redesignate it at § 482.23(c)(5), without any content change.

We also proposed additional revisions at § 482.23(c)(6) that would allow hospitals the flexibility to develop and implement policies and procedures for a patient and his or her caregivers/support persons to self-administer specific medications (non-controlled drugs and biologicals). We proposed requirements that a hospital would have to meet if it chooses to implement such a policy.

Nursing Services 482.23(b)(4)—Use of an Interdisciplinary Plan of Care

Comment:
A majority of commenters supported the revisions to this provision that would allow for the incorporation of the nursing care plan into the larger interdisciplinary care plan. A few commenters asked that we clarify what would be required regarding documentation of the interdisciplinary plan.

Several commenters recommended that CMS add a requirement that all hospitals implement a hospital-wide staffing plan that would establish an appropriate number of registered nurses on each unit to meet the needs of the patients and the expectations of those units. They stated that the plan should take into account factors present on each unit during each shift, such as: the number of patients and the level and variability of intensity of care; the level of education, training, and experience of RNs providing direct patient care; and non-patient care-related duties that nurses oversee.

Response:
We appreciate the comments supporting the rule as well as the suggestions for additional staffing requirements. The required documentation for the interdisciplinary care plan should follow the current documentation policies that hospitals are using to document the services provided by other disciplines to patients, such as services provided by physical therapists, occupational therapists, speech-language pathologists, and others. Documentation should follow the standards of practice for those disciplines in addition to any specific requirements that a hospital might want to establish. The documentation must also comply with the requirements of the CoP at § 482.24, Medical records services.

Regarding the recommendations for additional staffing requirements, the regulation already requires the hospital to have adequate numbers of nurses to provide nursing care as needed, and makes it the responsibility of the director of nursing services to determine the types and number of nursing personnel and staff necessary to provide nursing care for all areas of the hospital. Therefore, we do not see the need to require any additional or more prescriptive regulations to address the nursing issues expressed by the commenters.

Comment:
One commenter stated that the Nursing Care Plan should not be merged with the service notes and treatment plans of other professionals for reasons of patient safety, transparency, authority and accountability to professional practice standards. The commenter believes that entries made by an RN should not be replaced with entries made by other disciplines. Another commenter stated that the interdisciplinary care plan should be the responsibility of nurses, who are better trained and positioned to ensure that the plan is patient-centered and well-coordinated between disciplines. Another commenter recommended that we change 482.23(b)(4) to ensure that the nursing staff provides evidence in the medical record that the unique and changing needs of the patient are considered and met. They stated that this medical record documentation can be part of a nursing care plan, an interdisciplinary care plan, or a clinical pathway, or through other methods approved by the hospital.

Response:
While we understand to a certain degree the concerns expressed regarding the care plan, we do not understand the one commenter's concern that nursing entries would be replaced by entries made by other disciplines. The provision does not require a hospital to replace its nursing care plan with an interdisciplinary care plan nor does it require (or even permit) nursing entries to be replaced by entries made by another discipline. We proposed that the nursing care plan be permitted to be part of an interdisciplinary care plan based on hospital policy. The hospital is responsible for ensuring that the nursing staff develops and keeps current a nursing care plan for each patient and the hospital can determine if the nursing care plan is a part of a larger, coordinated interdisciplinary care plan. As proposed, the requirement was an option intended to provide flexibility for hospitals that believed patient care plans should reflect coordination of care by the various disciplines providing services to patients.

Additionally, we disagree with changing the regulation by adding language that requires nurses to provide evidence in the medical records regarding how the needs of patients are met. In addition to the current requirement that an RN must supervise the nursing staff and evaluate the nursing care for each patient, the hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient even if it is part of a larger, coordinated interdisciplinary care plan. We believe that the current requirements adequately ensure that the unique needs of each patient are addressed.

Comment:
A few commenters recommended that we require hospitals to conduct, no less than annually, an evaluation of the staffing plans based upon an assessment of patient outcome data that is nursing sensitive and that hospital staffing plans be made available to the public. The commenters also recommended that a perioperative RN should be present in each operating room acting as a circulator throughout the duration of each surgical procedure.

Response:
We agree with the commenters that hospitals should evaluate their nurse staffing plans and ensure that the appropriate staff is available to provide quality health care to all patients. We believe that it is implicit in the requirement for the director of nursing to determine the types and numbers of nursing personnel necessary that the director of nursing would periodically re-evaluate staffing plans to ensure that the nursing care needs of patients are met.

Comment:
One commenter recommended that the interdisciplinary team should include the patient/patient advocate/power of attorney in addition to the traditional healthcare team of providers to participate in the plan of care.

Response:
The regulations at 42 CFR 482.13 establish the right of the patient, or the patient's representative, as applicable, to participate in the development and implementation of his or her plan of care and to be informed of the patient's healthcare status and to make informed decisions about his or her care. We believe it would be redundant to also include these rights in the regulatory text related to the nursing or interdisciplinary plan of care.

Nursing Services 482.23(c)(1)(i)—Drugs and Biologicals May Be Prepared and Administered on the Orders of Other Practitioners (in Accordance With State Law and Scope of Practice Laws)

Nursing Services 482.23(c)(1)(ii)—Drugs and Biologicals May Be Prepared and Administered on the Orders Contained Within Pre-Printed and Electronic Standing Orders, Order Sets, and Protocols for Patient Orders

Nursing Services 482.23(c)(3)(iii)—Orders for Drugs and Biological May Be Documented and Signed by Other Practitioners

Comment:
A significant number of commenters supported the proposed changes that would allow drugs and biologicals to be prepared and administered on the orders of other practitioners not specified under § 482.12(c) if the practitioners are acting in accordance with State law, including scope-of-practice laws, and if the

hospital has granted them the privileges to write orders.

Commenters were also very supportive of the inclusion and allowance for standing orders in the proposed revisions to the Nursing services requirements. We also received comments specifically supporting the use of standing orders to encourage immunizations, notwithstanding the regulations at § 482.23(c)(3), which allow for nurse-initiated administration of influenza and pneumococcal polysaccharide vaccines per physician-approved hospital policy after an assessment of contraindications. Commenters were enthusiastic about the positive effect that they believed the use of standing orders would have for the broader patient population in general and for hospital infection control efforts specifically in terms of a possible increase in the immunization rate.

Similarly, there was extensive support for the proposed revisions to allow for “other practitioners not specified under § 482.12(c)” to document and sign orders for drugs and biologicals, provided that such practitioners meet the provisions discussed above. Many commenters stated that they believe the changes will allow other qualified practitioners the flexibility to address the immediate needs of patients without delay and that it will increase efficiency and the quality of patient care at the same time. One commenter stated that the changes will “lessen the impact of the current shortage of general practitioner MDs, thereby allowing patients fuller access to care” by allowing other qualified practitioners the “ability to write orders and to practice to the full extent of their scope of practice and State law.”

Response:
We thank the commenters for their support of the proposed revisions to these provisions in the Nursing services CoP. We agree that the changes will help to eliminate unnecessary delays in treatment, improve access to care for hospital patients, and improve immunization rates for the broader patient population. We appreciate the support from commenters on the proposed standing orders provisions contained in this section and will discuss the comments on these changes in the Medical record services section that follows this section. However, we should point out that the changes finalized here and in the Medical record services section regarding the use of orders (including pre-printed and electronic standing orders, orders sets, and protocols) do not allow for the use of nurse-initiated orders (beyond, or in addition to, those currently allowed for influenza and pneumococcal vaccination) without an authenticated physician or practitioner order. We should also note that while the provisions finalized here will allow for a qualified non-physician practitioner to write orders and to practice to the full extent of his or her State scope of practice, some insurers, including Medicare, may only pay for the services ordered by a physician or for the services ordered incident to a physician's services.

Comment:
Several commenters took exception to the fact that the proposed language in these provisions does not defer to medical staff bylaws, rules, and regulations. Other commenters also expressed serious concerns about what they categorized as “the proposal to expand the types of practitioners who are able to administer drugs and biolog

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2012-11548. Public record. Not legal advice.