Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Fire Safety Requirements for Certain Dialysis Facilities; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 403, 416, 418, 441, 460, 482, 483, 484, 485, 486, 488, 491, and 494

[CMS-3346-F; CMS-3334-F; CMS-3295-F]

RIN 0938-AT23

Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Fire Safety Requirements for Certain Dialysis Facilities; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care

AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Final rule.

SUMMARY:

This final rule reforms Medicare regulations that are identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. This final rule also increases the ability of health care professionals to devote resources to improving patient care by eliminating or reducing requirements that impede quality patient care or that divert resources away from furnishing high quality patient care. Additionally, this rule updates fire safety standards for Medicare and Medicaid participating End-Stage Renal Disease (ESRD) facilities by adopting the 2012 edition of the Life Safety Code and the 2012 edition of the Health Care Facilities Code. Finally, this final rule updates the requirements that hospitals and Critical Access Hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These requirements are intended to conform to current standards of practice and support improvements in quality of care, reduce barriers to care, and reduce some issues that may exacerbate workforce shortage concerns.

DATES:

Effective date:

These regulations are effective on November 29, 2019. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of November 29, 2019.

Implementation dates:

The regulations at § 485.641 regarding Quality Assessment and Performance Improvement Programs (QAPI) in critical access hospitals (CAHs) must be implemented by March 30, 2021.

The regulations at § 482.42(b) and § 485.640(b) regarding hospital and critical access hospital (CAH) antibiotic stewardship programs must be implemented by March 30, 2020.

FOR FURTHER INFORMATION CONTACT:

For issues related to Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction, contact Kristin Shifflett, (410) 786-4133.

For issues related to Fire Safety Requirements for Certain Dialysis Facilities, contact Kristin Shifflett, (410) 786-4133.

For issues related to the Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care, contact CAPT Scott Cooper, USPHS, (410) 786-9465, Mary Collins, (410) 786-3189, Alpha-Banu Wilson, (410) 786-8687, or Kianna Banks, (410) 786-3498.

SUPPLEMENTARY INFORMATION:

We note that this rule finalizes provisions that were proposed in three separate proposed rules that were published in the

Federal Register

on separate dates. Specifically, we are finalizing the provisions of the following proposed rules, discussed as follows:

• “Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction,” published September 20, 2018 (83 FR 47686);

• “Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care,” published June 16, 2016 (81 FR 39448); and

• “Fire Safety Requirements for Certain Dialysis Facilities,” published November, 4, 2016 (81 FR 76899)

To assist readers in referencing sections contained in this preamble, we are providing a table of contents.

Table of Contents

I. Final Rule: Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction

A. Executive Summary and Background

1. Purpose

2. Summary of Major Provisions

3. Summary of Costs and Benefits for Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction

B. Provisions of the Proposed Rule and Analysis and Response to Public Comments

1. Religious Nonmedical Health Care Institutions (RNHCIs)—Discharge Planning

2. Ambulatory Surgical Centers

3. Hospice

4. Hospitals

5. Transplant Centers

6. Home Health Agencies

7. Comprehensive Outpatient Rehabilitation Facility (CORF)—Utilization Review Plan

8. Critical Access Hospitals

9. Community Mental Health Center

10. Portable X-Ray Services

11. Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)

12. Emergency Preparedness for Providers and Suppliers

13. Technical Corrections

14. Waiver of Proposed Rulemaking

C. Collection of Information Requirements

II. Final Rule: Fire Safety Requirements for Certain Dialysis Facilities

A. Background

B. Provisions of the Proposed Rule and Analysis and Response to Public Comments

1. 2012 Edition of the Life Safety Code

2. Incorporation by Reference

3. Ambulatory Health Care Occupancies

4. 2012 Edition of the Health Care Facilities Code

5. Technical Corrections

C. Collection of Information Requirements

III. Final Rule: Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care

A. Background

B. Provisions of the Proposed Rule and Analysis and Response to Public Comments for Hospitals

1. General Comments

2. Implementation Timeframe

3. Non-Discrimination

4. Licensed Independent Practitioner

5. Quality Assessment and Performance Improvement (QAPI) Program

6. Nursing Services

7. Medical Record Services

8. Infection Prevention and Control and Antibiotic Stewardship Programs

9. Technical Corrections

C. Provisions of the Proposed Regulations and Responses to Public Comments for Critical Access Hospitals

1. Organization Structure

2. Periodic Review of Clinical Privileges and Performance

3. Provision of Services (§ 485.635(a)(3)(vii))

4. Provision of Services (§ 485.635(g))

5. Infection Prevention and Control and Antibiotic Stewardship Programs (§ 485.640)

6. Quality Assessment and Performance Improvement (QAPI) Program (§ 485.641)

7. Technical Corrections

D. Requirements for Issuance of Regulations

E. Collection of Information Requirements for Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care

IV. Economic Analyses

A. Regulatory Impact Analysis for Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction

1. Statement of Need

2. Overall Impact

3. Anticipated Effects

4. Alternatives Considered

5. Uncertainty

6. Conclusion

B. Regulatory Impact Statement for Fire Safety Requirements for Certain Dialysis Facilities

C. Regulatory Impact Analysis for Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care

1. Statement of Need

2. Overall Impact

3. Anticipated Effects

4. Effects on Small Entities

5. Alternatives Considered

6. Conclusion

D. Accounting Statement and Table

E. Regulatory Reform Analysis Under E.O. 13771

I. Final Rule: Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction

A. Executive Summary and Background

1. Purpose

Over the past several years, we have revised our requirements, Conditions of Participation (CoPs) and Conditions for Coverage/Conditions for Certification (CfCs) to reduce the regulatory burden on providers and suppliers while emphasizing health and safety. We identified obsolete and burdensome regulations that could be eliminated or reformed to improve effectiveness or reduce unnecessary reporting requirements and other costs, with a particular focus on freeing up resources that health care providers, health plans, and States could use to improve or enhance patient health and safety. We also examined policies and practices not codified in rules that could be changed or streamlined to achieve better outcomes for patients while reducing burden on providers and suppliers of care, and we identified non-regulatory changes to increase transparency and to become a better business partner. In addition, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) have reaffirmed their commitment to the vision of creating an environment where agencies incorporate and integrate the ongoing retrospective review of regulations into Department operations to achieve a more streamlined and effective regulatory framework. The objectives were to improve the quality of existing regulations consistent with statutory requirements; streamline procedural solutions for businesses to enter and operate in the marketplace; maximize net benefits (including benefits that are difficult to quantify); and reduce costs and other burdens on businesses to comply with regulations.

In accordance with these goals, we published three final rules that identified unnecessary, obsolete, or excessively burdensome regulations on health care providers, suppliers, and beneficiaries. These rules further increased the ability of health care professionals to devote resources to improving health care by eliminating or reducing requirements that impede quality patient care or that divert providing high quality patient care:

• “Reform of Hospital and Critical Access Hospital Conditions of Participation”, published May 16, 2012 (77 FR 29034);

• “Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction”, published May 16, 2012 (77 FR 29002) and;

• “Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction; Part II”, published May 12, 2014 (79 FR 27105).

This final rule is a continuation of our efforts to reduce regulatory burden and is in accordance with the January 30, 2017 Executive Order “Reducing Regulation and Controlling Regulatory Costs” (Executive Order 13771). We are finalizing changes to the current requirements, CoPs, and CfCs that will simplify and streamline the current regulations and thereby increase provider flexibility and reduce excessively burdensome regulations, while also allowing providers to focus on providing high-quality healthcare to their patients. This final rule will also reduce the frequency of certain required activities and, where appropriate, revise timelines for certain requirements for providers and suppliers and remove obsolete, duplicative, or unnecessary requirements. We believe these policies balance patient safety and quality, while also providing broad regulatory relief for providers and suppliers.

In the proposed rule, we stated that we seek to reduce burdens for health care providers and patients, improve the quality of care, decrease costs, and ensure that patients and their providers and physicians are making the best health care choices possible. Therefore, we solicited public comments on additional regulatory reforms for burden reduction in future rulemaking. Specifically, we sought public comment on additional proposals or modifications to the proposals set forth in the proposed rule, “Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction,” published September 20, 2018 (83 FR 47686) that would further reduce burden on Medicare and Medicaid participating providers and suppliers and create cost savings, while also preserving quality of care and patient health and safety. We also noted in the proposed rule (83 FR 47686), consistent with our “Patients Over Paperwork” Initiative, that we are particularly interested in improving existing requirements, within our statutory authority, where the requirements as currently written make providing quality care difficult or less effective. We also noted that such suggestions could include or expand upon comments submitted in response to Requests for Information (RFIs) that were included in the 2017 prospective payment regulations for most provider types.

2. Summary of Major Provisions

We are reducing regulatory burden on providers and suppliers by modifying, removing, or streamlining current regulations that we now believe are unnecessary, obsolete or excessively burdensome. Specifically, we are finalizing the following revisions:

a. Discharge Planning in Religious Nonmedical Health Care Institutions (RNHCIs)

We have revised the requirements at 42 CFR 403.736(a) and (b) pertaining to a discharge plan. This revision simplifies the discharge process for RNHCIs by requiring them to assess the need for a discharge plan and provide discharge instructions to the patient and the patient's caregiver as necessary when the patient is discharged home.

b. Ambulatory Surgical Center (ASC): Transfer Agreements With Hospitals

We are replacing the requirement at § 416.41(b)(3), that ASCs have written transfer agreements or privileges with the local hospital with a requirement that ASCs must periodically provide the local hospital with written notice of its operation and patient population served.

c. ASC Requirements for Comprehensive Medical History and Physical Assessment

We are removing the current requirements at § 416.52(a) for a History and Physical within 30 days of the procedure and replacing them with requirements that defer, to a certain extent, to the ASC policy and operating physician's clinical judgment to ensure that patients receive the appropriate pre-surgical assessments tailored to the patient and the type of surgery being performed. We still require the operating physician to document any pre-existing medical conditions and appropriate test results, in the medical record, before, during and after surgery.

In addition, we have retained the requirement that all pre-surgical assessments include documentation regarding any allergies to drugs and biologicals, and that the medical history and physical examination (H&P), if completed, be placed in the patient's medical record prior to the surgical procedure.

d. Hospice Requirements for Medication Management

We are removing the procedural requirements at § 418.106(a)(1), related to having on the hospice staff, an individual with specialty knowledge of hospice medications.

e. Hospice Requirements: Orientation of Skilled Nursing Facility (SNF) and Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICF/IID) Staff

We are revising the requirements at § 418.112(f) to explicitly require hospices to coordinate with SNFs/NFs and ICFs/IID for assuring orientation of facility staff.

f. Hospital Quality Assessment and Performance Improvement Program (QAPI Program)

We are finalizing a new standard at 42 CFR 482.21(f), “Unified and integrated QAPI program for multi-hospital systems.” For a hospital that is part of a hospital system, consisting of multiple separately certified hospitals using a system governing body that is legally responsible for the conduct of two or more hospitals, the system governing body can elect to have a unified and integrated QAPI program for all of its member hospitals if the arrangement is in accordance with all applicable State and local laws. The system governing body is responsible and accountable for ensuring that each of its separately certified hospitals meets all of the requirements of this section.

g. Hospital Requirements for Comprehensive Medical History and Physical Examinations (§§ 482.22, 482.24, and 482.51)

We are allowing hospitals the flexibility to establish a medical staff policy describing the circumstances under which such hospitals can utilize a pre-surgery/pre-procedure assessment for an outpatient, instead of a comprehensive medical history and physical examination (H&P). We believe that allowing this option will greatly reduce the burden on the hospital, the practitioner, and the patient. In order to exercise this option, a hospital must document the assessment in a patient's medical record. The hospital's policy must consider patient age, diagnoses, the type and number of surgeries and procedures scheduled to be performed, comorbidities, and the level of anesthesia required for the surgery or procedure; nationally recognized guidelines and standards of practice for assessment of specific types of patients prior to specific outpatient surgeries and procedures; and applicable state and local health and safety laws.

h. Hospital Infection Control Program

We are broadly revising § 482.42, and issuing a new standard at § 482.42(d), “Unified and integrated infection prevention and control and antibiotic stewardship programs for multi-hospital systems.” Like the requirement for a unified and integrated QAPI program, the standard for infection control permits a hospital that is part of a hospital system consisting of multiple separately certified hospitals using a single governing body, such body can elect to have a unified and integrated infection prevention and control program for all of its member hospitals in accordance with all applicable State and local laws. The system governing body is responsible and accountable for ensuring that each of its separately certified hospitals meets all of the requirements of this section. Each separately certified hospital within the system must demonstrate that—the unified and integrated infection control program is established in a manner that takes into account each member hospital's unique circumstances and any significant differences in patient populations and services offered in each hospital; the unified and integrated infection control program establishes and implements policies and procedures to ensure that the needs and concerns of each of its separately certified hospitals, regardless of practice or location, are given due consideration, and that the unified and integrated infection control program has mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed; and a qualified individual (or individuals) has been designated at the hospital as responsible for communicating with the unified infection control program and for implementing and maintaining the policies and procedures governing infection control as directed by the unified infection control program.

i. Special Requirements for Psychiatric Hospitals

At § 482.61(d), we are clarifying the scope of authority for non-physician practitioners or Doctors of Medicine and Doctors of Osteopathic Medicine (MD/DOs) to document progress notes of patients receiving services in psychiatric hospitals.

j. Special Requirement for Transplant Centers and Definitions

We are making a nomenclature change at 42 CFR part 482 and the transplant center regulations at §§ 482.68, 482.70, 482.72 through 482.104, and at § 488.61. This change updates the terminology used in the regulations to conform to the terminology that is widely used and understood within the transplant community, thereby reducing provider confusion.

k. Data Submission, Clinical Experience, and Outcome Requirements for Re-Approval of Transplant Centers

We are removing the requirements at § 482.82 that state that transplant centers must meet all data submission, clinical experience, and outcome requirements in order to obtain Medicare re-approval. Transplant centers will still be required to comply with the CoPs at §§ 482.72 through 482.104 and the data submission, clinical experience, and outcome requirements for initial Medicare approval under § 482.80.

l. Special Procedures for Approval and Re-Approval of Organ Transplant Centers

We are revising § 488.61(f) through (h) to remove the requirements with respect to the re-approval process for transplant centers. This change corresponds to the proposed removal of the provisions at § 482.82. We are retaining the requirements in § 488.61(f) through (h) that pertain to the

initial

approval process for transplant centers.

m. Home Health Agency (HHA) Requirements for Verbal Notification of Patient Rights and Responsibilities

We are removing the requirements for verbal (meaning spoken) notification of all patient rights at § 484.50(a)(3), and replacing it with a requirement that verbal notice must be provided for those rights related to payments made by Medicare, Medicaid, and other federally funded programs, and potential patient financial liabilities as specified in the Social Security Act (the Act).

n. Personnel Requirements for Portable X-Ray Technologists

We are revising § 486.104(a), “Condition for coverage: Qualifications, orientation and health of technical personnel”, to focus on the qualifications of the individual performing services.

o. Portable X-Ray Requirements for Orders

We are revising the requirements for portable x-ray orders at § 486.106(a)(2) by removing the requirement that physician or non-physician practitioner's orders for portable x-ray services must be written and signed and replacing the specific requirements related to the content of each portable x-ray order with a cross-reference to the requirements at 42 CFR 410.32, which also apply to portable x-ray services.

p. Emergency Preparedness Requirements: Requirements for Emergency Plans

We are removing the requirements from our emergency preparedness rules for Medicare and Medicaid providers and suppliers that facilities document efforts to contact local, tribal, regional, State, and Federal emergency preparedness officials, and that facilities document their participation in collaborative and cooperative planning efforts.

q. Emergency Preparedness Requirements: Requirements for Annual Review of Emergency Program

We are revising this requirement so that applicable providers and suppliers review their Emergency program biennially, except for Long Term Care facilities, which will still be required to review their emergency program annually.

r. Emergency Preparedness Requirements: Requirements for Training

We are revising the requirement that facilities develop and maintain a training program based on the facility's emergency plan annually by requiring facilities to provide training biennially (every 2 years) after facilities conduct initial training for their emergency program, except for long term care facilities which will still be required to provide training annually. In addition, we are requiring additional training when the emergency plan is significantly updated.

s. Emergency Preparedness Requirements: Requirements for Testing

For inpatient providers, we are expanding the types of acceptable testing exercises that may be conducted. For outpatient providers, we are revising the requirement such that only one testing exercise is required annually, which may be either one community-based full-scale exercise, if available, or an individual facility-based functional exercise, every other year and in the opposite years, these providers may choose the testing exercise of their choice.

2. Proposals That Reduce the Frequency of Activities and Revise Timelines

a. Comprehensive Outpatient Rehabilitation Facility (CORF) Utilization Review Plans

We are amending the utilization review plan requirements at § 485.66 to reduce the frequency of utilization reviews from quarterly to annually. This would allow an entire year to collect and analyze data to inform changes to the facility and the services provided.

b. CAH Annual Review of Policies and Procedures

We are changing the requirement at § 485.635(a)(4) to require a CAH's professional personnel to, at a minimum, conduct a biennial review of its policies and procedures instead of an annual review.

c. Community Mental Health Center (CMHC) Requirements for Updating the Client Assessment

At § 485.914, we are removing the requirement that all CMHC clients receive an updated assessment every 30 days. Instead, we would require updates of the patient assessment in accordance with client needs and standards of practice. For clients receiving partial hospitalization services, we are retaining the 30-day assessment update time frame to be consistent with existing Medicare payment requirements for recertification of partial hospitalization services.

d. Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) Review of Patient Care Policies

We are revising the requirement at § 491.9(b)(4) that RHC and FQHC patient care policies be reviewed at least annually by a group of professional personnel, to review every other year in order to reduce the frequency of policy reviews.

e. RHC and FQHC Program Evaluation

We are revising the requirement at § 491.11(a) by changing the frequency of the required RHC or FQHC evaluation from annually to every other year.

3. Proposals That Are Obsolete, Duplicative, or That Contain Unnecessary Requirements

a. Hospice Aide Training and Competency Requirements

We are revising § 418.76(a)(1)(iv) to remove the requirement that a State licensure program meet the specific training and competency requirements set forth in § 418.76(b) and (c) in order for such licensure to qualify a hospice aide to work at a Medicare-participating hospice, deferring to State licensure requirements.

b. Medical Staff: Autopsies

We are finalizing our proposal to remove the requirement for hospitals at § 482.22(d), which states that a hospital's medical staff should attempt to secure autopsies in all cases of unusual deaths and of medical-legal and educational interest. We are deferring to State law regarding such medical-legal requirements.

c. Hospital and CAH Swing-Bed Requirements

We are removing the cross reference to § 483.10(f)(9) at § 482.58(b)(1) (for hospital swing-bed providers) and § 485.645(d)(1) (for CAH swing-bed providers); the repealed provisions gave a resident the right to choose to, or refuse to, perform services for the facility if they so choose.

We are removing the cross-reference to § 483.24(c) at § 482.58(b)(4) (for hospital swing-bed providers) and § 485.645(d)(4) (for CAH swing-bed providers) requiring that the facility provide an ongoing activity program based on the resident's comprehensive assessment and care plan directed by a type of qualified professional specified in the regulation.

We are removing the cross-reference to § 483.70(p) at § 482.58(b)(5) (for hospital swing-bed providers) and § 485.645(d)(5) (for CAH swing-bed providers requiring facilities with more than 120 beds to employ a social worker on full-time basis).

We are removing the cross-reference to § 483.55(a)(1) at § 482.58(b)(8) (for hospital swing-bed providers) and § 485.645(d)(8) (for CAH swing-bed providers) requiring that the facility assist residents in obtaining routine and 24-hour emergency dental care.

d. Home Health Agency Home Health Aide Requirements

We are revising § 484.80(c)(1) to clarify that skill competencies may be assessed by observing an aide performing the skill with either a patient or a pseudo-patient as part of a simulation. We are defining the terms “pseudo-patient” and “simulation” in § 484.2.

We are revising the requirement at § 484.80(h) related to completing a full competency evaluation when an aide is found to be deficient in one or more skills. Instead of completing a full competency evaluation, an aide would only be required to complete retraining

and a competency evaluation directly related to the deficient skills.

e. CAH Disclosure Requirements

We are removing § 485.627(b)(1), the requirement for CAHs to disclose the names of people with a financial interest in the CAH. This is currently a requirement under the program integrity requirements at 42 CFR 420.206, which are referenced in the provider agreement rules in 42 CFR 489.53(a)(8), making this CAH CoP requirement duplicative of those regulations.

3. Summary of Costs and Benefits for Regulatory Provisions To Promote Efficiency, Transparency, and Burden Reduction

1. Overall Impact

This final rule will create savings and reduce burden in many areas. Several of the changes will create measurable monetary savings for providers and suppliers, while others will create less quantifiable savings of time and administrative burden. We anticipate a total first year net savings of approximately $843 million, and slightly more in future years.

2. Section-by-Section Economic Impact Estimates

Table 1 summarizes the provisions for which we are able to provide specific estimates for savings or burden reductions (these estimates are uncertain and could be substantially higher or lower, as explained in the regulatory impact analysis section of this final rule):

Table 1—Summary of Net Savings by Provision

Provider and supplier type and description of proposed provisions

Frequency

Number of

affected

entities

Estimated savings (annualized, $millions)

Religious Nonmedical Health Care Institutions:

• Discharge Planning

As patients are discharged (Estimated 619 annual discharges)

18

(*)

Ambulatory Surgical Centers:

• Governing Body and Management

Upon failed hospital transfer agreement attempts

5,557

(*)

• Patient Admission, Assessment and Discharge (History and Physical)

Every patient registration at an ASC or at a hospital outpatient/

ambulatory surgery department

5,557

77.

• Medical Records

Recurring annually

5,557

0.

Hospices:

• Drugs and Biologicals, Medical Supplies, and Durable Medical Equipment ***

Recurring annually

4,602

94.

• Hospices That Provide Hospice Care to residents of a SNF/NF or ICF/IID

Recurring annually

4,602

1.

• Hospice Aide and Homemaker Services

Recurring annually

4,602

2.

Hospitals:

• Quality Assessment and Performance Improvement Program

Recurring annually

4,823

31.

• Medical staff: Autopsies

Recurring annually

4,823

0.

• Infection Control

Recurring annually

4,823

115.

• Special requirements for hospital providers of long-term care services (“swing-beds”)

Recurring annually

478

30.

• Special Requirements for Psychiatric Hospitals

Recurring annually

620

154.

• Patient Admission, Assessment and Discharge (History and Physical)

Every patient registration at an ASC or at a hospital outpatient/ambulatory surgery department

4,823

77.

Transplant programs:

• Various provisions related to performance **

Recurring annually

750

Not Quantified.

Home Health Agencies:

• Patient rights

Recurring annually

12,624

57.

• Home health aide services

Recurring annually

12,624

Not Quantified.

• Clinical records

Recurring annually

12,624

Not Quantified.

Critical Access Hospitals:

• Provision of Services

Recurring biennially

1,353

1.

• Organizational structure

Recurring annually

1,353

(*)

• Special requirements for CAH providers of long-term care services (“swing-beds”)

Recurring annually

1,246

77.

Comprehensive Outpatient Rehabilitation Facilities:

• Utilization Review Plan

Recurring annually

188

(*)

Community Mental Health Centers:

• Assessment Update

Recurring annually

52

(*)

Portable X-Ray Services:

• Qualifications of X-ray technicians ***

Recurring annually

500

31.

• Removing written orders

Recurring annually

500

28.

RHC (4,160 clinics) & FQHC (7,874 center locations):

• Patient Care Policies Review

Recurring biennially

12,034

4.

• Program Evaluation

Recurring biennially

12,034

5.

Emergency Preparedness for Providers and Suppliers:

• Review of Emergency Preparedness Program

Recurring biennially

56,983

70.

• Emergency Plan

Recurring annually

68,275

7.

• Training and Testing—Training Program

Recurring biennially

53,543

26.

• Training and Testing—Testing

Recurring annually

36,971

21.

* Amount is less than half a million dollars and rounds to zero.

** These include changes to the following requirements: Special Requirements for Transplant Programs; Data submission, Clinical Experience, and Outcome Requirement for Re-approval of Transplant Programs; and Special Procedures for Approval and Re-Approval of Organ Transplant Programs.

*** This estimate is for first full year savings only and will increase in future years.

B. Provisions of the Proposed Rule and Analysis and Response to Public Comments on “Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction”

In response to our September 20, 2018 proposed rule (83 FR 47686), we received 620 public comments. Commenters included individuals, healthcare professionals and corporations, national associations, health departments and emergency management professionals, and individual facilities that would be impacted by the regulation. Generally, the comments received were supportive. Most comments were centered around the proposed revisions to the emergency preparedness regulations for Medicare and Medicaid providers and suppliers. We have organized our responses to the comments as follows: (1) Comments specific to individual types of providers and suppliers (2); general comments; and (3) comments regarding our savings estimates.

1. Religious Nonmedical Health Care Institutions (RNHCIs)—Discharge Planning (§ 403.736(a) and (b))

Section 1861(ss)(1) of the Act defines the term “Religious Nonmedical Health Care Institution” (RNHCI) and lists the requirements that a RNHCI must meet to be eligible for Medicare participation.

Section 403.736(a) and (b) of the RNHCI's CoPs, as amended in the November 28, 2003

Federal Register

(68 FR 66710), requires RNHCIs to have a discharge planning process for patients.

Since the RNHCI's religious tenets prohibit conventional or unconventional medical treatment of a beneficiary, and medical post-institution services are not utilized by RNHCI patients, we believe that extensive discharge requirements are unnecessarily burdensome. Therefore, we proposed a more condensed and flexible process for discharge planning and instructions for RNHCIs. We proposed to remove the requirements at § 403.736(a) and (b), and proposed instead to require RNHCIs to provide discharge instructions to the patient or the patient's caregiver when the patient is discharged home.

The majority of commenters expressed strong support for the proposed changes to the RNHCIs discharge planning process. We did not receive any comments in opposition to the proposed requirement; therefore, we are incorporating the changes as proposed in this final rule.

Comment:

One commenter stated that they agreed with allowing flexibility and giving the institution the freedom to determine which patients should be provided a discharge plan. However, they commented that there should be a way to monitor this process to make institutions accountable and not omit providing a discharge plan if a patient needs one.

Response:

As for all providers and suppliers, Medicare surveys RNHCIs for compliance with the CoPs. We believe this enforcement process adequately ensures that RNHCIs are correctly interpreting and following our requirements.

Comment:

The majority of the commenters stated that they agree with the changes proposed to the discharge planning process at § 403.736(a) and (b). They stated that this change would reduce burden and allow greater flexibility to the RNHCIs.

Response:

We appreciate the comments received on the proposed changes for RNHCIs and will finalize the changes as proposed.

Final Rule Action:

We are finalizing the proposed changes without changes.

Contact:

Mary Collins, (410) 786-3189.

2. Ambulatory Surgical Centers

Section 416.2 of our rules defines an ambulatory surgical center (ASC) as any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization, in which the expected duration of services would not exceed 24 hours following an admission. The surgical services performed at ASCs are scheduled, primarily elective, non-life-threatening procedures that can be safely performed in an ambulatory setting. We received 99 timely public comments on our proposed changes to the ASC CfC requirements. Commenters included ASC industry associations, healthcare systems, national accreditation organizations, clinician associations, individual ASCs, and clinicians. Overall, the majority of the commenters were supportive of the goals of the proposed changes. Summaries of the major issues and our responses are set forth below.

a. Governing Body and Management; Hospitalization Requirements (§ 416.41(b)(3)(i) and (ii))

We proposed to remove the requirement for a written hospital transfer agreement or hospital physician admitting privileges at § 416.41(b)(3). The requirements in § 416.41(b)(1) and (2) continue to require the ASC to have an effective procedure for the immediate transfer, to a hospital, of patients requiring emergency medical care beyond the capabilities of the ASC and that the hospital must be a local hospital that meets the requirements for payment for emergency services under § 482.2. As part of this revision, ASCs are not precluded from obtaining hospital transfer agreements or hospital physician admitting privileges when possible.

Comment:

The comments submitted regarding the removal of the transfer agreement were almost evenly split between supporters and opponents. Specifically, the ASCs supported the removal of the transfer agreement and hospitals were opposed to the removal of the transfer agreement. Comments in support of removal of the written hospital transfer agreement stated that the current requirement is unnecessary, obsolete and extremely burdensome because of the small number of patient transfers, the creation of The Emergency Medical Treatment and Labor Act (EMTALA), and the exhaustive administrative paperwork and negotiation burden that is required when the local hospital system refuses to sign the written hospital transfer agreement. Comments in support of the

removal also stated that ASCs should not be forced to close their businesses because regulations cannot be met due to competition issues with the local hospital and their outpatient surgery center. Comments opposing removal of the written hospital transfer agreement stated that transfer agreements have the potential to ensure that there is a plan for emergencies, that appropriate continued care will be delivered, and that both the ASC and hospital communicate with one another. In addition, we received several comments that suggested the regulation should instead specify that the ASC would be deemed to have met the hospital transfer agreement provision if a “good faith effort” was documented. One commenter suggested that instead of an all or nothing provision, ASCs should periodically provide local hospitals with a written notice. The commenter contended that this requirement would notify the hospital of ASC services in the community and the types of patients that are receiving care that may need additional care beyond the capability of the ASC.

Response:

We continue to believe that, because of the existing EMTALA regulations, the small number of transfers, and the burden ASCs incur when faced with local hospital competition issues, removing this requirement is necessary and appropriate. We agree that communication between ASCs and hospitals is important; however, we do not agree that a mandated transfer agreement is a necessary or effective method to assure this communication. In response to the commenter's suggestions described above, and to assure that hospitals are aware of the potential for receiving patient transfers from an ASC, we are revising our proposal at § 416.41(b)(3) to require the ASC to periodically provide the local hospital with written notice of its operation and patient population served. For example, the notice would include details such as hours of operation and the procedures that are performed in the ASC. Providing written notice, rather than securing a transfer agreement, will alleviate the administrative burden of negotiating or being denied negotiating opportunities associated with the requirement of a written transfer agreement between the ASC and hospital. We are requiring that the notice be provided “periodically” to the local hospital to ensure the ASC keeps the local hospital informed and up-to-date on ASC information and any patient population changes. The “periodically” phrasing is similar to the reappraisal requirement for the medical staff privileges in ASCs located at § 416.45(b), “Medical staff- Standard: Reappraisals”, and is meant to have the same meaning. This change does not preclude those ASCs and hospitals with functional working relationships to continue to have written transfer agreements, which we encourage, and prior preparations in place for patient transfers in the event of an emergency.

b. Patient Admission, Assessment and Discharge (§ 416.52(a)(1), (2), (3) and (4))

The current regulations at § 416.52 require ASCs to ensure that a physician or other qualified practitioner provide a comprehensive medical history and physical assessment (H&P) completed not more than 30 days before the date of the scheduled surgery.

We proposed to remove the current requirements at § 416.52(a) and replace them with requirements under the facility's established policies for pre-surgical medical histories and physical examinations (H&P), including any associated testing, and the operating physician's clinical judgment, to ensure patients receive the appropriate pre-surgical assessments that are tailored for the patient and the type of surgery being performed. We proposed to require each ASC to establish and implement a policy that identifies patients who require an H&P prior to surgery. We proposed that the policy would include the time frame for the H&P to be completed prior to surgery. We proposed that the policy would be required to consider the age of patients, their diagnoses, the type and number of surgeries that are scheduled to be performed at one time, all known comorbidities, and the planned level of anesthesia for the surgery to be performed. ASCs would not be limited to these factors, and would be permitted to include others to meet the needs of their patient populations. Furthermore, we proposed that each ASC's policy would be required to follow nationally recognized standards of practice and guidelines, as well as applicable state and local health and safety laws. To conform to the proposed changes to the medical history and physical examination requirements at § 416.52(a), we proposed to revise the requirement at § 416.47(b)(2), that states “Significant medical history and results of physical examination,” by adding “as applicable.”

Comment:

A majority of commenters supported the proposed change to remove the medical H&P examination requirement no more than 30 days before the date of the scheduled surgery, and defer to the ASCs established policies for pre-surgical H&Ps and the operating physician's clinical judgment. The comments agreed that allowing ASCs flexibility to establish patient policies, and encouraging the use of clinician judgment, are appropriate to assure patient health and safety while also reducing the burden on patients and providers, and reducing expenditures on potentially unnecessary pre-operative testing that is performed because it is required by policy. However, a small number of comments supported only part of this change, suggesting instead that CMS should retain the H&P requirement while allowing the ASC the discretion to determine the timeframe for the H&P relative to the date of surgery. Another commenter opposed any changes and recommended retaining the H&P requirement and 30-day time frame. One commenter stated that they believe the burden of assessing patients prior to surgery would be shifted from one provider (the primary care physician) to another (the anesthesiologist), and that allowing ASCs the flexibility to establish their own policies based on their clinical judgment and patient population needs would burden ASCs and healthcare workers, create inefficiencies, and lead to variations in standards of care from facility to facility.

Response:

We appreciate the support of the vast majority of commenters, and continue to believe that the change is appropriate to support patient health and safety while eliminating the burdens of potentially unnecessary examinations and tests. The content of ASC-wide policies surrounding the appropriate use of medical histories and physicals, as well as pre-operative testing, could be informed by specialty societies, medical literature, past experience, or other factors. We disagree that variations between facilities would be an inherently undesirable effect of the change; variations to take into account unique patient needs and facility characteristics are preferable to a “one size fits all” approach of mandatory 30 day H&Ps. Allowing ASCs and physicians to work together to implement their own policies, based on their clinical judgment and patient population served, will provide the most optimal balance between burden and necessary examinations and testing, by identifying when a medical H&P examination should be completed, if appropriate. We are finalizing the proposal to require ASCs to address certain patient characteristics, such as age, diagnosis, the type and number of procedures, comorbidities and the planned anesthesia level, when

developing their policies and procedures for pre-surgical examinations and testing. We believe this change will ensure those patients who would actually be protected by a medical H&P examination will receive one based on ASC policy, and in a time frame established by that policy, thereby reducing burden on physicians, facilities, and patients. We reiterate that ASCs are still required to perform a patient assessment upon admission before surgery, that the ASC is not precluded from retaining the H&P requirement in facility policies, and that we are not discouraging pre-surgical H&Ps where clinically indicated.

Comment:

One commenter expressed concern over the wording of the proposed regulation text in § 416.52(a)(1)(iii), stating that the ASC policy must follow nationally recognized standards of practice and guidelines. The commenter believed the term “follow” could be problematic for ASCs, and be interpreted as being required to “adhere” to national guidelines that are not delineated, thus depriving the ASC of the ability to determine what clinical practices make the best sense for its patients.

Response:

We agree and have revised the regulation text to be consistent with the regulation text that is being finalized for hospital outpatient H&P requirements. We are finalizing the regulation text to state that the ASC policy must be based on any applicable nationally recognized standards of practice and guidelines, and any applicable State and local health and safety laws.

Comment:

One commenter asked CMS to coordinate any changes to the regulations with updates to the accreditation organizations (AOs) standards.

Response:

National accreditation organizations must meet or exceed CMS standards, and their standards must be updated, as appropriate, to reflect changes in the CMS regulations. As AOs may choose to exceed CMS requirements, so they may choose to retain any or all of the requirements that we are removing in this final rule to the extent that they do not conflict with any of our revisions.

We did not receive any public comments on the proposed technical change to the medical records proposed at § 416.47(b)(2) and are finalizing the technical change to the medical records section as proposed.

Final Rule Action:

1. Rather than deleting, we are finalizing revisions to § 416.41(b)(3) to require ASCs to periodically provide the local hospital with written notice of its operation and patient population served.

2. We are finalizing the proposal to revise the requirement at § 416.47(b)(2), to state “Significant medical history and results of physical examination, as applicable.”

3. We are finalizing the proposal to eliminate the requirement at § 416.52(a) for each patient to have a medical history and physical assessment completed by a physician not more than 30 days before the scheduled surgery, and replace it with the requirement for ASCs to develop and maintain a policy that identifies those patients who require a medical history and physical examination prior to surgery. In addition, require the policy to include the timeframe for the medical history and physical examination to be completed prior to surgery. The policy must also address, but not be limited to, the following factors: Patient age, diagnosis, the type and number of procedures scheduled to be performed on the same surgery date, known comorbidities, and the planned anesthesia level. Upon admission, each patient must have a pre-surgical assessment completed by a physician or other qualified practitioner in accordance with applicable State health and safety laws, who will be performing the surgery.

4. We are revising § 416.52(a)(1)(iii) to clarify that the ASC policy must be based on nationally recognized standards of practice and guidelines, and applicable State and local health and safety laws.

Contact:

CAPT Jacqueline Leach, USPHS, 410-786-4282.

3. Hospice

a. Hospice Aide and Homemaker Services (§ 418.76)

We proposed to revise § 418.76(a)(1)(iv) to remove the requirement that a hospice aide training State licensure program must meet the specific training and competency requirements set forth in § 418.76(b) and (c) in order to be deemed an appropriate qualification for employment. This change would defer to State licensure requirements, except in states where no requirements exist.

Comment:

Many comments supported the proposed revision to defer to existing state requirements for hospice aide training, and only impose Federal requirements in the absence of state standards. However, other comments did not support this proposed change, arguing that state education and training standards for hospice aides should not be accepted as being sufficient to assure patient health and safety.

Response:

Deference to state-established standards regarding the training and competency of health care professionals is standard practice. States already establish such standards for health care professions such as nursing, laboratory technicians, phlebotomists, and therapists, to name a few. Seventy-six percent of states have already established their own qualification standards for aides, aides furnishing services in those states are already permitted to provide services to individuals through private pay agencies without meeting the Medicare standards, and there is no indication that these already applicable standards are insufficient to assure patient health and safety. As deference to state standards is the norm across the health care spectrum, and as current state standards are already demonstrated to be sufficient to assure patient health and safety, we see no reason to impose a separate Federal standard. Therefore, we are finalizing this proposed change. In the absence of state requirements, hospices will continue to be required to assure that an aide meets the Federal training standards. Furthermore, all hospices in all states will continue to be required to comply with the existing requirements that hospice aides may only perform those skills that are consistent with the training that the aide has received (§ 418.76(g)(2)(iv)), and that, if an area of concern is verified by the hospice during an on-site aide supervision visit, then the hospice must conduct, and the hospice aide must complete, a competency evaluation in accordance with § 418.76(c) and (h)(1)(iii).

b. Drugs and Biologicals, Medical Supplies, and Durable Medical Equipment (§ 418.106(a)(1) and (e)(2)(i))

We proposed to delete the requirements at § 418.106(a)(1), which required hospices to ensure that the interdisciplinary group confers with an individual with education and training in drug management as defined in hospice policies and procedures and State law, who is an employee of or under contract with the hospice, to ensure that drugs and biologicals meet each patient's needs. Meeting each patient's needs would continue to be the responsibility of all Medicare-participating hospices in accordance with the requirements of all other hospice CoPs.

Comment:

We received numerous comments that both supported and opposed the proposal to eliminate the process requirement that a hospice must confer with an individual with expertise in medication management regarding

the plan of care for each patient. Many commenters agreed that this process requirement is no longer necessary because this is standard practice in hospices. However, other commenters, while agreeing that it is standard practice, still believe that there is value in having a distinct regulatory requirement to this effect, due to the important role that medications play in hospice care and the potential for safety lapses.

Response:

Hospices would continue to be required to comprehensively assess patients on a regular schedule and on an as needed basis in accordance with the requirements of § 418.54(a), (b) and (d), and to assure that each patient's plan of care is developed and continually updated to meet each patient's needs as identified in the assessment process in accordance with the requirements of§ 418.56(b) through (d). These existing regulations, which we are not revising, focus on assuring the outcomes of safe, effective, patient-centered care. Furthermore, hospices will still be required to comply with the quality assessment and performance improvement (QAPI) CoP at § 418.58, which requires hospices to monitor patient outcomes and implement improvement projects to address identified areas of concern. To the extent that patient outcomes are not being achieved due to problems with medication management, both the hospice's internal QAPI program and the external hospice survey process will be capable of identifying and addressing those problems, regardless of the removal of this process requirement. In light of these existing requirements, and in response to the support for the proposed change expressed by a variety of commenters, we are finalizing the proposed change to remove the process requirement at § 418.106(a)(1) without revisions.

We proposed to replace the requirement at § 418.106(e)(2) that hospices provide a physical paper copy of policies and procedures, which are written to guide the actions of hospice staff, with a requirement that hospices provide information regarding the use, storage, and disposal of controlled drugs to the patient or patient representative, and family, which can be developed in a manner that speaks to the perspectives and information needs of patients, families, and caregivers. This information would be provided in a more user-friendly manner, as decided by each hospice. Hospices would be free to choose the content and format(s) that best suits their needs and the needs of their patient population. We proposed to require that, regardless of the format chosen, this information would have to be provided to patients, families and caregivers in a manner that allowed for access to the information on a continual, as-needed basis.

We would continue to require that hospices discuss the information regarding the safe use, storage and disposal of controlled drugs with the patient or representative, and the family/caregiver(s), in a language and manner that they understand to ensure that these parties are effectively educated. This requirement is included in the current hospice CoPs and is consistent with Department of Health and Human Services guidance regarding Title VI of the Civil Rights Act (“Guidance to Federal Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons,” 68 FR 47311, August 8, 2003,

https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/guidance-Federal-financial-assistance-recipients-title-VI/

). We continue to expect hospices to utilize technology, such as telephonic interpreting services and any other available resources for oral communication in the individual's primary or preferred language. We would also continue to require that hospices document in the patient's clinical record that the information was provided and discussed.

Comment:

We received many comments regarding the proposed change to allow hospices to determine the content and form of the controlled drug storage, use, and disposal notice for patients and families. Commenters universally supported the goal of improving patient and family education on this subject and supported the shift away from providing policies and procedures. However, a few commenters raised concern about the intersection of this change with section 3222 of the recently adopted Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”) (Pub. L. 115-271), that requires hospices, which permit their employees to dispose of medications in the patient's home, to provide their written policies and procedures to patients, families and caregivers. This provision, which amends section 302 of the Controlled Substances Act (21 U.S.C. 822), is under the jurisdiction of the Department of Justice.

While most commenters expressed appreciation for the proposal to allow hospices to determine the form and content of the notice, other commenters suggested that CMS should develop education materials that hospices must provide to patients and families. Whether hospice or CMS-generated, commenters suggested that using alternative formats such as pictorial infographics and videos may be valuable tools in communicating this important information. Commenters also suggested that the information should be accessible to all individuals, regardless of impairments or language spoken.

Response:

In light of the changes included in section 3222 of the SUPPORT Act, it is not appropriate to finalize this proposed change. However, we encourage hospices to develop easily understood materials that explain safe storage, use, and disposal of controlled drugs to patients, their families, and caregivers in addition to meeting the regulatory requirement to provide a copy of the hospice's clinical policies and procedures. We continue to believe that providing such materials is a positive practice for improving comprehension of this crucial information and improving compliance with safe handling, use, and disposal practices.

c. Hospices That Provide Hospice Care to Residents of a SNF/NF or ICF/IID (§ 418.112(c)(10) and (f))

Section 418.112(f) of the hospice CoPs, as finalized in the 2008 Hospice CoP final rule (73 FR 32088), requires hospices to assure orientation of Skilled Nursing Facility/Nursing Facility (SNF/NF) or ICF/IID staff furnishing care to hospice patients. We proposed to remove § 418.112(f) and add a new requirement at § 418.112(c)(10), “Written agreement,” to permit both entities to negotiate the mechanism and schedule for assuring orientation of facility staff.

Comment:

While comments supported the intent behind the proposed change to permit hospices and long term care facilities to negotiate the roles and responsibilities for orienting long term care facility staff to the hospice philosophy of care and hospice procedures, some comments did not support moving the topic into the content of the written agreement. Comments stated that requiring this subject to be addressed in the written agreement would create a onetime burden for hospices of renegotiating the written agreement with each long term care facility, and that this burden was not acceptable even in light of the potential long-term regulatory relief of the proposed change. Some comments suggested that the current regulations at

§ 418.112(f) instead be revised to allow for hospices and facilities to negotiate their respective roles and responsibilities outside of the written agreement.

Response:

We agree with commenters that the goal of regulatory flexibility is worthwhile, and we appreciate the feedback regarding the scope of the regulatory burden that would be incurred when renegotiating existing contracts with long term care facilities. In light of the burden concerns raised in the comments, we agree that a different approach to achieving the same goal is warranted. We are not finalizing the proposal to move the requirements related to facility staff orientation and training from a standalone requirement to a provision in the written agreement. In order to achieve the original regulatory goal of adding flexibility and reducing hospice costs for this activity, we are revising existing § 418.112(f), Orientation and training of staff, to clarify that a hospice must consult with and thus share responsibility with the facility to assure facility staff orientation and training. We received 26 timely public comments pertaining to all proposed changes to the hospice requirements. Commenters included hospice industry associations, individual hospice providers, national accrediting organizations, clinician associations, and consumer advocacy groups. Overall, the majority of commenters were supportive of the goal of the proposed changes. Comments not directly related to our proposals are summarized below.

Comment:

A few comments specifically related to the hospice CoPs were submitted in response to the solicitation for ideas for further burden reduction efforts. Comments included removing the core services requirement for dietary counseling and providing waivers for social worker supervision.

Response:

We appreciate the suggestions, and will consider revising the social work supervision requirements in future rulemaking. The hospice interpretive guidelines related to § 418.114(b)(3) (State Operations Manual, Pub. 100-07, Appendix M,

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_m_hospice.pdf,

accessed on January 16, 2019) state, “Each hospice must employ or contract with at least one MSW to serve in the supervisor role. . . .” We believe that this existing flexibility regarding contracting for this service, when coupled with the fact that the supervision role can be performed remotely, is adequate to address concerns regarding the provision of social work supervision at this time while we consider this waiver suggestion. Dietary counseling as a core service is a statutory requirement (see section 1861(dd)(2)(A)(ii)(I) of the Act)) and cannot be repealed through regulatory mechanisms.

Comment:

We received numerous comments with suggestions related to Medicare payment requirements for hospice services (for example, notice of election requirements and the coverage requirements for continuous home care level of care), use of the CMS Common Working File, hospice quality measures, Medicaid payment issues, and Medicare audits.

Response:

These comments are not within the scope of this regulation, which is related to the health and safety standards for Medicare providers. We publish an annual proposed hospice payment rule, and comments related to payment policies and rates may also be submitted to that rule for consideration. All out of scope comments have been shared with the appropriate components within CMS.

Final Rule Action:

1. We are finalizing the proposed changes to §§ 418.76(a)(1)(iv) and 418.106(a)(1) without change. We are not finalizing our proposed change to 418.106(e)(2)(i).

2. Revise § 418.112(f) to require hospice and facilities to share responsibility for facility staff orientation and training.

Contact:

Danielle Shearer, 410-786-6617.

4. Hospitals

a. Quality Assessment and Performance Improvement Program (§ 482.21)

We proposed a new standard at § 482.21(f), “Unified and integrated QAPI program for multi-hospital systems.” We would allow that for a hospital that is part of a hospital system consisting of two or more separately certified hospitals subject to a system governing body legally responsible for the conduct of each hospital, the system governing body could elect to have a unified and integrated QAPI program for all of its member hospitals after determining that such a decision is in accordance with all applicable State and local laws. The system governing body would be responsible and accountable for ensuring that each of its separately certified hospitals meets all of the requirements of this section. Each separately certified hospital subject to the system governing body would have to demonstrate that: The unified and integrated QAPI program was established in a manner that took into account each member hospital's unique circumstances and any significant differences in patient populations and services offered in each hospital; and the unified and integrated QAPI program establishes and implements policies and procedures to ensure that the needs and concerns of each of its separately certified hospitals, regardless of practice or location, are given due consideration, and that the unified and integrated QAPI program has mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed.

Comment:

Most commenters supported the proposal to allow hospitals that are part of a multi-hospital system to have a unified and integrated QAPI program. A few commenters expressed appreciation for the expanded flexibility that this proposal would afford hospitals by reducing burden, increasing efficiencies, and eliminating the duplication of efforts.

A few commenters generally supported this proposal, but recommended that individual, hospital-specific data be recorded and made available to the system's governing body and the public. These data, the commenters stated, would help to identify best practices and processes from facilities that are excelling in certain areas and will account for and address performance outliers across the broader hospital system. Finally, another commenter expressed concern that the proposed requirement might group QAPI scores together and hide poor performance, which they stated may mislead consumers about the site-specific care they are receiving.

Response:

We thank the commenters for their support. We believe that a hospital's governing body should be afforded the option of unifying and integrating the various member hospitals within their multi-hospital system into a unified QAPI program. Such a model would incorporate each individual hospital's QAPI program, which would enable increased efficiencies, innovations, provider flexibility, and allow for the dissemination of best practices for patient care while also potentially improving patient safety and outcomes. We also believe that a unified QAPI model is a natural progression for a multi-hospital system that utilizes a system governing body (as allowed at § 482.12) and a unified medical staff (as allowed at § 482.22).

In response to the commenter's concerns regarding individual hospital data, we agree that hospital specific data should be used to address specific

individual hospital issues and to identify and disseminate best practices. As we have proposed, “the system governing body is responsible and accountable for ensuring that each of its separately certified hospitals meets all of the requirements of this section.” We do not see this requirement as prohibiting an individual hospital from reporting its own data to the governing body and most especially to the unified and integrated QAPI program, since we are requiring that each separately certified hospital in the system demonstrate that the unified and integrated QAPI program takes into account each member hospital's unique circumstances as well as any significant differences in patient populations and services offered in each hospital. Each hospital must also demonstrate that the unified and integrated program has mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed.

We are unclear as to what the commenter means by “QAPI scores” and to what the commenter is referring regarding the grouping of “QAPI scores together” in order to “hide poor performance.” The current QAPI CoP does not require anything related to “QAPI scores” and we are not finalizing any such requirements in this rule. We believe that the commenter might have been confusing QAPI with the various data that are collected for the Inpatient Quality Reporting Program. These programs are unrelated and the quality reporting program remains unchanged by this rule.

Comment:

One commenter recommended that CMS include the following language in proposed § 482.21(f)(2) regarding a hospital's medical staff: “. . . Including consulting with each of its separately certified hospital's medical staff.” The commenter stated that a hospital's medical staff brings a unique clinical perspective to the activities of the governing body with regard to quality and safety issues. The commenter also urged CMS to clarify that the proposed requirement will not include an Ongoing Professional Practice Evaluation and Focused Professional Practice Evaluation, which they state, is the responsibility of the hospital's medical staff.

Response:

While we agree with the commenter that a hospital's organized medical staff brings a unique clinical perspective to the activities of the governing body with regard to quality and safety issues, we believe that a number of the hospital CoPs already effectively ensure that this clinical perspective is heard by the governing body while also holding the medical staff responsible and accountable for these patient safety and quality of care issues. For example, the provision at § 482.12(a)(1), under the hospital Governing body CoP, requires that the hospital's governing body must, “consult directly with the individual assigned the responsibility for the organization and conduct of the hospital's medical staff, or his or her designee. At a minimum, this direct consultation must occur periodically throughout the fiscal or calendar year and include discussion of matters related to the quality of medical care provided to patients of the hospital.” This requirement applies to all hospitals, governing bodies, and medical staffs, regardless of organizational structure.

Additionally, the QAPI CoP itself, at § 482.21(e), contains a standard that requires the hospital medical staff (among other hospital leaders) to be responsible and accountable for ensuring that the QAPI program is focused on improved quality of care and patient safety. Similarly, the Medical staff CoP requirement at § 482.22(b) requires that the hospital's medical staff “must be well organized and accountable to the governing body for the quality of the medical care provided to patients.” And finally, at § 482.22(b)(4)(iii) and (iv), the CoPs require that a separately certified hospital, which uses a unified and integrated medical staff accountable to a system governing body, must demonstrate that its unified and integrated medical staff: (1) Is established in a manner that takes into account each member hospital's unique circumstances and any significant differences in patient populations and services offered in each hospital and (2) establishes and implements policies and procedures to ensure that the needs and concerns expressed by members of the medical staff, at each of its separately certified hospitals, regardless of practice or location, are given due consideration, and that the unified and integrated medical staff has mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed. Therefore, we do not believe that any additional language is needed here.

Comment:

One commenter requested that CMS include “affiliates” and CAHs in the unified and integrated QAPI and infection control requirements. The commenter defines “affiliates” as hospitals and providers within a healthcare system that may bill under separate Tax Identification Numbers (TINs). The commenter noted that this option would afford hospitals additional flexibility and ease administrative burden.

Response:

We are not clear on whether the commenter is confusing TINs and CMS Certification Numbers (CCNs), which CMS uses to distinguish separately certified hospitals, CAHs, and other Medicare-participating providers and suppliers for survey and certification purposes in determining compliance with the CoPs and CfCs specific to each provider and supplier type. We do not use TINs in our determination of when a facility requires separate certification.

A CAH must be separately evaluated for its compliance with the CAH CoPs (found at 42 CFR part 485, subpart F), which would not include the requirements included in this section of the rule since these are hospital CoPs. 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.

Final Rule Action:

We are finalizing the requirements in § 482.21(f), without modification.

Contact:

Alpha-Banu Wilson, 410-786-8687.

b. Medical Staff, Medical Records Services, and Surgical Services (§§ 482.22, 482.24, and 482.51)

Hospital Medical History and Physical Examination Requirements

We proposed to revise the current requirements at § 482.22(c)(5)(i) and (ii) with respect to medical staff bylaws, and to allow for an exception under the proposed paragraph (c)(5)(iii). We are retaining the current language in paragraphs (c)(5)(i) and (ii) that the H&P, and any update to it, must be completed and documented by a physician (as defined in section 1861(r) of the Act), an oral and maxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy. We proposed to include this same language regarding who can complete and document the assessment in the proposed provision at § 482.22(c)(5)(iii). This provision would require the medical staff bylaws to state that an assessment of the patient (in lieu of the requirements of paragraphs (c)(5)(i) and (ii)) be completed and documented after registration, but prior to surgery or a procedure requiring anesthesia services, when the patient is

receiving specific outpatient surgical or procedural services and when the medical staff has chosen to develop and maintain a policy that identifies, in accordance with the requirements at paragraph (c)(5)(v), specific patients as not requiring a comprehensive medical history and physical examination, or any update to it, prior to specific outpatient surgical or procedural services. The proposed paragraphs (c)(5)(iii) and (iv) would require the medical staff to develop and maintain a policy that identifies those patients for whom the assessment requirements of paragraph (c)(5)(iii) would apply. We also proposed a new requirement at paragraph (c)(5)(v) for a medical staff that chooses to develop and maintain a policy for the identification of specific patients to whom the assessment requirements in paragraph (c)(5)(iii) would apply. Under this proposed paragraph, if the medical staff exercised the option to perform a simplified assessment in some cases, the written policy would have to indicate the specific outpatient surgical or procedural services to which it applied. The policy for each procedure would need to indicate the hospital's consideration of patient age, diagnoses, the type and number of surgeries and procedures scheduled to be performed, comorbidities, and the level of anesthesia required for the surgery or procedure; nationally recognized guidelines and standards of practice for assessment of specific types of patients prior to specific outpatient surgeries and procedures; and applicable State and local health and safety laws.

In order to make clear that this proposed requirement would be an option that a hospital and its medical staff could elect to use at their discretion, we proposed language that states “the provisions of paragraphs (c)(5)(iii), (iv), and (v) do not apply to a medical staff that chooses to maintain a policy that adheres to the requirements of paragraphs (c)(5)(i) and (ii) for all patients.” In other words, a hospital and its medical staff would be free to exercise their clinical judgment in determining whether a policy for identifying specific patients as not requiring a comprehensive H&P (or any update to it) prior to specific outpatient surgical or procedural services, and instead requiring only a pre-surgical assessment for these patients, would be their best course. Or, if a hospital and its medical staff decided against such a policy, then only the current H&P and update requirements (at §§ 482.22, 482.24, and 482.51) would continue to apply and the proposed requirements for this CoP, as well as those proposed for §§ 482.24 and 482.51, would not apply.

For the current CoP at § 482.24, “Medical Record Services,” we specified that we would revise the provisions at § 482.24(c)(4)(i)(A) and (B) regarding an H&P and its update to allow for an exception under proposed paragraph (c)(4)(i)(C) where we proposed to add a new requirement that, if applicable, the medical record would have to document assessment of the patient (in lieu of the requirements of paragraphs (c)(4)(i)(A) and (B)) after registration, but prior to surgery or a procedure requiring anesthesia services, for specific outpatient surgical or procedural services.

We also proposed to revise the current CoP, § 482.51, “Surgical Services,” to allow for an exception to the requirements at § 482.51(b)(1)(i) and (ii). Under proposed paragraph (b)(1)(iii), we proposed a new requirement that, prior to surgery or a procedure requiring anesthesia services and except in the case of emergencies, an assessment of the patient must be completed and documented after registration (and in lieu of the requirements of paragraphs (b)(1)(i) and (ii)). This proposed requirement would only apply in those instances when the patient is receiving specific outpatient surgical or procedural services and when the medical staff has chosen to develop and maintain a policy that identifies, in accordance with the requirements at § 482.22(c)(5)(v), specific patients as not requiring a comprehensive medical history and physical examination, or any update to it, prior to specific outpatient surgical or procedural services.

Comment:

As reflected in the public comments for similar proposed changes for ASCs that we have previously discussed, the majority of comments submitted were supportive of the proposed changes that would give a hospital and its medical staff the flexibility to establish a policy for a pre-surgical or pre-procedural assessment of the patient (in lieu of the requirements of paragraphs (c)(5)(i) and (ii) for a comprehensive pre-surgical or pre-procedural H&P and its update), provided that the patient assessment is completed and documented after registration, but prior to surgery or a procedure requiring anesthesia services, and the patient is receiving specific outpatient surgical or procedural services as outlined in the policy. Several commenters stated that they appreciated the regulatory flexibility to establish specific patient policies such as these as long as they are based on recognized guidelines and best practices as well as on the clinical judgment of the medical staff. They stated that they believe such parameters are necessary to ensure patient health and safety while still allowing for reasonable methods to reduce the burden on both patients and providers, including the additional expense of pre-operative testing that is often performed unnecessarily on many patients undergoing only minor outpatient procedures and may be an unintended consequence of the requirement for a comprehensive H&P within 30 days of admission or registration for all hospital patients regardless of the surgery or procedure that they are undergoing.

Response:

We thank the commenters for their support and agree that the flexibility provided by these revisions will reduce unnecessary regulatory burden affecting both patients and providers. We believe that it also has the potential to greatly reduce unnecessary costs associated with the current requirements for a comprehensive H&P for a specific class of patients undergoing low-risk outpatient surgeries and procedures for which there exist clear guidelines regarding the extent of pre-operative patient assessment and testing needed.

Comment:

Some commenters either did not support these changes or had certain reservations about them, even though they supported the overall intent of the changes. One commenter stated that the change will not serve those beneficiaries with advanced illness well, recommended that the rule be revised to require that the assessment must be consistent with the patient's situation, medical complexity, and the proposed procedure, and believes that the requirements must err on the side of more, rather than less, comprehensiveness. Another commenter stated that while they appreciated CMS' recognition that the timing of H&Ps may, in some instances, be duplicative and cause unnecessary burden, they were aware of cases where the current H&P requirements prevented an adverse event. They also stated that the proposed revisions will be just as, and possibly more, burdensome than the current requirements; that CMS should consider comments before proceeding; and that, while they agree that there seems to be no evidence supporting a strict 30-day requirement, additional flexibility would be appreciated. One commenter stated that they believe the burden of assessing patients prior to surgery would be shifted from one provider (the primary care physician or the surgeon) to another (the anesthesiologist), and

expressed concerns over the increased responsibility and liability that might be then imposed on an anesthesiologist (beyond his or her primary responsibility for anesthesia services and care provided to a patient) for a surgery or procedure in which he or she was not the operating practitioner. A few commenters also expressed concerns over whether reimbursement requirements and rates would now change for outpatient surgeries and procedures that would only require an assessment and not a comprehensive H&P, including concerns over which practitioner would now be reimbursed for the assessment (for example, the patient's primary care practitioner versus the operating practitioner).

Response:

We appreciate the concerns raised by commenters and have thoroughly considered them. However, we must again note and emphasize to readers that this revision will be a regulatory option available to hospitals and one that a hospital and its medical staff must make the policy decision to exercise. We expect that this decision will be based on the clinical judgment and recommendations of the medical staff, which must be supported by nationally recognized evidence and guidelines for best practices in this area, in order for the hospital to determine if the best course would be to establish a policy for identifying specific patients as not requiring a comprehensive H&P (or any update to it) prior to specific outpatient surgical or procedural services, and instead require a more limited pre-surgical assessment for these patients. We expect that most hospitals and their medical staffs will perform risk/benefit analyses to inform their decisions. We also expect that a number of these hospitals, based on their analyses, will decide to maintain a policy that continues to follow the current H&P and update requirements (at §§ 482.22, 482.24, and 482.51) and will not choose to exercise this option in any way. Conversely, we also expect that some will choose to exercise this option fully and to the broadest extent possible while still remaining in compliance with the requirements finalized. We further expect that another significant subset of hospitals will fall somewhere in the middle in their policy decisions and will most likely elect to exercise this option within an even more narrow and stringent set of parameters than CMS is requiring here. The regulatory flexibility and framework of these final requirements will allow each hospital to establish and tailor its own policy parameters according to its specific patient populations, individual institutional needs and resources, and own medical staff recommendations as long as the policies and procedures established and implemented meet or exceed the requirements finalized in this rule. As finalized here, these requirements, while providing a hospital with an alternative and less burdensome approach to pre-surgical patient assessment, will also at the same time ensure that a hospital takes into consideration all patient safety factors and quality of care issues, such as the degree of complexity of the patient's medical condition as well as that of the planned procedure itself, when it establishes a process to identify those patients to whom such a policy would apply.

In response to the commenter who stated that, under this new option, the assessment of patients prior to surgery will be “shifted from one provider (the primary care physician or the surgeon) to another (the anesthesiologist),” we note that the Anesthesia services CoP contains a separate provision (separate and distinct from the H&P, update, and pre-surgical assessment requirements in the Surgical services CoP) that requires that a “. . . preanesthesia evaluation [be] completed and documented by an individual qualified to administer anesthesia . . .” and that it must be “. . . performed within 48 hours prior to surgery or a procedure requiring anesthesia services.” The anesthesiologist is responsible for this evaluation, but not for the H&P, update, and pre-surgical assessment requirements that we are finalizing here. While an anesthiologist could certainly qualify to perform any of these pre-surgical assessments, we expect the operating practitioner, who is also responsible for the pre-, intra-, and post-operative care of the patient and must be a physician (as defined in section 1861(r) of the Act), an oral and maxillofacial surgeon, or, in accordance with State law and hospital policy, another qualified licensed individual (who would most likely be a member of the operating practitioner's team, such as an NP or PA, and who, by extension, would also be responsible for the care of the patient) to perform the pre-surgical assessment as required in this final rule. If a hospital and its medical staff choose to establish policies and procedures that delineate the duties and responsibilities of any individual anesthiologist (or any individual qualified to administer anesthesia) to include performance of the pre-surgical assessments included under this rule, then the hospital would need to demonstrate that these pre-surgical assessments are separate and distinct from the pre-anesthesia evaluations of patients required at § 482.52. Furthermore, a hospital must also ensure that any such policies and procedures, which assign these pre-surgical assessment duties and responsibilities to an individual anesthiologist (or an individual qualified to administer anesthesia) as discussed here, are not only in accordance with State law, but are also consistent in this regard with the current standards of both anesthesia care and surgical care.

The comments regarding reimbursement requirements and rates for outpatient surgeries and procedures are outside the scope of the CoPs and this rule.

Comment:

A few commenters were concerned about compliance with the revised requirements if no clear and recognized guidelines or recommendations exist for pre-surgical patient assessment for specific classes of patients undergoing certain outpatient surgeries and procedures.

Response:

The revised requirements, which allow for the option of establishing a policy for identification of specific patients to whom the assessment requirements in § 482.22(c)(5)(iii) would apply, are conditioned upon a hospital and its medical staff demonstrating evidence that the specific parameters required in this final rule are met. A hospital and its medical staff should not include those classes of patients and those outpatient surgeries and procedures in its pre-surgical patient assessment policy if the hospital finds that it cannot meet the requirements we are finalizing at §§ 482.22(c)(5)(v), including the requirement that the medical staff must demonstrate evidence that its policy is based on nationally recognized guidelines and standards of practice for the assessment of specific types of patients prior to specific outpatient surgeries and procedures.

Final Rule Action:

We are finalizing the requirements in §§ 482.22, 482.24, and 482.51, with only minor modifications. Specifically, we are changing the term “oromaxillofacial surgeon” to the correct term of “oral and maxillofacial surgeon” where indicated.

Contact:

CAPT Scott Cooper, USPHS, 410-786-9465.

c. Medical Staff: Autopsies (§ 482.22(d))

We proposed to remove the requirement at § 482.22(d), which states that a hospital's medical staff should attempt to secure autopsies in all cases of unusual deaths and of medical-legal

and educational interest. The mechanism for documenting permission to perform an autopsy must be defined and there must be a system for notifying the medical staff, and specifically the attending practitioner, when an autopsy is being performed.

Comment:

Several commenters agreed with the proposal, which they stated would remove duplicative administrative work and allow hospitals to defer to State requirements when an autopsy is necessary. Many commenters, including national associations representing medical examiners and pathologists, disagreed with the removal of the requirement that a hospital's medical staff attempt to secure autopsies for unusual deaths or educational purposes. The commenters stated that hospitals should attempt to obtain family permission for autopsies related to deaths resulting from questions about efficacy of treatment, for educational purposes, or for issues of unintended outcomes of treatment or medical uncertainty and these commenters also expressed concern that the removal of this proposal would lead to a further reduction in an already low national autopsy rate.

However, many of these commenters stated that hospitals should not be required to attempt to obtain family permission, or perform autopsies, in cases of medical-legal interest. In those circumstances, the commenters stated, hospitals should report the death to, and consult with, the authority of their local medical examiner, coroner, or medicolegal death investigative authority.

Finally, one commenter requested that CMS specifically state that hospitals are not prohibited from performing autopsies.

Response:

We agree that hospitals should not attempt to secure autopsies in medical-legal cases without first contacting their State's medical examiner or medical authority, in accordance with their State's laws. We will defer to state law on this issue, since each State has their own standards and laws regarding the performance of autopsies for medical-legal purposes, and we therefore are removing this as a requirement in the CoPs for hospitals. Furthermore, we believe that it is appropriate to remove the duplicative and burdensome requirement that hospitals attempt to secure autopsies for other cases of unusual deaths or for educational interest. We clarify that removing this requirement would not prohibit hospitals from performing autopsies and we believe that hospitals will implement their own policies regarding autopsies. While we understand the commenter's concerns regarding the decline in the national autopsy rate, we disagree that the removal of this specific requirement will cause a measurable decrease in the autopsy rate, impact quality of care, or dissuade hospitals from performing autopsies. As commenters themselves have noted, there are various causes that may have contributed to the reduction in the autopsy rate including risk adversion due to litigation concerns and concerns about reimbursement rates, and we have no additional evidence that would lead us to the conclusion that the removal of this requirement would exacerbate these numbers. We therefore are finalizing our proposal to remove the requirements at § 482.22(d). Although we are finalizing our proposal, we note that the removal of this requirement should not be construed as a diminution of our support for hospitals continuing to perform autopsies for various purposes, and we encourage hospitals to establish policies regarding autopsies, where appropriate.

Comment:

A few commenters suggested that all hospital admissions require the patient (or his or her representative) to affirmatively allow or prohibit an autopsy in the event of death. One commenter also stated that autopsies should be required for any hospital death, unless explicitly rejected by next of kin.

Response:

Mandating that hospitals perform autopsies, or that hospitals ask permission to perform an autopsy upon a patient's admission, would be unduly burdensome to hospitals and contrary to the purpose of the CoPs, which establish baseline health and safety requirements. However, hospitals may choose to establish their own policy that would require patients or their representatives to permit or decline autopsies upon admission, if they believe such a requirement is appropriate. As we previously stated, there is no prohibition against autopsies and hospitals are free to enact policies regarding autopsies if they choose to do so.

Additionally, requiring hospitals to perform autopsies could potentially conflict with State and local laws regarding autopsies for medical-legal cases. For instance, certain State laws require that hospitals report deaths arising from medical-legal circumstances to their local medical examiner or other authoritative body, so that a determination can be made as to whether an autopsy must be performed.

Final Rule Action:

We are finalizing the proposal to remove § 482.22(d), without modification.

Contact:

Alpha-Banu Wilson, 410-786-8687.

d. Infection Control (§ 482.42)

We proposed a new standard at § 482.42(c), “Unified and integrated infection control program for multi-hospital systems.” Like the proposed requirements for a unified and integrated QAPI program, the proposed standard for infection control would allow that for a hospital that is part of a hospital system consisting of multiple separately certified hospitals subject to a system governing body legally responsible for the conduct of each hospital, such system governing body could elect to have a unified and integrated infection control program for all of its member hospitals after determining that such a decision was in accordance with all applicable State and local laws. The system governing body would be responsible and accountable for ensuring that each of its separately certified hospitals met all of the requirements of this section. Each separately certified hospital subject to the system governing body would have to demonstrate that the unified and integrated infection control program: (1) Was established in a manner that took into account each member hospital's unique circumstances and any significant differences in patient populations and services offered in each hospital; (2) established and implemented policies and procedures to ensure that the needs and concerns of each of its separately certified hospitals, regardless of practice or location, are given due consideration; (3) had mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed; and (4) designated a qualified individual(s) at the hospital with expertise in infection prevention and control to be responsible for communicating with the unified infection control program, for implementing and maintaining the policies and procedures governing infection control, and for providing infection prevention education and training to hospital staff.

Comment:

Most commenters supported the proposal to allow hospitals that are part of a multi-hospital system to have a unified and integrated infection control program. The proposed rule included a specific request for public comment on whether there are any other programs currently required under the CoPs for each separately certified hospital, beyond the QAPI and Infection control programs proposed here, that stakeholders believe would likewise be better managed under a system governing body legally

responsible for the conduct of each separately certified hospital. In response, we received comments asking CMS for further revisions to the CoPs, like those proposed for QAPI and infection control programs here (and with specific mention of revising the Nursing services CoP in this way), to allow for similar departmental and operational integration among hospitals within a multi-hosptial system with a single governing body. The commenters stated that expansion of this flexibility for other hospital services, departments, units, and programs would reduce operational burden for individual hospitals, ensure the proper level of staff expertise for member hospitals, and improve the quality and continuity of care for all patients served within the system. A few commenters also expressed appreciation for the expanded flexibility that this proposal would afford hospitals by reducing burden, increasing efficiencies, and eliminating the duplication of efforts.

One commenter encouraged CMS to apply this approach to situations when a multi-hospital system's providers have to fulfill additional requirements stemming from Medicaid or Medicare managed care plans or other external regulatory entities. The commenter suggested the mandated training related to the special needs plan models of care (42 CFR 422.101(f)(2)(ii)) as an example of how this could be applied. The commenter stated that a multihospital system with a unified infection control program as allowed under the requirements finalized in this rule, and that is also potentially participating in an ACO, would most certainly meet the Model of Care training requirement. This commenter also suggested an alternative approach where ACO participants would be deemed as meeting the Model of Care requirement for all other external regulatory entities by meeting the unified infection control program requirements finalized here.

Response:

We thank the commenters for their support. We believe that a hospital's governing body should be afforded the option of unifying and integrating the various member hospitals within their multi-hospital system into a unified infection control program. As we discussed for unified and integrated QAPI programs, such a model would incorporate each individual hospital's infection control program, which would enable increased efficiencies, innovations, provider flexibility, and allow for the dissemination of best practices for patient care while also potentially improving patient safety and outcomes. We also believe that a unified infection control model is a natural progression for a multi-hospital system that utilizes a system governing body (as allowed at § 482.12), a unified medical staff (as allowed at § 482.22), and a unified QAPI program (as finalized in this rule at § 482.12).

The comments and recommendations regarding the application of the unified infection control model and its CoP requirements to any additional requirements mandated by Medicare and Medicaid managed care plans or other external regulatory entities are outside the scope of the CoPs and this rule.

Final Rule Action:

We are finalizing the proposed requirements in § 482.42. Moreover, in addition to revisions proposed and finalized for the Hospital/CAH Innovation Rule regarding Antibiotic Stewardship Programs (ASPs) (now part of the Infection Prevention and Control CoP discussed in Section III.B.6. of this final rule and finalized here at § 482.42), we are finalizing changes to § 482.42 that will now address the designated and qualified individual(s) at the hospital responsible for communicating with the unified infection control program, for implementing and maintaining the policies and procedures governing infection control, and for providing infection prevention education and training to hospital staff with regard to the ASP as well. We are also making other minor modifications to this section to finalize changes proposed in the Hospital/CAH Innovation Proposed Rule. All of these changes are discussed later in Section III.B.6. of this final rule.

Contact:

CAPT Scott Cooper, USPHS, 410-786-9465.

e. Special Requirements for Hospital Providers of Long-Term Care Services (“Swing-Beds”) (§ 482.58(b)(1), (4), (5), and (8), and Identical CAH Requirements: § 485.645(d)(1), (4), (5), (6), and (7))

Hospitals providing swing-bed services must meet all of the requirements at 42 CFR part 482, which includes the swing-bed requirements at § 482.58 for patients receiving swing-bed services, and CAHs providing swing-bed services must meet all of the requirements at 42 CFR part 485, subpart F, which includes the swing-bed requirements at § 485.645 for patients receiving swing-bed services. The swing-bed requirements within the hospital and CAH CoPs include a subset of cross-referenced long-term care requirements contained in 42 CFR part 483, subpart B, for which hospital and CAH swing-bed providers are surveyed as they are for all of the CoPs in their respective programs. We have determined that some of the cross-referenced long-term care requirements for hospitals and CAH swing-bed providers are unnecessary and unduly burdensome, given their focus on “residents” and longer length of stays, which we believe are not relevant to swing-bed patients. Thus, we proposed to remove the following requirements: §§ 482.58(b)(1) and (c) and 485.645(d)(1) (incorporating long-term care facility requirements at § 483.10(f)(9)). Under our current regulations at § 483.10(f)(9), the resident has a right to choose to, or refuse to, perform services for the facility, and the facility must not require a resident to perform services for the facility. Regulations at §§ 482.58(b)(1) and 485.645(d)(1) incorporate this resident right by reference.

We expect hospital and CAH swing-bed providers who do offer patients the option of providing services for the facility to have current policies and procedures that reflect this policy that includes protocol for establishing an agreement between the two parties.

Comment:

Commenters universally supported the proposal to remove the provision requiring hospitals and CAH swing-bed providers to provide residents with the right to choose to, or refuse to, perform services for the facility, and not requiring a resident to perform services for the facility. As with the majority of the hospital and CAH swing-bed proposals, commenters noted that this requirement is unnecessary, the source of confusion, or is unduly burdensome.

Response:

We appreciate the comments received and continue to believe that this change is appropriate.

Final Rule Action:

We are finalizing this proposed change without revisions.

§§ 482.58(b)(4) and 485.645(d)(4) (incorporating long-term care facility requirements at § 483.24(c)):

The facility must provide, based on the comprehensive assessment and care plan and the preferences of each resident, an ongoing program to support residents in their choice of activities and the activities program must be directed by a qualified professional who is a qualified therapeutic recreation specialist or an activities professional. Patients receiving swing-bed services in a hospital or CAH are not long term residents of the facility and generally only receive swing-bed services for a brief period of time for transition after the provision of acute care services. We expect that for those patients who receive swing-bed services for an extended period of time, their nursing care plan—as required under § 482.23(b)(4) for hospitals and

§ 485.635(d)(4) for CAHs—is based on assessing the patient's nursing care needs and will support care that holistically meets the needs of the patient, taking into consideration physiological and psychosocial factors.

Comment:

The majority of commenters were supportive of the proposed removal of the requirement for hospital and CAH swing-bed providers to provide an ongoing program to support residents in their choice of activities and have an activities program that is directed by a qualified professional. As with the majority of the hospital and CAH swing-bed proposals, commenters noted that this requirement is unnecessary, the source of confusion, or is unduly burdensome due to the limited length of stay for most patients receiving swing-bed services. Commenters generally agreed that the activity needs of those patients who receive swing-bed services for an extended period of time would be met via the hospital and CAH nursing care plan requirements.

However, one commenter noted that in the event a swing-bed patient receives care for an extended period of time, the nursing care plan will not include interest-based group and individual activities that support the patient's physical, mental and psychosocial well-being. The commenter noted that therapeutic or recreational activities differ significantly from the goals that normally would be identified in a nursing care plan.

Response:

We appreciate the comments received and continue to believe that this change is appropriate. It is expected that hospitals and CAHs, using an interdisciplinary approach, are providing services that meet the needs of all of their patients, including those receiving swing-bed services, regardless of their length of stay. In addition, nursing care plans are intended to provide direction on the type of nursing care the needed by the patient, stemming from the patient's diagnoses, that is organized based on the specific needs of the patient. The care plan is dynamic and should change as the needs of the patient change. As a result, if the needs of the patient include interest-based group and individual activities that support the patient's physical, mental and psychosocial well-being, we expect that the hospital or CAH will provide these services to the patient.

Final Rule Action:

We are finalizing this proposed change without revision.

§§ 482.58(b)(5) and 485.645(d)(5) (incorporating long-term care facility requirements at § 483.70(p)):

Any facility with more than 120 beds must employ a qualified social worker on a full-time basis.

In accordance with the hospital and CAH swing-bed requirements, hospital swing-bed providers are not permitted to have more than 100 beds while CAH swing-bed providers are not permitted to have more than 25 beds for the provision of inpatient or swing-bed services. Based on feedback from stakeholders, removing this requirement would eliminate confusion for providers and accreditation organizations.

Comment:

Commenters universally supported the proposal to remove the provision requiring hospitals and CAH swing-bed providers with more than 120 beds to employ a full-time social worker. As with the majority of the hospital and CAH swing-bed proposals, commenters noted that this requirement is unnecessary, the source of confusion, or is unduly burdensome.

Response:

We appreciate the comments received and continue to believe that this change is appropriate.

Final Rule Action:

We are finalizing this proposed change as proposed.

§§ 482.58(b)(7) and 485.645(d)(7) (incorporating the long-term care facility requirement at § 483.55(a)(1)):

Under our long-term care facility requirements, the facility, must provide routine and emergency dental services to meet the needs of each resident, or obtain them from an outside resource, in accordance with § 483.70(g).

Hospitals and CAHs are required to provide care in accordance with the needs of the patient that have been identified in such patients' plans of care; this could include non-emergency dental care. We expect that hospital swing-bed providers are currently addressing the emergent dental care needs of their patients under the existing hospital CoP at § 482.12(f)(2), which requires that hospitals have written policies and procedures for appraisal of emergencies, initial treatment, and referral when appropriate. Similarly, we expect that CAH swing-bed providers are currently addressing the emergent dental care needs of their patients under the existing emergency services CoP at § 485.618, which requires CAHs to provide emergency care necessary to meet the needs of its inpatients and outpatients. As a result, we believe that this portion of the requirement is duplicative, given the current CoP requirements.

Comment:

Commenters universally supported the proposal to remove the provision requiring hospitals and CAH swing-bed providers provide or obtain from an outside resource routine and emergency dental services to meet the needs of each resident. As with the majority of the hospital and CAH swing-bed proposals, commenters noted that this requirement is unnecessary, the source of confusion, or is unduly burdensome.

In addition, the most recent guidelines from the American Dental Association note that patients should have regular dental visits, with the frequency determined by their dentist to accommodate for the patients' current oral health status and health history (American Dental Association,

https://www.ada.org/en/press-room/news-releases/2013-archive/june/american-dental-association-statement-on-regular-dental-visits

).

Response:

We appreciate the comments received and continue to believe that this change is appropriate.

Final Rule Action:

We are finalizing this proposed change as proposed.

Contact:

Kianna Banks, 410-786-3498.

f. Special Requirements for Psychiatric Hospitals (§ 482.61(d))

We believe that as currently written and implemented, this requirement requires clarification regarding the language that progress notes “must be recorded by the doctor of medicine or osteopathy responsible for the care of the patient as specified in § 482.12(c), nurse, social worker and, when appropriate, others significantly involved in active treatment modalities.” We believe that non-physician practitioners, including physician assistants, nurse practitioners, psychologists, and clinical nurse specialists, when acting in accordance with State law, their scope of practice, and hospital policy, should have the authority to record progress notes of psychiatric patients for whom they are responsible. Therefore, we proposed to allow the use of non-physician practitioners or MD/DOs to document progress notes of patients receiving services in psychiatric hospitals.

Comment:

Commenters were mostly supportive of the proposal to clarify the documentation requirements for recording progress notes in the patient's medical records for patients receiving services in psychiatric hospitals. Commenters noted that the proposed change would reduce barriers for care providers and will give non-physician practitioners expanded access to document the provision of the health care to patients, resulting in improved continuity of care.

Response:

We appreciate the comments received and continue to believe that this change is appropriate.

Comment:

One commenter opposed the proposed change, noting that the existing regulatory language already permits non-physician practitioners to document progress notes in the patient's medical records for patients receiving services in psychiatric hospitals; therefore, the change would be unlikely to produce costs savings from incorporating psychologists or other licensed practitioners in this requirement. Another commenter opposed the inclusion in the proposed rule of psychologists in the list of non-physician practitioners allowed to document the patient's progress notes. The commenter notes that the current regulations permit psychologists to document the services they provide (psychotherapy, psychological/neuropsychological testing notes), but they should not be granted the authority to write medical progress notes due to the current Medicare regulations under § 482.12(c)(1)(vi).

Response:

While we agree with the commenter regarding the intent of the current regulatory language, we believe that there is a need to clarify the intent of the language and ensure that the healthcare providers with the authority to document the progress reports are clearly identified. The majority of commenters supported the need for clarification due to the failure of the regulatory text to specify the non-physician practitioners who could document progress reports.

Additionally, we believe psychologists are appropriately included in the list of non-physician practitioners who have the authority to document in progress notes for patients receiving services in psychiatric hospitals. The regulation at § 482.12(c)(1)(vi), referenced by the commenter, states that a clinical psychologist, as defined in § 410.71, has the authority to admit patients and oversee the care of Medicare patients (but only with respect to clinical psychologist services as defined in § 410.71 of this chapter and only to the extent permitted by State law). Furthermore, non-physician practitioners currently document in the progress notes of patients in acute care hospitals to the extent of their scope of practice and hospital policy.

We believe that the revised language in this final rule will clarify our original intent in the proposed rule (as understood by readers as evidenced by the comments discussed here that request and support such clarification on this issue) that non-physician practitioners, including physician assistants, nurse practitioners, psychologists, and clinical nurse specialists, when acting in accordance with applicable State scope of practice laws, and hospital policies, should have the authority to record progress notes for all psychiatric and medical problems, which are present upon patient admission or which develop during hospitalization, for any psychiatric patient for whom these licensed practitioners are responsible as long as such patient problems fall within the bounds of a licensed practitioner's specific State scope of practice laws and hospital policies.

Comment:

One commenter requested that clarification be provided regarding the use of the phrase “hospital policy” as it relates to the requirement that non-physician practitioners act in accordance with hospital policy.

Response:

Psychiatric hospitals must comply with the hospital CoPs under 42 CFR part 482, which includes the requirements for psychiatric hospitals. The hospital CoPs require that the hospital's governing body approve all hospital policies, and in accordance with § 482.12(a)(4), the governing body must determine (in accordance with State law) which categories of practitioners are eligible candidates for appointment to the medical staff. The governing body is required to appoint members of the medical staff after considering the recommendations of the existing members of the medical staff and approve medical staff bylaws and other medical staff rules and regulations. Non-physician practitioners, whether employees or contractors, would be subject to all rules, regulations, and policy manuals utilized by the hospital.

Final Rule Action:

We are finalizing the changes as proposed.

•

Contact:

Kianna Banks, 410-786-3498.

5. Transplant Centers

a. Special Requirement for Transplant Centers (§§ 482.68 and 482.70)

We proposed to update the terminology within the hospital regulation at part 482 and the transplant regulations at §§ 482.68, 482.70, 482.72 through 482.104, and at § 488.61, for clarification and consistency. Specifically, we proposed a nomenclature change which would:

• Replace the term transplant “center” in the regulation language with transplant “program” (each organ type would be a transplant program). A transplant program is located within a transplant hospital that provides transplantation services for a particular type of organ. Since individual transplant programs are surveyed for compliance with the CoPs, using the term transplant program throughout the regulation better aligns with current surveyor practice and will reduce provider confusion. In order to provide further clarity, we also proposed to update the definitions at § 482.70.

• Consistently use Independent Living Donor Advocate (ILDA) throughout the regulation.

• Change “beneficiaries” to “recipients”.

Comment:

All comments we received expressed support for the proposed nomenclature change, which would make the terminology used in the regulations consistent with the terminology used by the Organ Procurement and Transplantation Network (OPTN) and the transplant community.

Response:

We thank the commenters for their support. We are finalizing this proposal without modification.

b. Data Submission, Clinical Experience, and Outcome Requirements for Re-Approval of Transplant Centers (§ 482.82)

We proposed to remove the requirements at § 482.82 that require transplant centers to submit data (including, but not limited to, submission of the appropriate OPTN forms for transplant candidate registration, transplant beneficiary registration and follow-up, and living donor registration and follow-up), clinical experience, and outcome requirements for Medicare re-approval, and make conforming changes to § 482.102(a)(5) “Condition of participation, Patient and living donor rights” and § 488.61 “Special Procedures for Approval and Re-Approval of Organ Transplant Centers.”

Comment:

Most commenters, including several major organizations which represent the interests of transplant surgeons and other professionals, transplant patients, individual transplant programs, members of the transplant community, and the OPTN, strongly supported the proposal to remove the provision that requires transplant centers that are applying for Medicare re-approval to meet all data submission, clinical experience, and outcome requirements in order to be re-approved. These commenters agreed with our analysis of the unintended consequences that have occurred because of the Medicare re-approval requirements and many agreed that eliminating this requirement would improve transplantation in the United States. Many of these commenters also stated their belief that the proposal would reduce administrative burdens. A

few commenters also supported maintaining the requirements for initial Medicare approval for transplant centers.

Several commenters, including members of the transplant community and interested individuals, objected to the removal of this proposal. These commenters as a whole were concerned that removing this proposal would affect quality of care and patient outcomes. Specifically, commenters were concerned as to whether information on transplant centers outcomes would continue to be available to the public, and whether CMS would still be able to identify underperforming transplant programs, in order to ensure patient safety and continued positive outcomes. Other commenters stated that, absent these requirements, CMS would rely upon transplant programs notifying CMS of changes rather than having a process in place that would monitor such changes. A few commenters expressed concerns regarding how CMS would identify underperforming transplant programs and requested guidance as to how CMS plans to ensure patient safety and positive outcomes by using the QAPI program instead of the current re-approval process. Others requested clarification as to how CMS would continue to monitor outcomes absent this requirement.

Response:

We appreciate the commenters' support. CMS is committed to ensuring that our regulations support a patient's access to lifesaving organs. We also strive to protect the quality of care that the transplant recipient and donor receives while in the transplant facility and we agree with commenters that the removal of this requirement will work towards achieving these goals. We appreciate the numerous studies and professional opinions that were submitted by the public that further bolstered our understanding of the unintended consequences that have occurred as a result of the Medicare re-approval requirements for transplant centers and we therefore are finalizing our proposal to remove these requirements at § 482.82. We believe that the removal of these requirements will lead to improved patient outcomes, increased transplantation opportunities for patients on the waitlist, improved organ procurement for transplantation, greater organ utilization, and reduced burden on transplant programs. We note that the removal of these requirements directly aligns with our goal to increase access to kidney transplants by increasing the utilization of available organs from deceased donors and reducing the organ discard rate, which we outline in the Advancing American Kidney Health Paper, which can be found on the Office of the Assistant Secretary for Planning and Evaluation website at

https://aspe.hhs.gov/pdf-report/advancing-american-kidney-health.

We understand the concerns that commenters raised regarding the availability of transplant program outcome data and we remind commenters that transplant outcomes will still be available to the public every six months on the Scientific Registry for Transplant Recipients (SRTR) website at

https://www.srtr.org/.

In addition, CMS will continue to survey the program's QAPI program to make sure the program is tracking adverse events, performing thorough analysis of each adverse event, and that performance improvement projects ensure adverse events do not recur. CMS will also do complaint investigations based on public or confidential reports about outcomes or adverse events.

It is our expectation that transplant programs will use their QAPI programs to continue to monitor quality of care, evaluate transplantation activities and outcomes, and conduct performance improvements when necessary. We believe that these efforts and the survey of the CoPs provides sufficient oversight to ensure that transplant programs will continue to achieve and maintain high standards of care.

Comment:

A few commenters, who were generally supportive of the proposals, had additional clarifying questions for CMS about the survey process. One commenter asked whether additional reporting on the part of the hospital and transplant based QAPI programs would be required. A few commenters asked whether CMS would monitor hospital and QAPI based programs through a different mechanism, while one comment asked whether CMS will be providing published information regarding these reviews. One commenter also expressed their opposition to a change to the transplant QAPI regulations, and they expressed concern that changing these regulations will have unintended negative consequences on transplant survival outcomes, safety issues, and an increased focused on transplant volume by programs. Another commenter asked the following questions:

• Whether the monitoring schedule for CMS surveys of transplant programs will remain the same;

• What circumstances will trigger a review from CMS outside of routine recertification surveys; and

• What options will be available to a transplant program with condition level deficiencies on recertification surveys once the mitigating factors and SIAs are removed.

Response:

We did not propose changes to the transplant program QAPI requirements and, consistent with other provider types, there is no public reporting for the hospital and transplant QAPI programs. Transplant programs must continue to abide by the hospital and transplant program QAPI CoPs at §§ 482.21 and 482.96, respectively. On survey, documentation of communication between these QAPI entities is expected and the hospital QAPI program should report to the Governing Body any issues with transplant outcomes.

In response to the questions about the survey process, we note that the survey interval will not change, and that public or confidential reports may trigger a complaint survey. Mitigating factors and systems improvement agreements were for outcomes non-compliance only and are therefore unnecessary with the removal of the outcomes re-approval requirement at § 482.82.

Comment:

A few commenters were generally supportive of CMS's goals to improve organ transplantation by removing provider disincentives, but the commenters suggested that this could be achieved through improvements to the quality and outcomes measures. Specifically, the commenters suggested that reported outcomes focus on long term outcomes instead of short term outcomes, data on waitlist survival, donor utilization, total volume of organs transplanted, transplant rate utilization, cost-effectiveness, and other quality of care measures.

Response:

We believe that the wide variety of data and studies presented in the proposed rule regarding the unintended consequences of the re-approval requirements sufficiently demonstrates that it is no longer appropriate to include specific outcome measures as a requirement for Medicare re-approval. Transplant programs, however, will still need to abide by these outcome measures for initial Medicare approval.

Comment:

One commenter opposed the transplant center proposals and suggested that CMS look at Organ Procurement Organization (OPO) performance in producing quality organs.

Response:

We thank the commenters for their feedback regarding OPO performance measures. However, we note that comments regarding OPOs are outside the scope of this final rule.

c. Special Procedures for Approval and Re-Approval of Organ Transplant Centers (§ 488.61(f) Through (h))

We proposed to remove the requirements at § 488.61(f) through (h) for mitigating factors and transplant systems improvement agreements for the re-approval process for transplant centers. This change is complementary to the proposed removal of § 482.82, described previously.

Comment:

The majority of commenters were supportive of the proposal to remove the mitigating factors and systems improvement agreements requirement for the re-approval process for transplant centers. These commenters stated that the removal of this requirement will relieve undue burden on transplant programs. However, a few commenters opposed the removal of this provision. The commenters were concerned that the removal of this provision would negatively impact programs and they noted that programs that failed to meet the re-approval requirements would be terminated, which would limit patient access. The commenter suggested that, if this proposal is finalized, CMS should monitor the number of programs that have been decertified or that will face decertification based on conditions.

Response:

The proposed change to remove the mitigating factors and systems improvement agreements afforded to transplant centers for Medicare re-approval is a complementary change to the removal of the Medicare re-approval requirements in § 482.82. We are finalizing the removal of § 482.82, making the existence of the mitigating factors and systems improvement agreement requirements obsolete. However, we note that transplant programs are still afforded the opportunity to submit mitigating factors or enter into systems improvement agreements for the initial Medicare approval, and that we are not making additional changes to the current processes other than the provisions regarding mitigating factors and systems improvement agreements.

Final Rule Action:

1. We are finalizing the proposal to make nomenclature changes throughout the transplant center regulations at §§ 482.68, 482.70, 482.72 through 482.104, and at § 488.61, without modification.

2. We are finalizing the proposal to remove § 482.82, without modification.

3. We are finalizing the proposal to remove the mitigating factor and systems improvement agreement requirements for Medicare re-approval at § 488.61(f) through (h), without modification.

Contact:

Alpha-Banu Wilson, 410-786-8687.

6. Home Health Agencies

We received 27 timely public comments on our proposed changes to the HHA requirements. Commenters included industry associations, healthcare systems, individual HHAs, consumer advocacy organizations, and clinicians. Overall, the majority of commenters were supportive of the goal of the proposed changes. Those comments are discussed below.

a. Patient Rights (§ 484.50(a)(3) and (c)(7))

We proposed to delete the requirement at § 484.50(a)(3) that HHAs must provide verbal notification of all patient rights. We proposed to limit the verbal notification requirements to those requirements set out in section 1891(a)(1)(E) of the Act for which verbal notification is mandatory. We proposed to revise § 484.50(c)(7) to implement this more limited verbal notification requirement. Revised § 484.50(c)(7) would require HHAs to verbally discuss HHA payment and patient financial liability information with each HHA patient as described above.

Comment:

The majority of comments submitted regarding this topic expressed support for the proposed change to require written notice of patient rights for all enumerated rights, and oral notice only for those rights specifically set forth in the Act as requiring such oral notice. However, a small number of comments did not support this change, stating that oral notice of all rights, rather than only those set forth in the Act, has value to patients and caregivers. One commenter stated that oral notice is particularly important for individuals with lower literacy levels due to disabilities.

Response:

Consistent with the notice of patient rights requirements for other outpatient provider types, such as hospices, ambulatory surgery centers, and community mental health centers, for which written notice of patient rights is the only requirement, and in light of the support for this proposed change expressed by the majority of commenters, we are finalizing this change. We are sensitive to concerns related to those individuals with lower literacy levels due to disabilities that may impact understanding of the notice of patient rights. We remind all HHAs that, as part of their Medicare provider agreements, and in accordance with the other requirements of § 484.50, they are responsible for complying with the provisions of the Americans with Disabilities Act and Section 504 of the Rehabilitation Act when communicating with all patients regarding all subjects, including the notice of patient rights. HHAs must provide equal access to individuals with disabilities, including the provision of auxiliary aids and alternate formats, including, but not limited to, the provision of qualified interpreters, large print documents, Braille, digital versions of documents, and audio recordings.

b. Home Health Aide Services (§ 484.80(h)(3))

We proposed to eliminate the requirement at § 484.80(h)(3) that HHAs conduct a full competency evaluation of home health aides, and replace it with a requirement to retrain the aide regarding the identified deficient skill(s) and require the aide to complete a competency evaluation related only to those skills.

Comment:

Comments overwhelmingly supported the proposed change to remove the requirement that a home health aide must complete a full competency evaluation whenever a skill deficiency is noted during the aide supervision process.

Response:

We continue to believe that this change is appropriate, and are finalizing it as proposed.

c. Clinical Records (§ 484.110(e))

We proposed to remove the requirement at § 484.110(e) that the requested clinical record copy must be provided at the next home visit, while retaining the requirement that the information must be provided within 4 business days.

Comments:

Comments universally supported the proposal to remove the requirement that HHAs must provide to patients a copy of information contained in the clinical record by the time of the next HHA visit. A few comments explicitly supported maintaining the requirement to provide the requested information to patients within 4 days. However, other comments stated that the proposed change did not provide enough burden relief, and suggested that the requirement to provide a copy of such information within 4 days should also be revised to allow HHAs up to 30 calendar days to provide such information. Commenters stated that 4 business days was insufficient time to access records, which may be archived offsite, make copies, and send those copies in the mail to arrive within 4 business days at the patient's home. One comment stated that the regulations should not include any requirements for HHAs to provide patients with

information from their own clinical records. Other commenters suggested that a shorter timeframe for providing information could be limited to only the information from the current 60 day episode of care, rather than to all certification periods from the episode of care or the patient's entire record of care that may cross several different episodes of care. Additionally, some commenters stated that HHAs should be permitted to charge patients a fee for providing information from the patient's own clinical record. However, other commenters specifically supported the prohibition on charging patients a fee to receive information from their own records.

Response:

We appreciate the commenters' support for our proposed revisions, and for their suggestions for further changes regarding the HHA clinical records provisions. Addressing the evolving need for the electronic exchange of health information amongst health care providers and also between patients and their health care providers is an Administration priority. As such, we will consider the issues raised by commenters in the broader context of interoperability and health information exchange, and will use these comments to inform future rulemaking. We are not finalizing the changes to § 484.110(e) at this time.

d. Additional Comments

Summaries of the additional suggestions that we received that are not directly related to our proposals and our responses are set forth below.

Comment:

Several commenters suggested that the requirement for HHAs to provide certain specified information, such as the upcoming HHA visit schedule and information about the treatments being furnished by HHA clinicians (§ 484.60(e)) in writing to patients, should be completely removed or significantly revised to remove most of the specified information from the list. Commenters specifically cited the requirement to provide patients with a visit schedule, contact information for a hospice clinical manager, and information about the treatments being provided as being overly burdensome requirements.

Response:

While we understand the concerns expressed by commenters, we continue to believe that providing patient-centered, patient-directed care necessitates the provision of this crucial information to all patients. Patients cannot be active participants in their own care and advocates for their own interests without having essential information about when care will be provided to them, what treatments are being (or are supposed to be) administered during their care, and information for how to contact a clinical member of the HHA care team to discuss their questions and concerns. While it may be challenging for HHAs to keep patients abreast of their own care, such efforts form the basis of patient-centered care and cannot be ignored.

Comment:

A commenter suggested that the CoP for the comprehensive assessment should be revised to permit a registered nurse or a therapist to perform the comprehensive assessment in all cases where both services are ordered. A few commenters suggested that HHAs should not be required to provide any clinical services by their own employees, per the requirements of § 484.105(f), and should instead be allowed to provide all clinical services under arrangement.

Response:

Changes of this magnitude would mark a significant departure from longstanding CMS policy. As such, we believe that it would be most appropriate to use the traditional notice and comment rulemaking process to allow all interested parties the opportunity to comment on the concepts. We will take these suggestions under consideration for future rulemaking efforts.

Comment:

Several commenters stated that nurse practitioners, in addition to physicians, should be allowed to write orders for the home health plan of care and provide care plan oversight.

Response:

Section 1861(m) of the Act requires the HHA plan of care to be under the direction of a physician. Section 1861(r) of the Act defines “physician” in a manner that does not include other licensed practitioners, such as nurse practitioners and physician assistants. Therefore, pursuant to statute, other licensed practitioners may not establish and maintain the home health plan of care, including reviewing, signing, and ordering services on the home health plan of care.

Comment:

A few commenters submitted comments related to physician signatures and communication with physicians regarding orders and the plan of care. Some comments stated that a physician signature should not be required for therapy orders. The commenters stated that requiring a physician signature on such orders delays the initiation of therapy services. Another comment stated that HHAs should not be required to communicate with all physicians who write orders for the plan of care when there is a change in the plan of care.

Response:

In order to maintain appropriate oversight of the HHA plan of care, all HHA services, including therapy services, must be ordered by a physician (§ 484.60(b)(1)). The CoPs allow for verbal orders in order to facilitate a timely initiation of care, requiring that verbal orders be authenticated and dated by the physician in accordance with applicable state laws and regulations, and consistent with the HHA's own internal policies. Typically, a physician writes orders for a therapist to evaluate and treat the patient. The requirement for the physician order and subsequent signature in accordance with State law and HHA policy would not delay therapy services after the therapist's evaluation and recommended treatment plan has been communicated to the physician for approval. It is not necessary to withhold therapy services while waiting for the physician confirmation of the therapy plan.

We agree with the commenter that communicating with all involved physician(s) is not necessary for every single change in the plan of care. Section 484.60(c)(3) requires such communication only when the change to the plan of care is due to a change in the patient's health status (for example, initiating a new medication) or a change in the plan for the patient's discharge from the HHA. The communication of other changes that do not fall into one of these categories (for example, adjusting the dose of a current medication) is left to the discretion of HHA clinical staff and the clinical manager(s) responsible for the patient's care.

Comment:

Numerous commenters submitted suggestions for changes to HHA payment policies, such as the face to face requirement and the homebound requirement, which they believe should be addressed as part of CMS burden reduction efforts. A single commenter suggested a revision to the Home Health Consumer Assessment of Healthcare Providers and Systems (HHCAHPS). A small number of commenters submitted comments regarding information in the HHA interpretive guidelines.

Response:

Comments not related to the HHA CoPs are outside of the scope of this rule. Individuals wishing to submit comments regarding CMS payment policies may submit those comments as part of the annual HHA payment policy proposed rule. We have shared these unrelated comments with the appropriate components within CMS.

Final Rule Action:

1. We are finalizing the proposal to delete the requirement at § 484.50(a)(3)

that HHAs must provide verbal notification of all patient rights.

2. We are finalizing the proposal to revise § 484.50(c)(7), requiring HHAs to verbally discuss HHA payment and patient financial liability information with each HHA patient.

3. We are finalizing the proposal to eliminate the requirement at § 484.80(h)(3) to conduct a full competency evaluation, and replace it with a requirement to retrain the aide regarding the identified deficient skill(s), and require the aide to complete a competency evaluation related only to those skills.

4. We are not finalizing the proposal to remove the requirement at § 484.110(e) that the requested clinical record copy must be provided at the next home visit.

Contact:

Danielle Shearer, 410-786-6617.

7. Comprehensive Outpatient Rehabilitation Facilities (CORFs)—Utilization Review Plan (§ 485.66)

We proposed to amend the utilization review plan requirements at § 485.66 to reduce the frequency of utilization reviews from a quarterly basis to an annual requirement.

We received two timely public comments on our proposed changes to the CORF requirements. Both comments expressed strong support for the proposed changes; therefore we are finalizing those changes as proposed in this final rule.

1.

Final Rule Action:

We are finalizing

the proposal to revise § 485.66, requiring the facility to have a written utilization review plan that is implemented annually, without modification.

Contact:

CAPT Jacqueline Leach, USPHS, 410-786-4282.

8. Critical Access Hospitals

a. Organizational Structure (§ 485.627(b)(1))

We proposed to remove the requirement for CAHs to disclose the names and addresses of their owners, those with a controlling interest in the CAH or in any subcontractor in which the CAH directly or indirectly has a 5 percent or more ownership interest, in accordance with 42 CFR part 420, subpart C. This requirement is duplicative, as it is also a requirement for the provider agreement for Medicare participation. This proposal was also included in the

Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care; Proposed Rule

(81 FR 39447) for the same reason.

Comment:

Commenters universally supported the proposal to remove the CAH disclosure requirement, noting that the requirement duplicates a provision found elsewhere in our regulations. Comments received regarding this provision in the

Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care; Proposed Rule

(81 FR 39447, 39460, June 16, 2016) were consistent with those received for this proposed rule, with commenters also universally supporting the proposal.

Response:

We appreciate the comments received and continue to believe that this change is appropriate.

Final Rule Action:

We are finalizing the proposed changes without modification.

Contact:

Kianna Banks, 410-786-3498.

b. Provision of Services (§ 485.635(a)(4))

Current regulations at § 485.635 require a CAH's professional healthcare staff to review policies and procedures annually; the review group must include one or more doctors of medicine or osteopathy and one or more physician assistants, nurse practitioners, or clinical nurse specialists. Based on our experience with other providers, we proposed a flexible approach that would allow CAHs to maintain their health and safety policies in such a manner as to achieve the intended outcomes for all patients. Thus, we proposed to change the requirement at § 485.635(a)(4) from “annual” to “biennial”.

We received 20 public comments on our proposed changes to this CAH requirement. Commenters included hospital industry associations, individual providers, and national accrediting organizations. Overall the commenters were supportive of the proposed changes.

Summaries of the comments and our responses are set forth below.

Comment:

All of the commenters agreed with the effort to reduce burden. However, a few of commenters suggested moving to a 3-year timeframe for reviews and several other commenters suggested aligning with hospital requirements and removing the timeframe and allow CAHs to determine when reviews are done.

Response:

CAHs are rural providers with separate Conditions of Participation from hospitals and they do not have the range or number of personnel, among other requirements we require for hospitals.

We believe that the approach of requiring a biennial review reduces burden while maintaining the appropriate safeguards for healthy outcomes for CAH patients. Therefore, we are finalizing this requirement without modification.

Final Rule Action:

We are finalizing the proposed changes to § 485.635(a)(4).

Contact:

Mary Collins, 410-786-3189.

c. Special Requirements for CAH Providers of Long-Term Care Services (“Swing-Beds”) (§ 485.645(d)(1), (4), (5) and (8))

The special requirements for CAH swing-bed providers are nearly identical to the requirements for hospital providers of swing-bed services. As a result, please refer to the discussion on the special requirements for hospital providers of swing-bed services under section II.D.3 for the details of the proposed changes for these requirements for both hospitals and CAHs. We proposed the following revisions to the CAH swing-bed requirements:

• Revision of § 485.645(d)(1) to remove the cross-referenced long-term care requirement in § 483.10(f)(9), which requires that CAH swing-bed providers to offer residents the right to choose to or refuse to perform services for the facility and prohibits a facility from requiring a resident to perform services for the facility;

• Removal of § 485.645(d)(4), which requires CAH swing-bed providers to provide an ongoing activity program that is directed by a qualified therapeutic recreation specialist or an activities professional who meets certain requirements (cross-referenced long-term care requirement § 483.24(c));

• Revision of § 485.645(d)(4) (as redesignated) to remove the cross-referenced long-term care requirement § 483.70(p), which requires that CAH swing-bed providers with more than 120 beds to employ a qualified social worker on a full-time basis; and

• Revision of § 485.645(d)(7) (as redesignated) to remove the cross-referenced long-term care requirement § 483.55(a)(1), which requires CAH swing-bed providers to assist in obtaining routine and 24-hour emergency dental care to its residents.

Contact:

Kianna Banks, 410-786-3498.

9. Community Mental Health Centers (§ 485.914(d))

We require CMHCs, at § 485.914(d)(1), to update clients' comprehensive assessments every 30 days. We proposed to revise § 485.914(d)(1) to require that the CMHC update each client's comprehensive assessment via the CMHC interdisciplinary treatment

team, in consultation with the client's primary health care provider (if any), when changes in the client's status, responses to treatment, or goal achievement have occurred, and in accordance with current standards of practice. Additionally, at § 485.914(d)(2), we proposed to retain the minimum 30-day assessment update time frame for those clients who receive PHP services. We believe this proposed change will allow for the provider and client to choose a visit schedule that is appropriate for the client's condition and not cause extra work or time for documentation that is unnecessary. Ultimately, this proposed change may allow for greater flexibility for the provider and client, saving time for both.

We received 4 timely public comments on our proposed changes to the requirements at § 485.914(d). Commenters included physicians, associations and health networks. Overall, the majority of commenters were supportive of the goal of the proposed changes. Summaries of the major issues and our responses are set forth below.

All of the comments expressed strong support for the proposed changes to § 485.914(d); therefore, we are incorporating those changes as proposed in this final rule.

Comment:

We received several comments in support of the proposed change to the CMHC update to the comprehensive assessment requirement. Most commenters agreed that, for patients admitted for non-PHP services, it made sense to allow patients care needs, responses to treatment and care goals to drive decisions about when a patient needs to have an updated assessment. Commenters also agreed that it was appropriate to keep the requirement to update to the comprehensive assessment every 30 days for PHP patients. One commenter raised a concern regarding the proposed update to the comprehensive assessment requirement changes as it relates to patients needing to transfer to the hospital emergency department. The commenter stated that some emergency departments receive patients directly from CMHCs for emergency mental health treatment, and that it is important for the treating physician in the ED to know what medications the patient is taking. A commenter agreed with the proposed change to the comprehensive assessment update requirement, and asked for CMS to consider making similar burden reducing changes to all the requirements for the ”Persons centered active treatment plan” under § 485.916.

Response:

We appreciate all of the positive feedback on the proposed changes to remove the 30-day updated assessment timeframe for non-PHP patients, and are finalizing this proposal without change. We understand the concerns raised related to how this assessment change would impact CMHC patients who must be transferred to a hospital emergency room. In the CMHC CoPs under § 485.914(e)(5)(v)(A)-(E), we state that when a client becomes an immediate threat to the physical safety of themselves, staff or other individuals, the CMHC must document a description of the client's behavior and the intervention(s) used (including medications), alternatives or other less restrictive interventions attempted, the client's condition or symptom(s) that warranted the use of the restraint or seclusion, and the client's response to the intervention(s) used. Typically, patient transfers from a CMHC to an emergency room include a transfer note summarizing the above information, including all current medications and any PRN medications that were given prior to the transfer to the emergency room. Furthermore, we agree with the suggestion that conforming changes should be made to § 485.916, because the requirements of § 485.914 and 485.916 constitute a cycle of care, with assessment and care planning feeding into one another. However, because we did not propose any changes to the client centered active treatment plan CoP (§ 485.916), we are legally not permitted to make any changes in a final rule without proposing the change to the public in a proposed rule. Therefore we will not be amending the regulatory language in § 485.916 but will consider proposing a change to the requirements at a future date.

Final Rule Action:

We are finalizing the proposal to revise § 485.914(d) that the CMHC must update each client's comprehensive assessment via the CMHC interdisciplinary treatment team, in consultation with the client's primary health care provider (if any), when changes in the client's status, responses to treatment, or goal achievement have occurred and in accordance with current standards of practice. For clients that receive PHP services, the assessment must be updated no less frequently than every 30 days.

Contact:

CAPT Mary Rossi-Coajou, USPHS, 410-786-6051.

10. Portable X-Ray Services (§§ 486.104(a) and 486.106(a))

We proposed to revise the personnel qualification requirements at § 486.104(a)(1), (2), (3), or (4) by removing school accreditation requirements and simplifying the structure of the requirements. We proposed that all operators of portable X-ray equipment would meet one of the following:

(1) Successful completion of a program of formal training in X-ray technology at which the operator received appropriate training and demonstrated competence in the use of equipment and administration of portable x-ray procedures; or

(2) Successful completion of 24 full months of training and experience under the direct supervision of a physician who is certified in radiology or who possesses qualifications which are equivalent to those required for such certification.

We proposed to update § 486.106(a)(2) (specific to portable x-ray services) to cross reference the requirements at § 410.32 instead of setting forth specific order requirements. We proposed to retain the requirement that the portable x-ray order must include a statement on why it is necessary to perform a portable x-ray as opposed to performing the study in a facility where x-rays are more typically performed.

We received 9 timely public comments on our proposed changes to the portable x-ray requirements. Commenters included long-term care facility associations, portable x-ray associations, portable x-ray suppliers, and health care systems. Overall, the majority of commenters were supportive of the goal of the proposed changes. Summaries of the major issues and our responses are set forth below.

Comment:

All of the comments received regarding our proposal to revise the personnel requirements for individuals who perform portable x-ray services supported the proposed revision. A single commenter suggested that option 2, related to 24 full months of training and experience under the direct supervision of a physician, and should not be included because these training programs are no longer offered.

Response:

We agree with the comments that it is appropriate to revise the personnel requirements for individuals who perform portable x-ray services in a manner that focuses on the skills of the individual rather than the accreditation of the institution that provided the training, and we are finalizing this change. We do not agree that it is appropriate to eliminate the qualification option related to 24 full months of training and experience under the direct supervision of a physician. The fact that such programs are no longer offered does not mean that those individuals who completed such programs are no longer qualified to

perform portable x-ray services, and thus excluded from performing their job duties. Excluding those individuals would not benefit patient health and safety or patient access to portable x-ray services; and may, in fact, reduce the number of qualified portable x-ray technicians and negatively impact access to care.

Comment:

All of the comments received regarding our proposal to revise the requirements for portable x-ray orders supported the proposed revision. One commenter specifically supported, while another specifically disagreed with, the proposal to retain the requirement that each order must specify the reason that portable x-ray services are necessary.

Response:

We agree with the comments that it is necessary and appropriate to revise the requirements for portable x-ray orders to align with the separate payment requirements for diagnostic imaging orders that also apply to portable x-ray services at § 410.32, and are finalizing this change. We believe that it is appropriate to require documentation regarding why this unique service is necessary in place of the more traditional facility-based x-ray service, and are continuing this longstanding element as part of the revised requirements for portable x-ray orders.

Comment:

We received several comments related to Medicare payment policies and Medicare payment manuals related to portable x-ray services. We also received a comment related to the 2018 Crosswalk for Medicare Provider/Supplier to Healthcare Provider Taxonomy, and the Medicare provider and supplier enrollment process.

Response:

These comments are outside of the scope of this rule, and have been shared with the CMS components that are responsible for these subject matter areas.

Final Rule Action:

We are finalizing the changes to §§ 486.104(a) and 486.106(a)(2).

Contact:

Sonia Swancy, 410-786-8445.

11. Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)

a. Provision of Services (§ 491.9(b)(4))

We proposed to change the requirement at § 491.9(b)(4), related to reviewing patient care policies, from an “annual” review to a “biennial” review.

b. Program Evaluation (§ 491.11(a))

We proposed to revise the current requirement at § 491.11(a) by changing the frequency of the RHC or FQHC evaluation from annually to every other year.

We received 30 timely public comments on our proposed changes to the RHC and FQHC requirements. Commenters included industry associations, healthcare systems, individual RHCs and FQHCs and clinicians. Overall, the majority of commenters were supportive of the goal of the proposed changes. Summaries of the major issues and our responses are set forth below.

Comment:

Overall, the majority of comments submitted regarding this topic expressed support for both of the proposed changes to require biennial provision of services policy reviews and clinic or center total program evaluation. Some of the commenters were completely supportive of the proposed biennial change, while some of the commenters stated they were unsure whether it will provide meaningful burden reduction. Other commenters were appreciative of the CMS goal to reduce burden on the RHC or FQHC and stated that the flexibility and opportunity to allow the clinic or center to decide how to most appropriately use their staff time and resources is critical to maintaining the highest standard of care for their patients. One commenter suggested that, in addition to revising the time frame for review, CMS should also reduce the burden of this regulation by removing the requirement that someone in the group of professional personnel that reviews the policies must be from outside the clinic or center's staff.

Response:

We continue to believe these two changes are appropriate, and are finalizing them as proposed.

We agree that the requirement to have someone in the group of professional personnel that reviews the policies be from outside of the clinic or center's own staff can be difficult to meet in medically underserved areas or those where there are health professional shortages. Administrative burden would be decreased by the time often spent trying to find a qualified professio

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