# Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A2018-19599

## Record

- **Collection:** Federal Register
- **Document type:** Proposed Rule
- **Published:** September 20, 2018
- **Citation:** 83 FR 47686

## Text

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-P]
RIN 0938-AT23
Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction

AGENCY:

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

ACTION:

Proposed rule.

SUMMARY:

This proposed rule would reform Medicare regulations that are identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. This proposed rule would increase 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.

DATES:

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on November 19, 2018.

ADDRESSES:

In commenting, please refer to file code CMS-3346-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):

1.
Electronically.
You may submit electronic comments on this regulation to
http://www.regulations.gov.
Follow the “Submit a comment” instructions.

2.
By regular mail.
You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3346-P, P.O. Box 8010, Baltimore, MD 21244-1810.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3.
By express or overnight mail.
You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3346-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

For information on viewing public comments, see the beginning of the
SUPPLEMENTARY INFORMATION
section.

FOR FURTHER INFORMATION CONTACT:

Alpha-Banu Wilson, (410) 786-8687. We have also included a subject matter expert under the “Provisions of the Proposed Rule” section for each provision set out in the proposed rule.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments:
All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received:
http://www.regulations.gov.
Follow the search instructions on that website to view public comments.

Table of Contents

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

I. Executive Summary and Background

A. Purpose

B. Summary of Major Provisions

C. Summary of Costs and Benefits

II. Provisions of the Proposed Regulations

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

B. Ambulatory Surgical Centers

C. Hospice

D. Hospitals

E. Transplant Centers

F. Home Health Agencies

G. Comprehensive Outpatient Rehabilitation Facility (CORF)—Utilization Review Plan (§ 485.66)

H. Critical Access Hospitals

I. Community Mental Health Center (§ 485.914(d))

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

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

L. Emergency Preparedness for Providers and Suppliers

III. Collection of Information Requirements

IV. Response to Comments

V. Regulatory Impact Analysis

A. Statement of Need

B. Overall Impact

C. Sources of Data Used in Estimates of Burden Hours and Cost Estimates

D. Anticipated Effects

E. Alternatives Considered

F. Uncertainty

G. Accounting Statement and Table

H. Reducing Regulation and Controlling Regulatory Costs

I. Conclusion

I. Executive Summary and Background

A. Purpose

Over the past several years, we have revised the Conditions of Participation (CoPs) and Conditions for Coverage (CfCs) to reduce the regulatory burden on providers and suppliers while preserving 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 patient 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 proposed 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 propose changes to the current requirements, CoPs, and Conditions for Coverage (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 proposed 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. Ultimately, these proposals balance patient safety and quality, while also providing broad regulatory relief for providers and suppliers.

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 are soliciting public comments on additional regulatory reforms for burden reduction in future rulemaking. Specifically, we are seeking public comment on additional proposals or modifications to the proposals set forth in this rule 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. Consistent with our “Patients Over Paperwork” Initiative, we are particularly interested in any suggestions to improve existing requirements, within our statutory authority, where they make providing quality care difficult or less effective. We also note 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. We refer readers to the public comments that were submitted in response to the RFI for the following 2017 payment regulations:

• End-Stage Renal Disease Prospective Payment System and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive Program found at
https://www.regulations.gov/docket?D=CMS-2017-0084.

• CY 2018 Home Health Prospective Payment System Rate Update; Value-Based Purchasing Model; and Quality Reporting Requirements found at
https://www.regulations.gov/docket?D=CMS-2017-0100.

• FY 2018 Hospice Wage Index and Payment Rate Update and Hospice Quality found at
https://www.regulations.gov/document?D=CMS-2017-0062-0001.

• FY 2018 Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System RFI, found at
https://www.regulations.gov/docket?D=CMS-2017-0055.

• CY 2018 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates found at
https://www.regulations.gov/docket?D=CMS-2017-0091.

• FY 2018 Inpatient Rehabilitation Facility Prospective Payment System found at
https://www.regulations.gov/document?D=CMS-2017-0059-0002.

• FY 2018 Inpatient Psychiatric Facilities Prospective Payment System found at
https://www.regulations.gov/document?D=CMS-2018-0053-0002.

• CY 2018 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B found at
https://www.regulations.gov/docket?D=CMS-2017-0092.

• FY 2018 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities found at
https://www.regulations.gov/document?D=CMS-2017-0060-0002.

Public comments on the RFIs can be found by searching for the terms “RFI” or “request for information” in the aforementioned 2017 payment regulation dockets on
www.regulations.gov.

The most useful comments will be those that include data or evidence to support the position, offer suggestions to amend specific sections of the existing regulations, or offer particular additions.

B. Summary of Major Provisions

We propose to reduce regulatory burden on providers and suppliers by modifying, removing, or streamlining current regulations that we now believe are excessively burdensome. The proposals fall under three categories: (1) Proposals that simplify and streamline processes, (2) proposals that reduce the frequency of activities and revise timelines, and (3) proposals that are obsolete, duplicative, or that contain unnecessary requirements, as follows.

1. Proposals That Simplify and Streamline Processes

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

We have concluded that a more condensed and flexible process for discharge planning for RNHCIs would reduce burden and simplify the discharge process for patients. Specifically, we propose to revise the requirements at 42 CFR 403.736(a), requiring an evaluation, and § 403.736(b), requiring a discharge plan. Instead of specifying detailed discharge processes, we would simply require RNHCIs to assess the need for a discharge plan for any patient identified as likely to suffer adverse consequences if there is no 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 propose to remove the requirements at 42 CFR 416.41(b)(3), “Standard: Hospitalization.” This would address the competition barriers that currently exist in some situations where hospitals providing outpatient surgical services refuse to sign written transfer agreements or grant admitting privileges to physicians performing surgery in an ambulatory surgical center (ASC). The Emergency Medical Treatment and Labor Act emergency response regulations would continue to address emergency transfer of a patient from an ASC to a nearby hospital.

c. ASC Requirements for Comprehensive Medical History and Physical Assessment

We propose to remove the current requirements at § 416.52(a) and replace 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 would require the operating physician to document any pre-existing medical conditions and appropriate test results, in the medical record, which would have to be considered 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 have concluded that the requirements at 42 CFR 418.106(a)(1), related to having on the hospice staff, an individual with specialty knowledge of hospice medications, is no longer necessary for various reasons. Therefore, we propose to remove these requirements.

In addition, we propose to replace the requirement that hospices provide a copy of medication policies and procedures to patients, families and caregivers with a requirement that hospices provide information regarding the use, storage, and disposal of controlled drugs to the patient or patient representative, and family. This information would be provided in a more user-friendly manner, as determined by each hospice. We believe this could improve patients' and caregivers' comprehension and maximize the effectiveness of the education effort.

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

We propose to move the requirements at § 418.112(f) to the “Written agreement” standard at new § 418.112(c)(10). Moving the requirement for facility staff orientation from a standalone requirement that places responsibility solely on hospices to the section of the rule related to the written agreement established between hospices and skilled nursing facilities (SNFs) and intermediate care facilities for individuals with intellectual disabilities (ICFs/IID) will allow both entities to negotiate the terms for assuring orientation of facility staff. This will give hospices more freedom to develop innovative approaches and avoid effort duplication with other hospices that are orienting the same facility staff.

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

We propose a new standard at 42 CFR 482.21(f), “Unified and integrated QAPI program for multi-hospital systems.” We would allow a hospital that was part of a hospital system consisting of multiple separately certified hospitals using a system governing body that was legally responsible for the conduct of two or more hospitals, the system governing body could elect to have a unified and integrated Quality Assessment and Performance Improvement (QAPI) 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 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 would have to demonstrate that: The unified and integrated QAPI program was 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 the unified and integrated QAPI program would establish and implement policies and procedures to ensure that the needs and concerns of each of its separately certified hospitals, regardless of practice or location, were given due consideration, and that the unified and integrated QAPI program would have mechanisms in place to ensure that issues localized to particular hospitals were duly considered and addressed.

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

We propose to allow hospitals the flexibility to establish a medical staff policy describing the circumstances under which such hospitals could utilize a pre-surgery/pre-procedure assessment for an outpatient, instead of a comprehensive medical history and physical examination (H&P). We believe that the burden on the hospital, the practitioner, and the patient could be greatly reduced by allowing this option. In order to exercise this option, a hospital would need to document the assessment in a patient's medical record. The hospital's policy would have to 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 propose 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 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 infection control 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 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

We propose at § 482.61(d) to clarify the scope of authority for non-physician practitioners or Doctor of Medicine Doctor 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 proposing a nomenclature change at part 482 and the transplant center regulations at §§ 482.68, 482.70, 482.72 through 482.104, and at § 488.61. This change would update 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 propose to remove the requirements at § 482.82 that require transplant centers to submit clinical experience, outcomes, and other data 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 propose to remove the requirements at § 488.61(f) through (h) with respect to the re-approval process for transplant centers. This change corresponds to the proposed removal of the provisions § 482.82.

m. HHA Requirements for Verbal Notification of Patient Rights and Responsibilities

We propose to remove the requirements for verbal (meaning spoken) notification of patient rights to those patient rights elements for which the Social Security Act (the Act) requires such verbal notification. Specifically, we propose to only require verbal notice for those rights related to payments made by Medicare, Medicaid, and other federally funded programs, and potential patient financial liabilities.

n. Personnel Requirements for Portable X-Ray Technologists

We propose to revise § 486.104, “Condition for coverage: Qualifications, orientation and health of technical personnel”, to align the current requirements at § 486.104(a)(1), (2), (3), (4) with § 482.26(c)(2), which refers to qualifications of radiologic technologists in hospitals and is focused on the qualifications of the individual performing services.

o. Portable X-Ray Requirements for Orders

We propose to revise the requirements for portable x-ray orders at § 486.106(a)(2). We propose to remove the requirement that physician or non-physician practitioner's orders for portable x-ray services must be written and signed. We also propose to replace 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. These proposed changes would simplify the ordering process for portable x-rays and promote the use of more efficient ordering methods, such as electronic orders.

p. Emergency Preparedness Requirements: Requirements for Emergency Plans

We propose to eliminate part of the requirement from § 482.15(a)(4) for hospitals and other parallel provisions for other affected Medicare and Medicaid providers and suppliers (referred to collectively as “facilities,” throughout the remainder of this proposed rule where applicable), 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. In accordance with the remaining requirement at § 482.15(a)(4), facilities would still be required to include a process for cooperation and collaboration with local, tribal, regional, State and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. Only the documentation requirements would be eliminated.

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

a. Home Health Agency (HHA) Requirements for Providing Patients With Copies of Clinical Records

We propose to remove the requirement that Home Health Agencies (HHAs) provide a copy of the clinical record to a patient, upon request, by the next home visit. We propose to retain the requirement that the copy of the clinical record must be provided, upon request, within 4 business days.

b. CAH Annual Review of Policies and Procedures

We propose to change the requirement at § 485.635(a)(4) to reflect the current medical practice where providers are expected to update their policies and procedures as needed in response to regulatory changes, changes in the standard of care, or nationally recognized guidelines. The current CoP at § 485.635(a)(4) requires a CAH's professional personnel to review its policies at least annually and the CAH to review as necessary. We propose to reduce burden and provide flexibility by requiring the CAH's, professional personnel, at a minimum, to conduct a biennial review of its policies and procedures instead of an annual review.

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

We propose to amend 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.

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

We propose to remove the requirement that all Community Mental Health Center (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 propose to retain the 30 day assessment update time frame in accordance with existing Medicare payment requirements for partial hospitalization services.

e. RHC and FQHC Review of Patient Care Policies

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

f. RHC and FQHC Program Evaluation

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

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

On September 16, 2016, we finalized a rule imposing emergency preparedness requirements on most Medicare and Medicaid facilities (Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 81 FR 63860). Facilities participating in Medicare and/or Medicaid are now required, among other things, to review their emergency preparedness programs annually. This includes a review of their emergency plans, policies and procedures, communication plans, and training and testing programs. We propose to revise these requirements, so that applicable providers and suppliers have increased flexibility with compliance.

h. Emergency Preparedness Requirements: Requirements for Training

As with the review of the emergency plan previously discussed, we propose to revise the requirement that facilities develop and maintain a training program based on the facility's emergency plan annually. Instead, we would require that facilities provide training biennially (every 2 years) after facilities conduct initial training for their emergency program. In addition, we propose to require additional training when the emergency plan is significantly updated.

i. Emergency Preparedness Requirements: Requirements for Testing

For inpatient providers, we propose to expand the types of acceptable testing exercises that may be conducted such that one of the two annually required testing exercises may be an exercise of their choice, which may include one community-based full-scale exercise, if available, an individual facility-based functional exercise, a drill, or a tabletop exercise or workshop that includes a group discussion led by a facilitator. For outpatient providers, we propose to revise 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 chose the testing exercise of their choice which may include a community-based full-scale exercise, if available, a facility-based functional exercise, a drill, or a tabletop exercise or workshop that includes a group discussion led by a facilitator.

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

a. Hospice Aide Training and Competency Requirements

We propose to revise § 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. We would defer to State licensure requirements regardless of their content or format, and would allow states to set forth training and competency requirements that meet the needs of their populations. We believe that this change would streamline the hiring process for most hospices.

b. Medical Staff: Autopsies

We propose 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 propose to instead defer to State law regarding such medical-legal requirements.

c. Hospital and CAH Swing-Bed Requirements

We propose to remove 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 cross-reference gives a resident the right to choose to, or refuse to, perform services for the facility if they so choose. If the resident works, the facility must document it in the resident's plan of care, noting whether the services are voluntary or paid, and, if paid, providing wages for the work being performed, at prevailing rates.

We propose to remove 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). This cross reference requires 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 propose to remove 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 propose to remove 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 Supervision Requirements

We propose to revise the requirement at § 418.76(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 propose to remove § 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). The provider agreement rules note that the basis for termination of the provider agreement includes failure of the provider to furnish ownership information as required in § 420.206, making this CAH CoP requirement duplicative of those regulations.

C. Summary of Costs and Benefits

1. Overall Impact

This proposed rule would create savings and reduce burden in many areas. Several of the proposed changes would create measurable monetary savings for providers and suppliers, while others would create less quantifiable savings of time and administrative burden. We estimate a total annual savings of $1,123 million using the midpoints of estimated ranges. We also estimate a one-time implementation cost of $64 million.

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 proposed rule):

Table 1—Summary of Costs and Benefits

Provider or supplier type and description of proposed provisions
Frequency

Number of
affected
entities

Estimated
annual
savings
or benefits
($millions)

Religious Nonmedical Health Care Institution:

• Discharge Planning
As patients are discharged (Estimated 619 annual discharges)
18
(*)

Ambulatory Surgical Center:

• Governing Body and Management
Upon failed hospital transfer agreement attempts
5,557
(*)

• Patient Admission, Assessment and Discharge (History and Physical) **
Every patient admission to an ASC or hospital outpatient

1
5,557

2
5,031

454

• Medical Records
Recurring annually
5,557
0

Hospices:

• Drugs and Biologicals, Medical Supplies, and Durable Medical Equipment
Recurring annually
1,151
80

• Hospices That Provide Hospice Care to residents of a SNF/NF or ICF/IID
Recurring annually
4,602
(*)

• Hospice Aide and Homemaker Services
Recurring annually
3,498
2

Hospitals:

• Quality Assessment and Performance Improvement Program
Recurring annually
5,031
28

• Medical staff: Autopsies
Recurring annually
5,031
0

• Infection Control
Recurring annually
5,031
105

• Special requirements for hospital providers of long-term care services (“swing-beds”)
Recurring annually
5,031
30

• Special Requirements for Psychiatric Hospitals
Recurring annually
574
62

Transplant Programs:

• Various provisions related to performance ***
Recurring annually
750

(
3
)

Home Health Agencies:

• Patient rights
Recurring annually
12,624
55

• Home health aide services
Recurring annually
12,624
0

• Clinical records
Recurring annually
12,624
0

Critical Access Hospitals:

• Provision of Services
Recurring biennially
1,343
2

• Organizational structure
Recurring annually
1,343
(*)

• Special requirements for hospital providers of long-term care services (“swing-beds”)
Recurring annually
1,246
86

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 ***
Annual
500
31

• Removing written orders
Annual
500
29

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

• Provision of Services
Recurring biennially
12,034
7

• Program Evaluation
Recurring biennially
12,034
9

Emergency Preparedness for Providers and Suppliers:

• Annual Review of Emergency Preparedness Program
Recurring annually
72,844
94

• Emergency Plan
Recurring annually
68,254
7

• Training and Testing-Training Program
Recurring annually
69,196
33

• Training and Testing-Testing
Recurring annually
36,971
9

Total Annual Savings

1,123

Life-extending benefits for transplant patients **

(
3
)

* Amount is less than 1 million dollars.
** These include proposed 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.

1
(ACSs).

2
(Hospitals).

3
Not Quantified.

II. Provisions of the Proposed Regulations

A. 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. We have implemented these provisions in 42 CFR part 403, subpart G, “Religious Nonmedical Health Care Institutions Benefits, Conditions of Participation, and Payment.” Currently there are 18 Medicare-certified RNHCIs that are subject to the RNHCI regulations.

A RNHCI provides only non-medical items and services through non-medical nursing personnel on a 24-hour basis. These services are provided to beneficiaries who choose to rely solely upon a religious method of healing and for whom the acceptance of medical services would be inconsistent with their religious beliefs. “Religious non-medical care” or “religious method of healing” means care provided under established religious tenets that prohibit conventional or unconventional medical care for the treatment of the patient, and exclusive reliance on religious activity to fulfill a patient's total healthcare needs. The RNHCI does not furnish medical screening, examination, diagnosis, prognosis, treatment, or the administration of drugs or biologicals to its patients.

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. We reviewed the current CoPs and payment for RNHCIs at 42 CFR part 403, subpart G, in an effort to reduce burden and provide flexibility as feasible. As a result of the review, we identified discharge planning as one area where we could reduce burden. The current discharge planning requirements at § 403.736(a) and (b) require RNHCIs to have a discharge planning process that applies to all patients, and to assure that appropriate post-institution services are obtained for each patient, as necessary.

Currently, § 403.736(a)(1) requires RNHCIs to assess the need for a discharge plan for any patient identified as likely to suffer adverse consequences if there is no planning and for any other patient upon his or her request or at the request of his or her legal representative. In accordance with § 403.736, this discharge planning evaluation must be initiated at admission and must include the following:

• An assessment of the possibility of a patient needing post-RNHCI services and of the availability of those services.

• An assessment of the probability of a patient's capacity for self-care or of the possibility of the patient being cared for in the environment from which he or she entered the RNHCI.

• The staff must complete the assessment on a timely basis so that arrangements for post-RNHCI care are made before discharge and so that unnecessary delays in discharge are avoided.

• The discharge planning evaluation must be included in the patient's care record for use in establishing an appropriate discharge plan. Staff must discuss the results of the discharge planning evaluation with the patient or a legal representative acting on his or her behalf.

• If the discharge planning evaluation indicates a need for a discharge plan, qualified and experienced personnel must develop or supervise the development of the plan.

• In the absence of a finding by the RNHCI that the beneficiary needs a discharge plan, the beneficiary or his or her legal representative may request a discharge plan. In this case, the RNHCI must develop a discharge plan for the beneficiary.

• The RNHCI must arrange for the initial implementation of the beneficiary's discharge plan.

• If there are factors that may affect continuing care needs or the appropriateness of the discharge plan, the RNHCI must reevaluate the beneficiary's discharge plan. The RNHCI must inform the beneficiary or legal representative about the beneficiary's post-RNHCI care requirements.

• The discharge plan must inform the beneficiary or his or her legal representative about the freedom to choose among providers of care when a variety of providers is available that are willing to respect the discharge preferences of the beneficiary or legal representative.

Since the RNHCI's religious tenets prohibit conventional or unconventional medical treatment of a beneficiary, we believe that the extensive requirements previously discussed are unnecessarily burdensome, because medical post-institution services are not utilized by RNHCI patients.

Based on our experience with RNHCIs, patients are routinely discharged to home and not to an acute or post-acute care medical provider or supplier. We do not see a need for RNHCIs to develop a discharge plan that includes medical care once a patient leaves the RNHCI, because doing so is not in keeping with the religious tenets and goals of the facility. However, we believe that it is important to discuss with the caregiver at home about a safe and healing environment at home and to monitor the individual to access any changes in the patient's well-being and the need to seek additional care. We would expect RNHCIs to have policies and procedures that address their discharge processes. If the RNHCI determines that a patient either does or does not require discharge instructions, this decision must be made based on the RNHCI's existing policies. Surveyors would be expected to review the RNHCI policies and confirm that either the existence or lack of discharge instructions is consistent with policies established by the RNHCI.

We propose a more condensed and flexible process for discharge planning and instructions for RNHCIs. Specifically, we propose to remove the requirements at § 403.736(a) and (b), proposing instead to require RNHCIs to provide discharge instructions to the patient and/or the patient's caregiver when the patient is discharged home. We also propose that paragraphs (c) and (d) be redesignated as paragraphs (b) and (c).

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 are soliciting public comments on additional regulatory reforms for burden reduction for future rulemaking. Specifically, we are seeking public comment on additional proposals or modifications to the proposals set forth in this rule that would further reduce burden on RNHCIs and create cost savings, while also preserving quality of care and patient health and safety. Consistent with our “Patients Over Paperwork” Initiative, we are particularly interested in any suggestions to improve existing requirements, within our statutory authority, where they make providing quality care difficult or less effective.

We also note that such suggestions could include or expand upon comments submitted in response to the FY 2018 Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System RFI, found at
https://www.regulations.gov/docket?D=CMS-2017-0055.
Public comments on the RFI can be found by searching for the terms “RFI” or “request for information” in the aforementioned 2017 payment

regulation docket on
www.regulations.gov.

The most useful comments will be those that include data or evidence to support the position, offer suggestions to amend specific sections of the existing regulations, or offer particular additions.

Contact:
Mary Collins, (410) 786-3189.

B. Ambulatory Surgical Centers

Section 416.2 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. Currently, there are 5,591 Medicare certified ASCs in the United States.

Section 1832(a)(2)(F)(i) of the Act specifies that ASCs must meet health, safety, and other requirements specified by the Secretary in regulation in order to participate in Medicare. The Secretary of the Department of Health and Human Services (the Secretary) is responsible for ensuring that the CfCs protect the health and safety of all individuals treated by ASCs, whether they are Medicare beneficiaries or other patients.

The ASC regulations were first published on August 5, 1982 (47 FR 34082) and have since been amended several times. On November 18, 2008, we published a final rule, entitled “Medicare Program: Changes to the Ambulatory Surgical Center Conditions for Coverage”, (73 FR 68502) revising four existing health and safety CfCs and created three new health and safety CfCs. In addition, several other small changes have been made in the past several years to amend the emergency equipment requirements (77 FR 29002) and radiologic services requirements required in the ASCs (79 FR 27106).

1. Governing Body and Management (§ 416.41(b)(3)(i) and (ii))

Hospitalization Requirements

Section 416.41(b) outlines the patient hospitalization procedures that ASCs must have in place to participate in Medicare. Section 416.41(b)(1) states the ASC must have an effective procedure for the immediate transfer, to a hospital, of patients requiring emergency medical care that surpass the capabilities of the ASC. Additionally, there are two requirements that also pertain to ASC patient hospital transfers. Section 416.41(b)(3)(i) and (ii) requires ASCs to have a written transfer agreement with a hospital that meets certain Medicare requirements or ensure all physicians performing surgery in the ASC have admitting privileges in a hospital that meets certain Medicare requirements. A written transfer agreement and physician admitting privileges is intended to make sure there is a relationship between the ASC and local hospital that would serve the patient in the event of a medical emergency. Over the past 5 years, we have heard from the largest ASC trade association and multiple ASCs that we need to address the widespread issue of the growing number of hospitals that are declining to work with ASCs (either by declining to sign a transfer agreement or by declining to allow admitting privileges to the hospital by physicians who work in ASCs) due to competition between hospital outpatient surgery departments and ASCs. CMS has continually worked with the ASCs and hospitals directly to resolve this requirement issue, however, several facilities have not been able to reach a positive outcome. Furthermore, we have seen no evidence of negative patient outcomes due to a lack of such transfer agreements and admitting privileges. Research reports published by the ASC Quality Collaborative indicate the national hospital transfer rate from an ASC to a hospital for care is about 1.25 per 1,000 ASC admissions (
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ASC-Quality-Reporting/index.html
). ASCs are already required to have personnel trained and available for emergency response when there is a patient in the ASC. In addition, the ASC is expected to provide initial stabilizing treatment until the patient is transferred. Finally, the current requirement dates back to 1982, when ASCs were a newly emerging medical care option and there was reasonable concern as to needed emergency care being available.

EMTALA was enacted in 1986 and as its enforcement evolved over time this effectively has rendered such transfer agreements unnecessary, since EMTALA imposed requirements on all hospitals to provide emergency care without regard to prior arrangements until a patient could be stabilized and, as appropriate, either discharged because further care was not necessary, or transferred to another facility or care arrangement. Therefore, we conclude that these requirements are creating an administrative barrier to efficient ASC operations without any improvement in patient care or safety. In the absence of a transfer agreement or admitting privileges, ASCs would continue to have access to local emergency services to transfer patients to the nearest appropriate hospital for continued care. Hospitals are required to provide appropriate screening and stabilizing treatment for patients experiencing emergency medical conditions in accordance with the regulations set forth at § 489.24.

In light of these factors, we propose to remove the requirement for a written hospital transfer agreement or hospital physician admitting privileges at § 416.41(b)(3). We believe the proposed changes to the ASC hospitalization standard requirements would streamline ASC administrative operations and still assure the safety of these services while being less burdensome for Medicare-certified ASC facilities. 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 effective procedure, ASCs are not precluded from obtaining a hospital transfer agreements or hospital physician admitting privileges when possible. We would also like to solicit comments on burden that may result from the absence of a transfer agreement between ASCs and hospitals.

2. 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 completed not more than 30 days before the date of the scheduled surgery. We have received feedback from stakeholders that the current requirement is overly burdensome for a large majority of healthy patients, specifically those patients who are receiving minimally invasive surgical procedures that are performed under minimal sedation or local anesthesia alone. For example, cataract surgery is the most commonly performed ASC surgical procedure among Medicare beneficiaries. Modern cataract surgery is a short procedure using mild sedation and local anesthesia. Medical complications for cataract surgery before, during and after surgery are extremely rare. Other ophthalmic procedures, such as Yttrium-Aluminum Garnet (YAG) laser capsulotomy, does not require a local

anesthetic and is a painless 60 second procedure that can be completed during a routine patient visit. However, when it is performed in an ASC, which enables one laser to be utilized by multiple surgeons for procedures, the requirement for a history and physical is burdensome to the patient and medical staff without any additional benefits. One study published in the New England Journal of Medicine concluded that routine preoperative medical testing (blood counts, clotting studies, chemistry panels, electrocardiograms, chest x-ray, etc.) conferred no measurable value in reducing adverse medical events on the day of surgery or up to one week postoperatively (Schein OD, Katz J, Bass EB, et al. Study of Medical Testing for Cataract Surgery. The value of routine preoperative medical testing before cataract surgery. New England Journal of Medicine. 2000; 342(3): 168-75). Another article on this issue from the Cochrane Database of Systematic Reviews reviewed three randomized clinical trials and also found that routine preoperative testing did not increase the safety of cataract surgery (Keay L, Lindsley K, Tielsch J, Katz J, and Schein O. Routine preoperative medical testing for cataract surgery, 2012;3:CD007293). These results are consistently found for other ambulatory surgeries. For example, one study tested over one thousand patients over a wide range of surgeries and found no increase in adverse events as a result of no preoperative testing (Chung F, Yuan H, Yin L, Vairavanathan S, and Wong DT. Elimination of preoperative testing in ambulatory surgery. Anaesth Analg. 2009 Feb: 108(s):467-75). Another and much larger study reviewed the literature on a broad range of ambulatory surgeries and examined records of results for over 73,000 patients who underwent various hernia surgeries and found that preoperative testing was not associated with rates of postoperative complications.

The vast majority of outpatient surgeries are performed on an outpatient or “ambulatory” basis precisely because they involve extremely low risk of complications due either to preexisting conditions or to the risk of the surgical procedure itself. Most such procedures are among those that are also routinely performed in physician offices. We further note that the specification of any short time period for the acceptability of pre-surgical evaluations (in other words, within 30 days) is inherently arbitrary and burdensome for the ASC patient population. For example, in the case of a cataract patient who needs a procedure in both eyes, a 31-day delay between the two operations would trigger the need for another physical examination and, possibly, another set of laboratory tests. Likewise, if an unanticipated event such as a death in the family required delaying a procedure by more than the 30th day after the examination, a duplicative examination and any necessary tests would be required. Moreover, if the examination and tests had been performed timely, but the results not transmitted in time, the duplicative examination and tests would be required.

We propose to remove the current requirements at § 416.52(a) and replace them with requirements that defer to the facility's established policies for pre-surgical medical histories and physical examinations (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 propose to require each ASC to establish and implement a policy that identifies patients who require an H&P prior to surgery. We propose that the policy would include the time frame for the H&P to be completed prior to surgery. ASCs may choose to continue the 30 day policy that has existed in regulation since 2008, or may choose a different time frame based on available evidence and standards of practice. We propose 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 propose 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.

Particular subgroups of patients may benefit from more extensive and complete medical history and physical assessments prior to surgery. Those subgroups, for example, might include patients who cannot lie supine, have chest pain or shortness of breath, have pacemakers, have had a recent heart attack, on dialysis, or take insulin (Schein OD, Pronovost PJ. A Preoperative Medical History and Physical Should Not Be a Requirement for All Cataract Patients. DOI: 10.1007/s11606-017-4043-9, March 20, 2017.)

We would retain the requirement that the physician performing the surgery or other qualified practitioner perform a pre-surgical assessment for each ASC patient, including documentation regarding any allergies to drugs and biologicals. We would also retain the requirement that any documentation related to the H&P that may have been performed would be placed in the patient's medical record prior to the surgical procedure.

Our proposed change would simply eliminate the requirement for a pre-operative H&P, while allowing patient-specific physician decisions and ASC-wide policy decisions to determine what examinations and tests are necessary for each patient. Such decisions could be informed by specialty societies, medical literature, past experience, or other factors. We believe the proposed changes will reduce burden and provide flexibility for patients while maintaining a balance of health and safety requirements for providers.

In reading the discussion that follows, it is important to understand that the requirement for making a patient assessment at the ASC, on the day of surgery and before surgery commences, remains unchanged. This assessment addresses any new surgical risks for the patient with procedure-specific or patient-specific questions (for example, has the patient had a fever in the last 24 hours or, for a patient with diabetes, have there been any recent changes to random blood glucose levels with at-home monitoring?). The questions focus on any recent changes or updates to the patient's condition since the last H&P that might adversely impact the outcome of the procedure for the patient. This assessment must occur before proceeding with the procedure. Furthermore, we are not proposing to eliminate or discourage comprehensive pre-surgical H&Ps where warranted. To replace the current arbitrary 30-day rule applying to all patients, regardless of procedure or risk, we propose that each facility make an independent determination as to which procedures and which patient profiles would dictate requiring a pre-operative history and examination, taken before (but not necessarily 30 days before and possibly many months before) the day of surgery.

We request comment on whether we should make exceptions, such as for particular patient conditions or surgical procedures, that should not be entitled to such broad discretion, and for any evidence that would support such exceptions. We would also be interested in knowing if particular examinations or tests should be normal for those

conditions or procedures, and whether such standards would need be imposed by regulation or could rely on physician and facility judgment and practices.

3. Medical Records (§ 416.47)

The current regulations at § 416.47 require ASCs to maintain complete, comprehensive, and accurate medical records to ensure adequate patient care. Section 416.47(b) sets out the form and content of the record, including specific items that must be included in the medical record. To conform to the proposed changes to the medical history and physical examination requirements at § 416.52(a), we propose to revise the requirement at § 416.47(b)(2) that states “Significant medical history and results of physical examination”, by adding “as applicable.” This proposed revision would reflect the fact that, in accordance with our proposed changes to § 416.52(a), not all ASC patients may have a medical history and physical examination report that would be included in the medical record.

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 are soliciting public comments on additional regulatory reforms for burden reduction in future rulemaking. Specifically, we are seeking public comment on additional proposals or modifications to the proposals set forth in this rule that would further reduce burden on ASCs and create cost savings, while also preserving quality of care and patient health and safety. Consistent with our “Patients Over Paperwork” Initiative, we are particularly interested in any suggestions to improve existing requirements, within our statutory authority, where they make providing quality care difficult or less effective. We also note that such suggestions could include or expand upon comments submitted in response to the RFI that was included in the CY 2018 OPPS/ASC proposed rule. Public comments in response to this RFI can be found at the following link:
https://www.regulations.gov/docket?D=CMS-2017-0091.
Public comments on the RFI can be found by searching for the terms “RFI” or “request for information” in the aforementioned 2017 payment regulation docket on
www.regulations.gov.

The most useful comments will be those that include data or evidence to support the position, offer suggestions to amend specific sections of the existing regulations, or offer particular additions.

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

C. Hospice

1. Hospice Aide and Homemaker Services (§ 418.76)

Under the current hospice CoP requirements at § 418.76, all hospice aides are required to meet specific, federally-established, training and education requirements. The requirements are based on the training and education requirements for home health aides as set forth at section 1891(a)(3)(D) and 1861(m)(4) of the Act. Specifically, the current CoPs (§ 418.76(a)) require that a hospice aide must be a person who has completed one of the following: A training program and competency evaluation as specified in the regulations; a competency evaluation program that meets the requirements specified in the regulation; a nurse aide training and competency evaluation program in accordance with the requirements set forth in the long term care requirements; or a State licensure program that meets the requirements at § 418.76(b) (training) and (c) (competency evaluation). At § 418.76(b) and (c) of the hospice CoPs, we specifically detail the content and format of aide education, training, and of competency evaluations, including the number of classroom and practical training hours that must be completed, the skills that must be addressed, and the general method (exam or practical observation) used for assessing competency in those various skills.

We initially proposed and finalized these requirements in order to be consistent with the requirements that apply to home health aides (§ 484.80). Historically, a significant number of hospice agencies were HHA-based, meaning that the same entity provides both hospice and home health care services, often utilizing the same pool of staff to furnish both services. Using similar requirements for both hospices and home health agencies streamlines operations for hospices that are home health agency based. Due to the evolution of the hospice industry as a whole, the proportion of HHA-based hospices has significantly declined, reducing the streamlining benefits that occur by having the same requirements for aides in both hospice and home health settings.

As the streamlining benefits for the hospice industry as a whole have reduced, the burden/benefit ratio related to meeting the prescriptive home health aide qualification requirements, which are required to be set forth in regulation by section 1891(a) of the Act, has shifted. While section 1891(a) of the Act requires CMS to establish prescriptive requirements for aides who provide services on behalf of home health agencies, the Act does not establish similarly prescriptive requirements for aides who provide services on behalf of hospices. In addition to the hospice aide qualifications that are established in the hospice CoPs, hospice aides must also be licensed, certified, or registered by the State in which they are practicing (if available), in accordance with the requirements at § 418.116(a). A hospice industry association conducted an informal survey of all 50 states and found that 76 percent of those states currently have their own hospice aide qualifications for licensure, certification, or registration. Therefore, we assume that in 76 percent of states, hospice aides are required to meet two different qualification standards (one for state licensure, certification, or registration; and one for compliance with the Federal CoPs).

This regulatory approach has created unintentional burden during the hiring process for all of the non HHA-based hospices, as well as those HHA-based hospices that do not share staff with the home health agency portion of their organization. The unintentional burden is the result of hospices having to verify during the aide hiring process that the applicant meets both the state licensure, certification, or registration requirements, and also meets the specific training and competency requirements set forth in the CoPs. State requirements may change at any time and hospices may receive employment applications from aides that have been trained in another setting such as nurse aide training in the long term care environment or private duty aide training not subject to Federal regulations, so hospices are burdened with the need to review, in detail, each employment applicant's training and competency content and format each time they need to make a new hire. For example, State requirements may specify a different number of training hours to be completed, a different format for assessing competency in a specific skill, or even a different set of mandatory skills in accordance with State scope of practice requirements. We believe that this is an unnecessary and inefficient use of hospice staff time that does not serve to improve patient care and safety.

To address these concerns, we propose to revise § 418.76(a)(1)(iv) to remove the requirement that a 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, regardless of their content or format, and would allow states to set forth training and competency requirements that meet the needs of their populations. We do not believe that it is necessary for the Federal government to oversee the qualifications established by states because these states have already demonstrated their willingness and ability to regulate this area along with federally established requirements. This change would also streamline the hiring process for most hospices. We would continue to require 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 would continue to require 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). We believe that these requirements will ensure that aides only perform duties for which they are trained and that they perform such duties in a safe and effective manner. Furthermore, we would continue to require that hospices must comprehensively assess patients on a regular schedule and on an as needed basis (§ 418.54(a), (b) and (d)), 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 (§ 418.56(b) through (d)), assure that the plan of care reflects patient and family goals (§ 418.56(b) and includes all services (including aide services) necessary to manage pain and symptoms (§ 418.56(c)), and ensure that hospice care and services are provided in accordance with the plan of care and are based on all assessments of the patient and family needs (§ 418.56(e)). Furthermore, hospices would continue to be required to provide hospice care that optimizes comfort and dignity, and is consistent with patient and family needs and goals (§ 418.100(a)). Finally, hospices would continue to be required to maintain an effective, ongoing, hospice-wide data-driven quality assessment and performance improvement program that involves all hospice services, including aide services, that focuses on indicators related to improved patient outcomes, and takes actions to demonstrate improvement in hospice performance (§ 418.58). While deferring to state requirements for hospice aide qualifications would likely introduce a new level of variability in the aide hiring process, we believe that the remaining hospice CoPs would continue to assure that hospice aide services meet the needs of patients and families, and are delivered in a safe and effective manner.

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

The June 5, 2008 Hospice CoP final rule (73 FR 32088) 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 (§ 418.106(a)(1)). This requirement was implemented as a direct result of public comments that were submitted in regards to the May 2005 Hospice CoP proposed rule (70 FR 30840). The May 2005 Hospice CoP proposed rule proposed to retain longstanding requirements for pharmacist involvement in the planning and delivery of drugs and biologicals for patients that receive care in the hospice inpatient setting. Commenters suggested that we broaden our proposal and apply it to patients receiving care in all settings. The commenters stated that, since drugs are prescribed to virtually all hospice patients, these patients should benefit from the expertise of a pharmacist and the additional level of drug oversight required by the regulatory standards. We agreed with the commenters that it would be beneficial to patients to broaden the scope of the pharmacy requirements. For this reason, we finalized a requirement at paragraph (a), “Managing drugs and biologicals,” to require that each hospice ensures 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. Hospices have the option of using a licensed pharmacist or an individual who has an extensive and up-to-date knowledge of drugs, to fulfill this role.

At the time when this requirement was finalized in 2008, we estimated that 1,600 hospices (56 percent of all hospices) were already contracting with pharmacy benefit management companies to provide drugs and pharmacist services to each of their patients at a single bundled service rate. These hospices were already realizing the benefits of specialized drug management expertise in the absence of Federal regulations. Since 2008, the use of pharmacy benefit management companies, including their built-in pharmacy experts, has continued to grow at a rapid pace. Although there have been no formal studies on the proliferation of pharmacy benefit management company use in hospice, conversations with industry experts lead us to estimate that, at minimum, 75 percent of existing hospices use such services. Experts estimate that the more likely number is between 90 and 95 percent of hospices due to various factors that hospices find to be desirable, such as predictable capitated medication fees and direct to the patient door medication delivery services. Since the use of pharmacology experts has become routine due to the proliferation of pharmacy benefit management companies that provide pharmacist services for each patient bundled with drug and biologics supply services, we believe that it is no longer necessary to include a regulatory requirement specifically related to the use of a pharmacology expert. As pharmacy benefit management services bundle drug and biologics supply services with expert advice, and since industry experts estimate that at least 75 percent and as many as 95 percent of hospices use pharmacy benefit management services for reasons primarily unrelated to this specific regulatory requirement, we conclude that the vast majority of hospices, and thus the vast majority of hospice patients, will continue to receive such advice and guidance in the absence of regulation. This proposed change would allow hospices to more seamlessly integrate the information provided by the drug management expert into routine interdisciplinary group meetings rather than having to use burdensome formulaic approaches that hospices currently implement in order to demonstrate compliance with the regulation.

In addition to changes in the pharmacy benefit management landscape, there have also been significant changes in the hospice and palliative care nursing and physician landscapes. Since publication of the 2008 Hospice CoP final rule (73 FR 32088), the number of hospice and palliative care nursing and physician specialty training and certification programs has rapidly expanded. As more hospice and palliative care

nursing and physician specialists have entered the job market, more hospices are employing these clinicians with advanced skill sets. In hospices that do not use a pharmacy benefit management service, these clinicians typically fill the role of the required individual with education and training in drug management in addition to being the regular physician or nurse member of the interdisciplinary group. As these clinicians are already members of the core interdisciplinary group in accordance with the requirements at § 418.56(a), we believe that hospices will continue to benefit from their expertise in the absence of Federal regulations. For these reasons, we conclude that the requirements at § 418.106(a)(1) are no longer necessary to assure patient safety and the effectiveness of hospice care. Furthermore, we believe that hospices may achieve a cost savings upon removal of this requirement because they will no longer need to assure a dedicated time in each interdisciplinary group meeting in order to be able to document that a specific conversation occurred among group members, and thus document compliance with the regulation. Therefore, we propose to delete the requirements at § 418.106(a)(1).

Hospices would continue to be required to comprehensively assess patients on a regular schedule and on an as needed basis (§ 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 (§ 418.56(b) through (d)). To the extent that a hospice needs additional expert information or expertise beyond what is provided by hospice employees and the pharmacy expertise of any pharmacy benefit manager that a hospice may choose to use in order to meet a given patient's assessment, care planning, and care delivery medication-related needs, we would continue to require that it secure such information and expertise. 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.

The 2008 Hospice CoP final rule (73 FR 32088) also required hospices, at § 418.106(e)(2)), to: (1) Provide a copy of the hospice written policies and procedures on the management and disposal of controlled drugs to the patient or patient representative and family; (2) discuss the hospice policies and procedures for managing the safe use and disposal of controlled drugs with the patient or representative and the family in a language and manner that they understand to ensure that these parties are educated regarding the safe use and disposal of controlled drugs; and (3) document in the patient's clinical record that the written policies and procedures for managing controlled drugs was provided and discussed. We believe that the hospice, as well as the patient, family, and caregivers share the responsibility and accountability for maintaining controlled substances in the home. We believe that hospices must assume responsibility to educate the patient and family about the proper use and disposal of controlled drugs and biologicals that are maintained in the home environment. The drug policies and procedures also help the hospice explain its own role in controlled drug management.

We believe that this requirement continues to be relevant, particularly in relationship to implementing proper storage and security precautions that can prevent theft and other drug diversion in the home, and proper disposal when a drug is no longer needed to prevent inappropriate access and environmental damage. Therefore, we continue to expect that hospices would have such policies and procedures for their own internal use as part of routine business practice. However, hospice policies and procedures are typically written in ways that are not easily understood by the general public. Hospice clinicians spend more time than expected explaining technical terms and otherwise translating the policies and procedures into layperson's terms. We do not believe that this process of explaining complex documents in a manner that is meaningful to patients and families is beneficial to patients, families, caregivers, or hospices.

We propose to replace the requirement 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 and families. This information would be provided in a more user-friendly manner, as decided by each hospice, which we believe can improve comprehension and maximize the effectiveness of the education effort. Furthermore, by providing information in a more user-friendly manner, hospices would be able to eliminate time spent explaining technical terms and other otherwise translating the policies and procedures into layperson's terms. This would create more efficiency while simultaneously improving hospice-patient communications. Hospices would be free to choose the content and format(s) that best suits their needs and the needs of their patient population. We propose to require that, regardless of the format chosen, this information must be provided to patients and families in a manner that allows for continual access to the information on an as-needed basis in order to assure that patients and families have information available when they need it. CMS is soliciting input concerning what a standardized educational format should entail, including whether the format should be paper or electronic; in writing, pictorial, video, or audio; what general subjects should be addressed in regards to storage, disposal, use, and risks; and what specific content should be included to minimize opioid diversion and maximize safety.

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, 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.

3. 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. This orientation is required to include information concerning the hospice philosophy, including hospice policies and procedures regarding methods of comfort, pain control, symptom management, as well as principles about death and dying, individual responses to death, patient rights, appropriate forms, and record keeping requirements. The intent of this standard is to ensure that facility staff who furnish care to residents who are hospice patients are provided information on the hospice philosophy and approach to care, much in the same way that home caregivers are routinely provided information on the hospice philosophy and approach to care. It is the hospice's responsibility to coordinate the trainings with representatives of the facility. It is also the hospice's responsibility to determine how frequently training needs to be offered in order to ensure that the staff furnishing care to hospice patients are oriented to the philosophy of hospice care.

We believe that the intent of the requirement to educate facility staff about hospice care continues to be an appropriate regulatory requirement. However, we believe that, as currently written and implemented, this requirement may create duplication when multiple hospices provide care to the residents of a single facility. Furthermore, by assigning sole responsibility for this effort to hospice providers, this requirement may impede joint hospice-facility collaboration and training innovations. Creating duplicative efforts and impeding collaboration may increase hospice burden without improving the care of hospice patients. Therefore, we believe that it is appropriate to revise the current requirement.

Specifically, we propose to remove § 418.112(f) and add a new requirement at § 418.112(c)(10), “Written agreement,” to address this issue. Moving the requirement for facility staff orientation to the standard related to the written agreement established between hospices and facilities would ensure that both entities negotiate the mechanism and schedule for assuring orientation of facility staff. Additionally, enabling hospices and facilities to negotiate their now shared role would encourage collaboration between both entities, avoid duplication of efforts with other hospices that are orienting the same facility staff, and provide incentives to facilities to become more engaged in the hospice orientation process for facility staff.

We are seeking public comment on all of the proposed hospice changes. In addition, we note 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 are soliciting public comments on additional regulatory reforms for burden reduction in future rulemaking. Specifically, we are seeking public comment on additional proposals or modifications to the proposals set forth in this rule that would further reduce burden on hospices and create cost savings, while also preserving quality of care and patient health and safety. Consistent with our “Patients Over Paperwork” Initiative, we are particularly interested in any suggestions to improve existing requirements, within our statutory authority, where they make providing quality care difficult or less effective. We also note that such suggestions could include or expand upon comments submitted in response to the RFI that was included in the FY 2018 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements. Public comments in response to this RFI can be found at the following link:
https://www.regulations.gov/document?D=CMS-2017-0062-0001.
Public comments on the RFI can be found by searching for the terms “RFI” or “request for information” in the aforementioned 2017 payment regulation docket on
www.regulations.gov.

The most useful comments will be those that include data or evidence to support the position, offer suggestions to amend specific sections of the existing regulations, or offer particular additions.

Contact:
Danielle Shearer, 410-786-6617.

D. Hospitals

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

On May 16, 2012, we published a final rule, entitled “Reform of Hospital and Critical Access Hospital Conditions of Participation” (77 FR 29034). In that rule, we finalized changes to the requirements of the “Governing body” CoP, § 482.12, and adopted a policy to allow one governing body to oversee multiple hospitals in a multi-hospital system. We noted in this rule that the regulations, as finalized, were intended to provide systems that own two or more hospitals with an option, but not a requirement, to use a system governing body for two or more hospitals. In those instances where a system believes that its interests are best served by using a system governing body legally responsible for two or more hospitals, under the CMS regulations, that system will have the flexibility to do so, just as system that owns two or more hospitals will have the flexibility to continue with the model of a separate governing body for each hospital in its system if it determines that course would best serve its interests.

After publication of the May 2012 final rule, we received a considerable amount of feedback regarding our responses in the rule (77 FR 29061) where we discussed our interpretation of the Medical staff CoP at § 482.22 as requiring that each hospital have its own independent medical staff despite the arguable ambiguity of the regulatory language. It was brought to our attention that, over the years, this apparently ambiguous language might have led some stakeholders to interpret § 482.22 as allowing for separately certified hospitals, as members of a multi-hospital system, to share a unified and integrated medical staff. This eventually led to us proposing a requirement in a February 7, 2013 proposed rule, entitled “Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction—Part II” (78 FR 9216), which proposed to prohibit the use of a unified and integrated medical staff subject to a system governing body.

In the May 12, 2014 final rule, Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction (79 FR 27105) that followed, and after carefully considering all of the arguments for and against allowing a system that owns two or more hospitals to use a unified and integrated medical staff structure for its member hospitals that are subject to a common system governing body, we came to the conclusion that it was in the best interest of hospitals, medical staff members, and patients for us to modify the proposed prohibition on the use of a unified and integrated medical staff for a multi-hospital system and its member hospitals so as to enable the medical staff of each hospital that is subject to a common system governing body to voluntarily integrate itself into a larger system medical staff.

The fact that many hospital systems had been using a unified medical staff model for a number of years, without evidence showing that such a model was detrimental to patients or decreased the quality of care delivered, was a major factor in our decision to allow hospitals and their respective medical staffs the flexibility to decide which medical staff framework worked best for

their particular situations. We received a large number of comments from individual physicians as well as national and State physician organizations that supported our proposed changes to reaffirm and make more explicit the requirement that each hospital to have its own medical staff, specifically those hospitals that are part of a multi-hospital system. These commenters stated they believe that allowing a multi-hospital system to have a unified and integrated medical staff instead of separate medical staffs for each hospital would destroy the concept of medical staff self-governance that is “a basic requirement” for TJC hospital accreditation and which is “mandated by some states.” Additionally, there were some comments from individuals as well as hospital leaders that stated that while they support the proposed requirement overall, they believe that there should be some allowance for hospitals within a system to share medical staff bylaws, rules, and regulations.

However, these arguments against allowing this flexibility through the CoPs did not provide any evidence that having a single and separate medical staff for each hospital within a system was inherently superior, particularly in the areas of patient safety and quality of care, to the unified and integrated medical staff model for two or more hospitals subject to a system governing body. We weighed this argument against the comments from the physician leaders and members of unified and integrated medical staffs who provided testimony and anecdotal evidence for the benefits of this type of structure. Additionally, we considered preliminary evidence that appeared to show that hospitals using a unified medical staff might be achieving some success in reducing Hospital-Acquired Conditions (HACs), Healthcare-Associated Infections (HAIs), and readmissions, and in improving patient safety and outcomes. During our preliminary development of this rule, we carefully considered any additional areas where we could provide further flexibility and reduce regulatory burden for hospitals. We were particularly interested in those areas that we had not considered or proposed in the previous rulemaking efforts discussed. As we noted with regard to the use of a unified medical staff model under a system governing body, much of the evidence and testimony provided to us at that time focused on observed improvements in patient safety, quality of care, and overall patient outcomes. In the May 2014 final rule previously referenced, one public commenter, writing on behalf of a multi-hospital system that the commenter references as the largest in their State, stated that “we believe the concept of a single medical staff has substantially contributed to our success as an integrated delivery system and has accelerated our quality, safety and efficiency performance.” The commenter also cited the system's achievements, which the commenter stated that they believe were a result of this single and integrated medical staff model: Core measures in the top quartile with excellent value-based purchasing scores according to CMS; lower in-hospital mortality rates that are statistically significant, that is, 17 percent lower than expected; lower hospital readmission rates that are statistically significant, that is, 15 percent lower than expected; and the second lowest congestive heart failure readmission rate in the nation, according to published CMS data.

Since those rules were published, we have not received any negative feedback on the regulatory changes or any evidence that the use of a unified medical staff model is detrimental to patients and their care. And because the potential benefits to using such a system appear to point to patient safety and quality of care specifically, we began to look at two areas in the CoPs for possible revision along these lines, two areas that we believe have the most direct impact on ensuring and promoting a culture of safety in hospitals—QAPI and infection control. We believe that applying the unified model to a hospital's QAPI program and/or a hospital's infection control program would be a natural progression for a multi-hospital system currently using a system governing body and a unified medical staff. By allowing a system governing body the option of unifying and integrating its various member hospital QAPI programs and/or infection control programs into unified programs incorporating each individual hospital's QAPI program and/or infection control program (and thus applying the greater resources of the system to each hospital's QAPI program and/or infection control program), we believe a system might be able to more efficiently and effectively disseminate innovations, solutions, and best practices for patient care to each of its member hospitals through these respective unified programs. The Health Research and Educational Trust, in partnership with the American Hospital Association in a March 2010 publication entitled, “A Guide to Achieving High Performance in Multi-Hospital Health Systems,” identified specific best practices associated with health systems (
http://www.hpoe.org/Reports-HPOE/highperformance3.2010.pdf
). The publication stated that “due to the size and breadth of their organizations, multi-hospital health system leaders have significant impact on the quality of health care in the United States. More than half of all U.S. hospitals belong to multi-hospital health systems, and about 60 percent of all hospital admissions occurs in system hospitals. While a wide range of quality improvement mechanisms can be applied in individual hospitals, there has been a lack of actionable information that leaders of multi-hospital systems can leverage to improve quality across their systems.”

Therefore, we propose to apply this same level of flexibility and regulatory burden reduction to a hospital's QAPI program as an option for system governing bodies that directly control and are legally responsible for two or more separately certified hospitals. As with our allowances for system governing bodies and unified medical staffs noted previously, we believe that system governing bodies that are legally responsible for two or more separately certified hospitals should be given the flexibility to determine which model of a QAPI program works best for their individual member and separately certified hospitals. We also believe that, in addition to the efficiencies that might be gained in the management and administration of QAPI programs through the increased resources of the hospital system, there might also be significant improvements in patient safety and outcomes to be achieved through such resources. Allowing for a unified and integrated QAPI program for its member hospitals would provide a system governing body with the needed flexibility and ease of administration to more readily apply the best practices and innovations learned and developed at one hospital to other hospitals subject to the same system governing body that might be facing the same problem-prone areas of patient care. We believe that by allowing system governing bodies this regulatory option, greater communication between member hospitals would be fostered so that a culture of patient safety and quality care could then be more fully integrated throughout the system. Given this flexibility and opportunity for integration, we believe that member hospitals subject to the same system governing body would replace the approach of each hospital operating within its own “silo,” a still all-too-

common operating standard, even within multi-hospital systems, that thwarts advances and innovations in improving patient care across the system.

We propose 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. Our expectation is that the focus on quality assessment, performance improvement, and patient safety within a certified hospital that is part of a unified and integrated QAPI program would be maintained and enhanced through the benefits of such integration.

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

Hospital Medical History and Physical Examination Requirements

The current CoP at § 482.22, “Medical Staff,” requires that a hospital have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. At § 482.22(c)(5), the hospital medical staff bylaws must include a requirement that a H&P be completed and documented for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services. The bylaws must also include a requirement that an updated examination of the patient, including any changes in the patient's condition, be completed and documented within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the H&P are completed within 30 days before admission or registration. These medical staff bylaws requirements addressing patient H&Ps form the basis for similar requirements in the hospital CoPs at § 482.24, “Medical Record Services,” and § 482.51, “Surgical Services.”

Current hospital H&P requirements were proposed and finalized between 2005 and 2007, and similar ASC requirements were finalized 1 year later. According to a February 28, 2017, Centers for Disease Control and Prevention (CDC) National Health Statistics Report (Hall MJ, Schwartzman A, Zhang J, Liu X. Ambulatory surgery data from hospitals and ambulatory surgery centers: United States, 2010. National health statistics reports; no. 102. Hyattsville, MD: National Center for Health Statistics. 2017), in 2010, 28.6 million ambulatory surgery visits to hospitals and ASCs occurred, with an estimated 48.3 million surgical and nonsurgical procedures performed. The report also states that an estimated 25.7 million (53 percent) ambulatory surgery procedures were performed in hospitals and 22.5 million (47 percent) were performed in ASCs during this time. Further, the report found that the most frequently performed procedures (for both ASCs and hospital outpatient/ambulatory surgery departments) included endoscopy of large intestine (4.0 million), endoscopy of small intestine (2.2 million), extraction of lens (2.9 million), insertion of prosthetic lens (2.6 million), and injection of agent into spinal canal (2.9 million). These statistics, which also show similarities between the characteristics of patients seen by ASCs and hospital outpatient/ambulatory surgery departments, combined with the evidence already discussed in section II.B.2, “Patient Admission, Assessment and Discharge” (§ 416.52(a)(1), (2), (3) and (4)) have led us to conclude that we should propose a less burdensome option for the assessment of a patient prior to a hospital outpatient/ambulatory surgery or procedure for specific patients and procedures.

Because the hospital H&P requirements apply to all hospital patients (not just ambulatory surgery patients, as in ASCs) and because these requirements are contained under three separate CoPs, any proposed hospital requirements for pre-surgical assessments in lieu of the current requirements for a comprehensive H&P would need to be structured somewhat differently than those proposed for ASCs. However, we are basing certain aspects of the proposed hospital requirements on those proposed for ASCs in order to take into account some of the similarities of the two provider types.

We would revise the current requirements at § 482.22(c)(5)(i) and (ii) with respect to medical staff bylaws 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 oromaxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy. We propose 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 are also proposing 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 propose 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 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 are proposing 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.

The current CoP at § 482.51, “Surgical Services,” contains provisions at § 482.51(b)(1)(i) and (ii) that require, prior to surgery or a procedure requiring anesthesia services and except in the case of emergencies that a medical history and physical examination must be completed and documented no more than 30 days before or 24 hours after admission or registration an updated examination of the patient, including any changes in the patient's condition, must be completed and documented within 24 hours after admission or registration when the medical history and physical examination are completed within 30 days before admission or registration. We are revising these requirements to allow for an exception to them under proposed paragraph (b)(1)(iii), where we propose 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.

As we did in the ASC section's discussion of these proposed changes to the H&P requirements, we request comment on whether there are any evidence-based exceptions or specific guidelines, such as for particular patient conditions or surgical procedures, that would prohibit this level of discretion for determining those hospital outpatient surgery patients who would not require a comprehensive H&P prior to outpatient surgeries or procedures.

Contact:
CDR Scott Cooper, USPHS, 410-786-9465.

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

In the June 1986 final rule, Medicare and Medicaid Programs, Conditions of Participation for Hospitals (51 FR 22010), we finalized a regulation to recommend that a hospital's medical staff attempt to secure autopsies in all cases of unusual deaths and of medical-legal and educational interest. Hospitals are further required to define a mechanism for documenting permission to perform an autopsy, and they must have a system for notifying the medical staff, and specifically the attending practitioner, when an autopsy is being performed. In that final rule, we stated that autopsies were an essential educational tool which contributed to the quality of care furnished by a hospital. Medical-legal investigative autopsies are conducted by a coroner's or medical examiner's office to determine the circumstances under which someone died and combine a scientific inquiry into a death under a coroner's or medical examiner's legal jurisdiction (
https://www.cdc.gov/phlp/publications/topic/coroner.html
).

Although the regulations specify that hospitals should attempt to secure permission to perform autopsies in certain cases, each state has established specific standards, laws, and regulations regarding the performance of autopsies for medical-legal investigative purposes for hospital patients. According to CDC's Public Health Law Program, each State sets its own standards for what kinds of deaths require investigation and its own professional and continuing education requirements for individuals carrying out these investigations. For example, the Medicolegal Death Investigation system for the state of New York specifies the use of coroners and medical examiners, who have specific medical and residency qualifications. Maine's Medicolegal Death Investigation system only specifies the role of a medical examiner. Unlike the regulations of the individual States, § 482.22(d) does not provide specifics on who should perform an autopsy, nor does it delve into the specifics of the medical-legal investigation process. As with all other CoPs, our intention was not to be overly prescriptive or overly burdensome in our requirements. In this case, the individual States have more specific requirements than the CoPs.

After reexamining this CoP, and in an effort to reduce duplicative or redundant requirements for hospitals, we believe that it is appropriate to remove the requirement at § 482.22(d). We believe that more detailed, specific requirements regarding medical-legal investigations and autopsies for hospitals are more appropriately and more effectively covered by the individual State laws in which the hospital is located. Therefore, we propose to remove the requirement at § 482.22(d). However, we continue to believe that the performance of autopsies further advances medical knowledge.

Contact:
Alpha-Banu Wilson, 410-786-8687.

4. Infection Control (§ 482.42)

Similar to our proposal for a unified and integrated QAPI program for multi-hospital systems previously discussed, we believe that the same level of flexibility and regulatory burden reduction can be applied to a hospital's infection control program. We firmly believe that the same efficiency of administration, and improved patient outcomes, patient safety, and quality of care would be achieved in the infection control realm through a consistent system-wide approach as would be

allowed by this proposed rule. Our expectation is that the focus on infection control within a certified hospital that is part of a unified and integrated infection control program would be maintained and enhanced through the benefits of such integration, and that the trajectory toward continued reductions in infections would be continued.

Therefore, we propose 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.

We are specifically seeking 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.

Contact:
CDR Scott Cooper, USPHS, 410-786-9465.

5. 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))

Section 1883 of the Act permits certain small, rural hospitals to enter into a swing-bed agreement, under which a hospital or CAH can use its beds as needed, to provide either acute or SNF care. Swing-beds are beneficial when a patient is ready to leave the acute care level of a hospital stay, but still requires further skilled nursing care. They are often the only option in rural areas to provide this level of care. As defined in our regulations, a swing-bed hospital is a hospital or CAH participating in Medicare that has CMS approval to provide post-hospital SNF care and meets certain requirements. 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 hospital CoPs at § 482.58(a)(1) and (2) specify that hospitals providing swing-bed services must be located in a rural area and have less than 100 beds. Section 482.58(a)(1) excludes from the count beds for newborns and beds in intensive care type inpatient units, and § 482.58(a)(2) requires that the hospital be located in rural area, which includes all areas not delineated as “urbanized” areas by the Census Bureau, based on the most recent census.

The CAH CoPs at § 485.645(a)(2) state that a CAH must not maintain more than 25 inpatient beds that may be used for the provision of inpatient or swing-bed services, and as required at § 485.635(b)(1)(ii), the CAH must furnish acute care inpatient services to patients who present to the CAH for treatment, so long as the CAH has an available inpatient bed and the treatment required to appropriately care for the patient is within the scope of services offered by the CAH (State Operations Manual, Appendix W).

Hospitals and CAHs must both meet eligibility requirements to be granted approval from CMS to provide 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.

The long-term care requirements under 42 CFR part 483 frequently reference residents given the average length of stay in long-term care facilities (28 days for skilled nursing facilities and 835 days for nursing homes) (Medicare Skilled Nursing Facility (SNF) Transparency Data (CY2013),
https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2016-Fact-sheets-items/2016-03-09.html#
; Centers for Disease Control and Prevention, Nursing Home Care FastStats,
https://www.cdc.gov/nchs/data/series/sr_03/sr03_038.pdf
). However, individuals receiving swing-bed services in a hospital or CAH are receiving SNF services and generally have shorter length of stays, with an the average length of stay of 11.4 days (Centers for Medicare & Medicaid Services, Office of Enterprise Data and Analytics, 2016). Note that this is still less than the average 28-day length of stay in a SNF. While we understand that some patients receiving swing-bed services in a hospital or CAH may have longer than average length of stays, 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. Thus, we propose 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. The resident may perform services for the facility, if he or she chooses.

The current requirement for LTCFs also states that residents of these providers who are receiving swing-bed services who choose to perform services for the facility may do so when the facility has documented the need or desire for the resident to work in the plan of care; the plan specifies the nature of the services performed and whether the services are voluntary or paid; compensation for paid services is

at or above prevailing rates; and the resident agrees to the work arrangement described in the plan of care. Provided that those receiving hospital and CAH swing-bed services are not residents and spend a limited amount of time receiving swing-bed services, we have determined that this is an unduly burdensome requirement. Swing-bed services are transitional SNF-level services provided on a temporary basis. As a result, only a limited number of the SNF requirements are applicable to these patients. Therefore, we believe that it is unlikely that patients receiving hospital and CAH swing-bed services would be assigned a job and given an opportunity to provide services at the hospital or CAH due to their relatively short length of stay. With the proposed removal of this requirement, a hospital or CAH may permit patients receiving swing-bed services to provide services at the facility upon mutual agreement between the patient and the facility; thus, we believe that this requirement is unnecessary. 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. In addition, in the absence of these requirements, we believe patients' rights requirements for hospitals at § 482.13 and CAHs providing swing-bed services at § 485.645(d)(3) (which incorporates the long-term care requirements that patients be free from abuse, neglect and exploita

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2018-19599. Public record. Not legal advice.